Late last week the Ministry of Health posted an update on Therapeutic and Natural Health Products Regulations, which represents a significant development for our sector. Although we support the proposed regulation of Natural Health Products in a discrete part of the Therapeutic Products Bill in principle, it is not permitting “Therapeutic” claims only “Health Benefit” claims.
Our legislative goals
We have been working intensively with officials and ministers over the past year, with our primary objectives being to achieve a modern, fit-for-purpose regulatory regime that delivers…
- products which contain safe ingredients at a safe dose
- high quality manufacturing processes in place to provide assurance that products are not contaminated
- product information which is clear on the use and recommended dose
- therapeutic health claims which are based on appropriate evidence
- New Zealand producers to be in a positive position in the global marketplace
In December 2020 we were informed the Government intended to incorporate natural health products (NHPs) into the Therapeutic Products Bill because it was the fastest route to regulatory reform. We felt this was a reasonable approach because natural health products could be classified as therapeutic products with therapeutic claims. Unfortunately, the proposed Bill fails to deliver on this.
Two significant things need to change
1. Therapeutic claims must be permitted for natural health products under the proposed Therapeutics Bill
Ministry of Health documents state: “… natural health products are not therapeutic products and will not be regulated as such”. This decision means product claims are likely to be very limited under this legislation. We have repeatedly requested and not received clarification of what claims or types of claims will be included/excluded.
We believe this impasse can be resolved. The proposed legislation provides the Government with the opportunity to update the outdated 1981 Medicine Act’s definition of therapeutic purpose so it can be enabled in the Therapeutic Products Bill.
2. Amend the Bill to permit all the claims that Canada and Australia do
Doing this will automatically make it clear which claims will be included / excluded. There has been a high degree of integrity in the way those countries’ permitted claims have been assessed.
Aligning this country’s permitted claims for NHPs with Australia’s and Canada’s will quickly resolve our sector’s export market roadblocks by enabling us to compete effectively in the global market.
The inclusion of a fit for purpose vehicle to enable future new claims which are supported by appropriate scientific or traditional use evidence.
Next steps and what you can do
- Natural Health Products NZ is surprised and disappointed that the Ministry of Health has not included these critical elements after our extensive engagement with them to date.
- To ensure the outcome is both fair and workable for all, Natural Health Products NZ will continue advocating for fit-for-purpose regulations.
- Natural Health Products NZ will continue to request industry involvement in the Ministry’s expert advisory decisions concerning NHP scheduling, listing, pharmacovigilance and other regulatory decisions affecting our industry.
- Natural Health Products NZ has heavily invested over the years to help ensure the Ministry develops fit for purpose, world class and best practice regulations for our industry.
- Natural Health Products NZ will only be in a position to support this legislation if the key changes are addressed.
We encourage you to read the following documentation of briefings and decisions made to date and to email us your feedback on any aspect (particularly around claims):
