Gsk Case Study & Pr Plan
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GlaxoSmithKline Public Relations Plan & Case Study
GlaxoSmithKline Healthcare Reform & Accessibility to Medicines: Public Relations Plan & Case Study
by Jill
Leigh Bullock
Leigh Publishing Publicist & WVU Graduate Student To Learn More About Leigh Publishing Contact [email protected]
www.leighpublishing.com
Case Study & Public Relations Plan provided in conjunction with the Perley Isaac Reed School of Journalism Integrated Marketing Communication Master’s Program at West Virginia University
Integrated Marketing Communications 618: Public Relations Dr. Debra Davenport October 26, 2009
GlaxoSmithKline Public Relations Plan & Case Study
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GlaxoSmithKline Public Relations Plan & Case Study Appendix A: GSK Corporate Responsibility Report, 2008
Do more, feel better, live longer
August 2009 Interim Update Updates to information in our 2008 Corporate Responsibility report published in March 2009 have been inserted into the relevant sections of the report and are highlighted in blue boxes in a similar style to this text.
Our responsibility 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK Tel: +44 (0)20 8047 5000
Source: Retrieved October 24, 2009, from www.gsk.com/responsibility/downloads/GSK-CR-2008-full.pdf
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Corporate Responsibility Report 2008 Contents You have downloaded the full Corporate Responsibility Report 2008.
Corporate responsibility at GSK
3
Research practices
104
Message from the CEO
4
105 106 107 108
Our key issues
10
Emerging technologies – Cloning technology and stem cell research – Genetic research – Collaborative research on emerging technologies
Corporate responsibility governance
11
Animal research
109
13
Human tissue research
115
21
Medical governance
116
23
Clinical research – Planning and approval – Informed consent – Post-trial treatment – Clinical trials in the developing world
117 118 119 120 121
Public disclosure of clinical research
122
Patient safety – Patient safety governance framework – Collecting and reporting safety data – Performance
125 126 127 132 133
Our Corporate Responsibility Principles
6
Business case for corporate responsibility
8
Stakeholder engagement About our reporting Benchmarking Assurance and internal audit
25
Corporate responsibility data summary
27
Resources and downloads
30
Contribution to global health
31
The cost of disease
32
The role of vaccines
33
Treating ill health
35
Disease awareness and prevention
39
Investing in R&D
44
! "#
of research participants
46
Working with healthcare professionals
134
48
Training and auditing
135
Q&As
51
Case studies
138
Q&As
140
Access to medicines
53
Our approach and contribution
55
The role of others Developing countries
57 59
Ethical conduct
142
Code of Conduct and business ethics
143
60 71 73 75 79
Marketing ethics – Relationships with healthcare professionals – Direct-to-consumer advertising Training and awareness – Leading by example – Performance and plans
145 147 151 154 156 157
86
Monitoring and compliance
159
88
Case studies
163
Intellectual property
89
Q&As
165
The future
93
– Research and development – Public-Private partnerships – Product registrations – Preferential pricing – Pricing in middle-income countries Developed countries Pricing our medicines
Response to assurance recommendations
96
Case studies
98
Q&As
101
Source: Retrieved October 24, 2009, from www.gsk.com/responsibility/downloads/GSK-CR-2008-full.pdf
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.) Corporate Responsibility Report 2008 Contents
Supply chain
167
Responsibility and our supply chain – Human rights clause – Choosing suppliers – Monitoring and engagement – Supplier diversity – Fair treatment of suppliers
168 170 171 172 176 178
Maintaining quality
179
Security of supply
180
Counterfeiting
181
Case studies
184
Q&As
185
Environmental sustainability Plan for excellence – Targets – The journey to sustainability
186 187 188 190
Managing EHS and sustainability – EHSS vision and policy – Training and awareness – Audits and compliance – Reward and recognition – Management of EHSS
192 193 194 196 198 199
Environmental fundamentals – Wastewater – Hazardous and non-hazardous waste – Contaminated land – Emissions to air – EHSS in business processes – Supplier performance
200 201 204 210 211 216 217
Sustainability – Materials – Climate change and energy – Water use – Product stewardship – Packaging Open and transparent relations – Stakeholder engagement – EHSS reporting – Assurance – GSK response to assurance
218 219 221 230 233 240 241 242 243 244 247
Q&As
249
Environmental metrics
250
Our people
255
Our culture and behaviours
257
Restructuring
258
Consultation
259
Communication
260
Diversity and inclusion
263
Training and development
267
Reward and recognition
269
Health, safety and wellbeing – Health and safety management – Hazard assessment and communication – Safety programmes – Health and wellbeing programmes – Health and business continuity – Training and awareness – Performance
270 271 273 275 278 280 281 282
Case studies
288
Q&As
290
Human rights Employees
292 293
Suppliers
294
Communities
295
Society
296
Activities in sensitive countries
297
Public policy and patient advocacy
298
Our approach to external affairs
299
Public policy activity in 2008 – Advocacy on healthcare and disease prevention – Advocacy on research practices – Advocacy on patient safety – Advocacy on intellectual property – Advocacy on pricing and competitiveness
301 302 304 306 307 309
Political contributions and lobbying expenditures
310
Patient advocacy – Transparency – Understanding patients – Developing industry standards – Advocacy in 2008
312 314 315 316 317
Q&As
318
Source: Retrieved October 24, 2009, from www.gsk.com/responsibility/downloads/GSK-CR-2008-full.pdf
GlaxoSmithKline Public Relations Plan & Case Study Appendix A: GSK Corporate Responsibility Report, 2008 (cont.) Corporate Responsibility Report 2008 Contents
Our work with communities
319
Community investment
321
Preventing disease – Eliminating lymphatic – Personal Hygiene And Sanitation Education (PHASE) – Local programmes
323 324 325 326
Building community capacity – Combating HIV/AIDS – Positive Action – Combating malaria – Africa Malaria Partnership – Local programmes – Responding to disasters around the world
327 328 329 330 332
Supporting science education
333
Our plans
335
Source: Retrieved October 24, 2009, from www.gsk.com/responsibility/downloads/GSK-CR-2008-full.pdf
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK
Corporate Responsibility Report 2008 Corporate responsibility at GSK Corporate responsibility (CR) is central to our business. We aim to operate in a way that reflects our values, to understand and respond to stakeholder views and to connect business decisions to ethical, social and environmental concerns. We seek to minimise the negative impacts and maximise the benefits of our business. Read a message from our CEO on the importance of CR at GSK. Every GSK employee is responsible for upholding our values and maintaining high ethical standards. Our Corporate Responsibility Principles define our approach to our key responsibility issues and provide guidance for employees on the standards to which the company is committed. We communicate with our people to underline our commitment to corporate responsibility and to update them on our progress. We also engage with our external stakeholders ± including healthcare professionals, investors, patients, nongovernmental organisations, local communities and suppliers ± to identify key issues and to gain feedback on our approach to corporate responsibility. Our business makes a valuable contribution to society through the medicines and vaccines we produce which improve people¶s lives. However, we know that the research and development, manufacture and sale of medicines and vaccines raise ethical issues. Consequently, the pharmaceutical industry is subject to a high level of public scrutiny and sometimes critical media coverage. We aim for the highest ethical standards and we regularly report on our progress. This is essential for maintaining good relationships with our stakeholders, achieving the goals of our strategic priorities and ensuring the future sustainability of our business. It also supports our inclusion in key sustainability indices such as the FTSE4Good index and Dow Jones Sustainability Index. See how we scored in industry and investor benchmarks. Our Corporate Responsibility Principles define our approach to our key responsibility issues and provide guidance for employees on the standards to which the company is committed. Read about our management structures and processes for advancing progress on our CR Principles. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Message from the CEO
Corporate Responsibility Report 2008 Message from the CEO A new mindset Welcome to GSK¶s Corporate Responsibility report which provides information on our activity and performance during 2008. We want to be a company that is forward looking, innovative and willing to try new approaches and partnerships; a company that is constantly looking for new and sustainable ways to increase access to our medicines and vaccines, especially for those least able to pay. We have made significant progress in helping to address global healthcare challenges. For example, over the past ten years we have donated over one billion tablets to the programme to eliminate lymphatic filariasis, a debilitating tropical disease and we are doubling manufacturing capacity to 600 million tablets a year. Our commitment to preferential pricing means we offer our AIDS and malaria medicines at not-for-profit prices in the world¶s poorest countries. We also supply our vaccines to organisations such as GAVI and UNICEF at preferential prices, typically 10-20 per cent of the prices in developed countries. But for every success story, there are examples of where we could do more. As I review our performance, I believe it is time for a new mindset in our industry and a new contract with society. In these difficult economic times it is a challenge to think beyond short-term performance. But we must look to the long-term and not be distracted by our own economic problems when the needs of the developing world remain just as pressing. To begin with, there are four areas where we can show we are going to do things differently. First, we are exploring a more flexible approach to intellectual property rights to incentivise much needed research into medicines for 16 neglected tropical diseases where there is a severe lack of research. One option is a Least Developed Country (LDC) µpatent pool¶ in to which we would put our relevant small molecule compounds, process patents or other knowledge, and which would allow others access to develop and produce new products. Secondly, on 1 April 2009 we will reduce our prices for patented medicines in the 50 poorest countries in the world, the LDCs, so they are no higher than 25 per cent of the developed world price. Where possible we will reduce our prices further while ensuring we cover our manufacturing costs so this offer is sustainable. We also recognise the challenge in middle-income countries where there is a wide disparity in incomes and ability to pay. Here our intention is to work on a case-by-case basis recognising that there is no µone size fits all¶ solution to improving access to medicines in these countries. Thirdly, we will seek out partnerships and open the doors of our developing world research centre in Spain. We already know what partnership can achieve ± for example, we successfully trialled a malaria vaccine candidate in partnership with the PATH¶s Malaria Vaccine Initiative and the Bill and Melinda Gates Foundation. If we extend this approach the benefits will be huge. Fourthly, working with partners such as NGOs, we will reinvest 20 per cent of the profit we make from selling medicines in LDCs to support the strengthening of healthcare infrastructure in these countries. Our sales in LDCs are relatively low so this profit is limited; initially this funding will amount to 1 to 2 million annually. But by our action we hope to send a signal to all multi-national companies operating in LDCs to join us and make a meaningful change in these countries. In all developing countries we must transform GSK into a local company addressing local healthcare needs. Our Brazilian business is leading the way ± supplying vaccines and sharing technical expertise to help build local capacity. We will not forget that significant healthcare challenges exist in developed countries too. We must work in partnership to create a virtuous circle, where industry gets rewarded for demonstrating genuine innovation,
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
healthcare payers get value-for-money because our medicines save them from high-cost healthcare interventions, and more patients get the medicines they need. Of course, access to medicines is not the only issue that counts. We want GSK to be recognised around the world - by all stakeholders - as a company with the highest ethical standards. We made good progress in 2008. We committed to stopping all corporate political contributions from 2009. Our decision to report more fully on our funding for medical education, patient groups and payments to physicians, will increase transparency and provide reassurance to stakeholders. Reflecting our commitment to animal welfare, we took a voluntary decision to end research in great apes, the highest-order of animals next to humans. It is time for a new mindset in our industry and a new contract with society. With the support of other pharmaceutical companies and partners outside the industry, I believe significant improvements in human health can really be achieved. Andrew Witty, CEO Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Our Corporate Responsibility Principles
Corporate Responsibility Report 2008 Our Corporate Responsibility Principles Our Corporate Responsibility Principles identify our key responsibility issues and provide guidance for employees on the standards to which GSK is committed: Employment practices We will treat our employees with respect and dignity, encourage diversity and ensure fair treatment through all phases of employment. We will provide a safe and healthy working environment, support employees to perform to their full potential and take responsibility for the performance and reputation of the business. Read more about our employment practices. Human rights We are committed to upholding the UN Universal Declaration of Human Rights, the OECD guidelines for Multi-National Enterprises and the core labour standards set out by the International Labour Organization. We expect the same standards of our suppliers, contractors and business partners working on GSK¶s behalf. Read more about our approach to human rights. Access to medicines We will continue to research and develop medicines to treat diseases of the developing world. We will find sustainable ways to improve access to medicines for disadvantaged people, and will seek partnerships to support this activity. Read about our approach in Access to medicines. Leadership and advocacy We will establish our own challenging standards in corporate responsibility, appropriate to the complexities and specific needs of our business, building on external guidelines and experience. We will share best practice and seek to influence others, while remaining competitive in order to sustain our business. Community investment We will make a positive contribution to the communities in which we operate, and will invest in health and education programmes and partnerships that aim to bring sustainable improvements to under-served people in the developed and developing world. Read about our work with communities. Engagement with stakeholders We want to understand the concerns of those with an interest in corporate responsibility issues. We will engage with a range of stakeholders and will communicate openly about how we are addressing CR issues, in ways that aim to meet the needs of different groups while allowing us to pursue legitimate business goals. Read about our stakeholder engagement. Standards of ethical conduct We expect employees to meet high ethical standards in all aspects of our business, by conducting our activities with honesty and integrity, adhering to our CR principles, and complying with applicable laws and regulations. Read about ethical conduct. Research and innovation In undertaking our research and in innovating: We may explore and apply new technologies and will constructively engage stakeholders on any concerns that may arise. We will ensure that our products are subject to rigorous scientific evaluation and testing for safety, effectiveness and quality We will comply with or exceed all regulations and legal standards applicable to the research and development of our products Read more about our research practices. Products and customers We will promote our products in line with high ethical, medical and scientific standards and will comply with all applicable laws and regulations. Read more about our marketing ethics.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Caring for the environment We will operate in an environmentally responsible manner through systematic management of our environmental impacts, measurement of our performance and setting challenging performance targets. We will improve the efficiency of all our activities to minimise material and energy use and waste generated. We aim to find opportunities to use renewable materials and to recycle our waste. Read more about environmental sustainability. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Business case for corporate responsibility
Corporate Responsibility Report 2008 Business case for corporate responsibility Demonstrating that our practices are responsible and ethical benefits the business in the following ways: An improved reputation and greater trust in GSK products The ability to attract, retain and motivate talented people. This is becoming increasingly important as fewer young people in our major markets choose science-based careers Constructive engagement with stakeholders. This helps us to prevent avoidable conflict and identify innovative approaches that benefit GSK and wider society Greater access to markets and the ability to influence healthcare policy through improved relationships with regulators and healthcare payers. Helping governments to increase access to medicines and resolve healthcare challenges is particularly important Greater ability to anticipate and prepare for legislative changes and maintain a competitive advantage Helping to maintain support for the intellectual property system by finding innovative ways to increase access to medicines Reduced costs and more efficient use of resources through increased environmental efficiency
Our business strategy Our business performance and development are driven by three strategic priorities which are supported by our corporate responsibility activities. We believe that corporate responsibility should be managed as part of our overall business strategy and through our day-to-day business operations. For this reason we do not have a separate corporate responsibility strategy at GSK. Corporate responsibility and our strategic priorities
We have established strategic priorities which we believe will increase growth, reduce risk and improve our long-term financial performance: Grow a diversified global business Deliver more products of value Simplify the operating model We believe these priorities will enable us to navigate the coming years more successfully and retain our leading-edge position as a company able to meet patients¶ and healthcare providers¶ needs into the future. Running our business in a responsible way is fundamental to our success and inseparable from our strategic priorities. We want to work in way that reflects our values, seeks to understand and respond to stakeholder views and connects our business decisions to ethical, social and environmental concerns. In this way we aim to minimise the negative impacts and maximise the positive benefits of our business.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Our key issues
Corporate Responsibility Report 2008 Our key issues Our CR reporting is focused on the most material (significant and relevant) issues for our business. The following factors influence our materiality assessment: Our business strategy Our risk management processes. Stakeholder interest, including investor feedback Changes in our business and operations, for example the types of product we produce or the locations in which we operate. Existing and proposed legislation Public opinion and press coverage We have identified the following responsibility issues as most material to GSK: The contribution our core business makes to health through research, development, manufacture and the sale of medicines and vaccines Increasing access to medicines in under-served communities Ethical standards in research and development, and sales and marketing Our environmental impact, particularly climate change Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Corporate responsibility governance
Corporate Responsibility Report 2008 Corporate responsibility governance Our Corporate Responsibility Committee (CRC) of Non-Executive Directors provides high-level guidance on our approach to CR. The CEO and members of the Corporate Executive Team (CET) are accountable for responsible management of the business and participate in CRC meetings. During 2008 the Committee members were Sir Christopher Gent (Chair), Dr Stephanie Burns, Dr Daniel Podolsky, Sir Ian Prosser and Tom de Swaan. The Committee meets three times a year to review our policies and progress on our CR Principles. The Committee reviews our performance against five of our CR Principles annually. These are access to medicines, standards of ethical conduct, research and innovation, employment practices and community investment. Other Principles are discussed at least once every two years. The Committee reports its findings to the Board. Management of corporate responsibility
During 2008 the CRC reviewed GSK¶s activity in a number of areas, including access to medicines, community partnerships, humanitarian donations, employee volunteering, sales and marketing practices, disclosure of funding of medical education and patient advocacy groups, product safety and communication of clinical trial results, R&D on diseases of the developing world, use of animals in research, outsourcing of research, research in emerging markets, reduction of employee numbers through restructuring, employee consultation requirements and employment litigation in the US. The Committee also reviews and signs off the annual performance information published on this website and our annual CR highlights document. To augment GSK's engagement with stakeholder opinion, in March 2009 Sophia Tickell was appointed as an external advisor to the Corporate Responsibility Committee. Sophia is an Executive Director and member of the Leadership team at SustainAbility, a think tank and consultancy that seeks to enhance business engagement with social and environmental concerns. Sophia has extensive experience of constructively challenging companies to increase their understanding of societal expectations and to develop strategies to meet them. She has gained this experience in her work as a journalist in Latin America, through her work in
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
international development and her advocacy work at Oxfam and, most recently, through her direction of the investor-led Pharma Futures dialogues which aim to better align societal and shareholder value. Sophia will attend the meetings of the Corporate Responsibility Committee and advise the company in this capacity. Read more about the Corporate Responsibility Committee. Corporate responsibility risks Our Risk Oversight and Compliance Council (ROCC) coordinates the management of significant business risks. The ROCC also considers reputational and corporate responsibility risks. Read more about risk management and compliance at GSK. Management structure CR covers a very diverse range of issues at GSK so we believe it should be managed within our business functions, where the relevant subject experts work. We have a cross-functional team made up of representatives from key business areas which oversees development, implementation and communication of policies, including any responsibility elements, across GSK. The members are senior managers with direct access to our Corporate Executive Team. We have a small central CR team to coordinate policy development and reporting specifically with respect to CR, and to communicate with socially responsible investors and other stakeholders. Measuring performance We have established metrics and key performance indicators to track our performance on responsibility issues. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Stakeholder engagement
Corporate Responsibility Report 2008 Stakeholder engagement Stakeholder engagement and dialogue enables us to connect with the views and opinions of the societies in which we operate. It helps us identify important issues and shape our responses in the interest of our shareholders and wider society. Regular engagement means we are better informed of emerging and current issues and changing societal expectations. It provides an opportunity for us to voice our approach to responsibility issues, obtain important feedback and build trust. Most of this discussion takes place in the normal course of business. For example, our scientists regularly meet academics, researchers and other pharmaceutical companies through advisory boards and medical conferences. Here we describe how we engage with our stakeholders, give examples of our engagement in 2008 by stakeholder group and provide information on how we are responding to the feedback we receive. You will find further examples of our engagement with stakeholders throughout this website.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Stakeholder engagement How we engage
Corporate Responsibility Report 2008 How we engage Healthcare professionals We engage with healthcare professionals in many ways, including through our sales representatives and when running clinical trials. Read about our research and ethics policies governing relationships with healthcare professionals. Patients GSK researchers and scientists meet patients as part of our µFocus on the Patient¶ initiative. This engagement influences our understanding of diseases and our research priorities, read more in our case study.We also support the work of patient advocacy groups and we conduct market research via third parties to understand patient needs. Governments and regulators We engage in debate on legislation and seek to influence policy decisions that affect GSK. We also engage with governments on responsibility-related issues. Healthcare providers We engage with healthcare providers through our government affairs, marketing and access to medicines activities. Investors We meet regularly with investors and socially responsible investors. Read more about our investor engagement activities. Employees We seek feedback from our employees through regular surveys. We also consult employees on changes that affect them and discuss business developments through regional and national consultation forums. Local communities Our interactions with local communities are managed by individual GSK sites. Read more about our financial and practical support for communities . Multilateral agencies We engage with multilateral agencies through our access and public health initiatives. Non-governmental organisations (NGOs) We engage with international and local NGOs through our access , education and public health programmes and as part of our public policy work. We also engage regularly with animal welfare organisations. Read more about animal research at GSK . Scientific community and academic partnerships It is important for GSK to be part of scientific debates and we are involved in a number of academic collaborations. Suppliers We hold global and regional supplier review meetings where senior GSK managers address and interact with suppliers on key issues. Read more about our engagement with suppliers. Peer companies We engage with peer companies through membership of pharmaceutical industry organisations, for example
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Stakeholder engagement Engagement with employees
Corporate Responsibility Report 2008 Engagement with employees It is important that our employees know about our commitment to corporate responsibility, understand their responsibilities and keep up-to-date with our progress. Read about our approach to embedding an ethical culture at GSK. We keep employees informed about corporate responsibility through our myGSK intranet site and Spirit, our internal quarterly magazine, which feature articles on responsibility issues. Read about how we engage with employees on environment, health and safety issues. In 2008 at least nine articles on responsibility issues were published in Spirit. These included articles on environmental sustainability, community investments and our efforts to combat diseases of the developing world such as lymphatic filariasis. This year we published four editions of Spirit, distributing 33,500 copies of each edition internally. Additionally, during the year, an online version of the magazine was introduced on the intranet, offering access to more employees. We distributed our 2007 Corporate Responsibility Review with Spirit magazine and directly to the Corporate Executive Team and GSK Board, senior managers, site directors and all communications staff. News articles and icons on our intranet site were used to guide users directly to the Review. This year we have published a shorter CR Highlights document to direct people to this website. We are raising awareness of this online CR Report by publicising it on our website and the company intranet.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Stakeholder engagement Engagement with investors
Corporate Responsibility Report 2008 Engagement with investors We held 20 meetings with investors in 2008 to discuss responsibility issues. These comprised one-to-one meetings and teleconferences, and a socially responsible investment (SRI) roadshow.
Investor questions Some of the questions raised by investors about responsibility issues in 2008 concerned: Access to medicines Clinical trial results disclosure Clinical trials in the developing world Patient safety Our operations in sensitive countries. Read more about GSK¶s position on human rights Sales and marketing practices. Read more about marketing ethics at GSK Stem cell research Animal research including genetic engineering of animals Environmental issues including climate change and water pollution Political contributions We also disclose information on our greenhouse gas emissions through the Carbon Disclosure Project (CDP), an investor collaboration.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Stakeholder engagement Engagement with opinion leaders
Corporate Responsibility Report 2008 Engagement with opinion leaders Ipsos MORI survey GSK participated in the Ipsos MORI survey which rates companies according to CR experts¶ and NGOs¶ perception of their CR performance. In 2008 nearly three-quarters of the 41 people surveyed thought that GSK took its responsibilities seriously, maintaining the significant improvement made in 2007 compared with 2006. GSK was the seventh-highest rated company on this question (out of 26 companies). Three of 41 respondents spontaneously mentioned GSK as a leader in corporate responsibility; there were no spontaneous mentions of GSK last year. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corperate Responsibility at GSK Stakeholder engagement Engagement on access to medicines
Corporate Responsibility Report 2008 Engagement on access to medicines Engagement on issues relating to access to medicines during 2008 is described in the Access to medicines section. As well as the engagement during 2008, GSK conducted three formal stakeholder discussions during 2007 to get feedback on our approach to different issues relating to access to medicines . We engaged with influential individuals and organisations with expertise in this area, including NGOs, government representatives, journalists, academics, investors and industry organisations. The topics covered were: Increasing access to HIV/AIDS medicines in developing countries Expanding R&D into diseases of the developing world Increasing access to medicines in middle-income countries While we do not necessarily agree with all the comments made by participants, these sessions provided valuable feedback on our approach. Feedback on GSK¶s approach in developing countries Participants felt that GSK has a moral responsibility to make its products accessible to poor people and that access to medicines is also important to GSK¶s long-term business sustainability. It was felt that GSK¶s approach to increasing access in developing countries (R&D, preferential pricing and voluntary licensing) is appropriate, although participants would like GSK to invest more in R&D into diseases of the developing world and do more to remove obstacles to the supply of generic medicines in these countries. Participants urged GSK to collaborate more with other pharmaceutical companies to address access issues in developing countries. It was felt that an industry-wide approach could help to address issues more quickly and effectively. Feedback on GSK¶s approach in middle-income countries, Participants emphasised the importance of increasing access to medicines in middle -income countries (MICs) where there are still large numbers of very poor people. They encouraged GSK not to treat MICs as we would high-income countries. Participants felt that GSK does not have a clear strategy on access in MICs. They would like GSK to be clearer on its approach and objectives; in particular they would like to know if we regard MICs as significant commercial markets. It was pointed out that chronic diseases are a growing problem in MICs. It was suggested that GSK take a broad approach to access that encompasses all its medicines, not just those for high-profile diseases such as HIV/AIDS, malaria and TB. Read about the findings from these session in more detail.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility CR at GSK Stakeholder engagement Engagement on EHS
Corporate Responsibility Report 2008 Engagement on EHSS We have an Environment, Health and Safety and Sustainability Stakeholder Panel in the UK which has provided independent feedback on our performance since 2005. The panel of 13 members represents customers, suppliers, regulators, public interest groups and investors. Two senior EHSS representatives from GSK regularly participate and other GSK managers attend discussions on specific topics. The panel is facilitated by The Environment Council, an independent charity. The panel met in April and October 2008 to debate a range of issues including: The broad issue of sustainability GSK¶s position on nanotechnology Progress with climate change, process safety and green chemistry programmes GSK¶s plans for complying with the EU¶s Registration, Evaluation and Authorisation of Chemicals (REACH) legislation, mass efficiency improvement and pharmaceuticals in the environment We have been using the feedback from the stakeholder panel to inform our Environment, Health and Safety and Sustainability programme. The panel is also providing input to the new GSK Sustainability Council composed of senior managers from across GSK. Panel members provided feedback about the direction the panel should take and the effectiveness of the dialogue. They proposed that the panel should have a broader geographic reach. We have therefore added three new European panel members and are recruiting two more. The panel finds GSK honest and open in the discussions so they consider their participation to be valuable. However they commented that it takes GSK a long time to demonstrate changes that occur as a result of their suggestions and feedback. We value the feedback we receive from the panel and we will look for ways to speed up our response to their recommendations. Many of our sites also engage with stakeholders locally on EHSS issues, through activities such as open days, newsletters and community projects.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK About our reporting
Corporate Responsibility Report 2008 About our reporting Welcome to our 2008 Corporate Responsibility Report. This year we have reported on our activities and performance online, providing easy access to information on key issues plus the ability to build a custom version of our 2008 Report.
How we report We report our corporate responsibility activities and performance annually. This website contains a detailed account of our CR policies and performance in 2008. Selected performance information can also be downloaded, read more about how to use this website. We also publish Corporate Responsibility Highlights which provides an overview of our approach to CR. It is available in print. Data relate to worldwide operations for the calendar year 2008, except where stated. Environmental data are collected from all 79 of our Pharmaceutical, Consumer Healthcare and Nutritionals manufacturing sites, 14 of the 15 vaccines sites (one is not yet in operation), 22 of 31 Pharmaceutical and Consumer Healthcare R&D sites including five whose environmental data are included with their host sites (nine are too small or too new to warrant collection of environmental data in 2008), the US and UK headquarters buildings and 15 smaller offices and distribution centres. Injury and illness data are collected from all 79 of our Pharmaceutical, Consumer Healthcare and Nutritionals manufacturing sites, 14 of the 15 vaccines sites (one is not yet in operation), 29 of 31 Pharmaceutical and Consumer Healthcare R&D sites (two are considered too new to start reporting), the US and UK headquarters sites, 18 offices and sales groups with more than one million hours worked, and 46 of the smaller offices and distribution centres. Data in the environment and health and safety sections are independently assured by SGS. We use external guidelines to inform our reporting where relevant. We do not base our report on the Global Reporting Initiative (GRI) guidelines but we have produced a GRI index to show which elements of the guidelines are covered in the report and to aid comparison with other company reports. We have also joined the UN Global Compact and have provided an index to show how we are reporting in line with Global Compact expectations. Brandnames appearing in italics throughout this report are trademarks either owned by and/or licensed to GSK or associated companies.
Contact We welcome your feedback on any of the information contained in this report. Please contact us at: Corporate Responsibility GlaxoSmithKline plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom [email protected]
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Benchmarking
Corporate Responsibility Report 2008 Benchmarking GSK received the following ratings from benchmarking organisations:
Indexes Organisation:Access to medicines index - Access to Medicines Foundation and Innovest Strategic Value Advisers Rating: GSK was ranked highest in the index which assessed companies¶ contribution to improving access to medicines. GSK was the clear overall leader and was top in five of the eight categories assessed. Organisation: Dow Jones Sustainability Index Rating: GSK continued as a member of the Dow Jones Sustainability Index, which covers the top ten per cent of sustainable companies in each sector. GSK was awarded Silver Class and Sector Mover distinctions, improving from Bronze Class awarded in 2007. Classes are awarded to companies relative to the sector leader. Organisation: FTSE4Good Rating: GSK was included in the FTSE4Good Index. Organisation: Global 100 Most Sustainable Corporations - Innovest Strategic Value Advisors Rating: GSK was included in the 2009 list of the µGlobal 100 Most Sustainable Corporations¶. Companies are selected because they demonstrate capacity to address sector-specific environmental, social and governance risks and opportunities. Organisation: Business in the Community - CommunityMark Rating: GSK was one of 21 companies and the only manufacturing company to be awarded the new CommunityMark, following independent assessment, for outstanding community investment. The Mark is endorsed by the UK government and voluntary sector leaders and was given for our work at local and national level in the UK as well as for our larger international programmes. Organisation: Business in the Community - Environment Index Rating: GSK maintained its position in the Platinum League of the 2007 index which assessed 155 companies.
Other investor ratings Organisation: Ceres Rating: GSK was ranked 13th overall and 2nd in the pharmaceutical sector in Ceres¶s climate change governance ranking of 63 of the world¶s largest companies.
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Organisation: Storebrand Rating: GSK achieved Best in Class status for its leading environmental and social performance. Storebrand assesses indicators including corporate governance, marketing ethics, standards for business partners, occupational health and safety, environmental risk management and labour relations.
Reporting Organisation: Association of Chartered Certified Accountants (ACCA) Rating: GSK Corporate Responsibility Report 2007 was shortlisted for an ACCA award, which recognises transparency and credibility in reporting. Organisation: PwC Building Public Trust Award Rating: GSK was one of three companies short-listed for the µPeople Reporting¶ award, which assesses the extent to which publicly available information enables stakeholders. Organisation: SustainAbility Global Reporters benchmark Rating: GSK¶s 2007 report scored 66 per cent versus 54 per cent for the 2006 report, with improvements in every category and particularly accessibility and assurance. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Assurance and internal audit
Corporate Responsibility Report 2008 Assurance and internal audit External assurance of EHS activities The information we provide about environment, health and safety activities at GSK has been externally assured by independent, third-party assurers. Our reporting on environment, health and safety performance is assured by SGS, an external assurer. The assurance process includes verification of key environment, health and safety data through site visits and telephone calls to EHS professionals and review of systems and processes for collecting, collating, analysing and interpreting the data. Read the EHS assurance statement by SGS.
External assurance of access to medicines activities In our 2007 CR Report, information on access to medicines was externally assured. Read how we are responding to the recommendations made by the assurers on our access to medicines activity and reporting. This year we did not conduct assurance on the CR report other than that described above for the EHS section. We plan to conduct assurance of one new section of the report every other year, so a section of the 2009 report will be subject to external assurance.
Internal audit and assurance GSK has developed an assurance programme that provides a holistic assessment of internal control processes, risk management and audit within the company. A key part of this programme is an extensive and independent internal audit schedule, delivered by four specialist audit groups. These audits assess compliance with laws, regulations and company standards, and evaluate the effectiveness of the risk management process in identifying, managing and mitigating the more significant risks facing GSK. Global Internal Audit (GIA) is responsible for evaluating the financial and operational controls that ensure financial reporting integrity and safeguard assets from losses, including fraud Corporate Environment, Health, Safety and Sustainability (CEHSS) is responsible for assessing the management of health and safety risks and environmental impacts Global Manufacturing Supply Audit and Risk Management (ARM) assesses the quality and supply risks relating to manufacturing and supply chain processes for GSK commercial products Global Quality and Compliance (GQC) is responsible for assessing risks relating to medicines, vaccines and medical devices throughout the product development process, including the manufacture of clinical trial material The central assurance function is responsible for developing the assurance programme, and for ensuring that the GSK audit groups work together in the most efficient and effective way to deliver the audit schedule. Global Internal Audit audits the other three audit groups for alignment with the Institute of Internal Auditors¶ International Standards for the Professional Practice of Internal Auditing. The CEHSS, ARM and GCQ audit groups have additional responsibilities for the auditing of contract manufacturers and key suppliers to GSK. GSK employs approximately 150 full-time internal auditors across the four audit groups. Audits range in duration from two man-weeks for simple activities where the scope is limited, to several months for an audit involving complex or highly technical processes. The audit teams may also be supplemented by external
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
g p g y p y pp y experts with specific technical skills, or by the use of guest auditors from within the business. Audits are conducted based on the level of risk. They regularly assess the level of internal control for a number of responsibility areas, including: Animal research Business continuity planning Community investment Conduct of clinical trials Employment practices Environmental factors Ethical conduct Financial processes Health and safety Information technology Intellectual property Interactions with patient groups Manufacturing and supply chain standards Patient safety Sales and marketing practices When issues or control deficiencies are identified, the audit groups recommend processes for improvement. GSK managers develop corrective action plans to eliminate the causes of non-compliance and gaps in internal controls. The audit groups track these plans to completion and report results to senior management and the Audit Committee. Each audit group reports to the Audit Committee as part of the assurance programme, and provides an assessment of whether adequate controls are in place to manage significant risks. Any significant audit results are also reported to the Audit Committee at the earliest opportunity. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Corporate responsibility data summary
Corporate Responsibility Report 2008 Corporate responsibility data summary Metric
2004
2005
2006
2007
2008
Number of countries supplied with GSK preferentially priced ARVs 1
57
56
51
31
37
Number of Combivir and Epivir tablets shipped (millions)
66.4
126.3
86.3
85.0
70.0
-
-
120
183
279
0.65
0.65
0.65
0.54
0.54
Voluntary licences granted to generic manufacturers for GSK ARVs (cumulative total) 3
6
7
9
9
9
Value of products donated through GSK Patient Assistance Program in the US ( millions, 2008-2007 at cost, 2006-2004 at wholesale price (WAC)) 4
203
255
200
45
56
Expenditure on R&D ( billions)
2.9
3.1
3.5
3.3
3.7
GSK animal research facilities accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (cumulative total) 5
10
10
10
10
10
Number of trials published on the GSK Clinical Study Register (cumulative total)
143
2,125
2,760
3,089
3,273
Number of employees completing certification to the GSK Code of Conduct
9600
>12,000
>12,000
>14,000
>14,000
Number of contacts through our ethics compliance channels 6
2580
3644
5363
5265
3812
35
35
36
37
38
19.5
19.6
19.8
20.1
20.5
Access to medicines
Number of generic ARVs supplied under licence from GSK (millions) GSK Combivir not-for-profit price ($ per day) 2
Research and Development
Ethical conduct
Employment Women in management grades (%) Ethnic diversity - people of colour (US, %)
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Ethnic diversity - ethnic minorities (UK, %)
14.8
14.9
18.3
19.1
19.2
Lost time injury and illness rate (cases per 100,000 hours worked)
0.32
0.32
0.34
0.35
0.33
Number of contract manufacturers audited
35
41
36
55
53
Energy consumption (million gigajoules)
19
19
19
19
19
Water consumption (million cubic metres)
21
22
22
21
20
Ozone depletion potential from metered dose inhalers (tonnes CFC-11 equivalent) 7
464
273
182
136
88
Ozone depletion potential from production (tonnes CFC-11 equivalent)
59
51
33
15
5
Ozone depletion potential from refrigeration and other ancillary uses (tonnes CFC-11 equivalent)
3
3
1
1
<1
Volatile organic compound emissions (thousand tonnes)
5
5
4
4
4
Global warming potential from energy sources (thousand tonnes CO 2HTXLYDOHQW 8
1,667
1,717
1,704
1,702
1,722
Hazardous waste disposed (thousand tonnes)
71
67
70
72
54
Total community investment expenditure ( millions, 2008-2007 at cost, 2006-2004 at wholesale price (WAC)) 4
328
380
302
109
124
Value of humanitarian product donations, including albendazole ( millions, 2008-2007 at cost, 2006-2004 at wholesale price (WAC)) 4
57
41
38
7
12
Number of albendazole tablets donated for prevention of lymphatic filariasis (millions)
67
136
155
150
266
Environment
Community investment
1. Includes ARVs sold at not-for-profit and discounted prices. We are unable to collect data for the number of patients treated. 2. Includes freight and delivery costs. The Mpdecins Sans Frontiqres pricing report lists the average cost of generic equivalents. 3. Only eight are currently in force. 4. 2008 and restated 2007 figures reflect value at cost (average cost of goods) rather than wholesale acquisition price (WAC). This is the first year we have valued our donations this way and believe it is a more accurate reflection of the true cost to GSK and is therefore more transparent. 2004 to 2006 figures remain at WAC. 5. This covers over 90 per cent of the animals housed in GSK-owned laboratories. 6. Includes contacts with line managers, compliance officers, our confidential Integrity Helplines or offsite
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
post office box (in the US). 7. 2004 data do not include inhalers made in Asia. 8. Climate change impact is calculated as CO 2 equivalent using the Greenhouse Gas Protocol developed by the World Resources Institute and the World Business Council for Sustainable Development. Each year we review the CO 2 factors and update the data for all years as appropriate. The greatest changes are generally in the updated factors for electricity. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Resources and downloads
Corporate Responsibility Report 2008 Resources and downloads Reporting 2008 Corporate Responsibility Report Commitment to transparency and access Corporate Responsibility Highlights 2008 (PDF 325Kb) GRI Index (PDF 103Kb) Global compact index (PDF 24Kb) Corporate responsibility data summary Environmental metrics Archive reports
Additional resources Access to medicines Briefing paper: Access to medicines (PDF 46Kb) Findings from stakeholder engagement sessions: GSK access to HIV medicines workshop (PDF 63Kb) GSK DDW workshop findings (PDF 68Kb) GSK MIC workshop findings (PDF 87Kb) Ethical conduct GSK Code of Conduct (PDF 89Kb) Employee Guide to Business Conduct (PDF 4.3Mb) GSK European Promotion of Medicines Code of Practice (PDF 450Kb) Human rights Human rights statement (PDF 30Kb) Public policy and patient advocacy Our Public policy position statements Details of relationships with patient groups Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Contribution to global health
Corporate Responsibility Report 2008 Contribution to global health How we respond to society¶s healthcare needs is the most important responsibility issue for GSK. It is also central to our commercial success. Ill health and disease continue to place a huge burden on society: from the AIDS epidemic in Africa and Asia to the health needs of an ageing population in the developed world and the huge global growth in chronic diseases such as diabetes. Emerging diseases such as pandemic flu pose potentially serious threats. Ill health is also expensive: it can increase healthcare costs and reduce economic productivity. Our business makes a significant contribution to society by bringing products to market that address the medical needs of patients around the world. We make a contribution in four key areas: Preventing disease: we are one of the world¶s largest producers of vaccines for diseases prevalent in developed and developing countries. We also prevent disease through our community investment, disease awareness work and our over-the counter products Treating ill health: many of our products treat diseases that place a high burden on society Investing in R&D: our pipeline includes new medicines and vaccines that are needed in developing and developed countries Contributing to scientific understanding: we participate in partnerships that advance scientific knowledge and lay the ground for future medical advances We believe that while our business makes a significant contribution to society, there is more we can do. We are looking at ways to accelerate research into neglected diseases by sharing research resources and findings with other organisations and expanding our partnerships with governments, NGOs and other pharmaceutical companies. We also want to partner with others to support delivery of healthcare services as well as medicines. Our products are only beneficial if they are accessible and affordable to healthcare payers and patients. Read about our efforts to increase access to our key products in developing and developed countries and how we support healthcare programmes through community investment. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Contribution to global health The cost of disease
Corporate Responsibility Report 2008 The cost of disease Ill health is expensive for the individual and for society. It is often a result of poverty but it is also an important cause of poverty. For patients it can mean loss of quality of life, loss of earnings and shortened life expectancy. It can place a great burden on families ± for instance the need to care for sick relatives can reduce attendance at school or work. For governments, employers and taxpayers it can mean increased healthcare costs and loss of workforce productivity. In Africa and parts of Asia, AIDS has had a serious effect on social and economic development, undermining progress towards the Millennium Development Goals and poverty reduction efforts. The World Bank estimates that the deaths of working age adults from HIV/AIDS may subtract one per cent a year from GDP economic growth in some sub-Saharan African countries. In South Africa HIV/AIDS may depress GDP by as much as 17 per cent over the next decade 1. Malaria is estimated to cost African nations at least $12 billion a year in lost economic output 2. The economic cost of TB-related deaths, including HIV co-infection, in subSaharan Africa is estimated at $519 billion between 2006 and 2015 3. Read about our research into diseases of the developing world and our efforts to help people in these countries access essential medicines and vaccines . According to the US government¶s Centers for Disease Control and Prevention (CDC), the costs of chronic disease in the US alone include 4: $174 billion a year in direct and indirect costs due to diabetes $81 billion in annual medical care costs for arthritis, and total costs including medical care and lost productivity of almost $128 billion $448 billion projected cost for 2008 for heart disease and stroke Read about how we are working in partnership in the US to combat chronic disease and the role of our vaccines in preventing disease. 1. 2. 3. 4.
www.who.int/trade/glossary/story051/en/index.html Rollback Malaria http://rbm.who.int/globaladvocacy/pr2007-11-29.html http://www.who.int/mediacentre/news/releases/2007/pr64/en/index.html www.cdc.gov/nccdphp/overview.htm
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Contribution to global health The role of vaccines
Corporate Responsibility Report 2008 The role of vaccines Vaccines play a major role in preventing and eliminating disease. Immunisation is acknowledged by the World Health Organization (WHO) as being µamong the most costeffective of health investments¶. Immunisation programmes make a substantial contribution to the aims of the United Nation¶s Millennium Development Goals for economic growth. It is estimated that at least three million deaths are prevented and 750,000 children are saved from disability due to vaccines every year 1. The number of deaths in Africa from measles fell 91 per cent between 2000 and 2006 due to better coverage of routine immunisation programmes and targeted campaigns to ensure that children had a second chance to be vaccinated 2. Despite this progress vaccines are under-used. It is estimated that the lives of over two million children could be saved each year if existing vaccines were made accessible to all who need them. This will require sustained financing and the development of innovative vaccination programmes. GSK is among the world¶s top vaccine providers. We have over 30 vaccines approved for marketing and over 20 in our R&D pipeline, one-third of which target diseases particularly prevalent in the developing world. GSK vaccines are included in immunisation campaigns in 169 countries worldwide. Over 1,600 scientists work in vaccine research at GSK and we believe our vaccine pipeline is the largest in the industry. We remain committed to researching and developing vaccines for all three WHO infectious disease priorities, tuberculosis, HIV and malaria. Together with the PATH Malaria Vaccine Initiative, in 2008 we demonstrated in phase ll trials significant protection against malaria for infants and young children with GSK ¶s RTS,S candidate vaccine. Read more about the malaria vaccine. In 2008 we supplied 1.1 billion vaccine doses. Of these, nearly 80 per cent were shipped for use in developing countries. Read about our tiered pricing system for vaccines. Our vaccine portfolio addresses the medical needs of developing and developed countries. Our portfolio covers most of the leading causes of childhood mortality, as defined by the World Health Organization. Our vaccine range includes products that protect against the following diseases: Cervical cancer
Pneumococcal disease
Chickenpox
Polio
Diphtheria
Rotavirus
Hepatitis A and B
Rubella
Measles
Seasonal influenza
Meningitis
Tetanus
Mumps
Typhoid
Pandemic influenza
Whooping cough (Pertussis)
1. Ehreth J. The Global Value of Vaccination. Vaccine (2003); 21 (7-8):596-600 2. Progress in Global Measles Control and Mortality Reduction, 2000-2006
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www.who.int/wer/2007/wer8248.pdf Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Contribution to global health Treating ill health
Corporate Responsibility Report 2008 Treating ill health We help to treat ill health by developing medicines and consumer healthcare products. We are also working with governments and employers in the US to find innovative ways to reduce the impact of chronic diseases. Our pharmaceutical products target diseases in the following areas: Anti-bacterials (antibiotics) and anti-malarials: infections, malaria Anti-virals: HIV/AIDS, herpes, hepatitis B, influenza Cardiovascular: heart failure, hypertension, deep vein thrombosis Central nervous system: migraine, epilepsy, anxiety, depression, Parkinson¶s disease, smoking cessation, anaesthesia, analgesia, anti-emetics Dermatology: eczema, dermatitis, psoriasis Metabolic: diabetes, osteoporosis, obesity Oncology: breast, cervical, lung and ovarian cancer, non-Hodgkins lymphoma, leukaemia, idiopathic thrombocytopaenic purpura Respiratory and immuno-inflammation: asthma and chronic obstructive pulmonary disease, rhinitis, postoperative ileus Urogenital: prostatic hypertrophy, over-active bladder We also make vaccines which prevent serious diseases. Our products help to improve health in a number of ways: Prolonging life ± our anti-retrovirals (ARVs) such as Combivir help patients to control the effects of HIV infection for many years. We sell our ARVs to the Least Developed Countries and to countries in subSaharan Africa at not-for-profit prices. Read more about our efforts to increase access to medicines Preventing complications ± many diseases such as diabetes are progressive if patients do not receive the right treatment they can suffer severe complications. For example, every day in the US diabetes is the cause of an estimated 225 lower limb amputations, up to 66 cases of blindness, and 117 people experiencing kidney failure. Avandia, our diabetes treatment, helps patients to control their symptoms, delays the progression of the disease and prevents complications. Avandia has now been used by more than seven million people worldwide. Improving quality of life ± many of our medicines such as those for asthma and diabetes help patients with chronic diseases live full and productive lives. GSK preventative treatments for asthma such as Seretide/Advair control the symptoms of asthma and prevent asthma attacks Curing infection ± we produce antibiotics that treat respiratory tract and other infections. We donate antibiotics to help relief efforts in disaster areas Paracetamol
Paracetamol is widely used as a low-cost medicine for treating adult and child pain and fever, and is listed as one of the World Health Organization¶s essential medicines. GSK produces ten billion tablets each year of our over-the-counter paracetomol product, Panadol, which
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
is available in more than 85 countries. This includes low- and middle-income countries, where we provide more affordable low-cost single-dose packs. Medical guidelines across the globe recommend paracetamol, the medicine in Panadol, as the first-line oral painkiller for chronic diseases such as osteoarthritis due to its efficacy, safety profile and costeffectiveness. It is also a first-choice treatment for other conditions such as headache, backache and children¶s fever. Paracetamol is the recommended treatment for the symptoms of dengue fever, a debilitating and lifethreatening disease that is transmitted by mosquitoes in tropical and sub-tropical regions. More than 2.5 billion people are at risk for infection ± two-fifths of the world¶s population ± in over 100 countries. Read about our efforts to increase awareness of dengue fever and correct treatment
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Contribution to global health Treating ill health Partnering to combat chronic disease
Corporate Responsibility Report 2008 Partnering to combat chronic diseases Healthcare costs in many countries are a concern for patients, healthcare payers and the pharmaceutical industry alike. The increase in prevalence of many chronic diseases such as asthma, diabetes and heart disease is a major contributing factor. We are working with governments and employers to find new ways to address the problem of chronic diseases while reducing healthcare costs. Our approach, known as the µtriple solution¶, has three focus areas: Prevention ± addressing the causes of chronic diseases, such as obesity and smoking, poor diet and lack of exercise Intervention ± properly managing chronic diseases to prevent complications, avoid hospitalisation costs and reduce time away from work Innovation ± developing new treatments for costly unmet medical needs such as Alzheimer¶s disease and stroke
Working with employers and communities In the US, healthcare is a major source of expenditure for the government, employers and consumers. In 2006, expenditures in the US on healthcare exceeded $2 trillion. Additionally, absence from work due to ill health can be a significant cost that often goes unrecognised. We work closely with state and local public health agencies and a large number of employers across the US to help them create health management programmes that remove barriers to healthcare access, reduce healthcare costs and improve health. Our organisation has worked with more than ten states, five municipalities and 200 employers to: Help address some of the diseases that put a great burden on healthcare budgets Encourage employers to provide preventative services to workers, for example, regular health screening to detect early signs of disease, awareness campaigns and initiatives to help employees adopt a healthy lifestyle. Develop disease management programmes which help employees control their symptoms and stick to their treatment regimens Initiate comprehensive wellness initiatives for obesity and smoking, for which we have leading products. Smoking is the leading cause of death and disease in the United States. The direct and indirect costs associated with being overweight and obese are estimated to exceed $100 billion per year in the US, approximately nine per cent of annual medical expenditures. We may advise employers to create new incentives for better health management, for example by reducing the co-pay element of prescription medicine charges. This can increase the total amount employers pay for pharmaceuticals in the short term. However, by improving patient medication adherence rates, it can prevent costly complications and time away from work in the longer term, and so help to lower overall healthcare costs.
The Diabetes Ten City Challenge
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Each day in the US, diabetes causes an estimated 225 lower limb amputations and up to 66 people to lose their sight. However, with the right treatment many of these complications can be prevented. The Diabetes Ten City Challenge, supported by GSK, is a partnership of city governments and private employers in ten cities, the American Pharmacist Association (APhA) Foundation and pharmacists. It helps employees with diabetes manage their condition through nutrition and medication and by adopting a healthy lifestyle. It aims to prevent serious side-effects and reduce associated healthcare costs. Key features include: Lower co-pays (the portion of prescription costs paid for by the patient), making medicines more affordable and making it more likely that patients will adhere to their prescribed treatment regimen Regular meetings between patients and pharmacists to discuss symptoms and identify any potential complications as early as possible Help for participants to set and achieve nutrition, exercise and weight loss goals, including printed materials and meetings with pharmacist coaches We share the Challenge¶s findings and resources with other employers outside the ten cities through a dedicated website. The programme is based on the APhA Foundation¶s Asheville Project, which helped reduce healthcare costs for participating employees by over 34 per cent and cut absenteeism by 50 per cent on average. A pilot project based on the Asheville Project has now been launched in Japan. Run by a team from Showa University, the pilot will involve 100 diabetes and asthma patients over a two-year period.
Community health centres In 2008 we donated over $130,000 to the St Cecilia¶s health centre in New Orleans¶ Ninth Ward, a part of the city which saw great devastation during Hurricane Katrina. The money has been used to fund the clinic ¶s Community Diabetes Outreach Program, which has helped it to exceed the US national average for the percentage of diabetics receiving regular tests and controlling their symptoms. Read more about our efforts to raise awareness and prevent disease.
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Home Responsibility Contribution to global health Disease awareness and prevention
Corporate Responsibility Report 2008 Disease awareness and prevention We are one of the world¶s largest producers of vaccines which play a vital role in preventing disease. We also develop over-the-counter products which help people to stop smoking, lose weight and maintain good oral health. We help to raise awareness among healthcare professionals and the public through our work with patient groups and our own disease awareness campaigns. These can take place to coincide with the launch of a new product or after it is on the market. This can have a positive impact on public health and create commercial benefits for GSK. Read more about our efforts to raise awareness and prevent disease.
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Home Responsibility Contribution to global health Disease awareness and prevention Raising awareness about disease
Corporate Responsibility Report 2008 Raising awareness about disease In 2008, we ran a range of disease awareness campaigns including: Pandemic flu The World Health Organization considers that the world is now closer to another flu pandemic than at any time since the last outbreak in 1968. In 2008, we held a workshop for journalists at the European Influenza Congress in Portugal to highlight the threat of pandemic flu. Journalists play an important role in raising government awareness of health issues and influencing health policy. During the workshop, participants spent two hours talking to independent experts, discussing key subjects such as what we can learn from past pandemics, the personal and economic impacts of an outbreak, the role of vaccines and what governments should do to prepare. Read about GSK¶s flu products and our efforts to help prepare for pandemic flu. Cervical cancer Our vaccine Cervarix helps to prevent infection from the cancer-causing types of the Human Papillomavirus (HPV) which most commonly lead to cervical cancer. A year before we launched Cervarix in Europe, research in this region showed that as few as two per cent of women knew of the link between HPV and cervical cancer. Since then, we have run disease awareness campaigns across many countries to highlight this link and educate people on the importance of screening to help prevent cervical cancer. The campaigns target healthcare professionals, media, policy makers and women through press articles, educational events for healthcare professionals and support for cervical cancer patient groups and their activities, such as the European Cervical Cancer Prevention Week. Rotavirus Rotarix is our vaccine against rotavirus, a leading cause of gastroenteritis infection. Rotavirus is associated with 25 million clinic visits, two million hospitalisations and more than 600,000 deaths worldwide among children under five every year 1. The launch of Rotarix in Mexico in 2004 and other Latin American countries was preceded by a widespread disease awareness campaign. To achieve this, GSK educated journalists about gastroenteritis infection caused by rotavirus, its causes, how to prevent it and how to detect its symptoms early. Rotavirus can quickly become fatal if a child becomes dehydrated and does not receive treatment. Our educational materials discuss vaccination and give guidance on prompt detection and treatment methods. Chronic diseases in the US Our US Healthy Communities programme, which has offered free health screenings in communities across the country, aims to educate people about chronic diseases and encourage them to take better control of their health. People who do not manage their chronic diseases may develop further complications, leading to greater health problems. In 2008 we announced the findings of nationwide health screenings of 65,000 people conducted as part of the programme. Although approximately 70 per cent of participants reported their health to be excellent, tests indicated that many were not in good health. For example, nearly half of the participants with type 2 diabetes showed poor glucose control. Nearly a third of the asthmatics we screened had poor control of their
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condition. Of the individuals with poorly controlled diabetes or asthma, over two-thirds had not visited a primary care physician in the past year 2. GSK partnered with the National Association of Chronic Disease Directors (NACDD) and WebMD, the health information site, to help people become more engaged in managing their health. As part of our µtriple solution¶ approach we encourage people to assess their risk of chronic diseases using a health check tool that provides advice about the five biggest health risks. Dengue fever Paracetamol is the recommended effective symptomatic treatment for dengue fever, a debilitating disease that is transmitted by mosquitoes in tropical and sub-tropical regions. Few people know the correct treatment for dengue fever, especially for children. People often use other fever-reducers such as aspirin which can exacerbate bleeding, a symptom of dengue fever. They also seek medical treatment late, which increases the risk of serious complications and death. Panadol, GSK¶s over-the-counter paracetamol brand, has a strong presence in regions where dengue fever is prevalent, notably Asia, Africa, the Middle East and Central and South America. GSK is in a position to take the lead in driving global awareness among healthcare professionals and the public against the dengue fever threat. We initiated and sponsored a dengue fever public awareness campaign in high-risk areas including the Caribbean and South-East Asia. We have worked in collaboration with organisations such as UNICEF and the Pan America Health Organization. We also engage with locally respected campaign ambassadors. The campaigns increase awareness through television, radio and PR activities as well as roadside banners and posters in hospitals, public health centres, pharmacies and drugstores. Local media have picked up on these activities, helping to raise awareness further. Health professionals are targeted to raise awareness and provide information that can help in diagnosis and treatment. Free Panadol samples are distributed in hospitals. A campaign run in Costa Rica during 2006 contributed to a 68 per cent reduction in dengue fever cases as reported by the Board of Health. In 2007, when the campaign did not run, the number of cases increased by 110 per cent. In 2008, GSK activated the campaign again in collaboration with The Board of Health. By the end of 2008, the 'I save lives' campaign contributed to a 72 per cent reduction in dengue cases. Similarly the Panadol campaign contributed to decreases in South-East Asian dengue cases especially in Indonesia where the dengue fever fatality rate dropped by 40 per cent in 2008 over the previous year. GSK is planning to continue this campaign in 2009 and beyond. 1. Parashar UD, et al Global illness and deaths caused by rotavirus disease in children. Emerg Infect Dis 2003; 9:565-72 2. Data on file
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Home Responsibility Contribution to global health Disease awareness and prevention Preventing disease
Corporate Responsibility Report 2008 Preventing disease Vaccines Vaccines make a significant contribution to health and are recognised as one of the most successful ways of preventing disease. Vaccines are second only to clean drinking water in reducing the impact of infectious diseases. GSK is one of the largest suppliers of vaccines and is the leading supplier of childhood vaccines to UNICEF. Vaccines are designed to eradicate or control disease and on an individual level to prevent disease or limit its severity. They can be highly cost effective and benefit both society and individuals. Vaccines have widespread endorsement from supranational organisations, including the WHO and the United Nations. The World Bank proposes that governments should make immunisation a priority for their healthcare investment. Immunisation programmes successfully eradicated smallpox worldwide and have made significant progress towards the elimination of polio. Even when global eradication is not possible, diseases can be reduced to very low levels if vaccination is maintained at high levels. For example, where Haemophilus influenzae type b vaccines are used, bacterial meningitis caused by this virus has been dramatically reduced. The majority of cervical cancers are now preventable with vaccination against the Human Papillomavirus (HPV) combined with cervical screening. GSK¶s vaccine against HPV, Cervarix, is now available in more than 90 high-, middle- and low-income countries around the world and we are committed to working to accelerate global access to theYDFFLQHCervarix was chosen as the vaccine for the National Immunisation Programme (NIP) in the UK, the largest Human Papillomavirus immunisation programme in the world to date. Since the NIP launch in September 2008, over 70 per cent of girls aged 12 to 13 have been vaccinated.
Consumer healthcare products Smoking cessation Smoking is a major public health problem, contributing to around five million premature deaths worldwide every year. Nicotine replacement therapies (NRT) can significantly increase a smoker¶s chance of stopping. GSK created the first over-the-counter NRT and we now market a range of nicotine replacement brands, including NiQuitin CQ/NicoDerm, Commit lozenge and Nicorette. They have helped more than 6.5 million people stop smoking since 1996. We estimate that around 20 per cent of smokers currently have access to NRT. We aim to increase this figure to more than 80 per cent by 2013 by launching our nicotine replacement brands in new markets. Poverty can be a major barrier to NRT purchase, especially in emerging markets. We provide smoking cessation education and counselling support to the Brazilian government as part of its efforts to help lowincome smokers who are trying to stop smoking. In 2008, we supported a petition submitted by the New York Commissioner of Health, asking the US Food and Drug Administration (FDA) to allow over-the-counter NRT products to be sold wherever cigarettes are sold and permit the sale of smaller packs with fewer doses that would have much lower prices. The FDA does not currently allow the sale of smaller, or one-day, affordable pack sizes. In the UK, we support the National Health Service¶s Stop Smoking Clinics. We provide the clinics with educational materials and run online and telephone support for smokers. We also help train NHS nurses and pharmacists as µstop smoking¶ advisers.
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Preventing obesity Obesity is a major cause of ill health and disease such as diabetes. alli, our over-the-counter weight-loss treatment, helps people lose weight when combined with a low-fat, reduced calorie diet. alli has been marketed in the US since 2007. In 2008 it received a positive opinion as a non-prescription product from the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use. In January 2009, the European Commission granted a non-prescription licence for the product. Since its launch in the US, six million starter packs of alli have been sold, helping millions of people to lose weight. Read a case study on how we ensure that alli is marketed responsibly. Oral healthcare It is important that people maintain good oral health, to prevent gum disease and tooth decay. Our oral healthcare products include toothpastes, mouth washes and denture cleaners. Our facility in Weybridge, UK, which makes global brands Aquafresh and Sensodyne, is the largest oral healthcare research centre in Europe. Employees from the facility regularly visit oral healthcare conferences and publish articles in journals, to promote the importance of using oral healthcare products such as ours. We co-sponsor the Innovation in Oral Care Awards with the International Association for Dental Research and we run an award scheme that recognises innovative research into preventing mouth infections and improving oral healthcare diagnostics. Community investment We also invest in community activities that focus on disease prevention. For example, we participate in the Global Alliance to Eliminate Lymphatic Filariasis, a leading cause of disability in tropical countries. Our PHASE hand-washing programme helps to prevent the spread of diarrhoea-related disease in children in developing countries. Back to top
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Home Responsibility Contribution to global health Investing in R&D
Corporate Responsibility Report 2008 Investing in R&D Despite advances in healthcare there are still many diseases for which there is no cure or for which treatments could be improved. Continued research and innovation is essential. Our investment in R&D into new medicines and vaccines is at the core of our business. In 2008, we spent 3.7 billion on R&D. Over 80 per cent of this expenditure was in pharmaceutical R&D with the remainder in vaccine and consumer healthcare R&D. We have nearly 150 prescription medicines and vaccines in clinical development, detailed in R&D of our Annual report. Our current late-stage pipeline includes products targeting diseases including many forms of cancer, infections, respiratory diseases, autoimmune disorders, metabolic and cardiovascular disease, psychiatric disorders and neurological diseases. In 2008, nine new products were approved for the first time. We made six first submissions for new products and product line extensions. For example, reflecting our strong focus on oncology, in December 2008 we filed in the US for a licence for pazopanib for the treatment of advanced renal cell carcinoma. Read about how we ensure high ethical standards in our R&D activity.
Expanding research capabilities and improving productivity One of our strategic priorities is to improve R&D productivity. During 2008 the R&D organisation was restructured to support this. The changes are described in the R&D section of our Annual report. In early 2008 we conducted a review, involving external experts, to identify the therapy areas where recent advances in science mean that there is more probability of finding new treatments. Based on the outcomes of the review, we refocused our early-stage research activities on the following areas: Biopharmaceuticals Immuno-inflammatory diseases Infectious diseases Metabolic pathways Neurosciences Oncology Ophthalmology Respiratory diseases R&D in China
Our Chinese R&D centre, opened in 2007, now has over 200 employees and in 2008 moved to state-ofthe-art facilities in Shanghai. The centre is investigating neurodegenerative disorders such as Alzheimer¶s disease, Parkinson¶s disease and multiple sclerosis. The centre is already progressing an early pipeline from target validation to candidate selection. We intend to develop the centre into our lead facility for global discovery and development activities in neurodegenerative disorders. The costs of conducting research in China can be lower than in other markets. However, lower costs are
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not the primary reason for opening the facility. China offers a huge pool of scientific talent ± our 2008 recruitment roadshow reached over 1,200 PhD graduates at ten top universities. Our R&D in China is conducted to GSK¶s global quality and ethical standards. All our R&D policies and monitoring procedures are global and apply to our operations in China.
Investing in new areas of science We are investing in technologies which are providing new opportunities for medical intervention, including: Stem cell technology We believe that stem cell science has great potential to aid the discovery of new medicines by improving screening, identification and development of new compounds. Using stem cells could also help us to develop medicines that are safer and more effective. Read about our collaboration with the Harvard Stem Cell Institute and our participation in the Stem Cells for Safer Medicines, a public-private partnership. External collaborations GSK does not have a monopoly on the best science and we are expanding our collaborations with external partners and business development activities to access innovations from outside our own organisation. We now have 35 external collaborations underway to complement our 35 internal Discovery Performance Units. Our immuno-inflammation Centre of Excellence for Drug Discovery announced a five-year research partnership with the Immune Disease Institute (IDI) in Boston, US. The partnership will combine IDI¶s worldclass immunological expertise with GSK¶s pharmaceutical capabilities. In 2008 we also signed our first agreement with the University of Cambridge to develop a compound with the potential for treating obesity and addictive disorders. The University will contribute know-how and expertise and will bear some of the financial risk for which they will be compensated if the programme is successful. GSK will provide operational support, access to our in-house clinical research and imaging facilities, and background preclinical data on the drug. Cambridge University will dedicate a team of academic experts in both neuroscience and metabolic disorders. Importantly, the agreement allows the academic scientists the freedom to publish the results from their work on µincubator¶ projects. In 2008 we acquired the pharmaceutical company Sirtris, which is the leader in research into sirtuins, a recently discovered class of enzymes believed to be involved in the ageing process. The combination of the specialist knowledge within Sirtris and GSK¶s development capabilities will provide the best possible chance of validating this new approach to diseases of metabolism and ageing. Read more about our investment in new technology in our Annual report. Back to top
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Home Responsibility Contribution to global health Contributing to scientific understanding
Corporate Responsibility Report 2008 Contributing to scientific understanding We fund basic medical research conducted outside GSK to increase understanding of the human body and the impact of disease. This is often the foundation for future advances in the diagnosis, treatment and prevention of disease. Often this research is conducted in partnership with others, using very new technologies. Examples from 2008 include:
Open innovation In December 2008, we announced a joint 4.1 million investment with the Wellcome Trust to generate µchemical probes¶ for 25 proteins involved in epigenetic signalling and to make them available to other researchers, without restriction. The partnership is part of our new commitment to promote openness in research collaborations. GSK and other pharmaceutical companies have traditionally kept research data confidential. This public-private partnership will be led by the Structural Genomics Consortium, and involve the National Institutes of Health¶s Chemical Genomics Centre in Washington, US, and the University of Oxford. The initiative could offer a new model for future interactions between academia and industry.
Collaborating to accelerate drug development In 2008 we renewed our support for the University of Dundee¶s Division of Signal Transduction Therapy (DSTT), in collaboration with the Medical Research Council and a consortium of other pharmaceutical companies. The aim of the DSTT is to accelerate the development of drugs that treat diseases such as cancer, diabetes and rheumatoid arthritis by targeting kinase and phosphatase enzymes. The collaboration will provide 10.8 million to the DSTT between 2008 and 2012. GSK has been working with the PATH Malaria Vaccine Initiative (MVI) since 2001 to develop the paediatric vaccine against malaria, RTS,S/AS. In December 2008 the partnership announced study results which showed that RTS,S/AS provides both infants and young children with significant protection against malaria. Pending national regulatory approvals, phase lll studies will start in seven countries across Africa in early 2009.
Patient safety A GSK team won a 2008 Wall Street Journal µTechnology Innovation Award¶ for Healthcare IT. The team developed a new software system that helps to screen novel drug candidates for potential safety issues. The system, known as Molecular Clinical Safety Intelligence (MCSI), helps GSK researchers to screen and prioritise novel drug candidates for potential adverse medical reactions at a much earlier stage, prior to clinical trials. The software enables direct translation of safety knowledge from human clinical experience to early-stage drug discovery for the first time. Read more about patient safety at GSK. Back to top
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Home Responsibility Contribution to global health Contributing to scientific understanding Academic collaborations
Corporate Responsibility Report 2008 Academic collaborations We invest in research capabilities at universities, fund leading-edge academic research projects and support science students. We have more academic collaborations than any other UK-based company, providing support of more than 24 million in 2008. Our support benefits academic institutions through increased funding, technology transfer and access to our research facilities and expertise. It contributes to better scientific understanding and capability in the countries where we operate. It benefits GSK by enabling us to tap into R&D expertise and activity outside the company and expands our potential recruitment pool of better trained scientists. Our support in 2008 included: The Academic Discovery Performance Unit, a new initiative to combine the best academic thinking with GSK¶s industry expertise A new agreement with the University of Cambridge to develop a novel agent with therapeutic potential for treating obesity and addictive disorders Alliances with leading universities to help accelerate drug discovery. For example, we have established research agreements with Trinity College Dublin and the University of Manchester A collaboration with agencies including the UK Engineering and Physical Sciences Research Council (EPSRC) and the Wellcome Trust to fund projects of mutual interest Training in GSK laboratories for undergraduates The intellectual property rights relating to academic collaborations are typically held by GSK but our partner institutions are free to use the outcome of the collaboration for their own future research. The university also receives a percentage of any financial returns derived from the new intellectual property.
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Home Responsibility Contribution to global health Pandemic flu: responding to the H1N1 outbreak
Corporate Responsibility Report 2008 Pandemic flu: responding to the H1N1 outbreak Updated 24 August 2009. We have been preparing for an influenza pandemic flu for many years, researching and developing prepandemic and pandemic vaccines, antivirals and face masks, as well as our existing antibiotics portfolio. Our preparations meant we were able to respond rapidly when a new influenza A (H1N1) strain emerged in Mexico in late April 2009. The World Health Organization¶s (WHO) decision on 11 June 2009 to move to Pandemic Alert Level 6 sent a particularly strong message to governments and other stakeholders involved in pandemic preparedness to ensure that adequate and robust plans are in place to respond to the new strain of H1N1 (known as ¶swine flu¶). A collaborative global response involving governments, international organisations and businesses is needed to reduce the impact of H1N1. GSK is committed to supporting governments and health authorities around the world to respond to this challenge.
GSK¶s contribution We offer three key products to combat pandemic flu: an H1N1 pandemic vaccine, Actiprotect a face mask and Relenza, an antiviral,. We have invested over US$2 billion to expand our capacity to manufacture these products. We believe that the global community should take steps to protect all populations, including those without resources to protect themselves. Read about our efforts to help facilitate access to Relenza and our pandemic flu vaccine in developing countries. Prevention and treatment ± our products Prevention Vaccines Immediately after we received the H1N1 ¶swine flu¶ virus strain in late May 2009 we began production of a vaccine that will help protect people against H1N1. We were unable to begin production before this because a vaccine needs to be based on the strain that it is acting against. We are now in full scale production at our manufacturing facilities in Canada and Germany and are working to make the vaccine available as quickly as possible. We expect to produce several hundred million doses of the H1N1 vaccine, to be delivered from September 2009 onwards. To date, GSK has received orders for 326 million doses. The vaccine is made up of an antigen (which stimulates an immune response to the virus) and an adjuvant (which helps to boost the immune response). The use of an adjuvant should help to increase the effectiveness of the vaccine and it should also mean that less antigen will be needed to produce the same amount of vaccine 1,QDGGLWLRQLQFOLQLFDOVWXGLHVZLWKWKH+1 (avian) influenza strain, the adjuvanted vaccine demonstrated the potential to provide protection even if the influenza strain drifts (changes slightly). 2,3 Delivery of the vaccine depends on gaining approval from the regulator. We are in discussion with authorities around the world to ensure the regulatory process proceeds asTXLFNO\DVSRVVLEOH,Q*6. received a European licence for a pandemic vaccine, based on a µmock-up¶ dossier containing data on H5N1 avian flu. We anticipate that this provisional licence will speed up registration of the H1N1 vaccine, because we can quickly supplement the data in the dossier with data on the actual H1N1 pandemic strain.
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We are currently in discussions with regulatory authorities to develop appropriate clinical development plans IRUWKHYDFFLQH The number of people studied in initial trials will be limited, because we need to provide governments with the vaccine as quickly as possible. Additional studies and ongoing monitoring will therefore be conducted once the vaccine is launched. GSK will rapidly share results of immunogenicity and postmarketing safety and effectiveness studies with the international community. Face masks GSK has developed Actiprotect, a face mask coated with an antiviral agent that provides a physical barrier that prevents the wearer from inhaling virus particles and kills the flu virus within one minute of contact. ActiprotectKDVQRWEHHQWHVWHGDJDLQVWWKHSDQGHPLF +1 VWUDLQ+RZHYHUWKHPDVNKDVEHHQ shown to inactivate all influenza virus strains that it was tested against including previous strains of H1N1, H5N1, H5N9, H2N2, H3N2, and an influenza B strain. We currently have limited manufacturing capacity for Actiprotect:HKDYHWKHUHIRUHLQYHVWHGLQLQFUHDVLQJ existing manufacturing capacity and are also seeking additional manufacturing capability through discussion ZLWKRWKHUFRPSDQLHV Treatment Relenza (zanamivir) is an antiviral that shortens the duration of flu, helping sufferers to feel better sooner. GSK has been working with governments to supply Relenza for use in a pandemic since 2003, when the global spread of avian flu (H5N1) began. Clinical tests show that H1N1 is also sensitive to Relenza. Following the outbreak of the H1N1 strain, we contacted governments around the world to establish demand for Relenza, to ensure equitable distribution of existing supplies and to put in place a series of measures to raise production levels. As a result, we now expect to increase our annual production capacity of Relenza to 190 million treatmentFRXUVHVE\WKHHQGRI 7KLVLVD more than threefold increase on our previous maximum annual capacity of 60 million treatment courses. Relenza is registered in over 100 countries and we currently have contracts in place to supply it to more than 60 governments. Supporting access to our pandemic flu products Many developing country governments lack the resources to protect their populations against H1N1, and they are concerned about their ability to mount an effective, rapid response. GSK is committed to facilitating access to Relenza and our pandemic flu vaccine in all countries. We strongly endorse the principles set out by the Gates Foundation to help guide global allocation of pandemic vaccines, and we support its message that the global community should take all steps necessary to protect all populations, including those without resources to protect themselves. We have committed to donate 50 million doses of our H1N1 vaccine and 2 million treatment courses of Relenza to the WHO for use in developing countries. To further ensure the vaccine is available to developing countries, and subject to the yield and existing contractual commitments, we have also allocated 20 per cent of H1N1 vaccine production capacity at our Canadian manufacturing site to developing countries. Ten per cent of our new, increased Relenza production capacity has also been allocated for developing countries. These commitments include the two donations to the WHO. We operate a tiered-pricing policy for both our pandemic vaccine and Relenza, based on World Bank classification of countries and GAVI eligibility for the vaccine. In line with our commitments set out in March to make our branded medicines more affordable to the world's poorest people Relenza will continue to be available at not-for-profit prices to Least Developed Countries. We remain committed to engaging in voluntary licence discussions with any companies willing to manufacture and supply zanamivir-containing products, the active ingredient in Relenza, for use in developing countries. For example, in 2006 we granted a voluntary licence to the Chinese manufacturer, Simcere, to manufacture and sell products containing zanamivir in China and a number of other countries, including all 50 of the world's Least Developed Countries.
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Ensuring business continuity We have taken steps to ensure that during a flu pandemic we can continue to supply essential pharmaceuticals and vaccines (against influenza and other serious diseases) to patients that need them. Read more about our business continuity plans. 1. Leroux-Roels et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370 (9587): 580±89. 2. Leroux-Roels I et al, Broad Clade 2 Cross-Reactive Immunity Induced by an Adjuvant systemed Clade 1 rH5N1 Pandemic Influenza Vaccine PLoS ONE 3(2): e 1665. doi:10.1371/jounal.pone.0001665 3. Baras et al. Cross-protection against lethal H5N1 challenge in ferrets with an adjuvanted pandemic influenza vaccine. PLoS ONE 2008; 3 (1): e1401. Back to top
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Home Responsibility Contribution to global health Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders Is your goal to cure disease or to find treatments for ongoing, chronic use? Ideally we want to cure disease. Our antibiotics help to treat diseases caused by bacterial infection and our anti-parasitic medicines help prevent and treat prevalent diseases such as lymphatic filariasis and malaria. Unfortunately, there is no known cure for most diseases. Our medicines help reduce symptoms and may need to be taken for long periods. These medicines are still valuable because they may enable the patient to have a more normal lifestyle, for example remaining in work or looking after their family. In many cases we are continuing research to find a cure. Ideally we want to prevent a disease from occurring in the first place, which is where vaccines have an important role. What factors do you consider when prioritising your R&D efforts? There are three main interrelated factors ± science, patient need and commercial potential. We assess scientific opportunities to determine how advances in scientific and disease understanding may lead to innovative new ways to treat or prevent disease. In 2008, we used the outcome of a systematic Therapy Area Review looking at the scientific understanding in 17 therapy areas to refocus our research effort. We continually evaluate the scientific information we obtain on our compounds to help us predict whether they can be developed into effective and well-tolerated medicines. Assessing patient need is fundamental to R&D at GSK. This ranges from looking for medicines that will treat diseases for which there are no current effective treatments, to the development of medicines that improve on existing treatments in terms of safety, efficacy or ease of use. Our assessment of the commercial potential of possible new treatments includes: how our product would be differentiated from those of our competitors; the size of the potential market for any new treatment; and the range of conditions it may be suitable for treating. The better able we are to meet patient needs, the more likely it is that a product will be commercially successful. However, it is not always possible to achieve a return on investment, for example when developing treatments for diseases that are prevalent in the developing world. In some cases, where commercial potential is limited but patient need is high, we may seek ways to share the costs and risks associated with drug development. Are you researching drugs to treat serious diseases? Our pipeline and product range includes products against most of the major causes of mortality and morbidity (disease). Our product launches in 2008 included Promacta for treatment of idiopathic thrombocytopenic purpura and Volibris for pulmonary arterial hypertension. Our top-selling products in 2008 treat asthma and chronic obstructive pulmonary disease, epilepsy and bipolar disorder, diabetes, herpes and migraine. Our vaccines portfolio includes vaccines to prevent influenza, hepatitis, rotavirus and Human Papillomavirus infection which can cause cervical cancer. We also make vaccines to prevent many childhood illnesses such as measles and rubella. How do you measure R&D productivity? The ultimate measure of our productivity is the delivery of new medicines to meet patients¶ needs. In 2008,
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GSK launched three products based on new chemical or biological entities, six new vaccines and a number of product line extensions that benefit patients. Our target is to sustain a late-stage pipeline of around 30 key assets. However, given that research and development can take longer than ten years, we measure productivity in a number of ways during the R&D process, including: The number of compounds in our pipeline, and the emerging risks and benefits of these compounds Our success at progressing compounds in our pipeline through clinical trial phases l, ll and lll and to market registration The speed of progress through our pipeline, which is an indication of the efficiency of our R&D processes Is it true that research productivity is falling in large pharmaceutical companies? How is GSK managing this? Investment in pharmaceutical R&D has risen while the number of new medicines gaining regulatory approval has remained relatively constant or decreased. We believe there are many reasons for this, including: An increasing focus on R&D into chronic degenerative diseases such as Alzheimer¶s which are scientifically challenging, require longer clinical trials and have increased failure rates Significant investment by industry in new technologies which will help deliver innovative medicines in the longer term, for example systems biology tools, genome-wide association scans, new in vitro and in vivo models and sophisticated imaging equipment More extensive requirements from regulators and healthcare payers, including the need to conduct larger clinical studies to evaluate the long-term outcome of treatment with a medicine, as well as higher hurdles for approval The effectiveness of existing treatments for some conditions, so that demonstrating improved safety or efficacy of a new treatment is increasingly difficult Our approach is to focus on meeting patients¶ needs and increasing the effectiveness and efficiency of R&D. For example, in 2008 we established 35 Discovery Performance Units (DPU) within our established Centres of Excellence for Drug Discovery. DPUs are small groups of scientists focused on a specific disease or molecular pathway, and structured to be as efficient as possible. These organisations combine the entrepreneurial approach of a small company with the resources and reach of a larger organisation. Back to top
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Home Responsibility Access to medicines
Corporate Responsibility Report 2008 Access to medicines Access to healthcare is one of the world¶s most pressing social challenges. Every year millions of people in developing countries die from curable infectious diseases because they do not have access to basic healthcare services, including essential medicines. Millions more are unnecessarily exposed to the threat of ill health through inadequate or ineffective disease prevention strategies. There are a number of complex factors that prevent access to medicines. There is often a limited prospect of a commercial return on R&D for neglected diseases; there is no unified registration system for medicines which makes the registration process costly, complex and time consuming; in many developing countries there is no distribution network for medicines and no healthcare infrastructure to treat patients and prescribe medicines. However, these problems must not be an excuse for inaction; rather they should indicate where action is most needed. Over the last decade, the pharmaceutical industry has helped to address healthcare challenges in the developing world by researching new medicines and making them more available and affordable. Despite this progress, the scale of the healthcare crisis means that the industry must now take a more proactive approach. We have identified four key areas through which we will strengthen our approach: 1. Being more flexible on intellectual property 2. Being more flexible on pricing 3. Recognising that we achieve more in partnerships than we do alone 4. Looking at how we can move from being a supplier of medicines to being a partner in delivering solutions Read more about our plans in these areas. Abbas Hussain, President of Emerging Markets at GSK, leads our access efforts. These are also reviewed by the Corporate Executive Team, GSK¶s most senior team, and by the Corporate Responsibility Committee of the Board. Increasing access to medicines is important to our business for ethical, reputational and commercial reasons because: It is morally the right thing to do and is valued by our shareholders, employees and other stakeholders. It is aligned to our corporate mission and contributes to GSK¶s reputation and ability to attract and retain talented employees Our business objective is to increase the proportion of the world¶s population that has access to our medicines ± currently around 20 per cent. The successful pharmaceutical companies of the future will serve a bigger proportion of the world¶s population Our business relies on the intellectual property (IP) rights system which encourages medical innovation and progress. By taking measures to counter claims that IP is a major barrier to access, and by looking for ways to improve availability and affordability, we can help to increase access while maintaining support for intellectual property rights in our key business areas The access problem is not confined to the developing world. For example, in the US many people suffer unnecessary ill health because they do not have healthcare insurance.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Our community investment programmes provide an additional resource for addressing healthcare challenges around the world. They support under-served communities through funding, education, practical support and donations. We are always looking to refine and improve our contribution to improving access to medicines and in 2009 our CEO Andrew Witty announced a number of new approaches that we will be pursuing. ³I believe the pharmaceutical industry has a huge role to play. But we need to take much more of a leadership role. Historically we have always reacted to problems. In the future I want us to be proactive, genuinely finding new ways to increase research, increase access and eradicate disease. ´ Andrew Witty, CEO (Speech at Carter Center, Atlanta, 4 December 2008) Highlights
Announced new approaches to increase flexibility in pricing in Least Developed Countries and intellectual property relating to neglected diseases Identified as the industry leader in the first Access to Medicines Index Successful results reported from phase ll clinical trials of RTS,S, our malaria vaccine candidate for African children Entered into new R&D partnership with the Drugs for Neglected Diseases initiative Not-for-profit prices for anti-retrovirals reduced Positive opinion received from the European Medicines Agency for our pneumococcal vaccine 349 million anti-retroviral tablets supplied to developing countries including 279 million tablets supplied by generic manufacturers licensed by GSK 1.1 billion vaccines shipped, of which almost 80 per cent went to the developing world. Restructured our commercial operations to reflect the needs of patients and business opportunities in emerging markets Entered into new partnerships and acquisitions to develop a more relevant product portfolio
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Home Responsibility Access to medicines Our approach and contribution
Corporate Responsibility Report 2008 Our approach and contribution GSK is committed to playing our full part in addressing healthcare challenges around the world. Our core business activity, developing and launching new medicines and vaccines, makes a significant contribution. We recognise that the scale of these challenges requires a coordinated approach and we are looking to expand research partnerships with governments, NGOs and other companies. While support for intellectual property rights is essential to encourage innovation, we want to find ways that we can use our intellectual property flexibly to speed up the development of medicines for neglected diseases, without compromising the sustainability of our business. There is only so much difference that our activities on R&D, pricing and working in partnerships can make while significant barriers to access remain in developing countries. Key among these barriers is the lack of healthcare infrastructure - both physical and human. Although we are not a health service provider, we want to work with others to deliver healthcare, which can include investing in infrastructure. We will seek new opportunities in this area and are already making a contribution in strengthening infrastructure. For example in 2008 we donated equipment for a state-of±the-art laboratory at the Lagos State University College of Medicine. Professor Clement Adebamowo, Chairman of the National Health Research Ethics Committee of Nigeria, said that the new laboratory would help Nigeria regain lost ground on health research and reclaim its position as a reputable partner in education and health research. Playing our part to address global healthcare challenges, both individually and through partnership, is not only the right thing to do, it also makes good business sense. We work to address global healthcare challenges through action in four areas: Improving affordability by preferential pricing of our medicines and tiered pricing of our vaccines in the world¶s poorest countries, exploring new business models in middle-income countries, and providing discount cards in developed countries Investing in research and development that targets diseases affecting the developing world Working in partnerships to research new medicines and to help deliver healthcare services Undertaking community investment activities and partnerships that foster effective healthcare We recognise that the developing world in particular poses many healthcare challenges. This requires a long-term commitment. Fundamental to our approach is the need to ensure that our contribution is sustainable and is built into the way we do business. We have a duty to try to ensure our products are used in a clinically appropriate way in all countries where they are available. This is particularly important in the case of communicable diseases, where inappropriate use of products can speed the development of resistance to treatment. Our activities are undertaken in partnership with organisations that have relevant specialist knowledge, such as governments, international agencies, charities, other private sector organisations and academic institutions. GSK was ranked top in the first Access to Medicines Index, published in June 2008. The Index rates companies on their performance according to eight criteria: management, influence, research and development, patenting, capacity, pricing, drug donations and philanthropy. While we retain some concerns with the methodology used in this report, we are pleased that our multi-faceted efforts to make our medicines
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more available have been recognised by the Index. This is testament to our innovative and sustainable approach, and the many GSK employees who contribute to our efforts to help address healthcare challenges in the developing world.
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Home Responsibility Access to medicines The role of others
Corporate Responsibility Report 2008 The role of others Improving access to healthcare in developing countries is a complex challenge. We believe that only a holistic approach embracing prevention and treatment as well as fundamentally strengthening health systems will work. This will require all stakeholders, including the pharmaceutical industry, to work together to increase the resources dedicated to improving healthcare systems. Pharmaceutical companies, including GSK, must make their medicines as affordable as possible to people in the world¶s poorest countries, in a sustainable manner. We must invest in research into diseases of the developing world because new prevention tools and treatments are urgently needed. Companies must look for ways to use intellectual property rights flexibly to maximise R&D resources for neglected diseases. Rather than just being suppliers of medicines, we must also support governments in their efforts to strengthen health systems, developing innovative ways to deliver our medicines to the people who need them most. Wealthy nations must give more. New funding is coming from the Global Fund to Fight AIDS, TB and Malaria, the Bill & Melinda Gates Foundation, PEPFAR (The US President¶s Emergency Plan for Aids Relief), UNITAID and others, but funds are still inadequate and need to be more predictable and sustainable. Resources are needed to fund research, strengthen health systems, purchase medicines, support disease prevention and discourage the migration of trained healthcare workers from developing countries. The current global financial crisis must not divert resources away from assisting developing countries. Developing countries themselves must show genuine political commitment to prioritising healthcare in national budgets, addressing stigma and improving affordability by removing import tariffs on medicines. As part of this approach, middle-income countries must accept their responsibilities and not seek the lowest prices that are offered to the world¶s poorest countries. All countries should provide an environment that encourages innovation through support for intellectual property (IP) rights, and should avoid measures such as widespread compulsory licensing which may negatively impact on investment in R&D and innovation. A more supportive environment for IP generally will encourage companies to be more flexible with their IP and less defensive. Countries should also address the risk of product diversion from patients in poor countries to those in wealthier ones. We lobby governments and policy makers to advocate a sustainable approach to improving healthcare in the developing world. Such an approach must support innovation, which is critical to improving access in the longer term. In 2008 our work in this area included: Urging the G8 to continue making healthcare in the developing world a major agenda item Supporting the development of a pilot Advance Market Commitment for a pneumococcal vaccine Engaging in the work of the WHO¶s Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property Working with the UK government on global health issues and in the development of the Department for International Development¶s (DFID¶s) Medicines Transparency Alliance (MeTA) and the review of its Good Practice Framework for pharmaceutical companies Playing a leading role in Pharma Futures 3, an industry dialogue exploring the links between sustainable pharmaceutical business models and improved health outcomes in middle-income markets, including
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China, India and Brazil Discussing IP, innovation and funding with NGOs, foundations and other stakeholders Attending WHO Executive Board Meetings and the World Health Assembly Meeting with the UN Secretary General, Ban Ki Moon, to discuss priorities in addressing HIV/AIDS Contributing to the design of an Affordable Medicines Facility for Malaria Playing a leading role in major global health initiatives. For example GSK sits on the Boards of the GAVI Alliance and Roll Back Malaria Participating in Board meetings of the Global Fund to Fight AIDS, TB and Malaria and supporting the development of its Quality Assurance standards Contributing to development of UN Human Rights Guidelines for Pharmaceutical Companies in relation to access to medicines Engaging in the negotiations on the WTO Doha Round to seek sustainable pro-innovation outcomes Addressing HIV/AIDS in the EU and neighbouring countries through the European Commission¶s Bremen Process Engaging with the Intergovernmental Meeting on Pandemic Influenza Preparedness Contributed to a report being prepared by Paul Hunt, the UN Special Rapporteur on the Right to Health. The report is on GSK¶s approach to access to medicines. A number of senior executives, including our former CEO, Dr JP Garnier, and our Chairman Sir Christopher Gent, were interviewed. We expect the report to be published in the first half of 2009. Read more about our malaria advocacy.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Access to medicines Developing countries
Corporate Responsibility Report 2008 Developing countries Poverty is the underlying cause of the healthcare crisis in many parts of the developing world. In the world¶s poorest countries, millions of people do not have reliable access to food and clean water, never mind adequate healthcare services. The healthcare crisis in the developing world is complex, and only a holistic approach will work to improve the situation. This must involve a comprehensive programme of prevention, health education, screening diagnosis and treatment, community care and support. Increasing access to medicines also plays a vital part. In all of these areas, GSK seeks opportunities to make a contribution. Significant additional funding from national and international sources must be mobilised to really make a difference. The WHO recommends a minimum spend on health of 17 per person per year to provide the most basic health services. Yet the average spend in sub-Saharan Africa is just 5, according to the UK¶s Department for International Development. The African Region of the WHO suffers more than 24 per cent of the global burden of disease, but has only three per cent of the world¶s health workers. The pharmaceutical industry must look to form partnerships to help deliver healthcare services. Political will is needed to aid development and build healthcare infrastructure. GSK can make an important contribution by: Researching new treatments and vaccines for diseases affecting developing countries Registering our products in the countries where they are needed most Offering preferential pricing arrangements for medicines and tiered pricing for vaccines that are needed most Seeking innovative partnerships to help improve healthcare in the developing world Granting voluntary licences to allow companies to manufacture our medicines Investing in projects to support healthcare delivery in under-served communities Diseases disproportionately affecting developing countries
Malaria kills over a million people a year, mostly children under five years old Around two billion people worldwide are infected with TB and over 1.5 million people die from the disease each year. No new treatments for TB have been developed in the last 40 years UNAIDS estimates that HIV/AIDS-related illnesses killed two million people in 2007 and that over 33 million people worldwide are living with HIV Worldwide a woman dies of cervical cancer every two minutes; 85 per cent of these are in the developing world Rotavirus infection causes 600,000 deaths each year, mostly in children under two years of age. Up to 85 per cent of these deaths occur in low-income countries
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Home Responsibility Access to medicine Developing countries Research and development
Corporate Responsibility Report 2008 Research and development For some diseases affecting developing countries there are no effective treatments. In other cases, treatments exist but have become less effective due to drug resistance. Sometimes treatments are not suitable, for example, because they are difficult to administer in areas with poor healthcare infrastructure or they are too expensive. As a research-based company, we aim to make a major contribution to health in developing countries by researching and developing affordable new vaccines and treatments for infectious diseases. We are currently conducting R&D into 12 diseases of particular relevance to the developing world: bacterial meningitis, chlamydia, dengue fever, hepatitis E, HIV/AIDS, leishmaniasis, malaria, pandemic flu, pneumococcal disease, Chagas disease, human African trypanosomiasis and TB. For more information on our R&D pipeline see our Annual Report. Biomedical R&D is a costly, risky and time consuming activity. To develop one successful medicine or vaccine it can typically take 10 to 12 years and, on average, including the costs of failures, costs around $1.2 billion 1. For every 5,000 to 10,000 compounds tested, an estimated five reach clinical trials and only one reaches the market 2. What¶s different about R&D for medicines for the developing world?
GSK scientists working on treatment projects for diseases of the developing world (DDW) make access to medicines a priority right from the start of the R&D process. When researching a new DDW treatment we emphasise factors such as: Heat and humidity resistance ± the product must be able to survive in a hot climate where there may not be refrigeration facilities Ease of use ± it must be easy to use in settings where there are limited healthcare facilities. For example, once-a-day tablets that can be taken at home are preferable to an injectable medicine that must be administered in a hospital or clinic Affordability ± price is one of the most important factors. We look for molecules and formulations that are straightforward to manufacture and therefore inexpensive to produce For diseases which disproportionately affect the developing world, but where a market exists in developed countries such as HIV/AIDS, we can still pursue this business model. We will accept all the R&D costs and risks involved on the expectation that there will be a market in wealthy countries that can subsidise poorer ones. For other diseases of the developing world where no such market exists we have to pursue new ways of working. One solution is the public-private partnership (PPP) model, in which businesses and the public sector work together. The model enables collaborators to achieve more together than they would do alone. We are also exploring ways to share knowledge with other organisations to help facilitate and speed up the discovery and development of new medicines. By being more flexible with our intellectual property, we aim to encourage other pharmaceutical companies to follow suit. We believe GSK is currently the only company researching new vaccines and treatments for all three of the WHO¶s priority infectious diseases, malaria, TB and HIV/AIDS. We also have an extensive portfolio of R&D projects for diseases of the developing world. We are an industry leader in research into HIV/AIDS treatment, and are currently evaluating multiple second-generation integrase inhibitors in clinical development.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
We also look for new treatments for other neglected diseases, typically in collaboration with external partners. For example, we engage in ongoing R&D programmes in leishmaniasis, Chagas disease and human African trypanosomiasis (African sleeping sickness). We have created a dedicated group to focus on diseases of the developing world which is fully integrated into our pharmaceutical R&D organisation. This group prioritises projects based on their socio -economic and public health benefit rather than on commercial returns. In addition to scientists based in the UK and US, this includes a drug discovery centre at our Tres Cantos R&D site in Spain where over 100 scientists focus primarily on malaria and TB. Half of these scientists are funded by PPPs, the Medicines for Malaria Venture and TB Alliance. A group focused on developing world diseases is also active in our vaccines organisation in Belgium. We are looking at ways to expand the Tres Cantos site into a global centre of excellence by encouraging investment and collaboration from governments, NGOs and other companies. Our overriding objective is to ensure that GSK makes the best possible contribution to improving the health of those affected by neglected diseases of the developing world. This will be achieved by pursuing an approach that will lead to the most extensive, effective and sustainable pipeline for diseases of the developing world (DDW) by: Increasing partnerships with external DDW communities to cover more neglected diseases, more diverse expertise, research tools, novel targets, developable drug candidates and worldwide talent pool including strong links with the best academic groups Spreading the DDW remits and learning in developing countries and emerging markets by sharing training activities and science forums for researchers or upcoming scientists from these countries, while avoiding any brain drain downsides Strengthening current R&D partnerships with organisations such as with Medicines for Malaria Venture (MMV), TB Alliance, Drugs for Neglected Diseases Initiative (DNDi), International AIDS Vaccine Initiative (IAVI), PATH, Malaria Vaccine Initiative (MVI) and the Aeras Global TB Vaccine Foundation, as well as seeking new partnerships Read our positions statements on: Clinical trials in the developing world Paediatric medicines Briefing: The treatment of children living with HIV in developing countries 1. Tufts Center for the Study of Drug Development 2. Pharmaceutical Industry Profile 2008, Washington DC, PhRMA March 2008
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Home Responsibility Access to medicine Developing countries Research and development Malaria
Corporate Responsibility Report 2008
Malaria We have been working on a malaria vaccine for over 20 years and have invested more than $300 million of our own resources to date. We are currently developing a candidate malaria vaccine, RTS,S, in partnership with the PATH Malaria Vaccine Initiative (MVI), which has contributed more than $100 million. In 2008, results of two separate phase ll trials confirmed the findings of earlier studies that the candidate vaccine provides infants and young children, the most vulnerable groups, with significant protection against malaria. In children aged five to 17 months, the RTS,S/AS01 vaccine reduced the risk of clinical episodes of malaria by 53 per cent over an eight-month period 1. In the other trial, among infants under 12 months who received three doses of a modified RTS,S/AS02 vaccine, the risk of first infection from malaria was reduced by 65 per cent over a six- month period 2. Trials also showed that the RTS,S/AS02 vaccine does not interfere with the efficacy of other vaccines administered through existing African national immunisation programmes. This means that in countries where malaria is most prevalent, the vaccine could be delivered through the current immunisation schedule for infants, called the WHO Expanded Program on Immunization (EPI). Christian Loucq, MVI Director, commented on the significance of the trial results by saying, ³we are closer than ever before to developing a malaria vaccine for children in Africa´. In 2009 we will commence large-scale phase lll vaccine efficacy trials in seven African countries across 11 sites. If these trials confirm the safety and efficacy of the candidate vaccine, it could be filed for registration in 2011 and introduced as early as 2012 for children five to 17 months of age. It will take longer to establish efficacy in infants of EPI age (six weeks old) due to the complexity of enrolment for trials, so the earliest the vaccine could be fully available following approval for use in infants is 2014. Read more in the malaria vaccine case study. Update August 2009
The Phase III trial of the RTS,S malaria vaccine candidate started in Bagamoyo, Tanzania, in May 2009. Our work on malaria treatments includes: Tafenoquine, a potential new treatment for the radical cure of P. vivax malaria being developed in partnership with the Medicines for Malaria Venture (MMV). As well as causing an acute infection of red blood cells, P. vivax causes a dormant infection of liver cells from which the parasites can reactivate, resulting in a reappearance of parasites in the blood and a recurrence of malaria. A radical cure implies the complete elimination of malaria parasites from the body, including the dormant liver stages. Tafenoquine offers the potential for a one to two day treatment course and could replace primaquine as the standard of care for a P. vivax radical cure. An initial study, commencing in 2009, will focus on further understanding the safety of tafenoquine in subjects with inherited glucose -6-phosphate dehydrogenase (G6PD) deficiency. ³Tafenoquine is a novel inclusion for MMV¶s portfolio. Given its activity against the liver stages of malaria, or hypnozoites, it is an essential part of the fight against P. vivax infections. As the malaria elimination agenda moves forwards we need an increasing array of tools against the parasite,´ said Dr Timothy Wells, Chief
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Scientific Officer at the Medicines for Malaria Venture. "MMV and GSK have worked successfully on a number of malaria projects in the past. Together, we hope to develop a radical cure for P. vivax malaria´. Pyridones, a new class of compounds with the potential to be highly effective against drug -sensitive and drug-resistant strains of both P. falciparum and P. vivax malaria. Pyridone GSK932121 is being developed in partnership with MMV. We entered µfirst time in human¶ clinical trials early in 2009. A back-up programme included in the GSK/MMV agreement is now well advanced and a candidate for development is expected by mid-2009 Isoquine, a new 4-aminoquinoline compound. The µfirst time in human¶ clinical trial was completed in 2008. Based on advice from the MMV Expert Scientific Advisory Committee and following discussions with all three partners (GSK, University of Liverpool and MMV), the isoquine project has been terminated until such time as evidence can be provided to demonstrate that adequate therapeutic blood exposures can be achieved after an acceptable oral dosage 1. Bejon P, Lusingu J, Olotu A, et al. Efficacy of RTS,S/AS01E : clinical malaria in 5 to 17 month old children. N Engl J Med 2008;359: 2. Abdulla S, Oberholzer R, Juma O, et al. Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med 2008;359:2533-44. 3. GSK press release issued 29 February 2008
Dacart and Lapdap
As reported in the 2007 corporate responsibility report, early in 2008 GSK and Medicines for Malaria Venture (MMV) received data from two phase lll clinical trials assessing use of the artemisinin-based combination therapy Dacart we were developing together. One trial was primarily designed to establish the efficacy of Dacart versus Coartem, currently the firstline anti-malarial therapy in many endemic countries. The second trial was designed to establish the efficacy of Dacart versus Lapdap (chlorproguanil and dapsone), another anti-malarial product GSK had developed in a partnership including the World Health Organization and the UK¶s Department for International Development3. A key safety finding from these trials was that patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency were found to be more at risk of anaemia after taking either Dacart or Lapdap. Consequently, given the haematological profile of Dacart, and the fact that 10-25 per cent of the population in subSaharan Africa is G6PD deficient, GSK and MMV decided to terminate the further development of Dacart. For the same reasons, GSK also decided to withdraw Lapdap from the market. This disappointment highlights the highly risky and complex nature of pharmaceutical research and development. However, GSK remains committed to working with partners such as MMV to seek solutions for patients suffering from this devastating disease.
Home Responsibility Access to medicine Developing countries Research and development Tuberculosis
Corporate Responsibility Report 2008
Tuberculosis Our tuberculosis medicines research is conducted in partnership with the Global Alliance for TB Drug Development (TB Alliance). In January 2008 we announced a renewal, for a further three years, of our joint research programme with the TB Alliance.
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Speaking at the time of the announcement, Dr Mel Spigelman, TB Alliance Director of Research and Development, said: ´We are encouraged by the success of our pioneering work with GSK, which has nearly doubled the number of TB drug discovery projects in our pipeline. This collaboration is advancing the TB Alliance¶s mission to develop revolutionary, faster and better TB treatment regimens by exploring new ways to attack the disease´. Our lead TB project on mycobacterium gyrase inhibitors expects to select a candidate for development by mid 2009. Other TB partnership projects under way include: Research into biomarkers. Currently, the effectiveness of a new TB drug cannot be determined until 18-24 months after completion of treatment. Biomarkers that enable us to predict at an early stage how patients are responding could significantly speed up TB research Mtb72f is our TB candidate vaccine being developed with the Aeras Global TB Vaccine Foundation. Early results are positive, suggesting that the vaccine is safe and produces a strong immune reaction in adults in TB endemic regions. Trials are now planned for infants in TB endemic regions.
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Home Responsibility Access to medicine Developing countries Research and development HIV/AIDS
Corporate Responsibility Report 2008 HIV/AIDS We have been involved in AIDS vaccine research for over two decades. GSK is also committed to the development of new molecules that target unmet medical needs in HIV, and there is a pressing need for a variety of new anti-HIV drugs with novel mechanisms of action.
Vaccines We are now pursuing three separate vaccine strategies. A successful AIDS vaccine might combine several of these approaches: Recombinant measles vector ± the measles vaccine is one of the most powerful, providing life-long protection against the disease. We are working with the Pasteur Institute in Paris to develop an AIDS vaccine by fusing genes from the HIV virus onto a measles vaccine F4co, our own candidate vaccine, will advance into phase l/ll trials in HIV-infected subjects in 2009 An extramural collaborative discovery R&D programme that aims to identify an HIV envelope-based protein vaccine capable of producing broadly neutralising antibodies against HIV infection In addition, we continue to collaborate with the International AIDS Vaccine Initiative (IAVI) and during 2009 we will be evaluating modifications to our joint programme.
Treatments GSK is committed to the development of new molecules that target unmet medical needs in HIV, and there is a pressing need for a variety of new anti-HIV drugs with novel mechanisms of action. Integrase inhibitors represent an important new class of compounds for the treatment of HIV, and it is increasingly clear that second-generation integrase inhibitors will be needed to address issues such as drug resistance and dosing complexity. We currently have a number of second-generation integrase inhibitors in the early stages of clinical development. In February 2009 we announced a licence agreement with Idenix Pharmaceuticals Inc. granting GSK exclusive worldwide rights to IDX899. This is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) in phase ll clinical development being developed by Idenix for the treatment of HIV/AIDS. New NNRTIs are needed to address the increasing prevalence of viral resistance and side effects associated with this drug class. To date, IDX899 has demonstrated high potency with low milligram doses, a high barrier to drug resistance, favourable risk/benefit profile and the convenience of once-a-day administration. In 2007, there were 2.5 million children living with HIV worldwide ± nearly 90 per cent of them in sub-Saharan Africa. We are committed to improving the treatment for children living with HIV/AIDS by developing products designed for use in children and developing scored tablets that simplify treatment. Scored tablets enable our anti-retrovirals (ARVs) to be broken into two smaller doses which simplifies treatment for children. WHO and UNICEF have stated that access to a tablet form of ARVs could improve treatment options for children able to swallow tablets. Tablets are often easier to store and distribute, and also less complicated to administer than the liquid formulations currently available ± particularly when two or three medicines are combined in one pill. In 2007 we gained approval from the European Commission for new scored tablets for Epivir, Combivir and Ziagen. This will enable children above 14 kilograms weight to benefit from a solid dosage form. In 2008 we received approvals for Epivir and Ziagen scored tablets from the US Food and Drug Administration and in
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February 2009 the FDA approved the scored version of Combivir. The new tablets can make treatment easier for children. For example, a child weighing 20 kilograms can now take half a tablet of Combivir in the morning and the second half in the evening in combination with another ARV, instead of requiring 8 ml of Epivir solution twice a day plus 12 ml of Retrovir solution three times daily. We have also committed to support four paediatric clinical studies in resource-poor countries to determine the best ways to expand access to HIV/AIDS treatment. Through our International HIV Collaborative Research Trials (CRT) Programme for resource-poor settings, we are supporting clinical trials that are sponsored by external organisations such as the WHO, the UK¶s Medical Research Council and the US National Institutes of Health (NIH). At the end of 2008, 20 trials were under way and a further three planned involving approximately 32,500 patients. Nineteen of the trials are conducted at sites in Africa. These CRTs focus predominantly on public health-related issues in the developing world, such as prevention of mother-to-child HIV transmission, paediatric treatments strategies and HIV-TB co-infection. GSK donates study anti-retrovirals and/or financial support, and also provides scientific input. Countries in which HIV CRT studies are being conducted include: African countries
Asia and Latin America countries
South Africa Uganda Zimbabwe Kenya Botswana Zambia Tanzania Malawi Ethiopia Mali Nigeria
India Thailand Cambodia Vietnam Brazil Haiti Peru Argentina
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Home Responsibility Access to medicine Developing countries Research and development Visceral leishmaniasis
Corporate Responsibility Report 2008 Visceral leishmaniasis (VL) Sitamaquine is our oral, once-a-day candidate treatment for visceral leishmaniasis (VL), a potentially fatal disease spread by parasites. Data from two phase ll proof-of-concept studies in Kenya and India are encouraging overall. After a 28-day course, 85 per cent of patients remained cured at six months 1 2 . Sitamaquine was generally well tolerated by patients in these studies. However, there were some concerns regarding renal adverse events seen in a few subjects, some of which appear to be treatment related. Interpretation of these data is complicated, in particular because VL itself is associated with renal impairment. Before proceeding to phase lll trials, we set up a phase llb study 3 to compare the safety and tolerability of a 21-day course of sitamaquine with that of intravenous amphotericin B. Early results showed comparable efficacy to previous studies, despite the shorter course, and sitamaquine was very much better tolerated than amphotericin. A small number of patients had mild, reversible renal side effects. We are currently reviewing the utility of sitamaquine as a potential treatment for VL with regulatory authorities and external stakeholders. 1. Wasunna M, Rashid JR, Mbui J et al. A Phase II dose-increasing study of sitamaquine for the treatment of visceral leishmaniasis in Kenya. Am J. Trop. Med. Hyg. 73(5):2005:871 -876 2. Jha TK, Sundar S, Thakur CP et al. A Phase II dose-ranging study of sitamaquine for the treatment of visceral leishmaniasis in India. Am J. Trop. Med. Hyg. 73(6):2005:1005-1011 3. Prasad LS, Sen S, Ganguly. Renal involvement in kala-azar. Indian J. Med Res 1992 Jan:95;43-46 - Dutra M, Martinelli R, de Carvalho EM et al. Renal involvement in visceral leishmaniasis. Am. J. Kidney Dis. 1985: (6); 22-27
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Home Responsibility Access to medicine Developing countries Research and development Pneumococcal disease
Corporate Responsibility Report 2008 Pneumococcal disease Pneumococcal disease is a global health issue. Each year, Streptococcus pneumoniae infections are estimated to kill one million children under five years of age worldwide. There are more than 90 distinct strains (serotypes) of pneumococcus but only 10-15 cause the vast majority of invasive disease in young children. In January 2009, the European Medicines Agency¶s Committee for Medicinal Products for Human Use issued a positive opinion and recommended approval of GSK¶s paediatric pneumococcal candidate vaccine Synflorix. The paediatric vaccine is proposed to be indicated for active immunisation against invasive pneumococcal disease and middle ear infections (acute otitis media) caused by S.pneumoniae in infants and children from six weeks up to two years. The European Marketing Authorisation for the vaccine is expected to be granted in the first half of 2009. We submitted a file for this potentially life-saving candidate vaccine to the World Health Organization for prequalification in early 2008. Prequalification is a service provided by the WHO to facilitate access to medicines in less affluent countries. We have also been in discussions with the Global Alliance for Vaccines and Immunization to accelerate the availability of funding for pneumococcal vaccination through the pilot Advance Market Commitment (AMC) mechanism. AMCs are a new approach to public health funding designed to stimulate the development and manufacture of vaccines for developing countries. Donors commit money to guarantee the price of vaccines once they have been developed, thus creating the potential for a viable future market.
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Home Responsibility Access to medicine Developing countries Research and development Neglected diseases
Corporate Responsibility Report 2008 Neglected diseases In March 2008, we announced a collaborative research effort with the not-for-profit organisation, Drugs for Neglected Diseases initiative (DNDi), targeting neglected tropical diseases which disproportionately affect the developing world. Research will focus on compounds that may have activity against the most neglected diseases, including visceral leishmaniasis (kala azar), human African trypanosomiasis (sleeping sickness) and Chagas disease. The collaboration, which has been established for an initial period of two years and may be extended, will focus on identifying and developing compounds from existing GSK programmes and will leverage the expertise of researchers from GSK at our Tres Cantos facility along with leading academic centres like the London School of Hygiene & Tropical Medicine. The collaboration has been formed to specifically address unmet patient needs as current treatments for these diseases have significant drawbacks, such as difficulty of administration, severe side effects, length of treatment, cost, and emerging parasitic resistance.
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Home Responsibility Access to medicine Developing countries Research and development Our plans
Corporate Responsibility Report 2008 Our plans In 2009 we plan to: conduct a large-scale phase lll malaria vaccine efficacy trial in seven African countries commence a study focusing on further understanding the safety of tafenoquine in subjects with inherited glucose-6-phosphate dehydrogenase (G6PD) deficiency select a candidate for our lead TB project on mycobacterium gyrase inhibitors development by mid-2009 initiate trails of our candidate TB vaccines in infants continue clinical development of multiple second-generation integrase inhibitors for HIV/AIDS enter µfirst time in human¶ clinical trials on pyridone932121, an anti-malarial being developed in partnership with MMV (this was achieved in January 2009), and select a back up candidate for development by mid2009 review the utility of sitamaquine as a potential treatment for VL with regulatory authorities and external stakeholders.
Pandemic flu If it happens, an influenza pandemic could have a devastating effect, particularly on the poorest countries that have the least resources and capacity to prepare. GSK is very active in global preparations related to pandemic flu. Read more about how we are helping countries prepare for pandemic flu.
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Home Responsibility Access to medicine Developing countries Public-private partnerships
Corporate Responsibility Report 2008 Public-private partnerships GSK must remain profitable to sustain our business and to provide funds to enable us to continue to develop new medicines and vaccines. There is often limited prospect of a commercial return on R&D into diseases of the developing world. Public-private partnership (PPPs) enable R&D into these diseases by making this work commercially viable by sharing the risks and costs involved. PPPs speed up the R&D process and enable all partners to do more than they could do on their own. In a PPP companies such as GSK provide the R&D, technology, manufacturing and distribution expertise. Academic institutions may also provide research and disease area knowledge. Public sector partners, governments and organisations such as the Bill & Melinda Gates Foundation help fund the development and delivery costs and ensure that medicines and vaccines get to the people who need them. Funds are usually channelled through organisations such as the Medicines for Malaria Venture (MMV) which also help to coordinate global R&D activity. PPPs can work in many different ways. For example, some of our partnerships are centred around our dedicated µdiseases of the developing world¶ discovery centre at Tres Cantos and our global vaccines business headquartered in Belgium. GSK provides the facilities for medicinal drug discovery and meets all the running costs. Of the 100 scientists at Tres Cantos, half are subsidised by our partner organisations, MMV and the Global Alliance for TB Drug Development. As compounds move into clinical development, GSK provides the clinical, regulatory and manufacturing expertise and resources through our global R&D and supply network. Partners help fund the cost of running clinical trials and address issues of access and distribution. This reduces the costs of development and gets new products to patients faster. Research programmes are overseen by joint steering committees with representatives from GSK and our partners. Under the terms of our agreements, all new treatments resulting from PPPs are made available to disease endemic countries at affordable prices. Accelerating Access Initiative
The Accelerating Access Initiative (AAI) is a public-private partnership to accelerate access to care and treatment for HIV/AIDS. GSK is a founder member of the AAI, formed in May 2000. The AAI is a partnership between UNAIDS, the WHO, the World Bank, UNICEF and UNFPA, and nine research-based pharmaceutical companies Abbott Laboratories, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, Merck and Co, Inc, Pfizer and Roche. The objectives of the AAI are to: accelerate sustained access and increase use of appropriate, good quality interventions for the prevention/treatment of HIV/AIDS ensure that care and treatment reach significantly greater numbers of people in need, through new alliances involving committed governments, private industry, the UN, development assistance agencies, non-governmental organisations and people living with HIV/AIDS A report from the Accelerating Access Initiative suggests that by December 2007, around 875,000 patients in developing countries were receiving at least one ARV treatment supplied by the nine R&Dbased pharmaceutical companies in the AAI. In the two years since December 2005, the total number of
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patients in developing countries receiving treatment from the AAI companies had increased by 22 per cent. In Africa alone, over 665,600 patients are being treated with at least one ARV supplied by the AAI companies, an increase of 49 per cent over two years. This has resulted in an over 70-fold increase in the number of people being treated with medicines supplied by the AAI companies in Africa since the establishment of the AAI in May 2000.
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Home Responsibility Access to medicine Developing countries Product registrations
Corporate Responsibility Report 2008 Product registrations Approach
Performance and plans
Rapid product registration is important to ensure new medicines reach patients as quickly as possible. But the regulatory process is complex, costly and time consuming. There is little regulatory harmonisation around the world and a distinct submission is required for virtually every country. Companies have to prioritise their regulatory resources. This has led to concerns that pharmaceutical companies are not doing enough to register essential medicines in developing countries, which prevents these countries from taking advantage of preferential pricing offers. We prioritise registration of our medicines based on commercial considerations, as well as prevalence of disease. We use mechanisms such as the European Medicines Agency (EMEA), Article 58, to help facilitate product registration in developing countries. Article 58 allows the Agency's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in cooperation with the World Health Organization, on medicinal products for human use that are intended exclusively for markets outside the EU, such as medicines to treat malaria or leishmaniasis. The positive opinion obtained via Article 58 can then be used to support the registration process in developing countries when conducting their own regulatory reviews. We regularly review the registration status of our key anti-retrovirals (ARVs) to prioritise registration based on the needs for ARVs. This helps to make Epivir, Retrovir, Combivir and Ziagen available as widely as necessary and possible. Screening and vaccination could prevent many thousands of women from getting cervical cancer. We are working to register our vaccine against Human Papillomavirus (HPV), Cervarix, as widely as possible so that women can be better protected from the disease. It is now available in more than 90 high-, middle- and lowincome countries around the world, and GSK is committed to doing what it can to accelerate global access to the vaccine. Read more about our position on cervical cancer prevention.
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Home Responsibility Access to medicine Developing countries Product registrations
Corporate Responsibility Report 2008 Product registrations Approach
Performance and plans
Cervical cancer and rotavirus In October 2007 we submitted Cervarix, our vaccine which helps to prevent infection with HPV, to the World Health Organization (WHO) for pre-qualification. Products with pre-qualification status may be used by UN agencies and the GAVI Alliance, as well as in mass vaccination programmes across the developing world. By submitting Cervarix for prequalification as early as possible, we are working to eliminate the historical 15 20 year delay for new vaccines to become available in developing countries. We anticipate pre -qualification in the first half of 2009. Early in 2007, we received pre-qualification status for our rotavirus vaccine, Rotarix, from the WHO. We concluded a deal with Brazilian government institute Fiocruz to supply enough Rotarix to protect every baby in Brazil against rotavirus for the next five years. This includes a technology transfer agreement under which Fiocruz will produce Rotarix for the domestic market and manufacture Rotarix for GSK under contract for export to other developing countries. This is similar to existing arrangements in Brazil for our oral polio vaccine, Haemophilus influenzae type b (Hib) vaccine and measles, mumps and rubella vaccine. The results of this approach with Rotarix in Brazil have been impressive.
HIV/AIDS GSK produces packs of ARVs specifically designed for and distributed in developing countries. These µaccess¶ packs of Combivir, Epivir tablets, Epivir solution and Trizivir are now registered in at least 33 countries. This means that these products are available for sale in over 50 of our target 64 countries, including those countries which do not have formal regulatory approval processes. Our second-line ARV, Ziagen, is formally registered in tablet form in 28 countries and as oral solution in 23 of our target 64 countries. Ziagen access packs are registered in some of these countries and we are in the process of seeking registration in the others.
Flu To support government preparations for a global flu pandemic, we have registered Relenza in more than 100 countries. Relenza is our anti-viral medicine which can help treat influenza.
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Home Responsibility Access to medicine Developing countries Preferential pricing
Corporate Responsibility Report 2008 Preferential pricing Approach
Performance and plans
Pricing is one factor that impacts on access to medicines and vaccines in developing countries. We price our medicines preferentially for developing countries and use a tiered pricing system in wealthier middleincome markets where people¶s ability to pay for medicines varies significantly. However, price is only one aspect of affordability. The other is ability to pay, which is down to provision and allocation of resources, primarily from governments, and poverty reduction. For the billion people who live on $1 a day, virtually nothing is affordable. Early in 2009 we announced a new strategic approach to pricing in the Least Developed Countries (LDCs) 1. From April 2009 we will reduce our prices for patented medicines in the LDCs so that they are no higher than 25 per cent of the price in the developed world. This will be the maximum price ± where possible we will go further and reduce our prices more aggressively, while ensuring we cover our manufacturing costs so this offer is sustainable. Price reductions in April 2009 will be for 110 products and formulations across Least Developed Countries, with an average price reduction of 45 per cent. We will also reinvest 20 per cent of our profits from LDCs back into projects partnering with organisations such as NGOs to widen access and strengthen the healthcare infrastructure of LDCs. Our sales in LDCs are relatively low so this 20 per cent of profit will be limited ± initially around 1 to 2 million a year. However, by our action we hope to send a signal to all multi-national companies operating in LDCs to join us and contribute to making a difference. In many developing countries the healthcare crisis is dominated by the social and economic impacts of HIV/AIDS, TB and malaria. GSK has both anti-retrovirals (ARVs) to treat HIV/AIDS and anti-malarial treatments in our portfolio. We are committed to increasing access by providing these medicines to the Least Developed Countries and sub-Saharan Africa at not-for-profit prices (see key facts box). We negotiate preferential prices for our HIV/AIDS medicines with middle-income countries on a case-by-case basis. Read more about extending our product portfolio in the developing world.
Vaccines ± our tiered pricing model Vaccines can make a significant contribution to public health , helping to prevent many potentially fatal infectious diseases. Immunisation is acknowledged by the World Health Organization (WHO) as being µamong the most cost-effective of health investments¶. We make our vaccine portfolio available at preferential prices to developing countries, using a tiered pricing system. Prices are linked to gross national incomes as defined by the World Bank as well as the size of an order and length of a particular supply contract. For the developing world, prices can be as little as a tenth of those for developed countries. We work with multinational organisations such as GAVI, UNICEF, the WHO and the Pan American Health Organization, governments and non-governmental organisations to provide appropriate and affordable vaccines for developing countries. We typically supply vaccines to GAVI and UNICEF at 10-20 per cent of developed world prices to these organisations. By selling our vaccines in large volumes through longer-term contracts we are able to significantly reduce the price of each individual dose. This includes basic polio vaccines as well as specially developed combination vaccines that target several diseases. In 2008, of the 1.1 billion vaccine doses we shipped, 78 per cent went
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to the developing world. Many of our vaccines are included in government vaccination programmes in middle-income countries. For example, Rotarix, our rotavirus vaccine, is now included in government vaccination programmes for newborn babies in Brazil, El Salvador, Mexico, Panama and Venezuela. In 2008 we supplied 20 million doses of this vaccine; the vast majority went to developing or middle-income countries. In addition to tiered pricing, we are looking for innovative ways to increase access to vaccines in poorer countries. One option being explored for Cervarix, our vaccine against Human Papillomavirus, is to partner with a major international non-governmental organisation. Through this partnership we will be able to use this organisation¶s distribution networks to increase the supply of our vaccine in developing countries, where most deaths from cervical cancer occur.
Preventing product diversion Product diversion, where not-for-profit medicines are illegally shipped back for sale in wealthier countries, denies treatment to patients in poorer countries. Our anti-diversion measures include specially designed access packs for most of our ARVs, and red rather than white tablets for Epivir and Combivir. We only enter into voluntary licences when we know the manufacturer can ensure product diversion will not occur. 1 As defined by the UN: http://www.un.org/special-rep/ohrlls/ldc/list.htm
Not-for-profit (nfp) prices for medicines ± key facts
GSK has offered preferential pricing for our anti-retrovirals since 1997 and formal not-for-profit (nfp) pricing since 2001. Our nfp prices are sustainable ± we do not make a profit on them, but we do cover our costs. This means that we can sustain supply of these high-quality products for as long as they are needed Not-for-profit prices apply to GSK¶s anti-retrovirals and malaria treatments Nfp prices are available to all the Least Developed Countries and sub-Saharan Africa ± a total of 64 countries In addition, PEPFAR projects and eligible Global Fund projects bring this number up to over 80 countries Eligible customers include public sector customers and nfp organisations as well as private employers in sub-Saharan Africa providing treatment to uninsured staff Combivir, our leading combination ARV, is available at $0.54 a day Our nfp prices include insurance and freight costs, unlike the prices quoted by most generic companies. They are applicable to orders of any size and are not dependent on large order quantities
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Home Responsibility Access to medicine Developing countries Preferential pricing
Corporate Responsibility Report 2008 Preferential pricing Approach
Performance and plans
We offer our anti-retrovirals (ARVs) and anti-malarials at not-for-profit (nfp) prices to public sector customers and not-for-profit organisations in 64 countries - all the Least Developed Countries and all of sub-Saharan Africa. In February 2008 we announced significant new price reductions for our ARVs offered on a nfp basis to these countries. This reduction was the fifth time we have reduced prices as part of our pioneering preferential pricing policy originally introduced in 1997. Combivir, our leading ARV, now sells at $197 per patient per year in the least developed countries compared to $730 in 2001. The most significant reduction, of almost 40 per cent, was on Ziagen oral solution (abacavir). This is recommended by the World Health Organization (WHO) for use in first-line and second-line regimens within resource-limited settings, particularly for children. A number of factors enabled us to implement these price changes, including improvements and efficiencies in manufacturing and supply, and reductions in the costs of active ingredients.
Number of tablets shipped In 2008, we shipped 11.4 million tablets of nfp Combivir and 58.6 million tablets of nfp Epivir to the developing world, compared with 13 million and 72 million respectively in 2007. The decline in supply of our own ARVs is more than outweighed by a growth in volumes from our licensees. In 2008 our licensees supplied over 279 million tablets of their versions of Epivir and Combivir to African countries. Supply of Combivir and Epivir tablets by GSK*
*This includes preferentially priced tablets supplied by GSK and tablets supplied by our licensees.
During 2008 GSK supplied ARVs at nfp prices to 37 countries, compared with 31 in 2007. We will continue to look for new customers for our nfp ARVs in these countries and regularly review our nfp prices. However, it may well be that our licensees are able to produce first-line ARVs at lower costs and will continue to increase their share of the business.
Patients receiving treatment
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It is difficult to estimate the number of patients treated as a result of our preferential pricing agreements, since we do not control healthcare provision. However, the WHO estimates that three million people in the developing world were treated with ARVs by the end of 2007, an increase of one million in a year. A report from the Accelerating Access Initiative (AAI) suggests that by December 2007, around 875,000 patients in developing countries were receiving at least one ARV treatment supplied by the nine R&D-based pharmaceutical companies in the AAI. In the two years since December 2005, the total number of patients in developing countries receiving treatment from the AAI companies had increased by 22 per cent. In Africa alone, over 665,600 patients are being treated with at least one ARV supplied by the AAI companies, an increase of 49 per cent over two years. This has resulted in an over 70-fold increase in the number of people being treated with medicines supplied by the AAI companies in Africa since the establishment of the AAI in May 2000. Read more about how a GSK vaccine has contributed to the elimination of Hib mengingitis.
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Home Responsibility Access to medicine Developing countries Pricing in middle-income countries
Corporate Responsibility Report 2008 Pricing in middle-income countries Approach
Performance & plans
Middle-income countries (MICs), such as Brazil, China, Thailand and Indonesia, and some low-income countries such as India are more economically developed than the world¶s poorest countries, and often have a large and affluent middle class. They therefore provide greater commercial opportunities than the world¶s poorest countries. According to a report by accounting firm, PricewaterhouseCoopers, the growing wealth of Brazil, China, India, Indonesia, Mexico, Russia and Turkey means they could account for 20 per cent of the global pharmaceutical market by 2020. However, many middle income countries also have large numbers of people living in extreme poverty and healthcare demands often outstrip available resources. These challenges are made worse by an increasing incidence of chronic diseases such as asthma and diabetes. To reflect this situation, in 2008 we restructured our commercial organisation. We split our old International division and created two new regions ± Emerging Markets and Asia Pacific. This will enable us to respond to commercial opportunities while reflecting the healthcare environment and individual needs. Increasing access to medicines in middle-income countries within a responsible commercial framework is complex. It is clear that there is no one universal µone size fits all¶ solution. This complexity was a key aspect in the Pharma Futures 3 dialogue, which explored the links between sustainable pharmaceutical business models and improved health outcomes in middle-income markets, including China, India and Brazil. It is vital that we identify the best approaches for GSK to address these complex challenges. The challenges include: Low government healthcare spend relative to gross domestic product (GDP). This can be as low as one per cent of GDP compared with an average of nine per cent in the EU Poor healthcare infrastructure, including hospitals, clinics, doctors and nurses A high level of income inequality within countries, which can complicate pricing considerations The affordability of medicines and vaccines Taxes and mark-ups on medicines and vaccines Stigma and discrimination associated with certain diseases Use of traditional medicines Remote rural populations We recognise that many middle-income countries need assistance. However, we believe a different approach is needed from the one we take in the world¶s poorest countries. Our offer to supply medicines at not-for-profit prices and vaccines at highly preferential prices in the world¶s poorest countries is only sustainable if we can continue to make an adequate return on them in wealthier markets. Many middle-income countries are also growing commercial markets for GSK and represent an
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important source of future business for our industry. Our response in these markets must therefore balance our commercial objectives with our global commitment: to work with governments and other stakeholders to support efforts to deliver our medicines and vaccines to as many needy people as possible. Our approach combines long-established practices such as voluntary licences, tiered pricing for vaccines and preferential pricing for HIV/AIDS and malaria medicines with more innovative strategies that focus on the different socio-economic groups within individual MICs.
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Home Responsibility Access to medicine Developing countries Pricing in middle-income countries
Corporate Responsibility Report 2008 Pricing in middle-income countries Approach
Performance & plans
Our approach to pricing in middle-income markets is constantly evolving and ongoing pricing pilot programmes are informing this evolution. These comprise a mixture of long-established practices and new approaches. We intend to formalise and communicate on our pricing policies in middle-income countries during 2009.
Long-established practices Tiered pricing for vaccines Our vaccines are available to 18 GAVI-eligible middle-income countries (MICs), including Indonesia, Sri Lanka and Cuba, at highly discounted prices. Many of our vaccines are also included in government vaccination programmes in middle-income countries. Preferential pricing for HIV/AIDS and malaria medicines We negotiate preferential pricing arrangements for HIV/AIDS medicines and anti-malarials with middleincome countries on a case-by-case basis. This is done bilaterally through dialogue with governments. We believe this approach is appropriate because the burden of disease and the resources available to address that burden vary significantly from country to country, and within countries. These arrangements combine a viable and sustainable commercial return for GSK with improved affordability for the healthcare systems concerned.
Novel approaches We are developing a more flexible, responsive approach to accessing private and public sector markets in MICs. Our strategy focuses on the different socio-economic groups within individual MICs. It uses the standard classifications for socio-economic groups, the A group being the wealthiest section of society and E being the poorest. Typically, a company such as GSK makes a disproportionate share of its sales to people in the A/B group with sales tailing off quite sharply in the C/D group. Usually we will be unable to compete with low-cost generic medicines for sales to the E group. We believe the most productive way for us to align our commercial and accessibility goals is to make our products more readily available to the C/D segment of the market. This will free up more government funding for the poorest segment of the population. We are exploring options through projects including: Tiered pricing models within as well as between countries, including those which enable products to be priced differently for the private and public health sectors Gauging the relationship between price and volume for selected products in targeted MICs. For example, we may be able to reduce the price of products where we have orders for a sufficiently high volume of products Local sourcing and manufacturing arrangements designed to address cost issues It is too early to draw definitive conclusions from these pilot projects and some results from the pilots are commercially sensitive. In the pilots investigating the relationship between price and volume, the volume
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targets were not achieved and the analysis was confounded by unexpected factors such as reduced demand for our diabetes medicine Avandia. However, it is clear that there are no simple or universal solutions. We have learned from the projects and will continue to investigate these approaches and establish further pilots where initial pilots have proved inconclusive. For example, we are exploring options such as within-country tiered pricing for vaccines. It is clear that pricing decisions cannot be assessed in a vacuum and other factors, such as market dynamics including new product introductions and how competitors react to our price changes, have to be taken in to account. It is also evident that not every programme will be suitable for every middle-income country. These pilots are therefore helping to inform our approach in middle-income countries. We are confident that the more successful elements will be incorporated into our long-term commercial strategy and we plan to report more on this during 2009. Cervarix price reduction ± Philippines, Vietnam, Indonesia and South Africa
GSK works in partnership with stakeholders to optimise the availability of its vaccine against human papillonnavirus. Improving access to treatment requires many stakeholders working together to develop better infrastructure, distribution channels, adequate funding, better disease awareness and education and the appropriate market dynamics. GSK is committed to ensuring pricing is not a barrier to access in the developing world and has reduced prices in the Philippines, Vietnam, Indonesia and South Africa. For example, in the Philippines we have reduced the price of Cervarix by 60 per cent. In South Africa, the price reduction is of the order of 40 per cent. GSK has a long track record of tiered pricing for vaccines available in government-led programmes, where we charge reduced prices in countries with lower levels of income. The reduction of the price for Cervarix in a number of countries is a further demonstration of our commitment to increasing access to our vaccines.
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Home Responsibility Access to medicine Developing countries Voluntary licensing
Corporate Responsibility Report 2008 Voluntary licensing Approach
Performance
Voluntary licences are granted by patent holders to allow a generics company to manufacture and sell their products. Some people assume that generics are always cheaper than branded products and are seen by many as a key solution to the access crisis in the developing world. Pharmaceutical companies are under increasing pressure to grant licences. However, generics are not always cheaper and the success of a voluntary licence will depend on the right licensees being chosen. This is particularly true for the treatment of a chronic disease like HIV/AIDS, where the sustainable supply of good-quality anti-retrovirals (ARVs) is key. We do not believe that voluntary licences are a universal solution to tackling HIV/AIDS or disease in general. In most cases local manufacture of ARVs will make little difference to their affordability and access to patients. This is a point endorsed by the WHO. This is because the real barriers to access are the lack of healthcare infrastructure and resources to pay for medicines regardless of where they come from. However, funding from the World Bank and other international donors has meant that voluntary licences can have a role to play in efforts to tackle the HIV/AIDS epidemic in sub-Saharan Africa by helping to increase the availability of medicines and contribute to better security of supply. A decision to grant a voluntary licence depends on a number of factors including, in the case of HIV/AIDS, the severity of the epidemic in that country, local healthcare provision and the economic and manufacturing environment. We discuss voluntary licences with potential partners on a case-by-case basis. We need to be sure that the manufacturer can provide a long-term supply of good-quality medicines and will implement safeguards to prevent the diversion of medicines to wealthier markets. We continue to consider the role of voluntary licensing in helping to increase access to medicines in middle income countries without undermining our commercial business.
Compulsory licences Compulsory licences are issued by governments and involve intellectual property rights being taken away from the rights holder. Compulsory licences are one of the flexibilities in the World Trade Organization ¶s TRIPS agreement on intellectual property which can be used for humanitarian purposes. However, widespread use of compulsory licences will undermine the intellectual property framework and be counterproductive in the long term. R&D into new treatments, especially where commercial markets exist such as for HIV/AIDS, depends on protection of intellectual property.
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Home Responsibility Access to medicine Developing countries Voluntary licensing
Corporate Responsibility Report 2008 Voluntary licensing Approach
Performance
We granted our first voluntary licence (VL) in 2001 and have now negotiated eight licensing agreements for our ARVs in Africa. Some of our VLs cover individual countries or trade blocs while others cover all of sub Saharan Africa. Update August 2009
In July 2009 we agreed a royalty free voluntary licence to enable Aspen to produce our ARV abacavir. This takes the total number of licensing agreements for ARVs in Africa to nine. The offer to grant licences for abacavir is open to all our licensees. In August 2007 we gave consent to enable a Canadian company, Apotex, to manufacture a generic fixeddose combination ARV, containing two molecules over which GSK has patent rights, for the treatment of HIV/AIDS in Rwanda. This consent was granted under Canada¶s Access to Medicines Regime which reflects the WTO µ31f¶ agreement. This enables governments to authorise the production of certain patented medicines for export. GSK agreed to waive royalties on the basis that Apotex¶s triple combination generic ARV will be supplied on a not-for-profit basis. Our licensees supplied 279 million tablets of their versions of Epivir and Combivir to Africa in 2007. This represents more than 50 per cent growth over 2007, and 130 per cent more than in 2006. We welcome this trend as it gives customers in sub-Saharan Africa greater choice and contributes to better security of supply. We have granted a VL to Simcere, a Chinese manufacturer, granting them the right to manufacture and sell zanamivir (Relenza) containing products in China, and to sell in a number of other countries including all 50 of the least developed countries. Zanamivir is an anti-viral which can help treat influenza and the VL was driven by a specific concern to help ensure sufficient supplies in the event of a global flu pandemic. Collaboration with local manufacture significantly reduces disease burden of rotavirus ± Brazil
We pursue initiatives that have both high public health impact and are commercially viable. An example of this can be seen in the implementation of universal mss vaccination (UMV) programmes in Brazil against rotavirus. GSK and the Brazilian vaccine manufacturer Fiocruz have had a long-standing partnership for the production of vaccines for diseases causing high mortality and morbidity such as polio, Haemophilus influenzae type b (Hib), measles, mumps, rubella and most recently rotavirus. The partnership between GSK and Fiocruz supports all of Brazil¶s requirements for universal mass vaccination against rotavirus with the Rotarix vaccine. Despite incomplete coverage, the vaccination programme has significantly improved public health: A 29 per cent reduction of all hospitalisation due to acute diarrhoea of any aetiology in 2007 An 85 per cent reduction of rotavirus-related hospitalisations 1 A reduction in diarrhoea outbreaks due to rotavirus in Smo Paulo from 36 per cent in 2004 to 8 per cent
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in 2008 A reduction in the proportion of cases of gastroenteritis caused by the rotavirus from 88 per cent in 2004 to 1 per cent in 2008 The rotavirus vaccine is expected to lead to 703 avoided deaths (75 per cent reduction) and 1.7 million avoided cases (54 per cent reduction). 1. Brazilian Ministry of Health statistics
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Home Responsibility Access to medicine Developed countries
Corporate Responsibility Report 2008 Developed countries Approach
Performance
Access to medicines is not only an issue for the developing world. Even in developed countries some patients cannot afford the medicines they need. This is a particular problem in the US where many people do not have health insurance and there is limited public health provision. We have developed Patient Assistance Programs (PAPs) and discount savings cards in the US and we have introduced discount cards in some middle-income countries.
Programmes in the US Our Patient Assistance Programs (PAPs) and discount savings cards provide prescription medicines to uninsured patients in the US free or at minimal cost. GSK operates several programmes, including Commitment to Access, which covers cancer treatments, and Bridges to Access, which covers other medicines for outpatients. Patients are registered trough one phone call from a patient advocate and receive medicine at their local pharmacy or by mail order. GSK Access provides extra help for low-income senior and disabled patients enrolled in Medicare Part D. This programme provides free medicines for eligible patients who have spent $600 or more on prescription medicines during the current year, and whose income is between 135 per cent and 250 per cent of the Federal Poverty Level. The Federal Poverty level is about $11,000 for a single person, $14,500 for a couple and $22,000 for a family of four. We are a member of Together Rx Access, an industry programme which gives uninsured US citizens 25 to 40 per cent discounts on medicines from GSK and seven other pharmaceutical companies. The programme is open to people who earn up to four times the federal poverty level. Nearly two million Americans are enrolled in Together Rx Access. We are also working with governments and employers in the US to find new ways to address the problem of chronic diseases while reducing healthcare costs
Discount cards in other countries GSK has introduced discount cards in Lithuania and Ukraine to enable low-income patients with chronic diseases such as asthma to obtain prescription medicines at a discount price.
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Home Responsibility Access to medicine Developed countries
Corporate Responsibility Report 2008 Developed countries Approach
Performance
Programmes in the US In 2008, more than 415,000 patients received GSK medicines worth over 56 million through our US programmes. The value of our medicines is calculated using an average cost of goods rather than the wholesale acquisition cost (WAC) that we have used in previous years. This new approach to valuing medicines more accurately reflects the true cost to GSK and is therefore more transparent. We believe we are the first pharmaceutical company to adopt this practice. The number of patients using our largest patient assistance programmes declined by eight per cent compared with 2007. This is due to a decline in sales for Avandia and generic substitution for Coreg and Paxil. There may also have been an increase in the number of people without insurance delaying visits to the doctor. This year more than 8,000 patients received over 21,000 30-day prescriptions of GSK medicines through the Together Rx Access programme, giving patients discounts of more than $1.2 million. Since its inception in 2002, Together Rx Access has given nearly two million patients savings totalling $80 million across a wide range of products.
Discount cards in other countries In Lithuania, our Orange Card gives senior citizens and the disabled a discount of up to 60 per cent on the patient co-payment on all GSK prescription medicines. So far more than 60,000 patients have applied for an Orange Card and over 450 pharmacies (30 per cent of the pharmacies in Lithuania) are registered to participate. In 2008 the total discount given was 450,000. Our Orange Card in Ukraine gives significant discounts to all asthma and chronic obstructive pulmonary disease patients who need financial support for purchasing Seretide, our inhaled treatment for asthma and chronic obstructive pulmonary disease. In 2008 more than 19,000 patients received e-Orange Cards and 326 pharmacies were registered to participate in the programme. In 2008 the total discount given on GSK products was 658,000.
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Home Responsibility Access to medicines Pricing our medicines
Corporate Responsibility Report 2008 Pricing our medicines Prices for newly approved medicines are determined on a country-by-country basis. In some countries, prices are negotiated directly with governments or other payers, for example sickness funds and private health insurers. In others, manufacturers are free to set their own prices subject to other kinds of government controls. Pharmaceutical R&D is a lengthy and expensive process. To develop one successful medicine or vaccine it can take, on average, ten to twelve years and typically costs around $1.2 billion 1. For every product that reaches the market, thousands do not make it through the research process. We seek to ensure that the price of our new products reflects: Their clinical value to patients in terms of improved therapy, better safety and fewer side effects The high risks associated with R&D The need for a fair return on investment Affordability for our customers Ultimately, national price regulation will often amount to a balancing act between managing public healthcare budgets, enabling patient access and rewarding innovation and R&D investment. We sell our medicines to wholesalers and pharmacies, not directly to patients. These intermediaries often add their own price mark-ups to pharmaceutical products, and in addition duties and tariffs may be imposed on imported products. This affects the price paid by the end customer, for example national health services, hospitals and patients. 1. Tufts Center for the Study of Drug Development
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Home Responsibility Access to medicines Intellectual property
Corporate Responsibility Report 2008 Intellectual property Intellectual property (IP) refers to creations of the human mind. There are laws in most countries to stop those creations being used by others. These include patents, copyrights and trademarks. At an international level, IP is protected through the World Trade Organization¶s (WTO) Trade Related Aspects of Intellectual Property Rights Agreement, commonly known as TRIPS. Patents and other IP rights play a vital role in encouraging the innovation needed to develop new treatments for many of the most serious and life-threatening diseases. We invest considerable time and money to develop each new pharmaceutical product - an average of $1.2 billion 1 and 10-12 years per product. For every 5,000 to 10,000 compounds tested, an estimated five reach clinical trials and only one reaches the market 2. If a new product could immediately be copied and sold by others, we would not be able to continue to fund new research. This would discourage innovation and limit research into newer and better medicines and vaccines. In relation to the healthcare crisis in the developing world, intellectual property, specifically patents, has been criticised for two broad reasons. Opponents claim that: The market-driven IP-based R&D system has led to a mis-prioritisation of R&D resources. This means that R&D prioritisation is based on developed world market opportunities rather than on unmet medical need. This has led to an R&D deficit into diseases of the developing world IP has acted as a barrier to access. This has two facets: firstly patents have led to monopoly pricing and have prevented generic competition being able to drive prices down. Secondly, patents have acted as a barrier to follow-on innovation such as the development of fixed-dose combinations We believe that these concerns have been overstated, but we recognise that we need to seek new approaches to IP to help tackle the healthcare crisis. We believe that the IP system is compatible with R&D into diseases of the developing world. GSK and others in the industry have expanded research into neglected diseases in recent years. In November 2008 the international trade association, the IFPMA, published data that showed that the number of medicine and vaccine projects undertaken by companies with product development partnerships or on their own had increased to 67, up from 58 in November 2007 3. We believe that patents are a minor issue in preventing people in the developing world from getting access to medicines. There is little or no patent protection for many vital medicines such as treatments for malaria, tuberculosis and diarrhoeal diseases, which kill millions of people a year. Over 95 per cent of the medicines on the World Health Organization¶s (WHO) Essential Medicines List are not patent protected anywhere in the world, yet the WHO says that one-third of the world¶s population does not have regular access to these drugs. In Africa and parts of Asia this figure rises to two-thirds of the population. Poverty is the biggest barrier to effective healthcare in the developing world because it is usually associated with a poorly developed healthcare infrastructure with little or no access to doctors and hospitals. The significant barriers that stand in the way of access to medicines in the developing world must be tackled as a shared responsibility by all sectors of global society. However, traditionally we have only allowed access to our intellectual property in very controlled situations. We are now exploring ways to be more flexible with our intellectual property that relates to neglected diseases.
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IP¶s primary objective is to incentivise and reward research. However, there are a number of neglected tropical diseases, such as leprose and cholera, where there is a serious lack of research, for a variety of complex reasons. We need to explore how to address this gap, including the use of IP. One approach might be for a patent pool to encourage more research into neglected tropical diseases. GSK is placing over 500 granted patents and over 300 pending applications, relating to approximately 80 patent families, in a pool to help others to develop potential medicines for neglected diseases. In addition to providing access to these patent filings, GSK will set out a mechanism to enable third parties to request access to other intellectual property and know-how about its medicines which may help researchers to develop new medicines for neglected tropical diseases. The aim of any such pool must be to encourage research that would otherwise not happen. If, as we hope, something new comes out of such research, then the full benefits must go directly to the LDCs. Such a pool has to be voluntary, so as to foster an atmosphere of cooperation and to encourage others to join. A pool is one mechanism we are exploring to achieve these aims. We will also consider new ways of stimulating research. We will continue to defend our IP robustly outside the pool. Our business is sustained through being rewarded for the discovery and development of innovative medicines. However, in the poorest countries we plan to be much more flexible and will develop our work in this area throughout 2009. Intellectual property laws can help prevent the distribution of counterfeit products, which present a serious health risk for patients. 1. Tufts Center for the Study of Drug Development 2. Pharmaceutical Industry Profile 2008, Washington DC, PhRMA March 2008 3. www.ifpma.org/News/NewsReleaseDetail.aspx?nID=10975
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Home Responsibility Access to medicines Intellectual property WTO and TRIPS agreement
Corporate Responsibility Report 2008 WTO and the TRIPS Agreement Intellectual property (IP) rights are protected globally by the World Trade Organization¶s (WTO) Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS). The TRIPS Agreement was signed by all WTO member countries in 1994 and covers all types of IP including patents, copyright and trademarks. It sets minimum standards for IP rights in all WTO member countries. The Agreement covers all areas of business and society including software, music and the arts, and is designed to encourage innovation in all business sectors. Developing countries have been given extra time to comply with TRIPS. Some countries, for example India, had until 2005 to introduce patents for pharmaceuticals. The 50 least developed countries of the world, for example Rwanda and Gambia, have until 2016 to comply with the Agreement for pharmaceuticals, and until 2013 for all other sectors.
Patents, TRIPS and access to medicines There have been concerns that patents and the TRIPS Agreement restrict access to medicines for people in developing countries, by making it difficult for them to obtain cheap generic versions of important drugs such as those used to treat HIV/AIDS. However, the TRIPS Agreement contains a number of public health safeguards that have been clarified by the WTO. Concerns over TRIPS and access to medicines were addressed in 2001, at the WTO ministerial conference in Doha, when WTO ministers confirmed that IP protection is important for the development of new medicines and that it does not and should not restrict members¶ rights to protect public health. They also agreed that the TRIPS Agreement could and should be implemented and interpreted in a way that supports public health and promotes access to medicines. This understanding was captured in the Doha Declaration on TRIPS and Public Health (the Doha Declaration), which confirmed the rights of member countries to use the flexibilities in TRIPS such as compulsory licences to protect public health priorities. Compulsory licensing allows governments to issue a licence so a patented product can be manufactured without the consent of the patent owner. The WTO members further agreed to modify the TRIPS provisions relating to compulsory licensing in August 2003 so that countries unable to produce pharmaceuticals domestically can import patented products made under compulsory licences abroad. This provision was confirmed as an amendment to the TRIPS agreement by the WTO in December 2005. GSK supports the Doha Declaration and the agreement on compulsory licensing. We are committed to playing a key role in the access crisis.
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Home Responsibility Access to medicines Intellectual property Intellectual property rights in brief
Corporate Responsibility Report 2008 Intellectual property rights in brief Patents A patent gives the inventor of a new product the exclusive rights to manufacture, use, sell or import that product or the process used to make it. These rights are granted for a set period, generally 20 years. The term of the patent runs during the lengthy research and development (R&D) period, and often only five to eight years of the patent remains once a product is marketed. Some countries have extended the patent term to compensate for the long R&D process. Patents are granted on the condition that the inventor publishes a full description of the invention, which would allow someone else to manufacture the product. This helps to build scientific understanding and encourage further research and innovation.
Trademarks A trademark is a brand name, word, phrase, symbol or design, or a combination of these, that identifies and distinguishes a product or company. The owner of a trademark can prevent its use by a third party. Trademarks enable our customers to tell our products from those of our competitors and provide reassurance of quality and the origin of the product. They are therefore a vital part of our marketing.
Data exclusivity Before we can sell a new product we must prove that it is effective and safe to use. All our products are rigorously tested through clinical trials and other medical research. The results of this research are submitted to governments on a confidential basis. Data exclusivity means that governments cannot use or disclose these data for a fixed period. This ensures that other companies cannot benefit from our research for free - for example to demonstrate the safety and efficacy of generic copies of our products. In the interest of facilitating timely market access and the need to avoid repetitive animal testing and human clinical trials, competitors may refer to our data after expiration of the period of exclusivity.
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Home Responsibility Access to medicines The future
Corporate Responsibility Report 2008 The future Increasing access to medicines is a global challenge. While encouraging progress has been made in some areas, significant problems remain and new issues are likely to emerge. For example: The continued need for a significant scale-up of treatment for HIV/AIDS in sub-Saharan Africa, in resourcepoor settings A potential global flu pandemic The healthcare needs of poor people in middle-income countries The growing impact of non-communicable diseases such as diabetes in poor and rich countries The death of 2.5 million children each year from vaccine-preventable diseases In 2009 we will implement programmes in a number of areas to help address these challenges: Intellectual property ± we will explore ways to be more flexible with our intellectual property rights as they relate to neglected diseases, including exploring the idea of patent pools. We believe that this could speed up the development of new medicines and will encourage other pharmaceutical companies to adopt a similar approach. Update August 2009
On 24 March 2009 we launched an LDC Neglected Tropical Disease Patent Pool website which enables interested stakeholders to: Access a list of GSK¶s patent filings on small molecule pharmaceuticals for the treatment of neglected tropical diseases (NTDs). Organisations can apply for licences in areas where we are not developing treatments; Request licences to research and develop a treatment for an NTD using a GSK patented technology for small molecules that we are not currently developing; Get our help with problems arising in their research and development into small molecule therapeutics to treat NTDs in Least Developed Countries. In July 2009, the US biotechnology group Alnylam became the first company to follow GSK and contribute some of its patents to the pool. Pricing ± we will improve transparency in our pricing policies and implement our new pricing policies in least developed countries and continue to evolve new approaches to increase affordability in middleincome countries Update August 2009
On 1 April 2009 we implemented price reductions on our patented products in the Least Developed Countries (LDCs). Our commitment is that all GSK patented products in these countries will now cost less than 25 per cent of their price in the referenced developed countries.
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We reduced prices for seven patented brands (110 individual product lines and formulations) by an average of 45 per cent. In some countries prices were not reduced immediately due to regulatory processes such as needing to obtain government authorisation, however the price reduction process was initiated. We also cut prices in some non-LDC markets in East Africa and Francophone West Africa to reduce the risk that products would be diverted from the LDCs and sold in these wealthier countries, thereby reducing their availability in the LDCs. Research ± we will evaluate opportunities to expand our Tres Cantos µdiseases of the developing world¶ research centre into a world-class, global centre of excellence. We will do this by encouraging partnerships with governments, NGOs and other pharmaceutical companies. Update August 2009
We have appointed a leadership team and are working with partners to extend the capacity and scope of the Tres CantosIDFLOLW\:HDUHFUHDWLQJDPRUHRSHQDQGFROODERUDWLYH way of working and providing the IDFLOLWLHVDQGVXSSRUWQHWZRUNQHHGHGIRUYLVLWLQJVFLHQWLVWVWRIRUPGUXJGLVFRYHU\SURMHFWWHDPVZLWK GSKVFLHQWLVWV Healthcare services ± we will seek to partner with governments and other stakeholders to help to strengthen healthcare infrastructure and services Update August 2009
Through our reinvestment initiative GSK will support the governments of five LDCs in addressing priority healthcare challenges, to remove some of the barriers to quality healthcare and to strengthen health infrastructure. This will be achieved through targeted partnerships that will increase access to essential PHGLFLQHVDQGEDVLFKHDOWKFDUHVHUYLFHV7KHZRUNZLOOEHJLQEHIRUHWKHHQGRI In four of the LDCs - one each from the GSK regions of East Africa, Southern Africa, Anglophone West Africa and Francophone West and Central Africa - we will be expanding our maternal and child health activities, with specific focus on children under five through the Integrated Management of Childhood Illness programme. In one additional LDC we will be piloting a new Child Family Wellness (CFW) model. The CFW microfranchising model involves building a network of micro pharmacies and clinics to improve access to essential medicines, basic healthcare and prevention services for children and families. The work will use business models that maintain standards, are readily scalable, and achieve economies of scale. GSK is currently working with an NGO, the HealthStore Foundation, which has implemented the model in Kenya, to run viability studies in at least two LDCs in East Africa. We will then select one country in which to implement the initiative. In July 2009 we announced new commitments to fight HIV/AIDS in Sub-Saharan Africa, with a special focus on the care and treatment of children. They include 10 million seed funding to support a public private partnership for research and development of new HIV/AIDS medicines for children, a commitment to seek collaborations with other companies to develop fixed -dosed anti-retroviral combinations, and the creations of a 50m Positive Action for Children Fund .
We are working with the main industry associations on new initiatives to increase R&D and improve access. The first outcome of this activity was the announcement in January 2008 of a grant of $1 million by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) to the Special Programme for Research & Training in Tropical Diseases (TDR), co-sponsored by UNICEF, UNDP, the World Bank and the WHO. The grant will support TDR¶s development of new medicines to combat diseases that disproportionately affect poor people living in developing countries. Other activities include plans to establish a pilot industry consortium to focus on developing new targets (molecules that can prevent or interrupt disease progression) against diseases of the developing world. Update August 2009
In April 2009 we announced our intention to combine the GSK and Pfizer HIV businesses to create a new
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companyGHGLFDWHGWRWKHGLVFRYHU\DQGGHOLYHU\RI+,9WUHDWPHQWV%\FRPELQLQJWKHEXVLQHVVHVZH will create a specialist unit that is more sustainable and broader in scope than either company¶s individual business. The new company will particularly look to improve treatments and formulations for children living with HIV. We will continue to offer HIV medicines at not-for-profit prices in the world¶s poorest countries, and to issue new voluntary licences to diversify production and expand capacity in these markets. The new company will be responsible for delivering on the commitments announced by GSK in July 2009.
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Home Responsibility Access to medicines Response to assurance recommendations
Corporate Responsibility Report 2008 Response to assurance recommendations Bureau Veritas assured the Access to medicines section of our CR Report 2007 (see details on pages 49-50) and made recommendations for how we could improve our reporting on access to medicines in four key areas. Below we report these challenges and how we have responded: 1. Vision ± GSK could further enhance and communicate its overall vision and strategy on access to medicines. This should demonstrate a holistic, long-term approach; articulate the business case; provide context and explain how it is integrated into its overall business strategy. GSK response: In June 2001, GSK published µFacing the Challenge¶ which summarised our approach and contribution to improving access to medicines, and the principles underlying our approach. In 2008 Andrew Witty assumed the position of CEO of GSK and instigated a review of our approach to access to medicines. In a major speech at Harvard University in February 2009, Andrew Witty set out our approach to improving access to medicines in the developing world and the initiatives we will implement in 2009. 2. Governance ± GSK should provide greater detail on the governance, accountability and management structures for access to medicines and the relationship with external stakeholders. GSK response: Abbas Hussain, President of Emerging Markets at GSK, leads our access efforts which are also reviewed by the Corporate Executive Team, GSK¶s most senior management team, and by the Corporate Responsibility Committee of the Board. In 2008, we have continued to engage with stakeholders on access issues including the ATM Index and participating in the development of a report on GSK¶s approach by Paul Hunt, the UN Special Rapporteur on the Right to Health. 3. Transparency ± GSK provides significant information and case studies but should also consider how to provide greater transparency on the impacts of its access to medicines initiatives and how to put these into context in relation to its overall operating model. GSK response: Assessing the impacts of our access to medicines programme is a challenge. We report data on the number of tablets shipped through our preferential pricing programmes and voluntary licence agreements, but it is difficult to translate these figures into numbers of patients receiving treatment as we are not involved in healthcare delivery. Our medicines are also used in combination with medicines supplied by other pharmaceutical companies, so simply converting our shipments into patient numbers would be misleading. The Accelerating Access Initiative (AAI), a public-private partnership working to combat HIV/AIDS, calculates treatment rates using medicines supplied by the nine R&D-based pharmaceutical companies involved in the partnership. It estimated that by December 2007, around 875,000 patients in developing countries were receiving at least one ARV treatment supplied by the companies. Where we are able to generate robust data on the impact of our programmes we will seek to do so. For example in October 2008 significant data on the lymphatic filariasis (LF) elimination programme was published in the Public Library of Science (PLoS) Journal of Neglected Tropical Diseases 1. The study found that, in the ten years since GSK¶s commitment, the LF elimination programme has prevented 6.6 million children from acquiring LF and stopped a further 9.5 million infected people from progressing to more debilitating stages. All of this is the result of the fastest-growing drug administration programme in public health history, delivering what the study calls the µbest buy in public health¶.
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4. Measuring performance ± linked to transparency, GSK should consider how to provide relevant indicators that demonstrate the implementation of a long-term strategy and promote comparisons across the industry. GSK response: We welcome comparisons across the industry on performance on access to medicines; however, since approaches differ significantly between companies, making meaningful comparisons is a challenge. What is right for one company may not be right for another. A method of ranking companies on their approach to access to medicines was developed during 2008, the Access to Medicines Index. GSK was ranked top in the first Access to Medicines Index, published in 2008. The Index rates companies according to their performance on eight criteria: management, influence, research and development, patenting, capacity, pricing, drug donations and philanthropy. We are pleased that our efforts to make our medicines more available have been recognised by the Index. Additionally, during 2008 we were asked by Paul Hunt, the UN Special Rapporteur on the Right to Health, to contribute to a report he was preparing on GSK¶s approach to access to medicines. We cooperated fully and a number of senior executives, including our former CEO, Dr JP Garnier, and our Chairman Sir Christopher Gent, were interviewed. We expect the report to be published in the first half of 2009. 1 www.plosntds.org/article/info:doi/10.1371/journal.pntd.0000317
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Home Responsibility Access to medicines Case studies
Corporate Responsibility Report 2008 Case studies Potential malaria vaccine Malaria kills more than one million people a year worldwide and makes millions more sick, most of them children living in sub-Saharan Africa. The international community urgently needs a safe and effective vaccine to control the disease. A vaccine, even with a partially effective profile, is a necessary component of a comprehensive malaria control programme and could potentially save hundreds of thousands of lives a year. Our malaria vaccine candidate RTS,S is the most clinically advanced malaria vaccine candidate in the world. Since its discovery by GSK scientists in 1981, GSK has invested over $300 million of its own resources in progressing RTS,S to phase lll trials. A full set of clinical trials for a successful vaccine candidate can take 10 to 12 years, involve 50,000 to 100,000 volunteers, and cost $500 million or more. Few vaccine candidates survive this rigorous process, which is one reason why pharmaceutical research and development is so expensive. Creating a malaria vaccine for young children and pregnant women - one of the most important vaccine-development challenges today - is no exception. In January 2001, GSK and MVI (PATH Malaria Vaccine Initiative), with support from the Bill & Melinda Gates Foundation, entered into a public-private partnership to develop an RTS,S-based vaccine for infants and children living in malaria endemic regions in sub-Saharan Africa. The clinical development of RTS,S is conducted by the Clinical Trial Partnership Committee, a collaboration of leading African research institutes, Northern academic partners, MVI and GSK with support from the Malaria Clinical Trial Alliance. To date, GSK has invested over $300 million of its own resources to develop the vaccine. In December 2008, the New England Journal of Medicine published results of two separate studies demonstrating that the malaria vaccine candidate provides both infants and children with significant protection against malaria. In infants, data showed for the first time that the vaccine candidate can be administered as part of existing African immunisation programmes 1. In children aged five to seventeen months, the candidate RTS,S/AS01 reduced the risk of clinical episodes by 53 per cent over an eight -month follow-up period 2. RTS,S is now entering pivotal phase lll studies, which will be the world¶s largest malaria vaccine trial to date, involving 16,000 participants in 11 centres in Africa. Most of the places we are doing our trials have limited healthcare infrastructure. With partners we have therefore helped to set up these 11 clinics in seven African countries, with each training doctors, nurses and laboratory staff. We hope this infrastructure will remain long after the trials are completed. Update August 2009
The Phase III trial of the RTS,S malaria vaccine candidate started in Bagamoyo, Tanzania, in May 2009. The children who need this vaccine are among the poorest in the world. Price cannot be a barrier to access and we will work with supply organisations such as GAVI and UNICEF to ensure the price is set at the right level. We are also committed to working with the international community to mobilise the resources to fund the vaccine and the infrastructure needed to deliver it. 1. Abdulla S, Oberholzer R, Juma O, et al. Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med 2008;359:2533-44. 2. Bejon P, Lusingu J, Olotu A, et al. Efficacy of RTS,S/AS01E : clinical malaria in 5 to 17 month old children. N Engl J
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Extending our product portfolio in the developing world ± low- and middleincome countries In July 2008 GSK entered a partnership with the South African pharmaceuticals company Aspen. This is in line with our aim to grow a diversified business and operate in a way that is adapted to patient needs in low and middle-income markets. Aspen¶s product portfolio covers a broad range of therapy areas relevant to the disease profile in developing countries, including: analgesics (for pain relief), anti-hypertensives (for high blood pressure), bronchodilators (for the treatment of asthma), anti-bacterials, anti-gout agents, anti-inflammatory agents, anti-depressants, anti-fungal agents, anti-histamines (for the treatment of allergies) decongestants, gastro-intestinal agents and dermatologicals (to treat skin conditions). Through gaining access to Aspen¶s current portfolio and future pipeline, GSK will be distributing more products and medicines needed by those in low- and middle-income countries. The long-term nature of this collaboration ± initially beyond a 10 ten-year period ± also underlines GSK¶s philosophy of investing in a meaningful and sustainable manner in the developing world. In January 2009 we announced an agreement with UCB S.A. to acquire its current marketed product portfolio across certain territories in Africa, the Middle East, Asia Pacific and Latin America. As a result of the agreement, GSK will acquire several leading pharmaceutical brands in a number of disease areas. These include Keppra for the treatment of epilepsy and Xyzal and Zyrtec for the treatment of allergic rhinitis. The Aspen partnership and the UCB deal sit alongside the recent acquisition of Bristol Myers Squibb¶s mature pharmaceuticals businesses in Egypt and Pakistan and the two associated manufacturing facilities. Together, these deals will provide GSK with access to a renewable, high-quality and competitively priced pipeline of branded pharmaceuticals products that complements its existing portfolio of products, and will help drive patient access in low- and middle-income markets.
GSK vaccine eliminates Hib meningitis as a public concern in Uganda A national, four-year immunisation programme using GSK¶s TritanrixHB Hib vaccine has eliminated Hib meningitis as a public health concern in Uganda, according to the Global Alliance for Vaccines and Immunisations (GAVI) 1. Hib meningitis is a dangerous inflammation of the lining of the brain and spinal cord. GAVI, a public-private partnership that includes the World Health Organization and the World Bank and is supported by the Bill & Melinda Gates Foundation and others, says that the use of TritanrixHB Hib between 2002 and 2006 has reduced the number of incidences of the disease in Ugandan children to zero. The news follows similar results in Bangladesh, Kenya, Chile and the Gambia, as well as Britain and the US, where the vaccine was shown to cut the number of cases of Hib meningitis by at least 88 per cent in a threeto-five year period. Julian Lob-Levyt, Executive Director of GAVI, says the results are extremely positive. ³We can applaud a true success in controlling this deadly disease, which has too often claimed so many lives,´ he says. Though developed countries have largely eliminated the disease, Hib vaccine distribution has been slow in poorer parts of the world due to financial and logistical problems, as well as limited awareness of the disease. In Uganda, the government obtained GAVI support to use 16.5 million doses of 5-in-1 vaccines, giving protection against Hib, diphtheria, pertussis, tetanus and hepatitis B. According to a study published in The Bulletin of the World Health Organization, the vaccination programme in Uganda is now preventing almost 30,000 cases of severe Hib disease and 5,000 child deaths every year. "The introduction of Hib vaccine has completely changed the epidemiology of bacterial meningitis in Uganda," says Adeodata Kekitiinwa, a paediatrician at Kampala's Mulago Hospital, who co-authored the study. Hib kills about 400,000 children under the age of five every year, and is linked to around three million cases of illnesses that can result in long-term effects such as deafness, paralysis, mental retardation and learning disabilities. GAVI says that for every child with Hib meningitis in a developing country, there are thought to be five to ten others with Hib-related pneumonia, which is also preventable by vaccination. 1. GSK press release, March 2008
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Home Responsibility Access to medicines Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders Aren¶t your access programmes just a drop in the ocean, given the scale of the healthcare crisis in the developing world? The global healthcare crisis is extensive and complex, and the programmes of any single organisation are insufficient on their own. Political will and the effective investment of extra resources are required to support healthcare development and build infrastructure. GSK and the wider pharmaceutical industry do not have the mandate, expertise or resources to address the problem alone. Without a global partnership to address the issues, the efforts of any individual stakeholder will be inadequate. Primary responsibility for dealing with the crisis lies with governments, which can call on international agencies and NGOs for support. GSK is committed to playing a full part in partnerships with these organisations and is seeking new ways to make a contribution. We focus our access programmes on specific areas where we think we can make a real difference. For example, we research and develop medicines and vaccines that are particularly needed in developing countries, and make them available at lower prices through preferential pricing arrangements and voluntary licences. We are also working to identify other ways that we can support the strengthening of healthcare systems through expanding our pricing policies, by being more flexible with our intellectual property and by investing in healthcare infrastructure. Why are your medicines so expensive? Wouldn¶t the most responsible thing you could do be to cut the price of your medicines? Improving affordability of our medicines is important and we are taking steps to do more in this area. However, as Kevin de Cock, the Head of HIV/AIDS at the WHO, has said ³If you work in these countries it is very obvious, very quickly, that the elephant in the room is not the current price of drugs. The real obstacle is the fragility of the health systems, particularly in Africa.´ Therefore, unless action is taken to address the underlying problems of poverty and healthcare infrastructure, reducing prices alone will not solve the problem. We have to price our products at a level that enables us to continue to fund R&D and discover the medicines and vaccines of the future. We also need to make enough profit so that GSK remains an attractive prospect for investors. While we want to make a difference, cutting prices too far would mean we undermine the longterm profitability and therefore sustainability of our business. Getting this balance right isn¶t easy. The pricing pilots we have been conducting in recent years have taught us that there are no easy solutions. We believe that the new pricing policies we announced in 2009 will help to improve affordability for the world¶s poorest and we will continue to learn and refine our approach as we roll out these policies. Why are so few people with HIV/AIDS receiving treatment in the developing world? There has been important progress in this area and now over three million people in the developing world are receiving treatment with life-saving anti-retrovirals. This has led to a decline in deaths caused by AIDS despite an increase in the number of people living with HIV. However, there is much more to do. The core issue is that many people in developing countries do not have access to effective healthcare services and are therefore unable to access medicines. Due to poverty, many clinics and patients are unable to pay for even the cheapest basic generic medicines. The access issue is complex and multifaceted. Pricing of medicines is important, but we believe there are many other more significant barriers. Other factors that play a part are inadequate healthcare resources, lack
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of clinics and hospitals, poor distribution networks, low numbers of trained healthcare providers, high levels of patient illiteracy, significant stigma and discrimination, and a lack of political will and inadequate prioritisation of health in government budgets. This is why in 2009 we announced that 20 per cent of the profits we make from selling medicines in least developed countries will be reinvested into projects that strengthen infrastructure and widen access. Why don¶t you just donate your AIDS products to the world¶s poorest? In common with many other stakeholders, including Oxfam and the WHO, we do not believe that donations of ARVs offer a solution to the AIDS pandemic or for healthcare problems in the developing world more generally. This is a widespread crisis and one which requires a long-term commitment to treatment. This commitment cannot be assured through donations. As WHO Director General Margaret Chan has said ³Health systems are the tap root for better health. All the donated drugs in the world won¶t do any good without an infrastructure for their delivery.´ In some limited circumstances donations may be appropriate, for example, in disease elimination efforts such as the Global Alliance to Eliminate LF. We have in the past donated ARVs to support UNICEF Prevention of Mother-to-Child Transmission programmes, and we continue to support collaborative clinical trials to assess the appropriate use of ARVs in resource poor settings. Why doesn¶t GSK extend its not-for-profit prices to middle-income countries? Middle-income countries are not automatically eligible for the not-for-profit prices offered to Least Developed Countries (LDCs) and sub-Saharan Africa. However, they can access medicines at reduced prices. Middleincome countries can secure preferential prices through bilateral discussions with GSK and we are looking at ways to make this process easier. We are focusing our preferential prices on the countries where the need is greatest and resources are most limited. It is widely accepted that in terms of support for improving healthcare services, these are the LDCs (as defined by the UN) and sub-Saharan Africa. We have been conducting pricing pilots in middle-income countries in recent years which have taught us that there are no easy solutions. However, we will continue to develop policies in middle-income countries that are more flexible on price and therefore more closely reflect a country¶s ability to pay. Why don¶t you allow middle-income countries to buy your ARVs from generic manufacturers? We have granted eight voluntary licences for our ARVs to African generic companies. Under these arrangements they can supply a number of middle-income countries in Africa. Middle-income countries are generally more economically developed than the least developed countries and often have a large and affluent middle-class. These countries also have large numbers of people living in extreme poverty and healthcare demands often outstrip available resources. We recognise that many middle-income countries need assistance. However, we believe a different approach is needed from the one we take in the world¶s poorest countries and we will continue to refine our approach during 2009. Our offer to supply products at not-for-profit prices in the world¶s poorest countries is only sustainable if we can continue to make an adequate return on them in wealthier markets. Many middle-income countries are also growing commercial markets for GSK and represent an important source of future business for our industry. Our response in these markets must therefore be one that balances our commercial objectives with our global commitment to work with governments and other stakeholders to ensure that our medicines and vaccines reach as many as possible of those who need them. We believe governments in middle-income countries can improve access by increasing investment in disease prevention and healthcare; eliminating taxation and tariffs on medicines; and creating an environment which allows a strong private healthcare sector to co-exist with public healthcare provision. We are working with governments to find creative ways to meet these goals. Why don¶t pharmaceutical companies work together to increase access to medicines? We are working with the main industry associations on new initiatives to increase R&D and improve access, and we will continue to seek new opportunities to work in collaboration with all stakeholders, including other companies.
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Home Responsibility Research practices
Corporate Responsibility Report 2008 Research practices We are committed to focusing on the patient in everything that we do. Our R&D pipeline is central to our ability to meet patients¶ needs. High ethical standards in R&D are key to protecting participants in our clinical research, ensuring the quality of our research, and maximising the benefits and minimising the risks of our products. High ethical standards are also essential for us to obtain regulatory approval for new medicines, and for patients and doctors to put their trust in our research programmes and products. We aim to make our medicines as safe as possible by evaluating the risks and benefits at every stage from initial research, through to clinical trials and then after a new product is approved for sale. We are committed to high levels of transparency about the results of our clinical research and use a number of reporting channels so that those who evaluate the efficacy and safety of our medicines or use our medicines can make informed decisions on their use. We also recognise that biomedical research can raise ethical concerns including: The use of emerging technologies, such as cloning and the use of stem cells Animal research The storage and use of human tissue The protection of personal information about research participants We participate in discussions on research practices and we regularly engage with academic scientists, regulators, policy makers and other stakeholders on related issues.
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Home Responsibility Research practices Emerging technologies
Corporate Responsibility Report 2008 Emerging technologies Research capabilities are expanding through the development of technologies related to areas of research such as stem cell and genetic research. These advances are helping to expand the boundaries of scientific understanding. These technologies hold out hope for new ways to treat serious diseases as well as better ways to evaluate the risks and benefits of the medicines we develop. For example, advances in genetic research are beginning to enable identification of patients who are more likely to experience a side effect from a medicine. We use emerging technologies in our research and we are involved in collaborative research on these technologies. We recognise that research using these emerging technologies can give rise to ethical concerns. Here we outline our involvement and approach to: The use of cloning technologies The use of stem cells Genetic research Collaborative research on emerging technologies Use of transgenic animals
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Home Responsibility Research practices Emerging technologies Cloning technology and stem cell research
Corporate Responsibility Report 2008 Cloning technologies and stem cell research Cloning technologies GSK uses cloning technologies to replicate molecules and cells for research. These technologies have provided better ways to evaluate compounds, enabling greater insight into the risks and benefits of potential medicines and helping to create better medicines for patients. This technology is a fundamental component of medicine discovery and development. GSK does not clone animals. We do not use cloning technologies with the intention of reproducing entire human beings and we do not see a medical or research case for doing so. Read our position statement on cloning technologies and stem cell research.
Stem cell research We recognise the importance of being clear about our approach to stem cell research and the standards we apply in this area of research. We updated and published our approach to stem cell research in 2008. It sets out the standards we apply when using stem cells, including when using embryonic and foetal stem cells. In 2008, we began a five-year collaboration with the Harvard Stem Cell Institute (HSCI). This includes a $25 million investment to support research at Harvard University and a number of affiliated hospitals in the areas of neuroscience, heart disease, cancer, diabetes, musculoskeletal diseases and obesity. The collaboration is overseen by a joint steering committee made up of HSCI and GSK scientists and managers. We are also a founding member of the Stem Cells for Safer Medicine (SCSM) initiative in the UK. SCSM aims to develop a bank of human cell lines to be used in early medicine discovery. This will provide early identification and elimination of potential toxicity issues before clinical testing. A number of public sector organisations are contributing to the initiative including the Department of Health, the Department for Innovation, Universities and Skills, the Scottish Government, the Medical Research Council and the Biotechnology and Biological Sciences Research Council. An independent ethics review board is being established to review the SCSM ethics policy. Read more about how we are collaborating in research on emerging technologies.
