NZ Skeptics Articles

Background

Craig Shearer - 11 September 2023

The Therapeutic Products Act is the most significant shift in the regulation of medicines, medical devices and natural health products in almost 40 years. It will replace the Medicines Act 1981 and Dietary Supplements Regulations 1985 with a new regulatory regime.

The intention in introducing the Act is to assure the quality and safety of therapeutic products based on the risks and benefits. The Act covers more recent developments and technologies that were not fully covered under previous legislation, including medical devices and cell gene and tissue therapies. The Act brings Natural Health Products and therapies (NHPs) into scope but is not intended to stop people buying them unless there is robust scientific evidence to justify restrictions.

The Act will come into effect by 1 September 2026, and the regulations to support the new Act will be developed by the Ministry of Health in the time leading up to that. Consultation is required as part of that process. Although the Act defines the scope of the regulations, it will be the regulations, and the resourcing behind the processes that support and enforce the regulations; this will determine what the Act means in practice.

The NZ Skeptics Society sought input from our members and made a written submission as part of the consultation process on the Bill. Committee members Bronwyn Rideout and Mark Honeychurch also met with the select committee and gave an oral submission.

Our focus was primarily on Natural Health Products (NHPs). Evidence shows that NHPs are not risk free. Consumers have experienced a range of harms from NHPs – from mild discomfort to severe adverse reactions or dangerous interactions with medicines. Inaccurate or unsubstantiated health claims about NHPs might also delay people seeking treatment for serious conditions that are best treated with evidence-based conventional medicines and therapies. Of course, there’s also the cost of NHPs. Are people just creating expensive pee?

The Ministry of Health commissioned Sapere, a research company, to conduct a rapid literature review on the evidence of harm in relation to NHPs to help support the Health Committee in its consideration of the Bill. The review found that the safety of NHPs is not always guaranteed. The reviewed studies identified adverse events associated with the use of NHPs, particularly in relation to some studies finding that herbal products are associated with liver injury. The incidence of serious adverse events was generally low. However, it is unclear if the low incidence of adverse events is due to their good safety profile or underreporting and limited investigations. The Sapere report is quite short, and makes good reading.

The Health Committee’s report on the Bill and submissions from other political parties can be read here Therapeutic Products Bill The report broadly responds to all the submissions made. I have read this, and the final legislation and summarised the relevant outcomes below.

Potential areas for skeptical activism

I’m putting this bit upfront in case you don’t make it to the end of the article.

The law won’t be in force until 1 September 2026 so our focus for the next three years should be on influencing the direction of the regulation that is being drafted to support the Act. Some areas that will be particularly important will be giving input on the:

It is worth doing the work up front here as it will save a lot of work down the track getting unsafe ingredients, health claims and pharmacopeia out of the system one by one.

Once the new regulations are in force we will be able to continue to raise these issues, and can also tackle misleading statements and the conduct of NHP practitioners. I expect that this will sit alongside some of our existing activism in the advertising standards space.

Outcomes on the areas we made submissions

There were changes made to the Bill before it passed into law. Some key changes were strengthening the control over advertising therapeutic products, including whether direct to consumer advertising could be controlled. There is also an exemption scheme for small scale natural health product manufacturers. Notably, a new section of the Act prevents the restrictions of the Act from applying to rongoā (traditional Māori medicine) practitioners, services and activities.

Market Authorisation

We submitted that NHP products should be proven to work. However, efficacy for NHPs remains outside the scope of the legislation. The final legislation has added the requirement that the applicant must satisfy the regulator about health benefit claims being made (s9). How much impact this change has will depend entirely on how proactively the regulator does these assessments.

In our submission, we took exception to an explanatory note in the Bill that indicated 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.

An NHP meets the criteria for a market authorisation if the Regulator is satisfied on reasonable grounds that the NHP will meet the product standards that apply to it. The Health Committee noted that many NHPs may not have relevant product standards. Therefore, they recommended amending the Bill to refer to any product standards that might apply to an NHP. They also proposed that if the sponsor proposes to make any health benefit claim of the kind referred to in the Act, the NHP would need to meet the criteria in the rules for that claim (s127(1)).

Ultimately it still appears it might be a self-assessment process. But at least there is now the requirement that health benefit claims must meet the rules, which are yet to be developed.

Traditional use and Pharmacopoeias

In our submission we said we were extremely concerned about 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. Instead, health claims should be based on scientific evidence.

Under the original proposed law, a health benefit claim about an NHP may be substantiated by scientific evidence, evidence of traditional use, or both. The Health Committee considered that claims about NHPs should not be permitted if there is no scientific evidence or evidence of traditional use. They have therefore replaced “may” with “must”.

