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

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-relat...

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Bibliographic Details
Published in:EClinicalMedicine 2020-07, Vol.24, p.100436-100436, Article 100436
Main Authors: Hvas, Christian Lodberg, Baunwall, Simon Mark Dahl, Erikstrup, Christian
Format: Article
Language:English
Subjects:
Clostridioides difficile
Faecal microbiota transplantation
Regulation
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Summary: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.
ISSN:2589-5370
2589-5370
DOI:10.1016/j.eclinm.2020.100436