In Japan, there is less consensus on the use and regulation of biotechnology than is generally assumed. Legal protection of plant varieties is currently under debate, and Japanese consumers have expressed their concerns about genetic engineering research. At the same time, consumers might be reluctant to buy products of genetically modified organisms. Their doubts have resulted in a slow­down of biotechnology R&D in the field of food processing and agriculture.

In general, the word 'bio' has a positive connotation in Japan, and has been used as a functional marketing argument for an array of products including 'bio­candy' and 'bio­lipstick'. It is generally assumed that the Japanese would be more open to biotechnological products than Americans or Europeans. However, the results of a survey carried out in 1993 by Darryl Macer and Yuko Kato and colleagues of the University of Tsukuba (Japan) do not support such optimism. The results show that the vast majority not only express appreciation for the research on biotechnology and genetic engineering, but are also concerned about its possible adverse impact. 74 Per cent of the Japanese consider biotechnology as a worthwhile research area. The appreciation of research on genetic engineering is clearly lower: 57 per cent consider this research to be beneficial. But the majority also express concerns (to a different extent) about the results of biotechnology and genetic engineering research (see table). In an answer to an open question, the concerns most frequently raised were the danger of human misuse, interference with nature, and ethical concerns with respect to genetic engineering.

Consumer acceptance
Apart from Japanese attitudes towards scientific research, an activity that for most people might be rather abstract, it is interesting to know whether the Japanese would be willing to use products produced by genetically modified organisms. On average, the concerns towards the consumption of this type of food and medicine are somewhat greater than towards genetic engineering research (see box). Between 14 to 24 per cent (depending on the product) of the respondents in the survey said they had no concerns at all. The vast majority of the respondents, however, expressed concerns to a differing degrees, especially regarding safety, quality, unknown health effects, long­term risks, unnaturalness, and lack of information.
Consumer acceptance is critical for the Japanese agro­biotechnology industry. The Japanese consumer seems to have a preference for familiar, traditional food products. For example, rice consumption in Japan has often been linked with religion and culture, and the most consumed rice variety is more than 30 years old. The dominance of this preference is illustrated by the fact that, during Japan's poor rice harvests in recent years, Japanese consumers were willing to pay up to ten times more for rice from Japan than for rice imported from Thailand.
Consumer preferences could be disastrous for companies that have invested in research on recombinant rice, but also for the biotechnology food industry in general. Until now, the food industry has not taken the risk of linking their major brands with the image of genetic engineering. This might explain why Japanese food processors like Suntory and Kirin do heavily invest in biotechnology research on non­food crops such as flowers, but hardly in brewing, their core activity. "We think flowers will gain public acceptance sooner than foods" says a manager of Kirin's laboratory in Science.
Also the Japan Bioindustry Association (JBA) envisages public acceptance of biotechnology as an important issue for the future of the Japanese biotechnology industry. Together with the Science and Technology Agency (STA) it has spent significant amounts of money on public promotion of biotechnology in Japan, including public meetings on biotechnology, advertising efforts through the media, pamphlets, and preparation of teaching materials on biotechnology for high­schools. Since most of these efforts took place before the above mentioned survey was carried out, they apparently did not succeed in taking away the general public's concerns, or the general feeling of lacking information. A major reason for this failure could be the very limited faith of the Japanese people in information provision by government agencies and biotechnology companies on biotechnology products. In the same survey, the general public expressed a greater confidence in information provided by consumer agencies, environmental groups, and university professors, but these groups are hardly involved in the diffusion of information on biotechnological developments.
 

Public perception in 1993 regarding research on biotechnology and genetic engineering, and the use of substances produced by genetically-modified organisms  Attitude towards research on Use of substances items produced by genetically modified organisms Biotechnology Genetic engineering Dairy products Vegetables Meat Medicines No concerns  37 22  16 24  14 22  Few concerns  44 39  40 42  39 39  Some concerns  14 24  26 19  28 20  Lot of concerns  5 15  18 15  19 19  Source: Darryl Macer (1994) Bioethics for the People by the People. Christchurch, New Zealand/Tsukuba Japan: Eubios Ethics Institute, pp.195, 198, 199.

