Tuesday, June 18, 2024

New Zealand to Repeal Therapeutic Products Act 2023 for Better Regulatory Framework

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The New Zealand Associate Minister of Health, Casey Costello, has announced the government’s intention to repeal the Therapeutic Products Act 2023 (TPA) to establish a more effective regime for providing safe and timely access to medicines, medical devices, and health products.

Developed over nearly a decade, the TPA aimed to create a new regulatory agency and overhaul New Zealand’s regulatory framework for medical devices. However, Ms. Costello emphasized that while the current Medicines Act is outdated, the Therapeutic Products Act was not the appropriate solution. “The TPA would have over-regulated some products and imposed unnecessary costs on consumers, businesses, and exporters,” she explained.

Industry groups had raised concerns that the Therapeutic Products Act would over-regulate lower-risk products, such as some natural health products, making them more expensive or unavailable. Additionally, consumers, importers, and practitioners worried that the Act would not improve approval times for new medicines.

Coalition Government Repeals Therapeutic Products Act Over Regulatory Concerns and Costs

Repealing the Therapeutic Products Act has been a goal of the three-party coalition government since it defeated the incumbent Labour Party in November of last year. The repeal is seen as a response to widespread dissatisfaction with the current 43-year-old Medicines Act and its regulations, and criticism of the Therapeutic Products Act for increasing costs and overregulating low-risk health products.

In contrast to neighboring Australia, New Zealand has relatively loose regulations for medical devices, with minimal pre-market requirements beyond in-country representation and notification in the Web Assisted Notification of Devices (WAND) database. No evidence of conformity assessment is required for notification or market placement of medical devices, regardless of risk classification.

Therapeutic Products

New Zealand to Develop Modern Regulatory Regimes for Medicines and Health Products

Ms. Costello announced that the Government will now focus on developing a modern, risk-proportionate regulatory regime for medicines and medical devices, and a separate updated regime for natural health products. This new regime aims to support innovators and health practitioners, providing timely access to new and promising therapies, improving health outcomes, and reducing pressure on general practitioners and the hospital system.

The repeal Bill is intended to pass before the end of the year, ensuring no requirement for businesses or practitioners to change their current operations and no disruption to consumers. The Government will consider proposals for new legislation later this year to streamline the approval process for new medicines and support innovation in health and medical products, as well as economic growth. The repeal of the Therapeutic Products Act aligns with commitments in the National-New Zealand First and National-ACT coalition agreements. Key groups will be engaged throughout the legislative process to develop the best possible law and frameworks.

 

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Resource: New Zealand Government, May, 2024

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