Avian Flu Issues Could Arise At TRIPS Council Meeting

Issues surrounding nations’ legal ability to obtain sufficient quantities of patented medicines to protect their people from the spread of avian influenza may be addressed at today’s meeting of the World Trade Organization committee responsible for intellectual property rights matters.

The meeting of the WTO Committee on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has a full agenda of topics including public health, but not specifically including avian flu.

“This is a routine meeting of the TRIPS Council with a lengthy agenda,” a WTO official said Tuesday, adding, “Avian flu could be raised” by any delegation.

One of the key issues on the meeting agenda is how to address proposals for a permanent amendment to the TRIPS agreement to enshrine WTO members’ ability to import and export patent-protected pharmaceuticals made under compulsory license.

Under the 1994 TRIPS agreement, nations have the flexibility to issue compulsory licenses to get around patents if they deem it necessary. This was reconfirmed in the Declaration on TRIPS and Public Health agreed at the 2001 WTO ministerial in Doha, Qatar, at which the current round of market-opening talks was launched.

But the Doha Declaration also mandated an amendment to TRIPS to allow countries who deem a compulsory license necessary but who lack their own production facilities to import pharmaceuticals made by other countries under compulsory license. A temporary waiver for this purpose was agreed on 30 August 2003, and the committee has been working ever since to make it permanent.

As part of the 2003 waiver, a group of 23 developed nations plus 10 new members of the European Union, agreed not to use the waiver for import with an eye toward keeping out cheaper generic versions of the patented drugs.

A debate has resurfaced over an African proposal for making the waiver permanent as some members view it as making substantive changes that were not agreed in 2003. The African proposal does not address the legal standing of a chairman’s statement read out at the time of the decision with the intent of appeasing concerns about the abuse of the waiver that accompanied the 2003 decision.

By comparison, a competing proposal from the European Union is seen as giving legal status to the chairman’s statement by linking it to the decision. The EU proposal remains in play, although an EU official said it was never fully tabled and is not imminent. Rather, the official said, it was offered as a “good faith attempt to find a solution.”

Rather than amend the TRIPS text itself, the EU proposal would place the waiver into an annex, a notion some have resisted. Most developing countries appear to support the African proposal. Sources said Africa is under pressure from developed countries to withdraw its proposal.

Other agenda items for the 25 and 26 October TRIPS Council meeting include a review of TRIPS Article 27.3(b) on the patentability of inventions involving plant and animals. The committee is to examine the relationship between TRIPS and the international Convention on Biological Diversity, as well as the protection of traditional knowledge and folklore, and other issues.

Also on the list is an EU proposal on enforcement of intellectual property rights. In addition, issues related to geographical indications, or rights over items bearing place names, will be discussed. A special session on a GI register sought by Europe will be held on 27 and 28 October.

WTO FAQs On Public Health

In order to address the rise in interest in compulsory licensing and the avian flu, the WTO published a list of Frequently Asked Questions.

Some non-governmental groups have raised fears that the opt-out of the 2003 waiver means that these developed countries cannot import drugs necessary to address an emergency such as a pandemic of avian flu.

Consumers International, a group of consumer organisations, issued a statement this week urging WTO members “to consider the simple question: ‘Is the current system working?” The group requested the TRIPS Council to “immediately issue a clarification on how members who have opted out of the 30 August 2003 decision may opt back in.”

Consumers International also called for a TRIPS Council review on intellectual property rules related to health, including: an assessment of the medical threats to public health of issues such as the avian flu; the degree to which WTO members have prepared for such cases; the consistency of IP policies with the 2001 Doha Declaration; and whether the TRIPS agreement and its implementation should be modified to ensure the public can be protected in emergencies.

Ellen ‘t Hoen of Medécins Sans Frontières questioned why the same level of commitment and political will has not been there for health issues affecting poorer populations, such as HIV/AIDS.