Launch of the Xenotransplantation report 13 December 2005 - Questions and Answers

The Report on Xenotransplantation, ‘The Cultural, Ethical and Spiritual Aspects of Animal to Human Transplantation’ by Toi te Taiao: the Bioethics Council – has been presented to the Government after an extensive dialogue process and has been informed by the views of a wide range of New Zealanders.

Q. What is the role of the Bioethics Council?

• Toi te Taiao: the Bioethics Council was established by the Government in 2002 to consider the cultural, ethical and spiritual issues raised by biotechnologies such as xenotransplantation and ensure that the use of biotechnology has regard for the values held by New Zealanders.
• Within its role the Bioethics Council is expected to:
  • Provide independent advice to the Government on biotechnological issues involving significant cultural, ethical and spiritual dimensions.
  • Promote and participate in public dialogue on the cultural, ethical and spiritual aspects of biotechnology, and enable public participation in the Council’s activities.
  • Provide information on the cultural, ethical and spiritual aspects of biotechnology.

Q. Why did the Council prepare this report?

• The Bioethics Council decided to prepare this report in light of the proposed legislation.

Q. What was the role of the Bioethics Council in preparing this report?

• The role of the Council was to talk with and listen to New Zealanders through the dialogue programme to hear their views on the cultural, ethical and spiritual aspects of xenotransplantation before making recommendations to government.
• It is not the Council’s role to say whether xenotransplantation is safe or effective from a scientific perspective. That will be determined by the Ministry of Health.
• This report presents recommendations based on what was heard during the dialogue process as well as the Council’s own conclusions.

Q. What is the Council’s position on xenotransplantation?

• Council members have open minds on this matter. The Council drew the conclusion in this report, from the views expressed through the dialogue process, that there was nothing to justify a complete prohibition on xenotransplantation, given the compelling human needs argument, but that it should be able to develop with decisions made on a case by case basis.
• While the Council has drawn its own conclusions and made recommendations as an outcome of the dialogue process in this report, final decisions rest with Government.

Q. What did the dialogue process entail?

• In early 2005, the Council released a discussion document, The Cultural, Spiritual and Ethical aspects of Xenotransplantation: Animal to Human Transplantation. During April and May, a series of nationwide dialogue events were held throughout New Zealand. The public were able to get involved in a number of activities during this period: by joining an online discussion forum, by making a submission by mail, phone, online, visiting the website for more information or by attending a dialogue event.

Q. What is a dialogue event?

• Dialogue events provide participants with a non-threatening ‘space’ to discuss and debate the issues and examine their own deeply held convictions without fear of personal attack.

Q. How many dialogue events were held?

• Meetings were held in a two stage approach, over two days. Eight events (sixteen sessions in all) were held.

Q. How many people participated in the dialogue process?

• People’s involvement varied enormously depending on the nature of their contribution. Around 300 people participated in face-to-face events; many more participated through online and submissions.

Q. To what extent did the Council listen to Maori views?

• One of the Council’s key tasks and Treaty responsibilities is to engage with a wide range of Maori, and incorporate their voices and perspectives, acknowledging and exploring the diversity of their opinions.
• The Council heard from a wide range of Maori – young and old, kaumatua, kuia professionals, Christians, atheists and many more during the dialogue process. Two of the dialogue events provided specific opportunity to focus on Maori perspectives in a tikanga environment.
• Maori suffer disproportionately from the conditions which xenotransplantation may help alleviate e.g. diabetes.

