Introduction

In this paper I would like to concentrate on three important and very recent developments in the area of organ transplantation in Japan. First, I would like to discuss the now infamous heart transplantation conducted by Dr. Wada in 1968 and analyze the reaction of the Japanese public exactly thirty years ago [1]. Second, I would like to address the unique Japanese practice of using live donors almost exclusively for organ transplantation, particularly in the cases of kidney and segmental liver transplantation. Third, I would like to analyze the background process for making the new Organ Transplantation Law which has been effective since October 16th, 1997.

Aftermath of the First Heart Transplantation in Japan

I still remember the big headline of the newspapers praising and admiring Dr. Wada's performance of the first heart transplant on 8th of August, 1968 [2]. Many Japanese did not understand the full significance of this case and the need for investigation of possible criminal liability by the public prosecutor. In the end, the case was dismissed by the Sapporo Prosecutor's Office due to the lack, distortion, and concealment of major related medical records, as well as on the basis of medical experts' opinions and evidence of witness. As a result of this non-indictment decision, it is quite ironic that in 1970, two years before the American Hospital Association's Patients Bill of Rights was declared, a Japanese activist group endorsed a declaration of Patients' Rights, at a meeting in Tokyo condemning Dr. Wada's performance of heart transplantation [3].
The key issue in the Wada case was the clear disregard and neglect of the human rights and human lives of the two patients involved. The fact that the donor became a candidate for organ harvesting much earlier than Dr. Wada originally mentioned promoted serious questions about the extent of the medical treatment given to this victim of drowning in the effort to save his life. In addition, according to testimony from the members of the transplant team, the recipient's condition was not as critical and his heart was not as diseased as would make replacement with a donor heart necessary at that time [4]. The Japanese general public learned later of the extent of mismanagement in this case through mass media which were divided on the issue. For many people, the most troubling element was the lack of any guidelines pertaining to heart transplantation and the application of brain death criteria.
The concept of brain-based criteria for death was quite new and in 1968, as at present, no public consensus existed regarding a new definition of death in Japan. The Japanese were simply afraid of an unwarranted and premature diagnosis of death by physicians acting on brain criteria, and that the desire for donor organs would cut short their medical care. The fears raised by the Dr. Wada case still remain, in part because no official statement of regrets or admittance of premature performance of this transplantation procedure has been issued by Dr. Wada or by any professional medical organization such as the Japan Transplantation Society (JTS).
However, since the mid 1980s, at its own initiative, JTS has organized several series of public debates on issues raised by organ transplantation throughout Japan [5]. The JTS Special Commission on Social Problems in Organ Transplantation has been active in providing an open forum, together with various professionals such as physicians, nurses, lawyers, ethicists and journalists. It has also published documents based on these activities [6].
According to the national survey in May 1997, the numbers and percentages of individuals expressing a positive opinion on transplantation is gradually increasing in spite of the strong reluctance towards establishing legislation for organ transplantation among the Japanese public [7].
An organization called "The emergency liaison committee opposing the hasty "The emergency liaison committee opposing the hasty legislation for organ transplantation" was formed in Tokyo in May 1994, and it has been organizing several open public forums on related issues in brain-based criteria of defining death and organ transplantation. The situation might have been changed following the new legislation on organ transplantation. But the point still remains of fears of the possible tendency too easily to apply the brain-based criteria of death now justified in law. The majority opinion of this group expresses the Japanese familial empathy for continuing the process of care for the dying, and fears that this would be lost due to the sudden and forced identification of a brain-dead patient.
They also state that the notion of harvesting organs from brain dead but apparently still living bodies would not be culturally acceptable, and would cause tremendous psychological difficulties and trauma among the family members.

