Citation: Ministry of Health. 2004. Review of the Regulation of Human Tissue and
Tissue-based Therapies: Discussion document. Wellington: Ministry of Health.
Published in March 2004 by the
Ministry of Health
PO Box 5013, Wellington, New Zealand
ISBN 0-478-28223-0 (Book)
ISBN 0-478-28224-9 (Internet)
HP 3805
This document is available on the Ministry of Health’s website:
http://www.moh.govt.nz

[목차]

Executive Summary vi

Part A: Introducing the Review 1
A1 Goals of the Review 1
A2 Scope of the Review 2
A2.1 What is human tissue? 2
A2.2 What does the Review cover? 3
A2.3 What does the Review not cover? 3
A3 Cultural and religious perspectives 4
A3.1 Mäori issues 5
A3.2 Pacific peoples 5
A3.3 Religious groups 6

Part B: Non-Therapeutic Use of Tissue 7
B1 Non-therapeutic uses of human tissue 7
B1.1 Diagnosis and other uses as part of health care 7
B1.2 Anatomical examination 7
B1.3 Education and training 7
B1.4 Research 8
B1.5 Determining the cause of death, or gathering more information about
an illness, through a post-mortem examination 8
B1.6 Clinical audit 8
B2 Current regulation of tissue for non-therapeutic use 9
B2.1 Human Tissue Act 1964 9
B2.2 Code of Health and Disability Services Consumers’ Rights 1996 14
B2.3 Operational Standard for Ethics Committees 16
B2.4 Hazardous Substances and New Organisms Act 1996 19
B2.5 Supplementary Order Paper to the Human Assisted Reproductive
Technology Bill 20
B2.6 Health (National Cervical Screening Programme) Amendment Act
2004 21
B2.7 Health Information Privacy Code 1994 22
B2.8 Coroners Act 1988 22
B3 What are the issues, gaps and problems? 22
B4 A note about non-coronial post-mortem examinations 24
B4.1 Why is it necessary to retain tissue from a post-mortem
examination? 25
B4.2 New provisions for tissue retention at non-coronial post-mortem
examinations 25
B5 Informed consent 26
B5.1 General principles: striking the right balance 26
B5.2 Seeking consent in different circumstances 28
B5.3 Consent for children 33
B5.4 Recording consent 35
B6 Tissue management, oversight and monitoring 35
B6.1 A framework for tissue management 35
B6.2 Oversight and monitoring 37
B7 Definitions 39
B7.1 Body 39
B7.2 Lawful possession of a body for non-therapeutic purposes 39
B8 Special types of tissue 41
B8.1 Stillborn children and foetal tissue 41
B8.2 Stem cells and cell lines 43
B9 Privacy and genetic information 47
B9.1 Why is genetic information different? 47
B9.2 Protections for genetic information 48
B10 Retention of specimens as health information under the Health Act 1956
50
B10.1 Health (Retention of Health Information) Regulations 1996 51

Part C: Therapeutic Use of Tissue 54
C1 What are tissue-based therapies? 54
C1.1 Cell and tissue therapies 54
C1.2 Gene and related therapies 55
C1.3 Xenotransplantation 56
C2 Current regulation of tissue for therapeutic use 56
C2.1 Medicines Act 1981 57
C2.2 Human Tissue Act 1964 57
C2.3 Code of Health and Disability Services Consumers’ Rights 1996 59
C2.4 Hazardous Substances and New Organisms Act 1996 60
C3 What are the issues, gaps, or problems? 61
C4 Organ and tissue donation 61
C4.1 Organ and tissue donation in New Zealand 61
C4.2 Increasing the organ and tissue donor rate in New Zealand 63
C4.3 The role of legislation 64
C4.4 What are the options for changing New Zealand’s law regarding
consent to organ and tissue donation? 65
C4.5 Defining death and determining brain-death 69
C4.6 Different types of deceased donors 71
C4.7 Directed donation by deceased donors 72
C4.8 Live tissue donation 73
C4.9 Safety of whole organs that are transplanted 74
C5 Safety of tissue-based therapies 75
C5.1 Regulating services and entities that deliver tissue-based services 75
C5.2 Regulating tissue-based therapeutic products 77

Part D: Common Concerns for All Uses of Tissue 89
D1 Respect for tissue 89
D2 Definitions of who is able to give consent 89
D3 Future-proofing the legislative framework – acceptability and safety 91
D3.1 Xenotransplantation 92
D4 Sale and purchase of tissue 94
D4.1 Arguments for allowing the sale and purchase of human tissue 95
D4.2 Arguments against allowing the sale and purchase of human tissue 96
D5 Import and export of tissue 97

Part E: Looking Toward a New Regulatory Framework 100
E1 A new human tissue act 100
E2 Amendments to therapeutic products legislation 101
E3 Standards under the Health and Disability Services (Safety) Act 2001 101
E4 Health Act 1956 102
E5 Other regulations, codes or guidelines 102

Glossary 103

Appendices
Appendix 1: Relevant Provisions of the Official Information Act 106
Appendix 2: Human Tissue Act 1964 108
Appendix 3: Code of Health and Disability Services Consumers’ Rights 115
Appendix 4: Ethics Committees in New Zealand 121
Appendix 5: Part 3A of the Health Act 1956 124

References 129

List of Consultation Questions 133

List of Tables
Table B1: Decision authority over the use of tissue for anatomical
examination, education, research and non-coronial post mortem
under the Human Tissue Act 1964 11
Table B2: Principles of ethical review 17
Table B3: Framework for services safety under the Health and Disability
Services (Safety) Act 2001 38
Table B4: Framework governing the collection and use of tissues and cells
for research in New Zealand 45
Table C1: Decision authority for the collection of tissue from deceased
persons for therapeutic use under the Human Tissue Act 1964 59
Table C2: Framework for services safety under the Health and Disability
Services (Safety) Act 2001 76
Table C3: Summary of the degree of risk posed by different tissue-based
therapeutic products 86

This document is available on the Ministry of Health’s website:
http://www.moh.govt.nz