My name is Keith Garratt. I make this submission as a concerned member of the public.
In general, I applaud the intent of creating greater control and certainty regarding products referred to as “natural health products”. However, there are some features of the Bill that are unsatisfactory or disturbing, and which have the potential to detract from achieving its objectives.
In considering this legislation and its purpose, I believe that the following points are important:
- As stated by Hon. Jonathan Coleman in introducing the Bill, the need is for a scheme “that gives the public an assurance that the natural health products they use are true to label and can provide the health benefits claimed for them.”
- By definition, the products which are the target of this legislation have not to date been shown by proper controlled scientific testing to have a proven therapeutic benefit or a medical effect. If they had, they would be defined as medicines and be subject to the Medicines Act.
- Regulation is necessary because there is no doubt that there are many companies and people who either in good faith or knowingly are marketing and supplying products that do not provide a health benefit.
- Unfortunately, there is a proportion of unscrupulous operators and suppliers within the natural health products industry who target unwell, desperate and vulnerable people with false hopes of health benefits, and who must be captured by this legislation.
- If all natural health providers were already operating in good faith and providing accurate information to consumers, the need for this legislation would not have arisen.
2. CLAUSE 5 – INTERPRETATION
The definition of “health benefit” is very puzzling. It includes “(b) nutritional support” and “(c) vitamin or mineral supplementation” as health benefits. These are not health benefits in themselves, but merely possible means to achieve a health benefit. In fact, many medical experts suggest that dietary, vitamin and mineral supplements are unnecessary to good health if a normal balanced diet is consumed.
Also, the inclusion of “nutritional support” is confusing and contradictory, given that Section 6 specifically excludes food from the ambit of the Bill, and the definition of “food” in Section 5 specifically mentions “any ingredient or nutrient” and appears to clearly include dietary supplements. It is hard to conceive how nutritional support can be offered without the use of food.
(d) lists “affecting or maintaining the structure or function of the body” as a health benefit. This seems ludicrous. If I drink a pint a day of whiskey (a natural product) for a long period, I will certainly affect the structure and function of my liver to the point where I will die.
Can I suggest that (b), (c) and (d) be deleted. Clauses (a) and (e) provide an adequate definition of “health benefit” for the purposes of the Bill.
3. CLAUSE 6 – DEFINITION OF NATURAL HEALTH PRODUCT
This is the key section of the Bill, but contains several areas of concern. In particular, I believe it needs strengthening to ensure that some of the most concerning elements of the natural health products industry are captured by the requirements of the Bill.
3.1 INTENT OR CLAIM OF HEALTH BENEFIT ?
6(1)(a)(ii) defines a natural health product as one that is intended by the sponsor to bring about a health benefit. The problem I see here is that the very people who should be the prime target of the legislation, the charlatans who knowingly tout useless quack medicines, have no intention of providing a health benefit, but only of relieving gullible and vulnerable people of hard-earned cash. The clause needs to be amended to clarify that it is a claim to provide a health benefit that is important, not an intention. It would be most unfortunate if a charlatan could escape the severe penalties in this Bill simply by admitting that there was never any intention to provide a health benefit.
There is some contradiction as to whether homeopathic products are to be captured by the legislation. The preamble notes to the Bill state that natural health products include homeopathic remedies. However, I note from Hansard that Sue Kedgely stated that “low-risk products like homeopathy products will be exempt“. I believe that they must be included. While I agree that they pose a low physical risk, they do pose serious risks in other ways. Homeopathic products are displayed, marketed and often verbally promoted by staff in many pharmacies, providing them with credibility, and encouraging people to rely on them rather than conventional medicine. The website www.whatstheharm.net documents many cases worldwide where people have suffered or died through reliance on homeopathic treatments.
The definition of natural health products currently in the Bill may not capture homeopathic products. Homeopathic products are prepared by sequential 1:100 dilution of the original substance, routinely up to 30 iterations (referred to by homeopaths as potencies). In a press release on 30 January 2010, Mary Glaisyer, Media spokesperson for the New Zealand Council of Homeopaths, admitted that “In homeopathic remedies above the 12th potency no molecule of the material substance remains.” (maryglaisyer.com/2010/01/press-release-mass-overdose). Homeopaths claim that, despite this, the water used retains a “memory” of the original substance. The credibility of this claim is of course highly debatable, but for the purposes of the Bill the simple fact is that homeopathic remedies do not in fact contain the original substances in any material way. This means that homeopathic remedies contain no natural health product ingredients and are therefore not captured by the current definition. Again, this seems to leave open the possibility of a technical defence in court.
