Australia’s Therapeutic Goods Administration approved 57,781 SAS (Special Access Scheme) Category B applications for unapproved medicinal cannabis products in 2020.
It was a huge year given the TGA has only approved 85,000 SAS Category B applications since this medicinal cannabis pathway was established way back in 1992. Here’s how 2020 shaped up for approvals for each month according to the TGA.
- January – 3148
- February – 3568
- March – 3926
- April – 3378
- May – 4133
- June – 4630
- July – 5564
- August – 5270
- September – 6206
- October – 5972
- November – 6356
- December – 5630
It should be noted approval numbers don’t reflect the number of patients receiving these medicines under the SAS as multiple approvals can be attributed to a single patient, and some patients may discontinue use of medicinal cannabis products.
While the uptick in approvals is encouraging, something concerning is a reported continuing lack of supply and exorbitant costs associated with prescription products. MCUA president Deb Lynch says most of the product grown in Australia is being exported, contributing to supply issues.
Others say Christmas demand has delayed supply, with some products completely sold out. And it’s not just a matter of patients switching to another strain or type of product as prescriptions are product-specific. To make the switch, a new prescription needs to be acquired along with a new approval from the TGA.
Looking ahead, it will be interesting to see how the TGA’s decision to make certain CBD medicines available without a prescription from February 1 will impact on the number of approvals in 2021. However, while low-dose cannabidiol will be available under Schedule 3 (Pharmacist Only) from February, it remains to be seen if any products will be listed on the Australian Register of Therapeutic Goods (ARTG) from the get-go; which is a requirement. Also, the maximum recommended daily dose will be 150mg and many patients prescribed cannabidiol are taking much higher doses, so may continue to need to access prescription medicines.
Still, this is all progress; although for Australians who are impacted by supply and cost issues, that’s little comfort and further reforms can’t come soon enough.