Section 4: Limits of Legal Regulations
4A: Restrictions on Freedom of Learning & Research
(1) Limiting studies of life sciences means limiting research activities, i.e. limiting freedom of research. Academic freedom is guaranteed in Article 23 of the Constitution of Japan. This is specifically regarded as part of mental freedom (i.e. freedom of conscience, freedom of expression, freedom of religion, etc.) and direct limitation of the freedom should require evident justification. Ultimately, total evaluation of such limitation is required, which includes evaluation of the tradeoff between public benefit obtained from such limitation and those damaged by such limitation, methods of imposing limitation, and any other relevant matters. None of the currently effective laws or regulations expressly impose restrictions on research itself and accordingly, careful and substantial examination is required. (The Nuclear Reactor Regulation Law is an example of a law that primarily controlled studies at universities and research laboratories for a while after its establishment since there existed, at the time the law was established, only a small number of practical uses of the technology that were intended to be controlled by the law. This Act is frequently referred to when discussing restrictions on research. However, as will be described later, this Act does not control research itself.)
(2) Academic freedom usually consists of (1) freedom of learning & research, (2) freedom of presenting research results, (3) freedom of teaching, and (4) autonomy of universities. Regarding the subject of these rights of freedom, as the Supreme Court in the Poporo case adjudicated that "the reasons why it is stipulated that academic freedom is guaranteed are because in part, it is intended that the freedom is guaranteed widely for all the peopleˇÄ and because in particular, it is intended that the freedom is guaranteed at universities" (Supreme Court judgment on May 22, 1963), learning & research at universities and at academic society meetings are not the only subjects of these rights of freedom. (In recent years, as described in a section entitled "Academic Freedom" in the book "Basic Law: Commentary of the Constitution" authored by Shin-ichi Takayanagi and Keigo Ohama, there is an increasingly prevailing theory which claims that academic freedom is not guaranteed as any special privilege of the faculty members of universities but this guaranteed academic freedom aims at achieving freedom from the citizen's viewpoint inside research laboratories and educational institutions.)
Regarding academic freedom, a variety of theories and case precedents were concerned with the pre-War academic control by the national government of social science and cultural sciences, and with the post-War freedom of learning and autonomy at universities. In recent years, more discussion has focused on control of freedom of learning & research in connection with advanced science and technology, e.g. control in the fields of large-scale technology such as nuclear energy, gene technology such as gene recombination, and reproductive technology such as in vitro fertilization. Among these, the issue of regulating experiments of gene recombination is a focus of active discussion as described below.
One of the relatively early reports focusing on this issue presents the following view: "we have to say that the situation in which 'research' such as experiments of gene recombination which may be a threat to human life/survival is freely performed without adequate control would be a problem. However, such conflict between academic freedom and the other value may not frequently occur when considering the nature of scholarship. Even if 'too much' academic freedom should bring about 'adverse events,' such adverse events should as a rule not be controlled by any means of power but instead be voluntarily resolved by individuals involved in academic studies. The above-described situation as examples in academics should be an issue regarding which the administrative power or the legislative power cannot intervene without reasoning, and should primarily be determined on the basis of autonomy or independent judgment of scholars and of the center of learning (i.e. universities and research laboratories). If the political power attempts to establish standardized rules through laws and regulations to control the way of learning, then advancement in academic studies and therefore general development of culture may be inhibited." (Quoted from the book entitled "Lectures on the Constitution" authored by Naoki Kobayashi.)
The background of this view is deeply rooted in the philosophy in favor of academic freedom itself, as stated below: "Academic freedom is supported by the awareness that creative freedom is essential for pursuing truth and also implies the reasonable justification that the conscience and judgment of specialists involved in research and teaching should take priority over political or administrative judgments or requirements. Accordingly, a social atmosphere which fails to respect the duties and independence of researchers based on the above-stated justification may reduce social power supporting academic freedom. What is utmost important for supporting academic freedom is respect and expectation of the general society for academic studies." (quoted from the same book as described above).
Regarding the issue of controlling studies of life sciences, however, it is increasingly necessary to evaluate this matter separately from the general principles because of the following reasons: (i) application of cloning technology (as will be described later) is associated with important problems which affect the life and death of humankind and for this reason, people do not support the idea that conclusions are drawn only on the basis of the conscience and judgment of specialists; (ii) studies of life sciences have so far been primarily performed at universities, whereas their center has been shifted to, especially at an accelerated rate in recent years, private enterprises (including medium- to small-sized companies such as venture businesses); (iii) evaluation of the trends in studies of life sciences indicate the existence of international corporate strategies, with US companies being as the center, to establish venture businesses through the utilization of state-of-the-art technology; and (iv) regarding cloning technology, UNESCO also indicates its intention to reinforce regulations (note that UNESCO submitted "Recommendation Regarding the Position of Scientific Researchers" in 1974).
