Ethics Overview
[Source: Council of Europe 2000: Working Party on Xenotransplantation, Strasbourg, July 2000. Reprinted with permission.]
Xenotransplantation raises ethical questions about humanity and human activity, the status, welfare, and uses of animals. These will be separated into sections.
Interfering with nature
Today’s scientific innovation is often tomorrow’s commonly accepted treatment. The line between what is natural and unnatural is often very difficult to draw. Medicine seems to intervene in order to prevent ‘natural’ breakdown of diseases, while at the same time medicine is trying to restore ‘natural’ functions and well-being. It is extremely hard to be absolute about what is natural in our modern technological world.
The public has high expectations about what medical technology can and should do. While people are all too delighted to accept the benefits of new medical advances, there is a genuine concern about an interference with nature, which is often characterised as ‘playing God’. In reality, the debate is much more a matter of what limits should be set to the use of technology. In relation to xenotransplantation, the kind of limits under discussion range from such a degree of genetic manipulation of animals to prevent organ and tissue rejection that species lines may be crossed. Pigs must remain pigs and human beings human beings. Genetic diversity must be maintained. Animals need to be properly and appropriately protected. The section on the use and animal welfare explores this further.
Issues of consent
Given the experimental nature of xenotransplantation, at least initially, all the unknown consequences of such innovative treatment of human beings, issues of consent are crucial. As in all medical experimental research, patients must be competent to make proper decisions, have all necessary information about risks, benefits and likely outcomes and be genuinely free to participate and withdraw. In xenotransplantation, there are particular problems. The first recipients are likely to be those in fairly extreme situations, whose medical condition, lack of alternative treatments, and level of desperation may make consent a difficult issue.
Given the potential risks in xenotransplantation, specifically the long term monitoring and surveillance and curtailment of activities, perhaps including procreation, patients are likely to be asked to consent to an extreme level of restriction, monitoring, and post mortem examination. It is hard to see how the normal pattern of a freedom to withdraw can be allowed in the case of xenotransplantation. The key term here is ‘allowed’ for there is little likelihood of legal enforcement of such conditions being possible or acceptable. Those engaged in transplant work stress that the recipients will be well known and therefore it will be easy to assess how willing they will be to conform. Transplant patients are historically conformist. There are already in place in most countries legislative steps to be taken in the event of the need to protect public health in the even of serious transmissible diseases developing. Otherwise, it will be extremely important to assure that patients have been fully informed and have understood the long term implications of being a xenotransplant recipient.
It is ethically permissible for patients to choose to set aside such human rights as those of founding a family or freedom to donate blood, if there is some overwhelming public good to be attained or public harm avoided.
The effects on others
The risks of xenotransplantation are considered potentially so significant that informed consent should be obtained from relatives and family. It is hard to see how such people are able freely to give consent, but it is important that those in close personal relationships with the recipient are as fully informed and educated as possible. Ideally, the informed consent of close relatives and family should be obtained even if this might set aside other moral principles like autonomy, privacy and confidentiality. Autonomy, privacy and confidentiality are never absolute obstacles and communities are entitled to limit them where there is serious harm to the individual concerned or to other people. A high level of risk to public health would be considered an adequate ground for limiting these principles. The morality of including or excluding possible recipients on the grounds of willingness or unwillingness of close relatives to accept responsibility in relation to the recipient is a matter of debate. While the danger is a move away from treating the individual on his or her own terms as an end in him or her self - it is important to recognise that families do have obligations, the medical and nursing staff are well placed to judge the likelihood of a supportive or unsupportive environment and that is in everyone’s interest that the recipient be given the necessary support by close relatives.
Risk
It is vital that the risks and benefits of xenotransplantation are properly assessed and communicated. To protect patients and medical/nursing participants, the use of external risk and expert assessment would provide assurance that there is no untoward pressure or expectations. There is some disagreement what the level of safety and the degree of risk necessary should be before xenotransplantation takes place.
Some people argue that the precautionary principle should be the starting point suggesting that the consequences are likely to be harmful or unknown, we ought not to proceed. If taken literally and to the extreme, then little or no scientific advance would take place. Rather, all those involved in deciding about xenotransplantation must be satisfied that the risk to the individual recipient, their families, the medical and nursing teams, and the general public are minimal and controllable. In the end, there will be no absolute guarantees but the scientific evidence must be clearly objectively clear that there are no real risks to those involved.
Part of such risk assessment recognises that some degree of risk will be acceptable, especially to desperate patients and their families. Likewise medical research staff may regard a degree of risk acceptable in order to establish the validity of a treatment. However, the overwhelming need to gain and maintain public confidence must mean that no xenotransplantation ought to be approved until and unless there is a high level of assurance about safety as possible.
Animals
Human beings already use animals for many purposes including food, clothing, companionship, and labour. The growth of the genetic manipulation of animals and their use for xenotransplantation raises questions about the status, welfare and the limits of use and abuse of animals and in particular the question of the use of non-human primates. Issues that need to be resolved include whether animals have certain fundamental rights and interests and what correlative responsibilities that places on medical researchers and regulatory bodies. Deeply held ideological and religious views undoubtedly affect our attitudes towards animals and how we relate to them and use or limit our use of them.
Commercial interests
There are ethical questions raised about the role of commercial companies in all research, both in terms of setting the agenda and controlling the outcomes. Medical research would not proceed without the financial support of commercial companies and it is only fair that they are able to have an appropriate return for their investment. At the same time, all research and commercial activities must be subject to regulation especially in areas like xenotransplantation when humans, animals and both individuals and the public are at risk and require protection.
The Public
Transparency requires that science is responsible to society as a whole. Informed public opinion needs to be given the necessary and appropriate information in order to co-ordinate a genuine debate about our current attitudes towards xenotransplantation, animal issues and human concerns. Openness in the activities of the regulatory bodies, advisory groups and working parties especially in relation to the scientific issues of risks, benefits, safety and monitoring of humans and animals is a vital part of providing a framework within which proper informed debate may take place.