To: Te Whatu Ora – Office of the General Counsel / Legal Services
Via: FYI.org.nz

Official Information Act Request

I request the following information from Te Whatu Ora’s Legal Team (Office of the General Counsel) under the Official Information Act 1982.

This request concerns how Te Whatu Ora legally interprets consent requirements when hospitals use broad terminology such as “biologics,” “biogenic agents,” or “biological products” in consent forms or clinical procedures.

1. Legal Advice and Interpretation – Consent & Biologics

Please provide any Te Whatu Ora legal advice, internal legal interpretations, legal opinions, or legal risk assessments (internal or external) created since 1 January 2019 concerning:

1.1. Whether the classification of vaccines as “biologics,” “biological products,” or “biogenic agents” has any legal implications for consent requirements under:

NZ Bill of Rights Act 1990, s11

Code of Rights, particularly Rights 5–7

Medicines Act 1981

Health Practitioners Competence Assurance Act

Te Whatu Ora clinical governance standards

any other relevant legislation or case law.

1.2. Whether a general surgical consent form containing a clause such as “blood products, biologics, or agents deemed clinically necessary” could ever constitute legally sufficient consent for:

a routine vaccine,

an immunisation,

a prophylactic biologic injection,

a non-emergency biological agent.

1.3. Any legal position statements determining whether vaccines require explicit consent separate from broad “biologics” consent.

2. Hospital Use of Terminology – Legal Review

Please provide:

2.1. Any legal review or assessment of the terms used in hospital consent forms including:

“biologics”

“biological products”

“biogenic agents”

“pharmaceutical biologicals”

“biotechnology-derived agents”

2.2. Any documents analysing whether Te Whatu Ora consent language:

complies with NZ Bill of Rights Act section 11,

complies with Right 7 (informed consent) of the Code of Rights,

creates legal ambiguity regarding injectable treatments.

2.3. Any guidance to hospitals about avoiding ambiguity in consent wording.

3. Legal Risk Assessments – Injectables Administered Under Anaesthesia

Please provide any legal advice, risk assessments, incident reviews, or policy interpretations regarding:

3.1. The legal status of consent for injectable products administered while the patient is:

unconscious,

sedated, or

under general anaesthesia.

3.2. Whether vaccines, prophylactic biologics, or immunological agents may be administered under anaesthesia without additional express consent.

3.3. Any internal legal reviews of cases or complaints involving patients alleging:

consent was not obtained,

consent was too broad (“biologics”),

“bundled consent” was applied incorrectly.

4. Interaction Between Medsafe Classification & Consent Law

Please provide any internal legal analysis of:

4.1. How Medsafe’s classification of vaccines as biological medicines / biologics / biological products interacts with:

hospital consent requirements,

informed-consent law,

clinician obligations,

rights under the HDC Code.

4.2. Whether Te Whatu Ora has undertaken any legal review to assess if Medsafe’s regulatory terminology affects:

patient understanding,

wording in consent documents,

clinician legal responsibilities.

5. Guidance Issued to Clinical Staff

Please provide copies of:

5.1. Any legal memos, directives, or guidelines sent from Te Whatu Ora legal services to:

hospitals,

clinical directors,

authorised vaccinators,

surgical teams,

nursing leadership,

that discuss:

terminology such as “biologics/biologicals,”

consent requirements for injectables,

legal risk associated with broad consent wording,

any restrictions on administering vaccines without explicit consent.

6. OIA / Public Inquiry History

Please provide:

6.1. Copies of any prior legal-team-reviewed OIA responses (since 2018) that mention:

“biologic”

“biological product”

“vaccine classification”

“consent + biologics”

“biogenic agent”

“injectable consent under anaesthesia”.

6.2. Any internal legal briefings responding to public concerns about biologics terminology in NZ hospitals.

Format Request:

Please provide all information in electronic format.
Where information is withheld, please specify the exact section of the OIA relied upon and explain public-interest considerations.

Kind Regards,
Spencer Jones