Therapeutic Products Bill NZ
I am sharing what I know so far -thanks to the wonderful people in my industry who have already teamed up to get some sort of clarity what this means for us all.
To read the full summary and how it might affect you too please see shared post on Facebook - and LINK IN instagram BIO - for submission link.
“If you use homeopathy, herbs or supplements and want to continue to have the freedom of choice for modalities and practitioners and the choice of herbs, supplements and remedies, if you want to be able to support micro and small businesses and individual practitioners then PLEASE read this post, or the bill itself and make a submission. You can just pick out one thing that resonates with you, and the write something in your own words about what it would mean for you, why you are concerned. There are no spelling or grammar checks and it is not marked, but your individual voice is important. “ - Barbara Roberts Homeopath.
Here is an example of a submission you feel free to share , edit, copy , use parts of etc thank you to Carl Meyer for writing this to share.
Dear Members of Parliament,
I am writing to express my strong objection and concerns regarding the 2023 New Zealand Therapeutics Bill currently open for public input. Here are my main points:
- For millions of years, globally, humans and animals have maintained their health naturally by eating the fruits, foods, and herbs of the earth.
- This bill's classification of natural health products and herbs as alike to pharmaceutical controlled medicines is deeply concerning, and has the potential to restrict the availability of essential foods, herbs and important natural products for millions of New Zealanders.
- The bill requires the appointment of a regulator who will have the power to decide for all New Zealanders what natural products can be sold openly and what should be restricted. The idea that one organisation can decide for all of us what plants that grow in the earth can be sold, eaten, or used, is an unjustified interference to our freedoms as Kiwis.
- The bill will restrict the use of plants that are used to make a medicine, or if the molecular structure of any of its compounds is mimicked by a medicine. This will result in a significant reduction in the availability of natural health products, and will leave many New Zealanders with limited options for maintaining and improving our health. 80% of drugs are in fact derived from the properties of plants.
- The situation at the border is also concerning, as herbs that benefit health may be classified as medicines and therefore cannot be imported except with a permit. This would lead to border officials examining packages and potentially discarding anything deemed healthy.
- There is absolutely no need for the Government to regulate natural foods based on DNA that are used in natural health products. Natural foods and herbs should automatically be excluded from regulation. This bill threatens to undermine the health and wellbeing of the 50% of New Zealand citizens who currently use natural products for our health and wellbeing.
- The bill will also place additional financial burdens on manufacturers and end users, raise the cost of natural health products, and introduce uncertainty about products that have been relied upon by many New Zealanders.
- The bill proposes a short consultation period that spans the summer break, which is seen as an underhanded move to disperse public interest.
- The bill also refers to a list of common herbs planned to be banned under a 2016 bill, which would greatly disrupt the availability of traditional remedies relied upon by many New Zealanders, particularly those from Indian and Chinese traditional medicine systems which have been proven safe and effective internationally.
- There is no evidence that the public is being disadvantaged or harmed by natural products under current regulations and therefore, there is no need for additional regulation.
The Therapeutics Bill in its current form is clear Government overreach. I urge you to reconsider the provisions of this bill and to prioritise the freedom of all Kiwis to take care of their health naturally with herbs and foods that have been safely and effectively used for millennia.
here is more information about the bill so you can read to know an in depth summary:
Therapeutics Products Bill
At the end of 2022, this Bill was introduced to Parliament and had its first reading.
It is not the first time that there has been proposed legislation for Natural Health Products, and the current legislation it proposed to replace - the Medicines Act and the Dietary Supplements Regulations - arguably need updating. But there are a large number of areas that are problematic for users and practitioners of a wide range of complementary health modalities. Even medicines and medical devices will be impacted, and costs will increase particularly for medical devices, even if you are just replacing parts.
If you use homeopathy, herbs or supplements and want to continue to have the freedom of choice for modalities and practitioners and the choice of herbs, supplements and remedies, if you want to be able to support micro and small businesses and individual practitioners then PLEASE read this post, or the bill itself and make a submission. You can just pick out one thing that resonates with you, and the write something in your own words about what it would mean for you, why you are concerned. There are no spelling or grammar checks and it is not marked, but your individual voice is important.
The Bill is huge, and it is incorporating the Medicines Act, with Medicines, Medical devices and Active Pharmaceutical Ingredients, as well as Natural Health Products (NHPs).
Let’s start at the beginning -
Clause 30 defines what NHP ingredients are. As a Homeopath this does not directly impact my practice, but if you use locally sourced herbal products grown from a micro business, this clause defines them as a NHP which has implications further on in the bill. It includes plant and non-human animal extracts, vitamins, minerals, amino acids and ingredients to formulate these. Under this clause placenta capsules, made from your own placenta after birth would not be possible.
