6C: Conclusions Regarding Grounds for Regulation
1. Examination of the Other Grounds for Regulation
(1) Human Dignity
Article 13 of the Constitution of Japan stipulates as follows: "All of the people shall be respected as individuals. Their right to life, liberty, and the pursuit of happiness shall, to the extent that it does not interfere with the public welfare, be the supreme consideration in legislation and in other governmental affairs." The expression "respecting of the individual" in this Article is also referred to as "the dignity of the individual" or "human dignity" and is interpreted to constitute the base of human rights or the fundamental idea of human rights. It is controversial, however, if this provision is interpreted to cover specific rights (i.e. the fundamental human rights prescribed by the Constitution) or not. Regarding the right of own portraits, the Supreme Court adjudicated as follows: "It should be understood that every person has freedom of not being photographed for his/her looks or figure without giving his/her consent to do so. Whether this is called the right of portraits or not is another issue. However, at least an act by a policeman of taking pictures of individuals' looks, etc. without any justified reasons is contrary to the philosophy prescribed in Article 13 of the Constitution and therefore will not be acceptable (Supreme Court Judgment, December 24, 1969)." This judgment indicates a negative action toward creation of new rights but makes it possible to give protection directly based on the provisions of this Article.
Euthanasia and death with dignity are the issues involved in life sciences that are related to the "respect for the individual" prescribed in the Constitution. There is a view that "when it is impossible for a patient to recover from disease and the patient has suffered from severe pain, his/her "refusal to receive any treatment merely to prolong his/her life" can be acceptable if the patient him/herself expresses evidently the will to do so" (refer to a book "Constitution" authored by Koji Sato and other literature). In this view, the term "death with dignity" is used but not many scholars supporting this view focus on the individual's dignity or the human dignity as the direct ground for the acceptance. They instead understand the patient's will as the right of autonomy regarding how to handle his/her own life and body and argue that this autonomy is guaranteed by Article 13 of the Constitution.
As specific rights related to the provisions of Article 13 of the Constitution, rights involving the personality such as the right of one's portrait and the right of privacy as well as the right of autonomy are generally considered. The right of autonomy means the right, according to which the individual is entitled to decide on his/her own regarding certain personal affairs, without suffering from any intervention caused by exercise of public power (refer to the book mentioned above by Sato). It is understood that the right of autonomy involves matters regarding how to treat one's own life and body, as described above, matters related to formation and maintenance of family such as marriage and divorce, matters related to reproduction such as contraception and artificial abortion, and clothing/appearance (refer to "Development of Science and Technology, and the Right of Autonomy" Hogaku-Kyoshitsu No. 212).
Many technologies in the field of life sciences involve human dignity, e.g. artificial abortion, artificial insemination, in vitro fertilization, surrogacy, pre-birth diagnosis, intentional selection of having a baby boy or girl, gene therapy, gene diagnosis, and human genome analysis. Of these technologies, only human genome analysis is a technology for which necessity of regulation should be investigated from the viewpoint of respect for the individual, i.e. the right of autonomy. The other technologies starting with artificial abortion can be regarded as those supporting the woman's right of having or not having a baby (as the right of autonomy).
When considering possible application of Article 13 of the Constitution to creation of a cloned baby, we can look at this issue on the side of the donor of a nucleus who may be entitled to exercise the right of autonomy regarding how to treat his/her own body and reproduction. The point in this consideration is the details of reasons because of which restriction is to be imposed on the right of autonomy that the donor of a nucleus would have. Since Article 13 of the Constitution prescribes that "Their right to life, liberty, and the pursuit of happiness shall, to the extent that it dose not interfere with the public welfare, be the supreme consideration in legislation and in other governmental affairs," the right of creating a cloned baby that the donor of a nucleus would have (note that whether this can be regarded as a right or not is another issue) will be limited since it is contrary to the public welfare. Although several categories in the public welfare may restrict the right of autonomy, there are two key points requiring particular attention: <1> conflict with the dignity of the child as an individual who is to be born (e.g. the right of pursuing happiness) and <2> opposition against the public order such as public policy or good morals. As a result of taking these points into account, the right of autonomy regarding creation of cloned babies is to be restricted. When considering the point <1>, i.e. the right of the child who is to be born, the following issues may be addressed: <a> whether the child who is to be born in the future, can be regarded as the subject who exercise the individual's rights or not; and <b> comparison of the two rights, i.e. the right of creating a cloned baby that the donor of a nucleus would have and the right of a cloned child who is to be born, would surely make the former inferior to the latter or not. (The authors will later discuss point <2>.)
