Interactive bioethics in a focus group on life and biotechnology in Japan


Human Genome Review 15 (2001) 173-201.
Author: Fumi Maekawa and Darryl R. J. Macer

Institute of Biological Sciences, University of Tsukuba, Japan
1. Interactive bioethics

The recent advances in technology have made our life convenient, and at the same time, posed us with more dilemmas. Bioethics helps us solve such dilemmas. It has been encapsulated within philosophy, sociology, ethics, medical ethics and science. Ancient bioethical dilemmas include choosing when and how to reproduce and die, and how much altering of nature we accept. Bioethics includes any issue that touches life; therefore it is essential that we look at these problems from a bioethical point of view.

There are three main approaches to bioethics, prescriptive, descriptive and interactive bioethics. Prescriptive bioethics is to tell others what is ethically good or bad, or what principles are most important in making such decisions. Descriptive bioethics is the way people view life, their moral interactions and responsibilities with living organisms in their life. Interactive bioethics is discussion and debate between people about descriptive and prescriptive bioethics.

People's opinion is not something to only describe as a static point, rather we live in a fluid society and we form our views by an ongoing process of interaction with others. Development of different life views when confronted with moral dilemmas has become a major issue in public discussion of the ethics of science and technology, and in the formation of policies. Participation of the public in the societal decision-making process regarding new technology, is not only a question of knowing what is going on, but for a new technology to be accepted by the public, it is crucial to perceive the choice and influence. A persons' bioethic is developed based on their own and other people's opinions that grows as we face various dilemmas through our life. To have a balanced opinion from the community, it is important to hear from persons in a range of positions with different occupations. This common social goal has developed hand in hand with the emergence of increased media attention in pluralistic democracies to display the divergent views on science and technology.

Discussion and exchange of ideas is crucial for interactive bioethics, not only when building a consensus, but also in daily life activities. We all are influenced from our environment, background, and the work we do. Some persons may have more specialized knowledge than others, while those outside of a specialized area may have a view that specialists have never thought of.

One way to get to know what people think, and how they process the various opinions they hear about biotechnology, is through a small group that focuses on one issue. There have been various uses of small group discussions, and focus groups, in some previous studies. One use of small groups is in public opinion studies, consumer research, and in policy making. Longley and Iredale suggests that "The principal aim of focus group research is to elicit expressions of the views, experiences, opinions, feelings, beliefs and perspectives of participants in their own words" which we have also tried to aim on.

We want to present some results from discussion in what we have named the "Life and Bio Think Group" in Japan. This was a focus group that met together in Tokyo to discuss questions facing our life raised by biotechnology. Japan has a long history of biotechnology in fermentation of food and drink, and in a 1991 survey, it was shown that 97% of people had at least heard the word, the highest of any country that has been surveyed in the world. Public opinion surveys suggest that the most significant event concerning public attitudes towards biotechnology in Japan is the introduction of GM food to the market. In the past three decades, there have been major debates about brain death, and organ transplants from brain-dead bodies in Japan. Japan has been enriched by biotechnology, but with the exception of brain death, there has been little debate about the bioethical implications of technology. There might be several reasons for this, including the lack of information given to the public, and the little flow of their opinion back to the main bodies introducing the technology, due to the paternalistic structure of Japanese society.

2. Focus Groups and the Life and Bio Think Group

The Life and Bio Think Group was formed in April 1999 and met 12 times until July 2000. Most members were working, and in a range of fields including government, industry, media, academia, farming, and self-employed persons. Everyone was given a chance to speak at every meeting in an informal atmosphere. The discussion themes included:

  1. GM food and labeling (meetings 1-4)
  2. Intellectual property and life, and farmer's rights in the age of biotechnology (meetings 5-6)
  3. Human dignity and reproductive cloning (meetings 7-10)
  4. Organ transplantation (meetings 11-12)
Since one purpose of this research was to look at how people build up their thoughts, listen to other people's opinions and information, and assimilate this to develop their views, full attendance of every member is the ideal for this type of focus group. However, due to schedule difficulties, not every member could attend all meetings. In order to facilitate the process of critical reflection, the minutes of every meeting were circulated to all members after the meeting was held. From the third meeting, a tape recorder was used to help prepare accurate minutes, and no member objected to it.

In all cases, we started the discussion by asking members to point out what kinds of issues or image they had on the subject. Next, we picked some of the major points that all members showed interest on, and focused on those points. The meetings were informally chaired to encourage everyone to speak. For meetings 1-2, 4-7, Ms. Izumi Ohtani, a high school ethics teacher was the chair. For meeting 3 Ms. Yuri Oiwa, a newspaper editor chaired, and for meetings 8-10, and 12 Fumi Maekawa was the chair, and for meeting 11, Ms. Makina Kato, a bioethics doctoral student in our laboratory chaired.

Two statements have been developed from these meetings, one on GMO Labeling Policy in Japan, and the second on Human Cloning. The two statements represent summaries of the discussion, and by coincidence both themes were discussed for four meetings. In the case of GMO labeling, after the third meeting we proposed the first draft of the statement, which was circulated among members through e-mail and fax. In the case of cloning, this proposal came after the second meeting. Members were asked to give their opinion on items to include in a statement, and the first draft statement we made. Then the comments received and further ideas were discussed at the following meeting, which were included in the second revised statement. After this revised statement was made, it was again circulated to members to ask for further comments. The last day of discussion was to make the final version of the statement and discuss any additional points. In the case of GM food and labeling, there were many comments so the total process required three drafts, but for cloning less members made comments so only two drafts were required. Members were asked to agree to sign their name under the statement, and most did so, as discussed below.

3. Statement on GMO Labeling Policy in Japan and meetings 1-4

The issue of GMO labeling has been particularly controversial since 1997, and there has been a significant drop in public support for GM food in Japan between 1997 and 2000. Because of the divergence of strongly held views, it is difficult to get real dialogue over this issue in a public forum. Considering this background, the group has functioned very well as a discussion forum. However there was still hot discussion at the second meeting when a leader of the "No to GMO food campaign" and another environmental activist attended, because they both had very forceful and strong views which they wanted to share with members. Their comments helped members get a fuller perspective, however it was difficult to dialogue with them. For a focus group to work well, every one has to be able to listen with open ears to others. In fact, these persons did not attend future meetings, but sent detailed comments on the draft statement. However, although some of their points were included, they did not want to sign the statement.

