Report on the Regulation of Genome Editing in Japan

In Japan, biomedical researches are regulated by several statutes and several administrative guidelines. As to the regulation of embryo research, the Act on Regulation of Human Cloning Techniques regulates researches on cloned human embryos and certain embryos with both human and animal genetic elements. There are also several guidelines regulating specific area of research such as genome analysis, gene therapy clinical research, ES-cell research, and so on. However, there was no statute or guideline that regulates genomic improvement of embryos or germ-line cells in general. So, active discussions on the regulation of genome editing occurred in 2016, and temporarily the Expert Panel on Bioethics (EPB) and its subpart (“Task Force”) decided a policy to allow only one type of research using embryos genetically modified by genome-editing technology. The discussion on regulation system has been so confused, and that is probably a reflection of the cultural background of Japanese politics and the law.