EU Council approves protocol amending TRIPS agreement

The Council adopted today¹ a decision accepting, on behalf of the European Community, the protocol amending the agreement on trade-related aspects of intellectual property rights (TRIPS), done at Geneva on 6 December 2005.

On 6 December 2005, the General Council of the World Trade Organisation submitted a proposed amendment to the TRIPS agreement to the WTO members for acceptance. This amendment would make permanent a waiver decision on compulsory licences originally adopted in 2003. It will enter into force once two thirds of the WTO members have accepted it. Once accepted and in force, this amendment will complete a process that began with the declaration on the TRIPS agreement and public health that ministers made at the Doha ministerial conference in November 2001.

In particular, the waiver decision of 2003 allows WTO members to export patented medicines to third countries with no manufacturing capacity in the pharmaceutical sector, by making use of compulsory licences.

The EU has been at the forefront of this initiative, since its inception in the run-up to the 2001 WTO Doha ministerial conference. Health is an essential component of the UN's millennium development goals and therefore one of the main priorities of the EU development policy. In this respect, the EU is firmly committed to ensure that in particular least-developed countries have access to essential medicines at the lowest possible prices, in particular in their fight against HIV/AIDS, tuberculosis and malaria.

It is recalled that an act implementing the 2003 WTO waiver decision in the internal legal order of the Community was adopted on 17 May 2006 (Regulation (EC) N°816/2006 of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems). Inter alia, this regulation also addresses the promotion of transfer of technology and capacity-building to countries with insufficient or no manufacturing capacity in the pharmaceutical sector, in order to facilitate and increase the production of pharmaceutical products by those countries.


¹ The decision was taken, without discussion, at the General Affairs Council meeting.

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