- The Government has re-introduced the Therapeutic Products Bill, regulating low-risk natural health products.
- It creates a regulatory authority potentially affecting at least 50% of Kiwis.
- Concern about overreach was a factor in previous legislation being withdrawn.
- Traditional Māori medicinal practices (raongā) will be exempt, but that may have pros and cons.
What is the Therapeutic Products Bill?
The Government has introduced the Therapeutic Products Bill. The proposed bill will control all aspects of natural health products (NHPs), regulating them in their own category. The bill replaces the Medicines Act 1981 and Dietary Supplements Regulations 1985.
NHPs that could end up being regulated run the whole gamut, including vitamin and mineral supplements, homeopathic remedies, and some remedies based on animal products, such as fish oil capsules. NHPs are used by over 50% of the population.
Why do we need it?
Currently some supplements, at higher concentrations, would be categorised as medicines. That would require regulation under the Medicines Act. Conversely, dietary supplements under the current regime are classified as “foods” and are therefore exempt from testing for efficacy or toxicity.
Also, many NHPs are promoted with vague marketing terms because current laws don’t allow manufacturers to make explicit therapeutic claims even with supportive clinical evidence.
The bill will also regulate the imports and exports of NHPs, which may boost the big players that already deal with similar restrictions or boost the export market with additional credibility, but are more likely to hurt smaller businesses.
A new regulatory body under MoH
Enforcement will be through a new regulatory unit with a regulator appointed by the Ministry of Health’s director general. The regulator will be responsible for the safety, quality, and efficacy of NHPs.
The regulator will also have the capability to determine criminal offences and the power to issue fines.
Concerns about the bill’s implications
From a health and safety perspective, there is little evidence NHPs pose a serious health risk to consumers under the current regime. There’s also concern that added regulatory costs may be passed onto the consumer.
Also, critics contend the bill doesn’t clearly specify what factors should influence regulatory and enforcement decisions. The risk of a new regulatory body with considerable sway, including what products are covered and what are not, means there is risk of governmental overreach and mission creep.
Traditional Māori health practices exempt
However, that concern does not extend to traditional Māori medicinal practices (rongoā Māori) because those NHPs are exempt from the bill. The Government has enacted a workstream to look at rongoā separately.
That said, by staying out of the regulatory framework, the Government is concerned Māori practitioners may miss out on lucrative export markets.
Associate Health Minister Peeni Henare says “Officials within the workstream will analyse the Therapeutic Products Bill to identify any gaps and opportunities to protect rongoā Māori, assure whānau safety, and ensure access to the export market for practitioners.”
The Government is also considering questions regarding intellectual property rights, if exported.
The public has until 15 February 2023 to submit comments on the bill.