Faecal microbiota transplantation: A life-saving therapy challenged by commercial claims for exclusivity.

ABSTRACT: Faecal microbiota transplantation (FMT) is an innovative treatment which is challenged by a regulatory struggle in Europe. A recent publication in EClinicalMedicine describes the successful adaptation of FMT to a National drug legislation, but this approach fails to take into account the donor-related aspects. The European tissue and cells directive and affiliated technical guide provide extensive safety and quality standards which may readily be adopted in an FMT service to provide patients with this life-saving treatment embedded in a public blood centre.

SUBMITTER: Hvas CL 

PROVIDER: S-EPMC7334803 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature