MSF continues its strong collaborations with the WHO in a number of areas germane to this crisis in Research and Development (R&D). However, we believe that the WHO as the lead health agency needs to take further urgent action to address R&D for neglected diseases.
WHO Executive Board Members Dear Executive Board member, Médecins Sans Frontières (MSF) would like to call to your attention the following issues directly impacting access to essential medicines in developing countries. The crisis in research and development (R&D) for health tools directed at neglected diseases While today many pharmaceuticals and other health tools are available to treat, cure or contribute to the control of a host of diseases, there is a profound lack of effective, safe and affordable vaccines, drugs and diagnostic tools directed at parasitic and infectious diseases.
These neglected diseases cause high mortality and morbidity among people in the developing world - people who are largely poor and without substantial purchasing power. A paucity of vaccines and diagnostics exist for these diseases, and existing medicines are often not adapted to developing world conditions, while inevitable drug resistance means that existing medicines are less and less effective.
Because of the lack of a viable market, and because of the failure of public policy initiatives to address this market failure, there is now a near complete lack of R&D directed at new or adapted health tools for neglected diseases. For example, of the 1,393 new medicines marketed during the past 25 years, only 16 were for neglected diseases. This represents a profound shortfall in effective, safe and affordable essential medicines that are directed at neglected diseases, and is the unacceptable reality today.
Health R&D is increasingly market driven, while needs-driven R&D activity is increasingly rare. Further, for R&D directed at neglected diseases, the 10 / 90 Gap is widening. MSF continues its strong collaborations with the WHO in a number of areas germane to this crisis in R&D. For example, MSF has recently partnered with WHO/TDR around a new not-for profit initiative to develop drugs for neglected diseases (DNDi). However, we believe that the WHO as the lead health agency needs to take further urgent action to address R&D for neglected diseases.
The WHO needs to assess the deficit in R&D for neglected diseases and its causes, and determine mechanisms to engage effective needs-based R&D for these diseases. We therefore urge the Executive Board to discuss the need for global measures to ensure R&D for neglected diseases at the World Health Assembly (WHA) 2003.
Implementation of the Doha declaration on trips and public health
MSF is concerned that vital questions regarding access to medicines are left in the hands of trade negotiators at the World Trade Organisation. The implementation of the 2001 Doha Declaration on TRIPS and Public Health is endangered by recent proposals by wealthy WTO members.
MSF supports a more active role played by WHO in the WTO TRIPS negotiations. WHO should assist developing countries in their efforts to protect their population by ensuring that affordable medicines can be produced and exported to countries that need them (the Paragraph 6 issue).
This is increasingly urgent as the deadline of the TRIPS implementation fast approaches - unless something is done soon, the source of affordable generic medicines will dry up.
However, in view of the recently failed negotiations at the WTO, we recommend that the Executive Board proposes a broader discussion at the WHA in May on how the availability of and access to affordable medicines can be ensured in the future. This should include a discussion on measures to encourage technology transfer, local production and export of generic medicines.
Pre-qualification of producers of low-cost medicines
MSF applauds WHO's work on the pre-qualification of medicines, including life-saving products manufactured by generic producers. Pre-qualification supports governments and NGOs in the procurement of affordable medicines of assured quality. This information is also crucial for recipients of Global Fund money. We urge you to express support for WHO's work on pre-qualification and to make additional technical and financial resources available to enable the WHO to speed up and expand this work to include other essential medicines. We look forward to discussing the above issues with WHO Executive Board members at your earliest convenience.
Sincerely, Dr. Bernard Pécoul Director, Campaign for Access to Essential Medicines Médecins Sans Frontières (MSF)