Part 2: Guidelines Established by Countries and Academic Associations
(Authored by Minoru Kuniya and Mami Oyama)
1. Guidelines Regarding Life Sciences
(1) The authors have so far discussed regulation of life sciences, assuming that such regulation would be based on legislation. Some claim, however, that voluntary regulation by researchers is more appropriate since it is highly likely that this type of regulation may be imposed on research itself in reality. Voluntary regulation by researchers may comprise voluntary standards or guides for restriction issued by scientific associations or any other relevant bodies.
Regarding voluntary regulation by researchers, various guidelines have already been set out in a diverse range of research fields by scientific associations, etc. It is pointed out that these guidelines are not sufficient to cope with the issue of regulating cloning technology since these guidelines are basically effective only among those who participate in scientific associations and even if some researchers violate the guidelines, they are only expelled from the relevant association and no additional punishment is available.
Regarding guidelines for reproductive medical technology, the Japanese Association of Gynecology and Obstetrics announced the "Opinion about in vitro fertilization and embryo transplantation" (as an association's announcement in 1983), followed by the 11 association's announcements listed below. The members of the Association are all aware of these opinions.
<1> "Opinion about in vitro fertilization and embryo transplantation" (1983)
<2> "Opinion about studies handling human sperm, ova, and fertilized eggs" (1985)
<3> "On a system of registering and reporting clinical implementation of in vitro fertilization and embryo transplantation" (1986)
<4> "Opinion about whether or not organs, etc. from dead fetuses or newborns are used in research and about the range of permissibility" (1987)
<5> "Opinion about fetal diagnosis for any malformation, with special regard to chorionic villi sampling (CVS) during early period of pregnancy" (1988)
<6> "Opinion about freezing/storing and transplanting human embryos and ova" (1988)
<7> "Opinion about clinical implementation of microscopic fertilization method" (1992)
<8> "Opinion about safety of use of Percoll method in choosing a sperm having X-chromosome or one having Y-chromosome" (1994)
<9> "Opinion about multiple pregnancy" (1996)
<10> "Opinion about artificial insemination between non-spouses and sperm donation" (1997)
<11> "Opinion about the range of clinical application of in vitro fertilization and embryo transplantation in humans" (1998)
<12> "Opinion about pre-implantation diagnosis" (1998)
(2) On the other hand, the Ministry of Health and Welfare and the Ministry of Education have issued guidelines for life sciences. These guidelines function as standards at national universities, medical institutions under the jurisdiction of relevant authorities, and institutions supervised by the administrative office according to laws within the jurisdiction of relevant authorities. Unlike the guidelines issued by scientific associations, some of them are legally valid as an order of the administrative authority.
<1> Announcement by the Ministry of Education "Guidelines for Recombinant DNA Experiments at Universities, etc." (March 31, 1979)
<2> Announcement by the Ministry of Health and Welfare "Guidelines for Clinical Studies of Gene Therapy" (February 8, 1994)
<3> Announcement by the Ministry of Education "Guidelines for Clinical Studies of Gene Therapy at Universities, etc." (June 9, 1994)
Regarding regulation of studies of cloned humans which is currently the topical issue, the Bioscience Group, the Subcommittee for Promotion of Research in Specific Fields, Science Council issued a report entitled "Research on Cloning at Universities, etc." on July 3, 1998. In this report, "drafted guidelines for regulation to be imposed on research of creation of cloned human individuals at universities, etc." were shown and the following idea was stated: considering the point that regulation should be the same to all researchers at universities, it was considered appropriate that guidelines on research of cloning at universities, etc. be formulated by the Ministry of Education and be put to practical use according to professional investigation and examination by Science Council. On the basis of this view, the Ministry of Education announced the "Guidelines for Research of Creation of Cloned Human Individuals at Universities, etc." in August 1998.
(3) Regarding gene recombination, the Prime Minister decided the "Guidelines for Gene Recombination Experiments" on August 27 1979, in response to Advisory Opinion No. 8 of the Council for Science and Technology, an advisory commission of the Prime Minister, "On the Basis of Promoting Policies for Gene Recombination Studies." The authors will describe the details later again.