The definition therefore needs amendment to clarify that homeopathic products are captured.
3.3 PRESENTATION AND MARKETING
A feature of the natural healing sector is that products are often presented or marketed in a manner that skirts around the requirements of fair trading and truth in advertising requirements by vague and misleading implications of efficacy. Also, as mentioned above regarding homeopathy, natural health products are widely displayed and marketed in pharmacies without specific or actionable claims of therapeutic properties, but in a manner that in many cases gives a false credibility and a false impression of efficacy.
3.4 SUGGESTED AMENDMENTS TO CLAUSE 6
To address these three issues, I propose that Clause 6 be amended along the following lines:
- Amend (1)(a) to “that is claimed by the sponsor of the product to bring about a health benefit to the person to whom the product is administered.”
- Delete (1)(a)(ii) and renumber the remainder of (a) as (b), with subsequent amendments to the numbering of later clauses (b), (c) and (d).
- In the present (b), insert after “contains only natural health product ingredients” “or is prepared by dilution of one or more natural health product ingredients”.
- Add a new clause (1)(f): “that is presented, promoted, located or displayed in such a manner that any person might reasonably infer that it is intended to provide a health benefit.”
4. SECTION 10 – NATURAL HEALTH PRODUCTS ADVISORY COMMITTEE
The implication of 10(4) is that the members of the advisory committee will be natural health products practitioners or producers. This is somewhat akin to having an advisory committee on drug abuse made up of drug producers and sellers. Given that we are dealing here with public health, it would seem important that the committee includes people with the scientific and medical skills required to objectively assess the efficacy of products and the accuracy of any claims for their health benefits.
It would appear that an effective and efficient solution that would reduce duplication and achieve greater consistency would be to extend the functions of the Medicines Classification Committee established under Clause 9 of the Medicines Act.
5. SECTION 13 – PRODUCT NOTIFICATION and evidence
13(3)(b)(ii) requires the sponsor to hold evidence to support the health benefit claims made for the product. This is good, but 13(8)(b) provides that this can be “evidence based on traditional use of a substance or product”. This is very concerning, and brief consideration demonstrates that it is in fact ridiculous. If we look only in Western culture, we can find many examples of traditional uses that have been discarded in the light of modern knowledge. In my own childhood, the traditional treatment for burns was butter, and traditional treatments for wounds were mercurochrome or pure iodine. These are all now recognized as ineffective and potentially harmful.
Up until about 100 years ago, laudanum was the traditional treatment for many ailments, and available without prescription. This was a tincture of opium equivalent to high doses of morphine, and was addictive. As the active ingredient was produced from poppies, laudanum would qualify as a natural health product under the provisions of this Bill.
There would be a major problem in defining what is meant by “traditional use”. A brief glance at an Oxford Dictionary reveals that “tradition” has various shades of meaning.
Evidence based on traditional use is clearly inappropriate, and I urge that section 13(8)(b) is deleted, and that the Bill should specify that the only acceptable evidence for efficacy is double-blinded placebo-controlled scientific research.
I should note also that alternative health providers frequently provide anecdotal accounts as supposed evidence of efficacy. This is also unacceptable. The body is a self-healing mechanism, so there will always be examples of apparent cures that are in fact not a result of treatment, whether alternative or conventional.
6. CLAUSE 6(1) AND 6(3)
Taken together, these clauses appear to have the effect of excluding substances to be administered intravenously or to eyes or ears from the definition of “natural health product”. This is presumably in recognition that such administration of unproven substances in these ways is dangerous. However, I fear that these clauses as worded could be interpreted to exempt such substances from registration and regulation rather than to provide greater restriction on their use. If those clauses are removed, they would need to prove effectiveness and safety in the same manner as any other substances. Alternatively, a clause such as follow may be appropriate:
“Nothing in this Act or its administration is to be construed to permit the manufacture, sale or administration of substances to be administered by injection or parenteral infusion or to the eyes and ears.”
7. CLAUSE 13
Clause 13(6)(a) exempts from notification a product that is prepared by a practitioner for a particular person. This seems illogical. I believe such products are less likely to be prepared under controlled conditions and less likely to be of proven effectiveness. As an example, I have a friend who some years ago acquired a severe auto-immune disorder. She recovered under conventional medical treatment, but now spends many hundreds of dollars a year on a herbal concoction prepared by a backyard practitioner, with no evidence that it has any beneficial effect.
The basic objectives of the Bill are commendable. However, I believe that there are some concerning anomalies, contradictions, weaknesses and potential loopholes that need to be rectified if it is to properly meet its objectives. The amendments that I have proposed are designed to achieve that.
9 February 2012