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CBD will go on sale in Australia, but first manufacturers will have to prove it works

While CBD has been approved for over-the-counter sale, there are regulatory hurdles to clear before it actually appears in pharmacies

CBD, a compound found in cannabis that does not have psychoactive effects, is now legal to sell over the counter. But don’t expect to find any in your local pharmacy yet. Photograph: Anatoliy Sizov/Getty Images/iStockphoto

CBD, a compound found in cannabis that does not have psychoactive effects, is now legal to sell over the counter. But don’t expect to find any in your local pharmacy yet. Photograph: Anatoliy Sizov/Getty Images/iStockphoto

Last modified on Sat 6 Feb 2021 19.02 GMT

“Y ou 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.”

While CBD has been approved for over-the-counter sale, there are regulatory hurdles to clear before it actually appears in pharmacies

2021 is giving us over-the-counter medical cannabis

Low-dose CBD cannabis oil can be sold in pharmacies from next year.

From early 2021 you’ll technically be allowed to buy low-dose cannabis oil from pharmacies without a prescription.

However, while the laws have been changed so you can buy CBD oil over-the-counter, there are currently no products approved for sale.

Firstly, these products won’t get you high. This is only low-dose CBD oil we’re talking about and products won’t be allowed to have more than 1 per cent THC (which is the psychoactive part of the plant).

When the changes come in on February 1 next year, the maximum dose for adults will be limited to 150mg per day, which is why it’s considered low-dose. It’s expected patients would use this to help them sleep, reduce anxiety or depression and treat pain, although there’s currently not much evidence the oil is effective at this strength.

The decision from the Therapeutic Goods Administration (TGA) changes low-dose CBD oil from a schedule four drug, which doctors have to prescribe, to a schedule three drug, which chemists can hand out over-the-counter without a prescription.

Cassandra Hunt, the managing director of cannabis industry consultancy, Fresh Leaf Analytics, told Hack the change is significant.

“It’s the biggest milestone since legalisation in 2016 and it’s going to dramatically change access for patients in Australia.”

She says this will make life much easier for people who want to use this drug.

“Previously, they’ve had to go to a GP and they’ve had to talk to the GP about what they’re trying to treat, and then the GP has had to get special permission in order for them to be able to access a prescription.”

There will be a wait for products

While the changes will come into effect in early 2021, it could be years before there’s actually a product to buy.

Cassandra Hunt from Fresh Leaf Analytics told Hack that it’s unlikely anything will be on the shelves in February.

“In order for companies to get these products registered or available over-the-counter in pharmacies, they have to be registered as an S3 medicine,” she said.

“What that requires is quite significant data about the safety and efficacy and quality of the products.”

According to Cassandra, because the Australian cannabis industry is still so new, they don’t know how effective their low-dose CBD products are and it could take years to get that data.

She says it’s not clear what info the TGA wants, but if it’s expecting companies to run clinical trials then it could be a five-year wait for products.

“That data, given the industry is so young, isn’t easy to come by.”

Medical Association “surprised” by down-scheduling

The Australian Medical Association (AMA) doesn’t support the TGA’s decision to down-schedule low-dose CBD oil.

In a statement to Hack, the AMA said it isn’t confident pharmacists have the education to properly advise patients, and that side effects could go unchecked.

“Medical practitioners have only been prescribing CBD products for a few years, the evidence is still emerging, more education around its use is required,” the AMA said.

When it comes to possible side effects, the medical association fears doctors won’t be able to properly monitor patients when the CBD oil is sold through pharmacies.

“There is a risk that patient conditions that are associated with CBD use (e.g. anxiety, psychosis, chronic non-cancer pain, and epilepsy) will go unchecked and cause further harm to the patient,” the AMA told Hack.

The TGA told Hack the decision to make low-dose CBD oil available over the counter wasn’t based on how well it works, just that it isn’t harmful.

“The scheduling decision was made on the basis of the safety profile of CBD at this dose,” a TGA spokesperson said.

Cassandra from Fresh Leaf Analytics admits evidence of how well these products work is hard to come by but agrees they’re not harmful.

“There is good safety data to show that at the types of doses we’re talking about CBD is very safe.”

The illicit silver lining

According to Cassandra Hunt from Fresh Leaf Analytics, the TGA could also be trying to move CBD users away from the black market.

“I think one of the other motivations of the TGA is to make it easier for people to access these products where they might otherwise be using illicit channels,” she told Hack.

“The problem with some of the illicit channels is that the quality of the products is not always good.”

“Sometimes those products say they have something in them and that’s not in there, so you can’t really rely on the fact that you’re getting a good product.”

She also says that for the first time, as the cost of medical cannabis production comes down, legal products are reaching price parity with the illegal market.

“If you couple that with making it more easily accessible through pharmacies, that should hopefully make a big difference for people who’ve been getting relief through those channels, but maybe can’t rely on those products being good quality.”

From early 2021 you’ll technically be allowed to buy low-dose cannabis oil from pharmacies without a prescription.