Section 2:Unwritten Legal Codes

1. Non-Licensing on the Ground of Violation of Public Policy or Good Morals, etc.

(1) Bars to Patentability According to the Patent Law: the Patent Law Expressly Bans Violation of Public Policy or Good Morals, etc.

The Patent Law prescribes bars to patentability as follows: "those which may damage the public order, good morals or public health" (Article 32-2). In Japan, since the establishment of "Patent Ordinance" in 1886, those which may disturb the order and good morals have consistently been barred to patentability. At present, the majority of the theories have no objections against the view that inventions which may damage the order or good morals should not be patented (refer to "Outline of the Patent Law: 8th version" authored by Kosaku Yoshifuji). Inventions which are contrary to public policy or good morals are defined as follows: <1> the original purpose of invention damages public policy or good morals (e.g. counterfeit money producing machine, opium inspirator); and <2> although the original purpose of invention may not damage public policy or good morals, owing to the purpose and elements of the invention concerned, anybody can easily find out a possibility of using it for an immoral purpose and in addition, such use is expected highly probably (according to precedent cases, libido-intensifying devices are included in this category <2> but bingo games are not). For example, any invented gene recombination technique producing microorganisms harmful to human bodies should be a bar to patentability according to the provision of the article described above.

Outside Japan, the Intellectual Property Right Code in France stipulates that "inventions, publication or embodiment of which is contrary to public policy and good morals" shall not be patented. The following form was added to this Code: "human bodies as well as their elements and products, and knowledge of human genes as a whole or in part cannot be a subject of patent." This is based on the philosophy in France that since acts of handling human bodies as goods are illegal, knowledge of gene sequence is regarded as common assets which the humankind share and therefore is made public, whereas in the US, the predominant idea was to try to obtain patents for every piece of knowledge obtained from analysis of gene sequence (refer to "Summary of French legislation leading to the Bioethics Act" authored by Ichiro Kitamura, Jurisuto No. 1090).

As illustrated above, the contents of public policy or good morals greatly differ among countries. In these countries, the provisions regarding public policy or good morals are expressly set forth in laws and they are treated as bars to patentability.

{Note} Regarding this matter, there is another view as follows: granting patent to an invention means only giving the exclusive right to the invention and does not mean that the invention will surely be put into practice; accordingly, granting patent does not always mean that practicing the patented invention is admitted; on the other hand, an invention which is not given patent can be practiced if such practice is not banned by the other laws or ordinances; and regarding the inventions included in the category <2> above, it is sufficient to regulate them by the other laws and ordinances according to the form of the invention concerned and the Patent Law should not intervene in them (refer to "Industrial Property Rights Act" authored by Nobuhiro Nakayama).

(2) Possibility of Non-Licensing by Laws and Ordinances which do not Expressly Prescribe Provisions Regarding Public Policy or Good Morals

In the case of general administrative laws, the authors will discuss if an application for license can be ruled out or not, or acceptance of a notice can be refused or not according to general clauses regarding public policy or good morals, etc. even though laws or ordinances do not expressly prescribe specific provisions unlike the Patent Law. The reasons why inventions contrary to public policy or good morals will not be patented according to the Patent Law are not based on industrial policies but considered as a matter of fact (refer to Nakayama's report above). It is not clear, however, if violation of public policy or good morals can be a bar to patentability if the Patent Law would not have no expressly prescribed provisions.

Precedent cases and academic views indicate the following reasons of law as sources of law in the case of unwritten laws: principles of equality, principles of proportion, principles of estoppel, principles of good faith, and principles of procedural justice (refer to "Summary discussion about administrative laws" authored by Naohiko Harada); and abuse of rights and principles of faith and sincerity (refer to "Basic matters regarding administrative laws" edited by Takenori Murakami). When reviewing precedent cases with special regard to invalidity of administrative acts, administrative acts were often judged to be invalid on the ground of the following defects, among the categories of defects of administrative acts: because the act(s) concerned abused rights (which is frequently noted in judgments made by the lower level of courts); and because the act(s) concerned violated the principles of good faith (which was the judgment made by the Supreme Court on August 17, 1965, although the principles of good faith were not expressed).

