New Act brings faster medicines approvals: A dose of new rules

New Zealand is giving its medicine approval process a helpful boost. Last week's passage of the Medicines Amendment Act (Act) promises faster access to treatments through international recognition pathways, yet concerns linger about political influence creeping into what should be purely medical decisions. In this article, our experts outline what's changing, our thoughts, and why it matters for healthcare in New Zealand.

This milestone confirms the government’s commitment to improving access to safe, effective medicines for New Zealanders. As a quick recap, the Act’s main purpose is to help more New Zealanders access the medicines they need.

The key components of the Bill include:

  • enabling the Rule of Two, which allows medicines to be approved for distribution in New Zealand where they’ve been approved by two other recognised overseas jurisdictions. Initially, Australia, the United States, Canada, the United Kingdom, the European Union, Singapore and Switzerland will be recognised, however the Act provides the ability to add or remove recognised regulatory authorities by way of notice in the Gazette. This will reduce the time it takes to get medicines approved in NZ; and
  • • extending prescribing permissions under section 29 to other healthcare professionals such as nurse practitioners and pharmacist prescribers. This recognises the high clinical skill levels of these professionals and enables medicines to more effectively get to patients.

For a deeper dive into what the Act entails, see our earlier article here.

Last minute amendment

As anticipated, the government introduced into the Act a new exception that allows the advertising of unapproved medicines at medical conferences.[1]

To rely on this exception, the conference organiser must notify the Director-General of Health at least 30 working days prior to the conference’s opening. The notification must include:

  • confirmation that one or more unapproved medicines will be advertised;
  • the conference’s opening and closing dates;
  • where the conference will be held;
  • whether the medicines have been approved by a recognised overseas regulator; and
  • whether applications for approval in New Zealand have been submitted.

This last minute change opens the door for medical conferences in New Zealand to share insights on innovative, unapproved medicines – an opportunity previously limited to international events. This change is designed to help healthcare professionals access emerging treatment information locally, enhancing awareness and supporting timely patient access to promising therapies.

Our thoughts

The passage of the Act, even with its last-minute amendments, has sparked some debate. There have been concerns over the limited consultation to the late changes and the new approach of ministerial appointments for the Medical Classification Committee. Concerns were raised that this shift could introduce risks of politicisation and increased lobbying influence in critical health decisions.

That being said, these amendments represent a significant step forward in aligning New Zealand with international best practice. While Pharmac funding remains a critical piece of the puzzle, this legislative change ensures we are not standing still. By streamlining approval processes and reducing compliance costs for manufacturers, we are creating a more efficient and responsive regulatory environment. This proactive approach means that when funding decisions evolve, New Zealand will be ready to act quickly.

Next steps

With the Act now in force, we await the introduction of secondary legislation that will outline the detailed requirements for the new verification pathway. We will continue to monitor progress and provide updates as implementation unfolds.

Special thanks to James Burnett and Cody Makaki for assistance in writing this article. 

 

[1] “Medical conference” refers to any conference, including trade shows, where the intended audience are health practitioners regulated under the Health Practitioners Competence Assurance Act 2003.

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