Discussion and closingpp. 149-155 in Bioethics and the Impact of Human Genome Research in the 21st Century

Author:

Editors: Norio Fujiki, Masakatu Sudo, and Darryl R. J. Macer
Eubios Ethics Institute

Copyright 2001, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.
8.3. Lessons from the Fukui Seminar

Norio Fujiki (President, IBSF)

 As described in UNESCO IBC Newsletter (1995) by Professor Jean Bernard, honorable president of IBC UNESCO, the next themes of IBC may include Money and Ethics, discussing the gaps between the great economy of pharmaceutical businesses in developed countries, or the organ transplantation businesses in the developing countries among North- South and West and East. Also there will be discussion on differences in disease patterns, life expectancy, nutrition, infections and environments, among the developments of sciences and technologies.

Although we have basically made genetic data open to the public, Celera Genomics has limited the use of the data from what they claim to be 90% of the genome. They also prepared the applications for patenting. However, U.S. President Clinton and British Prime Minister Blair have called for the genetic information to be open. They also have supported databases for genetic mutations. Such human genome is regarded as common heritages of humankind, to be equally utilized without any difference of countries and communities, as stated by the Universal Declaration of Human Genome and Rights.

We have clarified the judicial use of intellectual property rights for promoting research developments by commercial organizations on genetic information. We have developed the new technologies using DNA Chips and SNP technologies for the suitable drug discovery, tailor made gene diagnosis and therapy. Therefore, we planned to have 6 plenary and 18 complementary lectures with public debates, as well as 4 public lectures in the evening seminar before the main program. We discussed the followup studies on the guidelines on medical genetic services, following up on the 1997 UNESCO Asian Bioethics Conference and its Satellite Symposium on Medical Genetic Services, by revising the draft guidelines, led by Dr. Bulyzhenkov. Professors Matsuda and Wertz chaired the panel discussion by 10 panelists from 7 different counties on the different trends and impacts on different topics of genetic testing, prenatal diagnosis and gene therapy, as well as genetic counseling such as informed consent, privacy and autonomous decision-making, genetic susceptibility, genetic discrimination in insurance and employment, as well as human rights of patients and family members, and if necessary, to strengthen suitable care and supports. Lastly, medical genetic services in the USA and Japan were compared, looking at how social agreements are made.

At the end of seminar in this session, we have discussed the future of Bioethics, Health and the Environment, including discussions at the three conferences, in Tsukuba, Tokyo and Fukui. After this week with 100 invited speakers, and participants including 60 members of Fukui Life Academy, we wish to acknowledge the support by Monbusho, Japan Expo 70 Fund, Osaka Tokyo P.M.A., SmithKline Beecham, Toyobo, as well as Fukui Prefectural Government, Fukui International Association, Fukui Convention Bureau and Fukui Medical School. We also thank all the participants around the world, and acknowledge the tremendous efforts of three simultaneous interpreters, Dr. Richard Clark, Mrs. Kazumi Inagaki and Ms. Fumi Maekawa, and publisher and member of organizing committee, Professor Macer of the Eubios Ethics Institute. Also all the secretariat staff, all doctors and secretaries in the Department of Internal Medicine, Fukui Medical University, particularly Professor Kuriyama, Dr. Hirayama, Secretaries, Mrs. Nakagawa and Mrs. Hayashi, as well as Mr. Yamamoto of Studio Nippo.

8.4. Closing Address

 Keichi Ueda (Director, University Hospital, Fukui Medical University)

 At the end of this Seventh International Bioethics Seminar in Fukui, it is my pleasure on behalf of the seminar and MURS Japan, to give the closing summation.

On the first evening Professor Okamoto, President of MURS Japan, Reverend Kimura of Eiheiji Temple, Dr. Fujita, head of the Kyoto Pasteur Research Institute, and Dr. Yamori of Kyoto University, each presented public lectures. On the second day plenary lectures were given by Drs. Byk, Kneller and Kobara, followed by it explanatory lectures on genomic drug discovery, and the technology and application of DNA polymorphisms.

On this the third day we have heard during the morning panel discussion, presentations of present developments concerning guidelines on medical genetic services from the United States, United Kingdom, France, Germany, India, Japan, and other countries. Finally we heard plenary lectures from Dr. Takaku, President of Jichi Medical School on the introduction of advanced medicine, from Dr. Williams on genetics and bioethics, and from Professor Shimizu on the human genome project and the impact on genetic science. All of this led to a wide dissemination of knowledge, ideas and opinions.

This Fukui seminar followed conferences in Tsukuba and this series showed us the importance of bioethics education in medicine also. I hope that this seminar sends an important message to the whole world.

Finally I would like to thank the invited speakers, participants, and organizers for this most successful conference as we bring it to a close.

Closing Discussion

 Macer: I am going to immediately start the closing session, which will include papers by myself, then Judge Christian Byk, then general discussion and final remarks by Prof. Fujiki and Ueda. Are there any questions on my paper?

Azariah: Currently there is no well-defined protocol and guidelines on introducing new gene sequence in plants and other animals, and releasing them into the environment. I think there is a need to develop regional and global consensus on this issue. Secondly, the responses of people on risks and benefits of this newly modified organisms have to be understood in a pluralistic way in India. We have done only a small survey, but in India, 25 different states have 25 different foods and 25 different dresses and cultures, so we need to develop basically unified consensus of all these different regions to arrive at a protocol for developing a safe approaches and guidelines.

Macer: There is a history of 15 years of introduction of genetically modified organisms to the environment in controlled field trials in a number of countries. There is also a history of commercial release of these crops for about 5 years in the US, and China, and somewhat less time in Europe. In some countries there are guidelines that do adequately assess the risks that GMOs pose to the environment. The question is how these can be extended to all countries, and to all local areas within countries, when farmers may be approached individually by companies or seed suppliers, and when it may be beyond the control of any regulatory authority. So there is a gap there in some countries. I think there are efforts to try and harmonize these guidelines, and one effort in the inter-boundary movement is the Cartegena Protocol attached to the Convention on Biological Diversity, which regulates inter-boundary movement of live genetically modified organisms, which include seeds. There are other efforts to try to develop other regulations but that is the most significant one I think. For your second question, what I've found in the surveys, and also the International Bioethics Survey conducted with yourself in India in 1993, is that people give a range of benefit and risks. This diversity is the same in each culture, and over the decade there has been a drop in the public support for release of GMOs of approximately 15-20% in every country in the world that has been surveyed. Especially in the last 5 years support has dropped about 20% shifting from the positive to negative. But still majority in most countries is supporting some specific uses. Most of this is due to polarization, people have been able to decide whether they support or don't support. Ten years ago there were more "don't know" answers.

Takaku: In regard to genetically modified food or organisms, I think the situation is different in each country. If many people have a deficiency of vitamin A, those people need genetically modified food which contains a very large amount of vitamin A. The same thing can be said concerning folic acid, so it is very difficult to make a world wide regulation concerning GMOs.

Macer: Yes, different countries have different needs. One thing that is interesting is that in Europe there is too much food, so Europeans if they don't want to export the food to the starving, then they don't need to use the new technology so much. But in Japan we don't have enough food ourselves, so we have to import. It's a little bit surprising we also reject some of this technology more, because really we should need this food to be more self-sufficient.

Manoj: I have wanted to address this particular situation for the past year but I have not had the opportunity to do so. Each person or commission I have observed is trying to explain bioethics in different ways. If I may be so direct, they are all trying to answer the question why did the chicken cross the road? In a way we are still juggling with older and newer ethical problems of genetics, medical practices, and also cybergation and co-modification of life. I request every single bioethics expert to devise and rationalize a universal or global code of ethics, which will offer no excuse for the willful manipulation of life and life related issues. A common phrase we could apply is "speak up now or hold your silence forever". Because we have to do something right now, otherwise we would just keep quiet, and keep arguing, and the problems will keep evolving and we won't have answers to them. So we have to put our foot down and devise a universal code of ethics now or never.

Macer: I think that would be an interesting question to debate, because I think I have discussed pros and cons, and what type of universalism I am talking of. Actually I think we already have a universal code we just don't know that it is bioethics code. This is controversial, as is the implementation of the Universal Declaration of Human Rights in some countries.

Matsuda: My understanding is that there is some difference between bioethics and ethics. Bioethics means ethical, legal and social issues. So every country has different law, social problems, and social background. I cannot say exactly, but probably each country will confirm some part, but in detail there are some differences between countries. We need to have this discussion in one kind of room, otherwise we cannot get to a final conclusion.

Macer: I think that every person has a different bioethic. I say it is bioethics if it touches life. We should not use cultural boundaries of the traditional sort, like skin color, or profession, to limit and say, for example, that scientists think like this, or philosophers think like this, or Africans think like this. This is not sociologically true of people, I think. I think diversity is great in every place.

Matsuda: That is why we see Beauchamp and Childress developed the four most important principles. These are the most important principles. We will have different problems in different countries, if we cannot put them together.

Macer: We should move to the next closing lecture from Judge Byk, who is Secretary-General of the International Association of Law, Ethics and Science which is the cosponsor of the meetings we have been having. There is now time for general discussion.

Byk: I would like to add a comment on my talk. It is not my own view but a synthesis of what I think comes from the Tokyo meeting.

