Source: New Zealand Government
The Therapeutic Products Act (TPA) will be repealed this year so that a better regime can be put in place to provide New Zealanders safe and timely access to medicines, medical devices and health products, Associate Health Minister Casey Costello announced today.
“The medicines and products we are talking about are critical to New Zealanders’ health. We want cost-effective access to the right products, to support health outcomes, and to ensure there aren’t unnecessary barriers for our exporters,” Ms Costello says.
“The current Medicines Act is out of date, but the TPA was not the solution.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.
“In repealing the Act, the Government is listening to the concerns of industry and consumers.
“Industry groups considered their products would be over-regulated, particularly lower risk products, such as some natural health products. Consumers, importers and practitioners, told us that over-regulation could make these products more expensive or unavailable and I am not confident the Act would have improved approval times for new medicines.
“To provide certainty to industry, consumers and practitioners the TPA will be repealed in full. It is my intention that the repeal Bill passes before the end of the year.”
Most provisions in the Act were intended to come into force 1 September 2026. As the Act will be repealed before this date, the repeal will not require businesses or practitioners to change the way they currently work and operate and there will be no disruption to consumers.
“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,” Ms Costello says.
“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.”
Later this year, the Government will consider proposals for new legislation that will streamline the way in which new medicines are approved and ensure that regulation supports innovation in health and medical products and economic growth.
“There will be engagement with key groups through this process. 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 so that we develop the best possible law and frameworks.”
Repealing the TPA are commitments in the National-New Zealand First and National-ACT coalition agreements.
Media contact: Richard Ninness +64 21 807 136
Editor’s notes:
The Therapeutic Products Bill was introduced to the House on 30 November 2022 and the Therapeutics Act 2023 received Royal Assent on 26 July 2023.
Therapeutic products covered by the Act included medicines, medical devices (such as bandages, hospital beds and surgical equipment) and natural health products.
In 2023, the Health Select Committee considering the Bill reviewed more than 16,500 submissions and heard submissions from more than 300 organisations and individuals. Over 95% of submissions opposed the Bill, mostly due to the inclusion of natural health products.
The regulatory regime required to support the TPA, including the creation of a new regulatory agency and IT systems, had still to be developed and this work was unfunded. Until new legislation is passed, the Medicines Act and Dietary Supplement Regulations which are currently in place will continue to apply.
