Therapeutic Products Bill

There's a new bill being introduced to parliament that is intended to replace our Medicines Act 1981 and the Dietary Supplements Regulations 1985. The bill is the Therapeutic Products Bill (TPB) and it's currently at Select Committee stage, meaning that the public is able to provide submissions on it (currently 30 days left as this is published). This presents a rare opportunity to provide input on legislation directly linked to our interests as a society, and we are unlikely to be involved in a legislative change of this magnitude encompassing therapeutic products again for quite some time.

This is an important bill for skeptics as it covers natural health products, which most will know have a pretty dismal reputation proof of efficacy, and are the mainstay of the so-called alternative medicine (SCAM) industry.

NZ Skeptics will be making a submission on the bill, but we'd encourage individual skeptics to submit individually as it's likely that more voices making similar points will have sway with the select committee. You can find details on the bill on the parliament website. From time to time they do ask submitters to front up and speak briefly to their submissions, so if you have some expertise in this field let us know, as we appreciate all the help we can get.

The bill's purpose is to provide an appropriate level of assurance that products imported and supplied in New Zealand are safe or made to the appropriate quality standards. It also puts in place a framework to regulate health benefit claims made about natural health products. The target date for the legislation to come into force is 1 September 2026.

As you would expect, the Bill covers medicines, medical devices, natural health products, and active pharmaceutical ingredients. The natural health products covered include traditional and herbal medicines, and vitamin and mineral supplements. Interestingly, the medical devices also include software, and will include some mobile device apps that use accelerometers or heart rate measures to diagnose. Medicines also include biologics (including microorganisms, viruses and bacteria) or anything synthesised to have the same effect. This seems likely to encompass gut health cultures and pills. So, in summary, the Bill covers anything used to prevent, diagnose, monitor, alleviate, treat, cure, or compensate for a disease, ailment, defect, or injury. It also covers products involved in the maintenance of health and supplementation.

The Bill takes a life cycle approach to regulation, meaning all the suppliers, handlers, manufacturers involved in bringing a therapeutic product to fruition will need to comply with certain rules along the way.

The Bill requires that all therapeutic products receive market authorisation from the regulator before they are imported into, exported from, or supplied in New Zealand, and there are significant penalties for non-compliance (up to 5 years imprisonment or $200K for individuals or $2M for organisations). The Bill also provides for the regulation of a range of controlled activities, for example manufacturing, export and clinical trials. While advertising is not a controlled activity, the Bill allows the regulator to impose restrictions on advertising of therapeutic products.

That all sounds pretty good, but it's the details where the loopholes creep in, and I have noticed a few. We have a unique opportunity right now to try to squash a few of these bugs before it gets passed. Although the Bill is supposed to be reviewed every 5 years, realistically it could be decades before we get a redo on the details of this one.

From the new bill's explanatory note (emphasis mine):

“This regulatory arrangement does not provide an appropriate level of assurance that products imported and supplied in New Zealand are safe or made to the appropriate quality standards. It also does not adequately regulate health benefit claims made about natural health products.

New Zealand's exporters also suffer from the lack of a modern and flexible regime.”

According to the purpose of the bill, it's intended to protect, promote and improve the health of all New Zealanders by providing for the:

• acceptable safety, quality, and efficacy or performance of medicines, medical devices, and active pharmaceutical ingredients across their life-cycle; and
• acceptable safety and quality of natural health products across their life-cycle.

Do you notice the difference there? It would appear that natural health products will be held to a different standard - there's no mention of efficacy or performance! But maybe I'm getting ahead of things here.

The bill recognises that therapeutic products provide benefits, but are not risk free. It identifies risks including contamination or counterfeiting, and that products can be affected by improper supply or administration or use by unqualified people. (Though my snarky reaction to this would be that some alternative health practitioners are qualified, but that their qualifications are somewhat dubious!)

The bill also provides for open and well-functioning markets, and that the legislation should be compatible with international standards and dovetail with work by overseas regulators. I guess it's attempting to strike a balanced path which would allow for manufacturers to develop innovative products and export them - something which is reportedly difficult currently.

For a good overview of the bill, it contains a relatively short Explanatory Note, which sets out its purpose and gives a summary of the main points.

