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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 regulatory environment allows a regulatory path that would, in principle, permit research on human germline editing. However, the legal regulation of the clinical application of human germline editing is uncertain. As such, the current ethical and legal positions in South Africa are in need of reform. Five guiding principles – aligned with the values of the Constitution – are proposed to guide ethical and legal policy reform regarding human germline editing in South Africa: (1) Given its potential to improve the lives of the people of South Africa, human germline editing should be regulated, not banned. (2) Human germline editing clinical applications should only be made accessible to the public if they are proven to be safe and effective. (3) Non-therapeutic human germline editing may be permissible, and should be regulated in the same way as therapeutic human germline editing. (4) The decision on whether to use germline gene editing on a prospective child, should, subject to Principle 2, be left to the prospective parents. (5) Concerns about exacerbating social inequalities should be addressed by measures to increase access. In conclusion, recommendations are made to policymakers and scientists contemplating research in this field.
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 The 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. Conclusions While 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.
This article investigates how comics can be used to adequately communicate the correct process of contract cancellation and whether comics can enhance understanding of the legal process. A survey of pre-owned vehicle buyers of various levels of education in Pretoria, South Africa found that when comics are used to communicate contract cancellation, a significant increase in the comprehension of the legal cancellation process occurs. The results may influence how contracting parties may choose to communicate complex legal issues in future, specifically to consumers with little formal education or when parties are confronted with severe language barriers, which is highly relevant in a country such as South Africa with eleven official languages and generally low levels of education. The article argues that representatives tasked with explaining contractual content to contracting parties should consider making use of comics to aid them in their communication process to ensure proper understanding and execution of terms and conditions, which in turn may lead to fewer disputes and avoid expensive litigation.
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.
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 engagement (DPE) methodology, entailing inter alia that measures were put in place to ensure that potential participants became informed about HHGE, and that deliberations between the participants were facilitated with the aim of seeking consensus. A diverse group of 30 persons was selected to participate in the DPE study, which took place via Zoom over three consecutive weekday evenings. The main results are: Provided that HHGE is safe and effective, an overwhelming majority of participants supported allowing the use of HHGE to prevent genetic health conditions and for immunity against TB and HIV/Aids, while significant majorities opposed allowing HHGE for enhancement. The dominant paradigm during the deliberations was balancing health benefits (and associated improvements in quality of life) with unforeseen health risks (such as loss of natural immunity). The seriousness of a health condition emerged as the determining factor for the policy choice of whether to allow an application of HHGE. More generally, equal access to HHGE qua healthcare service featured as an important value, and it was uncontested that the South African government should allocate resources to promote scientific research into HHGE. These results are aligned with the policy principles for regulating HHGE in South Africa suggested by Thaldar et al. They call for urgent revision of South African ethics guidelines that currently prohibit research on HHGE, and for dedicated HHGE legal regulations that provide a clear and comprehensive legal pathway for researchers who intend to conduct HHGE research and clinical trials.
Considered in isolation, the ethical and societal challenges posed by genomics and artificial intelligence (AI) are profound and include issues relating to autonomy, privacy, equality, bias, discrimination, and the abuse of power, amongst others. When these two technologies are combined, the ethical, legal and societal issues increase substantially, become much more complex, and can be scaled enormously, which increases the impact. Adding to these complexities, both genomics and AI-enabled technologies are rife with scientific and technological uncertainties, which makes the regulation of these technologies not only challenging in itself, but also creates legal uncertainties. In science, the precautionary principle has been used globally to govern uncertainty, with the specific aim to prevent irreversible harm to human beings. The regulation of uncertainties in AI-enabled technologies is based on risk as set out in the AI Regulation that was recently proposed by the European Commission. However, when genomics and artificial intelligence are combined, not only do uncertainties double, but the current regulation of such uncertainties towards the safe use thereof for humans seems contradictory, considering the different approaches followed by science and technology in this regard. In this article, I explore the regulation of both scientific and technological uncertainties and argue that the application of the precautionary principle in the context of human genomics and AI seems to be the most effective way to regulate the uncertainties brought about by the combination of these two technologies.
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