EU Clinical Trials Regulation must put all EU patients first, says BIA

Commenting in advance of the European Union Committee of Permanent Representatives (COREPER) agreement on Friday (December 20) on the final compromise text of the Clinical Trials Regulation, Steve Bates, BioIndustry Association (BIA) chief executive expressed reservations about what this might contain.

He said: "The EU Clinical Trials Regulation must deliver what it set out to do: provide a simplified and efficient regulatory framework for clinical trials in the EU. The BIA calls for the Permanent Representatives to take this into account tomorrow.”

Mr Bates continued: "Such a simplified regulatory system in the EU will allow patients timely access to innovative treatments, reduce the administrative burden and costs for public and private sector researchers as well as for EU member states, and improve Europe's attractiveness as a global location for the research and development of new medicines. I fear that the political compromises in this package will do nothing to make the EU a more attractive place to conduct clinical trials - which was an initial goal of this Regulation."

Clinical trial authorization process needs streamlining

Alan Morrison, chairman of the BIA Regulatory Affairs Advisory Committee, added: "Of particular importance is the need to ensure that the authorization process for a clinical trial is streamlined. The timelines from submission to decision should not be lengthened unnecessarily as this may dilute the many potential positive impacts of the proposed EU Clinical Trials Regulation.”

Moreover, he noted: "Reports that the timeframe for decisions could be extended to over 100 days, which is a worse position than the UK consistently achieves at present, means that other EU countries may be able to delay decision making and could slow down the process for multinational trials. This could make the EU a less attractive place for conducting clinical research in future. The decision by policy makers to put in place practical checkpoints to ensure the Regulation only becomes applicable if the crucial IT system is functional is to be welcomed."