General Ethical Concerns, and Environmental and Regulatory Issues


pp. 58-81 in Impacts of Biotechnology in Agriculture and Food in Developing Countries (International Council of Scientific Unions, COSTED: 1992).
Author: Darryl R. J. Macer
This paper is divided into several sections. First bioethics is introduced, then some results of public perception of biotechnology and genetic engineering are presented, and the implications of these results are discussed and conclusions are made.

Bioethics

Bioethics is the study of human conduct in the area of life sciences and health care. It considers moral values and principles. Ethical issues arise when there are different choices of behaviour or activity possible. Any moral choice involves ethical decision making. Those type of decisions are ones that everyone makes, though many may ignore the alternative actions. There are large and small problems in ethics. We can think of problems that involve the whole world, and problems which involve a single person. We could think that global problems such as global warming and ozone depletion may overshadow all others. This problem however, can only be solved by individual action, to reduce energy use.

Scientific activity involves decision-making. Scientific knowledge itself is morally neutral. Do not confuse scientific activity with scientific knowledge. Scientific activity is not unique it is like any other human activity, and raises ethical questions. This is especially true of applied science, like biotechnology.

There are some key principles of ethics which are briefly outlined below, and we should balance the implications that arise from each principle to arrive at more ethical decisions (Macer 1990). The basic ethical principles to be balanced are:

Autonomy: a right for self-thinking beings to make their own decisions, and not to be harmed by others. (From this we derive: Human rights, Animal rights)

Beneficence: Attempt to do good (From this we derive: Progress of useful technology is good, research for useful goals is good)

Do no harm: Try not to do harm (From this we derive: Safety considerations, environmental protection)

Justice: Protect the autonomy of any organism which possesses autonomy

(From this we derive: Just distribution of benefits and risks, law)

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 go for a walk, to talk to people, to read a book, or to listen to the radio. These are all personal choices. We may be put under some pressure by the people around us to engage ourselves in a particular activity, or to behave in a certain way, but ultimately it is our choice. In a democratic society we recognise that we have a duty to let people make their own choices. This is also expressed in the language of rights, by recognising the right of individuals to make choices. Respect for the autonomy of individuals is the fundamental principle of bioethics.

Rights give us dignity and protection. If we have a right to something we can insist on it without embarrassment or fear, though to challenge those in authority in many countries can result in fear. 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. 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 a partnership. The recognition of human rights has changed the shape of many countries, and many countries in the world have signed the UN Declaration of Human Rights (Sieghart 1985), or one of the regional versions of this. It includes a right to share in the benefits arising from scientific advances, and a right to a reasonable future.

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. Environmental damage can not be compensated by monetary reimbursement. The solution is to have more moral companies and politicians, and the replacement of money by ethics, as the primary motive of decision-making.

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 the people's best interests, is taken to be a form of doing harm, a sin of omission. This is the principle of beneficence. This is a powerful impetus for further research into ways of improving health and agriculture.

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. We will look at how people weigh benefits of technology against the risks later.

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. This balancing is very relevant to areas of science and technology, where we can expect benefits and risks. Risk is the possibility of causing harm. There are different types of risk; some are low chance, but serious, events and others are high chance (occurring at a higher frequency) but may have minor consequences.

This 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. The reason we do no harm is because we respect human life. This feature is found in the Hippocratic tradition and all other traditions of medical ethics. It is also found in ethics in general. To do no harm is expressed more at an individual level, whereas justice is the expression of this concept at a societal and global level.

Justice

Those who claim that individual autonomy comes above societal interests need to remember that at major part of protecting society is because it involves many human lives, which must be respected. Individual freedom is limited by respect for the autonomy of other individuals in the society and the world. People's well-being should be promoted, and their values and choice respected, but equally, which places limits on the pursuit of individual autonomy. It also places limits on the autonomy of individual countries in the global community. We also need to consider interests of future generations which places limits on this generation's autonomy.

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, this is 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.

