18/01/2023
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. This will affect our small businesses the most.
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 D**g, Angela Hair, Sarah Penrose and Jem Moon who came together last week so we could discuss these issues.
