BioIndustry Association Release: EU Clinical Trials Regulation Must Put All EU Patients First

19 December 2013 -- Commenting in advance of the EU Committee of Permanent Representatives (COREPER) agreement on Friday 20 December 2013 on the final compromise text of the Clinical Trials Regulation, Steve Bates, BioIndustry Association (BIA) Chief Executive Officer, 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.

"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."

Alan Morrison, Chair of the BIA Regulatory Affairs Advisory Committee, said:

"Of particular importance is the need to ensure that the authorisation 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.

"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."

For further information, please contact Robert Winder, Head of Communications, rwinder@bioindustry.org, 020 7630 2191; mobile 07825 942 934.

BioIndustry Association

Founded over 20 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives. For further information, please go to www.bioindustry.org

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