The Government’s new commitment to making changes to the Therapeutic Products Bill to lower the burden for natural health product producers is positive but more needs to be done to provide certainty for the sector, says Natural Health Products NZ’s Government Affairs Director Samantha Gray.

Natural Health Products NZ is the industry’s peak body, with over 140 members and representing around 80% of the sector. The industry is a significant and growing contributor to New Zealand’s economy, contributing more than $2.3 billion per annum.

“We have been calling for a modern, fit for purpose regulatory system for many years. The natural health products industry is being held back by broken regulations. But it is important that the government gets it right and does not impose new and undue burdens that put the industry at risk.

“The Therapeutic Products Bill contains some significant improvements to regulation of Natural Health Products, including permitting natural health products to make evidence-based health benefit claims and growing international trade by way of an export-only exemption. However, the Bill as reported back by the Health Select Committee still contains undue red tape for our members.

“We remain concerned about the burden the Therapeutic Products Bill places on natural health product manufacturers, whether the new Regulator will be able to effectively regulate the many thousands of natural health products in the market, and the cost that businesses will have to bear to go through the Regulator’s approval system.

“Given the low-risk nature of natural health products compared to medicines, we believe it would be more appropriate to use a notification process where the manufacturer or supplier declares that the NHP product conforms to requirements in the regulations and rules, and supplies the required information to the Regulator on request, rather than the Bill’s requirements for authorisation. A notification process is recognised as global best-practice for natural health products.

“We welcome the Government’s commitment to making changes so small-scale NHP producers won’t need to obtain a product authorisation or manufacturing licence where their products are made and supplied in-person to customers in New Zealand. But more changes are needed.

“The Government’s proposed changes promise some improvement but we are still some way off the modern legislation that is needed to allow the natural health products sector to thrive. We will continue to engage with the Government and other political parties towards making the new law fit for purpose,” says Samantha Gray.

Key changes needed to the Therapeutic Products Bill:

1. Adopt a notification, rather than authorisation, system for low-risk NHPs.
2. Recognise health benefit claims permitted by overseas regulators.
3. Adopt an export register, rather than authorisation, system for the sxport of low-risk NHPs.
4. Do not require product standards for NHPs
5. Reduce Regulator's costs to NHP sector
6. Improve accountability and resourcing of the Regulator
7. Structure of the Bill (dedicated NHP section so not overregulated by inadvertently being caught up in medicines level regulation)

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