No academic views expressly accept public policy or good morals, however. When looking at precedent cases, we found the judgment that Article 90 of the Civil Code prescribes acts or legal relation from the viewpoint of private laws and has never been applied to procedures of buying out farmland, which is the effect of exercise of public power (made by the Tokyo High Courts on January 29, 1954). In these cases, administrative acts conducted on the side of the administrative office had reasons for blaming. These judgments are therefore not applicable to the issue of whether the administrative office can rule out an application for license or refuse a notice or not when the individual who has made the application or has submitted the notice has such reasons for which his/her acts should be blamed. That is why it is stated that the principles of equality, proportion and good faith play important roles as binding principles for the discretion that the administrative power has (refer to "Outline of administrative laws" authored by Toshio Fujii). On the other hand, unlawfulness in the State Redress Law is judged not only when the acts(s) concerned violate the legislative laws but also when the act(s) concerned is contrary to the reasons of law (e.g. public policy or good morals, principles of faith, and abuse of rights), although some interpret this matter in a narrow sense and others, in a wider sense (refer to "Administrative Laws (Revised version)" authored by Toshi Takada). Accordingly, there are no grounds indicating that the administrative laws exclude the idea employed by the Civil Code that maintenance of public policy or good morals, etc. is given the supreme importance from the viewpoint of laws and regulations, but instead we should interpret that laws will not help realization of an immoral act (note that it is stated in "New version: Administrative Laws" authored by Jiro Tanaka that "the reasons or law or logical sequences which indicate what things should be according to the sense of justice in the general society have significant meanings as the basic principles for interpretation of laws and also as complementary sources of laws if some defects are noted in laws"; Tanaka thus stated the existence of legal grounds and pointed out, as one of the grounds, "Rules for the Conduct of Trial" announced by the Cabinet in 1876).

{Note} "All legal relations should be governed by public policy or good morals. Public policy or good morals is regarded as the philosophy to govern the whole systems of laws. In other words, the idea that exercise of rights and fulfillment of duties should follow the principles of good faith, setting limits to self-help, and the fact that the reasons of law are used for interpretation of legal acts represent nothing but specific application of the philosophy of maintaining public order and good morals." (refer to "General Rules of the Civil Code" authored by Sakae Wagatsuma).

The authors would like to take the Family Registration Law as an example. Regarding a notice on the child's name, Article 50 of this Law only prescribes that "the Chinese characters that are in common use in Japan and that are easy to read shall be used for children's names" (Article 50-1) and "the scope of the Chinese characters that are in common use in Japan and that are easy to read shall be defined by relevant orders" (Article 50-2). We can interpret that these provisions have nothing to do with the meaning of the child's name. Concerning this interpretation, so-called "Akuma-chan" case occurred as described below.

In 1993, a person submitted to a city hall a notice stating that his child's name will be "Akuma (in Japanese which translates as "devil" in English)." The notice was accepted and this name was entered on his family register document. Following this, the city hall gave instructions to the person who filed the notice that since naming his baby "Akuma" was an abuse of the parent's right of naming their child and the child's name stated in the notice was inadequate, the person was requested to submit a different name. The city hall then decided to regard this baby's name as "not named yet," stated "not named yet" in the column of birth in the family register document, and eliminated the name "Akuma." The person who had filed the original notice was dissatisfied with this decision and filed a motion for complaint to the Family Courts. It is said that the city hall's decision was in accordance with the Response by the Civil Affairs Bureau, the Ministry of Justice (dated September 14, 1993). In response to the motion for complaint, the Family Courts decided as follows: when the right of naming the child is abused and such abuse is evidently unreasonable from the viewpoint of the generally accepted idea by the society, the city, town and village mayors are allowed to refuse the notice regarding the child's name concerned; this is applicable to the name of "Akuma"; however, since the notice was once accepted by the city hall, the rules that the city hall should observe are that they try to persuade the parents to make an application for correction of their family register document even if the name submitted violates the rules of the Family Registration Law; the city hall did not do this and eliminated one-sidedly the entry "Akuma" from the register document; and this elimination was illegal and accordingly, the entry "not named yet" should be eliminated (refer to "A child named "Akuma"" authored by Aiko Noda, Jurisuto No. 1042). The city hall was dissatisfied with this decision and immediately filed an appeal to the Court. However, the person who filed the original notice withdrew his motion for complaint and gave a different name to the child. The case thus ended.