Williams: I have more of a comment than a question. It relates to the comment made at the end of my talk by Dorothy Wertz about how we get people to act, get them to recognize our interdependence and the need for a sustainable future. At least in the US, we are making progress and we already have with issues related to bioethics. What is now known as the common rule now governs the elements of informed consent, and informed consent is now necessary for research. Unfortunately at a lot of times, at least in the US, a crisis needs to proceed action, especially legislative action. But I am hopeful that with continued conversation, and with continued efforts bringing crises it might be necessary for dialogue to get action. Bringing potential crises into people's consciousness, then we actually will be able to move in a direction that incorporates the kinds of things that we are talking about. Also we can help by making simple sets of questions or standards or principles, to share. Maybe a question we should recommend for a research might be "how does this affect the sustainability of the biosphere in the next hundred years".

Byk: I think the message of the Tokyo meeting, was that it is highly difficult to allow a mastership on technology and science today; it would probably be impossible to do it. But in the mean time, which is left to us before the system will go to its own end, because it has become such a complexity that it is impossible to maintain control over the system. I think the only thing we have to do is to base any of our action and activity on the reflection of our own anthropology, because we cannot use the existing disciplines they are not appropriate without referring to more fundamental references that are also to be reformulated or reconstructed.

Rajalakshmi: In my observation, both sustainable technology and a global ethical code may not emerge as such. Because technology is progressing much more rapidly. Before we are able to reach sustainable technology, the technology itself is likely to develop and go beyond certain levels. By existing diversity of cultures and ethics within groups, I think a global ethical code is also not likely to emerge.

Macer: Does anyone else have observations, and can I invite anyone to also share your own conclusions with us.

Takebe: We have been discussing about international bioethics, but I wish to point out that unfortunately in Japan, bioethics, at least in the medical community, is still far behind. Especially in genetics, we have 80 medical schools but only three has a formal human genetics department. There are about 10 so-called affiliated institutes but teaching of genetics to Japanese doctors is far behind. But still, we have to face the recent advancement of gene technology, gene therapy and genome analysis, this is a dilemma. What we need is a very solid guideline with understanding of background, not only in Japan, but it may be the same for all Asian countries including China, which has 1.2 billion people. As I said, we have had some discussion of ethical issues related to China's prenatal diagnosis, but we have found out that medical genetics in China is far behind compared to Japan. That is almost nothing I should say. This is an international meeting and we as participants from Japan, may think that we have mutual understanding. But I wish to point out from this discussion which we have to apply to Japanese medical education or medical practice, that we need a lots of effort to catch up with the recent advancement of gene analysis or gene therapy, so-called modern medicine.

Byk: In the coming years we will have assisted the development of professional ethics standards in different sub-fields concerned. The trend will be that at the international level, we will focus more on the international professional standards in diverse areas, than on the globalization of issues. I think such globalization will come to an end because different cultural approaches do not permit to go very much further.

Macer: I also agree with Professor Takebe that the shortage of genetics departments in Japan is very surprising, for a country which actually talked about the genome project before the US.

Takaku: As Professor Takebe mentioned, there are only a few genetics department in our country. I'm not speaking for the Japanese Ministry of Education, but I think many Japanese doctors and medical students are interested in genes or genetic diagnosis or gene therapy. So although we don't have many genetics departments, we are educating medical students on those issues very eagerly. I don't think the education of genetics and genetic medicine in our country is far behind from other developed countries. I am defending ourselves.

Vogel: I wish to comment that we are impressed by the contribution of Japanese scientists to science of human genetics. However, I was really surprised to hear that you don't have enough genetic counseling units. We have heard in application of all the new knowledge, genetic counseling is a very decisive element and that as a rule of thumb, that a population of between one and two million people needs one genetic counseling unit, for example in Germany or the UK. This is about the order of magnitude, a genetic counseling unit with about five full time scientists or medical doctors, and the additional staff of technicians, social workers, etc. This means in Japan it would be about 60-100 genetic counseling units for the entire country. Wouldn't it be possible to convince the Ministry of Health or Ministry of Education to found these units? If the medical insurance system of the country will pay for this in the normal way, then financing of such a unit will not be an insurmountable problem. Of course, I am a foreigner and I cannot say what you have to do. But when you look from a viewpoint of a foreigner, these things might be not only necessary but also feasible.

Byk: Just before you answer that question, may we put the question the other way around. Why is genetic counseling in a country where there is no social request for it? Why would it be necessary to impose it, I would say rationally, by a bureaucratic decision if the social culture of the country is opposing to it. There is no need. This is provocative.

Macer: In reply to your question Christian, in multiple opinion surveys of the Japanese public since 1991 find over 60% of respondents say they think genetic counseling services should be provided by government funding.

