International Aspects: National Profiles, Japan


pp. 722-31 in T.J. Murray & M.J. Mehlman, eds., Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology (John Wiley & Sons, 2000).
Author: Darryl R. J. Macer
Outline

1. Genetic Engineering and Biotechnology in Japan

2. Public acceptance of biotechnology

3. Japanese law and biotechnology

4. Japanese culture, biotechnology and bioethics

5. The future and trust

Introduction

Japan spends more of its gross domestic product on research than any other country, and biotechnology spending is a high priority. The public in Japan is well educated, and is aware of biotechnology, perceiving both benefits and risks of most applications, and has a reasonable degree of bioethical maturity. Most of the regulation of modern biotechnology is through guidelines and directives issued from numerous government ministries. Among the many ethical issues that have been discussed, trust in authorities is one of the central public policy issues that must be dealt with in the future policy towards biotechnology in Japan.

1. Genetic Engineering and Biotechnology in Japan

Japan is one of the world leaders in modern biotechnology, producing over half of the world's antibiotics, building on a long history of fermentation technology. I define biotechnology as the use of living organisms to produce goods or services, which has a history as long as humans shaped the environment (1). While some may consider biotechnology to be a term more suited to genetic engineering and cell manipulation, to consider its ancient origins is important when we look at the ethical issues it raises and the legal approaches which have evolved. This may be especially true when we look at the origins of the concepts of bioethics in Asia, because the links to the past may be more emphasised than in the context of Europe or North America, where terms like "genethics" have arisen (2).

There have been several surveys of the progress of Japanese biotechnology research, and the policy decisions behind that (3-5). The government and industry has been promoting biotechnology throughout the 1980s, and it has been predicted that by the year 2000, bioindustry will represent 10% financially of the Japanese economy (6), with 90% of this in traditional industries such as fermentation of food and drink. There has been some government and industry efforts to promote biotechnology, including the Bioindustry Development Centre (BIDEC), now called the Japan Bioindustry Association (JBA), a private think-tank of the Ministry of International Trade and Industry (MITI). The Science and Technology Agency (STA) also has invested in public acceptance of biotechnology. The prefix "bio" has been applied to many new words in common Japanese language, like biocandy or biocosmetics, maybe more so than in the language of the public in most other countries (7).

There is a very positive view of the contribution of science to improving the quality of life and economy. Research spending in Japan, at 3% of the Gross Domestic Product (GDP), is the highest level in the world, with US$120 billion being spent in the 1996 fiscal year (8). The USA spends about 2.5% of GDP, though 0.5% is due to defense industry. About 15% of this funding is from the government, being similar to the USA (16%), but less than in the UK (23%) and France (37%) (9). Between 1996 and 2001 the government has promised to increase spending on research by 50%.

Agricultural applications were slow to develop, with few field releases of genetically-modified organisms (GMOs) in Japan. Although, the Ministry of Health and Welfare released guidelines to assess applications for foods and food additives made from GMOs in 1992 (10), at present most of the foods accepted by the regulatory committee are from foreign imports. Despite the efforts to promote biotechnology, there appear to have been some bottlenecks caused by strict or bureaucratic regulations. Up to 1994 there had been 13 GMO field trials compared with over 1,000 in the USA by that time (11). However, Japan leads the world effort to fully sequence the rice genome.

The human genome project has origins in the early 1980s with genetics programs in Japan, and these genetics programs have been increasing, though with very little being spent on ethical, legal or social impact (ELSI) issues (12). In the 1998 government budget, US$149 million was allocated for genome research (13), and industry is also making significant contributions as in other research areas. For example, Takeda Chemical Company was the leading patent claimer in a 1995 survey of world patents on human gene sequences (14), and it also obtained exclusive rights to use of the genetic database bought by SmithKline Beecham from the Institute for Genomic Research in 1992.

2. Public acceptance of biotechnology

The public acceptance of biotechnology in Japan is reasonably good, falling in between countries like USA and countries like Germany (1, 7, 15). I have conducted a number of studies on public acceptance since 1991, which describe the bioethical concerns that different groups have within Japan towards biotechnology applications. Arguably, Japanese have the highest familiarity with the word "biotechnology" in the world. In 1991 two surveys found that 97% had heard of the word (7), confirmed by results of 94% in 1993 (1) and 89% in 1995 by Hoban (16). It is clear that there is at least high understanding of the word, and programs on genetics and biotechnology are to be seen on Japanese television almost every day, and in most major newspapers. There are many science magazines, though they have more feature reviews in the style of the English language Scientific American than of the New Scientist.

