What’s the deal with getting and using CBD oil in Australia?
What you and your mates potentially know as CBD oil is actually cannabidiol, a compound found in cannabis/word you’ll probably have to try pronounce at least twice.
You’ve probably met its mate, delta-9-tetrahydrocannabinol (aka THC aka the one that makes you wicked ≋h≋i≋g≋h≋) but CBD will not get you stoned. (Unless you’ve got it from somewhere slightly dodgy and you’re not 100% sure about the THC content).
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So to be clear, CBD is used for medical reasons and NOT Reefer Madness. What kind of medical reasons? According to Dr Iain McGregor, Professor of Psychopharmacology, “It’s more a case of what it doesn’t do rather than what it does.”
What’s CBD good for?
It was first discovered in the 50s and 60s (in modern times) and was basically thought to be useless, says the Doc. That was, until the 70s, when we rediscovered its antiepileptic effects. But it really wasn’t until the past four or five years that there’s been a real increase in awareness and research.
“It’s become this almost universal panacea,” says Dr Iain. Depending on who you ask, CBD oil is good for what ails you, whether that be anxiety, anorexia, insomnia, PTSD, chemotherapy-induced nausea and vomiting, depression, migraines, or feeling chronically unchill.
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Neuropharmacologist, University of Wollongong lecturer and Associate Investigator with ACRE, Dr Katrina Green, also notes that after 12,000 years of interaction between humans and cannabis, our understanding of this plant is still very much in its infancy.
“CBD is obviously pretty important. Its anti-inflammatory capacity and its ability to protect the brain is evident in almost every study that you pick up.”
She finds these anti-inflammatory effects, even in low doses of cannabidiol, especially exciting since inflammation kind of underlies everything. “Low levels of inflammation are involved in body weight gain, if you pull a muscle. there’s such wide ranging benefits to anti-inflammatories.”
“There’s evidence, particularly in illnesses of the brain, that it does work,” she says. So depression, anxiety, ADHD, tourettes, PTSD, different aspects of psychosis — for those type of things the evidence consistently shows that there’s benefits. CBD is not as great with pain, she says, because you kind of need THC to get any pain benefits.
But CBD research takes money, something which scientists are notoriously short on. And ideally they’d be able to grow their own products here to research but that would take less regulation, something which governments are notoriously fond of.
So, what’s legally available in Australia?
As of 2015 CBD oil is legal in Australia, as long as it contains at least 98% cannabidiol and 2% or less of other cannabinoids found in cannabis. When compared to a lot of other countries, like the US, Canada, Japan, Germany, Switzerland, UK, Netherlands, we’re quite behind.
“Surprisingly the government — particularly the Therapeutic Goods Administration (TGA), which regulates how drugs are marketed and available to consumers — seem to be listening,” says Dr Iain.
Earlier this year the Department of Health put in a proposal for CBD to change from Schedule 4 (prescription only) to Schedule 3, which would make it available over the counter at your local pharmacy. This could happen as early as February 2021.
How do you actually get CBD oil?
“CBD got caught up in the whole medical cannabis legalisation thing that happened from late 2016,” Dr Iain explains. As part of that, there was a “torturous process” set up for Australians to access CBD, whereby you have to go through a doctor, you need to hope said doctor is educated about CBD and is in favour of its use, then you need to persuade them that CBD is right for you, then they need to write a complicated application and send that off to Canberra to the TGA who would then decide either way.
Then, of course, if you do get approved there’s the issue of cost, which is prohibitive for a lot of people. Sitting at about $10-$15 a day, “you’d probably find it’s cheaper to grow your own (and a lot of people do).”
Out of the approvals issued in total in over three years, Dr Iain estimates that about 20,000 patients gained access legally (when you take into account the prescription renewals throughout that time). “And there’s probably 10 times more people — certainly from our surveys — that are accessing illicit cannabis and self-medicating.”
‘Green Light’: New doco reveals story of two Aussies breaking the law to supply medicinal cannabis
“We try and just look at this as a health issue and as a human rights issue.”
So yeah, the government and researchers are well aware that a lot of people in Australia are opting to bypass the current system and spend their money offshore, buying online from places like Canada and the US. But there are signs that prices will go down, since obviously there’s an increasingly competitive market for it.
Already there’s countless overseas companies taking an interest in selling to Aussies. “They see it as perhaps the fastest growing market in the world, even though it’s a small population the numbers add up,” says Dr Iain.
“The main thing we need is a really vibrant domestic market. It grows particularly well in Australia — the stuff just jumps out of the ground!”
