A subtle yet significant amendment to South Africa’s national health research guidelines, made public in May, has placed the country at a pivotal point between ethics and scientific advancement. With this new approach, South Africa may become the first nation to openly support genome editing for creating genetically modified children, potentially opening a new chapter in genetic modification.
Heritable human genome editing has long been a controversial issue, primarily due to its societal implications and the potential risks of eugenics. Observers in the global policy landscape, including academic Françoise Baylis and public interest advocate Katie Hasson, have noted the surprising decision by South Africa to facilitate this type of research. This move raises numerous ethical questions and concerns about the future of genetic equity, the potential for discrimination, and the societal impacts of altering human genetics.
The controversy surrounding heritable human genome editing was reignited in November 2018, when media outlets reported that a Chinese scientist had created the world’s first gene-edited babies using CRISPR technology. His aim was to confer resistance to HIV, the virus responsible for AIDS. By the time his experiment was revealed, twin girls had already been born, with a third child following a year later. The long-term health outcomes for these children, and whether they suffered any adverse effects from the embryonic genome editing, remain shrouded in secrecy.
The Outcry and Backlash
The announcement of gene-edited babies triggered considerable backlash, with critics raising serious ethical concerns about altering the genetics of future generations. They argued that modifying embryos should be strictly limited, as it opens up complex questions about the natural inheritance of traits. Many also pointed out that the reasoning behind the gene-editing was weak, as safe and effective reproductive methods already exist to prevent genetic diseases. This made the justification for such an extreme approach appear unnecessary and flawed. Additionally, the scientist’s secretive methods and failure to engage the public in discussions were viewed as ethically troubling, given the societal importance of such research and the potential long-term impact on humanity. Public involvement and transparency are widely seen as essential steps in pursuing any scientific path with far-reaching consequences
After the 2018 revelation of gene-edited babies, the organizing committee of the Second International Summit on Human Genome Editing quickly joined the global outcry, condemning the research. Nevertheless, the committee also called for a “responsible translational pathway” for clinical research, asserting that safety thresholds and criteria like independent oversight, clear medical necessity, and long-term monitoring must be met before moving forward. Noticeably, the new guidelines omitted the previous requirement for a “broad societal consensus,” raising concerns about the lack of public input in decisions that may alter future generations.
New Guidelines in South Africa
Fast forward to the present, and South Africa's newly amended Ethics in Health Research Guidelines now explicitly consider research that could lead to the birth of gene-edited babies. In Section 4.3.2, titled “Heritable Human Genome Editing,” the guidelines outline several important criteria that must be met. These include scientific and medical justification, the necessity of transparency and informed consent, stringent ethical oversight, ongoing ethical evaluation, safety and efficacy assessments, long-term monitoring of outcomes, and adherence to legal compliance. While these criteria reflect some of the standards established at the 2018 summit, they are notably less stringent compared to the frameworks developed in subsequent reports, such as the World Health Organization’s "Human Genome Editing: Framework for Governance," which was co-authored by Françoise Baylis. This shift raises concerns about the adequacy of protections for future generations as the potential for gene editing in humans becomes more feasible.
The Legal Landscape
However, there lies a significant disconnect within South Africa’s regulatory framework regarding heritable human genome editing. While the guidelines mandate compliance with existing laws governing genetic research, a legislative barrier complicates this landscape. The South African National Health Act of 2004 explicitly prohibits reproductive cloning and any manipulation of genetic material for that purpose, including that of human gametes, zygotes, or embryos. When this law was enacted, the technology to genetically modify human embryos had yet to be developed, which is why it lacks explicit mention. However, its broad language is sufficient to encompass heritable genome editing, implying a prohibition on such practices.
Ethical Dilemmas
A pressing concern is why South Africa's ethical guidelines appear to be advancing the agenda for heritable human genome editing. In 2020, we, along with our colleagues, conducted a global review of policies surrounding this technology. At that time, we identified over 70 countries with policy documents prohibiting heritable genome editing, without any that explicitly allowed it.
There may be justifiable reasons for South Africa’s ethicists to facilitate somatic human genome editing research, especially following the development of an effective treatment for sickle cell disease through genome editing technology. This disease claims many young lives, and somatic genome editing—unlike heritable editing—does not involve altering embryos, offering a potential cure.
Questions for the Future
However, the question remains unanswered that what drives the interest in advancing research on heritable human genome editing, , a technology that will affect generations to come? Why was the guideline change made so discreetly? How many South Africans are aware that their country now stands alone in having research guidelines that allow for such a debated technology? And have the wide-ranging risks tied to CRISPR, from impacts on women and prospective parents to broader societal and genetic consequences, been fully examined?
Moreover, could it be that scientists from abroad are waiting in the wings to exploit South Africa's permissive stance? If the research guidelines are adapted to align with the 2004 law, would this result in a wave of scientific tourism, with laboratories relocating to South Africa to take advantage of more accommodating research policies?
We hope that our inquiries may sound alarmist, but now is the time to engage with these questions critically and thoughtfully. The implications of these guidelines stretch far beyond South Africa, setting a precedent that could influence global discourse on the ethics and governance of heritable human genome editing.
