Bioethics: Perceptions of biotechnology and policy implications


International Journal of Biotechnology 3 (2001), 116-33.
Author: Darryl R. J. Macer

Institute of Biological Sciences, University of Tsukuba, Japan

Abstract

Modern biotechnology has already had a great impact on medicine and agriculture. It is important to see these benefits and risks in an international way because the world is becoming smaller and ever more interdependent. Overall, most people in industrialized countries perceive more benefit than harm from science and believe that improved quality of life depends on scientific knowledge. This paper looks at the public awareness and concerns over biotechnology expressed in surveys around the world, discussing the implications for education and information. The issue of risk assessment for environmental release of genetically modified organisms and safety of foods made from these is assessed. The issue of equity and patenting of living organisms is discussed, as well as public opinion over patenting of life. The future challenges of biotechnology policy are debated.

Biographical Notes

Darryl Macer obtained his Ph.D. at the Medical Research Council Laboratory of Molecular Biology, Cambridge, England. He was a consultant to the New Zealand DSIR and the Ministry for the Environment, and since 1990 has been at the Institute of Biological Sciences, University of Tsukuba, Japan, where he is an Associate Professor. He is a member of the UNESCO Bioethics Committee; and the Human Genome Organisation Ethics Committee. He is Founder of the Eubios Ethics Institute, and has written or edited more than 10 books, and written over 100 papers on bioethics since 1989.

1. Biotechnology and genetic engineering

There is a lot of genetic engineering research being performed worldwide. Some applications of genetic technology are already being used in daily life. Modern biotechnology has already had a great impact on medicine and agriculture. It's impact is not limited to the technical impact that these advances have upon industry, medicine and agriculture, but any technology influences society. Biotechnology has influenced the thinking of society, and paradigm shifts include the switch to biodegradable products, industrial pressures to restructure scientific information sharing, the paradigm of sustainable and limited economic growth, and the paradigm of intervention in nature rather than observation and participation in it. Biotechnology has also been a catalyst to the consideration of bioethical issues [1], and the two words, biotechnology and bioethics, have coevolved.

I take a broad meaning of biotechnology; the use or development of techniques using organisms (or parts of organisms) to provide or improve goods or services. Genetic engineering is one part of biotechnology and involves design of the DNA or an organism. Genetic engineering may be perceived as a technology that can bring many benefits, and it is also often perceived as a technology associated with many risks, and most people have both these feelings about it. Bioethics is the study of ethical issues associated with life, including medical and environmental ethics. It looks at benefits and risks, and also at balancing pursuit of individual autonomy with the duties of justice.

It is unclear who will really benefit the most from most applications of biotechnology [2]. It is important to see these benefits and risks in an international way because the world is becoming smaller and ever more interdependent. Biotechnology affects the lives of people throughout the world [3]. All people of the world can benefit if they can access medicines, and more environmentally sustainable agriculture. However, biotechnological inventions that allow industrialized countries to become self-sufficient in many products change the international trade balances and prosperity of people in and between developing and industrialized countries. If developing countries cannot export products because of product substitution the result may be political instability and war. This may in the end become the biggest risk. For example, the use of enzymatic conversion of corn starch into high fructose corn syrup causes serious damage to the economies of sugar exporting nations [4], and may already have caused political instability in some.

2. Development of biotechnology

The government and industry in most countries of the world promote modern biotechnology. This has been considered most successful in the rich triad, USA (and Canada), Japan, and Europe. Perhaps most simply they had the most capital to invest. The issue of equity is not unique to biotechnology, but has arguably been most stretched in the use of living organisms and genes because many of these resources come from developing countries. Japan promoted biotechnology throughout the 1980's and it has been predicted that by the year 2000, bioindustry will represent 10% financially of the Japanese economy (US$1.1 trillion (1 US$=Y115)) [5], though 90% of this may be in traditional industries such as fermentation of food and drink. The 1990 sales of products made using recombinant DNA technology in Japan were valued at US$1.1 billion [6]. The retail market for bio-products in 1991 in Japan was US$3.5 billion, up 29% from 1990. Just the sales of interferon for use against chronic hepatitis C added another US$1.3 billion in 1992. Erythropoietin to treat kidney disease is worth US$1 billion, because of a shortage of kidneys for transplants resulting from legal obstacles to the use of organs from corpses. Both these proteins are made in Japan under license to foreign companies, with Japanese courts recognizing the patent claims of foreign companies. The main investors are big companies, with few small biotech companies unlike the USA [7].

Japanese have the highest awareness of the word "biotechnology" in the world. This is the result of many years of soft education by industry and government, and the marketing use of "bio". Almost everyone uses biocandy or biodetergents. The prefix "bio" has been applied to many new words in common Japanese language, maybe more so than in the language of the public in most other countries. In two surveys in 1991, 97% said they had heard of biotechnology [8]. We can compare the results of the same question in New Zealand, where 57% in 1990 and 77% in 1993, said they had heard of biotechnology; and in a 1988 survey of 2000 public in the UK, only 38% of respondents had heard of biotechnology. The result suggests that the Japanese public is comparatively very well exposed to biotechnology, with 29% saying they could explain it, compared to 15% in New Zealand in 1993 [9].

The public in Japan has a high level of interest in science. Like people everywhere, Japanese perceive both benefits and risks from technology and believe that science will improve their quality of life. Over the past decade the understanding of biotechnology has increased, but the perception of benefits and risks remains similar. In the last few years there has been more discussion of biotechnology and bioethics in the media, with little measurable change in opinion. This high acceptance can be traced to 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). In 1989 the Science and Technology Agency also funds efforts on the public acceptance of biotechnology.

Public opinion surveys in all countries surveyed suggest there is a broad public consensus that genetic manipulation of plants and environmental release of disease resistant transgenic plants is acceptable. However, the speed of introduction has varied widely between countries. Japan was slow to start field releases of GMOs, but recently there have been some open field trials. Nevertheless we could say that the agricultural applications of genetic engineering are still at an early stage internationally. Agricultural biotechnology has been slower to develop than in North America, EU, Oceania or China, partly due to a cautious approach and bureaucratic regulations for field trials of transgenic organisms.

The development of different areas has also varied, depending on history and current use. For example, in Japan there is a long history of fermented foodstuffs and alcohol brewing, for sake and beer, and new yeast strains are being introduced. The fermentation industry is the strongest part of Japanese biotechnology, being a world leader in the production of antibiotics. Japanese use about 15 times the amount of antibiotics used in Britain, largely because doctors profit from the commission they receive for directly prescribing drugs, and the government retains financial incentives for Japanese pharmaceutical companies to develop new antibiotics. If people perceive a benefit and no risk than people of all ages will readily eat biocandy and wash their clothes in biodetergent.

The Japanese Ministry of Health and Welfare has released guidelines to assess applications for foods and food additives made from GMOs in 1992 [10]; followed by guidelines in 1995 when imports of US soybean products from GMOs were actually faced. Overall, despite the efforts to promote biotechnology, there appear to be some bottlenecks caused by strict or bureaucratic regulations, as also seen in the EU, which delayed importation of such foodstuffs while developing regulations. In both cases public debate was increased at the time of importation, rather than in anticipation. Public concern can also be triggered by local research centers, as in Japan [8], or environmental release of genetically modified organisms (GMOs) in the USA [11], or Europe. It may be eased by public notification of details of the research work, and public involvement on committees that oversee the research. The same groups promoting concern about environmental release have been leading these campaigns against food based on health concerns.

The concerns of some vocal groups against medical screening techniques has meant that despite strong support for the availability of prenatal genetic screening tests for serious diseases under national health insurance in Japan, they are not yet incorporated into general programs of prenatal care. In surveys I conducted, in 1991 and 1993, 57% said that they would personally use prenatal genetic screening tests for serious diseases [9]. There is less opposition to the use of genetic screening in Japan than in the USA. A majority of Japanese people would personally undergo gene therapy for serious diseases, and there was even more support for having their children undergo gene therapy, however, government gene therapy regulations were made in 1993, nine years after the USA. Regulatory systems, public opinion, and science, are all important but may have different influences between countries.

3. Attitudes to biotechnology

There have been a variety of international public opinion polls which have examined the level of interest that people have in science and technology, in addition to those looking at interest in biotechnology and genetic engineering. Young people tend to know more than old, and males more than females, but the strongest association is with education in Western people. The same is true in Japan [8]. These type of studies have at least two purposes, one being academic study, and the other being public relations for the biotechnology industry. Both of these purposes are relevant to policy.

There are also various strategies being used to study public opinion. One is use of fixed response questions, to chose from set answers, for example in the USA [12, 13], or the Eurobarometer in the European Community. In 1991 Eurobarometer 35.1 looked at biotechnology and genetic engineering, in 1993 Eurobarometer 37.1 repeated the same questions, and in 1996 Eurobarometer 40.1 developed a modified survey. Recent survey strategies in Europe look at reasoning more than just statistics [14, 15, 16] which may shed more light on the factors which will affect policy development. In New Zealand there was also a study using both set and open questions in 1990 [17]. In Japan a survey among public, academics, and high school teachers was carried out in 1991, in which I also reviewed all the previous studies in Japan [8]. In 1993 the International Bioethics Survey was conducted in ten countries using 32 open questions among 150 questions in a mail response method [9].

In these surveys I used open questions, and found that some arguments that are often used in biotechnology debates, such as eugenic fears or environmental risk, are not the major concerns voiced by people in open questions. The more common concerns are interference with nature or general fear of a less concrete nature. Also the survey found that many people perceive both benefit and risk simultaneously, they are attempting to balance these; and also educated people show as much concern, in fact biology teachers considered there was more risk from genetic engineering than ordinary public [8]. This result was confirmed for Japan in 1993, and the level of concern was similar in Australia and New Zealand [9].

Martin and Tait [16], conducted surveys of selected groups of the UK public. They conclude that groups with an interest in biotechnology have probably already formed attitudes to it, which are unlikely to significantly change. They looked at industry and environmental groups, and local communities, which are major players in the development of policy at both national and local levels. They also suggest that people with the least polarized attitudes are most open to multiple information sources. Consumer research in the Netherlands [15] conducted by SWOKA - an Institute for Consumer Research, has involved two major studies of what people in the Netherlands think about eating foods made through biotechnology.

Overall, most people in industrialized countries perceive more benefit than harm from science and believe that improved quality of life depends on scientific knowledge. A 1989 Chinese survey of 4911 people in Beijing suggests a positive image of science and technology in China also, though the questions were different and the responses were by questionnaires returned from relatives of middle school students [18]. People in all countries support more government funding of science. They also believe that science should be regulated more to protect public safety. However, they are suspicious of safety statements made by scientists, and especially statements made by companies. The main source of information about biotechnology is the media in all countries surveyed. The newspaper and television are the most cited, with the radio being common in some countries, like Thailand. The media have a large responsibility to communicate science, and scientists should also inform people about science. The media also has a responsibility to present balanced information, on the benefits and risks of alternative technology and to do this independently of commercial interests.

4. Environmental release of GMOs

There is a broad public consensus that genetic manipulation of plants and environmental release of disease resistant transgenic plants is acceptable. Open response survey questions reveal common concerns about biotechnology in Asia and Oceania [8, 9]. Unusual applications are seen to be against nature, or playing God, with more general environmental concerns and fear of human misuse, and concern about human health. The level of concern is higher in Japan than in Australia, New Zealand or the USA for general questions, but less in Japan for specific examples.