The importance of medical care, agriculture and aquaculture to human life is universal among large societies, which raises the questions, to what extent are the attitudes to the use of organisms to provide these goods, relationships with the organisms and ecosystems that provide them, and attitudes to the consumption of the products, universal. To answer these questions we are faced with a number of strategies. Firstly we can look at the use of organisms and new products in different groups inside each society and between them, for example, do people eat meat? Although meat was not eaten widely a few centuries ago, thought to be due to Buddhist influence, it is very difficult to find meals which are strictly vegetarian now. Do they farm animals in open spaces or in factory farms? Land constraints mean most animals are in factory farm situations, except in Hokkaido during the warm seasons. We have to standardise for environmental and economic conditions, and also look at the religious traditions.

The religious traditions include guidance on ethical issues, answers to problems that are faced around the world. In one sense looking at the end result of choices, the adoption of science and technology products, consumption, is the best description of acceptance of science and technology. However, if we only look at the consumption statistics we may still not understand the reasons behind the choices, and whether, for example, there was really much choice for the consumer in their home environment and society. The ideal model would say a consumer will determine what products are best, but this is arguably never seen in a world dominated by large commercial interests, trade groups and associations, and connections between producers, retailers and regulators. Given that Japan is not self-sufficient in any major species of food (even rice is imported for processed rice products), it is going to be dependent upon exporters. However, purchasing power means selection among suppliers and some new practices in air freight have been introduced, like techniques to import live seafoods and many fresh fruits and vegetables. Organic foods and pesticide-free foods have been increasing their market proportion, though surveys find this is from self-interest in health rather than environmental concern (1). Some supermarkets provide non-genetically modified soybean products, like tofu (bean curd), but most do not and it appears unlikely that there will be significant resistance to the products of GMOs.

Another strategy that is used to judge public acceptance is to seek the guidance of traditional wisdom of a culture in determining what should be adopted. Schmid in 1991 (5) observed that public acceptance of biotechnology is high, "reflecting a high level of education and information within Japanese society, and the specific way of reaching decisions, which usually involve lengthy discussions with all groups". However, if one asked the public if they had been involved in the decisions associated with the promotion of biotechnology, it is very doubtful if almost anyone would say that they had been involved. Decision-making in Japan tends to exclude the public (11), though certain applications of biotechnology like organ transplantation technology have introduced the idea of individual public choice in use of technology (17), as will be discussed below. The observation that the public strongly supports biotechnology is not to be conclusively found in "public" opinion surveys. As discussed in the final section to my chapter, there are some cultural values, but predominant among these may be not to cause a fuss with those you disagree with. Therefore, protest movements and opposition to technology tend to be very small, and lack unity, so there major impact is if the media covers them, and through the discussion forums of magazines, newspapers and television chat-shows.

The strategy that allows us to look at what individuals really accept, and the reasons they use, is survey research with them as individuals, sometimes supplemented by small group discussion forums. The surveys conducted in Japan, repeated in other Asia-Pacific countries (1), and elsewhere in the world, reveal an important distinction about the main concerns people have about biotechnology. An important part of bioethics is risk assessment, the analysis and prediction of risks. Bioethics combines risk assessment, the concept of avoiding harm, with an assessment of benefits, the concept of doing good or beneficence. The concept of risk in biotechnology involves both the potential to change something and the potential to harm (18). The extent to which a change is judged to be a subjective harm depends on human values, whether nature should be "intransient" or modified. Open survey questions in all countries reveal that the major determinant of moral acceptability of a technology is whether it is perceived to be unnatural, or morally acceptable (1, 7, 15, 19). Many want to protect nature, not because of its value or property, but simply because it is there.

In the 1993 International Bioethics Survey (1), when asked about specific developments of technology, including in vitro fertilization, computers, pesticides, nuclear power, biotechnology and genetic engineering, both benefits and risks were cited by many respondents in Japan, as in the other countries (Australia, Hong Kong, India, Israel, New Zealand, The Philippines, Russia, Singapore and Thailand). In Japan 74% saw biotechnology as worthwhile, less than 85% in the 1991 survey (7), but still at a high level. In both years 37% said that they had no worried about its development. 30% of those who cited a benefit in 1993 said it would help humanity, 19% agriculture in general, and 15% said it would help science (open comments placed into categories). About a half did not say any benefit or concern. In addition to those who saw it as unnatural, the major worry was of human misuse.

In the 1997 telephone surveys (15), a single question on the perceived impact of seven areas of science and technology was used. Comparisons with the data from the European Commission Eurobarometer 46.1 reveal that there is more optimism about solar energy, new materials and space exploration, in Japan (and New Zealand and Canada) but similar optimism towards computers, information technology, and telecommunications to the EU. However there is less optimism about biotechnology and genetic engineering in Japan (with New Zealand being even lower). 62% in Japan thought that biotechnology would improve the way we live in the next twenty years, 12% thought it would make things worse and 4% said no effect, with 22% saying they do not know; with 54% seeing genetic engineering as worthwhile, 12% seeing it as making things worse and 7% having no effect. In 1991 76% in Japan, thought that genetic engineering would be a worthwhile area in their country, while 20% were extremely worried about it (7). In 1993 57% believed that genetic engineering was a worthwhile area for scientific research, while 15% had a lot of worries about it (15%). In Japan there may have been no general trend against genetic engineering over time, unlike that observed in Europe (20) or New Zealand (15).

