Human germline editing: Legal-ethical guidelines for South Africa

Abstract

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.

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

“…21 In this context, it is also important to note that there may be morally defensible reasons for choosing to use human genome editing technology, such as to avoid heritable disease in a way that does not require the destruction of unused embryos. 22 For these reasons, we recommend that the final Framework should more clearly recognise that the concept 'human dignity' is subject to more than one interpretation, and explicitly consider the policy implications of not only dignity as restraint, but also of dignity as empowerment.…”

Is South Africa ready for the future of human germline genome editing? Comparing South African law and recent proposals for global governance

“…In this section, the article compares SA law on heritable genome editing with the WHO draft governance framework, using the five principles proposed by Thaldar et al [4] as guidance for how genome editing should be regulated in SA. This discussion will focus primarily on the regulation of the potential clinical applications of germline editing.…”

“…Reproductive cloning has been defined as 'the manipulation of genetic material in order to achieve the reproduction of a human being' . Thaldar et al [4] have argued that while human germline editing cannot be regarded as cloning per se, germline editing involves the manipulation of genetic material, and hence it may be construed that such activities fall within the scope of 'human reproductive cloning' as defined by the NHA, thereby rendering it illegal. Whereas a different interpretation can be inferred by applying principles of statutory interpretation, the absence of case law renders the position unclear.…”

“…Whereas a different interpretation can be inferred by applying principles of statutory interpretation, the absence of case law renders the position unclear. [4] Then again, the Health Professions Council of South Africa (HPCSA) [7] prohibits research relating to germline gene therapy but is silent on the clinical application of germline editing. And so, the major regulatory challenge that ought to be addressed is: should human germline editing be allowed in SA, and if so, under what conditions?…”

“…[2] This framework provides insight into what global regulation on human germline genome editing may be, and in this article, we compare the recommendations of the WHO advisory committee against SA's current legal framework. Recognising that SA policy on human germline genome editing is currently unclear and in need of reform, [3] we will analyse the draft framework through the lens of the five principles proposed by Thaldar et al [4] These principles assist in providing systematic guidance on what SA policy formation on human germline genome editing should entail in light of prevailing ethical principles, legal norms and human rights.…”