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Home Responsibility Research practices Emerging technologies Genetic research
Corporate Responsibility Report 2008 Genetic research Genetic variation underpins many aspects of human health, such as why some people get certain diseases while others do not, at what age diseases manifest themselves and how fast they progress. In the last year, more genes have been identified for common human diseases than in the cumulative history of genetics research. Diseases for which genetic risk factors have been identified include diabetes, heart disease, obesity, several cancers, asthma and a number of autoimmune disorders. GSK researchers have led or contributed substantially to several of these findings. These discoveries, and others to come, offer promise for the development of innovative new medicines. Individual differences in genes also affect how people respond to medicines. Differences in genes can explain why some patients experience adverse responses to certain medicines while others enjoy benefits without such effects; why some individuals require greater doses of medicines than others to achieve the same level of efficacy; and why some groups of individuals respond well to treatment while others do not. GSK scientists are using emerging genetic information to study how medicines can be differentiated to suit groups of patients with different genetic characteristics. Successful genetics research requires close collaboration between organisations with different areas of expertise. We are engaged in a number of research projects involving academic partners, regulatory agencies and other pharmaceutical companies. Read about our involvement with the Serious Adverse Events Consortium (SAEC) collaboration. We recognise that people have concerns about some of the applications and standards of genetic research. We aim to address these concerns by being transparent about how and why we conduct genetic research. Any genetic analysis during GSK clinical trials is only undertaken after seeking and obtaining informed consent from the patient. This procedure includes providing information on the purpose and scope of the research and who has access to the genetic research data. We believe that the pharmaceutical industry shares responsibility with governments for helping to identify and develop policy on genetic research. We refer to guidance from national and international groups to inform our genetic research activities such as the European Medicines Evaluation Agency, the US Food and Drug Administration and the Council for International Organisations of Medical Sciences.
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Home Responsibility Research practices Emerging technologies Collaborative research on emerging technologies
Corporate Responsibility Report 2008 Collaborative research on emerging technologies New scientific knowledge and technologies can be developed for application to medicine discovery and development through collaborative research that combines resources, expertise and know -how from several partners. The benefit of this research is often realised by making the results widely available to the research community. For example, we are an active participant in the Innovative Medicines Initiative (IMI) a public-private partnership set up by the European Commission and the pharmaceutical industry through the European Federation of Pharmaceutical Industries and Associations (EFPIA). The IMI will support and stimulate collaborative research in Europe involving pharmaceutical companies, smaller bioscience companies, academia, regulators and patient groups with the aim of removing barriers to the discovery and development of new medicines. Read more about our investment in R&D and new technologies. More on our partnerships and academic collaborations.
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Home Responsibility Research practices Animal research
Corporate Responsibility Report 2008 Animal research Approach
Performance & plans
Animal studies remain a small but vital part of our research.They are the only method that can demonstrate the effects of a potential new medicine in a living body before it is used in humans. In addition, research in animals can provide vital information about the causes of diseases and how diseases may develop. Safety regulations require us to test all new medicines on animals before they are tested in clinical trials using humans. Most vaccines have to be tested on animals each time a new batch is produced. Our non-medicinal Consumer Health products or ingredients, for example dietary supplements, are not tested on animals unless there is a specific demand from a regulatory authority or if we determine that a study is needed to support safe use. GSK does not conduct animal testing on our Nutritional Healthcare products or products classified as cosmetics, for example toothpastes marketed in the European Union. When animals are necessary for our research, we are committed to acting ethically, providing for the animals¶ health and wellbeing and practising good animal welfare.
Our approach GSK has animal research laboratories in Europe, Asia and the US. Some animal research is conducted by external contractors on our behalf, representing around six per cent of our total animal use. We estimate that animal research accounts for around five per cent of all GSK research expenditure. Almost all the animals used by GSK are rodents, mainly rats and mice. We also use rabbits, dogs, nonhuman primates, fish, ferrets, chickens, pigs, cats, sheep and goats. Together these account for just over one per cent and are listed in order of magnitude of use. Ultimately GSK would like to see the important benefits of research being achieved and applied to humans without the need for animals in research. We do not believe this can be achieved in the foreseeable future. Our goal is to use animals only when scientifically necessary, use as few as scientifically feasible and to minimise pain and distress. Therefore GSK remains committed to the 3Rs.
The 3Rs A key aspect of animal welfare is covered by what the biomedical community refers to as the three Rs (3Rs). These Rs are: Replacing research using animals with non-animal alternatives or species of the lowest possible order (phylogenetically) Reducing the number of animals used in experiments and still obtaining the same information as in a larger study Refining techniques to minimise pain and distress and maximise the welfare of animals Our scientists always try to devise experiments that do not require any animals. When that is not possible, the researchers will work with others to design an experiment so that we obtain the necessary information from the smallest number of animals possible, with the least effect on individual animals. We implement the 3Rs by using advanced scientific methods, training, raising awareness, and sharing and encouraging best practice. For example, we use ultrasound for imaging heart disease in rats and we have a forum for discussion on global principles for animal housing. Read more on recent GSK advances in replacing, reducing and refining animal use
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In addition we encourage a 3Rs culture at GSK through: Regular training for staff involved in the care and use of animals Review of study designs by an ethical panel which considers the 3Rs and whether alternatives to animal studies are possible prior to the approval of studies Refining techniques to minimise pain and distress and maximise the welfare of animals Our internal 3Rs website which champions advances in refinement, reduction and replacement of animal use in medicine discovery and development, and promotes their application across R&D A news bulletin on advances in the 3Rs which is updated on a rolling basis and is easily accessible from the 3Rs website Our internal Animal Welfare Awards for employees who have made outstanding advances in implementing the 3Rs
Non-human primates Our policy requires that studies involving animals must use the lowest possible order (phylogenetically) of animal appropriate for the research study. Occasionally, non-human primates may be the only animals where the anatomy and/or physiology of a disease is similar to that in humans. Sometimes only human and non-human primates will be affected by or respond to a potential medicine or vaccine; for instance, a new medicine may be based on a molecule produced by primates, including humans, and would be destroyed by the immune systems of other species. We therefore use non-human primates, only if no species of lower neurophysiological sensitivity is appropriate. The two most common non-human primates species used in research are macaques and marmosets. Of the animal research that we carry out, less than 0.5 per cent involves non-human primates.
Transgenic (genetically modified) animals Genetically modified animals, also known as transgenic animals, have been genetically adapted by scientists to create new characteristics. Most transgenic animals (over 95 per cent) used in biomedical research are mice. Transgenic strains of animals are developed to answer specific compound or disease-related questions as part of the medicine discovery process. For example, transgenic mice that model Alzheimer¶s disease have been fundamental in biological research, new compound development and target validation. The use of such transgenic models in mice can sometimes replace the need for studies in higher order animals.
GSK worldwide standards While recognising differences in country-specific regulations, GSK achieves worldwide standards by using core principles for the care of laboratory animals. These principles establish our basis for animal work conducted by or on-behalf of GSK. In addition, all GSK facilities and external laboratories conducting research on our behalf must follow all legal and regulatory requirements. In the UK these regulations are the responsibility of the Home Office. In Europe animal research comes under Directive 86/609/EEC and in the US is covered by the Animal Welfare Act 2006. We also continue to seek voluntary accreditation from recognised agencies such as the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALACi).
Communicating our approach Some people hold strong views on animal research and testing. We believe it is important to explain the need for animal research and testing and to be transparent about what we do. Many of our laboratories host visits from schools, colleges, animal welfare organisations and others. We engage regularly with animal welfare organisations and our investors, as well as contributing to the debate in the media.
Protest We accept the right of lawful protest against animal research as a part of a free society, but condemn the use of violence and intimidation by some who are opposed to animal use. We welcome the shift away from extremism to informed debate.
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Home Responsibility Research practices Animal research
Corporate Responsibility Report 2008 Animal research Approach
Performance & plans
The 3Rs The great apes family comprises gorillas, chimpanzees, orangutans and bonobos. One species of ape, Pan troglodytes, also known as the µcommon chimpanzee¶, has been used in biomedical research for over three decades. The other great apes are not used in biomedical research. In 2008 we took a voluntary decision to no longer carry out research in great apes. Read more in our position statements on the use of non-human primates and great apes in research. As well as the ban on the use of great apes, recent GSK advances in replacing, reducing and refining animal use include: Implementing a polio vaccine test at the bulk manufacturing stage that uses transgenic mice instead of non-human primates. These are mice that have been genetically altered to make them susceptible to the polio virus Decreasing the number of animals needed for vaccine testing. For example, we included an in vitro (nonanimal) test in the regulatory submission for our new vaccine against the Human Papillomavirus, Cervarix. This means that for many markets new batches of Cervarix will not need to be tested in animals Developing a transgenic mouse model that mimics an accelerated form of Alzheimer¶s disease to replace primates as a primary model for this disorder. Fundamental biological research, compound development and target validation have been carried out using this mouse model, facilitating greater understanding of this disorder and the potential for future therapies Implementing new technology to collect blood samples in animal studies. This approach enables analysis to be carried out on much smaller blood samples than traditional techniques. This enables quality data to be obtained using fewer animals Working with governments to change regulatory requirements so fewer animals are required for routine testing. A proposal to reduce animal testing originating from GSK¶s vaccines business was submitted to the European Vaccine Manufacturers Association and later presented to the European Directorate for the Quality of Medicines in 2007 Developing in vitro alternatives to safety tests which check the potential impact of pharmaceutical process materials on workers¶ skin and eyes. No animals have been used in the evaluation of dermal or eye irritation for worker safety purposes since 2006 Donating our collection of information on commonly used blood collection methods to the UK National Centre for the 3Rs (NC3Rs). Our donation was the founding part of the NC3R¶s blood sampling website. This UK site is used by many laboratory staff to choose the most appropriate technique for the humane and efficient sampling of blood Our internal Animal Welfare Award recognises work that is demonstrably above and beyond the very high standards of care, experimental design and implementation expected in GSK from all employees involved in animal experimentation. To receive the Award, the contribution should have tangible benefits in terms of one or more of the 3Rs and should make a difference to how animal experimentation is conducted at GSK or how animals are routinely cared for. Recent recipients of our internal Animal Welfare Award have been:
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A team in UK for implementing blood-spot technology in preclinical toxicokinetic (TK) studies. Using this technology meant researchers needed significantly smaller volumes of blood, which therefore meant fewer animals were needed for TK studies A member of the Neuroscience department for developing and assessing an alternative method of administering medicines to rats. This replaces the previous method that required restraint during dosing and allows us to train rats to drink the test substance directly from a syringe. A team in Italy who developed an innovative nicotine self-administration animal model for pharmacological treatments aimed at smoking cessation. It resulted in a 40-50 per cent reduction in the number of animals needed per study
Number of animals In 2008 the absolute number of animals used in our laboratories was nine per cent lower than in 1994 while R&D activity has tripled in the same period. We estimate that the proportion of total GSK animal research conducted by external contractors was lower in 2008 at 6.2 per cent, compared to 7.9 per cent in 2007. Animals used by GSK in 2008 (per cent)* Mice
71.1
Rats
20.5
Guinea pigs
7.1
Other rodents
0.2
Rabbits
0.4
Others
0.7
*This does not include animals used by external contractors on our behalf. Of the animals used by external contractors on our behalf in 2008, 88.7% were rodents and rabbits. Change in R&D activity compared to change in number of animals used by GSK*
* These data do not include animal research conducted by external contractors on our behalf. R&D activity combines our R&D budget and our vaccine sales, the two main drivers of animal use. We started separately estimating our external animal use in 2002 and to 2008 have recorded external animal use as representing 3.2%, 4.3%, 6.7%, 6.3%, 8.2%, 7.9% and 6.2% of total animal use. The range of external interactions that may involve GSK, directly or indirectly, in animal use is so diverse, and is reported to the regulators by third parties, that we refer to these data as an estimate.
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AAALACi accreditation Our animal laboratories in Belgium, Italy, Spain, the UK and the vast majority of those in the US are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALACi), a private, non-profit organisation that promotes the humane treatment of animals in science through voluntary accreditation and assessment programmes. To achieve AAALACi accreditation, an organisation must go through a rigorous assessment by the association which reviews facilities, workers and animal care. To maintain accreditation annual updates and on-site reviews on a tri-annual basis are required. These site visits are conducted by members of the AAALAC Council and other trained professional staff. This accreditation covers over 90 per cent of the animals housed in GSK-owned laboratories and we are working to extend this accreditation to our other animal facilities.
Our plans GSK is committed to the 3Rs; a current initiative includes a review of animal models across the business. This will look at the types of studies being performed to ensure the most suitable model is being used and that the appropriate numbers of animals are involved. Our R&D leadership team will review outcomes of this analysis and make recommendations for further initiatives in 2009 and beyond.
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Home Responsibility Research practices Human tissue research
Corporate Responsibility Report 2008 Human tissue research Research using human tissue or human biological samples is fundamental to the discovery, development and safety monitoring of GSK medicines. It is vital that this research is conducted in a manner that respects the rights of research participants and meets legal and ethical obligations. The UK Human Tissue Act 2004 makes consent the fundamental legal requirement for the collection, use and storage of human tissue in the UK. This was introduced in 2004 following events at Alder Hey Hospital and Bristol Royal Infirmary where human tissue was taken, used and stored without consent. In 2008, we introduced a policy which applies the principles of the UK Human Tissue Act on a global basis for research conducted, sponsored, supported or funded by GSK. This will ensure that the stringent ethical requirements of the UK law are applied wherever research is conducted using human biological samples.
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Home Responsibility Research practices Medical governance
Corporate Responsibility Report 2008 Medical governance GSK is committed to the highest standards of ethical medical practice. This supports our mission to improve the quality of human life by enabling people to do more, feel better and live longer. Medical governance at GSK is the system of principles, policies and accountabilities that ensures we apply generally recognised principles of good medical science, medical integrity, ethics and standards. It provides a framework to embed the following principles: Patient safety is the fundamental operating principle for GSK ahead of commercial or other interests Our clinical research is conducted in an objective, scientific and ethical manner which protects and informs patients Promotional practices and the information we provide on our products is ethical, accurate and balanced so that our medicines are used appropriately to benefit and minimise the risks for patientss Medical governance across GSK encompasses the principles, policies and accountabilities of three areas:
We have a framework for medical governance across all our businesses and our Chief Medical Officer (the most senior physician at GSK) has responsibility and authority for establishing an effective medical governance system. Our Corporate Executive Team members are responsible for the performance of, and compliance with this system within their areas of responsibility. Our Medical Governance Executive Committee establishes policy for medical governance, subject to approval from the Corporate Executive Team. It also ensures that our medical governance systems are operating effectively. Regional medical directors together with their regional presidents and the country/territory medical directors, ensure our policies and systems for medical governance are understood and complied with in the countries for which they have responsibility. Read about our patient safety governance framework.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Clinical research
Corporate Responsibility Report 2008 Clinical research We carry out a series of clinical trials to evaluate investigational medicines for their potential to become new medicines. The effect of the potential medicine will often be compared against marketed medicines or in some cases an inactive substance (a placebo). Successful clinical trial programmes usually have three or four phases, and safety is evaluated throughout the clinical trials process. We have rigorous procedures and assurance processes to ensure our clinical trials of our medicines are conducted according to the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonisation (ICH) and the principles contained in the World Medical Association Declaration of Helsinki on the µEthical Principles for Medical Research Involving Human Subjects (2008)¶. GSK-sponsored clinical trials are conducted to the same ethical standards irrespective of whether they take place in developed or developing countries. The safety of those who participate in our clinical trials is of paramount importance. Our informed consent procedure ensures that all volunteers are informed of aspects of the trial that are relevant to their decision to participate. All GSK employees involved in conducting trials receive training on regulatory requirements and GSK policies and trials are subject to audit by our internal audit department and regulators.
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Home Responsibility Research practices Clinical research Planning and approval
Corporate Responsibility Report 2008 Planning and approval A protocol is developed for each clinical trial. Protocols set out the purpose of the research and explain how the trial will be conducted and the results analysed ± including details of the dosage and duration of treatment and the number of participants required. The protocol also defines the measurements that will be used to evaluate the safety and efficacy of the medicine, and appropriate procedures should participants wish to withdraw from the study. Trial protocols are reviewed by government regulatory agencies in relevant countries when required. Protocols are reviewed by an independent ethical review committee of lay people, medical professionals and scientists. This committee also reviews and approves the information to be provided in the process of seeking informed consent. Ethics committees have the power to reject or stop a clinical trial.
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Home Responsibility Research practices Clinical research Informed consent
Corporate Responsibility Report 2008 Informed consent Informed consent means that a potential clinical trial participant voluntarily confirms their willingness to participate after being informed of aspects of the trial that are relevant to their decision to participate. It is documented by means of a written, signed and dated informed consent form. Informed consent for a clinical trial involves more than just reading and signing a consent form. There are two essential elements; a process to communicate the information and answer any questions, and signed documentation. The informed consent information is written and communicated in a non-technical style so that a lay person can understand it. It includes a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation and provisions for data protection) and explains participants' rights (including voluntary participation and the right to end participation). Researchers and health professionals know that a written document alone may not ensure that someone understands what participation means. Therefore, the research team discusses with the person the trial's purpose, procedures, risks and potential benefits, and the participants' rights. If the person decides to participate, the team will continue to update them on any new information that may affect their willingness to continue in the trial. Before, during and even after the trial, the person is given opportunities to ask questions and raise concerns. Thus, informed consent is an ongoing and interactive process. There may be special cases where obtaining someone¶s informed consent is not possible such as emergency research scenarios, or when children are below the age of legal consent. In these circumstances consent is sought from someone who is allowed to provide it under local laws and regulations. In situations when someone cannot read but is able to speak and understand the local language, an impartial witness is present during the informed consent process to confirm in writing that the information in the informed consent form was accurately explained and that the potential participant was able to ask questions and gave consent voluntarily.
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Home Responsibility Research practices Clinical research Post-trial treatment
Corporate Responsibility Report 2008 Post-trial treatment In general, we are not responsible for the funding of nationally licensed medicines after a trial, because this is the responsibility of governments and other providers as part of national healthcare systems. However, before beginning trials in diseases or conditions that will continue after the completion of the trial we must be assured that the healthcare system is able to provide, and will take responsibility for, the continued care of patients. In exceptional circumstances nationally licensed medicines may be funded by GSK after the trial so that they can be made available to trial participants who derived a measurable medical benefit. We will continue to fund the medicine until it is funded through the normal healthcare infrastructure or the patient no longer derives a medical benefit. There may be circumstances when there is a compelling medical rationale for patients to continue to receive an investigational medicine after the clinical trial. In this case, post-trial treatment may be provided in a clinical trial or through expanded access programmes which enable appropriate oversight and reporting of adverse events. In these circumstances, GSK will fund the investigational medicine for as long as the patient benefits from it or until the compound is approved and licensed in that country. Read more in our public policy on Clinical trials in the developing world
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Home Responsibility Research practices Clinical research Clinical trials in the developing world
Corporate Responsibility Report 2008 Clinical trials in the developing world All GSK clinical trials, wherever they are carried out, are conducted to the same high standard. GSK does not conduct clinical trials in countries when we know at the outset that there is no intent to pursue registration and make the product available for use in that country. Additional steps may be needed to ensure that trials in some of the least developed countries are conducted according to the Good Clinical Practice (GCP) guidelines. For example, matching the objectives of informed consent to local culture may be necessary, for instance by involving local leaders and/or family members. In some circumstances capacity may be provided to help develop a certain skill or competence, or for general upgrading of performance ability, which will facilitate the prospective conduct of clinical research activity not only for GSK but also the broader community. Read more about post-trial treatment. Read our position statement on clinical trials in the developing world.
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Home Responsibility Research practices Public disclosure of clinical research
Corporate Responsibility Report 2008 Public disclosure of clinical research Approach
Performance and plans
Pharmaceutical companies are legally required to disclose all relevant data from clinical trials to the appropriate regulatory authorities when seeking approval for a new medicine. After approval, sponsors have a continuing obligation to provide regulatory authorities with updated safety information from clinical trials. Read more about patient safety Safety and efficacy information is provided to doctors through prescribing information which is approved by regulators. Public disclosure of our research is fundamental to advancing medical science and informing prescribers and patients about scientific findings relating to our medicines. Our Clinical Trial Register was launched in 2004 and is designed to supplement prescribing information and publications in the scientific literature. It contains data relating to marketed medicines and serves as a resource for researchers, medical professionals and the public to use alongside locally approved prescribing information. An improved Clinical Study Register, launched in 2008, has replaced the previous Register and now also includes protocol summaries and enhanced searching capabilities. Read a case study on how the new register is helping to improve access to clinical trials information. Read our position statement on disclosure of clinical trial information
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Home Responsibility Research practices Public disclosure of clinical research
Corporate Responsibility Report 2008 Public disclosure of clinical research Approach
Performance and plans
At the end of 2008 there were protocol summaries of all GSK actively recruiting clinical trials on ClinicalTrials.gov, 180 in total. This is a registry of clinical trials conducted around the world and provides information about a trial's purpose, who may participate, locations and contact details for more information. At the end of 2008 there were 3,273 clinical trial summaries on our Clinical Study Register. This includes clinical trials of our major marketed products which have been completed since the formation of GSK in 2000, or that were completed before this and are likely to inform medical judgement. Our objective is to disclose the trial results summaries for all new products on our Register within 12 months of the product reaching the market. We aim to disclose the results of trials completed after a product is approved for marketing within one year of trial completion. We met this objective in 2008. Update August 2009
An internal audit has subsequently shown that during 2008 the results of a small number of trials were not posted to the Register within 12 months of the product reaching the market. Following the audit the results of these studies were posted to the Register in July :HDUHLPSURYLQJRXUSURFHGXUHV for collecting and posting of trial results and expect to meet the objective for 2009 In 2008, a new Clinical Study Register replaced the previous Register and now also provides protocol summaries and enhanced search capabilities to users. Number of summaries of GSK clinical trials on the GSK Clinical Study Register (cumulative total)
Important steps to build on GSK¶s commitment to the transparency of our clinical research were taken in 2008. We have committed from January 2009 to: Posting information about other types of GSK¶s clinical research that evaluates our medicines on the GSK Clinical Study Register. We are adding GSK¶s observational research, meta-analyses and studies of terminated compounds to our current commitment of posting information related to all our clinical trials (phase l-lV) of marketed medicines. In addition we are adding the names of investigators who participate in
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our clinical research Ensuring that all our clinical research is either published as manuscripts in peer reviewed journals or, when studies are not published, providing context and interpretation via the GSK Clinical Study Register to supplement the result summary which is posted This will ensure our studies are made publicly available irrespective of whether the results are perceived to be positive or negative for our medicines. Our progress in meeting this commitment can be monitored by external audiences, as the GSK Clinical Study Register will include protocols or plans for our research as studies are initiated, and summaries of the results and references to publications following completion.
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Home Responsibility Research practices Patient safety
Corporate Responsibility Report 2008 Patient safety Ensuring the safety of our medicines and medical devices is critically important for the health and wellbeing of patients and the success of our business. All medicines have potential risks as well as benefits, although not everyone who takes a medicine will experience side effects. It is important that we identify, evaluate and minimise safety concerns to ensure that the overall benefits of a medicine outweigh any risks. We strive to serve patient interest by promptly detecting potential safety issues with our products and communicating with regulators so that appropriate decisions can be made and actions taken. Product safety is assessed in clinical trials before a product can be approved for marketing. Sometimes adverse events (potential safety issues) occur after approval when a product is being used by large numbers of patients. We have policies and a governance framework in place to help us detect and act on any adverse events. We have a dedicated team of scientists and healthcare professionals across the world which monitors and communicates safety issues to regulatory authorities. We are also investing in genetic research to help predict how individual patients respond to a medicine. In the future this will help healthcare providers prescribe safer and more effective medicines. Read about our patient safety governance framework and how we collect and report safety data.
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Home Responsibility Research practices Patient safety Patient safety governance framework
Corporate Responsibility Report 2008 Patient safety governance framework We have a Global Safety Board (GSB) which makes decisions on product safety issues. The Board is led by the Chief Medical Officer and composed of senior physicians and scientists. Its role is to: Oversee the safety of all investigational and marketed medicines Approve the first administration of investigational medicines to humans Define the doses and duration of treatments that are considered safe Approve the progression of investigational medicines into pivotal trials (these are trials which provide the primary data on which regulatory approval is based) Assess any issues related to patient safety that arise during product development or marketing Three of our central departments are responsible for recording, investigating and evaluating adverse events and reporting them to the relevant regulatory authorities, for example the US Food and Drug Administration (FDA) or the European Medicines Evaluation Agency (EMEA): Global Clinical Safety and Pharmacovigilance team (GCSP), part of GSK Research & Development, responsible for the safety evaluation of all our pharmaceuticals and devices GSK Biologicals Clinical Safety and Pharmacovigilance department, part of our vaccines business, responsible for the safety evaluation of GSK vaccines Consumer Healthcare Product Safety group, part of our consumer healthcare business, responsible for the safety evaluation of consumer healthcare products We require that all GSK staff immediately report any issues relating to the safety or quality of our medicines. Read more about our expectations in our Employee Guide for Business Conduct. Read about our medical governance. Benefit-risk management
We assess the balance between the benefits and risks of a particular medicine throughout its lifecycle ± from early development, during clinical trials, and once the product is on the market. We evaluate and document all available safety information to build a detailed benefit-risk profile of each product. We use this information to develop a benefit-risk management plan, which identifies ways to improve a product¶s benefits and minimise any risks. We review and update plans regularly during clinical development and for a period after a product is approved for marketing.
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Home Responsibility Research practices Patient safety Collecting and reporting safety data
Corporate Responsibility Report 2008 Collecting and reporting safety data We receive information on adverse events from several sources, including: Unsolicited reports from health professionals and patients Post-marketing trials or observational studies Investigators who submit clinical study reports Regulatory authorities Medical and scientific literature Newspapers and other media Each GSK employee is responsible for reporting any adverse event they become aware of. Any adverse events that occur are recorded on our global safety database and clinical trial database and are investigated by our clinical and pharmacovigilance teams. We report potential safety issues to regulatory authorities on a regular basis. Each country manager is responsible for ensuring the collection of safety information and reporting this to the relevant central safety department and to the local regulatory authority. During 2008, as part of our 2008 Management Certification process, over 14,000 managers acknowledged their compliance with our policy on Adverse Event Reporting which specifies that each GSK employee is responsible for reporting any adverse event they become aware of during the conduct of their work. We have added an Adverse Event Reporting button to the front page of myGSK, our intranet site, to make it easier for employees to report any adverse event they may learn about. Regulators in some countries are also publishing information on adverse events on the internet. For example, data for products marketed in the UK are available via the Medicines and Healthcare products Regulatory Agency. Some safety data are also available in Canada, while in the US the Food and Drug Administration has made the information in its database more accessible to the public by publishing a quarterly report of potential safety issues that it is investigating further. In 2008, research on our diabetes product Avandia continued and a new, FDA required, cardiovascular outcome study was designed and will be initiated in 2009. There was also a combined FDA Advisory Committee review of respiratory products containing long-acting beta2 agonists. Read more on the questions raised about Avandia. Read more on questions about the safety of our products containing long-acting beta2 agonists. Read about our medical governance. Read our position statement on Pharmacovigilance Responding to adverse events
Adverse events affect the benefit-risk profile of a product and corrective actions may be needed to minimise the risk. This can include carrying out further clinical trials, modifying the prescribing information, communications to physicians and other healthcare providers or establishing specific methods to minimise risk. Some products are subject to limited distribution programmes, for prescription
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by specialist doctors only. In certain cases it may be appropriate to stop a clinical trial or withdraw a product from the market. Our global labelling committees review and approve the prescribing information for all our products and ensure this is updated when appropriate.
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Home Responsibility Research practices Patient safety Collecting and reporting safety data Responding to questions about Avandia
Corporate Responsibility Report 2008 Responding to questions about Avandia Avandia is our leading treatment for type 2 diabetes. In 2007, a meta-analysis published in the New England Journal of Medicine 1 and GSK¶s own meta-analysis 2 (submitted to the FDA and other regulators in 2006) were at the centre of a debate on whether Avandia may be associated with an increased risk of myocardial infarction and death from cardiovascular causes. Following an FDA Advisory Committee meeting, the FDA approved updated prescribing information for Avandia, including new text in the existing boxed warning, in November 2007. This updated prescribing information summarised data from an FDA meta-analysis of myocardial ischemic events that suggested a risk associated with Avandia, and from three long-term clinical trials 3 comparing Avandia against both placebo and other oral anti-diabetes medicines that did not confirm or exclude the risk. This revised prescribing information included that µin their entirety, the available data on the risk of myocardial ischemia are inconclusive¶. In 2008, research involving Avandia continued, including the cardiovascular outcome study called RECORD, for which results will be available in 2009. In addition, GSK worked to design an FDA-required cardiovascular outcome study of Avandia, to be called the TIDE study, to begin in 2009. Update August 2009
Results of the cardiovascular outcome study RECORD wereSXEOLVKHGLQ-XQH 5(&25'ZDVD large, prospective, randomized, controlled study that was initiated in 2001, and designed to compare cardiovascular outcomes of patients on Avandia added to metformin or sulfonylurea to those on metformin and sulfonylurea. The study showed that the combined endpoint of cardiovascular hospitalization or cardiovascular death (which includes heart attack, congestive heart failure and stroke) was not statistically different between the two groups after an average of 5.5 years of therapy. 4 The TIDE study has started in 2009 as planned. All medicines, Avandia included, carry risks as well as benefits. Because type 2 diabetes is chronic, relentlessly progressive and a life-threatening disease, and because physicians often need to prescribe two or three medicines to help their patients maintain their blood sugar levels, having an array of treatment options is important. GSK believes it is important that Avandia is available to support effective treatment of type 2 diabetes. 1. S. Nissen & K. Wolski, Effect of Rosiglitazone on the Risk or Myocardial Infarction and Death from Cardiovascular Causes, N. Engl. J. Med. 2007; 356: 2457-71 2. A. Cobitz, et al, A retrospective evaluation of congestive heart failure and myocardial ischemia events in 14237 patients with type 2 diabetes mellitus enrolled in 42 short-term, double-blind, randomized clinical studies with rosiglitazone, Pharmacoepidemiology and Drug Safety, 2008; 17: 769±781 3. i) P. Home, et al, Rosiglitazone Evaluated for Cardiovascular Outcomes - An Interim Analysis, N. Engl. J. Med. 2007; 357: 28-38; ii) S. Kahn, et al, Glycemic Durability of Rosiglitazone, Metformin, or Glyburide Monotherapy, N. Engl. J. Med. 2006; 355: 2427-43; iii) The DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators, Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial, Lancet, 2006; 368: 1096-105.]
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3+RPHHWDO5RVLJOLWD]RQH(YDOXDWHGIRU Cardiovascular Outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial, Lancet, 2009, 373: 2125-2135.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Patient safety Collecting and reporting safety data Questions about the safety of our products containing long acting beta2 agonists
Corporate Responsibility Report 2008 Questions about the safety of our products containing long-acting beta2 agonists Long-acting beta2 agonists, known as LABAs, are daily controller medicines that relieve and help prevent airway constriction. Airway constriction is one of the two main components of asthma. LABAs do not treat the other main component of asthma ± inflammation. This can be treated by another type of daily controller medicine called an inhaled corticosteroid (ICS). LABAs, including GSK¶s product Serevent, should not be used alone in the treatment of persistent asthma. Leading treatment guidelines recommend that LABAs be used for appropriate patients with asthma only in combination with an ICS. GSK makes two products containing the LABA salmeterol. Seretide/Advair is a combination of salmeterol and the ICS fluticasone, while Serevent contains salmeterol alone. In December 2008 a combined Advisory Committee to the US Food and Drug Administration reviewed the benefit-risk profile of medicines containing LABAs in children and adults with asthma. This review included all LABA-containing products indicated for use in treating asthma, not just GSK¶s products, and addressed lingering concerns that LABAs may increase the risk of asthma-related death, as current product labels prominently warn. The Advisory Committee makes recommendations to the FDA, which then makes the final decision on any actions required. For Seretide/Advair, the Committee unanimously voted that the benefits of Seretide/Advair outweigh the risks for patients 18 years and older. The Committee also voted in favour of a positive benefit-risk profile in younger patients, although the individual votes were mixed. For Serevent, the Committee found that the benefits do not outweigh the risks for the treatment of asthma. Concerns were expressed about the potential for Serevent to be used alone in the treatment of asthma, contrary to the current prescribing information, in a way that would make the benefit-risk profile unfavourable. In contrast, Seretide/Advair is a combination therapy of a LABA and an ICS, so combination use is assured. Although GSK acknowledges concerns that use of Serevent without an ICS is not in the best interests of asthma patients, we favour the option of allowing dual therapy using separate inhalers. Use of separate inhalers is an important treatment option for asthma patients who need an alternative ICS to fluticasone (the ICS contained in Seretide/Advair), or the flexibility of ICS doses beyond those available in a combination product. It is also important for asthma patients who receive more favourable reimbursement for separate inhalers. GSK believes that with appropriate labelling and proactive communication of the risks of using a LABA alone, the potential for misuse of Serevent as monotherapy can be acceptably reduced so that dual therapy using separate inhalers remains available for asthma patients who need it. In September 2008, before the Advisory Committee meeting, GSK submitted a proposed label change to the FDA for Serevent to clarify that use in asthma patients must be in combination with ICS, in line with prescribing information in all countries in which Serevent is marketed. We are awaiting the outcome of the FDA¶s consideration of GSK¶s proposed label change, and of the Advisory Committee¶s review. We will actively cooperate with the agency in reaching an appropriate resolution in the best interests of asthma patients.
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Home Responsibility Research practices Patient safety Performance
Corporate Responsibility Report 2008 Performance We have continued to improve our patient safety systems, safety databases and monitoring processes. Examples from 2008 include: Established two more Clinical Toxicities Strategy Panels (comprising internal and external experts) to provide expert safety input throughout the medicine development process. We now have expert panels in four areas: cardiovascular, hepatic, renal and haematological Implemented a clinical trials signal detection (CTSD) tool for review of completed study data, in partnership with Lincoln Technologies. This has enhanced our ability to identify and explore safety signals in our clinical trials. The system won a BIO IT award Launched a prototype for our Molecular Clinical Safety Programme (MCSP). MCSP is a tool that seeks to better inform decision-making in medicine development by integrating chemistry, pre-clinical and human safety data and enabling us to look for patterns across the different types of safety information. In October 2008 the GSK team won the Wall Street Journal Technology Innovation Award for Healthcare IT for developing this system. The entry was selected by an independent panel of judges, who reviewed more than 700 applications for the awards
Working with others We work with government officials, industry partners and policy makers in efforts to build an enhanced safety system. For example GSK is the industry lead in the benefit-risk project consortium of the European Commission¶s public-private partnership, the Innovative Medicines Initiative, which aims to develop methodologies to enhance the assessment of the benefit-risk profile of new medicines. GSK is a key partner among the US Food and Drug Administration, other pharmaceutical companies and academia in the US to explore the development of a new system for the detection of adverse events and benefits of medicines using large healthcare system databases. Read about our collaborative research on emerging technologies.
Serious Adverse Events Consortium In 2007, we co-founded the Serious Adverse Events Consortium (SAEC), a collaboration involving more than 20 partners. The SAEC is working to improve patient safety by identifying genetic variants that predict adverse events such as drug-induced liver injury and a rare but serious severe skin rash called Stevens Johnson Syndrome. GSK scientists co-chair the SAEC scientific management committee and have a seat on the board of directors.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Maintaining the confidentiality of research participants
Corporate Responsibility Report 2008 Maintaining the confidentiality of research participants It is vital that medical information collected during research is protected to maintain the confidentiality of participants. We have rigorous procedures to control the use of research data. Our research activities are conducted according to fundamental ethical and legal principles, including consent and ethics committee approval. We use a variety of procedures to protect the confidentiality of research participants¶ data, including data coding, data encryption and restricted access to research databases. Third parties handling research data on our behalf are required to comply with relevant data protection legislation and standards. We only collect information about individuals that is relevant to the research study. This includes medical information such as health status, medical conditions (including, on occasions, genetic data), treatment of conditions and ethnic origin. This means that, in the vast majority of instances, we do not collect or store information that can directly identify individuals such as initials, names, addresses or personal ID numbers. Information that can identify individuals is only used in very specific instances required by law and regulations such as safety monitoring and pharmacovigilance. We retain medical research data using the minimum amount of identifying information and only for the duration reasonably necessary to meet regulatory, legal or research needs.
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Home Responsibility Research practices Working with healthcare professionals
Corporate Responsibility Report 2008 Working with healthcare professionals Our policies governing interactions between GSK R&D staff and healthcare practitioners require that:
All clinical trial investigators must be selected solely on their qualifications to conduct good quality clinical research. Their history of using or not using GSK products must not be taken into account when deciding whether to include or exclude them in a particular trial
Payments to practitioners are governed by contracts and any compensation reflects fair market value for the work performed
No payments are offered or made to influence their judgement on whether to enrol or maintain a participant in a clinical study
Gifts to healthcare professionals involved in research projects for GSK are not permitted.
From 2009, the PhRMA Code on Interactions with Healthcare Professionals also prohibits non-educational gifts to healthcare professionals involved in research. GSK policies have prohibited these gifts to healthcare professionals involved in research since 2006. We are also committing to disclose research payments made to healthcare professionals and institutions. This will start with payments to US healthcare professionals and institutions for conduct of clinical trials starting in 2010. Thereafter it will be extended to payments for other types of research and to healthcare professionals and institutions outside the US. Read more about our policies and monitoring systems that govern our relationships with healthcare professionals.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Training and auditing
Corporate Responsibility Report 2008 Training and auditing Approach
Performance
Training for clinical trials All employees involved in designing, conducting, recording and reporting GSK-sponsored clinical research studies are trained in the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonisation (ICH). Employees must have completed the required training before undertaking these roles. We keep detailed training records which are routinely requested by regulatory authorities when undertaking an inspection of GSK clinical research trials.
Auditing for clinical trials GSK¶s internal audit department audits the conduct of clinical trials. Audits cover GSK systems and processes, as well as external clinical research organisations and investigators performing clinical research on our behalf. Trials are selected for audit based on risk. Risk factors include the complexity of the study, the patient population, the location of the study, previous audit history and any unusual findings during the conduct of the study. Results are reported quarterly to the R&D Compliance Board, and annually to the Risk Oversight and Compliance Council and the Audit Committee of GSK¶s Board of Directors. Read more about these in the corporate governance section of our Annual Report. Members of our Global Safety Board (GSB) receive individual audit reports on any safety-related findings. Any concerns or issues identified are fully investigated and appropriate corrective action taken. For GSK staff corrective actions may include development of new training programmes or retraining for the individuals concerned. In more severe cases appropriate disciplinary action will be taken, up to and including dismissal. For external investigators, GSK may retrain the investigator, or stop working with the investigator. Trial data from noncompliant investigative sites is excluded from the analysis. Regulatory authorities also carry out inspections of GSK and the investigators we use to conduct clinical trials.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Training and auditing
Corporate Responsibility Report 2008 Training and auditing Approach
Performance
Training for clinical trials In 2008 there were 66,579 training activities related to Good Clinical Practice (GCP). Each µtraining activity¶ represents a successful completion of an e-learning module or instructor-led course related to GCP by one of our employees or contractors.
Auditing for clinical trials In 2008 we conducted 208 audits. These included: 150 audits of investigator sites conducting GSK-sponsored trials. This represents approximately five per cent of investigator sites participating in pivotal clinical trials 16 audits of internal GSK systems and processes used in managing clinical trials and data 30 audits of clinical research organisations carrying out clinical trials on GSK¶s behalf 12 audits of GSK local operating companies involved in clinical research activities. WIn addition, 24 investigations were conducted in response to suspected irregularities at investigator sites. Issues identified at investigator sites included insufficient oversight of clinical trial activities by investigators. Oversight covers all areas of investigator responsibility including: knowledge of the protocol design; appropriate and documented delegation of tasks to skilled personnel; and availability to meet sponsor representatives at regular intervals during the study. Additional training for investigators and implementation of further internal controls are helping to reduce the frequency and significance of this issue. Inspections of investigators, clinical research organisations, independent ethics committees/Institutional Review Boards and sponsors of clinical trials are also carried out by regulatory authorities to ensure the safety of trial participants, the quality of data and that trials are conducted according to Good Clinical Practice. During 2008 there were more than 40 such inspections of GSK and investigators used by GSK to conduct clinical trials. The Food and Drug Administration (FDA) conducted a routine Post Marketing Adverse Drug Experience Inspection in 2007. The inspection involved a review of GSK¶s processes for receiving, capturing and tracking adverse drug experience information for GSK products, as well as reporting these data to the FDA. In the course of the inspection, the inspector focused on GSK¶s compliance with regulatory requirements for New Drug Application (NDA) Annual Reports and periodic adverse drug experience reports. As a result of the inspection GSK received a warning letter from the agency in March 2008. The FDA determined that for some products, certain required reports submitted by GSK had not included all required information about clinical studies on a timely basis. The FDA letter acknowledges that information not captured in the periodic reports was, in many cases, submitted to the Agency in other reports and communications. In addition, information about the start of clinical trials that was omitted from some reports was available at www.clinicaltrials.gov. Clinical trial results also are posted publicly to GSK¶s Clinical Study Register. We acknowledge the seriousness of the issues raised in the warning letter, and corrective steps have been taken or are underway to make sure periodic reports are filed completely and promptly. After the inspection, GSK initiated a review of all applicable processes and reporting systems. We have made and will continue progress in updating procedures and improving compliance in the area of reporting, including additional
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
training to ensure that all procedures are followed across all product lines. GSK works continuously to monitor and, as necessary, enhance its compliance systems and procedures.
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Home Responsibility Research practices Case studies
Corporate Responsibility Report 2008 Case studies Focus on the Patient programme Our Focus on the Patient programme helps our R&D employees understand patient needs and inspires them to do more to help improve the lives of patients. In 2008 we held 12 seminars where patients visited GSK sites to help our R&D employees understand the realities of living with their illness. The seminars included discussions on breast cancer, cystic fibrosis, HIV/AIDS, inflammatory bowel disease, schizophrenia, epilepsy, meningitis, hepatitis C, pulmonary hypertension, idiopathic pulmonary fibrosis and migraine headaches. There were over 4,640 attendees at these seminars. We have also held lunchtime sessions to develop ideas and actions. One session prompted the organisation of a seminar at our site in Verona, Italy, providing insight for local scientists developing medicines for sleep disorders and depression. Another idea led to µPatient Empowered¶, a project to improve patients¶ experience in GSK clinical trials, through patient-focused study design and simplified patient-directed communications. To inform our employees about the patients they are helping through their work in R&D, regular monthly bulletins highlight key medicines in our pipeline and how they will meet the needs of patients. This helps to motivate employees by reminding them about the importance of their work. A survey of R&D employees showed over 50% of respondents felt that there was an increase in patient focus across the businesses through greater application of patient focus in work processes and the development of medicines.
Clinical Study Register It is important that the results of all studies that evaluate medicines are in the public domain. This enables the information to be used to help inform medical judgement and advance medical science. Traditionally, publication in scientific and medical journals has been sought but there are well recognised limitations: Have all studies been published by researchers? What if it is not possible to publish a study in a peer reviewed journal? Posting a summary of each study on the internet when it is initiated enables all studies to be tracked to publication. Studies that are not publicly disclosed can be identified and researchers called to account. Posting the results after the study is completed means that results are in the public domain, whether or not the study is accepted for publication. GSK provides an online Clinical Study Register, which now contains the results of over 3,000 trials, covering over 100 GSK products dating back to 2000 when the company was formed. Launched in 2004, we are pleased that the site has been a success and our latest figures show that the site is receiving over 25,000 visitors a month. In 2008 we took further steps to build on our commitment to the transparency of clinical research: To help people quickly find the information they need, we launched a revised version of the Clinical Study Register, which includes an improved user interface making it easier for users to find information by disease area or medicine We are adding observational research and meta-analyses that evaluate our medicines and studies of
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
terminated compounds to the Register. This adds to our current commitment to post-protocol summaries and summary results of all GSK¶s clinical trials (phases l-lV) for our marketed medicines However, the disclosure of research protocols and results online should be seen as a supplement and not a replacement for the need to publish studies in peer reviewed journals. We believe that the level of public disclosure achieved through posting results on our Register alone is below that achieved through papers published in peer reviewed journals which more fully explain a study and places the results in context. GSK aims to publish our clinical research of our medicines as more comprehensive papers in peer reviewed journals. When studies are not published we will provide context and interpretation via our register.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders. How are you assured that the risks for healthy volunteers who take experimental medicines for the first time are minimised? Before a clinical trial can take place, a new compound must undergo a series of stringent laboratory tests. These tests involve the use of animals and human tissue to predict the effects of an investigational medicine in the human body, including any potential side effects. On the basis of the predictions we establish dosing levels with a sufficient margin of safety and/or appropriate monitoring procedures. The µpre-clinical¶ data from laboratory tests, and our proposal for the design of each µfirst time in human¶ clinical trial, are reviewed by a GSK committee, known as the Global Safety Board, of experienced senior physicians and other experts who are independent of the project team. Regulatory authorities and independent ethics committees must approve the trial before it can go ahead. Clinical trials are designed to minimise risk. For example, we initially give volunteers a very low dose of the investigational medicine and increase dosing gradually, carefully sequenced among subgroups, to be cautious in our approach. Trials of an investigational medicine being tested in humans for the first time are conducted in clinical units with rapid access to hospital emergency care. All clinical trial volunteers are provided with information about the study, including potential risks, and have the opportunity to discuss these risks with researchers before deciding whether or not to participate. This is known as informed consent. You plan to enter in to more research collaborations. How will you ensure that the organisations you partner with meet your research and animal welfare standards? We recognise that working in collaboration with other organisations brings certain risks. We are developing routine safeguards to ensure our partners work according to the same core principles as GSK, including those that govern our use of animals in research. These checks will be applied when we are evaluating whether to enter into collaboration, and subsequently on an ongoing basis within the framework established to govern a collaboration, typically a Joint Steering Committee. GSK¶s willingness to enter or continue a collaboration depends on having adequate assurance of a shared commitment to core principles. GSK is opening an R&D facility in China. Will this affect your research standards? Is it a cost reduction exercise? We have opened a new R&D facility in China which is focusing on R&D into neurodegenerative disorders, for which better therapies are desperately needed: Alzheimer¶s disease, Parkinson¶s disease and multiple sclerosis. The costs of conducting research in China are currently relativity lower than those in other markets. However, lower costs are not the reason behind the decision to set up this new facility. The new centre enables us to benefit from accessing the vast talent pool and knowledge in life sciences in China, and to increase focus and depth in important disease areas. Our R&D in China is conducted in accordance with GSK¶s global quality and ethical standards. All R&D policies and monitoring procedures apply to our operations in China. We have committed significant regional and local resource to ensuring our operations in China comply with both Chinese government requirements and GSK¶s global standards.
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Home Responsibility Ethical conduct
Corporate Responsibility Report 2008 Ethical conduct We are committed to creating a strong ethical culture at GSK. We do this by putting the appropriate policies in place, recruiting the right people and equipping them with tools to make ethical decisions. Putting patients first is the core principle of being an ethical pharmaceutical company. Profit without principle is short lived. Failure to uphold high standards of ethical conduct carries significant business risk: Erosion of trust in GSK and our products including among regulators, doctors and patients Fines and litigation resulting in serious financial or legal consequences Damage to GSK¶s reputation Our Code of Conduct sets out fundamental standards for all employees. The Employee Guide to Business Conduct builds on the Code and explains what employees must do to meet its requirements. It provides guidance, including specific examples, on what constitutes unethical behaviour. Strong policies, codes of practice and good training are essential elements of our approach. However, on their own they cannot guarantee that our employees will meet our standards. Our internal compliance systems are designed to identify and address breaches of our codes. We fully investigate suspected breaches and take appropriate disciplinary action, including dismissal where appropriate. We have clear policies and procedures to prevent corrupt and anti-competitive behaviour. Maintaining high ethical standards in our marketing is also vital and is relevant to patient safety. It is essential that our marketing practices help doctors to prescribe medicines that are in the patient¶s best interests. Our policies prohibit kickbacks, bribery or other inducements to doctors, and any promotion for unapproved uses of our medicines. Maintaining high ethical standards during all stages of R&D and once a product is approved for marketing is a key part of our commitment to put the patient first. Your ethical compass
Our Employee Guide to Business Conduct includes an µethical compass¶ that helps employees deal with ethical issues that are difficult to resolve. When faced with such a situation, we encourage our people to ask themselves these questions: Is it legal and ethical? Is it consistent with GSK policy and the Code of Conduct? Is it consistent with GSK¶s Mission and Spirit? Can I explain it to my family and friends? Would I be comfortable if it appeared in a newspaper? We encourage employees to seek additional guidance and to keep asking questions until they are certain that they are making the right choice.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Ethical conduct Code of conduct and business ethics
Corporate Responsibility Report 2008 Code of Conduct and business ethics Code of Conduct The GSK Code of Conduct sets out the standards we expect from our employees and contractors. It contains the following key requirements: Conduct business with honesty and integrity and in a professional manner that protects GSK ¶s good public image and reputation Build relationships with customers, vendors, suppliers and fellow employees based on trust and treat each of these individuals with respect and dignity when conducting business Become familiar with and comply with legal requirements and GSK policy and procedures Avoid any activities that could involve or lead to involvement in any unlawful practice or harm to GSK¶s reputation or image Avoid actual or potential conflicts of interest with GSK, or the appearance thereof, in all transactions Read the full Code of Conduct. Our Employee Guide to Business Conduct builds on the Code and explains what employees must do to meet its requirements.
Business ethics Corrupt and anti-competitive behaviour undermines fair competition, inhibits economic development and is bad for economies, business and people. Our Employee Guide to Business Conduct contains the policies and guidance to ensure that we operate within the letter and spirit of the law and maintain high standards of ethical business behaviour. Anti-competitive behaviour We are committed to free and open competition. We succeed as a company because of the high quality and competitiveness of our products and the talent and commitment of our employees. Our policy on anti-competitive behaviour covers issues such as mergers, abuse of monopoly powers, resale price maintenance, predatory pricing and other restrictive agreements and practices. It sets out the standards of behaviour we expect from our employees and agents. Preventing corruption Our policy on anti-corruption forbids payments or inducements to political candidates, legislators, political parties and party officials, or government officials or employees, whether local or national, including officials and employees of government-owned enterprises and of public international organisations. We also have separate policies on political contributions or donations and on acceptance of gifts or entertainment by our employees. Sample questions from our Employee Guide to Business Conduct
Question: We have received an order for an unusual volume and combination of pharmaceuticals from a new customer in a location noted for political instability. The shipment location is in another country, and the customer has said we should not bother including the usual consumer use information. Is this a problem?
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Answer: There are enough red flags here that you need to get advice from the GSK Legal Department. The information you have indicates that this material might be shipped to a prohibited country or used for improper or even terrorist activity. You need to know your customer and get advice on what to do. Question: A vendor offers to sell a GSK product manager a mailing list of 10,000 names of individuals who are being treated for depression. Are there any concerns with the purchase of such a list? Answer: Yes. Many countries, including the US and those in the EU, have established strict laws protecting healthcare information that identifies an individual. Written authorisation by each individual is usually required for GSK to receive this information.
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Home Responsibility Ethical conduct Marketing ethics
Corporate Responsibility Report 2008 Marketing ethics We market our prescription medicines and vaccines to doctors, hospitals and governments. In some countries, such as the US, we also advertise medicines directly to consumers. Our specialist sales representatives meet regularly with doctors and pharmacists to inform them about our medicines and their approved uses. We believe that sales representatives play an important role in providing up-to-date information to doctors on our products and their benefits and risks to patients. However, we recognise that the marketing of pharmaceutical products raises some challenging issues. In particular, some people are concerned that marketing by pharmaceutical companies exerts undue influence on doctors, that sales representatives do not always give doctors full information about potential side-effects, or that promotion of unapproved uses of medicines may be occurring. Our regional marketing codes forbid these practices and other unethical conduct. We provide regular training so that our sales teams understand these codes and we conduct monitoring to assess compliance.
Marketing Codes of Practice The sale and promotion of pharmaceutical products is highly regulated by governments and medical agencies. We have developed marketing codes and policies and provide training for sales representatives to ensure that they understand how to behave ethically and comply with the law. In many countries our codes and policies go beyond legal requirements. Our products are sold in more than 150 countries around the world. The first priority with any product in any country is patient safety. We have systems and processes to collect, analyse and report safety concerns about our products. Our marketing codes of practice apply to all employees and agents. They commit us to promotional practices that are ethical, responsible, principled and patient-centred. They prohibit kickbacks, bribery or other inducements to doctors, and any promotion for unapproved uses of our medicines. These company policies are supported by regional marketing practices codes which apply the same standards but reflect differences in market structures, national healthcare systems and regulations. A new US PhRMA Code on interactions with healthcare professionals (HCPs) came into effect in January 2009 and we have fully aligned our sales and marketing practices to the requirements of the Code. In some cases, GSK has gone beyond the requirements of the Code, including phasing in a prohibition on giving non educational items in the US, and reinforcing a $150,000 cap on payments made to an individual US-based HCP working as a consultant to the company, for example by participating in an advisory board or speaking at GSK-sponsored meetings. Our updated Commercial Practice Policies (CPPs) will be available in the first quarter of 2009. GSK is initiating a review of all internal, regional codes relating to the sales and promotion of our pharmaceutical products. Through this review, we intend to align, where legally and culturally appropriate, GSK¶s regional codes. This alignment will lead GSK to develop more detailed global principles guiding the sales and marketing of GSK pharmaceutical products all over the world.
Helping to strengthen industry codes GSK supports efforts to strengthen marketing standards across the pharmaceutical industry. This benefits us by creating a µlevel playing field¶ in the countries in which we operate and helps to improve
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
the reputation of the pharmaceutical industry as a whole. In 2008, we took an active role in working with the US pharmaceutical industry association, PhRMA, to develop the changes to its Code on Interactions with Healthcare Professionals. GSK will certify compliance to the Code during the first quarter of 2009. The Code will guide the sale and marketing of GSK pharmaceutical products in the US. Our Marketing Codes of Practice in summary
Full and accurate information ± information can only be provided on approved uses for a medicine. It must be based on valid scientific evidence and must be accurate, balanced, fair, objective, unambiguous and up to date Promotional items to healthcare professionals ± branded promotional items must be given only occasionally and must be relevant to the practice of medicine. Their nominal value was no more than $10 or less than 6 in the UK in 2008. From 2009, we will no longer distribute non-educational items in the US, in line with the US PhRMA code. Items cannot be given as an inducement to prescribe any of our medicines or to medical professionals retained as consultants to GSK Appropriate hospitality for meetings ± no entertainment is permitted. Hospitality, such as travel costs or food, may only be provided for meetings with an educational or professional purpose. The level of hospitality must be appropriate to the occasion and must only be provided for relevant healthcare professionals, not spouses, children, office personnel or any other guests Decisions about grants for medical education are reviewed by qualified medical or scientific personnel
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Home Responsibility Ethical conduct Marketing ethics Relationships with healthcare professionals
Corporate Responsibility Report 2008 Relationships with healthcare professionals Approach
Performance & plans
As well as our marketing codes we have detailed policies and monitoring systems governing our relationship with healthcare professionals in the following areas: Medical education programmes ± we provide funding to enable physicians, pharmacists, nurses and other healthcare professionals to attend education courses and conferences in therapeutic areas relevant to GSK. We do not consider this to be part of our marketing and our policies state that the content of the education programme or the choice of faculty should be independently approved Sponsoring speakers ± we provide sponsorship for healthcare professionals to attend conferences to present their research results or to speak on healthcare issues. Speakers must declare during their speech that they are funded by GSK Advisory services ± we engage with healthcare professionals to understand unmet medical needs and developments in science and treatments. This helps us to understand current and future markets for our products. This engagement may take the form of convening advisory panels or conducting broader market research Read how we engage with healthcare professionals who conduct medical research on our behalf. Our policies and processes vary by region to comply with local laws and industry practices. They meet or exceed the codes on relationships with healthcare professionals from the following industry organisations: The Pharmaceutical Research and Manufacturers of America (PhRMA) The European Federation of Pharmaceutical Industries and Associations (EFPIA) The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) The Japan Pharmaceuticals Manufacturers Association (JPMA) Our policies and processes are further restricted in the US where they include: A limit on payments to healthcare professionals through speaker and advisory fees of $150,000 a year for an individual physician. The majority of our US healthcare professional consultants receive fees that total less than $10,000 per year A state reporting system for expenditure with healthcare professionals, in line with legislation in several US states. This system can help us to investigate situations where excessive meals and gifts may have been provided by GSK A requirement that GSK funding of grants to any healthcare-related group, including patient advocacy groups and physician associations, cannot exceed 25 per cent of the group¶s annual income A speaker evaluation process covering healthcare professionals sponsored by GSK. This requires our regional medical scientists to evaluate high-frequency speakers, and to provide feedback to the healthcare professionals on their effectiveness and compliance with the GSK Speaker Programmes policy A process to monitor questions posed by doctors to our medical information department about off-label uses of our products, and the number and type of referrals made by individual representatives. This helps to ensure that representatives are not promoting off-label uses. All questions from doctors on off-label uses
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for our products must now be referred to our medical information department.
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Home Responsibility Ethical conduct Marketing ethics Relationships with healthcare professionals
Corporate Responsibility Report 2008 Relationships with healthcare professionals Approach
Performance & plans
United States We make payments to healthcare professionals for consultancy work such as participating on an advisory board or speaking at GSK-sponsored meetings. The majority of our US HCP consultants receive fees that total less than $10,000 per year. However, in 2009 we reinforced a cap on payments to HCPs in the US of $150,000 a year for an individual physician. It is in our interest that the physicians we work with do not receive excessive funding from GSK. This ensures that their work for GSK does not detract from the time they spend with patients or conducting research, which could reduce their professional credibility and their value to GSK as sources of current medical expertise.
Europe In 2008, we changed our European code of practice on interactions with healthcare professionals in response to a new Code of Promotion published by the European Federation of Pharmaceutical Industries and Associations. We made the following changes and refinements to our code: Use of consultants ± GSK employees responsible for selecting consultants must have the expertise to evaluate whether the consultant is suitable to meet the identified business need and is of real value to GSK. The consultant is required to declare the consultancy arrangements when speaking publicly on a related issue. Samples ± Product samples are now to be given only in limited numbers and for a limited time, by reference to local standards, for the purposes of familiarisation. This replaces previous limits that were less restrictive and did not specify a quantity or timeframe. Grants and donations ± We introduced a new policy on grants and financial donations to health organisations. We are not involved in how the grant or donation is used and receive no service in return. The new policy states that grants and donations: May only be given to a health organisation in response to an unsolicited request and only for the purposes of healthcare or research Must not be offered or given on the understanding that the recipient will prescribe or recommend our products Must be documented and published externally. To meet this requirement the amount of the grant and the recipient will be published on GSK¶s website from 2010 Are only permitted to health organisations rather than individuals Phase lV clinical studies ± These are studies conducted after a medicine has been approved for marketing. We clarified the principles behind these studies, clearly setting out the terms for GSK and collaborative studies: Studies must not be commissioned as an inducement to prescribe, supply or recommend medicines. They must have a clear scientific and/or educational purpose There must be a contract with the institution undertaking the research
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The trial protocol must be reviewed and approved by an ethical committee, where available GSK R&D or medical personnel must approve and supervise studies Results will be distributed to investigators
Asia Pacific, Japan and Emerging Markets GSK continues to be very active in the IFPMA Code Compliance Network and many of our senior country managers have been very supportive of leading industry change as part of strengthening local codes Nigeria GSK has received the µBest Compliant Company¶ award issued by NAFDAC (the regulatory authority). This award is the first of its kind and aims to encourage compliance among companies in Nigeria and to encourage Nigerians to buy from companies deemed to be compliant by NAFDAC. Australia From January 2009, GSK Australia has stopped distributing brand reminders to healthcare professionals, including pens and notepads, with the exception of new brand launches. This aligns our behaviour with community expectations of how we interact with customers.
Our plans We will publish grants and donations made in the US during 2009, and in Europe by 2010. In Australia, an initiative to move all States to the Victoria operating model will take effect from 1 August 2009, delivering improved control around samples accountability and security, and supporting our aim to achieve the highest levels of professional standards. The field sales force will no longer distribute samples directly to healthcare professionals. Instead, orders will be taken by our medical representatives and samples delivered direct to surgeries from our central warehouse. GSK¶s International Promotion and Marketing Code, applicable to Emerging Markets and Asia Pacific regions, will be subject to its regular two-year review. The last revision incorporated major structural change to align with the structure and content of the IFPMA code and indeed goes further in many cases.
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Home Responsibility Ethical conduct Marketing ethics Direct-to-consumer advertising
Corporate Responsibility Report 2008 Direct-to-consumer advertising Approach
Performance
In the US it is legal to advertise prescription medicines to consumers through TV and print advertisements. This is known as direct-to-consumer (DTC) advertising. New Zealand, Bangladesh and Korea also allow limited DTC advertising. DTC advertising of prescription medicines is not permitted in other markets. Promoting the use of prescription medicines directly to consumers can raise concerns. Critics believe that it encourages people to request unnecessary treatment, adding to the burden on healthcare systems. We believe that responsible pharmaceutical advertising is a useful source of health information for patients. It helps to increase knowledge of conditions and educates patients about treatment options. In countries such as the US where DTC advertising is common industry practice, we would be at a competitive disadvantage if we did not promote our products in this way. Patients must still consult with their physicians about their condition, the appropriateness of a prescription medicine and obtain his or her consent before receiving such medicines.
Prescription medicines in the US Our DTC Communications policy is based on the PhRMA Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines. We have a detailed approval process for DTC advertising, which includes review by legal, regulatory and medical specialists as appropriate. All US marketing employees have received training on our DTC policy. All DTC television advertisements, including audio and visual components, are submitted to the US Food and Drug Administration (FDA) for review at least 30 days in advance of broadcast. Members of the public and healthcare professionals can send comments or complaints on DTC advertising to PhRMA¶s Office of Accountability, which reports the comments and the responses of the companies to the FDA. The FDA Amendments Act 2007 imposes restrictions on DTC advertising. It gives the FDA the ability to require submission of DTC television advertisements 45 days prior to dissemination and imposes a new standard on presentation of safety information in broadcast advertisements. Companies responsible for false or misleading DTC advertisements can now be fined up to $500,000. We have implemented these provisions in our DTC advertising in line with the Act¶s requirements. We fund disease-awareness campaigns which are designed to increase understanding of a specific disease but are not linked to the promotion of GSK products. These are also governed by our DTC policy. Our disease awareness campaigns include television and print advertisements, and direct mail. They do not mention specific GSK products but make people aware that treatments are available for their condition and encourage them to see their doctor. Campaign materials are branded to indicate that they have been produced by GSK.
Over-the-counter medicines and consumer healthcare products Our advertising for over-the-counter medicines, oral healthcare and nutritional products is governed by national regulations or codes of practice for advertising. Our over-the-counter medicines are also promoted
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to pharmacists, doctors and dentists by our sales teams. We belong to the Consumer Healthcare Products Association in the US and comply with its Code of Advertising Practices for Non-prescription Medicines. GSK Consumer Healthcare advertising is reviewed by Copy Review Committees in our larger markets, or by medical and legal personnel in our smaller markets, before publication to ensure it meets our standards.
Advertising to children Our guidelines for advertising to children prohibit advertising designed to appeal to, or targeted at, children below the legally mandated minimum age. For example, to comply with our guidelines in the UK we do not buy advertising space in children¶s media and we do not supply vending machines to primary schools. Sports star sponsorship is important to brands such as Lucozade Sport. Our guidelines state that only people who set an appropriate example should be used for sponsorship, and they should have an appeal that is not solely to children below the age of 13. Our principles for DTC advertising in the US
Our policy requires that DTC advertising should: Dedicate an appropriate amount of time to educating healthcare professionals prior to initiating DTC promotion for a new medicine or new therapeutic indication for an approved medicine Be designed to educate consumers about the medicine and the condition for which it is prescribed Be accurate and supported by evidence Include information on the risks and benefits of treatments Provide information on other treatment options such as diet and lifestyle changes, where these are referenced in the prescribing information for a product Only be targeted at an audience at least 80 per cent of whom are adults
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Home Responsibility Ethical conduct Marketing ethics Direct-to-consumer advertising
Corporate Responsibility Report 2008 Direct-to-consumer advertising Approach
Performance
In 2008 no problems with GSK US DTC advertising were identified by the FDA nor did we receive any comments from the PhRMA Office of Accountability relating to GSK DTC print advertisements. In February 2009 GSK received a letter from the US Food and Drug Administration Division of Drug Marketing, Advertising, and Communications saying that a television advertisement presented a misleading suggestion of superiority to other drug therapies and overstated the efficacy of GSK¶s product Avodart. The advertisement aired from March to September 2008 and was no longer in use at the time the letter was received. We are continuing to make every effort to ensure that future advertisements incorporate the directions provided to us by the FDA.
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Home Responsibility Ethical conduct Training and awareness
Corporate Responsibility Report 2008 Training and awareness Training and awareness programmes help employees understand the importance of ethical conduct and to apply our policies in practice. New employees in the UK and the US complete induction training on our Code of Conduct, which is available on our intranet site. Our annual management certification programme requires managers to confirm that they comply with our ethics policies. The programme covers over 14,000 managers worldwide. Managers can access three e-Learning modules on ethical leadership. Specialised training is provided for employees working in R&D, manufacturing and sales and marketing, where there are additional regulatory requirements. Our corporate ethics and compliance intranet contains links to all company policies, ethics and compliance training for new recruits, an ethical decision-making model, an ethics quiz, contact details for compliance officers and the free phone numbers for our Global Confidential Reporting line. As well as this phone line which is available in over 25 languages and can be used for reporting any concerns employees may have relating to compliance with our policies and the Code of Conduct, we also have an Integrity Helpline based in the US. This provides advice to callers, from both within and outside the company, on Code of Conduct issues, as well as being a reporting channel. Training for employees working in sales and marketing includes: Induction training and testing on our marketing code of practice Detailed training for sales representatives on the medicines they promote and the diseases they are designed to treat Regular refresher courses held at least once a year Regular management updates in Europe, Emerging Markets and Asia Pacific and the US on the types of unethical conduct detected and disciplinary actions taken Ethics training in practice
Ethics training helps employees make the right decisions and apply our policies in practice. For example, new employees are encouraged to ask themselves the following questions before making a decision: Is it legal and ethical? Is it consistent with GSK policy and the Code of Conduct? Is it consistent with GSK¶s Mission and Spirit? Can I explain it to my family and friends? Would I be comfortable if it appeared in a newspaper? We also run ethical decision-making training for established employees and leaders. During training employees explore ethical dilemmas they may face in their work and receive guidance to help them understand the appropriate response. This is one example of an ethical dilemma: When you arrive at the office, there is a large gift basket filled with very expensive chocolates and other gourmet treats on your desk. You estimate its value at $250. Enclosed is a note from a consultant: ³Thanks for choosing us as your consulting partner. We look forward to working with you.´
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You should: a. Keep the gift for yourself. Since you already chose the consultant, the gift can¶t be considered as having influenced your decision b. Call the owner and explain that while the gift was certainly thoughtful, you cannot accept it because it is against GSK policies to accept such an item. Tell her that you will be returning the gift basket and that you look forward to working with her firm c. Put the goodies by the office coffee station for everyone to enjoy The best solution is to return the gift, answer (b).
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Home Responsibility Ethical conduct Training and awareness Leading by example
Corporate Responsibility Report 2008 Leading by example Our senior managers are expected to lead by example by complying with company policies and by supporting their staff to do the same. This is reinforced annually by a formal µManagement certification on business ethics¶ in which over 14,000 managers confirm their understanding and compliance with the company policies contained in the Employee Guide to Business Conduct. Management certification promotes awareness of GSK¶s ethical standards and company policies. It emphasises the importance of the company policies to thousands of other GSK employees who, in the course of their daily activities, must comply with the law and company policies in the conduct of company transactions. This is the full certification statement: I understand that GSK is committed to the principle of performance with integrity, and in particular, to ensuring that its activities comply with all applicable laws. I have received a copy of or have access to the GSK Code of Conduct (POL-GSK_001) and other GSK corporate policies through the Corporate Policy Index page accessible on the Corporate Ethics & Compliance Community. I have read and understand The Employee Guide to Business Conduct, accessible on the Corporate Ethics & Compliance Community. I have complied with applicable laws, regulations, and GSK corporate and local policies and procedures. I understand my responsibility to promptly report any actual or suspected violations of the law, regulations, or GSK corporate and local policies and procedures. I have reported all actual or potential compliance issues of which I am aware concerning legal requirements or company policies. The following statements are also applicable to supervisors with personnel management responsibility: All people under my supervision have received copies of or have access to the GSK Code of Conduct and other applicable GSK policies and have been informed of their responsibilities. I have put in place appropriate measures to ensure that the people under my supervision comply with applicable laws, regulations, and GSK corporate and local policies and procedures while working on behalf of GSK. All new hire employees under my supervision have completed or are scheduled to complete the GSK Corporate Ethics & Compliance new hire training program at GSK Induction or through the Corporate Ethics & Compliance Community. I have read, understood and shall comply fully with the policies and procedures specified in the learning activity.
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Home Responsibility Ethical conduct Training and awareness Performance
Corporate Responsibility Report 2008 Performance and plans Global GSK intends that ethics and integrity are a part of all that we do; therefore, the following key ethics and integrity principles and messages are provided to our business training groups across the company for integration into regular training courses: GSK has an unwavering commitment to conducting business with integrity and in full compliance with the law Every GSK employee is personally and professionally responsible for helping GSK maintain its organisational integrity and good reputation. Profits without principles are short lived When faced with difficult ethical situations, reference the ethical decision-making model. - Is it legal? - Is it consistent with company policy? - Is it consistent with GSK values and Code of Conduct? - Can I explain it to my family and friends? - Would I be comfortable if it were printed in the newspaper? - Will it benefit all or most of the people involved? Our training describes where GSK employees can obtain assistance: - Manager - Corporate Ethics & Compliance web community - Human Resources - Legal - Compliance officers and champions - Integrity Helpline based in the US Other training and awareness activity in 2008 included: Over 14,000 managers completed our self-certification process in 2008 We launched training for new general managers and site directors on their compliance responsibilities, as well as wider monitoring and compliance arrangements at GSK We added µPerforming and Leading with Integrity¶ training to our induction programme. This focuses on ethical decision making and our code of conduct We raised awareness of our Global Confidential Reporting Line through an extensive poster campaign and awareness programmes on our intranet. Our Confidential Reporting phone line is now available in 70 countries and more than 25 languages Our target to set ethical leadership objectives for all of our top managers was put on hold during the transition to the new CEO. We are planning to implement, track and assess ethical measures at the executive level of the company in 2009.
United States Over 9,900 employees and contractors completed compliance refresher training. New hire training was completed by 728 people
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We launched a redesigned training curriculum for new US Pharmaceuticals field sales employees. The curriculum integrates training on ethical commercial practices with sales training, rather than providing it as stand-alone modules. We will integrate compliance training with a range of other sales training programmes in 2009 We added an ethics section to our employee manual of commercial policies. This expands on the policies to provide information that helps people make the right decisions during commercial interactions
Japan Our promotion compliance team trained 2,846 employees on the GSK Promotional Code, including the entire sales force, marketing employees, clinical trial monitors and other employees who interact with healthcare professionals. All employees who took this course submitted a letter which pledged compliance with our standards and the law.
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Home Responsibility Ethical conduct Monitoring and compliance
Corporate Responsibility Report 2008 Monitoring and compliance Approach
Performance and plans
All our managers are accountable for managing risks of non-compliance with our policies in their areas of responsibility. They are overseen by and can seek advice from our corporate ethics and compliance department that promotes effective compliance programmes, addresses compliance issues, and reports problems and progress to senior management and the Board. We have a dedicated compliance officer for each of our business units: R&D, Manufacturing, Vaccines, Pharma Europe, Pharmaceuticals Emerging Markets, Pharmaceuticals Asia Pacific and Japan, Consumer Healthcare, Corporate, US Pharmaceuticals, and additional compliance representatives in some markets. Compliance officers are senior managers with direct access to the leadership teams of GSK functions. They are a source of expertise for anyone with a question on ethics or GSK policies. Our corporate compliance officer reports directly to the CEO. To further develop GSK¶s internal infrastructure, new full-time compliance director positions were also established during 2008 in Latin America, Middle East-North Africa, Asia Pacific and China. This further demonstrates our ongoing commitment to provide dedicated and focused support to our senior management teams globally. Previously such support was via 'champion' roles which were fulfilled by individuals who had additional functional responsibilities beyond ethics and compliance.
Risk management Our Risk Oversight and Compliance Council (ROCC), which includes several Corporate Executive Team (CET) members, oversees risk management and internal control activities. The ROCC is supported by GSK¶s corporate assurance department and corporate ethics and compliance department. GSK¶s corporate compliance officer, who chairs the ROCC, regularly reports on significant risks to the CET and the Audit Committee of the Board. For more information on risk management see the corporate governance section of our Annual Report. Monitoring for sales and marketing Sales representatives are supervised by their managers who regularly monitor educational events, visits to doctors and expenses. We use a risk-based approach to determine the frequency of our checks on different districts and individual sales representatives. In the US, sales representatives that receive inquiries from physicians about off-label uses of GSK products must notify our medical information department, which responds to the inquiry via a medical information letter. Sales representatives must not solicit off-label questions from physicians. Frequent medical information letter requests by a sales representative can indicate that the employee is prompting questions and promoting off-label uses of GSK products. We monitor requests for medical information letters. Our internal audit department regularly audits our sales and marketing practices globally. Monitoring for payments to healthcare professionals and organisations Payments are recorded and monitored in different ways in different countries. For example, in the US we have introduced a state reporting system for expenditure with healthcare professionals, in line with legislation in several US states. In Japan, payments to individual healthcare professionals and medical institutions are monitored on a quarterly basis and the results are reported to promotion compliance officers and our internal audit department These systems help us to identify situations where excessive meals and gifts may have been provided by
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GSK. Reporting channels Employees are encouraged to seek help on ethical issues and to report any concerns or suspected cases of misconduct. They can do this through their line manager, the Corporate Ethics & Compliance department, a compliance officer or compliance champion, GSK¶s Human Resources and Legal departments, or through our Global Confidential Reporting Line or the Integrity Helpline in the US. In the US, employees can also report concerns through an offsite post office box or via email. Reporting channels are promoted through the Employee Guide to Business Conduct, on the GSK intranet and during training. Addressing misconduct Our Corporate Ethics & Compliance department monitors and tracks allegations and suspected legal, ethical or policy infractions. It ensures that all such allegations are appropriately investigated. Disciplinary action, up to and including dismissal, is taken where necessary. Serious violations of our policies are reported to the Audit Committee of the Board. Back to top
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Home Responsibility Ethical conduct Monitoring and compliance
Corporate Responsibility Report 2008 Monitoring and compliance Approach
Performance and plans
Reviewing our compliance and risk management strategy In 2007 we conducted a review of our corporate ethics strategy. Based on the results of the review, we took steps during 2008 in the following areas to further embed an ethical culture at GSK: Recruitment ± we included questions on ethics and integrity in our recruitment process and our GSK Managers Interview Guide. We carried out more extensive pre-employment checks to ensure we recruit people who share GSK¶s values Training ± we extended ethics and compliance induction training to new employees worldwide. We provided extra training and guidance for employees committing minor breaches to prevent them committing serious breaches in future Global Confidential Reporting line ± we extended our independently managed reporting line to all countries where we operate. For many countries, employees can call in their native language. We undertook an extensive intranet and poster campaign to raise awareness of this service Senior management ± we developed new training and awareness programmes for site directors and general managers who are key representatives of GSK in the countries and locations where they work. This included individual briefings by the executive team for new appointees on their compliance responsibilities Policies ± we streamlined the administration of our corporate policies and procedures. This involved reducing the number of policies and procedures by half, and requiring that employees need only have detailed awareness of the policies and procedures specific to their role Financial fraud - we established a new fraud risk assessment tool to help us prevent financial fraud. Our finance leadership team will regularly review all financial fraud cases Progress on meeting our strategy review objectives is reviewed twice a year by the GSK Audit Committee of the Board. In 2009 we plan to further enhance our Global Confidential Reporting phone line facility. Internet reporting will be introduced in selected countries and languages as our supplier evolves this technology and the number of languages available.
Addressing misconduct In 2008 1,113 employees were disciplined for policy violations Of these, 266 were dismissed or agreed to leave the company voluntarily (known as separations) Other disciplinary actions included documented warnings (847 instances) and financial penalties The 1,113 disciplinary actions included 240 cases of employees breaching sales and marketing codes These 240 cases resulted in 30 dismissals or separations from the company. All the other 210 cases resulted in documented warnings In addition to appropriate discipline, employees staying with the company received retraining and increased monitoring. In some cases retraining is also extended to an employee¶s colleagues to prevent them making
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similar mistakes. The main types of violations this year included: Marketing and promotional activities Good manufacturing/good distribution practices Falsification of documents Travel and expenses claims Code of Conduct issues
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Home Responsibility Ethical conduct Case studies
Corporate Responsibility Report 2008 Case studies Suitability for GSK¶s approved speaker list As well as ensuring that our employees comply with our policies, it is vital that people working on our behalf meet the highest ethical standards. In 2008, the US Pharmaceuticals Compliance Department received information through the GSK Integrity Helpline that a healthcare professional (HCP), who was engaged to speak on GSK¶s behalf, had allegedly failed to comply with company policies during promotional programmes on two consecutive days. GSK reviewed materials from one of the programmes in question and identified a number of issues and policy violations. The person was suspended as a GSK speaker pending the completion of a follow-up investigation. After further investigation, we removed the HCP from our approved speaker list. Responsible marketing for our weight loss treatment Nearly two-thirds of US adults are either clinically obese or seriously overweight. This is causing a dramatic increase in life-threatening medical conditions such as heart disease and diabetes, and adding strain to the healthcare system. But even a small amount of weight loss can greatly reduce the risk of developing associated medical problems. GSK¶s over-the-counter weight loss product, alli (orlistat 60 mg), helps overweight adults lose weight by preventing about 25 per cent of dietary fat from being absorbed in the gut. 1 It helps people lose 50 per cent more weight than diet and exercise alone. 2 alli was launched in the US in June 2007 and since then we have sold over six million starter packs. In 2008, alli received a positive opinion from the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use and in January 2009, the European Commission granted a non-prescription licence for the product. It is vital that alli is marketed responsibly so that it is used in the right way and only by those who need it. We educate physicians, dieticians and pharmacists to ensure alli is sold appropriately and patients receive the right information about the treatment. Our marketing emphasises that using alli requires lifestyle changes, including exercise and a low-fat diet, to produce the right results without unwanted side effects. The safety and efficacy profile of orlistat is well documented and has been established through data from more than 100 clinical studies. 3 We set up the website www.myalli.com to provide further support for alli users. It enables people to set targets, track their weight loss and post success stories. It includes an µam I ready for alli?¶ quiz, which asks potential users to confirm their commitment to moderating their diet, taking exercise and reading the label carefully. The site also includes µalli circles¶, an online moderated forum where users can share experiences and help each other stay focused on their weight loss targets. The forum gives us valuable feedback from patients on the effectiveness of the product, and we monitor the site for reports of adverse effects which are then reported to the FDA, and for inappropriate content. In 2008, we donated $75,000 to Dress for Success (DFS) to mark the one-year anniversary of the US launch of alli. DFS is an international non-profit organisation that provides business clothing and career support for disadvantaged women. We encourage alli users to volunteer for DFS and to donate clothing that becomes too big for them as they lose weight. DFS has so far received over 38,000 pieces of clothing from alli users. 1. Anderson J. Orlistat for the management of overweight individuals and obesity: a review of potential for the 60-mg, over-the-counter dosage. Expert Opin Pharmacother. 2007;8 (11):1733-1742. 2. alli Summary of Product Characteristics (SPC) 3. Jacob S, Togerson J. Orlistat treatment beneficial in both primary care and tertiary settings. obesity
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reviews. 2005;6(s1):166.
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Home Responsibility Ethical conduct Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders. Can one company on its own establish high standards of ethical conduct, or is an industry approach required? We set our own high standards of ethical conduct which we hope will establish a benchmark by which all companies are judged. We also work with other companies through trade associations to develop high ethical standards. We believe that it is in the best interest of patients if the pharmaceutical industry adopts common high standards of ethical conduct. This will also help to improve trust in the industry among all our stakeholders. A lot of GSK employees were dismissed for unethical conduct. Are your policies working? In 2008, 266 employees were dismissed or agreed to leave the company voluntarily as a result of policy violations. Unethical conduct occurs in all companies. We believe these figures demonstrate the effectiveness of our monitoring and compliance programmes. Furthering our ethical culture, recruiting the right people, providing the right training and tools, improving our checks and encouraging people to speak up enable us to identify and address unethical conduct in a consistent and responsive manner. Is GSK unduly influencing doctors? We take several approaches to protect against inappropriate influence of doctors, including regional marketing codes of practice, regular training and monitoring. Our policies apply to all employees and agents and commit us to promotional practices that are ethical, responsible, principled and patient centred. They prohibit kickbacks, bribery or other inducements to doctors and any promotion for unapproved uses of our medicines. Our sales force is regularly trained and supervised by managers who monitor educational events, visits to doctors and expenses. How do you prevent off-label promotion? All GSK employees dealing with healthcare professionals undergo extensive training and monitoring. They are instructed that only full and accurate information may be provided on approved uses for a medicine. It must be based on valid scientific evidence, and must be accurate, balanced, fair, objective, unambiguous and up to date. Questions from doctors on off-label uses for our products must be referred to our medical information department. In the US, additional processes are in place for monitoring these referrals to help us ensure that representatives are not promoting off-label uses. We now monitor both the volume of letters responding to questions and the types of referrals made by our individual representatives, for example the number of referrals relating to a particular product or a particular off-label use. Additionally, our internal audit department regularly audits our sales and marketing practices globally. The Advertising Standards Authority ruled that health claims in a Horlicks advert shown in the UK were unsubstantiated. Is GSK involved in false advertising? No, GSK was not involved in false advertising. In 2008, Nepali TV, a Bengali-language satellite channel aimed at viewers on the Indian sub-continent, briefly aired an advert into homes in the UK. However, the advert is intended and approved for use only in India. This was done without our knowledge. The health claims in the advert are not appropriate for the UK as the claims in the advert relate specifically to the Indian market and the Indian diet. The Advertising Standards Authority in the UK upheld the complaint against Nepali TV for broadcasting the
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advert in the UK and did not reprimand GSK. The UK Office of Fair Trading (OFT) is investigating whether supermarkets and suppliers have been wrongly sharing information on prices. Are GSK consumer products involved? In 2008 the UK Office of Fair Trading (OFT) began an investigation into potential breaches of competition law by more than 20 companies, including GSK. The OFT is looking into claims that data on pricing was passed to rival companies through suppliers. It has asked GSK for our cooperation, but we have not been accused of breaking the law. We do not tolerate unethical behaviour. Corrupt and anti-competitive behaviour undermines fair competition, inhibits economic development and is bad for economies, business and people. Our code of conduct sets out our expectations for employees and we conduct training to ensure that we operate within the letter and spirit of the law and maintain high standards of ethical business behaviour. We are cooperating fully with the OFT and we will take disciplinary action, up to dismissal, if a GSK employee is found to have breached our policies or the law.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain
Corporate Responsibility Report 2008 Supply chain We want to source from companies that maintain high labour and environmental standards. Inadequate environment, health and safety (EHS) and human rights standards are an indicator of poor management. This can impact on quality, compromise patient safety and impede continuity of supply of essential medicines. Association with poorly performing suppliers could also damage our reputation. We conduct detailed assessments of new and existing suppliers to monitor their performance on EHS and human rights issues. We work closely with our suppliers to prevent disruptions to the supply of our key medicines. Counterfeit drugs can pose a serious threat to patients. We build anti-counterfeiting features into our products and packaging and we take steps to prevent criminals from making and distributing fake GSK products We are also working to assess the environment, health and safety impacts of our manufacturing suppliers. Our Supply Chain
Number of suppliers: 90,000 Spend: 8.4 bn
We buy goods and services from around 90,000 suppliers. Our supply chain is complex: it ranges from strategic relationships with suppliers that manufacture active pharmaceutical ingredients, intermediates, raw materials and packaging for GSK medicines to contracts for goods and services such as office equipment, cleaning and security.
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Home Responsibility Supply chain Responsibility and our supply chain
Corporate Responsibility Report 2008 Responsibility and our supply chain Our approach to ensuring high standards for our global suppliers includes: Pre-assessments of potential suppliers to gather information and to help evaluation Inclusion of human rights clauses in all supplier contracts and full environment, health and safety (EHS) requirements in contracts for critical suppliers Review of EHS and human rights in routine supplier engagements (for example business performance meetings) EHS audits of potential and existing suppliers Regular progress monitoring and additional advice and technical support
Supplier contracts Our supplier contracts contain EHS requirements based on our global EHS standards and human rights clauses based on the International Labour Organization conventions and the UN¶s Universal Declaration of Human Rights. Companies must agree to our EHS and human rights requirements before they can be included in the selection.
Risk-based approach Our supply chain is large and complex so we use a risk-based approach to target our efforts. We focus on µcritical suppliers¶ which are mostly based in Europe, North America and Asia and account for approximately 30 per cent of our supplier spend. Critical suppliers include contract manufacturers and suppliers that present the greatest risk to GSK on one or more of the following issues: Relevance to the supply of essential medicines Threats to continuity of supply The value of affected products to GSK Regulatory requirements Hazards associated with manufacturing processes and materials Environmental impacts We develop long-term relationships with critical suppliers and conduct regular monitoring to support the uninterrupted supply of high quality materials and services to GSK.
Training for GSK procurement teams We train all new procurement employees in our standards and requirements for EHS and human rights . This emphasises their role in promoting compliance with the standards. Key procurement employees, including procurement managers, receive ongoing training on these topics. In 2009, we will develop new sustainable procurement guidelines, with supporting training plans, which will focus on sourcing:
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Materials from sustainable sources Products with recycled content Energy-efficient equipment
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Home Responsibility Supply chain Responsibility and our supply chain Human rights clause
Corporate Responsibility Report 2008 Human rights clause Our supplier contracts contain a human rights clause (below) which is based on the International Labour Organizations conventions and the UN¶s Universal Declaration of Human Rights. We may amend the exact wording of the clause during negotiations with suppliers or during translation to suit local law. These changes will not reduce the contractual impact or intent of the clause.
The GSK standard contract clause for Ethical Standards and Human Rights Unless otherwise required or prohibited by law, the Supplier warrants, to the best of its knowledge, that in relation to the supply of goods or services under the terms of this Agreement: 1. it does not employ engage or otherwise use any child labour in circumstances such that the tasks performed by any such child labour could reasonably be foreseen to cause either physical or emotional impairment to the development of such child; 2. it does not use forced labour in any form (prison, indentured, bonded or otherwise) and its employees are not required to lodge papers or deposits on starting work; 3. it provides a safe and healthy workplace, presenting no immediate hazards to its employees. Any housing provided by the Supplier to its employees is safe for habitation. The Supplier provides access to clean water, food, and emergency healthcare to its employees in the event of accidents or incidents at the Supplier's workplace; 4. it does not discriminate against any employees on any ground (including race, religion, disability or gender); 5. it does not engage in or support the use of corporal punishment, mental, physical, sexual or verbal abuse and does not use cruel or abusive disciplinary practices in the workplace; 6. it pays each employee at least the minimum wage, or a fair representation of the prevailing industry wage, (whichever is the higher) and provides each employee with all legally mandated benefits; 7. it complies with the laws on working hours and employment rights in the countries in which it operates; 8. it is respectful of its employees¶ right to join and form independent trade unions and freedom of association; 9. The Supplier agrees that it is responsible for controlling its own supply chain and that it shall encourage compliance with ethical standards and human rights by any subsequent supplier of goods and services that are used by Supplier when performing its obligations under this Agreement. The Supplier shall ensure that it has ethical and human rights policies and an appropriate complaints procedure to deal with any breaches of such policies. GSK reserves the right upon reasonable notice (unless inspection is for cause, in which case no notice shall be necessary) to enter upon the Supplier's premises to monitor compliance by the Supplier of the warranties set out in the clause above and the Supplier shall, subject to compliance with law, furnish GSK with any relevant documents requested by GSK in relation thereto. {This sub-section will only be required where there is no general right of audit elsewhere within the Agreement} Back to top
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Home Responsibility Supply chain Responsibility and our supply chain Choosing suppliers
Corporate Responsibility Report 2008 Choosing suppliers We conduct a detailed assessment of critical suppliers before they are selected. Critical suppliers include contract manufacturers and suppliers that present the greatest risk to GSK on one or more key risk areas. We use questionnaires, on-site reviews and EHS audits to assess their performance on health and safety, environmental and human rights issues. We assess potential new critical suppliers against our EHS standards. They must achieve a minimum audit score of 50 per cent against the standards if they are to join our supply chain. Following an audit, many suppliers who have not met our requirements implement plans to improve their EHS performance. We monitor their progress and in some cases provide opportunities for training and technical support to enable the supplier to achieve the required standards. We also expect suppliers who have established supply arrangements with us to make improvements and we monitor their progress through reviews and follow-up visits. The audits also include questions which help us identify potential breaches of the human rights clauses included in supplier contracts. Suppliers are asked for information on policies and practices relating to: Age limits for employees Discrimination against employees and the local population Prevention of abuse of individuals Wages, benefits and working hours (whether they meet the legal minimum) Rights for workers to organise and recognition of worker organisations These questions do not contribute to the EHS audit score, but may be a reason not to progress business with a supplier. Read about our audit programme which ensures compliance with quality standards
Back to top
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Home Responsibility Supply chain Responsibility and our supply chain Monitoring and engagement
Corporate Responsibility Report 2008 Monitoring and engagement Approach
Performance
In order to maintain GSK standards in our supply chain, we routinely interact with our suppliers through reviews and follow-up visits by procurement, quality and EHS staff. We consider EHS and human rights issues in all these interactions. We hold global and regional supplier review meetings where senior GSK managers interact with suppliers on key issues. We provide contract manufacturers with information on the EHS risks associated with the GSK materials they are producing or handling. Our supplier booklet won working with GSK includes our ethics policies and requirements. We conduct regular EHS audits of critical suppliers of pharmaceutical and consumer healthcare products. We focus on the 150 higher-risk suppliers. Supplier facilities are evaluated against our EHS standards and must achieve a score of at least 50 per cent against these standards to demonstrate acceptable performance and to support continuing supply arrangements. Suppliers develop improvement plans based on the audit findings and we follow up to monitor progress against these plans. Read a case study on how we helped a supplier to improve its EHS performance in 2008. We will provide feedback to suppliers if we identify any issues through the questions relating to human rights . We will require corrective action if the issues present a potential breach of the human rights clause included in supplier contracts.
Suppliers of promotional items Many of the gift items for our Indian business are sourced from within India in an industry with a higher risk of the use of child labour. We conduct unannounced spot checks for these suppliers, often during the night. These focus on maintaining quality standards but are also used to check that suppliers are not using child labour. The spot checks are conducted by GSK procurement and regional sales staff. We have used the findings from the programme in India to inform our promotional supplier qualification process in other regions. We have begun to conduct more detailed inspection of assembly sites where possible and have added extra checks in regions where child labour is more common. Back to top
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Home Responsibility Supply chain Responsibility and our supply chain Monitoring and engagement
Corporate Responsibility Report 2008 Monitoring and engagement Approach
Performance
In 2008, we conducted 30 supplier audits and 20 reviews.The average audit score against GSK EHS standards was 62 per cent; the highest score achieved was 84 percent and lowest was 40 percent. 2008 EHS audit scores of key suppliers
* Americas = Canada, North America and South America regions The higher average scores in North America and Europe, in contrast to the lower average scores in Asia, are largely related to the maturity of EHS management and the supporting legislative framework and its enforcement in these regions. The broad range of scores in the Asia region reflects the higher performing suppliers where there has been long term intervention from GSK. The lower scores relate to suppliers where we have undertaken initial audits and found significant deficiencies in EHS management and risk control. Five suppliers failed to meet our minimum requirement of 50 percent against GSK EHS standards. Potential new suppliers that scored below the minimum level were either not progressed or work is underway to improve performance to acceptable levels. We work with existing suppliers to ensure necessary improvements are made within an agreed timeframe and that GSK standards are applied in our supply chain. The most significant audit findings in 2008 occurred mainly in emerging economies. These included: No infrastructure for fire protection and poor emergency response capabilities Absence of fundamental risk controls for process safety Poor control of exposure to hazardous substances Poor waste management and environmental controls Frequent regulatory findings No significant issues were identified relating to the human rights questions we ask during audits.
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In 2008 we continued to work with a number of key suppliers to help improve their EHS performance. This included: Developing closer relationships - We have two full-time positions, in China and India, to support our work with audited suppliers and improve their EHS performance. Their work includes helping the suppliers to develop improvement plans and providing them with coaching opportunities. Read more in our case study on how we helped a supplier to improve its EHS performance in 2008. Attending supplier forums through the R&D-based Pharmaceutical Association Committee (RDPAC), an industry consortium in China. The forums provide the opportunity for GSK to engage with suppliers, and for supplier companies to take advantage of training and networking. Making progress in a pilot project for a strategic supplier to achieve µHighly Protected Risk¶ (HPR) status. To achieve HPR status, a µbest in class¶ insurance industry designation, companies must adopt an engineering approach to minimising property and supply chain risks. Our plan is to extend this to other strategic suppliers Number and type of audits in 2008 Americas*
Europe
Asia
Africa
Total
Type of supplier
Primary (raw materials, intermediates and active pharmaceutical ingredients)
3
12
17
0
32
Pharmaceutical (formulations)
3
5
0
1
9
Consumer Healthcare (excipients, actives, raw materials)
0
1
11
0
12
Type of engagement
Audit
4
13
16
0
33
Review
2
5
12
1
20
Average audit score (per cent)
79
68
53
-
Number of suppliers audited between 2002 and 2008
Total number visits
Americas*
Europe
Asia
Africa
Cumulative Total number visits
2002
9
0
8
1
0
9
2003
18
0
12
6
0
27
2004
29
3
9
17
0
56
2005
40
7
8
23
2
96
2006
32
0
13
18
1
128
2007
55
10
8
37
0
183
2008
53
6
18
28
1
236
* Americas = Canada, North America and South America regions
Suppliers of promotional items In 2008 we conducted five unannounced spot checks of promotional goods suppliers in India (at least one visit for each company supplying promotional goods to our Indian business in 2008). These uncovered no
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evidence of child labour.
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Home Responsibility Supply chain Responsibility and our supply chain Supplier diversity
Corporate Responsibility Report 2008 Supplier diversity Small and minority-owned companies are often under-represented in the supply chains of large companies. In response, the US government and many large companies require their suppliers to source from diverse companies. The Broad-Based Black Economic Empowerment Bill 2003 in South Africa includes similar requirements. We are working to increase the diversity of our supply chain by providing opportunities for small, diverse businesses to provide us with goods and services. This helps diverse suppliers to sustain their businesses, create jobs and boost their local economies. Our business also benefits. Beyond complying with regulations, supplier diversity encourages innovation and exposes us to new perspectives and fresh ideas.
US programme In the US, we have a dedicated team working to create opportunities for diverse suppliers to work with GSK and to channel our procurement spend to women and minority-owned companies. Its activities include: Participating in national and local diversity councils Mentoring high-potential diverse suppliers and providing improvement grants to help them expand their business with GSK and other corporations. Read more in our case study Sponsoring diverse business leaders to attend executive programmes at the Tuck School of Business and Kellogg School of Management Sponsoring and attending outreach and networking conferences We co-sponsor the Congressional Black Caucus Foundation (CBCF), a non-profit organisation that supports African Americans and under-served communities in the US. We are donating $500,000 between 2005 and 2009 to the Foundation to provide training to help make diverse businesses more competitive. We also support an initiative, run by the CBCF, to help change federal policy that can restrict long -term relationships between minority- and women-owned businesses and major corporations. We sponsor Roanoke Online, a technology company that hosts an online database and electronic sourcing system for diverse suppliers. This gives large companies, including GSK, better access to diverse suppliers. Corporations gain access to a large, diverse pool of contractors, which ultimately helps them lower their costs, while the small diverse suppliers get the chance to grow their businesses through increased opportunities to supply companies traditionally beyond their reach. As part of the Adopt a Neighbourhood for Development initiative, our procurement and community relations teams work with local communities in Durham, North Carolina, and Philadelphia, Pennsylvania. These areas are historically deprived and are often overlooked by companies when choosing where to locate their businesses. GSK provides an annual grant to support self-development within the communities to make these areas more attractive as business locations.
Outside the US GSK¶s dedicated supplier diversity team is based in the US, but all procurement employees worldwide are responsible for supporting diverse suppliers where possible. We are a sponsor of the Global Link Programme as part of our role on the International Advisory Board of the US National Minority Supplier Development Council. The Programme helps diverse suppliers develop partnerships with local businesses around the world. In collaboration with two other pharmaceutical
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
companies, we paid for ten US-based minority-owned companies to visit South Africa in late 2007. The companies met diverse South African businesses and got the chance to form partnerships to help them compete globally. We have also participated in similar trips to Australia, Brazil and China. The initiative has enabled GSK to invest in the local economies of communities we serve and helps ensure our supplier base reflects the diversity of those communities. GSK is a member of the new UK Minority Supplier Development Council. The Council forms a link between corporations and certified minority business enterprises, with the aim of increasing procurement and business development opportunities.
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Home Responsibility Supply chain Responsibility and our supply chain Fair treatment of suppliers
Corporate Responsibility Report 2008 Fair treatment of suppliers It is important that we foster relationships with our suppliers which are characterised by mutual trust and respect. GSK has established procurement policies which require high standards of ethical conduct and integrity. Our general terms and conditions are on our website. As part of our supplier review process, we have a two way dialogue to identify areas for mutual improvement and to provide an environment where suppliers can discuss issues and present new ideas. We support impartiality in all phases of the procurement cycle. Our global electronic bid system ensures all suppliers are treated fairly and equally. The vast majority of suppliers that provide goods and services to GSK are registered on the system. Companies that are invited to bid to supply GSK all receive the same information at the same time, for example invitations to compete and specifications of the supplies required. In 2008, the system managed over 8,000 bidding and negotiation-related events in over 50 countries. For highly competitive goods and services we allow suppliers full transparency of seeing where their bids rank against their competition. Payment of suppliers From September 2008 GSK changed its standard payment terms for uncontracted suppliers in the UK and US from 30 days from the receipt of the invoice to 60 days. We will review our terms and conditions with contracted suppliers on contract renewal or earlier. This step has been taken as part of a project to reduce working capital. We recognise that this may impact the cash flow of our suppliers. However, the new 60-day term brings us more in line with the practice in other industries and is faster than the terms set by some other companies. We realise this may cause genuine financial difficulty for some organisations and we evaluate the implications of this on a case-by-case basis.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Maintaining quality
Corporate Responsibility Report 2008 Maintaining quality Maintaining the quality of the products we make and the materials we buy is essential to the safety of patients and the success of our business. We conduct quality assessments for all suppliers of ingredients and packaging materials used in all of our products. We agree specifications for our ingredients and packaging materials with our suppliers and apply a set of global auditing standards for each type of ingredient and packaging material that we buy. We use a risk-based approach to determine the frequency of audits. In 2008 we conducted 558 audits of our ingredient and packaging material suppliers, compared to 776 in 2007 and 740 in 2006. On receipt at GKS sites, samples are taken and testing is performed according to a testing protocol. All samples are tested for identity. Every batch is also tested against our quality specification. Examples of additional measures in place to maintain quality in our supply chain and prevent contamination include the use of dedicated transport, use of tamper evident seals and the use of sophisticated analytical tools to check the authenticity of the materials we receive. Helping suppliers to meet our quality standards We conduct quality assessments of all potential suppliers. This enables us to identify companies that meet our required standards as well as those we can work with to make the necessary improvements. For example, we identified one of our existing chemical suppliers in Asia that had the expertise to supply the final active ingredient for a GSK product. We worked closely with the supplier to help them develop the technical processes and quality standards to begin trial manufacturing in 2001. This included site visits to advise on configuration of plan and building modifications and assistance in preparing documentation required by regulators. In 2006, the US Food and Drug Administration conducted a four day quality and compliance inspection of the site, which resulted in no adverse findings and approved the site for supply to the US market. Raising employee awareness of our commitment to quality In 2008, Andrew Witty, GSK¶s CEO, endorsed a new, internal quality statement which stresses the importance of quality across all of our business activities, including the critical aspect of product quality. We raised awareness of this statement through discussion at internal Quality Councils throughout our business units, through new articles on our global intranet site, myGSK, and through posters for display at all facilities. Quality statement
Quality is at the heart of all activities that support the discovery, supply and marketing of products to our patients and customers. Quality is critical to building trust with society and, therefore, to our future business success. Andrew Witty, Chief Executive Officer
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Home Responsibility Supply chain Security of supply
Corporate Responsibility Report 2008 Security of supply Ensuring a continuous supply of high quality medicines is essential to the patients who depend on our products, as well as to the success of our business. It is vital that security of supply is not compromised at any stage of the distribution chain. We prepare for major incidents that may disrupt supply, ranging from large-scale theft of products to natural and man-made disasters near a facility. Strategy directors from each therapy area have overall responsibility for security of supply. Divisional heads meet our procurement teams every month to discuss any potential issues. GMS (our manufacturing business) implements contingency plans for µmedically critical¶ products. We define products as µmedically critical¶ if life-saving or those where if they were not available to patients, there is likelihood of serious detriment to health and there is no known alternative. These plans are defined on a product-by-product basis and may include holding sufficient stocks of products or active pharmaceutical ingredients. We work with all critical suppliers to encourage them to implement their own contingency plans. In high-risk countries we will set up joint ventures to ensure that we maintain control over the distribution chain. We have three global contracts for suppliers that deliver goods between GSK facilities and distribute products to market. We conduct regular high-level operational reviews of these suppliers, which include security elements. Read about the measures we are taking to protect our employees in the event of a pandemic flu outbreak to ensure the supply of critical medicines is not disrupted.
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Home Responsibility Supply chain Counterfeiting
Corporate Responsibility Report 2008 Counterfeiting Approach
Performance
According to the World Health Organization (WHO), less than one per cent of pharmaceutical products sold in developed countries are counterfeit, but in the developing world this figure may be higher than 10 per cent, and up to 30 per cent in some countries. Counterfeit drugs come in many variations, and may contain: None of the legitimate active ingredient The active ingredient in reduced or sub-therapeutic amounts A completely different and/or inappropriate active ingredient Impurities such as unapproved colourants or microorganisms Packaging that falsifies the product description or expiry date Most counterfeit drugs are not subject to quality control, hygiene standards, testing of ingredients and monitoring of product specifications or equipment. Counterfeiting is a threat to public health, potentially causing harm to patients and even death. We add anti-counterfeiting features to our product packaging. These include holograms, security seals, complicated background patterns that are difficult to photocopy or scan, as well as a wide variety of covert identifiers which are added using print technologies and sophisticated markers. These help us to identify counterfeits and gather evidence against offenders. Our Packing Design Technology and Security team in the UK carries out forensic examinations of all suspected counterfeit GSK products. Our sales representatives worldwide also play an important role in helping to discover counterfeit products through continual observation of the local market. Our Corporate Security department investigates every potential case of counterfeiting. It uses internal and external investigators to collect information, which we then assess and report to the relevant government authorities to set in motion official law enforcement action. As well as removing fake products from the market, one of our primary aims is to trace the products back to source, to shut down the manufacturers and their partners (for example the packaging printers and distributors). We provide training for regulatory authorities, such as the State Food and Drug Administration (sFDA) in China, law enforcement agencies and customs officers in many parts of the world. GSK works very closely with the wider pharmaceutical industry to investigate cases of counterfeiting and we also raise awareness with governments internationally, pressing for stricter laws and more severe penalties. GSK is a founding member of the Pharmaceutical Security Institute (PSI), which coordinates information collection and investigations within the industry internationally. The PSI is influential in helping to shape anti counterfeiting policy among national governments and international organisations. Together with the PSI, GSK is a major contributor to the WHO¶s internationally represented anti-counterfeiting working groups. Internet pharmacies
There is evidence that a large number of internet pharmacies are involved in the sale of counterfeit or diverted medicines or illegal generic substitutions (switched at the time of delivery for the requested
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
brand name product). Some internet pharmacies provide sub-standard product, engage in a fraud against the customer (using their credit card information for other fraudulent activity) and ignore local laws and regulations relating to licences, prescriptions and patient information, seemingly operating with immunity from prosecution. Internet pharmacies have flourished over the past few years and it is likely that this rise will continue as it provides a lucrative, low-risk opportunity for direct selling to patients in a global and largely unrestricted market. The UK Medicines and Healthcare products Regulatory Agency estimated in 2004 that 600,000 British patients purchased prescription only medicines on the internet and the US FDA reported that 100,000 pills are purchased through internet pharmacies each month in the state of Kentucky alone.
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Home Responsibility Supply chain Counterfeiting Performance
Corporate Responsibility Report 2008 Counterfeiting Approach
Performance
In 2008 there were 289 reported cases of counterfeiting of GSK products. These resulted in 94 raids, during which 84 suspected counterfeiters were arrested and 7 million worth of counterfeit products were found. Of the 94 raids, 22 took place at criminal manufacturing facilities and 54 at wholesale/distribution outlets. The 22 factories represent criminal operations that were capable of mass production of counterfeit medicines and other healthcare products. The raids on these facilities undoubtedly prevented huge amounts of counterfeit product from entering legitimate markets around the world, much more than the 7 million worth of product found at the time of the raids. In 2008 there was a reduction in the number of reported cases of counterfeiting. We see this as a positive sign that anti-counterfeiting measures are working. The number of raids by GSK has risen by 30 per cent as a result of our own proactive security and investigations activity. The number of raids is not directly related to the number of reported cases of counterfeits, these are based on intelligence from our security and investigations activity. GSK is recognised as a leader by the industry in combating counterfeit medicines, and currently chairs the Pharmaceutical Security Institute.
Anti-counterfeiting
Number of reported cases of counterfeit
Number of raids
Number of arrests
Value of counterfeit products found during raids
2008
289
94
84
7 million
2007
429
71
127
15 million
2006
248
57
94
10 million
2005
334
47
31
13 million
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Home Responsibility Supply chain Case studies
Corporate Responsibility Report 2008 Case studies Mentoring diverse suppliers in the US Callis Construction Services (CCS) is a minority-owned contracting company in Durham, North Carolina. The company¶s President, Jesse Callis, took part in our diverse supplier mentoring programme, beginning in 2004, which helps suppliers form partnerships with GSK and other large corporations. As part of the programme, we assessed CCS¶s business processes and identified issues preventing the company becoming a GSK preferred supplier. Concerns ranged from management accessibility to the ability to scale up their supply to the needs of GSK. The company implemented improvements based on our recommendations which enabled it to become a preferred supplier and win business worth around $2.8 million. The success of this partnership enabled CCS to contribute to its local community. It paid for two employees to attend a local university and Mr Callis developed a training programme with Durham Technical College which prepares minority construction workers for management positions on major projects in the area. When asked about his relationship with GSK, Mr Callis said, ³GSK has been a wonderful mentor. They are a real leader in their commitment and actions to help diverse minority suppliers. In my case, they provided assistance that has led to a very significant growth of my business. This in turn has provided jobs for others in the Durham and surrounding area ensuring that monies paid by GSK stay in the local communities. This is a win for everyone involved.´
Helping to improve supplier performance In some cases we provide assistance to suppliers that fail to meet our minimum EHS and quality standards to improve their performance. This enables companies to improve their work practices and win more business. It helps us to develop the supply chain we need to provide a secure supply of high quality medicines. For example, in 2008 we provided support to a potential supplier of active pharmaceutical ingredients in India. The supplier received an audit score of 41 per cent, below our 50 per cent minimum standard. Following the audit we made recommendations for improvement, provided coaching and facilitated meetings between the supplier and expert consultants. In 2008 the supplier achieved an audit score of 55 per cent and was accepted as a GSK supplier. The audit found that the company is managing key risks effectively and has established a detailed improvement programme. We will continue to monitor progress against this improvement plan. The success of this collaboration relied on the efforts of GSK staff as well as the willingness of the supplier to recognise that improvements were needed. It has resulted in a more secure supply chain for GSK and a safer working environment for workers at the facility.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders. What are you doing to raise standards in your supply chain? We have long-term relationships with our critical suppliers and we offer them training and support to help them raise standards. Our monitoring process is a key part of raising awareness of our expectations and identifying areas where suppliers need to improve. We work with our suppliers to help them make the necessary changes identified. Are there human rights risks in your supply chain? GSK¶s supply chain is large and complex, and like all similar supply chains, contains a risk of human rights violations. These risks vary considerably based on the type of supplier and the goods or service we are sourcing. Our manufacturing and R&anp;D suppliers employ skilled workers so there is a lower risk of human rights violations. Our EHS audits aim to ensure good working conditions at these supplier facilities. There are considerably higher human rights risks in suppliers that employ low-skilled workers, for example promotional goods suppliers. We conduct spot checks of these suppliers in India. Our supplier selection process aims to ensure we only enter relationships with suppliers that respect human rights. We also include clauses in contracts with all suppliers which specify that upholding human rights is a condition of doing business with GSK. What are you doing in your supply chain to plan for a flu pandemic? We have implemented a contingency plan to ensure our operations, and the supply of medically critical products, are not compromised by a flu pandemic. We are now encouraging our critical suppliers to implement their own contingency plans. You are outsourcing more manufacturing. Will this mean you have less control over your products, increasing risk for patients? The manufacture of all our medicines and vaccines is closely controlled and subject to the same quality standards, regardless of whether we produce them ourselves or outsource the process to contract manufacturers. Before outsourcing any stage of the manufacturing process, we confirm that the contractor can carry out the required processes to our high standards. All contract manufacturers must also be approved by relevant regulatory authorities, and are subject to inspection by GSK and regulators.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability
Corporate Responsibility Report 2008 Environmental sustainability Sustainability has been defined as meeting the needs of today without compromising the ability of future generations to meet their own needs. GSK is embarking on a journey towards sustainability that we expect to continue for many years. As well as benefiting the environment, our sustainability efforts encourage innovation that provides a better outcome for society and help us to reduce costs. Our early environmental management programmes focused on controlling emissions and wastes from our operations through treatment and disposal systems. Our approach to sustainability is to change the fundamental process to reduce the amount of resource consumed, avoiding waste at source rather than simply treating the waste and emissions that arise. We have already begun changing our business and developing innovative new manufacturing processes. We have set initial sustainability goals to: Double the average efficiency with which we convert raw materials to finished products for new products by the end of 2010 from a 2005 baseline Reduce our energy and climate change impact per unit of sales from 2006 levels by 45 per cent by 2015 Eliminate CFCs in our products and equipment by the end of 2010 Examples of our sustainability initiatives include Reducing the amount of material resources we use such as raw materials and fossil fuels Minimising waste and recycling unavoidable waste Redesigning production processes to eliminate the production of toxic materials Reducing energy consumption and the associated carbon emissions We manage our Environment, Health, Safety and Sustainability (EHSS) programme according to a framework that sets out consistent standards of employee health and safety, environmental protection and sustainability. This framework acts as an internal regulatory system that reflects our understanding of our risks to ensure our operations comply with laws and regulations. It provides information, tools and training to help everyone at GSK meet our standards. It includes targets as set out in the Plan for Excellence to address our fundamental environmental and sustainability impacts. We also work with our suppliers to help them become more sustainable. Openness and transparency are fundamental to our sustainability performance and we will continue to engage with stakeholders to share views and dilemmas. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Plan for excellence
Corporate Responsibility Report 2008 Plan for excellence Our EHSS Plan for Excellence sets out our ten-year strategy to improve environment, health, safety and sustainability performance through to 2015. The details are developed in concert with each business so that the Plan is integrated with business plans and specific actions are identified by each business. The Plan is reviewed every five years and new targets are set. It is designed to support GSK¶s business plans and consists of three strategic priorities: Environment, health and safety fundamentals embedded in the business ± to produce and sustain high EHS performance we need to combine structured systems with the attitudes and values that create a positive EHS culture. To achieve this we need to embed awareness of environment, health and safety concerns and systems in all GSK activities Environmental sustainability ± to embrace environmental sustainability as a driver for competitive advantage we need to define the principles of environmental sustainability and progressively integrate them into the business, translating them into practical action Open and transparent external relations ± external stakeholders who have a legitimate interest in the company¶s environment, health, safety and sustainability affairs should have ready access to relevant information and the opportunity for dialogue about issues that concern them. Building open relationships and partnerships can lead to business opportunities, while failure to engage may damage our reputation Each of these strategic priorities is supported by plans with performance targets in key areas. GSK has worked with our External Stakeholder Panel to help set out our plan and to review our annual performance.
Targets Our EHSS Plan for Excellence includes company targets to improve environment, health, safety and sustainability performance. These are based on site based, practical improvement plans and forecasts from all manufacturing operations. Read more about how targets are set and view details of our company targets Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Plan for excellence 7DUJHWV
Corporate Responsibility Report 2008 Targets We set company-wide targets to drive continuous improvement in managing our most significant environment, health, safety and sustainability impacts (see table). We compare proposals for company targets put forward by operations with benchmarking information and our environment, health and safety professionals, senior managers and management teams throughout the business closely review them and agree on the final target numbers. We believe it is important to set and achieve targets because lower resource consumption and less waste benefit the environment and GSK. Although we are on track to meet most of our targets, we recognise that some will be difficult to meet within the time we have set ourselves. We explain progress to the targets in the discussions on the individual metrics. Read our health and safety targets Targets and progress 2008 Target
Progress from 2006 to 2008
Material efficiency of new processes for actives
2% average for the period 20052010
Material efficiency of 1.6% achieved by 2008
Energy for operations and transport
20% reduction per unit of sales from 2006 baseline by 2010
Increased less than 1% per sales CER
Climate change impact from energy for operations and transport 1
20% reduction per unit of sales from 2006 baseline by 2010
Increased 2% per sales CER
Water
2% annual reduction from 2006 baseline per unit of sales
Reduced 11% per sales CER
Wastewater (chemical oxygen demand)
3% annual reduction from 2006 baseline per unit of sales
Reduced 6% per sales CER
Solid waste
1% annual reduction from 2006 baseline per unit of sales
Reduced 9% per sales CER
Ozone depletion 2
100% elimination by 2010 from 2006
Eliminated 83%
Air emissions (volatile organic emissions)
2% annual reduction from 2006 baseline per unit of sales
Reduced 10% per sales CER
EHS audit scores
Average: 82% by 2010 Minimum: 70% by 2010
Average 78% Minimum 62%
Sustainability targets
Fundamental targets
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1. Climate change impact is measured as CO 2 equivalent emissions 2. Includes ozone depletion potential from production and refrigeration losses Targets and performance normalised by sales are based on a constant exchange rate (CER).
SGS verified Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Plan for excellence Journey to sustainability
Corporate Responsibility Report 2008 Journey to sustainability James Hagan, Vice President, Corporate Environment, Health, Safety and Sustainability, charts GSK¶s history of environmental management and describes how the company is making the shift towards sustainability. Sustainability is defined as meeting the needs of today without compromising the ability of future generations to meet their own needs. For GSK to be sustainable, we need to be efficient in the use of resources, including energy, water and raw materials and we need to use renewable resources. As resources become more scarce and expensive, sustainability and cost will be more closely linked. Ultimately, this means that our ability to continue to manufacture affordable medicines requires us to address sustainability. We have been working towards sustainability since 2001 when GSK was formed. Similar to other industries at that time, the companies that formed GSK started out managing their emissions and waste using treatment and disposal methods and considered management of waste a necessary cost. We soon recognised that while these µbolt-on¶ control measures are essential, they will only ever incrementally improve the impact of waste. To achieve a step-change towards sustainability, we need to make our processes more efficient to prevent waste and emissions being produced in the first place. This fundamental change requires investment in innovative solutions. Through innovation we can create more efficient processes which use less resource and reduce costs. This virtuous circle is completed when we take a portion of our sales and reinvest it in innovation. Sustainability reflects a µbuilt-in¶ approach. To begin guiding our business towards sustainability, we developed a management framework which set out a policy and consistent standards for everyone at GSK to follow. We produced a plan for 2001-2010 which outlined a timetable for achieving the goals set out in the framework and set five-year improvement targets. This plan was refreshed for the period 2006 to 2015. The plan identified manufacturing efficiency as the first area where we could make significant progress toward sustainability. We used a material balance ± a calculation that looks at the amount produced compared to the amounts of raw materials used ± to measure our material efficiency and set an improvement target to double the efficiency for our new products. Our Eco-design toolkit supports the development of these more efficient manufacturing processes. Read more about process design. We have already had some success with new medicines and we think we can improve the processes for some of our existing products as well. Climate change, one of the greatest challenges facing mankind, is a key part of our sustainability strategy. We have set targets to almost halve the amount of energy we use and the CO 2 we produce per unit of sales by 2015. Our sustainability focus extends beyond manufacturing to all aspects of our business, including R&D, sales and other activities. It also includes environmental product stewardship, the responsibility we have for the environmental impact of our medicines. Within GSK, sustainability has started to take root. As an example, our Nutritional Healthcare business has a comprehensive sustainability programme, please read this casestudy for details. They are working with suppliers to examine the lifecycle and biodiversity impacts of raw materials used, developing a ¶zero waste to landfill¶ manufacturing approach, using recycled materials for packaging and developing innovative ways to recover used bottles through reverse vending. Our Consumer Healthcare business has also developed a sustainability strategy called µBright Green¶ which includes packaging, climate change, water use, product stewardship and total supply chain goals.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Although we have made progress in the Nutritionals business and in certain other areas, achieving our fundamental environmental improvement targets and making progress toward sustainability continues to be a challenge. In 2009 we will assess how we can achieve our targets. Of course, we will learn from both success and failure and each year we will explain why we succeeded or failed. We will also continue to broaden our view of what sustainability means to GSK. So far we have focused our attention on sustainability on R&D and manufacturing. Going forward we know we need to broaden that focus to include our sales force and offices. I realise that we have just begun this journey, and that we will need all our commitment and innovation to succeed. Our internal Sustainability Council composed of senior managers is leading our efforts. We also have an External Stakeholder Panel that gives feedback on our approach and performance and suggests improvement alternatives. I recognise the value that all of our stakeholders can bring so I welcome your views on our approach. Please feel free to let me know your thoughts by emailing me at [email protected].
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Managing EHS and sustainability
Corporate Responsibility Report 2008 Managing environment, health, safety and sustainability We manage our environment, health, safety and sustainability issues using a management system aligned with recognised management system standards such as ISO 14001 and OHSAS 18001. Our management system is based on a structured framework that starts with a vision and policy. The policy is supported by standards, guidance materials, tools, training, recognition and audits that assist the business to manage environment, health, safety and sustainability at their sites throughout key business operations. Systematic audits assess sites¶ adoption of a management systems approach to manage their risks. The framework defines our: EHSS vision and policy which set out the broad principles we expect our operations to meet EHSS standards that outline specific requirements for our company based on our EHSS risks. These meet or exceed applicable laws and regulations and are consistent with the international standards ISO14001 and OHSAS 18001 based on a management systems approach EHSS guidelines that support the EHSS standards by providing further information on the requirements of the standards and setting out an approved approach for achieving compliance. They incorporate good practice from both within and outside GSK. A wide range of information supplements the EHSS guidelines. This includes technical information and training materials to help our employees understand and implement our EHSS management system Audits that assess the implementation of management systems Reward and recognition that recognises teams who have made outstanding progress towards achieving our goals The framework includes a Plan for Excellence that sets out our strategy to improve our EHSS performance to 2015. Improving efficiency through greater integration
Our Horlicks manufacturing facility near Delhi, India is certified to the international quality standard ISO9001, the environmental standard ISO14001 and the safety standards ISO22000 and OHSAS18001. In 2008, the site introduced an integrated management system to reduce the burden of complying with these separate standards. The new system has improved efficiency and cut costs at the plant by reducing the amount of documentation required and the number of audits. Employees can now just use one instruction manual rather that separate documents for each of the four standards. This project won first place in the 2008 CEO¶s EHS Excellence Awards, Initiative-Health & Safety category.
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Home Responsibility Environmental sustainability Managing EHS and sustainability EHSS vision and policy
Corporate Responsibility Report 2008 EHSS vision and policy Vision GSK¶s environment, health, safety and sustainability (EHSS) vision is to achieve sustainable competitive business advantage and environmental sustainability through leadership and excellence. Our EHSS vision supports our mission to help people do more, feel better and live longer.
Policy Our EHSS policy describes to employees and external stakeholders what we want to accomplish in environment, health, safety and sustainability. It sets out our aspiration of global leadership and excellence and outlines the broad scope of our plans, and how they will be achieved. A revised policy was approved by the Corporate Executive Team (CET) in 2008: Leadership and continuous improvement culture We will be leaders in EHSS performance, protecting the environment and the communities in which we work and enabling healthy motivated employees to be fully engaged with our success. We will maintain a culture of continuous improvement. EHS fundamentals, risk and impacts We will embed EHS fundamentals into the fabric of the business by implementing management systems, EHS governance and risk management practices to address risks and impacts from our facilities, processes, contract research and manufacturing organisations, and suppliers. Sustainability We will integrate sustainability principles into all aspects of our healthcare business by working with our stakeholders, operating within environmentally sustainable limits, lowering our ecological footprint, enhancing social equity and addressing future issues. Open EHSS communication We will be open and transparent with all stakeholders about our efforts to address our EHSS responsibilities and our EHSS performance. The Corporate Executive Team (CET) will ensure risks are tracked until mitigated and that communication of the more significant risks is escalated within the business management structure, as commensurate with the risks and impacts involved. The CET will ensure effective management and involvement of staff with clearly assigned accountability and responsibility.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Managing EHS and sustainability Training and awareness
Corporate Responsibility Report 2008 Training and awareness We provide detailed guidelines and technical information as part of the framework for managing environment, health, safety and sustainability (EHSS). Training and awareness programmes, based on the guidelines, inform employees at all levels about risks, to create a culture where EHSS considerations are integral to the way we do business, and to help employees understand the EHSS issues specific to their jobs. Most EHSS training is managed by the sites and is specific to job roles. EHSS professionals receive induction training and undertake regular training to ensure they are aware of the latest technical information in their fields. Business leaders also receive training so that they understand their responsibilities. In 2008 we reviewed our training programme and found opportunities to improve and standardise EHSS training across GSK in 2009. We will also include EHSS competency as part of the job grading programme for all employees with EHSS responsibilities. Read more about health and safety training. We raise employee awareness of environment, health, safety and sustainability and provide training support materials through our intranet, regular internal publications and events.
myEHSS intranet Our intranet is becoming the primary mechanism to communicate within the company. There are several areas of the GSK intranet that support EHSS including the main site known as myEHSS. myEHSS is the way news about EHSS programmes is shared. It is the source of supporting materials for the framework for managing EHSS such as the policy, standards and guidelines and for training materials and other documents about EHSS. myEHSS is also the basis for the information system with which we collect the data for measuring our EHSS performance and reporting results within GSK and to our external stakeholders. GSK sites use the data to manage their EHSS programmes and risks and to measure their progress.
Publications Our EHSS publications are available electronically and in print. We publish articles on environment, health, safety and sustainability in Spirit, our internal magazine and brief news stories on internal web pages.
Events Our sites participate in Earthweek, an annual, voluntary programme to raise awareness of strategic environmental issues and to encourage integrating environmental concerns into the culture. Held in June to coincide with the World Environment Day, Earthweek encourages employees to think about their impact on the environment. In 2008, over 13,000 employees from 48 sites in 24 countries took part in Earthweek. We sent information kits to all sites to help them develop their own activities including tree planting, clearing litter from a local forest and involving local school children in drawing competitions with an environmental theme. In 2009, operations will be encouraged to continue their voluntary environmental activities but they will no longer be organised centrally.
Awards The CEO¶s EHS Excellence Award website was a vehicle for sharing the innovative EHS practices of sites or teams that won the annual awards. In 2009 this will be replaced by the website supporting the CEO¶s Awards for Sustainability.
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Home Responsibility Environmental sustainability Managing EHS and sustainability Audits and compliance
Corporate Responsibility Report 2008 Audits and compliance Approach
Performance
We regularly audit our operations, contract manufacturers and key suppliers to assess systems to manage risks and impacts, compliance with legislation and implementation of our environment, health, safety and sustainability standards. Audits also assess whether appropriate management systems are in place to improve performance and maintain compliance. Our internal auditors are certified as lead auditors against the ISO 14001 and OHSAS 18001 standards. All GSK manufacturing and R&D sites are audited at least once every four years. The actual frequency is determined by the level of risk and impacts and a site¶s performance at managing those risks. In 2008, we audited 31 sites. In 2006, we began a four-year programme to certify all GSK pharmaceutical and consumer healthcare manufacturing sites to the international environmental standard ISO 14001 and the health and safety standard OHSAS 18001. In 2008, we certified three more sites, bringing the total to 38 per cent of our pharmaceutical and consumer healthcare manufacturing sites certified to ISO 14001. Back to top
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Home Responsibility Environmental sustainability Managing EHS and sustainability Audits & compliance performance
Corporate Responsibility Report 2008 Audits and compliance Approach
Performance
In 2008, we audited 31 GSK sites for implementation of our EHS standards and conducted follow up visits for 17 more. The average score was 78 per cent, the same as 2007. The lowest score we consider to be acceptable is 50 per cent. No site scored below this level with the lowest score at 62 per cent in 2008. Two sites achieved µleadership¶ scores above 90 per cent (three in 2007), while a further 11 achieved scores of at least 80 per cent (14 in 2007). High audit scores indicate good management systems and work practices. Sites that achieve audit scores of 90 per cent or higher are considered to be in a leadership category and receive certificates signed by the Chief Executive Officer. Sites that achieve 80 to 89 per cent receive certificates of achievement signed by their business heads. There were no critical findings related to the environment. These are findings that indicate a high probability of incidents with potentially serious consequences. There were two critical findings related to health and safety. Read about our performance on health and safety issues. The best performance on environmental issues was in waste and water management and sites were generally weakest on assessment of risks for environment, health and safety. Twenty-six of our 78 Pharmaceuticals and Consumer Healthcare manufacturing sites are now certified to both the ISO 14001 and OHSAS 18001 standards (a further four are certified to ISO 14001 only). One Consumer Healthcare R&D site is certified to both standards and one GSK vaccines site and one Pharmaceuticals R&D site are certified to ISO 14001. A further five sites are confirmed for certification audits in early 2009. The certified sites are in Argentina, Australia, Brazil, China, Egypt, France, Germany, India, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Saudi Arabia, Spain, Turkey, the US and the UK. ISO certification is important because it indicates good management systems in place, and sites that have been successfully certified have found the experience beneficial. In order to achieve our 2010 target to certify all pharmaceutical and consumer healthcare manufacturing facilities, we will upgrade the level of management systems implementation. At the same time we will embark on the planned expansion of ISO certification into R&D and vaccines facilities.
Compliance There were no environmental fines or penalties in 2008, continuing our compliance record from 2006 and 2007. However, we remain vigilant to stay in full compliance with all environmental laws and regulations. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Managing EHS and sustainability Reward and recognition
Corporate Responsibility Report 2008 Reward and recognition The CEO¶s EHS Excellence Awards recognise and reward GSK sites that show leadership in EHS and sustainability. They highlight innovation and examples of good practice in EHSS management to share with other sites. Each winner receives a trophy and selects a charity to receive a donation from GSK Both individuals and teams can enter the competition. A shortlist is drawn up by an internal review committee and winners are chosen by a panel that includes experts from academia, government and public interest groups. Awards are divided into three categories: Green Chemistry/Green Technology ± for projects that benefit environment, health and safety through new and efficient chemistry or technology Environmental Initiative ± for programmes that demonstrate improvements in environmental management or performance Occupational Health & Safety Initiatives ± for programmes that demonstrate improvements in health and safety management and performance In 2008 ± the seventh year of the awards ± there were 89 entries from 23 countries and from all GSK businesses. Honours went to eleven projects from Australia, Belgium, India, the UK and the US. Read about winning environmental projects throughout this section and about winning health and safety projects in Our People section. In 2009, the awards will be upgraded to the CEO¶s Awards for Sustainability with new categories and new judging criteria supporting increasing focus on sustainability. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Managing EHS and sustainability Management of EHSS
Corporate Responsibility Report 2008 Management of EHSS Overall responsibility for environment, health, safety and sustainability issues rests with the Corporate Executive Team and the Board. The Chief Executive Officer represents these issues on the Board. The Board Chairman is the champion for GSK¶s climate change programme. The Chief of Staff has operational management responsibility for EHSS on the Corporate Executive Team. The Vice President, Corporate Environment, Health, Safety and Sustainability (CEHSS) has operational responsibility for EHSS, reports directly to the Chief of Staff and has a dotted line reporting relationship to the President of Global Manufacturing and Supply. Environment, health, safety and sustainability activities are overseen by the Risk Oversight and Compliance Council, the Corporate Executive Team and the Audit and Corporate Responsibility Committees of the Board of Directors. These committees regularly review EHSS performance, progress toward meeting EHSS targets and results of EHSS audits of GSK operations and suppliers. They consider issues such as sustainability that have social implications.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability (QYLURQPHQWDOIXQGDPHQWDOV
Corporate Responsibility Report 2008 Environmental fundamentals We have been working to reduce the fundamental environmental impacts of our operations for many years. This involves using treatment and disposal systems to control emissions and wastes from over 80 manufacturing facilities, more than 20 research laboratories, numerous offices and warehouses and a large fleet of vehicles. Our fundamental emissions include: Wastewater General solid and hazardous waste Ozone depleting substances released from our equipment and production processes and when patients use our inhaler products Volatile organic compounds, primarily solvents We aim to create a culture where fundamental environmental considerations are part of everyday business decisions. While we continue to manage fundamental emissions, we are now moving towards sustainability, changing our production and business processes to avoid waste at source rather than simply treating the waste and emissions that arise. Back to top
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Home Responsibility Environmental sustainability Environmental fundamentals Wastewater
Corporate Responsibility Report 2008 Wastewater Approach
Performance
Most GSK sites discharge wastewater to municipal treatment facilities. Some large sites, especially the sites that manufacture active pharmaceutical ingredients (API), have their own on-site wastewater treatment systems. Some sites are permitted to discharge wastewater direct to the sea. We assess the quality of wastewater by measuring the chemical oxygen demand (COD) ± the oxygen required to chemically oxidise compounds in the water. The lower the COD, the cleaner the water. Our target from 2006 is to improve COD levels by three per cent a year per unit of sales which will give us a reduction of 12 per cent by the end of 2010. The vast majority of COD comes from manufacturing of API. Therefore wastewater from µdomestic¶ activities such as washrooms and canteens is only included when it cannot be separated from manufacturing activities.
SGS verified
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Home Responsibility Environmental sustainability Environmental fundamentals Wastewater
Corporate Responsibility Report 2008 Wastewater Approach
Performance
Chemical oxygen demand of wastewater
Targets and performance normalised by sales are based on a constant exchange rate. Any errors found in data from prior years are corrected so data may vary slightly from earlier reports In 2008 our chemical oxygen demand per million sales corrected to a constant exchange rate (CER) decreased 5.7 per cent from a 2006 baseline. Absolute chemical oxygen demand decreased 6.5 per cent from a 2006 baseline to 14.9 million kilograms. This decrease is in line with the target to decrease three per cent per year. Explanation for trend The quality of wastewater discharged is closely related to the types and amount of materials produced in the manufacture of our active pharmaceutical ingredient. Chemical oxygen demand of wastewater decreased significantly in 2007 with the decrease in production of antibiotic ingredients for that year. In 2008 production of these products increased so chemical oxygen demand increased, although it was still less than in 2006. The site that increased antibiotic production accounts for 21 per cent of the wastewater volume and 55 per cent of the wastewater COD. We are concerned about the level of pollution in our wastewater because it can cause a burden to local municipal wastewater treatment facilities or to local receiving water bodies. The changes in levels of wastewater pollution from year to year are due to changes in production, waste minimisation and continued improvements in wastewater treatment. For example, we are evaluating wastewater treatment technologies at our pharmaceutical ingredient manufacturing plant in Singapore and we are planning a reverse osmosis system in our pharmaceutical ingredient manufacturing plant in India. In addition, our work to improve manufacturing efficiency should decrease wastewater pollution in the future. We generated 10.8 million cubic metres of wastewater in 2008 as compared to 10.9 million cubic metres in 2007. The volume of wastewater in 2008 was 1.3 per cent lower than 2007 and 8.1 per cent lower than the 2006 baseline.
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SGS verified
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Environmental fundamentals Waste
Corporate Responsibility Report 2008 Hazardous and non-hazardous waste Approach
Performance
Our production, research and sales activities all produce waste: Production ± hazardous wastes such as solvents and other chemicals R&D and quality control laboratories ± small amounts of chemicals including products and intermediates, as well as broken glassware and plastics Offices ± paper and other standard commercial waste Building renovations produce non-routine waste such as obsolete equipment, office furniture and structural materials We classify waste as hazardous, non-hazardous, and non-routine (for waste such as construction and demolition rubble). A significant proportion of our waste is classified as hazardous because it contains solvents and chemicals used to manufacture active pharmaceutical ingredients. Other hazardous waste we produce includes lubricants, fluorescent lights and carcasses of animals used in research. Most nonhazardous waste is general material such as office waste paper, kitchen waste and non-hazardous substances used in manufacturing.
Our approach We aim to eliminate waste where we can, reduce it if we cannot eliminate it, reuse materials if possible, recycle other waste and dispose of any remaining material sensitively. We separate hazardous wastes into different categories for efficient and appropriate treatment. Regulations vary widely around the world, but our first choice for solvents, which account for most of our hazardous waste, is to reuse or recycle them. Some used solvent is recovered and purified on site and reused in the original manufacturing process and some is sold to commercial reprocessing companies but is still included in our recycling statistics. When reuse or recycling is not possible, solvents are mostly incinerated and the energy recovered wherever possible. We require disposal contractors to comply with our EHS requirements and local regulations. Sites audit their waste contractors or hire consultants to carry out the audits. Our target is to reduce non-hazardous waste disposed per unit of sales by one per cent per annum which will give us a reduction of four per cent by the end of 2010. We have not set a target for reduction of hazardous waste but our target to improve material efficiency, the efficiency with which we convert raw materials to finished products, is designed to reduce hazardous waste. The amount of non-hazardous waste disposed is affected by many factors. The amounts and types of products made in a year can affect not only the amount of waste but also the ability to recycle. In addition to production changes, some sites are actively and aggressively working to recycle as much waste as possible and decrease disposal of waste to minimum levels with focus on eliminating waste sent to landfill. Disposal of hazardous waste is affected by the way solvents are managed and by the mix of products that are made in the year. Most hazardous waste comes from manufacture of active pharmaceutical ingredients, and this is where we concentrate our efforts. We do not collect hazardous waste data from consumer manufacturing plants, laboratories and offices. We estimate that these sites may generate an additional three per cent of hazardous waste to the amount we report.
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SGS verified Building trust through environmental commitment
In 2008, our manufacturing site in Boronia, Australia, stepped up its environmental efforts. CEO Andrew Witty recognised the site¶s achievements by awarding it first prize in the environment initiative category of his 2008 Environment, Health and Safety Excellence Awards. Achievements include: Establishing a µgreen team¶ of employee volunteers that has helped to increase involvement in sustainability activities. As a result the site has reduced water use by 20 per cent from 2007 levels, energy use by 5 per cent from 2007 levels and waste, with 34 tonnes diverted from landfill A 96 per cent reduction in CO 2 emissions from product transport, the result of switching from air freight to sea freight for imports of raw materials and exports of finished goods. This also saved the facility an estimated $A2.9 million (1.3 million GBP) in 2008 and we anticipate these savings will increase to over $A4 million (1.8 million GBP) annually from 2009 onwards Introduction of waste-saving measures to the cold chain distribution system, including reusable cool boxes, data loggers and ice bricks. The new cold chain system manages temperature better, even in extreme conditions. This has prevented 12,000 polystyrene cool boxes and temperature alert tags, and 50,000 disposable ice bricks from being sent to landfill. It also saves our customers the trouble of waste disposal ± all they have to do is repack the equipment and we collect it from them This project won first place in the 2008 CEO¶s EHS Excellence Awards, Initiative-Environment category.
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Home Responsibility Environmental sustainability Environmental fundamentals Waste
Corporate Responsibility Report 2008 Hazardous and non-hazardous waste Approach
Performance
Non-hazardous waste Non-hazardous waste disposed
Targets and performance normalised by sales are based on a constant exchange rate. Any errors found in data from prior years are corrected so data may vary slightly from earlier reports Destination of non-hazardous waste 2008
Targets and performance normalised by sales are based on a constant exchange rate. In 2008 the amount of non-hazardous waste disposed per million sales corrected to a constant exchange rate (CER) decreased 8.5 per cent from a 2006 baseline. Absolute non-hazardous waste decreased 9.2 per cent from a 2006 baseline to 32.9 million kilograms. This is significantly better than the one per cent per year improvement target. Explanation for trend In 2008 the decrease in non-hazardous waste disposed is at least partially due to continuing efforts to
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
manage and recycle waste especially in the pharmaceutical and consumer manufacturing operations. It is also due in part to decreased production of some products. This is partially balanced by increasing waste in the vaccines business as it continues to grow. Our target is specific to non-hazardous waste disposed but we also measure total non-hazardous waste generated which includes both non-hazardous waste disposed and non-hazardous waste recycled. In 2008, we generated 109.4 million kilograms of non-hazardous waste, compared to 120.3 million kilograms in 2007 and 114.7 million kilograms in 2006. Of this, 70 per cent was recycled and 30 per cent was disposed of via landfill or incineration. We reduced disposal of non-hazardous waste at our pharmaceutical manufacturing sites by 22.1 per cent and by 17.9 per cent at our pharmaceutical R&D sites from 2006. However there was a 72.9 per cent increase in non-hazardous waste disposal in our vaccines business due to continuing expansion. This resulted in the overall 9.2 per cent decrease in the amount of non-hazardous waste disposed in GSK compared to the 2006 baseline. We have met our non-hazardous waste improvement target. However, to ensure that we maintain this improvement during times of production increases we will review improvement projects to make sure we continue to reduce the amount of waste we dispose. We are particularly committed to reducing the amount of waste sent to landfill because we want to minimise this burden on the environment and society as landfill space becomes harder to find and the cost of sending waste to landfill increases. These data do not include non-routine waste such as construction and demolition rubble and similar material not related to day-to-day operations. We continue to look for ways to reduce waste and have undertaken waste management reviews at many sites. Recycling non-hazardous waste such as paper, cardboard, glass, plastic or aluminium usually means sending it for reprocessing so it can be reused to make new products. In addition to these waste reduction measures, the reductions are likely to be due to decreases in the volume of production of certain pharmaceutical and consumer healthcare products. As examples of projects that have reduced non-hazardous waste disposal, two sites in India have stopped putting the coal ash they generate into landfill; instead they sell it as raw material for the production of construction material. In addition, three nutritional drink manufacturing sites send some of their process wastes, such as barley husk, for use in animal food while others recycle canteen waste or effluent treatment plant sludge by converting it into bio-compost.
SGS verified
Hazardous waste Hazardous waste disposed
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Targets and performance normalised by sales are based on a constant exchange rate. Any errors found in data from prior years are corrected so data may vary slightly from earlier reports Destination of hazardous waste 2008
Any errors found in data from prior years are corrected so data may vary slightly from earlier reports In 2008 the amount of hazardous waste disposed per million sales corrected to a constant exchange rate (CER) decreased 22.1 per cent from a 2006 baseline. Absolute hazardous waste decreased 22.7 per cent from a 2006 baseline to 54.4 million kilograms. Explanation for trend The decrease in hazardous waste disposed from 2006 to 2008 was due to continued efforts to manage and recycle hazardous waste, especially solvents. It is also due in part to decreased production of some products that used significant quantities of solvent and to outsourcing some production. The amount of hazardous waste disposed is related to the types and quantities of products made and the amount of solvent used by our factories that manufacture active pharmaceutical ingredients. Solvent waste is 92.4 per cent of hazardous waste generated and 98.6 per cent of hazardous waste recycled. The four largest sites that manufacture active pharmaceutical ingredients together account for over 74 per cent of the solvent waste disposed. We did not set a target for reducing hazardous waste disposed. Instead we focused our attention on improving manufacturing efficiency because efficiency improvements will mean less material used in the manufacturing process and therefore less waste. However, efficiency improvements will take some time to achieve. In the meantime, because it is important to minimise hazardous waste, we monitor this and improve the way we handle it, for example by recycling solvents.
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SGS verified
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Environmental fundamentals Contaminated land
Corporate Responsibility Report 2008 Contaminated land Handling practices for some chemicals, used by industries in the past and now no longer followed, caused contamination to land and groundwater. Land can also become contaminated due to accidental release of materials. We are involved in a number of projects in the UK and the US to remediate sites with contaminated land. We have identified five sites in the UK that require some remediation and more than 50 sites in the US. We work with governments and other parties to effect any necessary remediation. Costs of remediation are shared between the parties involved. The five UK sites are undergoing remediation and two are being partially or fully decommissioned. GSK and its heritage companies have spent more than 100 million cleaning up more than 50 sites in the US over the last 20 years. We are continuing to clean up 25 of these sites. Most of them are waste disposal sites where GSK is one of several responsible parties. These figures are not included in the data verification. Explanation for trend When the heritage companies that formed GSK were confronted with a number of contaminated land sites we undertook actions to avoid similar problems occurring in the future. The first action was to audit commercial hazardous waste treatment and disposal sites for their level of performance and financial solvency to avoid inappropriate disposal. The second action was to minimise solvent use wherever possible as we did by changing from solvent coating to aqueous coating of tablets. The third action was to initiate a project to improve material efficiency and to minimise or eliminate hazardous (persistent, bioaccumulative and toxic) compounds. We have also reviewed production operations to determine if past practices have contaminated soil or ground water. Where problems were discovered we initiated site remediation.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Environmental fundamentals Emissions to air
Corporate Responsibility Report 2008 Emissions to air Approach
Performance & plans
Ozone depletion The ozone layer in the upper atmosphere is essential to human survival because it filters out harmful ultraviolet rays from the sun. It has been damaged by ozone depleting substances (ODSs), mainly chlorofluorocarbons (CFCs), hydrochlorofluorocarbons (HCFCs) and halons. The loss of ozone in the upper atmosphere means that more ultraviolet-B radiation reaches the earth¶s surface. This can affect health, for example by causing skin cancer, skin ageing, eye disorders and suppression of the immune system. Industrial use of ODSs was common before their negative effects were realised. In the past, we used CFCs as the propellant gas in most of our metered dose inhalers (MDIs). These deliver a precise dose of medication to treat asthma sufferers and people with chronic obstructive pulmonary disease. The gas is released when patients use the inhalers and a small amount escapes during production. The Montreal Protocol bans the production of CFCs, but it exempts a number of µessential uses¶ which include MDIs. However, in support of its principles we plan to eliminate the use of CFCs from our products by the end of 2010. Less than two per cent of our inhalers now contain CFCs. We have stopped using CFCs as propellants in inhalers made in the US and the European Union. We offer a selection of alternatives in most other countries and will eliminate all CFCs from our products worldwide by the end of 2010. The main alternative propellant used is HFA 134a, a hydrofluoroalkane. This does not affect the ozone layer but does have global warming potential, although significantly lower than CFC, contributing to climate change. We have also invested heavily in dry powder delivery systems that do not use propellants such as CFCs or HFA 134a. These are not suitable for all patients, particularly children and the elderly, as they do not contain propellants and rely on a person¶s lung power for the active ingredients to be administered.
Equipment and production We also use ODSs in some cooling systems and for other ancillary uses at GSK facilities. These are contained inside the systems and are only released in the event of a leak or during maintenance. We have switched to using hydrofluorocarbons (HFCs), ammonia and hydrocarbons. Ammonia does not contribute to either ozone depletion or climate change and hydrocarbons have a small climate change impact. We aim to eliminate CFCs and HCFCs from cooling systems. This is the only way to completely eliminate emissions from equipment. We are focusing on removing larger pieces of equipment from service before the end of 2010. We do not intend to replace equipment containing less than one kilogram of CFCs or HCFCs prior to their planned replacement. This type of equipment tends to be hermetically sealed and is less likely to leak.
Volatile organic compounds Volatile organic compounds (VOCs) react with nitrogen oxides in the presence of sunlight, creating ozone in the lower atmosphere. This results in smog which is a factor in human respiratory illness. Workplace exposure to certain VOCs can also pose a health risk.
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We emit VOCs to the atmosphere mainly from solvents used in our primary manufacturing operations and R&D pilot plants. Solvents are also used to coat some tablets and in cleaning for sterile operations. We use small quantities of solvents in laboratories but do not measure emissions from this use. Our target is to reduce volatile organic compound emissions to air by two per cent per year per unit of sales which will give us a reduction of 8 per cent by the end of 2010.
SGS verified
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Home Responsibility Environmental sustainability Environmental fundamentals Emissions to air
Corporate Responsibility Report 2008 Emissions to air Approach
Performance & plans
Ozone depletion Ozone depletion potential (CFC-11 equivalents)
Targets and performance normalised by sales are based on a constant exchange rate Any errors found in data from prior years are corrected so data may vary slightly from earlier reports CFC-11 has an ozone depletion potential of 1 In 2008 we reviewed the refrigeration equipment inventories for 2006, 2007 and 2008. Where inventories were incomplete they were estimated based on inventories in other years. We also updated the factors for ozone depletion potential and climate change emissions using WMO (World Meteorological Organisation), Scientific Assessment of Ozone Depletion: 2006, Global Ozone Research and Monitoring Project²Report No. 50, 572 pp., Geneva, Switzerland, 2007. (chapter 8). In 2008, estimated ozone depletion potential (ODP) from equipment and production losses per million sales corrected to a constant exchange rate (CER) decreased 82.3 per cent from a 2006 baseline. Absolute ODP from equipment and production losses decreased 82.4 per cent to 5.8 thousand kilograms. This indicates significant progress towards our target to eliminate losses of CFCs and HCFCs from production and equipment. Explanation for trend In 2008, 5.4 thousand kilograms of ozone depleting substance were released during production of inhalers and we estimate that less than one thousand kilograms of CFC-11 equivalent were emitted from equipment. In 2008, 87.7 thousand kilograms of CFC propellant were released when patients used our products. Ozone depletion potential from patient use of metered dose inhalers was 51.9 per cent lower than in 2006. As production of CFC-containing MDIs decreases, the amount of CFC lost during production also declines We maintain a register of the significant pieces of equipment that contain refrigerants and use this register to track progress towards the target to eliminate CFCs and HCFCs from refrigeration equipment. We have 162 pieces of equipment containing CFCs, amounting to 10,238 kilograms in total. Over 6,774 items of
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p q p g g g equipment contain other ODSs, with an ODP of 16,468 kilograms of CFC-11 equivalent. We estimate (using an estimation factor of 2.75 per cent from the British Refrigeration Association) that 468 kilograms CFC -11 equivalent were released from equipment in 2008. We are making progress towards our target and expect that we will achieve it.
SGS verified
Volatile organic compounds Volatile organic compound emissions
Targets and performance normalised by sales are based on a constant exchange rate Any errors found in data from prior years are corrected so data may vary slightly from earlier reports In 2008 the amount of volatile organic compound released to air per million sales corrected to a constant exchange rate (CER) decreased 9.7 per cent from a 2006 baseline. Absolute volatile organic compound emissions decreased 10.4 per cent from a 2006 baseline to 3.9 million kilograms. This is better than our two per cent per year target. Explanation for trend Emissions of VOC to air are affected by the management of solvents and by the mix of products that are made in the year. In 2008 we decreased production of several products that used significant quantities of solvent and we outsourced several steps of one product. It is important to reduce emissions of VOC because it benefits the environment, society and GSK. We want to reduce these emissions even in high production years so we continue to identify projects to reduce emissions. In 2008 one site installed a carbon absorption unit to reduce emission of solvents and two more sites have emission reduction projects planned for 2009. We anticipate achieving our target.
Our plans Our material efficiency projects are expected to reduce the amount of solvent used and we should see the effects of this work in reduced solvent emissions in the future. In the meantime we continue to look for ways to reduce solvent use and increase recycling to achieve our target of a two per cent annual reduction in emissions resulting in eight per cent improvement by the end of 2010. Two of our sites that manufacture active pharmaceutical ingredients have projects planned for 2009 to control emissions.
SGS verified
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Home Responsibility Environmental sustainability Environmental fundamentals EHSS in business processes
Corporate Responsibility Report 2008 EHSS in business processes Here we describe how we are embedding environment, health, safety and sustainability (EHSS) principles into our business processes.
New product development and supply Our EHSS Milestone Aligned Process helps scientists identify and address environment, health, safety and sustainability issues during new product development and supply activities. It ensures that: Scientists understand environment, health, safety and sustainability impacts and how they should be managed throughout a product¶s life-cycle New products and processes are developed that do not harm people, property or the environment Opportunities are identified, such as process efficiencies and elimination of waste that reduce environment, health, safety and sustainability impacts and improve product development and supply
Acquisitions and divestitures Our due diligence process for acquiring and divesting businesses ensures that environment, health, safety and sustainability issues are considered in contract negotiations and that adequate management systems are in place. We work with acquired companies to develop action plans to align their EHSS practices with GSK¶V
Emergency response and crisis management The discovery, development and manufacture of pharmaceutical and consumer products involve the use of hazardous materials and processes. All sites incorporate emergency response and crisis management programmes into their management plans. These programmes ensure that accidents are effectively managed when they occur and that any impact on our business, the local community and the environment are minimised. Each site conducts an annual review of its internal emergency response programmes and technical capabilities and develops action plans to address any areas needing improvement.
Procurement Our procurement activities support our environment, health, safety and sustainability (EHSS) goals in the following areas: Sourcing renewable and recycled materials where appropriate Choosing safe and energy-efficient equipment Managing EHSS risks in our supply chain Our capital project technical review process ensures that we consider environment, health, safety, security and loss prevention in the design of new facilities and processes. By identifying EHSS issues early in a project, we can engineer facilities and processes that are efficient and safe for workers and the environment while still being cost effective. Read more about EHS and procurement. Back to top
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Home Responsibility Environmental sustainability Environmental fundamentals Supplier performance
Corporate Responsibility Report 2008 Supplier performance We want to understand the total environmental footprint of the processes used to make our products. This means measuring the impacts of our suppliers of active pharmaceutical ingredients and packaged products, as well as those from our own operations. Some of our improvements in hazardous waste and air emissions were due to outsourcing of some production processes. Until we can collect data from our suppliers we will not know the full impact of production of our products. In the future we hope to report on the combined environmental impacts of manufacturing at GSK facilities and at our contract manufacturers. GSK selects suppliers with an appropriate level of EHS management systems control. However, over the past few years it has proved difficult to obtain environment, health and safety performance data from these suppliers just for the products that they manufacture for GSK. In 2007 we surveyed 52 suppliers and received a response from 21 (40 per cent). They indicated that they preferred providing data after the first quarter of the year to give them time to review it. With this input from our suppliers we changed our process. For energy data we will join the Carbon Disclosure Project (CDP) supplier initiative and request energy and climate change data from our large suppliers through the CDP. We will collect 2008 water, waste and injury and illness data from suppliers during the second quarter of 2009 using our electronic system. We published the 2007 data in our 2007 corporate responsibility report and will publish 2008 data in the 2009 report. Read more about GSK¶s supply chain.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Sustainability
Corporate Responsibility Report 2008 Sustainability Traditional environmental programmes focus on managing wastes after they are generated by business processes. Sustainable practices change the business processes themselves to consume less natural resource, switch to renewable materials, protect biodiversity, generate less waste, eliminate waste that is persistent, toxic or bioaccumulative and lower costs. This approach benefits the environment, society, GSK and future generations. Our high priority sustainability issues are: Manufacturing efficiency ± reducing the amount of raw materials needed to produce a finished product Climate change ± reducing the climate impacts of our buildings, equipment, transport and products Water ± reducing the amount of water we use Product stewardship ± reducing the use of materials of concern and the environmental impacts of our products after use by the patient Packaging ± reducing the amount of packaging we use and using recyclable and recycled materials Back to top
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Home Responsibility Environmental sustainability Sustainability Materials efficiency
Corporate Responsibility Report 2008 Materials efficiency Approach
Performance
We aim to increase the efficiency with which we convert raw materials to finished products. Known as materials efficiency, this helps reduce the resources we use, the waste we generate and the cost of production. Pharmaceutical processes are often complex, usually requiring large amounts of solvents and other raw materials. Typically, the industry uses more than 100 tonnes of material for every tonne of active pharmaceutical ingredient (API) produced. We have set a target to double the average materials efficiency of manufacturing processes for new products introduced between 2006 and 2010.
Process design Process design is essential to minimising environmental impacts. It determines which chemicals and processes are used in manufacturing as well as the impacts from production waste. The EHS team works with process development teams to incorporate EHS considerations into process design and materials sourcing, and to identify potential EHS risks in manufacturing. New manufacturing technique cuts energy and waste
Our R&D facility in North Carolina has developed a novel way to manufacture a diabetes drug, currently in phase ll clinical trials, cutting environmental impacts and costs. This replaces a production method that was too resource-intensive to use on a large scale. The chemical development department found a way to synthesise the molecule more efficiently and then produce it at a yield 37 per cent greater than before. The new process uses fewer raw materials, less than half the energy and 81 per cent less solvent. It also produces around 30 per cent less wastewater. The new process will save over 110 million each year in raw material and waste disposal costs. This project won first place in the 2008 CEO¶s EHS Excellence Awards, Green Chemistry and Technology category
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Home Responsibility Environmental sustainability Sustainability Materials efficiency
Corporate Responsibility Report 2008 Materials efficiency Approach
Performance
Mass productivity
The chart shows how we improve materials efficiency as compounds move through development stages. In the early stages almost all compounds are less that one per cent materials efficient. By the last stage most achieve more than two per cent and some are above three per cent, with one process achieving productivity of 4.9 per cent. Explanation for trend Improving manufacturing efficiency is one of the most important ways we can address sustainability and meet some of our fundamental environmental targets such as reducing our disposal of waste and emissions to air. This will not be easy because the chemical processes that make our medicines can be complex. In spite of the difficulties, we remain committed to improving efficiency for new products. In 2009 we will review the production processes that are transferred to manufacturing to determine if additional improvements are possible so that we can achieve our target.
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Home Responsibility Environmental sustainability Sustainability Climate change and energy
Corporate Responsibility Report 2008 Climate change and energy Approach
Performance & plans
It is widely acknowledged that human activity, primarily burning fossil fuels to produce energy, is contributing to climate change. The Intergovernmental Panel on Climate Change (IPCC), the world¶s leading climate authority, has stated that urgent action is needed to avoid the effects of dangerous climate change, including more frequent extreme weather events such as droughts, floods and hurricanes. We want to be part of the solution to climate change and are committed to reducing our impact. As well as benefiting the environment, taking action on climate change helps us cut costs, improves our reputation with stakeholders and helps us prepare for future legislation on emissions. Read about our energy and climate change position
Our climate change programme In 2007, following the fourth assessment report of the Intergovernmental Panel on Climate Change, we launched a new climate change programme and committed to new targets. This includes a commitment to reducing our climate change impact (CO 2 equivalent emissions) and energy use in operations and transport from 2006 levels by 20 per cent per unit of sales (based on a constant exchange rate) by 2010 and by 45 per cent by 2015. This replaced our 2006 target to reduce energy use by one per cent per year, normalised by sales. We will achieve our new targets by: Making our buildings and equipment more energy efficient Installing onsite renewable technologies such as wind turbines and photovoltaic panels Buying electricity produced from renewable sources Reducing the climate impact of travel and transport by switching from air to sea freight and by transporting more per load to reduce the number of journeys needed The Corporate Executive Team has approved a central fund to help finance these energy saving projects. The Climate Change and Energy Reduction team consulted with GSK businesses to identify potential energy saving projects. In 2008, 171 projects were completed which are expected to result in a saving of more than 153,000 Kwh (550,800 GJ) of energy per year and more than 40 thousand tonnes of climate change emissions. Product climate impact We are also researching ways to minimise the amount of greenhouse gases released when our propellant inhaler products are used by patients for asthma and chronic obstructive pulmonary disease. These account for two-thirds of our climate impact. Propellant inhalers contain either hydrofluoroalkanes (HFAs) or chlorofluorocarbons (CFCs) which ensure a consistent dose but HFAs are 1,400 times more damaging to the climate than CO2 and some CFCs are more than 10,000 times more damaging to the climate than CO2. CFCs also deplete the ozone layer.
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SGS assurance logo Back to top
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Home Responsibility Environmental sustainability Sustainability Climate change and energy Performance and plans
Corporate Responsibility Report 2008 Climate change and energy Approach
Performance & plans
GSK¶s carbon footprint
Other includes climate change impact from greenhouse gases released from cooling systems, during the production of inhaler products, from wastewater treatment and other processes. Any errors found in data from prior years are corrected so data may vary slightly from earlier reports Climate change impact from operations energy and transport
Targets and performance normalised by sales are based on a constant exchange rate
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Any errors found in data from prior years are corrected so data may vary slightly from earlier reports We use the Greenhouse Gas Protocol for all of our calculations of CO 2 emissions from energy use. We also updated the factors for climate change emissions from propellants and refrigerants using WMO (World Meteorological Organisation), Scientific Assessment of Ozone Depletion: 2006, Global Ozone Research and Monitoring Project²Report No. 50, 572 pp., Geneva, Switzerland, 2007. (chapter 8) In 2008, our carbon footprint was equivalent to 7.0 million tonnes of CO 2 compared to 7.3 million tonnes in 2006. The majority of our emissions come from the use of inhalers by patients with respiratory disease. A decrease in the use of CFC inhalers with a simultaneous increase in the use of HFA inhalers meant that our climate change emissions from patient use of inhalers did not change significantly from 2006 to 2008, remaining at 4.7 million metric tonnes of CO 2. If we exclude the use of inhalers, our carbon footprint reduced from 2.6 million tonnes of CO 2 in 2006 to 2.4 million tonnes in 2008, reflecting emissions of greenhouse gas from inhaler manufacturing which decreased from 0.5 million tonnes in 2006 to 0.3 million tonnes in 2008. Explanation for trend We recognise that our products have more of a climate change impact than our energy consumption so our R&D scientists are working to develop alternatives to HFA as a propellant for all candidate inhaled products.
Emissions from operations energy and transport Our CO 2 emissions from operations energy and transport per million sales corrected to a constant exchange rate increased 1.6 per cent from a 2006 baseline. Absolute climate change emissions increased less than 1 per cent from a 2006 baseline to 2.1 million tonnes. This was due to increased energy use in the growing vaccines business which overshadowed the energy savings in our pharmaceutical and consumer manufacturing operations, and to an increase in the use of coal in India. Our energy use from operations and transport on which these CO 2 emissions are based, decreased less than one per cent from 2006 to 2008 to 24.3 million gigajoules.
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Energy performance Energy consumption (facilities and processes)
Targets and performance normalised by sales are based on a constant exchange rate Any errors found in data from prior years are corrected so data may vary slightly from earlier reports
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Seventy-nine per cent of our energy use is attributed to energy for operations (facilities and processes). In 2008 our energy use per million sales corrected to a constant exchange rate (CER) increased less than one per cent from a 2006 baseline. Absolute energy use decreased less than one per cent from a 2006 baseline to 19.2 million gigajoules. This is equivalent to the energy used by over 200,000 UK households. Explanation for trend We set aggressive targets to reduce energy use and related climate change emissions and are moving towards these although progress is slower than expected. If we continue on the present course we expect to achieve an improvement of eight per cent per unit sales by 2010. We have taken steps to accelerate the implementation of energy reduction projects such as diverting more engineering resources to support them. We also expect projects initiated in 2008 will begin to deliver energy and carbon savings in 2009 that will then be sustained. In addition, business changes such as site closures resulting in more efficient use of existing facilities may help us achieve the target. We therefore remain committed to the 2015 target of a 45 per cent improvement. Energy use decreased more than four per cent in the pharmaceutical and consumer manufacturing organisation and the pharmaceutical R&D organisation. However it increased more than 30 per cent in the vaccines organisation due to continuing growth with additional and enlarged buildings and new products. Our pharmaceutical and consumer manufacturing, our vaccines manufacturing and research group and our pharmaceuticals R&D group accounted for 54 per cent, 15 per cent, and 25 per cent of energy use respectively. Between 2001 and 2006 our energy efficiency programme achieved incremental gains in energy efficiency by focusing on operational changes. These included optimisation of equipment use, resetting thermostats and changing to energy efficient lighting. Since 2006, some parts of our business continued to make incremental gains in energy efficiency but growth in our vaccines business and the associated increases in energy use partially offset these efficiency gains. In mid-2007 we revised our climate change programme to include more challenging targets covering energy for operations (facilities and processes) and transport of products and employees. A fund was set up to encourage energy projects. More than 400 potential projects were identified for support from this fund in 2007 and in 2008 171 projects were completed with more than 15 million spent. These projects are expected to save 153 million kilowatt hours of energy and 40 thousand metric tonnes of climate change emissions. The majority of projects were completed towards the end of 2008 so the full benefit of these projects will not be realised until 2009. We are currently working on a further 157 projects and a significant proportion of these will be completed during 2009. Around 75 projects that were identified for support in 2007 and 2008 were abandoned following more detailed investigations to determine their business benefit.
Our plans In 2008 GSK identified more than 600 potential projects for support from our climate change fund and our pharmaceutical and consumer healthcare manufacturing business has created a Centre of Excellence to support the implementation of these projects during 2009. In particular, emphasis will be given to implementing combined heat and power (CHP) projects. CHP is the simultaneous generation of usable heat and power, usually electricity, in a single process. Typically CHP uses a gas turbine, an engine or a steam turbine to drive an alternator to produce electricity. The heat produced is recovered, usually in a heat recovery boiler, to provide steam, hot water or even cooling with the right equipment. Because CHP systems use the heat produced during the electricity generation process, they can achieve overall efficiencies in excess of 70 per cent at the point of use. Conventional power plants have efficiencies of less than 50 per cent because the excess heat which they generate is normally wasted and additional losses occur during transmission and distribution. Another key area of focus will be to identify energy saving opportunities associated with heating, ventilation and cooling (HVAC). This equipment is needed to maintain the correct environmental conditions within our production areas so we can manufacture our products. However, it is responsible for more than 50 per cent of the operational energy that we consume. Energy reduction has also been identified as a key objective for this business and in 2009 the remuneration of senior managers will be linked to the achievement of energy reduction targets. Energy consumption has also been identified as a key business metric that will be tracked throughout 2009 by the Corporate Executive Team.
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Using canal water for sustainable cooling
In December 2008, GSK unveiled an energy-saving scheme in partnership with British Waterways, the organisation in charge of the UK¶s canal network. Under the initiative, GSK House in Brentford will use water from a nearby canal, rather than more energy-intensive air conditioning, to cool its computer data centres. This will reduce carbon dioxide emissions by around 920 tonnes per year. It will also lower energy bills by 100,000 annually, recovering the costs of the project within five years.
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Home Responsibility Environmental sustainability Sustainability Climate change and energy Climate change emissions since 1990
Corporate Responsibility Report 2008 Climate change emissions since 1990 For GSK, climate change emissions from inhaler products are significantly greater than the climate change emissions from operational energy and transport. Our climate change emissions increased 86 per cent from 1990 to 1998 as sales of inhalers with chlorofluorocarbon (CFC) propellants increased. Phase out of CFC propellants began as a result of the Montreal Protocol which aimed to eliminate ozone depleting compounds (CFCs have an impact on both ozone depletion and climate change). As these were replaced with inhalers using hydrofluoroalkane (HFA) propellants or with dry powder inhalers that do not use propellants, climate change emissions improved dramatically because HFAs have much lower climate change impact than CFCs. Currently with 98 per cent of inhalers either using HFA propellants or being dry power propellant-free inhalers, climate change emissions are 64 per cent lower than 1990 levels. These emissions are expected to grow in the coming years as sales of inhalers with HFA propellants continue to grow. The emissions from inhalers and energy back to 1990 were estimated based on energy and CFC data in public reports back to 1993 for heritage SmithKline Beecham and to 1996 for heritage GlaxoWellcome. Where actual data for inhalers and energy were not available, sales data were used with factors applied to estimate climate change emissions. Climate change emission factors for CFC and HFC have been revised over the years and we used the current factors from the World Meteorological Organisation published in 2007. Global warming potential from energy, transport and inhaler use
http://www.epa.gov/ozone/science/ods/classone.html WMO (World Meteorological Organisation), Scientific Assessment of Ozone Depletion: 2006, Global Ozone Research and Monitoring Project²Report No. 50, 572 pp., Geneva, Switzerland, 2007. (chapter 8) Explanation for trend When the Montreal protocol called for the elimination of CFCs because of their effect on the ozone layer we invested over 1 billion to develop alternatives including devices that use HFA as a replacement propellant. HFA has no ozone depleting potential and it has a lower effect on climate change than CFC. Therefore, as CFC propellants were phased out and HFA phased in, there was a significant decline in the climate change impact from products. We estimated our climate change emissions back to 1990, and calculated an improvement of over 60 per cent by 2008. This compares to the 12.5 per cent reduction that the Kyoto protocol requires for the UK from 1990 to 2012. The Kyoto protocol does not include climate change emissions for CFC but it does include HFA. Back to top
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Home Responsibility Environmental sustainability Sustainability Climate change and energy Emissions trading
Corporate Responsibility Report 2008
Emissions trading A number of our UK sites participate in the UK government¶s voluntary Climate Change Agreement programme which provides companies with energy tax rebates if they meet agreed energy-efficiency targets. In 2008 GSK reported its compliance with these agreements and all participating GSK sites were found to comply with their Climate Change Agreements. Several GSK sites participated in the European Union Emissions Trading Scheme (EU ETS). Collectively these sites emitted below their specified CO 2 allowances, generating a surplus of carbon credits. Proceeds from the sale of carbon credits are invested in energy-saving projects. Back to top
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Home Responsibility Environmental sustainability Sustainability Climate change and energy Transport impact
Corporate Responsibility Report 2008 Transport impact In 2008, we estimate that transport of our products and employees accounted for 361 million kilograms of CO 2, compared to 363 million kilograms in 2007. This was equivalent to about 17 per cent of our climate change impact from energy. Our travel-related CO 2 emissions consisted of: Business air travel (34 per cent) Global sales fleet (32 per cent) Transport of products from manufacturing plants to distributors (34 per cent), most of which was by air freight (82 per cent). Our options for reducing the impact of transporting products include: Consolidating freight shipments Reducing the number of shipping points Making more use of round tripping (managing inbound freight trucks so they do not return empty) Switching from air to sea transport where possible
Travelling to work We have µgreen travel plans¶ at a number of sites to encourage employees to reduce the environmental impact of their travel to work. For example, at GSK House in Brentford, UK, reserved parking spaces are given to car-sharers and drivers of fuel-efficient cars. We provide changing rooms and showers for cyclists, as well as discounts for bicycle equipment and repairs. At our Philadelphia office the cost of public transportation is subsidised.
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Home Responsibility Environmental sustainability Sustainability Water use
Corporate Responsibility Report 2008 Water use Approach
Performance & plans
Clean water is a valuable resource that needs to be conserved and protected from pollution. We aim to minimise the amount of water we use and the environmental impact of the water that we discharge. GSK uses water in manufacturing (for processes, products, cooling and cleaning) and for general site uses, including drinking, food services and sanitation. Sites that manufacture active pharmaceutical ingredients use large amounts of water, while R&D sites and offices use less. Our water standard requires sites to minimise water use, reuse water whenever feasible and ensure that all wastewater is treated and discharged in a way that minimises adverse environmental impacts. Our target is to reduce water consumption by two per cent per annum per unit of sales which will give us an eight per cent water saving by the end of 2010.
SGS verified
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Home Responsibility Environmental sustainability Sustainability Water use
Corporate Responsibility Report 2008 Water use Approach
Performance & plans
Water consumption
Targets and performance normalised by sales are based on a constant exchange rate Any errors found in data from prior years are corrected so data may vary slightly from earlier reports In 2008 the amount of water used per million sales corrected to a constant exchange rate (CER) decreased 10.6 per cent from a 2006 baseline. Absolute water use decreased 11.4 per cent from a 2006 baseline to 19.7 million cubic metres. This is significantly better than the two per cent per year target. Explanation for trend Most of this reduction was achieved through maintenance at facilities and process changes. Smaller improvements were achieved through ongoing conservation measures, particularly at water -stressed locations. For example, our pharmaceutical manufacturing plant in Boronia, Australia, located in a water stressed area, has an ongoing campaign to save water. Since 2001 they have reduced water usage by 33 per cent while increasing production by 22 per cent and staff by 30 per cent, saving an average of 29 million litres of water a year. These water savings are accomplished by recovering wastewater and using it in cooling towers, amenities and maintenance, by capturing storm water and by communicating with employees about saving water. We believe we will achieve our target.
Our plans GSK has endorsed the UN Global Compact¶s CEO Water Mandate. The UN estimates that more than 1 billion people do not have access to clean water and 2.6 billion people lack the basic sanitation necessary for health and well-being. Water stress is expected to worsen in many parts of the world as a result of factors including urbanization and population growth, increasing food production, changing consumption patterns, industrialization, water pollution, and climate change. We joined the mandate because we recognise that water is an important and valuable resource that needs to be managed responsibly and we are committed to taking action by developing a comprehensive approach in the six areas identified in the mandate: Direct Operations; Supply Chain and Watershed Management;
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Collective Action; Public Policy; Community Engagement; and Transparency. In many of these areas we have already taken some action. For example we have targets for water conservation and we reported water usage from our own operations. We have plans in place to collect and report water usage from a sample of key suppliers. We work with local communities to conserve water and preserve wetlands and we educate our employees in water conservation. We understand the connection between water and public health and have a philanthropic project known as PHASE to educate people in developing countries about the importance of hand washing. To meet the requirements of the Mandate we will build on these and other existing efforts and manage them under a single programme. During 2009 a Team with representatives from across the business will be formed to determine key priorities and objectives.
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Home Responsibility Environmental sustainability Sustainability Product stewardship
Corporate Responsibility Report 2008
Product stewardship We take the environment into account across the entire lifecycle of our products. This begins with process design and continues through manufacturing to use by patients and eventual disposal. Some of our wastes such as used solvents can be reused as a raw material for another industry such as paint stripping (cradle to cradle). In this section we focus on several aspects of product stewardship: Pharmaceuticals in the environment Some portion of active pharmaceutical ingredients, the substances that make medicines work, may eventually be excreted by humans and enter the environment. We conduct tests and risk assessments to evaluate the potential effects of our pharmaceutical products on the environment. Materials of concern Materials of concern are chemicals where scientific evidence shows probable serious long-term effects to humans or the environment and for which there is existing or potential future legislation that may restrict use. Our process development teams develop strategies to eliminate or substitute the use of these materials. Genetically modified organisms We use genetically modified organisms (GMOs) in the research and development of new therapeutic agents and in the manufacture of certain medical products such as vaccines. All our work with GMOs is controlled to the strictest national and international regulations, and we apply best practice across all our facilities. REACH In 2008, we continued to work to reduce risks to continuity of supply of chemicals presented by the introduction of the EU¶s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation. Global harmonisation We continue to prepare for impending changes to classification and labelling of hazards as part of the UN¶s Globally Harmonised System for Classification and Labelling of Chemicals regulation.
