133 Molesworth
Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
15 March 2023
Athina Andonatou
By email: [FYI request #21620 email]
Ref:
H2023020698
Tēnā koe Athina
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 21 February 2023 for information regarding the
Therapeutic Products Bil . The first part of your two-part request is as follows:
“1) Please send me the peer reviewed scientific papers that have been used to inform
the proposed changes to the Therapeutics Products BilI. The link you shared
https://www.health.govt.nz/our-work/regulation-health-and-disability-
system/therapeutic-products-regulatory-regime has the cabinet meeting minutes or
regulatory impact statements which is not what I've asked for.”
In responding to this part of your request, it will be helpful if I provide you with background
information about the development of the Therapeutic Products Bill. New Zealand’s
government, industry and practitioners have recognised for a number of years that our
regulatory regime for medicines and medical devices was becoming increasingly out of date,
not fit for purpose, inflexible and out of step with comparator countries. The Therapeutic
Products Bil 2022 (the 2022 Bill) was preceded by other initiatives to produce a regulatory
regime that was both fit for purpose and future-proof. Prior to the development of the 2022
Bil , the latest of these initiatives involved the development of the Therapeutic Products Bil
2018 (the 2018 Bil ), a draft of which was released for consultation in 2018.
A significant change between the 2018 Bil and the 2022 Bil involved the inclusion of natural
health products (NHPs) in the 2022 Bill. As with the regulatory regime for medicines and
medical devices, the need to reform New Zealand’s regulation of NHPs has been
acknowledged for over a decade. Current regulatory arrangements make it dif icult for New
Zealand’s NHP industry to export and innovate. They also do not provide an appropriate
level of assurance that products imported and supplied in New Zealand are safe for
consumers or made to the appropriate quality standards.
In response to these issues, a Natural Health Products Bil was introduced into Parliament in
September 2011. It progressed to the Commit ee of the Whole House before lapsing in
November 2017. Subsequent to the release of the 2018 Bil , the Government decided to
include NHPs within the scope of a new Therapeutic Products Bil . This decision recognised
that NHPs and other therapeutic products require similar regulatory schemes.
The information above shows that the provisions of the 2022 Bil , including those that apply
to NHPs, have been under active development for well over a decade. The development
process has been spread over multiple phases and has included input from industry and
consumer stakeholders, government officials and independent scientific advisors, as well as
from overseas experience and expertise. It is reasonable to assume that the many
individuals and organisations involved based their contributions on a variety of sources,
including peer reviewed scientific papers.
The significance of this information for your request is that providing you with “
the peer
reviewed scientific papers that have been used to inform the proposed changes to the
Therapeutics Products BilI” would involve a very substantial amount of research and
collation. Accordingly, this part of your request is refused under section 18(f) of the Act. This
section provides that a request may be refused if “the information requested cannot be made
available without substantial collation or research.”
The second part of your request is as follows:
“2) Please also provide me with how many people have died or been hospitalised due
to taking supplements or natural remedies in the last 10 years and the name of the
supplement or natural remedy that caused it.” The reply you provided to this question
gave me links to www.health.govt.nz/system/files/documents/information-
release/h2022018873_response.pdf. These are just general websites, I'm asking for
the exact evidence that is being used to inform the proposed changes to the
Therapeutics Products Bil , rather than general links.”
Manatū Hauora has already provided you with a previously released response under the Act.
This included reports of cases of suspected adverse reactions associated with dietary
supplements and herbal medicines received by the Centre for Adverse Reaction Monitoring
(CARM) from 2013-2021. You can access the CARM reports directly through this link:
www.medsafe.govt.nz/publications/OIA/20Dec2018ADRsCompMed.pdf.
I note that some information in this table which would have been relevant to your request
has been redacted under section 9 of Act, to protect the privacy of natural persons, including
that of deceased natural persons.
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-of icial-information-act-requests.
Nāku noa, nā
John McGrath
Director, Priority Projects
Strategy, Policy and Legislation | Te Pou Rautaki
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