Trends in biotechnology, Nr.18 1/00, John C. Polkinghorne, page 8

Ethical issues in biotechnology

New ethical questions have arisen from our ability to intervene in the structure of the genome. Responsible use of this technique requires ethical evaluation in which experts, potential beneficiaries and the general public should all participate. The examples of genetically modified food and of human genetics help to illustrate the issues involved.

From the time when the earliest pioneers of medicine took the Hippocratic oath, the importance of ethical considerations in relation to actions affecting living entities has been recognized by professionals. The general principles are still of fundamental importance: respect for life and the need for a balance of benefit over harm resulting from any intervention.

Contemporary features
There are three particular contemporary features that account for the heightened public concern on the threshold of the 21st century. First, much of the current development in biotechnology results from a greatly enhanced understanding of the nature of genetics and the consequent ability to perform manipulations in the genomes of plants and animals. This power to intervene in what might be thought of as 'the fabric of life' raises the question of whether or not this, in itself, is an ethically questionable activity.

Some feel that 'respect for life' implies that there should be no interference with it in this basic way. Conversely, the issue of the integrity of nature is itself complex and open to interpretation in an evolutionary world in which there is natural genomic plasticity. Moreover, the ethical does not simply equate with the natural. Heart transplants are as radically unnatural as gene transplants, but most people consider them to be ethically acceptable.

Second, the pace of discovery in genetics-based biotechnology is very rapid and there is anxiety that a kind of technological compulsion ('if we can do it, let's do it') will drive developments ahead of proper ethical consideration of their propriety. Not everything that can be done should be done but, once technology is 'on the shelf', it is hard not to take it off.

The moratorium on human germ-line therapy is an example of the recognition that there must be ethical restraints on the use of what is technically feasible. Part of the reason for this restriction is uncertainty about the long-term effects of such interventions. There is also considerable uncertainty about the environmental consequences of the genetic manipulation of plants. These issues are scientific questions that need to be answered before we have an adequate basis of knowledge for reaching final ethical decisions.

Third, advanced technology involves processes that are only well understood by the experts who develop and use them. This places considerable power in the hands of the companies that employ these experts. Currently, there is much public suspicion about the reliability and independence of this 'expert' advice. Some of this suspicion derives from a difficulty in understanding that absolutely certain answers often cannot be given to complex questions and that every element of risk can seldom be eliminated. It is also exacerbated by memories of unfortunate incidents, such as the bovine spongiform encephalopathy (BSE) crisis in the UK.

There is also much suspicion of transnational corporations, which are perceived by many as wanting to maximize their profits by making users dependent on their products and then controlling availability. The ethical use of biotechnology clearly includes it being provided on a fair and just basis, neither denying reasonable reward to those who have undertaken the considerable expense and risk of R&D nor putting small-scale users in thrall to large-scale suppliers.

Genetically modified foods
These general considerations can be illustrated by the current controversy about the development and use of genetically modified (GM) organisms in the food chain.

Selectivity
Selective breeding has been used since agriculture began, with the development of cultivated crops from wild species and of domestic herds from wild animals. However, it is now possible to carry out gene transfers that could not occur in nature, even gene transfers from the animal kingdom to the plant kingdom.

Some people have characterized this as 'playing God', with the implication that it is ethically unacceptable to interfere with nature. However, human beings are themselves part of nature and many religious people would see the responsible exercise of scientific skills as being the employment of God-given abilities. We have already seen that the natural-unnatural division is not in itself of intrinsic ethical significance, otherwise much of medicine, for instance, would be morally outlawed. Three particular points are notable.

• The genetic code is only significant when operating in the context of a living cell. In isolation, genes are simply complex chemicals. This has led some people to believe - to take the most ethically sensitive example - that if a human gene were transferred to a pig cell, it would, in that context, become simply a pig gene, although admittedly one of human origin. Other people do not accept this, but believe that the gene would continue to have the ethical status of a human gene¹.
  
• Current gene transfers involve single genes or, at most, small gene clusters. They represent a highly accurate and targeted form of crossing. The creation of chimeras with substantial interspecies mingling would raise different and difficult ethical issues, including questions of animal welfare.
  
• There is a widely recognized obligation to use this new technology for serious and valuable means, not for speculative or trivial purposes. Obvious examples of responsible projects to choose include the generation of therapeutic proteins from transgenic animals and the modification of crops so that they can grow in and or saline environments.

Environmental effects
One of the major concerns about GM crops is their possible environmental effects. Insect-resistant strains may reduce the use of insecticides, but will genes spread from herbicide-resistant strains to produce 'superweeds'? All interventions in nature run the risk of unanticipated upsets to its balance and, from the time that humans with stone axes began felling trees, agriculture has had significant environmental consequences. Even in the next millennium, our intellectual ability to foresee environmental effects is unlikely to be perfect. Some form of precautionary principle is ethically required, but it should not induce total paralysis. Because consequences are difficult to predict accurately, it is important that carefully controlled and monitored trials are used to gain the detailed knowledge on which ethically responsible decisions can be based.

