Stem cell tourism in South Africa: The legal position

Stem cell tourism has become a common phenomenon worldwide and is increasingly affecting South Africa, as is evident from recent media reports. We examine the South African legal framework regulating stem cell therapy, focusing first on the effects of unproven stem cell treatments, and provide recommendations that may assist in strengthening the legal position

The legal position on the classification of human tissue in South Africa: Can tissues be owned?

The ownership of tissue samples donated for medical research is an ongoing subject of dispute. Some advocates assert that patients have ongoing ownership rights in their tissues, including an unfettered right to determine what happens to their tissue sample. Researchers argue that giving patients property rights in their samples will turn the human body and body parts into a commodity and bring research to a halt. The question of the human body as property involves complex and philosophical dimensions. The law displays an uneasiness in making sense of the human body in the context of ownership and property, as the notion of owning oneself (and one’s tissues) implies that persons are able to objectify their selves, and in the process become susceptible to objectification by others. The creation of commercial products from human tissue has generated very difficult legal and ethical questions that have no clear, universally accepted answers

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

The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 1. A legal vacuum

The legal regulation of faecal microbiota transplantation (FMT) in South Africa (SA) is currently unclear. The purpose of this article, the first of three in a series, is to explore the nature, role and clinical application of FMT in SA in order to determine, from a legal perspective, the appropriate regulatory pathways governing FMT as a procedure that may combine approaches for the treatment of drugs, human tissue for transplantation, or clinical treatment as part of the practice of medicine. FMT has been shown to be a novel, safe and effective treatment for recurrent Clostridioides difficile infection (CDI). Stool banks are instrumental in enabling access to FMT for patients and clinicians and help to catalyse research in the microbiome. However, the regulatory landscape in SA remains unclear. Microbial therapies such as FMT are necessary, especially in a time of rising microbiome-associated inflammatory diseases and increasing resistance to traditional antibiotics. FMT is now considered as part of the standard of care for recurrent CDI overseas, but is currently only being used for research purposes in a minority of clinical cases of CDI in SA. This article, which lays the foundation for consideration of this question in three parts, suggests that the relevant regulatory system would depend on the categorisation of human stool as tissue, the exact composition of the FMT, how it is administered to patients, and the relevant levels of manipulation of the stool for FMT-derived products

The Consumer Protection Act: No-fault liability of health care providers

The introduction of no-fault or strict liability by the Consumer Protection Act 68 of 2008 (CPA) poses serious problems in the health care context. With a patient as a ‘consumer’ in terms of the CPA, health care practitioners may find themselves as ‘suppliers’ or ‘retailers’ as part of a supply chain, and potentially liable for harm and loss suffered by a patient in terms of the new no-fault liability provision. The claimant (patient) can sue anyone in the supply chain in terms of this provision, which places the health care practitioner who delivered the care in a very difficult position, as he or she is the most easily and often only identifiable person in the supply chain. Although the causal link between the harm suffered by the complainant will still need to be established on a balance of probabilities, the traditional common law obstacle requiring proof of negligence no longer applies. The article argues that this situation is unsatisfactory, as it places an increasingly onerous burden on certain health care practitioners

Early prediction of adult police dog efficiencydA longitudinal study

Abstract The problem at the South African Police Service Dog Breeding Centre was that most of their progenies were unsuitable as police dogs. Behaviour tests were developed specifically for police dogs to predict their efficiency as adults. Puppies from the age of 8 weeks were exposed to situations that they probably would encounter in their work as police dogs. These experiences included crossing of obstacles, retrieval of objects, startle stimuli and aggression. In the longitudinal study of 2 years it was found that all the tests had statistical significance to a greater or lesser extent, except the gunshot test. The most significant tests were retrieval at 8 weeks and aggression at 9 months. These tests thus enable selection for suitable dogs as early as 8 weeks of age, but not later than 9 months. The conclusion is that reliable tests can predict adult police dog efficiency and in doing so, save unnecessary training and other costs on unsuccessful dogs.

The legal position on the classification of human tissue in South Africa : can tissues be owned?

The ownership of tissue samples donated for medical research is an ongoing subject of dispute. Some advocates assert that patients have ongoing ownership rights in their tissues, including an unfettered right to determine what happens to their tissue sample. Researchers argue that giving patients property rights in their samples will turn the human body and body parts into a commodity and bring research to a halt. The question of the human body as property involves complex and philosophical dimensions. The law displays an uneasiness in making sense of the human body in the context of ownership and property, as the notion of owning oneself (and one’s tissues) implies that persons are able to objectify their selves, and in the process become susceptible to objectification by others. The creation of commercial products from human tissue has generated very difficult legal and ethical questions that have no clear, universally accepted answers.http://www.sajbl.org.za/index.php/sajblam201