14 December 2023
Erika Whittome
[FYI request #24496 email]
Kia ora Erika
Your Official Information Act request, reference: GOV-029164
Thank you for your email of 22 November 2023, asking for the following information under the Official
Information Act 1982 (the Act):
1. Does ACC review the reports from the product' manufacturer on the product's adverse
events/effects?
2. In the case of a provisionally approved medicine (eg Fluvax, Comirnaty), does ACC review the Periodic
Safety Update reports from the manufacture? For example, this is a periodic safety report from Pfizer
on Comirnaty.
3. Does ACC review the post marketing report published by Pfizer in the case of Comirnaty for claims of
adverse events for this provisionally approved medicine? Ie this document.
Our response
ACC would most likely review such reports to assist in making a decision on providing cover for a treatment
injury claim relating to one of the specific medicines. As advised in our response of 16 November 2023
(our
ref: GOV-028541), cover decisions for treatment injury claims are made on an individual basis, and will take
into consideration any information and evidence relevant to the claim. This may include the reports and
other resources you have noted if they are relevant. Please refer to the policies provided in GOV-028541
for information about the treatment injury cover decision process and what information is used to make
those decisions. Noting this, ACC will review reports, such as those mentioned in your request, if they are
relevant to an individual treatment injury claim.
As this information may be of interest to other members of the public
ACC has decided to proactively release a copy of this response on ACC’s website. All requester data,
including your name and contact details, will be removed prior to release. The released response will be
made availab
le www.acc.co.nz/resources/#/category/12.
If you have any questions about this response, please get in touch
You can email me a
t [email address]. If you are not happy with this response, you can also
contact the Ombudsman via
[email address] or by phoning 0800 802 602. Information
about how to make a complaint is available at
www.ombudsman.parliament.nz.
Ngā mihi
Sara Freitag
Acting Manager Official Information Act Services
Government Engagement
GOV-029164 Page 1 of 1
Document Outline