Fixed Dose Combination Conference must see FDC as key to increased ARV treatment

March 22, 2004 To: Ambassador Randall Tobias and Secretary Tommy Thompson We are writing on behalf of Médecins Sans Frontières (MSF) to seek clarification on the objectives of the Conference on Fixed-Dose Combination (FDC) Drug Products, which you initiated, that will take place on March 29-30, 2004, in Gaborone, Botswana, and to request that there be space added to the agenda for the presentation of actual field experience using FDCs, including clinical outcomes, and the identification of concrete strategies for increasing access to affordable FDCs. Space for such presentations must not be limited to the period for 'general comments' and should include representatives of non-governmental organizations and associations of people living with HIV/AIDS from the region for whom the registration fee must be waived. We would also like to see space on the agenda for promoting the development of future FDCs that are urgently needed from a medical point of view, including, for example, FDCs that can be used in both women of child-bearing age and patients co-infected with TB, as well as pediatric FDCs. The availability of FDCs of antiretrovirals (ARVs) - pills containing two or three AIDS drugs in one tablet - is a reality and has dramatically improved the ability of treatment programs in poor countries to scale up access to ARVs and to reach people in remote settings. MSF is currently providing antiretroviral therapy (ART) to more than 11,000 people living with HIV/AIDS in over 20 countries in Africa, Asia, Latin America, and Eastern Europe, and expects the total number of patients on ARVs to reach 25,000 in 25 countries by the end of 2004. Over 50% of our current patients and over 70% of those newly enrolled are starting treatment using WHO-recommended triple FDCs. Because FDCs promote adherence, decrease the risk of resistance, and facilitate stock and procurement management, they are widely recognized as being a key element in efforts to scale up ARV treatment in developing countries. They are also significantly less expensive than originator companies' products, which are not available in fixed-doses. The above-mentioned advantages of FDCs are also valid for the treatment of other diseases such as malaria and TB. FDCs are recommended in WHO treatment guidelines and several FDCs, including those from generic producers, have been certified by WHO as meeting stringent international standards for drug quality, safety and efficacy through its Prequalification Project. A recent meeting on FDCs held on December 16-18, 2003 organized by WHO, which documented some of the field experience with FDCs to date, came out in strong support of the use of FDCs and endorsed the WHO-managed UN Prequalification Project to help support the procurement of effective and safe medicines of quality. The most affordable ARVs produced today, including FDCs, are produced by generic companies based in developing countries. However recent public statements by the US administration, the initiator of this conference, regarding generic medicines seem to indicate a troubling lack of support for WHO prequalified generics, including FDCs. The U.S. Global AIDS Coordinator has made several public remarks, which question the quality of generic ARVs, undermine international quality standards set by the WHO, and infer that providers of ARV treatment in developing countries who use generics may be endangering their patients’ lives. In light of the above, we question what this meeting will add to the processes that are already underway and whether it will in any way contribute to the urgent task of expanding access to affordable essential medicines for HIV/AIDS and other illnesses. We request a response to this letter by no later than Wednesday, March 24, at 5:00pm EST. Thank you in advance for your response. Sincerely, Ellen 't Hoen, Director, MSF Campaign for Access to Essential Medicines Eric Goemaere, MD, Head of Mission, MSF South Africa Kris Torgeson, Acting Executive Director, MSF-USA