Biotechnology and Bioethics: What is Ethical Biotechnology?

pp.115-154 in Modern Biotechnology: Legal, Economic and Social Dimensions, Biotechnology, Volume 12, ed. D. Brauer (Weinheim, Germany: VCH, 1995).
Author: Darryl R. J. Macer


Table of Contents

1 Biotechnology and Bioethics
2 Bioethics
2.1 Autonomy
2.2 Rights
2.3 Beneficence
2.4 Do no harm
2.5 Justice
2.6 Confidentiality
2.7 Animal rights
2.8 Environmental ethics
2.9 Decision-making
3 Cross-cultural bioethics
4 Perceptions of ethical biotechnology
4.1 "Moral" is not the same as ethical
4.2 Mixed perception of benefit and risk
4.3 Reasoning behind acceptance or rejection of genetic manipulation
5 Past and present "bioethical conflicts" in biotechnology
5.1 Interference with nature or "playing God"
5.2 Fear of unknown
5.2.1 Unknown health concerns
5.2.2 Environmental and ecological risks
5.3 Regulatory concerns
5.4 Human misuse
6 Future "bioethical conflicts" in biotechnology
6.1 Changing perceptions of nature
6.2 Pursuit of perfection - a social goal
6.3 Limitation of individual autonomy
6.4 Human genetic engineering
7 Bioethics versus business: a conflict?
7.1 Intellectual Property Protection
7.2 Global issues of technology transfer
7.3 Short-term versus long-term perspectives
7.4 Safety versus Costs
7.5 Is new technology better?
8 Resolution of conflicts
8.1 Who can be trusted?
8.2 Provision of information may obtain higher public approval
8.3 Public education not propaganda
8.4 Sufficient regulations
8.4.1 Regulation of environmental risk
8.4.2 Food safety
8.5 Public involvement in regulatory processes
9 Ethical limits of biotechnology
9.1 Absolute or relative?
9.2 Timeless or transient?
9.3 Scientific responsibility for ethical applications
10. Criteria to assess whether biotechnology research is ethical
11 Conclusion
12 References


1 Biotechnology and Bioethics

As has been described in other volumes of this series, modern biotechnology has had a great impact on medicine and agriculture. It can only be expected to have an even more dominating impact in future science and technology. It's impact is not limited to the technical impact that these advances have upon industry, medicine and agriculture, any technology influences society, and one can expect that life science technology potentially has the greatest impact.

Biotechnology has also influenced the thinking of society, as will be discussed in this chapter, and we can expect further paradigm shifts to occur. These 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 (Macer, 1990), and the two words, biotechnology and bioethics, have coevolved.

Before extending discussion it is essential to define what is meant by the words, biotechnology and bioethics. This in itself is no easy task because different people with different interests can broaden or narrow these concepts. In this chapter a broad meaning of biotechnology is taken; the use or development of techniques using organisms (or parts of organisms) to provide or improve goods or services. Bioethics is the study of ethical issues associated with life, including medical and environmental ethics.

2 Bioethics

There are large and small problems in ethics; there are global, regional, national, community and individual issues. We can think of ethical issues raised by biotechnology that involve the whole world, and issues which involve a single person. A global problem such as global warming may be aided by global applications of biotechnology, for example to reduce net atmospheric carbon dioxide increase by reducing emissions or increasing biomass, however, excess consumption and energy use can only be solved by individual action, to reduce energy use. A regional issue is the risk presented by the introduction of new organisms or of an unstable genetically modified organism (GMO) into the environment, but it also involves individual responsibility to ensure that sufficient care and monitoring of the release is made. Other ethical issues arising from biotechnology that are thought of as individual issues such as genetic testing, or use of gene therapy, also have societal implications.

We hardly need to ask why we need ethics, rather we need to ask what principles and factors are crucial for guiding decision-making, especially over such a diverse spectrum of issues. Medical ethics involves decision making on a personal level, it concerns the patient and the health care professional, especially the physician. At a further level away may be many others who will be indirectly affected by such questions as the cost of very expensive treatment that takes funds away from other patients. At this level higher policy-making is required, as in the case of issues such as environmental risk, or intellectual property protection policy.

Some key principles of ethics are outlined below, with brief discussion of their relevance to biotechnology issues. We should balance the implications that arise from each principle to arrive at more ethical decisions. We may need to develop further principles, and bioethics is still being developed (Macer, 1990a).

2.1 Autonomy

All people are different. This is easy to see, if we look at our faces, sizes and the clothes that we chose to wear. This is also true of the choices that we make. We may decide to play tennis, or golf, or chess, read a book, or watch television. These are all personal choices. In a democratic society we recognise that we have a duty to let people make their own choices. Above the challenges of new technologies, and increasing knowledge, the challenge of respecting people as equal persons with their own set of values is a challenge for all. This is also expressed in the language of rights, by recognising the right of individuals to make choices.

2.2 Rights

Legal rights are claims that would be currently backed by the law if the case went to court, while human rights are critical to maintaining human dignity but may not have yet attained legal recognition. The recognition of human rights has changed the situation in many countries, and many countries in the world have signed the U.N. Declaration of Human Rights (Sieghart, 1985), or one of the regional versions of this. This can be applied to many situations, for example, we all have a right to be involved in decisions about our country, the freedom of religion, or speech, to raise a family, to share in the benefits arising from scientific advances, and a right to a reasonable future. Respect for personal rights should change the nature of relationships between people in power and people without power from being characterised by authoritarianism or paternalism to becoming a partnership.

Ethics is not the same as law. Ethics is a higher pursuit, doing more than the law requires. The law is needed to protect people and to set a minimum standard, but you can not determine good moral behaviour by settling cases in a court of law. We only need to think of medical litigation or environmental damage penalties, which can lead to huge sums of money being paid for accidents (or negligence) which cannot really be compensated by monetary reimbursement. The solution is to have more careful and moral physicians, companies, and politicians, and the replacement of monetary balance sheets by ethical values, as the primary motive of decision-making.

2.3. Beneficence

One of the underlying philosophical ideas of society is to pursue progress. The most cited justification for this is the pursuit of improved medicines and health. It has often been assumed that it is better to attempt to do good than to try not to do harm. A failure to attempt to do good, working for people's best interests, is taken to be a sin of omission. Beneficence is the impetus for further research into ways of improving health and agriculture, and for protecting the environment. Beneficence supports the concept of experimentation, if it is performed to lead to possible benefits.

The term beneficence suggests more than actions of mercy, for which charity would be a better term. The principle of beneficence asserts an obligation to help others further their important and legitimate interests. It means that if you see someone drowning, providing you can swim, you have to try to help them by jumping in the water with them. It also includes the weighing of risks, to avoid doing harm.

Governments have a duty to offer their citizens the opportunity to use new technology, providing it does not violate other fundamental ethical principles. Just what the definition of fundamental ethical principles are may be culturally and religiously dependent, especially in the way that they are balanced when opposing principles conflict (see Sec. 3). Although different cultures vary, they all share some concept of beneficence and do no harm. People should be offered the option of using new technology in medicine and agriculture, and such applications should be made, providing internationally accepted ethical and safety standards are applied.

Beneficence also asserts an obligation upon those who possess life-saving technology, in medicine or agriculture, to share their technology with others who need it. This is relevant to biotechnology companies also, who may hold patent rights on particular processes, beneficence would assert that they must share it with others, even if they cannot pay for it. This may mean that companies share developments with developing countries, or give new drugs to individuals too poor to purchase them.

2.4 Do no harm

The laws of society generally attempt to penalise people who do harm, even if the motive was to do good. There needs to be a balance between these two principles and it is very relevant to areas of science and technology, where we can expect both benefits and risks. Importantly, we must balance risks versus benefits of different and often alternative technologies, then apply these comparisons to our own behaviour, as well as in determining government policy.

Do no harm is a very broad term, but is the basis for the principles of justice and confidentiality, and philantropy. It can also be expressed as respect for human life and integrity. This feature is found in the Hippocratic tradition and all other traditions of medical and general ethics. To do no harm is expressed more at an individual level, whereas justice is the expression of this concept at a societal level. Do no harm has been called the principle of nonmaleficence.

Biotechnology and genetic engineering are providing many benefits, but there are also many risks. It is also unclear who will really benefit the most. 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 (Walgate, 1990). All people of the world can benefit if it is used well, through medicines, and more environmentally sustainable agriculture. However, biotechnological inventions that allow industrialised countries to become self-sufficient in many products will change the international trade balances and prosperity of people in developing and industrialised 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 enzymic conversion of corn starch into high fructose corn syrup causes serious damage to the economies of sugar exporting nations (Sasson, 1988), and may already have caused political instability there. We need to remember national and international issues.

Although we will continue to enjoy the many benefits to humanity, and we may hope for environmental benefits, the price of the new technology is that it may make us think about our decisions more than in the past. This is long overdue!

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.

2.5 Justice

Those who claim that individual autonomy comes above societal interests need to remember that the reason for protecting society is because it involves many human lives, which must all be respected. Individual freedom is limited by respect for the autonomy of all other individuals in society and the world. People's well-being should be promoted, and their values and choices respected, but equally, which places limits on the pursuit of individual autonomy. We also need to consider interests of future generations which places limits on this generation's autonomy. We also need to apply this principle globally, as discussed above, no single country should pursue policies which harm people of any country.

The key principle arising from the high value of human life is respect for autonomy of each individual human being. This means they should have the freedom to decide major issues regarding their life, and is behind the idea of human rights. This idea is found in many religions also. Part of autonomy is some freedom to decide what to do, as long as it does not harm others, also called individual liberty or privacy. Well-being includes the principle of "do no harm" to people, and to work for people's best interests.

Internationally, the area of biotechnology patent policy should be examined in light of public opinion and the principle of justice. Shared genetic resources should not be able to be owned by any one individual or company. At the same time, some patent protection for specific applications involving biotechnology need to be protected to encourage further research, and to make the results of such research immediately open for further scientific research (see Sec. 7).

2.6 Confidentiality

The emphasis on confidentiality is very important. Personal information should be private. There may be some exceptions when criminal activity is involved or when third parties are at direct risk of avoidable harm. It is very difficult to develop good criteria for exceptions, and they will remain rare. We must be careful when using computer databanks that contain personal information, and if they can not be kept confidential, the information should not be entered to such a bank.

A feature of the ethical use of new genetics is the privacy of genetic information. This is one of the residual features of the existing medical tradition that needs to be reinforced. It is not only because of respect for people's autonomy, but it is also needed to retain trust with people. If we break a person's confidences, then we can not be trusted. If medical insurance companies try to take only low risk clients by prescreening the applicants, there should be the right to refuse such questions (Holtzman, 1989). The only way to ensure proper and just health care is to enforce this on employers and insurance companies, or what is a better solution, a national health care system allowing all access to free and equal medical treatment. We need to protect individuals from discrimination that may come in an imperfect world, one that does not hold justice as its pinnacle.

2.7 Animal Rights

These above principles apply to human interactions with other humans. However, we also interact with animals, and the environment.

The moral status of animals, and decisions about whether it is ethical for humans to use them, depends on several key internal attributes of animals; the ability to think, the ability to be aware of family members, the ability to feel pain (at different levels), and the state of being alive. All will recognise, inflicting pain is bad so if we do use animals we should avoid pain (Singer, 1976). If we believe that we evolved from animals we should think that some of the attributes that we believe humans have, which confer moral value on humans, may also be present in some animals (Rachels, 1990). Although we cannot draw black and white lines, we could say that because some primates or whales and dolphins appear to possess similar brain features, similar family behaviour and grief over the loss of family members to humans, they possess higher moral status than animals that do not exhibit these. Therefore, if we can achieve the same end by using animals that are more "primitive" than these, such as other mammals, or animals more primitive than mammals, then we should use the animals at the lowest evolutionary level suitable for such an experiment, or for food production (which is by far the greatest use of animals). If we take this line of reasoning further, we conclude that we should use animal cells rather than whole animals, or use plants or microorganisms for experiments, or for testing the safety of food.

