133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
10 February 2026
Spencer Jones
By email:
[FYI request #33349 email]
Ref:
H2025077215
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 21 December 2025 for:
“This request follows confirmation from Medsafe that vaccines are not formally classified as
“biologics” under New Zealand regulatory definitions, and therefore focuses on statutory
interpretation and consent obligations, rather than terminology. Part A – Medicines Act 1981: interpretation and consent 1. Any internal legal advice, guidance, briefing papers, or interpretive notes held by the
Ministry of Health or Medsafe that address how the Medicines Act 1981: • regulates vaccines as medicines; and • interfaces with informed-consent obligations for vaccination. 2. Any documents explaining how sections of the Medicines Act (including approval,
distribution, and use provisions) are intended to operate in conjunction with patient consent
requirements.
The Medicines Act 1981 defines medicines in a way that includes vaccines, and governs their
approval, distribution, and use, the Act is public. However, it does not set out informed-consent
obligations as it concerns regulation of medicines not healthcare professional practice. Medsafe’s
interpretation of the Act for regulated entities is provided in the Guidelines on the Regulation of
Therapeutic Products in New Zealan
d (www.medsafe.govt.nz/regulatory/current-guidelines.asp). Since there are no documents linking the Act to patient consent, this part of your request is
refused under section 18(g)(i) of the Act, as the information requested is not held by the Ministry
and there are no grounds for believing it is held by another agency subject to the Act.
For your reference:
• Medicines Act 1981:
www.legislation.govt.nz/act/public/1981/0118/latest/DLM55061.html.
• Medicines Regulations 1984:
www.legislation.govt.nz/regulation/public/1984/0143/latest/DLM96579.html. Please refer
to section 44A specifically.
Part B – Ethics oversight and HDEC guidance
3. Any guidance, policies, or interpretive documents issued by or relied upon by the
Health and Disability Ethics Committees (HDECs) concerning: • informed consent for vaccination; • consent standards for biological or biotechnology-derived medicines; or • ethical distinctions (if any) between vaccines and other medicines for consent
purposes.
On 9 January 2026, the Ministry contacted you to clarify this part of your request. On the same
day, you advised:
To clarify Part B: I am seeking any guidance, policies, or interpretive documents held by the
Ministry of Health that relate to informed-consent standards applied by Health and Disability
Ethics Committees in the context of vaccine research.
The ‘National Ethical Standards Health and Disability Research and Quality Improvement’
guidelines are publicly available her
e: neac.health.govt.nz/national-ethical-standards/. Please
refer to section 7 specifically, for information on informed consent.
These standards apply to all medical research in New Zealand and so encompass guidance on
informed consent in vaccine research. There is no separate guidance specifically for vaccine
research.
4. Any correspondence between the Ministry of Health, Medsafe, and HDECs since
2015 discussing consent, ethics approval, or participant information in relation to
vaccination programmes.
The Ministry of Health includes both Medsafe and the secretariat support for the Health and
Disability Ethics Committees (HDECs). The Ministry does not hold any information relating to this
part of your request. Therefore, this part of your request is refused under section 18(g)(i) of the
Act.
Part C – Te Whatu Ora consent framework 5. Any national policies, templates, or guidance issued to DHBs or Te Whatu Ora
concerning: • vaccination consent forms; • minimum information requirements for consent; and • how vaccination consent aligns with the Code of Health and Disability Services
Consumers’ Rights. 6. Any internal reviews or evaluations addressing whether existing vaccination consent
practices meet statutory and ethical requirements.”
On 15 January 2026, these parts of your request were transferred to Health New Zealand – Te
Whatu Ora. You can expect a response from their agency in due course, who can be contacted
here:
[email address]. 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.
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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
Chris James
Group Manager
Medsafe
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