New Zealand is clearly not ready to manage the risks associated with the use of animal cells in humans.
An application for such a trial is currently before the Minister of Health. However, official and other documents researched by the Sustainability Council strongly argue that significant public consultation is required before any application can be considered. This is needed to help develop regulatory requirements and public health protection measures that remain outstanding.
The application by Melbourne-based company, Living Cell Technologies (LCT), is the first to test the regulations governing this procedure – known as xenotransplantation – since new legislation in 2002. Important legal and public policy issues that have yet to be worked through include:
• How to ensure patients can legally be monitored on a life-long basis for infectious diseases;
• How and when independent facilities will be established for: a national register, biological sample archive, and monitoring;
• Who bears liability for the costs associated with any novel disease outbreak; and
• Ensuring consent to the risks involved is also obtained from the public.
Transplantation of animal cells and organs into humans is widely understood to carry the risk of introducing novel infectious diseases into the human population. Decisions around the use of xenotransplantation therefore involve balancing the health of the wider community against the merits of experimental procedures for treating individual members of the community.
The question of informed consent illustrates the complexity and significance of the issues to be addressed. Life-long monitoring of xenograft recipients and their close contacts is considered necessary to protecting community health. Yet under current law, requiring this would breach the rights of individuals to withdraw their consent at any time (provided for in the Bill of Rights and the Health and Disabilities Code).
As the Health and Disabilities Commissioner stated in 2005, the risk of cross-species infection also means “individual consent to xenotransplantation research and treatment is insufficient”. Instead, he clarified, ‘collective consent’ is required for this technology, necessitating “more public discussion […] to ensure that the public are informed and willing to take that risk before xenotransplantation proceeds.”
The requirement for collective consent in particular means full and timely consultation will need to be undertaken with the public before the regulatory regime is finalised. This has yet to be planned for.
The New Zealand Government has been cautious in the past – declining previous applications to conduct clinical trials.
There is no need to rush decisions about the regulatory framework as there are no timeframes under which the Minister is required to respond to the current application. The baseline requirements that must be agreed upon first have been well flagged in government documents for a number of years so there are no grounds for short-cutting due public process.
Reference: Health and Disabilities Commissioner (2005) Submission on the Bioethics Council discussion document, The Cultural, Spiritual and Ethical Aspects of Xenotransplantation: Animal-to-human Transplantation.
Read the Sustainability Council Report: When Venturing Into Foreign Parts
1. Living Cell Technologies is seeking approval to conduct Phase I/IIa clinical trials using its experimental product “Diabecell”. The procedure is proposed as a treatment for patients with Type 1 Diabetes, and involves introducing pig pancreatic islet cells coated in alginate, with the target being insulin production. Thus far, the product has been approved for clinical trials in Moscow, which began in April this year.
2. Medsafe and a regional ethics committee have recommended that the application be approved. Government has determined not to release the Medsafe or ethics committee assessments in advance of taking a decision. It is therefore not known what controls are proposed for the trials; or what policy issues the committees saw as requiring resolution before an approval can be considered.
3. Xenotransplantation is regulated under Part 7A of the Medicines Act 1981, and requires that all applications be considered by the Minister of Health, who must be satisfied that the procedure does not pose an unacceptable risk to the public; that the risks can be managed; and that the cultural, spiritual and ethical issues are addressed. Should there be uncertainty or gaps in information that would allow those conditions to be clearly fulfilled, then the Minister may appoint or consult an existing entity to address them and to open their investigations to the public. (S96F)
4. In 2005, the Bioethics Council held a public consultation on the cultural, ethical and spiritual dimensions of xenotransplantation. It did not, however, consult on or explore safety and efficacy issues, which are central to the outstanding public policy issues involving xenotransplantation.