Open Letter On Health Council

Comment on EU Health Council meeting, 30 November – 1st November 2009

EFPIA applauds progress on patient safety proposals but regrets delays on information for patients Brussels, 1 December 2009 Sir, EFPIA, the voice of the research-based pharmaceutical industry in Europe welcomes today’s adoption by EU Health Ministers of progress reports on some of the major legislative proposals contained in the “pharmaceutical package”. Whilst welcoming those reports on proposals to prevent counterfeit medicinal products in the legal supply chain and improving pharmacovigilance, EFPIA calls on the Health Council to show urgency on all the Commission proposals, to ensure rapid adoption of legislation which will benefit EU citizens and patients. EFPIA is pleased to see that some progress has been made, and certain measures are a positive step forward and have the potential to improve patient safety. Properly implemented, they could deliver major public health benefits. However to be truly effective, they need to be strengthened in a number of crucial areas. In particular, the anti counterfeiting proposals should ensure pack integrity from manufacturer to patient; the simplest way to achieve this would be a ban on repackaging.” We are disappointed by the Health Council’s decision to freeze the debate on the Commission’s proposal to give citizens and patients improved and equal access to information on their health and medicines. This is not in the best interest of citizens; the Commission proposal is relatively narrow in scope, leaving most of the oversight to Member States. Given the strictly defined content and delivery channels of information and the proposed stringent approval, monitoring and enforcement mechanisms, the unwillingness to discuss this constructively is disappointing. EFPIA urges the European Parliament to provide a platform for a proper debate on these proposals. They offer the potential to make patients better informed about their disease and treatment, improving compliance and outcomes to the benefit of both public health and healthcare resources. In addition to the “pharmaceutical package” measures, EFPIA welcomes the Council's adoption wide-ranging proposals to address the growing threat of antibiotic resistance. This inability to treat resistant strains of infection undermines many aspects of hospital care, threatening the future of many routine procedures. These proposals provide a first step towards building a sustainable research and development platform to address current and future medical needs for effective antibiotics.

Yours faithfully Brian AGER Director General European Federation of Pharmaceutical Industries and Associations

European Federation of Pharmaceutical Industries and Associations

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