Patent Politics: Nongovernmental Organization Access Effort Dealt Stealth Blow By Ivy League Development Institute

"We observe no apparent correlation between access to antiretroviral treatment, which is uniformly poor across Africa, and patent status, which varies extensively by country and drug."

-- Amir Attaran, Center for International Development, Harvard University, and Lee Gillespie-White, International Intellectual Property Institute
Source: JAMA 286 (15): 1886-92

A controversial paper published in the 17 October issue of the Journal of the American Medical Association (JAMA) argues that "patents in Africa have generally not been a factor in antiretroviral drug treatment access." And similar research by the Pharmaceutical Manufacturers Association (PhRMA) which catalogued the patent situation in 53 African nations, showed that for the 15 antiretroviral drugs used to treat HIV infection, patent coverage was about 21%. Only in South Africa was patent protection extensive, with 13 of the 15 drugs patent protected. "For these drugs," PhRMA writes in a related press release, "Africa is a patent desert."

While one would perhaps expect this kind of polemical research from the likes of an intellectual property organization (the Institute openly acknowledges its receipt of a $25,000 grant from Merck upon completion of the manuscript), the study's lead author Amir Attaran comes from among the ranks of the Kennedy School's Center for International Development at Harvard.

Professor Attaran's motivation seems to be an attempt to shore up his boss' high-profile call some months ago for a dramatic increase in international donor assistance to AIDS, TB and malaria-stricken countries. The Center's director, Jeffrey Sachs, told The New York Times' Don McNeil that he supports Attaran's study (11/5). But the nongovernmental organizations (NGOs) that are treating people with AIDS and working to improve access to medicines say patents do block affordable, easier-to-take medicines from reaching people who need them.

Oxfam, Treatment Action Campaign, Consumer Project on Technology (CPT), Médecins Sans Frontières (MSF) and Health GAP agree with the claim that many barriers impede access to health care in Africa, and support their call for international financial aid to fund antiretroviral treatment. They believe, however, that the data presented in the paper do not support the conclusions drawn -- and "unwittingly shed light on the extent of patent barriers to treatment." In African countries, the most practical and sought after combinations, they argue, include fixed-dose medicines (two drugs in one pill) and affordable non-nucleosides. The most popular combination of AZT/3TC is patented in 37 out of 53 countries. And the only affordable non-nucleoside (nevirapine in generic form) is patented in 25 of 53 countries.

In a joint statement issued in response to the JAMA paper, the five NGOs observe that many of the non-patented drugs listed in the Attaran study, including some of the protease inhibitors, are not practical as first-line treatments in resource-poor settings because of side effects (which need to be monitored) and cumbersome dietary requirements.

And, as the Attaran/Gillespie team is quick to concede, their study data show that patents are concentrated in countries where pharmaceutical markets are the largest. In South Africa, which has 4.7 million people living with HIV/AIDS and represents half of the pharmaceutical market in Africa, 13 out of 15 antiretroviral treatments are patent protected. All tolled, fully half of the people with HIV/AIDS in Africa live in countries with significant patent barriers on antiretroviral drugs.

The authors conclude that even if prices of patented antiretrovirals come down, African countries will not be able to afford them. But since generic triple therapies can now cost as little as $30 a month, significant numbers of individuals -- and their employers -- can afford the treatment. Patented prices, by contrast, are still three times higher than generic prices. This means that for a given amount of the beefed-up international aid they understandably call for, three times as many people can be treated if generic production is permitted.

A draft declaration calling for a pro-public health interpretation of TRIPS (trade-related agreement on intellectual property) was put forward by 60 developing countries in the September 2001 TRIPS council session on access to medicines. The declaration, signed by 41 African nations, states that "nothing in the TRIPS agreements shall prevent members from taking measures to protect public health." The declaration, which is being considered at this month's World Trade Organization ministerial conference in Doha (Qatar), has been opposed by the United States, Switzerland, Japan and Canada.

If nothing changes, beginning in 2006, all WTO member countries will be obligated to grant 20-year minimum patents for medicines.

More recently, European governments have pledged to support clarification of the rules under which developing countries can break patents during times of national health emergencies. European Union foreign ministers have backed the use of TRIPS to allow governments to grant special licenses in order to manufacture drugs to fight epidemics like AIDS and tuberculosis. United States trade representative Robert Zoellick has taken the same position and says he has shown U.S. "good will" by offering to extend the deadline for full compliance with TRIPS for developing countries to 2016 -- with a 5-year moratorium on WTO challenges to any sub-Saharan nation that breaks patents to deal with health crises.

Brazil, India and South Africa, however, want stronger language and are spearheading the drive by developing countries to back a proposal that says: "Nothing in the TRIPS agreement shall prevent members from taking measures to protect public health."

As TAGline goes to press, little progress has been reported from the WTO meeting in Qatar -- even though the issue of drug patents in the face of public health crises is said to have dominated discussions there. Meanwhile, NGOs caution that, "It is critical that the false conclusions drawn from [the Attaran/Gillespie report] do not lead people to believe that patents are not an issue in access to life-saving medicines."