Further, the Ministry of Health and Welfare has set-up the Central Evaluating Committee for Gene Therapy to carefully review the validity of all proposals. Agencies in the United States and many European countries have been working already in the same direction, in attempts to exclude any inappropriate gene therapies. However, the gene therapies currently available are still in the experimental or trial stage. On the other hand, if the pre-gestational gene diagnosis were admitted, there would be some possibility of controlling birth based on the results or of performing gene therapies on the premature embryonal cells. So when most of the other problems may be solved in the future, this latter issue will need to be discussed once again.
Gene therapy appears to be less mired in ethical problems than is gene diagnosis.
Nevertheless, every medical institute planning to institute a gene therapy program is required to have its own ethics committee to evaluate individual therapy proposals. Such evaluation based solely on the written proposal materials may not be adequate, and in addition to ethics committees, the third section of the proposed division of gene diagnosis and therapy would deal with practical guidance and detailed monitoring of therapy. In summary, I hope I have demonstrated several critical points in my presentation or current ethical considerations related to gene diagnosis and therapy. These are, the right to not know, the inadmissibility of the right to not divulge, protection of human rights, with the necessity of a confidential management system for genetic information, the ideas that genetic information is essentially the property of the testee and not of the medical authorities and that informed consent is required for the testing also, and current and future considerations in the prenatal or pre-gestational application of gene diagnosis and embryonal treatment. In order to resolve these problems practically, I proposed the necessity for a division of gene diagnosis and therapy and for in-hospital ethics committees devoted solely to issues in genetics in any hospital performing gene diagnosis and therapy.