Devil will be in the detail: New Zealand a step closer to natural health products regulatory revamp
The New Zealand natural health products (NHPs) industry has been clamouring for new regulations for years. Although a Natural Health Products Bill was introduced in 2011, it was withdrawn after six years of going through parliamentary processes in 2017 following a change in government.
Five years on, the government formally introduced a new bill for NHPs, known as the Therapeutic Products Bill on November 30, after engaging the industry and key stakeholders.
When enacted, the bill will replace the Medicines Act 1981 and Dietary Supplements Regulations 1985 and will provide regulations for all NHPs.
The bill would open the way for NHPs to make health benefit claims, the Ministry of Health announced.
Health benefit claims include maintaining and promoting health, the relief of symptoms and nutritional supplementation, such as vitamins and minerals.
Updates from the Ministry also said that there would be potential for the regulator to develop pre-authorised claims for other therapeutic purposes. These claims would need to be substantiated.
Aside from health benefit claims, the bill will allow for a list of permitted NHP ingredients to be developed in secondary legislation.
The authorisation of NHPs will be via a self-assessment or declaration pathway.
While this would be a less onerous process as compared to those governing medicines or medical devices, the regulator would still be allowed to take appropriate safety actions such as product recalls.
“The Therapeutic Products Bill is a flexible regulatory framework for how therapeutic products are manufactured, prescribed, imported, advertised, supplied and exported, and makes the regulation of clinical trials more robust.
“Having a modern set of laws and regulations that line up with international practices will also help our medicines and natural health products industries to export to the world.
“The Therapeutic Products Bill has been more than a decade in the making and, alongside the Pae Ora (Health Futures) Act, will contribute to building a health system New Zealanders expect and deserve,” health minister Andrew Little said.
Natural Health Products NZ (NHPNZ), which represents around 80 per cent of the country’s NHPs industry, said it welcomed the government’s move, but cautioned that the devil would be in the detail.
“We are still working through the Bill’s detail, but hope it will better enable exports, support consumer safety and also allow consumers to be given accurate, evidence based-information about natural health products’ health benefits,” Samantha Gray, government affairs director of the industry body said.
She added that the NHP sector has been contributing over $2.3 billion to the New Zealand economy each year, but more could be done if there were modern, fit-for-purpose regulations.
“We are calling on all parties to support this Bill’s passage into law and also to support the regulations being finalised as soon as possible,” she said.
Who will enforce the rules?
To enforce the bill, a new regulatory unit will be set up within the Ministry of Health, also known as the Manatū Hauora in the Māori language.
An independent statutory officer will be appointed by the director general of Ministry of Health and the ministry will head the unit which will work independently of the director general and health minister.
After the introduction of the bill in the parliament, the bill will go through its first reading where members of the parliament would debate and vote on the bill.
Following which, public feedback would be consulted when the bill reaches the Select Committee stage, and it will take a number of years for the bill to be formally implemented.
The Therapeutic Products Bill will also regulate the imports and exports of NHPs.
For example, there will be a general requirement where most NHPs will need to obtain a ‘market authorisation’ before being imported into, supplied in or exported from New Zealand.
There will also be provisions to support exports and innovation through exemptions to meet requirements in importing countries, and improved export certifications.
The new regime will also authorise natural health practitioners to manufacture and supply NHPs to their clients as part of a health consultation.