The good news in all of this, agree both experts, is that that strict regime tends to ensure high quality control of the product. “By being careful and quite well regulated the Australian scheme is probably going to give rise to very good products that will have a lot of export potential,” says Dr Iain. “The unfortunate thing is, Australian consumers are having to wait a very long time to get these products and at a reasonable price.”
Medicinal cannabis is legal, so why are people still turning to the black market?
After Grace was diagnosed with cancer, she turned to medicinal cannabis. But getting it legally was a challenge, so she’s sticking with the black market — and experts say her experience is common.
On top of that, your average over the counter product that’ll be available here will have relatively low concentrations of CBD. So, if you’re getting an oil that has maybe 30 milligrams per mil, your average daily dose is probably less than 100 milligrams of CBD. However, clinical trials and research suggest that effective doses for things like anxiety and psychosis tend to be a lot higher, they tend to be up around 500-1000 milligrams, which causes Dr Iain beg the question: “Even if we get the over the counter products available in Australia, will they actually be any good?”
Should you believe the hype?
Dr Iain says to “watch the hype.” He points to when cocaine was first invented, when they thought it would be a great cure for opium addiction and you could just chuck it in any old fizzy drink. “You always get this huge hype [around new drugs] and you do have to let research run its course. Big clinical trials take several years so complete; five years from now we’ll know a lot more about CBD and it’s potentials and limitations.”
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There’s also the placebo effect to consider, so after weeks of use the shine may wear off and the expenditure may seem less worth it.
“The hype is almost certainly wrong. The idea that it’s just a placebo is almost certainly wrong, as well. So the truth is somewhere in between. What we have to do as scientists is work out what that truth actually is.”
As a neuroscientist, Dr Katrina is particularly interested in the developing brain and the short term and long term effects of cannabidiol use on it. “A lot of people say that CBD is non-psychoactive but psychoactive is defined as something that interacts with the brain and changes behaviour. Now that applies to THC, alcohol, heroin, whatever. CBD is absolutely psychoactive, it’s just psychoactive in a good way.”
“What is concerning. as CBD becomes more available companies will inevitably jump on board to try and make a dollar out of it. This is the hype that I’m concerned about,” she says.
Especially when it comes to younger brains and an increasingly casual use of cannabis products, Dr Katrina advises: “Just remember cannabidiol is a medicine.”
“We’re saying that it’s beneficial for all of these illnesses, it’s not just a wellness substance like a vitamin C.” She recommends only taking it if you actually need to for genuine dysfunction or illness, not as a supplement, and to exercise “a little bit of caution when ordering things from overseas or using as a daily tonic”
You’ve probably met its mate, delta-9-tetrahydrocannabinol (aka THC aka the one that makes you wicked high) but what about CBD?
Down-scheduling CBD and growing Australia’s cannabis industry
TGA seeking advice from the Scheduling Committee this November 9 min read
The Therapeutics Goods Administration (TGA) is proposing amendments to the Poisons Standard which, if made, will permit pharmacists to sell low-dose cannabidiol (CBD) products to adults without a prescription.
If such products can get registered on the Australian Register of Therapeutic Goods (ARTG), this has the potential to achieve the intended effect of accelerating patient access to medicinal cannabis products in Australia and growing this high potential market. However, the current dearth of registered cannabidiol (CBD) products is a barrier which the proposed amendments may not overcome. In seeking additional advice from the Joint Advisory Committee on Medicines and Chemicals Scheduling (Scheduling Committee) this November before making its highly anticipated final decision, the TGA is attempting to bridge the divide between increasing access to CBD, and addressing the safety concerns that initially saw the Scheduling Committee recommend maintaining the status quo.
Businesses intending to import, manufacture and supply cannabis products in the Australian market should monitor these developments closely, especially given their potential impact on product development and the pre-clinical and clinical trial data required to support an ARTG application if ultimately required.
- Key takeaways
- Who is this relevant to?
- Proposed down-scheduling of CBD
- Working within the traditional framework
- Actions being taken now
- If more CBD products can achieve ARTG registration, the proposal to down-schedule CBD from Schedule 4 (prescription medicines) to Schedule 3 (pharmacist medicines) has the potential to increase patient access to CBD products.
- The Scheduling Committee initially advised the TGA that the current scheduling of CBD is appropriate, but recognised that in the absence of increasing ARTG registrations, down-scheduling CBD may not be effective to improve access to low dose CBD.
- Schedule 3 CBD products will still need to meet stringent requirements for ARTG registration, including that the product demonstrates efficacy for the indication for which registration is sought.
