WTO Paragraph 6 Meeting Aims At Improved Use Of Health Waiver

The agenda has been circulated for the upcoming annual World Trade Organization review of an amendment to international IP trade law that has so far failed to increase access to needed medicines for the poorest economies. It shows a deeper look at existing measures and opens the possibility of new solutions to the issue.

The agenda for the 27 October meeting, obtained by Intellectual Property Watch, shows a programme for substantive consideration of how the so-called Paragraph 6 solution to the 2001 Doha Declaration on TRIPS and Public Health is working. The meeting is intended to result in next steps and recommendations. It also will consider alternatives to the use of Paragraph 6, and will include input from UN agencies such as the UN Conference on Trade and Development, the World Health Organization and the World Intellectual Property Organization.

TRIPS is the 1994 WTO Agreement on Trade and Intellectual Property Rights, which contains flexibilities for countries wishing to use compulsory licences to obtain more affordable versions of needed medicines.

Paragraph 6 of the Doha Declaration mandated governments to solve the problem of countries lacking pharmaceutical manufacturing capabilities not being able to take advantage of TRIPS flexibilities. In August 2003, WTO members agreed on a paragraph 6 solution, a temporary waiver to TRIPS rules that require predominately all medicines produced under compulsory licence be for the domestic market of the country producing them. But the waiver has only been used once, by Rwanda importing from Canada. The waiver was approved by WTO members as the first amendment to TRIPS in December 2005 but so far not enough of the required two-thirds of member countries have ratified it for the amendment to permanently enter into effect so the August 2003 temporary waiver remains in force. The WTO webpage on TRIPS and Public Health is here.

In September, WTO held a workshop to help members use TRIPS flexibilities for health.

In June of this year, WTO members agreed to a daylong meeting on paragraph 6 at the October meeting of the TRIPS Council, which annually conducts a review on the issue at that time (IPW, 10 June 2010, WTO/TRIPS).

The public health meeting will fill the second day of the 26-27 October TRIPS Council meeting (the first day likely will cover usual issues that arise such as a proposed TRIPS amendment to require disclosure of origin, and a proposal to extend higher level geographical indications protection to products beyond wines and spirits).

[Update: According to a source, some ambassadors to the WTO met on 15 October outside of the WTO (in the “cocktail” approach aimed at possibly getting negotiations on track) to discuss the disclosure of origin proposal, which is related to an analysis of TRIPS and the UN Convention on Biological Diversity.]

A third day, 28 October, will be the Special Session on the mandated register for geographical indications on wines and spirits.

In his note to members regarding the 27 October meeting, TRIPS Council Chair Martin Glass of Hong Kong said: “I have held consultations with a number of Members on how to structure the Council’s discussion during the second day of its meeting in order to make the review as useful as possible. In the light of these consultations, I have prepared the attached list of topics according to which I intend to structure the discussion at the review. I have made every effort to make sure that there are appropriate headings under which all of the topics delegations have mentioned could be adequately discussed.”

The 27 October Paragraph 6 meeting agenda (typed by Intellectual Property Watch) is as follows:

WTO OMC

Topics for discussion in the annual review of the Paragraph 6 System

1. Experience of Members who have used or considered using the System

* Experience in case of exports of medicines from Canada to Rwanda
* Experience by any other Members who may have considered the use of the System as potential importers or exporters and reasons why the System was not used
* Any obstacles or concerns about notifying to the WTO needed products
* Any other obstacles or concerns faced by Members
* Discussion

2. Implementation of the System into domestic legislative and regulatory framework

* Presentations by Members who have implemented the System as potential exporting and/or importing Members
* Feedback by those Members that have not yet implemented the System, in particular any problems encountered in its implementation
*Discussion

3. Process of acceptance

* Presentation by the WTO Secretariat on the procedural requirements and the current status of acceptances
*Any difficulties or concerns faced by Members in the process

4. Capacity building on the Paragraph 6 System and related TRIPS flexibilities

* Presentations by the Secretariats of the WTO, UNCTAD, WHO and WIPO
*Discussion

5. Any alternatives to the use of Paragraph 6 System to achieve the objective of access to medicines, procurement policies, and other related aspects affecting access to medicines raised by Members

* Presentations by Members and Observers, including the WHO Secretariat, and the WTO Secretariat
* Discussion

6. Next steps and recommendations

[END]