France aligns clinical trial rules with EU Clinical Trial Regulation

On 16 June 2016, Order No 2016-800 concerning research on humans was adopted in order to align the French rules on clinical trials of medicinal products with the provisions of the EU Clinical Trials Regulation (536/2014/EU), which is expected to come into force no earlier than 2018. The provisions of the Order will take effect no later than 31 December 2016, except the provisions concerned by the Regulation, which will enter into force when the corresponding provisions of the Regulation become effective.

The Order inserts a chapter on clinical trials governed by the Regulation in the Public Health Code, outlining that in accordance with the Regulation, the French National Agency for Medicines and Health Products Safety (ANSM) is responsible for the scientific/technical evaluation, while the ethics committees (Comités de protection des personnes) remain competent for the ethical assessment. The Order also coordinates the intervention of the ethics committees, providing that each of them will now be competent for the entire French territory, in contrast with their prior regional competence. The ethical assessment of clinical trials will consequently be assigned randomly to one of the ethics committees.

Other modifications include:

• Alignment of the definition of non-interventional studies with the Regulation.
• Insertion of specific provisions on patient consent which entitle: (i) researchers to continue using data that was obtained from a trial subject before withdrawing consent; and (ii) trial subjects who consented to their data being used in future scientific research to withdraw such consent.
• Extension of criminal sanctions to clinical trials with medicinal products and the introduction of a specific sanction for failure to share data required for the EU clinical trial public database.

Research that is excluded from the Regulation (mainly non-interventional studies and clinical trials that do not involve medicinal products) continues to be governed by existing French law.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, June 2016 Issue (Thomson Reuters).

This post was originally co-authored by Patricia Carmona Botana.