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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Pursuant to Articles L1121-1 and L1121-4 of the Public Health Code, clinical trials can be carried out if they have:
- obtained a favourable opinion from the relevant committee for the protection of persons (an ethics committee); and
- been authorised by the National Agency for Medicines and Health Products Safety (ANSM).
How robust are the standard good clinical practices followed in your jurisdiction?
The EU regulatory framework has been broadened in light of the work of the International Conference on Harmonisation, which serves as international standards. France has strictly transposed this set of regulations into national law (Decree 2006/477, dated April 26 2006, and the Decision of the ANSM on Good Clinical Practices, dated November 24 2006), which is therefore aligned with the international standards in terms of good manufacturing practices.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
In applying a former version of Article L1121-15 of the Public Health Code, the ANSM established a public register of clinical trials. Only information on biomedical research for which an application for marketing authorisation has subsequently been issued is published in the register.
While this register is still available, the Ordinance concerning Research Involving Humans (2016/800), dated June 16 2016, amended Article L1121-15 of the Public Health Code, which now provides that research involving humans and the results must be published in a public register in accordance with the decree. In that respect, the Decree concerning Research Involving Humans (2016/1537) was adopted on November 16 2016, although it provides no further clarification regarding this new version of the register for research involving humans.
What are the informed consent obligations with respect to clinical trial subjects?
Pursuant to Article L1122-1-1 of the Public Health Code, informed consent must be obtained from the subject of a trial before his or her inclusion. This includes the provision of comprehensive information on the trial, including its:
- expected benefits; and
- foreseeable constraints and risks.
Consent must be given freely and in writing. Where the person is incapable of giving written consent, it can be given by a ‘trusted person’ (Article L1111-6 of the Public Health Code) – namely, a person designated by a subject where he or she is unable to express his or her consent or the person’s legal representative or relative – on the condition that such person is independent from the investigator or sponsor.
What are the insurance requirements for clinical trials?
Pursuant to Article L1121-10 of the Public Health Code, all interventional studies require the sponsor to obtain prior insurance coverage, in order to ensure adequate compensation of damages or injuries arising from the study.
What data protection issues should be considered when conducting clinical trials?
The legal framework relating to data protection issues with respect to the conduct of clinical trials was amended by the Law on the Modernisation of the French Healthcare System (2016/41) on January 26 2016. The processing of personal data in the healthcare sector for research, study or evaluation purposes must be authorised by the National Commission of Informatics and Civil Liberties (CNIL). The CNIL must also authorise:
- research involving humans, after the relevant committee for the protection of persons (a French ethics committee) has rendered its opinion; and
studies and evaluations not involving humans, after the Expert Committee on Health Research, Study and Evaluation has given its opinion. This new committee was created by law on January 26 2016 and replaced the former Consultative Committee for the Processing of Health Research Data – 21 members were appointed to the committee following a ministerial order adopted on May 5 2017.
The CNIL can also request an opinion from the newly created National Institute of Health Data on the public interest dimension of the research, study or evaluation that requires the processing of personal data.
In order to simplify the authorisation procedure, the CNIL has issued standard methodologies. In particular, the CNIL adopted reference methodology MR-001 for interventional studies and, on July 21 2016, reference methodology MR-003 for non-interventional studies.
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