Embryo research rules under review
The Japanese government plans to revise its basic policy on conducting research on human embryos, in an effort to implement state-led regulations on such research, The Yomiuri Shimbun has learned.
Aiming to meet the challenges posed by new technologies such as genome editing — a technology that efficiently alters genes — the government is considering limiting human embryo modification through genome editing to basic research, and prohibiting both the implantation of embryos with altered genes in a uterus and the live births of such embryos.
Concrete discussions will start in a new organization expected to be established under the Council for Science, Technology and Innovation, chaired by Prime Minister Shinzo Abe.
The government will make a decision on the establishment as early as this month.
Compiled in 2004, the current basic policy on research using human embryos states that any handling of embryos that causes damage to them is not permitted. However, there is no specific provision for genome editing — an area in which research has intensified since the policy’s release — or for nuclear transfer, a treatment that implants the genetic material from an egg or embryo into another healthy egg or embryo.
While expected to be useful for treating genetic diseases and infertility, genome editing is giving rise to concern that it could lead to births of “designer babies,” supposedly ideal offspring created just as their parents wish. Basic research on genome editing in Britain and China, which have already set relevant rules, is ahead of such research in Japan.
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Nuclear transfer is also raising ethical issues as a baby inherits genetic information from the woman who provides the egg in addition to that of his or her own parents. This treatment was legalized in Britain in 2015 and was first carried out in Mexico by a U.S.-based clinic. The Japanese government, however, only plans to give cautious consideration to the treatment.
The revision of the basic policy aims to prepare an environment for Japan’s human embryo research, which tends to lag behind other countries. Even so, there is still room for clinical applications in private hospitals as the government does not intend to enforce legal provisions to regulate such research.
The Health, Labor and Welfare Ministry has begun to consider banning clinical research that aims for live births from embryos whose abnormal genes were repaired through genome editing, by applying the government’s guideline on such research.
And yet, academic associations such as the Japan Society of Human Genetics have urged the government to consider implementing regulations on all relevant research, including infertility treatment. This has led the government to plan to revise the basic policy, which takes precedence over the guideline.
Sometimes likened to editing a sentence, genome editing technology is used to alter a cell’s genetic information at will. A combination of enzymes — which play the role of “scissors” to cut the chains of genes — and other molecules, which accurately lead the “scissors” to the right spots for cutting, make it possible to remove the targeted genes or to replace them with others. Through genome editing, progress has been made on the treatment of intractable diseases such as muscular dystrophy as well as in research aiming to develop highly resistant crop varieties.