After many years in development, the Therapeutic Products Act 2023 (the TPA) was passed in July last year. The intention was to provide a new framework for the regulation of products including medicines, medical devices and natural health products in a way that is comprehensive and balances the risks and benefits of the products.1 Medical devices in particular would go from being largely unregulated to being subject to a market authorisation regime similar to that for medicines. While the TPA may not have come into force until late 2026, it would have heralded a significant shift for the sector.
The new Government has now indicated that the TPA will be repealed. “Begin work to repeal the Therapeutics Products Act 2023” was included at number 47 out of 49 points on the Government’s plan for its first 100 days.2 We therefore expect moves to repeal the TPA relatively quickly.
Business as usual
That means that the existing legislative regime will continue to apply for therapeutic products. For medicines and medical devices, this is principally contained in the Medicines Act 1981 and its associated regulations, which include provisions for:
- the consenting of new medicines before sale/supply (in practice, this is done via a Medsafe approval process);
- registration (but no pre-market assessment) of medical devices via an online database;
- reporting of “untoward events” in relation to medicines (but no formal requirements for medical devices).
For natural health products, some regulation is provided by the Dietary Supplements Regulations 1985.
Rationale for reform remains
The Medicines Act has been criticised for a long time, with major attempts at reform commencing in the 2000s.3
In particular, concerns have been raised that the legislation (which is now over 40 years old) is outdated and difficult to follow.4 There are apparent gaps in the regime, particularly as it applies to medical devices, which may leave New Zealand out of step with comparable jurisdictions around the world. The existing provisions are also considered relatively inflexible.5
These concerns are likely to remain. Moreover, as medical technology advances, there is a real risk that gaps in the existing regime become more apparent, creating difficulties in applying regulation to new products which may warrant controls.
What comes next?
Given that the reasons for reform are still there, and indeed may become more acute, there is a question as to what comes next.
The Government has yet to signal its intended approach for therapeutic products more broadly. However, both the National-Act and National-New Zealand First Coalition Agreements include provision 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.”6
At present, there are no requirements as to timeframes in the Medicines Act – indeed, the only reference to a medicine’s approval process is section 20’s requirement that new medicines obtain consent from the relevant Minister before they are sold, distributed or advertised. However, Medsafe’s website indicates that it currently targets 100 days for its initial review of intermediate and high-risk new medicines under its abbreviated pathway, which is the pathway used for products which already have at least one overseas approval.7 There is also no guarantee that medicines approved overseas will be approved here, even if Medsafe will consider those overseas approvals.
If the Medicines Act is to be amended to implement that timeframe (as seems to be the most likely option), there will be a question as to what else the Government may seek to amend at the same time.
However, it seems that wholesale reform in the short term is unlikely. The TPA took almost ten years to be developed and passed – any attempt to restart that process from scratch will likely take significant time. However, with the rationale for reform still present, and the current legislation only becoming more outdated, there is a question as to whether the Medicines Act will still be around to mark its half century.
If you have any questions about the matters raised in this article, please get in touch with the contacts listed or your usual Bell Gully adviser.
 Therapeutic Products Bill, Government Bill 204-2, as reported from the Health Committee, “About the bill as introduced” (Therapeutic Products Bill 204-2 (2022), Government Bill – New Zealand Legislation). You can read our previous articles discussing the Therapeutic Products Bill here and here. Our Big Picture: Health, which also discussed proposals for therapeutic products reform, is available here. Coalition government 100-day plan at 47 (100_Day_Plan.pdf (nationbuilder.com). Ministry of Health (2018), “Therapeutic Products Regulatory Scheme Consultation Document” (Therapeutic Products Regulatory Scheme: Consultation document (health.govt.nz)). Office of the Minister of Health, “Medicines Amendment Bill: Approval for Introduction” at 3 (medicines_amendment_bill_approval_for_introduction.pdf (health.govt.nz)); Medicines Amendment Bill — Second Reading - New Zealand Parliament (www.parliament.nz). Ministry of Health, above n 4. Coalition Agreement of the 54th Parliament, “New Zealand National Party & New Zealand First”, at 8 (Coalition Agreement - New Zealand First (nzfirst.nz)). Medsafe, “Target Evaluation Times for NMAs and CMNS” (Evaluation Timeframes and Registration Situation (medsafe.govt.nz).