Natural health products are a $2.3 billion sector. Photo / 123RF
The natural health product industry says a gaping hole in proposed new sector legislation means a $500 million a year export roadblock and information vacuum for New Zealanders will continue.
Natural Health Products NZ, which says it represents 80 per cent of dietary supplement and natural health product companies in the $2.3 billion sector, is alarmed that an update on the Therapeutics Products Bill shows it excludes the very thing a year of discussions with Government officials and ministers has sought: to permit evidence-based therapeutic claims for natural health products.
The organisation wants the bill amended to allow all therapeutic and health claims that Australia and Canada allows.
It's calling on the Government to use the opportunity to update the "outdated" 1981 Medicines Act's definition of "therapeutic" so it can be enabled in the proposed new legislation.
The Medicines Act and Dietary Supplements Regulations prohibits therapeutic claims unless a product is a medicine.
"There has been a high degree of integrity in the way Australia and Canada's natural health product permitted claims have been assessed," said Natural Health Products NZ government affairs director Samantha Gray.
"Aligning this country's claims with Australia's and Canada's will quickly resolve our sector's export market roadblocks by enabling new Zealand to compete effectively in the global market - something that is not currently possible.
"The export potential is huge. We estimate that in 2019 our lack of an export-only exemption and the failure of regulatory reform cost us up to $500 million in lost opportunity globally."
The estimate was based on a comparison with Australia's export performance in the sector and benchmarking to sectors where New Zealand, which has a strong reputation for product integrity and safety, performs well globally, such as dairy and honey, Gray said.
The Ministry of Health told the Herald it was "working to enable evidence-based claims for natural health products under the new legislation".
The bill was being redrafted and was expected to be introduced to Parliament late this year.
"We want to create a pathway to enable these claims so consumers are able to make informed decisions about their own health and wellbeing, and to support industry and the sector."
The ministry said it had been "liaising closely" with Health Canada and the Australian Therapeutic Goods Administration. They had provided "valuable insights" on how their regulatory regimes for natural health products worked in practice and the issues they continued to address, including with compliance and enforcement.
"We are undertaking further work to compare their regimes with our proposed regime."
The ministry's response that the bill is still being worked on is little comfort to Natural Health Products NZ.
Gray: "The key point is the ministry's recent Therapeutic Products Bill update did not contain our core non-negotiable request to permit evidence-based therapeutic claims for natural health products.
"In fact, the update made it clear that the ministry intended to do exactly the opposite so it can't be added as a detail later on because that part of the proposed framework provides for an entirely different scenario.
"Making no provision for evidence-based therapeutic claims for natural health products could result in a worst of both worlds scenario whereby our members are not allowed to make therapeutic claims on their products yet are saddled with new compliance requirements and costs."
Gray said on survey results, the natural health products sector's compound annual growth rate between 2014 and 2019 was 64 per cent.
"One can only imagine how much bigger that would be if the export-only exemption was enabled and we had achieved regulatory reform allowing consumers to be properly informed about the products they are purchasing."
Gray said the Ministry of Health refused to clarify what claims or types of product claims will be included or excluded in the regulations.
The ministry said it was aware of the organisation's concerns and would continue to work with it to address them.
"As part of the ministry's work on the new Bill, we are addressing feedback from stakeholders and submitters on the 2019 draft exposure Therapeutic Products Bill. The decision to include natural health products under the new Bill was made more recently and there is ongoing work on what the specific provisions for natural health products will look like.
"The Bill is being redrafted and is expected to be introduced to Parliament in late 2022. There will be an opportunity for stakeholders to make submissions on the Bill when it is considered at select committee."