The Big Picture : Health

The Big Picture Health

DECEMBER 2025

Contents

Bell Gully

Four key legislative changes shaping the health sector

04

The Medical Products Bill – the overall approach

Countdown to change

05

The Medical Products Bill – pre-market controls

15 16

New Zealand health legislation – a timeline

06

The Medical Products Bill – post-market controls

18

Healthy futures? Revising The Pae Ora Act

07

More to come: the Natural Health Products Bill

21

Overhauling the Medicines Act – a new approach

09

Health – what else is on the way?

22

The start of change: the Medicines Amendment Act 2025

10

Our health practice

23

Wholesale reform: the Medical Products Bill

14

Our team

24

The Big Picture Health

2

Those doing business with New Zealand’s health sector should expect a busy year in 2026, with major reforms on the horizon.

Bell Gully

The Big Picture Health

3

Four key legislative changes shaping the health sector Healthy Futures (Pae Ora) Amendment Bill

Medicines Amendment Act 2025

•

Amends the Pae Ora (Healthy Futures) Act 2022 with the aim of increasing accountability and efficiency

•

Amends the Medicines Act 1981

•

•

Increased focus on infrastructure

•

Removes health sector principles and health charter

Provides a new faster approval pathway for medicines which have been approved by two overseas regulators (and not subsequently withdrawn)

•

Health NZ to engage with the Hauora Māori Advisory Committee rather than iwi-Māori partnership boards

•

Minor changes for unapproved medicines and advertising

Medical Products Bill

Natural Health Products Bill

•

Expected to be released in the first half of next year

•

•

Intended to replace the Medicines Act 1981 with a new riskproportionate regulatory framework aligned with internal approaches

The current government has been clear that it would regulate natural products separately from (and less intensively than) medical products

•

Expected to introduce pre-market approvals for medical devices and innovative products

•

Any Natural Health Products Bill would be a specific regulatory scheme for such products

•

Expected to loosen pharmacy ownership regulation

•

Timeframes for the Bill are currently unknown

Bell Gully

The Big Picture Health

4

Countdown to change The coming year promises to be busy for the health sector, with major reforms expected in the medical products space.

It has been a hectic few years for health.

There have been seemingly endless proposals for reform, although not all of them have lasted. That pace shows no sign of slowing next year. But will 2026 finally see the now-geriatric Medicines Act 1981 retired once and for all? And will the changes be just what the doctor ordered – or a prescription for more debate?

A major step will be amendments to the Pae Ora (Healthy Futures) Act 2022, to revise Health New Zealand’s objectives and remove the health sector principles currently set out in the legislation.

Understanding these changes will be important for those who do business with New Zealand’s primary public health entity, Health New Zealand | Te Whatu Ora. Next, the government has signalled that it will introduce a new Medical Products Bill, to replace the Medicines Act. This will build on work started by the Medicines

Amendment Act 2025 in adjusting settings around medicines, while also introducing pre-market regulation of medical devices.

The new Bill is also expected to make significant changes to the requirements for pharmacy ownership. This reform will be a key point of focus for anyone involved in the medical products space, although whether the proposed Bill can make it through the House before next year’s election remains unclear.

Meanwhile, it is business as usual in the natural health products space. The government signalled in 2024 that it would develop a standalone bill to regulate such products. But when this will materialise, and what it will look like, remain open to question.

Stakeholders may see some engagement from officials on this topic next year.

In the Big Picture: Health, we look at the key issues facing the sector and consider what they mean for those doing business in this area.

Bell Gully

The Big Picture Health

5

New Zealand health legislation – a timeline Indicative July 2023 Therapeutic Products Act 2023 passed. Provides for a new regime regulating medicines, medical devices, natural health products and activities relating to the supply of such products.

December 2024 Therapeutic Products Act repealed.

Consequence is that medicines and medical devices remain regulated by the Medicines Act 1981 (which provides very little regulation of medical devices), while some natural health products are subject to the Dietary Supplements Regulations 1985.

10 April 2025

2 July 2025

31 July 2025

Medicines Amendment Bill first reading.

Referred to Select Committee.

Healthy Futures (Pae Ora) Amendment Bill introduced to Parliament.

Select Committee reports back on the Medicines Amendment Bill.

4 November 2025

1 October 2025

Committee of the Whole House for the Medicines Amendment Bill.

Provision for advertising exemptions for medical conferences added, along with provisions removing the current restriction on prescribers holding interests in pharmacies.

Ministry of Health releases departmental report on the Healthy Futures (Pae Ora) Amendment Bill.

+

Following agreements reached at the last election in late 2023, Cabinet agrees to develop a new Medical Products Bill, and that natural health products should be regulated under a standalone bill.

Select Committee reports back on the Healthy Futures (Pae Ora) Amendment Bill.

Q3 to Q4 2026

Early 2026

2029/2030

Potential Select Committee process for the Medical Products Bill. There may be work on secondary legislation while the Bill is going through the House.

Expected introduction of the Medical Products Bill.

Possible implementation of any new Medical Products Bill, if it passes in early 2027.