There is also consensus that the environmental release of disease or frost resistant plants bred using genetic manipulation, providing they present very remote risks to the environment, is acceptable. There is also a broad consensus support for genetic manipulation of microorganisms, and for the environmental release of bacteria geneticall modified to clean oil-spills, providing they present very remote risks to the environment. There is widespread belief that genetic manipulation of plants and microorganisms will provide many benefits, especially for agriculture and medicine. There is less concern about genetic manipulation of plants, than microorganisms, but there is substantially more concern about the genetic manipulation of animals and highest concern about that involving human cells [8, 9].

In the International Bioethics Survey [9] and the US survey of Hoban and Kendall [13], in all the countries in this survey, plant-plant gene transfers were most acceptable, with animal-animal next, and animal-plant or human-animal gene transfers being least acceptable. A similar trend was also seen in Canada. A variety of reasons were cited, as was the case in questions about the concerns of consuming products made from genetic engineering. One of the main concerns was that the products would be unnatural, but there were also a variety of other comments. The generally higher fears about animal genetic engineering, and meat, is also seen in Europe [14, 15, 19].

When specific details of an application were given there was generally greater acceptance, suggesting people have some discretion. It also suggests that if details are given the public will show greater acceptance of an application, for human gene therapy, or environmental release of GMOs. The approval of a modified tomato which has delayed ripening for general growth in the USA was given in 1993, and was approved for general commercial food consumption in many countries, is generally supported around the world [9].

A question on cows with increased milk received less support in the International Bioethics Survey than the goal of less fatty meat, which is consistent with the existing milk surplus in some countries. This case is a reality in many countries with the general use of bovine growth hormone (BST - bovine somatotropin) in the dairy industry, a hormone made by genetic engineering that can increase milk yield by 10-20%.

One of the greatest fears is that absence of guidelines will lead to more trials of GMOs in developing countries. The UNIDO maintains an on-line database of guidelines <gopher://binas.unido.or.at/>, and it includes some Asian countries (guidelines existed in Australia, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore and Thailand in May 1997). There have been several cases of apparent introductions of new organisms without approval. For example, in India there was protest over the release of an undescribed mix of 80 microorganisms in Indian farms that was developed by Japanese researchers, and introduced without informing regulatory authorities that it contained live organisms (Nature 368 (1994), 784).

There are many examples in agriculture of Northern countries using the growing season of the South for further field trials. The USDA exempted a transgenic variety of yellow crookneck squash from review as a GMO in 1994, but some of the seeds for it were made in Thailand, after a September 1992 approval was obtained (Biotechnology 12 (1994), 761-2). Thailand also received applications for GMO release from Israel for the development of a vaccine against avian coliseptisemia; from Belgium for the field evaluation of a new hybrid system in corn; as well as from the United States [Calgene] for the production of virus-resistant cantaloupe, squash and tomato plants.

China has much experience with large releases of GMOs, and has said it will open its biosafety data (Science 266 (1994), 966-7). There is a need for guidelines in developing countries, but debate continues as to how to do this [20]. Scientifically methods for assessing risks have been developed based on ecological principles [21, 22]. A Global Biosafety protocol was discussed in the Jakarta meeting of signatories to the Biodiversity Convention which ended 17 Nov., 1995. The decision was postponed to be made by 1998, and the developing countries wanted to include internal guidelines as well as inter-national movement of GMOs, whereas the EU wanted to only regulate the latter (Nature 377 (1995), 94; 378 (1995), 5). There were 168 signatories to the Convention then, and there is debate over how strict and when a biosafety protocol under article 19 of the convention would be. UNEP has also an alternative plan.

5. Consumer acceptance of novel foodstuffs and global regulation

The success of biotechnology will depend upon the acceptance of products, especially food and medicine. There are many products of genetic engineering and biotechnology approved for medical use around the world. Independent clinical review of drug safety is already standard in most countries, and to be ethical, we must ensure that all people of the world share its protection. Such protection should be standardized, but it is a more difficult question when a country wants to impose stricter standards. A government has a duty to allow beneficial products and technologies to be used by its citizens, including unconventional treatments such as somatic cell gene therapy. This system has also been extended to some new food products.

Another group of products that are made from genetically modified organisms (GMOs) are food additives, such as amino acid supplements. The question is how to examine their safety. In 1990 impure batches of an amino acid L-tryptophan were associated with many cases of a disease, eosiniophilia-myalgia syndrome, which led to 27 deaths in the USA in 1989. The L-tryptophan preparation was produced by Showa Denko, and the cause was insufficient filtering of the preparation, so that one substance was left in the preparation that later was converted to a toxic substance. The substance could have been easily removed by a charcoal filter, but they attempted to save costs. The preparation was made from a genetically modified bacteria, but that was not the cause. Subsequently in the USA, the Food and Drug Administration (FDA) decided to submit L-tryptophan to the testing procedures required for a drug rather than the looser regulations required for a food additive. Not all food additives may need to pass the extra safety tests, but this case must be considered when regulating food additive safety.

Public opinion finds there is more concern about the consumption of products made using genetically modified organisms in Japan than in New Zealand. In all countries surveyed there is less concern about consumption of vegetables than about the consumption of dairy products and meat made from genetically modified organisms [8, 9]. The major issue that is facing regulators and consumers, is how foodstuffs made from varieties of organisms that have been made by genetic engineering should be regulated. New varieties of plants and animals that are used to produce food have been constantly introduced to expand the range of foodstuffs. We can think of kiwifruit, as a stunning example of the rapidity of adoption of a new variety of foodstuff. In general, these foodstuffs are introduced with no safety concern, and in most cases the varieties made using genetic engineering should be harmless, or perhaps even safer than existing foodstuffs. The conclusion of international working groups [23, 24] is that in general there should be no harm to human health and therefore they do not require any special regulations [25]. We are already consuming harmful foodstuffs that have been handed down to us for generations, especially some types of seasoning and spices, and beverages. Compared to the risks from these foodstuffs, the new crop varieties should generally present no significant risk.

