Bridges Weekly Trade News DigestVolume 14Number 9 • 10th March 2010

TRIPS Council Debates Access to Medicines, Biodiversity


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Delegates discussed long-standing concerns about public health and biodiversity at a 2 March meeting of the Council of the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). At the close of the one-day session, they expressed support for continued review of a six-year-old initiative intended to help poor countries access affordable medicines.

TRIPS and public health

The Council’s public health discussions centred on the ‘30 August decision’, a 2003 deal among WTO members that allows developing countries that lack the capacity to manufacture drugs themselves to acquire lower-cost imports of essential medicines from rich countries. Specifically, the decision - which is also known as the ‘Paragraph 6′ agreement, referring to that section of the 2001 WTO Doha Declaration on TRIPS and Public Health - established terms for waiving the requirement that generic drugs that are produced without patent-holders’ consent must be ‘predominantly’ for the producing country’s domestic market.

The decision was seen as a major breakthrough when it was announced in 2003, even as some public health advocates warned that its technical requirements would render it too burdensome to be effective. Such criticisms are still on target, some say. Six and a half years after the decision was finalised, the provision has only been used once, when Canadian drug maker Apotex shipped two loads of compulsory-licensed HIV/AIDS drugs to Rwanda in 2008 and 2009.

Delegates attending Tuesday’s TRIPS Council meeting continued the debate over the August 2003 decision. Discussions on this followed up on an informal consultation led by Singaporean Ambassador Karen Tan, the outgoing chair of the TRIPS Council, on 12 February.

During that meeting, Tan reported to the Council on Tuesday, several developing countries expressed their fears that the system might not be up to the task of helping them get access to the medicines they need, given that it has only been used once. But several developed countries argued that how many times the system has been used is not a good indicator of the usefulness of the system. Such countries also pointed out, Tan reported, that there are other ways that poor nations can gain affordable access to patented drugs.

Representatives from Canada who attended Tan’s informal consultation shared their experiences with the group, providing a detailed timeline of the various events that took place between the finalisation of the 30 August decision and the delivery of the first batch of drugs just over five years later. Most of that time was taken up with bureaucratic hang-ups, the Canadians explained, including identifying a country to receive the drugs and complying with Rwanda’s procurement regulations, which require a competitive tendering process. But such steps are not written into the system outlined in the decision, the Canadian delegation said, and could be avoided in future initiatives.

Looking ahead, Tan continued, delegations at the 12 February meeting expressed support for the idea of annual reviews of the system’s functioning. They also said they would like to continue consultations with the incoming chair of the TRIPS Council, Martin Glass of Hong Kong, to consider how their various concerns might best be addressed.

Also on the public health front, India and Brazil repeated their calls at Tuesday’s meeting for the EU to reform its customs procedures so as to ensure that legitimate generic medicines in transit to the developing world are not unrightfully detained or confiscated at the European border (for background, see here). The two countries have raised this accusation several times in the TRIPS Council, although they have never gone so far as to publicly threaten to bring a WTO suit against the EU. This meeting was no exception.

A representative from the EU noted that the bloc has responded to the countries’ concerns in bilateral meetings, adding that it is imperative that customs officials be able to inspect shipments that enter European harbours.

Bolivia proposal on TRIPS and biodiversity

Turning to questions of biodiversity protection, Bolivia introduced a document (IP/C/W/545) that urges WTO members to amend the TRIPS Agreement so as to ban the patenting of all life forms. More broadly, the Bolivian submission calls for a review of TRIPS’ Article 27.3(b), the section that covers the patenting of plant and animal inventions and the protection of plant varieties. The article - which broadly outlines the inventions that governments can exclude from patenting, as well as the inventions for which they are required to make patenting an obligation - was slated for review more than ten years ago, but the review has been repeatedly pushed back.

In its submission, Bolivia described several IP-related reforms that it implemented under its new constitution, which took effect in January 2009. The changes included a new requirement that the “negotiation, signature and ratification of treaties” will be governed by principles that include a “respect for the rights of indigenous peoples and peasants,” as well as a “harmony with nature, protection of biodiversity and prohibition of private appropriation of plants, animals, micro-organisms and any living matter for exclusive use and exploitation.”

The Bolivian submission also cites the United Nations Declaration on the Rights of Indigenous Peoples, which, among other things, stipulates that the traditional knowledge of such communities should not be taken “without their free, prior and informed consent or in violation of their laws, traditions and customs.”

By adopting a ban on the patenting of all life forms, the Bolivian delegation explained, the WTO could further the rights of indigenous communities and ensure that their ‘traditional knowledge’ is not pirated by corporations from the developed world.

Currently, patent ownership is concentrated “in a few entities (largely based in developed countries),” Bolivia said in its submission, adding that this situation has “detrimental effects on competition and on social and economic situation (including food sovereignty and livelihood of farmers) that most affects the vulnerable and poor, including indigenous peoples in developing countries.”

Representatives from Cuba, Ecuador, Guatemala and Nicaragua reportedly voiced their support for Bolivia’s submission.

In other business, delegates discussed the ‘priority needs’ of Least Developed Countries, or LDCs, with regards to technical and financial cooperation on intellectual property. A TRIPS Council decision in 2005 asked the WTO’s poorest members to outline the specific types of support that they would need in order to be adequately prepared to implement a future TRIPS Agreement. Bangladesh announced at Tuesday’s meeting that it has submitted its needs assessment to the WTO. So far Uganda and Sierra Leone are the only other LDCs to have made similar submissions.

ICTSD reporting.

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