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Home Responsibility Environmental sustainability Sustainability Product stewardship Pharmaceuticals in the environment
Corporate Responsibility Report 2008 Pharmaceuticals in the environment Some portion of active pharmaceutical ingredients (APIs), the substances that make medicines work, may eventually be excreted by humans and enter the environment. Wastewater treatment removes most pharmaceutical residues but small concentrations do end up in rivers or in the sea and very low concentrations of some pharmaceuticals are occasionally found in drinking water. In countries where wastewater is not treated, higher concentrations may enter the environment. We conduct tests and risk assessments to evaluate the potential effects of our pharmaceutical products on the environment. To date these indicate that our products do not appear to pose a risk for humans or the environment based on current risk assessment methodologies and information. We conduct retrospective analysis of environmental data to refine our testing methodology and assessment models. We recently revised our material testing strategies to include chronic testing (to determine the impact of our products on the environment over the long term) and mode of action analysis (to identify the most sensitive species), to meet new regulatory guidelines and to improve our understanding of possible environmental effects. We are committed to transparency about the data we collect and make environmental data publicly available. Assessments and environmental data for individual APIs are provided online in Safety Data Sheets. Data are also available on the Swedish Doctors Prescribing Guide (see below). We make information about pharmaceuticals in the environment available to the public by publishing the results of our risk assessments in scientific journals. Read our public position statement about pharmaceuticals in the environment. In the EU and US, environmental risk assessments are part of the approval process for producing and marketing new medicines. They allow regulatory agencies to assess the potential for environmental impacts of drugs pending approval. We work with regulatory agencies to ensure that the potential environmental impacts of our pharmaceuticals are understood and minimised. We continue to monitor the latest scientific studies and findings to improve our risk assessment methodology. In addition, we conduct and contribute to environmental research in this area. We recently completed a study and submitted a scientific paper assessing the potential impacts on human health from environmental exposures for around 35 APIs included in GSK pharmaceuticals. We are also beginning to study the possible impacts of mixtures of various compounds in household wastewater at extremely low concentrations, which include our pharmaceuticals as well as other pharmaceuticals and household products. Although the main source of pharmaceuticals in the environment is patients excreting medicines they have taken, GSK has established limits for active pharmaceutical ingredients in wastewater from our manufacturing sites. Based on our studies, we establish safe levels for API, based on a demonstration of no risk. We assess process waste concentrations against these established levels and treat the wastewater if required to ensure that the safe levels are achieved so that there is no subsequent environmental risk. Industry collaboration We work with other pharmaceutical companies, universities and research groups on activities around pharmaceuticals in the environment. We also collaborate on joint projects with industry groups and sponsor academic studies. For example, we submit environmental data on our products as part of the Swedish classification system for pharmaceuticals, a collaboration between the Swedish Pharmaceutical Association and the Swedish government. This is a voluntary transparency initiative making information about
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environmental risks available to the public, doctors and scientists. We participate in technical working groups on pharmaceuticals in the environment sponsored by the industry group Pharmaceutical Research and Manufacturers of America (PhRMA). Through PhRMA and the Association of the British Pharmaceutical Industry, we continually engage with regulatory scientists from the US Environmental Protection Agency, the US Food and Drug Administration and the UK Environment Agency.
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Home Responsibility Environmental sustainability Sustainability Product stewardship Materials of concern, GMOs and nanomaterials
Corporate Responsibility Report 2008 Materials of concern, GMOs and nanomaterials Materials of concern Materials of concern are chemicals where scientific evidence shows probable serious long-term effects to humans or the environment and for which there is existing or potential future legislation that may restrict use. These compounds include so called PBTs (substances that persist in the environment, bioaccumulate in animals and plants or are toxic to life), carcinogens, mutagens, reproductive toxins, substances known to cause asthma, endocrine disrupting chemicals and ozone depleting substances. Our EHS team works with our process development teams to help them develop strategies to eliminate or substitute the use of thesematerials. Read our position paper on hazardous chemicals management. Performance In 2008, we used 56 metric tonnes of materials of concern, 95 per cent of which was accounted for by five solvents. Most of the solvent waste from this production was destroyed by incineration, although some of it was recycled as part of the work in our pilot plants. We also examined the use of materials of concern across all phases of development. This determined which substances are being used and identified how they can be replaced during development.
Genetically modified organisms We use genetically modified organisms (GMOs) in the research and development of new therapeutic agents and in the manufacture of certain medical products such as vaccines. We use GMOs to identify the genetic targets and causes of disease and to develop new antibiotics and drugs for conditions such as heart disease, diabetes and depression. We use a number of different GMOs, predominantly harmless organisms such as disabled strains of the bacterium E.coli and eukaryotic cells in culture. We also manufacture a number of products that are derived from genetically modified materials, such as hepatitis B vaccine. We do not produce or plan to produce any products that are, or contain, viable organisms. All our work with GMOs is controlled to the strictest national and international regulations, and we apply best practice across all our facilities. Any work with GMOs is subject to full risk assessment, ensuring safe use, storage and disposal. All processes are performed in closed vessels minimising the risk of release. The large-scale fermentation or propagation of GMOs is always undertaken in fully contained systems. Research is performed in containment laboratories appropriate to the risk of the materials handled. Work is controlled by written procedures, and we carry out regular maintenance checks. We treat all waste from our GMO operations to ensure we do not release viable GMOs from our contained processes into the environment. All GMOs are deactivated prior to disposal by chemical or heat treatment. We do not routinely undertake research and development involving the cultivation of genetically modified plant species.
Nanomaterials Nanotechnology is an area of science that involves controlling nanomaterial which are materials that are on an atomic or molecular scale. Nanotechnology may in future be used to develop new medicines.
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We have participated in a Responsible Nano Code consultation for the development of a code of conduct for businesses that use nanotechnology. Responsible Nano Code is a collaboration between the Royal Society, Insight Investment and the Nanotechnology Industries Association. We estimate that we will not begin using nanotechnology until around 2011.
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Home Responsibility Environmental sustainability Sustainability Product stewardship REACH
Corporate Responsibility Report 2008
REACH In 2008, we continued to work to reduce risks to continuity of supply of chemicals presented by the introduction of the EU¶s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation. This involved: Using site inventories from EU and international sites to identify any chemicals sourced from EU suppliers or imported or manufactured by GSK Contacting companies that supply GSK with chemicals covered by REACH to assess their plans for management of potential risks to continuity of supply to GSK. This involved the evaluation of over 1,000 suppliers Pre-registering any phase-in material manufactured or imported by GSK in volumes of more than one tonne per year Registering any new substances we manufacture or import in volumes of less than one tonne per year Read about our position on REACH on gsk.com
Our plans From 2009 we will start to gather information about use of materials and EHS hazard data required to meet the first REACH registration milestone of November 2010 for phase-in substances. We will also continue to work with our suppliers to ensure that they meet their REACH obligations and will collaborate with other companies via Substance Information Exchange Forums (SIEF) to share any hazard data we have on substances of mutual interest that require REACH registration.
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Home Responsibility Environmental sustainability Sustainability Product stewardship Global harmonisation
Corporate Responsibility Report 2008 Global harmonisation We continue to prepare for impending changes to classification and labelling of hazards as part of the UN¶s Globally Harmonised System for Classification and Labelling of Chemicals (GHS) regulation. This includes: Changing the way we produce safety data sheets to ensure compliance Initiating the process of reclassifying all substances we manufacture or import following GHS rules Developing training for employees on new hazard warning symbols and labels introduced as part of GHS Read our position paper on hazardous chemicals management.
Our plans During 2009 we will work with GSK operations to evaluate hazard labelling solutions that will facilitate production of GHS compliant labels based upon the revised classifications being developed.
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Home Responsibility Environmental sustainability Sustainability Packaging
Corporate Responsibility Report 2008 Packaging We are working to reduce the environmental impact of packaging for our pharmaceutical and consumer healthcare products. Our µgreen packaging guide¶ provides guidance for evaluating and selecting packaging. It allows designers and managers to benchmark new and existing packaging designs using five metrics: Manufacturing impacts Mass of the material Biodegradability PVC content Resource depletion of petrochemical feedstocks One example of reducing the impact of our packaging is the use of 100 per cent recycled plastic for our Ribena bottles, achieved despite the challenge of sourcing sufficient quantities of recycled plastic. Ribena packaging
Our Nutritionals business has embedded sustainability into every aspect of its business as evidenced by the work done on Ribena. We work on biodiversity with the farmers that grow our berries, we work towards a goal of µzero waste to landfill¶ from manufacturing Ribena and we use 100 per cent recycled materials for our bottles. From these actions we have realised the benefits of sustainability, benefits to the environment, our customers and our business. The work done on bottling is just one example of our approach. We produce hundreds of millions of bottles of Ribena and Lucozade a year. The bottles are made from a type of plastic known as PET. We estimate that packaging such as this can form as much as 60 per cent of our Nutritional Healthcare products¶ environmental impact. In 2008 we launched the UK and Europe¶s first 100 per cent recycled and recyclable drinks bottle, for our Ribena squash and ready-to-drink products. Previously we had packaged Ribena in a bottle made from 40 per cent recycled material. In 2008 we filled over 125 million of the new bottles with Ribena. By using 100 per cent recycled material, we avoided the emission of 8,000 tonnes of CO 2 and prevented a total of 3,500 tonnes of waste from being sent to landfill. The bottles can also be recycled by consumers after use. We are trying to understand what would make people recycle when they are away from home by trialling µreverse vending machines¶ at major shopping centres. People can put used drinks bottles into the machines, which crush and compact them ready for collection and recycling. The new bottles contribute towards our targets for GSK Nutritional Healthcare products to use 25 per cent less packaging, and use packaging made from an average of 50 per cent recycled materials by 2010. This project won The Vanguard Award in the 2008 CEO¶s EHS Excellence Awards
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Home Responsibility Environmental sustainability Open and transparent relations
Corporate Responsibility Report 2008 Open and transparent relations We aim to be transparent and open about the environmental impacts of our products and processes. This helps us build trust with our stakeholders and provides assurance that we are managing environment, health, safety and sustainability (EHSS) risks. We report our progress against our EHSS objectives in our annual corporate responsibility report and respond to specific requests for information throughout the year. We also engage more formally with stakeholders to gather feedback on our approach and performance and to address their concerns.
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Home Responsibility Environmental sustainability Open and transparent relations Stakeholder engagement
Corporate Responsibility Report 2008 Stakeholder engagement We engage with stakeholders at corporate and local level to inform our plans and approach to managing EHSS and to help identify emerging issues. This includes ad hoc meetings and formalised feedback from our stakeholder panel in the UK (created in 2005) and an EHS stakeholder workshop held in the US for the first time in 2007. In 2008 we expanded the role of the UK panel to provide input to the Sustainability Council. This Council is composed of senior GSK managers and was formed in 2008 to consider the sustainability issues that are important to GSK and recommend actions. This is a component of GSK¶s larger effort to address public concerns about how we conduct our business. We engage with regulators to help them develop controls that protect the environment while safeguarding the development and launch of new medicines. Read more about how we engage with stakeholders and the feedback we receive. See how we fare in benchmarks.
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Home Responsibility Environmental sustainability Open and transparent relations EHSS reporting
Corporate Responsibility Report 2008 EHSS reporting Our primary objective in collecting EHSS performance data is to help our operations manage EHSS issues. This is done through EHS Manager, a web-based information management system. We focus our external reporting on the environmental issues that are most relevant to GSK and of most interest to our stakeholders. Read about our overall approach to corporate responsibility reporting Read about our approach to health and safety and our health and safety performance
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Home Responsibility Environmental sustainability Open and transparent relations Assurance
Corporate Responsibility Report 2008 Assurance SGS Assurance statement
SGS UNITED KINGDOM LTD¶S REPORT ON ENVIRONMENT, HEALTH AND SAFETY DATA IN THE GLAXOSMITHKLINE CORPORATE RESPONSIBILITY REPORT FOR 2008 NATURE AND SCOPE OF THE ASSURANCE SGS United Kingdom Ltd was commissioned by GlaxoSmithKline (GSK) to conduct an independent assurance of the Environmental, Health and Safety data in their Corporate Responsibility (CR) Report for 2008. The scope of the assurance, based on the SGS Sustainability Report Assurance methodology, included 2008 data contained in the following sections of this report: Waste water
Injury & illness rates
Waste
Injury & illness causes
Emissions to air
Fatalities and serious injuries
Climate change
Ergonomics
Energy
Driver safety
Transport impact
Health and safety data table
Water use Environment data table The information in the GSK CR Report and its presentation are the responsibility of the directors and management of GSK. SGS United Kingdom Ltd has not been involved in the preparation of any of the material included in the CR Report. Our responsibility is to express an opinion on the data, graphs and statements within the scope of verification. Financial data drawn directly from independently audited financial accounts has not been checked back to source as part of this assurance process. The SGS Group has developed a set of protocols for the Assurance of Sustainability Reports based on best practice guidance provided in the Global Reporting Initiative Sustainability Reporting Guidelines (2006) and the AA1000 Assurance Standard (2003). These protocols follow differing levels of Assurance depending the reporting history and capabilities of the Reporting Organisation. This report has been assured for content veracity. The assurance comprised a combination of interviews with relevant employees; documentation and record review at nineteen GSK locations during and at the end of the reporting year as follows: Interim site visits during October 2008 in France (Evreux, Notre Dame de Bondeville, Saint-Amand-LesEaux), India (Nabha), Italy (Verona - GMS and R&D), Nigeria (Agbara), UK (Slough, Stevenage R&D, Ware GMS, Worthing) and USA (Clifton, Memphis, Research Triangle Park R&D). End of year site visits during January and February 2009 in India (Nashik, Thane), Ireland (Cork) and UK
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(Irvine, Ulverston and Corporate CSR function in London). The sites selected included those submitting high proportions of key data and included all parts of the GSK business. STATEMENT OF INDEPENDENCE AND COMPETENCE The SGS Group of companies is the world leader in inspection, testing and verification, operating in more than 140 countries and providing services including management systems and service certification; quality, environmental, social and ethical auditing and training; environmental, social and sustainability report assurance. SGS United Kingdom Ltd affirm our independence from GSK, being free from bias and conflicts of interest with the organisation, its subsidiaries and stakeholders. The assurance team was assembled based on their knowledge, experience and qualifications for this assignment, and comprised auditors and assurors registered with IRCA, IEMA and EMAS Verifiers. ASSURANCE OPINION On the basis of the methodology described and the verification work performed, we are satisfied that the Environmental, Health and Safety data contained within the GSK Corporate Responsibility Report 2008 is reliable and provides a fair and balanced representation of GSK¶s Environmental, Health and Safety activities in 2008. We believe that GSK has chosen an appropriate level of assurance for this stage in their reporting. Key areas for improvement to data collection, submission and manipulation were identified during the assurance process and, as far as possible, were addressed to incorporate improvements into this report. These improvement opportunities are outlined below to enable further review to establish the need for system or process changes in future reporting cycles: Some data points which are collated centrally at year end were not fully reviewed to identify anomalies leading to an inconsistent approach in estimating missing data. Several data points have been calculated using new emissions factors and previous years¶ data is restated using the same calculation to allow year-on-year comparison. It is important to ensure that any restated information is fully explained and references to factors used remain current. Some significant contributors to selected data points failed to submit required information. Calculation methodology for ozone depleting substances from patient use of inhalers was updated for one production site but not the remaining sites. It was noted that reported data for previous years may change slightly due to obtaining additional data submissions or updating estimates after publication date. Some anomalies were identified in data submitted when reviewing site level data and comparing 2008 with previous years¶ submissions. Some of these included examples where data had been entered twice following a change to the database. Improvement opportunities identified from site visits were mainly site specific with the most common observations focussing around the following areas: Manual transfer of data and the opportunity for mistakes and variations in roundings in transfer; Utilising the benefits of improvement in regular review and internal checks of data accuracy and formalising secondary review of manual transfers, rather than end of year checks; Extension of monthly reporting rather than quarterly or annual. Improvements identified in previous reporting period have started to be implemented as follows: Specific reports in EHS manager have begun to be implemented, such as the energy module, to reduce the need for additional data transfer from spreadsheets at site level. There may be additional opportunities to extend this to other areas such as waste data provided by key subcontractor. During site visits conducted it was noted that the staff were well prepared and able to provide required
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
evidence to the auditors in the majority of cases, particularly on sites which had undergone previous visits. In addition required changes were generally made promptly where possible. Data from ancillary services or site activities has started to be included, with explanation provided in the comments section of EHS Manager, however site visits identified that there remain some missing items. Review of data submissions indicated an increase in monthly reporting rather then annual or quarterly allowing for more regular review and update of data entries and also indicating discrepancies more clearly. The majority of site visits were conducted in the last quarter of 2008 which enabled issues of concern to be identified and dealt with earlier in the assurance process. Key areas for improvement in data verification process were identified as follows: Sites selected for visits should be identified at the earliest opportunity in order to enable visits to be completed alongside ISO14001/OHSAS18001 certification audits where possible. Recommended that site visits are completed during the last quarter of 2009 to enable any follow-up required to be completed before end of year verification is performed. Recommend selection of key indicators for full review of calculation methodologies across all major contributors, for example VOC and COD emissions and hazardous waste disposal for Primary sites. Recommend site visits include detailed review of source evidence for ozone depleting substances from equipment. Recommend sites selected for visits include: a sample of sites manufacturing inhalers in order to verify data back to source; a sample of sites with significant contributions that failed to submit data; and a sample of sites where significant changes have occurred which were reflected in data submitted. Signed: For and on behalf of SGS United Kingdom Ltd
Pauline Earl Managing Director 25 February 2008 WWW.SGS.COM
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Open and transparent relations GSK response to assurance
Corporate Responsibility Report 2008 GSK response to assurance GSK response to SGS, March 2009 This is the third year that SGS has reviewed the data in the µEnvironment¶ and the injury and illness data in the µPeople¶ section of the Corporate Responsibility report. Verification is complex due to the large amount of data covered and every year the SGS auditors suggest improvements based on their findings. Their unbiased view of our data and processes has been very valuable and we have adopted their suggestions. As a result the quality of our systems and data has continued to improve over the years. SGS selects sites for review based on the magnitude of the contribution of the sites to the overall GSK performance, the types of operations and the degree of difficulty the sites seem to have with reporting. We believe their site evaluations are valuable learning experiences for site personnel. The data included in the corporate responsibility report can be used by the individual sites to monitor and improve their environmental programmes and their health and safety programmes. Therefore, the SGS data verification not only assures the veracity of the data for the corporate responsibility report, it also improves the accuracy and therefore usefulness of data for the sites. We still find challenges in collecting complete and accurate data in a timely fashion. We are committed to continuing to improve this record so that we reach our goal to be able to provide accurate data to the public on the website in real time. Responses to specific key areas for improvement for this year: Selecting sites so they can be reviewed as part of ISO certification Sites have already been selected for the 2009 review so they can be verified in combination with any ISO certifications that take place this year Site visits to be completed during last quarter of 2009 Sites will be notified of their selection for verification visits in the first quarter of 2009 so visits can take place in the last quarter or in conjunction with ISO certification visits earlier in the year Selection of key indicators for full review of calculation methodologies We will work with our sites that manufacture active pharmaceutical ingredients and are the principal contributors to our VOC and COD emissions and hazardous waste to review their calculation methods over the course of 2009 Site visits to include detailed review of source evidence for ozone depleting substances from equipment We will prepare reports of the refrigeration equipment register and SGS will include this in their 2009 site reviews Sites selected for visits to include manufacturers of inhalers, sites that failed to submit data and sites that had significant changes after data were submitted The sites selected for review in 2009 fully represent these groups including some large sales groups that submitted incomplete or late data on injuries and illnesses, and sites from all businesses and regions that made significant data errors We look forward to the improvements that attention to these areas will bring in 2009. James Hagan
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Vice President, Corporate Environment, Health, Safety and Sustainability
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Home Responsibility Environmental sustainability Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders. Your inhaler products have a large environmental impact. What are you doing about this? We have been phasing out CFCs from our inhaler products for the last 15 years, replacing these gases with HFAs which have a lower climate change impact (16 per cent that of CFCs). Less than two per cent of our inhalers now contain CFCs and we have committed to a complete phase-out by 2010. As part of our new climate strategy, we are exploring ways to reduce the amount of HFAs released from our inhaler products and we are looking into alternative propellants. We also offer dry powder inhalers for asthma sufferers which contain no greenhouse gases. These are not suitable for all patients, particularly children and the elderly, as they do not contain propellants and rely on a person¶s lung power for the active ingredients to be administered. How can the pharmaceutical manufacturing process be made more efficient? Making medicines is highly regulated and is complicated due to the number of process steps required. We know that there is more we need to do to improve efficiency and we have set a target to double the average materials efficiency of manufacturing processes for new products introduced between 2006 and 2010. Are pharmaceutical residues present in drinking water and are they a risk to humans? Our studies have shown that GSK pharmaceutical products are either not present in watercourses, or are present at low concentrations. Our risk assessments demonstrate that these concentrations do not pose a risk to human health or the environment. But we are not complacent and we continually monitor the latest scientific studies and findings to improve our risk assessment methodology. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Environmental metrics
Corporate Responsibility Report 2008 Environmental metrics Metric
2001
2005
2006
2007
2008
Energy for operations (million gigajoules)
20.7
19.4
19.3
19.3
19.2
Natural gas
9.87
8.78
9.09
9.04
9.15
Fuels
1.40
1.50
1.08
1.06
0.83
Coal
1.04
0.63
0.47
0.51
0.59
Steam imported
0.28
0.21
0.23
0.22
0.19
Electricity imported
8.10
8.30
8.39
8.45
8.43
Energy for transport 1 (million gigajoules)
5.2
5.2
5.1
Sales force
2.1
1.9
1.7
Air travel
1.6
1.6
1.7
Product logistics
1.4
1.7
1.7
Energy use
Electricity from sustainable sources
0.39
0.14
0.23
0.32
0.26
3,704.5
2,637.2
7,254.3
7,633.5
7,030.8
1,798.5
1,717.5
1,704.0
1,701.7
1,722.3
Natural gas
504.0
448.7
464.5
462.6
467.3
Fuels
86.9
98.7
74.5
72.9
59.7
Coal
93.5
56.8
42.6
45.4
53.2
Steam imported
39.1
16.3
15.8
16.3
12.7
Climate change impact (CO 2 equivalents) 2 Total climate change impact (million kilograms CO 2 equivalent)
CO 2 equivalents from operations energy (million kilograms)
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Electricity imported
1,074.9
1,096.9
1,106.7
1,104.5
1,129.6
CO 2 equivalents from transport (million
123.0
233.0
363.2
363.0
360.8
Sales force
33.0
102.0
145.4
129.0
114.8
Air travel
71.0
112.0
115.8
112.2
123.5
Product logistics
19.0
19.0
102.0
121.7
122.5
CO 2 equivalents from other production
1,783.1
686.7
502.3
369.0
282.2
Inhaler production losses
1,578.8
543.4
398.1
289.1
198.6
Equipment containing greater than 1kg refrigerant 3
116.9
46.8
12.8
13.6
12.8
87.4
96.5
91.4
66.2
70.8
4,685
5,200
4,666
CFC-11 inhalers
242
181
116
CFC-12 inhalers
1,083
1,071
688
HFA-134a inhalers
3,360
3,948
3,861
kilograms)
activities (million kilograms)
CO 2, methane and nitrous oxide from production, waste treatment and other sources CO 2 equivalents from use of inhalers by patients 4 (million kilograms)
Water use and discharge Water (million cubic metres)
26.8
21.8
22.3
20.9
19.7
Municipal
15.20
12.82
12.94
12.23
11.62
Wells or boreholes
11.56
8.59
8.95
9.27
7.78
Other water 5
0.04
0.35
0.37
0.35
0.34
Wastewater volume 6 (million cubic metres)
20.7
16.6
11.7
10.9
10.8
Wastewater to recycling
1.29
1.04
0.73
0.58
0.52
Wastewater to municipal sewer
9.90
8.12
5.67
5.35
5.44
Wastewater to water bodies
9.48
7.46
5.35
5.01
4.83
COD after on-site treatment 6,7 (million kilograms)
27.3
18.7
15.9
14.3
14.9
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COD in recycled water
0.06
0.06
0.01
<.01
0.01
COD to municipal sewer
6.04
4.87
4.08
4.05
3.80
COD to water bodies
21.17
13.81
11.83
10.20
11.08
Hazardous waste generated 8 (million kilograms)
350.7
261.0
241.1
221.8
237.5
Hazardous waste recycled
288.41
193.62
170.73
149.86
183.11
Hazardous waste disposed
62.31
67.36
70.33
71.98
54.36
Hazardous waste incinerated with energy recovery 9
28.69
29.90
30.38
32.72
20.20
Hazardous waste incinerated with no energy recovery
30.25
36.06
39.45
38.68
32.53
Hazardous waste to landfill
3.37
1.40
0.50
0.58
1.64
Non-hazardous waste generated (million kilograms)
132.8
124.0
114.7
120.3
109.4
Non-hazardous waste recycled
79.34
83.82
78.48
83.48
76.55
Non-hazardous waste disposed
53.49
40.20
36.22
36.85
32.87
Non-hazardous waste incinerated with energy recovery 9
5.92
9.94
8.69
8.83
8.35
Non-hazardous waste incinerated with no energy recovery
12.05
6.53
4.93
4.87
4.85
Non-hazardous waste to landfill
35.52
23.73
22.60
23.15
19.67
Non-routine waste generated 10 (million kilograms)
25.3
77.9
28.1
37.7
18.9
Non-routine waste recycled
2.29
39.97
11.10
23.04
11.97
Non-routine waste disposed
22.98
37.96
17.00
14.63
6.90
Non-routine waste incinerated with energy recovery
1.55
7.46
2.55
4.21
0.49
Non-routine waste incinerated with no energy recovery
0.24
0.39
0.79
0.82
1.13
Non-routine waste to landfill
21.19
30.12
13.65
9.60
5.29
Waste generated and disposed
Volatile organic compound emissions
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Volatile organic compound emissions 11 (million kilograms)
6.8
5.2
4.4
4.5
3.9
Acetone
1.24
1.15
1.06
0.96
1.03
Dichloromethane
1.74
0.88
0.85
0.75
0.63
Methanol
0.75
0.71
0.46
0.64
0.54
Ethanol
0.36
0.54
0.46
0.57
0.37
Isopropanol
0.39
0.20
0.28
0.18
0.18
Toluene
0.42
0.06
0.09
0.26
0.06
ODS releases from production (thousand kilograms)
183.5
51.0
32.9
14.9
5.4
CFC-11 releases from production
88.55
14.11
19.35
3.22
1.59
CFC-12 releases from production
94.90
36.86
13.51
11.63
3.82
Ozone depletion potential of refrigerants released from eqauipment (thousand kilograms CFC-11 equivalent)
4.3
3.0
0.7
0.6
0.5
CFC-11 releases from equipment
0.56
1.62
0.42
0.38
0.26
CFC-12 releases from equipment
0.33
0.21
0.02
0.02
0.03
Other ODS from equipment
3.42
1.15
0.22
0.16
0.19
ODS released from patient use of inhalers 13
272.5
182.2
136.5
87.7
CFC-11 from patient use
76.15
50.91
38.14
24.49
CFC-12 from patient use
196.38
131.29
98.35
63.16
23.9
20.5
16.2
Top six solvents released to air (million kilograms)
Ozone depleting substances 12
ODP of refrigerants contined in equipment 14 (thousand kilograms CFC-11 equivalent) Estimated costs and investments Operations and maintenance cost (million )
41.6
39.3
33.9
33.1
31.3
Capital investment (million )
24.4
12.1
9.7
16.8
12.9
Footnotes
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
1. Energy and climate change impact for travel and transport by air, land and sea are calculated using the Greenhouse Gas Protocol starting from distance travelled, not directly from fuel use. In years before 2006 we did not collect all categories of freight transport or employee business travel. Some of the transport data are estimated and we may not capture all routes and employee air travel. 2. Climate change impact is calculated as CO 2 equivalent using the Greenhouse Gas Protocol developed by the World Resources Institute and the World Business Council for Sustainable Development. Each year we review the CO 2 factors and update the data for all years as appropriate. The greatest changes are generally in the updated factors for electricity. 3. In 2008 we reviewed the refrigeration equipment inventories for 2006, 2007 and 2008. Where inventories were incomplete they were estimated based on inventories in other years. We also updated the factors for ozone depletion potential and climate change emissions using WMO (World Meteorological Organisation), Scientific Assessment of Ozone Depletion: 2006, Global Ozone Research and Monitoring Project²Report No. 50, 572 pp., Geneva, Switzerland, 2007. (chapter 8). We calculate the probable releases using a factor from the British Refrigeration Association. 4. We did not have enough information to calculate climate change impact from inhaler use before 2006. 5. Water from other sources includes recycled sources 6. We focus collection of wastewater and chemical oxygen demand data primarily on the major contributors; primary manufacturing operations, pilot plants, coating activities and sterile operations. Some sanitary wastewater streams are included if they cannot be separated from production wastewater streams or if they are significant. 7. Chemical oxygen demand (COD), a measure of water pollution, is measured when wastewater leaves our sites following any onsite treatment. 8. We consider a waste to be hazardous if it has any of the properties defined by the 1989 Basel Convention or if it is radioactive, bioengineered or biohazardous. Basel Convention properties include flammability, explosivity, water or air reactivity, corrosivity, oxidising potential, acute or chronic toxicity, ecotoxicity or infection. Biological waste rendered non-hazardous after treatment is considered non-hazardous waste. We focus collection of hazardous waste on the major contributors; primary manufacturing operations, pilot plants, coating activities and sterile operations. 9. Incineration with energy recovery means burning the material and using the resulting energy. 10. Non-routine waste includes construction and demolition rubble and is not included in hazardous or nonhazardous waste calculations. 11. We focus collection of volatile organic compound emissions on the major contributors; primary manufacturing operations, pilot plants, coating activities and sterile operations. 12. We used WMO (World Meteorological Organisation), Scientific Assessment of Ozone Depletion: 2006, Global Ozone Research and Monitoring Project²Report No. 50, 572 pp., Geneva, Switzerland, 2007. (chapter 8) for ozone depletion potential and climate change emissions factors. 13. Before 2006 we did not have information about inhalers produced in Asia so it was not included in ODP or GWP calculations until 2006. 14. Before 2006 we did not have information about the amounts of refrigerants contained in equipment Back to top
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Home Responsibility Our people
Corporate Responsibility Report 2008 Our people Good employment practices are essential to achieve our business strategy. Our goal is to µbe the best place for the best people to do their best work¶. We employ over 90,000 people in 114 countries across the world. The essential characteristics of a good workplace are integrity, diversity and inclusion, development and creativity. Integrity is critical in everything we do. The GSK spirit defines the culture and behaviours we expect from our employees. Any failures of integrity risk damaging our long-term success. Diversity and inclusion in our workforce demonstrate our commitment to equal opportunities, and enhance our business. Diversity and inclusion help us attract the best people in each of the countries in which we operate, give us a wide range of perspectives to draw on and enhance our understanding of local market needs. Development of our employees means they are more likely to stay with GSK and contribute their best to our success. We encourage our employees to achieve their full potential through training programmes and onthe-job development. We offer a supportive and safe work environment and competitive reward packages. Creativity is fostered in the best work environments. Our aim is that GSK workplaces empower our people to be creative and innovative in their work, for the benefit of the company, shareholders, customers and patients. Employment awards
A selection of the employment awards won by GSK in 2008: UK Ranked fourth in the 2008 Britain¶s Top Employers survey by CRF International and published by Guardian books Best in class in Engineering and Science and shortlisted for best Graduate Employer in Target awards, voted for by graduates and post-graduates Received The Times Employers of Choice for Research and Development Award, based on results of undergraduate interviews Ranked 14th in The Times Top 100 Graduate Employers Survey, a list of organisations that new graduates most want to work for First in the Employee Benefits Award for the most effective use of employee financial education in the workplace, awarded by Employee Benefits magazine Highly commended in PricewaterhouseCoopers Building Public Trust Awards in µPeople reporting¶ category, based on disclosure and strength in human capital management and employee practices US Awarded a perfect score (100 per cent) for Corporate Equality by the Human Rights Campaign Foundation and listed as one of the best places to work for gay, lesbian, bisexual and transgender equality Named one of the 100 best companies by Working Mother magazine, for the 16th consecutive year Awarded platinum honours for workplace and lifestyle programmes, by the National Business Group on
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Health. Identified as a leader in providing a healthy workplace and promoting a healthy lifestyle for employees and their families
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Home Responsibility Our people Our culture and behaviours
Corporate Responsibility Report 2008 Our culture and behaviours Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. We place great emphasis not only on what we achieve, but also on how we deliver our achievements. Integrity is critical in everything that we do. The GSK spirit defines the culture and behaviours we expect from all our employees: Culture Passionate people Patient-focused Performance with integrity Behaviours Innovative thinking Engaging and developing others Leading people Achieving excellence Our mission and spirit help our employees deal with new challenges and maintain a clear focus. We raise awareness of the GSK spirit and help employees to understand and adopt its principles through workshops, team meetings, presentations and awards. We are working to individually empower each of our employees. Empowerment means trusting employees and recognising and rewarding them for achieving their objectives. It helps to encourage innovation and entrepreneurship, and is good for employee morale. Empowered employees take responsibility for their tasks, are able to prioritise better and make decisions more quickly and effectively. Achieving a culture of individual empowerment across GSK will motivate our staff, make us more effective and improve our ability to deal with challenges.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Restructuring
Corporate Responsibility Report 2008 Restructuring In October 2007, we announced a three-year Operational Excellence programme to improve the effectiveness and productivity of our operations. We launched the programme as a response to a more challenging business environment and forecast that it would deliver annual pre-tax savings of up to 700 million by 2010. In February 2009 we announced an expansion to this restructuring programme, to realise increased pre-tax annual savings of 1.7 billion by 2011. In 2009, savings from restructuring will mitigate the decline we expect to our gross margin due to product mix changes with a higher percentage of sales generated from vaccines, Consumer Healthcare and Emerging Markets, and support further investment behind our strategic priorities. The programme includes initiatives to streamline manufacturing, adapt our selling model and improve efficiency in R&D. We are very conscious of the effect this programme will inevitably have on our employees and if options exist where we can achieve our financial goals and preserve jobs we will do everything we can to do so. We consult with employees and their representatives before we implement measures that affect them, such as outsourcing, site closures and staff reductions. We always speak to affected employees first (except where local regulations do not allow it) and then our works councils, trade unions and other employee representatives as appropriate. We aim to treat our employees with dignity and respect and offer a wide range of support for all affected employees. This includes a competitive severance package and outplacement support such as assistance in finding alternative employment, career counselling and retraining. We also work hard to maintain the morale of all other employees at GSK.
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Home Responsibility Our people Consultation
Corporate Responsibility Report 2008 Consultation In Europe our staff or works councils and European Employee Consultation Forum meet regularly, providing an opportunity for employees and company management to discuss key issues and developments in the business. We also recognise trade unions for consultation and collective bargaining in many countries worldwide. Our European Employee Consultation Forum, which includes employee representatives from 28 EU countries, works alongside national consultation processes and is governed by UK law. There is an Operating Sub-Committee of six employee representatives who meet four times a year with six management representatives to receive updates and review proposals affecting the structure of the business. Extraordinary Operating Sub-Committee meetings can be called should the need arise. The whole of the Forum meets once a year at an Annual Meeting to receive a business update from senior GSK executives. In 2008, Eddie Gray, President of GSK Pharmaceuticals Europe, and other business leaders spoke about the opportunities presented by new products in the R&D pipeline, the challenge of growth within Europe and GSK¶s vision for developing the Consumer Healthcare business. We also discuss issues through national consultation forums. For example, the UK Information and Consultation (I&C) Forum which consists of 15 GSK elected employee representatives and seven managers and meets three times a year. In 2008, the I&C Forum reviewed and amended a number of GSK¶s UK policies including those on driving while on company business, further education and special leave. The Forum also continued to review UK-wide redeployment and selection guidelines for redundancy and proposals to handle pension legislation changes taking effect in April 2010. In 2008, the Forum received presentations on strategy from senior managers within Global Manufacturing and Supply and R&D.
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Home Responsibility Our people Communication
Corporate Responsibility Report 2008 Communication Approach
Performance & plans
Good two-way communication with our employees is vital. We aim to keep everyone well informed and involved in company activities, and provide opportunities to get their feedback. Our internal communications channels include: Face-to-face communications, for example through µtown hall¶ style meetings, lunches with the Corporate Executive Team, conferences and team meetings The GSK Experience programme for new starters. This is a mandatory, two-day induction programme that teaches new employees in the UK and US about GSK. Feedback indicates the programme helps them to feel valued and involved. Other countries arrange their own induction programmes locally Spirit, our internal magazine. We print and distribute 33,500 copies throughout the company, four times a year. Spirit is also published on our intranet, myGSK, reaching a broader audience than print alone and allowing our employees to easily give us feedback on articles they have read Our global intranet site, myGSK, provides updates on company and industry news, and a large range of information and resources for employees. myGSK has several features for employees including: myCEO, a dedicated part of the intranet where staff can pose questions to our Chief Executive Officer (CEO) and the other members of the Corporate Executive Team. Employees ask approximately 70 questions each month and our CEO¶s answers are posted regularly on the site The Ambassador intranet community which provides reference materials, information and tools for employees to use as a reference, including presentations, facts and figures An interactive intranet feature, Your Story, which allows our employees to share stories about what inspires them and how this impacts their work with the company An email cascade system where messages are sent to business leaders to share with employees, for example details of our latest financial results Surveys that enable us to monitor employee engagement and help us to track the impact of our internal communications
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Home Responsibility Our people Communication
Corporate Responsibility Report 2008 Communication Approach
Performance & plans
Internal communications Some of the ways that we communicated with our employees in 2008: CEO communications As CEO designate, Andrew Witty held nine employee forums with 250 employees from across the world to help inform his strategic priorities for GSK As CEO, Andrew Witty hosted three global employee broadcasts, recorded live in front of an employee audience. These broadcasts are available for employees to view throughout the year as video on demand via our online video library GSKtv A CEO Advisory Board has also been established which will act as an informal sounding board for ideas. The Board will be filled by employees from across the company Communicating with our senior leaders We held meetings with senior leaders in April and September 2008 to support alignment of the different parts of our business with our new strategic priorities. These were attended by 1000 and 200 leaders respectively. Online communications In 2008 we launched several new features on the company intranet, myGSK, including: A new myCEO discussion forum, called µLet¶s talk¶, designed to support the transition to a new CEO. This received 176 comments from employees between May and December 2008. Employees also sent 456 questions to the myCEO Q&A facility The online version of our employee magazine, Spirit, in September 2008. We also redesigned the magazine and now print it on 100 per cent recycled, chlorine-free paper GSKtv, an online multi-media library which allows employees to view and download a range of videos from across the organisation A new internal website that provides employees with information about what to do in the event of a flu pandemic. Read more about GSK¶s flu pandemic preparedness Business communications Our business units communicate directly with employees through the intranet, µtown hall¶ meetings and other face-to-face meetings, broadcasts and video messages. Many members of the Corporate Executive Team also run live web chats and host Q&A sessions on their intranet communities, ensuring we are aware of areas of concern within regions, business units and functional areas.
Employee surveys Between 2002 and 2006 we conducted Global Leadership Surveys every two years to track management views on a range of issues. The next survey will be run in 2009 and will measure managers¶ perceptions of our progress towards achieving our new strategic priorities which were introduced in 2008.
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Our plans We are continually reviewing the effectiveness of our communications and how we can improve them. Employees are encouraged to ask questions and comment on the information we provide and the communication channels we use. As technology is updated, it is easier for us to encourage direct communication and discussion with employees. In 2009 we will expand our use of technology, such as social media tools, to encourage greater collaboration and communication across GSK, breaking down traditional communication barriers.
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Home Responsibility Our people Diversity and inclusion
Corporate Responsibility Report 2008 Diversity and inclusion Approach
Performance & plans
At GSK, we recognise the value that different perspectives and experiences bring to GSK and we aim to recruit a diverse range of employees to our global workforce. We respect all our employees and include talented people in the workforce regardless of race, gender, sexuality, age, religion and belief or disability. We do not require medical testing as a prerequisite for employment. We aim to adopt inclusive work practices that create an environment where employees feel individually and collectively empowered, and can develop and contribute to the business to their full potential. Being a diverse and inclusive business helps GSK to recruit and retain the best people for the job. It also enables us to understand and meet the needs of diverse patients, customers and consumers.
Global diversity policy Our commitment is set out in our global diversity policy. Our Corporate Executive Team endorses the policy and related activities such as our annual Multicultural Marketing and Diversity Awards. All our employees are expected to comply with this policy. Allegations of discrimination are taken extremely seriously, fully investigated and findings acted upon. Each business has diversity champions, employees that promote diversity issues. In the UK and US we have Diversity & Inclusion (D&I) steering committees, made up of human resources managers and line managers with specific responsibility for diversity and inclusion. The committees run diversity awareness campaigns and training sessions. GSK also monitors and reports on gender diversity in management in the UK and US.
Employee networks Employee networks are an important element of our diversity and inclusion programme. They support professional growth and provide a forum where people with similar interests or backgrounds can meet, discuss shared experiences and address any problem areas. This helps engage and empower employees. The networks are an important source of expertise on diversity issues. GSK managers can engage with the networks to improve their understanding of employees from different backgrounds. Networks also help our media and marketing teams understand our diverse customers and stakeholders. GSK has networks for Asian, African American, Hispanic, gay, lesbian, bisexual and transgender employees. We also have networks for mature employees, employees early in their career, women in leadership and veterans. Each network has an executive sponsor who helps to set and achieve goals, obtain resources and promote the network¶s objectives among senior management.
Disability We work to ensure people with disabilities can access the full range of recruitment and career opportunities at GSK. In the UK, we partner with the Employers¶ Forum on Disability and strive to be a µdisability confident¶ organisation. Disability confidence is a concept developed by the Employers¶ Forum to describe companies that create a culture of inclusion, remove barriers to access and make adjustments to enable individuals with disabilities to contribute as employees, customers and partners. We hold the µTwo Ticks¶ symbol from
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JobCentrePlus, which demonstrates GSK¶s commitment to employing disabled people. Read more information on our approach to diversity and inclusion. Positively managing HIV in the workplace
We do not discriminate against prospective and current employees based on HIV status and do not require testing as a prerequisite for employment. We maintain medical confidentiality at all times. We provide information and training to staff on HIV/AIDS prevention and addressing problems of stigma relating to the disease. We provide HIV/AIDS testing, voluntary counselling and treatment programmes to employees and their families in countries where these are not easily available via government healthcare programmes. We also offer preferentially priced anti-retrovirals or equivalent not-for-profit arrangements to other employers in Sub-Sahara Africa who have their own workplace clinics
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Diversity and inclusion
Corporate Responsibility Report 2008 Diversity and inclusion Approach
Performance & plans
Gender diversity We are pleased that the percentage of women in management has increased incrementally in the last five years. However, there is still a lot of room for improvement. Gender diversity in management 2008 Per cent positions held by women (worldwide)
2004
2005
2006
2007
2008
Corporate Executive Team, senior vice presidents, vice presidents
19
21
22
22
25
Director grade
33
33
34
35
36
Manager grade
38
38
39
40
41
All management positions
35
35
36
37
38
Gender equality in the workplace is affected by many factors, some external to GSK, including the requirements of family life. Our flexible working policies help employees balance the demands of work and home life. They can be particularly beneficial for caring and family responsibilities. For example, we offer part-time working, job sharing and remote working. Read more about our programmes encouraging women in science: Women in Science Events and the Scientific Women¶s Scholarship Programme.
Ethnic diversity In the US, minorities (defined as Blacks, Hispanics, Asians, Pacific Islanders, American Indians and Alaskan natives) made up 20.5 per cent of our workforce in 2008, compared with 20.1 per cent in 2007, 19.8 per cent in 2006 and 19.6 per cent in 2005. In the UK, ethnic minorities accounted for 19.2 per cent of employees, in 2008 compared with 19.1 per cent in 2007, 18.3 per cent in 2006 and 16.8 per cent in 2005. Ethnic minorities accounted for 12.5 per cent of the UK population of England and Wales in 2001, the last UK Census. We use the UK Commission for Racial Equality definition of ethnic minorities. This includes anyone who does not identify themselves as White British, so this means people identified as White Irish, North American and European are included as minorities. We also measure diversity in the UK by counting the number of employees that define themselves as nonwhite. In 2008, 12.1 per cent of employees defined themselves as non-white, compared with 11.8 per cent in 2007, 11.6 per cent in 2006 and 11.0 per cent in 2005. Ethnic minorities (US)
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Ethnic minorities (UK)
Multicultural marketing and diversity awards Our annual Multicultural Marketing and Diversity Awards aim to inspire employees to find creative ways to reach a broader range of potential employees, customers and communities. Awards are given in categories such as employee attraction, development or retention; multicultural marketing and sales; community outreach; and diversity ambassador. The 2008 Awards recognised 13 project teams and five individuals. Award-winning projects included: An initiative that, over four years, increased the representation of diverse subjects in US clinical trials from just under 20 per cent to 35 per cent, slightly higher than the overall US minority population A literacy programme to teach 154 Indian manufacturing employees how to sign their names on official documents instead of using a thumb print Read more in our case study on this literacy programme.
Our plans During 2009 we plan to simplify our approach to diversity and inclusion, ensuring that this maximises employee empowerment.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Training and development
Corporate Responsibility Report 2008 Training and development Approach
Performance & plans
Training and development opportunities help employees feel valued and engaged in their work. GSK provides work-related training courses for all employees, and leadership training for managers. These focus on providing people with the right behaviours and expertise for their jobs and the skills needed to apply their knowledge effectively. Our goal is for each individual to achieve their potential and contribute fully to company performance. We conduct regular appraisals to identify training needs and help employees set and achieve development objectives. We operate 360- degree assessments for our top managers to ensure they receive objective feedback on their performance from the employees they manage and colleagues that they work with, as well as their manager. Training is carried out within each business function and online, for example through our µmyLearning¶ intranet site in the US and UK. We also offer project secondments to help employees learn new skills.
Leadership development We identify high-performing employees and potential leaders in each business function through our annual talent management cycle. Managers are accountable for developing talent and successors and this is a top priority for every leader. The process ensures we have the diverse and high-performing talent required to deliver our business strategy and to reflect the global growth of GSK. Talented people participate in leadership programmes and connect with senior management through programmes such as the Chief Executive Forum. Our leadership framework helps employees fulfil their potential, become leaders in their field and contribute fully to our business performance. Specifically, it helps them to: Develop the behaviours that distinguish high-performing leaders. These include innovative thinking, engaging and developing others, leading people and achieving excellence in their work Understand their behaviour, take personal responsibility for their actions and continue to perform with integrity Enhance their expertise, including technical and functional skills and broader knowledge. These contribute directly to GSK¶s overall performance and are likely to be unique to the position, role or function of each employee Effectively use and apply the processes and practices within GSK We also provide extensive health, safety and environment training for our employees.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Training and development
Corporate Responsibility Report 2008 Training and development Approach
Performance & plans
The majority of our employees receive an annual performance appraisal through our Performance and Development Planning (PDP) programme. Compliance with this requirement is measured at local level, but we know that more than two-thirds of employees received an appraisal in 2008. The PDP programme assesses how well employees have implemented GSK business principles through their work. The appraisals impact on bonus payments and future career development. In 2008, we focused on embedding our leadership framework. This included the following training initiatives: µHot Topics¶ training which focused on how to lead in times of transformational change. Nearly 1,700 managers and senior leaders attended Workshops to teach GSK leaders about the importance of coaching their staff and techniques for doing so effectively; 138 managers took part in the workshops in 2008 Online development resources available for all English-speaking employees, providing a variety of steps they can take to build leadership skills We also offered over 3,000 learning programmes to all GSK employees via our online learning management system.
Our plans During 2009 our Leadership and Organisation Development function will work to support GSK¶s strategic priorities. Plans include forecasting and delivering the capabilities needed for the future growth and success of GSK. In addition, leadership development will continue as an area of focus, including refining the behaviours necessary for successful leadership and supporting this with prescribed learning and development opportunities and experiences.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Reward and recognition
Corporate Responsibility Report 2008 Reward and recognition We offer employees a competitive salary based on industry benchmarks, as well as performance-related incentives and other benefits. This helps us to attract and retain the best people. We particularly reward employees for innovation and good performance and we reward leaders who empower their staff. Our pay strategy for managers is based on a programme called TotalReward that helps us recognise good performance and enables managers to share in GSK¶s success. We use feedback from managers to identify the types of reward that they prefer. Components of TotalReward include: Cash, including salary, bonuses and incentives (including long-term incentives for eligible employees), and recognition awards. Salaries are allocated within defined bands for different employment levels Savings choices such as pension provision and share schemes Lifestyle benefits, for example healthcare, childcare support and employee car ownership programmes TotalReward applies to GSK managers around the world, although the component parts of an employee¶s package will differ by country in accordance with local legislation and best practice.
Share ownership Our share ownership schemes help to create a culture of ownership among our employees. In countries where share ownership opportunities exist, they are open to all employees and there is a high level of participation. For example, in the UK 67 per cent of employees participate in our ShareSave scheme, and 85 per cent in our ShareReward scheme.
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Home Responsibility Our people Health, safety and wellbeing
Corporate Responsibility Report 2008 Health, safety and wellbeing Keeping our employees and contractors healthy and safe is a priority. Our rigorous management system reduces the risk of harm to our employees and helps them stay healthy. It is part of our broader environment, health, safety and sustainability (EHSS) programme. As well as being the right thing to do, this improves business performance by increasing attendance, improving productivity and reducing healthcare and insurance costs.
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Home Responsibility Our people Health safety and wellbeing Health and safety management
Corporate Responsibility Report 2008 Health and safety management We manage health and safety through an integrated environment, health, safety and sustainability (EHSS) management system. This incorporates our EHS and sustainability vision and policy and associated standards. Our EHSS Plan for Excellence includes our strategy for improving EHSS performance up to 2015. We employ health and safety professionals across sites within business units and at the global level to manage health and safety risks across GSK. Read more about our EHSS management system. Our occupational health and safety data is independently assured. Assurance does not include personal health and wellbeing programmes and data.
Audits and performance As part of our overall environment, health, safety and sustainability audit programme, we conduct occupational health and safety audits at our sites every one to four years. The frequency depends on current risks and past performance. We carry out more frequent visits at some sites, based on the degree of risk at the site, its health and safety performance and the issues raised by previous audits. Audit results are presented to the Audit Committee of the Board of Directors. Our occupational health and safety target [link to environmental sustainability/plan for excellence/targets] is to reduce reportable injuries and illnesses by five per cent a year from 2006 to 2010, and to be placed within the top quartile of comparable industry ratings by 2012. We systematically assess and manage occupational health and safety risks and performance. When incidents do happen we identify root causes and take action to prevent reoccurrence. We believe that addressing the causes of incidents will help eliminate risks and hazards, and prevent future occupational injuries and illnesses. In 2008 we audited 31 GSK sites for implementation of occupational health and safety standards as part of our overall environment, health, safety and sustainability audits. The average audit score was 78 per cent which compares to our 2010 target of 82 per cent. Best performance was seen in fire prevention, site management commitment to occupational health and safety, investigation and reporting or injuries and illnesses and emergency planning and response. Sites were generally weakest in resilience and mental wellbeing, control of chemical agents, use of work equipment, risk assessment, permit to work systems, noise control and ergonomics. Auditors found two µcritical findings¶, which indicate a high probability of incidents with potentially serious consequences. The first related to deficiencies in controlling the risk of falls during a construction project and the second was related to the risk of fire from inadequate management of highly flammable liquids. These issues are monitored to ensure that appropriate actions have been taken to mitigate risks and ensure ongoing compliance. In 2008 one of our active pharmaceutical ingredients manufacturing sites was fined 50,000 by the UK regulator, HSE, for a process safety incident that occurred in 2006. A serious explosion occurred at the Irvine, UK site, involving a µplacebo¶ batch used to test plant conditions and controls. Two operators were injured. The event has been thoroughly investigated, learnings shared and improvements made. This was reported in our 2006 Corporate Responsibility report.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
In 2008, a site in the US received a fine of $1,375 from the South Carolina state Occupational Safety and Health Administration (OSHA) for violations of forklift regulations. These concerns have been addressed at the site.
OHSAS 18001 certification Twenty-six of our 78 Pharmaceuticals and Consumer Healthcare manufacturing sites and one Consumer Healthcare R&D site are certified to the international health and safety standard OHSAS 18001. We have set a goal for all manufacturing sites to be jointly certified to OHSAS 18001 and the environmental standard ISO 14001 by the end of 2010. In 2008, three new sites were certified. The certified sites are in Argentina, Australia, Brazil, China, Egypt, France, Germany, India, Japan, Kenya, Mexico, Panama, Philippines, Poland, Saudi Arabia, Spain, Turkey, the US and the UK.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Health safety and wellbeing Hazard assessment and communication
Corporate Responsibility Report 2008 Hazard assessment and communication Assessment Understanding the intrinsic hazards of the materials we produce or use in research, development and manufacturing is an important first step to enable us to effectively manage health and safety risks and prevent damage to the environment. Our occupational toxicologists and environmental scientists assess materials hazards throughout product development. Increasingly, we use computer-based modelling and in vitro methods instead of animal tests. We use hazard information to assign occupational and environmental exposure limits that help guide the design of systems used to protect our employees¶ health and to protect the environment from chemical contamination. Our hazard assessments help us meet regulatory requirements such as the new EU Registration, Evaluation and Authorisation of Chemicals (REACH) legislation.
Communication We provide hazard information to enable our employees, contract manufacturing partners and customers to handle and dispose of our materials and products safely. We develop safety data sheets for new materials and products as they progress through the development process. This ensures that health and safety information is readily available to our staff before they handle chemicals and to our customers when the product is launched. We distribute safety data sheets using a web-based system. It provides safety information for nearly 4,500 GSK materials and key manufacturing and process chemicals. It also includes over 2,200 safety data sheets for pharmaceutical, biological and consumer healthcare products. The information is regularly updated and is available in English, French, German, Italian, Portuguese and Spanish. Safety data sheets for our products are available on our website and are also communicated directly to our customers via fax on demand, or through customer response centres.
Safe transport of materials As part of our normal business operations we transport materials that require special handling such as chemicals, biological and radioactive materials, and finished products. We have a network of highly trained employees to oversee transportation-related activities to ensure materials are transported in a safe and effective manner that complies with national and international laws and conventions. This ensures that our employees, the public and the environment are kept safe. We use two systems that support tracking, classification and emergency information for the transportation of chemical, biological and radioactive materials. The HazClass system is available for use by R&D sites. Manufacturing sites use the SAP system to manage transport of their materials and products.
Understanding fire and explosion risks Our in-house fire and explosion laboratory conducts tests to determine fire and explosion properties of materials handled in research and development and manufacturing. This work is primarily driven by the requirements of the EU regulations on explosive atmospheres (Directive 99/92/EC, ATEX 137). When manufacturing sites receive hazard data from laboratories, they undertake risk assessments to design work practices that eliminate or reduce the risk of fires and dust explosions.
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Home Responsibility Our people Health safety and wellbeing Safety programmes
Corporate Responsibility Report 2008 Safety programmes We operate a number of programmes to keep our employees and contractors safe:
Chemical exposure We have rigorous procedures and controls in place to ensure employees involved in developing and manufacturing our products are protected from exposure to chemicals. We have a goal to make 80 per cent of operations involving the handling of hazardous compounds µrespirator free¶ by 2010. This means employees will not need to wear respiratory protective equipment for routine production tasks. Instead, sites will install technology that prevents the release of hazardous compounds into the work environment. For example, we have installed contained powder transfer systems and glove-box technology at our pilot plant facility in Cork, Ireland, and a special containment system at our new penicillin facility in Pakistan. We have also developed a proprietary manufacturing technology which greatly reduces operator exposure to medicines as they are manufactured. Each GSK site monitors air quality to assess exposure to hazardous compounds and implements controls to protect employees and achieve our µrespirator free¶ goal. Our occupational hygienists, employee health staff and engineers work together at site, regional and global levels to reduce employees¶ exposure to chemicals. By the end of 2008 over 40 per cent of operations had achieved a µrespirator free¶ level of engineering control based on at least some occupational hygiene monitoring results. We continue to upgrade engineering controls to achieve µrespirator free¶ levels of control. For situations where engineering controls are not possible, employees will remain protected by appropriate respiratory and other protective equipment.
Process safety Many of our products begin with the formulation and processing of hazardous materials such as flammable solvents and combustible powders. Our scientists look for opportunities to eliminate the use of these hazardous materials through our green chemistry and green technology programmes. Where substitution or elimination is not an option, our process safety programme aims to ensure that safety is built into manufacturing, research and development processes, and that employees receive training to understand risks and implement appropriate controls. Our engineers use an online assessment system to develop safer processes and plant maintenance strategies and to share hazard information and control strategies across GSK. We have reviewed and updated our process safety strategy after two employees were injured in an explosion at our factory in Irvine, UK, in 2006. Using the results of this review, we are continuing to update and integrate our process safety management system (PSMS) into our EHSS management systems at all GSK sites. This includes: A design code containing new engineering standards for process safety Assessments against the new engineering standards, with gap analyses Upgraded risk assessments and remediation processes Process safety indicators Steps to embed process safety in the overall safety culture
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
New training and competence programmes and process safety tools We also appointed a new director of process safety.
Safety engineering Our safety engineering programme focuses on improving construction and plant safety and ensuring effective emergency response systems. We have developed safety engineering guides to managing the risk of fire and explosion and to provide guidance on machine guarding and electrical hazards. These web-based guides provide a standardised approach to managing safety risks across GSK. We also ensure that safety is built into and maintained at our sites worldwide through the following programmes: Risk Assessment and Control Processes, Construction Contractor Safety Programme, Capital Project EHS Review Process and our Emergency Response Programmes.
Ergonomics Musculoskeletal illnesses and repetitive strain injuries are some of the leading causes of time away from work. Our Corporate Executive Team has set a target to reduce the number of these illnesses and injuries by five per cent each year through to 2010. Good workplace and job design, known as ergonomics, helps employees to do their jobs effectively while reducing the risk of musculoskeletal illnesses and injuries. There are 70 ergonomic improvement teams working across GSK businesses to assess and manage the ergonomic risks of existing operations and planned projects. Teams include members from areas such as manufacturing quality, safety, health and medical services and those that perform the work itself. Teams work together to identify risks, develop solutions and share best practice globally through a dedicated ergonomics community on our intranet. In addition, over 900 trained facilitators throughout the business help to manage computer-based ergonomic risk assessments for over 30,000 employees. These assessments identify steps to reduce discomfort and injury relating to computer use. Information about ergonomics best practice is also available to employees on our intranet site. These efforts have contributed to: A 4.7 per cent improvement from 2006 to 2008 in ergonomics-related injury and illness. This is short of our target of an annual five percent improvement through to 2010, equivalent to a 10 per cent improvement over 2006 to 2008. In order to meet or exceed our target in 2009, we will increase our effort and resources in this area Cost and productivity gains in manufacturing operations. For example, in 2008 at our Nabha site in India, a manual handling task was improved resulting in simplified work process, reduced risk of injury and reduction in the number of employees needed to perform the task from three people to one person. This allowed the two workers to focus on other tasks while reducing the risk of injury for all workers Improved audit scores through implementation of ergonomic improvement processes. For example, Kuala Lumpur improved its µergonomics management of risks¶ score from 43 per cent to 80 per cent as a result of implementing an ergonomics improvement process, and improved its overall audit score Significant impacts on introduction of new ergonomics improvement teams. For example at our Tianjin facility in China, six major ergonomic improvements initiated by the new team in their first months resulted in a 40 per cent reduction in reports of discomfort/injury and improved morale The GSK ergonomic improvement teams were given special recognition in 2008 by the European Safety and Health Council as part of a Europe wide-focus on improving manual handling Internal recognition of the global ergonomic community team and process as an example of new ways of working at GSK with shared global resources spanning functions, businesses and cultures. The team won an award in our 2008 µCross sector multicultural marketing and diversity awards¶
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Driver safety Our sales representatives spend significant amounts of time driving and are therefore at risk of being involved in road traffic incidents. We aim to reduce this risk as much as possible through our worldwide driver safety programme. This includes instructions and guidelines on driver training, vehicle selection, risk assessment and accident reporting. We have a motorbike rider safety manual for employees in countries where we provide motorbikes or scooters. Around three-quarters of GSK¶s commercial businesses have extensive driver safety programmes in place, including driving licence checks, guidance on the use of mobile phones, safety training and tracking and reporting incidents. We plan to extend these to our other sites. The most common cause of fatalities and serious injuries remains driving accidents. In 2008, 15.9 per cent of the injuries with lost time were due to motor vehicle accidents, as were 19.7 per cent of the injuries without lost time. In 2008, two road traffic accidents caused the death of two of our employees. See µFatalities and serious injuries¶. Defibrillator programme
In 2007 and 2008 six people were resuscitated using automated external defibrillators (AEDs). An AED is a safe and easy to use portable medical device that analyses heart rhythm and delivers electric shocks to victims of ventricular fibrillation in order to restore the victim¶s heart rhythm to normal. We began expanding the number of sites with AEDs when they were used in saving several lives in the US and UK in 2005 and 2006. Key personnel are trained to use AEDs in emergency situations and the equipment is installed at an estimated 100 GSK sites in Belgium, Brazil, Canada, Egypt, France, Germany, India, Italy, Japan, Mexico, Puerto Rico, Singapore, South Africa, Spain and US. We used a risk assessment to decide which sites should have AEDs, based on factors including heart disease risks among employees, hazards on site such as chemicals or energised circuits that could cause cardiac arrest, and ambulance response times.
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Home Responsibility Our people Health safety and wellbeing Health and wellbeing programmes
Corporate Responsibility Report 2008 Health and wellbeing programmes GSK offers programmes to boost employee health and wellbeing and to create and sustain energy and engagement with their work. This in turn helps improve our business performance. GSK helps improve employee wellbeing by offering flexible working options and health and wellbeing initiatives. These include health risk appraisals, screening for diabetes and hypertension, smoking control support, fitness and nutritional advice, and immunisations. Our prevention and screening initiatives focus on the leading causes of illness and disability among our employees which include depression, non-workrelated injuries, heart disease, stroke and respiratory infections. Increasingly we are also focusing on ways to encourage team and personal energy and resilience in times of high pressure. Many of our employee health and wellbeing programmes have won national awards for excellence in 2008, such as the Platinum Awards from the National Business Group on Health (NBGH) in the US and the Health Promotion Board in Singapore for our team resilience programme. We received an award in 2008 from the NBGH for innovation and commitment to providing lifestyle improvement programmes designed to improve healthier lifestyles for our employees.
Energy and resilience We define resilience to describe the skills and traits necessary for success in a high-pressure working environment. These skills and behaviours also help prevent mental illness due to stress, a leading cause of ill health and disability at work. Energy for Performance When employees have energy they can focus better and perform their tasks more efficiently. The Energy for Performance (E4P) programme is designed to boost energy levels and help employees invest energy in the right way, at work and at home. Uptake was good: 1,626 employees participated in E4P workshops in 2008. Over 3,000 employees from over 30 countries had attended E4P workshops by the end of 2008. Over 80 per cent have reported significant improvement in their physical and mental performance and emotional energy. Participants found that their performance improvements persisted for at least 12 months after the workshop. Personal resilience We run workshops for employees who want to enhance and build their personal resilience. Focusing on improving work and home life, the programme aims to help employees increase their focus, energy and confidence while also helping to reduce tension, anxiety and fatigue. Since the programme started in 2007 over 1,100 employees have participated in the programme Team resilience Healthy, collaborative and motivated teams are critical to business success. The Team Resilience programme helps employees and their managers to identify sources of pressure on their teams, such as process complexity or lack of workplace flexibility or accountability. Teams then work together to agree action plans to address their concerns. The programme helps teams take more control of their work, and eliminate or manage the sources of pressure that can lead to ill health or
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inefficiency. Since the programme began in 2003 it has been completed by teams in 51 countries, comprising 26,500 employees by the end of 2008. Participants report an 80 per cent reduction in workplace pressures, 25 per cent drop in work-life conflict and a 21 per cent increase in satisfaction with GSK as an employer.
Wellbeing and work-life balance GSK offers programmes to improve the health of employees and their families. We find this increases employee commitment and productivity and reduces absenteeism and the cost of ill health. Support varies between countries and according to local needs. Our sites use public health and GSK data to identify high risk areas and investments that lead to significant health and cost improvements. Programmes often include benefits such as on-site health and fitness centres, flexible working arrangements, immunisations, regular medical check-ups, assistance to stop smoking, disease screening and management, family support services and health education. We also assist employees suffering from chronic diseases to ensure they have access to the correct long-term treatment and support. Our programmes help local healthcare services by focusing on health education, prevention awareness and management of current conditions. We have created a network of GSK employee health professionals to share health and wellbeing best practice. GSK also supports key public health efforts such as World AIDS Day, the World Health Organization¶s Health Day, Tobacco Free Day and Global Handwashing Day.
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Home Responsibility Our people Health safety and wellbeing Health and business continuity
Corporate Responsibility Report 2008 Health and business continuity We have developed contingency plans to protect our employees and business in the event of natural disasters, man-made emergencies or a flu pandemic. These plans aim to ensure that our business can continue to function and we can continue to supply critical medicines to patients. We have also developed and implemented programmes to protect more than 435,000 staff, their dependants and key complementary workers in over 130 countries in the event of a pandemic. We offer employees annual seasonal flu vaccination in 95 per cent of our markets, as well as travel health programmes. We stockpile multiple antiviral medicines that can be used to prevent or treat pandemic flu. From 2009 this will include pre-pandemic vaccines, which can be administered before a pandemic has started, and a pandemic flu vaccine which will be available six months after the exact pandemic flu strain has been identified. In the event of an outbreak we will implement special rules to prevent the disease spreading among our workforce. For example, non-essential services will close, face-to-face meetings will not be held and special cleaning and personal protective programmes will be implemented. We will restrict business travel and access to GSK sites and employees will be encouraged to work from home. We have developed a special website, accessible on our intranet and externally, that acts as a single source for all global and local flu information across GSK.
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Home Responsibility Our people Health safety and wellbeing Training and awareness
Corporate Responsibility Report 2008 Training and awareness Training helps to create a workplace culture where occupational health and safety is taken seriously. Employees who are responsible for managing occupational health and safety issues at sites and business units receive regular training and in turn instruct employees about safe working. We give training on our environment, health, safety and sustainability (EHSS) standards, as well as programmes such as process safety, chemical exposure protection, identifying risk, auditing and ergonomics. Sites develop and conduct training based on local needs and capabilities. Some use our internal learning tools, commercially available training programmes or locally available government or university sponsored training programmes. We have developed a training framework that identifies gaps in employees¶ knowledge of health and safety and provides in-house and external training courses. Our health and safety professionals share knowledge and best practice via teleconferences, intranet communities, training programmes and discussion forums. We raise awareness about employee health and safety issues through: Employee bulletins Announcements on our myEHS Community intranet sites The CEO¶s EHS Excellence awards programme Health and Safety Week, held in October to coincide with the European Health and Safety week. The event encourages employees to address potential risks at work and at home. Over 13,000 employees from 76 sites in 26 countries took part in the 2008 Health and Safety week activities. Read more about training on environment, health and safety issues. Health and safety: Worthing EHS challenge competition
In 2008, GSK¶s penicillin manufacturing facility in Worthing, UK, ran four competitions to improve employees¶ knowledge of EHS issues. Each month, the EHS team sent five questions to all staff on topics such as fire and evacuation, first aid, how to respond to penicillin exposure and the site¶s EHS targets. The following month, the questions were posed to five employees from each work unit and points were awarded for correct responses. The team published a league table each month and every quarter the winning team was awarded 1,000 for the charity of their choice. In total, competition winners gave 4,000 to charity in 2008. Following its success at Worthing, the competition was introduced at 12 more sites in the UK, France, China and India in 2008. This project won second place in the 2008 CEO¶s EHS excellence awards in the Safety Initiative category.
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Home Responsibility Our people Health, safety and wellbeing Performance
Corporate Responsibility Report 2008 Performance Performance
Data table
Injury and illness rates Our main health and safety measure is the reportable injury and illness rate. We also measure the number of injuries and illnesses that result in lost days, as well as the number of days lost from these injuries and illnesses. This provides an indication of the severity of the incidents, although it is only a rough guide. We have set targets to improve injury and illness rates. Injury and illness targets Injury and illness target
Progress 2006 to 2008
To reduce the reportable injury and illness rate by 5 per cent each year to the end of 2010
Improved 16 per cent
To reduce the reportable musculoskeletal illness and injury rate by 5 per cent each year to the end of 2010
Improved 4.7 per cent
To rank in the first quartile of an industry benchmark group
Improved ranking by one place, remaining in third quartile
Data cover GSK employees and contract workers who we directly supervise. We report separately data for contractors who work on GSK sites but supervise their own staff in the data table . Contractors¶ data are not externally verified. Injury and illness data are collected from all 79 of our Pharmaceutical, Consumer Healthcare and Nutritionals manufacturing sites, 14 of our 15 vaccines sites (one site is not yet in operation), 29 of 31 Pharmaceutical and Consumer Healthcare research and development sites (two sites are considered too new to start reporting), the US and UK headquarters sites, eighteen offices and sales groups with more than one million hours worked, and 46 of the smaller offices and distribution centres. In 2008 some sales and office sites did not report injury and illness data. We estimate that approximately three per cent of the data are missing due to one large sales group that reported injury and illness in 2007 but not in 2008. Injury and illness rates
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The reportable injury and illness rate continues to improve at an average rate of more than five per cent per year across GSK. In 2008 there were 847 injuries and 284 illnesses, a total reportable injury and illness rate of 0.6 reportable injuries and illnesses per 100,000 hours worked. This was an improvement of 16 per cent from the 2006 baseline, exceeding our target. The reportable ergonomics-related injury and illness rate has improved 4.7 percent from 2006-2008. This is short of our target of an annual five percent improvement through to 2010, equivalent to a 10 per cent improvement over 2006 to 2008. In order to meet or exceed our target in 2009, we will increase our effort and resources in this area. In our Pharmaceutical and Consumer Healthcare manufacturing organisation, where injury and illness rates are included in managers¶ objectives, the rate has improved 27 per cent from 2006 to 2008. Machinery safety projects at many manufacturing sites, and projects encouraging employee safety awareness, are examples of initiatives contributing to this improvement. The rate of lost-time injuries and illnesses has improved only 3.3 per cent from 2006 through 2008 to 0.33 lost-time injuries and illnesses per 100,000 hours worked. However, days lost per 100,000 hours has improved 11.3 per cent indicating a lower number of days lost per incident, possibly an indicator of less severe injuries and illnesses. In 2006 and 2007 our injury and illness performance places us in the third quartile of a benchmark industry group, which means we need to improve. Our target is to be in the top quartile of comparable industry ratings by 2012. Read a case study on how a site has improved safety during shutdown.
SGS verified
Injury and illness causes The most frequent types of incident overall are ergonomic, mainly musculoskeletal illnesses and repetitive strain injuries, accounting for 27.7 per cent of all injuries and illnesses. We continue to expand our ergonomics programmes to address this cause of injury and illness The most frequent reportable injuries are slips, trips and falls, and account for 19.3 per cent of all injuries and illnesses in 2008. A team is being assigned to look into ways to address this type of injury Injuries due to machinery accounted for 17.5 per cent of all injuries and illnesses. Our manufacturing sites are renewing their focus on machine safety to continue improvements in this area. Road traffic accidents accounted for 13.0 per cent of all injuries and illnesses in 2008 and two fatalities detailed below.Driver safety is a continuing area of focus especially in the sales force.
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Mental ill health accounts for 3.8 per cent of all injuries and illnesses but these cases result in the highest number of days lost at over 76 days per case on average or 21.5 per cent of the total number of days lost for all injuries and illnesses. This is being addressed by our resilience programme.
SGS verified
Fatalities and serious injuries Employee fatalities Five year trend in employee fatalities 2008
2
2007
2
2006
3
2005
1
2004
2
2003
5
2002
3
In 2008, one of our sales employees was killed in a fatal road traffic accident in the Philippines. Three passengers were also killed in the accident. One of our sales employees in India was killed in 2008 when he fell from his bicycle into the path of an oncoming motorized three-wheeler when the front tire of his bicycle was punctured. Two GSK employees were seriously injured in another road traffic accident in India in 2008 when the vehicle in which they were being transported by a contract driver struck another vehicle, killing two people. In 2008, there were five amputations and a serious finger injury due to accidents with moving machinery. Three employees had amputations of fingers or finger tips, one employee sustained amputation of a foot and one contract worker had an amputation of his forearm. An employee in the US was injured when his foot was caught between powered rollers. Reconstructive surgery proved unsuccessful and the foot had to be amputated A contract worker in India reached into a clothes dryer while it was rotating to remove an article of clothing, resulting in amputation of his forearm An employee in South Africa slipped on a wet floor and grabbed a piece of equipment to keep from falling. His weight caused a valve to close on his hand amputating his finger at the top joint and badly crushing two fingers. The severed finger was re-attached, but the crushed fingers could not be saved and were amputated An engineering mechanic in Pakistan placed his hand on an operating piece of machinery. A tube holder struck a finger inflicting severe damage resulting in amputation An employee in the US was clearing a jam on an assembly/packing machine and placed her hand on a part of the machine that closed on her finger amputating the finger tip A fitter in Australia suffered serious lacerations to his finger while installing a cutter on a blister pack machine. Hospital treatment was required but amputation was avoided All of these amputations resulted in renewed emphasis on machine guarding programmes at these sites.
SGS verified
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Injury and illness milestones All GSK operations strive to work without experiencing any lost-time injuries or illnesses. We issue certificates signed by business heads to sites that reach one million hours worked without a lost-time injury or illness. Sites that reach two or more million hours worked without a lost-time injury or illness are awarded certificates signed by our Chief Executive Officer. Small sites that do not attain the level of one million hours worked in a three- year period can obtain a certificate for three or more years worked without a lost-time injury or illness. Milestones achieved in 2008 for hours worked without a lost time injury or illness: 1 million hours: 4 sites 2 million hours: 1 site 3 million hours: 4 sites 4 million hours: 1 site 5 million hours: 1 site 3 years: 1 site 5 years: 2 sites Back to top
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Home Responsibility Our people Health, safety and wellbeing Performance
Corporate Responsibility Report 2008 Performance Performance
Data table
Metric
2001
2005
2006
2007
2008
191.1
196.6
195.4
196.4
187.7
5
1
3
2
2
751
552
565
585
522
16,268
11,610
11,291
11,412
10,706
133
81
98
97
94
Calendar days lost ± illnesses 3
5,304
3,034
5,454
4,135
3,564
Number of injuries without lost time 4
1,079
464
448
393
325
Number of illnesses without lost time 4
315
319
287
260
190
Reportable injury and illness rate
0.72
0.72
0.72
0.68
0.60
Reportable ergonomic injury and illness rate
0.20
0.16
0.18
0.18
0.17
Lost-time injury and illness rate
0.31
.032
0.34
0.35
0.33
17.0
22.8
22.9
26.1
22.0
Fatalities
0
2
0
2
0
Number of injuries and illnesses with lost time
69
98
89
59
74
Calendar days lost
754
1,575
968
924
708
275
375
400
208
Injury and illness ± GSK employees 1 Hours worked (millions) Fatalities Number of injuries with lost time 2 Calendar days lost ± injuries 3 Number of illnesses with lost time 2
Injury and illness ± non-GSK employees Hours worked (million)
Number of injuries and illnesses without lost time
1. The occupational health and safety data cover both our employees and contract workers who are directly supervised by GSK employees. We report a snapshot of injury and illness performance for the year. Cases may be added after the end of the year so prior years may change 2. Lost-time injuries and illnesses are work-related injuries and illnesses that are serious enough to result in one or more days away from work
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3. Lost calendar days are the calendar days, including weekends which employees could not work because of work-related injuries and illnesses. This helps to provide a measure of the severity of injuries and illnesses 4. Reportable injuries and illnesses without lost time are incidents that did not result in time away from work (lost time). They are more serious than first aid but not serious enough to result in lost time
SGS verified
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Case studies
Corporate Responsibility Report 2008 Case studies Diversity and inclusion Women in Science Event We have created a global programme within GSK R&D which encourages and celebrates women in science, the Women In Science Event (WISE). The programme started in 2004 in the UK, bringing women scientists together for a day-long event for networking, education and knowledge-sharing opportunities and has since developed in scope and attendance. In 2007 the annual event was held simultaneously at our sites in Stevenage and North Carolina, with a series of speakers, workshops and simultaneous broadcast of the keynote speaker, an internationally renowned female scientist, to both sites. In 2008 we held events in the UK and at two US sites in North Carolina and Delaware, with a keynote speaker and networking opportunities. We plan hold a further event in late 2009. Additional speaking and networking events are arranged throughout the year in the UK and US, featuring leading female scientists from GSK. Scientific Women¶s Scholarship programme The Scientific Women¶s Scholarship programme has been in place since 1993. This programme has offered a unique combination of scholarships and mentor relationships with professional women scientists. Supported by an endowment fund, the programme is open to 29 US colleges and universities. In 2008, 58 women scholars were selected to participate in the programme with GSK in Research Triangle Park, North Carolina. Fifty-five GSK mentors worked with the scholars to pass on their dedication, energy and passion for science to this new generation of students. The scholars are paired with professional women scientists at GSK who serve as their mentors. These women take the scholars under their wing, provide them with expert advice and share their experiences and lessons learned over the years. GSK volunteer mentors also work to secure internship funding and opportunities for their scholars. The internships offer insight into careers and give the scholars hands-on experience in the pharmaceutical industry. Supporting adult literacy Our manufacturing sites in Nabha and Rajamundy, India, are taking action to improve literacy rates among their employees. At the beginning of 2007, around ten per cent of workers could not read or write and had to use a thumb print instead of signing their name. The sites set a goal for all employees to be able to sign their name. Employees at the Nabha factory took nearly 10,000 hours of training in total, including sessions on how to read and write in Punjabi and English. As a result of the initiative, 154 people learned to read and write and all employees are now able to sign their name. Sessions also included areas such as family relations, AIDS awareness, good health practices and
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
domestic safety and budgeting. The project received an honourable mention in the Employee Attraction, Development and Retention category at the 2008 Multicultural Marketing and Diversity Awards.
Occupational health and safety Contractor competition improves safety during shutdown GSK¶s Slough site, which makes Lucozade and Horlicks powders, holds an annual shutdown to clean and maintain manufacturing equipment. The site¶s EHS team developed a programme to reduce the number of accidents occurring during the shutdown, a time of increased risk to employees and contractors when they undertake non-routine engineering activities in a short period of time. The team reviewed the log of accidents and near-misses from previous shutdowns, and held briefing meetings with supervisors and contractors to raise awareness of risks. It then ran a competition to identify and reward contractors with the best safety performance. The initiative has contributed to a 70% reduction in minor accidents during shutdown, and there have been no reportable incidents since the competition began in 2007. This project won third place in the 2008 CEO¶s EHS excellence awards in the Safety Initiative category.
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Home Responsibility Our people Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders. As you reduce your workforce, how will you ensure that your remaining employees are not faced with additional stress in their jobs? We recognise that stress at work is an important issue. We have established programmes to help individuals and teams deal with stress, and offer other support such as on-site health and fitness centres, flexible working arrangements, family support services and health education. GSK aims to simplify its operating model and create a culture of individual empowerment, where each employee takes responsibility for his or her own work. We are simplifying how we work by removing processes and structures. This reduces the amount of work there is to do in some areas, and as a result fewer people are required. Empowering individuals to make decisions and carry out work without layers of bureaucracy will support this. How will your Operational Excellence programme affect employees? Regrettably, our Operational Excellence programme will result in job losses. We will do everything that we can to support affected employees including providing a competitive severance package and providing outplacement support such as assistance in identifying alternative employment, career counselling and retraining. We will also work hard to ensure the programme does not have a negative impact on the morale of other staff. We have produced a guide for managers with information on how to support employees during the uncertainty, anxiety and stress encountered during major organisational change. Why are there still relatively few women in senior management at GSK? We are pleased that the percentage of women in management has increased incrementally over the last four years. However, we recognise that there is still room for improvement, especially in senior management positions and in roles within historically male-dominated disciplines such as science and engineering. We aim to attract more women to GSK and to support the career development of existing employees through our flexible working programmes. These help employees balance the demands of their personal and professional lives. We also have diversity champions in each business unit as well as employee networks which support career development for women and minority groups at GSK. Your health and safety performance is below the industry average. What needs to improve? We know we need to improve our performance in this area. In 2008, an assessment project identified ergonomics and attitudes to health and safety in the workplace as among the main causes of injuries and illnesses. We will target our awareness and training programmes based on these results. During the year, we also launched a toolkit to help sites assess their risks and identify interventions. This has been adopted by our Pharmaceutical manufacturing business and behaviour-based safety programmes are now planned in all sites. What progress have you made toward your µrespirator-free¶ target? Results of baseline monitoring of the level of exposure to chemicals in the workplace are being used to define where new and upgraded engineering controls are needed to meet the target for employees in 80% of
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operations to be able to work without needing to wear respiratory protection. We have reached 42% of operations that have achieved this level of engineering control pending completion of full verification monitoring. We continue to upgrade engineering controls to achieve µrespirator free¶ levels of control but for situations where engineering controls are not possible we will make sure appropriate respiratory protective equipment is used.
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Home Responsibility Human rights
Corporate Responsibility Report 2008 Human rights We are committed to upholding the UN Universal Declaration of Human Rights, the OECD Guidelines for Multi-National Enterprises and the core labour standards set out by the International Labour Organization. We are a signatory to the UN Global Compact, a voluntary global standard on human rights, labour, the environment and anti-corruption. We believe that governments have a responsibility to define and enforce a legal framework for human rights in accordance with international laws and agreements, such as the Universal Declaration of Human Rights. Businesses also have responsibilities. We work hard to uphold human rights within our sphere of influence, which includes employees, suppliers, communities and society. We have most direct control over human rights in our own operations and can also influence our supply chain and wider society. As a marketer of medicines, we strive to make them as widely available as possible while running our business in a sustainable way. High standards of human rights are important to GSK because they: Help us get the best from our employees Support our relationships with communities near our sites Ensure supplier contracts run smoothly and provide a reliable supply of high-quality products Protect our reputation Human rights are relevant to many of the issues covered in this report. This section gives an overview of our approach. More information on GSK and human rights
See the human rights clauses included in our contracts with suppliers Read more about our supply chain Read about our efforts to improve access to medicines Read about our investment in local communities Read about our employment practices Read our position statement on the Convention on Biological Diversity
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Home Responsibility Human rights Employees
Corporate Responsibility Report 2008 Employees Our employment standards on issues such as diversity, equal opportunities and health and safety protect employees¶ human rights. As an employer we are: Committed to providing a fair salary and good employment conditions Committed to providing a healthy, safe and secure workplace for all employees and contractors Opposed to discrimination at work and committed to promoting respect for diversitys Committed to promoting the personal development and dignity of every employee Respectful of employees¶ right to join an independent trade union and freedom of association Opposed to all forms of slavery and exploitative child labour and will work with appropriate partners to address this problem responsibly wherever we encounter it. Employees can report any concerns to their supervisor or line manager, to human resources or to our ethics and compliance office. They can also use our Global Confidential Reporting line. Read more about our employment practices.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Human rights Suppliers
Corporate Responsibility Report 2008 Suppliers As a buyer of raw materials, manufactured goods and services around the world, we require all our suppliers, contractors and business partners to meet the same standards on human rights as GSK. We will not knowingly use suppliers who are responsible for human rights infringements. We conduct regular audits of existing suppliers and only engage new suppliers that meet our expectations. Human rights clauses are included in our contracts. We consider human rights issues during routine interactions with critical suppliers (contract manufacturers and suppliers that present the greatest risk to GSK in one or more key risk areas). EHS audits of potential new and existing critical suppliers also include questions which help us identify potential breaches of the human rights clauses included in supplier contracts. Suppliers are asked for information on policies and practices relating to: Age limits for employees Discrimination against employees and the local population Prevention of abuse of individuals Wages, benefits and working hours (whether they meet the legal minimum) Rights for workers to organise and recognition of worker organisations These questions do not contribute to the EHS audit score, but may be a reason not to progress business with a supplier. Read more about our supply chain.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Human rights Communities
Corporate Responsibility Report 2008 Communities We respect and promote the rights of all those in the communities near our operations. For example:
Local communities GSK aims to have good relationships with all the communities around our sites and to operate in ways that do not infringe their human rights. We seek to minimise our impacts on the local environment and operate our sites safely. We aim to bring social and economic benefits to areas where we have a presence. Read more about our investment in local communities
UN Convention on Biological Diversity (CBD) The Convention on Biological Diversity provides a framework for the conservation and sustainable use of biodiversity. It also promotes fair and equitable sharing of the benefits arising from the use of genetic resources. GSK supports the CBD¶s role. We are not currently involved in any bioprospecting activity. As a result, we have no access and benefitsharing agreements in place. It is possible that in future we may undertake development work using natural genetic resources indigenous to a particular country. In that instance, access to those resources would be obtained in accordance with the CBD, as reflected in local laws. We would ensure that relevant parties received agreed benefits from the use of the resources, for example monetary payments. Read our position statement on the Convention on Biological Diversity Read our position on protecting biodiversity.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Human rights Society
Corporate Responsibility Report 2008 Society The UN Declaration of Human Rights states that µeveryone has the right to a standard of living adequate for the health and well-being of himself and of his family, including medical care¶. Improving healthcare is one of the greatest challenges we face, particularly in the developing world. GSK contributes to healthcare in the developing world by discovering new treatments and vaccines. We also make a wide range of our products more affordable in developing countries through preferential pricing and voluntary licence agreements with generic manufacturers. We engage with governments, multilateral agencies, NGOs and other pharmaceutical companies to help improve access to medicines. Read more about our efforts to improve access to medicines and our community investment initiatives.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Human rights Activities in sensitive countries
Corporate Responsibility Report 2008 Activities in sensitive countries Some stakeholders are concerned about GSK¶s business activity in countries with poor human rights records, such as Burma (Myanmar), North Korea and Sudan. We share the UN¶s belief (see box) that people should not be denied access to medicines because of the regime operating in their country. We aim to provide medicines and vaccines in all countries that need and wish to purchase them. We observe any trading controls required by law in the countries where we operate. In many nations our long-standing commitment and presence pre-date their oppressive regimes and the subsequent introduction of measures such as trade embargoes. During periods of government-imposed trade embargoes, we have continued operations (subject to any specific legal restrictions) due to the need for our products. In sensitive countries, as in all countries where we operate, we support and are committed to upholding the Universal Declaration of Human Rights and the core standards set out by the International Labour Organization. We observe all local laws and regulations. UN statement on the right to the highest attainable standard of health
Paragraphs relating to access to medicines in sensitive countries: Paragraph 12: µHealth facilities goods and services must be accessible to everyone without discrimination, within the jurisdiction of the State party.¶ Paragraph 41: µParties should refrain at all times from imposing embargoes or similar measures restricting the supply of another State with adequate medicines and medical equipment. Restrictions on such goods should never be used as an instrument of political and economic pressure¶. Paragraph 42: µWhile only States are parties to the Covenant and thus ultimately accountable for compliance with it, all members of society - individuals, including health professionals, families, local communities, intergovernmental and non-governmental organizations, civil society organizations, as well as the private business sector - have responsibilities regarding the realization of the right to health. State parties should therefore provide an environment which facilitates the discharge of these responsibilities.¶ Read the full UN statement for the right to the highest attainable standard of health.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy
Corporate Responsibility Report 2008 Public policy and patient advocacy The pharmaceutical industry is highly regulated. Government policy and legislation can have a significant impact on our business so it is important that we engage with governments and other stakeholders in the legislative and policy process. Through our public policy activity we work towards legislation and policy that encourage scientific innovation and balance the interests of business with those of other stakeholders. We also work with patient groups to help give their members a voice in the healthcare debate. We believe that we conduct our advocacy work responsibly and make a valuable contribution to the debate on public policy issues that impact our business, particularly those relating to research and development, the use of pharmaceuticals and healthcare. We aim to increase stakeholder trust in GSK and, by being transparent about our lobbying and public policy work, to address concerns from some stakeholders that the pharmaceutical industry has too strong an influence over governments. We publish our annual public policy activity on this website and report on our memberships of trade associations, our political contributions and US lobbying expenditures. We also publish information on our work with patient groups, including details of the funding we provide. We provide information on our approach to working with doctors and healthcare professionals in the Research practices and Ethical conduct sections of this website. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Our approach to external affairs
Corporate Responsibility Report 2008 Our approach to external affairs Employees involved in public policy work must abide by our Employee Guide to Business Conduct which is based on three principles: Partnership: we are committed to working with governments and regulatory authorities in a constructive way Communication: as well as giving our views, we take on board any concerns from external audiences. This enables us to assess and improve our business practices Integrity: we base our public policy work on research, analysis and facts. We respect other opinions and look for constructive solutions. All of our external affairs work must be in line with our Code of Conduct and other relevant policies including those related to competition law, preventing corrupt practices and political contributions We have external affairs teams in our major regions who monitor proposed legislative reforms and policy developments. They meet regularly with government officials and other stakeholders, for example multilateral organisations and NGOs, to explain our views on a range of public policy issues. We tailor our approach to suit different cultures and political traditions in the countries where we engage in the public policy process, while ensuring that our position in these discussions is fully consistent with our public policy statements. We ensure that the standards set out in our Guide to Business Conduct are applied globally. Lobbying on issues affecting the whole pharmaceutical industry is sometimes conducted through trade associations. We may also hire professional lobbyists to support our public policy work. We have a Political Contributions Policy governing our contributions to political candidates and parties.
Trade associations GSK is a member of many trade and industry organisations, including: Association of the British Pharmaceutical Industry (ABPI) BioIndustry Association (BIA) Biotechnology Industry Organization (BIO) British Pharma Group (BPG) Confederation of British Industry (CBI) European Federation of Pharmaceutical Industries (EFPIA) International Chamber of Commerce (ICC) Intellectual Property Owners Association (IPO) International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Japan Pharmaceutical Manufacturers Association (JPMA) Organisation of Pharmaceutical Producers of India (OPPI) Organization For International Investment (OFII) Pharmaceutical Research and Manufacturers of America (PhRMA) It is important that any lobbying conducted through trade associations reflects our policies and values. We work with other members to help set policies and may also attend lobbying meetings with governments and other stakeholders.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Sometimes we do not share the same views on a particular issue as other members of a trade association. If a trade association adopts a public policy position that we do not agree with, we will not participate in advocacy activity related to that subject. Senior GSK managers sit on the boards of the majority of industry trade associations of which we are members and raise any concerns we may have about a particular advocacy position. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Public policy activity in 2008
Corporate Responsibility Report 2008 Public policy activity in 2008 We engage with governments and other stakeholders on a wide range of issues that affect our industry. These are some of the key issues we engaged on during 2008: Access to healthcare and disease prevention Research practices Patient safety Intellectual property Pricing and competitiveness We publish our position on key issues relating to corporate responsibility, including: Access to medicines in developing countries Research and development Intellectual property The environment Public health Competitiveness Pricing, reimbursement and market access We are happy to discuss our position on these or any other issues with legitimate parties. Contact our corporate responsibility team at [email protected]. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on healthcare and disease prevention
Corporate Responsibility Report 2008 Advocacy on healthcare and disease prevention Global activity Safeguarding timely and unrestricted access to influenza viruses Organisations engaged: World Health Organization (WHO), key developed and developing country governments (including countries affected by the H5N1 strain), EU institutions Industry associations involved: EFPIA (EVM), IFPMA (IVS), PhRMA GSK position: The influenza virus is very unstable and can mutate quickly. Governments must remain vigilant to the emergence of new strains of the virus and must share virus strains freely with other governments. The free sharing of viruses is in the best interests of global public health as it enables governments to develop vaccines which may prevent an influenza pandemic. The WHO¶s Global Influenza Surveillance Network recommends the content for influenza vaccines twice a year and will act as a global alert mechanism in the event of a pandemic. The international community should unconditionally support the Network, which relies on receiving information on virus strains from governments. Despite the importance of timely and unrestricted access to viruses, Indonesia stopped sharing influenza viruses with the WHO in 2007 insisting on µaccess and benefits¶ in exchange for viruses. The international community ± including the vaccine industry ± spent much of 2008 finding a way to help developing countries prepare for a pandemic. Some progress was made towards agreeing an effective solution at the InterGovernmental Meeting in Geneva in December 2008. GSK is hopeful that a solution that will ensure speedy access to the pandemic virus while assuring developing countries of the support they require to secure access to pre-pandemic and pandemic vaccines will be agreed at the next IGM in May 2009.
US activity Investment in chronic disease prevention and treatment Organisations engaged: US Department of Health and Human Services, Office of the First Lady, US Congress, White House, state legislators, Governors¶ Offices, various state health agencies Industry associations involved: PhRMA GSK position: Chronic diseases such as diabetes, heart disease and lung disease account for threequarters of healthcare spending. Relatively little is invested in prevention even though many chronic diseases and their costly complications are preventable and increasingly manageable. We are advocating a three-part approach to achieving lower-cost, higher-quality healthcare: increasing prevention, improving treatment, and accelerating research into better treatments for chronic disease. Healthcare providers need incentives to promote preventative services that address major causes of chronic disease such as obesity and smoking. Healthcare policy needs reform to better encourage and reward medical research into improved treatments for costly, unmet medical needs such as Alzheimer¶s disease. Preventing and better managing chronic diseases will reduce overall healthcare costs in the long term. Supporting a petition to protect Americans from fraudulent weight loss claims Organisations engaged: US Food and Drug Administration Industry associations involved: None. See below for the healthcare associations involved.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
GSK position: In the US, two-thirds of adults are overweight or obese, increasing their risk of illnesses such as cancer, heart disease and type 2 diabetes. There are dozens of dietary supplements on the market in the US which manufacturers claim can help people to lose weight. Most of these claims are not reviewed by the Food and Drug Administration (FDA) and are not supported by credible scientific evidence. Ineffective weight loss products can prevent people getting the support they need to lose weight. The US Federal Trade Commission¶s Consumer Fraud Survey recently highlighted that there were more victims of fraudulent weight-loss products, 4.8 million American consumers, than any of the other frauds covered by the survey. GSK manufactures alli, the only over-the-counter weight loss product that has gained FDA approval for safety and efficacy. In April 2008, GSK and three research and advocacy organisations (the American Dietetic Association, the Obesity Society and Shaping America¶s Health) submitted a citizen¶s petition to the FDA, asking it to provide greater protection for Americans from fraudulent weight loss claims. The petition requests that the FDA treats weight loss claims in the same way as unsubstantiated claims of efficacy against disease, which are not permitted under the Dietary Supplement Health and Education Act. The petition calls for the FDA to require rigorous scientific evidence for any such claims. It also aims to raise awareness and educate the public about the issue of fraudulent weight loss products. In a separate development, in January 2009 the FDA demanded the recall of a large number of weight-loss supplement products and warned a number of companies that they may be liable for criminal charges. Among the FDA¶s complaints against 69 supplement products in the US was the illegal inclusion of regulated, unapproved or withdrawn prescription pharmaceuticals, including sibutramine and rimonabant (weight loss), phenytoin (anti-seizure) and phenolphthalein (laxative, previously withdrawn by the FDA due to carcinogenicity). GSK supports and will continue to work with the FDA to help protect the public from false and unsubstantiated weight loss claims and possibly unsafe products.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on research practices
Corporate Responsibility Report 2008 Advocacy on research practices We regularly engage with policy makers and other stakeholders on issues relating to research practices and the research environment. Read more about research practices.
Global activity Advocacy on revisions to the Declaration of Helsinki Organisations engaged: World Medical Association, American Medical Association Industry associations involved: BIO, IFPMA, PhRMA GSK position: The Declaration of Helsinki sets out the ethical principles for the conduct of research on human subjects. The Declaration was revised in 2008 by the World Medical Association. We urged the World Medical Association to resist changes that make the document more detailed and prescriptive, because we believe they create confusion and conflict with other, more detailed guidance such as ICH guidance on Good Clinical Practice. Shaping the scope of the International Regime on Access and Benefit Sharing Organisations engaged: Secretariat to the Convention on Biological Diversity (CBD), Ad Hoc Working Group on Access and Benefit Sharing, UK DEFRA, DG Trade (European Commission), national European governments, US government. Industry associations involved: BIO, BPG, EFPIA, ICC, IFPMA, PhRMA GSK position: The Convention on Biological Diversity (CBD) was signed in 1992. It has three main goals, including the fair and equitable sharing of benefits arising from the use of µgenetic resources¶. GSK believes that the best way to achieve the CBD¶s access and benefit-sharing objectives is for countries to introduce national laws governing access to their genetic resources and for mutually agreed contracts to define how any benefits arising from their use should be shared. This approach allows national governments the flexibility to develop guidelines that will best serve their national interests, and enables users of the guidelines to reach agreements that are appropriate to each individual case. Notwithstanding GSK¶s support for national legislation we recognise the CBD¶s mandate to µelaborate and negotiate an international regime on access and benefit-sharing¶. We believe that the resulting regime, currently under discussion within the CBD, should be consistent with the CBD¶s treaty and objectives. It should create no new obligations for CBD signatories and should not be applied retrospectively. It should provide guidance to governments and other CBD members on how to achieve access and benefit-sharing objectives, rather than prescribing rules. It should adopt a sectoral approach and not seek to enforce a µone size fits all¶ solution on all industries. It should apply only to genetic resources as defined in the CBD, not a broader class of materials. It should not extend to human genetic resources, nor to derivatives, or pathogens. Read our position statement on the Convention on Biological Diversity.
European activity Advocacy on the European Animal Directive Organisations engaged: European Commission Industry associations involved: ABPI, EFPIA
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
GSK position: The European Animal Directive, originally introduced in 1986, governs the use of animals for experimental or other scientific purposes. It aims to establish a framework for all animal research activities within the EU. The European Commission has published a draft revision of the Directive which controls the use of laboratory animals and sets minimum standards for their housing and care. GSK welcomes the review of the Directive and recognises the need for it to be revised to reflect advances in animal welfare and science. We welcome many of the recommendations in the draft revision, many of which are already integrated into our current practices. For example, we welcome the rules relating to the replacement, reduction and refinement in the use of animals in research (known as the 3Rs), and the need for a permanent or standing ethic review body in the establishments that use animals in research. It is essential that any legislative changes achieve high animal welfare standards while supporting an environment that allows research that leads to new medicines and vaccines to meet patients¶ needs. In this regard we have a number of concerns related to the restrictions on the use of non-human primates to those diseases that are considered life-threatening or seriously debilitating and the reuse of surgically instrumented animals which is likely to result in an increased number of animals where procedures are mild to moderate. Read our position statement on use of non-human primates in research. Supporting a new approach to pharmacovigilance in the EU Organisations engaged: European Commission, European Medicines Agency, UK government Industry associations involved: ABPI, EFPIA GSK position: GSK seeks a new approach to pharmacovigilance regulation in the EU that will allow pharmaceutical companies and regulators to focus their resources on safety evaluation activities instead of compliance with unclear and complex regulatory demands. New pharmacovigilance legislation should contain clear and concise provisions to simplify, strengthen and provide legal certainty to the EU legislative framework for pharmacovigilance. Specifically, it should: Contain a single set of simplified rules, and a single reporting point, for adverse drug reactions in the EU Require the reporting of all serious cases when an electronic reporting system is implemented Contain clear and flexible provisions that allow individual companies to appoint the number Qualified Persons for Pharmacovigilance (QPPVs) they require Provide consistent standards for inspections of company pharmacovigilance departments by EMEA and EU member state authorities
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on patient safety
Corporate Responsibility Report 2008 Advocacy on patient safety US activity Legislation on prescription medicine imports Organisations engaged: US Department of Health and Human Services, Food and Drug Administration (FDA), US Congress, state Boards of Pharmacy, state legislators, Governors¶ Offices Industry associations involved: BIO, PhRMA GSK position: Current US law prevents prescription medicines from being imported to the US unless they have safety and cost savings certifications from the Secretary of Health and Human Services. Pending legislation would remove the safety and savings certification requirements, making it easier to legally import medicines. This would undermine the FDA¶s ability to protect the US distribution system from counterfeit and unsafe medicines that could harm patients. There is also no guarantee that consumers would save any money, as the Department of Health and Human Services has found that third -party payers such as insurance companies are most likely to benefit. GSK supports safer alternatives to help patients afford their medicines. The Partnership for Prescription Assistance (PPA), for example, gives access to more than 475 public and private patient assistance programmes, for patients who lack prescription drug coverage. Read more about GSK¶s Patient Assistance Programs.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on intellectual property
Corporate Responsibility Report 2008 Advocacy on intellectual property US activity US patent system reform ± Federal legislation Organisations engaged: Patent and Trademark Office (PTO), US Congress Industry associations involved: BIO, Coalition for 21st Century Patent Reform, PhRMA GSK position: A patent law framework that provides business certainty over a long period and promotes investment is essential to the research-based pharmaceutical industry and a wide range of other manufacturers that have long lead times from research to market. The US Congress is considering patent reform legislation that could have a negative effect on the current framework. Specifically, the proposals fail to strike an appropriate balance in the areas of restricting abuse of the inequitable conduct doctrine (which encourages infringers to try to prove in litigation that a patent was improperly obtained so that a completely valid patent may be held µunenforceable¶) and the allocation of damages for infringement. In addition, giving the PTO substantive rule-making authority removes responsibility for establishing substantive patent law from Congress and innovation policy from the public debate. GSK is working with a coalition of research-based companies, manufacturers, universities and small inventors to promote US patent reform that stimulates investment in research and strengthens the patent system. We support patent reforms that are clear, provide business certainty, improve the quality of patents and remove subjectivity in litigation issues.
Asian activity Compulsory licensing in Thailand Organisations engaged: Thai government including the Thai Ministry of Public Health; academics, NGOs and members of the business community in Thailand; World Health Organization; international NGOs; US and EU member state Industry associations involved: BPG, EFPIA, IFPMA, PhRMA, PReMA GSK position: In late 2006 the Thai government issued compulsory licences on three pharmaceutical products. Four more compulsory licenses for oncology products were announced just prior to the previously elected government leaving office in early 2008 of which two were implemented. We support the Thai government¶s public health goals and want to help improve health outcomes for people in Thailand. Compulsory licences are a legitimate policy option for the Thai government but they should not be used as a routine policy tool or for commercial purposes. Rather than unilaterally using compulsory licences to increase access to medicines, we believe it is more effective to engage in dialogue with industry and other stakeholders to find sustainable ways to address healthcare issues, including access to medicines. We hope to reinforce this dialogue with governments and other stakeholders in the future. Healthcare and intellectual property in India Organisations engaged: Relevant agencies in the Indian government; members of the pharmaceutical industry and the wider business community in India; Indian academics and civil society representatives; US and EU member state governments; European Commission Industry associations involved: BPG, EFPIA, OPPI, PhRMA
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GSK position: We believe that India¶s tremendous strengths in science and pharmaceuticals, coupled with its rapid economic growth, offer the government an opportunity to tackle some fundamental characteristics of its healthcare system and policy base. Further improvements in India¶s intellectual property (IP) regime to the level provided in the EU and US could further encourage investment in collaborative R&D. Issues of IP rights are not the fundamental barrier to access to healthcare and we believe that reform and increased investment in the Indian healthcare system should be a priority. We want to be active partners in addressing these challenges.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on pricing and competitiveness
Corporate Responsibility Report 2008 Advocacy on pricing and competitiveness European activity Guiding principles for relative effectiveness assessments and pricing Organisations engaged: EU member states, the European Commission, stakeholder representatives participating in the EU¶s High Level Pharmaceutical Forum Industry associations involved: EFPIA, EuropaBio GSK position: Government funding decisions are often based on an assessment of a medicine¶s clinical or cost effectiveness. We believe that these value assessments should be conducted transparently and in a timely manner and all key stakeholders should be able to submit evidence for the assessments. Governments should allow greater pricing flexibility when the long-term value of a medicine is not certain at launch. GSK, representing EFPIA, strongly supported the Good practice principles for relative effectiveness assessments which were developed within the framework of the EU¶s High Level Pharmaceutical Forum (HLPF). These were adopted in 2008 along with the Guiding principles for good practices implementing a pricing and reimbursement policy. EFPIA¶s Health Technology Assessments principles, which the industry has previous adopted and that GSK helped to develop, are aligned with the principles adopted by the HLPF. Improving regulations that impact on the pharmaceutical industry¶s competitiveness in the UK Organisations engaged: UK government and the European Commission Industry associations involved: ABPI, CBI, Institute of Directors GSK position: The pharmaceutical industry is one of the most highly regulated industries in Europe. GSK supports strong regulation but has been working with the UK government and the European Commission to propose ways to simplify regulations while achieving the same policy goal. This aligns with the aims of the UK government and European Commission to reduce the regulatory burden placed on industry. GSK submitted a series of 50 proposals to the UK government for simplification of existing regulations. We also made a similar submission to the Commission, focusing on regulations that originate at a European level.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Political contributions and lobbying expenditures
Corporate Responsibility Report 2008 Political contributions and lobbying expenditures In late December 2008, GSK announced a new global policy to voluntarily stop all corporate political contributions. Prior to this, GSK made political contributions with corporate funds in countries where they were authorised by law and were culturally appropriate, such as the US and Canada. The new policy ensures that no such contributions will be made in the future. Contributions to political parties or other political organisations in the European Union were prohibited by GSK policy prior to this change. See the corporate governance section of our Annual Report for more information. Prior to this policy change, in 2008 we contributed 347,000 to political organisations in the US and Canada. In the rest of the world, contributions have been very rare and of low monetary value. These contributions were agreed by local management and approved by GSK¶s international legal operations and corporate government affairs department. All contributions were made in compliance with local laws and customs.
Contributions in the US In the US, corporate contributions to party affiliated committees and candidates running for federal office are prohibited by law. State and local political campaigns are financed through a variety of sources including contributions from companies, individuals, NGOs and local campaign committees. By supporting pro business candidates, corporate contributions are an accepted and legal means for corporations to have a voice in the political debate. However, to ensure that there is no implication whatsoever that such contributions provide GSK with any special privileges, the company changed its policy in late December 2008 to prohibit any corporate contributions to political candidates. Contributions to state candidates In 2008 prior to the change in policy, GSK donated 319,000 to candidates for state-held offices. Contributions were only made where permitted by law and were not made on the basis of political party. Contributions were made to candidates who support an environment that appropriately rewards high-risk, high-investment industries and who work to preserve free market principles and intellectual property rights. We made approximately 46 per cent of our contributions to Republican candidates and 54 per cent to Democratic candidates. All states publish information disclosing the names of contributors and the amount of contributions that are at or above an established threshold. Political Action Committee contributions In accordance with the Federal Election Campaign Act, GSK established a Political Action Committee (PAC) that facilitates voluntary political contributions by eligible employees. The PAC is not controlled by GSK. Decisions on the amount and recipients of contributions are made by participating employees exercising their legal right to pool their resources and make political contributions. All PAC contributions are voluntary and contributions are subject to strict limitations. For example, the GSK PAC may not contribute more than $5,000 per election to an individual candidate for federal office. The PAC is run by a governing board of participating GSK employees from across the company. As required by law, PAC contributions are reported to the Federal Elections Commission (FEC). In 2008, the GSK employees¶ PAC contributed 539,359 - 58 per cent to Republicans, 40 per cent to Democrats and two per cent to unaffiliated or other party candidates running for state and federal offices.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Contributions in Canada In 2008, GSK donated 28,000 in Canada to political candidates in those provinces where it is legal.
Lobbying expenditure Europe In December 2008, GSK signed up to the European Commission¶s new code of conduct and the voluntary register of organisations working to influence European Union institutions. In the µtransparency register of interest¶, we declared the costs associated with lobbying of the EU institutions to be in the range of ¼750,000800,000 in 2008. This includes running of the Brussels advocacy office, salaries, external events and educational materials. This figure takes into account the proportion of employee time spent on interest representation. US We report our US lobbying expenditures to the US Congress in accordance with the Lobbying Disclosure Act 1995. We spent $6.99 million in federal lobbying activities in the US during 2008. This includes the costs of salaries and benefits for all employees registered to lobby the US government; use of lobbying consultants; support for lobbying contacts such as planning activities and research; running the GSK Washington DC government affairs office; support staff; and the portion of trade association fees associated with federal lobbying. We also report our state lobbying expenses, in line with applicable state laws. Contributions to policy groups GSK contributes to various groups which provide a forum for policy analysis and debate. This includes think tanks in a number of countries, and '527' organisations in the US.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Patient advocacy
Corporate Responsibility Report 2008 Patient advocacy Patient groups are non-profit organisations founded by patients, care-givers, family members and health professionals. They provide their members with information about their condition and guidance on how to live with their disease. They engage with healthcare providers, governments and the media to promote improved treatment and services for patients and campaign for change on issues that affect patients¶ and carers¶ lives. Some carry out vital research into the causes and potential treatments for specific conditions. GSK works with a wide range of patient groups in disease areas such as cancer, asthma, diabetes, Alzheimer¶s disease, multiple sclerosis and HIV/AIDS. GSK and patient groups share a common concern that healthcare systems should focus on preventing, treating and managing disease. Both parties believe that patients should have access to quality medicines, services and information on disease. Patient groups are important stakeholders for GSK and we engage with them as part of our commitment to be a patient focused company. Our relationships with patient groups are mutually beneficial. They help us to better understand patient needs and their illnesses. We work with patient groups to strengthen their support for patients throughout their illness, from diagnosis to chronic treatment and end -of-life care. We also help these groups give patients the ability to have their voice heard in the healthcare debate, alongside other stakeholders.
Our approach We support patient groups across the world in a number of different ways. These include: Providing core funding to support the day-to-day running of the group One-off donations to help patient groups conduct a specific event or activity, for example a breast cancer awareness day Educational support Training staff in management skills and disease education Working together on disease awareness/prevention projects Our relationship with each patient group is defined by a written agreement specifying how the group will use our funding to benefit its members. Some stakeholders are concerned that pharmaceutical companies use patient groups as a way of marketing their products. Our support for patient groups is about the bigger agendas that dictate whether or not new medicines are made available to patients, and whether patients have access to the kind of treatments that they need. We are committed to maintaining the highest ethical standards and transparency in this area. We have developed detailed guidance and Standard Operating Procedures (SOP) for employees in each of our major regions. These policies, used in conjunction with GSK¶s patient advocacy manual, ensure that GSK employees who work with patient groups comply with applicable laws and regulations and our standards. Read a summary of our SOP. All employees, and outside agencies working for GSK that are likely to interact with patient groups, must abide by our guidelines and SOPs. We provide training so that our employees understand our requirements. For example in 2008, around 70 marketing employees in the US attended a webinar on our guidelines and SOPs.
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Our patient advocacy teams in Europe and our Asia Pacific, Japan and Emerging Market region coordinate interaction with patient groups and adherence with our policies and global principles. In the US, patient advocacy is decentralised across a number of functions including state government affairs, R&D, communications and marketing, but is coordinated by the state government affairs group. Employees in all regions can access our patient advocacy resource intranet site. In Europe, we also publish a newsletter to raise employee awareness about internal and external developments relating to patient groups. In 2007, we conducted a review of departments that have relationships with patient groups in the US. This led to the development of an interactive patient group database that tracks our relationships with patient advocacy groups and the projects we support. This will enable employees to learn about past interactions with patient groups and the type of projects supported. It will help us to allocate resources to patient groups more efficiently. The database will be launched in 2009.
Encouraging independence We believe that patient groups should be independent and we encourage them to seek financial support from as wide a range of organisations as possible. We ensure that the funding we give to patient groups is appropriate to their size. Our guidelines state that GSK funding should make up no more than 25 per cent of a group¶s overall income. In the vast majority of instances the actual percentage is much lower. We allow some exemptions to the 25 per cent cap as some of the groups supported have limited incomes, so a small donation (for example 1,000) would exceed the limit, and because some groups have difficulty attracting funding because of the nature of their activity (for example, providing needle exchange for drug users). These cases must be approved by the general manager of each local operating company. We also encourage patient groups to seek funding from multiple sources and we hold workshops on how to make funding applications.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Patient advocacy Transparency
Corporate Responsibility Report 2008 Transparency We believe that being transparent about our support for patient groups helps build trust with our stakeholders, including the groups themselves. We publish information on all our work with patient groups in our Europe and Asia Pacific, Japan and Emerging Markets regions, as well as information on our support for patient groups working globally, including details of the funding received. See details of our funding for patient organisations. We were the first pharmaceutical company to publish this level of information and it goes beyond industry codes of practice that at most require a list of the groups funded. Detailed information for GSK Australia and Canada can be found on their websites. In the US, from February 2009 we will report educational and charitable grants provided to health -related organisations, including hospitals, teaching institutions and patient advocacy groups. The report will be updated quarterly. See details of our funding for patient organisations Working with patient groups
Our Standard Operating Procedures state that: Any involvement with a patient organisation must be declared and transparent GSK must neither seek patient organisation endorsement for its medicines, nor pay patient groups to endorse GSK services Medicines must not be promoted to patient organisations GSK must not create patient organisations, must not be the sole funding sponsor of a patient organisation, and should not provide more than 25 per cent funding to patient organisations. Exceptions may be allowed in the case of rare disease focus or start-up funding up to 50 per cent. However, must be agreed with directly with the local country or region general manager or head of regional government affairs GSK must not seek a direct return on investment from the funding of a patient organisation Any information on GSK pipeline compounds must be factual and non-promotional and provided to patient organisations as part of a scientific dialogue It is acceptable for GSK clinical trials or medical personnel to work with patient organisations to ensure optimal clinical trial recruitment, and to consult them on clinical trial design and protocols GSK must not directly sponsor patient organisation representatives to attend medical congresses, conferences and other healthcare professional events. Exceptions include where the representative is invited to speak at the conference or where the medical congress has a specific workstream designed for patients. GSK may sponsor representatives to attend non-medical congresses GSK may pay a modest honorarium or speaker fee to the patient organisation that an advisory board member or speaker represents Any third party working for GSK on a given project must be fully transparent about this relationship when interacting with a patient group on the project Back to top
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Home Responsibility Public policy and patient advocacy Patient advocacy Understanding patients
Corporate Responsibility Report 2008 Understanding patients To help us better understand patient needs we have set up advisory boards in the US and Europe that include representatives from a wide range of patient groups. The advisory boards have independent chairs, meet regularly and are attended by senior GSK managers. The boards enable the voice of patients to be heard at the highest levels of GSK. They also allow us to access the views of patient groups and we seek feedback on subjects such as clinical trials, pharmacogenetics, information provided to patients and ethical issues. In all regions we invite speakers from patient groups to meet GSK employees, including scientists, researchers and marketers, to discuss issues affecting their members. As well as improving our understanding of patient needs, it shows GSK employees the difference their work can make to people¶s lives. Read about how our Focus on the Patient initiative is helping us to better understand patient needs and develop better medicines. We also engage with patient groups through Patient Advocacy Leaders¶ Summits (PALS). These bring groups together to discuss health policy concerns, develop new skills and/or ways to expand their influence. PALS can also give patient groups the opportunity to learn about GSK and tell the company how it can better support their work. In 2008 we were involved in running a total of 33 summits: 14 in nine European countries, one in Japan and 18 throughout the US. Discussions at the 2008 PALS focused on a broad range of issues, including: Efforts to establish patient-centred healthcare (Japan) Availability of medicines and the role of patients and patient organisations (Netherlands) Clinical trials (Germany) Healthcare as a political priority and healthcare funding impacts on patients (Estonia) Healthcare system reform and patient rights (Czech Republic) Healthcare financing and patient access to healthcare in an economic downturn (Latvia) Patient input to the national strategy for cancer (Bulgaria) Communications strategies for patient associations (France) Importance of innovation, intervention and prevention in health care reform (US) In 2008, GSK co-sponsored the European Patient Forum¶s annual conference in Brussels with the pharmaceutical company Pfizer. This brought together approximately 100 patient groups and other stakeholders to exchange ideas about improving healthcare and the role of patient organisations. We intend to hold a further 20 PALS summits in the US in 2009 and in Europe we will support a similar number of PALS as in 2008. We also plan to have several regional PALS meetings in our Asia Pacific and Emerging Markets regions.
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Home Responsibility Public policy and patient advocacy Patient advocacy Developing industry standards
Corporate Responsibility Report 2008 Developing industry standards We are taking a leadership approach in developing industry standards for engaging with patient groups. In the US, we are working with the industry trade group PhRMA to develop guidelines for its members on working with patient groups which will be launched in May 2009. We also helped the National Health Council to develop guidelines for patient groups to follow when working with companies. Patient group members of the Council are required to follow the guidelines, which were launched in 2008. Update August 2009
Since the publication of this report, our work with PhRMA to develop guidelines on working with patient groups has stopped. All companies did not agree on the need to develop industry wide guidelines, however PhRMA supports the National Health Council guidelines for patient groups when working with companies. GSK remains committed to developing industry standards for engaging with patient groups. In Europe, we were closely involved in the development of the first EFPIA code of practice on relationships with patient organisations, which came into effect in July 2008. The code bears a close resemblance to GSK¶s policies on working with patient groups, and a senior GSK manager chaired the EFPIA Patient Relations Network that originally developed the code. The EFPIA code contains many of the requirements of GSK¶s policies. It states that companies cannot promote their medicines to patient groups, there must be written agreements in place for all interactions with patient groups, and companies must list all patient groups they work with and describe the nature of any support. We have been involved in training other companies to prepare to implement the code at the European level and locally in countries including Finland and Germany. Back to top
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Home Responsibility Public policy and patient advocacy Patient advocacy Advocacy in 2008
Corporate Responsibility Report 2008 Advocacy activity in 2008 Here we describe some of the advocacy activities we undertook in 2008 in partnership with patient groups. Global recruitment for lung cancer vaccine clinical trial We partner with the Global Lung Cancer Coalition (GLCC), a body comprising 23 not-for-profit groups from around the world, that promotes understanding about lung cancer and advocates for patients¶ right to early detection, better treatment and supportive care. GLCC members are also committed to campaigning for more lung cancer research and an increase in enrolment of patients into clinical trials. As with many other new therapy trials, the GLCC network helped us in the recruitment of patients for the phase lll clinical trial of our therapeutic lung cancer vaccine. We raised awareness about the trial through GLCC members who disseminated information to lung cancer patients, calling for those who had recently undergone surgery to ask their doctors about entering the study. We hope that the vaccine, to be given to lung cancer patients after surgery, could help stop tumours returning and reduce the effect of the disease. Chronic hepatitis B in Asia Pacific In 2008 we continued our campaign in Asia Pacific to raise awareness about chronic hepatitis B, increase the number of people being tested and diagnosed, and improve compliance with antiviral medication. Around 300 million people in the region live with the disease. GSK and a patient consortium developed a patient engagement programme and created resources to support healthcare professionals and encourage patients to adhere to their treatment regimes, including an SMS service that reminds patients about how to manage their condition. We piloted the programme and resources in Korea in 2008, and will roll them out across ten more countries by World Hepatitis Day in May 2009. Raising awareness about breast cancer treatment times in Canada Through our partnership with the Canadian Breast Cancer Network (CBCN), GSK helped raise awareness about unacceptable treatment waiting times and differences in access to breast cancer care across Canada¶s provinces. In 2008, the CBCN published a report that revealed waiting times of up to five years from the initial application by the manufacturer until patients could access a new breast cancer drug. The report provoked extensive national media coverage and a strong call to action for policy makers, politicians, concerned organisations and individuals to work together to address these issues.
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Home Responsibility Public policy and patient advocacy Q&As
Corporate Responsibility Report 2008 Q&As How do you make sure that your lobbying activity doesn¶t contradict or undermine your corporate responsibility work? Corporate responsibility is central to our business. We aim to ensure that all our lobbying activity reflects the values set out in this report as well as being sensitive to the views of our stakeholders. Employees involved in public policy must abide by our Employee Guide to Business Conduct which commits them to acting with honesty and integrity. We have well-established public policy positions. These are developed through wide consultation and are approved by our Corporate Executive Team. Employees who lobby for GSK are closely involved in developing these positions. We believe transparency is key to building trust with our stakeholders and we disclose our public policy positions on our website. Does GSK make political contributions through so-called µ527¶ organisations? Yes, we support a number of µ527¶ organisations such as the New Democratic Network. GSK has no influence over how µ527¶ organisations use GSK contributions; however, our support enables the organisations to develop and advocate policy positions and us to participate in their functions and to debate and discuss important issues for GSK with other organisations, the public and policy makers. Contributions to µ527¶ organisations are not defined as political contributions and so are not subject to our policy to stop all corporate political contributions. Isn¶t your support for patient groups just another marketing tool? No. GSK neither promotes medicines to patient groups nor would ever ask a patient group to endorse a GSK medicine. We work with patient groups in a number of areas, including improving how clinical trials are run, disease awareness initiatives, and on the bigger agenda of ensuring that all new medicines are made available to patients. When GSK provides funding, are you trying to µbuy¶ favours from the patient organisation? No. We never ask for endorsement of any of our medicines or a return on investment for our support. We are careful that our support for an organisation does not compromise its independence and is based on trust and mutual respect, and complies with the highest standards of our code of conduct. How do these groups maintain their independence if they receive significant funding from companies such as GSK? We encourage patient groups to diversify their funding from sources in both the public and the private sector. Patient groups should never become dependent on any one funder from either sector. Our guidelines state that we should provide no more than 25 per cent of a group¶s overall income, except in exceptional
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Home Responsibility Our work with communities
Corporate Responsibility Report 2008 Our work with communities We donate money, time, medicines and equipment to support communities around the world. Our programmes are long term and focus on addressing healthcare challenges and increasing access to medicines. We also invest in improving education, especially science education, and provide some support for art and environment initiatives. We believe contributing some of our profits to benefit communities is part of being a responsible company. Community investment also brings us long-term business benefits by improving our reputation, boosting employee morale and helping us build good relations with governments. We do not use community investment as a way of generating sales. We invest in innovative projects to: prevent disease build the capacity of community organisations promote education, particularly in science We focus our community investment on areas relevant to our business and the skills of our people. This is where we can bring the most benefit to communities and GSK. Most of our investment is made through non-profit organisations that are experts in healthcare and education. These organisations are best placed to understand local community needs and to target resources effectively. Donations are made at a company level and by individual sites.
Healthcare We support major public health initiatives in the developing world. For example: We are a founding member of the Global Alliance to Eliminate Lymphatic Filariasis (GAELF). We have committed to donating as many albendazole tablets as are needed to eliminate lymphatic filariasis (elephantiasis), a disabling parasitic disease that threatens 1.3 billion people ± one-fifth of the world¶s population - in over 80 countries Our Positive Action programme works with communities to reduce stigma and improve capacity for HIV prevention and treatment Our African Malaria Partnership supports Mobilising for Malaria, an advocacy initiative to generate political commitment and funding to combat malaria PHASE ± Personal Hygiene And Sanitation Education ± is our hand-washing programme for children to prevent diarrhoea-related disease and improve school attendance We donate essential antibiotics and other medicines for disaster relief to under-served communities around the world, while specific programmes support low-income, uninsured patients in the US
Education We support education programmes [link to Supporting science education] in the UK and the US to inspire young people about science, improve their understanding of science and encourage them to pursue a science-related career. Our programmes enable young people to make informed decisions about the
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science-related issues they meet in everyday life such as healthy eating, vaccinations and the value of medicines.
Measuring impact We ask our partner organisations for our larger programmes to report annually on the progress of the projects supported by GSK to ensure that the money we give has the greatest possible impact. We review results with our partners and identify any changes required to achieve the programmes¶ objectives.
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Home Responsibility Our work with communities Community investment
Corporate Responsibility Report 2008 Community investment In 2008, our global community investment was 124 million ($229 million) compared with (restated) 109 ($219 million) in 2007, an increase of 13 per cent. Just over half of this comprises product donations and this is the first year we have valued donations using cost (average cost of goods) rather than the wholesale acquisition price (WAC). Our new approach to valuing donations is a more accurate reflection of the true cost to GSK and is therefore more transparent. We believe we are the first pharmaceutical company to adopt this practice. We will continue to also report the WAC value of our donations for benchmarking purposes. We belong to the UK¶s London Benchmarking Group (LBG) and the US Committee Encouraging Corporate Philanthropy (CECP). LBG guidelines report product donations at cost, whereas CECP guidelines report product donations at market value. For comparative purposes the total value of giving in 2008 using WAC for products would be 343 million ($634 million) compared with 282 million ($564 million) in 2007. The giving figure is built up in the following way: Method of giving ( million)
Breakdown of cash giving (%)
Our product donations are made through three main programmes:
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Our Patient Assistance Programmes to support low-income patients in the US, totalling 56 million (at cost) in Humanitarian product donations to under-served communities in 118 countries, including people affected by the natural disasters in Burma and China, totalling 5m (at cost) in 2008 Donation of 266 million albendazole tablets for the lymphatic filariasis (LF) elimination programme. In 2008 we announced we would double our manufacturing capacity for albendazole tablets to 600 million tablets per year by 2010 from the current 300 million, to meet the growth of the LF programme, especially in India. As a result, our donations of albendazole tablets will increase significantly from 2009 onwards We already publish data about our charitable grants made to patient groups in our European, Emerging Markets and Asia Pacific regions. We are further increasing transparency by publishing details of all our charitable grants over 10,000 ($20,000). Find out more about our grants. GSK was one of 21 companies and the only manufacturing company to be awarded the new CommunityMark, following independent assessment, for outstanding community investment. The Mark, created by Business in the Community, is endorsed by the UK government and voluntary sector leaders. It was given for our work at local and national level in the UK as well as for our larger international programmes.
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Home Responsibility Our work with communities Preventing disease
Corporate Responsibility Report 2008 Preventing disease Infectious diseases kill millions of people in the developing world each year. They cause misery, cost billions of dollars and slow economic growth. Preventing infection is more effective than treatment and can have significant social and economic benefits. Our vaccines play a significant role in preventing disease. GSK supports innovative community approaches to disease prevention that are tailored to local settings and needs. 2008 marked two significant milestones in our support for community disease prevention; it is ten years since we made a commitment to eliminate lymphatic filariasis (LF) worldwide and since we launched our hand-washing programme PHASE, to prevent diarrhoea-related disease. We also support a wide range of local programmes to help prevent disease in the communities where we operate.
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Home Responsibility Our work with communities Preventing disease Eliminating lymphatic filariasis
Corporate Responsibility Report 2008 Eliminating lymphatic filariasis (LF) We have committed to donating as many tablets of albendazole, our anti-parasitic drug, as are needed to eliminate LF. LF is a disfiguring disease prevalent in tropical and sub-tropical countries. Transmitted by mosquitoes, it can lead to severe swelling of the arms, legs, breasts and genitals and thickening of the skin. LF is one of the world¶s leading causes of permanent disability, with 1.3 billion people in over 80 countries (approximately one-fifth of the world¶s population) at risk of infection. In 2008, GSK donated 266 million albendazole treatments to 30 countries. This included 130 million tablets to India, the country with the largest LF burden. The economic cost of LF in India is estimated to exceed US$840 million due to treatment costs and reduced working time. Since the programme began we have donated over one billion tablets and over 180 million people have been treated at least once with albendazole. We estimate that to the end of 2007 66 million babies born in the treated regions have been spared the risk of contracting LF. A study published in the journal Public Library of Science on Neglected Tropical Diseases confirmed the progress already made towards eliminating LF. This year we decided to double our annual manufacturing capacity for albendazole tablets to 600 million tablets per year by 2010 by opening of a new production line in Nashik, western India. An additional benefit of the albendazole tablets given for the LF programme is that they also treat intestinal worms. These parasites particularly affect children, causing anaemia and malnutrition, and stunting growth. We estimate that since the beginning of the LF programme, over 170 million albendazole treatments have been administered to children and over 140 million to women of child-bearing age. This will have had a positive impact on the overall health of those infected with intestinal worms. Each country aiming to eliminate LF must treat all at-risk people once a year for at least five years. So far, Egypt, several Pacific Island countries, Sri Lanka and Zanzibar have completed five annual mass drug administrations (MDAs). These countries are monitoring their populations to evaluate the impact of the programme on the disease. Assessments conducted in Egypt and Vanuatu, a Pacific Island nation, showed that LF has been eliminated in most areas of these countries. Programmes in Tanzania, Madagascar and Burkina Faso have also reported an unexpected benefit of the MDAs, beyond reducing infection rates. In these countries, some patients already infected with LF are describing an alleviation of symptoms after the MDAs, including reduced leg swelling and a reduction in frequency and length of acute attacks (spells of feverishness and loss of energy). Acute attacks are the most incapacitating symptom of LF. Read more about our approach to LF and the patients who are living with the disease.
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Home Responsibility Our work with communities Preventing disease Personal Hygiene and Sanitation Education
Corporate Responsibility Report 2008 Personal Hygiene And Sanitation Education (PHASE) Every year more than two million people die of diarrhoea-related disease, mostly children in developing countries. These deaths can often be easily prevented through better hand-washing and sanitation. PHASE is a school-based programme that helps to reduce diarrhoea-related disease by encouraging school children to wash their hands. We established PHASE in 1998 and since then we have invested over 4 million ($7 million) in the programme. PHASE is run in partnership with AMREF, Save the Children and Earth Institute at Columbia University, as well as Ministries of Health and Education in the countries where the programme operates. The programme has had impressive results. In Bangladesh, for example, in partnership with Save the Children, we introduced PHASE to 127 schools in one of the country¶s poorest areas, where it is helping to improve the lives of 20,000 young children and their families. In the three-year period of the programme¶s funding: Schools with hand-washing facilities increased from 5 per cent to 97 per cent, leading to an increase in hand washing with soap by schoolchildren from 40 per cent to 75 per cent More latrines were made available in schools and a further 1,200 latrines constructed in children¶s homes, resulting in a marked decrease in open defecation from 75 per cent of the population to 13 per cent With healthier children, school attendance rates increased from 53 per cent to 80 per cent over the period 2006 to July 2008 The success of PHASE in Nasirnagar (Bangladesh) led to the decision to expand the programme to include all 950 schools in the Brahmanbaria district. Save the Children is now working with health and education ministers to prepare them for the scale-up. In 2008, we committed funding of 320,000 over three years to extend the programme into the slum areas of Mumbai in India with our partner Pratham. PHASE now operates in 13 countries and has reached over 500,000 children. Our aim is for the programme to reach over one million children by next year.
Supporting the Millennium Development Goals In 2000 world leaders agreed the Millennium Development Goals (MDGs) to meet the needs of the world¶s poorest people. The MDGs include targets to halve extreme poverty and hunger by 2015, and improve education, health, gender equality and environmental sustainability. We have introduced PHASE to two Millennium Villages in Malawi and Senegal. Millennium Villages are research projects in African communities designed to find practical ways to meet the MDGs
Global Hand-Washing Day The first Global Hand-Washing Day was held during 2008. This was marked by a week of activities encouraging millions of children and adults around the world to wash their hands, with the aim of improving hygiene and health. PHASE partners arranged a range of activities to promote hand-washing which reached around 300,000 people. Read more about PHASE and the Global Hand-Washing Day.
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Home Responsibility Our work with communities Preventing disease Local programmes
Corporate Responsibility Report 2008 Local programmes We support a wide range of programmes to help prevent disease in the communities where we operate. We fund these programmes at corporate and local levels. Below are just a few local programme examples. Australia - helping Aborigines tackle diabetes Indigenous Australians have poorer heath and a life expectancy of about 20 years less than the rest of the Australian population. This is due to the rapid increase in so-called µlifestyle¶ diseases, including type 2 diabetes, and could wipe out indigenous populations in 20 years. GSK is working with the Unity of First People of Australia in the far north of Western Australia on their Diabetes Management and Care Program. The programme aims to arrest the rising incidence of diabetes in Aboriginal communities by encouraging the local people to take on the responsibility for their community ¶s health, because health providers can only do so much without their active support. UK ± improving sexual health services for disabled people We have donated over 520,000 over three years to Leonard Cheshire Disability to fund a project to give young disabled people better access to sexual health services. The project addresses knowledge and understanding gaps relating to disabled people¶s sexual health issues. Over the three-year period, the organisation will run focus groups and workshops to identify key issues and will develop a range of materials to support sexual health workers who deal with disabled people. UK - promoting sport for children Through our Consumer Healthcare business we support Access Sport, an organisation that encourages young people in the UK to keep fit and participate in sport. In 2008, Access Sport held three µSports Jam¶ events, in Bristol, Bath and London, where more than 3,500 children took part in sporting activities. We provided funding and our employees volunteered their time and held fundraising events. For example, 90 employees raised money by cycling from Land¶s End to John O¶Groats. In future GSK staff will also support Access Sport by volunteering at their local sports clubs during our annual employee volunteering day. Preventing childhood obesity in the US In the US we support the Zone Health initiative which helps schools strengthen their policies and programmes on nutrition and physical activity. It aims to improve the health of more than 200,000 children by 2010. Following a successful pilot, Zone Health is being expanded and GSK has announced support for the FitU programme in the Washington DC area, which will benefit more than 600 young people over three years.
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Home Responsibility Our work with communities Building community capacity
Corporate Responsibility Report 2008 Building community capacity Lack of healthcare infrastructure ± including clinics and trained healthcare professionals ± and cultural attitudes are significant barriers to treatment in many developing countries. Our global programmes such as Positive Action is working with communities affected by HIV and AIDS, and our African Malaria Partnership is improving prevention and access to malaria treatment. We support local initiatives that help overcome stigma, build the capacity of communities to provide healthcare and combat disease. We also provide humanitarian relief in times of emergency and natural disasters.
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Home Responsibility Our work with communities Building community capacity Combating HIV/AIDS ± Positive Action
Corporate Responsibility Report 2008 Combating HIV/AIDS - Positive Action Positive Action works with community organisations to build capacity to counter the ignorance and stigma surrounding HIV through outreach, education and advocacy. Since it was established in 1992, it has provided over $70 million, funding projects in 63 countries across Africa, Asia, Latin America and Eastern Europe. Through Positive Action, GSK has pioneered support for vulnerable communities, including men who have sex with men, intravenous drug users, sex workers, migrants, young people, orphans and vulnerable children and marginilised poor rural women - groups who have limited human rights or public voice and are thus excluded from playing a role in developing mainstream programming. It is essential to work with these groups if we expect to make a difference to this epidemic. During 2008, we supported 18 Positive Action programmes in 21 countries. Key projects include: Fighting stigma and discrimination in Mexico among vulnerable sectors of the population Bringing HIV education to vulnerable women in India through self-help groups Helping communities in Asia understand and prepare for treatment programmes Improving access to treatment in Kenya by promoting greater understanding and involvement of communities Update August 2009
In July 2009 we announced the creation of a new Positive Action for Children Fund. The Fund will make 50 million ($80 million) available over ten years to help prevent mother-to-child transmission of HIV and to support orphans and vulnerable children. Positive Action programmes involve grass roots organisations that are able to continue to support their communities after the projects have come to an end. This year we were the principal sponsor of the Global Village (the community space) at the International AIDS2008 conference held in Mexico City. We also hosted community forums to allow delegates to share experience of their fight against HIV/AIDS. Read more about Positive Action.
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Home Responsibility Our work with communities Building community capacity Combating malaria ± Africa Malaria Partnership
Corporate Responsibility Report 2008 Combating malaria ± Africa Malaria Partnership Every year up to 500 million people are affected by malaria and over one million die from it, mostly young children in Africa. But the disease can be prevented by controlling the breeding of mosquitoes and using lowcost measures such as insecticide-treated nets. Malaria can be cured if treated promptly with effective medicines. We established the African Malaria Partnership in 2001 to improve the prevention and access to treatment of malaria in sub-Saharan Africa. Since then we have invested over $3 million in initiatives to combat the disease. 2008 was the final year of our three-year grant to support Mobilising for Malaria, an advocacy initiative to generate greater awareness, political commitment and sustained funding for malaria in Europe and Africa. National Coalitions Against Malaria have now been launched in the UK, Belgium, France, Ethiopia and Cameroon bringing together advocates and activists from the public sector, NGOs, the media, the private sector and the political, academic and scientific communities. Part of this initiative was the award of innovation grants to civil society organisations in Africa to boost advocacy efforts and inspire African civil society organisations and media to become leaders in the fight against malaria in their own countries. Grants were awarded to civil organisations in Nigeria, Tanzania, Ghana, Mozambique, Democratic Republic of Congo and Burkina Faso. We supported a journalist competition run by the Guardian, a British newspaper, to raise awareness of issues faced by people with malaria and LF. Their global web site attracted 20,000 unique visitors and the winning stories were published in two dedicated supplements. Read more about our malaria programmes.
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Home Responsibility Our work with communities Building community capacity Local programmes
Corporate Responsibility Report 2008 Local programmes We support a wide range of programmes to build healthcare capacity in the communities where we operate. We fund these programmes at corporate and local levels. Below are just a few local programme examples.
Training midwives in Vietnam We support a project to train birth attendants to bring maternal healthcare services to rural villages in Vietnam. The project aims to reduce childbirth complications and decrease newborn fatality from the unacceptably high level of 6 per cent. The trainees are housed in a residential training centre built by GSK at Tu Du Hospital, Ho Chi Minh City. Supported by hospital staff, they spend four months gaining practical knowledge of maternal and child healthcare. During the first phase of the project, between 2004 and 2007, over 520 midwives ± representing 38 of Vietnam¶s 54 ethnic groups ± have graduated with a government-recognised qualification. The midwives return to their villages equipped with a medical pack. Some are also provided with a motor scooter to assist access to remote areas. Phase two of the project was launched in 2008. This involves hospital staff visiting villages to provide additional training to the midwives and to provide basic pregnancy and reproductive health education for community members.
Palliative care for children in Romania Over the last three years we have been working in partnership with the Hospice Casa Sperentei in Romania on the µBeacon of Hope¶ project to improve the level of care available to terminally ill children in the Balkans. Huge progress has been achieved, helping to change attitudes towards dying patients in the region. The project has received acclaim from the Romanian government, which began a partnership with the hospice in 2007 with a view to creating a national plan for palliative care. Key achievements include the establishment of a children¶s palliative care unit in Brasov, a mobile nursing team and a network of care SURYLGHUVDFURVVWKHUHJLRQ7KH project has developed a regional centre of excellence for the whole of south-eastern Europe that provides palliative care training for health workers and volunteers. As a result, children¶s palliative care services have been set up in neighbouring Moldova.
New fund for Children¶s Hospital of Philadelphia In October 2008 we announced a $1 million donation to the Children¶s Hospital of Philadelphia to help young people with cancer in the US. The hospital runs one of the world¶s largest paediatric cancer programmes. Our contribution, together with a matched donation from the hospital, will form the GlaxoSmithKline Hope for Families Fund. The Fund is a permanent endowment to enable children and young adults suffering from relapsed and hard-to-cure cancers access to innovative therapies. It will help cover the travel and accommodation costs of patients and their families, who often must stay at or near the hospital for extended periods.
Healthcare for the homeless in Pittsburgh GSK supports Pittsburgh Mercy Foundation¶s Operation Safety Net µStreet Medicine¶ outreach programme that enables Pittsburgh¶s homeless to access free healthcare. The programme includes a mobile medical unit, a drop-in clinic and teams of clinicians and care workers who walk the streets offering medical examinations and treatment to homeless people.
Rewarding community healthcare organisation in the UK
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Each year the GSK IMPACT Awards recognise voluntary organisations that have significantly improved the health of their local communities. Ten winning charities receive 25,000 each and the overall winner is awarded an extra 10,000. In 2008 the UK Impact Awards programme introduced an initiative for the managers of the winning organisations to be trained in leadership, networking and fundraising skills. This will help strengthen small charities that are often unable to afford this vital skills training. The GSK IMPACT Awards also run in Philadelphia in the US. Read more about the GSK IMPACT Awards and the winning organisations.
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Home Responsibility Our work with communities Building community capacity Responding to disasters around the world
Corporate Responsibility Report 2008 Responding to disasters around the world GSK provides humanitarian assistance in the form of cash and product donations in times of emergency and natural disasters. In 2008, as part of our ongoing programme, we provided humanitarian relief to many areas, including China, Burma and Zimbabwe. Following the cyclone in Burma we worked with AmeriCares, one of our partners specialising in rapidresponse delivery, to supply GSK-donated medicines. We also made a donation of 50,000 ($93,000) to Save the Children, a charity that has an established presence in Burma. Our contribution supported recovery efforts, including the provision of shelter, child protection, food and nutrition and emergency health services for over 100,000 children and their families. The earthquake which hit Sichuan Province in China in May left over 70,000 dead and 15 million people displaced or homeless. GSK Hong Kong/China gave a cash donation of 10 million Yuan, approximately $1.4 million, to the China Red Cross, and donated supplies of basic medicines. We provided funds to the British Red Cross for a Mass Sanitation Module to provide emergency sanitation facilities and hygiene education for up to 20,000 people during times of crisis. This helps to avoid outbreaks of disease and was deployed in December 2008 in Zimbabwe to help stem the cholera outbreak. We continued our support for communities affected by the 2004 Indian Ocean tsunami, which caused huge damage to coastal areas across South Asia: In Sri Lanka, we are helping to establish mobile clinics that increase access to quality healthcare for isolated communities affected by the tsunami and conflict in the country. In 2008, 47 mobile clinics were set up in 13 different locations, providing the only reliable healthcare services in these areas. The clinics treated nearly 10,500 patients and in total gave healthcare education messages to 12,000 patients and the people accompanying them We are working with Leonard Cheshire Disability to create an inclusive, barrier-free and rights-based society for people with disabilities who were affected by the 2004 tsunami in Galle, Sri Lanka. A new resource centre will be established to support people with disabilities by providing rehabilitation services, mainstream education and livelihood opportunities. We support long-term relief efforts in affected areas of Chennai, India, by providing nursing training to young women from poor villages. As well boosting healthcare services in the area, the training enables the women to support themselves financially by becoming nursing assistants. Between 2007 and 2009 420 women will be trained. In Thailand we are helping to boost the economies of six coastal villages where the local fishing industry was destroyed by the tsunami. With the Raks Thai Foundation we support initiatives that provide business loans and organise youth activities and efforts to improve the local environment. We also gave funding to help NGO Francois Xavier Bagnoud (FXB) to introduce the concept of a µmodel village¶. This is a low-cost, sustainable, community-based programme that has been successful in helping families to achieve selfsufficiency
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Home Responsibility Our work with communities Supporting science education
Corporate Responsibility Report 2008 Supporting science education In the UK and US, the numbers of young people choosing science subjects is falling and many students lack proficiency in either reading or mathematics. As a result, both countries face a significant skills shortage. The success of our business relies on us being able to recruit talented individuals, particularly those with science qualifications. We also want young people to make sound decisions about the science-related issues they meet in everyday life. Our education programmes help make science more relevant to young people in the UK and US, stimulating their interest in science, and supports the training and development of science teachers.
UK Project ENTHUSE Half of secondary school science teachers in the UK have had no subject training within the past five years. Project ENTHUSE was launched in 2008 to improve continuing professional development of science teachers and to provide them with the latest techniques to rekindle interest in science. Teachers, assistants and technicians can apply for an ENTHUSE Award to help them study at the National Science Learning Centre at the University of York. The award will cover course fees, the cost of covering teachers¶ roles while they are on the course, and travel and accommodation for 2,200 teachers each year. The schools will also receive a small amount of money to help implement ideas back in the classroom. We have committed 1 million to this initiative helping to create a 30 million fund with support from the UK government, the Wellcome Trust and eight other industry partners. CREST Star Investigators After-school clubs help broaden the interests and experiences of young people, but these often focus on sports or arts rather than science. CREST Star Investigators, developed by the British Association for the Advancement of Science and funded by GSK, aims to redress this balance and engage 5 to 12 year olds in science-based activities. The UK-wide programme offers activity packs to schools and other organisations such as the Brownies and Cubs for use in after-school clubs. The activities encourage children to solve scientific problems through exciting practical investigations. The pack contains activities at three different difficulty levels, and children are awarded a certificate when they complete each stage. So far almost 3,000 packs have been distributed to nearly 1,500 schools. By 2010, we aim to have 5,000 schools and 55,000 children taking part.
US Institute for a Competitive Workforce (ICW) Building on GSK¶s leadership at state and local levels related to reform and improvement of public schools, GSK led the effort to create the ICW on a national level. The result has been a national movement for business/education partnerships focused on improved academic achievement in our public school system in order to help ensure a qualified workforce for American businesses in the future. Science in the Summer We support Science in the Summer, a free education programme designed to get young people in
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Pittsburgh, Pennsylvania, Greater Philadelphia and North Carolina interested in science. Classes held in local libraries give children the chance to take part in hands-on experiments and take courses ranging from genetics to oceanography. The programme began in 1986, and in 2008 GSK invested $575,000 across 162 sites where over 6,000 children participated in the programme. North Carolina New Schools Project GSK partners with the North Carolina New Schools Project, an initiative that aims to transform teaching and learning so that high school students graduate ready for college and the workplace. GSK is helping to fund the development of science and technology programmes at ten of North Carolina¶s low-performing high schools. The initiative aims to improve the schools¶ test results and graduation rates. GSK also funds a review of state curricula so that the benefits are shared more widely.
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Home Responsibility Our work with communities Our plans
Corporate Responsibility Report 2008 Our plans Volunteering From 2009, we will expand our volunteering programme so that every GSK employee can spend at least one day a year helping in their community. Employees will select local organisations to support and will undertake a variety of work for them, ranging from manual jobs to fund-raising. This will include supporting employees that wish to visit schools to encourage science education. We will also be launching an international assignment programme to enable a select number of employees to use their professional skills to support our non-profit partners for extended periods.
Positive Action We have agreed to extend three of our larger HIV programmes (Zingatia Maisha in Kenya, Vida Digna in Mexico and Reach India) for an additional year to ensure their sustainability. We will be working with the Ubuntu Education Fund in South Africa to expand a programme called µLiving Positively¶. This programme will work with men and older boys in Port Elizabeth township to challenge gender roles that exacerbate HIV infection and exclude men from HIV services. We will be working with AIDS Action Europe to provide networking for HIV/AIDS NGOs across Eastern Europe and Central Asia for improved HIV policy, advocacy and programming and support for those facing the HIV crisis. We will be working with the American Foundation for AIDS Research (amfAR) to expand its initiative to provide prevention, care and support services for men who have sex with men in Asia Pacific. We will also work with AIDS patient groups in the Philippines to increase members understanding of health issues.
PHASE Our partner Pratham will be implementing the PHASE programme in the slum areas of Mumbai, India. We will also extend PHASE to new districts in Uganda and advocate for the incorporation of PHASE into national policy, enabling sustainability and replication of the project nationwide.
LF We are increasing our manufacturing capacity for albendazole tablets to 600 million tablets per year by 2010. This will enable us to increase fourfold the number of tablets we donated in 2007.
US We are continuing to provide leadership and support to the Children¶s Health Fund (CHF) Referral Management Initiative to increase access to specialist healthcare for homeless and uninsured American families. We are also supporting a pilot telemedicine project to help patients access specialist care. CHF¶s new Memphis Regional Children¶s Health Project will serve as the pilot site to link approximately 400 rural patients with specialists at Memphis hospital, using state-of-the-art videoconferencing technology.
Europe, Emerging Markets and Asia Pacific regions Several new programmes are being implemented. For example In Greece we are helping to introduce the concept of home-based nursing services for children living with cancer
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In the Netherlands, we are supporting a national programme to promote healthy behaviours among young people, helping them to make informed decisions about what they eat and to encourage regular physical activity We will also seek new partnerships to improve community healthcare through social venture and enterprise projects Preparing for when the funding stops
Most of our programmes run over a number of years, recognising that it takes time to build change. But from the start we plan for what will happen at the end of our funding. We work hard with community organisations to bring results over the life of a project (usually around three years) and to help organisations win funding from other sources to continue their work. From the start we require our partners to work to a budget to make sure funding is spent effectively and produces the right results. We also ask our partners to demonstrate achievements by producing an annual progress report. These reports show evidence of success and are a crucial part of attracting new donors.
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Appendix B: President Obama Healthcare Speech
Remarks by the President to a Joint Session of Congress on Health Care | ...
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THE WHITE HOUSE Office of the Press Secretary _________________________________________________________________________ For Immediate Release September 9, 2009 REMARKS BY THE PRESIDENT TO A JOINT SESSION OF CONGRESS ON HEALTH CARE U.S. Capitol Washington, D.C.
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8:16 P.M. EDT
THE PRESIDENT: Madam Speaker, Vice President Biden, members of Congress, and the American people: When I spoke here last winter, this nation was facing the worst economic crisis since the Great Depression. We were losing an average of 700,000 jobs per month. Credit was frozen. And our financial system was on the verge of collapse. As any American who is still looking for work or a way to pay their bills will tell you, we are by no means out of the woods. A full and vibrant recovery is still many months away. And I will not let up until those Americans who seek jobs can find them -- (applause) -- until those businesses that seek capital and credit can thrive; until all responsible homeowners can stay in their homes. That is our ultimate goal. But thanks to the bold and decisive action we've taken since January, I can stand here with confidence and say that we have pulled this economy back from the brink. (Applause.) I want to thank the members of this body for your efforts and your support in these last several months, and especially those who've taken the difficult votes that have put us on a path to recovery. I also want to thank the American people for their patience and resolve during this trying time for our nation. But we did not come here just to clean up crises. We came here to build a future. (Applause.) So tonight, I return to speak to all of you about an issue that is central to that future -- and that is the issue of health care. I am not the first President to take up this cause, but I am determined to be the last. (Applause.) It has now been nearly a century since Theodore Roosevelt first called for health care reform. And ever since, nearly every President and Congress, whether Democrat or Republican, has attempted to meet this challenge in some way. A bill for comprehensive health reform was first introduced by John Dingell Sr. in 1943. Sixty-five years later, his son continues to introduce that same bill at the beginning of each session. (Applause.) Our collective failure to meet this challenge -- year after year, decade after decade -- has led us to the breaking point. Everyone understands the extraordinary hardships that are placed on the uninsured, who live every day just one accident or illness away from bankruptcy. These are not primarily people on welfare. These are middle-class Americans. Some can't get insurance on the job. Others are self-employed, and can't afford it, since buying insurance on your own costs you three times as much as the coverage you get from your employer. Many other Americans who are willing and able to pay are still denied insurance due to previous illnesses or conditions that insurance companies decide are too risky or too expensive to cover. We are the only democracy -- the only advanced democracy on Earth -- the only wealthy nation -- that allows such hardship for millions of its people. There are now more than 30 million American citizens who cannot get coverage. In just a two-year period, one in every three Americans goes without health care coverage at some point. And every day, 14,000 Americans lose their coverage. In other words, it can happen to anyone. But the problem that plagues the health care system is not just a problem for the uninsured. Those who do have insurance have never had less security and stability than they do today. More and more Americans worry that if you move, lose your job, or change your job, you'll lose your health insurance too. More and more Americans pay their premiums, only to discover that their insurance company has dropped their coverage when they get sick, or won't pay the full cost of care. It happens every day.
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One man from Illinois lost his coverage in the middle of chemotherapy because his insurer found that he hadn't reported gallstones that he didn't even know about. They delayed his treatment, and he died because of it. Another woman from Texas was about to get a double mastectomy when her insurance company canceled her policy because she forgot to declare a case of acne. By the time she had her insurance reinstated, her breast cancer had more than doubled in size. That is heart-breaking, it is wrong, and no one should be treated that way in the United States of America. (Applause.) Then there's the problem of rising cost. We spend one and a half times more per person on health care than any other country, but we aren't any healthier for it. This is one of the reasons that insurance premiums have gone up three times faster than wages. It's why so many employers -- especially small businesses -- are forcing their employees to pay more for insurance, or are dropping their coverage entirely. It's why so many aspiring entrepreneurs cannot afford to open a business in the first place, and why American businesses that compete internationally -- like our automakers -- are at a huge disadvantage. And it's why those of us with health insurance are also paying a hidden and growing tax for those without it -- about $1,000 per year that pays for somebody else's emergency room and charitable care. Finally, our health care system is placing an unsustainable burden on taxpayers. When health care costs grow at the rate they have, it puts greater pressure on programs like Medicare and Medicaid. If we do nothing to slow these skyrocketing costs, we will eventually be spending more on Medicare and Medicaid than every other government program combined. Put simply, our health care problem is our deficit problem. Nothing else even comes close. Nothing else. (Applause.) Now, these are the facts. Nobody disputes them. We know we must reform this system. The question is how. There are those on the left who believe that the only way to fix the system is through a single-payer system like Canada's -- (applause) -- where we would severely restrict the private insurance market and have the government provide coverage for everybody. On the right, there are those who argue that we should end employer-based systems and leave individuals to buy health insurance on their own. I've said -- I have to say that there are arguments to be made for both these approaches. But either one would represent a radical shift that would disrupt the health care most people currently have. Since health care represents one-sixth of our economy, I believe it makes more sense to build on what works and fix what doesn't, rather than try to build an entirely new system from scratch. (Applause.) And that is precisely what those of you in Congress have tried to do over the past several months. During that time, we've seen Washington at its best and at its worst. We've seen many in this chamber work tirelessly for the better part of this year to offer thoughtful ideas about how to achieve reform. Of the five committees asked to develop bills, four have completed their work, and the Senate Finance Committee announced today that it will move forward next week. That has never happened before. Our overall efforts have been supported by an unprecedented coalition of doctors and nurses; hospitals, seniors' groups, and even drug companies -- many of whom opposed reform in the past. And there is agreement in this chamber on about 80 percent of what needs to be done, putting us closer to the goal of reform than we have ever been. But what we've also seen in these last months is the same partisan spectacle that only hardens the disdain many Americans have towards their own government. Instead of honest debate, we've seen scare tactics. Some have dug into unyielding ideological camps that offer no hope of compromise. Too many have used this as an opportunity to score short-term political points, even if it robs the country of our opportunity to solve a long-term challenge. And out of this blizzard of charges and counter-charges, confusion has reigned. Well, the time for bickering is over. The time for games has passed. (Applause.) Now is the season for action. Now is when we must bring the best ideas of both parties together, and show the American people that we can still do what we were sent here to do. Now is the time to deliver on health care. Now is the time to deliver on health care. The plan I'm announcing tonight would meet three basic goals. It will provide more security and stability to those who have health insurance. It will provide insurance for those who don't. And it will slow the growth of health care costs for our families, our businesses, and our government. (Applause.) It's a plan that asks everyone to take responsibility for meeting this challenge -- not just government, not just insurance companies, but everybody including employers and individuals. And it's a plan that incorporates ideas from senators and congressmen, from Democrats and Republicans -- and yes, from some of my opponents in both the primary and general election. Here are the details that every American needs to know about this plan. First, if you are among the hundreds of millions of Americans who already have health insurance through your job, or Medicare, or Medicaid, or the VA, nothing in this plan will require you or your employer to change the coverage or the doctor you have. (Applause.) Let me repeat this: Nothing in our plan requires you to change what you have. What this plan will do is make the insurance you have work better for you. Under this plan, it will be against the law for insurance companies to deny you coverage because of a preexisting condition. (Applause.) As soon as I sign this bill, it will be against the law for insurance companies to drop your coverage when you get sick or water it down when you need it the most. (Applause.) They will no longer be able to place some arbitrary cap on the amount of
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coverage you can receive in a given year or in a lifetime. (Applause.) We will place a limit on how much you can be charged for out-of-pocket expenses, because in the United States of America, no one should go broke because they get sick. (Applause.) And insurance companies will be required to cover, with no extra charge, routine checkups and preventive care, like mammograms and colonoscopies -- (applause) -- because there's no reason we shouldn't be catching diseases like breast cancer and colon cancer before they get worse. That makes sense, it saves money, and it saves lives. (Applause.) Now, that's what Americans who have health insurance can expect from this plan -- more security and more stability. Now, if you're one of the tens of millions of Americans who don't currently have health insurance, the second part of this plan will finally offer you quality, affordable choices. (Applause.) If you lose your job or you change your job, you'll be able to get coverage. If you strike out on your own and start a small business, you'll be able to get coverage. We'll do this by creating a new insurance exchange -- a marketplace where individuals and small businesses will be able to shop for health insurance at competitive prices. Insurance companies will have an incentive to participate in this exchange because it lets them compete for millions of new customers. As one big group, these customers will have greater leverage to bargain with the insurance companies for better prices and quality coverage. This is how large companies and government employees get affordable insurance. It's how everyone in this Congress gets affordable insurance. And it's time to give every American the same opportunity that we give ourselves. (Applause.) Now, for those individuals and small businesses who still can't afford the lower-priced insurance available in the exchange, we'll provide tax credits, the size of which will be based on your need. And all insurance companies that want access to this new marketplace will have to abide by the consumer protections I already mentioned. This exchange will take effect in four years, which will give us time to do it right. In the meantime, for those Americans who can't get insurance today because they have preexisting medical conditions, we will immediately offer low-cost coverage that will protect you against financial ruin if you become seriously ill. (Applause.) This was a good idea when Senator John McCain proposed it in the campaign, it's a good idea now, and we should all embrace it. (Applause.) Now, even if we provide these affordable options, there may be those -- especially the young and the healthy -- who still want to take the risk and go without coverage. There may still be companies that refuse to do right by their workers by giving them coverage. The problem is, such irresponsible behavior costs all the rest of us money. If there are affordable options and people still don't sign up for health insurance, it means we pay for these people's expensive emergency room visits. If some businesses don't provide workers health care, it forces the rest of us to pick up the tab when their workers get sick, and gives those businesses an unfair advantage over their competitors. And unless everybody does their part, many of the insurance reforms we seek -- especially requiring insurance companies to cover preexisting conditions -- just can't be achieved. And that's why under my plan, individuals will be required to carry basic health insurance -- just as most states require you to carry auto insurance. (Applause.) Likewise -- likewise, businesses will be required to either offer their workers health care, or chip in to help cover the cost of their workers. There will be a hardship waiver for those individuals who still can't afford coverage, and 95 percent of all small businesses, because of their size and narrow profit margin, would be exempt from these requirements. (Applause.) But we can't have large businesses and individuals who can afford coverage game the system by avoiding responsibility to themselves or their employees. Improving our health care system only works if everybody does their part. And while there remain some significant details to be ironed out, I believe -- (laughter) -- I believe a broad consensus exists for the aspects of the plan I just outlined: consumer protections for those with insurance, an exchange that allows individuals and small businesses to purchase affordable coverage, and a requirement that people who can afford insurance get insurance. And I have no doubt that these reforms would greatly benefit Americans from all walks of life, as well as the economy as a whole. Still, given all the misinformation that's been spread over the past few months, I realize -(applause) -- I realize that many Americans have grown nervous about reform. So tonight I want to address some of the key controversies that are still out there. Some of people's concerns have grown out of bogus claims spread by those whose only agenda is to kill reform at any cost. The best example is the claim made not just by radio and cable talk show hosts, but by prominent politicians, that we plan to set up panels of bureaucrats with the power to kill off senior citizens. Now, such a charge would be laughable if it weren't so cynical and irresponsible. It is a lie, plain and simple. (Applause.) There are also those who claim that our reform efforts would insure illegal immigrants. This, too, is false. The reforms -- the reforms I'm proposing would not apply to those who are here illegally. AUDIENCE MEMBER: You lie! (Boos.) THE PRESIDENT: It's not true. And one more misunderstanding I want to clear up -- under our plan, no federal dollars will be used to fund abortions, and federal conscience laws will remain in place. (Applause.) Now, my health care proposal has also been attacked by some who oppose reform as a "government takeover" of
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the entire health care system. As proof, critics point to a provision in our plan that allows the uninsured and small businesses to choose a publicly sponsored insurance option, administered by the government just like Medicaid or Medicare. (Applause.) So let me set the record straight here. My guiding principle is, and always has been, that consumers do better when there is choice and competition. That's how the market works. (Applause.) Unfortunately, in 34 states, 75 percent of the insurance market is controlled by five or fewer companies. In Alabama, almost 90 percent is controlled by just one company. And without competition, the price of insurance goes up and quality goes down. And it makes it easier for insurance companies to treat their customers badly -- by cherry-picking the healthiest individuals and trying to drop the sickest, by overcharging small businesses who have no leverage, and by jacking up rates. Insurance executives don't do this because they're bad people; they do it because it's profitable. As one former insurance executive testified before Congress, insurance companies are not only encouraged to find reasons to drop the seriously ill, they are rewarded for it. All of this is in service of meeting what this former executive called "Wall Street's relentless profit expectations." Now, I have no interest in putting insurance companies out of business. They provide a legitimate service, and employ a lot of our friends and neighbors. I just want to hold them accountable. (Applause.) And the insurance reforms that I've already mentioned would do just that. But an additional step we can take to keep insurance companies honest is by making a not-for-profit public option available in the insurance exchange. (Applause.) Now, let me be clear. Let me be clear. It would only be an option for those who don't have insurance. No one would be forced to choose it, and it would not impact those of you who already have insurance. In fact, based on Congressional Budget Office estimates, we believe that less than 5 percent of Americans would sign up. Despite all this, the insurance companies and their allies don't like this idea. They argue that these private companies can't fairly compete with the government. And they'd be right if taxpayers were subsidizing this public insurance option. But they won't be. I've insisted that like any private insurance company, the public insurance option would have to be self-sufficient and rely on the premiums it collects. But by avoiding some of the overhead that gets eaten up at private companies by profits and excessive administrative costs and executive salaries, it could provide a good deal for consumers, and would also keep pressure on private insurers to keep their policies affordable and treat their customers better, the same way public colleges and universities provide additional choice and competition to students without in any way inhibiting a vibrant system of private colleges and universities. (Applause.) Now, it is -- it's worth noting that a strong majority of Americans still favor a public insurance option of the sort I've proposed tonight. But its impact shouldn't be exaggerated -- by the left or the right or the media. It is only one part of my plan, and shouldn't be used as a handy excuse for the usual Washington ideological battles. To my progressive friends, I would remind you that for decades, the driving idea behind reform has been to end insurance company abuses and make coverage available for those without it. (Applause.) The public option -- the public option is only a means to that end -- and we should remain open to other ideas that accomplish our ultimate goal. And to my Republican friends, I say that rather than making wild claims about a government takeover of health care, we should work together to address any legitimate concerns you may have. (Applause.) For example -- for example, some have suggested that the public option go into effect only in those markets where insurance companies are not providing affordable policies. Others have proposed a co-op or another non-profit entity to administer the plan. These are all constructive ideas worth exploring. But I will not back down on the basic principle that if Americans can't find affordable coverage, we will provide you with a choice. (Applause.) And I will make sure that no government bureaucrat or insurance company bureaucrat gets between you and the care that you need. (Applause.) Finally, let me discuss an issue that is a great concern to me, to members of this chamber, and to the public -- and that's how we pay for this plan. And here's what you need to know. First, I will not sign a plan that adds one dime to our deficits -- either now or in the future. (Applause.) I will not sign it if it adds one dime to the deficit, now or in the future, period. And to prove that I'm serious, there will be a provision in this plan that requires us to come forward with more spending cuts if the savings we promised don't materialize. (Applause.) Now, part of the reason I faced a trillion-dollar deficit when I walked in the door of the White House is because too many initiatives over the last decade were not paid for -- from the Iraq war to tax breaks for the wealthy. (Applause.) I will not make that same mistake with health care. Second, we've estimated that most of this plan can be paid for by finding savings within the existing health care system, a system that is currently full of waste and abuse. Right now, too much of the hard-earned savings and tax dollars we spend on health care don't make us any healthier. That's not my judgment -- it's the judgment of medical professionals across this country. And this is also true when it comes to Medicare and Medicaid. In fact, I want to speak directly to seniors for a moment, because Medicare is another issue that's been subjected to demagoguery and distortion during the course of this debate. More than four decades ago, this nation stood up for the principle that after a lifetime of hard work, our seniors should not be left to struggle with a pile of medical bills in their later years. That's how Medicare was born. And it remains a sacred trust that must be passed down from one generation to the next. (Applause.) And that is why not
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Remarks by the President to a Joint Session of Congress on Health Care | ...
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a dollar of the Medicare trust fund will be used to pay for this plan. (Applause.) The only thing this plan would eliminate is the hundreds of billions of dollars in waste and fraud, as well as unwarranted subsidies in Medicare that go to insurance companies -- subsidies that do everything to pad their profits but don't improve the care of seniors. And we will also create an independent commission of doctors and medical experts charged with identifying more waste in the years ahead. (Applause.) Now, these steps will ensure that you -- America's seniors -- get the benefits you've been promised. They will ensure that Medicare is there for future generations. And we can use some of the savings to fill the gap in coverage that forces too many seniors to pay thousands of dollars a year out of their own pockets for prescription drugs. (Applause.) That's what this plan will do for you. So don't pay attention to those scary stories about how your benefits will be cut, especially since some of the same folks who are spreading these tall tales have fought against Medicare in the past and just this year supported a budget that would essentially have turned Medicare into a privatized voucher program. That will not happen on my watch. I will protect Medicare. (Applause.)
Now, because Medicare is such a big part of the health care system, making the program more efficient can help usher in changes in the way we deliver health care that can reduce costs for everybody. We have long known that some places -- like the Intermountain Healthcare in Utah or the Geisinger Health System in rural Pennsylvania -offer high-quality care at costs below average. So the commission can help encourage the adoption of these common-sense best practices by doctors and medical professionals throughout the system -- everything from reducing hospital infection rates to encouraging better coordination between teams of doctors. Reducing the waste and inefficiency in Medicare and Medicaid will pay for most of this plan. (Applause.) Now, much of the rest would be paid for with revenues from the very same drug and insurance companies that stand to benefit from tens of millions of new customers. And this reform will charge insurance companies a fee for their most expensive policies, which will encourage them to provide greater value for the money -- an idea which has the support of Democratic and Republican experts. And according to these same experts, this modest change could help hold down the cost of health care for all of us in the long run. Now, finally, many in this chamber -- particularly on the Republican side of the aisle -- have long insisted that reforming our medical malpractice laws can help bring down the cost of health care. (Applause.) Now -- there you go. There you go. Now, I don't believe malpractice reform is a silver bullet, but I've talked to enough doctors to know that defensive medicine may be contributing to unnecessary costs. (Applause.) So I'm proposing that we move forward on a range of ideas about how to put patient safety first and let doctors focus on practicing medicine. (Applause.) I know that the Bush administration considered authorizing demonstration projects in individual states to test these ideas. I think it's a good idea, and I'm directing my Secretary of Health and Human Services to move forward on this initiative today. (Applause.) Now, add it all up, and the plan I'm proposing will cost around $900 billion over 10 years -- less than we have spent on the Iraq and Afghanistan wars, and less than the tax cuts for the wealthiest few Americans that Congress passed at the beginning of the previous administration. (Applause.) Now, most of these costs will be paid for with money already being spent -- but spent badly -- in the existing health care system. The plan will not add to our deficit. The middle class will realize greater security, not higher taxes. And if we are able to slow the growth of health care costs by just one-tenth of 1 percent each year -- one-tenth of 1 percent -- it will actually reduce the deficit by $4 trillion over the long term. Now, this is the plan I'm proposing. It's a plan that incorporates ideas from many of the people in this room tonight -Democrats and Republicans. And I will continue to seek common ground in the weeks ahead. If you come to me with a serious set of proposals, I will be there to listen. My door is always open. But know this: I will not waste time with those who have made the calculation that it's better politics to kill this plan than to improve it. (Applause.) I won't stand by while the special interests use the same old tactics to keep things exactly the way they are. If you misrepresent what's in this plan, we will call you out. (Applause.) And I will not -and I will not accept the status quo as a solution. Not this time. Not now. Everyone in this room knows what will happen if we do nothing. Our deficit will grow. More families will go bankrupt. More businesses will close. More Americans will lose their coverage when they are sick and need it the most. And more will die as a result. We know these things to be true. That is why we cannot fail. Because there are too many Americans counting on us to succeed -- the ones who suffer silently, and the ones who shared their stories with us at town halls, in e-mails, and in letters. I received one of those letters a few days ago. It was from our beloved friend and colleague, Ted Kennedy. He had written it back in May, shortly after he was told that his illness was terminal. He asked that it be delivered upon his death. In it, he spoke about what a happy time his last months were, thanks to the love and support of family and friends, his wife, Vicki, his amazing children, who are all here tonight. And he expressed confidence that this would be the year that health care reform -- "that great unfinished business of our society," he called it -- would finally pass. He
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Appendix B: President Obama Healthcare Speech (cont.)
Remarks by the President to a Joint Session of Congress on Health Care | ...
http://www.whitehouse.gov/the_press_office/remarks-by-the-president-to...
repeated the truth that health care is decisive for our future prosperity, but he also reminded me that "it concerns more than material things." "What we face," he wrote, "is above all a moral issue; at stake are not just the details of policy, but fundamental principles of social justice and the character of our country." I've thought about that phrase quite a bit in recent days -- the character of our country. One of the unique and wonderful things about America has always been our self-reliance, our rugged individualism, our fierce defense of freedom and our healthy skepticism of government. And figuring out the appropriate size and role of government has always been a source of rigorous and, yes, sometimes angry debate. That's our history.
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For some of Ted Kennedy's critics, his brand of liberalism represented an affront to American liberty. In their minds, his passion for universal health care was nothing more than a passion for big government.
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On issues like these, Ted Kennedy's passion was born not of some rigid ideology, but of his own experience. It was the experience of having two children stricken with cancer. He never forgot the sheer terror and helplessness that any parent feels when a child is badly sick. And he was able to imagine what it must be like for those without
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But those of us who knew Teddy and worked with him here -- people of both parties -- know that what drove him was something more. His friend Orrin Hatch -- he knows that. They worked together to provide children with health insurance. His friend John McCain knows that. They worked together on a Patient's Bill of Rights. His friend Chuck Grassley knows that. They worked together to provide health care to children with disabilities.
That large-heartedness -- that concern and regard for the plight of others -- is not a partisan feeling. It's not a Republican or a Democratic feeling. It, too, is part of the American character -- our ability to stand in other people's shoes; a recognition that we are all in this together, and when fortune turns against one of us, others are there to lend a helping hand; a belief that in this country, hard work and responsibility should be rewarded by some measure of security and fair play; and an acknowledgment that sometimes government has to step in to help deliver on that promise.
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This has always been the history of our progress. In 1935, when over half of our seniors could not support themselves and millions had seen their savings wiped away, there were those who argued that Social Security would lead to socialism, but the men and women of Congress stood fast, and we are all the better for it. In 1965, when some argued that Medicare represented a government takeover of health care, members of Congress -Democrats and Republicans -- did not back down. They joined together so that all of us could enter our golden years with some basic peace of mind.
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Our Gov ernm ent You see, our predecessors understood that government could not, and should not, solve every problem. They understood that there are instances when the gains in security from government action are not worth the added constraints on our freedom. But they also understood that the danger of too much government is matched by the perils of too little; that without the leavening hand of wise policy, markets can crash, monopolies can stifle competition, the vulnerable can be exploited. And they knew that when any government measure, no matter how carefully crafted or beneficial, is subject to scorn; when any efforts to help people in need are attacked as un-American; when facts and reason are thrown overboard and only timidity passes for wisdom, and we can no longer even engage in a civil conversation with each other over the things that truly matter -- that at that point we don't merely lose our capacity to solve big challenges. We lose something essential about ourselves.
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That was true then. It remains true today. I understand how difficult this health care debate has been. I know that many in this country are deeply skeptical that government is looking out for them. I understand that the politically safe move would be to kick the can further down the road -- to defer reform one more year, or one more election, or one more term. But that is not what the moment calls for. That's not what we came here to do. We did not come to fear the future. We came here to shape it. I still believe we can act even when it's hard. (Applause.) I still believe -- I still believe that we can act when it's hard. I still believe we can replace acrimony with civility, and gridlock with progress. I still believe we can do great things, and that here and now we will meet history's test. Because that's who we are. That is our calling. That is our character. Thank you, God bless you, and may God bless the United States of America. (Applause.) END
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Appendix C: Every Human Has Rights Declaration
United Nations' Universal Declaration of Human Rights, est. December 10, 1948 OnDecember10th,1948,thenewlyformedUnitedNationsadoptedauniversaldeclarationthattranscended culturalandnationalboundaries.TheUniversalDeclarationofHumanRightsestablishedacommonstandardfor humanachievementforallpeoplesandallnations;rootedinthevaluesoffreedom,equality,solidarity,tolerance, respectandsharedresponsibility. UniversalDeclarationofHumanRights Preamble Whereasrecognitionoftheinherentdignityandoftheequalandinalienablerightsofallmembersofthehuman familyisthefoundationoffreedom,justiceandpeaceintheworld, Whereasdisregardandcontemptforhumanrightshaveresultedinbarbarousactswhichhaveoutragedthe conscienceofmankind,andtheadventofaworldinwhichhumanbeingsshallenjoyfreedomofspeechandbelief andfreedomfromfearandwanthasbeenproclaimedasthehighestaspirationofthecommonpeople, Whereasitisessential,ifmanisnottobecompelledtohaverecourse,asalastresort,torebellionagainsttyranny andoppression,thathumanrightsshouldbeprotectedbytheruleoflaw, Whereasitisessentialtopromotethedevelopmentoffriendlyrelationsbetweennations, WhereasthepeoplesoftheUnitedNationshaveintheCharterreaffirmedtheirfaithinfundamentalhuman rights,inthedignityandworthofthehumanpersonandintheequalrightsofmenandwomenandhave determinedtopromotesocialprogressandbetterstandardsoflifeinlargerfreedom, WhereasMemberStateshavepledgedthemselvestoachieve,incooperationwiththeUnitedNations,the promotionofuniversalrespectforandobservanceofhumanrightsandfundamentalfreedoms, Whereasacommonunderstandingoftheserightsandfreedomsisofthegreatestimportanceforthefull realizationofthispledge, Now,therefore, TheGeneralAssembly, ProclaimsthisUniversalDeclarationofHumanRightsasacommonstandardofachievementforallpeoplesand allnations,totheendthateveryindividualandeveryorganofsociety,keepingthisDeclarationconstantlyin mind,shallstrivebyteachingandeducationtopromoterespectfortheserightsandfreedomsandbyprogressive measures,nationalandinternational,tosecuretheiruniversalandeffectiverecognitionandobservance,both amongthepeoplesofMemberStatesthemselvesandamongthepeoplesofterritoriesundertheirjurisdiction. Article1.Allhumanbeingsarebornfreeandequalindignityandrights.Theyareendowedwithreasonand conscienceandshouldacttowardsoneanotherinaspiritofbrotherhood.
