Is benefit sharing with research participants lawful in South Africa? An unexplored question in the governance of genomics research.

Despite advocacy in favour of benefit sharing with research participants in genomics research that is conducted in South Africa, there has been little critical legal engagement with this concept. That is what this article provides by posing the hitherto unexplored-but foundational-question: Is benefit sharing with research participants lawful in South Africa? The answer is clearly 'no'. South African law provides that it is unlawful to provide any financial or other reward to research participants for donating biospecimens-except for reimbursement of reasonable costs incurred. Accordingly, benefit sharing would be unlawful. The ramifications of this conclusion are far-reaching. Most pertinently, should any benefit-sharing agreements with research be put into practice, such agreements would be unenforceable and would expose all parties involved-including foreign collaborators-to criminal prosecution. The solution for proponents of benefit sharing in South Africa would be to lobby the South African government to revise the relevant law. However, as long as the law remains as it currently is, institutions and individuals all over the world who are involved in genomics research in South Africa would be well advised to comply with the law by not engaging in benefit sharing with research participants.

An imbalanced approach to governance? An analysis of the WHO's position on human genome editing.

In 2021, the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing (the 'Committee') published its policy recommendations. It proposes, inter alia, a set of nine values and principles to inform the governance of human genome editing (HGE) and makes recommendations regarding how HGE can be regulated. While these proposals contain valuable contributions to the discourse on the global governance of HGE, they also contain elements that call for heightened attention to the risks of the technology, and a countervailing focus on the potential benefits of the technology is missing. The Committee ostensibly prioritises restricting HGE technology in the interest of society as a collective but, in doing so, neglects to consider the interests and rights of individuals. In this article, we suggest that this approach is imbalanced insofar as it fails to give sufficient weight to the promise of this technology in considering the regulation of risks and disregards the importance of the fundamental liberties underlying the use of HGE in its discussion of values and principles that should guide governance. How this is problematic is illustrated with reference to the Committee's openness to using patents as HGE governance tools and its blanket rejection of 'eugenics'. It is concluded that while the Committee makes some sensible recommendations on global governance, the Committee's approach of emphasising restrictions on HGE without also giving weight to the value of an open and liberal policy space is not something that liberal democratic states ought to follow.

Promoting Equality in the Governance of Heritable Human Genome Editing through Ubuntu: Reflecting on a South African Public Engagement Study.

In a recent public engagement study on heritable human genome editing (HHGE) conducted among South Africans, participants approved of using HHGE for serious health conditions-viewing it as a means of bringing about valuable social goods-and proposed that the government should actively invest resources to ensure everyone has equal access to the technology for these purposes. This position was animated by the view that future generations have a claim to these social goods, and this entitlement justified making HHGE available in the present. This claim can be ethically justified in the Ubuntu ethic (deriving from South Africa) as it (a) emphasizes the interests of the community, and (b) espouses a metaphysical conception of the community that transcends the present generation and includes past and future generations. On this basis, a compelling claim can be made on behalf of prospective persons in favor of equal access to HHGE.

The multidimensional legal nature of personal genomic sequence data: A South African perspective.

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 investigated and answered affirmatively. In addition to being susceptible of ownership, personal genomic sequence data are also the object of data subjects' personality rights, and can also be the object of intellectual property rights: whether on their own qua trade secret or as part of a patented invention or copyrighted dataset. It is shown that personality rights constrain ownership rights, while the exploitation of intellectual property rights is constrained by both personality rights and ownership rights. All of these rights applicable to personal genomic sequence data should be acknowledged and harmonized for such data to be used effectively.

A deliberative public engagement study on heritable human genome editing among South Africans: Study results.

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.

Future of global regulation of human genome editing: a South African perspective on the WHO Draft Governance Framework on Human Genome Editing.

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.

A virtual deliberative public engagement study on heritable genome editing among South Africans: Study protocol.

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 prevention of heritable genetic conditions; b) editing for immunity; and c) editing for enhancement. The aim is to understand the views on these issues so as to inform further research and policy, and to analyse the process and effect of deliberation on opinion. Participants will be expected to study the provided resource materials and pass the entrance exam-aligning with the protocols of the Harvard Personal Genome Project. In this way, the commitment, openness and basic knowledge of the candidates will be tested to ascertain whether they are suitable participants for the deliberative engagement.

Does human germline genome editing violate human dignity? An African perspective.

It has been variously claimed that alterations to the human genome for reproductive purposes ought to be prohibited on the basis that doing so is contrary to human dignity. This claim leads to the conclusion that germline genome editing (GGE) ought to be categorically banned in all states committed to upholding human dignity as a right recognized in international human rights documents, and which has been entrenched in the constitutions of many liberal democracies. But is it the case that the right to human dignity is necessarily opposed to GGE? This paper explores this question through critical examination of the concept of human dignity in international human rights, and how it has been interpreted by individual states. Recognizing that the interpretation of human dignity is shaped by cultural context, the paper explores an African perspective on this issue, using South African constitutional jurisprudence on human dignity as an example. It concludes that when viewed through the lens of the African ethic of Ubuntu, there is no justification for a categorical prohibition on GGE, on the grounds that it is contrary to human dignity. This illustrates the need for a global discourse on the regulation on genome editing to be sensitive to varying perspectives-specifically on value-laden questions such as the interpretation of human rights.

Procreative Non-Maleficence: A South African Human Rights Perspective on Heritable Human Genome Editing.

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 country's apex court recently recognized as a legal principle that the scope of possible reproductive decisions that parents may make when using new reproductive technologies excludes decisions that will cause harm to the prospective child-the principle of procreative non-maleficence. We suggest that the principle of procreative non-maleficence provides a mechanism for striking an equitable balance between two competing interests that are given legal recognition in most liberal democracies: the reproductive rights of prospective parents and the state's duty to protect child welfare.