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The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 1. A legal vacuum

M Labuschaigne, M Slabbert, S Budree, E Hoosien, A Brink, M Blockman

Abstract


The legal regulation of faecal microbiota transplantation (FMT) in South Africa (SA) is currently unclear. The purpose of this article, the first of three in a series, is to explore the nature, role and clinical application of FMT in SA in order to determine, from a legal perspective, the appropriate regulatory pathways governing FMT as a procedure that may combine approaches for the treatment of drugs, human tissue for transplantation, or clinical treatment as part of the practice of medicine. FMT has been shown to be a novel, safe and effective treatment for recurrent Clostridioides difficile infection (CDI). Stool banks are instrumental in enabling access to FMT for patients and clinicians and help to catalyse research in the microbiome. However, the regulatory landscape in SA remains unclear. Microbial therapies such as FMT are necessary, especially in a time of rising microbiome-associated inflammatory diseases and increasing resistance to traditional antibiotics. FMT is now considered as part of the standard of care for recurrent CDI overseas, but is currently only being used for research purposes in a minority of clinical cases of CDI in SA. This article, which lays the foundation for consideration of this question in three parts, suggests that the relevant regulatory system would depend on the categorisation of human stool as tissue, the exact composition of the FMT, how it is administered to patients, and the relevant levels of manipulation of the stool for FMT-derived products.


Authors' affiliations

M Labuschaigne, Department of Jurisprudence, School of Law, University of South Africa

M Slabbert, Department of Jurisprudence, School of Law, University of South Africa

S Budree, Department of Paediatrics, Faculty of Health Sciences, University of Cape Town, South Africa; OpenBiome, Cambridge, Mass., USA

E Hoosien, Clinical Microbiology Department, Ampath Laboratories, Centurion, South Africa

A Brink, Division of Medical Microbiology, Department of Pathology, Faculty of Health Sciences, University of Cape Town, South Africa; and National Health Laboratory Service, Cape Town, South Africa

M Blockman, Division of Clinical Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, South Africa

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Keywords

Ethicolegal framework; Faecal microbiota transplantation

Cite this article

South African Medical Journal 2020;110(8):812-815. DOI:10.7196/SAMJ.2020.v110i8.14563

Article History

Date submitted: 2020-07-29
Date published: 2020-07-29

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