Chapter 2 Consensus Development Effort for Regulations
Section 1: Parties Involved in Consensus Development
1. Consensus Development Effort
(1) Consensus Development Effort
As seen in Chapter 1, in the application of life science and technology, especially reproductive medicine and technology, all-out effort may be required in light of its substantial effect on the nation as a whole. Even in European countries, which are on the verge of establishing legal systems regarding the subject, complete consensus was impossible as opinions varied widely.
In Britain and Germany, diverse views were presented in the Warnock report and Benda report, respectively, which were to be the basis for legislation. In France, objections against legislation were raised and examined by the Constitution Court. In Europe, where Christianity prevails throughout the entire society and life of the people, obstacles are expected in forming a consensus about ethics on reproduction, as is so noted in the introduction in the Warnock report.
In the U.S., even a nationwide abortion law is yet to be established, with legislation left to each state, much less a consensus on legislation regarding these problems, indicating difficulty with the issue of life science and technology.
Nevertheless, substantial regulations have been passed regarding reproductive medicine and science in Europe. European countries are said to be ready for applying these laws to cloning technology. Europe's regulatory systems for this problem are highly likely to be adopted as a standard by EU and the United Nations Educational, Scientific and Cultural Organization (UNESCO). Thus, Japan will have to make its stance clear on such regulations sooner or later.
In Japan, strong voices are being raised for regulation on cloning technology, while concerns are growing about excessive restrictions on advanced science and technology.
(2) Means of Consensus Development
Under these circumstances, it is essential at least to make decisions based on varying opinions. The decision making process aside, the following describes desired methods for organizing opinions from different layers of the population so that they can be used as the basis for decision making.
The first problem in collecting popular opinions is deciding <1> from whom, and <2> how, such opinions should be collected. The first point will be handled in later discussion. For the second point, it is important that such opinions should be gathered from as many layers of the population as possible and that active debate should be carried out over conflicting views, thus deepening the understanding of acceptable regulations.
To form a consensus, a number of requirements must be taken into consideration, including disclosure, accountability, education, and the role of nonprofit organizations. Legal restrictions have been discussed in Chapter 1. We will first review two items closely related to these restrictions. The other items will be considered in later sections.
The purpose of collection and discussion of opinions is to provide sufficient data and materials to enable decision makers to make adequate decisions and build a basis for reaching a consensus on relevant regulations by balancing complicated interests among concerned parties systematically and comprehensively. It is desired, therefore, to involve a wide range of parties with different interests in heated debate through symposiums, hearings and other means of exchanging opinions, thus allowing comprehensive judgments. To realize efficient discussion procedures, it is also important to organize and maintain records of past debates so that they can be utilized for later reviews.
This consensus development approached will be examined in Section 2. Instead, this section will focus on which parties opinions should be collected from.
2. Interested Parties
Let us focus in detail on whose opinions should be collected.
In selecting parties to be involved in consensus development efforts, it would be useful to examine a wide range of interests, including those of patients and ordinary citizens. Although it is impossible to include all concerned parties, debate should be based on clear identification of present and latent conflicts of interests.
In our discussion, such parties concerned are classified into three categories: Category 1, composed of those whose interests will be directly related to restriction on research, Category 2, comprising those with indirect interests, and Category 3, with those who are free from such interests but needed in carrying out debate on this issue.
Although, as pointed out in the discussion of Category 2, it is in reality not easy to determine the category to which each concerned party should belong, it would be useful to give typical examples for each category.
(1) Category 1 (Directly Interested Parties)
These parties are those who can lose their rights or interests as a direct result of regulations. As described in Chapter 1, these parties will be entitled to claim their rights or interests by initiating countermeasures such as legal actions. In our discussion, if we extend the definition beyond legal terms, typical interested parties in this category may include the following:
<1> Recipients of technology (Patients, their families, etc.)
