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[IN-CONFIDENCE]

 

Kia ora,

 

Thank you for your request under the Official Information Act 1982 (OIA)
received on 4 October 2025, copied below. We will respond to your request
within the statutory timeframes set out in the Act. If we are unable to
meet these timeframes we will notify you.

 

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Ngā mihi,

 

Ministerial Coordinator
Ministerial Services
Strategy, Governance and Engagement
Department of the Prime Minister and Cabinet
E    [2][DPMC request email]
 
 
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-----Original Message-----
From: John Armstrong <[FOI #32474 email]>
Sent: Saturday, 4 October 2025 3:29 pm
To: Information [DPMC] <[DPMC request email]>
Subject: Official Information request - Legal advice and Cabinet papers
regarding Pfizer/Comirnaty provisional consent and Medicines Amendment Act
2021

 

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

 

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Link: [7]File-List
Link: [8]Edit-Time-Data
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Link: [10]colorSchemeMapping

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The information contained in this email message is for the attention of
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communication of the Department of the Prime Minister and Cabinet. If you
are not the intended recipient you must not disclose, copy or distribute
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Link: [11]File-List
Link: [12]Edit-Time-Data
Link: [13]themeData
Link: [14]colorSchemeMapping

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The information contained in this email message is for the attention of
the intended recipient only and is not necessarily the official view or
communication of the Department of the Prime Minister and Cabinet. If you
are not the intended recipient you must not disclose, copy or distribute
this message or the information in it. If you have received this message
in error, please destroy the email and notify the sender immediately.

 

References

Visible links
1. mailto:[DPMC request email]
2. mailto:[DPMC request email]
3. mailto:[FOI #32474 email]
4. mailto:[DPMC request email]
5. https://fyi.org.nz/change_request/new?bo...
6. https://fyi.org.nz/help/officers
7. file:///tmp/Signature_files/filelist.xml
8. file:///tmp/Signature_files/editdata.mso
9. file:///tmp/Signature_files/themedata.thmx
10. file:///tmp/Signature_files/colorschememapping.xml
11. file:///tmp/Signature_files/filelist.xml
12. file:///tmp/Signature_files/editdata.mso
13. file:///tmp/Signature_files/themedata.thmx
14. file:///tmp/Signature_files/colorschememapping.xml

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