Medicines Act interpretation, ethics oversight, and consent frameworks
SPENCER JONES made this Official Information request to Ministry of Health
The request was partially successful.
From: SPENCER JONES
Kia ora,
Pursuant to the Official Information Act 1982, I request the following information in the public interest. 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.
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.
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.
Part C – Te Whatu Ora consent frameworks
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.
Scope and assistance
This request seeks existing documents only. It does not seek the creation of new material. If any part of this request is considered too broad, I request assistance under section 13 of the Act to refine scope so that relevant information can be released.
Kind regards,
Spencer Jones
From: OIA Requests
Kia ora Spencer,
Thank you for your request under the Official Information Act 1982 (the
Act), received by the Ministry of Health on 21 December 2025. You
requested:
"Pursuant to the Official Information Act 1982, I request the following
information in the public interest. 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.
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.
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.
Part C – Te Whatu Ora consent frameworks
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.
Scope and assistance
This request seeks existing documents only. It does not seek the creation
of new material. If any part of this request is considered too broad, I
request assistance under section 13 of the Act to refine scope so that
relevant information can be released."
The reference number for your request is H2025077215. As required under
the Act, the Ministry will endeavour to respond to your request no later
than 20 working days after the day your request was
received: [1]http://www.ombudsman.parliament.nz/.
Please be advised that due dates for requests received on 27 November 2025
onwards will take into account the summer holiday period (25 December 2025
to 15 January 2026). Please refer to this guide for an explanation of
the [2]statutory obligations under the Official Information Act 1982.
If you have any queries related to this request, please do not hesitate to
get in touch ([3][email address]).
Ngā mihi
OIA Services Team
Ministry of Health | Manatū Hauora
M[4]inistry of Health information releases
------------------- Original Message -------------------
From: SPENCER JONES <[FOI #33349 email]>;
Received: Sun Dec 21 2025 16:50:54 GMT+1300 (New Zealand Daylight Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Medicines Act interpretation,
ethics oversight, and consent frameworks
Kia ora,
Pursuant to the Official Information Act 1982, I request the following
information in the public interest. 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.
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.
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.
Part C – Te Whatu Ora consent frameworks
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.
Scope and assistance
This request seeks existing documents only. It does not seek the creation
of new material. If any part of this request is considered too broad, I
request assistance under section 13 of the Act to refine scope so that
relevant information can be released.
Kind regards,
Spencer Jones
-------------------------------------------------------------------
This is an Official Information request made via the FYI website.
Please use this email address for all replies to this request:
[FOI #33349 email]
Is [Ministry of Health request email] the wrong address for Official Information requests
to Ministry of Health? If so, please contact us using this form:
[5]https://aus01.safelinks.protection.outlo...
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[6]https://aus01.safelinks.protection.outlo...
If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.
-------------------------------------------------------------------
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************
References
Visible links
1. http://www.ombudsman.parliament.nz/
2. https://aus01.safelinks.protection.outlo...
https://www.ombudsman.parliament.nz/reso...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
https://www.health.govt.nz/about-ministr...
5. https://fyi.org.nz/change_request/new?bo...
6. https://fyi.org.nz/help/officers
hide quoted sections
From: OIA Requests
Kia ora,
Thank you for your request for official information received on 21
December 2025 for:
“Pursuant to the Official Information Act 1982, I request the following
information in the public interest. 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 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.”
We are contacting you to clarify this part of your request. Please be
aware that HDECs only consider vaccine research, and provide no guidance
on vaccine programmes.
Please clarify if you are also asking about vaccine research.
Please note, under section 15 of the Official Information Act 1982, any
clarification or amendments made to a request within seven days after the
date it is received, that request may be treated as a new request and the
time limit for the response restarts.
We look forward to receiving your response.
Ngâ mihi
OIA Services Team
Ministry of Health | Manatû Hauora
M[1]inistry of Health information releases
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************
References
Visible links
1. https://www.health.govt.nz/about-ministr...
hide quoted sections
From: SPENCER JONES
Kia ora,
Thank you for your message.
