New rules on clinical trials were published in the Official Journal on 17 November 2016, in a response to the therapeutic accident in Rennes, and also as signal of support to the sector so that this event does not result in a renunciation of research. “In order to support innovation in France, we simplify and safeguard the rules of clinical trials, and this is the purpose of the two decrees. Research or the hospitals carrying out the tests are too long, and the rules too restrictive” explains Minister of Health, Ms Marisol Touraine. The single convention introduced in 2014 thus becomes “compulsory for all establishments and must be concluded in less than 60 days. This agreement will also be based on a single model”.
Several measures have also been taken to enhance the safety of volunteers participating in clinical trials. The independence of the committees for the protection of persons is thus ensured by a decree. “Until then the committee of the region was systematically seized: henceforth, the designation will be made by drawing lots at the national level,” explains Marisol Touraine. This reform “should make it possible to re-establish the necessary critical distance, where privileged relations have been established over time in certain regions with promoters”. When questioned about possible shortcomings of the ANSM, the minister assured that she had no evidence against the Health Authority.
Source: Le Monde – Le Quotidien du Medecin.