It's all about the NHPs

The proposed Therapeutic Products Bill is currently at the Select Committee stage in parliament, and the committee is looking for feedback via its submissions process. For the first time maybe since the repealed Quackery Prevention Act of 1908, this legislation will attempt to police “alternative medicine”. Almost everything about regulating Natural Health Products (abbreviated to NHPs in this legislation) is new territory. The main issue with this bill, at least from our reading of it, seems to be that the government considers evidence of historical use of an NHP treatment for a condition to be “substantiation” of any health claims about it. So, basically, if a natural health product has been used in the past for treating a medical condition, whether it actually helps or not, the government will just assume that it is effective. This, to my mind, is reckless and dangerous.

Why should there be two tiers of health products? Why do medicines have to provide evidence that they are able to treat a particular medical condition, but natural health products only need to prove that they've been used in the past in an attempt to treat a medical condition? Surely we need to protect consumers against misleading health claims, whether those claims are for medicines, herbs, diluted flowers, vitamins, prayers or a machine with fancy looking dials and knobs. It seems like it would be simpler, more consistent, and fairer to just treat all health products the same, with the same requirements for substantiation. We now have modern science to help us figure out what works and what doesn't, so why should we make special allowances for archaic (and sometimes not even old) unproven health products?

A major concern is that any list of permitted health claims that natural health products can make is going to look like an endorsement of those claims - and this is going to be a bad thing. Natural health practitioners will doubtless point to a list of allowed claims as evidence of efficacy, no matter how much the government might say that their list should not be taken as such. And that is likely to mean that consumers end up being fooled into trusting in natural health products for their healthcare needs. The last thing we need is people trusting a naturopath, acupuncturist, homeopath or chiropractor to advise them on their health.

Sadly the reality of the situation is that, as part of the government's regulation of NHPs, they're going to let naturopaths and others make daft health claims about these products. I'm not sure how this legislation could best be edited to make sure that consumers are safe from snake oil salesmen and saleswomen, but I am sure that it has the potential to be a backward step if it's not focused on the consumer rather than the practitioner and their business. The devil is in the detail, as they say. We would love for as many of you as possible to let the select committee know what you think about the bill - as Daniel has already told you, there are already a lot of submissions that argue (badly) that NHPs shouldn't be regulated at all. The more we can do to counteract that by sending in reasoned submissions congratulating the effort to regulate NHPs, while pointing out the issue with the bill's flaws, the more likely it is that the select committee doesn't chicken out and remove NHPs from the bill all together.

When it comes to figuring out where this bill has issues, and what you should give the select committee feedback about, the quickest and simplest thing you can do is to search for the phrase “NHP”. There are a couple of ways you do this in your browser - either click Control-F when reading the Whole Bill, or type “NHP” in the Search box at the top of the bill's page to see three pages of Search results. There'll be a whole bunch of results (265 to be exact), but they're bunched in just 73 clauses out of the bill's total of 423. Some of them will be irrelevant, so skip to the meaty ones and have a read of what they are proposing.

Some pointers

To help, here are a few sections/clauses (the bill seems to use these terms interchangeably) that seem to be concerning, along with my thoughts on what some of the issues with them might be:

9. Market authorisation

The process for getting a market authorisation is set out in Part 4. In broad terms, an applicant must satisfy the Regulator—

  1. in the case of a medicine, about its safety, quality, and efficacy:
  2. in the case of a medical device, about its safety, quality, and performance:
  3. in the case of an NHP, about its safety and quality.

13. Administration of regulatory scheme

The Regulator carries out surveillance of therapeutic products with a market authorisation (or that are otherwise lawfully in the supply chain) to collect and evaluate information about—

  1. the safety, quality, and efficacy of medicines; and
  2. the safety, quality, and performance of medical devices; and
  3. the safety and quality of NHPs.

For both of the above sections (and others), there's no requirement for NHPs to show efficacy. Why wouldn't NHPs have to show they work, just like any other medical product. After all, the people who sell these products act like they're medicines, so ideally they should be treated the same - it seems pretty bad to allow some people to make health claims about their products without having to back up their claims, and force everyone else to provide evidence.

67. Market authorisation required to import, supply, or export

  1. A person must not—
  2. import or supply a medicine or medical device unless it has a NZ authorisation; or
  3. export a medicine or medical device unless it has a market authorisation; or
  4. in the course of a business or undertaking, import or supply an NHP unless it has a NZ authorisation; or
  5. in the course of a business or undertaking, export an NHP unless it has a market authorisation.
  6. However, the person may do so without the product having the requisite authorisation if—
  7. a licence, permit, or provision of subpart 3 allows the person to do so; or
  8. the product is a low concentration NHP.

Low concentrations NHPs, more commonly known as homeopathic products, appear to get an exclusion. However, although they usually don't have much in the way of active ingredient, they should still be subject to the regulations in this legislation around safety, efficacy and allowed claims.

57. Supply chain activity and person in the supply chain

  1. Each of the following is a supply chain activity:
  2. a controlled activity:
  3. doing any of the following in the course of a business or undertaking and in circumstances that do not constitute carrying on a controlled activity:
  4. importing a therapeutic product:
  5. exporting a therapeutic product:
  6. supplying a therapeutic product:
  7. being in possession of a therapeutic product:
  8. administering a medicine to a person or an animal:
  9. administering an NHP to a person:
  10. using a medical device on a person or an animal.

Why aren't NHPs given to animals covered in this section? It seems like an oversight at best.

61. Health benefit claim, permitted health benefit claim, and substantiating claims

  1. A claim about an NHP is a health benefit claim if it states or implies that the product is beneficial for a therapeutic purpose.
  2. A permitted health benefit claim for an NHP with a market authorisation means—
  3. a standard health benefit claim for the NHP identified in the market authorisation; or
  4. a custom health benefit claim set out in the market authorisation.
  5. A permitted health benefit claim for an NHP that does not have a market authorisation means a standard health benefit claim for the NHP.

Substantiation of health benefit claim

  1. A health benefit claim about an NHP may be substantiated by scientific evidence, evidence of traditional use, or both.
  2. Information about the traditional use of a product or ingredient that is in a pharmacopeia listed in the regulations is prima facie evidence of that use.

There are a couple of issues here - firstly, “evidence of traditional use” is not a good way to substantiate efficacy. Secondly the pharmacopoeia are mentioned but never listed. This list may potentially contain some unscientific documents, as the now dead Natural Health Products bill had planned to do.

112. Personalised NHPs

  1. This section applies for the purposes of sections 67 and 69(1) and (2)(d)(i) and (ii).
  2. An NHP practitioner is allowed to manufacture an NHP that does not have a NZ authorisation if—
  3. a person (the client) consults the practitioner about the client's health needs; and
  4. the consultation is carried out in accordance with any consultation requirements in the rules; and
  5. the practitioner determines that the NHP is appropriate to address the client's health needs; and
  6. the practitioner manufactures a quantity of the NHP for the client; and
  7. Either—
  8. the NHP ingredients in the product are all recognised NHP ingredients; or
  9. the NHP is a low concentration NHP; and
  10. the product meets the product standards that apply to it; and
  11. the practitioner complies with any other requirements in the rules about manufacturing the NHP.
  12. The NHP practitioner is allowed to supply the NHP if—
  13. they supply it to the client by non-wholesale supply; and
  14. they comply with any requirements in the rules about that supply.
  15. The NHP practitioner is allowed to export the NHP to the client if—
  16. the client is ordinarily resident in New Zealand; and
  17. the NHP practitioner complies with any requirements in the rules about that export.
  18. In this section, NHP practitioner means an individual (regardless of the title or description they use) who—
  19. carries on a business or undertaking of providing personal consultations with clients to identify the client's health needs and to supply by non-wholesale supply or to administer NHPs to address those needs; or
  20. the rules say is an NHP practitioner.

There are a couple of obvious issues we can see here. Firstly, personalised (one-off) natural health products seem to get a free pass. And secondly, the definition of NHP practitioner appears to be anyone who sells an NHP! Surely there should be some regulation around this.

193/194. Advertising

I won't add the legislation here, but it might be good to write something supporting these sections, as they appear to be pro-consumer and thorough.

Don't delay, act today

It would be great if some of you are able to submit something to the select committee about this bill, even if it's just a pat on the back for the government at least attempting to regulate Natural Health Products. Your submission doesn't have to be long, but given Dan's documenting of many people's ranting responses, it's probably good to make it logical, polite and free of spelling mistakes! As well as our combined society submission, our chair, Craig, has already written a personal submission - and I'll be following suit in the next few days. We've chosen not to share our full submission text, so that none of you copy our exact wording, but I've tried to summarise some of our key concerns above. Feel free to base your submission on anything I've written above, or, as we joked about on our podcast, feed what I've written to ChatGPT and get it to write a submission for you. However you do it, once it's done you can enter your submission here:

https://www.parliament.nz/en/pb/sc/make-a-submission/document/53SCHE_SCF_BILL_130084/therapeutic-products-bill

As a bonus for anyone who manages to write a skeptically inclined submission, if you come along to one of the Society for Science Based Healthcare's regular Activism meetings in Wellington, the Society will shout you a free beer for your effort!