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.
I understand HDECs do not provide oversight of public vaccination programmes; this is not sought under Part B.
Parts A and C of the request remain unchanged.
Kind regards,
Spencer Jones
From: OIA Requests
Tēnā koe,
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health-Manatū Hauora on 21 December 2025 for:
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.
These parts of your request ask for information which is more closely
connected with the functions of Heal New Zealand - Te Whatu Ora. For this
reason, the Ministry has decided to partially transfer your request to
Health New Zealand under section 14(b)(ii) of the Act. You can expect a
response from their agency in due course. Their contact email
is: [1][email address].
The Ministry will provide a response to the remainder of your request in
due course.
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: [2][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
Ministry of Health | Manatū Hauora
M[3]inistry of Health information releases
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************
References
Visible links
1. mailto:[email address]
2. mailto:[email address]
3. https://www.health.govt.nz/about-ministr...
hide quoted sections
From: hnzOIA
Kia ora Spencer,
Thank you for your request for information regarding vaccination
consent. Please find attached our response to your request.
If you have any questions, please get in touch at
[1][email address]
If you are not happy with this response, you have the right to make a
complaint to the Ombudsman. Information about how to do this is available
at [2]www.ombudsman.parliament.nz or by phoning 0800 802 602.
Ngā mihi,
Stephanie
Government Services (OIA)
[3][email address]
Health New Zealand | Te Whatu Ora
Statement of confidentiality: This email message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege. If you are not the intended recipient, do not read, use,
disseminate, distribute or copy this message or attachments. If you have
received this message in error, please notify the sender immediately and
delete this message
References
Visible links
1. mailto:[email address]
2. http://www.ombudsman.parliament.nz/
3. mailto:[email address]
From: OIA Requests
Kia ora,
Please find attached the response for your request for official
information.
Ngā mihi,
OIA Services Team
Ministry of Health | Manatū Hauora
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************
hide quoted sections
SPENCER JONES left an annotation ()
Closing annotation — What this OIA establishes (and why it matters)
This Official Information Act request sought to clarify how informed consent, ethics oversight, and legal accountability are actually governed in New Zealand in relation to medicines (including vaccines), particularly where multiple agencies share responsibility.
While the agencies have now formally closed the request, the outcome is substantively revealing rather than document-producing.
Status of this request
• The request has been procedurally completed by all agencies involved.
• Final responses were issued by:
• Ministry of Health / Medsafe (Ref H2025077215, dated 10 February 2026), and
• Health New Zealand – Te Whatu Ora (Ref HNZ00107053, dated 4 February 2026).
• The request can therefore be considered closed from an OIA process perspective, subject to the requester’s right to complain to the Ombudsman.
⸻
What information was (and was not) provided
1. Medicines Act interpretation & informed consent (Medsafe / Ministry of Health)
Medsafe confirms that:
• The Medicines Act 1981 regulates medicines, including vaccines;
• Informed consent is not addressed within the Medicines Act; and
• Medsafe does not hold any internal documents that interpret how medicines regulation interacts with informed-consent obligations.
In short, no internal legal analysis exists (or is acknowledged to exist) explaining how statutory medicines approval frameworks connect to patient consent requirements.
This is not a partial release — it is a confirmation of absence.
⸻
2. Ethics oversight and consent guidance (HDEC / Ministry of Health)
The Ministry advises that:
• Health and Disability Ethics Committees (HDECs) rely on generic National Ethical Standards applicable to all health research;
• There is no vaccine-specific ethics or consent guidance held by the Ministry;
• No internal correspondence, briefings, or reports were identified that analyse consent adequacy for vaccination programmes.
Again, the response does not withhold material — it confirms that no such material exists or is held.
⸻
3. Operational consent frameworks (Te Whatu Ora)
Health NZ states that:
• Consent practices for immunisation rely on training and guidance (e.g. IMAC training and the publicly available Immunisation Handbook);
• There are no national consent templates, minimum information standards, or policy documents held;
• No internal reviews, audits, or evaluations exist assessing whether consent practices meet legal or ethical thresholds.