2. Effects of Guidelines
(1) It is acknowledged that the history of voluntary standards for life sciences (including medical practices and experiments) traces back to ancient Greek times and began with the "Hippocratic Oath." An epoch-making movement occurred after World War II, which was triggered by repentance following the experiments on humans conducted in Nazi Germany. The "Nürnberg Code" formulated through the progress of the Nürnberg War Tribunal had a great influence on subsequent moves. Along with subsequent events including the "Declaration of Helsinki" issued by the World Medical Association, the world's first successful heart transplantation in South Africa in 1967, and the discovery of the Tuskegee case in the US, various standards were born in countries over the world. In the "Encyclopedia of Bioethics" (published by the Kennedy Institute of Ethics, Georgetown University), the initial standards pertaining to medical practices are listed as described below (refer to the translation by the Planning Bureau, the Science and Technology Agency).
{General codes involving medical practices}
{Directives involving experiments on human bodies}
An event requiring particular attention is the establishment of the National Research Act in the US in 1974 which is intended to protect human subjects in scientific research. On the basis of this Act, the "Ethical Principles and Guidelines for Protection of Humans in Clinical Studies" was formulated, which is applied to research involving human subjects subsidized by the Department of Health & Human Services. The Ethical Principles and Guidelines prescribe that a researcher who intends to perform a clinical study shall obtain approval from an institutional review board (IRB), the establishment of which shall be the duty of each relevant medical institution, prior to submitting an application for subsidies to the Department of Health & Human Services. Immediately following this, the Declaration of Helsinki was revised at the Tokyo Conference of the World Medical Association and the revision contains additional points, among others, as follows: a scientific experiment involving human subjects shall be discussed, reviewed and directed by an independent committee; and publication of reports which do not comply with the principles of the Declaration shall be refused. In Japan also, an institutional review board was first organized at the Medical Research Laboratory, Tokyo University in 1981.
In recent years, informed consent has been given particular importance in the field of medical practices. This is also the product of standardization in science & technology related areas such as experimental medical practices and clinical development of new drugs. The US President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research issued a report outlining informed consent in 1982. This report expands use of informed consent to therapies and made a proposal that the theory of informed consent is based on laws but has ethical characters and therefore, informed consent should be treated as an ethical issue.
In the field of gene technology research, Watson and Crick discovered the double-chained structure of genes as early as 1953. In the US, Cohen and Boyer first succeeded in gene recombination in 1973. According to a proposal made by the National Academy of Science (NAS), the Ashiroma Conference was held in the State of California in 1975. In light of the Conference results, the NIH prepared guidelines for gene recombination in 1976. The Guidelines formed the basis of subsequent guidelines for gene recombination experiments in Japan and other countries.
The various guidelines thus formulated function as standards in life sciences and medical practices, although many of them are not legislative but treated as autonomic ethics. Guidelines in Japan also follow this principle.
(2) Regarding guidelines for gene recombination, the Recommendation in response to Advisory Opinion No. 8 of the Council for Science and Technology was published, i.e. "On the Basis of Promoting Policies for Gene Recombination Studies." This Recommendation stated that potential risk which was predicted at the beginning of discussion remains still now within the range of hypothesis and accordingly, regulating gene recombination studies by laws may not be appropriate but instead voluntary observance of the guidelines by researchers is desirable. The report issued by the Life Sciences Committee of the Council for Science and Technology, which had been published prior to the Recommendation above, stated that regulations to be imposed on gene recombination experiments should follow the methodology accepted in foreign countries, reflect considerations given so as to agree with guidelines issued by the Ministry of Education, be reviewed as appropriate according to availability of new scientific knowledge and information, and be based on internal demands within life sciences related fields so that it is desirable to position research on the basis of proper understanding of the society. It seems to us that the report gave considerations to a possibility that these conditions may be damaged if guidelines are ruled by law.
The authors need to undertake further discussion to determine if the present guidelines have a legal effect or not, however. We would like to introduce the most recent two cases pertaining to the guidelines for gene recombination.