These persons, generally including patients, their families and agents, have the results of life science and technology applied to themselves. They should be granted the right to make their own decisions regarding safety, health incentives, and the selection of applications as research results. To respect the rights of patients, declarations of patients' rights have been established. In Japan, informed consent has been discussed with an increasing number of physicians adopting the concept. However, there is no unified agreement among patients and their families with regard to the application of research results, making it necessary to analyze their varying views. In medical practice in our country, there are two types of patients who have or will receive research results.
In selecting a technical application, conflicts can arise among concerned parties. This requires us to be well acquainted with such conflicts in carrying out debates. These conflicts involve:
In addition, conflicts of interests are probable between those who benefit and those who anticipate disadvantages as a result of the application of a new technical method. These conflicts will involve:
In discussing our issue, those positions will require consideration.
<2> Test subjects
These parties contribute to medical studies by volunteering to be tested with a research result before it is directly applied to patients.
Conflicts of interests are also possible between those who have received effective medication (beneficiaries) and those who have been given ineffective drugs (victims), as in administration of drugs and placebos.
<3> Future generations
These parties are members of younger generations who will be affected by the application of research results activities that have been conducted on the present generations. These generations are deprived of opportunities to express their opinions. Thus, it is necessary to have someone speak on their behalf. Deepened discussion will have to be made, however, on whether their parents should be the only party to act for them.
<4> Researchers (Physicians)
Researchers are those who conduct studies on life science and technology and apply the results of such activities to patients and subjects. They are directly affected by legal regulation. Nonetheless, they should not be regarded as always in conflict with patients and subjects, because, as Hippocrates cited in his oath, "You shall be for the good of the sick to the utmost of your power," they are under an ethical obligation to integrate with those to whom science and technology are applied. ("In Britain, women succeeded in forcing the government to legalize abortion by drawing support from physicians," Bioethics Over Life Science, Kiyoko Kinjo.)
This category includes a wide variety of parties, from physicians to advanced medical scientists to researchers working at pharmaceutical businesses. They are guaranteed freedom to conduct research and development activities, including those for new drugs, as well as practicing medicine. At the same time, they are required to provide medical explanations to those concerned, including patients and subjects.
Even these researchers (physicians) will have conflicts of interests among them. For example:
Further, if any researchers conduct studies (and treatment) for the sake of their beneficiaries at their request, conflicts between the beneficiaries and the victims may also be reflected in the relationships among researchers.
<5> Administrative bodies
These parties determine the framework of laws and guidelines for the benefit of the country as a whole, while adjusting differences among competing policies. In addition to safety regulations, they are under an obligation to promote life science and technology related to medicine and work out strategies and policies from a long-term perspective.
(2) Category 2 (Indirectly Interested Parties)
Unlike those falling under Category 2, these parties are not directly involved in social rights and interests. Instead, they are deeply interested in the state of society brought about by the application of technology and express their views, especially through political activities. They do not, however, play a secondary role due to the fact that they are involved only indirectly. Rather, depending on the issue and technology, they may play a far more important part than those in Category 1.
<1> Those who view the state of society from a specific perspective
Although they do not have special interests directly connected to research results and regulations, religious groups supported by a large portion of the population and social activity groups have substantial political influence. In addition, their opinions are frequently presented in a logical, systematic manner. In Europe and the U.S., the strong influence of Christianity is felt across reproductive technology. This is because religious groups, Catholic churches in particular, have a large internal legal system, such as canon law, equivalent to civil law, and a well organized philosophical system, which serve as a global standard. Some civil law systems are said to have been established under these influences. Thus, it is justifiable to involve these parties in our discussions.
<2> Ordinary citizens
When making decisions on our issue, it is necessary to collect opinions from a wide range of citizens. It is difficult to define citizens and the category they should belong to. They may fall under Category 2 or Category 3. Or they may require a different category. For convenience, they are classified into Category 2 in our discussion.
Generally, citizens are not directly concerned with life science and technology, that is, they are not researchers nor are research results applied to them. They are non-specialists without special knowledge. In establishing scientific and technological policies, there will arise more opportunities to ask for opinions of citizens. The requirements for a citizen are unclear, compared with those for the parties falling under <1> to <5> of Category 1. The problems include:
As seen above, it is extremely difficult to define the scope of a citizen. There are varying views over measures for forming a consensus involving citizens. It is hoped that discussion on the definition of "citizen" will be deepened by examining these cases individually.
In debates on reproductive medicine and technology in Europe and the U.S., few parties seem to have been chosen as citizens by various committees. Depending on the subject, civil participation may be extremely difficult. (Citizens have two functions: participating in politics and administration, and presenting a wide variety of views not available from interested parties. Extensive studies have been conducted on the former function in connection with general problems including application of science and technology. Our discussion will focus on the latter function, especially with respect to application of results of life science studies.)
(3) Category 3 (Neutral Parties)
These parties, who are not classified into Categories 1 or 2, are experts who hold neutral positions free from interests, and thus should be asked for opinions.
<1> Researchers without direct interests
These are parties who are exclusively engaged in a field of study including the type of studies which will come under regulation but whose studies themselves are not involved in such regulation. With their studies not restricted by the regulations, they are in a position that permits them to present their views based on their professional knowledge and experience.
<2> Peripheral researchers
These are researchers and intellectuals capable of expressing their views based on their professional knowledge and experience with respect to the field of study that covers the studies to be restricted.
Such parties will include:
<3> Intermediary experts, etc.
Experts in consensus development who are capable of explaining advanced scientific knowledge to subjects and the public. With increasing demands for accountability on science and technology policies, diversifying opportunities for discussion are likely to appear in the future. More experts will be in demand in line with this trend.
3. Anticipated Problems with Interested Parties (Cloning Technology)
(1) Typical Interested Parties
Our discussion so far has been concerned with those who should provide us their opinions in reviewing regulation issues related to the application of scientific and technological results. The discussion has focused on conflict of interests among various parties, as well as categorization according to their admissibility. The section to follow provides practical examples to make clear the way selection of interested parties should be made.
As in Chapter 1, our discussion focuses on cloning technology in connection with legal restrictions. Our first concern is which parties desire regulation of research activities in cloning technology. Those who want to have a cloned baby by presenting their body nuclei and physicians and researchers are directly interested persons. Women who present their fertilized or unfertilized ovum to have it implanted in their uterus have also similar interests in regulations.
On the other hand, opposition to views of subjects, physicians and researchers, who would support cloning technology, would be raised by those who view the state of society from a specific perspective, who are in Category 2. In Europe and the U.S., these oppositions are clearly propagated by Christian-oriented religious groups, while, in Japan, no distinct groups are present as opposition parties. The absence of such parties may reflect the fact that, in Japan, no strong voice has been raised against the promotion of cloning technology, with little discussion carried out on the subject. Clear, logical opposition is essential not only to have supporters to clarify their justifications but also to balance both sides, although too much opposition may obstruct consensus development, as was seen in the U.S.
We should not rely simply on citizens for opposing views. Instead, it is desirable to absorb opinions of those in Category 2 (well organized public opinion polls are highly useful tools), and reconstruct them systematically so that they can be used in discussions on regulations.
(2) Example of Opinions on Cloning Technology
At the end of this section, we should list opinions, just for reference, which would be heard among interested parties described in the preceding paragraphs with regard to restrictions on reproductive technology.
(i) Category 1
a. Recipients of Technology (Patients)
Those who are willing to present their body nuclei would claim the following rights and interests:
<1> Infertility treatment based on the decision of an individual as with artificial insemination and external fertilization.
(To the question, "What do you think about the application of cloning technology to enable childless couples to have babies with genes of either the husband or wife without normal fertilization?" in "Survey on intellectuals regarding cloning technology," conducted in September 1998 by the Cabinet Public Relations Office, 67.3% of the 2,114 subjects responded that the technology should not be applied, while 22.0% said they would approve such technology if there is no other means of having babies and if it is conducted on certain conditions, including authorization by an investigative organization.)
