Department of Jurisprudence, School of Law, University of South Africa.
S Afr Med J. 2020 Jul 29;110(8):816-818. doi: 10.7196/SAMJ.2020.v110i8.15069.
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.
粪便微生物群移植（FMT）已被证明是治疗复发性艰难梭菌感染的有效方法。本文是三篇系列文章中的第二篇，旨在探讨南非（SA）人类 FMT 的法律框架。FMT 涉及不同的管理模式，需要不同的监管考虑。本文的重点是根据 2003 年第 61 号《国家卫生法》，探索人类粪便作为组织的法律分类，以及人类粪便库作为组织库的监管。本文最后提出了具体建议，旨在改善南非 FMT 监管方面目前的监管空白。
