World Trade Organization still threatens supply of affordable AIDS drugs

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 Médecins Sans Frontières (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. That clock is ticking," she says.

Indeed, the Doha Declaration calls for a solution to be found by the end of the year. At the TRIPS meeting in June several proposals were presented, by the European Union, the USA and various groups of developing countries. "But the positions are pretty far apart," says T'Hoen. The industrialized countries generally suggest a more limited solution — say, a waiver system on a country-by-country or drug-by-drug basis. "The measures proposed by the EU and the US are accompanied by a whole set of conditions; they are so complicated that they are practically unworkable," she says.

Brazil, Thailand, India and a whole range of other developing countries, along with MSF and other nongovernmental organizations, usually ask for a broadly defined solution. Their suggestion is that the WTO should issue an "authoritative interpretation" of Article 30 of the TRIPS agreement. Such an interpretation would recognize the right of each country to authorize another country to make, sell and export patented drugs — without the consent of the patent holder — to meet public health needs wherever they arise. "This is definitely the simplest solution," says Fleet. "It can be implemented without as much procedural burden as some of the other proposals."

While negotiations are going on, MSF has already taken the next step: in pilot projects in nine developing countries, which include South Africa, Cameroon and Thailand, they have supplied a total of 1000 HIV patients with ARVs. The results — presented at the AIDS conference in Barcelona — are encouraging. "We have shown that ARV therapy is doable even in Africa.

It keeps people alive just as it does in North America and in Europe," says T'Hoen. Another case in point is the Brazilian AIDS programme: since 1996 when the Brazilian government decided to provide universal access to ARVs through the country's own generic industry, AIDS-related mortality has dropped by more than 50%. The success of ARV therapy has prompted WHO to try and scale up access to ARVs so that three million patients in developing countries are receiving them by 2005 — "quite a daunting challenge," as Julian Fleet of UNAIDS admits.

This makes it all the more imperative to come up with global trading rules everyone can agree on, says Ellen T'Hoen. "The viability of the Doha Declaration depends on solving the export issue. Without that, it's just an empty shell," she says. Julian Fleet of UNAIDS is optimistic that a solution can be found before too long. "If the commitment we have seen from the TRIPS Council so far is a signal, it looks quite promising," he says. According to WTO spokesperson Peter Ungphakorn a solution can be expected after the last TRIPS Council meeting of the year, in November.

Michael Hagmann, Zurich

World Health Organization Genebra - Genebra - Switzerland