Human Tissue Act 2008

1: Title
This Act is the Human Tissue Act 2008.
2: Commencement
1: Sections 1 2 89
2: Sections 87 88 section 87 section 89
3: The rest of this Act comes into force on a date to be appointed by the Governor-General by Order in Council.
4: An order under this section is secondary legislation ( see Part 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 2(3) brought into force 1 November 2008 clause 2 Human Tissue Act 2008 Commencement Order 2008 Section 2(4) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
1: General provisions
3: Purpose of this Act
The purpose of this Act is to help to ensure that collection or use of human tissue—
a: occurs only with proper recognition of, and respect for,—
i: the autonomy and dignity of the individual whose tissue is, before or after his or her death, collected or used; and
ii: the cultural and spiritual needs, values, and beliefs of the immediate family of that individual; and
iii: the cultural, ethical, and spiritual implications of the collection or use of human tissue; and
iv: the public good associated with collection or use of human tissue (whether for health practitioner education, the investigation of offences, research, transplantation or other therapeutic purposes, or for other lawful purposes); and
b: does not endanger the health and safety of members of the public; and
c: generally does not involve the requirement or acceptance, or the offering or provision, of financial or other consideration for the tissue.
4: Overview of this Act
1: To help to achieve its purpose, this Act—
a: requires, unless they are done for a purpose specified in section 20
i: collection or use of human tissue that is, or is collected from, a body:
ii: collection of non-health-care tissue for donor analysis:
iii: donor analysis of non-health-care tissue:
iv: use for a secondary purpose, after the donor’s death, of human tissue collected from a living individual; and
b: makes it an offence to collect or use tissue if the informed consent required has not been given; and
c: imposes other requirements for and restrictions on collection or use of human tissue; and
d: provides for related matters; and
e: repeals and replaces (with modified provisions)—
i: the Human Tissue Act 1964
ii: Part 3A
2: This section is intended as a guide only.
5: Overviews of use for certain purposes of certain tissue
1: A diagrammatic overview of use for general purposes of tissue that is or is from bodies is set out in Schedule 1
2: A diagrammatic overview of use for anatomical examination or public display of tissue that is or is from bodies is set out in Schedule 2
3: A diagrammatic overview of use for secondary purposes after the donor’s death of tissue from a living individual is set out in Schedule 3
4: The diagrams are intended as a guide only.
6: Interpretation
In this Act, unless the context otherwise requires,— anatomical examination associate coroner Coroners Act 2006 authorised person body capable
a: understand the nature, and foresee the consequences, of the decision; and
b: communicate the decision close available relative section 10 Code section 74(1) collect consumer section 2(1) controlled drug Misuse of Drugs Act 1975 coroner Coroners Act 2006 dead foetus
a: the umbilical cord has been severed:
b: the placenta has detached:
c: the foetus has issued completely from its mother Director-General Public Service Act 2020 donor analysis embryo ethics committee
a: established by, or appointed under, an enactment; or
b: approved by the Director-General exportation section 5(1) gamete
a: an egg or a sperm, whether mature or not; or
b: any other cell (whether naturally occurring or artificially formed or modified) that—
i: contains only 1 copy of all or most chromosomes; and
ii: is capable of being used for reproductive purposes head health care procedure section 2(1) health practitioner section 5(1) human tissue tissue section 7 immediate family
a: means members of the individual’s family, whānau, or other culturally recognised family group, who—
i: were in a close relationship with the individual; or
ii: had, in accordance with customs or traditions of the community of which the individual was part, responsibility for the individual’s welfare and best interests; and
b: to avoid doubt, includes a person whose relationship to the dead individual was, or was a relationship that is established through, 1 or more of the following relationships:
i: spouse, civil union partner, or de facto partner of the individual:
ii: child, parent, guardian, grandparent, brother, or sister of the individual:
iii: stepchild, step-parent, stepbrother, or stepsister of the individual importation section 5(1) informed consent section 9 informed objection section 9 inspector section 80 marae medical practitioner section 114(1)(a) medicine Medicines Act 1981 Minister national organ and tissue donor register section 78 nomination section 39 nominee section 39 non-health-care tissue
a: collected from a consumer in the course of a health care procedure; nor
b: derived from human tissue collected in that way other donor information
a: a request by a person that his or her body or any specified part of his or her body be used after his or her death for therapeutic purposes or for purposes of health practitioner education or any kind of research; and
b: information (referred to in the Land Transport Act 1998 overriding objection section 9 post-mortem Registrar the District Court responsible person section 12 school of anatomy section 77 secondary purpose
a: to the collection or use, by any person, and for identified purposes, of tissue collected from that living individual or tissue that is, or is collected from, the body; and
b: given, and not later revoked, in accordance with the requirements of this Act use
a: includes—
i: the performance of a post-mortem involving that tissue; and
ii: research using that tissue; and
iii: anatomical examination and public display of that tissue; and
iv: testing (including donor analysis) of that tissue; and
v: storage of that tissue; and
vi: disposal of that tissue; and
b: in particular, includes use of that tissue in the development, making or preparation, and testing of controlled drugs, medicines, or both; and
c: includes, whether or not that tissue is non-health-care tissue, and except as provided in paragraph (e), the use of that tissue (for example, the administration or transplantation of that tissue) in the carrying out of a health-care procedure; and
d: includes, except as provided in paragraphs (e) and (f), use of that tissue for a secondary purpose; but
e: does not include use of that tissue in so far as it is, or is part of, a controlled drug, a medicine, or both; and
f: does not include the importation or the exportation of that tissue. Section 6 associate coroner inserted 5 April 2023 section 36 Coroners Amendment Act 2023 Section 6 coroner inserted 5 April 2023 section 36 Coroners Amendment Act 2023 Section 6 Director-General amended 7 August 2020 section 135 Public Service Act 2020 Section 6 exportation amended 1 October 2018 section 443(3) Customs and Excise Act 2018 Section 6 importation amended 1 October 2018 section 443(3) Customs and Excise Act 2018 Section 6 Registrar amended 1 March 2017 section 261 District Court Act 2016
7: Human tissue defined and illustrated
1: Human tissue tissue
a: is, or is derived from, a body, or material collected from a living individual or from a body; and
b: is or includes human cells; and
c: is not excluded, for the purposes of some or all of the provisions of this Act, by subsection (2) or (3).
2: A human embryo or human gamete is not human tissue for the purposes of any provision of this Act.
3: Cell lines derived from human cells are human tissue for the purposes of the following sections, but not for the purposes of any other provisions of this Act:
a: sections 47 74
b: sections 66 75
4: Examples of human tissue therefore include the following:
a: all or any part of a body:
b: whole human organs (for example, hearts, kidneys, livers, and lungs) or parts of them (for example, heart valves):
c: human stem cells or other human cells (for example, stem cells obtained from human embryos):
d: human blood:
e: human bone marrow:
f: human eyes:
g: human hair, nails, and skin:
h: human lung washouts:
i: human mucus, sputum, or urine.
8: How Act applies to foetal tissue not subject to Code
Human tissue that is, or is part of, a dead foetus and is not collected from a consumer in the course of a health care procedure must, for the purposes of this Act, be treated,—
a: if the dead foetus did not issue completely from its mother before she died (because of its miscarriage or for any other reason), as tissue that is, or is collected from, the body of the mother of the dead foetus; and
b: if the dead foetus issued completely from its mother (whether or not she died because of its having issued), as tissue that is, or is from, the body of an individual who is not the mother and did not, before death, give, or nominate any person to give on his or her behalf, informed consent to use of tissue that is, or is collected from, his or her body.
