In a recent public engagement study on heritable human genome editing (HHGE) conducted among South Africans, participants approved of using HHGE for serious health conditions—viewing it as a means of bringing about valuable social goods—and proposed that the government should actively invest resources to ensure everyone has equal access to the technology for these purposes. This position was animated by the view that future generations have a claim to these social goods, and this entitlement justified making HHGE available in the (...) present. This claim can be ethically justified in the Ubuntu ethic (deriving from South Africa) as it (a) emphasizes the interests of the community, and (b) espouses a metaphysical conception of the community that transcends the present generation and includes past and future generations. On this basis, a compelling claim can be made on behalf of prospective persons in favor of equal access to HHGE. (shrink)

BackgroundWhenever South African research institutions share human biological material and associated data for health research or clinical trials they are legally compelled to have a material transfer agreement in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health.Main bodyThe article offers a legal analysis of the SA MTA and focuses on its substantive fit with the broader legal environment in South Africa, and the clarity and practicality of its terms. The following problematic (...) aspects of the SA MTA are highlighted: Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; the SA MTA’s consent provisions are not aligned with extant law; and, similarly, its provision on donor ownership is misaligned with extant law; its creation of fictitious performance can only cause frustration on the part of an injured party; its benefit-sharing provision is vague and will have little practical effect; its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, its data privacy provision is insufficiently specific, is overbroad, and fails to provide terms that in general would facilitate the international sharing of human biological material and associated data in terms of existing privacy law.ConclusionsWhile some of the problematic aspects of the SA MTA are intricate and require consultative processes with stakeholders and others, to develop comprehensive solutions, most of the problematic aspects can be resolved immediately through amendments by the South African Minister of Health. The formulation of such amendments is proposed and, where possible, interim measures are suggested that may ameliorate the problems presented by the SA MTA. (shrink)

WHO in 2019 established the Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, which has recently published a Draft Governance Framework on Human Genome Editing. Although the Draft Framework is a good point of departure, there are four areas of concern: first, it does not sufficiently address issues related to establishing safety and efficacy. Second, issues that are a source of tension between global standard setting and state sovereignty need to be addressed in a (...) more nuanced fashion. Third, it fails to meaningfully engage with the extent to which the conceptualisation of human dignity may justifiably vary between jurisdictions. Fourth, the meaning of harm to the interests of a future person requires clarity. Provided these four areas of concern can be addressed, the future of the global governance of human genome editing may hold promise. (shrink)

This article points out a problematic lacuna in our law on surrogate motherhood, namely the lack of objective criteria for evaluating the suitability of a surrogate mother. The recent case of Ex Parte KAF – a case in which a surrogate motherhood agreement confirmation application was dismissed by the Johannesburg High Court – demonstrated how this lacuna can cause conceptual disjunction between the court and the clinical psychologist who evaluates the candidate surrogate mother. The solution suggested in this article is (...) that clinical psychologists who evaluate candidate surrogate mothers should give urgent and careful thought to identifying such objective criteria, and start explicitly articulating these criteria in the reports that they file in surrogate motherhood agreement confirmation applications. This practice will give the court the opportunity to engage with such criteria and to develop precedents in this regard. (shrink)

This article considers the practical question of how research institutions should best structure their legal relationship with the human genomic data that they generate. The analysis, based on South African law, is framed by the legal position that although a research institution that generates human genomic data is not automatically the owner thereof, it is well positioned to claim ownership of newly generated data instances. Given that the research institution exerts effort to generate the data, it can be argued that (...) it has a moral right to claim ownership of such data. Combined with the fact that it has an interest in having comprehensive rights in such data, it appears that the prudent policy for research institutions is to claim ownership of the human genomic data instances that they generate. This policy is tested against two opposing policy positions. The first opposing policy position is that research participants should own the data that relate to them. However, in light of data protection legislation that already provides extensive protections to research participants, bestowing data ownership on research participants would offer little benefit to such individuals, while leading to significant practical problems for research institutions. The second opposing policy position is that the concept of ownership should be abandoned in favour of data custodianship. This opposing position is problematic, as avoiding reference to ownership is a denial of legal reality and hence not a useful policy. Also, avoiding reference to ownership will leave research institutions with limited legal remedies in the event of appropriation of data by third parties. Accordingly, it is concluded that the wisest policy for research institutions is indeed to explicitly claim ownership of the human genomic data instances that they generate. (shrink)

This study critically examines the concept of benefit‐sharing in the context of health research involving human participants in South Africa, identifying a significant gap in the precision and application of terminology. It introduces a new terminological framework designed to provide clarity and facilitate standardisation in both national and international discourse on benefit‐sharing. The analysis extends to the complex legal landscape in South Africa, highlighting the nuances of mandated, permitted, and prohibited practices of benefit‐sharing across various statutes. This reveals substantial implications (...) for ethics committees, researchers, and participants, emphasising the need for a legal and ethical recalibration. Furthermore, the manuscript critiques South Africa's main ethics instruments for their inadequate guidance on benefit‐sharing and proposes recommendations for enhancing the Department of Health's ethics guidelines. By advocating for a coherent, legally informed approach to ethical decision‐making, the study underscores the need for integrating the proposed framework and legal insights into ethics guidelines. This comprehensive strategy aims not only to advance ethical practices within South Africa but also to contribute significantly to the global discourse on benefit‐sharing in health research. (shrink)