For the issue <a> in the previous paragraph, the right of autonomy that the child who may be born would have regarding the way of living his/her life has not yet been the focus of discussion in the filed of constitutional law studies. On the other hand, the child who will be born cannot make any such decision that it would be better if the birth did not take place, since such decision denies him/herself. We have to pay attention to the possibility that ultimately, the argument around point <a> may come back to the third individual's evaluation that for specific children, individual would be happier to prevent them from being born. The issue <b> in the previous paragraph, i.e. comparison of weights between the two rights, is extremely difficult to address as indicated by the conflict between the right of a fetus with hereditary disease to be born and the right of his/her mother to undergo artificial abortion (i.e. the right of having or not having a baby).
Regarding "human dignity," it is possible to separate it from the interpretation of Article 13 of the Constitution and to acknowledge it as the universal ethical principle to humankind. This acknowledgment is more appropriate to understand the ethical issues related to reproductive medical technology in Europe. When European countries regulate reproductive medical technology, they invoke the principles of respecting human dignity and at the same time, they introduce the principles of protecting embryos and respecting human body in a specific manner, which will be discussed in a later paragraph.
The authors attempt to consider if there is any legal concept involving "human dignity" and "the individual's dignity" in Japan, other than the philosophy prescribed in Article 13 of the Constitution. The Civil Code prohibits consanguineous marriage and prescribes the following elements required for marriage: "Marriage between persons of lineal kinship or relatives by affinity up to the third degree of relationship in the case of collateral kinship shall not be allowed" (Article 734-1); "Marriage between persons of the matrimonial relationship shall not be allowed" (Article 735). These elements may be introduced from the concept close to the above-described philosophy related to "human dignity." In the field of civil code studies, it is understood that consanguineous marriage is prohibited for not only eugenic reasons, e.g. for the purpose of preventing hereditary diseases caused by consanguineous conception, but also the following reasons: because it is "contrary to morality and human feelings" (refer to "Family Laws and Inheritance Laws" authored by Ryo Ariizumi); and because "social and ethical considerations" are given (refer to "New Version: Comments to the Civil Code" authored by Masakazu Ueno). These additional reasons may be included in the wider concept of public policy or good morals and therefore are considered to represent point <2> described in the paragraph above: the right of autonomy for marriage is restricted when it is contrary to the public order.
Some academic views point out the problem of prohibiting consanguineous marriage between relatives by blood for the sole reason of a risk that the quantities of genes to be shared may be substantial, even if eugenic considerations are given to this matter, and criticize the necessity of maintaining the elements related to prohibition of marriage between persons of the matrimonial relationship since postwar Japanese society has been shifting toward the nuclear family, which typically consists of married couples with or without their children (refer to "New Version: Comments to the Civil Code"). As such, prohibition from the viewpoints of morality and human feelings or from the social ethical points of view are based on the relative standards of the society and therefore, influences caused by violation of such prohibition may be diverse. Just for the reader's information, if violation of the rules regarding consanguineous marriage should occur, such violation will not invalid the marriage concerned but constitute the reason for cancellation, and accordingly, there is no criminal punishment applicable to such violation. No such punishment is applicable to common-law marriage (factual marriage), either.
