Faecal microbiota transplantation: A life-saving therapy challenged by commercial claims for exclusivity.
Where this comes from
- Record sourced from PubMed, PMID 32642633.
- Also identified by DOI 10.1016/j.eclinm.2020.100436 and PMC identifier 7334803.
- Licence recorded as CC BY-NC-ND.
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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.