New Zealand’s regulation of medical products (including medicines and medical devices) has been in a state of flux for decades. The latest iteration, the proposed Medical Products Bill (the Bill), is due to be introduced into Parliament next year.
Last week, Cabinet released papers indicating the direction the Bill will take on key issues. This includes reducing restrictions on pharmacy ownership and maintaining the current approach allowing direct-to-consumer advertising of prescription medicines.
New Zealand’s legislation regulating medicines and medical devices is currently well over 40 years old. Efforts at reform have been ongoing for decades, yet none has made it to the finish line. In repealing the Therapeutic Products Act 2023 passed by the previous government, the current government signalled an intention to introduce new legislation in its place, the Medical Products Bill.
Cabinet considers the decisions outlined on the contents of the Bill will improve health outcomes and sector efficiency, while also “supporting economic growth and reducing unnecessary regulation.”1 In this article, we look at the key issues addressed in the Cabinet papers and what they might mean for stakeholders going forward.
Pharmacy ownership
Under the current Medicines Act 1981, there are significant restrictions on those who may own pharmacies. Specifically, to be granted a licence to operate a pharmacy:2
- an individual must be a pharmacist; or
- a company must, at all times, be under the effective control of one or more pharmacists, with those pharmacists owning more than 50 per cent of the share capital, unless one of a small number of exceptions apply.
In addition:
- No company may operate, and no person may operate or hold a majority interest in, more than five pharmacies.3
- Prescribers may not hold an interest in a pharmacy without Medsafe’s consent.4
What is required for pharmacists to possess effective control of a company in this context was the subject of a High Court decision in 2023, following which Medsafe issued further guidance in 2024.5
The recently-released Cabinet papers reveal a view that “assessing pharmacy ownership is not a good use of taxpayer money”, while the Associate Minister of Health advised that she had “seen no evidence that ownership restrictions protect public safety or help to maintain standards.” Instead, she considered that such concerns should be addressed through professional regulation, pharmacy licensing and Health New Zealand’s contracting processes.
As for the proposed Medical Products Bill, this would retain the current requirement that a pharmacist be physically present in each pharmacy. Beyond that, each company that includes more than one pharmacy would be required to have a “supervisory pharmacist”, with formal responsibility for the company’s compliance and ensuring pharmacy standards."6 The Cabinet paper suggests that this is similar to the UK system.7 The Bill would also make it an offence to encourage a pharmacist to act unprofessionally.8
If this approach is carried through into legislation, it should make structuring companies holding interests in pharmacies simpler, by removing the requirements for pharmacists to hold particular interests. We expect, however, that there will be a degree of oversight to ensure that the changes don’t impact on the standards at those pharmacies.
Medical advertising
New Zealand’s regime around medical advertising is often considered one of the most relaxed amongst comparable countries, given that prescription medicines may be advertised directly to the general public. This approach has come in for significant criticism in previous rounds of reform. Nevertheless, the government considers that the current regime “mostly works well”,9 and that they have “not seen any evidence that [direct-to-consumer advertising] causes significant harm.”10It will therefore be retained in the proposed Bill, albeit alongside powers to make regulations prohibiting specific advertising, such as of weight-loss products.
In addition, the proposed Bill would make a number of minor changes:
- Ensuring that there is one clear definition of the word “advertise”. Cabinet has signalled an intention to draw on the definition of “advertise” in the Australian Therapeutic Goods Act 1989. However, the exact wording will be finalised as part of the Parliamentary Counsel Office’s drafting process;11
- Making it clear that certain activities and materials do not count as advertising including news reporting, fundraising for a specific person (for example, Givealittle campaigns), advocating for policy change, public safety announcements and clinical trial recruitment material.
- Provide that, while medicines generally cannot be advertised for off-label/unapproved purposes, they can be so advertised at medical conferences and trade shows and where approved by the Director-General of Health.
This means it would largely be business as usual in the medical advertising space.
Other changes
The Medical Products Bill is also expected to:
- Provide for Medsafe to continue as the regulator of medical products. The Therapeutic Products Act 2023 would have introduced a new Therapeutic Products Regulator.12However, the government has decided that it would be “less expensive and less risky” to simply expand the existing regulator. The proposed Bill would also provide for levies, in addition to fees and Crown funding, to assist with the funding of the expanded Medsafe.
- Provide specifically for Medsafe’s ability to issue export certificates, confirming who the manufacturer is and that the product can be legally supplied in New Zealand. Exporters of medical products would be required to register with Medsafe. They would, however, be subject to only general duties such as around record-keeping. There would be no pre-approval of exporters by Medsafe.
- Continue the focus on timeframes for getting products to market, by allowing secondary legislation to set timeframes for decisions on medical products. A partial refund of fees would potentially be available if the regulator fails to comply with that timeframe.
- Update the offences and penalties regime.
Next steps
The Medical Products Bill remains under development, with the government indicating an intention to introduce it to Parliament next year.13We will continue to keep you updated on developments in this space.
If you have any questions about this article, please get in touch with the contacts listed or your usual Bell Gully adviser.
[1] Cabinet Office Circular “Medical Products Bill: reducing regulation and other policy matters” (13 October 2025) at [2].
[2] Medicines Act 1981, ss 55D and 55E.
[3] Medicines Act 1981, s 55F.
[4] Medicines Act 1981, s 42C
[5] Medsafe “Effective Control Principles” (1 October 2024) <https://www.medsafe.govt.nz/compliance/effective-control-principles.asp>.
The High Court decision is New Zealand Independent Community Pharmacy v Te Whatu Ora - Health New Zealand and Ors [2023] NZHC 1486.
[6] Cabinet Paper at [13]-[14].
[7] At [15].
[8] At [15].
[9] Cabinet Paper at [6].
[10] At [18].
[11] Therapeutic Goods Act 1989 (Australia) defines advertise, in relation to therapeutic goods or vaping goods, as including the making of “any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:
(a) is on the label of the goods; or
(b) is on the package in which the goods are contained; or
(c) is on any material included with the package in which the goods are contained.”
[12] Cabinet Office Circular “Modernising regulation of medicines and medical devices: high-level regulator settings” (13 October 2025) at [5].
[13] Hon Casey Costello (Associate Health Minister) Media Release (14 October 2025) “Medical Products Bill taking shape“ <https://www.beehive.govt.nz/release/medical-products-bill-taking-shape>
Disclaimer: This publication is necessarily brief and general in nature. You should seek professional advice before taking any action in relation to the matters dealt with in this publication.
