Dear Crown Law Office,

Pursuant to the Official Information Act 1982, I request the following information:

1/ Legal advice and internal correspondence between Crown Law and the Ministry of Health, and the Department of the PM and cabinet (DPMC), and Medsafe, concerning the grant of provisional consent to Comirnaty (Pfizer/BioNTech Covid-19 vaccine) under s23 of the Medicines Act 1981, including:

2/ Any advice or opinion regarding the requirement in s23 (pre-amendment) that consent be limited to “the treatment of a limited number of patients.”

3/ Any assessment of whether the provisional consent for Comirnaty was intra vires or ultra vires s23. Any briefings to DPMC, Medsafe and Ministry of Health.

4/ Crown Law reports relating to the urgent passage of the Medicines Amendment Act 2021 (enacted 19 May 2021), including:

a/ The legal advice justifying the removal of the “limited number of patients” wording.

b/ Any advice about the need for retrospective validation of provisional consents already granted (including Comirnaty).

c/ Any advice on alternative options that were considered but not adopted.

d/ Communications with external regulators (e.g., Australia’s TGA or international regulators) regarding whether provisional consent in New Zealand was consistent with the scope of s23 at the time.

5/ Any risk assessments prepared between November 2020 and June 2021 regarding the legality, legal risk, or judicial review exposure of provisional consents under s23.

Yours faithfully,

John Armstrong

Dear OIA,

Re: Request for Reconsideration – OIA-2526057

Thank you for your response dated 20 November 2025 regarding my Official Information Act request concerning the grant of provisional consent to the Comirnaty vaccine under section 23 of the Medicines Act 1981.

After reviewing your decision, I respectfully request that Crown Law reconsider its position for the reasons outlined below.

1. The refusal is a blanket application of s9(2)(h), which is not permitted

Your response states that all 80 documents and all 915 emails identified in your search contain legally privileged information. A blanket refusal of all material is inconsistent with the OIA, which requires a document-by-document assessment and the release of:
* factual material
* administrative correspondence
* information not created for the purpose of legal advice
* attachments originating from other agencies
* information already in the public domain

Please confirm that each document was individually assessed, rather than withheld on a categorical basis.

2. Failure to consider section 16 – alternative ways of releasing information

You did not discuss whether the information could be provided in:
* redacted form,
* summary form, or
* extraction of factual, non-privileged elements.

Section 16 imposes a positive duty to consider such alternatives.

3. The public interest test under s9(1) was not adequately addressed.

Your decision asserts, without analysis, that the public interest does not outweigh withholding. Given:
* the national significance of the provisional consent process,
* the subsequent urgent legislative amendment (Medicines Amendment Act 2021), and
* substantial public interest in the legal foundations of major public health decisions,
* a detailed public interest assessment is required.

Please provide the reasoning behind your public interest evaluation.

4. Not all emails referencing s23 or provisional consent can be privileged.

Emails that are administrative, factual, or procedural fall outside legal professional privilege. I therefore request reassessment of the 915 emails identified, including release of:
* non-privileged content,
* attachments,
* forwarding notes, and
* factual summaries.

5. Potential waiver of privilege

Some legal reasoning regarding the Medicines Amendment Act 2021 and the s23 issue has already been publicly discussed by Ministers and officials. Please confirm whether Crown Law assessed whether privilege has been waived for any of the material.

Accordingly, I request:
* Reassessment of all documents and emails to identify material that is not privileged.
* Partial release or summary release under s16.
* A full explanation of your public interest balancing under s9(1).
* Confirmation of whether privilege was assessed for possible waiver.

If I do not receive a satisfactory response within 10 working days, I will seek review by the Office of the Ombudsman.

Yours sincerely,

John Armstrong