Source: Retrieved September 14, 2009, from www.everyhumanhasrights.org/universal-declaration/read-it
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Appendix C: Every Human Has Rights Declaration (cont.)
Article2.EveryoneisentitledtoalltherightsandfreedomssetforthinthisDeclaration,withoutdistinctionof anykind,suchasrace,colour,sex,language,religion,politicalorotheropinion,nationalorsocialorigin,property, birthorotherstatus. Furthermore,nodistinctionshallbemadeonthebasisofthepolitical,jurisdictionalorinternationalstatusofthe countryorterritorytowhichapersonbelongs,whetheritbeindependent,trust,nonselfgoverningorunderany otherlimitationofsovereignty. Article3.Everyonehastherighttolife,libertyandsecurityofperson. Article4.Nooneshallbeheldinslaveryorservitude;slaveryandtheslavetradeshallbeprohibitedinalltheir forms. Article5.Nooneshallbesubjectedtotortureortocruel,inhumanordegradingtreatmentorpunishment. Article6.Everyonehastherighttorecognitioneverywhereasapersonbeforethelaw. Article7.Allareequalbeforethelawandareentitledwithoutanydiscriminationtoequalprotectionofthelaw. AllareentitledtoequalprotectionagainstanydiscriminationinviolationofthisDeclarationandagainstany incitementtosuchdiscrimination. Article8.Everyonehastherighttoaneffectiveremedybythecompetentnationaltribunalsforactsviolatingthe fundamentalrightsgrantedhimbytheconstitutionorbylaw. Article9.Nooneshallbesubjectedtoarbitraryarrest,detentionorexile. Article10.Everyoneisentitledinfullequalitytoafairandpublichearingbyanindependentandimpartial tribunal,inthedeterminationofhisrightsandobligationsandofanycriminalchargeagainsthim. Article11.1.Everyonechargedwithapenaloffencehastherighttobepresumedinnocentuntilprovedguilty accordingtolawinapublictrialatwhichhehashadalltheguaranteesnecessaryforhisdefense. 2.Nooneshallbeheldguiltyofanypenaloffenceonaccountofanyactoromissionwhichdidnotconstitutea penaloffence,undernationalorinternationallaw,atthetimewhenitwascommitted.Norshallaheavierpenalty beimposedthantheonethatwasapplicableatthetimethepenaloffencewascommitted. Article12.Nooneshallbesubjectedtoarbitraryinterferencewithhisprivacy,family,homeorcorrespondence, nortoattacksuponhishonorandreputation.Everyonehastherighttotheprotectionofthelawagainstsuch interferenceorattacks. Article13.1.EveryonehastherighttofreedomofmovementandresidencewithinthebordersofeachState. 2.Everyonehastherighttoleaveanycountry,includinghisown,andtoreturntohiscountry. Article14.1.Everyonehastherighttoseekandtoenjoyinothercountriesasylumfrompersecution. 2.Thisrightmaynotbeinvokedinthecaseofprosecutionsgenuinelyarisingfromnonpoliticalcrimesorfrom actscontrarytothepurposesandprinciplesoftheUnitedNations.
Source: Retrieved September 14, 2009, from www.everyhumanhasrights.org/universal-declaration/read-it
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Appendix C: Every Human Has Rights Declaration (cont.)
Article15.1.Everyonehastherighttoanationality. 2.Nooneshallbearbitrarilydeprivedofhisnationalitynordeniedtherighttochangehisnationality. Article16.1.Menandwomenoffullage,withoutanylimitationduetorace,nationalityorreligion,havetheright tomarryandtofoundafamily.Theyareentitledtoequalrightsastomarriage,duringmarriageandatits dissolution. 2.Marriageshallbeenteredintoonlywiththefreeandfullconsentoftheintendingspouses. 3.Thefamilyisthenaturalandfundamentalgroupunitofsocietyandisentitledtoprotectionbysocietyandthe State. Article17.1.Everyonehastherighttoownpropertyaloneaswellasinassociationwithothers. 2.Nooneshallbearbitrarilydeprivedofhisproperty. Article18.Everyonehastherighttofreedomofthought,conscienceandreligion;thisrightincludesfreedomto changehisreligionorbelief,andfreedom,eitheraloneorincommunitywithothersandinpublicorprivate,to manifesthisreligionorbeliefinteaching,practice,worshipandobservance. Article19.Everyonehastherighttofreedomofopinionandexpression;thisrightincludesfreedomtohold opinionswithoutinterferenceandtoseek,receiveandimpartinformationandideasthroughanymediaand regardlessoffrontiers. Article20.1.Everyonehastherighttofreedomofpeacefulassemblyandassociation. 2.Noonemaybecompelledtobelongtoanassociation. Article21.1.Everyonehastherighttotakepartinthegovernmentofhiscountry,directlyorthroughfreely chosenrepresentatives. 2.Everyonehastherighttoequalaccesstopublicserviceinhiscountry. 3.Thewillofthepeopleshallbethebasisoftheauthorityofgovernment;thiswillshallbeexpressedinperiodic andgenuineelectionswhichshallbebyuniversalandequalsuffrageandshallbeheldbysecretvoteorby equivalentfreevotingprocedures. Article22.Everyone,asamemberofsociety,hastherighttosocialsecurityandisentitledtorealization,through nationaleffortandinternationalcooperationandinaccordancewiththeorganizationandresourcesofeach State,oftheeconomic,socialandculturalrightsindispensableforhisdignityandthefreedevelopmentofhis personality. Article23.1.Everyonehastherighttowork,tofreechoiceofemployment,tojustandfavorableconditionsof workandtoprotectionagainstunemployment. 2.Everyone,withoutanydiscrimination,hastherighttoequalpayforequalwork. 3.Everyonewhoworkshastherighttojustandfavorableremunerationensuringforhimselfandhisfamilyan existenceworthyofhumandignity,andsupplemented,ifnecessary,byothermeansofsocialprotection.
Source: Retrieved September 14, 2009, from www.everyhumanhasrights.org/universal-declaration/read-it
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Appendix C: Every Human Has Rights Declaration (cont.)
4.Everyonehastherighttoformandtojointradeunionsfortheprotectionofhisinterests. Article24.Everyonehastherighttorestandleisure,includingreasonablelimitationofworkinghoursand periodicholidayswithpay. Article25.1.Everyonehastherighttoastandardoflivingadequateforthehealthandwellbeingofhimselfand ofhisfamily,includingfood,clothing,housingandmedicalcareandnecessarysocialservices,andtherightto securityintheeventofunemployment,sickness,disability,widowhood,oldageorotherlackoflivelihoodin circumstancesbeyondhiscontrol. 2.Motherhoodandchildhoodareentitledtospecialcareandassistance.Allchildren,whetherborninoroutof wedlock,shallenjoythesamesocialprotection. Article26.1.Everyonehastherighttoeducation.Educationshallbefree,atleastintheelementaryand fundamentalstages.Elementaryeducationshallbecompulsory.Technicalandprofessionaleducationshallbe madegenerallyavailableandhighereducationshallbeequallyaccessibletoallonthebasisofmerit. 2.Educationshallbedirectedtothefulldevelopmentofthehumanpersonalityandtothestrengtheningof respectforhumanrightsandfundamentalfreedoms.Itshallpromoteunderstanding,toleranceandfriendship amongallnations,racialorreligiousgroups,andshallfurthertheactivitiesoftheUnitedNationsforthe maintenanceofpeace. 3.Parentshaveapriorrighttochoosethekindofeducationthatshallbegiventotheirchildren. Article27.1.Everyonehastherightfreelytoparticipateintheculturallifeofthecommunity,toenjoythearts andtoshareinscientificadvancementanditsbenefits. 2.Everyonehastherighttotheprotectionofthemoralandmaterialinterestsresultingfromanyscientific, literaryorartisticproductionofwhichheistheauthor. Article28.Everyoneisentitledtoasocialandinternationalorderinwhichtherightsandfreedomssetforthin thisDeclarationcanbefullyrealized. Article29.1.Everyonehasdutiestothecommunityinwhichalonethefreeandfulldevelopmentofhis personalityispossible. 2.Intheexerciseofhisrightsandfreedoms,everyoneshallbesubjectonlytosuchlimitationsasaredetermined bylawsolelyforthepurposeofsecuringduerecognitionandrespectfortherightsandfreedomsofothersandof meetingthejustrequirementsofmorality,publicorderandthegeneralwelfareinademocraticsociety. 3.TheserightsandfreedomsmayinnocasebeexercisedcontrarytothepurposesandprinciplesoftheUnited Nations. Article30.NothinginthisDeclarationmaybeinterpretedasimplyingforanyState,grouporpersonanyrightto engageinanyactivityortoperformanyactaimedatthedestructionofanyoftherightsandfreedomssetforth herein.
Source: Retrieved September 14, 2009, from www.everyhumanhasrights.org/universal-declaration/read-it
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Appendix D: Key Aspects of a Sustainable Healthcare System
GLAXOSMITHKLINE
BRIEFI NGS
Key Aspects of a Sustainable Healthcare System Introduction Governments across the world are looking for ways to bring into balance a number of competing policy goals: economic growth; industrial development; attraction of foreign direct investment; advances in education, science and technology; overall budgetary control; complex and evolving healthcare needs. Balancing options is especially hard in the area of healthcare. Market-based pricing for reimbursed pharmaceuticals, in which companies are free to set prices and there are no supply-side or demand-side controls, remains the industry’s preferred solution to meeting the needs of patients and society’s demand for better medical treatment. However, markets in Europe and the International region tend instead to be characterized by monopsonistic payer structures, over-regulation, poor resource allocation, slow access for new medicines, and a focus on cost rather than value. Against this background, this paper outlines the elements which GSK believes most effectively deliver sustainable and efficient healthcare systems. Not all of these elements may be relevant or appropriate to every country. However, governments are urged to review some, if not all of them, as they consider how best to meet the challenge of establishing a healthcare policy that meets the needs of all key stakeholders, namely patients (who want rapid access to the best treatments), payers (who want to deliver good healthcare to their citizens and manage budgets) and the industry (which wants to secure a return on investment that will incentivise further innovation). Key Elements 1.
Healthcare priorities should be identified through improved and earlier dialogue
National healthcare systems and policies should ensure that the right capabilities are put in place for defining treatment priorities within each individual disease area and for identifying disease management targets. Industry and government should discuss these health priorities and targets as part of a 10-20 year strategic agenda and not just as part of cost containment measures over the next 6 months. This will enable the development of new medicines, to help ensure that unmet need is addressed, disease prioritisation is clear and patients get access to the medicines that will improve their lives.
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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Appendix D: Key Aspects of a Sustainable Healthcare System (cont.)
GLAXOSMITHKLINE
BRIEFINGS
Predictability is created by earlier and more in-depth interaction with healthcare payers to discuss specific data that payers require in order to decide on the reimbursement of a product. At present, dialogue generally starts once a medicine has been approved and the data generated. It is often conducted in a manner that lacks predictability and coherence. 2.
Healthcare funding should be adequate and sustainable
Resources should be allocated where quality is achieved and outcomes are maximised. Ways of achieving this include: x x
x
x
x x
x
x
x
improved prevention. Chronic diseases are among the most prevalent, costly and preventable of all healthcare problems. By encouraging prevention, healthcare will be improved and huge healthcare spending avoided. driving out waste. Efficient practice (prevention, diagnosis, treatment, rehabilitation) will lead to savings for the healthcare system as a whole. With respect to pharmaceuticals, policies for proper usage of medicines in both qualitative and quantitative terms should be promoted and implemented, with a view to freeing up resources for use elsewhere in the system. integrating care of chronic diseases and viewing drug budgets in the context of healthcare overall. Silo-budgeting should be eliminated because a focus on medicines expenditure leads governments to seek a disproportionate contribution to cost containment from pharmaceuticals. developing a greater awareness of the cost-effectiveness of innovative medicines. For example, an increase in medicines spending in the treatment of Alzheimer’s can lead to greater overall savings. Governments should identify and target savings and redirect expenditure towards innovative drugs. recognising the importance and value of comprehensive vaccination programmes in the context of investing in cost-effective preventative care taking account of the existence and benefits of new technologies. The benefits can refer to their cost-efficiency in relation to hospital-based interventions or to advantages for patients in terms of convenience, improved quality of life etc. A focus on cost, rather than value, will not meet the budgetary goals of governments. strengthening/establishing primary care services and avoiding misuse and overuse of medical services; an ambulatory care system should be developed. This includes a GP referral system, the development of community care centres with focus on health promotion and disease prevention, and further development of the role of pharmacists. reassessing the organisation of hospitals and the number of acute hospital beds in light of current medical needs and available technologies; innovative therapies and medicines can reduce the length of stay or avoid hospitalisation and should therefore be encouraged. promoting appropriate use of over-the-counter/self medication products : Governments should encourage the appropriate use of self medication products as a means of relieving pressure on public healthcare systems (ie. physician appointments) and of freeing up financial resources for innovative products.
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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Appendix D: Key Aspects of a Sustainable Healthcare System (cont.)
GLAXOSMITHKLINE
BRIEFINGS
New funding sources for healthcare should be considered: Systems in which the government is the sole purchaser of medicines are likely to be unsustainable in the medium to long-term. Governments should look at new funding options, including; x x
x
a greater role for private health insurance increased patient co-payment, in a way that encourages compliance and cost-effective use of medicines while ensuring that low-income and other vulnerable groups are not excluded or discouraged from seeking and receiving medical care. Any move to a situation where people are prepared or required to contribute more to healthcare costs will require a process of education and communication, especially in view of the fact that currently patients remain reticent to pay additional charges to their prescription. There is a clear risk that patients perceive that a medicine’s value is somehow questionable if the Government does not fully reimburse it. new or increased taxation on products and behaviours, like fast foods and smoking, which increase healthcare costs. Tax revenues from these sources should be dedicated to healthcare budgets.
An acceptance by citizens that they need to pay more for healthcare is critical. Shifting more costs onto consumers of healthcare will make them more demanding, hungrier for information and more sensitive to value. Together patients and doctors can work on adopting the most cost-effective treatments and thereby help to reduce the inefficient use of healthcare facilities. 3. Pricing and Reimbursement policies should reflect the true value of “innovation”. Society is on the brink of a new era in which pharmaceutical research in genomics and pharmacogenetics will yield an entirely new class of medical interventions with respect to prevention, detection, treatment and cure. This will throw a radically new light on the concept of effectiveness (tailored medicine with much higher rates of success) and cost (tailored medicine instead of one-size fits all). The nature of drug development, however, remains highly unpredictable. There is no guarantee that the first drug to market will be the best. Some new medicines will be revolutionary breakthroughs. Others will deliver incremental benefits over existing treatments, be it in efficacy, improved tolerability or improved mode of administration. Products that deliver incremental innovation provide alternatives for patients that do not respond well to the first product in class. They also create competition, thereby driving price and value optimisation and provide the path to more radical change Where payers seek value for money, pharmaceutical companies require money for value. The reward society gives to an innovative medicine must reflect its added therapeutic value. Reward for innovation can come in different forms, not just a premium price - e.g. unrestricted access to the patient population defined as needing new therapy, therapeutic guidelines recognising a new therapy, and speed of access.
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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Appendix D: Key Aspects of a Sustainable Healthcare System (cont.)
GLAXOSMITHKLINE
BRIEFINGS
Products should not be punished for success – high volume, and high favourability with prescribers, should not make products the targets for cuts. Payers should not increase volumes for proven value only to reduce price. Reimbursement systems should reward medicines by taking into account measures of success, (whether these are available at launch or during a product’s life-cycle) and that are in line with the way markets function ie. quality, health outcome evidence, physicians’ prescribing etc. Rather than being dominated by short-termism and ad-hoc measures, pricing and reimbursement systems must allow business planning for long-term supply of medicines and encourage R&D investment in medicines that count. 4. Tools for measuring “innovation” should be appropriate The evaluation of a medicine’s value must deliver a reasonable balance between the interests of payers (better management of budgets), patients (better access and outcomes), physicians (better outcomes), and industry (appropriate reward for innovation). Health technology assessment (HTA) is one of the tools, when appropriately defined and applied, that can contribute to an assessment of clinical effectiveness and cost-effectiveness of new medicines and new technologies (including medical devices). Certain key principles should underpin any HTA system. x x
x x x x
x
the process should be inclusive and involve early dialogue with industry around the aims and priorities of the process. there should be clarity and consensus on the criteria against which therapeutic progress (or value) can be measured throughout a product’s lifecycle. The measures of value can include: mortality and morbidity data, side-effects, tolerability, predictive surrogate parameters, pharmaceutical form, route of application, compliance, ease of use, impact on the healthcare service, disease severity, medical need, quality of life, and patient preferences. the evaluation process should be independent, transparent and scientifically robust. Where HTAs are focussed on delivering guidance, the evaluating body should be independent of the payer. evaluation systems should be clear and consistent with regards to methodology, criteria used and data required – this would include clear timeframes for the evaluation and for any decisions arising from it patients, physicians and the industry should be involved in the assessment process, to allow for a better evaluation of the balance between benefits, costs and risk. pharmaceutical companies should be able to submit health outcomes information to the relevant government bodies throughout a product’s lifecycle. This evidence should then receive appropriate attention and reward from payers. A ‘one size fits all’ approach to the timing of appraisals fails to take account of the complexity of conducting assessments and ignores differences in treatments and therapeutic areas. the HTA should be separate from the regulatory review for the grant of a marketing authorisation. Regulatory review must be based on objective and scientifically verifiable criteria of efficacy, safety and quality. HTA should not become a fourth hurdle in marketing authorisation.
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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Appendix D: Key Aspects of a Sustainable Healthcare System (cont.)
GLAXOSMITHKLINE
BRIEFINGS
5. Increased access to information for patients should be actively encouraged Citizens and patients should be at the centre of many key aspects of healthcare as well as medicines policy – such as assessments of value, decisions on access, and allocation of funding. This can only work, however, if there is sufficient information available to them patients should be given the ability to make choices, and should receive the information to choose wisely. Industry should be involved in this initiative. Disease education and vaccines information campaigns are an example of how responsible, approved information from the industry to the public can fulfil a number of objectives: raising public awareness of the existence of a safe and effective vaccine; educating the public of the risks attached to non-vaccination; allowing important savings to be achieved for healthcare systems by preventing disease; and contributing to the overall "wellness" of society. 6.
Free pricing for non-reimbursed medicines should be allowed
When governments negotiate, they should only negotiate for the prices of what they purchase or reimburse; sales outside the state system should be subject to the normal rules of market pricing. 7.
Generics should play an appropriate part in treatment options
Appropriate use of generics can deliver savings in healthcare expenditure and free up resources to reward innovation. However, a more competitive market is required to enable generics to yield the savings they promise. It is estimated that if the OECD utilised generics at the same rate and prices as in the US, savings of $5-30bn annually could result. To this end: x
x
generics should be commoditised, reflecting the limited innovation and investment that goes into their development. Price differences between generics and branded medicines should be visible and sufficiently large to allow healthcare systems to fully benefit from savings created by the use of generics. generic substitution should be used by governments and other payers to free up resources to reward innovation. Provided that physicians can make exceptions on medical grounds, a generics policy, including a system that encourages competitive generic prices, will free up resources that should be used to reward innovation.
8. Use of OTC products should be encouraged Policies encouraging the use of over-the-counter medicines should be actively implemented where medicines provide a clear health benefit to patients and are sufficiently safe to warrant OTC status. These policies should include Government support for products with a long history of safe use being switched from prescription to non-prescription. The advertising and promotion of these products should also be liberalised.
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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GLAXOSMITHKLINE
9.
BRIEFINGS
Effective regulatory systems should be established
A well-regarded registration process for new pharmaceutical products that enables medicines to gain international credibility by passing stringent criteria on quality, safety and efficacy will encourage pharmaceutical companies to conduct clinical trials and launch innovative products early. Key regulations should be conducive to the development and early adoption of innovative new drugs. 10.
IP should be respected
A strong legal framework on intellectual property rights creates a desirable environment for research and development. Enactment and enforcement of international patent protection and registration data exclusivity to reward innovation and allow funding of R&D in an era of escalating technology development costs is a key factor. September 2006
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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Appendix E: 2009 Notice of Annual GlaxoSmithKline Shareholder Meeting
GlaxoSmithKline plc Notice of Annual General Meeting 2.30pm on Wednesday, 20th May 2009
This document is important and requires your immediate attention. If you are in any doubt as to what action you should take, you should consult your stockbroker, bank manager, solicitor, accountant or other professional advisor immediately. If you have sold or otherwise transferred all of your shares, please pass this document, together with the accompanying documents, to the purchaser or transferee, or to the person who arranged the sale or transfer so they can pass these documents to the person who now holds the shares.
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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Appendix E: 2009 Notice of Annual GlaxoSmithKline Shareholder Meeting 24th March 2009 To the holders of the company’s Ordinary shares and American Depositary Shares and, for information, to the holders of the SmithKline Beecham plc Floating Rate Unsecured Loan Stock. Dear Shareholder, Annual General Meeting 2009 I am pleased to enclose the Notice of Meeting for the ninth Annual General Meeting (the “AGM”) of GlaxoSmithKline plc together with the 2008 Annual Report and 2008 Summary. The AGM will be held at 2.30pm on Wednesday, 20th May 2009 at the Queen Elizabeth II Conference Centre, Broad Sanctuary, Westminster, London SW1P 3EE. If you will not be attending, you may appoint a proxy electronically via www.shareview. co.uk or www.sharevote.co.uk or if you hold your shares in CREST via the CREST system or by completing and returning the enclosed form of proxy. In each case, notice of your appointment of a proxy should reach the company’s registrars no later than 2.30pm on Monday, 18th May 2009. A resolution referring to the Financial Statements is included in the ordinary business of the AGM. Our Articles of Association require that certain of our current Directors retire by rotation. I therefore ask you to support the re-election of Mr Larry Culp, Sir Crispin Davis, Dr Moncef Slaoui and Mr Tom de Swaan who will each retire and offer themselves for re-election. Sir Ian Prosser and Dr Schmitz will also be retiring, but will not be seeking re-election. They are to retire from the Board at the end of the AGM. In addition, a resolution is proposed covering the formal election of a new Non-Executive Director, Mr James Murdoch, who has been appointed to the Board with effect from 20th May 2009. Resolutions are proposed in the special business of the AGM to approve the adoption of three new share-based remuneration plans: the GlaxoSmithKline 2009 Performance Share Plan, the GlaxoSmithKline 2009 Share Option Plan and the GlaxoSmithKline 2009 Deferred Annual Bonus Plan, as part of the new Remuneration Policy. Full details of how these plans will be implemented under the new policy can be found in the 2008 Annual Report. The key terms of the new plans are set out in the explanatory notes on pages 14 to 20 of the Notice of Meeting. In addition, resolutions are proposed to retain a notice period for general meetings other than an AGM of 14 days in preparation for the implementation of the EU Shareholder Rights Directive and, following the implementation of the Companies Act 2006, to omit from the published copies of the company’s 2009 Annual Report, the name of the individual who signs the Auditors’ reports on behalf of GSK’s Auditors. Explanatory notes for all the business of the AGM are given on pages 10 to 20 of this document. Recommendation Your Board believes that the resolutions contained in the Notice of Meeting are in the best interests of the company and shareholders as a whole and recommends you to vote in favour of them, as your Directors intend to do in respect of their beneficial shareholdings. Yours sincerely,
Sir Christopher Gent Chairman GlaxoSmithKline plc
2
Registered in England & Wales No. 3888792 Registered office: 980 Great West Road, Brentford Middlesex TW8 9GS
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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GlaxoSmithKline Notice of Meeting Notice is hereby given that the ninth Annual General Meeting of GlaxoSmithKline plc will be held at the Queen Elizabeth II Conference Centre, Broad Sanctuary, Westminster, London SW1P 3EE on Wednesday, 20th May 2009 at 2.30pm to consider and, if thought fit, pass the following resolutions. All resolutions will be proposed as ordinary resolutions, save for resolutions 12, 13 and 15 which will be proposed as special resolutions. Ordinary Business 1 To receive and adopt the Directors’ Report and the Financial Statements for the year ended 31st December 2008. 2
To approve the Remuneration Report for the year ended 31st December 2008.
3
To elect Mr James Murdoch as a Director.
4
To re-elect Mr Larry Culp as a Director.
5
To re-elect Sir Crispin Davis as a Director.
6
To re-elect Dr Moncef Slaoui as a Director.
7
To re-elect Mr Tom de Swaan as a Director.
8
To authorise the Audit Committee to re-appoint PricewaterhouseCoopers LLP as Auditors to the company to hold office from the end of the Meeting to the end of the next Meeting at which accounts are laid before the company.
9
To authorise the Audit Committee to determine the remuneration of the Auditors.
Special Business 10 Donations to political organisations & political expenditure (Ordinary resolution) THAT, in accordance with section 366 of the Companies Act 2006 (the “2006 Act”) the company is, and all companies that are at any time during the period for which this resolution has effect subsidiaries of the company are, authorised: (a) to make political donations to political organisations other than political parties, as defined in section 363 of the 2006 Act, not exceeding £50,000 in total; and (b) to incur political expenditure, as defined in section 365 of the 2006 Act, not exceeding £50,000 in total, during the period beginning with the date of passing this resolution and ending at the end of the next Annual General Meeting of the company to be held in 2010 or, if earlier, on 30th June 2010. 11 Authority to allot shares (Ordinary resolution) THAT the Directors be and are hereby generally and unconditionally authorised, in substitution for all subsisting authorities, to exercise all powers of the company to allot relevant securities (within the meaning of section 80 of the Companies Act 1985 (the “1985 Act”)): (a) up to an aggregate nominal amount of £432,359,137; and (b) comprising equity securities (as defined in the 1985 Act) up to a nominal amount of £864,692,333 (after deducting from such limit any relevant securities allotted under paragraph (a) above) in connection with an offer by way of a rights issue: 3
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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(i) to ordinary shareholders in proportion (as nearly as may be practicable) to their existing holdings; and (ii) to holders of other equity securities as required by the rights of those securities or as the Board otherwise considers necessary, and so that the Directors may make such exclusions or other arrangements as they consider expedient in relation to fractional entitlements, legal or practical problems under the laws of, or the requirements of any relevant regulatory body or stock exchange in, any territory, or any matter whatsoever, which authorities shall expire at the end of the next Annual General Meeting of the company to be held in 2010 or, if earlier, on 30th June 2010 (unless previously revoked or varied by the company in general meeting) save that under each authority the company may, before such expiry, make an offer or agreement which would or might require relevant securities to be allotted after such expiry and the Directors may allot relevant securities in pursuance of such an offer or agreement as if the relevant authority conferred hereby had not expired. 12 Disapplication of pre-emption rights (Special resolution) THAT the Directors be and are hereby empowered pursuant to section 95 of the 1985 Act to allot equity securities (within the meaning of section 94 of the 1985 Act) for cash pursuant to the authority conferred on the Directors by Resolution 11 and/or where such allotment constitutes an allotment of equity securities by virtue of section 94(3A) of the 1985 Act as if section 89(1) of the 1985 Act did not apply to such allotment, provided that this power shall be limited: (a) to the allotment of equity securities in connection with an offer or issue of equity securities (but in the case of the authority granted under paragraph (b) of Resolution 11, by way of a rights issue only): (i) to ordinary shareholders in proportion (as nearly as may be practicable) to their existing holdings; and (ii) to holders of other equity securities, as required by the rights of those securities or as the Board otherwise considers necessary, but so that the Directors may make such exclusions or other arrangements as they consider expedient in relation to fractional entitlements, legal or practical problems under the laws of, or the requirements of any relevant regulatory body or stock exchange, in any territory, or any matter whatsoever; and (b) in the case of the authority granted under paragraph (a) of Resolution 11, to the allotment (otherwise than pursuant to sub-paragraph (a) above) of equity securities up to an aggregate nominal amount of £64,854,519, and shall expire at the end of the next Annual General Meeting of the company to be held in 2010 or, if earlier, on 30th June 2010, save that the company may before such expiry make an offer or agreement which would or might require equity securities to be allotted after such expiry and the Directors may allot equity securities in pursuance of such an offer or agreement as if the power conferred hereby had not expired. 13 Purchase of own shares by the company (Special resolution) THAT the company be and is hereby generally and unconditionally authorised for the purposes of section 166 of the 1985 Act to make market purchases (within the meaning of section 163 of the 1985 Act) of its own Ordinary shares of 25p each provided that: 4
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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(a) the maximum number of Ordinary shares hereby authorised to be purchased is 518,836,153; (b) the minimum price which may be paid for each Ordinary share is 25p; (c) the maximum price which may be paid for each Ordinary share shall be the higher of (i) an amount equal to 105% of the average of the middle market quotations for the company’s Ordinary shares as derived from the London Stock Exchange Daily Official List for the five business days immediately preceding the day on which the Ordinary share is contracted to be purchased and (ii) the higher of the price of the last independent trade and the highest current independent bid on the London Stock Exchange Official List at the time the purchase is carried out; and (d) the authority conferred by this resolution shall, unless renewed prior to such time, expire at the end of the next Annual General Meeting of the company to be held in 2010 or, if earlier, on 30th June 2010 (provided that the company may enter into a contract for the purchase of Ordinary shares before the expiry of this authority which would or might be completed wholly or partly after such expiry). 14 Exemption from statement of the name of the senior statutory auditor in published copies of the Auditors’ reports (Ordinary resolution) THAT: (a) in accordance with section 506 of the 2006 Act, the name of the person who signs the Auditors’ reports to the company’s members on the annual accounts and auditable reports of the company for the year ending 31st December 2009 as senior statutory auditor (as defined in section 504 of the 2006 Act) for and on behalf of the company’s Auditors, should not be stated in published copies of the reports (such publication being as defined in section 505 of the 2006 Act) and the copy of the reports to be delivered to the registrar of companies under Chapter 10 of Part 15 of the 2006 Act; and (b) the company considers on reasonable grounds that statement of the name of the senior statutory auditor would create or be likely to create a serious risk that the senior statutory auditor, or any other person, would be subject to violence or intimidation. 15 Reduced notice of a general meeting other than an annual general meeting (Special resolution) THAT a general meeting of the company other than an Annual General Meeting may be called on not less than 14 clear days’ notice. 16 Approval of the adoption of the GlaxoSmithKline 2009 Performance Share Plan (Ordinary resolution) THAT the adoption of the GlaxoSmithKline 2009 Performance Share Plan (the “PSP”), the principal features of which are summarised in the explanatory notes to this Notice and the rules of which have been signed for the purposes of identification by the Chairman, be and is hereby approved and the Directors are hereby authorised to: (a) do whatever may be necessary or expedient to carry the PSP into effect, including making such modifications to the PSP as they may consider appropriate to take account of the requirements of the UK Listing Authority and best practice; and
5
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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(b) establish further plans for the benefit of employees outside the UK, based on the PSP but modified to take account of local tax, exchange control or securities laws in overseas territories, provided that any shares made available under such plans are treated as counting against the limits on individual and overall participation contained in the PSP. 17 Approval of the adoption of the GlaxoSmithKline 2009 Share Option Plan (Ordinary resolution) THAT the adoption of the GlaxoSmithKline 2009 Share Option Plan (the “SOP”), the principal features of which are summarised in the explanatory notes to this Notice and the rules of which have been signed for the purposes of identification by the Chairman, be and is hereby approved and the Directors are hereby authorised to: (a) do whatever may be necessary or expedient to carry the SOP into effect, including making such modifications to the SOP as they may consider appropriate to take account of the requirements of the UK Listing Authority and best practice; and (b) establish further plans for the benefit of employees outside the UK, based on the SOP but modified to take account of local tax, exchange control or securities laws in overseas territories, provided that any shares made available under such plans are treated as counting against the limits on individual and overall participation contained in the SOP. 18 Approval of the adoption of the GlaxoSmithKline 2009 Deferred Annual Bonus Plan (Ordinary resolution) THAT the adoption of the GlaxoSmithKline 2009 Deferred Annual Bonus Plan (the “DABP”), the principal features of which are summarised in the explanatory notes to this Notice and the rules of which have been signed for the purposes of identification by the Chairman, be and is hereby approved and the Directors are hereby authorised to: (a) do whatever may be necessary or expedient to carry the DABP into effect, including making such modifications to the DABP as they may consider appropriate to take account of the requirements of the UK Listing Authority and best practice; and (b) establish further plans for the benefit of employees outside the UK, based on the DABP but modified to take account of local tax, exchange control or securities laws in overseas territories, provided that any shares made available under such plans are treated as counting against the limits on individual and overall participation contained in the DABP.
By Order of the Board Simon Bicknell Company Secretary 24th March 2009
Registered Office: 980 Great West Road Brentford, Middlesex TW8 9GS Registered in England and Wales No. 3888792
6
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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Notes
(i)
All resolutions at the Meeting will be decided by poll as required by the company’s Articles of Association.
(ii)
A “Vote Withheld” option is provided on the proxy card accompanying this Notice of Meeting which is to enable a member (shareholder) to withhold their vote on any particular resolution. It should be noted that a vote withheld is not a vote in law and will not be counted in the calculation of the proportion of votes “For” or “Against” a resolution.
(iii) A member of the company is entitled to appoint one or more proxies to attend the Meeting, and to speak and vote on his behalf, provided that each proxy is appointed to exercise the rights attached to a different share or shares held by that member. A proxy need not be a member of the company. To appoint a proxy you may: (a) register the appointment of your proxy vote electronically using the internet by going to www.sharevote.co.uk and following the instructions provided. The proxy appointment must be received by the company’s registrars, Equiniti, by 2.30pm on Monday, 18th May 2009. Please note that any electronic communication sent to the company’s registrars in respect of the appointment of a proxy that is found to contain a computer virus will not be accepted; or (b) use the proxy card enclosed with this Notice of Meeting which should be returned direct to Equiniti at the address below, so as to be received no later than 2.30pm on Monday, 18th May 2009; or (c) if you hold your shares in uncertificated form, you should utilise the CREST electronic proxy appointment service by using the procedures described in the CREST Manual. CREST Personal Members or other CREST sponsored members, and those CREST members who have appointed a service provider(s), should refer to their CREST sponsor or voting service provider(s), who will be able to take the appropriate action on their behalf. Further details of voting via CREST are also given on page 23 of this document. If you do not have a proxy card and believe that you should have one, or if you require additional proxy cards, please contact Equiniti on the numbers given below. The return of a completed proxy card, other instrument or any CREST Proxy Instruction (as described in the section entitled “Information on how to vote” below) will not prevent a member attending the Meeting and voting in person if he/she wishes to do so. Equiniti can be contacted by post at: Equiniti Limited FREEPOST SEA 10846 Aspect House Spencer Road Lancing West Sussex BN99 6ZL or by telephone on 0871 384 2991* if calling from within the UK, or on +44 (0)121 415 7067 if calling from outside the UK. *At the time of publication, calls to this number were charged at 8p per minute from a BT landline. The prices charged by BT and other telephony providers may change from time to time. 7
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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(iv) Holders of the company’s American Depositary Shares evidenced by American Depositary Receipts (“ADRs”) may exercise their votes through the Depositary, The Bank of New York Mellon. Such holders wishing to attend the Meeting should obtain prior authority by being nominated an “Appointed Proxy” by the Depositary, who can be contacted at: BNY Mellon Shareowner Services P.O. Box 358516 Pittsburgh, PA 15252-8516 USA Tel: 1 877 353 1154 (US toll free) + 1 212 815 6825 (outside US) (v)
Participants in the company’s Corporate Sponsored Nominee service may exercise their votes through the company’s registrars, Equiniti, by using the form of direction enclosed with this Notice of Meeting, which should be returned direct to Equiniti at the address in Note (iii) above, so as to be received no later than 2.30pm on Saturday, 16th May 2009.
(vi) Any person to whom this Notice is sent who is a person nominated under section 146 of the 2006 Act to enjoy information rights (a “Nominated Person”) may, under an agreement between him/her and the member by whom he/she was nominated, have a right to be appointed (or to have someone else appointed) as a proxy for the Meeting. If a Nominated Person has no such proxy appointment right or does not wish to exercise it, he/she may, under any such agreement, have a right to give instructions to the member as to the exercise of voting rights. (vii) The statement of the rights of members in relation to the appointment of proxies in paragraph (iii) above does not apply to Nominated Persons. The rights described in that paragraph can only be exercised by members of the company. (viii) Copies of contracts of service or, where applicable, letters of appointment, between Directors and the company or any of its subsidiaries are available for inspection at the company’s registered office given above during normal business hours (Saturdays, Sundays and public holidays excepted) and at the place of the Meeting on Wednesday, 20th May 2009 from 1.30pm until the end of the Meeting. (ix) The register of Directors’ interests in the shares of the company and its subsidiaries will also be available for inspection at the place of the Meeting on Wednesday, 20th May 2009 from 1.30pm until the end of the Meeting. (x)
The rules of the proposed GlaxoSmithKline 2009 Performance Share Plan, the GlaxoSmithKline 2009 Share Option Plan and the GlaxoSmithKline 2009 Deferred Annual Bonus Plan will be available for inspection at the company’s registered office given above and at One Bunhill Row, London, EC1Y 8YY during normal business hours (Saturdays, Sundays and public holidays excepted) from the date of this Notice until the conclusion of the Meeting and at the place of the Meeting on Wednesday, 20th May 2009 from 1.30pm until the end of the Meeting.
8
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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(xi) Members must be entered on the company’s register of members on Monday, 18th May 2009, at 6.00pm (or, in the event of an adjournment, 6.00pm on the date which is two days before the time of the adjourned meeting), to be entitled to attend and vote at the Meeting. Members may cast votes only in respect of shares of which they were registered holders at such time, and changes to the register of members after the relevant deadline shall be disregarded in determining the rights of any person to attend and vote at the Meeting. (xii) To facilitate voting by corporate representatives at the Meeting, arrangements will be put in place at the Meeting so that: (a) if a corporate member has appointed the Chairman of the Meeting as its corporate representative with instructions to vote on a poll in accordance with the directions of all the other corporate representatives for that member at the Meeting, then on a poll those corporate representatives will give voting directions to the Chairman and the Chairman will vote (or withhold a vote) as corporate representative in accordance with those directions; and (b) if more than one corporate representative for the same corporate member attends the Meeting but the corporate member has not appointed the Chairman of the Meeting as its corporate representative, a designated corporate representative will be nominated from those corporate representatives who attend, who will vote on a poll and the other corporate representatives will give voting directions to that designated corporate representative. Corporate members are referred to the guidance issued by the Institute of Chartered Secretaries and Administrators on proxies and corporate representatives (www.icsa.org.uk) for further details of this procedure. The guidance includes a sample form of representation letter if the Chairman is being appointed as described in (a) above.
9
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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GlaxoSmithKline Explanatory Notes to Business of the Annual General Meeting Ordinary Business Each resolution will be proposed as an ordinary resolution. This means that for each of the resolutions to be passed, more than half of the votes cast must be in favour of the resolution. Resolution 1 – To receive and adopt the Directors’ Report and the Financial Statements for 2008 For each financial year, the Directors must present the Directors’ Report, the audited Financial Statements and the independent Auditors’ reports to shareholders at a General Meeting. Resolution 2 – To approve the 2008 Remuneration Report In accordance with the Directors’ Remuneration Report Regulations 2002, shareholders are invited to vote on the Remuneration Report, which may be found on pages 78 to 98 of the 2008 Annual Report. Resolutions 3-7 – Election and Re-election of Directors The company’s Articles of Association require any Director newly appointed by the Board to retire at the first Annual General Meeting (“AGM”) after appointment. You are therefore asked to elect as a Director, Mr James Murdoch, who has been appointed by the Board since last year’s AGM. The Board considers that his experience of global business, marketing and communications will bring a unique and alternative perspective to the Board and he will also be an excellent addition to the Board’s Corporate Responsibility Committee, an area where he has shown particular leadership at BSkyB and News Corporation. The Board has determined that he will be an independent Non-Executive Director in accordance with the Combined Code on Corporate Governance. The Articles of Association also require certain of the current Directors to retire at each AGM dependent on their length of service and the period since their last re-election. All of the Directors are eligible to seek re-election by shareholders at the AGM, if they so wish. Mr Larry Culp, Sir Crispin Davis, Sir Ian Prosser, Dr Ronaldo Schmitz, Dr Moncef Slaoui and Mr Tom de Swaan are all retiring by rotation. Neither Sir Ian nor Dr Schmitz will seek re-election and will retire from the Board at the conclusion of the AGM. Mr Culp and Sir Crispin were elected to the Board in 2004. Dr Slaoui and Mr de Swaan were elected to the Board in 2006. Mr Culp, Sir Crispin, Dr Slaoui and Mr de Swaan each offer themselves for re-election at the AGM. The Chairman is satisfied that each of them continues to perform effectively and demonstrates commitment to their role including commitment of time for Board and committee meetings and their other duties. Mr Culp, Sir Crispin, and Mr de Swaan are all Non-Executive Directors and have letters of appointment rather than service contracts. Dr Slaoui has a service contract with a notice period of 12 months. The Non-Executive Directors’ letters of appointment and Executive Directors’ service contracts are available for inspection as specified in Note (viii) above. Biographical details for each of the Directors standing for election or re-election to the Board at the Meeting are given in the company’s 2008 Annual Report. In addition, current biographical details for each Director are maintained on www.gsk.com.
Resolutions 8 and 9 – To authorise the Audit Committee to re-appoint PricewaterhouseCoopers LLP as Auditors to the company and to determine their remuneration At every General Meeting at which accounts are presented to shareholders, the 10
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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company is required to appoint auditors to serve until the next such meeting. PricewaterhouseCoopers LLP have indicated that they are willing to continue as the company’s Auditors for another year. You are asked to re-appoint them and, following normal practice, to authorise the Audit Committee to determine their remuneration. Details of the company’s policy with regard to non-audit work and details of work undertaken by the Auditors and their remuneration are given in the company’s Annual Report which can be viewed on www.gsk.com.
Special Business Where resolutions are passed as special resolutions, in order for those resolutions to be passed at least three-quarters of the votes cast must be in favour of the resolution. Resolution 10 – Donations to political organisations & political expenditure (Ordinary resolution) The 2006 Act requires companies to obtain shareholder approval before they can make donations to EU political organisations or incur EU political expenditure. However, the company does not make and does not intend to make donations to political parties or independent election candidates, nor does it make any donations to EU political organisations or incur EU political expenditure. The definitions of political donations, political expenditure and political organisations used in the 2006 Act are very wide. In particular, the definition of political organisations may extend to bodies such as those concerned with policy review, law reform, the representation of the business community and special interest groups such as those concerned with the environment, which the company and its subsidiaries might wish to support. As a result, the definitions may cover legitimate business activities not in the ordinary sense considered to be political donations or political expenditure. Such activities are not designed to support any political party or independent election candidate or to influence public support for any political party or independent election candidate. The authority which the Board is requesting is a precautionary measure to ensure that the company and its subsidiaries do not inadvertently breach the 2006 Act. No payments have ever been made under this authority, which is specific to political donations and political expenditure in relation to any and all EU member states. In addition, with effect from 1st January 2009, to ensure a consistent approach to political contributions across the GSK group, the company introduced a global policy to voluntarily stop all political contributions. In the past, GSK, in common with many companies and in full compliance with local laws, has made a number of political contributions in countries outside the EU, such as the US and Canada. Further details of the payments made in 2008 can be found in the 2008 Annual Report.
Resolution 11 – Authority to allot shares (Ordinary resolution) Paragraph (a) of this resolution gives the Directors authority to allot unissued share capital with a nominal value of up to £432,359,137 (representing 1,729,436,548 Ordinary shares of 25 pence each) which, as at 24th February 2009, being the last practicable date prior to the publication of this Notice, represented just less than onethird of the issued share capital of the company (excluding treasury shares). In line with recent guidance issued by the Association of British Insurers, paragraph (b) of this resolution gives the Directors authority to allot Ordinary shares in connection with a rights issue in favour of ordinary shareholders with a nominal value of up to £864,692,333 (representing 3,458,769,332 Ordinary shares of 25 pence each), as reduced by the nominal amount of any shares issued under paragraph (a) of this resolution. This amount (before any reduction) represents just less than two-thirds of the issued ordinary share capital of the company (excluding treasury shares) as at 24th February 2009, being the last practicable date prior to publication of this Notice. 11
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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The authorities sought under paragraphs (a) and (b) of this resolution will expire at the earlier of 30th June 2010 (being the last date by which the company must hold an AGM in 2010) or the conclusion of the AGM of the company held in 2010. The Directors have no present intention to exercise either of the authorities sought under this resolution, except, under paragraph (a), to fulfil the company’s obligations under its executive and employee share plans.
Resolution 12 – Disapplication of pre-emption rights (Special resolution) This resolution gives the Directors authority to allot Ordinary shares (including any Ordinary shares which the company has purchased and elected to hold as treasury shares) for cash without first offering them to existing shareholders in proportion to their existing shareholdings and is limited to allotments in connection with rights issues or other pre-emptive offers, or otherwise up to a maximum nominal amount of £64,854,519 (representing 259,418,076 Ordinary shares of 25 pence each) which, as at 24th February 2009, being the last practicable date prior to the publication of this Notice, represented just less than 5% of the company’s issued share capital (excluding treasury shares). In respect of this aggregate nominal amount, the Directors confirm their intention to follow the provisions of the Pre-Emption Group’s Statement of Principles regarding cumulative usage of authorities within a rolling three-year period where the Principles provide that usage in excess of 7.5% should not take place without prior consultation with shareholders. This authority will expire at the earlier of 30th June 2010 or the conclusion of the AGM of the company in 2010. This authority is granted under section 95 of the 1985 Act and is a standard annual resolution for most UK companies listed on the London Stock Exchange.
Resolution 13 – Purchase of own shares by the company (Special resolution) This resolution seeks authority for the company to make market purchases of its own Ordinary shares. Purchases of the company’s own shares will be made only after considering the effects on earnings per share and the benefits for shareholders generally. The company does not expect to make any significant repurchases in 2009. You are asked to consent to the purchase by the company of up to a maximum of 518,836,153 Ordinary shares, which, as at 24th February 2009 being the last practicable date prior to the publication of this Notice, represented just less than 10% of the company’s issued share capital (excluding treasury shares). This authority will expire at the end of the next AGM or, if earlier, on 30th June 2010. The maximum price which may be paid for an Ordinary share will be the higher of (i) 105% of the average middle market quotations for the five business days preceding the purchase and (ii) the higher of the price of the last independent trade and the highest current independent bid at the time the purchase is carried out. The minimum price which may be paid for an Ordinary share is its nominal value of 25p. The company may either retain any of its own shares which it has purchased as treasury shares with a view to possible re-issue at a future date, or cancel them. The company would consider holding any of its own shares that it purchases pursuant to the authority conferred by this resolution as treasury shares. This would give the company the ability to re-issue treasury shares quickly and cost-effectively, and would provide the company with additional flexibility in the management of its capital base. The total number of options over Ordinary shares outstanding as at 24th February 2009, being the last practicable date prior to the publication of this Notice, was approximately 319 million representing approximately 6.15% of the issued share capital (excluding treasury shares). If the authority to buy back shares under this resolution were exercised in full, the total number of options to subscribe for Ordinary shares outstanding as at 24th February 12
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2009 would, assuming no further Ordinary shares are issued, represent 6.83% of the issued share capital (excluding treasury shares). The total number of options as set out above includes options granted by the company and legacy companies, Glaxo Wellcome plc and SmithKline Beecham plc. The obligations of the company in respect of Ordinary shares issuable under options outstanding are partly hedged by Ordinary shares held by the Group’s employee share ownership trusts, details of which can be found in the 2008 Annual Report which is available on the company’s website at www.gsk.com. The company’s current intention is to satisfy the exercise of outstanding options over approximately 90 million Ordinary shares, representing approximately 1.74% of the issued share capital of the company (excluding treasury shares), by the release of Ordinary shares from the Group’s employee share ownership trusts, which on 24th February 2009 held approximately 157 million Ordinary shares, and the remainder by the issue of new Ordinary shares.
Resolution 14 – Exemption from statement of the name of the senior statutory auditor in published copies of the Auditors’ reports (Ordinary resolution) For financial years beginning on or after 6th April 2008, every copy of the Auditors’ reports to the company’s shareholders on the Annual Report and other auditable reports that is or are published by or on behalf of the company must state, where the company’s Auditors are a firm, the name of the person who signed them in his or her own name as senior statutory auditor in relation to the audit, for and on behalf of the Auditors. However, the 2006 Act provides an exemption from this requirement if the company considers on reasonable grounds that statement of the individual’s name would create or be likely to create a serious risk that they or any other person would be subject to violence or intimidation. For many years, the company and its legacy companies, together with its employees, have been the focus of protests by various animal protection groups, some of which have engaged in aggressive, abusive and hostile acts. The Directors therefore believe that it is appropriate that the company should seek to utilise the confidentiality afforded to the senior statutory auditor of the company’s Auditors under the new legislation. This resolution therefore seeks shareholder approval for the Auditors’ reports for the financial year ending 31st December 2009 to omit the name of the senior statutory auditor. The company would give notice to the Secretary of State in the appropriate format if this resolution is passed. Resolution 15 – Reduced notice of a general meeting other than an annual general meeting (Special resolution) This resolution seeks shareholder approval to continue to be able to call general meetings other than AGMs on not less than 14 days’ notice as currently permitted under the 2006 Act. The UK Government is proposing to bring into force on 3rd August 2009 regulations to implement the EU Shareholder Rights Directive (the “Directive”) on the exercise of certain rights of shareholders in listed companies. The regulations implementing the Directive will require that listed companies provide 21 days’ notice of a general meeting. However, the UK Government will be taking advantage of an option within the Directive, which will allow companies to retain a 14 clear days’ notice period for calling a general meeting (other than an AGM, which must continue to be called on notice of at least 21 clear days) if two conditions are met. These are (a) that shareholders have, at the immediately preceding AGM or at a general meeting held since the immediately preceding AGM, passed a resolution to approve the holding of general meetings on not less than 14 clear days’ notice; and (b) that the company offers the facility for shareholders to vote by electronic means accessible to all shareholders. 13
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The Government has indicated that companies can pass the type of resolution referred to at (a) above in advance of the regulations being finalised, in order to be able to continue, after August 2009, to take advantage of the shorter notice period once the regulations come into force, subject to meeting the requirements for electronic voting under the Directive. The Government has recommended that companies seeking to propose this resolution in advance of the regulations being finalised should consider doing so as a special resolution. If approved, Resolution 15 will enable the company to retain maximum flexibility to seek shareholder approval for any future change or transaction that may require such approval. The approval will be effective until the company’s next AGM, when it is intended that a similar resolution will be proposed.
Resolutions 16, 17 and 18 – Approval of the adoption of the GlaxoSmithKline 2009 Performance Share Plan, the GlaxoSmithKline 2009 Share Option Plan and the GlaxoSmithKline 2009 Deferred Annual Bonus Plan (Ordinary resolutions) Shareholders are asked to approve the adoption of the rules of the GlaxoSmithKline 2009 Performance Share Plan, the GlaxoSmithKline 2009 Share Option Plan and the GlaxoSmithKline 2009 Deferred Annual Bonus Plan, (together, the “Plans”) to replace the company’s existing plans which expire in 2010. These plans have been designed to deliver the new Remuneration Policy which is set out in the company’s Annual Report. The principal terms of the Plans are set out on the next pages. 1
Common features The following features are common to the Plans.
1.1 Operation The company’s Remuneration Committee is responsible for granting awards to and operating the Plans with regard to Executive Directors and Corporate Executive Team members (together, the “Executives”). The Board, or a duly authorised committee of the Board (which may be the Remuneration Committee), is responsible for granting awards to and operating the Plans with regard to all other employees. 1.2 Eligibility Employees and Executive Directors of the company and any subsidiaries of the company (as designated by the Directors) are eligible to participate in the Plans. 1.3 Timing of operation Awards will normally be granted under the Plans within 42 days of the announcement of the company’s results for any period but may be granted at other times if the Remuneration Committee considers the circumstances to be exceptional. However, at all times the grant of awards will be subject to the terms of the Model Code for transactions in securities by Directors and the company’s share dealing code. Subject to shareholder approval, the first awards under the GlaxoSmithKline 2009 Performance Share Plan are expected to be granted shortly after the adoption of the Plans at the AGM. 1.4 Grant of awards Awards may be satisfied with newly issued shares, treasury shares or shares purchased in the market in conjunction with an employee benefit trust established by the company. At the discretion of the Remuneration Committee, awards may be granted subject to the participant agreeing to satisfy the employer’s social security liabilities arising on the award.
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1.5 Dilution limits In any 10 year period, not more than 10% of the issued ordinary share capital of the company may be issued or issuable under the Plans and all other employee share plans adopted by the company. In addition, in any 10 year period, not more than 5% of the issued ordinary share capital of the company may be issued or issuable under the Plans and all other discretionary employee share plans adopted by the company. These limits do not include awards and options which have lapsed or been surrendered. So long as this is required under the guidelines of the Association of British Insurers’ Investment Committee, the company will include in this calculation any treasury shares used to satisfy awards and options granted under the Plans. 1.6 Variation in share capital Awards may be adjusted at the discretion of the Remuneration Committee following any rights issue, special dividend, de-merger, consolidation, sub-division, reduction or other variation in the share capital of the company. 1.7 Issue of shares Any shares issued under the Plans will rank equally with shares of the same class in issue on the date of allotment except in respect of rights arising by reference to a prior record date. 1.8 Amendments The Remuneration Committee may amend the Plans as it considers appropriate. However, shareholder approval will be required to amend certain provisions to the advantage of participants. These provisions relate to: eligibility, individual and plan limits, adjustment of awards on a variation in the company’s share capital and the amendment powers. Shareholder approval is not required for changes that are minor in nature or for changes intended to benefit the administration of the Plans, or to comply with or take account of existing or proposed legislation or any changes in legislation or to secure favourable tax treatment for the company, members of its group or participants. 1.9 Other features Awards granted under the Plans are not pensionable and are not generally transferable (except in the case of death). 1.10 Termination The Plans may be terminated by the Remuneration Committee at any time. Awards may not be granted after the tenth anniversary of the approval of the Plans by shareholders. 1.11 Forfeiture The Remuneration Committee may reduce grant levels or outstanding awards or options granted under the Plans that have not yet vested or been exercised (with the exception of Invested Shares granted under the Deferred Annual Bonus Plan), if it is determined that a participant has engaged in conduct which is contrary to the legitimate expectations of the company for an employee in the participant’s position.
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GlaxoSmithKline 2009 Performance Share Plan
2.1 Outline The Remuneration Committee may grant conditional share awards or nil-cost options to selected eligible employees (“Awards”). 2.2 Individual limits The aggregate value (at the time of the grant) of shares subject to all Awards granted to a participant under this plan in any year will not exceed 6 times the participant’s base salary, except in exceptional circumstances. The value of the Awards to be granted to the Chief Executive Officer in 2009 will be 5 times his base salary. In applying the plan limit, no account will be taken of shares representing notional dividends on Awards or shares which have been awarded to ensure that a participant is not financially disadvantaged if he or she agrees to satisfy the employer’s social security liability in relation to his or her Award. 2.3 Performance condition The Remuneration Committee will set performance conditions annually, which must normally be satisfied before an Award can vest. For Executives, the performance conditions will normally be measured over a period of at least three financial years. The Remuneration Committee may change a performance condition if there is a situation which causes it to consider that the changed performance condition would be a fairer measure of performance. The performance conditions for Awards granted to Executives in 2009 will be based on relative Total Shareholder Return (“TSR”) over three financial years as to 30% of the Award, TSR over four financial years as to 30% of the Award and free cash flow targets as to 40% of the Award over three financial years. The performance period for Awards granted in 2009 will begin on 1st January 2009. For the Awards made in 2009, TSR performance will be measured by comparing the TSR achieved by the company with that of a comparator group currently comprising the following 12 global pharmaceutical companies: Abbott Laboratories, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Merck, Novartis, Pfizer, Roche Holdings, Sanofi-Aventis, Schering-Plough and Wyeth. Awards will not vest if the company’s TSR performance is below median. If the company’s TSR performance is median, 30% of the Award will vest, with full vesting for upper quartile performance. Between these levels, Awards will vest proportionally. If the free cash flow threshold is met, 25% of the Award will vest, with full vesting if the threshold is exceeded by the margin specified by the Remuneration Committee. Between these points, vesting will increase on a pro rata basis. If the threshold target is not met, no portion of the Award subject to free cash flow will vest. The free cash flow targets may be adjusted for material factors, which could distort free cash flow as a performance measure. These will typically include exchange rate movements and may include legal and major taxation settlements and special pension contributions, which could materially distort this calculation in either direction. The impact of any acquisition or divestment will be quantified and adjusted for at the time of the event. It is the Remuneration Committee’s intention to disclose the targets for each Award in the announcement to the London Stock Exchange at the time the Award is made. For the Awards in 2009, the threshold free cash flow target will be £13.5 billion, with maximum vesting for £16 billion.
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2.4 Acquisition of shares A participant will normally only acquire the shares subject to Awards to the extent that the performance conditions have been satisfied and provided that the participant remains in employment. When shares are acquired, the participant may also receive additional shares (or an equal cash amount) which reflect reinvested dividends that would have been paid on the vested portion of the Award during the performance period. 2.5 Leaving employment If an Executive leaves employment due to retirement or redundancy, Awards will normally vest on the original vesting date, subject to the satisfaction of the performance condition over the original period. Any Awards granted within 12 months of cessation will lapse on the date of cessation. The Committee may determine that any unvested Awards should lapse immediately, if the participant takes up employment with a competitor company during the performance period. Alternatively, the Remuneration Committee may decide that on retirement or redundancy, Executives’ Awards will vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking account of performance to that point. In this case, the Committee may also adjust the number of shares which may be acquired to take account of the time the Executive was employed during the performance period. If an Executive leaves employment due to death, ill-health, injury or disability, or the sale or transfer of the participant’s employing business, Awards will vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking into account performance to that time. The Committee may also adjust the number of shares which may be acquired to take account of the time the Executive was employed during the performance period. Awards held by participants other than Executives who leave due to retirement or redundancy will normally vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking into account performance to that time. The Committee may also adjust the number of shares which may be acquired to take account of the time the participant was employed during the performance period. Awards held by participants other than Executives who leave due to death, ill-health, injury or disability, or the sale or transfer of the participant’s employing business will vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking into account performance to that time. The Committee may also adjust the number of shares which may be acquired to take account of the time the participant was employed during the performance period. If any participant (Executive or otherwise) leaves employment for any other reason, Awards will normally lapse. 2.6 Change of control, de-merger or other reorganisations Generally, Awards will vest on a change of control taking into account performance to that point. Unless the Remuneration Committee decides otherwise, the number of shares which may be acquired will also be reduced to take account of the time the participant was employed during the performance period.
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The Remuneration Committee has the discretion to allow or require rollover of Awards on a change of control or other corporate reorganisation. The new Awards will be subject to appropriate performance conditions. On a de-merger, if the Remuneration Committee so decides, Awards may be adjusted or allowed to vest. 3
GlaxoSmithKline 2009 Share Option Plan
3.1 Outline Selected eligible employees may be granted market value options (“Options”) over the company’s shares or equity-settled Stock Appreciation Rights. The Option price will not be less than the market value of a share on the business day before the date of grant or the average market value over the three preceding business days. 3.2 Individual limits Where a participant receives Options under the company’s 2009 Share Option Plan and Awards under the company’s 2009 Performance Share Plan in any year, it is currently intended that the expected value of Options granted to him or her in that year will not exceed 60% of the aggregate expected value of Options and Performance Share Plan Awards granted to him or her in that year. In applying this limit, no account will be taken of shares which have been awarded to ensure that a participant is not financially disadvantaged if he or she agrees to satisfy the employer’s social security liability in relation to the Options. Where a participant is not granted Awards under the company’s 2009 Performance Share Plan, the annual Share Option Plan limit will be calculated on an equivalent basis to that which applies to the company’s 2009 Performance Share Plan. It is the current intention that Options will not be granted to the Chief Executive Officer or Chief Financial Officer. 3.3 Performance condition The Remuneration Committee may, and for Executives will, set a performance condition annually, and any such performance condition imposed must normally be satisfied before the exercise of an Option. The performance condition will normally be measured over a period of at least three financial years. In line with previous option grants, the performance condition for any Options granted to Executives in 2009 is based on the company’s Earnings Per Share (“EPS”) relative to the Retail Prices Index (“RPI”). Options will not vest if compound EPS growth is less than RPI plus 3% per annum. If compound EPS growth is RPI plus 3% per annum Options will vest as to 30%, if it is RPI plus 4%, they will vest as to 65% and if it is RPI plus 5%, they will vest as to 85%. Full vesting will occur if compound EPS growth is at least RPI plus 6% per annum. In between these levels, Options will vest on a pro rata basis. The performance period for Options granted in 2009 to Executives will begin on 1st January 2009 and will be three financial years in respect of 50% of the award and four financial years in respect of the remaining 50% of the award. 3.4 Exercise of Options Options will normally vest (become exercisable) no less than three years following the date of grant, subject to any performance condition being satisfied and to the participant remaining in employment. In respect of the Options granted to Executives in 2009, subject to performance and remaining in employment, 50% of the Options will vest following the determination of the satisfaction of the performance condition over three financial years by the 18
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Remuneration Committee and the remaining 50% following the determination of the performance condition over four financial years. Options will normally lapse on the tenth anniversary of the grant date. 3.5 Leaving employment If an Executive leaves employment due to retirement or redundancy, Options will normally vest on the original vesting date, subject to the satisfaction of the performance condition over the original period. The Remuneration Committee may determine that any Options granted within 12 months of cessation will lapse on the date of cessation. The Committee may also determine that unvested Options will lapse immediately if the participant takes up employment with a competitor company prior to vesting. Alternatively, the Remuneration Committee may decide on retirement or redundancy, that Options for Executives will vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking into account performance to that point. If an Executive leaves employment due to death, ill-health, injury, disability or due to a sale or transfer of the participant’s employing business, Options will vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking into account performance to that point. Options held by participants other than Executives who leave for any of the reasons described above will normally vest at the end of the financial year in which the cessation occurred or at such earlier point that the Remuneration Committee decides at its discretion. In all leaver circumstances described above, vested Options may be exercised up to the later of 48 months from grant, 24 months from the cessation of employment and six months from the normal vesting date (apart from on death, in which case they will be exercisable for 12 months from the date of death). If not exercised within the specified period, the Options will lapse. If any participant (Executive or otherwise) leaves employment for any other reason, unvested Options will normally lapse. 3.6 Change of control, de-merger or other reorganisations Generally, Options will vest on a change of control taking into account performance to that point, and the level of vesting may be adjusted if the Remuneration Committee considers it appropriate. Vested Options may be exercised for six weeks and if not exercised within this period, the Options will lapse. The Remuneration Committee has the discretion to allow or require rollover of Options on a change of control or other corporate reorganisation. The new Options will be subject to equivalent performance conditions, if any. On a de-merger, if the Remuneration Committee so decides, Options may be adjusted or allowed to vest. 4 GlaxoSmithKline 2009 Deferred Annual Bonus Plan 4.1 Outline Selected eligible employees may be invited to invest an element of their pre-tax or net annual bonus in the company’s shares (“Invested Shares”). Participants will then be granted an award of matching shares (“Matching Shares”). Such awards may take the form of a conditional share award or a nil-cost option (or other forms with 19
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an economically equivalent value). The receipt of Matching Shares is normally subject to the satisfaction of a performance condition, continued employment and the continued holding of the Invested Shares until the point when the Matching Shares vest. Executives who did not receive option grants in 2009 will be invited to invest up to 50% of their pre-tax or net annual bonus in the plan. 4.2 Individual limits Matching Shares will be calculated on the basis of a maximum of one share for each share invested by the participant (determined on a pre-tax basis). 4.3 Performance condition The Remuneration Committee will set a performance condition for the Matching Shares which must normally be satisfied before Matching Shares can vest. The performance condition will be measured over a period of at least three financial years. The performance condition for Matching Shares granted in respect of the 2009 bonus will be based on TSR, and will be the same as the TSR performance condition for PSP Awards, as described on page 16 above. The TSR performance condition for all Matching Shares will be measured over three financial years. 4.4 Acquisition of shares A participant will only acquire the Matching Shares if they vest, to the extent that the performance condition has been satisfied and provided that the participant remains in employment for that period. On release, the participant will also receive shares or a cash amount with a value equal to reinvested dividends that would have been paid on those shares during the performance period. Invested Shares will be released at the end of the performance period. 4.5 Leaving employment Invested Shares will be released when a participant is no longer eligible to receive Matching Shares in respect of those Invested Shares, whatever the reason. Matching Shares held by leavers will be treated as described on page 17 in relation to Awards granted under the company’s 2009 Performance Share Plan. 4.6 Change of control, de-merger or other reorganisations Invested Shares will be released on a change of control unless Matching Shares are exchanged as described below. Generally, Matching Shares will vest on a change of control taking into account performance to that point. Unless the Remuneration Committee decides otherwise, the number of shares which may be acquired will also be reduced to take account of the time the Executive was employed during the performance period. The Remuneration Committee has the discretion to allow or require rollover of Matching Shares on a change of control or other corporate reorganisation. The new Matching Shares will be subject to equivalent performance conditions, if any. On a de-merger, if the Remuneration Committee so decides, Matching Shares may be adjusted or allowed to vest. In this case, Invested Shares will not be released but will be exchanged for shares in the acquiring company.
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Issued share capital All references to the company’s ‘issued share capital’ in the Explanatory Notes above are to the company’s issued share capital as at 24th February 2009, which was 5,188,361,535 Ordinary shares, excluding any Ordinary shares held as treasury shares. As at 24th February 2009, the company held 474,194,158 Ordinary shares as treasury shares, representing 9.14% of the company’s issued share capital (excluding treasury shares) as at that date. As at 24th February 2009, the total number of voting rights in the company was 5,188,361,535. The following information is provided in respect of section 992 Companies Act 2006: Share capital and control As at 31st December 2008, the company’s authorised share capital comprised £2,500,000,000, divided into 10,000,000,000 Ordinary shares of 25p each nominal value, representing 100% of the total authorised share capital. On 31st December 2008 there were 5,187,122,079 Ordinary shares in issue, excluding 474,194,158 treasury shares (which represented 9.14% of the total issued capital). GSK’s shares are listed on the London Stock Exchange and are also quoted on the New York Stock Exchange in the form of American Depositary shares (“ADSs”). Each ADS represents two Ordinary shares. The holders of Ordinary shares are entitled to receive dividends, when declared, the company’s report and accounts, to attend and speak at General Meetings of the company, to appoint proxies and to exercise voting rights. There are no restrictions on transfer, or limitations on the holding of Ordinary shares and no requirements to obtain prior approval to any transfers. No Ordinary shares carry any special rights with regard to control of the company and there are no restrictions on voting rights. Major shareholders have the same voting rights per share as all other shareholders. There are no known arrangements under which financial rights are held by a person other than the holder of the shares and no known agreements or restrictions on share transfers or on voting rights. Shares acquired through GSK share schemes and plans rank equally with the other shares in issue and have no special rights. The trustees of the company’s Employee Share Ownership Plan (“ESOP”) trusts have waived their rights to dividends on shares held by the ESOP trusts.
Change of control The company is not party to any significant agreements that would take effect, alter or terminate upon a change of control following a takeover bid. The company does not have agreements with any Director or Officer that would provide compensation for loss of office or employment resulting from a takeover, except that provisions of the company’s share plans may cause options and awards granted under such plans to vest on a takeover.
Interests in voting rights Other than as stated below, as far as the company is aware, there are no persons with significant direct or indirect holdings in the company. Information provided to the company pursuant to the Financial Services Authority’s (“FSA”) Disclosure and Transparency Rules (“DTRs”) is published on a Regulatory Information Service and on the company’s website.
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At 24th February 2009, the company had received notifications in accordance with the FSA’s DTRs of the following notifiable interests, in the voting rights in the company’s issued share capital: No. of Percentage of issued shares capital (%)* Barclays PLC 186,518,653 3.59 * Percentage of Ordinary shares in issue, excluding treasury shares as at 24th February 2009.
The Bank of New York Mellon is the Depositary for the company’s ADRs, which are listed on the New York Stock Exchange. Ordinary shares representing the company’s ADR program, which are managed by the Depositary, are registered in the name of BNY (Nominees) Limited. The company has not acquired or disposed of any interests in its own shares, other than in connection with the company’s share buy-back programme. Details of the shares purchased, cancelled and held in treasury are given in the Annual Report.
Directors and Officers The interests of Directors and Officers and their connected persons in the issued share capital of the company are given in the Annual Report. The rules about the appointment and replacement of Directors are contained in the company’s Articles of Association. The company’s Articles must be approved by shareholders in accordance with the legislation in force from time to time. The Articles provide that Directors may be appointed by an ordinary resolution of the members or by a resolution of the Directors, provided that, in the latter instance, a Director appointed in this way retires at the first AGM following his appointment. The Articles also require that at every AGM certain of our current Directors retire by rotation, and detail the circumstances in which and how they may be re-elected. The company’s members may remove a Director by passing an ordinary resolution of which special notice has been given. A Director will automatically cease to be a Director if (i) he becomes bankrupt or compounds with his creditors generally, (ii) he is or has been suffering from mental ill health and the Board resolves that his office is vacated, (iii) he has missed Directors’ meetings for a continuous period of six months without permission and the Board resolves that he shall cease to be a Director, (iv) he is prohibited from being a Director by law, (v) he ceases to be a Director by virtue of UK companies legislation or is removed from office pursuant to the company’s Articles of Association, (vi) he resigns, (vii) he offers to resign and the Board accepts that offer, or (viii) his resignation is requested by all of the other Directors and all of the other Directors are not less than three in number. The company’s Articles may be amended by a special resolution of the members. The powers of the Directors are determined by UK legislation and the company’s Memorandum and Articles of Association, available on www.gsk.com. As provided in those Articles, the Directors may exercise all the company’s powers provided that the Articles or applicable legislation do not stipulate that any such powers must be exercised by the members. The Directors have been authorised to issue and allot Ordinary shares, and have authority to make market purchases of shares. Renewal of these authorities is sought from shareholders at each AGM. Any shares purchased may be cancelled or held as treasury shares.
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Appendix E: 2009 Notice of Annual GlaxoSmithKline Shareholder Meeting
GlaxoSmithKline Information on how to vote Voting using Shareview If you have a Shareview portfolio, you may register your vote electronically by visiting www.shareview.co.uk, logging into your account and following the instructions provided. Voting using Sharevote You may register your vote electronically by visiting www.sharevote.co.uk and following the instructions provided. Voting using CREST’s electronic proxy appointment service If you hold your shares in uncertificated form in CREST you may use the electronic proxy appointment service operated by CREST to appoint a proxy and register your vote. CREST members who wish to appoint a proxy or proxies by utilising the CREST electronic proxy appointment service may do so for the AGM to be held on Wednesday, 20th May 2009 and any adjournment(s) thereof by utilising the procedures described in the CREST Manual. CREST Personal Members or other CREST sponsored members, and those CREST members who have appointed a voting service provider(s), should refer to their CREST sponsor or voting service provider(s), who will be able to take the appropriate action on their behalf. In order for a proxy appointment or instruction made using the CREST service to be valid, the appropriate CREST message (a “CREST Proxy Instruction”) must be properly authenticated in accordance with Euroclear’s specifications and must contain the information required for such instructions, as described in the CREST Manual. The message, regardless of whether it constitutes the appointment of a proxy or an instruction to a previously appointed proxy, must be transmitted so as to be received by the issuer’s agent, Equiniti ID RA19 by 2.30pm on Monday, 18th May 2009 in order to be valid. For this purpose, the time of receipt will be taken to be the time (as determined by the timestamp applied to the message by the CREST Applications Host) from which the issuer’s agent is able to retrieve the message by enquiry to CREST in the manner prescribed by CREST. After this time any change of instructions to proxies appointed through CREST should be communicated to the appointee through other means. CREST members and, where applicable, their CREST sponsors or voting service providers should note that Euroclear does not make available special procedures in CREST for any particular messages. Normal system timings and limitations will therefore apply in relation to the input of CREST Proxy Instructions. It is the responsibility of the CREST member concerned to take (or, if the CREST member is a CREST Personal Member or sponsored member or has appointed (a) voting service provider(s), to procure that his CREST sponsor or voting service provider(s) take(s)) such action as shall be necessary to ensure that a message is transmitted by means of the CREST system by any particular time. In this connection, CREST members and, where applicable, their CREST sponsors or voting service providers are referred, in particular, to those sections of the CREST Manual concerning practical limitations of the CREST system and timings. The company may treat as invalid a CREST Proxy Instruction in the circumstances set out in Regulation 35(5)(a) of the Uncertificated Securities Regulations 2001.
23
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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Appendix E: 2009 Notice of Annual GlaxoSmithKline Shareholder Meeting
GlaxoSmithKline plc 980 Great West Road Brentford Middlesex TW8 9GS
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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Appendix F: Access to Medicine Index Report
GlaxoSmithKline
Company Profile
Ticker: GSKLN
2007 Revenues:
GlaxoSmithKline
UK
USD 44,640 million 32% of revenues are generated in Europe, 45% in the US and 23% in the rest of the world. TB: In collaboration with TB Alliance: Bacterial Topoisomerase (lead optimized), Pleuromutilins (lead optimized), inhA Inhibitors (lead identified), antimicrobial screening program (discovery). In collaboration with Aeras Global TB vaccine Foundation: vaccine (Mtb72F/AS02A) in phase 1.
Product Pipeline For Neglected Diseases
Malaria: In collaboration with MMV: 1. n-tert butyl isoquine GSK 369796 (preclinical) 2. 4(1H) pyridones back-ups (Preclinical) 3. Falcipains (Cysteine Protease) (lead optimized) 4. Fatty Avid Bionsynthesis (lead optimized) In collaboration with W Reed: Tafenoquine/etaquine (phase 3) The company itself: Antimicrobial Screening Program (discovery) + Vaccine with the Malaria Vaccine Initiative: RTS, S/AS02A ( phase 3) Chagas disease, human African trypanosomiasis and Leishmaniasis in collaboration with DNDi Leishmaniasis: the company itself: Sitamaquine (WR6026) (phase 2b) Dengue: Vaccine (phase2) in collaboration with Pediatric Dengue Vaccine Initiative
Existing Commercial Products:
Company Rank
HIV, Malaria, Respiratory, Central nervous system , Metabolic Oncology and emesis, Cardiovascular and urogenital, Skin disease, Arthritis, Gastrointestinal Vaccine: Cervical cancer, Chickenpox, Diphtheria, Hepatitis A and B, Influenza, Measles, Meningitis, Mumps, Polio, Rotavirus, Rubella, Tetanus, Typhoid, Whooping cough (Pertussis), Pneumonia, otitis media and bacterial meningitis
1
Company Score
4.53
1 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
Management Influence R&D Patenting Capacity Pricing Drug donations Philanthropy
0
1
2
3
4
5
2 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
A. Access to Medicines Management (20%) Weight
Indicators
Scores
A1. Governance: The company has a governance system that includes direct board level responsibility and accountability for its ATMs strategy. A2. Policy and Disclosure: The company has a public global policy in place, in which it explains its rationale for ATMs, its contents and details its specific objectives.
5
A3. Systems and Reporting: The company has a management system, including quantitative targets, to implement, monitor and report on its ATMs strategy.
5
25%
25%
A4. Stakeholder Input: The company has a mechanism for stakeholder engagement which inputs into ATMs management.
5
A5. The company has globally applicable ethical business practices and marketing policies that conform to appropriate standards.
5
10%
20%
20%
Company Rank
Comment
1
Company Score
5
5
GSK is a clear leader in access to medicines (ATMs). The group has a global ATMs policy that is governed through a clear management system, with accountability at the board level. GSK has a wide range of relevant ATMs programs including R&D investment into neglected diseases and the global disease burden, an equitable pricing policy, voluntary licensing, drug donations and philanthropic activities. GSK articulates the business case for ATMs mentioning "ethical, reputational and commercial reasons" for addressing the ATMs issue. In particular, GSK considers that addressing ATMs issues will help attract and retain highly skilled employees, maintain the intellectual property rights system, and secure long-term business opportunities in the developing world. GSK's reporting is very detailed. The company clearly states its long-term objectives and has defined a wide range of relevant key performance indicators to measure the impact of its activities and report on progress. GSK also relies on a third party to certify the accuracy of the information disclosed in the CSR report and that the ATMs section addresses the material aspects of ATMs as expected by GSK's stakeholders. Regarding stakeholder involvement, GSK maintains regular communication with relevant stakeholders on ATMs issues, and in particular in 2007 the discussions focused on R&D for neglected diseases, improving access to HIV drugs and improving access in middle-income countries. The "Tearing Down the Barriers" concept is a clear example of how stakeholders input into the company ATMs strategy (see equitable pricing for more details on this concept). GSK uses various means to communicate internally on ATMs. While the company has not come up with an indicator to measure the impact of its ATMs approach on employee morale, GSK recognizes its value. When interviewed by Innovest, the company mentioned that when traveling around the company the new CEO informally asked employees what they like about GSK and their first response was the commitment towards the developing world including R&D programs, pricing approaches, and community involvement.
3 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
B. Public Policy Influence & Advocacy (10%) Weight
5%
20%
20%
40%
15% Company Rank
Comment
Indicators
Scores
B1. The company has a position on public policy advocacy and transparency.
5
B2. The company and subsidiaries disclose major public policy positions at regional, national and international levels related to the ATMs debate. B3. The company and subsidiaries actively advocate health reforms that foster ATMs and policies that would result in improvements in public health.
5
B4. The company annually discloses which individuals, patient associations, political parties, trade associations and academic departments it supports with which it might advocate on public policy positions and practices; at a regional, national and international level. B5. The company demonstrates a process of board approval of the approach to public policy advocacy, its transparency and reporting.
4
2
Company Score
5
5
4.6
GSK recognizes stakeholders’ concerns about lobbying by pharmaceutical companies and therefore issues a clear commitment towards transparency in public policy advocacy and lobbying. Like its peers, GSK lobbies policy makers and stakeholders to shape public health policy and ATMs. However, compared to its peers in the sector, GSK discloses information on advocacy activities undertaken by the company in 2007. It mentions examples like urging the G8 to continue making healthcare in the developing world a major agenda item, working with UK Department for International Development (DFID) on its Medicines Transparency Alliance (MeTA), providing evidence to the EU Parliament’s Committee on International Trade to encourage ratification of the WTO compulsory licensing for export protocol etc. GSK also states its position on major ATMs debates like the issuance of compulsory licenses by the Thai government or the intellectual property (IP) system in India. GSK recognizes that compulsory licenses are a legitimate option but calls for more dialogue with the Thai government before a license is issued. As for India, GSK thinks that developing an IP system similar to the European or American standards would help foster innovation to the benefit of patients and the Indian economy as a whole. GSK adds that it is working on an equitable pricing policy to help facilitate ATMs to those in need in India; however, the company maintains that poverty and a lack of healthcare infrastructure are the main barriers, not prices. Additionally, advocacy is a key component of several of the company's community programs, notably malaria and Lymphatic Filariasis (LF). Regarding industry associations, GSK is a member of several industry organizations, but the company states that it will not participate in advocacy activity, if it disagrees with industry positions. Commendably, GSK also mentions examples of positions it wants to pursue within the industry and in particular a code of good practices on relationships with patient organizations. GSK has set more stringent standards for itself with regards to patient organizations and was the first European company in 2007 to publish information on all its work with European patient groups including details of the funding received. In 2008, GSK extended the scope of disclosure to include international support.
4 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline GSK also complies with legal requirements to report on lobbying expenses and it spent USD 8.24 million in federal lobbying activities in the US during 2007. Lastly, GSK has developed an Employee Guide to Business Conduct which commits employees to acting with honesty and integrity in their lobbying activities. A Corporate Executive Team reviews the company's advocacy activities.
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
C. R&D that Reflects both the Global Disease Burden and Neglected Diseases (20%) Weight
Indicators
5%
C1. The company has a policy on R&D investment that reflects both the global disease burden and neglected diseases.
5
C2. The company provides evidence of in-house investment in R&D into new treatments for neglected diseases.
5
30%
C3. The company with in-house investment in R&D into new treatments for neglected diseases provides evidence of partnership with groups with developing-country health expertise, such as product development public-private partnerships, academic institutions and/or the World Health Organization.
5
C4. The company shows temporal evidence that its research programs into both the global disease burden and neglected diseases consider research into existing medicines and formulations suitable for use in developing and least developed countries and for affected patient groups.
5
40%
25%
Company Rank
Comment
1
Company Score
Scores
5
GSK is a leader in R&D for neglected diseases. The company is involved in R&D for new treatments for malaria, TB, leishmaniasis, sleeping sickness and Chagas disease and is investing in vaccines for AIDS, TB, dengue fever and Malaria. A third of its vaccine pipeline is for diseases of the developing world. In 2008, GSK had 12 ongoing clinical programs, seven of which were focused on neglected diseases. The company has both in-house and collaborative R&D. GSK has a dedicated site called, The Diseases of the Developing World Drug Discovery Centre at Tres Cantos. The R&D center employs 105 scientists that are solely dedicated to the discovery of new medicines for neglected diseases with a special focus on malaria and TB. The TB Alliance supports 25 full-time scientists at Tres Cantos, while GSK contributes a matching number of staff and remaining overhead costs. The Medicines for Malaria Venture (MMV) is subsidizing 30 scientists at the Tres Cantos facility and also provides input from its expert scientific Advisory committee. A similar group exists in the vaccines organization based in Belgium. GSK does not expect to make profit on new treatments for neglected diseases and therefore works in partnerships to share the R&D costs and ensure affordable prices of new treatments for poor patients in the developing world. In the area of TB, GSK and the TB Alliance announced the renewal of their partnerships for drug discovery in 2008. GSK is also collaborating with the Aeras Global TB Vaccine Foundation to develop a candidate vaccine against TB. In the area of malaria, GSK is partnering with MMV on new treatments and is internally working on a candidate malaria vaccine for children, which is in phase 2 clinical trial in Africa. In the area of leishmaniasis, sleeping sickness and Chagas disease, GSK has recently entered into a partnership with DNDi. GSK is also funding the development of a new once-a-day oral treatment for visceral leishmaniasis. This example clearly reflects GSK's commitment to considering developing country context when researching on a new treatment. GSK emphasizes factors such as heat and humidity and easy to use to ensure appropriate use in the developing world. GSK has been working on a malaria vaccine for over 20 years and have invested over USD300 million to date. A pivotal Phase III trial is now planned, which, if successful, could result in submission to regulatory authorities in 2011. 6
© Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
D. Patents & Licensing (10%) Weight
60%
40%
Company Rank
Comment
Indicators
Scores
D1. The company demonstrates the existence of, and discloses the terms of, non-exclusive voluntary license agreements to increase ATMs in developing countries.
5
D2. The company publicly commits itself to respecting the right of developing countries to use the provisions in the TRIPS agreement.
2
1
Company Score
3.8
Like its peers, GSK considers that intellectual property rights are essential to boost innovation and are not barriers to ATMs. Commendably, GSK demonstrates its willingness to use pathways to protect its discoveries while improving access to its HIV drugs. Since 2001, the company has entered into eight voluntary licenses with local companies in Africa. These practices are successful as licensees supplied 183 million tablets of their versions of Epivir and Combivir to Africa in 2007. This represents a more than 50% growth over 2006. GSK also granted a voluntary license to Simcere, a Chinese manufacturer, giving it the right to manufacture and sell zanamivir, an antiviral for the treatment of flu, in China, and to sell in a number of other countries including all 50 of the least-developed countries (LDCs). In August 2007, GSK also agreed to enable a Canadian company, Apotex, to manufacture a generic fixed-dose combination ARV, containing two molecules over which GSK has patent rights, for the treatment of HIV/AIDS in Rwanda. This practice is in line with WTO 31F agreement. GSK clearly states its position on TRIPS with regards to Thailand and India (see Public Policy Influence & Advocacy) and withdrew a patent application for Combivir in India. In 1997, GSK had applied for a patent for Combivir in India. In August 2006, this application was the subject of protests by the civil society in India, but GSK had instructed the patent application to be withdrawn in a number of countries, including India, prior to this date. However there are allegations that the company suggested that the UK government should intervene with Thailand about its compulsory licensing policy. It also certainly persuaded Peter Mandelson to write to Thailand several times about their compulsory licensing policies.
7 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
E. Drug Manufacturing, Distribution and Capability Advancement (15%) Weight
Indicators
E1. The company demonstrates efforts to manufacture drugs to the highest quality standards.
5
20%
E2. The company enters into technology transfer agreements with local companies in developing and least developed countries. E3. The company undertakes external activities to support the monitoring of drugs that reflect both the global disease burden and neglected diseases including participation in public private partnerships.
3
20%
E4. The company has mechanisms in place to help prevent product diversion and to address counterfeiting, in collaboration with states.
4
E5. The company demonstrates efforts to provide ATMs to its employees and their relatives in developing and least developed countries.
4
10%
35%
15%
Company Rank
Comment
4
Company Score
Scores
3
3.7
GSK recognizes the inadequate healthcare infrastructure in developing and leastdeveloped countries. Specifically with regard to voluntary licensing, GSK is aware of limited infrastructure and carefully selects licensees with adequate manufacturing capabilities allowing them to ensure long-term supply of good-quality drugs. However, other policies stating safeguards or measures to prevent manufacturing faults associated with poor infrastructure are not disclosed. GSK considers that drug manufacturing is the responsibility of the licensee and the local drug regulatory authority. Relating to technology transfers GSK signed a technology transfer agreement with the Brazilian government institute, Fiocruz, to produce Rotarix for the domestic market and manufacture Rotarix for GSK under contract for export to other developing countries. A similar agreement exists in Brazil for GSK's oral polio vaccine, Haemophilus influenzae type b (Hib) vaccine and measles, mumps and rubella vaccine. Additionally GSK has a drug discovery and clinical development collaboration covering a wide range of therapeutic areas with Ranbaxy in India. GSK also supports the INDOX program where they are training clinicians from 12 Indian oncology centers through collaboration with the University of Oxford. Indian clinicians spend some time at Oxford within the oncology department at the Radcliffe Hospital to supplement their online learning to bring them up to good clinical practice. GSK supports this operation through UKIERI. GSK is also proactive in improving pharmacovigilance systems in the developing world. In 2006, GSK organized a meeting on pharmacovigilance with African clinicians, African regulatory representatives and WHO representatives to identify challenges and share best practice between HIV and malaria pharmacovigilance. The company has operations in the developing world and has a policy to offer HIV drugs to all HIV positive employees and their families in countries where treatment is not available through the local healthcare system. GSK has implemented a program on HIV in the workplace, Positive Action At Work. Finally GSK has developed relevant programs to prevent product diversion and counterfeiting in collaboration with states, pharmacists, wholesalers and other pharmaceutical companies.
8 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
F. Equitable Pricing (15%) Weight
Indicators
Scores
20%
F1. The company can demonstrate efforts to register treatments that 4 reflect both the global disease burden and neglected diseases in developing and least developed countries. F2. The company has a policy to facilitate ATMs in developing and least developed countries through pricing mechanisms which include reporting on scope, pricing levels and pricing reviews.
5
50%
10%
F3. The company demonstrates that its discount schemes place the minimum administrative burden on the beneficiary health system.
5
F4. The company has a policy for the very poorest in countries with no public healthcare provision.
5
20% Company Rank
Comment
1
Company Score
4.8
GSK is committed to registering its drugs worldwide, and there is no evidence that the company is involved in registration problems. Commendably, GSK strives to speed up the registration process in the developing world by using mechanisms such as the European Medicines Agency (EMEA), Article 58. In 2007, GSK had products listed in 17 out of 27 therapeutic areas on the WHO Essential Medicines List. GSK has implemented a sound equitable pricing policy for its ARVs, anti-malarials and its vaccines. The company offers not-for-profit prices (nfp) to NGOs and the public sector in all LDCs and all of SSA and to all fully funded CCM projects of the Global Fund and to The US President's Emergency Plan for AIDS Relief (PEPFAR) projects. In SSA, GSK offers nfp to private employers who provide healthcare benefits to their uninsured staff. For middle-income countries (MIC) the company states that it will negotiate on a case-by-case basis. Since 1997 and the creation of its equitable pricing policy, GSK has decreased the price of its ARVs five times. The most recent announcement in February 2008 represented a 21% decrease on average across GSK’s ARVs pipeline. This price drop is due to improvements and efficiencies in manufacturing and supply, and reductions in the costs of active ingredients. Commendably, GSK discloses the number of drugs shipped at nfp in the developing world. The number has been reduced in 2007 due to the increase of supply by GSK's licensees (see Patents & Licensing). With regard to vaccines, for over 20 years, GSK has made its vaccine portfolio available at preferential prices to developing countries, using a tiered pricing system. Prices are linked to gross national incomes as defined by the World Bank as well as the size of an order and length of a particular supply contract. For the developing world prices can be as little as a tenth of those for developed countries. In 2007, GSK shipped 1.1 billion vaccines, 78% went to the developing world in collaboration with the WHO, GAVI, UNICEF and Pan-American Health organization. Thanks to a large volume of sales and long-term contracts, GSK has been able to reduce the price of the dose. Most noticeably, GSK is working on a concept called "Tearing Down the Barriers" to develop pricing mechanisms for private and public sector markets in MIC. The company is working on pilot projects including "tiered-pricing models within as well as between countries; a system to gauge the relationship between price and volume for selected products in targeted middle-income countries; and differential branding strategies in targeted middle-income countries." GSK is also considering pricing mechanisms for treatments for diabetes, lung cancer, cardiovascular diseases and bacterial infections as part of "Tearing Down the Barriers". Finally GSK is heavily involved in the developed world. In 2007, more than 484,000 US patients received GSK medicines worth almost USD 388 million compared with USD 370 million in 2006. GSK has also introduced discount cards in Bulgaria and Lithuania to enable poor people with chronic diseases to obtain prescription medicines at a discount price. 9
© Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
G. Drug Donations (6%) Weight
Indicators
Scores
60%
G1. The company has a policy that fully conforms to the WHO’s Guidelines for Drug Donations.
5
G2.The company discloses the absolute volume of its drug donations and, to the extent possible, the number of treatments approved for patient use per year.
5
40%
Company Rank
Comment
1
Company Score
5
GSK is committed to the development of long-term, sustainable solutions to the challenges relating to the availability of its medicines. Drug donations do not form a central component of the company's policies to increase sustainable ATMs. GSK has a drug donation policy that is in line with the WHO’s guidelines on drug donations. It recognizes that donations are relevant in emergency situation and/or as part of an eradication program. Therefore in 2007, GSK donated medicines valued at GBP 16 million to support disaster and humanitarian relief in 107 countries. In addition to donations of antibiotics and other essential medicines, as part of its partnership with the WHO's Global Alliance to Eliminate Lymphatic Filariasis, GSK has donated almost 750 million albendazole treatments since 1998. Additionally, in 2007, GSK announced its intention to donate 50 million doses of its pre-pandemic H5N1 flu vaccine to the WHO stockpile. In the event of an outbreak these can be rapidly distributed to the world’s poorest countries.
10 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
H. Philanthropic Activities (4%) Weight 100% Company Rank
Comment
Indicators
H. The company has philanthropic programs related to ATMs not covered by any of the other criteria. 9
Company Score
Scores
3 3
In 2007, GSK's philanthropic activity was valued at GBP 282 million compared with GBP 302 million in 2006. This is equivalent to 3.8% of the company's pre-tax profits (3.9% in 2006). Through its Global Community Partnerships program, GSK funds community-led initiatives in over 100 countries around the world. GSK has a wide range of philanthropic programs and partnerships with a focus on health and education programs for under-served communities, and maintains robust relationships with its partners to ensure the effectiveness and the sustainability of these programs. As mentioned in the Drug Donations section, GSK is collaborating with the WHO's Global Alliance to Eliminate Lymphatic Filariasis. In 2007, the company gave GBP 1 million to support alliance partners and has employees helping on advocacy, research and education. Through its Positive Action program founded in 1992, GSK is also working on education, capacity building and support to local organizations on HIV/AIDS in 19 countries. It is also involved in advocacy on malaria in Europe and Africa. Lastly, GSK invests significantly in diarrheal disease with programs such as PHASE – hygiene and sanitation education program now running in 12 countries. This program shows favorable results as diarrhea rates have decreased by 40% in participating schools since the introduction of PHASE to schools in Kenya.
11 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix G: GSK Public Relation Tactic 1
GSK to strip down through outsourcing and offshoring
http://www.drugresearcher.com/Research-management/GSK-to-strip-dow...
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October 2009 September 2009 Previous months
GSK to strip down through outsourcing and offshoring
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LATEST NEWS HEADLINES Small molecules still leading the way into the clinic
By Kirsty Barnes, 26-Oct-2007
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New drug target leaves lung cancer cells alone, lonely and dying
GlaxoSmithKline (GSK) is planning to strip itself down closer to the bare bones of the business through further outsourcing and offshoring, with hopes of making itself into a lean, mean, pharma machine. The pharma heavyweight announced a sweeping restructuring plan in the form of an 'Operational Excellence' programme, designed to achieve savings of up to £700m (€1bn) by 2010 - 40 per cent of which will come from cutting down on manufacturing sites and simplifying production processes and activities to reduce over capacity. The cornerstones of this new programme are "persistent focus across all functions; a reduction in complexity, to be achieved by standardisation, consolidation, outsourcing and offshoring; and the exploitation of global opportunities, in regard to procurement, skills, labour cost and arbitrage," indicated GSK's CEO Dr J.P. Garnier. As with most pharm firms in today's tough business climate, GSK has already been embracing outsourcing and offshoring to a certain extent in order to tighten its purse strings, however, as more parts of the business are seeing the fruits of this strategy, the firm is stepping up its resolve in this regard.
A drug cocktail to bust brain tumours IDM Pharma will cut jobs after Sanofi scraps melanoma collaboration
Free e-mail alerts Please indicate your area of interest and receive free alerts directly to your inbox Assays and screening Cell culture & Equipment Chromatography Compounds and consumables Contract services (outsourcing) Drug discovery
"Basically, we are good at standardising and outsourcing when it's not a core activity that we want to manage ourselves. The arbitrage that is now available through the global world in which we live is a phenomenal opportunity and we are taking full advantage," said Garnier during an analyst call covering GSK's third quarter results.
Genomics / Proteomics
"We are now in a position to basically accelerate what we've been doing all along," he said, without going into much further detail.
Liquid handling and sample preparation
Garnier highlighted the business areas the firm has already been either offshoring or doling out to third parties: clinical trials; human resources; IT, data management and shared financial services; and back-office functions. In addition, the firm has established a commercial analytics centre in India, conducted a rationalisation of its manufacturing network, and now undertakes global procurement across all functions.
Production technologies
Informatics & IT Lab equipment & consumables Separation and purification
Liquid handling and automation
Analysis and instrumentation Your email
The company's selling, general and administrative (SG&A) costs as a percentage of turnover, were 35.0 per cent in 2001, and now nine months into 2007 they sit nearly six percentage points lower at 29.4 per cent. "This is an example of those savings," said Garnier. "Even in the years where we didn't have significant growth in revenues, for instance, the year we lost Paxil and Augmentin, we were still able improve the SG&A ratio every time, and I expect this to continue in the future". In terms of manufacturing, GSK has big plans for slimming down an already shrinking in-house capability over the next three years. In 2000 GSK owned 108 manufacturing sites, by 2006 this had been cut by 28 to 80 and the firm is anticipating similar cuts by 2010. Meanwhile, in 2001 only 9 per cent of the firm's primary active pharmaceutical ingredient (API) costs were outsourced, now that figure has jumped to 41 per cent and continues to climb. "We think that over the next three years we will be able to make significant inroads, which means first of all, that the percentage of our primary cost is going to be different in three years in terms of outsourcing," said Garnier, adding that the company had in an internal target in place for this. "But, the point is that outsourcing is going to grow, particularly, when you look at the share of the multi-sourced business we are still manufacturing and we have a number of products going generic, which are now fair game for potential outsourcing. So, that's what it's all about with manufacturing, a more efficient network at the end of the day." However, GSK is only willing to relinquish control of production when it feels products are established enough to warrant outsiders picking up some of the work: "What we want is to protect our new products… We don't want anybody to have control over our new products - for commercial reasons, but also for ethical reasons. We don't want people to make our oncology products because if they go wrong [or] out of stock, we are killing people", said Garnier. As such, he indicated that the company wants to retain manufacturing control of all new products until they become multi-sourced. After that time, the firm is less bothered as to whether products are made in house or by third parties, but with Garnier's caveat that "if we can buy it cheaper than we can make it then of
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Appendix G: GSK Public Relation Tactic 1 (cont.)
GSK to strip down through outsourcing and offshoring
http://www.drugresearcher.com/Research-management/GSK-to-strip-dow...
course that's what we're going to do." A GSK spokesperson told Outsourcing-Pharma.com that at this point, the company cannot comment on who or where the potential beneficiaries of its outsourced work may be: "It will be decided on a case-by-case basis." What is known is that job cuts are planned. The majority of details have not been finalised regarding which sites would be axed, nor how many employees could be affected, although the company has said that troubled Cidra, Puerto Rico, plant would be the first to fall to its axe, with news on a number of UK plants fast on its heels.
Weekly / Daily Free Newsletter In-PharmaTechnologist.com Pharmaceutical Technology OutSourcing-Pharma.com Outsourcing Pharma LabTechnologist.com Laboratory Equipment
In terms of the effect this will have on the company's margin, Garnier told analysts that "clearly there will be significant improvement in terms of the cost saving program," although he warned that they may not materialise straight away.
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There are site closures and so some of the benefits of the cost saving programme will come toward the end of the [three year] cycle.
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Speaking on the company's ongoing plans to reduce infrastructure and improve efficiency, Garnier said that the firm now has a chance to expand these efforts a little bit beyond the classic areas of selling, general and administrative (SG&A) and manufacturing to also include research and development (R&D) and sales. In terms of R&D, the company has plans to increase the number of external collaborations it undertakes as well as embrace the budget option that is Asia. Only earlier this week, in fact, the company announced a multi-million dollar deal with Tolerx to develop and commercialise otelixizumab, a humanised anti-CD3 monoclonal antibody. Many other such preclinical collaborative deals are already in place with an array of specialist firms. Meanwhile, in July, GSK announced its intention to plant itself in China and establish a new R&D center to be based in Shanghai, which will eventually have full global responsibility to create medicines for neurodegenerative disorders, and also be well positioned to tap into the vast number of Chinese PhD graduates. The company is already quite active on the Indian pharma scene and now has its eye scanning for opportunities in other emerging Asian regions. "In terms of R&D, we have to talk first about where we are going to super invest," said Garnier. "We are building biologicals, first of all with some in-licensing but also with our own molecules…Of course we will also accelerate our establishment of R&D in China." Garnier pointed out that the company is looking at up to 25 new launches over the next three years, with products "that will come right on time…to replace what we are losing to the generics."
MORE NEWS ARTICLES ON THIS TOPIC GSK's UK plant to lose out to outsourcing China CRO attracts $30m US investment Nycomed takes bulk of API production offshore Pharma should keep outsourcing in mind GSK reviews Montrose API plant GSK buys Reliant for cardiovascular drugs Kemwell forges consumer health partnership with GSK GSK cut down by Avandia scare GSK axe begins to fall Copyright - Unless otherwise stated all contents of this web site are © 2000/2009 - Decision News Media SAS - All Rights Reserved - For permission to reproduce any contents of this web site, please email our Syndication department: Administration & Finance - Full details for the use of materials on this site can be found in the Terms & Conditions
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Appendix H: GSK Public Relation Tactic 2
GlaxoSmithKline: CR Report 2004 - Preferential pricing
http://www.gsk.com/responsibility/cr_report_2004/am_dc_preferential_p...
Search GSK.com
CR Report 2004 CEO/Chairman statement Employment practices Human rights Access to medicines Developing world Research & development Preferential pricing Eligibility for not-for-profit prices Voluntary licensing and partnerships
Developed world Leadership and advocacy Community investment Engagement with stakeholders Standards of ethical conduct Research and innovation Products and customers Caring for the environment Managing CR Summary of indicators About this report GRI index Case studies Downloads Feedback
Home Responsibility CR Report 2004 Access to medicines Preferential pricing
Preferential pricing
Preferential pricing There are many barriers to healthcare in developing countries. Most significantly, poverty, and a lack of political will, have led to a lack of medical infrastructure hospitals, clinics and medical professionals - that prevents poor people accessing the healthcare they need. The affordability of medicines is also important and there are two elements to this. First is the ability of governments or patients to pay for medicines. Solving this problem will require developed country governments and inter-governmental agencies to make significant additional financial resources available to developing countries. The second element is the price at which medicines are sold, an area GSK can help to address. We are making key medicines available to developing countries at more affordable prices and in sufficient quantities for as long as they are required. This is a major commitment that we call ‘preferential pricing’. All our AIDS and malaria treatments are available at not-for-profit prices to public sector customers and not-for-profit organisations in over 100 developing countries, including all the countries covered by the US President’s emergency plan for AIDS Relief (PEPFAR). Our prices are sustainable - we do not make a profit on them, but we do cover our manufacturing and distribution costs. Therefore we can sustain supply of these products for as long as they are needed. We aim to reduce not-for-profit prices for our ARVs and anti-malarial medicines whenever improvements in manufacturing, or economies of scale, allow. For example, Combivir, one of our key ARVs, is now available at $0.65 a day, compared with $1.70 in April 2003. This equates to around $237 per patient per year and includes delivery costs, which compares favourably with generic tablets. The February 2005 pricing report by Medecins Sans Frontieres shows that the average cost of generic equivalents is $0.75 a day and the lowest priced generic equivalent costs $0.55 a day. In addition, we negotiate public sector prices with middle-income developing countries on a case-by-case basis. These combine a viable and sustainable commercial return for GSK with increased affordability for the healthcare systems concerned. GSK vaccines are also available at preferential prices. Here we work with multinational organisations such as UNICEF, the World Health Organisation and the Pan American Health Organisation, governments and non-governmental organisations, to provide appropriate and affordable vaccines for the developing world.
Quick links Shipments of preferentially priced Combivir excluding diverted stock Supply arrangements by type of customer
Learn more about Preferential pricing US President’s emergency plan for AIDS relief (PEPFAR)
Background information View further information about how we calculate our injury and illness rates
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Progress in 2004 In 2004 we shipped 32.7 million preferentially-priced Combivir tablets to the developing world, with over 80% of these going to Africa. This is nearly three times the 11 million tablets shipped in 2003. We do not routinely collect data for our other preferentially-priced medicines but a similar increase has been experienced for Epivir, another of our ARVs. Overall shipments are still low given the scale of the AIDS epidemic in Africa but the growth is encouraging. More doctors, hospitals and clinics are needed to treat more patients and ensure better take up of preferentially priced medicines. Shipments of preferentially priced Combivir excluding diverted stock
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GlaxoSmithKline: CR Report 2004 - Preferential pricing
http://www.gsk.com/responsibility/cr_report_2004/am_dc_preferential_p...
2001
2002
2003
2004
(millions of tablets) 3.5
6
11
32
It is difficult to estimate the number of patients treated as a result of our preferential pricing agreements, since GSK does not control healthcare provision. A report from the UN-led Accelerating access initiative (AAI), suggests that by September 2004 more than 333,000 patients in developing countries were receiving ARV treatments supplied by the seven pharmaceutical companies in the AAI. This includes 157,500 patients in Africa, a 50% increase since September 2003. For more on GSK’s work with the AAI see Accelerating Access Initiative. At the end of 2004 we had 208 arrangements to supply preferentially-priced ARVs in 57 countries. This includes 30 agreements with private employers. We added new supply agreements with a number of middle-income countries during 2004. These include an agreement with the Chinese Ministry of Health for preferentially priced Epivir tablets to support China’s national HIV treatment programme, and a number of arrangements in Central and Eastern Europe. We are also introducing discount cards for senior citizens in several middleincome countries, see Developed world.
Supply arrangements by type of customer
Supply arrangements by type of customer 2000 AAI
2001
q4
q1
q2
q3
q4
2
4
10
13
17
Govt non
4
AAI
12
q1
2002
q2
q3
q4
q1
q2
q3
NGOs Public
5
hospitals
8
13
Employers
19
31
2
13
2003 AAI Govt non
2004
q4
q1
q2
q3
q4
2
4
10
13
17
q1
q2
q3
4
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Appendix H: GSK Public Relation Tactic 2 (cont.)
GlaxoSmithKline: CR Report 2004 - Preferential pricing
AAI
http://www.gsk.com/responsibility/cr_report_2004/am_dc_preferential_p...
12
NGOs Public hospitals
5 8
13
19
31
GSK in focus | Your health | Reports and publications | GSK worldwide | Contact us | Site map Terms and conditions | Accessibility | Your privacy | Procurement | Flu Information Source for GSK employees
Updated 30 January 2006 © 2001 - 2009 GlaxoSmithKline plc. All rights reserved. Registered in England and Wales No. 3888792. Product diversion, where not-for-profit medicines are illegally shipped back for Registered office: 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Employers
2
13
sale in wealthier countries, undermines our ability to provide not-for-profit prices and denies treatment to the intended patients in poorer countries. We can only afford to supply products at low prices in the world’s poorest countries if we can still make an adequate return on them in wealthier markets. We have introduced different packaging and tablet colours for many of our not-for-profit medicines to help prevent product diversion. Special tri-lingual ‘access packs’ are now approved for Combivir, Epivir and Trizivir in over 50 countries, and we are now receiving regulatory approvals for the red Epivir and Combivir tablets. GSK has nine ARVs registered under the EU’s Anti-Diversion Regulation. We are the only company to have registered products under this Regulation. We have set up five pilot projects in collaboration with NGOs in Tanzania, Uganda, Nigeria, Zambia and Malawi to assess the impact of extending preferential pricing to a wider range of products. Initial results show that lack of healthcare capacity and infrastructure are major barriers. When capacity (for example the number of healthcare professionals) or funding is improved there is an increase in take up of preferentially-priced medicines. For example two of the pilot sites have received funding from the US President’s Emergency Plan for AIDS Relief for the treatment of opportunistic infections. This has led to an increase in orders for antibiotics. A report on the findings from the pilots will be prepared at the end of 2005. Back to top
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Appendix I: GSK Public Relation Tactic 3
Developed world - CR Report 2005 - GlaxoSmithKline
CR Report 2005
http://www.gsk.com/responsibility/cr_report_2005/access-to-medicines/...
Home Responsibility CR Report 2005 Access to medicines
Developed world
Summary and highlights CEO/Chairman statement About this report Managing CR Access to medicines Developing world Developed world Research Ethical conduct Employees Human rights Environment Community investment Data summary Case studies PDF downloads Report index Feedback
Developed world Access to medicines is not just an issue for the developing world. Even in developed countries some patients cannot afford the medicines they need. This is a particular problem in the US where many people do not have health insurance. GSK has developed Patient Assistance Programs and discount cards in the US to help patients without insurance. We are also introducing discount cards in several middle-income countries to enable qualifying patients to obtain prescription medicines at a discount price. Programmes in the US Patient Assistance Programs provide prescription medicines to low-income, uninsured patients free or at minimal cost. GSK operates several programmes, including Commitment to Access which covers cancer treatments and Bridges to Access which covers other medicines for outpatients. Patients are registered through one phone call from a patient advocate and receive medicine at their local pharmacy or by mail order. In 2005, 565,000 patients received GSK medicines worth $463.8 million through these programmes, compared with $372.5 million in 2004. The value of the medicines is calculated using the wholesale acquisition cost (WAC).
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GSK was the first pharmaceutical company in the US to offer a card providing savings on medicines to low-income senior citizens and disabled people. Known as the Orange Card this enabled these people to buy GSK outpatient prescription medicines at a discount of up to 40%. In 2005, 205,672 Orange Card holders received 49,084 prescriptions, saving $5 million (based on WAC). In 2002, GSK and six other pharmaceutical companies established the Together Rx card which provided discounts on over 155 prescription medicines for low-income senior citizens who are eligible for Medicare. In 2005, 347,835 people received 463,901 GSK prescriptions through this programme, saving $7.5 million (based on WAC). Our access programmes in the US will change significantly in 2006 with the launch of a new Medicare prescription drug coverage programme. The Orange Card and Together Rx programmes finished on 31 December 2005 as those patients are now eligible for the new Medicare programme. We will report on the roll-out of these changes next year. In January 2005, GSK and nine other pharmaceutical companies created a new card to improve access to medicines for other uninsured Americans, not just seniors. The Together Rx Access card provides savings of 25-40% on more than 275 medicines. Approximately 36 million people, around 80% of uninsured people in the US, are eligible to enrol. The participating companies enrolled 353,113 people in 2005, who received 647,227 prescriptions worth $10.1 million (based on WAC). GSK assisted 10,947 of these patients, with 31,617 prescriptions, worth $2.9 million. Orange Cards in middle income countries In 2004 GSK introduced Orange Cards providing discounts on certain GSK prescription medicines for eligible patients in Bulgaria, Lithuania and Ukraine. The nature of the discounts varies between countries, depending on the needs of the patient and the way in which the healthcare system operates. Our Orange Card in the Ukraine gives all asthma and chronic obstructive pulmonary disease patients who are under 25 or over 50, an average discount of 19% on GSK’s Seretide asthma medicine. Asthma patients of any age who suffer disabilities or who are affected by the Chernobyl nuclear disaster are also eligible.
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Appendix I: GSK Public Relation Tactic 3
Developed world - CR Report 2005 - GlaxoSmithKline
http://www.gsk.com/responsibility/cr_report_2005/access-to-medicines/...
Eligibility is assessed by the patient’s doctor and patients can receive the medicine at participating pharmacies. A hotline number has been set up to help patients find their nearest pharmacy. In 2005, 3,500 patients enrolled and received discounts worth $176,000. In Lithuania, our Orange Card gives senior citizens an average discount of 40% on the patient co-payment on all GSK prescription medicines. So far more than 12,000 patients have applied for an Orange Card and 155 pharmacies are registered to participate. In 2005, 3,000 patients received discounts worth £20,000 ($36,400). In December we widened the group who are eligible for the Orange Card to include disabled people. A GSK Orange Card was also introduced in Bulgaria in May 2004 for low-income patients with chronic diseases such as asthma, chronic obstructive pulmonary disease and diabetes. Card holders receive an average 35% discount on four GSK prescription medicines. In 2005, 36,000 patients received discounts worth over Euro 1.4 million ($1.75 million)
Summary of GSK discount programmes Value of Benefit to Patients
Country
GSK Programme
Number of Patients
US
Patient Assistance Programs Free or minimal cost medicines for low-income, uninsured patients.
565,000 received prescriptions
$464 million
US
Orange Card - Discounts for low-income senior citizens and disabled people.
205,672 received prescriptions
$4.992 million
US
Together Rx - Discounts for low-income senior citizens. Joint industry programme.
347,835 received prescriptions
$7.561 million
US
Together Rx Access - Discounts for all low-income uninsured patients. Joint industry programme.
10,947 received prescriptions
$2.912million
Bulgaria
Orange Card - Discounts for low-income patients with chronic diseases.
36,000 patients received prescriptions
$1.75 million
Lithuania
Orange Card - Discounts for senior citizens and disabled people
12,000 enrolled
$36,400
Ukraine
Orange Card - Discounts on asthma medicine for patients under 25 or over 50.
3,500 enrolled
$176,000
Back to top
GSK in focus | Your health | Reports and publications | GSK worldwide | Contact us | Site map Terms and conditions | Accessibility | Your privacy | Procurement | Flu Information Source for GSK employees
Updated 30 January 2006 © 2001 - 2009 GlaxoSmithKline plc. All rights reserved. Registered in England and Wales No. 3888792. Registered office: 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
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Appendix J: GSK Public Relation Tactic 4
Advocacy on pricing and competitiveness - Public policy activity in 2008 ...
http://www.gsk.com/responsibility/advocacy-on-pricing-and-competitive...
Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on pricing and competitiveness
European activity Guiding principles for relative effectiveness assessments and pricing Organisations engaged: EU member states, the European Commission, stakeholder representatives participating in the EU’s High Level Pharmaceutical Forum Industry associations involved: EFPIA, EuropaBio GSK position: Government funding decisions are often based on an assessment of a medicine’s clinical or cost effectiveness. We believe that these value assessments should be conducted transparently and in a timely manner and all key stakeholders should be able to submit evidence for the assessments. Governments should allow greater pricing flexibility when the long-term value of a medicine is not certain at launch. GSK, representing EFPIA, strongly supported the Good practice principles for relative effectiveness assessments which were developed within the framework of the EU’s High Level Pharmaceutical Forum (HLPF). These were adopted in 2008 along with the Guiding principles for good practices implementing a pricing and reimbursement policy. EFPIA’s Health Technology Assessments principles, which the industry has previous adopted and that GSK helped to develop, are aligned with the principles adopted by the HLPF. Improving regulations that impact on the pharmaceutical industry’s competitiveness in the UK Organisations engaged: UK government and the European Commission Industry associations involved: ABPI, CBI, Institute of Directors GSK position: The pharmaceutical industry is one of the most highly regulated industries in Europe. GSK supports strong regulation but has been working with the UK government and the European Commission to propose ways to simplify regulations while achieving the same policy goal. This aligns with the aims of the UK government and European Commission to reduce the regulatory burden placed on industry. GSK submitted a series of 50 proposals to the UK government for simplification 1 of 2
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Appendix J: GSK Public Relation Tactic 4, (cont.)
Advocacy on pricing and competitiveness - Public policy activity in 2008 ...
http://www.gsk.com/responsibility/advocacy-on-pricing-and-competitive...
of existing regulations. We also made a similar submission to the Commission, focusing on regulations that originate at a European level. Back to top
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Legislative Education Campaign National Treatment Education Training Human Immunodeficiency Virus and Methicillin Resistant Staphylococcus Aureus: A Live National Satellite Videoconference and Webcast Series 2009 Annual Meeting Fellows-in-Training Program 2009 Annual Meeting Fellows-in-Training Travel Scholarships 2009 Fellows Career Development Awards 2009 Virtual Annual Meeting Controversial Topics in the Management of Rhinitis Pulmonary / Critical Care and Allergy / Immunology Fellows Career Development Awards Program Wisconsin Allergy Society 2008 Annual Meeting 60th Annual Scientific Assembly & Exhibition Asthma Control: Making the Best Decision Managing the Patient with Hypertriglyceridemia: A Practical Approach for Nurse Practitioners Patient Counseling Manual on the Topic of Hypertriglyceridemia Diagnosis and Management of Rhinitis: A Continuing Medical Education Curriculum 2008 Chemistry in Cancer Research Award Support District IV 2009 Meeting Providing Education and Training for Veterinarians, Managers, Supervisors and Technicians Support the Development of Public Outreach Projects about Laboratory Animal Research and Medical Research American Association of Clinical Endocrinologists: Diabetes Day for Primary Care Georgia Chapter of the American Association of Clinical Endocrinologists Annual Meeting and Symposium Support Second Annual Frontiers in Medicinal Chemistry Conference Donation for the H. C. Brown Award Symposium Continuing Medical Education Review Articles in the Annals of Allergy, Asthma & Immunology 41st Annual New York Cardiovascular Symposium
Acquired Immune Deficiency Syndrome Project - Alabama
Acquired Immune Deficiency Syndrome Project - Los Angeles
Albany Medical College
American Academy of Allergy
American Academy of Allergy
American Academy of Allergy
American Academy of Allergy
American Academy of Allergy
American Academy of Allergy
American Academy of Allergy
American Academy of Family Physicians Georgia Chapter
American Academy of Family Physicians Texas Chapter
American Academy of Nurse Practitioners
American Academy of Nurse Practitioners
American Academy of Physician Assistants
American Association for Cancer Research
American Association for Laboratory Animal Science - RTB
American Association for Laboratory Animal Science Foundation
American Association of Clinical Endocrinologists
American Association of Clinical Endocrinologists
American Chemical Society
American Chemical Society Division of Organic Chemistry
American College of Allergy & Immunology
American College of Cardiology Foundation
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Corporate Sponsorship Program for 2008-2009
Project Description
4th Quarter 2008
Academy of Surgical Research
Organization Name
Appendix K: GSK Public Relation Tactics 5 & 6
Grants & Charitable Contributions to US Based Healthcare Organizations
GlaxoSmithKline Public Relations Plan & Case Study
1
$5,000
$29,696
$1,000
$1,000
$5,000
$31,725
$7,600
$1,900
$15,000
$67,310
$32,804
$52,186
$5,000
$5,000
$3,200
$450,000
$47,500
$45,000
$400,000
$27,500
$25,000
$2,500
$25,000
$10,000
$3,800
Amount
Page 445
10th National Conference on Anticoagulant Therapy Managing Human Papillomavirus: A New Era in Patient Care
Anticoagulation Forum, Inc.
Association of Reproductive Health Professionals
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Annenberg Center at Eisenhower
Angiogenesis Foundation, Inc.
Annenberg Center at Eisenhower
Outreach Initiative: Veterinarians Speaking for Research
Americans For Medical Progress
"The Best of Antiangiogenesis": Webcast with highlights from The Judah Folkman 6th International Conference Antiangiogenesis: New Frontiers in Therapeutic Development Evolving Treatment Strategies for Chronic Immune Thrombocytopenic Purpura in the Veterans Health Administration System Evolving Treatment Strategies for Chronic Immune Thrombocytopenic Purpura in the Veterans Health Administration System
Support 2009 Educational Initiatives
2
American Social Health Association
American Veterinary Medical Association
Cervical Cancer Prevention Education Project
American Physiological Society
Webinars: 1. Prostate Cancer Prevention and 2. Understanding Risk
Support Endowment Fund for Annual Scholander Award for 2009
American Pharmacists Association
American Urological Association Education and Research
Joint Forces Pharmacy Seminar 2008, Clinical and Pharmacology Updates, Information Systems and Medication Management
American Liver Foundation
2009 American Thoracic Society Travel Scholarship Program
Think B: Hepatitis B Information You Need to Know
American Heart Association
American Thoracic Society, Inc.
The Acute Coronary Syndrome Continuum: Current and Emerging Management Strategies
American Health Resources, Inc.
Support Summer Internship in Laboratory Animal Medicine for Veterinary Students
PharmEd: Human Immunodeficiency Virus Drug Therapy Update for the Pharmacist
American Diabetes Association
American Society of Laboratory Animal Practitioners
American Diabetes Association 68th Scientific Sessions: Scientific Highlights
American College of Laboratory Animal Medicine
American Society of Hypertension
Support the American College of Laboratory Animal Medicine Forum Innovation in Laboratory Animal Management & Medicine
Advances in the Management of Postoperative Ileus: Reducing the Clinical and Economic Burden
Education Symposia Programs at the 2008 Annual Meeting.
American College of Gastroenterology
Symposia and Enduring Material Beta Blockers and Hypertension in 2008: Differentiating Mechanisms and Addressing the Evidence
$11,400
Similarities and Differences in Asthma and Chronic Obstructive Pulmonary Disease
American College of Chest Physicians
American Society of Health System Pharmacists
$35,000
Chronic Obstructive Pulmonary Disease: 2009
American College of Chest Physicians
$110,000
$10,000
$42,951
$121,697
$25,000
$85,500
$19,000
$17,130
$25,000
$7,600
$22,617
$231,150
$45,000
$1,000
$4,500
$50,000
$50,753
$4,400
$26,000
$21,018
$42,036
$172,633
Chronic Obstructive Pulmonary Disease Patient Management: A Comprehensive Approach
American College of Chest Physicians
$112,104
Amount
American College of Chest Physicians
Project Description
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CHEST 2008 Educational Symposium Prophylaxis of Venous Thromboembolism in the Medical Patient: The Good, the Bad, and the Ugly
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
30th Anniversary Celebration (Breast Cancer) Can't Catch Your Breath? Come Get Tested Asthma Grand Rounds at Partners Asthma Center Partners Asthma Center's Quarterly Patient Newsletter: Breath of Fresh Air Immunization Advocacy and Education 15th Annual Clinical Management of Heart Disease: Cardiology Update 2008 Lymphatic Filariasis Elimination Activities Improving Healthcare Quality in Chronic Care 2008 Breakthrough Ball Sponsor
Boys & Girls Clubs of Greater Washington
Breast Cancer Network of Strength
Breathe New Hampshire
Brigham & Women's Hospital, Inc.
Brigham & Women's Hospital, Inc.
California Coalition for Childhood Immunization
Cardiovascular Institute of Philadelphia
Carter Center
Center for Health Care Strategies
Children's Cancer And Blood Foundation
3
FitU and FitFamily Program
Board of Trustees of the University of Illinois
Annual Physician and Surgeon Convention of PR College Contribution for 14th Annual Meeting Nov 13-15, 2008 A Chocolate Affair for Cancer Support Programs Chronic Obstructive Pulmonary Disease Management: State of the Art Support the Funding for the Annual Laboratory Animal Science and Technology Seminar Chronic Obstructive Pulmonary Disease: Improving Treatment, Maximizing Benefit Diagnosing and Treating Co Morbidities in Patients with Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome Discovery Health Channel Multiplatform--Migraine: Relieving the Burden
Colegio de Medicos Cirujanos de Puerto Rico, Inc.
Connective Tissue Oncology Society
Cornucopia House
Danbury Hospital
Delaware Valley Branch - American Association for Laboratory Animal Science
Discovery Communications, LLC
Discovery Communications, LLC
Discovery Communications, LLC
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Membership Renewal - Corporate Benefactor
Cold Spring Harbor Laboratory
Clinical Care Options
Clinical Care Options
$2,500
Committed to Caring II: African American and Latino Clinicians Responding to Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome.
Clinical Care Options Official Conference Coverage of the Forty-Eighth Annual Interscience Conference on Antimicrobial Agents and Chemotherapy/Infectious Diseases Society of America Annual Meeting Clinical Care Options Official Conference Coverage of the Twenty-Seventh International Acquired Immune Deficiency Syndrome Conference
$2,500
2009 Cardiovascular Conference: Advances in Cardiovascular Therapy
Baylor University Medical Center
$146,667
$223,050
$98,825
$1,900
$4,000
$10,000
$20,000
$5,000
$50,000
$73,064
$96,587
$15,000
$1,000
$250,000
$3,000
$20,000
$10,000
$4,000
$3,500
$1,000
$400,000
$1,500
The 3rd Annual Cardiovascular Nursing Symposium
Atlanticare Regional Medical Center
$95,000
Amount
Understanding and Treating Menstrual Migraine
Project Description
Page 447
Association of Reproductive Health Professionals
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Understanding Rotavirus Vaccination
Discovery Communications, LLC
Hepatology Fellowship for 7/1/08-12/31/08 Movement Disorders Program Newsletter Early Detection of Breast Cancer in Young, Low-Income African American Women Healthy Lifestyles (Obesity) Program Expansion Donation to the 47th Annual Meeting 4th Annual Georgetown Breast Cancer Update: Emerging Trends in the Management of Breast Cancer Advancing Treatment Paradigms in Hematologic Malignancies: Highlights from the 50th American Society of Hematology Annual Meeting OncoBeat American Society of Hematology: Reporting the News…Beating Cancer, St. Vincent's 6th Annual Indy Hematology Review Mujer Sana - Latina Cervical and Breast Cancer Early Detection Program General Support for the Organization's Mission Support new programs in 2009 - Educating the Public about the Essential Role of Laboratory Animals to Advance Human Health Update in the Management of Asthma Support Symposium - Cancer, Prevention and Detection Research Breast Health Outreach and Counseling Program GSK Research & Education Foundation for Cardiovascular Disease Award Program for Young Investigators Award Winner 2009 Update in Oncology 2009 Annual Winter Continuing Medical Education Conference Support 2009 Cell Biology of Megakaryocytic and Platelets
Duke University
Duke University
Duke University Medical Center
Duke University Medical Center
Eastern Pharmaceutical Technology
Educational Concepts Group LLC
Educational Concepts Group LLC
Educational Concepts Group LLC
Educational Concepts Group LLC
El Pueblo
Epilepsy Foundation of America
Foundation for Biomedical Research
Franklin Square Hospital, Inc.
Friends of Cancer Research
Fund for Philadelphia
General Hospital Corporation
Genesys Regional Medical Center
Georgia Association of Physician Assistants, Inc.
Gordon Research Conferences
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Antithrombotics in Acute Coronary Syndrome
Duke University
Discovery Institute of Medical Education (DIME)
Discovery Institute of Medical Education (DIME)
Understanding Rotavirus Vaccination
Discovery Communications, LLC
American Society of Health-System Pharmacists Symposia: Integrating Treatment Guidelines for Acute Coronary Syndrome into Clinical Practice: Antiplatelet and Anticoagulant Therapies The New Anticoagulant Array for the Acute Coronary Syndromes: Differentiating Agents in the Latest Guidelines to Simplify Selection
Discovery Health Channel Multiplatform--Migraine: Relieving the Burden
Project Description
Discovery Communications, LLC
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
4
$10,000
$20,000
$3,000
$55,000
$100,000
$75,000
$2,100
$55,500
$275,000
$75,000
$10,000
$15,000
$5,000
$10,000
$500
$25,000
$25,000
$3,000
$28,448
$17,500
$33,185
$186,180
$44,825
$50,000
$146,666
Amount
Page 448
5
Cervical Cancer Patient Education Web Site Initiative
Gynecologic Cancer Foundation
$6,600
$3,000 $3,800
Best of the Day from the 2008 San Antonio Breast Cancer Symposium Lymphoma & Myeloma 2008 Overcoming Rituximab Resistance: Satellite Symposium at Lymphoma & Myeloma 2008 Annual Interscience Conference on Antimicrobial Agents and Chemotherapy/Infectious Diseases Society of America forty-sixth Annual Meeting Human Immunodeficiency Virus Business Reception Understanding Immune Thrombocytopenic Purpura Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome Advanced Clinical Update: 2008 Medical/Surgical Treatment of Deep Vein Thrombosis / Pulmonary Embolism Support 2009 programs Understanding What Is New About Hepatitis One Year Subscription - This is the First of a Three Year Sponsorship Clinical Dilemmas in the Treatment of Venous Thromboembolism Improving the Management of Human Immunodeficiency Virus Disease: An Advanced Course in Human Immunodeficiency Virus Pathogenesis, Antiretrovirals, and Other Selected Issues Bronze Sponsorship International Humanitarian Relief Recent Advances in Pulmonary and Critical Care Medicine Support Lectures on Key Topics in the Field of Humane Science and Methods in Research Spearheading the Development of Alternatives
Imedex
Imedex
Imedex
Infectious Diseases Society of America Research and Education Foundation
Information Television Network
Inova Health System Foundation
Inova Health System Foundation
Institute for Laboratory Animal Research
Institute for Professional Development in the Addictions
Institute of Medicine of the National Academies
Integris Baptist Medical Center
International Acquired Immune Deficiency Syndrome Society - USA
International Gynecologic Cancer Society
Intervol
John Butler Lung Foundation
John Hopkins University - Center for Alternative to Animal Testing
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
$1,800
A Roundtable Exploration of Best Practices & Updates in Immunization
Illinois Pharmacists Association
$1,000
$15,000
$85,000
$100,000
$85,500
$10,000
$1,500
$130,000
$7,500
$52,568
$30,000
$10,000
$5,000
$8,000
Seventh Annual Convention and Scientific Meeting
HIV Treaters Medical Association of Puerto Rico, Inc.
$2,000
26th Annual DHMC Cardiovascular Disease Update Symposium 2008
$15,440
$105,712
$50,000
Hitchcock Medical Center
Health Science Center
Haymarket Medical Education
African American Women Living Healthy
Gynecologic Cancer Foundation
Satellite Symposium and Enduring Material at American Academy of Physician Assistants (AAPA) Congress "Dyslipidemia: The Rest of the Story" 2008 Community Pharmacist Continuing Education Program: Achieving Glycemic Control in Type II Diabetes: Where Are We in 2008?
$3,500
Grand Rapids Area Medical Education Center
$40,000
$3,000
Grand Rapids Clinical Oncology Program’s 13th Annual Distinguished Lecture Series “Oncology Research Update 2008”
Amount
Asthma Crisis 2008: Ethnic Disparities, National Guidelines, and Community Based Strategies
Project Description
Page 449
Grand Rapids Area Medical Education Center
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Cardiovascular Topics at Johns Hopkins Support 2009 Meeting Season - Director's Fund 2008 Kidney Cancer Association Annual Meeting Melanoma Grand Rounds Charitable Donation Support Their Mission: Providing Patient Support and Advocacy for Patients Living with or at Risk of the Disease 2008 Forum for Discovery Life without Lupus Gala 2008 2008 North American Educational Forum on Lymphoma March of Dimes Great Chefs of the Triangle Sponsorship 13th Annual Massachusetts Immunization Action Partnership: Skills Building Conference Maternal and Child Health Programs Maternal and Child Health Programs Hematology/Oncology Department Briefings: Update in the Treatment of Immune Thrombocytopenic Purpura Managing Triglycerides: A Crucial Component of Cardiovascular Risk Reduction Key Concepts for Unlocking the Door to Detection and Management of Genital Herpes Updates in Hypertension Updates in Type 2 Diabetes Grand Rounds: Hormones and Headache 2008 San Antonio Breast Cancer Update Managing the Patient with Potential Genital Herpes and Human Immunodeficiency Virus Coinfection Not So Uncomplicated: Issues in the Treatment of Impetigo in the Age of Antibacterial Resistance Prostate Cancer Awareness in Primary Care: Dilemmas and Opportunities
Johns Hopkins University
Johns Hopkins University
Keystone Symposia
Kidney Cancer Foundation
Little Falls Hospital
Long Island Association for Acquired Immune Deficiency Syndrome Care
Lung Cancer Alliance
Lupus Research Institute Incorporated
Lupus Research Institute Incorporated
Lymphoma Research Foundation
March Of Dimes Birth Defects National Foundation
Massachusetts Chapter of The American Academy of Pediatrics
Maternity Care Coalition
Maternity Care Coalition
McMaster University Ontario
Med Institute
Med Institute, LLC
Med Institute, LLC
Med Institute, LLC
Medical College of Ohio at Toledo Foundation
Medical Society of Delaware
Medscape
Medscape
Medscape
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
A Comprehensive Review of the Recommendations for Vaccination in Infants, Children, Adolescents, and Adults
Johns Hopkins University
Project Description 10th Annual Human Immunodeficiency Virus Update for The Johns Hopkins Acquired Immune Deficiency Syndrome Service County Program Nurses and Case Managers
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
6
$22,875
$19,750
$18,000
$3,000
$2,500
$60,000
$60,000
$60,000
$72,805
$155,750
$1,000
$1,000
$3,500
$5,000
$10,000
$15,000
$25,000
$50,000
$5,000
$1,850
$82,500
$25,000
$5,000
$97,310
$2,850
Amount
Page 450
6th Annual World Congress on the Insulin Resistance Syndrome Colon and Rectal Surgery: PrIncorporatediples and Practice Course 2008 Fall 2008 Chronic Obstructive Pulmonary Disease Program Clinical Case Reviews in Migraine Management Diagnosis; Acute Management; Prevention; Comorbid Depression & Anxiety Innovative Cancer Therapy for Tomorrow: Chemotherapy Foundation Symposium XXVI New Drug Update Anticoagulation Update National Acquired Immune Deficiency Syndrome Treatment Advocacy Project Treatment Education Program Membership Dues for 2009 Chronic Obstructive Pulmonary Disease: Enhancing Recognition and Improving Outcomes Dinner Under the Desert Sky Update on the Drug Therapy Management of Allergic Rhinitis Renewal of Annual Membership 31st Annual Pulmonary and Allergy Update at Keystone Making the Right Diagnosis: The Need for Spirometry
Metabolic Endocrine Education Foundation
Minnesota Colon and Rectal Foundation
Minnesota Pharmacists Association
Montefiore Medical Center
Mount Sinai School of Medicine of New York University
Mountain Area Health Education Center, Inc.
Naples Community Hospital, Inc.
National Acquired Immune Deficiency Syndrome Treatment Advocacy Project
National Association for Biomedical Research
National Association for Continuing Education
National Association of Boards of Pharmacy
National Community Pharmacists Association
National Institute of Statistical Sciences
National Jewish Medical and Research Center
National Jewish Medical and Research Center
Heparin Induced Thrombocytopenia Grand Rounds Series Prostate Cancer: Keeping Abreast of the Current Concepts and Latest Advances" CME Grand Rounds Program Allergy Nurses Course New Orleans Acquired Immune Deficiency Syndrome Task Force Twenty-Fifth Anniversary Campaign Monthly Educational Symposia
Network for Continuing Medical Education
Network for Continuing Medical Education
New England Society of Allergy Nurses
New Orleans Acquired Immune Deficiency Syndrome Task Force
New York County Medical Society
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Donation in Memory of Carol R. Dewalt
National Multiple Sclerosis Society
National Lipid Association
National Lipid Association
Triglycerides in Cardiovascular Disease Risk Management
Medscape
National Lipid Association Satellite Symposium, Monograph and Web Activity "Dyslipidemia: Assessing Coronary Risk Factors in the Lipid Profile to Optimize Intervention" National Lipid Association Satellite Symposium, Monograph and Web Activity "Dyslipidemia: Assessing Coronary Risk Factors in the Lipid Profile to Optimize Intervention"
Triglycerides in Cardiovascular Disease Risk Management
Project Description
Medscape
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
7
$9,500
$35,000
$5,000
$23,574
$59,776
$100
$31,650
$94,958
$250,000
$25,000
$10,000
$77,508
$5,000
$100,000
$30,000
$120,000
$9,350
$1,650
$22,500
$20,000
$4,000
$5,500
$20,000
$77,000
$231,000
Amount
Page 451
Best Practices for the Management of Human Immunodeficiency Virus Associated Neurocognitive Disorders Patient Centered Approaches to the Management of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome: An Update on the Safety, Efficacy, and Dosing of Protease Inhibitors Annual Institutional Membership Dues North Carolina Chapter/American College of Physicians 2009 Scientific Session 2009 Annual Meeting Support Two Yearly Meetings in 2009 Graduate Traineeship 5/16/08-12/15/08 Installment Payment Graduate Traineeship 8/15/08-8/15/09 Installment Payment Graduate Traineeship 5/16/08-12/15/08 Installment Payment Graduate Traineeship 8/16/08-10/15/08 Installment Payment Graduate Traineeship 5/16/08-12/15/08 Installment Payment Graduate Traineeship 5/16/08-12/15/08 Installment Payment Graduate Traineeship 8/15/08-8/15/09 Installment Payment Support Logic and Cognitive Science Lecture and Undergraduate Internship
North American Center for Continuing Medical Education, LLC
North American Center for Continuing Medical Education, LLC
North Carolina Association for Biomedical Research
North Carolina Chapter, American College of Physicians
North Carolina Neurological Society
North Carolina Regional Chapter of the Society of Toxicology
North Carolina State University
North Carolina State University
North Carolina State University
North Carolina State University
North Carolina State University
North Carolina State University
North Carolina State University
North Carolina State University - College of Humanities & Social Sciences
8
$190,710
Changing Concepts in the Management of Human Immunodeficiency Virus Disease 2009
New York University
26th Annual Infectious Disease Seminar for the Practicing Physician 2008 GSK Chemistry Scholar Award Lynn Sage Breast Symposium Lynn Sage Symposium: Targeted Therapies: Manipulating the Biology of Breast Cancer The 45th Annual Year in Internal Medicine Conference
Northeastern Ohio Universities College of Medicine
Northwestern University
Northwestern University
Northwestern University
Northwestern University
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
2009 North Carolina Veterinary Conference Sponsorship - Support 14th Annual Conference
North Carolina Veterinary Conference
North Carolina State University Physical & Mathematical Sciences Foundation, Inc Graduate Program Support
$309,500
2008 Annual Conference
New York State Society of Physician Assistants Inc.
$5,000
$44,000
$41,250
$20,000
$3,000
$4,750
$103,950
$20,000
$3,660
$3,660
$3,660
$3,720
$3,615
$3,615
$7,230
$1,000
$5,000
$3,000
$57,000
$45,000
$5,000
$5,000
New York State Society of Physician Assistants 2008 Annual Continuing Medical Education Conference
New York State Society of Physician Assistants Inc
$2,000
Amount
Advances in Medical and Interventional Treatments for Chronic Obstructive Pulmonary Disease
Project Description
Page 452
New York Medical College
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Red Tie Night 2009 Educating Your Patient: Herpes Simplex Virus Testing, Counseling & Treatment Eliminating the Transmission of Hepatitis A and B through Vaccination: Women s Health Annual Visit 2008 Diabetes and Endocrine Update 2009 Critical Care Update Parkinson Action Network: 15th Annual Morris K. Udall Awards Dinner Parkinson s Unity Walk 2008 Membership Patient Advocate Foundation Co-Pay Relief Program Autoimmune Disease Silo Grand Rounds: Managing Difficult to Manage Asthma Support Educational Initiatives - Training, Education and Programs Support Educational Programs and Initiatives Pharmacy Based Immunization Delivery Joint National Committee 8 Impact: New Approaches to Cardiovascular Risk Reduction Donation in Memory of Margaret Himes Continuing Medical Education Paper Symposium on Secondary Immune Thrombocytopenic Purpura: Seminars in Hematology Immune Thrombocytopenic Purpura Online Monograph Series 7th Annual Future of Breast Cancer Congress Controversies in Breast Cancer, Adjuvant and Neoadjuvant Therapy Evolution in ErbB2 Targeted Therapeutics for Breast Cancer Integrated Curriculum in Chronic Lymphocytic Leukemia 2009 Oncology Best Practices Advances in Breast Cancer Oncology Dialogue on Evolving Standards of Care for Chronic Lymphocytic Leukemia: OncoLogue Online Breast Cancer Curriculum
Oklahoma Acquired Immune Deficiency Syndrome Care Fund
Omnia
Omnia
Park Nicollet Institute
Park Nicollet Institute
Parkinson's Action Network Foundation
Parkinson's Unity Walk, Inc.
Partnership for Quality Medical Donations
Patient Advocate Foundation, Inc.
Pennsylvania Hospital
Pennsylvania Society for Biomedical Research
Pennsylvania Veterinary Medical Association
Pharmacists Society of the State of New York
Philadelphia Health and Educational Corp,
Phoenixville Hospital Cancer Center
Physicians Academy for Clinical and Management Excellence
Physicians Academy for Clinical and Management Excellence
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
"Obesity: Fundamentals and Frontiers" Continuing Medical Education
Project Description
NYU Post-Graduate Medical School
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
9
$15,000
$25,000
$272,000
$300,000
$146,144
$96,250
$7,500
$122,250
$30,645
$100
$5,000
$5,000
$7,600
$57,000
$1,650
$200,000
$15,000
$5,000
$10,000
$1,500
$1,500
$102,000
$149,250
$5,000
$25,000
Amount
Page 453
2008 Fall Seminar: Management of the Allergic Asthma Patient Street Medicine Institute, Symposia and New Programs 2008 Cutting Edge of Sleep Conference: New Research; New Directions
Physicians Education Resource Group, LP
Piedmont Association of Physician Assistants
Pittsburgh Mercy Foundation
Postgraduate Institute for Medicine
10
Emerging Pathways with Therapeutic Potential in Cancer
Physicians Education Resource Group, LP
Fifty-Ninth Annual Meeting of the PR Urological Association Patient Education Program 6th Annual Contemporary Issues in Multidisciplinary Breast Cancer Management Update in Pulmonary & Critical Care Medicine Third Annual Advances in Sleep Medicine Improving Deep Vein Thrombosis Prevention and Detection in High Risk Specialties 2008 Breast Cancer Update: An Audio Review Journal for Medical Oncologists
ProCom
Puerto Rico Urological Association, Inc.
Pulmonary Hypertension Association, Inc.
Regents of the University of Michigan
Regents of the University of Michigan
Regents University of California Los Angeles
Research Institute for Texas Health Resources
Research to Practice
Respiratory Rally
Respiratory Health Association of Metropolitan Chicago
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Visiting Professors: Clinical Investigators Visit the Clinics of Practicing Oncologists
Research to Practice
Research to Practice
Research to Practice
Research to Practice
Continuing Medical Education Dinner Meetings in Type 2 Diabetes Mellitus
ProCom
Breast Cancer Update Journal Club: A Multidisciplinary Review of New Data Presented at the 2008 San Antonio Breast Cancer Symposium and in Other Recent Peer Reviewed Publications Cancer Conference Update: An Audio/Podcast Review of Key Presentations and Posters from the 2008 American Society of Hematology Annual Meeting Hematologic Oncology Update 2009 Edition: An Audio Review Journal for Medical Oncologists and Hematologists
$15,000
American Diabetes Association Navigating the Storm: Debating Effective Treatment Plans with Oral Agents for Diabetes
$5,000
$62,837
$75,000
$12,500
$25,000
$43,899
$34,104
$5,000
$3,000
$3,000
$15,000
$10,000
$192,724
$64,419
2008 Pri-Med Meeting: Benefit to Risk Ratios for Treatments of Type 2 Diabetes
$123,816
$40,000
$15,000
$350,000
$2,000
$125,000
ProCom
Postgraduate Institute for Medicine
Postgraduate Institute for Medicine
$20,000
Conversations with the Experts: A Discussion on New Data and Highlights from the 2008 American Society of Hematology Meeting
Clinical Care Options Independent Conference Coverage of the 2008 Annual Meeting of the American Society of Hematology Treatment of Thrombocytopenia in Patients With Chronic Hepatitis C: Potential Impact on Treatment Candidacy and Outcomes
$53,282
Receptor Based Therapeutics: An Interactive Expose
Physicians Education Resource Group LP
$27,050
Progress in Antiangiogenic Therapies for Kidney Cancer
Physicians Education Resource Group LP
$15,381
Amount
Online Hematologic Malignancies Core Curriculum
Project Description
Page 454
Physicians Education Resource Group LP
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
35th Annual Meeting for the Society for Pediatric Dermatology 2009 Society of Toxicology Affiliates Dues Diamond Sponsorship Corporate Sponsorship Program for 2008-2009 Breath of Life Ball Acute Coronary Syndrome Support 2009 programs including SUBR Excellence in Biomedical Research Award Cardiology Millennium Conference LF Support Centre at Noguchi Mectizan Donation Program Acute Coronary Syndrome Neurology Update I: Headache 8th Annual Multidisciplinary Genitourinary Oncology Course
Society for Pediatric Dermatology
Society of Toxicology
Society of Toxicology
Society of Toxicology Mid-Atlantic Chapter
Southern California Chapter
St Joseph's Hospital and Medical Center
States United for Biomedical Research
SwedishAmerican Hospital
Task Force For Child Survival And Development
Task Force For Child Survival And Development
Temple University
The American Academy of Neurology
The Cleveland Clinic Educational Foundation
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
21st Annual Pre American Academy of Dermatology Meeting of the Society for Pediatric Dermatology
SciMed
SciMed
SciMed
SciMed
Society for Pediatric Dermatology
Sponsor Scientists Center for Animal Welfare Meetings and Sessions for 2009
Scientists Center for Animal Welfare
SPED Convention and Post Graduate Diabetes Course
Optimizing Care Delivery to Patients with Primary or Secondary Immune Thrombocytopenic Purpura
Scienta
Sociedad Puertoriqueña de Endocrinologia y Diabetologia, Inc.
Optimal Management of Asthma: Using the Right Tools
Scienta
SciMed
Key Concepts for Unlocking the Door to Detection and Management of Genital Herpes
Scienta
A Contemporary Issue in Clinical Medicine: Reducing Risk of Coronary Heart Disease in Patients with Hypertriglyceridemia Associated Mixed Dyslipidemia A Contemporary Issue in Clinical Medicine: Reducing Risk of Coronary Heart Disease in Patients with Hypertriglyceridemia Associated Mixed Dyslipidemia Fish Derived Omega 3 Fatty Acids: The Role of Eicosapentaenoic (EPA) and Docosahexaenoic (DHA) in Human Health Maintaining Cardiovascular Health in Patients with Mixed Dyslipidemia: Optimizing the Management of Hypertriglyceridemia and Non HDL Cholesterol Reducing Cardiovascular Risk in Patients with Mixed Dyslipidemias: Effective Management of Triglycerides and Non High Density Lipoprotein Cholesterol
Nevada Immunization Coalitions Immunization Advocacy Nevada Vaccines For Children Only Transition
Project Description
Saint Mary's Foundation
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
11
$2,500
$10,000
$2,500
$272,884
$76,000
$3,000
$4,750
$3,150
$3,000
$1,000
$12,000
$2,500
$5,000
$2,500
$5,000
$51,972
$133,606
$35,755
$33,067
$196,248
$10,000
$46,647
$231,626
$14,754
$10,000
Amount
Page 455
$349,851 $116,675
Achieving Effective Breast Cancer Management: Individual Patient Profiles and Targeted Treatment Strategies Expert Insight on the Future of Targeted Breast Cancer Therapy Heparin Induced Thrombocytopenia 2008 Clinical Curriculum Initiative Immune Thrombocytopenic Purpura 2008 Clinical Curriculum Initiative Implementing a Multimodal Management Strategy for Postoperative Ileus: Clinical Assessment, Monitoring, and Treatment Support for the Nursing Community Phase I of the 2009 Venous Thrombosis Embolism Curriculum: Inter Disciplinary Hospital Grand Rounds Pri Med Updates: Revisiting the Role of Beta Blockers in the Management of Hypertension A Closer Look at Complicated Cases The Breast Cancer Clinical Companion: A Summation of Clinical Evidence from 2007 Highlights of American Society of Hematology 2008 Highlights of American Society of Hematology 2008 2008 Columbus Diabetes University Dermatology Grand Rounds Neurology Grand Rounds: Outpatient Management of Headache Patients at Risk for Venous Thromboembolism: Exploring Options for Safe and Effective Prophylaxis Satellite Symposium Held in Conjunction with Annual Scientific Meeting Meeting the Joint Commission on the Accreditation of Healthcare Organizations Anticoagulation Patient Safety Goals: Case Studies and Local Experience Have Your Voice Heard by Officials and Providers Sponsor the UCLA/TORI Oncology Network Research Conference Substance Abuse Treatment and Prevention Research Programs The Evolution of Personalized Medicine in Breast Cancer Diagnosis and Treatment Diagnosis, Prevention and Treatment of Migraine and Bipolar Disorder
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society
The Medical Center, Inc.
The Pennsylvania State University
The Pennsylvania State University
The Physicians Academy for Clinical and Management Excellence
The University of Arizona Foundation
The University of Connecticut School of Pharmacy
Together Incorporated
Translational Oncology Research International
Treatment Research Institute
Trinitas Hospital
Trustees of Columbia University in the City of New York
12
$19,769
2008 Heparin Induced Thrombocytopenia Continuing Education Initiative / American Association of Critical Care Nurses Symposium
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
$35,000
Tenth Antiepileptic Drug Trials
The Epilepsy Study Consortium, Inc.
$46,190
$3,000
$1,000
$10,000
$5,000
$3,000
$19,952
$382,455
$3,550
$5,000
$5,000
$5,000
$5,000
$5,000
$31,753
$152,230
$197,308
$5,000
$5,000
$10,000
Cleveland Clinic Epilepsy Symposia 2009
The Cleveland Clinic Educational Foundation
$5,000
Amount
American Society of Hematology Review
Project Description
Page 456
The Cleveland Clinic Educational Foundation
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Coverage of Immune Thrombocytopenic Purpura at the American Society of Hematology: 50th Annual Meeting Neurology Symposium: Essentials for Your Practice Neurology Update 2008 2008 GSK Chemistry Scholar Award
Trustees of the University of Pennsylvania
University Hospital
University of Arkansas for Medical Sciences
University of California Berkeley
Reclaiming Control: Life After Breast Cancer 12th Annual Cincinnati Comprehensive Breast Cancer Conference Clinical Challenges in Epilepsy Care: A Case Based Approach Advances in Epilepsy Management: Challenging Issues and Challenging Populations Medical Grand Rounds General Internal Medicine 2008 Practicing Clinicians Exchange: Stemming the Tide: Timely Intervention to Halt Migraine Progression Graduate Traineeship 5/16/08-5/15/09 Installment Payment Graduate Traineeship 5/16/08-5/15/09 Installment Payment Graduate Traineeship 5/16/08-5/15/09 Installment Payment Graduate Traineeship 5/16/08-5/15/09 Installment Payment Scholarship Award Oncology Fellowship 7/1/08-12/31/08 Support Spring and Fall 2009 Seminar Series on Analytical Chemistry Drug Development Fellowship
University of California San Francisco
University of Cincinnati
University of Florida
University of Maryland School of Medicine
University of Medicine and Dentistry of New Jersey
University of Nebraska Medical Center
University of North Carolina
University of North Carolina
University of North Carolina
University of North Carolina
University of North Carolina at Chapel Hill
University of North Carolina at Chapel Hill
University of North Carolina at Chapel Hill
University of North Carolina at Chapel Hill School of Pharmacy
13
The Medical Management of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome
University of California San Francisco
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
University of North Carolina at Chapel Hill School of Pharmacy Alumni Association University of North Carolina Pharmacy Alumni Association Golf Tournament
$2,500
Support 2009 Workshop Symposium Focused on Innovative and Recent Developments in Technology for Production of Membrane Proteins
$5,000
$50,473
$5,000
$1,000
$28,447
$3,024
$3,024
$3,024
$3,024
$93,750
$1,420
$5,000
$3,000
$2,500
$7,500
$2,500
25th Symposium: Cardiology for the Practitioner
$192,927
$10,000
$20,000
$3,000
$2,500
$45,000
$5,000
$127,028
Amount
Page 457
University of California San Francisco
University of California Regents
University of California Regents
6th Annual New Insights Into Coagulation
Trustees of the University of Pennsylvania
9th Annual University of California San Diego Heart Failure and Hypertension Symposium for Primary Care and Internal Medicine Physicians What to Add After Metformin: Individualized, Effective and Safe Clinical Strategies for Durable Glycemic Control in Patients with Type 2 Diabetes
2008 Executive Management Program for Pharmacy Leaders
Project Description
Trustees of the University of Pennsylvania
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Immunization Update: 2009 Urologic Oncology: Advances in Clinical Practice
University of Southern Nevada
University of Texas System
Vanderbilt Ingram Cancer Center 2nd Annual American Society of Hematology Review Symposium GSK Research & Education Foundation for Cardiovascular Disease Award Program for Young Investigators Award Winner 11th Annual Diabetes Management Conference Advances in Diagnosis and Treatment of Hematologic Malignancies Familial Gastrointestinal Cancer Syndromes: Genetics, Diagnosis, Management and Future Directions Improved Immunization Compliance Summer 2008 Internship 47th Annual Scientific Session Little Bites, Big Steps: Early Childhood Nutrition and Fitness Program Wisconsin Northwood Family Practice Update Fall 2008 Conference Calomiris Health and Fitness Program
Vanderbilt University
Vanderbilt University Medical Center
Wake Forest University Health Sciences
Washington University
Washington University
Wayne State University
West Chester University of Pennsylvania
Western Society of Allergy and Immunology
WHYY
Wisconsin Association of Osteopathic Physicians and Surgeons
Young Mens Christian Association of Metropolitan Washington
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Kay Yow/WBCA Cancer Fund Infrastructure Support
V Foundation
University of Wisconsin System
University of Washington
The 47th Annual University of Southern California Weil Symposium on Critical Care and Emergency Medicine
University of Southern California
The ACCORD Trial: What Did We Learn About Glucose Control in Type 2 Diabetes Related to Total Mortality and Macro Vascular Cardiovascular Disease Events? PeerView Multi Supported in Review, “Human Immunodeficiency Virus, Aging, and Chronic Comorbidities” (PA04830FC)
Educating Physicians in Their Communities: Immunization Program
Project Description
University of Pittsburgh Office of the Comptroller
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
14
$1,000
$2,000
$10,000
$30,000
$540
$20,000
$5,000
$2,500
$3,000
$55,000
$7,500
$100,000
$8,000
$1,255
$2,500
$2,500
$3,000
$12,000
Amount
Page 458
Strategy:
Key Public:
Consumers & Prospects
*Based off 30 second TV ad production expenses. Retrieved October 19, 2009, www.gaebler.com/Television-Advertising-Costs.htm
Evaluation: Consumer Surveys, Target 90% Awareness of GSK Consumer price reductions Evaluation: Reduction in operating and inventory expenses by 7%, of which a 5% in product pricing will be reduced by 5% across all product lines.
Promotional Items: Desktop Toys with Kaizen & Five S Logo, to remind Employees daily of lean business processes
0 na
1 12
60,000
10
na
0
Perpetual
10
300
120
Perpetual
Feb
Perpetual
1
Jan
120,000
4
20,000
Advertising: Posters for Promoting Lean Business Processes, to be display in conspicuous locations within all work areas
Communication: Internal E-mail blast reminders of Kaizen and Five S., 1 Communication per quarter. Training: Kaizen & Five S Certification and Training for all GSK Employees Press Releases: Announce Lean Program focused on achieving 5% in consumer price reductions Press Releases: Announce 7% Price Reduction to Consumers and Prospects
Qnty
Tactics
Corporate-wide cost reduction programs such as leaner manufacturing processes that reduce costs and global outsourcing
na
0
10
Mar
na
0
Perpetual
10
Perpetual
1
Perpetual
Apr
na
0
10
May
na
0
Perpetual
10
Perpetual
Perpetual
June
na
0
10
1
July
na
0
Perpetual
10
Perpetual
Perpetual
Aug
na
0
10
Sept
na
0
Perpetual
100
10
Perpetual
1
Perpetual
Oct
na
0
100
10
Nov
na
1
100
10
Dec
$0
60,000.00
300.00
120.00
4.00
20,000.00
# Runs/Items
$10,000
na
1.00
Corporate-wide cost reduction programs
Grand Total Evaluation of
na
Corporate-wide cost reduction programs
Grand Total Consumer & Prospect
$2
$100
$100
$1,500
$100
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar
GlaxoSmithKline Public Relations Plan & Case Study
120,000.00
# People
BUDGET
na
na
na
na
na
na
na
# Hours/Month/Person
$10,000
$10,000
$180,165,400
$120,000
$30,000
$12,000
$180,000,000
$400
$3,000
Total Expense
Page 459
Strategy:
Key Public:
Consumers & Prospects
*Based off 30 second TV ad production expenses. Retrieved October 19, 2009, www.gaebler.com/Television-Advertising-Costs.htm
Evaluation: Consumer Surveys, Target 90% Awareness of GSK Mother, Infant and Child Prescription and Medical Care Program
Evaluation: 100,000 in offline hands-on training event attendance Evaluation: 1,000,000 in online completion of video training, determined through online registration & course data Evaluation: Training assessment with a passing sore of 80%
Press Releases: Announce 7% Price Reduction to Consumers and Prospects Preferential Pricing: Medical Products & Services for Mothers, prenatal care and infants Print: Assessments and Course Evaluation Cards Training Events: Host Event in large, easily accessible venue, where hands-on prenatal training and infant/childcare healthcare issues are presented Personnel: Event Managers, Labor Hours Personnel: Ground Logistics, Labor Hours Personnel: Creative Team, Labor Hours
Press Releases: Announce Prescription & Medical Care Program specifically designated for Mothers, prenatal care, and infants
Develop or co-found accessibility to medicine programs and other healthcare initiatives through hands-on training. Tactics Advertising: 30 second national television Ad production* Advertising: 30 seconds Air Time, National Television Communication: External E-mail blasts reminders to Patient Advocates 2x per month Event: Display, Equipment, Props, and AV Internet: Dedicated website & Program Registration Portal Internet: Development and Deployment of Internet based synchronous and asynchronous Prenatal, infant and childcare health concerns. Printing: Rx Card & Medical Printing na
10
na 1 120
1
10
Perpetual
10
na Perpetual
2
Perpetual 360
Oct
1
5 20 5
0
0
Perpetual Perpetual Perpetual
0
0
Perpetual Perpetual Perpetual
1
Perpetual
0
0
Perpetual Perpetual Perpetual
1
Perpetual
0
0
Perpetual Perpetual Perpetual
1
Perpetual
0
0
Perpetual Perpetual Perpetual
1
Perpetual
1
1
10
10
na
2
360
Sept
Perpetual
Perpetual
10
Perpetual
10
na Perpetual
2
Perpetual 360
Aug
12
1
10
10
na
2
360
July
1,000,000
Perpetual
10
Perpetual
10
na Perpetual
2
Perpetual 360
June
Perpetual
1
10
10
na
2
360
May
Perpetual
Perpetual
10
Perpetual
10
na Perpetual
2
Perpetual 360
Apr
60,000
1
10
10
na
2
360
Mar
100
10
Perpetual
10
na Perpetual
2
Perpetual 360
Feb
300
120
10
2
24
1,000,000
360
Qnty 10 4,320
Jan
0
1
100
10
10
na
2
360
Nov
1
1
100
10
10
na
2
360
Dec
12.00
1,000,000.00
60,000.00
300.00
120.00
120
1.00 1
24.00
10 4320
# Runs/Items
undetermined
1,000,000.00
# People
BUDGET
Grand Total Evaluation of Develop/co-found Accessibility to Medicines Program
1.00
1,100,000.00 $10,000
$1
12.00 1,000,000.00
$1
$2,500
$35 216.00 5 $20 216.00 20 $25 full-time emp 5 Grand Total Consumer & Prospect Develop/co-found Accessibility to Medicines Program
$10,000
$0
$2
$100
$1,500
$5
$1,500
$20,000 $20,000
$200
$350,000 $175,000
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
na
40 32 1960
na
na
na
perpetual
na
na na
# Hours/Month/Person
$1,090,000
$10,000
$550,000
$500,000
$30,000
$302,400 $138,240 $245,000 $766,110,440
$120,000
$250,000
$120,000
$30,000
$180,000
$5,000,000
$180,000
$20,000 $20,000
$4,800
$3,500,000 $756,000,000
Total Expense
Page 460
Strategy:
Key Public:
Consumers & Prospects
*Based off 30 second TV ad production expenses. Retrieved October 19, 2009, www.gaebler.com/Television-Advertising-Costs.htm
Evaluation: Reach 10,000,000,000 in viewership within 12 months contract Neilson Ratings
Evaluation: 25% of viewers should be attained through introduction of new media such as a dedicated Internet program registration portal; promotion through social media and use propaganda through You-tube. (contract Neilson Ratings)
Evaluation: 75% viewership should be achieved through traditional advertising and public relation methods including outdoor, television and radio. (contract Neilson Ratings)
Tactics Advertising: Internet Banner Ads Advertising: 30 second national television Ad production* Advertising: 30 seconds Air Time, National Television Advertising: Magazines Advertising: Newsprint Advertising: Radio Collateral: Corporate Website Collateral: Leave Behind Brochures Internet: Dedicated website & Program Registration Portal Internet: Promote Patient Programs through Social Media & Viral Marketing on 10 social media sites POS: Point of Sale Display Kiosks, distributed at local Pharmacies. Kiosk allows Mothers to register for services. Personnel: Creative Team
Mass Communication of GSK Patient Programs
Perpetual
20
Perpetual
Perpetual
perpetual
Perpetual
1000 Perpetual 360 40 20 150 Perpetual 834 Perpetual
10
834
360 40 20 150
1000
Feb
100,000
Qnty 1,000,000,000 10 4,320 480 240 1,800 1 10,000 1
Jan
834
360 40 20 150
1000
Mar
Perpetual
Perpetual
Perpetual
Perpetual
1000 Perpetual 360 40 20 150 Perpetual 834 Perpetual
Apr
833
360 40 20 150
1000
May
Perpetual
Perpetual
Perpetual
Perpetual
1000 Perpetual 360 40 20 150 Perpetual 833 Perpetual
June
833
360 40 20 150
1000
July
Perpetual
Perpetual
Perpetual
Perpetual
1000 Perpetual 360 40 20 150 Perpetual 833 Perpetual
Aug
833
360 40 20 150
1000
Sept
Perpetual
Perpetual
Perpetual
Perpetual
1000 Perpetual 360 40 20 150 Perpetual 833 Perpetual
Oct
833
360 40 20 150
1000
Nov
833
360 40 20 150
1000
Dec
50,000.00
perpetual
1,000,000,000 10 4320 480 240 1800 1 10000 1
# Runs/Items
# People
BUDGET
perpetual Grand Total Evaluation of Mass Communication of GSK Patient Programs
$5,000,000
$50 full time emp 20 Grand Total Consumer & Prospect Mass Communication of GSK Patient Programs
$7,500
$250,000
$0 $350,000 $175,000 $15,000 $10,000 $750 $30,000 $3 $20,000
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
na
1960
perpetual
perpetual na perpetual
na na na na na
# Hours/Month/Person
$5,000,000
$5,000,000
$1,960,000 $1,397,740,000
$375,000,000
$250,000
$250,000,000 $3,500,000 $756,000,000 $7,200,000 $2,400,000 $1,350,000 $30,000 $30,000 $20,000
Total Expense
Page 461
Strategy:
Key Public:
Evaluation: 75% Event Attendance, Digital Swipe Card System Evaluation: Quantity of Press Mentions Evaluation: 1,000,000 in Unique Website Visitors
Tactics Collateral: Invitations & Save the Date Reminders Collateral: Digital & Print Press Kits Collateral: Press Releases Event Collateral: Info Kits Events: Host Annual 5-Day Healthcare Summit in March Events: Venue Reservation & Expense Events: Food & Beverages Internet: Event Website Personnel: Speakers Personnel: Event Managers Personnel: Ground Logistics Personnel: Creative Team
Maintain a voice/presence in current healthcare issues through participation in industry organizations, influencing public opinion, and lobbying government leadership. Inform & motivate public of healthcare best practices/approaches
Domestic Regulators, Government, Policy Makers & Lobbyists
count 50 1,000,000
Qnty 1,000 1,000 60 1,000 1 1 1 1 10 10 40 2 0 0 0 2
500 1 20 0 0 0 0
Jan
500 0 20 0 0 0 0 Perpetual 0 0 0 2
Feb
10 10 40 2
0 0 20 1000 1 1 1
Mar
0 0 0 0 0 0 0 Perpetual 0 0 0 0
Apr
0 0 0 0
0 0 0 0 0 0 0
May
0 0 0 0 0 0 0 Perpetual 0 0 0 0
June
0 0 0 0
0 0 0 0 0 0 0
July
0 0 0 0 0 0 0 Perpetual 0 0 0 0
Aug
0 0 0 0
0 0 0 0 0 0 0
Sept
0 0 0 0 0 0 0 Perpetual 0 0 0 0
Oct
0 0 0 0
0 0 0 0 0 0 0
Nov
0 0 0 2
0 0 0 0 0 0 0
Dec
# Runs/Items
na na na na na na na na 10 10 40 2
# People
BUDGET
$20,000 1.00 na $2,500 1 $2,500 1.00 1 Grand Total, Evaluation of Voice in Healthcare Issues & Influence Policy Makers
$5 1,000.00 $3 1,000.00 $15 60.00 $10 1,000.00 $50,000 1.00 $30,000 1.00 $20,000 1.00 $10,000 1.00 $125 1.00 $35 1.00 $20 1.00 $25 1.00 Grand Total, Voice In Healthcare Issues & Influence Policy Makers
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
na na na
na na na na na na na na 40 80 80 163
# Hours/Month/Person
$20,000 $2,500 $2,500 $25,000
$5,000 $3,000 $900 $10,000 $50,000 $30,000 $20,000 $10,000 $50,000 $28,000 $64,000 $8,150 $279,050
Total Expense
Page 462
Corporate Transparency & Accessibility
GlaxoSmithKline Board of Directors, Investors & Shareholders
Evaluation: Event Attendance, Digital Swipe Card System Evaluation: Quantity of Press Mentions Evaluation: Quantity of Shareholder Video Conference Attendees Evaluation: Quantity of Online Executive Chat Participants
Tactics Advertise: Internet GSK Executive Chat Sessions through Direct Mailings Advertise: Annual May Stockholders Meeting, Newspaper WSJ (1/2 Page) Events: Host Annual May Stockholders Meeting & Reserve Venue Events: Beverages & Light Hor Devours for Annual Shareholder Meeting Host: Internet Chat Sessions with Corporate Executives Host: Live & Interactive Video Conference of Annual Shareholders Meeting Mailings: Mail notice/invitation of Annual Stockholders Meeting Press Release: Annual Share Holders Meeting Announcement Publish & Distribute: Annual Report Publish: All Corporate Gifts & Donations(To & From GSK), Website Publish & Distribute: Ballots & Proxies Personnel: Executive Chat Spokesperson Personnel: Event Manager, Annual Shareholder Meeting Personnel: Ground Logistics Personnel: Creative Team
Strategy:
Key Public:
count 50 250 50
0 1 0 0 2
0
0 0 1 0
1 3 5 750,000 1 750,000 12 2 15 2
1 1 0 Perpetual 0 1 0 0 2
1 1 0 0 1
Feb
1 0 0 0 1
Qnty 12 3 1 1 12
Jan
0 1 0 0 2
1 1 0
0
1 1 0 0 1
Mar
1 1 750,000 Perpetual 1 1 0 0 2
0
1 1 0 0 1
Apr
0 1 2 15 2
0 1 0
1
1 0 1 1 1
May
0 0 0 Perpetual 0 1 0 0 0
0
1 0 0 0 1
June
0 1 0 0 0
0 0 0
0
1 0 0 0 1
July
0 0 0 Perpetual 0 1 0 0 0
0
1 0 0 0 1
Aug
0 1 0 0 0
0 0 0
0
1 0 0 0 1
Sept
0 0 0 Perpetual 0 1 0 0 0
0
1 0 0 0 1
Oct
0 1 0 0 0
0 0 0
0
1 0 0 0 1
Nov
0 1 0 0 0
0 0 0
0
1 0 0 0 1
Dec
1.00
12.00 2.00 1.00 1.00 12.00
# Runs/Items
unlimited
750,000 na 500-1000 500-1000 1
# People
BUDGET
$20,000 1.00 $2,500 $2,500 1.00 $2,500 1.00 Grand Total, Evaluation of Corporate Transparency & Accessibility
na 1 1 1
$20,000 $2,500 $2,500 $2,500 $27,500
$1,680 $7,200 $98,000 $15,953,130
24 24 1960
na na na na
$2,250,000 $3,750 $3,750,000 $24,500 $750,000
$15,000
$9,000,000 $20,000 $20,000 $10,000 $3,000
Total Expense
Page 463
na na na 980 na
na
na na na na 2
# Hours/Month/Person
3.00 750,000 5.00 circulation 1.00 750,000 perpetual 1 750,000 cost accounted for in line item above $35 1.00 2 $20 1.00 15 $25 full time 2 Grand Total, Corporate Transparency & Accessibility
$1 $750 $5 $25 $1
$15,000
$1 $10,000 $20,000 $10,000 $125
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Non-Governmental Organizations (NGO's) & Patient Groups
Evaluation: Measure monetary contributions Evaluation: Event Attendance, Entrance Counter & Metal Detector Evaluation: Quantity of Press Mentions Evaluation: Social Media Mentions Evaluation: Quantity of Online Executive Chat Participants
Press Release: Announcement of Event Personnel: Performing Artists Personnel: Executive Spokespersons/Event Hosts-MCs Personnel: Event Manager, Concert Logistics Personnel: Ground Logistics Personnel: GSK Creative Team
Logistics: EMS, Traffic Planning, and Entrance Safety Checks
Community and Healthcare activism and support initiatives of Strategy: NGOs and Patient Groups through monetary contributions and volunteer efforts. Tactics Advertise: Promote Concert through Internet Viral Marketing Advertise: Promote Concert through Internet Social Media Events: Host Outdoor Fund-raising Concert promoting HealthCare Reform Event: Staging, Lighting, AV and Barricade Equipment Grounds: Porta-Johns, Vending Setup, Parking Setup and Breakdown Ticketing: E-Ticket through a volunteer Ticketing Agency Host: Live & Interactive Video Conference of Annual Shareholders Meeting
Key Public:
0 0 0
donations vol. & don. vol. & don. 1
10,000,000 750,000 1,000 5,000,000 50
1,200 100 25 50 300 25
300 0
0
1
50
0
Qnty perpetual 3
Jan
300 0 Perpetual Perpetual Perpetual Perpetual
Perpetual
0
0 0 Perpetual
0
Perpetual 1
Feb
300 0
0
0 0
0
1
Mar
300 100 Perpetual Perpetual Perpetual Perpetual
Perpetual
0
0 0 Perpetual
0
Perpetual 1
Apr
1 100
1
1 1
1
0
May
June
July
Aug
Sept
Oct
Nov
Dec
# Runs/Items
# People
BUDGET
Grand Total Evaluation of Healthcare Reform Rock Concert
Grand Total, Healthcare Reform Rock Concert
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
# Hours/Month/Person
100% Volunteer Project
100% Volunteer Project
Total Expense
Page 464
Non-Governmental Organizations (NGO's) & Patient Groups
Activism and Support of NGOs & Patient Groups
41,667
42
500,000
500
1
12 10
1
120
10
11
Jan
Qnty 120 1
Evaluation: Volunteer count (Measure quantity of volunteers)10% GSK emp. Evaluation: Measure monetary contributions count Evaluation: Press Mentions 50 Evaluation: Case Studies/"My Story" Testimonials 50
Promotional Items: Develop logo and manufacture/purchase an embellishment that may be worn to display support for a given cause. Ex. Lance Armstrong, "Live Strong" arm bracelets
Personnel: Participate through Volunteerism
Leadership: Found/Develop Follow-on Patient Support Group Services Post Illnesses
Tactics Financial: Monetarily Support NGOs through Memberships & Grants Financial: United Way Corporate Matching* Leadership: Host 12 fundraising Events/telethons/encourage donations and pledges Leadership: Host Panel Discussions, Provide Venue & Event Mgmt Services
Strategy:
Key Public:
41,667
42
10
1
1
10 Perpetual
Feb
41,667
42
10
1
1
10
Mar
41,667
42
10
1
1
10 Perpetual
Apr
41,667
42
10
1
1
10
May
41,667
42
10
1
1
10 Perpetual
June
41,667
42
10
1
1
10
July
41,667
42
10
1
1
10 Perpetual
Aug
41,666
41
10
1
1
10
Sept
41,666
41
10
1
1
10 Perpetual
Oct
41,666
41
10
1
1
10
Nov
41666
41
1
1
0
10
Dec
$0
500,000.00
perpetual
120.00
12.00
11.00
120.00 perpetual
# Runs/Items
BUDGET
na
as needed
Appoint Leaders as needed
na volunteers volunteers as needed Select Panel as needed
# People
volunteer work perpetual as willing as provided perpetual as willing $ 2,500.00 perpetual 1 $30 perpetual 1 Grand Total Evaluation of Activism & Support of NGO's & Patient Groups
Grand Total, Activism & Support of NGO's & Patient Groups
volunteer work
$10,000
$20,000
$250,000
$50,000 $1,400,000
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
as willing na 8 20
na
as needed
8
8
as needed
na as willing
# Hours/Month/Person
$ $ $
$125,000
na na 2,500.00 600.00 3,100.00
$11,715,000
-
$1,200,000
$240,000
$2,750,000
$6,000,000 $1,400,000
Total Expense
Page 465
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GlaxoSmithKline Healthcare Reform & Accessibility to Medicines: Public Relations Plan & Case Study
by Jill
Leigh Bullock
Leigh Publishing Publicist & WVU Graduate Student To Learn More About Leigh Publishing Contact [email protected]
www.leighpublishing.com
Case Study & Public Relations Plan provided in conjunction with the Perley Isaac Reed School of Journalism Integrated Marketing Communication Master’s Program at West Virginia University
Integrated Marketing Communications 618: Public Relations Dr. Debra Davenport October 26, 2009
GlaxoSmithKline Public Relations Plan & Case Study
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GlaxoSmithKline Public Relations Plan & Case Study Appendix A: GSK Corporate Responsibility Report, 2008
Do more, feel better, live longer
August 2009 Interim Update Updates to information in our 2008 Corporate Responsibility report published in March 2009 have been inserted into the relevant sections of the report and are highlighted in blue boxes in a similar style to this text.