Because many of the GMOs destined for food production were first grown extensively in the USA, the decisions of the US FDA have been influential in international policy. The US Food and Drug Administration opposed systematic labeling of foods made from plant biotechnology in 1992. A description of FDA procedures for approval of foods from genetic engineered organisms is Henkel [26]. The FDA exempts food from case by case review unless there are signs that there will be a problem, for example an allergic reaction. This has been criticized by some, especially the decision to leave it up to industry to decide, and also that labels may not be necessary for some products. Some local governments want to regulate, and Chicago passed a local law requiring all foodstuffs made from genetically engineered organisms to be labeled as such (Nature 365: 96). Some companies like Zeneca and Calgene which market tomatoes with delayed softening support the idea of labeling because this removes suspicion from the public mind and gives choice [27].

The UK guidelines on novel foods [28] are implemented through the Ministry of Agriculture, Fisheries and Food, and the Department of Health. Voluntary guidelines have been followed since 1989. Each year a public report is issued including the details of each submission, the arguments discussed, data that was presented, and recommendations made. The Advisory Committee on Novel Foods and Processes (ACNFP) actually also considers food treated in novel ways, not only biotechnology. This is quite consistent with the ethical concerns, because there is no reason to single out one method of food preparation.

Product-based assessment is a theme seen in both the UK and the USA, and in most international reports on the subject. In both countries labeling and review is not statutory, but the choice to do so is often voluntarily made. The UK committee does not recommend labeling if there is no viable genetic material in the final food to be consumed, for example in oils.

There is little work on this in Asia, except for Japan. The Japanese Ministry of Health and Welfare 1992 guidelines for foods and food additives produced by recombinant DNA techniques excluded organisms that have gene deletions from these guidelines, only including organisms which contain "recombinant DNA" sequences or parts of vectors. The "expert committee" of the Ministry will review all cases "to ensure and sustain reasonable criteria", and they can decide whether to insist on additional data from safety tests or not. The data presented must be published in peer reviewed journals.

The Group of Advisors on Ethical Aspects of Biotechnology to the European Commission [29], recommended that food be labeled to indicate when its composition and characteristics have been substantially modified by genetic engineering techniques, but said that labeling was inappropriate when changes are insubstantial. They recommended (article 2.3):

gthe consumers must be provided with information which, for transparency, should be:

* useful, adequate, and informative;

* clear, understandable, non-technical;

* honest, not misleading or confusing, and which aims to prevent fraud;

* enforceable, i.e., possible to verify.h

Basically these labels apply when the product is significantly changed in composition, nutritional value or intended use. Generally they focus on the product rather than the process. European Union Novel Food and Novel Food Ingredient Legislation was passed in 1996 and provided a statutory basis for all EU countries, and food will only be sold in one EU country if no other country objects. There are disputes over labeling requirements, seen in 1996 with the proposals to import soybeans. Because these beans are mixed after farming, it is difficult to know which beans are from GMOs and which are not.

The OECD [30] has had several workshops on the subject of safety of novel foods, and in 1994 held a workshop in Oxford, UK, which used the principle of substantial equivalence, and concluded that the same approach could be applied to microbes, plants and animals. Substantial equivalence suggests that existing organisms used as food, or as a source of food, can be used as a basis for comparison when assessing food safety [31]. They considered three situations:

1) There is substantial equivalence between the new food and a traditional counterpart (e.g. virus resistant plants produced by insertion of the viral coat protein, or herbicide tolerant plants produced by introducing a protein comparable to one already present in a plant but tolerant to a selective herbicide);

2) There is substantial equivalence between the new food and a traditional counterpart, except for the inserted trait (e.g. insect protected plants produced by the insertion of the Bt gene or disease resistant plants produced by the introduction of a new protein); and

3) There is not substantial equivalence between the new food and a traditional counterpart (e.g. introduction of a gene or genes that encode a trait that significantly alters the plant for use in food or feed, such as production of a new oil or carbohydrate).

If substantial equivalence is established they considered that the novel food be treated the same as the familiar one. If there was a new trait, then the evaluation should be case-by-case for the product of the gene. The RNA/DNA toxicity is not an issue, though the potential for transfer is. Some of the factors considered important in evaluation are the source, identity, construction, effect, degree of digestibility, allergenicity, stability of the trait, protein and any products of its action (secondary metabolites), site of expression (tissue specificity) and colonization potential for microorganisms [30]. In the case that a novel food does not have substantial equivalence to a current food, then safety testing was called for.

In conclusion a balance must be found between the right of consumers to information and the imposition of unnecessary information which may confuse people over what are the major facts relevant to their diet, e.g. containing allergens, phenylalanine for sufferers of phenylketonuria, fat content, sugars, etc. Whether the information should be in the form of a label or an information sheet, and what should be in that information (e.g. this product has undergone safety assessment or this product contains X gene), are matters of debate.

Equity demands, that we should ensure that all people of the world enjoy the protection of similarly high safety standards, and that they are kept informed of the content of their food. We may not need to apply any additional regulations to food, unless novel components are introduced to the food. The policy has recently been formulated in several countries. In a rapidly moving and new area, an independent committee approach to regulation is the only way to efficiently and safely examine food safety.