Our new committee member, Katrina has had a look at the bill and has the following comments:

• The Therapeutic Products Regulator will only collect and monitor the efficacy of medicines, not Natural Health Products (NHPs) For NHPs they will only collect information on safety and quality. This is self-report information which is assumed to be correct.

• A product can be removed from the scheme if the Minister is satisfied that it is of sufficiently low risk that regulating it is not necessary, or that it would be adequately regulated by other means (e.g. the Food Act).

  The issue here is that if the product does nothing - so the only harm is indirect (failure to treat) or maybe financial – then perhaps it can avoid the scheme. It may put the provider in a weird position where they need to prove their product is ineffective. Or they may simply hold up their default inclusion as ‘proof' that their product is not inert. Albeit it could just be that nobody has applied to remove it.

  I am also unsure where this leaves homeopathy given the legislation is clearly aiming to include it and has specific reference to low concentration NHPs with concentrations of less than 20 parts per million which require no market authorisation. It feels like this is fence-sitting to me.

• Clinical trial rules don't cover collection of information where the product or device is not used on participants. Surveys are open season. So, I guess the 90% of dentists recommending this toothpaste, or 75% of people plagued with oily skin are still with us to stay.
• You can't get around the health benefit rules by re-categorising the medicine as an ‘active ingredient' instead. Active ingredients are wholesale only. Good.
• The Regulator may only include a health benefit claim in the rules if satisfied that the claim is substantiated. The claim may be substantiated by scientific evidence, or evidence of traditional use. The inclusion of ‘traditional use' seems to be a giant loophole to me.
• NHPs cannot be administered by injection or infusion in any other way other than via the mouth. Good to know.
• There is a requirement to consult ‘people likely to be affected' on the detail of the rules following the legislation. I'm curious as to how this consultation will occur and I think our feedback should be that it includes the opportunity for wider public submissions such as our own.
• There is a clause included that allows an NHP practitioner to supply a product that does not have market authorisation if they can trot out a plausible story that their NHP is ‘customised' to the patient and the practitioner has determined that it is appropriate for the client. I'm just envisioning some sort of tick box survey on ordering, and someone dropping in ingredients based on the outputs.
• The requirements for 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” – I find this assertion very questionable. Surely taking a scientifically tested medicine in the appropriate manner is safer than taking untested products. Sure, many of them might do nothing much, but some might be a bit deadly. How could we possibly know this?
• It is intended that the applications for market authorisations for NHPs be automated and lodged through an online portal with applicants making a declaration that the criteria for an authorisation are met. Making a false declaration is an offence, but the applicant's declaration that the criteria for an authorisation are met is prima facie evidence of that fact. That's legal speak for ‘we'll take their word for it'. The Regulator can request further information or reject the application if there are grounds for doing so. But I'm guessing someone needs to point out the problem first. That could keep us quite busy. Also remember, there is no requirement to establish the efficacy of the product. So, it seems there would need to be evidence of harm or that they have provided false information.
• A person can't make a misrepresentation about a therapeutic product. This includes representing that something is a therapeutic product when it is not. I think proving ‘misrepresentation' could be a bit tricky given they are not required to prove efficacy.
• A person can't misrepresent themselves or someone else to be a sponsor, licensee, permit holder, or someone who is allowed to lawfully do another activity under the Bill.
• The sponsor of an NHP can't make a health benefit claim about the NHP that is not a permitted claim. The clause also applies to the manufacturer, importer, or exporter of an NHP that does not have a market authorisation. I think they would be unlikely to know this has occurred unless someone told them.
• A person can't advertise a therapeutic product unless it has the appropriate market authorisation and complies with the advertising and distribution requirements. If they do, the Regulator may make an advertising remediation order to prevent continued or further distribution of the advertisement or reduce the risk posed by it. Again, it seems to rely on someone bringing it to their attention so it could go on a while before it is stopped.
• Advertising for a therapeutic product is any communication made for the purpose of promoting the product and can be made in any way whatsoever – for example by a person (influencer), in print, or via technology.
• A person cannot include misleading information in a record required under the Bill or alter a record to make it misleading. Misleading information means information that is false, that is misleading in a material particular, or that is misleading because of the omission of a material particular.
• A person can't give misleading information to the Regulator or an inspector.
• Certain information on a label on a package is presumed to be correct unless the contrary is proved. If a package is labelled in a way that identifies a person as having carried out a supply chain activity with the package or its contents, the person is presumed to have carried out that activity. Really?
• There will be a publicly available register of all therapeutic products, licences, and permits for us to request under the Official Information Act. This is good.
• The Minister is to review the operation of the Bill at least every 5 years. The results of the review must be made publicly available and be presented to the House of Representatives.