(2) Beginning of Human Life at the Time of Fertilization (at the Stage of Embryo)
There is no established theory regarding when a human life begins, although this issue has been discussed in many fields including biology, ethics, religion and philosophy. When looking at the Japanese laws, the Civil Code prescribes that "The enjoyment of private rights commences at birth (Article 1-3)," according to which it is interpreted that when the whole body of a fetus is exposed out of the mother's womb, his/her human life begins. Application of some of the Inheritance Laws indicate that "in connection with inheritance, a fetus is regarded as a baby which has already been born (Article 886-1)." The Penal Code prescribes that according to precedent cases, the crime of murder is applicable when part of the fetal body is exposed. In addition, the Penal Code prescribes the crime of artificial abortion (prescribed in Articles 212-216 of the Penal Code) in order to protect fetuses. Basically, when the body of a fetus, either as a whole or in part, is exposed out of the mother's womb, the fetus is regarded as a human individual. Although these provisions give some protection to fetuses, there is no established view regarding how to treat a fetus as the subject that is entitled to have the human rights. The Civil Code stipulates that "The provisions prescribed in the previous paragraph will not apply to a stillborn baby (Article 886-2)." The Penal Code prescribes the crime of artificial abortion, whereas the Mother's Body Protection Act (the old Eugenic Protection Law) prescribes that when it is judged that continuation of pregnancy may awfully damage the mother's health for physical or economic reasons, artificial abortion can be performed after obtaining consent from the mother herself and her spouse. From the legal point of view, no concept of a fetus is established. Usually, it is understood that fertilization brings about the formation of an embryo, which undergoes division and is simultaneously implanted in the uterus to form a morula and subsequently, develops into a fetus.
As discussed already, the Embryo Protection Act in Germany imposes regulations primarily on embryos: it prohibits abuse of embryos which have already existed under the natural process and also prohibits artificial creation of embryos. It is recognized that these views supporting the prohibition reflect ones of the Roman Catholic Church. "The Gospel of Life" in the well-known Encyclical Letter entitled "On the Value and Inviolability of Human Life" issued by the Pope John Paul II in 1995 states that "Right from fertilization the adventure of a human life begins. Christian Tradition is clear and unanimous in describing abortion as a particularly grave moral disorder, and the more recent Papal Magisterium has vigorously reaffirmed this common doctrine. In this doctrine, it is declared that abortion always constitutes a grave moral disorder since it is the deliberate killing of an innocent human being." "Moral evaluation of abortion also applies to intervention in a human embryo which becomes increasingly widespread in research fields of life sciences. Using human embryos or fetuses as subjects of experiments constitutes a crime of violating the dignity of their existence as human beings. Utilization for experimental purposes of embryos or fetuses provided by in vitro fertilization will never be permissible even if such utilization is intended to help the others." (quoted from the outlined summary of Encyclical in "Limits to Autonomy" in "Theory of Law: 17" authored by Etsuko Akiba)
These views are ethical and religious briefs and thus we cannot discuss whether they are appropriate or not. However, as the statements in "The Gospel of Life" clearly indicate, these views are based on the concept that a life begins at the moment when the ovum is fertilized, which inevitably leads to protection of embryos. The prohibition of abusing embryos is inseparable from the prohibition of abortion. It is a matter of course that unless justification of artificial abortion is investigated, the legal position of the embryo cannot be accepted. It seems to be difficult to legitimatize artificial abortion and to give reasonable explanations about prohibition of studies using embryos on the basis of the above described reasons, as performed in Japan. The research result report entitled "Legal Problems Surrounding the Right of Personality in Reproductive Medicine," the report of the research project concerning legal problems related to reproductive medical technology that was supported by subsidies for scientific research in the year 1993, made the following statements in their recommendations: "Reference to the cases in foreign countries, together with our investigation, made us consider it difficult to attempt at making a positive definition of the legal position of an embryo from the legislative point of view, and revealed a possibility that sticking to this attempt too much may put problem solving away. In the present recommendations, we therefore reached the minimum necessary agreement that the issue of defining the legal position of the embryo is to be avoided, while trying to be consistent with the existing laws." There may exist many difficulties in claiming that protection of an embryo is a legally protected interest.
