The Therapeutic Products Bill, promising to revolutionize the regulatory landscape for therapeutic goods in New Zealand, has stirred intense discussions among experts and industry insiders. A recent event that vividly encapsulated this discourse was the New Zealand HealthTech Week, where the director of the Johner Institute New Zealand, Anne Arndt, was invited to give her insights on the topic during a panel discussion. Anne, along with other panelists, agreed on the necessity for change in order to better accommodate the rapid progress of medical technology.
The Bill, introduced to Parliament in November 2022, aims to replace the existing Medicines Act 1981, a piece of legislation ill-equipped to cope with the demands of novel technologies and a dynamic healthcare landscape. The proposed bill would also take over the Dietary Supplements Regulations 1985, thereby shaping the manufacturing, testing, import, promotion, supply, and export of medicines, devices, and natural health products in New Zealand.
Debates concerning the regulatory framework for medical devices in New Zealand have been ongoing since 2015. These discussions have only grown more urgent and complex in light of the COVID-19 pandemic. The pressing demand for quicker access to therapeutic goods, balanced with the absolute necessity of product safety, underscores the importance of the newly proposed bill as a critical advancement.
The Need for a Harmonized Regulatory Approach
The prevailing sentiment among industry experts is that a new regulatory framework is necessary to accommodate recent technological advancements. The existing regulation, dating back to 1981, lacks the provisions required to address the current challenges and complexities surrounding medical devices and Software as a Medical Device (SaMD).
The proposed solution is to adopt a regulatory system that aligns with other international standards. This harmonization could facilitate overseas certificate recognition, and potentially only require regulator evaluation for higher-classified products. It’s important to note that building knowledge at the regulatory level is critical, with a focus on technologies that could streamline testing and monitoring processes.
To foster innovation within the country, the proposal suggests a specialized authorization pathway. Also, existing registered products should be given protection. However, these are preliminary views, and the final regulation is yet to be revealed, as well as the guidance documents and guidelines.
A Closer Look at the Therapeutic Products Bill
The Therapeutic Products Bill, presently under consideration, aims to reshape the health sector’s regulatory landscape in New Zealand. It includes a multi-tiered system of an Act, Regulations, and subsidiary instruments, each with unique roles in this framework. The Act provides a clear structure and purpose, while the Regulations stipulate technical specifications, fee structures, and rule-making guidelines. The subsidiary rules and instruments offer detailed criteria, product norms, licensing terms, approval routes, and recognised authorities.
This proposed bill will critically distinguish between Software as a Medical Device (SaMD) and Software in a Medical Device, aligning with international norms. However, concerns have been raised about potential high costs and divergence from international harmonization, which may obstruct access to therapeutic products in New Zealand.
The Road Ahead
The Therapeutic Products Bill passed its second reading on 29th June following the release of the Health Select Committee report on June 13th. As this progress continues, the potential for far-reaching effects on medical device manufacturers and the healthcare industry at large remains significant.