Artificial intelligence (AI) will drastically change the healthcare system. Radiology is one speciality that is most affected as AI algorithms are increasingly used in diagnostic imaging. AI‐enhanced health technologies will, inter alia, increase workflow efficiency, improve diagnostic accuracy, reduce healthcare‐related costs, and help alleviate medical personnel shortages in under‐resourced settings. However, the development of AI‐enhanced technologies in healthcare is fraught with legal, ethical, and human rights concerns. Currently, the use of AI in South African healthcare is not governed by sui (...) generis legislation or ethical guidance focused exclusively and specifically on AI, although various provisions and principles from law and ethics find application. This article outlines these normative principles and explains their relationship with the extant legal obligations and regulatory framework as applied to the use of AI in radiology services in South Africa. The article concludes with three key recommendations for radiology practitioners using AI in South Africa. These are the need for: vigilant monitoring of AI use in practice, reforms to the liability framework, and appropriate guidance from local regulators and the Health Professions Council of South Africa on the ethical use of AI. (shrink)

In 2021, the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing (the ‘Committee’) published its policy recommendations. It proposes, inter alia, a set of nine values and principles to inform the governance of human genome editing (HGE) and makes recommendations regarding how HGE can be regulated. While these proposals contain valuable contributions to the discourse on the global governance of HGE, they also contain elements that call for heightened attention to the risks (...) of the technology, and a countervailing focus on the potential benefits of the technology is missing. The Committee ostensibly prioritises restricting HGE technology in the interest of society as a collective but, in doing so, neglects to consider the interests and rights of individuals. In this article, we suggest that this approach is imbalanced insofar as it fails to give sufficient weight to the promise of this technology in considering the regulation of risks and disregards the importance of the fundamental liberties underlying the use of HGE in its discussion of values and principles that should guide governance. How this is problematic is illustrated with reference to the Committee's openness to using patents as HGE governance tools and its blanket rejection of ‘eugenics’. It is concluded that while the Committee makes some sensible recommendations on global governance, the Committee's approach of emphasising restrictions on HGE without also giving weight to the value of an open and liberal policy space is not something that liberal democratic states ought to follow. (shrink)

A complex network of ethico‐legal rules makes it difficult for health researchers in South Africa to lawfully recruit adolescents to the kinds of sensitive studies where it may be ethically appropriate to proceed without notifying parents or obtaining parental consent. This article responds to a recent proposal to amend the blanket requirement for mandatory parental consent presently contained in section 71 the South African National Health Act 61 of 2003 [NHA]. The proposed amendment is intended to bring the NHA into (...) alignment with South Africa's 2015 Department of Health Guidelines on Ethics in Health Research by permitting greater flexibility for a health research ethics committee to waive parental consent, and permit adolescents to consent independently. A lacuna in this proposal is highlighted with reference to the requirements of South Africa's Protection of Personal Information Act 4 of 2013 [POPIA]: Even if the NHA is amended as proposed, the goal of aligning South African law with prevailing ethics norms in South Africa would not necessarily be attained, as parental consent may still be required by POPIA. This article investigates whether this goal (of aligning the law with ethics) can be attained in a way that is compliant with POPIA. It is concluded that this is indeed possible in a number of ways, and that the best way to attain this goal is by requesting the South African Information Regulator to issue a guidance note to the effect that all health research projects that are approved by institutional health research ethics committees are to be regarded as being in the public interest, which would qualify such health research projects to be exempted from POPIA's consent requirements. (shrink)

An amendment to this paper has been published and can be accessed via the original article.

As is the case around the globe, South African fertility clinics face an ever‐expanding problem: what to do with the growing number of surplus cryopreserved embryos. Fertility clinics remain hesitant to destroy these abandoned embryos, partly because of concerns about the legal ramifications. This article clarifies the legal position in South Africa and offers practical recommendations to assist fertility clinics in managing abandoned embryos. In sum, fertility clinics cannot deem embryos as abandoned and discard them if fertility patients fail to (...) respond to a notice that the embryo storage agreement is about to expire. However, if there is non‐payment for embryo storage by fertility patients and the fertility clinic has informed the fertility patients of other options available to them with respect to their embryos, and there is still no response, the fertility clinic is legally entitled – and legally obliged – to discard the embryos. (shrink)

The South African National Health Research Ethics Council (NHREC) states in its 2024 Ethics Guidelines that human biological material (HBM) and data cannot be privately owned under South African law. This position conflicts with established legal principles, guidelines by the Health Professions Council of South Africa (HPCSA), and South African university policies, all of which support private ownership of HBM and data. Private ownership is not only legally sound but also ethically necessary, providing a framework for accountability, ensuring fair recognition (...) of institutional contributions, and enabling responsible custodianship over these valuable resources. The NHREC's denial of private ownership of HBM and data undermines South African research institutions’ ability to control their research assets and leaves them vulnerable to exploitation by foreign entities. The NHREC should issue a corrigendum to delete its incorrect position on private ownership of HBM and data. (shrink)