The Associate Minister of Health, the Hon Casey Costello, has announced that the coalition Government will repeal the Therapeutic Products Act 2023 (the Act) by the end of the year. 

The Therapeutic Products Bill was passed in July 2023, with the Act scheduled to come into effect in September 2026, as we explained recently here. However, the new coalition Government announced the repeal of the Act in November 2023.

The repeal

The Associate Minister of Health highlighted that the Act aimed to enhance regulatory oversight but risked burdening the system, particularly low-risk medical devices and natural health products, with unnecessary red tape, potentially escalating costs and restricting access. 

As outlined in our previous article, the repeal of the Act means that the existing Medicines Act 1981 (Medicines Act) and regulations will continue to apply to medicines and medical devices and the Dietary Supplements Regulations 1985 (Dietary Supplements Regulations) will continue to set composition and labelling requirements for some natural health products. 

The path ahead - Proposed four-pronged approach

Although the Act has been canned, the Government has acknowledged that the current Medicines Act is outdated and intends to develop a lasting and robust solution that appropriately balances oversight and efficiency, aiming to better support New Zealand’s healthcare industry. 

The Associate Minister of Health proposes a four-pronged approach moving forward:

1. Repealing the Act by the end of 2024;
2. Implementing targeted improvements to the current Medicines Act and the Dietary Supplements Regulations. Some changes are already underway, such as changes to the access of cold and flu medicines with pseudoephedrine, and non-legislative changes to Pharmac’s approval process. We can expect more changes to be announced soon; 
3. Developing modern, risk-proportionate legislation for medicines and medical devices, aiming for enactment within the current parliamentary term; and
4. Creating a tailored, risk-proportionate approach for natural health products, emphasising the need for separate regulation for consumers and industry stakeholders. 

Next steps

Policy proposals for modern, risk-proportionate regulation for medicines and medical devices, including therapeutic uses of artificial intelligence and software as medical devices are expected by the end of November 2024. 

We will continue to monitor any developments and keep a close eye on the proposals we expect to see later this year. 

Get in touch

If you would like to discuss any aspect of this article, and what this might mean for you, please get in touch with one of our experts.

Special thanks to James B. Burnett and Priya Prakash for their assistance in writing this article.