So, thanks to Katrina for poring over the bill and commenting on it. On the whole, it seems to be a major step in the right direction, but there are potential loopholes that might let some undesirable stuff through.

Over the Tasman they have their Therapeutic Goods Administration (TGA) which is responsible for regulating therapeutic goods, including natural health products. Compared to what we've had the past in Aotearoa/New Zealand, it would seem that skeptics have had more success against dodgy products under that regime. Over here, it seems that only the most egregious and dangerous products will see any action by Medsafe (Black Salve, a corrosive agent which can literally make body parts fall off, is one such example - specifically, Medsafe has issued a warning against that product.)

Skeptics have had more success using the Advertising Standard Authority (ASA) complaint process to pull up advertisers of dodgy products that we have had with Medsafe. (To be fair though, it does appear that Medsafe is pretty under-resourced.)

Anyway, I'm hopeful that the TPB will bring us closer to the sort of experience they've had in Australia with the TGA, but as I said earlier, it's important that we express our thoughts on the bill, with the hope that it can be strengthened further to protect consumers against ineffective and/or dangerous alternative medicine products and therapies.

Listener article

Late last year, The Listener (December 10th - 16th) published an article (as its cover story) “Natural Selection - are plant-based remedies finally coming into their own?” It's tempting to dismiss the article with reference to Betteridge's law of headlines (Any headline that ends in a question mark can be answered by the word no) but I think it's worthwhile to digest the article and respond to its points. It's a fairly major article, with 5 pages devoted to it.

While it's encouraging to see The Listener reporting on this important issue and bringing it to wider attention, as is usual with these sorts of articles, it's very friendly towards alternative medicine and natural health products. It spends a lot of time with Sandra Clair, a Dunedin-based “plant medicine expert” who also happens to be the founder of a business with a range of natural health therapies. I'm guessing that she would certainly be in favour of her own products.

The article notes that many medicines are derived from what were once natural therapies - which is correct. Once a therapy is backed by scientific evidence then it can become a medicine. That doesn't mean all natural therapies are as good as medicines. In fact if the evidence isn't there, they are probably not as good, and they don't have the same safety controls. As we often say, alternative medicine shown to work is just called medicine!

The article references homeopathy, which immediately gives away the bias. We know that homeopathy does not and cannot work (at least when prepared as dilutions of a supposedly active ingredient), despite the protestations of homeopaths.

The article incorrectly states that the legislation will check Natural Health Products (NHPs) are effective - which as we've stated above - will only ask about safety and quality for NHPs. And, the market authorisation process for NHPs will be an automated process and the information provided by those applying will be treated as correct. The article reinforces our concerns that it will be used to legitimise unproven products.

They seem to be under the impression that this will open the door to them making health benefit claims that are currently shut down by our existing laws. The bill allows ‘listed' health benefits for NHPs to be allowed and people can apply to include more. These will be developed as part of the regulations which will follow the legislation so we can't know what they are, but could look to the Australian model to see how that has played out. No evidence of efficacy is required, so it's difficult to see how any health benefit could be included in such a list. It seems likely we might copy something from another country. We can also expect manufacturers and distributors to apply to have their products' health benefits included, which will mean the content is likely to be influenced by commercial interests.

Towards the end of the article, the commercial interests become clear. As I mentioned earlier, there are barriers for manufacturers from being able to export existing products to the rest of the world, and make health claims. The bill proposes improvements to that process. But this does feel like an end run around safety and efficacy requirements in order to satisfy a commercial imperative. We've seen enough potentially dubious products being brought to market without adequate demonstrations of efficacy, but the article thinks it's good that manufacturers will be able to export these products to the rest of the world.