Ed note: The NZ Health Freedom Trust has produced an update on the situation with the Natural Health and Supplementary Products Bill.

Key facts from this update are below:

IMPORTANT UPDATE: Since this post was written, the deadline for submissions on one of the Ministry of Health Consultations has changed. It is now March 4, 2016.

Effects, Consequences & Implications for Consumers of the Natural Health & Supplementary Products Bill

 

Health Freedom New Zealand Trust (HFNZ)

January 2016

 

A brief summary and extended discussion of the consequences of the pending Natural Health & Supplementary Products Bill (formerly the Natural Health Products Bill) currently in Parliament.

This is a very complex Bill with many unacceptable aspects. Due to the need for brevity and clarity we have restricted our comments mainly to aspects that will affect consumers.

Summary

  • The third reading of the Natural Health and Supplementary Products Bill is imminent. This Bill will ban most Natural Health Product (NHP) ingredients without just cause.
  • NHPs in NZ are presently regulated under a ‘Black-list’ (a short list of 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 be replaced by a new ‘White-list’ approach, with a very limited ‘White-list’ of ‘permitted ingredients’. Any ingredient that is not on this permitted ‘White-list will not be allowed to be sold in NZ
  • 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.
  • Any NHP ingredient that is recognised as having therapeutic (health improving) effect can be re-classified as a medicine by the MoH. Once it is classed 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 Bill to make allowances for this if it does happen.
  • You can provide feedback to the Government on the Bill, sign a petition on www.Change.org and sign up with HFNZ for updates on this important matter.

Ed note:  The link to the petition is https://www.change.org/p/naturalhealthproducts-moh-govt-nz-keep-access-to-nutrients-in-nz-that-have-a-proven-safety-record-and-therapeutic-benefit

Discussion
The passing of the Natural Health and Supplementary Products Bill will result in many Natural Health Products becoming either severely restricted (via new proposed low dosage limits), or being made outright illegal in NZ.

Consumers will no longer be able to purchase products that they currently use to keep themselves well. Just a few examples that have been sent to us by consumers, of products that they believe will be affected by the Bill are: Lypo-Spheric Vit C, Lypo-Spheric Glutathione, Truehope EMPowerplus, Hardy Nutritionals Daily Essential Nutrients, all 5-HTP products, all Methionine products, Metagenics Azeo-Pangen, MediHerb TyAdren Support, Pure Encapsulations Ascorbyl Palmitate, Go Healthy Go Prostate Protect, Syntol AMD, Douglas Laboratories De-Mer-Tox, Future Formulations Inner Healing. We invite readers to contribute to this list by emailing us at info [at symbol] HealthFreedom.co.nz

 

Natural Health Practitioners will be unable to properly practice as they will no longer be able to prescribe to their patients’ needs.

The Ministry has stated in the consultation document that products made by a practitioner for an individual patient will be exempt from the Bill – including Rongoā Māori and Traditional Chinese Medicine – but that these same products will not be allowed to be sold over the counter.  However New Zealand Health Trust’s interpretation of the Supplementary Order Paper (the most up-to-date version of the Bill) 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 they have stated that most of the detail will be crafted AFTER the Bill has been passed!

Products presently classified as ‘Practitioner Only Range’ will not be exempt from the Bill.

The proposed financing model of the new system presents significant risk to the majority of NZ 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 NZ.

The new regulatory system will be funded by industry on a Full Cost Recovery Basis by annual registration charges on all products. Note that there have never been any registration charges before. These charges will rise as the range of products decreases due to the ‘White-list’ restrictions. Short run products will become economically unviable and thus will be discontinued, forcing smaller operators to close. Every time a manufacturer reduces its product range or closes its doors, the remaining products and remaining manufacturers will have to shoulder more of the financial burden of funding the agency. The biggest players will benefit from this approach, as they can afford the fees – and this approach will increase their market share. This is one reason why large manufacturers support this bill.

