MSF is currently providing antiretroviral (ARV) therapy 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 people on ARVs in our programs to reach 25,000 in 25 countries by the end of 2004.
Although there are many challenges to scaling up AIDS treatment in resource-limited settings, MSF has some key concerns related to the President's Emergency Plan for AIDS Relief (PEPFAR) policy on procurement of medicines.
In order to ensure that efforts to expand access to treatment reach the largest number of people possible, particularly the poorest and most vulnerable in remote settings, it is critically important that the most affordable quality medicines be used, and that the most user-friendly regimens be promoted.
The long-awaited five-year U.S. global HIV/AIDS strategy released on Monday, February 23, needed to clearly articulate unambiguous support for the use of quality generic medicines including fixed-dose combinations (FDCs) of antiretrovirals - that is, pills containing two or three AIDS drugs in one tablet - to dispel doubts and uncertainties about US policies on procurement. It failed to do so.
In addition, since the release of PEPFAR, the U.S. Global AIDS Coordinator and former CEO of Eli Lilly & Co., Randall Tobias, has made several public remarks which question the quality of generic ARVs, undermine international quality standards set by the WHO, and accuse providers of ARV treatment in developing countries who use generics of endangering the lives of patients.
MSF is deeply concerned that the U.S. Administration will stand in the way of countries and programs wishing to use PEPFAR funds to purchase affordable quality medicines in general, and triple fixed-drug combinations (FDCs) in particular, despite the fact that they are generally three to five times less expensive than originator ('brand name') versions, have been certified by the World Health Organization (WHO) as meeting international standards for quality, safety, and efficacy, and are manufactured by the same pharmaceutical labs that produce hundreds of generic medicines used by Americans every day.
FDCs of ARVs are widely recognized as being a key element of efforts to scale up AIDS treatment in developing countries. Based on MSF's experience delivering ARV therapy in resource-poor settings, MSF has become a strong advocate of triple FDCs. Over 50% of our current patients and over 70% of those newly enrolled are starting treatment using WHO-recommended triple FDCs. Our clinical results thus far are excellent.
Today, WHO-recommended triple FDCs are available only from generic producers because the patents of the three individual compounds are held by three different companies. The lowest available price of WHO-prequalified triple FDCs is $140 per person per year for the combination d4T/3TC/nevirapine, which is taken in the form of one pill twice a day. Meanwhile, the lowest available price of the single products of d4T, 3TC, and nevirapine from originator producers is $562 per person per year and requires that patients take six pills per day.
In other words, purchasers of ARVs and providers of treatment have a choice: with every $500-600 they spend on ARVs, they can prolong the life of one person with HIV/AIDS by having them take six pills each day (from originator companies) - or they can prolong the life of four people with HIV/AIDS by having them take just one pill in the morning and one pill in the evening (from generic manufacturers).
The U.S. administration appears to be ignoring the fact that these new tools in the fight against HIV exist today and are being widely used in treatment programs that are saving lives. MSF is concerned that the upcoming Conference on Fixed-Dose Combination (FDC) Drug Products: Scientific and Technical Issues Related to Safety, Quality, and Effectiveness being convened by the U.S. in Gaborone, Botswana, March 29-31, 2004, will not lead to the development of useful principles to be taken into account when developing, evaluating, and considering the safety, efficacy, and quality of FDCs.
Rather, we believe it aims to undermine the integrity of the WHO's Prequalification Project and delay, block, or cast doubt upon the use of affordable generic medicines of assured quality. A similar meeting was already convened by WHO in December 2003 and the experts that participated concluded that "WHO prequalification work and standard setting are clearly endorsed by established regulators…[and] countries are encouraged to use the results of WHO prequalification to fast track registration."
There is no medical or scientific basis for the Bush Administration's attacks against WHO prequalified generic medicines, and the U.S. is isolated in its view that WHO prequalification standards are not sufficient to guide national drug regulatory authorities and purchasers in assessing drug quality, safety and efficacy. The project is supported by other United Nations agencies including UNICEF, UNAIDS, and UNFPA as well as the World Bank, the Global Fund to Fight AIDS, Tuberculosis and Malaria, the Columbia University MTCT-Plus Initiative, the Clinton Foundation, and frontline providers of treatment.
The only possible explanation for the Bush Administration's position on WHO prequalification is that it is more interested in protecting the interests of the pharmaceutical industry than it is in expanding ARV treatment to the largest number of people possible.
MSF is deeply concerned that the U.S. Administration will stand in the way of countries and programs wishing to use PEPFAR funds to purchase affordable quality medicines in general, and triple fixed-drug combinations (FDCs) in particular, despite the fact that they are generally three to five times less expensive than originator ('brand name') versions.