4B: Regulation of Technology at the Stages of Research and Practical Use
(1) When investigating regulation of research activities, it is considered useful to divide the process of science and technology into two categories, i.e. research, and application of technology (in order to utilize the results of research), according to which views should be placed separately. Regarding life sciences, there exist many difficulties in dividing them into these two categories. On the other hand, it is not unnatural for general science and technology to be divided into the two.
Specifically, it is appropriate to divide application of advanced technology into two stages, i.e. one at which researchers apply the technology concerned in order to increase scientific knowledge and findings and the other at which not only researchers but also various types of people (including engineers) apply the technology concerned by incorporating it in specific processes such as production. Technology at each of the stages would have the following impacts on the society.
(i) Technology at the stage of research
Individuals who apply the technology at this stage primarily comprise researchers at universities. The size of laboratory, financing, and manpower is small. Should an accident occur, the extent of damage is expected to be minimal.
(ii) Technology at the stage of practical use
Individuals who apply the technology at this stage primarily comprise engineers working at private enterprises. The size of plant, financing, and manpower is considerably large. Should an accident occur, there exists the possibility that such an accident may bring about severe damage.
For example, animal experiments of cloning technology has made progress with an aim of improving reproductive technology for animals, which has resulted in discussion about creation of a cloned human baby. At present, there have been reports concerning production of cloned animals such as cattle and sheep, and of differentiation of human embryos up to specific stages of development. Creation of a cloned human baby has not been undertaken. Although this example may be conceptual, it suffices to demonstrate that it is not adequate to discuss regulation of research activities under circumstances where, as in this example, there exist confusion between the stage of research (i.e. fundamental research) and the stage of applying such technology to practical use in the society.
(2) The relation between research and application of a new technology which is the product of such research has been discussed and explained in a relatively simplified manner. Various research activities have been appreciated since they put useful ideas, which society has long looked for, such as provision of consumer goods, transportation and telecommunication, to practical use in an effective and efficient manner, or they increase options of measures to facilitate such realization. When looking at individual types of research, whether a particular technology is to be applied or not has been decided on the basis of results obtained from (a) research to bring about the creation of the technology that is expected to be applied to society or (b) research from the viewpoint of examining that technology. In addition, it has been accepted that there is another type of research (c) which has a role of providing an alternative technology or a supplementary technology when a problem occurs or may occur at the time of application of the original technology.
When taking nuclear energy development as an example, we can say that there existed reactor engineering research and other relevant research which forms the base of nuclear energy development (a), and that along with this engineering and environmental safety research was undertaken (b). In surrounding areas, material research, monitoring research and research of instrumentation control technology was performed (c). Accordingly, in order for a particular technology to be applied in society, a variety of well-established fields related to the technology have to be fully studied, as shown in the above-described example, and it must also be considered to be in the interest of the entire society.
On the other hand, research activities have been highly evaluated even if they do not directly give rise to any specific social utility such as production, since they promote the wisdom of humankind and thereby have further extensive impact on society. As a matter of course, many of the results of research in this category brought about inventions which could drastically change the root of human society because of unintended use of these results. In recent years, national governments of several countries have strategically focused on promotion of research which is expected to have an extensive impact rather than research which is undertaken from the beginning to achieve a specific objective.
(3) Regarding regulation of research related to a new technology and of application of the technology, there are specific cases in which the above-described circumstances are taken into account: application of technology at the stage of research is intentionally, i.e. as a matter of policy, separated from application of technology at the stage of practical use, and then, the latter is as a rule made the subject of regulation while on the former, restrictions are relaxed when special conditions are met.
(i) Nuclear energy development: An example of the old "Nuclear Reactor Regulation Law"
The old "Law Concerning Regulation of Nuclear Source Material, Nuclear Fuel Material and Reactors (Nuclear Reactor Regulation Law)" (established in 1957) prescribed that a person who intends to install a reactor shall obtain permission for such installation from the Prime Minister or any other relevant individual (in Article 23), shall obtain license regarding the design and construction methods (in Article 27), and shall be subject to pre-operation inspection and regular inspection (in Articles 28 and 29). The Japan Atomic Energy Research Institute, however, was allowed to install a reactor without obtaining permission for the installation (note that the Institute had to obtain a license regarding the design and construction methods and had to follow other relevant requirements). This was because the Japan Atomic Energy Research Institute was established under a special law, and was intended to perform research and other relevant activities related to nuclear energy development in a comprehensive manner. The Institute had already been organized as a foundation in 1955 before the establishment of the Law, and had accumulated substantial achievements in nuclear energy related research, which was extremely limited in Japan at the time. It was therefore prescribed by the Law that this Institute did not need to obtain permission for installation of a reactor. Subsequent amendments, however, require the Institute to obtain permission for reactor installation, as does anyone else who intends to install a reactor.