(3) Many scholars of constitutional law claim that academic freedom is absolutely free as long as it involves mental activities, but academic freedom is only relatively free when it is related to selection of research methods (refer to "Academic freedom and autonomy of university" authored by Yukio Matsui, Jurisuto No. 1089) and when it involves various external activities which are visible to the outside and are necessary to conduct studies (refer to the book entitled "The Constitution" by Akira Ueda and Ichiro Asano) since in these cases, academic freedom may conflict with legally protected interests. As specific examples, experiments on living humans and violation of privacy are cited. The main theories published so far regarding limitations of academic freedom with special regards to gene recombination can be divided roughly into the following two categories.
(i) Theory of voluntary ruling
<1> Shin-ichi Takayanagi and Keikichi Ohama "Academic freedom" in the book "Basic Law Commentary of the Constitution"
<2> Masanari Sakamoto "Constitutional Theory 3"
<3> Naoki Kobayashi "Lectures on the Constitution"
<4> Takashi Narushima "Academic Freedom"
<5> Yoshiaki Yoshida "Discussion about The Constitution of Japan: new version"
<6> Tomoyoshi Morita: "The Constitution of Japan"
(ii) Theory of national regulation
<7> Koji Tonami "Constitutional problems in connection with regulation on science and technology" Jurisuto No. 1022
<8> Koji Tonami "Constitution and academic studies as well as science and technology"; Yoichiro Higuchi "Lecture on Constitutional Study No. 4: Guaranteeing Rights No. 2"
<9> Nobuyoshi Ashibe "Academic freedom No. 1" Hogaku-Kyoshitsu No. 157
<10> Takeshi Kobayashi and Toshikatsu Minami, editors "Current Status of the Constitution of Japan"
The above-listed reports and books discuss the issue of regulating academic freedom from various viewpoints and stress the points that will be discussed later in this POLICY STUDY. Here, the authors would like to introduce several points which also involve our investigation in this Report.
The report authored by Tonami <7> refers to the fundamental law in Germany and justifies regulating life sciences-related technology in particular because of "human dignity" (and therefore concludes that manipulation of fertilized eggs or human genes is unethical). Report <8> argues that regulations of life sciences-related technology are based on the prescribed provisions to protect rights (e.g. the right of life, protection of family and the right of personality) in the Constitution and that behind these provisions, the principle of respect for human dignity exists (and therefore concludes that limits of life sciences-related technology must be defined by laws). Regarding this point, the authors consider it difficult to regard human dignity as a direct reason for regulation, since human dignity itself is abstract and as will be described later, it is recognized that many life sciences-related technologies, e.g. in vitro fertilization, cloning technology, and analysis of human genomes involve human dignity (note that this matter will be discussed in detail in Section 6.3).
Assuming that effects of science and technology cannot be fully foreseeable in advance, Tonami's report <7> claims that range and extent of damage can be great and serious, which requires regulations by the nation. On the contrary, Sakamoto claims in <2> that because such effects cannot be foreseeable, there is no reason for the nation to impose regulations on science and technology. Since effects of advanced science and technology cannot be fully foreseeable and in addition, the currently accepted common view (i.e. the idea of research) is always open to criticism, it is expected as a matter of course that ultimately, the nation may need to take all responsibilities for working out solutions.
Tonami's report <7> lists the following reasons why regulations should be imposed by laws: (a) for the purpose of defining limits of science and technology; (b) for the purpose of restricting the freedom of research, a human right; (c) because it is difficult to determine limits of regulations; (d) because public opinion must agree with the control of science and technology and in this respect, establishment of a law is the most appropriate; and (e) because respecting voluntary judgments of researchers may discourage them from being active toward research. On the other hand, another report by Tonami <8> claims that it is inadequate to work out comprehensive resolutions for science and technology as a whole and accordingly, regulations need to be reexamined on the basis of a variety of actual experiences. A choice between two positions, either regulations by law or voluntary ruling, may encounter many difficulties.
(4) In light of the above-described views, the authors would like to fully examine the following 3 points that should be taken into account when investigating regulations on the freedom of research.
(i) What danger and harm would occur if research (or technology) is left to stand (i.e. is not regulated), and which benefits would be lost if such regulations are imposed?
(ii) In cases where regulations are required, which types of regulations would minimize burdens given to the individuals to be regulated and still be effective?
(iii) Is research only regulated or is research by researchers simultaneously regulated as part of the framework of regulating the general public?
Regarding (i) and (ii), since substantial differences are noted among individual science and technology fields, for which the necessity of regulation is now under discussion, we need to investigate them individually and specifically. The authors consider it difficult to have comprehensive discussions about life sciences induced risks and confusion in the social order since experiments of gene recombination, reproductive medical technology such as in vitro fertilization and surrogacy, and cloning technology would violate substantially different legal and social benefits. The authors will discuss these issues while showing specific examples: (i) will be discussed in Section 6 and (ii), in Section 5. The authors will discuss (iii) in Section 4B.
The basic position of this POLICY STUDY Report is that generally, even "the freedom of learning & research" may be regulated for the sake of public welfare, provided that the contents of technology in question are analyzed in detail and advantages resulting from such regulation as well as how such regulation is imposed are identified.