GSK's combined lamivudine and zidovudine anti-AIDS drug Credit: Bob Bridges, GlaxoSmithKline

As Nature Medicine went to press, delegates to the World Trade Organization (WTO) were meeting in Doha, Qatar to discuss a range of trade issues, including the ability of nations to compel the licensing of patents on lifesaving drugs when faced with a public health crisis. Activists have argued that the issue highlights the stark hypocrisy of developed countries, but closer analysis reveals a more complex situation.

Around 25 million people in sub-Saharan Africa are infected with HIV but only 25,000 of them receive any drug therapy for the disease. According to non-governmental organizations such as Médecins sans Frontières (MSF), patents on the most effective antiretroviral drugs have kept the price of treatment out of reach for most Africans. MSF has campaigned vigorously to alter international trade rules to allow countries to bypass these patents. “The cheapest generic offer today for triple combination therapy is around $250–300 per year per patient, and the cheapest triple combination therapy by a brand-name manufacturer is probably between $800 and $1000,” says Anne-Valerie Kaninda, medical advisor for MSF.

The United States has opposed changes in the trade rules, but after the death of four Americans from anthrax, the US government subtly threatened compulsory licensing of the Cipro (ciprofloxacin) patent in order to extract a lower price from the antibiotic's manufacturer, Bayer.

Activists claim that the US government is maintaining a double standard, but others contend that groups like MSF have misunderstood the problem. The US threat against Bayer was permitted under current international trade rules, and was no different in principle from earlier negotiations Brazil conducted with drug manufacturers to get AIDS drugs at lower prices. “That is the TRIPS agreement and international law working exactly as it should,” says Amir Attaran, director of international health research at Harvard University, referring to the WTO's Trade-Related Intellectual Property Rights agreement.

Attaran is co-author of a new study that surveyed patent coverage for AIDS drugs in Africa (JAMA 286, 1886; 2001). His findings cast further doubt on the idea that patents are the key barrier to stopping the African AIDS epidemic, as Africa has only 22% of the possible patent coverage for AIDS drugs. Moreover, according to Attaran, “even in the cases where there are patents on drugs ... in every single one of those cases there is a discount or donation offer in force [from the manufacturer].”

In the paper, Attaran writes, “...geographic patent coverage does not appear to correlate with antiretroviral treatment access in Africa, suggesting that patents and patent law are not a major barrier to treatment access in and of themselves.”

Broken down by country, the data strongly suggest that poverty, rather than patent protection, is the primary barrier to AIDS treatment. “$350 a year is better than $1,000 a year ... but $350 a year is no more affordable to public health systems in Africa than $1,000 a year,” says Attaran. Indeed, the average per capita gross domestic product in sub-Saharan Africa currently stands at about $350 per year, and per capita health expenditures hover around $10.

Meanwhile, the US government has offered a compromise on patents: the Bush administration says that for the next five years, it will not pursue legal action against South Africa if that country violates AIDS drug patents held by US companies. But it is unclear what effect this measure will ultimately have, as South African president Thabo Mbeki has consistently refused to endorse anti-HIV drugs (Nature Med. 7, 1170; 2001).