Ms. Glenis Willmott MEP (S&D, UK), rapporteur for Clinical Trials Regulation in the European Parliament’s lead Committee of the Environment, Public Health and Food Safety Committee (ENVI), has published her draft report on this dossier.
The proposal for a Clinical Trials Regulation aims to address the problem of a declining number of clinical trials in Europe. The Regulation replaces the existing Directive which involved a patchwork of different regulatory systems throughout the EU. The proposed Regulation would create a single regulatory system for the entire EU.
Ms. Glenis Willmott’s report would form the basis of the European Parliament’s position on this proposal.
The draft report is very much in accordance with the proposal by the Commission and a large number of changes put forward to the proposal should mostly be seen as clarifications of unclear formulations by the Commission. Transparency of clinical trials data and clinical trials assessment by ethics committees were expected to be the main focus of the report, due to these having been discussed intensely during events and in informal settings, and as expected Ms. Willmott has put forward a number of amendments addressing these topics.
The key focus of her report however is on transparency. The debate in Parliament is currently focused on the level of data that should be made publically accessible with a growing consensus at Committee level that the results of clinical trials should be published regardless of whether the trails produced a positive or negative result.
Amendments to this report are currently being gathered and they will be considered on the 20 and 21 March 2013.
A vote on the report will take place in the ENVI Committee on 24 or 25 April 2013 with a final vote of the Parliament expected on 10 June 2013.