Barbara Roberts, Homeopath

Therapeutic Products Act

If you have not already heard, the Therapeutic Products Bill passed its third reading last week on Wednesday. 

It really feels as if this legislation was rushed through – the Select Committee normally gets 6 months to work on a bill, for this they had 3 months, and the third reading was only 3 weeks after the second reading. 

This blog is also preliminary as only the second reading version and supplementary order papers have been published as I write this, but from all my reading and discussions with colleagues this is my current understanding. 

Let’s talk about what the Act will mean when it is implemented in 2026:

All therapeutic products are covered by this – including medicines, active pharmaceutical ingredients, natural health products and medical devices including diagnostic technology.

It is the first time cell phone diagnostic technology will be regulated – and we don’t know how this will impact the apps that we use. For example, many girls and women track their periods on the cell phone – as part of this it predicts their cycle including their fertile period and ovulation. This could be considered diagnostic, and it is not clear whether these apps will then require regulatory oversight under this Act. 

There was a lot of concern that foods with a therapeutic use would be regulated or restricted under this act – however they have clarified that things usually considered a food, such as spices, will continue to be regulated under the Foods Act. 

Rongoa Maori has been exempted – Clause 110A allows Rongoa practitioners to use any rongoa remedy even if not registered, to dispense for other practitioners’ clients and for other practitioners – all the things that we wanted for all Natural Health practitioners. 

Despite all the Homeopaths asking for changes on clause 31 which prohibits remedies from human origin, or animal origin from an animal named in the rules, there was no change to this. Even with our education about the method of potentiation so there is no measurable particles in these remedies, they are prohibited. The particular wording is in 31 (1) An NHP is a low-concentration NHP if (c) it does not contain anything of human origin; and (d) it does not contain anything that is, or is derived from, an animal or part of an animal set out in the rules. 

For Homeopaths this will restrict our Matridonal remedies (made from things like breast milk, amniotic fluid and umbilical cord), and some of our nosodes (remedies made from diseases, like Morbillinum from measles). 

Unlike Rongoa practitioners, under clause 112 we also must have a consultation to make a personal recommendation, so we are unable to dispense for clients of other practitioners, and cannot dispense for each other. We also will not be able to post remedies to overseas clients who are not normally resident in New Zealand. 

As it currently stands there will not be changes to supplements that are currently available. All supplements currently on the New Zealand market will have interim approval for up to two years. In addition our small scale producers – those who make ointments and tinctures and sell on a small scale have been exempted. 

However, once this is implemented there will be increased costs, and some companies may decide the red-tape is not worthwhile for the small market (on a global scale) that we represent. There will be costs for the Ministry of Health to set up the office of the Regulator and their staff – and while we currently have MedSafe, by adding these extra areas of regulation there will be more needed. Once the Act is implemented, all costs of regulation, including audits will be levied and paid for by industry – which means that products will increase in cost. 

They have reduced the penalties for making an “impermissible health benefit claim” about an NHP to a mere 1 year in prison and/or $100,000 fine, or a fine not exceeding $500,000 (clause 252). However the select committee did add section 312A and 312B which are defences relating to misrepresentation about a therapeutic product (312A) or relating to advertising (312B), which state it is a defence if the defendant acted in good faith for reporting news or a matter of public concern, research, study, or education, criticism or review of the therapeutic product, fundraising for the acquisition for a specified individual or individuals, or for advocating for a change in Government policy about therapeutic products. 

Part 9 of the Act is about the Regulator, who is appointed by the Chief Executive of the Ministry of Health. They can still rely on reports, assessments or decisions by overseas regulators or organisations (clause 346). Before regulations are made – the part we are all now waiting for – the Regulator must (380 (3) (a) ) consult the persons (or representatives of the persons) who the Regulator thinks are likely to be substantially affected by the instrument, and (b) give them the opportunity to comment. Unfortunately, as we know, the opportunity to comment does not mean they will listen or implement anything we suggest.

Schedule 1 states that anything that is currently a medicine will stay a medicine, and Natural Health products will have a temporary market authorisation that will expire 2 years after commencement. Note – low-concentration natural health products, aka homeopathic remedies, do not require a market authorisation, but those of human origin are still not permitted. 

So – where to from here:

If you use homeopathic remedies at home as a consumer, you will not be affected by the restriction of these homeopathic remedies of human or animal origin. For practitioners, we will notice it, but there will be alternate remedies we can use, and alternate methods of dispensing these remedies that allows us to practice within the legislation.

As a Homeopath, I am not going anywhere, and the other Homeopaths and Naturopaths I know are the same. We are here for the long haul and will make things work within the legislation. Students and those who hope to study can also be assured that you are not only needed as a practitioner, but will be able to practice effectively even with any restrictions. Those of us with more experience will be here to help you navigate this path. 

What you can do: 

There will be a petition coming out from the Homeopathic Society shortly, so please keep an eye out for that, sign it and share it far and wide.

Talk to your MPs and those standing for your electorate. Act and National both stated that they opposed the bill in the Select committee report, we need to make sure we are asking them to repeal the Act or remove Natural Health Products from the Act. Some of the minor parties have stated that they will repeal the Act, but this would be in conjunction with the major parties, so make sure you are discussing it with everyone.

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