Public annotation — Why this follow-up OIA exists

This request follows a sequence of Official Information Act responses that have established an important but under-examined fact: no New Zealand public agency has clearly articulated responsibility for assuring informed consent across medicines regulation, ethics oversight, and health service delivery.

Earlier requests confirmed what information does not exist.

This follow-up request tests who, if anyone, is accountable.

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What has already been established on the public record

1. Medicines Act & consent (FYI #33349)

In response to FYI #33349 — Medicines Act interpretation, ethics oversight, and consent frameworks, the Ministry of Health / Medsafe and Health New Zealand confirmed that:
• The Medicines Act 1981 regulates medicines, but does not address informed consent.
• Medsafe holds no internal analysis or guidance explaining how medicines approval interacts with consent obligations.
• Ethics oversight relies on generic national standards, with no vaccine-specific consent framework.
• Health NZ relies on training and guidance only, with no national consent templates, audits, or assurance reviews.
• No agency has conducted a system-level evaluation of whether consent practices meet legal or ethical thresholds.

That request is now closed and marked on the public record as “information not held” in respect of core governance artefacts.

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2. A confirmed governance gap

Taken together, those responses establish that:
• Medicines regulation, ethics oversight, and clinical practice are institutionally siloed.
• No agency holds documents that bridge these domains.
• The absence of material is not accidental — agencies explicitly state such information is not held.

The unanswered question is therefore no longer “what documents exist?”, but:

Who is responsible for assuring informed consent, if anyone?

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Purpose of this follow-up request

This follow-up OIA is deliberately framed to avoid re-litigating document existence.

It instead asks agencies to identify:
• which agency (or agencies) is formally responsible for consent assurance;
• whether that responsibility is defined in law, Cabinet decisions, or operating models;
• whether any agency reviews consent adequacy at a system level;
• how risks arising from fragmented responsibility are identified or managed; and
• whether the absence of a single accountable body has ever been considered.

In short, this request tests accountability and ownership, not paperwork.

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Why this matters

For the public, this goes to a basic expectation:
that informed consent — a core legal and ethical requirement — is not left to chance or informal practice.

For journalists and investigators, the significance is structural:
• If no agency is accountable, that is a governance finding, not an administrative oversight.
• If accountability is distributed, the public is entitled to know how risks are managed.
• If no one is responsible, that itself is high-value public-interest information.

This request is designed so that any answer — including “no agency is responsible” — is meaningful.

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Related requests for context

Readers may wish to review the following related FYI requests, which together form a coherent public record:
• FYI #33349 — Medicines Act interpretation, ethics oversight, and consent frameworks
Established that no agency holds consent-governance artefacts.
• FYI #33398 — Veterans’ Advisory Board visibility of charities and signposting gaps
Demonstrates a similar pattern of acknowledged gaps without ownership.
• FYI #33682 — Decision-making on veteran navigation and non-statutory support
Tests accountability rather than document existence in a different policy domain.

These requests reflect a broader pattern: absence of ownership where responsibility spans multiple agencies.

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What to watch for in the response

When this request is answered, key signals will include:
• whether agencies identify a lead accountable body, or deny that one exists;
• whether accountability is described as “shared” without defined assurance mechanisms;
• whether responsibility is implicitly pushed back onto clinicians or providers; or
• whether the question is reframed as operational rather than governance-level.

Each of those outcomes has distinct implications.

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Status

This request is active.
No assumptions are made about the outcome.

This annotation is provided to assist readers in understanding why the question is being asked, and how it fits into the wider public record.