This article examines the ethicolegal challenges in regulating faecal microbiota transplantation (FMT) in South Africa (SA), where a regulatory vacuum under the National Health Act 61 of 2003 (NHA) and Medicines and Related Substances Act 101 of 1965 (MRSA) hinders the implementation of FMT. FMT effectively treats recurrent Clostridioides difficile infection by restoring gut microbiome balance, with potential for broader applications, but lacks clear classification as human tissue, biological material, or a medicine under the existing framework. The article suggests regulatory classifications for the different types of human stool under both the NHA and the MRSA. Drawing on relevant guidelines issued by the Food and Drug Administration in the USA and the European Medicines Agency, including the 2024 European Union’s Substances of Human Origin (SoHO) Regulation, which standardises microbiota safety and traceability, the article concludes with recommendations aimed at closing the existing regulatory vacuum concerning FMT in SA.
This article examines what Chile’s neurorights reforms may mean for South Africa (SA)’s legal and ethical framework. Chile is the first country to adopt an explicit constitutional and legislative response to neurotechnology, including protection for brain activity and information derived from it. Using Chile as a comparative lens, the article argues that SA does not necessarily require an immediate sui generis constitutional amendment to address neurorights-type concerns. Rather, existing constitutional protections for dignity, privacy, bodily and psychological integrity, freedom of thought and informed consent are already normatively receptive to many of the harms posed by emerging neurotechnologies. The more urgent challenge lies in timing; SA law remains largely reactive, often offering remedies only after intrusion, extraction or misuse has already occurred. The article therefore contends that protection should move upstream through proactive, risk-sensitive procedural reform and anticipatory governance, particularly in high-risk contexts involving coercion, asymmetrical power or intimate mental inference. It further argues that a neurotechnology-sensitive interpretation of existing rights, informed by local constitutional doctrine, neuroethics, and SA concerns around dignity, vulnerability and relational personhood, provides a more coherent and contextually appropriate path than immediate constitutional transplantation. The article concludes by outlining the general contours of ex ante safeguards for neurotechnology in SA while leaving open the possibility that more explicit neurorights protections may become necessary if existing doctrines prove systematically under-protective.
Background. South Africa (SA)’s pluralistic mental health system reflects a coexistence of biomedical and traditional healing paradigms. While this plurality enhances cultural accessibility and patient trust, it also raises ethical and legal uncertainty regarding professional accountability and liability. The absence of harmonised governance between the Health Professions Council of South Africa and the Traditional Health Practitioners Council complicates interprofessional collaboration and increases the risk of professional exposure. Objectives. To explore how psychologists, psychiatrists and traditional health practitioners (THPs) understand risk, liability and accountability in pluralistic mental healthcare, and to identify areas where ethical and legal frameworks could be strengthened to support culturally responsive and legally coherent collaboration. Methods. A qualitative exploratory-descriptive design was employed. Semi-structured interviews were conducted with 19 practitioners, comprising psychologists, psychiatrists and THPs. Data were analysed using Braun and Clarke’s thematic framework to identify shared and divergent understandings of professional responsibility, ethical practice and legal accountability. Results. Three overarching themes emerged: ambiguity in professional accountability, ethical tensions arising from cultural responsibility, and the need for policy and legal reform. Practitioners recognised the value of pluralistic care, but cited an absence of clear ethical guidance, referral systems and shared documentation protocols. Psychologists and psychiatrists expressed concern about malpractice liability, while THPs highlighted marginalisation within formal regulation. Participants emphasised the importance of ethical frameworks that respect cultural pluralism while protecting professional integrity and patient safety. Conclusion. Pluralistic collaboration is an established feature of mental healthcare in SA, but remains ethically and legally underdefined. Aligning the Health Professions Act 56 of 1974 and the Traditional Health Practitioners Act 22 of 2007 through joint policy development would clarify accountability and reduce liability risk. Interprofessional ethics education and formal referral mechanisms are essential to integrate cultural legitimacy with legal coherence.