Our responsibility 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK Tel: +44 (0)20 8047 5000
Source: Retrieved October 24, 2009, from www.gsk.com/responsibility/downloads/GSK-CR-2008-full.pdf
Page 47
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Page 48
Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Corporate Responsibility Report 2008 Contents You have downloaded the full Corporate Responsibility Report 2008.
Corporate responsibility at GSK
3
Research practices
104
Message from the CEO
4
105 106 107 108
Our key issues
10
Emerging technologies – Cloning technology and stem cell research – Genetic research – Collaborative research on emerging technologies
Corporate responsibility governance
11
Animal research
109
13
Human tissue research
115
21
Medical governance
116
23
Clinical research – Planning and approval – Informed consent – Post-trial treatment – Clinical trials in the developing world
117 118 119 120 121
Public disclosure of clinical research
122
Patient safety – Patient safety governance framework – Collecting and reporting safety data – Performance
125 126 127 132 133
Our Corporate Responsibility Principles
6
Business case for corporate responsibility
8
Stakeholder engagement About our reporting Benchmarking Assurance and internal audit
25
Corporate responsibility data summary
27
Resources and downloads
30
Contribution to global health
31
The cost of disease
32
The role of vaccines
33
Treating ill health
35
Disease awareness and prevention
39
Investing in R&D
44
! "#
of research participants
46
Working with healthcare professionals
134
48
Training and auditing
135
Q&As
51
Case studies
138
Q&As
140
Access to medicines
53
Our approach and contribution
55
The role of others Developing countries
57 59
Ethical conduct
142
Code of Conduct and business ethics
143
60 71 73 75 79
Marketing ethics – Relationships with healthcare professionals – Direct-to-consumer advertising Training and awareness – Leading by example – Performance and plans
145 147 151 154 156 157
86
Monitoring and compliance
159
88
Case studies
163
Intellectual property
89
Q&As
165
The future
93
– Research and development – Public-Private partnerships – Product registrations – Preferential pricing – Pricing in middle-income countries Developed countries Pricing our medicines
Response to assurance recommendations
96
Case studies
98
Q&As
101
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.) Corporate Responsibility Report 2008 Contents
Supply chain
167
Responsibility and our supply chain – Human rights clause – Choosing suppliers – Monitoring and engagement – Supplier diversity – Fair treatment of suppliers
168 170 171 172 176 178
Maintaining quality
179
Security of supply
180
Counterfeiting
181
Case studies
184
Q&As
185
Environmental sustainability Plan for excellence – Targets – The journey to sustainability
186 187 188 190
Managing EHS and sustainability – EHSS vision and policy – Training and awareness – Audits and compliance – Reward and recognition – Management of EHSS
192 193 194 196 198 199
Environmental fundamentals – Wastewater – Hazardous and non-hazardous waste – Contaminated land – Emissions to air – EHSS in business processes – Supplier performance
200 201 204 210 211 216 217
Sustainability – Materials – Climate change and energy – Water use – Product stewardship – Packaging Open and transparent relations – Stakeholder engagement – EHSS reporting – Assurance – GSK response to assurance
218 219 221 230 233 240 241 242 243 244 247
Q&As
249
Environmental metrics
250
Our people
255
Our culture and behaviours
257
Restructuring
258
Consultation
259
Communication
260
Diversity and inclusion
263
Training and development
267
Reward and recognition
269
Health, safety and wellbeing – Health and safety management – Hazard assessment and communication – Safety programmes – Health and wellbeing programmes – Health and business continuity – Training and awareness – Performance
270 271 273 275 278 280 281 282
Case studies
288
Q&As
290
Human rights Employees
292 293
Suppliers
294
Communities
295
Society
296
Activities in sensitive countries
297
Public policy and patient advocacy
298
Our approach to external affairs
299
Public policy activity in 2008 – Advocacy on healthcare and disease prevention – Advocacy on research practices – Advocacy on patient safety – Advocacy on intellectual property – Advocacy on pricing and competitiveness
301 302 304 306 307 309
Political contributions and lobbying expenditures
310
Patient advocacy – Transparency – Understanding patients – Developing industry standards – Advocacy in 2008
312 314 315 316 317
Q&As
318
Source: Retrieved October 24, 2009, from www.gsk.com/responsibility/downloads/GSK-CR-2008-full.pdf
GlaxoSmithKline Public Relations Plan & Case Study Appendix A: GSK Corporate Responsibility Report, 2008 (cont.) Corporate Responsibility Report 2008 Contents
Our work with communities
319
Community investment
321
Preventing disease – Eliminating lymphatic – Personal Hygiene And Sanitation Education (PHASE) – Local programmes
323 324 325 326
Building community capacity – Combating HIV/AIDS – Positive Action – Combating malaria – Africa Malaria Partnership – Local programmes – Responding to disasters around the world
327 328 329 330 332
Supporting science education
333
Our plans
335
Source: Retrieved October 24, 2009, from www.gsk.com/responsibility/downloads/GSK-CR-2008-full.pdf
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK
Corporate Responsibility Report 2008 Corporate responsibility at GSK Corporate responsibility (CR) is central to our business. We aim to operate in a way that reflects our values, to understand and respond to stakeholder views and to connect business decisions to ethical, social and environmental concerns. We seek to minimise the negative impacts and maximise the benefits of our business. Read a message from our CEO on the importance of CR at GSK. Every GSK employee is responsible for upholding our values and maintaining high ethical standards. Our Corporate Responsibility Principles define our approach to our key responsibility issues and provide guidance for employees on the standards to which the company is committed. We communicate with our people to underline our commitment to corporate responsibility and to update them on our progress. We also engage with our external stakeholders ± including healthcare professionals, investors, patients, nongovernmental organisations, local communities and suppliers ± to identify key issues and to gain feedback on our approach to corporate responsibility. Our business makes a valuable contribution to society through the medicines and vaccines we produce which improve people¶s lives. However, we know that the research and development, manufacture and sale of medicines and vaccines raise ethical issues. Consequently, the pharmaceutical industry is subject to a high level of public scrutiny and sometimes critical media coverage. We aim for the highest ethical standards and we regularly report on our progress. This is essential for maintaining good relationships with our stakeholders, achieving the goals of our strategic priorities and ensuring the future sustainability of our business. It also supports our inclusion in key sustainability indices such as the FTSE4Good index and Dow Jones Sustainability Index. See how we scored in industry and investor benchmarks. Our Corporate Responsibility Principles define our approach to our key responsibility issues and provide guidance for employees on the standards to which the company is committed. Read about our management structures and processes for advancing progress on our CR Principles. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Message from the CEO
Corporate Responsibility Report 2008 Message from the CEO A new mindset Welcome to GSK¶s Corporate Responsibility report which provides information on our activity and performance during 2008. We want to be a company that is forward looking, innovative and willing to try new approaches and partnerships; a company that is constantly looking for new and sustainable ways to increase access to our medicines and vaccines, especially for those least able to pay. We have made significant progress in helping to address global healthcare challenges. For example, over the past ten years we have donated over one billion tablets to the programme to eliminate lymphatic filariasis, a debilitating tropical disease and we are doubling manufacturing capacity to 600 million tablets a year. Our commitment to preferential pricing means we offer our AIDS and malaria medicines at not-for-profit prices in the world¶s poorest countries. We also supply our vaccines to organisations such as GAVI and UNICEF at preferential prices, typically 10-20 per cent of the prices in developed countries. But for every success story, there are examples of where we could do more. As I review our performance, I believe it is time for a new mindset in our industry and a new contract with society. In these difficult economic times it is a challenge to think beyond short-term performance. But we must look to the long-term and not be distracted by our own economic problems when the needs of the developing world remain just as pressing. To begin with, there are four areas where we can show we are going to do things differently. First, we are exploring a more flexible approach to intellectual property rights to incentivise much needed research into medicines for 16 neglected tropical diseases where there is a severe lack of research. One option is a Least Developed Country (LDC) µpatent pool¶ in to which we would put our relevant small molecule compounds, process patents or other knowledge, and which would allow others access to develop and produce new products. Secondly, on 1 April 2009 we will reduce our prices for patented medicines in the 50 poorest countries in the world, the LDCs, so they are no higher than 25 per cent of the developed world price. Where possible we will reduce our prices further while ensuring we cover our manufacturing costs so this offer is sustainable. We also recognise the challenge in middle-income countries where there is a wide disparity in incomes and ability to pay. Here our intention is to work on a case-by-case basis recognising that there is no µone size fits all¶ solution to improving access to medicines in these countries. Thirdly, we will seek out partnerships and open the doors of our developing world research centre in Spain. We already know what partnership can achieve ± for example, we successfully trialled a malaria vaccine candidate in partnership with the PATH¶s Malaria Vaccine Initiative and the Bill and Melinda Gates Foundation. If we extend this approach the benefits will be huge. Fourthly, working with partners such as NGOs, we will reinvest 20 per cent of the profit we make from selling medicines in LDCs to support the strengthening of healthcare infrastructure in these countries. Our sales in LDCs are relatively low so this profit is limited; initially this funding will amount to 1 to 2 million annually. But by our action we hope to send a signal to all multi-national companies operating in LDCs to join us and make a meaningful change in these countries. In all developing countries we must transform GSK into a local company addressing local healthcare needs. Our Brazilian business is leading the way ± supplying vaccines and sharing technical expertise to help build local capacity. We will not forget that significant healthcare challenges exist in developed countries too. We must work in partnership to create a virtuous circle, where industry gets rewarded for demonstrating genuine innovation,
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
healthcare payers get value-for-money because our medicines save them from high-cost healthcare interventions, and more patients get the medicines they need. Of course, access to medicines is not the only issue that counts. We want GSK to be recognised around the world - by all stakeholders - as a company with the highest ethical standards. We made good progress in 2008. We committed to stopping all corporate political contributions from 2009. Our decision to report more fully on our funding for medical education, patient groups and payments to physicians, will increase transparency and provide reassurance to stakeholders. Reflecting our commitment to animal welfare, we took a voluntary decision to end research in great apes, the highest-order of animals next to humans. It is time for a new mindset in our industry and a new contract with society. With the support of other pharmaceutical companies and partners outside the industry, I believe significant improvements in human health can really be achieved. Andrew Witty, CEO Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Our Corporate Responsibility Principles
Corporate Responsibility Report 2008 Our Corporate Responsibility Principles Our Corporate Responsibility Principles identify our key responsibility issues and provide guidance for employees on the standards to which GSK is committed: Employment practices We will treat our employees with respect and dignity, encourage diversity and ensure fair treatment through all phases of employment. We will provide a safe and healthy working environment, support employees to perform to their full potential and take responsibility for the performance and reputation of the business. Read more about our employment practices. Human rights We are committed to upholding the UN Universal Declaration of Human Rights, the OECD guidelines for Multi-National Enterprises and the core labour standards set out by the International Labour Organization. We expect the same standards of our suppliers, contractors and business partners working on GSK¶s behalf. Read more about our approach to human rights. Access to medicines We will continue to research and develop medicines to treat diseases of the developing world. We will find sustainable ways to improve access to medicines for disadvantaged people, and will seek partnerships to support this activity. Read about our approach in Access to medicines. Leadership and advocacy We will establish our own challenging standards in corporate responsibility, appropriate to the complexities and specific needs of our business, building on external guidelines and experience. We will share best practice and seek to influence others, while remaining competitive in order to sustain our business. Community investment We will make a positive contribution to the communities in which we operate, and will invest in health and education programmes and partnerships that aim to bring sustainable improvements to under-served people in the developed and developing world. Read about our work with communities. Engagement with stakeholders We want to understand the concerns of those with an interest in corporate responsibility issues. We will engage with a range of stakeholders and will communicate openly about how we are addressing CR issues, in ways that aim to meet the needs of different groups while allowing us to pursue legitimate business goals. Read about our stakeholder engagement. Standards of ethical conduct We expect employees to meet high ethical standards in all aspects of our business, by conducting our activities with honesty and integrity, adhering to our CR principles, and complying with applicable laws and regulations. Read about ethical conduct. Research and innovation In undertaking our research and in innovating: We may explore and apply new technologies and will constructively engage stakeholders on any concerns that may arise. We will ensure that our products are subject to rigorous scientific evaluation and testing for safety, effectiveness and quality We will comply with or exceed all regulations and legal standards applicable to the research and development of our products Read more about our research practices. Products and customers We will promote our products in line with high ethical, medical and scientific standards and will comply with all applicable laws and regulations. Read more about our marketing ethics.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Caring for the environment We will operate in an environmentally responsible manner through systematic management of our environmental impacts, measurement of our performance and setting challenging performance targets. We will improve the efficiency of all our activities to minimise material and energy use and waste generated. We aim to find opportunities to use renewable materials and to recycle our waste. Read more about environmental sustainability. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Business case for corporate responsibility
Corporate Responsibility Report 2008 Business case for corporate responsibility Demonstrating that our practices are responsible and ethical benefits the business in the following ways: An improved reputation and greater trust in GSK products The ability to attract, retain and motivate talented people. This is becoming increasingly important as fewer young people in our major markets choose science-based careers Constructive engagement with stakeholders. This helps us to prevent avoidable conflict and identify innovative approaches that benefit GSK and wider society Greater access to markets and the ability to influence healthcare policy through improved relationships with regulators and healthcare payers. Helping governments to increase access to medicines and resolve healthcare challenges is particularly important Greater ability to anticipate and prepare for legislative changes and maintain a competitive advantage Helping to maintain support for the intellectual property system by finding innovative ways to increase access to medicines Reduced costs and more efficient use of resources through increased environmental efficiency
Our business strategy Our business performance and development are driven by three strategic priorities which are supported by our corporate responsibility activities. We believe that corporate responsibility should be managed as part of our overall business strategy and through our day-to-day business operations. For this reason we do not have a separate corporate responsibility strategy at GSK. Corporate responsibility and our strategic priorities
We have established strategic priorities which we believe will increase growth, reduce risk and improve our long-term financial performance: Grow a diversified global business Deliver more products of value Simplify the operating model We believe these priorities will enable us to navigate the coming years more successfully and retain our leading-edge position as a company able to meet patients¶ and healthcare providers¶ needs into the future. Running our business in a responsible way is fundamental to our success and inseparable from our strategic priorities. We want to work in way that reflects our values, seeks to understand and respond to stakeholder views and connects our business decisions to ethical, social and environmental concerns. In this way we aim to minimise the negative impacts and maximise the positive benefits of our business.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Our key issues
Corporate Responsibility Report 2008 Our key issues Our CR reporting is focused on the most material (significant and relevant) issues for our business. The following factors influence our materiality assessment: Our business strategy Our risk management processes. Stakeholder interest, including investor feedback Changes in our business and operations, for example the types of product we produce or the locations in which we operate. Existing and proposed legislation Public opinion and press coverage We have identified the following responsibility issues as most material to GSK: The contribution our core business makes to health through research, development, manufacture and the sale of medicines and vaccines Increasing access to medicines in under-served communities Ethical standards in research and development, and sales and marketing Our environmental impact, particularly climate change Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Corporate responsibility governance
Corporate Responsibility Report 2008 Corporate responsibility governance Our Corporate Responsibility Committee (CRC) of Non-Executive Directors provides high-level guidance on our approach to CR. The CEO and members of the Corporate Executive Team (CET) are accountable for responsible management of the business and participate in CRC meetings. During 2008 the Committee members were Sir Christopher Gent (Chair), Dr Stephanie Burns, Dr Daniel Podolsky, Sir Ian Prosser and Tom de Swaan. The Committee meets three times a year to review our policies and progress on our CR Principles. The Committee reviews our performance against five of our CR Principles annually. These are access to medicines, standards of ethical conduct, research and innovation, employment practices and community investment. Other Principles are discussed at least once every two years. The Committee reports its findings to the Board. Management of corporate responsibility
During 2008 the CRC reviewed GSK¶s activity in a number of areas, including access to medicines, community partnerships, humanitarian donations, employee volunteering, sales and marketing practices, disclosure of funding of medical education and patient advocacy groups, product safety and communication of clinical trial results, R&D on diseases of the developing world, use of animals in research, outsourcing of research, research in emerging markets, reduction of employee numbers through restructuring, employee consultation requirements and employment litigation in the US. The Committee also reviews and signs off the annual performance information published on this website and our annual CR highlights document. To augment GSK's engagement with stakeholder opinion, in March 2009 Sophia Tickell was appointed as an external advisor to the Corporate Responsibility Committee. Sophia is an Executive Director and member of the Leadership team at SustainAbility, a think tank and consultancy that seeks to enhance business engagement with social and environmental concerns. Sophia has extensive experience of constructively challenging companies to increase their understanding of societal expectations and to develop strategies to meet them. She has gained this experience in her work as a journalist in Latin America, through her work in
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
international development and her advocacy work at Oxfam and, most recently, through her direction of the investor-led Pharma Futures dialogues which aim to better align societal and shareholder value. Sophia will attend the meetings of the Corporate Responsibility Committee and advise the company in this capacity. Read more about the Corporate Responsibility Committee. Corporate responsibility risks Our Risk Oversight and Compliance Council (ROCC) coordinates the management of significant business risks. The ROCC also considers reputational and corporate responsibility risks. Read more about risk management and compliance at GSK. Management structure CR covers a very diverse range of issues at GSK so we believe it should be managed within our business functions, where the relevant subject experts work. We have a cross-functional team made up of representatives from key business areas which oversees development, implementation and communication of policies, including any responsibility elements, across GSK. The members are senior managers with direct access to our Corporate Executive Team. We have a small central CR team to coordinate policy development and reporting specifically with respect to CR, and to communicate with socially responsible investors and other stakeholders. Measuring performance We have established metrics and key performance indicators to track our performance on responsibility issues. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Stakeholder engagement
Corporate Responsibility Report 2008 Stakeholder engagement Stakeholder engagement and dialogue enables us to connect with the views and opinions of the societies in which we operate. It helps us identify important issues and shape our responses in the interest of our shareholders and wider society. Regular engagement means we are better informed of emerging and current issues and changing societal expectations. It provides an opportunity for us to voice our approach to responsibility issues, obtain important feedback and build trust. Most of this discussion takes place in the normal course of business. For example, our scientists regularly meet academics, researchers and other pharmaceutical companies through advisory boards and medical conferences. Here we describe how we engage with our stakeholders, give examples of our engagement in 2008 by stakeholder group and provide information on how we are responding to the feedback we receive. You will find further examples of our engagement with stakeholders throughout this website.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Stakeholder engagement How we engage
Corporate Responsibility Report 2008 How we engage Healthcare professionals We engage with healthcare professionals in many ways, including through our sales representatives and when running clinical trials. Read about our research and ethics policies governing relationships with healthcare professionals. Patients GSK researchers and scientists meet patients as part of our µFocus on the Patient¶ initiative. This engagement influences our understanding of diseases and our research priorities, read more in our case study.We also support the work of patient advocacy groups and we conduct market research via third parties to understand patient needs. Governments and regulators We engage in debate on legislation and seek to influence policy decisions that affect GSK. We also engage with governments on responsibility-related issues. Healthcare providers We engage with healthcare providers through our government affairs, marketing and access to medicines activities. Investors We meet regularly with investors and socially responsible investors. Read more about our investor engagement activities. Employees We seek feedback from our employees through regular surveys. We also consult employees on changes that affect them and discuss business developments through regional and national consultation forums. Local communities Our interactions with local communities are managed by individual GSK sites. Read more about our financial and practical support for communities . Multilateral agencies We engage with multilateral agencies through our access and public health initiatives. Non-governmental organisations (NGOs) We engage with international and local NGOs through our access , education and public health programmes and as part of our public policy work. We also engage regularly with animal welfare organisations. Read more about animal research at GSK . Scientific community and academic partnerships It is important for GSK to be part of scientific debates and we are involved in a number of academic collaborations. Suppliers We hold global and regional supplier review meetings where senior GSK managers address and interact with suppliers on key issues. Read more about our engagement with suppliers. Peer companies We engage with peer companies through membership of pharmaceutical industry organisations, for example
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
g g p p g p p EFPIA, PhRMA, and IFPMA, and through collaboration on specific projects.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Stakeholder engagement Engagement with employees
Corporate Responsibility Report 2008 Engagement with employees It is important that our employees know about our commitment to corporate responsibility, understand their responsibilities and keep up-to-date with our progress. Read about our approach to embedding an ethical culture at GSK. We keep employees informed about corporate responsibility through our myGSK intranet site and Spirit, our internal quarterly magazine, which feature articles on responsibility issues. Read about how we engage with employees on environment, health and safety issues. In 2008 at least nine articles on responsibility issues were published in Spirit. These included articles on environmental sustainability, community investments and our efforts to combat diseases of the developing world such as lymphatic filariasis. This year we published four editions of Spirit, distributing 33,500 copies of each edition internally. Additionally, during the year, an online version of the magazine was introduced on the intranet, offering access to more employees. We distributed our 2007 Corporate Responsibility Review with Spirit magazine and directly to the Corporate Executive Team and GSK Board, senior managers, site directors and all communications staff. News articles and icons on our intranet site were used to guide users directly to the Review. This year we have published a shorter CR Highlights document to direct people to this website. We are raising awareness of this online CR Report by publicising it on our website and the company intranet.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Stakeholder engagement Engagement with investors
Corporate Responsibility Report 2008 Engagement with investors We held 20 meetings with investors in 2008 to discuss responsibility issues. These comprised one-to-one meetings and teleconferences, and a socially responsible investment (SRI) roadshow.
Investor questions Some of the questions raised by investors about responsibility issues in 2008 concerned: Access to medicines Clinical trial results disclosure Clinical trials in the developing world Patient safety Our operations in sensitive countries. Read more about GSK¶s position on human rights Sales and marketing practices. Read more about marketing ethics at GSK Stem cell research Animal research including genetic engineering of animals Environmental issues including climate change and water pollution Political contributions We also disclose information on our greenhouse gas emissions through the Carbon Disclosure Project (CDP), an investor collaboration.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Stakeholder engagement Engagement with opinion leaders
Corporate Responsibility Report 2008 Engagement with opinion leaders Ipsos MORI survey GSK participated in the Ipsos MORI survey which rates companies according to CR experts¶ and NGOs¶ perception of their CR performance. In 2008 nearly three-quarters of the 41 people surveyed thought that GSK took its responsibilities seriously, maintaining the significant improvement made in 2007 compared with 2006. GSK was the seventh-highest rated company on this question (out of 26 companies). Three of 41 respondents spontaneously mentioned GSK as a leader in corporate responsibility; there were no spontaneous mentions of GSK last year. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corperate Responsibility at GSK Stakeholder engagement Engagement on access to medicines
Corporate Responsibility Report 2008 Engagement on access to medicines Engagement on issues relating to access to medicines during 2008 is described in the Access to medicines section. As well as the engagement during 2008, GSK conducted three formal stakeholder discussions during 2007 to get feedback on our approach to different issues relating to access to medicines . We engaged with influential individuals and organisations with expertise in this area, including NGOs, government representatives, journalists, academics, investors and industry organisations. The topics covered were: Increasing access to HIV/AIDS medicines in developing countries Expanding R&D into diseases of the developing world Increasing access to medicines in middle-income countries While we do not necessarily agree with all the comments made by participants, these sessions provided valuable feedback on our approach. Feedback on GSK¶s approach in developing countries Participants felt that GSK has a moral responsibility to make its products accessible to poor people and that access to medicines is also important to GSK¶s long-term business sustainability. It was felt that GSK¶s approach to increasing access in developing countries (R&D, preferential pricing and voluntary licensing) is appropriate, although participants would like GSK to invest more in R&D into diseases of the developing world and do more to remove obstacles to the supply of generic medicines in these countries. Participants urged GSK to collaborate more with other pharmaceutical companies to address access issues in developing countries. It was felt that an industry-wide approach could help to address issues more quickly and effectively. Feedback on GSK¶s approach in middle-income countries, Participants emphasised the importance of increasing access to medicines in middle -income countries (MICs) where there are still large numbers of very poor people. They encouraged GSK not to treat MICs as we would high-income countries. Participants felt that GSK does not have a clear strategy on access in MICs. They would like GSK to be clearer on its approach and objectives; in particular they would like to know if we regard MICs as significant commercial markets. It was pointed out that chronic diseases are a growing problem in MICs. It was suggested that GSK take a broad approach to access that encompasses all its medicines, not just those for high-profile diseases such as HIV/AIDS, malaria and TB. Read about the findings from these session in more detail.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility CR at GSK Stakeholder engagement Engagement on EHS
Corporate Responsibility Report 2008 Engagement on EHSS We have an Environment, Health and Safety and Sustainability Stakeholder Panel in the UK which has provided independent feedback on our performance since 2005. The panel of 13 members represents customers, suppliers, regulators, public interest groups and investors. Two senior EHSS representatives from GSK regularly participate and other GSK managers attend discussions on specific topics. The panel is facilitated by The Environment Council, an independent charity. The panel met in April and October 2008 to debate a range of issues including: The broad issue of sustainability GSK¶s position on nanotechnology Progress with climate change, process safety and green chemistry programmes GSK¶s plans for complying with the EU¶s Registration, Evaluation and Authorisation of Chemicals (REACH) legislation, mass efficiency improvement and pharmaceuticals in the environment We have been using the feedback from the stakeholder panel to inform our Environment, Health and Safety and Sustainability programme. The panel is also providing input to the new GSK Sustainability Council composed of senior managers from across GSK. Panel members provided feedback about the direction the panel should take and the effectiveness of the dialogue. They proposed that the panel should have a broader geographic reach. We have therefore added three new European panel members and are recruiting two more. The panel finds GSK honest and open in the discussions so they consider their participation to be valuable. However they commented that it takes GSK a long time to demonstrate changes that occur as a result of their suggestions and feedback. We value the feedback we receive from the panel and we will look for ways to speed up our response to their recommendations. Many of our sites also engage with stakeholders locally on EHSS issues, through activities such as open days, newsletters and community projects.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK About our reporting
Corporate Responsibility Report 2008 About our reporting Welcome to our 2008 Corporate Responsibility Report. This year we have reported on our activities and performance online, providing easy access to information on key issues plus the ability to build a custom version of our 2008 Report.
How we report We report our corporate responsibility activities and performance annually. This website contains a detailed account of our CR policies and performance in 2008. Selected performance information can also be downloaded, read more about how to use this website. We also publish Corporate Responsibility Highlights which provides an overview of our approach to CR. It is available in print. Data relate to worldwide operations for the calendar year 2008, except where stated. Environmental data are collected from all 79 of our Pharmaceutical, Consumer Healthcare and Nutritionals manufacturing sites, 14 of the 15 vaccines sites (one is not yet in operation), 22 of 31 Pharmaceutical and Consumer Healthcare R&D sites including five whose environmental data are included with their host sites (nine are too small or too new to warrant collection of environmental data in 2008), the US and UK headquarters buildings and 15 smaller offices and distribution centres. Injury and illness data are collected from all 79 of our Pharmaceutical, Consumer Healthcare and Nutritionals manufacturing sites, 14 of the 15 vaccines sites (one is not yet in operation), 29 of 31 Pharmaceutical and Consumer Healthcare R&D sites (two are considered too new to start reporting), the US and UK headquarters sites, 18 offices and sales groups with more than one million hours worked, and 46 of the smaller offices and distribution centres. Data in the environment and health and safety sections are independently assured by SGS. We use external guidelines to inform our reporting where relevant. We do not base our report on the Global Reporting Initiative (GRI) guidelines but we have produced a GRI index to show which elements of the guidelines are covered in the report and to aid comparison with other company reports. We have also joined the UN Global Compact and have provided an index to show how we are reporting in line with Global Compact expectations. Brandnames appearing in italics throughout this report are trademarks either owned by and/or licensed to GSK or associated companies.
Contact We welcome your feedback on any of the information contained in this report. Please contact us at: Corporate Responsibility GlaxoSmithKline plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom [email protected]
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Benchmarking
Corporate Responsibility Report 2008 Benchmarking GSK received the following ratings from benchmarking organisations:
Indexes Organisation:Access to medicines index - Access to Medicines Foundation and Innovest Strategic Value Advisers Rating: GSK was ranked highest in the index which assessed companies¶ contribution to improving access to medicines. GSK was the clear overall leader and was top in five of the eight categories assessed. Organisation: Dow Jones Sustainability Index Rating: GSK continued as a member of the Dow Jones Sustainability Index, which covers the top ten per cent of sustainable companies in each sector. GSK was awarded Silver Class and Sector Mover distinctions, improving from Bronze Class awarded in 2007. Classes are awarded to companies relative to the sector leader. Organisation: FTSE4Good Rating: GSK was included in the FTSE4Good Index. Organisation: Global 100 Most Sustainable Corporations - Innovest Strategic Value Advisors Rating: GSK was included in the 2009 list of the µGlobal 100 Most Sustainable Corporations¶. Companies are selected because they demonstrate capacity to address sector-specific environmental, social and governance risks and opportunities. Organisation: Business in the Community - CommunityMark Rating: GSK was one of 21 companies and the only manufacturing company to be awarded the new CommunityMark, following independent assessment, for outstanding community investment. The Mark is endorsed by the UK government and voluntary sector leaders and was given for our work at local and national level in the UK as well as for our larger international programmes. Organisation: Business in the Community - Environment Index Rating: GSK maintained its position in the Platinum League of the 2007 index which assessed 155 companies.
Other investor ratings Organisation: Ceres Rating: GSK was ranked 13th overall and 2nd in the pharmaceutical sector in Ceres¶s climate change governance ranking of 63 of the world¶s largest companies.
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Organisation: Storebrand Rating: GSK achieved Best in Class status for its leading environmental and social performance. Storebrand assesses indicators including corporate governance, marketing ethics, standards for business partners, occupational health and safety, environmental risk management and labour relations.
Reporting Organisation: Association of Chartered Certified Accountants (ACCA) Rating: GSK Corporate Responsibility Report 2007 was shortlisted for an ACCA award, which recognises transparency and credibility in reporting. Organisation: PwC Building Public Trust Award Rating: GSK was one of three companies short-listed for the µPeople Reporting¶ award, which assesses the extent to which publicly available information enables stakeholders. Organisation: SustainAbility Global Reporters benchmark Rating: GSK¶s 2007 report scored 66 per cent versus 54 per cent for the 2006 report, with improvements in every category and particularly accessibility and assurance. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Corporate responsibility at GSK Assurance and internal audit
Corporate Responsibility Report 2008 Assurance and internal audit External assurance of EHS activities The information we provide about environment, health and safety activities at GSK has been externally assured by independent, third-party assurers. Our reporting on environment, health and safety performance is assured by SGS, an external assurer. The assurance process includes verification of key environment, health and safety data through site visits and telephone calls to EHS professionals and review of systems and processes for collecting, collating, analysing and interpreting the data. Read the EHS assurance statement by SGS.
External assurance of access to medicines activities In our 2007 CR Report, information on access to medicines was externally assured. Read how we are responding to the recommendations made by the assurers on our access to medicines activity and reporting. This year we did not conduct assurance on the CR report other than that described above for the EHS section. We plan to conduct assurance of one new section of the report every other year, so a section of the 2009 report will be subject to external assurance.
Internal audit and assurance GSK has developed an assurance programme that provides a holistic assessment of internal control processes, risk management and audit within the company. A key part of this programme is an extensive and independent internal audit schedule, delivered by four specialist audit groups. These audits assess compliance with laws, regulations and company standards, and evaluate the effectiveness of the risk management process in identifying, managing and mitigating the more significant risks facing GSK. Global Internal Audit (GIA) is responsible for evaluating the financial and operational controls that ensure financial reporting integrity and safeguard assets from losses, including fraud Corporate Environment, Health, Safety and Sustainability (CEHSS) is responsible for assessing the management of health and safety risks and environmental impacts Global Manufacturing Supply Audit and Risk Management (ARM) assesses the quality and supply risks relating to manufacturing and supply chain processes for GSK commercial products Global Quality and Compliance (GQC) is responsible for assessing risks relating to medicines, vaccines and medical devices throughout the product development process, including the manufacture of clinical trial material The central assurance function is responsible for developing the assurance programme, and for ensuring that the GSK audit groups work together in the most efficient and effective way to deliver the audit schedule. Global Internal Audit audits the other three audit groups for alignment with the Institute of Internal Auditors¶ International Standards for the Professional Practice of Internal Auditing. The CEHSS, ARM and GCQ audit groups have additional responsibilities for the auditing of contract manufacturers and key suppliers to GSK. GSK employs approximately 150 full-time internal auditors across the four audit groups. Audits range in duration from two man-weeks for simple activities where the scope is limited, to several months for an audit involving complex or highly technical processes. The audit teams may also be supplemented by external
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
g p g y p y pp y experts with specific technical skills, or by the use of guest auditors from within the business. Audits are conducted based on the level of risk. They regularly assess the level of internal control for a number of responsibility areas, including: Animal research Business continuity planning Community investment Conduct of clinical trials Employment practices Environmental factors Ethical conduct Financial processes Health and safety Information technology Intellectual property Interactions with patient groups Manufacturing and supply chain standards Patient safety Sales and marketing practices When issues or control deficiencies are identified, the audit groups recommend processes for improvement. GSK managers develop corrective action plans to eliminate the causes of non-compliance and gaps in internal controls. The audit groups track these plans to completion and report results to senior management and the Audit Committee. Each audit group reports to the Audit Committee as part of the assurance programme, and provides an assessment of whether adequate controls are in place to manage significant risks. Any significant audit results are also reported to the Audit Committee at the earliest opportunity. Back to top
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Home Responsibility Corporate responsibility at GSK Corporate responsibility data summary
Corporate Responsibility Report 2008 Corporate responsibility data summary Metric
2004
2005
2006
2007
2008
Number of countries supplied with GSK preferentially priced ARVs 1
57
56
51
31
37
Number of Combivir and Epivir tablets shipped (millions)
66.4
126.3
86.3
85.0
70.0
-
-
120
183
279
0.65
0.65
0.65
0.54
0.54
Voluntary licences granted to generic manufacturers for GSK ARVs (cumulative total) 3
6
7
9
9
9
Value of products donated through GSK Patient Assistance Program in the US ( millions, 2008-2007 at cost, 2006-2004 at wholesale price (WAC)) 4
203
255
200
45
56
Expenditure on R&D ( billions)
2.9
3.1
3.5
3.3
3.7
GSK animal research facilities accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (cumulative total) 5
10
10
10
10
10
Number of trials published on the GSK Clinical Study Register (cumulative total)
143
2,125
2,760
3,089
3,273
Number of employees completing certification to the GSK Code of Conduct
9600
>12,000
>12,000
>14,000
>14,000
Number of contacts through our ethics compliance channels 6
2580
3644
5363
5265
3812
35
35
36
37
38
19.5
19.6
19.8
20.1
20.5
Access to medicines
Number of generic ARVs supplied under licence from GSK (millions) GSK Combivir not-for-profit price ($ per day) 2
Research and Development
Ethical conduct
Employment Women in management grades (%) Ethnic diversity - people of colour (US, %)
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Ethnic diversity - ethnic minorities (UK, %)
14.8
14.9
18.3
19.1
19.2
Lost time injury and illness rate (cases per 100,000 hours worked)
0.32
0.32
0.34
0.35
0.33
Number of contract manufacturers audited
35
41
36
55
53
Energy consumption (million gigajoules)
19
19
19
19
19
Water consumption (million cubic metres)
21
22
22
21
20
Ozone depletion potential from metered dose inhalers (tonnes CFC-11 equivalent) 7
464
273
182
136
88
Ozone depletion potential from production (tonnes CFC-11 equivalent)
59
51
33
15
5
Ozone depletion potential from refrigeration and other ancillary uses (tonnes CFC-11 equivalent)
3
3
1
1
<1
Volatile organic compound emissions (thousand tonnes)
5
5
4
4
4
Global warming potential from energy sources (thousand tonnes CO 2HTXLYDOHQW 8
1,667
1,717
1,704
1,702
1,722
Hazardous waste disposed (thousand tonnes)
71
67
70
72
54
Total community investment expenditure ( millions, 2008-2007 at cost, 2006-2004 at wholesale price (WAC)) 4
328
380
302
109
124
Value of humanitarian product donations, including albendazole ( millions, 2008-2007 at cost, 2006-2004 at wholesale price (WAC)) 4
57
41
38
7
12
Number of albendazole tablets donated for prevention of lymphatic filariasis (millions)
67
136
155
150
266
Environment
Community investment
1. Includes ARVs sold at not-for-profit and discounted prices. We are unable to collect data for the number of patients treated. 2. Includes freight and delivery costs. The Mpdecins Sans Frontiqres pricing report lists the average cost of generic equivalents. 3. Only eight are currently in force. 4. 2008 and restated 2007 figures reflect value at cost (average cost of goods) rather than wholesale acquisition price (WAC). This is the first year we have valued our donations this way and believe it is a more accurate reflection of the true cost to GSK and is therefore more transparent. 2004 to 2006 figures remain at WAC. 5. This covers over 90 per cent of the animals housed in GSK-owned laboratories. 6. Includes contacts with line managers, compliance officers, our confidential Integrity Helplines or offsite
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
post office box (in the US). 7. 2004 data do not include inhalers made in Asia. 8. Climate change impact is calculated as CO 2 equivalent using the Greenhouse Gas Protocol developed by the World Resources Institute and the World Business Council for Sustainable Development. Each year we review the CO 2 factors and update the data for all years as appropriate. The greatest changes are generally in the updated factors for electricity. Back to top
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Home Responsibility Corporate responsibility at GSK Resources and downloads
Corporate Responsibility Report 2008 Resources and downloads Reporting 2008 Corporate Responsibility Report Commitment to transparency and access Corporate Responsibility Highlights 2008 (PDF 325Kb) GRI Index (PDF 103Kb) Global compact index (PDF 24Kb) Corporate responsibility data summary Environmental metrics Archive reports
Additional resources Access to medicines Briefing paper: Access to medicines (PDF 46Kb) Findings from stakeholder engagement sessions: GSK access to HIV medicines workshop (PDF 63Kb) GSK DDW workshop findings (PDF 68Kb) GSK MIC workshop findings (PDF 87Kb) Ethical conduct GSK Code of Conduct (PDF 89Kb) Employee Guide to Business Conduct (PDF 4.3Mb) GSK European Promotion of Medicines Code of Practice (PDF 450Kb) Human rights Human rights statement (PDF 30Kb) Public policy and patient advocacy Our Public policy position statements Details of relationships with patient groups Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Contribution to global health
Corporate Responsibility Report 2008 Contribution to global health How we respond to society¶s healthcare needs is the most important responsibility issue for GSK. It is also central to our commercial success. Ill health and disease continue to place a huge burden on society: from the AIDS epidemic in Africa and Asia to the health needs of an ageing population in the developed world and the huge global growth in chronic diseases such as diabetes. Emerging diseases such as pandemic flu pose potentially serious threats. Ill health is also expensive: it can increase healthcare costs and reduce economic productivity. Our business makes a significant contribution to society by bringing products to market that address the medical needs of patients around the world. We make a contribution in four key areas: Preventing disease: we are one of the world¶s largest producers of vaccines for diseases prevalent in developed and developing countries. We also prevent disease through our community investment, disease awareness work and our over-the counter products Treating ill health: many of our products treat diseases that place a high burden on society Investing in R&D: our pipeline includes new medicines and vaccines that are needed in developing and developed countries Contributing to scientific understanding: we participate in partnerships that advance scientific knowledge and lay the ground for future medical advances We believe that while our business makes a significant contribution to society, there is more we can do. We are looking at ways to accelerate research into neglected diseases by sharing research resources and findings with other organisations and expanding our partnerships with governments, NGOs and other pharmaceutical companies. We also want to partner with others to support delivery of healthcare services as well as medicines. Our products are only beneficial if they are accessible and affordable to healthcare payers and patients. Read about our efforts to increase access to our key products in developing and developed countries and how we support healthcare programmes through community investment. Back to top
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Home Responsibility Contribution to global health The cost of disease
Corporate Responsibility Report 2008 The cost of disease Ill health is expensive for the individual and for society. It is often a result of poverty but it is also an important cause of poverty. For patients it can mean loss of quality of life, loss of earnings and shortened life expectancy. It can place a great burden on families ± for instance the need to care for sick relatives can reduce attendance at school or work. For governments, employers and taxpayers it can mean increased healthcare costs and loss of workforce productivity. In Africa and parts of Asia, AIDS has had a serious effect on social and economic development, undermining progress towards the Millennium Development Goals and poverty reduction efforts. The World Bank estimates that the deaths of working age adults from HIV/AIDS may subtract one per cent a year from GDP economic growth in some sub-Saharan African countries. In South Africa HIV/AIDS may depress GDP by as much as 17 per cent over the next decade 1. Malaria is estimated to cost African nations at least $12 billion a year in lost economic output 2. The economic cost of TB-related deaths, including HIV co-infection, in subSaharan Africa is estimated at $519 billion between 2006 and 2015 3. Read about our research into diseases of the developing world and our efforts to help people in these countries access essential medicines and vaccines . According to the US government¶s Centers for Disease Control and Prevention (CDC), the costs of chronic disease in the US alone include 4: $174 billion a year in direct and indirect costs due to diabetes $81 billion in annual medical care costs for arthritis, and total costs including medical care and lost productivity of almost $128 billion $448 billion projected cost for 2008 for heart disease and stroke Read about how we are working in partnership in the US to combat chronic disease and the role of our vaccines in preventing disease. 1. 2. 3. 4.
www.who.int/trade/glossary/story051/en/index.html Rollback Malaria http://rbm.who.int/globaladvocacy/pr2007-11-29.html http://www.who.int/mediacentre/news/releases/2007/pr64/en/index.html www.cdc.gov/nccdphp/overview.htm
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Contribution to global health The role of vaccines
Corporate Responsibility Report 2008 The role of vaccines Vaccines play a major role in preventing and eliminating disease. Immunisation is acknowledged by the World Health Organization (WHO) as being µamong the most costeffective of health investments¶. Immunisation programmes make a substantial contribution to the aims of the United Nation¶s Millennium Development Goals for economic growth. It is estimated that at least three million deaths are prevented and 750,000 children are saved from disability due to vaccines every year 1. The number of deaths in Africa from measles fell 91 per cent between 2000 and 2006 due to better coverage of routine immunisation programmes and targeted campaigns to ensure that children had a second chance to be vaccinated 2. Despite this progress vaccines are under-used. It is estimated that the lives of over two million children could be saved each year if existing vaccines were made accessible to all who need them. This will require sustained financing and the development of innovative vaccination programmes. GSK is among the world¶s top vaccine providers. We have over 30 vaccines approved for marketing and over 20 in our R&D pipeline, one-third of which target diseases particularly prevalent in the developing world. GSK vaccines are included in immunisation campaigns in 169 countries worldwide. Over 1,600 scientists work in vaccine research at GSK and we believe our vaccine pipeline is the largest in the industry. We remain committed to researching and developing vaccines for all three WHO infectious disease priorities, tuberculosis, HIV and malaria. Together with the PATH Malaria Vaccine Initiative, in 2008 we demonstrated in phase ll trials significant protection against malaria for infants and young children with GSK ¶s RTS,S candidate vaccine. Read more about the malaria vaccine. In 2008 we supplied 1.1 billion vaccine doses. Of these, nearly 80 per cent were shipped for use in developing countries. Read about our tiered pricing system for vaccines. Our vaccine portfolio addresses the medical needs of developing and developed countries. Our portfolio covers most of the leading causes of childhood mortality, as defined by the World Health Organization. Our vaccine range includes products that protect against the following diseases: Cervical cancer
Pneumococcal disease
Chickenpox
Polio
Diphtheria
Rotavirus
Hepatitis A and B
Rubella
Measles
Seasonal influenza
Meningitis
Tetanus
Mumps
Typhoid
Pandemic influenza
Whooping cough (Pertussis)
1. Ehreth J. The Global Value of Vaccination. Vaccine (2003); 21 (7-8):596-600 2. Progress in Global Measles Control and Mortality Reduction, 2000-2006
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www.who.int/wer/2007/wer8248.pdf Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Contribution to global health Treating ill health
Corporate Responsibility Report 2008 Treating ill health We help to treat ill health by developing medicines and consumer healthcare products. We are also working with governments and employers in the US to find innovative ways to reduce the impact of chronic diseases. Our pharmaceutical products target diseases in the following areas: Anti-bacterials (antibiotics) and anti-malarials: infections, malaria Anti-virals: HIV/AIDS, herpes, hepatitis B, influenza Cardiovascular: heart failure, hypertension, deep vein thrombosis Central nervous system: migraine, epilepsy, anxiety, depression, Parkinson¶s disease, smoking cessation, anaesthesia, analgesia, anti-emetics Dermatology: eczema, dermatitis, psoriasis Metabolic: diabetes, osteoporosis, obesity Oncology: breast, cervical, lung and ovarian cancer, non-Hodgkins lymphoma, leukaemia, idiopathic thrombocytopaenic purpura Respiratory and immuno-inflammation: asthma and chronic obstructive pulmonary disease, rhinitis, postoperative ileus Urogenital: prostatic hypertrophy, over-active bladder We also make vaccines which prevent serious diseases. Our products help to improve health in a number of ways: Prolonging life ± our anti-retrovirals (ARVs) such as Combivir help patients to control the effects of HIV infection for many years. We sell our ARVs to the Least Developed Countries and to countries in subSaharan Africa at not-for-profit prices. Read more about our efforts to increase access to medicines Preventing complications ± many diseases such as diabetes are progressive if patients do not receive the right treatment they can suffer severe complications. For example, every day in the US diabetes is the cause of an estimated 225 lower limb amputations, up to 66 cases of blindness, and 117 people experiencing kidney failure. Avandia, our diabetes treatment, helps patients to control their symptoms, delays the progression of the disease and prevents complications. Avandia has now been used by more than seven million people worldwide. Improving quality of life ± many of our medicines such as those for asthma and diabetes help patients with chronic diseases live full and productive lives. GSK preventative treatments for asthma such as Seretide/Advair control the symptoms of asthma and prevent asthma attacks Curing infection ± we produce antibiotics that treat respiratory tract and other infections. We donate antibiotics to help relief efforts in disaster areas Paracetamol
Paracetamol is widely used as a low-cost medicine for treating adult and child pain and fever, and is listed as one of the World Health Organization¶s essential medicines. GSK produces ten billion tablets each year of our over-the-counter paracetomol product, Panadol, which
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
is available in more than 85 countries. This includes low- and middle-income countries, where we provide more affordable low-cost single-dose packs. Medical guidelines across the globe recommend paracetamol, the medicine in Panadol, as the first-line oral painkiller for chronic diseases such as osteoarthritis due to its efficacy, safety profile and costeffectiveness. It is also a first-choice treatment for other conditions such as headache, backache and children¶s fever. Paracetamol is the recommended treatment for the symptoms of dengue fever, a debilitating and lifethreatening disease that is transmitted by mosquitoes in tropical and sub-tropical regions. More than 2.5 billion people are at risk for infection ± two-fifths of the world¶s population ± in over 100 countries. Read about our efforts to increase awareness of dengue fever and correct treatment
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Home Responsibility Contribution to global health Treating ill health Partnering to combat chronic disease
Corporate Responsibility Report 2008 Partnering to combat chronic diseases Healthcare costs in many countries are a concern for patients, healthcare payers and the pharmaceutical industry alike. The increase in prevalence of many chronic diseases such as asthma, diabetes and heart disease is a major contributing factor. We are working with governments and employers to find new ways to address the problem of chronic diseases while reducing healthcare costs. Our approach, known as the µtriple solution¶, has three focus areas: Prevention ± addressing the causes of chronic diseases, such as obesity and smoking, poor diet and lack of exercise Intervention ± properly managing chronic diseases to prevent complications, avoid hospitalisation costs and reduce time away from work Innovation ± developing new treatments for costly unmet medical needs such as Alzheimer¶s disease and stroke
Working with employers and communities In the US, healthcare is a major source of expenditure for the government, employers and consumers. In 2006, expenditures in the US on healthcare exceeded $2 trillion. Additionally, absence from work due to ill health can be a significant cost that often goes unrecognised. We work closely with state and local public health agencies and a large number of employers across the US to help them create health management programmes that remove barriers to healthcare access, reduce healthcare costs and improve health. Our organisation has worked with more than ten states, five municipalities and 200 employers to: Help address some of the diseases that put a great burden on healthcare budgets Encourage employers to provide preventative services to workers, for example, regular health screening to detect early signs of disease, awareness campaigns and initiatives to help employees adopt a healthy lifestyle. Develop disease management programmes which help employees control their symptoms and stick to their treatment regimens Initiate comprehensive wellness initiatives for obesity and smoking, for which we have leading products. Smoking is the leading cause of death and disease in the United States. The direct and indirect costs associated with being overweight and obese are estimated to exceed $100 billion per year in the US, approximately nine per cent of annual medical expenditures. We may advise employers to create new incentives for better health management, for example by reducing the co-pay element of prescription medicine charges. This can increase the total amount employers pay for pharmaceuticals in the short term. However, by improving patient medication adherence rates, it can prevent costly complications and time away from work in the longer term, and so help to lower overall healthcare costs.
The Diabetes Ten City Challenge
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Each day in the US, diabetes causes an estimated 225 lower limb amputations and up to 66 people to lose their sight. However, with the right treatment many of these complications can be prevented. The Diabetes Ten City Challenge, supported by GSK, is a partnership of city governments and private employers in ten cities, the American Pharmacist Association (APhA) Foundation and pharmacists. It helps employees with diabetes manage their condition through nutrition and medication and by adopting a healthy lifestyle. It aims to prevent serious side-effects and reduce associated healthcare costs. Key features include: Lower co-pays (the portion of prescription costs paid for by the patient), making medicines more affordable and making it more likely that patients will adhere to their prescribed treatment regimen Regular meetings between patients and pharmacists to discuss symptoms and identify any potential complications as early as possible Help for participants to set and achieve nutrition, exercise and weight loss goals, including printed materials and meetings with pharmacist coaches We share the Challenge¶s findings and resources with other employers outside the ten cities through a dedicated website. The programme is based on the APhA Foundation¶s Asheville Project, which helped reduce healthcare costs for participating employees by over 34 per cent and cut absenteeism by 50 per cent on average. A pilot project based on the Asheville Project has now been launched in Japan. Run by a team from Showa University, the pilot will involve 100 diabetes and asthma patients over a two-year period.
Community health centres In 2008 we donated over $130,000 to the St Cecilia¶s health centre in New Orleans¶ Ninth Ward, a part of the city which saw great devastation during Hurricane Katrina. The money has been used to fund the clinic ¶s Community Diabetes Outreach Program, which has helped it to exceed the US national average for the percentage of diabetics receiving regular tests and controlling their symptoms. Read more about our efforts to raise awareness and prevent disease.
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Home Responsibility Contribution to global health Disease awareness and prevention
Corporate Responsibility Report 2008 Disease awareness and prevention We are one of the world¶s largest producers of vaccines which play a vital role in preventing disease. We also develop over-the-counter products which help people to stop smoking, lose weight and maintain good oral health. We help to raise awareness among healthcare professionals and the public through our work with patient groups and our own disease awareness campaigns. These can take place to coincide with the launch of a new product or after it is on the market. This can have a positive impact on public health and create commercial benefits for GSK. Read more about our efforts to raise awareness and prevent disease.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Contribution to global health Disease awareness and prevention Raising awareness about disease
Corporate Responsibility Report 2008 Raising awareness about disease In 2008, we ran a range of disease awareness campaigns including: Pandemic flu The World Health Organization considers that the world is now closer to another flu pandemic than at any time since the last outbreak in 1968. In 2008, we held a workshop for journalists at the European Influenza Congress in Portugal to highlight the threat of pandemic flu. Journalists play an important role in raising government awareness of health issues and influencing health policy. During the workshop, participants spent two hours talking to independent experts, discussing key subjects such as what we can learn from past pandemics, the personal and economic impacts of an outbreak, the role of vaccines and what governments should do to prepare. Read about GSK¶s flu products and our efforts to help prepare for pandemic flu. Cervical cancer Our vaccine Cervarix helps to prevent infection from the cancer-causing types of the Human Papillomavirus (HPV) which most commonly lead to cervical cancer. A year before we launched Cervarix in Europe, research in this region showed that as few as two per cent of women knew of the link between HPV and cervical cancer. Since then, we have run disease awareness campaigns across many countries to highlight this link and educate people on the importance of screening to help prevent cervical cancer. The campaigns target healthcare professionals, media, policy makers and women through press articles, educational events for healthcare professionals and support for cervical cancer patient groups and their activities, such as the European Cervical Cancer Prevention Week. Rotavirus Rotarix is our vaccine against rotavirus, a leading cause of gastroenteritis infection. Rotavirus is associated with 25 million clinic visits, two million hospitalisations and more than 600,000 deaths worldwide among children under five every year 1. The launch of Rotarix in Mexico in 2004 and other Latin American countries was preceded by a widespread disease awareness campaign. To achieve this, GSK educated journalists about gastroenteritis infection caused by rotavirus, its causes, how to prevent it and how to detect its symptoms early. Rotavirus can quickly become fatal if a child becomes dehydrated and does not receive treatment. Our educational materials discuss vaccination and give guidance on prompt detection and treatment methods. Chronic diseases in the US Our US Healthy Communities programme, which has offered free health screenings in communities across the country, aims to educate people about chronic diseases and encourage them to take better control of their health. People who do not manage their chronic diseases may develop further complications, leading to greater health problems. In 2008 we announced the findings of nationwide health screenings of 65,000 people conducted as part of the programme. Although approximately 70 per cent of participants reported their health to be excellent, tests indicated that many were not in good health. For example, nearly half of the participants with type 2 diabetes showed poor glucose control. Nearly a third of the asthmatics we screened had poor control of their
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condition. Of the individuals with poorly controlled diabetes or asthma, over two-thirds had not visited a primary care physician in the past year 2. GSK partnered with the National Association of Chronic Disease Directors (NACDD) and WebMD, the health information site, to help people become more engaged in managing their health. As part of our µtriple solution¶ approach we encourage people to assess their risk of chronic diseases using a health check tool that provides advice about the five biggest health risks. Dengue fever Paracetamol is the recommended effective symptomatic treatment for dengue fever, a debilitating disease that is transmitted by mosquitoes in tropical and sub-tropical regions. Few people know the correct treatment for dengue fever, especially for children. People often use other fever-reducers such as aspirin which can exacerbate bleeding, a symptom of dengue fever. They also seek medical treatment late, which increases the risk of serious complications and death. Panadol, GSK¶s over-the-counter paracetamol brand, has a strong presence in regions where dengue fever is prevalent, notably Asia, Africa, the Middle East and Central and South America. GSK is in a position to take the lead in driving global awareness among healthcare professionals and the public against the dengue fever threat. We initiated and sponsored a dengue fever public awareness campaign in high-risk areas including the Caribbean and South-East Asia. We have worked in collaboration with organisations such as UNICEF and the Pan America Health Organization. We also engage with locally respected campaign ambassadors. The campaigns increase awareness through television, radio and PR activities as well as roadside banners and posters in hospitals, public health centres, pharmacies and drugstores. Local media have picked up on these activities, helping to raise awareness further. Health professionals are targeted to raise awareness and provide information that can help in diagnosis and treatment. Free Panadol samples are distributed in hospitals. A campaign run in Costa Rica during 2006 contributed to a 68 per cent reduction in dengue fever cases as reported by the Board of Health. In 2007, when the campaign did not run, the number of cases increased by 110 per cent. In 2008, GSK activated the campaign again in collaboration with The Board of Health. By the end of 2008, the 'I save lives' campaign contributed to a 72 per cent reduction in dengue cases. Similarly the Panadol campaign contributed to decreases in South-East Asian dengue cases especially in Indonesia where the dengue fever fatality rate dropped by 40 per cent in 2008 over the previous year. GSK is planning to continue this campaign in 2009 and beyond. 1. Parashar UD, et al Global illness and deaths caused by rotavirus disease in children. Emerg Infect Dis 2003; 9:565-72 2. Data on file
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Home Responsibility Contribution to global health Disease awareness and prevention Preventing disease
Corporate Responsibility Report 2008 Preventing disease Vaccines Vaccines make a significant contribution to health and are recognised as one of the most successful ways of preventing disease. Vaccines are second only to clean drinking water in reducing the impact of infectious diseases. GSK is one of the largest suppliers of vaccines and is the leading supplier of childhood vaccines to UNICEF. Vaccines are designed to eradicate or control disease and on an individual level to prevent disease or limit its severity. They can be highly cost effective and benefit both society and individuals. Vaccines have widespread endorsement from supranational organisations, including the WHO and the United Nations. The World Bank proposes that governments should make immunisation a priority for their healthcare investment. Immunisation programmes successfully eradicated smallpox worldwide and have made significant progress towards the elimination of polio. Even when global eradication is not possible, diseases can be reduced to very low levels if vaccination is maintained at high levels. For example, where Haemophilus influenzae type b vaccines are used, bacterial meningitis caused by this virus has been dramatically reduced. The majority of cervical cancers are now preventable with vaccination against the Human Papillomavirus (HPV) combined with cervical screening. GSK¶s vaccine against HPV, Cervarix, is now available in more than 90 high-, middle- and low-income countries around the world and we are committed to working to accelerate global access to theYDFFLQHCervarix was chosen as the vaccine for the National Immunisation Programme (NIP) in the UK, the largest Human Papillomavirus immunisation programme in the world to date. Since the NIP launch in September 2008, over 70 per cent of girls aged 12 to 13 have been vaccinated.
Consumer healthcare products Smoking cessation Smoking is a major public health problem, contributing to around five million premature deaths worldwide every year. Nicotine replacement therapies (NRT) can significantly increase a smoker¶s chance of stopping. GSK created the first over-the-counter NRT and we now market a range of nicotine replacement brands, including NiQuitin CQ/NicoDerm, Commit lozenge and Nicorette. They have helped more than 6.5 million people stop smoking since 1996. We estimate that around 20 per cent of smokers currently have access to NRT. We aim to increase this figure to more than 80 per cent by 2013 by launching our nicotine replacement brands in new markets. Poverty can be a major barrier to NRT purchase, especially in emerging markets. We provide smoking cessation education and counselling support to the Brazilian government as part of its efforts to help lowincome smokers who are trying to stop smoking. In 2008, we supported a petition submitted by the New York Commissioner of Health, asking the US Food and Drug Administration (FDA) to allow over-the-counter NRT products to be sold wherever cigarettes are sold and permit the sale of smaller packs with fewer doses that would have much lower prices. The FDA does not currently allow the sale of smaller, or one-day, affordable pack sizes. In the UK, we support the National Health Service¶s Stop Smoking Clinics. We provide the clinics with educational materials and run online and telephone support for smokers. We also help train NHS nurses and pharmacists as µstop smoking¶ advisers.
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Preventing obesity Obesity is a major cause of ill health and disease such as diabetes. alli, our over-the-counter weight-loss treatment, helps people lose weight when combined with a low-fat, reduced calorie diet. alli has been marketed in the US since 2007. In 2008 it received a positive opinion as a non-prescription product from the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use. In January 2009, the European Commission granted a non-prescription licence for the product. Since its launch in the US, six million starter packs of alli have been sold, helping millions of people to lose weight. Read a case study on how we ensure that alli is marketed responsibly. Oral healthcare It is important that people maintain good oral health, to prevent gum disease and tooth decay. Our oral healthcare products include toothpastes, mouth washes and denture cleaners. Our facility in Weybridge, UK, which makes global brands Aquafresh and Sensodyne, is the largest oral healthcare research centre in Europe. Employees from the facility regularly visit oral healthcare conferences and publish articles in journals, to promote the importance of using oral healthcare products such as ours. We co-sponsor the Innovation in Oral Care Awards with the International Association for Dental Research and we run an award scheme that recognises innovative research into preventing mouth infections and improving oral healthcare diagnostics. Community investment We also invest in community activities that focus on disease prevention. For example, we participate in the Global Alliance to Eliminate Lymphatic Filariasis, a leading cause of disability in tropical countries. Our PHASE hand-washing programme helps to prevent the spread of diarrhoea-related disease in children in developing countries. Back to top
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Home Responsibility Contribution to global health Investing in R&D
Corporate Responsibility Report 2008 Investing in R&D Despite advances in healthcare there are still many diseases for which there is no cure or for which treatments could be improved. Continued research and innovation is essential. Our investment in R&D into new medicines and vaccines is at the core of our business. In 2008, we spent 3.7 billion on R&D. Over 80 per cent of this expenditure was in pharmaceutical R&D with the remainder in vaccine and consumer healthcare R&D. We have nearly 150 prescription medicines and vaccines in clinical development, detailed in R&D of our Annual report. Our current late-stage pipeline includes products targeting diseases including many forms of cancer, infections, respiratory diseases, autoimmune disorders, metabolic and cardiovascular disease, psychiatric disorders and neurological diseases. In 2008, nine new products were approved for the first time. We made six first submissions for new products and product line extensions. For example, reflecting our strong focus on oncology, in December 2008 we filed in the US for a licence for pazopanib for the treatment of advanced renal cell carcinoma. Read about how we ensure high ethical standards in our R&D activity.
Expanding research capabilities and improving productivity One of our strategic priorities is to improve R&D productivity. During 2008 the R&D organisation was restructured to support this. The changes are described in the R&D section of our Annual report. In early 2008 we conducted a review, involving external experts, to identify the therapy areas where recent advances in science mean that there is more probability of finding new treatments. Based on the outcomes of the review, we refocused our early-stage research activities on the following areas: Biopharmaceuticals Immuno-inflammatory diseases Infectious diseases Metabolic pathways Neurosciences Oncology Ophthalmology Respiratory diseases R&D in China
Our Chinese R&D centre, opened in 2007, now has over 200 employees and in 2008 moved to state-ofthe-art facilities in Shanghai. The centre is investigating neurodegenerative disorders such as Alzheimer¶s disease, Parkinson¶s disease and multiple sclerosis. The centre is already progressing an early pipeline from target validation to candidate selection. We intend to develop the centre into our lead facility for global discovery and development activities in neurodegenerative disorders. The costs of conducting research in China can be lower than in other markets. However, lower costs are
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not the primary reason for opening the facility. China offers a huge pool of scientific talent ± our 2008 recruitment roadshow reached over 1,200 PhD graduates at ten top universities. Our R&D in China is conducted to GSK¶s global quality and ethical standards. All our R&D policies and monitoring procedures are global and apply to our operations in China.
Investing in new areas of science We are investing in technologies which are providing new opportunities for medical intervention, including: Stem cell technology We believe that stem cell science has great potential to aid the discovery of new medicines by improving screening, identification and development of new compounds. Using stem cells could also help us to develop medicines that are safer and more effective. Read about our collaboration with the Harvard Stem Cell Institute and our participation in the Stem Cells for Safer Medicines, a public-private partnership. External collaborations GSK does not have a monopoly on the best science and we are expanding our collaborations with external partners and business development activities to access innovations from outside our own organisation. We now have 35 external collaborations underway to complement our 35 internal Discovery Performance Units. Our immuno-inflammation Centre of Excellence for Drug Discovery announced a five-year research partnership with the Immune Disease Institute (IDI) in Boston, US. The partnership will combine IDI¶s worldclass immunological expertise with GSK¶s pharmaceutical capabilities. In 2008 we also signed our first agreement with the University of Cambridge to develop a compound with the potential for treating obesity and addictive disorders. The University will contribute know-how and expertise and will bear some of the financial risk for which they will be compensated if the programme is successful. GSK will provide operational support, access to our in-house clinical research and imaging facilities, and background preclinical data on the drug. Cambridge University will dedicate a team of academic experts in both neuroscience and metabolic disorders. Importantly, the agreement allows the academic scientists the freedom to publish the results from their work on µincubator¶ projects. In 2008 we acquired the pharmaceutical company Sirtris, which is the leader in research into sirtuins, a recently discovered class of enzymes believed to be involved in the ageing process. The combination of the specialist knowledge within Sirtris and GSK¶s development capabilities will provide the best possible chance of validating this new approach to diseases of metabolism and ageing. Read more about our investment in new technology in our Annual report. Back to top
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Home Responsibility Contribution to global health Contributing to scientific understanding
Corporate Responsibility Report 2008 Contributing to scientific understanding We fund basic medical research conducted outside GSK to increase understanding of the human body and the impact of disease. This is often the foundation for future advances in the diagnosis, treatment and prevention of disease. Often this research is conducted in partnership with others, using very new technologies. Examples from 2008 include:
Open innovation In December 2008, we announced a joint 4.1 million investment with the Wellcome Trust to generate µchemical probes¶ for 25 proteins involved in epigenetic signalling and to make them available to other researchers, without restriction. The partnership is part of our new commitment to promote openness in research collaborations. GSK and other pharmaceutical companies have traditionally kept research data confidential. This public-private partnership will be led by the Structural Genomics Consortium, and involve the National Institutes of Health¶s Chemical Genomics Centre in Washington, US, and the University of Oxford. The initiative could offer a new model for future interactions between academia and industry.
Collaborating to accelerate drug development In 2008 we renewed our support for the University of Dundee¶s Division of Signal Transduction Therapy (DSTT), in collaboration with the Medical Research Council and a consortium of other pharmaceutical companies. The aim of the DSTT is to accelerate the development of drugs that treat diseases such as cancer, diabetes and rheumatoid arthritis by targeting kinase and phosphatase enzymes. The collaboration will provide 10.8 million to the DSTT between 2008 and 2012. GSK has been working with the PATH Malaria Vaccine Initiative (MVI) since 2001 to develop the paediatric vaccine against malaria, RTS,S/AS. In December 2008 the partnership announced study results which showed that RTS,S/AS provides both infants and young children with significant protection against malaria. Pending national regulatory approvals, phase lll studies will start in seven countries across Africa in early 2009.
Patient safety A GSK team won a 2008 Wall Street Journal µTechnology Innovation Award¶ for Healthcare IT. The team developed a new software system that helps to screen novel drug candidates for potential safety issues. The system, known as Molecular Clinical Safety Intelligence (MCSI), helps GSK researchers to screen and prioritise novel drug candidates for potential adverse medical reactions at a much earlier stage, prior to clinical trials. The software enables direct translation of safety knowledge from human clinical experience to early-stage drug discovery for the first time. Read more about patient safety at GSK. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Contribution to global health Contributing to scientific understanding Academic collaborations
Corporate Responsibility Report 2008 Academic collaborations We invest in research capabilities at universities, fund leading-edge academic research projects and support science students. We have more academic collaborations than any other UK-based company, providing support of more than 24 million in 2008. Our support benefits academic institutions through increased funding, technology transfer and access to our research facilities and expertise. It contributes to better scientific understanding and capability in the countries where we operate. It benefits GSK by enabling us to tap into R&D expertise and activity outside the company and expands our potential recruitment pool of better trained scientists. Our support in 2008 included: The Academic Discovery Performance Unit, a new initiative to combine the best academic thinking with GSK¶s industry expertise A new agreement with the University of Cambridge to develop a novel agent with therapeutic potential for treating obesity and addictive disorders Alliances with leading universities to help accelerate drug discovery. For example, we have established research agreements with Trinity College Dublin and the University of Manchester A collaboration with agencies including the UK Engineering and Physical Sciences Research Council (EPSRC) and the Wellcome Trust to fund projects of mutual interest Training in GSK laboratories for undergraduates The intellectual property rights relating to academic collaborations are typically held by GSK but our partner institutions are free to use the outcome of the collaboration for their own future research. The university also receives a percentage of any financial returns derived from the new intellectual property.
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Home Responsibility Contribution to global health Pandemic flu: responding to the H1N1 outbreak
Corporate Responsibility Report 2008 Pandemic flu: responding to the H1N1 outbreak Updated 24 August 2009. We have been preparing for an influenza pandemic flu for many years, researching and developing prepandemic and pandemic vaccines, antivirals and face masks, as well as our existing antibiotics portfolio. Our preparations meant we were able to respond rapidly when a new influenza A (H1N1) strain emerged in Mexico in late April 2009. The World Health Organization¶s (WHO) decision on 11 June 2009 to move to Pandemic Alert Level 6 sent a particularly strong message to governments and other stakeholders involved in pandemic preparedness to ensure that adequate and robust plans are in place to respond to the new strain of H1N1 (known as ¶swine flu¶). A collaborative global response involving governments, international organisations and businesses is needed to reduce the impact of H1N1. GSK is committed to supporting governments and health authorities around the world to respond to this challenge.
GSK¶s contribution We offer three key products to combat pandemic flu: an H1N1 pandemic vaccine, Actiprotect a face mask and Relenza, an antiviral,. We have invested over US$2 billion to expand our capacity to manufacture these products. We believe that the global community should take steps to protect all populations, including those without resources to protect themselves. Read about our efforts to help facilitate access to Relenza and our pandemic flu vaccine in developing countries. Prevention and treatment ± our products Prevention Vaccines Immediately after we received the H1N1 ¶swine flu¶ virus strain in late May 2009 we began production of a vaccine that will help protect people against H1N1. We were unable to begin production before this because a vaccine needs to be based on the strain that it is acting against. We are now in full scale production at our manufacturing facilities in Canada and Germany and are working to make the vaccine available as quickly as possible. We expect to produce several hundred million doses of the H1N1 vaccine, to be delivered from September 2009 onwards. To date, GSK has received orders for 326 million doses. The vaccine is made up of an antigen (which stimulates an immune response to the virus) and an adjuvant (which helps to boost the immune response). The use of an adjuvant should help to increase the effectiveness of the vaccine and it should also mean that less antigen will be needed to produce the same amount of vaccine 1,QDGGLWLRQLQFOLQLFDOVWXGLHVZLWKWKH+1 (avian) influenza strain, the adjuvanted vaccine demonstrated the potential to provide protection even if the influenza strain drifts (changes slightly). 2,3 Delivery of the vaccine depends on gaining approval from the regulator. We are in discussion with authorities around the world to ensure the regulatory process proceeds asTXLFNO\DVSRVVLEOH,Q*6. received a European licence for a pandemic vaccine, based on a µmock-up¶ dossier containing data on H5N1 avian flu. We anticipate that this provisional licence will speed up registration of the H1N1 vaccine, because we can quickly supplement the data in the dossier with data on the actual H1N1 pandemic strain.
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We are currently in discussions with regulatory authorities to develop appropriate clinical development plans IRUWKHYDFFLQH The number of people studied in initial trials will be limited, because we need to provide governments with the vaccine as quickly as possible. Additional studies and ongoing monitoring will therefore be conducted once the vaccine is launched. GSK will rapidly share results of immunogenicity and postmarketing safety and effectiveness studies with the international community. Face masks GSK has developed Actiprotect, a face mask coated with an antiviral agent that provides a physical barrier that prevents the wearer from inhaling virus particles and kills the flu virus within one minute of contact. ActiprotectKDVQRWEHHQWHVWHGDJDLQVWWKHSDQGHPLF +1 VWUDLQ+RZHYHUWKHPDVNKDVEHHQ shown to inactivate all influenza virus strains that it was tested against including previous strains of H1N1, H5N1, H5N9, H2N2, H3N2, and an influenza B strain. We currently have limited manufacturing capacity for Actiprotect:HKDYHWKHUHIRUHLQYHVWHGLQLQFUHDVLQJ existing manufacturing capacity and are also seeking additional manufacturing capability through discussion ZLWKRWKHUFRPSDQLHV Treatment Relenza (zanamivir) is an antiviral that shortens the duration of flu, helping sufferers to feel better sooner. GSK has been working with governments to supply Relenza for use in a pandemic since 2003, when the global spread of avian flu (H5N1) began. Clinical tests show that H1N1 is also sensitive to Relenza. Following the outbreak of the H1N1 strain, we contacted governments around the world to establish demand for Relenza, to ensure equitable distribution of existing supplies and to put in place a series of measures to raise production levels. As a result, we now expect to increase our annual production capacity of Relenza to 190 million treatmentFRXUVHVE\WKHHQGRI 7KLVLVD more than threefold increase on our previous maximum annual capacity of 60 million treatment courses. Relenza is registered in over 100 countries and we currently have contracts in place to supply it to more than 60 governments. Supporting access to our pandemic flu products Many developing country governments lack the resources to protect their populations against H1N1, and they are concerned about their ability to mount an effective, rapid response. GSK is committed to facilitating access to Relenza and our pandemic flu vaccine in all countries. We strongly endorse the principles set out by the Gates Foundation to help guide global allocation of pandemic vaccines, and we support its message that the global community should take all steps necessary to protect all populations, including those without resources to protect themselves. We have committed to donate 50 million doses of our H1N1 vaccine and 2 million treatment courses of Relenza to the WHO for use in developing countries. To further ensure the vaccine is available to developing countries, and subject to the yield and existing contractual commitments, we have also allocated 20 per cent of H1N1 vaccine production capacity at our Canadian manufacturing site to developing countries. Ten per cent of our new, increased Relenza production capacity has also been allocated for developing countries. These commitments include the two donations to the WHO. We operate a tiered-pricing policy for both our pandemic vaccine and Relenza, based on World Bank classification of countries and GAVI eligibility for the vaccine. In line with our commitments set out in March to make our branded medicines more affordable to the world's poorest people Relenza will continue to be available at not-for-profit prices to Least Developed Countries. We remain committed to engaging in voluntary licence discussions with any companies willing to manufacture and supply zanamivir-containing products, the active ingredient in Relenza, for use in developing countries. For example, in 2006 we granted a voluntary licence to the Chinese manufacturer, Simcere, to manufacture and sell products containing zanamivir in China and a number of other countries, including all 50 of the world's Least Developed Countries.
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Ensuring business continuity We have taken steps to ensure that during a flu pandemic we can continue to supply essential pharmaceuticals and vaccines (against influenza and other serious diseases) to patients that need them. Read more about our business continuity plans. 1. Leroux-Roels et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370 (9587): 580±89. 2. Leroux-Roels I et al, Broad Clade 2 Cross-Reactive Immunity Induced by an Adjuvant systemed Clade 1 rH5N1 Pandemic Influenza Vaccine PLoS ONE 3(2): e 1665. doi:10.1371/jounal.pone.0001665 3. Baras et al. Cross-protection against lethal H5N1 challenge in ferrets with an adjuvanted pandemic influenza vaccine. PLoS ONE 2008; 3 (1): e1401. Back to top
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Home Responsibility Contribution to global health Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders Is your goal to cure disease or to find treatments for ongoing, chronic use? Ideally we want to cure disease. Our antibiotics help to treat diseases caused by bacterial infection and our anti-parasitic medicines help prevent and treat prevalent diseases such as lymphatic filariasis and malaria. Unfortunately, there is no known cure for most diseases. Our medicines help reduce symptoms and may need to be taken for long periods. These medicines are still valuable because they may enable the patient to have a more normal lifestyle, for example remaining in work or looking after their family. In many cases we are continuing research to find a cure. Ideally we want to prevent a disease from occurring in the first place, which is where vaccines have an important role. What factors do you consider when prioritising your R&D efforts? There are three main interrelated factors ± science, patient need and commercial potential. We assess scientific opportunities to determine how advances in scientific and disease understanding may lead to innovative new ways to treat or prevent disease. In 2008, we used the outcome of a systematic Therapy Area Review looking at the scientific understanding in 17 therapy areas to refocus our research effort. We continually evaluate the scientific information we obtain on our compounds to help us predict whether they can be developed into effective and well-tolerated medicines. Assessing patient need is fundamental to R&D at GSK. This ranges from looking for medicines that will treat diseases for which there are no current effective treatments, to the development of medicines that improve on existing treatments in terms of safety, efficacy or ease of use. Our assessment of the commercial potential of possible new treatments includes: how our product would be differentiated from those of our competitors; the size of the potential market for any new treatment; and the range of conditions it may be suitable for treating. The better able we are to meet patient needs, the more likely it is that a product will be commercially successful. However, it is not always possible to achieve a return on investment, for example when developing treatments for diseases that are prevalent in the developing world. In some cases, where commercial potential is limited but patient need is high, we may seek ways to share the costs and risks associated with drug development. Are you researching drugs to treat serious diseases? Our pipeline and product range includes products against most of the major causes of mortality and morbidity (disease). Our product launches in 2008 included Promacta for treatment of idiopathic thrombocytopenic purpura and Volibris for pulmonary arterial hypertension. Our top-selling products in 2008 treat asthma and chronic obstructive pulmonary disease, epilepsy and bipolar disorder, diabetes, herpes and migraine. Our vaccines portfolio includes vaccines to prevent influenza, hepatitis, rotavirus and Human Papillomavirus infection which can cause cervical cancer. We also make vaccines to prevent many childhood illnesses such as measles and rubella. How do you measure R&D productivity? The ultimate measure of our productivity is the delivery of new medicines to meet patients¶ needs. In 2008,
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GSK launched three products based on new chemical or biological entities, six new vaccines and a number of product line extensions that benefit patients. Our target is to sustain a late-stage pipeline of around 30 key assets. However, given that research and development can take longer than ten years, we measure productivity in a number of ways during the R&D process, including: The number of compounds in our pipeline, and the emerging risks and benefits of these compounds Our success at progressing compounds in our pipeline through clinical trial phases l, ll and lll and to market registration The speed of progress through our pipeline, which is an indication of the efficiency of our R&D processes Is it true that research productivity is falling in large pharmaceutical companies? How is GSK managing this? Investment in pharmaceutical R&D has risen while the number of new medicines gaining regulatory approval has remained relatively constant or decreased. We believe there are many reasons for this, including: An increasing focus on R&D into chronic degenerative diseases such as Alzheimer¶s which are scientifically challenging, require longer clinical trials and have increased failure rates Significant investment by industry in new technologies which will help deliver innovative medicines in the longer term, for example systems biology tools, genome-wide association scans, new in vitro and in vivo models and sophisticated imaging equipment More extensive requirements from regulators and healthcare payers, including the need to conduct larger clinical studies to evaluate the long-term outcome of treatment with a medicine, as well as higher hurdles for approval The effectiveness of existing treatments for some conditions, so that demonstrating improved safety or efficacy of a new treatment is increasingly difficult Our approach is to focus on meeting patients¶ needs and increasing the effectiveness and efficiency of R&D. For example, in 2008 we established 35 Discovery Performance Units (DPU) within our established Centres of Excellence for Drug Discovery. DPUs are small groups of scientists focused on a specific disease or molecular pathway, and structured to be as efficient as possible. These organisations combine the entrepreneurial approach of a small company with the resources and reach of a larger organisation. Back to top
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Home Responsibility Access to medicines
Corporate Responsibility Report 2008 Access to medicines Access to healthcare is one of the world¶s most pressing social challenges. Every year millions of people in developing countries die from curable infectious diseases because they do not have access to basic healthcare services, including essential medicines. Millions more are unnecessarily exposed to the threat of ill health through inadequate or ineffective disease prevention strategies. There are a number of complex factors that prevent access to medicines. There is often a limited prospect of a commercial return on R&D for neglected diseases; there is no unified registration system for medicines which makes the registration process costly, complex and time consuming; in many developing countries there is no distribution network for medicines and no healthcare infrastructure to treat patients and prescribe medicines. However, these problems must not be an excuse for inaction; rather they should indicate where action is most needed. Over the last decade, the pharmaceutical industry has helped to address healthcare challenges in the developing world by researching new medicines and making them more available and affordable. Despite this progress, the scale of the healthcare crisis means that the industry must now take a more proactive approach. We have identified four key areas through which we will strengthen our approach: 1. Being more flexible on intellectual property 2. Being more flexible on pricing 3. Recognising that we achieve more in partnerships than we do alone 4. Looking at how we can move from being a supplier of medicines to being a partner in delivering solutions Read more about our plans in these areas. Abbas Hussain, President of Emerging Markets at GSK, leads our access efforts. These are also reviewed by the Corporate Executive Team, GSK¶s most senior team, and by the Corporate Responsibility Committee of the Board. Increasing access to medicines is important to our business for ethical, reputational and commercial reasons because: It is morally the right thing to do and is valued by our shareholders, employees and other stakeholders. It is aligned to our corporate mission and contributes to GSK¶s reputation and ability to attract and retain talented employees Our business objective is to increase the proportion of the world¶s population that has access to our medicines ± currently around 20 per cent. The successful pharmaceutical companies of the future will serve a bigger proportion of the world¶s population Our business relies on the intellectual property (IP) rights system which encourages medical innovation and progress. By taking measures to counter claims that IP is a major barrier to access, and by looking for ways to improve availability and affordability, we can help to increase access while maintaining support for intellectual property rights in our key business areas The access problem is not confined to the developing world. For example, in the US many people suffer unnecessary ill health because they do not have healthcare insurance.
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Our community investment programmes provide an additional resource for addressing healthcare challenges around the world. They support under-served communities through funding, education, practical support and donations. We are always looking to refine and improve our contribution to improving access to medicines and in 2009 our CEO Andrew Witty announced a number of new approaches that we will be pursuing. ³I believe the pharmaceutical industry has a huge role to play. But we need to take much more of a leadership role. Historically we have always reacted to problems. In the future I want us to be proactive, genuinely finding new ways to increase research, increase access and eradicate disease. ´ Andrew Witty, CEO (Speech at Carter Center, Atlanta, 4 December 2008) Highlights
Announced new approaches to increase flexibility in pricing in Least Developed Countries and intellectual property relating to neglected diseases Identified as the industry leader in the first Access to Medicines Index Successful results reported from phase ll clinical trials of RTS,S, our malaria vaccine candidate for African children Entered into new R&D partnership with the Drugs for Neglected Diseases initiative Not-for-profit prices for anti-retrovirals reduced Positive opinion received from the European Medicines Agency for our pneumococcal vaccine 349 million anti-retroviral tablets supplied to developing countries including 279 million tablets supplied by generic manufacturers licensed by GSK 1.1 billion vaccines shipped, of which almost 80 per cent went to the developing world. Restructured our commercial operations to reflect the needs of patients and business opportunities in emerging markets Entered into new partnerships and acquisitions to develop a more relevant product portfolio
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Home Responsibility Access to medicines Our approach and contribution
Corporate Responsibility Report 2008 Our approach and contribution GSK is committed to playing our full part in addressing healthcare challenges around the world. Our core business activity, developing and launching new medicines and vaccines, makes a significant contribution. We recognise that the scale of these challenges requires a coordinated approach and we are looking to expand research partnerships with governments, NGOs and other companies. While support for intellectual property rights is essential to encourage innovation, we want to find ways that we can use our intellectual property flexibly to speed up the development of medicines for neglected diseases, without compromising the sustainability of our business. There is only so much difference that our activities on R&D, pricing and working in partnerships can make while significant barriers to access remain in developing countries. Key among these barriers is the lack of healthcare infrastructure - both physical and human. Although we are not a health service provider, we want to work with others to deliver healthcare, which can include investing in infrastructure. We will seek new opportunities in this area and are already making a contribution in strengthening infrastructure. For example in 2008 we donated equipment for a state-of±the-art laboratory at the Lagos State University College of Medicine. Professor Clement Adebamowo, Chairman of the National Health Research Ethics Committee of Nigeria, said that the new laboratory would help Nigeria regain lost ground on health research and reclaim its position as a reputable partner in education and health research. Playing our part to address global healthcare challenges, both individually and through partnership, is not only the right thing to do, it also makes good business sense. We work to address global healthcare challenges through action in four areas: Improving affordability by preferential pricing of our medicines and tiered pricing of our vaccines in the world¶s poorest countries, exploring new business models in middle-income countries, and providing discount cards in developed countries Investing in research and development that targets diseases affecting the developing world Working in partnerships to research new medicines and to help deliver healthcare services Undertaking community investment activities and partnerships that foster effective healthcare We recognise that the developing world in particular poses many healthcare challenges. This requires a long-term commitment. Fundamental to our approach is the need to ensure that our contribution is sustainable and is built into the way we do business. We have a duty to try to ensure our products are used in a clinically appropriate way in all countries where they are available. This is particularly important in the case of communicable diseases, where inappropriate use of products can speed the development of resistance to treatment. Our activities are undertaken in partnership with organisations that have relevant specialist knowledge, such as governments, international agencies, charities, other private sector organisations and academic institutions. GSK was ranked top in the first Access to Medicines Index, published in June 2008. The Index rates companies on their performance according to eight criteria: management, influence, research and development, patenting, capacity, pricing, drug donations and philanthropy. While we retain some concerns with the methodology used in this report, we are pleased that our multi-faceted efforts to make our medicines
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more available have been recognised by the Index. This is testament to our innovative and sustainable approach, and the many GSK employees who contribute to our efforts to help address healthcare challenges in the developing world.
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Home Responsibility Access to medicines The role of others
Corporate Responsibility Report 2008 The role of others Improving access to healthcare in developing countries is a complex challenge. We believe that only a holistic approach embracing prevention and treatment as well as fundamentally strengthening health systems will work. This will require all stakeholders, including the pharmaceutical industry, to work together to increase the resources dedicated to improving healthcare systems. Pharmaceutical companies, including GSK, must make their medicines as affordable as possible to people in the world¶s poorest countries, in a sustainable manner. We must invest in research into diseases of the developing world because new prevention tools and treatments are urgently needed. Companies must look for ways to use intellectual property rights flexibly to maximise R&D resources for neglected diseases. Rather than just being suppliers of medicines, we must also support governments in their efforts to strengthen health systems, developing innovative ways to deliver our medicines to the people who need them most. Wealthy nations must give more. New funding is coming from the Global Fund to Fight AIDS, TB and Malaria, the Bill & Melinda Gates Foundation, PEPFAR (The US President¶s Emergency Plan for Aids Relief), UNITAID and others, but funds are still inadequate and need to be more predictable and sustainable. Resources are needed to fund research, strengthen health systems, purchase medicines, support disease prevention and discourage the migration of trained healthcare workers from developing countries. The current global financial crisis must not divert resources away from assisting developing countries. Developing countries themselves must show genuine political commitment to prioritising healthcare in national budgets, addressing stigma and improving affordability by removing import tariffs on medicines. As part of this approach, middle-income countries must accept their responsibilities and not seek the lowest prices that are offered to the world¶s poorest countries. All countries should provide an environment that encourages innovation through support for intellectual property (IP) rights, and should avoid measures such as widespread compulsory licensing which may negatively impact on investment in R&D and innovation. A more supportive environment for IP generally will encourage companies to be more flexible with their IP and less defensive. Countries should also address the risk of product diversion from patients in poor countries to those in wealthier ones. We lobby governments and policy makers to advocate a sustainable approach to improving healthcare in the developing world. Such an approach must support innovation, which is critical to improving access in the longer term. In 2008 our work in this area included: Urging the G8 to continue making healthcare in the developing world a major agenda item Supporting the development of a pilot Advance Market Commitment for a pneumococcal vaccine Engaging in the work of the WHO¶s Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property Working with the UK government on global health issues and in the development of the Department for International Development¶s (DFID¶s) Medicines Transparency Alliance (MeTA) and the review of its Good Practice Framework for pharmaceutical companies Playing a leading role in Pharma Futures 3, an industry dialogue exploring the links between sustainable pharmaceutical business models and improved health outcomes in middle-income markets, including
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China, India and Brazil Discussing IP, innovation and funding with NGOs, foundations and other stakeholders Attending WHO Executive Board Meetings and the World Health Assembly Meeting with the UN Secretary General, Ban Ki Moon, to discuss priorities in addressing HIV/AIDS Contributing to the design of an Affordable Medicines Facility for Malaria Playing a leading role in major global health initiatives. For example GSK sits on the Boards of the GAVI Alliance and Roll Back Malaria Participating in Board meetings of the Global Fund to Fight AIDS, TB and Malaria and supporting the development of its Quality Assurance standards Contributing to development of UN Human Rights Guidelines for Pharmaceutical Companies in relation to access to medicines Engaging in the negotiations on the WTO Doha Round to seek sustainable pro-innovation outcomes Addressing HIV/AIDS in the EU and neighbouring countries through the European Commission¶s Bremen Process Engaging with the Intergovernmental Meeting on Pandemic Influenza Preparedness Contributed to a report being prepared by Paul Hunt, the UN Special Rapporteur on the Right to Health. The report is on GSK¶s approach to access to medicines. A number of senior executives, including our former CEO, Dr JP Garnier, and our Chairman Sir Christopher Gent, were interviewed. We expect the report to be published in the first half of 2009. Read more about our malaria advocacy.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Access to medicines Developing countries
Corporate Responsibility Report 2008 Developing countries Poverty is the underlying cause of the healthcare crisis in many parts of the developing world. In the world¶s poorest countries, millions of people do not have reliable access to food and clean water, never mind adequate healthcare services. The healthcare crisis in the developing world is complex, and only a holistic approach will work to improve the situation. This must involve a comprehensive programme of prevention, health education, screening diagnosis and treatment, community care and support. Increasing access to medicines also plays a vital part. In all of these areas, GSK seeks opportunities to make a contribution. Significant additional funding from national and international sources must be mobilised to really make a difference. The WHO recommends a minimum spend on health of 17 per person per year to provide the most basic health services. Yet the average spend in sub-Saharan Africa is just 5, according to the UK¶s Department for International Development. The African Region of the WHO suffers more than 24 per cent of the global burden of disease, but has only three per cent of the world¶s health workers. The pharmaceutical industry must look to form partnerships to help deliver healthcare services. Political will is needed to aid development and build healthcare infrastructure. GSK can make an important contribution by: Researching new treatments and vaccines for diseases affecting developing countries Registering our products in the countries where they are needed most Offering preferential pricing arrangements for medicines and tiered pricing for vaccines that are needed most Seeking innovative partnerships to help improve healthcare in the developing world Granting voluntary licences to allow companies to manufacture our medicines Investing in projects to support healthcare delivery in under-served communities Diseases disproportionately affecting developing countries
Malaria kills over a million people a year, mostly children under five years old Around two billion people worldwide are infected with TB and over 1.5 million people die from the disease each year. No new treatments for TB have been developed in the last 40 years UNAIDS estimates that HIV/AIDS-related illnesses killed two million people in 2007 and that over 33 million people worldwide are living with HIV Worldwide a woman dies of cervical cancer every two minutes; 85 per cent of these are in the developing world Rotavirus infection causes 600,000 deaths each year, mostly in children under two years of age. Up to 85 per cent of these deaths occur in low-income countries
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Home Responsibility Access to medicine Developing countries Research and development
Corporate Responsibility Report 2008 Research and development For some diseases affecting developing countries there are no effective treatments. In other cases, treatments exist but have become less effective due to drug resistance. Sometimes treatments are not suitable, for example, because they are difficult to administer in areas with poor healthcare infrastructure or they are too expensive. As a research-based company, we aim to make a major contribution to health in developing countries by researching and developing affordable new vaccines and treatments for infectious diseases. We are currently conducting R&D into 12 diseases of particular relevance to the developing world: bacterial meningitis, chlamydia, dengue fever, hepatitis E, HIV/AIDS, leishmaniasis, malaria, pandemic flu, pneumococcal disease, Chagas disease, human African trypanosomiasis and TB. For more information on our R&D pipeline see our Annual Report. Biomedical R&D is a costly, risky and time consuming activity. To develop one successful medicine or vaccine it can typically take 10 to 12 years and, on average, including the costs of failures, costs around $1.2 billion 1. For every 5,000 to 10,000 compounds tested, an estimated five reach clinical trials and only one reaches the market 2. What¶s different about R&D for medicines for the developing world?
GSK scientists working on treatment projects for diseases of the developing world (DDW) make access to medicines a priority right from the start of the R&D process. When researching a new DDW treatment we emphasise factors such as: Heat and humidity resistance ± the product must be able to survive in a hot climate where there may not be refrigeration facilities Ease of use ± it must be easy to use in settings where there are limited healthcare facilities. For example, once-a-day tablets that can be taken at home are preferable to an injectable medicine that must be administered in a hospital or clinic Affordability ± price is one of the most important factors. We look for molecules and formulations that are straightforward to manufacture and therefore inexpensive to produce For diseases which disproportionately affect the developing world, but where a market exists in developed countries such as HIV/AIDS, we can still pursue this business model. We will accept all the R&D costs and risks involved on the expectation that there will be a market in wealthy countries that can subsidise poorer ones. For other diseases of the developing world where no such market exists we have to pursue new ways of working. One solution is the public-private partnership (PPP) model, in which businesses and the public sector work together. The model enables collaborators to achieve more together than they would do alone. We are also exploring ways to share knowledge with other organisations to help facilitate and speed up the discovery and development of new medicines. By being more flexible with our intellectual property, we aim to encourage other pharmaceutical companies to follow suit. We believe GSK is currently the only company researching new vaccines and treatments for all three of the WHO¶s priority infectious diseases, malaria, TB and HIV/AIDS. We also have an extensive portfolio of R&D projects for diseases of the developing world. We are an industry leader in research into HIV/AIDS treatment, and are currently evaluating multiple second-generation integrase inhibitors in clinical development.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
We also look for new treatments for other neglected diseases, typically in collaboration with external partners. For example, we engage in ongoing R&D programmes in leishmaniasis, Chagas disease and human African trypanosomiasis (African sleeping sickness). We have created a dedicated group to focus on diseases of the developing world which is fully integrated into our pharmaceutical R&D organisation. This group prioritises projects based on their socio -economic and public health benefit rather than on commercial returns. In addition to scientists based in the UK and US, this includes a drug discovery centre at our Tres Cantos R&D site in Spain where over 100 scientists focus primarily on malaria and TB. Half of these scientists are funded by PPPs, the Medicines for Malaria Venture and TB Alliance. A group focused on developing world diseases is also active in our vaccines organisation in Belgium. We are looking at ways to expand the Tres Cantos site into a global centre of excellence by encouraging investment and collaboration from governments, NGOs and other companies. Our overriding objective is to ensure that GSK makes the best possible contribution to improving the health of those affected by neglected diseases of the developing world. This will be achieved by pursuing an approach that will lead to the most extensive, effective and sustainable pipeline for diseases of the developing world (DDW) by: Increasing partnerships with external DDW communities to cover more neglected diseases, more diverse expertise, research tools, novel targets, developable drug candidates and worldwide talent pool including strong links with the best academic groups Spreading the DDW remits and learning in developing countries and emerging markets by sharing training activities and science forums for researchers or upcoming scientists from these countries, while avoiding any brain drain downsides Strengthening current R&D partnerships with organisations such as with Medicines for Malaria Venture (MMV), TB Alliance, Drugs for Neglected Diseases Initiative (DNDi), International AIDS Vaccine Initiative (IAVI), PATH, Malaria Vaccine Initiative (MVI) and the Aeras Global TB Vaccine Foundation, as well as seeking new partnerships Read our positions statements on: Clinical trials in the developing world Paediatric medicines Briefing: The treatment of children living with HIV in developing countries 1. Tufts Center for the Study of Drug Development 2. Pharmaceutical Industry Profile 2008, Washington DC, PhRMA March 2008
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Home Responsibility Access to medicine Developing countries Research and development Malaria
Corporate Responsibility Report 2008
Malaria We have been working on a malaria vaccine for over 20 years and have invested more than $300 million of our own resources to date. We are currently developing a candidate malaria vaccine, RTS,S, in partnership with the PATH Malaria Vaccine Initiative (MVI), which has contributed more than $100 million. In 2008, results of two separate phase ll trials confirmed the findings of earlier studies that the candidate vaccine provides infants and young children, the most vulnerable groups, with significant protection against malaria. In children aged five to 17 months, the RTS,S/AS01 vaccine reduced the risk of clinical episodes of malaria by 53 per cent over an eight-month period 1. In the other trial, among infants under 12 months who received three doses of a modified RTS,S/AS02 vaccine, the risk of first infection from malaria was reduced by 65 per cent over a six- month period 2. Trials also showed that the RTS,S/AS02 vaccine does not interfere with the efficacy of other vaccines administered through existing African national immunisation programmes. This means that in countries where malaria is most prevalent, the vaccine could be delivered through the current immunisation schedule for infants, called the WHO Expanded Program on Immunization (EPI). Christian Loucq, MVI Director, commented on the significance of the trial results by saying, ³we are closer than ever before to developing a malaria vaccine for children in Africa´. In 2009 we will commence large-scale phase lll vaccine efficacy trials in seven African countries across 11 sites. If these trials confirm the safety and efficacy of the candidate vaccine, it could be filed for registration in 2011 and introduced as early as 2012 for children five to 17 months of age. It will take longer to establish efficacy in infants of EPI age (six weeks old) due to the complexity of enrolment for trials, so the earliest the vaccine could be fully available following approval for use in infants is 2014. Read more in the malaria vaccine case study. Update August 2009
The Phase III trial of the RTS,S malaria vaccine candidate started in Bagamoyo, Tanzania, in May 2009. Our work on malaria treatments includes: Tafenoquine, a potential new treatment for the radical cure of P. vivax malaria being developed in partnership with the Medicines for Malaria Venture (MMV). As well as causing an acute infection of red blood cells, P. vivax causes a dormant infection of liver cells from which the parasites can reactivate, resulting in a reappearance of parasites in the blood and a recurrence of malaria. A radical cure implies the complete elimination of malaria parasites from the body, including the dormant liver stages. Tafenoquine offers the potential for a one to two day treatment course and could replace primaquine as the standard of care for a P. vivax radical cure. An initial study, commencing in 2009, will focus on further understanding the safety of tafenoquine in subjects with inherited glucose -6-phosphate dehydrogenase (G6PD) deficiency. ³Tafenoquine is a novel inclusion for MMV¶s portfolio. Given its activity against the liver stages of malaria, or hypnozoites, it is an essential part of the fight against P. vivax infections. As the malaria elimination agenda moves forwards we need an increasing array of tools against the parasite,´ said Dr Timothy Wells, Chief
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Scientific Officer at the Medicines for Malaria Venture. "MMV and GSK have worked successfully on a number of malaria projects in the past. Together, we hope to develop a radical cure for P. vivax malaria´. Pyridones, a new class of compounds with the potential to be highly effective against drug -sensitive and drug-resistant strains of both P. falciparum and P. vivax malaria. Pyridone GSK932121 is being developed in partnership with MMV. We entered µfirst time in human¶ clinical trials early in 2009. A back-up programme included in the GSK/MMV agreement is now well advanced and a candidate for development is expected by mid-2009 Isoquine, a new 4-aminoquinoline compound. The µfirst time in human¶ clinical trial was completed in 2008. Based on advice from the MMV Expert Scientific Advisory Committee and following discussions with all three partners (GSK, University of Liverpool and MMV), the isoquine project has been terminated until such time as evidence can be provided to demonstrate that adequate therapeutic blood exposures can be achieved after an acceptable oral dosage 1. Bejon P, Lusingu J, Olotu A, et al. Efficacy of RTS,S/AS01E : clinical malaria in 5 to 17 month old children. N Engl J Med 2008;359: 2. Abdulla S, Oberholzer R, Juma O, et al. Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med 2008;359:2533-44. 3. GSK press release issued 29 February 2008
Dacart and Lapdap
As reported in the 2007 corporate responsibility report, early in 2008 GSK and Medicines for Malaria Venture (MMV) received data from two phase lll clinical trials assessing use of the artemisinin-based combination therapy Dacart we were developing together. One trial was primarily designed to establish the efficacy of Dacart versus Coartem, currently the firstline anti-malarial therapy in many endemic countries. The second trial was designed to establish the efficacy of Dacart versus Lapdap (chlorproguanil and dapsone), another anti-malarial product GSK had developed in a partnership including the World Health Organization and the UK¶s Department for International Development3. A key safety finding from these trials was that patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency were found to be more at risk of anaemia after taking either Dacart or Lapdap. Consequently, given the haematological profile of Dacart, and the fact that 10-25 per cent of the population in subSaharan Africa is G6PD deficient, GSK and MMV decided to terminate the further development of Dacart. For the same reasons, GSK also decided to withdraw Lapdap from the market. This disappointment highlights the highly risky and complex nature of pharmaceutical research and development. However, GSK remains committed to working with partners such as MMV to seek solutions for patients suffering from this devastating disease.
Home Responsibility Access to medicine Developing countries Research and development Tuberculosis
Corporate Responsibility Report 2008
Tuberculosis Our tuberculosis medicines research is conducted in partnership with the Global Alliance for TB Drug Development (TB Alliance). In January 2008 we announced a renewal, for a further three years, of our joint research programme with the TB Alliance.
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Speaking at the time of the announcement, Dr Mel Spigelman, TB Alliance Director of Research and Development, said: ´We are encouraged by the success of our pioneering work with GSK, which has nearly doubled the number of TB drug discovery projects in our pipeline. This collaboration is advancing the TB Alliance¶s mission to develop revolutionary, faster and better TB treatment regimens by exploring new ways to attack the disease´. Our lead TB project on mycobacterium gyrase inhibitors expects to select a candidate for development by mid 2009. Other TB partnership projects under way include: Research into biomarkers. Currently, the effectiveness of a new TB drug cannot be determined until 18-24 months after completion of treatment. Biomarkers that enable us to predict at an early stage how patients are responding could significantly speed up TB research Mtb72f is our TB candidate vaccine being developed with the Aeras Global TB Vaccine Foundation. Early results are positive, suggesting that the vaccine is safe and produces a strong immune reaction in adults in TB endemic regions. Trials are now planned for infants in TB endemic regions.
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Home Responsibility Access to medicine Developing countries Research and development HIV/AIDS
Corporate Responsibility Report 2008 HIV/AIDS We have been involved in AIDS vaccine research for over two decades. GSK is also committed to the development of new molecules that target unmet medical needs in HIV, and there is a pressing need for a variety of new anti-HIV drugs with novel mechanisms of action.
Vaccines We are now pursuing three separate vaccine strategies. A successful AIDS vaccine might combine several of these approaches: Recombinant measles vector ± the measles vaccine is one of the most powerful, providing life-long protection against the disease. We are working with the Pasteur Institute in Paris to develop an AIDS vaccine by fusing genes from the HIV virus onto a measles vaccine F4co, our own candidate vaccine, will advance into phase l/ll trials in HIV-infected subjects in 2009 An extramural collaborative discovery R&D programme that aims to identify an HIV envelope-based protein vaccine capable of producing broadly neutralising antibodies against HIV infection In addition, we continue to collaborate with the International AIDS Vaccine Initiative (IAVI) and during 2009 we will be evaluating modifications to our joint programme.
Treatments GSK is committed to the development of new molecules that target unmet medical needs in HIV, and there is a pressing need for a variety of new anti-HIV drugs with novel mechanisms of action. Integrase inhibitors represent an important new class of compounds for the treatment of HIV, and it is increasingly clear that second-generation integrase inhibitors will be needed to address issues such as drug resistance and dosing complexity. We currently have a number of second-generation integrase inhibitors in the early stages of clinical development. In February 2009 we announced a licence agreement with Idenix Pharmaceuticals Inc. granting GSK exclusive worldwide rights to IDX899. This is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) in phase ll clinical development being developed by Idenix for the treatment of HIV/AIDS. New NNRTIs are needed to address the increasing prevalence of viral resistance and side effects associated with this drug class. To date, IDX899 has demonstrated high potency with low milligram doses, a high barrier to drug resistance, favourable risk/benefit profile and the convenience of once-a-day administration. In 2007, there were 2.5 million children living with HIV worldwide ± nearly 90 per cent of them in sub-Saharan Africa. We are committed to improving the treatment for children living with HIV/AIDS by developing products designed for use in children and developing scored tablets that simplify treatment. Scored tablets enable our anti-retrovirals (ARVs) to be broken into two smaller doses which simplifies treatment for children. WHO and UNICEF have stated that access to a tablet form of ARVs could improve treatment options for children able to swallow tablets. Tablets are often easier to store and distribute, and also less complicated to administer than the liquid formulations currently available ± particularly when two or three medicines are combined in one pill. In 2007 we gained approval from the European Commission for new scored tablets for Epivir, Combivir and Ziagen. This will enable children above 14 kilograms weight to benefit from a solid dosage form. In 2008 we received approvals for Epivir and Ziagen scored tablets from the US Food and Drug Administration and in
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February 2009 the FDA approved the scored version of Combivir. The new tablets can make treatment easier for children. For example, a child weighing 20 kilograms can now take half a tablet of Combivir in the morning and the second half in the evening in combination with another ARV, instead of requiring 8 ml of Epivir solution twice a day plus 12 ml of Retrovir solution three times daily. We have also committed to support four paediatric clinical studies in resource-poor countries to determine the best ways to expand access to HIV/AIDS treatment. Through our International HIV Collaborative Research Trials (CRT) Programme for resource-poor settings, we are supporting clinical trials that are sponsored by external organisations such as the WHO, the UK¶s Medical Research Council and the US National Institutes of Health (NIH). At the end of 2008, 20 trials were under way and a further three planned involving approximately 32,500 patients. Nineteen of the trials are conducted at sites in Africa. These CRTs focus predominantly on public health-related issues in the developing world, such as prevention of mother-to-child HIV transmission, paediatric treatments strategies and HIV-TB co-infection. GSK donates study anti-retrovirals and/or financial support, and also provides scientific input. Countries in which HIV CRT studies are being conducted include: African countries
Asia and Latin America countries
South Africa Uganda Zimbabwe Kenya Botswana Zambia Tanzania Malawi Ethiopia Mali Nigeria
India Thailand Cambodia Vietnam Brazil Haiti Peru Argentina
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Home Responsibility Access to medicine Developing countries Research and development Visceral leishmaniasis
Corporate Responsibility Report 2008 Visceral leishmaniasis (VL) Sitamaquine is our oral, once-a-day candidate treatment for visceral leishmaniasis (VL), a potentially fatal disease spread by parasites. Data from two phase ll proof-of-concept studies in Kenya and India are encouraging overall. After a 28-day course, 85 per cent of patients remained cured at six months 1 2 . Sitamaquine was generally well tolerated by patients in these studies. However, there were some concerns regarding renal adverse events seen in a few subjects, some of which appear to be treatment related. Interpretation of these data is complicated, in particular because VL itself is associated with renal impairment. Before proceeding to phase lll trials, we set up a phase llb study 3 to compare the safety and tolerability of a 21-day course of sitamaquine with that of intravenous amphotericin B. Early results showed comparable efficacy to previous studies, despite the shorter course, and sitamaquine was very much better tolerated than amphotericin. A small number of patients had mild, reversible renal side effects. We are currently reviewing the utility of sitamaquine as a potential treatment for VL with regulatory authorities and external stakeholders. 1. Wasunna M, Rashid JR, Mbui J et al. A Phase II dose-increasing study of sitamaquine for the treatment of visceral leishmaniasis in Kenya. Am J. Trop. Med. Hyg. 73(5):2005:871 -876 2. Jha TK, Sundar S, Thakur CP et al. A Phase II dose-ranging study of sitamaquine for the treatment of visceral leishmaniasis in India. Am J. Trop. Med. Hyg. 73(6):2005:1005-1011 3. Prasad LS, Sen S, Ganguly. Renal involvement in kala-azar. Indian J. Med Res 1992 Jan:95;43-46 - Dutra M, Martinelli R, de Carvalho EM et al. Renal involvement in visceral leishmaniasis. Am. J. Kidney Dis. 1985: (6); 22-27
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Home Responsibility Access to medicine Developing countries Research and development Pneumococcal disease
Corporate Responsibility Report 2008 Pneumococcal disease Pneumococcal disease is a global health issue. Each year, Streptococcus pneumoniae infections are estimated to kill one million children under five years of age worldwide. There are more than 90 distinct strains (serotypes) of pneumococcus but only 10-15 cause the vast majority of invasive disease in young children. In January 2009, the European Medicines Agency¶s Committee for Medicinal Products for Human Use issued a positive opinion and recommended approval of GSK¶s paediatric pneumococcal candidate vaccine Synflorix. The paediatric vaccine is proposed to be indicated for active immunisation against invasive pneumococcal disease and middle ear infections (acute otitis media) caused by S.pneumoniae in infants and children from six weeks up to two years. The European Marketing Authorisation for the vaccine is expected to be granted in the first half of 2009. We submitted a file for this potentially life-saving candidate vaccine to the World Health Organization for prequalification in early 2008. Prequalification is a service provided by the WHO to facilitate access to medicines in less affluent countries. We have also been in discussions with the Global Alliance for Vaccines and Immunization to accelerate the availability of funding for pneumococcal vaccination through the pilot Advance Market Commitment (AMC) mechanism. AMCs are a new approach to public health funding designed to stimulate the development and manufacture of vaccines for developing countries. Donors commit money to guarantee the price of vaccines once they have been developed, thus creating the potential for a viable future market.
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Home Responsibility Access to medicine Developing countries Research and development Neglected diseases
Corporate Responsibility Report 2008 Neglected diseases In March 2008, we announced a collaborative research effort with the not-for-profit organisation, Drugs for Neglected Diseases initiative (DNDi), targeting neglected tropical diseases which disproportionately affect the developing world. Research will focus on compounds that may have activity against the most neglected diseases, including visceral leishmaniasis (kala azar), human African trypanosomiasis (sleeping sickness) and Chagas disease. The collaboration, which has been established for an initial period of two years and may be extended, will focus on identifying and developing compounds from existing GSK programmes and will leverage the expertise of researchers from GSK at our Tres Cantos facility along with leading academic centres like the London School of Hygiene & Tropical Medicine. The collaboration has been formed to specifically address unmet patient needs as current treatments for these diseases have significant drawbacks, such as difficulty of administration, severe side effects, length of treatment, cost, and emerging parasitic resistance.
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Home Responsibility Access to medicine Developing countries Research and development Our plans
Corporate Responsibility Report 2008 Our plans In 2009 we plan to: conduct a large-scale phase lll malaria vaccine efficacy trial in seven African countries commence a study focusing on further understanding the safety of tafenoquine in subjects with inherited glucose-6-phosphate dehydrogenase (G6PD) deficiency select a candidate for our lead TB project on mycobacterium gyrase inhibitors development by mid-2009 initiate trails of our candidate TB vaccines in infants continue clinical development of multiple second-generation integrase inhibitors for HIV/AIDS enter µfirst time in human¶ clinical trials on pyridone932121, an anti-malarial being developed in partnership with MMV (this was achieved in January 2009), and select a back up candidate for development by mid2009 review the utility of sitamaquine as a potential treatment for VL with regulatory authorities and external stakeholders.
Pandemic flu If it happens, an influenza pandemic could have a devastating effect, particularly on the poorest countries that have the least resources and capacity to prepare. GSK is very active in global preparations related to pandemic flu. Read more about how we are helping countries prepare for pandemic flu.
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Home Responsibility Access to medicine Developing countries Public-private partnerships
Corporate Responsibility Report 2008 Public-private partnerships GSK must remain profitable to sustain our business and to provide funds to enable us to continue to develop new medicines and vaccines. There is often limited prospect of a commercial return on R&D into diseases of the developing world. Public-private partnership (PPPs) enable R&D into these diseases by making this work commercially viable by sharing the risks and costs involved. PPPs speed up the R&D process and enable all partners to do more than they could do on their own. In a PPP companies such as GSK provide the R&D, technology, manufacturing and distribution expertise. Academic institutions may also provide research and disease area knowledge. Public sector partners, governments and organisations such as the Bill & Melinda Gates Foundation help fund the development and delivery costs and ensure that medicines and vaccines get to the people who need them. Funds are usually channelled through organisations such as the Medicines for Malaria Venture (MMV) which also help to coordinate global R&D activity. PPPs can work in many different ways. For example, some of our partnerships are centred around our dedicated µdiseases of the developing world¶ discovery centre at Tres Cantos and our global vaccines business headquartered in Belgium. GSK provides the facilities for medicinal drug discovery and meets all the running costs. Of the 100 scientists at Tres Cantos, half are subsidised by our partner organisations, MMV and the Global Alliance for TB Drug Development. As compounds move into clinical development, GSK provides the clinical, regulatory and manufacturing expertise and resources through our global R&D and supply network. Partners help fund the cost of running clinical trials and address issues of access and distribution. This reduces the costs of development and gets new products to patients faster. Research programmes are overseen by joint steering committees with representatives from GSK and our partners. Under the terms of our agreements, all new treatments resulting from PPPs are made available to disease endemic countries at affordable prices. Accelerating Access Initiative
The Accelerating Access Initiative (AAI) is a public-private partnership to accelerate access to care and treatment for HIV/AIDS. GSK is a founder member of the AAI, formed in May 2000. The AAI is a partnership between UNAIDS, the WHO, the World Bank, UNICEF and UNFPA, and nine research-based pharmaceutical companies Abbott Laboratories, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, Merck and Co, Inc, Pfizer and Roche. The objectives of the AAI are to: accelerate sustained access and increase use of appropriate, good quality interventions for the prevention/treatment of HIV/AIDS ensure that care and treatment reach significantly greater numbers of people in need, through new alliances involving committed governments, private industry, the UN, development assistance agencies, non-governmental organisations and people living with HIV/AIDS A report from the Accelerating Access Initiative suggests that by December 2007, around 875,000 patients in developing countries were receiving at least one ARV treatment supplied by the nine R&Dbased pharmaceutical companies in the AAI. In the two years since December 2005, the total number of
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patients in developing countries receiving treatment from the AAI companies had increased by 22 per cent. In Africa alone, over 665,600 patients are being treated with at least one ARV supplied by the AAI companies, an increase of 49 per cent over two years. This has resulted in an over 70-fold increase in the number of people being treated with medicines supplied by the AAI companies in Africa since the establishment of the AAI in May 2000.
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Home Responsibility Access to medicine Developing countries Product registrations
Corporate Responsibility Report 2008 Product registrations Approach
Performance and plans
Rapid product registration is important to ensure new medicines reach patients as quickly as possible. But the regulatory process is complex, costly and time consuming. There is little regulatory harmonisation around the world and a distinct submission is required for virtually every country. Companies have to prioritise their regulatory resources. This has led to concerns that pharmaceutical companies are not doing enough to register essential medicines in developing countries, which prevents these countries from taking advantage of preferential pricing offers. We prioritise registration of our medicines based on commercial considerations, as well as prevalence of disease. We use mechanisms such as the European Medicines Agency (EMEA), Article 58, to help facilitate product registration in developing countries. Article 58 allows the Agency's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in cooperation with the World Health Organization, on medicinal products for human use that are intended exclusively for markets outside the EU, such as medicines to treat malaria or leishmaniasis. The positive opinion obtained via Article 58 can then be used to support the registration process in developing countries when conducting their own regulatory reviews. We regularly review the registration status of our key anti-retrovirals (ARVs) to prioritise registration based on the needs for ARVs. This helps to make Epivir, Retrovir, Combivir and Ziagen available as widely as necessary and possible. Screening and vaccination could prevent many thousands of women from getting cervical cancer. We are working to register our vaccine against Human Papillomavirus (HPV), Cervarix, as widely as possible so that women can be better protected from the disease. It is now available in more than 90 high-, middle- and lowincome countries around the world, and GSK is committed to doing what it can to accelerate global access to the vaccine. Read more about our position on cervical cancer prevention.
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Home Responsibility Access to medicine Developing countries Product registrations
Corporate Responsibility Report 2008 Product registrations Approach
Performance and plans
Cervical cancer and rotavirus In October 2007 we submitted Cervarix, our vaccine which helps to prevent infection with HPV, to the World Health Organization (WHO) for pre-qualification. Products with pre-qualification status may be used by UN agencies and the GAVI Alliance, as well as in mass vaccination programmes across the developing world. By submitting Cervarix for prequalification as early as possible, we are working to eliminate the historical 15 20 year delay for new vaccines to become available in developing countries. We anticipate pre -qualification in the first half of 2009. Early in 2007, we received pre-qualification status for our rotavirus vaccine, Rotarix, from the WHO. We concluded a deal with Brazilian government institute Fiocruz to supply enough Rotarix to protect every baby in Brazil against rotavirus for the next five years. This includes a technology transfer agreement under which Fiocruz will produce Rotarix for the domestic market and manufacture Rotarix for GSK under contract for export to other developing countries. This is similar to existing arrangements in Brazil for our oral polio vaccine, Haemophilus influenzae type b (Hib) vaccine and measles, mumps and rubella vaccine. The results of this approach with Rotarix in Brazil have been impressive.
HIV/AIDS GSK produces packs of ARVs specifically designed for and distributed in developing countries. These µaccess¶ packs of Combivir, Epivir tablets, Epivir solution and Trizivir are now registered in at least 33 countries. This means that these products are available for sale in over 50 of our target 64 countries, including those countries which do not have formal regulatory approval processes. Our second-line ARV, Ziagen, is formally registered in tablet form in 28 countries and as oral solution in 23 of our target 64 countries. Ziagen access packs are registered in some of these countries and we are in the process of seeking registration in the others.
Flu To support government preparations for a global flu pandemic, we have registered Relenza in more than 100 countries. Relenza is our anti-viral medicine which can help treat influenza.
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Home Responsibility Access to medicine Developing countries Preferential pricing
Corporate Responsibility Report 2008 Preferential pricing Approach
Performance and plans
Pricing is one factor that impacts on access to medicines and vaccines in developing countries. We price our medicines preferentially for developing countries and use a tiered pricing system in wealthier middleincome markets where people¶s ability to pay for medicines varies significantly. However, price is only one aspect of affordability. The other is ability to pay, which is down to provision and allocation of resources, primarily from governments, and poverty reduction. For the billion people who live on $1 a day, virtually nothing is affordable. Early in 2009 we announced a new strategic approach to pricing in the Least Developed Countries (LDCs) 1. From April 2009 we will reduce our prices for patented medicines in the LDCs so that they are no higher than 25 per cent of the price in the developed world. This will be the maximum price ± where possible we will go further and reduce our prices more aggressively, while ensuring we cover our manufacturing costs so this offer is sustainable. Price reductions in April 2009 will be for 110 products and formulations across Least Developed Countries, with an average price reduction of 45 per cent. We will also reinvest 20 per cent of our profits from LDCs back into projects partnering with organisations such as NGOs to widen access and strengthen the healthcare infrastructure of LDCs. Our sales in LDCs are relatively low so this 20 per cent of profit will be limited ± initially around 1 to 2 million a year. However, by our action we hope to send a signal to all multi-national companies operating in LDCs to join us and contribute to making a difference. In many developing countries the healthcare crisis is dominated by the social and economic impacts of HIV/AIDS, TB and malaria. GSK has both anti-retrovirals (ARVs) to treat HIV/AIDS and anti-malarial treatments in our portfolio. We are committed to increasing access by providing these medicines to the Least Developed Countries and sub-Saharan Africa at not-for-profit prices (see key facts box). We negotiate preferential prices for our HIV/AIDS medicines with middle-income countries on a case-by-case basis. Read more about extending our product portfolio in the developing world.
Vaccines ± our tiered pricing model Vaccines can make a significant contribution to public health , helping to prevent many potentially fatal infectious diseases. Immunisation is acknowledged by the World Health Organization (WHO) as being µamong the most cost-effective of health investments¶. We make our vaccine portfolio available at preferential prices to developing countries, using a tiered pricing system. Prices are linked to gross national incomes as defined by the World Bank as well as the size of an order and length of a particular supply contract. For the developing world, prices can be as little as a tenth of those for developed countries. We work with multinational organisations such as GAVI, UNICEF, the WHO and the Pan American Health Organization, governments and non-governmental organisations to provide appropriate and affordable vaccines for developing countries. We typically supply vaccines to GAVI and UNICEF at 10-20 per cent of developed world prices to these organisations. By selling our vaccines in large volumes through longer-term contracts we are able to significantly reduce the price of each individual dose. This includes basic polio vaccines as well as specially developed combination vaccines that target several diseases. In 2008, of the 1.1 billion vaccine doses we shipped, 78 per cent went
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to the developing world. Many of our vaccines are included in government vaccination programmes in middle-income countries. For example, Rotarix, our rotavirus vaccine, is now included in government vaccination programmes for newborn babies in Brazil, El Salvador, Mexico, Panama and Venezuela. In 2008 we supplied 20 million doses of this vaccine; the vast majority went to developing or middle-income countries. In addition to tiered pricing, we are looking for innovative ways to increase access to vaccines in poorer countries. One option being explored for Cervarix, our vaccine against Human Papillomavirus, is to partner with a major international non-governmental organisation. Through this partnership we will be able to use this organisation¶s distribution networks to increase the supply of our vaccine in developing countries, where most deaths from cervical cancer occur.
Preventing product diversion Product diversion, where not-for-profit medicines are illegally shipped back for sale in wealthier countries, denies treatment to patients in poorer countries. Our anti-diversion measures include specially designed access packs for most of our ARVs, and red rather than white tablets for Epivir and Combivir. We only enter into voluntary licences when we know the manufacturer can ensure product diversion will not occur. 1 As defined by the UN: http://www.un.org/special-rep/ohrlls/ldc/list.htm
Not-for-profit (nfp) prices for medicines ± key facts
GSK has offered preferential pricing for our anti-retrovirals since 1997 and formal not-for-profit (nfp) pricing since 2001. Our nfp prices are sustainable ± we do not make a profit on them, but we do cover our costs. This means that we can sustain supply of these high-quality products for as long as they are needed Not-for-profit prices apply to GSK¶s anti-retrovirals and malaria treatments Nfp prices are available to all the Least Developed Countries and sub-Saharan Africa ± a total of 64 countries In addition, PEPFAR projects and eligible Global Fund projects bring this number up to over 80 countries Eligible customers include public sector customers and nfp organisations as well as private employers in sub-Saharan Africa providing treatment to uninsured staff Combivir, our leading combination ARV, is available at $0.54 a day Our nfp prices include insurance and freight costs, unlike the prices quoted by most generic companies. They are applicable to orders of any size and are not dependent on large order quantities
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Home Responsibility Access to medicine Developing countries Preferential pricing
Corporate Responsibility Report 2008 Preferential pricing Approach
Performance and plans
We offer our anti-retrovirals (ARVs) and anti-malarials at not-for-profit (nfp) prices to public sector customers and not-for-profit organisations in 64 countries - all the Least Developed Countries and all of sub-Saharan Africa. In February 2008 we announced significant new price reductions for our ARVs offered on a nfp basis to these countries. This reduction was the fifth time we have reduced prices as part of our pioneering preferential pricing policy originally introduced in 1997. Combivir, our leading ARV, now sells at $197 per patient per year in the least developed countries compared to $730 in 2001. The most significant reduction, of almost 40 per cent, was on Ziagen oral solution (abacavir). This is recommended by the World Health Organization (WHO) for use in first-line and second-line regimens within resource-limited settings, particularly for children. A number of factors enabled us to implement these price changes, including improvements and efficiencies in manufacturing and supply, and reductions in the costs of active ingredients.
Number of tablets shipped In 2008, we shipped 11.4 million tablets of nfp Combivir and 58.6 million tablets of nfp Epivir to the developing world, compared with 13 million and 72 million respectively in 2007. The decline in supply of our own ARVs is more than outweighed by a growth in volumes from our licensees. In 2008 our licensees supplied over 279 million tablets of their versions of Epivir and Combivir to African countries. Supply of Combivir and Epivir tablets by GSK*
*This includes preferentially priced tablets supplied by GSK and tablets supplied by our licensees.
During 2008 GSK supplied ARVs at nfp prices to 37 countries, compared with 31 in 2007. We will continue to look for new customers for our nfp ARVs in these countries and regularly review our nfp prices. However, it may well be that our licensees are able to produce first-line ARVs at lower costs and will continue to increase their share of the business.
Patients receiving treatment
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It is difficult to estimate the number of patients treated as a result of our preferential pricing agreements, since we do not control healthcare provision. However, the WHO estimates that three million people in the developing world were treated with ARVs by the end of 2007, an increase of one million in a year. A report from the Accelerating Access Initiative (AAI) suggests that by December 2007, around 875,000 patients in developing countries were receiving at least one ARV treatment supplied by the nine R&D-based pharmaceutical companies in the AAI. In the two years since December 2005, the total number of patients in developing countries receiving treatment from the AAI companies had increased by 22 per cent. In Africa alone, over 665,600 patients are being treated with at least one ARV supplied by the AAI companies, an increase of 49 per cent over two years. This has resulted in an over 70-fold increase in the number of people being treated with medicines supplied by the AAI companies in Africa since the establishment of the AAI in May 2000. Read more about how a GSK vaccine has contributed to the elimination of Hib mengingitis.
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Home Responsibility Access to medicine Developing countries Pricing in middle-income countries
Corporate Responsibility Report 2008 Pricing in middle-income countries Approach
Performance & plans
Middle-income countries (MICs), such as Brazil, China, Thailand and Indonesia, and some low-income countries such as India are more economically developed than the world¶s poorest countries, and often have a large and affluent middle class. They therefore provide greater commercial opportunities than the world¶s poorest countries. According to a report by accounting firm, PricewaterhouseCoopers, the growing wealth of Brazil, China, India, Indonesia, Mexico, Russia and Turkey means they could account for 20 per cent of the global pharmaceutical market by 2020. However, many middle income countries also have large numbers of people living in extreme poverty and healthcare demands often outstrip available resources. These challenges are made worse by an increasing incidence of chronic diseases such as asthma and diabetes. To reflect this situation, in 2008 we restructured our commercial organisation. We split our old International division and created two new regions ± Emerging Markets and Asia Pacific. This will enable us to respond to commercial opportunities while reflecting the healthcare environment and individual needs. Increasing access to medicines in middle-income countries within a responsible commercial framework is complex. It is clear that there is no one universal µone size fits all¶ solution. This complexity was a key aspect in the Pharma Futures 3 dialogue, which explored the links between sustainable pharmaceutical business models and improved health outcomes in middle-income markets, including China, India and Brazil. It is vital that we identify the best approaches for GSK to address these complex challenges. The challenges include: Low government healthcare spend relative to gross domestic product (GDP). This can be as low as one per cent of GDP compared with an average of nine per cent in the EU Poor healthcare infrastructure, including hospitals, clinics, doctors and nurses A high level of income inequality within countries, which can complicate pricing considerations The affordability of medicines and vaccines Taxes and mark-ups on medicines and vaccines Stigma and discrimination associated with certain diseases Use of traditional medicines Remote rural populations We recognise that many middle-income countries need assistance. However, we believe a different approach is needed from the one we take in the world¶s poorest countries. Our offer to supply medicines at not-for-profit prices and vaccines at highly preferential prices in the world¶s poorest countries is only sustainable if we can continue to make an adequate return on them in wealthier markets. Many middle-income countries are also growing commercial markets for GSK and represent an
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important source of future business for our industry. Our response in these markets must therefore balance our commercial objectives with our global commitment: to work with governments and other stakeholders to support efforts to deliver our medicines and vaccines to as many needy people as possible. Our approach combines long-established practices such as voluntary licences, tiered pricing for vaccines and preferential pricing for HIV/AIDS and malaria medicines with more innovative strategies that focus on the different socio-economic groups within individual MICs.
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Home Responsibility Access to medicine Developing countries Pricing in middle-income countries
Corporate Responsibility Report 2008 Pricing in middle-income countries Approach
Performance & plans
Our approach to pricing in middle-income markets is constantly evolving and ongoing pricing pilot programmes are informing this evolution. These comprise a mixture of long-established practices and new approaches. We intend to formalise and communicate on our pricing policies in middle-income countries during 2009.
Long-established practices Tiered pricing for vaccines Our vaccines are available to 18 GAVI-eligible middle-income countries (MICs), including Indonesia, Sri Lanka and Cuba, at highly discounted prices. Many of our vaccines are also included in government vaccination programmes in middle-income countries. Preferential pricing for HIV/AIDS and malaria medicines We negotiate preferential pricing arrangements for HIV/AIDS medicines and anti-malarials with middleincome countries on a case-by-case basis. This is done bilaterally through dialogue with governments. We believe this approach is appropriate because the burden of disease and the resources available to address that burden vary significantly from country to country, and within countries. These arrangements combine a viable and sustainable commercial return for GSK with improved affordability for the healthcare systems concerned.
Novel approaches We are developing a more flexible, responsive approach to accessing private and public sector markets in MICs. Our strategy focuses on the different socio-economic groups within individual MICs. It uses the standard classifications for socio-economic groups, the A group being the wealthiest section of society and E being the poorest. Typically, a company such as GSK makes a disproportionate share of its sales to people in the A/B group with sales tailing off quite sharply in the C/D group. Usually we will be unable to compete with low-cost generic medicines for sales to the E group. We believe the most productive way for us to align our commercial and accessibility goals is to make our products more readily available to the C/D segment of the market. This will free up more government funding for the poorest segment of the population. We are exploring options through projects including: Tiered pricing models within as well as between countries, including those which enable products to be priced differently for the private and public health sectors Gauging the relationship between price and volume for selected products in targeted MICs. For example, we may be able to reduce the price of products where we have orders for a sufficiently high volume of products Local sourcing and manufacturing arrangements designed to address cost issues It is too early to draw definitive conclusions from these pilot projects and some results from the pilots are commercially sensitive. In the pilots investigating the relationship between price and volume, the volume
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targets were not achieved and the analysis was confounded by unexpected factors such as reduced demand for our diabetes medicine Avandia. However, it is clear that there are no simple or universal solutions. We have learned from the projects and will continue to investigate these approaches and establish further pilots where initial pilots have proved inconclusive. For example, we are exploring options such as within-country tiered pricing for vaccines. It is clear that pricing decisions cannot be assessed in a vacuum and other factors, such as market dynamics including new product introductions and how competitors react to our price changes, have to be taken in to account. It is also evident that not every programme will be suitable for every middle-income country. These pilots are therefore helping to inform our approach in middle-income countries. We are confident that the more successful elements will be incorporated into our long-term commercial strategy and we plan to report more on this during 2009. Cervarix price reduction ± Philippines, Vietnam, Indonesia and South Africa
GSK works in partnership with stakeholders to optimise the availability of its vaccine against human papillonnavirus. Improving access to treatment requires many stakeholders working together to develop better infrastructure, distribution channels, adequate funding, better disease awareness and education and the appropriate market dynamics. GSK is committed to ensuring pricing is not a barrier to access in the developing world and has reduced prices in the Philippines, Vietnam, Indonesia and South Africa. For example, in the Philippines we have reduced the price of Cervarix by 60 per cent. In South Africa, the price reduction is of the order of 40 per cent. GSK has a long track record of tiered pricing for vaccines available in government-led programmes, where we charge reduced prices in countries with lower levels of income. The reduction of the price for Cervarix in a number of countries is a further demonstration of our commitment to increasing access to our vaccines.
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Home Responsibility Access to medicine Developing countries Voluntary licensing
Corporate Responsibility Report 2008 Voluntary licensing Approach
Performance
Voluntary licences are granted by patent holders to allow a generics company to manufacture and sell their products. Some people assume that generics are always cheaper than branded products and are seen by many as a key solution to the access crisis in the developing world. Pharmaceutical companies are under increasing pressure to grant licences. However, generics are not always cheaper and the success of a voluntary licence will depend on the right licensees being chosen. This is particularly true for the treatment of a chronic disease like HIV/AIDS, where the sustainable supply of good-quality anti-retrovirals (ARVs) is key. We do not believe that voluntary licences are a universal solution to tackling HIV/AIDS or disease in general. In most cases local manufacture of ARVs will make little difference to their affordability and access to patients. This is a point endorsed by the WHO. This is because the real barriers to access are the lack of healthcare infrastructure and resources to pay for medicines regardless of where they come from. However, funding from the World Bank and other international donors has meant that voluntary licences can have a role to play in efforts to tackle the HIV/AIDS epidemic in sub-Saharan Africa by helping to increase the availability of medicines and contribute to better security of supply. A decision to grant a voluntary licence depends on a number of factors including, in the case of HIV/AIDS, the severity of the epidemic in that country, local healthcare provision and the economic and manufacturing environment. We discuss voluntary licences with potential partners on a case-by-case basis. We need to be sure that the manufacturer can provide a long-term supply of good-quality medicines and will implement safeguards to prevent the diversion of medicines to wealthier markets. We continue to consider the role of voluntary licensing in helping to increase access to medicines in middle income countries without undermining our commercial business.
Compulsory licences Compulsory licences are issued by governments and involve intellectual property rights being taken away from the rights holder. Compulsory licences are one of the flexibilities in the World Trade Organization ¶s TRIPS agreement on intellectual property which can be used for humanitarian purposes. However, widespread use of compulsory licences will undermine the intellectual property framework and be counterproductive in the long term. R&D into new treatments, especially where commercial markets exist such as for HIV/AIDS, depends on protection of intellectual property.
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Home Responsibility Access to medicine Developing countries Voluntary licensing
Corporate Responsibility Report 2008 Voluntary licensing Approach
Performance
We granted our first voluntary licence (VL) in 2001 and have now negotiated eight licensing agreements for our ARVs in Africa. Some of our VLs cover individual countries or trade blocs while others cover all of sub Saharan Africa. Update August 2009
In July 2009 we agreed a royalty free voluntary licence to enable Aspen to produce our ARV abacavir. This takes the total number of licensing agreements for ARVs in Africa to nine. The offer to grant licences for abacavir is open to all our licensees. In August 2007 we gave consent to enable a Canadian company, Apotex, to manufacture a generic fixeddose combination ARV, containing two molecules over which GSK has patent rights, for the treatment of HIV/AIDS in Rwanda. This consent was granted under Canada¶s Access to Medicines Regime which reflects the WTO µ31f¶ agreement. This enables governments to authorise the production of certain patented medicines for export. GSK agreed to waive royalties on the basis that Apotex¶s triple combination generic ARV will be supplied on a not-for-profit basis. Our licensees supplied 279 million tablets of their versions of Epivir and Combivir to Africa in 2007. This represents more than 50 per cent growth over 2007, and 130 per cent more than in 2006. We welcome this trend as it gives customers in sub-Saharan Africa greater choice and contributes to better security of supply. We have granted a VL to Simcere, a Chinese manufacturer, granting them the right to manufacture and sell zanamivir (Relenza) containing products in China, and to sell in a number of other countries including all 50 of the least developed countries. Zanamivir is an anti-viral which can help treat influenza and the VL was driven by a specific concern to help ensure sufficient supplies in the event of a global flu pandemic. Collaboration with local manufacture significantly reduces disease burden of rotavirus ± Brazil
We pursue initiatives that have both high public health impact and are commercially viable. An example of this can be seen in the implementation of universal mss vaccination (UMV) programmes in Brazil against rotavirus. GSK and the Brazilian vaccine manufacturer Fiocruz have had a long-standing partnership for the production of vaccines for diseases causing high mortality and morbidity such as polio, Haemophilus influenzae type b (Hib), measles, mumps, rubella and most recently rotavirus. The partnership between GSK and Fiocruz supports all of Brazil¶s requirements for universal mass vaccination against rotavirus with the Rotarix vaccine. Despite incomplete coverage, the vaccination programme has significantly improved public health: A 29 per cent reduction of all hospitalisation due to acute diarrhoea of any aetiology in 2007 An 85 per cent reduction of rotavirus-related hospitalisations 1 A reduction in diarrhoea outbreaks due to rotavirus in Smo Paulo from 36 per cent in 2004 to 8 per cent
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in 2008 A reduction in the proportion of cases of gastroenteritis caused by the rotavirus from 88 per cent in 2004 to 1 per cent in 2008 The rotavirus vaccine is expected to lead to 703 avoided deaths (75 per cent reduction) and 1.7 million avoided cases (54 per cent reduction). 1. Brazilian Ministry of Health statistics
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Access to medicine Developed countries
Corporate Responsibility Report 2008 Developed countries Approach
Performance
Access to medicines is not only an issue for the developing world. Even in developed countries some patients cannot afford the medicines they need. This is a particular problem in the US where many people do not have health insurance and there is limited public health provision. We have developed Patient Assistance Programs (PAPs) and discount savings cards in the US and we have introduced discount cards in some middle-income countries.
Programmes in the US Our Patient Assistance Programs (PAPs) and discount savings cards provide prescription medicines to uninsured patients in the US free or at minimal cost. GSK operates several programmes, including Commitment to Access, which covers cancer treatments, and Bridges to Access, which covers other medicines for outpatients. Patients are registered trough one phone call from a patient advocate and receive medicine at their local pharmacy or by mail order. GSK Access provides extra help for low-income senior and disabled patients enrolled in Medicare Part D. This programme provides free medicines for eligible patients who have spent $600 or more on prescription medicines during the current year, and whose income is between 135 per cent and 250 per cent of the Federal Poverty Level. The Federal Poverty level is about $11,000 for a single person, $14,500 for a couple and $22,000 for a family of four. We are a member of Together Rx Access, an industry programme which gives uninsured US citizens 25 to 40 per cent discounts on medicines from GSK and seven other pharmaceutical companies. The programme is open to people who earn up to four times the federal poverty level. Nearly two million Americans are enrolled in Together Rx Access. We are also working with governments and employers in the US to find new ways to address the problem of chronic diseases while reducing healthcare costs
Discount cards in other countries GSK has introduced discount cards in Lithuania and Ukraine to enable low-income patients with chronic diseases such as asthma to obtain prescription medicines at a discount price.
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Home Responsibility Access to medicine Developed countries
Corporate Responsibility Report 2008 Developed countries Approach
Performance
Programmes in the US In 2008, more than 415,000 patients received GSK medicines worth over 56 million through our US programmes. The value of our medicines is calculated using an average cost of goods rather than the wholesale acquisition cost (WAC) that we have used in previous years. This new approach to valuing medicines more accurately reflects the true cost to GSK and is therefore more transparent. We believe we are the first pharmaceutical company to adopt this practice. The number of patients using our largest patient assistance programmes declined by eight per cent compared with 2007. This is due to a decline in sales for Avandia and generic substitution for Coreg and Paxil. There may also have been an increase in the number of people without insurance delaying visits to the doctor. This year more than 8,000 patients received over 21,000 30-day prescriptions of GSK medicines through the Together Rx Access programme, giving patients discounts of more than $1.2 million. Since its inception in 2002, Together Rx Access has given nearly two million patients savings totalling $80 million across a wide range of products.
Discount cards in other countries In Lithuania, our Orange Card gives senior citizens and the disabled a discount of up to 60 per cent on the patient co-payment on all GSK prescription medicines. So far more than 60,000 patients have applied for an Orange Card and over 450 pharmacies (30 per cent of the pharmacies in Lithuania) are registered to participate. In 2008 the total discount given was 450,000. Our Orange Card in Ukraine gives significant discounts to all asthma and chronic obstructive pulmonary disease patients who need financial support for purchasing Seretide, our inhaled treatment for asthma and chronic obstructive pulmonary disease. In 2008 more than 19,000 patients received e-Orange Cards and 326 pharmacies were registered to participate in the programme. In 2008 the total discount given on GSK products was 658,000.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Access to medicines Pricing our medicines
Corporate Responsibility Report 2008 Pricing our medicines Prices for newly approved medicines are determined on a country-by-country basis. In some countries, prices are negotiated directly with governments or other payers, for example sickness funds and private health insurers. In others, manufacturers are free to set their own prices subject to other kinds of government controls. Pharmaceutical R&D is a lengthy and expensive process. To develop one successful medicine or vaccine it can take, on average, ten to twelve years and typically costs around $1.2 billion 1. For every product that reaches the market, thousands do not make it through the research process. We seek to ensure that the price of our new products reflects: Their clinical value to patients in terms of improved therapy, better safety and fewer side effects The high risks associated with R&D The need for a fair return on investment Affordability for our customers Ultimately, national price regulation will often amount to a balancing act between managing public healthcare budgets, enabling patient access and rewarding innovation and R&D investment. We sell our medicines to wholesalers and pharmacies, not directly to patients. These intermediaries often add their own price mark-ups to pharmaceutical products, and in addition duties and tariffs may be imposed on imported products. This affects the price paid by the end customer, for example national health services, hospitals and patients. 1. Tufts Center for the Study of Drug Development
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Access to medicines Intellectual property
Corporate Responsibility Report 2008 Intellectual property Intellectual property (IP) refers to creations of the human mind. There are laws in most countries to stop those creations being used by others. These include patents, copyrights and trademarks. At an international level, IP is protected through the World Trade Organization¶s (WTO) Trade Related Aspects of Intellectual Property Rights Agreement, commonly known as TRIPS. Patents and other IP rights play a vital role in encouraging the innovation needed to develop new treatments for many of the most serious and life-threatening diseases. We invest considerable time and money to develop each new pharmaceutical product - an average of $1.2 billion 1 and 10-12 years per product. For every 5,000 to 10,000 compounds tested, an estimated five reach clinical trials and only one reaches the market 2. If a new product could immediately be copied and sold by others, we would not be able to continue to fund new research. This would discourage innovation and limit research into newer and better medicines and vaccines. In relation to the healthcare crisis in the developing world, intellectual property, specifically patents, has been criticised for two broad reasons. Opponents claim that: The market-driven IP-based R&D system has led to a mis-prioritisation of R&D resources. This means that R&D prioritisation is based on developed world market opportunities rather than on unmet medical need. This has led to an R&D deficit into diseases of the developing world IP has acted as a barrier to access. This has two facets: firstly patents have led to monopoly pricing and have prevented generic competition being able to drive prices down. Secondly, patents have acted as a barrier to follow-on innovation such as the development of fixed-dose combinations We believe that these concerns have been overstated, but we recognise that we need to seek new approaches to IP to help tackle the healthcare crisis. We believe that the IP system is compatible with R&D into diseases of the developing world. GSK and others in the industry have expanded research into neglected diseases in recent years. In November 2008 the international trade association, the IFPMA, published data that showed that the number of medicine and vaccine projects undertaken by companies with product development partnerships or on their own had increased to 67, up from 58 in November 2007 3. We believe that patents are a minor issue in preventing people in the developing world from getting access to medicines. There is little or no patent protection for many vital medicines such as treatments for malaria, tuberculosis and diarrhoeal diseases, which kill millions of people a year. Over 95 per cent of the medicines on the World Health Organization¶s (WHO) Essential Medicines List are not patent protected anywhere in the world, yet the WHO says that one-third of the world¶s population does not have regular access to these drugs. In Africa and parts of Asia this figure rises to two-thirds of the population. Poverty is the biggest barrier to effective healthcare in the developing world because it is usually associated with a poorly developed healthcare infrastructure with little or no access to doctors and hospitals. The significant barriers that stand in the way of access to medicines in the developing world must be tackled as a shared responsibility by all sectors of global society. However, traditionally we have only allowed access to our intellectual property in very controlled situations. We are now exploring ways to be more flexible with our intellectual property that relates to neglected diseases.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
IP¶s primary objective is to incentivise and reward research. However, there are a number of neglected tropical diseases, such as leprose and cholera, where there is a serious lack of research, for a variety of complex reasons. We need to explore how to address this gap, including the use of IP. One approach might be for a patent pool to encourage more research into neglected tropical diseases. GSK is placing over 500 granted patents and over 300 pending applications, relating to approximately 80 patent families, in a pool to help others to develop potential medicines for neglected diseases. In addition to providing access to these patent filings, GSK will set out a mechanism to enable third parties to request access to other intellectual property and know-how about its medicines which may help researchers to develop new medicines for neglected tropical diseases. The aim of any such pool must be to encourage research that would otherwise not happen. If, as we hope, something new comes out of such research, then the full benefits must go directly to the LDCs. Such a pool has to be voluntary, so as to foster an atmosphere of cooperation and to encourage others to join. A pool is one mechanism we are exploring to achieve these aims. We will also consider new ways of stimulating research. We will continue to defend our IP robustly outside the pool. Our business is sustained through being rewarded for the discovery and development of innovative medicines. However, in the poorest countries we plan to be much more flexible and will develop our work in this area throughout 2009. Intellectual property laws can help prevent the distribution of counterfeit products, which present a serious health risk for patients. 1. Tufts Center for the Study of Drug Development 2. Pharmaceutical Industry Profile 2008, Washington DC, PhRMA March 2008 3. www.ifpma.org/News/NewsReleaseDetail.aspx?nID=10975
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Home Responsibility Access to medicines Intellectual property WTO and TRIPS agreement
Corporate Responsibility Report 2008 WTO and the TRIPS Agreement Intellectual property (IP) rights are protected globally by the World Trade Organization¶s (WTO) Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS). The TRIPS Agreement was signed by all WTO member countries in 1994 and covers all types of IP including patents, copyright and trademarks. It sets minimum standards for IP rights in all WTO member countries. The Agreement covers all areas of business and society including software, music and the arts, and is designed to encourage innovation in all business sectors. Developing countries have been given extra time to comply with TRIPS. Some countries, for example India, had until 2005 to introduce patents for pharmaceuticals. The 50 least developed countries of the world, for example Rwanda and Gambia, have until 2016 to comply with the Agreement for pharmaceuticals, and until 2013 for all other sectors.
Patents, TRIPS and access to medicines There have been concerns that patents and the TRIPS Agreement restrict access to medicines for people in developing countries, by making it difficult for them to obtain cheap generic versions of important drugs such as those used to treat HIV/AIDS. However, the TRIPS Agreement contains a number of public health safeguards that have been clarified by the WTO. Concerns over TRIPS and access to medicines were addressed in 2001, at the WTO ministerial conference in Doha, when WTO ministers confirmed that IP protection is important for the development of new medicines and that it does not and should not restrict members¶ rights to protect public health. They also agreed that the TRIPS Agreement could and should be implemented and interpreted in a way that supports public health and promotes access to medicines. This understanding was captured in the Doha Declaration on TRIPS and Public Health (the Doha Declaration), which confirmed the rights of member countries to use the flexibilities in TRIPS such as compulsory licences to protect public health priorities. Compulsory licensing allows governments to issue a licence so a patented product can be manufactured without the consent of the patent owner. The WTO members further agreed to modify the TRIPS provisions relating to compulsory licensing in August 2003 so that countries unable to produce pharmaceuticals domestically can import patented products made under compulsory licences abroad. This provision was confirmed as an amendment to the TRIPS agreement by the WTO in December 2005. GSK supports the Doha Declaration and the agreement on compulsory licensing. We are committed to playing a key role in the access crisis.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Access to medicines Intellectual property Intellectual property rights in brief
Corporate Responsibility Report 2008 Intellectual property rights in brief Patents A patent gives the inventor of a new product the exclusive rights to manufacture, use, sell or import that product or the process used to make it. These rights are granted for a set period, generally 20 years. The term of the patent runs during the lengthy research and development (R&D) period, and often only five to eight years of the patent remains once a product is marketed. Some countries have extended the patent term to compensate for the long R&D process. Patents are granted on the condition that the inventor publishes a full description of the invention, which would allow someone else to manufacture the product. This helps to build scientific understanding and encourage further research and innovation.
Trademarks A trademark is a brand name, word, phrase, symbol or design, or a combination of these, that identifies and distinguishes a product or company. The owner of a trademark can prevent its use by a third party. Trademarks enable our customers to tell our products from those of our competitors and provide reassurance of quality and the origin of the product. They are therefore a vital part of our marketing.
Data exclusivity Before we can sell a new product we must prove that it is effective and safe to use. All our products are rigorously tested through clinical trials and other medical research. The results of this research are submitted to governments on a confidential basis. Data exclusivity means that governments cannot use or disclose these data for a fixed period. This ensures that other companies cannot benefit from our research for free - for example to demonstrate the safety and efficacy of generic copies of our products. In the interest of facilitating timely market access and the need to avoid repetitive animal testing and human clinical trials, competitors may refer to our data after expiration of the period of exclusivity.
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Home Responsibility Access to medicines The future
Corporate Responsibility Report 2008 The future Increasing access to medicines is a global challenge. While encouraging progress has been made in some areas, significant problems remain and new issues are likely to emerge. For example: The continued need for a significant scale-up of treatment for HIV/AIDS in sub-Saharan Africa, in resourcepoor settings A potential global flu pandemic The healthcare needs of poor people in middle-income countries The growing impact of non-communicable diseases such as diabetes in poor and rich countries The death of 2.5 million children each year from vaccine-preventable diseases In 2009 we will implement programmes in a number of areas to help address these challenges: Intellectual property ± we will explore ways to be more flexible with our intellectual property rights as they relate to neglected diseases, including exploring the idea of patent pools. We believe that this could speed up the development of new medicines and will encourage other pharmaceutical companies to adopt a similar approach. Update August 2009
On 24 March 2009 we launched an LDC Neglected Tropical Disease Patent Pool website which enables interested stakeholders to: Access a list of GSK¶s patent filings on small molecule pharmaceuticals for the treatment of neglected tropical diseases (NTDs). Organisations can apply for licences in areas where we are not developing treatments; Request licences to research and develop a treatment for an NTD using a GSK patented technology for small molecules that we are not currently developing; Get our help with problems arising in their research and development into small molecule therapeutics to treat NTDs in Least Developed Countries. In July 2009, the US biotechnology group Alnylam became the first company to follow GSK and contribute some of its patents to the pool. Pricing ± we will improve transparency in our pricing policies and implement our new pricing policies in least developed countries and continue to evolve new approaches to increase affordability in middleincome countries Update August 2009
On 1 April 2009 we implemented price reductions on our patented products in the Least Developed Countries (LDCs). Our commitment is that all GSK patented products in these countries will now cost less than 25 per cent of their price in the referenced developed countries.
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We reduced prices for seven patented brands (110 individual product lines and formulations) by an average of 45 per cent. In some countries prices were not reduced immediately due to regulatory processes such as needing to obtain government authorisation, however the price reduction process was initiated. We also cut prices in some non-LDC markets in East Africa and Francophone West Africa to reduce the risk that products would be diverted from the LDCs and sold in these wealthier countries, thereby reducing their availability in the LDCs. Research ± we will evaluate opportunities to expand our Tres Cantos µdiseases of the developing world¶ research centre into a world-class, global centre of excellence. We will do this by encouraging partnerships with governments, NGOs and other pharmaceutical companies. Update August 2009
We have appointed a leadership team and are working with partners to extend the capacity and scope of the Tres CantosIDFLOLW\:HDUHFUHDWLQJDPRUHRSHQDQGFROODERUDWLYH way of working and providing the IDFLOLWLHVDQGVXSSRUWQHWZRUNQHHGHGIRUYLVLWLQJVFLHQWLVWVWRIRUPGUXJGLVFRYHU\SURMHFWWHDPVZLWK GSKVFLHQWLVWV Healthcare services ± we will seek to partner with governments and other stakeholders to help to strengthen healthcare infrastructure and services Update August 2009
Through our reinvestment initiative GSK will support the governments of five LDCs in addressing priority healthcare challenges, to remove some of the barriers to quality healthcare and to strengthen health infrastructure. This will be achieved through targeted partnerships that will increase access to essential PHGLFLQHVDQGEDVLFKHDOWKFDUHVHUYLFHV7KHZRUNZLOOEHJLQEHIRUHWKHHQGRI In four of the LDCs - one each from the GSK regions of East Africa, Southern Africa, Anglophone West Africa and Francophone West and Central Africa - we will be expanding our maternal and child health activities, with specific focus on children under five through the Integrated Management of Childhood Illness programme. In one additional LDC we will be piloting a new Child Family Wellness (CFW) model. The CFW microfranchising model involves building a network of micro pharmacies and clinics to improve access to essential medicines, basic healthcare and prevention services for children and families. The work will use business models that maintain standards, are readily scalable, and achieve economies of scale. GSK is currently working with an NGO, the HealthStore Foundation, which has implemented the model in Kenya, to run viability studies in at least two LDCs in East Africa. We will then select one country in which to implement the initiative. In July 2009 we announced new commitments to fight HIV/AIDS in Sub-Saharan Africa, with a special focus on the care and treatment of children. They include 10 million seed funding to support a public private partnership for research and development of new HIV/AIDS medicines for children, a commitment to seek collaborations with other companies to develop fixed -dosed anti-retroviral combinations, and the creations of a 50m Positive Action for Children Fund .
We are working with the main industry associations on new initiatives to increase R&D and improve access. The first outcome of this activity was the announcement in January 2008 of a grant of $1 million by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) to the Special Programme for Research & Training in Tropical Diseases (TDR), co-sponsored by UNICEF, UNDP, the World Bank and the WHO. The grant will support TDR¶s development of new medicines to combat diseases that disproportionately affect poor people living in developing countries. Other activities include plans to establish a pilot industry consortium to focus on developing new targets (molecules that can prevent or interrupt disease progression) against diseases of the developing world. Update August 2009
In April 2009 we announced our intention to combine the GSK and Pfizer HIV businesses to create a new
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companyGHGLFDWHGWRWKHGLVFRYHU\DQGGHOLYHU\RI+,9WUHDWPHQWV%\FRPELQLQJWKHEXVLQHVVHVZH will create a specialist unit that is more sustainable and broader in scope than either company¶s individual business. The new company will particularly look to improve treatments and formulations for children living with HIV. We will continue to offer HIV medicines at not-for-profit prices in the world¶s poorest countries, and to issue new voluntary licences to diversify production and expand capacity in these markets. The new company will be responsible for delivering on the commitments announced by GSK in July 2009.
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Home Responsibility Access to medicines Response to assurance recommendations
Corporate Responsibility Report 2008 Response to assurance recommendations Bureau Veritas assured the Access to medicines section of our CR Report 2007 (see details on pages 49-50) and made recommendations for how we could improve our reporting on access to medicines in four key areas. Below we report these challenges and how we have responded: 1. Vision ± GSK could further enhance and communicate its overall vision and strategy on access to medicines. This should demonstrate a holistic, long-term approach; articulate the business case; provide context and explain how it is integrated into its overall business strategy. GSK response: In June 2001, GSK published µFacing the Challenge¶ which summarised our approach and contribution to improving access to medicines, and the principles underlying our approach. In 2008 Andrew Witty assumed the position of CEO of GSK and instigated a review of our approach to access to medicines. In a major speech at Harvard University in February 2009, Andrew Witty set out our approach to improving access to medicines in the developing world and the initiatives we will implement in 2009. 2. Governance ± GSK should provide greater detail on the governance, accountability and management structures for access to medicines and the relationship with external stakeholders. GSK response: Abbas Hussain, President of Emerging Markets at GSK, leads our access efforts which are also reviewed by the Corporate Executive Team, GSK¶s most senior management team, and by the Corporate Responsibility Committee of the Board. In 2008, we have continued to engage with stakeholders on access issues including the ATM Index and participating in the development of a report on GSK¶s approach by Paul Hunt, the UN Special Rapporteur on the Right to Health. 3. Transparency ± GSK provides significant information and case studies but should also consider how to provide greater transparency on the impacts of its access to medicines initiatives and how to put these into context in relation to its overall operating model. GSK response: Assessing the impacts of our access to medicines programme is a challenge. We report data on the number of tablets shipped through our preferential pricing programmes and voluntary licence agreements, but it is difficult to translate these figures into numbers of patients receiving treatment as we are not involved in healthcare delivery. Our medicines are also used in combination with medicines supplied by other pharmaceutical companies, so simply converting our shipments into patient numbers would be misleading. The Accelerating Access Initiative (AAI), a public-private partnership working to combat HIV/AIDS, calculates treatment rates using medicines supplied by the nine R&D-based pharmaceutical companies involved in the partnership. It estimated that by December 2007, around 875,000 patients in developing countries were receiving at least one ARV treatment supplied by the companies. Where we are able to generate robust data on the impact of our programmes we will seek to do so. For example in October 2008 significant data on the lymphatic filariasis (LF) elimination programme was published in the Public Library of Science (PLoS) Journal of Neglected Tropical Diseases 1. The study found that, in the ten years since GSK¶s commitment, the LF elimination programme has prevented 6.6 million children from acquiring LF and stopped a further 9.5 million infected people from progressing to more debilitating stages. All of this is the result of the fastest-growing drug administration programme in public health history, delivering what the study calls the µbest buy in public health¶.
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4. Measuring performance ± linked to transparency, GSK should consider how to provide relevant indicators that demonstrate the implementation of a long-term strategy and promote comparisons across the industry. GSK response: We welcome comparisons across the industry on performance on access to medicines; however, since approaches differ significantly between companies, making meaningful comparisons is a challenge. What is right for one company may not be right for another. A method of ranking companies on their approach to access to medicines was developed during 2008, the Access to Medicines Index. GSK was ranked top in the first Access to Medicines Index, published in 2008. The Index rates companies according to their performance on eight criteria: management, influence, research and development, patenting, capacity, pricing, drug donations and philanthropy. We are pleased that our efforts to make our medicines more available have been recognised by the Index. Additionally, during 2008 we were asked by Paul Hunt, the UN Special Rapporteur on the Right to Health, to contribute to a report he was preparing on GSK¶s approach to access to medicines. We cooperated fully and a number of senior executives, including our former CEO, Dr JP Garnier, and our Chairman Sir Christopher Gent, were interviewed. We expect the report to be published in the first half of 2009. 1 www.plosntds.org/article/info:doi/10.1371/journal.pntd.0000317
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Home Responsibility Access to medicines Case studies
Corporate Responsibility Report 2008 Case studies Potential malaria vaccine Malaria kills more than one million people a year worldwide and makes millions more sick, most of them children living in sub-Saharan Africa. The international community urgently needs a safe and effective vaccine to control the disease. A vaccine, even with a partially effective profile, is a necessary component of a comprehensive malaria control programme and could potentially save hundreds of thousands of lives a year. Our malaria vaccine candidate RTS,S is the most clinically advanced malaria vaccine candidate in the world. Since its discovery by GSK scientists in 1981, GSK has invested over $300 million of its own resources in progressing RTS,S to phase lll trials. A full set of clinical trials for a successful vaccine candidate can take 10 to 12 years, involve 50,000 to 100,000 volunteers, and cost $500 million or more. Few vaccine candidates survive this rigorous process, which is one reason why pharmaceutical research and development is so expensive. Creating a malaria vaccine for young children and pregnant women - one of the most important vaccine-development challenges today - is no exception. In January 2001, GSK and MVI (PATH Malaria Vaccine Initiative), with support from the Bill & Melinda Gates Foundation, entered into a public-private partnership to develop an RTS,S-based vaccine for infants and children living in malaria endemic regions in sub-Saharan Africa. The clinical development of RTS,S is conducted by the Clinical Trial Partnership Committee, a collaboration of leading African research institutes, Northern academic partners, MVI and GSK with support from the Malaria Clinical Trial Alliance. To date, GSK has invested over $300 million of its own resources to develop the vaccine. In December 2008, the New England Journal of Medicine published results of two separate studies demonstrating that the malaria vaccine candidate provides both infants and children with significant protection against malaria. In infants, data showed for the first time that the vaccine candidate can be administered as part of existing African immunisation programmes 1. In children aged five to seventeen months, the candidate RTS,S/AS01 reduced the risk of clinical episodes by 53 per cent over an eight -month follow-up period 2. RTS,S is now entering pivotal phase lll studies, which will be the world¶s largest malaria vaccine trial to date, involving 16,000 participants in 11 centres in Africa. Most of the places we are doing our trials have limited healthcare infrastructure. With partners we have therefore helped to set up these 11 clinics in seven African countries, with each training doctors, nurses and laboratory staff. We hope this infrastructure will remain long after the trials are completed. Update August 2009
The Phase III trial of the RTS,S malaria vaccine candidate started in Bagamoyo, Tanzania, in May 2009. The children who need this vaccine are among the poorest in the world. Price cannot be a barrier to access and we will work with supply organisations such as GAVI and UNICEF to ensure the price is set at the right level. We are also committed to working with the international community to mobilise the resources to fund the vaccine and the infrastructure needed to deliver it. 1. Abdulla S, Oberholzer R, Juma O, et al. Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med 2008;359:2533-44. 2. Bejon P, Lusingu J, Olotu A, et al. Efficacy of RTS,S/AS01E : clinical malaria in 5 to 17 month old children. N Engl J
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Extending our product portfolio in the developing world ± low- and middleincome countries In July 2008 GSK entered a partnership with the South African pharmaceuticals company Aspen. This is in line with our aim to grow a diversified business and operate in a way that is adapted to patient needs in low and middle-income markets. Aspen¶s product portfolio covers a broad range of therapy areas relevant to the disease profile in developing countries, including: analgesics (for pain relief), anti-hypertensives (for high blood pressure), bronchodilators (for the treatment of asthma), anti-bacterials, anti-gout agents, anti-inflammatory agents, anti-depressants, anti-fungal agents, anti-histamines (for the treatment of allergies) decongestants, gastro-intestinal agents and dermatologicals (to treat skin conditions). Through gaining access to Aspen¶s current portfolio and future pipeline, GSK will be distributing more products and medicines needed by those in low- and middle-income countries. The long-term nature of this collaboration ± initially beyond a 10 ten-year period ± also underlines GSK¶s philosophy of investing in a meaningful and sustainable manner in the developing world. In January 2009 we announced an agreement with UCB S.A. to acquire its current marketed product portfolio across certain territories in Africa, the Middle East, Asia Pacific and Latin America. As a result of the agreement, GSK will acquire several leading pharmaceutical brands in a number of disease areas. These include Keppra for the treatment of epilepsy and Xyzal and Zyrtec for the treatment of allergic rhinitis. The Aspen partnership and the UCB deal sit alongside the recent acquisition of Bristol Myers Squibb¶s mature pharmaceuticals businesses in Egypt and Pakistan and the two associated manufacturing facilities. Together, these deals will provide GSK with access to a renewable, high-quality and competitively priced pipeline of branded pharmaceuticals products that complements its existing portfolio of products, and will help drive patient access in low- and middle-income markets.
GSK vaccine eliminates Hib meningitis as a public concern in Uganda A national, four-year immunisation programme using GSK¶s TritanrixHB Hib vaccine has eliminated Hib meningitis as a public health concern in Uganda, according to the Global Alliance for Vaccines and Immunisations (GAVI) 1. Hib meningitis is a dangerous inflammation of the lining of the brain and spinal cord. GAVI, a public-private partnership that includes the World Health Organization and the World Bank and is supported by the Bill & Melinda Gates Foundation and others, says that the use of TritanrixHB Hib between 2002 and 2006 has reduced the number of incidences of the disease in Ugandan children to zero. The news follows similar results in Bangladesh, Kenya, Chile and the Gambia, as well as Britain and the US, where the vaccine was shown to cut the number of cases of Hib meningitis by at least 88 per cent in a threeto-five year period. Julian Lob-Levyt, Executive Director of GAVI, says the results are extremely positive. ³We can applaud a true success in controlling this deadly disease, which has too often claimed so many lives,´ he says. Though developed countries have largely eliminated the disease, Hib vaccine distribution has been slow in poorer parts of the world due to financial and logistical problems, as well as limited awareness of the disease. In Uganda, the government obtained GAVI support to use 16.5 million doses of 5-in-1 vaccines, giving protection against Hib, diphtheria, pertussis, tetanus and hepatitis B. According to a study published in The Bulletin of the World Health Organization, the vaccination programme in Uganda is now preventing almost 30,000 cases of severe Hib disease and 5,000 child deaths every year. "The introduction of Hib vaccine has completely changed the epidemiology of bacterial meningitis in Uganda," says Adeodata Kekitiinwa, a paediatrician at Kampala's Mulago Hospital, who co-authored the study. Hib kills about 400,000 children under the age of five every year, and is linked to around three million cases of illnesses that can result in long-term effects such as deafness, paralysis, mental retardation and learning disabilities. GAVI says that for every child with Hib meningitis in a developing country, there are thought to be five to ten others with Hib-related pneumonia, which is also preventable by vaccination. 1. GSK press release, March 2008
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Home Responsibility Access to medicines Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders Aren¶t your access programmes just a drop in the ocean, given the scale of the healthcare crisis in the developing world? The global healthcare crisis is extensive and complex, and the programmes of any single organisation are insufficient on their own. Political will and the effective investment of extra resources are required to support healthcare development and build infrastructure. GSK and the wider pharmaceutical industry do not have the mandate, expertise or resources to address the problem alone. Without a global partnership to address the issues, the efforts of any individual stakeholder will be inadequate. Primary responsibility for dealing with the crisis lies with governments, which can call on international agencies and NGOs for support. GSK is committed to playing a full part in partnerships with these organisations and is seeking new ways to make a contribution. We focus our access programmes on specific areas where we think we can make a real difference. For example, we research and develop medicines and vaccines that are particularly needed in developing countries, and make them available at lower prices through preferential pricing arrangements and voluntary licences. We are also working to identify other ways that we can support the strengthening of healthcare systems through expanding our pricing policies, by being more flexible with our intellectual property and by investing in healthcare infrastructure. Why are your medicines so expensive? Wouldn¶t the most responsible thing you could do be to cut the price of your medicines? Improving affordability of our medicines is important and we are taking steps to do more in this area. However, as Kevin de Cock, the Head of HIV/AIDS at the WHO, has said ³If you work in these countries it is very obvious, very quickly, that the elephant in the room is not the current price of drugs. The real obstacle is the fragility of the health systems, particularly in Africa.´ Therefore, unless action is taken to address the underlying problems of poverty and healthcare infrastructure, reducing prices alone will not solve the problem. We have to price our products at a level that enables us to continue to fund R&D and discover the medicines and vaccines of the future. We also need to make enough profit so that GSK remains an attractive prospect for investors. While we want to make a difference, cutting prices too far would mean we undermine the longterm profitability and therefore sustainability of our business. Getting this balance right isn¶t easy. The pricing pilots we have been conducting in recent years have taught us that there are no easy solutions. We believe that the new pricing policies we announced in 2009 will help to improve affordability for the world¶s poorest and we will continue to learn and refine our approach as we roll out these policies. Why are so few people with HIV/AIDS receiving treatment in the developing world? There has been important progress in this area and now over three million people in the developing world are receiving treatment with life-saving anti-retrovirals. This has led to a decline in deaths caused by AIDS despite an increase in the number of people living with HIV. However, there is much more to do. The core issue is that many people in developing countries do not have access to effective healthcare services and are therefore unable to access medicines. Due to poverty, many clinics and patients are unable to pay for even the cheapest basic generic medicines. The access issue is complex and multifaceted. Pricing of medicines is important, but we believe there are many other more significant barriers. Other factors that play a part are inadequate healthcare resources, lack
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of clinics and hospitals, poor distribution networks, low numbers of trained healthcare providers, high levels of patient illiteracy, significant stigma and discrimination, and a lack of political will and inadequate prioritisation of health in government budgets. This is why in 2009 we announced that 20 per cent of the profits we make from selling medicines in least developed countries will be reinvested into projects that strengthen infrastructure and widen access. Why don¶t you just donate your AIDS products to the world¶s poorest? In common with many other stakeholders, including Oxfam and the WHO, we do not believe that donations of ARVs offer a solution to the AIDS pandemic or for healthcare problems in the developing world more generally. This is a widespread crisis and one which requires a long-term commitment to treatment. This commitment cannot be assured through donations. As WHO Director General Margaret Chan has said ³Health systems are the tap root for better health. All the donated drugs in the world won¶t do any good without an infrastructure for their delivery.´ In some limited circumstances donations may be appropriate, for example, in disease elimination efforts such as the Global Alliance to Eliminate LF. We have in the past donated ARVs to support UNICEF Prevention of Mother-to-Child Transmission programmes, and we continue to support collaborative clinical trials to assess the appropriate use of ARVs in resource poor settings. Why doesn¶t GSK extend its not-for-profit prices to middle-income countries? Middle-income countries are not automatically eligible for the not-for-profit prices offered to Least Developed Countries (LDCs) and sub-Saharan Africa. However, they can access medicines at reduced prices. Middleincome countries can secure preferential prices through bilateral discussions with GSK and we are looking at ways to make this process easier. We are focusing our preferential prices on the countries where the need is greatest and resources are most limited. It is widely accepted that in terms of support for improving healthcare services, these are the LDCs (as defined by the UN) and sub-Saharan Africa. We have been conducting pricing pilots in middle-income countries in recent years which have taught us that there are no easy solutions. However, we will continue to develop policies in middle-income countries that are more flexible on price and therefore more closely reflect a country¶s ability to pay. Why don¶t you allow middle-income countries to buy your ARVs from generic manufacturers? We have granted eight voluntary licences for our ARVs to African generic companies. Under these arrangements they can supply a number of middle-income countries in Africa. Middle-income countries are generally more economically developed than the least developed countries and often have a large and affluent middle-class. These countries also have large numbers of people living in extreme poverty and healthcare demands often outstrip available resources. We recognise that many middle-income countries need assistance. However, we believe a different approach is needed from the one we take in the world¶s poorest countries and we will continue to refine our approach during 2009. Our offer to supply products at not-for-profit prices in the world¶s poorest countries is only sustainable if we can continue to make an adequate return on them in wealthier markets. Many middle-income countries are also growing commercial markets for GSK and represent an important source of future business for our industry. Our response in these markets must therefore be one that balances our commercial objectives with our global commitment to work with governments and other stakeholders to ensure that our medicines and vaccines reach as many as possible of those who need them. We believe governments in middle-income countries can improve access by increasing investment in disease prevention and healthcare; eliminating taxation and tariffs on medicines; and creating an environment which allows a strong private healthcare sector to co-exist with public healthcare provision. We are working with governments to find creative ways to meet these goals. Why don¶t pharmaceutical companies work together to increase access to medicines? We are working with the main industry associations on new initiatives to increase R&D and improve access, and we will continue to seek new opportunities to work in collaboration with all stakeholders, including other companies.
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Home Responsibility Research practices
Corporate Responsibility Report 2008 Research practices We are committed to focusing on the patient in everything that we do. Our R&D pipeline is central to our ability to meet patients¶ needs. High ethical standards in R&D are key to protecting participants in our clinical research, ensuring the quality of our research, and maximising the benefits and minimising the risks of our products. High ethical standards are also essential for us to obtain regulatory approval for new medicines, and for patients and doctors to put their trust in our research programmes and products. We aim to make our medicines as safe as possible by evaluating the risks and benefits at every stage from initial research, through to clinical trials and then after a new product is approved for sale. We are committed to high levels of transparency about the results of our clinical research and use a number of reporting channels so that those who evaluate the efficacy and safety of our medicines or use our medicines can make informed decisions on their use. We also recognise that biomedical research can raise ethical concerns including: The use of emerging technologies, such as cloning and the use of stem cells Animal research The storage and use of human tissue The protection of personal information about research participants We participate in discussions on research practices and we regularly engage with academic scientists, regulators, policy makers and other stakeholders on related issues.
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Home Responsibility Research practices Emerging technologies
Corporate Responsibility Report 2008 Emerging technologies Research capabilities are expanding through the development of technologies related to areas of research such as stem cell and genetic research. These advances are helping to expand the boundaries of scientific understanding. These technologies hold out hope for new ways to treat serious diseases as well as better ways to evaluate the risks and benefits of the medicines we develop. For example, advances in genetic research are beginning to enable identification of patients who are more likely to experience a side effect from a medicine. We use emerging technologies in our research and we are involved in collaborative research on these technologies. We recognise that research using these emerging technologies can give rise to ethical concerns. Here we outline our involvement and approach to: The use of cloning technologies The use of stem cells Genetic research Collaborative research on emerging technologies Use of transgenic animals
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Home Responsibility Research practices Emerging technologies Cloning technology and stem cell research
Corporate Responsibility Report 2008 Cloning technologies and stem cell research Cloning technologies GSK uses cloning technologies to replicate molecules and cells for research. These technologies have provided better ways to evaluate compounds, enabling greater insight into the risks and benefits of potential medicines and helping to create better medicines for patients. This technology is a fundamental component of medicine discovery and development. GSK does not clone animals. We do not use cloning technologies with the intention of reproducing entire human beings and we do not see a medical or research case for doing so. Read our position statement on cloning technologies and stem cell research.
Stem cell research We recognise the importance of being clear about our approach to stem cell research and the standards we apply in this area of research. We updated and published our approach to stem cell research in 2008. It sets out the standards we apply when using stem cells, including when using embryonic and foetal stem cells. In 2008, we began a five-year collaboration with the Harvard Stem Cell Institute (HSCI). This includes a $25 million investment to support research at Harvard University and a number of affiliated hospitals in the areas of neuroscience, heart disease, cancer, diabetes, musculoskeletal diseases and obesity. The collaboration is overseen by a joint steering committee made up of HSCI and GSK scientists and managers. We are also a founding member of the Stem Cells for Safer Medicine (SCSM) initiative in the UK. SCSM aims to develop a bank of human cell lines to be used in early medicine discovery. This will provide early identification and elimination of potential toxicity issues before clinical testing. A number of public sector organisations are contributing to the initiative including the Department of Health, the Department for Innovation, Universities and Skills, the Scottish Government, the Medical Research Council and the Biotechnology and Biological Sciences Research Council. An independent ethics review board is being established to review the SCSM ethics policy. Read more about how we are collaborating in research on emerging technologies.
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Home Responsibility Research practices Emerging technologies Genetic research
Corporate Responsibility Report 2008 Genetic research Genetic variation underpins many aspects of human health, such as why some people get certain diseases while others do not, at what age diseases manifest themselves and how fast they progress. In the last year, more genes have been identified for common human diseases than in the cumulative history of genetics research. Diseases for which genetic risk factors have been identified include diabetes, heart disease, obesity, several cancers, asthma and a number of autoimmune disorders. GSK researchers have led or contributed substantially to several of these findings. These discoveries, and others to come, offer promise for the development of innovative new medicines. Individual differences in genes also affect how people respond to medicines. Differences in genes can explain why some patients experience adverse responses to certain medicines while others enjoy benefits without such effects; why some individuals require greater doses of medicines than others to achieve the same level of efficacy; and why some groups of individuals respond well to treatment while others do not. GSK scientists are using emerging genetic information to study how medicines can be differentiated to suit groups of patients with different genetic characteristics. Successful genetics research requires close collaboration between organisations with different areas of expertise. We are engaged in a number of research projects involving academic partners, regulatory agencies and other pharmaceutical companies. Read about our involvement with the Serious Adverse Events Consortium (SAEC) collaboration. We recognise that people have concerns about some of the applications and standards of genetic research. We aim to address these concerns by being transparent about how and why we conduct genetic research. Any genetic analysis during GSK clinical trials is only undertaken after seeking and obtaining informed consent from the patient. This procedure includes providing information on the purpose and scope of the research and who has access to the genetic research data. We believe that the pharmaceutical industry shares responsibility with governments for helping to identify and develop policy on genetic research. We refer to guidance from national and international groups to inform our genetic research activities such as the European Medicines Evaluation Agency, the US Food and Drug Administration and the Council for International Organisations of Medical Sciences.
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Home Responsibility Research practices Emerging technologies Collaborative research on emerging technologies
Corporate Responsibility Report 2008 Collaborative research on emerging technologies New scientific knowledge and technologies can be developed for application to medicine discovery and development through collaborative research that combines resources, expertise and know -how from several partners. The benefit of this research is often realised by making the results widely available to the research community. For example, we are an active participant in the Innovative Medicines Initiative (IMI) a public-private partnership set up by the European Commission and the pharmaceutical industry through the European Federation of Pharmaceutical Industries and Associations (EFPIA). The IMI will support and stimulate collaborative research in Europe involving pharmaceutical companies, smaller bioscience companies, academia, regulators and patient groups with the aim of removing barriers to the discovery and development of new medicines. Read more about our investment in R&D and new technologies. More on our partnerships and academic collaborations.
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Home Responsibility Research practices Animal research
Corporate Responsibility Report 2008 Animal research Approach
Performance & plans
Animal studies remain a small but vital part of our research.They are the only method that can demonstrate the effects of a potential new medicine in a living body before it is used in humans. In addition, research in animals can provide vital information about the causes of diseases and how diseases may develop. Safety regulations require us to test all new medicines on animals before they are tested in clinical trials using humans. Most vaccines have to be tested on animals each time a new batch is produced. Our non-medicinal Consumer Health products or ingredients, for example dietary supplements, are not tested on animals unless there is a specific demand from a regulatory authority or if we determine that a study is needed to support safe use. GSK does not conduct animal testing on our Nutritional Healthcare products or products classified as cosmetics, for example toothpastes marketed in the European Union. When animals are necessary for our research, we are committed to acting ethically, providing for the animals¶ health and wellbeing and practising good animal welfare.
Our approach GSK has animal research laboratories in Europe, Asia and the US. Some animal research is conducted by external contractors on our behalf, representing around six per cent of our total animal use. We estimate that animal research accounts for around five per cent of all GSK research expenditure. Almost all the animals used by GSK are rodents, mainly rats and mice. We also use rabbits, dogs, nonhuman primates, fish, ferrets, chickens, pigs, cats, sheep and goats. Together these account for just over one per cent and are listed in order of magnitude of use. Ultimately GSK would like to see the important benefits of research being achieved and applied to humans without the need for animals in research. We do not believe this can be achieved in the foreseeable future. Our goal is to use animals only when scientifically necessary, use as few as scientifically feasible and to minimise pain and distress. Therefore GSK remains committed to the 3Rs.
The 3Rs A key aspect of animal welfare is covered by what the biomedical community refers to as the three Rs (3Rs). These Rs are: Replacing research using animals with non-animal alternatives or species of the lowest possible order (phylogenetically) Reducing the number of animals used in experiments and still obtaining the same information as in a larger study Refining techniques to minimise pain and distress and maximise the welfare of animals Our scientists always try to devise experiments that do not require any animals. When that is not possible, the researchers will work with others to design an experiment so that we obtain the necessary information from the smallest number of animals possible, with the least effect on individual animals. We implement the 3Rs by using advanced scientific methods, training, raising awareness, and sharing and encouraging best practice. For example, we use ultrasound for imaging heart disease in rats and we have a forum for discussion on global principles for animal housing. Read more on recent GSK advances in replacing, reducing and refining animal use
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g
g
In addition we encourage a 3Rs culture at GSK through: Regular training for staff involved in the care and use of animals Review of study designs by an ethical panel which considers the 3Rs and whether alternatives to animal studies are possible prior to the approval of studies Refining techniques to minimise pain and distress and maximise the welfare of animals Our internal 3Rs website which champions advances in refinement, reduction and replacement of animal use in medicine discovery and development, and promotes their application across R&D A news bulletin on advances in the 3Rs which is updated on a rolling basis and is easily accessible from the 3Rs website Our internal Animal Welfare Awards for employees who have made outstanding advances in implementing the 3Rs
Non-human primates Our policy requires that studies involving animals must use the lowest possible order (phylogenetically) of animal appropriate for the research study. Occasionally, non-human primates may be the only animals where the anatomy and/or physiology of a disease is similar to that in humans. Sometimes only human and non-human primates will be affected by or respond to a potential medicine or vaccine; for instance, a new medicine may be based on a molecule produced by primates, including humans, and would be destroyed by the immune systems of other species. We therefore use non-human primates, only if no species of lower neurophysiological sensitivity is appropriate. The two most common non-human primates species used in research are macaques and marmosets. Of the animal research that we carry out, less than 0.5 per cent involves non-human primates.
Transgenic (genetically modified) animals Genetically modified animals, also known as transgenic animals, have been genetically adapted by scientists to create new characteristics. Most transgenic animals (over 95 per cent) used in biomedical research are mice. Transgenic strains of animals are developed to answer specific compound or disease-related questions as part of the medicine discovery process. For example, transgenic mice that model Alzheimer¶s disease have been fundamental in biological research, new compound development and target validation. The use of such transgenic models in mice can sometimes replace the need for studies in higher order animals.
GSK worldwide standards While recognising differences in country-specific regulations, GSK achieves worldwide standards by using core principles for the care of laboratory animals. These principles establish our basis for animal work conducted by or on-behalf of GSK. In addition, all GSK facilities and external laboratories conducting research on our behalf must follow all legal and regulatory requirements. In the UK these regulations are the responsibility of the Home Office. In Europe animal research comes under Directive 86/609/EEC and in the US is covered by the Animal Welfare Act 2006. We also continue to seek voluntary accreditation from recognised agencies such as the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALACi).
Communicating our approach Some people hold strong views on animal research and testing. We believe it is important to explain the need for animal research and testing and to be transparent about what we do. Many of our laboratories host visits from schools, colleges, animal welfare organisations and others. We engage regularly with animal welfare organisations and our investors, as well as contributing to the debate in the media.
Protest We accept the right of lawful protest against animal research as a part of a free society, but condemn the use of violence and intimidation by some who are opposed to animal use. We welcome the shift away from extremism to informed debate.
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Home Responsibility Research practices Animal research
Corporate Responsibility Report 2008 Animal research Approach
Performance & plans
The 3Rs The great apes family comprises gorillas, chimpanzees, orangutans and bonobos. One species of ape, Pan troglodytes, also known as the µcommon chimpanzee¶, has been used in biomedical research for over three decades. The other great apes are not used in biomedical research. In 2008 we took a voluntary decision to no longer carry out research in great apes. Read more in our position statements on the use of non-human primates and great apes in research. As well as the ban on the use of great apes, recent GSK advances in replacing, reducing and refining animal use include: Implementing a polio vaccine test at the bulk manufacturing stage that uses transgenic mice instead of non-human primates. These are mice that have been genetically altered to make them susceptible to the polio virus Decreasing the number of animals needed for vaccine testing. For example, we included an in vitro (nonanimal) test in the regulatory submission for our new vaccine against the Human Papillomavirus, Cervarix. This means that for many markets new batches of Cervarix will not need to be tested in animals Developing a transgenic mouse model that mimics an accelerated form of Alzheimer¶s disease to replace primates as a primary model for this disorder. Fundamental biological research, compound development and target validation have been carried out using this mouse model, facilitating greater understanding of this disorder and the potential for future therapies Implementing new technology to collect blood samples in animal studies. This approach enables analysis to be carried out on much smaller blood samples than traditional techniques. This enables quality data to be obtained using fewer animals Working with governments to change regulatory requirements so fewer animals are required for routine testing. A proposal to reduce animal testing originating from GSK¶s vaccines business was submitted to the European Vaccine Manufacturers Association and later presented to the European Directorate for the Quality of Medicines in 2007 Developing in vitro alternatives to safety tests which check the potential impact of pharmaceutical process materials on workers¶ skin and eyes. No animals have been used in the evaluation of dermal or eye irritation for worker safety purposes since 2006 Donating our collection of information on commonly used blood collection methods to the UK National Centre for the 3Rs (NC3Rs). Our donation was the founding part of the NC3R¶s blood sampling website. This UK site is used by many laboratory staff to choose the most appropriate technique for the humane and efficient sampling of blood Our internal Animal Welfare Award recognises work that is demonstrably above and beyond the very high standards of care, experimental design and implementation expected in GSK from all employees involved in animal experimentation. To receive the Award, the contribution should have tangible benefits in terms of one or more of the 3Rs and should make a difference to how animal experimentation is conducted at GSK or how animals are routinely cared for. Recent recipients of our internal Animal Welfare Award have been:
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A team in UK for implementing blood-spot technology in preclinical toxicokinetic (TK) studies. Using this technology meant researchers needed significantly smaller volumes of blood, which therefore meant fewer animals were needed for TK studies A member of the Neuroscience department for developing and assessing an alternative method of administering medicines to rats. This replaces the previous method that required restraint during dosing and allows us to train rats to drink the test substance directly from a syringe. A team in Italy who developed an innovative nicotine self-administration animal model for pharmacological treatments aimed at smoking cessation. It resulted in a 40-50 per cent reduction in the number of animals needed per study
Number of animals In 2008 the absolute number of animals used in our laboratories was nine per cent lower than in 1994 while R&D activity has tripled in the same period. We estimate that the proportion of total GSK animal research conducted by external contractors was lower in 2008 at 6.2 per cent, compared to 7.9 per cent in 2007. Animals used by GSK in 2008 (per cent)* Mice
71.1
Rats
20.5
Guinea pigs
7.1
Other rodents
0.2
Rabbits
0.4
Others
0.7
*This does not include animals used by external contractors on our behalf. Of the animals used by external contractors on our behalf in 2008, 88.7% were rodents and rabbits. Change in R&D activity compared to change in number of animals used by GSK*
* These data do not include animal research conducted by external contractors on our behalf. R&D activity combines our R&D budget and our vaccine sales, the two main drivers of animal use. We started separately estimating our external animal use in 2002 and to 2008 have recorded external animal use as representing 3.2%, 4.3%, 6.7%, 6.3%, 8.2%, 7.9% and 6.2% of total animal use. The range of external interactions that may involve GSK, directly or indirectly, in animal use is so diverse, and is reported to the regulators by third parties, that we refer to these data as an estimate.
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AAALACi accreditation Our animal laboratories in Belgium, Italy, Spain, the UK and the vast majority of those in the US are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALACi), a private, non-profit organisation that promotes the humane treatment of animals in science through voluntary accreditation and assessment programmes. To achieve AAALACi accreditation, an organisation must go through a rigorous assessment by the association which reviews facilities, workers and animal care. To maintain accreditation annual updates and on-site reviews on a tri-annual basis are required. These site visits are conducted by members of the AAALAC Council and other trained professional staff. This accreditation covers over 90 per cent of the animals housed in GSK-owned laboratories and we are working to extend this accreditation to our other animal facilities.
Our plans GSK is committed to the 3Rs; a current initiative includes a review of animal models across the business. This will look at the types of studies being performed to ensure the most suitable model is being used and that the appropriate numbers of animals are involved. Our R&D leadership team will review outcomes of this analysis and make recommendations for further initiatives in 2009 and beyond.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Human tissue research
Corporate Responsibility Report 2008 Human tissue research Research using human tissue or human biological samples is fundamental to the discovery, development and safety monitoring of GSK medicines. It is vital that this research is conducted in a manner that respects the rights of research participants and meets legal and ethical obligations. The UK Human Tissue Act 2004 makes consent the fundamental legal requirement for the collection, use and storage of human tissue in the UK. This was introduced in 2004 following events at Alder Hey Hospital and Bristol Royal Infirmary where human tissue was taken, used and stored without consent. In 2008, we introduced a policy which applies the principles of the UK Human Tissue Act on a global basis for research conducted, sponsored, supported or funded by GSK. This will ensure that the stringent ethical requirements of the UK law are applied wherever research is conducted using human biological samples.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Medical governance
Corporate Responsibility Report 2008 Medical governance GSK is committed to the highest standards of ethical medical practice. This supports our mission to improve the quality of human life by enabling people to do more, feel better and live longer. Medical governance at GSK is the system of principles, policies and accountabilities that ensures we apply generally recognised principles of good medical science, medical integrity, ethics and standards. It provides a framework to embed the following principles: Patient safety is the fundamental operating principle for GSK ahead of commercial or other interests Our clinical research is conducted in an objective, scientific and ethical manner which protects and informs patients Promotional practices and the information we provide on our products is ethical, accurate and balanced so that our medicines are used appropriately to benefit and minimise the risks for patientss Medical governance across GSK encompasses the principles, policies and accountabilities of three areas:
We have a framework for medical governance across all our businesses and our Chief Medical Officer (the most senior physician at GSK) has responsibility and authority for establishing an effective medical governance system. Our Corporate Executive Team members are responsible for the performance of, and compliance with this system within their areas of responsibility. Our Medical Governance Executive Committee establishes policy for medical governance, subject to approval from the Corporate Executive Team. It also ensures that our medical governance systems are operating effectively. Regional medical directors together with their regional presidents and the country/territory medical directors, ensure our policies and systems for medical governance are understood and complied with in the countries for which they have responsibility. Read about our patient safety governance framework.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Clinical research
Corporate Responsibility Report 2008 Clinical research We carry out a series of clinical trials to evaluate investigational medicines for their potential to become new medicines. The effect of the potential medicine will often be compared against marketed medicines or in some cases an inactive substance (a placebo). Successful clinical trial programmes usually have three or four phases, and safety is evaluated throughout the clinical trials process. We have rigorous procedures and assurance processes to ensure our clinical trials of our medicines are conducted according to the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonisation (ICH) and the principles contained in the World Medical Association Declaration of Helsinki on the µEthical Principles for Medical Research Involving Human Subjects (2008)¶. GSK-sponsored clinical trials are conducted to the same ethical standards irrespective of whether they take place in developed or developing countries. The safety of those who participate in our clinical trials is of paramount importance. Our informed consent procedure ensures that all volunteers are informed of aspects of the trial that are relevant to their decision to participate. All GSK employees involved in conducting trials receive training on regulatory requirements and GSK policies and trials are subject to audit by our internal audit department and regulators.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Clinical research Planning and approval
Corporate Responsibility Report 2008 Planning and approval A protocol is developed for each clinical trial. Protocols set out the purpose of the research and explain how the trial will be conducted and the results analysed ± including details of the dosage and duration of treatment and the number of participants required. The protocol also defines the measurements that will be used to evaluate the safety and efficacy of the medicine, and appropriate procedures should participants wish to withdraw from the study. Trial protocols are reviewed by government regulatory agencies in relevant countries when required. Protocols are reviewed by an independent ethical review committee of lay people, medical professionals and scientists. This committee also reviews and approves the information to be provided in the process of seeking informed consent. Ethics committees have the power to reject or stop a clinical trial.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Clinical research Informed consent
Corporate Responsibility Report 2008 Informed consent Informed consent means that a potential clinical trial participant voluntarily confirms their willingness to participate after being informed of aspects of the trial that are relevant to their decision to participate. It is documented by means of a written, signed and dated informed consent form. Informed consent for a clinical trial involves more than just reading and signing a consent form. There are two essential elements; a process to communicate the information and answer any questions, and signed documentation. The informed consent information is written and communicated in a non-technical style so that a lay person can understand it. It includes a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation and provisions for data protection) and explains participants' rights (including voluntary participation and the right to end participation). Researchers and health professionals know that a written document alone may not ensure that someone understands what participation means. Therefore, the research team discusses with the person the trial's purpose, procedures, risks and potential benefits, and the participants' rights. If the person decides to participate, the team will continue to update them on any new information that may affect their willingness to continue in the trial. Before, during and even after the trial, the person is given opportunities to ask questions and raise concerns. Thus, informed consent is an ongoing and interactive process. There may be special cases where obtaining someone¶s informed consent is not possible such as emergency research scenarios, or when children are below the age of legal consent. In these circumstances consent is sought from someone who is allowed to provide it under local laws and regulations. In situations when someone cannot read but is able to speak and understand the local language, an impartial witness is present during the informed consent process to confirm in writing that the information in the informed consent form was accurately explained and that the potential participant was able to ask questions and gave consent voluntarily.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Clinical research Post-trial treatment
Corporate Responsibility Report 2008 Post-trial treatment In general, we are not responsible for the funding of nationally licensed medicines after a trial, because this is the responsibility of governments and other providers as part of national healthcare systems. However, before beginning trials in diseases or conditions that will continue after the completion of the trial we must be assured that the healthcare system is able to provide, and will take responsibility for, the continued care of patients. In exceptional circumstances nationally licensed medicines may be funded by GSK after the trial so that they can be made available to trial participants who derived a measurable medical benefit. We will continue to fund the medicine until it is funded through the normal healthcare infrastructure or the patient no longer derives a medical benefit. There may be circumstances when there is a compelling medical rationale for patients to continue to receive an investigational medicine after the clinical trial. In this case, post-trial treatment may be provided in a clinical trial or through expanded access programmes which enable appropriate oversight and reporting of adverse events. In these circumstances, GSK will fund the investigational medicine for as long as the patient benefits from it or until the compound is approved and licensed in that country. Read more in our public policy on Clinical trials in the developing world
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Clinical research Clinical trials in the developing world
Corporate Responsibility Report 2008 Clinical trials in the developing world All GSK clinical trials, wherever they are carried out, are conducted to the same high standard. GSK does not conduct clinical trials in countries when we know at the outset that there is no intent to pursue registration and make the product available for use in that country. Additional steps may be needed to ensure that trials in some of the least developed countries are conducted according to the Good Clinical Practice (GCP) guidelines. For example, matching the objectives of informed consent to local culture may be necessary, for instance by involving local leaders and/or family members. In some circumstances capacity may be provided to help develop a certain skill or competence, or for general upgrading of performance ability, which will facilitate the prospective conduct of clinical research activity not only for GSK but also the broader community. Read more about post-trial treatment. Read our position statement on clinical trials in the developing world.
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Home Responsibility Research practices Public disclosure of clinical research
Corporate Responsibility Report 2008 Public disclosure of clinical research Approach
Performance and plans
Pharmaceutical companies are legally required to disclose all relevant data from clinical trials to the appropriate regulatory authorities when seeking approval for a new medicine. After approval, sponsors have a continuing obligation to provide regulatory authorities with updated safety information from clinical trials. Read more about patient safety Safety and efficacy information is provided to doctors through prescribing information which is approved by regulators. Public disclosure of our research is fundamental to advancing medical science and informing prescribers and patients about scientific findings relating to our medicines. Our Clinical Trial Register was launched in 2004 and is designed to supplement prescribing information and publications in the scientific literature. It contains data relating to marketed medicines and serves as a resource for researchers, medical professionals and the public to use alongside locally approved prescribing information. An improved Clinical Study Register, launched in 2008, has replaced the previous Register and now also includes protocol summaries and enhanced searching capabilities. Read a case study on how the new register is helping to improve access to clinical trials information. Read our position statement on disclosure of clinical trial information
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Home Responsibility Research practices Public disclosure of clinical research
Corporate Responsibility Report 2008 Public disclosure of clinical research Approach
Performance and plans
At the end of 2008 there were protocol summaries of all GSK actively recruiting clinical trials on ClinicalTrials.gov, 180 in total. This is a registry of clinical trials conducted around the world and provides information about a trial's purpose, who may participate, locations and contact details for more information. At the end of 2008 there were 3,273 clinical trial summaries on our Clinical Study Register. This includes clinical trials of our major marketed products which have been completed since the formation of GSK in 2000, or that were completed before this and are likely to inform medical judgement. Our objective is to disclose the trial results summaries for all new products on our Register within 12 months of the product reaching the market. We aim to disclose the results of trials completed after a product is approved for marketing within one year of trial completion. We met this objective in 2008. Update August 2009
An internal audit has subsequently shown that during 2008 the results of a small number of trials were not posted to the Register within 12 months of the product reaching the market. Following the audit the results of these studies were posted to the Register in July :HDUHLPSURYLQJRXUSURFHGXUHV for collecting and posting of trial results and expect to meet the objective for 2009 In 2008, a new Clinical Study Register replaced the previous Register and now also provides protocol summaries and enhanced search capabilities to users. Number of summaries of GSK clinical trials on the GSK Clinical Study Register (cumulative total)
Important steps to build on GSK¶s commitment to the transparency of our clinical research were taken in 2008. We have committed from January 2009 to: Posting information about other types of GSK¶s clinical research that evaluates our medicines on the GSK Clinical Study Register. We are adding GSK¶s observational research, meta-analyses and studies of terminated compounds to our current commitment of posting information related to all our clinical trials (phase l-lV) of marketed medicines. In addition we are adding the names of investigators who participate in
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our clinical research Ensuring that all our clinical research is either published as manuscripts in peer reviewed journals or, when studies are not published, providing context and interpretation via the GSK Clinical Study Register to supplement the result summary which is posted This will ensure our studies are made publicly available irrespective of whether the results are perceived to be positive or negative for our medicines. Our progress in meeting this commitment can be monitored by external audiences, as the GSK Clinical Study Register will include protocols or plans for our research as studies are initiated, and summaries of the results and references to publications following completion.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Patient safety
Corporate Responsibility Report 2008 Patient safety Ensuring the safety of our medicines and medical devices is critically important for the health and wellbeing of patients and the success of our business. All medicines have potential risks as well as benefits, although not everyone who takes a medicine will experience side effects. It is important that we identify, evaluate and minimise safety concerns to ensure that the overall benefits of a medicine outweigh any risks. We strive to serve patient interest by promptly detecting potential safety issues with our products and communicating with regulators so that appropriate decisions can be made and actions taken. Product safety is assessed in clinical trials before a product can be approved for marketing. Sometimes adverse events (potential safety issues) occur after approval when a product is being used by large numbers of patients. We have policies and a governance framework in place to help us detect and act on any adverse events. We have a dedicated team of scientists and healthcare professionals across the world which monitors and communicates safety issues to regulatory authorities. We are also investing in genetic research to help predict how individual patients respond to a medicine. In the future this will help healthcare providers prescribe safer and more effective medicines. Read about our patient safety governance framework and how we collect and report safety data.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Patient safety Patient safety governance framework
Corporate Responsibility Report 2008 Patient safety governance framework We have a Global Safety Board (GSB) which makes decisions on product safety issues. The Board is led by the Chief Medical Officer and composed of senior physicians and scientists. Its role is to: Oversee the safety of all investigational and marketed medicines Approve the first administration of investigational medicines to humans Define the doses and duration of treatments that are considered safe Approve the progression of investigational medicines into pivotal trials (these are trials which provide the primary data on which regulatory approval is based) Assess any issues related to patient safety that arise during product development or marketing Three of our central departments are responsible for recording, investigating and evaluating adverse events and reporting them to the relevant regulatory authorities, for example the US Food and Drug Administration (FDA) or the European Medicines Evaluation Agency (EMEA): Global Clinical Safety and Pharmacovigilance team (GCSP), part of GSK Research & Development, responsible for the safety evaluation of all our pharmaceuticals and devices GSK Biologicals Clinical Safety and Pharmacovigilance department, part of our vaccines business, responsible for the safety evaluation of GSK vaccines Consumer Healthcare Product Safety group, part of our consumer healthcare business, responsible for the safety evaluation of consumer healthcare products We require that all GSK staff immediately report any issues relating to the safety or quality of our medicines. Read more about our expectations in our Employee Guide for Business Conduct. Read about our medical governance. Benefit-risk management
We assess the balance between the benefits and risks of a particular medicine throughout its lifecycle ± from early development, during clinical trials, and once the product is on the market. We evaluate and document all available safety information to build a detailed benefit-risk profile of each product. We use this information to develop a benefit-risk management plan, which identifies ways to improve a product¶s benefits and minimise any risks. We review and update plans regularly during clinical development and for a period after a product is approved for marketing.
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Home Responsibility Research practices Patient safety Collecting and reporting safety data
Corporate Responsibility Report 2008 Collecting and reporting safety data We receive information on adverse events from several sources, including: Unsolicited reports from health professionals and patients Post-marketing trials or observational studies Investigators who submit clinical study reports Regulatory authorities Medical and scientific literature Newspapers and other media Each GSK employee is responsible for reporting any adverse event they become aware of. Any adverse events that occur are recorded on our global safety database and clinical trial database and are investigated by our clinical and pharmacovigilance teams. We report potential safety issues to regulatory authorities on a regular basis. Each country manager is responsible for ensuring the collection of safety information and reporting this to the relevant central safety department and to the local regulatory authority. During 2008, as part of our 2008 Management Certification process, over 14,000 managers acknowledged their compliance with our policy on Adverse Event Reporting which specifies that each GSK employee is responsible for reporting any adverse event they become aware of during the conduct of their work. We have added an Adverse Event Reporting button to the front page of myGSK, our intranet site, to make it easier for employees to report any adverse event they may learn about. Regulators in some countries are also publishing information on adverse events on the internet. For example, data for products marketed in the UK are available via the Medicines and Healthcare products Regulatory Agency. Some safety data are also available in Canada, while in the US the Food and Drug Administration has made the information in its database more accessible to the public by publishing a quarterly report of potential safety issues that it is investigating further. In 2008, research on our diabetes product Avandia continued and a new, FDA required, cardiovascular outcome study was designed and will be initiated in 2009. There was also a combined FDA Advisory Committee review of respiratory products containing long-acting beta2 agonists. Read more on the questions raised about Avandia. Read more on questions about the safety of our products containing long-acting beta2 agonists. Read about our medical governance. Read our position statement on Pharmacovigilance Responding to adverse events
Adverse events affect the benefit-risk profile of a product and corrective actions may be needed to minimise the risk. This can include carrying out further clinical trials, modifying the prescribing information, communications to physicians and other healthcare providers or establishing specific methods to minimise risk. Some products are subject to limited distribution programmes, for prescription
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
by specialist doctors only. In certain cases it may be appropriate to stop a clinical trial or withdraw a product from the market. Our global labelling committees review and approve the prescribing information for all our products and ensure this is updated when appropriate.
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Home Responsibility Research practices Patient safety Collecting and reporting safety data Responding to questions about Avandia
Corporate Responsibility Report 2008 Responding to questions about Avandia Avandia is our leading treatment for type 2 diabetes. In 2007, a meta-analysis published in the New England Journal of Medicine 1 and GSK¶s own meta-analysis 2 (submitted to the FDA and other regulators in 2006) were at the centre of a debate on whether Avandia may be associated with an increased risk of myocardial infarction and death from cardiovascular causes. Following an FDA Advisory Committee meeting, the FDA approved updated prescribing information for Avandia, including new text in the existing boxed warning, in November 2007. This updated prescribing information summarised data from an FDA meta-analysis of myocardial ischemic events that suggested a risk associated with Avandia, and from three long-term clinical trials 3 comparing Avandia against both placebo and other oral anti-diabetes medicines that did not confirm or exclude the risk. This revised prescribing information included that µin their entirety, the available data on the risk of myocardial ischemia are inconclusive¶. In 2008, research involving Avandia continued, including the cardiovascular outcome study called RECORD, for which results will be available in 2009. In addition, GSK worked to design an FDA-required cardiovascular outcome study of Avandia, to be called the TIDE study, to begin in 2009. Update August 2009
Results of the cardiovascular outcome study RECORD wereSXEOLVKHGLQ-XQH 5(&25'ZDVD large, prospective, randomized, controlled study that was initiated in 2001, and designed to compare cardiovascular outcomes of patients on Avandia added to metformin or sulfonylurea to those on metformin and sulfonylurea. The study showed that the combined endpoint of cardiovascular hospitalization or cardiovascular death (which includes heart attack, congestive heart failure and stroke) was not statistically different between the two groups after an average of 5.5 years of therapy. 4 The TIDE study has started in 2009 as planned. All medicines, Avandia included, carry risks as well as benefits. Because type 2 diabetes is chronic, relentlessly progressive and a life-threatening disease, and because physicians often need to prescribe two or three medicines to help their patients maintain their blood sugar levels, having an array of treatment options is important. GSK believes it is important that Avandia is available to support effective treatment of type 2 diabetes. 1. S. Nissen & K. Wolski, Effect of Rosiglitazone on the Risk or Myocardial Infarction and Death from Cardiovascular Causes, N. Engl. J. Med. 2007; 356: 2457-71 2. A. Cobitz, et al, A retrospective evaluation of congestive heart failure and myocardial ischemia events in 14237 patients with type 2 diabetes mellitus enrolled in 42 short-term, double-blind, randomized clinical studies with rosiglitazone, Pharmacoepidemiology and Drug Safety, 2008; 17: 769±781 3. i) P. Home, et al, Rosiglitazone Evaluated for Cardiovascular Outcomes - An Interim Analysis, N. Engl. J. Med. 2007; 357: 28-38; ii) S. Kahn, et al, Glycemic Durability of Rosiglitazone, Metformin, or Glyburide Monotherapy, N. Engl. J. Med. 2006; 355: 2427-43; iii) The DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators, Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial, Lancet, 2006; 368: 1096-105.]
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3+RPHHWDO5RVLJOLWD]RQH(YDOXDWHGIRU Cardiovascular Outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial, Lancet, 2009, 373: 2125-2135.
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Home Responsibility Research practices Patient safety Collecting and reporting safety data Questions about the safety of our products containing long acting beta2 agonists
Corporate Responsibility Report 2008 Questions about the safety of our products containing long-acting beta2 agonists Long-acting beta2 agonists, known as LABAs, are daily controller medicines that relieve and help prevent airway constriction. Airway constriction is one of the two main components of asthma. LABAs do not treat the other main component of asthma ± inflammation. This can be treated by another type of daily controller medicine called an inhaled corticosteroid (ICS). LABAs, including GSK¶s product Serevent, should not be used alone in the treatment of persistent asthma. Leading treatment guidelines recommend that LABAs be used for appropriate patients with asthma only in combination with an ICS. GSK makes two products containing the LABA salmeterol. Seretide/Advair is a combination of salmeterol and the ICS fluticasone, while Serevent contains salmeterol alone. In December 2008 a combined Advisory Committee to the US Food and Drug Administration reviewed the benefit-risk profile of medicines containing LABAs in children and adults with asthma. This review included all LABA-containing products indicated for use in treating asthma, not just GSK¶s products, and addressed lingering concerns that LABAs may increase the risk of asthma-related death, as current product labels prominently warn. The Advisory Committee makes recommendations to the FDA, which then makes the final decision on any actions required. For Seretide/Advair, the Committee unanimously voted that the benefits of Seretide/Advair outweigh the risks for patients 18 years and older. The Committee also voted in favour of a positive benefit-risk profile in younger patients, although the individual votes were mixed. For Serevent, the Committee found that the benefits do not outweigh the risks for the treatment of asthma. Concerns were expressed about the potential for Serevent to be used alone in the treatment of asthma, contrary to the current prescribing information, in a way that would make the benefit-risk profile unfavourable. In contrast, Seretide/Advair is a combination therapy of a LABA and an ICS, so combination use is assured. Although GSK acknowledges concerns that use of Serevent without an ICS is not in the best interests of asthma patients, we favour the option of allowing dual therapy using separate inhalers. Use of separate inhalers is an important treatment option for asthma patients who need an alternative ICS to fluticasone (the ICS contained in Seretide/Advair), or the flexibility of ICS doses beyond those available in a combination product. It is also important for asthma patients who receive more favourable reimbursement for separate inhalers. GSK believes that with appropriate labelling and proactive communication of the risks of using a LABA alone, the potential for misuse of Serevent as monotherapy can be acceptably reduced so that dual therapy using separate inhalers remains available for asthma patients who need it. In September 2008, before the Advisory Committee meeting, GSK submitted a proposed label change to the FDA for Serevent to clarify that use in asthma patients must be in combination with ICS, in line with prescribing information in all countries in which Serevent is marketed. We are awaiting the outcome of the FDA¶s consideration of GSK¶s proposed label change, and of the Advisory Committee¶s review. We will actively cooperate with the agency in reaching an appropriate resolution in the best interests of asthma patients.
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Home Responsibility Research practices Patient safety Performance
Corporate Responsibility Report 2008 Performance We have continued to improve our patient safety systems, safety databases and monitoring processes. Examples from 2008 include: Established two more Clinical Toxicities Strategy Panels (comprising internal and external experts) to provide expert safety input throughout the medicine development process. We now have expert panels in four areas: cardiovascular, hepatic, renal and haematological Implemented a clinical trials signal detection (CTSD) tool for review of completed study data, in partnership with Lincoln Technologies. This has enhanced our ability to identify and explore safety signals in our clinical trials. The system won a BIO IT award Launched a prototype for our Molecular Clinical Safety Programme (MCSP). MCSP is a tool that seeks to better inform decision-making in medicine development by integrating chemistry, pre-clinical and human safety data and enabling us to look for patterns across the different types of safety information. In October 2008 the GSK team won the Wall Street Journal Technology Innovation Award for Healthcare IT for developing this system. The entry was selected by an independent panel of judges, who reviewed more than 700 applications for the awards
Working with others We work with government officials, industry partners and policy makers in efforts to build an enhanced safety system. For example GSK is the industry lead in the benefit-risk project consortium of the European Commission¶s public-private partnership, the Innovative Medicines Initiative, which aims to develop methodologies to enhance the assessment of the benefit-risk profile of new medicines. GSK is a key partner among the US Food and Drug Administration, other pharmaceutical companies and academia in the US to explore the development of a new system for the detection of adverse events and benefits of medicines using large healthcare system databases. Read about our collaborative research on emerging technologies.
Serious Adverse Events Consortium In 2007, we co-founded the Serious Adverse Events Consortium (SAEC), a collaboration involving more than 20 partners. The SAEC is working to improve patient safety by identifying genetic variants that predict adverse events such as drug-induced liver injury and a rare but serious severe skin rash called Stevens Johnson Syndrome. GSK scientists co-chair the SAEC scientific management committee and have a seat on the board of directors.
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Home Responsibility Research practices Maintaining the confidentiality of research participants
Corporate Responsibility Report 2008 Maintaining the confidentiality of research participants It is vital that medical information collected during research is protected to maintain the confidentiality of participants. We have rigorous procedures to control the use of research data. Our research activities are conducted according to fundamental ethical and legal principles, including consent and ethics committee approval. We use a variety of procedures to protect the confidentiality of research participants¶ data, including data coding, data encryption and restricted access to research databases. Third parties handling research data on our behalf are required to comply with relevant data protection legislation and standards. We only collect information about individuals that is relevant to the research study. This includes medical information such as health status, medical conditions (including, on occasions, genetic data), treatment of conditions and ethnic origin. This means that, in the vast majority of instances, we do not collect or store information that can directly identify individuals such as initials, names, addresses or personal ID numbers. Information that can identify individuals is only used in very specific instances required by law and regulations such as safety monitoring and pharmacovigilance. We retain medical research data using the minimum amount of identifying information and only for the duration reasonably necessary to meet regulatory, legal or research needs.
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Home Responsibility Research practices Working with healthcare professionals
Corporate Responsibility Report 2008 Working with healthcare professionals Our policies governing interactions between GSK R&D staff and healthcare practitioners require that:
All clinical trial investigators must be selected solely on their qualifications to conduct good quality clinical research. Their history of using or not using GSK products must not be taken into account when deciding whether to include or exclude them in a particular trial
Payments to practitioners are governed by contracts and any compensation reflects fair market value for the work performed
No payments are offered or made to influence their judgement on whether to enrol or maintain a participant in a clinical study
Gifts to healthcare professionals involved in research projects for GSK are not permitted.
From 2009, the PhRMA Code on Interactions with Healthcare Professionals also prohibits non-educational gifts to healthcare professionals involved in research. GSK policies have prohibited these gifts to healthcare professionals involved in research since 2006. We are also committing to disclose research payments made to healthcare professionals and institutions. This will start with payments to US healthcare professionals and institutions for conduct of clinical trials starting in 2010. Thereafter it will be extended to payments for other types of research and to healthcare professionals and institutions outside the US. Read more about our policies and monitoring systems that govern our relationships with healthcare professionals.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Training and auditing
Corporate Responsibility Report 2008 Training and auditing Approach
Performance
Training for clinical trials All employees involved in designing, conducting, recording and reporting GSK-sponsored clinical research studies are trained in the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonisation (ICH). Employees must have completed the required training before undertaking these roles. We keep detailed training records which are routinely requested by regulatory authorities when undertaking an inspection of GSK clinical research trials.
Auditing for clinical trials GSK¶s internal audit department audits the conduct of clinical trials. Audits cover GSK systems and processes, as well as external clinical research organisations and investigators performing clinical research on our behalf. Trials are selected for audit based on risk. Risk factors include the complexity of the study, the patient population, the location of the study, previous audit history and any unusual findings during the conduct of the study. Results are reported quarterly to the R&D Compliance Board, and annually to the Risk Oversight and Compliance Council and the Audit Committee of GSK¶s Board of Directors. Read more about these in the corporate governance section of our Annual Report. Members of our Global Safety Board (GSB) receive individual audit reports on any safety-related findings. Any concerns or issues identified are fully investigated and appropriate corrective action taken. For GSK staff corrective actions may include development of new training programmes or retraining for the individuals concerned. In more severe cases appropriate disciplinary action will be taken, up to and including dismissal. For external investigators, GSK may retrain the investigator, or stop working with the investigator. Trial data from noncompliant investigative sites is excluded from the analysis. Regulatory authorities also carry out inspections of GSK and the investigators we use to conduct clinical trials.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Training and auditing
Corporate Responsibility Report 2008 Training and auditing Approach
Performance
Training for clinical trials In 2008 there were 66,579 training activities related to Good Clinical Practice (GCP). Each µtraining activity¶ represents a successful completion of an e-learning module or instructor-led course related to GCP by one of our employees or contractors.
Auditing for clinical trials In 2008 we conducted 208 audits. These included: 150 audits of investigator sites conducting GSK-sponsored trials. This represents approximately five per cent of investigator sites participating in pivotal clinical trials 16 audits of internal GSK systems and processes used in managing clinical trials and data 30 audits of clinical research organisations carrying out clinical trials on GSK¶s behalf 12 audits of GSK local operating companies involved in clinical research activities. WIn addition, 24 investigations were conducted in response to suspected irregularities at investigator sites. Issues identified at investigator sites included insufficient oversight of clinical trial activities by investigators. Oversight covers all areas of investigator responsibility including: knowledge of the protocol design; appropriate and documented delegation of tasks to skilled personnel; and availability to meet sponsor representatives at regular intervals during the study. Additional training for investigators and implementation of further internal controls are helping to reduce the frequency and significance of this issue. Inspections of investigators, clinical research organisations, independent ethics committees/Institutional Review Boards and sponsors of clinical trials are also carried out by regulatory authorities to ensure the safety of trial participants, the quality of data and that trials are conducted according to Good Clinical Practice. During 2008 there were more than 40 such inspections of GSK and investigators used by GSK to conduct clinical trials. The Food and Drug Administration (FDA) conducted a routine Post Marketing Adverse Drug Experience Inspection in 2007. The inspection involved a review of GSK¶s processes for receiving, capturing and tracking adverse drug experience information for GSK products, as well as reporting these data to the FDA. In the course of the inspection, the inspector focused on GSK¶s compliance with regulatory requirements for New Drug Application (NDA) Annual Reports and periodic adverse drug experience reports. As a result of the inspection GSK received a warning letter from the agency in March 2008. The FDA determined that for some products, certain required reports submitted by GSK had not included all required information about clinical studies on a timely basis. The FDA letter acknowledges that information not captured in the periodic reports was, in many cases, submitted to the Agency in other reports and communications. In addition, information about the start of clinical trials that was omitted from some reports was available at www.clinicaltrials.gov. Clinical trial results also are posted publicly to GSK¶s Clinical Study Register. We acknowledge the seriousness of the issues raised in the warning letter, and corrective steps have been taken or are underway to make sure periodic reports are filed completely and promptly. After the inspection, GSK initiated a review of all applicable processes and reporting systems. We have made and will continue progress in updating procedures and improving compliance in the area of reporting, including additional
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
training to ensure that all procedures are followed across all product lines. GSK works continuously to monitor and, as necessary, enhance its compliance systems and procedures.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Case studies
Corporate Responsibility Report 2008 Case studies Focus on the Patient programme Our Focus on the Patient programme helps our R&D employees understand patient needs and inspires them to do more to help improve the lives of patients. In 2008 we held 12 seminars where patients visited GSK sites to help our R&D employees understand the realities of living with their illness. The seminars included discussions on breast cancer, cystic fibrosis, HIV/AIDS, inflammatory bowel disease, schizophrenia, epilepsy, meningitis, hepatitis C, pulmonary hypertension, idiopathic pulmonary fibrosis and migraine headaches. There were over 4,640 attendees at these seminars. We have also held lunchtime sessions to develop ideas and actions. One session prompted the organisation of a seminar at our site in Verona, Italy, providing insight for local scientists developing medicines for sleep disorders and depression. Another idea led to µPatient Empowered¶, a project to improve patients¶ experience in GSK clinical trials, through patient-focused study design and simplified patient-directed communications. To inform our employees about the patients they are helping through their work in R&D, regular monthly bulletins highlight key medicines in our pipeline and how they will meet the needs of patients. This helps to motivate employees by reminding them about the importance of their work. A survey of R&D employees showed over 50% of respondents felt that there was an increase in patient focus across the businesses through greater application of patient focus in work processes and the development of medicines.
Clinical Study Register It is important that the results of all studies that evaluate medicines are in the public domain. This enables the information to be used to help inform medical judgement and advance medical science. Traditionally, publication in scientific and medical journals has been sought but there are well recognised limitations: Have all studies been published by researchers? What if it is not possible to publish a study in a peer reviewed journal? Posting a summary of each study on the internet when it is initiated enables all studies to be tracked to publication. Studies that are not publicly disclosed can be identified and researchers called to account. Posting the results after the study is completed means that results are in the public domain, whether or not the study is accepted for publication. GSK provides an online Clinical Study Register, which now contains the results of over 3,000 trials, covering over 100 GSK products dating back to 2000 when the company was formed. Launched in 2004, we are pleased that the site has been a success and our latest figures show that the site is receiving over 25,000 visitors a month. In 2008 we took further steps to build on our commitment to the transparency of clinical research: To help people quickly find the information they need, we launched a revised version of the Clinical Study Register, which includes an improved user interface making it easier for users to find information by disease area or medicine We are adding observational research and meta-analyses that evaluate our medicines and studies of
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
terminated compounds to the Register. This adds to our current commitment to post-protocol summaries and summary results of all GSK¶s clinical trials (phases l-lV) for our marketed medicines However, the disclosure of research protocols and results online should be seen as a supplement and not a replacement for the need to publish studies in peer reviewed journals. We believe that the level of public disclosure achieved through posting results on our Register alone is below that achieved through papers published in peer reviewed journals which more fully explain a study and places the results in context. GSK aims to publish our clinical research of our medicines as more comprehensive papers in peer reviewed journals. When studies are not published we will provide context and interpretation via our register.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Research practices Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders. How are you assured that the risks for healthy volunteers who take experimental medicines for the first time are minimised? Before a clinical trial can take place, a new compound must undergo a series of stringent laboratory tests. These tests involve the use of animals and human tissue to predict the effects of an investigational medicine in the human body, including any potential side effects. On the basis of the predictions we establish dosing levels with a sufficient margin of safety and/or appropriate monitoring procedures. The µpre-clinical¶ data from laboratory tests, and our proposal for the design of each µfirst time in human¶ clinical trial, are reviewed by a GSK committee, known as the Global Safety Board, of experienced senior physicians and other experts who are independent of the project team. Regulatory authorities and independent ethics committees must approve the trial before it can go ahead. Clinical trials are designed to minimise risk. For example, we initially give volunteers a very low dose of the investigational medicine and increase dosing gradually, carefully sequenced among subgroups, to be cautious in our approach. Trials of an investigational medicine being tested in humans for the first time are conducted in clinical units with rapid access to hospital emergency care. All clinical trial volunteers are provided with information about the study, including potential risks, and have the opportunity to discuss these risks with researchers before deciding whether or not to participate. This is known as informed consent. You plan to enter in to more research collaborations. How will you ensure that the organisations you partner with meet your research and animal welfare standards? We recognise that working in collaboration with other organisations brings certain risks. We are developing routine safeguards to ensure our partners work according to the same core principles as GSK, including those that govern our use of animals in research. These checks will be applied when we are evaluating whether to enter into collaboration, and subsequently on an ongoing basis within the framework established to govern a collaboration, typically a Joint Steering Committee. GSK¶s willingness to enter or continue a collaboration depends on having adequate assurance of a shared commitment to core principles. GSK is opening an R&D facility in China. Will this affect your research standards? Is it a cost reduction exercise? We have opened a new R&D facility in China which is focusing on R&D into neurodegenerative disorders, for which better therapies are desperately needed: Alzheimer¶s disease, Parkinson¶s disease and multiple sclerosis. The costs of conducting research in China are currently relativity lower than those in other markets. However, lower costs are not the reason behind the decision to set up this new facility. The new centre enables us to benefit from accessing the vast talent pool and knowledge in life sciences in China, and to increase focus and depth in important disease areas. Our R&D in China is conducted in accordance with GSK¶s global quality and ethical standards. All R&D policies and monitoring procedures apply to our operations in China. We have committed significant regional and local resource to ensuring our operations in China comply with both Chinese government requirements and GSK¶s global standards.
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Home Responsibility Ethical conduct
Corporate Responsibility Report 2008 Ethical conduct We are committed to creating a strong ethical culture at GSK. We do this by putting the appropriate policies in place, recruiting the right people and equipping them with tools to make ethical decisions. Putting patients first is the core principle of being an ethical pharmaceutical company. Profit without principle is short lived. Failure to uphold high standards of ethical conduct carries significant business risk: Erosion of trust in GSK and our products including among regulators, doctors and patients Fines and litigation resulting in serious financial or legal consequences Damage to GSK¶s reputation Our Code of Conduct sets out fundamental standards for all employees. The Employee Guide to Business Conduct builds on the Code and explains what employees must do to meet its requirements. It provides guidance, including specific examples, on what constitutes unethical behaviour. Strong policies, codes of practice and good training are essential elements of our approach. However, on their own they cannot guarantee that our employees will meet our standards. Our internal compliance systems are designed to identify and address breaches of our codes. We fully investigate suspected breaches and take appropriate disciplinary action, including dismissal where appropriate. We have clear policies and procedures to prevent corrupt and anti-competitive behaviour. Maintaining high ethical standards in our marketing is also vital and is relevant to patient safety. It is essential that our marketing practices help doctors to prescribe medicines that are in the patient¶s best interests. Our policies prohibit kickbacks, bribery or other inducements to doctors, and any promotion for unapproved uses of our medicines. Maintaining high ethical standards during all stages of R&D and once a product is approved for marketing is a key part of our commitment to put the patient first. Your ethical compass
Our Employee Guide to Business Conduct includes an µethical compass¶ that helps employees deal with ethical issues that are difficult to resolve. When faced with such a situation, we encourage our people to ask themselves these questions: Is it legal and ethical? Is it consistent with GSK policy and the Code of Conduct? Is it consistent with GSK¶s Mission and Spirit? Can I explain it to my family and friends? Would I be comfortable if it appeared in a newspaper? We encourage employees to seek additional guidance and to keep asking questions until they are certain that they are making the right choice.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Ethical conduct Code of conduct and business ethics
Corporate Responsibility Report 2008 Code of Conduct and business ethics Code of Conduct The GSK Code of Conduct sets out the standards we expect from our employees and contractors. It contains the following key requirements: Conduct business with honesty and integrity and in a professional manner that protects GSK ¶s good public image and reputation Build relationships with customers, vendors, suppliers and fellow employees based on trust and treat each of these individuals with respect and dignity when conducting business Become familiar with and comply with legal requirements and GSK policy and procedures Avoid any activities that could involve or lead to involvement in any unlawful practice or harm to GSK¶s reputation or image Avoid actual or potential conflicts of interest with GSK, or the appearance thereof, in all transactions Read the full Code of Conduct. Our Employee Guide to Business Conduct builds on the Code and explains what employees must do to meet its requirements.
Business ethics Corrupt and anti-competitive behaviour undermines fair competition, inhibits economic development and is bad for economies, business and people. Our Employee Guide to Business Conduct contains the policies and guidance to ensure that we operate within the letter and spirit of the law and maintain high standards of ethical business behaviour. Anti-competitive behaviour We are committed to free and open competition. We succeed as a company because of the high quality and competitiveness of our products and the talent and commitment of our employees. Our policy on anti-competitive behaviour covers issues such as mergers, abuse of monopoly powers, resale price maintenance, predatory pricing and other restrictive agreements and practices. It sets out the standards of behaviour we expect from our employees and agents. Preventing corruption Our policy on anti-corruption forbids payments or inducements to political candidates, legislators, political parties and party officials, or government officials or employees, whether local or national, including officials and employees of government-owned enterprises and of public international organisations. We also have separate policies on political contributions or donations and on acceptance of gifts or entertainment by our employees. Sample questions from our Employee Guide to Business Conduct
Question: We have received an order for an unusual volume and combination of pharmaceuticals from a new customer in a location noted for political instability. The shipment location is in another country, and the customer has said we should not bother including the usual consumer use information. Is this a problem?
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Answer: There are enough red flags here that you need to get advice from the GSK Legal Department. The information you have indicates that this material might be shipped to a prohibited country or used for improper or even terrorist activity. You need to know your customer and get advice on what to do. Question: A vendor offers to sell a GSK product manager a mailing list of 10,000 names of individuals who are being treated for depression. Are there any concerns with the purchase of such a list? Answer: Yes. Many countries, including the US and those in the EU, have established strict laws protecting healthcare information that identifies an individual. Written authorisation by each individual is usually required for GSK to receive this information.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Ethical conduct Marketing ethics
Corporate Responsibility Report 2008 Marketing ethics We market our prescription medicines and vaccines to doctors, hospitals and governments. In some countries, such as the US, we also advertise medicines directly to consumers. Our specialist sales representatives meet regularly with doctors and pharmacists to inform them about our medicines and their approved uses. We believe that sales representatives play an important role in providing up-to-date information to doctors on our products and their benefits and risks to patients. However, we recognise that the marketing of pharmaceutical products raises some challenging issues. In particular, some people are concerned that marketing by pharmaceutical companies exerts undue influence on doctors, that sales representatives do not always give doctors full information about potential side-effects, or that promotion of unapproved uses of medicines may be occurring. Our regional marketing codes forbid these practices and other unethical conduct. We provide regular training so that our sales teams understand these codes and we conduct monitoring to assess compliance.
Marketing Codes of Practice The sale and promotion of pharmaceutical products is highly regulated by governments and medical agencies. We have developed marketing codes and policies and provide training for sales representatives to ensure that they understand how to behave ethically and comply with the law. In many countries our codes and policies go beyond legal requirements. Our products are sold in more than 150 countries around the world. The first priority with any product in any country is patient safety. We have systems and processes to collect, analyse and report safety concerns about our products. Our marketing codes of practice apply to all employees and agents. They commit us to promotional practices that are ethical, responsible, principled and patient-centred. They prohibit kickbacks, bribery or other inducements to doctors, and any promotion for unapproved uses of our medicines. These company policies are supported by regional marketing practices codes which apply the same standards but reflect differences in market structures, national healthcare systems and regulations. A new US PhRMA Code on interactions with healthcare professionals (HCPs) came into effect in January 2009 and we have fully aligned our sales and marketing practices to the requirements of the Code. In some cases, GSK has gone beyond the requirements of the Code, including phasing in a prohibition on giving non educational items in the US, and reinforcing a $150,000 cap on payments made to an individual US-based HCP working as a consultant to the company, for example by participating in an advisory board or speaking at GSK-sponsored meetings. Our updated Commercial Practice Policies (CPPs) will be available in the first quarter of 2009. GSK is initiating a review of all internal, regional codes relating to the sales and promotion of our pharmaceutical products. Through this review, we intend to align, where legally and culturally appropriate, GSK¶s regional codes. This alignment will lead GSK to develop more detailed global principles guiding the sales and marketing of GSK pharmaceutical products all over the world.
Helping to strengthen industry codes GSK supports efforts to strengthen marketing standards across the pharmaceutical industry. This benefits us by creating a µlevel playing field¶ in the countries in which we operate and helps to improve
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
the reputation of the pharmaceutical industry as a whole. In 2008, we took an active role in working with the US pharmaceutical industry association, PhRMA, to develop the changes to its Code on Interactions with Healthcare Professionals. GSK will certify compliance to the Code during the first quarter of 2009. The Code will guide the sale and marketing of GSK pharmaceutical products in the US. Our Marketing Codes of Practice in summary
Full and accurate information ± information can only be provided on approved uses for a medicine. It must be based on valid scientific evidence and must be accurate, balanced, fair, objective, unambiguous and up to date Promotional items to healthcare professionals ± branded promotional items must be given only occasionally and must be relevant to the practice of medicine. Their nominal value was no more than $10 or less than 6 in the UK in 2008. From 2009, we will no longer distribute non-educational items in the US, in line with the US PhRMA code. Items cannot be given as an inducement to prescribe any of our medicines or to medical professionals retained as consultants to GSK Appropriate hospitality for meetings ± no entertainment is permitted. Hospitality, such as travel costs or food, may only be provided for meetings with an educational or professional purpose. The level of hospitality must be appropriate to the occasion and must only be provided for relevant healthcare professionals, not spouses, children, office personnel or any other guests Decisions about grants for medical education are reviewed by qualified medical or scientific personnel
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Ethical conduct Marketing ethics Relationships with healthcare professionals
Corporate Responsibility Report 2008 Relationships with healthcare professionals Approach
Performance & plans
As well as our marketing codes we have detailed policies and monitoring systems governing our relationship with healthcare professionals in the following areas: Medical education programmes ± we provide funding to enable physicians, pharmacists, nurses and other healthcare professionals to attend education courses and conferences in therapeutic areas relevant to GSK. We do not consider this to be part of our marketing and our policies state that the content of the education programme or the choice of faculty should be independently approved Sponsoring speakers ± we provide sponsorship for healthcare professionals to attend conferences to present their research results or to speak on healthcare issues. Speakers must declare during their speech that they are funded by GSK Advisory services ± we engage with healthcare professionals to understand unmet medical needs and developments in science and treatments. This helps us to understand current and future markets for our products. This engagement may take the form of convening advisory panels or conducting broader market research Read how we engage with healthcare professionals who conduct medical research on our behalf. Our policies and processes vary by region to comply with local laws and industry practices. They meet or exceed the codes on relationships with healthcare professionals from the following industry organisations: The Pharmaceutical Research and Manufacturers of America (PhRMA) The European Federation of Pharmaceutical Industries and Associations (EFPIA) The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) The Japan Pharmaceuticals Manufacturers Association (JPMA) Our policies and processes are further restricted in the US where they include: A limit on payments to healthcare professionals through speaker and advisory fees of $150,000 a year for an individual physician. The majority of our US healthcare professional consultants receive fees that total less than $10,000 per year A state reporting system for expenditure with healthcare professionals, in line with legislation in several US states. This system can help us to investigate situations where excessive meals and gifts may have been provided by GSK A requirement that GSK funding of grants to any healthcare-related group, including patient advocacy groups and physician associations, cannot exceed 25 per cent of the group¶s annual income A speaker evaluation process covering healthcare professionals sponsored by GSK. This requires our regional medical scientists to evaluate high-frequency speakers, and to provide feedback to the healthcare professionals on their effectiveness and compliance with the GSK Speaker Programmes policy A process to monitor questions posed by doctors to our medical information department about off-label uses of our products, and the number and type of referrals made by individual representatives. This helps to ensure that representatives are not promoting off-label uses. All questions from doctors on off-label uses
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for our products must now be referred to our medical information department.
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Home Responsibility Ethical conduct Marketing ethics Relationships with healthcare professionals
Corporate Responsibility Report 2008 Relationships with healthcare professionals Approach
Performance & plans
United States We make payments to healthcare professionals for consultancy work such as participating on an advisory board or speaking at GSK-sponsored meetings. The majority of our US HCP consultants receive fees that total less than $10,000 per year. However, in 2009 we reinforced a cap on payments to HCPs in the US of $150,000 a year for an individual physician. It is in our interest that the physicians we work with do not receive excessive funding from GSK. This ensures that their work for GSK does not detract from the time they spend with patients or conducting research, which could reduce their professional credibility and their value to GSK as sources of current medical expertise.
Europe In 2008, we changed our European code of practice on interactions with healthcare professionals in response to a new Code of Promotion published by the European Federation of Pharmaceutical Industries and Associations. We made the following changes and refinements to our code: Use of consultants ± GSK employees responsible for selecting consultants must have the expertise to evaluate whether the consultant is suitable to meet the identified business need and is of real value to GSK. The consultant is required to declare the consultancy arrangements when speaking publicly on a related issue. Samples ± Product samples are now to be given only in limited numbers and for a limited time, by reference to local standards, for the purposes of familiarisation. This replaces previous limits that were less restrictive and did not specify a quantity or timeframe. Grants and donations ± We introduced a new policy on grants and financial donations to health organisations. We are not involved in how the grant or donation is used and receive no service in return. The new policy states that grants and donations: May only be given to a health organisation in response to an unsolicited request and only for the purposes of healthcare or research Must not be offered or given on the understanding that the recipient will prescribe or recommend our products Must be documented and published externally. To meet this requirement the amount of the grant and the recipient will be published on GSK¶s website from 2010 Are only permitted to health organisations rather than individuals Phase lV clinical studies ± These are studies conducted after a medicine has been approved for marketing. We clarified the principles behind these studies, clearly setting out the terms for GSK and collaborative studies: Studies must not be commissioned as an inducement to prescribe, supply or recommend medicines. They must have a clear scientific and/or educational purpose There must be a contract with the institution undertaking the research
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The trial protocol must be reviewed and approved by an ethical committee, where available GSK R&D or medical personnel must approve and supervise studies Results will be distributed to investigators
Asia Pacific, Japan and Emerging Markets GSK continues to be very active in the IFPMA Code Compliance Network and many of our senior country managers have been very supportive of leading industry change as part of strengthening local codes Nigeria GSK has received the µBest Compliant Company¶ award issued by NAFDAC (the regulatory authority). This award is the first of its kind and aims to encourage compliance among companies in Nigeria and to encourage Nigerians to buy from companies deemed to be compliant by NAFDAC. Australia From January 2009, GSK Australia has stopped distributing brand reminders to healthcare professionals, including pens and notepads, with the exception of new brand launches. This aligns our behaviour with community expectations of how we interact with customers.
Our plans We will publish grants and donations made in the US during 2009, and in Europe by 2010. In Australia, an initiative to move all States to the Victoria operating model will take effect from 1 August 2009, delivering improved control around samples accountability and security, and supporting our aim to achieve the highest levels of professional standards. The field sales force will no longer distribute samples directly to healthcare professionals. Instead, orders will be taken by our medical representatives and samples delivered direct to surgeries from our central warehouse. GSK¶s International Promotion and Marketing Code, applicable to Emerging Markets and Asia Pacific regions, will be subject to its regular two-year review. The last revision incorporated major structural change to align with the structure and content of the IFPMA code and indeed goes further in many cases.
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Home Responsibility Ethical conduct Marketing ethics Direct-to-consumer advertising
Corporate Responsibility Report 2008 Direct-to-consumer advertising Approach
Performance
In the US it is legal to advertise prescription medicines to consumers through TV and print advertisements. This is known as direct-to-consumer (DTC) advertising. New Zealand, Bangladesh and Korea also allow limited DTC advertising. DTC advertising of prescription medicines is not permitted in other markets. Promoting the use of prescription medicines directly to consumers can raise concerns. Critics believe that it encourages people to request unnecessary treatment, adding to the burden on healthcare systems. We believe that responsible pharmaceutical advertising is a useful source of health information for patients. It helps to increase knowledge of conditions and educates patients about treatment options. In countries such as the US where DTC advertising is common industry practice, we would be at a competitive disadvantage if we did not promote our products in this way. Patients must still consult with their physicians about their condition, the appropriateness of a prescription medicine and obtain his or her consent before receiving such medicines.
Prescription medicines in the US Our DTC Communications policy is based on the PhRMA Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines. We have a detailed approval process for DTC advertising, which includes review by legal, regulatory and medical specialists as appropriate. All US marketing employees have received training on our DTC policy. All DTC television advertisements, including audio and visual components, are submitted to the US Food and Drug Administration (FDA) for review at least 30 days in advance of broadcast. Members of the public and healthcare professionals can send comments or complaints on DTC advertising to PhRMA¶s Office of Accountability, which reports the comments and the responses of the companies to the FDA. The FDA Amendments Act 2007 imposes restrictions on DTC advertising. It gives the FDA the ability to require submission of DTC television advertisements 45 days prior to dissemination and imposes a new standard on presentation of safety information in broadcast advertisements. Companies responsible for false or misleading DTC advertisements can now be fined up to $500,000. We have implemented these provisions in our DTC advertising in line with the Act¶s requirements. We fund disease-awareness campaigns which are designed to increase understanding of a specific disease but are not linked to the promotion of GSK products. These are also governed by our DTC policy. Our disease awareness campaigns include television and print advertisements, and direct mail. They do not mention specific GSK products but make people aware that treatments are available for their condition and encourage them to see their doctor. Campaign materials are branded to indicate that they have been produced by GSK.
Over-the-counter medicines and consumer healthcare products Our advertising for over-the-counter medicines, oral healthcare and nutritional products is governed by national regulations or codes of practice for advertising. Our over-the-counter medicines are also promoted
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to pharmacists, doctors and dentists by our sales teams. We belong to the Consumer Healthcare Products Association in the US and comply with its Code of Advertising Practices for Non-prescription Medicines. GSK Consumer Healthcare advertising is reviewed by Copy Review Committees in our larger markets, or by medical and legal personnel in our smaller markets, before publication to ensure it meets our standards.
Advertising to children Our guidelines for advertising to children prohibit advertising designed to appeal to, or targeted at, children below the legally mandated minimum age. For example, to comply with our guidelines in the UK we do not buy advertising space in children¶s media and we do not supply vending machines to primary schools. Sports star sponsorship is important to brands such as Lucozade Sport. Our guidelines state that only people who set an appropriate example should be used for sponsorship, and they should have an appeal that is not solely to children below the age of 13. Our principles for DTC advertising in the US
Our policy requires that DTC advertising should: Dedicate an appropriate amount of time to educating healthcare professionals prior to initiating DTC promotion for a new medicine or new therapeutic indication for an approved medicine Be designed to educate consumers about the medicine and the condition for which it is prescribed Be accurate and supported by evidence Include information on the risks and benefits of treatments Provide information on other treatment options such as diet and lifestyle changes, where these are referenced in the prescribing information for a product Only be targeted at an audience at least 80 per cent of whom are adults
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Home Responsibility Ethical conduct Marketing ethics Direct-to-consumer advertising
Corporate Responsibility Report 2008 Direct-to-consumer advertising Approach
Performance
In 2008 no problems with GSK US DTC advertising were identified by the FDA nor did we receive any comments from the PhRMA Office of Accountability relating to GSK DTC print advertisements. In February 2009 GSK received a letter from the US Food and Drug Administration Division of Drug Marketing, Advertising, and Communications saying that a television advertisement presented a misleading suggestion of superiority to other drug therapies and overstated the efficacy of GSK¶s product Avodart. The advertisement aired from March to September 2008 and was no longer in use at the time the letter was received. We are continuing to make every effort to ensure that future advertisements incorporate the directions provided to us by the FDA.
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Home Responsibility Ethical conduct Training and awareness
Corporate Responsibility Report 2008 Training and awareness Training and awareness programmes help employees understand the importance of ethical conduct and to apply our policies in practice. New employees in the UK and the US complete induction training on our Code of Conduct, which is available on our intranet site. Our annual management certification programme requires managers to confirm that they comply with our ethics policies. The programme covers over 14,000 managers worldwide. Managers can access three e-Learning modules on ethical leadership. Specialised training is provided for employees working in R&D, manufacturing and sales and marketing, where there are additional regulatory requirements. Our corporate ethics and compliance intranet contains links to all company policies, ethics and compliance training for new recruits, an ethical decision-making model, an ethics quiz, contact details for compliance officers and the free phone numbers for our Global Confidential Reporting line. As well as this phone line which is available in over 25 languages and can be used for reporting any concerns employees may have relating to compliance with our policies and the Code of Conduct, we also have an Integrity Helpline based in the US. This provides advice to callers, from both within and outside the company, on Code of Conduct issues, as well as being a reporting channel. Training for employees working in sales and marketing includes: Induction training and testing on our marketing code of practice Detailed training for sales representatives on the medicines they promote and the diseases they are designed to treat Regular refresher courses held at least once a year Regular management updates in Europe, Emerging Markets and Asia Pacific and the US on the types of unethical conduct detected and disciplinary actions taken Ethics training in practice
Ethics training helps employees make the right decisions and apply our policies in practice. For example, new employees are encouraged to ask themselves the following questions before making a decision: Is it legal and ethical? Is it consistent with GSK policy and the Code of Conduct? Is it consistent with GSK¶s Mission and Spirit? Can I explain it to my family and friends? Would I be comfortable if it appeared in a newspaper? We also run ethical decision-making training for established employees and leaders. During training employees explore ethical dilemmas they may face in their work and receive guidance to help them understand the appropriate response. This is one example of an ethical dilemma: When you arrive at the office, there is a large gift basket filled with very expensive chocolates and other gourmet treats on your desk. You estimate its value at $250. Enclosed is a note from a consultant: ³Thanks for choosing us as your consulting partner. We look forward to working with you.´
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You should: a. Keep the gift for yourself. Since you already chose the consultant, the gift can¶t be considered as having influenced your decision b. Call the owner and explain that while the gift was certainly thoughtful, you cannot accept it because it is against GSK policies to accept such an item. Tell her that you will be returning the gift basket and that you look forward to working with her firm c. Put the goodies by the office coffee station for everyone to enjoy The best solution is to return the gift, answer (b).
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Home Responsibility Ethical conduct Training and awareness Leading by example
Corporate Responsibility Report 2008 Leading by example Our senior managers are expected to lead by example by complying with company policies and by supporting their staff to do the same. This is reinforced annually by a formal µManagement certification on business ethics¶ in which over 14,000 managers confirm their understanding and compliance with the company policies contained in the Employee Guide to Business Conduct. Management certification promotes awareness of GSK¶s ethical standards and company policies. It emphasises the importance of the company policies to thousands of other GSK employees who, in the course of their daily activities, must comply with the law and company policies in the conduct of company transactions. This is the full certification statement: I understand that GSK is committed to the principle of performance with integrity, and in particular, to ensuring that its activities comply with all applicable laws. I have received a copy of or have access to the GSK Code of Conduct (POL-GSK_001) and other GSK corporate policies through the Corporate Policy Index page accessible on the Corporate Ethics & Compliance Community. I have read and understand The Employee Guide to Business Conduct, accessible on the Corporate Ethics & Compliance Community. I have complied with applicable laws, regulations, and GSK corporate and local policies and procedures. I understand my responsibility to promptly report any actual or suspected violations of the law, regulations, or GSK corporate and local policies and procedures. I have reported all actual or potential compliance issues of which I am aware concerning legal requirements or company policies. The following statements are also applicable to supervisors with personnel management responsibility: All people under my supervision have received copies of or have access to the GSK Code of Conduct and other applicable GSK policies and have been informed of their responsibilities. I have put in place appropriate measures to ensure that the people under my supervision comply with applicable laws, regulations, and GSK corporate and local policies and procedures while working on behalf of GSK. All new hire employees under my supervision have completed or are scheduled to complete the GSK Corporate Ethics & Compliance new hire training program at GSK Induction or through the Corporate Ethics & Compliance Community. I have read, understood and shall comply fully with the policies and procedures specified in the learning activity.
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Home Responsibility Ethical conduct Training and awareness Performance
Corporate Responsibility Report 2008 Performance and plans Global GSK intends that ethics and integrity are a part of all that we do; therefore, the following key ethics and integrity principles and messages are provided to our business training groups across the company for integration into regular training courses: GSK has an unwavering commitment to conducting business with integrity and in full compliance with the law Every GSK employee is personally and professionally responsible for helping GSK maintain its organisational integrity and good reputation. Profits without principles are short lived When faced with difficult ethical situations, reference the ethical decision-making model. - Is it legal? - Is it consistent with company policy? - Is it consistent with GSK values and Code of Conduct? - Can I explain it to my family and friends? - Would I be comfortable if it were printed in the newspaper? - Will it benefit all or most of the people involved? Our training describes where GSK employees can obtain assistance: - Manager - Corporate Ethics & Compliance web community - Human Resources - Legal - Compliance officers and champions - Integrity Helpline based in the US Other training and awareness activity in 2008 included: Over 14,000 managers completed our self-certification process in 2008 We launched training for new general managers and site directors on their compliance responsibilities, as well as wider monitoring and compliance arrangements at GSK We added µPerforming and Leading with Integrity¶ training to our induction programme. This focuses on ethical decision making and our code of conduct We raised awareness of our Global Confidential Reporting Line through an extensive poster campaign and awareness programmes on our intranet. Our Confidential Reporting phone line is now available in 70 countries and more than 25 languages Our target to set ethical leadership objectives for all of our top managers was put on hold during the transition to the new CEO. We are planning to implement, track and assess ethical measures at the executive level of the company in 2009.
United States Over 9,900 employees and contractors completed compliance refresher training. New hire training was completed by 728 people
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We launched a redesigned training curriculum for new US Pharmaceuticals field sales employees. The curriculum integrates training on ethical commercial practices with sales training, rather than providing it as stand-alone modules. We will integrate compliance training with a range of other sales training programmes in 2009 We added an ethics section to our employee manual of commercial policies. This expands on the policies to provide information that helps people make the right decisions during commercial interactions
Japan Our promotion compliance team trained 2,846 employees on the GSK Promotional Code, including the entire sales force, marketing employees, clinical trial monitors and other employees who interact with healthcare professionals. All employees who took this course submitted a letter which pledged compliance with our standards and the law.
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Home Responsibility Ethical conduct Monitoring and compliance
Corporate Responsibility Report 2008 Monitoring and compliance Approach
Performance and plans
All our managers are accountable for managing risks of non-compliance with our policies in their areas of responsibility. They are overseen by and can seek advice from our corporate ethics and compliance department that promotes effective compliance programmes, addresses compliance issues, and reports problems and progress to senior management and the Board. We have a dedicated compliance officer for each of our business units: R&D, Manufacturing, Vaccines, Pharma Europe, Pharmaceuticals Emerging Markets, Pharmaceuticals Asia Pacific and Japan, Consumer Healthcare, Corporate, US Pharmaceuticals, and additional compliance representatives in some markets. Compliance officers are senior managers with direct access to the leadership teams of GSK functions. They are a source of expertise for anyone with a question on ethics or GSK policies. Our corporate compliance officer reports directly to the CEO. To further develop GSK¶s internal infrastructure, new full-time compliance director positions were also established during 2008 in Latin America, Middle East-North Africa, Asia Pacific and China. This further demonstrates our ongoing commitment to provide dedicated and focused support to our senior management teams globally. Previously such support was via 'champion' roles which were fulfilled by individuals who had additional functional responsibilities beyond ethics and compliance.
Risk management Our Risk Oversight and Compliance Council (ROCC), which includes several Corporate Executive Team (CET) members, oversees risk management and internal control activities. The ROCC is supported by GSK¶s corporate assurance department and corporate ethics and compliance department. GSK¶s corporate compliance officer, who chairs the ROCC, regularly reports on significant risks to the CET and the Audit Committee of the Board. For more information on risk management see the corporate governance section of our Annual Report. Monitoring for sales and marketing Sales representatives are supervised by their managers who regularly monitor educational events, visits to doctors and expenses. We use a risk-based approach to determine the frequency of our checks on different districts and individual sales representatives. In the US, sales representatives that receive inquiries from physicians about off-label uses of GSK products must notify our medical information department, which responds to the inquiry via a medical information letter. Sales representatives must not solicit off-label questions from physicians. Frequent medical information letter requests by a sales representative can indicate that the employee is prompting questions and promoting off-label uses of GSK products. We monitor requests for medical information letters. Our internal audit department regularly audits our sales and marketing practices globally. Monitoring for payments to healthcare professionals and organisations Payments are recorded and monitored in different ways in different countries. For example, in the US we have introduced a state reporting system for expenditure with healthcare professionals, in line with legislation in several US states. In Japan, payments to individual healthcare professionals and medical institutions are monitored on a quarterly basis and the results are reported to promotion compliance officers and our internal audit department These systems help us to identify situations where excessive meals and gifts may have been provided by
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GSK. Reporting channels Employees are encouraged to seek help on ethical issues and to report any concerns or suspected cases of misconduct. They can do this through their line manager, the Corporate Ethics & Compliance department, a compliance officer or compliance champion, GSK¶s Human Resources and Legal departments, or through our Global Confidential Reporting Line or the Integrity Helpline in the US. In the US, employees can also report concerns through an offsite post office box or via email. Reporting channels are promoted through the Employee Guide to Business Conduct, on the GSK intranet and during training. Addressing misconduct Our Corporate Ethics & Compliance department monitors and tracks allegations and suspected legal, ethical or policy infractions. It ensures that all such allegations are appropriately investigated. Disciplinary action, up to and including dismissal, is taken where necessary. Serious violations of our policies are reported to the Audit Committee of the Board. Back to top
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Home Responsibility Ethical conduct Monitoring and compliance
Corporate Responsibility Report 2008 Monitoring and compliance Approach
Performance and plans
Reviewing our compliance and risk management strategy In 2007 we conducted a review of our corporate ethics strategy. Based on the results of the review, we took steps during 2008 in the following areas to further embed an ethical culture at GSK: Recruitment ± we included questions on ethics and integrity in our recruitment process and our GSK Managers Interview Guide. We carried out more extensive pre-employment checks to ensure we recruit people who share GSK¶s values Training ± we extended ethics and compliance induction training to new employees worldwide. We provided extra training and guidance for employees committing minor breaches to prevent them committing serious breaches in future Global Confidential Reporting line ± we extended our independently managed reporting line to all countries where we operate. For many countries, employees can call in their native language. We undertook an extensive intranet and poster campaign to raise awareness of this service Senior management ± we developed new training and awareness programmes for site directors and general managers who are key representatives of GSK in the countries and locations where they work. This included individual briefings by the executive team for new appointees on their compliance responsibilities Policies ± we streamlined the administration of our corporate policies and procedures. This involved reducing the number of policies and procedures by half, and requiring that employees need only have detailed awareness of the policies and procedures specific to their role Financial fraud - we established a new fraud risk assessment tool to help us prevent financial fraud. Our finance leadership team will regularly review all financial fraud cases Progress on meeting our strategy review objectives is reviewed twice a year by the GSK Audit Committee of the Board. In 2009 we plan to further enhance our Global Confidential Reporting phone line facility. Internet reporting will be introduced in selected countries and languages as our supplier evolves this technology and the number of languages available.
Addressing misconduct In 2008 1,113 employees were disciplined for policy violations Of these, 266 were dismissed or agreed to leave the company voluntarily (known as separations) Other disciplinary actions included documented warnings (847 instances) and financial penalties The 1,113 disciplinary actions included 240 cases of employees breaching sales and marketing codes These 240 cases resulted in 30 dismissals or separations from the company. All the other 210 cases resulted in documented warnings In addition to appropriate discipline, employees staying with the company received retraining and increased monitoring. In some cases retraining is also extended to an employee¶s colleagues to prevent them making
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similar mistakes. The main types of violations this year included: Marketing and promotional activities Good manufacturing/good distribution practices Falsification of documents Travel and expenses claims Code of Conduct issues
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Home Responsibility Ethical conduct Case studies
Corporate Responsibility Report 2008 Case studies Suitability for GSK¶s approved speaker list As well as ensuring that our employees comply with our policies, it is vital that people working on our behalf meet the highest ethical standards. In 2008, the US Pharmaceuticals Compliance Department received information through the GSK Integrity Helpline that a healthcare professional (HCP), who was engaged to speak on GSK¶s behalf, had allegedly failed to comply with company policies during promotional programmes on two consecutive days. GSK reviewed materials from one of the programmes in question and identified a number of issues and policy violations. The person was suspended as a GSK speaker pending the completion of a follow-up investigation. After further investigation, we removed the HCP from our approved speaker list. Responsible marketing for our weight loss treatment Nearly two-thirds of US adults are either clinically obese or seriously overweight. This is causing a dramatic increase in life-threatening medical conditions such as heart disease and diabetes, and adding strain to the healthcare system. But even a small amount of weight loss can greatly reduce the risk of developing associated medical problems. GSK¶s over-the-counter weight loss product, alli (orlistat 60 mg), helps overweight adults lose weight by preventing about 25 per cent of dietary fat from being absorbed in the gut. 1 It helps people lose 50 per cent more weight than diet and exercise alone. 2 alli was launched in the US in June 2007 and since then we have sold over six million starter packs. In 2008, alli received a positive opinion from the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use and in January 2009, the European Commission granted a non-prescription licence for the product. It is vital that alli is marketed responsibly so that it is used in the right way and only by those who need it. We educate physicians, dieticians and pharmacists to ensure alli is sold appropriately and patients receive the right information about the treatment. Our marketing emphasises that using alli requires lifestyle changes, including exercise and a low-fat diet, to produce the right results without unwanted side effects. The safety and efficacy profile of orlistat is well documented and has been established through data from more than 100 clinical studies. 3 We set up the website www.myalli.com to provide further support for alli users. It enables people to set targets, track their weight loss and post success stories. It includes an µam I ready for alli?¶ quiz, which asks potential users to confirm their commitment to moderating their diet, taking exercise and reading the label carefully. The site also includes µalli circles¶, an online moderated forum where users can share experiences and help each other stay focused on their weight loss targets. The forum gives us valuable feedback from patients on the effectiveness of the product, and we monitor the site for reports of adverse effects which are then reported to the FDA, and for inappropriate content. In 2008, we donated $75,000 to Dress for Success (DFS) to mark the one-year anniversary of the US launch of alli. DFS is an international non-profit organisation that provides business clothing and career support for disadvantaged women. We encourage alli users to volunteer for DFS and to donate clothing that becomes too big for them as they lose weight. DFS has so far received over 38,000 pieces of clothing from alli users. 1. Anderson J. Orlistat for the management of overweight individuals and obesity: a review of potential for the 60-mg, over-the-counter dosage. Expert Opin Pharmacother. 2007;8 (11):1733-1742. 2. alli Summary of Product Characteristics (SPC) 3. Jacob S, Togerson J. Orlistat treatment beneficial in both primary care and tertiary settings. obesity
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reviews. 2005;6(s1):166.
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Home Responsibility Ethical conduct Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders. Can one company on its own establish high standards of ethical conduct, or is an industry approach required? We set our own high standards of ethical conduct which we hope will establish a benchmark by which all companies are judged. We also work with other companies through trade associations to develop high ethical standards. We believe that it is in the best interest of patients if the pharmaceutical industry adopts common high standards of ethical conduct. This will also help to improve trust in the industry among all our stakeholders. A lot of GSK employees were dismissed for unethical conduct. Are your policies working? In 2008, 266 employees were dismissed or agreed to leave the company voluntarily as a result of policy violations. Unethical conduct occurs in all companies. We believe these figures demonstrate the effectiveness of our monitoring and compliance programmes. Furthering our ethical culture, recruiting the right people, providing the right training and tools, improving our checks and encouraging people to speak up enable us to identify and address unethical conduct in a consistent and responsive manner. Is GSK unduly influencing doctors? We take several approaches to protect against inappropriate influence of doctors, including regional marketing codes of practice, regular training and monitoring. Our policies apply to all employees and agents and commit us to promotional practices that are ethical, responsible, principled and patient centred. They prohibit kickbacks, bribery or other inducements to doctors and any promotion for unapproved uses of our medicines. Our sales force is regularly trained and supervised by managers who monitor educational events, visits to doctors and expenses. How do you prevent off-label promotion? All GSK employees dealing with healthcare professionals undergo extensive training and monitoring. They are instructed that only full and accurate information may be provided on approved uses for a medicine. It must be based on valid scientific evidence, and must be accurate, balanced, fair, objective, unambiguous and up to date. Questions from doctors on off-label uses for our products must be referred to our medical information department. In the US, additional processes are in place for monitoring these referrals to help us ensure that representatives are not promoting off-label uses. We now monitor both the volume of letters responding to questions and the types of referrals made by our individual representatives, for example the number of referrals relating to a particular product or a particular off-label use. Additionally, our internal audit department regularly audits our sales and marketing practices globally. The Advertising Standards Authority ruled that health claims in a Horlicks advert shown in the UK were unsubstantiated. Is GSK involved in false advertising? No, GSK was not involved in false advertising. In 2008, Nepali TV, a Bengali-language satellite channel aimed at viewers on the Indian sub-continent, briefly aired an advert into homes in the UK. However, the advert is intended and approved for use only in India. This was done without our knowledge. The health claims in the advert are not appropriate for the UK as the claims in the advert relate specifically to the Indian market and the Indian diet. The Advertising Standards Authority in the UK upheld the complaint against Nepali TV for broadcasting the
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advert in the UK and did not reprimand GSK. The UK Office of Fair Trading (OFT) is investigating whether supermarkets and suppliers have been wrongly sharing information on prices. Are GSK consumer products involved? In 2008 the UK Office of Fair Trading (OFT) began an investigation into potential breaches of competition law by more than 20 companies, including GSK. The OFT is looking into claims that data on pricing was passed to rival companies through suppliers. It has asked GSK for our cooperation, but we have not been accused of breaking the law. We do not tolerate unethical behaviour. Corrupt and anti-competitive behaviour undermines fair competition, inhibits economic development and is bad for economies, business and people. Our code of conduct sets out our expectations for employees and we conduct training to ensure that we operate within the letter and spirit of the law and maintain high standards of ethical business behaviour. We are cooperating fully with the OFT and we will take disciplinary action, up to dismissal, if a GSK employee is found to have breached our policies or the law.
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Home Responsibility Supply chain
Corporate Responsibility Report 2008 Supply chain We want to source from companies that maintain high labour and environmental standards. Inadequate environment, health and safety (EHS) and human rights standards are an indicator of poor management. This can impact on quality, compromise patient safety and impede continuity of supply of essential medicines. Association with poorly performing suppliers could also damage our reputation. We conduct detailed assessments of new and existing suppliers to monitor their performance on EHS and human rights issues. We work closely with our suppliers to prevent disruptions to the supply of our key medicines. Counterfeit drugs can pose a serious threat to patients. We build anti-counterfeiting features into our products and packaging and we take steps to prevent criminals from making and distributing fake GSK products We are also working to assess the environment, health and safety impacts of our manufacturing suppliers. Our Supply Chain
Number of suppliers: 90,000 Spend: 8.4 bn
We buy goods and services from around 90,000 suppliers. Our supply chain is complex: it ranges from strategic relationships with suppliers that manufacture active pharmaceutical ingredients, intermediates, raw materials and packaging for GSK medicines to contracts for goods and services such as office equipment, cleaning and security.
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Home Responsibility Supply chain Responsibility and our supply chain
Corporate Responsibility Report 2008 Responsibility and our supply chain Our approach to ensuring high standards for our global suppliers includes: Pre-assessments of potential suppliers to gather information and to help evaluation Inclusion of human rights clauses in all supplier contracts and full environment, health and safety (EHS) requirements in contracts for critical suppliers Review of EHS and human rights in routine supplier engagements (for example business performance meetings) EHS audits of potential and existing suppliers Regular progress monitoring and additional advice and technical support
Supplier contracts Our supplier contracts contain EHS requirements based on our global EHS standards and human rights clauses based on the International Labour Organization conventions and the UN¶s Universal Declaration of Human Rights. Companies must agree to our EHS and human rights requirements before they can be included in the selection.
Risk-based approach Our supply chain is large and complex so we use a risk-based approach to target our efforts. We focus on µcritical suppliers¶ which are mostly based in Europe, North America and Asia and account for approximately 30 per cent of our supplier spend. Critical suppliers include contract manufacturers and suppliers that present the greatest risk to GSK on one or more of the following issues: Relevance to the supply of essential medicines Threats to continuity of supply The value of affected products to GSK Regulatory requirements Hazards associated with manufacturing processes and materials Environmental impacts We develop long-term relationships with critical suppliers and conduct regular monitoring to support the uninterrupted supply of high quality materials and services to GSK.
Training for GSK procurement teams We train all new procurement employees in our standards and requirements for EHS and human rights . This emphasises their role in promoting compliance with the standards. Key procurement employees, including procurement managers, receive ongoing training on these topics. In 2009, we will develop new sustainable procurement guidelines, with supporting training plans, which will focus on sourcing:
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Materials from sustainable sources Products with recycled content Energy-efficient equipment
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Home Responsibility Supply chain Responsibility and our supply chain Human rights clause
Corporate Responsibility Report 2008 Human rights clause Our supplier contracts contain a human rights clause (below) which is based on the International Labour Organizations conventions and the UN¶s Universal Declaration of Human Rights. We may amend the exact wording of the clause during negotiations with suppliers or during translation to suit local law. These changes will not reduce the contractual impact or intent of the clause.
The GSK standard contract clause for Ethical Standards and Human Rights Unless otherwise required or prohibited by law, the Supplier warrants, to the best of its knowledge, that in relation to the supply of goods or services under the terms of this Agreement: 1. it does not employ engage or otherwise use any child labour in circumstances such that the tasks performed by any such child labour could reasonably be foreseen to cause either physical or emotional impairment to the development of such child; 2. it does not use forced labour in any form (prison, indentured, bonded or otherwise) and its employees are not required to lodge papers or deposits on starting work; 3. it provides a safe and healthy workplace, presenting no immediate hazards to its employees. Any housing provided by the Supplier to its employees is safe for habitation. The Supplier provides access to clean water, food, and emergency healthcare to its employees in the event of accidents or incidents at the Supplier's workplace; 4. it does not discriminate against any employees on any ground (including race, religion, disability or gender); 5. it does not engage in or support the use of corporal punishment, mental, physical, sexual or verbal abuse and does not use cruel or abusive disciplinary practices in the workplace; 6. it pays each employee at least the minimum wage, or a fair representation of the prevailing industry wage, (whichever is the higher) and provides each employee with all legally mandated benefits; 7. it complies with the laws on working hours and employment rights in the countries in which it operates; 8. it is respectful of its employees¶ right to join and form independent trade unions and freedom of association; 9. The Supplier agrees that it is responsible for controlling its own supply chain and that it shall encourage compliance with ethical standards and human rights by any subsequent supplier of goods and services that are used by Supplier when performing its obligations under this Agreement. The Supplier shall ensure that it has ethical and human rights policies and an appropriate complaints procedure to deal with any breaches of such policies. GSK reserves the right upon reasonable notice (unless inspection is for cause, in which case no notice shall be necessary) to enter upon the Supplier's premises to monitor compliance by the Supplier of the warranties set out in the clause above and the Supplier shall, subject to compliance with law, furnish GSK with any relevant documents requested by GSK in relation thereto. {This sub-section will only be required where there is no general right of audit elsewhere within the Agreement} Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Responsibility and our supply chain Choosing suppliers
Corporate Responsibility Report 2008 Choosing suppliers We conduct a detailed assessment of critical suppliers before they are selected. Critical suppliers include contract manufacturers and suppliers that present the greatest risk to GSK on one or more key risk areas. We use questionnaires, on-site reviews and EHS audits to assess their performance on health and safety, environmental and human rights issues. We assess potential new critical suppliers against our EHS standards. They must achieve a minimum audit score of 50 per cent against the standards if they are to join our supply chain. Following an audit, many suppliers who have not met our requirements implement plans to improve their EHS performance. We monitor their progress and in some cases provide opportunities for training and technical support to enable the supplier to achieve the required standards. We also expect suppliers who have established supply arrangements with us to make improvements and we monitor their progress through reviews and follow-up visits. The audits also include questions which help us identify potential breaches of the human rights clauses included in supplier contracts. Suppliers are asked for information on policies and practices relating to: Age limits for employees Discrimination against employees and the local population Prevention of abuse of individuals Wages, benefits and working hours (whether they meet the legal minimum) Rights for workers to organise and recognition of worker organisations These questions do not contribute to the EHS audit score, but may be a reason not to progress business with a supplier. Read about our audit programme which ensures compliance with quality standards
Back to top
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Home Responsibility Supply chain Responsibility and our supply chain Monitoring and engagement
Corporate Responsibility Report 2008 Monitoring and engagement Approach
Performance
In order to maintain GSK standards in our supply chain, we routinely interact with our suppliers through reviews and follow-up visits by procurement, quality and EHS staff. We consider EHS and human rights issues in all these interactions. We hold global and regional supplier review meetings where senior GSK managers interact with suppliers on key issues. We provide contract manufacturers with information on the EHS risks associated with the GSK materials they are producing or handling. Our supplier booklet won working with GSK includes our ethics policies and requirements. We conduct regular EHS audits of critical suppliers of pharmaceutical and consumer healthcare products. We focus on the 150 higher-risk suppliers. Supplier facilities are evaluated against our EHS standards and must achieve a score of at least 50 per cent against these standards to demonstrate acceptable performance and to support continuing supply arrangements. Suppliers develop improvement plans based on the audit findings and we follow up to monitor progress against these plans. Read a case study on how we helped a supplier to improve its EHS performance in 2008. We will provide feedback to suppliers if we identify any issues through the questions relating to human rights . We will require corrective action if the issues present a potential breach of the human rights clause included in supplier contracts.
Suppliers of promotional items Many of the gift items for our Indian business are sourced from within India in an industry with a higher risk of the use of child labour. We conduct unannounced spot checks for these suppliers, often during the night. These focus on maintaining quality standards but are also used to check that suppliers are not using child labour. The spot checks are conducted by GSK procurement and regional sales staff. We have used the findings from the programme in India to inform our promotional supplier qualification process in other regions. We have begun to conduct more detailed inspection of assembly sites where possible and have added extra checks in regions where child labour is more common. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Responsibility and our supply chain Monitoring and engagement
Corporate Responsibility Report 2008 Monitoring and engagement Approach
Performance
In 2008, we conducted 30 supplier audits and 20 reviews.The average audit score against GSK EHS standards was 62 per cent; the highest score achieved was 84 percent and lowest was 40 percent. 2008 EHS audit scores of key suppliers
* Americas = Canada, North America and South America regions The higher average scores in North America and Europe, in contrast to the lower average scores in Asia, are largely related to the maturity of EHS management and the supporting legislative framework and its enforcement in these regions. The broad range of scores in the Asia region reflects the higher performing suppliers where there has been long term intervention from GSK. The lower scores relate to suppliers where we have undertaken initial audits and found significant deficiencies in EHS management and risk control. Five suppliers failed to meet our minimum requirement of 50 percent against GSK EHS standards. Potential new suppliers that scored below the minimum level were either not progressed or work is underway to improve performance to acceptable levels. We work with existing suppliers to ensure necessary improvements are made within an agreed timeframe and that GSK standards are applied in our supply chain. The most significant audit findings in 2008 occurred mainly in emerging economies. These included: No infrastructure for fire protection and poor emergency response capabilities Absence of fundamental risk controls for process safety Poor control of exposure to hazardous substances Poor waste management and environmental controls Frequent regulatory findings No significant issues were identified relating to the human rights questions we ask during audits.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
In 2008 we continued to work with a number of key suppliers to help improve their EHS performance. This included: Developing closer relationships - We have two full-time positions, in China and India, to support our work with audited suppliers and improve their EHS performance. Their work includes helping the suppliers to develop improvement plans and providing them with coaching opportunities. Read more in our case study on how we helped a supplier to improve its EHS performance in 2008. Attending supplier forums through the R&D-based Pharmaceutical Association Committee (RDPAC), an industry consortium in China. The forums provide the opportunity for GSK to engage with suppliers, and for supplier companies to take advantage of training and networking. Making progress in a pilot project for a strategic supplier to achieve µHighly Protected Risk¶ (HPR) status. To achieve HPR status, a µbest in class¶ insurance industry designation, companies must adopt an engineering approach to minimising property and supply chain risks. Our plan is to extend this to other strategic suppliers Number and type of audits in 2008 Americas*
Europe
Asia
Africa
Total
Type of supplier
Primary (raw materials, intermediates and active pharmaceutical ingredients)
3
12
17
0
32
Pharmaceutical (formulations)
3
5
0
1
9
Consumer Healthcare (excipients, actives, raw materials)
0
1
11
0
12
Type of engagement
Audit
4
13
16
0
33
Review
2
5
12
1
20
Average audit score (per cent)
79
68
53
-
Number of suppliers audited between 2002 and 2008
Total number visits
Americas*
Europe
Asia
Africa
Cumulative Total number visits
2002
9
0
8
1
0
9
2003
18
0
12
6
0
27
2004
29
3
9
17
0
56
2005
40
7
8
23
2
96
2006
32
0
13
18
1
128
2007
55
10
8
37
0
183
2008
53
6
18
28
1
236
* Americas = Canada, North America and South America regions
Suppliers of promotional items In 2008 we conducted five unannounced spot checks of promotional goods suppliers in India (at least one visit for each company supplying promotional goods to our Indian business in 2008). These uncovered no
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evidence of child labour.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Responsibility and our supply chain Supplier diversity
Corporate Responsibility Report 2008 Supplier diversity Small and minority-owned companies are often under-represented in the supply chains of large companies. In response, the US government and many large companies require their suppliers to source from diverse companies. The Broad-Based Black Economic Empowerment Bill 2003 in South Africa includes similar requirements. We are working to increase the diversity of our supply chain by providing opportunities for small, diverse businesses to provide us with goods and services. This helps diverse suppliers to sustain their businesses, create jobs and boost their local economies. Our business also benefits. Beyond complying with regulations, supplier diversity encourages innovation and exposes us to new perspectives and fresh ideas.
US programme In the US, we have a dedicated team working to create opportunities for diverse suppliers to work with GSK and to channel our procurement spend to women and minority-owned companies. Its activities include: Participating in national and local diversity councils Mentoring high-potential diverse suppliers and providing improvement grants to help them expand their business with GSK and other corporations. Read more in our case study Sponsoring diverse business leaders to attend executive programmes at the Tuck School of Business and Kellogg School of Management Sponsoring and attending outreach and networking conferences We co-sponsor the Congressional Black Caucus Foundation (CBCF), a non-profit organisation that supports African Americans and under-served communities in the US. We are donating $500,000 between 2005 and 2009 to the Foundation to provide training to help make diverse businesses more competitive. We also support an initiative, run by the CBCF, to help change federal policy that can restrict long -term relationships between minority- and women-owned businesses and major corporations. We sponsor Roanoke Online, a technology company that hosts an online database and electronic sourcing system for diverse suppliers. This gives large companies, including GSK, better access to diverse suppliers. Corporations gain access to a large, diverse pool of contractors, which ultimately helps them lower their costs, while the small diverse suppliers get the chance to grow their businesses through increased opportunities to supply companies traditionally beyond their reach. As part of the Adopt a Neighbourhood for Development initiative, our procurement and community relations teams work with local communities in Durham, North Carolina, and Philadelphia, Pennsylvania. These areas are historically deprived and are often overlooked by companies when choosing where to locate their businesses. GSK provides an annual grant to support self-development within the communities to make these areas more attractive as business locations.
Outside the US GSK¶s dedicated supplier diversity team is based in the US, but all procurement employees worldwide are responsible for supporting diverse suppliers where possible. We are a sponsor of the Global Link Programme as part of our role on the International Advisory Board of the US National Minority Supplier Development Council. The Programme helps diverse suppliers develop partnerships with local businesses around the world. In collaboration with two other pharmaceutical
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
companies, we paid for ten US-based minority-owned companies to visit South Africa in late 2007. The companies met diverse South African businesses and got the chance to form partnerships to help them compete globally. We have also participated in similar trips to Australia, Brazil and China. The initiative has enabled GSK to invest in the local economies of communities we serve and helps ensure our supplier base reflects the diversity of those communities. GSK is a member of the new UK Minority Supplier Development Council. The Council forms a link between corporations and certified minority business enterprises, with the aim of increasing procurement and business development opportunities.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Responsibility and our supply chain Fair treatment of suppliers
Corporate Responsibility Report 2008 Fair treatment of suppliers It is important that we foster relationships with our suppliers which are characterised by mutual trust and respect. GSK has established procurement policies which require high standards of ethical conduct and integrity. Our general terms and conditions are on our website. As part of our supplier review process, we have a two way dialogue to identify areas for mutual improvement and to provide an environment where suppliers can discuss issues and present new ideas. We support impartiality in all phases of the procurement cycle. Our global electronic bid system ensures all suppliers are treated fairly and equally. The vast majority of suppliers that provide goods and services to GSK are registered on the system. Companies that are invited to bid to supply GSK all receive the same information at the same time, for example invitations to compete and specifications of the supplies required. In 2008, the system managed over 8,000 bidding and negotiation-related events in over 50 countries. For highly competitive goods and services we allow suppliers full transparency of seeing where their bids rank against their competition. Payment of suppliers From September 2008 GSK changed its standard payment terms for uncontracted suppliers in the UK and US from 30 days from the receipt of the invoice to 60 days. We will review our terms and conditions with contracted suppliers on contract renewal or earlier. This step has been taken as part of a project to reduce working capital. We recognise that this may impact the cash flow of our suppliers. However, the new 60-day term brings us more in line with the practice in other industries and is faster than the terms set by some other companies. We realise this may cause genuine financial difficulty for some organisations and we evaluate the implications of this on a case-by-case basis.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Maintaining quality
Corporate Responsibility Report 2008 Maintaining quality Maintaining the quality of the products we make and the materials we buy is essential to the safety of patients and the success of our business. We conduct quality assessments for all suppliers of ingredients and packaging materials used in all of our products. We agree specifications for our ingredients and packaging materials with our suppliers and apply a set of global auditing standards for each type of ingredient and packaging material that we buy. We use a risk-based approach to determine the frequency of audits. In 2008 we conducted 558 audits of our ingredient and packaging material suppliers, compared to 776 in 2007 and 740 in 2006. On receipt at GKS sites, samples are taken and testing is performed according to a testing protocol. All samples are tested for identity. Every batch is also tested against our quality specification. Examples of additional measures in place to maintain quality in our supply chain and prevent contamination include the use of dedicated transport, use of tamper evident seals and the use of sophisticated analytical tools to check the authenticity of the materials we receive. Helping suppliers to meet our quality standards We conduct quality assessments of all potential suppliers. This enables us to identify companies that meet our required standards as well as those we can work with to make the necessary improvements. For example, we identified one of our existing chemical suppliers in Asia that had the expertise to supply the final active ingredient for a GSK product. We worked closely with the supplier to help them develop the technical processes and quality standards to begin trial manufacturing in 2001. This included site visits to advise on configuration of plan and building modifications and assistance in preparing documentation required by regulators. In 2006, the US Food and Drug Administration conducted a four day quality and compliance inspection of the site, which resulted in no adverse findings and approved the site for supply to the US market. Raising employee awareness of our commitment to quality In 2008, Andrew Witty, GSK¶s CEO, endorsed a new, internal quality statement which stresses the importance of quality across all of our business activities, including the critical aspect of product quality. We raised awareness of this statement through discussion at internal Quality Councils throughout our business units, through new articles on our global intranet site, myGSK, and through posters for display at all facilities. Quality statement
Quality is at the heart of all activities that support the discovery, supply and marketing of products to our patients and customers. Quality is critical to building trust with society and, therefore, to our future business success. Andrew Witty, Chief Executive Officer
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Security of supply
Corporate Responsibility Report 2008 Security of supply Ensuring a continuous supply of high quality medicines is essential to the patients who depend on our products, as well as to the success of our business. It is vital that security of supply is not compromised at any stage of the distribution chain. We prepare for major incidents that may disrupt supply, ranging from large-scale theft of products to natural and man-made disasters near a facility. Strategy directors from each therapy area have overall responsibility for security of supply. Divisional heads meet our procurement teams every month to discuss any potential issues. GMS (our manufacturing business) implements contingency plans for µmedically critical¶ products. We define products as µmedically critical¶ if life-saving or those where if they were not available to patients, there is likelihood of serious detriment to health and there is no known alternative. These plans are defined on a product-by-product basis and may include holding sufficient stocks of products or active pharmaceutical ingredients. We work with all critical suppliers to encourage them to implement their own contingency plans. In high-risk countries we will set up joint ventures to ensure that we maintain control over the distribution chain. We have three global contracts for suppliers that deliver goods between GSK facilities and distribute products to market. We conduct regular high-level operational reviews of these suppliers, which include security elements. Read about the measures we are taking to protect our employees in the event of a pandemic flu outbreak to ensure the supply of critical medicines is not disrupted.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Counterfeiting
Corporate Responsibility Report 2008 Counterfeiting Approach
Performance
According to the World Health Organization (WHO), less than one per cent of pharmaceutical products sold in developed countries are counterfeit, but in the developing world this figure may be higher than 10 per cent, and up to 30 per cent in some countries. Counterfeit drugs come in many variations, and may contain: None of the legitimate active ingredient The active ingredient in reduced or sub-therapeutic amounts A completely different and/or inappropriate active ingredient Impurities such as unapproved colourants or microorganisms Packaging that falsifies the product description or expiry date Most counterfeit drugs are not subject to quality control, hygiene standards, testing of ingredients and monitoring of product specifications or equipment. Counterfeiting is a threat to public health, potentially causing harm to patients and even death. We add anti-counterfeiting features to our product packaging. These include holograms, security seals, complicated background patterns that are difficult to photocopy or scan, as well as a wide variety of covert identifiers which are added using print technologies and sophisticated markers. These help us to identify counterfeits and gather evidence against offenders. Our Packing Design Technology and Security team in the UK carries out forensic examinations of all suspected counterfeit GSK products. Our sales representatives worldwide also play an important role in helping to discover counterfeit products through continual observation of the local market. Our Corporate Security department investigates every potential case of counterfeiting. It uses internal and external investigators to collect information, which we then assess and report to the relevant government authorities to set in motion official law enforcement action. As well as removing fake products from the market, one of our primary aims is to trace the products back to source, to shut down the manufacturers and their partners (for example the packaging printers and distributors). We provide training for regulatory authorities, such as the State Food and Drug Administration (sFDA) in China, law enforcement agencies and customs officers in many parts of the world. GSK works very closely with the wider pharmaceutical industry to investigate cases of counterfeiting and we also raise awareness with governments internationally, pressing for stricter laws and more severe penalties. GSK is a founding member of the Pharmaceutical Security Institute (PSI), which coordinates information collection and investigations within the industry internationally. The PSI is influential in helping to shape anti counterfeiting policy among national governments and international organisations. Together with the PSI, GSK is a major contributor to the WHO¶s internationally represented anti-counterfeiting working groups. Internet pharmacies
There is evidence that a large number of internet pharmacies are involved in the sale of counterfeit or diverted medicines or illegal generic substitutions (switched at the time of delivery for the requested
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
brand name product). Some internet pharmacies provide sub-standard product, engage in a fraud against the customer (using their credit card information for other fraudulent activity) and ignore local laws and regulations relating to licences, prescriptions and patient information, seemingly operating with immunity from prosecution. Internet pharmacies have flourished over the past few years and it is likely that this rise will continue as it provides a lucrative, low-risk opportunity for direct selling to patients in a global and largely unrestricted market. The UK Medicines and Healthcare products Regulatory Agency estimated in 2004 that 600,000 British patients purchased prescription only medicines on the internet and the US FDA reported that 100,000 pills are purchased through internet pharmacies each month in the state of Kentucky alone.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Counterfeiting Performance
Corporate Responsibility Report 2008 Counterfeiting Approach
Performance
In 2008 there were 289 reported cases of counterfeiting of GSK products. These resulted in 94 raids, during which 84 suspected counterfeiters were arrested and 7 million worth of counterfeit products were found. Of the 94 raids, 22 took place at criminal manufacturing facilities and 54 at wholesale/distribution outlets. The 22 factories represent criminal operations that were capable of mass production of counterfeit medicines and other healthcare products. The raids on these facilities undoubtedly prevented huge amounts of counterfeit product from entering legitimate markets around the world, much more than the 7 million worth of product found at the time of the raids. In 2008 there was a reduction in the number of reported cases of counterfeiting. We see this as a positive sign that anti-counterfeiting measures are working. The number of raids by GSK has risen by 30 per cent as a result of our own proactive security and investigations activity. The number of raids is not directly related to the number of reported cases of counterfeits, these are based on intelligence from our security and investigations activity. GSK is recognised as a leader by the industry in combating counterfeit medicines, and currently chairs the Pharmaceutical Security Institute.
Anti-counterfeiting
Number of reported cases of counterfeit
Number of raids
Number of arrests
Value of counterfeit products found during raids
2008
289
94
84
7 million
2007
429
71
127
15 million
2006
248
57
94
10 million
2005
334
47
31
13 million
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Case studies
Corporate Responsibility Report 2008 Case studies Mentoring diverse suppliers in the US Callis Construction Services (CCS) is a minority-owned contracting company in Durham, North Carolina. The company¶s President, Jesse Callis, took part in our diverse supplier mentoring programme, beginning in 2004, which helps suppliers form partnerships with GSK and other large corporations. As part of the programme, we assessed CCS¶s business processes and identified issues preventing the company becoming a GSK preferred supplier. Concerns ranged from management accessibility to the ability to scale up their supply to the needs of GSK. The company implemented improvements based on our recommendations which enabled it to become a preferred supplier and win business worth around $2.8 million. The success of this partnership enabled CCS to contribute to its local community. It paid for two employees to attend a local university and Mr Callis developed a training programme with Durham Technical College which prepares minority construction workers for management positions on major projects in the area. When asked about his relationship with GSK, Mr Callis said, ³GSK has been a wonderful mentor. They are a real leader in their commitment and actions to help diverse minority suppliers. In my case, they provided assistance that has led to a very significant growth of my business. This in turn has provided jobs for others in the Durham and surrounding area ensuring that monies paid by GSK stay in the local communities. This is a win for everyone involved.´
Helping to improve supplier performance In some cases we provide assistance to suppliers that fail to meet our minimum EHS and quality standards to improve their performance. This enables companies to improve their work practices and win more business. It helps us to develop the supply chain we need to provide a secure supply of high quality medicines. For example, in 2008 we provided support to a potential supplier of active pharmaceutical ingredients in India. The supplier received an audit score of 41 per cent, below our 50 per cent minimum standard. Following the audit we made recommendations for improvement, provided coaching and facilitated meetings between the supplier and expert consultants. In 2008 the supplier achieved an audit score of 55 per cent and was accepted as a GSK supplier. The audit found that the company is managing key risks effectively and has established a detailed improvement programme. We will continue to monitor progress against this improvement plan. The success of this collaboration relied on the efforts of GSK staff as well as the willingness of the supplier to recognise that improvements were needed. It has resulted in a more secure supply chain for GSK and a safer working environment for workers at the facility.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Supply chain Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders. What are you doing to raise standards in your supply chain? We have long-term relationships with our critical suppliers and we offer them training and support to help them raise standards. Our monitoring process is a key part of raising awareness of our expectations and identifying areas where suppliers need to improve. We work with our suppliers to help them make the necessary changes identified. Are there human rights risks in your supply chain? GSK¶s supply chain is large and complex, and like all similar supply chains, contains a risk of human rights violations. These risks vary considerably based on the type of supplier and the goods or service we are sourcing. Our manufacturing and R&anp;D suppliers employ skilled workers so there is a lower risk of human rights violations. Our EHS audits aim to ensure good working conditions at these supplier facilities. There are considerably higher human rights risks in suppliers that employ low-skilled workers, for example promotional goods suppliers. We conduct spot checks of these suppliers in India. Our supplier selection process aims to ensure we only enter relationships with suppliers that respect human rights. We also include clauses in contracts with all suppliers which specify that upholding human rights is a condition of doing business with GSK. What are you doing in your supply chain to plan for a flu pandemic? We have implemented a contingency plan to ensure our operations, and the supply of medically critical products, are not compromised by a flu pandemic. We are now encouraging our critical suppliers to implement their own contingency plans. You are outsourcing more manufacturing. Will this mean you have less control over your products, increasing risk for patients? The manufacture of all our medicines and vaccines is closely controlled and subject to the same quality standards, regardless of whether we produce them ourselves or outsource the process to contract manufacturers. Before outsourcing any stage of the manufacturing process, we confirm that the contractor can carry out the required processes to our high standards. All contract manufacturers must also be approved by relevant regulatory authorities, and are subject to inspection by GSK and regulators.
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Home Responsibility Environmental sustainability
Corporate Responsibility Report 2008 Environmental sustainability Sustainability has been defined as meeting the needs of today without compromising the ability of future generations to meet their own needs. GSK is embarking on a journey towards sustainability that we expect to continue for many years. As well as benefiting the environment, our sustainability efforts encourage innovation that provides a better outcome for society and help us to reduce costs. Our early environmental management programmes focused on controlling emissions and wastes from our operations through treatment and disposal systems. Our approach to sustainability is to change the fundamental process to reduce the amount of resource consumed, avoiding waste at source rather than simply treating the waste and emissions that arise. We have already begun changing our business and developing innovative new manufacturing processes. We have set initial sustainability goals to: Double the average efficiency with which we convert raw materials to finished products for new products by the end of 2010 from a 2005 baseline Reduce our energy and climate change impact per unit of sales from 2006 levels by 45 per cent by 2015 Eliminate CFCs in our products and equipment by the end of 2010 Examples of our sustainability initiatives include Reducing the amount of material resources we use such as raw materials and fossil fuels Minimising waste and recycling unavoidable waste Redesigning production processes to eliminate the production of toxic materials Reducing energy consumption and the associated carbon emissions We manage our Environment, Health, Safety and Sustainability (EHSS) programme according to a framework that sets out consistent standards of employee health and safety, environmental protection and sustainability. This framework acts as an internal regulatory system that reflects our understanding of our risks to ensure our operations comply with laws and regulations. It provides information, tools and training to help everyone at GSK meet our standards. It includes targets as set out in the Plan for Excellence to address our fundamental environmental and sustainability impacts. We also work with our suppliers to help them become more sustainable. Openness and transparency are fundamental to our sustainability performance and we will continue to engage with stakeholders to share views and dilemmas. Back to top
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Home Responsibility Environmental sustainability Plan for excellence
Corporate Responsibility Report 2008 Plan for excellence Our EHSS Plan for Excellence sets out our ten-year strategy to improve environment, health, safety and sustainability performance through to 2015. The details are developed in concert with each business so that the Plan is integrated with business plans and specific actions are identified by each business. The Plan is reviewed every five years and new targets are set. It is designed to support GSK¶s business plans and consists of three strategic priorities: Environment, health and safety fundamentals embedded in the business ± to produce and sustain high EHS performance we need to combine structured systems with the attitudes and values that create a positive EHS culture. To achieve this we need to embed awareness of environment, health and safety concerns and systems in all GSK activities Environmental sustainability ± to embrace environmental sustainability as a driver for competitive advantage we need to define the principles of environmental sustainability and progressively integrate them into the business, translating them into practical action Open and transparent external relations ± external stakeholders who have a legitimate interest in the company¶s environment, health, safety and sustainability affairs should have ready access to relevant information and the opportunity for dialogue about issues that concern them. Building open relationships and partnerships can lead to business opportunities, while failure to engage may damage our reputation Each of these strategic priorities is supported by plans with performance targets in key areas. GSK has worked with our External Stakeholder Panel to help set out our plan and to review our annual performance.
Targets Our EHSS Plan for Excellence includes company targets to improve environment, health, safety and sustainability performance. These are based on site based, practical improvement plans and forecasts from all manufacturing operations. Read more about how targets are set and view details of our company targets Back to top
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Home Responsibility Environmental sustainability Plan for excellence 7DUJHWV
Corporate Responsibility Report 2008 Targets We set company-wide targets to drive continuous improvement in managing our most significant environment, health, safety and sustainability impacts (see table). We compare proposals for company targets put forward by operations with benchmarking information and our environment, health and safety professionals, senior managers and management teams throughout the business closely review them and agree on the final target numbers. We believe it is important to set and achieve targets because lower resource consumption and less waste benefit the environment and GSK. Although we are on track to meet most of our targets, we recognise that some will be difficult to meet within the time we have set ourselves. We explain progress to the targets in the discussions on the individual metrics. Read our health and safety targets Targets and progress 2008 Target
Progress from 2006 to 2008
Material efficiency of new processes for actives
2% average for the period 20052010
Material efficiency of 1.6% achieved by 2008
Energy for operations and transport
20% reduction per unit of sales from 2006 baseline by 2010
Increased less than 1% per sales CER
Climate change impact from energy for operations and transport 1
20% reduction per unit of sales from 2006 baseline by 2010
Increased 2% per sales CER
Water
2% annual reduction from 2006 baseline per unit of sales
Reduced 11% per sales CER
Wastewater (chemical oxygen demand)
3% annual reduction from 2006 baseline per unit of sales
Reduced 6% per sales CER
Solid waste
1% annual reduction from 2006 baseline per unit of sales
Reduced 9% per sales CER
Ozone depletion 2
100% elimination by 2010 from 2006
Eliminated 83%
Air emissions (volatile organic emissions)
2% annual reduction from 2006 baseline per unit of sales
Reduced 10% per sales CER
EHS audit scores
Average: 82% by 2010 Minimum: 70% by 2010
Average 78% Minimum 62%
Sustainability targets
Fundamental targets
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1. Climate change impact is measured as CO 2 equivalent emissions 2. Includes ozone depletion potential from production and refrigeration losses Targets and performance normalised by sales are based on a constant exchange rate (CER).
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Home Responsibility Environmental sustainability Plan for excellence Journey to sustainability
Corporate Responsibility Report 2008 Journey to sustainability James Hagan, Vice President, Corporate Environment, Health, Safety and Sustainability, charts GSK¶s history of environmental management and describes how the company is making the shift towards sustainability. Sustainability is defined as meeting the needs of today without compromising the ability of future generations to meet their own needs. For GSK to be sustainable, we need to be efficient in the use of resources, including energy, water and raw materials and we need to use renewable resources. As resources become more scarce and expensive, sustainability and cost will be more closely linked. Ultimately, this means that our ability to continue to manufacture affordable medicines requires us to address sustainability. We have been working towards sustainability since 2001 when GSK was formed. Similar to other industries at that time, the companies that formed GSK started out managing their emissions and waste using treatment and disposal methods and considered management of waste a necessary cost. We soon recognised that while these µbolt-on¶ control measures are essential, they will only ever incrementally improve the impact of waste. To achieve a step-change towards sustainability, we need to make our processes more efficient to prevent waste and emissions being produced in the first place. This fundamental change requires investment in innovative solutions. Through innovation we can create more efficient processes which use less resource and reduce costs. This virtuous circle is completed when we take a portion of our sales and reinvest it in innovation. Sustainability reflects a µbuilt-in¶ approach. To begin guiding our business towards sustainability, we developed a management framework which set out a policy and consistent standards for everyone at GSK to follow. We produced a plan for 2001-2010 which outlined a timetable for achieving the goals set out in the framework and set five-year improvement targets. This plan was refreshed for the period 2006 to 2015. The plan identified manufacturing efficiency as the first area where we could make significant progress toward sustainability. We used a material balance ± a calculation that looks at the amount produced compared to the amounts of raw materials used ± to measure our material efficiency and set an improvement target to double the efficiency for our new products. Our Eco-design toolkit supports the development of these more efficient manufacturing processes. Read more about process design. We have already had some success with new medicines and we think we can improve the processes for some of our existing products as well. Climate change, one of the greatest challenges facing mankind, is a key part of our sustainability strategy. We have set targets to almost halve the amount of energy we use and the CO 2 we produce per unit of sales by 2015. Our sustainability focus extends beyond manufacturing to all aspects of our business, including R&D, sales and other activities. It also includes environmental product stewardship, the responsibility we have for the environmental impact of our medicines. Within GSK, sustainability has started to take root. As an example, our Nutritional Healthcare business has a comprehensive sustainability programme, please read this casestudy for details. They are working with suppliers to examine the lifecycle and biodiversity impacts of raw materials used, developing a ¶zero waste to landfill¶ manufacturing approach, using recycled materials for packaging and developing innovative ways to recover used bottles through reverse vending. Our Consumer Healthcare business has also developed a sustainability strategy called µBright Green¶ which includes packaging, climate change, water use, product stewardship and total supply chain goals.
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Although we have made progress in the Nutritionals business and in certain other areas, achieving our fundamental environmental improvement targets and making progress toward sustainability continues to be a challenge. In 2009 we will assess how we can achieve our targets. Of course, we will learn from both success and failure and each year we will explain why we succeeded or failed. We will also continue to broaden our view of what sustainability means to GSK. So far we have focused our attention on sustainability on R&D and manufacturing. Going forward we know we need to broaden that focus to include our sales force and offices. I realise that we have just begun this journey, and that we will need all our commitment and innovation to succeed. Our internal Sustainability Council composed of senior managers is leading our efforts. We also have an External Stakeholder Panel that gives feedback on our approach and performance and suggests improvement alternatives. I recognise the value that all of our stakeholders can bring so I welcome your views on our approach. Please feel free to let me know your thoughts by emailing me at [email protected].
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Managing EHS and sustainability
Corporate Responsibility Report 2008 Managing environment, health, safety and sustainability We manage our environment, health, safety and sustainability issues using a management system aligned with recognised management system standards such as ISO 14001 and OHSAS 18001. Our management system is based on a structured framework that starts with a vision and policy. The policy is supported by standards, guidance materials, tools, training, recognition and audits that assist the business to manage environment, health, safety and sustainability at their sites throughout key business operations. Systematic audits assess sites¶ adoption of a management systems approach to manage their risks. The framework defines our: EHSS vision and policy which set out the broad principles we expect our operations to meet EHSS standards that outline specific requirements for our company based on our EHSS risks. These meet or exceed applicable laws and regulations and are consistent with the international standards ISO14001 and OHSAS 18001 based on a management systems approach EHSS guidelines that support the EHSS standards by providing further information on the requirements of the standards and setting out an approved approach for achieving compliance. They incorporate good practice from both within and outside GSK. A wide range of information supplements the EHSS guidelines. This includes technical information and training materials to help our employees understand and implement our EHSS management system Audits that assess the implementation of management systems Reward and recognition that recognises teams who have made outstanding progress towards achieving our goals The framework includes a Plan for Excellence that sets out our strategy to improve our EHSS performance to 2015. Improving efficiency through greater integration
Our Horlicks manufacturing facility near Delhi, India is certified to the international quality standard ISO9001, the environmental standard ISO14001 and the safety standards ISO22000 and OHSAS18001. In 2008, the site introduced an integrated management system to reduce the burden of complying with these separate standards. The new system has improved efficiency and cut costs at the plant by reducing the amount of documentation required and the number of audits. Employees can now just use one instruction manual rather that separate documents for each of the four standards. This project won first place in the 2008 CEO¶s EHS Excellence Awards, Initiative-Health & Safety category.
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Home Responsibility Environmental sustainability Managing EHS and sustainability EHSS vision and policy
Corporate Responsibility Report 2008 EHSS vision and policy Vision GSK¶s environment, health, safety and sustainability (EHSS) vision is to achieve sustainable competitive business advantage and environmental sustainability through leadership and excellence. Our EHSS vision supports our mission to help people do more, feel better and live longer.
Policy Our EHSS policy describes to employees and external stakeholders what we want to accomplish in environment, health, safety and sustainability. It sets out our aspiration of global leadership and excellence and outlines the broad scope of our plans, and how they will be achieved. A revised policy was approved by the Corporate Executive Team (CET) in 2008: Leadership and continuous improvement culture We will be leaders in EHSS performance, protecting the environment and the communities in which we work and enabling healthy motivated employees to be fully engaged with our success. We will maintain a culture of continuous improvement. EHS fundamentals, risk and impacts We will embed EHS fundamentals into the fabric of the business by implementing management systems, EHS governance and risk management practices to address risks and impacts from our facilities, processes, contract research and manufacturing organisations, and suppliers. Sustainability We will integrate sustainability principles into all aspects of our healthcare business by working with our stakeholders, operating within environmentally sustainable limits, lowering our ecological footprint, enhancing social equity and addressing future issues. Open EHSS communication We will be open and transparent with all stakeholders about our efforts to address our EHSS responsibilities and our EHSS performance. The Corporate Executive Team (CET) will ensure risks are tracked until mitigated and that communication of the more significant risks is escalated within the business management structure, as commensurate with the risks and impacts involved. The CET will ensure effective management and involvement of staff with clearly assigned accountability and responsibility.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Managing EHS and sustainability Training and awareness
Corporate Responsibility Report 2008 Training and awareness We provide detailed guidelines and technical information as part of the framework for managing environment, health, safety and sustainability (EHSS). Training and awareness programmes, based on the guidelines, inform employees at all levels about risks, to create a culture where EHSS considerations are integral to the way we do business, and to help employees understand the EHSS issues specific to their jobs. Most EHSS training is managed by the sites and is specific to job roles. EHSS professionals receive induction training and undertake regular training to ensure they are aware of the latest technical information in their fields. Business leaders also receive training so that they understand their responsibilities. In 2008 we reviewed our training programme and found opportunities to improve and standardise EHSS training across GSK in 2009. We will also include EHSS competency as part of the job grading programme for all employees with EHSS responsibilities. Read more about health and safety training. We raise employee awareness of environment, health, safety and sustainability and provide training support materials through our intranet, regular internal publications and events.
myEHSS intranet Our intranet is becoming the primary mechanism to communicate within the company. There are several areas of the GSK intranet that support EHSS including the main site known as myEHSS. myEHSS is the way news about EHSS programmes is shared. It is the source of supporting materials for the framework for managing EHSS such as the policy, standards and guidelines and for training materials and other documents about EHSS. myEHSS is also the basis for the information system with which we collect the data for measuring our EHSS performance and reporting results within GSK and to our external stakeholders. GSK sites use the data to manage their EHSS programmes and risks and to measure their progress.
Publications Our EHSS publications are available electronically and in print. We publish articles on environment, health, safety and sustainability in Spirit, our internal magazine and brief news stories on internal web pages.
Events Our sites participate in Earthweek, an annual, voluntary programme to raise awareness of strategic environmental issues and to encourage integrating environmental concerns into the culture. Held in June to coincide with the World Environment Day, Earthweek encourages employees to think about their impact on the environment. In 2008, over 13,000 employees from 48 sites in 24 countries took part in Earthweek. We sent information kits to all sites to help them develop their own activities including tree planting, clearing litter from a local forest and involving local school children in drawing competitions with an environmental theme. In 2009, operations will be encouraged to continue their voluntary environmental activities but they will no longer be organised centrally.
Awards The CEO¶s EHS Excellence Award website was a vehicle for sharing the innovative EHS practices of sites or teams that won the annual awards. In 2009 this will be replaced by the website supporting the CEO¶s Awards for Sustainability.
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Home Responsibility Environmental sustainability Managing EHS and sustainability Audits and compliance
Corporate Responsibility Report 2008 Audits and compliance Approach
Performance
We regularly audit our operations, contract manufacturers and key suppliers to assess systems to manage risks and impacts, compliance with legislation and implementation of our environment, health, safety and sustainability standards. Audits also assess whether appropriate management systems are in place to improve performance and maintain compliance. Our internal auditors are certified as lead auditors against the ISO 14001 and OHSAS 18001 standards. All GSK manufacturing and R&D sites are audited at least once every four years. The actual frequency is determined by the level of risk and impacts and a site¶s performance at managing those risks. In 2008, we audited 31 sites. In 2006, we began a four-year programme to certify all GSK pharmaceutical and consumer healthcare manufacturing sites to the international environmental standard ISO 14001 and the health and safety standard OHSAS 18001. In 2008, we certified three more sites, bringing the total to 38 per cent of our pharmaceutical and consumer healthcare manufacturing sites certified to ISO 14001. Back to top
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Home Responsibility Environmental sustainability Managing EHS and sustainability Audits & compliance performance
Corporate Responsibility Report 2008 Audits and compliance Approach
Performance
In 2008, we audited 31 GSK sites for implementation of our EHS standards and conducted follow up visits for 17 more. The average score was 78 per cent, the same as 2007. The lowest score we consider to be acceptable is 50 per cent. No site scored below this level with the lowest score at 62 per cent in 2008. Two sites achieved µleadership¶ scores above 90 per cent (three in 2007), while a further 11 achieved scores of at least 80 per cent (14 in 2007). High audit scores indicate good management systems and work practices. Sites that achieve audit scores of 90 per cent or higher are considered to be in a leadership category and receive certificates signed by the Chief Executive Officer. Sites that achieve 80 to 89 per cent receive certificates of achievement signed by their business heads. There were no critical findings related to the environment. These are findings that indicate a high probability of incidents with potentially serious consequences. There were two critical findings related to health and safety. Read about our performance on health and safety issues. The best performance on environmental issues was in waste and water management and sites were generally weakest on assessment of risks for environment, health and safety. Twenty-six of our 78 Pharmaceuticals and Consumer Healthcare manufacturing sites are now certified to both the ISO 14001 and OHSAS 18001 standards (a further four are certified to ISO 14001 only). One Consumer Healthcare R&D site is certified to both standards and one GSK vaccines site and one Pharmaceuticals R&D site are certified to ISO 14001. A further five sites are confirmed for certification audits in early 2009. The certified sites are in Argentina, Australia, Brazil, China, Egypt, France, Germany, India, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Saudi Arabia, Spain, Turkey, the US and the UK. ISO certification is important because it indicates good management systems in place, and sites that have been successfully certified have found the experience beneficial. In order to achieve our 2010 target to certify all pharmaceutical and consumer healthcare manufacturing facilities, we will upgrade the level of management systems implementation. At the same time we will embark on the planned expansion of ISO certification into R&D and vaccines facilities.
Compliance There were no environmental fines or penalties in 2008, continuing our compliance record from 2006 and 2007. However, we remain vigilant to stay in full compliance with all environmental laws and regulations. Back to top
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Home Responsibility Environmental sustainability Managing EHS and sustainability Reward and recognition
Corporate Responsibility Report 2008 Reward and recognition The CEO¶s EHS Excellence Awards recognise and reward GSK sites that show leadership in EHS and sustainability. They highlight innovation and examples of good practice in EHSS management to share with other sites. Each winner receives a trophy and selects a charity to receive a donation from GSK Both individuals and teams can enter the competition. A shortlist is drawn up by an internal review committee and winners are chosen by a panel that includes experts from academia, government and public interest groups. Awards are divided into three categories: Green Chemistry/Green Technology ± for projects that benefit environment, health and safety through new and efficient chemistry or technology Environmental Initiative ± for programmes that demonstrate improvements in environmental management or performance Occupational Health & Safety Initiatives ± for programmes that demonstrate improvements in health and safety management and performance In 2008 ± the seventh year of the awards ± there were 89 entries from 23 countries and from all GSK businesses. Honours went to eleven projects from Australia, Belgium, India, the UK and the US. Read about winning environmental projects throughout this section and about winning health and safety projects in Our People section. In 2009, the awards will be upgraded to the CEO¶s Awards for Sustainability with new categories and new judging criteria supporting increasing focus on sustainability. Back to top
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Home Responsibility Environmental sustainability Managing EHS and sustainability Management of EHSS
Corporate Responsibility Report 2008 Management of EHSS Overall responsibility for environment, health, safety and sustainability issues rests with the Corporate Executive Team and the Board. The Chief Executive Officer represents these issues on the Board. The Board Chairman is the champion for GSK¶s climate change programme. The Chief of Staff has operational management responsibility for EHSS on the Corporate Executive Team. The Vice President, Corporate Environment, Health, Safety and Sustainability (CEHSS) has operational responsibility for EHSS, reports directly to the Chief of Staff and has a dotted line reporting relationship to the President of Global Manufacturing and Supply. Environment, health, safety and sustainability activities are overseen by the Risk Oversight and Compliance Council, the Corporate Executive Team and the Audit and Corporate Responsibility Committees of the Board of Directors. These committees regularly review EHSS performance, progress toward meeting EHSS targets and results of EHSS audits of GSK operations and suppliers. They consider issues such as sustainability that have social implications.
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Home Responsibility Environmental sustainability (QYLURQPHQWDOIXQGDPHQWDOV
Corporate Responsibility Report 2008 Environmental fundamentals We have been working to reduce the fundamental environmental impacts of our operations for many years. This involves using treatment and disposal systems to control emissions and wastes from over 80 manufacturing facilities, more than 20 research laboratories, numerous offices and warehouses and a large fleet of vehicles. Our fundamental emissions include: Wastewater General solid and hazardous waste Ozone depleting substances released from our equipment and production processes and when patients use our inhaler products Volatile organic compounds, primarily solvents We aim to create a culture where fundamental environmental considerations are part of everyday business decisions. While we continue to manage fundamental emissions, we are now moving towards sustainability, changing our production and business processes to avoid waste at source rather than simply treating the waste and emissions that arise. Back to top
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Home Responsibility Environmental sustainability Environmental fundamentals Wastewater
Corporate Responsibility Report 2008 Wastewater Approach
Performance
Most GSK sites discharge wastewater to municipal treatment facilities. Some large sites, especially the sites that manufacture active pharmaceutical ingredients (API), have their own on-site wastewater treatment systems. Some sites are permitted to discharge wastewater direct to the sea. We assess the quality of wastewater by measuring the chemical oxygen demand (COD) ± the oxygen required to chemically oxidise compounds in the water. The lower the COD, the cleaner the water. Our target from 2006 is to improve COD levels by three per cent a year per unit of sales which will give us a reduction of 12 per cent by the end of 2010. The vast majority of COD comes from manufacturing of API. Therefore wastewater from µdomestic¶ activities such as washrooms and canteens is only included when it cannot be separated from manufacturing activities.
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Home Responsibility Environmental sustainability Environmental fundamentals Wastewater
Corporate Responsibility Report 2008 Wastewater Approach
Performance
Chemical oxygen demand of wastewater
Targets and performance normalised by sales are based on a constant exchange rate. Any errors found in data from prior years are corrected so data may vary slightly from earlier reports In 2008 our chemical oxygen demand per million sales corrected to a constant exchange rate (CER) decreased 5.7 per cent from a 2006 baseline. Absolute chemical oxygen demand decreased 6.5 per cent from a 2006 baseline to 14.9 million kilograms. This decrease is in line with the target to decrease three per cent per year. Explanation for trend The quality of wastewater discharged is closely related to the types and amount of materials produced in the manufacture of our active pharmaceutical ingredient. Chemical oxygen demand of wastewater decreased significantly in 2007 with the decrease in production of antibiotic ingredients for that year. In 2008 production of these products increased so chemical oxygen demand increased, although it was still less than in 2006. The site that increased antibiotic production accounts for 21 per cent of the wastewater volume and 55 per cent of the wastewater COD. We are concerned about the level of pollution in our wastewater because it can cause a burden to local municipal wastewater treatment facilities or to local receiving water bodies. The changes in levels of wastewater pollution from year to year are due to changes in production, waste minimisation and continued improvements in wastewater treatment. For example, we are evaluating wastewater treatment technologies at our pharmaceutical ingredient manufacturing plant in Singapore and we are planning a reverse osmosis system in our pharmaceutical ingredient manufacturing plant in India. In addition, our work to improve manufacturing efficiency should decrease wastewater pollution in the future. We generated 10.8 million cubic metres of wastewater in 2008 as compared to 10.9 million cubic metres in 2007. The volume of wastewater in 2008 was 1.3 per cent lower than 2007 and 8.1 per cent lower than the 2006 baseline.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Environmental fundamentals Waste
Corporate Responsibility Report 2008 Hazardous and non-hazardous waste Approach
Performance
Our production, research and sales activities all produce waste: Production ± hazardous wastes such as solvents and other chemicals R&D and quality control laboratories ± small amounts of chemicals including products and intermediates, as well as broken glassware and plastics Offices ± paper and other standard commercial waste Building renovations produce non-routine waste such as obsolete equipment, office furniture and structural materials We classify waste as hazardous, non-hazardous, and non-routine (for waste such as construction and demolition rubble). A significant proportion of our waste is classified as hazardous because it contains solvents and chemicals used to manufacture active pharmaceutical ingredients. Other hazardous waste we produce includes lubricants, fluorescent lights and carcasses of animals used in research. Most nonhazardous waste is general material such as office waste paper, kitchen waste and non-hazardous substances used in manufacturing.
Our approach We aim to eliminate waste where we can, reduce it if we cannot eliminate it, reuse materials if possible, recycle other waste and dispose of any remaining material sensitively. We separate hazardous wastes into different categories for efficient and appropriate treatment. Regulations vary widely around the world, but our first choice for solvents, which account for most of our hazardous waste, is to reuse or recycle them. Some used solvent is recovered and purified on site and reused in the original manufacturing process and some is sold to commercial reprocessing companies but is still included in our recycling statistics. When reuse or recycling is not possible, solvents are mostly incinerated and the energy recovered wherever possible. We require disposal contractors to comply with our EHS requirements and local regulations. Sites audit their waste contractors or hire consultants to carry out the audits. Our target is to reduce non-hazardous waste disposed per unit of sales by one per cent per annum which will give us a reduction of four per cent by the end of 2010. We have not set a target for reduction of hazardous waste but our target to improve material efficiency, the efficiency with which we convert raw materials to finished products, is designed to reduce hazardous waste. The amount of non-hazardous waste disposed is affected by many factors. The amounts and types of products made in a year can affect not only the amount of waste but also the ability to recycle. In addition to production changes, some sites are actively and aggressively working to recycle as much waste as possible and decrease disposal of waste to minimum levels with focus on eliminating waste sent to landfill. Disposal of hazardous waste is affected by the way solvents are managed and by the mix of products that are made in the year. Most hazardous waste comes from manufacture of active pharmaceutical ingredients, and this is where we concentrate our efforts. We do not collect hazardous waste data from consumer manufacturing plants, laboratories and offices. We estimate that these sites may generate an additional three per cent of hazardous waste to the amount we report.
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SGS verified Building trust through environmental commitment
In 2008, our manufacturing site in Boronia, Australia, stepped up its environmental efforts. CEO Andrew Witty recognised the site¶s achievements by awarding it first prize in the environment initiative category of his 2008 Environment, Health and Safety Excellence Awards. Achievements include: Establishing a µgreen team¶ of employee volunteers that has helped to increase involvement in sustainability activities. As a result the site has reduced water use by 20 per cent from 2007 levels, energy use by 5 per cent from 2007 levels and waste, with 34 tonnes diverted from landfill A 96 per cent reduction in CO 2 emissions from product transport, the result of switching from air freight to sea freight for imports of raw materials and exports of finished goods. This also saved the facility an estimated $A2.9 million (1.3 million GBP) in 2008 and we anticipate these savings will increase to over $A4 million (1.8 million GBP) annually from 2009 onwards Introduction of waste-saving measures to the cold chain distribution system, including reusable cool boxes, data loggers and ice bricks. The new cold chain system manages temperature better, even in extreme conditions. This has prevented 12,000 polystyrene cool boxes and temperature alert tags, and 50,000 disposable ice bricks from being sent to landfill. It also saves our customers the trouble of waste disposal ± all they have to do is repack the equipment and we collect it from them This project won first place in the 2008 CEO¶s EHS Excellence Awards, Initiative-Environment category.
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Home Responsibility Environmental sustainability Environmental fundamentals Waste
Corporate Responsibility Report 2008 Hazardous and non-hazardous waste Approach
Performance
Non-hazardous waste Non-hazardous waste disposed
Targets and performance normalised by sales are based on a constant exchange rate. Any errors found in data from prior years are corrected so data may vary slightly from earlier reports Destination of non-hazardous waste 2008
Targets and performance normalised by sales are based on a constant exchange rate. In 2008 the amount of non-hazardous waste disposed per million sales corrected to a constant exchange rate (CER) decreased 8.5 per cent from a 2006 baseline. Absolute non-hazardous waste decreased 9.2 per cent from a 2006 baseline to 32.9 million kilograms. This is significantly better than the one per cent per year improvement target. Explanation for trend In 2008 the decrease in non-hazardous waste disposed is at least partially due to continuing efforts to
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
manage and recycle waste especially in the pharmaceutical and consumer manufacturing operations. It is also due in part to decreased production of some products. This is partially balanced by increasing waste in the vaccines business as it continues to grow. Our target is specific to non-hazardous waste disposed but we also measure total non-hazardous waste generated which includes both non-hazardous waste disposed and non-hazardous waste recycled. In 2008, we generated 109.4 million kilograms of non-hazardous waste, compared to 120.3 million kilograms in 2007 and 114.7 million kilograms in 2006. Of this, 70 per cent was recycled and 30 per cent was disposed of via landfill or incineration. We reduced disposal of non-hazardous waste at our pharmaceutical manufacturing sites by 22.1 per cent and by 17.9 per cent at our pharmaceutical R&D sites from 2006. However there was a 72.9 per cent increase in non-hazardous waste disposal in our vaccines business due to continuing expansion. This resulted in the overall 9.2 per cent decrease in the amount of non-hazardous waste disposed in GSK compared to the 2006 baseline. We have met our non-hazardous waste improvement target. However, to ensure that we maintain this improvement during times of production increases we will review improvement projects to make sure we continue to reduce the amount of waste we dispose. We are particularly committed to reducing the amount of waste sent to landfill because we want to minimise this burden on the environment and society as landfill space becomes harder to find and the cost of sending waste to landfill increases. These data do not include non-routine waste such as construction and demolition rubble and similar material not related to day-to-day operations. We continue to look for ways to reduce waste and have undertaken waste management reviews at many sites. Recycling non-hazardous waste such as paper, cardboard, glass, plastic or aluminium usually means sending it for reprocessing so it can be reused to make new products. In addition to these waste reduction measures, the reductions are likely to be due to decreases in the volume of production of certain pharmaceutical and consumer healthcare products. As examples of projects that have reduced non-hazardous waste disposal, two sites in India have stopped putting the coal ash they generate into landfill; instead they sell it as raw material for the production of construction material. In addition, three nutritional drink manufacturing sites send some of their process wastes, such as barley husk, for use in animal food while others recycle canteen waste or effluent treatment plant sludge by converting it into bio-compost.
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Hazardous waste Hazardous waste disposed
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Targets and performance normalised by sales are based on a constant exchange rate. Any errors found in data from prior years are corrected so data may vary slightly from earlier reports Destination of hazardous waste 2008
Any errors found in data from prior years are corrected so data may vary slightly from earlier reports In 2008 the amount of hazardous waste disposed per million sales corrected to a constant exchange rate (CER) decreased 22.1 per cent from a 2006 baseline. Absolute hazardous waste decreased 22.7 per cent from a 2006 baseline to 54.4 million kilograms. Explanation for trend The decrease in hazardous waste disposed from 2006 to 2008 was due to continued efforts to manage and recycle hazardous waste, especially solvents. It is also due in part to decreased production of some products that used significant quantities of solvent and to outsourcing some production. The amount of hazardous waste disposed is related to the types and quantities of products made and the amount of solvent used by our factories that manufacture active pharmaceutical ingredients. Solvent waste is 92.4 per cent of hazardous waste generated and 98.6 per cent of hazardous waste recycled. The four largest sites that manufacture active pharmaceutical ingredients together account for over 74 per cent of the solvent waste disposed. We did not set a target for reducing hazardous waste disposed. Instead we focused our attention on improving manufacturing efficiency because efficiency improvements will mean less material used in the manufacturing process and therefore less waste. However, efficiency improvements will take some time to achieve. In the meantime, because it is important to minimise hazardous waste, we monitor this and improve the way we handle it, for example by recycling solvents.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Environmental fundamentals Contaminated land
Corporate Responsibility Report 2008 Contaminated land Handling practices for some chemicals, used by industries in the past and now no longer followed, caused contamination to land and groundwater. Land can also become contaminated due to accidental release of materials. We are involved in a number of projects in the UK and the US to remediate sites with contaminated land. We have identified five sites in the UK that require some remediation and more than 50 sites in the US. We work with governments and other parties to effect any necessary remediation. Costs of remediation are shared between the parties involved. The five UK sites are undergoing remediation and two are being partially or fully decommissioned. GSK and its heritage companies have spent more than 100 million cleaning up more than 50 sites in the US over the last 20 years. We are continuing to clean up 25 of these sites. Most of them are waste disposal sites where GSK is one of several responsible parties. These figures are not included in the data verification. Explanation for trend When the heritage companies that formed GSK were confronted with a number of contaminated land sites we undertook actions to avoid similar problems occurring in the future. The first action was to audit commercial hazardous waste treatment and disposal sites for their level of performance and financial solvency to avoid inappropriate disposal. The second action was to minimise solvent use wherever possible as we did by changing from solvent coating to aqueous coating of tablets. The third action was to initiate a project to improve material efficiency and to minimise or eliminate hazardous (persistent, bioaccumulative and toxic) compounds. We have also reviewed production operations to determine if past practices have contaminated soil or ground water. Where problems were discovered we initiated site remediation.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Environmental fundamentals Emissions to air
Corporate Responsibility Report 2008 Emissions to air Approach
Performance & plans
Ozone depletion The ozone layer in the upper atmosphere is essential to human survival because it filters out harmful ultraviolet rays from the sun. It has been damaged by ozone depleting substances (ODSs), mainly chlorofluorocarbons (CFCs), hydrochlorofluorocarbons (HCFCs) and halons. The loss of ozone in the upper atmosphere means that more ultraviolet-B radiation reaches the earth¶s surface. This can affect health, for example by causing skin cancer, skin ageing, eye disorders and suppression of the immune system. Industrial use of ODSs was common before their negative effects were realised. In the past, we used CFCs as the propellant gas in most of our metered dose inhalers (MDIs). These deliver a precise dose of medication to treat asthma sufferers and people with chronic obstructive pulmonary disease. The gas is released when patients use the inhalers and a small amount escapes during production. The Montreal Protocol bans the production of CFCs, but it exempts a number of µessential uses¶ which include MDIs. However, in support of its principles we plan to eliminate the use of CFCs from our products by the end of 2010. Less than two per cent of our inhalers now contain CFCs. We have stopped using CFCs as propellants in inhalers made in the US and the European Union. We offer a selection of alternatives in most other countries and will eliminate all CFCs from our products worldwide by the end of 2010. The main alternative propellant used is HFA 134a, a hydrofluoroalkane. This does not affect the ozone layer but does have global warming potential, although significantly lower than CFC, contributing to climate change. We have also invested heavily in dry powder delivery systems that do not use propellants such as CFCs or HFA 134a. These are not suitable for all patients, particularly children and the elderly, as they do not contain propellants and rely on a person¶s lung power for the active ingredients to be administered.
Equipment and production We also use ODSs in some cooling systems and for other ancillary uses at GSK facilities. These are contained inside the systems and are only released in the event of a leak or during maintenance. We have switched to using hydrofluorocarbons (HFCs), ammonia and hydrocarbons. Ammonia does not contribute to either ozone depletion or climate change and hydrocarbons have a small climate change impact. We aim to eliminate CFCs and HCFCs from cooling systems. This is the only way to completely eliminate emissions from equipment. We are focusing on removing larger pieces of equipment from service before the end of 2010. We do not intend to replace equipment containing less than one kilogram of CFCs or HCFCs prior to their planned replacement. This type of equipment tends to be hermetically sealed and is less likely to leak.
Volatile organic compounds Volatile organic compounds (VOCs) react with nitrogen oxides in the presence of sunlight, creating ozone in the lower atmosphere. This results in smog which is a factor in human respiratory illness. Workplace exposure to certain VOCs can also pose a health risk.
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We emit VOCs to the atmosphere mainly from solvents used in our primary manufacturing operations and R&D pilot plants. Solvents are also used to coat some tablets and in cleaning for sterile operations. We use small quantities of solvents in laboratories but do not measure emissions from this use. Our target is to reduce volatile organic compound emissions to air by two per cent per year per unit of sales which will give us a reduction of 8 per cent by the end of 2010.
SGS verified
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Environmental fundamentals Emissions to air
Corporate Responsibility Report 2008 Emissions to air Approach
Performance & plans
Ozone depletion Ozone depletion potential (CFC-11 equivalents)
Targets and performance normalised by sales are based on a constant exchange rate Any errors found in data from prior years are corrected so data may vary slightly from earlier reports CFC-11 has an ozone depletion potential of 1 In 2008 we reviewed the refrigeration equipment inventories for 2006, 2007 and 2008. Where inventories were incomplete they were estimated based on inventories in other years. We also updated the factors for ozone depletion potential and climate change emissions using WMO (World Meteorological Organisation), Scientific Assessment of Ozone Depletion: 2006, Global Ozone Research and Monitoring Project²Report No. 50, 572 pp., Geneva, Switzerland, 2007. (chapter 8). In 2008, estimated ozone depletion potential (ODP) from equipment and production losses per million sales corrected to a constant exchange rate (CER) decreased 82.3 per cent from a 2006 baseline. Absolute ODP from equipment and production losses decreased 82.4 per cent to 5.8 thousand kilograms. This indicates significant progress towards our target to eliminate losses of CFCs and HCFCs from production and equipment. Explanation for trend In 2008, 5.4 thousand kilograms of ozone depleting substance were released during production of inhalers and we estimate that less than one thousand kilograms of CFC-11 equivalent were emitted from equipment. In 2008, 87.7 thousand kilograms of CFC propellant were released when patients used our products. Ozone depletion potential from patient use of metered dose inhalers was 51.9 per cent lower than in 2006. As production of CFC-containing MDIs decreases, the amount of CFC lost during production also declines We maintain a register of the significant pieces of equipment that contain refrigerants and use this register to track progress towards the target to eliminate CFCs and HCFCs from refrigeration equipment. We have 162 pieces of equipment containing CFCs, amounting to 10,238 kilograms in total. Over 6,774 items of
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p q p g g g equipment contain other ODSs, with an ODP of 16,468 kilograms of CFC-11 equivalent. We estimate (using an estimation factor of 2.75 per cent from the British Refrigeration Association) that 468 kilograms CFC -11 equivalent were released from equipment in 2008. We are making progress towards our target and expect that we will achieve it.
SGS verified
Volatile organic compounds Volatile organic compound emissions
Targets and performance normalised by sales are based on a constant exchange rate Any errors found in data from prior years are corrected so data may vary slightly from earlier reports In 2008 the amount of volatile organic compound released to air per million sales corrected to a constant exchange rate (CER) decreased 9.7 per cent from a 2006 baseline. Absolute volatile organic compound emissions decreased 10.4 per cent from a 2006 baseline to 3.9 million kilograms. This is better than our two per cent per year target. Explanation for trend Emissions of VOC to air are affected by the management of solvents and by the mix of products that are made in the year. In 2008 we decreased production of several products that used significant quantities of solvent and we outsourced several steps of one product. It is important to reduce emissions of VOC because it benefits the environment, society and GSK. We want to reduce these emissions even in high production years so we continue to identify projects to reduce emissions. In 2008 one site installed a carbon absorption unit to reduce emission of solvents and two more sites have emission reduction projects planned for 2009. We anticipate achieving our target.
Our plans Our material efficiency projects are expected to reduce the amount of solvent used and we should see the effects of this work in reduced solvent emissions in the future. In the meantime we continue to look for ways to reduce solvent use and increase recycling to achieve our target of a two per cent annual reduction in emissions resulting in eight per cent improvement by the end of 2010. Two of our sites that manufacture active pharmaceutical ingredients have projects planned for 2009 to control emissions.
SGS verified
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Environmental fundamentals EHSS in business processes
Corporate Responsibility Report 2008 EHSS in business processes Here we describe how we are embedding environment, health, safety and sustainability (EHSS) principles into our business processes.
New product development and supply Our EHSS Milestone Aligned Process helps scientists identify and address environment, health, safety and sustainability issues during new product development and supply activities. It ensures that: Scientists understand environment, health, safety and sustainability impacts and how they should be managed throughout a product¶s life-cycle New products and processes are developed that do not harm people, property or the environment Opportunities are identified, such as process efficiencies and elimination of waste that reduce environment, health, safety and sustainability impacts and improve product development and supply
Acquisitions and divestitures Our due diligence process for acquiring and divesting businesses ensures that environment, health, safety and sustainability issues are considered in contract negotiations and that adequate management systems are in place. We work with acquired companies to develop action plans to align their EHSS practices with GSK¶V
Emergency response and crisis management The discovery, development and manufacture of pharmaceutical and consumer products involve the use of hazardous materials and processes. All sites incorporate emergency response and crisis management programmes into their management plans. These programmes ensure that accidents are effectively managed when they occur and that any impact on our business, the local community and the environment are minimised. Each site conducts an annual review of its internal emergency response programmes and technical capabilities and develops action plans to address any areas needing improvement.
Procurement Our procurement activities support our environment, health, safety and sustainability (EHSS) goals in the following areas: Sourcing renewable and recycled materials where appropriate Choosing safe and energy-efficient equipment Managing EHSS risks in our supply chain Our capital project technical review process ensures that we consider environment, health, safety, security and loss prevention in the design of new facilities and processes. By identifying EHSS issues early in a project, we can engineer facilities and processes that are efficient and safe for workers and the environment while still being cost effective. Read more about EHS and procurement. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Environmental fundamentals Supplier performance
Corporate Responsibility Report 2008 Supplier performance We want to understand the total environmental footprint of the processes used to make our products. This means measuring the impacts of our suppliers of active pharmaceutical ingredients and packaged products, as well as those from our own operations. Some of our improvements in hazardous waste and air emissions were due to outsourcing of some production processes. Until we can collect data from our suppliers we will not know the full impact of production of our products. In the future we hope to report on the combined environmental impacts of manufacturing at GSK facilities and at our contract manufacturers. GSK selects suppliers with an appropriate level of EHS management systems control. However, over the past few years it has proved difficult to obtain environment, health and safety performance data from these suppliers just for the products that they manufacture for GSK. In 2007 we surveyed 52 suppliers and received a response from 21 (40 per cent). They indicated that they preferred providing data after the first quarter of the year to give them time to review it. With this input from our suppliers we changed our process. For energy data we will join the Carbon Disclosure Project (CDP) supplier initiative and request energy and climate change data from our large suppliers through the CDP. We will collect 2008 water, waste and injury and illness data from suppliers during the second quarter of 2009 using our electronic system. We published the 2007 data in our 2007 corporate responsibility report and will publish 2008 data in the 2009 report. Read more about GSK¶s supply chain.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Sustainability
Corporate Responsibility Report 2008 Sustainability Traditional environmental programmes focus on managing wastes after they are generated by business processes. Sustainable practices change the business processes themselves to consume less natural resource, switch to renewable materials, protect biodiversity, generate less waste, eliminate waste that is persistent, toxic or bioaccumulative and lower costs. This approach benefits the environment, society, GSK and future generations. Our high priority sustainability issues are: Manufacturing efficiency ± reducing the amount of raw materials needed to produce a finished product Climate change ± reducing the climate impacts of our buildings, equipment, transport and products Water ± reducing the amount of water we use Product stewardship ± reducing the use of materials of concern and the environmental impacts of our products after use by the patient Packaging ± reducing the amount of packaging we use and using recyclable and recycled materials Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Sustainability Materials efficiency
Corporate Responsibility Report 2008 Materials efficiency Approach
Performance
We aim to increase the efficiency with which we convert raw materials to finished products. Known as materials efficiency, this helps reduce the resources we use, the waste we generate and the cost of production. Pharmaceutical processes are often complex, usually requiring large amounts of solvents and other raw materials. Typically, the industry uses more than 100 tonnes of material for every tonne of active pharmaceutical ingredient (API) produced. We have set a target to double the average materials efficiency of manufacturing processes for new products introduced between 2006 and 2010.
Process design Process design is essential to minimising environmental impacts. It determines which chemicals and processes are used in manufacturing as well as the impacts from production waste. The EHS team works with process development teams to incorporate EHS considerations into process design and materials sourcing, and to identify potential EHS risks in manufacturing. New manufacturing technique cuts energy and waste
Our R&D facility in North Carolina has developed a novel way to manufacture a diabetes drug, currently in phase ll clinical trials, cutting environmental impacts and costs. This replaces a production method that was too resource-intensive to use on a large scale. The chemical development department found a way to synthesise the molecule more efficiently and then produce it at a yield 37 per cent greater than before. The new process uses fewer raw materials, less than half the energy and 81 per cent less solvent. It also produces around 30 per cent less wastewater. The new process will save over 110 million each year in raw material and waste disposal costs. This project won first place in the 2008 CEO¶s EHS Excellence Awards, Green Chemistry and Technology category
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Sustainability Materials efficiency
Corporate Responsibility Report 2008 Materials efficiency Approach
Performance
Mass productivity
The chart shows how we improve materials efficiency as compounds move through development stages. In the early stages almost all compounds are less that one per cent materials efficient. By the last stage most achieve more than two per cent and some are above three per cent, with one process achieving productivity of 4.9 per cent. Explanation for trend Improving manufacturing efficiency is one of the most important ways we can address sustainability and meet some of our fundamental environmental targets such as reducing our disposal of waste and emissions to air. This will not be easy because the chemical processes that make our medicines can be complex. In spite of the difficulties, we remain committed to improving efficiency for new products. In 2009 we will review the production processes that are transferred to manufacturing to determine if additional improvements are possible so that we can achieve our target.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Sustainability Climate change and energy
Corporate Responsibility Report 2008 Climate change and energy Approach
Performance & plans
It is widely acknowledged that human activity, primarily burning fossil fuels to produce energy, is contributing to climate change. The Intergovernmental Panel on Climate Change (IPCC), the world¶s leading climate authority, has stated that urgent action is needed to avoid the effects of dangerous climate change, including more frequent extreme weather events such as droughts, floods and hurricanes. We want to be part of the solution to climate change and are committed to reducing our impact. As well as benefiting the environment, taking action on climate change helps us cut costs, improves our reputation with stakeholders and helps us prepare for future legislation on emissions. Read about our energy and climate change position
Our climate change programme In 2007, following the fourth assessment report of the Intergovernmental Panel on Climate Change, we launched a new climate change programme and committed to new targets. This includes a commitment to reducing our climate change impact (CO 2 equivalent emissions) and energy use in operations and transport from 2006 levels by 20 per cent per unit of sales (based on a constant exchange rate) by 2010 and by 45 per cent by 2015. This replaced our 2006 target to reduce energy use by one per cent per year, normalised by sales. We will achieve our new targets by: Making our buildings and equipment more energy efficient Installing onsite renewable technologies such as wind turbines and photovoltaic panels Buying electricity produced from renewable sources Reducing the climate impact of travel and transport by switching from air to sea freight and by transporting more per load to reduce the number of journeys needed The Corporate Executive Team has approved a central fund to help finance these energy saving projects. The Climate Change and Energy Reduction team consulted with GSK businesses to identify potential energy saving projects. In 2008, 171 projects were completed which are expected to result in a saving of more than 153,000 Kwh (550,800 GJ) of energy per year and more than 40 thousand tonnes of climate change emissions. Product climate impact We are also researching ways to minimise the amount of greenhouse gases released when our propellant inhaler products are used by patients for asthma and chronic obstructive pulmonary disease. These account for two-thirds of our climate impact. Propellant inhalers contain either hydrofluoroalkanes (HFAs) or chlorofluorocarbons (CFCs) which ensure a consistent dose but HFAs are 1,400 times more damaging to the climate than CO2 and some CFCs are more than 10,000 times more damaging to the climate than CO2. CFCs also deplete the ozone layer.
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SGS assurance logo Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Sustainability Climate change and energy Performance and plans
Corporate Responsibility Report 2008 Climate change and energy Approach
Performance & plans
GSK¶s carbon footprint
Other includes climate change impact from greenhouse gases released from cooling systems, during the production of inhaler products, from wastewater treatment and other processes. Any errors found in data from prior years are corrected so data may vary slightly from earlier reports Climate change impact from operations energy and transport
Targets and performance normalised by sales are based on a constant exchange rate
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Any errors found in data from prior years are corrected so data may vary slightly from earlier reports We use the Greenhouse Gas Protocol for all of our calculations of CO 2 emissions from energy use. We also updated the factors for climate change emissions from propellants and refrigerants using WMO (World Meteorological Organisation), Scientific Assessment of Ozone Depletion: 2006, Global Ozone Research and Monitoring Project²Report No. 50, 572 pp., Geneva, Switzerland, 2007. (chapter 8) In 2008, our carbon footprint was equivalent to 7.0 million tonnes of CO 2 compared to 7.3 million tonnes in 2006. The majority of our emissions come from the use of inhalers by patients with respiratory disease. A decrease in the use of CFC inhalers with a simultaneous increase in the use of HFA inhalers meant that our climate change emissions from patient use of inhalers did not change significantly from 2006 to 2008, remaining at 4.7 million metric tonnes of CO 2. If we exclude the use of inhalers, our carbon footprint reduced from 2.6 million tonnes of CO 2 in 2006 to 2.4 million tonnes in 2008, reflecting emissions of greenhouse gas from inhaler manufacturing which decreased from 0.5 million tonnes in 2006 to 0.3 million tonnes in 2008. Explanation for trend We recognise that our products have more of a climate change impact than our energy consumption so our R&D scientists are working to develop alternatives to HFA as a propellant for all candidate inhaled products.
Emissions from operations energy and transport Our CO 2 emissions from operations energy and transport per million sales corrected to a constant exchange rate increased 1.6 per cent from a 2006 baseline. Absolute climate change emissions increased less than 1 per cent from a 2006 baseline to 2.1 million tonnes. This was due to increased energy use in the growing vaccines business which overshadowed the energy savings in our pharmaceutical and consumer manufacturing operations, and to an increase in the use of coal in India. Our energy use from operations and transport on which these CO 2 emissions are based, decreased less than one per cent from 2006 to 2008 to 24.3 million gigajoules.
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Energy performance Energy consumption (facilities and processes)
Targets and performance normalised by sales are based on a constant exchange rate Any errors found in data from prior years are corrected so data may vary slightly from earlier reports
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Seventy-nine per cent of our energy use is attributed to energy for operations (facilities and processes). In 2008 our energy use per million sales corrected to a constant exchange rate (CER) increased less than one per cent from a 2006 baseline. Absolute energy use decreased less than one per cent from a 2006 baseline to 19.2 million gigajoules. This is equivalent to the energy used by over 200,000 UK households. Explanation for trend We set aggressive targets to reduce energy use and related climate change emissions and are moving towards these although progress is slower than expected. If we continue on the present course we expect to achieve an improvement of eight per cent per unit sales by 2010. We have taken steps to accelerate the implementation of energy reduction projects such as diverting more engineering resources to support them. We also expect projects initiated in 2008 will begin to deliver energy and carbon savings in 2009 that will then be sustained. In addition, business changes such as site closures resulting in more efficient use of existing facilities may help us achieve the target. We therefore remain committed to the 2015 target of a 45 per cent improvement. Energy use decreased more than four per cent in the pharmaceutical and consumer manufacturing organisation and the pharmaceutical R&D organisation. However it increased more than 30 per cent in the vaccines organisation due to continuing growth with additional and enlarged buildings and new products. Our pharmaceutical and consumer manufacturing, our vaccines manufacturing and research group and our pharmaceuticals R&D group accounted for 54 per cent, 15 per cent, and 25 per cent of energy use respectively. Between 2001 and 2006 our energy efficiency programme achieved incremental gains in energy efficiency by focusing on operational changes. These included optimisation of equipment use, resetting thermostats and changing to energy efficient lighting. Since 2006, some parts of our business continued to make incremental gains in energy efficiency but growth in our vaccines business and the associated increases in energy use partially offset these efficiency gains. In mid-2007 we revised our climate change programme to include more challenging targets covering energy for operations (facilities and processes) and transport of products and employees. A fund was set up to encourage energy projects. More than 400 potential projects were identified for support from this fund in 2007 and in 2008 171 projects were completed with more than 15 million spent. These projects are expected to save 153 million kilowatt hours of energy and 40 thousand metric tonnes of climate change emissions. The majority of projects were completed towards the end of 2008 so the full benefit of these projects will not be realised until 2009. We are currently working on a further 157 projects and a significant proportion of these will be completed during 2009. Around 75 projects that were identified for support in 2007 and 2008 were abandoned following more detailed investigations to determine their business benefit.
Our plans In 2008 GSK identified more than 600 potential projects for support from our climate change fund and our pharmaceutical and consumer healthcare manufacturing business has created a Centre of Excellence to support the implementation of these projects during 2009. In particular, emphasis will be given to implementing combined heat and power (CHP) projects. CHP is the simultaneous generation of usable heat and power, usually electricity, in a single process. Typically CHP uses a gas turbine, an engine or a steam turbine to drive an alternator to produce electricity. The heat produced is recovered, usually in a heat recovery boiler, to provide steam, hot water or even cooling with the right equipment. Because CHP systems use the heat produced during the electricity generation process, they can achieve overall efficiencies in excess of 70 per cent at the point of use. Conventional power plants have efficiencies of less than 50 per cent because the excess heat which they generate is normally wasted and additional losses occur during transmission and distribution. Another key area of focus will be to identify energy saving opportunities associated with heating, ventilation and cooling (HVAC). This equipment is needed to maintain the correct environmental conditions within our production areas so we can manufacture our products. However, it is responsible for more than 50 per cent of the operational energy that we consume. Energy reduction has also been identified as a key objective for this business and in 2009 the remuneration of senior managers will be linked to the achievement of energy reduction targets. Energy consumption has also been identified as a key business metric that will be tracked throughout 2009 by the Corporate Executive Team.
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Using canal water for sustainable cooling
In December 2008, GSK unveiled an energy-saving scheme in partnership with British Waterways, the organisation in charge of the UK¶s canal network. Under the initiative, GSK House in Brentford will use water from a nearby canal, rather than more energy-intensive air conditioning, to cool its computer data centres. This will reduce carbon dioxide emissions by around 920 tonnes per year. It will also lower energy bills by 100,000 annually, recovering the costs of the project within five years.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Sustainability Climate change and energy Climate change emissions since 1990
Corporate Responsibility Report 2008 Climate change emissions since 1990 For GSK, climate change emissions from inhaler products are significantly greater than the climate change emissions from operational energy and transport. Our climate change emissions increased 86 per cent from 1990 to 1998 as sales of inhalers with chlorofluorocarbon (CFC) propellants increased. Phase out of CFC propellants began as a result of the Montreal Protocol which aimed to eliminate ozone depleting compounds (CFCs have an impact on both ozone depletion and climate change). As these were replaced with inhalers using hydrofluoroalkane (HFA) propellants or with dry powder inhalers that do not use propellants, climate change emissions improved dramatically because HFAs have much lower climate change impact than CFCs. Currently with 98 per cent of inhalers either using HFA propellants or being dry power propellant-free inhalers, climate change emissions are 64 per cent lower than 1990 levels. These emissions are expected to grow in the coming years as sales of inhalers with HFA propellants continue to grow. The emissions from inhalers and energy back to 1990 were estimated based on energy and CFC data in public reports back to 1993 for heritage SmithKline Beecham and to 1996 for heritage GlaxoWellcome. Where actual data for inhalers and energy were not available, sales data were used with factors applied to estimate climate change emissions. Climate change emission factors for CFC and HFC have been revised over the years and we used the current factors from the World Meteorological Organisation published in 2007. Global warming potential from energy, transport and inhaler use
http://www.epa.gov/ozone/science/ods/classone.html WMO (World Meteorological Organisation), Scientific Assessment of Ozone Depletion: 2006, Global Ozone Research and Monitoring Project²Report No. 50, 572 pp., Geneva, Switzerland, 2007. (chapter 8) Explanation for trend When the Montreal protocol called for the elimination of CFCs because of their effect on the ozone layer we invested over 1 billion to develop alternatives including devices that use HFA as a replacement propellant. HFA has no ozone depleting potential and it has a lower effect on climate change than CFC. Therefore, as CFC propellants were phased out and HFA phased in, there was a significant decline in the climate change impact from products. We estimated our climate change emissions back to 1990, and calculated an improvement of over 60 per cent by 2008. This compares to the 12.5 per cent reduction that the Kyoto protocol requires for the UK from 1990 to 2012. The Kyoto protocol does not include climate change emissions for CFC but it does include HFA. Back to top
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Home Responsibility Environmental sustainability Sustainability Climate change and energy Emissions trading
Corporate Responsibility Report 2008
Emissions trading A number of our UK sites participate in the UK government¶s voluntary Climate Change Agreement programme which provides companies with energy tax rebates if they meet agreed energy-efficiency targets. In 2008 GSK reported its compliance with these agreements and all participating GSK sites were found to comply with their Climate Change Agreements. Several GSK sites participated in the European Union Emissions Trading Scheme (EU ETS). Collectively these sites emitted below their specified CO 2 allowances, generating a surplus of carbon credits. Proceeds from the sale of carbon credits are invested in energy-saving projects. Back to top
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Home Responsibility Environmental sustainability Sustainability Climate change and energy Transport impact
Corporate Responsibility Report 2008 Transport impact In 2008, we estimate that transport of our products and employees accounted for 361 million kilograms of CO 2, compared to 363 million kilograms in 2007. This was equivalent to about 17 per cent of our climate change impact from energy. Our travel-related CO 2 emissions consisted of: Business air travel (34 per cent) Global sales fleet (32 per cent) Transport of products from manufacturing plants to distributors (34 per cent), most of which was by air freight (82 per cent). Our options for reducing the impact of transporting products include: Consolidating freight shipments Reducing the number of shipping points Making more use of round tripping (managing inbound freight trucks so they do not return empty) Switching from air to sea transport where possible
Travelling to work We have µgreen travel plans¶ at a number of sites to encourage employees to reduce the environmental impact of their travel to work. For example, at GSK House in Brentford, UK, reserved parking spaces are given to car-sharers and drivers of fuel-efficient cars. We provide changing rooms and showers for cyclists, as well as discounts for bicycle equipment and repairs. At our Philadelphia office the cost of public transportation is subsidised.
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Home Responsibility Environmental sustainability Sustainability Water use
Corporate Responsibility Report 2008 Water use Approach
Performance & plans
Clean water is a valuable resource that needs to be conserved and protected from pollution. We aim to minimise the amount of water we use and the environmental impact of the water that we discharge. GSK uses water in manufacturing (for processes, products, cooling and cleaning) and for general site uses, including drinking, food services and sanitation. Sites that manufacture active pharmaceutical ingredients use large amounts of water, while R&D sites and offices use less. Our water standard requires sites to minimise water use, reuse water whenever feasible and ensure that all wastewater is treated and discharged in a way that minimises adverse environmental impacts. Our target is to reduce water consumption by two per cent per annum per unit of sales which will give us an eight per cent water saving by the end of 2010.
SGS verified
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Home Responsibility Environmental sustainability Sustainability Water use
Corporate Responsibility Report 2008 Water use Approach
Performance & plans
Water consumption
Targets and performance normalised by sales are based on a constant exchange rate Any errors found in data from prior years are corrected so data may vary slightly from earlier reports In 2008 the amount of water used per million sales corrected to a constant exchange rate (CER) decreased 10.6 per cent from a 2006 baseline. Absolute water use decreased 11.4 per cent from a 2006 baseline to 19.7 million cubic metres. This is significantly better than the two per cent per year target. Explanation for trend Most of this reduction was achieved through maintenance at facilities and process changes. Smaller improvements were achieved through ongoing conservation measures, particularly at water -stressed locations. For example, our pharmaceutical manufacturing plant in Boronia, Australia, located in a water stressed area, has an ongoing campaign to save water. Since 2001 they have reduced water usage by 33 per cent while increasing production by 22 per cent and staff by 30 per cent, saving an average of 29 million litres of water a year. These water savings are accomplished by recovering wastewater and using it in cooling towers, amenities and maintenance, by capturing storm water and by communicating with employees about saving water. We believe we will achieve our target.
Our plans GSK has endorsed the UN Global Compact¶s CEO Water Mandate. The UN estimates that more than 1 billion people do not have access to clean water and 2.6 billion people lack the basic sanitation necessary for health and well-being. Water stress is expected to worsen in many parts of the world as a result of factors including urbanization and population growth, increasing food production, changing consumption patterns, industrialization, water pollution, and climate change. We joined the mandate because we recognise that water is an important and valuable resource that needs to be managed responsibly and we are committed to taking action by developing a comprehensive approach in the six areas identified in the mandate: Direct Operations; Supply Chain and Watershed Management;
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Collective Action; Public Policy; Community Engagement; and Transparency. In many of these areas we have already taken some action. For example we have targets for water conservation and we reported water usage from our own operations. We have plans in place to collect and report water usage from a sample of key suppliers. We work with local communities to conserve water and preserve wetlands and we educate our employees in water conservation. We understand the connection between water and public health and have a philanthropic project known as PHASE to educate people in developing countries about the importance of hand washing. To meet the requirements of the Mandate we will build on these and other existing efforts and manage them under a single programme. During 2009 a Team with representatives from across the business will be formed to determine key priorities and objectives.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Sustainability Product stewardship
Corporate Responsibility Report 2008
Product stewardship We take the environment into account across the entire lifecycle of our products. This begins with process design and continues through manufacturing to use by patients and eventual disposal. Some of our wastes such as used solvents can be reused as a raw material for another industry such as paint stripping (cradle to cradle). In this section we focus on several aspects of product stewardship: Pharmaceuticals in the environment Some portion of active pharmaceutical ingredients, the substances that make medicines work, may eventually be excreted by humans and enter the environment. We conduct tests and risk assessments to evaluate the potential effects of our pharmaceutical products on the environment. Materials of concern Materials of concern are chemicals where scientific evidence shows probable serious long-term effects to humans or the environment and for which there is existing or potential future legislation that may restrict use. Our process development teams develop strategies to eliminate or substitute the use of these materials. Genetically modified organisms We use genetically modified organisms (GMOs) in the research and development of new therapeutic agents and in the manufacture of certain medical products such as vaccines. All our work with GMOs is controlled to the strictest national and international regulations, and we apply best practice across all our facilities. REACH In 2008, we continued to work to reduce risks to continuity of supply of chemicals presented by the introduction of the EU¶s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation. Global harmonisation We continue to prepare for impending changes to classification and labelling of hazards as part of the UN¶s Globally Harmonised System for Classification and Labelling of Chemicals regulation.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Sustainability Product stewardship Pharmaceuticals in the environment
Corporate Responsibility Report 2008 Pharmaceuticals in the environment Some portion of active pharmaceutical ingredients (APIs), the substances that make medicines work, may eventually be excreted by humans and enter the environment. Wastewater treatment removes most pharmaceutical residues but small concentrations do end up in rivers or in the sea and very low concentrations of some pharmaceuticals are occasionally found in drinking water. In countries where wastewater is not treated, higher concentrations may enter the environment. We conduct tests and risk assessments to evaluate the potential effects of our pharmaceutical products on the environment. To date these indicate that our products do not appear to pose a risk for humans or the environment based on current risk assessment methodologies and information. We conduct retrospective analysis of environmental data to refine our testing methodology and assessment models. We recently revised our material testing strategies to include chronic testing (to determine the impact of our products on the environment over the long term) and mode of action analysis (to identify the most sensitive species), to meet new regulatory guidelines and to improve our understanding of possible environmental effects. We are committed to transparency about the data we collect and make environmental data publicly available. Assessments and environmental data for individual APIs are provided online in Safety Data Sheets. Data are also available on the Swedish Doctors Prescribing Guide (see below). We make information about pharmaceuticals in the environment available to the public by publishing the results of our risk assessments in scientific journals. Read our public position statement about pharmaceuticals in the environment. In the EU and US, environmental risk assessments are part of the approval process for producing and marketing new medicines. They allow regulatory agencies to assess the potential for environmental impacts of drugs pending approval. We work with regulatory agencies to ensure that the potential environmental impacts of our pharmaceuticals are understood and minimised. We continue to monitor the latest scientific studies and findings to improve our risk assessment methodology. In addition, we conduct and contribute to environmental research in this area. We recently completed a study and submitted a scientific paper assessing the potential impacts on human health from environmental exposures for around 35 APIs included in GSK pharmaceuticals. We are also beginning to study the possible impacts of mixtures of various compounds in household wastewater at extremely low concentrations, which include our pharmaceuticals as well as other pharmaceuticals and household products. Although the main source of pharmaceuticals in the environment is patients excreting medicines they have taken, GSK has established limits for active pharmaceutical ingredients in wastewater from our manufacturing sites. Based on our studies, we establish safe levels for API, based on a demonstration of no risk. We assess process waste concentrations against these established levels and treat the wastewater if required to ensure that the safe levels are achieved so that there is no subsequent environmental risk. Industry collaboration We work with other pharmaceutical companies, universities and research groups on activities around pharmaceuticals in the environment. We also collaborate on joint projects with industry groups and sponsor academic studies. For example, we submit environmental data on our products as part of the Swedish classification system for pharmaceuticals, a collaboration between the Swedish Pharmaceutical Association and the Swedish government. This is a voluntary transparency initiative making information about
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environmental risks available to the public, doctors and scientists. We participate in technical working groups on pharmaceuticals in the environment sponsored by the industry group Pharmaceutical Research and Manufacturers of America (PhRMA). Through PhRMA and the Association of the British Pharmaceutical Industry, we continually engage with regulatory scientists from the US Environmental Protection Agency, the US Food and Drug Administration and the UK Environment Agency.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Sustainability Product stewardship Materials of concern, GMOs and nanomaterials
Corporate Responsibility Report 2008 Materials of concern, GMOs and nanomaterials Materials of concern Materials of concern are chemicals where scientific evidence shows probable serious long-term effects to humans or the environment and for which there is existing or potential future legislation that may restrict use. These compounds include so called PBTs (substances that persist in the environment, bioaccumulate in animals and plants or are toxic to life), carcinogens, mutagens, reproductive toxins, substances known to cause asthma, endocrine disrupting chemicals and ozone depleting substances. Our EHS team works with our process development teams to help them develop strategies to eliminate or substitute the use of thesematerials. Read our position paper on hazardous chemicals management. Performance In 2008, we used 56 metric tonnes of materials of concern, 95 per cent of which was accounted for by five solvents. Most of the solvent waste from this production was destroyed by incineration, although some of it was recycled as part of the work in our pilot plants. We also examined the use of materials of concern across all phases of development. This determined which substances are being used and identified how they can be replaced during development.