The first meeting had a lively exchange of view, as if people had been waiting for a chance to share their thoughts on this issue. Therefore we asked members to try to focus discussion through specific questions, as there are many issues associated with biotechnology. As well as discussion, we also asked several new members to give specific background on some topics for the second meeting. The background presentations for 5-10 minutes were 1) What new gene or protein does Bt corn or herbicide-tolerant soybean have in it, by a manager of Novartis Seeds, 2) What is product based regulation of GMOs, by a chief in the Ministry of Agriculture and Forestry and Fisheries (MAFF) section on GM foods, 3) What are the advantages of organic foods and what types of pesticide are dangerous by an organic farmer, and 4) Results of public opinion surveys on concerns people have with foods, by Darryl Macer. These background presentations were followed by active discussion.

Meeting 3 continued this interaction; discussing issues like the limits of labeling of GM free food, and developing a list of items those members thought could be included in a statement. For the agenda of meeting 4, we asked members to discuss the new guidelines proposed for GMO labels that were issued by the MAFF on the 10th August 1999. This focused the goal to make a consensus statement on the guidelines.

The planned guidelines, which came into effect from April 2001 in Japan, proposed three sets of labels for foods that are substantially equivalent to existing food. 1) Genetically modified and not segregated, 2) Genetically modified and segregated, and 3) Not genetically modified and segregated. However about 90% of the GMO food does not fall into the categories where labeling is required, including things like soy sauce, corn flakes, oils, and frozen potato products. Unavoidable and unintentional mingling of GMO into identity preserved (IP)-handled ingredients (0.5% for strict IP handling and 5% for bulk IP handling) does not constitute false labeling, as long as appropriate confirmation through documentation is provided. There is an exemption for those who sell products manufactured at the same place, e.g. farmers selling products at their own roadside shop.

In the fourth meeting, a number of ideas were shared and to aid discussion, these were written on a marker board. Following are the problems that were discussed and some of the comments given. To the problem, "Who will be paying the additional costs for contamination tests?" the comments included that when it becomes too much for the company, then it should be reflected in the price of the product. There were doubts if any system existed to check this. At the moment, too much is asked for consumers to do, and that the government presumes all control systems are working. The feeling of safety depends on people's feelings to existing food, which could be compromised by more knowledge. But the problem still lies in the fact that there are very few specialists on this matter. Also there was a mention of the difference between Japan and EU, where EU is trying not to import crops, but Japan cannot survive without imported goods. Complaints over the role of government rose as "They only move after a big fuss". Here, the role of education was questioned. There is a tendency in the Japanese style of education to be critical of problems, but we need to balance merits and demerits in teaching this type of issue. Another big problem was the need for interdisciplinary discussion and its dissemination to the public. Different data is used in different situations, and its interpretation varies between people. Discussion that shows scientific proof is ideal, but again, there are limited personnel to discuss these topics. With regard to information dissemination, researchers are usually not good in telling people about their specific field. Therefore, the media should be a bridge between researchers and people.

Overall, the group thought that consumers might be easily influenced by media and while they might not be so interested, we should keep on giving out information for proper understanding. There fore we developed the statement. The statement given in full in Appendix A, has been approved by 14 members, both in English and Japanese. We will discuss the background to some articles following the relevant text of the statement article below:

1. We emphasize the need for an open and transparent process of the introduction of novel foods and products to our daily diet. This responsibility is shared by scientists making the new varieties, seed companies and suppliers, farmers, transporters and agents, food processors, and retailers.

This point was made first in the statement because many of the members thought that the information given from the government was not clear enough, and that people did not have enough opportunity to examine about GMOs.

2. There has been extensive research on the environmental and human health issues rose by GMOs and genetically modified foods since the 1980s. Until now there has been no concrete case of human health suffering from consumption of genetically modified foods themselves. However, research should continue on commercial scale releases.

This point was important to make because there are confusing rumors repeated by protest groups about studies or health problems, which are not due to eating GM foods, for example the Showa Denko case on consumption of tryptophan

3. There has been much conflicting information on the issues raised, and the responsibility for this rests with the persons speaking in the media and the media selection of information. The media should be the bridge between researchers and people. The media should carefully consider whether the information provided is accurate, and if it really helps consumers make informed decisions.

A few members belong to the media, and felt the responsibility to share clear and balanced information. There was some debate that people who were interviewed to comment on GMOs were limited to specific persons. Still the media is trying to cover both sides, supporters and objectors of the topic, and in this case, the media had difficulty in finding a specialist, both on the supporting side and on the objecting side.

4. There should be long term monitoring of the use of GMO crops for environmental concerns, and this can be accomplished with cooperation between seed companies and farmers.

This still leaves the possibly unanswerable question, how long is long term monitoring, and to what extent should the testing be done.

5. It will be very difficult to monitor long-term health effects of genetically modified foods because every person already eats so many different foods, many of them are known to have health risks exceeding any potential risks posed by foods which contain components made from genetically modified organisms. For example, many everyday traditional products such as grilled fish and meat, beverages, sauces, contain known carcinogens, but these products are not tested. However, decisions should be made on a case-by-case basis considering international practices and recommendations of Codex Alimentarius.

To some members, it was shocking to accept that any food could become harmful, and that there was always some risk. Why do we feel it is safe to eat the traditional food that we have consumed? Is it because we have never questioned its health risks? If we question the risk of a GMO, it might be more consistent to question about the risk of other food that we consume daily.

8. We consumers should have access to all products in our community even though individual supermarkets may stop selling certain products, to exercise market choice. Ideally supermarkets should display the products side-by-side to allow free choice of consumers.

One of the participating members is the secretary of the Japan Consumers Union, and a leader of the No to GMO campaign, discussed above. She thought this statement was nonsense because it was obvious consumers would never buy GM food if they had a choice. However, other members of the group preferred to consume GM food, and want a choice.

11. The verification of not genetically modified segregated label is the most difficult to proof, and there should be penalties for false labeling of food as "GMO free." We want the penalty system to be clarified, for example will violations be imposed under the JAS penal regulations or another system? The difference between strict and bulk identity preserved IP handling that is used to define the proposed exemption levels should be clarified. How will the consumer know? The proposed exemption levels should be developed consistent with international standards.

