7.1. Introduction of Advanced Medicines into Clinical Practices in Japan

pp. 127-128 in Bioethics and the Impact of Human Genome Research in the 21st Century

Author: Fumimaru Takaku (President, Jiji University)

Editors: Norio Fujiki, Masakatu Sudo, and Darryl R. J. Macer
Eubios Ethics Institute

Copyright 2001, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.

The introduction of new medical technologies into clinical practice often faces severe difficulties in our country. A good example of this is organ transplantation from brain-dead patients. The first example, a heart transplantation from a brain-dead patient which was carried out at Sapporo Medical School more than 32 years ago, was severely criticized by the mass media of our country. The diagnosis of brain death for the donor patient, as well as the necessity of heart transplantation to the recipient, was doubted even within the medical profession. A citizens group opposed to transplantation from brain-dead patients brought a suit against the surgeon who performed the operation, although he was not indicted. After this such transplantations remained frozen from many years. The bill on Brain Death and Transplantation passed the Diet in 1998. It required more than 4 years, including the time spent on discussion in the government committee on transplantation from brain-dead patients. Transplantation from brain-dead patients finally started in 1999, however because of the over-complicated donor format (for obtaining a donor card) for expressing the willingness to donate organs, and because of the necessity of obtaining approval not only from the donors themselves, but also their families, only 7 organ-transplantation from brain-dead patients had been performed by the time of this report. Violation of the privacy of donors and their families by heated mass-media reporting, and the resultant refusals by the families of possible donors are also said to be one of the reasons why the number of patients receiving transplantation from brain-dead donors in our country remains so low. Our Brian Death Act does not permit donation from brain-dead patients under the age of 15. As a result a considerable number of sick children who need a transplant still have to go abroad to receive treatment to countries such as Australia and the United States, which themselves already have a chronic shortage of donor organs. The mass-media here beautifies this as the story of many people generously donating money to support these families, however this state of affairs in our country has received strong international criticism.

After the report from England in 1997 of the production of Dolly, the cloned sheep, a sub-committee to discuss human cloning was established under the Bioethics Committee of the Science and Technology Council of our government. After discussion lasting over six months the sub-committee arrived at the conclusion that human cloning should be forbidden by law. This bill is expected to pass during the present Diet session. Under it the penalty for infringement will be a fine of up to 10 million Yen, and up to 10 years imprisonment.

I have heard that there is opposition to this bill from some Diet members belonging to the anti-government parties.

A sub-committee to discuss problems relating to human embryonic stem (ES) cells was also established under the Bioethics Committee of the Science and Technology Council. This arrived at the conclusion that making and using human ES cells should be permitted under strict regulations, supervised by both intramural and government review boards. Scientists who plan to study human ES cells have first to submit their study plan to the relevant institutional review board (IRB). After obtaining approval from the IRB the study plan has to be examined by the governmental review board, and only after passing this hurdle can research be started. This is the same system in force for the approval of clinical gene therapy trials in this country.

However, as far as I know plans for research on human ES cells have yet passed any IRBs. Furthermore the governmental committee to review plans for ES cell research has not yet been established. It is also said that obstetricians in this country are very reluctant to supply unused fertilized eggs for use in the establishment of ES cells.

The government "Post-Genome Age" "Millennium Project" has started this year. This project is focused on research on the medical uses of the products of the Human Genome Project, regenerative medicine, and the rice genome. In the project covering the medical uses of the products of the Human Genome Project, studies on the relationships between single nucleotide polymorphisms (SNPS) and susceptibility to life style-related diseases such as diabetes mellitus, hypertension, dementia, cancer and allergic diseases such as asthma are the main focus of research. Studies on the relationship between SNPS and individual sensitivity to certain drugs as well as susceptibility to the adverse effect of drugs have also been selected for special attention. To draw up fundamental principles to cover the bioethical issues related to research on the human genome, a sub-committee on human genome research was established under the Bioethics Committee of the Science and Technology Council of our government, the report of which was published earlier this year. This report was titled "Principles to be observed by researchers during their conduct of human genome research". Related to this the Ministry of Health and Welfare drew up guidelines for the conduct of human genome research in government institutes. Researchers have complained that these guidelines are too strict and will interfere with research on the human genome in our country.

Amongst the Japanese a stigma is still attached to words such as DNA, heredity and hereditary disorders. The counseling system for patients with genetic disorders and their families is still very under-developed in our country and the number of qualified counselors is still low. As one of the reasons for this underdevelopment of genetic counseling I can point to the fact that genetic counseling has not been covered by the health insurance system. In our country, as in others, public acceptance is essential for the introduction of advanced medicine into clinical practice. Researchers and clinicians involved in the introduction of advanced medicine need to make every effort to educate the public about its benefits and cost-effectiveness.


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