Regulating the use of natural health products is on the agenda again.
Minister of Health Andrew Little plans to revive the Natural Health Products Bill that was abandoned in 2017, before its third reading.
Wary consumers may see this as another power grab that detracts from personal health choices and steers us towards pharmaceuticals.
But the Government says it aims for a ‘modern, comprehensive, cost effective regulatory regime for therapeutic products and natural health products’.
Draft principles include that ‘the likely benefits should outweigh the likely risks’.
The Therapeutic Products Bill is expected to reach Select Committee stage at the end of 2022 or early 2023.
The Ministry says it will ‘take on board new health technology changes and lessons from COVID-19’.
What COVID-19 has produced is a deep distrust in any regulations seen to breach human rights and threaten individual health choices.
Together with distrust of the pharmaceutical industry, the government may see opposition to any law that may restrict the availability of traditional natural products.
The Bill will regulate how products are manufactured, tested, imported, promoted, supplied, and exported. This will include regulating medicines from general sale products like paracetamol to gene, cell and tissue therapies, and medical devices that range from tongue depressors to implantable pacemakers.
The Bill intends to regulate natural health products that are for retail sale, where consumers’ main information source is the label and the company’s website.
Products supplied to clients via consultation from a health practitioner, including a natural health practitioner, will not be regulated.
Natural health products are made from natural ingredients, or synthetic equivalents such as synthetic vitamins. They include herbal remedies, in the form of capsules, tonics, and skin creams, vitamin and mineral supplements, traditional Māori remedies, traditional Chinese medicine, homeopathic remedies, and some remedies based on animal products, such as deer velvet and fish oil capsules.
The Bill will provide for the protection and recognition of rongoā Māori.
Safe manufacturing is a key objective of the Bill.
Compliance will be monitored through regular site audits by an independent local regulator.
The Ministry of Health consulted on a draft of the Bill from December 2018 to April 2019. Four hundred and forty-two submissions were received from a variety of stakeholders.
The Ministry has collated a list of more than 5000 substances that are considered to be low risk and allowable to be used in notified natural health products.
A Medsafe Medicines Classification Committee will reconsider a selection of substances where restrictions are placed on them by the Medicines Regulations.
For example, the committee has publicly notified that a common form of folate (levomefolate) is on their agenda for classification as a medicine.This may attract opposition, with some in the health industry arguing that there is a high level of safety for this ingredient and there is no good reason for there to be a change to the use of levomefolate in foods, supplemented foods and dietary supplements.
To conclude, at this stage there is little fine detail but be alert. When the Bill reaches the select committee stage, there will be an opportunity for you to have your say.
There will also be opportunities during consultation on the regulations.
View more information at:
https://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime