Print version ISSN 0042-9686
Bull World Health Organ vol.81 n.2 Genebra Jan. 2003
Deadlock on access to cheap drugs at global trade negotiations
At the end of 2002, the United States rejected a compromise proposal aimed at giving developing countries without local manufacturing capacities access to affordable life-saving drugs. At a December meeting at the World Trade Organization (WTO) in Geneva, negotiators of several of the 144 WTO members expressed their regret about the failure to reach an agreement by the intended deadline, which was the end of last year. Eduardo Perez Motta, Chairman of the WTO Trade-related Aspects of Intellectual Property Rights (TRIPS) Council and author of the compromise proposal, even apologized to sufferers from diseases in the developing world for the failure to come up with a viable solution. Meanwhile, in an attempt to reinvigorate the stalled negotiations, European Union (EU) Trade Commissioner Pascal Lamy put forward another compromise solution.
The bone of contention is the export of generic versions of drugs protected by patent to developing countries that lack manufacturing capacity to produce the generics themselves. At their fourth conference in Doha, Qatar, in November 2001, WTO ministers adopted a Declaration on TRIPS and public health. The agreement, usually referred to as the Doha Declaration, allowed poor countries to produce urgently needed drugs even if the drugs in question are under patent protection, a procedure known as compulsory licensing.
Even back then, however, WTO negotiators admitted there was a shortcoming in the Doha Declaration: the contentious paragraph 6 the Declaration bluntly states that "members with insufficient or no manufacturing capacity could face difficulties in making effective use of compulsory licensing ... We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002". This is because, according to TRIPS guidelines, drugs made under compulsory licence are intended predominantly for the domestic market, that is, not for export.
But the recent TRIPS Council meeting failed to deliver one, even though a compromise proposal, drafted and circulated by Perez Motta, was on the table. At the end of lengthy argument, the United States was the only country that refused to endorse the proposal. The US delegation considered the compromise which did not restrict the range of diseases covered to be too broad in scope, and insisted that instead the agreement should be limited to drugs for HIV/AIDS, malaria, tuberculosis and similarly infectious epidemics. According to a statement by the United States trade representative Robert Zoellick, issued on 20 December, such a focus on infectious diseases would reflect the original intentions of the Doha Declaration.
That is not the way Ellen T'Hoen of Médecins sans Frontières (MSF) sees it. "Already in Doha the United States tried to limit the scope of diseases," she pointed out. "None of those proposals of theirs made it through those negotiations. As a matter of fact, paragraph 4 of the Doha Declaration is very clear about this point: no limits [in terms of disease range]. In a way these attempts open up the whole Doha Declaration again." For T'Hoen the latest developments represent a "tragic U-turn in the healthtrade debate."
T'Hoen is not alone in her critique. Celine Charveriat of Oxfam says: "The fact that the European Union and the United States argued that developing countries should not have access to affordable generic drugs for asthma and diabetes, which kill and debilitate millions in these countries, proves that profits still come before people's lives and that the WTO has powers totally beyond its competence."
The United States interpretation of the Doha Declaration also raised eyebrows at WHO. "Our understanding of the Doha Declaration is that it is fairly inclusive," says Jonathan Quick, head of Essential Medicines at WHO. "The idea of either the WTO or the WHO having a single global list [of diseases] is difficult to reconcile with the changing and diverse epidemiology of the world." That is why, in a statement on 17 September 2002, WHO described desirable solutions to the "paragraph 6 problem" as having a "broad coverage in terms of health problems and the range of medicines."
But according to MSF, Oxfam and other nongovernmental organizations (NGOs), even the Perez Motta proposal would have been insufficient to meet the real needs of the developing world. In an open letter to WTO delegates, the NGOs urged developing countries to reject the draft. "Nobody was happy with it," T'Hoen says. "The procedures it proposed are so complicated that it would have led to a paper solution, not a practical one."
So for T'Hoen the December failure is not entirely bad news. "This offers an opportunity to go back to the drawing board and hammer out something that is better." An ideal solution, T'Hoen adds, should be drafted like the Amendment 196 to the European Medicines Directive, which the European Parliament adopted last October and which states: "Manufacturing shall be allowed if the medical product is intended for export to a third country that has issued a compulsory licence for that product." T'Hoen says "That's it a very nice and simple solution. No strings attached".
Another initiative to break the current deadlock was launched by EU Trade Commissioner Pascal Lamy in early January. Blaming a "lack of trust" between the United States and developing countries for the failure, Lamy suggested WHO should be actively involved in the process. "When there is too much mistrust in the game you have to call on a third party, and the WHO is a trusted party," Lamy said at a press conference in Brussels.
Lamy presented a list of infectious epidemics, covering more than 20 diseases "generally recognized as those which have the most damaging impact on developing countries". Lamy stressed, however, that this was not intended to be a restrictive list; with any other disease or health issue, affected countries should ask WHO to assess the severity of the situation and make recommendations as to how to respond to the problem. Lamy said he was convinced that his proposal "will be able to break the deadlock and rapidly achieve a final agreement".
WHO's Jonathan Quick considers the Lamy initiative "reasonable"
The next deadline is approaching fast. WTO Director-General Supachai Panitchpakdi recently said the aim would be to reach an agreement by the first meeting of WTO's governing General Council scheduled for 10 February in Geneva. Jonathan Quick is hopeful that a solution will be achieved before too long. "The `spirit of Doha' has been tested, that is for sure; people are looking at the part of the glass that isn't full yet. But in fact much of the key content [of the Doha Declaration] is there and has been very helpful," he says.