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)

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