This is a guest post from Cannabis Law Review and Tom Brown of honahlee.
CBD: Schedule 4 to Schedule 3 Drug
Recently, the Australian Department of Health announced a proposal to down schedule low-dose CBD to a Schedule 3 drug. This change would mean low-dose CBD would be available for sale in pharmacies.
In order to understand what this possible change means for the Australian consumer, we interviewed Rhys Cohen, a cannabis expert, and the Principal Consultant at FreshLeaf Analytics. The following article has been adapted from our interview with Rhys.
In the interview, Rhys answered the following questions:
Rhys Cohen’s cannabis industry experience:
Rhys’ involvement in the cannabis industry dates back to 2015.. He wrote his honours thesis on cannabis legalization in the US. Since writing his thesis, Rhy spent time as the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney; he’s become the Director of Cannabis Consulting Australia, he participates in medical cannabis education and is now the Principal Consultant at FreshLeaf Analytics.
FreshLeaf Analytics is a strategic consulting and market intelligence company that services the medical cannabis industry. The company operates in Australia and works with both local and international clients.
FreshLeaf helps companies figure out what’s going on in medical cannabis. They help identify advantages or potential risks and help companies to make better strategic decisions about launching products or building on the success of their existing product ranges.
FreshLeaf also publishes a quarterly cannabis industry reports which help give insights into the cannabis landscape for patients and the general public.
What triggered the review on CBD re-scheduling?
The Australian CBD market is drastically different from those overseas, particularly the USA and Canada. Part of the reason rescheduling CBD is being explored is because of increasing interest and demand, globally, for access to these sorts of products without a prescription.
Also, community demands for better access to cannabis products in general is increasing.
The news about rescheduling came from a submission by the Department of Health to start an inquiry into barriers to patient access. This inquiry may be a political choice made to demonstrate that the government is taking action to improve access to medical cannabis in Australia.
Australia has made a lot of progress since 2016 when our legal framework came into effect. This is an extension of that framework.
What types of CBD would the rescheduling cover?
The proposed Schedule III entry has the same definition as the current Schedule IV entry of CBD.
The current Schedule IV entry says, “CBD for human therapeutic use,” so not for animals, not for recreation, but for human therapeutic use.
To be considered a Schedule IV or a Schedule III CBD product, 98% of the cannabinoid content needs to be CBD alone. That tends to rule out a lot of the less refined or more crude extracts or products.
So, the rescheduling would likely cover products under the isolate or distillate category.
What does rescheduling CBD actually mean?
At the moment, CBD is a Schedule IV drug. The proposal is not to remove or change that definition, but to create a new supplementary definition. The change means that low dose CBD will be available behind the counter through a pharmacist, for minor ailments.
For more serious medical conditions, epilepsy for example, you will still need to see a doctor or specialist to get a prescription for a higher dose CBD.
The proposal is to create an additional entry at Schedule III, which is a pharmacist only medication. These are products that you can access from a pharmacy, but only by speaking with the pharmacist. They’re not available on the shelves. Some examples of Schedule III drugs are sleeping pills and certain cold and flu medications.
What doses would be available?
The proposal would allow specific low doses of CBD to be made available behind the counter for minor medical conditions. The government has recommended a maximum of 60 milligrams per day for this low-dose CBD category.
They would recommend that only 30-days worth of supply be included in a packet of medication, so about 1,800 milligrams per pack, 60 milligrams per daily dose.
Will individuals or any company be able to sell CBD?
If the new scheduling comes into effect, it will work as follows:
February 1st, next year, the changes are implemented and there would be a Schedule III entry for low-dose CBD.
Before companies will be able to sell those products to consumers through pharmacies, they’ll need to get their specific drug registered on the Australia Register of Therapeutic Goods (ARTG). Companies will need to have a well-designed, well characterised product that’s stable and meets all the quality requirements.
They’ll also need to prove, using clinical data, that their product is effective in treating a specific medical indication or symptom. The company will need to submit all of that information to the TGA to get its product assessed and hopefully registered on the ARTG.
Registration on the ARTG can be quite a challenge even for big companies to pursue.
Challenges of ARTG Listing
There are quite a few unanswered questions about the ability to register.
Is it commercially viable for a company to pursue that strategy? Is pure CBD, at 60 milligrams a day, going to show efficacy in treating a specific condition or symptom?
Then we have questions around evidence. What level of evidence might be required? Will companies need full-blown, costly and time-consuming randomised, placebo-control trials to demonstrate that CBD is effective? Or, would observational data be acceptable? Could people make literature-based submissions, based on information that’s already in the public domain?
These are some of the questionsFreshLeaf is going to be working through with clients over the coming months.
