Explainer | How New Zealand’s Proposed Medical Products Bill Aims to Reshape Health Regulation
- Amelie Lim
- 12 minutes ago
- 4 min read
Written by Amelie Lim
New Zealand sits on the verge of significant reform to its healthcare regulatory framework. Present legislation no longer manages the demands of contemporary medicine. In response to this growing issue, the Government has proposed the Medical Products Bill. The planned overhaul aims to modernise regulatory structures (Shrive, Go, & Adams, 2019; “Modern Medicine Laws Coming Soon to New Zealand,” 2024), and the proposed Bill articulates an approach that prioritises risk proportionate regulation, patient safety, innovation, and support for future industry development (Costello, 2025).
A Predecessor in Need of Reform
Parliament has recognised that modern healthcare requires more agile, risk-based legislation.
The Medicines Act 1981, which has governed the health sector for over four decades, has been increasingly regarded as insufficient to address rapid advancements in medicines, advanced therapies, and medical devices (“Regulating Medicines, Medical Devices and Natural Health Products | Ministry of Health NZ,” 2025).
Moreover, the Therapeutic Products Act (TPA) aimed to consolidate the regulation of medicines, medical devices, and natural health products under a single legislative framework. Although ambitious, it drew criticism for its rigidity and overregulation of low-risk natural health products. Following extensive public consultation, including over 200 submissions to the Health Committee, it became clear that neither the TPA nor the Medicines Act 1981 met the needs of stakeholders or the public (“Medicines Amendment Bill – Health Committee Calls for Submissions,” 2025).
Currently, advertising unapproved medicines is illegal, a rule designed to protect consumers from unsafe or ineffective treatments. However, this restriction has sometimes produced unintended consequences, such as penalising families raising funds for overseas treatments (Costello, 2025). The new Bill seeks to balance consumer protection with common sense flexibility, allowing for limited promotion of unapproved products under controlled circumstances, such as medical conferences or public health emergencies (Costello, 2025; “Documents on the Medical Products Bill,” 2025).
Overview of Objectives of the Proposed Bill
On 18 August 2025, Cabinet agreed on a series of key policy matters underpinning the Medical Products Bill (“Documents on the Medical Products Bill,” 2025):
Regulation of pharmacies, including pharmacy ownership and the introduction of a supervisory pharmacist role.
Modernisation of advertising rules for medicines and medical devices.
Statutory timeframes and compliance measures.
Support for medical product exporters.
Clearly defining offences and penalties.
Strengthening the oversight of Medsafe as the regulatory authority.
What Specific Changes will the Bill Introduce?
A central innovation of the Bill is the removal of the requirement for pharmacies to be majority-owned by registered pharmacists. This change allows companies and individuals to explore alternative ownership structures while maintaining rigorous professional standards (Costello, 2025). Pharmacists will be able to focus on delivering high-quality patient care, while the supervisory pharmacist role ensures compliance across companies operating multiple pharmacies.
Furthermore, the Bill seeks to clarify the regulation of advertising. A more precise definition of advertising will make it easier for manufacturers, health practitioners, and the public to understand what is and is not considered promotional material. Activities such as fundraising, news reporting, and education will not be classified as advertising. Direct-to-consumer advertising of prescription medicines will continue, with regulatory safeguards where necessary. These changes aim to improve public access to accurate information while protecting consumer safety (“Regulating Medicines, Medical Devices and Natural Health Products | Ministry of Health NZ,” 2025).
The Bill introduces differentiated approval pathways based on the nature and risk profile of products. Low-risk devices, such as surgical masks, may undergo minimal regulation through self-declaration, whereas high-risk products will undergo a more rigorous assessment. Products already approved by trusted overseas regulators can benefit from abbreviated approval pathways, aligning New Zealand’s regulatory framework with international best practices. Innovative products can also be assessed over time without requiring legislative amendments, and certain high-risk categories, such as AI-driven devices and human or non-human tissues, can be managed via secondary legislation. Export-only products will not require full approval, but support mechanisms for exporters will remain in place (Shrive, Go, & Adams, 2019; “Modern Medicine Laws Coming Soon to New Zealand,” 2024).
Future Steps
Drafting of the Medical Products Bill is underway, with most recent policy proposals updated on 14th October 2025 (Costello, 2025). Key topics include:
Regulation of clinical trials
Pharmacy oversight and supervisory structures.
Support for medical product exporters.
Advertising regulation.
Oversight of software-based medical devices, including AI.Development of a separate regulatory framework for natural health products.
The Government anticipates passing the Medical Products Bill by 2026, with implementation around 2028, including a transition period to integrate existing products into the new regulatory framework (“Modern Medicine Laws Coming Soon to New Zealand,” 2024).
Conclusion
New Zealand’s proposed Medical Products Bill promises to reshape the healthcare landscape, fostering innovation, safeguarding public health, and improving access to medicines and medical devices. By combining flexibility, evidence-based regulation, and stakeholder engagement, the Government is aiming to deliver a dynamic, patient-centred system that is highly efficient. These reforms mark a transformative moment in health regulation, ensuring that New Zealanders benefit from safer, more effective, and more accessible medical products in the years to come.
References
Costello, Casey. “Medical Products Bill Taking Shape.” Govt.nz, 2025,
“Medicines Amendment Bill – Health Committee Calls for Submissions.” Dentons.co.nz, 2025,
“Modern Medicine Laws Coming Soon to New Zealand.” Dentons.co.nz, 2024,
“Regulating Medicines, Medical Devices and Natural Health Products | Ministry of Health NZ.”
Ministry of Health NZ, 13 Apr. 2025,
Shrive, Craig, et al. “Prescription for Change: New Medical Products Bill Expected.”
Russellmcveagh.com, 2019,
“Documents on the Medical Products Bill.” Govt.nz, 2025,
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