+ +

+ September 2024

21 November 2025

31 March 2025

July 2025

Medicines Amendment Bill introduced. Adds a new verification pathway for medicines approvals, allowing medicines which have approvals from two overseas regulators to gain approval more quickly.

23 July 2025

Cabinet makes decisions on clinical trials, innovative medical products and software as a medical device as part of developing the Medical Products Bill. See page 14.

Bell Gully

First reading of the Healthy Futures (Pae Ora) Amendment Bill; referred to Select Committee.

The Big Picture Health

+

+

PHARMACY

August 2025 Cabinet makes decisions on pharmacy ownership and advertising of prescription medicines as part of the Medical Products Bill. See page 18.

21 October 2025

11 November 2025

Second reading of the Medicines Amendment Bill.

Medicines Amendment Act 2025 passes the house; receives royal assent 18 November.

6

Late 2025 / early 2026 Expected passage of Healthy Futures (Pae Ora) Amendment Bill.

2026 Potential engagement on a Natural Health Products Bill, although timing is currently unknown.

PHARMACY

Late Q4 2026 to early 2027 Potential passage of the Medical Products Bill.

Otherwise, it will likely need to wait for the next parliamentary term.

Healthy futures?

Revising the Pae Ora Act The Pae Ora (Healthy Futures) Act 2022 (the Pae Ora Act) defines the structure of New Zealand’s health sector. Passed under the previous government, it established Health New Zealand | Te Whatu Ora as the principal agency responsible for running the health system across the country.

Timely access and better infrastructure

The Healthy Futures (Pae Ora) Amendment Bill (the Healthy Futures Bill) entered Parliament in July. It proposed changes to the Pae Ora Act to make the health system “more accountable, more efficient, and focused on delivering better outcomes for patients”.1

Firstly, the Healthy Futures Bill seeks to update the Pae Ora Act’s purpose to include ensuring that “patients get timely access to quality health services”. This will join other purposes such as protecting, promoting and improving the health of all New Zealanders and achieving equity in health outcomes among New Zealand’s population groups.

A key focus of the amendments is to deliver timely access to health services and provide for future infrastructure.

Secondly, the Bill proposes to amend Health NZ’s objectives. Currently, those objectives include to design and deliver services in accordance with the health sector principles. With the removal of those principles, which we discuss later, Health NZ’s objective will instead become to design and deliver “appropriate, effective, and

Bell Gully

The government is amending the key legislation setting out the structure of New Zealand’s health system. But will the changes lead to a healthier future?

timely services” to achieve the Pae Ora Act’s purpose. The Bill will add an objective “to provide and plan for quality, cost-effective, and financially sustainable infrastructure to deliver services to New Zealanders,” with a similar amendment made to its functions.

Both the objectives and functions will also be amended to make clear that Health NZ should collaborate with private healthcare providers.

Finally, the Healthy Futures Bill will require Health NZ to establish an infrastructure committee. The purpose of that committee will be to provide and plan for infrastructure to deliver health services. As with many of the other changes, this amendment signals a focus on improving physical health infrastructure. Stakeholders can expect to see an increased focus on this from Health NZ in the near future.

The Big Picture Health

7

Healthy futures?

Revising the Pae Ora Act

Removing the health sector principles and health charter

Hauora Māori Advisory Committee

Other changes

The Healthy Futures Bill seeks to remove the health sector principles from the Pae Ora Act. Under the current Act, decision-makers must be guided by these principles when performing a function or exercising a power or duty. The principles encompass health sector equity, engagement with Māori and other population groups, provision of opportunities for Māori to exercise decision-making authority and choice of quality services for Māori and other population groups. These will be removed under the proposed Bill.

At present, Health NZ is required to engage with iwi-Māori partnership boards. There are 15 such boards, aimed at ensuring Māori voices are heard in decision-making.

The Bill also makes a number of other changes, including:

The Healthy Futures Bill would amend this structure, with iwi-Māori partnership boards instead reporting any insights they gain from engaging with their communities to the Hauora Māori Advisory Committee. Health NZ would then be required to engage with that committee and take its advice into account.

The Pae Ora Act also provides for a New Zealand Health Charter, being a statement of values, principles, and behaviours that health entities and workers are expected to demonstrate. The Healthy Futures Bill will repeal these provisions, removing the need for a Health Charter.

•

Making it clear that provisions around political neutrality apply to Health NZ, and that the Minister must only appoint people to its board who the Minister considers have the appropriate experience.

•

Providing that the Director-General of Health can attend any of Health NZ’s meetings.

•

Requiring details of how key services will be funded, and a statement of anticipated revenue and expenditure, in the New Zealand Health Plan.

The Healthy Futures Bill – timing The Healthy Futures Bill had its first reading on 22 July and was referred to the Health Select Committee. Oral submissions on the Bill were held in September, with the Committee’s report issued on 21 November, recommending only minor changes to the Bill (although opposition parties dissented). From here, it will need to pass through its second reading, committee of the whole house stage and third reading before becoming law. This will most likely occur sometime early next year.

Bell Gully

The Big Picture Health

8

Overhauling the Medicines Act – a new approach

At nearly 45 years old, the Medicines Act 1981 is long overdue for an overhaul. The current Act has failed to keep pace with technological advances or international changes. There is little flexibility to regulate novel technologies, while regulation of medical devices is severely limited, putting New Zealand out of step with much of the world.

