What is the Therapeutic Products Bill?

The New Zealand government has introduced the “Therapeutic Products Bill,” which will control how products that appear to benefit health are manufactured, prescribed, imported, advertised, supplied, and exported.

The government describes this bill as:

“intended to replace the Medicines Act 1981 and the Dietary Supplements Regulations 1985 to provide for the comprehensive, risk-proportionate regulation of therapeutic products, such as medicines, medical devices, natural health products, and active pharmaceutical ingredients.”

According to Health Minister Andrew Little:

“It will enable New Zealand to take advantage of advances in medicine, such as cell and tissue therapies, emerging gene therapies, and the use of artificial intelligence and machine learning software. Having risk-proportionate approval systems will improve access to necessary and life-saving medicines, such as vaccines in a pandemic.”

Natural Health Products (NHPs) are set to be regulated alongside gene therapies and experimental vaccines.

TLDR: The government is proposing to include Natural Health Products (NHPs) in a new Bill seeking to regulate natural ingredients and compounds alongside pharmaceutical products such as gene therapies and experimental vaccines. If included, this will impact the availability of NHPs and remove the ability for Kiwis to make their own healthcare choices with respect to natural medicines and products.

Find our more…

Watch this 8-minute clip from our recent webinar on the topic & share it in your networks.

Watch our latest webinar session with pharmacist and homeopath, Barbara Roberts. The session dives deeper into the actual wording of the TPB and how it will impact consumers, patients, manufacturers, and service providers.

Watch the entire session with Dr. Guy Hatchard on the Therapeutic Products Bill below.

Another Broken Promise

Documents released under the Official Information Act reveal that a government paper recommended that NHPs remain out of the Therapeutic Products legislation. During meetings across the country, officials promised that Natural Health Products would not be included in the proposed law.

The inclusion of Natural Health Products in the Therapeutic Products Bill is yet another broken promise by Labour.

The following sections from this 2018 government paper clearly show that the advice was to keep NHPs out of the Therapeutic Products legislation.

So, why the change in direction?

Regulating Natural Health Products

An important part of the bill aims to regulate the natural health products used by more than 50% of our population.

This is the third attempt in recent years to introduce extreme regulation of the public’s healthcare choices, specifically natural products. Earlier attempts failed because of vocal public opposition.

In 2017, Labour collated a list of 300 common herbal ingredients that they planned to prohibit.  The latest version of the proposed legislation omits such a list. We are left to assume that the previously published lists will form a basis for this new legislation if passed.

One could also argue this omission is deliberate and leaves the door open for the government to add whatever they like to the list once the bill has passed. We probably don’t have to spell out how opaque and dangerous that is.

Why are we concerned?

Why the NZ public must demand that natural health products are removed from this Bill:

  • This is a critically important piece of legislation going through parliament. Every single person who uses natural health products in the country will be affected (whether that’s someone who sees a natural health professional, someone who pays attention to their health and likes to use supplements, or just a layperson with little idea about health but who likes to pick up a fish oil or vitamin C at the supermarket occasionally).
  • It will place the power to make decisions over what products we can access as consumers and as health professionals into the hands of one man (or woman), who is unlikely to have any actual knowledge of natural health products, and will be independent-but-not-actually-independent (quote “the regulator will be a public servant appointed by the Director-General of Health on the basis of their relevant knowledge and expertise. The Regulator will exercise their powers under the Bill independently of the Director General of Health and the Minister of Health, but may be subject to general policy directions issued by the Minister”). Does that sound independent to you?
  • There is no justification for including low-risk natural health products in this legislation. It isn’t appropriate, it isn’t necessary, it isn’t risk-proportionate, and it is utterly illogical. The thought that one person can hold so much power over what products we wish to use without truly understanding what they are or how they work is unthinkable.
  • NHPs are significantly safer than the other medicines and products regulated alongside them. That isn’t to say they are risk-free, but the risks are far, far lower than with pharmaceutical medicine. Many adverse effects involve polypharmacy, incorrect use, or adulterated product (which is an issue, but that doesn’t mean we need govt interference to remedy it!).
  • The Bill is very, very vague. There are no clear definitions for what constitutes a natural health practitioner or traditional medicine and traditional practice (Western herbalism, rongoa Maori, TCM, Ayurveda, and other traditional medicine systems should all be included in that, but the question is – will they be?). Nor are there any assurances that qualified members of the natural health community will be on the advisory panels, as they should be if this goes ahead.
  • Much of the Bill is predicated on lists and rules that haven’t yet been published – making it very difficult to assess what’s happening. All we have is previous lists from earlier attempts at the Bill, and what is on them is very limiting and very concerning.
  • There will be a list of allowable products and ingredients, and we stand to lose access to many of our best herbs and supplements under this legislation – even some foods – at the whim of one person. There is an entire section dedicated to removing any animal or human-derived ‘low concentration natural health products’ (homeopathic), which will mean homeopaths will lose access to a significant portion of their materia medica and nosodes. We don’t have the herbal medicine list at this stage, but based on prior attempts, we know that a significant number will almost certainly be included.
  • If an ingredient is not approved, then any products based on that will be gone. For example, if lecithin is banned for internal use in supplements, as Dr. Guy Hatchard points out happened in the 2016 legislation, anything including it will be gone too, including liposomal forms of supplements.
  • Dosage limits are likely to be affected, with therapeutic dosing on nutrients made very difficult unless prescribed. We already have much lower levels available of a number of these, such as vitamin D3, and it will likely be made lower still, meaning therapeutic effects will be harder to attain and maintain.
  • Oftentimes, people turn to natural health practitioners and products after the mainstream medical system has failed them and no longer has solutions to their problems. This law will further remove choices for people seeking alternatives to mainstream options.
  • Natural health practitioners’ tongues will be tied and free speech gone as their ability to tell you about the healing properties of virtually anything is under threat – if they make a therapeutic claim (or even imply that something may assist, such as garlic lowering heart disease risk) that hasn’t been approved on a list that has yet to be printed, as a practitioner they face a $200,000 fine and/or up to five years in prison.
  • The way natural health practitioners practice will also be limited. They can still dispense herbs and products to you – but only in the context of proper consultation. They can’t pre-pour formulas. They can’t dispense for other practitioners in other towns. Dispensaries will be hugely affected, and their ability to help you will be greatly hindered. If you live overseas and aren’t normally resident here, they can no longer send you anything. This will hugely affect their clinics and our ability to support you.
  • The enormous costs of registering products and the red tape in getting them to market will spell the end for many small to medium-sized natural health businesses. The compliance costs with this Bill will push many out of business and make it unattainable for all but the biggest to operate.
  • This is government overreach at its worst. The idea that a government-appointed regulator can control the activities of dozens of complementary medicine practitioners is beyond absurd. Each complementary healthcare system has its own internal standards, which have proved quite sufficient for decades, if not hundreds of years, in some cases.

What you can DO about it…

VFF strongly believes in the ability of Kiwis to have autonomy over their diet, health, and medical decisions. This includes unrestricted access to natural foods, herbs, and medicines that have been safely used for thousands of years.

If you value this too, it is essential that your voice is heard on this matter.

Our success in removing Natural Health Products from the Therapeutic Products Bill depends on you. This is a numbers game. If the government receives overwhelming opposition to the inclusion of NHPs in the legislation, especially during an election year, they will be more likely to remove them.

In addition to making a submission, you may like to sign this petition opposing the inclusion of NHPs in the Therapeutic Products Bill.

You can also write to all the MPs, a template email with all their email addresses and suggested wording is available here.

The new closing date for submissions is 11.59pm Sunday, 5 March 2023

Submissions /Objections Template

We urge you to make your submission to the proposed legislation here and share this page with like-minded friends and family so that they may do the same.

VFF’s legal team has provided a submission template for you to use as a basis to oppose this bill. The advice is to keep your objection brief and to the point.

You may choose to include points from the Why are we concerned? section above.

You may also wish to email your local MP about this issue, outlining why you think NHPs should be removed from this Bill. Check back in a few days for a template letter to send to your MP, the PM, and the Health Minister.

Information regarding submissions on the Therapeutic Products Bill

  1. The government is calling for submissions on the Therapeutic Products Bill, which it introduced late last year. Those submissions close 11.59 pm Sunday, 5 March 2023.

  2. The Bill:

    a. is intended to replace the Medicines Act 1981 and the Dietary Supplements Regulations 1985 to regulate therapeutic products, such as medicines, medical devices, natural health products, and active pharmaceutical ingredients.

    b. Introduces a new regulator within the Ministry of Health, headed by an independent statutory officer, with a wider remit than the medicines regulator Medsafe.

  3. For more information, you can review:

    a. the consultation information here and other Ministry of Health documents relating to the regulatory regime are here

    b. the Therapeutic Products Bill is here

    c. commentary in parliament on the Bill is here and here

    d. the Ministry of Health is required to prepare a disclosure statement to assist with the scrutiny of this Bill – the statement seeks to bring together in one place a range of information to support and enhance the Parliamentary and public scrutiny of that Bill and is available here.

  4. We encourage you to either prepare and file a submission with the Health Select Committee, which you can prepare and:

    a. submit here

    b. if you are having difficulties submitting your submission as per 4.a, then you can email it to the Health Select Committee secretariat at [email protected]

  5. We encourage you to either prepare and file a submission with the Health Select Committee, which you can do utilising the template below.

  6. Here are some blogs that may be informative:

    1. https://www.thelookingglass.co.nz/therapeutic-products-bill-labyrinthine-unaccountable-as-it-exits-the-starting-gate/

    2. https://hatchardreport.com/natural-products-regulation-an-overreach-of-government-control/

    3. https://youtu.be/TEqEhjthTSU

    4. https://homeopathbarbara.com/health-and-homeopathy-blog/

Submissions on the Therapeutic Products Bill [TEMPLATE]

[DD/MM/2023]

  1. The Bill proposes:

    1. to replace the Medicines Act 1981 and the Dietary Supplements Regulations 1985 to regulate therapeutic products, such as medicines, medical devices, natural health products, and active pharmaceutical ingredients;

    2. introduces a new regulator within the Ministry of Health, headed by an independent statutory officer, with a wider remit than the medicines regulator Medsafe.

  2. I oppose the Bill including natural health products in the Bill.

  3. I also oppose….

    1. [list]

    2. [expand where you feel necessary]

  4. I wish / do not wish to be heard on these submissions.

[Name]

[Contact details if you wish to be heard]

[Date]