Dear Medicines Classification Committee,

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

1/ Legal advice and internal correspondence between Medsafe and the Ministry of Health, and the Department of the PM and cabinet (DPMC), and Crown Law, 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, Crown Law and Ministry of Health.

4/ Medsafe 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