EPF responded to the Commission’s public consultation on the Clinical Trials Directive – Directive 2001/20/EC – in January 2009.
The Directive is coming up for review in 2011, and EPF is contributing actively in this process. The European Commission published a concept paper to outline options for revising the Directive, and launched a second public consultation to which EPF responded in May 2011. EPF also submitted a statement to raise again fundamental issues which were not addressed in the concept paper. We will continue to provide a strong patients’ voice in this review, as we believe this is an opportunity for reform towards more patients’ involvement throughout the research process, greater trust and confidence in medical research, and improved participation rates.
EPF has long called for greater transparency around clinical research, including information about clinical trials taking place across the EU. In March 2011 we welcomed the launch of the EU Clinical Trial Register. We will continue to support the European Medicines Agency through the Patients' and Consumers' Working Party, to ensure that the Register is developed further to meet the practical needs of patients.
We are also actively involved in a working group at the European Medicines Agency on the application of ethical and good clinical practice (GDP) standards in third-country clinical trials, in the context of EU marketing authorisation applications.
To review our position, please consult the related documents section to your right.
Last modified: 14th September 2011
EPF Statement Clinical Trials (May 2011)
EPF response to the Clinical Trials consultation (January 2009)