Opening the Door to ‘Designer Babies’? South Africa’s Genome Editing Guidelines Spark Global Debate

South Africa’s updated health-research ethics guidelines, which now include heritable human genome editing, have sparked concern among scientists. The revisions, made in May but only recently gaining attention, outline protocols for modifying genetic material in sperm, eggs, or embryos—changes that could be passed to future generations. This controversial move brings South Africa closer to potentially accepting germline editing, a technique currently prohibited in clinical settings worldwide, though the extent of consultation with the country’s scientific community remains unclear.

South Africa Edges Closer to Approving Controversial Genome Editing, Raising Global Concerns

This recent change in South Africa’s health research ethics guidelines introduces language that could pave the way for heritable genome editing in humans, marking a significant shift in global biomedical policy. Heritable human genome editing, also known as germline editing, involves making genetic modifications to embryos, sperm, or eggs in ways that would be inheritable by future generations. If pursued in clinical settings, this would result in genetically modified children, with potential societal ramifications that have sparked ethical and legal debates worldwide. While many nations have adopted policies against germline editing in humans, South Africa’s updated guidelines suggest it may become the first to explicitly permit such research.

The implications of heritable genome editing extend far beyond medicine, touching on contentious issues around eugenics, human rights, and social inequality. Experts have long cautioned that allowing germline edits in humans could lead to “designer babies,” widening social divides and deepening discrimination based on genetic enhancements. “Heritable human genome editing has long been hotly contested, in large part because of its societal and eugenic implications,” Françoise Baylis, a bioethicist at Dalhousie University in Canada. She expressed alarm at South Africa’s decision, calling it “baffling” and pointing out that “no other country explicitly permits this type of research.” Baylis’s surprise is shared by other experts, as South Africa’s approach appears to counter the global trend toward stringent regulation or prohibition of germline editing.

Concerns Over Lack of Transparency and Public Discourse in Genetic Technology Shifts

Baylis and numerous others who have monitored the landscape of genome-editing policies globally, are particularly concerned about the lack of transparency around this shift. They find it troubling that such a profound change could be made with minimal public discourse or apparent input from the broader scientific community. The scientific community has expressed concerns, particularly regarding the societal impacts of genetic technologies, emphasizing that this shift seems to lack the rigorous ethical debate needed for a matter with such profound implications.

In response to growing concerns, Nature requested comments from South Africa’s Department of Health, which published the revised guidelines, and the National Health Research Ethics Council (NHREC), the statutory body responsible for drafting the updates. However, neither provided a statement before publication. The silence has only heightened concern among scientists who see this development as a step toward a regulatory landscape that may lack the checks and balances necessary for such high-stakes research.

This potential move by South Africa could make it a pivotal case study in how governments approach genetic modifications with far-reaching societal consequences. Scientists and bioethicists alike are now watching closely, noting that South Africa’s decision may either inspire cautious progress or lead to an ethical precedent that could challenge the global norms around human genome editing.

Scientists sound alarm over new ethics guidelines on heritable genome editing. Credit: Tek Image / Science Photo Library

The Risks Outweigh the Rewards: Ethical and Safety Concerns Surrounding Heritable Genome Editing

There is widespread agreement among the global scientific community that heritable genome editing is not acceptable for clinical use at present. While this technology holds the potential to prevent inherited diseases like cystic fibrosis and sickle-cell disease, the associated ethical dilemmas and safety risks make its application highly controversial.

In 2018, He Jiankui, a biophysicist at the Southern University of Science and Technology of China in Shenzhen, claimed to have created the world’s first genome-edited babies. This announcement sparked global outrage, as it violated numerous ethical guidelines and scientific standards. The backlash was swift and severe, leading to his arrest in 2020, where he was sentenced to three years in prison for “illegal medical practice.”

He’s experiment involved editing the embryos of twin girls with the intention of providing them with resistance to HIV. However, many in the scientific and ethical communities quickly pointed out that there were already safer, established medical procedures available to prevent the transmission of HIV, making the rationale behind genome editing medically unconvincing. This raised critical questions about the necessity and justification for editing human embryos, particularly when alternative treatments already exist.

Critical Dilemmas, Unforeseen Consequences, and Lack of Oversight

The ethical concerns regarding He’s actions are manifold. First, the very idea of genetically modifying embryos to create what are often referred to as “designer babies” is deeply troubling to many. This type of editing could potentially alter traits beyond just disease resistance, opening the door to non-therapeutic genetic modifications such as enhancing intelligence or physical appearance. Such interventions could have far-reaching, unforeseen consequences not only for the individuals involved but also for future generations, as changes made to the germline can be inherited by offspring.

