Section 3: Violation of Standards
1. Influence of Violation of Public Policy or Good Morals
The authors have so far discussed possible guidelines for medical practices from the viewpoint of public policy or good morals. We would like to summarize the discussion in this section. First of all, there are two issues to be addressed with regard to public policy or good morals discussed in Section 2-1 as described below.
(1) Is application of cloning technology contrary to public policy or good morals?
(2) If application of cloning technology is contrary to public policy or good morals, which actions could the administrative office then take to cope with this violation?
(1) We consider it difficult to make a comprehensive judgment regarding whether or not application of all cloning technologies is a violation of public policy or good morals since there exists extremely diverse modalities of their application. However, as discussed in Sections 5 and 6 of Part 1 of this Report, investigation of individual cases for determining if the legally protected interests are violated by a certain status of research reveals specific findings regarding the contents of the technology concerned, distinguishes between what is to be regulated and the act concerned, identifies which specific aspect of the legally protected interests is to be violated, and provides any other relevant information, then such information meets the minimum necessary conditions for the administrative office to make its own judgment, which may enable establishment of a certain standard for regulation. In other words, as in the case of the above-described guidelines for gene recombination experiments, such standard thus established may have some social and disciplinary effects.
Public policy or good morals represents the ethical consciousness in the society and should ultimately be based on the agreement among the ordinary citizen and be a generally accepted idea by the society. However, under the circumstances in which science and technology providing a basis of ethical consciousness in the society or generally accepted idea by the society is extremely advanced and specialized and in addition, such science and technology itself is progressing, it is difficult or even impossible for the ordinary citizen to draw a definitive conclusion and foresee any accompanying effect. As such, if no agreement of the ordinary citizen is achieved or no common idea is born without any actions taken by anybody, then it is expected that scientific associations, an assembly of researchers, or the State that is responsible for administrative matters would take an initiative to formulate standards (guidelines) in such a manner as deemed acceptable by the society.
From the above-stated viewpoints, it is desirable that guidelines be formulated on the basis of opinions from relevant individuals involved in a variety of related areas through open hearing procedures, especially after due consultation with those who might be both advantaged and disadvantaged or damaged by such guidelines, by the authorities that will take ultimate responsibilities. Guidelines shall never be based on any arbitrary investigation. Accordingly, it is desirable that such guidelines be not those formulated by scientific associations which primarily outline and summarize opinions from specialists in areas of science and technology but those issued by the State which represent opinions from those engaged in a wider range of areas.
If guidelines are investigated and formulated in the manner described above, we have no doubt that such guidelines would effectively function as social discipline. In other words, they could be used as an internal discipline of a scientific association, according to which violators may be expelled from the association, could provide a basis for administrative guidance by the administrative office, or could be used as the standards for statutory actions such as licensing by the administrative office. The previously introduced Bylaw issued by the municipal government of Suita City can be regarded as an example indicating that the social norms having the above-described character are used as a standard of a bylaw which has legal enforcement power.
If it is accepted that such guidelines provide sufficient norms for the ordinary citizen (with regard to formulating procedures, regulating intensity, procedures of making changes to cope with advancement in science and technology, etc.), then it may not be impossible to directly employ such guidelines as norms for administrative disposition or law suits. Regarding an entity who would ultimately make a principal judgment regarding whether guidelines functioning as social norms provide an immediate yardstick according to which a certain act is judged to be contrary to public policy or good morals, for example, the administrative office plays that role when an administrative disposition is performed on the basis of the Medical Practitioners Law, etc. and the Court plays that role when compensation for damages is claimed (note that regarding the former, the authors introduced the judgment by the Mito District Court, in Section 1, as an example indicating how the Court made its judgment regarding the disposition made by the administrative office regarding specialized technology).
The authors would like to give some supplementary explanation to emphasize that such guidelines, even when formulated by the State, do not have any legislative character, but should be regarded as accepted social norms since they are formulated by referring to opinions from specialized professionals and resulting from review of awareness about public policy or good morals in the society. When looking at the future ways the administrative authorities should behave, the necessity of such operations of providing public services which can only be performed by the State may be increased. As a matter of course, we may find any problems with incorporation of such guidelines, which are formulated in the manner described above, into laws or ordinances when they become enacted as a law.
