On 1 March 2019, MEXT revised its "Guidelines on the Handling of Specified Embryos" to allow the birth of offspring by replacing an animal-human chimeric embryo, created by mixing an animal embryo with human iPS or ES cells, into the uterus of an animal. The main objective of this is to produce human organs in animals. These guidelines are based on the Act on Regulation of Human Cloning Techniques, which stipulates the handling of nine kinds of embryos that differ from normal embryos. Thus far, the use of animal-human chimeric embryos had been restricted to "basic research on the production of human embryos for transplantation," but deletion of this restriction has made applications possible.
It has now become certain that a genome promotion law for promoting medical treatment based on genetic data will be submitted during the current Diet session. On 13 March 2019, an all-party Diet members' alliance that had been considering the bill gave discretionary approval of the outline bill to the alliance chairperson. While the bill gives a clear definition of genome treatment and mandates the government to prepare measures for the promotion of research and development, it does not mandate protection against genetic discrimination and contains no clear punishment clauses.
MHWL determines that safety screening for genome edited foods is unnecessary in principle
On 20 March 2019, MHLW held a meeting of the Investigative Panel on Newly-Developed Foods, under the Food Sanitation Subcommittee of the Pharmaceutical Affairs and Food Sanitation Council, at which final deliberations on a report making safety screening for genome edited foods unnecessary in principle were conducted. (See BJ February 2019
) The investigative panel approved the report, making it possible for genome edited food to be distributed for human consumption without safety screening from the summer of this year. In addition to the lack, in principle, of safety screening for genome edited foods, since notifications have also become voluntary, companies will not necessarily give notification of the distribution of such foods. Thus, it will be difficult to find out what these foods are. The Consumer Agency is to consider food labelling at sometime in the future, but as notifications have become voluntary it is impossible to distinguish genome edited foods and there is a great possibility that the implementation of labelling will face difficulties.