The above-described case is not related to public policy or good morals but involved banning of abuse of rights. The point in this case is whether or not the administrative authorities can refuse acceptance of a notice on the basis of the idea employed by the Civil Code that banning of abuse of rights is given the supreme importance, even if the Family Registration Law, an administrative law, does not prescribe any relevant provisions. The side of the administrative authorities (which are, in this case above, the city hall and the Ministry of Justice) and the Court admitted that the name "Akuma" is evidently unreasonable from the viewpoint of the generally accepted idea by the society and accordingly, they were allowed to refuse acceptance of the notice concerned. Prior to the occurrence of this case, the circular concerning the Family Registration Law had been issued, which prescribes that when a notice on a name not conforming to the provisions of Article 50 of the Law is submitted, such notice should not be accepted. It is therefore considered that in the case above, the Court took a positive attitude toward abuse of the right of naming.

Article 37 of the Administrative Procedures Law established following the case above prescribes that "as far as a notice satisfies the following conditions: a documented notice has no inadequate entries; a documented notice contains required documents as attachment; and a documented notice meets the other requirements by laws and ordinances concerning the form of the notice, it shall be regarded that the procedural duty of completing the notice concerned is fulfilled at the time when the notice concerned is delivered to an office of an institution which is designated as the entity to which the notice concerned is submitted." In subsequent cases, the interpretation of the relevant articles of the Administrative Procedures Law may also be an issue to be addressed.

(3) Meaning of Public Policy or Good Morals

(i) Classification of public policy or good morals

Article 90 of the Civil Code stipulates "contra bonos mores" (violation of public policy or good morals). This Article and Article 1, which stipulates public welfare, banning abuse of rights and violation of the principles of good faith, are regarded as general clauses. Article 90 prescribes that a juristic act which is contrary to public policy or good morals shall be null and void and produces a wide range of legal effects: when a person causes damage to others because of his/her act is performed in such a manner as contrary to public policy or good morals, the act is regarded as a tort and the person shall be liable for compensation for damages; and when payment is contrary to public policy or good morals, the payment is illegal and no one shall be entitled to claim for return of unreasonable profits. The contents of this Article, like the other general clauses, represent extremely abstract concept, however. Accordingly, the idea of public policy or good morals should be determined by taking into account the customary practices of the society and the ethical thoughts of the relevant time.

{Note} When looking at foreign countries, Germany has a similar concept of public policy or good morals to Japan (although, there is no concept of public policy in Germany) and France has her own concept of public policy or good morals. Some of the political policies in France have recently been revised and the following revisions, among other, are made by legislation or courts' decision: life insurance shall be immoral and therefore null and void since it speculates on human life (by the Law in 1930); intermediation of marriage is immoral and contrary to public policy (by the judgment of the Court of Appeals in 1944); and transfer of customers between individuals who run their own business independently is contrary to vocational policy (by the judgment of the Court of Appeals In 1961).

It was considered at the beginning of legislation that public policy was different from good morals. At present, however, these two are considered as similar concepts having an identical objective, according to which the following seven categories of specific contra bonos mores (violation of public policy or good morals) were classified by Sakae Wagatsuma before the War on the basis of precedent cases are still now generally accepted: <1> those which are contrary to humanity or morality; <2> those which are contrary to the idea of justice; <3> acts which produce unreasonable profits or benefits by adversely utilizing another individual's unthoughtfulness and/or difficulties; <4> those which pose extreme restrictions to the individual's freedom; <5> limitation of freedom of business; <6> disposing property which is the base of living a life; and <7> those which are outstandingly speculative (refer to "General rules of the Civil Code" authored by Sakae Wagatsuma).

