15 June 2017

On 13 June 2017, the Senate voted to disallow the Therapeutic Goods and Other Legislation (Narcotic Drugs) Regulation 2016. The primary effect of this is that unregistered medicinal cannabis products can now be prescribed, subject to other Commonwealth and state/territory legislation, under the Special Access Scheme Category A.

This means that doctors can now prescribe unregistered medicinal cannabis products without seeking prior approval from the TGA to patients meeting the definition of a Category A patient:

  • persons who are seriously ill with 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

It is important to remember that unregistered medicinal cannabis products can continue to be prescribed under Special Access Scheme Category B and the Authorised Prescriber Scheme for patients who meet the definition of Category A.

What medicinal cannabis products can be prescribed under the Special Access Scheme Category A?

Doctors can only prescribe imported medicinal cannabis products under SAS Cat A. The Narcotic Drugs Act 1967 prevents locally cultivated and manufactured products from being used under this pathway through the operation of section 11K of that Act. This prevents a manufacturer from obtaining a licence unless they are supplying through various pathways such as clinical trials, the Special Access Scheme Category B, Authorised Prescriber and registered product.

This means that the unregistered medicinal cannabis products recently imported by the Australian Government cannot be prescribed under SAS Cat A. Their import was permitted without usual pre-import checks because the TGA was approving or authorising their use.

Access pathways to medicinal cannabis

The below table summarises how product can be accessed under the various pathways.

Product Special Access Scheme Category A Special Access Scheme Category B Authorised Prescriber Compounded in public hospital
Imported – patient by patient
Imported – under sponsored import policy
Domestically cultivated and manufactured

The Narcotic Drugs Regulations allow product compounded in a public hospital for use in that hospital. This does not require any approval from the TGA.

What does the prescribing doctor need to do?

For products to be imported under SAS Cat A, the prescribing doctor or dispensing pharmacist will need to hold an import licence from the Office of Drug Control and apply for import permission for each patient. Evidence showing that the doctor (and, if necessary, the pharmacist) holds the necessary state/territory approvals to handle medicinal cannabis products will be required, along with evidence that the product to be imported meets appropriate quality standards, including Therapeutic Goods Order 93.

The Office of Drug Control gives priority 1working day assessment times for all SAS Cat A imports. However, this cannot be guaranteed if necessary evidence of state/territory approval or the quality of the product is not provided.