Cannabidiol should remain under the guidance of doctors but exempt from the Special Access Scheme, a leading GP has said, as calls grow for a re-think on the down scheduling of low-dose CBD.
An interim decision to allow low doses to be sold without a prescription as a schedule 3 medicine was made in September, with a final ruling by the Therapeutics Goods Administration expected later this month.
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Among the key industry concerns is that the current maximum dose set by the TGA – 60mg per day – is simply too low and will restrict the ability to bring products to market.
In making its interim ruling, the TGA spelt out the need for solid data, emphasising that “only products that have been approved for a specific indication appropriate under a schedule 3 listing will be available without a prescription”.
With a paucity of clinical data for low doses, it is felt manufacturers will struggle to demonstrate efficacy and therefore be unable to list a product on the Australian Register of Therapeutic Goods (ARTG).
In its final submission to the TGA, the Medicinal Cannabis Industry Australia (MCIA) called on the TGA to raise the maximum dose from 60mg per day to 300mg, a level it insists is still safe but at which higher quality evidence exists to demonstrate efficacy.
But Dr Vicki Kotsirilos, associate professor at La Trobe and Western Sydney Universities and Australia’s first authorised prescriber of medicinal cannabis, said CBD, whatever the dose, should remain a prescription-only medicine.
However, she said GPs should be free to prescribe it without having to justify their decision.