King Annette: Medicines (Specified Biotechnical Procedures)  Amendment Bill — First Reading 
King Annette: Medicines (Specified Biotechnical Procedures)  Amendment Bill — First Reading 
[Volume:625;Page:19758] 
Hon ANNETTE KING (Minister of Health) 
: 
 I move  
That the Medicines (Specified Biotechnical Procedures) Amendment Bill be now read a first time. 
 At the appropriate time I will move that the bill be referred to the Health Committee for consideration that the committee present its final report on or before 28 May 2005 and that the committee have the authority to meet at any time while the House is sitting except during oral questions and during any evening on a day on which there has been a sitting of the House and on a Friday in a week in which there has been a sitting of the House despite Standing Orders 191 and 194(1)(b) and (c). 
 Xenotransplantation is the implantation of living biological material from animals into humans. The Medicines (Specified Biotechnical Procedures) Amendment Bill extends the period of the current controls on xenotransplantation until 31 December 2006 with the ability for this state to be extended by Order in Council if necessary. The current controls were introduced in response to concerns about the potential of threats of xenotransplants transmitting new infections to recipients and to the wider community; the adequacy of regulatory review processes; and the cultural social and ethical issues associated with xenotransplantation. The current controls allow xenotransplantation trials to be considered and approved by the Minister of Health but require strict criteria to be met before an approval is given. 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. After this state the scientific and ethical oversight will return to the controls utilised for clinical trials of medicines contained in section 30 of the Medicines Act. Section 30 controls were previously identified as being inadequate and despite further information on xenotransplantation being published I am advised there is still a need for additional oversight of this controversial emerging technology. 
Existing controls cannot be extended further under existing legislation hence the need for this bill. Ongoing controls are needed on xenotransplantation because it is still only an experimental technique. It is unclear whether this technique would be successful within humans. There is also a risk of transmitting viruses from animals to humans. 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 would function properly in a human. 
Evidence indicates that xenotransplantation may be associated with an increased risk of transmission of a wide range of viral bacterial and other infections known to occur in the sourced animals. There is a theoretical risk that xenotransplantation could increase the risk of new infections jumping the species barrier from animals to humans. In view of concerns about the safety and efficacy of xenotransplantation similar jurisdictions—including Australia Canada and the UK—have stringent controls on xenotransplantation. To my knowledge there are currently no clinical trials under way in those countries. In December 2004 the Australian National Health and Medical Research Council announced a 5-year moratorium on clinical trials of xenotransplantation. New Zealand would be going out on a limb if we allowed these controls to lapse. I commend this bill to the House.