Cannabis oil poised to change Australia’s pharmaceutical market

Low dose cannabis oil can now be bought over the counter at pharmacies in Australia, but products containing it have not been approved for sale yet.

The Therapeutic Goods Administration (TGA) announced in December 2020, that it would “down-schedule” some low dose cannabidiol, otherwise known as CBD.

This would allow pharmacists to dispense up to 150 mg of CBD a day without a prescription.

According to the Pharmacy Guild of Australia, manufacturers are working rapidly in trying to get products approved for sale in pharmacies.

Dr John Barlow from Applied Cannabis Research, and the Principal Investigator of the CA Clinics Observational Study says cannabinoids can be effective at treating symptoms of chronic illnesses.

“The focus is particularly in something like endometriosis on reducing the pain associated with that particular condition,” Dr Barlow says.

“It would be the same for a range of other conditions, it reduces pain, it reduces anxiety, but it also reduces things like sleeplessness, but the reason people sleep poorly is because they’re in pain, so if you reduce the pain, the likelihood is that they’ll start to sleep better.”

Endometriosis a condition that affects 11 percent of Australian women, can severely reduce quality of life for those affected – a loss of potential estimated at $AU4 billion dollars.

A review by the World Health Organisation found that CBD – the active ingredient in cannabis products – did not lead to drug abuse or dependence.

According to the Penington Institute’s Annual Overdose Report, there were 2070 drug overdoses reported in 2018 – 1,556 of these deaths being unintentional, with opioids present in 900 of these overdoses.

CBD could be life-changing, and potentially lifesaving, for Australians dependant on pharmaceutical opioids to manage their symptoms of pain.

“Cannabinoids, particularly CBD, is able to reduce the symptoms of pain in some people. In studies that we’ve done, in about 60 percent of people who’ve been taking cannabinoids, have an amelioration of their pain symptoms,” Dr Barlow says.

But he adds that CBD is not the panacea for all health problems.

CBD won’t work for everyone, and for those that it does, it won’t eliminate pain, but reduce the amount of pain they feel, “which then can mean they can reduce the number of opioids that they take.”

“So, instead of taking a large amount of opioids, the suppositional proposal is that they would take a cocktail of opioids and cannabinoids, and that would have the same effect as a large opioid dose – or even a better effect – that’s our approach to the opioid overdose crisis,” he says.

Dr Barlow says the current medicinal cannabis industry is on track to inject 100 million dollars into the Australian economy, but proponents of cannabis say complete legalisation would be even more beneficial.

“According to the Greens, the legalisation of cannabis would inject about $3.5 billion into the economy. And in actual fact, if their forecast is correct there would be about $4.5 billion of adverse events that occur with opioids that would be reduced. So the actual financial benefit would be quite large.”

There has been extensive research into cannabis over the last 40 years, primarily defining the 400 chemicals that make up marijuana – especially the two primary cannabinoids tetrahydrocannabinol and cannabidiol, THC and CBD.

“And we know to a certain extent what they do, but there are aspects of that that we don’t know, quite a few aspects that we don’t know.”

This is where Dr Barlow comes in – his work at Applied Cannabis Research is to make sure the bench top research done in the lab translates to a safe and effective treatment for patients.

“Because we don’t know precisely how it works, or how efficacious it is, so it’s called observational research which means we observe the results of people who have been prescribed cannabis, or a cannabis derivative of some sort…We observe their treatment and measure how they respond.”

So, what challenges will researchers face when working to generate the data and evidence necessary to get a drug like CBD approved for distribution?

“Cannabis has had a fairly bad track record; it’s attracted not a positive press,” Dr Barlow says.

“In the first instance the difficulty that we had was finding a supplier because there were no people growing it – because they weren’t allowed to grow it.”

The Australian parliament made amendments to the Narcotic Drugs Act on 24 February 2016 that legalised the growing of cannabis for medicinal and scientific purposes.

Medical cannabis was then legalised at the federal level on 1 November 2016.

“So people were then demanding to be able to use the drug. But the TGA wasn’t going to just release it without some data or some medical background from somebody justifying why they should be allowed to take that particular drug.”

The Special Access Scheme, otherwise known as (SAS), allows certain health practitioners to access what the TGA calls ‘unapproved’ therapeutic goods for a single patient that aren’t included in the Australian Register of Therapeutic Goods.

SAS Category B applications are individually considered by the TGA based on the information provided with the application.

“Which was a fairly convoluted and paperwork heavy process, and that did put off a lot of medical practitioners to prescribing the drug. Now, fortunately, the SAS-B process has been streamlined so it’s a little bit quicker,” Dr Barlow explains.

As of 28 February 2021, the TGA approved more than 99,000 SAS Category B applications for unapproved medicinal cannabis products.

Now researchers must prove to the TGA that CBD is safe for the community.

“So our first challenge then is to generate data which is sufficiently informative and properly quality controlled so that the TGA can say ‘yes, if that’s what the drug does then we’re prepared to allow it to be prescribed by a medical practitioner,” Dr Barlow says.

He adds that there’s still a lot of research to be done before any products get approved for prescription or over the counter sales.

“That process in my opinion is going to be about 5 years away, which is a relatively short period of time…That’s because of the interest in the compounds and the fact that we’re focusing on what it is that they do – not just here but overseas as well.”

But the Australian Medical Association, the Advisory Committee on Medicines Scheduling, and the Advisory Committee on Chemicals Scheduling are all against the TGA’s decision to down-schedule CBD.

These organisations believe there’s insufficient evidence to relax access to CBD. The AMA says the TGA has a responsibility to encourage the use of medicines that are included in the Australian Register of Therapeutic Goods, before applying for access to unapproved cannabis products under the SAS-B process.

Cannabis has developed a negative stigma in society as a dangerous narcotic associated with crime, but Dr Barlow is hopeful that Australians will begin to see through these misconceptions.

“If you speak to a pharmacist, they’ll confess that about 50 percent of the drugs that they deliver are made up from things that are derived botanically – even opioids, they’re grown in Tasmania in poppy plants before they’ve been purified and find their way into your arm if you’re about to have a surgical operation,” he says.

“Cannabis is no different, it’s a botanically derived compound that we’re beginning to understand, and in that process of understanding we’re beginning to understand how valuable they will be for us as a legal therapeutic.”