Animals are being used for genetic engineering, for use as models of human disease, for use in the production of useful substances such as proteins for medical use, and in the more traditional uses in agriculture. Some of these uses, such as the production of mutations in strains of animal to study human disease will have human benefit, but are more ethically challenging because some of these strains may feel pain (Macer, 1989, 1991a).

2.8 Environmental Ethics

Humans also have interactions with the environment, and in fact depend upon the health of the environment for life. The easiest way to argue for the protection of the environment is to appeal to the human dependence upon it. There are also human benefits that come from products we find in nature, from a variety of species we obtain food, clothing, housing, fuel and medicine. The variety of uses also supports the preservation of the diversity of living organisms, biodiversity. As we have learnt, the ecosystem is delicately balanced, and the danger of introducing new organisms into the environment if that may upset this balance is another key issue raised by genetic engineering. However, we have been using agricultural selection for 10,000 years, so the introduction and selection of improved and useful microorganisms, plants and animals is nothing new, and we should learn from mistakes of the past.

The above arguments should convince people of the value of the environment, and that is a first stage. However, it appeals to our sense of values based on human utility. There is a further way to argue for the protection of nature and the environment, and it is a more worthy paradigm. It is that nature has value for itself because, it is there. We should not damage other species, unless it is absolutely necessary for the survival of human beings (not the luxury of human life). Nature has life, thus it has some value. Another paradigm for looking at the world is a religious view, that God made the world so the world has value, and we are stewards of the planet, not owners. This paradigm can make people live in a better way than if they look at the world only with the paradigm of human benefit.

There needs to be examination of the view of nature that different people have, so that we can find what the commonly acceptable limits to modification of nature, plant and animal varieties, and human beings are. In the modern world any new science can easily spread, so researchers are accountable to all peoples of the world. There will be future possible applications of technology which are against "common morality", yet there is little research on what is acceptable. We need to know what these perceived limits of changing nature are, before we grossly change the characters of individual organisms, or make irreversible changes to the ecosystem and human society. On Eco-philosophy, see Chapter 11.

Microorganisms are generally placed at the lowest end of the "scale" of ethical status, because the only internal character they have is the state of being alive. External factors from a human aesthetic viewpoint mean that the only argument usually applied to them is human utility.

Biodiversity may have some value in itself, though it is yet to be defined in non-religious terms. If we want to preserve biodiversity, it is essential that we separate parts of nature on land and ocean as nature reserves or parks, away from the parts of nature which are agricultural areas. However, while we separate these areas physically we should not separate them psychologically as areas which we can abuse and areas which we protect. This applies both in terms of sustainable environmental protection and animal rights. In fact, agricultural biodiversity is of direct human utility, and we should attempt to stop its continued loss (Fowler and Mooney, 1990).

2.9 Decision-making

To anyone who starts to try to apply these principles in their daily life or to decisions concerning biotechnology, it will very soon be apparent that there needs to be a balancing of conflicting principles of ethics. Different interests will conflict, so, for example, there are exceptions to the maintenance of privacy and confidentiality if many people or large environmental damage, are threatened. How do we balance protecting one person's autonomy with the principle of justice, that is protecting all people's autonomy. Many medical and scientific procedures are challenging because they involve technology with which both benefits and risks are associated, and will always be associated.

Human beings are challenged to make ethical decisions, and to balance the benefits and risks of alternatives, they have to. The benefits are great, but there are many possible risks. In this regard utilitarianism, that we should attempt to produce the most happiness and benefit, will always have some place, though it is very difficult to assign values to different interests and to the degree of "happiness" or "harm". Although our life may become easier due to technological advances, so that it may appear that we don't need to make so many decisions, we are challenged to make more decisions than in the past. The more possibilities that we have, the more decisions that we make (Macer, 1990).

Standards of education are increasing, but it is another thing whether people are educated for decision-making. People need to be taught more about how to make decisions, and the education system should accommodate this need of modern life. Even if they are, this may still be no guarantee that the right decisions will be made.

3 Cross-Cultural Bioethics

Any attempt 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.

Universalism is not currently possible in ethics, and we even have 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 (Sieghart, 1985), 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 a European Convention on Bioethics (EP, 1991, Mundell, 1992, Holm, 1992).

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. For example in any culture one can find people fervently opposed to induced abortion and those who support it as a "right" for women's choice. The opinions expressed in the responses to questionnaires that have been conducted on opinions about genetic engineering in Japan and in New Zealand (see Sec. 4), suggest that people in these diverse countries have a similar variety of reasoning. This type of research should be conducted in other countries, especially in developing countries, if we want further objective data in order to better understand the reasoning of all people. We may find that people in many countries do share the same hopes and fears, and if this is so, the call for international standards will be strengthened.

If we look at declarations of ethical codes made by different religious groups, professional groups, and among different nations, we can see the principles of bioethics that were outlined in the above section in most. A key question in cross-cultural bioethics is how the concept of do no harm should be applied, and to what beings it applies. For example; At what stage of development should human embryos be legally protected, for in vitro research or abortion decisions? Which animals should be protected from which research or use? How do we balance justice within national boundaries with global distributive justice, and justice to future generations? How much individual liberty do we allow when individual choices affect society values and options for other people or beings? What is necessity and what is human desire or luxury? What is the level of acceptable risk of harm?

These are wide questions, and this paper will discuss some of them. For the purposes of this volume the discussion will be focused around the question of what ethical biotechnology is, and developing approaches that may allow us to better answer this question for policy development.

4 Perceptions of ethical biotechnology

4.1 "Moral" is not the same as ethical

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. What is seen as immoral is often also unethical, though unethical practices are often tolerated by a society and thus our definition of moral, would say that they are "morally acceptable" because it is "common morality". For example, people living in industrialised countries enjoy the fruits of an economic system that is disruptive to people living in developing countries and the environment. By use of basic ethical principles of distributive justice, and justice to future generations who will have to live in a polluted and changed world, we would say it is unethical. However, this situation is "common morality" to a majority of the people living in the rich countries, though the proportion may be falling, and it is morally unacceptable to the poor of developing countries. It we draw our definition of morality at national or regional borders, we would see this mixed morality standard, but if we drew our morality from a global majority we would see it as immoral.

Decisions may be made democratically in a country if a consensus supports them, if the rights of minority groups are not overtroden, and if it makes sense in the long term, both nationally and internationally. However, not all decisions made this way will be ethical, society can make unethical majority decisions and will continue to do so. In the area of biology and genetics, we should never forget the unethical compulsory eugenics that swept the world in the first half of this century, when more than 40 countries made laws to enforce mandatory sterilisation and selective immigration policies (Kelves, 1985), nor should we forget the environmental destruction that still continues today. We cannot say that these abuses are always based on ignorance, rather they are sustained by groups of people pursuing their own interests who can lead the public into following the pattern of living that will sustain the people in power in those positions. Usually appeals are made to the selfish side of human personality, that we all possess. Rather, we should be concerned with global sustainability and protection of the rights of all people.

We must remember this distinction between ethical and moral when we look at public opinion. Law is often based on the so-called common morality of a country, and in the area of biotechnology we can see varying laws established by different countries, and even within Europe there are conflicting laws, for example in the area of assisted reproduction and the use of human embryo experiments for research, Germany prohibits research as a criminal offence (Deutsch, 1992), and Britain permits approved research until the embryo is 14 days old (Bolton et al., 1992). The laws on the contained use or release of, genetically engineered microorganisms vary between different countries, due partly to different public perceptions of risk (see Chapter 1 and 2).

Whenever we consider the results of opinion surveys we need to remember the axiom, "Lies, damn lies and statistics". Nevertheless, they are an important gauge of public opinion, and when combined with the results of methods that allow the thinking behind such results to be determined, they are important in sociological study. Governments and companies involved in biotechnology research have become careful in their monitoring of public opinion, for in the case of governments it can mean they are not reelected, and public opposition to companies can be expensive in terms of time delays and lost sales.

Most people receive information via the mass media, especially the newspaper and television. The media have a large responsibility to communicate science issues well, and scientists should also inform people about science. The media has a responsibility to present balanced information, on the benefits and risks of alternative technologies and to do this independently of commercial interests. Public opinion can be influenced by groups who have a special interest, such as political groups, and other groups, whose members spend time to publicise their opinions, and who can get media coverage of their views.

4.2 Mixed perception of benefit and risk

There have been some opinion polls conducted on the topics of biotechnology, and these are the subject of Chapters 12-15. Many of these opinion polls have limited meaning because they ask set questions with set responses, allowing little room for free response. The responses are often suggestive, and cannot give us the real picture of what the public is thinking. The extra time spend in analysis of free response questions may be well worth the investment if the underlying reasoning is to be determined. Even the use of questions looking at the balance of benefit and risk are more useful than asking single questions.

In August-October 1991, a series of public opinion surveys were conducted in Japan (Macer, 1992a). Mailed nationwide opinion surveys on attitudes to biotechnology were conducted in Japan, among randomly selected samples of the public (N=551), high school biology teachers (N=228) and scientists (N=555). The results of several of the 20 questions are summarised in this chapter, as they are useful in examining what are seen as "bioethical" conflicts of biotechnology, that will be examined in section 5. The results were compared with the results of the same questions used in New Zealand in May 1990 (Couchman and Fink-Jensen, 1990), among samples of the public (N=2034), high school biology teachers (N=277) and scientists (N=258).

People were first asked about their awareness of eight developments of science and technology (Q5a), then asked whether they thought each development would have a benefit for Japan or not (Q5b). Q5c and Q5d examined their perceptions about the risks of technology by asking them how worried they were about each development. The questions were:

Q5. We will ask you about some particular scientific discoveries and developments. Can you tell me how much you have heard or read about each of these. Please answer from this scale.
1 I have not heard of this
2 I have heard of this, but know very little/nothing about it
3 I have heard of this to the point I could explain it to a friend

How much have you heard or read about?
Biological pest control Silicon chips
Biotechnology Fibre Optics
Agricultural Pesticides In vitro fertilisation
Superconductors Genetic engineering

For each of these developments that you have heard of;
Q5b. Do you personally believe (DEVELOPMENT) would be a worthwhile area for scientific research in Japan (NZ)?
1 Yes 2 No 3 Don't know
Q5c. In the area of (DEVELOPMENT) do you have any worries about the impact of research or its applications?
1 Yes 2 No 3 Don't know

Q5d. For each development where you are worried; could you please tell me how worried you are, using this scale...about the impacts of (DEVELOPMENT) ?
1 I am slightly worried about this
2 I am somewhat worried about this
3 I am very worried about this
4 I am extremely worried about this

Japanese have a very high awareness of biotechnology, 97% saying that they had heard of the word (Table 1). They also have a high level of awareness of IVF and genetic engineering. In New Zealand only 57% said they had heard of biotechnology. In a 1988 survey of 2000 public in the U.K. only 38% of respondents said they had heard of biotechnology (RSGB, 1988), considerably less than in New Zealand, and compared to 97% in Japan in this survey in 1991. The result of Q5 suggests that the Japanese public is comparatively very well exposed to the word 'biotechnology', with 34% saying they could explain it, compared to only 9% in New Zealand.

The responses revealed that there are mixed perceptions of benefit and risk from the use of these technologies (Figure 1). Biotechnology was seen to be worthwhile by 85% of the public, while 40% were worried about research. Genetic engineering was said to be a worthwhile research area for Japan by 76%, while 58% perceived research on IVF as being worthwhile, however 61% were worried about research on IVF or genetic engineering (Table 1). Japanese expressed more concern about IVF and genetic engineering than New Zealanders. People of all groups expressed a relatively high degree of worry about biotechnology, IVF and genetic engineering when compared to other developments of science and technology (Figure 2).

