In a recent and notable development, the New Zealand government has repealed the Therapeutic Products Act 2023. This Act, which received Royal Assent on July 26, 2023, was originally intended to transform the regulatory framework for medical devices, medicines and natural health products in New Zealand. However, its repeal means a return to the older regulatory structures primarily governed by the Medicines Act 1981.
The Therapeutic Products Act 2023 had been a major point of discussion in the medical device industry, promising to bring about significant changes in the way healthcare products are managed from production to sale. With its repeal, the industry now finds itself operating within the familiar parameters of existing legislation. While this situation provides a degree of stability, it also raises questions about the need to modernize the decades-old regulations currently in place.
It’s important for industry stakeholders to pay close attention to how the government plans to address future regulatory requirements. While the Therapeutic Products Act 2023 was seen as a step toward modernization, its repeal leaves the timing and nature of future regulatory changes uncertain.
With this in mind, let’s take a closer look at what the Therapeutic Products Act 2023 was intended to achieve. While these regulations will no longer be implemented, understanding them provides insight into the potential direction of future legislation.
Why the New Legislation was Needed
Historically, New Zealand’s approach to the market entry of medical devices can best be described as lenient. The primary mechanism is the registration of these products on the central WAND database by Medsafe. Individuals wishing to enter medical products into this database simply need to register as a sponsor. However, there is a glaring absence of rigorous professional qualifications for these sponsors; being a resident of New Zealand is the only requirement. Apart from labelling and advertising directives, the system is characterised by a conspicuous absence of in-depth scrutiny, resulting in a regulatory environment that lacks comprehensive market surveillance.
This minimalistic approach raises several concerns:
- Lack of Oversight: Without proper controls in place, the potential for sub-standard or unsafe products entering the market is ever-present.
- Absence of Global Alignment: As international healthcare standards advance, New Zealand’s existing system lags, potentially risking the nation’s reputation and the safety of its citizens.
- Limited Regulation of Innovative Therapies: Groundbreaking areas like cell, gene, and tissue therapies remain in a regulatory blind spot, despite their potential impact on healthcare.
- Unregulated Natural Health Products: With a growing global emphasis on natural health and wellness, the lack of clear regulation for these products in New Zealand is a glaring gap.
Given these challenges, and as health technologies continue to evolve at a rapid pace, there continues to be a strong demand for change. The nation needs a framework that is not only robust and comprehensive but also agile enough to adapt to the rapidly shifting sands of healthcare innovation. The Therapeutic Products Act 2023 was New Zealand’s answer to these pressing demands, promising a future where safety, innovation and international harmonisation came together. However, this Act was subsequently repealed.
The Provisions of the Therapeutic Products Act for Medical Devices
The Therapeutic Products Act 2023 not only aimed to provide a comprehensive framework for the overall therapeutic products landscape in New Zealand, but specifically introduced a number of significant changes for medical devices. The Therapeutic Products Act 2023 combined the dual objectives of safeguarding public health and promoting industry growth and innovation.
Let’s take a closer look at how the Act would have affected the medical device sector, looking at the key objectives and major changes to the regulatory environment.
Key Goals of the Act for Medical Devices
At its core, the Therapeutic Products Act 2023 was committed to:
- Ensuring Safety and Quality: By implementing stricter controls, the Act endeavored to ensure that every medical device available to New Zealanders adhered to high standards of safety and performance.
- Promoting Innovation: While safety was paramount, the Act was designed to be flexible enough to support and foster innovation within the medical device industry.
- Aligning with Global Standards: Recognizing the importance of international harmony, the Act was designed to be in sync with global medical device regulatory standards.
- Filling Regulatory Gaps: Given that medical devices and certain advanced therapies were not fully regulated in New Zealand, this Act sought to address and rectify this oversight.
Pivotal Changes for Medical Devices
The Act introduced several transformative changes for medical devices:
- Market Authorisation Process: The current regime allows devices to be registered after being in New Zealand for up to 30 days. The new Act mandated that devices could not enter the market without prior authorization, signaling a more proactive regulatory stance.
- Clear Distinction between Manufacturers: One of the novel introductions of the Act was the differentiation between the manufacturer and the responsible manufacturer, with added clarity for those utilizing device production systems or involved in remanufacturing devices.
