New Zealand Acts

HUMAN TISSUE ACT 2008

- As at 5 April 2023
- Act 28 of 2008

TABLE OF PROVISIONS

   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

   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
   19.     Collection or use for which informed consent required
   20.     Informed consent not required for collection or use for specified purposes
   21.     Other laws, and lawfulness of use, etc, not affected

           SUBPART 2 - Offences relating to informed consent

   22.     Collection or use without informed consent
   23.     Donor analysis, etc, without informed consent
   24.     Use for secondary purpose after donors’ deaths without informed consent
   25.     Affirmative defence for informed consent offences
   26.     Person 16 years old or older assumed to be capable
   27.     Consent or objection assumed to be free and informed
   28.     Person assumed to have taken into account immediate family’s cultural and spiritual needs, values, and beliefs
   29.     When consent or objection on behalf of immediate family may be assumed to comply with section 40
   30.     Death does not affect consent, objection, or nomination

           SUBPART 3 - Who is entitled to give informed consent

   31.     Who is entitled to give informed consent to collection or use for general purposes
   32.     Who is entitled to give informed consent to collection or use for anatomical examination or public display
   33.     Who is entitled to give informed consent to collection or use for donor analysis
   34.     Who is entitled to give informed consent to use for secondary purpose after donor’s death
   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
   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

   47.     Standards for collection or use of human tissue for non-therapeutic purposes
   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
   50.     Collection only by qualified person after examination
   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
   54.     Duty of those performing post-mortems or anatomical examinations, or collecting tissue from bodies
   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
   66.     Standards, etc, for export and import of human tissue

   PART 3 - Technical and miscellaneous 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
   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
   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
   86.     Disclosure to ascertain medical suitability and whether consent required for use has been, or may be, given
   87.     Land Transport Act 1998 amended
   88.     Land Transport (Driver Licensing) Rule 1999 amended
   89.     Commencement of sections 87 and 88
   90.     Interpretation
   91.     Regulations
   92.     Consequential amendments
   93.     Repeals
   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
           SCHEDULE 2
           SCHEDULE 3
           SCHEDULE 4
           SCHEDULE 5
           SCHEDULE 6