Regulation of the preimplantation genetic testing in Japan: challenges for the clinical application

Abstract

Introduction Preimplantation genetic testing (PGT) has been performed in many countries for more than 25 years. However, in Japan, number of PGT conducted cases has been very small, and reasons for that are seemed not to be well known in other countries. In this presentation, we would like to explain the PGT regulation system in Japan, and discuss its implications and challenges for clinical application. Material & Methods Since the Japanese Society of Obstetrics and Gynecology (JSOG) has issued guidelines for PGT, we explored the JSOG guidelines and other related documents. Points of consideration regarding PGT regulation were extracted, and clinical implications were discussed. Results PGT in Japan is not illegal, as there is no legislation related with PGT. However, JSOG has set a strict regulation for PGT, since 1998. Although JSOG does not have legal power, specialists who perform PGT are supposed to be members of JSOG, and therefore, they are obliged to follow the JSOG guidelines. PGT guidelines of JSOG have been formulated as ethical guidelines, because it has been believed that selecting embryos can be ethically problematic, and there seems to have been a strong opinion that which embryo should reach the term of delivery has to be dealt with by the hand of the divine being, although the idea seems not to be related with any specific religious thoughts. According to the JSOG guidelines, PGT needs to be conducted under the status of research, only at a medical center approved by JSOG specifically for PGT. If a patient who meets the research criteria wants to undergo PGT, after the information provision, including methods of PGT, predictive results, safety, and other options, etc., patient's strong desire for PGT has to be confirmed. Then, the patient needs be referred to a different medical center to have a genetic counseling session by a third-party provider. After that, each case should go through not only the hospital's ethics committee, but also JSOG's ethics committee. JSOG's ethics committee examines every case separately, and approves PGT only with extremely severe childhood onset monogenic conditions or couples with chromosomal rearrangement who had more than two miscarriages. Although a new JSOG research study of preimplantation aneuploidy screening with CGH microarray has been started last year, it is strictly controlled by JSOG, and performed at four centers only with strict selection criteria of the participants. Due to this kind of strong regulation of PGT in Japan, it is still not an option discussed in a standard practice, and the number of PGT cases has been very small. While the PGT option is not easily accessible, there have been some people having PGT outside of Japan, but, it costs much more. As JSOG guidelines have been determined within the professional society, this regulation is not well known by the general public, and there has not been any public discussion on this matter. Conclusions Although PGT has been recognized as an effective and useful technique for monogenic conditions, chromosomal rearrangement, and aneuploidy, Japanese situation has been very different compared to other countries. There may be some people who want PGT but cannot use it in Japan because of this regulation, and these people may give up having children, or try to have prenatal diagnosis, which availability is also limited in Japan. It may also be a problem that most medical professionals do not know the recent development of the PGT technique, as PGT has not been commonly practiced in Japan. Further discussion may be needed for this issue, including whether or not the JSOG guidelines need to be reconsidered from a different point of view.