At a meeting on Nov 25-27 in Geneva, Switzerland, the Council for the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) was expected to finalise a plan that would enable generic drug manufacturers in countries such as Brazil, India, and China to export drugs still under patent, under certain circumstances, to countries with little or no manufacturing industry.
Instead the TRIPs Council meeting, which followed a "mini-ministerial" meeting held earlier in November (see Lancet 2002; 360: 1670), ended without any prospect of reaching agreement.
During the meeting the USA, Japan, and Canada argued in favour of the introduction of a temporary waiver against bringing disputes to the WTO if the case concerns generics that are to be imported to the least developed countries. Other countries, particularly developing countries, supported by groups such as Oxfam and Médecins Sans Frontières, preferred a permanent amendment of TRIPs. This, they suggested, would offer certainty to all parties and an encouragement to manufacturers of generics to gear up for larger-scale production.
At present, a WTO agreement interpreting TRIPs, known as the "Doha Declaration", allows countries to issue compulsory licences during national emergencies such as HIV/AIDS, malaria, tuberculosis, and other epidemics. In these circumstances, a local third-party manufacturer may produce the necessary drugs for domestic use and reasonable compensation must be paid to the patent holder.
At the meeting, the USA attempted to limit the diseases that might be covered by the new agreement to HIV/AIDS, tuberculosis, and malaria, and "other infectious epidemics of comparable gravity and scale that may arise in the future". This restrictive language was not acceptable to other members, however. Disagreement also arose at the meeting as to what might constitute reasonable compensation and who might be liable to pay it.
The USA further endeavoured to limit the number of countries that might benefit from the importation of cheaper generic versions of patented drugs. The Council agreed that the 49 least developed countries should be automatically entitled to benefit, but no agreement was reached on the extension of this to other developing countries. Developing countries rejected this division.
The US position is undoubtedly in line with the desires of industry. A letter dated 25 Nov, 2002, from 20 pharmaceutical companies to the US Trade Representative, Robert Zoellick, states: "An open-ended or unclear exception to the standards for patent protection would seriously undermine our interest and set back the long-term public health objectives Doha was designed to achieve.
We urge you to negotiate a solution that is specifically limited to the diseases that were the focus of the Doha Declaration, namely HIV/AIDS, TB and malaria and other epidemics of similar scale. In addition, it should be clear that only truly disadvantaged countries in sub-Saharan Africa, be the recipient of the changed rules."
The TRIPs Council agreed that the 49 least developed countries should be automatically entitled to benefit, but no agreement was reached on the extension of this to other developing countries.