Kia ora Nigel,

  

Thank you for your request under the Official Information Act 1982 (the
Act), received by the Ministry of Health - Manatū Hauora on 7 May 2026.
You requested:

 

"Under the Official Information Act 1982, I request the following
information relating to Medsafe’s use, interpretation, and communication
of the terms “safe”, “effective”, and “safe and effective” in the context
of medicines, vaccines, and public‑facing health communications.

 

1. Definitions and internal meaning of the terms

Please provide all documents, policies, internal guidance, briefing
material, assessment frameworks, communication frameworks, or other
records held by Medsafe that contain, describe, or apply any definition,
threshold, criterion, or internal meaning for the terms:

“safe”

“effective”

“safe and effective”

This includes any documents that define, operationalise, or otherwise
explain how Medsafe interprets these terms when assessing, approving, or
communicating about medicines or vaccines.

 

2. Internal guidance for the use of these terms in communications

Please provide all documents, emails, guidance, instructions, or
communication advice (internal or external) that relate to:

when Medsafe may or may not use the terms “safe”, “effective”, or “safe
and effective”

any criteria or thresholds that must be met before these terms are used

any risk‑communication considerations or constraints relating to these
terms

any advice provided to Health NZ, the Ministry of Health, or other
agencies about the use of these terms

 

3. Risk‑communication frameworks

Please provide all documents, frameworks, internal discussions, or
assessments held by Medsafe that relate to:

the appropriateness of using the terms “safe”, “effective”, or “safe and
effective” in public‑facing material

any risk‑communication analysis relating to the use of these terms

any consideration of whether these terms may be misleading, ambiguous, or
require qualification

 

4. Instructions or advice to other agencies

Please provide all documents, emails, or communications in which Medsafe:

instructed, advised, or guided Health NZ, the Ministry of Health, or any
other agency on the use of the terms “safe”, “effective”, or “safe and
effective”

provided wording, messaging, or communication guidance relating to these
terms

commented on the accuracy, appropriateness, or evidential basis for the
use of these terms by other agencies

 

5. Medsafe’s interpretation of the phrase “safe and effective”

Please provide all documents, internal discussions, or assessment material
that show:

how Medsafe interprets the phrase “safe and effective”

whether Medsafe considers this phrase to have a technical meaning

whether Medsafe considers this phrase to be equivalent to, or different
from, the statutory concept of a “favourable benefit–risk profile”

any documents that explain how Medsafe’s statutory assessment language
relates to the phrase “safe and effective” used in public communications

 

6. Records of cross‑agency alignment

Please provide any documents, emails, or discussions between Medsafe and:

Health NZ

Ministry of Health

Department of Conservation

Environmental Protection Authority

any other government agency

that relate to aligning, standardising, defining, or coordinating the use
of the terms “safe”, “effective”, or “safe and effective”." 

 

The reference number for your request is H2026082448. We will endeavour to
respond to your request as soon as possible and in any event no later than
5 June 2026 being 20 working days after the day your request was received.
If we are unable to respond to your request by then, we will notify you of
an extension of that timeframe.

 

If you have any queries regarding your request, please feel free to
contact the OIA Services Team on [1][email address]. If any
additional factors come to light which are relevant to your request,
please do not hesitate to contact us so that these can be taken into
account. 

 

Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [2][email address] or by calling 0800
802 602.

 

 

Ngā mihi, 
 
OIA Services Team

Ministry of Health | Manatū Hauora

 

M[3]inistry of Health information releases

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