A new Medical Products Bill is expected in 2026. Those involved with medicines and medical devices should ensure that they are across the wide-ranging changes proposed.

Cabinet has therefore proposed to introduce a new Medical Products Bill to Parliament in 2026. This would seek to provide modern, risk-proportionate regulation of therapeutic products without creating unnecessary red tape. Historically, however, changing the Medicines Act has proven no easy feat.

Multiple attempts at reform have so far failed to generate change.

HISTORY OF THE REFORMS The Medicines Act has been slated for reform for decades. A proposal for joint regulation between New Zealand and Australia foundered in the 2000s.2 Subsequent efforts to develop New Zealand-specific legislation have similarly gone nowhere. A Therapeutic Products Bill, addressing medicines, medical devices and eventually natural health products, entered development in 2015 and was consulted on in 2018-2019. This ultimately became the Therapeutic Products Act 2023.

However, the last election saw commitments from all governing parties to repeal the Therapeutic Products Act due to concerns that it would lead to overregulation of low-risk products, impose unnecessary costs and raise barriers to accessing medicines and other medical products. Instead, the government said it would introduce a new Medical Products Bill with a different approach to reform.

The Therapeutic Products Act Repeal Bill passed through Parliament in 2024, removing the Therapeutic Products Act from the statute books before it ever came into force. In its absence, the Medicines Act and associated regulations continue to apply to medicines and medical devices – until such time as new legislation is passed.3

Bell Gully

The Big Picture Health

9

The start of change: the Medicines Amendment Act 2025

The government has sought to advance this element ahead of its more extensive reforms.

The Medicines Amendment Bill was introduced into Parliament on 31 March 2025 to amend the Medicines Act 1981 to: • introduce a streamlined verification pathway for medicines approvals in line with the coalition agreements; and • update prescribing settings to allow for broader prescribing of unapproved medicines.

That Bill has since been enacted in November 2025, becoming the Medicines Amendment Act 2025. The government has signalled its intention for the verification pathway to be in place by early 2026.

NEW VERIFICATION PATHWAY – A “RULE OF TWO” The Medicines Amendment Act will introduce a new consent by verification pathway, enabling the Minister to consent to the sale, distribution and advertising of a new medicine, based on a “Rule of Two”: where two regulators have given their approval to a medicine.

According to the Medicines Amendment Act, the Minister would be able to provide consent under the verification pathway where they are satisfied that the new medicine meets the following conditions:5

Have a full full marketing authorisation from two or more recognised regulatory authorities. A full marketing authorisation is one based on a complete evaluation by that recognised regulatory authority, and would not include any evaluation which is abbreviated, abridged or which relied on another evaluation. It also would not include any provisional, conditional or export-only authorisation.

The medicine must:

In addition to repealing the Therapeutic Products Act, coalition agreements at the last election included a commitment to “[r]equire Medsafe to approve new pharmaceuticals within 30 days of them being approved by at least two overseas regulatory agencies recognised by New Zealand.”4 The intention was to reduce barriers to medicines entering the market, noting that many medicines supplied in New Zealand will have already been approved overseas.

Be “identical in all material respects” to the medicine which has received the relevant overseas marketing authorisations.

Not require an independent assessment by the Director-General of Health to consider the benefit-risk profile in context, whether because of “local disease epidemiology, public health considerations, or New Zealand specific health risks”. This provides an off-ramp from the expedited process if there are concerns that the medicine requires a New Zealand-specific assessment.

Not have had its full marketing authorisation rejected or withdrawn by a recognised regulatory authority for reasons concerned with quality, safety or efficacy.

Have been subject to any regulatory action which may result, or has resulted, in a suspension or revocation of market authorisation by a recognised regulatory authority.

Bell Gully

The Big Picture Health

10

There will be scope for additional requirements for consent by verification to be set out in rules. These may include rules to ensure manufacturing sites have evidence of Good Manufacturing Practice, or, where a product is a generic prescription medicine, that the new product is identical to one already approved in New Zealand.6 Recognised regulatory authorities will be identified by notice in the Gazette. To be eligible to be a recognised regulatory authority, there are a number of criteria an overseas body must satisfy.

The regulatory authorities whose approval is relied on must:

The start of change: the Medicines Amendment Act 2025

Regulate medicines.

Operate in a regulatory framework similar to that provided in New Zealand legislation in relation to the matters they must take into account and their decision-making process.

Have a formal framework for co-operation with the Director-General.

Use international guidelines and standards in relation to medicines which are consistent with those used under the Medicines Act.

Originally, the Medicines Amendment Bill would have expressly set out which bodies constituted recognised regulatory authorities, meaning that the list could only have been amended by Parliament. However, the Select Committee considered this would prevent the legislation from adapting to a “rapidly changing global context”. It preferred to give the Minister flexibility to recognise such bodies by appointing them through a Gazette notice.7 The Minister must make a decision regarding whether to grant consent by verification within the time period specified in the rules (with that period commencing on the day the fees for the application are paid). While the rules have yet to be issued, this timeframe will presumably align with that promised in the coalition agreements – 30 days. There are also provisions for the Minister to suspend or revoke consent where the requirements for consent may no longer be met.8

Conduct their business/release reports in English.

