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Review of the Regulation of Human Tissue and Tissue-based Therapies
Discussion document
Date of publication: April 2004
ISBN 0-478-28223-0 (Book)
ISBN 0-478-28224-9 (Internet)
HP 3805
The review covered a large number of sensitive and interrelated issues including the:
Collection, use, retention, storage and disposal of human tissue for non-therapeutic purposes
Management, oversight and monitoring of the use of tissue for non-therapeutic purposes
Existing privacy arrangements for genetic information
Safety of tissue-based therapeutic products, including whole organs for transplantation, stored and banked tissue, and other tissue-based therapeutic products
Legislative arrangements for organ and tissue donation for therapeutic use
Regulation of the import and export of human tissue
Sale and purchase of tissue
Current controls on xenotransplantation (live animal to human transplants).
The Ministry has prepared a discussion document to facilitate feedback on the many concerns that arise in the human tissue area.
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Document availability
The discussion document covers a lot of complex and interrelated issues. For convenience it has been broken into sections below.
You may also download the whole document if you wish.
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download the full text of the discussion document in PDF format (pdf, 596.74 kB)
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download it in Word format (doc, 747.50 kB)
Document broken into sections:
Table of contents (pdf, 604.92 kB)
Executive Summary (pdf, 606.09 kB)
Part A: Introducing the Review (pdf, 72.32 kB)
This includes the goals and scope of the review, important definitions, and cultural and religious perspectives.
Part B: Non-therapeutic use of tissue (pdf, 247.56 kB)
The non-therapeutic uses of tissue are anatomical examination, post-mortem examination, research, and education.
This part describes current regulations and then discusses informed consent, tissue management, oversight and monitoring, stillborn children and foetal tissue, stem cells, genetic information, and the application of the Health (Retention of Health Information) Regulations 1996 to tissue specimens.
Part C: Therapeutic use of tissue (pdf, 191.40 kB)
This Part discusses issues related to when tissue is used as a therapeutic product. It describes the different types of tissue-based therapies and current regulations.
It then discusses organ and tissue donation (including the legislation governing consent, brain-death, non-heartbeating donation, live donation, and safety matters), the regulation of banked tissue, and the regulation of other tissue-based therapies.
Part D: Common concerns for all uses of tissue (pdf, 108.56 kB)
This Part covers a number of matters that are common to both therapeutic and non-therapeutic uses of tissue.
Topics covered are:
respect for tissue,
definitions of who can give consent,
future-proofing the new legislation (including xenotransplantation),
the sale and purchase of tissue, and
the import and export of tissue.
Part E: Looking toward a new regulatory framework (pdf, 57.23 kB)
This part provides a high level summary of what the new legislative framework may look like.
Glossary (pdf, 58.05 kB)
Appendix 1: Relevant provisions of the Official Information Act (pdf, 53.56 kB)
Appendix 2: Human Tissue Act 1964 (pdf, 68.25 kB)
Appendix 3: Code of health and Disability Services Consumers’ Rights (pdf, 64.84 kB)
Appendix 4: Ethics committees in New Zealand (pdf, 76.30 kB)
Appendix 5: Part 3A of the Health Act 1956 (pdf, 66.31 kB)
References (pdf, 86.96 kB)
Consultation questions (pdf, 94.94 kB)
Related information
Human Tissue
Current consultation documents