When people were asked in 1997 to examine what images came to mind from the term gbiotechnologyh, 8% expressed a concern and 4% expressed a positive view of science, but most people just mentioned something technical (15). There is strong support for the specific examples of environmental release of genetically modified organisms in all Asian countries (1). Plant genetic engineering examples are seen more favorably than microbes, animals or human applications (21), except for gene therapy for diseases like cancer, which is seen very positively in Japan (22, 23). Despite the concern expressed about genetic engineering, in 1997 35% in Japan said they would buy genetically modified fruits if they tasted better suggesting they do have postive images to products. However, only 8% thought current regulations are sufficient to protect people from any risks linked to modern biotechnology.

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3. Japanese law and biotechnology

There a few specific laws on modern biotechnology in Japan, but a series of regulations by different ministries. However, many scientists and people in industry claim that these regulations have inhibited research development, a different view from the public as seen above.

The modern Japanese constitution was drafted by the occupation forces after the Second World War, was reviewed by the Japanese government, and voted into force by the Japanese Diet (Parliament) in 1948. It has almost no changes since then, reflecting a trend for laws to become fixed. It includes thirty-one Articles on the rights and duties of the people. The right of people to life, liberty, and the pursuit of happiness, to the extent that it does not interfere with public welfare, should be the supreme consideration of the law and government (article 13). The Articles which are relevant to access to biotechnology include:

(1) Article 11. The people shall not be prevented from enjoying any of the fundamental human rights. The fundamental human rights guaranteed to the people by this Constitution shall be conferred upon the people of this and future generations as eternal and inviolable rights.

(2) Article 25. All people shall have the right to maintain the minimum standards of wholesome and cultured living. In all spheres of life, the State shall use its endeavors for the promotion and extension of social welfare and security, and of public health.

Article 25 assumes a welfare state, but does not have much legal meaning. It does not vest in each individual person a concrete right that can be enforced by the judicial process, as such type of right comes into force only through implementing legislation. There are six major Codes in addition to the Constitution. Many medical procedures and appropriate behavior are regulated by specific legal Acts. The Civic Code is concerned with family and inheritance and was completely amended after the Second World War. The Criminal or Penal Code includes some relevant Articles. When there is a more specific law and it conflicts with a general code the specific law usually takes precedence. Administrative guidance by government agencies and local authorities plays the more significant role in many of the biotechnology issues. The power in the guidance is that the Ministries have the power to grant licenses or permissions. There is little legislation on recent bioethical issues.

The basic philosophy of the Japanese health care system is universally mandated, government provided, health insurance coverage. There is little choice over which insurance scheme a person must join. Either employees must join the one statutory plan offered by their employers, or the self-employed persons plan administered by local governments or trade associations (24). By the year 2000, a public long-term care insurance program is expected, which will provide for some extra services for the elderly or chronically sick, such as home help, visiting nurses or day care (25).

The Preventive Vaccination Law established a national program for influenza vaccination since 1976. The Law was weakened in 1987 by removing its obligatory nature, and was further weakened in 1993 with the broadening of exceptions and the removal of provisions that penalized parents who failed to have their children vaccinated. Influenza vaccination is performed annually in children three to fifteen years on certain target groups. However, it has not been very effective, and has recently been recommended for younger students only (26). Since 1987 it has been easy for parents to refuse influenza vaccinations, resulting in large differences between different kindergartens, primary, and junior high schools. Between 1951 and 1965, 169 persons died because of reactions to vaccination. Articles 16 to 19-4 provide for a national compensation system with set reimbursements for injury. For example, in April 1992 a death was compensated by 20.5-million yen, with funeral costs of 140,000 yen. A pension after eighteen years of age was 2,925,900 yen for the 1st category of disability, and 1,910,500 yen for second class of disability (27).

A controversy erupted in 1993 over the high incidence (1 in 400) of side effects from a MMR (mumps, measles, rubella) vaccine made and used in Japan. It was withdrawn after the media released unpublicized government risk data. In 1994 no MMR vaccine was offered to children, because the government refused to use the United States vaccine, which has a twenty year history of safe use with almost no side effects. The scandal reveals that the Japanese Ministry of Health and Welfare has been attempting to encourage Japanese industry by not using a foreign vaccine, while risking public health with a vaccine with 100-200 times more frequent side effects. If children want to be vaccinated now they had to pay about US$80 for a vaccine that was previously free (27).

