Bill holds far reaching implications for users of natural health products
The closing date for submissions is February 15.
So our government wants to regulate the use of available herbs, spices and natural remedies, for the sake of consumer safety.
The Therapeutic Products Bill is intended to replace the Medicines Act 1981 and the Dietary Supplements Regulations 1985 to provide regulation of therapeutic products, such as medicines, medical devices, natural health products, and pharmaceutical ingredients.
Its purpose is to protect, promote, and improve the health of all New Zealanders by providing for the acceptable safety, quality, and efficacy or performance of medicines, medical devices, and active pharmaceutical ingredients.
The regulations will be able to prohibit all activity with a product if it directly or indirectly exposes any individual to a risk of death, serious injury, or serious illness,
You may be disappointed however if you think there may be a new focus on unsafe-for-many COVID-19 mRNA vaccines.The Minister of Health must not recommend that regulations be made about a product if the product is adequately regulated by other means.
The government is focussing more on market standards for the quality of products such as Vitamin C tablets.
The 423 part bill:
requires therapeutic products to receive a market authorisation before they could be imported into, exported from, or supplied in New Zealand,
provides for the regulation of a range of controlled activities
provides for a new appointed Regulator who will be given far reaching powers, including the ability to recover costs from those who are regulated.
Products covered are
medicines include pain relief available at supermarkets (such as paracetamol), vaccines, chemotherapy medicines, and patient-specific genetic treatments:
medical devices include products ranging from tongue depressors and bandages to implantable devices (such as pace makers), diagnostic software, and robotic surgery machines:
active ingredients of medicines:
Natural health products 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 Regulator will be a public servant appointed by the director-general of health.
The Regulator will decide what can be sold openly and what should be restricted.
The Regulator may rely on decisions of recognised overseas entities.
The Regulator may establish one or more advisory committees. (Committee members are appointed on the terms and conditions determined by the Regulator).
The Regulator is not bound by an advisory committee and may rely on assessments made by an overseas organisation.
The Regulator will be able to seek injunctions and enter premises to enforce compliance.
However:
The Regulator must have arrangements in place to avoid or manage conflicts of interest..
The Regulator must ensure they can understand and give effect to the principles of te Tiriti o Waitangi/the Treaty of Waitangi; and to understand and take account of mātauranga Māori and Māori perspectives in relation to therapeutic products.
In a nutshell, the Regulator will regulate the availability and use of therapeutic products, issuing market authorisations, grant licences and permits, regulate the controlled activities and supply chain activities, carry out post-market surveillance and engage and co-operate with overseas organisations.
Homeopath Barbara Roberts opposes the bill and urges people to make submissions.
“Costs will only increase with this bill, making preventative health a luxury”, she predicts.
She has studied its hundreds of clauses and raises many concerns for those who use natural products to maintain health.
“The Medicines Act and the Dietary Supplements Regulations arguably need updating but there are a large number of areas that are problematic for users and practitioners of a wide range of complementary health modalities”, she says: “If you use homeopathy, herbs or supplements and want to continue to have the freedom of choice for modalities and practitioners and the choice of herbs, supplements and remedies, if you want to be able to support micro and small businesses and individual practitioners then please make a submission.”
“Clause 30 defines what natural health product ingredients are. If you use locally sourced herbal products grown from a micro business, this clause defines them as a natural health product, which has implications further on in the bill. It includes plant and non-human animal extracts, vitamins, minerals, amino acids and ingredients to formulate these. Under this clause placenta capsules, made from your own placenta after birth would not be possible, for example.”
Clause 69 makes manufacturing, or exporting natural health products and importing a low concentration natural health product a controlled activity - that is prohibited unless allowed by licence. “You want to send some Kawakawa balm to your cousin in Australia? Nope, can’t happen as that would be exporting a natural health product.” Roberts submits that all low concentration natural health products should be exempt because there is no risk of disease from them.
Small businesses will not be able to sell herbal tinctures unless they have a consultation with each sale, and they cannot supply wholesale to a shop.
Breaches of the regulations carry punishing and frightening penalties. An individual could be liable for a $200,000 fine and/or 5 years in prison. “This may make many small businesses unable to talk about what sorts of things their herbal tinctures or aromatherapy ointments could be used as this is making a claim and the fines are out of proportion to income for these micro businesses. Could my posts be construed as making claims? - possibly.”
The bill allows that decisions made overseas can be adopted by New Zealand. “With this clause we open the door to losing sovereignty, with the regulator able to adopt and follow agendas from overseas. This is also risky for our Rongoā Māori and Treaty of Waitangi obligations as no other country has any understanding of Te Ao Māori”, Roberts says.
Under clause 71, there will be no injection or parenteral infusion of natural health products. “This means no IV Vitamin C. It also means no IM Vitamin B12 which is a standard treatment and no iron infusions, so it will be a disaster for conventional medical treatment also.”
Even if the advisory committee make a recommendation it doesn’t need to be upheld. That’s as a major concern for natural health products if the Regulator has any biases or is subject to outside agendas.
Food safety and natural medicine advocate Guy Hatchard also opposes the bill. He points out out that a recent EU study found that natural health products are 45,000 times safer than pharmaceutical drugs.
Public consultation closes on February 15.
Therapeutic products are medicines, medical devices, natural health products, and active pharmaceutical ingredients.
They include medicines made from biological components, gene therapies, and advanced cell and tissue therapies; and medical devices that are software, production systems, whole organs, and tissue grafts; and; natural health products that are traditional and herbal medicines, and vitamin and mineral supplements.
Sources
The Bill
Therapeutic Products Bill 204-1 (2022), Government Bill Contents
Explanatory notes - homeopathics
Make a submission
Therapeutic Products Bill - New Zealand Parliament
Medsafe
https://www.medsafe.govt.nz/COVID-19/safety-report-46.asp#death
Impact of the bill - Hatchard
Deaths due to medical error, 2016
Study Suggests Medical Errors Now Third Leading Cause of Death in the U.S. - 05/03/2016
Harm from prescription drugs
Our prescription drugs kill us in large numbers
Adverse drug events are prevalent and preventable
How Can We Trust Institutions that Lied?
https://brownstone.org/articles/how-can-we-trust-institutions-that-lied/
Make a submission