It’s still unclear if this rescheduling is actually going to result in genuine access to these products, or if it will just be one step closer but with much more work needed to be done.
Could the draft proposal be different from the final outcome?
Yes, the current draft is not the only outcome that is possible.
There’s a long consultation process that needs to be followed. This proposal has been sent to the Advisory Committee on Medicines Scheduling (ACMS), which is a group of people within the Department of Health who make these decisions.
Currently, the rescheduling is now open for public consultation. The advisory committee is inviting members of the public to make submissions to them about whether or not they support this change or what they would rather it look like.
After receiving the public recommendations, the AMCS will review and produce an interim decision, and then there will be a second round of public consultations on that interim decision.
Because it’s quite a long process with multiple review points, it’s possible the outcome could change. Some possible changes are daily dose limit changes or fewer or additional restrictions imposed. We’ll have to wait and see what the final outcome is.
When would the new regulations officially begin?
If the changes are implemented:
Effective as of the 1st of February 2021.
At schedule III, what conditions could you buy CBD to treat?
Pharmacist only medicines are not intended to treat serious medical conditions. If you have severe pediatric epilepsy, for example, a very serious medical condition for which CBD is occasionally prescribed, you wouldn’t be accessing those products via your pharmacist. You would still need to access higher dose CBD from your GP or specialist via prescription.
Over-the-counter or behind-the-counter medications are available for minor conditions, for example:
- mild anxiety
- mild insomnia
- mild pain
Again, not for the treatment of chronic and severe conditions.
Are there reasons the proposal would not be passed?
The advisory committee needs to consider several issues around public safety. They’ll ask questions like:
- Will this be safe?
- Will this meet a clinical requirement of some kind?
- Is this going to be good for people?
- Also, will this have any unintended impact on the community?
- Is there a potential for people to become dependent on products?
- Is there a potential for side effects or any other kinds of adverse events?
These are the considerations the committee is taking into account when making these decisions. Rhys went on to say:
“The Department of Health reviewed the safety literature on CBD. They came to the conclusion that based on all of the available data, low dose CBD seems pretty safe for pharmacists to dispense. So, I don’t see the advisory committee having additional concerns around safety or side effects.”
How can I help? How do I make a submission?
We are encouraging anyone who feels strongly about safe access to CBD to make a submission. The TGA website (link in step 1 below) has information about how to make a submission. The same page also lists the current regulations, the proposed changes, reasons for the regulations and more.
In order to make it easier for you, we have submission information right here:
- Read the proposed amendment thoroughly
- Download the TGA Consultation Submission Coversheet.
- Write up your submission which must:
- Be relevant to the proposed amendment;
- Address matters mentioned in section 52E of the Therapeutic Goods Act 1989;
- Be submitted by the closing date of 22 May 2020
- Send your submission to the Dept of Health:
- Send your submission, including cover sheet to firstname.lastname@example.org
- Please include ‘Proposed Amendments to the Poisons Standard (Medicines/Chemicals)‘ in the subject line of the email
In the next section of this article, we give you some ideas of what a strong submission may include.
What information can I put into my submission
Submissions can include:
- Discussions around how this might impact you personally, both with regards to your health and/or your business and your business interests.
- You can also provide an informed opinion about whether you think this is safe or not, whether you think that the daily dose limits are appropriate or not.
- You can discuss your thoughts around the safety of these products or the risks that you might perceive.
It’s important that you are clear about:
- Do you support the amendment – yes or no?
- Suggestions or improvements that you may have.
- If explaining the impact of the proposed changes on you or your business, please attempt to quantify those costs or benefits.
Tips for making a strong submission
Rhys Cohen is well versed in drug policy in Australia. When asked for tips on making a strong submission he said this:
I know that there’s widespread use of CBD products in Australia and around the world already, not done legally. People are frequently using products that are not regulated, that meet no quality standard requirements, and there are some serious concerns around that.
Surveys in the UK have shown that many of the products available for retail sale in supermarkets in the UK don’t contain what’s on the label. Some contain no CBD, some contain twice as much or half as much as they say on the label. Some contain THC and some have unsafe levels of alcohol. This is an unregulated health product market, and it is concerning.
I would assume that a lot of Australians are already purchasing CBD products, probably online, from these websites, and maybe they don’t even realize that they’re breaking the law. Maybe they think they’re buying something that’s legal and safe and well-regulated, but they’re really not.
If you are taking a CBD product at the moment that isn’t prescribed by a doctor, you’re taking an unregulated and illegal product. If you feel like you should have better access to a legal and regulated product instead, then I would encourage you to voice that to the Department of Health.