Section 6: Grounds for Justifying Regulation (with Primary Regard to Cloning Technology)
1. Types of Hazards Caused by Application of Cloning Technology
In this Section, the authors will investigate the reasoning behind regulation. If we try to investigate grounds for regulation (e.g. assuming that a penal code be selected for regulation, we need to investigate which of the legally protected interests would then be violated), we have to identify dangers and harms caused by individual technologies and therefore, we cannot investigate merely by generalizing technologies under the headings of life sciences or reproductive medical technology, which so far has been done in this Report. Instead we have to investigate a strictly limited area. Accordingly, as described at the beginning of this Report, the authors will focus on cloning technology only in this Section and discuss the other technologies as far as such discussion is necessary for comparison with cloning technology.
(1) Hazards to Mothers who Deliver Babies
Transplanting a nucleus to an egg and implanting of the egg into the womb of the mother may cause hazards to the health of the mother. The mother's life and body should be protected. Hazards to the mother's health clearly violate the legally protected interests of the individual as well as negatively affects the benefits of the individual. It is therefore considered that protecting the mother's health raises no special problems. If cloning technology should affect the safety of the mother, there will be no problems caused by regulating and prohibiting application of cloning technology to such cases.
A report issued by Science Council points out the following safety-related issue as grounds for justifying regulation:
(2) Hazards to Babies Born
When a nucleus is transplanted to an egg to create an embryo and that embryo is then implanted into the womb of the mother, the baby to be delivered of the mother may suffer from many hazards to his/her life and body. Firstly, the egg in itself was not originally capable of bringing about the formation of an embryo, but as a result of the manipulation was later born as a baby; accordingly, it is understood that nuclear transplantation produced some change or damage to the egg as compared to its original status. Another reading of the situation is that if the egg is considered as an controllable object separate from the body, then the egg in itself was subjected to damage, and thus it can be considered as destruction of things. (The authors introduced in Section 3 that scholars in penal law point out the necessity of establishing new legislation, because under the currently effective laws, fertilized eggs can only be treated as things.) Secondly, even if due to incompleteness of technology or for any other relevant reasons a baby is not born or is born with abnormalities, the child (or the fertilized egg produced by normal pregnancy that is supposed to form an embryo which is later born as a baby) will not suffer from danger or harm. It is hardly considered, therefore, to establish a legal framework that punishes individuals who are engaged in nuclear transplantation, on the ground that the safety of life and body of fetuses is legally protected. At present this ground is applied to the crime of abortion.
Even assuming that an egg to which a nucleus is transplanted be regarded as identical at the time of nuclear transplantation as the fertilized egg produced by normal pregnancy, fetal death or abnormality caused by cloning technology cannot be regarded as damaging to the life and body of the child, i.e. violation of the legally protected interests of the child, since application of cloning technology is unavoidably associated with occurrence of such fetal death or abnormality.
On the other hand, the thought that hazards posed to the baby to be born are regarded as a violation of the legally protected interests of the child or of the benefits of the child can be based on the view that an act itself of bringing about the delivery of an abnormal child is a violation of the legally protected interests of the social order. According to this view, however, (i) when a baby is born dead, none of the legally protected interests are damaged, but (ii) an act of bringing about the birth of an abnormal baby corresponds to a violating act. These two may cause eugenic problems.
In light of the above-described points also, the safety of the baby to be born, together with genetic effects described in the next section, has to be evaluated in connection with a higher and abstract level of social risk.
(3) Hazards in Connection with Genetic Effects on the Next Generation (i.e. Children) and Subsequent Generations
Since the somatic cells differ from the reproductive cells in function, genes of the somatic cells may be resistant to chromosomal alterations by external forces, e.g. radiation. It is therefore understood that a number of damaged (altered) genes exist in somatic cells, without affecting their function. However, when transplanting these somatic cells for the purpose of cloning, in theory, a damaged gene which may exist only in that single somatic cell out of all the cells of the body of the "parent" will ultimately be shared by all the cells of the entire body of the "child": the damaged gene in question may therefore have an enormous influence on the child. At present, it is considered difficult to identify such gene damage in advance among the multitude of genes within the somatic cell and it is therefore difficult to obtain the original (fully intact) genes as in the case of reproductive cells (note that reproductive cells are strongly sensitive and will die when their genes are damaged).
Genetic impact inherited by genes is expressed in terms of probability but it is difficult to foresee specific damage. In addition, genetic impact in many cases cannot be confirmed until knowledge and findings have been accumulated over many generations. In the human population, it is accepted that impairment caused by hereditary disease naturally occurs in approximately one of every 100 persons and that of having genetic predisposition for a disease (e.g. diabetes mellitus) is much higher, at approximately one of every 10 persons. Regarding hereditary diseases, there is a strong tendency in Japan to keep them confidential, which hinders gathering of relevant data, and responsive actions taken are passive. In contrast, European and North American countries have a very high interest in hereditary diseases, and the responsible agencies perform diagnosis of hereditary diseases and take responsive actions.
In Japan, the Japanese Association of Gynecology and Obstetrics issued the Association's recommendations entitled "Opinion on Fetal Diagnosis for Inborn Errors, with Special Regard to Early Examination of Villus" (in 1988) and "Opinion on Pre-Implantation Diagnosis" (in 1998). The Japan Association of Anthropology and Heredity established "Guidelines Concerning Genetic Counseling and Pre-Birth Diagnosis" (in 1994) and "Guidelines Concerning Gene Diagnosis for Hereditary Diseases" (in 1995). Regarding diagnosis of genes in fertilized eggs in particular, application for the first case of this diagnosis was recently made to the authorities in Japan.
It is necessary in Japan to deepen people's understanding to the same extent as in European and North American countries regarding actions to be taken to cope with hereditary disease. On the other hand, it is considered easier to obtain people's understanding regarding regulation of causes which bring about artificially induced hereditary effects. It is also considered reasonable to regulate such causes for the sake of preserving people's health since there is the possibility that such causes may result in large-scale, unforeseen damage. When evaluating the application of cloning technology, we cannot ignore these artificially induced hereditary effects since manipulation at the level of the gene is performed. In addition, as described above, unlike artificial insemination and in vitro fertilization which use highly sensitive reproductive cells (i.e. if a reproductive cell has damaged genes, then the reproductive cell will die, according to which adverse genetic effects are not likely to be inherited) or nuclei of the reproductive cells, cloning technology uses poorly sensitive somatic cells (i.e. even if a somatic cell undergoes gene damage due to ultraviolet light or radiation, it is most likely that the cell itself will survive and continue to play cellular roles) and transplants the nuclei of these somatic cells. Cloning technology may thus inadvertently pass on hereditary effects onto subsequent generations and thus extreme caution should be exercised in handling cloning technology. For example, a differentiated epidermal cell with gene damage, within the tissues of the human body surface, is unlikely to have any adverse effect on the rest of the body; in contrast, removal of the nucleus from this particular somatic cell with gene damage and transplantation of the nucleus for the purpose of creating a cloned human baby introduces the possibility that the cloned human baby thus created may have identical gene damage in all the cells of the body: as a result of this, extremely serious effects may occur both in the cloned individual and his/her descendants.
Despite the possibility of producing such serious effects, the risk of producing hereditary adverse effects is considered not as a specific danger but an abstract risk, which makes it difficult to set requirements or standards for regulations. In Japan, regulations were imposed on nuclear energy-related matters from the viewpoint of genetic effects. The authors would like to proceed with our investigation by referring to these regulations in the field of nuclear energy. Regulation of genetic effects is evaluated in connection with violation of the legally protected interests and benefits of society and from the viewpoint of probability, and therefore, hazards posed to the child to be born can be also taken into account.
As described above, the authors only introduced examples of easily understandable gene damage in this section. Science Council lists the following as important safety-related matters in connection with genetic effects in particular:
The Committee additionally lists, among others, genetically consanguineous marriage due to use of frozen/stored eggs and a possibility of rapidly losing genetic diversity in the human population. These additional matters are excluded from our investigation since they are far away from the direct genetic risk.
2. Regulation from the Viewpoint of Genetic Effects Caused by Radiation
(1) In connection with research of genetics, research of genetic effects caused by radiation has been actively performed since many years ago as causes to be given can be identified quantitatively, and the field has produced substantial achievements. International organizations regarding research of radiation induced effects, the UN Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) and the International Commission on Radiological Protection (ICRP), also evaluated various types of physical impairments as well as genetic effects attributable to radiation and set standards. Among these standards, the ICRP set the standard citizen's genetic dose (this is currently referred to as collective dose) in PUB6 (Publication 6). This is based on the view that "appropriate projects regarding nuclear power plants and the other large-scale peaceful uses of nuclear energy will require limit exposure to the entire population firstly by limiting dose exposed to the individual and secondly by limiting the number of people to be exposed." By focusing on the 'maximal permissible genetic dose' and separating exposure attributable to natural background from medical exposure, they concluded that the genetic dose derived from all sources to the population should not exceed 5 rem and recommended 2 rem as an allocation after excluding the reserves (refer to Reference 2 for details).
(2) In Japan, the Nuclear Reactor Regulation Law prescribes that the Atomic Energy Commission shall examine application for installation of a reactor and grant a license for the installation. The guidelines for examination of reactor locations that is used upon examination of the safety of the reactor concerned stipulate that "the site for the reactor concerned shall be away by a required distance from dense population areas. The required distance from dense population areas means the distance far enough to reduce, in a hypothetical accident, an integrated whole body exposure dose to such an extent as fully acceptable from the viewpoint of the standard citizen's genetic dose" (decided by the Atomic Energy Commission on May 27, 1964). (Subsequent review of the atomic energy administration decided that the Nuclear Safety Commission will examine safety of reactors and accordingly, the guidelines for examination of reactor locations were handed over to the Nuclear Safety Commission.) Furthermore, according to a report issued by the Special Task Group on Reactor Safety Standards that established the above-described guidelines, the dose that should be reduced was set at 0.5 x 108 man.rem.