9: Informed consent, informed objection, and overriding objection defined
1: Informed consent
a: to that kind of collection or use of the tissue (and so does not include agreement in general terms, given by an applicant for, or holder of, a driver licence, to that applicant or holder being an organ donor); and
b: given by a person who is entitled to give it under subpart 3
c: given freely, and in the light of all information that a reasonable person, in that person’s circumstances, needed in order to give informed consent; and
d: given in accordance with the requirements of subparts 4 5
e: not later revoked in accordance with the requirements of subparts 4 5
2: Informed objection
a: to that kind of collection or use of the tissue (and so does not include any objection in general terms, raised by an applicant for, or holder of, a driver licence, to that applicant or holder being an organ donor); and
b: raised by a person who is entitled to raise it under subpart 3
c: raised freely, and in the light of all information that a reasonable person, in that person’s circumstances, needed in order to raise an informed objection; and
d: raised in accordance with the requirements of subparts 4 5
e: not later revoked in accordance with the requirements of subparts 4 5
3: Overriding objection
a: to that kind of collection or use of the tissue; and
b: raised under section 41 section 10(1)
c: raised freely, and in the light of all information that a reasonable person, in that person’s circumstances, needed in order to raise an overriding objection; and
d: raised in accordance with the requirements of subparts 4 5
e: not later revoked in accordance with the requirements of subparts 4 5
10: Close available relative defined
1: A close available relative
a: a person who was a spouse, civil union partner, or de facto partner of the individual immediately before his or her death; or
b: if the individual, immediately before his or her death, had no spouse, civil union partner, or de facto partner, or if no person who was then the individual’s spouse, civil union partner, or de facto partner is available, a son or daughter—
i: of the individual; and
ii: who is 16 years old or older; or
c: if no person referred to in paragraph (a) or (b) is available, a parent of the individual; or
d: if no person referred to in paragraphs (a) to (c) is available, a brother or sister—
i: of the individual; and
ii: who is 16 years old or older.
2: A close available relative
a: a parent of the individual; or
b: if a parent of the individual is not available, a person who was a guardian of the individual immediately before his or her death; or
c: if no person referred to in paragraph (a) or (b) is available, a brother or sister—
i: of the individual; and
ii: who is 16 years old or older.
11: When people not available for purposes of Act
A person who is dead, unknown, or missing, or not capable, must be treated for the purposes of this Act as not available.
12: Responsible person defined
1: Responsible person
2: The person specified in a paragraph of this subsection is, for the purposes of subsection (1), the person lawfully in possession of a body of the kind specified in that paragraph:
a: the person for the time being in charge of a hospital care institution as defined in section 58(4)
b: the person for the time being in charge of a hospital as defined in section 2(1)
i: the body of a patient (as so defined); and
ii: lying in the hospital:
c: the person for the time being in charge of a secure facility as defined in section 5(1)
i: the body of a person who was required to stay in the facility; and
ii: lying in the facility:
d: the prison manager of a prison (as those terms are defined in section 3(1)
i: the body of a prisoner (as so defined); and
ii: lying in the prison:
e: the head of a school of anatomy—a body that is—
i: received and possessed by the school for anatomical examination; and
ii: lying in the school.
3: Subsection (2) does not limit the rights, powers, or duties of any person entitled under any rule of law to the possession of a body.
4: Possession 1964 No 19 ss 2(2) 3(6)
13: Act binds the Crown
This Act binds the Crown.
2: Human tissue
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
1: A person who proposes to collect or use human tissue must, before collecting or using the tissue, take all reasonably practicable steps to ascertain—
a: what informed consent (if any) is required by this Act for the proposed collection or use of that tissue; and
b: whether informed consent required by this Act for that collection or use of the tissue has been given; and
c: if informed consent of that kind has been given, whether it is overridden by an overriding objection to that collection or use of the tissue.
2: If the tissue proposed to be collected or used is tissue that is, or is collected from, a body, the steps required by subsection (1) include, if and so far as they are reasonably practicable,—
a: consulting the responsible person; and
b: ascertaining whether the national organ and tissue donor register includes any relevant informed consent or informed objection.
15: Responsible person must help if consulted
The responsible person must, if consulted under section 14(2)(a)
16: Act does not require collection or use
Nothing in this Act requires any person to collect or use human tissue.
17: Person justified in deciding not to collect or use tissue
A person who proposes to collect or use human tissue is justified in deciding not to do so if satisfied, based on all information available to the person in the circumstances, that any informed consent for the collection or use of that tissue should for any reason not be acted on.
18: Person collecting or using tissue must take into account cultural and spiritual needs, values, and beliefs
A person collecting or using human tissue must take into account, so far as they are known to the person based on information available to the person in the circumstances, the cultural and spiritual needs, values, and beliefs of the immediate family of the individual whose tissue is collected or used. When informed consent required and not required
19: Collection or use for which informed consent required
1: The following, if done, must be done with informed consent:
a: collection or use of human tissue that is, or is collected from, a body:
b: collection of non-health-care tissue for donor analysis:
c: donor analysis of non-health-care tissue:
d: use for a secondary purpose, after the donor’s death, of human tissue collected from a living individual.
2: Subsection (1) does not apply to collection or use—
a: for a purpose specified in section 20
b: for a purpose that is an offence against, or prohibited by, any law (other than sections 22 23 24
3: An example of collection or use of the kind referred to in subsection (2)(b) is any collection or use that is an improper or indecent interference with, or offering of an indignity to, any dead human body or human remains, whether buried or not, contrary to section 150(b)
20: Informed consent not required for collection or use for specified purposes
Informed consent is not required for collection or use of human tissue for any of the following purposes:
a: the exercise by a person of that person’s powers under any law to collect or use tissue without consent, including (without limitation) powers of that kind exercised for either of the following purposes:
i: the maintenance of the law, including the prevention, detection, investigation, prosecution, or punishment of offences; or
ii: the protection of the health or safety of members of the public:
b: the implementation, by using non-health-care tissue for donor analysis, of a direction or order of a court or tribunal:
c: the provision, for the medical benefit of another person or a child conceived but not born, and by using non-health-care tissue for donor analysis, of information about the individual from whom the non-health-care tissue was collected or derived, if—
i: it is not reasonably practicable to find that individual or, if he or she has died, a personal representative or family member of that individual; and
ii: all reasonable efforts have been made to ascertain whether that individual objected to the tissue being used for those purposes, and he or she appears not to have done so:
d: the performance of a post-mortem of a body that one of the following competent legal authorities has, under one of the following enactments, directed or ordered to be performed:
i: a coroner acting under section 31
ii: the High Court acting under section 41
iii: the Director-General of Health acting under section 78
e: the carrying out, by using for a secondary purpose tissue that is a body or is collected from a living individual or a body, or by using non-health-care tissue for donor analysis, of research that has received the approval of an ethics committee (even though the ethics committee knew that informed consent had not been, and would not be, obtained for the research):
f: the carrying out, to assure or improve the quality of services, and by using for a secondary purpose tissue that is a body or is collected from a living individual or a body, or by using non-health-care tissue for donor analysis, of all or any of the following activities:
i: a professionally recognised quality assurance programme:
ii: an external audit of services:
iii: an external evaluation of services:
g: the testing or disposal of tissue that is a body or is collected from a living individual or a body, because—
i: that testing or disposal is or may be necessary to avoid endangering the health or safety of members of the public; or
ii: that disposal is necessary or desirable because all reasonable attempts have been made, but have failed, to return the tissue to a family member or other person to whom the tissue would otherwise be returned for disposal:
h: display by or on behalf of the responsible person and to enable people to pay their final respects to, or that is incidental to the funeral of, the dead individual:
i: burial, cremation, or other lawful disposal, by or on behalf of the responsible person, of the tissue concerned. How subpart relates to other laws, etc
21: Other laws, and lawfulness of use, etc, not affected
Nothing in this subpart—
a: limits or affects any provision of subpart 6 Part 3
b: makes unlawful collection or use of human tissue for a particular purpose if collection or use of tissue for that purpose is lawful apart from this subpart; or
c: makes lawful collection or use of human tissue for a particular purpose if collection or use of tissue for that purpose is unlawful apart from this subpart. 1964 No 19 ss 3(3), (7) 7(2)
2: Offences relating to informed consent
Tissue that is, or is collected from, bodies
22: Collection or use without informed consent
1: A person commits an offence, and is liable on
a: the person collects or uses human tissue that is, or is collected from, a body; and
b: informed consent is required by subpart 1
2: The penalty referred to in subsection (1) is,—
a: if that collection or use is for a secondary purpose, imprisonment for a term not exceeding 3 months or a fine not exceeding $20,000; and
b: in every other case, imprisonment for a term not exceeding 1 year or a fine not exceeding $50,000. Section 22(1) amended 1 July 2013 section 413 Criminal Procedure Act 2011 Non-health-care tissue
23: Donor analysis, etc, without informed consent
A person commits an offence, and is liable on
a: the person collects non-health-care tissue for donor analysis or carries out donor analysis of non-health-care tissue; and
b: informed consent is required by subpart 1 Section 23 amended 1 July 2013 section 413 Criminal Procedure Act 2011 Tissue from living individuals
24: Use for secondary purpose after donors’ deaths without informed consent
A person commits an offence, and is liable on
a: the person uses for a secondary purpose, after the donor’s death, human tissue from a living individual; and
b: informed consent is required by subpart 1 Section 24 amended 1 July 2013 section 413 Criminal Procedure Act 2011 Affirmative defence and assumptions
25: Affirmative defence for informed consent offences
It is a defence in a prosecution for an offence against section 22 23 24
a: informed consent was not required by subpart 1
b: informed consent was required by subpart 1
26: Person 16 years old or older assumed to be capable
A person who proposes to collect or use human tissue is, unless that person is aware of evidence to the contrary, entitled to assume that a person who is 16 years old or older is capable. 1988 No 4 s 5 SR 1996/78 r 2 Schedule, right 7(2)
27: Consent or objection assumed to be free and informed
A person who proposes to collect or use human tissue is, unless that person is aware of evidence to the contrary, entitled to assume that consent or an objection given or raised by a person has been given or raised by that person freely, and in the light of all information that a reasonable person, in that person’s circumstances, needed in order to give informed consent or to raise an informed objection or overriding objection.
