4. The Bioethics Council’s thinking

In considering the very wide range of views we heard, we are mindful of the need for practical decisions in the area of xenotransplantation. Our thinking needs to result in recommendations about the nature and scope of new legal provisions, and changes in or to the regulatory structure. Our deliberations have also been shaped by the knowledge that we are not operating in a vacuum. Xenotransplantation is well advanced in many countries: it is with us already, whether we like it or not.

This wider context shaped the public dialogue, and also our own thinking about the cultural, ethical and spiritual dimensions of xenotransplantation – which we believe are inseparable from matters of safety. These deliberations are the focus of this section.

4.1 Cultural, ethical and spiritual factors

New Zealanders’ cultural, ethical and spiritual beliefs are far from homogenous, even within groups that might be imagined to share common interests. They are complex, diverse, developing, sometimes reluctantly articulated and often in conflict – within society and within individuals.

However, we believe the following cultural, ethical and spiritual factors are particularly important to New Zealanders, and to the question of whether xenotransplantation should be allowed to proceed.

The need to respond compassionately to the suffering of people and animals

We heard passionate and compelling arguments from people for whom xenotransplantation was not just an abstract issue, but literally a life and death matter. For certain debilitating and life-threatening conditions, xenotransplantation offers hope of cure or relief from suffering. From the people suffering from such conditions, or whose loved ones are affected, the overwhelming message was: we want the option of this technology and we want it now. This view was also heard from people with no personal stake in seeing xenotransplantation proceed.

We recognise that without access to xenotransplantation some people might die; with it, some might live. Some alternative approaches – such as stem cell therapy – might also offer answers, but this is not yet known. Preventative health measures will not successfully tackle some of the health problems that xenotransplantation could potentially treat – some conditions (such as Type 1 diabetes and Huntington’s disease) are not preventable, and prevention messages will be too late for many sufferers of other conditions. Given this uncertainty surrounding the alternatives to xenotransplantation, it remains a legitimate option worth exploring.

The implications of responding compassionately to the suffering of animals are more complex. For some, it implies that xenotransplantation should never be allowed, because it requires animals to experience a degree of suffering. However, refusing to use animals would have far-reaching consequences for the more general use of animals in medical research and for food production. These issues are well beyond the scope of our present work. But we do believe that compassion for the suffering of animals requires us to seek stringent controls over the welfare of animals that might be used in xenotransplantation research or therapies.

Regard for the sanctity of human life

The sanctity of life is one of the core principles underpinning New Zealand society, and indeed humanity as a whole. Regard for life, like a compassionate response to suffering, speaks in favour of helping those with serious medical conditions, and so – to the extent that xenotransplantation might help such people – it speaks in favour of permitting xenotransplantation. On the other hand, the sanctity of life and compassion also speak against imposing the risk of disease on people, and so – to the extent that xenotransplantation does this – they speak against xenotransplantation.

Clearly, the value that society attaches to human life requires that we consider very closely the safety issues presented by xenotransplantation. Some forms of xenotransplantation – such as the transplant of whole organs from primates – undoubtedly present risks that are potentially very serious, both to the individuals who undergo them and to the wider community. Other forms are less risky, if not wholly without risk. We discuss safety issues further below.

Freedom of choice

As in many areas, our individual freedom to make choices about xenotransplantation rubs against the freedoms of others. We may elect to have a xenograft ourselves, but what of the potential risks of spreading disease to countless others who have no such choice? We may find the idea of xenotransplantation offensive, but what of the diabetic who would choose it in an instant to avoid a lifetime of insulin injections? Is it right for one person’s choice to deny another the chance of a better life?

One view is that freedom of choice does not extend to the creation of public risk. That view could be used to justify a complete ban on xenotransplantation. However, as a society, we are prepared to tolerate many activities that pose risks for third parties – such as importing goods from overseas, despite the biosecurity implications – providing those risks are managed and minimised.

The question of personal identity – what it means to be human – is also linked to freedom of choice. In choosing to receive xenotransplantation, would people become somehow ‘less than human’? We heard through the dialogue that people felt very differently about this question – from fearing their fundamental humanity would be compromised, to believing that their identity would be positively enhanced by xenotransplantation.

