Trade related aspects of intellectual property rights and access to medicines

At the World Trade Organisation’s (WTO) Ministerial Meeting in Doha in November 2001, Ministers agreed on a declaration about the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement and public health. The declaration states that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health.

In March 2002, the European Communities and their Member States tabled a paper intended to help the TRIPS Council find a solution to help countries with little or no manufacturing capacity in the pharmaceutical sector, make effective use of compulsory licensing, as agreed in the declaration on TRIPS and public health.

The TRIPS Council Decision of 30 August 2003, WTO Member States agreed to allow the production of medicines under compulsory licences for export to developing countries within the terms set out in the Decision.

In December 2005, WTO Members agreed changes to the TRIPS Agreement to reflect this Decision. This General Council decision means that for the first time a core WTO agreement will be changed. This important Decision shows the willingness of Members to ensure the TRIPS Agreement does not stop Members from taking measures to protect public health.

On 1 December 2005, the European Parliament and the Council of Ministers agreed a first reading deal on a Regulation to allow the granting of compulsory licences within the European Union (EU).

This Regulation will ensure that all EU Member States have the same standards. This limits the possibility of diversion of the medicines away from their intended recipients within the EU Single Market. The Regulation was agreed by the Council on the 27 April 2006 and the European Parliament gave its assent on 24 October 2007. The EU accepted the ame ndment on 30 November 2007.

The amendment will come into force when two-thirds of WTO members have formally accepted it. The WTO General Council extended the deadline for acceptances to 31 December 2011. Until the necessary number of acceptances have been received, the Decision agreed in 2003 will remain in place.