1 Title
2 Commencement
Part 1General provisions
3 Purpose of this Act
4 Overview of this Act
5 Overviews of use for certain purposes of certain tissue
6 Interpretation
7 Human tissue defined and illustrated
8 How Act applies to foetal tissue not subject to Code
9 Informed consent, informed objection, and overriding objection defined
10 Close available relative defined
11 When people not available for purposes of Act
12 Responsible person defined
13 Act binds the Crown
Part 2Human tissue
Subpart 1—Requirements for informed consent for certain kinds of collection or use of human tissue
Preliminary provisions on collection or use of tissue
14 Duty of person proposing to collect or use tissue
15 Responsible person must help if consulted
16 Act does not require collection or use
17 Person justified in deciding not to collect or use tissue
18 Person collecting or using tissue must take into account cultural and spiritual needs, values, and beliefs
When informed consent required and not required
19 Collection or use for which informed consent required
20 Informed consent not required for collection or use for specified purposes
How subpart relates to other laws, etc
21 Other laws, and lawfulness of use, etc, not affected
Subpart 2—Offences relating to informed consent
Tissue that is, or is collected from, bodies
22 Collection or use without informed consent
Non-health-care tissue
23 Donor analysis, etc, without informed consent
Tissue from living individuals
24 Use for secondary purpose after donors’ deaths without informed consent
Affirmative defence and assumptions
25 Affirmative defence for informed consent offences
26 Person 16 years old or older assumed to be capable
27 Consent or objection assumed to be free and informed
28 Person assumed to have taken into account immediate family’s cultural and spiritual needs, values, and beliefs
29 When consent or objection on behalf of immediate family may be assumed to comply with section 40
30 Death does not affect consent, objection, or nomination
Subpart 3—Who is entitled to give informed consent
31 Who is entitled to give informed consent to collection or use for general purposes
32 Who is entitled to give informed consent to collection or use for anatomical examination or public display
33 Who is entitled to give informed consent to collection or use for donor analysis
34 Who is entitled to give informed consent to use for secondary purpose after donor’s death
When consent or objection treated as not given or raised for purposes of this subpart
35 Nominees do not exist or are not available, or it is not practicable to ascertain whether decision made
36 Immediate family: procedure when it is not practicable to ascertain whether decision made on its behalf
Capacity and consent or objections on behalf of another
37 Capacity to give or raise or make, etc, consent, objection, or nomination, etc
38 Consent or objection given or raised or made, etc, on behalf of another
Subpart 4—Further provisions on consent or objections by, or on behalf of, nominees, immediate family, and close available relatives
39 Nominations and consent or objections by nominees
40 Consent or objection on behalf of immediate family
41 Close available relative may raise overriding objection
Subpart 5—Process for, and form, amendment, and recording of, consent, objections, and nominations
42 Duty to take into account immediate family’s cultural and spiritual needs, values, and beliefs
43 Form of consent, objection, or nomination
44 Written consent or objection on behalf of immediate family may include details of consultation, etc
45 Amendment, etc, of consent, objection, or nomination
46 Consent, objections, nominations, etc, may be recorded in national organ and tissue donor register
Subpart 6—Other requirements for and restrictions on collection or use of human tissue
Collection or use of tissue for non-therapeutic purposes
47 Standards for collection or use of human tissue for non-therapeutic purposes
Post-mortems, official inquiries, etc
48 Restriction on collecting or using tissue if official post-mortem or inquiry directed or opened
49 Post-mortems must be performed by, or in accordance with instructions of, medical practitioners
Collection of tissue from bodies for therapeutic purposes, health practitioner education, or research
50 Collection only by qualified person after examination
Anatomical examinations and public display
51 Anatomical examination and certain public display of body of person under 16 years prohibited
52 Anatomical examinations must usually be performed at schools of anatomy
53 Anatomical examinations outside schools of anatomy
Decency to be observed, etc
54 Duty of those performing post-mortems or anatomical examinations, or collecting tissue from bodies
Trading in blood, controlled human substances, or other human tissue
55 Interpretation
56 Trading in human tissue generally prohibited
57 Collection of blood or controlled human substance
58 Consideration not generally to be provided for collection of blood or controlled human substance for administration to another person
59 Person administering blood or controlled human substance not to charge recipient for its collection or use
60 Exemptions
61 Advertising prohibited
62 Liability of employers, principals, and directors
63 Appointed entities to collect and distribute blood and controlled human substances
64 Exemption from Part 2 of Commerce Act 1986
65 Protection of appointed entities
Exportation and importation of human tissue
66 Standards, etc, for export and import of human tissue
Part 3Technical and miscellaneous provisions
Enforcement provisions
67 Matters to be ascertained by authorised persons
68 Powers of authorised persons
69 Entry of dwellinghouses and marae
70 Identification of authorised person
71 Notice requirements when place entered
72 Disposal of property seized
73 Obstructing inspections, etc, by authorised persons
Regulations and Orders in Council
74 Regulations prescribing or approving quality, safety, and other standards for collection or use of human tissue for non-therapeutic purposes
75 Regulations prescribing or approving requirements and quality, safety, and other standards for export and import of human tissue
76 Regulations may incorporate standards by reference
77 Orders authorising establishment of schools of anatomy
78 Regulations establishing or recognising national organ and tissue donor register
79 Regulations prescribing form of search warrant
Inspectors of schools of anatomy
80 Appointment
81 Term of office
82 Removal of inspectors who are not members of police
83 Directions to inspectors
84 Inspectors must report irregularities
85 Inspectors may visit and inspect school
Disclosure of health information to facilitate consideration of use of tissue for transplantation or other therapeutic purposes
86 Disclosure to ascertain medical suitability and whether consent required for use has been, or may be, given
Repeal of organ donor provisions in driver licensing legislation
87 Land Transport Act 1998 amended
28B Transitional provision for driver licences showing organ donor information about holders, etc
88 Land Transport (Driver Licensing) Rule 1999 amended
89 Commencement of sections 87 and 88
Amendment ensuring taking of tissue from live donor for transplantation, etc, is health treatment
90 Interpretation
Amendment to Human Assisted Reproductive Technology Act 2004 and relating to gametes and embryos
91 Regulations
Consequential amendments and repeals
92 Consequential amendments
93 Repeals
Savings and transitional provisions
94 Exemptions under section 92E(1) of Health Act 1956
95 Entities appointed under Health Act 1956 to collect and distribute blood and controlled human substances
96 Schools of anatomy and inspectors of them
97 Existing holdings of human tissue
Schedule 1Use for general purposes of tissue that is or is from bodies
Schedule 2Use for anatomical examination or public display of tissue that is or is from bodies
Schedule 3Use for secondary purposes after donor’s death of tissue from living individual
Schedule 4Form of search warrant
Schedule 5Incorporation of standards in regulations by reference
Schedule 6Consequential amendments
Legislative history
The Parliament of New Zealand enacts as follows: