9.6.2006 Official Journal of the European Union L157/1 (Acts whose publication is obligatory) REGULATION (EC) No 816/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO- PEAN UNION, Having regard to the Treaty establishing the European Com- munity, and in particular Articles 95 and 133 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (%), Acting in accordance with the procedure laid down in Article 251 of the Treaty (), Whereas: (1) On 14 November 2001 the Fourth Ministerial Confer- ence of the World Trade Organisation (WTO) adopted the Doha Declaration on the Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS Agreement) and Public Health. The Declaration recog- nises that each WTO Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. It also recognises that WTO Members with insufficient or no manufacturing capacity in the pharmaceutical sector could face difficulties in making effective use of compul- sory licensing. On 30 August 2003 the WTO General Council, in the light of the statement read out by its Chairman, adopted the Decision on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (the Decision). Subject to certain condi- tions, the Decision waives certain obligations concerning the issue of compulsory licences set out in the TRIPS Agreement in order to address the needs of WTO Members with insufficient manufacturing capacity. () OJ C 286, 17.11.2005, p. 4. (*) Opinion of the Euro]pean Parliament of 1.12.2005 (not yet published in the Officia 2006. Journal), and Council Decision of 28 April G) Given the Community’s active role in the adoption of the Decision, its commitment made to the WTO to fully contribute to the implementation of the Decision and its appeal to all WTO Members to ensure that the condi- tions are put in place which will allow the system set up by the Decision to operate efficiently, it is important for the Community to implement the Decision in its legal order. Uniform implementation of the Decision is needed to ensure that the conditions for the granting of compul- sory licences for the manufacture and sale of pharma- ceutical products, when such products are intended for export, are the same in all Member States and to avoid distortion of competition for operators in the single market. Uniform rules should also be applied to prevent re-importation into the territory of the Community of pharmaceutical products manufactured pursuant to the Decision. This Regulation is intended to be part of wider European and international action to address public health problems faced by least developed countries and other developing countries, and in particular to improve access to affordable medicines which are safe and effec- tive, including fixed-dose combinations, and whose quality is guaranteed. In that connection, the procedures laid down in Community pharmaceutical legislation guaranteeing the scientific quality of such products will be available, in particular that provided for in Article 58 of Regulation (EC) No 726/2004 of the European Parlia- ment and of the Council of 31 March 2004 laying down Community procedures for the authorisation and super- vision of medicinal products for human and veterinary use and establishing a European Medicines Agency (°). As the compulsory licensing system set up by this Regu- lation is intended to address public health problems, it should be used in good faith. This system should not be used by countries to pursue industrial or commercial policy objectives. This Regulation is designed to create a secure legal framework and to discourage litigation. () OJ L 136, 30.4.2004, p. 1.