No Genome-Edited Babies for Japan: Health Ministry to Submit Bill Banning Implantation of Edited Zygotes

Yomiuri Shimbun file photo
The Health, Labor and Welfare Ministry in Tokyo

A regulatory proposal prohibiting the implantation of fertilized human eggs that have been modified with genome editing technology into human or animal wombs was finalized on Thursday by a joint meeting of specialized committees from the Health, Labor and Welfare Ministry and the Education, Culture, Sports, Science and Technology Ministry.

Genome editing technology targets certain genes and efficiently alters them.

Penalties for violations will also be established. The goal is to submit a bill as early as next year during the ordinary Diet session.

In 2018, the birth of genome-edited babies from genome-edited fertilized eggs was publicly announced in China, drawing global condemnation. Japan established guidelines in 2019 that permitted research on genome-edited fertilized eggs for basic research purposes only and prohibited research involving their implantation into human or animal wombs.

According to the proposed regulations, research involving the implantation of genome-edited human fertilized eggs into wombs will be prohibited by law. Researchers must submit a plan detailing creation method, quantity and research content to the government in advance for research involving the creation or use of genome-edited human fertilized eggs. The government can order the suspension or modification of the plan as necessary.

Detailed guidelines incorporating specific regulatory content will be formulated to define aspects such as plan requirements. Furthermore, the possibility of permitting future clinical use will be continuously reviewed.

Research using genome editing technology on fertilized eggs is expected to shed light on the causes of such conditions as infertility and congenital disorders. However, there are strong concerns regarding the technology to create genome-edited babies in wombs. Countries in Europe and the United States have established legal regulations with penalties.

Meanwhile, in recent years, some overseas start-ups have been attempting to treat congenital disorders in fertilized eggs and create genome-edited babies.

The joint meeting concluded with an agreement on a policy to strengthen regulations in Japan, because current technological standards cannot sufficiently confirm the safety and risks in the next-generation and beyond.

In 2021, a World Health Organization (WHO) advisory committee published a report recommending a prohibition on the clinical use of genome editing technology on fertilized human eggs.