The classification of precedent cases by Wagatsuma focused on pre-war cases and it is extremely difficult to classify post-war precedent cases according to Wagatsuma's classification. Some claim that the contents of this classification have changed in character. In recent years, many proposals are made for new classifications in addition to Wagatsuma's classification. For example, one proposal is to classify legal interests that have been protected under Article 90 of the Civil Code, according to individual norms and orders as follows: <1> violation of the constitutional order; <2> violation of the order of laws and regulation under the public laws; <3> violation of the order under the trade laws; <4> violation of the order under the family laws; and <5> loss of legally protected interests which are under establishment. According to this new classification, the majority of the recent cases are included in the category of the violation of the order under trade laws, whereas there is a decreasing number of cases included in the category of the violation of the order under family laws. With special regard to "loss of legally protected interests which are under establishment," marriage between homosexuals, surrogacy, and selling & buying organs are included in this category, although no precedent cases in this category have yet occurred in Japan (refer to "Types of violation of the provision regarding public policy or good morals prescribed in Article 90 of the Civil Code" authored by Hiroki Nakaya, in a book "Study of violation of public policy or good morals" edited by Yoshio Tsubaki and Susumu Itoh). Matters regarded as ethical problems in the fields of life sciences and reproductive medical technology may mostly be included in this category of "loss of legally protected interests which are under establishment."

For relation between public policy or good morals and abuse of rights, both of which are regarded as general clauses, public policy or good morals are considered to be simple criteria for examination for abuse or rights or requirements for abuse of rights. On the other hand, public policy or good morals involve conclusion of a contract, i.e. a stage at which rights are generated, whereas abuse of rights involve exercise of the rights thus generated. When we follow this idea, the above-described abuse of the right of naming may be interpreted to be a violation of public policy or good morals if we focus on the name given to the baby. Recent academic views and precedent cases do not mention abuse of rights and this is because cases to which abuse of rights is applicable according to the conventional concept are handled by more specific and individual provisions owing to legislation and legal interpretation (refer to "Public policy or good morals and abuse of rights" introduced above).

(ii) Cases in which application of advanced science and technology to medical practices involves public policy or good morals

Both inside and outside Japan, there exist not many cases in which application of advanced medical technology is contrary to public policy or good morals. In France, the Court of Appeals adjudicated that an association to recruit and introduce surrogate mothers was null and void on the grounds of the laws or any other regulations according to which non-profiting associations are null and void if they are contrary to the public policy that the human status is inviolable and contrary to good morals (refer to "Public policy or good morals in precedent cases in France" authored by Joji Nanba introduced above). In Japan, some theories argue that surrogacy agreements are contrary to public policy or good morals and therefore null and void.

On the other hand, the Japanese Association of Gynecology and Obstetrics announced their opinions regarding in vitro fertilization and embryo transplantation (in October 1983), studies handling human sperm, ova and fertilized eggs (in March 1985), a system of registering and reporting clinical implementation of in vitro fertilization and embryo transplantation (in March 1986), selection of sperm (in August 1994), use of organs, etc. from dead fetuses or newborns in studies (January 1987), fetal diagnosis for any malformation (in January 1988), freezing/storing and transplanting human embryos and ova (in April 1988), clinical implementation of microscopic fertilization method (in January 1992), multiple pregnancy in the case of in vitro fertilization and embryo transplantation (in February 1996), artificial insemination between non-spouses and sperm donation (in May 1995), the range of clinical application of in vitro fertilization and embryo transplantation in humans (in October 1998), and pre-implantation diagnosis (in October 1988). The Association indicated their opinions that each of these medical practices should be performed under certain conditions. On the basis of these opinions, in vitro fertilization or embryo transplantation, for example, was performed in 17,992 women using fresh embryos, in 1,531 women by using frozen embryos, and in 6,559 women by microscopic fertilization (in the year of 1995 for each technology). We cannot deny the performance thus achieved. On the other hand, when application of reproductive technology is contrary to the conditions proposed in the announcements of the Japanese Association of Gynecology and Obstetrics, can we make an immediate judgment that such an act is contrary to public policy or good morals? This is a difficult issue.

