European Union (EU) regulators today reached agreement on the much-vaunted Clinical Trials Regulation. The regulation harmonizes the rules for the conduct of clinical trials in the EU and the ‘acceptability’ of the resulting data, and places further safeguards on the safety of trial subjects. The legislation’s aim is to facilitate and expedite the authorization procedure for clinical trials and increase the number of trials conducted in the EU.
But while broadly welcoming the agreement, industry is concerned that the rules are not ambitious enough.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) called it a “positive step towards restoring European competitiveness in clinical research” and applauded the move towards enchanced transparency and the protection of personal patient data and commercially-sensitive information
But the UK’s BioIndustry Association (BIA) Chief Executive Officer Steve Bates said that extending the timelines for approval “fails to improve the attractiveness of Europe and the UK as a location for global clinical trials… UK patients stand to miss out on the chance to participate in developing the therapies of the future.”
The European Association for Bioindustries (EuropaBio) believed that “the compromise text agreed by member states today is not ambitious enough to meet the objective of securing timely patient access to innovative treatments and improving the attractiveness of Europe in terms of clinical research, and thus contributing to the growth objective of the Europe 2020 Strategy.”
EuropaBio pointed out that, including the timelines for questions and assessment of responses, total assessment timelines would actually be nearer to or in many cases exceed 100 days. Miriam Gargesi, Director of Healthcare, added that “the Regulation should be carefully implemented so as not to jeopardise companies’ innovation potential and as patients’ timely access to innovative medicines.”