Organ Donation and Family Members' Decisions

Transplantation of organs from brain dead bodies is not completely banned in Japan, and in several cases organs have been donated based on offers by family members of the deceased. In the majority of these cases, however, physicians who performed these transplantations were later accused of violating existing provision of the Criminal Code of Japan against homicide, because of public failure to achieve consensus about the use of brain death criteria to declare death [8].
However, the Public Prosecutor's office and the courts are not very willing to deal with these cases efficiently enough to develop public policy on the issue. Generally speaking, the Japanese public has a tendency to avoid court resolution of disputes even in the case of medical malpractice suits, which number only about 400 annually, with about 1500 cases in the last twenty years.
In reality, the number of cases involving family consent for organ donation is very limited and even the traditional criteria for death - cessation of cardiac or respiratory functions and the lack of pupil responsiveness - are not widely applied for organ transplants except in the case of cornea and kidney donation. Integrated legislation for cornea and kidney transplantation was enacted on Dec. 18th, 1979. This former law for transplantation, which is now integrated into the new law, has regulated a procedure whereby both organs can be procured from a cadaver. Despite this legislation, however, interesting differences exist in the sources of donor kidneys between Japan and other industrial nations; while 70% of kidney donors in Japan are live donors, the opposite is true in Western countries where 70% of kidney donors are brain dead. For example, in 1990 in Japan, 741 cases of kidney transplantation occurred but only 209 were from cadavers, while in the United States in the same year, 9491 cases of kidney transplantation occurred with 7498 of the donor kidneys coming from cadavers [9]. About 80% of 141 cases of segmental liver transplantation from live donors in Japan since 1989 (as of July 1994) have four years' survival [10].
Due to the extreme scarcity of donor organs in Japan, some Japanese seek treatment and donor organs in foreign countries. There is increased criticism of this trend, because no country has a surplus of donor organs, and no reciprocal access has been granted in the Japanese health care system to foreigners.
In Japan, common features of decisions to donate organs were analyzed as follows: 1) decisions are usually made by a group or family and not by individuals' decisions; 2) the majority of decisions are not obtained through a confrontational exchange of opinions but rather through a consensus of the people concerned; and 3) strong conflicts in opinions arise primarily among members of the group which does not favour organ donation [11].
The majority of opinions against organ donation are based on opposition to the mutilation of the dead body. On the other hand, consent is given mainly because of an expressed wish for some sort of continuation of life for the deceased even through someone else's body. Even individuals who have expressed a willingness to donate organs may request the added consent of their families.
For this reason, in some facilities such as the Japan Kidney Bank, consent from family members is requested in documents even at the time of initial registration. This procedure is legally endorsed, and consent is necessary from a family member in most cases of organ donation.
This approach shows the importance of family group members in health care decision making, particularly in the case of organ donation.
A 1990 survey indicated that the sustained campaign to promote organ donation between 1979 and 1985 was unsuccessful. The survey reported that of 6284 adult respondents, including 1500 health care workers, only 0.8 percent had registered as kidney donors and only 10.7% were aware of the procedures for registration [12]. At the same time, other studies showed an increasing need for kidney donors in Japan [13]. It is clear that Japan needs a more effective method to disseminate information and to educate the general public about organ transplantation. It is hoped that increased knowledge will contribute to an increase in the number of organ donors in Japan in the future. The establishment of the Japanese Association of Transplantation Coordinators in 1992 is one of the indications that a greater number of organ transplants may become a reality.
Proponents of organ transplantation are becoming more vocal in attempting to point out the potential to save lives through organ donation and transplantation. A wide range of educational programs has been launched at all levels of Japanese society to ensure that the discussion does not focus solely on the rights of the organ donor to the exclusion of those who could benefit from an organ transplant [14].
For example, the Association for the Protection of Infants with Congenital Biliary Atresia was established in 1973 to seek treatment for these children through micro-surgery and also to provide coordination for efforts to focus the attention of the media and medical community on the need for liver transplants for various end-stage patients. This Association has led several successful campaigns and saved the lives of numbers of these infants by encouraging the donation of organs [15].
In March 1995, just before the opening of the session of the Health and Welfare Committee of the Diet to discuss the proposed pending bill on organ transplantation, a public educational symposium was held in Tokyo on the theme of "Thinking Heart Transplantation in Japan" to support the legislation. Around three hundred and forty people were present. This forum was organized by the citizens' group called the National Association for the Protection of Children with Heart Disease. Fifteen heart disease patients out of twenty who had transplantation abroad, including their family members, were in the forum. They told of their experiences and appealed for support of the necessary legislation to endorse organ transplantation in Japan.

