National Health Committee’s Advice on Living Cell Technologies Application for Xenotransplantation Clinical Trials in New Zealand

National Health Committee’s Advice on Living Cell Technologies Application for Xenotransplantation Clinical Trials in New Zealand

Date of publication: October 2008

Summary of publication

On 20 June 2008, the Minister of Health wrote to the National Health Committee (NHC) requesting that the NHC provide him with independent advice on the application that has been made by Living Cell Technologies (LCT) to conduct clinical trials of pig cell transplantation in New Zealand. The request was made in accordance with section 96E(3) of the Medicines Act 1981 which enables the Minister to seek advice from appropriately qualified persons on the application. The NHC was asked to provide advice in terms of all the criteria under section 96E(1) of the Medicines Act (1981).

The Minister asked the NHC to provide him with advice by 8 August 2008. This report, sets out that advice and the process the NHC undertook to develop it.

Part One

Part One of this report provides the Minister with advice within the scope of the request in terms of the legislative criteria under the Medicines Act. It deals with all matters that are relevant to the decision the Minister will make on the application. The NHC notes that the criteria under which this particular application is assessed are circumscribed by the legislation and only relevant issues are considered within this first part of the report.

The core of Part One is the Summary of Advice in section 1.4, followed by a fuller discussion in Chapter 2. Supporting information for Part One is contained in Chapter 3, which provides background context for this trial application, Chapter 4, which describes the process the application went through prior to the NHC’s involvement, and Chapter 5, which provides more information related to the NHC’s consideration of the application.

Part Two

Part Two of this report is contained in Chapter 6, and covers a number of wider and related issues that have come to the NHC’s attention in the course of doing this work. While they are not directly relevant to the Minister’s decision on this application by LCT, the NHC considers they are important matters for the Minister to be aware of in terms of the wider policy context for xenotransplantation.

Related information

Minister's media release: Living Cell Technologies trial approved - www.beehive.govt.nz (21 October 2008)

Download this publication in Word and PDF format

National Health Committee’s Advice on Living Cell Technologies Application for Xenotransplantation Clinical Trials in New Zealand (PDF, 750 KB)

National Health Committee's Advice on Living Cell Technologies Application for Xenotransplantation Clinical Trials in New Zealand (Word, 826 KB)

Information about downloading publications

Page last updated: 21 October 2008