Short story Girl and guy were speeding over 100 mph on a motorcycle) Girl: Slow down. Im scared. Guy: No this is fun. Girl: No its not. Please, its too scary! Guy: Then tell me you love me. Girl: Fine, I love you. Slow down! Guy: Now give me a BIG hug. (Girl hugs him) Guy: Can you take my helmet off and put it on? Its bugging me. In the paper the next day: A motorcycle had crashed into a building because of break failure. Two people were on the motorcycle, but only one survived. The truth was that halfway down the road, the guy realized that his breaks broke, but he didn't want to let the girl know. Instead, he had her say she loved him, felt her hug one last time, then had her wear his helmet so she would live even though it meant he would die.
The Free Trade Area of the Americas (FTAA/ALCA) and threats to medicines access
Asia Russell •
[email protected] • Health GAP • www.healthgap.org
Enhancing intellectual property rights, regional free trade agreements and access to medicines 17 November 2003 Playa Blanca, Panama
The TRIPS Agreement: • World Trade Organization Agreement on TradeRelated Aspects of Intellectual Property Rights (1994 Uruguay Round) • Most comprehensive international agreement on intellectual property rights such as patents, copyrights, and trademarks • WTO Member States can no longer rule out granting patents in particular fields of technology, e.g. pharmaceuticals • Establishes minimum standards for protection and enforcement of IPRs that must be met by all WTO Members
Declaration on the TRIPS Agreement and Public Health
“We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.”
The Doha Declaration: Reaffirming Flexibilities in TRIPS • countries determine the grounds for granting a compulsory license, not only in cases of emergency. • countries determine for themselves what constitutes a national emergency or extreme case of urgency • The right of countries to determine norms of parallel importation in national law.
Threats to Doha and the Right to Safeguard Public Health •Pressure to relinquish use of TRIPS flexibilities through the WTO accession process, aid agreements, etc. •Provision of biased technical assistance •Deliberate US strategy to move away from multilateral agreements –The US is systematically covering the globe
Current US Bilateral & Regional Agreements
NAFTA
USCentral America
USChile
USMiddle East USMorocco US Jordan
USVietnam USSingapore
Free Trade Area of the Americas
USSouthern African Customs Union
Price comparisons: Guatemala
MSF, August 2003
US Negotiating Objectives in the FTAA, CAFTA and other FTAs •Threaten public health/access to medicines in the Americas and undermine Doha Declaration by: –Limiting circumstances under which conpulsory licenses may be issued –Private sector/NGOs eliminated from access unless the government decides otherwise –CL in response to excessive pricing would be impossible
–Extending patent terms beyond 20year TRIPS minimum –Eliminate international parallel importing –Drug regulatory authorities would grant approval only if no competing patents on file –Granting exclusive rights over pharmaceutical test data
Implementing the Doha Declaration: U.S. law • USTR negotiating objectives, U.S. Trade Act of 2002 (the “Kennedy Amendment”) – “the principle negotiating objectives of the United States regarding trade related intellectual property” include respecting “…the Declaration on the TRIPS Agreement and Public Health, adopted by the World Trade Organization at the Fourth Ministerial Conference at Doha, Qatar on November 14, 2001.”
TRIPS vs. FTAA 1.
Compulsory licenses can be issues at the discretion of individual governments
1.
Compulsory licenses can be issued for national emergencies only
2.
Compulsory licenses can be issued to NGOs and the private sector
2.
Compulsory licenses are for government use only
3.
Allows for patent terms longer than 20 years
4.
Regulatory agencies (like the FDA) take on policing responsibilities
3. 4.
Requires a patent term of 20 years Leaves patent disputes to be resolved through the judicial system
TRIPS vs. FTAA (cont’d) •
Unspecified standards for protection of test data
1.
Exclusive rights for test data for 5 years
•
Global parallel importation
2.
Regional parallel importation
•
Compulsory licenses allow for export under certain circumstances (paragraph 6)
3.
Compulsory licenses are for domestic use only
5.
Haiti would lose this extension
•
LDCs have until 2016 to protecting patents on pharmaceuticals
What’s at Stake for People Living with HIV/AIDS? Example of HIV/AIDS 1.9 million people living with HIV/AIDS in Latin America and • the Caribbean ARVs have reduced AIDSrelated deaths by more than 70% in • the US and Canada Hundreds of thousands are without access to ARVs • Recent access to generics has started to bring prices down • – Annual cost of firstline went from $1000 $5000 to $350 $690 FTAA threatens to put a stop to this dynamic of generic • competition
Recommendations There is no rational explanation for including IPRs in the FTAA IPRs should be taken out of other free trade agreements in the region CAFTA, U.S.Dominican Republic FTA Health Ministries in FTAA countries should take a proactive approach in influencing the negotiating position of Ministries of Trade, Finance, etc. WHO/PAHO should take a public position against “TRIPS plus” IPRs in CAFTA and the FTAA