133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
10 May 2024
Catherine Jamieson
By email: [FYI request #26390 email]
Ref: H2024039361
Tēnā koe Catherine
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health – Manatū Hauora (the Ministry) on 10 April 2024. You requested:
“Has the Director General of Health, either past or present, been notified by the Accident
Compensation Corporation under Section 284(2) of the Injury Prevention, Rehabilitation,
and Compensation Act 2001 of any events, or series of events, it believes represent a
degree of ‘risk of harm’ to the public with regard to Covid 19 vaccines or preventative
medicines? Please provide any materials relating to that notification if it exists.”
You refer to section 284(2) of the Injury Prevention, Rehabilitation, and Compensation Act 2001:
www.legislation.govt.nz/act/public/2001/0049/4.0/DLM103407.html. which states:
If the Corporation believes, there is a risk of harm to the public, the Corporation must report
the risk, and any other relevant information, to the authority responsible for patient safety in
relation to the treatment that caused the personal injury.
Medsafe receives information from ACC on its risk of harm reporting under the legislation you
have quoted above. This responsibility is delegated to Medsafe by the Director-General of Health.
The information received from ACC covers adverse reactions to medicines and medical devices.
Any information which constitutes a valid adverse reaction report for the Centre for Adverse
Reactions Monitoring (CARM) database is entered into the database and reviewed with the
totality of the information in that database.
By making the CARM database accessible, individuals can gain insights into medicine safety and
potential risks associated with the products. However, it is pertinent to note that the information
that is accessible from the database is limited due to privacy considerations. A summary of
information for all adverse reactions in the CARM database is published here:
www.medsafe.govt.nz/Projects/B1/ADRDisclaimer.asp. This incorporates the information
Medsafe receives from ACC.
Prior to the health and disability reforms, there was a process where ACC would notify the
Director-General of Health of treatment injury decision which may present a risk of harm to the
public. For example, surgical mesh was reported to the Ministry, but this process has since
transferred to Health New Zealand – Te Whatu Ora.
Copies of notifications received by Medsafe from ACC are withheld under section 9(2)(a) of the
Act, to protect personal privacy. By safeguarding privacy, it encourages individuals to provide
accurate and detailed reports, which in turn enhances the quality and reliability of the data
collected. ACC has also published a response to an official information request regarding COVID-
19 vaccination injury analysis, which may be of interest to you:
www.acc.co.nz/assets/oia-
responses/IPA4784-Covid-Vaccination-Claims-Refresh-Nov21-FINAL.pdf
If you wish to discuss any aspect of your request with us, including this decision, please feel free
to contact the OIA Services Team on:
[email address].
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:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Manatū Hauora website at:
www.health.govt.nz/about-ministry/information-releases/responses-
official-information-act-requests.
Nāku noa, nā
Chris James
Group Manager
Medsafe
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