In our view, how people feel about themselves as a result of xenotransplantation is an intensely personal and psychological issue. However, we believe the question of how other people might perceive, discriminate against or stigmatise those who have undergone xenotransplantation is important. Consideration needs to be given to addressing this issue in human rights legislation.

Kaitiakitanga and stewardship for the earth and its life forms

Our 2004 dialogue with the public on the use of human genes in other organisms revealed strong beliefs about the interconnectedness of human life, other species, and the physical environment. Linked to this was an understanding that humans have certain responsibilities towards other forms of life: to protect the integrity of other species, to avoid using them in ways which caused suffering or the destruction of life, to safeguard other species out of concern for both their future survival and ours. For some people, these beliefs were part of an explicitly religious or spiritual world view; they were also closely linked with the Māori concept of kaitiakitanga, or guardianship.

These same ideas are important in our thinking about xenotransplantation. The different forms of this technology depend heavily on animals for research and as potential sources of cells, tissues or organs. We believe human beings have a duty of care towards these animals.

Safety

The question of whether xenotransplantation is safe remains unanswered. Different procedures involve different levels of risk, and there is a still a great deal to be known about all of them.

So far, the risks that have been associated with xenotransplantation include not only the failure of therapies or transplants, but also the possibility of cross-species infection. Thus, risks to individual safety may also be risks to public safety, with the worst-case scenario being a previously unknown animal infection spreading rapidly throughout the community and reaching epidemic proportions. Although no such cross-species infections have been reported overseas to date, the potential consequences are so serious it would be irresponsible to ignore the risk. We therefore share the sense of caution we heard from many people (including enthusiastic proponents of xenotransplantation) for whom support for xenotransplantation was conditional on assurances of its safety.

Some New Zealanders have already undergone xenotransplantation in other countries. This has been seen as justification for allowing it to proceed here: perhaps it is better for New Zealanders to undergo xenotransplantation in a well-regulated environment here than in other countries where the risk to life may be greater?

However, we found this ‘inevitability’ argument to be speculative. The size of the risk depends on the type of xenotransplantation that would be done in New Zealand, and on how many New Zealanders would use it if it were available here compared with the number who would use xenotransplantation overseas. These are unknowns. So, if xenotransplantation were to be allowed here, we cannot be certain that the risk would be lower for the New Zealand public if people had treatment here rather than overseas.

The ethical question about safety and xenotransplantation cannot be avoided. As we heard, the way people think about xenotransplantation and safety is deeply entwined with their ethical beliefs. Thinking about safety also means considering whether the compelling need to save a life outweighs possible risks to individual or community safety. It means asking whether it is right to restrict the freedoms and privacy of xenograft recipients in the interests of public health. It means considering whether it is right to make individual choices that impose risks on third parties who have not made those choices.

As a country we permit many activities that pose safety risks. We encourage tourism, despite the ease with which jet travel allows the spread of communicable diseases. We allow imports of products from overseas, despite known biosecurity risks. In these cases and others, society is prepared to allow activities that impose a degree of risk providing the risks are minimised and managed in accordance with sound regulations and policy.

Moreover, because xenotransplantation involves a number of diverse and rapidly developing technologies, new information about its safety and efficacy is continually emerging. In our view, this fluid situation means that safety grounds are currently insufficient to justify an outright prohibition on xenotransplantation.

What seems more suitable is a case-by-case approach to xenotransplantation – providing it was subject to stringent and enforceable regulations, and administered by a competent organisational and regulatory framework capable of assessing and managing the particular risks associated with each individual case. This case-by-case approach could mean that some of the riskier forms – even, perhaps, all xenotransplantation – might not be allowed to proceed.

Summary

In thinking through these cultural, ethical and spiritual factors, we found nothing that justified a complete prohibition on xenotransplantation, given the compelling human need arguments. But nor were we led to think that xenotransplantation should be allowed to develop completely unfettered.

Xenotransplantation could offer some New Zealanders the chance to suffer less, and perhaps even allow some to live who would otherwise face the prospect of premature death. We do not believe they should be denied that opportunity.

However, xenotransplantation raises health risks that are yet to be adequately quantified and understood. Its development must take place within a regulatory and decision-making framework that is capable of adequately managing those risks, and whose decisions about xenotransplantation applications take into account cultural, ethical and spiritual factors – as well as the risks. Those decisions must also reflect the Treaty relationship between Crown and Māori – at the very least, by ensuring a Māori presence on xenotransplantation decision-making and monitoring bodies.

