From Ysabella Stevenson 

Overview of the TPA 

Enacted in July 2023, the Therapeutic Products Act 2023 (TPA) is an ambitious piece of legislation that was intended to develop, improve, and in some cases, introduce, regulatory standards for therapeutic products. The TPA covers a wide range of products, broadly categorised as medicines, medical devices, active pharmaceutical ingredients (APIs), and natural health products (NHPs). Driven by safety and quality, the TPA provides a high-level framework for market authorisations, controlled activities and supply chain activities involving therapeutic products. Part 9 establishes a Therapeutic Products Regulator, the new body intended to oversee the regime. The TPA conveys a host of powers to the Regulator, not only to authorise market entry, but to continuously survey products, monitor compliance, make regulatory orders, and apply penalties where necessary. The TPA was set to put New Zealand’s regime on par with comparable jurisdictions. Despite this potential, however, the new Government has sent the TPA to the chopping block – a repeal is pending. 

 Particular features  

The structure of the TPA reflects a trend toward the need for regulatory flexibility and continuous improvement. Current regimes rely too heavily on primary legislation. By placing all of the detail in an Act of Parliament, the provisions of the act are effectively set in stone. Parliament has a long waiting-list, and a range of hurdles to overcome before changes can be implemented. Delays are problematic in the context of therapeutic products, because outdated provisions place a burden on consumers. For example, the Ministry of Health has recognised that the Medicines Act 1981 is largely outdated, with significant gaps in coverage. The result is a regime that fails to adequately address the needs of modern consumers. Further, medical technology is constantly developing, and research is continuous. If government actors cannot adequately regulate the entry and use of new technologies, consumers may be exposed to increased risk of harm. The TPA addresses these concerns by establishing a high-level framework, shifting the detail into secondary legislation to be developed in future. Provisions are left sufficiently broad for the Regulator and its delegates to tailor secondary legislation to fit current market needs and standards. Any regulations can be changed with sufficient consultation from regulating bodies, and without the unnecessary ordeals of Parliament. 

 Perhaps the most significant feature of the TPA is the introduction of market authorisation. Pre-market approval is a novel development, particularly in the medical device and natural health product (NHP) spaces. Generally, a medicine, a medical device, or an NHP now cannot be imported, supplied, or exported without a market authorisation. The TPA establishes three types of market authorisation: standard, provisional, and export. Each authorisation has associated criteria that a product must meet, with (somewhat) less stringency imposed on products put forward for provisional and export authorisations. By imposing a stronger barrier to entry, the TPA acknowledges deficiencies in the current approach. A degree of stringency is required to ensure the safety and quality of therapeutic products entering the New Zealand market. 

Reasons for its implementation  

The TPA was implemented as a long-awaited remedy to inadequacies in existing regulatory schemes. Medicines are subject to an extensive array of requirements under the Medicines Act. However, the current approach to medical device regulation is  “piecemeal”, a “confusing array of instruments” that is “inflexible” and “dated”. Similarly, there is no comprehensive regime regarding NHPs. NHP consumers rely on the Fair Trading Act 1986, the Consumer Guarantees Act 1993, and the Dietary Supplements Regulations 1985 to ascertain product safety – an approach that the Ministry of Health recognises is “not fit for purpose”. 

What brought about the repeal  

The TPA was subject to significant controversy in its legislative journey. Firstly, the inclusion of NHPs was an important concern for rongoā practitioners. Rongoā is the traditional Māori healing system. The previous Government responded by expressly excluding rongoā from the scope of the TPA. Secondly, the National Party and the ACT Party were avidly against the TPA as a whole. The increased stringency in regulations was seen as an “overreach” that would place high compliance costs on small manufacturers and retailers. The ACT Party criticised the new export authorisation, noting exporters “expressed disappointment” at the lack of international harmonisation that is desirable to facilitate access to export markets. Both parties considered that innovation would be significantly hindered. The overall sentiment is captured in the ACT Party’s closing statement, that the TPA will “kneecap growth industries with a double-barrelled handicap of new regulatory hurdles and excessive compliance costs.” Notably, other comparable nations have similar levels of oversight to those proposed, which do not appear to “kneecap” them. In light of the parties’ views, it is no surprise that the new coalition Government has chosen to repeal the TPA.  

Effects of the repeal  

The repeal itself will bring no significant change, as most of the TPA’s provisions were not set to commence until mid-2026. Undoubtedly, the new Government has put any developments on pause, pending the official repeal. New Zealand’s regulations will remain at status quo. While the TPA was intended to repeal and amend a range of existing provisions, including most of the Medicines Act, these instruments will remain in force.  

Comparison with other nations 

In regulating medical devices, New Zealand lags behind other jurisdictions. The tables below show the pre-market approval processes required for medical devices to successfully get to market in Australia, the EU, and the US. 

Opinion on the repeal 

The TPA is an imperfect masterpiece. A close analysis reveals various potential sources of trouble. However, the high-level structure provides the appropriate starting point to develop a regime that is tailored to New Zealand’s needs. That is the beauty in flexibility – secondary legislation, developed through close consultation with the different industries, can ensure the end-product is fit for purpose. Barriers to market entry are certainly a relevant concern. As a small, isolated country, New Zealand must ensure overseas manufacturers are not deterred from entering the market, but the government must also ensure that New Zealand consumers are not put at unnecessary risk. Heightened compliance costs can create a significant change for small New Zealand companies, particularly in the medical device industry, where national regulations are currently non-existent. However, National and ACT appear to have jumped the gun. The TPA only imposes a structure for regulations moving forward. Harsh regulations are not inherent. The criteria that the TPA imposes is too broad to reach any definitive conclusions; it has the potential to be as strict or flexible as industries, and consumers, need it to be. Regardless, New Zealand is now back to the drawing board. We can only wait to see what happens next. 

Fig. 1 – Australia Regulations 

Fig. 2 – EU Regulations 

 Fig. 3 – US Regulations