Hospital Use of the Terms “Biologics/Biogenic Agents” and Consent Requirements for Vaccines and Injectable Products
SPENCER JONES made this Official Information request to Ministry of Health
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From: SPENCER JONES
To: Te Whatu Ora – Health New Zealand
Via: FYI.org.nz
Official Information Act Request
I request the following information under the Official Information Act 1982.
1. Hospital Consent Forms — Terminology
Please provide copies of:
(a) all hospital surgical, admission, perioperative, procedural, or general medical consent forms currently in use that include the terms:
“biologics”
“biogenic agents”
“biological agents”
“biological products”
“biomedical agents”
(b) any previous versions of these forms since 2019 that contain such terms.
2. Internal Definitions
Please provide:
(a) any Te Whatu Ora or DHB internal definitions, glossaries, or classification documents describing what is included under terms such as “biologic,” “biological agent,” or “biogenic injection” in hospital policy contexts.
(b) any documents describing whether vaccines are included within these categories for hospital-consent purposes.
3. Consent Requirements and Guidance
Please provide:
(a) any policy, guideline, memo, training material, risk assessment, or internal legal advice used by Te Whatu Ora about the consent requirements for administering:
vaccines
biologics
biologic injectables
immunomodulatory injectables
perioperative prophylactic injections
(b) any policy regarding whether a general surgical consent form permits administering:
a routine vaccine (e.g., influenza, COVID-19, HPV)
a prophylactic biological agent
any non-emergency injectable product not explicitly discussed with the patient.
4. Consent Under Anaesthesia
Please provide:
(a) any policy on administering vaccines or biologics to patients while under sedation or general anaesthesia.
(b) any legal interpretations of Rights 6–7 of the Code of Health and Disability Services Consumers’ Rights as they apply to consent for biologics or vaccines during anaesthesia.
5. Policy Change History
Please provide:
(a) any internal discussion papers, consultation documents, risk reviews, legal reviews, or minutes since 2018 relating to changes in the language or structure of hospital consent forms involving the incorporation of “biologics” terminology.
(b) any rationale documents citing alignment with international regulatory terminology (e.g., FDA, EMA, WHO) or Medsafe classifications.
6. Complaints or Incidents
Please provide:
(a) the number of complaints or incident reports filed with Te Whatu Ora or DHBs since 2019 where patients alleged:
they received an injection without adequate consent;
they were not informed that a product was a “biologic”;
they were vaccinated without explicit consent;
they believed broad consent (“biologics”) was interpreted too widely.
(b) any internal reviews of such complaints.
7. OIA Searches
Please provide copies of any OIA responses issued since 2020 containing policies or definitions relating to “biologics,” “biogenic agents,” or classification of vaccines under hospital consent frameworks.
8. Regulatory Interpretation
Please provide Te Whatu Ora’s interpretation of how Medsafe’s classification of vaccines as “biological medicines” interacts with hospital consent requirements.
I request this information in accessible electronic format.
If any item is withheld, please state the legal reason and public interest considerations as required under the OIA.
Kind regards,
Spencer Jones
SPENCER JONES left an annotation ()
✔ PART 3 — PUBLIC EXPLAINER (for FYI readers)
Are “biologics” new?
No. Vaccines have been classified as biologics since 1902 after major contamination deaths led to the Biologics Control Act.
Do NZ hospitals use the term?
Yes — often in general consent for surgery:
“blood products, biologics, medications necessary…”
But definitions are not well-published.
Does “biologic” mean “vaccine”?
In regulatory science: yes.
But in hospital practice: unclear — this is exactly what the OIA seeks to clarify.
Can vaccines be given without explicit consent?
NZ law says no (NZBORA s11, Code of Rights).
But broad consent language creates ambiguity that the public deserves clarity on.
Why file an OIA?
Because transparency about consent terminology is foundational to trust in healthcare,
and no one has ever obtained these definitions publicly.
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).
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SPENCER JONES left an annotation ()
Annotation for readers following this request
This OIA investigates an important and under-examined issue:
how New Zealand hospitals use the terms “biologics,” “biogenic agents,” and “biological products” in consent forms — and whether these terms include vaccines.
Why this matters:
NZ hospitals regularly use broad terms such as “biologics, blood products, or medications as clinically necessary” in surgical or medical consent.
Vaccines are biologics (this has been true for over 120 years under global regulatory law).
But no NZ OIA has ever examined whether hospitals explicitly define the scope of these terms, or how they relate to consent requirements.
This OIA does not assume misconduct.
Instead, it asks basic transparency questions:
What do NZ hospitals mean when they use the term “biologic” in consent forms?
Are vaccines included or excluded?
Has consent language changed in recent years?
Can a general consent form ever authorise a vaccine?
What protections exist for unconscious or anaesthetised patients?
A deep search of NZ health documents showed:
No evidence of a policy allowing vaccines without consent.
No public record of “biogenics” being used in NZ hospital policy.
No internal definitions publicly available about what “biologics” includes.
No publicly released review of consent‐form language since Te Whatu Ora was created.
No OIA has ever asked these questions before.
The historical research shows that vaccines have always been legally classified as biologics since 1902 — in the U.S., Europe, WHO systems, and NZ’s Medsafe alignment.
This classification is normal and longstanding.
But the public visibility of this terminology — and how hospitals use it in consent — is extremely low.
For informed consent to be meaningful, patients must understand:
what categories mean,
what treatments are included,
and what is excluded unless explicitly discussed.
This OIA aims to clarify those definitions.
It will be useful to:
patients,
hospital advocates,
health-law researchers,
informed-consent analysts,
and anyone following transparency issues in NZ healthcare.
Updates will be added when Te Whatu Ora responds.
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