The key question is whether they decide the foods are novel or not, because if they are novel, extensive safety tests must be performed. International food safety and environmental standards should be speedily developed to ensure that all people of the world share their protection, and no country becomes a testing ground for new applications. Human rights need to be increasingly respected so that we get social progress in addition to scientific progress. All people should equally share both the benefits of new technology and the risks of its development.

6. Economics, and patenting of genetic resources

All people should share in the benefits of biotechnology. There is ethical and religious support for this, such as "love thy neighbour as thyself", and the utilitarian ideal that we should try to benefit as many people as possible, and from the ethical/legal principle of justice. In the United Nations Declaration of Human Rights, Article 27(1), is a basic commitment that many countries in the world have agreed to observe. These are (1) Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits (italics added for emphasis). The common claims to share in the benefits of technology should be considered in all aspects of biotechnology, also including the questions of who should make decisions concerning its applications. This question is important for the sharing of technology, and also in the discussion about the ethical issues regarding intellectual property discussed below.

Much of the new wave in biotechnology research is being performed by private companies. These companies are being encouraged to perform research in their countries' national interests, including the hope of more export earnings from the sale of products and/or technology. Research has for many decades also been viewed in terms of the business opportunities, both internationally and within nations. Many people believe that the pursuit of knowledge itself is a good, though increasingly the pursuit of beneficial knowledge is viewed as more important. Another important argument people give to promote research is that of national economy and pride. This can be converted to political benefit, if countries are seen to provide much international development assistance.

Research facilities include universities, government and private research institutes, and hospitals. The funding sources in different countries come from government, charity or industry. In Japan approximately 19% of scientific research and development funding is from the government, whereas the proportions for some other countries are: Australia (50%), England (37%), France (48%), Germany (33%), Netherlands (42%), New Zealand (63%), USA (48%). In the USA about 7% of the total government spending is on research and development, but in Japan it is only about 3%, while Western European governments spend 4-5% of their budget on research and development [32].

It is obvious that the goals of private companies are not those of whole countries. Many Western biotechnology companies are of very small size, but multinational corporations have been gaining increasing control of biotechnology research, because of the long period of research required before any profits are made [7], and also many patent claims are contested in lengthy court battles with inconsistent rulings in different countries. In Japan, government ministries and large multinationals have been the major investors in biotechnology from the early 1980's, because of more difficulty in establishing small companies than in the USA. Internationally, there will be more competition between different multinational companies than countries.

Industrialized countries have been gathering seeds and genetic resources from other countries for centuries, for the development of new crops and products [33]. In 1982, the OECD estimated that the contribution of developing countries to just the major crops in the USA could be economically valued at several billion dollars annually. In 1993 the Biological Diversity Convention was ratified. Developing countries do possess such resources, but want to minimize the loss of control over them, and preserve them. Genes are raw materials for biotechnology, and there is not always free access to genetic material. Internationally, there is a network of gene banks, and some do provide free access to the materials stored. In 1991, the company Merck & Co., made an agreement with Costa Rica for conservation in exchange for exclusive rights to new potential "products" it finds in an area of its tropical forests until the year 2000. It is like a hunting license for useful compounds. If successful, a share of the profits will be paid to Costa Rica, while the company benefits from the new substances found.

One of the social issues is whether applications should attempt to preserve rural structure. In developing countries like India, the agricultural sector employs over 80% of the active population, but in industrialized countries only 5-10%. Some crops are labour intensive, and others are not, for example, oil palm plantations require about one third of the labour required in banana plantations. What seems like a benefit, to reduce farm labour by using herbicide tolerant crops instead of weeding, will actually lead to loss of work for many people, especially women, and further poverty. Other traits will have benefit, such as pest-resistant plants which will not require pesticide application. Also year round crop production made possible by breeding climate resistant varieties, may increase labour, as the geographical areas into which such plants can be grown are extended. The effects depend on the country, for example the use of bovine growth hormone to increase milk production in dairy cows is opposed by many groups in Western countries because it may favour larger farms, but in some developing countries, such as Mexico or Pakistan, its use was warmly welcomed because it reduces imports of milk powder.

Nevertheless, there are many definite benefits for all countries from biotechnology, which should direct research attention to these ends. Most will be guaranteed a stable internal food supply. In 1996 new crops that are GMOs comprised 1% of the total US soybean crop, and in 1997 ten times that level were expected. There are other uses, for example, a benefit for some developing countries may be the development of fast growing biomass, that could be used as a fuel source to reduce the need for oil imports. In addition to the obvious environmental benefits, it would also lessen dependence on imported oil and gas as a source of energy.

The question of patenting live organisms and genetic material is a contentious issue. In the USA and many other countries, normal criteria for accepting patents apply to any subject matter, that is, the invention requires the attributes of novelty, non-obviousness, and utility, and the invention should be deposited in a recognized depository. In 1985 the US Patent Office awarded a patent for a maize variety, in 1987 they ruled that polyploid oysters were patentable subject matter, and in 1988 they awarded a patent for a mouse [34, 35]. The mouse contains an activated oncogene and was called "oncomouse". It is very sensitive to carcinogens, and is being used in testing the safety of substances. The patent extends to all transgenic animals containing an activated oncogene. This patent decision triggered much debate about the ethical issues over patenting.

While accepting the same patentability criteria, some countries have specifically excluded certain types of invention, for example the European Patent Convention excludes the patenting of varieties of plants or animals. In 1989 the European Patent Office rejected the patent application for "Oncomouse", but in October 1991 they reversed this decision, and approved it [36]. A 1988 EC draft directive supporting the principle of patents for genetically engineered animals, was debated for 6-7 years before being rejected. There is public rejection of the idea of patenting animals in some countries, and Denmark excludes animal patents in a law. Japan has granted some patents on animals and plants, and has an additional "Seeds and Seedlings Law" by which intellectual property rights can be granted to plants. It is unclear how the GATT rules will be implemented.