(3) Respect for the Human Body
In France, the Civil Code expressly stipulates "the principles of respecting the human body": "The present Act shall secure the superiority of the individual, prohibit all invasions of the dignity of the individual, and secure respect for the individual from the very beginning of life (Article 16)." On the basis of these principles, the Civil Code prescribes as follows: <1> every individual shall have the rights according to which his/her own human body is given respect; <2> the human body shall be inviolable; and <3> the human body as well as the elements constituting the human body and the products of the human body shall not be treated as the subject of property rights. The Civil Code accepts the right of claiming injunction regarding the respect for the human body (Article 16-2) and stipulates that violation of the integrity of the human body shall only be permitted if such violation is necessary to administer therapy for the same individual concerned (Article 16-3).
The Civil Code in France, as a result of respecting the human body, prohibits adding any proprietary value to the human body (Article 16-5), confirms the principles of gratuitous donation of a human body (Article 16-6), reaffirms the principles of anonymous donation of a human body (Article 16-8), and prescribes that no surrogacy agreements shall be effective (Article 16-7). It further prohibits eugenic acts for the purpose of obtaining profit and changing genetic characteristics leading to any change in descendants of humans, for the purpose of protecting the integrity of human kind (Article 16-4).
The Bioethics Act in France is characterized by the provisions of extremely systematic protection to the human body as described above. The Constitutional Council in France made its judgment that the Act is constitutional. The grounds for this judgment of constitutionality for each of the above described provisions of the Bioethics Act were the Preamble to the Fourth Republic Constitution in 1946, Articles 1, 2 and 4 in the Declaration of Human Rights of the French Revolution, and Paragraphs 10 and 11 of the Preamble to the above mentioned Constitution.
Specific actions to be taken in connection with implementation of the Bioethics Act are defined in detail by the Public Health Code, the enforcement ordinances, and any other relevant regulations. For example, regarding removal, storage and use of tissues, cells and products derived from the human body, specific categories are defined, e.g. those outside the scope of regulation, those to which special rules are applicable, and those which should follow the general rules, and the regulation appears to be mostly reasonable (refer to "Summary of French legislation leading to the Bioethics Act" authored by Ichiro Kitamura, Jurisuto No. 1090).
However, in Japan, the currently effective legal systems on the private laws are built upon the basis that there exist the subject (human) and the object (thing) for the rights, and accept as a rule the absolute right to control things. Under these legal systems, if one attempts to treat the human body in a special way, then extremely careful considerations are required. As indicated by what France did, it would be required to make drastic changes in the currently effective Japanese legal systems as a whole which are centered on the Japanese Civil Code. Accordingly, we may have to be ready to accept substantial review of the legal system if we try to define any legally protected interest or benefit for the human body and to establish laws in order to regulate related matters.
2. Positive Benefits Obtained from Application of Cloning Technology
Cloning technology is not to be considered as an 'evil' technology and as previously discussed, application of cloning technology may bring about many things useful for promoting the happiness of humankind in the future. For example, <1> it is not only indicated for the treatment of infertility but also contributes to improvement of future medical technologies, such as clarification of cancer development and advancement of regenerative medicine (e.g. artificial organs causing no rejection); and <2> it may facilitate accumulating knowledge which can be utilized if unforeseeable situation in the future should occur (e.g. it may function as a back-up if we face a crisis to the future of humankind's reproduction, as pointed out by the discussion related to endocrine disturbing chemicals, i.e. so-called hormone-disrupting substances). There are additional points: <3> since scientific wisdom, supported by researchers' curiosity and autonomous activities, has brought about the creation of magnificent systems for science and technology, it is therefore feared that introduction of inappropriate limitations, even in part, may result in withering or declining of research. <4> The right of autonomy in the medical care field has caused substantial changes recently in European and North American countries in particular, the flow of which has brought about the concepts of artificial abortion, informed consent, and death with dignity. We cannot say that the right of autonomy is almighty, but under these recent trends noted in medical policies, it is highly likely that many reproductive medical technologies may be regarded as a form of exercising the autonomy right (which corresponds to "the respect for the individual" prescribed in the constitution). The authors therefore consider it desirable to evaluate relative advantages and disadvantages of the above-described various points in order to determine an appropriate form of regulation.
