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is cbd oil legal in australia

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

‘We know it works’: Cannabis oil firms chase approvals as over-the-counter sales are legalised

By Julie Power

Low dose cannabis oil can be bought over the counter at pharmacies from Monday for the first time, but don’t expect to find any for at least six months as none has been approved for sale yet.

Manufacturers are working at a “lightning” rate to get products approved for sale in pharmacies, the former president of the Pharmacy Guild of Australia, Kos Sclavos, said.

A worker on the first farm licenced in NSW to produce medicinal cannabis prunes a plant. Credit: Janie Barrett

FreshLeaf Analytics, specialists in the Australian medicinal cannabis industry, said the first company to get its product on chemists’ shelves will have a significant advantage in a market estimated to exceed $200 million a year.

The Therapeutic Goods Administration (TGA) announced in December that it would “down-schedule” some low dose cannabidiol (CBD) preparations of up to 150 mg a day to allow pharmacists to dispense this medicine without a prescription.

The Australian Medical Association opposed the proposal to sell cannabidiol over the counter. A spokesperson said it had not changed its position.

Cannabidiol is an active ingredient in cannabis that doesn’t make a user high. A review by the World Health Organisation found it didn’t lead to drug abuse or dependence.

Clinical research has shown it can help reduce anxiety, insomnia, post-traumatic stress disorder and pain, said Dr Ben Jansen, the director and founder of Cannabis Doctors Australia.

Dr Jansen said his practice specialising in medicinal cannabis was passionate about CBD because it was life-changing for about a quarter of patients.

Far from being a “demon drug” as it was thought of in the past, he said, “we know it works, but we want to find out how well it works.”

He said it would take “at least two million dollars and the appropriate data before (a product) can be registered for use for distribution by a pharmacist.”

Cannabis oil can be legally sold over the counter from Monday. Credit: Sakchai Lalit

Contrary to stereotypes, the vast number of CBD users were middle-aged women who took the medicine for pain relief, such as inflammatory arthritis, he said.

FreshLeaf’s analysis of the TGA ruling said many products prescribed by medical practitioners – after gaining special approval because the drug is currently unapproved – will meet the criteria for sale over the counter.

“History suggests that the first movers among product companies will be the winners, with the first movers in the medicinal cannabis industry in Australia still dominating the industry today,” said Cassandra Hunt, managing Director of FreshLeaf.

Mr Sclavos, a pharmacist who has specialised in medicinal cannabis, said the decision to allow pharmacies to dispense cannabidiol without a prescription was a major move forward for a “whole cohort of patients”.

The first company to start producing cannabis oil will have an advantage in the highly lucrative market. Credit: Janie Barrett

He had seen first-hand the “incredible improvement in the quality of life” that medical cannabis could deliver to a range of patients including epileptics.

Compared with other medicines, the response of each individual to CBD varies enormously among individuals, Mr Sclavos said. That meant that pharmacists will have a “bigger say” in adjusting the dose.

The TGA decision only applies to products that are on the Australian Register of Therapeutic Goods (ARTG).

To register a product, a company must demonstrate that the products are high quality, safe, and efficacious. This is a time-consuming process, said Freshleaf. Products may not appear on shelves until next year.

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Clinical research has shown it can help reduce anxiety, insomnia, post-traumatic stress disorder and pain – and it’s most commonly used by middle-aged women.