Methods for gene sequencing, or mapping, or expression, can be invented and patented. The direct use of proteins as therapy is well established, and these products may be patented [37], though we should note, in general, medical procedures have not been patented for ethical and practical reasons. The system is self-sustaining, as there is less incentive for companies to conduct research if they cannot obtain patent protection to allow them exclusive marketting of the product for some period before generic products (copies) can be marketted. There may be a greater amount of total knowledge because there is more total research performed. However, property rights are not absolutely protected in any society because of the principle of justice, for the sake of "public interest", "social need", and "public utility", societies can confiscate property. There are also exemptions to patent law if the object is "offensive to (general) public morality", which could prevent the patenting of some animals.

Some of the reasons against extending patents to plants and animals include: lack of evidence that patents do stimulate invention, distinction between discovery and invention, need to allow access to the organisms, extended protection, the ideas of biotechnology were developed in the public, no special reason to privatize public goods, need for uniform utility patents, and inequality among the different countries in access [38, 39]. New medicines may still be developed without patenting animals.

The human genome is common property of all human beings, and no one should be able to patent it beyond specific uses of genes [40]. There is public rejection of the patenting of genetic material from humans, and there are also many who reject patenting of genetic material from plants and animals. This is seen in the results of the International Bioethics Survey shown in Table 1 [9]. In the 1991 Japanese study [8], there was more acceptance of the patenting of genetic material among those who thought there were benefits to their countries from genetic engineering, and by scientists in Japan. There was significantly more acceptance of patenting of all subject matter (except books) by company scientists compared to university and government scientists (Table 2).

There may be better alternatives to patenting plants and animals such as the UPOV Convention which established international "plant variety rights". By 1989 there were 19 member countries, which include more than 70% of the world seed market of all countries with a market economy[41]. The requirements include stability, homogeneity, novelty, and distinctiveness. The varieties must be generally distributed and researchers have exemptions, as do farmers from the payment of royalties on seed that they save from their harvest.

However, there is still no reward given to the farmers who for millennia have established crop varieties, which plant breeders use as starting materials. It is ironic that small farmers continue to lose their farms in the development of commercial biotechnology. In 1983, at a UN Food and Agriculture Organization conference, representatives from 156 countries recognized that "plant resources were part of the common heritage of mankind and should be respected without any restriction". Since then an international network of gene banks has begun to be established, which provide genetic material worldwide. There is also a FAO Standing Commission on Plant Genetic Resources. These also preserve genetic material from species that are becoming extinct because of environmental destruction.

In 1996, world parliamentarians called for a ban on the patenting of human genes and a clarification of rules governing biomedical research. Politicians from 114 national parliaments, meeting in Madrid, approved a resolution on bioethics on 1st April, the final day of the biannual Inter-Parliamentary Union (IPU) conference. The resolution stressed ''the urgent need to ban the patenting of human genes...(and) prohibit all financial gain from the human body or parts thereof, subject to exceptions provided for by law.'' The IPU, wary of a threat to fundamental human rights from advances in medical science, called on national parliaments to define a common legal framework within which rules on genetic research could be established.

Some equity issues have been highlighted in the media. An indigenous Indian tribe was awarded intellectual property rights to the drug jeevani, from the plant Trichopus zeynicus, called Indian ginseng, (Nature 381 (1996), 182). India is challenging the US patent on the use of turmeric to heal wounds, (Nature 382 (1996), 106). Scientific research in India was done in 1953, although US researchers claimed a patent recently! It was known much longer as a traditional medicine, raising general issues. The patenting of a neem tree extract azadirachtin by W.R. Grace ltd. is another example. Population genetics researchers have sometimes collected samples which have led to attempts to patent cells or DNA. After several years of controversy, the US NIH has renounced all rights to US patent 5,397,696 which covers white blood cell lines from a Hagahai tribesman in Papua New Guinea (Official Gazette of US Patent and Trademark Office, 10 Dec. 1996; Nature 384 (1996), 500).

7. The future challenges

In this paper some of the bioethical issues especially risk and equity have been discussed. Another issue of ethics is who should make decisions, and who do people trust. Surveys reveal differences between countries in who is most trusted as a source of information about biotechnology [9, 42]. There was most trust in the government in Hong Kong and Singapore, and least in Australasia, Japan, Russia, USA and Europe. Despite the lower trust shown in the government in Russia, they had a level of trust in medical doctors. Companies were least trusted everywhere. Farmers were also not trusted except in the USA.

Decision-making in most Asian countries tends to exclude the public, and biotechnology is no exception. However, biotechnology has led to more public debate then many other issues in the past. In some democracies the public has a clear role in the process of regulation, and clear opportunities to voice concerns. This opportunity to voice concerns is important to gain public trust, especially considering the lack of trust. In some countries hearings are conducted in public, as in the NIH RAC committee hearings on human gene therapy in the USA. The survey responses show that the public can make well reasoned arguments concerning biotechnology risk and benefit. The public should be involved more in committees making science policy and regulating applications of science. This requires more public willingness to be involved, and the scientists and bureaucrats should allow third party and public entry to committees. As a minimum standard for ensuring ethical biotechnology, decisions should be made in forums open to public knowledge.

On the other hand, bureaucracy is a challenge for the progress of science demanded by the principle of beneficence. In 1997 researchers in South Korea announced that they had conducted a gene therapy clinical trial for the first time, although the country did not have guidelines at the time [43]. The project had been reviewed by two committees in Korea, and the US FDA, and may be supported by public opinion. However, if the media reported it in a negative way it could be seen as scientists being too eager to wait for regulations to be drafted, and could weaken trust in public authorities. Expectations of the public for debate vary between country, but given the global media we could see people expecting to be involved in every country.

