133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
9 February 2023
Erika Whittome
By email: [FYI request #21071 email]
Ref:
H2023019798
Tēnā koe Erika
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Hauora
(the Ministry of Health) on 5 February 2023 as a follow up to information provided to you under
ref: H2022016442. You requested:
“This is a very interesting Ministry of Health response which says that Medsafe does not
perform any informed consent process. If Medsafe does not perform any informed consent process, then....
1 Are Medsafe allowed to discourage informed consent?
2. Are Medsafe allowed to discourage the consideration of risks of a medicine which are
outlined in a medicine's safety report?
Many Medsafe safety reports for Comirnaty say, "Medsafe advises people NOT to make
any decisions about vaccination based on information contained in this report. "
eg https://www.medsafe.govt.nz/COVID-19/safety-report-45.asp”
Your questions and the statements that support them appear designed to engage in a debate
about Medsafe’s involvement in the informed consent process, rather than a request for official
information. The Act does not support requests where an opinion, comment, argument, or
hypothetical statement is put to the Ministry for response, couched as a request for information.
As you have been advised, Medsafe is the New Zealand Medicines and Medical Devices Safety
Authority and is responsible for the regulation of therapeutic products in New Zealand. Medsafe
administers New Zealand legislation in relation to medicines. It is not a healthcare provider. As
Medsafe is not involved in the provision of healthcare to any individual patient, it does not perform
any informed consent process.
The statement you refer to from the safety reports is not related to an informed consent process.
The statement is included because the safety reports cover symptoms that are reported as
suspected to be related to a medicine and do not represent true side effects.
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.
Nāku noa, nā
Chris James
Group Manager
Medsafe
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