Genetically modified organisms We use genetically modified organisms (GMOs) in the research and development of new therapeutic agents and in the manufacture of certain medical products such as vaccines. We use GMOs to identify the genetic targets and causes of disease and to develop new antibiotics and drugs for conditions such as heart disease, diabetes and depression. We use a number of different GMOs, predominantly harmless organisms such as disabled strains of the bacterium E.coli and eukaryotic cells in culture. We also manufacture a number of products that are derived from genetically modified materials, such as hepatitis B vaccine. We do not produce or plan to produce any products that are, or contain, viable organisms. All our work with GMOs is controlled to the strictest national and international regulations, and we apply best practice across all our facilities. Any work with GMOs is subject to full risk assessment, ensuring safe use, storage and disposal. All processes are performed in closed vessels minimising the risk of release. The large-scale fermentation or propagation of GMOs is always undertaken in fully contained systems. Research is performed in containment laboratories appropriate to the risk of the materials handled. Work is controlled by written procedures, and we carry out regular maintenance checks. We treat all waste from our GMO operations to ensure we do not release viable GMOs from our contained processes into the environment. All GMOs are deactivated prior to disposal by chemical or heat treatment. We do not routinely undertake research and development involving the cultivation of genetically modified plant species.
Nanomaterials Nanotechnology is an area of science that involves controlling nanomaterial which are materials that are on an atomic or molecular scale. Nanotechnology may in future be used to develop new medicines.
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We have participated in a Responsible Nano Code consultation for the development of a code of conduct for businesses that use nanotechnology. Responsible Nano Code is a collaboration between the Royal Society, Insight Investment and the Nanotechnology Industries Association. We estimate that we will not begin using nanotechnology until around 2011.
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Home Responsibility Environmental sustainability Sustainability Product stewardship REACH
Corporate Responsibility Report 2008
REACH In 2008, we continued to work to reduce risks to continuity of supply of chemicals presented by the introduction of the EU¶s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation. This involved: Using site inventories from EU and international sites to identify any chemicals sourced from EU suppliers or imported or manufactured by GSK Contacting companies that supply GSK with chemicals covered by REACH to assess their plans for management of potential risks to continuity of supply to GSK. This involved the evaluation of over 1,000 suppliers Pre-registering any phase-in material manufactured or imported by GSK in volumes of more than one tonne per year Registering any new substances we manufacture or import in volumes of less than one tonne per year Read about our position on REACH on gsk.com
Our plans From 2009 we will start to gather information about use of materials and EHS hazard data required to meet the first REACH registration milestone of November 2010 for phase-in substances. We will also continue to work with our suppliers to ensure that they meet their REACH obligations and will collaborate with other companies via Substance Information Exchange Forums (SIEF) to share any hazard data we have on substances of mutual interest that require REACH registration.
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Home Responsibility Environmental sustainability Sustainability Product stewardship Global harmonisation
Corporate Responsibility Report 2008 Global harmonisation We continue to prepare for impending changes to classification and labelling of hazards as part of the UN¶s Globally Harmonised System for Classification and Labelling of Chemicals (GHS) regulation. This includes: Changing the way we produce safety data sheets to ensure compliance Initiating the process of reclassifying all substances we manufacture or import following GHS rules Developing training for employees on new hazard warning symbols and labels introduced as part of GHS Read our position paper on hazardous chemicals management.
Our plans During 2009 we will work with GSK operations to evaluate hazard labelling solutions that will facilitate production of GHS compliant labels based upon the revised classifications being developed.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Sustainability Packaging
Corporate Responsibility Report 2008 Packaging We are working to reduce the environmental impact of packaging for our pharmaceutical and consumer healthcare products. Our µgreen packaging guide¶ provides guidance for evaluating and selecting packaging. It allows designers and managers to benchmark new and existing packaging designs using five metrics: Manufacturing impacts Mass of the material Biodegradability PVC content Resource depletion of petrochemical feedstocks One example of reducing the impact of our packaging is the use of 100 per cent recycled plastic for our Ribena bottles, achieved despite the challenge of sourcing sufficient quantities of recycled plastic. Ribena packaging
Our Nutritionals business has embedded sustainability into every aspect of its business as evidenced by the work done on Ribena. We work on biodiversity with the farmers that grow our berries, we work towards a goal of µzero waste to landfill¶ from manufacturing Ribena and we use 100 per cent recycled materials for our bottles. From these actions we have realised the benefits of sustainability, benefits to the environment, our customers and our business. The work done on bottling is just one example of our approach. We produce hundreds of millions of bottles of Ribena and Lucozade a year. The bottles are made from a type of plastic known as PET. We estimate that packaging such as this can form as much as 60 per cent of our Nutritional Healthcare products¶ environmental impact. In 2008 we launched the UK and Europe¶s first 100 per cent recycled and recyclable drinks bottle, for our Ribena squash and ready-to-drink products. Previously we had packaged Ribena in a bottle made from 40 per cent recycled material. In 2008 we filled over 125 million of the new bottles with Ribena. By using 100 per cent recycled material, we avoided the emission of 8,000 tonnes of CO 2 and prevented a total of 3,500 tonnes of waste from being sent to landfill. The bottles can also be recycled by consumers after use. We are trying to understand what would make people recycle when they are away from home by trialling µreverse vending machines¶ at major shopping centres. People can put used drinks bottles into the machines, which crush and compact them ready for collection and recycling. The new bottles contribute towards our targets for GSK Nutritional Healthcare products to use 25 per cent less packaging, and use packaging made from an average of 50 per cent recycled materials by 2010. This project won The Vanguard Award in the 2008 CEO¶s EHS Excellence Awards
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Environmental sustainability Open and transparent relations
Corporate Responsibility Report 2008 Open and transparent relations We aim to be transparent and open about the environmental impacts of our products and processes. This helps us build trust with our stakeholders and provides assurance that we are managing environment, health, safety and sustainability (EHSS) risks. We report our progress against our EHSS objectives in our annual corporate responsibility report and respond to specific requests for information throughout the year. We also engage more formally with stakeholders to gather feedback on our approach and performance and to address their concerns.
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Home Responsibility Environmental sustainability Open and transparent relations Stakeholder engagement
Corporate Responsibility Report 2008 Stakeholder engagement We engage with stakeholders at corporate and local level to inform our plans and approach to managing EHSS and to help identify emerging issues. This includes ad hoc meetings and formalised feedback from our stakeholder panel in the UK (created in 2005) and an EHS stakeholder workshop held in the US for the first time in 2007. In 2008 we expanded the role of the UK panel to provide input to the Sustainability Council. This Council is composed of senior GSK managers and was formed in 2008 to consider the sustainability issues that are important to GSK and recommend actions. This is a component of GSK¶s larger effort to address public concerns about how we conduct our business. We engage with regulators to help them develop controls that protect the environment while safeguarding the development and launch of new medicines. Read more about how we engage with stakeholders and the feedback we receive. See how we fare in benchmarks.
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Home Responsibility Environmental sustainability Open and transparent relations EHSS reporting
Corporate Responsibility Report 2008 EHSS reporting Our primary objective in collecting EHSS performance data is to help our operations manage EHSS issues. This is done through EHS Manager, a web-based information management system. We focus our external reporting on the environmental issues that are most relevant to GSK and of most interest to our stakeholders. Read about our overall approach to corporate responsibility reporting Read about our approach to health and safety and our health and safety performance
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Home Responsibility Environmental sustainability Open and transparent relations Assurance
Corporate Responsibility Report 2008 Assurance SGS Assurance statement
SGS UNITED KINGDOM LTD¶S REPORT ON ENVIRONMENT, HEALTH AND SAFETY DATA IN THE GLAXOSMITHKLINE CORPORATE RESPONSIBILITY REPORT FOR 2008 NATURE AND SCOPE OF THE ASSURANCE SGS United Kingdom Ltd was commissioned by GlaxoSmithKline (GSK) to conduct an independent assurance of the Environmental, Health and Safety data in their Corporate Responsibility (CR) Report for 2008. The scope of the assurance, based on the SGS Sustainability Report Assurance methodology, included 2008 data contained in the following sections of this report: Waste water
Injury & illness rates
Waste
Injury & illness causes
Emissions to air
Fatalities and serious injuries
Climate change
Ergonomics
Energy
Driver safety
Transport impact
Health and safety data table
Water use Environment data table The information in the GSK CR Report and its presentation are the responsibility of the directors and management of GSK. SGS United Kingdom Ltd has not been involved in the preparation of any of the material included in the CR Report. Our responsibility is to express an opinion on the data, graphs and statements within the scope of verification. Financial data drawn directly from independently audited financial accounts has not been checked back to source as part of this assurance process. The SGS Group has developed a set of protocols for the Assurance of Sustainability Reports based on best practice guidance provided in the Global Reporting Initiative Sustainability Reporting Guidelines (2006) and the AA1000 Assurance Standard (2003). These protocols follow differing levels of Assurance depending the reporting history and capabilities of the Reporting Organisation. This report has been assured for content veracity. The assurance comprised a combination of interviews with relevant employees; documentation and record review at nineteen GSK locations during and at the end of the reporting year as follows: Interim site visits during October 2008 in France (Evreux, Notre Dame de Bondeville, Saint-Amand-LesEaux), India (Nabha), Italy (Verona - GMS and R&D), Nigeria (Agbara), UK (Slough, Stevenage R&D, Ware GMS, Worthing) and USA (Clifton, Memphis, Research Triangle Park R&D). End of year site visits during January and February 2009 in India (Nashik, Thane), Ireland (Cork) and UK
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(Irvine, Ulverston and Corporate CSR function in London). The sites selected included those submitting high proportions of key data and included all parts of the GSK business. STATEMENT OF INDEPENDENCE AND COMPETENCE The SGS Group of companies is the world leader in inspection, testing and verification, operating in more than 140 countries and providing services including management systems and service certification; quality, environmental, social and ethical auditing and training; environmental, social and sustainability report assurance. SGS United Kingdom Ltd affirm our independence from GSK, being free from bias and conflicts of interest with the organisation, its subsidiaries and stakeholders. The assurance team was assembled based on their knowledge, experience and qualifications for this assignment, and comprised auditors and assurors registered with IRCA, IEMA and EMAS Verifiers. ASSURANCE OPINION On the basis of the methodology described and the verification work performed, we are satisfied that the Environmental, Health and Safety data contained within the GSK Corporate Responsibility Report 2008 is reliable and provides a fair and balanced representation of GSK¶s Environmental, Health and Safety activities in 2008. We believe that GSK has chosen an appropriate level of assurance for this stage in their reporting. Key areas for improvement to data collection, submission and manipulation were identified during the assurance process and, as far as possible, were addressed to incorporate improvements into this report. These improvement opportunities are outlined below to enable further review to establish the need for system or process changes in future reporting cycles: Some data points which are collated centrally at year end were not fully reviewed to identify anomalies leading to an inconsistent approach in estimating missing data. Several data points have been calculated using new emissions factors and previous years¶ data is restated using the same calculation to allow year-on-year comparison. It is important to ensure that any restated information is fully explained and references to factors used remain current. Some significant contributors to selected data points failed to submit required information. Calculation methodology for ozone depleting substances from patient use of inhalers was updated for one production site but not the remaining sites. It was noted that reported data for previous years may change slightly due to obtaining additional data submissions or updating estimates after publication date. Some anomalies were identified in data submitted when reviewing site level data and comparing 2008 with previous years¶ submissions. Some of these included examples where data had been entered twice following a change to the database. Improvement opportunities identified from site visits were mainly site specific with the most common observations focussing around the following areas: Manual transfer of data and the opportunity for mistakes and variations in roundings in transfer; Utilising the benefits of improvement in regular review and internal checks of data accuracy and formalising secondary review of manual transfers, rather than end of year checks; Extension of monthly reporting rather than quarterly or annual. Improvements identified in previous reporting period have started to be implemented as follows: Specific reports in EHS manager have begun to be implemented, such as the energy module, to reduce the need for additional data transfer from spreadsheets at site level. There may be additional opportunities to extend this to other areas such as waste data provided by key subcontractor. During site visits conducted it was noted that the staff were well prepared and able to provide required
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evidence to the auditors in the majority of cases, particularly on sites which had undergone previous visits. In addition required changes were generally made promptly where possible. Data from ancillary services or site activities has started to be included, with explanation provided in the comments section of EHS Manager, however site visits identified that there remain some missing items. Review of data submissions indicated an increase in monthly reporting rather then annual or quarterly allowing for more regular review and update of data entries and also indicating discrepancies more clearly. The majority of site visits were conducted in the last quarter of 2008 which enabled issues of concern to be identified and dealt with earlier in the assurance process. Key areas for improvement in data verification process were identified as follows: Sites selected for visits should be identified at the earliest opportunity in order to enable visits to be completed alongside ISO14001/OHSAS18001 certification audits where possible. Recommended that site visits are completed during the last quarter of 2009 to enable any follow-up required to be completed before end of year verification is performed. Recommend selection of key indicators for full review of calculation methodologies across all major contributors, for example VOC and COD emissions and hazardous waste disposal for Primary sites. Recommend site visits include detailed review of source evidence for ozone depleting substances from equipment. Recommend sites selected for visits include: a sample of sites manufacturing inhalers in order to verify data back to source; a sample of sites with significant contributions that failed to submit data; and a sample of sites where significant changes have occurred which were reflected in data submitted. Signed: For and on behalf of SGS United Kingdom Ltd
Pauline Earl Managing Director 25 February 2008 WWW.SGS.COM
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Home Responsibility Environmental sustainability Open and transparent relations GSK response to assurance
Corporate Responsibility Report 2008 GSK response to assurance GSK response to SGS, March 2009 This is the third year that SGS has reviewed the data in the µEnvironment¶ and the injury and illness data in the µPeople¶ section of the Corporate Responsibility report. Verification is complex due to the large amount of data covered and every year the SGS auditors suggest improvements based on their findings. Their unbiased view of our data and processes has been very valuable and we have adopted their suggestions. As a result the quality of our systems and data has continued to improve over the years. SGS selects sites for review based on the magnitude of the contribution of the sites to the overall GSK performance, the types of operations and the degree of difficulty the sites seem to have with reporting. We believe their site evaluations are valuable learning experiences for site personnel. The data included in the corporate responsibility report can be used by the individual sites to monitor and improve their environmental programmes and their health and safety programmes. Therefore, the SGS data verification not only assures the veracity of the data for the corporate responsibility report, it also improves the accuracy and therefore usefulness of data for the sites. We still find challenges in collecting complete and accurate data in a timely fashion. We are committed to continuing to improve this record so that we reach our goal to be able to provide accurate data to the public on the website in real time. Responses to specific key areas for improvement for this year: Selecting sites so they can be reviewed as part of ISO certification Sites have already been selected for the 2009 review so they can be verified in combination with any ISO certifications that take place this year Site visits to be completed during last quarter of 2009 Sites will be notified of their selection for verification visits in the first quarter of 2009 so visits can take place in the last quarter or in conjunction with ISO certification visits earlier in the year Selection of key indicators for full review of calculation methodologies We will work with our sites that manufacture active pharmaceutical ingredients and are the principal contributors to our VOC and COD emissions and hazardous waste to review their calculation methods over the course of 2009 Site visits to include detailed review of source evidence for ozone depleting substances from equipment We will prepare reports of the refrigeration equipment register and SGS will include this in their 2009 site reviews Sites selected for visits to include manufacturers of inhalers, sites that failed to submit data and sites that had significant changes after data were submitted The sites selected for review in 2009 fully represent these groups including some large sales groups that submitted incomplete or late data on injuries and illnesses, and sites from all businesses and regions that made significant data errors We look forward to the improvements that attention to these areas will bring in 2009. James Hagan
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Vice President, Corporate Environment, Health, Safety and Sustainability
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Home Responsibility Environmental sustainability Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders. Your inhaler products have a large environmental impact. What are you doing about this? We have been phasing out CFCs from our inhaler products for the last 15 years, replacing these gases with HFAs which have a lower climate change impact (16 per cent that of CFCs). Less than two per cent of our inhalers now contain CFCs and we have committed to a complete phase-out by 2010. As part of our new climate strategy, we are exploring ways to reduce the amount of HFAs released from our inhaler products and we are looking into alternative propellants. We also offer dry powder inhalers for asthma sufferers which contain no greenhouse gases. These are not suitable for all patients, particularly children and the elderly, as they do not contain propellants and rely on a person¶s lung power for the active ingredients to be administered. How can the pharmaceutical manufacturing process be made more efficient? Making medicines is highly regulated and is complicated due to the number of process steps required. We know that there is more we need to do to improve efficiency and we have set a target to double the average materials efficiency of manufacturing processes for new products introduced between 2006 and 2010. Are pharmaceutical residues present in drinking water and are they a risk to humans? Our studies have shown that GSK pharmaceutical products are either not present in watercourses, or are present at low concentrations. Our risk assessments demonstrate that these concentrations do not pose a risk to human health or the environment. But we are not complacent and we continually monitor the latest scientific studies and findings to improve our risk assessment methodology. Back to top
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Home Responsibility Environmental sustainability Environmental metrics
Corporate Responsibility Report 2008 Environmental metrics Metric
2001
2005
2006
2007
2008
Energy for operations (million gigajoules)
20.7
19.4
19.3
19.3
19.2
Natural gas
9.87
8.78
9.09
9.04
9.15
Fuels
1.40
1.50
1.08
1.06
0.83
Coal
1.04
0.63
0.47
0.51
0.59
Steam imported
0.28
0.21
0.23
0.22
0.19
Electricity imported
8.10
8.30
8.39
8.45
8.43
Energy for transport 1 (million gigajoules)
5.2
5.2
5.1
Sales force
2.1
1.9
1.7
Air travel
1.6
1.6
1.7
Product logistics
1.4
1.7
1.7
Energy use
Electricity from sustainable sources
0.39
0.14
0.23
0.32
0.26
3,704.5
2,637.2
7,254.3
7,633.5
7,030.8
1,798.5
1,717.5
1,704.0
1,701.7
1,722.3
Natural gas
504.0
448.7
464.5
462.6
467.3
Fuels
86.9
98.7
74.5
72.9
59.7
Coal
93.5
56.8
42.6
45.4
53.2
Steam imported
39.1
16.3
15.8
16.3
12.7
Climate change impact (CO 2 equivalents) 2 Total climate change impact (million kilograms CO 2 equivalent)
CO 2 equivalents from operations energy (million kilograms)
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Electricity imported
1,074.9
1,096.9
1,106.7
1,104.5
1,129.6
CO 2 equivalents from transport (million
123.0
233.0
363.2
363.0
360.8
Sales force
33.0
102.0
145.4
129.0
114.8
Air travel
71.0
112.0
115.8
112.2
123.5
Product logistics
19.0
19.0
102.0
121.7
122.5
CO 2 equivalents from other production
1,783.1
686.7
502.3
369.0
282.2
Inhaler production losses
1,578.8
543.4
398.1
289.1
198.6
Equipment containing greater than 1kg refrigerant 3
116.9
46.8
12.8
13.6
12.8
87.4
96.5
91.4
66.2
70.8
4,685
5,200
4,666
CFC-11 inhalers
242
181
116
CFC-12 inhalers
1,083
1,071
688
HFA-134a inhalers
3,360
3,948
3,861
kilograms)
activities (million kilograms)
CO 2, methane and nitrous oxide from production, waste treatment and other sources CO 2 equivalents from use of inhalers by patients 4 (million kilograms)
Water use and discharge Water (million cubic metres)
26.8
21.8
22.3
20.9
19.7
Municipal
15.20
12.82
12.94
12.23
11.62
Wells or boreholes
11.56
8.59
8.95
9.27
7.78
Other water 5
0.04
0.35
0.37
0.35
0.34
Wastewater volume 6 (million cubic metres)
20.7
16.6
11.7
10.9
10.8
Wastewater to recycling
1.29
1.04
0.73
0.58
0.52
Wastewater to municipal sewer
9.90
8.12
5.67
5.35
5.44
Wastewater to water bodies
9.48
7.46
5.35
5.01
4.83
COD after on-site treatment 6,7 (million kilograms)
27.3
18.7
15.9
14.3
14.9
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COD in recycled water
0.06
0.06
0.01
<.01
0.01
COD to municipal sewer
6.04
4.87
4.08
4.05
3.80
COD to water bodies
21.17
13.81
11.83
10.20
11.08
Hazardous waste generated 8 (million kilograms)
350.7
261.0
241.1
221.8
237.5
Hazardous waste recycled
288.41
193.62
170.73
149.86
183.11
Hazardous waste disposed
62.31
67.36
70.33
71.98
54.36
Hazardous waste incinerated with energy recovery 9
28.69
29.90
30.38
32.72
20.20
Hazardous waste incinerated with no energy recovery
30.25
36.06
39.45
38.68
32.53
Hazardous waste to landfill
3.37
1.40
0.50
0.58
1.64
Non-hazardous waste generated (million kilograms)
132.8
124.0
114.7
120.3
109.4
Non-hazardous waste recycled
79.34
83.82
78.48
83.48
76.55
Non-hazardous waste disposed
53.49
40.20
36.22
36.85
32.87
Non-hazardous waste incinerated with energy recovery 9
5.92
9.94
8.69
8.83
8.35
Non-hazardous waste incinerated with no energy recovery
12.05
6.53
4.93
4.87
4.85
Non-hazardous waste to landfill
35.52
23.73
22.60
23.15
19.67
Non-routine waste generated 10 (million kilograms)
25.3
77.9
28.1
37.7
18.9
Non-routine waste recycled
2.29
39.97
11.10
23.04
11.97
Non-routine waste disposed
22.98
37.96
17.00
14.63
6.90
Non-routine waste incinerated with energy recovery
1.55
7.46
2.55
4.21
0.49
Non-routine waste incinerated with no energy recovery
0.24
0.39
0.79
0.82
1.13
Non-routine waste to landfill
21.19
30.12
13.65
9.60
5.29
Waste generated and disposed
Volatile organic compound emissions
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Volatile organic compound emissions 11 (million kilograms)
6.8
5.2
4.4
4.5
3.9
Acetone
1.24
1.15
1.06
0.96
1.03
Dichloromethane
1.74
0.88
0.85
0.75
0.63
Methanol
0.75
0.71
0.46
0.64
0.54
Ethanol
0.36
0.54
0.46
0.57
0.37
Isopropanol
0.39
0.20
0.28
0.18
0.18
Toluene
0.42
0.06
0.09
0.26
0.06
ODS releases from production (thousand kilograms)
183.5
51.0
32.9
14.9
5.4
CFC-11 releases from production
88.55
14.11
19.35
3.22
1.59
CFC-12 releases from production
94.90
36.86
13.51
11.63
3.82
Ozone depletion potential of refrigerants released from eqauipment (thousand kilograms CFC-11 equivalent)
4.3
3.0
0.7
0.6
0.5
CFC-11 releases from equipment
0.56
1.62
0.42
0.38
0.26
CFC-12 releases from equipment
0.33
0.21
0.02
0.02
0.03
Other ODS from equipment
3.42
1.15
0.22
0.16
0.19
ODS released from patient use of inhalers 13
272.5
182.2
136.5
87.7
CFC-11 from patient use
76.15
50.91
38.14
24.49
CFC-12 from patient use
196.38
131.29
98.35
63.16
23.9
20.5
16.2
Top six solvents released to air (million kilograms)
Ozone depleting substances 12
ODP of refrigerants contined in equipment 14 (thousand kilograms CFC-11 equivalent) Estimated costs and investments Operations and maintenance cost (million )
41.6
39.3
33.9
33.1
31.3
Capital investment (million )
24.4
12.1
9.7
16.8
12.9
Footnotes
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
1. Energy and climate change impact for travel and transport by air, land and sea are calculated using the Greenhouse Gas Protocol starting from distance travelled, not directly from fuel use. In years before 2006 we did not collect all categories of freight transport or employee business travel. Some of the transport data are estimated and we may not capture all routes and employee air travel. 2. Climate change impact is calculated as CO 2 equivalent using the Greenhouse Gas Protocol developed by the World Resources Institute and the World Business Council for Sustainable Development. Each year we review the CO 2 factors and update the data for all years as appropriate. The greatest changes are generally in the updated factors for electricity. 3. In 2008 we reviewed the refrigeration equipment inventories for 2006, 2007 and 2008. Where inventories were incomplete they were estimated based on inventories in other years. We also updated the factors for ozone depletion potential and climate change emissions using WMO (World Meteorological Organisation), Scientific Assessment of Ozone Depletion: 2006, Global Ozone Research and Monitoring Project²Report No. 50, 572 pp., Geneva, Switzerland, 2007. (chapter 8). We calculate the probable releases using a factor from the British Refrigeration Association. 4. We did not have enough information to calculate climate change impact from inhaler use before 2006. 5. Water from other sources includes recycled sources 6. We focus collection of wastewater and chemical oxygen demand data primarily on the major contributors; primary manufacturing operations, pilot plants, coating activities and sterile operations. Some sanitary wastewater streams are included if they cannot be separated from production wastewater streams or if they are significant. 7. Chemical oxygen demand (COD), a measure of water pollution, is measured when wastewater leaves our sites following any onsite treatment. 8. We consider a waste to be hazardous if it has any of the properties defined by the 1989 Basel Convention or if it is radioactive, bioengineered or biohazardous. Basel Convention properties include flammability, explosivity, water or air reactivity, corrosivity, oxidising potential, acute or chronic toxicity, ecotoxicity or infection. Biological waste rendered non-hazardous after treatment is considered non-hazardous waste. We focus collection of hazardous waste on the major contributors; primary manufacturing operations, pilot plants, coating activities and sterile operations. 9. Incineration with energy recovery means burning the material and using the resulting energy. 10. Non-routine waste includes construction and demolition rubble and is not included in hazardous or nonhazardous waste calculations. 11. We focus collection of volatile organic compound emissions on the major contributors; primary manufacturing operations, pilot plants, coating activities and sterile operations. 12. We used WMO (World Meteorological Organisation), Scientific Assessment of Ozone Depletion: 2006, Global Ozone Research and Monitoring Project²Report No. 50, 572 pp., Geneva, Switzerland, 2007. (chapter 8) for ozone depletion potential and climate change emissions factors. 13. Before 2006 we did not have information about inhalers produced in Asia so it was not included in ODP or GWP calculations until 2006. 14. Before 2006 we did not have information about the amounts of refrigerants contained in equipment Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people
Corporate Responsibility Report 2008 Our people Good employment practices are essential to achieve our business strategy. Our goal is to µbe the best place for the best people to do their best work¶. We employ over 90,000 people in 114 countries across the world. The essential characteristics of a good workplace are integrity, diversity and inclusion, development and creativity. Integrity is critical in everything we do. The GSK spirit defines the culture and behaviours we expect from our employees. Any failures of integrity risk damaging our long-term success. Diversity and inclusion in our workforce demonstrate our commitment to equal opportunities, and enhance our business. Diversity and inclusion help us attract the best people in each of the countries in which we operate, give us a wide range of perspectives to draw on and enhance our understanding of local market needs. Development of our employees means they are more likely to stay with GSK and contribute their best to our success. We encourage our employees to achieve their full potential through training programmes and onthe-job development. We offer a supportive and safe work environment and competitive reward packages. Creativity is fostered in the best work environments. Our aim is that GSK workplaces empower our people to be creative and innovative in their work, for the benefit of the company, shareholders, customers and patients. Employment awards
A selection of the employment awards won by GSK in 2008: UK Ranked fourth in the 2008 Britain¶s Top Employers survey by CRF International and published by Guardian books Best in class in Engineering and Science and shortlisted for best Graduate Employer in Target awards, voted for by graduates and post-graduates Received The Times Employers of Choice for Research and Development Award, based on results of undergraduate interviews Ranked 14th in The Times Top 100 Graduate Employers Survey, a list of organisations that new graduates most want to work for First in the Employee Benefits Award for the most effective use of employee financial education in the workplace, awarded by Employee Benefits magazine Highly commended in PricewaterhouseCoopers Building Public Trust Awards in µPeople reporting¶ category, based on disclosure and strength in human capital management and employee practices US Awarded a perfect score (100 per cent) for Corporate Equality by the Human Rights Campaign Foundation and listed as one of the best places to work for gay, lesbian, bisexual and transgender equality Named one of the 100 best companies by Working Mother magazine, for the 16th consecutive year Awarded platinum honours for workplace and lifestyle programmes, by the National Business Group on
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Health. Identified as a leader in providing a healthy workplace and promoting a healthy lifestyle for employees and their families
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Our culture and behaviours
Corporate Responsibility Report 2008 Our culture and behaviours Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. We place great emphasis not only on what we achieve, but also on how we deliver our achievements. Integrity is critical in everything that we do. The GSK spirit defines the culture and behaviours we expect from all our employees: Culture Passionate people Patient-focused Performance with integrity Behaviours Innovative thinking Engaging and developing others Leading people Achieving excellence Our mission and spirit help our employees deal with new challenges and maintain a clear focus. We raise awareness of the GSK spirit and help employees to understand and adopt its principles through workshops, team meetings, presentations and awards. We are working to individually empower each of our employees. Empowerment means trusting employees and recognising and rewarding them for achieving their objectives. It helps to encourage innovation and entrepreneurship, and is good for employee morale. Empowered employees take responsibility for their tasks, are able to prioritise better and make decisions more quickly and effectively. Achieving a culture of individual empowerment across GSK will motivate our staff, make us more effective and improve our ability to deal with challenges.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Restructuring
Corporate Responsibility Report 2008 Restructuring In October 2007, we announced a three-year Operational Excellence programme to improve the effectiveness and productivity of our operations. We launched the programme as a response to a more challenging business environment and forecast that it would deliver annual pre-tax savings of up to 700 million by 2010. In February 2009 we announced an expansion to this restructuring programme, to realise increased pre-tax annual savings of 1.7 billion by 2011. In 2009, savings from restructuring will mitigate the decline we expect to our gross margin due to product mix changes with a higher percentage of sales generated from vaccines, Consumer Healthcare and Emerging Markets, and support further investment behind our strategic priorities. The programme includes initiatives to streamline manufacturing, adapt our selling model and improve efficiency in R&D. We are very conscious of the effect this programme will inevitably have on our employees and if options exist where we can achieve our financial goals and preserve jobs we will do everything we can to do so. We consult with employees and their representatives before we implement measures that affect them, such as outsourcing, site closures and staff reductions. We always speak to affected employees first (except where local regulations do not allow it) and then our works councils, trade unions and other employee representatives as appropriate. We aim to treat our employees with dignity and respect and offer a wide range of support for all affected employees. This includes a competitive severance package and outplacement support such as assistance in finding alternative employment, career counselling and retraining. We also work hard to maintain the morale of all other employees at GSK.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Consultation
Corporate Responsibility Report 2008 Consultation In Europe our staff or works councils and European Employee Consultation Forum meet regularly, providing an opportunity for employees and company management to discuss key issues and developments in the business. We also recognise trade unions for consultation and collective bargaining in many countries worldwide. Our European Employee Consultation Forum, which includes employee representatives from 28 EU countries, works alongside national consultation processes and is governed by UK law. There is an Operating Sub-Committee of six employee representatives who meet four times a year with six management representatives to receive updates and review proposals affecting the structure of the business. Extraordinary Operating Sub-Committee meetings can be called should the need arise. The whole of the Forum meets once a year at an Annual Meeting to receive a business update from senior GSK executives. In 2008, Eddie Gray, President of GSK Pharmaceuticals Europe, and other business leaders spoke about the opportunities presented by new products in the R&D pipeline, the challenge of growth within Europe and GSK¶s vision for developing the Consumer Healthcare business. We also discuss issues through national consultation forums. For example, the UK Information and Consultation (I&C) Forum which consists of 15 GSK elected employee representatives and seven managers and meets three times a year. In 2008, the I&C Forum reviewed and amended a number of GSK¶s UK policies including those on driving while on company business, further education and special leave. The Forum also continued to review UK-wide redeployment and selection guidelines for redundancy and proposals to handle pension legislation changes taking effect in April 2010. In 2008, the Forum received presentations on strategy from senior managers within Global Manufacturing and Supply and R&D.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Communication
Corporate Responsibility Report 2008 Communication Approach
Performance & plans
Good two-way communication with our employees is vital. We aim to keep everyone well informed and involved in company activities, and provide opportunities to get their feedback. Our internal communications channels include: Face-to-face communications, for example through µtown hall¶ style meetings, lunches with the Corporate Executive Team, conferences and team meetings The GSK Experience programme for new starters. This is a mandatory, two-day induction programme that teaches new employees in the UK and US about GSK. Feedback indicates the programme helps them to feel valued and involved. Other countries arrange their own induction programmes locally Spirit, our internal magazine. We print and distribute 33,500 copies throughout the company, four times a year. Spirit is also published on our intranet, myGSK, reaching a broader audience than print alone and allowing our employees to easily give us feedback on articles they have read Our global intranet site, myGSK, provides updates on company and industry news, and a large range of information and resources for employees. myGSK has several features for employees including: myCEO, a dedicated part of the intranet where staff can pose questions to our Chief Executive Officer (CEO) and the other members of the Corporate Executive Team. Employees ask approximately 70 questions each month and our CEO¶s answers are posted regularly on the site The Ambassador intranet community which provides reference materials, information and tools for employees to use as a reference, including presentations, facts and figures An interactive intranet feature, Your Story, which allows our employees to share stories about what inspires them and how this impacts their work with the company An email cascade system where messages are sent to business leaders to share with employees, for example details of our latest financial results Surveys that enable us to monitor employee engagement and help us to track the impact of our internal communications
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Communication
Corporate Responsibility Report 2008 Communication Approach
Performance & plans
Internal communications Some of the ways that we communicated with our employees in 2008: CEO communications As CEO designate, Andrew Witty held nine employee forums with 250 employees from across the world to help inform his strategic priorities for GSK As CEO, Andrew Witty hosted three global employee broadcasts, recorded live in front of an employee audience. These broadcasts are available for employees to view throughout the year as video on demand via our online video library GSKtv A CEO Advisory Board has also been established which will act as an informal sounding board for ideas. The Board will be filled by employees from across the company Communicating with our senior leaders We held meetings with senior leaders in April and September 2008 to support alignment of the different parts of our business with our new strategic priorities. These were attended by 1000 and 200 leaders respectively. Online communications In 2008 we launched several new features on the company intranet, myGSK, including: A new myCEO discussion forum, called µLet¶s talk¶, designed to support the transition to a new CEO. This received 176 comments from employees between May and December 2008. Employees also sent 456 questions to the myCEO Q&A facility The online version of our employee magazine, Spirit, in September 2008. We also redesigned the magazine and now print it on 100 per cent recycled, chlorine-free paper GSKtv, an online multi-media library which allows employees to view and download a range of videos from across the organisation A new internal website that provides employees with information about what to do in the event of a flu pandemic. Read more about GSK¶s flu pandemic preparedness Business communications Our business units communicate directly with employees through the intranet, µtown hall¶ meetings and other face-to-face meetings, broadcasts and video messages. Many members of the Corporate Executive Team also run live web chats and host Q&A sessions on their intranet communities, ensuring we are aware of areas of concern within regions, business units and functional areas.
Employee surveys Between 2002 and 2006 we conducted Global Leadership Surveys every two years to track management views on a range of issues. The next survey will be run in 2009 and will measure managers¶ perceptions of our progress towards achieving our new strategic priorities which were introduced in 2008.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Our plans We are continually reviewing the effectiveness of our communications and how we can improve them. Employees are encouraged to ask questions and comment on the information we provide and the communication channels we use. As technology is updated, it is easier for us to encourage direct communication and discussion with employees. In 2009 we will expand our use of technology, such as social media tools, to encourage greater collaboration and communication across GSK, breaking down traditional communication barriers.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Diversity and inclusion
Corporate Responsibility Report 2008 Diversity and inclusion Approach
Performance & plans
At GSK, we recognise the value that different perspectives and experiences bring to GSK and we aim to recruit a diverse range of employees to our global workforce. We respect all our employees and include talented people in the workforce regardless of race, gender, sexuality, age, religion and belief or disability. We do not require medical testing as a prerequisite for employment. We aim to adopt inclusive work practices that create an environment where employees feel individually and collectively empowered, and can develop and contribute to the business to their full potential. Being a diverse and inclusive business helps GSK to recruit and retain the best people for the job. It also enables us to understand and meet the needs of diverse patients, customers and consumers.
Global diversity policy Our commitment is set out in our global diversity policy. Our Corporate Executive Team endorses the policy and related activities such as our annual Multicultural Marketing and Diversity Awards. All our employees are expected to comply with this policy. Allegations of discrimination are taken extremely seriously, fully investigated and findings acted upon. Each business has diversity champions, employees that promote diversity issues. In the UK and US we have Diversity & Inclusion (D&I) steering committees, made up of human resources managers and line managers with specific responsibility for diversity and inclusion. The committees run diversity awareness campaigns and training sessions. GSK also monitors and reports on gender diversity in management in the UK and US.
Employee networks Employee networks are an important element of our diversity and inclusion programme. They support professional growth and provide a forum where people with similar interests or backgrounds can meet, discuss shared experiences and address any problem areas. This helps engage and empower employees. The networks are an important source of expertise on diversity issues. GSK managers can engage with the networks to improve their understanding of employees from different backgrounds. Networks also help our media and marketing teams understand our diverse customers and stakeholders. GSK has networks for Asian, African American, Hispanic, gay, lesbian, bisexual and transgender employees. We also have networks for mature employees, employees early in their career, women in leadership and veterans. Each network has an executive sponsor who helps to set and achieve goals, obtain resources and promote the network¶s objectives among senior management.
Disability We work to ensure people with disabilities can access the full range of recruitment and career opportunities at GSK. In the UK, we partner with the Employers¶ Forum on Disability and strive to be a µdisability confident¶ organisation. Disability confidence is a concept developed by the Employers¶ Forum to describe companies that create a culture of inclusion, remove barriers to access and make adjustments to enable individuals with disabilities to contribute as employees, customers and partners. We hold the µTwo Ticks¶ symbol from
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
JobCentrePlus, which demonstrates GSK¶s commitment to employing disabled people. Read more information on our approach to diversity and inclusion. Positively managing HIV in the workplace
We do not discriminate against prospective and current employees based on HIV status and do not require testing as a prerequisite for employment. We maintain medical confidentiality at all times. We provide information and training to staff on HIV/AIDS prevention and addressing problems of stigma relating to the disease. We provide HIV/AIDS testing, voluntary counselling and treatment programmes to employees and their families in countries where these are not easily available via government healthcare programmes. We also offer preferentially priced anti-retrovirals or equivalent not-for-profit arrangements to other employers in Sub-Sahara Africa who have their own workplace clinics
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Diversity and inclusion
Corporate Responsibility Report 2008 Diversity and inclusion Approach
Performance & plans
Gender diversity We are pleased that the percentage of women in management has increased incrementally in the last five years. However, there is still a lot of room for improvement. Gender diversity in management 2008 Per cent positions held by women (worldwide)
2004
2005
2006
2007
2008
Corporate Executive Team, senior vice presidents, vice presidents
19
21
22
22
25
Director grade
33
33
34
35
36
Manager grade
38
38
39
40
41
All management positions
35
35
36
37
38
Gender equality in the workplace is affected by many factors, some external to GSK, including the requirements of family life. Our flexible working policies help employees balance the demands of work and home life. They can be particularly beneficial for caring and family responsibilities. For example, we offer part-time working, job sharing and remote working. Read more about our programmes encouraging women in science: Women in Science Events and the Scientific Women¶s Scholarship Programme.
Ethnic diversity In the US, minorities (defined as Blacks, Hispanics, Asians, Pacific Islanders, American Indians and Alaskan natives) made up 20.5 per cent of our workforce in 2008, compared with 20.1 per cent in 2007, 19.8 per cent in 2006 and 19.6 per cent in 2005. In the UK, ethnic minorities accounted for 19.2 per cent of employees, in 2008 compared with 19.1 per cent in 2007, 18.3 per cent in 2006 and 16.8 per cent in 2005. Ethnic minorities accounted for 12.5 per cent of the UK population of England and Wales in 2001, the last UK Census. We use the UK Commission for Racial Equality definition of ethnic minorities. This includes anyone who does not identify themselves as White British, so this means people identified as White Irish, North American and European are included as minorities. We also measure diversity in the UK by counting the number of employees that define themselves as nonwhite. In 2008, 12.1 per cent of employees defined themselves as non-white, compared with 11.8 per cent in 2007, 11.6 per cent in 2006 and 11.0 per cent in 2005. Ethnic minorities (US)
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Ethnic minorities (UK)
Multicultural marketing and diversity awards Our annual Multicultural Marketing and Diversity Awards aim to inspire employees to find creative ways to reach a broader range of potential employees, customers and communities. Awards are given in categories such as employee attraction, development or retention; multicultural marketing and sales; community outreach; and diversity ambassador. The 2008 Awards recognised 13 project teams and five individuals. Award-winning projects included: An initiative that, over four years, increased the representation of diverse subjects in US clinical trials from just under 20 per cent to 35 per cent, slightly higher than the overall US minority population A literacy programme to teach 154 Indian manufacturing employees how to sign their names on official documents instead of using a thumb print Read more in our case study on this literacy programme.
Our plans During 2009 we plan to simplify our approach to diversity and inclusion, ensuring that this maximises employee empowerment.
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Home Responsibility Our people Training and development
Corporate Responsibility Report 2008 Training and development Approach
Performance & plans
Training and development opportunities help employees feel valued and engaged in their work. GSK provides work-related training courses for all employees, and leadership training for managers. These focus on providing people with the right behaviours and expertise for their jobs and the skills needed to apply their knowledge effectively. Our goal is for each individual to achieve their potential and contribute fully to company performance. We conduct regular appraisals to identify training needs and help employees set and achieve development objectives. We operate 360- degree assessments for our top managers to ensure they receive objective feedback on their performance from the employees they manage and colleagues that they work with, as well as their manager. Training is carried out within each business function and online, for example through our µmyLearning¶ intranet site in the US and UK. We also offer project secondments to help employees learn new skills.
Leadership development We identify high-performing employees and potential leaders in each business function through our annual talent management cycle. Managers are accountable for developing talent and successors and this is a top priority for every leader. The process ensures we have the diverse and high-performing talent required to deliver our business strategy and to reflect the global growth of GSK. Talented people participate in leadership programmes and connect with senior management through programmes such as the Chief Executive Forum. Our leadership framework helps employees fulfil their potential, become leaders in their field and contribute fully to our business performance. Specifically, it helps them to: Develop the behaviours that distinguish high-performing leaders. These include innovative thinking, engaging and developing others, leading people and achieving excellence in their work Understand their behaviour, take personal responsibility for their actions and continue to perform with integrity Enhance their expertise, including technical and functional skills and broader knowledge. These contribute directly to GSK¶s overall performance and are likely to be unique to the position, role or function of each employee Effectively use and apply the processes and practices within GSK We also provide extensive health, safety and environment training for our employees.
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Home Responsibility Our people Training and development
Corporate Responsibility Report 2008 Training and development Approach
Performance & plans
The majority of our employees receive an annual performance appraisal through our Performance and Development Planning (PDP) programme. Compliance with this requirement is measured at local level, but we know that more than two-thirds of employees received an appraisal in 2008. The PDP programme assesses how well employees have implemented GSK business principles through their work. The appraisals impact on bonus payments and future career development. In 2008, we focused on embedding our leadership framework. This included the following training initiatives: µHot Topics¶ training which focused on how to lead in times of transformational change. Nearly 1,700 managers and senior leaders attended Workshops to teach GSK leaders about the importance of coaching their staff and techniques for doing so effectively; 138 managers took part in the workshops in 2008 Online development resources available for all English-speaking employees, providing a variety of steps they can take to build leadership skills We also offered over 3,000 learning programmes to all GSK employees via our online learning management system.
Our plans During 2009 our Leadership and Organisation Development function will work to support GSK¶s strategic priorities. Plans include forecasting and delivering the capabilities needed for the future growth and success of GSK. In addition, leadership development will continue as an area of focus, including refining the behaviours necessary for successful leadership and supporting this with prescribed learning and development opportunities and experiences.
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Home Responsibility Our people Reward and recognition
Corporate Responsibility Report 2008 Reward and recognition We offer employees a competitive salary based on industry benchmarks, as well as performance-related incentives and other benefits. This helps us to attract and retain the best people. We particularly reward employees for innovation and good performance and we reward leaders who empower their staff. Our pay strategy for managers is based on a programme called TotalReward that helps us recognise good performance and enables managers to share in GSK¶s success. We use feedback from managers to identify the types of reward that they prefer. Components of TotalReward include: Cash, including salary, bonuses and incentives (including long-term incentives for eligible employees), and recognition awards. Salaries are allocated within defined bands for different employment levels Savings choices such as pension provision and share schemes Lifestyle benefits, for example healthcare, childcare support and employee car ownership programmes TotalReward applies to GSK managers around the world, although the component parts of an employee¶s package will differ by country in accordance with local legislation and best practice.
Share ownership Our share ownership schemes help to create a culture of ownership among our employees. In countries where share ownership opportunities exist, they are open to all employees and there is a high level of participation. For example, in the UK 67 per cent of employees participate in our ShareSave scheme, and 85 per cent in our ShareReward scheme.
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Home Responsibility Our people Health, safety and wellbeing
Corporate Responsibility Report 2008 Health, safety and wellbeing Keeping our employees and contractors healthy and safe is a priority. Our rigorous management system reduces the risk of harm to our employees and helps them stay healthy. It is part of our broader environment, health, safety and sustainability (EHSS) programme. As well as being the right thing to do, this improves business performance by increasing attendance, improving productivity and reducing healthcare and insurance costs.
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Home Responsibility Our people Health safety and wellbeing Health and safety management
Corporate Responsibility Report 2008 Health and safety management We manage health and safety through an integrated environment, health, safety and sustainability (EHSS) management system. This incorporates our EHS and sustainability vision and policy and associated standards. Our EHSS Plan for Excellence includes our strategy for improving EHSS performance up to 2015. We employ health and safety professionals across sites within business units and at the global level to manage health and safety risks across GSK. Read more about our EHSS management system. Our occupational health and safety data is independently assured. Assurance does not include personal health and wellbeing programmes and data.
Audits and performance As part of our overall environment, health, safety and sustainability audit programme, we conduct occupational health and safety audits at our sites every one to four years. The frequency depends on current risks and past performance. We carry out more frequent visits at some sites, based on the degree of risk at the site, its health and safety performance and the issues raised by previous audits. Audit results are presented to the Audit Committee of the Board of Directors. Our occupational health and safety target [link to environmental sustainability/plan for excellence/targets] is to reduce reportable injuries and illnesses by five per cent a year from 2006 to 2010, and to be placed within the top quartile of comparable industry ratings by 2012. We systematically assess and manage occupational health and safety risks and performance. When incidents do happen we identify root causes and take action to prevent reoccurrence. We believe that addressing the causes of incidents will help eliminate risks and hazards, and prevent future occupational injuries and illnesses. In 2008 we audited 31 GSK sites for implementation of occupational health and safety standards as part of our overall environment, health, safety and sustainability audits. The average audit score was 78 per cent which compares to our 2010 target of 82 per cent. Best performance was seen in fire prevention, site management commitment to occupational health and safety, investigation and reporting or injuries and illnesses and emergency planning and response. Sites were generally weakest in resilience and mental wellbeing, control of chemical agents, use of work equipment, risk assessment, permit to work systems, noise control and ergonomics. Auditors found two µcritical findings¶, which indicate a high probability of incidents with potentially serious consequences. The first related to deficiencies in controlling the risk of falls during a construction project and the second was related to the risk of fire from inadequate management of highly flammable liquids. These issues are monitored to ensure that appropriate actions have been taken to mitigate risks and ensure ongoing compliance. In 2008 one of our active pharmaceutical ingredients manufacturing sites was fined 50,000 by the UK regulator, HSE, for a process safety incident that occurred in 2006. A serious explosion occurred at the Irvine, UK site, involving a µplacebo¶ batch used to test plant conditions and controls. Two operators were injured. The event has been thoroughly investigated, learnings shared and improvements made. This was reported in our 2006 Corporate Responsibility report.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
In 2008, a site in the US received a fine of $1,375 from the South Carolina state Occupational Safety and Health Administration (OSHA) for violations of forklift regulations. These concerns have been addressed at the site.
OHSAS 18001 certification Twenty-six of our 78 Pharmaceuticals and Consumer Healthcare manufacturing sites and one Consumer Healthcare R&D site are certified to the international health and safety standard OHSAS 18001. We have set a goal for all manufacturing sites to be jointly certified to OHSAS 18001 and the environmental standard ISO 14001 by the end of 2010. In 2008, three new sites were certified. The certified sites are in Argentina, Australia, Brazil, China, Egypt, France, Germany, India, Japan, Kenya, Mexico, Panama, Philippines, Poland, Saudi Arabia, Spain, Turkey, the US and the UK.
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Home Responsibility Our people Health safety and wellbeing Hazard assessment and communication
Corporate Responsibility Report 2008 Hazard assessment and communication Assessment Understanding the intrinsic hazards of the materials we produce or use in research, development and manufacturing is an important first step to enable us to effectively manage health and safety risks and prevent damage to the environment. Our occupational toxicologists and environmental scientists assess materials hazards throughout product development. Increasingly, we use computer-based modelling and in vitro methods instead of animal tests. We use hazard information to assign occupational and environmental exposure limits that help guide the design of systems used to protect our employees¶ health and to protect the environment from chemical contamination. Our hazard assessments help us meet regulatory requirements such as the new EU Registration, Evaluation and Authorisation of Chemicals (REACH) legislation.
Communication We provide hazard information to enable our employees, contract manufacturing partners and customers to handle and dispose of our materials and products safely. We develop safety data sheets for new materials and products as they progress through the development process. This ensures that health and safety information is readily available to our staff before they handle chemicals and to our customers when the product is launched. We distribute safety data sheets using a web-based system. It provides safety information for nearly 4,500 GSK materials and key manufacturing and process chemicals. It also includes over 2,200 safety data sheets for pharmaceutical, biological and consumer healthcare products. The information is regularly updated and is available in English, French, German, Italian, Portuguese and Spanish. Safety data sheets for our products are available on our website and are also communicated directly to our customers via fax on demand, or through customer response centres.
Safe transport of materials As part of our normal business operations we transport materials that require special handling such as chemicals, biological and radioactive materials, and finished products. We have a network of highly trained employees to oversee transportation-related activities to ensure materials are transported in a safe and effective manner that complies with national and international laws and conventions. This ensures that our employees, the public and the environment are kept safe. We use two systems that support tracking, classification and emergency information for the transportation of chemical, biological and radioactive materials. The HazClass system is available for use by R&D sites. Manufacturing sites use the SAP system to manage transport of their materials and products.
Understanding fire and explosion risks Our in-house fire and explosion laboratory conducts tests to determine fire and explosion properties of materials handled in research and development and manufacturing. This work is primarily driven by the requirements of the EU regulations on explosive atmospheres (Directive 99/92/EC, ATEX 137). When manufacturing sites receive hazard data from laboratories, they undertake risk assessments to design work practices that eliminate or reduce the risk of fires and dust explosions.
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Home Responsibility Our people Health safety and wellbeing Safety programmes
Corporate Responsibility Report 2008 Safety programmes We operate a number of programmes to keep our employees and contractors safe:
Chemical exposure We have rigorous procedures and controls in place to ensure employees involved in developing and manufacturing our products are protected from exposure to chemicals. We have a goal to make 80 per cent of operations involving the handling of hazardous compounds µrespirator free¶ by 2010. This means employees will not need to wear respiratory protective equipment for routine production tasks. Instead, sites will install technology that prevents the release of hazardous compounds into the work environment. For example, we have installed contained powder transfer systems and glove-box technology at our pilot plant facility in Cork, Ireland, and a special containment system at our new penicillin facility in Pakistan. We have also developed a proprietary manufacturing technology which greatly reduces operator exposure to medicines as they are manufactured. Each GSK site monitors air quality to assess exposure to hazardous compounds and implements controls to protect employees and achieve our µrespirator free¶ goal. Our occupational hygienists, employee health staff and engineers work together at site, regional and global levels to reduce employees¶ exposure to chemicals. By the end of 2008 over 40 per cent of operations had achieved a µrespirator free¶ level of engineering control based on at least some occupational hygiene monitoring results. We continue to upgrade engineering controls to achieve µrespirator free¶ levels of control. For situations where engineering controls are not possible, employees will remain protected by appropriate respiratory and other protective equipment.
Process safety Many of our products begin with the formulation and processing of hazardous materials such as flammable solvents and combustible powders. Our scientists look for opportunities to eliminate the use of these hazardous materials through our green chemistry and green technology programmes. Where substitution or elimination is not an option, our process safety programme aims to ensure that safety is built into manufacturing, research and development processes, and that employees receive training to understand risks and implement appropriate controls. Our engineers use an online assessment system to develop safer processes and plant maintenance strategies and to share hazard information and control strategies across GSK. We have reviewed and updated our process safety strategy after two employees were injured in an explosion at our factory in Irvine, UK, in 2006. Using the results of this review, we are continuing to update and integrate our process safety management system (PSMS) into our EHSS management systems at all GSK sites. This includes: A design code containing new engineering standards for process safety Assessments against the new engineering standards, with gap analyses Upgraded risk assessments and remediation processes Process safety indicators Steps to embed process safety in the overall safety culture
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New training and competence programmes and process safety tools We also appointed a new director of process safety.
Safety engineering Our safety engineering programme focuses on improving construction and plant safety and ensuring effective emergency response systems. We have developed safety engineering guides to managing the risk of fire and explosion and to provide guidance on machine guarding and electrical hazards. These web-based guides provide a standardised approach to managing safety risks across GSK. We also ensure that safety is built into and maintained at our sites worldwide through the following programmes: Risk Assessment and Control Processes, Construction Contractor Safety Programme, Capital Project EHS Review Process and our Emergency Response Programmes.
Ergonomics Musculoskeletal illnesses and repetitive strain injuries are some of the leading causes of time away from work. Our Corporate Executive Team has set a target to reduce the number of these illnesses and injuries by five per cent each year through to 2010. Good workplace and job design, known as ergonomics, helps employees to do their jobs effectively while reducing the risk of musculoskeletal illnesses and injuries. There are 70 ergonomic improvement teams working across GSK businesses to assess and manage the ergonomic risks of existing operations and planned projects. Teams include members from areas such as manufacturing quality, safety, health and medical services and those that perform the work itself. Teams work together to identify risks, develop solutions and share best practice globally through a dedicated ergonomics community on our intranet. In addition, over 900 trained facilitators throughout the business help to manage computer-based ergonomic risk assessments for over 30,000 employees. These assessments identify steps to reduce discomfort and injury relating to computer use. Information about ergonomics best practice is also available to employees on our intranet site. These efforts have contributed to: A 4.7 per cent improvement from 2006 to 2008 in ergonomics-related injury and illness. This is short of our target of an annual five percent improvement through to 2010, equivalent to a 10 per cent improvement over 2006 to 2008. In order to meet or exceed our target in 2009, we will increase our effort and resources in this area Cost and productivity gains in manufacturing operations. For example, in 2008 at our Nabha site in India, a manual handling task was improved resulting in simplified work process, reduced risk of injury and reduction in the number of employees needed to perform the task from three people to one person. This allowed the two workers to focus on other tasks while reducing the risk of injury for all workers Improved audit scores through implementation of ergonomic improvement processes. For example, Kuala Lumpur improved its µergonomics management of risks¶ score from 43 per cent to 80 per cent as a result of implementing an ergonomics improvement process, and improved its overall audit score Significant impacts on introduction of new ergonomics improvement teams. For example at our Tianjin facility in China, six major ergonomic improvements initiated by the new team in their first months resulted in a 40 per cent reduction in reports of discomfort/injury and improved morale The GSK ergonomic improvement teams were given special recognition in 2008 by the European Safety and Health Council as part of a Europe wide-focus on improving manual handling Internal recognition of the global ergonomic community team and process as an example of new ways of working at GSK with shared global resources spanning functions, businesses and cultures. The team won an award in our 2008 µCross sector multicultural marketing and diversity awards¶
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Driver safety Our sales representatives spend significant amounts of time driving and are therefore at risk of being involved in road traffic incidents. We aim to reduce this risk as much as possible through our worldwide driver safety programme. This includes instructions and guidelines on driver training, vehicle selection, risk assessment and accident reporting. We have a motorbike rider safety manual for employees in countries where we provide motorbikes or scooters. Around three-quarters of GSK¶s commercial businesses have extensive driver safety programmes in place, including driving licence checks, guidance on the use of mobile phones, safety training and tracking and reporting incidents. We plan to extend these to our other sites. The most common cause of fatalities and serious injuries remains driving accidents. In 2008, 15.9 per cent of the injuries with lost time were due to motor vehicle accidents, as were 19.7 per cent of the injuries without lost time. In 2008, two road traffic accidents caused the death of two of our employees. See µFatalities and serious injuries¶. Defibrillator programme
In 2007 and 2008 six people were resuscitated using automated external defibrillators (AEDs). An AED is a safe and easy to use portable medical device that analyses heart rhythm and delivers electric shocks to victims of ventricular fibrillation in order to restore the victim¶s heart rhythm to normal. We began expanding the number of sites with AEDs when they were used in saving several lives in the US and UK in 2005 and 2006. Key personnel are trained to use AEDs in emergency situations and the equipment is installed at an estimated 100 GSK sites in Belgium, Brazil, Canada, Egypt, France, Germany, India, Italy, Japan, Mexico, Puerto Rico, Singapore, South Africa, Spain and US. We used a risk assessment to decide which sites should have AEDs, based on factors including heart disease risks among employees, hazards on site such as chemicals or energised circuits that could cause cardiac arrest, and ambulance response times.
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Home Responsibility Our people Health safety and wellbeing Health and wellbeing programmes
Corporate Responsibility Report 2008 Health and wellbeing programmes GSK offers programmes to boost employee health and wellbeing and to create and sustain energy and engagement with their work. This in turn helps improve our business performance. GSK helps improve employee wellbeing by offering flexible working options and health and wellbeing initiatives. These include health risk appraisals, screening for diabetes and hypertension, smoking control support, fitness and nutritional advice, and immunisations. Our prevention and screening initiatives focus on the leading causes of illness and disability among our employees which include depression, non-workrelated injuries, heart disease, stroke and respiratory infections. Increasingly we are also focusing on ways to encourage team and personal energy and resilience in times of high pressure. Many of our employee health and wellbeing programmes have won national awards for excellence in 2008, such as the Platinum Awards from the National Business Group on Health (NBGH) in the US and the Health Promotion Board in Singapore for our team resilience programme. We received an award in 2008 from the NBGH for innovation and commitment to providing lifestyle improvement programmes designed to improve healthier lifestyles for our employees.
Energy and resilience We define resilience to describe the skills and traits necessary for success in a high-pressure working environment. These skills and behaviours also help prevent mental illness due to stress, a leading cause of ill health and disability at work. Energy for Performance When employees have energy they can focus better and perform their tasks more efficiently. The Energy for Performance (E4P) programme is designed to boost energy levels and help employees invest energy in the right way, at work and at home. Uptake was good: 1,626 employees participated in E4P workshops in 2008. Over 3,000 employees from over 30 countries had attended E4P workshops by the end of 2008. Over 80 per cent have reported significant improvement in their physical and mental performance and emotional energy. Participants found that their performance improvements persisted for at least 12 months after the workshop. Personal resilience We run workshops for employees who want to enhance and build their personal resilience. Focusing on improving work and home life, the programme aims to help employees increase their focus, energy and confidence while also helping to reduce tension, anxiety and fatigue. Since the programme started in 2007 over 1,100 employees have participated in the programme Team resilience Healthy, collaborative and motivated teams are critical to business success. The Team Resilience programme helps employees and their managers to identify sources of pressure on their teams, such as process complexity or lack of workplace flexibility or accountability. Teams then work together to agree action plans to address their concerns. The programme helps teams take more control of their work, and eliminate or manage the sources of pressure that can lead to ill health or
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inefficiency. Since the programme began in 2003 it has been completed by teams in 51 countries, comprising 26,500 employees by the end of 2008. Participants report an 80 per cent reduction in workplace pressures, 25 per cent drop in work-life conflict and a 21 per cent increase in satisfaction with GSK as an employer.
Wellbeing and work-life balance GSK offers programmes to improve the health of employees and their families. We find this increases employee commitment and productivity and reduces absenteeism and the cost of ill health. Support varies between countries and according to local needs. Our sites use public health and GSK data to identify high risk areas and investments that lead to significant health and cost improvements. Programmes often include benefits such as on-site health and fitness centres, flexible working arrangements, immunisations, regular medical check-ups, assistance to stop smoking, disease screening and management, family support services and health education. We also assist employees suffering from chronic diseases to ensure they have access to the correct long-term treatment and support. Our programmes help local healthcare services by focusing on health education, prevention awareness and management of current conditions. We have created a network of GSK employee health professionals to share health and wellbeing best practice. GSK also supports key public health efforts such as World AIDS Day, the World Health Organization¶s Health Day, Tobacco Free Day and Global Handwashing Day.
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Home Responsibility Our people Health safety and wellbeing Health and business continuity
Corporate Responsibility Report 2008 Health and business continuity We have developed contingency plans to protect our employees and business in the event of natural disasters, man-made emergencies or a flu pandemic. These plans aim to ensure that our business can continue to function and we can continue to supply critical medicines to patients. We have also developed and implemented programmes to protect more than 435,000 staff, their dependants and key complementary workers in over 130 countries in the event of a pandemic. We offer employees annual seasonal flu vaccination in 95 per cent of our markets, as well as travel health programmes. We stockpile multiple antiviral medicines that can be used to prevent or treat pandemic flu. From 2009 this will include pre-pandemic vaccines, which can be administered before a pandemic has started, and a pandemic flu vaccine which will be available six months after the exact pandemic flu strain has been identified. In the event of an outbreak we will implement special rules to prevent the disease spreading among our workforce. For example, non-essential services will close, face-to-face meetings will not be held and special cleaning and personal protective programmes will be implemented. We will restrict business travel and access to GSK sites and employees will be encouraged to work from home. We have developed a special website, accessible on our intranet and externally, that acts as a single source for all global and local flu information across GSK.
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Home Responsibility Our people Health safety and wellbeing Training and awareness
Corporate Responsibility Report 2008 Training and awareness Training helps to create a workplace culture where occupational health and safety is taken seriously. Employees who are responsible for managing occupational health and safety issues at sites and business units receive regular training and in turn instruct employees about safe working. We give training on our environment, health, safety and sustainability (EHSS) standards, as well as programmes such as process safety, chemical exposure protection, identifying risk, auditing and ergonomics. Sites develop and conduct training based on local needs and capabilities. Some use our internal learning tools, commercially available training programmes or locally available government or university sponsored training programmes. We have developed a training framework that identifies gaps in employees¶ knowledge of health and safety and provides in-house and external training courses. Our health and safety professionals share knowledge and best practice via teleconferences, intranet communities, training programmes and discussion forums. We raise awareness about employee health and safety issues through: Employee bulletins Announcements on our myEHS Community intranet sites The CEO¶s EHS Excellence awards programme Health and Safety Week, held in October to coincide with the European Health and Safety week. The event encourages employees to address potential risks at work and at home. Over 13,000 employees from 76 sites in 26 countries took part in the 2008 Health and Safety week activities. Read more about training on environment, health and safety issues. Health and safety: Worthing EHS challenge competition
In 2008, GSK¶s penicillin manufacturing facility in Worthing, UK, ran four competitions to improve employees¶ knowledge of EHS issues. Each month, the EHS team sent five questions to all staff on topics such as fire and evacuation, first aid, how to respond to penicillin exposure and the site¶s EHS targets. The following month, the questions were posed to five employees from each work unit and points were awarded for correct responses. The team published a league table each month and every quarter the winning team was awarded 1,000 for the charity of their choice. In total, competition winners gave 4,000 to charity in 2008. Following its success at Worthing, the competition was introduced at 12 more sites in the UK, France, China and India in 2008. This project won second place in the 2008 CEO¶s EHS excellence awards in the Safety Initiative category.
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Home Responsibility Our people Health, safety and wellbeing Performance
Corporate Responsibility Report 2008 Performance Performance
Data table
Injury and illness rates Our main health and safety measure is the reportable injury and illness rate. We also measure the number of injuries and illnesses that result in lost days, as well as the number of days lost from these injuries and illnesses. This provides an indication of the severity of the incidents, although it is only a rough guide. We have set targets to improve injury and illness rates. Injury and illness targets Injury and illness target
Progress 2006 to 2008
To reduce the reportable injury and illness rate by 5 per cent each year to the end of 2010
Improved 16 per cent
To reduce the reportable musculoskeletal illness and injury rate by 5 per cent each year to the end of 2010
Improved 4.7 per cent
To rank in the first quartile of an industry benchmark group
Improved ranking by one place, remaining in third quartile
Data cover GSK employees and contract workers who we directly supervise. We report separately data for contractors who work on GSK sites but supervise their own staff in the data table . Contractors¶ data are not externally verified. Injury and illness data are collected from all 79 of our Pharmaceutical, Consumer Healthcare and Nutritionals manufacturing sites, 14 of our 15 vaccines sites (one site is not yet in operation), 29 of 31 Pharmaceutical and Consumer Healthcare research and development sites (two sites are considered too new to start reporting), the US and UK headquarters sites, eighteen offices and sales groups with more than one million hours worked, and 46 of the smaller offices and distribution centres. In 2008 some sales and office sites did not report injury and illness data. We estimate that approximately three per cent of the data are missing due to one large sales group that reported injury and illness in 2007 but not in 2008. Injury and illness rates
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The reportable injury and illness rate continues to improve at an average rate of more than five per cent per year across GSK. In 2008 there were 847 injuries and 284 illnesses, a total reportable injury and illness rate of 0.6 reportable injuries and illnesses per 100,000 hours worked. This was an improvement of 16 per cent from the 2006 baseline, exceeding our target. The reportable ergonomics-related injury and illness rate has improved 4.7 percent from 2006-2008. This is short of our target of an annual five percent improvement through to 2010, equivalent to a 10 per cent improvement over 2006 to 2008. In order to meet or exceed our target in 2009, we will increase our effort and resources in this area. In our Pharmaceutical and Consumer Healthcare manufacturing organisation, where injury and illness rates are included in managers¶ objectives, the rate has improved 27 per cent from 2006 to 2008. Machinery safety projects at many manufacturing sites, and projects encouraging employee safety awareness, are examples of initiatives contributing to this improvement. The rate of lost-time injuries and illnesses has improved only 3.3 per cent from 2006 through 2008 to 0.33 lost-time injuries and illnesses per 100,000 hours worked. However, days lost per 100,000 hours has improved 11.3 per cent indicating a lower number of days lost per incident, possibly an indicator of less severe injuries and illnesses. In 2006 and 2007 our injury and illness performance places us in the third quartile of a benchmark industry group, which means we need to improve. Our target is to be in the top quartile of comparable industry ratings by 2012. Read a case study on how a site has improved safety during shutdown.
SGS verified
Injury and illness causes The most frequent types of incident overall are ergonomic, mainly musculoskeletal illnesses and repetitive strain injuries, accounting for 27.7 per cent of all injuries and illnesses. We continue to expand our ergonomics programmes to address this cause of injury and illness The most frequent reportable injuries are slips, trips and falls, and account for 19.3 per cent of all injuries and illnesses in 2008. A team is being assigned to look into ways to address this type of injury Injuries due to machinery accounted for 17.5 per cent of all injuries and illnesses. Our manufacturing sites are renewing their focus on machine safety to continue improvements in this area. Road traffic accidents accounted for 13.0 per cent of all injuries and illnesses in 2008 and two fatalities detailed below.Driver safety is a continuing area of focus especially in the sales force.
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Mental ill health accounts for 3.8 per cent of all injuries and illnesses but these cases result in the highest number of days lost at over 76 days per case on average or 21.5 per cent of the total number of days lost for all injuries and illnesses. This is being addressed by our resilience programme.
SGS verified
Fatalities and serious injuries Employee fatalities Five year trend in employee fatalities 2008
2
2007
2
2006
3
2005
1
2004
2
2003
5
2002
3
In 2008, one of our sales employees was killed in a fatal road traffic accident in the Philippines. Three passengers were also killed in the accident. One of our sales employees in India was killed in 2008 when he fell from his bicycle into the path of an oncoming motorized three-wheeler when the front tire of his bicycle was punctured. Two GSK employees were seriously injured in another road traffic accident in India in 2008 when the vehicle in which they were being transported by a contract driver struck another vehicle, killing two people. In 2008, there were five amputations and a serious finger injury due to accidents with moving machinery. Three employees had amputations of fingers or finger tips, one employee sustained amputation of a foot and one contract worker had an amputation of his forearm. An employee in the US was injured when his foot was caught between powered rollers. Reconstructive surgery proved unsuccessful and the foot had to be amputated A contract worker in India reached into a clothes dryer while it was rotating to remove an article of clothing, resulting in amputation of his forearm An employee in South Africa slipped on a wet floor and grabbed a piece of equipment to keep from falling. His weight caused a valve to close on his hand amputating his finger at the top joint and badly crushing two fingers. The severed finger was re-attached, but the crushed fingers could not be saved and were amputated An engineering mechanic in Pakistan placed his hand on an operating piece of machinery. A tube holder struck a finger inflicting severe damage resulting in amputation An employee in the US was clearing a jam on an assembly/packing machine and placed her hand on a part of the machine that closed on her finger amputating the finger tip A fitter in Australia suffered serious lacerations to his finger while installing a cutter on a blister pack machine. Hospital treatment was required but amputation was avoided All of these amputations resulted in renewed emphasis on machine guarding programmes at these sites.
SGS verified
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Injury and illness milestones All GSK operations strive to work without experiencing any lost-time injuries or illnesses. We issue certificates signed by business heads to sites that reach one million hours worked without a lost-time injury or illness. Sites that reach two or more million hours worked without a lost-time injury or illness are awarded certificates signed by our Chief Executive Officer. Small sites that do not attain the level of one million hours worked in a three- year period can obtain a certificate for three or more years worked without a lost-time injury or illness. Milestones achieved in 2008 for hours worked without a lost time injury or illness: 1 million hours: 4 sites 2 million hours: 1 site 3 million hours: 4 sites 4 million hours: 1 site 5 million hours: 1 site 3 years: 1 site 5 years: 2 sites Back to top
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Home Responsibility Our people Health, safety and wellbeing Performance
Corporate Responsibility Report 2008 Performance Performance
Data table
Metric
2001
2005
2006
2007
2008
191.1
196.6
195.4
196.4
187.7
5
1
3
2
2
751
552
565
585
522
16,268
11,610
11,291
11,412
10,706
133
81
98
97
94
Calendar days lost ± illnesses 3
5,304
3,034
5,454
4,135
3,564
Number of injuries without lost time 4
1,079
464
448
393
325
Number of illnesses without lost time 4
315
319
287
260
190
Reportable injury and illness rate
0.72
0.72
0.72
0.68
0.60
Reportable ergonomic injury and illness rate
0.20
0.16
0.18
0.18
0.17
Lost-time injury and illness rate
0.31
.032
0.34
0.35
0.33
17.0
22.8
22.9
26.1
22.0
Fatalities
0
2
0
2
0
Number of injuries and illnesses with lost time
69
98
89
59
74
Calendar days lost
754
1,575
968
924
708
275
375
400
208
Injury and illness ± GSK employees 1 Hours worked (millions) Fatalities Number of injuries with lost time 2 Calendar days lost ± injuries 3 Number of illnesses with lost time 2
Injury and illness ± non-GSK employees Hours worked (million)
Number of injuries and illnesses without lost time
1. The occupational health and safety data cover both our employees and contract workers who are directly supervised by GSK employees. We report a snapshot of injury and illness performance for the year. Cases may be added after the end of the year so prior years may change 2. Lost-time injuries and illnesses are work-related injuries and illnesses that are serious enough to result in one or more days away from work
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3. Lost calendar days are the calendar days, including weekends which employees could not work because of work-related injuries and illnesses. This helps to provide a measure of the severity of injuries and illnesses 4. Reportable injuries and illnesses without lost time are incidents that did not result in time away from work (lost time). They are more serious than first aid but not serious enough to result in lost time
SGS verified
Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Case studies
Corporate Responsibility Report 2008 Case studies Diversity and inclusion Women in Science Event We have created a global programme within GSK R&D which encourages and celebrates women in science, the Women In Science Event (WISE). The programme started in 2004 in the UK, bringing women scientists together for a day-long event for networking, education and knowledge-sharing opportunities and has since developed in scope and attendance. In 2007 the annual event was held simultaneously at our sites in Stevenage and North Carolina, with a series of speakers, workshops and simultaneous broadcast of the keynote speaker, an internationally renowned female scientist, to both sites. In 2008 we held events in the UK and at two US sites in North Carolina and Delaware, with a keynote speaker and networking opportunities. We plan hold a further event in late 2009. Additional speaking and networking events are arranged throughout the year in the UK and US, featuring leading female scientists from GSK. Scientific Women¶s Scholarship programme The Scientific Women¶s Scholarship programme has been in place since 1993. This programme has offered a unique combination of scholarships and mentor relationships with professional women scientists. Supported by an endowment fund, the programme is open to 29 US colleges and universities. In 2008, 58 women scholars were selected to participate in the programme with GSK in Research Triangle Park, North Carolina. Fifty-five GSK mentors worked with the scholars to pass on their dedication, energy and passion for science to this new generation of students. The scholars are paired with professional women scientists at GSK who serve as their mentors. These women take the scholars under their wing, provide them with expert advice and share their experiences and lessons learned over the years. GSK volunteer mentors also work to secure internship funding and opportunities for their scholars. The internships offer insight into careers and give the scholars hands-on experience in the pharmaceutical industry. Supporting adult literacy Our manufacturing sites in Nabha and Rajamundy, India, are taking action to improve literacy rates among their employees. At the beginning of 2007, around ten per cent of workers could not read or write and had to use a thumb print instead of signing their name. The sites set a goal for all employees to be able to sign their name. Employees at the Nabha factory took nearly 10,000 hours of training in total, including sessions on how to read and write in Punjabi and English. As a result of the initiative, 154 people learned to read and write and all employees are now able to sign their name. Sessions also included areas such as family relations, AIDS awareness, good health practices and
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
domestic safety and budgeting. The project received an honourable mention in the Employee Attraction, Development and Retention category at the 2008 Multicultural Marketing and Diversity Awards.
Occupational health and safety Contractor competition improves safety during shutdown GSK¶s Slough site, which makes Lucozade and Horlicks powders, holds an annual shutdown to clean and maintain manufacturing equipment. The site¶s EHS team developed a programme to reduce the number of accidents occurring during the shutdown, a time of increased risk to employees and contractors when they undertake non-routine engineering activities in a short period of time. The team reviewed the log of accidents and near-misses from previous shutdowns, and held briefing meetings with supervisors and contractors to raise awareness of risks. It then ran a competition to identify and reward contractors with the best safety performance. The initiative has contributed to a 70% reduction in minor accidents during shutdown, and there have been no reportable incidents since the competition began in 2007. This project won third place in the 2008 CEO¶s EHS excellence awards in the Safety Initiative category.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our people Q&As
Corporate Responsibility Report 2008 Q&As Here we respond to questions raised by our stakeholders. As you reduce your workforce, how will you ensure that your remaining employees are not faced with additional stress in their jobs? We recognise that stress at work is an important issue. We have established programmes to help individuals and teams deal with stress, and offer other support such as on-site health and fitness centres, flexible working arrangements, family support services and health education. GSK aims to simplify its operating model and create a culture of individual empowerment, where each employee takes responsibility for his or her own work. We are simplifying how we work by removing processes and structures. This reduces the amount of work there is to do in some areas, and as a result fewer people are required. Empowering individuals to make decisions and carry out work without layers of bureaucracy will support this. How will your Operational Excellence programme affect employees? Regrettably, our Operational Excellence programme will result in job losses. We will do everything that we can to support affected employees including providing a competitive severance package and providing outplacement support such as assistance in identifying alternative employment, career counselling and retraining. We will also work hard to ensure the programme does not have a negative impact on the morale of other staff. We have produced a guide for managers with information on how to support employees during the uncertainty, anxiety and stress encountered during major organisational change. Why are there still relatively few women in senior management at GSK? We are pleased that the percentage of women in management has increased incrementally over the last four years. However, we recognise that there is still room for improvement, especially in senior management positions and in roles within historically male-dominated disciplines such as science and engineering. We aim to attract more women to GSK and to support the career development of existing employees through our flexible working programmes. These help employees balance the demands of their personal and professional lives. We also have diversity champions in each business unit as well as employee networks which support career development for women and minority groups at GSK. Your health and safety performance is below the industry average. What needs to improve? We know we need to improve our performance in this area. In 2008, an assessment project identified ergonomics and attitudes to health and safety in the workplace as among the main causes of injuries and illnesses. We will target our awareness and training programmes based on these results. During the year, we also launched a toolkit to help sites assess their risks and identify interventions. This has been adopted by our Pharmaceutical manufacturing business and behaviour-based safety programmes are now planned in all sites. What progress have you made toward your µrespirator-free¶ target? Results of baseline monitoring of the level of exposure to chemicals in the workplace are being used to define where new and upgraded engineering controls are needed to meet the target for employees in 80% of
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
operations to be able to work without needing to wear respiratory protection. We have reached 42% of operations that have achieved this level of engineering control pending completion of full verification monitoring. We continue to upgrade engineering controls to achieve µrespirator free¶ levels of control but for situations where engineering controls are not possible we will make sure appropriate respiratory protective equipment is used.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Human rights
Corporate Responsibility Report 2008 Human rights We are committed to upholding the UN Universal Declaration of Human Rights, the OECD Guidelines for Multi-National Enterprises and the core labour standards set out by the International Labour Organization. We are a signatory to the UN Global Compact, a voluntary global standard on human rights, labour, the environment and anti-corruption. We believe that governments have a responsibility to define and enforce a legal framework for human rights in accordance with international laws and agreements, such as the Universal Declaration of Human Rights. Businesses also have responsibilities. We work hard to uphold human rights within our sphere of influence, which includes employees, suppliers, communities and society. We have most direct control over human rights in our own operations and can also influence our supply chain and wider society. As a marketer of medicines, we strive to make them as widely available as possible while running our business in a sustainable way. High standards of human rights are important to GSK because they: Help us get the best from our employees Support our relationships with communities near our sites Ensure supplier contracts run smoothly and provide a reliable supply of high-quality products Protect our reputation Human rights are relevant to many of the issues covered in this report. This section gives an overview of our approach. More information on GSK and human rights
See the human rights clauses included in our contracts with suppliers Read more about our supply chain Read about our efforts to improve access to medicines Read about our investment in local communities Read about our employment practices Read our position statement on the Convention on Biological Diversity
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Home Responsibility Human rights Employees
Corporate Responsibility Report 2008 Employees Our employment standards on issues such as diversity, equal opportunities and health and safety protect employees¶ human rights. As an employer we are: Committed to providing a fair salary and good employment conditions Committed to providing a healthy, safe and secure workplace for all employees and contractors Opposed to discrimination at work and committed to promoting respect for diversitys Committed to promoting the personal development and dignity of every employee Respectful of employees¶ right to join an independent trade union and freedom of association Opposed to all forms of slavery and exploitative child labour and will work with appropriate partners to address this problem responsibly wherever we encounter it. Employees can report any concerns to their supervisor or line manager, to human resources or to our ethics and compliance office. They can also use our Global Confidential Reporting line. Read more about our employment practices.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Human rights Suppliers
Corporate Responsibility Report 2008 Suppliers As a buyer of raw materials, manufactured goods and services around the world, we require all our suppliers, contractors and business partners to meet the same standards on human rights as GSK. We will not knowingly use suppliers who are responsible for human rights infringements. We conduct regular audits of existing suppliers and only engage new suppliers that meet our expectations. Human rights clauses are included in our contracts. We consider human rights issues during routine interactions with critical suppliers (contract manufacturers and suppliers that present the greatest risk to GSK in one or more key risk areas). EHS audits of potential new and existing critical suppliers also include questions which help us identify potential breaches of the human rights clauses included in supplier contracts. Suppliers are asked for information on policies and practices relating to: Age limits for employees Discrimination against employees and the local population Prevention of abuse of individuals Wages, benefits and working hours (whether they meet the legal minimum) Rights for workers to organise and recognition of worker organisations These questions do not contribute to the EHS audit score, but may be a reason not to progress business with a supplier. Read more about our supply chain.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Human rights Communities
Corporate Responsibility Report 2008 Communities We respect and promote the rights of all those in the communities near our operations. For example:
Local communities GSK aims to have good relationships with all the communities around our sites and to operate in ways that do not infringe their human rights. We seek to minimise our impacts on the local environment and operate our sites safely. We aim to bring social and economic benefits to areas where we have a presence. Read more about our investment in local communities
UN Convention on Biological Diversity (CBD) The Convention on Biological Diversity provides a framework for the conservation and sustainable use of biodiversity. It also promotes fair and equitable sharing of the benefits arising from the use of genetic resources. GSK supports the CBD¶s role. We are not currently involved in any bioprospecting activity. As a result, we have no access and benefitsharing agreements in place. It is possible that in future we may undertake development work using natural genetic resources indigenous to a particular country. In that instance, access to those resources would be obtained in accordance with the CBD, as reflected in local laws. We would ensure that relevant parties received agreed benefits from the use of the resources, for example monetary payments. Read our position statement on the Convention on Biological Diversity Read our position on protecting biodiversity.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Human rights Society
Corporate Responsibility Report 2008 Society The UN Declaration of Human Rights states that µeveryone has the right to a standard of living adequate for the health and well-being of himself and of his family, including medical care¶. Improving healthcare is one of the greatest challenges we face, particularly in the developing world. GSK contributes to healthcare in the developing world by discovering new treatments and vaccines. We also make a wide range of our products more affordable in developing countries through preferential pricing and voluntary licence agreements with generic manufacturers. We engage with governments, multilateral agencies, NGOs and other pharmaceutical companies to help improve access to medicines. Read more about our efforts to improve access to medicines and our community investment initiatives.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Human rights Activities in sensitive countries
Corporate Responsibility Report 2008 Activities in sensitive countries Some stakeholders are concerned about GSK¶s business activity in countries with poor human rights records, such as Burma (Myanmar), North Korea and Sudan. We share the UN¶s belief (see box) that people should not be denied access to medicines because of the regime operating in their country. We aim to provide medicines and vaccines in all countries that need and wish to purchase them. We observe any trading controls required by law in the countries where we operate. In many nations our long-standing commitment and presence pre-date their oppressive regimes and the subsequent introduction of measures such as trade embargoes. During periods of government-imposed trade embargoes, we have continued operations (subject to any specific legal restrictions) due to the need for our products. In sensitive countries, as in all countries where we operate, we support and are committed to upholding the Universal Declaration of Human Rights and the core standards set out by the International Labour Organization. We observe all local laws and regulations. UN statement on the right to the highest attainable standard of health
Paragraphs relating to access to medicines in sensitive countries: Paragraph 12: µHealth facilities goods and services must be accessible to everyone without discrimination, within the jurisdiction of the State party.¶ Paragraph 41: µParties should refrain at all times from imposing embargoes or similar measures restricting the supply of another State with adequate medicines and medical equipment. Restrictions on such goods should never be used as an instrument of political and economic pressure¶. Paragraph 42: µWhile only States are parties to the Covenant and thus ultimately accountable for compliance with it, all members of society - individuals, including health professionals, families, local communities, intergovernmental and non-governmental organizations, civil society organizations, as well as the private business sector - have responsibilities regarding the realization of the right to health. State parties should therefore provide an environment which facilitates the discharge of these responsibilities.¶ Read the full UN statement for the right to the highest attainable standard of health.
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Home Responsibility Public policy and patient advocacy
Corporate Responsibility Report 2008 Public policy and patient advocacy The pharmaceutical industry is highly regulated. Government policy and legislation can have a significant impact on our business so it is important that we engage with governments and other stakeholders in the legislative and policy process. Through our public policy activity we work towards legislation and policy that encourage scientific innovation and balance the interests of business with those of other stakeholders. We also work with patient groups to help give their members a voice in the healthcare debate. We believe that we conduct our advocacy work responsibly and make a valuable contribution to the debate on public policy issues that impact our business, particularly those relating to research and development, the use of pharmaceuticals and healthcare. We aim to increase stakeholder trust in GSK and, by being transparent about our lobbying and public policy work, to address concerns from some stakeholders that the pharmaceutical industry has too strong an influence over governments. We publish our annual public policy activity on this website and report on our memberships of trade associations, our political contributions and US lobbying expenditures. We also publish information on our work with patient groups, including details of the funding we provide. We provide information on our approach to working with doctors and healthcare professionals in the Research practices and Ethical conduct sections of this website. Back to top
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Home Responsibility Public policy and patient advocacy Our approach to external affairs
Corporate Responsibility Report 2008 Our approach to external affairs Employees involved in public policy work must abide by our Employee Guide to Business Conduct which is based on three principles: Partnership: we are committed to working with governments and regulatory authorities in a constructive way Communication: as well as giving our views, we take on board any concerns from external audiences. This enables us to assess and improve our business practices Integrity: we base our public policy work on research, analysis and facts. We respect other opinions and look for constructive solutions. All of our external affairs work must be in line with our Code of Conduct and other relevant policies including those related to competition law, preventing corrupt practices and political contributions We have external affairs teams in our major regions who monitor proposed legislative reforms and policy developments. They meet regularly with government officials and other stakeholders, for example multilateral organisations and NGOs, to explain our views on a range of public policy issues. We tailor our approach to suit different cultures and political traditions in the countries where we engage in the public policy process, while ensuring that our position in these discussions is fully consistent with our public policy statements. We ensure that the standards set out in our Guide to Business Conduct are applied globally. Lobbying on issues affecting the whole pharmaceutical industry is sometimes conducted through trade associations. We may also hire professional lobbyists to support our public policy work. We have a Political Contributions Policy governing our contributions to political candidates and parties.
Trade associations GSK is a member of many trade and industry organisations, including: Association of the British Pharmaceutical Industry (ABPI) BioIndustry Association (BIA) Biotechnology Industry Organization (BIO) British Pharma Group (BPG) Confederation of British Industry (CBI) European Federation of Pharmaceutical Industries (EFPIA) International Chamber of Commerce (ICC) Intellectual Property Owners Association (IPO) International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Japan Pharmaceutical Manufacturers Association (JPMA) Organisation of Pharmaceutical Producers of India (OPPI) Organization For International Investment (OFII) Pharmaceutical Research and Manufacturers of America (PhRMA) It is important that any lobbying conducted through trade associations reflects our policies and values. We work with other members to help set policies and may also attend lobbying meetings with governments and other stakeholders.
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Sometimes we do not share the same views on a particular issue as other members of a trade association. If a trade association adopts a public policy position that we do not agree with, we will not participate in advocacy activity related to that subject. Senior GSK managers sit on the boards of the majority of industry trade associations of which we are members and raise any concerns we may have about a particular advocacy position. Back to top
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Home Responsibility Public policy and patient advocacy Public policy activity in 2008
Corporate Responsibility Report 2008 Public policy activity in 2008 We engage with governments and other stakeholders on a wide range of issues that affect our industry. These are some of the key issues we engaged on during 2008: Access to healthcare and disease prevention Research practices Patient safety Intellectual property Pricing and competitiveness We publish our position on key issues relating to corporate responsibility, including: Access to medicines in developing countries Research and development Intellectual property The environment Public health Competitiveness Pricing, reimbursement and market access We are happy to discuss our position on these or any other issues with legitimate parties. Contact our corporate responsibility team at [email protected]. Back to top
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Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on healthcare and disease prevention
Corporate Responsibility Report 2008 Advocacy on healthcare and disease prevention Global activity Safeguarding timely and unrestricted access to influenza viruses Organisations engaged: World Health Organization (WHO), key developed and developing country governments (including countries affected by the H5N1 strain), EU institutions Industry associations involved: EFPIA (EVM), IFPMA (IVS), PhRMA GSK position: The influenza virus is very unstable and can mutate quickly. Governments must remain vigilant to the emergence of new strains of the virus and must share virus strains freely with other governments. The free sharing of viruses is in the best interests of global public health as it enables governments to develop vaccines which may prevent an influenza pandemic. The WHO¶s Global Influenza Surveillance Network recommends the content for influenza vaccines twice a year and will act as a global alert mechanism in the event of a pandemic. The international community should unconditionally support the Network, which relies on receiving information on virus strains from governments. Despite the importance of timely and unrestricted access to viruses, Indonesia stopped sharing influenza viruses with the WHO in 2007 insisting on µaccess and benefits¶ in exchange for viruses. The international community ± including the vaccine industry ± spent much of 2008 finding a way to help developing countries prepare for a pandemic. Some progress was made towards agreeing an effective solution at the InterGovernmental Meeting in Geneva in December 2008. GSK is hopeful that a solution that will ensure speedy access to the pandemic virus while assuring developing countries of the support they require to secure access to pre-pandemic and pandemic vaccines will be agreed at the next IGM in May 2009.
US activity Investment in chronic disease prevention and treatment Organisations engaged: US Department of Health and Human Services, Office of the First Lady, US Congress, White House, state legislators, Governors¶ Offices, various state health agencies Industry associations involved: PhRMA GSK position: Chronic diseases such as diabetes, heart disease and lung disease account for threequarters of healthcare spending. Relatively little is invested in prevention even though many chronic diseases and their costly complications are preventable and increasingly manageable. We are advocating a three-part approach to achieving lower-cost, higher-quality healthcare: increasing prevention, improving treatment, and accelerating research into better treatments for chronic disease. Healthcare providers need incentives to promote preventative services that address major causes of chronic disease such as obesity and smoking. Healthcare policy needs reform to better encourage and reward medical research into improved treatments for costly, unmet medical needs such as Alzheimer¶s disease. Preventing and better managing chronic diseases will reduce overall healthcare costs in the long term. Supporting a petition to protect Americans from fraudulent weight loss claims Organisations engaged: US Food and Drug Administration Industry associations involved: None. See below for the healthcare associations involved.
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GSK position: In the US, two-thirds of adults are overweight or obese, increasing their risk of illnesses such as cancer, heart disease and type 2 diabetes. There are dozens of dietary supplements on the market in the US which manufacturers claim can help people to lose weight. Most of these claims are not reviewed by the Food and Drug Administration (FDA) and are not supported by credible scientific evidence. Ineffective weight loss products can prevent people getting the support they need to lose weight. The US Federal Trade Commission¶s Consumer Fraud Survey recently highlighted that there were more victims of fraudulent weight-loss products, 4.8 million American consumers, than any of the other frauds covered by the survey. GSK manufactures alli, the only over-the-counter weight loss product that has gained FDA approval for safety and efficacy. In April 2008, GSK and three research and advocacy organisations (the American Dietetic Association, the Obesity Society and Shaping America¶s Health) submitted a citizen¶s petition to the FDA, asking it to provide greater protection for Americans from fraudulent weight loss claims. The petition requests that the FDA treats weight loss claims in the same way as unsubstantiated claims of efficacy against disease, which are not permitted under the Dietary Supplement Health and Education Act. The petition calls for the FDA to require rigorous scientific evidence for any such claims. It also aims to raise awareness and educate the public about the issue of fraudulent weight loss products. In a separate development, in January 2009 the FDA demanded the recall of a large number of weight-loss supplement products and warned a number of companies that they may be liable for criminal charges. Among the FDA¶s complaints against 69 supplement products in the US was the illegal inclusion of regulated, unapproved or withdrawn prescription pharmaceuticals, including sibutramine and rimonabant (weight loss), phenytoin (anti-seizure) and phenolphthalein (laxative, previously withdrawn by the FDA due to carcinogenicity). GSK supports and will continue to work with the FDA to help protect the public from false and unsubstantiated weight loss claims and possibly unsafe products.
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Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on research practices
Corporate Responsibility Report 2008 Advocacy on research practices We regularly engage with policy makers and other stakeholders on issues relating to research practices and the research environment. Read more about research practices.
Global activity Advocacy on revisions to the Declaration of Helsinki Organisations engaged: World Medical Association, American Medical Association Industry associations involved: BIO, IFPMA, PhRMA GSK position: The Declaration of Helsinki sets out the ethical principles for the conduct of research on human subjects. The Declaration was revised in 2008 by the World Medical Association. We urged the World Medical Association to resist changes that make the document more detailed and prescriptive, because we believe they create confusion and conflict with other, more detailed guidance such as ICH guidance on Good Clinical Practice. Shaping the scope of the International Regime on Access and Benefit Sharing Organisations engaged: Secretariat to the Convention on Biological Diversity (CBD), Ad Hoc Working Group on Access and Benefit Sharing, UK DEFRA, DG Trade (European Commission), national European governments, US government. Industry associations involved: BIO, BPG, EFPIA, ICC, IFPMA, PhRMA GSK position: The Convention on Biological Diversity (CBD) was signed in 1992. It has three main goals, including the fair and equitable sharing of benefits arising from the use of µgenetic resources¶. GSK believes that the best way to achieve the CBD¶s access and benefit-sharing objectives is for countries to introduce national laws governing access to their genetic resources and for mutually agreed contracts to define how any benefits arising from their use should be shared. This approach allows national governments the flexibility to develop guidelines that will best serve their national interests, and enables users of the guidelines to reach agreements that are appropriate to each individual case. Notwithstanding GSK¶s support for national legislation we recognise the CBD¶s mandate to µelaborate and negotiate an international regime on access and benefit-sharing¶. We believe that the resulting regime, currently under discussion within the CBD, should be consistent with the CBD¶s treaty and objectives. It should create no new obligations for CBD signatories and should not be applied retrospectively. It should provide guidance to governments and other CBD members on how to achieve access and benefit-sharing objectives, rather than prescribing rules. It should adopt a sectoral approach and not seek to enforce a µone size fits all¶ solution on all industries. It should apply only to genetic resources as defined in the CBD, not a broader class of materials. It should not extend to human genetic resources, nor to derivatives, or pathogens. Read our position statement on the Convention on Biological Diversity.
European activity Advocacy on the European Animal Directive Organisations engaged: European Commission Industry associations involved: ABPI, EFPIA
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GSK position: The European Animal Directive, originally introduced in 1986, governs the use of animals for experimental or other scientific purposes. It aims to establish a framework for all animal research activities within the EU. The European Commission has published a draft revision of the Directive which controls the use of laboratory animals and sets minimum standards for their housing and care. GSK welcomes the review of the Directive and recognises the need for it to be revised to reflect advances in animal welfare and science. We welcome many of the recommendations in the draft revision, many of which are already integrated into our current practices. For example, we welcome the rules relating to the replacement, reduction and refinement in the use of animals in research (known as the 3Rs), and the need for a permanent or standing ethic review body in the establishments that use animals in research. It is essential that any legislative changes achieve high animal welfare standards while supporting an environment that allows research that leads to new medicines and vaccines to meet patients¶ needs. In this regard we have a number of concerns related to the restrictions on the use of non-human primates to those diseases that are considered life-threatening or seriously debilitating and the reuse of surgically instrumented animals which is likely to result in an increased number of animals where procedures are mild to moderate. Read our position statement on use of non-human primates in research. Supporting a new approach to pharmacovigilance in the EU Organisations engaged: European Commission, European Medicines Agency, UK government Industry associations involved: ABPI, EFPIA GSK position: GSK seeks a new approach to pharmacovigilance regulation in the EU that will allow pharmaceutical companies and regulators to focus their resources on safety evaluation activities instead of compliance with unclear and complex regulatory demands. New pharmacovigilance legislation should contain clear and concise provisions to simplify, strengthen and provide legal certainty to the EU legislative framework for pharmacovigilance. Specifically, it should: Contain a single set of simplified rules, and a single reporting point, for adverse drug reactions in the EU Require the reporting of all serious cases when an electronic reporting system is implemented Contain clear and flexible provisions that allow individual companies to appoint the number Qualified Persons for Pharmacovigilance (QPPVs) they require Provide consistent standards for inspections of company pharmacovigilance departments by EMEA and EU member state authorities
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on patient safety
Corporate Responsibility Report 2008 Advocacy on patient safety US activity Legislation on prescription medicine imports Organisations engaged: US Department of Health and Human Services, Food and Drug Administration (FDA), US Congress, state Boards of Pharmacy, state legislators, Governors¶ Offices Industry associations involved: BIO, PhRMA GSK position: Current US law prevents prescription medicines from being imported to the US unless they have safety and cost savings certifications from the Secretary of Health and Human Services. Pending legislation would remove the safety and savings certification requirements, making it easier to legally import medicines. This would undermine the FDA¶s ability to protect the US distribution system from counterfeit and unsafe medicines that could harm patients. There is also no guarantee that consumers would save any money, as the Department of Health and Human Services has found that third -party payers such as insurance companies are most likely to benefit. GSK supports safer alternatives to help patients afford their medicines. The Partnership for Prescription Assistance (PPA), for example, gives access to more than 475 public and private patient assistance programmes, for patients who lack prescription drug coverage. Read more about GSK¶s Patient Assistance Programs.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on intellectual property
Corporate Responsibility Report 2008 Advocacy on intellectual property US activity US patent system reform ± Federal legislation Organisations engaged: Patent and Trademark Office (PTO), US Congress Industry associations involved: BIO, Coalition for 21st Century Patent Reform, PhRMA GSK position: A patent law framework that provides business certainty over a long period and promotes investment is essential to the research-based pharmaceutical industry and a wide range of other manufacturers that have long lead times from research to market. The US Congress is considering patent reform legislation that could have a negative effect on the current framework. Specifically, the proposals fail to strike an appropriate balance in the areas of restricting abuse of the inequitable conduct doctrine (which encourages infringers to try to prove in litigation that a patent was improperly obtained so that a completely valid patent may be held µunenforceable¶) and the allocation of damages for infringement. In addition, giving the PTO substantive rule-making authority removes responsibility for establishing substantive patent law from Congress and innovation policy from the public debate. GSK is working with a coalition of research-based companies, manufacturers, universities and small inventors to promote US patent reform that stimulates investment in research and strengthens the patent system. We support patent reforms that are clear, provide business certainty, improve the quality of patents and remove subjectivity in litigation issues.
Asian activity Compulsory licensing in Thailand Organisations engaged: Thai government including the Thai Ministry of Public Health; academics, NGOs and members of the business community in Thailand; World Health Organization; international NGOs; US and EU member state Industry associations involved: BPG, EFPIA, IFPMA, PhRMA, PReMA GSK position: In late 2006 the Thai government issued compulsory licences on three pharmaceutical products. Four more compulsory licenses for oncology products were announced just prior to the previously elected government leaving office in early 2008 of which two were implemented. We support the Thai government¶s public health goals and want to help improve health outcomes for people in Thailand. Compulsory licences are a legitimate policy option for the Thai government but they should not be used as a routine policy tool or for commercial purposes. Rather than unilaterally using compulsory licences to increase access to medicines, we believe it is more effective to engage in dialogue with industry and other stakeholders to find sustainable ways to address healthcare issues, including access to medicines. We hope to reinforce this dialogue with governments and other stakeholders in the future. Healthcare and intellectual property in India Organisations engaged: Relevant agencies in the Indian government; members of the pharmaceutical industry and the wider business community in India; Indian academics and civil society representatives; US and EU member state governments; European Commission Industry associations involved: BPG, EFPIA, OPPI, PhRMA
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
GSK position: We believe that India¶s tremendous strengths in science and pharmaceuticals, coupled with its rapid economic growth, offer the government an opportunity to tackle some fundamental characteristics of its healthcare system and policy base. Further improvements in India¶s intellectual property (IP) regime to the level provided in the EU and US could further encourage investment in collaborative R&D. Issues of IP rights are not the fundamental barrier to access to healthcare and we believe that reform and increased investment in the Indian healthcare system should be a priority. We want to be active partners in addressing these challenges.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on pricing and competitiveness
Corporate Responsibility Report 2008 Advocacy on pricing and competitiveness European activity Guiding principles for relative effectiveness assessments and pricing Organisations engaged: EU member states, the European Commission, stakeholder representatives participating in the EU¶s High Level Pharmaceutical Forum Industry associations involved: EFPIA, EuropaBio GSK position: Government funding decisions are often based on an assessment of a medicine¶s clinical or cost effectiveness. We believe that these value assessments should be conducted transparently and in a timely manner and all key stakeholders should be able to submit evidence for the assessments. Governments should allow greater pricing flexibility when the long-term value of a medicine is not certain at launch. GSK, representing EFPIA, strongly supported the Good practice principles for relative effectiveness assessments which were developed within the framework of the EU¶s High Level Pharmaceutical Forum (HLPF). These were adopted in 2008 along with the Guiding principles for good practices implementing a pricing and reimbursement policy. EFPIA¶s Health Technology Assessments principles, which the industry has previous adopted and that GSK helped to develop, are aligned with the principles adopted by the HLPF. Improving regulations that impact on the pharmaceutical industry¶s competitiveness in the UK Organisations engaged: UK government and the European Commission Industry associations involved: ABPI, CBI, Institute of Directors GSK position: The pharmaceutical industry is one of the most highly regulated industries in Europe. GSK supports strong regulation but has been working with the UK government and the European Commission to propose ways to simplify regulations while achieving the same policy goal. This aligns with the aims of the UK government and European Commission to reduce the regulatory burden placed on industry. GSK submitted a series of 50 proposals to the UK government for simplification of existing regulations. We also made a similar submission to the Commission, focusing on regulations that originate at a European level.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Political contributions and lobbying expenditures
Corporate Responsibility Report 2008 Political contributions and lobbying expenditures In late December 2008, GSK announced a new global policy to voluntarily stop all corporate political contributions. Prior to this, GSK made political contributions with corporate funds in countries where they were authorised by law and were culturally appropriate, such as the US and Canada. The new policy ensures that no such contributions will be made in the future. Contributions to political parties or other political organisations in the European Union were prohibited by GSK policy prior to this change. See the corporate governance section of our Annual Report for more information. Prior to this policy change, in 2008 we contributed 347,000 to political organisations in the US and Canada. In the rest of the world, contributions have been very rare and of low monetary value. These contributions were agreed by local management and approved by GSK¶s international legal operations and corporate government affairs department. All contributions were made in compliance with local laws and customs.
Contributions in the US In the US, corporate contributions to party affiliated committees and candidates running for federal office are prohibited by law. State and local political campaigns are financed through a variety of sources including contributions from companies, individuals, NGOs and local campaign committees. By supporting pro business candidates, corporate contributions are an accepted and legal means for corporations to have a voice in the political debate. However, to ensure that there is no implication whatsoever that such contributions provide GSK with any special privileges, the company changed its policy in late December 2008 to prohibit any corporate contributions to political candidates. Contributions to state candidates In 2008 prior to the change in policy, GSK donated 319,000 to candidates for state-held offices. Contributions were only made where permitted by law and were not made on the basis of political party. Contributions were made to candidates who support an environment that appropriately rewards high-risk, high-investment industries and who work to preserve free market principles and intellectual property rights. We made approximately 46 per cent of our contributions to Republican candidates and 54 per cent to Democratic candidates. All states publish information disclosing the names of contributors and the amount of contributions that are at or above an established threshold. Political Action Committee contributions In accordance with the Federal Election Campaign Act, GSK established a Political Action Committee (PAC) that facilitates voluntary political contributions by eligible employees. The PAC is not controlled by GSK. Decisions on the amount and recipients of contributions are made by participating employees exercising their legal right to pool their resources and make political contributions. All PAC contributions are voluntary and contributions are subject to strict limitations. For example, the GSK PAC may not contribute more than $5,000 per election to an individual candidate for federal office. The PAC is run by a governing board of participating GSK employees from across the company. As required by law, PAC contributions are reported to the Federal Elections Commission (FEC). In 2008, the GSK employees¶ PAC contributed 539,359 - 58 per cent to Republicans, 40 per cent to Democrats and two per cent to unaffiliated or other party candidates running for state and federal offices.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Contributions in Canada In 2008, GSK donated 28,000 in Canada to political candidates in those provinces where it is legal.
Lobbying expenditure Europe In December 2008, GSK signed up to the European Commission¶s new code of conduct and the voluntary register of organisations working to influence European Union institutions. In the µtransparency register of interest¶, we declared the costs associated with lobbying of the EU institutions to be in the range of ¼750,000800,000 in 2008. This includes running of the Brussels advocacy office, salaries, external events and educational materials. This figure takes into account the proportion of employee time spent on interest representation. US We report our US lobbying expenditures to the US Congress in accordance with the Lobbying Disclosure Act 1995. We spent $6.99 million in federal lobbying activities in the US during 2008. This includes the costs of salaries and benefits for all employees registered to lobby the US government; use of lobbying consultants; support for lobbying contacts such as planning activities and research; running the GSK Washington DC government affairs office; support staff; and the portion of trade association fees associated with federal lobbying. We also report our state lobbying expenses, in line with applicable state laws. Contributions to policy groups GSK contributes to various groups which provide a forum for policy analysis and debate. This includes think tanks in a number of countries, and '527' organisations in the US.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Patient advocacy
Corporate Responsibility Report 2008 Patient advocacy Patient groups are non-profit organisations founded by patients, care-givers, family members and health professionals. They provide their members with information about their condition and guidance on how to live with their disease. They engage with healthcare providers, governments and the media to promote improved treatment and services for patients and campaign for change on issues that affect patients¶ and carers¶ lives. Some carry out vital research into the causes and potential treatments for specific conditions. GSK works with a wide range of patient groups in disease areas such as cancer, asthma, diabetes, Alzheimer¶s disease, multiple sclerosis and HIV/AIDS. GSK and patient groups share a common concern that healthcare systems should focus on preventing, treating and managing disease. Both parties believe that patients should have access to quality medicines, services and information on disease. Patient groups are important stakeholders for GSK and we engage with them as part of our commitment to be a patient focused company. Our relationships with patient groups are mutually beneficial. They help us to better understand patient needs and their illnesses. We work with patient groups to strengthen their support for patients throughout their illness, from diagnosis to chronic treatment and end -of-life care. We also help these groups give patients the ability to have their voice heard in the healthcare debate, alongside other stakeholders.
Our approach We support patient groups across the world in a number of different ways. These include: Providing core funding to support the day-to-day running of the group One-off donations to help patient groups conduct a specific event or activity, for example a breast cancer awareness day Educational support Training staff in management skills and disease education Working together on disease awareness/prevention projects Our relationship with each patient group is defined by a written agreement specifying how the group will use our funding to benefit its members. Some stakeholders are concerned that pharmaceutical companies use patient groups as a way of marketing their products. Our support for patient groups is about the bigger agendas that dictate whether or not new medicines are made available to patients, and whether patients have access to the kind of treatments that they need. We are committed to maintaining the highest ethical standards and transparency in this area. We have developed detailed guidance and Standard Operating Procedures (SOP) for employees in each of our major regions. These policies, used in conjunction with GSK¶s patient advocacy manual, ensure that GSK employees who work with patient groups comply with applicable laws and regulations and our standards. Read a summary of our SOP. All employees, and outside agencies working for GSK that are likely to interact with patient groups, must abide by our guidelines and SOPs. We provide training so that our employees understand our requirements. For example in 2008, around 70 marketing employees in the US attended a webinar on our guidelines and SOPs.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Our patient advocacy teams in Europe and our Asia Pacific, Japan and Emerging Market region coordinate interaction with patient groups and adherence with our policies and global principles. In the US, patient advocacy is decentralised across a number of functions including state government affairs, R&D, communications and marketing, but is coordinated by the state government affairs group. Employees in all regions can access our patient advocacy resource intranet site. In Europe, we also publish a newsletter to raise employee awareness about internal and external developments relating to patient groups. In 2007, we conducted a review of departments that have relationships with patient groups in the US. This led to the development of an interactive patient group database that tracks our relationships with patient advocacy groups and the projects we support. This will enable employees to learn about past interactions with patient groups and the type of projects supported. It will help us to allocate resources to patient groups more efficiently. The database will be launched in 2009.
Encouraging independence We believe that patient groups should be independent and we encourage them to seek financial support from as wide a range of organisations as possible. We ensure that the funding we give to patient groups is appropriate to their size. Our guidelines state that GSK funding should make up no more than 25 per cent of a group¶s overall income. In the vast majority of instances the actual percentage is much lower. We allow some exemptions to the 25 per cent cap as some of the groups supported have limited incomes, so a small donation (for example 1,000) would exceed the limit, and because some groups have difficulty attracting funding because of the nature of their activity (for example, providing needle exchange for drug users). These cases must be approved by the general manager of each local operating company. We also encourage patient groups to seek funding from multiple sources and we hold workshops on how to make funding applications.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Patient advocacy Transparency
Corporate Responsibility Report 2008 Transparency We believe that being transparent about our support for patient groups helps build trust with our stakeholders, including the groups themselves. We publish information on all our work with patient groups in our Europe and Asia Pacific, Japan and Emerging Markets regions, as well as information on our support for patient groups working globally, including details of the funding received. See details of our funding for patient organisations. We were the first pharmaceutical company to publish this level of information and it goes beyond industry codes of practice that at most require a list of the groups funded. Detailed information for GSK Australia and Canada can be found on their websites. In the US, from February 2009 we will report educational and charitable grants provided to health -related organisations, including hospitals, teaching institutions and patient advocacy groups. The report will be updated quarterly. See details of our funding for patient organisations Working with patient groups
Our Standard Operating Procedures state that: Any involvement with a patient organisation must be declared and transparent GSK must neither seek patient organisation endorsement for its medicines, nor pay patient groups to endorse GSK services Medicines must not be promoted to patient organisations GSK must not create patient organisations, must not be the sole funding sponsor of a patient organisation, and should not provide more than 25 per cent funding to patient organisations. Exceptions may be allowed in the case of rare disease focus or start-up funding up to 50 per cent. However, must be agreed with directly with the local country or region general manager or head of regional government affairs GSK must not seek a direct return on investment from the funding of a patient organisation Any information on GSK pipeline compounds must be factual and non-promotional and provided to patient organisations as part of a scientific dialogue It is acceptable for GSK clinical trials or medical personnel to work with patient organisations to ensure optimal clinical trial recruitment, and to consult them on clinical trial design and protocols GSK must not directly sponsor patient organisation representatives to attend medical congresses, conferences and other healthcare professional events. Exceptions include where the representative is invited to speak at the conference or where the medical congress has a specific workstream designed for patients. GSK may sponsor representatives to attend non-medical congresses GSK may pay a modest honorarium or speaker fee to the patient organisation that an advisory board member or speaker represents Any third party working for GSK on a given project must be fully transparent about this relationship when interacting with a patient group on the project Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Patient advocacy Understanding patients
Corporate Responsibility Report 2008 Understanding patients To help us better understand patient needs we have set up advisory boards in the US and Europe that include representatives from a wide range of patient groups. The advisory boards have independent chairs, meet regularly and are attended by senior GSK managers. The boards enable the voice of patients to be heard at the highest levels of GSK. They also allow us to access the views of patient groups and we seek feedback on subjects such as clinical trials, pharmacogenetics, information provided to patients and ethical issues. In all regions we invite speakers from patient groups to meet GSK employees, including scientists, researchers and marketers, to discuss issues affecting their members. As well as improving our understanding of patient needs, it shows GSK employees the difference their work can make to people¶s lives. Read about how our Focus on the Patient initiative is helping us to better understand patient needs and develop better medicines. We also engage with patient groups through Patient Advocacy Leaders¶ Summits (PALS). These bring groups together to discuss health policy concerns, develop new skills and/or ways to expand their influence. PALS can also give patient groups the opportunity to learn about GSK and tell the company how it can better support their work. In 2008 we were involved in running a total of 33 summits: 14 in nine European countries, one in Japan and 18 throughout the US. Discussions at the 2008 PALS focused on a broad range of issues, including: Efforts to establish patient-centred healthcare (Japan) Availability of medicines and the role of patients and patient organisations (Netherlands) Clinical trials (Germany) Healthcare as a political priority and healthcare funding impacts on patients (Estonia) Healthcare system reform and patient rights (Czech Republic) Healthcare financing and patient access to healthcare in an economic downturn (Latvia) Patient input to the national strategy for cancer (Bulgaria) Communications strategies for patient associations (France) Importance of innovation, intervention and prevention in health care reform (US) In 2008, GSK co-sponsored the European Patient Forum¶s annual conference in Brussels with the pharmaceutical company Pfizer. This brought together approximately 100 patient groups and other stakeholders to exchange ideas about improving healthcare and the role of patient organisations. We intend to hold a further 20 PALS summits in the US in 2009 and in Europe we will support a similar number of PALS as in 2008. We also plan to have several regional PALS meetings in our Asia Pacific and Emerging Markets regions.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Patient advocacy Developing industry standards
Corporate Responsibility Report 2008 Developing industry standards We are taking a leadership approach in developing industry standards for engaging with patient groups. In the US, we are working with the industry trade group PhRMA to develop guidelines for its members on working with patient groups which will be launched in May 2009. We also helped the National Health Council to develop guidelines for patient groups to follow when working with companies. Patient group members of the Council are required to follow the guidelines, which were launched in 2008. Update August 2009
Since the publication of this report, our work with PhRMA to develop guidelines on working with patient groups has stopped. All companies did not agree on the need to develop industry wide guidelines, however PhRMA supports the National Health Council guidelines for patient groups when working with companies. GSK remains committed to developing industry standards for engaging with patient groups. In Europe, we were closely involved in the development of the first EFPIA code of practice on relationships with patient organisations, which came into effect in July 2008. The code bears a close resemblance to GSK¶s policies on working with patient groups, and a senior GSK manager chaired the EFPIA Patient Relations Network that originally developed the code. The EFPIA code contains many of the requirements of GSK¶s policies. It states that companies cannot promote their medicines to patient groups, there must be written agreements in place for all interactions with patient groups, and companies must list all patient groups they work with and describe the nature of any support. We have been involved in training other companies to prepare to implement the code at the European level and locally in countries including Finland and Germany. Back to top
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Patient advocacy Advocacy in 2008
Corporate Responsibility Report 2008 Advocacy activity in 2008 Here we describe some of the advocacy activities we undertook in 2008 in partnership with patient groups. Global recruitment for lung cancer vaccine clinical trial We partner with the Global Lung Cancer Coalition (GLCC), a body comprising 23 not-for-profit groups from around the world, that promotes understanding about lung cancer and advocates for patients¶ right to early detection, better treatment and supportive care. GLCC members are also committed to campaigning for more lung cancer research and an increase in enrolment of patients into clinical trials. As with many other new therapy trials, the GLCC network helped us in the recruitment of patients for the phase lll clinical trial of our therapeutic lung cancer vaccine. We raised awareness about the trial through GLCC members who disseminated information to lung cancer patients, calling for those who had recently undergone surgery to ask their doctors about entering the study. We hope that the vaccine, to be given to lung cancer patients after surgery, could help stop tumours returning and reduce the effect of the disease. Chronic hepatitis B in Asia Pacific In 2008 we continued our campaign in Asia Pacific to raise awareness about chronic hepatitis B, increase the number of people being tested and diagnosed, and improve compliance with antiviral medication. Around 300 million people in the region live with the disease. GSK and a patient consortium developed a patient engagement programme and created resources to support healthcare professionals and encourage patients to adhere to their treatment regimes, including an SMS service that reminds patients about how to manage their condition. We piloted the programme and resources in Korea in 2008, and will roll them out across ten more countries by World Hepatitis Day in May 2009. Raising awareness about breast cancer treatment times in Canada Through our partnership with the Canadian Breast Cancer Network (CBCN), GSK helped raise awareness about unacceptable treatment waiting times and differences in access to breast cancer care across Canada¶s provinces. In 2008, the CBCN published a report that revealed waiting times of up to five years from the initial application by the manufacturer until patients could access a new breast cancer drug. The report provoked extensive national media coverage and a strong call to action for policy makers, politicians, concerned organisations and individuals to work together to address these issues.
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Public policy and patient advocacy Q&As
Corporate Responsibility Report 2008 Q&As How do you make sure that your lobbying activity doesn¶t contradict or undermine your corporate responsibility work? Corporate responsibility is central to our business. We aim to ensure that all our lobbying activity reflects the values set out in this report as well as being sensitive to the views of our stakeholders. Employees involved in public policy must abide by our Employee Guide to Business Conduct which commits them to acting with honesty and integrity. We have well-established public policy positions. These are developed through wide consultation and are approved by our Corporate Executive Team. Employees who lobby for GSK are closely involved in developing these positions. We believe transparency is key to building trust with our stakeholders and we disclose our public policy positions on our website. Does GSK make political contributions through so-called µ527¶ organisations? Yes, we support a number of µ527¶ organisations such as the New Democratic Network. GSK has no influence over how µ527¶ organisations use GSK contributions; however, our support enables the organisations to develop and advocate policy positions and us to participate in their functions and to debate and discuss important issues for GSK with other organisations, the public and policy makers. Contributions to µ527¶ organisations are not defined as political contributions and so are not subject to our policy to stop all corporate political contributions. Isn¶t your support for patient groups just another marketing tool? No. GSK neither promotes medicines to patient groups nor would ever ask a patient group to endorse a GSK medicine. We work with patient groups in a number of areas, including improving how clinical trials are run, disease awareness initiatives, and on the bigger agenda of ensuring that all new medicines are made available to patients. When GSK provides funding, are you trying to µbuy¶ favours from the patient organisation? No. We never ask for endorsement of any of our medicines or a return on investment for our support. We are careful that our support for an organisation does not compromise its independence and is based on trust and mutual respect, and complies with the highest standards of our code of conduct. How do these groups maintain their independence if they receive significant funding from companies such as GSK? We encourage patient groups to diversify their funding from sources in both the public and the private sector. Patient groups should never become dependent on any one funder from either sector. Our guidelines state that we should provide no more than 25 per cent of a group¶s overall income, except in exceptional
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Appendix A: GSK Corporate Responsibility Report, 2008 (cont.)
Home Responsibility Our work with communities
Corporate Responsibility Report 2008 Our work with communities We donate money, time, medicines and equipment to support communities around the world. Our programmes are long term and focus on addressing healthcare challenges and increasing access to medicines. We also invest in improving education, especially science education, and provide some support for art and environment initiatives. We believe contributing some of our profits to benefit communities is part of being a responsible company. Community investment also brings us long-term business benefits by improving our reputation, boosting employee morale and helping us build good relations with governments. We do not use community investment as a way of generating sales. We invest in innovative projects to: prevent disease build the capacity of community organisations promote education, particularly in science We focus our community investment on areas relevant to our business and the skills of our people. This is where we can bring the most benefit to communities and GSK. Most of our investment is made through non-profit organisations that are experts in healthcare and education. These organisations are best placed to understand local community needs and to target resources effectively. Donations are made at a company level and by individual sites.
Healthcare We support major public health initiatives in the developing world. For example: We are a founding member of the Global Alliance to Eliminate Lymphatic Filariasis (GAELF). We have committed to donating as many albendazole tablets as are needed to eliminate lymphatic filariasis (elephantiasis), a disabling parasitic disease that threatens 1.3 billion people ± one-fifth of the world¶s population - in over 80 countries Our Positive Action programme works with communities to reduce stigma and improve capacity for HIV prevention and treatment Our African Malaria Partnership supports Mobilising for Malaria, an advocacy initiative to generate political commitment and funding to combat malaria PHASE ± Personal Hygiene And Sanitation Education ± is our hand-washing programme for children to prevent diarrhoea-related disease and improve school attendance We donate essential antibiotics and other medicines for disaster relief to under-served communities around the world, while specific programmes support low-income, uninsured patients in the US
Education We support education programmes [link to Supporting science education] in the UK and the US to inspire young people about science, improve their understanding of science and encourage them to pursue a science-related career. Our programmes enable young people to make informed decisions about the
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science-related issues they meet in everyday life such as healthy eating, vaccinations and the value of medicines.
Measuring impact We ask our partner organisations for our larger programmes to report annually on the progress of the projects supported by GSK to ensure that the money we give has the greatest possible impact. We review results with our partners and identify any changes required to achieve the programmes¶ objectives.
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Home Responsibility Our work with communities Community investment
Corporate Responsibility Report 2008 Community investment In 2008, our global community investment was 124 million ($229 million) compared with (restated) 109 ($219 million) in 2007, an increase of 13 per cent. Just over half of this comprises product donations and this is the first year we have valued donations using cost (average cost of goods) rather than the wholesale acquisition price (WAC). Our new approach to valuing donations is a more accurate reflection of the true cost to GSK and is therefore more transparent. We believe we are the first pharmaceutical company to adopt this practice. We will continue to also report the WAC value of our donations for benchmarking purposes. We belong to the UK¶s London Benchmarking Group (LBG) and the US Committee Encouraging Corporate Philanthropy (CECP). LBG guidelines report product donations at cost, whereas CECP guidelines report product donations at market value. For comparative purposes the total value of giving in 2008 using WAC for products would be 343 million ($634 million) compared with 282 million ($564 million) in 2007. The giving figure is built up in the following way: Method of giving ( million)
Breakdown of cash giving (%)
Our product donations are made through three main programmes:
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Our Patient Assistance Programmes to support low-income patients in the US, totalling 56 million (at cost) in Humanitarian product donations to under-served communities in 118 countries, including people affected by the natural disasters in Burma and China, totalling 5m (at cost) in 2008 Donation of 266 million albendazole tablets for the lymphatic filariasis (LF) elimination programme. In 2008 we announced we would double our manufacturing capacity for albendazole tablets to 600 million tablets per year by 2010 from the current 300 million, to meet the growth of the LF programme, especially in India. As a result, our donations of albendazole tablets will increase significantly from 2009 onwards We already publish data about our charitable grants made to patient groups in our European, Emerging Markets and Asia Pacific regions. We are further increasing transparency by publishing details of all our charitable grants over 10,000 ($20,000). Find out more about our grants. GSK was one of 21 companies and the only manufacturing company to be awarded the new CommunityMark, following independent assessment, for outstanding community investment. The Mark, created by Business in the Community, is endorsed by the UK government and voluntary sector leaders. It was given for our work at local and national level in the UK as well as for our larger international programmes.
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Home Responsibility Our work with communities Preventing disease
Corporate Responsibility Report 2008 Preventing disease Infectious diseases kill millions of people in the developing world each year. They cause misery, cost billions of dollars and slow economic growth. Preventing infection is more effective than treatment and can have significant social and economic benefits. Our vaccines play a significant role in preventing disease. GSK supports innovative community approaches to disease prevention that are tailored to local settings and needs. 2008 marked two significant milestones in our support for community disease prevention; it is ten years since we made a commitment to eliminate lymphatic filariasis (LF) worldwide and since we launched our hand-washing programme PHASE, to prevent diarrhoea-related disease. We also support a wide range of local programmes to help prevent disease in the communities where we operate.
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Home Responsibility Our work with communities Preventing disease Eliminating lymphatic filariasis
Corporate Responsibility Report 2008 Eliminating lymphatic filariasis (LF) We have committed to donating as many tablets of albendazole, our anti-parasitic drug, as are needed to eliminate LF. LF is a disfiguring disease prevalent in tropical and sub-tropical countries. Transmitted by mosquitoes, it can lead to severe swelling of the arms, legs, breasts and genitals and thickening of the skin. LF is one of the world¶s leading causes of permanent disability, with 1.3 billion people in over 80 countries (approximately one-fifth of the world¶s population) at risk of infection. In 2008, GSK donated 266 million albendazole treatments to 30 countries. This included 130 million tablets to India, the country with the largest LF burden. The economic cost of LF in India is estimated to exceed US$840 million due to treatment costs and reduced working time. Since the programme began we have donated over one billion tablets and over 180 million people have been treated at least once with albendazole. We estimate that to the end of 2007 66 million babies born in the treated regions have been spared the risk of contracting LF. A study published in the journal Public Library of Science on Neglected Tropical Diseases confirmed the progress already made towards eliminating LF. This year we decided to double our annual manufacturing capacity for albendazole tablets to 600 million tablets per year by 2010 by opening of a new production line in Nashik, western India. An additional benefit of the albendazole tablets given for the LF programme is that they also treat intestinal worms. These parasites particularly affect children, causing anaemia and malnutrition, and stunting growth. We estimate that since the beginning of the LF programme, over 170 million albendazole treatments have been administered to children and over 140 million to women of child-bearing age. This will have had a positive impact on the overall health of those infected with intestinal worms. Each country aiming to eliminate LF must treat all at-risk people once a year for at least five years. So far, Egypt, several Pacific Island countries, Sri Lanka and Zanzibar have completed five annual mass drug administrations (MDAs). These countries are monitoring their populations to evaluate the impact of the programme on the disease. Assessments conducted in Egypt and Vanuatu, a Pacific Island nation, showed that LF has been eliminated in most areas of these countries. Programmes in Tanzania, Madagascar and Burkina Faso have also reported an unexpected benefit of the MDAs, beyond reducing infection rates. In these countries, some patients already infected with LF are describing an alleviation of symptoms after the MDAs, including reduced leg swelling and a reduction in frequency and length of acute attacks (spells of feverishness and loss of energy). Acute attacks are the most incapacitating symptom of LF. Read more about our approach to LF and the patients who are living with the disease.
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Home Responsibility Our work with communities Preventing disease Personal Hygiene and Sanitation Education
Corporate Responsibility Report 2008 Personal Hygiene And Sanitation Education (PHASE) Every year more than two million people die of diarrhoea-related disease, mostly children in developing countries. These deaths can often be easily prevented through better hand-washing and sanitation. PHASE is a school-based programme that helps to reduce diarrhoea-related disease by encouraging school children to wash their hands. We established PHASE in 1998 and since then we have invested over 4 million ($7 million) in the programme. PHASE is run in partnership with AMREF, Save the Children and Earth Institute at Columbia University, as well as Ministries of Health and Education in the countries where the programme operates. The programme has had impressive results. In Bangladesh, for example, in partnership with Save the Children, we introduced PHASE to 127 schools in one of the country¶s poorest areas, where it is helping to improve the lives of 20,000 young children and their families. In the three-year period of the programme¶s funding: Schools with hand-washing facilities increased from 5 per cent to 97 per cent, leading to an increase in hand washing with soap by schoolchildren from 40 per cent to 75 per cent More latrines were made available in schools and a further 1,200 latrines constructed in children¶s homes, resulting in a marked decrease in open defecation from 75 per cent of the population to 13 per cent With healthier children, school attendance rates increased from 53 per cent to 80 per cent over the period 2006 to July 2008 The success of PHASE in Nasirnagar (Bangladesh) led to the decision to expand the programme to include all 950 schools in the Brahmanbaria district. Save the Children is now working with health and education ministers to prepare them for the scale-up. In 2008, we committed funding of 320,000 over three years to extend the programme into the slum areas of Mumbai in India with our partner Pratham. PHASE now operates in 13 countries and has reached over 500,000 children. Our aim is for the programme to reach over one million children by next year.
Supporting the Millennium Development Goals In 2000 world leaders agreed the Millennium Development Goals (MDGs) to meet the needs of the world¶s poorest people. The MDGs include targets to halve extreme poverty and hunger by 2015, and improve education, health, gender equality and environmental sustainability. We have introduced PHASE to two Millennium Villages in Malawi and Senegal. Millennium Villages are research projects in African communities designed to find practical ways to meet the MDGs
Global Hand-Washing Day The first Global Hand-Washing Day was held during 2008. This was marked by a week of activities encouraging millions of children and adults around the world to wash their hands, with the aim of improving hygiene and health. PHASE partners arranged a range of activities to promote hand-washing which reached around 300,000 people. Read more about PHASE and the Global Hand-Washing Day.
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Home Responsibility Our work with communities Preventing disease Local programmes
Corporate Responsibility Report 2008 Local programmes We support a wide range of programmes to help prevent disease in the communities where we operate. We fund these programmes at corporate and local levels. Below are just a few local programme examples. Australia - helping Aborigines tackle diabetes Indigenous Australians have poorer heath and a life expectancy of about 20 years less than the rest of the Australian population. This is due to the rapid increase in so-called µlifestyle¶ diseases, including type 2 diabetes, and could wipe out indigenous populations in 20 years. GSK is working with the Unity of First People of Australia in the far north of Western Australia on their Diabetes Management and Care Program. The programme aims to arrest the rising incidence of diabetes in Aboriginal communities by encouraging the local people to take on the responsibility for their community ¶s health, because health providers can only do so much without their active support. UK ± improving sexual health services for disabled people We have donated over 520,000 over three years to Leonard Cheshire Disability to fund a project to give young disabled people better access to sexual health services. The project addresses knowledge and understanding gaps relating to disabled people¶s sexual health issues. Over the three-year period, the organisation will run focus groups and workshops to identify key issues and will develop a range of materials to support sexual health workers who deal with disabled people. UK - promoting sport for children Through our Consumer Healthcare business we support Access Sport, an organisation that encourages young people in the UK to keep fit and participate in sport. In 2008, Access Sport held three µSports Jam¶ events, in Bristol, Bath and London, where more than 3,500 children took part in sporting activities. We provided funding and our employees volunteered their time and held fundraising events. For example, 90 employees raised money by cycling from Land¶s End to John O¶Groats. In future GSK staff will also support Access Sport by volunteering at their local sports clubs during our annual employee volunteering day. Preventing childhood obesity in the US In the US we support the Zone Health initiative which helps schools strengthen their policies and programmes on nutrition and physical activity. It aims to improve the health of more than 200,000 children by 2010. Following a successful pilot, Zone Health is being expanded and GSK has announced support for the FitU programme in the Washington DC area, which will benefit more than 600 young people over three years.
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Home Responsibility Our work with communities Building community capacity
Corporate Responsibility Report 2008 Building community capacity Lack of healthcare infrastructure ± including clinics and trained healthcare professionals ± and cultural attitudes are significant barriers to treatment in many developing countries. Our global programmes such as Positive Action is working with communities affected by HIV and AIDS, and our African Malaria Partnership is improving prevention and access to malaria treatment. We support local initiatives that help overcome stigma, build the capacity of communities to provide healthcare and combat disease. We also provide humanitarian relief in times of emergency and natural disasters.
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Home Responsibility Our work with communities Building community capacity Combating HIV/AIDS ± Positive Action
Corporate Responsibility Report 2008 Combating HIV/AIDS - Positive Action Positive Action works with community organisations to build capacity to counter the ignorance and stigma surrounding HIV through outreach, education and advocacy. Since it was established in 1992, it has provided over $70 million, funding projects in 63 countries across Africa, Asia, Latin America and Eastern Europe. Through Positive Action, GSK has pioneered support for vulnerable communities, including men who have sex with men, intravenous drug users, sex workers, migrants, young people, orphans and vulnerable children and marginilised poor rural women - groups who have limited human rights or public voice and are thus excluded from playing a role in developing mainstream programming. It is essential to work with these groups if we expect to make a difference to this epidemic. During 2008, we supported 18 Positive Action programmes in 21 countries. Key projects include: Fighting stigma and discrimination in Mexico among vulnerable sectors of the population Bringing HIV education to vulnerable women in India through self-help groups Helping communities in Asia understand and prepare for treatment programmes Improving access to treatment in Kenya by promoting greater understanding and involvement of communities Update August 2009
In July 2009 we announced the creation of a new Positive Action for Children Fund. The Fund will make 50 million ($80 million) available over ten years to help prevent mother-to-child transmission of HIV and to support orphans and vulnerable children. Positive Action programmes involve grass roots organisations that are able to continue to support their communities after the projects have come to an end. This year we were the principal sponsor of the Global Village (the community space) at the International AIDS2008 conference held in Mexico City. We also hosted community forums to allow delegates to share experience of their fight against HIV/AIDS. Read more about Positive Action.
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Home Responsibility Our work with communities Building community capacity Combating malaria ± Africa Malaria Partnership
Corporate Responsibility Report 2008 Combating malaria ± Africa Malaria Partnership Every year up to 500 million people are affected by malaria and over one million die from it, mostly young children in Africa. But the disease can be prevented by controlling the breeding of mosquitoes and using lowcost measures such as insecticide-treated nets. Malaria can be cured if treated promptly with effective medicines. We established the African Malaria Partnership in 2001 to improve the prevention and access to treatment of malaria in sub-Saharan Africa. Since then we have invested over $3 million in initiatives to combat the disease. 2008 was the final year of our three-year grant to support Mobilising for Malaria, an advocacy initiative to generate greater awareness, political commitment and sustained funding for malaria in Europe and Africa. National Coalitions Against Malaria have now been launched in the UK, Belgium, France, Ethiopia and Cameroon bringing together advocates and activists from the public sector, NGOs, the media, the private sector and the political, academic and scientific communities. Part of this initiative was the award of innovation grants to civil society organisations in Africa to boost advocacy efforts and inspire African civil society organisations and media to become leaders in the fight against malaria in their own countries. Grants were awarded to civil organisations in Nigeria, Tanzania, Ghana, Mozambique, Democratic Republic of Congo and Burkina Faso. We supported a journalist competition run by the Guardian, a British newspaper, to raise awareness of issues faced by people with malaria and LF. Their global web site attracted 20,000 unique visitors and the winning stories were published in two dedicated supplements. Read more about our malaria programmes.
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Home Responsibility Our work with communities Building community capacity Local programmes
Corporate Responsibility Report 2008 Local programmes We support a wide range of programmes to build healthcare capacity in the communities where we operate. We fund these programmes at corporate and local levels. Below are just a few local programme examples.
Training midwives in Vietnam We support a project to train birth attendants to bring maternal healthcare services to rural villages in Vietnam. The project aims to reduce childbirth complications and decrease newborn fatality from the unacceptably high level of 6 per cent. The trainees are housed in a residential training centre built by GSK at Tu Du Hospital, Ho Chi Minh City. Supported by hospital staff, they spend four months gaining practical knowledge of maternal and child healthcare. During the first phase of the project, between 2004 and 2007, over 520 midwives ± representing 38 of Vietnam¶s 54 ethnic groups ± have graduated with a government-recognised qualification. The midwives return to their villages equipped with a medical pack. Some are also provided with a motor scooter to assist access to remote areas. Phase two of the project was launched in 2008. This involves hospital staff visiting villages to provide additional training to the midwives and to provide basic pregnancy and reproductive health education for community members.
Palliative care for children in Romania Over the last three years we have been working in partnership with the Hospice Casa Sperentei in Romania on the µBeacon of Hope¶ project to improve the level of care available to terminally ill children in the Balkans. Huge progress has been achieved, helping to change attitudes towards dying patients in the region. The project has received acclaim from the Romanian government, which began a partnership with the hospice in 2007 with a view to creating a national plan for palliative care. Key achievements include the establishment of a children¶s palliative care unit in Brasov, a mobile nursing team and a network of care SURYLGHUVDFURVVWKHUHJLRQ7KH project has developed a regional centre of excellence for the whole of south-eastern Europe that provides palliative care training for health workers and volunteers. As a result, children¶s palliative care services have been set up in neighbouring Moldova.
New fund for Children¶s Hospital of Philadelphia In October 2008 we announced a $1 million donation to the Children¶s Hospital of Philadelphia to help young people with cancer in the US. The hospital runs one of the world¶s largest paediatric cancer programmes. Our contribution, together with a matched donation from the hospital, will form the GlaxoSmithKline Hope for Families Fund. The Fund is a permanent endowment to enable children and young adults suffering from relapsed and hard-to-cure cancers access to innovative therapies. It will help cover the travel and accommodation costs of patients and their families, who often must stay at or near the hospital for extended periods.
Healthcare for the homeless in Pittsburgh GSK supports Pittsburgh Mercy Foundation¶s Operation Safety Net µStreet Medicine¶ outreach programme that enables Pittsburgh¶s homeless to access free healthcare. The programme includes a mobile medical unit, a drop-in clinic and teams of clinicians and care workers who walk the streets offering medical examinations and treatment to homeless people.
Rewarding community healthcare organisation in the UK
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Each year the GSK IMPACT Awards recognise voluntary organisations that have significantly improved the health of their local communities. Ten winning charities receive 25,000 each and the overall winner is awarded an extra 10,000. In 2008 the UK Impact Awards programme introduced an initiative for the managers of the winning organisations to be trained in leadership, networking and fundraising skills. This will help strengthen small charities that are often unable to afford this vital skills training. The GSK IMPACT Awards also run in Philadelphia in the US. Read more about the GSK IMPACT Awards and the winning organisations.
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Home Responsibility Our work with communities Building community capacity Responding to disasters around the world
Corporate Responsibility Report 2008 Responding to disasters around the world GSK provides humanitarian assistance in the form of cash and product donations in times of emergency and natural disasters. In 2008, as part of our ongoing programme, we provided humanitarian relief to many areas, including China, Burma and Zimbabwe. Following the cyclone in Burma we worked with AmeriCares, one of our partners specialising in rapidresponse delivery, to supply GSK-donated medicines. We also made a donation of 50,000 ($93,000) to Save the Children, a charity that has an established presence in Burma. Our contribution supported recovery efforts, including the provision of shelter, child protection, food and nutrition and emergency health services for over 100,000 children and their families. The earthquake which hit Sichuan Province in China in May left over 70,000 dead and 15 million people displaced or homeless. GSK Hong Kong/China gave a cash donation of 10 million Yuan, approximately $1.4 million, to the China Red Cross, and donated supplies of basic medicines. We provided funds to the British Red Cross for a Mass Sanitation Module to provide emergency sanitation facilities and hygiene education for up to 20,000 people during times of crisis. This helps to avoid outbreaks of disease and was deployed in December 2008 in Zimbabwe to help stem the cholera outbreak. We continued our support for communities affected by the 2004 Indian Ocean tsunami, which caused huge damage to coastal areas across South Asia: In Sri Lanka, we are helping to establish mobile clinics that increase access to quality healthcare for isolated communities affected by the tsunami and conflict in the country. In 2008, 47 mobile clinics were set up in 13 different locations, providing the only reliable healthcare services in these areas. The clinics treated nearly 10,500 patients and in total gave healthcare education messages to 12,000 patients and the people accompanying them We are working with Leonard Cheshire Disability to create an inclusive, barrier-free and rights-based society for people with disabilities who were affected by the 2004 tsunami in Galle, Sri Lanka. A new resource centre will be established to support people with disabilities by providing rehabilitation services, mainstream education and livelihood opportunities. We support long-term relief efforts in affected areas of Chennai, India, by providing nursing training to young women from poor villages. As well boosting healthcare services in the area, the training enables the women to support themselves financially by becoming nursing assistants. Between 2007 and 2009 420 women will be trained. In Thailand we are helping to boost the economies of six coastal villages where the local fishing industry was destroyed by the tsunami. With the Raks Thai Foundation we support initiatives that provide business loans and organise youth activities and efforts to improve the local environment. We also gave funding to help NGO Francois Xavier Bagnoud (FXB) to introduce the concept of a µmodel village¶. This is a low-cost, sustainable, community-based programme that has been successful in helping families to achieve selfsufficiency
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Home Responsibility Our work with communities Supporting science education
Corporate Responsibility Report 2008 Supporting science education In the UK and US, the numbers of young people choosing science subjects is falling and many students lack proficiency in either reading or mathematics. As a result, both countries face a significant skills shortage. The success of our business relies on us being able to recruit talented individuals, particularly those with science qualifications. We also want young people to make sound decisions about the science-related issues they meet in everyday life. Our education programmes help make science more relevant to young people in the UK and US, stimulating their interest in science, and supports the training and development of science teachers.
UK Project ENTHUSE Half of secondary school science teachers in the UK have had no subject training within the past five years. Project ENTHUSE was launched in 2008 to improve continuing professional development of science teachers and to provide them with the latest techniques to rekindle interest in science. Teachers, assistants and technicians can apply for an ENTHUSE Award to help them study at the National Science Learning Centre at the University of York. The award will cover course fees, the cost of covering teachers¶ roles while they are on the course, and travel and accommodation for 2,200 teachers each year. The schools will also receive a small amount of money to help implement ideas back in the classroom. We have committed 1 million to this initiative helping to create a 30 million fund with support from the UK government, the Wellcome Trust and eight other industry partners. CREST Star Investigators After-school clubs help broaden the interests and experiences of young people, but these often focus on sports or arts rather than science. CREST Star Investigators, developed by the British Association for the Advancement of Science and funded by GSK, aims to redress this balance and engage 5 to 12 year olds in science-based activities. The UK-wide programme offers activity packs to schools and other organisations such as the Brownies and Cubs for use in after-school clubs. The activities encourage children to solve scientific problems through exciting practical investigations. The pack contains activities at three different difficulty levels, and children are awarded a certificate when they complete each stage. So far almost 3,000 packs have been distributed to nearly 1,500 schools. By 2010, we aim to have 5,000 schools and 55,000 children taking part.
US Institute for a Competitive Workforce (ICW) Building on GSK¶s leadership at state and local levels related to reform and improvement of public schools, GSK led the effort to create the ICW on a national level. The result has been a national movement for business/education partnerships focused on improved academic achievement in our public school system in order to help ensure a qualified workforce for American businesses in the future. Science in the Summer We support Science in the Summer, a free education programme designed to get young people in
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Pittsburgh, Pennsylvania, Greater Philadelphia and North Carolina interested in science. Classes held in local libraries give children the chance to take part in hands-on experiments and take courses ranging from genetics to oceanography. The programme began in 1986, and in 2008 GSK invested $575,000 across 162 sites where over 6,000 children participated in the programme. North Carolina New Schools Project GSK partners with the North Carolina New Schools Project, an initiative that aims to transform teaching and learning so that high school students graduate ready for college and the workplace. GSK is helping to fund the development of science and technology programmes at ten of North Carolina¶s low-performing high schools. The initiative aims to improve the schools¶ test results and graduation rates. GSK also funds a review of state curricula so that the benefits are shared more widely.
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Home Responsibility Our work with communities Our plans
Corporate Responsibility Report 2008 Our plans Volunteering From 2009, we will expand our volunteering programme so that every GSK employee can spend at least one day a year helping in their community. Employees will select local organisations to support and will undertake a variety of work for them, ranging from manual jobs to fund-raising. This will include supporting employees that wish to visit schools to encourage science education. We will also be launching an international assignment programme to enable a select number of employees to use their professional skills to support our non-profit partners for extended periods.
Positive Action We have agreed to extend three of our larger HIV programmes (Zingatia Maisha in Kenya, Vida Digna in Mexico and Reach India) for an additional year to ensure their sustainability. We will be working with the Ubuntu Education Fund in South Africa to expand a programme called µLiving Positively¶. This programme will work with men and older boys in Port Elizabeth township to challenge gender roles that exacerbate HIV infection and exclude men from HIV services. We will be working with AIDS Action Europe to provide networking for HIV/AIDS NGOs across Eastern Europe and Central Asia for improved HIV policy, advocacy and programming and support for those facing the HIV crisis. We will be working with the American Foundation for AIDS Research (amfAR) to expand its initiative to provide prevention, care and support services for men who have sex with men in Asia Pacific. We will also work with AIDS patient groups in the Philippines to increase members understanding of health issues.
PHASE Our partner Pratham will be implementing the PHASE programme in the slum areas of Mumbai, India. We will also extend PHASE to new districts in Uganda and advocate for the incorporation of PHASE into national policy, enabling sustainability and replication of the project nationwide.
LF We are increasing our manufacturing capacity for albendazole tablets to 600 million tablets per year by 2010. This will enable us to increase fourfold the number of tablets we donated in 2007.
US We are continuing to provide leadership and support to the Children¶s Health Fund (CHF) Referral Management Initiative to increase access to specialist healthcare for homeless and uninsured American families. We are also supporting a pilot telemedicine project to help patients access specialist care. CHF¶s new Memphis Regional Children¶s Health Project will serve as the pilot site to link approximately 400 rural patients with specialists at Memphis hospital, using state-of-the-art videoconferencing technology.
Europe, Emerging Markets and Asia Pacific regions Several new programmes are being implemented. For example In Greece we are helping to introduce the concept of home-based nursing services for children living with cancer
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In the Netherlands, we are supporting a national programme to promote healthy behaviours among young people, helping them to make informed decisions about what they eat and to encourage regular physical activity We will also seek new partnerships to improve community healthcare through social venture and enterprise projects Preparing for when the funding stops
Most of our programmes run over a number of years, recognising that it takes time to build change. But from the start we plan for what will happen at the end of our funding. We work hard with community organisations to bring results over the life of a project (usually around three years) and to help organisations win funding from other sources to continue their work. From the start we require our partners to work to a budget to make sure funding is spent effectively and produces the right results. We also ask our partners to demonstrate achievements by producing an annual progress report. These reports show evidence of success and are a crucial part of attracting new donors.
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Appendix B: President Obama Healthcare Speech
Remarks by the President to a Joint Session of Congress on Health Care | ...
http://www.whitehouse.gov/the_press_office/remarks-by-the-president-to...
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THE WHITE HOUSE Office of the Press Secretary _________________________________________________________________________ For Immediate Release September 9, 2009 REMARKS BY THE PRESIDENT TO A JOINT SESSION OF CONGRESS ON HEALTH CARE U.S. Capitol Washington, D.C.
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8:16 P.M. EDT
THE PRESIDENT: Madam Speaker, Vice President Biden, members of Congress, and the American people: When I spoke here last winter, this nation was facing the worst economic crisis since the Great Depression. We were losing an average of 700,000 jobs per month. Credit was frozen. And our financial system was on the verge of collapse. As any American who is still looking for work or a way to pay their bills will tell you, we are by no means out of the woods. A full and vibrant recovery is still many months away. And I will not let up until those Americans who seek jobs can find them -- (applause) -- until those businesses that seek capital and credit can thrive; until all responsible homeowners can stay in their homes. That is our ultimate goal. But thanks to the bold and decisive action we've taken since January, I can stand here with confidence and say that we have pulled this economy back from the brink. (Applause.) I want to thank the members of this body for your efforts and your support in these last several months, and especially those who've taken the difficult votes that have put us on a path to recovery. I also want to thank the American people for their patience and resolve during this trying time for our nation. But we did not come here just to clean up crises. We came here to build a future. (Applause.) So tonight, I return to speak to all of you about an issue that is central to that future -- and that is the issue of health care. I am not the first President to take up this cause, but I am determined to be the last. (Applause.) It has now been nearly a century since Theodore Roosevelt first called for health care reform. And ever since, nearly every President and Congress, whether Democrat or Republican, has attempted to meet this challenge in some way. A bill for comprehensive health reform was first introduced by John Dingell Sr. in 1943. Sixty-five years later, his son continues to introduce that same bill at the beginning of each session. (Applause.) Our collective failure to meet this challenge -- year after year, decade after decade -- has led us to the breaking point. Everyone understands the extraordinary hardships that are placed on the uninsured, who live every day just one accident or illness away from bankruptcy. These are not primarily people on welfare. These are middle-class Americans. Some can't get insurance on the job. Others are self-employed, and can't afford it, since buying insurance on your own costs you three times as much as the coverage you get from your employer. Many other Americans who are willing and able to pay are still denied insurance due to previous illnesses or conditions that insurance companies decide are too risky or too expensive to cover. We are the only democracy -- the only advanced democracy on Earth -- the only wealthy nation -- that allows such hardship for millions of its people. There are now more than 30 million American citizens who cannot get coverage. In just a two-year period, one in every three Americans goes without health care coverage at some point. And every day, 14,000 Americans lose their coverage. In other words, it can happen to anyone. But the problem that plagues the health care system is not just a problem for the uninsured. Those who do have insurance have never had less security and stability than they do today. More and more Americans worry that if you move, lose your job, or change your job, you'll lose your health insurance too. More and more Americans pay their premiums, only to discover that their insurance company has dropped their coverage when they get sick, or won't pay the full cost of care. It happens every day.
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One man from Illinois lost his coverage in the middle of chemotherapy because his insurer found that he hadn't reported gallstones that he didn't even know about. They delayed his treatment, and he died because of it. Another woman from Texas was about to get a double mastectomy when her insurance company canceled her policy because she forgot to declare a case of acne. By the time she had her insurance reinstated, her breast cancer had more than doubled in size. That is heart-breaking, it is wrong, and no one should be treated that way in the United States of America. (Applause.) Then there's the problem of rising cost. We spend one and a half times more per person on health care than any other country, but we aren't any healthier for it. This is one of the reasons that insurance premiums have gone up three times faster than wages. It's why so many employers -- especially small businesses -- are forcing their employees to pay more for insurance, or are dropping their coverage entirely. It's why so many aspiring entrepreneurs cannot afford to open a business in the first place, and why American businesses that compete internationally -- like our automakers -- are at a huge disadvantage. And it's why those of us with health insurance are also paying a hidden and growing tax for those without it -- about $1,000 per year that pays for somebody else's emergency room and charitable care. Finally, our health care system is placing an unsustainable burden on taxpayers. When health care costs grow at the rate they have, it puts greater pressure on programs like Medicare and Medicaid. If we do nothing to slow these skyrocketing costs, we will eventually be spending more on Medicare and Medicaid than every other government program combined. Put simply, our health care problem is our deficit problem. Nothing else even comes close. Nothing else. (Applause.) Now, these are the facts. Nobody disputes them. We know we must reform this system. The question is how. There are those on the left who believe that the only way to fix the system is through a single-payer system like Canada's -- (applause) -- where we would severely restrict the private insurance market and have the government provide coverage for everybody. On the right, there are those who argue that we should end employer-based systems and leave individuals to buy health insurance on their own. I've said -- I have to say that there are arguments to be made for both these approaches. But either one would represent a radical shift that would disrupt the health care most people currently have. Since health care represents one-sixth of our economy, I believe it makes more sense to build on what works and fix what doesn't, rather than try to build an entirely new system from scratch. (Applause.) And that is precisely what those of you in Congress have tried to do over the past several months. During that time, we've seen Washington at its best and at its worst. We've seen many in this chamber work tirelessly for the better part of this year to offer thoughtful ideas about how to achieve reform. Of the five committees asked to develop bills, four have completed their work, and the Senate Finance Committee announced today that it will move forward next week. That has never happened before. Our overall efforts have been supported by an unprecedented coalition of doctors and nurses; hospitals, seniors' groups, and even drug companies -- many of whom opposed reform in the past. And there is agreement in this chamber on about 80 percent of what needs to be done, putting us closer to the goal of reform than we have ever been. But what we've also seen in these last months is the same partisan spectacle that only hardens the disdain many Americans have towards their own government. Instead of honest debate, we've seen scare tactics. Some have dug into unyielding ideological camps that offer no hope of compromise. Too many have used this as an opportunity to score short-term political points, even if it robs the country of our opportunity to solve a long-term challenge. And out of this blizzard of charges and counter-charges, confusion has reigned. Well, the time for bickering is over. The time for games has passed. (Applause.) Now is the season for action. Now is when we must bring the best ideas of both parties together, and show the American people that we can still do what we were sent here to do. Now is the time to deliver on health care. Now is the time to deliver on health care. The plan I'm announcing tonight would meet three basic goals. It will provide more security and stability to those who have health insurance. It will provide insurance for those who don't. And it will slow the growth of health care costs for our families, our businesses, and our government. (Applause.) It's a plan that asks everyone to take responsibility for meeting this challenge -- not just government, not just insurance companies, but everybody including employers and individuals. And it's a plan that incorporates ideas from senators and congressmen, from Democrats and Republicans -- and yes, from some of my opponents in both the primary and general election. Here are the details that every American needs to know about this plan. First, if you are among the hundreds of millions of Americans who already have health insurance through your job, or Medicare, or Medicaid, or the VA, nothing in this plan will require you or your employer to change the coverage or the doctor you have. (Applause.) Let me repeat this: Nothing in our plan requires you to change what you have. What this plan will do is make the insurance you have work better for you. Under this plan, it will be against the law for insurance companies to deny you coverage because of a preexisting condition. (Applause.) As soon as I sign this bill, it will be against the law for insurance companies to drop your coverage when you get sick or water it down when you need it the most. (Applause.) They will no longer be able to place some arbitrary cap on the amount of
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coverage you can receive in a given year or in a lifetime. (Applause.) We will place a limit on how much you can be charged for out-of-pocket expenses, because in the United States of America, no one should go broke because they get sick. (Applause.) And insurance companies will be required to cover, with no extra charge, routine checkups and preventive care, like mammograms and colonoscopies -- (applause) -- because there's no reason we shouldn't be catching diseases like breast cancer and colon cancer before they get worse. That makes sense, it saves money, and it saves lives. (Applause.) Now, that's what Americans who have health insurance can expect from this plan -- more security and more stability. Now, if you're one of the tens of millions of Americans who don't currently have health insurance, the second part of this plan will finally offer you quality, affordable choices. (Applause.) If you lose your job or you change your job, you'll be able to get coverage. If you strike out on your own and start a small business, you'll be able to get coverage. We'll do this by creating a new insurance exchange -- a marketplace where individuals and small businesses will be able to shop for health insurance at competitive prices. Insurance companies will have an incentive to participate in this exchange because it lets them compete for millions of new customers. As one big group, these customers will have greater leverage to bargain with the insurance companies for better prices and quality coverage. This is how large companies and government employees get affordable insurance. It's how everyone in this Congress gets affordable insurance. And it's time to give every American the same opportunity that we give ourselves. (Applause.) Now, for those individuals and small businesses who still can't afford the lower-priced insurance available in the exchange, we'll provide tax credits, the size of which will be based on your need. And all insurance companies that want access to this new marketplace will have to abide by the consumer protections I already mentioned. This exchange will take effect in four years, which will give us time to do it right. In the meantime, for those Americans who can't get insurance today because they have preexisting medical conditions, we will immediately offer low-cost coverage that will protect you against financial ruin if you become seriously ill. (Applause.) This was a good idea when Senator John McCain proposed it in the campaign, it's a good idea now, and we should all embrace it. (Applause.) Now, even if we provide these affordable options, there may be those -- especially the young and the healthy -- who still want to take the risk and go without coverage. There may still be companies that refuse to do right by their workers by giving them coverage. The problem is, such irresponsible behavior costs all the rest of us money. If there are affordable options and people still don't sign up for health insurance, it means we pay for these people's expensive emergency room visits. If some businesses don't provide workers health care, it forces the rest of us to pick up the tab when their workers get sick, and gives those businesses an unfair advantage over their competitors. And unless everybody does their part, many of the insurance reforms we seek -- especially requiring insurance companies to cover preexisting conditions -- just can't be achieved. And that's why under my plan, individuals will be required to carry basic health insurance -- just as most states require you to carry auto insurance. (Applause.) Likewise -- likewise, businesses will be required to either offer their workers health care, or chip in to help cover the cost of their workers. There will be a hardship waiver for those individuals who still can't afford coverage, and 95 percent of all small businesses, because of their size and narrow profit margin, would be exempt from these requirements. (Applause.) But we can't have large businesses and individuals who can afford coverage game the system by avoiding responsibility to themselves or their employees. Improving our health care system only works if everybody does their part. And while there remain some significant details to be ironed out, I believe -- (laughter) -- I believe a broad consensus exists for the aspects of the plan I just outlined: consumer protections for those with insurance, an exchange that allows individuals and small businesses to purchase affordable coverage, and a requirement that people who can afford insurance get insurance. And I have no doubt that these reforms would greatly benefit Americans from all walks of life, as well as the economy as a whole. Still, given all the misinformation that's been spread over the past few months, I realize -(applause) -- I realize that many Americans have grown nervous about reform. So tonight I want to address some of the key controversies that are still out there. Some of people's concerns have grown out of bogus claims spread by those whose only agenda is to kill reform at any cost. The best example is the claim made not just by radio and cable talk show hosts, but by prominent politicians, that we plan to set up panels of bureaucrats with the power to kill off senior citizens. Now, such a charge would be laughable if it weren't so cynical and irresponsible. It is a lie, plain and simple. (Applause.) There are also those who claim that our reform efforts would insure illegal immigrants. This, too, is false. The reforms -- the reforms I'm proposing would not apply to those who are here illegally. AUDIENCE MEMBER: You lie! (Boos.) THE PRESIDENT: It's not true. And one more misunderstanding I want to clear up -- under our plan, no federal dollars will be used to fund abortions, and federal conscience laws will remain in place. (Applause.) Now, my health care proposal has also been attacked by some who oppose reform as a "government takeover" of
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the entire health care system. As proof, critics point to a provision in our plan that allows the uninsured and small businesses to choose a publicly sponsored insurance option, administered by the government just like Medicaid or Medicare. (Applause.) So let me set the record straight here. My guiding principle is, and always has been, that consumers do better when there is choice and competition. That's how the market works. (Applause.) Unfortunately, in 34 states, 75 percent of the insurance market is controlled by five or fewer companies. In Alabama, almost 90 percent is controlled by just one company. And without competition, the price of insurance goes up and quality goes down. And it makes it easier for insurance companies to treat their customers badly -- by cherry-picking the healthiest individuals and trying to drop the sickest, by overcharging small businesses who have no leverage, and by jacking up rates. Insurance executives don't do this because they're bad people; they do it because it's profitable. As one former insurance executive testified before Congress, insurance companies are not only encouraged to find reasons to drop the seriously ill, they are rewarded for it. All of this is in service of meeting what this former executive called "Wall Street's relentless profit expectations." Now, I have no interest in putting insurance companies out of business. They provide a legitimate service, and employ a lot of our friends and neighbors. I just want to hold them accountable. (Applause.) And the insurance reforms that I've already mentioned would do just that. But an additional step we can take to keep insurance companies honest is by making a not-for-profit public option available in the insurance exchange. (Applause.) Now, let me be clear. Let me be clear. It would only be an option for those who don't have insurance. No one would be forced to choose it, and it would not impact those of you who already have insurance. In fact, based on Congressional Budget Office estimates, we believe that less than 5 percent of Americans would sign up. Despite all this, the insurance companies and their allies don't like this idea. They argue that these private companies can't fairly compete with the government. And they'd be right if taxpayers were subsidizing this public insurance option. But they won't be. I've insisted that like any private insurance company, the public insurance option would have to be self-sufficient and rely on the premiums it collects. But by avoiding some of the overhead that gets eaten up at private companies by profits and excessive administrative costs and executive salaries, it could provide a good deal for consumers, and would also keep pressure on private insurers to keep their policies affordable and treat their customers better, the same way public colleges and universities provide additional choice and competition to students without in any way inhibiting a vibrant system of private colleges and universities. (Applause.) Now, it is -- it's worth noting that a strong majority of Americans still favor a public insurance option of the sort I've proposed tonight. But its impact shouldn't be exaggerated -- by the left or the right or the media. It is only one part of my plan, and shouldn't be used as a handy excuse for the usual Washington ideological battles. To my progressive friends, I would remind you that for decades, the driving idea behind reform has been to end insurance company abuses and make coverage available for those without it. (Applause.) The public option -- the public option is only a means to that end -- and we should remain open to other ideas that accomplish our ultimate goal. And to my Republican friends, I say that rather than making wild claims about a government takeover of health care, we should work together to address any legitimate concerns you may have. (Applause.) For example -- for example, some have suggested that the public option go into effect only in those markets where insurance companies are not providing affordable policies. Others have proposed a co-op or another non-profit entity to administer the plan. These are all constructive ideas worth exploring. But I will not back down on the basic principle that if Americans can't find affordable coverage, we will provide you with a choice. (Applause.) And I will make sure that no government bureaucrat or insurance company bureaucrat gets between you and the care that you need. (Applause.) Finally, let me discuss an issue that is a great concern to me, to members of this chamber, and to the public -- and that's how we pay for this plan. And here's what you need to know. First, I will not sign a plan that adds one dime to our deficits -- either now or in the future. (Applause.) I will not sign it if it adds one dime to the deficit, now or in the future, period. And to prove that I'm serious, there will be a provision in this plan that requires us to come forward with more spending cuts if the savings we promised don't materialize. (Applause.) Now, part of the reason I faced a trillion-dollar deficit when I walked in the door of the White House is because too many initiatives over the last decade were not paid for -- from the Iraq war to tax breaks for the wealthy. (Applause.) I will not make that same mistake with health care. Second, we've estimated that most of this plan can be paid for by finding savings within the existing health care system, a system that is currently full of waste and abuse. Right now, too much of the hard-earned savings and tax dollars we spend on health care don't make us any healthier. That's not my judgment -- it's the judgment of medical professionals across this country. And this is also true when it comes to Medicare and Medicaid. In fact, I want to speak directly to seniors for a moment, because Medicare is another issue that's been subjected to demagoguery and distortion during the course of this debate. More than four decades ago, this nation stood up for the principle that after a lifetime of hard work, our seniors should not be left to struggle with a pile of medical bills in their later years. That's how Medicare was born. And it remains a sacred trust that must be passed down from one generation to the next. (Applause.) And that is why not
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a dollar of the Medicare trust fund will be used to pay for this plan. (Applause.) The only thing this plan would eliminate is the hundreds of billions of dollars in waste and fraud, as well as unwarranted subsidies in Medicare that go to insurance companies -- subsidies that do everything to pad their profits but don't improve the care of seniors. And we will also create an independent commission of doctors and medical experts charged with identifying more waste in the years ahead. (Applause.) Now, these steps will ensure that you -- America's seniors -- get the benefits you've been promised. They will ensure that Medicare is there for future generations. And we can use some of the savings to fill the gap in coverage that forces too many seniors to pay thousands of dollars a year out of their own pockets for prescription drugs. (Applause.) That's what this plan will do for you. So don't pay attention to those scary stories about how your benefits will be cut, especially since some of the same folks who are spreading these tall tales have fought against Medicare in the past and just this year supported a budget that would essentially have turned Medicare into a privatized voucher program. That will not happen on my watch. I will protect Medicare. (Applause.)
Now, because Medicare is such a big part of the health care system, making the program more efficient can help usher in changes in the way we deliver health care that can reduce costs for everybody. We have long known that some places -- like the Intermountain Healthcare in Utah or the Geisinger Health System in rural Pennsylvania -offer high-quality care at costs below average. So the commission can help encourage the adoption of these common-sense best practices by doctors and medical professionals throughout the system -- everything from reducing hospital infection rates to encouraging better coordination between teams of doctors. Reducing the waste and inefficiency in Medicare and Medicaid will pay for most of this plan. (Applause.) Now, much of the rest would be paid for with revenues from the very same drug and insurance companies that stand to benefit from tens of millions of new customers. And this reform will charge insurance companies a fee for their most expensive policies, which will encourage them to provide greater value for the money -- an idea which has the support of Democratic and Republican experts. And according to these same experts, this modest change could help hold down the cost of health care for all of us in the long run. Now, finally, many in this chamber -- particularly on the Republican side of the aisle -- have long insisted that reforming our medical malpractice laws can help bring down the cost of health care. (Applause.) Now -- there you go. There you go. Now, I don't believe malpractice reform is a silver bullet, but I've talked to enough doctors to know that defensive medicine may be contributing to unnecessary costs. (Applause.) So I'm proposing that we move forward on a range of ideas about how to put patient safety first and let doctors focus on practicing medicine. (Applause.) I know that the Bush administration considered authorizing demonstration projects in individual states to test these ideas. I think it's a good idea, and I'm directing my Secretary of Health and Human Services to move forward on this initiative today. (Applause.) Now, add it all up, and the plan I'm proposing will cost around $900 billion over 10 years -- less than we have spent on the Iraq and Afghanistan wars, and less than the tax cuts for the wealthiest few Americans that Congress passed at the beginning of the previous administration. (Applause.) Now, most of these costs will be paid for with money already being spent -- but spent badly -- in the existing health care system. The plan will not add to our deficit. The middle class will realize greater security, not higher taxes. And if we are able to slow the growth of health care costs by just one-tenth of 1 percent each year -- one-tenth of 1 percent -- it will actually reduce the deficit by $4 trillion over the long term. Now, this is the plan I'm proposing. It's a plan that incorporates ideas from many of the people in this room tonight -Democrats and Republicans. And I will continue to seek common ground in the weeks ahead. If you come to me with a serious set of proposals, I will be there to listen. My door is always open. But know this: I will not waste time with those who have made the calculation that it's better politics to kill this plan than to improve it. (Applause.) I won't stand by while the special interests use the same old tactics to keep things exactly the way they are. If you misrepresent what's in this plan, we will call you out. (Applause.) And I will not -and I will not accept the status quo as a solution. Not this time. Not now. Everyone in this room knows what will happen if we do nothing. Our deficit will grow. More families will go bankrupt. More businesses will close. More Americans will lose their coverage when they are sick and need it the most. And more will die as a result. We know these things to be true. That is why we cannot fail. Because there are too many Americans counting on us to succeed -- the ones who suffer silently, and the ones who shared their stories with us at town halls, in e-mails, and in letters. I received one of those letters a few days ago. It was from our beloved friend and colleague, Ted Kennedy. He had written it back in May, shortly after he was told that his illness was terminal. He asked that it be delivered upon his death. In it, he spoke about what a happy time his last months were, thanks to the love and support of family and friends, his wife, Vicki, his amazing children, who are all here tonight. And he expressed confidence that this would be the year that health care reform -- "that great unfinished business of our society," he called it -- would finally pass. He
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repeated the truth that health care is decisive for our future prosperity, but he also reminded me that "it concerns more than material things." "What we face," he wrote, "is above all a moral issue; at stake are not just the details of policy, but fundamental principles of social justice and the character of our country." I've thought about that phrase quite a bit in recent days -- the character of our country. One of the unique and wonderful things about America has always been our self-reliance, our rugged individualism, our fierce defense of freedom and our healthy skepticism of government. And figuring out the appropriate size and role of government has always been a source of rigorous and, yes, sometimes angry debate. That's our history.
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For some of Ted Kennedy's critics, his brand of liberalism represented an affront to American liberty. In their minds, his passion for universal health care was nothing more than a passion for big government.
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On issues like these, Ted Kennedy's passion was born not of some rigid ideology, but of his own experience. It was the experience of having two children stricken with cancer. He never forgot the sheer terror and helplessness that any parent feels when a child is badly sick. And he was able to imagine what it must be like for those without
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But those of us who knew Teddy and worked with him here -- people of both parties -- know that what drove him was something more. His friend Orrin Hatch -- he knows that. They worked together to provide children with health insurance. His friend John McCain knows that. They worked together on a Patient's Bill of Rights. His friend Chuck Grassley knows that. They worked together to provide health care to children with disabilities.
That large-heartedness -- that concern and regard for the plight of others -- is not a partisan feeling. It's not a Republican or a Democratic feeling. It, too, is part of the American character -- our ability to stand in other people's shoes; a recognition that we are all in this together, and when fortune turns against one of us, others are there to lend a helping hand; a belief that in this country, hard work and responsibility should be rewarded by some measure of security and fair play; and an acknowledgment that sometimes government has to step in to help deliver on that promise.
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This has always been the history of our progress. In 1935, when over half of our seniors could not support themselves and millions had seen their savings wiped away, there were those who argued that Social Security would lead to socialism, but the men and women of Congress stood fast, and we are all the better for it. In 1965, when some argued that Medicare represented a government takeover of health care, members of Congress -Democrats and Republicans -- did not back down. They joined together so that all of us could enter our golden years with some basic peace of mind.
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Our Gov ernm ent You see, our predecessors understood that government could not, and should not, solve every problem. They understood that there are instances when the gains in security from government action are not worth the added constraints on our freedom. But they also understood that the danger of too much government is matched by the perils of too little; that without the leavening hand of wise policy, markets can crash, monopolies can stifle competition, the vulnerable can be exploited. And they knew that when any government measure, no matter how carefully crafted or beneficial, is subject to scorn; when any efforts to help people in need are attacked as un-American; when facts and reason are thrown overboard and only timidity passes for wisdom, and we can no longer even engage in a civil conversation with each other over the things that truly matter -- that at that point we don't merely lose our capacity to solve big challenges. We lose something essential about ourselves.
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That was true then. It remains true today. I understand how difficult this health care debate has been. I know that many in this country are deeply skeptical that government is looking out for them. I understand that the politically safe move would be to kick the can further down the road -- to defer reform one more year, or one more election, or one more term. But that is not what the moment calls for. That's not what we came here to do. We did not come to fear the future. We came here to shape it. I still believe we can act even when it's hard. (Applause.) I still believe -- I still believe that we can act when it's hard. I still believe we can replace acrimony with civility, and gridlock with progress. I still believe we can do great things, and that here and now we will meet history's test. Because that's who we are. That is our calling. That is our character. Thank you, God bless you, and may God bless the United States of America. (Applause.) END
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Appendix C: Every Human Has Rights Declaration
United Nations' Universal Declaration of Human Rights, est. December 10, 1948 OnDecember10th,1948,thenewlyformedUnitedNationsadoptedauniversaldeclarationthattranscended culturalandnationalboundaries.TheUniversalDeclarationofHumanRightsestablishedacommonstandardfor humanachievementforallpeoplesandallnations;rootedinthevaluesoffreedom,equality,solidarity,tolerance, respectandsharedresponsibility. UniversalDeclarationofHumanRights Preamble Whereasrecognitionoftheinherentdignityandoftheequalandinalienablerightsofallmembersofthehuman familyisthefoundationoffreedom,justiceandpeaceintheworld, Whereasdisregardandcontemptforhumanrightshaveresultedinbarbarousactswhichhaveoutragedthe conscienceofmankind,andtheadventofaworldinwhichhumanbeingsshallenjoyfreedomofspeechandbelief andfreedomfromfearandwanthasbeenproclaimedasthehighestaspirationofthecommonpeople, Whereasitisessential,ifmanisnottobecompelledtohaverecourse,asalastresort,torebellionagainsttyranny andoppression,thathumanrightsshouldbeprotectedbytheruleoflaw, Whereasitisessentialtopromotethedevelopmentoffriendlyrelationsbetweennations, WhereasthepeoplesoftheUnitedNationshaveintheCharterreaffirmedtheirfaithinfundamentalhuman rights,inthedignityandworthofthehumanpersonandintheequalrightsofmenandwomenandhave determinedtopromotesocialprogressandbetterstandardsoflifeinlargerfreedom, WhereasMemberStateshavepledgedthemselvestoachieve,incooperationwiththeUnitedNations,the promotionofuniversalrespectforandobservanceofhumanrightsandfundamentalfreedoms, Whereasacommonunderstandingoftheserightsandfreedomsisofthegreatestimportanceforthefull realizationofthispledge, Now,therefore, TheGeneralAssembly, ProclaimsthisUniversalDeclarationofHumanRightsasacommonstandardofachievementforallpeoplesand allnations,totheendthateveryindividualandeveryorganofsociety,keepingthisDeclarationconstantlyin mind,shallstrivebyteachingandeducationtopromoterespectfortheserightsandfreedomsandbyprogressive measures,nationalandinternational,tosecuretheiruniversalandeffectiverecognitionandobservance,both amongthepeoplesofMemberStatesthemselvesandamongthepeoplesofterritoriesundertheirjurisdiction. Article1.Allhumanbeingsarebornfreeandequalindignityandrights.Theyareendowedwithreasonand conscienceandshouldacttowardsoneanotherinaspiritofbrotherhood.
