I, David Cunliffe, Minister of Health, pursuant to section 96C(1) of the Medicines Act 1981, hereby authorise Living Cell Technologies Pty Ltd (LCT) to conduct a clinical trial involving xenotransplantation as described in its application dated the 28th day of September 2007, subject to the conditions already imposed by the Northern X Regional Health and Disability Ethics Committee, and the following additional conditions:
1. Patient information and tissue samples relating to the clinical trial will be held in a patient register and
tissue archive to be housed at Middlemore Hospital, to which the Ministry of Health (or such other person
or organisation as the Minister may nominate for the purpose) will have unrestricted access.
2. In the event that LCT ceases trading in New Zealand,
it will transfer its tissue stores and patient data relating
to the trial to the Ministry of Health.
3. All trial participants must provide written consent to their patient information and tissue samples being supplied to, held by and used for the purposes of a government-administered national patient register and tissue archive.
4. LCT is, on request, to provide to the Ministry of Health (or such other person or organisation as the Minister may nominate for the purpose) any patient information and tissue samples required for the purposes of establishing and maintaining a government-administered national patient register and tissue archive.
5. LCT will at all times comply with the procedures set
out in its documents entitled: “LCT Risk Management and Safety Monitoring Strategy and Operations for Xenotransplantation” and “ClinicaI Trial Protocol”, and seek any approvals from the appropriate regulatory authorities to vary any of these procedures and protocols.
6. The operation of the trial will be overseen by an independent Data Safety Management Board, whose membership and terms of reference will be confirmed by Medsafe.
7. All serious adverse events must be reported by LCT
to the relevant regulatory authorities (including Medsafe, the Northern X Regional Health and Disability Ethics Committee) immediately, and within 24 hours of becoming aware of the adverse event at the latest. Serious adverse events include those that result in
death, hospitalisation or time off work, and other events identified in the study protocol, including negative changes in health status, unexplained fever, or evidence of possible infection in study participants, and reports of all positive testing for infections and negative changes in health status of the pigs being used in the study. The outcome of any investigation carried out in response to an adverse event must also be reported as soon as possible to the relevant regulatory authorities.
8. Three-monthly progress reports must be made to Medsafe, or such other person or body as the Minister may nominate.
9. A final report must be provided to Medsafe within
8 weeks of the conclusion of the trial.
10 All LCT Laboratory facilities are subject to inspections from Medsafe, lnternational Accreditation New Zealand, or any person nominated by the Minister at any time during the trial, within normal working hours.
11. The authorisation is granted subject to completion of an international peer review:
(a) The Minister will inform LCT of the person selected to act as an international peer reviewer and allow LCT the option of objecting in writing to the person selected.
(b) The purpose of the peer review is to advise the Minister on the adequacy of LCT’s application and the risk management and safety procedures included in the protocol; and to make recommendations on whether any changes are required to the conditions of approval placed on the study in order to adequately manage any outstanding risk of patient harm.
(c) The peer review is to be completed within 6 weeks from the date of authorisation.
(d) LCT will co-operate fully with the peer reviewer and will provide such information as the Minister may direct, provided that information may be supplied in confidence.
(e) The Minister may implement any such recommendations by means of imposing or varying the conditions of the authorisation under sections 96C(4)(b) and (c) of the Act, but will consult with LCT before doing so.
12. LCT will, when directed by Medsafe, provide a report on their compliance with any new or amended international guidelines on xenotransplantation (including those being developed by the World Health Organization), including details of how they will amend their study, if required, to bring it into compliance.
This authorisation remains in effect for the period that the clinical trial has been approved by the Northern X Regional Health and Disability Ethics Committee, unless sooner varied or revoked, pursuant to section 96C(4) of the Medicines Act 1981.
Dated this 21st day of October 2008.
HON DAVID CUNLIFFE, Minister of Health.