Why POPIA does not apply to DNA

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The in Vitro Embryo and the Law: The Ownership Issue and a Response to Robinson

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 provisions cannot be to protect the woman's bodily integrity. These provisions are, however, problematic from a constitutional perspective, as they: exclude fathers across the board, and impede the right of all intended parents who will not gestate the pregnancy, like surrogacy commissioning parents, to make decisions regarding reproduction – which include the right not to reproduce and hence to veto the further use of an in vitro embryo for reproductive purposes. Robinson argues that the legislative intent with the 2012 Regulations was not to establish ownership of in vitro embryos, and that in vitro embryos are not legal objects (or subjects), but rather form part of the legal subjectivity of their parents. I respond that the language used in the relevant provision is plain and clear in establishing ownership of in vitro embryos, and that in vitro embryos are therefore legal objects. I further suggest that Robinson's proposition of in vitro embryos forming part of the legal subjectivity of their parents may address the gender equality concern with the 2012 Regulations, but that it in turn causes other problems. In particular, Robinson's rationale for his proposition is problematic, as it appears to conflate the embryo with the prospective child. I rely on the important recent judgment in Ex Parte KAF 2019 2 SA 510 (GJ) that held explicitly that the in vitro embryo should not be equated with the prospective child. Finally, I respond to Robinson's critique of my 2005 article, by clarifying the research questions and answers of that article. I highlight the importance of the moral status of the in vitro embryo to legal and ethical debates relating to the in vitro embryo, and invite academic debate on the topic. &nbsp

The need to develop objective criteria for suitability as a surrogate mother: Reflections on Ex Parte KAF

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

Does data protection law in South Africa apply to pseudonymised data?

The use of pseudonymised datasets is increasingly commonplace as research institutions seek to balance data utility with data security. Yet, a crucial question arises: How does South Africa’s Protection of Personal Information Act (POPIA) govern these datasets, especially given their ambiguous state between de-identification and possible re-identification? A thorough examination of POPIA suggests that the determination of whether a pseudonymised dataset is personal information—and thus whether processing the dataset falls within POPIA’s purview—must be informed by the specific context of the responsible party in possession of the pseudonymised dataset. When a research institution retains both the pseudonymised dataset and its linking dataset, the pseudonymised dataset remains identifiable and is thus personal information that falls within POPIA’s purview. However, when only the pseudonymised dataset—without the linking dataset—is transferred to another entity, it is non-personal information in the hands of such a recipient, thus freeing the recipient from POPIA compliance. Such a delineation offers research institutions greater flexibility in sharing and using pseudonymised datasets. Importantly, because the original provider of the pseudonymised dataset (who has the means to re-identify the dataset) remains governed by POPIA, the privacy rights of data subjects are not undermined

CRISPR: Challenges to South African biotechnology law

Genome editing using newly discovered tools such as CRISPR-Cas9 offers the potential to modify the genetic make-up of plants, non-human animals and humans in exact ways. Such genetic modification can serve the purpose of correcting gene defects, and can enhance certain characteristics. Apart from reigniting old ethical debates, genome editing also poses a particular challenge to legal practitioners, as this new technology does not always fit into existing definitional moulds, and it lacks clear legal precedent. In this article, we identify the most salient areas of concern in the South African legal context

Protecting personal information in research: Is a code of conduct the solution?

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Correction to:South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation

Correction to: BMC Medical Ethics (2020) 21:85 https://doi.org/10.1186/s12910-020-00526-

South Africa’s new standard material transfer agreement:proposals for improvement and pointers for implementation

BackgroundWhenever 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 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: (a) Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; (b) Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; (c) the SA MTA’s consent provisions are not aligned with extant law; and, similarly, (d) its provision on donor ownership is misaligned with extant law; (e) its creation of fictitious performance can only cause frustration on the part of an injured party; (f) its benefit-sharing provision is vague and will have little practical effect; (g) its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; (h) it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, (i) 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