The New Zealand Skeptics Society is a non-profit body that exists to promote critical thinking. We are frequently contacted by the media to provide informed comments on science and pseudoscience, and support evidence-based policymaking. We offer public education on rational thinking, helping people to understand the gap between proven ideas and nonsense. We think that one of the most important jobs MPs have is to protect the citizens of New Zealand from the harm caused by unproven products and services.
We are generally pleased with the direction of the Bill and its attempt to update the Medicines Act and regulate Natural Health Products. It will be a positive step to have a comprehensive set of rules that help to ensure that medicines, medical devices and Natural Health Products are safe for New Zealanders to consume.
However, we consider that some important changes will be required if the proposed legislation is to achieve its intended purpose, which is to provide an appropriate level of assurance that products imported and supplied within New Zealand are both safe and effective.
Our proposed changes are as follows:
Explanatory Note Part 4, Issuing Market authorisation for NHPs
The statement that market authorisations for NHPs differ from the provisions relating to medicines “to reflect the fact that the risks associated with NHPs are generally less than the risks associated with medicines” should be removed, as this is an unsubstantiated claim. There is no evidence given to support this statement, and it gives a misleading impression that NHPs are safer than scientifically tested and controlled medicines and devices, whereas in reality we know that many natural health products sold in New Zealand have been prepared with ingredients that are dangerous, including homeopathic nosodes (“containing” diseases such as HIV, tuberculosis and typhoid), black salve, colloidal silver, spider venom, digitalis and much more.
4.a Proportionate risk
We are concerned that only immediate risk may be considered when evaluating Natural Health products. We see many NHP practitioners make claims that their product is a panacea that is able to cure all ills. These kinds of claims carry a long-term risk of erosion of the public’s health literacy, and are likely to lead to people believing that NHPs are efficacious, and consequently trusting these practitioners when it comes to serious health issues like cancer. Sadly, even in a country as small as New Zealand, we have regular news stories about people who have died from treatable diseases because they have trusted their Natural Health practitioner.
See our comment on Section 122 for more details about this issue of false assumptions about the safety of NHPs.
9.3.c Market authorisation of NHPs
We do not understand why there would be a different rule for NHPs from medicines and medical devices – surely any therapeutic product should be able to prove its efficacy or performance. NHP practitioners talk about how their products can help treat medical conditions, so why shouldn’t they have to show efficacy? This issue is repeated throughout the legislation.
10.2 Controlled Activities
We think that surveys (e.g. “92% of respondents reported that their skin looked healthier after using our cream”) should also be subject to appropriate regulations, and be added to this list. This should ensure that people’s subjective opinions and the outcomes of poor questionnaire methodology or data sampling are not presented as facts, and therefore would protect against misleading both the public and regulators.
11.1 Who can carry on a Controlled Activity
NHP practitioners of different modalities have a wide range of both education and regulation, with many having little to none of either – and certificates often being able to be purchased over the internet. With this lack of standardised and robust control over their practice, it seems imprudent to give them the ability to carry on controlled activities in the same way as health professionals such as pharmacists, doctors and veterinarians.
We are also concerned that here, and in other parts of this legislation, “health practitioners” are allowed to carry on controlled activities. Although most health practitioners are evidence-based, and medically trained, the HPCA Act 2003 also includes chiropractors and osteopaths as “health practitioners”. Neither of those are evidence-based practices, and are widely considered by medical professionals to be pseudoscience.
12.3 Restrictions on advertising NHPs
We are very happy to see, in principle, that there will be a prohibition on giving false or misleading information about NHPs, although we are concerned that the details of the legislation in this Bill don’t actually support this.
13. Efficacy of NHPs
We are extremely concerned that, unlike efficacy for medicines and performance for medical devices, there is no requirement for NHPs to show that they are effective at treating anything.
We think that, at the very least, information about any proven effectiveness of Natural Health Products should be collected alongside safety and quality information – even if this list does not match the list of allowed claims. This will ensure that health professionals will know which of the allowed claims are backed by scientific evidence, and which are not.
However, we would ideally like to see NHPs treated like any other health product, where claims of their efficacy can only be made where there is robust evidence to substantiate the claims. To do anything less than this does a huge disservice to a public who are trusting this legislation to protect them.
Simply put, if efficacy does not have to be shown for NHPs, we believe people shouldn’t be allowed to make any therapeutic claims about them. If NHPs are omitted from a requirement to have their efficacy proven, they shouldn’t be able to subsequently make claims of efficacy. If, when they obtain market authorisation, they can show efficacy in being able to treat certain medical conditions, only then should those conditions be added to their allowable health claims list for advertising. Allowing NHPs to skip the requirement to give evidence of their efficacy, but then allowing them to make claims of efficacy in their advertising, is a case of letting them have their cake and eat it too – and it’s obvious this is not in the best interests of consumers.