Another sign of the support for the biotechnology industry is the system of drug reimbursement, and the overuse of antibiotics in Japan. One of the embarrassments of the Japanese health care system is the corruption that is implicit in the way drug prices are set and reimbursement is made, and the contributions from pharmaceutical companies to doctors who use their drugs. The Japanese are the world's highest spenders on prescription drugs (28). Almost all general practitioners and hospitals have their own pharmacies for outpatients. Every two years the Ministry of Health and Welfare sets the gofficialh prices for all drugs. These prices are used to determine the charges to patients and the national health insurance systems. However, pharmaceutical companies offer drugs to hospitals at a discount. The permitted discount is 10%, which means there is even official sanction of the scheme to have financial reimbursement for dispensing prescription drugs. In practice the current discounts are 20-30%, or more in competitive markets. This means that hospitals and doctors benefit from prescribing drugs, and explains why the consumption of drugs is so high.

The average use of antibiotics is three times the USA average and twenty times the United Kingdom average (27). There is concern over methicillin resistant Staphylcoccus aureus (MRSA) infections and deaths, which are relatively common in Japan. In one old person's home in Chiba, Japan, twelve patients out of eighty were infected with MRSA in 1992. Many products are allowed to support the presence of a large local pharmaceutical industry.

Before a new drug is approved for use, the Central Pharmaceutical Affairs Council within the Ministry of Health and Welfare must examine the results of toxicity tests, animal tests, and clinical trials. The basic policy is outlined in the Notice, No. 645 of 1967, on "Control of the manufacture of and trade in pharmaceutical products: approval of manufacture and import of medicaments". Drugs must pass three phases of clinical trials:

(1) Phase 1 is to check a drug's safety in humans;

(2) Phase 2 is to access its therapeutic index (the response rate and severity of side effects) in selected populations of patients for whom the drug is intended; and

(3) Phase 3 is to determine whether the new treatment is better than existing ones.

All these tests are done at universities or research organizations at the request of pharmaceutical companies, and there have been cases of bribery (27). There is pressure today for more of the trial results to be presented in scientifically refereed journals, but until now much of the data has been either in internal documents or in the drug companiesf own journals. International standardization of tests in 1991 in USA, Europe, and Japan avoided some duplication of tests and halved the length of long term studies. In practice, when a drug has passed phase 2 trials it may be widely prescribed in gtrialsh, and there are some top-selling drugs which are said to be anti-cancer drugs that are only prescribed in Japan (28). The phase 3 trials can become part of the pharmaceutical companiesf marketing plan. There are also widespread issues of lack of informed consent in such clinical trials at the phase 2 and phase 3 level because most patients do not know what medicine they are being given.

The government can suspend production by a company if it fails to report details of clinical trials, especially if these involve deaths. On May 20, 1994, the chairman of Japan's fourth largest pharmaceutical's wholesaler, resigned to take public responsibility for insider trading among employees, and for the sale of sorivudine, which has led to the deaths of eighteen people. The company had reached settlements with 10 of the 23 families of patients who died or had serious consequences as a result of using it, by May 1994. The penalty of a 105 day suspension of production at the Nippon Shoji Kaisha Ltd. Okayama prefecture factory in response to the company failing to report the deaths of two persons during clinical trials of sorivudine occurred on 2 September, 1994. This is the longest suspension of products because of an infringement of the Drugs, Cosmetics and Medical Instruments Law that has ever occurred (29). It also gave time for reflection on the system of clinical trials in general (30).

The journals that publish the results are often the same journals that sponsor the trials or make the drug (30), and all major pharmaceutical companies are also involved in research on production of new drugs using modern biotechnology methods. Another feature of Japanese biotechnology is that most research is conducted in large established companies, usually multinational, rather than the small biotechnology companies that are a feature of North America. However, perhaps the sponsorship links are just more obvious than it is elsewhere.

Despite the blood donation system, which in 1991, saw 8,861,137 persons donate blood, 6.5% of the population, there are also large imports of blood, as Japan uses more blood per person than any other country in the world. The Product Liability Law passed unanimously by the National Diet on 22 June 1994 came into effect from 1 July, 1995. It will virtually exclude any liability on transfusion products. "Complications of blood transfusion such as those caused by contamination of viruses whose complete removal by existing technology is impossible cannot be considered as product defects" (31). There have been compensation claims paid to some of the blood transfusion victims of delayed implementation of heat treatment procedures to eliminate HIV from imported blood products (32).

Patent claims on products in Western countries are recognized in Japanese patent cases, and there have recently been cases involving the use of recombinant DNA products. The approval of such products is independent of the patent claims. A Japanese court rejected a claim by Hoffman-Roche that a Japanese company infringed its patent on interferon, but the case will be appealed (27). The sales of interferon are rapidly rising since it was approved for use against chronic hepatitis C. An Osaka local court in January 1991 decided that the company Toyobo cannot market tissue plasminogen activator (TPA), because it conflicts with the Japanese patent given to Genentech in January 1991. Genentech licensed two other companies to sell TPA in Japan. TPA has been sold in Japan since May 1991. The case involving the rights to sales of erythropoietin (EPO) in Japan was solved out of court. EPO is also a very large market in a country where kidney transplant rates are low.