Presently in Australia under the TGA it costs manufacturers $40,000 – $150,000 just to apply for one ingredient to be accepted on their White-list, with no guarantee of success. There is little incentive to make an application because, if successful, a manufacturers’ competitors are able to benefit at no cost to them. And as only one or two ingredients per year have ever been passed by the TGA, this discourages manufacturers from even trying. There is no reason to believe that this will not also apply here in NZ should the Bill be passed.

The ‘single ingredient approach’, which is the framework of the Bill, is outdated and misleading for two reasons:

  1. It does not reflect the fact that when ingredients are consumed together, higher doses can be safely tolerated above the consumption of a single ingredient.
  2. If any one ingredient in a product exceeds a specified dose, then the entire product will be outlawed in NZ. Most supplements have multiple ingredients, affecting a huge number of supplements that New Zealanders are already relying on for their health and well-being.

The Bill will allow Medsafe (the business unit of the Ministry of Health) to increase its control over NHPs by the following means:

  • It will reverse the basic historic principle confirming our rights to consume any natural health ingredient that is absent from a short defined ‘Black-list’ of substances where there is robust evidence of harm.
  • The number of ingredients we can currently access is too high to quantify, yet no deaths have been attributed to these ingredients or products (see “No Deaths from Supplements. No Deaths from Minerals. No Deaths from Amino Acids. No Deaths from Herbs” http://orthomolecular.org/resources/omns/v12n02.shtml)
  • Our present system will be replaced by a ‘White-list’ of permitted ingredients and only ingredients on this list will be sold in NZ. Furthermore, many permitted ingredients have severe dosage and application restrictions placed upon them. There is no scientific reasoning or justification for such limitations, and no history of risk to human health.
  • The proposed ‘White-list’ currently contains 5,545 ingredients. This may sound like a lot, but to indicate what this means in terms of what we stand to lose, we only need to add up a small handful of the numerous categories of currently allowed natural ingredients to appreciate the magnitude of loss. There are so far over 8,000 identified Polyphenols, over 3,000 Enzymes and over 12,000 Medicinal Plants. These few examples alone make it easy to see that only a very small fraction of our current range of natural ingredients will remain, should this legislation be enacted.

Permitted Ingredients ‘White-list’ File

It is vitally important for you to check if any ingredients that you presently use in your supplements are not on the permitted list.

Which ingredients do YOU rely on? Check them out here: http://www.medsafe.govt.nz/regulatory/PILSearch.asp

You can search the file by entering the ingredient name. If the ingredient is not on the list at all, then it will not be permitted in over-the-counter products. Also check the maximum permitted daily dose, and whether it will be permitted for internal or external application only.

What the Columns mean
In the ‘Outcome’ column ‘Y’ means ‘Permitted’ (but make sure you check the maximum permitted amount, and the application, e.g. Glutathione (an important antioxidant) is permitted, but only for applying to the skin), ‘N’ means ‘Unaccepted’, ‘U’ means ‘Under Review’. If the ‘Reason’ column states ‘rejected by IJEACCM on safety grounds’ – IJEACCM stands for ‘The Interim Joint Expert Advisory Committee on Complementary Medicines’, a NZ/Australian initiative.

 

What is the background to this Bill?

There has been a de facto pharmaceutical monopoly on medicines for almost 100 years.

 

When we become ill we need medicines. But pharmaceutical medicines are dangerous and can cause substantial harm.

 

The monopoly has endured and grown stronger due to laws that have been passed. There have been many discoveries made over those 100 years that offered safer, cheaper and more effective treatments than the pharmaceutical options, but the regulators have always stepped in to prosecute, confiscate product and even imprison the people who made or used the discovery.

 

Very occasionally the regulators’ attempts to destroy a new discovery are not completely successful, and a natural alternative flourishes for a few years. But the Big Pharma lobbyists respond and it doesn’t take long for new laws to be drafted that strengthen the monopoly and the status quo remains.

 

We can’t prevent Big Pharma and their lobbyists from trying to maintain and strengthen their position. They are very much aware of the impact that an appropriately regulated Natural Health Product industry would have on their market share. They have a duty to their shareholders to prevent natural medicines from entering the market.

