Little to no recent research was considered in the Medicines Classification Committee’s recommendation against making medicinal cannabis products more readily available
The Medicines Classification Committee has recommended against a change to allow for over-the-counter pharmacy-only sales of low-dose cannabidiol products (up to 150mg/day, in packs of up to 30 days’ supply).
The proposal was on the trans-Tasman harmonisation agenda with a mind to bring our treatment of medicinal cannabis in line with Australia’s.
Cannabidiol is available as a prescription medicine, but so far cannabis-derived medicines have only captured an estimated 6 percent of patients, with the black market still the largest supplier.
A major point in the committee’s recommendation to Medsafe that no change be made was potential safety issues relating to drug-drug interactions with cannabidiol and the lack of an established long-term safety profile.
No current products in New Zealand would have been able to meet the proposed requirement of having gone through the full medicines classification process rather than the Medicinal Cannabis Scheme.
Aside from input from five stakeholders, Medsafe itself and the Medicinal Cannabis Agency, the committee’s primary source of information was the Australian Government’s Therapeutic Goods Administration review in late 2020.
The administration review resulted in down-scheduling cannabidiol (CBD) to allow for over-the-counter sales. Though it was reviewed with the purpose of assessing the benefits of harmonising with Australia’s regime, the evidence was deemed insufficient for New Zealand.
Southern Medicinal executive director Greg Marshall said he was concerned by the reliance on older data to make a recommendation to the powers that be.
“I am concerned about the advice the minister receives saying there’s not enough evidence to come to a conclusion on the impact of CBD. That’s wrong.”
He said while leaning on resources from 2020 or earlier when reviewing an obscure drug with very little research might be OK, it wasn’t sufficient for cannabis, which has thousands of peer-reviewed research documents released every year.
To Marshall, who isn’t exactly enthusiastic about low-dose cannabidiol products, it’s not about whether the data used showed it was effective, but that the best and most relevant data is used when making decisions no matter the medicine or condition.
He referred the committee to a study by the Lambert Initiative for Cannabinoid Therapeutics out of Australia which found little in the way of high-quality existing evidence to support the efficacy of cannabidiol at lower doses but that it had a “remarkably safe profile” for doses up to 40 times the proposed level.
Impact on business
Entities that submitted on the review in favour of down-scheduling cannabidiol included NZX-listed Rua Bioscience, Zeacann, the Medicinal Cannabis Council and the Pharmacy Guild.
Zeacann director Chris Fowlie supported the change as a first step (albeit one that would be difficult to meet), and said the proposed change may have assisted some industry players in attracting new investors or providing an incentive to manufacturers with deep pockets.
Rua’s submission said the classification change would have been a positive signal to the industry to accelerate product development research and the compilation of data.
The Ministry of Health is working on a review of medicinal cannabis settings, but it has been continually pushed back.
Medsafe and its Medicines Classification Committee did not respond in time for publishing.