Privacy of communication is guaranteed in the constitution. Article 21 of the constitutions guarantees freedom of assembly and association as well as speech, press, and all other forms of expression. Censorship is prohibited and secrecy of any means of communication must not be violated. There is the Law on the Protection of Computer Information on Individuals, which states that government agencies are prohibited from using the information on individuals for purposes other than the original purpose for which the files were compiled. Any person may require a government agency to disclose the information on themselves that is stored in the computer, and if necessary, demand its alteration. It could be interpreted to mean the truth of any health check information entered into a computer must be revealed following a person's request.

If someone informs others of the medical data of a person, for example, the result of genetic screening test to an employer, section 134-1 of the penal code could apply. If the person who leaked the information is a national employee they will be punished by the Law on Government Employees. There is still debate over how to control life insurance companies questioning on the results of genetic tests, but other family history data and smoking, can be used in deciding policies.

For any medical intervention, physicians are required to obtain consent to medical treatment according to the Medical Practitioner's Act, Article 23. The Supreme Court, in 1949, (decision 3.1.) said that the obligation for treatment is based on assessing what can reasonably be expected in view of the knowledge and experience that ought to characterize the average physician. However, in practice and in court cases in the 1980s and 1990s, the doctrine of informed consent has yet to be fully recognised (33, 34), as a right for patients to be told all information. However, an increasing number of doctors are using informed consent, and truth telling in cancer cases has also been increasing (35).

Organ transplantation using cadaver donors, especially those that are determined to be dead by brain death criteria, is rare. A law permitting such transplants, and allowing whole brain death criteria to be used for determination of death if patients themselves have signed a donor card to that intent, and if family members do not object to it, was passed in 1997. Until then, Law No. 64 (article 4.17) enabled cornea transplantation since 1958, while in 1979, the Act Concerning the Transplantation of Cornea and Kidney was passed allowing kidney transplants. Kidney transplants since 1979 have been from both live and dead donors, with prior consent and family approval. In the mid-1990s there were few from brain dead donors while the new organ transplant law was being debated. There was much discussion of the issue and whether it was related to any particular Japanese ethos or just suspicion of the medical profession (12, 17, 36). From 1968, when the first heart transplant was performed, until 1997 there had been wide debate on the question in Japan, which was a rare, if not unique, occasion for extensive public debate on a biotechnology process. Live liver donations were conducted, but otherwise patients had to seek heart and liver transplants overseas.

Until 1996, the 1948 Eugenic Protection Law governed the use of abortion services in Japan. The number of abortions conducted is declining, but it is still high among developed countries, and in 1996 the title was changed to Mother's Body Protection Law (37). After World War II, the Japanese Government changed the population policy into "to stabilize and not to increase" from "to increase". How to popularize family planning became the No.1 policy in health care of postwar Japan, and at the same time, the Eugenic Protection Law was promulgated in 1948, and Japan became the second largest populated country after the Soviet Union in the semi-liberalization of induced abortion.

The Eugenic Protection Law was a combined law of a modification of Preventive Law of Offspring with Hereditary Diseases (das Gesetz zur Verhuetung erbkraanken Nachwuchses), 1933 of Germany under Hitler, with a semi-liberation of induced abortion (37). In June 1996, however, some inappropriate parts of this law were amended by the omission or elimination

of eugenic articles, and the title of this law changed from Eugenic Protection Law to Mother's Body Protection Law.

Fetal diagnosis and selective abortion is not explicitly allowed under these laws, however, widely practiced as it could cause psychological distress to the mother, or economic hardship, both of these being acceptable reasons under the law for induced abortion. The marketing of genetic diagnosis and triple marker biochemical tests is governed under existing laws for pharmaceutical products and devices. Abortion is restricted to the period in which the fetus is not viable outside of the uterus, and this period is determined by the notification from the Ministry of Health and Welfare, currently being 22 weeks. The Japan Society of Human Genetics has voluntary guidelines on use of genetic screening (38).

In vitro fertilization (IVF) and assisted reproductive technology for married couples are guided by the voluntary guidelines of the Japan Society of Obstetrics and Gynecology (JSOG), and moves to introduce a law have been resisted by the medical community (39). The first baby was born after IVF and embryo transfer (ET) in 1983, and there was much media attention. There are significant differences in attitudes between infertile couples, medical practitioners and the general public on the technology (1, 7, 40). Most Japanese obstetricians belong to JSOG, and after the first baby was born they rushed to form an ethical committee concerning IVF/ET. This committee consisted of 14 members of JSOG. While listening to the opinions of representatives from the mass media and highly educated, in October 1983, they wrote and announced a statement to the society of Obstetrics and Gynecology. Even though it was a little too late, this was probably the first time that a medical society made and announced ethical guidelines for its members. The statement is as follows (27, 37):

1. The Method should only be used for women who are judged unable to become pregnant by any other medical method.

2. The individual implementing this Method must be a qualified doctor who has mastered a high standard of knowledge and technology in the field of reproductive medicine. Every procedure and treatment should be carried out with the utmost care. The procedures and expected results of the Method should be sufficiently explained to the applicants concerned prior to implementation of the Method. Upon obtaining consent from the applicants, and acknowledgment should be filled out and signed by the applicants and retained by the doctor.

