Therapeutic Products Bill

As you know Jacinda Ardern has resigned and the new prime minister Chris Hipkins has ordered a rapid review of legislation that should be prioritised before the election in October 2023.

We have no problems with the Therapeutic Products bill replacing the 1981 Medicines Act, but demand that the government undertakes its promise that natural health products would not be regulated by the same legislation as pharmaceuticals and that they remove natural health products from the Therapeutic Products Bill.

Including natural health products within a pharmaceutical regulatory regime will be heavy handed regulation of a low-risk industry, will restrict the sale of products to those that only contain permitted substances, require all products to be notified at a fee, restrict the type of health benefit claims that could be made, and impose significant compliance costs on manufacturers and suppliers.

The Therapeutic Products bill is based on the fallacy that it would increase exports and provide consumer safety. However, an intelligent assessment proves there is no substance to support either of these claims. Industrially produced natural health products pose a de minimis risk of safety. There is no legitimate “safety” problem that needs to be ‘corrected’ by such a law.

The Therapeutic Products Bill is now the third attempt by a Labour Government to regulate natural health products extensively used by New Zealanders. This new bill which encompasses all the previous provisions and attempts to introduce legislation for natural health products, establishes a single regulator with the power to restrict access to natural health products.

We believe that it is a fundamental right for individual consumers to take responsibility for their own health and well-being and to make their own decisions from a range of effective and safe products and therapies. Being responsible for looking after our own health is the most fundamental of human rights.

Points for consideration

Natural Health Products in New Zealand are presently regulated under a ‘Black-list’ (a short list of banned substances that have shown evidence of harm). We currently have the right to consume any Natural Health ingredients not on the ‘Black-list’, which gives us access to an unquantifiably high number of ingredients with no history of harm.

Under the new bill this present ‘Black-list’ approach will certainly be replaced by a new ‘White-list’ approach, with a limited ‘White-list’ of ‘permitted ingredients’. Any ingredient that is not on this permitted ‘White-list’ will not be allowed to be sold in New Zealand. Many Natural Health Products will disappear if they contain even one ingredient that is not on their ‘Permitted White-list’. Many suppliers will also disappear as a result.

It should also be noted that any natural health product containing an ingredient that is recognised as having a therapeutic (health improving) effect can be re-classified as a medicine by the Ministry of Health. Once it is classified as a medicine, it will be black-listed for use in natural health products. (This is already happening).

There is no accountability for harm or death as a result of consumers losing healthcare products that they depend on. There are no provisions in the Therapeutic Products Bill to make allowances for this if it does happen. The passing of the Therapeutic Products Bill will result in many natural health products becoming either severely restricted (via new proposed low dosage limits), or being made outright illegal for use in New Zealand.

We are aware that some practitioner organisations have been hoodwinked into believing that products presently classified as ‘Practitioner Only Range’ will not be exempt from the ingredient restrictions. However, our interpretation of the Therapeutic Products Bill administered by a single pharmaceutically minded regulator, and from the previous attempts to introduce such legislation, differs from this entirely in that Māori health practitioners and others using traditional herbal and other remedies to administer to an individual will be unable to use non-permitted ingredients. We feel this is a classic example of how unreliable and misleading the Ministry’s information is in relation to this bill. To make matters even more uncertain the bill is crafted to allow most of the detail to be added after the bill has been passed!

The proposed financing model of the new system presents significant risk to the majority of New Zealand small business supplement manufacturers, an outcome likely to result in only a small handful of large manufacturers remaining viable. This will result in a significant loss of variety of product in the natural supplements market in New Zealand.

We are concerned that the agreement by the current government to provide regulation for dietary supplements under a separate Natural Health Products Act, has been changed and these products will now fall under the Therapeutic Products Bill as Natural Health Products (NHPs) and believe that this bill should not progress. The proposal to establish natural health products under a new structure will add significant costs to manufacturers of these products, due to additional compliance and barriers to trade. We see the Therapeutic Products Bill regime as establishing a similar body to the Australian Therapeutic Goods Administration, which places huge costs on the natural health sector, stifling innovation and limits product availability.

We strongly oppose the inclusion of Natural Health Products (NHPs) within the Therapeutic Products Bill and respectfully request that all sections contained in the bill that encompass natural health products, be removed in their entirety, and that any and all regulation of natural health products be upgraded and placed under Food Act regulation as promised by the previous government.

The inclusion of Natural Health Products (NHPs) within the Therapeutic Products Bill will add significant cost to businesses through licensing and sponsor application costs alone.

While we are yet to see the exact regulations and rules that will be written and introduced by the regulator, any specific requirements for New Zealand manufacturers, such as the added cost for relabelling, approval costs and potentially (GMP) Good Manufacturing Practice auditing, will significantly affect small businesses.

We believe that the two previous bills relating to Natural Health Products (NHPs) that were dropped by the previous government, had seen significant regulations drafted by the Ministry of Health which would have added similar costs to those faced by manufacturers in Australia under their Therapeutic Goods Administration.

We suspect that those regulations would be revisited should Natural Health Products (NHPs) be established under this bill.

Natural Health Products (NHPs) and Therapeutic definition within the Therapeutic Products Bill

In section 30 of the Therapeutic Products Bill relating to “definition”, it states that natural health products will be those that are “therapeutic” and consist of one or more of the ingredients cited. This statement is of concern, as Section 15 sets out that “therapeutic purposes” to include under subclause (a) “Preventing, alleviating for such issues as an ailment or injury”. Currently under the 1981 Medicines Act any product that claims to have a “therapeutic purpose” is automatically captured as a medicine under the Medicines Act.

We therefore strongly recommend that all reference to “therapeutic purposes” relating to natural health products be removed from the Therapeutic Products Bill.