 
Biosafety regulations
In order to regulate the laboratory experiments and field tests of genetically modified organisms, guidelines have been established by several Japanese institutions. In 1979, guidelines on recombinant DNA experiments were issued by the Ministry of Education, Science and Culture (MESC), the authorizing body for genetic research within universities and colleges, and the Science and Technology Agency (STA), the body with a similar function with respect to genetic research within companies and other research institutes. These guidelines cover all basic research. The next experimentation stage, including the tests for the practical use, are regulated by separate guidelines of the Ministry of Agriculture, Forestry and Fisheries (MAFF), Ministry of Health and Welfare (MHW), and the Ministry of International Trade and Industry (MITI), depending on the product.
From 1988 to January 1995, 20 transgenic crop plants were tested in Japan in contained and semi­contained green houses. Of these 20, 6 varieties (including Calgene's Flavr Savr tomato, the world's first commercialized genetically engineered plant) passed isolated field tests. Only 4 varieties of these 6 also completed an application test in open environment (ordinary field), which is the last stage of the entire testing process. These 4 crops include a Tobacco Mosaic Virus­resistant tomato, developed as a model plant by MAFF, 2 Rice Stripe Virus­resistant rice varieties developed respectively by MAFF and Plantech Research Institute (a subsidiary of Mitsubishi), and a Cucumber Mosaic Virus­resistant Petunia variety developed by Suntory. Only the Petunia could be commercialized at the moment, since the rice varieties still have to pass a food safety assessment procedure under authorization of MHW.
Although the Japanese biosafety regulations for genetically­engineered plants are rather strict in relation to international standards, biosafety regulations in other areas are very weak. For example, biosafety regulations related to genetically­modified micro­organisms are mainly restricted to the requirement to sterilize the wastes of the experiments; this in spite of the fact that there have been more than 250 applications for large­scale fermentation of genetically modified micro­organisms and for cell/tissue culture. MAFF developed guidelines for the testing of small genetically­engineered model animals for research on human pharmaceutics, but livestock will be dealt with on a case by case basis.
 

Comparison of Japan’s Seeds and Seedlings Law to the UPOV Acts of 1978 and 1991    UPOV 1978 POV 1991 Act Japan’s Seeds and Seedlings Law 1982 Protection coverage Plant varieties of nationally defined species Plant varieties of  Plant varieties of all  genera and species Plant varieties of 245 genera, 202 species and 8 subspecies  Duration Min. 15 years Min. 20 years 15 years (trees and vines, 18 years) Protection of F1 hybrids Yes Yes Yes Breeders’ exemption Yes Yes, but marketing of essentially derived varieties  requires authorization  Yes Farmers’ privilege In practice: Yes Optional and under conditions  Yes, explicitly included Double protection  Prohibited  No provision, up to national laws No provision   Source: Seeds and Seedlings Law Japan, UPOV Convention.

 
Public concern about safety
In Japan, local groups have protested against the application tests of both plants and pharmaceutics. These groups of concerned citizens are all acting locally and lack direct influence on national policy making. Groups were formed in, for example, the city Tsukuba, a main centre of research in natural sciences, and Osaka. Probably the most important initiative has been the organization 'Citizen Against Genetic Engineering'. This group of local residents protested against the transfer of a laboratory of the Japanese National Institute of Health (NIH) to a residential district of Tokyo. Its main concern was the permit this Institute holds to carry out tests with genetically modified and other pathogens and laboratory animals (P3 level). Its protests, including a blockade of the construction site, clashes with police and finally a court appeal in order to halt the construction of the laboratory, have received attention in the Japanese media. The organization demanded that a thorough environmental impact assessment should be conducted, which is normally required for new factories in Tokyo, but which was not dictated for the NIH laboratory.
According to Darryl Macer, University of Tsukuba, the committees that decide on tests with genetically modified organisms in Japan mainly consist of scientists from both universities and industry, which is true of almost all Japanese committees. The general public is not represented in these committees, while most of the committee discussions are kept closed. Therefore, the public is unaware of the kind of tests that will take place, while public objections can only be made after the final decision. In countries like the UK, USA and New Zealand, public notification is required by law or regulation as part of the application to the release of genetically modified organism, in order to enable the public to express its objections.
In the opinion of Macer, the protests have led to a slow­down in biotechnology research in Japan, even though they are coming from a small minority of activists. He also thinks that the protests in Tokyo have influenced the policy of the Institute of Physical and Chemical Research (RIKEN) in Tsukuba to inform the public by open meetings and press releases on ongoing tests with genetically modified organisms in their facility for P4 level experiments (experiments that need total isolation from the environment and laboratory workers). It has been felt that more openness could increase local confidence in the procedures followed. However, no P4 level tests have been carried out by RIKEN since, which makes it difficult to assess what this openness means in reality.

