The cannabidiol (CBD) medicine market in Australia is set to grow. At present, there are no medicinal CBD products registered on the Australian Register of Therapeutic Goods (ARTG) for supply in Australia (although some are listed for export only). Only one other medicinal cannabis product (having nabiximols as its active ingredients) is registered on the ARTG for supply in Australia.
CBD products, and medicinal cannabis products more broadly, that are not registered on the ARTG may currently only be accessed through special statutory schemes for unregistered medicines administered by the Therapeutic Goods Administration (TGA), or a clinical trial involving a medicinal cannabis product. Currently, the Australian Government does not reimburse the supply of any medicinal cannabis products through the Pharmaceutical Benefits Scheme (PBS), the Australian government’s system for subsidising most commonly used medicines.
However, this may be set to change with the Pharmaceutical Benefits Advisory Committee (PBAC) considering at its next meeting in July a submission to list on the PBS Emerge Health Pty Ltd’s Epidyolex®, a drug having CBD as its active ingredient. Although this drug is not currently registered on the ARTG, the submission to the PBAC indicates that ARTG registration is pending and that the drug is planned for supply in the Australian market.
If registered on the ARTG and listed on the PBS, Epidyolex® will be the first CBD-containing drug to be supplied in Australia, and the first medicinal cannabis product, the supply of which is reimbursed by the Australian Government.
This latest development follows on the heels of the TGA’s recent proposal to permit over-the-counter sales of low dose CBD products. You can read more about this proposal in our post ‘Australia considers over-the-counter CBD’.
The PBAC agenda primarily consists of applications relating to the new listing of a drug or vaccine on the PBS or the National Immunisation Program.