Section 3: Investigation in Japan from the Legal Viewpoint
The progress achieved in reproductive science and technology has brought about situations for which existing legal systems are not expected to cope. As a result of this, responsive actions are taken on the basis of inferential interpretation of the existing legal systems or the necessity of new legislation is stressed with the aim of coping with matters to which none of the existing laws are applicable.
Regarding application of reproductive technologies including, among others, in vitro fertilization, artificial insemination, donation of sperm and eggs, and surrogacy, as well as regarding studies using fertilized eggs, embryos and any other relevant matter, various reports have already been published from the viewpoints of the Constitution of Japan, Japanese criminal and civil laws, and other regulations. These reports contain the legal viewpoints for reproductive medicine and for research and development in advanced science and technology fields. In this Section, the authors will introduce some key reports and summarize the points stressed in these reports.
(1) Constitutional Viewpoint
The following 3 reports address this matter from the viewpoint of constitutional law.
<1> Akira Hasegawa "Freedom and Regulations in Artificial Reproductive Medicine" (Comprehensive study supported by subsidies for scientific research in the year 1993: (A) Research Result Report "Legal Problems Surrounding the Right of Personality in Reproductive Medicine"; Research supported by these subsidies will be hereinafter referred to as "Subsidized Research" )
<2> Hiroyuki Takai "Constitutional Analysis of Reproductive Medical Problems" (Subsidized Research)
<3> Ichiro Hokimoto "Gene Manipulation and Law"
Hasegawa's report <1> stresses that the important issue to be addressed in connection with utilization of artificial reproductive medicine is the individual's freedom of selection, which is a fundamental human right. In other words, this report takes the stand that any regulation imposed on activities of the individual must be justified only when such activities under regulation will violate the individual's rights: regulations to be imposed on artificial reproductive medicine should be the minimum necessary to secure the individual's freedom of selection to the maximum extent, and free utilization of artificial reproductive medicine should be accepted.
The report by Takai <2> acknowledges that the Constitution of Japan looks to the family as the foundation of public order: the State cannot be allowed not to intervene in reproduction of any form as long as such reproduction has been consented by the individuals concerned, but such intervention by the State shall not be contrary to the Constitution. The report points out the following 3 articles which may be related. (Of these 3 articles of the Constitution, Articles 13 and 24 are related to reproductive medicine and Article 23, to research and development of advanced science and technology.)
(a) The right to the pursuit of happiness prescribed in Article 13 of the Constitution of Japan
As part of what constitutes this right, there exists the right of personal autonomy and the right of autonomy, according to which the individual has the right to make his/her own judgment regarding his/her specific personal affairs, without interference by the public power. These affairs can be divided into the following categories: those which are involved in the treatment of the individual's own life and body; those which are involved in forming and maintaining a family; those which are involved in reproduction; and those which are involved in any other matters.
(b) The principle of equality of the sexes prescribed in Article 24 of the Constitution of Japan
Examination is required to determine if regulations based on biological characteristics may facilitate or accelerate oppression of the woman.
(c) The academic right guaranteed in Article 23 of the Constitution of Japan
From the viewpoint of protecting gametes, embryos, fetuses and any other relevant matter which lead to the birth of a child, imposing regulations on reproductive medical studies and implementation of such studies may be allowed in many cases.
On the other hand, careful considerations are required to impose regulations on utilization of gametes or embryos which will not be used in reproduction. (For example, imposing regulations on the basis of objectives is not permitted, whereas the possibility of imposing regulations on means or procedures may be investigated.)
In addition, Hokimoto's report <3> asserts that securing the rights of scientists to perform studies is based on the principles of the Constitution. His report discusses how and under what conditions studies which become limitless and opposed to other people's or citizens' health and safety as well as to social ethics, can be controllable. This report points out the necessity of people's control over studies of gene manipulation related to germ cells and any other relevant studies, and proposes the necessity of both control by people and control through the use of administrative procedure laws.
As described above, the viewpoint of relation to the Constitution indicates that the right of personal autonomy and the right of autonomy (that the individual corresponding to a parent shall have) described in Article 13 of the Constitution of Japan and the academic freedom guaranteed in Article 23 of the Constitution of Japan are the issues that need to be considered when using reproductive medical technology. (The relation between advanced science and technology and academic freedom will be described in detail separately.)
(2) Viewpoint of Civil Code
The following reports address this matter from the viewpoint of civil code.