 

But our elected MPs need to wake up and stop passing such laws. The Natural Health and Supplementary Products Bill is Pharma-based and hostile to the interests of the consumer and the Natural Health industry.

 

Consumers stand to be the biggest losers if this Bill is passed. There are many importers, manufacturers and re-sellers who do not oppose the bill for fear of retribution, as a lot of the fine print will be decided after it has been passed. They hope to be able to stay in business with reduced ranges and less effective products.

 

Consumers on the other hand, stand to lose access to life saving Natural Health Products. NHPs can save lives in several ways, from helping people to stay well so the need for pharmaceutical intervention doesn’t arise (the death toll from adverse reactions to properly prescribed pharmaceutical medicines is over 100,000 a year in the USA alone) to products that are capable of returning seriously ill people back to good health.

Health Freedom NZ supports the aims and proposed legislative model of the New Zealand Health Trust http://www.nzhealthtrust.co.nz. Their mission is to ensure that the consumer comes first in all health regulation, and that Natural Health should be regulated through a stand-alone regulator, not as a division of a larger pharmaceutical or food regulator. When you run this bill through the NZHT checklist of appropriate regulation it fails on every count http://www.newhealth.co.nz/mission.php

 

 

What Can You Do?

 

This Bill will soon have its third and final reading to become law, and is expected to take effect around June 2016. The Regulations are expected to come into force shortly afterwards. The full regulatory scheme will be phased in over three years after the legislation comes into force.

The consultation document contains a list of 47 questions and a “consultation submission” can be filled out online. However HFNZ recommends that the questions should not be answered because the regime is fundamentally flawed and engaging in the detail implicitly validates this unsuitable regulatory model.

 

For those who have limited time to prepare a submission and wish to oppose the Bill in principle, click the link below for a short pre-prepared submission. We recommend you personalise your submission as much as possible. (Ed note:  The reason for personalising your submission as much as possible is that government committees and agencies take less notice of  template submissions than they do of unique submissions.)
http://www.nzhealthtrust.co.nz/nhp_prepared_submission.html

Editor’s note:  Information to help you write a submission may be found at this link:

Information to help you make a submission on the Natural Health and Supplementary Products Bill

SEND submissions to naturalhealthproducts@moh.govt.nz

 

Should you require additional time to make a submission, you should request an extension of time from the Ministry.

  1. Submissions on the Consultation Document close at 5pm on Friday 5 Feb 2016
    2.      Submissions on the Draft List of Conditions about which a claim can be made & the Draft Permitted List will open on 6 Feb 2016 and close on 31 May 2016.

 

You can make a submission by emailing: naturalhealthproducts@moh.govt.nz

Or by posting your submission to:

Natural Health Products
Ministry of Health
PO Box 5013
Wellington 6145

 

 

  • We invite all consumers who want to be kept informed of developments and / or help to save our right of access to Natural Health ingredients to sign up for the Health Freedom Newsletter.

 

http://www.healthfreedom.co.nz/home/160-subscribe-to-hfnz.html

 

 

AN EXAMPLE OF A SUBMISSION IS BELOW:

To: Natural Health Products, Ministry of Health

Subject:  MY SUBMISSION ON THE CONSULTATION ON THE NATURAL HEALTH BILL

 

 

I refer to the Ministry’s consultation paper “The Regulation of Natural Health Products”.

 

I do not intend to address the detailed questions because I consider that the regime is fundamentally flawed. 

 

I oppose the Natural Health Product Bill and request that it be removed from the Order Paper.

 

 

My reasons for opposing the Bill include:

 

  • The Bill is a loopy law (refer Rules Reduction Taskforce) and nanny-state legislation that imposes significant and unjustified new compliance costs on (what government accepts is) a very low-risk industry.  The current regime regulates natural health products as foods.  The Bill, however, takes a pharmaceutical-type approach to natural health products that is disproportionate to the de minimis risks they pose.

