Japan’s germline gene editing regulations are looser than in most of the world, but still restricted. Draft guidelines issued in 2018 allow for gene editing of human embryos for research to treat genetic diseases. The guidelines restrict germline gene editing for reproductive purposes and clinical testing but violations are not punishable by law. The guidelines also do not regulate doctors at private hospitals who might use gene editing for treatment; they only regulate researchers.
The Ministry of Education, Culture, Sports, Science and Technology is responsible for regulating germline gene editing. Research requires approval from the ministry and from an ethics panel at the institution or university conducting the research.
After a Chinese scientist altered the DNA of human embryos that were carried to term, many scientists in Japan and around the world argued that germline gene editing should not be used for reproductive purposes, at least until more research is done. Japan’s updated germline gene regulations followed this outcry.
In a world first, in 2018, Kyoto University announced that it would start providing embryonic stem cells to universities and companies for clinical trials. The university uses fertilized eggs left over from fertility treatments. Most countries have been hesitant to produce and distribute embryonic stem cells as their use in research has been highly controversial.
In 2019, the Ministry of Education, Culture, Sports, Science and Technology, reversing an earlier ban, allowed scientists to create animal embryos that contain human cells (aka human-animal chimeras), and subsequently transplant them into surrogate animals. This research may lead to the development of human-compatible organs. The revised guidelines don’t allow fertilization of human-animal chimeras with human eggs or sperm.
Products/Research
- Human organs in animals: University of Tokyo received approval to grow human organs in rat and mice embryos (aka human-animal chimeras). The research is in its early stages; the goal is to develop human-like pancreases that can be transplanted into humans.
Regulatory Timeline
2019: Japanese science ministry allows scientists to grow human-animal chimeras (human cells in an animal embryo that are transferred to an animal’s uterus), reversing an earlier ban on the practice. The goal is to use animals to grow organs that can be transplanted into humans.
2018: Kyoto University announces it will start providing embryonic stem cells to universities and companies for clinical trials.
2018: Draft guidelines issued that allow for gene editing research in human embryos. Gene editing embryos for reproductive purposes is not allowed, but is not punishable by law.
2014: Japanese government revises guidelines, making possible the use of human embryonic stem cells in clinical studies as well as laboratory research.
NGO Reaction
Some researchers and bioethicists have raised concerns about Japan’s relaxed guidelines on human-animal chimeras that allow for human cells in animal brains as well as embryos made from both human and primate cells—much more so than if they were only present in heart, blood, or liver tissue. Their concerns echo surveys of the Japanese public that suggest worries that animals could become humanized and that the boundary between humans and animals could become blurred. However, scientists familiar with the research say the chimeras being developed in Japan, if brought to term, would not take on human-like behavior, although the animals might not behave like “normal” rodents.
The International Society for Stem Cell Research (ISSCR) Guidelines for Stem Cell Research and Clinical Translation recommend that animal-human chimera research should not be pursued if it involves breeding part-human chimeras together that have the potential to form human eggs and sperm.
Additional Resources
- Genetic Literacy Project’s FAQ on gene editing
- Library of Congress summary of Japan gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
