South Africa may allow heritable human genome editing

In a significant update to its health research ethics guidelines, South Africa has introduced a new framework covering heritable human genome editing.

While not explicitly allowing this channel of research the guidelines, published in May by South Africa's Department of Health, are much less stringent than those seen previously from other guiding bodies such as WHO and UNESCO (see BioNews 1103).

The Department of Health acknowledges that heritable human genome editing 'holds significant potential for addressing genetic diseases and improving human health,' and emphasises the importance of rigorous ethical oversight, and the need for thorough risk assessments.

Heritable, or germline, human genome editing involves making genetic modifications to eggs, sperm or embryos, which would be passed down to future generations. Currently no country explicitly permits the practice in clinical settings, and guidelines in China were tightened following the Dr He Jiankui scandal in 2018 (see BioNews 977 and 1182) and reviewed earlier this year (see BioNews 1247 and 1251).

South Africa's new guidelines allow room for research into heritable human genome editing, but stipulate that any such research must undergo a comprehensive ethical review. Risks and societal impacts must be carefully evaluated, and the research should only proceed if it is determined to have clear, demonstrable benefits for the individual and society, with strict oversight maintained throughout.

Dr Bonginkosi Shozi, a bioethicist and health law scholar at Stanford Law School, California, told Nature, 'The updated guidelines should be seen as recognising the legal reality in South Africa and providing guidance to health-research ethics committees that is cognisant of that reality.' Dr Shozi previously co-authored a piece in the South African Journal of Science, calling for human germline editing to be 'regulated, not banned.'

However, the new guidelines have been met with concern by some experts. In the Conversation, Professor Françoise Baylis, a bioethicist at Dalhousie University, Canada, and member of the WHO advisory committee on genome editing, wrote that it was 'surprising' that South Africa would facilitate this kind of research as 'Heritable human genome editing has long been hotly contested, in large part because of its societal and eugenic implications.'

Professor Baylis told Nature, 'I know of no other country that explicitly permits this type of research and can't understand why South Africa would want to be the first to do so.'

South Africa has a history of advancing health research while upholding ethical standards, and previous regulations sought to adapt to the rapid progress in genetic science such as CRISPR. While the law in South Africa currently remains unchanged, these latest guidelines could lay the groundwork for potential legal changes to allow heritable human genome editing in the future.