<2> Opportunities for males with azoospermia and those without the ability to produce sperm to have babies.
<3> Right of females to have babies without male interference.
<4> Right to make one's own decision in preserving one's genes in a perfect form.
On the other hand, the interests of those who use body nuclei provided by other persons might include:
<5> Reproducing babies from the body nuclei of their dead children.
b. Subjects
If those offering the use of their uterus are considered to be subjects, they would claim:
<1> The right to bear babies as with a surrogate mother, even if the newborns do not belong to them.
<2> Parental rights to newborns, as with a surrogate mother.
c. Researchers (Physicians)
Some researchers (physicians) desire the application of cloning technology on the basis of their belief in free academic activities, while at the same time being tempted to implement it at a strong request of patients. (The patients' position has been discussed above.) They would assert:
<1> Research activities not aimed at human cloning should be permitted for the sake of the welfare of mankind.
<2> With some scientifically advanced countries where no restrictions are established, Japan is likely to lag behind them in para-cloning technology, such as reproductive medical technology.
<3> Even if regulations are imposed domestically, some Japanese researchers would conduct such studies overseas so long as there is demand for the technology.
<4> Cloning technology is not against their ethical and religious beliefs.
According to the previously mentioned "Survey on intellectuals regarding cloning technology," four percent of the 2,114 subjects surveyed responded with an affirmative answer to the question, "Is it desirable to apply cloning technology to humans?." Their justifications included (Multiple answer):
<1> Even if they are produced by cloning, humans can change in characters, such as ability and appearance, according to circumstances where they are brought up, so that there are no grounds for seeing human cloning as a special evil. (58.8%)
<2> The characters of a cloned baby are largely predictable by judging its parents because it is produced through interaction between the sexes, so that there is no need to be concerned about cloning technology. (40.0%)
<3> The production of more superior humans would contribute to the advancement of human society. (22.4%)
<4> Human cloning is a result of the advancement of science and technology, a sort of thing that cannot be stopped. (29.4%)
<5> Others. (12.9%) Undecided. (2.4%)
(ii) Category 2
As formerly mentioned, the presence of groups who view the state of society from a specific perspective is not so conspicuous in Japan as in Europe and the U.S. In addition, the definition of "citizen" is unclear. These factors make it difficult to collect a sufficient amount of opinion.
In the same survey above, 1,976 respondents, or 93.5% of the 2,114 subjects, agreed to the notion that the application of cloning technology to humans is not adequate for ethical grounds. Their reasons in multiple answers included:
<1> The application of the technology to humans would impair human dignity because the production of humans should involve both sexes. (67.7%)
<2> Human cloning treats humans simply as a means of achieving predetermined purposes rather than creating free individuals. (43.6%)
<3> It should never permitted to predetermine the characters of a human. (29.8%)
<4> There is a possibility that a society might be created where a priority is placed on producing humans with superiors characters. (26.1%)
<5> There is a possibility that social discrimination might arise between naturally born humans and cloned humans. (14.9%)
<6> Cloned newborns are not guaranteed safe growth. (10.0%)
<7> Others. (4.6%) Not decided. (0.3%)
To the question, "How regulation on human cloning should be implemented in Japan as compared with foreign countries? Choose one answer," the 2,114 subjects surveyed answered
<1> Japan should keep pace with other countries. (42.8%)
<2> Stringent regulations must be imposed, independently of other countries, to prevent unrestrained development in the technology. (38.1%)
<3> Whether stringent or lukewarm, such regulations should reflect the real state of Japan. (13.7%)
<4> Regulations should be loose enough to encourage research activities. (1.9%)
<5> Others. (2.0%) No specific idea. (0.3%) Not decided. (1.1%)
The findings of this questionnaire suggest that those classified as Category 2 hold affirmative ideas about regulating cloning technology.
The opinions provided here represent typical opposing views prevalent at present. It is necessary to create more opportunities for exchanging opinions in an active manner, thus accumulating a substantial amount of concrete views.