3. The applicant receiving the Method should be married, have a strong desire for a child, and be in satisfactory mental and physical condition for pregnancy, delivery and raising of a child. It must be possible to successfully conduct retrieval of mature ova, implantation into the uterus and maintenance of pregnancy.

4. The fertilized ovum should be carefully handled in respect to the basic moral values of life.

5. When implementing the Method, no gene manipulation is permitted.

6. The privacy of the couple and their delivered child should be respected and protected according to relevant laws and regulations.

7. Considering the importance of the Method, the organization using it should provide opportunities to hear opinions from individuals other than those directly concerned."

The number of babies born through IVF/ET is about 14,000 since the first case in 1983 in Japan. A total of 22,000 couples underwent procedures for IVF/ET at 236 medical facilities by autumn 1995 according to the Japan Society of Obstetrics and Gynecology (37).

Surrogacy is however, not permitted, though foreign surrogacy agencies have been used by Japanese clients, and at least two agencies operate for United States surrogacy businesses in Japan (27).

Artificial insemination by donor sperm (AID) is conducted largely through the Obstetrics and Gynecology Department of Keio University, Tokyo. AID has no law to regulate it, and it started in 1948 (37). Now there are about 500 attempts at AID a year at Keio University, and about 250+ births per year. Each sperm donor is used for up to fifteen pregnancies, and only married women are accepted. Keio University is the most public about its program. Other institutes do not admit having a program. The guidelines used are those of Keio University and Japan Society of Obstetrics and Gynecology. Since a conference discussion of the Japanese Association of Civil Law in 1953, many legal scholars have construed the law to allow the AID baby of a married woman to be a legitimate child of her husband, so long as the procedure was carried out according to the current practice, but there is still no specific law.

Preconception sex selection has been investigated in Japan, but in a 1993 survey, 76% said that if they had only one child they would want a girl, suggesting that traditional ideas of family inheritance are discounted by many people (27). The reason why more people wish to have a girl than a boy, which is in contrast to many other Asian countries, may be because girls are considered more cute, or better care-givers for elderly parents. Following its announcement in 1986, the Ethical Committee of JSOG, and at the same time, the newly founded Ethical Committee of the Japan Medical Association (JMA) came to about the same conclusion in September 1986. That is, that it was decided that this procedure should only be adopted to prevent the conception of conceptuses with severe sex-linked recessive genetic disorders.

The details of the Ethical Committee of JSOG's statement are as follows (37):

1. Any individual implementing the Method must be a qualified physician who has mastered a high standard of knowledge and technology in the field of reproductive medicine.

2. A physician intending to implement the Method must be previously registered with the Society according to the specified format. It is also desirable that the results be reported to the Society.

3. Before application of the Method, the physician should sufficiently explain the procedures and expected results to the individual(s) concerned, and should obtain their written consent.

It is also against the guidelines of the Ministry of Health and Welfare to generally inform parents the sex of the fetus during routine prenatal ultrasound diagnosis.

The Ministry of Health and Welfare in Japan set up a special Ethics Committee to assess applications for gene therapy in 1994. The Ministry of Education also made guidelines and set up a separate committee (with 7 overlapping members). In university hospitals, drugs already need the approval of both ministries, and so will gene therapy. The first protocol was approved by Hokkaido University in 1994 allowing research on one child with ADA deficiency. Approval was given by both ministries. The guidelines are basically those of the National Institutes of Health in the United States of America. The guidelines rule out germ-line therapy, and limit cases to terminal illnesses without effective therapy. However, they only require verbal informed consent, not the written consent that may be determined by local hospitals policies. Japanese scientists and public strongly support the use of gene therapy (22, 23), however progress has been slow due to regulatory delays. There is also a lack of domestic vector production, and many trials that are considered are in collaboration with US companies. Japanese people disapprove of use of enhancement genetics in surveys, unlike tendencies seen in China, India or Thailand (23).

In Japan by 1994, DNA fingerprinting had been used in 180 criminal investigations, but it had only been used twelve times as evidence (27). It is more common to use blood typing and other methods, but it is being introduced in the same manner as other modern forensic techniques. By 1997 advertisements to fathers to check the real genetic relationships to children had appeared in popular magazines, without apparent regulation.