Towards the New Law of Organ Transplantation in 1997

It is quite clear that high-technology medicine has increased the number of lives that can be saved, and that it has many benefits provided that it is practiced in accordance with bioethically appropriate standards. These standards must be regulated by national and international legislation or guidelines. The professionally oriented, exclusive and paternalistic approach of the past can only lead to repetition of past situations in which the rights of patients were ignored. I hope that discussion and education can prevent any such repetition of cases involving organ and tissue transplantation. The establishment of several governmental, professional and political organizations since 1985 has been encouraging in this regard. Some of these groups are the Commission of Life and Ethics, the Ministry of Health and Welfare, the Bioethics Council of the Japan Medical Association and the Investigation Committee of the Liberal Democratic Party, which works to evaluate issues regarding brain-death criteria and organ and tissue transplantation.
The most important one, the Ad-Hoc Research Commission on Brain Death and Organ Transplantation, established in 1990 by special legislation of the Diet, intended to conduct an intensive investigation on related issues in order that there will be some form of outcome such as national consensus possibly leading to new legislation. The majority of the Commission members supported the idea of integrated legislation dealing with brain-death and organ transplantation. However, some members, including two consultative members, strongly opposed the notion of brain-death criteria by pointing out the unacceptability of a definition of death based on brain function. The final recommendation of the Commission was a very unusual document by the Japanese standards, because it published the dissenting opinion in full, as a separate part of the final report; usually, such reports publish only a unanimous or compromise opinion [16]. While there was disagreement on the use of brain death criteria, the opponents agreed to respect the wish of a donor who has expressly given consent in a prior document. The final minority opinion of the Commission also agreed to proceed with organ transplantation but not to harvest organs from individuals who have not yet been declared brain dead, but are considered still living [17].
This Commission's final report was issued on January 22nd 1992, and finally the new organ transplantation law has passed Diet and been effective since October 16th 1997. Since proposal of this law to the Diet in April 1994, the Diet carried it over to the following session every year until 1997 without having further investigation in the Health and Welfare Committee of the House of Representatives.
This new law confirms the importance of family members in medical decisions by granting them power of consent to organ donation on behalf of newly deceased family members. Therefore, even if the deceased was registered as a possible donor, the surviving family may refuse organ donation. The new organ transplantation law identifies the circumstances in which the family can and cannot decide for organ transplantation on behalf of a brain dead individual who left no specific written evidence of his or her wishes. In light of the draft legislation from the Inter-Party Council in which the family is granted authority to make decisions on behalf of the patient, often based on rather vague evidence, it is interesting to note that the earlier report of the original Ad-Hoc Commission did not extend the principle that the decision regarding organ transplantation should be based on respect for the wishes of the individual patient insofar as possible. This was a rather closer conclusion to "The Final Report on Brain Death and Organ Transplantation" of the Bioethics Council of the Japan Medical Association, which was issued in January 1988.
The new law of 1997 provided the basic approach of respecting the intention to donate organs on the part of the patient and a notion of the voluntary nature of organ donation; however, it also state that a person's expressed desire to donate organs will be honoured only if family members do not object and if the intention of the person is clear in stating the acceptance of criteria for death based on brain assessment [18].

Concluding Remarks

In Japan, generally speaking, the process of making laws has been in the hands of professionals, government appointed academics, and bureaucrats noted to have vast knowledge and experience in the particular field in question. Professional credentials are of great importance to the Japanese in an official decision-making process. This process traditionally has not sought input from the public.
However, since the mid-1960's, there has been an enormous interest in the general public about issues in bioethics. Members of the public have become vocal and involved participants in areas of concern traditionally regarded as restricted to professionals in the historically paternalistic field of medicine.
The rapid progress and development of medical and scientific technologies have demanded participation and cooperation between local grass-roots lay people and medical professionals to ensure better decision-making and respect for the autonomy of patients [19].
Unfortunately, most professional Bioethical Commissions in Japan exclude from their membership a variety of professionals, any representation of the lay public, and any female members. The discriminatory membership of these committees has undermined the general public's confidence in and support for these bodies. In addition, the deliberations of these Commissions traditionally have been closed to the public except in rare instances when concurrent but separate public hearings were held on particular issues. Reasons for continuing to hold closed meetings range from a concern that frank debate will become impossible to concerns about the secrecy of potentially patentable procedures. Whatever the reason, the more universal bioethical principle of reflecting public opinion in the process of making public policy on issues of life and death is very underdeveloped in Japan, which results in frustration and loss of confidence in the ability of these commissions on the part of the public.
A radical shift in the mentality of both Japanese medical professionals and legislators must occur to embrace the new and rapidly developing medical technologies and developments in science, and to meet the needs of suffering patients. In order to break through in the legalization on organ transplantation and brain-death criteria, the lay public's influential contribution was developed positively [20].
In the absence of a real "Bioethical" approach to public policy, which demands public participation and open debate, fundamental human rights of suffering patients, potential organ donors and organ recipients will not be seriously reflected in the Japanese legal system and public policy process.
The issues raised here in the Japanese social and cultural context are really matters of human life and human rights which should be respected in the whole process of bioethical decision-making at the individual private and national public levels, and in an international context of bioethical guidelines.
Debate on brain-based death criteria and organ transplantation during the last thirty or so years in Japanese society shows the clash between modern scientific culture, represented mainly by medicine, and the traditional Japanese cultural ethos concerning life and death. It also shows the enormous impact of challenges arising from the development of the bioethics discipline. Even the universal hope through science and technology to benefit human life, such as by organ transplantation, could not be applied easily without an internal struggle of the cultural mind of the people of Japan.
However, our starting point should be a recognition of the existence of injustices, and our continuous involvement in the struggle against injustices, particularly to achieve a better system of welfare and to advance the health of the people according to the well accepted principles of the Universal Declaration of Human Rights developed by the United Nations in 1948, which marks its fiftieth anniversary in December 1998.

