Two Doctors’ Groups Refute Analysis That Said Patents Not a Barrier to HIV/AIDS Therapy in Africa
Two letters appearing in the Feb. 20 issue of the Journal of the American Medical Association refute an October analysis that said patents are not a barrier to initiating HIV/AIDS drug therapy in sub-Saharan Africa. In the Oct. 17, 2001, issue of JAMA, Amir Attaran of the Center for International Development at Harvard University and Lee Gillespie-White of the World Intellectual Property Organization submitted a "special communication" in which the researchers asked the intellectual property divisions of eight major pharmaceutical companies to disclose "each patent or similar legal right" they held on 15 antiretroviral drugs in 53 African nations between October 2000 and March 2001. After reviewing the patent regulations, Attaran and Gillespie-White concluded that it is "doubtful" that patents on antiretroviral drugs are blocking access to the treatments in most African nations. They noted that while some major drugs such as lamivudine, zidovudine, nevirapine and nelfinavir were patented in the majority of nations, most of the 15 listed drugs were patented in a median of only three African nations. Instead, they said that the real barriers to antiretroviral treatment are the high price of the drugs, a "lack of political will," poor health infrastructure and care, high tariffs and "inefficient drug regulatory procedures that exclude competing products from the marketplace" (Kaiser Daily HIV/AIDS Report, 10/17/01).
Patents Affect Drug Combinations
In the first letter, a group of doctors from the departments of public health and clinical sciences at the Prince Leopold Institute of Tropical Medicine in Antwerp, Belgium, state that "'[d]ifferential pricing' of antiretroviral medications between industrialized and developing drug markets should be systematically and promptly adopted" because patents "do matter" and "have caused and are still causing significant delays in providing appropriate medications, especially in South Africa." The authors say that the patents on zidovudine and nevirapine block the use of the triple drug combinations zidovudine/lamivudine/nevirapine and stavudine/lamivudine/nevirapine in 33 of 53 and 25 of 53 African nations, respectively, in the Attaran/Gillespie-White survey. Those combinations are "often considered among the most appropriate for developing countries because of a relatively simple dosing schedule and acceptable toxicity profile," they add. Patents will continue to block access to affordable medications "until public health takes precedence over patent law protection in developing countries," the authors conclude (Boelaert et al., JAMA, 2/20).
Let Developing Countries Use TRIPS Provisions
In the second letter, a group of medical personnel from Doctors Without Borders agrees with the assertion that Attaran and Gillespie-White's analysis did not take the "drug combinations required for effective therapy" into context and asserts that developing nations have the right to import or produce generic drugs under the Trade Related Aspects of Intellectual Property Rights agreement. Zidovudine and lamivudine are "central to AIDS treatment," representing 60% of nucleoside reverse transcriptase inhibitor sales in major pharmaceutical markets, they state, noting that the combination is patented in 37 of the 53 countries in the survey. Doctors Without Borders uses the two drugs along with nevirapine as its first-line treatment regimen in its programs in Cameroon, Kenya, Malawi and South Africa. That combination is patented in 75% of the African nations surveyed, the authors write. They state that if patented medications remain too expensive, "developing countries must be supported to use safeguards in TRIPS to produce or import lower-priced generics." They note that developing countries' rights under TRIPS are "significantly undermined by claims by industry lobbyists and certain governments, using the ungrounded conclusions of the article by Attaran and Gillespie-White," and conclude that if developing nations cannot secure cheaper AIDS drugs, "the consequences for global public health could be disastrous" (Goemaere et al., JAMA, 2/20).