A significant number of students handle personal information (PI) during work-integrated learning and supervised research, requiring compliance with both South African (SA) law and internationally derived research ethics instruments. Where these instruments use different terminology, students face barriers to understanding, reflecting not only linguistic differences but materially distinct legal standards and regulatory consequences. Using the Framework Method across seven analytical dimensions, this study examined the conceptual equivalence of key PI protection terms across four sources: the Oxford English Dictionary, the European Union General Data Protection Regulation (GDPR), the Council for the International Organizations of Medical Sciences (CIOMS) ethical guidelines for human research, and SA’s Protection of Personal Information Act 4 of 2013 (POPIA). Three findings emerged. First, GDPR’s ‘anonymisation’ and POPIA’s ‘de-identification’, although similar in stated purpose, apply different threshold tests: GDPR uses a probability test (whether re-identification is reasonably likely), while POPIA applies a capacity test (whether re-identification is possible by any reasonably foreseeable method). A data set compliant under GDPR may therefore not satisfy POPIA. Second, the instruments diverge on regulatory scope: GDPR treats anonymisation as an exit from regulation, whereas POPIA imposes ongoing obligations on de-identified data, including an explicit re-identification prohibition absent from GDPR. Third, CIOMS and POPIA are more conceptually compatible with each other than either is with GDPR, yet CIOMS employs GDPR-tradition terminology, creating misleading signals of equivalence for SA students. These divergences reflect fundamentally different conceptions of PI and the rationale for its protection. Students, educators and institutional governance structures must address these distinctions explicitly, rather than assuming terminological equivalence across instruments.
Background. Over the past decade, South Africa (SA)’s healthcare landscape has shifted significantly as a result of policy reforms, including the Consumer Protection Act and amendments to the National Health Act. These changes have reframed the doctor-patient relationship, introducing economic and systemic pressures that may influence ethical decision-making. Objectives. To revisit the patterns of professional misconduct of SA medical practitioners from 2014 to 2023, comparing findings with those of a previously published study (covering 2007 - 2013) to identify emerging trends and to reflect on the efficacy of past recommendations. Methods. A mixed-methods approach was used to analyse published disciplinary records from the Health Professions Council of South Africa, excluding 2019 owing to data unavailability. Quantitative data were analysed using statistical tests to assess differences in transgression frequencies and sanction patterns between time periods. Qualitative analysis was used to categorise transgressions into several general and specific types to assess shifts in the patterns of professional misconduct. Results. The average percentage of practitioners found guilty of misconduct decreased significantly from 0.164% (2007 - 2013) to 0.087% (2014 - 2023) of registered practitioners. However, the average number of guilty verdicts per practitioner remained statistically unchanged, indicating a persistent pattern of repeat offences. Notable shifts in transgression types included a decrease in fraudulent conduct and an increase in documentation-related negligence. Conclusion. Although fewer practitioners were found guilty over the period of the present study, professional misconduct transgressions remained concentrated among repeat offenders. The study underscores the value of reinforcing the social contract in healthcare by recommending individualised ethics coaching for transgressors and revising current sanctioning practices to more effectively deter repeat misconduct.
Filicide, the intentional killing of a child by a parent or parental figure, presents profound challenges within South Africa (SA)’s justice system. Despite its exceptional nature, filicide is prosecuted under the common-law crime of murder. Although filicide falls within the ambit of common-law murder, the absence of a distinct legal category obscures the unique psychological, relational and socioeconomic factors that differentiate these cases from other homicides. Sentencing practices reveal deep inconsistency, shaped by judicial discretion, the minimum-sentencing regime, and gendered narratives. This article argues that SA should retain filicide within common-law murder but urgently adopt national sentencing guidelines, mandatory pre-sentencing mental health assessments, and integrated prevention pathways linking social services, health systems and law enforcement. Establishing a national filicide database would further strengthen monitoring and policy design. By situating filicide within its broader sociolegal context, this article underscores the need for a co-ordinated, multidisciplinary response capable of preventing tragedy, ensuring consistent, proportionate sentencing, and protecting the country’s most vulnerable group.
