133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
12 March 2026
Spencer Jones
By email: [FYI request #33686 email]
Ref:
H2026078575
Tēnā koe Spencer
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health – Manatū Hauora (the Ministry) on 10 February 2026. Each part of your request is
responded to in turn:
1.
Which agency (or agencies) is formally responsible for assuring that informed
consent requirements are met in the context of:
•
medicines approval and regulation;
•
vaccination and immunisation programmes; and
•
large-scale or population-level use of medicines.
In New Zealand, the Health and Disability Commissioner (HDC) — Te Toihau Hauora,
Hauātanga — is the primary agency responsible for promoting and protecting consumer rights,
including the right to informed consent. The HDC oversees compliance with the Code of Health
and Disability Services Consumers' Rights (1996), which established that informed consent is a
legal requirement. If informed consent is not obtained, complaints can be made directly to the
HDC.
While the HDC ensures the rights are upheld, the individual health provider (eg, doctor, nurse,
specialist) is responsible for obtaining informed consent before any treatment.
The Medical Council of New Zealand (MCNZ) sets standards for doctors regarding informed
consent. Other regulatory authorities and professional organisations as well as employers also
provide guidance on informed consent.
The Royal New Zealand College of General Practitioners provides guidance and standards and
accredits practices on meeting their informed consent standard here:
www.rnzcgp.org.nz/running-a-practice/the-foundation-standard/turoro-patients/12-informed-
consent-right-7/.
Health care providers regulated under the Health and Disability Services (Safety) Act 2001 are
checked for compliance with informed consent requirements through audits against the Ngā
Paerewa Health and Disability Services Standard.
In relation to the specific areas you requested information on:
•
medicines approval and regulation;
This does not include consideration of informed consent. Professional advice is available to
prescribers on ensuring written informed consent in some situations where a riskier medicine in
prescribed. For example, anti-seizure medicines.
•
vaccination and immunisation programmes;
Immunisation programmes are governed by Health NZ who provide education and information
to health practitioners and patients. There are situations where written informed consent is
required. For example, for vaccinations at school when the child’s care giver cannot be present
to give verbal consent.
•
large-scale or population-level use of medicines.
These situations would be assessed by public health professionals or the responsible
practitioner at a facility to ensure informed consent requirements were covered.
2.
Whether that responsibility is defined in legislation, Cabinet decisions, inter-agency
agreements, delegations, or operating models, and if so:
•
the instrument relied upon (e.g. Act, regulation, Cabinet paper, mandate,
or formal role description);
•
the agency or role designated as accountable.
The Ministry is not aware of any agency having formal responsibility beyond the responsibilities
described above.
3.
Whether any agency has responsibility for reviewing or assuring consent adequacy
at a system level, including
•
monitoring whether consent practices meet legal and ethical requirements;
•
identifying systemic risks or gaps in consent practice; or
•
initiating corrective action where consent is found to be inadequate.
The Ministry is not aware of any agency having formal responsibility beyond the responsibilities
described above.
4.
If no single agency holds this responsibility, please confirm:
•
whether accountability is considered distributed;
•
how risks arising from that fragmentation are identified or managed; and
•
whether the absence of a single accountable body has been formally
considered.
Accountability is considered distributed. As this is a primarily a responsibility of health
professionals, the responsible authorities have a significant role. Health providers usually have
clinical governance structures that would have oversight of policies and procedures relating to
consent. The HDC monitors the complaints it receives and passes this information onto
providers and other health agencies.
Page 2 of 3
5.
Whether any agency has considered establishing a formal consent-assurance or
consent-governance function, and if so:
•
when this was considered;
•
which agency led or participated in that consideration; and
•
the outcome (including reasons for proceeding or not proceeding).
The Ministry is not aware of any agency considering establishing such a function.
I trust this information fulfils your request. If you wish to discuss any aspect of your request with
us, including this decision, please feel free to contact the OIA Services Team on:
[email address].
Under section 28(3) of the Act, you have the right to ask the Ombudsman to review any
decisions made under this request. The Ombudsman may be contacted by email at:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Ministry website at:
www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests.
Nāku noa, nā
Dr Joe Bourne
Chief Medical Officer
Strategy and Policy | Te Pou Rautaki
Page 3 of 3
