Patents on Antiretroviral Medicines Are Not Barriers to Access in African Countries, Researchers Write

It is "doubtful" that patents on antiretroviral drugs are blocking access to the treatments in most African nations, Amir Attaran of the Center for International Development at Harvard University and Lee Gillespie-White of the World Intellectual Property Organization write in a "special communication" to the Journal of the American Medical Association. 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. While some major drugs such as lamivudine, zidovudine, nevirapine and nelfinavir were patented in the majority of nations, most of the drugs were patented in a median of three African nations. The researchers note that it is unclear why the pharmaceutical companies did not pursue patents in all of the countries; some of the nations do not allow pharmaceutical patents, but they are legal in most countries. According to Attaran and Gillespie-White, the companies most likely abandoned some patent applications because of the time and cost involved and because most patents yield small financial returns in poor countries. Poor local enforcement may have also contributed to the companies' decisions not to pursue patents.

Money, Political Will Real Barriers
The researchers write that, as the majority of antiretroviral medications are not patented in African nations, patents are not responsible for poor drug access, a conclusion that "counters some of the sweeping policy arguments made for or against patents." 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," the researchers write. They suggest that countries should respect patent laws, but that the pharmaceutical companies that hold the patents should "reciprocally supply medicines to the global poor without profit, but also without loss." They cite several discount initiatives by Merck, Bristol-Myers Squibb, Abbott Laboratories and GlaxoSmithKline that should serve as models. In addition, Attaran and Gillespie-White say that the companies should consider licensing the rights to the drugs to "high-quality generic manufacturers willing to supply the drugs at low prices." International financial aid to fund the purchase of the drugs is also "essential," they conclude (Attaran/Gillespie-White, JAMA, 10/17).

Concurring Research
The report supports research by PhRMA, the U.S. pharmaceutical industry association, that found that patent coverage in South Africa for the 16 antiretroviral drugs used to treat HIV/AIDS was below 20%. Out of 52 nations analyzed in the PhRMA study, only South Africa had "more or less across the board" patent protection with patents on 15 of the 16 drugs. "For these drugs, Africa is a patent desert. Patents are simply not an obstacle to access in almost every sub-Saharan African nation," the PhRMA report concluded. The report also cited poverty and a lack of health infrastructure as reasons for poor drug access. Most of the nations studied spend less than $10 per person per year on health.

Reaction From AIDS Activists
In a statement issued today, five health organizations, including Oxfam and Medecins Sans Frontieres, refuted the findings, saying the same data used in both studies show that patents remain a barrier to the "most practical and sought-after drug combination" used to treat HIV/AIDS (Lamont/Williams, Financial Times, 10/17). Jamie Love of the Consumer Project on Technology cited GlaxoSmithKline's 3TC and Boehringer Ingelheim's nevirapine and two of the desired treatments that remain patented in most African nations. "Anything you could manufacture for under $500 is patented," he said (Boseley, Guardian, 10/17). "If you know what's going on on the ground in Africa, [Attaran and Gillespie-White's report] is really an offensive piece ... that is attacking the interests of the most powerless people on earth now," he added (Donnelly, Boston Globe, 10/17). Richard Elliot, director of policy and research for the Canadian HIV/AIDS Legal Network, said the "blanket statement' made by the report "cannot be substantiated," adding that "[n]o one has ever said that patents are the only barrier, and this research is condescendingly criticizing activists who have been pushing for changes on many levels." Attaran, in an interview with the Toronto Globe and Mail, defended his conclusions, saying it is "intellectually untenable to say that patents are the problem in Africa today. The whole continent is being deprived of treatment because of a lack of money -- not because of patents" (Picard, Globe and Mail, 10/17).