(i) Firstly, there were two law suits involving the guidelines for gene recombination experiments: in one case, an injunction was claimed against use of Experimental Room P4 at the Life Sciences Tsukuba Research Center of RIKEN (the Physical & Chemical Research Laboratories); in the other, a motion was filed that gene recombination research performed at the NIH (the National Institutes of Health) should be banned. In the former case, the motion was ruled out by the Court (the Tsuchiura Branch of the Mito District Court) on June 15, 1993. This judgment stated as follows: the Japanese guidelines for experiments are not special at all but it is understood that they are used since they are generally appropriate; on the other hand, the contents of the Japanese guidelines are more stringent as compared to guidelines or any other relevant rules in the US and accordingly, the safety is secured. Usually, in civil cases involving a motion of injunction or a claim for damages, the following principles are employed: <1> the plaintiff has the burden of proving that the act causing damage is illegal; and <2> the Court examines the case, on the basis of evidence, and establishes the facts by itself and makes its own judgment. However, prior to the case described above, the Supreme Court had adjudicated in the case of Ikata Nuclear Power Plant law suit that <1> when the Court examines the case and makes judgment, such examination and judgment should be made from the viewpoint of whether there exists any unreasonable points in the judgment made by the administrative office on the basis of professional and technological investigation, examination and judgment, e.g. those made by the Atomic Energy Commission and that <2> although the plaintiff as a rule should have the burden of proof, the defendant administrative office is required to prove on the basis of reasonable evidence and information that their judgment contains no unreasonable points, considering the fact that the relevant information is all retained by the defendant administrative office. This Supreme Court judgment indicates transfer of the burden of proof from the plaintiff to the defendant and movement from the judgment based on the Court's independent fact finding to the judgment based on results of examination for unreasonable points in the administrative office's judgment. In the above-described case involving gene recombination, the judgment stated that "irrespective of form of documented judgment, the true intention of examination and judgment agrees with the contents indicated by the Supreme Court's judgment made in the Ikata Nuclear Power Plant case as mentioned above" (Hanrei Jiho No. 1467). It is therefore considered that the national guidelines stating that voluntary observance of the guidelines by researchers is desirable, have similar effectiveness to that achieved by the standards based on the Nuclear Reactor Regulation Law (although there is a difference from "presumption of lawfulness" which "official power" has, we can see that in the guidelines also, some presumption is performed since the Court does not examine nor judge the contents of standards from the scientific viewpoint).
This of course follows the logic that what complies with guidelines (standards) does not need to be banned since its safety has been confirmed. This does not directly lead to a judgment that what does not comply with standards, which is the issue, can be banned since its safety has not been confirmed (injunction is applicable to the private person; in the case of administrative office, non-licensing is applicable). Nevertheless, the above introduced cases may worth referring to.
(ii) Secondly, for gene recombination guidelines, the municipal government of Suita City, Osaka Prefecture established the "Bylaw to Secure Environmental Safety in Facilities Involving Gene Recombination in Suita City" in October 1994. In Suita City, there exist 13 business units in 7 locations where gene recombination is performed. The Bylaw is intended to take all possible measures to prevent hazards caused by unforeseeable and unknown dangers, and prescribes the following as mandatory: submitting various notifications, consultation, making agreements, retaining records, reporting, and acceptance of on-the-spot inspection. Regarding safety, the Bylaw stipulates that "the person conducting business shall observe the guidelines for recombination experiments and the other guidelines prescribed by regulations and rules," according to which the Bylaw requires observance of the national guidelines in terms of safety (note that the expression "the other guidelines prescribed by regulations and rules" include the Announcements by the Ministry of Education described above). Regarding the necessity of establishing this type of by-law, some views claim that no additional regulations are necessary if they are substantially the same as existing ones. The other support the Suita City's action by arguing that we cannot deny the fact that the Bylaw gives legal binding power to the standards prescribed by the national guidelines, which enables us to make a legal judgment indicating opposition against some researchers who are not mindful of the national guidelines, ignore them, and make their own way in research (refer to "Legal issues in connection with the Suita City's Bylaw regulating gene recombination facilities" authored by Kaoru Inoue, Jurisuto No. 1064). Apart from whether or not the existence of these double-binding standards is a desirable situation for the people or not, we can consider that if there exist norms which should function as safety standards when they are incorporated into a bylaw, such norms, together with the above described precedent cases, are not legally meaningless but may have certain legal effects.
From now on, the authors will make further investigation on this matter.
{Note} Our discussion in next sections onwards will be primarily based on national guidelines. Before moving forward, we would like to discuss effects of guidelines issued by scientific associations, i.e. {legal effects of voluntary standards}.