From the results of this question it appears that people had a mixed view of the benefits of science, however the following question in the survey asked them about their general perception of the benefits versus harms of science, and these responses were overwhelmingly favourable. Q6 addressed the general attitude to the benefit and/or harm perceived to be done from science in general. The Japanese high school biology teachers and the public gave similar responses, with 58% and 56%, respectively, thinking that they did more good than harm. Only 6% of the public and 3% of the teachers thought that science and technology did more harm. Scientists had a more optimistic picture, with 78% saying science and technology did more good and only 2% saying it did more harm than good.


Table 1: Attitudes to developments in science and technology

Values are expressed as %'s of the number of respondents to Q5 that had heard of, or could explain, each development (N). Results from Japan are from Macer (1992a), and New Zealand results are from the survey of Couchman & Fink-Jensen (1990).

Sample
Public
High School biology teachers
Scientists
Japan NZJapan NZJapan NZ

Biological pest control
Heard of (N) 4031668 211276 511256
Worthwhile 84.185.8 94.899.3 96.396.9
Not worried 43.749.7 45.434.1 60.332.4
Slightly worried 14.16.0 12.847.8 7.248.4
Somewhat worried 16.911.3 20.99.4 11.412.5
Very worried 10.922.2 12.33.6 8.43.9
Extremely worried 4.29.6 4.70.7 2.20.8
Don't know 26.00.7 8.20 3.72.0

Biotechnology
Heard of (N) 5161151 217253 542225
Worthwhile 84.971.7 93.584.6 97.481.3
Not worried 38.268.4 35.042.3 53.746.2
Slightly worried 14.12.5 8.339.5 11.439.1
Somewhat worried 16.96.0 22.66.7 16.46.2
Very worried 13.014.3 20.72.0 11.60.4
Extremely worried 8.57.2 8.30.4 6.10
Don't know 21.51.6 6.99.1 4.48.0

Pesticides
Heard of (N) 5091861 217259 533241
Worthwhile 89.284.5 87.679.2 94.782.2
Not worried 27.138.9 24.07.7 43.915.4
Slightly worried 7.914.2 6.022.4 7.130.7
Somewhat worried 14.918.1 13.432.4 16.728.6
Very worried 25.122.1 29.018.9 20.613.3
Extremely worried 18.16.3 22.613.1 11.18.3
Don't know 16.10.4 7.30 2.63.7

Genetic engineering
Heard of (N) 4951492 214273 540247
Worthwhile 76.257.4 91.685.7 94.479.8
Not worried 19.443.8 16.410.6 43.314.2
Slightly worried 11.114.6 7.937.4 11.339.3
Somewhat worried 18.213.8 14.531.9 16.522.3
Very worried 21.418.6 31.310.6 17.213.8
Extremely worried 19.88.2 25.28.4 12.88.9
Don't know 19.80.9 7.91.1 3.21.6

In a 1989 public survey in the U.K., (N=1020) for the same question, only 44% answered "more good", 37% said "about the same", 9% said "more harm", and 10% "didn't know" (Kenward, 1989). These results were similar to the U.K. in 1985, and indicate that British are less optimistic in outlook about science and technology than Japanese. In Australia, in 1989, 757 public were asked the same question, and 56% said "more good", 26% said "about the same", and 10% said "more harm", with 2% saying they "didn't know" (Anderson, 1989). Japanese share similar optimism to Australians. Internationally, the most optimistic respondents to this question were respondents to a 1989 survey in Beijing, China (N=4911), where 82% said more good, 2% said more harm, 12% said the same and 5% said "don't know" (Zhang, 1991).

In most countries science and technology has been promoted as being of benefit to people, by government and industry. These promotion campaigns appear to be working, especially in Japan and China. One could speculate whether this lower perception of good coming from science and technology in the UK is due to the lower profile of such campaigns there, or exposure to more of the bad effects of science and technology, or the current bad economic conditions in the U.K. in what was the birth place of the industrial revolution.

Awareness of the developments of science and technology in Q5 was not directly correlated with the perception of these technologies. The responses are more complex than Q6 may indicate, for example, New Zealand scientists and high school teachers expressed more general concern about the impact of all developments in Q5 than their peers in Japan, whereas the New Zealand public expressed less concern about all these developments than the Japanese public!

4.3 Reasoning behind acceptance or rejection of genetic manipulation

It is apparent that people do, on balance, see more benefits coming from science than harm. However, at the same time people also perceive risks, such as human misuse of technology. We need to determine more about these perceptions. More specific questions than those asked in Q5, were used in Q7 (Macer, 1992a). Rather than testing concerns about the techniques included by the broad term "genetic engineering", the views of genetic manipulation on four types of organisms were examined: humans, animals, plants and microbes, with room for free response to list reasons for acceptance, benefits and risks perceived. The questions were:

Q7. Can you tell me how much you have heard or read about...?
Manipulating genetic material in human cells
Manipulating genetic material in microbes
Manipulating genetic material in plants
Manipulating genetic material in animals
Use this scale...
1 I have not heard of this
2 I have heard the words but no more
3 I have heard the words and have some understanding of the idea behind it

Please answer the questions below:
Q7b. Which, if any, of those biological methods you've heard of are acceptable to you for any reason?
1 Acceptable
2 Unacceptable (If unacceptable write why each one is not acceptable to you)

Q7c. Which of those biological methods, if any, of those you've heard of could provide benefits for Japan?
1 No benefit
2 Benefit (If a benefit, what benefits do you believe each one could produce?)

Q7d. Which, if any, of those biological methods could present serious risks or hazards in Japan?
1 Risk
2 No risk (If a risk, what serious risks or hazards do you believe each one could present in Japan?)

In both Japan and New Zealand, genetic manipulation of plants is the most acceptable type, followed by genetic manipulation of microbes, animals and humans, in order of decreasing acceptability (Table 3). About half of the teacher and scientist samples think that human genetic manipulation (human cells) is acceptable, in both countries. This preference order is the same as that obtained in the USA in November 1986 (OTA, 1987). This could represent two major thoughts, a scale of biological complexity associated with increasing ethical 'status' from microbes to plants to animals to humans. This is complicated by the higher perceived danger of genetic manipulation using microbes, which are associated with disease and which are environmentally more mobile, and animals which are mobile. The results of questions on the benefits and risks (Q7c,d) found most people perceived both benefit and risk, as in Q5. The results for public and scientists are schematically represented in Figure 3.

The reasons for unacceptability, benefit or risk perception were asked, and they are perhaps the most interesting result. For different organisms they were different, reflecting reality. This is particularly useful for those working on an organism such as microorganisms, the focus of this book series, for the perceptions will vary greatly from those associated with human genetic manipulation. The method used to analyse the reasoning was to assign the comments to categories. A total of 38 different categories were used in the computer data analysis, some of which were later combined in data presentation. Although a variety of comments were written, generally they could easily be assigned to categories. For each distinct reason given in the comment, a count of 1 was scored in one of the categories of the data sheet in the computer. The most reasons given for a single comment was 3, but generally there were only 1 or 2 reasons. Also, a high proportion did not write any comment. A summary of the reasoning is presented in Tables 2, 3 and 4.

University students and academics in social sciences were also surveyed in Japan, the results and many examples of the actual comments, are in Macer (1992a). Interestingly, more public wrote comments for reasons for acceptability than scientists.

The major reasons cited for the unacceptability of genetic manipulation (Table 2) can be grouped into categories:
1. Unnatural, playing God, unethical, feeling
2. Disaster, fear of unknown, ecological and environmental effects
3. Human misuse, insufficient controls, eugenics, cloning, humanity changed
4. Health effects, mutations
5. Not stated.

Group 1 concerns may persist with development of the technology, but group 2 and 4 concerns may be lessened by development of technology. Group 3 concerns can be lessened by regulations, as will discussed in section 8. People who did not cite a reason may feel less strongly about the issue, but there is no real indication of what concerns they had. We should also note that many people expressed reasoning across several of these types of concern.

The most common response in both countries for a benefit from genetic manipulation of human cells were medical reasons, as from microbes where the benefit of making useful substances was also often cited (Table 3). Economic benefits were not cited much, with more respondents in New Zealand listing these benefits, perhaps because the economy is so dependent upon biotechnology, in terms of agriculture, and the economic recession has been much harder there. In the reasons cited for genetic manipulation of animals, many more New Zealanders cited disease control of animals, as a reason. In both countries similar proportions cited "new varieties" or "increased production and food" as the main benefits of genetic manipulation of plants and animals, with a trend for more New Zealanders to cite the later.

There was also a wide diversity of responses to the reasons why people perceived risks from genetic manipulation (Table 4). The frequency of the common responses to Q7d did not differ greatly from those given to Q7b, though many respondents listed different reasons in response to these two questions. The risks were in general more involving human misuse, and activity, rather than abstract concerns such as "interfering with nature". They were also more specific, so that more respondents listed deformities and mutations as a problem. In addition to ecological and environmental concerns, there was also substantial numbers who cited a risk connected with the spread of genes, viruses, and GMOs, generally labelled "biohazard" in the categories in Table 4. A few said that science was always associated with danger.


Table 2: Reasons given for Unacceptability of Genetic Manipulation

The values are expressed as %'s of the total respondents who answered Q7; in Japan, public N=509, teachers N=222, scientists N=535 (Macer, 1992a); and New Zealand, public N=2034, teachers N=277, scientists N=258 (Couchman and Fink-Jensen, 1990). Organism: H=human cells, P=plants, M=microbes, A=animals; Group: P=public, T=high school biology teacher, S=scientist; The absence of data is indicated by '-'.

Japan
New Zealand
Organism
Group
H
P
M
A
H
P
M
A
% who said it was acceptable P

T

S

26.0

46.6

54.6

80.9

87.8

92.5

72.8

82.4

89.9

54.2

75.6

24.4

42.5

48.7

53.8

85.4

87.3

82.7

71.1

72.2

75.2

56.4

81.6

77.4


Unacceptable for the following reasons (% total respondents):
Interfering with nature,

Unnatural

P

T

S

12.3

3.6

2.8

4.7

2.2

1.1

4.1

2.2

1.3

9.5

3.6

2.4

16.1

5.1

3.7

5.1

1.4

2.6

6.4

1.0

2.0

9.6

3.0

3.2

Playing God P

T

S

10.8

5.0

4.5

2.3

0.9

0

2.0

0.9

0.4

4.9

1.3

1.5

-

-

-

-

-

-

-

-

-

-

-

-

Unethical P

T

S

4.9

9.4

6.0

0.2

0.4

0.2

0.1

0.5

0

3.0

2.4

2.2

9.2

22.1

3.7

-

0

-

-

0

-

15.2

6.1

2.7

Disaster, out of control P

T

S

5.1

2.2

1.9

0.6

1.8

0.6

1.2

4.5

1.7

2.6

2.3

1.5

9.2

6.2

6.5

1.7

1.1

3.6

3.5

5.4

8.7

3.9

3.3

4.5

Fear of unknown P

T

S

6.1

7.2

6.5

1.8

0.9

1.1

1.5

1.8

1.7

4.7

2.7

2.4

4.6

5.6

4.6

1.6

1.2

2.2

4.6

1.5

4.2

3.5

3.3

4.1

Ecological Effects P

T

S

5.7

1.4

0.8

5.1

2.2

0.9

3.8

1.8

1.3

6.5

3.2

1.9

-

0

0

1.7

0.9

3.6

-

0.5

1.5

5.2

0

0.5

Feeling P

T

S

4.9

0.5

1.9

1.8

0

0.2

1.8

0

0.4

3.1

0.5

1.5

-

-

-

-

-

-

-

-

-

-

-

-

Humanity changed P

T

S

3.1

1.8

1.9

0

0

0

0.1

0

0

0

0

0.2

-

3.1

3.2

-

0

-

-

0.5

1.0

-

0.4

0.5

Insufficient controls P

T

S

2.8

5.0

9.0

0.2

2.2

0.4

0.1

3.1

0.2

1.2

3.2

2.2

4.0

9.8

9.7

1.2

1.4

4.8

2.9

2.6

7.7

3.0

4.4

6.1

Danger of human misuse P

T

S

3.0

2.2

4.1

0.6

1.7

0.7

0.4

2.3

0.6

1.7

2.3

1.5

5.2

6.2

5.1

1.2

0.2

1.7

3.8

1.8

4.7

2.6

1.3

2.7

Eugenics, Cloning P

T

S

3.7

4.5

2.2

0

0

0

0

0

0

0.2

0

0.6

2.9

5.1

2.3

-

0

-

-

0

-

-

0

-

Deformities, mutations P

T

S

1.7

1.4

1.2

0.2

0.4

0

0

0

0

0.6

0.9

0.2

1.7

1.1

0.9

-

-

0.5

-

-

0

0.9

0.4

1.4

Human health effect P

T

S

0.8

0.9

0.8

0

0.4

0

0.8

1.4

0.6

0.2

0.5

0.4

2.9

1.5

-

-

0

0.5

0.9

2.6

0.5

-

0.4

0.9

Not stated P

T

S

19.5

0.9

12.7

4.9

2.7

3.7

7.3

3.6

3.9

13.6

6.8

7.7

5.2

-

1.4

3.6

-

0.5

9.5

-

1.0

4.4

-

0.9

Table 3: Benefits of genetic manipulation cited by respondents

The values are expressed as %'s of the total respondents who answered Q7; in Japan, public N=485, teachers N=221, scientists N=518 (Macer, 1992a); and New Zealand, public N=2034, teachers N=277, scientists N=258 (Couchman and Fink-Jensen, 1990). Organism: H=human cells, P=plants, M=microbes, A=animals; Group: P=public, T=high school biology teacher, S=scientist; The absence of data is indicated by '-'.