Q. What are the key recommendations of the report?

1. Xenotransplantation (animal to human, animal–to-animal) be allowed to develop in New Zealand, with that development being shaped by:
   • the resolution and management of safety issues by a competent authority
   • the Treaty relationship between the Crown and Maori
   • the cultural ethical and spiritual factors that matter to New Zealanders, including a compassionate response to the suffering of people and animals, the sanctity of human life; freedom of choice, kaitiatikanga and stewardship for other life forms; and safety.
2. The Government implements an appropriate regulatory and decision-making framework to guide the development of xenotransplantation. This may involve the establishment of a specialist body, or the further development of the existing framework.
3. Decision-making bodies be guided by national standards and have access to expertise. They must be adequate to deal with the special challenges of xenotransplantation – including its cultural, ethical and spiritual dimensions.
4. All xenotransplantation research involving human subjects be legally obliged to comply with the requirements of the regulatory framework.
5. The Government puts in place a monitoring body to oversee the development of the regulatory and decision making framework, and developments in xenotransplantation technology.
6. a) The Minister for the Environment enables through the provision of funding, an intra-cultural dialogue process (wananga) for Maori to examine through their knowledge base from which to engage with xenotransplantation and other forms of biotechnology. This would address tikanga and spiritual, ethical and cultural issues within te ao Maori, including whakapapa, karakia etc.
   b) Subject to tikanga, the knowledge/matauranaga emerging from this intra- cultural dialogue be widely promulgated.
7. That special protection afforded by the Animal Welfare Act 1999 to non-human hominids be extended to include all members of the order of Primates.
8. A register of New Zealanders and other people entering New Zealand who have undergone xenotransplantation etc.

Q. What will happen with the report now it has been presented to the Minister?

• These matters must ultimately be decided through our democratic institutions. Government will consider our report and, presumably, other information on ethical and safety issues. It may decide to legislate. These matters are a decision for the Government.

Q. What current legislation covers Xenotransplantation?

• Xenotransplantation is not presently undertaken in New Zealand, and under the current legislation (Medicines Act 1981) xenotransplantation trials require specific approval of the Minister of Health.

Xenotransplantation

Q. What is xenotransplantation?

• Xenotransplantation is the transplantation of living cells, tissues or organs from one species to another. The focus of the Bioethics Council is on animal-to-human transplantation.
• Xenotransplantation derives from the Greek word xenos, meaning foreign. The issues surrounding this procedure come from associating something ‘foreign’ with the human body.

Q. Why is xenotransplantation an important issue to consider?

• Human-to-human transplantation has become a successful way of treating various human diseases and conditions, from heart disease to kidney failure. But while the scale of success has led to an accelerating need for tissue, cellular and organ transplants, the number of donors has not risen to the same extent. The ageing New Zealand population is only going to make this worse, leaving many in need. Xenotransplantation could make an important contribution to dealing with this problem.
• The use of animal tissue as an alternative has always been thought to be too difficult because of rejection by the human immune system, but advances in science have brought this option back into consideration.

Q. What can xenotransplantation potentially offer New Zealanders?

• Xenotransplantation may offer new treatment options for serious conditions such kidney and liver failure, Huntington’s and diabetes. It also offers a possible solution to the worldwide shortage of human tissue and organ donors.

Q. What is xenotourism?

• Xenotourists are New Zealanders who return to this country after undergoing xenotransplantation overseas, and visitors from other countries who have had xenotransplantation? The general view was that this is inevitable, and that New Zealand needs an effective regime for managing any possible risks.

Q. What is the case against xenotransplantation?

• It raises significant ethical issues, such as:
  • How should we weigh the welfare of animals against that of humans?
  • How much risk should we expose ourselves to infectious diseases from xenotransplantation?
  • Do we know all the risks?
  • What about the impact on animals?
  • Is Xenotransplantation interfering with the natural order?

Q. What is the case for Xenotransplantation?

• Xenotransplantation is becoming safer as technical medical problems are solved.
• It could make a significant contribution to the treatment of conditions such as heart disease and kidney failure.
• With the number of human tissue, cellular and organ donors falling well short of demand Xenotransplantation presents a strong possible alternative.
• The ageing New Zealand population is going to increase demand.

Q. What are the health risks?

• Apart from the immediate health risks of rejection that are gradually being overcome, the greatest potential risk is to public health through the transfer of viruses from animals to humans. The risk of this is generally considered low.