Rwanda Pioneers Use Of WTO Patent Flexibility For HIV/AIDS Medicine

By Tove Iren S. Gerhardsen
Years after it was permitted under international trade law, the first country has notified the World Trade Organization that it will use a flexibility allowing it to address public health needs by importing a patented medicine produced without authorisation of the patent holder.

Rwanda this week told the WTO it would import HIV/AIDS medicine produced in Canada. In its notification to WTO, the government said that “based on Rwanda’s present evaluation of its public health needs, we expect to import during the next two years 260,000 packs of TriAvir, a fixed-dose combination product of Zidovudine, Lamivudine and Nevirapine manufactured in Canada by Apotex, Inc. However, because it is not possible to predict with certainty the extent of the country’s public health needs, we reserve the right to modify the foregoing estimate as necessary or appropriate.”

The submission IP/N/9/RWA/1 is dated 19 July 2007 and can be searched at www.wto.org under “documents.”

This makes Rwanda the first and only country so far to appear on a dedicated WTO website for such notifications.

The move comes at a time when the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been criticised from various sides in the public health arena for having a potentially deleterious impact on poor countries experiencing public health crises.

Brazil and Thailand have recently made use of related TRIPS flexibilities for patented pharmaceutical products, against heavy industry pressure (IPW, Public Health, 7 May 2007) and 12 March 2007). But some would argue that Rwanda, a small economy, has taken a bold step as there appears to have been pressure on countries not to use this provision, sources said.

Rwanda will make use of what is referred to as the “paragraph 6” system, referring to paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, agreed to at the 2001 WTO ministerial in Doha, Qatar.

This paragraph says that countries should be allowed to export medicines produced under compulsory license – meaning patented products can be produced without the approval of the patent holder who nevertheless receives some remuneration – to countries unable to produce the medicines themselves. It states:

“We recognise that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.”

A waiver allowing for this was agreed to in 2003, and this was made a permanent amendment to the TRIPS agreement on 6 December 2005, just before the 2005 WTO ministerial meeting in Hong Kong (IPW, WTO/TRIPS, 6 December 2005). Some sources argued at that time that this agreement would be used as part of the overall Doha talks, but little progress was made in Hong Kong, or later.

Before the issue was raised in the Doha Declaration, which in general helped explain the TRIPS agreement, countries were only allowed to export 49 percent of such production under TRIPS paragraph 31.

The WTO said that the notification is required by paragraph 2(a) of the 30 August 2003 General Council decision, “which requires eligible importing countries to report the details of the medicines they intend to import.”

As a least-developed country which only needs to fully implement TRIPS by 2013 (2016 for pharmaceutical patents), Rwanda does not have to notify that it plans to be an “eligible importing member,” under paragraph 1(b) of the 2003 decision, WTO said. But there are WTO notification requirements for the exporting country, WTO said.

In its notification, Rwanda also stated: “Pursuant to Paragraph 7 of the Doha Declaration and implementation thereof by the TRIPS Council (Decision of the Council for TRIPS of 27 June 2002), we have decided that we will not enforce rights provided under Part II Section 5 of the TRIPS Agreement that may have been granted within Rwanda’s territory with respect to the Product.” That section of TRIPS refers to patentable subject matter.

Rwanda was not available for comment.

Deadline for Members’ Acceptance of Amendment

WTO member states have to implement the 2005 decision into their national law in order to use it, and separately, they have to accept it in order for it to come into force. So far, seven member states have accepted but two-thirds need to do so by the end of 2007. This deadline may be extended if needed, WTO said.

There is currently discussion in the European Union about whether to accept the 2005 decision as many argue that it does not work in its current form (IPW, Public Health, 12 July 2007).

Tove Gerhardsen may reached at tgerhardsen@ip-watch.ch.