Background. The COVID‐19 pandemic accelerated global telehealth adoption, yet South Africa (SA) continues to face barriers owing to outdated regulations, fragmented infrastructure, and limited integration of artificial intelligence (AI). While national frameworks acknowledge the role of AI, a dedicated strategy for its implementation in healthcare is absent. This study draws on international governance frameworks and comparative policy analysis to explore pathways for inclusive and effective AI‐enabled telehealth in SA. Objectives. To assess current telehealth and AI policy landscapes in SA, identify implementation gaps, and provide actionable recommendations for aligning national strategies with international standards and healthcare needs. Methods. A qualitative policy analysis was conducted, reviewing SA regulatory instruments, including Health Professions Council of South Africa guidelines, the National AI Policy Framework and the National Health Insurance Act 20 of 2023, alongside the World Economic Forum (WEF)’s 2025 White Paper on AI in healthcare. A thematic comparative approach identified regulatory and infrastructural gaps, and proposed frameworks for sector‐specific policy advancement. No human participants were included. Results. SA’s revised Telehealth Guidelines (2021) remain restrictive and lack provisions for AI integration. The National AI Policy Framework outlines ethical AI governance but fails to detail healthcare‐specific implementation. In contrast, the WEF framework offers a phased, stakeholder‐driven model for AI adoption, emphasising data governance, digital infrastructure, and workforce training – critical elements currently missing in SA’s approach. Conclusion. A national AI‐in‐healthcare roadmap, supported by regulatory reform, a dedicated oversight body, and investment in digital infrastructure, is essential for equitable telehealth expansion. Further research should focus on scalable models for rural and underserved populations.
Victims of sexual offences who have intellectual disabilities (IDs) face many challenges when formal charges are laid. When seeking a just outcome, the legal fraternity relies on valid and reliable testimony in order to prosecute alleged perpetrators. This review article discusses some of these challenges, which could include other comorbid medical and psychiatric conditions, firstly defining ID together with a classification of severity. The authors then provide some insights into the victim assessment unit at Sterkfontein Hospital with regard to the history of the outpatient unit, procedure, methods of assessment, and reporting to the courts. Finally, some important ethicolegal considerations are considered, emphasising the facilitation of legal processes and ensuring justice while preserving autonomy, beneficence and non-maleficence. The review concludes with a recommendation for an analysis of all victims who have been referred to the unit to date.
In the case of Semenya v Switzerland, the European Court of Human Rights held that when athletes complain to their sport’s governing bodies regarding regulations that undermine their human rights, which such bodies claim are compatible with substantive public policy, the arbitration or reviewing bodies must rigorously – and not restrictively – examine the breaches of the athletes’ fundamental rights before deciding a case. This decision should result in important changes to the governance of international sport.
