CLINICAL TRIALS : MEPS PLEASED WITH VOTE, NGOS AND INDUSTRY LESS SO
5 June 2013
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. Michèle 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.
In spite of rejection of that amendment, Parliament's left wing is reassured by the adoption of a recital that includes the same provisions, adopted with ALDE support. NGOs are nevertheless concerned that Parliament's voice may not carry much weight with member states in defending a recital (having less legal force) adopted by a slim margin and not matched with an article in the regulation.
The industry has expressed concerns. EFPIA, the European Federation of Pharmaceutical Industries and Associations, finds that ENVI's approach is “unbalanced” on data confidentiality. The vote “will jeopardise patient privacy, the integrity of regulatory systems and incentives for investment in biomedical research in Europe”.
The Standing Committee of European Doctors welcomes the clarifications on ethics committees, enhanced protection of vulnerable individuals, provisions on transparency of results and improvements to rules on informed consent. Doctors, on the other hand, are very concerned about derogations to informed consent for large-scale and low-risk clinical trials.