Source: Retrieved September 14, 2009, from www.everyhumanhasrights.org/universal-declaration/read-it
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Appendix C: Every Human Has Rights Declaration (cont.)
Article2.EveryoneisentitledtoalltherightsandfreedomssetforthinthisDeclaration,withoutdistinctionof anykind,suchasrace,colour,sex,language,religion,politicalorotheropinion,nationalorsocialorigin,property, birthorotherstatus. Furthermore,nodistinctionshallbemadeonthebasisofthepolitical,jurisdictionalorinternationalstatusofthe countryorterritorytowhichapersonbelongs,whetheritbeindependent,trust,nonselfgoverningorunderany otherlimitationofsovereignty. Article3.Everyonehastherighttolife,libertyandsecurityofperson. Article4.Nooneshallbeheldinslaveryorservitude;slaveryandtheslavetradeshallbeprohibitedinalltheir forms. Article5.Nooneshallbesubjectedtotortureortocruel,inhumanordegradingtreatmentorpunishment. Article6.Everyonehastherighttorecognitioneverywhereasapersonbeforethelaw. Article7.Allareequalbeforethelawandareentitledwithoutanydiscriminationtoequalprotectionofthelaw. AllareentitledtoequalprotectionagainstanydiscriminationinviolationofthisDeclarationandagainstany incitementtosuchdiscrimination. Article8.Everyonehastherighttoaneffectiveremedybythecompetentnationaltribunalsforactsviolatingthe fundamentalrightsgrantedhimbytheconstitutionorbylaw. Article9.Nooneshallbesubjectedtoarbitraryarrest,detentionorexile. Article10.Everyoneisentitledinfullequalitytoafairandpublichearingbyanindependentandimpartial tribunal,inthedeterminationofhisrightsandobligationsandofanycriminalchargeagainsthim. Article11.1.Everyonechargedwithapenaloffencehastherighttobepresumedinnocentuntilprovedguilty accordingtolawinapublictrialatwhichhehashadalltheguaranteesnecessaryforhisdefense. 2.Nooneshallbeheldguiltyofanypenaloffenceonaccountofanyactoromissionwhichdidnotconstitutea penaloffence,undernationalorinternationallaw,atthetimewhenitwascommitted.Norshallaheavierpenalty beimposedthantheonethatwasapplicableatthetimethepenaloffencewascommitted. Article12.Nooneshallbesubjectedtoarbitraryinterferencewithhisprivacy,family,homeorcorrespondence, nortoattacksuponhishonorandreputation.Everyonehastherighttotheprotectionofthelawagainstsuch interferenceorattacks. Article13.1.EveryonehastherighttofreedomofmovementandresidencewithinthebordersofeachState. 2.Everyonehastherighttoleaveanycountry,includinghisown,andtoreturntohiscountry. Article14.1.Everyonehastherighttoseekandtoenjoyinothercountriesasylumfrompersecution. 2.Thisrightmaynotbeinvokedinthecaseofprosecutionsgenuinelyarisingfromnonpoliticalcrimesorfrom actscontrarytothepurposesandprinciplesoftheUnitedNations.
Source: Retrieved September 14, 2009, from www.everyhumanhasrights.org/universal-declaration/read-it
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Appendix C: Every Human Has Rights Declaration (cont.)
Article15.1.Everyonehastherighttoanationality. 2.Nooneshallbearbitrarilydeprivedofhisnationalitynordeniedtherighttochangehisnationality. Article16.1.Menandwomenoffullage,withoutanylimitationduetorace,nationalityorreligion,havetheright tomarryandtofoundafamily.Theyareentitledtoequalrightsastomarriage,duringmarriageandatits dissolution. 2.Marriageshallbeenteredintoonlywiththefreeandfullconsentoftheintendingspouses. 3.Thefamilyisthenaturalandfundamentalgroupunitofsocietyandisentitledtoprotectionbysocietyandthe State. Article17.1.Everyonehastherighttoownpropertyaloneaswellasinassociationwithothers. 2.Nooneshallbearbitrarilydeprivedofhisproperty. Article18.Everyonehastherighttofreedomofthought,conscienceandreligion;thisrightincludesfreedomto changehisreligionorbelief,andfreedom,eitheraloneorincommunitywithothersandinpublicorprivate,to manifesthisreligionorbeliefinteaching,practice,worshipandobservance. Article19.Everyonehastherighttofreedomofopinionandexpression;thisrightincludesfreedomtohold opinionswithoutinterferenceandtoseek,receiveandimpartinformationandideasthroughanymediaand regardlessoffrontiers. Article20.1.Everyonehastherighttofreedomofpeacefulassemblyandassociation. 2.Noonemaybecompelledtobelongtoanassociation. Article21.1.Everyonehastherighttotakepartinthegovernmentofhiscountry,directlyorthroughfreely chosenrepresentatives. 2.Everyonehastherighttoequalaccesstopublicserviceinhiscountry. 3.Thewillofthepeopleshallbethebasisoftheauthorityofgovernment;thiswillshallbeexpressedinperiodic andgenuineelectionswhichshallbebyuniversalandequalsuffrageandshallbeheldbysecretvoteorby equivalentfreevotingprocedures. Article22.Everyone,asamemberofsociety,hastherighttosocialsecurityandisentitledtorealization,through nationaleffortandinternationalcooperationandinaccordancewiththeorganizationandresourcesofeach State,oftheeconomic,socialandculturalrightsindispensableforhisdignityandthefreedevelopmentofhis personality. Article23.1.Everyonehastherighttowork,tofreechoiceofemployment,tojustandfavorableconditionsof workandtoprotectionagainstunemployment. 2.Everyone,withoutanydiscrimination,hastherighttoequalpayforequalwork. 3.Everyonewhoworkshastherighttojustandfavorableremunerationensuringforhimselfandhisfamilyan existenceworthyofhumandignity,andsupplemented,ifnecessary,byothermeansofsocialprotection.
Source: Retrieved September 14, 2009, from www.everyhumanhasrights.org/universal-declaration/read-it
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Appendix C: Every Human Has Rights Declaration (cont.)
4.Everyonehastherighttoformandtojointradeunionsfortheprotectionofhisinterests. Article24.Everyonehastherighttorestandleisure,includingreasonablelimitationofworkinghoursand periodicholidayswithpay. Article25.1.Everyonehastherighttoastandardoflivingadequateforthehealthandwellbeingofhimselfand ofhisfamily,includingfood,clothing,housingandmedicalcareandnecessarysocialservices,andtherightto securityintheeventofunemployment,sickness,disability,widowhood,oldageorotherlackoflivelihoodin circumstancesbeyondhiscontrol. 2.Motherhoodandchildhoodareentitledtospecialcareandassistance.Allchildren,whetherborninoroutof wedlock,shallenjoythesamesocialprotection. Article26.1.Everyonehastherighttoeducation.Educationshallbefree,atleastintheelementaryand fundamentalstages.Elementaryeducationshallbecompulsory.Technicalandprofessionaleducationshallbe madegenerallyavailableandhighereducationshallbeequallyaccessibletoallonthebasisofmerit. 2.Educationshallbedirectedtothefulldevelopmentofthehumanpersonalityandtothestrengtheningof respectforhumanrightsandfundamentalfreedoms.Itshallpromoteunderstanding,toleranceandfriendship amongallnations,racialorreligiousgroups,andshallfurthertheactivitiesoftheUnitedNationsforthe maintenanceofpeace. 3.Parentshaveapriorrighttochoosethekindofeducationthatshallbegiventotheirchildren. Article27.1.Everyonehastherightfreelytoparticipateintheculturallifeofthecommunity,toenjoythearts andtoshareinscientificadvancementanditsbenefits. 2.Everyonehastherighttotheprotectionofthemoralandmaterialinterestsresultingfromanyscientific, literaryorartisticproductionofwhichheistheauthor. Article28.Everyoneisentitledtoasocialandinternationalorderinwhichtherightsandfreedomssetforthin thisDeclarationcanbefullyrealized. Article29.1.Everyonehasdutiestothecommunityinwhichalonethefreeandfulldevelopmentofhis personalityispossible. 2.Intheexerciseofhisrightsandfreedoms,everyoneshallbesubjectonlytosuchlimitationsasaredetermined bylawsolelyforthepurposeofsecuringduerecognitionandrespectfortherightsandfreedomsofothersandof meetingthejustrequirementsofmorality,publicorderandthegeneralwelfareinademocraticsociety. 3.TheserightsandfreedomsmayinnocasebeexercisedcontrarytothepurposesandprinciplesoftheUnited Nations. Article30.NothinginthisDeclarationmaybeinterpretedasimplyingforanyState,grouporpersonanyrightto engageinanyactivityortoperformanyactaimedatthedestructionofanyoftherightsandfreedomssetforth herein.
Source: Retrieved September 14, 2009, from www.everyhumanhasrights.org/universal-declaration/read-it
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Appendix D: Key Aspects of a Sustainable Healthcare System
GLAXOSMITHKLINE
BRIEFI NGS
Key Aspects of a Sustainable Healthcare System Introduction Governments across the world are looking for ways to bring into balance a number of competing policy goals: economic growth; industrial development; attraction of foreign direct investment; advances in education, science and technology; overall budgetary control; complex and evolving healthcare needs. Balancing options is especially hard in the area of healthcare. Market-based pricing for reimbursed pharmaceuticals, in which companies are free to set prices and there are no supply-side or demand-side controls, remains the industry’s preferred solution to meeting the needs of patients and society’s demand for better medical treatment. However, markets in Europe and the International region tend instead to be characterized by monopsonistic payer structures, over-regulation, poor resource allocation, slow access for new medicines, and a focus on cost rather than value. Against this background, this paper outlines the elements which GSK believes most effectively deliver sustainable and efficient healthcare systems. Not all of these elements may be relevant or appropriate to every country. However, governments are urged to review some, if not all of them, as they consider how best to meet the challenge of establishing a healthcare policy that meets the needs of all key stakeholders, namely patients (who want rapid access to the best treatments), payers (who want to deliver good healthcare to their citizens and manage budgets) and the industry (which wants to secure a return on investment that will incentivise further innovation). Key Elements 1.
Healthcare priorities should be identified through improved and earlier dialogue
National healthcare systems and policies should ensure that the right capabilities are put in place for defining treatment priorities within each individual disease area and for identifying disease management targets. Industry and government should discuss these health priorities and targets as part of a 10-20 year strategic agenda and not just as part of cost containment measures over the next 6 months. This will enable the development of new medicines, to help ensure that unmet need is addressed, disease prioritisation is clear and patients get access to the medicines that will improve their lives.
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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Appendix D: Key Aspects of a Sustainable Healthcare System (cont.)
GLAXOSMITHKLINE
BRIEFINGS
Predictability is created by earlier and more in-depth interaction with healthcare payers to discuss specific data that payers require in order to decide on the reimbursement of a product. At present, dialogue generally starts once a medicine has been approved and the data generated. It is often conducted in a manner that lacks predictability and coherence. 2.
Healthcare funding should be adequate and sustainable
Resources should be allocated where quality is achieved and outcomes are maximised. Ways of achieving this include: x x
x
x
x x
x
x
x
improved prevention. Chronic diseases are among the most prevalent, costly and preventable of all healthcare problems. By encouraging prevention, healthcare will be improved and huge healthcare spending avoided. driving out waste. Efficient practice (prevention, diagnosis, treatment, rehabilitation) will lead to savings for the healthcare system as a whole. With respect to pharmaceuticals, policies for proper usage of medicines in both qualitative and quantitative terms should be promoted and implemented, with a view to freeing up resources for use elsewhere in the system. integrating care of chronic diseases and viewing drug budgets in the context of healthcare overall. Silo-budgeting should be eliminated because a focus on medicines expenditure leads governments to seek a disproportionate contribution to cost containment from pharmaceuticals. developing a greater awareness of the cost-effectiveness of innovative medicines. For example, an increase in medicines spending in the treatment of Alzheimer’s can lead to greater overall savings. Governments should identify and target savings and redirect expenditure towards innovative drugs. recognising the importance and value of comprehensive vaccination programmes in the context of investing in cost-effective preventative care taking account of the existence and benefits of new technologies. The benefits can refer to their cost-efficiency in relation to hospital-based interventions or to advantages for patients in terms of convenience, improved quality of life etc. A focus on cost, rather than value, will not meet the budgetary goals of governments. strengthening/establishing primary care services and avoiding misuse and overuse of medical services; an ambulatory care system should be developed. This includes a GP referral system, the development of community care centres with focus on health promotion and disease prevention, and further development of the role of pharmacists. reassessing the organisation of hospitals and the number of acute hospital beds in light of current medical needs and available technologies; innovative therapies and medicines can reduce the length of stay or avoid hospitalisation and should therefore be encouraged. promoting appropriate use of over-the-counter/self medication products : Governments should encourage the appropriate use of self medication products as a means of relieving pressure on public healthcare systems (ie. physician appointments) and of freeing up financial resources for innovative products.
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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Appendix D: Key Aspects of a Sustainable Healthcare System (cont.)
GLAXOSMITHKLINE
BRIEFINGS
New funding sources for healthcare should be considered: Systems in which the government is the sole purchaser of medicines are likely to be unsustainable in the medium to long-term. Governments should look at new funding options, including; x x
x
a greater role for private health insurance increased patient co-payment, in a way that encourages compliance and cost-effective use of medicines while ensuring that low-income and other vulnerable groups are not excluded or discouraged from seeking and receiving medical care. Any move to a situation where people are prepared or required to contribute more to healthcare costs will require a process of education and communication, especially in view of the fact that currently patients remain reticent to pay additional charges to their prescription. There is a clear risk that patients perceive that a medicine’s value is somehow questionable if the Government does not fully reimburse it. new or increased taxation on products and behaviours, like fast foods and smoking, which increase healthcare costs. Tax revenues from these sources should be dedicated to healthcare budgets.
An acceptance by citizens that they need to pay more for healthcare is critical. Shifting more costs onto consumers of healthcare will make them more demanding, hungrier for information and more sensitive to value. Together patients and doctors can work on adopting the most cost-effective treatments and thereby help to reduce the inefficient use of healthcare facilities. 3. Pricing and Reimbursement policies should reflect the true value of “innovation”. Society is on the brink of a new era in which pharmaceutical research in genomics and pharmacogenetics will yield an entirely new class of medical interventions with respect to prevention, detection, treatment and cure. This will throw a radically new light on the concept of effectiveness (tailored medicine with much higher rates of success) and cost (tailored medicine instead of one-size fits all). The nature of drug development, however, remains highly unpredictable. There is no guarantee that the first drug to market will be the best. Some new medicines will be revolutionary breakthroughs. Others will deliver incremental benefits over existing treatments, be it in efficacy, improved tolerability or improved mode of administration. Products that deliver incremental innovation provide alternatives for patients that do not respond well to the first product in class. They also create competition, thereby driving price and value optimisation and provide the path to more radical change Where payers seek value for money, pharmaceutical companies require money for value. The reward society gives to an innovative medicine must reflect its added therapeutic value. Reward for innovation can come in different forms, not just a premium price - e.g. unrestricted access to the patient population defined as needing new therapy, therapeutic guidelines recognising a new therapy, and speed of access.
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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Appendix D: Key Aspects of a Sustainable Healthcare System (cont.)
GLAXOSMITHKLINE
BRIEFINGS
Products should not be punished for success – high volume, and high favourability with prescribers, should not make products the targets for cuts. Payers should not increase volumes for proven value only to reduce price. Reimbursement systems should reward medicines by taking into account measures of success, (whether these are available at launch or during a product’s life-cycle) and that are in line with the way markets function ie. quality, health outcome evidence, physicians’ prescribing etc. Rather than being dominated by short-termism and ad-hoc measures, pricing and reimbursement systems must allow business planning for long-term supply of medicines and encourage R&D investment in medicines that count. 4. Tools for measuring “innovation” should be appropriate The evaluation of a medicine’s value must deliver a reasonable balance between the interests of payers (better management of budgets), patients (better access and outcomes), physicians (better outcomes), and industry (appropriate reward for innovation). Health technology assessment (HTA) is one of the tools, when appropriately defined and applied, that can contribute to an assessment of clinical effectiveness and cost-effectiveness of new medicines and new technologies (including medical devices). Certain key principles should underpin any HTA system. x x
x x x x
x
the process should be inclusive and involve early dialogue with industry around the aims and priorities of the process. there should be clarity and consensus on the criteria against which therapeutic progress (or value) can be measured throughout a product’s lifecycle. The measures of value can include: mortality and morbidity data, side-effects, tolerability, predictive surrogate parameters, pharmaceutical form, route of application, compliance, ease of use, impact on the healthcare service, disease severity, medical need, quality of life, and patient preferences. the evaluation process should be independent, transparent and scientifically robust. Where HTAs are focussed on delivering guidance, the evaluating body should be independent of the payer. evaluation systems should be clear and consistent with regards to methodology, criteria used and data required – this would include clear timeframes for the evaluation and for any decisions arising from it patients, physicians and the industry should be involved in the assessment process, to allow for a better evaluation of the balance between benefits, costs and risk. pharmaceutical companies should be able to submit health outcomes information to the relevant government bodies throughout a product’s lifecycle. This evidence should then receive appropriate attention and reward from payers. A ‘one size fits all’ approach to the timing of appraisals fails to take account of the complexity of conducting assessments and ignores differences in treatments and therapeutic areas. the HTA should be separate from the regulatory review for the grant of a marketing authorisation. Regulatory review must be based on objective and scientifically verifiable criteria of efficacy, safety and quality. HTA should not become a fourth hurdle in marketing authorisation.
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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Appendix D: Key Aspects of a Sustainable Healthcare System (cont.)
GLAXOSMITHKLINE
BRIEFINGS
5. Increased access to information for patients should be actively encouraged Citizens and patients should be at the centre of many key aspects of healthcare as well as medicines policy – such as assessments of value, decisions on access, and allocation of funding. This can only work, however, if there is sufficient information available to them patients should be given the ability to make choices, and should receive the information to choose wisely. Industry should be involved in this initiative. Disease education and vaccines information campaigns are an example of how responsible, approved information from the industry to the public can fulfil a number of objectives: raising public awareness of the existence of a safe and effective vaccine; educating the public of the risks attached to non-vaccination; allowing important savings to be achieved for healthcare systems by preventing disease; and contributing to the overall "wellness" of society. 6.
Free pricing for non-reimbursed medicines should be allowed
When governments negotiate, they should only negotiate for the prices of what they purchase or reimburse; sales outside the state system should be subject to the normal rules of market pricing. 7.
Generics should play an appropriate part in treatment options
Appropriate use of generics can deliver savings in healthcare expenditure and free up resources to reward innovation. However, a more competitive market is required to enable generics to yield the savings they promise. It is estimated that if the OECD utilised generics at the same rate and prices as in the US, savings of $5-30bn annually could result. To this end: x
x
generics should be commoditised, reflecting the limited innovation and investment that goes into their development. Price differences between generics and branded medicines should be visible and sufficiently large to allow healthcare systems to fully benefit from savings created by the use of generics. generic substitution should be used by governments and other payers to free up resources to reward innovation. Provided that physicians can make exceptions on medical grounds, a generics policy, including a system that encourages competitive generic prices, will free up resources that should be used to reward innovation.
8. Use of OTC products should be encouraged Policies encouraging the use of over-the-counter medicines should be actively implemented where medicines provide a clear health benefit to patients and are sufficiently safe to warrant OTC status. These policies should include Government support for products with a long history of safe use being switched from prescription to non-prescription. The advertising and promotion of these products should also be liberalised.
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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Appendix D: Key Aspects of a Sustainable Healthcare System (cont.)
GLAXOSMITHKLINE
9.
BRIEFINGS
Effective regulatory systems should be established
A well-regarded registration process for new pharmaceutical products that enables medicines to gain international credibility by passing stringent criteria on quality, safety and efficacy will encourage pharmaceutical companies to conduct clinical trials and launch innovative products early. Key regulations should be conducive to the development and early adoption of innovative new drugs. 10.
IP should be respected
A strong legal framework on intellectual property rights creates a desirable environment for research and development. Enactment and enforcement of international patent protection and registration data exclusivity to reward innovation and allow funding of R&D in an era of escalating technology development costs is a key factor. September 2006
Source: Retrieved October 24, 2009, from www.gsk.com/policies/GSK-and-key-aspects-of-a-sustainable-healthcare-system.pdf
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Appendix E: 2009 Notice of Annual GlaxoSmithKline Shareholder Meeting
GlaxoSmithKline plc Notice of Annual General Meeting 2.30pm on Wednesday, 20th May 2009
This document is important and requires your immediate attention. If you are in any doubt as to what action you should take, you should consult your stockbroker, bank manager, solicitor, accountant or other professional advisor immediately. If you have sold or otherwise transferred all of your shares, please pass this document, together with the accompanying documents, to the purchaser or transferee, or to the person who arranged the sale or transfer so they can pass these documents to the person who now holds the shares.
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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Appendix E: 2009 Notice of Annual GlaxoSmithKline Shareholder Meeting 24th March 2009 To the holders of the company’s Ordinary shares and American Depositary Shares and, for information, to the holders of the SmithKline Beecham plc Floating Rate Unsecured Loan Stock. Dear Shareholder, Annual General Meeting 2009 I am pleased to enclose the Notice of Meeting for the ninth Annual General Meeting (the “AGM”) of GlaxoSmithKline plc together with the 2008 Annual Report and 2008 Summary. The AGM will be held at 2.30pm on Wednesday, 20th May 2009 at the Queen Elizabeth II Conference Centre, Broad Sanctuary, Westminster, London SW1P 3EE. If you will not be attending, you may appoint a proxy electronically via www.shareview. co.uk or www.sharevote.co.uk or if you hold your shares in CREST via the CREST system or by completing and returning the enclosed form of proxy. In each case, notice of your appointment of a proxy should reach the company’s registrars no later than 2.30pm on Monday, 18th May 2009. A resolution referring to the Financial Statements is included in the ordinary business of the AGM. Our Articles of Association require that certain of our current Directors retire by rotation. I therefore ask you to support the re-election of Mr Larry Culp, Sir Crispin Davis, Dr Moncef Slaoui and Mr Tom de Swaan who will each retire and offer themselves for re-election. Sir Ian Prosser and Dr Schmitz will also be retiring, but will not be seeking re-election. They are to retire from the Board at the end of the AGM. In addition, a resolution is proposed covering the formal election of a new Non-Executive Director, Mr James Murdoch, who has been appointed to the Board with effect from 20th May 2009. Resolutions are proposed in the special business of the AGM to approve the adoption of three new share-based remuneration plans: the GlaxoSmithKline 2009 Performance Share Plan, the GlaxoSmithKline 2009 Share Option Plan and the GlaxoSmithKline 2009 Deferred Annual Bonus Plan, as part of the new Remuneration Policy. Full details of how these plans will be implemented under the new policy can be found in the 2008 Annual Report. The key terms of the new plans are set out in the explanatory notes on pages 14 to 20 of the Notice of Meeting. In addition, resolutions are proposed to retain a notice period for general meetings other than an AGM of 14 days in preparation for the implementation of the EU Shareholder Rights Directive and, following the implementation of the Companies Act 2006, to omit from the published copies of the company’s 2009 Annual Report, the name of the individual who signs the Auditors’ reports on behalf of GSK’s Auditors. Explanatory notes for all the business of the AGM are given on pages 10 to 20 of this document. Recommendation Your Board believes that the resolutions contained in the Notice of Meeting are in the best interests of the company and shareholders as a whole and recommends you to vote in favour of them, as your Directors intend to do in respect of their beneficial shareholdings. Yours sincerely,
Sir Christopher Gent Chairman GlaxoSmithKline plc
2
Registered in England & Wales No. 3888792 Registered office: 980 Great West Road, Brentford Middlesex TW8 9GS
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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Appendix E: 2009 Notice of Annual GlaxoSmithKline Shareholder Meeting
GlaxoSmithKline Notice of Meeting Notice is hereby given that the ninth Annual General Meeting of GlaxoSmithKline plc will be held at the Queen Elizabeth II Conference Centre, Broad Sanctuary, Westminster, London SW1P 3EE on Wednesday, 20th May 2009 at 2.30pm to consider and, if thought fit, pass the following resolutions. All resolutions will be proposed as ordinary resolutions, save for resolutions 12, 13 and 15 which will be proposed as special resolutions. Ordinary Business 1 To receive and adopt the Directors’ Report and the Financial Statements for the year ended 31st December 2008. 2
To approve the Remuneration Report for the year ended 31st December 2008.
3
To elect Mr James Murdoch as a Director.
4
To re-elect Mr Larry Culp as a Director.
5
To re-elect Sir Crispin Davis as a Director.
6
To re-elect Dr Moncef Slaoui as a Director.
7
To re-elect Mr Tom de Swaan as a Director.
8
To authorise the Audit Committee to re-appoint PricewaterhouseCoopers LLP as Auditors to the company to hold office from the end of the Meeting to the end of the next Meeting at which accounts are laid before the company.
9
To authorise the Audit Committee to determine the remuneration of the Auditors.
Special Business 10 Donations to political organisations & political expenditure (Ordinary resolution) THAT, in accordance with section 366 of the Companies Act 2006 (the “2006 Act”) the company is, and all companies that are at any time during the period for which this resolution has effect subsidiaries of the company are, authorised: (a) to make political donations to political organisations other than political parties, as defined in section 363 of the 2006 Act, not exceeding £50,000 in total; and (b) to incur political expenditure, as defined in section 365 of the 2006 Act, not exceeding £50,000 in total, during the period beginning with the date of passing this resolution and ending at the end of the next Annual General Meeting of the company to be held in 2010 or, if earlier, on 30th June 2010. 11 Authority to allot shares (Ordinary resolution) THAT the Directors be and are hereby generally and unconditionally authorised, in substitution for all subsisting authorities, to exercise all powers of the company to allot relevant securities (within the meaning of section 80 of the Companies Act 1985 (the “1985 Act”)): (a) up to an aggregate nominal amount of £432,359,137; and (b) comprising equity securities (as defined in the 1985 Act) up to a nominal amount of £864,692,333 (after deducting from such limit any relevant securities allotted under paragraph (a) above) in connection with an offer by way of a rights issue: 3
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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Appendix E: 2009 Notice of Annual GlaxoSmithKline Shareholder Meeting Notice of Meeting : continued
(i) to ordinary shareholders in proportion (as nearly as may be practicable) to their existing holdings; and (ii) to holders of other equity securities as required by the rights of those securities or as the Board otherwise considers necessary, and so that the Directors may make such exclusions or other arrangements as they consider expedient in relation to fractional entitlements, legal or practical problems under the laws of, or the requirements of any relevant regulatory body or stock exchange in, any territory, or any matter whatsoever, which authorities shall expire at the end of the next Annual General Meeting of the company to be held in 2010 or, if earlier, on 30th June 2010 (unless previously revoked or varied by the company in general meeting) save that under each authority the company may, before such expiry, make an offer or agreement which would or might require relevant securities to be allotted after such expiry and the Directors may allot relevant securities in pursuance of such an offer or agreement as if the relevant authority conferred hereby had not expired. 12 Disapplication of pre-emption rights (Special resolution) THAT the Directors be and are hereby empowered pursuant to section 95 of the 1985 Act to allot equity securities (within the meaning of section 94 of the 1985 Act) for cash pursuant to the authority conferred on the Directors by Resolution 11 and/or where such allotment constitutes an allotment of equity securities by virtue of section 94(3A) of the 1985 Act as if section 89(1) of the 1985 Act did not apply to such allotment, provided that this power shall be limited: (a) to the allotment of equity securities in connection with an offer or issue of equity securities (but in the case of the authority granted under paragraph (b) of Resolution 11, by way of a rights issue only): (i) to ordinary shareholders in proportion (as nearly as may be practicable) to their existing holdings; and (ii) to holders of other equity securities, as required by the rights of those securities or as the Board otherwise considers necessary, but so that the Directors may make such exclusions or other arrangements as they consider expedient in relation to fractional entitlements, legal or practical problems under the laws of, or the requirements of any relevant regulatory body or stock exchange, in any territory, or any matter whatsoever; and (b) in the case of the authority granted under paragraph (a) of Resolution 11, to the allotment (otherwise than pursuant to sub-paragraph (a) above) of equity securities up to an aggregate nominal amount of £64,854,519, and shall expire at the end of the next Annual General Meeting of the company to be held in 2010 or, if earlier, on 30th June 2010, save that the company may before such expiry make an offer or agreement which would or might require equity securities to be allotted after such expiry and the Directors may allot equity securities in pursuance of such an offer or agreement as if the power conferred hereby had not expired. 13 Purchase of own shares by the company (Special resolution) THAT the company be and is hereby generally and unconditionally authorised for the purposes of section 166 of the 1985 Act to make market purchases (within the meaning of section 163 of the 1985 Act) of its own Ordinary shares of 25p each provided that: 4
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(a) the maximum number of Ordinary shares hereby authorised to be purchased is 518,836,153; (b) the minimum price which may be paid for each Ordinary share is 25p; (c) the maximum price which may be paid for each Ordinary share shall be the higher of (i) an amount equal to 105% of the average of the middle market quotations for the company’s Ordinary shares as derived from the London Stock Exchange Daily Official List for the five business days immediately preceding the day on which the Ordinary share is contracted to be purchased and (ii) the higher of the price of the last independent trade and the highest current independent bid on the London Stock Exchange Official List at the time the purchase is carried out; and (d) the authority conferred by this resolution shall, unless renewed prior to such time, expire at the end of the next Annual General Meeting of the company to be held in 2010 or, if earlier, on 30th June 2010 (provided that the company may enter into a contract for the purchase of Ordinary shares before the expiry of this authority which would or might be completed wholly or partly after such expiry). 14 Exemption from statement of the name of the senior statutory auditor in published copies of the Auditors’ reports (Ordinary resolution) THAT: (a) in accordance with section 506 of the 2006 Act, the name of the person who signs the Auditors’ reports to the company’s members on the annual accounts and auditable reports of the company for the year ending 31st December 2009 as senior statutory auditor (as defined in section 504 of the 2006 Act) for and on behalf of the company’s Auditors, should not be stated in published copies of the reports (such publication being as defined in section 505 of the 2006 Act) and the copy of the reports to be delivered to the registrar of companies under Chapter 10 of Part 15 of the 2006 Act; and (b) the company considers on reasonable grounds that statement of the name of the senior statutory auditor would create or be likely to create a serious risk that the senior statutory auditor, or any other person, would be subject to violence or intimidation. 15 Reduced notice of a general meeting other than an annual general meeting (Special resolution) THAT a general meeting of the company other than an Annual General Meeting may be called on not less than 14 clear days’ notice. 16 Approval of the adoption of the GlaxoSmithKline 2009 Performance Share Plan (Ordinary resolution) THAT the adoption of the GlaxoSmithKline 2009 Performance Share Plan (the “PSP”), the principal features of which are summarised in the explanatory notes to this Notice and the rules of which have been signed for the purposes of identification by the Chairman, be and is hereby approved and the Directors are hereby authorised to: (a) do whatever may be necessary or expedient to carry the PSP into effect, including making such modifications to the PSP as they may consider appropriate to take account of the requirements of the UK Listing Authority and best practice; and
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(b) establish further plans for the benefit of employees outside the UK, based on the PSP but modified to take account of local tax, exchange control or securities laws in overseas territories, provided that any shares made available under such plans are treated as counting against the limits on individual and overall participation contained in the PSP. 17 Approval of the adoption of the GlaxoSmithKline 2009 Share Option Plan (Ordinary resolution) THAT the adoption of the GlaxoSmithKline 2009 Share Option Plan (the “SOP”), the principal features of which are summarised in the explanatory notes to this Notice and the rules of which have been signed for the purposes of identification by the Chairman, be and is hereby approved and the Directors are hereby authorised to: (a) do whatever may be necessary or expedient to carry the SOP into effect, including making such modifications to the SOP as they may consider appropriate to take account of the requirements of the UK Listing Authority and best practice; and (b) establish further plans for the benefit of employees outside the UK, based on the SOP but modified to take account of local tax, exchange control or securities laws in overseas territories, provided that any shares made available under such plans are treated as counting against the limits on individual and overall participation contained in the SOP. 18 Approval of the adoption of the GlaxoSmithKline 2009 Deferred Annual Bonus Plan (Ordinary resolution) THAT the adoption of the GlaxoSmithKline 2009 Deferred Annual Bonus Plan (the “DABP”), the principal features of which are summarised in the explanatory notes to this Notice and the rules of which have been signed for the purposes of identification by the Chairman, be and is hereby approved and the Directors are hereby authorised to: (a) do whatever may be necessary or expedient to carry the DABP into effect, including making such modifications to the DABP as they may consider appropriate to take account of the requirements of the UK Listing Authority and best practice; and (b) establish further plans for the benefit of employees outside the UK, based on the DABP but modified to take account of local tax, exchange control or securities laws in overseas territories, provided that any shares made available under such plans are treated as counting against the limits on individual and overall participation contained in the DABP.
By Order of the Board Simon Bicknell Company Secretary 24th March 2009
Registered Office: 980 Great West Road Brentford, Middlesex TW8 9GS Registered in England and Wales No. 3888792
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Notes
(i)
All resolutions at the Meeting will be decided by poll as required by the company’s Articles of Association.
(ii)
A “Vote Withheld” option is provided on the proxy card accompanying this Notice of Meeting which is to enable a member (shareholder) to withhold their vote on any particular resolution. It should be noted that a vote withheld is not a vote in law and will not be counted in the calculation of the proportion of votes “For” or “Against” a resolution.
(iii) A member of the company is entitled to appoint one or more proxies to attend the Meeting, and to speak and vote on his behalf, provided that each proxy is appointed to exercise the rights attached to a different share or shares held by that member. A proxy need not be a member of the company. To appoint a proxy you may: (a) register the appointment of your proxy vote electronically using the internet by going to www.sharevote.co.uk and following the instructions provided. The proxy appointment must be received by the company’s registrars, Equiniti, by 2.30pm on Monday, 18th May 2009. Please note that any electronic communication sent to the company’s registrars in respect of the appointment of a proxy that is found to contain a computer virus will not be accepted; or (b) use the proxy card enclosed with this Notice of Meeting which should be returned direct to Equiniti at the address below, so as to be received no later than 2.30pm on Monday, 18th May 2009; or (c) if you hold your shares in uncertificated form, you should utilise the CREST electronic proxy appointment service by using the procedures described in the CREST Manual. CREST Personal Members or other CREST sponsored members, and those CREST members who have appointed a service provider(s), should refer to their CREST sponsor or voting service provider(s), who will be able to take the appropriate action on their behalf. Further details of voting via CREST are also given on page 23 of this document. If you do not have a proxy card and believe that you should have one, or if you require additional proxy cards, please contact Equiniti on the numbers given below. The return of a completed proxy card, other instrument or any CREST Proxy Instruction (as described in the section entitled “Information on how to vote” below) will not prevent a member attending the Meeting and voting in person if he/she wishes to do so. Equiniti can be contacted by post at: Equiniti Limited FREEPOST SEA 10846 Aspect House Spencer Road Lancing West Sussex BN99 6ZL or by telephone on 0871 384 2991* if calling from within the UK, or on +44 (0)121 415 7067 if calling from outside the UK. *At the time of publication, calls to this number were charged at 8p per minute from a BT landline. The prices charged by BT and other telephony providers may change from time to time. 7
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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(iv) Holders of the company’s American Depositary Shares evidenced by American Depositary Receipts (“ADRs”) may exercise their votes through the Depositary, The Bank of New York Mellon. Such holders wishing to attend the Meeting should obtain prior authority by being nominated an “Appointed Proxy” by the Depositary, who can be contacted at: BNY Mellon Shareowner Services P.O. Box 358516 Pittsburgh, PA 15252-8516 USA Tel: 1 877 353 1154 (US toll free) + 1 212 815 6825 (outside US) (v)
Participants in the company’s Corporate Sponsored Nominee service may exercise their votes through the company’s registrars, Equiniti, by using the form of direction enclosed with this Notice of Meeting, which should be returned direct to Equiniti at the address in Note (iii) above, so as to be received no later than 2.30pm on Saturday, 16th May 2009.
(vi) Any person to whom this Notice is sent who is a person nominated under section 146 of the 2006 Act to enjoy information rights (a “Nominated Person”) may, under an agreement between him/her and the member by whom he/she was nominated, have a right to be appointed (or to have someone else appointed) as a proxy for the Meeting. If a Nominated Person has no such proxy appointment right or does not wish to exercise it, he/she may, under any such agreement, have a right to give instructions to the member as to the exercise of voting rights. (vii) The statement of the rights of members in relation to the appointment of proxies in paragraph (iii) above does not apply to Nominated Persons. The rights described in that paragraph can only be exercised by members of the company. (viii) Copies of contracts of service or, where applicable, letters of appointment, between Directors and the company or any of its subsidiaries are available for inspection at the company’s registered office given above during normal business hours (Saturdays, Sundays and public holidays excepted) and at the place of the Meeting on Wednesday, 20th May 2009 from 1.30pm until the end of the Meeting. (ix) The register of Directors’ interests in the shares of the company and its subsidiaries will also be available for inspection at the place of the Meeting on Wednesday, 20th May 2009 from 1.30pm until the end of the Meeting. (x)
The rules of the proposed GlaxoSmithKline 2009 Performance Share Plan, the GlaxoSmithKline 2009 Share Option Plan and the GlaxoSmithKline 2009 Deferred Annual Bonus Plan will be available for inspection at the company’s registered office given above and at One Bunhill Row, London, EC1Y 8YY during normal business hours (Saturdays, Sundays and public holidays excepted) from the date of this Notice until the conclusion of the Meeting and at the place of the Meeting on Wednesday, 20th May 2009 from 1.30pm until the end of the Meeting.
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(xi) Members must be entered on the company’s register of members on Monday, 18th May 2009, at 6.00pm (or, in the event of an adjournment, 6.00pm on the date which is two days before the time of the adjourned meeting), to be entitled to attend and vote at the Meeting. Members may cast votes only in respect of shares of which they were registered holders at such time, and changes to the register of members after the relevant deadline shall be disregarded in determining the rights of any person to attend and vote at the Meeting. (xii) To facilitate voting by corporate representatives at the Meeting, arrangements will be put in place at the Meeting so that: (a) if a corporate member has appointed the Chairman of the Meeting as its corporate representative with instructions to vote on a poll in accordance with the directions of all the other corporate representatives for that member at the Meeting, then on a poll those corporate representatives will give voting directions to the Chairman and the Chairman will vote (or withhold a vote) as corporate representative in accordance with those directions; and (b) if more than one corporate representative for the same corporate member attends the Meeting but the corporate member has not appointed the Chairman of the Meeting as its corporate representative, a designated corporate representative will be nominated from those corporate representatives who attend, who will vote on a poll and the other corporate representatives will give voting directions to that designated corporate representative. Corporate members are referred to the guidance issued by the Institute of Chartered Secretaries and Administrators on proxies and corporate representatives (www.icsa.org.uk) for further details of this procedure. The guidance includes a sample form of representation letter if the Chairman is being appointed as described in (a) above.
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GlaxoSmithKline Explanatory Notes to Business of the Annual General Meeting Ordinary Business Each resolution will be proposed as an ordinary resolution. This means that for each of the resolutions to be passed, more than half of the votes cast must be in favour of the resolution. Resolution 1 – To receive and adopt the Directors’ Report and the Financial Statements for 2008 For each financial year, the Directors must present the Directors’ Report, the audited Financial Statements and the independent Auditors’ reports to shareholders at a General Meeting. Resolution 2 – To approve the 2008 Remuneration Report In accordance with the Directors’ Remuneration Report Regulations 2002, shareholders are invited to vote on the Remuneration Report, which may be found on pages 78 to 98 of the 2008 Annual Report. Resolutions 3-7 – Election and Re-election of Directors The company’s Articles of Association require any Director newly appointed by the Board to retire at the first Annual General Meeting (“AGM”) after appointment. You are therefore asked to elect as a Director, Mr James Murdoch, who has been appointed by the Board since last year’s AGM. The Board considers that his experience of global business, marketing and communications will bring a unique and alternative perspective to the Board and he will also be an excellent addition to the Board’s Corporate Responsibility Committee, an area where he has shown particular leadership at BSkyB and News Corporation. The Board has determined that he will be an independent Non-Executive Director in accordance with the Combined Code on Corporate Governance. The Articles of Association also require certain of the current Directors to retire at each AGM dependent on their length of service and the period since their last re-election. All of the Directors are eligible to seek re-election by shareholders at the AGM, if they so wish. Mr Larry Culp, Sir Crispin Davis, Sir Ian Prosser, Dr Ronaldo Schmitz, Dr Moncef Slaoui and Mr Tom de Swaan are all retiring by rotation. Neither Sir Ian nor Dr Schmitz will seek re-election and will retire from the Board at the conclusion of the AGM. Mr Culp and Sir Crispin were elected to the Board in 2004. Dr Slaoui and Mr de Swaan were elected to the Board in 2006. Mr Culp, Sir Crispin, Dr Slaoui and Mr de Swaan each offer themselves for re-election at the AGM. The Chairman is satisfied that each of them continues to perform effectively and demonstrates commitment to their role including commitment of time for Board and committee meetings and their other duties. Mr Culp, Sir Crispin, and Mr de Swaan are all Non-Executive Directors and have letters of appointment rather than service contracts. Dr Slaoui has a service contract with a notice period of 12 months. The Non-Executive Directors’ letters of appointment and Executive Directors’ service contracts are available for inspection as specified in Note (viii) above. Biographical details for each of the Directors standing for election or re-election to the Board at the Meeting are given in the company’s 2008 Annual Report. In addition, current biographical details for each Director are maintained on www.gsk.com.
Resolutions 8 and 9 – To authorise the Audit Committee to re-appoint PricewaterhouseCoopers LLP as Auditors to the company and to determine their remuneration At every General Meeting at which accounts are presented to shareholders, the 10
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company is required to appoint auditors to serve until the next such meeting. PricewaterhouseCoopers LLP have indicated that they are willing to continue as the company’s Auditors for another year. You are asked to re-appoint them and, following normal practice, to authorise the Audit Committee to determine their remuneration. Details of the company’s policy with regard to non-audit work and details of work undertaken by the Auditors and their remuneration are given in the company’s Annual Report which can be viewed on www.gsk.com.
Special Business Where resolutions are passed as special resolutions, in order for those resolutions to be passed at least three-quarters of the votes cast must be in favour of the resolution. Resolution 10 – Donations to political organisations & political expenditure (Ordinary resolution) The 2006 Act requires companies to obtain shareholder approval before they can make donations to EU political organisations or incur EU political expenditure. However, the company does not make and does not intend to make donations to political parties or independent election candidates, nor does it make any donations to EU political organisations or incur EU political expenditure. The definitions of political donations, political expenditure and political organisations used in the 2006 Act are very wide. In particular, the definition of political organisations may extend to bodies such as those concerned with policy review, law reform, the representation of the business community and special interest groups such as those concerned with the environment, which the company and its subsidiaries might wish to support. As a result, the definitions may cover legitimate business activities not in the ordinary sense considered to be political donations or political expenditure. Such activities are not designed to support any political party or independent election candidate or to influence public support for any political party or independent election candidate. The authority which the Board is requesting is a precautionary measure to ensure that the company and its subsidiaries do not inadvertently breach the 2006 Act. No payments have ever been made under this authority, which is specific to political donations and political expenditure in relation to any and all EU member states. In addition, with effect from 1st January 2009, to ensure a consistent approach to political contributions across the GSK group, the company introduced a global policy to voluntarily stop all political contributions. In the past, GSK, in common with many companies and in full compliance with local laws, has made a number of political contributions in countries outside the EU, such as the US and Canada. Further details of the payments made in 2008 can be found in the 2008 Annual Report.
Resolution 11 – Authority to allot shares (Ordinary resolution) Paragraph (a) of this resolution gives the Directors authority to allot unissued share capital with a nominal value of up to £432,359,137 (representing 1,729,436,548 Ordinary shares of 25 pence each) which, as at 24th February 2009, being the last practicable date prior to the publication of this Notice, represented just less than onethird of the issued share capital of the company (excluding treasury shares). In line with recent guidance issued by the Association of British Insurers, paragraph (b) of this resolution gives the Directors authority to allot Ordinary shares in connection with a rights issue in favour of ordinary shareholders with a nominal value of up to £864,692,333 (representing 3,458,769,332 Ordinary shares of 25 pence each), as reduced by the nominal amount of any shares issued under paragraph (a) of this resolution. This amount (before any reduction) represents just less than two-thirds of the issued ordinary share capital of the company (excluding treasury shares) as at 24th February 2009, being the last practicable date prior to publication of this Notice. 11
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The authorities sought under paragraphs (a) and (b) of this resolution will expire at the earlier of 30th June 2010 (being the last date by which the company must hold an AGM in 2010) or the conclusion of the AGM of the company held in 2010. The Directors have no present intention to exercise either of the authorities sought under this resolution, except, under paragraph (a), to fulfil the company’s obligations under its executive and employee share plans.
Resolution 12 – Disapplication of pre-emption rights (Special resolution) This resolution gives the Directors authority to allot Ordinary shares (including any Ordinary shares which the company has purchased and elected to hold as treasury shares) for cash without first offering them to existing shareholders in proportion to their existing shareholdings and is limited to allotments in connection with rights issues or other pre-emptive offers, or otherwise up to a maximum nominal amount of £64,854,519 (representing 259,418,076 Ordinary shares of 25 pence each) which, as at 24th February 2009, being the last practicable date prior to the publication of this Notice, represented just less than 5% of the company’s issued share capital (excluding treasury shares). In respect of this aggregate nominal amount, the Directors confirm their intention to follow the provisions of the Pre-Emption Group’s Statement of Principles regarding cumulative usage of authorities within a rolling three-year period where the Principles provide that usage in excess of 7.5% should not take place without prior consultation with shareholders. This authority will expire at the earlier of 30th June 2010 or the conclusion of the AGM of the company in 2010. This authority is granted under section 95 of the 1985 Act and is a standard annual resolution for most UK companies listed on the London Stock Exchange.
Resolution 13 – Purchase of own shares by the company (Special resolution) This resolution seeks authority for the company to make market purchases of its own Ordinary shares. Purchases of the company’s own shares will be made only after considering the effects on earnings per share and the benefits for shareholders generally. The company does not expect to make any significant repurchases in 2009. You are asked to consent to the purchase by the company of up to a maximum of 518,836,153 Ordinary shares, which, as at 24th February 2009 being the last practicable date prior to the publication of this Notice, represented just less than 10% of the company’s issued share capital (excluding treasury shares). This authority will expire at the end of the next AGM or, if earlier, on 30th June 2010. The maximum price which may be paid for an Ordinary share will be the higher of (i) 105% of the average middle market quotations for the five business days preceding the purchase and (ii) the higher of the price of the last independent trade and the highest current independent bid at the time the purchase is carried out. The minimum price which may be paid for an Ordinary share is its nominal value of 25p. The company may either retain any of its own shares which it has purchased as treasury shares with a view to possible re-issue at a future date, or cancel them. The company would consider holding any of its own shares that it purchases pursuant to the authority conferred by this resolution as treasury shares. This would give the company the ability to re-issue treasury shares quickly and cost-effectively, and would provide the company with additional flexibility in the management of its capital base. The total number of options over Ordinary shares outstanding as at 24th February 2009, being the last practicable date prior to the publication of this Notice, was approximately 319 million representing approximately 6.15% of the issued share capital (excluding treasury shares). If the authority to buy back shares under this resolution were exercised in full, the total number of options to subscribe for Ordinary shares outstanding as at 24th February 12
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2009 would, assuming no further Ordinary shares are issued, represent 6.83% of the issued share capital (excluding treasury shares). The total number of options as set out above includes options granted by the company and legacy companies, Glaxo Wellcome plc and SmithKline Beecham plc. The obligations of the company in respect of Ordinary shares issuable under options outstanding are partly hedged by Ordinary shares held by the Group’s employee share ownership trusts, details of which can be found in the 2008 Annual Report which is available on the company’s website at www.gsk.com. The company’s current intention is to satisfy the exercise of outstanding options over approximately 90 million Ordinary shares, representing approximately 1.74% of the issued share capital of the company (excluding treasury shares), by the release of Ordinary shares from the Group’s employee share ownership trusts, which on 24th February 2009 held approximately 157 million Ordinary shares, and the remainder by the issue of new Ordinary shares.
Resolution 14 – Exemption from statement of the name of the senior statutory auditor in published copies of the Auditors’ reports (Ordinary resolution) For financial years beginning on or after 6th April 2008, every copy of the Auditors’ reports to the company’s shareholders on the Annual Report and other auditable reports that is or are published by or on behalf of the company must state, where the company’s Auditors are a firm, the name of the person who signed them in his or her own name as senior statutory auditor in relation to the audit, for and on behalf of the Auditors. However, the 2006 Act provides an exemption from this requirement if the company considers on reasonable grounds that statement of the individual’s name would create or be likely to create a serious risk that they or any other person would be subject to violence or intimidation. For many years, the company and its legacy companies, together with its employees, have been the focus of protests by various animal protection groups, some of which have engaged in aggressive, abusive and hostile acts. The Directors therefore believe that it is appropriate that the company should seek to utilise the confidentiality afforded to the senior statutory auditor of the company’s Auditors under the new legislation. This resolution therefore seeks shareholder approval for the Auditors’ reports for the financial year ending 31st December 2009 to omit the name of the senior statutory auditor. The company would give notice to the Secretary of State in the appropriate format if this resolution is passed. Resolution 15 – Reduced notice of a general meeting other than an annual general meeting (Special resolution) This resolution seeks shareholder approval to continue to be able to call general meetings other than AGMs on not less than 14 days’ notice as currently permitted under the 2006 Act. The UK Government is proposing to bring into force on 3rd August 2009 regulations to implement the EU Shareholder Rights Directive (the “Directive”) on the exercise of certain rights of shareholders in listed companies. The regulations implementing the Directive will require that listed companies provide 21 days’ notice of a general meeting. However, the UK Government will be taking advantage of an option within the Directive, which will allow companies to retain a 14 clear days’ notice period for calling a general meeting (other than an AGM, which must continue to be called on notice of at least 21 clear days) if two conditions are met. These are (a) that shareholders have, at the immediately preceding AGM or at a general meeting held since the immediately preceding AGM, passed a resolution to approve the holding of general meetings on not less than 14 clear days’ notice; and (b) that the company offers the facility for shareholders to vote by electronic means accessible to all shareholders. 13
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The Government has indicated that companies can pass the type of resolution referred to at (a) above in advance of the regulations being finalised, in order to be able to continue, after August 2009, to take advantage of the shorter notice period once the regulations come into force, subject to meeting the requirements for electronic voting under the Directive. The Government has recommended that companies seeking to propose this resolution in advance of the regulations being finalised should consider doing so as a special resolution. If approved, Resolution 15 will enable the company to retain maximum flexibility to seek shareholder approval for any future change or transaction that may require such approval. The approval will be effective until the company’s next AGM, when it is intended that a similar resolution will be proposed.
Resolutions 16, 17 and 18 – Approval of the adoption of the GlaxoSmithKline 2009 Performance Share Plan, the GlaxoSmithKline 2009 Share Option Plan and the GlaxoSmithKline 2009 Deferred Annual Bonus Plan (Ordinary resolutions) Shareholders are asked to approve the adoption of the rules of the GlaxoSmithKline 2009 Performance Share Plan, the GlaxoSmithKline 2009 Share Option Plan and the GlaxoSmithKline 2009 Deferred Annual Bonus Plan, (together, the “Plans”) to replace the company’s existing plans which expire in 2010. These plans have been designed to deliver the new Remuneration Policy which is set out in the company’s Annual Report. The principal terms of the Plans are set out on the next pages. 1
Common features The following features are common to the Plans.
1.1 Operation The company’s Remuneration Committee is responsible for granting awards to and operating the Plans with regard to Executive Directors and Corporate Executive Team members (together, the “Executives”). The Board, or a duly authorised committee of the Board (which may be the Remuneration Committee), is responsible for granting awards to and operating the Plans with regard to all other employees. 1.2 Eligibility Employees and Executive Directors of the company and any subsidiaries of the company (as designated by the Directors) are eligible to participate in the Plans. 1.3 Timing of operation Awards will normally be granted under the Plans within 42 days of the announcement of the company’s results for any period but may be granted at other times if the Remuneration Committee considers the circumstances to be exceptional. However, at all times the grant of awards will be subject to the terms of the Model Code for transactions in securities by Directors and the company’s share dealing code. Subject to shareholder approval, the first awards under the GlaxoSmithKline 2009 Performance Share Plan are expected to be granted shortly after the adoption of the Plans at the AGM. 1.4 Grant of awards Awards may be satisfied with newly issued shares, treasury shares or shares purchased in the market in conjunction with an employee benefit trust established by the company. At the discretion of the Remuneration Committee, awards may be granted subject to the participant agreeing to satisfy the employer’s social security liabilities arising on the award.
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1.5 Dilution limits In any 10 year period, not more than 10% of the issued ordinary share capital of the company may be issued or issuable under the Plans and all other employee share plans adopted by the company. In addition, in any 10 year period, not more than 5% of the issued ordinary share capital of the company may be issued or issuable under the Plans and all other discretionary employee share plans adopted by the company. These limits do not include awards and options which have lapsed or been surrendered. So long as this is required under the guidelines of the Association of British Insurers’ Investment Committee, the company will include in this calculation any treasury shares used to satisfy awards and options granted under the Plans. 1.6 Variation in share capital Awards may be adjusted at the discretion of the Remuneration Committee following any rights issue, special dividend, de-merger, consolidation, sub-division, reduction or other variation in the share capital of the company. 1.7 Issue of shares Any shares issued under the Plans will rank equally with shares of the same class in issue on the date of allotment except in respect of rights arising by reference to a prior record date. 1.8 Amendments The Remuneration Committee may amend the Plans as it considers appropriate. However, shareholder approval will be required to amend certain provisions to the advantage of participants. These provisions relate to: eligibility, individual and plan limits, adjustment of awards on a variation in the company’s share capital and the amendment powers. Shareholder approval is not required for changes that are minor in nature or for changes intended to benefit the administration of the Plans, or to comply with or take account of existing or proposed legislation or any changes in legislation or to secure favourable tax treatment for the company, members of its group or participants. 1.9 Other features Awards granted under the Plans are not pensionable and are not generally transferable (except in the case of death). 1.10 Termination The Plans may be terminated by the Remuneration Committee at any time. Awards may not be granted after the tenth anniversary of the approval of the Plans by shareholders. 1.11 Forfeiture The Remuneration Committee may reduce grant levels or outstanding awards or options granted under the Plans that have not yet vested or been exercised (with the exception of Invested Shares granted under the Deferred Annual Bonus Plan), if it is determined that a participant has engaged in conduct which is contrary to the legitimate expectations of the company for an employee in the participant’s position.
15
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2
GlaxoSmithKline 2009 Performance Share Plan
2.1 Outline The Remuneration Committee may grant conditional share awards or nil-cost options to selected eligible employees (“Awards”). 2.2 Individual limits The aggregate value (at the time of the grant) of shares subject to all Awards granted to a participant under this plan in any year will not exceed 6 times the participant’s base salary, except in exceptional circumstances. The value of the Awards to be granted to the Chief Executive Officer in 2009 will be 5 times his base salary. In applying the plan limit, no account will be taken of shares representing notional dividends on Awards or shares which have been awarded to ensure that a participant is not financially disadvantaged if he or she agrees to satisfy the employer’s social security liability in relation to his or her Award. 2.3 Performance condition The Remuneration Committee will set performance conditions annually, which must normally be satisfied before an Award can vest. For Executives, the performance conditions will normally be measured over a period of at least three financial years. The Remuneration Committee may change a performance condition if there is a situation which causes it to consider that the changed performance condition would be a fairer measure of performance. The performance conditions for Awards granted to Executives in 2009 will be based on relative Total Shareholder Return (“TSR”) over three financial years as to 30% of the Award, TSR over four financial years as to 30% of the Award and free cash flow targets as to 40% of the Award over three financial years. The performance period for Awards granted in 2009 will begin on 1st January 2009. For the Awards made in 2009, TSR performance will be measured by comparing the TSR achieved by the company with that of a comparator group currently comprising the following 12 global pharmaceutical companies: Abbott Laboratories, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Merck, Novartis, Pfizer, Roche Holdings, Sanofi-Aventis, Schering-Plough and Wyeth. Awards will not vest if the company’s TSR performance is below median. If the company’s TSR performance is median, 30% of the Award will vest, with full vesting for upper quartile performance. Between these levels, Awards will vest proportionally. If the free cash flow threshold is met, 25% of the Award will vest, with full vesting if the threshold is exceeded by the margin specified by the Remuneration Committee. Between these points, vesting will increase on a pro rata basis. If the threshold target is not met, no portion of the Award subject to free cash flow will vest. The free cash flow targets may be adjusted for material factors, which could distort free cash flow as a performance measure. These will typically include exchange rate movements and may include legal and major taxation settlements and special pension contributions, which could materially distort this calculation in either direction. The impact of any acquisition or divestment will be quantified and adjusted for at the time of the event. It is the Remuneration Committee’s intention to disclose the targets for each Award in the announcement to the London Stock Exchange at the time the Award is made. For the Awards in 2009, the threshold free cash flow target will be £13.5 billion, with maximum vesting for £16 billion.
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2.4 Acquisition of shares A participant will normally only acquire the shares subject to Awards to the extent that the performance conditions have been satisfied and provided that the participant remains in employment. When shares are acquired, the participant may also receive additional shares (or an equal cash amount) which reflect reinvested dividends that would have been paid on the vested portion of the Award during the performance period. 2.5 Leaving employment If an Executive leaves employment due to retirement or redundancy, Awards will normally vest on the original vesting date, subject to the satisfaction of the performance condition over the original period. Any Awards granted within 12 months of cessation will lapse on the date of cessation. The Committee may determine that any unvested Awards should lapse immediately, if the participant takes up employment with a competitor company during the performance period. Alternatively, the Remuneration Committee may decide that on retirement or redundancy, Executives’ Awards will vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking account of performance to that point. In this case, the Committee may also adjust the number of shares which may be acquired to take account of the time the Executive was employed during the performance period. If an Executive leaves employment due to death, ill-health, injury or disability, or the sale or transfer of the participant’s employing business, Awards will vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking into account performance to that time. The Committee may also adjust the number of shares which may be acquired to take account of the time the Executive was employed during the performance period. Awards held by participants other than Executives who leave due to retirement or redundancy will normally vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking into account performance to that time. The Committee may also adjust the number of shares which may be acquired to take account of the time the participant was employed during the performance period. Awards held by participants other than Executives who leave due to death, ill-health, injury or disability, or the sale or transfer of the participant’s employing business will vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking into account performance to that time. The Committee may also adjust the number of shares which may be acquired to take account of the time the participant was employed during the performance period. If any participant (Executive or otherwise) leaves employment for any other reason, Awards will normally lapse. 2.6 Change of control, de-merger or other reorganisations Generally, Awards will vest on a change of control taking into account performance to that point. Unless the Remuneration Committee decides otherwise, the number of shares which may be acquired will also be reduced to take account of the time the participant was employed during the performance period.
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The Remuneration Committee has the discretion to allow or require rollover of Awards on a change of control or other corporate reorganisation. The new Awards will be subject to appropriate performance conditions. On a de-merger, if the Remuneration Committee so decides, Awards may be adjusted or allowed to vest. 3
GlaxoSmithKline 2009 Share Option Plan
3.1 Outline Selected eligible employees may be granted market value options (“Options”) over the company’s shares or equity-settled Stock Appreciation Rights. The Option price will not be less than the market value of a share on the business day before the date of grant or the average market value over the three preceding business days. 3.2 Individual limits Where a participant receives Options under the company’s 2009 Share Option Plan and Awards under the company’s 2009 Performance Share Plan in any year, it is currently intended that the expected value of Options granted to him or her in that year will not exceed 60% of the aggregate expected value of Options and Performance Share Plan Awards granted to him or her in that year. In applying this limit, no account will be taken of shares which have been awarded to ensure that a participant is not financially disadvantaged if he or she agrees to satisfy the employer’s social security liability in relation to the Options. Where a participant is not granted Awards under the company’s 2009 Performance Share Plan, the annual Share Option Plan limit will be calculated on an equivalent basis to that which applies to the company’s 2009 Performance Share Plan. It is the current intention that Options will not be granted to the Chief Executive Officer or Chief Financial Officer. 3.3 Performance condition The Remuneration Committee may, and for Executives will, set a performance condition annually, and any such performance condition imposed must normally be satisfied before the exercise of an Option. The performance condition will normally be measured over a period of at least three financial years. In line with previous option grants, the performance condition for any Options granted to Executives in 2009 is based on the company’s Earnings Per Share (“EPS”) relative to the Retail Prices Index (“RPI”). Options will not vest if compound EPS growth is less than RPI plus 3% per annum. If compound EPS growth is RPI plus 3% per annum Options will vest as to 30%, if it is RPI plus 4%, they will vest as to 65% and if it is RPI plus 5%, they will vest as to 85%. Full vesting will occur if compound EPS growth is at least RPI plus 6% per annum. In between these levels, Options will vest on a pro rata basis. The performance period for Options granted in 2009 to Executives will begin on 1st January 2009 and will be three financial years in respect of 50% of the award and four financial years in respect of the remaining 50% of the award. 3.4 Exercise of Options Options will normally vest (become exercisable) no less than three years following the date of grant, subject to any performance condition being satisfied and to the participant remaining in employment. In respect of the Options granted to Executives in 2009, subject to performance and remaining in employment, 50% of the Options will vest following the determination of the satisfaction of the performance condition over three financial years by the 18
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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Remuneration Committee and the remaining 50% following the determination of the performance condition over four financial years. Options will normally lapse on the tenth anniversary of the grant date. 3.5 Leaving employment If an Executive leaves employment due to retirement or redundancy, Options will normally vest on the original vesting date, subject to the satisfaction of the performance condition over the original period. The Remuneration Committee may determine that any Options granted within 12 months of cessation will lapse on the date of cessation. The Committee may also determine that unvested Options will lapse immediately if the participant takes up employment with a competitor company prior to vesting. Alternatively, the Remuneration Committee may decide on retirement or redundancy, that Options for Executives will vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking into account performance to that point. If an Executive leaves employment due to death, ill-health, injury, disability or due to a sale or transfer of the participant’s employing business, Options will vest at the end of the financial year in which the cessation occurred or at another point that the Remuneration Committee decides at its discretion, normally taking into account performance to that point. Options held by participants other than Executives who leave for any of the reasons described above will normally vest at the end of the financial year in which the cessation occurred or at such earlier point that the Remuneration Committee decides at its discretion. In all leaver circumstances described above, vested Options may be exercised up to the later of 48 months from grant, 24 months from the cessation of employment and six months from the normal vesting date (apart from on death, in which case they will be exercisable for 12 months from the date of death). If not exercised within the specified period, the Options will lapse. If any participant (Executive or otherwise) leaves employment for any other reason, unvested Options will normally lapse. 3.6 Change of control, de-merger or other reorganisations Generally, Options will vest on a change of control taking into account performance to that point, and the level of vesting may be adjusted if the Remuneration Committee considers it appropriate. Vested Options may be exercised for six weeks and if not exercised within this period, the Options will lapse. The Remuneration Committee has the discretion to allow or require rollover of Options on a change of control or other corporate reorganisation. The new Options will be subject to equivalent performance conditions, if any. On a de-merger, if the Remuneration Committee so decides, Options may be adjusted or allowed to vest. 4 GlaxoSmithKline 2009 Deferred Annual Bonus Plan 4.1 Outline Selected eligible employees may be invited to invest an element of their pre-tax or net annual bonus in the company’s shares (“Invested Shares”). Participants will then be granted an award of matching shares (“Matching Shares”). Such awards may take the form of a conditional share award or a nil-cost option (or other forms with 19
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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an economically equivalent value). The receipt of Matching Shares is normally subject to the satisfaction of a performance condition, continued employment and the continued holding of the Invested Shares until the point when the Matching Shares vest. Executives who did not receive option grants in 2009 will be invited to invest up to 50% of their pre-tax or net annual bonus in the plan. 4.2 Individual limits Matching Shares will be calculated on the basis of a maximum of one share for each share invested by the participant (determined on a pre-tax basis). 4.3 Performance condition The Remuneration Committee will set a performance condition for the Matching Shares which must normally be satisfied before Matching Shares can vest. The performance condition will be measured over a period of at least three financial years. The performance condition for Matching Shares granted in respect of the 2009 bonus will be based on TSR, and will be the same as the TSR performance condition for PSP Awards, as described on page 16 above. The TSR performance condition for all Matching Shares will be measured over three financial years. 4.4 Acquisition of shares A participant will only acquire the Matching Shares if they vest, to the extent that the performance condition has been satisfied and provided that the participant remains in employment for that period. On release, the participant will also receive shares or a cash amount with a value equal to reinvested dividends that would have been paid on those shares during the performance period. Invested Shares will be released at the end of the performance period. 4.5 Leaving employment Invested Shares will be released when a participant is no longer eligible to receive Matching Shares in respect of those Invested Shares, whatever the reason. Matching Shares held by leavers will be treated as described on page 17 in relation to Awards granted under the company’s 2009 Performance Share Plan. 4.6 Change of control, de-merger or other reorganisations Invested Shares will be released on a change of control unless Matching Shares are exchanged as described below. Generally, Matching Shares will vest on a change of control taking into account performance to that point. Unless the Remuneration Committee decides otherwise, the number of shares which may be acquired will also be reduced to take account of the time the Executive was employed during the performance period. The Remuneration Committee has the discretion to allow or require rollover of Matching Shares on a change of control or other corporate reorganisation. The new Matching Shares will be subject to equivalent performance conditions, if any. On a de-merger, if the Remuneration Committee so decides, Matching Shares may be adjusted or allowed to vest. In this case, Invested Shares will not be released but will be exchanged for shares in the acquiring company.
20
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Issued share capital All references to the company’s ‘issued share capital’ in the Explanatory Notes above are to the company’s issued share capital as at 24th February 2009, which was 5,188,361,535 Ordinary shares, excluding any Ordinary shares held as treasury shares. As at 24th February 2009, the company held 474,194,158 Ordinary shares as treasury shares, representing 9.14% of the company’s issued share capital (excluding treasury shares) as at that date. As at 24th February 2009, the total number of voting rights in the company was 5,188,361,535. The following information is provided in respect of section 992 Companies Act 2006: Share capital and control As at 31st December 2008, the company’s authorised share capital comprised £2,500,000,000, divided into 10,000,000,000 Ordinary shares of 25p each nominal value, representing 100% of the total authorised share capital. On 31st December 2008 there were 5,187,122,079 Ordinary shares in issue, excluding 474,194,158 treasury shares (which represented 9.14% of the total issued capital). GSK’s shares are listed on the London Stock Exchange and are also quoted on the New York Stock Exchange in the form of American Depositary shares (“ADSs”). Each ADS represents two Ordinary shares. The holders of Ordinary shares are entitled to receive dividends, when declared, the company’s report and accounts, to attend and speak at General Meetings of the company, to appoint proxies and to exercise voting rights. There are no restrictions on transfer, or limitations on the holding of Ordinary shares and no requirements to obtain prior approval to any transfers. No Ordinary shares carry any special rights with regard to control of the company and there are no restrictions on voting rights. Major shareholders have the same voting rights per share as all other shareholders. There are no known arrangements under which financial rights are held by a person other than the holder of the shares and no known agreements or restrictions on share transfers or on voting rights. Shares acquired through GSK share schemes and plans rank equally with the other shares in issue and have no special rights. The trustees of the company’s Employee Share Ownership Plan (“ESOP”) trusts have waived their rights to dividends on shares held by the ESOP trusts.
Change of control The company is not party to any significant agreements that would take effect, alter or terminate upon a change of control following a takeover bid. The company does not have agreements with any Director or Officer that would provide compensation for loss of office or employment resulting from a takeover, except that provisions of the company’s share plans may cause options and awards granted under such plans to vest on a takeover.
Interests in voting rights Other than as stated below, as far as the company is aware, there are no persons with significant direct or indirect holdings in the company. Information provided to the company pursuant to the Financial Services Authority’s (“FSA”) Disclosure and Transparency Rules (“DTRs”) is published on a Regulatory Information Service and on the company’s website.
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At 24th February 2009, the company had received notifications in accordance with the FSA’s DTRs of the following notifiable interests, in the voting rights in the company’s issued share capital: No. of Percentage of issued shares capital (%)* Barclays PLC 186,518,653 3.59 * Percentage of Ordinary shares in issue, excluding treasury shares as at 24th February 2009.
The Bank of New York Mellon is the Depositary for the company’s ADRs, which are listed on the New York Stock Exchange. Ordinary shares representing the company’s ADR program, which are managed by the Depositary, are registered in the name of BNY (Nominees) Limited. The company has not acquired or disposed of any interests in its own shares, other than in connection with the company’s share buy-back programme. Details of the shares purchased, cancelled and held in treasury are given in the Annual Report.
Directors and Officers The interests of Directors and Officers and their connected persons in the issued share capital of the company are given in the Annual Report. The rules about the appointment and replacement of Directors are contained in the company’s Articles of Association. The company’s Articles must be approved by shareholders in accordance with the legislation in force from time to time. The Articles provide that Directors may be appointed by an ordinary resolution of the members or by a resolution of the Directors, provided that, in the latter instance, a Director appointed in this way retires at the first AGM following his appointment. The Articles also require that at every AGM certain of our current Directors retire by rotation, and detail the circumstances in which and how they may be re-elected. The company’s members may remove a Director by passing an ordinary resolution of which special notice has been given. A Director will automatically cease to be a Director if (i) he becomes bankrupt or compounds with his creditors generally, (ii) he is or has been suffering from mental ill health and the Board resolves that his office is vacated, (iii) he has missed Directors’ meetings for a continuous period of six months without permission and the Board resolves that he shall cease to be a Director, (iv) he is prohibited from being a Director by law, (v) he ceases to be a Director by virtue of UK companies legislation or is removed from office pursuant to the company’s Articles of Association, (vi) he resigns, (vii) he offers to resign and the Board accepts that offer, or (viii) his resignation is requested by all of the other Directors and all of the other Directors are not less than three in number. The company’s Articles may be amended by a special resolution of the members. The powers of the Directors are determined by UK legislation and the company’s Memorandum and Articles of Association, available on www.gsk.com. As provided in those Articles, the Directors may exercise all the company’s powers provided that the Articles or applicable legislation do not stipulate that any such powers must be exercised by the members. The Directors have been authorised to issue and allot Ordinary shares, and have authority to make market purchases of shares. Renewal of these authorities is sought from shareholders at each AGM. Any shares purchased may be cancelled or held as treasury shares.
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GlaxoSmithKline Information on how to vote Voting using Shareview If you have a Shareview portfolio, you may register your vote electronically by visiting www.shareview.co.uk, logging into your account and following the instructions provided. Voting using Sharevote You may register your vote electronically by visiting www.sharevote.co.uk and following the instructions provided. Voting using CREST’s electronic proxy appointment service If you hold your shares in uncertificated form in CREST you may use the electronic proxy appointment service operated by CREST to appoint a proxy and register your vote. CREST members who wish to appoint a proxy or proxies by utilising the CREST electronic proxy appointment service may do so for the AGM to be held on Wednesday, 20th May 2009 and any adjournment(s) thereof by utilising the procedures described in the CREST Manual. CREST Personal Members or other CREST sponsored members, and those CREST members who have appointed a voting service provider(s), should refer to their CREST sponsor or voting service provider(s), who will be able to take the appropriate action on their behalf. In order for a proxy appointment or instruction made using the CREST service to be valid, the appropriate CREST message (a “CREST Proxy Instruction”) must be properly authenticated in accordance with Euroclear’s specifications and must contain the information required for such instructions, as described in the CREST Manual. The message, regardless of whether it constitutes the appointment of a proxy or an instruction to a previously appointed proxy, must be transmitted so as to be received by the issuer’s agent, Equiniti ID RA19 by 2.30pm on Monday, 18th May 2009 in order to be valid. For this purpose, the time of receipt will be taken to be the time (as determined by the timestamp applied to the message by the CREST Applications Host) from which the issuer’s agent is able to retrieve the message by enquiry to CREST in the manner prescribed by CREST. After this time any change of instructions to proxies appointed through CREST should be communicated to the appointee through other means. CREST members and, where applicable, their CREST sponsors or voting service providers should note that Euroclear does not make available special procedures in CREST for any particular messages. Normal system timings and limitations will therefore apply in relation to the input of CREST Proxy Instructions. It is the responsibility of the CREST member concerned to take (or, if the CREST member is a CREST Personal Member or sponsored member or has appointed (a) voting service provider(s), to procure that his CREST sponsor or voting service provider(s) take(s)) such action as shall be necessary to ensure that a message is transmitted by means of the CREST system by any particular time. In this connection, CREST members and, where applicable, their CREST sponsors or voting service providers are referred, in particular, to those sections of the CREST Manual concerning practical limitations of the CREST system and timings. The company may treat as invalid a CREST Proxy Instruction in the circumstances set out in Regulation 35(5)(a) of the Uncertificated Securities Regulations 2001.
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GlaxoSmithKline plc 980 Great West Road Brentford Middlesex TW8 9GS
Source: Retrieved October 25, 2009, from www.gsk.com/investors/agm/2009/agm-notice-2009.pdf
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Appendix F: Access to Medicine Index Report
GlaxoSmithKline
Company Profile
Ticker: GSKLN
2007 Revenues:
GlaxoSmithKline
UK
USD 44,640 million 32% of revenues are generated in Europe, 45% in the US and 23% in the rest of the world. TB: In collaboration with TB Alliance: Bacterial Topoisomerase (lead optimized), Pleuromutilins (lead optimized), inhA Inhibitors (lead identified), antimicrobial screening program (discovery). In collaboration with Aeras Global TB vaccine Foundation: vaccine (Mtb72F/AS02A) in phase 1.
Product Pipeline For Neglected Diseases
Malaria: In collaboration with MMV: 1. n-tert butyl isoquine GSK 369796 (preclinical) 2. 4(1H) pyridones back-ups (Preclinical) 3. Falcipains (Cysteine Protease) (lead optimized) 4. Fatty Avid Bionsynthesis (lead optimized) In collaboration with W Reed: Tafenoquine/etaquine (phase 3) The company itself: Antimicrobial Screening Program (discovery) + Vaccine with the Malaria Vaccine Initiative: RTS, S/AS02A ( phase 3) Chagas disease, human African trypanosomiasis and Leishmaniasis in collaboration with DNDi Leishmaniasis: the company itself: Sitamaquine (WR6026) (phase 2b) Dengue: Vaccine (phase2) in collaboration with Pediatric Dengue Vaccine Initiative
Existing Commercial Products:
Company Rank
HIV, Malaria, Respiratory, Central nervous system , Metabolic Oncology and emesis, Cardiovascular and urogenital, Skin disease, Arthritis, Gastrointestinal Vaccine: Cervical cancer, Chickenpox, Diphtheria, Hepatitis A and B, Influenza, Measles, Meningitis, Mumps, Polio, Rotavirus, Rubella, Tetanus, Typhoid, Whooping cough (Pertussis), Pneumonia, otitis media and bacterial meningitis
1
Company Score
4.53
1 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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GlaxoSmithKline
Management Influence R&D Patenting Capacity Pricing Drug donations Philanthropy
0
1
2
3
4
5
2 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
A. Access to Medicines Management (20%) Weight
Indicators
Scores
A1. Governance: The company has a governance system that includes direct board level responsibility and accountability for its ATMs strategy. A2. Policy and Disclosure: The company has a public global policy in place, in which it explains its rationale for ATMs, its contents and details its specific objectives.
5
A3. Systems and Reporting: The company has a management system, including quantitative targets, to implement, monitor and report on its ATMs strategy.
5
25%
25%
A4. Stakeholder Input: The company has a mechanism for stakeholder engagement which inputs into ATMs management.
5
A5. The company has globally applicable ethical business practices and marketing policies that conform to appropriate standards.
5
10%
20%
20%
Company Rank
Comment
1
Company Score
5
5
GSK is a clear leader in access to medicines (ATMs). The group has a global ATMs policy that is governed through a clear management system, with accountability at the board level. GSK has a wide range of relevant ATMs programs including R&D investment into neglected diseases and the global disease burden, an equitable pricing policy, voluntary licensing, drug donations and philanthropic activities. GSK articulates the business case for ATMs mentioning "ethical, reputational and commercial reasons" for addressing the ATMs issue. In particular, GSK considers that addressing ATMs issues will help attract and retain highly skilled employees, maintain the intellectual property rights system, and secure long-term business opportunities in the developing world. GSK's reporting is very detailed. The company clearly states its long-term objectives and has defined a wide range of relevant key performance indicators to measure the impact of its activities and report on progress. GSK also relies on a third party to certify the accuracy of the information disclosed in the CSR report and that the ATMs section addresses the material aspects of ATMs as expected by GSK's stakeholders. Regarding stakeholder involvement, GSK maintains regular communication with relevant stakeholders on ATMs issues, and in particular in 2007 the discussions focused on R&D for neglected diseases, improving access to HIV drugs and improving access in middle-income countries. The "Tearing Down the Barriers" concept is a clear example of how stakeholders input into the company ATMs strategy (see equitable pricing for more details on this concept). GSK uses various means to communicate internally on ATMs. While the company has not come up with an indicator to measure the impact of its ATMs approach on employee morale, GSK recognizes its value. When interviewed by Innovest, the company mentioned that when traveling around the company the new CEO informally asked employees what they like about GSK and their first response was the commitment towards the developing world including R&D programs, pricing approaches, and community involvement.
3 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
B. Public Policy Influence & Advocacy (10%) Weight
5%
20%
20%
40%
15% Company Rank
Comment
Indicators
Scores
B1. The company has a position on public policy advocacy and transparency.
5
B2. The company and subsidiaries disclose major public policy positions at regional, national and international levels related to the ATMs debate. B3. The company and subsidiaries actively advocate health reforms that foster ATMs and policies that would result in improvements in public health.
5
B4. The company annually discloses which individuals, patient associations, political parties, trade associations and academic departments it supports with which it might advocate on public policy positions and practices; at a regional, national and international level. B5. The company demonstrates a process of board approval of the approach to public policy advocacy, its transparency and reporting.
4
2
Company Score
5
5
4.6
GSK recognizes stakeholders’ concerns about lobbying by pharmaceutical companies and therefore issues a clear commitment towards transparency in public policy advocacy and lobbying. Like its peers, GSK lobbies policy makers and stakeholders to shape public health policy and ATMs. However, compared to its peers in the sector, GSK discloses information on advocacy activities undertaken by the company in 2007. It mentions examples like urging the G8 to continue making healthcare in the developing world a major agenda item, working with UK Department for International Development (DFID) on its Medicines Transparency Alliance (MeTA), providing evidence to the EU Parliament’s Committee on International Trade to encourage ratification of the WTO compulsory licensing for export protocol etc. GSK also states its position on major ATMs debates like the issuance of compulsory licenses by the Thai government or the intellectual property (IP) system in India. GSK recognizes that compulsory licenses are a legitimate option but calls for more dialogue with the Thai government before a license is issued. As for India, GSK thinks that developing an IP system similar to the European or American standards would help foster innovation to the benefit of patients and the Indian economy as a whole. GSK adds that it is working on an equitable pricing policy to help facilitate ATMs to those in need in India; however, the company maintains that poverty and a lack of healthcare infrastructure are the main barriers, not prices. Additionally, advocacy is a key component of several of the company's community programs, notably malaria and Lymphatic Filariasis (LF). Regarding industry associations, GSK is a member of several industry organizations, but the company states that it will not participate in advocacy activity, if it disagrees with industry positions. Commendably, GSK also mentions examples of positions it wants to pursue within the industry and in particular a code of good practices on relationships with patient organizations. GSK has set more stringent standards for itself with regards to patient organizations and was the first European company in 2007 to publish information on all its work with European patient groups including details of the funding received. In 2008, GSK extended the scope of disclosure to include international support.
4 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline GSK also complies with legal requirements to report on lobbying expenses and it spent USD 8.24 million in federal lobbying activities in the US during 2007. Lastly, GSK has developed an Employee Guide to Business Conduct which commits employees to acting with honesty and integrity in their lobbying activities. A Corporate Executive Team reviews the company's advocacy activities.
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
C. R&D that Reflects both the Global Disease Burden and Neglected Diseases (20%) Weight
Indicators
5%
C1. The company has a policy on R&D investment that reflects both the global disease burden and neglected diseases.
5
C2. The company provides evidence of in-house investment in R&D into new treatments for neglected diseases.
5
30%
C3. The company with in-house investment in R&D into new treatments for neglected diseases provides evidence of partnership with groups with developing-country health expertise, such as product development public-private partnerships, academic institutions and/or the World Health Organization.
5
C4. The company shows temporal evidence that its research programs into both the global disease burden and neglected diseases consider research into existing medicines and formulations suitable for use in developing and least developed countries and for affected patient groups.
5
40%
25%
Company Rank
Comment
1
Company Score
Scores
5
GSK is a leader in R&D for neglected diseases. The company is involved in R&D for new treatments for malaria, TB, leishmaniasis, sleeping sickness and Chagas disease and is investing in vaccines for AIDS, TB, dengue fever and Malaria. A third of its vaccine pipeline is for diseases of the developing world. In 2008, GSK had 12 ongoing clinical programs, seven of which were focused on neglected diseases. The company has both in-house and collaborative R&D. GSK has a dedicated site called, The Diseases of the Developing World Drug Discovery Centre at Tres Cantos. The R&D center employs 105 scientists that are solely dedicated to the discovery of new medicines for neglected diseases with a special focus on malaria and TB. The TB Alliance supports 25 full-time scientists at Tres Cantos, while GSK contributes a matching number of staff and remaining overhead costs. The Medicines for Malaria Venture (MMV) is subsidizing 30 scientists at the Tres Cantos facility and also provides input from its expert scientific Advisory committee. A similar group exists in the vaccines organization based in Belgium. GSK does not expect to make profit on new treatments for neglected diseases and therefore works in partnerships to share the R&D costs and ensure affordable prices of new treatments for poor patients in the developing world. In the area of TB, GSK and the TB Alliance announced the renewal of their partnerships for drug discovery in 2008. GSK is also collaborating with the Aeras Global TB Vaccine Foundation to develop a candidate vaccine against TB. In the area of malaria, GSK is partnering with MMV on new treatments and is internally working on a candidate malaria vaccine for children, which is in phase 2 clinical trial in Africa. In the area of leishmaniasis, sleeping sickness and Chagas disease, GSK has recently entered into a partnership with DNDi. GSK is also funding the development of a new once-a-day oral treatment for visceral leishmaniasis. This example clearly reflects GSK's commitment to considering developing country context when researching on a new treatment. GSK emphasizes factors such as heat and humidity and easy to use to ensure appropriate use in the developing world. GSK has been working on a malaria vaccine for over 20 years and have invested over USD300 million to date. A pivotal Phase III trial is now planned, which, if successful, could result in submission to regulatory authorities in 2011. 6
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
D. Patents & Licensing (10%) Weight
60%
40%
Company Rank
Comment
Indicators
Scores
D1. The company demonstrates the existence of, and discloses the terms of, non-exclusive voluntary license agreements to increase ATMs in developing countries.
5
D2. The company publicly commits itself to respecting the right of developing countries to use the provisions in the TRIPS agreement.
2
1
Company Score
3.8
Like its peers, GSK considers that intellectual property rights are essential to boost innovation and are not barriers to ATMs. Commendably, GSK demonstrates its willingness to use pathways to protect its discoveries while improving access to its HIV drugs. Since 2001, the company has entered into eight voluntary licenses with local companies in Africa. These practices are successful as licensees supplied 183 million tablets of their versions of Epivir and Combivir to Africa in 2007. This represents a more than 50% growth over 2006. GSK also granted a voluntary license to Simcere, a Chinese manufacturer, giving it the right to manufacture and sell zanamivir, an antiviral for the treatment of flu, in China, and to sell in a number of other countries including all 50 of the least-developed countries (LDCs). In August 2007, GSK also agreed to enable a Canadian company, Apotex, to manufacture a generic fixed-dose combination ARV, containing two molecules over which GSK has patent rights, for the treatment of HIV/AIDS in Rwanda. This practice is in line with WTO 31F agreement. GSK clearly states its position on TRIPS with regards to Thailand and India (see Public Policy Influence & Advocacy) and withdrew a patent application for Combivir in India. In 1997, GSK had applied for a patent for Combivir in India. In August 2006, this application was the subject of protests by the civil society in India, but GSK had instructed the patent application to be withdrawn in a number of countries, including India, prior to this date. However there are allegations that the company suggested that the UK government should intervene with Thailand about its compulsory licensing policy. It also certainly persuaded Peter Mandelson to write to Thailand several times about their compulsory licensing policies.
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
E. Drug Manufacturing, Distribution and Capability Advancement (15%) Weight
Indicators
E1. The company demonstrates efforts to manufacture drugs to the highest quality standards.
5
20%
E2. The company enters into technology transfer agreements with local companies in developing and least developed countries. E3. The company undertakes external activities to support the monitoring of drugs that reflect both the global disease burden and neglected diseases including participation in public private partnerships.
3
20%
E4. The company has mechanisms in place to help prevent product diversion and to address counterfeiting, in collaboration with states.
4
E5. The company demonstrates efforts to provide ATMs to its employees and their relatives in developing and least developed countries.
4
10%
35%
15%
Company Rank
Comment
4
Company Score
Scores
3
3.7
GSK recognizes the inadequate healthcare infrastructure in developing and leastdeveloped countries. Specifically with regard to voluntary licensing, GSK is aware of limited infrastructure and carefully selects licensees with adequate manufacturing capabilities allowing them to ensure long-term supply of good-quality drugs. However, other policies stating safeguards or measures to prevent manufacturing faults associated with poor infrastructure are not disclosed. GSK considers that drug manufacturing is the responsibility of the licensee and the local drug regulatory authority. Relating to technology transfers GSK signed a technology transfer agreement with the Brazilian government institute, Fiocruz, to produce Rotarix for the domestic market and manufacture Rotarix for GSK under contract for export to other developing countries. A similar agreement exists in Brazil for GSK's oral polio vaccine, Haemophilus influenzae type b (Hib) vaccine and measles, mumps and rubella vaccine. Additionally GSK has a drug discovery and clinical development collaboration covering a wide range of therapeutic areas with Ranbaxy in India. GSK also supports the INDOX program where they are training clinicians from 12 Indian oncology centers through collaboration with the University of Oxford. Indian clinicians spend some time at Oxford within the oncology department at the Radcliffe Hospital to supplement their online learning to bring them up to good clinical practice. GSK supports this operation through UKIERI. GSK is also proactive in improving pharmacovigilance systems in the developing world. In 2006, GSK organized a meeting on pharmacovigilance with African clinicians, African regulatory representatives and WHO representatives to identify challenges and share best practice between HIV and malaria pharmacovigilance. The company has operations in the developing world and has a policy to offer HIV drugs to all HIV positive employees and their families in countries where treatment is not available through the local healthcare system. GSK has implemented a program on HIV in the workplace, Positive Action At Work. Finally GSK has developed relevant programs to prevent product diversion and counterfeiting in collaboration with states, pharmacists, wholesalers and other pharmaceutical companies.
8 © Access to Medicine Foundation 2008 Source: Retrieved September 14, 2009, from www.atmindex.org
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
F. Equitable Pricing (15%) Weight
Indicators
Scores
20%
F1. The company can demonstrate efforts to register treatments that 4 reflect both the global disease burden and neglected diseases in developing and least developed countries. F2. The company has a policy to facilitate ATMs in developing and least developed countries through pricing mechanisms which include reporting on scope, pricing levels and pricing reviews.
5
50%
10%
F3. The company demonstrates that its discount schemes place the minimum administrative burden on the beneficiary health system.
5
F4. The company has a policy for the very poorest in countries with no public healthcare provision.
5
20% Company Rank
Comment
1
Company Score
4.8
GSK is committed to registering its drugs worldwide, and there is no evidence that the company is involved in registration problems. Commendably, GSK strives to speed up the registration process in the developing world by using mechanisms such as the European Medicines Agency (EMEA), Article 58. In 2007, GSK had products listed in 17 out of 27 therapeutic areas on the WHO Essential Medicines List. GSK has implemented a sound equitable pricing policy for its ARVs, anti-malarials and its vaccines. The company offers not-for-profit prices (nfp) to NGOs and the public sector in all LDCs and all of SSA and to all fully funded CCM projects of the Global Fund and to The US President's Emergency Plan for AIDS Relief (PEPFAR) projects. In SSA, GSK offers nfp to private employers who provide healthcare benefits to their uninsured staff. For middle-income countries (MIC) the company states that it will negotiate on a case-by-case basis. Since 1997 and the creation of its equitable pricing policy, GSK has decreased the price of its ARVs five times. The most recent announcement in February 2008 represented a 21% decrease on average across GSK’s ARVs pipeline. This price drop is due to improvements and efficiencies in manufacturing and supply, and reductions in the costs of active ingredients. Commendably, GSK discloses the number of drugs shipped at nfp in the developing world. The number has been reduced in 2007 due to the increase of supply by GSK's licensees (see Patents & Licensing). With regard to vaccines, for over 20 years, GSK has made its vaccine portfolio available at preferential prices to developing countries, using a tiered pricing system. Prices are linked to gross national incomes as defined by the World Bank as well as the size of an order and length of a particular supply contract. For the developing world prices can be as little as a tenth of those for developed countries. In 2007, GSK shipped 1.1 billion vaccines, 78% went to the developing world in collaboration with the WHO, GAVI, UNICEF and Pan-American Health organization. Thanks to a large volume of sales and long-term contracts, GSK has been able to reduce the price of the dose. Most noticeably, GSK is working on a concept called "Tearing Down the Barriers" to develop pricing mechanisms for private and public sector markets in MIC. The company is working on pilot projects including "tiered-pricing models within as well as between countries; a system to gauge the relationship between price and volume for selected products in targeted middle-income countries; and differential branding strategies in targeted middle-income countries." GSK is also considering pricing mechanisms for treatments for diabetes, lung cancer, cardiovascular diseases and bacterial infections as part of "Tearing Down the Barriers". Finally GSK is heavily involved in the developed world. In 2007, more than 484,000 US patients received GSK medicines worth almost USD 388 million compared with USD 370 million in 2006. GSK has also introduced discount cards in Bulgaria and Lithuania to enable poor people with chronic diseases to obtain prescription medicines at a discount price. 9
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
G. Drug Donations (6%) Weight
Indicators
Scores
60%
G1. The company has a policy that fully conforms to the WHO’s Guidelines for Drug Donations.
5
G2.The company discloses the absolute volume of its drug donations and, to the extent possible, the number of treatments approved for patient use per year.
5
40%
Company Rank
Comment
1
Company Score
5
GSK is committed to the development of long-term, sustainable solutions to the challenges relating to the availability of its medicines. Drug donations do not form a central component of the company's policies to increase sustainable ATMs. GSK has a drug donation policy that is in line with the WHO’s guidelines on drug donations. It recognizes that donations are relevant in emergency situation and/or as part of an eradication program. Therefore in 2007, GSK donated medicines valued at GBP 16 million to support disaster and humanitarian relief in 107 countries. In addition to donations of antibiotics and other essential medicines, as part of its partnership with the WHO's Global Alliance to Eliminate Lymphatic Filariasis, GSK has donated almost 750 million albendazole treatments since 1998. Additionally, in 2007, GSK announced its intention to donate 50 million doses of its pre-pandemic H5N1 flu vaccine to the WHO stockpile. In the event of an outbreak these can be rapidly distributed to the world’s poorest countries.
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Appendix F: Access to Medicine Index Report (cont.)
GlaxoSmithKline
H. Philanthropic Activities (4%) Weight 100% Company Rank
Comment
Indicators
H. The company has philanthropic programs related to ATMs not covered by any of the other criteria. 9
Company Score
Scores
3 3
In 2007, GSK's philanthropic activity was valued at GBP 282 million compared with GBP 302 million in 2006. This is equivalent to 3.8% of the company's pre-tax profits (3.9% in 2006). Through its Global Community Partnerships program, GSK funds community-led initiatives in over 100 countries around the world. GSK has a wide range of philanthropic programs and partnerships with a focus on health and education programs for under-served communities, and maintains robust relationships with its partners to ensure the effectiveness and the sustainability of these programs. As mentioned in the Drug Donations section, GSK is collaborating with the WHO's Global Alliance to Eliminate Lymphatic Filariasis. In 2007, the company gave GBP 1 million to support alliance partners and has employees helping on advocacy, research and education. Through its Positive Action program founded in 1992, GSK is also working on education, capacity building and support to local organizations on HIV/AIDS in 19 countries. It is also involved in advocacy on malaria in Europe and Africa. Lastly, GSK invests significantly in diarrheal disease with programs such as PHASE – hygiene and sanitation education program now running in 12 countries. This program shows favorable results as diarrhea rates have decreased by 40% in participating schools since the introduction of PHASE to schools in Kenya.
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Appendix G: GSK Public Relation Tactic 1
GSK to strip down through outsourcing and offshoring
http://www.drugresearcher.com/Research-management/GSK-to-strip-dow...
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GSK to strip down through outsourcing and offshoring
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GlaxoSmithKline (GSK) is planning to strip itself down closer to the bare bones of the business through further outsourcing and offshoring, with hopes of making itself into a lean, mean, pharma machine. The pharma heavyweight announced a sweeping restructuring plan in the form of an 'Operational Excellence' programme, designed to achieve savings of up to £700m (€1bn) by 2010 - 40 per cent of which will come from cutting down on manufacturing sites and simplifying production processes and activities to reduce over capacity. The cornerstones of this new programme are "persistent focus across all functions; a reduction in complexity, to be achieved by standardisation, consolidation, outsourcing and offshoring; and the exploitation of global opportunities, in regard to procurement, skills, labour cost and arbitrage," indicated GSK's CEO Dr J.P. Garnier. As with most pharm firms in today's tough business climate, GSK has already been embracing outsourcing and offshoring to a certain extent in order to tighten its purse strings, however, as more parts of the business are seeing the fruits of this strategy, the firm is stepping up its resolve in this regard.
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"Basically, we are good at standardising and outsourcing when it's not a core activity that we want to manage ourselves. The arbitrage that is now available through the global world in which we live is a phenomenal opportunity and we are taking full advantage," said Garnier during an analyst call covering GSK's third quarter results.
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"We are now in a position to basically accelerate what we've been doing all along," he said, without going into much further detail.
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Garnier highlighted the business areas the firm has already been either offshoring or doling out to third parties: clinical trials; human resources; IT, data management and shared financial services; and back-office functions. In addition, the firm has established a commercial analytics centre in India, conducted a rationalisation of its manufacturing network, and now undertakes global procurement across all functions.
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The company's selling, general and administrative (SG&A) costs as a percentage of turnover, were 35.0 per cent in 2001, and now nine months into 2007 they sit nearly six percentage points lower at 29.4 per cent. "This is an example of those savings," said Garnier. "Even in the years where we didn't have significant growth in revenues, for instance, the year we lost Paxil and Augmentin, we were still able improve the SG&A ratio every time, and I expect this to continue in the future". In terms of manufacturing, GSK has big plans for slimming down an already shrinking in-house capability over the next three years. In 2000 GSK owned 108 manufacturing sites, by 2006 this had been cut by 28 to 80 and the firm is anticipating similar cuts by 2010. Meanwhile, in 2001 only 9 per cent of the firm's primary active pharmaceutical ingredient (API) costs were outsourced, now that figure has jumped to 41 per cent and continues to climb. "We think that over the next three years we will be able to make significant inroads, which means first of all, that the percentage of our primary cost is going to be different in three years in terms of outsourcing," said Garnier, adding that the company had in an internal target in place for this. "But, the point is that outsourcing is going to grow, particularly, when you look at the share of the multi-sourced business we are still manufacturing and we have a number of products going generic, which are now fair game for potential outsourcing. So, that's what it's all about with manufacturing, a more efficient network at the end of the day." However, GSK is only willing to relinquish control of production when it feels products are established enough to warrant outsiders picking up some of the work: "What we want is to protect our new products… We don't want anybody to have control over our new products - for commercial reasons, but also for ethical reasons. We don't want people to make our oncology products because if they go wrong [or] out of stock, we are killing people", said Garnier. As such, he indicated that the company wants to retain manufacturing control of all new products until they become multi-sourced. After that time, the firm is less bothered as to whether products are made in house or by third parties, but with Garnier's caveat that "if we can buy it cheaper than we can make it then of
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Appendix G: GSK Public Relation Tactic 1 (cont.)
GSK to strip down through outsourcing and offshoring
http://www.drugresearcher.com/Research-management/GSK-to-strip-dow...
course that's what we're going to do." A GSK spokesperson told Outsourcing-Pharma.com that at this point, the company cannot comment on who or where the potential beneficiaries of its outsourced work may be: "It will be decided on a case-by-case basis." What is known is that job cuts are planned. The majority of details have not been finalised regarding which sites would be axed, nor how many employees could be affected, although the company has said that troubled Cidra, Puerto Rico, plant would be the first to fall to its axe, with news on a number of UK plants fast on its heels.
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In terms of the effect this will have on the company's margin, Garnier told analysts that "clearly there will be significant improvement in terms of the cost saving program," although he warned that they may not materialise straight away.
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There are site closures and so some of the benefits of the cost saving programme will come toward the end of the [three year] cycle.
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Speaking on the company's ongoing plans to reduce infrastructure and improve efficiency, Garnier said that the firm now has a chance to expand these efforts a little bit beyond the classic areas of selling, general and administrative (SG&A) and manufacturing to also include research and development (R&D) and sales. In terms of R&D, the company has plans to increase the number of external collaborations it undertakes as well as embrace the budget option that is Asia. Only earlier this week, in fact, the company announced a multi-million dollar deal with Tolerx to develop and commercialise otelixizumab, a humanised anti-CD3 monoclonal antibody. Many other such preclinical collaborative deals are already in place with an array of specialist firms. Meanwhile, in July, GSK announced its intention to plant itself in China and establish a new R&D center to be based in Shanghai, which will eventually have full global responsibility to create medicines for neurodegenerative disorders, and also be well positioned to tap into the vast number of Chinese PhD graduates. The company is already quite active on the Indian pharma scene and now has its eye scanning for opportunities in other emerging Asian regions. "In terms of R&D, we have to talk first about where we are going to super invest," said Garnier. "We are building biologicals, first of all with some in-licensing but also with our own molecules…Of course we will also accelerate our establishment of R&D in China." Garnier pointed out that the company is looking at up to 25 new launches over the next three years, with products "that will come right on time…to replace what we are losing to the generics."
MORE NEWS ARTICLES ON THIS TOPIC GSK's UK plant to lose out to outsourcing China CRO attracts $30m US investment Nycomed takes bulk of API production offshore Pharma should keep outsourcing in mind GSK reviews Montrose API plant GSK buys Reliant for cardiovascular drugs Kemwell forges consumer health partnership with GSK GSK cut down by Avandia scare GSK axe begins to fall Copyright - Unless otherwise stated all contents of this web site are © 2000/2009 - Decision News Media SAS - All Rights Reserved - For permission to reproduce any contents of this web site, please email our Syndication department: Administration & Finance - Full details for the use of materials on this site can be found in the Terms & Conditions
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Appendix H: GSK Public Relation Tactic 2
GlaxoSmithKline: CR Report 2004 - Preferential pricing
http://www.gsk.com/responsibility/cr_report_2004/am_dc_preferential_p...
Search GSK.com
CR Report 2004 CEO/Chairman statement Employment practices Human rights Access to medicines Developing world Research & development Preferential pricing Eligibility for not-for-profit prices Voluntary licensing and partnerships
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Home Responsibility CR Report 2004 Access to medicines Preferential pricing
Preferential pricing
Preferential pricing There are many barriers to healthcare in developing countries. Most significantly, poverty, and a lack of political will, have led to a lack of medical infrastructure hospitals, clinics and medical professionals - that prevents poor people accessing the healthcare they need. The affordability of medicines is also important and there are two elements to this. First is the ability of governments or patients to pay for medicines. Solving this problem will require developed country governments and inter-governmental agencies to make significant additional financial resources available to developing countries. The second element is the price at which medicines are sold, an area GSK can help to address. We are making key medicines available to developing countries at more affordable prices and in sufficient quantities for as long as they are required. This is a major commitment that we call ‘preferential pricing’. All our AIDS and malaria treatments are available at not-for-profit prices to public sector customers and not-for-profit organisations in over 100 developing countries, including all the countries covered by the US President’s emergency plan for AIDS Relief (PEPFAR). Our prices are sustainable - we do not make a profit on them, but we do cover our manufacturing and distribution costs. Therefore we can sustain supply of these products for as long as they are needed. We aim to reduce not-for-profit prices for our ARVs and anti-malarial medicines whenever improvements in manufacturing, or economies of scale, allow. For example, Combivir, one of our key ARVs, is now available at $0.65 a day, compared with $1.70 in April 2003. This equates to around $237 per patient per year and includes delivery costs, which compares favourably with generic tablets. The February 2005 pricing report by Medecins Sans Frontieres shows that the average cost of generic equivalents is $0.75 a day and the lowest priced generic equivalent costs $0.55 a day. In addition, we negotiate public sector prices with middle-income developing countries on a case-by-case basis. These combine a viable and sustainable commercial return for GSK with increased affordability for the healthcare systems concerned. GSK vaccines are also available at preferential prices. Here we work with multinational organisations such as UNICEF, the World Health Organisation and the Pan American Health Organisation, governments and non-governmental organisations, to provide appropriate and affordable vaccines for the developing world.
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Learn more about Preferential pricing US President’s emergency plan for AIDS relief (PEPFAR)
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Progress in 2004 In 2004 we shipped 32.7 million preferentially-priced Combivir tablets to the developing world, with over 80% of these going to Africa. This is nearly three times the 11 million tablets shipped in 2003. We do not routinely collect data for our other preferentially-priced medicines but a similar increase has been experienced for Epivir, another of our ARVs. Overall shipments are still low given the scale of the AIDS epidemic in Africa but the growth is encouraging. More doctors, hospitals and clinics are needed to treat more patients and ensure better take up of preferentially priced medicines. Shipments of preferentially priced Combivir excluding diverted stock
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Appendix H: GSK Public Relation Tactic 2 (cont.)
GlaxoSmithKline: CR Report 2004 - Preferential pricing
http://www.gsk.com/responsibility/cr_report_2004/am_dc_preferential_p...
2001
2002
2003
2004
(millions of tablets) 3.5
6
11
32
It is difficult to estimate the number of patients treated as a result of our preferential pricing agreements, since GSK does not control healthcare provision. A report from the UN-led Accelerating access initiative (AAI), suggests that by September 2004 more than 333,000 patients in developing countries were receiving ARV treatments supplied by the seven pharmaceutical companies in the AAI. This includes 157,500 patients in Africa, a 50% increase since September 2003. For more on GSK’s work with the AAI see Accelerating Access Initiative. At the end of 2004 we had 208 arrangements to supply preferentially-priced ARVs in 57 countries. This includes 30 agreements with private employers. We added new supply agreements with a number of middle-income countries during 2004. These include an agreement with the Chinese Ministry of Health for preferentially priced Epivir tablets to support China’s national HIV treatment programme, and a number of arrangements in Central and Eastern Europe. We are also introducing discount cards for senior citizens in several middleincome countries, see Developed world.
Supply arrangements by type of customer
Supply arrangements by type of customer 2000 AAI
2001
q4
q1
q2
q3
q4
2
4
10
13
17
Govt non
4
AAI
12
q1
2002
q2
q3
q4
q1
q2
q3
NGOs Public
5
hospitals
8
13
Employers
19
31
2
13
2003 AAI Govt non
2004
q4
q1
q2
q3
q4
2
4
10
13
17
q1
q2
q3
4
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Appendix H: GSK Public Relation Tactic 2 (cont.)
GlaxoSmithKline: CR Report 2004 - Preferential pricing
AAI
http://www.gsk.com/responsibility/cr_report_2004/am_dc_preferential_p...
12
NGOs Public hospitals
5 8
13
19
31
GSK in focus | Your health | Reports and publications | GSK worldwide | Contact us | Site map Terms and conditions | Accessibility | Your privacy | Procurement | Flu Information Source for GSK employees
Updated 30 January 2006 © 2001 - 2009 GlaxoSmithKline plc. All rights reserved. Registered in England and Wales No. 3888792. Product diversion, where not-for-profit medicines are illegally shipped back for Registered office: 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Employers
2
13
sale in wealthier countries, undermines our ability to provide not-for-profit prices and denies treatment to the intended patients in poorer countries. We can only afford to supply products at low prices in the world’s poorest countries if we can still make an adequate return on them in wealthier markets. We have introduced different packaging and tablet colours for many of our not-for-profit medicines to help prevent product diversion. Special tri-lingual ‘access packs’ are now approved for Combivir, Epivir and Trizivir in over 50 countries, and we are now receiving regulatory approvals for the red Epivir and Combivir tablets. GSK has nine ARVs registered under the EU’s Anti-Diversion Regulation. We are the only company to have registered products under this Regulation. We have set up five pilot projects in collaboration with NGOs in Tanzania, Uganda, Nigeria, Zambia and Malawi to assess the impact of extending preferential pricing to a wider range of products. Initial results show that lack of healthcare capacity and infrastructure are major barriers. When capacity (for example the number of healthcare professionals) or funding is improved there is an increase in take up of preferentially-priced medicines. For example two of the pilot sites have received funding from the US President’s Emergency Plan for AIDS Relief for the treatment of opportunistic infections. This has led to an increase in orders for antibiotics. A report on the findings from the pilots will be prepared at the end of 2005. Back to top
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Appendix I: GSK Public Relation Tactic 3
Developed world - CR Report 2005 - GlaxoSmithKline
CR Report 2005
http://www.gsk.com/responsibility/cr_report_2005/access-to-medicines/...
Home Responsibility CR Report 2005 Access to medicines
Developed world
Summary and highlights CEO/Chairman statement About this report Managing CR Access to medicines Developing world Developed world Research Ethical conduct Employees Human rights Environment Community investment Data summary Case studies PDF downloads Report index Feedback
Developed world Access to medicines is not just an issue for the developing world. Even in developed countries some patients cannot afford the medicines they need. This is a particular problem in the US where many people do not have health insurance. GSK has developed Patient Assistance Programs and discount cards in the US to help patients without insurance. We are also introducing discount cards in several middle-income countries to enable qualifying patients to obtain prescription medicines at a discount price. Programmes in the US Patient Assistance Programs provide prescription medicines to low-income, uninsured patients free or at minimal cost. GSK operates several programmes, including Commitment to Access which covers cancer treatments and Bridges to Access which covers other medicines for outpatients. Patients are registered through one phone call from a patient advocate and receive medicine at their local pharmacy or by mail order. In 2005, 565,000 patients received GSK medicines worth $463.8 million through these programmes, compared with $372.5 million in 2004. The value of the medicines is calculated using the wholesale acquisition cost (WAC).
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GSK was the first pharmaceutical company in the US to offer a card providing savings on medicines to low-income senior citizens and disabled people. Known as the Orange Card this enabled these people to buy GSK outpatient prescription medicines at a discount of up to 40%. In 2005, 205,672 Orange Card holders received 49,084 prescriptions, saving $5 million (based on WAC). In 2002, GSK and six other pharmaceutical companies established the Together Rx card which provided discounts on over 155 prescription medicines for low-income senior citizens who are eligible for Medicare. In 2005, 347,835 people received 463,901 GSK prescriptions through this programme, saving $7.5 million (based on WAC). Our access programmes in the US will change significantly in 2006 with the launch of a new Medicare prescription drug coverage programme. The Orange Card and Together Rx programmes finished on 31 December 2005 as those patients are now eligible for the new Medicare programme. We will report on the roll-out of these changes next year. In January 2005, GSK and nine other pharmaceutical companies created a new card to improve access to medicines for other uninsured Americans, not just seniors. The Together Rx Access card provides savings of 25-40% on more than 275 medicines. Approximately 36 million people, around 80% of uninsured people in the US, are eligible to enrol. The participating companies enrolled 353,113 people in 2005, who received 647,227 prescriptions worth $10.1 million (based on WAC). GSK assisted 10,947 of these patients, with 31,617 prescriptions, worth $2.9 million. Orange Cards in middle income countries In 2004 GSK introduced Orange Cards providing discounts on certain GSK prescription medicines for eligible patients in Bulgaria, Lithuania and Ukraine. The nature of the discounts varies between countries, depending on the needs of the patient and the way in which the healthcare system operates. Our Orange Card in the Ukraine gives all asthma and chronic obstructive pulmonary disease patients who are under 25 or over 50, an average discount of 19% on GSK’s Seretide asthma medicine. Asthma patients of any age who suffer disabilities or who are affected by the Chernobyl nuclear disaster are also eligible.
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Source: Retrieved October 25, 2009, from www.gsk.com/responsibility/cr_report_2005/access-to-medicines/developed-countries.htm
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Appendix I: GSK Public Relation Tactic 3
Developed world - CR Report 2005 - GlaxoSmithKline
http://www.gsk.com/responsibility/cr_report_2005/access-to-medicines/...
Eligibility is assessed by the patient’s doctor and patients can receive the medicine at participating pharmacies. A hotline number has been set up to help patients find their nearest pharmacy. In 2005, 3,500 patients enrolled and received discounts worth $176,000. In Lithuania, our Orange Card gives senior citizens an average discount of 40% on the patient co-payment on all GSK prescription medicines. So far more than 12,000 patients have applied for an Orange Card and 155 pharmacies are registered to participate. In 2005, 3,000 patients received discounts worth £20,000 ($36,400). In December we widened the group who are eligible for the Orange Card to include disabled people. A GSK Orange Card was also introduced in Bulgaria in May 2004 for low-income patients with chronic diseases such as asthma, chronic obstructive pulmonary disease and diabetes. Card holders receive an average 35% discount on four GSK prescription medicines. In 2005, 36,000 patients received discounts worth over Euro 1.4 million ($1.75 million)
Summary of GSK discount programmes Value of Benefit to Patients
Country
GSK Programme
Number of Patients
US
Patient Assistance Programs Free or minimal cost medicines for low-income, uninsured patients.
565,000 received prescriptions
$464 million
US
Orange Card - Discounts for low-income senior citizens and disabled people.
205,672 received prescriptions
$4.992 million
US
Together Rx - Discounts for low-income senior citizens. Joint industry programme.
347,835 received prescriptions
$7.561 million
US
Together Rx Access - Discounts for all low-income uninsured patients. Joint industry programme.
10,947 received prescriptions
$2.912million
Bulgaria
Orange Card - Discounts for low-income patients with chronic diseases.
36,000 patients received prescriptions
$1.75 million
Lithuania
Orange Card - Discounts for senior citizens and disabled people
12,000 enrolled
$36,400
Ukraine
Orange Card - Discounts on asthma medicine for patients under 25 or over 50.
3,500 enrolled
$176,000
Back to top
GSK in focus | Your health | Reports and publications | GSK worldwide | Contact us | Site map Terms and conditions | Accessibility | Your privacy | Procurement | Flu Information Source for GSK employees
Updated 30 January 2006 © 2001 - 2009 GlaxoSmithKline plc. All rights reserved. Registered in England and Wales No. 3888792. Registered office: 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
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Appendix J: GSK Public Relation Tactic 4
Advocacy on pricing and competitiveness - Public policy activity in 2008 ...
http://www.gsk.com/responsibility/advocacy-on-pricing-and-competitive...
Home Responsibility Public policy and patient advocacy Public policy activity in 2008 Advocacy on pricing and competitiveness
European activity Guiding principles for relative effectiveness assessments and pricing Organisations engaged: EU member states, the European Commission, stakeholder representatives participating in the EU’s High Level Pharmaceutical Forum Industry associations involved: EFPIA, EuropaBio GSK position: Government funding decisions are often based on an assessment of a medicine’s clinical or cost effectiveness. We believe that these value assessments should be conducted transparently and in a timely manner and all key stakeholders should be able to submit evidence for the assessments. Governments should allow greater pricing flexibility when the long-term value of a medicine is not certain at launch. GSK, representing EFPIA, strongly supported the Good practice principles for relative effectiveness assessments which were developed within the framework of the EU’s High Level Pharmaceutical Forum (HLPF). These were adopted in 2008 along with the Guiding principles for good practices implementing a pricing and reimbursement policy. EFPIA’s Health Technology Assessments principles, which the industry has previous adopted and that GSK helped to develop, are aligned with the principles adopted by the HLPF. Improving regulations that impact on the pharmaceutical industry’s competitiveness in the UK Organisations engaged: UK government and the European Commission Industry associations involved: ABPI, CBI, Institute of Directors GSK position: The pharmaceutical industry is one of the most highly regulated industries in Europe. GSK supports strong regulation but has been working with the UK government and the European Commission to propose ways to simplify regulations while achieving the same policy goal. This aligns with the aims of the UK government and European Commission to reduce the regulatory burden placed on industry. GSK submitted a series of 50 proposals to the UK government for simplification 1 of 2
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Appendix J: GSK Public Relation Tactic 4, (cont.)
Advocacy on pricing and competitiveness - Public policy activity in 2008 ...
http://www.gsk.com/responsibility/advocacy-on-pricing-and-competitive...
of existing regulations. We also made a similar submission to the Commission, focusing on regulations that originate at a European level. Back to top
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Source: Retrieved October 25, 2009, from www.gsk.com/responsibility/advocacy-on-pricing-and-competitiveness.htm
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Legislative Education Campaign National Treatment Education Training Human Immunodeficiency Virus and Methicillin Resistant Staphylococcus Aureus: A Live National Satellite Videoconference and Webcast Series 2009 Annual Meeting Fellows-in-Training Program 2009 Annual Meeting Fellows-in-Training Travel Scholarships 2009 Fellows Career Development Awards 2009 Virtual Annual Meeting Controversial Topics in the Management of Rhinitis Pulmonary / Critical Care and Allergy / Immunology Fellows Career Development Awards Program Wisconsin Allergy Society 2008 Annual Meeting 60th Annual Scientific Assembly & Exhibition Asthma Control: Making the Best Decision Managing the Patient with Hypertriglyceridemia: A Practical Approach for Nurse Practitioners Patient Counseling Manual on the Topic of Hypertriglyceridemia Diagnosis and Management of Rhinitis: A Continuing Medical Education Curriculum 2008 Chemistry in Cancer Research Award Support District IV 2009 Meeting Providing Education and Training for Veterinarians, Managers, Supervisors and Technicians Support the Development of Public Outreach Projects about Laboratory Animal Research and Medical Research American Association of Clinical Endocrinologists: Diabetes Day for Primary Care Georgia Chapter of the American Association of Clinical Endocrinologists Annual Meeting and Symposium Support Second Annual Frontiers in Medicinal Chemistry Conference Donation for the H. C. Brown Award Symposium Continuing Medical Education Review Articles in the Annals of Allergy, Asthma & Immunology 41st Annual New York Cardiovascular Symposium
Acquired Immune Deficiency Syndrome Project - Alabama
Acquired Immune Deficiency Syndrome Project - Los Angeles
Albany Medical College
American Academy of Allergy
American Academy of Allergy
American Academy of Allergy
American Academy of Allergy
American Academy of Allergy
American Academy of Allergy
American Academy of Allergy
American Academy of Family Physicians Georgia Chapter
American Academy of Family Physicians Texas Chapter
American Academy of Nurse Practitioners
American Academy of Nurse Practitioners
American Academy of Physician Assistants
American Association for Cancer Research
American Association for Laboratory Animal Science - RTB
American Association for Laboratory Animal Science Foundation
American Association of Clinical Endocrinologists
American Association of Clinical Endocrinologists
American Chemical Society
American Chemical Society Division of Organic Chemistry
American College of Allergy & Immunology
American College of Cardiology Foundation
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Corporate Sponsorship Program for 2008-2009
Project Description
4th Quarter 2008
Academy of Surgical Research
Organization Name
Appendix K: GSK Public Relation Tactics 5 & 6
Grants & Charitable Contributions to US Based Healthcare Organizations
GlaxoSmithKline Public Relations Plan & Case Study
1
$5,000
$29,696
$1,000
$1,000
$5,000
$31,725
$7,600
$1,900
$15,000
$67,310
$32,804
$52,186
$5,000
$5,000
$3,200
$450,000
$47,500
$45,000
$400,000
$27,500
$25,000
$2,500
$25,000
$10,000
$3,800
Amount
Page 445
10th National Conference on Anticoagulant Therapy Managing Human Papillomavirus: A New Era in Patient Care
Anticoagulation Forum, Inc.
Association of Reproductive Health Professionals
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Annenberg Center at Eisenhower
Angiogenesis Foundation, Inc.
Annenberg Center at Eisenhower
Outreach Initiative: Veterinarians Speaking for Research
Americans For Medical Progress
"The Best of Antiangiogenesis": Webcast with highlights from The Judah Folkman 6th International Conference Antiangiogenesis: New Frontiers in Therapeutic Development Evolving Treatment Strategies for Chronic Immune Thrombocytopenic Purpura in the Veterans Health Administration System Evolving Treatment Strategies for Chronic Immune Thrombocytopenic Purpura in the Veterans Health Administration System
Support 2009 Educational Initiatives
2
American Social Health Association
American Veterinary Medical Association
Cervical Cancer Prevention Education Project
American Physiological Society
Webinars: 1. Prostate Cancer Prevention and 2. Understanding Risk
Support Endowment Fund for Annual Scholander Award for 2009
American Pharmacists Association
American Urological Association Education and Research
Joint Forces Pharmacy Seminar 2008, Clinical and Pharmacology Updates, Information Systems and Medication Management
American Liver Foundation
2009 American Thoracic Society Travel Scholarship Program
Think B: Hepatitis B Information You Need to Know
American Heart Association
American Thoracic Society, Inc.
The Acute Coronary Syndrome Continuum: Current and Emerging Management Strategies
American Health Resources, Inc.
Support Summer Internship in Laboratory Animal Medicine for Veterinary Students
PharmEd: Human Immunodeficiency Virus Drug Therapy Update for the Pharmacist
American Diabetes Association
American Society of Laboratory Animal Practitioners
American Diabetes Association 68th Scientific Sessions: Scientific Highlights
American College of Laboratory Animal Medicine
American Society of Hypertension
Support the American College of Laboratory Animal Medicine Forum Innovation in Laboratory Animal Management & Medicine
Advances in the Management of Postoperative Ileus: Reducing the Clinical and Economic Burden
Education Symposia Programs at the 2008 Annual Meeting.
American College of Gastroenterology
Symposia and Enduring Material Beta Blockers and Hypertension in 2008: Differentiating Mechanisms and Addressing the Evidence
$11,400
Similarities and Differences in Asthma and Chronic Obstructive Pulmonary Disease
American College of Chest Physicians
American Society of Health System Pharmacists
$35,000
Chronic Obstructive Pulmonary Disease: 2009
American College of Chest Physicians
$110,000
$10,000
$42,951
$121,697
$25,000
$85,500
$19,000
$17,130
$25,000
$7,600
$22,617
$231,150
$45,000
$1,000
$4,500
$50,000
$50,753
$4,400
$26,000
$21,018
$42,036
$172,633
Chronic Obstructive Pulmonary Disease Patient Management: A Comprehensive Approach
American College of Chest Physicians
$112,104
Amount
American College of Chest Physicians
Project Description
Page 446
CHEST 2008 Educational Symposium Prophylaxis of Venous Thromboembolism in the Medical Patient: The Good, the Bad, and the Ugly
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
30th Anniversary Celebration (Breast Cancer) Can't Catch Your Breath? Come Get Tested Asthma Grand Rounds at Partners Asthma Center Partners Asthma Center's Quarterly Patient Newsletter: Breath of Fresh Air Immunization Advocacy and Education 15th Annual Clinical Management of Heart Disease: Cardiology Update 2008 Lymphatic Filariasis Elimination Activities Improving Healthcare Quality in Chronic Care 2008 Breakthrough Ball Sponsor
Boys & Girls Clubs of Greater Washington
Breast Cancer Network of Strength
Breathe New Hampshire
Brigham & Women's Hospital, Inc.
Brigham & Women's Hospital, Inc.
California Coalition for Childhood Immunization
Cardiovascular Institute of Philadelphia
Carter Center
Center for Health Care Strategies
Children's Cancer And Blood Foundation
3
FitU and FitFamily Program
Board of Trustees of the University of Illinois
Annual Physician and Surgeon Convention of PR College Contribution for 14th Annual Meeting Nov 13-15, 2008 A Chocolate Affair for Cancer Support Programs Chronic Obstructive Pulmonary Disease Management: State of the Art Support the Funding for the Annual Laboratory Animal Science and Technology Seminar Chronic Obstructive Pulmonary Disease: Improving Treatment, Maximizing Benefit Diagnosing and Treating Co Morbidities in Patients with Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome Discovery Health Channel Multiplatform--Migraine: Relieving the Burden
Colegio de Medicos Cirujanos de Puerto Rico, Inc.
Connective Tissue Oncology Society
Cornucopia House
Danbury Hospital
Delaware Valley Branch - American Association for Laboratory Animal Science
Discovery Communications, LLC
Discovery Communications, LLC
Discovery Communications, LLC
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Membership Renewal - Corporate Benefactor
Cold Spring Harbor Laboratory
Clinical Care Options
Clinical Care Options
$2,500
Committed to Caring II: African American and Latino Clinicians Responding to Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome.
Clinical Care Options Official Conference Coverage of the Forty-Eighth Annual Interscience Conference on Antimicrobial Agents and Chemotherapy/Infectious Diseases Society of America Annual Meeting Clinical Care Options Official Conference Coverage of the Twenty-Seventh International Acquired Immune Deficiency Syndrome Conference
$2,500
2009 Cardiovascular Conference: Advances in Cardiovascular Therapy
Baylor University Medical Center
$146,667
$223,050
$98,825
$1,900
$4,000
$10,000
$20,000
$5,000
$50,000
$73,064
$96,587
$15,000
$1,000
$250,000
$3,000
$20,000
$10,000
$4,000
$3,500
$1,000
$400,000
$1,500
The 3rd Annual Cardiovascular Nursing Symposium
Atlanticare Regional Medical Center
$95,000
Amount
Understanding and Treating Menstrual Migraine
Project Description
Page 447
Association of Reproductive Health Professionals
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Understanding Rotavirus Vaccination
Discovery Communications, LLC
Hepatology Fellowship for 7/1/08-12/31/08 Movement Disorders Program Newsletter Early Detection of Breast Cancer in Young, Low-Income African American Women Healthy Lifestyles (Obesity) Program Expansion Donation to the 47th Annual Meeting 4th Annual Georgetown Breast Cancer Update: Emerging Trends in the Management of Breast Cancer Advancing Treatment Paradigms in Hematologic Malignancies: Highlights from the 50th American Society of Hematology Annual Meeting OncoBeat American Society of Hematology: Reporting the News…Beating Cancer, St. Vincent's 6th Annual Indy Hematology Review Mujer Sana - Latina Cervical and Breast Cancer Early Detection Program General Support for the Organization's Mission Support new programs in 2009 - Educating the Public about the Essential Role of Laboratory Animals to Advance Human Health Update in the Management of Asthma Support Symposium - Cancer, Prevention and Detection Research Breast Health Outreach and Counseling Program GSK Research & Education Foundation for Cardiovascular Disease Award Program for Young Investigators Award Winner 2009 Update in Oncology 2009 Annual Winter Continuing Medical Education Conference Support 2009 Cell Biology of Megakaryocytic and Platelets
Duke University
Duke University
Duke University Medical Center
Duke University Medical Center
Eastern Pharmaceutical Technology
Educational Concepts Group LLC
Educational Concepts Group LLC
Educational Concepts Group LLC
Educational Concepts Group LLC
El Pueblo
Epilepsy Foundation of America
Foundation for Biomedical Research
Franklin Square Hospital, Inc.
Friends of Cancer Research
Fund for Philadelphia
General Hospital Corporation
Genesys Regional Medical Center
Georgia Association of Physician Assistants, Inc.
Gordon Research Conferences
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Antithrombotics in Acute Coronary Syndrome
Duke University
Discovery Institute of Medical Education (DIME)
Discovery Institute of Medical Education (DIME)
Understanding Rotavirus Vaccination
Discovery Communications, LLC
American Society of Health-System Pharmacists Symposia: Integrating Treatment Guidelines for Acute Coronary Syndrome into Clinical Practice: Antiplatelet and Anticoagulant Therapies The New Anticoagulant Array for the Acute Coronary Syndromes: Differentiating Agents in the Latest Guidelines to Simplify Selection
Discovery Health Channel Multiplatform--Migraine: Relieving the Burden
Project Description
Discovery Communications, LLC
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
4
$10,000
$20,000
$3,000
$55,000
$100,000
$75,000
$2,100
$55,500
$275,000
$75,000
$10,000
$15,000
$5,000
$10,000
$500
$25,000
$25,000
$3,000
$28,448
$17,500
$33,185
$186,180
$44,825
$50,000
$146,666
Amount
Page 448
5
Cervical Cancer Patient Education Web Site Initiative
Gynecologic Cancer Foundation
$6,600
$3,000 $3,800
Best of the Day from the 2008 San Antonio Breast Cancer Symposium Lymphoma & Myeloma 2008 Overcoming Rituximab Resistance: Satellite Symposium at Lymphoma & Myeloma 2008 Annual Interscience Conference on Antimicrobial Agents and Chemotherapy/Infectious Diseases Society of America forty-sixth Annual Meeting Human Immunodeficiency Virus Business Reception Understanding Immune Thrombocytopenic Purpura Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome Advanced Clinical Update: 2008 Medical/Surgical Treatment of Deep Vein Thrombosis / Pulmonary Embolism Support 2009 programs Understanding What Is New About Hepatitis One Year Subscription - This is the First of a Three Year Sponsorship Clinical Dilemmas in the Treatment of Venous Thromboembolism Improving the Management of Human Immunodeficiency Virus Disease: An Advanced Course in Human Immunodeficiency Virus Pathogenesis, Antiretrovirals, and Other Selected Issues Bronze Sponsorship International Humanitarian Relief Recent Advances in Pulmonary and Critical Care Medicine Support Lectures on Key Topics in the Field of Humane Science and Methods in Research Spearheading the Development of Alternatives
Imedex
Imedex
Imedex
Infectious Diseases Society of America Research and Education Foundation
Information Television Network
Inova Health System Foundation
Inova Health System Foundation
Institute for Laboratory Animal Research
Institute for Professional Development in the Addictions
Institute of Medicine of the National Academies
Integris Baptist Medical Center
International Acquired Immune Deficiency Syndrome Society - USA
International Gynecologic Cancer Society
Intervol
John Butler Lung Foundation
John Hopkins University - Center for Alternative to Animal Testing
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
$1,800
A Roundtable Exploration of Best Practices & Updates in Immunization
Illinois Pharmacists Association
$1,000
$15,000
$85,000
$100,000
$85,500
$10,000
$1,500
$130,000
$7,500
$52,568
$30,000
$10,000
$5,000
$8,000
Seventh Annual Convention and Scientific Meeting
HIV Treaters Medical Association of Puerto Rico, Inc.
$2,000
26th Annual DHMC Cardiovascular Disease Update Symposium 2008
$15,440
$105,712
$50,000
Hitchcock Medical Center
Health Science Center
Haymarket Medical Education
African American Women Living Healthy
Gynecologic Cancer Foundation
Satellite Symposium and Enduring Material at American Academy of Physician Assistants (AAPA) Congress "Dyslipidemia: The Rest of the Story" 2008 Community Pharmacist Continuing Education Program: Achieving Glycemic Control in Type II Diabetes: Where Are We in 2008?
$3,500
Grand Rapids Area Medical Education Center
$40,000
$3,000
Grand Rapids Clinical Oncology Program’s 13th Annual Distinguished Lecture Series “Oncology Research Update 2008”
Amount
Asthma Crisis 2008: Ethnic Disparities, National Guidelines, and Community Based Strategies
Project Description
Page 449
Grand Rapids Area Medical Education Center
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Cardiovascular Topics at Johns Hopkins Support 2009 Meeting Season - Director's Fund 2008 Kidney Cancer Association Annual Meeting Melanoma Grand Rounds Charitable Donation Support Their Mission: Providing Patient Support and Advocacy for Patients Living with or at Risk of the Disease 2008 Forum for Discovery Life without Lupus Gala 2008 2008 North American Educational Forum on Lymphoma March of Dimes Great Chefs of the Triangle Sponsorship 13th Annual Massachusetts Immunization Action Partnership: Skills Building Conference Maternal and Child Health Programs Maternal and Child Health Programs Hematology/Oncology Department Briefings: Update in the Treatment of Immune Thrombocytopenic Purpura Managing Triglycerides: A Crucial Component of Cardiovascular Risk Reduction Key Concepts for Unlocking the Door to Detection and Management of Genital Herpes Updates in Hypertension Updates in Type 2 Diabetes Grand Rounds: Hormones and Headache 2008 San Antonio Breast Cancer Update Managing the Patient with Potential Genital Herpes and Human Immunodeficiency Virus Coinfection Not So Uncomplicated: Issues in the Treatment of Impetigo in the Age of Antibacterial Resistance Prostate Cancer Awareness in Primary Care: Dilemmas and Opportunities
Johns Hopkins University
Johns Hopkins University
Keystone Symposia
Kidney Cancer Foundation
Little Falls Hospital
Long Island Association for Acquired Immune Deficiency Syndrome Care
Lung Cancer Alliance
Lupus Research Institute Incorporated
Lupus Research Institute Incorporated
Lymphoma Research Foundation
March Of Dimes Birth Defects National Foundation
Massachusetts Chapter of The American Academy of Pediatrics
Maternity Care Coalition
Maternity Care Coalition
McMaster University Ontario
Med Institute
Med Institute, LLC
Med Institute, LLC
Med Institute, LLC
Medical College of Ohio at Toledo Foundation
Medical Society of Delaware
Medscape
Medscape
Medscape
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
A Comprehensive Review of the Recommendations for Vaccination in Infants, Children, Adolescents, and Adults
Johns Hopkins University
Project Description 10th Annual Human Immunodeficiency Virus Update for The Johns Hopkins Acquired Immune Deficiency Syndrome Service County Program Nurses and Case Managers
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
6
$22,875
$19,750
$18,000
$3,000
$2,500
$60,000
$60,000
$60,000
$72,805
$155,750
$1,000
$1,000
$3,500
$5,000
$10,000
$15,000
$25,000
$50,000
$5,000
$1,850
$82,500
$25,000
$5,000
$97,310
$2,850
Amount
Page 450
6th Annual World Congress on the Insulin Resistance Syndrome Colon and Rectal Surgery: PrIncorporatediples and Practice Course 2008 Fall 2008 Chronic Obstructive Pulmonary Disease Program Clinical Case Reviews in Migraine Management Diagnosis; Acute Management; Prevention; Comorbid Depression & Anxiety Innovative Cancer Therapy for Tomorrow: Chemotherapy Foundation Symposium XXVI New Drug Update Anticoagulation Update National Acquired Immune Deficiency Syndrome Treatment Advocacy Project Treatment Education Program Membership Dues for 2009 Chronic Obstructive Pulmonary Disease: Enhancing Recognition and Improving Outcomes Dinner Under the Desert Sky Update on the Drug Therapy Management of Allergic Rhinitis Renewal of Annual Membership 31st Annual Pulmonary and Allergy Update at Keystone Making the Right Diagnosis: The Need for Spirometry
Metabolic Endocrine Education Foundation
Minnesota Colon and Rectal Foundation
Minnesota Pharmacists Association
Montefiore Medical Center
Mount Sinai School of Medicine of New York University
Mountain Area Health Education Center, Inc.
Naples Community Hospital, Inc.
National Acquired Immune Deficiency Syndrome Treatment Advocacy Project
National Association for Biomedical Research
National Association for Continuing Education
National Association of Boards of Pharmacy
National Community Pharmacists Association
National Institute of Statistical Sciences
National Jewish Medical and Research Center
National Jewish Medical and Research Center
Heparin Induced Thrombocytopenia Grand Rounds Series Prostate Cancer: Keeping Abreast of the Current Concepts and Latest Advances" CME Grand Rounds Program Allergy Nurses Course New Orleans Acquired Immune Deficiency Syndrome Task Force Twenty-Fifth Anniversary Campaign Monthly Educational Symposia
Network for Continuing Medical Education
Network for Continuing Medical Education
New England Society of Allergy Nurses
New Orleans Acquired Immune Deficiency Syndrome Task Force
New York County Medical Society
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Donation in Memory of Carol R. Dewalt
National Multiple Sclerosis Society
National Lipid Association
National Lipid Association
Triglycerides in Cardiovascular Disease Risk Management
Medscape
National Lipid Association Satellite Symposium, Monograph and Web Activity "Dyslipidemia: Assessing Coronary Risk Factors in the Lipid Profile to Optimize Intervention" National Lipid Association Satellite Symposium, Monograph and Web Activity "Dyslipidemia: Assessing Coronary Risk Factors in the Lipid Profile to Optimize Intervention"
Triglycerides in Cardiovascular Disease Risk Management
Project Description
Medscape
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
7
$9,500
$35,000
$5,000
$23,574
$59,776
$100
$31,650
$94,958
$250,000
$25,000
$10,000
$77,508
$5,000
$100,000
$30,000
$120,000
$9,350
$1,650
$22,500
$20,000
$4,000
$5,500
$20,000
$77,000
$231,000
Amount
Page 451
Best Practices for the Management of Human Immunodeficiency Virus Associated Neurocognitive Disorders Patient Centered Approaches to the Management of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome: An Update on the Safety, Efficacy, and Dosing of Protease Inhibitors Annual Institutional Membership Dues North Carolina Chapter/American College of Physicians 2009 Scientific Session 2009 Annual Meeting Support Two Yearly Meetings in 2009 Graduate Traineeship 5/16/08-12/15/08 Installment Payment Graduate Traineeship 8/15/08-8/15/09 Installment Payment Graduate Traineeship 5/16/08-12/15/08 Installment Payment Graduate Traineeship 8/16/08-10/15/08 Installment Payment Graduate Traineeship 5/16/08-12/15/08 Installment Payment Graduate Traineeship 5/16/08-12/15/08 Installment Payment Graduate Traineeship 8/15/08-8/15/09 Installment Payment Support Logic and Cognitive Science Lecture and Undergraduate Internship
North American Center for Continuing Medical Education, LLC
North American Center for Continuing Medical Education, LLC
North Carolina Association for Biomedical Research
North Carolina Chapter, American College of Physicians
North Carolina Neurological Society
North Carolina Regional Chapter of the Society of Toxicology
North Carolina State University
North Carolina State University
North Carolina State University
North Carolina State University
North Carolina State University
North Carolina State University
North Carolina State University
North Carolina State University - College of Humanities & Social Sciences
8
$190,710
Changing Concepts in the Management of Human Immunodeficiency Virus Disease 2009
New York University
26th Annual Infectious Disease Seminar for the Practicing Physician 2008 GSK Chemistry Scholar Award Lynn Sage Breast Symposium Lynn Sage Symposium: Targeted Therapies: Manipulating the Biology of Breast Cancer The 45th Annual Year in Internal Medicine Conference
Northeastern Ohio Universities College of Medicine
Northwestern University
Northwestern University
Northwestern University
Northwestern University
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
2009 North Carolina Veterinary Conference Sponsorship - Support 14th Annual Conference
North Carolina Veterinary Conference
North Carolina State University Physical & Mathematical Sciences Foundation, Inc Graduate Program Support
$309,500
2008 Annual Conference
New York State Society of Physician Assistants Inc.
$5,000
$44,000
$41,250
$20,000
$3,000
$4,750
$103,950
$20,000
$3,660
$3,660
$3,660
$3,720
$3,615
$3,615
$7,230
$1,000
$5,000
$3,000
$57,000
$45,000
$5,000
$5,000
New York State Society of Physician Assistants 2008 Annual Continuing Medical Education Conference
New York State Society of Physician Assistants Inc
$2,000
Amount
Advances in Medical and Interventional Treatments for Chronic Obstructive Pulmonary Disease
Project Description
Page 452
New York Medical College
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Red Tie Night 2009 Educating Your Patient: Herpes Simplex Virus Testing, Counseling & Treatment Eliminating the Transmission of Hepatitis A and B through Vaccination: Women s Health Annual Visit 2008 Diabetes and Endocrine Update 2009 Critical Care Update Parkinson Action Network: 15th Annual Morris K. Udall Awards Dinner Parkinson s Unity Walk 2008 Membership Patient Advocate Foundation Co-Pay Relief Program Autoimmune Disease Silo Grand Rounds: Managing Difficult to Manage Asthma Support Educational Initiatives - Training, Education and Programs Support Educational Programs and Initiatives Pharmacy Based Immunization Delivery Joint National Committee 8 Impact: New Approaches to Cardiovascular Risk Reduction Donation in Memory of Margaret Himes Continuing Medical Education Paper Symposium on Secondary Immune Thrombocytopenic Purpura: Seminars in Hematology Immune Thrombocytopenic Purpura Online Monograph Series 7th Annual Future of Breast Cancer Congress Controversies in Breast Cancer, Adjuvant and Neoadjuvant Therapy Evolution in ErbB2 Targeted Therapeutics for Breast Cancer Integrated Curriculum in Chronic Lymphocytic Leukemia 2009 Oncology Best Practices Advances in Breast Cancer Oncology Dialogue on Evolving Standards of Care for Chronic Lymphocytic Leukemia: OncoLogue Online Breast Cancer Curriculum
Oklahoma Acquired Immune Deficiency Syndrome Care Fund
Omnia
Omnia
Park Nicollet Institute
Park Nicollet Institute
Parkinson's Action Network Foundation
Parkinson's Unity Walk, Inc.
Partnership for Quality Medical Donations
Patient Advocate Foundation, Inc.
Pennsylvania Hospital
Pennsylvania Society for Biomedical Research
Pennsylvania Veterinary Medical Association
Pharmacists Society of the State of New York
Philadelphia Health and Educational Corp,
Phoenixville Hospital Cancer Center
Physicians Academy for Clinical and Management Excellence
Physicians Academy for Clinical and Management Excellence
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Physicians Education Resource Group LP
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
"Obesity: Fundamentals and Frontiers" Continuing Medical Education
Project Description
NYU Post-Graduate Medical School
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
9
$15,000
$25,000
$272,000
$300,000
$146,144
$96,250
$7,500
$122,250
$30,645
$100
$5,000
$5,000
$7,600
$57,000
$1,650
$200,000
$15,000
$5,000
$10,000
$1,500
$1,500
$102,000
$149,250
$5,000
$25,000
Amount
Page 453
2008 Fall Seminar: Management of the Allergic Asthma Patient Street Medicine Institute, Symposia and New Programs 2008 Cutting Edge of Sleep Conference: New Research; New Directions
Physicians Education Resource Group, LP
Piedmont Association of Physician Assistants
Pittsburgh Mercy Foundation
Postgraduate Institute for Medicine
10
Emerging Pathways with Therapeutic Potential in Cancer
Physicians Education Resource Group, LP
Fifty-Ninth Annual Meeting of the PR Urological Association Patient Education Program 6th Annual Contemporary Issues in Multidisciplinary Breast Cancer Management Update in Pulmonary & Critical Care Medicine Third Annual Advances in Sleep Medicine Improving Deep Vein Thrombosis Prevention and Detection in High Risk Specialties 2008 Breast Cancer Update: An Audio Review Journal for Medical Oncologists
ProCom
Puerto Rico Urological Association, Inc.
Pulmonary Hypertension Association, Inc.
Regents of the University of Michigan
Regents of the University of Michigan
Regents University of California Los Angeles
Research Institute for Texas Health Resources
Research to Practice
Respiratory Rally
Respiratory Health Association of Metropolitan Chicago
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Visiting Professors: Clinical Investigators Visit the Clinics of Practicing Oncologists
Research to Practice
Research to Practice
Research to Practice
Research to Practice
Continuing Medical Education Dinner Meetings in Type 2 Diabetes Mellitus
ProCom
Breast Cancer Update Journal Club: A Multidisciplinary Review of New Data Presented at the 2008 San Antonio Breast Cancer Symposium and in Other Recent Peer Reviewed Publications Cancer Conference Update: An Audio/Podcast Review of Key Presentations and Posters from the 2008 American Society of Hematology Annual Meeting Hematologic Oncology Update 2009 Edition: An Audio Review Journal for Medical Oncologists and Hematologists
$15,000
American Diabetes Association Navigating the Storm: Debating Effective Treatment Plans with Oral Agents for Diabetes
$5,000
$62,837
$75,000
$12,500
$25,000
$43,899
$34,104
$5,000
$3,000
$3,000
$15,000
$10,000
$192,724
$64,419
2008 Pri-Med Meeting: Benefit to Risk Ratios for Treatments of Type 2 Diabetes
$123,816
$40,000
$15,000
$350,000
$2,000
$125,000
ProCom
Postgraduate Institute for Medicine
Postgraduate Institute for Medicine
$20,000
Conversations with the Experts: A Discussion on New Data and Highlights from the 2008 American Society of Hematology Meeting
Clinical Care Options Independent Conference Coverage of the 2008 Annual Meeting of the American Society of Hematology Treatment of Thrombocytopenia in Patients With Chronic Hepatitis C: Potential Impact on Treatment Candidacy and Outcomes
$53,282
Receptor Based Therapeutics: An Interactive Expose
Physicians Education Resource Group LP
$27,050
Progress in Antiangiogenic Therapies for Kidney Cancer
Physicians Education Resource Group LP
$15,381
Amount
Online Hematologic Malignancies Core Curriculum
Project Description
Page 454
Physicians Education Resource Group LP
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
35th Annual Meeting for the Society for Pediatric Dermatology 2009 Society of Toxicology Affiliates Dues Diamond Sponsorship Corporate Sponsorship Program for 2008-2009 Breath of Life Ball Acute Coronary Syndrome Support 2009 programs including SUBR Excellence in Biomedical Research Award Cardiology Millennium Conference LF Support Centre at Noguchi Mectizan Donation Program Acute Coronary Syndrome Neurology Update I: Headache 8th Annual Multidisciplinary Genitourinary Oncology Course
Society for Pediatric Dermatology
Society of Toxicology
Society of Toxicology
Society of Toxicology Mid-Atlantic Chapter
Southern California Chapter
St Joseph's Hospital and Medical Center
States United for Biomedical Research
SwedishAmerican Hospital
Task Force For Child Survival And Development
Task Force For Child Survival And Development
Temple University
The American Academy of Neurology
The Cleveland Clinic Educational Foundation
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
21st Annual Pre American Academy of Dermatology Meeting of the Society for Pediatric Dermatology
SciMed
SciMed
SciMed
SciMed
Society for Pediatric Dermatology
Sponsor Scientists Center for Animal Welfare Meetings and Sessions for 2009
Scientists Center for Animal Welfare
SPED Convention and Post Graduate Diabetes Course
Optimizing Care Delivery to Patients with Primary or Secondary Immune Thrombocytopenic Purpura
Scienta
Sociedad Puertoriqueña de Endocrinologia y Diabetologia, Inc.
Optimal Management of Asthma: Using the Right Tools
Scienta
SciMed
Key Concepts for Unlocking the Door to Detection and Management of Genital Herpes
Scienta
A Contemporary Issue in Clinical Medicine: Reducing Risk of Coronary Heart Disease in Patients with Hypertriglyceridemia Associated Mixed Dyslipidemia A Contemporary Issue in Clinical Medicine: Reducing Risk of Coronary Heart Disease in Patients with Hypertriglyceridemia Associated Mixed Dyslipidemia Fish Derived Omega 3 Fatty Acids: The Role of Eicosapentaenoic (EPA) and Docosahexaenoic (DHA) in Human Health Maintaining Cardiovascular Health in Patients with Mixed Dyslipidemia: Optimizing the Management of Hypertriglyceridemia and Non HDL Cholesterol Reducing Cardiovascular Risk in Patients with Mixed Dyslipidemias: Effective Management of Triglycerides and Non High Density Lipoprotein Cholesterol
Nevada Immunization Coalitions Immunization Advocacy Nevada Vaccines For Children Only Transition
Project Description
Saint Mary's Foundation
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
11
$2,500
$10,000
$2,500
$272,884
$76,000
$3,000
$4,750
$3,150
$3,000
$1,000
$12,000
$2,500
$5,000
$2,500
$5,000
$51,972
$133,606
$35,755
$33,067
$196,248
$10,000
$46,647
$231,626
$14,754
$10,000
Amount
Page 455
$349,851 $116,675
Achieving Effective Breast Cancer Management: Individual Patient Profiles and Targeted Treatment Strategies Expert Insight on the Future of Targeted Breast Cancer Therapy Heparin Induced Thrombocytopenia 2008 Clinical Curriculum Initiative Immune Thrombocytopenic Purpura 2008 Clinical Curriculum Initiative Implementing a Multimodal Management Strategy for Postoperative Ileus: Clinical Assessment, Monitoring, and Treatment Support for the Nursing Community Phase I of the 2009 Venous Thrombosis Embolism Curriculum: Inter Disciplinary Hospital Grand Rounds Pri Med Updates: Revisiting the Role of Beta Blockers in the Management of Hypertension A Closer Look at Complicated Cases The Breast Cancer Clinical Companion: A Summation of Clinical Evidence from 2007 Highlights of American Society of Hematology 2008 Highlights of American Society of Hematology 2008 2008 Columbus Diabetes University Dermatology Grand Rounds Neurology Grand Rounds: Outpatient Management of Headache Patients at Risk for Venous Thromboembolism: Exploring Options for Safe and Effective Prophylaxis Satellite Symposium Held in Conjunction with Annual Scientific Meeting Meeting the Joint Commission on the Accreditation of Healthcare Organizations Anticoagulation Patient Safety Goals: Case Studies and Local Experience Have Your Voice Heard by Officials and Providers Sponsor the UCLA/TORI Oncology Network Research Conference Substance Abuse Treatment and Prevention Research Programs The Evolution of Personalized Medicine in Breast Cancer Diagnosis and Treatment Diagnosis, Prevention and Treatment of Migraine and Bipolar Disorder
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The France Foundation
The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society
The Medical Center, Inc.
The Pennsylvania State University
The Pennsylvania State University
The Physicians Academy for Clinical and Management Excellence
The University of Arizona Foundation
The University of Connecticut School of Pharmacy
Together Incorporated
Translational Oncology Research International
Treatment Research Institute
Trinitas Hospital
Trustees of Columbia University in the City of New York
12
$19,769
2008 Heparin Induced Thrombocytopenia Continuing Education Initiative / American Association of Critical Care Nurses Symposium
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
$35,000
Tenth Antiepileptic Drug Trials
The Epilepsy Study Consortium, Inc.
$46,190
$3,000
$1,000
$10,000
$5,000
$3,000
$19,952
$382,455
$3,550
$5,000
$5,000
$5,000
$5,000
$5,000
$31,753
$152,230
$197,308
$5,000
$5,000
$10,000
Cleveland Clinic Epilepsy Symposia 2009
The Cleveland Clinic Educational Foundation
$5,000
Amount
American Society of Hematology Review
Project Description
Page 456
The Cleveland Clinic Educational Foundation
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Coverage of Immune Thrombocytopenic Purpura at the American Society of Hematology: 50th Annual Meeting Neurology Symposium: Essentials for Your Practice Neurology Update 2008 2008 GSK Chemistry Scholar Award
Trustees of the University of Pennsylvania
University Hospital
University of Arkansas for Medical Sciences
University of California Berkeley
Reclaiming Control: Life After Breast Cancer 12th Annual Cincinnati Comprehensive Breast Cancer Conference Clinical Challenges in Epilepsy Care: A Case Based Approach Advances in Epilepsy Management: Challenging Issues and Challenging Populations Medical Grand Rounds General Internal Medicine 2008 Practicing Clinicians Exchange: Stemming the Tide: Timely Intervention to Halt Migraine Progression Graduate Traineeship 5/16/08-5/15/09 Installment Payment Graduate Traineeship 5/16/08-5/15/09 Installment Payment Graduate Traineeship 5/16/08-5/15/09 Installment Payment Graduate Traineeship 5/16/08-5/15/09 Installment Payment Scholarship Award Oncology Fellowship 7/1/08-12/31/08 Support Spring and Fall 2009 Seminar Series on Analytical Chemistry Drug Development Fellowship
University of California San Francisco
University of Cincinnati
University of Florida
University of Maryland School of Medicine
University of Medicine and Dentistry of New Jersey
University of Nebraska Medical Center
University of North Carolina
University of North Carolina
University of North Carolina
University of North Carolina
University of North Carolina at Chapel Hill
University of North Carolina at Chapel Hill
University of North Carolina at Chapel Hill
University of North Carolina at Chapel Hill School of Pharmacy
13
The Medical Management of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome
University of California San Francisco
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
University of North Carolina at Chapel Hill School of Pharmacy Alumni Association University of North Carolina Pharmacy Alumni Association Golf Tournament
$2,500
Support 2009 Workshop Symposium Focused on Innovative and Recent Developments in Technology for Production of Membrane Proteins
$5,000
$50,473
$5,000
$1,000
$28,447
$3,024
$3,024
$3,024
$3,024
$93,750
$1,420
$5,000
$3,000
$2,500
$7,500
$2,500
25th Symposium: Cardiology for the Practitioner
$192,927
$10,000
$20,000
$3,000
$2,500
$45,000
$5,000
$127,028
Amount
Page 457
University of California San Francisco
University of California Regents
University of California Regents
6th Annual New Insights Into Coagulation
Trustees of the University of Pennsylvania
9th Annual University of California San Diego Heart Failure and Hypertension Symposium for Primary Care and Internal Medicine Physicians What to Add After Metformin: Individualized, Effective and Safe Clinical Strategies for Durable Glycemic Control in Patients with Type 2 Diabetes
2008 Executive Management Program for Pharmacy Leaders
Project Description
Trustees of the University of Pennsylvania
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Immunization Update: 2009 Urologic Oncology: Advances in Clinical Practice
University of Southern Nevada
University of Texas System
Vanderbilt Ingram Cancer Center 2nd Annual American Society of Hematology Review Symposium GSK Research & Education Foundation for Cardiovascular Disease Award Program for Young Investigators Award Winner 11th Annual Diabetes Management Conference Advances in Diagnosis and Treatment of Hematologic Malignancies Familial Gastrointestinal Cancer Syndromes: Genetics, Diagnosis, Management and Future Directions Improved Immunization Compliance Summer 2008 Internship 47th Annual Scientific Session Little Bites, Big Steps: Early Childhood Nutrition and Fitness Program Wisconsin Northwood Family Practice Update Fall 2008 Conference Calomiris Health and Fitness Program
Vanderbilt University
Vanderbilt University Medical Center
Wake Forest University Health Sciences
Washington University
Washington University
Wayne State University
West Chester University of Pennsylvania
Western Society of Allergy and Immunology
WHYY
Wisconsin Association of Osteopathic Physicians and Surgeons
Young Mens Christian Association of Metropolitan Washington
Source: Retrieved October 25, 2009, from http://us.gsk.com/docs-pdf/responsibility/gsk-grants-4q2008.pdf
February, 2009
Kay Yow/WBCA Cancer Fund Infrastructure Support
V Foundation
University of Wisconsin System
University of Washington
The 47th Annual University of Southern California Weil Symposium on Critical Care and Emergency Medicine
University of Southern California
The ACCORD Trial: What Did We Learn About Glucose Control in Type 2 Diabetes Related to Total Mortality and Macro Vascular Cardiovascular Disease Events? PeerView Multi Supported in Review, “Human Immunodeficiency Virus, Aging, and Chronic Comorbidities” (PA04830FC)
Educating Physicians in Their Communities: Immunization Program
Project Description
University of Pittsburgh Office of the Comptroller
Organization Name
4th Quarter 2008
Grants & Charitable Contributions to US Based Healthcare Organizations
Appendix K: GSK Public Relation Tactics 5 & 6 (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
14
$1,000
$2,000
$10,000
$30,000
$540
$20,000
$5,000
$2,500
$3,000
$55,000
$7,500
$100,000
$8,000
$1,255
$2,500
$2,500
$3,000
$12,000
Amount
Page 458
Strategy:
Key Public:
Consumers & Prospects
*Based off 30 second TV ad production expenses. Retrieved October 19, 2009, www.gaebler.com/Television-Advertising-Costs.htm
Evaluation: Consumer Surveys, Target 90% Awareness of GSK Consumer price reductions Evaluation: Reduction in operating and inventory expenses by 7%, of which a 5% in product pricing will be reduced by 5% across all product lines.
Promotional Items: Desktop Toys with Kaizen & Five S Logo, to remind Employees daily of lean business processes
0 na
1 12
60,000
10
na
0
Perpetual
10
300
120
Perpetual
Feb
Perpetual
1
Jan
120,000
4
20,000
Advertising: Posters for Promoting Lean Business Processes, to be display in conspicuous locations within all work areas
Communication: Internal E-mail blast reminders of Kaizen and Five S., 1 Communication per quarter. Training: Kaizen & Five S Certification and Training for all GSK Employees Press Releases: Announce Lean Program focused on achieving 5% in consumer price reductions Press Releases: Announce 7% Price Reduction to Consumers and Prospects
Qnty
Tactics
Corporate-wide cost reduction programs such as leaner manufacturing processes that reduce costs and global outsourcing
na
0
10
Mar
na
0
Perpetual
10
Perpetual
1
Perpetual
Apr
na
0
10
May
na
0
Perpetual
10
Perpetual
Perpetual
June
na
0
10
1
July
na
0
Perpetual
10
Perpetual
Perpetual
Aug
na
0
10
Sept
na
0
Perpetual
100
10
Perpetual
1
Perpetual
Oct
na
0
100
10
Nov
na
1
100
10
Dec
$0
60,000.00
300.00
120.00
4.00
20,000.00
# Runs/Items
$10,000
na
1.00
Corporate-wide cost reduction programs
Grand Total Evaluation of
na
Corporate-wide cost reduction programs
Grand Total Consumer & Prospect
$2
$100
$100
$1,500
$100
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar
GlaxoSmithKline Public Relations Plan & Case Study
120,000.00
# People
BUDGET
na
na
na
na
na
na
na
# Hours/Month/Person
$10,000
$10,000
$180,165,400
$120,000
$30,000
$12,000
$180,000,000
$400
$3,000
Total Expense
Page 459
Strategy:
Key Public:
Consumers & Prospects
*Based off 30 second TV ad production expenses. Retrieved October 19, 2009, www.gaebler.com/Television-Advertising-Costs.htm
Evaluation: Consumer Surveys, Target 90% Awareness of GSK Mother, Infant and Child Prescription and Medical Care Program
Evaluation: 100,000 in offline hands-on training event attendance Evaluation: 1,000,000 in online completion of video training, determined through online registration & course data Evaluation: Training assessment with a passing sore of 80%
Press Releases: Announce 7% Price Reduction to Consumers and Prospects Preferential Pricing: Medical Products & Services for Mothers, prenatal care and infants Print: Assessments and Course Evaluation Cards Training Events: Host Event in large, easily accessible venue, where hands-on prenatal training and infant/childcare healthcare issues are presented Personnel: Event Managers, Labor Hours Personnel: Ground Logistics, Labor Hours Personnel: Creative Team, Labor Hours
Press Releases: Announce Prescription & Medical Care Program specifically designated for Mothers, prenatal care, and infants
Develop or co-found accessibility to medicine programs and other healthcare initiatives through hands-on training. Tactics Advertising: 30 second national television Ad production* Advertising: 30 seconds Air Time, National Television Communication: External E-mail blasts reminders to Patient Advocates 2x per month Event: Display, Equipment, Props, and AV Internet: Dedicated website & Program Registration Portal Internet: Development and Deployment of Internet based synchronous and asynchronous Prenatal, infant and childcare health concerns. Printing: Rx Card & Medical Printing na
10
na 1 120
1
10
Perpetual
10
na Perpetual
2
Perpetual 360
Oct
1
5 20 5
0
0
Perpetual Perpetual Perpetual
0
0
Perpetual Perpetual Perpetual
1
Perpetual
0
0
Perpetual Perpetual Perpetual
1
Perpetual
0
0
Perpetual Perpetual Perpetual
1
Perpetual
0
0
Perpetual Perpetual Perpetual
1
Perpetual
1
1
10
10
na
2
360
Sept
Perpetual
Perpetual
10
Perpetual
10
na Perpetual
2
Perpetual 360
Aug
12
1
10
10
na
2
360
July
1,000,000
Perpetual
10
Perpetual
10
na Perpetual
2
Perpetual 360
June
Perpetual
1
10
10
na
2
360
May
Perpetual
Perpetual
10
Perpetual
10
na Perpetual
2
Perpetual 360
Apr
60,000
1
10
10
na
2
360
Mar
100
10
Perpetual
10
na Perpetual
2
Perpetual 360
Feb
300
120
10
2
24
1,000,000
360
Qnty 10 4,320
Jan
0
1
100
10
10
na
2
360
Nov
1
1
100
10
10
na
2
360
Dec
12.00
1,000,000.00
60,000.00
300.00
120.00
120
1.00 1
24.00
10 4320
# Runs/Items
undetermined
1,000,000.00
# People
BUDGET
Grand Total Evaluation of Develop/co-found Accessibility to Medicines Program
1.00
1,100,000.00 $10,000
$1
12.00 1,000,000.00
$1
$2,500
$35 216.00 5 $20 216.00 20 $25 full-time emp 5 Grand Total Consumer & Prospect Develop/co-found Accessibility to Medicines Program
$10,000
$0
$2
$100
$1,500
$5
$1,500
$20,000 $20,000
$200
$350,000 $175,000
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
na
40 32 1960
na
na
na
perpetual
na
na na
# Hours/Month/Person
$1,090,000
$10,000
$550,000
$500,000
$30,000
$302,400 $138,240 $245,000 $766,110,440
$120,000
$250,000
$120,000
$30,000
$180,000
$5,000,000
$180,000
$20,000 $20,000
$4,800
$3,500,000 $756,000,000
Total Expense
Page 460
Strategy:
Key Public:
Consumers & Prospects
*Based off 30 second TV ad production expenses. Retrieved October 19, 2009, www.gaebler.com/Television-Advertising-Costs.htm
Evaluation: Reach 10,000,000,000 in viewership within 12 months contract Neilson Ratings
Evaluation: 25% of viewers should be attained through introduction of new media such as a dedicated Internet program registration portal; promotion through social media and use propaganda through You-tube. (contract Neilson Ratings)
Evaluation: 75% viewership should be achieved through traditional advertising and public relation methods including outdoor, television and radio. (contract Neilson Ratings)
Tactics Advertising: Internet Banner Ads Advertising: 30 second national television Ad production* Advertising: 30 seconds Air Time, National Television Advertising: Magazines Advertising: Newsprint Advertising: Radio Collateral: Corporate Website Collateral: Leave Behind Brochures Internet: Dedicated website & Program Registration Portal Internet: Promote Patient Programs through Social Media & Viral Marketing on 10 social media sites POS: Point of Sale Display Kiosks, distributed at local Pharmacies. Kiosk allows Mothers to register for services. Personnel: Creative Team
Mass Communication of GSK Patient Programs
Perpetual
20
Perpetual
Perpetual
perpetual
Perpetual
1000 Perpetual 360 40 20 150 Perpetual 834 Perpetual
10
834
360 40 20 150
1000
Feb
100,000
Qnty 1,000,000,000 10 4,320 480 240 1,800 1 10,000 1
Jan
834
360 40 20 150
1000
Mar
Perpetual
Perpetual
Perpetual
Perpetual
1000 Perpetual 360 40 20 150 Perpetual 834 Perpetual
Apr
833
360 40 20 150
1000
May
Perpetual
Perpetual
Perpetual
Perpetual
1000 Perpetual 360 40 20 150 Perpetual 833 Perpetual
June
833
360 40 20 150
1000
July
Perpetual
Perpetual
Perpetual
Perpetual
1000 Perpetual 360 40 20 150 Perpetual 833 Perpetual
Aug
833
360 40 20 150
1000
Sept
Perpetual
Perpetual
Perpetual
Perpetual
1000 Perpetual 360 40 20 150 Perpetual 833 Perpetual
Oct
833
360 40 20 150
1000
Nov
833
360 40 20 150
1000
Dec
50,000.00
perpetual
1,000,000,000 10 4320 480 240 1800 1 10000 1
# Runs/Items
# People
BUDGET
perpetual Grand Total Evaluation of Mass Communication of GSK Patient Programs
$5,000,000
$50 full time emp 20 Grand Total Consumer & Prospect Mass Communication of GSK Patient Programs
$7,500
$250,000
$0 $350,000 $175,000 $15,000 $10,000 $750 $30,000 $3 $20,000
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
na
1960
perpetual
perpetual na perpetual
na na na na na
# Hours/Month/Person
$5,000,000
$5,000,000
$1,960,000 $1,397,740,000
$375,000,000
$250,000
$250,000,000 $3,500,000 $756,000,000 $7,200,000 $2,400,000 $1,350,000 $30,000 $30,000 $20,000
Total Expense
Page 461
Strategy:
Key Public:
Evaluation: 75% Event Attendance, Digital Swipe Card System Evaluation: Quantity of Press Mentions Evaluation: 1,000,000 in Unique Website Visitors
Tactics Collateral: Invitations & Save the Date Reminders Collateral: Digital & Print Press Kits Collateral: Press Releases Event Collateral: Info Kits Events: Host Annual 5-Day Healthcare Summit in March Events: Venue Reservation & Expense Events: Food & Beverages Internet: Event Website Personnel: Speakers Personnel: Event Managers Personnel: Ground Logistics Personnel: Creative Team
Maintain a voice/presence in current healthcare issues through participation in industry organizations, influencing public opinion, and lobbying government leadership. Inform & motivate public of healthcare best practices/approaches
Domestic Regulators, Government, Policy Makers & Lobbyists
count 50 1,000,000
Qnty 1,000 1,000 60 1,000 1 1 1 1 10 10 40 2 0 0 0 2
500 1 20 0 0 0 0
Jan
500 0 20 0 0 0 0 Perpetual 0 0 0 2
Feb
10 10 40 2
0 0 20 1000 1 1 1
Mar
0 0 0 0 0 0 0 Perpetual 0 0 0 0
Apr
0 0 0 0
0 0 0 0 0 0 0
May
0 0 0 0 0 0 0 Perpetual 0 0 0 0
June
0 0 0 0
0 0 0 0 0 0 0
July
0 0 0 0 0 0 0 Perpetual 0 0 0 0
Aug
0 0 0 0
0 0 0 0 0 0 0
Sept
0 0 0 0 0 0 0 Perpetual 0 0 0 0
Oct
0 0 0 0
0 0 0 0 0 0 0
Nov
0 0 0 2
0 0 0 0 0 0 0
Dec
# Runs/Items
na na na na na na na na 10 10 40 2
# People
BUDGET
$20,000 1.00 na $2,500 1 $2,500 1.00 1 Grand Total, Evaluation of Voice in Healthcare Issues & Influence Policy Makers
$5 1,000.00 $3 1,000.00 $15 60.00 $10 1,000.00 $50,000 1.00 $30,000 1.00 $20,000 1.00 $10,000 1.00 $125 1.00 $35 1.00 $20 1.00 $25 1.00 Grand Total, Voice In Healthcare Issues & Influence Policy Makers
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
na na na
na na na na na na na na 40 80 80 163
# Hours/Month/Person
$20,000 $2,500 $2,500 $25,000
$5,000 $3,000 $900 $10,000 $50,000 $30,000 $20,000 $10,000 $50,000 $28,000 $64,000 $8,150 $279,050
Total Expense
Page 462
Corporate Transparency & Accessibility
GlaxoSmithKline Board of Directors, Investors & Shareholders
Evaluation: Event Attendance, Digital Swipe Card System Evaluation: Quantity of Press Mentions Evaluation: Quantity of Shareholder Video Conference Attendees Evaluation: Quantity of Online Executive Chat Participants
Tactics Advertise: Internet GSK Executive Chat Sessions through Direct Mailings Advertise: Annual May Stockholders Meeting, Newspaper WSJ (1/2 Page) Events: Host Annual May Stockholders Meeting & Reserve Venue Events: Beverages & Light Hor Devours for Annual Shareholder Meeting Host: Internet Chat Sessions with Corporate Executives Host: Live & Interactive Video Conference of Annual Shareholders Meeting Mailings: Mail notice/invitation of Annual Stockholders Meeting Press Release: Annual Share Holders Meeting Announcement Publish & Distribute: Annual Report Publish: All Corporate Gifts & Donations(To & From GSK), Website Publish & Distribute: Ballots & Proxies Personnel: Executive Chat Spokesperson Personnel: Event Manager, Annual Shareholder Meeting Personnel: Ground Logistics Personnel: Creative Team
Strategy:
Key Public:
count 50 250 50
0 1 0 0 2
0
0 0 1 0
1 3 5 750,000 1 750,000 12 2 15 2
1 1 0 Perpetual 0 1 0 0 2
1 1 0 0 1
Feb
1 0 0 0 1
Qnty 12 3 1 1 12
Jan
0 1 0 0 2
1 1 0
0
1 1 0 0 1
Mar
1 1 750,000 Perpetual 1 1 0 0 2
0
1 1 0 0 1
Apr
0 1 2 15 2
0 1 0
1
1 0 1 1 1
May
0 0 0 Perpetual 0 1 0 0 0
0
1 0 0 0 1
June
0 1 0 0 0
0 0 0
0
1 0 0 0 1
July
0 0 0 Perpetual 0 1 0 0 0
0
1 0 0 0 1
Aug
0 1 0 0 0
0 0 0
0
1 0 0 0 1
Sept
0 0 0 Perpetual 0 1 0 0 0
0
1 0 0 0 1
Oct
0 1 0 0 0
0 0 0
0
1 0 0 0 1
Nov
0 1 0 0 0
0 0 0
0
1 0 0 0 1
Dec
1.00
12.00 2.00 1.00 1.00 12.00
# Runs/Items
unlimited
750,000 na 500-1000 500-1000 1
# People
BUDGET
$20,000 1.00 $2,500 $2,500 1.00 $2,500 1.00 Grand Total, Evaluation of Corporate Transparency & Accessibility
na 1 1 1
$20,000 $2,500 $2,500 $2,500 $27,500
$1,680 $7,200 $98,000 $15,953,130
24 24 1960
na na na na
$2,250,000 $3,750 $3,750,000 $24,500 $750,000
$15,000
$9,000,000 $20,000 $20,000 $10,000 $3,000
Total Expense
Page 463
na na na 980 na
na
na na na na 2
# Hours/Month/Person
3.00 750,000 5.00 circulation 1.00 750,000 perpetual 1 750,000 cost accounted for in line item above $35 1.00 2 $20 1.00 15 $25 full time 2 Grand Total, Corporate Transparency & Accessibility
$1 $750 $5 $25 $1
$15,000
$1 $10,000 $20,000 $10,000 $125
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
Non-Governmental Organizations (NGO's) & Patient Groups
Evaluation: Measure monetary contributions Evaluation: Event Attendance, Entrance Counter & Metal Detector Evaluation: Quantity of Press Mentions Evaluation: Social Media Mentions Evaluation: Quantity of Online Executive Chat Participants
Press Release: Announcement of Event Personnel: Performing Artists Personnel: Executive Spokespersons/Event Hosts-MCs Personnel: Event Manager, Concert Logistics Personnel: Ground Logistics Personnel: GSK Creative Team
Logistics: EMS, Traffic Planning, and Entrance Safety Checks
Community and Healthcare activism and support initiatives of Strategy: NGOs and Patient Groups through monetary contributions and volunteer efforts. Tactics Advertise: Promote Concert through Internet Viral Marketing Advertise: Promote Concert through Internet Social Media Events: Host Outdoor Fund-raising Concert promoting HealthCare Reform Event: Staging, Lighting, AV and Barricade Equipment Grounds: Porta-Johns, Vending Setup, Parking Setup and Breakdown Ticketing: E-Ticket through a volunteer Ticketing Agency Host: Live & Interactive Video Conference of Annual Shareholders Meeting
Key Public:
0 0 0
donations vol. & don. vol. & don. 1
10,000,000 750,000 1,000 5,000,000 50
1,200 100 25 50 300 25
300 0
0
1
50
0
Qnty perpetual 3
Jan
300 0 Perpetual Perpetual Perpetual Perpetual
Perpetual
0
0 0 Perpetual
0
Perpetual 1
Feb
300 0
0
0 0
0
1
Mar
300 100 Perpetual Perpetual Perpetual Perpetual
Perpetual
0
0 0 Perpetual
0
Perpetual 1
Apr
1 100
1
1 1
1
0
May
June
July
Aug
Sept
Oct
Nov
Dec
# Runs/Items
# People
BUDGET
Grand Total Evaluation of Healthcare Reform Rock Concert
Grand Total, Healthcare Reform Rock Concert
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
# Hours/Month/Person
100% Volunteer Project
100% Volunteer Project
Total Expense
Page 464
Non-Governmental Organizations (NGO's) & Patient Groups
Activism and Support of NGOs & Patient Groups
41,667
42
500,000
500
1
12 10
1
120
10
11
Jan
Qnty 120 1
Evaluation: Volunteer count (Measure quantity of volunteers)10% GSK emp. Evaluation: Measure monetary contributions count Evaluation: Press Mentions 50 Evaluation: Case Studies/"My Story" Testimonials 50
Promotional Items: Develop logo and manufacture/purchase an embellishment that may be worn to display support for a given cause. Ex. Lance Armstrong, "Live Strong" arm bracelets
Personnel: Participate through Volunteerism
Leadership: Found/Develop Follow-on Patient Support Group Services Post Illnesses
Tactics Financial: Monetarily Support NGOs through Memberships & Grants Financial: United Way Corporate Matching* Leadership: Host 12 fundraising Events/telethons/encourage donations and pledges Leadership: Host Panel Discussions, Provide Venue & Event Mgmt Services
Strategy:
Key Public:
41,667
42
10
1
1
10 Perpetual
Feb
41,667
42
10
1
1
10
Mar
41,667
42
10
1
1
10 Perpetual
Apr
41,667
42
10
1
1
10
May
41,667
42
10
1
1
10 Perpetual
June
41,667
42
10
1
1
10
July
41,667
42
10
1
1
10 Perpetual
Aug
41,666
41
10
1
1
10
Sept
41,666
41
10
1
1
10 Perpetual
Oct
41,666
41
10
1
1
10
Nov
41666
41
1
1
0
10
Dec
$0
500,000.00
perpetual
120.00
12.00
11.00
120.00 perpetual
# Runs/Items
BUDGET
na
as needed
Appoint Leaders as needed
na volunteers volunteers as needed Select Panel as needed
# People
volunteer work perpetual as willing as provided perpetual as willing $ 2,500.00 perpetual 1 $30 perpetual 1 Grand Total Evaluation of Activism & Support of NGO's & Patient Groups
Grand Total, Activism & Support of NGO's & Patient Groups
volunteer work
$10,000
$20,000
$250,000
$50,000 $1,400,000
Per Unit Cost
Appendix L: Proposed GSK PR Plan Budget & Calendar (cont.)
GlaxoSmithKline Public Relations Plan & Case Study
as willing na 8 20
na
as needed
8
8
as needed
na as willing
# Hours/Month/Person
$ $ $
$125,000
na na 2,500.00 600.00 3,100.00
$11,715,000
-
$1,200,000
$240,000
$2,750,000
$6,000,000 $1,400,000
Total Expense
Page 465
GlaxoSmithKline Public Relations Plan & Case Study
Page 466
GlaxoSmithKline Public Relations Plan & Case Study
Page 467
GlaxoSmithKline Public Relations Plan & Case Study
Page 468
GlaxoSmithKline Public Relations Plan & Case Study
Page 469
GlaxoSmithKline Public Relations Plan & Case Study
Page 470
GlaxoSmithKline Public Relations Plan & Case Study
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GlaxoSmithKline Public Relations Plan & Case Study
Page 472
GlaxoSmithKline Public Relations Plan & Case Study
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GlaxoSmithKline Public Relations Plan & Case Study
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