Pharma Impacted by UN Agency's Public Health Debates

Geneva, Switzerland (May 22)-The World Health Organization’s World Health Assembly is holding its 61st annual session this week to discuss a number of public health issues, many of which are tied directly to pharmaceutical manufacturing. Approximately 193 assembly delegates attending the five-day meeting in Geneva have come together from all corners of the world to debate and, hopefully, decide on some critical action points impacting pharma, including intellectual property reform, anti-counterfeiting of drug products, pandemic influenza preparedness, and the control of noncommunicable diseases.

Below is a brief look at some of the issues on the assembly’s agenda. A follow-up report will be included in next week’s Pharmaceutical Technology e-newsletter.

• Developing countries claim that current patent laws still prevent them from getting life-saving medicines at affordable prices, despite the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement which makes allowances for developing nations to create or buy copycat versions of patented drugs. WHO has been working on the issue for some time-its most recent attempt carried out earlier this month by an intergovernmental panel that was unable to reach consensus on all points. Industry leaders, represented by the International Federation of Pharmaceutical Manufacturers and Associations, and many industrialized nations, including the United States, have argued that current intellectual property rules protect against counterfeits and offers pharmaceutical companies a return on their large investments into developing new drugs; they are leery of major patent reform. Assembly delegates are discussing how to move forward.

• In 2006, WHO launched the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) to coordinate action across and between countries to halt the production, movement, and commerce of counterfeit medical products around the globe. The taskforce incorporates, among others, representatives from national and international organizations, health professionals, enforcement authorities, and drug regulatory bodies such as the US Food and Drug Administration. The taskforce has come up with recommendations to strengthen WHO’s good distribution practices (GDP) for pharmaceutical products. GDPs are a growing concern due to recent contamination in some drug product’s supply-chains. Assembly delegates are expected to comment on IMPACT’s achievements and other anti-counterfeiting approaches.

• WHO released a global strategy document in April that outlines an action plan for controlling and preventing noncommunicable diseases. The action plan specifically calls for national governments, including the US, to incorporate more government departments and sectors-including the pharmaceutical production sector-in its approach to combating these diseases. The assembly asks governments to go beyond “health policy alone.” According to WHO, noncommunicable diseases, including cardiovascular diseases, diabetes, cancers, and chronic respiratory diseases, caused approximately 35 million deaths in 2005, or 60% of all deaths globally. This statistic is expected to increase another 17% over the next 10 years. If approved, the WHO action plan is to be rolled out over the next six years, from 2008-2013.

• Last but not least, the assembly is discussing the sharing of influenza virus information and access to vaccines. Specifically, delegates may comment on the new traceability mechanism for all influenza A (H5N1) viruses submitted to the Global Influenza Surveillance Network and other methods to best prepare for and fight the virus. Last month, Sanofi Pasteur, the vaccines division of Sanofi Aventis (Paris), received a US order for 38.5 million doses (worth $192.5 million) of vaccine against a new strain of avian influenza.