CORRESPONDENCE

 

Right of reply - Response to: In defence of South Africa's National Health Research Ethics Council guidelines on heritable human genome editing

 

 

To the Editor: The repeated attempts by Thaldar et al. to establish heritable human genome editing (HHGE) as legal, ethically acceptable and aligned with South African (SA) cultural values are scientifically premature, ill-informed and dangerous. In their response to our editorial, they rely on rigid, legal technicalities to achieve their argument that HHGE is already legally permissible. We did not ignore the importance of 'statutory formatting' in our editorial, but -as we pointed out - recognise that such formatting in itself does not determine the legality or otherwise of new scientific practices. To reiterate our argument: while the concept of HHGE was not yet conceived when the legislation was drafted, the intent is clear in that the outcome of live human births following genetic manipulation (as would be the case for HHGE) should not be permitted. As with human reproductive cloning (referred to in section 57(1) of the National Health Act No. 61 of 2003),^[1] there is no indication that HHGE will become a reality, and it is irrational to claim that HHGE could fall into the same category as in vitro fertilisation (IVF) and other common practices in fertility healthcare. We are not alone in our perspective: on the contrary, our views are supported by international guidelines and recommendations by scholars who are experts in the fields of genetics, ethics, philosophy, regulation of scientific interventions and children's rights.

Although we address only three points related to the editorial by Thaldar et al., so as not to repeat the views we expressed in the Ramsay et al. SAMJ editorial,^[2] this does not infer that we agree with their remaining points.

First, although it may appear proactive to develop guidelines that are 'future ready' and that uphold Constitutional values, whether HHGE is indeed part of our human future is still up for debate. To purport otherwise - or to point out that 'HHGE should be seriously considered' if it could, theoretically, help to address a public health crisis - may be an academically interesting exercise, but ignores fundamental realities of healthcare in SA and scientific advances globally. Arguing that 'future-ready' legislation could allow us to be ready to act when the technology is validated is therefore misguided, as the substantive ethicolegal concerns still require critical engagement.

Second, SA is part of a global community, and ignoring international guidelines and recommendations on HHGE or dismissing them because 'the WHO (World Health Organization) guidelines appear to be less directly applicable to the SA context, as they may not fully account for its unique realities and constitutional imperatives' both reflects a lack of understanding of the purpose of the guidelines, and ignores that they were drafted with the input of several South Africans.^[3,4] Furthermore, it constitutes a failure to intellectually engage appropriately with the issues.

Third, in our editorial, we expressed concerns regarding the academic rigour of some of this group's work. Building on this critique, we now draw attention to the pervasive reliance on self-citation as a strategy to bolster their arguments, including in their response to our editorial. A more balanced approach requires substantive engagement with academic literature.

On 11 December 2024, the Southern African Society of Human Genetics hosted an Indaba titled 'Ethical, legal, and social implications of heritable human genome editing: A South African perspective'.^[5,6] Over 115 participants, including genetic health professionals, genetic scientists, legal experts and ethicists, overwhelmingly expressed concern and dismay at both the tone and the substance of the approach of Thaldar et al. in the current debate over HHGE in the country. Importantly, National Health Research Ethics Council (NHREC) members present at the Indaba recognised the concerns raised, and committed to initiating the process for amending the section on HHGE in the South African Ethics in Health Research Guidelines: Principles, Processes and Structures (3rd ed.)^[7] through a consultative process.

Our interpretation and views consider a broad range of factors on HHGE that have direct bearing on society at large, and that are echoed both by the local community and by international guidance.

Michèle Ramsay

Director, Sydney Brenner Institute for Molecular Bioscience, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

Michele.Ramsay@wits.ac.za

Michael S Pepper

Director, SAMRC Extramural Unit on Stem Cell Research and Therapy, and Director, Institute for Cellular and Molecular Medicine, Faculty of Health Sciences, University of Pretoria, South Africa

Janlina de Vries

Director, The EthicsLab, University of Cape Town, South Africa

Safia Mahomed

Department of Jurisprudence, School of Law, University of South Africa, Pretoria, South Africa

Eleni Flack-Davison

Head: Research Legal, Compliance and Integrity, University of the Witwatersrand, Johannesburg, South Africa

 

References

1. South Africa. National Health Act No. 61 of 2003.         [ Links ]

2. Ramsay M, Pepper M, de Vries J, Mahomed S, Flack-Davison E. Heritable human genome editing in South Africa - time for a reality check. S Afr Med J 2025;115(1):e2872. https://doi.org/10.7196/SAMJ.2025.v115i1.2872        [ Links ]

3. World Health Organization Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. Report of the third meeting, Cape Town, South Africa, 25 - 26 February 2020. Geneva: World Health Organization, 2021. https://iris.who.int/bitstream/handle/10665/345252/9789240028494-eng.pdf?sequence=1 (accessed 20 January 2025).         [ Links ]

4. National Academies of Science, Engineering and Medicine. International commission on the clinical use of human germline genome editing. NASEM, 2025. https://www.nationalacademies.org/our-work/international-commission-on-the-clinical-use-of-human-germline-genome-editing (accessed 20 January 2025).         [ Links ]

5. Scientists call for revision on South Africa's guidelines on genome engineering. Nature News Africa. 14 January 2025. https://www.nature.com/articles/d44148-025-00006-7 (accessed 20 January 2025).         [ Links ]

6. Southern African Society for Human Genetics. SASHG committee consensus statement on heritable human genome editing. SASHG, 2025. https://sashg.org/wp-content/uploads/2025/01/SASHG-Committee-Consensus-statement-on-HGGE-Indaba-20241213.pdf (accessed 30 January 2025).         [ Links ]

7. National Health Research Ethics Council. South African Ethics in Health Research Guidelines -Principles, Processes and Structures. 3rd ed. Pretoria: National Department of Health, 2024. https://www.health.gov.za/nhrec-guidelines/ (accessed 20 January 2025).         [ Links ]