Ririnui Mita: Medicines (Specified Biotechnical Procedures)  Amendment Bill — Third Reading 
Ririnui Mita: Medicines (Specified Biotechnical Procedures)  Amendment Bill — Third Reading 
[Volume:625;Page:20701] 
Hon MITA RIRINUI (Associate Minister of Health) 
 on behalf of the 
 Minister of Health 
: I move  
That the Medicines (Specified Biotechnical Procedures) Amendment Bill be now read a third time 
. This bill extends the period of the current controls on xenotransplantation until 31 December 2006 with the ability for the date to be extended by Order in Council if necessary. The current controls were introduced in response to concerns about the potential threat of xenotransplantation transmitting new infections to recipients and to the wider community. There were also concerns about the adequacy of regulatory review processes and the social and ethical issues associated with xenotransplantation. 
The current controls allow xenotransplantation trials to be considered and approved by the Minister of Health on a case by case basis. Strict criteria must be met before any approval can be given. New Zealand has therefore adopted a rigorous regulatory approach rather than forcing a moratorium. No applications have been made to the Minister of Health under the current provisions. Without this bill the existing additional controls on xenotransplantation will end on 30 June 2005 with the expiry of Part 7A of the Medicines Act 1981. After this date the scientific and integral oversight will return to the controls utilised for clinical trials of medicines contained in section 30 of the Medicines Act. The section 30 controls were previously identified as being inadequate and despite further information on xenotransplantation being published the Minister of Health is advised that there is still a need for additional oversight of this controversial emerging technology. 
Xenotransplantation is currently an experimental technique only. There are only a small number of animal or human studies of possible efficacy and it is far from clear whether a transplanted animal organ could function properly in a human. In the opinion of a number of authorities the transmission of retroviruses to humans via xenotransplantation is a credible potential risk to public health. However the magnitude of the risk is the subject of considerable debate amongst experts. In the view of concerns about the safety and efficacy of xenotransplantation similar jurisdictions including Australia Canada and the UK have stringent controls on xenotransplantation. To the knowledge of the Minister no clinical trials are currently under way in these countries. 
In New Zealand the Bioethics Council is currently undertaking an extensive public dialogue on xenotransplantation. This involves in an open submissions process an online forum and a series of meetings to ascertain the level of public acceptability around this technology. They expect to complete that process and to advise the Government of the outcome in September 2005. Allowing the controls on xenotransplantation to lapse would pre-empt that process. 
The Minister of Health is monitoring international developments and regulatory approaches to xenotransplantation and emerging research on the safety of xenotransplantation. The ministry is also undertaking work on the type of legislation that may be required for this practice in the future. This work has been undertaken as part of the Ministry of Health’s review of the regulation of human tissue and tissue-based therapies. Finally as many of the risks associated with xenotransplantation carry severe consequences and are uncertain this Government is proposing a precautionary and rigorous regulatory approach as already adopted by Australia Canada and the UK.