- Heightened Qualification Standards: With an intent to maintain impeccable standards throughout the device lifecycle, the Act stipulated enhanced qualification, training, and competency requirements for everyone in the supply chain.
- Revised Sponsorship Regulations: Sponsors play a pivotal role in the medical device ecosystem, and the Act introduced a dedicated subsection outlining their duties, obligations, and provisions.
- Reclassification of Modified Devices: In a move to ensure that significant modifications to devices underwent rigorous scrutiny, any major change to an approved device necessitated a fresh approval, essentially categorizing it as a new product.
Implications for Medical Device Manufacturers
In the wake of the Therapeutic Products Act 2023, medical device manufacturers found themselves navigating a transformed regulatory landscape. The new terrain was marked with challenges but also laden with opportunities. Here’s a breakdown of what the future may have held for these manufacturers:
Product Purpose Clarification for New Zealand Market
Manufacturers, especially those with products previously exclusive to the New Zealand market, needed to ensure they correctly and thoroughly defined the intended purpose of their products. This definition determined the classification and market authorization process for the product.
Implication: A clear and accurate understanding and description of a product’s purpose were vital for the appropriate regulatory process.
Enhanced Scrutiny and Accountability
With the introduction of the Market Authorisation Process and increased qualification standards, manufacturers needed to be even more diligent. Each device was subject to rigorous scrutiny before it entered the market, and manufacturers were held more accountable for the safety, quality, and efficacy of their products.
Implication: Manufacturers likely needed to invest more in research, quality assurance, and compliance processes to ensure their products met the enhanced regulatory standards.
Clearer Definitions and Responsibilities
The Act’s clear distinction between a manufacturer and the responsible manufacturer, as well as definitions related to device modifications, provided manufacturers with a clearer understanding of their roles and responsibilities.
Implication: This clarity could streamline internal processes but also demanded a heightened sense of responsibility, especially for those involved in remanufacturing or making significant modifications to existing devices.
Opportunity for Innovation
While the Act introduced stricter regulations, its flexibility in encouraging innovation was a silver lining. Manufacturers were incentivized to explore new frontiers in medical device technology, knowing that there was a supportive framework that valued innovation.
Implication: Companies that prioritized research and development may have found themselves at a competitive advantage, given the Act’s emphasis on supporting innovative solutions.
Global Alignment and Market Expansion
Aligning with international standards opened doors for New Zealand’s medical device manufacturers to expand their reach. With products that adhered to global standards, the potential for international market penetration increased.
Implication: Manufacturers could look to global markets with greater confidence, but this also meant they needed to keep abreast of international regulatory changes to maintain this alignment.
Training and Development Focus
Given the Act’s emphasis on qualifications, training, and competence throughout the supply chain, manufacturers needed to prioritize the ongoing professional development of their teams.
Implication: This led to initial investments in training programs and workshops, resulting in a workforce that was more skilled and adept at navigating the nuances of medical device manufacturing and distribution.
Engaging with Sponsors
The revised regulations around sponsorship meant that overseas manufacturers had to foster close collaborations with sponsors, ensuring they were aligned in their understanding and adherence to the Act’s provisions.
Implication: This required manufacturers to revisit and possibly renegotiate agreements with sponsors to ensure compliance with the new regulatory framework.
Conclusion: The Road Ahead for Medical Device Regulation in New Zealand
The Therapeutic Products Act 2023 marked a significant milestone in New Zealand’s healthcare regulatory environment. For medical device manufacturers, this legislation was a clear indicator of the direction in which industry standards were heading: higher benchmarks, but with an acknowledgment of the importance of innovation and global synchronicity. Those manufacturers who were proactive and prioritized quality, innovation and training were better positioned to respond to this evolving landscape.
With the repeal of the Therapeutic Products Act 2023, New Zealand’s healthcare regulatory landscape faces a new chapter. This turn invites speculation and anticipation about the future direction of healthcare regulation. What will replace the Act, and how will it address the evolving needs of the healthcare sector and international standards? During this period of transition, it’s crucial for stakeholders, especially medical device manufacturers, to stay alert to changes and prepare for the new regulatory framework that will emerge. We will continue to monitor and report on these developments, offering guidance and insights into the evolving landscape of healthcare regulation in New Zealand.
If you have any questions about the Therapeutic Products Act (2023), please don’t hesitate to contact Johner Institute New Zealand. We are here to help.