Bell Gully

The Big Picture Health

11

The new verification pathway will be an addition to two existing options:

Full assessment pathway This applies where a medicine has not been subject to a complete assessment overseas and involves a comprehensive assessment of the new medicine.

Abbreviated assessment pathway This is available where a medicine already has one approval from a trusted regulator. This pathway is cheaper and generally faster than the full assessment.

UNAPPROVED MEDICINES

FURTHER CHANGES

The Medicines Amendment Act will expand the circumstances in which unapproved medicines – those which have not be approved for sale, distribution or advertising in New Zealand – can be prescribed. Doctors can already prescribe an unapproved medicine to treat a specific patient under the Medicines Act. But the 2025 Act would also mean:

When the Medicines Amendment Bill passed through the Committee of the Whole House on 4 November 2025, further changes were made to:

1.

All authorised prescribers can prescribe unapproved medicines where there is a shortage of an approved medicine, provided the unapproved alternative is funded by Pharmac.

2.

Nurse practitioners will be able to prescribe unapproved medicines for other reasons, as doctors can presently. However, practitioners will continue to be limited to prescribing medicines within their scope of practice, and their profession’s specified list.

•

Enable advertising exemptions for medical conferences. If the organiser of a medical conference, where the intended audience is health practitioners, notifies the DirectorGeneral of Health of various matters at least 30 working days before the conference opens, then the prohibition on advertising the availability of unapproved medicines won’t apply to those advertising at that conference.

•

Repeal the provision of the Medicines Act which prevents prescribers from holding interests in pharmacies without Medsafe’s consent.

This means it will be easier for suppliers of established medicines to enter the New Zealand market and somewhat easier for patients to access unapproved medicines.

The Medicines Amendment Act – what next?

With the Bill now passed, notices will need to be issued identifying the overseas regulators whose approval may be relied upon. That is expected to happen quickly, with the new pathway up and running either at the end of 2025 or the beginning of 2026.

Bell Gully

The Big Picture Health

12

A new prescription - for medical products Bell Gully

The Big Picture Health

13

WHolesale reform: the Medical Products Bill

Where the Medicines Amendment Bill tweaks existing legislation, the Medical Products Bill represents wholesale reform.

As with previous attempts at reform, the Medical Products Bill will provide pre- and post-market regulation for medicines and medical devices, with provision for innovative products as well. For medicines, which are already subject to pre-market approvals, the changes are likely have less of an impact (although major changes to the ways in which pharmacies are organised are expected, as detailed later).

Regulation of medical devices, however, is likely to change significantly.

Pre-market approval – product treatment9

At present, medical devices are not subject to premarket approval. Instead, sponsors – those responsible for a device – merely need to notify Medsafe of certain basic information within 30 working days of becoming sponsor of that device. Cabinet has recognised that this approach “carries a level of risk”. Devices could potentially be supplied in New Zealand which have not been approved elsewhere, or which don’t meet appropriate quality standards.10 The Medical Products Bill will therefore introduce a (risk proportionate) pre-market approval regime that includes medical devices, as detailed below.

Software as a medical device (SaMD)

In •

Medicines

•

Medical devices

•

Software that is part of a medical device (e.g. a pacemaker)

•

Software as a medical device (including some uses of AI)

•

Vitamins and minerals above a certain level (aligned with international standards)

•

Advanced cell and gene therapies

•

Substances of human origin (blood products, organs etc.)

Out •

Food and drink

•

Vitamins and minerals below a certain level

TBC

•

Other natural health products, including rongoā Māori (regulated under their own legislation)

•

Most cosmetics and related items, such as shampoo or face wash

•

Equipment that can benefit health, e.g. sports gear

•

Software used in a medical setting, e.g. patient booking software

Bell Gully

•

Radiopharmaceuticals

•

Sunscreen

A key issue overseas has been the treatment of software.

Currently, some software may meet the definition of a medical device, in that it is intended to be used for human beings for a therapeutic purpose. However, at present, the Medicines Act regime contains no software-specific requirements – for example, there is no obligation on manufacturers to meet basic cyber-security or privacy obligations. This is despite software issues being a common cause of device recalls in Australia.11 There may also be some confusion as to when software is itself a medical device, rather than a constituent part of another medical device.

Cabinet papers suggest that the Medical Products Bill will look to address this deficit, by clearly providing for software used for a medical purpose to be a medical device. In doing so, it will draw on internationally accepted definitions.12 That means the Bill is likely to capture software used in clinical decision-making, including artificial intelligence software, such as AI which analyses medical imagery.

Those involved with such software will want to keep a keen eye on the reforms to see how it is ultimately regulated.

The Big Picture Health

14

The Medical Products Bill – the overall approach

The government has said it will ensure regulation:

1 2

The Medical Products Bill is intended to:13 •

Support improved health outcomes for all New Zealanders through timely access to safe, high quality, and effective medical products.

