A dedicated committee has been established to “push back” against the current down scheduling plan for CBD amid ongoing fears it will do little to make meaningful medicines more accessible for patients.
The policy group sub-committee on CBD rescheduling has been created by the Medicinal Cannabis Industry Association (MCIA) to ensure the plan does not backfire.
Under an application outlined by the Therapeutic Goods Administration (TGA), low-dose CBD – defined as 60mg per day for a maximum of 30 days – will be downgraded to schedule 3 of the Poisons Standard, making it available without prescription from pharmacies.
But there is concern it could be a political “quick fix” that creates confusion and provides little benefit to patients.
While a meeting of the Advisory Committee on Chemicals Scheduling (ACCS) and Advisory Committee on Medicines Scheduling (ACMS) has already taken place to discuss the down scheduling, the committee will continue to press home industry concern.
The move has already been described as a potential “red herring”, with several executives voicing concern over the requirements to prove efficacy at such low doses.
MCIA chairman Peter Crock suggested the TGA may have set an “arbitrary” maximum dosage because it is shown to be safe.
“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.”
Among industry concern is how the down scheduling will be portrayed by the Government, with some believing it will enable the Department of Health to present the move as a further relaxation of medicinal cannabis regulations that provides improved access for patients.
Yet under tight TGA regulations, all schedule 3 medicines must be registered on the Australia Register of Therapeutic Goods (ARTG) and, critically, must be proven to work.
That will force companies to spend two years developing a data set to determine efficacy, Crock said.
“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 is expected to be made public on September 9 after which further consultations will take place ahead of a final ruling in November.