Singapore’s bioethics advisory committee urges caution on heritable gene editing

SINGAPORE – Recent advancements in gene-editing technologies have made it easier to modify a person’s DNA, offering hope for treating serious inherited conditions or diseases like cancer.

But complex ethical issues are raised.

Among these technologies, heritable gene editing is the most controversial because it could change the genetic make-up of future generations.

It can be used to confer resistance to diseases or treat infertility, but can also ensure a baby will not inherit a fatal disease.

And scientists could potentially engineer the baby to have desired traits – such as higher intelligence – should that be permitted in the future.

Singapore’s Bioethics Advisory Committee (BAC) has concluded in a newly released report that heritable gene editing is not recommended for clinical research or application in Singapore.

The report, released on Oct 23, cited the unknown long-term effects and the need for full validation of the technology’s safety and efficacy.

For instance, unintended edits introduced during genetic modifications may be passed down to future generations, it said.

The Ministry of Health (MOH) has also not approved heritable gene editing as there is currently insufficient evidence of its safety.

BAC’s recommendation was included in an advisory publication on the ethical use of Human Nuclear Genome Editing (HNGE) technologies in biomedical research and clinical applications.

The advisory titled

Ethical, Legal And Social Issues Arising From Human Nuclear Genome Editing

was launched during the inaugural Asian Bioethics Network (ABN) Conference.

The conference was jointly held by BAC and the Centre for Biomedical Ethics (CBmE) at the NUS Yong Loo Lin School of Medicine on Oct 23 and 24.

HNGE technology is not just used in heritable gene editing, but also in non-heritable gene editing and gene editing in embryos or germline cells – the cells from which eggs in females and sperm in males are derived.

Non-heritable gene editing – gene editing in cells in the body which cannot be passed down to future generations – is used in research to understand diseases and cancer development or for diagnostics and drug discovery tools. In the clinical context, it is used to correct disease-causing mutations.

Non-heritable gene editing is regulated in Singapore.

Research involving gene editing in germline cells or embryos is done to advance scientific research and understanding of human embryos, without gestation. This is strictly regulated here.

To use HNGE safely and ethically, researchers must follow clear protocols, obtain informed consent and monitor long-term outcomes, BAC said.

BAC was established by the Singapore Cabinet in 2000 as an independent national advisory body to examine and develop policy recommendations on the ethical, legal and social issues arising from human biomedical science and research.

In Singapore, three gene therapies have been approved by the Health Sciences Authority, including one for spinal muscular atrophy.

The scientific techniques that allow researchers and clinicians to modify one’s DNA by adding, removing or changing genetic material include the ground-breaking Crispr-Cas9 tool.

Chinese scientist He Jiankui shocked the world in 2018 when he revealed that he had used the tool to engineer the birth of the world’s first babies with edited genomes to make their cells resistant to infection by the human immunodeficiency virus (HIV).

At the ABN conference’s opening ceremony, Professor Kenneth Mak, Singapore’s director-general of health, highlighted the rapid advances in biotechnology and biomedical sciences and the accompanying ethical concerns.

He emphasised how developments such as artificial intelligence (AI), precision medicine, gene editing, and innovations that advance human longevity, are bringing us closer to what was once unimaginable – cures for hereditary diseases and extended healthy lifespans.

“Precision medicine promises accelerated diagnoses and targeted prevention but also challenges us to manage data disclosure and confidentiality,” he explained.

“Healthcare providers must navigate whether, when, and how to disclose genetic information, especially when variants of uncertain significance may only gain clinical meaning in the future.”

Singapore must adapt approaches to keep pace with evolving technologies, such as the rapidly evolving field of human gene editing, he added.

Using the 2018 case of Crispr-modified babies in China as a warning about the risks of applying such technologies without adequate safeguards, he said that while the field has the potential to eliminate disease, a lack of due consideration for ethics can result in harm.

The attempt to reduce susceptibility to HIV had instead violated established safety norms and introduced a harmful mutation, underscoring the need for responsible governance to protect patients and sustain public trust, said Prof Mak.

The conference, held at the Grand Copthorne Waterfront Hotel Singapore, explored some of the most pressing ethical questions confronting modern healthcare, especially those that surround the use of AI.

Associate Professor Brian D. Earp, director of the Oxford-NUS Centre for Neuroethics and Society within CBmE, spoke about patients having a digital psychological twin – a model trained on the values and preferences of the patient. 

The question arises: Can such a model understand the patient well enough to make medical decisions on his or her behalf, when the patient is, for instance, in a coma?

Keynote speaker Professor Glenn Cohen, deputy dean and faculty director of the Petrie-Flom Centre for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, said that even training an AI system to schedule appointments can raise considerable ethical concerns.

“How many patients should you schedule in a day? How much overlap should there be?”

The issue arises when attempting to train an AI system to predict whether a patient will be late or fail to show up. This could lead to scenarios where those without reliable transport or those heavily affected by serious illnesses receive the least amount of attention from the physician, he explained.

In his keynote session, Professor Julian Savulescu, Chen Su Lan Centennial Professor in Medical Ethics and head of CBmE, spoke about how to form ethical policy, giving examples that included which patient to prioritise during a pandemic when there is a ventilator shortage.

At the conference, BAC also released a second publication – a casebook titled Biomedical Ethics In Singapore: Cases And Commentary.

It consolidates important court rulings related to medico-legal issues, offering healthcare professionals, policymakers and the public a comprehensive reference on how legal principles intersect with medical practice.