The Japanese government has suggested a tolerable limit of 5% GM contamination in bulk handling for food to be labeled GM-free, and 1% contamination for strict IP handling. There is a need for international standardization of these levels. Otherwise producers will have to have varied standards for each country.

13. It is not always true that there is more comfort with more knowledge, but we live in an informed society and people should have access to extra information if they wish it. A practical system should be introduced and we propose that one reliable and standard information site on each product should be made on the Internet by an independent advisory group, possibly to the MAFF/MHW in cooperation with companies and consumers. This would lessen the conflicts between different data so that people could trust someone. Both positive and negative information should be presented.

Information flow has two sides, the provider and the consumer. Even if information is provided, it is still unclear if people will use that information. The silent majority may not be interested, however, we still have a duty to produce understandable information. Sometimes people can be stimulated to think about these issues more if they see it is associated with someone or something more familiar to their daily life.

15. There should be a system established for prevention of risks in the event of any accidents, or unforeseen events, with clear responsibilities assigned. This type of incident may occur in growing the crops, so seeds and seedlings should be labeled clearly for farmers, and monitoring should be coordinated between production and consumption systems.

For seeds this may be possible, but one member considered it difficult to label seedlings. However it is not impossible, it is just a matter of keeping the cost increases due to identity preserved handling to a minimum.

This statement was circulated to media, industry, and government in Japan, and may have had some input to the final MAFF guidelines that were implemented from April 2001. We also received positive feedback from some European industry groups in England and Belgium.

4. Meetings and Development of a Statement on Human Cloning

For meetings 7-10, we discussed human cloning. For this topic, the majority of participants were female, because some male participants, who had been very interested in the GMO labeling issue, did not continue to regularly attend. We started the discussion of this topic by everyone mentioning his or her image of "clones". Some people thought that the technology itself is like Science Fiction. In the past there has been many novels and comic books written about cloning. This fact and the birth of "Dolly" made cloning, which is not an unusual phenomenon in nature, seem like Science Fiction. Identical twins and trees bred by cuttings are readily examples of cloning that, maybe because they have no artificial image.

Some of the key topics related to cloning that were raised during the discussion were:

Organ transplants have become another medical treatment people can choose since the 1980s, although quite controversial in Japan. Behind this is the chronic lack of organ donors.

One member said that to break through this situation, technologies to make human organs in other animals like pigs are now being researched. To do this, h-daf gene is inserted into the pig's gene, which then will grow up to have organs containing h-daf gene that human immune system will not identify as an alien substance when transplanted, hence it does not get attacked. The reason why pigs are favored to make organs for transplantation is mainly because of the biological similarity between pigs and humans. Not only because pigs' organs fit humans, but the fact that pigs have long been eaten and raised by humans as cattle, makes it easier for humans to accept the killing. Considering immunocomptability, the best organisms to obtain organs for transplantation to humans are other apes because we are the most closely related species. Still, society would not accept the killing of apes to extract organs from moral reasons, and there are fears of retroviral infection, like HIV. Also, all members thought that pets such as dogs and cats would not be a target, not because of their size difference but because they are loved and thought of as humans' partner. At this point one person asked whether it was ethically correct to make clones just because it produces good organs for transplantation, and as a result, kill many animals. People seemed to be more hesitant to kill animals closer to human beings.

One person mentioned that there are quite a number of people who jump to bad images when the word "clone" is mentioned. This is, for example, seen in questions such as "Is there going to be another Hitler?" or "Will there be cloned humans for military use?" This was mentioned earlier, but we can assume that there is great influence from Science Fiction novels and comic books, which are very popular in Japan. Because of these images, depending on people there are very negative attitude towards cloning technology.

While discussing images of clones, one person questioned how science and technology in general is accepted, where is the line not to accept, and what factors affect the acceptance. To give a recent example, genetic modification seen in GMOs was clearly a technology that many in society question. Eventually, technological innovation only proceeds in the direction society permits. There are certain feelings that people have changed their thoughts time to time, for example organ transplantation was not so widely accepted where as now it is clearly one of the established medical treatments. If the timing is not good there are some things that are rejected, while others are welcomed depending on the era.

Using cloning for people who otherwise will not be able to have a genetically related child was discussed in depth, because it may be an example of a case where cloning is not against human dignity. To this topic, some people argued that other assisted reproduction techniques are already unnatural, so there is not much difference in using cloning as another option. Also if there is some hesitance in having a child with no sperm and egg fertilization, to make them from Embryonic Stem (ES) cells and fertilize could be a way, now that ES cells are being rapidly researched. Another person was concerned that cloning acts to simplify or even monopolize the genetic sequence. Looking at the history of evolution, it is clear that life evolved by keeping its diversity, and if one type of genetic sequence is to dominate, ultimately life cannot protect itself from diseases and changes of environment.

Also some people argued that to use cloning technology would become more accepted in countries where birth rates are low, which makes people more sympathetic to people who can not have children, where as in countries with high birth rates (i.e. in developing countries that suffer from over population), it could be less accepted. It is also difficult for society to say no to people who "honestly" wish to have children. However, opinion surveys in India, which is highly populated, suggest people are actually more willing to use genetic technology than in Japan. Still there were some arguments that satisfying endless personal desire might not be the happiest way and that when something goes out of plan, people might want to blame it to somebody.

The Vatican has always made its position clear to newly introduced technologies, but this decision can change according to world trend. The effect of religion upon people's decision-making in Japan is not clear statistically, but in foreign countries there is a situation where law prohibits something because of religious reasons. For example in orthodox Islamic tradition, sperm donation is considered adultery therefore it is prohibited.

While this meeting's main topic was about cloning, many members were interested in its relation to organ transplantation, which we discussed as a separate topic in meetings 11 and 12, as will be discussed in section 5 of this paper.