This still leaves us with the “traditional use” loophole and the consequent heavy reliance on the pharmacopoeias to define traditional treatments. There are many pharmacopoeias of varying reliability listing the health benefits of various natural health products and herbs.

The Health Committee said they understand that the pharmacopeia would be developed in regulations that would be consulted on, which is good. They noted that some submitters requested that all evidence from recognised pharmacopeia be accepted. But the Committee said this could be problematic if a recognised pharmacopeia contained statements that recent evidence disputed and the pharmacopeia had not been updated. They state that this acceptance should not apply if there was recent traditional evidence to the contrary for the particular traditional ingredient or product.

This has resulted in some small improvements in the final legislation with regards to pharmacopoeias. The final text now states that “Information about the traditional use of a product or ingredient that is in a pharmacopeia listed in the regulations is sufficient evidence of that use unless there is evidence to the contrary.” There have been two good positive changes here. Firstly, Prima facie (meaning “we will take you word for it”) evidence has been replaced with “sufficient” evidence. There is also the addition of the final words which allow evidence to be provided to the contrary (s62(6)).

It is worrying that it still hinges on traditional evidence around use, rather than scientific evidence around efficacy, but at least we should still be able to argue harm if we can prove it.

We don’t know what NHP ingredients will be allowed. But can assume the pharmacopeia will be leaned on heavily in this regard as they have been in Australia. The Ministry does not have a specific list of prohibited or restricted herbal ingredients, although some herbal ingredients are restricted under the Medicines Act for safety reasons (eg, Atropa belladonna and Datura species). A list of recognised NHP ingredients will be developed as part of the regulation to support the Act. It should be noted that there was an old draft Permitted Substances list for NHPs from 2013 to 2017, which was not finalised and never used. It is now of historical note only and has no legal standing.

Rongoā

A new section has been added to the Act since the Bill was proposed to recognise and respect the Crown’s obligations to give effect to the principles of te Tiriti o Waitangi/the Treaty of Waitangi in relation to rongoā. An NHP is a rongoā product if it is manufactured by a rongoā practitioner and intended for use in a rongoā service or activity. It doesn’t matter whether the practitioner is paid (in with money or in kind). Someone who works for a rongoā practitioner or who is involved in any way in delivering a rongoā service or activity provided by a rongoā practitioner is an associate of a rongoā practitioner.

Rongoā practitioners essentially have sovereignty over their own practice as far as NHPs go and will be responsible for self-regulating these activities as far as they see fit. It is unlikely there will be much ability to interfere except where there is evidence of significant safety risks.

One area to watch will be whether we start to see non-Māori practices trying to adopt the rongoā label or have themselves recognised as rongoā practitioners or associates.

Removal of Health Benefit claims

We said 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.

This is an “ambulance at the bottom of the cliff” approach, but interestingly the Health Committee goes further and looks at heading off these health benefit claims at registration. They said in their review that they understand that the details for a business to substantiate health benefit claims itself using scientific evidence would also be set in the rules. This is news to us, but very encouraging. The committee suggested an amendment, which has been made, to enable businesses to substantiate a relationship between an NHP, or NHP ingredient, against a pre-approved list of health benefits and qualifiers that are set out in rules. The rules would also set out any requirements for self-substantiation (s63).

So, I think we need to watch this space in terms of what the rules for establishing health benefit claims for NHPs might look like.

Covert advertising

We submitted that verbal statements should be covered in the advertising rules.

The law defines an advertisement as any communication made for the purpose of promoting a product (s194). Communication includes “a communication made in any way whatsoever (including, for example, by an individual in person, using a physical object, in print, or using any kind of information or communications technology).”

The Health Committee Report makes some interesting comment relevant to our submission about “astroturfing”:

A number of submitters raised concerns about these provisions [on advertising]. The submitters considered that the definitions were too broad and confusing and they were unsure how they would be applied. They were concerned that the definition could extend to a range of communications. They might include patient appeals for fundraising, advocacy activities, satire, research, news reporting, protest and industrial action, and public discussion. We were advised that clauses 193 and 194 [now renumbered] are intended to prevent the promotion of therapeutic products in New Zealand that do not have an NZ authorisation. They are not intended to capture occasions when therapeutic products are mentioned but are not promoted. We think amendments to the bill are needed to indicate the types of communications that are not intended to be captured. We recommend amending clause 194 to specify that a communication that was exempted under the regulations could be a communication that involved unauthorised therapeutic products. “Astroturfing” means disguising a professionally orchestrated public relations or marketing campaign by presenting it as having arisen from unsolicited public comments or grass-roots support. To mitigate the risk of astroturfing, we recommend amending the bill to enable regulations to be made under clauses 193(3)(f) or 194(g). The regulations we envisage would require a person to disclose any funding or in-kind support received from the sponsor, manufacturer, or supplier of the therapeutic product that was being communicated or advertised.