Clause 31 is a biggie for Homeopathy. It is about low concentration NHPs which includes homeopathic products and tissue salts. Homeobotanicals and flower essences would fall under clauses 29-30 as they are not dilute enough to be considered low concentration. The biggest issue here is 31 (1) (c) and (d) which say that a low concentration NHP cannot contain anything of human origin or from an animal covered in the rules (sheep and cows). This will make our Matridonal remedies - Lac Humanum, Lac Maternum, Vernix, Amniotic Fluid, and Placenta Humanum unavailable. It will mean that we cannot use our old nosodes - Tuberculinum Bov which is from cattle, and any nosodes that are made from diseased human tissue, or discharges, like Carcinosin, or Psorinum would not be available either. These are such important remedies that make up a large part of my practice and are so effective. They are remedies that can be used for recurring illnesses, for inherited predispositions to disease (miasmatic influences) and when other indicated remedies are not working as well as they should.
If you are writing about this clause in the submission then ask for all homeopathic remedies or low concentration NHPs with a concentration less than 1x10*23 are exempt because there is no risk of disease from them.
Clause 69 makes manufacturing, or exporting NHPs and importing a low concentration NHP a controlled activity - that is prohibited unless allowed by license. You want to send some Kawakawa balm to your cousin in Australia? Nope, can’t happen as that would be exporting an NHP.
Clause 71 there will be no injection or parenteral infusion of NHPs - this means no IV Vitamin C. It also means no IM Vitamin B12 which is a standard treatment and no iron infusions, so will be a disaster for conventional medical treatment also.
Clause 86 allows Health Practitioners (ones under the Health Practitioner Competency Assurance Act, so Doctors, Nurses, Pharmacists, Chiropractors) to dispense medicines. for their own clients, or at the request of another practitioner. They can also compound medicines. (Pharmacists get their own section, they can also dispense prescriptions and sell Pharmacist only, Pharmacy only and General Sales medicines).
However Natural Health Practitioners do not get the same thing. Under clause 112 we can manufacture for a client that we have had a consultation with. We can’t sell wholesale to other Practitioners, we have to have a consult with the person we are selling to, and we cannot send an NHP overseas to a client if they are not normally resident in New Zealand. If you have a Homeopath in one town and you live somewhere else and want to collect your prescription from a local Homeopath so you can get it faster - you can’t. I have a few clients overseas. If they can’t source a remedy in their country I post it to them - but under this law I will be unable to do that. Those small businesses selling herbal tinctures will not be able to do so unless they have a consultation with each sale, and they cannot supply wholesale to a shop.
Clause 252 is scary for me- if an impermissible health benefit claim is made about an NHP by an individual they could be liable for a $200,000 fine or 5 years in prison. This may make many small businesses unable to talk about what sorts of things their herbal tinctures or aromatherapy ointments could be used as this is making a claim and the fines are out of proportion to income for these micro businesses. Could my posts be construed as making claims- possibly. One Homeopath commented that it is not safe to talk about remedies, and this clause will make that a reality.
Clause 330 is about the regulator - one person to oversee every medicine, medical device, active pharmaceutical ingredient and natural health product in New Zealand. This is huge, and so broad that it would be impossible to have enough knowledge to do the role justice.
In my opinion this is a job for a medicines and medical devices regulator, and a separate role for NHPs.
Clause 346 is also problematic, that they can take the decision of an overseas entity and use this for New Zealand. Do we want to allow the Regulator to do this? Australia has already been shown to be biased against Homeopathy with their fraudulent NHMRC review, and the FDA has also come out with a policy (not a law) which is anti-homeopathy. With this clause we open the door to losing sovereignty, with the Regulator able to adopt and follow agendas from overseas. This is also risky for our Rongoā Māori and Treaty of Waitangi obligations as no other country has any understanding of Te Ao Māori.
Following on is clause 347 about Advisory committees. This should be strengthened, as in this Bill while they advise the Regulator it is not binding, so comes back to the Regulator and their knowledge and biases. Also, the Regulator needs to be “satisfied [members of the committee] have knowledge, skills, and experience” relevant to the issue. This is not satisfactory - it should be qualifications in the appropriate medical or NHP discipline, AND experience in New Zealand. I am not qualified to assess traditional Chinese medicine supplements, and so I should not be involved in making decisions about them. Likewise, the people who should be making decisions about homeopathic products are qualified Homeopaths themselves, those who have completed a diploma or degree in Homeopathy, not just done a short course.
This Bill is aimed at big businesses, those who have multiple products on the market and a big turnover. Natural Health Practitioners and small business owners will be collateral damage. Any costs incurred by these businesses will have to be passed on to the consumer. There is already a wide range of cost for different supplements, some practitioner only ones costing dollars every day. That will only increase with this bill, making preventative health a luxury.
If you have read this far, thank you. PLEASE write a submission - https://www.parliament.nz/en/pb/sc/make-a-submission/document/53SCHE_SCF_BILL_130084/therapeutic-products-bill
Say whether you support or oppose the bill (I will be opposing the bill) and then write about what the issues are for you with this bill.
I hope if we get enough support they will see the error of their ways and we can stop this bill before it becomes law.
Credit to Sonia Pechner for organising the group and also Lora Hagemann, Mike Dong, Angela Hair, Sarah Penrose and Jem Moon who came together last week so we could discuss these issues.