<1> Michiko Ishii "In vitro fertilization between non-spouses and problems in connection with the Family Act" Horitsu-No-Hiroba, September 1997 Issue
<2> Michiko Ishii "Artificial insemination in relation to the Parent-And-Child Act" Case Study Times No. 92
<3> Norio Higuchi "In vitro fertilization between non-spouses: artificial insemination, family and laws" Horitsu-No-Hiroba, September 1998 Issue
<4> Norio Higuchi "Artificial insemination and parent-and-child relationship" Jurisuto No. 1059
<5> Yasuko Hitomi "Parent-and-child relationship in artificial insemination" Case Study Times No. 747
<6> Kouki Sugano "Validity of surrogacy agreements in relation to public policy or good morals" (Subsidized Research)
<7> Hidehiro Takashima "Problems in gamete donating agreements in the case of in vitro fertilization between non-spouses" Horitsu-No-Hiroba, September 1998 Issue
<8> Yutaka Tejima "Notes regarding informed consent" (Subsidized Research)
<9> Kunihiko Shoji "Regulations on artificial reproductive medicine in Japan: some characteristics and problems" (Subsidized Research)
<10> Takuo Yamada "Necessity of legal regulations: from the view point of civil code" Sanka-to-Fujinka, April 1998 Issue
From the viewpoint of civil code, the key issues requiring particular attention are involved in (i) the legal position of a child in connection with the Family Act and (ii) the validity of gamete donating agreements or surrogacy agreements (in relation to public policy or good morals). The issues to be addressed from the viewpoint of civil code are therefore not related to advanced research and development but to reproductive medicine.
(i) Legal position of the child in connection with the Family Act
Report <1> above, by Ishii, points out that identification of the mother and/or the father in the case of in vitro fertilization between non-spouses is an issue to be addressed in connection with the Family Act. In Japan, there exist no specific laws concerning the parent-child relationship for artificial insemination: for the father, a child will be presumed to be the child of the husband according to the presumption of legitimacy prescribed in Article 772 of the Civil Code and for the mother, a mother-and-child relation will be based on the fact of delivery (which was a Supreme Court Judgment on April 27, 1962). However, there are cases in which doubts may be raised, e.g. artificial insemination using sperm derived from not the husband but a donor, in vitro fertilization which is performed after death of the husband using sperm of the husband which has been retained, or delivery using an egg derived from not the wife but a donor that is fertilized in vitro. In addition, this report focused on the right of the child thus born to know the donor of the gamete and the issue of not violating the privacy of the donor, and stresses the necessity of new legislation to define the parent-child relationship for children born through artificial insemination (note that this matter is also stressed in Ishii's report <2>).
Similarly, the report by Higuchi <3> focuses on the issue of defining the legal position of a child (identification of the parents, identification of the individual who has the obligation of bringing up the child, and inheritance), the child's rights (the concern that the child may be discriminated against, the concern that merchandising of the child or treating the child as a product may occur, and the right of the child to know the facts related to his/her own birth), and future influences on society as a whole. This report then indicates that the existing Japanese legal parent-child relationship will not be able to accommodate these changes, which is problematic. (The same problem is pointed out by Higuchi's report <4>, which introduces US precedents, and by Hitomi's report <5>. Yamada's report <10> stresses problems involving the parent-child relationship and the child's interests.)
(ii) Validity of gamete donating agreements or surrogacy agreements (in relation to public policy or good morals)
The report by Sugano <6> introduces foreign cases regarding the validity of surrogacy agreements. In the US, the High Court of New Jersey State adjudicated (on February 3, 1988) in the case of Baby M that the surrogacy agreement was contrary to public policy or good morals and therefore invalid, whereas the High Court of California State made the judgment (on May 20, 1993) in the case of Baby C that the surrogacy agreement was not contrary to public policy or good morals. In Germany, the Embryo Protection Act prohibits surrogacy. In the UK, the Surrogacy Arrangements Act prohibits any surrogacy agreements for the purpose of profit making and prohibits any advertisements for the purpose of recruiting surrogate mothers. In these two countries, surrogacy agreements will not be illegal as far as they violate these prohibitions. In France, the Court of Appeals adjudicated (on May 31, 1991) that surrogacy services were contrary to public policy or good morals. This report <6> introduces that in Japan also, some academic individuals are not in favor of surrogacy as it may be contrary to public policy or good morals and it stresses the following matters to be taken into account when evaluating this issue: nature of value to be received in exchange for surrogacy services; morality of bearing a child who is to be handed over to others; shock given to the child when he/she is aware of the details of his/her own birth; human rights of a surrogate mother; informed consent from a woman who wants to be a surrogate mother; and concern of endangering children's welfare. The report concludes that surrogacy agreements should be considered invalid because they are contrary to the order of marriage and of parent-child relationship and therefore are contrary to public policy or good morals (in accordance with Article 90 of the Civil Code).
