Therapeutic medicines legislation to be axed
The Government is repealing the Therapeutics Product Act, which passed just last year, with associate Health Minister Casey Costello saying the legislation over-regulated products and would make them costly.
Instead, it intends to introduce a new regime for medicines and medical devices, and a separate one for natural health products. The repeal had been signalled by the coalition Government’s agreement last year.
Most provisions in the act were due to come into force in September 2026.
Consultation attracted more than 16,500 submissions, 95% of which opposed the bill, mostly due to the inclusion of natural health products.
The bill created points of contention around regulating rongoā (traditional Māori healing), and there were fears that it would constrain chronically ill people who were importing medicines.
The legislation was intended to modernise the way medicines, medical devices and health products were regulated, and replaced the Medicines Act and Dietary Supplements Regulations.
It regulated how New Zealanders were able to access advances in medicine like cell and tissue therapies, gene therapies, and the use of artificial intelligence and machine learning software, but also captured mainstream supplements like vitamins. It meant claims on natural health products had to be substantiated.
Costello said “a better regime” would be enacted “to provide New Zealanders safe and timely access to medicines, medical devices and health products”.
“The current Medicines Act is out of date, but the TPA was not the solution. It would have over-regulated some products and imposed unnecessary costs on consumers, businesses and exporters.”
Costello said industry and consumers were concerned that some low-risk natural health products would be over-regulated, making them more expensive or unavailable, “and I am not confident the act would have improved approval times for new medicines”.
She intended for the repeal bill to pass before the end of the year.
“The Government will now develop a modern, risk-proportionate regulatory regime for medicines and medical devices, and a separate modernised regime for natural health products,” Costello said.
“The new regime needs to back our innovators and health practitioners and to provide timely access to new and promising therapies.
“As well as improving peoples’ health, the right system will take the pressure off our general practitioners and our hospital system.”
The Government will consider proposals for new legislation later this year.
“There will be engagement with key groups through this process,” Costello said. “I hope we can build on some of the work that has already been done in this area, and look forward to hearing from consumers, industry and practitioners.”