Following this discussion in meeting 7, the first on cloning, for preparation and to enliven discussion, every member took back a different book on cloning to read. Also we encouraged people to bring questions, or questions that friends had, to make discussion more active. The books given that were introduced in meeting 8, the second on cloning, were as follows (all in Japanese): "Cloning technology", Cloning Technology Research Institute, (Japan Economics Newspaper),"The World of Clones", Mituaki Nakauchi (Iwanami Junior Shinsho 1999), "The Birth of Clones", Setsuo Iwasaki (Wani Books 1997), "CLONES and CLONES: Facts and Fantasies About Human Cloning", and Martha C. Nussbaum and Cass R. Sunstein (Sangyou Tosho 1999), "Is Cloning Devil's Science?", Masao Karube (Shoudensha 1999), "Real Clone", Michihiko Iwayama (Shougakukan 2000), "Remaking Eden", Lee. M. Silver (Shoueisha 1998)

In addition to the books, Ms. Ohtani introduced a movie film "GATTACA" which she had used as bioethics material in her high school classes. A high school biology teacher, Mr. Shirashi, introduced a comic book by Osamu Tezuka "Humans Come Together". These two works looks at the dilemmas related to cloning from its unique point of view. The movie "GATTACA" proceeds in an imaginary world where parents can literary "create" their children as they wish the child to become. This movie draws attention to a child who is born without human manipulation and to another child whose genetic sequence is changed to promise the best potential a human could have. The writer Osamu Tezuka often chooses cloning as the theme of his story. In this comic book, he creates a world in which cloned humans are sold as battle soldiers to various countries. The impression or the group was that these two works represent very well the vague uneasiness society feels towards cloning.

From these introductions, some people questioned scientists and their behavior towards research. Some considered that scientists tend to isolate themselves into their research as a result of exploring their honest curiosity, and the side effect of that could be that scientists are not able to look around the environment (society's reaction) to what they are doing. As one example, Prof. Iwasaki from Tokyo Agriculture University was mentioned. Also there was a mention that some high school biology teachers feel the same kind of love towards insects as to humans. The general attitude toward scientists was that the joy of fulfilling their research seems to be greater, than their asking whether the experiment or research was acceptable or not. On the other hand, people questioned how much people could trust ones common sense, not only in scientists but also in ordinary people as well. In the course of developing and diffusing technology into society, scientists' responsibility is needed, but maybe now the time has come where ordinary people have to take responsibility in their decision-making.

The most emphasized point was that we should not be regulating cloning technology itself, but the applications that use the technology for specific purposes. Cloning for medical use such as making human insulin in microorganisms or cloning for plant breeding is already accepted, but when the topic is to use cloning for reproduction (or making human clones), there seems to be much debate. First of all one person mentioned that in modern situation it is impossible to make a human clone secretly, and even if a human clone is made successfully it is not going to be cost effective, therefore the market would not accept it. On the other hand, we cannot forget that this might be the last hope for couples that would want children, and the potential to solve chronic lack of organs for transplantation, and that there is a group that plans to make human clones.

Another person argued that in present situation, there is over reaction to the potential of ES cells. There might be other experiments or research that could be done with less money and be more effective. To this point also people agreed that it is not all the research about ES cell that is bad, but we should look at the individual research cases.

This might be relevant to any new technology, but while questioning the acceptance of technology itself, we must not forget to investigate each case where the technology is used. Also, when a new technology is introduced to the society, the image might be altered by the basic knowledge that people have about that technology. False information or lack of information might be on big cause of people's instinctive fear towards something new that they don't know. One member pointed out that it is very difficult in the present Japanese situation to educate people with such basic knowledge. This is because the present science education (high school science etc.) focuses on developing systematic way of thinking science, and not dealing with issues that relate more to the actual living.

During the discussions, on 13 April 2000, the Japanese government considered a bill regulating the use of cloning technology on humans. In this bill, the making of human clone is considered to "have great effect on the maintaining of human dignity and social order" therefore the implantation of clone embryos back to the womb would be prohibited. Members felt the vagueness of the word "dignity" used in the bill. There were two opposing arguments to "dignity of life" which some person felt that it was a human dominated way of thinking and that only humans can feel dignity, and another that maybe animals also have dignity (or feeling that is similar to dignity) but humans can not know. Still in both opinions, people agreed that humans invented the word "dignity" therefore it is up to humans' judgment whether somebody (some thing) acts with dignity. As will be discussed below, in November 2000, a "Human Cloning Regulation Act" was enacted.

There are two ways to argue for dignity, one being intrinsic and another being extrinsic. Intrinsic dignity refers to the potential when any human is born to make an autonomous decision and extrinsic dignity is when somebody acts upon somebody else because they recognize the other's dignity. But the UNESCO Declaration on Human Genome and Human Rights, article 11 is against human cloning, not based on either of these two levels of dignity, but rather based on the two ideas: 1. Humans should be born by chance (by God) which suggests the consideration of dignity of the species than the dignity of individual and 2. Human diversity must be maintained as an intrinsic good. The UNESCO Declaration suggests that children should be born by chance. Is it bad for people to design their children? Sperm and egg donation are approved at present, but maybe in the near future, there might be donation of cloned embryos. To this possibility, most people felt it is malicious to make children for any kind of characteristics (cleverness, sports ability or good looks). Also everyone was against moneymaking in a cloned embryo market, and thought that children should be born as a crystal of their parents' love. Selecting life disturbs many people, maybe because it touches the taboo that people feel.

Therefore we developed the statement. The statement given in full in Appendix B has been approved by 21 members, both in English and Japanese. We will discuss the background to some articles following the text of the relevant statement article below.

4. Two recent techniques have made it possible to make clones of animals. One is embryo splitting, which involves the separation of cells from the same embryo to generate individual embryos, which can be accomplished only in the first 4-8 cells in mammals. The other is somatic cell nuclear transfer into an enucleated egg, which then grows as an embryo. Both these procedures require engineering that cannot be seen in nature.

This introduces both of the techniques used for cloning, embryo splitting and nuclear transfer. We discuss ES cell techniques in a little detail; since we found t his subject was of great interest to the group. This may have been due to the active media reporting at that time, earlier in the year 2000.

In section 'Regulations of cloning', articles 6 and 7, some examples of regulations taken by different countries and societies were discussed. We mention Article 11 of the Universal Declaration on the Human Genome and Human Rights, HUGO Ethics Committee "Statement on cloning", and the Council of Europe Convention on Biomedicine and Human Rights as examples of global regulations.

