Donrich Thaldar

University of KwaZulu-Natal | ukzn · School of Law

This is version 1.0 of a data transfer agreement (DTA) for use by the South African research community, together with an explanatory memorandum.

The regulation of surrogacy in South Africa centres on a scheme of judicial confirmation of surrogacy agreements before the start of the surrogate pregnancy. If such confirmation is granted by the court, actions taken in the execution of the surrogacy agreement are lawful, and the agreement itself is enforceable. Against this background, the questi...

This paper reports the results of a public engagement study on heritable human genome editing (HHGE) carried out in South Africa, which was conducted in accordance with a study protocol that was published in this journal in 2021. This study is novel as it is the first public engagement study on HHGE in Africa. It used a deliberative public engageme...

This article provides a comprehensive analysis of the various dimensions in South African law applicable to personal genomic sequence data. This analysis includes property rights, personality rights, and intellectual property rights. Importantly, the under-investigated question of whether personal genomic sequence data are capable of being owned is...

The recent case of QG v CS (32200/2020) 2021 ZAGPPHC 366 (17 June 2021) concerns a sperm donor who applied to the court for parental responsibilities and rights in respect of a child conceived with his sperm. This is despite the fact that he had concluded a written agreement with the child’s legal parents before the child’s conception which stipula...

Despite the growing popularity of direct-to-consumer genetic testing, there is minimal South African literature on the topic. The limited available research suggests that direct-to-consumer genetic testing is unregulated. However, we suggest that direct-to-consumer genetic testing is indeed regulated, and unusually so. The first step in the process...

South African fertility clinics often include a provision in their consent forms that deals with the disposition of reproductive material (gametes and embryos) after a fertility patient’s death. This practice is problematic as such a provision is not legally valid. If the clinic acts in pursuance of such a provision upon a fertility patient’s death...

Despite the growing popularity of direct-to-consumer genetic testing, there is minimal South African literature on the topic. The limited available research suggests that direct-to-consumer genetic testing is unregulated. However, we suggest that direct-to-consumer genetic testing is indeed regulated, and unusually so. The first step in the process...

Despite the tremendous promise offered by artificial intelligence (AI) for healthcare in South Africa, existing policy frameworks are inadequate for encouraging innovation in this field. Practical, concrete and solution-driven policy recommendations are needed to encourage the creation and use of AI systems. This article considers five distinct pro...

South African (SA) gamete banks and gamete donation agencies do not offer open-identity donors, as it is generally believed that donor anonymity is a legal requirement in SA. However, analysis of SA statutory instruments and case law shows that this belief is mistaken, and that gamete donation in SA can be anywhere on the spectrum between anonymous...

SIGNIFICANCE: In the research context, a 'responsible party' as contemplated in terms of POPIA is typically the research institution as well as the individual researcher involved. Given the potential civil liability that individual researchers could face, we suggest that the Code of Conduct for Research should place a duty on research institutions...

SIGNIFICANCE: 'Public interest' is an important concept in POPIA. However, the way in which it has been interpreted by the Information Regulator is subject to criticism. A better interpretation is suggested.

Medies-geassisteerde voortplanting in Suid-Afrika word tans gereguleer deur regulasies wat in 2012 gepromulgeer is ingevolge die Nasionale Gesondheidswet 61 van 2003. In Maart 2021 het die minister van Gesondheid nuwe konsepregulasies gepubliseer vir kommentaar. Hierdie artikel ontleed die nuwe konsepregulasies teen die agtergrond van groeiende reg...

Patenting activity regarding new CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) genome editing technology has mushroomed to create a vast and complex patent landscape. However, because of South Africa’s current depository patent system, the South African CRISPR patent landscape contains foundational patents with overlapping clai...

COVID-19 exposed flaws in the law regulating the sharing of data and human biological material (HBM). This poses obstacles to the epidemic response, which needs accelerated public health research and, in turn, efficient and legitimate HBM and data sharing. Legal reform and development are needed to ensure that HBM and data are shared efficiently an...

The global discourse on heritable genome editing is dominated by Western perspectives. A broadening of this discourse is advocated. A South African perspective on heritable genome editing is provided, focusing on differences in culture and context , which illustrates the need for a governance approach to heritable genome editing that is distinctly...

Whether human biological material (‘HBM’) in the research context is susceptible of ownership is contested, yet under-investigated. This situation leads to legal uncertainty for local scientists and their international collaborators. This article presents a comprehensive analysis of the topic — investigating both common law and statutory law — and...

This article outlines the protocol for a prospective study for virtual deliberative public engagement on heritable genome editing in humans. The study intends to create a platform for a diverse group of 25–30 South Africans to engage with a facilitator and each other on 15 policy questions regarding heritable genome editing, with a focus on: a) the...

