Clinical Trials : Meps Pleased with Vote, Ngos and Industry Less So
The European Parliament's Committee on the Environment and Public Health (ENVI) enthusiastically welcomed the unanimous adoption of a report by Glenis Willmott (S&D, UK), on 29 May. This report "is a huge step forward for clinical research," welcomed shadow rapporteur Philippe Juvin (EPP, France). "It will allow important progress, such as shorter assessment timelines. Compared to our Canadian and American competitors, these timelines will be more competitive." Other groups voiced similar reactions. Michele Rivasi (Greens-EFA, France) and the rapporteur pointed out that the vote will improve data transparency while simplifying procedural rules.
MEPs voted on a regulation proposed by the European Commission, on 17 July, repealing Directive 2001/20/EC, unanimously found to be unsatisfactory. The text is meant to give fresh impetus to clinical research in Europe by simplifying procedures and differentiating trials in terms of risks.
The European Consumers' Organisation (BEUC) acknowledges the advances made possible with the adoption of amendments, but finds that the enthusiasm needs to be tempered. "The negotiations with the Council are going to be tough," explained BEUC's Senior Health Policy Officer Ilaria Passarani, particularly as there is great pressure from pharmaceutical firms. BEUC regrets the rejection of a consolidated amendment to Article 78 by the Greens, S&D and GUE groups, stating that information and data from clinical study reports may not be considered as commercially confidential once marketing authorisation has been issued. …