Human Tissue Act 2008

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Reprint as at 1 November 2008

Human Tissue Act 2008

Public Act2008 No 28
Date of assent18 April 2008
Commencementsee section 2
Note

Changes authorised by section 17C of the Acts and Regulations Publication Act 1989 have been made in this reprint.

A general outline of these changes is set out in the notes at the end of this reprint, together with other explanatory material about this reprint.

This Act is administered by the Ministry of Health.

Contents

1 Title

2 Commencement

Part 1
General 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 2
Human 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

Tissue that is, or is collected from, bodies

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

Non-health-care tissue

33 Who is entitled to give informed consent to collection or use for donor analysis

Tissue from living individuals

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 3
Technical 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 1
Use for general purposes of tissue that is or is from bodies

Schedule 2
Use for anatomical examination or public display of tissue that is or is from bodies

Schedule 3
Use for secondary purposes after donor’s death of tissue from living individual

Schedule 4
Form of search warrant

Schedule 5
Incorporation of standards in regulations by reference

Schedule 6
Consequential amendments

Reprint notes

The Parliament of New Zealand enacts as follows: