Natural Health Products Bill and Regulations

The Bill is likely to benefit large manufacturing companies that make supplements for the international market, rather than the small – medium sized natural health businesses that make and sell their products in New Zealand.

The Bill is largely identical to legislation already passed in Australia, Canada and the EU.

The Canadian version, upon which the Natural Health Products Bill is based, has led to the loss of around 20,000 products from health stores since its introduction in 2004.

Traditional medicines, including Te Rongoā Māori, are impacted the most. For example, approximately 25% of commonly used Ayurvedic ingredients are not on the ‘permitted’ list.

The Bill redefines ‘therapeutic’ to mean ‘medicinal’ and, therefore, subject to the Medicines Act 1981.

The Bill also moves natural health products from the category of ‘foods’ to ‘products requiring premarket authorisation’.

The public consultation period for making submissions on the regulations closed on 31st May 2016.

Stakeholders have not received any feedback on their submissions as yet and have had no assurances that their concerns are being heard.

If the Natural Health Products Bill was in fact the “low cost”, “light touch” regime suitable for “a low risk industry” that was originally pitched by the Ministry of Health, this would not be of concern to stakeholders.

However, the proposed regulations see natural health products being regulated more like “high risk” pharmaceutical drugs, than “low risk” natural health products.

The Bill doesn’t just need tweaking; it needs a complete re-build from the foundations up to ensure that small- to medium-sized natural health companies will still be here in the future.

The first principle of good regulatory practice is to identify the problems that a Bill seeks to rectify. This Bill has no such foundation.

Natural Health Products are already regulated under the Dietary Supplements Regulations 1985, the Medicines Act 1981 and with all claims required to be substantiated under the Fair Trading Act 1986.

The Natural Health Alliance is pro-legislation and we recognise that regulation of Natural Health Products needs to be reviewed and updated.

The Natural Health industry proposed a joint industry proposal ‘Natural and Traditional Health Products Bill’ in 2009.

The proposal provided a co-regulatory model, suitable for a very low-risk industry, and recognised the unique regulatory issues related to processed extracts that are different to pharmaceutical and food manufacturing requirements.

The Health Minister at the time welcomed the proposal, but 7 years of intervention from the MOH bureaucracy has transformed it back into a TGA / Health Canada style system.

We propose making changes to the existing Dietary Supplement regulations to incorporate aspects of the joint industry proposal.

We believe that we can lead with a unique regulatory scheme more fitting to our small, yet democratic, innovative country.

No.

There will be no genetic testing of species of plants to ensure that the correct plant or species is in the products.

It is likely that the names and amounts of non-active ingredients will not need to be disclosed on the label or to the public. This allows manufacturers to hide synthetic ingredients and additives in their products.

Synthetic ‘non-active’ ingredients (excipients) can be harmful and are commonly used by the pharmaceutical industry to make drugs and dietary supplements taste better, look better, cheaper to manufacture and/or easier to compound in high volumes.

Yes.

MoH and Medsafe are trying to get stakeholders to vote for full disclosure of proprietary formulas by saying that protecting their intellectual property (IP) will result in ‘significant’ costs to the industry and ‘medium to high risk’ of allergic reaction for consumers.

Medsafe have been unable to provide any evidence of any hospitalisations or deaths resulting from taking any natural health product in New Zealand, ever.

Peanut allergy accounts for 1-2% of hospitalisations per year, yet peanuts (a common food ingredient) are not regulated like medicines. Adverse Drug Reactions account for 3-6% of all hospital admissions and occur in 10-15% of hospitalised patients. Drug allergy occurs in 1-2% of hospital admissions and 3-5% of all hospitalised patients.

Despite this high incidence, Medsafe does not require drug manufacturers to make public disclosures of their proprietary formulas.

The Bill will actually make natural health products less safe by removing ingredients with a history of safe use and the products that contain them from the NZ market. The resultant loss of access to products that consumers rely on to maintain their health will result in harm by omission.

Potentially harmful excipients (non-active ingredients) won’t need to be listed on the label. This is also the case under the Australian Therapeutic Goods Administration.

The Bill encourages practitioners to make their own home-made tinctures for their clients from restricted herbs, rather than buy them from a GMP (Good Manufacturing Practice) certified supplier. This is a major concern for public safety.

Due to rising costs, we will see a reduction in consumers using preventive medicine, and an increase in chronic disease. This will put more strain on an already under-funded public healthcare system, while also driving more demand towards pharmaceutical companies.

The Bill makes natural health products less effective because it classifies all therapeutic products as medicines, making them subject to restrictions under the Medicines Act 1981. The Medicines Act already restricts therapeutic doses of nutrients such as Iron, Zinc, Iodine, Folic Acid, Potassium, Vitamin A and Vitamin D to pharmaceutical products only.

This can actually be harmful to the public who are unaware that they are not taking enough of a nutrient like Folic Acid to have a therapeutic effect.

A degree in Naturopathy in New Zealand now requires three years of full-time study in Herbal Medicine, Functional Medicine, Nutrition, Pharmacology and Manufacturing, Pathophysiology, Anatomy and Physiology and Clinical Diagnostics.

We want a regulatory model that recognises the ability of qualified Naturopaths and Medical Herbalists to prescribe therapeutic doses of these nutrients.

The Bill would restrict Natural Health Product claims to a list of pre-approved mild/self-limiting conditions provided by the Ministry of Health called “the proposed list of conditions about which claims can be made”.

So, even if there is substantial scientific evidence that a NHP can help with depression, autism, insomnia etc., the Bill does not make it legal to inform the public of these facts.

This again erodes freedom of choice as individuals will not know what options are available to them.