Japan
New Zealand
Organism
Group
H
P
M
A
H
P
M
A
% who saw a benefit P

T

S

37.7

53.5

60.8

78.9

86.8

88.0

68.5

80.5

86.5

53.1

71.0

74.3

48.4

59.8

55.0

87.5

96.6

94.2

62.7

81.2

81.9

66.4

81.6

81.6


Reasons cited as benefits (% total respondents):
Cure or prevent genetic disease P

T

S

8.3

24.4

24.1

0.4

0

0

0.2

0

0

0.2

0.5

0

10.6

29.9

20.9

-

0

0

-

1.6

0

-

0

0

Disease control P

T

S

5.4

10.0

11.8

2.7

5.2

6.4

2.3

1.8

1.9

1.2

3.6

2.7

15.0

7.2

11.0

1.7

42.5

35.8

16.9

13.8

7.4

10.6

26.9

22.0

Medical advance, Cancer cure P

T

S

5.4

9.1

7.0

1.9

2.2

1.7

10.1

10.9

7.1

2.7

5.9

4.4

8.7

16.7

31.9

1.7

19.3

2.8

8.2

3.2

18.8

2.0

6.5

4.9

Make medicines P

T

S

0

0.5

0.2

0.2

0

0.6

4.4

23.1

9.3

0

0.5

1.9

-

-

-

-

-

-

-

-

-

-

-

-

Make useful substances,

Industry

P

T

S

0.2

0

0.6

1.3

2.2

4.3

2.3

14.8

20.5

0.8

1.8

5.2

-

-

-

-

-

-

-

47.1

37.7

2.0

-

-

Scientific knowledge P

T

S

0.6

3.2

3.1

0.2

3.0

3.3

1.4

4.5

4.6

1.8

6.8

8.1

3.4

0.6

1.1

-

3.9

1.9

6.3

0.8

6.6

4.0

1.6

2.4

Agricultural advance P

T

S

0

0

0

2.0

6.7

3.8

1.0

3.1

1.6

0.4

4.5

2.7

-

-

-

19.2

23.2

20.7

8.2

20.3

24.6

6.6

11.4

8.2

Increased yield,

to make more food

P

T

S

0.4

0

0

16.9

18.8

23.0

4.7

7.2

9.1

8.0

11.8

13.5

-

-

-

20.1

40.6

44.3

-

0

-

10.6

31.8

31.0

Different varieties P

T

S

0

0

0

11.5

27.6

22.4

1.9

3.6

5.8

6.8

19.9

16.4

-

-

-

17.5

29.0

22.6

-

0

-

-

12.2

10.6

Increased quality P

T

S

1.9

0

0.8

9.7

3.8

3.5

2.5

0

1.7

5.0

6.7

3.5

-

-

-

33.2

21.3

24.5

-

-

-

32.5

32.6

36.7

Exports increase,

economics

P

T

S

2.3

0.5

0.9

3.5

0.4

3.8

3.7

0.5

4.6

3.5

0.5

2.9

1.9

0

1.1

7.9

2.9

10.4

1.3

7.3

4.1

7.3

7.3

11.4

Environmental advantage P

T

S

0

0

0

3.6

1.5

5.3

4.9

1.8

5.4

1.4

0.5

1.0

-

-

-

-

-

-

6.9

-

-

-

-

-

Humanity benefits,

Whole world benefits

P

T

S

5.1

1.8

5.4

8.0

4.2

6.1

7.4

6.8

6.9

6.6

7.2

6.0

10.6

2.4

6.0

2.6

0

0.9

5.6

0

4.9

4.0

0

1.6

Doubtful benefit P

T

S

0.4

0.9

0.8

0.6

0.7

0.8

0.4

0.9

0.8

0

0.5

0.6

-

-

-

-

-

-

-

-

-

-

-

-

Benefit not stated P

T

S

12.8

8.6

14.1

30.1

15.0

26.3

25.8

17.2

26.1

19.4

20.5

22.0

9.7

-

1.6

7.0

-

3.8

18.8

-

4.9

9.3

-

2.4

Table 4: Risks of genetic manipulation cited by respondents

The values are expressed as %'s of the total respondents who answered Q7; in Japan, public N=485, teachers N=221, scientists N=518 (Macer, 1992a); and New Zealand, public N=2034, teachers N=277, scientists N=258 (Couchman and Fink-Jensen, 1990). Organism: H=human cells, P=plants, M=microbes, A=animals; Group: P=public, T=high school biology teacher, S=scientist; The absence of data is indicated by '-'.

Japan
New Zealand
Organism Group
H
P
M
A
H
P
M
A
% total who saw risk P

T

S

83.3

85.6

70.8

39.5

54.7

42.9

53.6

69.6

51.7

61.3

68.7

54.3

74.4

43.9

56.7

42.4

25.6

38.9

67.4

57.5

56.1

58.4

25.0

43.3


Reasons cited as risks (% total respondents):
Unethical, ethical abuse P

T

S

3.9

10.4

7.1

0

0

0

0

0.4

1.0

1.4

2.3

3.7

12.3

13.6

-

0

0.5

-

0

0

3.5

4.5

3.5

Playing God, unnatural P

T

S

7.2

4.1

2.7

2.5

0.9

1.7

3.1

0.9

1.5

4.9

2.2

2.7

6.0

3.5

1.1

5.5

4.1

5.1

4.7

2.3

1.7

5.3

3.8

4.3

Disaster, out of control P

T

S

5.3

2.7

4.2

2.3

5.9

2.5

3.7

7.7

3.3

3.7

5.0

3.9

18.6

6.6

12.5

10.6

4.6

11.3

16.8

25.3

26.9

12.3

5.0

11.7

Fear of unknown P

T

S

9.7

10.4

10.2

6.8

8.2

7.5

7.8

9.0

7.9

8.5

9.5

7.9

9.7

4.4

10.2

5.1

3.1

9.3

7.4

4.6

8.0

7.6

2.0

9.5

Ecological effects P

T

S

7.4

5.4

3.4

9.1

14.5

10.0

8.9

14.0

7.3

12.1

15.4

10.6

-

0

0

5.1

10.2

5.1

3.4

6.3

7.4

6.4

4.5

6.9

Biohazard, spread of genes P

T

S

0.6

1.8

1.7

1.9

9.5

3.3

2.9

5.9

3.7

1.5

12.7

2.5

-

1.8

-

5.1

0.5

4.6

-

18.4

5.1

3.5

1.3

-

Danger of human misuse, Biowarfare P

T

S

8.4

11.7

15.8

4.1

5.5

9.9

6.6

9.5

11.8

4.9

6.4

11.0

8.2

7.5

9.1

3.4

2.3

5.7

6.7

2.9

7.4

5.3

3.0

4.8

Eugenics P

T

S

3.5

8.2

5.0

0

0

0

0

0

0

0.4

0.9

0.6

-

-

-

-

-

-

-

-

-

-

-

-

Cloning, human reproduction abused P

T

S

2.2

3.2

1.9

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

-

-

-

-

-

-

Humanity changed P

T

S

5.2

2.7

6.8

0

0

0.8

0

0

0.6

0.4

0

1.2

7.0

3.5

2.8

-

0

0

-

0.6

0

-

0.8

0.9

Deformities, mutations P

T

S

4.9

10.0

4.2

1.5

2.3

1.7

0.4

2.7

1.5

2.1

5.0

2.1

17.1

4.8

1.1

-

0

0

-

0

0

6.4

2.0

0.4

Insufficient controls, need public discussion P

T

S

4.5

3.2

7.0

2.2

3.2

5.6

2.2

3.6

5.6

3.3

3.1

6.2

8.2

4.4

10.8

6.4

3.8

10.8

15.5

4.6

9.1

7.0

4.0

8.7

Economic corruption of safety standards P

T

S

1.0

0.4

1.1

0.8

0.5

1.2

0.8

0

1.2

1.0

0.5

1.2

-

-

-

-

-

-

-

-

-

-

-

-

Not stated P

T

S

33.2

23.6

22.0

13.8

13.6

12.1

19.8

15.8

15.2

24.7

16.7

17.4

10.4

-

5.1

-

-

3.1

14.8

-

2.3

10.5

-

2.6

Table 5: Concerns about Consuming Products made from GMOs

The values are expressed as %'s of the total respondents who answered Q8; in Japan, public N=527, teachers N=221, scientists N=543 (Macer, 1992a); and New Zealand, public N=2034, teachers N=277, scientists N=258 (Couchman and Fink-Jensen, 1990). Group: P=public, T=high school biology teacher, S=scientist; Absence of data is indicated by '-'.

Japan
New Zealand
Product
Group
Dairy
Vege
Meat
Med.
Dairy
Vege
Meat
Med.
% total with concern P

T

S

51.6

34.9

36.1

41.0

31.5

32.3

55.4

36.1

38.0

50.5

35.5

28.8

42.8

13.0

24.0

38.4

9.7

21.7

48.3

13.7

24.4

34.1

9.7

19.8


Concerns cited about consuming such products (% total):
Unnatural,

will taste bad

P

T

S

6.8

5.0

4.1

6.1

4.5

3.7

8.5

4.5

4.2

5.7

3.1

3.0

11.1

1.4

2.4

12.3

1.5

2.8

7.8

1.1

2.7

7.2

1.1

2.0

Don't know what we are consuming P

T

S

0.4

1.4

0

0.6

1.3

0

0.7

1.4

0

0.4

1.4

0

6.0

1.0

0.7

4.6

0.7

0.9

7.2

0.7

0.7

3.4

0.4

0.4

Unknown health effect P

T

S

8.9

7.2

5.5

7.4

6.3

5.5

9.5

7.7

5.7

7.8

7.7

5.2

9.4

4.0

4.3

7.7

2.9

3.5

10.1

4.7

5.1

7.8

0.4

4.0

Long term risk P

T

S

2.3

0.9

2.0

2.4

0.4

2.2

2.6

1.4

2.2

1.9

0.9

1.8

-

-

-

-

-

-

-

-

-

-

-

-

New disease P

T

S

1.5

1.8

3.3

0.6

1.3

2.2

1.8

1.4

3.3

2.1

2.3

1.7

1.3

-

-

0.8

-

-

1.4

-

-

0.3

0.4

-

Side effects P

T

S

2.1

1.8

0.7

0.6

1.3

0.6

1.9

3.2

0.8

5.9

5.5

1.3

3.0

3.2

3.6

1.9

2.5

3.0

2.4

3.4

3.4

4.1

3.6

3.2

Safety doubts,

need to test properly

P

T

S

6.1

9.5

9.4

5.3

9.1

9.6

5.9

9.0

9.9

5.5

9.5

8.5

5.1

1.8

8.7

3.8

1.9

7.8

4.3

1.8

7.1

5.1

1.5

8.1

Unknown research area P

T

S

0.7

1.8

1.1

0.6

0.9

0.9

0.7

0.9

1.1

1.0

0.9

1.0

1.7

0.8

1.2

1.5

0.7

1.1

1.9

0.7

1.2

1.7

0.7

0.4

No guarantee of purity or quality P

T

S

1.3

1.8

4.6

1.3

2.2

3.3

1.1

2.3

4.6

1.3

2.3

3.3

1.3

-

-

1.5

-

-

1.9

-

-

0.3

-

-

Because it is food,

daily use

P

T

S

1.5

0

0.2

1.5

0.4

0.2

1.9

0.4

0.2

1.1

0

0

-

-

-

-

-

-

-

-

-

-

-

-

Environmental effects P

T

S

0.7

1.4

0.7

0.7

1.8

0.7

0.7

2.3

0.7

0.8

0.9

0.6

-

-

-

-

-

-

-

-

-

-

-

-

Other reasons:

