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The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 3. Stool as a ‘drug’ or medicine

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

Abstract


The purpose of this article, the last in a series of three exploring the legal framework for the regulation of faecal microbiota transplantation (FMT) in South Africa (SA), is to determine the regulatory framework that applies to microbial-based treatments involving a level of manipulation that exceeds that of basic stool transplantation, e.g. processed FMT-derived products in capsule form. The article highlights the legal requirements for the registration of these products as biological medicines in SA law. Although human stool banks are not regulated in terms of the National Health Act 61 of 2003 (NHA) and regulations, the earlier articles point out that human stool fits the definition of human tissue and human biological material as defined by the NHA. For this reason, stool banks should be considered tissue banks in terms of the NHA and regulations. Healthcare practitioners and researchers involved in FMT banking and transplantation should strive to comply with these regulations in the absence of clear legal direction at present.


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; 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):819-821. DOI:10.7196/SAMJ.2020.v110i8.15070

Article History

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

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