Food safety regulation
Food safety guidelines are now under consideration. MHW is expected to launch a second draft of these guidelines shortly. Essential in the guidelines on food safety is in which way the new biotechnologically modified food is different from already existing ones. Japanese food regulations will be based on those of the Organisation of Economic Co­operation and Development (OECD), which tend to look at the final components of the food item, instead of its process of production.
The first draft did not include regulation on labelling of genetically modified foods. The Consumers Union of Japan has asked for compulsory labelling in order to enable consumers to make the final decision whether they want to eat genetically modified food or not.
The need to establish regulation on food safety has grown not only because there are two genetically modified rice varieties which have completely passed field testing, but also because of a request by Canada whether Japan would allow future imports of genetically modified rape seed. Canada annually exports around 1.8 million tonnes (45 per cent of the total world trade) of rape seed to Japan.
Although food safety regulation does not yet exist in Japan, in September 1994 the import of chymosin (rennet) produced by a genetically­modified micro­organism has been cleared under the Guidelines for Food Additives Produced by Recombinant DNA Techniques. This chymosin, produced by Gist Brocades, the Netherlands, and Pfizer, USA, is the first allowed recombinant food application in Japan. Japanese dairy companies are not using recombinant chymosin, but, according to information of Gist Brocades, it is very likely that it is used in the production of imported cheese. In 1993, Japan imported 143,000 tonnes of cheese.

Patent regulation
In the Japanese patent law, there are no statements about possible exclusions of biological inventions. This means that, theoretically, all kinds of biotechnological inventions could be protected by patent law. At the moment, patents have been granted on micro­organisms, while also functional genes (genes that encode a known particular characteristic) are considered patentable. Plants, animals and simple gene sequences, however, are considered not to comply with the requirement regarding 'inventiveness' so far. Nevertheless, one patent on a pentaploid artemisia with a supposed medical application was granted in Japan before Japan adopted plant breeder's rights, and one patent was granted on a genetically engineered mouse used in cancer research (onco­mouse).

Plant breeders' rights
Since 1982, Japan has been a member of the International Union for the Protection of New Varieties of Plants (UPOV). Plant breeders' rights (PBRs) have been protected under Japan's current Seed and Seedlings Law, which is based on the 1978 Act of the UPOV Convention. The new 1991 Act of UPOV has led to lively discussions within government departments on the change of PBRs. As can be expected from the table summarizing the main characteristics of the two UPOV Acts and the Seed and Seedlings Law in Japan, the discussion centres on essentially derived varieties, prohibition of double protection, and farmers' privilege. When an essential derived variety, i.e. a new distinct variety which retains most of the essential characteristics of an existing variety, is developed, the original rights on the existing variety should be acknowledged. This is important when, for example, a new gene is inserted into an existing variety. Double protection, i.e. when one and the same botanical genus or species may be protected by PBRs and patents, in fact opens the possibility of patenting plant varieties. The prohibition of double protection has been deleted from the 1991 Act of UPOV and the issue is left to the decision of each member country. The farmers' privilege, i.e. the allowance of seed saving by farmers to sow their field in the next season, was not mentioned in UPOV 1978, but is common practice in Japan as in many other countries.
According to Mitsuru Miyata, editor­in­chief of Nikkei Biotechnology, the main actors in the discussion around intellectual property protection of plant material are on the one side the Patent Office of MITI, and on the other side the Seeds and Seedlings Division of MAFF. MITI is in favour of a strengthened IPR regulation for plant varieties, including patent protection, while MAFF supports PBRs including a farmers' privilege.
Because of the steadily increasing number of applications per year for variety protection under PBRs, MAFF concludes that the seed industry has appreciated the current PBRs system. Farmers have requested the arrangement of a farmers' privilege, with which also the smaller, family­based seed industry could agree. MAFF officials fear that under patent law not only the farmers' privilege would disappear, but that it also would have a detrimental impact on breeding, in which MAFF itself is an important actor. Although research on a patented variety is exempted, using a protected variety as a source of breeding is not. This is in contrast with the essence of PBRs, under which the breeding is exempted. Because of this conceived negative effect on the dynamics of breeding, MAFF does not agree to granting patents to plant varieties.
Interest groups, which are traditionally linked with one of the ministries mentioned above, are also involved in the debate around intellectual property protection and plant material. The national farmers' organization National Federation of Agricultural Cooperatives Associations (Zennoh) more or less shares the position of MAFF, while the private seed industry is divided on the subject of IPR regulation. Around a decade ago, several large industrial corporations have entered the plant seed industry with modern biotechnology as a vehicle. These companies, which have made important investments in genetic engineering of plants, are in favour of patent protection. According to Miyata, another group of established, mostly family­based breeding companies, are mainly involved in hybrid vegetable seeds, and therefore less interested in patent protection or the issue of farmers' privilege. These companies value their strength in gene stocks, plant breeding experience and their distribution network, things that the newcomers are generally lacking. The settled companies are behind in biotechnology investments compared to the large corporations, and expect that patent protection of plant varieties will mainly serve the interests of the larger breeders.