28: Person assumed to have taken into account immediate family’s cultural and spiritual needs, values, and beliefs
A person who proposes to collect or use human tissue is, unless that person is aware of evidence to the contrary, entitled to assume that a person giving informed consent or raising an informed objection or overriding objection has complied with section 42
29: When consent or objection on behalf of immediate family may be assumed to comply with section 40
A person who proposes to collect or use human tissue is entitled to assume that informed consent given, or an informed objection raised, to the collection or use, by a member of an immediate family, and on its behalf, has been given or raised in accordance with section 40
a: the member has taken the steps to consult required by section 40(a)
b: the member has formed the belief, and that belief is based on the reasonable grounds, required by section 40(c)
30: Death does not affect consent, objection, or nomination
The death of a person does not affect the validity of any informed consent given, informed objection or overriding objection raised, or nomination made, by that person.
3: Who is entitled to give informed consent
Tissue that is, or is collected from, bodies
31: Who is entitled to give informed consent to collection or use for general purposes
1: This section applies to informed consent to collection or use, for any purpose that is not anatomical examination, public display, or both, of human tissue that is, or is collected from, a body.
2: Informed consent to which this section applies may only be given by the following people in the following circumstances:
a: the individual whose body is the tissue, or from whose body the tissue concerned is collected, and before his or her death:
b: that individual’s nominee or nominees, on behalf of that individual and after his or her death, if—
i: no consent has been given under paragraph (a); and
ii: no informed objection has been raised by that individual:
c: a member of that individual’s immediate family and on its behalf after that individual’s death, if—
i: no consent has been given under paragraph (b); and
ii: no informed objection has been raised by that individual’s nominee or nominees:
d: a close available relative of that individual after his or her death, if—
i: no consent has been given under paragraph (c); and
ii: no informed objection has been raised on behalf of that individual’s immediate family. Human Tissue Act 1983 s 23 (NSW); Human Tissue Act 2004 ss 2, 3, 54(9) (UK); Transplantation and Anatomy Act 1978 ss 27, 28 (ACT)
32: Who is entitled to give informed consent to collection or use for anatomical examination or public display
1: This section applies to informed consent to collection or use for anatomical examination, public display, or both, of human tissue that is, or is collected from, a body.
2: Informed consent to which this section applies—
a: may only be given under subsections (3) and (4); and
b: is, if given under 1 of those subsections, invalid unless consent has also been given under the other.
3: Informed consent to which this section applies may be given by the following people in the following circumstances:
a: the individual whose body is the tissue, or from whose body the tissue concerned is collected, and before his or her death:
b: that individual’s nominee or nominees on behalf of that individual and after his or her death, if—
i: no consent has been given under paragraph (a); and
ii: no informed objection has been raised by that individual.
4: Informed consent to which this section applies may be given by the following people in the following circumstances:
a: a member of the immediate family of the individual referred to in subsection (3)(a) and on its behalf after that individual’s death:
b: a close available relative of that individual after his or her death, if—
i: no consent has been given under paragraph (a); and
ii: no informed objection has been raised on behalf of that individual’s immediate family. Human Tissue Act 1983 s 23 (NSW); Human Tissue Act 2004 ss 2, 3, 54(9) (UK); Transplantation and Anatomy Act 1978 ss 27, 28 (ACT) Non-health-care tissue
33: Who is entitled to give informed consent to collection or use for donor analysis
1: This section applies to informed consent to collection of non-health-care tissue for donor analysis, carrying out of donor analysis of non-health-care tissue, or both.
2: Informed consent to which this section applies may only be given by the individual from whom the tissue concerned was collected or derived.
3: This section does not limit section 34 Tissue from living individuals
34: Who is entitled to give informed consent to use for secondary purpose after donor’s death
1: This section applies to informed consent to use for a secondary purpose, after the donor’s death, of human tissue from a living individual.
2: Informed consent to which this section applies may only be given by the following people in the following circumstances:
a: a member of the immediate family of the individual referred to in subsection (1) and on its behalf after that individual’s death, if no informed objection has been raised by that individual:
b: a close available relative of that individual after his or her death, if—
i: no informed consent has been given under paragraph (a); and
ii: no informed objection has been raised on behalf of that individual’s immediate family. 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
Informed consent or an informed objection must, for the purposes of sections 31 32
a: there are no nominees of the individual, or no nominees of the individual will be available before the latest time that the tissue can be collected or used; or
b: it is not practicable, before the latest time that the tissue can be collected or used, to ascertain whether the nominee or nominees of the individual have given informed consent or raised an informed objection to the collection or use proposed. Human Tissue Act 2004 ss 3(7), (8) (UK)
36: Immediate family: procedure when it is not practicable to ascertain whether decision made on its behalf
Informed consent or an informed objection must, for the purposes of sections 31 32 34 Human Tissue Act 2004 ss 3(7), (8) (UK) Capacity and consent or objections on behalf of another
37: Capacity to give or raise or make, etc, consent, objection, or nomination, etc
1: An individual who is not capable cannot give, raise, make, amend, revoke, revoke and replace, or accept or disagree with informed consent, an informed objection, an overriding objection, or a nomination.
2: An individual who is under 16 years of age—
a: may, if capable, give, amend, revoke, or revoke and replace informed consent for collection of non-health-care tissue for donor analysis, carrying out of donor analysis of non-health-care tissue, or both; but
b: cannot give, raise, make, amend, revoke, revoke and replace, or accept or disagree with any other kind of informed consent, or an informed objection, an overriding objection, or a nomination. 1988 No 4 s 5
38: Consent or objection given or raised or made, etc, on behalf of another
1: This section applies to an individual who is entitled under section 31 32 33 34
2: Informed consent or an informed objection or overriding objection in respect of an individual to whom this section applies may, whether or not that individual is capable, be given or raised, amended, revoked, or revoked and replaced by any person who is, under a law other than this Act, entitled to give consent on that individual’s behalf.