There is a significant public policy decision to be made regarding public education programs. There has been an information campaign underway for a decade in Japan supported by members of the Japan Bioindustry Association, involving government and industry, to promote biotechnology. It appears to have resulted in high awareness of biotechnology, with mixed perceptions. There are also calls in Europe by industry groups to promote biotechnology, with the goal of reducing what is seen as a high level of concern about the technology. Such campaigns can include publication of books, which can also be useful to promote discussion of ethical issues. Some US companies also have large public relations campaigns, such as Monsanto. However, rather than attempting to dismiss feelings of concern, society should value and debate these concerns to improve the bioethical maturity of society. However, media responsibility is crucial.

Attempts to develop international bioethical approaches must involve consideration of the values of all peoples. We could call this cross-cultural bioethics. This means something different from universalism - attempts to define an international ethical code of what is ethical and what is not, or a table of acceptable and unacceptable risks based on consideration of ethical principles. We see difficulty in universal recognition of basic laws such as those respecting human rights. However, the existence of international environmental laws, e.g. The Law of the Sea, and charters of human rights is some encouragement for the future progress of limited universalism. We also see attempts within regions, such as by the Council of Europe, to devise the European Convention on Bioethics which was agreed upon and signed by over 20 countries in April, 1997. The UNESCO Declaration on the Human Genome and Protection of Human Rights was adopted by all countries of UNESCO in November 1997.

Cross-cultural bioethics involves mutual understanding of various cultural, religious, political and individual views that people have. The diversity of individual viewpoints in any one culture appears to exceed the differences between any two. People in many countries do share the same hopes and fears which strengthens the call for international standards. What we call "ethical biotechnology" cannot be decided just by public opinion. However, something which is morally offensive to the majority of people in a country, or region, or world-wide, is judged to be immoral and is likely to be outlawed [44].

There are implications of public understanding of biotechnology for policy in technology assessment, education and information campaigns, and where and what decisions are taken. Scientists, industry, and government have special responsibilities in the ethical application of biotechnology, consistent with the goals of society and together with the media in providing understandable information to the public consistent with the goals of society.

References

1. Macer, Darryl R.J. (1990) Shaping Genes: Ethics, Law and Science of Using Genetic Technology in Medicine and Agriculture. Christchurch: Eubios Ethics Institute 1990.

2. Macer, D.R.J. (1996) "Biotechnology, International Competition, and its economic, ethical and social implications in developing countries", pp.378-397 in Concepts in Biotechnology, Ed. Balasubramanian, D. et al. India: Universities Press Pvt. Ltd, Orient LongMan Inc.

3. Walgate, R. (1990), Miracle or Menace? Biotechnology and the Third World. London: Panos Institute.

4. see references cited in reference 1.

5. BIDEC (1986) Impact of Biotechnology on Industrial Structure in the Year 2000. Tokyo: Japanese Fermentation Association (in Japanese).

6. Schmid, Rolf D. (1991)Biotechnology in Japan. A Comprehensive Guide Berlin: Springer-Verlag.

7. OTA, U.S. Congress Office of Technology Assessment. (1991) Biotechnology in a Global Economy (Washington: U.S.G.P.O., OTA-BA-494.

8. Macer, D.R.J. (1992), Attitudes to Genetic Engineering: Japanese and International Comparisons. Christchurch: Eubios Ethics Institute.

9. Macer, D.R.J. (1994) Bioethics for the People by the People. Christchurch: Eubios Ethics Institute.

10. MHW, Ministry of Heath and Welfare. (1992) Guidelines for Foods and Food Additives Produced by Recombinant DNA Techniques. Tokyo: Chuou Houki, Shuppann.

11. OTA, U.S. Congress Office of Technology Assessment. (1988) New Developments in Biotechnology, 3: Field Testing Engineered Organism, Genetic and Ecological Issues Washington: U.S.G.P.O., OTA-BA-350.

12. OTA, U.S. Congress, Office of Technology Assessment. (1987) New Developments in Biotechnology, 2: Public Perceptions of Biotechnology - Background Paper (OTA-BP-BA-350, Washington D.C.: U.S.G.P.O.

13. Hoban, T. J. & Kendall, P.A. (1992) Consumer Attitudes About the Use of Biotechnology in Agriculture and Food Production. Raleigh, N.C. North Carolina State University.

14. Hamstra, A.M. (1992) "Consumer research on biotechnology", pp. 42-51 in Biotechnology in Public, J. Durant, ed., Science Museum, London.

15. Hamstra, A.M. (1993) Consumer Acceptance of Food Biotechnology SWOKA Report 137, Institute for Consumer Research, Koningin Emmakade 192-195, 2518 JP 's-Gravenhage, The Netherlands.

16. Martin and Tait, J. (1992) in Biotechnology in Public, J. Durant, ed., Science Museum, London.

17. Couchman, Paul K. & Fink-Jensen, Kenneth. (1990) Public Attitudes to Genetic Engineering in New Zealand, DSIR Crop Research Report 138. Christchurch: DSIR.

18. Zhang, Z. (1991) "People and science: public attitudes in China toward science and technology", Science and Public Policy 18, 311-7.

19. Eurobarometer Surveys organised by European Commission.

20. Miller, H.I. et al. (1995) "An algorithm for the oversight of field trials in economically developing countries", Biotechnology 13, 955-9.

21. Tiedje, J.M. et al. (1989) "The planned introduction of genetically engineered organisms: ecological considerations and recommendations," Ecology 70: 298-315.

