Key stakeholders gathered in the European Parliament yesterday to debate proposals on improving the clinical trials framework in Europe. At an event hosted by MEP Prof. Philippe Juvin and organised by EuropaBio, experts from patient groups, industry, academia, regulatory agencies, ethics committees and EU institutions gathered to further discuss ways to move forward in the upcoming revision of the Clinical Trials Directive and to present their respective proposals for the revision.  Experts believe that a review of the current legislation will greatly benefit patients by improving the development of and access to innovative medicines while contributing to the goals of the EU 2020 strategy.

Central to the discussions were proposals to simplify current procedures as well as streamlining the trial approval process.  EuropaBio believes that a harmonized content of the Clinical Trial application dossier, a scientific and ethical assessment and a single outcome is needed across all EU Member States to conduct innovative trials that benefit patients throughout the Union. Currently of the more than 650 biotechnological medicines undergoing clinical trials, many are produced by SMEs, which feel the administrative burden of the diverse implementation by Member States of the current rules even more acutely than larger pharmaceutical firms.  Many of these clinical trials need to take place in numerous locations, therefore it is essential that extending clinical trials to multiple Member States does not trigger a costly and burdensome repetition of the scientific assessments by the different regulatory authorities.

Dr. Christiane Abouzeid, Head of Regulatory Affairs, BioIndustry Association (BIA) and topic leader for Clinical Trials at EuropaBio gave her expert opinion during the event.  She emphasised the need for Europe to become a more attractive place for clinical research and development of new and innovative medicines.  In order for this to be achieved, the current legislation on clinical trials needs to be modified to reduce administrative burdens across Member States, reducing costs for public and private sector researchers and ultimately speeding the time it takes for life-saving medication to reach patients.  She stated: “Increased innovation in medicines needs the correct legislation in place so that procedures to bring medicines to the market are simplified.  An open and informed debate on a new framework for clinical trials in Europe is necessary so that we can achieve better outcomes for patients, and further develop the knowledge-based economy in Europe”.

~ENDS~

About EuropaBio (the European Association for Bioindustries): EuropaBio's, mission is to promote an innovative and dynamic biotechnology based industry in Europe. Founded in 1996, to provide a voice for the biotech industry at an EU level, EuropaBio represents corporate and associate members operating worldwide, as well as bioregions and national biotechnology associations representing some 1800 SMEs.

For further information please contact:

Rosalind Travers

Communications and Associations Liaison Officer

Tel: +32 2 739 1173

Mobile: +32 478 680 301

Email: r.travers@europabio.org

Or

Ludovic Lacaine

Director, Healthcare Biotechnology

Tel: +32 739 1183

Email: l.lacaine@europabio.org