Medicines -patients are weak

Dairy - give to children

P

T

S

0.9

0.9

0

0

0

0

0

0

0

0.4

0.5

0.1

-

-

-

-

-

-

-

-

-

-

-

-

Lack information,

information is hidden

P

T

S

3.2

1.8

1.8

3.0

1.8

1.8

3.4

1.8

1.9

2.9

1.4

1.7

4.7

0.8

0.7

3.8

0.7

0.9

4.3

1.1

0.7

4.1

0.7

0.4

Economic corruption of safety standards, ethical concerns P

T

S

0.7

1.4

0.7

0.7

1.3

0.7

0.9

1.4

0.7

1.1

1.4

0.7

-

-

-

-

-

-

-

-

-

-

-

-

Not stated P

T

S

17.7

8.6

8.8

12.1

7.7

9.6

19.6

9.0

9.7

15.9

8.1

7.2

4.7

0.8

2.6

4.2

0.4

2.8

5.8

0.4

3.2

4.8

0.4

1.6

In a recent European public opinion poll in the U.K., France, Italy and Germany (performed in 1990 by Gallup for Eli Lily, N=3156, Dixon, 1991), the respondents were asked to choose the largest benefit that they saw coming from biotechnology, between one of four possible benefits from biotechnology. Over half rated cures for serious diseases as the most important benefit. Another option was reducing our dependence upon pesticides and chemical fertilisers, which 26% of Italians, 24% of French, 22% of British and 16% of Germans, chose as the largest benefit.

The European respondents were asked a similar question about their largest concern. Potential health hazards from laboratory genetic research were named by 29% in Italy, 17% in France, 11% in Britain and 10% in Germany. 40% of French, 35% of Germans, and 25% of British and Italian respondents chose eugenics, and slightly lower proportions overall chose environmental harm, 34% in Britain, 33% in France, 22% in Italy and 21% in Germany.

In the European survey, overall one third of respondents feel that biotechnology is ethical and one third feel that it is unethical, and one third think it is in between, "neither". This compares to a more favourable acceptability of genetic manipulation in Japan and New Zealand, especially for nonhuman applications (Table 2). In the USA when people (N=1273) were asked whether they thought that human gene therapy was morally wrong, 42% said it was, and 52% said it was not, with 6% unsure (OTA, 1987). However, only 24% of the USA sample said that creating hybrid plants or animals by genetic manipulation was morally wrong, but 68% said it was not, 4% said it depends and 4% said they were unsure. The people who found it morally unacceptable were asked for reasons, and these reasons can be compared to those given in Table 2 from Japan and New Zealand. The US results, expressed as %'s of the total sample were that 3.1% said that it was interfering with nature, 2.8% said it was playing God, and about 1% said they were afraid of unknown results, 0.6% said it was morally wrong and did not cite a reason, and another 2-3% had other reasons. It does reinforce the idea that abstract reasons are a major concern about genetic manipulation, but further data is needed.

In the European survey, eugenics was the major concern (Dixon, 1991). However, in this Japanese survey and in the New Zealand survey, the proportion of people who cited eugenic concerns from genetic manipulation of humans was equivalent to about 4% of the total respondents, half of the proportion who expressed concern because of environmental reasons, and much lower than the number of respondents who cited reasons related to perceived interference with nature, playing God, ethics, or fear of the unknown (Table 2, 4). Because free response questionnaire data is unavailable from Europe we cannot directly compare the apparently higher concern about eugenics in Europe as opposed to New Zealand or Japan. One could speculate that it may be related to self-acknowledgement of the past eugenic abuses in Europe, and due to media coverage of the eugenic concerns raised by organised feminist and Green groups in Europe. Free response questions may provide a better estimate of people's opinions and provide a better picture of actual perceptions than agreement with suggestive concerns. Even separation of the object of the manipulation into different organisms would provide more useful information.

Another feature of the free response surveys was the low proportion of respondents who cited environmental benefits (Table 3). In the European survey, discussed above, the choice of the benefit of reduced pesticide use and environmental benefits was popular. In Japan and New Zealand further questions concerning science were included in Q16;

Q16. To what extent do you agree or disagree with the following statements that other people have made?
1 strongly disagree 2 disagree
3 neither agree nor disagree 4 agree 5 agree strongly
f. Genetically modified plants and animals will help Japanese agriculture become less dependent on chemical pesticides.

The response to Q16f, which asked if people thought GMOs would have an environmental advantage, was quite supportive (Figure 4). The free response questions (Q7c, Table 3) in Japan and New Zealand suggest that it may not actually be a common feeling. Environmental benefits of biotechnology may be very unfamiliar, despite the high level of concern expressed in Q5 about pesticides (Figure 1, 2). In both New Zealand and Japan, there should be more publicity associated with this environmental benefit, though the chemical companies who make pesticides may have different priorities (see Sec. 7). As in the risk of eugenics discussed above, we see clearly the lack of reliable data about public perceptions, at least, among what has been published.

4.4 Concerns about consuming products of GMOs

Products produced by genetically engineered microorganisms, such as human insulin or growth hormone, have been approved for medical use for over a decade (see Vol. 5 of this series). The first food products for human consumption have been approved for consumption, and it is expected that vegetable products derived from GMOs will be approved in 1993 (see Chapter 3). We can expect many products to be approved as safe for human consumption in the next few years, so a pressing question is what concerns that the public has which could result in conflict.

The views on the safety of products made by genetic manipulation were examined by Q8b (Macer, 1992a), as had also used by Couchman & Fink-Jensen (1990). 75% of the Japanese public said that they were aware that GMOs could be used to produce food and medicines, similar to 73% of the public in New Zealand, and in both countries, 97% of scientists said that they were aware of this. Free response was requested of the concerns people had:

Q8b. If any of the following were to be produced from genetically modified organisms, would you have any concerns about using them?
1 No Concern 2 Concern
For each product that you are concerned about, what concerns would you have about using it?
Dairy products Vegetables Meat Medicines

The results are in Table 5. Vegetables were of less concern, especially among the public, and meat was the product with the highest concern. Dairy products were of intermediate concern. Medicines were still of considerable concern. New Zealanders appear to be less concerned about consuming products containing GMOs or made from them, than do the Japanese. The biggest difference is in the opinions of high school biology teachers, which are very concerned in Japan. Scientists in Japan are also more concerned than their peers in New Zealand, though many Japanese company scientists showed less concern than government scientists (Macer, 1992a). The concerns included significant numbers who saw the products as unnatural (see Sec. 5.1), and who had health concerns.

There appears to be joint perception of benefits and risks as for genetic manipulation. In a European wide survey ( N=12,800, MacKenzie, 1991), 65% of people approved of genetic engineering to improve food and drink quality, but 72% said that it was "risky". In an earlier US survey (OTA, 1987), 80% had not heard of risks associated with genetic engineered products while only 19% had. However, since the time of that survey, we can expect that many people have heard of concerns about consuming products of genetic engineering. A related issue has been continued controversy about the use of genetically engineered bovine somatotropin, despite evidence that it is safe for human consumption. The latest concerns involve animal health (MacKenzie, 1992), in addition to socio-economic concerns, which will considered in Sec. 7.

5 Past and present "bioethical" conflicts in biotechnology

From the results of the above public opinion surveys, and other data, we can see which issues among the variety that have been expressed by academics and protest groups in the decades of debate over biotechnology, are common and which are not. In this section we will consider the major reasons cited for rejection of genetic manipulation research. The emotions concerning these technologies are complex, and we should avoid using simplistic public opinion data as measures of public perceptions, rather we need to address the expressed concerns and apply policy measures to lessen the conflict that people find with biotechnology. Because beneficence is a basic ethical principle, we can assume that there are important grounds for pursuing research and applying technology, providing we are consistent in respecting the other ethical principles, such as to do no harm.

5.1 Interference with nature or "playing God"

There were also significant proportions of respondents who thought that genetic manipulation was interfering with nature, or that it was profanity to God, or said that they had a bad feeling about it. Also many saw genetic manipulation, especially of humans and animals, as unethical (Table 2, Sec. 4.3). These respondents may see these techniques as unacceptable, regardless of the state of technology and regulation. In the US survey, 46% said that we have no business meddling with nature, while 52% disagreed (OTA, 1987). Although many scientists react to people with these views as irrational, it is noteworthy that about 16% of the scientists and teachers in New Zealand and Japan who found these techniques unacceptable also shared these views, and these reasons were also cited regarding genetic manipulation of microbes.

The questions about food also illustrate this concern. In Japan 12-16% of the public who were concerned about concerning products made from GMOs, said that such foodstuffs or medicines would be unnatural, while in New Zealand the values were much higher (Table 5). While rationally we can say such foods are just as natural as foods made from any modern crop or animal breed, 10-12% of scientists also said this. In a 1988 public opinion survey in Britain, 70% agreed that "natural vitamins are better for us than laboratory-made ones", while only 18% disagreed (Durant et al., 1989). In fact the use of varieties bred using genetic engineering should allow the avoidance of chemical pesticides and preservatives during crop growth, food storage and processing, which could actually make such foods "more" "natural".

We have yet to understand what people believe nature really is. It is a changing concept and varies between individuals, religions and cultures. As societies become urbanised they lose touch with nature. However, there is also a recent trend to buy products from "organic farming", or preferences for "free-range eggs" over eggs from battery farmed chickens. All people have some limit in the extent to which they support changing nature, or the application of technology. Bioethics still needs to be developed in order to approach this abstract area of thinking. In the meantime, scientists as well as the public, perceive limits to what is acceptable, or "ethical", biotechnology, and further research is needed to determine what these limits are.

By reducing the use of chemicals in agriculture, food processing, and medicine, biotechnology may actually be able to make these areas more "natural". Also, if efficiency of agriculture is increased, and genetic diversity increased, biotechnology may allow some agricultural land to revert to more random natural vegetation. The potential is there, if society demands it. However, increased use of microorganisms for industrial and environmental processes may lessen the use of chemicals in these applications, would this also lessen people's concern - or raise it?

5.2 Fear of unknown

In general the other frequently cited comments in all sample groups for all organisms were connected with the unknown nature or danger of the results of genetic manipulation. Some people saw this in terms of a disaster, while others have less dramatic concerns. There is also fear associated with unknown research fields, which is true of any area. We could subdivide this concern into health and ecological concerns.

5.2.1 Unknown health concerns

Fear of the unknown was found to be a common concern that people had about genetic engineering (Table 2, 4). Fear of health effects are related to this, and were also common. When asked a later question concerning food safety, the principle concern was regarding health effects, including side effects (Table 5). This represented the principle, to do no harm. It is a responsibility of developers, and marketers of new varieties of GMOs and products from GMOs. Sufficient regulatory procedures should be in place already as for existing products, and further regulations have been added in some countries (like Japan or EC) but not in others (like the USA), (see Sec. 5.3, 8.1; Chapters 1 and 4).

