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AM: The first European initiative in the field of rare diseases was the Decision No 1295/1999/EC of the European Parliament and of the Council adopting a programme of Community action on rare diseases within the framework for action in the field of public health (1999 to 2003). This was not a real programme of action but a funding instrument giving to the different stakeholders the first opportunity to create EU collaborations and networks (the database Orphanet constitutes the best example). In 2000 the Commission adopted the Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products which introduced for the first time a European definition on rare diseases, any disease having a prevalence of less than 5 per 10 000 of population, but obviously focusing on incentives to pharma companies to research and develop drugs not having economic return. At the same time the Framework Programme on research, FP5, launched also initiatives on rare diseases research very significant in terms of impact. During these years before 1999 still end 2003 the different actions of the EU lacked of a public health orientation and appropriate coordination. Things started to change in 2004 after adoption of the First European Public Health Programme (2003-2007) and the Sixth Framework Programme (2003-2007). Rare diseases become a strategical objective in the EU public health and research policies and consultative structures, at EU level, were created for the first time. The EU Task Force on Rare Diseases was created in 2004 and has given a significant input to the EU in terms of impulse and help to refine European cooperation in the field of rare diseases. In 2008 the European Commission decided to adopt the Commission Communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Rare Diseases: Europe’s challenges and to propose to the Council the adoption, finally done in 2009, of the Council Recommendation on an action in the field of rare diseases. After adoption of both documents the EU had, finally, a coherent framework of activities shared by the European Commission and the Member States. The adoption of the Commission Decision of 30th November 2009, establishing a European Union Committee of Experts on Rare Diseases, permitted to create a large structure where al the stakeholders (Member States, Patient’s organisations, Industry, Research community, Public He
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