In July 2021 South Africa became the first jurisdiction in the world to grant a patent where the inventor is not human, but an artificial intelligence (AI). The AI creativity machine in question, called DABUS, which was made by American entrepreneur Dr Stephen Thaler, invented a new food container. Thaler applied for a patent on this invention in v...

The Protection of Personal Information Act 4 of 2013 (hereafter POPIA) has the potential to disrupt health research in South Africa. While the legal status quo is that broad consent by research participants is acceptable, POPIA requires specific consent for any processing of research participants' health and genetic information. However, POPIA offe...

Development of a Country report on the measures implemented to combat the impact of COVID-19 in South Africa.

A complete discussion of the South African law and regulations that governs Human Biological Material.

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 iss...

Despite the fact that the Constitution explicitly protects the right to freedom of scientific research, this right features neither in the preamble to any legislation, nor in any reported case law. If the right to freedom of scientific research remains in obscurity, South Africa could slip into totalitarian control of the scientific enterprise, to...

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

Human germline editing holds much promise for improving people’s lives, but at the same time this novel biotechnology raises ethical and legal questions. The South African ethics regulatory environment is problematic, as it prohibits all research on, and the clinical application of, human germline editing. By contrast, the South African legal regul...

Background: Whenever South African (SA) 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 (MTA) in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health (SA MTA). Main body:...

In 2018, the South African Minister of Health gazetted a material transfer agreement (SA MTA) that must be used as a framework whenever a researcher based in South Africa is involved in the transfer of human biological material. The SA MTA therefore impacts not only on the South African research community, but also its international research partne...

Quarantine is a very effective method for containing the spread of highly infectious diseases in large populations during a pandemic, but it is only effective if properly implemented. The co-operation and compliance of people entering quarantine are critical to its success. However, owing to the isolating and social distancing nature of quarantine,...

Quarantine is a very effective method for containing the spread of highly infectious diseases in large populations during a pandemic, but it is only effective if properly implemented. The co-operation and compliance of people entering quarantine are critical to its success. However, owing to the isolating and social distancing nature of quarantine,...

In this case note we make two salient observations regarding the recent Supreme Court of Appeal judgment in Beukes v Smith. First, the judgment shows that when assessing alleged wrong fulness, the court is concerned with whether the health-care user did in fact provide informed consent, and not with formalities such as making notes of consultations...

The Protection of Personal Information Act No. 4 of 2013 (POPIA) promises a new dispensation of privacy protection for research participants in South Africa. In a recent article, Staunton et al. proposed that a purposive interpretation of POPIA would allow for the retention of the status quo of broad consent in the context of genomic research. In t...

Letter by Thaldar and Townsend, following an article by the same authors (Thaldar D, Townsend B. Genomic research and privacy: A response to Staunton et al. S Afr Med J 2020;110(3):172-174. https://doi.org/10.7196/SAMJ.2020.v110i3.14431) and both commenting on an article by Staunton et al. (Staunton C, Adams R, Botes M, et al. Safeguarding the futu...

If the safety and efficacy issues relating to heritable genome editing can be resolved, how should liberal democratic societies regulate the use of this technology by prospective parents who wish to effect edits to the genomes of their prospective children? We suggest that recent developments in South African law can be useful in this regard. The c...

Biobanks (organised collections of human biological material and associated information stored for research purposes) are becoming invaluable to human health research. However, concerns have been voiced in the literature that POPIA – the new legislation that aims to protect personal information – may stymie the functioning of South African biobanks...

In 2012 the Minister of Health made the Regulations Relating to the Artificial Fertilisation of Persons, which provide that the woman who intends to be made pregnant with an in vitro embryo owns such an embryo and can control the embryo's fate in specified ways. Given that in vitro embryos are outside the woman's body, the rationale for these provi...

The objective of this study was to gain information from egg donors in South Africa (SA) which could be pertinent to policy development on egg donation. The study was conducted on egg donors in the database of a Cape Town-based egg donation agency who donated within a year preceding the study. 150 egg donors from the population of 226 participated...

In AB v Minister of Social Development, the applicants challenged extant law that requires surrogacy commissioning parents to use their own gametes for the conception of a child, rather than donor gametes. The majority of the Constitutional Court rejected the challenge on the basis that a child has the right to know his/her genetic origins. The bas...

South Africa, like many other countries, outlaws non-therapeutic preimplantation sex selection. The arguments regarding the permissibility of preimplantation sex selection should be contextualised to South Africa. In particular, one must have due regard to how the values that inform these arguments have been interpreted in South African human right...

AB v Minister of Social Development centred on the application of the best interests of the child principle to surrogate motherhood and the use of donor gametes. Given the sensitive and emotional nature of the subject, AB was a litmus test for South Africa’s courts’ commitment to the rule of law. This article examines the evidence submitted by both...