Impact of strengthened IPR
What would be the impact of strengthened IPR on Japanese farmers and on the Japanese seed industry? It would mainly affect farmers who grow genetically engineered varieties, while the effects on farmers of other varieties will be limited. The farmers' privilege seems to have become less important for Japanese farmers. Rice farmers, for example, hardly save seed. In order to save labour, most farmers buy rice seedlings and thus are not using the possibility of seed saving. In vegetables, hybrid seeds are important, while in fruit trees farmers themselves are responsible for a significant share of the breeding.
It is also important to note that the position of the Japanese public and private seed sector is to a large extent determined by types of regulation other than IPR. The most important is the Main Crop Seed Law, launched just after the Second World War to secure seed production and supply to farmers. This law excluded private companies from the seed production Japan's five main (food) crops: rice, wheat, barley, naked barley, and soya bean. In this way, this law might have been more determinant of the historical disinterest of the private seed industry in Japan's main food crops than perceived deficiencies in IPR legislation. A modification of the Main Crop Seed Law in 1986 enabled seed production by the private sector and therefore stimulated private R&D in these crops, but it includes the requirement that new varieties basically need approval of prefectural governments before their distribution. Therefore, this law is still felt as a restriction by the private seed industry.
 

Resistance to patents  November and December 1994 were bad months for Agracetus (USA). First their broad European patent on all genetic manipulation of soya beans was attacked separately by public­interest groups and Monsanto (USA). At the same time the US Patent and Trademark Office decided to start measures to evoke the US patent on all genetically engineered cotton. In all cases, the challengers' main arguments are that the broad patent grants the company a monopoly for years on important (food) crops, that it blocks research, and that it does not comply with the requirement of novelty (a condition to obtain a patent).  What happens further remains to be seen. In the case of the cotton patent, Agracetus had two months to respond. If this reply is not satisfactory to the patent examiner, the company can still appeal to the patent office and finally the US courts.  Sources: Rosie Mestel (1994), "Cotton patent left hanging by a thread". New Scientist, 17 December, p.4;  Sally Lehrman (1994), "Soy­bean patents comes under fire as threat to research". Nature, 8 December, p.448.

Outcome of the IPR debate
What the outcome of the discussions on IPR will be is difficult to predict. Miyata expects that a foreign patent application might lead to a break­through in this debate. An example could be Calgene's Flavr Savr tomato. Many patent applications of genetically engineered plant varieties have been made at the Patent Office, although the number of varieties that have entered examination is far less. However, since neither MITI nor MAFF have any experience with patent applications of recombinant plants, and no jurisprudence exists in this respect, it is unclear whether any of these plants will pass the requirement of 'inventiveness', which have prevented Japanese patents on plants to pass so far.
Peter Commandeur

Sources
Brian Eisenburger and Tokuo Yoshida (1994), Japanese Biotechnologies in the nineties. Tokyo: Royal Netherlands Embassy.

Darryl Macer (ed.) (1994), Bioethics for the People by the People. Christchurch/Tsukuba: Eubios Ethics Institute.

Darryl Macer (1992), Attitudes to Genetic Engineering: Japanese and international comparisons. Christchurch/Tsukuba: Eubios Ethics Institute.

June Kinoshita (1994), "Agricultural Biotech Blooms Late." Science, vol. 266, 18 November, pp.1184­1185.

J. Rus (1992), Plant Biotechnology in Japan. Tokyo: Royal Netherlands Embassy.

Several documents of the Biotechnology Division, MAFF.

Personal communications with Koyu Furusawa (Mejiro Gakuen Women's College), Kazuoki Ono (Rural­Urban Alternatives), Keisuke Amagasa, Darryl Macer (University of Tsukuba), Mitsuru Miyata (Nikkei Biotechnology), C. Repelius (Gist Brocades, The Netherlands), Teruyoshi Ota and Hiroki Tanaka (Seeds and Seedlings Div., MAFF), Yasuda Setsuko (Consumers Union of Japan), and Makoto Tabata (UPOV, Geneva).