The 144 member countries of the World Trade Organization have approved another extension, until 2016, of the period during which least-developed countries can manufacture pharmaceuticals without paying royalties on their patents. A highly contentious issue remains on the agenda for Trade-related Aspects of Intellectual Property Rights agreement (TRIPS), however: how to allow poor countries without manufacturing capacities of their own to import urgently needed patented drugs from countries with generic drug industries.
Access to drug therapy is hugely uneven. The UNAIDS Report on the Global HIV/AIDS Epidemic, released shortly before the 14th International AIDS Conference in Barcelona (7-12 July), shows for example that of the 6 million people in developing countries who need antiretroviral (ARV) drug therapy, only 230 000--less than 4%--are getting it. In Africa, the continent hit hardest by the AIDS epidemic, only 30 000 of those infected with HIV are on ARV therapy.
These numbers are in stark contrast to those for high-income countries, where one in every three HIV patients is treated with costly ARVs. "Access to essential drugs should not be a luxury reserved for the wealthy," comments Ellen T'Hoen of Medecins Sans Frontieres (MSF) who have repeatedly called on the WTO and industrialized countries to redress the balance.
The major obstacle to increased drug access--though not the only one--is patent royalties, which make the drugs concerned unaffordable in most poor countries. At full price, triple therapy with branded ARVs can cost up to US$ 15 000 per year per patient. Generic drugs produced in Brazil, India and other developing countries have helped to slash these costs to around US$ 200 a year. In view of this startling contrast, the WTO, at its fourth Ministerial Conference in Doha, Qatar, last November, made a "Declaration on TRIPS and Public Health". It explicitly stated, for the first time, the primacy of public health over free trade: "The TRIPS agreement does not and should not prevent members from taking measures to protect public health." This means, in short, that by using "compulsory licenses" any country can produce patented drugs, whether the patent holder agrees to it or not. There is, however, an important restriction: drugs produced under compulsory licenses have to be "predominantly for the supply of the domestic market," as stated in the TRIPS agreement.
"Countries lacking local production capacity may not be able to find a generic supplier," says Julian Fleet, senior advisor for care and public policy at UNAIDS. Ellen T'Hoen agrees. "Production [of generics] for export is a huge problem. Once the TRIPS agreement is fully implemented in 2005, countries like India and Thailand, which currently export generic ARVs may no longer be able to do so--unless they are allowed to produce for export. …