•

Provide “cost-effective assurance that medical products meet acceptable standards of safety, quality, and efficacy or performance.”

Is risk proportionate.

3

The Medical Products Bill will provide for comprehensive regulation of products across their life cycle by imposing controls both before and after their introduction to the market.

Recognises the differences between different product types (including specifically the differences between medicines and medical devices).

4 5 Bell Gully

Supports timely access to medical products.

The Big Picture Health

Is harmonised as far as possible with international good practice, including relying on assessments/decisions by trusted overseas regulators, adopting common standards and comparable definitions to those used overseas.

Supports innovation, economic growth and exports in a way which maintains New Zealand’s reputation.

15

The Medical Products Bill – pre-market controls A key feature of the Medical Products Bill is the introduction of at least some form of pre-market control for all relevant products. In doing this, a key focus for the government will be to ensure that regulation is riskproportionate: that the highest risk products are subject to the most intensive regulation, while lower-risk products receive a lighter-touch approach.

To this end, Cabinet has signalled that the Bill will:14

HIGHEST RISK Require New Zealand approval for medicines, as is the case now, with the addition of the faster verification pathway carried over from the Medicines Amendment Act 2025.

Enable manufacturers of high- and mediumrisk medical devices which have not been approved overseas to seek an assessment based on the device’s nature and risk profile.

MEDIUM RISK

LOWEST RISK

Enable high- and medium-risk devices to be approved based on approvals from trusted overseas regulators (an approach similar to the new verification pathway for medicines).

Bell Gully

Enable low-risk devices to be approved based on the sponsor declaring their compliance with relevant standards, and acceptance of their responsibilities as sponsor.

Such declarations of conformity are already used for the lowest-risk devices overseas. Here, the intention is that local requirements would be limited to matters such as New Zealand labelling requirements.

The Big Picture Health

Introduce a mechanism to add new pathways for innovative products.

16

The Medical Products Bill – pre-market controls

Regulation of low-risk devices would therefore be reasonably light-touch, requiring only that sponsors confirm their compliance without any routine external checks. Suppliers of devices posing higher risks would either need to show they had received approval overseas or go through a New Zealand process. The details of these processes will likely be revealed in secondary legislation.

For other activities, such as manufacturing, Cabinet has indicated that if industry participants are involved with globally recognised quality assurance programmes, those programmes will be recognised as meeting local requirements.15 The Bill is also intended to include flexible provisions enabling processes to be approved rather than end products, to expedite approvals for products which might be manufactured for specific patients (for example, dental crowns).

Bell Gully

INNOVATIVE PRODUCTS

TIMEFRAMES

In addition to introducing pre-market regulation for medical devices, Cabinet has signalled an intention for the Medical Products Bill to allow new approval pathways for innovative products. These will largely be developed via secondary legislation sitting underneath the Bill, so the details will not be known for some time. However, Cabinet indicated there will be scope for assessment and evaluation criteria to be altered to account for innovative products, and provisions allowing conditional approvals (which will require the sponsor to submit further clinical data within a certain period).

There would also be provisions to enable pilot programmes under controlled conditions, and to introduce a power for Medsafe to establish joint working committees with other regulators, both in New Zealand and internationally, to assess new technologies.16 For biologics, there will be differentiation between minimally-manipulated biological products and those that are more than minimally manipulated.17

The Bill is expected to provide for secondary legislation that sets timeframes for decisions on medical products. Where appropriate, a partial refund of fees may be available where the regulator fails to comply with those timeframes.

The Big Picture Health

17

The Medical Products Bill – postmarket controls In addition to pre-market approval requirements, the Medical Products Bill will include a number of other controls. To engage in activities involving medical products (such as their manufacture, supply, or prescription), a person will require one of the following: •

A professional registration – healthcare practitioners prescribing medicines will largely be regulated via their professional registration.

•

A licence or permit – manufacturing and wholesale of medical products will likely be governed by a system of licences and permits.

•

Other authorisation in legislation – the Bill is likely to include permissions for certain routine healthcare activities.

Cabinet papers note this is “out of step with comparable countries and creates a high level of risk for the public and healthcare providers”.18 It also makes it difficult to respond to problems which arise.

That said, the government considers that the Therapeutic Products Act went too far in how it proposed to regulate this area. It is therefore proposing a "risk-proportionate registration and notification system” for manufacture, import and distribution activities relating to devices. Details of what this may look like have not yet been released.

Other key aspects In addition to the overarching structure of the regime, Cabinet has made decisions on a number of other key elements.

PHARMACY REGULATION Cabinet has decided to change current requirements around pharmacy ownership.

At present, to be granted a pharmacy licence, an individual must be a pharmacist, while a company must generally be under the effective control of one or more pharmacists, with those pharmacists owning more than 50% of its shares. No company can operate more than five pharmacies, nor can any person operate (or hold a majority interest in) more than that number.19

Cabinet has decided to remove these restrictions, on the basis that assessment of pharmacy ownership was not a good use of taxpayer funds, and that evidence regulations operate to protect the public or maintain standards was lacking. All pharmacies will still be required to have a pharmacist physically present on site, and the new legislation will require each company that includes multiple pharmacies to have a “supervisory pharmacist”. That person will have formal responsibility for ensuring the company’s compliance with pharmacy standards.

ADVERTISING The Medical Products Bill will retain the current approach of allowing direct-toconsumer advertising. The government considers the current regime “mostly works well”.20 However, the definition of “advertise” will be amended to ensure there is a single, clear definition, likely to be based on what is set out in the Australian Therapeutic Goods Act 1989.

That defines advertising as 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” is present on the product’s label, packaging, or any material included with the packaging. The legislation would also make clear that certain activities are excluded from the definition of

advertising, including news reporting, trade shows and fundraising efforts to benefit individual patients.

CLINICAL TRIALS Regulation of clinical trials is currently inconsistent, with no regulation of medical device trials or clinical trial sites or providers.

In contrast, the government considers clinical trials for some medicines to be over-regulated, creating unnecessary administrative delays. As a result, it is proposing risk-based pathways for authorising medicine/medical device trials based on the risk class of the product in question. Lowerrisk trials may be subject to a notification pathway, while higher-risk trials would need to go through an approval process.

As with other areas of the legislation, the Bill would allow reliance on authorisations granted by overseas regulators. There would be provision for monitoring clinical trials, including site inspections,21 and sites and trial providers would also be subject to risk-proportionate notification/registration processes. There would be registration of clinical trials on a public register. Assessment of clinical trial protocols would be taken away from the Health Research Council because of the conflict with its role in providing public funding for research, and given to Medsafe instead.

For medicines, this approach would not be a significant change. But at present, manufacturing and other activities in relation to medical devices are largely unregulated.

Bell Gully

The Big Picture Health

18

The Medical Products Bill – post-market controls

The government has indicated that it doesn’t agree with the requirement in the now-repealed Therapeutic Products Act that products intended solely for export obtain a product approval. Instead, there will be an export certification regime.

EXPORT CERTIFICATE This will continue on from Medsafe’s current practice of issuing export certificates and will be specifically provided for in the Bill.

Exporters will also be required to register – this is expected to assist in protecting New Zealand’s international reputation but without imposing significant burdens on exporters. Registered exporters would also need to comply with general duties such as recordkeeping obligations.

Bell Gully

The Big Picture Health

The Medical Products Bill – timing Earlier Cabinet papers suggest that the government’s intention was for the Medical Products Bill to be introduced in late 2025, passed in 2026 and to come into effect in 2028.22 More recent communications suggest that the Bill won’t be introduced until next year.

Once introduced, the Bill will need to go through its first reading and to Select Committee, a process which usually takes around six months.

For such complex legislation, that full six-month period is likely to be needed. There is an open question as to whether the government will attempt to pass the Bill prior to the next election, expected in late 2026, or whether medical product regulation will again have to wait for the next parliamentary term.

19

Looking ahead to - natural health products reform Bell Gully

The Big Picture Health

20

More to come: the Natural Health Products Bill Like medicines, natural health products are currently regulated by old legislation.

The Dietary Supplements Regulations 1985 (which fall under the Food Act 2014) impose limits on the concentration of vitamins and minerals certain products can contain. However, there is no requirement for a regulator to review those products before they enter the market. Nor is there any ability for such products to claim a therapeutic purpose – if they did, they would be treated as a medicine and need to be reviewed

by Medsafe.

The Therapeutic Products Act would have regulated both medical and natural health products. Even before it was repealed, Cabinet agreed in September 2024 that natural products should be regulated under a standalone Natural Health Products Bill. They will not be regulated by the Medical Products Bill.

It remains unclear what the Natural Health Products Bill will look like.

The Ministry of Health’s website advises that its current priority is the development of the Medical Products Bill. A draft Natural Health Products Bill will likely need to wait for a new parliamentary term. In the interim, changes have been made to the handling of export exemptions for composition and labelling requirements to help suppliers, including of dietary supplements, meet importing country requirements.

Bell Gully

The Big Picture Health

21

Health – what else is on the way?

There are a number of other key developments expected over the next year.

A continued focus on health infrastructure Budget 2025 set aside over NZ$1 billion for health infrastructure, including redeveloping Nelson Hospital and Wellington’s Emergency Department. Infrastructure is also a key focus of the amendments to the Pae Ora Act. We expect this focus on long-term infrastructure investment to continue into next year.

Completion of the Health NZ ‘turnaround’ Health NZ is targeting entering a more ‘settled’ state by July 2026, and exiting financial deficit somewhere in 2026-27.

We expect continued progress towards the seven priorities in its Updated Health Delivery Plan, including improved access to, and reduction of, waitlists, adherence to budget and improved value for money, and modernisation of the infrastructure used to deliver health services.23

A focus on health targets In 2024, the government announced health targets of: faster access to cancer treatment; improved childhood immunisation rates; shorter stays in emergency

departments; and shorter wait times for first specialist assessments and elective treatment. These targets came into effect on 1 July 2024, and are reflected in the Government Policy Statement. A further primary care health target was announced in July 2025, requiring that more than 80% of people be able to access a GP appointment within a week of seeking one. This will come into effect in July 2026.

Amendments to legislation governing health practitioners In September 2025, the Minister of Health announced an intention to amend the primary legislation governing the health workforce, the Health Practitioners Competence Assurance Act 2003. These amendments would: •

Increase the Minister’s powers to direct workforce regulators.

•

Increase transparency and accountability of those regulators, including by requiring them to issue statements of intent and performance expectation.

•

Set up a streamlined process for reviewing regulators’ decisions regarding a practitioner’s registration.

Officials are now working to draft a bill to implement these aims.

Bell Gully

The Big Picture Health

Possible movement on gene technology Gene technology or genetic engineering has implications for healthcare. At present, gene technology is regulated by the Hazardous Substances and New Organisms Act 1996, with any new organism requiring approval from the Environmental Protection Authority (EPA). A new Gene Technology Bill would establish a new regulator within the EPA to assess and manage risks from genetically modified organisms and provide advice and guidance. The Bill was introduced last year, with the Select Committee issuing its final report on 10 October 2025. Notably, all parties, aside from National, opposed at least one aspect of the Bill.

That means there is a clear question about what happens next, and when any new Bill would complete its passage through Parliament.

Contracts for Insurance In passing the Contracts of Insurance Act 2024, the government opted not to explicitly ban or restrict insurers from using genetic test results in underwriting for life or health insurance. However, the Act gives the government the ability to issue regulations imposing restrictions. The Act is not yet in force, requiring an Order in Council, but has a long stop commencement date of 15 November 2027. Those involved with insurance will want to keep an eye on this space.

22

Our health practice HEALTH-SECTOR SPECIFIC EXPERTISE As the health sector continues to face new challenges in New Zealand, understanding the evolving regulatory and legal environment is essential. We provide clear, practical advice on issues shaping the sector, with specialist expertise around procurement, and the statutory and regulatory framework.

We have worked on a broad spectrum of health issues, advising clients from Pharmac to major health providers, commercial operators, and medical industry entrants looking to establish a presence in New Zealand.

Our experience includes advising on purchasing strategies, tender processes and contracting for a number of New Zealand’s leading health providers. This has included drafting a landmark agreement that secured funding for the largest number of new medicines under a single arrangement : advising officials from MBIE, the Ministry of Health, Pharmac, MFAT and The Treasury on securing a portfolio of COVID-19 vaccines.

We advise Crown entities on their contracting with health providers, and private sector clients on how medicines and medical devices regulation applies to them. We have been involved with key regulatory aspects of New Zealand’s health system including advising on the development of the New Zealand Public Health and Disability Act and the Human Rights Act implications of decision criteria for rationing health funding. We are now closely monitoring health sector reform, with an eye on emerging risks and opportunities for clients.

• Regulatory issues • Service provision contracts • Pharmaceutical concerns • Medicines approvals and medical device issues • Medicine advertising requirements • Privacy obligations under the Health Information Privacy Code • Dispute resolution • Financing • Taxation • Reorganisation • Asset transactions • Joint ventures • Judicial reviews • Employment • Licensing and regulatory issues • Clinical trials • Insurance

Bell Gully

The Big Picture Health

23

Our team Authors

Kirsty Dobbs

Dr. Laura Hardcastle

PARTNER

SENIOR ASSOCIATE

DDI +64 4 915 6514 MOB +64 27 405 8086

DDI +64 4 915 6870 MOB +64 21 876 965

kirsty.dobbs@bellgully.com

laura.hardcastle@bellgully.com

REGULATORY ADVICE-HEALTH/ DISPUTE RESOLUTION

REGULATORY ADVICE-HEALTH/ DISPUTE RESOLUTION

Acknowledgments

Rachael Brown

Laura Littlewood

PARTNER

PARTNER

DDI +64 4 915 6882 MOB +64 21 390 383

DDI +64 9 916 8928 MOB +64 21 828 429

rachael.brown@bellgully.com

laura.littlewood@bellgully.com

REGULATORY ADVICE-HEALTH/DISPUTE RESOLUTION/EMPLOYMENT

MARKET ENTRY/COMMERCIAL CONTRACTING

Liz Coats

Anna Buchly

PARTNER

PARTNER

DDI +64 9 916 8732 MOB +64 21 418 483

DDI +64 9 916 8649 MOB +64 21 622 555

liz.coats@bellgully.com

anna.buchly@bellgully.com

EMPLOYMENT

M&A

Ian Becke

Scott Lochhead

PARTNER

PARTNER

DDI +64 9 916 8795 MOB +64 21 804 096

DDI +64 9 916 8689 MOB +64 21 228 4574

ian.becke@bellgully.com

scott.lochhead@bellgully.com

CONSTRUCTION AND PROJECTS

CONSTRUCTION AND PROJECTS

Glenn Shewan

Sam Hiebendaal

PARTNER

Our thanks to Bell Gully graduate Minna Reid and lawyers Anna Snow and Caroline Enright for their contributions to relevant sections of this report

