"What's up with Japanese Biomedical Law"? - A Research Report

Ⅰ. Three causes to come to Japan in order to examine Japanese biomedical law:

1. Scientific, legal and ethical component: Japan takes a leading position in biomedical sciences and is at present the single Asian country, which has already established detailed legislation in some biomedical fields and spearheads the controversial ethical and societal discussions among all Asian countries.
2. Legal and historical background: In comparison to Western countries, the legal system and ethical and historical background of the legislation are seriously different in general and generate different legal and ethical attitudes also in biomedical issues.
3. Economic component: The highly growing up of the Asian economy and the speedy technological, legal and societal development generate new challenges for the public, the governmental systems and research community not only in Asia, but especially also in Western Countries and yield also a stronger global competition between Asian and Western countries in biomedical research and pharmaceutical product development.

Ⅱ. Legal subjects and main legal aspects for the analysis of Japanese biomedical law

The "anchor" has been the Japanese Constitution, the Human Cloning Act (HCA) and the "Guidelines for Handling of a Specified Embryo" as well as the "Guidelines for Derivation and Utilization of Human Embryonic Stem Cells". Both, the Act and the Guidelines, are up to now the single legislation in Japanese Biomedical Law in a narrow sense. Other relevant regulations also needs to be considered in this framework, e.g. the Eugenic Protection Law, the Maternal Protection Law, the abortion rules within the Criminal Act (Art.212ff.), the law of torts and damages (Art. 721, 886 Civil Law Act), the Organ Transplantation Act, the guidelines of the medical doctors' associations and of the JFGG (Japanese Society for Obstetrics and Gynaecology). In addition, some important reports from the MEXT, the MHLW and the Council of S&T has to be noticed in this context, especially the report of the Committee on Bioethics of the Council for S&T from July 2004 on handling therapeutic cloning and the production of fertilized human eggs for fertility treatment research (within two new Guidelines).

The main legal questions, which have been analyzed, are the following:

1. the legal term "human dignity" in Japan and its legal definition in comparison to Art.13 of the Constitution ("the respect for the individual" - kojin no songen) and to the definition of "human dignity"/"Menschenwuerde" in Western countries
2. the "status of the embryo" and the "beginning of life": is the embryo a "human being" in Japan and protected by "human dignity"? When does life begin?
3. the rights of the individual and the concept of "common welfare" (Art.11, 13 JC)
4. the system of setting "Administrative Guidelines" instead of "Acts"
5. the historical, religious and ethical background ("Kant vs Buddha"; Monotheism vs plurality of religions)

Ⅲ. Results

Ad 1., 5.) As the term "human dignity" is an imported term from the West and doesn't exist within the Japanese Constitution and other Law, a widespread ignorance, nescience and lack of knowledge what human life and human dignity constitutes in the context of biomedicine has to be noticed. Thus, there doesn't exist any positive or negative definition of the "human embryo" and its legal and constitutional protection, the "beginning of life" or the limits for academic freedom, neither in the legal, nor in the ethical field. Art.13 ("kojin no songen"- principle) is not applicable in this context, since this principle has to be considered in a more narrow sense and is therefore rather related to the "social rights for human beings", i.e. the guarantee of a happy life, the right to work, the right of personal autonomy, the right to property et al. Some Jurists (Prof Ida et al.) and the Council for S&T - influenced by western thinking - have made some attempts to create a concept of "human dignity" in a general manner as well as for case-by-case use. According to this, human dignity has to be considered as a more comprehensive and abstract legal term, which embraces the "respect for human life" and the "value of human life" in a general manner; all human beings have their own identity and should be respected and be treated equally because of their "dignity" - a definition, which is quite close to the principle of the "protection of human rights". In the case of reproductive cloning, this group has defined 4 elements, which compose "human dignity" only in the case of reproductive cloning: The instrumentalization of the human being, the presetting of genetic particularity, the violation of the individuality and the confusion of the societal and family order. These elements have finally launched the total ban on reproductive cloning within the HCA ("Transfer-Prohibition of cloned embryos"), which bans all kinds of human reproductive cloning, and also special types of hybrids and chimeras (Art.3 of the HCA). Case-by-case definitions seems to become widely accepted among the Jurists and the government and could be a convenient solution to overcome the ignorance of the internationally acknowledged term "human dignity". This handling is absolutely different from most of the Western Law and Biolaw: The Constitutional systems in most of the European countries, especially in Germany, are bound on the philosophy of the "humanism", the philosophy of Kant and the Catholicism Dogma and determine the beginning of human life and the absolute protection of human beings with the union of sperm and egg (=embryo). Beside international Declarations, like the Universal Declaration of Human Rights (Art. 1:"all human beings are born free and equal in dignity and rights"), the "Objektformel" of Kant - "a human being is a purpose of itself and may not be degraded to a mere object" - has become the main objective of the German Constitution: "The human dignity is indefeasible" (Art.1). In Japan however, the "holistic approach" and the plurality of religions and ethics has generated the fact, that "nobody understands the principle of human dignity as that human beings should be granted dignity because of the differing status of human beings and animals in the system of existence", Prof Shimazono stresses.

