Kia ora,

Pursuant to the Official Information Act 1982, I request the following information in the public interest. This request follows confirmation from Medsafe that vaccines are not formally classified as “biologics” under New Zealand regulatory definitions, and therefore focuses on statutory interpretation and consent obligations, rather than terminology.

Part A – Medicines Act 1981: interpretation and consent
1. Any internal legal advice, guidance, briefing papers, or interpretive notes held by the Ministry of Health or Medsafe that address how the Medicines Act 1981:
• regulates vaccines as medicines; and
• interfaces with informed-consent obligations for vaccination.
2. Any documents explaining how sections of the Medicines Act (including approval, distribution, and use provisions) are intended to operate in conjunction with patient consent requirements.

Part B – Ethics oversight and HDEC guidance
3. Any guidance, policies, or interpretive documents issued by or relied upon by the Health and Disability Ethics Committees (HDECs) concerning:
• informed consent for vaccination;
• consent standards for biological or biotechnology-derived medicines; or
• ethical distinctions (if any) between vaccines and other medicines for consent purposes.
4. Any correspondence between the Ministry of Health, Medsafe, and HDECs since 2015 discussing consent, ethics approval, or participant information in relation to vaccination programmes.

Part C – Te Whatu Ora consent frameworks
5. Any national policies, templates, or guidance issued to DHBs or Te Whatu Ora concerning:
• vaccination consent forms;
• minimum information requirements for consent; and
• how vaccination consent aligns with the Code of Health and Disability Services Consumers’ Rights.
6. Any internal reviews or evaluations addressing whether existing vaccination consent practices meet statutory and ethical requirements.

Scope and assistance

This request seeks existing documents only. It does not seek the creation of new material. If any part of this request is considered too broad, I request assistance under section 13 of the Act to refine scope so that relevant information can be released.

Kind regards,
Spencer Jones