A Japanese government expert panel agreed Thursday to legally ban and penalize research or medical practices that genetically modify human embryos to implant into humans or animals for the purpose of producing babies.
The policy discussed by a joint panel of the health and science ministries and the Children and Families Agency aims to legally restrict the birth of gene-edited babies. The government plans to submit a relevant bill to the ordinary Diet session in 2026.
While current guidelines prohibit research that involves returning a gene-edited embryo to a human uterus, violations carry no penalties. Concerns have been raised about attempts to create "designer babies," where people select preferred traits such as height or intelligence.
Many countries in Europe have already established regulations enforceable by law.
The joint panel noted that, as current knowledge on the clinical application of gene-edited embryos remains limited, it is impossible to properly assess technical limitations and risks.
Citing fears that unexpected genetic functions could arise and be passed on to future generations, it concluded that "legal regulation is necessary" to ensure effectiveness of the guidelines.
The government is considering criminal penalties of up to 10 years' imprisonment or a fine of up to 10 million yen ($64,000) for those who implant gene-edited embryos into the uterus of a human or animal.
Under guidelines to be formulated, research involving gene-edited embryos will require notification to the government and mandatory record-keeping. Genetic modification of sperm or eggs, as well as the use of conventional genetic recombination technologies, will also be subject to regulation.
But the panel also stressed the need to ensure that legal regulation does not hinder the advancement of basic research, emphasizing the importance of continuing discussions with the possibility of permitting clinical applications in the future.
In 2018, a Chinese researcher announced a set of twins had been born with edited genomes, sparking international debate over the ethics of the procedure. A panel of Japan's Cabinet Office proposed the following year that relevant ministries consider introducing legislation on the controversial technology.