In May 2024, South Africa amended its national health research guidelines to include provisions for heritable human genome editing. This controversial development has placed the country at the center of a global ethical debate.
This amendment permits the use of genome editing technology, such as CRISPR, to genetically modify human embryos, positioning South Africa as the first country to allow this kind of research explicitly.
Heritable human genome editing has been widely contested due to its societal and eugenic implications raising concerns about the potential long-term consequences of altering human genetics, particularly across generations.
The controversy surrounding genome editing for reproductive purposes intensified in 2018 when a Chinese scientist claimed to have created the world’s first gene-edited babies using CRISPR technology. The scientist’s stated goal was to provide resistance to HIV in the embryos. However, his work was met with widespread condemnation for its secrecy, lack of public consultation, and unconvincing medical rationale, as safer reproductive procedures already existed to avoid passing on genetic conditions. The backlash led to the formulation of more stringent criteria for research involving genome editing, calling for safety thresholds, independent oversight, and long-term monitoring.
Despite the global criticisms, South Africa’s amended guidelines now include criteria for heritable genome editing research, such as scientific justification, informed consent, stringent ethical oversight, safety, efficacy, and long-term monitoring.
These criteria are generally in line with those proposed by international organizations such as the World Health Organization, but they are less stringent than other global frameworks. Additionally, the guidelines require that research comply with South African law, but this is complicated by existing legislation in the National Health Act of 2004, which prohibits reproductive cloning and manipulation of human genetic material for reproductive purposes. This creates a conflict between the updated guidelines and the current law, which has not yet addressed the legal implications of genome editing.
The amendment to South Africa’s ethical guidelines reflects a shift in the country’s stance on gene editing research. While the guidelines align with some international principles, they do not fully comply with the current legal framework.
This discrepancy raises questions about the potential for future research in this area and the broader implications of such developments. However, there has been no indication of immediate changes to the law, leaving the future of heritable human genome editing in South Africa uncertain.