133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
30 January 2024
Geoff Reid
By email: [FYI request #25133 email]
Ref:
H2023033923
Tēnā koe Geoff
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 11 December 2023. Each part of your request is
responded to below.
“Please provide all data and information on the methodologies used by Medsafe that are
used to audit practitioners that are advertising and/or supplying unapproved
medicines/“therapeutic products" specifically but not restricted to intravenous vitamin C,
zinc, glutathione and B-dose.”
In preparing this response, the term ‘practitioner’ is interpreted as referring to a medical
practitioner and ‘practice’ is interpreted as referring to the medical practice of a medical
practitioner or a clinic operating under orders from a medical practitioner.
The reference to ‘therapeutic products’ in this instance is understood to refer to medicines.
The term ‘medicine is defined in sections 3 and 4 of the Medicines Act 1981:
https:/ legislation.govt.nz/act/public/1981/0118/latest/DLM53790.html
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and administers
the Medicines Act 1981. Medsafe does not have a regulatory function that requires it to audit
practitioners. Therefore, this part of your request is refused under section 18(g)(i) of the Act, as
the information requested is not held by the Ministry and there are no grounds for believing it is
held by another agency subject to the Act.
If Medsafe becomes aware of advertising of, or supply of medicines that may breach the
Medicines Act 1981, this may be investigated, and further action may be taken with those
responsible for the advertising or supply. Action can include providing information about the legal
requirements and advice on whether these are being complied with. Medsafe may also take
prosecution action in some instances.
“Please provide the number of warning notices that have been issued by Medsafe to
practitioners or practices advertising such substances in the last 2 years. How many of
those warnings have lead to legal action being taken?”
In the years 2022 and 2023, Medsafe did not issue any warnings. The Medicines Act 1981 does
not provide for the issue of warnings. This part of your request is therefore refused under section
18(g)(i) of the Act.
However, I have identified 11 instances in 2022, and 8 instances in 2023 where Medsafe
contacted prescribers, practices, or clinics in relation to regulatory issues. As the way information
is entered into the Medsafe database does not identify if the entry involves a practitioner or a
practice, these numbers are based on readily available information.
“Please prove how Medsafe, by auditing the sales price of ’therapeutic products’ is keeping
in alignment of their mission statement:
"To enhance the health of New Zealanders by regulating medicines and medical devices to
maximise safety and benefit.”
Medsafe does not have a role in either determining or auditing the prices of medicines. Therefore,
this part of your request is refused under section 18(g)(i) of the Act.
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
Derek Fitzgerald
Acting Group Manager
Medsafe
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