The expected down scheduling of CBD to make it available in pharmacies will ultimately be a good thing for consumers, according to Elixinol CEO Oliver Horn.
Under an application outlined by the Therapeutic Goods Administration (TGA), low-dose CBD – defined as 60mg per day for a maximum of 30 days – will be downgraded to schedule 3 of the Poisons Standard, making it available without prescription from pharmacies.
“If it happens, it’s really good news for consumers and the industry,” said Horn. “A lot of consumers can’t easily access medicinal cannabis and CBD products at the moment, and with the down scheduling, access will be through your pharmacy. It’s really good news for patients, and consumers, and us as an industry.”
Some industry members have voiced concerns that the down scheduling will provide little benefit to patients. The Medicinal Cannabis Industry Association (MCIA) has shared concerns it could be a political “quick fix” that creates confusion, while Rhys Cohen, principal consultant with FreshLeaf Analytics, said the application could turn into a “red herring“, with companies facing “onerous” challenges to get product over the line, particularly at such a low dose.
However, Horn countered: “We take a more positive stance. From both our US and European experience, we’ve seen how many lives are positively impacted by well formulated and high-quality CBD products. There is no doubt that Australians are missing out and are hence taking matters into their own hands to source products that are, at times, of dubious quality.
“Giving access to high-quality products via pharmacy distribution responds to the growing consumer demand while enhancing product compliance and correct application and use. It also creates broader awareness among health care professionals which in turn will provide a broader range of options in treating certain indications.”
Schedule 3 CBD products will have different customers with different needs, he said, distinct from higher dose schedule 4 CBD products for patients with more severe symptoms like epilepsy and seizures.
“The down scheduling will not remove schedule 4,” he said. “Schedule 4 will continue to exist, which is higher dose medicinal cannabis. Schedule 3 is low dose, milder severity, milder symptoms, not the severity that schedule 4 products will provide for. So you’re going to see two levels of product emerging: high dose, high efficacy, low dose, lower efficacy for milder symptoms, and they will exist at the same time. It’s not one or the other.”
When it comes to price, Horn believes the down scheduling can only be a good thing for consumers looking for more affordable CBD: “The daily doses or monthly treatments range from $200 to $300 at the moment. It’s really expensive. Those prices are expected to come down very quickly, simply because there’s going to be more players coming into the market. That creates natural competition, which is good for the consumer.”
Horn said he expects prices to halve once the down scheduling takes place: “Competition is a good thing for consumers. So I expect prices to go down about 50 or 60% relatively quickly.”
Outside of the legally approved medical channels, access to CBD in Australia is currently confined to grey and black market products, often ordered online from overseas.
“It’s a minefield,” said Horn. “You don’t know the quality standards, the purity, the efficacy, how much THC is in there, how much CBD. There are just so many cowboys out there, and that’s why I think that a move to schedule 3 will take a lot of heat out of the market.
“People are no longer reliant on a third party that sits in a different country to parse out your product, where you have no idea where and how it’s being produced. As a consumer, why would you take the risk ordering it online when you can go to Chemist Warehouse, speak to a pharmacist in person and get a good recommendation?”
Despite the positive effects of down scheduling, there will still be an adjustment period, Horn said. In order for companies to be able to sell their CBD products, they first need to register their specific drug on the Australian Register of Therapeutic Drugs. Horn admits that at the moment, it’s not completely clear what’s required to do that.
“It’s not clear what clinical data, what support is needed. Is it clinical data from desk research, or is it primary clinical data? What medicinal cannabis formulations are going to be allowed? Do they need to be 98% pure CBD or not? Are multi-broad spectrums allowed, or does it need to be distillate and isolate? So the product formulations are not clear. The clinical data is not clear. And so we certainly see that it will take time.”
“It’s probably going to take a couple of years for all pharmacists to become equally comfortable and a wide variety of products being listed on the ARTG and available. Pharmacists need the time to adapt to this new environment, they need to up-skill their staff to understand and prescribe for the right indications, to prescribe the right products, and that will take time.”
In a schedule 3 environment, the marketing and advertising of CBD products becomes possible, but will still remain tightly controlled, he said. “It still needs to be TGA compliant. All of the ingredients that are in the product need to be listed on the appendix page of the Poisons Standard, and then you can advertise it to the masses.
“So advertising and marketing can actually happen to the masses under restrictions and with the right disclaimers. We will see that advertising driving much broader acceptance, and I expect that to happen pretty soon, in the next year.”
However, the low-dose CBD allowed in schedule 3 means marketers will remain unable to make any health claims. “So it really then relies on people understanding what CBD actually does for you,” he said. “All you can say is what the product is, what per cent CBD it contains. You can talk about the format, the dosage, but you can’t make any health claims.
“Basically it tells the consumer it’s available at the pharmacy. ‘Go to Chemist Warehouse to get your pharmacist’s advice’, or ‘consult your pharmacist for advice.’ But at least you’re creating awareness that those products are now in the mainstream. And I think there’s an undercurrent. People are already looking for those products. The moment they see it available in their Chemist Warehouse, they’re going to pop in and ask the pharmacist. And that’s where the change really happens.”