Japan takes action as human genome-editing runs out of control

Japan, a world leader in genome research, has begun legal measures to regulate the medical application of genome editing technology. Last week, a policy was approved by a working committee of the Council for Science, Technology and Innovation of the Cabinet Office.
Envisaged rules include a ban on modification of genes in human fertilised eggs and on implanting genetically modified cells in the uterus for the purpose of childbearing.
The study of regulatory measures has been spurred by the birth of a genome-edited baby that was confirmed in China. The Chinese authorities, despite having set guidelines to regulate the manipulation of the basic materials of life, could not stop a researcher from running out of control.
Japan too has so far planned to deal with such life manipulation based on guidelines rather than establishing any specific legislative measures. This is based on the judgement that the ways new technologies are utilised change more quickly than the law governing them.
Japan’s government has shifted to a policy of imposing legal regulations, possibly because genome editing has progressed faster than it anticipated.
A matter of concern is the ease with which genome editing can be done. Genes can be modified by merely adding a reagent to cultured cells. In the Chinese case, genome editing was performed on fertilised eggs.
There may be other researchers who will try to do the same things as done by the Chinese researcher. There has been a chorus of opinions at the working group of the Council for Science, Technology and Innovation that “enforceable legal restrictions should be urgently implemented.”
Strict screening crucial
Genome editing makes it possible to modify targeted genes with a high degree of accuracy, but there will also be errors. It is possible that modification of genetic sequences will cause serious adverse effects. A genome-edited baby may have a risk of developing unexpected diseases, with the risk passed on to the baby’s future offspring.
Also of concern is abuse of genome editing technology for the creation of “designer babies” whose genes have been selected by genetic engineering.
The World Health Organisation has set up an advisory committee to study measures for dealing with human genome editing. In its initial meeting last month, the panel proposed introducing a registration system for research on human genome editing.
The government is called on to promote discussions on genome editing while giving due consideration to such international regulatory moves.
In parallel with legal regulations, the government will study measures to promote fundamental research using genome editing in line with bioethics. This is aimed at helping to elucidate the mechanisms of congenital and other diseases. The Japan Medical Association hopes that genome editing technology will contribute to identifying causes of intractable diseases and developing cures.
In both of those cases, editing is done on sperm or egg cells, or fertilised eggs, but the altered cells are not implanted in the uterus. Since genome editing involves manipulation at the very beginning of life, it is imperative to conduct strict screening of individual cases from ethical viewpoints.
In Japan, medical treatment comes under the jurisdiction of the Health, Labour and Welfare Ministry while research is under that of the Education, Culture, Sports, Science and Technology Ministry. The two ministries are called on to cooperate closely with a view to striking a balance between regulation and research.