Takashima's report <7> discusses gamete donating agreements in the case of in vitro fertilization between non-spouses. It claims that establishment of a gamete donating agreement requires individual parties who want to make the agreement and their expression of will to make the agreement and that these factors for the establishment of the agreement are not in themselves problematic. However, the report also claims that in order for the agreement to be effective, the detailed acts prescribed by the agreement shall be identifiable and feasible and in addition, shall not be contrary to peremptory norms of the laws (jus cogens) nor to public policy or good morals. The report continues to point out that the agreement may therefore be judged invalid because it is contrary to public policy or good morals, when matters taken into account in connection with public policy or good morals indicate the waiving of parental power (which endangers the family order and destabilizes the child's legal position) and the placing of commercial value on gametes (which, in particular, involves medical invasion required for donating an egg and may indirectly force the needy to donate gametes).
This report <7> also stresses that even if the gamete donating agreement is considered to be not always contrary to public policy or good morals, there exists another legal problem in that it is not appropriate to surrender the gamete in a forced manner.
(iii) Others (Accountability of medical doctors)
In addition, the report by Tejima <8> discusses the accountability of medical doctors, although this is not an issue only applicable to reproductive medical technology but also to damage claims in malpractice suits. The obligation of medical doctors to provide explanations can be divided into four categories: (a) accountability as an obligation to avoid results; (b) accountability as presupposition for obtaining consent; (c) accountability as presupposition for transfer; and (d) accountability as subsequent report (reporting the outcome). Informed consent is included in Category (b). Problems involved in informed consent are as follows: insufficient availability of data that should be required, ways in which medical doctors provide information, intellectual aspects of patients who receive information, and attitude in which a decision is made.
In addition, the report by Shoji <9> introduces the voluntary regulations regarding productive medicine which were proposed at the meeting of the Japanese Association of Gynecology and Obstetrics.
In summary, both regarding (i) the legal position of the child in connection with the Family Act and (ii) the validity of gamete donating agreements or surrogacy agreements (in relation to public policy or good morals), there exist no established views in Japan and accordingly, the above reports identify the current problems and point out the necessity of future discussion and calling for necessary legislation.
(3) Viewpoint of the Penal Code
The following reports address this matter from the viewpoint of the penal code.
<1> Toshio Yoshida "(Legal) character of pre-transplantation human early embryos and some relevant problems: in the interest of the Criminal Law" (Subsidized Research)
<2> Hisao Kato "Creation of 'a human's life' and problems in connection with the Penal Code: with special regards to legal protection of 'fertilized eggs' and 'early embryos'" (Subsidized Research)
<3> Katsunori Kai "Models of (criminal) regulations on reproductive medical technology" (Subsidized Research)
<4> Katsunori Kai "Necessity of legal regulations: from the viewpoint of the Penal Code" Sanka-to-Fujinka, April 1998 Issue
<5> Kinko Nakatani "Necessity of legal regulations: To what extent are these legal regulations allowable?" Sanka-to-Fujinka, April 1998 Issue
<6> Kinko Nakatani "Development of a life and the Penal Code" Gendai-Keibatsu-Hotaikei 3
<7> Fumio Kanazawa "Moral and legal position of human embryos" Hogaku-Ronso of Okayama Shoka University, February 1995 Issue
<8> Hisao Kato "Reproduction assisting actions (technology) and legal protection of fertilized eggs and early embryos" In the book entitled "Modern medicine and medical affairs law system", editor Masayoshi Ohno
From the viewpoint of the penal code, the key issues requiring particular attention are involved in (i) the legal character of fertilized eggs or early embryos and (ii) permissibility of and legal regulations to be imposed on studies using fertilized eggs or early embryos as well as application of reproductive medical technology (e.g. surrogacy).
From the viewpoint of the penal code, to what extent reproductive medicine and advanced research and development should be allowable and which penal provisions should be appropriate in the case of violations are discussed.
