New era for therapeutic products regulation
Today’s passage of the Therapeutic Products Bill marks the most significant change to the regulation of medicines, medical devices and natural health products in nearly 40 years, Minister of Health Dr Ayesha Verrall says.
“This is a milestone for the regulation of therapeutic products in Aotearoa New Zealand, and will better protect, promote and improve the health of New Zealanders.
“The Bill provides New Zealanders with the assurances they deserve about the safety and quality of therapeutic products. It strikes the right balance in regulating these products according to their different risks and benefits,” Ayesha Verrall said.
As well as replacing and modernising the regulatory arrangements for medicines, the Bill will provide fit-for-purpose regulation of medical devices and cell, gene and tissue therapies which, until now, have not been fully regulated.
It will also be the first time New Zealand has comprehensive risk-proportionate regulation in place for natural health products.
“The Bill will bring our country into line with our international counterparts, support innovation and ensure effective control over quickly evolving health technologies,” Ayesha Verrall said.
“Without legislation like this to help guide, evaluate and test emerging health technologies, New Zealand would continue to face difficulties developing or introducing to market necessary and high-quality therapeutic products.”
Changes made to the Bill during its final progress through the House this week strengthen the controls that can be placed on advertisements involving therapeutic products. Currently medicines, including prescription medicines, can be advertised subject to strict controls under the Medicines Act.
“The changes come as a result of talking and listening to experts about their concerns that direct-to-consumer marketing causes undue harm, and allow for future regulations restricting these practices,” Ayesha Verrall said.
“I acknowledge direct advertising of medicines is a controversial area and I am confident the Bill strikes the right balance in regulating advertising in a manner that respects the right of New Zealanders to share and receive information.”
As previously signalled, the Bill includes an exemption scheme for small scale natural health product manufacturers and removes obligations which might otherwise have applied to rongoā [traditional Māori medicine] practitioners, services and activities.
“Proposed changes to the Bill will ensure whānau can continue to use, create, and manage rongoā as they have for generations.”
Most provisions in the Bill will come into force in mid to late 2026, with the establishment of a new, independent regulator to oversee the regime.
This will follow the development of secondary legislation, including regulations and rules, involving consultation with stakeholders.
The Therapeutic Products Bill was introduced to the House on 30 November 2022.
The Health Select Committee considered the Bill, reviewing more than 16,500 submissions and hearing submissions from more than 300 organisations and individuals.
The purpose of the Bill is to protect, promote and improve the health of all New Zealanders by providing for the:
- Acceptable safety, quality and efficacy or performance of medicines, medical devices and active pharmaceutical ingredients across their life cycle; and
- Acceptable safety and quality of natural health products across their life cycle and the substantiation of health benefit claims.
The Bill will replace the Medicines Act (1981) and the Dietary Supplements Regulations 1985.
The Medicines Act currently provides insufficient coverage of the many products used in modern healthcare delivery. And the Dietary Supplements Regulations are not fit for purpose, are inflexible and out of date.