Preterm birth, defined by the World Health Organization as any birth occurring before 37 weeks of gestation, remains a significant global health challenge, contributing to high rates of neonatal mortality and long-term complications. In this context, artificial womb technology-or ectogenesis-offers a transformative intervention capable of sustaining extra-uterine gestation and improving outcomes for extremely preterm infants.This article explores the legal, ethical and societal implications of introducing artificial wombs in South Africa, where existing laws regulating pregnancy, birth and personhood are ill-equipped to address this technological shift. In particular, the definitional limits of the Choice on Termination of Pregnancy Act, the conditional nature of the nasciturus fiction, and the ambiguity surrounding parental authority and legal guardianship over gestatelings, is analysed. I argue for the development of a bespoke legal framework to regulate ectogenesis, rather than amending existing pregnancy or birth legislation, and propose a set of principles to guide future regulation. Additionally, I highlight how access to artificial wombs may reinforce healthcare inequality if limited to private medical settings. By proactively addressing the legal and policy challenges posed by ectogenesis, South Africa can advance a rights-based approach to reproductive healthcare while preparing for the ethical and legal complexities of this emerging technology. This article utilised a qualitative, doctrinal research methodology based on desktop analysis.The research involved the critical examination of primary legal sources such as constitutional provisions, statutes and relevant South African case law. Secondary sources included scholarly articles in medical law, bioethics and reproductive justice, particularly those addressing emerging technologies, e.g. ectogenesis. Comparative perspectives from jurisdictions such as the United Kingdom, the Netherlands, and the United States were also consulted to contextualise the legal challenges within broader international debates. Sources were selected using targeted searches of legal databases and peer-reviewed journals, with priority given to academic work that engages directly with the ethical, legal and regulatory dimensions of artificial womb technology.
Background. Transparency is a fundamental value in South Africa's constitutional and ethical framework, particularly in the appointment of statutory bodies such as the National Health Research Ethics Council (NHREC). The integrity of such appointments is crucial for maintaining public trust and ensuring that decisions are legally and ethically sound. An additional fundamental value is that those appointed be suitably qualified to perform their designated tasks. A transparent process alone is insufficient-the purpose of the process itself must also be respected. Transparency is directly linked to this second objective. The appointment of the NHREC has contravened the transparency of the process by not publishing the process and it has also circumvented the purpose of the process by appointing persons who have not been subjected to scrutiny. Objectives. This article demonstrates that the NHREC was constituted in an irregular manner, with key procedural requirements, designed to promote transparency and the appropriateness of the appointees, being overlooked. The article also explores the possible impact of this irregular appointment on the authority and validity of the NHREC's decisions. Methods. The article conducts a detailed analysis of the statutory requirements governing the appointment of the NHREC, followed by an examination of the irregularities in the appointment process. The prejudice to stakeholders and the broader implications for governance are also considered. Results. The investigation found that the NHREC's appointment process did not follow statutory requirements, leading to a significant irregularity. This undermines the legitimacy of both the council and its decisions, as it denies stakeholders the right to participate in the nomination process, violating principles of participatory democracy. Additionally, the credentials and suitability of appointees were not properly evaluated. As a result, the third edition of the Ethics Guidelines (2024) is legally vulnerable and could face challenges. Conclusion. Given these serious concerns about legitimacy, we recommend that the Minister of Health withdraws the third edition of the Ethics Guidelines and recommences the revision process once a properly constituted NHREC has been appointed. This approach restores the legitimacy of the NHREC and reaffirms the government's commitment to transparency, accountability and participatory democracy in the governance of health research ethics in South Africa.
South Africa has an unacceptably high rate of teenage pregnancies. Of particular concern is the number of pregnancies in 10 - 14-yearolds. In this age group, there has been a 48.7% increase in deliveries, with 2 726 taking place pre-Covid-19 (2017 - 2018) and 4 053 in 2020 - 2021. In response to these figures, there has been a range of calls for criminal law to play a greater role in deterring teenagers from engaging in underage sex which results in pregnancy. This article helps to explore the complexities and implications of a criminal law approach by firstly providing an overview of the existing legal framework regulating adolescent sexual and reproductive health rights; secondly, examining sexual offences that limit adolescent rights and their practical implications; and thirdly, discussing public health and rights consequences that may flow from using criminal law as part of a comprehensive strategy to address teenage pregnancy. It concludes that although both civil law and criminal law have a common goal - the promotion of sexual reproductive health rights of children and the protection against unhealthy and exploitative engagements - there is a disjuncture between their approaches, practically and ideologically. Civil law and its structures endeavour to create an educative, empowering and safe space where adolescents can get the support and services they need. Criminal law creates a hostile and disenfranchising space which research has shown creates a barrier to accessing sexual and reproductive health and rights (SRHR) owing to fear of reprimand, stigmatisation, re-victimisation, community ostracism, and familial or partner rejection. A concern is the divergent and perhaps even counter-intuitive ways in which these two mechanisms seek to achieve the common goal.