4. Japanese culture, biotechnology and bioethics

The data from modern public opinion surveys needs to be interpreted in the context of the cultural heritage of Japan. The relationships between human beings within their society, within the biological community, with nature, and God, are seen in prehistory, therefore we cannot precisely define the origins of bioethics. One of the major elements that needs to be considered in Japanese bioethics is the history of polytheism, and animism. However, during the expansion of agriculture and paddy fields in the past 500 years they have seen similar disregard for the environment as in Western countries, suggesting that this religious belief did not overcome economic or self-interest (41). The decision to burn a forest and plant a crop is a bioethical decision, and we can see almost all possible land is utilized for agriculture, industry or urban live, with a lack of wilderness areas except for those areas difficult to exploit.

Japanese ethics is a mixture of Buddhist and Confucian influences combined with Shinto influence, and more recently Western influences. From the fifth and sixth century the medical profession has been restricted to the privileged classes. With the centralization of government in the seventh and eighth centuries there was a bureau of medicine established, with the Yoro penal and civil codes creating an official physician class. Because of shortages of doctors there was room for some others. After the Heian period (800-1200) the government-sponsored health service was replaced by professional physicians. In the sixteenth century a code of practice was drawn up that is very similar to the Hippocratic code, called the Seventeen Rules of Enjuin (42).

In all areas of public policy, committees of experts work in coordination with bueracrats, to issue reports and guidances. There is a Ministry for the Environment that attempted to introduce a law to govern genetic engineering in 1992, but it was blocked in a power struggle by resistant academics, and the Ministries for Agriculture, Forestry and Fisheries, Ministry of Education, Science, Culture and Sports, Ministry for International Trade and Industry, Science and Technology Agency and the Ministry of Health and Welfare, who all have there own regulations and committees on biosafety and release of GMOs (7). The first two guidelines had been introduced in 1979 by the Ministry of Education, Science, Culture and Sports, and the Science and Technology Agency. In 1986 following the OECD recommendations, the other three ministries also introduced guidelines. Given the interministry division of duties, it is not surprising that the smaller, then Agency for the Environment, could not push through a law claiming it had jursidiction for all GMO releases over the other ministries. Each of the ministries has revised their guidelines gradually, but has keep control over their traditional areas, the same as other biotechnology applications and research.

For medical discipline, in addition to the Ministry of Education, Science, Culture and Sports, and the Ministry of Health and Welfare, there is a Council of Medical Ethics established under the provisions of Article 25 of the Medical Act. It is an advisory body supervised by the minister of public welfare, consisting of the presidents of the Japan Medical Association, the Japanese Dental Association, and scholars and staffs from related administrative departments. It functions to take administrative measures to eliminate physicians and dentists who commit malpractice or act unethically. If the media exposes a scandal then usually top officials or Ministers must resign, a committee may be established, and then there is a proclamation of policy change. However, Japanese politics is dominated by long term stability, as the ruling parties and coalations have been in power except for a year since the Second World War.

Currently Japanese medical ethics is under change (33), recognizing that Japanese society contains people with a similar diversity of views to Western countries. The hesitant introduction of bioethics is more related to the structure of Japanese society than to any difference in individual person's attitudes between Japan and Western countries (11, 17). This can be shown from the results of opinion surveys, for example, when individuals were asked to give their reasoning for their opinions over bioethical issues such as genetic manipulation or screening. There was at least as much variety in opinions expressed by members of the general public in Japan as there are in other countries (1).

It must be noted that in terms of equity of access to biotechnology applications, apart from access to prenatal genetic screening and gene therapy, and novel treatments for rare diseases, most other applications of modern biotechnology are accessible to all under the universal medical coverage system. There have been criticisms of the health research system in Japan (43), but open debate is still not common and this may be the greatest public policy need in biotechnology.

5. The future and trust

In summary, considering the two sides of bioethics, descriptive and prescriptive, a key issue is trust. If we describe the ethical issues that people think are associated with biotechnology in Japan, we find great diversity, the same as in other countries. One common feature however, is a lack of trust in the process and the actors in policy decision-making. The prescriptive ethics, or processes that can be used to make decisions, and/or the range of decisions that can be made, has been influenced by the relativism that is perceived as correct in Japan. This means rather than one absolute view being right or wrong, we should respect the view of others and not challenge them. This is also enshrined in the constitution and also the spirit is preserved in the choices given over acceptance of brain death to organ donors (though the family can override the decision of an individual).

While people should not judge, policy must be formulated. What is good for one person may not be good for the broader society, and the global nature of agricultural economics and environmental impact, mean we have to think far beyond the small field trial of a GMO. Prescriptive bioethics not only calls for certain factors to be included in decision making, but that certain groups of people to be involved. Different groups of people may call for different levels of risk assessment, and in what constitutes a significant risk. Therefore a central question is who can be trusted, and how the public in Japan can regain trust in authorities.