Moreover, the lack of public consultation and proper oversight in He’s work further heightened concerns. Ethical guidelines in most countries stress the importance of engaging the public and scientific community in discussions about such profound advancements. However, He’s research proceeded secretly, without the robust ethical debates or transparency that are generally required for such groundbreaking work. This absence of ethical scrutiny and public involvement compounded the outrage, as it suggested a disregard for the social and moral implications of altering human genetics.

Global Moratorium and Call for Stringent Ethical Standards Following He Jiankui’s Controversial Genome Editing Experiment

Following He Jiankui’s announcement, the international scientific community responded swiftly. In 2019, a group of ethicists and researchers issued a call for a global moratorium on the clinical use of heritable human genome editing. This was endorsed by major institutions such as the U.S. National Institutes of Health (NIH). A year later, in 2020, He was arrested and imprisoned for his unauthorized and ethically questionable experiment. When his experiment was revealed, twin girls had already been born, followed by a third child the next year. The long-term effects of the embryonic genome editing on these children remain unknown and are being kept under tight secrecy.

Despite the potential medical benefits of heritable genome editing, such as the elimination of certain genetic disorders, the global consensus remains clear: the risks and ethical concerns far outweigh the potential rewards. The case of He Jiankui’s genome-edited babies has highlighted the need for a cautious and thoroughly regulated approach to human genetic research, ensuring that any advancements in this field are grounded in transparency, ethical integrity, and rigorous scientific oversight.

At the third international summit on human genome editing in 2023, an important statement was made reaffirming that heritable genome editing remains “unacceptable at this time.” This reflected the ongoing global commitment to upholding stringent ethical standards, despite the technological advances that may one day make it possible to edit human embryos for clinical purposes. Until more rigorous ethical and safety frameworks are in place, the international community remains overwhelmingly opposed to the clinical use of this technology.

Debate Over the Legality of Heritable Genome Editing Amid New Guidelines

South Africa’s 2015 health-research guidelines contained only a brief section on genomic research, but the newly updated version includes a comprehensive section on heritable human genome editing. The revised guidelines stipulate that any research in this area must have a clear scientific and medical purpose, particularly focused on preventing severe genetic disorders and improving immunity against serious diseases. Transparency, informed consent, and rigorous ethical oversight are also required, with the potential benefits to individuals and society needing to outweigh the associated risks and uncertainties.

Some experts argue that heritable human genome editing remains illegal in clinical settings, emphasizing that the recent changes to research ethics guidelines do not alter its legal status. Others believe that the law, known as South Africa’s Health Act, already permits this practice, with the updated guidelines aligning with the existing legal framework. While the new guidelines recognize the legal reality, concerns persist that they could be used to push for further legal amendments that would explicitly allow the creation of genetically modified children. As one expert notes, the global community remains hesitant to accept heritable genome editing at this time, raising questions about the implications of these guideline updates.

Illustration of a human embryo at the blastocyst stage, around five to nine days after fertilization. Credit: Juan Gaertner/Science Photo Library

Regulation Rather Than Prohibition: Should We Hold Back From Saving Lives Through Genetic Editing?

The current landscape reflects ongoing debates about the legal and ethical implications of heritable genome editing in South Africa, with some urging caution and others suggesting that regulation, rather than prohibition, is the way forward. Baylis, who also serves on the World Health Organization’s advisory committee for developing global standards on human genome editing, expressed disbelief, saying, “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.”

While heritable genome editing presents potential opportunities for preventing inherited diseases, its current application poses substantial ethical, social, and safety challenges. The case of He Jiankui serves as a stark reminder of the dangers of rushing into groundbreaking scientific advancements without the necessary safeguards, public input, and ethical consideration. Until these concerns are fully addressed, the global scientific community agrees: the risks outweigh the reward

Related posts:

Breaking Ground in Alzheimer’s with 10 Cutting-Edge Treatments Paving the Way in 2024 Novel Triple Immunotherapy Combo Rekindles Hope for Pancreatic Cancer Patients Landmark CRISPR Trial Shows Promise Against Fighting Blindness, but Is It a Cure? Cancer Cells Build Nano-Highways to Hijack Mitochondria from Immune Cells

Author

Bernice Lottering