| Title: |
The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 3. Stool as a ‘drug’ or medicine |
| Authors: |
Labuschaigne, M; Slabbert, M; Budree, S; Hoosien, E; Brink, A; Blockman, M |
| Source: |
South African Medical Journal; Vol 110, No 8 (2020); 819-821 ; 2078-5135 ; 0256-9574 |
| Publisher Information: |
South African Medical Association |
| Publication Year: |
2020 |
| Collection: |
South African Medical Journal (SAMJ) |
| Subject Terms: |
Ethicolegal framework; Faecal microbiota transplantation |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
http://samj.org.za/index.php/samj/article/view/13042/9417; http://samj.org.za/index.php/samj/article/view/13042 |
| DOI: |
10.7196/SAMJ.2020.v110i8.15070 |
| Availability: |
http://samj.org.za/index.php/samj/article/view/13042; https://doi.org/10.7196/SAMJ.2020.v110i8.15070 |
| Rights: |
Copyright of published material remains in the Authors’ name. This allows authors to use their work for their own non-commercial purposes without seeking permission from the Publisher, subject to properly acknowledging the Journal as the original place of publication. Authors are free to copy, print and distribute their articles, in full or in part, for teaching activities, and to deposit or include their work in their own personal or institutional database or on-line website. Authors are requested to inform the Journal/Publishers of their desire/intention to include their work in a thesis or dissertation or to republish their work in any derivative form (but not for commercial use).  Material submitted for publication in the SAMJ is accepted provided it has not been published or submitted for publication elsewhere. Please inform the editorial team if the main findings of your paper have been presented at a conference and published in abstract form, to avoid copyright infringement. |
| Accession Number: |
edsbas.12F7A51D |
| Database: |
BASE |