The government will consider proposals for new legislations governing natural health products later this 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,” said associate health minister Casey Costello on May 8.
“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,” she continued.
Key stakeholders, including consumers, industry, and practitioners will be engaged in the process of developing the new regulatory regime.
Costello hopes that the repeal Bill for the Therapeutic Products Act will be passed before the end of this year.
Parts of Therapeutic Products Act were welcomed as a step in modernising New Zealand’s outdated natural health products regulations that were formed in the 1980s.
Under the old regime, dietary supplements are not allowed to state or imply therapeutic purposes. Natural health products are also not allowed to make therapeutic claims.
The Therapeutic Products Act was previously set to replace the old regulatory regime from September 1, 2026.
Products covered by the Act included medicines, medical devices (such as bandages, hospital beds and surgical equipment), and natural health products.
Industry urges ministerial action
Industry body Natural Health Products NZ (NHPNZ) said the repeal would mean that urgent ministerial action was required.
Samantha Gray, government affairs director at NHPNZ, said the industry was worried that it would take years for the new replacement regulations to come into place.
“While the TPA made some important improvements, it was overly bureaucratic and costly to comply with. However, we are concerned that a full repeal and replacement means this problem will drag on for years. New Zealand exporters cannot wait that long.”
The Therapeutic Products Act was welcomed for exempting small-scale natural health products manufacturers that sell products locally from having to obtain product authorisation or manufacturing license.
However, natural health products that are imported, supplied by wholesale, or exported, will still need to undergo the product authorisation process.
“The need for action is urgent. New Zealand’s own outdated regulations mean our exporters are at a competitive disadvantage internationally and are essentially blocked from exporting to some markets,” Gray said.
With the right suite of regulations in place, she said that the industry members have estimated that exports could have doubled.
The industry currently exports more than NZ$650 million (US$389m) of therapeutic products every year and employs thousands of New Zealanders.
The industry body is now seeking for an export exemption to help natural health products firms.
“We look forward to working with the Minister on the TPA’s replacement but in advance of this our sector needs an export exemption that will allow New Zealand exporters to sell our products to the world on an equal footing with our competitors.
“It’s important the Minister acts with urgency to provide this export exemption,” said Gray.
TPA not the solution?
Costello explained that the Therapeutic Products Act would be removed as it “was not the solution.”
“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,” she said.
She added that the government is in fact, listening to the concerns of the industry and consumers by repealing the Act.
“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,” she said.