Byk: I can tell you a story about surveys. When I was in 1986 on behalf of the French government, Sweden had developed some understanding of why in Sweden they did not accept anonymous donors for donation. As for the survey, they explained to me they set up a national commission and there were 400 organizations. I asked what was the majority conclusion. They were for the reproductive services and for anonymity of the donors to facilitate the donation. I said why did you decide exactly the contrary. They said it was the government policy.

Macer: In this case the survey was of ordinary people and was against government policy, and the reasons were asked. Many considered it a right to health care, and also a right for the mother to chose. Some also considered the seriousness of diseases. It is quite an interesting phenomenon.

Matsuda: In the future, medical education should include not only the scientific viewpoint but also genetic services. Half of the lecture should be the medical science and the scientific view of genetics, but the other half should be about genetic services. It is very important for the genetic care. Generally, the genetics diseases have no cure. So the most important thing is how to care for the people with genetic disease. Therefore, we should have some kind of lecture about genetic services.

Shinagawa: One more important reason why genetic problems have not progressed in Japan in my opinion is that the Japanese health insurance system, which is covered by Japanese government financially, is not health insurance, but disease insurance. When a patient needs treatment then it is covered by health insurance. Therefore it is not health insurance but sickness insurance.

Takaku: What Prof. Shinagawa says is correct. Our health insurance system covers every Japanese, so we don't have to pay much money even if we get diseases. But the Japanese health insurance system is for treatment. Therefore if you do any treatment or use any drugs, insurance covers that. But this insurance does not cover any costs for prevention or counseling. Because our insurance system is going to be in a deficit, so our government is very careful if you pay money for prevention or counseling that the total cost will increase, and the government may not be able to pay for that. The government doesn't allow to mix the health insurance and private money, so the hospital cannot get money directly from patients. That is the main reason why counseling is not covered by health insurance in Japan. But we have to change of course.

Verma: In India, we face a similar situation. The problem of genetics being accepted as a medical discipline, and getting attention from the government, is because there is lack of therapies. There is a problem from the government, and the doctors also, that they feel that if they become geneticist and only do genetics, they may not make enough money because not many patients would come to them. Something of that may be applicable to Japan. I know that in the US also that some genetic counseling is not covered by insurance. When I was training in the US in 1971 and 1972, the genetic counseling we provided to the patient was not paid for by the insurance. So the geneticists had to fight quite hard at the insurance level, the medical level, the association level, to get this specialty recognized and paid for. So that whatever you provided in the genetic service was paid for. So I think this is not only a problem in one country.

Leavitt: In this point about medical insurance or health insurance that Professor Shinagawa started the discussion, I don't think it's a bad thing if a medical insurance system does not cover prevention. Because I don't think that prevention of a disease, that is to stay healthy, is necessarily the province of medicine. I think that people all over the world find ways to stay healthy and stay away from doctors without needing medicine - eating nutritious food, physical activity, yoga, martial arts, good breathing, meditation, organic food, etc. Everywhere you se shops for organic food, there are people who are opting out of the biotechnological agricultural system that we have been discussing. Through out this conference we have been ignoring a very large segment of the world that is not interested in our biotechnology. They are not interested in our high-tech medicine. They are finding new ways of life, perhaps traditional ways like Ayurvedic, which is very big now in Israel, alternatives to the system that this conference has been relating to. I hope that in the future, bioethicists will open their eyes a little more to alternatives and other views of life to the types of system that we have been discussing.

Byk: I think we make a mistake. Genetic counseling is not prevention but prediction. Those two are quite different. Also I think it is not correct to say that prevention should be distinguished from the practice of medicine, or at least from the public health policy, because the cost of certain disease should be lower with a good prevention of the disease in question. I think we are talking about two mistakes. Genetic counseling is not prevention, and prevention should be a part of the public health policy much more than it is in many industrialized countries.

Macer: I would like to ask Ivan Segota who is the chair of the Croatian Bioethics Association, please explain to us about genetic counseling in your hospital in Croatia.

Segota: I don't think I can talk about this, because I don't know too much about this problem. I know that we are trying to develop bioethics and discuss these problems. But we are, I would say, in the first steps. We are not developed as Japan or Europe or the US.

Macer: Would anyone like to make another comment. Is genetic counseling prediction or prevention?

Matsuda: In some cases, we can prevent, for example diabetes or smoking etc. You cannot just only say genetic counseling is prediction, because we are aiming to prevent the disease itself. We are also seeking knowledge about the disease that may lead to prevention in the future.

Byk: It is a double-faced technique, which implies that the consideration we have regarding to this technique. It should have some specificity.

Macer: Thank you all for your comments and discussion. We now would like to have the concluding comments to the Chair of this meeting, Prof. Fujiki, to whom we are very grateful for conducting this meeting. At the end we ask Prof. Ueda to close the meeting.

Please send comments to Email < asianbioethics@yahoo.co.nz >.

To contents page
To Eubios book list
To Eubios Ethics Institute home page