Moral duties
It is predicted that the world population, currently approximately six billion, will rise to approximately eight billion by the year 2020. Present agricultural resources, if their produce was fairly distributed, could sustain approximately 6.4 billion people. Biotechnology offers considerable possibilities to help eliminate the anticipated shortfall. However, there is also considerable concern that small-scale farmers should not be exploited by large international companies.

Moral perplexities often arise when there is a clash between two different ethically desirable goals. The possible use of 'terminator' genes (that make seeds sterile) illustrates this point. On the one hand, they would help to reduce the hazards of environmental dispersal; on the other, farmers in developing countries traditionally save seed from one season to the next and cannot afford to buy new supplies each year. If these problems are to be solved, there must be recognition of the common good, understood on a world-wide basis and calling for fairness in the policies of big corporations and in the international regulation of biotechnological trading.

To these considerations must be added the universal ethical obligation to respect the duty of safety. With regard to food safety, GM products do not seem to raise issues or demand the monitoring of techniques, different to those employed to assess the effects of ordinary foods.

Human genetics
The use of biotechnology in relation to human beings is governed by the Hippocratic principle that interventions must be for the benefit of the individual person concerned. Controversy in this area is not generated by dissent from this principle but by disagreement about what constitutes a human person, with all the moral rights appertaining to that status.

Some believe that this status is established at the moment of conception. If that is the case then no manipulation of the early embryo, other than for its own direct benefit, could be ethically justified. Others, however, take a more developmental view of the way in which a human foetus grows into a person, with the dawning of sentience and eventually of mentality. This latter view forms the basis of the legal restriction in the UK on research using embryos to the 14-day period before the development of the primitive streak². Currently, that research is also limited to projects investigating aspects of human fertility. However, it has recently been suggested³ that the scope of possible investigation should be extended to include the use of cell-nuclear-replacement (CNR) techniques to generate immunologically compatible tissue for therapeutic purposes and for the treatment of mitochondrial disease. At present, there has been no decision by the UK Government on whether or not to accept this recommendation.

In the UK, GM embryos may not legally be implanted, so there is an absolute embargo on the use of CNR to generate cloned human beings. There is extensive ethical support for this legal position. The moral necessity to use new technology for acceptable means plays a determinative role in forming this view. Although the repair of damaged tissues in the ill or injured is seen as being highly desirable, the creation of a 'replacement person' is not so acceptable. Respect for the human person forbids this - not because there is an intrinsic human right to possess a unique genome (identical twins do not, but each is a human person) but because a human being is to be valued for their self and not used as a surrogate for another. The same moral intuition leads to an abhorrence of the idea of using genetic manipulation to produce 'designer babies' with qualities according to parental specification. Persons are never to be commodified: ethically, they are never means but always ends.

The example of the regulation of human genetics in the UK provides an answer to the so-called 'slippery slope' argument. It is sometimes argued that to allow CNR for therapeutic purposes would soon lead to it being used for reproductive purposes. The ban on exceeding the 14-day limit and on implanting GM embryos shows that there are effective barriers in place to prevent this happening.

Public debate
Debates on the ethical issues raised by biotechnology will certainly continue into the 21st century. Science, by gaining knowledge, confers power; if that power is to be used to choose the good and refuse the bad then wisdom must be added to knowledge. This quest for judicious decisions will involve the participation of at least three parties:

• the experts;
  
• the community of possible beneficiaries; and
  
• the general public.

Participation of the experts is essential, as only they can assess the potential risks and benefits of new developments. They have an ethical obligation to do this in as fair and as balanced a way as possible. Final decisions cannot be left to them alone, however, because their monopoly of expertise does not confer a monopoly of wisdom. They cannot be judges in their own cause, because the excitement of the research may cloud their judgement. The interest of the community of possible beneficiaries, whether it be sufferers from a particular disease or farmers on a marginal kind of land, is obvious - but, again, they cannot be judges in their own cause.

The general public has an indispensable ethical stake in what is decided. If this general influence is to be exercised well, it will call for the development of informed and ethically sensitive public opinion. However, there are obstacles in the path to this happening. Much contemporary ethical debate takes the form of the confrontation of opposing single-issue pressure groups. One side claims that X is the best thing ever and we cannot have too much of it; the other, that X is the worst thing ever and we must avoid it at all costs. Whatever X may be, it is unlikely that either of these extreme positions is justified. It is important that society should seek to create forums in which ethical issues can be discussed in a truth-seeking and nonconfrontational manner. The issues that face us are too complex to be dealt with in slogan form.

If this prospect of a rational debate about biotechnology is to be realized, a considerable educational programme will be required. It is clear that many people still lack the rudimentary degree of scientific understanding that is indispensable as the basis for reaching informed, ethical conclusions on these issues. A saddening but instructive example is provided by the case of irradiated food. Because 'radiation' is, in many minds, a sinister word, conjuring up the image of an invisible hazard, this effective way of improving food safety was rejected by the public, who simply refused to buy food so labelled. We must hope that the debates of the 21st century will be both scientifically better informed, and also ethically more subtle, than those of the past decade of the 20th century have often proved to be.