22 December 2025
Spencer Jones
[FYI request #32966 email]
Tēnā koe Spencer
Your request for official information, reference: HNZ00104357
Thank you for your email on 24 November 2025, asking Health New Zealand | Te Whatu Ora
(Health NZ) for the following under the Official Information Act 1982 (the OIA):
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.
Response
We have made reasonable efforts to collate the information requested and are releasing the forms
we have been able to gather. We note that most regions use substantial y similar forms with only
local branding variations.
On balance your request is refused under section 18(f) of the OIA, as further collation across all
districts would require substantial research and collation.
I have considered whether fixing a charge for the supply of the information or extending the
timeframe for response would enable Health NZ to respond. I do not consider that either option
would remove the impact that supplying the information would have on our other operations.
Please refer to
Appendix One, which outlines our decision regarding the release of documents
within the scope of your request that we were able to obtain. The documents able to be released
are attached as
Appendix Two, Appendix Three and Appendix Four. Please note that some
information has been withheld under section 9(2)(a) of the OIA, to protect the privacy of natural
persons.
How to get in touch
If you have any questions, you can contact us a
t [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
www.ombudsman.parliament.nz or
by phoning 0800 802 602.
Nāku iti noa, nā
Danielle Coe
Manager (OIA) Government Services
Health New Zealand | Te Whatu Ora
Appendix One
#
Date
Title
Decision on release
Appendix Two – Te Waipounamu
1
October 2018 Clinical Service Practice
Some information withheld under
Manual Policy Statement
section 9(2)(a) of the OIA.
2
October 2020 Clinical Service Practice
Some information withheld under
Manual Policy Statement
section 9(2)(a) of the OIA.
3
January 2021 Clinical Service Practice
Some information withheld under
Manual Policy Statement
section 9(2)(a) of the OIA.
4
January 2023 Clinical Service Practice
Some information withheld under
Manual
section 9(2)(a) of the OIA
5
12/07/2023
Amgevita and Rheumatology
Some information withheld under
Information - OPD (Southland) section 9(2)(a) of the OIA.
6
15/12/2023
Informed Consent (Nelson
Released in full.
Marlborough)
7
08/04/2025
Informed Consent – For
Released in full.
Procedures (Nelson
Marlborough)
8
17/05/2023
Informed Consent to Procedure Released in full.
(Nelson Marlborough)
9
28/10/2020
Consent for Blood
Released in full.
products/Infusions (Nelson
Marlborough)
10 07/09/2023
Elective Booking Form – Adult
Released in full.
(Nelson Marlborough)
11 30/03/2022
Treatment/Procedure(s)
Released in full.
Without Consent
12 July 2024
Consents to
Released in full.
Operation/Procedure/Treatment
13 December
Clinician’s Decision to Treat
Released in full.
2024
(Waitaha Canterbury)
14 8 August 2022 Informed Consent (Te Tai o
Released in full.
Poutini West Coast and
Waitaha Canterbury)
15 May 2025
Consent to
Released in full.
Treatment/Procedure (Waitaha
Canterbury)
16 09/05/2023
Immunisation Guidelines –
Released in full.
NICU/SCBU
(District)(Southern)
17 17/03/2025
Staff Influenza Vaccination
Released in full.
Consent Form (Southern)
18 09/10/2023
Providing Haematological Care Released in full.
for Patients Who Decline Blood
Transfusion Policy
(District)(Southern)
19 20/11/2024
Referral to Outreach
Released in full.
Immunisation Service
Vaccine Preventable Disease
Team (District)(Southern)
20 03/10/2025
Tdap Vaccination Consent
Released in full.
Form (District)(Southern)
21 27/06/2023
Hepatitis B Vaccination
Released in full.
Consent Form
(District)(Southern)
22 27/06/2023
MMR Vaccination Consent
Released in full.
Form (District)(Southern)
23 12/07/2023
Varicella Consent Form
Released in full.
(District)(Southern)
24 15/03/2023
Population Health Vaccination
Released in full.
Programme Policy
(District)(Southern)
25 14/04/2023
COVID-19 Vaccination
Released in full.
Programme Policy
(District)(Southern)
26 29/10/2021
Twinrix (Hepatitis A&B)
Released in full.
Vaccination Consent Form
(District)(Southern)
27 01/12/2022
Record of Vaccination Form
Released in full.
NICU (Otago)
28 28/03/2023
What you need to
Released in full.
know about the flu
vaccination info sheet
(Southern)
29 31/05/2023
Immunisation during pregnancy Released in full.
consent form (Southern)
Appendix Three - Northern
1
December
Informed Consent (Waitematā) Released in full.
2023
2
27/06/2022
Informed Consent (Counties
Released in full.
Manukau)
3
January 2024 Informed Consent (Te Tai
Released in full.
Tokerau)
4
18/12/2023
Informed Consent (Te Toka
Released in full.
Tumai)
Appendix Four – Te Manawa Taki
1
N/A
Consent to Biologics Treatment Released in full.
- Ustekinumab (Stelara) (Lakes
District)
2
N/A
Consent to Biologics Treatment Released in full.
- Adalimumab
(Amgevita/Humira) (Lakes
District)
3
N/A
Consent to Biologics Treatment Released in full.
- Infliximab
4
July 2024
Employee Vaccination Consent Released in full.
(Hauora a Toi Bay of Plenty)
5
January 2023 Hepatitis B Immunisation for
Released in full.
the newborn (Hauora a Toi Bay
of Plenty)
6
June 2023
Immunisation Programmes –
Released in full.
Community Based (Hauora a
Toi Bay of Plenty)
7
May 2023
Clinical Practice Manual –
Released in full.
Medication – Health
Professional Roles &
Responsibilities (Hauora a Toi
Bay of Plenty)
8
September
Policy - Informed Consent
Released in full.
2024
Policy and Related Information
(Taranaki)
9
N/A
Consent for use of all blood
Released in full.
components and blood
products (Waikato)
10 N/A
Request for anaesthesia care
Released in full.
(Waikato)
11 14/03/2019
Informed Consent Policy
Released in full.
(Waikato)
12 N/A
Surgical Bundle – Waikato and Released in full.
Thames hospitals
13 21/04/2022
Consent for use of blood
Released in full.
products (Tairāwhiti)
14 N/A
Endoscopy Consent Form
Released in full.
(Tairāwhiti)
15 N/A
Informed Consent for
Released in full.
Healthcare Procedures
(Tairāwhiti)
16 N/A
Anaesthesia Consent
Released in full.
(Tairāwhiti)
17 N/A
Processes for safe
Released in full.
immunisation (Tairāwhiti)
18 April 2024
Informed Consent (Tairāwhiti)
Released in full.
TeWhatuOra.govt.nz
Health NZ, PO Box 793,
Wellington 6140, New Zealand
