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BioIndustry Association Release: Political Agreement On EU Clinical Trial Regulation Simplifies Rules But Misses Its Initial Goal


12/20/2013 10:51:32 AM

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20 December 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 authorisation 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 authorisation 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 Harmonisation 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 today is subject to technical finalisation and formal approval by the European Parliament at Plenary and by the Council.

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

European Commission press release: http://europa.eu/!Qt39uw

Lithuanian EU Council Presidency press release: http://www.eu2013.lt/en/news/pressreleases/agreement-on-clinical-trials-major-step-towards-innovative-and-competitive-europe

Council of the European Union press release:

http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/140241.pdf

July 2012 European Commission press release: http://ec.europa.eu/health/files/clinicaltrials/2012_07/press-releases/ip-12-795_en.pdf

October 2012 press release from Glenis Willmott: http://www.gleniswillmott.eu/labour-mep-to-lead-on-clinical-trials-rethink/

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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