 

  • It is claimed that the Bill is light-handed regulation.  However, for the reasons set out in this submission it is the opposite.

 

  • The Bill creates a new regulator with wide and arbitrary powers.  For example, this regulator has to approve every ingredient that is included in a natural health product, including (bizarrely) even water and simple additives and flavourings.  Unless a product is notified to the regulator (at a proposed annual cost of $195.50 per product) and contains only pre-approved ingredients it can’t be sold.  This is overly prescriptive and completely unnecessary

 

  • The new regulator has to also approve the illnesses and ailments for which health benefit claims can be made.  Even if good evidence exists to support the health benefit claim it can’t be made unless the regulator says so.  This restriction is not necessary because the provisions contained in the Fair Trading Act 1986 against misleading claims provide sufficient protection to consumers.

 

  • The Bill imposes significant new compliance costs on the industry. The cost of getting a new ingredient approved on the permitted substance list is likely to be comparable to the cost of getting a substance listed in Australia (because the criteria appear similar).  In Australia the cost to prepare an application for a new substance is approximately $40,000. These are principally the various consultants’ costs to obtain and prepare the necessary supporting information, including literature searches and toxicological reports.  If there is no toxicological data available, it could cost up to a further $150,000 to obtain that data.  This cost could apply to an everyday food item that has a long history of safe use.

 

  • As well as the cost of obtaining approvals for new substances and new illnesses/ailments, there are numerous additional new compliance costs including: the cost of notifying each product to the regulator, the cost of providing information on a website about any health benefit claims made about a product, the cost of obtaining a license to manufacture natural health products, and the cost to comply with the Code of Manufacturing Practice.

 

  • The Bill is likely to stifle exports. The Bill is being justified on the grounds that it will dramatically increase exports.  However, New Zealand already has a healthy and competitive export market under the current regime and there is no credible evidence as to how exports will be facilitated under the Bill.  To the contrary the Bill is more likely to stifle exports.  All exporters will have to comply with the proposed Bill and only products containing permitted substances (that have also been notified) will be able to be exported.  As a result New Zealand will lose its enviable reputation of being able to provide products with ingredients that other countries want.  And at the same time we will lose our competitiveness because of high compliance costs.

 

  • An exporter has to manufacture and comply with the overseas country’s rules.  New Zealand’s rules are irrelevant. Any claim that exports will be increased under the Bill appears loopy.

 

  • The Bill restricts health benefit claims. Another claimed justification for the Bill is that it will permit health benefit claims to be made.  However, health benefit claims (eg, Form and Function claims) can be made already, including arguably claims about certain illnesses and ailments.  It is not apparent how the Bill makes it easier to make claims or improves the status quo.  But there are many ways that the Bill makes health benefit claims more difficult.  For example:

 

  1. The Bill requires information about all health benefit claims to be available on an internet site.  This is a new obligation and is likely to be onerous.

 

  1. The Bill does not permit therapeutic claims and under the Bill it appears it would not be possible for natural health products to be approved as a related product under the Medicines Act 1981 as they currently can be.

 

  • The Bill is a solution looking for a problem. There is no evident problem with the current regime that requires these draconian measures.

 

  • The solution is a regime based on a blacklist of ingredients. An alternative and viable regime is one administered by the Ministry of Primary Industries that is based on a blacklist of ingredients only.  Ingredients genuinely proved to be unsafe would be banned rather than all ingredients banned until they are proven to be safe.  There is no need for the industry to pay to include everyday foods and ingredients like blueberries and water on a permitted substances list.

 

  • The Bill needs to be removed from the Order Paper. This Bill offers no demonstrable benefits to industry and consumers but only imposes additional costs, bureaucracy and intervention.  The Bill needs to be removed from the Order Paper for the good of the industry (particularly the small to medium enterprises) and consumers.

 

NB: The NZ Journal of Natural Medicine frequently includes articles relating to freedom of choice in healthcare  Our online shop, where you can buy printed and PDF copies of our magazine is here.

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