Consent, in practice, is treated as an operational matter, not as a system subject to formal governance review.
⸻
What this OIA establishes on the public record
Taken together, these responses establish several critical facts:
1. No single agency holds responsibility for informed consent governance
Medicines regulation, ethics oversight, and clinical practice are institutionally siloed, with no agency holding end-to-end accountability.
2. There is no documented bridge between medicines law and consent obligations
Despite the centrality of consent in healthcare law, no interpretive guidance exists linking medicines approval, ethics standards, and patient consent.
3. Ethics oversight is generic, not risk-specific
Vaccines and mass immunisation programmes are not subject to distinct consent analysis beyond general ethical principles.
4. Consent practices are not formally evaluated
Training and handbooks exist, but there is no evidence of systematic review, assurance, or auditing of consent adequacy at a national level.
5. The absence itself is the finding
This OIA does not reveal hidden documents — it confirms that key governance artefacts do not exist.
⸻
Why this matters
For the public, this request clarifies that:
• Assertions about “robust consent frameworks” are not underpinned by documented governance structures.
• Legal, ethical, and operational responsibilities are fragmented, with no agency owning the whole system.
For journalists and investigators, this OIA provides:
• A clear evidential baseline showing what the state does not hold, which is often as important as what it does hold.
• A starting point for examining accountability gaps, rather than compliance failures.
For policymakers and oversight bodies, it raises a fundamental question:
If informed consent is a core legal and ethical requirement, who is responsible for ensuring it is coherently governed, reviewed, and assured across the system?
⸻
How this OIA should be understood
This request was not unsuccessful because it failed to locate documents.
It was successful in establishing that no coherent consent governance framework exists in documented form across the agencies responsible.
That finding now sits on the public record.
⸻
Next steps (for readers)
Anyone concerned about consent, ethics, or medicines regulation may reasonably:
• Seek Ombudsman review of search adequacy or public interest considerations;
• Examine related OIAs on health governance, ethics, and regulatory accountability;
• Ask follow-up questions about decision-making responsibility, rather than document existence.
This annotation is intended to assist those future inquiries.
⸻
Marked as: Partially successful — information not held
Things to do with this request
- Add an annotation (to help the requester or others)
- Download a zip file of all correspondence (note: this contains the same information already available above).
Offensive? Unsuitable?
Requests for personal information and vexatious requests are not considered valid requests for Official Information (read more).
If you believe this request is not suitable, you can report it for attention by the site administrators
Report this request
SPENCER JONES left an annotation ()
Public Annotation – Context and Purpose
This request forms part of a broader set of Official Information Act requests examining how informed consent and ethical oversight are governed within New Zealand’s public health system, particularly where decision-making spans multiple statutory and operational frameworks.
Across several requests to agencies including Ministry of Health, Te Whatu Ora – Health New Zealand, and Health and Disability Ethics Committees, a recurring issue has emerged:
ethical, legal, and operational responsibilities for consent are distributed across different bodies, depending on whether an activity is classified as research, regulatory approval, or programme delivery.
This particular request focuses on existing documents (not opinions) that explain how:
• the Medicines Act 1981 is interpreted in relation to vaccines;
• ethical oversight mechanisms are defined; and
• informed-consent requirements are communicated and governed in practice.
A key point of clarification raised by the Ministry is that Health and Disability Ethics Committees provide oversight only for research, not for public vaccination programmes. That distinction is acknowledged.
The public-interest purpose of this request is therefore not to challenge that boundary, but to understand—through existing records—how ethical and consent governance is documented and assured outside the research context, and how statutory, ethical, and consumer-rights frameworks interact at a system level.
Where documents exist, their release supports transparency.
Where documents do not exist, that outcome is also informative, as it clarifies how responsibilities are structured and where governance relies on convention rather than formal guidance.
This request should be read alongside other FYI requests concerning consent frameworks, Medicines Act interpretation, and governance accountability, as part of a wider effort to improve public understanding of how consent obligations are articulated and overseen in New Zealand’s health system.
Link to this