(i) Legal character of fertilized eggs or early embryos
The report by Yoshida <1> introduces different theories regarding the legal character of pre-transplantation early embryos: a theory which claims that personal character exists from the time of fertilization and therefore, the pre-transplantation early embryo is an individual who has rights; a theory which accepts that the pre-transplantation early embryo has some special position which is not identical to that of a human; and a theory which claims that the pre-transplantation early embryo is the property of the parents. This report stresses that the early embryo is a latent human but is different from people in reality and therefore, the early embryo should not be in a position where it constitutes an individual possessing fundamental rights. However, at the same time, it is not appropriate that the early embryo be regarded as property, for which the crime of destroying things is applied in the case of damage. This report <1> stresses the necessity of new legislation to protect the early embryo. (Reports <6> and <8> above also discuss legal problems involving the development of life.)
Report <2>, by Kato, focuses on legal protection of "fertilized eggs" and "early embryos." In Germany, the Embryo Protection Act prescribes regulations on the cells in the individual stages from eggs and sperm through to fertilized eggs and early embryos before implantation, and the Penal Code imposes regulations on post-implantation placenta, embryos and fetuses. In Japan, the members of the Japanese Association of Gynecology and Obstetrics proposed at a meeting their voluntary regulations concerning fertilized eggs and early embryos. The current Penal Code in Japan prescribes the crime of abortion, which provides protection of the fetus. (Note that the legally protected interests are to secure the safety of life and body for both the fetus and the mother.)
This report <2> introduces different theories: a theory which regards the life as a subject under legal protection and recognizes that the individual starts at the time of conclusion of implantation; and a theory which regards a fertilized egg not as a fetus but as an "organism" unique from that of humans or fetuses and accordingly, damaging the fertilized egg should constitute a crime of destroying things. Kato's report stresses that since the pre-implantation fertilized egg has the potential of being a human, application of the crime of destroying things is not appropriate and that other legislative resolution is desirable.
(ii) Permissibility of and legal regulations to be imposed on studies using fertilized eggs or early embryos as well as application of reproductive medical technology (e.g. surrogacy)
Kai's report <3> introduces systems employed in foreign countries. In the UK, a form of administrative penal code is used: the statutory licensing authority is established, the required procedures for obtaining a license are defined, and acts violating the prescribed licensing are punishable. In Germany, a special penal code form is employed, in which criminal regulations are prescribed. In the UK, a license can authorize certain studies using embryos before the appearance of the primitive streak (i.e. an embryo before the time at 14 days after fertilization, at which point it is considered that the embryo starts to develop as an individual). In Germany, however, using embryos for purposes other than reproduction and studying embryos are totally prohibited on the ground of respecting the dignity of the individual. This report concludes that the UK system may be more appropriate to Japan than the German system of prohibiting all uses and studies of human embryos, when considering the nature of the Japanese Penal Code, i.e. intentions of imposing regulations that are not too restricted and of waiting for the final action, and in view of academic freedom as guaranteed by The Constitution of Japan. (Note that Yoshida's report <1> points out a possible occasion in which a study of a human embryo may be permissible even if the embryo is at the stage after the time point of the appearance of the primitive streak.)
In addition, Kai's report <3> introduces that in the UK, the Surrogacy Arrangements Act imposes penalties on negotiation of any surrogacy for payment and in Germany, the Embryo Protection Act imposes penalties on individuals who attempt artificial insemination for, or transportation of a human embryo to, a surrogate mother. This report claims that it is necessary in Japan also to impose criminal punishment on commercial abuse. (Kai's report <4> introduces the Japanese style of regulatory model that was proposed by Subsidized Research.)
Report <5> by Nakatani introduces legal systems employed in foreign countries and points out ethical and legal problems regarding in vitro fertilization, for example: surrogate mothering; pros and cons for implementation of an operation to reduce the number of fetuses in the case of multiple pregnancy; for and against the means of intentionally having a baby boy or girl; problems related to so-called "designer baby" (according which a fetus at the age of 8-12 weeks of pregnancy is artificially aborted and brain cells or other tissues are isolated from the fetus for the purpose of using them in the treatment of Parkinson's disease, etc.); pros and cons for donating eggs derived from a dead women or donating aborted fetuses; and problems involved in pre-implantation diagnosis and gene therapy. This report stresses the urgent necessity of taking legal actions which can cope with the rapid progress in reproductive medicine.
