8. Ethical aspects

8.1 Introduction

The production of genetically modified animals raises a variety of legitimate ethical concerns. The need to address these concerns openly and without prejudice is further amplified by sections of a critical public that question some of the achievements of modern biotechnology. Responsible decision-making and policy needs to integrate ethics among the salient factors in the preparatory stages of risk analysis.

Ethics is rooted both in the world religions and in secular philosophies, while a sense of morality and moral value is common for everybody. Ethics comprises both a positive dimension relating to our conceptions of the good life/society, and a negative dimension relating to our judgements of what is morally wrong. For instance, owing to religion-based food practices relating to eating pork, the utilization of genetic material from pigs could present problems.

8.2 Environmental ethics and animal welfare

In large parts of mainstream Western ethics, the objects of our moral concerns have been human beings. With the advance of our knowledge, many people have come to realize that there is ample reason to extend the realm of moral concern to animals and perhaps even to ecosystems. This has led to discussions on the moral status of animals, as well as to increased attention being given to animal welfare issues, also related to transgenic animals. For instance, one set of early experiments with growth enhanced salmon showed some individuals with cranial deformities (Devlin et al., 1995). As a general, but not unexceptional, rule the intended use of GM animals for food production bespeaks the interest of the producer to ensure or improve the health of animals and good animal welfare. Therefore, aspects of animal welfare of transgenic animals need to be evaluated on a case-by-case basis by competent bodies.

8.3 Uncertainty

Ethically responsible decision-making demands, inter alia, both the utilization of the best available knowledge and an awareness of the relevant uncertainties involved. While it is widely acknowledged that good risk assessment demands a measure of uncertainty, the common instruments to make these uncertainties visible are still limited. However, research on this topic has made significant progress during the last decade, and valuable and useful instruments to represent the relevant uncertainties are now available (Walker et al., 2003). This is ethically significant because, in some cases, the uncertainties relate to our state of knowledge (thus often indicating the need of more research) but, in other cases, the uncertainties relate to inherent characteristics of the system under study, e.g. chaos or complexity, or multiple states of equilibrium without linear and deterministic state change. In the latter cases of inherently limited predictability, we have to adopt a responsible scheme for the management of these uncertainties. This point is important both for the use of precaution in risk management and for the provision and presentation of scientific findings as the basis for such management. Precaution does not assume an unrealistic notion of zero-risk. Sometimes the best precautionary action is carefully controlled, monitored and stepwise development. There is a need to address explicitly the uncertainties involved in our assessments, and to adopt schemes for their responsible management.

8.4 Transparency and public deliberation

The recognition of consumer autonomy and the right of free and informed market choices is an aspect of responsible management. Another aspect relates to the worry in sections of the public that the new genetic technologies may not be used for the “right” or ethically justified ends. The distribution of risks and benefits may be morally problematic, and the scope of benefits may be wanting. At present, even the lack of data on such distributions is a concern. Similar concerns relate to the technological divide and the unbalanced distribution of benefits and risks between developed and developing countries. Often the problem becomes even more acute through the existence of intellectual property rights and patenting that places an advantage on the strongholds of scientific and technological expertise. Equity and fairness issues are thus obviously important. All these considerations point towards the positive dimension of ethics, i.e. a discussion of purpose, benefits and risks. There is a societal need to address these issues upfront, and in the early stages of development (Sagar, Daemmrich and Ashiya, 2000; Kapuscinski et al., 2003). Proactive assessment is indicated, and the need for scientific data to inform such assessments should be described. Risk managers and decision-makers should shoulder this task in collaboration with stakeholders.

8.5 The role of ethical principles in assessments

In relation to human health and medicine there is already a tradition of carrying out practical ethical assessments. Four principles have been established as fundamental in the biomedical field: respect for autonomy, beneficence, non-maleficence and justice (Beauchamp and Childress, 2001). These principles seem to be widely accepted, represent important ethical theories and cover most of the problems appearing in the biomedical field. Within the field of genetically modified animals a similar framework needs to be introduced if ethics is indeed to become an integral part of regulation and guided policy advice. Extensions of the principle approach in biomedicine to other technological and environmental issues have been carried out e.g. in the ethical matrix approach (Mepham, 1996; Kaiser and Forsberg, 2000; Schroeder and Palmer, 2003). The basic idea in this framework is to combine the use of a variety of principles with the interest-related perspectives of the various stakeholders and other potentially affected organisms and their environment. A schematic version of one such approach is presented in the next paragraph. The rationale of these frameworks and approaches is to make ethical assessment more transparent and more methodical, and thus amenable to quality assurance.

8.6 A schematic ethical assessment

Assuming that we want to assess the ethical aspects of a certain genetic modification of a fish species for food production in a region, following the ethical matrix approach we would first address the issue of who the relevant stakeholders are. We also need to agree on potentially affected organisms and their components of the environment, for example fish and other biota. A proper set of ethical principles then needs to be established, for instance, justice/fairness, dignity/autonomy and welfare considerations as comprising both the elimination of negative welfare and the increase of positive welfare. Once a common understanding of these principles is ensured, it is important to specify the principles for each interest perspective. Through the presentation of an example ethical matrix (see Table 2) it becomes clear that some of the cells in this table (indicated in grey) relate directly to the scientific description in the safety and benefit assessments of GM animals. Thus there is an overlap between the ethical assessment and the risk assessment and management. A description of specific consequences of the new technology as well as uncertainties in our knowledge is now possible within the matrix. This enables a broader evaluation of the issues.

TABLE 2. Simplified ethical matrix (for illustrative purposes only - grey cells in the matrix also relate directly to the scientific description of safety and benefit assessment of GM animals)