References

1. Wada, Juro, et. al. "The Clinical Medicine of Heart Transplantation Surgery." Nippon Iji Shinpo (November 16, 1968): 3-6.
2. Kimura, Rihito. "Japan's Dilemma with the Definition of Death." Kennedy Institute of Ethics Journal 1 (2) (June 1991): 123-131.
3. The Group for Condemning Dr. Wada's Heart Transplantation. "Human Rights Declaration of the Patient." Tokyo: The Group for Condemning Dr. Wada's Heart Transplantation, July 27, 1970.
4. Fujimoto, Teruo. "Application of Heart Transplantation from Pathological Point of View." Saishin Igaku 25 (May 1970): 1137-1146 (in Japanese).
5. Akiyama, Nobuo. How do we Think About Organ Transplantation? Tokyo: Kodansha, pp.141-143 (in Japanese).
6. Special Commission on Social Problems in Organ Transplantation, Japan Transplantation Society, ed. The Approach to Organ Transplantation Series. Vol. 1-5. Osaka: Medika Shuppan, 1990 (in Japanese).
7. The Yomiuri Shimbun, National Opinion Poll, May 9, 1997, p. 29. This poll found that 50.4% of Japanese are in favor of organ donation by accepting the use of brain death criteria.
8. "The Simultaneous Transplantation of Pancreas and Kidney of the Brain Dead Woman to the Diabetes Patient at Tsukuba University on September 26, 1984." In: Machino, Saku. ed. Shinzansha, 1993. pp. 30-41. In this well publicized case, the organ recipient died after one year.
9. Yasumura, Tadaki, et. al. "Kidney Transplantation." Geka Shinryo 34 (7) (July 1992): 850-851 (in Japanese).
10. Kawasaki, Seiji and Makuuchi, Masatoshi, "Present Situation of Liver Transplantation in the World and Its Future Perspective in Japan." Geka Shinryo, Vol. 37, No. 2 (February 1995) pp. 147-152 (in Japanese).
11. Coordinating Council for Kidney Transplantation (CCKT). Kidney Transplantation. Osaka: Medika Shuppan, 1992. pp. 23, 31-8 (in Japanese).
12. CCKT. op. cit., pp. 24-25.
13. CCKT. op. cit., pp. 45-57.
14. Aoko, Shinichi, "How to Increase Cadaver Organ Donation in Japan: A Transplant Recipients' Approach." Transplantation proceedings 24 (%) (October 1992): 2064-2065; Transplant Recipients International Organization (TRIO) Japan, ed. Transplantation medicine in the Future. Tokyo: Haru Shobo, 1993. pp. 103-24 (in Japanese).
15. Fujiwara, Hide. "When Three Persons Got Together, They Were Able to Do Many Things: The Past 14 Years of History of the Parents' Association of CBA Children." Social Work Studies 12 (4) (Winter 1987): 215-219 (in Japanese).
16. Ad-Hoc Research Commission on Brain Death and Organ Transplantation. "On Major Issues Relating to Brain Death and Organ Transplantation (Recommendation)." Tokyo: Ministry of Health and Welfare, January 22, 1992, op. cit., pp. 24-33.
17. Ad-Hoc Research Commission, op. cit., pp. 31-33.
18. Zoki no Ishoku nikansuru Horitsu (The Law concerning Organ Transplantation, July 16th, 1997. The Law No. 104 of 1997) Article 6., Sections 1. 2. 3. (Removal of Organs)
19. Kimura, Rihito. "Ethics committees for 'High Tech' Innovation in Japan." Journal of Medicine and Philosophy 14 (1989): 457-464.
20. Kimura, Rihito. "Bioethics as a Prescription for Civic Action: the Japanese Interpretation." Journal of Medicine and Philosophy 12 (1987): 267-277.