3. Summary
Academic councils organized by the national government have also begun to investigate regulation regarding application of cloning technology, and some reports are already published. These reports individually analyzed problems pertaining to cloning technology.
The Bioscience Group, Subcommittee for Promotion of Research in Specific Fields, Academic Examination Committee issued a report entitled "Research on Cloning at Universities, etc." on July 3, 1998. This report listed the following two problems related to cloning technology: <1> a concern that cloning technology may have undesirable effects on the genetic characteristics of the cloned baby to be born; and <2> a concern that cloning technology may have undesirable effects on the way that the individual, the family, and the society should be. This report also pointed out the following matters to which special considerations should be given: research on cloning may cause new arguments regarding the parents' right of decision-making on their child or the individual's independence, and eugenic ideas may be abused. In addition, this report focused on the fact that there exist social anxiety about or misunderstanding of cloning technology, and emphasized the necessity of taking appropriate action to cope with this current situation. Regarding whether cloning technology is ethically acceptable or not, this report indicated that there are both points for and against the technology.
The Clone Subcommittee, Bioethics Committee, Council for Science and Technology issued an interim report entitled "Basic Ideas on Cloning Technology" on June 15, 1998. This report addressed two major issues.
<1> Securing the human dignity: violation of the right according to which the individual is given respect; and deviation from the social recognition regarding the way human's reproduction should be.
<2> Safety-related problems: disorders of a newborn baby or occurrence of disturbance during the growth process.
European and North American countries impose individual regulations on reproductive technology from their own viewpoints. The outcome of these regulations are similar among the countries. However, these regulations are not always based on the idea that a human's life is begun from the stage of an embryo. It is not always true, either, that the inseparability of the human body is becoming accepted as a new principle of the civil code in all countries.
Nevertheless, regulation of cloning technology has been standardized from the global point of view, predominantly in Europe, in particular, and Japan needs to take some actions for regulating cloning technology. If this global standardization can be regarded as external unification regarding regulation, then it is desirable for Japan to explore its own grounds for justifying regulation while referring to the legal systems and supporting opinions to the legal systems in each of the countries.
In this section, the authors have focused on the following two points as the grounds for justifying regulation, for the reasons as described above.
<1> Safety
<2> Social order
These do not merely serve as the grounds for legislation but also deserve to be addressed aggressively by the national government as legislative policies, since the national government takes responsibilities for maintaining a lively and developing society.
When, on the basis of these legally protected interests and benefits, we evaluate the modality of regulation that has already been discussed in Section 5 entitled "Investigation of Subjects in Regulating Technology," we may consider that neither the safety nor social disorder related problems discussed above will occur for a moment if a series of events from implantation of a cloned embryo into the mother's womb, growth of the embryo into an fetus and to birth as a human individual will not occur. Accordingly, from the viewpoint of not only scope of regulation but also grounds for justifying regulation, the authors consider it favorable to investigate the way regulation should be in the two stages described below. We consider it proper to evaluate, as appropriate, methods of regulation, details of regulation, and measures to secure regulation according to the categories listed below.
<1> Core regulations (implantation of a cloned embryo into the mother's womb)
<2> Surrounding regulations (all other cloning-related research activities)