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FEAM Statement on Reform of EU Clinical Trials Directive

"Taking forward reform of the EU Clincal Trials Directive"


Implementation of the Clinical Trials Directive (CTD), intended to harmonise authorisation of EU clinical trials on medical products, has been controversial. The accumulating evidence shows that the CTD has deterred academic clinical research. Following publication of the Federation of the European Academies of Medicine (FEAM) Statement: "Opportunities and Challenges for Reforming the EU Clinical Trials Directive: an Academic Perspective" in in 2010, FEAM organised a discussion event in the European Parliament on 25 January 2011 to engage stakeholders from academia, industry, other research bodies and patient interest groups with representatives from the European Commission and Parliament. The objectives were to share perspectives on the key issues and explore options for change.

Professor János Frühlin (FEAM) provided background information on the goals and practices of FEAM, which brings together the national Academies to advise the political and administrative authorities of the EU on matters concerning medicine and public health. FEAM has a very active and wide-ranging programme of work: in addition to the CTD initiative, FEAM is currently engaged in activities on mental health policy, genetic testing and personalised medicine, human and animal infectious disease, and medical education, in part in cooperation with the European Academies Science Advisory Council (EASAC).


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