3: Persons who may be authorised, under a law other than this Act, to give consent on that individual’s behalf include—
a: a parent or legal guardian of that individual; and
b: a welfare guardian of that individual appointed under the Protection of Personal and Property Rights Act 1988
c: an attorney appointed by that individual under a power of attorney described in section 95
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
1: An individual may, for the purposes of this Act, nominate 1 or more nominees if the individual is, under section 31(2)(a) 32(3)(a)
2: A nomination in respect of an individual to whom subsection (1) applies may, whether or not that individual is capable, be made, amended, revoked, or revoked and replaced by any person who is, under a law other than this Act, entitled to give consent on that individual’s behalf.
3: Section 38(3)
4: A nomination must be made with the nominee’s written consent, and can be ended at any time by the nominee giving written notice to that effect to the individual.
5: A nomination of 2 or more nominees, or that results in 2 or more nominees, must, unless the nomination provides otherwise, be treated as requiring—
a: any informed consent to be given by all of the 2 or more nominees who are available and willing to decide whether to give informed consent; and
b: any informed objection to be raised by any or all of the 2 or more nominees who are available and willing to decide whether to raise an informed objection.
40: Consent or objection on behalf of immediate family
A member of an individual’s immediate family may only give informed consent, or raise an informed objection, under subpart 3
a: takes all reasonably practicable steps to consult members of that immediate family who represent all of the different interests (if any) of that immediate family; and
b: takes those steps with a view to achieving general agreement on the matter; and
c: after taking those steps, believes on reasonable grounds that all capable members of that immediate family accept, or would, if consulted personally, accept, that member’s giving informed consent or raising an informed objection to that collection or use on behalf of that immediate family.
41: Close available relative may raise overriding objection
1: This section applies if a close available relative has given informed consent to—
a: any collection or use of tissue that is, or is from, the body of a dead individual; or
b: any use for a secondary purpose of tissue that is from a living individual.
2: An objection to that collection or use, or to that use for a secondary purpose, of that tissue, may be raised by a person referred to in the paragraph of section 10(1) or (2)
3: For the purposes of sections 14 22 24 25
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
A person giving informed consent or raising an informed objection or overriding objection must take into account, so far as they are known to the person based on information available to the person in the circumstances, and decide what weight the person wishes to give to, the cultural and spiritual needs, values, and beliefs of the immediate family of the individual whose tissue is, or is not, to be collected.
43: Form of consent, objection, or nomination
1: Any informed consent, informed objection, overriding objection or nomination given or raised or made for the purposes of this Act must be given or raised or made either—
a: in writing (with or without witnesses); or
b: orally and in the presence of 2 or more witnesses present at the same time.
2: Without limiting subsection (1), any informed consent, informed objection, or nomination may be contained in a person’s will if that consent, objection, or nomination relates to tissue that is, or is from, the person’s body.
3: For the purposes of this section,—
a: will Wills Act 2007
b: it does not matter whether a will is valid (as defined in section 7 Human Tissue Act 2004 s 3(5)(c) (UK)
44: Written consent or objection on behalf of immediate family may include details of consultation, etc
Informed consent or an informed objection given or raised in writing, in accordance with section 43(1)(a) section 40
a: the steps taken to consult required by section 40(a)
b: the grounds for the belief required by section 40(c)
45: Amendment, etc, of consent, objection, or nomination
1: Informed consent or an informed objection, overriding objection, or nomination given, raised, or made under this Act may be amended, revoked, or revoked and replaced in the same way as it may be given, raised, or made.
2: Informed consent given by an individual to collection or use of tissue must be treated as revoked if that individual, without revoking the informed consent, later raises an informed objection to that collection or use.
46: Consent, objections, nominations, etc, may be recorded in national organ and tissue donor register
1: Nothing in this Act prevents informed consent or an informed objection or nomination (whether or not it is given, raised, or made in the form required by section 43
2: Informed consent or an informed objection or nomination is not in any way invalid or without effect just because it is not recorded in the national organ and tissue donor register.
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
1: A person collecting or using human tissue for non-therapeutic purposes must comply with all relevant quality, safety, and other standards prescribed or approved by regulations under section 74
2: This section applies even if the collection or use of the tissue is required, permitted, or otherwise controlled by law.
3: A person commits an offence, and is liable on
a: the person intentionally or knowingly collects or uses human tissue for a purpose (whether or not the person knows the purpose is a non-therapeutic purpose); and
b: that act or omission contravenes subsection (1). Section 47(3) amended 1 July 2013 section 413 Criminal Procedure Act 2011 Post-mortems, official inquiries, etc
48: Restriction on collecting or using tissue if official post-mortem or inquiry directed or opened
1: This section applies to a person and a body if the person proposes to collect or use tissue that is, or is from, the body, and the person knows, or ought reasonably to know,—
a: that a coroner has directed a pathologist to perform a post-mortem of the body, opened an inquiry into the death concerned, or both, or may do either or both; or
b: that another competent legal authority specified in section 20(d)
c: that both paragraphs (a) and (b) apply.
2: The person may collect or use, in accordance with any informed consent required by this Act, tissue that is, or is from, the body, only with the approval of the coroner or other competent legal authority concerned.
3: A person commits an offence, and is liable on
a: the person intentionally or knowingly collects or uses tissue that is, or is from, a body, and the person knows, or ought reasonably to know, what is specified in subsection (1)(a), (b), or (c); and
b: that act contravenes subsection (2). 1964 No 19 s 3(5) Section 48(3) amended 1 July 2013 section 413 Criminal Procedure Act 2011
49: Post-mortems must be performed by, or in accordance with instructions of, medical practitioners
1: Every post-mortem must be performed by, or in accordance with the instructions of, a medical practitioner.
2: A medical practitioner does not contravene subsection (1) merely by acting under a direction or order of—
a: a coroner acting under section 31
b: the High Court acting under section 41
c: the Director-General of Health acting under section 78
3: A person commits an offence, and is liable on
a: the person intentionally or knowingly does an act; and
b: that act contravenes subsection (1). 1964 No 19 ss 4(2) 12(a) Section 49(3) amended 1 July 2013 section 413 Criminal Procedure Act 2011 Collection of tissue from bodies for therapeutic purposes, health practitioner education, or research
50: Collection only by qualified person after examination
1: A person who is not a qualified person must not collect human tissue that is, or is collected from, a body if that tissue is collected for use for therapeutic purposes or for health practitioner education or any kind of research.
2: A qualified person must not collect human tissue that is, or is collected from, a body if that tissue is collected for use for all or any of those purposes unless the qualified person is satisfied, by personal examination of the body, that the individual concerned is dead.
3: Qualified person
a: a person who is, or is acting under the supervision of, a medical practitioner collecting the tissue for the purposes of the practice of his or her profession:
b: a person authorised in writing by or on behalf of the New Zealand Blood Service, the New Zealand National Eye Bank, or a body that is a successor to that Service or Bank, as suitably qualified to collect tissue of that kind for the purposes of that Service, Bank, or successor body:
c: a person who the Director-General has, by notice in the Gazette
4: A person commits an offence, and is liable on
a: the person intentionally or knowingly collects human tissue that the person knows is tissue that is, or is collected from, a body (whether or not the person knows that the tissue is collected for all or any of the purposes specified in subsection (1)); and
b: that act contravenes subsection (1) or (2). 1964 No 19 s 3(4) Section 50(4) amended 1 July 2013 section 413 Criminal Procedure Act 2011 Anatomical examinations and public display
51: Anatomical examination and certain public display of body of person under 16 years prohibited
1: No person may collect or use for anatomical examination, public display, or both, tissue that is, or is collected from, the body of an individual who, at the time he or she died, was under 16 years of age.
2: A person commits an offence, and is liable on
a: the person intentionally or knowingly does an act; and
b: that act contravenes subsection (1).
3: Subsection (1) does not apply to public display by or on behalf of the responsible person and to enable people to pay their final respects to, or that is incidental to the funeral of, the dead individual. Section 51(2) amended 1 July 2013 section 413 Criminal Procedure Act 2011
52: Anatomical examinations must usually be performed at schools of anatomy
1: A person must not, unless authorised by section 53
2: A person commits an offence, and is liable on
a: the person intentionally or knowingly does an act; and
b: that act contravenes subsection (1). 1964 No 19 ss 7(2) 12(b), (c) Section 52(2) amended 1 July 2013 section 413 Criminal Procedure Act 2011
53: Anatomical examinations outside schools of anatomy
1: All or a part of a body may be removed by or on behalf of a person to a place outside a school of anatomy for the purpose of practising anatomy, and the body or part may be received, possessed, stored, and otherwise used at that place for that purpose by or on behalf of the person, if the person—
a: is authorised by a school of anatomy to practise anatomy at that school; and
b: has written permission from the school’s head to do so; and
c: takes all reasonable steps to ensure compliance with all terms and conditions (if any) that the school’s head thought fit to impose in giving his or her written permission for that purpose.
2: Practise anatomy 1964 No 19 s 7(3) Decency to be observed, etc
54: Duty of those performing post-mortems or anatomical examinations, or collecting tissue from bodies
A person who performs a post-mortem or anatomical examination, or collects tissue that is, or is collected from, a body, under this Act, must—
a: do so in a manner that avoids unnecessary mutilation of the body that is being collected or examined, or from which the collection is being effected; and
b: conduct the examination or collection in an orderly, quiet, and decent manner. 1964 No 19 s 11 Trading in blood, controlled human substances, or other human tissue
55: Interpretation
1: In sections 57 to 65 appointed entity section 63 blood
a: includes the following:
i: a substance derived from blood:
ii: a human organ, or human bone marrow, or human tissue, including the placenta, of a kind that is suitable as a source from which to derive a constituent of blood that may be used therapeutically or in the preparation of a substance for therapeutic use:
iii: a constituent of an organ, bone marrow, or tissue described in subparagraph (ii):
iv: human haematopoietic stem cells, or a constituent of human haematopoietic stem cells, that may be used therapeutically or in the preparation of a substance for therapeutic use:
b: does not include the following:
i: any substance derived from blood, a human organ, human bone marrow, human tissue, or human haematopoietic stem cells that is intended for use in quality control or as a diagnostic product:
ii: any substance containing a fraction of blood, a human organ, human bone marrow, human tissue, or human haematopoietic stem cells that the Governor-General by Order in Council ( see sections 57 to 65 controlled human substance
a: means—
i: human bone marrow (other than human bone marrow referred to in paragraph (a)(ii) of the definition of blood in this section) that may be used therapeutically or in the preparation of a substance for therapeutic use; or
ii: a constituent of human bone marrow described in subparagraph (i); or
iii: any other substance of the human body that may be used therapeutically or in the preparation of a substance for therapeutic use and that the Governor-General by Order in Council ( see
b: does not include—
i: a product derived from any controlled human substance that is intended for use in quality control or as a diagnostic product; or
ii: a substance containing a fraction of any controlled human substance that the Governor-General by Order in Council ( see sections 57 to 65
2: An order under this section is secondary legislation ( see Part 3 1956 No 65 s 92A The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 55(1) blood amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 55(1) controlled human substance amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 55(1) controlled human substance amended 28 October 2021 Secondary Legislation Act 2021 Section 55(2) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
56: Trading in human tissue generally prohibited
1: No person may, except under an exemption under section 60
2: A person commits an offence, and is liable on
a: the person intentionally or knowingly does an act; and
b: that act contravenes subsection (1).
3: Subsection (1) does not apply to the following:
a: a product derived from human tissue and intended for use in research, in quality control, or as a diagnostic product:
b: processed human tissue samples (for example, tissue arrays) intended for use in research, in quality control, or as a diagnostic product:
c: human hair collected from living people and that is, is part of, or is for use in, wigs or other hair-pieces:
d: human tissue that is, or is part of, a controlled drug or a medicine (other than a medicine that is a blood clotting factor, blood corpuscles, or whole blood).
4: Consideration for human tissue
5: Consideration referred to in subsection (4) may be required or accepted, or offered or provided, from or by 1 or more persons, or on 1 or more occasions, or both.
6: Use
7: This section does not limit or affect section 59 1956 No 65 s 92B Section 56(2) amended 1 July 2013 section 413 Criminal Procedure Act 2011
57: Collection of blood or controlled human substance
1: No person may collect blood or any controlled human substance from a person, or from the body of a person, for the purpose of obtaining that blood or that substance for administration to another person.
2: A person commits an offence, and is liable on
a: the person intentionally or knowingly does an act; and
b: that act contravenes subsection (1).
3: Subsection (1) does not apply to—
a: an appointed entity that is authorised to collect blood and controlled human substances from persons or bodies or both; or
b: an employee or agent of an appointed entity who is authorised by the entity to collect blood or controlled human substances on behalf of the entity, if the entity has the power to authorise employees or agents to do so.
4: For the purposes of subsection (3), an appointed entity is authorised to collect blood and controlled human substances, and has the power to authorise employees and agents of the entity to do so, unless the notice by which the entity is appointed provides otherwise.
5: Every appointed entity described in subsection (3)(a) and every employee or agent described in subsection (3)(b) who collects blood or any controlled human substance must give due recognition to the fact that the blood or controlled human substance has been donated. 1956 No 65 s 92C Section 57(2) amended 1 July 2013 section 413 Criminal Procedure Act 2011
58: Consideration not generally to be provided for collection of blood or controlled human substance for administration to another person
1: No person may, except under an exemption under section 60
2: A person commits an offence, and is liable on
a: the person intentionally or knowingly does an act; and
b: that act contravenes subsection (1).
3: Subsection (1) does not prevent a person who collects blood or a controlled human substance from providing to, or for the benefit of, the person from whom the blood or controlled human substance is collected consideration that is reasonably related to, or that does not exceed, the actual and reasonable costs incurred by that person in connection with its collection. 1956 No 65 s 92B(2) Section 58(2) amended 1 July 2013 section 413 Criminal Procedure Act 2011
59: Person administering blood or controlled human substance not to charge recipient for its collection or use
1: No person who administers blood or any controlled human substance to another person may, except under an exemption under section 60
2: A person commits an offence, and is liable on
a: the person intentionally or knowingly does an act; and
b: that act contravenes subsection (1).
3: This section does not limit or affect section 56 1956 No 65 s 92D Section 59(2) amended 1 July 2013 section 413 Criminal Procedure Act 2011
60: Exemptions
1: The Minister may, in his or her discretion, on any terms and conditions he or she thinks fit, and by notice in writing, exempt a person or persons or a class of persons from compliance with any or all of the provisions of—
a: section 56
b: section 58
c: section 59
d: section 61
2: The Minister may in the same manner vary or revoke an exemption under subsection (1).
3: A notice made under this section is secondary legislation ( see Part 3
4: After giving a notice under this section that is not secondary legislation, the Minister must—
a: publish a copy in the Gazette
b: present a copy to the House of Representatives no later than the 16th sitting day after the day on which the notice is given. 1956 No 65 s 92E The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication The maker must publish it in the Gazette LA19 ss 73 74(1)(a) cl 14 Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 60(3) replaced 28 October 2021 regulation 77 Legislation Act (Amendments to Legislation) Regulations 2021 Section 60(3)(a) amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 60(4) replaced 28 October 2021 regulation 77 Legislation Act (Amendments to Legislation) Regulations 2021 Section 60(4) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
61: Advertising prohibited
1: No person may, except under an exemption under section 60
2: A person commits an offence, and is liable on
a: the person intentionally or knowingly does an act; and
b: that act contravenes subsection (1).
