Medicinal Cannabis Application Approvals In Australia – Update

Medicinal cannabis applications in Australia
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Australia’s Therapeutic Goods Administration (TGA) has provided some updated figures on medical cannabis applications it has approved.

The country’s Special Access Scheme (SAS) enables suitably authorised health practitioners to access therapeutic goods for a single patient such as medicinal cannabis that are not included in the Australian Register of Therapeutic Goods (ARTG). These are considered “unapproved” therapeutic goods.

Medical cannabis tends to fall into Category B of the SAS.  Category B is an application pathway accessible by health practitioners if the patient does not fit the Category A definition (facing premature death) and if the therapeutic good is not authorised for supply under the SAS Category C notification pathway (goods that are deemed to have an established history of use).

Here’s how the figures for approved Category B medical cannabis applications the TGA approved stack up for the last year:

  • March 2019: 1,023
  • April 2019 1,108
  • May 2019 1,370
  • June 2019 1,566
  • July 2019 2,207
  • August 2019 2,889
  • September 2019 2,910
  • October 2019 3,592
  • November 2019 3,403
  • December 2019 3,678
  • January 2020 3,148
  • February 2020 3,568
  • March 2020 3,926

Up to the end of March, TGA had approved over 38,600 SAS Category B applications for unapproved medicinal cannabis products – that’s since 1992.

The TGA notes it has approved applications for the treatment/management of conditions including:

  • chemotherapy-induced nausea and vomiting
  • refractory (uncontrolled) paediatric epilepsy
  • palliative (end of life) care
  • pain associated with cancer
  • neuropathic pain
  • spasticity associated with neurological conditions
  • anorexia and cachexia (wasting) associated with a chronic illness such as cancer

The TGA is quick to note that just because a patient may have one of these conditions, it does not mean an application on their behalf will be approved. It also mentions the above is not an exhaustive list of indications – applications have been approved for other conditions.

It’s good to see more approvals happening, but it would only be the tip of potential demand. On a related note, we recently reported on the recommendations coming out of wide-ranging Senate inquiry into medicinal cannabis access issues in Australia.

Further information about the Special Access Scheme, click here.