Universal Principles

We may try to make as many people as happy as possible, and have the greatest total benefit possible, while considering risks, justice and personal autonomy. Bioethics attempts to appeal to universally acceptable philosophical principles. These principles are found common to many religions, in addition to philosophy. We also need to respecting local religious views, in so far that they do not contradict the important common ethical principles that have just been described. There are other important issues to consider:

Confidentiality

A feature of the ethical use of new genetics, especially as biotechnology applies to humans, is the privacy of genetic information. It is not only because of respect for peoples autonomy, if that is not enough. It is also needed to retain trust with people. If we break a person's confidences, than we can not be trusted. It applies to all aspects of life. We need to protect individuals from discrimination that may come in an imperfect world, one that does not hold justice as its pinacle.

An extension of confidentiality is privacy, the right to refuse questions. If medical insurance companies try to take only low risk clients by presreening the applicants, there should be the right to refuse such questions. The only way to ensure proper and just health care is to enforce this on insurance companies, or what is a better solution, a national health care system allowing all access to free medical treatment.

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

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 is also human benefits that extend from products we find in nature, from various species, 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 that will upset this balance is another key issue raised by genetic engineering. We have been using agricultural selection for 10,000 years, so the introduction and selection of improved and useful plants and animals is nothing new! We should however, understand the impact of agricultural practices on the local and global ecosystems.

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, that we should not damage other species, unless it is absolutely necessary for the survival of human beings (not just for human luxury), because it is there. Nature has life, thus it has some value. Living creatures may possess some limited "right" to live, because they possess life. It is very difficult to define, and when we consider human survival we believe human rights are greater, but we do recognise it. It is also found in many religions. This applies to individuals and species. 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.

Animal Rights

Some animals have additional characters beyond plants which are ethically important. The issue of the use of animals in research has been a very controversial issue in some countries. 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.

The moral status of animals, and decisions about whether it is ethical for humans to use them, depends on several key attributes; the ability to think, the ability to be aware of other family members, the ability to feel pain (at different levels), and the state of being alive. 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 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 experiment, or for food production (which is by far the greatest use of animals). Additionally, as all will recognise, inflicting pain is bad (Singer 1976), so if we do use animals we should avoid pain. 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. This reasoning, is also reflected in public opinion presented later.

Decision-making

To anyone who starts to try to use these principles in their daily life, it will very soon be apparent that there needs to be a balancing of conflicting principles of ethics. Different people's interests will conflict, how do we balance protecting one person's autonomy with the principle of justice, that is protecting all people's autonomy. 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 people's interests and preferences.

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, they have to. The benefits are great, but there are many possible risks. Although our life may have become easy, so that we avoid making very many decisions, we must. The more possibilities that we have, the more decisions that we make. Fortunately standards of education are increasing, but this is no guarantee that the right decisions will be made. People need to be taught more on how to make decisions, and the education system should accommodate this need of modern life.

Public Opinion about Genetic Engineering

It is now time to look at what people say about biotechnology and genetic engineering. It is important to look at what people really think about these issues, and also to see how they think. The application of both techniques will provide many benefits, but there are also many associated 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 will affect the lives of people throughout the world. 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. 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!

The following survey results were obtained from surveys in Japan, that I performed (Macer 1992), and in New Zealand (Couchman & Fink-Jensen 1990), with some in the USA (OTA 1987). There is an absence of data from developing countries, because such surveys have not been performed there. It is hoped that in the future similar questions may be asked in many countries. The statistical results do depend on the education of people and what media information they have been exposed too. But an important part of the recent survey was that for key questions about genetic manipulation, open responses were requested. From these responses the reasoning behind the results can be determined (see Macer 1992). It was found that the reasoning in Japan was very similar to the reasoning in New Zealand, two countries with many cultural differences. It will be useful to know how people think in many countries, and we may find that all people share basically similar thinking patterns. If this is true, it would make the case much stronger for common international guidelines in bioethics, and in decisions associated with the impact of biotechnology.

