On 19 December 2012, the European Data Protection Supervisor (EDPS) and the Assistant Supervisor, M. Giovanni Buttarelli, published a new Opinion that sets out their views on the Commission proposal for a new Regulation on Clinical Trials on Medicinal Products for Human Use (the Regulation). The Commission proposal, released in July 2012, touches on a variety of data protection issues, ranging from the legal basis that clinical research organisations (CROs) must rely on when processing sensitive health data gathered in clinical trials to the establishment of a centralized database at the European Medicines Agency (EMA) that is intended to store records of clinical investigators and adverse event reports from across Europe.
In general, the EDPS appears to have welcomed the Commission’s approach; apparently, the Commission draft was altered to adapt to early informal EDPS criticisms, and so already contains provisions that are relatively sensitive to data privacy concerns. Perhaps surprisingly, the EDPS also refrains from commenting extensively on the Regulation’s approach to the issue of how clinical trial participants may provide informed consent to their participation in the trial. However, the EDPS nevertheless does make a number of suggestions about how the draft Regulation should be further modified. We discuss the particular suggestions after the jump.
Continue Reading EDPS Suggests Amendments to the Commission Proposal for a new Regulation on Clinical Trials on Medicinal Products for Human Use