We believe that xenotransplantation decisions must be made on a case-by-case basis. Xenotransplantation takes many different forms, each involving different safety issues and levels of risks. New information about technologies and possible risks is emerging constantly. In this context, case –by-case decision-making is the right response. We note that in some instances, this may mean some applications or some specific forms of xenotransplantation are not allowed to proceed.

We also note that it can be very difficult to find consensus about cultural, ethical and spiritual factors at an abstract level. Yet our experience has been that when those factors are brought to bear on specific cases or decisions, agreement is much more likely. Again, case-by-case decision-making is the appropriate course of action.

Therefore, the Bioethics Council recommends that:

In considering how this recommendation could be put into effect, we note the existing regulatory and decision-making framework of animal and human ethics committees for dealing with ethical issues associated with biotechnology. This framework may or may not be adequate to deal with xenotransplantation – a biotechnology which does, we believe, raise distinctive issues. For example, xenotransplantation research raises the question of whether participants in xenotransplantation trials should be required to waive the usual right to confidentiality, and the freedom to withdraw from trials at will.

It may be appropriate to establish a specialised xenotransplantation committee (as the United Kingdom has done), charged with considering cultural, ethical, spiritual and safety issues. Alternatively, the functions, expertise and resources of the existing bodies could be developed and expanded so that they are equipped to manage the specific challenges of xenotransplantation. In either case, as this is a developing technology, it is important for an appropriate monitoring regime to oversee both the adequacy of the regulatory/decision-making framework and developments in the technology itself.

We note that there is currently no legal mechanism that requires researchers to submit their research to a human ethics committee. It is important that this gap be filled in the case of xenotransplantation research.

Therefore, the Bioethics Council recommends that:

4.2 Māori and xenotransplantation

Many Māori believe xenotransplantation has much to offer, in terms of addressing the health needs of Māori and the shortage of Māori organ donors. For some, this ‘human need’ argument is sufficient, and negates any cultural, ethical and spiritual concerns. Others – while recognising the human need – are troubled by the fact that xenotransplantation does not appear to be validated by Tikanga Māori and the wider Māori world view. They are actively seeking guidance about whether the two can be reconciled and, if so, how. Still others say that the Māori world view and tikanga do not – and never will – accommodate xenotransplantation.

We believe a possible way forward is for Māori to be encouraged to examine or develop the fundamental tikanga and mataraunga they need to make decisions about xenotransplantation. It is only by having an adequate frame of reference and knowledge base that Māori can determine if and how they participate in xenotransplantation, individually and collectively.

At the moment, that frame of reference does not appear adequate. Developing it would require the involvement of participants we did not hear from extensively in our dialogue process – tohunga who might advance Māori knowledge, including by providing new karakia; kaumatua to discuss new ideas with hapū and iwi; people with knowledge of wider Polynesian spiritual concepts and understandings that might enrich fundamental Māori concepts. They would join the many other Māori who have already become involved in the xenotransplantation dialogue as scientists, policy-makers and potential users.

To be effective, this dialogue or wananga needs to be an intra-cultural process, called by a person of status within the Māori world. While Government and government agencies (including the Bioethics Council) might have a part to play in terms of providing information and support, it would be primarily an enabling role rather than a prescriptive or leading one. The outcomes of this wananga would need to be carefully considered in the context of Tikanga Māori: who do those outcomes ‘belong’ to, how would they be promulgated and by whom?

The Bioethics Council believes this intra-cultural dialogue is essential to enable Māori to be part of decision-making on xenotransplantation, and is willing to provide further advice to the Minister for the Environment about how this could be achieved.

Therefore, the Bioethics Council recommends that:

4.3 The interests of animals

The Bioethics Council considers there are significant ethical issues relating to the welfare of animals used in xenotransplantation – either in research and trials, or as sources of cells and organs.

Some in the community question whether it is right for animals ever to be used to benefit humans. This is an important question but, as we have already said in relation to the need for a compassionate response to the suffering of animals, it is too far-reaching to consider in our present deliberations about xenotransplantation.

However, we do believe it is important that when animals are used to benefit humans, they do not experience undue suffering. This view came through very strongly in many submissions, which supported xenotransplantation only if it involved no needless cruelty to animals.

