In France, the conduct of clinical trials requires a prior express favourable opinion of a Comité de protection des personnes (CPP), in English Committee for the protection of the persons.
Save for low intervention clinical trials where the CPPs assess both aspects, the assessment of the CPP covers the ethical aspects of the clinical trial project, while the scientific assessment is conducted by the ANSM (French medicines agency).
Since a law of 2012, implemented in November 2016, competent CPPs have been designated randomly, by means of a draw. The introduction of a random designation was aimed at avoiding “proximity” between sponsors and given CPPs, and resulting risks of conflicts of interests.
However, the random designation triggered difficulties and delays. It did not take into account the workload of the CPPs or the skills of their members. This could prove problematic when regulations require specific skills for the assessment of certain research projects (e.g. in case of research pertaining to the first administration of a health product to humans or research involving less than 16 years old minors).
This issue is addressed by a law of October 17, 2018 which amends Article L. 1123-6 of the Public Health Code governing the designation process of the competent CPP for a given research project.
This article now provides that the random designation of the CPP will take place only among the CPPs "available and having the required competence necessary for the assessment of the project".
Thus, while keeping the principle of random designation, this new law improves efficiency of the process by ensuring that it will take place among the CPPs having both availability and required competencies.
This new law was adopted with due regard to the entry into force in 2020 of Regulation n° 536/2014 on clinical trials for drugs providing that, in the absence of decision within the required time-limit, the opinion of the ethical committee will be deemed favourable.
The French legislator wants to ensure that the French ethical committees will be able to give their opinion in due time and that no clinical trial will be conducted without a proper assessment and favourable opinion.