Perceptions of Science and Technology

Figure 1: Benefit versus Concern

People were asked whether they had heard of each of a list of eight developments in science and technology. The people who had heard of each development were then asked whether they thought research in each area was worthwhile in their country, and whether they were worried about the impact of each development to their country. The comparative results are shown in Figure 1.

Genetic engineering is of high concern, as is pesticides. Biotechnology is of lower concern, as is biological pest control. Biological pest control is considered very worthwhile in New Zealand, which is an agricultural country, and where it is already being well used. Human in vitro fertilisation (IVF) is of high concern in Japan, but of lower concern in New Zealand. The three developments of physics, fibre optics, silicon chips, and superconductors are of low concern in both countries. The results from surveys of the opinions of scientists and high school biology teachers were generally similar.

Figure 2: Degree of concern

The degree of concern that people had was also asked, and this is shown in Figure 2. The question was, "for each development of science and technology where you are worried; please indicated how worried you are about the impacts of each development?" The extra level of concern expressed in Japan was of the "extremely concerned" type, with similar levels of people who answered that they were "slightly", "somewhat" or "very" worried. Genetic engineering is an area of high concern, there was somewhat less concern with biotechnology, especially in New Zealand.

Genetic Manipulation

Next, people were asked more specific questions about genetic manipulation of human cells, plants, microbes and animals. They were asked whether they thought genetic method using each of these four organisms or cell types was acceptable. The results are shown in Figure 3. (The number of respondents to the questions in general are indicated in Figure 6, for full information on the sampling methods which used mail response see Macer (1992)).

The results indicate that plant genetic manipulation is the most acceptable type, by all groups. It has a high level of acceptance. The next most acceptable is genetic manipulation of microbes, followed by that of animals. This is less acceptability of using human cells, though in more specific questions not shown in this paper, people were supportive of human gene therapy for curing serious diseases of themselves or their children. The reasons that people cited for unacceptibility were similar between all groups, with reasons including the techniques were unethical, interfering with nature, profanity to God, likely to lead to disaster, unknown result, ecological and environmental harms, fear of human misuse, insuffcient controls and various other lower frequency reasons.

Figure 3: % of respondents who thought that genetic manipulation was acceptable.

People were also asked whether they though genetic manipulation had benefits or risks, and the results are shown in Figure 4. The New Zealand data are from Couchman & Fink-Jensen (1990), the Japanese results from Macer (1992), as for all these figures.

People see both benefits and risks from genetic manipulation of all organisms. The responses of the public are generally very similar to those of the scientists surveyed. The reasoning behind these responses were also asked, and these were found to be very similar between all groups. People perceive many medical benefits from genetic manipulation of humans and microbes, and agricultural benefits from plant and animal genetic manipulation. Relatively few respondents cited environmental benefits, even though many agreed with a specific question that use of plants made using genetic engineering will reduce the use of chemical pesticides and be an environmental benefit. The major risks, and reasons for unacceptibility were that the techniques are perceived to be unethical, interfering with nature, playing God, or to be associated with unknown results and possible ecological and environmental harm, or human health hazards (Macer 1992). There is also concern about regulations and human misuse.

Figure 4: % of respondents who thought that genetic manipulation was associated with benefits and risks.

Environmental Release of Genetically Modified Organisms

People were also asked "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...?".

This is a question asked in the USA in November 1986 (OTA 1987), so comparisons can be made. The results are shown in Figure 5. There was clear support for the release of disease resistant or frost resistant crops. There was rejection in Japan of the use of genetic engineering to make big game fish, an example of enhancement engineering. People will support applications that are needed, but may not support applications that are not seen to be worthwhile, or which may be seen to interfere with nature too much.

Figure 5a: Public opinion Figure 5b: Approval by groups in Japan

Consumption of products made from genetically modified organisms

Another question is whether people are happy to eat foodstuffs made from varieties bred using genetic engineering. People were "If any of the following were to be produced from genetically modified organisms, would you have any concerns about using them?". The results are in Figure 6. There was least concern with the consumption of vegetables, and most concern with consumption of meat. The reasons for their concern were also asked, the most commonly cited reasons were unknown human health effects that could be longterm, and the adequacy of safety standards. People also wanted the information to be made public.

Figure 6: Concerns about consuming food from genetically modified organisms.

Economic issues

Another very topical issue is the question of patenting. People were asked "In your opinion, for which of the following should people be able to obtain patents and copyright?". The results are shown in Figure 7. There was rejection of the idea of patenting of human genetic material, though many people in Japan were unsure of their opinion. There was also considerable doubt expressed over the patenting of genetic material from plants and animals, and new plant or animal varieties. This is a very topical issue, given recent moves to attempt to patent large numbers of human genes in the USA (Patents 1991). Public opinion needs to be included in the discussion of this issue, in addition to other concerns (Macer 1992). We may need to have some type of intellectual property rights protection to encourage technology transfer (Lesser 1991), but it must be just. The common property of humanity should not be able to be exploited by individuals who have the money to sequence the genes (Macer 1991). We should only reward researchers who make genuine novel research with useful applications.

The views of scientists and the public in Japan were very similar to each other (Figure 7a). The results from the three different groups in Japan and New Zealand are shown in Figure 7b.

Figure 7a: Attitudes to patenting of different subject matter.

Figure 7b: Approval of patenting of different subject matter

Environment versus Economics

There will always be a conflict between economic priorities and environmental protection. This is also true in commercial uses of biotechnology in the environment. One way to include some concern for the environment is to impose severe financial penalties on companies for environmental harm, but we need to persuade companies to protect the environment because of its value of existence itself as said in the introduction to environmental ethics.

There have been some surveys on the balance between economics and the environment. In one question asked in March 1989 in several industrialised countries, people were asked whether they thought the development of economics or the protection of the environment and nature should be the first priority. The results are shown in Figure 8. More people saw environmental protection as a first priority, though many added the qualification that we need to consider economic development (Environment first, but...). This is the responses to the question, it does not mean that this represents the situation in practise in those countries or especially in their foreign policies!

Figure 8:

Regulation of genetic engineering and biotechnology

Some key features can be found in many regulations. There are several areas that need regulation. Food safety was briefly discussed above. We also need regulations to monitor the safe development of genetic engineering in laboratories, factories, and in environmental releases. Laboratory research guidelines have been worked out, and present little difficulty because of the small volumes involved. It may be important for people to maintain a high level of care, as any possible risk probably involves only human error.

Fermentation of genetically modified bacteria, and yeast, and large scale growth of plant and animal cells, requires care in the disposal of wastes. The production of products for consumption requires purification and monitoring the same as any other process.

The release of GMOs to the environment is the area with the most concern. The regulations in Europe are still being implemented, but general minimum standards have been set. International regulations are being revised, and international advice is available to countries without resources to perform details studies themselves. It is important that international standards are applied, as the environment and ecosystem sees no national boundaries. The risks include the risk of ecological displacement of species, of gene transfer to wild species, and other ecological effects. There is very little risk to human health, though vaccine trials need to be monitored.

Some common features of international regulations include:

1) view only the product, not the method of manufacture. If a new variety is made, we should not impose special restrictions depending on its method of manufacture. In fact, we may have more precise details of the gene structure of varieties made using genetic engineering than when using other methods.

2) Case-by-case assessment is needed, using some system of balancing ecological risks

3) Public should be notified, and be able to submit comments

4) Some countries make exemptions for certain categories, and modify the definition of what a genetically modified organism is. It may be best not to have any exemptions, but for a general screening committee to decide what information must be provided for each case.

5) It is more consistent to use a single regulatory body in each country, rather than multiple committees. Rather than having multiple tiers of control, such as federal, state, and local regulations, a single expert committee should receive imput from local residents and other groups.