This sense that humans have a ‘duty of care’ towards animals guides our thinking on two aspects of xenotransplantation: the work of institutional animal ethics committees, and the adequacy of present legislation governing the use of animals.

Animal ethics committee

Throughout the dialogue process, we heard questions about the adequacy of our animal ethics committees to safeguard the welfare of animals used in research. Particular concerns included the independence of such committees; their composition, decision-making processes and standards; how transparently they operate; and the availability of information. While this disquiet extends beyond xenotransplantation research alone, we think it is important to acknowledge concerns about the work of institutional animal ethics committees.

While we appreciate committee members’ desire for some degree of confidentiality, and accept the need for anonymity out of concern for the personal safety of members, we feel that this is contributing to something of a ‘standoff’ between the committees and the public. This may be impeding the development of a more productive relationship that could work to the benefit of all, including animals.

While we make no specific recommendation, the Bioethics Council will be drawing this issue (which is wider than xenotransplantation alone) to the attention of the minister responsible for animal ethics committees.

Animal welfare legislation

The present Animal Welfare Act 1999 offers special protection to non-human hominids, saying they can be used in research, testing or teaching only when it is in the best interests of the particular animal or their species. However, the ‘non-human hominid’ category does not include monkeys (both old world and new world) and prosimians (lemurs, lorises etc). It would probably come as a surprise to many New Zealanders to find that monkeys, for example, are not specifically protected by our animal welfare legislation.

We believe that the Act’s special protection should be extended to protect all primates from being used in xenotransplantation research or therapy. Primates are highly intelligent, and very close to humans in their social organisation and behaviours. As such, they have a special moral status that means they should not be used in xenotransplantation research or as source animals.

Therefore, the Bioethics Council recommends that:

4.4 Xenograft recipients and public health

The main safety concern at present is posed by xenotourism – New Zealanders returning home after travelling overseas for xenografts, and visitors to New Zealand who have had xenografts. What should be done about xenotourism is a question that arises whether or not xenotransplantation is permitted in New Zealand.

We believe there is a strong public health argument for having some kind of notifiability or registration regime to cover xenograft recipients. However, we do not support the somewhat draconian measures – public identification of recipients, quarantine, compulsory monitoring – which some people have advocated. We do not believe that the risk to the community warrants a response that places such a burden on the individual, and that potentially exposes them to stigmatisation and discrimination. Moreover, such regimes are likely to be actually counter-productive to public health by discouraging xenograft recipients from seeking medical care or advice in order to avoid detection.

A national register of all people in New Zealand, residents and visitors alike, who have undergone xenotransplantation would be one solution. Traceability would be the main aim. In the event of any outbreak of diseases that might be linked to xenotransplantation, those on the register could be readily contacted and offered access to medical treatment and information – both for their own sake and the sake of the wider community.

New Zealanders having xenografts in New Zealand at some future time would need to be placed on the register by the medical practitioner concerned. Medical practitioners conducting xenotransplantation research on human subjects would also be required to place those individuals on the register. In placing the onus on medical practitioners to advise the public health authorities, we are proposing a similar approach to the present system whereby doctors must advise the Ministry of Health whenever, in their professional capacity, they encounter someone with a specified communicable disease.

Meanwhile, people entering the country from overseas (including returning New Zealanders) would be required to declare that they have had a xenotransplant and to supply the public health authorities with their address and contact details.

Such a system is more likely to encourage compliance than draconian measures, which there is good evidence for thinking would be counter-productive for public health. Although the regime conflicts with what we normally regard as important individual rights – to confidentiality and privacy – we believe this is legitimate in the interests of public safety. Privacy concerns could and should be mitigated by regulations covering access to and use of the information contained in the register.

The issue of possible stigmatisation and discrimination against xenograft recipients seems to us an important one. The Human Rights Commission is probably the organisation best suited to considering whether and how this issue should be addressed under human rights legislation.

A related area we also believe requires investigation is liability in the event of xenotransplantation causing a public health risk. Who would be accountable? How would costs be determined and allocated? It would be appropriate for the Law Commission to investigate this issue, in the same way that they earlier investigated liability issues in respect of genetic modification.

Therefore, the Bioethics Council recommends that: