Zeacann sticks up for patients, making one of just five submissions received by Medsafe's Medicines Classification Committee about a proposal to make cannabidiol (CBD) pharmacy-only.
The medicinal use of CBD is legal in New Zealand with a prescription which can be obtained from any doctor, for any reason. That's great!
But other countries, including all of Europe and North America, do not require a prescription and CBD may be purchased over the counter from any store.
Australia's Therapeutic Goods Administration recently approved making "low dose" cannabidiol phamacy-only. This would mean packs containing doses of up to 150mg per day, to a maximum of 30 days, would not require a prescription there.
New Zealand's Medsafe then asked their Medicines Classification Committee to consider harmonising with Australia.
Medsafe and the Medicinal Cannabis Agency provided some regulatory advice (PDF document 305KB, 21 pages), specifically pointing to a review of the safety of low-dose cannabidiol conducted by Australia's TGA.
Here is Zeacann's submission on the matter. The other submissions were from The Hempstore, Rua Biosciences, the Medical Cannabis Council, and the Pharmacy Guild.
3 October 2022
MCC Secretary, Medicines Classification Committee By email: [email protected]
Cannabidiol (CBD) scheduling, 69th Meeting of the MCC
Tēnā koutou, thank you for this opportunity to provide guidance to committee members regarding the proposed re-scheduling of low-dose cannabidiol (CBD) medicines.
About us
Zeacann was founded in 2017 and currently holds a Medicinal Cannabis License for one site (at CompoundLabs in Auckland), with a Nursery activity. Zeacann has an interest in both importing and locally manufacturing CBD products.
The problem
Cannabidiol (CBD) is a naturally occurring cannabinoid that is often extracted from hemp, or high-THC cannabis. CBD can also be manufactured synthetically. Notwithstanding the progress to date, we are regularly contacted by patients and medical professionals enquiring about the availability of CBD products. It is commonly expressed that existing products are too expensive and limited in options (such as dosage format, strength, formulation). No medicinal cannabis products, including CBD products, are subsidised by Pharmac. This means cost and affordability are big issues for many patients.
From an industry perspective, the product approvals process remains very difficult to meet. It is unlikely that many – if any – products will go through the full consenting process. In fact, that assumption is the reason we have a Medicinal Cannabis Scheme separate from the regular consenting process.
Proposed changes
The proposed changes would allow over-the-counter Pharmacy Only sales of low-dose cannabidiol products (up to 150mg/day, in packs of up to 30 days). It is proposed that these changes would apply only to products that have gone through the full medicines classification process (i.e. not products available under NZ’s Medicinal Cannabis Scheme).
This would in turn mean such consented products could be marketed, with therapeutic claims for which evidence has been met, and could be provided by a Pharmacist with or without a prescription.
Zeacann supports the proposed change as a first step. However, it would currently apply to no products, as none have Ministerial consent. In theory it could benefit Epidiolex (manufactured by GW Pharmaceuticals in the UK) which is approved by the FDA although it has not yet received consent in New Zealand. However, Epidiolex is a high dose product and unlikely to qualify.
The proposed change may assist some industry players in that it may attract new investors or provide an incentive to manufacturers with very deep pockets, or who have the backing of billionaires. But the consenting process remains slow and expensive, Medicines often take years or decades to reach the market via the regular consenting process, at a cost that can run to hundreds of millions of dollars.
We are mindful the Medicinal Cannabis Scheme was created expressly because the standard consenting process is recognised as too onerous and slow to meet the immediate needs of patients. In addition, the regular consenting process is not seen as viable for herbal medicinal cannabis production, including CBD products.
Looking to Australia, the change appears to have made no difference so far. We have not found any Pharmacy-Only CBD products there and have not seen any significant industry player announce new investment or strategy in this area.
While further changes are deemed by Medsafe as outside the scope of the Committee, we encourage members to make recommendations for further reform, especially given the scheme has been going 2.5 years with an estimated uptake by patients of only 6%, and a long-promised review of the scheme still not in the public domain.
New Zealand authorities should look to North America and Europe – not just Australia. It is common overseas that hemp-derived CBD products are not included in medicines regulations or schemes and are available on general sale in addition to having consented products available under prescription or, as in this proposal, available from Pharmacies. The CEO of Zeacann and author of this submission, Chris Fowlie, recently returned from Europe where he found CBD products on general sale in every country he visited. CBD products were also available from doctors and pharmacies. He reports it was difficult to find any problem with this approach.
Recommendations
Zeacann Ltd supports the proposed changes for cannabidiol. However, we believe the proposal does not go far enough to make a meaningful and timely difference for patients.
We recommend all hemp-derived CBD products be available over-the-counter on general sale (in addition to the current proposal, and noting that any product assessed as meeting the NZ Minimum Quality Standard would also be available by prescription).
Ngā mihi,
Chris Fowlie CEO,
Zeacann Ltd