European Parliament starts clinical trial talks; EGA chief resigns

The European Parliament is about to start discussions regarding Clinical Trials that are vital to get the best quality medicines for patients throughout the European Union. The trade group European Federation of Pharmaceutical Industries and Associations (EFPIA) says it strongly supports the efforts by the European institutions for the work they are undertaking on such an important subject.

In July 2012, the European Commission adopted a proposal for a Regulation on Clinical Trials to resolve a number of problems identified with the current legislation. In the legislative process this proposal is now subject to discussions by the European Parliament and the Council representing the 27 Member States and in parallel by all stakeholders affected by it. One of the key changes proposed concerns the assessment and decision system for clinical trial applications. In the proposal the Commission defines the regulatory environment and the objectives to be achieved. Fulfilling these requirements will need a critical review of the options for national clinical trial approval systems in the Member States and the types of collaboration between competent authorities and research ethics committees.

Richard Bergstrom, director general of EFPIA, speaking yesterday, said: “Medicines should benefit patients. We support measures that enhance the way they are used and enable the industry to continue to innovate. These measures include improved transparency. As a global industry, we are focused on working towards responsible transparency, as shown by the commitments already made. Building on these initiatives, we recognize and take seriously our responsibility to lead in advancing transparency, and propose that this needs to be part of a comprehensive initiative involving all stakeholders.”