- Several manufacturers have raised doubts that the efficacy requirement can be satisfied in light of the low-dosage restrictions accompanying the proposal to move CBD from Schedule 4 to Schedule 3.
- Whether the down-scheduling can actually serve to increase patient access to CBD products will in part depend on whether the TGA can strike the right balance between the traditional pillars which underpin ARTG registration: safety and efficacy.
Who is this relevant to?
Australian and foreign cannabis and pharmaceutical companies seeking to enter the Australian cannabis market through the manufacture, import or supply of cannabis products.
Proposed down-scheduling of CBD
In Australia, laws permitting the cultivation, production, manufacture and research of medicinal cannabis came into effect in 2016 through a complex licence and permit framework regulated at federal, state and territory levels.
Cannabis is on Schedule 8 of the Commonwealth Poisons Standard as a controlled substance. CBD for therapeutic use is on Schedule 4 where the cannabinoid content, a group of closely related compounds, comprises ≥98% of CBD (a type of cannabinoid) and ≤ 2% of any other naturally occurring cannabinoids.
Schedule 4 CBD products are only available on prescription from an Australian-registered medical practitioner. ARTG registration is a pre-condition to prescription. This requires demonstrated evidence of clinical efficacy for the intended use, as well as safety and quality. However, with only two registered cannabis products – GW’s Pharma’s Savitex nabaximols product (for multiple sclerosis), and now GW Pharma’s Epidyolex CBD product (for seizure therapy) only just registered in September 2020 – patient access to medicinal cannabis through this pathway is extremely limited at present.
Schedule 8 unapproved cannabis products can only be accessed by the Special Access Scheme (SAS), Authorised Prescriber scheme or clinical trials. Unless the patient is seriously ill, clinicians applying for TGA permission to use the SAS pathway to prescribe medicinal cannabis must demonstrate that all options for conventional treatment have been exhausted.
CBD products should not be confused with hemp products and fibres, which are regulated at state level rather than federally, and cannabis sativa seeds used as an ingredient in foods and which are regulated by the Foods Standard.
Following a public consultation, the TGA recently released an interim decision to amend Schedule 3 of the current Poisons Standard to include low-dose CBD. If implemented, this would permit the sale of oral, oral mucosal and sublingual (under the tongue) CBD formulations to adults without a prescription which satisfy the following criteria:
- the CBD is plant derived, or when synthetic only, contains the (-) CBD enantiomer;
- the maximum recommended daily dose of the product is ≤ 60mg of CBD;
- supply is in packs containing not more than 30 days’ supply;
- the cannabinoid content comprises ≥98% CBD and ≤2% of other naturally occurring cannabinoids; and
- the product is packed in a blister or strip packaging or in a container fitted with a child-resistant closure.
Other formulations such as gels, oils or vaporised products would be excluded.
Down-scheduling CBD products which meet the above criteria from Schedule 4 to 3 removes the need for a prescription. They could be sold by a pharmacist who must assess appropriate use – similar to the sale of other Schedule 3 drugs such as Ventolin and certain cold and flu preparations.
Supply of CBD products meeting the TGA recommended criteria would still need to be registered on the ARTG and approved for a specific indication. This means they would still need to undergo a pre-market assessment of safety, efficacy and quality, and once approved must be labelled with specific warning statements and may not be advertised directly to consumers.
Registration on the ARTG is to be contrasted with listing on the ARTG. Listed medicines are assessed by the TGA for quality and safety but not efficacy. CBD products can only be eligible for listing rather than registration if CBD is included in a determination of permissible ingredients for that purpose, and presently it is not.
Working within the traditional framework
Impetus for change
A Senate Inquiry report, handed down on 26 March 2020, recognised that the current regulatory regime creates hurdles to bringing products to market and prevents patient access to medicinal cannabis in Australia. Following recommendations from the Senate Inquiry, the TGA conducted a public consultation, receiving significant interest with more than 5,400 submissions, before making its interim decision.
The TGA interim decision to down-schedule CBD was supported in some form by 80% of the 109 non-campaign submissions. The remaining campaign submissions were approximately evenly split in their support for an alternative proposal, or to de-schedule CBD altogether. While the TGA’s rationale is to increase patient access to CBD products, if implemented, this would also better align Australia more closely with its international counterparts. These include the United Kingdom, Canada, Switzerland and some states in the United States, where some CBD products are sold over the counter without a prescription
Addressing the Scheduling Committee’s concerns
In making its interim decision, the TGA had regard to the Scheduling Committee’s advice, as required under the Therapeutic Goods Act 1989. The Scheduling Committee was of the view that the current scheduling of CBD remains appropriate, citing a number of reasons including the risk that the current lack of approved indications would prevent a pharmacist being able to determine appropriate supply, and that the safety and quality of a pharmacist-compounded CBD product would be difficult to ensure or enforce.