Healthcare regulation is often misunderstood as burdensome, yet it serves a critical function in safeguarding public health and maintaining professional integrity. The first objective of the present article is to explore the essential role of healthcare regulators in South Africa, with a focus on the Health Professions Council of South Africa (HPCSA). Established under the Health Professions Act 56 of 1974, the HPCSA oversees a broad mandate encompassing the registration, licensing and regulation of healthcare practitioners to ensure ethical and competent service delivery. The Council also establishes practice standards, evaluates educational programmes, promotes continuous professional development, and investigates complaints to ensure upholding public trust and safety. The second objective of the article is to clarify common misconceptions about healthcare regulation, including concerns about fee structures and registration suspension policies. It also aims to highlight the benefits that regulation offers healthcare professionals, such as enhanced credibility, legal compliance, and improved employment opportunities. The HPCSA's dual mandate to protect the public and guide professions is examined through its legislative framework and relevant case law such as HPCSA v Grieve. As healthcare evolves, regulators such as the HPCSA must adapt to emerging challenges, ensuring the sector remains safe, ethical and effective. The third objective is to underscore the indispensable value of regulation in preserving both public safety and the integrity of the healthcare profession.
Backgound. Surrogacy is a contentious reproductive technology that has garnered significant global attention, particularly following Pope Francis' 2024 condemnation of it and his advocacy for a universal ban, amid its rising prevalence in high-income regions driven by factors such as advancing parental age and the reproductive aspirations of single men, same-sex couples, and transgender individuals. This article evaluates surrogacy through the framework of the Universal Declaration of Bioethics and Human Rights (UDBHR), a 2005 UNESCO-adopted document establishing 15 universal bioethical principles to guide discussions on medicine, life sciences, and associated technologies, emphasising its role in fostering global ethical discourse grounded in human rights. Objective. The primary objective is to assess the ethical dimensions of surrogacy by applying the principles of the UDBHR, determining whether the declaration adopts a neutral stance, merely offers procedural guidelines, or provides a substantive ethical judgment on the practice. This provisional analysis posits a central theoretical argument that the UDBHR creates an ethical paradox by simultaneously legitimising surrogacy through procedural mechanisms while posing significant moral challenges to its acceptability, with the study confined to evaluative purposes without extending to policy recommendations. Method. The methodology employed is evaluative, critically examining surrogacy against the UDBHR's standards to gauge its ethical soundness, incorporating an interpretive analysis of how the declaration's principles intersect with surrogacy's ethical, legal and social facets. The approach begins with an explication of surrogacy's types, processes, reasons, costs and controversies, followed by a principleby-principle discussion under the UDBHR, drawing on limited existing literature such as the 2019 International Bioethics Committee (IBC ) Report, while maintaining a focus solely on ethical assessment. Results. The evaluation identifies a dual nature within the UDBHR: certain articles offer procedural support that implicitly endorses surrogacy when conducted ethically, aligning it with benefits like parenthood fulfillment and social responsibility. Conversely, other articles highlight substantive concerns, including maternal health risks, embryo commodification, child rights violations, exploitation of vulnerable women, and long-term impacts on offspring, thereby questioning surrogacy's moral foundation. Conclusion. The UDBHR manifests an inherent ethical paradox regarding surrogacy, providing procedural legitimacy through guidelines that facilitate its practice while simultaneously challenging its ethical viability via principles that underscore risks to dignity, vulnerability, equality and future well-being. Consequently, the analysis concludes that surrogacy, in its current form, encounters fundamental ethical obstacles under the UDBHR, necessitating further research and stringent international regulations to potentially align it with the declaration's comprehensive ethical imperatives, particularly in safeguarding women, embryos and children.