(2) Assuming that application of cloning technology constitutes a violation of public policy or good morals and that there exist related licenses (e.g. by the Medical Service Law or the Radiation Hazards Prevention Act) or notices, what types of actions could be taken by the administrative office? First of all, the two actions described below can be considered when an act is contrary to public policy or good morals.
<1> The administrative office decides not to grant a license in response to an application made for license or decides not to accept a notice on the ground that the act concerned is contrary to public policy or good morals.
<2> The administrative office decides to grant a license or accepts a notice on the ground that a violation of public policy or good morals is not a criterion for licensing nor a formal requisite of the notice concerned.
In response to the decision in the case of <1>, if the person who made the application for license or prepared the notice filed a motion to the Court that the decision of non-licensing should be canceled or the notice should be accepted and the Court accepted the motion, then the Court would accept that the act contrary to public policy or good morals was valid and assist the realization of the act contrary to public policy or good morals, which is unjust (note that some argue that in a law suit filed against the administrative office, the claim by the person who made the application or prepared the notice may be accepted, but in a case where the person who made the application or prepared the notice are those who are directly involved in the act contrary to public policy or good morals, the juristic act of the person who made the application or prepared the notice may be judged invalid, although this argument may merely complicate the case). The above-described concept is found in the case regarding the Family Registration Law, i.e. the "Akuma-chan" case in which it was judged that the person who submitted the notice abused his right of naming his child and the notice concerned was not accepted.
Against the license or the notification in the case of <2>, if someone tries to file a motion of complaint or file an administrative law suit, the competency of the individual(s) concerned or the area within which the administrative office is allowed to exercise its discretion would be an issue. In any case, it is required to make a judgment on a case-by-case basis. On the other hand, those who directly involve the act contrary to public policy or good morals could file a civil law suit against the person who was given the license or who submitted the notice to confirm that their juristic act is invalid and to call for injunction against the violating act. In this sense, a motion of complaint made against the administrative office or an administrative law suit may have no substantial significance.
In light of these points, the authors consider that if guidelines have criterion for disposition by the administrative office as indicated in <1> above and disposition is performed according to such criterion, then such guidelines may be actually effective even without having any legislative provisions.
2. Influence of Violation of Standards for Medical Care Acts
Next, the authors would like to see if cloning technology satisfies the criteria described in Section 2-2.
(1) Is cloning technology an act which is medically appropriate?
(2) Is cloning technology an act which is valid as a medical technology?
(1) The medical appropriateness is related to what objectives a certain medical care act is intended to achieve. Generally, the following are approved to have medical appropriateness: <1> treatment and improvement of disease; <2> prevention of disease; <3> correction of deformity; <4> delivery and medically required abortion; <5> studies using patients for therapeutic purpose; and <6> experiments contributing to advancements in medicine (refer to "Laws from the viewpoint of medical doctors" authored by Toyoharu Matsukura). Of course, subjects of medical care have changed over time. For example, it was once considered in the past, in accordance with the criteria above, that cosmetic surgery and sex-change operation did not have medical appropriateness. Among reproductive medical technologies, there still exist strong opinions raising doubts about artificial insemination, in vitro fertilization, and implantation of a fertilized egg in the womb of a surrogate mother. Considering the special character of medical care, medical doctors have more grave ethical responsibilities than professionals in other fields and the issues listed here are related to the ethical aspects involving medical doctors. However, the problems related to medical appropriateness should ultimately be resolved not from the viewpoints of medical ethics but from the legal and social viewpoints (refer to "Medical Care Acts and Laws (New Version)" authored by Minoru Ohtani). It was considered in the past that organ transplant did not have medical appropriateness. At present, however, legislation is put in place to support organ transplant, which is accepted as a medical care act. On the other hand, lobotomy was once used as a medical technology but its medical appropriateness is currently ruled out. At present, artificial insemination and in vitro fertilization between spouses are regarded as medical care actions complying with the announcements made by the Japanese Association of Gynecology and Obstetrics, whereas in vitro fertilization between non-spouses do not comply with them. We should be careful, however, in making an immediate judgment that this non-compliance indicates non-medical appropriateness of in vitro fertilization between non-spouses.