Bell Gully

PARTNER

DDI +64 9 916 8726 MOB +64 21 828 926

DDI +64 9 916 8961 MOB +64 21 318 684

glenn.shewan@bellgully.com

sam.hiebendaal@bellgully.com

COMPETITION

INSURANCE

The Big Picture Health

24

Endnotes

1. Hon Simeon Brown “Putting patients first: Government to refocus health system on outcomes” (press release, 14 June 2025). https://www.beehive.govt.nz/release/ putting-patients-first-government-refocus-healthsystem-outcomes 2. Stacy Kirk “NZ, Australia abandon joint medicine agency” Stuff (New Zealand, 20 November 2014 https://www.stuff.co.nz/national/politics/63384946/nzaustralia-abandon-joint-medicine-agency 3. More info on the status quo: Therapeutic Products: Business as usual for the moment but the rationale for reform remains - Bell Gully 4. “Coalition Agreement of the 54th Parliament, New Zealand National Party & New Zealand First” (Coalition Agreement - New Zealand First (nzfirst.nz)), at 8. https://www.nzfirst.nz/coalition-agreement 5. Medicines Amendment Bill 2025 (134-1), cl 7 inserting s 22C. 6. Hon David Seymour “Rule of Two for faster access to medicines” (press release, 3 April 2025). https:// www.beehive.govt.nz/release/rule-two-faster-accessmedicines 7. Medicines Amendment Bill 2025 (134-1) (select committee report) at 2.

8. Medicines Amendment Bill 2025 (134-1), cl 7 inserting s 22E.

9. This work, "Documents relating to the Medical Products Bill" is adapted from the graphic with the same name by Ministry of Health NZ, used in Medical Products Bill webinar. The graphic is licensed under CC BY 4.0 by Bell Gully. https://www.health.govt.nz/ regulation-legislation/medicines-legislation/regulatingmedicines-medical-devices-and-natural-healthproducts/documents-on-the-medical-products-bill 10. Ministry of Health and Cabinet Social Outcomes Committee “Modernising regulation of medicines and medical devices” (11 October 2024) Cabinet Paper at [17]-[19]. https://www.health.govt.nz/informationreleases/cabinet-material-modernising-the-regulationof-medicines-and-medical-devices 11. Ministry of Health and Cabinet Social Outcomes Committee “Supporting innovation through the Medical Products Bill” (19 August 2025) Cabinet Paper at [26]. https://www.health.govt.nz/information-releases/ supporting-innovation-through-the-medical-productsbill 12. For example, the International Medical Device Regulators Forum defines SaMD as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” See: International Medical Device Regulators Forum “Software As a Medical Device (SaMD): Key Definitions” (18 December 2013)

Bell Gully

IMDRF https://www.imdrf.org/sites/default/files/docs/ imdrf/final/technical/imdrf-tech-131209-samd-keydefinitions-140901.pdf at [5.1].

13. Ministry of Health and Cabinet Social Outcomes Committee “Modernising regulation of medicines and medical devices” (11 October 2024) Cabinet Paper https://www.health.govt.nz/information-releases/ cabinet-material-modernising-the-regulation-ofmedicines-and-medical-devices 14. At [25].

15. At [37].

16. Ministry of Health and Cabinet Social Outcomes Committee “Supporting innovation through the Medical Products Bill” (19 August 2025) Cabinet Paper at [24]. https://www.health.govt.nz/information-releases/ supporting-innovation-through-the-medical-productsbill 17. Ministry of Health “Supporting innovation through the Medical Products Bill” (19 August 2025) Briefing for decision at [31]. https://www.health.govt.nz/ information-releases/supporting-innovation-throughthe-medical-products-bill 18. Ministry of Health and Cabinet Social Outcomes Committee “Modernising regulation of medicines and medical devices” (11 October 2024) Cabinet Paper at

The Big Picture Health

[36] https://www.health.govt.nz/information-releases/ cabinet-material-modernising-the-regulation-ofmedicines-and-medical-devices 19. Medicines Act 1981, s 55F. 20. Ministry of Health and Cabinet Social Outcomes Committee “Medical Products Bill: reducing regulation and other policy matters” (13 October 2025) Cabinet Paper at [6]. https://www.health.govt.nz/system/ files/2025-10/Cabinet-paper-Medical-Products-Bill.pdf 21. Ministry of Health and Cabinet Social Outcomes Committee “Supporting innovation through the Medical Products Bill” (19 August 2025) Cabinet Paper at [15]. https://www.health.govt.nz/information-releases/ supporting-innovation-through-the-medical-productsbill 22. Ministry for Health and Cabinet Social Outcomes Committee “Modernising regulation of medicines and medical devices: high-level regulator settings” Cabinet Paper at [27]. https://www.health.govt.nz/informationreleases/cabinet-material-medical-products-billreducing-regulation-and-other-policy-matters 23. Health New Zealand Te Whatu Ora “Updated Health Delivery Plan” (media release, 17 July 2025) https:// www.tewhatuora.govt.nz/corporate-information/newsand-updates/updated-health-delivery-plan

25

Level 14 Deloitte Centre 1 Queen Street Auckland 1010

Level 4 Bell Gully Building 40 Lady Elizabeth Lane Wellington 6011

Phone: +64 9 916 8800 Fax: +64 9 916 8801

Phone: +64 4 915 6800 Fax: +64 9 916 8801

bellgully.com

The Big Picture: Health