[Faecal microbiota transplantation in France: what applicable law?]. / Le transfert de microbiote intestinal à finalité thérapeutique : quel droit applicable en France ?

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).

Faecal microbiota transplantation: a sui generis biological drug, not a tissue.

Responding to Smith et al. (Nature, 2014), this paper argues that for medical use, faecal microbiota transplantation (FMT) should be considered a sui generis biological drug, rather than a tissue. Smith and colleagues' thesis is based on possible undesirable economic consequences of this designation--not on its scientific and conceptual basis. The faecal transplant (including gut microbiota, metabolites, mucus, human cells, viruses, fungi, etc.) is not a tissue; it is of topographic--not cellular--human origin. We consider the donor a bioreactor, producing the faecal substrate of therapeutic interest. The debate is of singular importance as the FDA considers FMT a drug and released a new guidance for public consultation in February 2014, whereas to date the European Medicines Agency has not promulgated its position. The UK's National Institute for Heath and Care Excellence does not consider FMT to involve the transplantation of body tissue, and in March 2014 the French regulatory agency ANSM expressly declared it to be a drug. As FM is a complex and highly variable admixture, its components cannot be completely characterized, and to date, compositional quality cannot be assessed. We consider FMT to be a sui generis biologic drug, albeit one prepared with unconventional raw material under microbiologic control. The possibility of associating identified bacterial species with particular diseases and cultivating selected bacteria of therapeutic interest would certainly define a second generation of microbiome therapeutics, but is still speculative.

[Dispensing of medicines in nursing homes for frail elderly: what role for mutualistic pharmacists?]. / La dispensation des médicaments en EHPAD : quelle place pour les pharmaciens mutualistes ?

According to articles L.5126-6-1 and L.5125-5-1 A in the code of public health, pharmacists can act in two different functions in nursing homes for frail elderly: pharmacist provider and/or pharmacist referent. The issue of access to these functions remained open for mutual pharmacists. With regard to their specific applicable legal regulations, arguments do exist questioning the possibility for mutual pharmacies of entering in the organization of the nursing home pharmacy provider. In addition, it appears that mutual pharmacists could exercise the duties of pharmacist referent only in nursing homes that refer to mutual residents.

[The illegal exercise of pharmacy during the XIXth century]. / L'Exercice illégal de la pharmacie au XIX Siècle.

During the XIXth century, the courts judged many cases of illegal exercise of pharmacy. The persons concerned were doctors, members of clergy, grocers, quacks... The writer analyses many decisions and shows the importance of the jurisprudence as a source of the right during this century.

[Sherlock Holmes, Watson and cocaine. A literary contribution to the history of drug addiction]. / Sherlock Holmes, Watson et la cocaïne. Une contribution littéraire à l'histoire des toxicomanies.

From 1887 to 1927, Conan Doyle devoted fifty-six short stories and four novels to the extraordinary investigations of Sherlock Holmes. Special passages from these works, gathered here in the form of long extracts, evoke the passion of the celebrated detective for cocaine and constitute rather generally an original sort of evidence on the emergence of drug addicts in Europe at the end of the 19th century.