3: Subsection (1) does not apply to distribution of an advertisement relating to the purchase or sale in New Zealand of the following:
a: a product derived from human tissue and intended for use in research, in quality control, or as a diagnostic product:
b: processed human tissue samples (for example, tissue arrays) intended for use in research, in quality control, or as a diagnostic product:
c: human hair collected from living people and that is, is part of, or is for use in, wigs or other hair-pieces:
d: human tissue that is, or is part of, a controlled drug or a medicine (other than a medicine that is a blood clotting factor, blood corpuscles, or whole blood).
4: Distribute
a: to publish or otherwise disseminate, by newspaper, magazine, periodical, book, billboard, radio, television, cinematograph film, or any other means (for example, by the Internet); or
b: to exhibit to public view in any premises or place; or
c: to deposit in any area, yard, garden, or enclosure comprising part of or appurtenant to any premises. 1956 No 65 s 92F Section 61(2) amended 1 July 2013 section 413 Criminal Procedure Act 2011
62: Liability of employers, principals, and directors
1: This section applies to an offence against section 56(2) 57(2) 58(2) 59(2) 61(2)
2: An act done by a person as the employee (the employee employer
a: the employer approved of the act; or
b: the employer knew that the act was to be done or was being done and failed to take all reasonable steps to prevent it.
3: An act done by a person as the agent (the agent principal
a: the principal approved of the act; or
b: the principal knew that the act was to be done or was being done and failed to take all reasonable steps to prevent it.
4: If a body corporate is convicted of an offence to which this section applies, a director of the body corporate is to be treated as having committed the same offence, if—
a: the director approved of the act that constituted the offence; or
b: the director knew the offence was to be or was being committed and failed to take all reasonable steps to prevent it.
5: Director 1956 No 65 s 92G
63: Appointed entities to collect and distribute blood and controlled human substances
1: The Minister may from time to time, by notice in writing, appoint 1 or more entities to be responsible for the performance of any functions in relation to blood and controlled human substances specified in the notice.
2: An appointment under subsection (1) may be subject to terms and conditions specified in the notice appointing the appointee.
3: The Minister may from time to time, by notice in writing, revoke, vary, or add to any of the following:
a: the functions for which an appointee is responsible:
b: the terms or conditions of the appointment.
4: The Minister may, at any time, by notice in writing, revoke an appointment under subsection (1).
5: A notice given under this section takes effect on the date specified for the purpose in the notice, or, if no date is so specified, on the day after the date on which it is issued.
6: An appointed entity that performs, in accordance with a notice given under this section, a function in relation to blood or a controlled human substance, is entitled to do anything, or refrain from doing anything, that is necessary or desirable for the purpose of performing that function, unless a notice given under this section provides otherwise.
7: After giving a notice under subsection (1), (3), or (4), the Minister must, as soon as practicable, publish in the Gazette 1956 No 65 s 92H
64: Exemption from Part 2 of Commerce Act 1986
1: Nothing in Part 2
a: a contract, arrangement, understanding, or covenant in relation to blood or controlled human substances that—
i: at the time it is entered into is, or is of a class that is, approved for the purposes of this section by the Governor-General by Order in Council; or
ii: is entered into by a person who (at the time it is entered into) is, or is of a class that is, approved for the purposes of this section by the Governor-General by Order in Council; or
b: an act done to give effect to a provision of a contract, arrangement, understanding, or covenant to which paragraph (a) applies.
2: An order under this section is secondary legislation ( see Part 3 1956 No 65 s 92I The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)(c) Presentation The Minister must present it to the House of Representatives, unless it relates exclusively to an individual (in which case a transitional exemption applies under Schedule 1 LA19 s 114 cl 32(1)(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 64(2) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
65: Protection of appointed entities
1: Section 129 section 63
2: For the purpose of applying section 129 section 63 Health Act 1956 1956 No 65 s 92J Exportation and importation of human tissue
66: Standards, etc, for export and import of human tissue
1: A person exporting or importing human tissue must comply with all relevant requirements and quality, safety, and other standards prescribed or approved by regulations under section 75
2: This section applies even if the exportation or importation of the tissue is required, permitted, or otherwise controlled by law.
3: A person commits an offence, and is liable on
a: the person intentionally or knowingly does, or omits to do, an act; and
b: that act or omission contravenes subsection (1). 2004 No 92 s 9(2)(a) Section 66(3) amended 1 July 2013 section 413 Criminal Procedure Act 2011
3: Technical and miscellaneous provisions
Enforcement provisions
67: Matters to be ascertained by authorised persons
An authorised person who believes on reasonable grounds that there is a place (the place section 68
a: collection or use of human tissue at the place involves a contravention of a section of this Act; or
b: there is located at the place any thing that is or may be evidence of a contravention of that kind. 2004 No 92 s 67
68: Powers of authorised persons
1: The powers referred to in section 67
a: enter the place:
b: inspect—
i: any equipment or device believed on reasonable grounds to be used in the place in relation to collection or use of human tissue:
ii: any document or record (whether in electronic or other form) in the place and that is believed on reasonable grounds to relate to any collection or use of human tissue:
c:
d: search for and seize—
i: any equipment or device referred to in paragraph (b)(i):
ii: any human tissue:
iii: any document or record (whether in electronic or other form) in the place and that is believed on reasonable grounds to relate to any collection or use of human tissue:
e: use any force for gaining entry to the place and for breaking open any article or thing that is in the place, being force that is reasonable in the circumstances and applied in a manner that is calculated to avoid adverse effects on any human tissue.
f:
g:
h:
2: The provisions of Part 4 subpart 3 sections 118 119
3: 2004 No 92 s 68 Section 68(1)(c) repealed 1 October 2012 section 258(2) Search and Surveillance Act 2012 Section 68(1)(f) repealed 1 October 2012 section 258(2) Search and Surveillance Act 2012 Section 68(1)(g) repealed 1 October 2012 section 258(2) Search and Surveillance Act 2012 Section 68(1)(h) repealed 1 October 2012 section 258(2) Search and Surveillance Act 2012 Section 68(2) replaced 1 October 2012 section 258(3) Search and Surveillance Act 2012 Section 68(3) repealed 1 October 2012 section 258(3) Search and Surveillance Act 2012
69: Entry of dwellinghouses and marae
1: An authorised person must not enter a dwellinghouse or marae under section 68(1)(a)
a: with the consent of an occupier of the dwellinghouse or marae; or
b: with the authority of a search warrant issued under subsection (2).
2: An issuing officer (within the meaning of section 3 subpart 3
a: an offence against this Act has been or is being committed; or
b: there is any thing that is or may be evidence of the commission of an offence against this Act.
3:
4: The search warrant authorises the authorised person to whom it is directed to exercise in respect of the dwellinghouse or marae all or any of the powers described in section 68
5: Subject to subsection (6) and section 72, the provisions of Part 4 sections 118 119
6: The authorised person to whom the search warrant is directed may execute it on 1 occasion on, or within 14 days after, the date of its issue. 2004 No 92 s 69 Section 69(2) amended 1 October 2012 section 258(4) Search and Surveillance Act 2012 Section 69(3) repealed 1 October 2012 section 258(5) Search and Surveillance Act 2012 Section 69(5) replaced 1 October 2012 section 258(6) Search and Surveillance Act 2012
70: Identification of authorised person
Section 70 repealed 1 October 2012 section 258(7) Search and Surveillance Act 2012
71: Notice requirements when place entered
Section 71 repealed 1 October 2012 section 258(7) Search and Surveillance Act 2012
72: Disposal of property seized
Subpart 6 section 68(1)(d)
a:
b:
c:
d: if any person is convicted of an offence to which the item relates, the Court may, if it thinks fit, order that the item be forfeited to the Crown or disposed of as the Court directs at the expense of the convicted person, and may order that the person pay any reasonable costs incurred by the authorised person or the Commissioner of Police in retaining the item. 2004 No 92 s 72 Section 72 amended 1 October 2012 section 258(8)(a) Search and Surveillance Act 2012 Section 72(a) repealed 1 October 2012 section 258(8)(b) Search and Surveillance Act 2012 Section 72(b) repealed 1 October 2012 section 258(8)(b) Search and Surveillance Act 2012 Section 72(c) repealed 1 October 2012 section 258(8)(b) Search and Surveillance Act 2012
73: Obstructing inspections, etc, by authorised persons
Every person commits an offence, and is liable on
a: obstructs, hinders, or resists an authorised person, or any person lawfully assisting an authorised person, in the exercise of the authorised person’s powers under this Act:
b: refuses or fails to comply with any lawful requirements of an authorised person under this Act. 2004 No 90 s 79 s 75 Section 73 amended 1 July 2013 section 413 Criminal Procedure Act 2011 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
1: The Governor-General may, by Order in Council, make regulations prescribing or approving standards for collection or use of human tissue for education, research, or other non-therapeutic purposes.