Open science offers numerous benefits for health research and innovation that can advance public healthcare in Africa. In addition to facilitating universal access to research results, open science engenders scientific collaboration, accelerating research and innovation. However, the shared entitlement to using and developing intellectual resources in the open science context is challenged by the traditional approach to intellectual property rights, at the core of which is the right to exclude. This article examines the emerging notion of inclusive property rights, an alternative regime that emphasises the right to include and collective entitlements, as opposed to the right to exclude and individual ownership. Under this sui generis inclusive property regime, everyone enjoys the rights to use, share, adapt, modify or improve protected creations or inventions stemming from open science. It is suggested that African countries should review their intellectual property legislation to explicitly take into account the notion of inclusive property rights, ensuring that the adoption of open science in health research and innovation is beneficial to the African people.
This article examines benefit sharing within health research, a subject of growing importance in South African regulatory and ethical frameworks. With reference to the National Health Act (NHA), this article builds on previous discussions about defining key terms in benefit sharing and offers health research ethics committees (RECs) in South Africa guidance in evaluating benefit-sharing provisions. It navigates three critical legislative frameworks - the Intellectual Property Rights from Publicly Financed Research and Development Act (IPRA), the Indigenous Knowledge Act (IKA) and the National Environmental Management: Biodiversity Act (NEMBA) - interpreting each for REC evaluation of research protocols involving publicly funded research, indigenous knowledge and non-human biological materials. The article also addresses the implications of section 60(4) of the NHA on benefit sharing for human participant research, dissecting questions around permissible forms of benefits to participants and research institutions. Through a decision-making diagram and two hypothetical scenarios, this article provides practical tools to help RECs assess and regulate benefit sharing in line with ethical and legal standards, ultimately promoting fair research practices.
The public sector provides healthcare access to 84% of patients in South Africa (SA). However, it is severely understaffed, with only 0.3 doctors per 1 000 people - far below the World Health Organization's recommended ratio of 2.5 per 1 000. While the public sector struggles with numerous challenges, including a critical shortage of healthcare personnel, SA has a high number of medical doctors who have completed their mandatory community service yet remain unemployed. The shrinking health budget, rising salaries and high number of medicolegal claims are some of the reasons why the National Department of Health (NDoH) cannot afford to employ these professionals. In addition, corruption has severely impacted available resources, creating dangerous conditions in public hospitals. During the State of the Nation Address, the SA President announced the development of new healthcare facilities, but buildings alone do not deliver healthcare - people do. If the NDoH is already struggling to fill posts in the public sector, how can communities trust that adequate human resources have been budgeted for new facilities? Without proper staffing, these new facilities could exacerbate existing workforce shortages. The fundamental right to access healthcare is affirmed in the Constitution; however, its implementation is riddled with impediments. Although the issue of unemployed doctors is part of a bigger crisis within the SA healthcare sector, it is imperative that it is tackled first in order to avoid the further collapse of the healthcare system. This article highlights the government's constitutional imperatives to the people of SA with regard to the right to access healthcare. It also brings to light certain factors that have accounted for the current state of healthcare in SA, and offers some recommendations toward urgent intervention. The article concludes by highlighting the need for strategic interventions that result in the integration of unemployed qualified doctors into the public healthcare system.
We examine whether South Africa's human papillomavirus (HPV) vaccination programme aligns with rule utilitarianism principles, considering ethical and societal dimensions. From a rule utilitarian perspective, we argue that the current policy should be revised to include boys because this change would generate greater overall benefit than the current exclusionary model. Specifically, we advocate for universal access to free HPV vaccinations for all eligible adolescents in South Africa. By using a framework grounded in rule utilitarianism, we aim to highlight the perceived unfairness and ethical concerns associated with excluding boys from the current school-based, free HPV vaccination programme. We assert that this exclusion undermines the programme's broader public health benefits and moral justifiability.
