WTO General Council Extends Deadline For TRIPS Health Amendment

The first and only amendment to the 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was agreed with much aplomb at the Hong Kong ministerial in 2005. But getting countries to ratify the amendment has proven more difficult.

Yesterday, the WTO General Council again agreed to extend the deadline for countries to adopt the amendment at national level, according to the WTO. The deadline has been moved several times in the past and now is 31 December 2013.

Two-thirds of the WTO membership must ratify the change for it to go into effect. To date, about 39 appear to have done so (with the European Union counted as one), according to a website tally kept by the WTO. TRIPS Council Chair Ambassador Federico González of Paraguay told the General Council yesterday that with the present WTO membership of 153, the target for acceptance is 102, a WTO official said.

At issue is a change to the TRIPS agreement to address a perceived problem of countries lacking pharmaceutical manufacturing capacity not being able to take advantage of the TRIPS allowance to produce generic versions of patented drugs under compulsory licence primarily for domestic use. Under TRIPS, countries are permitted to produce under compulsory licence predominately for domestic use, but it was later recognised as problematic for countries that cannot produce their own and therefore must import. So a waiver was created that allowed production under compulsory licence for export to those countries lacking manufacturing capability.

TRIPS went into effect in 1995, and at the 2001 WTO ministerial in Doha, Qatar, members adopted a Declaration on TRIPS and Public Health, which contained seven paragraphs reinforcing flexibilities and the importance of IP rights. Paragraph 6 on the exportation question was left unresolved and directed members to urgently come up with a solution.

A temporary waiver to the TRIPS rules was reached on 30 August 2003, and the 6 December 2005 amendment made it permanent – once it is ratified by enough members. Countries could be said to have less incentive to adopt the permanent amendment since the temporary waiver remains in effect.

But there also has been much discussion about whether the “Paragraph 6 solution” has been effective, as after 8 years it has only been used once, by Canada and Rwanda. A variety of excuses were given as to why that was not repeated, such as that the process is to cumbersome, or that Rwanda did not do what was necessary for it to work.

The WTO Council on TRIPS recently approved the extension of the deadline already (IPW, WTO/TRIPS, 26 October 2011).

Last week, WTO Director General Pascal Lamy told a meeting celebrating 10 years of the TRIPS and Public Health Declaration that the very presence of the paragraph 6 waiver could be said to have been significant for developing countries negotiating prices and increased access.

A slow but steady progression of countries continues to ratify the amendment, with the two most recent being Cambodia (1 November) and Panama (24 November). Remaining countries were urged to follow through on the process, but it may take an additional push to get to the magic number in the next 14 months, just in time for the 10-year anniversary of the 2003 temporary waiver.

Separately, Lamy told the General Council on 30 November that he sees support for advancing negotiations in the most promising areas of the longstanding Doha Round of negotiations.