Clinical Trials: we must save European clinical research!

The Environment, Public Health and Food Safety Committee of the European Parliament today adopted a Report on clinical trials on medicinal products for human use, by a large majority.

Philippe Juvin, EPP Group spokesman on the dossier, welcomed the adoption of the Report: "I have been working on and have been committed to this dossier for two years. We urgently need to review Directive 2001/20/EC. Indeed, European clinical research is dying: there is a decrease of 25% of clinical trial applications from 2007 to 2010, a steady fall in the number of patients involved in the clinical trials, red tape and an increase in costs for applications and conducting clinical trials. These dysfunctions dissuade academics and incite sponsors to outsource their clinical studies more and more. They are prejudicial on one hand for European clinical research and the attractiveness of our universities, and on the other, for the European patients who have the right to benefit from the best treatments."

"This Report is a huge step forward for European clinical research. It will allow important progress, such as shorter assessment timelines. Compared to our Canadian and American competitors, these timelines will be more competitive. Then, the Regulation will finally cover the emergency clinical trials. This category has been covered by American law since 1996 and by French law since 1988", underlined the MEP.

"Finally, one of the big issues of this Regulation is transparency of the clinical trials’ results. From now on, all of the positive and negative results will be published within a summary one year after the end of the trials or the inclusion of the last participant. The sponsors will have to publish a clinical study report 30 days after the decision on the marketing authorisation. This is a real reasonable and balanced position, which aims to guarantee a high level of transparency and safety for European patients".

"The negotiations with my fellow Rapporteurs from the other political groups were very useful and were conducted in a serene atmosphere. We all have a common objective: to save European clinical research!", concluded Juvin.