The French legislator recently updated the French clinical trial agreement template also called “clinical trial sole agreement” (“convention unique”), through the publication of the Order dated of 28 March 2022.
The English version of this new template agreement has been translated and was made available in September 2022 on the Ministry of Health website.
Legal context in France
France has a special system where a standard CTA template is imposed by the French government in the context of any clinical research involving the human person in France. Initially introduced by the National Health Law of 26 January 2016, this mandatory standard contract template must be used between the sponsor and healthcare establishments, care homes or health centers and cannot be amended.
Changes resulting from the update of the sole agreement template
The updated version of the template has been a long time coming, in particular since the previous version of the standard template was not compliant with the GDPR requirements. The new template agreement published by the French government on 9 April 2022 (which entered into force on 10 April 2022), implemented several changes including data protection-related provisions and an Annex 3 dedicated to the mandatory provisions of article 28 of GDPR. Until now, companies were forced to sign non-compliant agreements since the terms of the template could not be negotiated or modified.
Other changes include the update of regulatory and legislative references, the revaluation of medical services, or the possibility to sign electronic versions of the sole agreement.
Agreements concluded prior to 10 April 2022
Clinical trial agreements concluded prior to the publication of this order remain applicable. The use of the new template agreement is only mandatory as of 10 April 2022 meaning that agreements concluded before this date according to the previous template remain in force.
Some difficulties might subsist especially regarding data protection as the new template agreement does not include provisions regarding data transfer outside the EU. More generally, difficulties might be caused by the rigidity of the framework which remains as the provisions of the new template still cannot be modified by the parties.