2: The standards may be to ensure minimum levels of quality, safety, or both, or may be for other purposes.
3: The standards must include requirements for ethical approval of all research using human tissue.
4: The requirements for ethical approval must not be inconsistent with requirements under the Human Assisted Reproductive Technology Act 2004
5: However, the standards or the regulations may identify research, or classes or kinds of research, using human tissue to which some or all of the requirements for ethical approval do not apply, or apply subject to conditions or modifications.
6: Regulations under this section are secondary legislation ( see Part 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 74(6) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
75: Regulations prescribing or approving requirements and quality, safety, and other standards for export and import of human tissue
1: The Governor-General may, by Order in Council, make regulations for either or both of the following purposes:
a: prescribing requirements for exportation of human tissue, importation of human tissue, or both:
b: prescribing or approving standards for exportation of human tissue, importation of human tissue, or both.
2: Requirements prescribed for importation of human tissue may relate to informed consent having been given and, if so, they may differ from similar requirements in this Act.
3: The standards may be to ensure minimum levels of quality, safety, or both, or may be for other purposes.
4: Subsections (2) and (3) do not limit subsection (1).
5: Regulations under this section are secondary legislation ( see Part 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 75(5) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
76: Regulations may incorporate standards by reference
Regulations under section 74 75 Schedule 5
77: Orders authorising establishment of schools of anatomy
1: The Governor-General may, by Order in Council, authorise the establishment of a school of anatomy where the study and practice of the science of anatomy may be carried on—
a: in connection with a university, or a school of medicine, specified in the order; and
b: at the place or places, and on the conditions (if any), specified in the order.
2: An order under this section is secondary legislation ( see Part 3 1964 No 19 s 7(1) The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 77(2) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
78: Regulations establishing or recognising national organ and tissue donor register
1: The Governor-General may, by Order in Council, make regulations establishing or recognising a register, maintained in any medium by or on behalf of the Crown and called the national organ and tissue donor register, for recording information that is or includes the following:
a: informed consent, informed objections, or nominations given, raised, or made for the purposes of this Act; and
b: amendments to, or revocations of, informed consent, informed objections, or nominations given, raised, or made for those purposes; and
c: other donor information.
2: The regulations may require the register to be maintained by or on behalf of the Crown in 1 or more specified media (whether or not it is maintained in other media).
3: The regulations may also require the register to be capable of, and to be maintained for, recording 1 or more specified classes, descriptions, or kinds of other donor information.
4: The regulations do not affect the application of the Privacy Act 2020
5: In particular, the regulations cannot authorise or require the recording in the register of personal information—
a: without authorisation or consent from the individual concerned; and
b: until he or she cancels, or otherwise opts out of, the recording in the register of that information.
6: Subsection (5) does not limit subsection (4).
7: Regulations under this section are secondary legislation ( see Part 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 78(4) amended 1 December 2020 section 217 Privacy Act 2020 Section 78(7) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
79: Regulations prescribing form of search warrant
Schedule 4 is repealed on the commencement of the first regulations made under this section. Human Tissue Act 2008 See s 79(2) above Section 79 repealed 1 October 2012 section 258(9) Search and Surveillance Act 2012 Inspectors of schools of anatomy
80: Appointment
1: The Director-General may from time to time appoint 1 or more persons as an inspector or inspectors of a school of anatomy.
2: The persons must be either—
a: members of the police appointed with the concurrence of the Commissioner of Police; or
b: persons who are not members of the police but are persons who wish to be appointed, and who the Director-General considers are suitable for appointment, as inspectors of the school of anatomy. 1964 No 19 s 8(1)
81: Term of office
An inspector continues in office until some other person is appointed in his or her place, unless the inspector ceases to hold that office earlier because he or she—
a: resigns from it with the consent of the Director-General; or
b: was appointed to it under section 80(1) and (2)(a)
c: dies; or
d: is removed from it under section 82 1964 No 19 s 8(2)
82: Removal of inspectors who are not members of police
1: If satisfied that 1 or more of the grounds for removal exist in relation to the inspector, the Director-General may at any time, by notice to the inspector, remove from office an inspector appointed under section 80(1) and (2)(b)
2: The grounds for removal are incapacity affecting performance of duty, neglect of duty, and misconduct.
3: Before removing an inspector from office, the Director-General must give the inspector a reasonable opportunity to make submissions, or be heard, or both, on the proposed removal.
4: The removal takes effect at the later of the following times:
a: when the removal notice is received by the inspector:
b: a later time specified for the purpose in that notice. 1993 No 82 s 20G(d)
83: Directions to inspectors
1: The Director-General may give inspectors written directions relating to how they must perform the duties of their office.
2: The inspectors must comply with those directions.
3: The Director-General may, by written notice given to the inspectors concerned, amend, revoke, or revoke and replace a written direction under this section. 1964 No 19 s 8(1)
84: Inspectors must report irregularities
1: An inspector of a school of anatomy must, as soon as is reasonably practicable, report in writing to the Director-General every irregularity (if any) that appears to that inspector to have occurred in respect of the receipt, possession, storage, or other use of a body removed—
a: to the school for anatomical examination; or
b: from the school to another place, under section 53
2: The report must give details of every irregularity concerned and, as far as they are known to the inspector, identifying details of the individual whose body was concerned.
3: Inspectors of the same school of anatomy may combine their reports, or report together jointly, under this section. 1964 No 19 s 8(3)
85: Inspectors may visit and inspect school
An inspector may, at any reasonable time, visit and inspect the school of anatomy for which he or she is appointed as an inspector. 1964 No 19 s 8(4) 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
1: A health agency that holds health information about an individual who has died need not obtain from the individual’s representative authorisation for disclosure of the information if—
a: the agency believes on reasonable grounds that it is not desirable or not practicable to obtain authorisation of that kind; and
b: the disclosure is by a person authorised by the agency to a person authorised by an authorised tissue bank; and
c: the disclosure of the information is for the purposes of helping the authorised tissue bank, or its agents or employees, to ascertain—
i: whether tissue of the individual, collected before death or from his or her body, is or may be suitable for use for transplantation or other therapeutic purposes; and
ii: whether any consent required by law for use for those purposes of tissue of that kind has been, or may be, given.
2: The health information about the individual may include—
a: the fact that the individual has died; and
b: identifying details of the individual; and
c: identifying details and contact details of members of the individual’s family.
