A background on down scheduling CBD oil
At the start of 2020, the Department of Health (DOH) proposed that low dose CBD products be made available over the counter at pharmacies in Australia. That recommendation was made to the Advisory Committee on Medicine Scheduling (ACMS).
Since the recommendation, the committee took public submission and reviewed those submissions and other recommendations about making CBD oil more accessible. The regulators also made their own recommendations to be taken into account.
The ACMS has come back with their first decision, their interim decision, which broadly agreed with the government’s original proposal.
Overview of the decision
The ACMS has made the following recommendations:
- Access: 18+ through a pharmacist
- Product types: oral products only – no inhalants or vape products
- Product contents: Cannabidiol (CBD) any cannabinoids, other than cannabidiol, must comprise 2 per cent or less of the total cannabinoid content.
- Manufacturing: no compounded products, Australian Register of Therapeutic Goods (ARTG) listed products only.
- Dosages: 60mg per day, 30 day packs
- Patient info: No advertising allowed – same laws as current medical cannabis
The reasons the decision is almost useless for patients and industry are covered by points 4 and 6 above.
What this means for industry and patients
Listing on the ARTG
To explain why this decision doesn’t do much for Australians we’ll briefly explain ARTG listing.
Before anyone can access CBD over the counter or without a prescription, these CBD products must be listed on the ARTG. To list, CBD manufacturers need to prove that their product is both safe and effective for treating a specific symptom or indication. This evidence is typically gathered during clinical trials which can often take years to complete.
Clinical trials have five phases in total and listing a product on the ARTG usually happens after the third phase of trials.
While this is the interim decision and there is a possibility that the burden of proof will change, in its current form, proving that CBD is effective at these doses will be almost impossible.
Advertising restrictions
For anyone who’s tried to understand the journey one must take to get medical cannabis in Australia or looked for information about medical cannabis products, you’ll know it’s almost impossible to find.
The TGA’s current advertising guidelines treat cannabis like any other pharmaceutical when, in fact, there are so many reasons that it’s not. Under the plan for down-scheduling CBD, the current advertising restrictions will remain in place. As a consumer – it will continue to be almost impossible to find information about cannabis or CBD.
What’s next? What can I do to help?
This was the interim decision. There’s now another round of public consultation. You can submit your comments to the TGA here until the end of October.
The final decision will be made in November, and any decision made in November will be implemented in law in June 2021.
Info to help with your submission of comments
Here are just a few important facts that were made public about the proposals and submissions which you may want to use in any further submission:
- The last open submission had 5409 public submissions received.
- The majority of these submissions (approx. 52%) supported an alternative proposal set out in the campaign while and just under half (46%) agreed with the private submission (government’s proposal).
What we find interesting is that if 52% supported an alternative framework and only 46% supported the government’s proposal – why did we get a decision that’s simply a replica of the private submission?
Conclusion
The positive is that the decision by the AMCS is a small step toward the recognition of cannabis as a health and wellness supplement. Unfortunately, that’s about it.
It will be interesting to see what this new submission and review period will bring. We hope to see the final decision, in November, reflect the following statement put out by the World Health Organisation, “CBD is a promising treatment for a number of medical conditions, is well tolerated, has a good safety profile, and doesn’t appear to be a risk for abuse, dependence, or other public-health related problems.”