As previously described, artificial insemination and in vitro fertilization are measures to cope with infertility. On the other hand, creation of a cloned baby through the use of cloning technology does not result from fertilization and subsequent pregnancy process, which indicates evidently the remarkable heterogeneity of this technology. When creating a cloned baby, there is no fertilization between an egg and sperm. Creating cloned babies is therefore not an infertility therapy intended to eliminate obstacles in pregnancy. As cloning technology is understood as one of the technologies to develop new breeds of animals, improve the quality of animals, and increase the number of animals in the field of stock-breeding, cloning technology is an act of increasing individuals in number which is a totally new experience for humankind. We therefore can consider that cloning technology is totally different from medical care acts such as treatment of disease or correction of deformity.
Finally, the authors compare cloning technology with surrogacy, for which many individuals express a negative opinion against its appropriateness as a medical care act. We previously introduced the idea that surrogacy is contrary to public policy or good morals. A violation of public policy or good morals is the legal judgment. As in the case of narcotic drug use or the case where a Japanese gangster (yakuza) amputates the tip of a little finger either as a punishment or as a token of penitence, it is not undue that the medical care act concerned lacks medical appropriateness because it is contrary to public policy or good morals. As previously explained, surrogacy may confuse the social order but, on the other hand, the State can make its discretionary decision on surrogacy related matters. A new family relation created by cloning has no legal friction and will cause greater confusion. The idea that creation of a cloned baby is contrary to public policy or good morals is therefore not unreasonable, on the basis of the discussion made on surrogacy.
(2) Medical technology displays its effectiveness in many cases by invading in any way the body of the individual that undergoes the medical technology. When evaluating medical validity, the benefit and risk attributable to the invasion concerned should be compared in particular and a medical technology is valid only when the benefit outweighs the risk. This risk/benefit ratio is derived from medicine or medical ethics. It is understood, however, that drawing a standardized criterion is difficult in reality and legal evaluation is necessary to determine the validity of a medical technology to be approved (refer to the report above authored by Minoru Ohtani).
Regarding safety of cloning technology, the donor of a somatic nucleus has almost no risks and some risks are foreseeable in the donor of an egg and the women who receives implantation in her womb. Overwhelmingly greater risks and genetic effects are posed to children and descendants. On the other hand, only the donor of a somatic nucleus enjoys benefit. The usual forms of artificial insemination and in vitro fertilization have the same character of benefiting one-sidedly. When focusing on the beneficiary, an extreme one-sided benefit is noted in cloning technology as compared to artificial insemination or in vitro fertilization where at least the couple, both wife and husband, enjoy the benefit. When focusing on the risk, cloning technology has higher risk of causing greater genetic effects as compared to artificial insemination or in vitro fertilization where highly sensitive germ cells are used. From the viewpoint of safety, cloning technology greatly differs qualitatively from artificial insemination or in vitro fertilization.
(3) As discussed above, cloning technology has many problems in terms of appropriateness and validity. In any event, what is discussed here is that cloning technology is an act which is not medically appropriate nor valid. It may be necessary to make such judgment focusing on the character of a medical care act, in addition to a judgment focusing on the character of a science and technology. It may be required that this non-appropriateness and invalidity of cloning technology is confirmed by legislation. However, considering the fact that the medical affairs related laws have not defined any legal grounds for the level of medical care or the standards of operating medical care technology, if standards of medical care acts are established in a form of guidelines issued by a scientific association or by the State, then it may be highly likely that such guidelines can be used as a ground for non-licensing or punishment of an act according to the regulations of the currently effective Medical Practitioners Act, etc.