The Permitted Ingredients List is an amalgamation of the Australian TGA and Health Canada lists. Any ingredient not permitted in either Australia or Canada is not permitted in NZ, even if it is permitted in the other country. This makes it even more restrictive than the Australian TGA.

Sixty-one Maori herbs are ‘Pending’ on the PIL because there is “No record of food or medicinal use” or “No information found to inform safety of use”. This is not because these herbs are unsafe, but because the knowledge has been passed down orally and is not documented in research papers or formal texts.

This is true for any indigenous culture’s medicinal knowledge. The Bill restricts access to proven therapeutic doses of Natural Health Products and covers both ‘over-the-counter’ and ‘practitioner-only’ products.

The proposed Labeling Requirements are unnecessarily restrictive and go beyond the relative international benchmarks. A wide variety of valuable imported product will be lost as overseas manufacturers won’t change their labels to suit a market as small as New Zealand.

Overseas manufacturers will not disclose their intellectual property (proprietary formulas) to the public so those products won’t be sold here.

The Bill proposes a wide-ranging regime of fees for:

• Registering a Natural Health Product with the Ministry of Health (yearly fee of $170 +GST)
• Adding a new ingredient to the Ministry’s Permitted Ingredients List ($700 +GST)
• Adding conditions to the Ministry’s ‘list of conditions about which claims can be made’ ($2000 +GST)

This fee regime will have significant implications on the financial viability of the natural health industry.

To put this in context, a small company selling 200 products will have to pay approximately $40,000 per year just to register their products. Adding ingredients or conditions will increase this cost further.

As a result, businesses may choose not to register a product or will need to recover the costs by increasing prices, therefore consumers will see product improvement and choice diminish and costs rise – substantially.

The Bill proposes that all regulatory costs must be met by industry. This requires a provision for regular fee increases, with no limit set on how much they can be raised.

As products and businesses disappear the financial burden will fall upon a steadily diminishing pool of products and businesses. The resultant increases will cause further rounds of ‘product rationalisation’ and business closures.

This is very concerning for small to medium sized businesses because they know that even the current fee schedule is unrealistic.

Medsafe and the Ministry of Health are in control of the NHP Bill in New Zealand. That is equivalent to the Australian TGA model, which regulates both pharmaceuticals and natural health products in Australia.

If we look to how Australians have been affected by the TGA we get some clues as to what may happen here:

• The fees have risen to A$1475 to register a complementary medicine with an annual fee of A$1380. If clinical or toxicological data is not provided an additional A$9870 is charged.
• Only large pharmaceutical companies survived the inauguration of the TGA, and they bought out many of the small NHP companies
• The quality and efficacy of NHPs has suffered as a result
• The cost of NHPs to consumers has risen as manufacturers try to recoup the cost of regulation.

It will be prohibitively expensive for many small companies. They will have to hire a specialist researcher to do the work and subscribe to several Pharmacopoeias and scientific research sites ($1000+ per subscription).

The proposed regulations state that scientific evidence must show effectiveness in humans. There are very few human studies done on natural health products, unless they are being studied for their potential for making a new pharmaceutical drug.

Additionally, scientific studies typically use the same species or isolate for all of their studies so they can compare results. Thus we have very limited access to scientific studies in our field, especially on the range of species in natural health products.

A company can’t subscribe to a scientific research database like EBSCO unless they are a library or university.

If they can’t access the research or afford to hire someone the company won’t be able to sell the product in NZ.

Consumers of NHPs have a right to retain access to natural forms of nutrients, regardless of the availability of pharmaceutically derived nutrients.

Denying access to naturally sourced nutrients in therapeutic doses is a violation of the New Zealand Health & Disability Services Consumers’ Rights Regulations Act 1996 which states that:

RIGHT 4 - Right to Services of an Appropriate Standard

1. Every consumer has the right to have services provided with reasonable care and skill.
2. Every consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards.
3. Every consumer has the right to have services provided in a manner consistent with his or her needs.
4. Every consumer has the right to have services provided in a manner that minimises the potential harm to, and optimises the quality of life of, that consumer.
5. Every consumer has the right to co-operation among providers to ensure quality and continuity of services.

Yes, but they only have access to the ingredients on the permitted ingredients list, that are suitable for over-the-counter sale.

The proposed regulations state that “any natural health product made by a practitioner, to be administered to an individual who has sought the practitioner’s advice, is exempt from notification”.

The exemption is only from notification, meaning that the herbal tonic the practitioner just made doesn’t need to be registered with the Ministry before it is handed to the client. Access to ingredients for the herbal tonic is still restricted to those on the Permitted Ingredients List.

It is nowhere near enough. There are approximately 12,000 medicinal plants worldwide and that doesn’t account for nutrients.

We need to support plant biodiversity by using traditional medicines from other cultures, or those important medicines will become obsolete. It will even affect the development of many life-saving drugs. The World Health Organisation states:

“We rely on biodiversity to produce traditional medicines and aide in the development of pharmaceuticals that keep our communities healthy. Plant biodiversity provides both health and economic benefits, as plants have been the single greatest source of natural medicines to date – from aspirin to cancer drugs. When we lose plant species, we lose the opportunity to discover potential drugs in the future.” (WHO, 2015)

The ingredients that make up Natural Health Products can be compared to the links on a chain, where the loss of just one link destroys the chain.

Good Regulatory Practice would focus on retaining the current ‘black list’ principle - placing reasonable restrictions on the tiny number of natural ingredients that are known to be harmful, as opposed to classifyng all ingredients as ‘prohibited unless permitted’.

The current regulations have achieved this cost effectively with an unblemished safety record since 1981.