title: [Faecal microbiota transplantation in France: what applicable law?].
abstract: The transplantation of gut microbiota addresses a critical gap in the treatment of recurrent severe Clostridium difficile infection, and clinical trials are ongoing throughout the world for other potential broader clinical indications. As the fecal flora inoculum has currently no legal status under European law, we consider it provisionally a sui generis biological drug rather than a human tissue transplantation, with major implications in terms of legal liability in France. The inoculum obeys a derogation to the pharmaceutical preparation rules, is processed under microbiological control, and therefore should carry a special obligation for informed consent from recipients. Failing industrializable solutions to date, this practice for the modulation of human microbiome suggests that the current legal definition of the biologic drug as well as the rules for donation and use of human-originated substances should be complemented. A new category of therapeutic products could be considered in European law, unless a rapid technological progress (the French Agency ASNM classified FMT as a drug in March 2014).
authors.affiliation: Service de droit et d'économie de la santé, faculté des sciences pharmaceutiques et biologiques, université Paris Descartes, 4, avenue de l'Observatoire, 75006 Paris, France; Berkeley center for health technology, university of California, Berkeley, États-Unis; GRADES université Paris Sud, 5, rue Jean-Baptiste-Clément, 92296 Châtenay-Malabry cedex, France; Académie nationale de pharmacie, 4, avenue de l'Observatoire, 75006 Paris, France. Electronic address: francis.megerlin@parisdescartes.fr.
authors.forename: F
authors.initials: F
authors.lastname: Megerlin
authors.affiliation: GRADES université Paris Sud, 5, rue Jean-Baptiste-Clément, 92296 Châtenay-Malabry cedex, France; Académie nationale de pharmacie, 4, avenue de l'Observatoire, 75006 Paris, France.
authors.forename: E
authors.initials: E
authors.lastname: Fouassier
mesh_terms: D016360:Clostridioides difficile; D004761:Enterocolitis, Pseudomembranous / Q000382:microbiology / Q000628:therapy; D000069467:Fecal Microbiota Transplantation; D005243:Feces / Q000382:microbiology*; D005602:France; D000069196:Gastrointestinal Microbiome; D006801:Humans; D007883:Legislation, Medical
keywords: Droit; Drug; Ethics; Fecal microbiota transplantation; French law; Liability; Microbiome; Médicament; Responsabilité; Tissu; Tissue; Transfert de flore intestinale; Éthique