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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. [ABSTRACT FROM AUTHOR]

Private medical aids are essentially non-profit organisations that aim to fund the delivery of speedy treatment, and should protect members from unexpected, out-of-pocket expenses for medical care. However, although the latest statistics show that 16.2% of individuals in South Africa (SA) are 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 decision, this article seeks to explore justice in the provision of healthcare services, specifically within the private sector in SA. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 (NHI). 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. [ABSTRACT FROM AUTHOR]

Globally, there has been a move toward 'open science' that includes the sharing of health data for research. The importance of data sharing for research is generally acknowledged, but this must only be done with legal and ethical procedures and protections in place. The use and sharing of health data for research in South Africa has changed with the coming into force of the Protection of Personal Information Act (POPIA). POPIA should ensure greater transparency and accountability in the use of personal information. POPIA, however, adopts a principle-based approach to the regulation of personal information, and there is a lack of clarity and uncertainty in the application of some of these principles to the use of health data for research. POPIA provides for sector-specific responses through the development of codes of conduct. In this article, we discuss the need for a code of conduct for health research, and an approach that could be adopted in its development. [ABSTRACT FROM AUTHOR]

Realisation of the value and the commercialisation potential of data is gaining exponential momentum. The combination of historical data exploitations and the use of technologies that allow for the triangulation of data results in the collection, storage, and processing of massive amounts of data require diligent data management, including adherence to privacy and other laws, both nationally and internationally. The intrinsic value of scientific data, especially in genomics, becomes apparent when data are shared, often in collaboration with international partners, and compiled into big data sets that are subsequently used for benefit, including commercial benefit. The purpose of this article is to explore the commercialisation of data in South Africa against the backdrop of the legal framework governing the protection of personal information, confidentiality and privacy, with a specific focus on genetic and genomic information. Related issues, such as the collection and sharing of data, ownership of data and challenges about informed consent are also considered. After a brief evaluation of the African regulatory landscape relating to the protection of personal information, the article concludes with a few recommendations aimed at improving the status quo and sensitising the South African public as to the value of their data and personal information, as well as the potential uses and abuses to which their personal information may be subjected. [ABSTRACT FROM AUTHOR]

Africa, and sub-Saharan Africa in particular, is one of the last continents to have recorded COVID-19 cases, and is expected to be severely impacted by the virus. The lack of intensive care capacity and under-resourced public healthcare settings in many African countries, coupled with high levels of poverty and poor access to healthcare services, applies to some extent to South Africa (SA). The SA government's swift and decisive response to address COVID-19 in March 2020, although praised by many, is increasingly being criticised for its disproportionate, contradictory and harsh consequences, not to mention a range of legal challenges that have followed since the introduction of lockdown measures in terms of the Disaster Management Act. This article examines some of the ethical and legal issues relating to the government's approach to COVID-19. [ABSTRACT FROM AUTHOR]

The role of health research ethics committees (RECs) has evolved dramatically over the past few decades. Novel and specialised research, multicentre trials across borders and commercially sponsored research, coupled with a huge increase in the number and complexity of research protocols, and capacity and resource constraints on the part of RECs, have led to serious breaches regarding the protection of human participants. Research involving the exchange or cross-border transfer of human biological materials (HBMs) requires specialised legal and ethical knowledge relating to multiple governance frameworks. RECs may be required to monitor compliance not only with contractual requirements, but also the national laws and national ethical guidelines and standards of selected jurisdictions, not to mention adherence to international regulatory instruments governing biomedical research generally, and the conditions for the collection and use of HBMs specifically. The South African (SA) legislator's decision to make RECs signatories to the prescribed material transfer agreement (MTA) template is a first step in the right direction, reinforcing the role and responsibilities of RECs, and their duty of care towards human participants in research. In addition, there has to be a transformation of the general mindset, towards accepting ethical principles within legal documents, particularly legal documents that involve the REC and create binding provisions that have a direct impact on participants. It is time that African views and participant protections are respected and accepted with the same vigour commanded by the Western world. In this article, the role of RECs in general is considered, prior to focusing on their responsibilities with respect to HBM transfer. The ethicoregulatory framework for REC functioning is discussed both from global and national perspectives. Also deliberated is the critical role that RECs play in reviewing health research proposals when HBMs are transferred between institutions, and the REC as a party to the SA national MTA template. [ABSTRACT FROM AUTHOR]

The demand for human tissue in the medical context has increased rapidly since the early 1980s, when the use of human bone in allografts in orthopaedic surgery became the norm. During the 1990s, the demand for human tissue turned towards tissue-engineered products in the field of regenerative medicine. Tissue engineering, as an established and growing interdisciplinary field comprising different specialties, such as medicine, materials science, cell biology, genomics and chemical engineering, aims to develop biological substitutes to restore, maintain or improve tissue function, thus offering patients the chance to regain normal functionality in their bodies. The purpose of this article is to explore some of the gaps that exist in the current regulatory framework that governs tissue banks in South Africa (SA), and to make certain recommendations aimed at closing these gaps. The discrepancies and gaps cause confusion and may lead to undesired and unforeseen consequences regarding the use of human tissue, as well as prejudice the welfare of patients in SA. [ABSTRACT FROM AUTHOR]