establishing the position to be taken on behalf of the European Union within the Council for TRIPS and the General Council of the World Trade Organisation as regards the request from least developed country members for an extension of the transitional period under Article 66(1) of the Agreement on Trade Related Aspects of Intellectual Property Rights concerning certain obligations related to pharmaceutical products, and for a waiver from the obligations under Article 70(8) and (9) of that Agreement

EXPLANATORY MEMORANDUM

1.CONTEXT OF THE PROPOSAL

•Reasons for and objectives of the proposal

The objective of this proposal is to allow the European Union to join a consensus in the World Trade Organisation (WTO) on the adoption of two decisions.

First, a decision granting an extension for least developed countries (LDCs) of the Transition Period under Article 66.1 of the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) for certain obligations with respect to pharmaceutical products for as long as they remain least developed countries.

Second a decision granting a waiver from obligations with respect to pharmaceutical products under Article 70.8 and Article 70.9 of that Agreement for least developed countries for as long as they remain least developed countries.

The extension and the waiver are due to expire on 1 January 2016. Bangladesh on 23 February 2015 on behalf of the least-developed country Members requested an indefinite extension of the Transition Period under Article 66.1 from TRIPS and an indefinite waiver from obligations under Article 70.8 and Article 70.9 with respect to pharmaceutical products for as long as they remain least developed countries.

The proposal provides that the Council authorises the Commission to take a position on behalf of the European Union within the WTO to join a consensus as regards the said decisions.

•Consistency with existing policy provisions in the policy area

The initiative is fully consistent with existing policy provisions. Similar decisions have been adopted previously.

The European Union supported the Doha Declaration on TRIPS and Public Health of 14 November 2001 in which it was agreed that the least-developed country Members would not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016, without prejudice to the right of least-developed country Members to seek other extensions of the transition periods as provided for in Article 66.1 of the TRIPS Agreement, and the Council for TRIPS was instructed to take the necessary action to give effect to this pursuant to Article 66.1 of the TRIPS Agreement (WTO document WT/MIN(01)/DEC/2).

The European Union supported the Council for TRIPS Decision of 27 June 2002 under Article 66.1 TRIPS which extended the Transition Period during which least-developed countries do not have to provide patent protection for pharmaceuticals products until 1 January 2016 (WTO document IP/C/25).

The European Union supported the related Decision by the WTO General Council on 8 July 2002, giving least-developed countries a waiver from granting exclusive marketing rights under Article 70.9 of the TRIPS Agreement until 1 January 2016 (WTO document WT/L/478).

The European Union also supported extending the general transition period, agreed by WTO members on 11 June 2013, for least-developed countries to apply TRIPS provisions until 1 July 2021 (WTO document IP/C/64).

•Consistency with other Union policies

The initiative is fully consistent with European Union policies. It is coherent with the EU's global health policy as defined in the Commission Communication on Global Health and its objective to keep essential medicines accessible and affordable in line with the Doha Declaration (COM (2010) 128 Brussels). It is coherent with other actions to promote access to medicines for all as noted in the EU 2013 Report on Policy Coherence for Development (SWD (2013) 456 final).

2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

•Legal basis

Article 218(9) of the Treaty on the Functioning of the European Union (TFEU) provides that when a Decision having legal effects needs to be taken in a body set up by an international agreement, the Council, on a proposal from the Commission or the High Representative of the Union for Foreign Affairs and Security Policy, shall adopt a Decision establishing the position to be adopted on the Union’s behalf.