Legal advice and Cabinet papers regarding Pfizer/Comirnaty provisional consent and Medicines Amendment Act 2021
John Armstrong made this Official Information request to Department of the Prime Minister and Cabinet
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From: John Armstrong
Dear Department of the Prime Minister and Cabinet,
Pursuant to the Official Information Act 1982, I request the following information:
1/ Legal advice and internal correspondence between the Prime Minister and cabinet with Medsafe, the Ministry of Health, or 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 the Minister of Health on this legal risk.
4/ Cabinet papers, Cabinet minutes, and departmental 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 or ministerial briefings 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
From: Information [DPMC]
Department of the Prime Minister and Cabinet
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From: Information [DPMC]
Department of the Prime Minister and Cabinet
[IN-CONFIDENCE]
Kia ora,
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Ministerial Services
Strategy, Governance and Engagement
Department of the Prime Minister and Cabinet
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