We’re sure that NHP sellers will be able to advertise their products effectively without needing to make unsupported therapeutic claims about them. We already see practitioners using vague words and phrases like “supports”, “promotes” and “winter ills and chills” to avoid falling afoul of the current Medicines Act regulations. Ensuring that nobody can make unsupported claims about NHPs under the new legislation will just mean that Natural Health practitioners will continue to use this kind of advertising to make the same empty promises they are already making. There is no need to weaken the law for these products, especially when this weakening would come at the expense of the public’s health and safety.
We are concerned that some NHP practitioners could use an NHP product’s inclusion in this list in their marketing material and elsewhere to imply that the product is effective. We think that it should be made clear in the Bill that inclusion of an NHP in the scheme does not equate to the product having any health benefits, and we would like to see inclusion of a clause outlawing the use of this list in this manner.
18. Naturally Occurring Things
We think that this section needs to also cover naturally occurring things that haven’t been changed from their naturally occurring state, if the person selling them for a therapeutic purpose has not made any changes to them.
30.3 (a) Antioxidants
Although we understand that antioxidants are generally used as a preservative, we are concerned that therapeutic claims are often made about antioxidants, and so they’re often treated by advertising as more than just an “additive”. We’re not sure if they belong in the NHP ingredient list in (1), but they seem like a special case that might not fit (3) as well as the others do.
31. Homeopathic Products (Low Concentration NHPs)
We consider that Low Concentration NHPs (better known as homeopathic treatments), or any other NHP that is administered, packaged or prescribed in a manner akin to the way a medicine is packaged, administered or prescribed, should be required to have market authorisation, and should not be removed from the scheme due to having “sufficiently low risk”. This would allow for control of the risk of harm from contaminants, as well as mitigate failure to seek conventional treatment and minimise financial harm.
57.1.b.vi NHPs for Animals
We see no reason why administration of medicines (1,b,v) and use of medical devices (1.b.vii) on an animal are covered in this section, but not administration of NHPs to animals (1.b.vi). We think that for consistency, and to provide adequate protection for our furever friends, animals should be covered by 1.a.vi.
61.4 Traditional Use
We are extremely concerned in this part of the legislation by the inclusion of “traditional use” as a supposed method of substantiation of a health claim. Historical or traditional use of a health product, “natural” or otherwise, is most definitely not evidence of efficacy and should not be considered substantiation. Many ineffective or dangerous natural health products have been used by NHP practitioners in the past, and continue to be used today. Considering historical use as a form of substantiation is a type of logical fallacy, usually called the “appeal to antiquity”.
In an ideal world consumer protection should take precedence over the desires of NHP practitioners. We would expect that NHPs, like all other medical products, would need to have evidence of efficacy before anyone was able to make health claims about them. On the face of it, it seems outrageous that any New Zealand legislation would consider allowing people to make health claims about a product that were not backed by robust scientific evidence. Medical practitioners all over New Zealand are concerned about the increase in use of NHPs in our country, and this legislation is likely to worsen the problem.
However we understand that, sadly, we don’t live in an ideal world where laws are always there to protect consumers from harm. Therefore, if this idea of traditional use remains in this piece of legislation, we would like to see the word “substantiated” removed from this section. It seems disingenuous at best to claim that evidence of historical or traditional use substantiates any kind of health claim. Scientific evidence can substantiate a health claim, as the scientific method seeks to uncover the truth. But traditional use only tells us that people have believed in the past that the product may work, and bears little relation to the truth of whether it actually works.
We think that “traditional use” needs to be adequately defined in this legislation, and should only include NHP that have been used for many decades, and where there are no known direct harms from the history of its use.
Pharmacopoeias usually contain thousands of medical products and their uses. Some of these, such as many countries’ national pharmacopoeia, are evidence-based and medically accurate. But others, especially those that deal with NHPs (such as the Pharmacopoeia of the People’s Republic of China and others), are not evidence-based, and contain listings of thousands of natural treatments that are either ineffective or dangerous.
We notice that nowhere in the regulation does it mention which pharmacopoeias will be included, and we are understandably concerned about the possibility of the defunct Natural Health Product Bill’s pharmacopoeias being included in this legislation, as most of them (with the exception of the British, European and United States Pharmacopoeia) are not based in science. For reference, the pharmacopoeias that we consider to be an issue, and are concerned may be included in this legislation, are the:
- American Herbal Pharmacopoeia
- Ayurvedic Pharmacopoeia of India
- British Herbal Pharmacopoeia
- European Scientific Cooperative on Phytomedicines (ESCOP)
- German Commission E Monographs
- Indian Herbal Pharmacopoeia
- Pharmacopoeia of the People’s Republic of China
- United States Pharmacopeia and National Formulary
- World Health Organisation Monographs on Selected Medicinal Plants
If any of these unscientific pharmacopoeias are to be used, we would expect at the very least that there are tight controls over which products from them are included, with products excluded if they are considered to be dangerous, removed if they are later found to be dangerous, and no new products added without a thorough vetting process for their safety.
62.4 Removal of Health Benefit Claims
We would like to see the inclusion of the ability for anyone in New Zealand to apply to the Regulator to have a health benefit claim removed from the allowed list for an NHP, if evidence shows that the product is ineffective, misleading or dangerous.
112. Personalised NHPs
Allowing an exception to these regulations for personalised NHPs, when the regulations are written to ensure our safety, appears to be a dangerous loophole. If the point of this legislation is to protect people from ineffective and potentially harmful health products, that’s what this Bill should do, without any exceptions. This new legislation is a good opportunity to be able to increase the protections available to consumers.
112.5 Who is an NHP Practitioner
Part 5.a of section 112 appears to allow anyone to be considered an NHP practitioner just by selling an NHP to a consumer. These non-regulated practitioners could avoid these regulations all together simply by mixing a custom NHP formula for a consumer. If this legislation is meant to protect people, it should do that effectively. We would like to see regulation around who can call themselves an NHP practitioner, through professional bodies, like there currently is for medical professionals.
124. Market Authorisation of NHPs
The current proposed Bill and explanatory note make it clear the intention is that applications for market authorisations for NHPs would be automated, and lodged through an online portal with applicants making a declaration that the criteria for an authorisation are met, and that the applicant’s declaration that the criteria for an authorisation are met is prima facie evidence of that fact. This will undoubtedly allow products that do not meet the criteria, including those that are unsafe, to go to market and leave the onus on individuals and consumer protection organisations to point out any issues and go through a time-consuming process before they can be removed.
Given the extensive history of NHP practitioners making unsubstantiated, often fanciful, claims about their products, we think that section 124 of this Bill should be modified to ensure that all market authorisations for NHPs are manually screened, and the veracity of the information provided in applications should be tested. We believe that trained medical scientists would be the correct people to perform this screening, rather than individuals from within any particular NHP discipline.
193.2 What is an Advertisement
We are happy to see that the definition of advertisement in this section includes websites, social media posts and other online media formats.
Overall this section is positive, and offers a good level of protection for consumers (with the obvious issue that the list of permitted health claims for NHPs is not robust enough to ensure that the public is not misled about the efficacy of an NHP).
From experience, we know that NHP practitioners are often happy to verbally make unsupported claims about the efficacy of their products/services, even if they never make these claims in written material. It appears likely that this practice will continue under this new law. We would be keen to see the addition of a section of this legislation that covered any claims made verbally about an NHP in a similar way to how section 194 does for advertising.
We also think that this new legislation would be the ideal time to prohibit direct advertising of prescription medicines to consumers, as it currently is in most countries worldwide. It has been an embarrassment to New Zealand for many years now that we are one of very few countries that allows direct advertising of medicines to consumers, although so far any efforts to fix this issue have not been fruitful.
192-199. Fast Track
We believe that this legislation should provide a fast-track method for handling reports of:
- unauthorised health benefit claims (section 192)
- general misrepresentation (section 190)
- misrepresentation as someone allowed to perform an activity (section 191)
- providing misleading or incorrect information to the regulator (section 199)
- advertising without market authorisation (section 193)
This fast-track process should require a temporary suspension of these activities within a short time (such as 7 days), pending an investigation, where clear evidence of a breach has been provided. If such conduct has occurred, it would likely be very difficult for the regulator to establish breaches, except where these are brought to their attention. We think that potentially unsafe products should be removed from the market without delay, and this would in turn disincentivise any person wishing to deliberately subvert these regulations for profit.
We applaud the inclusion of infringement provisions in this Bill, and look forward to seeing their proactive use.
We think that consultation with only “people likely to be affected” by these rules is not broad enough, and this should be explicitly extended to all New Zealanders. This will ensure that important rules such as the allowed health benefit claims for NHPs receive sufficient input from the public.