In addition, Kanazawa's report <7> argues that although the human embryo should be protected as a human's life from the viewpoints of morality and the Constitution and therefore, the national government should have the obligation to protect it, none of the actually established laws give such protection to the human embryo. Accordingly, this is an area to which none of the current legal regulations can apply. This report continues to argue that at present, implementation of various studies using human embryos is not illegal, but this does not mean that studies using human embryos are legal and researchers are entitled to manipulate human embryos in any way or to create a chimera between humans and other animal species. New regulatory legislation is therefore called for and the report proposes that such new legislation should be based on the UK type administrative regulations and examination system for licensing and should impose a criminal punishment on an especially material violation.
In summary, with special regard to (ii) permissibility of and legal regulations to be imposed on studies using fertilized eggs or early embryos as well as application of reproductive medical technology (e.g. surrogacy), the reports evaluate the legal system in foreign countries, i.e. the UK and Germany, and compare the two countries: in Germany, all uses of embryos and all studies of embryos are prohibited, whereas in the UK, certain studies using embryos can be authorized. Some of the reports prefers the direction toward the UK type regulatory system, i.e. granting licenses to certain types of studies, when considering the nature of the Japanese Penal Code, i.e. intentions of imposing regulations that are not too restricted and of waiting for the final action, and also in view of academic freedom as guaranteed by the Constitution of Japan. The other issues require resolution by new legislation.
(4) Viewpoint of Medical Affairs Law
The following books address reproductive medicine from the viewpoint of medical affairs law.
<1> Hiroshi Ohtani "Medical practices and laws (new version)"
<2> Tetsu Ueki, editor "Textbook on medical affairs law" (with special regard to "Chapter 6: Advanced medicine and brain death")
<3> Masayoshi Ohno, editor "Modern medicine and medical affairs law system" (already described in (3))
From the viewpoint of medical affairs law, proposals are made under an independent legal system, which is separate from the Constitution or the Penal code. Here, the authors would like to introduce these proposals in accordance with the book by Ohtani <1> which discusses the latest reproductive medical technology.
From the viewpoint of medical affairs law, generally, a medical act will be legal only after the act satisfies the following 3 conditions: (1) a medical act will be associated with hazards to the individual's mental and/or physical aspects and therefore, shall only be allowable when it is necessary and useful to maintain or improve health, i.e. the issue of medical applicability; (2) a medical act shall only be performed by medically established methods, i.e. the issue of validity of medical technology; and (3) a medical act will be associated with invasion into the individual's mental and physical aspects and therefore, the patient concerned shall decide if he/she will accept it or not, i.e. the issue of the patient's right of autonomy. A therapeutic act by a medical doctor will not be legal unless it satisfies all 3 requirements.
From the above-described point of view, reproductive technology regarding artificial insemination and in vitro fertilization as a critical medical case is evaluated for medical applicability and for legal acceptability, which results in the conclusion that these reproductive technologies may be medically applicable since they are necessary to remove mental pain due to lack of capability of having a child and therefore, that it is difficult to control these reproductive technologies according to the currently effective laws. In connection with in vitro fertilization, how to handle a fertilized egg which is not implanted into the uterus of the woman is controversial: some claim the necessity of some legal regulations to be imposed on such handling, whereas others argue that there are no reasons for legal protection of such an embryo itself since it is before implantation.
Regarding whether some legal regulations must be imposed on reproductive medicine or not, ethical discomfort or vague anxiety is not sufficient for discussing this issue and instead it is necessary to define whose benefits will be lost by the medical treatment concerned and to identify the details of the benefits. At the same time, flexibility should be maintained in considering which legal regulations are necessary when it is evident that the medical treatment concerned will cause the loss of someone's benefits. Regarding cloned babies, for example, assuming that the dignity of the cloned baby as the individual is respected, then there are no legal reasons for opposing cloned babies. Considering the fact that society is never absolutely right nor perfect in relation to its utilization of results of new technology, it is the opinion of the authors of this book that we should be careful in imposing any legal framework to studies of life sciences and development of medical technology.
(5) Others
There are additional reports published which address this matter from the viewpoint of law: some focus on several law fields and others, on legal systems regarding reproductive science and technology in foreign countries. (The reports regarding overseas legal systems have been introduced in Section 2.2.)
<1> Kiyoko Kinjo "Reproduction related freedom and rights in the case of in vitro fertilization between non-spouses" Horitsu-no-Hiroba, April 1998 Issue
<2> Kiyoko Kinjo "Bioethics surrounding the start of life: Bioethics and Laws"