External Opposition Rises To TRIPS And Public Health Deal

As negotiators at the World Trade Organization gather Tuesday to try to agree on a waiver to intellectual property trade rules for public health purposes, an increasing number of non-negotiators are telling them to wait out of concern for the negative impact of the waiver.

At issue is a mandated amendment to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to allow countries to export cheaper pharmaceuticals produced under compulsory licence to other members lacking production capabilities.

Three Democratic members of the US House of Representatives on 5 December issued a letter demanding clarification of the US government’s stance on the issue. Reps. Henry Waxman of California, Sherrod Brown of Ohio and Tom Allen of Maine criticised the United States’ commitment not to import generic versions of patented drugs even for public health reasons.

In addition, the United States “has reportedly pushed for provisions that could make it harder for all countries, including the poorest, the access generics in this manner,” they said. The congressmen noted that in 2002, the US Congress passed legislation that directs adherence to the 2001 Doha Declaration in US trade negotiations. The Doha Declaration states that TRIPS agreement “can and should be interpreted and implemented in a manner supportive of WTO member’s rights to protect public health, and in particular, to promote access to medicines for all.”

Separately, dozens of non-governmental groups from around the world have signed on to a statement calling on WTO members to refrain from codifying a temporary waiver agreed to on 30 August 2003.

“On 30 August 2003, the members of the WTO finally agreed on a mechanism with many procedures for allowing trade in compulsory-licensed medicines,” the NGOs said. “The procedures have been criticized by generic industry experts and activists alike for being too burdensome and unworkable in practice.”

“However,” they added, “the US and the EU are pressuring developing countries to accept that flawed August 30 agreement be locked in as a permanent amendment to the TRIPS Agreement – despite the fact that the mechanism has not been used since its introduction more than 2 years ago and its workability is uncertain.”

None of the countries appears to be balking at the notion of carrying the 2003 waiver forward intact, according to a Geneva source. African countries have signalled they are ready to agree to a conversion of the 2003 waiver (IPW, WTO/TRIPS, 6 December). Some larger developing countries continue to examine the legal ramifications of the draft amendment and members are expected to meet later on Tuesday to finalise the text. It would then be passed on to the WTO General Council in time for 13-18 December WTO ministerial in Hong Kong.

Debate over the draft waiver has turned to legal issues, according to sources, as members analyse whether the original intent of the 2003 waiver is kept intact in the new version. Because making a permanent “amendment” to an agreement (this would be the first amendment of TRIPS), requires different procedures than a “decision” like that in 2003, the text is laid out differently. This is addressed in a nine-point draft “choreography” under discussion.

A key point in the debate has been how to carry forward a statement read out by the General Council chairman in 2003. At the time, it was accompanied by statements and discussion by other members. African countries and advanced developing countries do not want new discussion to be held, but some members assert that the 2003 commentary should be carried forward with the chairman’s statement, a Geneva source.