Ad 2.) Referring to the Council of S&T, Prof Ida et al., the embryo is not a human being yet and not a thing neither, but a "germ of human life", i.e. the early beginning of human life; This position is located between the concept in most of the western countries and the extreme positions of P. Singer et al., who define the embryo as a mere cell cluster or lump.

In spite of this definition one has to underline, that neither the beginning of life (embryo and fetus), nor the end of life ("brain death" versus "heart death") is clearly defined in Japanese Law, since these items appears to be often ignored within the public and the government. The discussions have been started much later than in the West, don't proceed effectively or are confused; the discussions on Organ Transplants or on genetically modified organisms (GMO) at present are prominent examples. Nevertheless, as a legal consequence, the "germ"-definition has generated the principle, that the beginning of life, i.e. the embryo, should not be created for other purposes than for reproduction (="ART"-embryo); this principle is widely accepted within the research community, the public and among the Jurists.

However, this principle is opposed to the technology of therapeutic cloning and production of human fertilized eggs for clinical and research use, since an embryo needs to be destroyed for that techniques. From a legal point of view, the solution for the ongoing discussions concerning the permit of therapeutic cloning for basic research and the production of fertilized eggs for clinical use in new guidelines (based on Art.4 of the HCA) might be the determination of this principle with two exceptions: First, for supernumerous frozen embryos, which are left from artificial fertility treatment (=ART-embryos) - with the consent of the parents (sic!) -, and second, for therapeutic cloning (="SCNT"-embryo), since this technology is an artificial process without any fertilization of human egg and with the purpose of healing sick people and research of latent diseases, like Alzheimer, Parkinson and Diabetes. Whether the "utage-no ato"-case, in which the Supreme Court has been laid down stricter legal conditions for "personal rights", could be used in similar cases, in which the personal rights of the patient or donor have been injured, needs to be investigated case-by-case.

Ad 3.) The individual interest is legally considered as part of the common interest, since the individual is part of the community and needs therefore be protected by governmental power. Nevertheless, one has to notice, that "life style" has been changed since 40 years and has generated a process of increase of individual value and a kind of "individualism" with great influences on the whole social system in Japan. Hence, the concepts of "common welfare" and "individual value" tend in practice towards the Western concept of "individualism".

Ad 4.) Setting Guidelines and not Acts in order "to regulate" biomedical research (at present: Guidelines for "Derivation and Utilization of human ES cells, for "The Handling of "Specified Embryos"; soon also for "Therapeutic cloning", and "Production of Fertilized Eggs for Fertility Treatment Research"), is absolutely contrary to the legal handling in Western countries in these kinds of sensitive and controversial issues. Nevertheless, in Japan, Administrative Guidelines are a common and ordinary type of regulation, since they are an effective, flexible, and speedy tool with lower resources costs for the legal handling of the rapid developments in biotech and biomed. In addition, neither the government nor the scientists are interested in a highly regulated S&T sector, since they want to provide S&T research as much as legally and ethically possible. Most of the Guidelines in general can therefore be defined as a result of a "political negotiation process" between both parties and the public. In addition, neither the silent majority (=the public), nor the vocal minority (=researchers) appears to trust in the parliament and the parliamentarians' knowledge in these highly complicated legal and ethical issues. However, regulating biomedical issues exclusively in Administrative Guidelines is intransparent, opposed to the Constitution and should therefore be reconsidered.

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Recommendation: The Japanese Biomedical Law is standing in the early stages of a long stretch of way of "regulating human life". The kickoff was well from a legal point of view, but the partly noticed absence of discussions and knowledge in biomedical issues within the whole society and the governmental organs should be replaced by a more transparent and democratic system, a more precise legislation and efficient organized governmental backing - combined with a broad educational and training system.

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