The medicinal cannabis industry has formed a dedicated committee to contest the current plan for downscheduling CBD, citing concerns that the move will fail to enhance access to meaningful therapeutic medicines for patients.
The Medicinal Cannabis Industry Association (MCIA) established a policy group sub-committee focused on CBD rescheduling to prevent the downscheduling plan from backfiring.
The Therapeutic Goods Administration (TGA) has outlined an application proposing that low-dose CBD, specified as 60mg per day for up to 30 days, be moved to schedule 3 of the Poisons Standard, which would permit availability through pharmacies without requiring a prescription.
Industry participants worry, however, that this approach is merely a political convenience that may generate confusion while offering minimal practical value to patients.
Although the Advisory Committee on Chemicals Scheduling (ACCS) and Advisory Committee on Medicines Scheduling (ACMS) have already convened to examine the downscheduling proposal, the newly formed committee plans to maintain pressure on behalf of industry stakeholders.
The proposal has been characterized as potentially a “red herring”, with several executives expressing concerns about the requirements to prove efficacy at such minimal dosages.
According to MCIA chairman Peter Crock, the TGA's selection of an 'arbitrary' upper limit may reflect the fact that the dosage demonstrates safety.
"But it might also have no effect," he said. "It might be safe but are they just approving another high-cost supplement?
"Our concern is that this could be a classic example of a potential quick fix by the regulator.
"The MCIA put in a submission but it was clear more work was needed which is why we set up a sub-committee to address it directly.
"The policy group is pushing back and saying 'hang on, what you are saying here doesn't necessarily make sense'.
"Without lambasting the regulator we want to provide a clear voice from the industry that while we support the idea of rescheduling, it must be done on the right basis and doesn't leave us high and dry."
“At the end of the day this is not going to improve access for patients. In fact, it will just muddy the water.”
MCIA chairman peter crock
Industry participants are also concerned about the narrative surrounding the downscheduling, particularly how the Government and Department of Health may promote the measure as evidence of relaxed medicinal cannabis rules that improve patient access.
However, TGA regulations require that all schedule 3 medicines undergo registration with the Australia Register of Therapeutic Goods (ARTG) and must demonstrate effectiveness.
Companies will need to spend approximately two years developing evidence of effectiveness to satisfy this requirement, according to Crock.
"The day CBD is down scheduled products will be not be available from a pharmacist because to register as a S3 medicine you still need all the background work the TGA expects," he said.
"The Government will be able to say it has taken action on CBD, and suggest it's the industry that hasn't caught up. It's important we are able to respond to that.
"This down scheduling sounds good but it doesn't mean it's going to accelerate access for patents. We'd be far better off having it available under schedule 4 through the Special Access Scheme where people can continue to access it.
"That would be better than the TGA saying 'we have down scheduled it, where is the product development?'
"At the end of the day this is not going to improve access for patients at all. If fact it will just muddy the water."
An interim decision on the application will be released on September 9, to be followed by additional consultation before a final determination is announced in November.
