KEY POINTS:
Health Minister Pete Hodgson should be required to hold widespread public consultation before approving the transplant of pig parts into humans - because the country is ill-equipped to tackle a new disease that could arise from the treatments, a Wellington lobby group said yesterday.
"Significant public consultation is
required before any application can be considered," Stephanie Howard, of the Sustainability Council of New Zealand, said.
"There has been no public consultation on how - if at all - the public health risks can be managed."
New Zealand is ill-prepared to prevent and control outbreaks of new disease emerging from transplanting animal cells into people, according to the peer review.
Ms Howard, projects director at the council, said the research - derived from a study of the legislative framework around clinical trials - suggests there are important legal and public policy issues which have yet to be worked out.
Chief among those is how the country would manage the outbreak of a new infectious disease created by animal cells in the human body.
"The risk is rare, but the potential to introduce a new disease which could cause a pandemic is there," said Ms Howard.
A Melbourne-based company, Living Cell Technologies, has applied to insert pig cells - known as xenotransplants - into eight type 1 diabetics at Auckland's Middlemore Hospital.
The proposed trial has jumped three hurdles after being approved by medicines watchdog Medsafe, the Gene Technology Advisory Committee and a regional bioethics committee.
The decision now rests with Mr Hodgson.
Ms Howard said HIV-Aids, Sars and the 1918 influenza pandemic were examples of the potential impact of viruses crossing from animals to humans.
"There has been no public consultation on how - if at all - the public health risks can be managed," she said.
Executive director of the council Simon Terry said new technology raised potential benefit for diabetes sufferers, but it had to be weighed against the risk to the wider public.
A spokeswoman for Mr Hodgson said yesterday the minister had not yet read the application from Living Cell Technologies so would not comment further.
There was no timescale for when it was due, she said.
However, Dr Paul Tan, managing director of Living Cell Technologies, said all the issues raised in the report were being worked through.
"We've proposed the way a national register should be set up and we have been in constant communication with authorities on how to set up the rest of the legislative framework."
Dr Tan said the risk of disease caused by xenotransplantation was minor and the trial small.
"Nevertheless, we need to be cautious and that's why we are working through the process."
The company last month told investors it expected Mr Hodgson to accept the regulatory approvals in the next few weeks.
As part of the development of its Diabecell product it has already implanted cells from the pancreas of specially bred New Zealand pigs into the abdomens of six Russian adults who have had type 1 diabetes for at least 10 years.
Concerns over new diseases led former health minister Annette King to stop the original pig cell trials in New Zealand by Living Cell Technologies' medical director, Professor Bob Elliott.
He injected half a dozen diabetics with pig islet cells in 1996 and one, Michael Helyer, of Auckland, was still gaining insulin from them when he was tested last year.
Australia has a moratorium on xenotransplantation until 2009.
During a Bioethics Council probe of ethical issues in xenotransplantation in 2005, Health and Disabilities Commissioner Ron Paterson warned individual consent to xenotransplantation research and treatment was "insufficient" and that "collective consent" was necessary.
Ms Howard said the key was to ensure that consent to the risk involved was obtained from individual patients and also the public.
"LCT is seeking to place NZ at the forefront, not only of conducting clinical trials, but also in managing and responding to the potential emergence of novel infectious disease in trial recipients and the wider community."
Main pitfalls
Sustainability Council says New Zealand is unprepared for:
* Legally monitoring patients on a life-long basis for infectious diseases.
* Maintaining a national register and biological sample archive.
* Liability for costs associated with any new disease outbreak.
* Ensuring public consent to the risks involved.
