The Medicines Act 1981 is well over 40 years old. Inevitably, since it was introduced there have been a huge number of advances in medical science and technology. By way of example, the Act came into force approximately nine years before Kiwis first gained access to the internet.
For decades, there has been talk of replacing the Act with more up-to-date legislation, but previous reform proposals never reached the finish line.
Last year, however, significant legislative reforms did make it across the line, in the form of the Therapeutic Products Act 2023 (TPA). The TPA, which was to supersede the Medicines Act and the Dietary Supplement Regulations 1985, received Royal Assent on 26 July 2023 and is currently in force (although many of its provisions will only become effective in 2026).
However, despite achieving Royal Assent, the future of the TPA now looks doubtful. This article briefly explores the controversies surrounding the TPA, analyses the coalition government's signalled intention to repeal it, and considers the likely future direction of New Zealand's therapeutic products regulation.
Controversial reforms
The TPA was said to be a result of more than a decade of policy work [1]. It was intended to modernise the regulatory regime for therapeutic products in New Zealand by, among other things, expanding the regime to govern a range of additional products, including Natural Health Products (NHPs) and medical devices (such as surgical mesh).
The TPA was always controversial. During the third reading of the Therapeutic Products Bill, members of the then-opposition called it "an overreach of bureaucracy", a "regulatory overburden", and alleged it would diminish the competitiveness of New Zealand's therapeutic product exporters [2].
It is therefore unsurprising that the new coalition government has signalled an intention to quickly repeal the TPA.
The coalition agreements
Both the National and ACT, and the National and New Zealand First coalition agreements include a promise to "repeal the Therapeutic Products Act 2023". Other relevant points in the agreements include:
- updating Pharmac’s decision-making model to ensure it appropriately takes "patient’s voice" into account (both agreements);
- requiring Medsafe to approve new pharmaceuticals within 30 days of them being approved by at least two overseas regulatory agencies recognised by New Zealand (both agreements);
- requiring the Ministry of Health to publish a Medicines Strategy every three years (National and ACT agreement); and
- allowing appropriately qualified pharmacists to directly prescribe certain treatments (National and ACT agreement).
Looking forward
Despite the wording of the coalition agreements, it is important to note that the TPA is still the law (although, as noted above, the majority of its provisions are not yet operative). The TPA will only cease to be law once it is formally repealed via the Parliamentary process.
Based on the wording of the coalition agreements, we think it is likely that the TPA will be repealed in 2024, and as a result:
- NHPs will once again be excluded from any consolidated therapeutic product regulation. (For the time being, it is likely that NHPs will simply remain subject to the Dietary Supplements Regulations 1985 (which itself is secondary legislation prepared under the Food Act 1981). We note that the purported over-regulation of NHPs was a major campaign point for New Zealand First. Suppliers of NHPs will continue to need to avoid ascribing a therapeutic purpose to such products to avoid them being regulated as "medicines" under the Medicines Act.)
- Similarly, medical devices will not be subject to any consolidated therapeutic products regulation. (For now, they will remain subject to the much simpler requirements of the Medicines (Database of Medical Devices) Regulations 2003.)
- MedSafe will not be replaced by the "Therapeutic Products Act Regulator" but will probably be required to approve medicines at a quicker rate. The process for achieving these faster approval times is currently unspecified.
- The much-anticipated Therapeutic Product Regulations will not go ahead.
- Any successor legislation to, or amendments to, the Medicines Act 1981 will not include any references to the principles of the Treaty of Waitangi. The National and New Zealand First coalition agreement makes it clear that they intend to "replace all [references to the Principles of the Treaty of Waitangi] with specific words relating to the relevance and application of the Treaty, or repeal the references". Such approach represents a significant departure from that of the previous government who, in the early stages of the TPA, noted that the "Te Tiriti o Waitangi principles are woven throughout [the Bill]" [2].
Opportunities?
Based on the wording of the coalition agreements, it seems unlikely that the therapeutic products regulatory landscape will be subject to any significant reforms for at least the next three years.
As a result, manufacturers and suppliers of therapeutic products are likely to benefit from the relative certainty of the status quo for a while longer. Businesses would be wise to use this relatively settled time to pursue areas of growth and expansion.
If you are a manufacturer or supplier of therapeutic goods and would like to know more about any of the issues addressed above and how they might impact your business, or if you need help with protecting or commercialising your IP rights, the AJ Park team is ready to assist.
[1] Beehive Press Release dated 30 November 2022.
[2] The Hon. Matt Doocey, 18 July 2023 Hansard (third reading).
[3] Former Health Minister the Hon. Andrew Little, 13 December 2022 Hansard (first reading).
