Part 4Enforcement and miscellaneous provisions
Miscellaneous provisions
76Regulations
The Governor-General may, by Order in Council, make regulations for all or any of the following purposes:
- providing for the circumstances and the manner in which, and the conditions subject to which, any kind of assisted reproductive procedure may be performed or any kind of human reproductive research may be conducted, including, without limitation:
- prescribing requirements for informed consent in relation to the performance of assisted reproductive procedures or the conduct of human reproductive research, not being requirements that are inconsistent with this Act or the Health and Disability Commissioner (Code of Health and Disability Services Consumers' Rights) Regulations 1996:
- providing for the use or destruction of in vitro gametes or in vitro embryos, in particular, without limitation, in cases where one party from whom such a gamete or embryo has been obtained or formed withdraws his or her consent to any course of action:
- prescribing requirements or conditions for, or imposing restrictions on, the import into, or the export from, New Zealand of in vitro gametes or in vitro embryos, including, without limitation, requirements for the giving of informed consent (not being requirements that are inconsistent with this Act or the Health and Disability Commissioner (Code of Health and Disability Services Consumers' Rights) Regulations 1996) by persons from whom gametes are obtained overseas:
- requiring any person approved under section 20 as the person responsible for an activity to keep records of information of a kind provided for by the regulations (not being identifying information) in relation to that activity, and requiring that person to disclose, in the manner provided for by the regulations, that information to the advisory committee or any duly authorised representative of that committee or the Director-General of Health:
- requiring persons who perform, or who arrange for the performance of, established procedures or any class of health practitioner (within the meaning of the Health Practitioners Competence Assurance Act 2003) to keep records of information of a kind provided for by the regulations (not being identifying information) in relation to established procedures, and requiring those persons and health practitioners to disclose, in the manner provided for by the regulations, that information to the advisory committee or to any duly authorised representative of that committee or to the Director-General of Health:
- prescribing requirements for informed consent in relation to the performance of assisted reproductive procedures or the conduct of human reproductive research, not being requirements that are inconsistent with this Act or the Health and Disability Commissioner (Code of Health and Disability Services Consumers' Rights) Regulations 1996:
- prescribing offences in respect of the contravention of, or non-compliance with, any regulations made under paragraph (a) and the amounts of fines that may be imposed in respect of those offences, which fines must not exceed $20,000:
- prescribing the fees to be paid in relation to the taking of any action under Part 3 by the Registrar-General:
- providing for any other matters that are contemplated by, or necessary for giving full effect to, this Act, and for its due administration.
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—
- from dead individuals; and
- 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.
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.
Regulations under subsection (1)(a) may be made only on the recommendation of the Minister after the Minister has consulted and received advice from the advisory committee and consulted any other person the Minister thinks fit to consult.
Regulations under this section are secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).
Notes
- Section 76(1A): inserted, on , by section 91(2) of the Human Tissue Act 2008 (2008 No 28).
- Section 76(1B): inserted, on , by section 91(2) of the Human Tissue Act 2008 (2008 No 28).
- Section 76(3): inserted, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).