As an outcome of this 197(1)(c) Adds the ability to regulate how advertising is distributed and 197(2)(f) states that advertising ‘must not contain misleading information’ to prevent ‘astroturfing’.

Direct to consumer advertising

We also asked that direct advertising of prescription medicines to consumers be prohibited.

There are no restrictions on direct-to-consumer advertising in the new law, but regulations can be made about the form of the advertisement, how it is distributed and who it is distributed to under s197(5)(a). This may prohibit advertising of a specified class of therapeutic products to a specified class of person or in specified circumstances. The intention of this is to cover what we have suggested, but it needs to be supported in the regulations when they are drafted.

Fast track takedowns

We suggested that there be a fast-track process to remove dodgy therapeutic products while they were investigated. The Act hasn’t been changed from what was proposed in the Bill in this regard, but s206 does introduce a post-market surveillance and response.

By law the Regulator must have in place a post-market surveillance and response system for all therapeutic products that have a market authorisation or that are otherwise lawfully in the supply chain (other than rongoā products that do not have a market authorisation).

For NHPs the regulator is required to conduct surveillance of the safety and quality (but not efficacy).

A moratorium order can be made to temporarily restrict a therapeutic product on safety grounds while it is properly evaluated. It takes effect on the day after it is published on the regulatory website. It will have an expiry date and won’t run longer than 12 months.

Moratorium orders can be made if the regulator suspects that the product does either or both of the following:

  1. directly or indirectly exposes any individual to a risk of death, serious injury, or serious illness:

  2. creates or increases a significant risk to personal health or public health; and

are satisfied on reasonable grounds that it is necessary or desirable to impose a moratorium on the product, having regard to—

  1. the likely benefits of, and risks associated with, the product; and

  2. the purpose of a product moratorium order in subsection (3).

There are special powers in the Act to allow the regulator to require information to be provided, to require samples and testing and to enter premises. They can issue recall orders and premise restriction orders for safety reasons. They can issue an advertising remediation order to retrieve the advertisement from distribution, destroy it, distribute a retraction, remove it from an internet site under the person’s control.

So I guess the question again is, how proactive will this regulation be?

Submission topics where no changes were made in the legislation

There were a number of submissions we made that have had no traction.

Other key points of note

Market Authorisation is not required for some important/exports/supply

A new clause has been added to allow some activities without market authorisation:

9(6) This Act allows some products to be imported, supplied, or exported without them having a market authorisation (for example, medicines that require compounding, custom-made devices, and low-concentration NHPs).

Small-scale NHP manufacturers do not need market authorisation

You heard that right, small-scale NHP manufacturers will not need to obtain a product authorisation or manufacturing licence from the new regulator where their products are made and supplied in-person to customers in New Zealand. Product authorisation would still be required for imported NHPs. This is consistent with the treatment of other products under this legislation, such as low concentration NHPs, or those made by a practitioner as part of a consultation for a client. This is disappointing.

“Professional body” was too vague.

The definition of “professional body” has been deleted and replaced with “practitioner regulatory body”. The term “professional body” is commonly used to refer to a much wider range of bodies that represent various groups of health professionals and these groups are not intended to be included under the legislation.

Food

16(3) now excludes food as defined in the Food Act 2014, including foods that are NHPs. However, regulations can be made under 16(1) declaring something to be a therapeutic product regardless of whether it is a “food”.

Exemption from register if market authorisation not yet approved but product already being supplied in New Zealand.

Clause 378(2)(a) specifies that the register would need to include all therapeutic products for which an application for a market authorisation had been made but not yet determined. It would also need to include therapeutic products for which a market authorisation had been refused.

The Health Committee Report commented that several submitters expressed concern that a requirement to publish when a market authorisation had been applied for but not yet determined could have implications for commercial confidentiality. They also noted that the requirement to include products for which a market authorisation had been refused could also have implications for potential sponsors. Consequently, sponsors could choose not to proceed with an application or to delay submission, limiting the choice of or timely access to medical devices for New Zealanders.

s378 has been amended with an exemption from register if market authorisation not yet approved but product already being supplied in New Zealand.

Penalties

Penalties and fines reworked throughout the Act to have more consistency in outcome.

Transitional Provisions (Schedule 1)

  1. A product that was a consented medicine but is now an NHP is deemed to be a medicine.

(12) Temporary market authorisation is created for all NHPs that immediately before commencement, were lawfully being imported into, supplied in, or exported from New Zealand in the course of a business or undertaking – but excluding low concentration NHPs. It permits the sponsor to make the health benefit claims about it that were lawfully being made immediately before commencement. Expires 2 years after commencement.