Will South Africa become first country to accept controversial form of human genome editing?

Researchers have voiced concerns after South Africa updated its health-research ethics guidelines to include a new section on heritable (or germline) human genome editing.

Scientists say this could put the nation one step closer to accepting the controversial technique — which involves introducing genetic changes to sperm, eggs or embryos, such that the modifications will be passed down through successive generations. The research ethics guidelines were updated in May, but the news became more widely known last month.

Currently, no country explicitly allows heritable human genome editing in clinical settings. It is not clear to what extent South Africa’s scientific community was consulted on the changes.

Nature has requested comment from South Africa’s department of health, which published the revised guidelines, and from the National Health Research Ethics Council, a statutory body under the National Health Act, which drafted them. No comment was received by the time this article was published.

“The decision to amend the South African Ethics in Health Research Guidelines to facilitate research to create genetically modified children is baffling,” says Françoise Baylis, a bioethicist at Dalhousie University in Halifax, Canada who wrote about the change in an article in The Conversation.

“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,” adds Baylis, who is also a member of the World Health Organization’s advisory committee on developing global standards for governance and oversight of human genome editing.

There is an international consensus among researchers that the practice is not acceptable in the clinical setting. Such editing could prevent inherited diseases, such as cystic fibrosis and sickle-cell disease, but it poses significant ethical concerns and safety challenges.

In 2018, He Jiankui, a biophysicist then at the Southern University of Science and Technology of China in Shenzhen, claimed to have helped make the world’s first genome-edited babies. That caused a global outcry. He was jailed in 2020 for “illegal medical practice”.

In 2019, an international group of ethicists and researchers called for a moratorium on the clinical use of heritable human genome editing, which was supported by the US National Institutes of Health. The organizing committee of the third international summit on human genome editing said in 2023 that heritable human genome editing “remains unacceptable at this time”.

Before and after

South Africa’s previous guidelines from 2015 had a relatively small section on genomic research. In the latest version, a new section on heritable human genome editing has been added.

The updated text says that heritable human genome editing must have a “clear and compelling scientific and medical rationale, focusing on the prevention of serious genetic disorders and immunity against serious diseases”, be transparent, obtain informed consent from all parties and have stringent ethical oversight. “The potential benefits to individuals and society should outweigh risks and uncertainties,” the guidelines say.

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Furthermore, researchers must “commit to ongoing monitoring of individuals born as a result of [heritable human genome editing] to assess their health, well-being and potential unforeseen consequences”.

The guidelines note that researchers must adhere to all relevant laws governing such research. However, there are different views on whether South Africa’s law, the National Health Act actually allows for heritable human genome editing.

Is it even legal?

Jantina De Vries, director of the EthicsLab at the University of Cape Town, is among those who says that heritable human genome editing is illegal in clinical settings. She cautions against reading too much into the amended guidelines. “What has changed is the research ethics guidelines, not the legality of heritable human genome editing in any other sense beyond research,” she says.

By contrast, Bonginkosi Shozi, a bioethicist and health-law scholar at Stanford Law School’s Center for Law and the Biosciences in California, takes the view that the law already allows heritable human genome editing, and that the revised research ethics guidelines have now caught up with the law.

In a 2020 study in the South African Journal of Science¹, Shozi and four co-authors wrote: “Given its potential to improve the lives of the people of South Africa, human germline editing should be regulated, not banned.”

Shozi told Nature: “The [updated] guidelines should be seen as recognizing the legal reality in South Africa and providing guidance to health-research ethics committees that is cognizant of that reality,” he says.

Baylis says that she is concerned that advocates of heritable genome editing might use the new guidelines to push for further legal amendments that will explicitly permit the creation of genetically modified children.

“Globally, there is a reluctance to accept heritable genome editing at this point in time,” says Michael Pepper, director of the Institute for Cellular and Molecular Medicine at the University of Pretoria. “We need to examine in more detail why our guidelines have been published in the way that they have.”