South Africa's controversial guidelines on heritable human genome editing
In a bold and somewhat controversial move, South Africa has updated its health-research ethics guidelines to include a new section on heritable human genome editing.
This scientific technique involves modifying the genetic material of sperm, eggs or embryos, ensuring that the changes are passed down to future generations.
Although the guidelines were amended in May 2023, the update has only recently gained widespread attention, raising significant concerns among researchers and bioethicists alike.
What is heritable human genome editing?
Heritable human genome editing refers to the process of altering the DNA of reproductive cells - sperm, eggs or embryos - so that the genetic changes are inherited by future offspring.
This technology has the potential to prevent serious genetically inherited diseases, such as cystic fibrosis and sickle-cell disease, by correcting the faulty genes that cause these conditions.
However, the implications of this technique go far beyond the possibility of preventing disease.
The idea of altering the human genome raises profound ethical, social and safety concerns, which have led to a global consensus against its use in clinical settings.
A global consensus against the editing of heritable genomes
According to Nature, to date, no country explicitly allows heritable genome editing in clinical practice. Many nations have regulations that prohibit such research due to the ethical and safety risks involved.
For instance, in 2019, a group of international researchers and ethicists called for a global moratorium on heritable genome editing.
This call was supported by influential organisations such as the US National Institutes of Health.
The overwhelming view among the scientific community is that the clinical application of this technology is not sufficiently safe and raises moral questions about the future of genetic modification in humans.
A stark example of the potential dangers of this technology came in 2018, when He Jiankui, a Chinese biophysicist, claimed to have created the world's first genome-edited babies.
His research, which involved altering the genome of embryos to make them resistant to HIV, led to global outrage. He was sentenced to prison for “illegal medical practice” in 2020.
This incident highlighted the potential misuse of genome editing technology and the need for strict legal and ethical guidelines.
South Africa's new guidelines
South Africa’s recent update to its health-research ethics guidelines has sparked concerns that the country may be inching closer to accepting heritable genome editing.
The revised guidelines now include a section on this controversial technology, which outlines the conditions under which it may be permissible for research purposes.
According to the updated text, heritable 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.
Additionally, the guidelines stress the importance of transparency, informed consent, and ongoing monitoring of individuals born as a result of such research.
While these updates may seem like a step toward responsibly regulating heritable genome editing, many experts are alarmed by the implications.
Françoise Baylis, a bioethicist at Dalhousie University in Canada, expressed her concerns in an article for “The Conversation”.
She finds it “baffling” that South Africa would want to be the first country to explicitly permit this type of research, given the global consensus against it.
“I know of no other country that explicitly permits this type of research,” Baylis said, adding that the decision could pave the way for further legal amendments that might allow the creation of genetically modified children.
Is it even legal?
The legal status of heritable genome editing in South Africa remains unclear. Some experts argue that the updated guidelines do not necessarily indicate a shift in legal policy.
Jantina De Vries, director of the EthicsLab at the University of Cape Town, cautions against over-interpreting the amendments.
She emphasises that the revised guidelines pertain to research ethics, not to the legality of heritable genome editing in clinical settings. According to De Vries, heritable genome editing remains illegal under South Africa’s National Health Act.
However, others believe the legal landscape may be more permissive. Bonginkosi Shozi, a bioethicist and health-law scholar at Stanford Law School, holds a different view.
Shozi argues that the law already allows heritable genome editing in certain contexts and that the updated guidelines simply reflect this legal reality.
In a 2020 study published in the South African Journal of Science, Shozi and his co-authors advocated for a regulated approach to heritable genome editing, citing its potential to improve lives by preventing genetic disorders.
Ethical and social implications
The ethical debate surrounding heritable human genome editing is complex. On one hand, the technology could offer life-saving treatments for people with genetic disorders.
On the other hand, it raises concerns about “designer babies”, where genetic traits such as intelligence or physical appearance could one day be selected or enhanced, potentially leading to societal inequalities.
Moreover, the long-term risks of editing the human genome are largely unknown. While the intention may be to eliminate genetic diseases, the possibility of unintended consequences—such as new genetic disorders or unforeseen health issues in future generations—cannot be ruled out.
Michael Pepper, director of the Institute for Cellular and Molecular Medicine at the University of Pretoria, points out that there is a global reluctance to accept heritable genome editing at this time.
He calls for further examination of why these guidelines have been updated in South Africa and what implications they may have for the future of genetic research in the country.
South Africa’s updated guidelines on heritable human genome editing have ignited a global discussion about the ethical, legal, and social implications of this powerful technology.
While the potential benefits of preventing genetic diseases are undeniable, the risks and ethical concerns surrounding the modification of the human genome must be carefully considered.
As the global scientific community continues to voice its concerns, South Africa finds itself at the forefront of a debate that could reshape the future of genomic medicine.
The question remains: Is society ready for this level of genetic intervention, and, if so, at what cost?