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)

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)

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.

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)