Regarding cloning technology, the Japanese Association of Gynecology and Obstetrics stated in the announcement entitled "Opinion about in vitro fertilization and embryo transplantation" that "when implementing in vitro fertilization and embryo transplantation, gene manipulation shall not be performed." The announcement defines the "gene manipulation" here as artificial implementation of gene engineering, cloning, creation of heterogenous hybrids or chimeras, etc. and lists the following manipulations: biological manipulations such as viral implantation; physical manipulations such as irradiation and mechanical manipulations using micro-manipulators; and chemical manipulations such as administration of chemical substances which may affect humans. The Association stated in the announcement that these manipulations are contrary to the objectives of in vitro fertilization as medical practice and therefore are contrary to medical ethics.

2. Standards of the Duty of Care in Medical Care

(1) Relation between Medical Doctors and Researchers

The authors will discuss the relation between medical doctors and researchers by taking cloning technology as an example. As previously described, creation of a cloned baby requires removal of a human unfertilized egg or fertilized egg. According to the current technology, it is difficult to raise an ovum into which a human somatic nucleus is transplanted, outside the uterus. It is therefore necessary, when returning back the ovum into the womb for development and growth, to make a cloned embryo implanted in the uterus so that the embryo subsequently follows the same process as in the case of in vitro fertilization.

The Medical Practitioners Law prescribes that "nobody but those officially qualified as medical doctors shall practice medicine" (Article 17). The Law further prescribes that a person who violates this rule shall be punished with imprisonment for at least two years or with a fine of at least twenty thousand Japanese yen (\20,000). In this provision, practicing medicine is defined as performing medical acts continuously and repeatedly. The contents of medical acts are complicated and diverse, and also always change along with advancements of medicine. It is therefore difficult and inappropriate that laws define medical acts: the Medical Practitioners Law does not define medical acts. Under these circumstances, precedent cases and academic views indicate various ideas for the definition of medical acts. The idea generally accepted at present is "any act which may cause hazards to the human body if not performed under medical judgment and technology of medical doctors." Specifically, the following acts related to reproductions are regarded as the medical acts according to precedent cases: to a woman suffering from irregularity of menstruation, acts of hearing from her symptoms, making a diagnosis, and inserting a menstruation-inducing pill into the uterus by using uteroscope and forceps; and an act by a practitioner of moxibustion of inserting uteroscope into the uterus for internal examination. Academic views regard artificial insemination as a medical act (refer to "Medical Affairs Law" authored by Hiroshi Noda). The authors therefore consider that removal of unfertilized or fertilized eggs, introduction of cloned embryos into the uterus for implantation and any other necessary technologies for creation of cloned babies correspond to medical acts and nobody but medical doctors can perform these medical acts. The authors have regarded application of cloning technology as research and in this sense, the creation of a cloned baby (i.e. implantation of a cloned embryo into the mother's womb) that the authors has proposed to be regulated should be included in the category of core regulations in the previous section is advanced research activity and at the same time, is a medical act.

In reality, it is doubtful whether or not acts of transplanting a somatic nucleus to an unfertilized or fertilized egg and performing other similar levels of techniques required for creation of a cloned baby can be regarded as medical acts as far as these acts are performed for the sole purpose of research. We thus cannot deny the possibility that these acts may be performed by those other than medical doctors. However, some of the acts performed for the purpose of creating cloned babies cannot be nothing but medical acts and accordingly, medical doctors will take final responsibilities. As described in the previous section, it is possible to impose restrictions on creation of cloned babies only by regulating medical doctors even if there are no direct regulations on researchers, on whom it is difficult to impose regulations.

If a cloned egg grows in vitro, then of course it becomes necessary to impose direct regulations on researchers. However, considering the currently available technology level, we cannot foresee such possibility for a while.

