Ethicolegal framework for the regulation of human faecal microbiota transplants in South Africa: Progress, challenges and recommendations

This article examines the ethicolegal challenges in regulating faecal microbiota transplantation (FMT) in South Africa (SA), where a regulatory vacuum under the National Health Act 61 of 2003 (NHA) and Medicines and Related Substances Act 101 of 1965 (MRSA) hinders the implementation of FMT. FMT effectively treats recurrent Clostridioides difficile infection by restoring gut microbiome balance, with potential for broader applications, but lacks clear classification as human tissue, biological material, or a medicine under the existing framework. The article suggests regulatory classifications for the different types of human stool under both the NHA and the MRSA. Drawing on relevant guidelines issued by the Food and Drug Administration in the USA and the European Medicines Agency, including the 2024 European Union’s Substances of Human Origin (SoHO) Regulation, which standardises microbiota safety and traceability, the article concludes with recommendations aimed at closing the existing regulatory vacuum concerning FMT in SA.