Kia ora,

Pursuant to the Official Information Act 1982, I request the following information. This request is interpretive and governance-focused, and does not seek general restatement of consent law.

Part A – Terminology governance

Any national-level guidance, directives, circulars, or internal position statements held by Te Whatu Ora that address whether the terms:

“biologics”,

“biological medicines”, or

“biogenic agents”
are recognised, used, discouraged, or excluded in public-hospital clinical governance, policy, or consent documentation.

If no such documents exist, please explicitly confirm whether Te Whatu Ora has:

adopted a position that such terminology has no interpretive or operational role in hospital consent processes; or

left interpretation entirely to local or regional discretion.

Part B – Consent thresholds and escalation

Any documents describing criteria or thresholds (other than general treatment risk) that would trigger:

enhanced consent requirements,

additional disclosure obligations, or

ethics escalation
for injectable medicines or vaccines used in hospital settings.

Confirmation of whether biological mechanism, platform, or origin (as distinct from clinical risk) is ever a factor in determining consent approach in Te Whatu Ora hospitals.

Part C – Ethics interface

Any guidance or correspondence held by Te Whatu Ora relating to the interface between hospital consent processes and HDEC ethics guidance, specifically addressing when a treatment moves from standard care into enhanced ethical scrutiny.

Scope

This request seeks existing documents or formal positions only. It does not seek new analysis, legal advice, or hypothetical commentary. If any part of the request is considered too broad, I request assistance under section 13 to refine scope.

Kind regards,
Spencer Jones