Political Agreement on EU Clinical Trial Regulation Simplifies Rules But Misses its Initial Goal
News Dec 23, 2013
Today's endorsement by the EU Committee of Permanent Representatives of the political agreement reached by the Lithuanian EU Council Presidency and the European Parliament, on the compromise text of the proposed EU Clinical Trials Regulation looks set to not deliver on the initial goal, set by the European Commission when it launched the process in July 2012, of making the EU a more attractive location to conduct clinical trials.
Steve Bates, BioIndustry Association (BIA) Chief Executive Officer, said: "Today's deal marks a milestone in simplifying the rules for conducting clinical trials in the EU. But, even the European Commission conceded today that it had hoped for a more ambitious approach in line with its original proposal.
"I fear that the compromise in extending the timelines for approval fails to improve the attractiveness of Europe and the UK as a location for global clinical trials. This means UK patients stand to miss out on the chance to participate in developing the therapies of the future.
"In particular increasing the timeline to over 100 days for clinical trial approvals for advanced and innovative therapies is unlikely to boost clinical research in the EU. I fear this will result in a worse position for researchers in innovative bioscience companies, medical research charities and in hospitals and academia who are developing innovative treatments, than the UK consistently achieves at present.
"This key compromise makes it harder, not easier, to deliver on the initial goal of this piece of legislation which UK MEP Glenis Willmott, the European Parliament rapporteur, defined as 'creating many skilled jobs in the UK and Europe, as well as leading to new life-saving treatments and drugs'."
However the BIA welcomes a number of the positive measures outlined in the new rules on conducting clinical trials in the EU, including:
• A streamlined application procedure via a single entry point for all clinical trials conducted in Europe
• A single authorization procedure for all clinical trials with a single decision per Member State encompassing both the regulatory and ethical/local aspects of a clinical trial assessment
• The extension of the tacit agreement principle to the whole authorization process which will give sponsors and researchers, in particular SMEs and academics, more legal certainty
• Improved conditions for conducting multinational clinical trials, which puts the Voluntary Harmonization Procedure on a legal basis
• Strengthened rules on the protection of patients and informed consent
• More transparency on the conduct and results of the clinical trial
The political agreement reached is subject to technical finalization and formal approval by the European Parliament at Plenary and by the Council.