The types of features which are included in applications for release include the personnel involved, objectives of the release, location, descriptions of the organism/gene/vector (including ecology and molecular biology), description of production process, arrangements for release, potential environmental effects, monitoring arrangements, contingency plans for unexpected events, method of cleaning the test site after the trial, and the results of prior assessment (OTA 1988, Tiedje et al. 1989, UK 1991). We can also add the results of other researcher's experiments, because there have been about 400 field releases around the world now, and there is a large body of results accumulating which can be used to ease the assessment of similar future applications.

Commercial releases are beginning to occur, and we can expect rapid introduction of genetically engineered plants and biopesticide products. Education of farmers is very important, and must be increased. The problems of insect resistant plants will be the development of resistance to the insecticidal gene products, so sound ecological management is required. It is a duty of the developers of these techniques to follow the development through to careful practical use. They should also encourage the adoption of environmentally sustainable and safe applications of biotechnology.

Conclusions

Scientists need to be ethical in their approach to their research and applying their work. They must also make moves to encourage the users of the technology to be ethical in their utilization of research.

Scientists share similar concerns to the public, and they should attempt to understand these concerns. Some can be eased by better information on the ecological impact of new organisms and varieties, and by the establishment of sufficient safeguards. Other concerns, such as ethical reasons or when techniques are seen as interfering with nature, may not be removed. It was very important to find that scientists in Japan share these concerns. Further research is required to see how universal people's attitudes are.

The regulation of GMOs was briefly discussed, for detailed references of these topics see two recent books, Macer (1990, 1992), and additionally an ongoing newsletter (EEIN) up-dates the references related to this field. We must work towards minimising the adverse impacts of biotechnology, and yet also ensure that it has a useful impact on all peoples of the world.


References

Couchman, Paul K. & Fink-Jensen, Kenneth. Public Attitudes to Genetic Engineering in New Zealand, DSIR Crop Research Report 138. (Christchurch: Department of Scientific and Industrial Research, Crop Research Division, Private Bag, Christchurch, New Zealand 1990).
Lesser, William H. Equitable Patent Protection in the Developing World: Issues and Approaches (Christchurch: Eubios Ethics Institute 1991).
Macer, Darryl R.J. Shaping Genes: Ethics, Law and Science of Using Genetic Technology in Medicine and Agriculture (Christchurch: Eubios Ethics Institute 1990).
Macer, Darryl (1991) "Whose genome project?", Bioethics 5: 183-211.
Macer, Darryl R.J. Attitudes to Genetic Engineering: Japanese and International Comparisons (Christchurch: Eubios Ethics Institute 1992).
Patents (1991) Science 254: 184-6; Nature 354: 171-2, 174.
Rachels, James Created from Animals (Oxford University Press 1990).
Sieghart, Paul The Lawful Rights of Mankind (Oxford: Oxford University Press 1985).
Singer, Peter Animal Liberation (London: Jonathan Cape 1976).
OTA (1987) U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology, 2: Public Perceptions of Biotechnology - Background Paper (OTA-BP-BA-350, Washington D.C.: U.S.G.P.O. May 1987).
OTA (1988) U.S. Congress Office of Technology Assessment, New Developments in Biotechnology, 3: Field Testing Engineered Organism, Genetic and Ecological Issues, (Washington: U.S.G.P.O., OTA-BA-350, May 1988).
Tiedje, James M. et al. (1989) "The planned introduction of genetically engineered organisms: ecological considerations and recommendations," Ecology 70: 298-315.
UK Royal Commission on Environmental Pollution, Fourteenth Report, GENHAZ, A System for the critical appraisal of proposals to release genetically modified organisms into the environment (London : HMSO June 1991).
WHO (1991) Report of a joint FAO/WHO Consultation, Strategies for assessing the safety of foods produced by biotechnology (Geneva: WHO 1991).


Some tables and figures can be found in: Macer, D.R.J. Attitudes to Genetic Engineering: Japanese and International Comparisons (Christchurch: Eubios Ethics Institute 1992).

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

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