In the 1997 survey, when given a range of bodies, international organizations like the UN and WHO were considered the best placed bodies to regulate modern biotechnology by 62% in Japan, compared to 34% in Europe (15), reflecting another cultural value, that the opinions of those outside the country may be more trusted than the opinions of policy makers within the country. Europeans and North Americans prefer their local authorities. Therefore the legal tolerance limits of acceptable risk and harm as broadly outlined in international covenants such as the Declaration of Human Rights, UNESCO Universal Declaration on the Human Genome and Human Rights, and international treaties on environmental protection, have been well accepted as a cultural norm and something to aspire to. Japan is less likely to break with world opinion than for example, the USA, which regards national autonomy as a higher ideal.

In the same question, industry was more trusted to regulate modern biotechnology than public authorities, the reverse of other countries surveyed (15). This may reflect that by 1997 there was very little trust left in the government in Japan, not that industry is very well trusted when compared to consumer organizations or university scientists. In the 1991 survey, when asked how do you think biotechnology should be regulated, 62% of the public chose the option standrads and practices agreed upon jointly by industry and government, with 19% saying by the government alone, and 2% by industry alone, and 5% by individual researchers (7). There was more support for government expressed by scientists or high school teachers also surveyed in the same survey.

This distrust of authorities does not stem from lack of knowledge, and the surveys of the different groups in Japanese society found that educated people show as much concern, in fact biology teachers considered there was more risk from genetic engineering than the ordinary public (7, 15). The risk perceptions among scientists had some tendency to be more concrete than in the public, but all groups expressed a considerable variety of concerns, and in related questions on the risks of genetic engineering of animals and humans, in that survey still 16% gave concerns that it was interfering in nature (7). However, in Japanese academics, industry and authorities, as in most countries, there are still claims that increased knowledge is correlated to decreased perception of risk. This is not supported by empirical studies. This balancing of good and harm is necessary for bioethics, and I have called this one indicator of the bioethical maturity of a society (44). The use of surveys can provide us with some indicators of the degree to which society can make well-thought out "mature" decisions, rather than impulsive "childish" decisions based on immediate gain.

In late 1997, one of the government agencies, the Council for Science and Technology of the Science and Technology Agency, established a bioethics committee, and a special committee to consider legislation on human cloning (45). They however, have been criticized for having the meetings closed to the public, despite saying the universal response of all ministries to a problem, gopen and nationwide debate and public consensus is neededh. Many in the public however, are aware that the debates do not reach to the public, but rely on opinions expressed by selected experts. Several Ministries have started having open meetings to the public in bioethical issues like brain death and gene therapy, but otherwise most meetings stay closed.

Bioethical decision-making involves recognition of the autonomy of all individuals to make free and informed decisions providing that they do not prevent others from making such decisions. This is consistent with democratic principles, and the extent to which a society has accepted this is one criteria of the success of bioethics. However, the structured paternalism of Japanese society is built on the idea that only the views of so-called experts (sensei) should be heard (11). It also means that their views should not be questioned, in accordance with the traditional paternalistic Confucian ethos. Medicine is "an Article of Jin", the expression of loving kindness (Jin) by the health care professional (32). The main theme of Confucianist ethics was the maintenance of moral discipline for the nation, society, and the home, and it was to the benefit of rulers and family leaders. Therefore, it is not surprising that many of the authorities in Japanese society share this ideal because it means respect for them, and hence reject autonomy-centered bioethics (11). They may promulgate the idea that Japanese are different as an attempt to prolong the Confucian ethic.

The bioethics debate may be the catalyst required to transform Japan from a "paternalistic democracy". People of any country may resist the rapid change and globalization of ethics, ideals, and paradigms, as ethnic and national identities may be changed, or lost, especially countries with such a long history of culture. How countries approach globalization is a fundamental question, but many individuals in countries with access to common news media have already answered the question by their converging lifestyles and values. To the extent that human rights and the environment are more respected, this trend is to be encouraged.

When Japan opened its doors to Western society last century it led to the introduction of a newly emerged science and scientific paradigm, only part of the fabric of Western society. Meanwhile, Western society has continued to evolve, and bioethics has emerged. There has been a series of meetings on bioethics developed in Japan, both through the Japan Association of Bioethics founded in 1987, and through a series of international seminars on topics such as the human genome project (46-49). There are several bioethics centres, and university departments at which it is possible to do research in bioethics, but no degree course specialised only in bioethics. The early part of this development included importing and developing ethical approaches which can be debated, but the current phase is the involvement of multidisciplinary dialogue and the public in discussion and development of indigenous diversity of ethical traditions. Modern biotechnology may be the stimulus to transform Japanese public policy over public involvement in technology decisions.

References

Please note the references by Macer are available on-line on the Eubios Ethics Institute Internet site <http://eubios.info/index.html>.

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