John Gormley (Dublin South East, Green Party)
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Question 148: To ask the Minister for Enterprise, Trade and Employment the action, as a member of the WTO, he is taking in order to protect developing countries from large pharmaceutical companies challenging their patent laws, undermining TRIPS safeguards and preventing access to inexpensive versions of patented medicines in developing countries; and if he will make a statement on the matter. [2722/07]

Paul Gogarty (Dublin Mid West, Green Party)
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Question 174: To ask the Minister for Enterprise, Trade and Employment the measures he is taking, in view of his commitments under the Doha Declaration, to support developing countries in implementing trade related aspects of intellectual property rights safeguards in order to protect public health and ensure access to affordable medicine. [2728/07]

Michael Ahern (Cork East, Fianna Fail)
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I propose to take Questions Nos. 148 and 174 together.

The EU and its member states have played an influential and active central role in various initiatives in this field over recent years such as the adoption of the WTO General Council Decision in August 2003 which waived WTO members' obligations under the TRIPs Agreement. That waiver allowed WTO member countries to grant compulsory licences for the production and sale of patented pharmaceutical products intended for export to third countries lacking pharmaceutical manufacturing capacity to meet their needs.

The temporary 2003 waiver was then copper-fastened by the WTO General Council decision in December 2005 proposing a permanent amendment to the TRIPs Agreement in this regard. WTO procedure required that to be submitted to its member countries for their acceptance.

Over this period the European Community also acted on the TRIPs waiver approach in adopting Regulation (EC) No. 816/2006 of the European Parliament and of the Council of 17 May 2006. That regulation on the compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, came into force on 29th June 2006. It now provides a legally secure, predictable, effective and sustainable solution for those members of the WTO and other least developed and developing countries, which want to use the licensing system to access the affordable medicines that they may need.