Abstract
During faecal microbiota transplantation, stool from a healthy donor is transplanted to treat a variety of dysbiosis-associated gut diseases. Competent authorities are faced with the challenge to provide adequate regulation. Currently, regulatory harmonization is completely lacking and authorities apply non-existing to most stringent requirements. A regulatory approach for faecal microbiota transplantation could be inserting faecal microbiota transplantation in the gene-, cell- and tissue regulations, including the hospital exemption system in the European Advanced Therapy Medicinal Products regulation, providing a pragmatic and efficacy-risk balanced approach and granting all patients as a matter of principle access to this therapy.
Highlights
During faecal microbiota transplantation, stool from a healthy donor is transplanted to treat a variety of dysbiosisassociated gut diseases
Antibiotic-associated nosocomial diarrhoea and colitis are frequently caused by a Clostridium difficile infection, a result of gut microbiota dysbiosis [8,9,10]
Regarding Oceania, a publication from 2016 estimated the occurrence of C. difficile infection in Australia to account for approximately 12,700 cases between 2011 and 2012 [27] with a hospitalisation cost of approximately AU$ 19,000 per patient based on Bond et al (2017) [28]
Summary
The regulation of faecal microbiota transplantation must be comparable around the world. Safe and regulated access to faecal microbiota transplantation currently still majorly depends on the country where the patients are living in
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