(2) Restrictions on Medical Care Acts

The medical care act is an invasive act to a human body in nature. When individuals other than medical doctors perform medical care acts for purposes other than medical care, such conduct will constitute a criminal bodily injury according to the Penal Code and the person concerned will not escape liability for a tort according to the Civil Code. As far as medical doctors perform the medical care act that should be performed by medical doctors, those medical care acts are justifiable acts and illegality is excluded. In this section, the authors will make general investigation regarding to what extent medical care acts are regarded as legal causes of exemption of illegality, not getting into specific investigation regarding individual responsibilities such as criminal liability, civil liability and further, administrative liability according to the Medical Practitioners Law, etc.

A medical care act is required to satisfy the following three criteria in order to be regarded as a justifiable act: <1> an act which is medically appropriate; <2> an act which is valid as a medical technology; and <3> a patient has given his/her consent. When a medical act does not satisfy one of the three criteria, there may be no legal ground of exemption of illegality for that act. The authors will focus on criteria <1> and <2> in this section.

Acts having medical appropriateness are defined as those which are appropriate, from the objective viewpoint, for saving a patient's life and maintaining and promoting a patient's health, and which are valid when implementation of these acts is required. In this sense, cosmetic surgery, consented injury, eugenic surgery, sex-change operation, surgery for intentional artificial abortion, etc. become problematic. In the field of reproductive medical technology, artificial insemination and in vitro fertilization may also be problematic according to this definition. Regarding the validity of medical care technology, medical examinations which do not achieve the level of available medical care that the authors will describe later, experiments on live human bodies, and clinical studies for investigational purposes may cause problems in relation to this definition.

The contents of individual acts, however, are extremely affected by changes over time in the social conditions. For example, the medical affairs related law prescribes the requirements for obtaining certificate of medical doctors, etc., the duties of medical doctors, the standards of medical institutions, but contains an extremely small number of provisions pertaining to the details of medical care acts. Accordingly, medical doctors are allowed to have a greatly wide range for exercising their own discretion regarding medical care acts. This is because the administrative office has assumed the policy of not as a rule being involved in the details of medical care and health care related instructions and of allowing medical doctors, etc., who have acquired expertise and skills in medical care, to freely make their own judgment regarding these matters since medical care is a highly specialized area (refer to "Medical Affairs Law" authored by Hiroshi Noda). The major reasons why medical doctors are allowed to exercise their own discretion in this wide area are described below (refer to "Medical Care Acts and Laws (New Version)" authored by Ohtani):

(i) Since a pathological change, i.e. a lesion, is determined by a patient's own physical conditions and is affected by environmental conditions under which the patient exists, application of medical technology which is approved from the viewpoint of medicine will differ among individual patients and thus will be individualized.

(ii) In order for a therapeutic act by a medical doctor to produce benefit to the patient concerned, the medical doctor is allowed to be free to make full use of his/her academic learning, skills and experience.

The authors will review these requirements later in a specific manner. In any way, if it is judged from the viewpoints of medical acts described above that cloning technology lacks medical validity and appropriateness, then the act of performing cloning technology cannot be regarded as a justifiable medical act and is therefore an illegal act, without having any specific laws established regarding this technology.

Considering the characteristics of medical practice, the Japanese national government has avoided policies of imposing direct regulations on the contents of medical care by legislation. The Medical Practitioners Law was amended in 1949 and Article 24-2 of the amended Law prescribes that "when the Minister for Health and Welfare judges it necessary, in a case in which material harms to public health may be caused, to give relevant directions regarding medical care and health care related instructions, to the medical doctors in order to prevent such harm, the Minister for Health and Welfare shall be entitled to do so (Article 24-2-1)," and that "the Minister for Health and Welfare shall, when giving directions under the aforementioned provisions, consult with the Medical Ethics Council (Article 24-2-2)." The right that the Minister for Health and Welfare has for giving instructions is thus prescribed and he/she is entitled to exercise this right after consulting with the Medical Ethics Council. According to these provisions, the "Standards that Medical Doctors and Dentists shall Follow regarding Blood Transfusion" was already announced (Announcement by the Ministry of Health and Welfare in 1952). In addition, many administrative Circulars regarding the contents of medical care were issued, although the issuance of these Circulars was not directly related to the right to directions described above (refer to "Medical Affairs Law" authored by Hiroshi Noda). These Circulars may at least be based on the provisions of the Article introduced above.

