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

Christian Lodberg Hvas; Simon Mark Dahl Baunwall; Christian Erikstrup

doi:10.1016/j.eclinm.2020.100436

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

EClinicalMedicine. 2020 Jul 2:24:100436. doi: 10.1016/j.eclinm.2020.100436. eCollection 2020 Jul.

Authors

Christian Lodberg Hvas¹, Simon Mark Dahl Baunwall¹, Christian Erikstrup²

Affiliations

¹ Department of Hepatology and Gastroenterology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus, DK 8200, Denmark.
² Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.

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.

Keywords: Clostridioides difficile; Faecal microbiota transplantation; Regulation.