8. As mentioned above, vegetative propagation of plants has been used over a long time period and there are no objections to it. Commonly this includes cutting of trees and shrubs, splitting of bulbous plants, such as potatoes, sweet potatoes, tomatoes, asparagus, rice, strawberries and melons for food. Expensive flowers such as lilies, tulips, chrysanthemums and orchids are also commonly cloned in Japan. We accept the cloning of these plants.

We have decided to divide the use of cloning technology applied in different groups of organisms, because the initial reaction of the group members to make a statement was that the topic being too broad, it seemed impossible to include every aspect of the technology. For plants, everyone agreed it was already accepted.

12. Creation of cloned pigs as organ donors has also been reported. It relies on genetic engineering to make "humanized organs" fit for transplantation. Making organs for human transplantation in animals was the topic most discussed in the group. The concern here is whether it is ethical to make organs in animals, because it means they have to be killed when needed as an organ donor. Pigs are considered by many as the best animals, because their body size, internal gut system, and biochemistry are similar to humans and also from its long history of being raised for meat. People felt it was socially hard to accept the killing of organisms close to humans, such as the great apes.

This issue was the topic most discussed in the group, as also mentioned above. Is it ethical to kill animals to extract organs for transplantation? How is it different from killing for their meat? By using cloning technology, mass production of "humanized organs" becomes possible. The issue of creating a "human desired animal", and its killing, seemed to bother many members as something too egoistic by humans. Still, members could not deny the fact that if by creating "humanized organs" in animals, many people suffering severe diseases would be cured, hence there will be such a business. The issue of demand is also related to the desire to use assisted reproduction.

14. Reproductive cloning of human beings is against Article 11 of the Universal Declaration on the Human Genome and Human Rights that Japan has endorsed. If the cloning of human beings becomes technically safe, to use cloning as an assisted reproductive technology could be the solution for some infertile couples who do not wish to use donated sperm but want to have a genetically related child. On this issue we did not have consensus whether it would be ethical.

Some people have a very strong desire to have a genetically related child. Advanced technology enables, and supporters would say empowers, many couples (or single mothers and fathers), so they are able to bear a child, or at least try to do so.

17. If technology advances, it will be possible to obtain a clone of the individual at the time of their birth (a spare copy of a whole body). We consider this to be unethical to treat a person in this way as it violates the dignity of life.

Article 17 was added in response to some members' fears that in the future, cloned individuals would be discriminated against. We believe that all persons hold the same dignity, no matter how they were born. This statement was also circulated, as for the GMO labeling statement.

5. Other Topics

As explained above in section 2, there were two other topics discussed for two meetings each. Meetings 5 & 6 followed up the GM food meetings with discussion of Intellectual property and life, and farmers' rights in the age of biotechnology. It had been a subject briefly debated in the earlier meetings, so we thought it might be useful. To stimulate discussion, we asked a company patent lawyer to present a summary of the patent system. Patent rights protect inventions. This raises the issue of "What is invention?" An invention was summarized as highly technical ideology that uses laws of nature. Laws of nature empirically explain the natural phenomenon that happens around us. Therefore, computer programs, economic laws and psychological laws are not included as laws of nature. Even the experts have not been able to explain concretely what a highly technical ideology is, but it broadly indicates the actual process of problem solving, or concepts with a technical core. An invention is something novel, unpublished and created.

After an overall explanation of the patent system by the speaker with members' questions, we discussed the issue of genomic industry's patenting of multiple genes. There was a suggestion that this may be a preventive patent, which is in contrast to an active patent, hence application is done but few of them may be filed as actual patents. Secondly, as an example of benefit sharing, the case in India regarding the Neem tree was discussed. The argument was that researchers in developed countries collecting traditional medical plants from countries that does not have a patent system, should give some benefit in return of the extracting of effective substances. Still, if the country in which the tradition was kept, e.g. medical uses of Neem tree, and the same patent was applied, then the discovery is not new, therefore it cannot be patented. If they were used without knowing its medical effect, the extracted substance would have property rights, so as far as patent law is concerned, there is no problem. Hence the return of benefit would be fair. When country differs and the gap of economic power is great, international patent rights and its use must be further discussed. There were mixed opinions, and the two meetings allowed members to understand the laws on patents. All members thought we should protect indigenous traditions from exploitation by companies in rich countries, and while people supported patent system inside each country, they questioned the usefulness of it between rich and poor countries.

At meeting 11, we discussed the issue of organ transplantation. At this meeting, Mr. Ogawa who is a program director of the national television (NHK) gave some insight on the issue of organ donation from brain dead bodies, taking the Netherlands as an example based on his research there. The Netherlands has adopted a system 3 years ago, in which the Ministry of Health and Welfare controls whether an 18 year old citizen wishes to be a donor or not. There are 4 choices in the opinion sheet distributed by the Ministry of Health and Welfare: 1. The individual agrees to be a donor (In the Netherlands, a person can be a donor without a third person's consent unlike Japan); 2. The individual disagrees to be a donor; 3. The family chooses; 4. A third person chooses. But they made it optional to answer when in doubt. Consequently 40% of persons did not. Even if the individual agrees to be a donor their family might disagree, hence in many cases the opinion sheets stay unsent.

One person commented about the TV program, that the most moving scene was when a doctor ponders after the transplantation to the fact that it has one person's death as a prerequisite, which makes organ transplantation a very unusual treatment. According to one survey, to the question "Has your quality of life improved?" after the transplantation, 20% of the people answered "No". In the U.S. also, availability of a system did not necessarily mean that there was no problems. Like this, organ transplantation from brain dead bodies withholds various problems, since it is a medical practice in its developing stage, which became the main point of discussion.

As for organ transplantation, people thought that there might be more technology that would develop in the near future. Studies to create substances that suppress organ damage and xeno-transplantation were given as examples. Also, one member pointed out that the practitioners take this technology as a transitional medical practice, and that even though the system existed, medical personnel still have doubts about brain death as an actual story. Patients' rights hold some problems, too. Members gave the case where Canadian government underwent a liver transplant to a baby, over-riding the parents' refusal, and a case in England where a 15-year-old girl called an accusation case rejecting transplantation as examples.

The center of this discussion was, as Kunio Yanagida a Japanese nonfiction writer has written; "Second person death" could be the problem. In Japan, a patient needs the family's consent prior to organ transplantation. Mr. Shiraishi from our group has conducted surveys to high school students on brain death as a biology teacher. From the results of this, students tended to admit organ donation from their own body more than their family members' body. Members of the group seemed to consider "Second person death" and family members' death gravely, and also felt that getting consent prior to death while they are still healthy might cause some uneasy feelings.

There was a question raised by one member. Why do we need the family's consent in Japan? This is maybe because we are concerned about another person's death. In countries where it is not written in law, still people might ask their family, or may not carry out the operation if the family was not satisfied, and where the donor's will is unclear. The Japanese law maybe related to the philosophical question of whose death the death of a person is, i.e. is it "the death" of the person who dies, or is it "the death" for those who are left behind. Also, Japanese politicians were very sensitive to the opponents of the law, and made the law restrictive.

Compared to other countries, in Japan for the past three decades, why was brain death debated so much among various bioethical issues? Ever since the first heart transplant 30 years ago, there has been mistrust to medical practice, and a variety of reasons have been debated in academic literature. Members felt that there may be a characteristic of people not to be able to accept death as an actual thing. Some members felt that Japanese people might take death more gravely than other countries, but others pointed out the diversity of views is found in every country.

In brain death cases, from the point that a third person is in charge of determining death, members wondered whether it was better to decide ones' own time to die. This also led the discussion to the living will that is becoming more popular in the west. Also, problems arise when family members disagree with each other. Since there are technologies to keep one person physically alive, members felt it was important to make their will clear before hand.

Members felt there was hope in the recent brain death cases where people had discussed with their family members and accepted each other's opinions. Maybe through these conversations, people would respect individual's opinions more when they actually face brain death.

Finally, many young people tend to show their opinion on organ transplants, which suggests that young persons, who have not experienced death of close relatives, might take death as an abstract thing. Members feared that lack of reality to "second person death" might lead to even more abstract images, which might lead to nasty crimes, committed frequently these days by young persons. While the discussion was good, the low turnout of members suggested this topic was not as interesting as GM foods for our members.

Lessons

The group functioned reasonably well as a discussion forum. Over one and a half years in the group, members felt easier to speak. This point is quite important for a focus group to succeed in a culture like Japan, where it is normally difficult for people in socially lower positions to freely dialogue with those in socially higher positions. Balanced opinions from every member were heard through the meetings, but as new members joined, it took them a few times to really open up.

Discussion and exchange of ideas is crucial, not only when building a consensus, but even in daily life situations, since every individual has their unique thoughts and opinions. A community (or a country) consists of a variety of people, and the members covered a wide range of occupations and experience, but worked together to discuss and learn about the environmental, ethical and social issues associated with the use of biotechnology based on scientific knowledge and practical reality. Occupation seemed to influence how people thought, at least to some extent. Sometimes, one person thinks some things are so obvious while others cannot comprehend at all, just like when one person feels the sun is yellow where as other person thinks it is red or white.

The method we used for discussing the GM labeling and cloning issues was to create the statements. This was mainly by repetition of discussion in the actual meeting, and informing through e-mail circulation of the minutes to those who could not attend every meeting. The process of making a statement by e-mail and fax feedback was effective. In fact, every member seemed to agree in principle to the statements. The statement was developed after incorporating their suggestions. However, several members felt they could not sign the statements. Two NGO members disagreed with the statement on GM labeling. A member of the government group, associated with the scientific determination of GM content of food, and the labeling regulations, said he could not sign without official permission and review of the statement, but he has contributed to the development through drafts of the statement. One member did not sign because of his position in the media.

By preparing a statement, members had a chance to focus our groups' conclusions after the debate from the group. In this way, members can feel some satisfaction that some concrete reminder is left, and that it may be able to help contribute to the continued social debate on the topic. Both statements are available on the Eubios Ethics Institute web site < http://eubios.info/index> The statements were both produced before important Japanese laws and legislative guidelines on these subjects. Labeling requirements on GM food were enacted in April 2001, and the Human Cloning Regulation Act in November 2000.

Listening to some members' comments, it was clear that people from a variety of walks of life were concerned about the implication of new biotechnology into their daily life, and wished to be informed. The problem seemed to be that there was little access to such information, which may be due to the lack of advertisement from different groups of interest, i.e. the producer of the technology, producer of products, the government, and academic institutions. Also members pointed out that specialists are not always the best communicators, indicating that transfer of information must be comprehensive, depending much on the media and other mediators. How to present the information was another issue. Members felt that small group forums such as this were effective, because persons could express their concerns directly, and interactively, not only receiving information from lectures, news paper articles, or TV programs.

There is enough information about modern biotechnology that is waiting to be known, and enough people who can do so if they are given, and take, the opportunity. Some attempts to link public concern and specialists' knowledge by newspaper publishers, government institutions, and individual companies have been made in Japan. But these are large group lecture forms, and we suggest more small group forums with people from different groups can contribute much to the debate process that will lead to policy formation. This experience is applicable to many societies, and has been shown to succeed in a society where traditionally there is a gap between experts and public.

7. Appendix

A: Statement on GMO Labeling Policy in Japan

We are a group of ordinary citizens who meet together to discuss life and biotechnology. We speak as individuals and not as representatives of our employers or our specialties. We cover a wide range of occupations and experience, but we work together to discuss and learn about the environmental, ethical and social issues associated with the use of biotechnology based on scientific knowledge and practical reality. We wish to share what we have learnt from each other during our study of the issues associated with genetically modified foods.

1. We emphasize the need for an open and transparent process of the introduction of novel foods and products to our daily diet. This responsibility is shared by scientists making the new varieties, seed companies and suppliers, farmers, transporters and agents, food processors, and retailers.

2. There has been extensive research on the environmental and human health issues raised by GMOs and genetically modified foods since the 1980s. Until now there has been no concrete case of human health suffering from consumption of genetically modified foods themselves. However, research should continue on commercial scale releases.

3. There has been much conflicting information on the issues raised, and the responsibility for this rests with the persons speaking in the media and the media selection of information. The media should be the bridge between researchers and people. The media should carefully consider whether the information provided is accurate, and if it really helps consumers make informed decisions.

4. There should be long term monitoring of the use of GMO crops for environmental concerns, and this can be accomplished with cooperation between seed companies and farmers.

