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.
 Significance:
 
 The ethical and legal positions regarding human germline editing in South Africa are comprehensively analysed. Furthermore, five guiding principles – aligned with the values of the Constitution – are proposed to guide much needed ethical and legal policy reform regarding human germline editing in South Africa.
Highlights
Human germline editing holds the promise of significant benefit, and harbours secrets of yet unknown possible genetic risks and consequences for future generations.[1]
Modern techniques used in genome editing are more precise than those that have in the past been used to genetically modify organisms, and include technologies such as CRISPRCasX, zinc finger nuclease (ZFN) transcription activator-like-effector based nucleases (TALEN) and meganucleases.[10,11]
The Health Professions Council of South Africa (HPCSA) does not define exactly what it means by ‘therapy’, it appears from the reasoning that the intention is to ban all forms of human germline editing research – and per implication the clinical application thereof
Summary
Human germline editing holds the promise of significant benefit, and harbours secrets of yet unknown possible genetic risks and consequences for future generations.[1]. What is South Africa’s current position in terms of legal and ethical regulation of human germline editing? A further differentiation is relevant, namely between research on human germline editing and the clinical application of human germline editing. With ‘clinical application’ we refer to the use of modified germ cells in human reproduction. This will include clinical trials and – if shown to be safe and effective – the provision of human germline editing as a service to the public
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