New French Decree Clarifies the Scope of Biomedical Research, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

Jones Day

French Decree n° 2017-884 of May 9, 2017, was adopted to implement certain provisions of the Legal Ordinance of June 16, 2016, with respect to biomedical research. Such research should now be referred to as "research involving human subjects" (recherches impliquant la personne humaine or "RIPH"). The new decree defines the scope of RIPH as investigations organized and carried out on willing participants, in the context of developing biological or medical knowledge.

More specifically, RIPH may include investigations regarding: (i) functioning mechanisms of a human organism (whether normal or pathological); or (ii) the efficiency and safety of actions undertaken, or the use of products for the purposes of diagnostic, treatment, or prevention of a pathological state. Investigations regarding cosmetic products, even if carried out on normal or pathological human subjects, do not qualify as RIPH as long as the purpose of such research is to test the product's capability to clean, perfume, change the appearance of human bodies, correct body odors, and/or protect human bodies.

Additionally, research that includes only a satisfaction survey regarding cosmetic or food products, any other type of satisfaction survey among patients, or experimentations in human or social science in the health field should not be considered RIPH. It should be noted that such definition seems to contradict the terms of a ministerial order dated May 3, 2017. The Order states that noninterventional RIPH on cosmetic or food products does not require the opinion of an ethics committee, nor does it require registration if such investigation includes only interviews or surveys regarding the subject's feelings about the efficiency or tolerance of the product.

The Decree of May 9, 2017, also creates a reduced application file for any noninterventional research that includes only interviews or surveys (on other products than cosmetics or food, as mentioned above). Such provision is mainly designed to facilitate thesis or research memos by health professional students, but it may also benefit the industry.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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