Like a person who performs an act which is not contrary to ethics, business entities and individuals engaged in business set self-regulating standards (voluntary standards) as a code of practice when performing their business. These voluntary standards exist in various fields including, among others, production, business transaction, maintenance of environment, education, medical care, settlement of disputes. An extremely small number of reports have discussed legal effects of voluntary standards, however. Here, we will discuss this matter by referring to a report "Voluntary Standards and Laws" authored by Jisuke Nagao. Nagao's report focuses on acts involved in business transaction and his scope of discussion is not as wide as that in this Report. However, his report is primarily based on analysis of precedent cases and contains views which are applicable to general issues. The authors therefore would like to introduce his report.
Voluntary standards are prepared by an industry association, members of which are companies to the same industry, and are expected to be observed by those member companies. Voluntary standards therefore prescribe criteria for directing and handling the members and thus function as providing models in certain cases. The authors will not touch on this function here, though. Nagao's report pointed out that voluntary standards have the following four functions which are legally significant: (a) a function to contribute to clarification of legal concept contained in articles of laws (for which he referred to the judgment made by the Tokyo High Courts on July 18, 1980 that the State should, when making a judicial judgment, give importance to the examination criteria for obscenity issued by the Film Ethics Regulatory Committee as a piece of information which helps the State estimate the popular view on obscenity in the society); (b) a function to define the meaning of acts performed by the individuals involved in a dispute; (c) in the case in which the domestic written rules and regulations grant legal effects to voluntary standards formulated by industry associations, a function to constitute specific details of such laws of voluntary standard; and (d) a function to identify legal elements. In connection with the function to identify legal elements in particular, he examined unlawfulness and the duty of care.
When looking for precedent cases at lower levels of courts, he found out the view indicating that voluntary standards constitute the ground of judgment of unlawfulness or as the ground of violation of the duty of care. The judgment of unlawfulness can be divided into the following three categories: <1> unlawfulness is judged because the rules of faith are violated; <2> unlawfulness is judged and therefore, liability for damages on the basis of non-fulfillment of obligations or torts is accepted; and <3> unlawfulness is judged because the act concerned is contrary to public policy or good morals. In law suits, voluntary standards are treated as at least an important factor when unlawfulness is judged in <1> and <2> (refer to the judgment made by the Osaka High Courts on September 24, 1991 and one made by the Kyoto District Court on November 26, 1968; and also the judgment made by Yokohama District Court on December 18, 1987 in which voluntary standards were accepted as an element). On the other hand, when a contract is judged to be invalid because of the ground stated in <3>, it is understood that voluntary standards do not function as a sole factor leading to a judicial judgment that the act concerned is contrary to public policy or good morals (refer to the judgment made by the Osaka High Courts on September 24, 1991).
Regarding judgment of negligence, considering the feature that voluntary standards express what corporate activities should be in order to meet the demands of the society, when a violation occurs in relation to an item subject to regulation of voluntary standards and a person who suffers from damage caused by such violation makes a claim for compensation for the damage, voluntary standards have the significance that they provide a yardstick for evaluation of the duty of care. In specific cases, however, it is unavoidable to set limits to a scope in which this significance functions (refer to the judgment made by the Yokohama District Court on December 18, 1987 and one by the Tokyo District Court on December 25, 1989).
The precedent cases introduced above are related to commodity exchange and not a small portion of the voluntary standards discussed above are incorporated into the framework of administrative regulations and rules pertaining to the commodity exchange industry. Nagao's report pointed out that these voluntary standards do not always provide the immediate significance of the order between the parties concerned. In the judgments introduced above, unlawfulness was not only based on voluntary standards but also on the relevant laws. In addition, there was a judgment which is evidently contrary to the true aim of Nagao's report (i.e. the judgment made by the Hakodate District Court on October 24, 1975 that for an act which violates model-regulations and laws, we cannot say that this act constitutes a tort because of the violation; note that some scholars criticize this judgment). Accordingly, it may be dangerous to draw any universal conclusion on the basis of these limited judgments. Nevertheless, the above described points and cases may indicate that it may be inappropriate to consider that voluntary standards have no evident legal effects in all cases.
Considering the fact that the entity establishing standards under discussion of this Report is not industry associations which consist of companies doing business for the purpose of profit-making but scientific associations, the authors consider that there exist great differences between voluntary standards of the two types in terms of effects.