Kiwi medicinal cannabis producers are welcoming Medsafe’s decision to allow people to buy low-dose cannabidiol (CBD) without a prescription issued by a doctor.
However, they expect it will take significant investment over a few years for products to be approved for sale by pharmacists.
Helius Therapeutics, which already has four CBD products available in New Zealand via prescription, will gear up to do the clinical trials required to get the approval.
Cannasouth wants to commercialise technology aimed at improving the absorption of its products before looking at clinical trials.
Meanwhile, clinical trials aren’t on Rua Bioscience’s radar.
Medsafe, the authority responsible for the regulation of therapeutic products in New Zealand, in mid-October reclassified low-dose CBD from a prescription-only to a restricted pharmacist-only medicine for adults over 18.
CBD is a cannabinoid that has little-to-no psychoactive effects, unlike tetrahydrocannabinol (THC), and can help relieve pain, support sleep, and reduce anxiety.
CBD producers will need to get their products approved under the Medicines Act 1981 for them to be sold without a prescription.
This process will require them to do clinical trials to demonstrate exactly what their products achieve, and which conditions they address.
Helius chief executive Carmen Doran said the company was already doing clinical observation studies, and clinical trials were part of its plans for the future.
She suggested Medsafe’s decision to reclassify CBD came as somewhat of a surprise, given the Medicines Classification Committee — which makes recommendations to the Minister of Health on the classification of medicines — advised against it.
Minutes for a meeting that occurred a year ago say the committee noted CBD medicines didn’t have an “established long-term safety profile” — something that would usually be expected to support the down-scheduling of a substance.
The committee noted there weren’t any low-dose (less than 150mg a day) CBD products approved in New Zealand, it wasn’t clear which conditions they would cover, and there were no clear accessibility issues.
The committee also worried there were “potential safety issues” around how CBD would interact with other drugs.
Nonetheless, Medsafe made the call to reclassify low-dose CBD, so it aligns with the way it’s treated in Australia.
Its figures show the prescription of CBD has been rising.
Between January and August, 39,160 packs of products containing CBD-only were sold — 78 per cent more than the 21,962 sold during the same period last year.
Doran believed reclassifying low-dose CBD would further improve access and affordability, and remove the stigma around CBD.
Cannasouth chief executive Mark Lucas was equally supportive of Medsafe’s move, saying it would prevent people from buying “so called” CBD products on the black market.
He said people were accessing cannabis — whether regulators liked it or not. He saw the reclassification of low-dose CBD as a pragmatic way of reducing harm.
Lucas recognised that proving how effective a low-dose CBD product is in addressing a particular condition, like pain, could be challenging.
He also noted the prevalence of the placebo effect in the testing of medicinal cannabis products, as there is a perception they can address a range of conditions.
At present, low-dose CBD is typically used in addition to other medication and isn’t commonly used on its own to treat a specific condition.
There are also several government-funded products available to treat the sorts of conditions low-dose CBD helps with (Pharmac does not subsidise any medicinal cannabis products.)
As for Rua Bioscience, its chief executive Paul Naske said doing clinical trials was “no small feat by any stretch of the imagination”.
He noted with other companies around the world also doing clinical trials, it was likely some would try to get their products approved for sale by pharmacists in New Zealand.
Naske said clinical trials were a low priority for Rua, as the company is focused on launching products in New Zealand, Australia, and Germany.
Jenee Tibshraeny is the Herald’s Wellington business editor, based in the Parliamentary press gallery. She specialises in government and Reserve Bank policymaking, economics and banking.