Regulation No. 536/2014 repealed Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The main purpose of the Regulation is to harmonize and simplify the authorization procedure for trials, while maintaining stringent rules for medicinal products’ quality and safety. The entry into force of the Regulation is subject to an opinion from the European Commission, which most likely will not be issued before 2018. In anticipation of the future entry into force of the Regulation and taking into account the fact that its measures will be directly applicable and enforceable without implementation into national law, French law must be adapted to avoid any contradiction with those European provisions. The Order aims at introducing such adaptations.
Because study on medicinal products will be directly governed by the aforementioned EU Regulation, the order inserts a chapter IV in the French Public Health Code, entitled “Specific provisions applicable to clinical trials for medicinal products,” which refers to the application of this EU Regulation for these studies. Other studies shall be governed by the French law of 5 March 2012 relating to studies involving human persons, also called “Jardé Law” and whose implementing texts will be issued by the government by no later than December 2016 (the Jardé Law enters into force only when the implementation decrees are effectively adopted). The Order also adapts the definition of non-interventional studies to take into consideration the definition provided in the Regulation. Non-interventional studies are excluded from the scope of the Regulation (as well as clinical trials that do not involve medicinal products). For these studies, domestic French law rules (which have already implemented a series of EU regulations) shall be applicable.
Adaptations regarding prior authorizations for clinical trials of medicinal products
The Regulation provides that clinical trials, in order to be granted authorization before their practical implementation, must be subject to ethical and scientific reviews, whose details must be provided by each member state. The Order provides further information on the respective roles of the authorities in charge of the review of clinical trials of medicinal products in France. The review of the scientific and technical part lies with the French National Agency for Medicines and Health Products Safety (ANSM), while the ethical review shall be conducted by the committees for the protection of persons (also known as CPPs).
Criminal penalties for failure to share the data as required by the Regulation
The Order updates the French Public Health Code to adapt French criminal law provisions to the Regulation, in particular on penalties for failure to provide the data required for the European Union database. One of the innovations of the Regulation is the implementation of a European Union portal where data and information related to clinical trials (including, among others, requests for trial authorization, information on the implementation, modification, end, or suspension of the trial). This portal aims at creating an exchange platform between sponsors and authorities, and to improve transparency on clinical trials. The Regulation provides that all documents and information transferred to the portal must be archived, once the decision regarding the trial is taken, in a database accessible to the public, implemented and managed by the European Medicines Agency. The sponsor must also disclose the trial’s results to the public within a period of one year from the date of the end of the trial. The Regulation provides that failure to share data meant to be made available to the public in the EU database must be sanctioned at the member state level. The Order provides the details of this sanction, which is one year of imprisonment and a fine of up to 15,000 Euros or 75,000 Euros for legal persons.
Implementation of random selections of CPP and creation of a national secretary for CPPs
The Order prepares the implementation of random draws of CPPs and the future intervention of a national secretary for CPPs. The CPPs will no longer be competent at a regional level. CPP shall all have jurisdiction for the whole territory and will be appointed in a random manner. The manner in which such random appointments shall take place will be defined later under separate regulations.
Consent and data of persons participating to the study
The Order introduces in French law two provisions on patient consent that derive from the Regulation:
- An investigator shall have the right to continue using, in the context of his/her current study, data obtained from a trial subject before the latter decides to withdraw from the research.
- If a trial subject has given consent for use of his/her data for later studies exclusively for scientific purposes, and then withdraws that consent, the investigator shall not be able to use the data obtained from the trial subject for such later studies.
The order No. 2016-800 dated 16 June 2016 relating to study involving human persons is available here (in French).