The Special Access Scheme (SAS) is a program setup by the Therapeutic Goods Administration (TGA) for doctors to prescribe medications that are not listed on the Australian Register of Therapeutic Goods (ARTG). The ARTG is a list of therapeutic goods (medicines) that have been evaluated by the TGA for their “quality, safety, efficacy and performance.”
So, when doctors want to prescribe a treatment not listed in the ARTG, they must have already considered, and in some cases prescribed, all available treatments already on the ARTG.
There are three pathways that the SAS has for doctors to prescribe non-ARTG listed medications (in our case medical cannabis).
- SAS A – notification for a patient defined as seriously ill
- SAS B – application pathway
- SAS C – notification of use of specified therapeutic goods
If you intend to speak with your GP or a cannabis clinic about accessing medical cannabis, your doctor is likely to go through the SAS B – application pathway. You can read our cannabis access pathways article to learn more details about how to access cannabis in Australia.
Note: While medical devices and other medicines can be prescribed through these pathways, the remainder of this information will be focussed on cannabis.
SAS A – notification for a patient defined as seriously ill
In order for a patient to be approved for a non-ARTG listed medication through SAS A, they must be defined as seriously ill. The definition of seriously ill is:
- For medicines and biologicals (includes cannabis) – they have a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
SAS B – application pathway
SAS B is a pathway that is used when patients don’t fit into SAS A, or SAS C. Cannabis is not available under SAS C.
First a doctor must be willing to apply to prescribe medical cannabis for the condition. The doctor then must do an assessment, compile your medical history and submit an application to the TGA with the following information:
- The patient diagnosis and indication for which the cannabis product is sought.
- There must be a thorough clinical justification for the use of the product. This includes:
- The seriousness of the condition
- Details of previous treatment
- The reasons why an ARTG listed therapeutic good cannot be used for the treatment in this circumstance.
- Sufficient safety and efficacy data to support the use of the product. This can be:
- Clinical trial results and published peer-reviewed data, OR
- Evidence that the product has been approved for an equivalent indication by a national regulatory body with comparable regulatory requirements.
- Details for how the patient will be monitored for adverse events and different patient responses to the treatment.
If approved, your doctor will then need to have regular checkups with you to make sure that the medication is working as expected. If the doctor needs to change medications, a new application will need to be submitted.
SAS C – notification of use of specified therapeutic goods
Not applicable for cannabis
Further Information about cannabis & the TGA
More information about the SAS can be found on the SAS section of the TGA website.
More information about cannabis access pathways can be found on the cannabis section of the TGA website.
