Medsafe's Medicines Classification Committee recently considered rescheduling cannabidiol (CBD) to general sale in pharmacies to bring New Zealand in line with similar changes already approved in Australia.
Here is the submission we sent from The Hempstore, supporting over the counter access with no prescription needed.
This was one of five "comments" received by the committee on the proposal by Medsafe. The others were from Zeacann Ltd (run by The Hempstore's boss Chris Fowlie), Rua Biosciences, the Medical Cannabis Council and the Pharmacy Guild.
Medsafe and the Medicinal Cannabis Agency provided some regulatory advice (PDF document 305KB, 21 pages).
4 October 2022
Medicines Classification Committee
Ministry of Health
By email to: firstname.lastname@example.org
Re: CBD scheduling – 69th meeting of the Medicines Classification Committee
About us and our experience
The Hempstore is an Auckland-based retailer of hemp and cannabis-related items, founded in 1997. We write to offer our experience in this area. We are grateful for this opportunity to correspond with you on a matter that is very important to us.
Customers regularly enquire about the availability of CBD. They expect that we can provide it to them. We receive enquires every day – sometimes many times per day.
We explain the law and how they can access it legally through a doctor. Many customers are surprised and shocked to discover accessing CBD legally requires a prescription. Very few give any indication they will seek it through a doctor; they are concerned about onerous processes and unaffordable products.
Visiting tourists inform us they can buy CBD over the counter in North America and Europe, with few restrictions on pack size, strength, dose or format. They must go without their medication while visiting New Zealand. Tourists often seem taken aback that New Zealand operates so conservatively, while some have noted to us that no one has died from taking CBD and there is no controversy around this.
In fact, in many places a store like ours is exactly where people expect to find CBD products, and are capable of doing this. Our staff have the experience and expertise to safely provide CBD products to customers for their health and wellness purposes.
We believe that this international experience of CBD as a common health and wellbeing product was the intention of the United Nations in calling for provisions for it’s use. We note that despite changes in NZ law in response to this, the outcomes of our Medical Cannabis Scheme has not matched it’s intended spirit. As a result, New Zealand is considered somewhat backward in this arena.
The proposal is weak but a step in the right direction
The proposed changes, as we understand them, will bring New Zealand rules in line with Australia, allowing over-the-counter sales of qualifying low-dose CBD products in pharmacies.
That does not go far enough. The Australian approach has not made any material difference to patients there, or to the viability of their local industry, because it only applies to products that have gone through the full medicines approval process. Currently, that is none.
We might hope that Epidiolex would qualify if they applied, but note it is apparently the world’s most expensive CBD product and is not actually available in Australia or New Zealand.
The wider framework for this issue is the unnecessary medicalisation of CBD. The international experience of our customers is that low dose CBD is a hemp product : a herbal supplement, or an over-the-counter painkiller at most.. But while the legislative framework adopted here in New Zealand correctly excludes CBD from the Misuse of Drugs Act, by shunting its regulation entirely into The Medicines Act, it has effectively scuppered the intention of making products widely available to Kiwis. The expensively high standards required for pharmaceutical grade products have shut small local producers entirely out of the market and forced consumers into an unnecessary prescription process over a medicine that functions on about the same level as paracetamol.
Low dose CBD products should never have been treated like prescription level medicines, but instead belong under ordinary hemp regulations, like most other juristictions. This would still provide consumers with full assurance that products are not contaminated by agricultural chemicals, disease, or mishandling; which is all that should be required for a herbal medicine of mild strength and very low risk. Medical grade, prescription-only CBD products would remain available under The Medical Cannabis Scheme, for those who require this level of medication.
Bolder change is required
Notwithstanding Medsafe’s guidance to only consider what could happen within current regulations, we encourage the committee to send a message and recommend bolder steps, even if Medsafe’s constraint is adhered to now.
We encourage you to recommend further steps to provide more equitable, and risk-proportionate, access to CBD Products, by recommending that cannabis regulations should be changed, and the Medicinal Cannabis Scheme updated to facilitate access that is more broadly aligned with Europe and North America.
The bottom line
1.MCC support the current proposal (as a minimum first step)
2.MCC encourage further changes to allow:
a.Pharmacy-only provision of any CBD Product approved under the Medicinal Cannabis Scheme (i.e. assessed as meeting the NZ Minimum Quality Standard)
b.In addition, general sale of low-dose CBD Products as described by the current proposal (i.e. up to 150mg per day x 30 days)
c.Idealy, b. would be achieved by the complete removal of all low-dose CBD products from the Medical Cannabis Scheme, and they would be regulated on par with hemp foods
Thank you for considering our submission.
Harm Reduction Officer
The Hempstore Aotearoa