At a World Trade Organization (WTO) meeting in Geneva on Dec 20, 2002, the USA refused to support a draft plan to let developing countries override patent laws and import cheap generic drugs. The other WTO member countries accepted the proposals, after protracted negotiations, but the US delegation rejected them, saying that the proposed wording for the global deal failed to protect patents on drugs for non-infectious diseases such as asthma, diabetes, and obesity, which the delegation said would undermine research and development.
The USA's lack of support and disagreement on which diseases should be covered by the plan led to failure to meet the Dec 31, 2002, deadline, set in Doha, for agreement in negotiations on special and differential treatment for developing countries and on access to essential medicines for poor countries lacking manufacturing capacity.
Modification of Article 31(f) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is being sought to address the problem that production under compulsory licensing (production of medicines by companies other than the patent holder) must be predominantly for the domestic market, which hinders countries unable to make drugs from importing cheap generics.
The USA insists that developing countries should only be allowed to import cheap generics for infectious epidemics specified as HIV/AIDS, malaria, tuberculosis, or similar infectious diseases of comparable gravity and scale, including those that may arise in the future.
However, the Doha Declaration of November, 2001, adopted by all 144 WTO member countries including the USA, is "supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all".
Although the only diseases singled out in the Declaration are HIV/AIDS, malaria, and tuberculosis, it is stated that "other epidemics" "can represent a national emergency or other circumstances of extreme urgency". Moreover, the Declaration recognises that each member has the right to determine what constitutes a national emergency and has the freedom to determine on what grounds compulsory licences can be granted.
In the past, the USA has proven flexible on what it deems to be a public-health emergency. In 2000, the US government filed a complaint with the WTO when Brazil produced cheap generic versions of antiretrovirals, undermining US pharmaceutical companies' patent rights but dramatically reducing AIDS-related deaths in Brazil. Yet in 2001, faced with a mere handful of cases of anthrax, the US government threatened to override Bayer's patent on ciprofloxacin by endorsing compulsory licensing (see Lancet 2001; 358: 1563).
Certainly what is, or is not, a public-health emergency varies with country and with time. Global and regional burden-of-disease figures (see Lancet 2002; 360: 1347-60) show that high blood pressure, obesity, tobacco, alcohol, high cholesterol, and indoor smoke from solid fuels are major causes of disease burden in developing countries as well as the expected infectious diseases and malnutrition. Patent protection does not apply to all these causes, but trade pressures, taxation laws, or political will for change might, which is why it is surely wise to consider asking for help to define which diseases constitute emergencies.
And this is exactly what Pascal Lamy, European Union Trade Commissioner, proposes. In a letter to all WTO Trade Ministers dated Jan 7, Lamy suggests that members wishing to import medicines to meet any public-health concern should seek WHO advice. As he says, "Involving the WHO with its public health expertise would provide a mechanism to ensure the Doha Declaration can be used in good faith".
Both the issue of special and differential treatment for developing countries, and agreement on which diseases should be covered by the draft plan on intellectual property and health, could - and we urge should - be discussed again at a WTO General Council meeting scheduled for Feb 10-11 in Geneva.
Lamy's proposal should be given serious consideration as should out-licensing as an alternative to compulsory licensing in some cases. It would be refreshing if public-health needs were put ahead of all others at the February WTO meeting, as they were in 2001 in Doha, and a global deal on access to medicines agreed.
The USA insists that developing countries should only be allowed to import cheap generics for infectious epidemics specified as HIV/AIDS, malaria, tuberculosis, or similar infectious diseases of comparable gravity and scale, including those that may arise in the future. However, the Doha Declaration of November, 2001, adopted by all 144 WTO member countries including the USA, is "supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all".