Since forming the current Government, the coalition has been clear about its intention to repeal the Therapeutic Products Act 2023 (TPA). The big question has always been: what will replace the TPA? Recently, a Cabinet paper has been released that goes some way to answering that question. The TPA is proposed to be replaced by a new Medical Products Bill (Bill). The Cabinet paper indicates that, consistent with industry and consumer feedback on the TPA, the new Bill will focus on risk-proportionate regulation, international harmonisation, providing access to safe and affordable medical products, and supporting innovation.
There are clear similarities between parts of the TPA and the proposed Bill. While the TPA was a framework Act with specific regulatory detail to be included in rules and regulations (such as pathway approvals for medicines and medical devices), it appears that a greater level of detail will be included in the Bill. There are also some clear differences between the two regimes.
In this article, we summarise the key regulatory approach proposed for medicines, medical devices, and natural health products.
Medicines
Medicines will continue to require regulatory approval before being supplied and administered (subject to exceptions), and manufacturing and other activities will still require licensing. However, under the proposed Bill, an abbreviated assessment pathway will be available if a medicine has been approved by a trusted overseas regulator. A similar change may occur prior to the proposed Bill becoming law, as the Government is proposing to amend the existing medicines approval pathways so that Medsafe will be able to approve, within a short timeframe, medicines that have been approved by at least two recognised overseas medicines regulatory authorities.
Like the TPA, the proposed Bill will clarify the rights to use unapproved medicines and there will be pathways for professions to gain or expand prescribing rights and other powers in relation to medicines by modifying scopes of practice. But, all in all, the Cabinet paper highlights that the proposed Bill should not represent a major change to the activities of health professionals or businesses operating under current medicines licenses.
Medical devices
In respect of medical device regulation, there are key differences between the TPA and the new Bill. The Cabinet paper emphasises the need for a risk-proportionate regulatory system, and one that aligns with international systems "wherever possible". The Bill will provide for various approval pathways:
- Low-risk medical devices may require only a declaration of compliance with applicable standards by the sponsor
- Medium- and high-risk devices may be approved if they already have the approval of 'trusted overseas regulators', or will otherwise be assessed based on the nature and risk profile of the device
- Bespoke pathways may be made available for innovative or locally manufactured devices.
Unlike the TPA, export-only medical devices will not require approval within New Zealand.
During the development of the TPA, the medical device industry raised concerns about the impact of the new approval requirements for medical devices, which are typically imported from overseas and often have approval by other regulators (such as the FDA). While those concerns may have been addressed through rules and regulations under the TPA, having specific approval pathways set out in the Bill will alleviate some uncertainty for the medical device industry and stakeholders.
We expect that, under the proposed Bill, the definition of 'medical device' will be narrower than under the TPA. The Ministry of Health has advised that software used in a medical setting (such as a patient booking system) will not be regulated under the proposed Bill. Decisions have yet to be made as to whether sunscreen and software as a medical device (including artificial intelligence) should be regulated.
Other products
- Whereas the TPA proposed regulating whole organs used for therapeutic purposes as medical devices, the proposed Bill will include provisions that are specifically tailored to reflect the special characteristics of human blood, tissues and organs. The Bill may also explicitly exempt some of those products from the product approval requirements
- Biologics and advance gene therapies will be regulated, although to accommodate advances in manufacturing processes and medical technologies, the Bill is likely to include flexible provisions that enable the approval of processes rather than products.
Natural health products
As expected, it is proposed that most natural health products will be regulated under separate new legislation, which will be developed through engagement with the natural health products sector over the coming year. However, natural health products with vitamins and minerals above a certain level will be regulated under the Bill, consistent with international regulation.
Next steps
The Cabinet paper makes clear that important work remains to be done on key policy aspects of the new Bill including (among other matters) advertising, post-market controls, regulation of pharmacies, software as a medical device (including artificial intelligence), and offences and penalties. The paper indicates that further Cabinet approvals will be sought in March 2025 on those issues. We expect a draft Bill to be introduced in late 2025 as the Government has indicated it intends to have the Bill enacted during this parliamentary term.
Buddle Findlay will be closely following developments in this space. If you have any questions, please contact one of our health team.