<Note> The Nuclear Reactor Regulation Law strictly limits exposure of radiation to the human body in order to prevent radiation hazards under the regulatory system by this Law: installation of a facility that produces exposure levels beyond the prescribed permissible level is prohibited; and activities which cause exposure of the operators concerned to levels beyond that prescribed are restricted. Regarding nuclear reactors for which utilization for medical research is licensed by the regulatory authorities, however, it is authorized that large quantities (which exceed the permissible exposure dose) of neutrons and any other relevant substances taken out from the reactor may be used in irradiation treatment of patients with brain tumor or any other relevant disease (note that currently, some research reactors including JR4 of the Japan Atomic Energy Research Institute have obtained this license).
(ii) Research of poisonous substances: The Poisonous and Deleterious Substances Control Law
The Poisonous and Deleterious Substances Control Law stipulates that only those manufacturers that have been officially registered as manufacturers of poisonous or deleterious substances shall be allowed to manufacture specified poisonous substances (in Section 1 of Article 3-2) and that only those importers that have been officially registered as importers of poisonous or deleterious substances shall be allowed to import specified poisonous substances (in Section 2 of Article 3-2). On the other hand, individuals who receive licenses from the prefectural governor as being entitled to manufacture or use specified poisonous substances for scientific research (i.e. the researchers of specified poisonous substances) are allowed to manufacture or import such poisonous substances.
(4) Of course, it is a matter of policy to differentiate, in terms of regulation, technology at the stage of research from technology at the stage of application for practical use, and such differentiation is not a legally essential condition. Generally, regulations on research are frequently relaxed in the following situations: <1> when application of a new technology provides extremely great utility for society; <2> when there is strong social demand for promotion of research with an aim at obtaining knowledge about effects of a particular technology prior to its application; <3> when it is considered that comprehensive regulation for the sake of practical use may cause great hindrances to research; <4> when it is acknowledged that generally, research constitutes small-scale experiments performed within a laboratory room and also is greatly diversified, the safety of which can be secured when research is performed under the supervision by specialists having sufficient and extensive knowledge such as researchers and also under regulatory conditions; and <5> when it is considered feasible that a system sponsored by the nation or an institution equivalent in authority to the nation may work as appropriate.
Usually, (fundamental) research differs from application of technology at the stage of practical use because all processes of the technology concerned at the stage of research are not applied all together at the same time. In the case of life sciences, for example, experiments or studies are frequently performed for individual detailed processes such as development and differentiation. If research of each process in detailed steps can be performed even if the entire process concerned is regulated, then such research can in many cases be useful.
Under these assumptions, the authors would like to address the following issue from the general viewpoint: For which types of research are measures to relax regulations required when regulating advanced technology? Of course, this investigation should be made for individual technologies according to their individual characters.
The first character of a technology is that which is highly likely to be applied in society in the future, although confirmation of safety of the technology is required. An example of this is manufacture of new drugs or foods through the use of gene recombination. In this case, application of new technology requires development of safe organisms and methods which are more appropriate to achieve the set objectives and the gathering of relevant information. Accordingly, it is not unfair to consider measures to relax regulations for the purpose of promoting research required for the development and the information gathering, which differs from regulations to be imposed on technology at the stage of practical use.
The other character of a technology is that in which results caused by application of the technology will not be accepted by society for the time being whatever the underlying reasons behind the research. An example of this nature can be technology which is only intended to harm or kill humans. In this case, the reasoning is that if it is decided not to apply the technology concerned to practical use, then it is not necessary to promote research related to that technology. There is little necessity to relax regulations at the stage of research since restrictions are to be imposed at the stage of practical stage.
(5) On the basis of the above-described view, the authors would like to investigate cloning technology. Usually, there rarely exist a combination of a single objective with a single method to achieve that objective of research. Various methods are used to achieve an objective and the same method can be used in several studies having different objectives. Regarding cloning technology, therefore, there can be studies which use cloning technology not for the purpose of creating a cloned human baby but for other purposes. Whether such studies are specific, since they identify the different objectives to that they aim to meet, or general since they intend to look into the truth, their promotion is as important as promotion of fundamental research of the other life sciences as long as results of such studies may elucidate mechanisms involved in, for example, human development or differentiation of cancer cells.
