Industry groups call for 10-year halt on heritable human genome editing

Three cell and gene therapy industry groups — the International Society for Cell & Gene Therapy (ISCT), the Alliance for Regenerative Medicine (ARM), and the American Society of Gene & Cell Therapy (ASGCT) — have released a joint statement calling for a 10-year international moratorium on heritable human genome editing (HHGE).

The groups are calling for the moratorium on the basis that HHGE’s “scientific underpinning is currently insufficient to demonstrate its safety, that its potential use cases are few with safer alternatives in development, and that its ethical permissibility has not been established through broad societal consensus.”

Leaders from scientific, biotech, patient, religious, bioethics and policy communities convened in Washington, DC in March, reaffirming the urgent need for responsible oversight and governance of genetic technologies with the potential to alter the human germline. Specifically, they looked to create a distinction between somatic cell gene editing (SCGE) and HHGE and ensure a responsible approach to genetic advancements.

SCGE involves modifying a patient’s DNA within the body’s non-reproductive cells to treat or cure diseases including those caused by genetic mutations. In contrast, HHGE involves making changes to the genetic material of eggs, sperm or cells of early embryos, potentially ‘programing’ traits deemed desirable and eradicate undesired ones.

According to the joint statement from ISCT, ASGCT and ARM, “Rogue actors – including fame- and fortune-seekers – remain the greatest risk to applying HHGE before ethical and safety concerns are fully addressed.”

In December 2019, Chinese researcher He Jiankui — who had revealed the year prior that he had helped produce genetically edited babies — was found guilty of conducting "illegal medical practices" and sentenced to three years in prison. Now out of prison, it has recently been reported that Jiankui is back in the lab and plans to continue his human experiments. “Ethics is holding back scientific innovation and progress,” claimed Jiankui on Twitter.

Extending the moratorium on HHGE until 2035 will give the international community time to further reflect upon needed scientific, ethical, and regulatory safeguards, according to the recently shared joint statement.

“The scientific community has demonstrated the potential of SCGE to revolutionize medicine without the ethical and safety risks associated with HHGE. Unless comprehensive global governance, medical necessity, extensive safety research, and broad ethical consensus are achieved, HHGE must remain off-limits,” concluded the statement.