Therapeutic Products Bill with a focus on Natural Health Products
Many of you will be unaware of a bill currently going through parliament that is set to transform the way that natural health products are managed throughout New Zealand. If passed we are likely to see a lot of small health product providers go out of business, an increase to the cost for natural health products but as always big businesses will make more money from you.
Who will this Bill impact?
The proposed Bill to regulate Natural Health Products (NHPs) will impact many people, including those who take basic supplements, healthcare providers and small New Zealand based businesses that can’t afford the new regulation costs. It won’t be some small segment of the population, potentially anyone that wants to take the occasional vitamin C tablet when they’ve got a cold is going to be affected by this.
The purpose for NHPs is already achieved through current legalisation
A major flaw with this new bill is that what it aims to do by regulating safety and quality is already done through existing legislation. If a healthcare provider or a health product is currently making claims that are untrue this is already illegal. The Dietary Supplements Regulations 1985 ensures that those marketing natural health products cannot make false or misleading claims, sets dosage limits, and mandates specific labelling requirements. This places the legal responsibility on those who put these products on the market to ensure that they are of an acceptable quality, safe for use, and comply with the law. Therefore, all the concerns that the proposed Bill aims to address are already being effectively regulated under current laws.
The major difference that is occurring here is that currently everyone has the freedom to produce, market and sell products until they do something wrong, at which point they’ll be held to account through the legal system. The new model will mean that instead no one is able to do anything until the central regulator allows them to.
Concerns about the Bill
The Bill proposes to take an approach of individually approving each ingredient used in NHPs, unlike the current legislation, which places the responsibility on the business. However, given that there are around 29,000 different supplements now available worldwide, this would be an administratively unnecessary task for businesses with little gain other than making it harder to obtain NHPs. Furthermore, there is no clear process, timeframe, or cost to get approval for NHPs. The additional red tape proposed will no doubt raise the cost of natural health products for the consumer, making preventative health more of a luxury.
The Bill proposes to regulate all therapeutic products under a single regulator appointed by the Director-General of Health (Clause 330). The regulator is given a lot of discretionary powers, and it is unclear if they will have experience in the area of natural health, which is important as they may be determining which products are safe and effective for natural health users.
The bill gives the framework without the detail so the regulator will be able to implement secondary legalisation without the checks and balances needed, leaving many unknowns.
Unlike current legislation where the responsibility lies with the business to be able to back up claims, under the proposed bill, it will lie with the regulator, and only approved statements about the benefits will be allowed to be expressed by individuals, natural health practitioners, and businesses. If they make a claim not permitted by the regulator, it could result in a fine of $200,000 or 5 years in prison (Clause 192 & Clause 252). This is a huge concern for freedom of speech.
It is unclear how the bill will impact other traditional medicine such as Rongoā Māori, as many of the medicinal herbs they use will need to be individually approved, adding an unnecessary burden to their work.
The most alarming part of this bill is it will wipe out small businesses and allow larger companies to have a monopoly on the market.
Other points noted
· Each natural ingredient will need to obtain market authorisation before they could be imported into, exported from, or supplied in New Zealand (Clause 9). This will make it more difficult to both import quality NHPs from overseas and to bring unique and innovative New Zealand NHPs and ingredients to market. Again, this is covered under current legalisation. No sending Kawakawa balm to your friend overseas.
· You will require a licence to manufacture, export or import natural health products (Clause 69). No at home making of NHPs which help keep costs lower and will remove most small business currently doing this.
· A Natural health practitioner will need to consult each client prior to prescribing an NHP (clause 112). No wholesales are allowed to other practitioners or being able to collect an NHP from another practitioner. Those small businesses selling herbal tinctures will not be able to do so unless they have a consultation with each sale, and they cannot supply wholesale to a shop.
· There is no indication that there will be an independent review of research provided by a company to get their therapeutic products approved. We’ve seen many times where a company’s own funded research will be particularly biased and cover up the risks or limitations in the product.
A Better way
I support the idea that it is important ensure safety and quality of natural health products, but it seems that instead this is likely to become a red tape exercise whereby the regulator takes the power from consumers and small business.
There are better approaches to ensure the safety and quality of natural health products. Most OECD nations regulate low-risk, natural form products alongside food, which is similar to what we currently do. The Commerce Commission already oversees anyone providing goods or services making false or misleading claims. Just not many people know about it!
What you can do
If you are concerned about this Bill, I encourage you to make your voice heard by submitting your thoughts to parliament. We don't need to create more red tape! Instead let's work towards a better solution that protects both consumers and small businesses. We have until 12pm Sunday the 5th of March to make a submission.
Make a submission here
Read the bill here
Regulation of Dietary Supplements (medsafe.govt.nz)
Dietary Supplements Regulations 1985 (SR 1985/208) (as at 01 March 2016) Contents – New Zealand Legislation