Ethics changes notwithstanding, creating genetically modified babies is still illegal in SA

The National Health Research Ethics Council (NHREC) has confirmed that heritable human genome editing (HHGE) remains illegal in South Africa, after changes in the latest version of the South African Ethics in Health Research Guidelines sparked concern among researchers that the country was poised to become the first to explicitly permit the use of genome editing to create genetically modified children.

The guidelines were issued in May, but the new section on HHGE appeared to go largely unnoticed until an article in The Conversation in October — “South Africa amended its research guidelines to allow for heritable human genome editing” — brought it into the spotlight.

In a statement, the chairperson of the NHREC, Professor Penelope Engel-Hills, acknowledged that the wording in the guidelines may have caused some confusion and “unnecessary alarm”, but stated that “reading in” a permissive approach concerning heritable human genome editing was “unconvincing”.

“Firstly, the National Health Research Ethics Council of South Africa (NHREC) wishes to clarify that neither the National Health Act, nor the 2024 National Guidelines on Ethics in Health Research, legalise HHGE for use in therapy in any way.

“The prohibition in the National Health Act makes this position very clear. The ‘reproductive cloning of a human being’ is prohibited in section 57(1) of the National Health Act, punishable as a criminal [offence] by a fine and up to five years’ imprisonment,” said Engel-Hills.

Heritable human genome editing is the editing of nuclear DNA in a way that may be heritable across generations. It differs from somatic human genome editing, where genetic modifications are not passed on to offspring.

In the 2024 South African Ethics in Health Research Guidelines, HHGE research was described as holding “significant potential for addressing genetic diseases and improving human health”, while also presenting “ethical challenges that require careful consideration and deliberation”.

The guidelines provided a framework for approaching heritable human genome editing research, which included:

• Scientific and medical justification;


• Transparency and informed consent;


• Stringent ethical oversight;


• Ongoing ethical evaluation and adaptation;


• Safety and efficacy;


• Long-term monitoring; and


• Legal compliance.

Engel-Hills noted that the guidelines provided a framework for ethical reasoning and decision-making rather than a set of legal rules.

“As the prohibition of HHGE is stated in the National Health Act, the 2024 research ethics guidelines stipulate with regard to HHGE that South African researchers ‘must adhere to all relevant laws governing HHGE research’,” she said.

Heritable human genome editing research would also need to comply with the 2014 Regulations Relating to Research with Human Participants and the 2012 Regulations Relating to the Use of Human Biological Material, she continued.

Crisis of clarity

Françoise Baylis, distinguished research professor at Dalhousie University in Canada, and Katie Hasson, associate director at the Center for Genetics and Society, co-authored the article in The Conversation about the changes to the South African Ethics in Health Research Guidelines.

They noted that in a previously published global survey of policies on heritable human genome editing, they found that more than 70 countries prohibited the practice and no countries explicitly permitted it.

“In a September 2024 presentation that included this research finding, one of us was contradicted by a South African scholar who referred to the May 2024 National Health Research Ethics Guidelines to support his claim that South Africa now explicitly permits heritable human genome editing. We began to research his claim and found no media coverage of the change and little awareness of the new guidelines among policy experts on human genome editing,” stated Baylis and Hasson.

“The statement from the National Health Research Ethics Council of South Africa, clarifying the legal status of human germline and heritable genome editing research, is very helpful. Their authoritative statement aligns with our understanding that the legal prohibition on human reproductive cloning ‘imports a prohibition on heritable human genome editing’.”

Subject of controversy

Heritable human genome editing has long been controversial in scientific circles. In a case that made global headlines, Chinese scientist He Jiankui was sentenced to three years’ imprisonment in 2019 for violating medical regulations after he claimed to have used a gene-editing procedure known as CRISPR-Cas9 to genetically modify twin sisters before birth, in an effort to make the children immune to HIV.

Earlier this year, The Guardian reported that He had resumed his research on human embryo genome editing and continued to defend his work, despite the alleged ethical breaches it involved.

One of the commonly cited concerns when it comes to heritable human genome editing is that the process could have unintended, off-target effects and that these could be passed down to subsequent generations.

Another argument, mentioned in Baylis and Hasson’s article, is that there is little justification for the process, given that other safe reproductive procedures to avoid transmitting genetic diseases are already in widespread use.

Baylis told Daily Maverick she thought it was premature to discuss the legalisation of heritable human genome editing.

“Whether we should pursue this technology remains an open question. My own work suggests that as yet, there is no good argument in support of this. At a minimum, we need ongoing international dialogue,” she said.

“To be clear, I support somatic genome editing (where genetic modifications are not passed on to offspring) and this is where we need very clear research ethics guidelines. There have been successful clinical trials involving somatic genome editing for sickle cell disease and therapies have been approved in the US and the UK. I (and many others) have serious concerns about the cost of these therapies (in the millions) as this will seriously limit access to those who need this most.”

Dr Susan Hall, the head of the Unit for Bioethics at Stellenbosch University, said that genetic modification was a tool with the potential to achieve great things, such as the eradication of certain diseases. She also cautioned against the “slippery slope” argument that the legalisation of heritable human genome editing would result in designer babies — babies whose genetic makeup had been selected.

“We cannot assume that opening the door for gene editing for clinical purposes, for the purposes of treating disease, is going to lead to creating designer babies… The other thing that I think we should be cautious of is what we call the ‘yuck factor’ — that … we feel a bit gross and uneasy about genetic modification. That is not necessarily an argument against genetic modification … although we should, of course, be very cautious about risk,” she said.

Hall noted that if South Africa were to become one of the first countries to legalise heritable human genome editing, she would be concerned about the potential for “helicopter research”, which is when researchers come into the country from elsewhere, do their research and leave without involving local researchers in a meaningful way. DM