Ito Kosuke

Kiba Takao

Kuniya Minoru

Oyama Mami

第2調査研究グループ

Kuniya, Minoru

6595

Oyama, Mami

6596

Ito, Kosuke

6597

Kiba, Takao

6598

National Institute of Science and Technology Policy Library (NISTEP) / 科学技術・学術政策研究所 ライブラリ

Legal Regulations on the Advanced Science andTechnology- Regulations on Life Science -SummaryOur report centered on legal restrictions on advanced science and technology, especially lifescience and technology. The discussion covered several problems that require legalconsiderations. The two main themes were the types of possible restrictions and the way tojustify such restrictions. Our discussion can be summarized as follows:<1> Current status of life sciences and strategyLife science and technology have been a strategic field of study in many countries andconsidered, in particular, as a major source for industrial competitiveness. Perspectives andpolicies on reproductive medical technology have been quite different from those on lifescience and technology as a whole. While stringent restrictions have been imposed in Europeancountries, consensus development has been extremely difficult in the U.S., instead leading tomovements toward the promotion, commercialization and further development overseas ofadvanced reproductive technology in the private sector. At the same time, in light of growingefforts for unified regulations in Europe, it is likely that a standard will be formed for lifescience and technology used to shed light on reproductive medicine.<2> Details and History of Regulations in Several CountriesRegulatory laws have been established on reproductive technology in Britain, France andGermany. Nonetheless, the scope of such regulations varies, although slightly, from country tocountry. They differ in such details as the object of restriction. It is thought, however, that thecurrent regulations are competent enough to handle cloning technology.<3> Legal views in JapanThe Constitution, civil code, criminal code and medical laws were discussed in connection withsuch regulations in Japan.<4> Limitation on legal restrictionCloning technology was discussed in relation to academic freedom and other rights. It isconsidered that even academic freedom should be subject to a certain degree of restriction andthat, in social application of cloning technology, not only application but also research shouldbe covered by regulations without exception.<5> Objects of restrictionWhen considering regulation of cloning technology, we reviewed every possible aspect ofreproductive technology as a whole, including related technologies that would requireregulation, instead of focusing on cloning technology alone.<6> Grounds for regulation[Safety]1Safety related to cloning technology involves concerns about genetic influences on children andlater generations. Somatic nuclei, in particular, are extremely susceptible to genetic defects andhighly likely to suffer damage during the course of daily life. Humans developed from agenetically disturbed body nucleus face the possibility of succumbing to adverse effects all overthe body. We have examined several examples of regulations implemented to focus on suchgenetic effects (on statistical grounds).[Social order]In contrast to conventional reproductive technologies, which had maintained the familystructure from the past, the new cloning technology makes the relationship between the donorof a body nucleus and the cloned baby highly similar to that between monozygotic twins. It isthe first attempt in history to genetically invent such relationships, which would essentiallydisturb social order.[Conclusions on justifications for regulation]For the above two reasons, it is acceptable to regulate cloning. In asserting regulation, "humandignity" as a justification should be paraphrased in more practical terms (e.g., abuse of humanembryo and indivisibility of the human body).<7> Supplement: Legal responsibilities of researchersLittle discussion has been made in Japan on the responsibilities of researchers in advancedscience and technology. For the application of regulations on advanced technology, we need toreview our problems in a new perspective.[Weighted liability arising from negligence]The legal liability of researchers should be examined separately from that of the 'professionalliability' of experts such as physicians and lawyers, because they are quite different in nature.[General liability arising from negligence]In general criminal and civil cases, a common interpretation is established concerningforeseeability and duty to avoid risk. For the introduction of regulations on researchers, it isessential to form a new standard.<8> Guidelines by the government and academic societiesAs part of regulatory methods, guidelines are considered to have no legal effects. In ourdiscussion, we have reviewed guidelines on science and technology, especially the ways inwhich guidelines should be implemented in an effective manner. Lastly, we examinedtechnical standards in connection with the scope of judicial review on administrative discretion.<9> Consensus development effort for regulationWe discussed efforts required to reach a consensus in the public whether regulations shouldtake the form of laws or guidelines.[Interested parties required for consensus development]Interested parties to take the initiative in consensus development effort were categorized intothree groups: (1) directly interested parties, (2) other interested parties and (3) non-interestedprofessionals. We pointed out the importance of clarifying claims from these parties.2[Consensus development methodology]Conventional and new consensus development methods were introduced, including technologyassessment and consensus conferences.While we were in the process of reviewing our discussion, many new topics have attractedpublic attention, including unconfirmed news; the Ishikawa Prefectural Animal ScienceInstitute and Kinki University jointly succeeded in cloning a cow using body cells (July 5,1998); an international group composed of scientists from Japan, the U.S., Italy and Britaincloned at least 50 female mice (July 23); a U.S. scientist declared at a scientific conference thathe would clone himself (September 6, Nikkei); scientists at Tokyo University and the JapanScience Foundation succeeded in producing organs such as kidneys from an undividedembryonic cell in a frog and confirming their growth after transplanting them to another frog(September 13); Wisconsin University successfully isolated ES cells from a human embryo,and cultured and grew them (November 6); a U.S. investment company and U.S. researchersannounced that they would set up a cloning technology center in Hokkaido (December 1);HFEA of the British government submitted a report recommending permission to producehuman tissues using cloning technology (December 18); a Korean university transplantednuclei from female body cells and eggs and observed division until the egg cells were dividedinto quarters (December 15); Wisconsin university at Madison transplanted body cell nucleifrom four different mammals into bovine eggs, divided them and successfully developed theminto embryos (December 28); a private enterprise cloned a cow using a body-cell nucleus(January 8, 1999); researchers at Tottori university have grown a human spermatogonium in amouse (February 2); Italian physicians produced five humans by in-vitro fertilization aftergrowing human spermatogonia in a mouse (March 17). Under these rapidly changingcircumstances, the establishment of principles regarding life science and technology is stronglyurged in order to prevent social conflicts.Life science and reproductive technology are being discussed at the Council for Science andTechnology, Science Council and Health Science Council. Discussions will be deepened in thefuture for these problems. We hope our report will serve as a material for these discussions.AcknowledgmentA large number of people have very generously helped in the preparation of this report. Theway in which so many people have given of their time, expertise and advice has been a realrevelation. Especially, the following experts provided us with detailed information andguidance:Shigemi Itohara: Behavioral Genetics Study Team leader at the Brain Science Research Center,Institute of Physical and Chemical Research.Tamiko Iwasaki: Radiation Epidemiology Department manager at the Radiation EffectsAssociation.Moriaki Kusakabe: Genetic Base Research Department manager at Life Science TsukubaResearch Center, Institute of Physical and Chemical Research.Shotaro Kohzuki: Advisor to Mitsui Information Development Co, Ltd. (Visiting researcher atthe National Institute of Science and Technology Policy).Hirohiko Tsujii: Treatment and Diagnosis Department manager at Heavy Particle TreatmentCenter, National Institute of Radiological Sciences.Massaki Hori: Special researcher at Heavy Particle Treatment Center, National Institute of3Radiological Sciences.Toshimitsu Homma: Vice chief researcher at the Reactor Safety Engineering Department,Tokai Research Center, Japan Atomic Energy Research Institute.We would like to thank those who gave generously of their precious time in cooperating withus.In addition, we would like to note that a number of specialists gave lectures at our institute andthat the contents of these lectures will be compiled in a book.4

先端科学技術と法的規制 <生命科学技術の規制を中心に>

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先端科学技術と法的規制 <生命科学技術の規制を中心に>

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National Institute of Science and Technology Policy Library (NISTEP) / 科学技術・学術政策研究所ライブラリ

先端科学技術と法的規制 <生命科学技術の規制を中心に>

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National Institute of Science and Technology Policy Library (NISTEP) / 科学技術・学術政策研究所 ライブラリ

National Institute of Science and Technology Policy Library (NISTEP) / 科学技術・学術政策研究所ライブラリ