3: Authorised tissue bank Gazette health agency health information representative clause 3 section 46 Repeal of organ donor provisions in driver licensing legislation
87: Land Transport Act 1998 amended
1: This section amends the Land Transport Act 1998
2: Section 28(1)(i)
3: The following section is inserted after section 28A
28B: Transitional provision for driver licences showing organ donor information about holders, etc
1: Organ donor information (if applicable) about the holder continues to be shown on a driver licence, despite the repeals and revocations effected by sections 87 and 88 of the Human Tissue Act 2008
2: This section does not limit or affect section 199(9) to (11)
4: Section 199(2)(q)
5: Section 199(5) any of subsections (4) to (6) subsection (4) or (6)
6: Section 199 inserting the following subsections after subsection (8)
9: The national register may, but need not, continue to show organ donor information, despite the repeals and revocations effected by sections 87 and 88 of the Human Tissue Act 2008 section 28B
10: The Authority may retain for initial disclosure, and may disclose (initially, and again on 1 or more later occasions during the period specified in this subsection), and may for 5 years (or a shorter period considered appropriate by the Authority) after initial disclosure under this subsection retain to disclose again under this subsection, to the national organ and tissue donor register (as defined in section 6 of the Human Tissue Act 2008
a: on the relevant driver licence, under section 28B
b: by the national register, under subsection (9).
11: Subsection (10) overrides subsection (9). OIC Land Transport Act 1998 Section 89 of this Act is the commencement prov for this section. Section 87(6) amended 10 May 2011 section 100(3) Land Transport (Road Safety and Other Matters) Amendment Act 2011
88: Land Transport (Driver Licensing) Rule 1999 amended
1: This section amends the Land Transport (Driver Licensing) Rule 1999
2: Rules 9(h) 63(1)(k) OIC Land Transport (Driver Licensing) Rule 1999 Section 89 of this Act is the commencement prov for this section.
89: Commencement of sections 87 and 88
1: Subsections (1) and (5) of section 87
2: Sections 87(2) to (4) and (6) 88
3: The date appointed under subsection (2) must be the same as, or after, the date appointed under subsection (1).
4: A date appointed under subsection (1) or (2) must be the same as, or after, the date appointed under section 2(3)
5: Dates appointed under section 2(3)
6: An order under this section is secondary legislation ( see Part 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 89(6) inserted 28 October 2021 section 3 Secondary Legislation Act 2021 Amendment ensuring taking of tissue from live donor for transplantation, etc, is health treatment
90: Interpretation
1: This section amends the Health and Disability Commissioner Act 1994
2: Section 2(1) health treatment A
a: transplantation, or another therapeutic purpose, for the benefit of 1 or more persons other than A:
b: educational purposes or research purposes OIC SR 2008/311 2008-11-01 Health and Disability Commissioner Act 1994 Amendment to Human Assisted Reproductive Technology Act 2004 and relating to gametes and embryos
91: Regulations
1: This section amends the Human Assisted Reproductive Technology Act 2004
2: Section 76
1A: Regulations under subsection (1)(a)(i) may prescribe requirements (not inconsistent with this Act, the Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996, or the Human Tissue Act 2008) for informed consent for collection of gametes, embryos, or both—
a: from dead individuals; and
b: in connection with, or for the purposes of, the performance of assisted reproductive procedures, the conduct of human reproductive research, or any other lawful use or uses of the gametes, embryos, or both.
1B: Subsection (1A) does not limit subsection (1)(a)(i) or the power under section 6 to declare procedures or treatments not to be established procedures if they involve the use of gametes or embryos collected from a person, who has since died, who did not consent to the specific use of the gametes or embryos before that person’s death. OIC SR 2008/311 2008-11-01 Human Assisted Reproductive Technology Act 2004 Consequential amendments and repeals
92: Consequential amendments
The Acts listed in Schedule 6 OIC SR 2008/311 2008-11-01 Births, Deaths, and Marriages Registration Act 1995 OIC SR 2008/311 2008-11-01 Coroners Act 2006 OIC SR 2008/311 2008-11-01 Corrections Act 2004 OIC SR 2008/311 2008-11-01 Electronic Transactions Act 2002 OIC SR 2008/311 2008-11-01 Health Act 1956 OIC SR 2008/311 2008-11-01 Health and Disability Services (Safety) Act 2001 OIC SR 2008/311 2008-11-01 Health Practitioners Competence Assurance Act 2003 OIC SR 2008/311 2008-11-01 Health Sector (Transfers) Act 1993 OIC SR 2008/311 2008-11-01 Human Rights Amendment Act 2001 OIC SR 2008/311 2008-11-01 New Zealand Public Health and Disability Act 2000 OIC SR 2008/311 2008-11-01 Relationships (Statutory References) Act 2005
93: Repeals
1: The Human Tissue Act 1964
2: Part 3A OIC SR 2008/311 2008-11-01 Human Tissue Act OIC SR 2008/311 2008-11-01 Health Act 1956 Savings and transitional provisions
94: Exemptions under section 92E(1) of Health Act 1956
1: This section applies to notices given under section 92E(1) Part 3A
2: On and after that repeal, those notices must be treated as if they were given under section 60
95: Entities appointed under Health Act 1956 to collect and distribute blood and controlled human substances
1: This section applies to appointments under section 92H Part 3A
2: On and after that repeal, those appointments must be treated as if they were made under section 63
96: Schools of anatomy and inspectors of them
1: Orders authorising the establishment of schools of anatomy and in force on the repeal of the Human Tissue Act 1964 section 77
2: Orders authorising the establishment of schools of anatomy section 3 section 7
a: Order in Council Authorising the Establishment of a School of Anatomy in connection with the University of Otago, 15 June 1876 New Zealand Gazette
b: Order in Council Authorising the Establishment of a School of Anatomy in connection with Auckland University College, 5 March 1888 New Zealand Gazette
c: University of Otago School of Anatomy Order 1969
d: University of Otago School of Anatomy Order 1988
3: Every inspector of a school of anatomy who was in office immediately before the repeal of the Human Tissue Act 1964
a: under section 80(1) and (2)(a)
b: under section 80(1) and (2)(b)
4: Every direction by the Minister to an inspector of a school of anatomy under section 8(1) section 83
97: Existing holdings of human tissue
1: This section applies to human tissue that, immediately before the repeal of the Human Tissue Act 1964 existing holdings
2: Collection, use, exportation, and importation of existing holdings must comply with all relevant requirements and quality, safety, and other standards prescribed or approved by regulations under section 74 75
3: However, no other requirements in this Act apply to existing holdings, and the Human Tissue Act 1964
4: To avoid doubt requirements


1: Title
This Act is the Electricity (Disconnection and Low Fixed Charges) Amendment Act 2008.
2: Commencement
This Act comes into force on the day after the date on which it receives the Royal assent.
3: Principal Act amended
This Act amends the Electricity Act 1992 2008-04-19 Electricity Act 1992
4: Low fixed charge tariff option for domestic consumers
1: Section 172B(2) low-use consumer low-use consumer
2: Section 172B(3)
ab: specifying which domestic consumers are low-use consumers (these types of consumer may, for example, vary according to the particular area of New Zealand in which the domestic premises are situated, or according to whether the domestic premises are the domestic consumer’s principal place of residence): .
3: Section 172B(3)
e: specifying criteria for the Minister to exempt electricity providers, or electricity providers in relation to particular areas, from the application of the regulations if, in the opinion of the Minister,—
i: the electricity providers materially comply with the objective of this section; or
ii: the electricity providers would incur a significant or unreasonable cost to comply with the regulations.
5: Electricity governance regulations
1: Section 172D(1)
22A: providing for the terms and conditions on which electricity retailers must provide domestic consumers with billing and payment options (for example, smoothed payments and redirection of income):
22B: providing for the terms and conditions on which electricity retailers must provide domestic consumers with information about overdue accounts and disconnection processes: .
2: Section 172D(1)
24A: providing for electricity retailers to proactively provide information about a particular domestic consumer or a particular domestic consumer’s account—
a: to the consumer; and
b: with the consumer’s authorisation, to Government agencies: .
3: Section 172D(1)
25A: providing for the terms and conditions on which electricity retailers may and may not disconnect prescribed classes of domestic consumers:
25B: providing for the terms and conditions on which electricity retailers must reconnect a domestic consumer’s electricity after a disconnection:
25C: providing for the terms and conditions for the supply of electricity or line function services to domestic consumers by electricity retailers or electricity distributors: .
4: Section 172D
3A: Subsection (1)(24A)