Some claim that directions given by the Minister for Health and Welfare have no legal binding power but are merely regarded as instructions, while the others argue that the directions have a norm-like binding power. When reviewing judgments made at the lower level of courts, many of them follow the former theory.

{Note} The case that triggered the amendment of this law was as follows: blood taken from a donor infected with syphilis who was paid remuneration was transfused to a patient who subsequently contracted syphilis. The Supreme Court admitted negligence of the medical doctor concerned and adjudicated as follows: if the medical doctor had conducted reasonable medical interview, the medical doctor should have been able to foresee the occurrence of the results; the individuals who are engaged in professions involved in the management of life and health of humans (i.e. medical practices) shall have the obligation of taking the best care necessary from the experimental viewpoint to prevent risks, according to the nature of the profession concerned."

(3) Appropriateness of Medical Acts

Unlike discussions regarding the validity of medical care acts and the level of available medical care which the authors will describe later, discussions regarding the medical appropriateness of medical care acts are frequently related to the issue of public policy or good morals. We will investigate them by introducing specific cases.

(A) Cosmetic Surgery

The medical act should have the objective of eliminating harms caused by a disease and in addition, the elimination should overweigh the medical act which is an invasive act. Cosmetic surgery does not have this objective and it is therefore interpreted that cosmetic surgery is not a medical care act. The common view in the field of criminal laws follows this interpretation and indicates a negative stand to the opinion that cosmetic surgery is a medical care act (although it is explained that since a victim has given his/her consent, elements constituting a crime are incomplete or illegality is escaped). In the field of civil law, it is generally understood that cosmetic surgery is application of specialized medical technology and has nothing different from the usual medical examination. There is a precedent case, although made by a lower level of court: "eliminating mental dissatisfaction, e.g. admiration for beauty and worry about poor-looks, is also accepted as a positive objective" (Tokyo District Court on May 1, 1972). Subsequently, the Medical Service Law was amended and to the amendment, cosmetic surgery was added as a new department of medical examination. Cosmetic surgery is thus officially approved legally, although it is said that cosmetic surgery is still treated slightly differently from ordinary medical care.

(B) Consented Injury

As far as consented injury is not contrary to public policy or good morals nor social reasonableness, the injury is not regarded as a criminal bodily injury and not punished. There is an opinion that although no one is entitled to decide how to treat another's life, it is considered that every person has the right of making their own decision regarding how to treat his/her own body and this right of treating their own body can be exercised by the person that owns the body concerned: a person who tattoos on the body of a Japanese gangster (yakuza) or who helps a yakuza amputate the tip of a little finger either as a punishment or as a token of penitence is not punished (refer to "Medical Care Acts and Laws (New Version)" authored by Ohtani).

(C) Intentional Artificial Abortion

The Mother's Body Protection Act (and also the old Eugenic Protection Law) prescribes that when it is judged that continuation of pregnancy or delivery may awfully damage the mother's health for physical or economic reasons, a medical doctor is allowed to perform artificial abortion after obtaining consent from the mother herself and her spouse. The true aim of this provision is that intentional abortion performed from the social viewpoints shall only be accepted when continuation of pregnancy or delivery may gravely damage the mother's health. In reality, however, "it is impossible for medical doctors to investigate or confirm how the mother's health is affected by economic reasons, and medical doctors do not have such obligation. We can see that social political views are directly incorporated in the medical appropriateness of artificial abortion. An attending medical doctor can make his/her own judgment regarding whether an operation for intentional artificial abortion is reasonable or not and the legal regulation on artificial abortion has no substantial significance. The provisions regarding artificial abortion by the Penal Code are therefore meaningless" (refer to "Medical Care Acts and Laws (New Version)" authored by Ohtani).

(4) Level of Available Medical Care

The authors do not consider it necessary to discuss the validity of medical care in detail here and will only discuss the level of available medical care. In the medical affairs law, responsibilities of medical doctors (responsibilities of fulfilling obligation and not conducting torts) on the basis of accidents caused by malpractice are investigated and the idea of "level of available medical care" is employed as the medical doctor's duty of care: medical doctors have the duty of performing medical examination and therapy within the level of currently available medical care; and even if a medical doctor did not perform medical examination and therapy beyond the level of currently available medical care, he/she will not be liable for non-fulfillment of obligation nor a tort.

There are two specific levels of available medical care: "level of medicine as a study (i.e. the level of fundamental studies which are under progress with the objective that results of such studies will be standardized)" and "level of practical medical care (i.e. the current objectives to be achieved by medical care which is already standardized among professional health care individuals)." The level of available medical care employed by the medical affairs law is the latter one (refer to "Between Medicine and Laws" authored by Toyoharu Matsukura; and the judgment made by the Supreme Court on March 30, 1982). This level of available medical care is general and objective. Differences of medical care among hospitals are related to the actual state or circumstances and do not affect the level of available medical care. Accordingly, medical doctors should have the duty of recommending patients to change a hospital (i.e. when a medical doctor finds him/herself not to give appropriate medical examination and therapy, he/she shall have the duty of giving explanation to the patient and recommending that the patient should move to an appropriate medical institution). The level of available medical care should be based on publication at meetings of scientific associations or in journals, discussion, and additional studies (refer to Matsukura's report above). Precedent cases also indicated that a new therapy attains the level of available medical care only after the following process: many additional studies of the new therapy have been performed and the new therapy has been accepted by relevant scientific associations as a valid therapy; and subsequently, the new therapy has, through the use of education, been widely spread and planted its roots in clinical practice performed by specialized medical doctors (refer to the judgment made by Fukuoka High Courts on June 21, 1982).

As a specific example, the Supreme Court adjudicated on March 30, 1982 that as of the beginning of 1970, light coagulation method for the treatment of retinopathy of prematurity was at the trial stage where only researchers taking a leading part in this particular field began to perform this method on an experimental basis, and therefore, no duty of giving explanation & instructions nor duty of recommending change of hospital was recognized from the view point of the level of available medical care. The Courts judged that this therapeutic method attained the level of available medical care in 1975 when the Study Group of the Ministry of Health and Welfare published the "Study Report concerning Diagnosis and Therapeutic Standards for Retinopathy of Prematurity" (refer to the judgment made by the Fukuoka High Courts on June 21, 1982 and the judgment made by the Supreme Court on March 26, 1985). In this case also, we have to pay attention to the fact that reports presented at meetings of scientific associations or reports provided the yardstick for determining validity of medical care.

The discussion above is concerned with civil liability. Regarding criminal liability also, when determining whether or not criminal death caused by negligence in the conduct of business (under Article 211 of the Penal Code) is constituted, the level of available medical care is used as the criterion, on the basis of which is decided whether or not the medical doctor concerned has violated the duty of care that he/she should fulfill when performing the medical care act concerned (refer to "Criminal Liability for Medical Care-Related Accidents" authored by Osamu Sakuma in a book "Contemporary Medicine and Medical Affairs Law System" edited by Masayoshi Ohno). Regarding selection of operative procedures for surgical treatment, however, the fact that medical doctors are allowed to exercise their own discretion is considered as follows: since the medical doctor concerned selected the operative procedures concerned for surgical treatment on the basis of his/her own expertise and experience, his/her legal responsibility cannot be called for, and the range within which medical doctors are allowed to exercise their discretion is determined by the level of available medical care (refer to Sakuma's report above). We do not find many such cases among precedents and the majority of the precedent cases are related to rudimentary errors.


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