“You can have as much whiskey as you like, but there’s no whiskey available,” says Prof Iain McGregor, psychopharmacologist and academic director of the Lambert Initiative for Cannabinoid Therapeutics, when asked to describe the rules around CBD in Australia at the moment.
CBD is a compound found in the cannabis plant, but unlike THC, it does not have psychoactive effects. On 1 February, it became legal to purchase products containing low-dose cannabidiol (CBD) over the counter, after the Therapeutic Goods Administration down-scheduled the substance from a Schedule 4 (prescription medicine) to a Schedule 3 (pharmacist-only medicine). On 15 December, the TGA announced the decision after a safety review that indicated “known adverse events of CBD at low doses were not serious”.
But those afflicted with pain, anxiety or simple curiosity looking to buy CBD would have received a disappointing response from their pharmacists this week. While the substance itself is hypothetically legal, no product containing it has been approved by the Australian Register of Therapeutic Goods (ARTG) – a requirement of sale.
CBD’s medicinal status in Australia is much different from the situation in other countries where the substance is available without a prescription, such as the UK and US. In the UK, low-dose CBD oil can be sold as a dietary supplement, but not a medicine. In the US, the substance is not approved on a federal level, but in some states it is possible to buy everything from pet food to bottled water to Martha Stewart branded gummies containing CBD. “You have this runaway train that’s way beyond the evidence available,” says McGregor.
“Now we have approval, but in order for companies to get these products to market they have to … show that the product is safe, but also efficacious.
“And therein lies the problem – there are no good clinical trials that show CBD at 150mg [the daily dose approved by the TGA] is actually effective.”
“We don’t know if it will work,” says Assoc Prof Yvonne Bonomo, a physician in addiction medicine and chief investigator at the Australian Centre for Cannabinoid Clinical Research Excellence. “It may work for some people. It’s hard to know. That’s why we need to look at it.”
“If it’s going to be treated as a medicine, it needs to go through the processes medicines go through,” she says. “Other countries have used different pathways to make it available and they have different methods that aren’t as rigorous.”
Bonomo emphasises the importance of quality control, saying that the upfront work is worth it in the long run. “For products to be listed on the ARTG, there is a process. It’s a complex process, but it’s a necessary process to make sure that those quality products do get listed.”
The Australian Medical Association did not support the TGA’s decision to down-schedule the substance, citing the lack of ARTG-listed products – alongside the potential for interactions with prescription medicines, and a need for more evidence.
“We’re filling the gap of 70 years of prohibition where there was no research,” says Tommy Huppert, the CEO of Cannatrek, an Australian cannabis grower and manufacturer. Huppert’s company has just inked an exclusive supply deal with Chemist Warehouse, though what exactly it will supply remains to be seen. “Everyone’s really racing to get the product to market. What sort of mountain will we have to climb? Is it going to be weeks? Months?” he wonders.
Though ARTG registration is a high hurdle, there are huge potential earnings on the table. The director of Southern Cannabis Holdings, Tim Drury, believes the over-the-counter market for CBD oil will “exceed $200m per annum”.
That CBD is found in a plant subject to three seperate United Nations treaties is not the only thing that sets it apart from other medicines. It also differs because “we’re really talking about generic actives,” says Huppert. Rather than developing a new drug for a specific purpose, CBD manufacturers will have to run clinical trials to find out which purposes an existing and widely used substance is actually effective for. Or, as McGregor puts it, “the exact opposite of most drug development”.
There are plenty of wild health claims about CBD oil’s properties (which have resulted in TGA fines in the past). There is also lots of anecdotal evidence that CBD helps with everything from insomnia, to chronic pain, to anxiety, to epilepsy. Clinical trial data backs up some of these assertions – but only at much higher dosages than the TGA has approved.
“Now the challenge is the process of proving [the anecdotal evidence] … to list the medicine with an objective claim,” says Huppert. “It usually takes years and millions of dollars to bring a drug to market.”
And when it does arrive, it could well be a price point that will shut a lot of people out. In the UK, a bottle containing a 300mg dose of CBD oil – enough for two days’ use at the TGA-approved level – costs about A$40.
“You’re not talking about the prices of vitamins, or turmeric … you’re talking about a commodity that is quite sought after,” says McGregor. “That is the story that we hear over and over again [from patients], that they can’t afford the product.”
Right now, the ARTG has listed only one prescription CBD product for use in Australia, Epidyolex, which is approved for treating a form of severe childhood epilepsy. This is a far more narrow scope than the substance’s perceived potential.
At the Lambert Initiative, McGregor is running multiple clinical trials using low-dose CBD oil. He is soon launching one for a cohort he self-identifies with – “grumpy middle-aged people who don’t sleep well”. He says it is “a placebo-controlled clinical trial … And by the end of that trial, we’ll have a pretty good idea of whether that dose range is doing anything for that mildly grumpy, not-sleeping-well, mildly dysphoric demographic.”
However, even if that research – or the research by manufacturers – proves low-dose CBD is effective, he still believes it will be “six to 12 months” before any CBD products are available at pharmacies.
Bonomo believes that certainty is worth the wait. “We’re learning more about the way it works, and the groups for whom it seems to have a benefit. I think we’re on the right path. Moving forwards, carefully and safely, but moving forward.”