133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
12 June 2023
Sunil Williams
By email: [FYI request #22818 email]
Ref:
H203025372
Tēnā koe Sunil
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Haoura
(the Ministry of Health) on 15 May 2023. You requested:
The Ministry received this advice from Medsafe's manager of compliance Derek
Fitzgerald.
“If the ministry advocated that certain medicines be used off-label, this could come in for
criticism as a potential breach of the [Medicines Act 1981]... ... You may wish to obtain a legal opinion on the information the ministry publishes/wishes
to publish on this.” Until recently, the Ministry published advice to the public on its website in regard to the
safety and reversibility of chemical puberty blockade for treating childhood gender
distress. This is an off-label use of certain medicines. I am asking if the Ministry did seek legal advice in regard to its advocacy for this off-label
use. I am also asking for any documents pertaining to this advice. Including documentation of
requests made to, and responses from legal advisory.
Medicines currently used as puberty blockers in New Zealand may fall under the “unapproved
use of approved medicines” category. While they may not have Medsafe ‘approval’ for this use,
they can still be prescribed by authorised prescribers, if their patients are deemed to require the
treatment. You can read more about use of unapproved medicines or the use of approved
medicines for unapproved purposes here:
www.medsafe.govt.nz/profs/RIss/unapp.asp.
No legal advice has been identified in relation to advocacy for off-label use of puberty blockers.
Therefore, your request is refused under section 18(e) of the Act as the requested document
does not exist.
Please note, Manatū Hauora adjusted the website content regarding puberty blockers while an
evidence brief to support this area was being completed. The relevant evidence brief is currently
being prepared for release and is scheduled to be published in July 2023.
The September 2022 update to the website recognised that overseas jurisdictions were
reviewing the use of puberty blockers in their health systems particularly in younger people.
Any medical intervention carries a balance of benefit and risk that needs to be considered in
context by the person in partnership with their health professional.
It is important that health services meet the needs of all New Zealanders, with inclusiveness and
dignity for all. Manatū Hauora is committed to providing better access, support and safe
treatment for rainbow communities through our health system and ensuring the system is
responsive to the needs of transgender, intersex, and gender-diverse people.
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
Phil Knipe
Chief Legal Advisor
Government and Executive Services | Te Pou Whakatere Kāwanatanga
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