The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 2. Human stool as tissue?
Faecal microbiota transplantation (FMT) has been shown to be an effective treatment for recurrent Clostridioides difficile infection. The purpose of this article, the second of a series of three articles, is to explore the legal framework governing human FMT in South Africa (SA). FMT involves different modes of administration that require different regulatory considerations. The focus of this article is to explore the legal classification of human stool as tissue in terms of the National Health Act 61 of 2003, as well as the regulation of human stool banks as tissue banks. The article concludes with specific recommendations aimed at improving the current regulatory vacuum relating to the regulation of FMT in SA.
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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Date published: 2020-07-29
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