5.2.2 Environmental and ecological risks

There is growing concern about environmental issues, which must be welcome by all who are concerned about environmental ethics and justice to current and future generations. Part of the reason for the increased concern has been recognition of global pollution that human activity has caused, and a fear for the survival of the planet (WRI, 1992). The phrase sustainable technology has been added as an ethical criteria of technology. Clearly, with the changed UV light and predicted increased temperature and climate change, the current conditions are not sustainable - rather we need to look at the steady state that may be possible to stabilise in another century.

Nevertheless, the earlier we act the less different the future world will be, and sustainability has become recognised as an ethical criteria of technology. Any biotechnology which is in conflict with this principle will be called "unethical". As discussed in section 5.1, biotechnology has potential for ecological improvement, if applications are targetted with that objective. The ecological concern that many people have concerns introduction of new organisms into the environment, including GMOs. Ecological studies are needed, and monitoring of releases of GMOs, to gain data to allow prediction of the ecological impact of such introductions. Some data is already available, after the approximately 500+ field tests of GMOs already performed, and until safety has been demonstrated for each GMO in question we should not have commercial introduction of large scale. We should support programs such as the PROSAMO study in the U.K. which are designed to provide methods to monitor the release and survival of GMOs (Killham, 1992). In the cases where safety has been shown, and in cases where the GMO presents less ecological risk than the current varieties, we should use the GMO. It is basic risk management. It is the topic of other chapters of this volume, see Chapters 4, 5 and 16 in particular.

5.3 Regulatory concerns

There was also much concern expressed in Japan and New Zealand about insufficient controls, especially by teachers and scientists. If what are seen to be safe and adequate controls are established, the people who had these reasons for objecting to genetic manipulation, may accept it. It is up to the researchers to prove that the results represent an acceptable level of risk, and to adjust regulatory procedures to those that are seen to be adequate. A discussion of the regulation of biotechnology is in Sec. 8, and biosafety is discussed in Chapters 1 and 4 of this volume.

There was also qualified acceptability by some respondents, depending on the introduction of appropriate control measures. About 7% of scientists and teachers, and 2% of public, wrote such comments for plants and microbe applications, and 19-25% of all respondents in Japan who said that these techniques were acceptable wrote such comments for genetic manipulation of human cells, (Macer, 1992a). The actual number of respondents who were concerned about controls should include these respondents in addition to those who said that the area was unacceptable because of insufficient controls. It may be significant that such a high proportion of respondents who said that the techniques were acceptable, did spontaneously write down some qualification to their response choice.

Field releases of GMOs are regulated in all countries of the world, officially, as they should be (Macer, 1990, Chapter 1, 2, and 5). The procedures vary, as does the public satisfaction with such procedures. They are also subject to political climate, and bureaucratic regulations conflict with industry and with the principle of beneficence, whereas inadequate regulations risk harm, as discussed above. Most countries are shifting to a product-based system, which is more scientific than a system of exclusion or inclusion based on production method. However, the exclusion categories of organisms from regulations may be broadened so much as to conflict with sufficient protection of human and ecological safety.

In 1992 the US FDA said that they would not impose any special regulations on GMO food products (Kessler et al., 1992). This has pleased industry (Fox, 1992), but it may lead to more people having fear of what they perceive are unknown food products. In the European Community and Japan, a committee will examine each case, to determine whether extra safety tests are required (Macer, 1992a). Here we see different balancing of ethical principles, beneficence versus do no harm. It remains to be seen how much conflict there is in the acceptance of food made from varieties bred using genetic engineering, it may depend on possible future cases if harm is related to such products.

5.4 Human misuse

There was also concern about human misuse of these techniques, which again, could be eased by further guarantees over who uses these techniques. For human beings, another major response was concerns about eugenics, and cloning. These fears may be eased by the introduction of laws, but we should note that in Europe where there are some laws to prevent such abuses, there is still much concern with eugenics (see Sec. 4.3, 8.2). It may be good to maintain a high level of such fears in society as the most effective method to prevent future abuses of biotechnology from being made. However, it is important that people learn to distinguish medical uses of genetics from racial applications that are associated with the word eugenics. They can already distinguish between applications involving different organisms.

A related issue, and one more relevant to microbial biotechnology, is the use of biotechnology in biowarfare research. Biotechnology is being applied to military research, to develop biosensors to detect poisons, and to improve immunity (NRC, 1992). If the motive is defensive, and the results are distributed to the general public, globally, we could find ethical justification for such research. However, such research would conflict with ethics if it is not shared with all people, and if there is any possible escalation of offensive biological warfare research. We cannot eliminate the possibility that biotechnology will be applied to biowarfare development by individual terrorists, so such defensive research could have benefit. Additionally, any research to improve immunity will be useful as we face infectious diseases, and in the future as the increased incidence of UV light may decrease our immunity. We can only attempt to ensure that biotechnology is not misused.

6 Future "bioethical" conflicts in biotechnology

6.1 Changing perceptions of nature

As discussed in Sec. 5.1, a significant proportion of people, including scientists, see genetic manipulation as interfering with nature. As will be discussed in Sec. 8.2, people who said genetic manipulation of human cells is playing God, may still support medical use of human gene therapy, or environmental applications of GMOs (Macer, 1992a, 1992c). This represents the most common reason why people may overcome their fear of playing God, to treat disease. Disease is natural in the sense that it may not involve human action, but it can be perceived as unnatural when it is curable. There are of course limits to this change, as we will all die - death is natural. What is thus important is not whether it is natural or not, but whether we should treat it or not. In medicine, there are other words which distinguish these concepts, ordinary treatment and extraordinary treatment.

This already presents conflicts to the unlimited use of biotechnology, such as life support technology used in intensive care. We can expect these conflicts to become more familiar and more common, in questions such as which genes do we consider important to "fix" in gene therapy?, which genes do we perform genetic screening for?, what is disease?, how far do we genetically engineer animals as transgenic production systems for pharmaceuticals?, and how far do we transform our environment with genetically modified plants for agriculture and ornaments?, and should we introduce genetically-engineered microorganisms into the wide environment in efforts to clean up pollution, by removing or degrading toxic chemicals or heavy metals?

The list of questions is enormous. Biotechnology may not have a fundamental conflict with nature, and many would see new technology as a gift from God, however we must not confuse ourselves with God. We are likely to make mistakes in the future, and apply technology too far. One basic criteria for examination of the extent to which we should proceed and what is ethical application of technology is that we should not use technology which will mean that future generations lose the possibility of reverting back to social and environmental conditions that existed in our generation. This may mean that we limit the introduction of genetically engineered microorganisms into the wider environment, though, many may arise via the selective pressures present in polluted environments. Are these selected organisms different from specifically designed ones?, are they any safer?, we would say in general no.

However, elimination of disease is ethical biotechnology; there should be no objection to the elimination of human diseases, such as smallpox. There may be more debate about the elimination of recessive disease-causing alleles, that may have some unknown advantage, like the sickle cell anemia trait which offers improved protection against malaria, but no baby should be denied the possibility of therapy for the disease, be it by safe gene therapy or other options. However, carriers may want to eliminate their risk of transmitting a harmful allele to their offspring - what is called germ-line gene therapy. This is another future conflict that faces us, even if we enact regulations that prohibit germ-line gene therapy for the present, we cannot escape the question in the future.

6.2 Pursuit of perfection - a social goal

The paradigm of beneficence argues that we should pursue benefit. This is sometimes confused with pursuit of perfection. As any human being carries 10-20 lethal recessive alleles, no one is perfect, and we can never expect to become "perfect" genetically. Because social standards also differ, no one will be socially "perfect" to all. Thus the pursuit of perfection is impossible. There is also no perfect environment, or food, we all have different preferences, and we must also weigh the ethical interests of other organisms.

However, ideals of phenotype are not impossible. A recent example illustrates this, the case of using recombinant human growth hormone to make short children, without a growth hormone gene defect, tall (Diekama, 1990). Such a study was supported by the NIH in the USA, and is under some ethical review (Stone, 1992). Is this ethical biotechnology? Support for it only comes from the recognition of parents autonomy - however, we already limit this when it may damage the child or society. Is it a waste of resources? It is a waste of health care resources, but is it any worse than spending large sums of money on luxury pursuits?

The principle objection must come from the social effect of allowing parents to make their children taller by extraordinary methods (though good food may have an equal effect), which is consistent with a social ideal that tall children are better - which is inconsistent with human equality and could have harmful social consequences. It also has harmful environmental consequences, as big people use more resources. Above all, such treatment recognises a failure of society to tolerate differences, and if it is approved, suggests society has given-up. If this is so, we can expect further discrimination against those who are different from a narrowing social norm.

This argument applies to all cases of treating abnormality - however, the crucial ethical factor that means that it is ethical to treat someone with a serious genetic disease and it is not ethical to perform cosmetic therapy like that example, is that the principle of beneficence demands us to assist those who suffer from disease, be it mental or physical, but the principle of do no harm to society asserts that we do not develop a society less tolerant of abnormality. We balance these two principles in favour of individual beneficence when the disease is serious.

Another example of this is the pursuit of efficiency in agriculture. Battery farming of chickens may have been somewhat cheaper than free range farming, however, in Switzerland and Sweden it is being rejected due to ethical reasons. As agricultural systems to more efficiently feed animals are developed, people may say that these are unethical, and prefer to pay a little extra price for having free range animals. Perhaps the economists may even redo their equations and find the tourist income from grazing sheep scenes more than compensates for a possible higher production cost compared to factory farming. If we have sufficient production capacity, and some would say even if not, there is no ethical excuse for animal cruelty. Biotechnology has the potential to increase production efficiency so that more free range animal systems, can be used. The question of whether this will happen, is addressed in Sec. 7.

6.3 Limitation of individual autonomy

The above example about growth hormone illustrates the conflict between individual autonomy and society. Autonomy must be limited by society in order to preserve the autonomy of all individuals to an equal degree. Ethically, we should apply this globally, based on justice and equality of human rights, so that individual autonomy should be limited.

A clear contradiction to this comes in the policies on environmental use. Currently, industrialised countries produce much more pollution, and use much more environmental resources that developing countries. Should any person use more than their share of communal environmental resources or produce too much pollution? Yet, societies who like to claim high value on liberty claim that individuals can use their money to satisfy their desires, with no reference to these factors. The only way to combat this selfish greed, that most of us possess, would be to introduce fair environmental quotas.

A different issue is whether we should prevent individuals from exposing themesleves to risky behaviour. We allow individuals to play dangerous sports, but we impose stricter limits on occupational health. Already there are some genetic risk factors identified that could be used to screen out workers at high risk in particular environments (Draper, 1990). Should society be paternalistic, or should it let individuals have freedom. As further genes are identified for genetic predispositions we will have more issues at stake.

6.4 Human genetic engineering

In the future when techniques for targetted gene insertion become safe to use on humans, treatment of non-disease conditions will be called for. It is a further issue whether it is ethical to attempt to improve the genes of humans as we may do with agricultural organisms. Although such genetic engineering would be considered unethical by many people today, it is likely that this conflict will arise when increasing numbers of people want to improve on characters such as immunity to disease, improve the efficiency of digestion of foodstuffs, or numerous psychological or social traits. Immunization by gene therapy entered a clinical trial in 1992 (Anderson, 1992b), so it may be a more immediate prospect. These applications will be a future conflict, and it is also related to the above question of when individual autonomy should be restricted.

7 Bioethics versus business: a conflict?

In short, the answer is yes, the reason is that ethical concerns rely on principles such as just distribution of wealth and equality, and on factors such as beneficence. However, the goal of business is to make profit, and many businesses aim at economic growth and high profits. Biotechnology may allow production of consumer goods from renewable biomass sources, however, energy is still required to transform raw materials into finished products, thus economic growth requires continual energy input. The economic policies, based on Schumpter Dynamics, are not compatible with sustainable development (Krupp, 1992), therefore if biotechnology aims to be ethical it must use a different economic theory. When businesses consider raw materials they may attempt to use the lowest cost materials, which may mean that international common assets such as environmental resources are used, the so-called problem of the commons. They may also ignore the future costs of pollution caused by the production and use of technology.

