This is one more post about the Therapeutics Products Bill. THANK YOU to those of you who have already made a submission. If you have not yet done so I urge you to have your say – it can be as brief or as long as you like. It doesn’t have to be the best grammar and spelling, and please don’t copy a generic post, but write from your heart what you feel this bill will mean to you.
You have until March 5th, please make your submission here: https://www.parliament.nz/en/ECommitteeSubmission/53SCHE_SCF_BILL_130084/CreateSubmission
If you would like to read more about it you can see my post about individual clauses here: https://www.facebook.com/100063496093427/posts/634592718667259/ and you can get a copy of the Homeopathic Society Guidance document on how to make a submission from firstname.lastname@example.org
I would like to talk a bit about herbs and the potential impact for us all. In doing so I want to discuss the past, specifically Artemisia Annua.
Artemisia Annua is sweet wormwood, and New Zealand research showed a number of years ago that it was effective for arthritis- and so was marketed as Arthrem and sold through New Zealand in Health Stores and Pharmacies.
From 2016-2017 CARM (the Centre for Adverse Reaction Monitoring) had 14 reports of jaundice, and an alert was issued to prescribers. After further reports to CARM, and with the “therapeutic purpose” of treatment of arthritis in 2019 the Medicines Classification Committee reclassified this as a medicine. While this protected members of the public from the risk of liver damage, it also made this herb effectively unavailable to people it would help as it cannot be supplied by a qualified and registered Natural Health Practitioner. If you would like to read the full document about their decision, it is available here: https://www.medsafe.govt.nz/profs/class/Agendas/Agen63/MCC63_72e_artemisiaannua.pdf
There has been some thought that this bill will prevent incidents like this from happening. This bill does allow “health benefit claims” under clause 61, either general claims for that product, or specific ones agreed to by the regulator under the product market authorisation. However, when you read the Medicines Classification Committee document it is clear that it was not just the “therapeutic purpose” that led to the reclassification – after all there are many products available that make claims that could be construed as a therapeutic purpose – but the combination of this with the risk of harm due to liver damage and QT prolongation- aka changes in heart rhythm.
So let’s consider risk, and how that is mitigated in New Zealand. For medicines, we have four categories – General Sale, Pharmacy Only, Pharmacist Only, and Prescription Only. There can be restrictions on pack size for General Sale, like we see with Paracetamol and Ibuprofen, and there are often differences in packaging between Pharmacy Only and Prescription versions of the same medicine. There is no similar legislated system for Natural Health Products – they are either general sale or not available. There is industry self-regulation, with Practitioner only products that are of high quality, therapeutic dosing, specific combinations and usually a high level of testing and scientific research, but this is industry led, and not acknowledged in existing legislation – and more importantly this is also not acknowledged in this current Therapeutic Products Bill.
Because there is no facility to restrict certain products to qualified and registered Natural Health Practitioners, which would allow safe use and monitoring of these products within the scope of practice of a Medical Herbalist or Naturopath, the same solutions apply to the regulator if there is deemed to be a high risk from the product as now: either make it a Prescription medicine under clause 21 or prohibit it under clause 33.
One solution here is to formalise the practitioner only designation for Natural Health Products. After all, that would allow the restriction of NHPs that have some risk to those most qualified to prescribe them. If this was introduced it could also prevent the loss of some useful homeopathic remedies of human origin, however there is another problem with this: who is making the decision.
But again we have to come back to the regulator, a person with “appropriate experience and expertise” (clause 330). There are few people who have the appropriate experience and expertise in not just conventional medicine but also in complementary and alternative medicine. Furthermore, the advisory committees are non binding, and need “knowledge, skills, and experience relevant” but that does not mean a qualification in that particular field, and given the huge variations in complementary medicine disciplines there is a real risk of one or more modalities being overlooked and becoming collateral damage.
I have real concerns about the impacts of this bill on the entire Complementary and Alternative medicine industry. Unfortunately while some think the ability to make Health Benefit Claims will prevent the loss of herbs such as Artemisia Annua, if there is deemed to be a risk they can and will still be taken off the market and made prescription medicines or banned completely.