5. It will be very difficult to monitor long-term health effects of genetically modified foods because every person already eats so many different foods, many of them are known to have health risks exceeding any potential risks posed by foods which contain components made from genetically modified organisms. For example, many everyday traditional products such as grilled fish and meat, beverages, sauces, contain known carcinogens, but these products are not tested. However, decisions should be made on a case by case basis considering international practices and recommendations of Codex Alimentarius.

6. There is a need for careful assessment of new potential allergens in food, which is a reason for including labels on food that has any such component at allergic level. Food safety derives from the ethical principle of do no harm.

7. We welcome the decision of MAFF that proposes to introduce a guidelines and policy on the sale of food made from GMOs and through recombinant DNA technology, as a starting point to promote more transparent systems. We wish to make some comments specifically relating to these guidelines.

8. We consumers should have access to all products in our community even though individual supermarkets may stop selling certain products, to exercise market choice. Ideally supermarkets should display the products side-by-side to allow free choice of consumers.

9. The special handling of different seeds has a precedent in organic agriculture, and in different varieties. However like all special handling, it will increase costs. The costs of the product should be met by the consumers who chose that product.

10. Those persons who want to have identity preserved (IP) foodstuffs should pay the extra costs of that process, and it should not be passed on to all consumers. However, the system of safety checks should be supported by the food industry, and the government.

11. The verification of not genetically modified segregated label is the most difficult to proof, and there should be penalties for false labeling of food as "GMO free." We want the penalty system to be clarified, for example will violations be imposed under the JAS penal regulations or another system? The difference between strict and bulk identity preserved IP handling, that is used to define the proposed exemption levels should be clarified. How will the consumer know? The proposed exemption levels should be developed consistent with international standards.

12. Peoples perception of risks vary with the individual and are often not scientific, however, it is a fundamental human right to avoid significant risks. One way to compare significant risks is to compare to existing foodstuffs that a person consumes. The guidelines make an attempt at reasonable discretion between foods that require labels and those which do not, but all foods included or excluded should be done so on the basis of scientific rationale from volume of food and components included. The long-term effect of consuming GM food and vectors should be monitored, and allergy testing should be ensured.

13. It is not always true that there is more comfort with more knowledge, but we live in an informed society and people should have access to extra information if they wish it. A practical system should be introduced and we propose that one reliable and standard information site on each product should be made on the Internet by an independent advisory group, possibly to the MAFF/MHW in cooperation with companies and consumers. This would lessen the conflicts between different data so that people could trust someone. Both positive and negative information should be presented.

14. Japan is dependent upon imported goods, and a variety of health claims are made about domestic and foreign products. Any information should be carefully provided, not only for GM food. The government should be more proactive as the representative of the concerns of all persons in society not only the major industry or loud voices of protest. There could be lessons from the creation of the independent food council in the UK.

15. There should be a system established for prevention of risks in the event of any accidents, or unforeseen events, with clear responsibilities assigned. This type of incident may occur in growing the crops, so seeds and seedlings should be labeled clearly for farmers, and monitoring should be coordinated between production and consumption systems.

16. All persons who are informed about these issues have a responsibility to share this information with others. While there should be more education of the issues in schools, we cannot leave spreading of information to formal education. People discuss these topics among their family, circle of friends and colleagues, and in society, and all citizens have responsibility. Some consumers can be easily influenced by news, although a majority is not so interested, but information should still be accessible to allow proper understanding. Between consumers and producers there should be a monitoring system developed, to ensure quality of information.

In conclusion we would argue that any new technology should be subject to reasonable benefit/risk assessment, and new options be presented to farmers and consumers.

Signed by the following members of the Life and Bio Thinking Group November 1999
Takashi Etou, Importer
Kazumi Inagaki, Freelance translator
Akihiro Oates, Journalist
Yuri Oiwa, Political Journalist
Izumi Ohtani, High School Ethics Teacher
Makina Kato, Student, University of Tsukuba
Fumiyo Kitahara, Company worker
Naoki Shiraishi, High School Biology Teacher
Mariko Takahashi, Science Journalist
Yu Tatesawa, Company Worker
Hitomi Tsusaka, Company worker
Satoko Hayashi, Student, University of Tsukuba
Fumi Maekawa, Eubios Ethics Institute
Darryl Macer, Eubios Ethics Institute

B: Life and Bio meeting statement on cloning

A: Foreword

1. We are a group of ordinary citizens that meet regularly to discuss issues related to biotechnology and life. The group consists of people from various positions and we cover a wide range of occupations and experience, but we aim to discuss and learn about the environmental, ethical and social issues associated with the use of biotechnology based on our personal experience, scientific knowledge and practical reality. We have discussed cloning in this way over 4 meetings and would like to present this statement as a group consensus. This is a summary of our positions on the following topics raised by the availability of cloning technology.

2. The biological definition of a clone that already exists in nature could be as the following; groups of cells or organisms that are derived asexually from an organism; a tissue or a cell that carries identical genetic information. This activity is commonly seen in organisms such as bacteria and other unicellular species. Identical twins or triplets are clones of each other, which is an example we can see in our life already.

3. Humans have used cloning in plants over a long time period. Taking cuttings of trees has been commonly used for plant breeding, and some vegetables are commonly cloned.

This process needs human hand, but it is very similar to cloning seen in nature.

4. Two recent techniques have made it possible to make clones of animals. One is embryo splitting, which involves the separation of cells from the same embryo to generate individual embryos, which can be accomplished only in the first 4-8 cells in mammals. The other is somatic cell nuclear transfer into an enucleated egg, which then grows as an embryo. Both these procedures require engineering that can not be seen in nature.

5. The development of human embryonic stem (ES) cell lines, derived from a somatic cell, that are capable of embryonic development, creates new opportunities for cloning and genetic engineering. The nucleus of a genetically modified ES cell can be implanted into an enucleated fertilized egg. This also requires engineering done by human hand.

B: Regulations of cloning

6. Following the birth of Dolly, the first mammal to be cloned by adult somatic cell nuclear transfer, in 1997, there were a number of international statements against human reproductive cloning. Article 11 of the Universal Declaration on the Human Genome and Human Rights reads "Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted." This was approved by all member countries of UNESCO in 1997 and all United Nations member countries in 1998. The Council of Europe Convention on Biomedicine and Human Rights outlaws reproductive cloning of human beings. The HUGO Ethics Committee "Statement on cloning", is against use of somatic cell nuclear transfer into enucleated cells.

7. Some countries have prohibited human reproductive cloning, including New Zealand, and Israel. In Japan the Subcommittee on Cloning of the Committee on Bioethics of the Science Council of the Science and Technology Agency recommended a law be made to ban human reproductive cloning in November 1999. A bill was presented to the Diet in Japan, on 13 April 2000. The main goal of this bill was to prohibit human cloning by banning experiments that plan to implant cloned embryos, hybrid embryos and chimera embryos. It would have a five year period of duration, like the law in Israel.

C: Cloning of plants

8. As mentioned above, vegetative propagation of plants has been used over a long time period and there are no objections to it. Commonly this includes cutting of trees and shrubs, splitting of bulbous plants, such as potatoes, sweet potatoes, tomatoes, asparagus, rice, strawberries and melons for food. Expensive flowers such as lilies, tulips, chrysanthemums and orchids are also commonly cloned in Japan. We accept the cloning of these plants.

D: Cloning of Animals

9. We will deal with specific uses of animal cloning as below, noting that it should be subject to the same principles concerning animal welfare as other experimentation on animals or livestock husbandry. Its purpose should be clearly defined and procedures should be subject to ethical review.

10. One purpose is to alter the inherent property of the animal to obtain better meat, wool or growth rate, for example. This has been performed in Japan in the pursuit of "marbled beef". By using cloning technology, the expected offspring will have the same genetic information to the clone donor. Before being widely used we should be sure the properties of the animal are stable, and the animal is not suffering. One objection to use of cloning or genetic engineering for mass livestock production may be the decrease in genetic variety. We note that over the twentieth century biodiversity of plants and animals used in food production has decreased. It is not hard to imagine artificial elimination of many genetic traits that may appear unappealing to human eyes.

11. Another reason to clone an animal is to create an animal bioreactor, to produce valuable substances through the use of genetic engineering. Cloning only makes a genetic copy of the cell with the engineered genetic sequence. One example are sheep that produce milk that contains medically useful proteins.

12. Creation of cloned pigs as organ donors has also been reported. It relies on genetic engineering to make "humanized organs" fit for transplantation. Making organs for human transplantation in animals was the topic most discussed in the group. The concern here is whether it is ethical to make organs in animals, because it means they have to be killed when needed as an organ donor. Pigs are considered by many as the best animals, because their body size, internal gut system, and biochemistry are similar to humans and also from its long history of being raised for meat. People felt it was socially hard to accept the killing of organisms close to humans, such as the great apes.

13. Another reason for cloning is in conservation of biodiversity. It can be used to help increase the numbers of members of endangered species. The potential availability of cloning as an emergency procedure to save the last few members of a species, lack the consideration of individual genetic variation thus should not lessen the drive to protect the habitats where endangered species live.

E: Cloning of Humans

14. Reproductive cloning of human beings is against Article 11 of the Universal Declaration on the Human Genome and Human Rights that Japan has endorsed. If the cloning of human beings becomes technically safe, to use cloning as an assisted reproductive technology could be the solution for some infertile couples who do not wish to use donated sperm but want to have a genetically related child. On this issue we did not have consensus whether it would be ethical.

15. As mentioned above, making organs for transplantation could be possible in vitro in the near future. This idea might be a big step forward to people who suffer severe diseases, and already skin grafts have been reported possible. The issue should be subject to informed consent of the person receiving the transplant, and the consent of the donor in the case it is different to the recipient.

16. There are ethical issues raised by the collection of cells and materials that may be used for ES cell research, and tissue generation. These should follow international standards, and be clear on the use of the tissue, intellectual property rights, and disposal of excess, before collecting the samples.

17. If technology advances, it will be possible to obtain a clone of the individual at the time of their birth (a spare copy of a whole body). We consider this to be unethical to treat a person in this way as it violates the dignity of life.

F: Implications for Respect of Life

18.We think society needs to discuss questions like "How and from where do we call one person a "human"?", "Is it still the same person even if the whole body has been exchanged to a healthy new copy?" Genetically it would be the same person since it is a clone of the original person. Though there are some minor genetic changes that alter the expression of genes between different individuals as well as the difference in the cytoplasmic genome sequence, even though the nuclear genome sequence is the same.

19. There are fundamental ethical principles involved in human activity, which touches and helps create human life. These principles include autonomy, justice, do no harm and beneficence. Human dignity is a difficult concept, but includes intrinsic value that every person has, and extrinsic value society places on others. Human diversity is valued, as part of this dignity. Cloning if used for "pre-destination" of a child into a tight mould is against human dignity.

G. Openness and scientific responsibility

20. We emphasize the need for an open and transparent process of the development of science. This responsibility is shared by scientists doing the research at all levels, and those who develop and nurture the organisms grown.

21. While there should be more education of the issues in schools, we cannot leave spreading of information to formal education. People discuss these topics among their family, circle of friends and colleagues, and in society, and all citizens have responsibility.

22. Society has a responsibility to develop new medicines for the sick, and to make agriculture more environmentally friendly and involve less suffering to animals, but this process should not be against ethical principles.

Signed by the following members of the Life and Bio Thinking Group July 2000
Takashi Etou, Importer
Renko Isowa, Producer
Kazumi Inagaki, Freelance translator
Akihiro Oates, Journalist
Yuri Oiwa, Political Journalist
Izumi Ohtani, High School Ethics Teacher
Yoshihiro Okada, Company worker
Masae Ono, Pediatrician
Makina Kato, Student, University of Tsukuba
Takako Kaneyasu, Marketing Manager
Fumiyo Kitahara, Company worker
Hiroaki Koizumi, High School History Teacher
Naoki Shiraishi, High School Biology Teacher
Yu Tatesawa, Company Worker
Mikiko Chikaoka, Student, University of Tsukuba
Hitomi Tsusaka, Company worker
Satoko Hayashi, Student, University of Tsukuba
Kunio Watanabe, Company worker
Fumi Maekawa, Eubios Ethics Institute
Darryl Macer, Eubios Ethics Institute


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