(3) As described above, despite the fact that none of the laws expressly and directly establish dose limitation, the currently available system is to limit population exposure dose not only for the purpose of preventing the individual from directly suffering from radiation damage but also inhibiting genetic effects.
Regarding limitation of population exposure, the ICRP states that "this limitation unavoidably implies compromise between harmful effects and social benefits" and that there would be no fixed standards. The ICRP continues to state that "factors influencing balance between dangers and benefits may vary depending on countries and each country should assume responsibilities to make the final decision regarding this issue" and accordingly, that the value indicated should be regarded as the "tentative upper limit."
(4) Finally, when limiting population exposure dose, the ICRP allocates the exposure dose as indicated in the table below. Reference 2 shows the underlying thoughts contained in the guidelines for examination of reactor locations.
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<1> Natural background level <2> Medical exposure <3> Occupational exposure, etc. <4> Exposure to the population as a whole <5> Long-term reserves |
The recommendations recently issued by the ICRP contain no statements regarding the maximum permissible genetic dose. The Commission currently is based on the concept of collective dose and primarily focuses on limitation of carcinogenesis risk.
3. Methods of Regulating Cloning Technology
(1) On the basis of the above-described fact that genetic effects attributable to radiation were limited through the use of the standard citizen's genetic dose, it may be possible to restrict cloning technology for the purpose of preventing genetic effects related by implementation of cloning technology, e.g. transplantation of a somatic cell's nucleus to an unfertilized egg.
The point of such restriction is "what should function as the quantitative condition in restricting cloning technology?" In the case of radiation protection measures, the standard citizen's genetic dose is the quantitative condition. Some argue from the viewpoint of scientific technology that the genetic effects not only attributable to ovum manipulation but also to various chemical substances should correspond to the radiation equivalent. There exist many difficulties, however, since the phenomena related to cloning technology is not as simple as the physical phenomena related to radiation.
(2) Firstly, it is considered that when the ICRP issued the recommendations, they did not have clear knowledge or grounds for the genetic effects attributable to radiation but they evaluated the balance between benefits and risks resulting from utilization of nuclear energy and proposed that permissible dose. Accordingly, as far as specific advantages obtained from application of the technology concerned are not recognized by the society, it could be possible that no quantitative regulation be imposed on that technology but instead no application of that technology be approved (i.e. application of the technology concerned will as a rule be prohibited).
Special attention should be paid to the fact that when the ICRP issued the recommendations, radiation was the known cause of bringing about the greatest genetic effects. Since it was considered that new scientific findings would probably not be obtained for a while, it was significant for a nation to indicate the certain standard, even if that level was not a fully established one, and to ensure that people follow that standard because the nation takes responsibilities of protecting the life and health of its citizens.
(3) Secondly, evaluation of the structure of regulation built by the guidelines for examination of reactor locations (and the ICRP's recommendations) may indicate that {<1> natural background level} corresponds to damage of our genes which we unavoidably suffer from during our daily lives (it is considered that even if there exist no special causes, humans possess and accumulate harmful genes). What correspond to {<2> medical exposure} are in vitro fertilization and various technologies supporting pregnancy, the effects of which should be permissible as far as they are properly controlled, according to the same idea employed for the radiation protection: these technologies are therapies for infertility and we can accept their advantages. The authors will omit discussion about {<3> occupational exposure} since nothing corresponds to this. Cloning technology corresponds to {<4> exposure to the population as a whole}. At present, we cannot think of any direct and evident advantage resulting from cloning technology. In the case of nuclear power plants, the advantage that we can share is to secure good-quality energy in a stable manner. We therefore need to compare possible advantages with {<5> long-term reserves}, which should be held in reserve to cope with unforeseeable future effects on us and our descendants due to, for example, radiation, environmental changes and chemical substances contained in foods, in order to determine the extent of acceptance. The authors think it is possible that as a result of such comparison, application of cloning technology causing the genetic effects corresponding to <4> and <5> be totally prohibited.
(4) In light of the above-described points, it may be acceptable to regulate cloning technology from the viewpoint of its risks. Cloning technology is associated with impairments at higher probabilities as compared to in vitro fertilization, gene diagnosis, and gene therapy, which are considered similar types of technology as cloning technology. Even if the risk of such impairments at higher probabilities is compared with advantages from cloning technology, it is considered acceptable that cloning technology be differentiated from the other similar types of technology and be regulated accordingly.