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...

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...

Posthumous conception – when a deceased person’s gametes are used for procreative purposes – made its debut in South African (SA) courts in NC v Aevitas Fertility Clinic. A widow was granted the right to use her deceased husband’s sperm for procreation. Against the background of legislative ambiguity, this case creates legal certainty that posthumo...

I reply to Dr Donkin’s response to my article ‘Human dignity and the future of the voluntary active euthanasia debate in South Africa’.

In the landmark case of Brüstle v Greenpeace, the European Court of Justice (ECJ) was confronted with pertinent moral and legal dimensions of embryonic stem cell research – in particular, the application of human dignity to the human embryo. Given the centrality of human dignity in South African human rights law, and the novelty of the application...

It is constitutionally impermissible for legislation to over-medicalise, that is, to legally enforce medical influence and supervision over certain actions, without good reason why such medical influence and supervision are required. Various parts of the regulations relating to artificial fertilisation of persons made in terms of the National Healt...

The issue of voluntary active euthanasia was thrust into the public policy arena by the Stransham-Ford lawsuit. The High Court legalised voluntary active euthanasia – however, ostensibly only in the specific case of Mr Stransham-Ford. The Supreme Court of Appeal overturned the High Court judgment on technical grounds, not on the merits. This means...

In their original article on the subject of research using human biological material, Mahomed, Nöthling-Slabbert and Pepper advanced the notion that the law regarding ownership of human biological material is uncertain, and proposed that our country’s healthcare policy of altruism be changed to mandatory profit-sharing by research participants. In...

Cross-jurisdiction egg donation has become a controversial topic, giving rise to ethical and legal concerns. This article analyses the legal ramifications of cross-jurisdiction egg donation from a South African perspective, with particular focus on the role played by egg donation agencies. It is legal for egg donation agencies to recruit for altrui...

The principle of res judicata is well-established in our law: essentially it means that parties to a dispute have only one metaphorical "bite at the cherry". The "bite" can entail appealing through the hierarchy of courts, but once the parties have exhausted their appeals, they cannot re-litigate the same dispute. However, in the recent case of Mol...

The threshold requirement for surrogate motherhood entails that a commissioning parent or parents must be permanently unable to give birth to a child. The question of whether a commissioning mother who suffers from a permanent illness that does not cause infertility as such, but that renders pregnancy a significant health risk to such mother and/or...

Social justice in the context of research using human biological material is an important contemporary legal-ethical issue. A question at the heart of this issue is the following: Is it fair to expect a research participant (a person who participates in such research by, among others, making available biological material from his or her body) to pa...

Surrogacy is not regulated by a single legal instrument only, nor is confirmation of a surrogacy agreement by the High Court an unqualified green light for the surrogacy process to proceed. In the context of the HIV status of the commissioning father, whose gametes are to be used for the conception of the child in pursuance of a surrogacy agreement...

This article attempts to answer the question of whether stem cell therapy falls within the current South African regulatory framework, using the Regenexx case in the USA as an example. The USA regulator, the Federal Drug Administration (FDA), is seeking to regulate the Regenexx autologous stem cell therapy as a 'drug' and a 'biological product'. Th...

This article analyses the regulation of autologous stem cell (ASC) therapy in South Africa. The analysis is structured in three parts: In the first part of the analysis it is argued that ASC preparations qualify qua registrable medicine in the subclass of biological medicine within the regulatory framework established by the Medicines and Related S...

THIS PAPER CRITICALLY ANALYZES the arguments that Fukuyama develops in Our Posthuman Future: Consequences of the Biotechnology Revolution. Fukuyama's main argument proposes that human nature, which is defined as species-typical genetic characteristics, is the ultimate basis for human values, specifically for our species' special value-our human dig...

Stem cell banking is a complex and controversial subject. There are currently three private stem cell banks in South Africa. At present, South Africa does not have a public stem cell bank. The de facto legal vacuum in which the private banks have operated thus far will change at some point in the future following the publication, for public comment...

The traditional focus ofpre-embryo research on reproductive problems has since radically expanded due to the advent of embryonic stem cell research. Similar to other countries, pre-embryo research in South Africa is also subject to a legal-ethical regime that strictly regulates pre-embryo research. This paradigm is based on the value 'respect for t...

The genetic revolution will have a profound impact on human society and therefore on the public policy environment. This article aims to describe the public policy paradigms and paradigm shifts that will determine the framework for dialogue - public policy discourse - on an abstract conceptual level. The genetic revolution will place the determinat...

Human preimplantation genetic screening and selection (PGSS) is a foreseeable near-future procreative technology that will soon enable prospective parents to obtain a complete genetic profile of a substantial number of in vitro-fertilized pre-embryos, based on which, selections can be made for implantation in utero. In this paper, the ethical consi...