22. Macer, Darryl (1996) "Public acceptance and risks of biotechnology", pp. 227-245 in Coping with Deliberate Release: The Limits of Risk Assesment, Ed. A. van Dommelen (Tilburg, The Netherlands: International Centre for Human and Public Affairs.

23. IFBC (1990) International Food Biotechnology Council, Biotechnologies and Food: Assuring the safety of foods produced by genetic modification, (Washington D.C.: IFBC May.

24. WHO (1991) Report of a joint FAO/WHO Consultation, Strategies for assessing the safety of foods produced by biotechnology Geneva: WHO.

25. Macer, Darryl (1997) Bioethics, food and plant biotechnology, in Proceedings of the 4th Session of UNESCO International Bioethics Committee (Paris: UNESCO.

26. Henkel, J. (1995) Genetic engineering. Fast forwarding to future foods, FDA Consumer (April 1995), 6-11.

27. Butler D. (1995) Phanel offers compromise on food labellingh. Nature 375, 443.

28. Jonas DA, (1995) The UK approach to the regulation and evaluation of novel foods produced by biotechnology. Archives of Toxicology Supplement 17, 557-61.

29. European Commission Group of Advisors on the Ethical Implications of Biotechnology (1996). Ethical aspects of the labelling of foods derived from modern biotechnology. 5 May 1995. Reproduced in Politics and the Life Sciences 14, 117-9.

30. OECD, Organisation for Economic Co-operation and Development. (1996) Food Safety Evaluation. Paris: OECD.

31. OECD, Organisation for Economic Co-operation and Development. (1993)Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles. Paris: OECD.

32. OECD, Organisation for Economic Co-operation and Development, Science Indicators.

33. Juma, Calestros (1989)The Gene Hunters. Biotechnology and the Scramble for Seeds Princeton University Press.

34. Lesser, William H. (ed.) (1989)Animal Patents: The Legal, Economic and Social Issues New York: Stockton.

35. OTA, U.S. Congress Office of Technology Assessment (1989), New Developments in Biotechnology, 4: Patenting Life Washington: U.S.G.P.O., OTA-BA-370.

36. Aldhous, P. (1991) Nature 353: 589.

37. Thomas, SM. et al. (1996) "Ownership of the human genome", Nature 380, 387-8.

38. For a discussion see references 1, 35, 39, for example.

39. Busch, L.(1995) gEight reasons why patents should not be extended to plants and animals", Biotechnology and Development Monitor 24, 24.

40. Macer, DRJ. (1991). gWhose genome project?h Bioethics 5, 183-211.

41. Lesser, William H. (1991) Equitable Patent Protection in the Developing World: Issues and Approaches. Christchurch: Eubios Ethics Institute.

42. Rothenburg, L. & Macer, D. (Sept. 1995) gPublic acceptance of food biotechnology in the USA.h Biotechnology & Development Monitor 24, 10-3.

43. Swinbanks, D. (1997) gKorea leaps before it looks over gene therapy guidelines.h Nature 387, 6.

44. Macer, Darryl R.J. (1995) "Bioethics and biotechnology: What is ethical biotechnology?", pp.115-154 in Modern Biotechnology: Legal, Economic and Social Dimensions, Biotechnology, Volume 12, ed. D. Brauer. Weinheim, Germany: VCH.

Table 1: Support for patenting of different subject matter in the 1993 International Bioethics Survey

Q. People who create something original can obtain financial reward for their efforts through patents and copyright. In your opinion, for which of the following should people be able to obtain patents and copyright? 1 Approve 2 Disapprove 3 Don't know

%

Public

Students

NZ

A

J

India

Thai

R

Israel

NZ

A

J

India

Thai

P

S

HK

New Inventions, such as consumer products

Yes

90

93

85

79

78

52

76

93

90

92

72

75

89

76

65

No

4

2

6

12

9

15

10

2

3

2

15

14

6

9

15

DK

6

5

9

9

13

33

14

5

7

6

13

11

5

15

20

Books and other information

Yes

82

80

68

74

69

77

76

88

88

82

68

65

88

64

62

No

8

8

14

16

17

6

14

6

5

7

18

16

8

17

14

DK

10

12

18

10

14

17

10

6

7

11

14

19

4

19

24

New plant varieties

Yes

63

55

49

60

85

59

64

56

49

52

61

83

65

66

47

No

22

24

19

21

8

12

22

26

33

19

23

10

26

17

31

DK

15

21

32

19

7

29

14

18

18

29

16

7

9

17

22

New animal breeds

Yes

48

45

41

54

82

54

58

50

39

45

59

78

61

56

42

No

33

29

26

25

10

16

24

32

37

24

28

12

29

26

28

DK

19

26

33

21

8

30

18

18

24

31

13

10

10

18

30

Genetic material extracted from plants and animals

Yes

31

38

35

50

73

52

56

33

32

30

51

78

52

55

40

No

41

34

30

25

12

13

28

41

39

39

27

11

36

21

29

DK

28

28

35

25

15

35

16

26

29

31

22

11

12

24

31

Genetic material extracted from humans

Yes

23

31

32

42

60

45

46

22

28

25

46

70

44

47

37

No

50

43

36

34

18

17

36

57

46

48

31

17

44

26

30

DK

27

26

32

24

22

38

18

21

26

27

23

13

12

27

33

A medical treatment or drug to cure AIDS

Yes

59

60

60

66

81

94

62

43

54

56

71

83

74

73

60

No

28

26

21

22

13

3

28

40

34

26

18

13

19

20

22

DK

13

14

19

12

6

3

10

17

12

18

11

4

7

7

18

Country abbreviations: NZ New Zealand; A Australia; J Japan; Thai Thailand; R Russia; P Philippines; S Singapore; HK Hong Kong.


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