World Trade Organization still threatens supply of affordable AIDS drugs.

News Health plans for Africa remain vague as G8 agrees to meet 10% of the need Last June the G8 leaders promised an additional US$ 6 billion in aid to Africa by 2006. Since then, organizations involved with crucial health pro- grammes on the continent have been busy determining what their share should be, but it is a relatively small pie to divide up. The G8 leaders described their Africa Action Plan as an ‘‘initial response’’ to the New Partnership for Africa’s Development (NEPAD), a revitalization strategy first championed by South Africa’s President Mbeki alongside the Presidents of Nigeria, Senegal, Egypt and Nigeria. NEPAD aims to put Africa onto ‘‘a path of sustainable growth and development.’’ The leaders of the 15 African countries endorsing NEPAD estimate that US$ 64 billion of investment is needed annually — 10 times the G8 pledge—for projects to improve health, trade, infrastructure and education. At the same time, NEPAD recognizes Africa’s own responsibility to create the conditions for development by ending conflicts, improving economic and political stability and strengthening regional integration. Health is a key component of both plans. NEPAD acknowledges that unless HIV/AIDS, malaria and tuber- culosis are brought under control ‘‘real gains in human development will remain an impossible hope.’’ The G8 countries for their part cite the persis- tence of malaria and tuberculosis as a ‘‘severe obstacle’’, while emphasizing that ‘‘HIV/AIDS affects all aspects of Africa’s future development and should therefore be a factor in all aspects of our support.’’ The G8 statement also gives special attention to polio, sup- porting the plan for its eradication in Africa by 2005. This is consistent with the WHO programme for eliminating the disease worldwide within the same time frame. However, critics argue that both NEPAD and the G8 plan lack detail on how they will tackle the continent’s massive health issues. For example, the HIV/AIDS epidemic ravaging Africa ‘‘is the major hindrance to devel- opment in Africa right now,’’ says Chinua Akukwe, an adjunct professor of public health at George Washington University. ‘‘Yet, I didn’t see a lot of specificity in theG8 action plan in regard to HIV/AIDS. And I blame that on a lack of specificity, or priority attention, in the NEPAD document. I had expected NEPAD, especially since it is home-grown, to be very clear on how the epidemic will be handled in Africa.’’ NEPAD leaders are still debating the approach Africa will take in dealing with the crisis. One of the questions under debate is whether Africa should have its own agency to deal with the epidemic or rely on international orga- nizations. Akukwe, a Nigerian by birth, expects that in a year or two NEPAD will take a stronger and more specific stance on Africa’s role in fighting the disease. ‘‘And then we can re-engage the G8 leaders in terms of money and technical assistance,’’ he said. Funding for health programmes in nations that fail to meet the NEPAD criteria is another tricky question. The ground rule for this new-fashioned partnership is that all aid will be tied to democracy, legal transparency, human rights and sound economic practice. African leaders embracingNEPADvow to hold themselves and each other accountable for their actions. But health issues that cross borders raise difficul- ties. Sudan, for example, has not associated itself with NEPAD though it still battles polio. In such cases, multilateral agencies could distribute the G8 funds as unspecified grants to be used ‘‘where most needed on the African continent,’’ says Muller. ‘‘The mechanisms that the G8 use to channel funds will be very telling.’’ Meanwhile the leaders of the eight largest national economies pledged support for health and other initiatives, but only Canada, the G8 summit host, declared its commitments in concrete terms at themeeting. Canadians will give a total of US$ 4 billion in the next five years to Africa’s development, but that includes just US$ 350 million in new funds. Of the new funds, about US$ 35 million is earmarked for the development of an HIV vaccine for Africa and other Africa-based HIV/ AIDS health research. Another US$ 35 million will go towards polio eradication over the next three years. Some US$ 70 million will fund agricul- ture and water projects. Germany said its pledges are likely to be detailed only after the elections in September. n Charlene Crabb, Paris Global AIDS conference finds the issue is cash Money — or rather the lack of it — was at the heart of discussions at the 14th International AIDS conference in Barcelona from 7 to 12 July. Speaker after speaker denounced the polariza- tion between HIV prevention and HIV treatment campaigns, and emphasized that prevention and treatment were complementary strategies. There was widespread consensus that antiretroviral drugs should be introduced into poor countries, but much debate about why this was not happening and where the money should come from to ensure that it did. ‘‘Antiretroviral treatment has slashed mortality in high income countries,’’ said UNAIDS Executive Director Peter Piot at the opening ceremony. ‘‘Brazil has shown it can be done elsewhere. So why are only 30 000 Africans getting antiretroviral President Mbeki of South Africa, a pioneer of NEPAD. G C IS Ph ot o St ud io 761Bulletin of the World Health Organization 2002, 80 (9) treatment, when a hundred times that number need it?’’ Bernhard Schwartlander, WHO’s Director of HIV/AIDS, echoed Piot later in the week: ‘‘As we all know, since 1995, highly active antiretroviral therapy (HAART) has resulted in dramatic reductions in morbidity and mortality and greatly improved the quality of life. ‘‘There is no longer any reason to believe that this should not be possible in the poorer nations as well. Even if we do not close this unconscionable gap between the treated and the untreated, between the rich and the poor, we can prolong life for millions more.’’ But where was the money to come from to close this gap, and what was the best way to get the cheapest antiretroviral drugs? The Global Fund to fight AIDS, TB and Malaria — a new tool in the AIDS war since the last international AIDS conference (in 2000 in Durban, South Africa) — was the focus of much attention as the most obvious source of money. Richard Feachem, the Fund’s new Executive Director, vowed to make it a ‘‘modern, effective tool for delivering maximum impact with funds provided by donors’’. The fund’s initial grants would already increase sixfold the number of Africans able to get antiretrovirals, said Feachem, and already US$ 616 million was committed to be disbursed world- wide over the next two years. But he acknowledged that, ‘‘to succeed, the amount of money spent must be dramatically increased’’. ‘‘Many billions more will be required quickly to implement the high- quality proposals that we anticipate receiving during the next 12 months,’’ said Feachem. ‘‘Without rapid and substantial increases in financial support for the Global Fund, it will not be possible to support the most worthy of these plans.’’ US Health Secretary Tommy Thompson was shouted down by Act Up and other activists when he tried to explain to the conference why his country had not contributedmore to the Fund. Rwanda contributed ten times more in terms of a percentage of its GNP than the US, activists pointed out. Thompson countered that his government had already dedicated more money to AIDS than the previous administration, and was spending US$ 1 billion on fighting the disease this year alone. But at the close of the conference, former US President Bill Clinton said that, in order to pay its fair share of the US$ 10 billion needed annually to fight AIDS, the US contribution of US$ 800 million to the Fund would need to be increased by almost US$ 2 billion. This amounted to ‘‘less than two months of the Afghan war and less than 3% of the requested increases for defence in the current [US] budget’’, said Clinton. ‘‘We cannot lose the war on AIDS and win our battles to reduce poverty, promote stability, advance democracy and increase peace and prosperity,’’ said Clinton. ‘‘That is why I said it was a security threat when I was President. That is why every citizen on our small planet has a personal interest in ending AIDS.’’ Also at the closing ceremony, former South African President Nelson Mandela called on ‘‘all institutions, public and private, to make rapid and real progress’’ to ensure that all those who needed antiretroviral treatment had access to it. Mandela said that in a world where the treatment was available and antire- trovirals could return people with AIDS to good health, it was unacceptable that parents should die and leave their children orphaned. The issue of generic antiretroviral drugs was repeatedly raised by speakers and delegates as a way of lowering treatment costs. Children’s rights advocate — and Mandela’s wife — Graca Machel put the position clearly when she called on pharmaceutical companies to release their patents ‘‘so generic antire- troviral drugs can be available to the millions of poor people who need them’’. ‘‘We know they are there to make money and I don’t question that, but if you sell your medicines to 30 million people rather than three million, you will still make money.’’ n Kerry Cullinan, Barcelona World Trade Organization still threatens supply of affordable AIDS drugs The 144member countries of theWorld Trade Organization have approved another extension, until 2016, of the period during which least-developed countries can manufacture pharmaceu- ticals 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 manufac- turing 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 Me´decins Sans Fron- tie`res (MSF) who have repeatedly called on the WTO and industrialized coun- tries 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 Minis- terial 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.’’ 762 Bulletin of the World Health Organization 2002, 80 (9) News 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 coun- tries 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 nongovern- mental organizations, usually ask for a broadly defined solution. Their sugges- tion 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 coun- tries, 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 impera- tive 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. n Michael Hagmann, Zurich Headquarters of the World Trade Organization. Ju lia no Vi da le 763Bulletin of the World Health Organization 2002, 80 (9) News