At the same time, we have to pay special attention to the recent change in quality of science and technology. The traditional types of science and technology indicate clear differences between the stage of fundamental research performed at university laboratories and the stage of technology development for application to practical use in terms of financing, human resources, and facilities, all of which have to be upgraded when transferring from the research stage to the practical stage. In addition, decision making and responsibilities are clearly different between the two stages (e.g. nuclear energy-related research, space-related research). In recent fields of science and technology, the borderline between research and practical use are not well-defined, which brings about a gradually increasing number of cases in which research results can be directly applied to society (e.g. life sciences, information technology). With special regard to life sciences, the possibility of producing an immediate effect on humankind cannot be ruled out. In cloning technology, for example, the cloned sheep was produced when the research concerned was completed.
Considering these facts, the authors' basic view is, as described above, that since there exist regulations imposed on ordinary citizens, it is unavoidable that researchers are also regulated within the range of these regulations, in accordance with the potential danger caused by application of cloning technology.
(6) There are several laws and regulations which limit research activities by researchers as part of the framework of regulating the ordinary citizen. For example, legal controls of specific substances limit the use of those substances (e.g. the Law of Prevention of Radiation Hazards regulates the use of isotopes for research purposes), and thus limits certain experiments (e.g. tracer experiments). It is not unreasonable either that regulatory control of those consequences generated by the use of a specific material (e.g. the Radio Law regulates generation of radio waves) limits studies using such materials (e.g. study of radio waves). It is therefore not correct to consider that these regulations damage academic freedom.
On the other hand, we consider it difficult to impose restrictions only on the side of research in a certain area in which practice is generally permitted. We cannot imagine any circumstances under which practical application of a certain technology in a specific field is allowed but into which research of such technology is not permitted. We do not believe that the Constitution of Japan, which is currently in effect, will accept such circumstances.
For example, if frozen storage of sperm or ova, assistance in donating sperm or ova, artificial insemination, pre-birth examination, and elimination of a fertilized egg are widely permitted generally and legally (note that actually in Japan, artificial insemination and in vitro fertilization are performed under certain limitations) on the assumption that each individual has the right to control his sperm or her ova, it may be difficult to regulate only those studies in which sperm or ova are handled (and those of applying cloning technology in particular).
Of course, it is possible, because of the reasons stated in the previous sections (1) through (5), to utilize a law which generally prohibits any measures leading to creation of a cloned baby in order to regulate not only the creation of such a cloned embryo but also any series of relevant studies. Such regulation will require, needless to say, identification of the two aspects, i.e. social benefits and violation of the legally protected benefits which are attributable to reproduction-related medical care technology, such as artificial insemination and in vitro fertilization, and cloning technology: comparison of these two aspects is mandatory for creating reasonable regulation. (Journalism frequently uses the expression "regulation of cloning studies" when they discuss regulations on cloning. We think it necessary to clarify whether this purely means "studies of cloning only" or refers to "application of cloning technology which includes cloning studies," in order to avoid any unnecessary confusion when evaluating regulations.)
(7) Finally, the authors would like to discuss problems associated with restrictions on the freedom of learning & research. Comparison of regulations on research with those on application of technology (including research) reveals that in the former, researchers are the subject of regulation. In the latter, however, only ordinary citizens are the subject of regulation, in which there exists the advantage from the viewpoint of legal technology that immediate considerations need not be given to the attributes of the researcher. In the case where researchers are considered to be the potential subject of regulation, careful investigation of research activities is required, as indicated by the fact that there have been no regulation acts purely intended to control research. From the viewpoint of regulation in particular, it is highly likely that "legal responsibilities of researchers" may be identified, which may create various issues to be addressed. This point will be discussed in detail later in Section 7 as supplementary discussion.
Regarding the position and responsibilities of researchers, as indicated by the recommendations issued by UNESCO and other relevant statements, it has been considered that they occupy a privileged position and assume more ethical responsibilities than ordinary citizens. Along with the debut of life sciences-related problems, it becomes necessary to discuss legal responsibilities, in addition to this privileged position and the highly ethical responsibilities, of researches as in medical doctors, lawyers and other relevant professions. This is a new issue which we will have to face in the future and figure out resolutions. However, it may require a substantially long time for the individuals involved to reach a consensus regarding this new issue.