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 (OTA, 1991c). See also Chapter 6, 7 and 17. Some of the conflicts relevant to ethical biotechnology are discussed below.

7.1 Intellectual Property Protection

There are several forms of intellectual property protection, and they are outlined in Chapter 17 of this volume. There continues to be much controversy regarding the patenting of plants and animals, and of genetic material form living organisms, especially humans. There is less controversy regarding patenting of microorganisms.

Patents and variety rights are supported to act as incentives for technology development, consistent with beneficence. However, should there be subject matter which is exempted from patent protection, such as plant and animal varieties are exempted in the clause 53(b) of the European Patent Convention? There is also a question of what is novel, when gene sequences consist of information that is already existing in nature - even though this information can be shuffled into new vectors. Another question that is important for the future of biotechnology patents and for gene sequencing patents is whether the application of robotic sequencing methods is non-obvious. The policy should be made considering all the economic, environmental, ethical and social implications, and it should be internationally consistent.

In 1991 a controversy arose when a a single patent application for 337 human genes was made in the USA, and in February 1992 a further application for patents on another 2375 genes was also made by the NIH (Macer, 1992a). Modern technology has the ability to sequence all of the 100,000 human genes within several years. However, there is no demonstrated utility so this type of broad application is expected to fail, regardless of ethical or policy issues. The patents were applied for on behalf of the US National Institutes of Health, though many inside the NIH are against it (Roberts, 1992). This government body may sublicence particular US companies to pursue research on these genes in an attempt to "protect" the US biotechnology industry from international competition.

Researchers in Britain, France and Japan are also obtaining many gene sequences (including some of the same genes and sequences), so a patent war may begin, and international scientific cooperation in the human genome project will be seriously damaged. The US Patent Office is expected to make a relatively quick decision on the validity of such patents, but more applications are expected just in case a patent office recognises such applications. Government action to prevent such patents on random cDNA fragments has been widely called for (Kiley, 1992). The French government, and Japanese genome researchers (Swinbanks, 1992), have announced that they will not apply for similar patents because of ethical reasons. England's Medical Research Council (MRC) has applied for a similar patent on more than 1000 genes, though England is joining France in calling for an international agreement to waive any of these patents if they should be granted (Aldous, 1992).

The human genome is common property of all human beings, and no one should be able to patent it (Macer, 1991b). Public opinion could force a policy change regarding the patenting of genetic material, even if it is judged to be legally valid. People in Japan and New Zealand were asked if they agreed whether patents should be obtainable for different subject matter (Macer, 1992a, 1992b). 90-94% of all groups agreed with the patenting of inventions in general, such as consumer products. There was less consensus on the patenting of other items, though the same relative order of items was followed in all groups in Japan and New Zealand. There was less acceptance of patenting new plant or animal varieties than of inventions in general. Only 51% of the public agreed with patenting of "genetic material extracted from plants and animals" in New Zealand, but even less, 38%, in Japan. There was even lower acceptance of patenting "genetic material extracted from humans", in Japan only 29% of the public agreed, while 34% disagreed. In all groups more people disagreed with the patenting of genetic material extracted from humans than those who agreed with it. Among scientists however, company scientists were much more supportive of patents then government scientists, as can be seen in Table 6.


Table 6: Attitudes towards patenting by company, government and university scientists in Japan.

Respondents were asked the question, "In your opinion, for which of the following should people be able to obtain patents and copyright?", Responses: Yes= approve, No= disapprove, DN= don't know (from Macer, 1992a).

Company
Government
University
Total
Item
Yes
No
DN
Yes
No
DN
Yes
No
DN
Yes
No
DN
Inventions 972 193 34 924 494 33
Books80 137 839 883 116 8211 7
Plants88 57 768 1471 1118 788 14
Animals84 79 7311 1667 1221 7410 16
Plant & Animal genetic material 6221 1735 3035 4531 2446 2826
Human genetic

material

5232 1624 4135 3437 2935 3728
7.2 Global issues of technology transfer

When organisms whose genes are being used are derived from one country, which may be a developing country, and the research is conducted in another country, usually an industrialised country, because of its economic advantage it can support much more research, and a patent may be applied for by the researchers who by virtue of their money could invest time into sequencing a gene associated with a useful property. In 1992 a Biodiversity Treaty was signed by most countries of the world at the World Environment and Development Summit in Rio de Janiero, which would offer some protection to developing countries against such opportunistic investment. They may argue that already the rich countries are gaining much advantage from free transfer of agricultural crops that originated in developing countries, developed by old biotechnology, so the developing countries should be able to at least share equally, or even gain some compensation, for future uses of genetic resources by rich countries who apply new biotechnology. The question is whether old biotechnology is so different from new biotechnology, and what is justice. We can only expect this conflict to continue, as the biodiversity treaty is applied to patent policy and law, and depending on its acceptance by the USA.

There is still no reward given to the farmers who for millenia 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 Organisation conference, representatives from 156 countries recognised that "plant resources were part of the common heritage of mankind and should be respected without any restriction" (Juma, 1989). Since then an international network of gene banks has begun to be established, who will provide genetic material worldwide. These also preserve genetic material from species that are becoming extinct because of environmental destruction.

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 (in their regional versions of this declaration, Sieghart, 1985). 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.

7.3 Short-term versus long-term perspectives

Most businesses, and governments, are run on short-term windows, rather than long-term perspectives. Until long-term perspectives are adopted sustainable technology is likely to be considered too expensive to compete with short-term resources. We only need to think of the price of petroleum for energy use and transport to see a key example. Biomass-derived energy sources, which are based on renewable solar energy, may not be adopted until economically they can compete. Because pollution damage from petroleum emissions is not included into their cost analysis, they are seen as cheaper energy sources. There is thus an economic conflict, which prevents the rapid introduction of biotechnology-derived energy sources.

There has been much controversy regarding the use of recombinant bovine somatotropin (BST) to increase milk production in the dairy industry. The major concern is not the safety of the product (Kessler et al., 1992), though this continues to be questioned (Gershon, 1992), but the socio-economic impact on farming communities (OTA, 1991a). Although BST increases milk yield, it may aid the current trend for small dairy farmers to go out of business, and for larger farms, which are more economically efficient, to succeed. Here we have a short-term economic view versus a long-term perspective related to social issues or urbanisation, and secondary economic issues about the creation of new employment. This is not unique to agricultural biotechnology, and other factors such as nutrition of feed can alter milk production, but it is a question that requires a long-term perspective to answer in an ethical way.

7.4 Safety versus Costs

Such a heading may be provocative, but it is a real conflict. More time spent in testing the safety of a new drug or foodstuffs, or the environmental safety of a new organism, means more money is invested. Ethically, we may say do no harm has priority, and require long periods for testing of new products. However, this means that the average costs for development of new drugs are so large that only large companies can take a product through to the market, after safety approval.

Society allowing private industry appears to succeed better, as shown from the recent experiments with communism in the 20th century, so society wants to promote industry as a means to competitive and more efficient production of drugs or foods. It is to the benefit of society to support some industry, though they must be careful when giant monopolies are formed. Therefore there is a conflict between safety and development costs. This conflict lead to the use of special measures such as the Orphan Drug Act in the USA, which allows the earlier use of new drugs if there is a strong medical need, encouraging industry to spend time developing them.

Nevertheless, society does impose safety standards to protect human and environmental health. Another method of attempting to ensure safety is to allow liability suits in courts, which is an additional protection. However, there also needs to be limits on liability claims, otherwise research into such areas as contraceptives, or vaccines, may be inhibited, due to company fears of future litigation for unrealistic monetary sums in such sensitive areas.

In early 1991 the US government attempted to restrict regulations on biotechnology products (PCC, 1991), such as foodstuffs, as an incentive to encourage further industrial investment. We will not know whether this compromised human or environmental health until the future if mishaps occur. Large industry may be cautious about liability suits, and better ensure safety of products, but it has been suggested that allowing industry the option of not asking for independent review of product safety, risks exposing the public to untested products marketed by small companies trying to make a quick profit.

7.5 Is new technology better?

Companies naturally have a desire to recover development costs of new products, so they will attempt to market their products once they are approved. There has been recent controversy over the use of several products of genetic engineering in microorganisms that are examples of the type of ethical conflict that can arise if these products may not be the most clinically suitable or cheapest.

Recombinant human insulin has been associated with unawareness of hypoglycaemia, unlike porcine insulin, and there are growing calls to examine its effects (Egger et al., 1992). Human insulin was speedily adopted in most countries of the world as a replacement for porcine insulin, a decade ago, when new data comes to hand regarding adverse effects we need to reexamine its use. An example involving much more economic interest regards the reported lower effectiveness of tissue plasminogen activator (TPA) in some medical applications compared to streptokinase (ISIS-3, 1992). TPA is much more expensive than TPA, so that even if there effectiveness is equal we should use the cheaper product, according to just distribution of health care money. However, commercial interests want TPA to succeed. One can even see the infamous case of the apparent French delay in use of HIV-tests until a French-produced kit was available, to protect national industrial interests (Anderson, 1992a). Another area of economic benefit to pharmaceutical companies is development of new broad-spectrum antibiotics, yet these can be linked to increasing health problems caused by antibiotic-resistant microorganisms (Neu, 1992).

There are clearly many conflicts raised by commercial interests and marketing. Ethical biotechnology is often under challenge, and will be subordinate to commercial biotechnology interests. There may even be unethical calls for patronage of research areas made by scientists who want to develop new technology, when older techniques are available, as in the case of calls for a malaria vaccine versus use of the money in vector control (Gajdusek, 1992). The public may sustain this by belief that new technology is better - it is not always.

8. Resolution of Conflicts

8.1 Who can be trusted?

Scientists will win more public support for research by involving the public in decision-making, and being open. If it is ethical biotechnology than the public may, by a large majority support, such an application. The public has a high level of suspicion of safety statements made by scientists, especially those involving commercial decisions. In surveys conducted in Japan (Macer, 1992a) and New Zealand (Couchman and Fink-Jensen, 1990), high school biology teachers and government scientists were even more suspicious than the public, when asked the following questions:

Q16. To what extent do you agree or disagree with the following statements that other people have made?
1 strongly disagree 2 disagree 3 neither agree nor disagree 4 agree 5 agree strongly
b. If a scientist working in a government department made a statement about the safety of a research project, I would believe it.
c. I would usually believe statements made by a company about the safety of a new product it had released.
d. The activities of scientists in Japan should be more closely regulated to protect public safety.

In Q16b, 35% of the public said that they would believe a statement made by a scientist working in a government department about product safety, and 21% said that they would not, and 44% said that they would not be sure (Figure 5). Q16c asked about the credibility of company statements about product safety, and there was less trust of such statements, with 17% of the public saying that they would believe such statements and a greater proportion, 36% saying that they would not believe it, and half, 46% said that they would neither agree or disagree.

The responses to Q16c clearly show how company safety statements are not trusted by people, even by company scientists. Only 12% of scientists said that they would usually believe a statement made by a company about the safety of a product it had released. Only 6% of government scientists would usually believe company safety statements, but 24% of company scientists said they would believe them, whereas 26% of government scientists, and 35% of company scientists, said they would believe safety statements by government scientists (Macer, 1992a). In the USA, people were also asked whether they would believe statements made about the risks of products by different groups (OTA, 1987), and companies were less trusted than government agencies, with university scientists being the most trusted. Only 6% said that they would definitely believe a statement made by a company about its product, and 15% said they would not believe, with 37% inclined not to believe and 39% inclined to believe.

