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Organ donation after a circulatory determination of death is possible in selected patients where consent is given to support donation and the patient has been legally declared dead by two doctors. The National Health Act (61 of 2003) and regulations provide strict controls for the certification of death and the donation of organs and tissues after death. Although the National Health Act expressly recognises that brain death is death, it does not prescribe the medical standards of testing for the determination (...) of brain death (neurological determination of death), circulatory death (circulatory determination of death) or for determination of death based on somatic criteria. However, in all cases of organ donation, including after circulatory death, the National Health Act mandates that two doctors certify the death, with one doctor possessing more than 5 years of experience. Additionally, both doctors must be independent from the transplant team. The standard for such determination, as for brain death, aligns with accepted medical standards. The Critical Care Society of Southern Africa has published South African (SA) Guidelines on Death Determination that outline rigorous standards for death determination in hospital settings by either a neurological or circulatory method. Legislation and the Health Professions Council of SA’s (HPCSA) professional guidance direct clinicians on obtaining informed consent for donation either from the patient or in cases of incapacity from their surrogate decision maker. Collectively, the legislation, regulations and professional guidelines in SA provide a robust ethical framework that supports organ donation after circulatory death. (shrink)

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The existing ethico-legal regulation of adolescent children's participation in health research in South Africa is currently unclear. The article interrogates the existing framework governing children's consent to research participation, with specific emphasis on discrepancies in consent norms in law and ethical guidelines. Against the backdrop of the constitutional directive that requires that a child's best interests are of paramount importance in every matter concerning the child, the article assesses whether sufficient consideration is given to children's evolving maturity and capacities when (...) consent to their participation in health research is sought. The article provides specific recommendations and proposes a legislative change to consent provisions in the National Health Act 61 of 2003 in order to address the existing lacunae and to align the framework with constitutional imperatives and international fundamental rights considerations. (shrink)

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The purpose of this article is to address the questions as to whether a criminal conviction of a healthcare practitioner should affect his or her professional standing, and whether such conviction constitutes ‘unprofessional conduct’ in terms of the Health Professions Act. The article also explores a related matter, namely whether the Health Professions Council of South Africa (HPCSA) has a legal duty to refer complaints regarding unprofessional conduct that displays criminal elements for criminal prosecution. After considering relevant case law on (...) these issues, the article concludes that a practitioner, after being convicted of an offence, should be afforded an opportunity to explain him- or herself to the board, not only in extenuation of the conduct in question, but also in response to the question of whether the conduct constitutes improper or disgraceful conduct. Moreover, the article explains why the HPCSA and professional boards have a legal duty to refer matters of unprofessional conduct with criminal elements in terms of section 34 of the Prevention and Combating of Corrupt Activities Act to law enforcement agencies. (shrink)

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Chapter 19 of the Children’s Act No. 32 of 2005 regulates the practice of surrogate motherhood in South Africa and provides legal certainty regarding the rights of the children born as a result of surrogacy, including the rights of the different parties involved. Despite the clarity regarding the legal consequences of human reproduction by artificial fertilisation of women acting as surrogate mothers, some legal gaps and inconsistencies regarding certain medical and ethico-legal issues remain. The purpose of this article is to (...) critically examine selected provisions whose implementation is hampered by a lack of detail or clarity, compromising compliance by the different parties to the surrogate motherhood agreement. The article concludes with recommendations on how some of these issues may be addressed to provide for legal certainty and transparency. (shrink)

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Private medical aids are essentially non-profit organisations that aim to deliver speedy treatment and should prevent members from unexpected, out of pocket expenses for medical care. However, although the latest statistics show that 16.2% of individuals in South Africa were members of medical aid schemes, making the promise of private healthcare accessible to a small percentage of the population, they are not without their own unique set of challenges. The restrictions that exist within the private sector have a direct bearing (...) on the types of healthcare services patients can access, which in turn impacts on the fundamental right to access healthcare. Using a recent High Court Case decision, this article seeks to explore whether there is justice in the provision of healthcare services, specifically within the private sector in South Africa. (shrink)

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While open science gains prominence in South Africa with the encouragement of open data sharing for research purposes, there are stricter laws and regulations around privacy – and specifically the use, management and transfer of personal information – to consider. The Protection of Personal Information Act No. 4 of 2013 (POPIA), which came into effect in 2021, established stringent requirements for the processing of personal information and has changed the regulatory landscape for the transfer of personal information across South African (...) borders. At the same time, draft national policies on open science encourage wide accessibility to data and open data sharing in line with international best practice. As a result, the operation of research ethics committees (RECs) in South Africa is affected by the conflicting demands of the shift towards open science on the one hand, and the stricter laws protecting participants’ personal information and the transfer thereof, on the other. This article explores the continuing evolving role of RECs in the era of open data and recommends the development of a data transfer agreement (DTA) for the ethical management of personal health information, considering the challenges that RECs encounter, which centres predominantly on privacy, data sharing and access concerns following advances in genetic and genomic research and biobanking. (shrink)

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The doctor-patient relationship is the foundation of any medical intervention. Over time, the relationship has changed, from the era of paternalism to the era of self-determination or patient autonomy, following changes resulting from consumerism and lately, in South Africa, socialised medicine as a result of the proposed National Health Insurance. The premise of this article is that patient autonomy is invariably limited by a determination of who will carry the cost of a medical intervention. In recent years, legislative developments have (...) affected the understanding of a patient and doctor through the introduction of new references, such as ‘user’, ‘data subject’ and ‘consumer’ for a patient, and ‘service provider’ and ‘responsible party’ for a doctor, each giving different meanings to the doctor-patient relationship. Recent statutory additions also include new remedies available to aggrieved patients as parties in the doctor-patient relationship. The article concludes with brief observations on how the NHI will alter the essence and nature of the doctor-patient relationship in future. (shrink)

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Genomic and biobank research has undergone exponential growth in Africa. Traditionally this resulted in exploitative research practices in the form of so-called ‘parachute research’ with little or no consideration for capacity building. However there has been a recent growth of research and consortia where capacity building and equitable research have been a key objective of the research, and attention is now focused on the governance of this research. The importance of solidarity in genomic biobank research in high income countries is (...) well established and such an ethos reflects the communal based worldviews prevalent in many African communities. However, if the governance of the research is to foster equitable research practices, there must be some reciprocal benefit. This chapter will explore the impact that reciprocity will have on solidarity and how this may manifest in a governance framework in Africa. Particular focus will be given to capacity building and benefit sharing to enable the research to develop for the benefit of the local population, in a manner that promotes trust and fairness. This chapter will conclude with some recommendations on how to ensure reciprocity is enshrined in a governance framework for genomic biobank research in Africa. (shrink)

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