The TGA’s interim decision introduces additional requirements which seek to address the Scheduling Committee’s concerns. Schedule 3, unlike Schedule 4 (for prescription medicines), does not mandate ARTG registration, However, a key safeguard in the TGA’s decision is that down-scheduled CBD products would still be required to be registered on the ARTG. This would ensure that such CBD products will still be assessed for safety, quality and efficacy, and that only those products which have been approved for a specific indication will be available without a prescription.
Overcoming the current barriers to increase access
Whilst the TGA’s interim decision seeks to address the Scheduling Committee’s safety concerns, it does not address the fact that a key barrier to accessing CBD products is the lack of products registered on the ARTG. This is recognised in the Senate Inquiry report.
Under Schedule 4, no dosage restrictions are presently imposed on CBD products. Under the proposed Schedule 3, a low-dose restriction would be imposed. This is based on the TGA’s safety findings that CBD presents a good safety and tolerability profile at a low-dose range of under 60mg/day and may have possible clinical utility when used via the oral route.
In the course of the TGA public consultation, some manufacturers submitted that the current lack of evidence as to the therapeutic value of CBD products at this low-dose may not satisfy the efficacy requirement for ARTG registration, and would therefore not address this key barrier which is currently preventing products coming to market.
The Scheduling Committee itself, despite advising that the current scheduling of CBD remains appropriate, noted that in the absence of registered products, down-scheduling CBD may not be effective at improving access to low dose CBD.
Other manufactures have said that the ARTG registration requirements should not be relaxed in relation to medicinal cannabis products, and support maximum dosage requirements pending further clinical evaluation before medicines are approved.
Despite diverging views, it nevertheless seems that the ARTG registration criteria – currently recognised as posing regulatory hurdles for Schedule 4 products, would not only persist in relation to Schedule 3, but could be elevated by reason of the accompanying dosage restrictions. If so, despite the TGA’s intention, down-scheduling CBD to Schedule 3 may not have the effect, or at least the immediate effect, of facilitating greater patient access to CBD products and opening the market to these consumers.
As Australia’s cannabis market is still in its infancy, this conundrum may be answered over time as the numerous clinical trials for medicinal cannabis products that are currently underway show hoped-for results, with the expectation that there will be more applications for ARTG registration, which will in time mean more products are available to patients.
Actions being taken now
The public was invited to make further comment by mid-October 2020. However, with the volume of submissions already considered by the TGA, it seems more likely that any change to the TGA’s interim decision would be on the basis of the additional advice it is now seeking from the Scheduling Committee this November on the additional restrictions around age, labelling and dosage that would accompany any down-scheduling.
The down-scheduling CBD from Schedule 4 to 3 would have the obvious advantage of permitting access to safe, low-dose CBD products without the need for a prescription. The next challenge is to have ARTG-registered CBD products available to consumers. These additional restrictions may address ongoing safety concerns, but if CBD products proposed to be sold as pharmacist medicines are limited to low-dosage formulations, they may still be out of reach to consumers. If such products cannot demonstrate the requisite degree of efficacy, they will not achieve the ARTG registration. Therefore, the down-scheduling CBD may merely create further regulatory hurdles without increasing patient access to CBD products.
Any move of CBD to Schedule 3 is expected to occur in June 2021. Businesses intending to import, manufacture and supply cannabis products in the Australian market should consider how the criteria imposed will impact product development, and the pre-clinical and clinical trial data required to support an ARTG application if ultimately required.
The TGA’s final decision will be closely monitored and we will keep you updated.
TGA guidance on the promotion of medicinal cannabis
The Therapeutic Goods Administration (TGA) has issued guidance on advertising to the public for businesses involved with medicinal cannabis products and therapies. Along with advertising restrictions, these guidelines may impact the use of cannabis-related trade marks incorporated in business names and branding despite such trade marks being registerable in Australia. Cannabis businesses should carefully navigate this tension and pay close attention to the TGA’s guidance to avoid the material risk of civil and criminal penalties arising from non-compliance.
The Therapeutics Goods Administration is proposing amendments to the Poisons Standard to permit pharmacists to sell low-dose cannabidiol (CBD) products without a prescription. Businesses intending to import, manufacture and supply cannabis products in the Australian market ought monitor this closely