Committee meetings involved in the regulation of biotechnology and genetic engineering should be open to the public. Such open decision-making would gain more public support then closed meetings, and openness would improve public confidence in regulators. It may also result in better safety than regulations which put industry on the defensive and result in closed-door discussions. Moreover, an open approach may be better at winning public support than the current approach of spending money on advertisement campaigns that could be seen as pro-biotechnology "propaganda" campaigns. Most people are already aware of the benefits of biotechnology, but they will remain concerned about decision-making that is hidden.

8.2 Provision of information may obtain higher public approval

There was higher support for specific applications of genetic engineering than there was for general research, suggesting that the public will better support worthy applications of technology if they are told the details of them. In the results of the opinion surveys conducted in Japan (Macer, 1992a), and USA (OTA, 1987) higher acceptance with biotechnological techniques was found when specific information was given.

When people were asked whether they would use gene therapy to cure serious genetic diseases, the majority do accept the use of human genetic manipulation for curing serious genetic diseases (Macer, 1992c), as in the USA (OTA, 1987). Q7 was a general question and was expected to show lower approval of genetic manipulation on humans than the specific questions (Table 2).

A similar effect was seen regarding the approval for environmental release of GMOs in Japan (Macer, 1992a), and in the USA (OTA, 1987).

Q19. If there was no direct risk to humans and only very remote risks to the environment, would you approve or disapprove of the environmental use of genetically engineered organisms designed to produce...?
1 Approve 2 Disapprove 3 Don't know
Frost resistant crops
More effective pesticides
Bacteria to clean up oil spills
Disease resistant crops
Larger game fish

The results are shown in Figure 6. There was clear approval for environmental release of disease or frost resistant crops, with less approval for bacteria to help fight oil spills. There was lower acceptance of developing better pesticides, though still a majority of all groups supported this. There was rejection of the idea of making big game fish in Japan, and this was the largest difference to the results obtained in the USA. These survey results are a clear mandate for further research to develop some products involving GMOs, and to have further field releases of new varieties of plants to test their performance, prior to farmer's use. They also clearly illustrate that the public can differentiate their support depending on the perceived benefits or risks, and the information they receive.

8.3 Public education not propaganda

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 (BMA, 1992). Some US companies have also had large public relations campaigns, such as Monsanto. Recently, following a survey of scientists in the USA engaged in recombinant DNA research, which found that more saw public attention on genetic engineering research as beneficial than harmful to their research, public education programs to stress the benefits of biotechnology have been called for (Rabino, 1991), though some are under way already in the USA.

The results of the surveys described in Macer (1992a) questions the effectiveness of such programs, and also whether their goal is desirable. 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 (see Chapter 14).

8.4 Sufficient regulations

8.4.1 Regulation of environmental risk

Regulations for the environmental release of GMOs have been enacted in many countries of the world (see Chapters 1, 2 and 5), some being statutory and others guidelines. The European Parliament set minimum legal standards for European Community countries, though regulations vary between strict, as in Germany, to non-existent in other countries - which rely on the default European regulations. In the USA a variety of agencies have taken responsibility for different areas of biotechnology applications, and the guidelines are evolving into product-based regulations with exemptions (OTA, 1991c). The USDA has approved many releases of GMOs (see Chapter 5). In Japan, each of the major ministries have their own regulations, and there has been only one field release of a GMO (Macer, 1992a).

Islands may develop particularly different regulations and enforce them, but regions, such as Europe, need common minimum regulations, as neighbouring countries are at risk. Conversely, any country which imposes extra regulations must suffer the lower industrial development of their neighbours, without a significant reduction in risk.

We must also gather information from past releases of new organisms and their ecological consequences. We can hope that the information is shared globally, to avoid others making the same mistakes, and to ensure all countries have a similar minimum standard of protection. It is clear that the authorities and committees that have the most experience with releases should have developed the most skill in assessing the ecological risk. Review should of course be independent, to avoid conflict of interest.

There may be beneficial environmental consequences of biotechnology, as discussed in Sec. 4.3. It may reduce the use of chemical pesticides, as discussed in volume 11 of this series. There may also be less risk associated with using living organisms to produce raw materials for industries, such as the chemical industry (OTA, 199b). We only need to think of accidents like Bhopal in India, where a disaster was caused by dangerous chemical intermediates. Biotechnology using safer intermediates and raw materials may not only be more sustainable but also safer.

8.4.2 Product safety

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 standardised, 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.

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 (WHO, 1991). 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 Japanese Ministry of Health and Welfare has published bilingual guidelines for foods and food additives produced by recombinant DNA techniques (MHW, 1992). They exclude 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 key question is whether they decide the foods are novel or not, because if they are novel, extensive safety tests must be performed. The guidelines state "the novelty depends upon comparison of identity and promotion of product with existing foods or food additives". The test of the guidelines will be how the committee works, whether they make their proceedings public, and where it draws the line of novelty. It is certainly safer to force a committee examination, than to exempt that as has been adopted in the USA.

8.5 Public involvement in regulatory processes

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 (see Sec. 8.1). In some countries hearings are conducted in public, as in the RAC committee hearings on human gene therapy in the USA. This may have lowered public concern in a controversial area, though companies do not require RAC approval, only FDA review which is private (Anderson, 1992b). In other countries there is almost no openness to the public, as in Japan.

In the above-mentioned survey responses (Macer, 1992a), the public, high school biology teachers and academics gave very similar depth of responses to many questions, suggesting 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.

9 Ethical limits of biotechnology

9.1 Absolute or relative?

We can ask whether there should be an absolute ban on certain applications, such as sex selection, or germ-line gene therapy. Such bans are only justified when their is a clear risk of social harm. There are other areas of biotechnology where there clearly should not be an absolute ban, as in the use of genetic engineering on any organism. There are some conditional bans imposed, such as the guidelines to protect human subjects from unconsented experimentation or dangerous experimentation. Some would call for a ban on experimentation using animals, and the proportion supporting such a ban on primates is significant. Laws may be introduced to impose absolute or conditional bans on some research, and this is needed, at least in some areas. Everyone is subject to laws, and scientists should not expect to be exempt. Laws, as said above may not always be ethical, they may be relative, as public opinion is not always reflecting an ethical view - and there may not even be an absolute ethically correct answer.

Is there a clear distinction between disease and non-disease, which may determine whether prenatal genetic screening and selective abortion is ethical or not? At the extremes there is, but there are grey areas in the middle, and we must ask how to regulate this - do we impose absolute limits, or do we take up the principle of autonomy and allow women to decide what is a disease or not. The ideal would be to allow women a completely free choice in the adoption of the disease-markers they want to use, and that they would responsibly do this. However, abuses may occur, sometimes due to social forces upon the women - such as a medical insurance companies refusal to provide medical care to children suffering from disease who had a "preventable birth". Such a discussion will be shocking to some people, but in other cultures a majority may be more pragmatic, and it would not be seen as immoral. Can we have absolute limits?

Another example is whether we should have absolute exclusions on subject matter for patents. Should we make exceptions in areas of important benefit, or to encourage beneficial research that would not otherwise be performed. The answer is there may be exceptions, and a response to the demand for flexibility is the use of independent committees for decision-making.

9.2 Timeless or transient?

As discussed above in Sec. 6, there will be future conflicts in determining what is ethical biotechnology. Our concepts will change, and there is no guarantee that unethical applications will be made, and even supported, by future public majorities. We need to remember history, and also may need to introduce some international laws which make it more difficult for future unethical uses to occur. However, we need to be flexible, as we gather experience we may need less stringent regulations, as in the case of release of GMOs or gene therapy.

Biotechnology has had a positive effect on the debate of bioethics, and we must ensure that the debate matures and is applied more widely to other technologies, old and new. The introduction of new techniques may even be necessary to change general patterns of ethical and social thinking, for example, the introduction of nondirective genetic counseling that is associated with genetic screening could hasten the introduction of the concept of informed consent into general medical practice.

9.3 Scientific responsibility for ethical applications

Scientists are called upon to take responsibility for the social consequences of their research. Recently we can see the growth of ELSI (ethical, legal and social impact) grants from human genome research programs, so that the NIH in the USA is spending over 5% of the human genome project grants on ELSI issue research. We can also see the emergence of movements such as the Universal Movement for Scientific Responsibility (MURS). MURS is attempting to introduce articles into the UN Charter of Human Rights (Melancon, 1992), and such moves represent important steps in the growing maturity of scientists. These may illustrate a paradigm shift among scientists to concentrate more attention on the social impacts of their research, especially in areas such as biotechnology and genetics.

10. Criteria to assess whether biotechnology research is ethical

We can think of some summary criteria which may be useful in determining whether any given application of biotechnology is ethical. Although it is possible to develop useful numerical scoring systems, as has been attempted for animal experiments (Porter, 1992), they are still only guides and may be more useful in directing attention to the better and more ethical design of experiments. Therefore only some criteria important to assess the ethicity of an experiment or application are given below:

1. What is the benefit? To whom? Is it life-saving? Human benefit is greater than monetary benefit.

2. Do no harm to humans. What is an acceptable level of risk? Follow ethical codes on free and informed consent for human experimentation.

3. Do not cause pain. Protect animal rights as much as possible, use less sentient animals for research, and develop non-animal alternatives.

4. Do no harm to the environment. Use the technology that is most environmentally sustainable over the long-term. Minimise consumption, may need to introduce environmental quotas to do this according to just distribution of global assets and introduce maximum levels for individual production of pollution.

5. Protect biodiversity. Protect endangered species. Allow farmers affordable or free access to breeding stock, and encourage planting of diverse crops.

6. Justice to all people, and future generations. Share benefits and risks.

7. Independent open decision-making on safety questions, consider ethical and social impact.

8. Inform and educate the public and scientists about all dimensions of the projects, scientific, social, economic and ethical, using third party media.

11. Conclusion

We need to understand that perceptions of the impacts of technology are more complex than simple perception of benefit or risk, as they should be. The capacity to balance benefit and risk of alternative technologies, while respecting human autonomy and justice and the environment, while simultaneously being under the continual influence of commercial advertisements and media stories of varying quality and persuasion, may prove to be an important indicator of the social and bioethical maturity of a society. In addition, to develop the bioethical maturity of society, global human rights need to be increasingly respected so that we get social progress as well as scientific progress. All people should equally share both the benefits of new technology and the risks of its development.


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Figures are not on-line. Copyright VCH Inc., Germany (reprints available from author). See reference Macer, D.R.J. (1992). Attitudes to Genetic Engineering: International and Japanese Comparisons. (Christchurch: Eubios Ethics Institute).

Figure 1: Comparative perceptions of science developments between Japan and New Zealand

The results are based on the number of respondents who said that they had heard of each development (Q5a), and are presented as scattergrams, with number of respondents who thought each development was worthwhile for their country versus the number of respondents who were worried about the impact of the developments. Results from Japan are from Macer (1992a), and New Zealand results are from the survey of Couchman & Fink-Jensen (1990).

Figure 2: Comparative public concern about the impact of developments in science and technology between Japan and New Zealand

The results are based on the number of respondents who said that they had heard of each development (Q5a), and the degree of worry about the impact of the developments (Q5d) is plotted. Results from Japan are from Macer (1992a), and New Zealand results are from the survey of Couchman & Fink-Jensen (1990).

Figure 3: Comparative perceptions of the benefits and risks of genetic manipulation in Japan and New Zealand by public and scientists.

Results from Japan are from Q7 of Macer (1992a), and New Zealand results are from the survey of Couchman & Fink-Jensen (1990).

Figure 4: Perception of environmental benefits from applications of genetic engineering in agriculture in Japan and New Zealand.

Results from Japan are from Q16f of Macer (1992a), and New Zealand results are from the survey of Couchman & Fink-Jensen (1990).

Figure 5: Comparative attitudes towards scientists in Japan and New Zealand.

Results from Japan are from Q16b,c,d of Macer (1992a), and New Zealand results are from the survey of Couchman & Fink-Jensen (1990).

Figure 6: Attitudes to environmental release of GMOs in Japan and the USA.

Results from Japan are from Q19 of Macer (1992a), and USA results are from the OTA (1987) survey.


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