The Commonwealth Government's medicinal cannabis policy now allows doctors to prescribe medicinal cannabis products to their patients.
Prescribing medicinal cannabis products follows the same requirements as all other pharmaceutical medicines, but the process will vary depending the type of product, whether it is an approved medicine registered on the Australian Register of Therapeutic Goods (ARTG), and the patient category.
As most medicinal cannabis products are not approved, before prescribing, a doctor will generally be required to gain approval from the Therapeutic Goods Administration (TGA) through either the TGA's Special Access Scheme (SAS), or by becoming an Authorised Prescriber (AP).
Learn more about prescribing medicinal cannabis.
Currently, there is only one medicinal cannabis product, namely, Nabiximols (Sativex®) registered by the TGA for use in Australia which is approved for treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS). No Commonwealth or State approvals will be required for doctors prescribing Sativex to palliative care patients from 1 October 2018.
If the medicinal cannabis product is also a schedule 8 controlled drug, then a Victorian Schedule 8 treatment permit will also usually be required. However, no schedule 8 treatment permit is required for patients that are classified as receiving palliative care.
Victorian Treatment Permit for Schedule 8 medicines
Medicinal cannabis products are mostly classified as either Schedule 8 or Schedule 4 on the Australian Standard, referred as Poisons Standard.
For Schedule 8 medicinal cannabis products, a treatment permit from the Victorian Department of Health and Human Services (DHHS) will be required (unless the patient is classified as a receiving palliative care) in addition to the TGA's SAS or AP approval.
When prescribing an unapproved medicinal cannabis product, doctors can concurrently apply for both a Schedule 8 treatment permit and SAS approval through the SAS online system.
Product Availability and Supply
A list of Australian licensed manufacturers, suppliers and products available can be found on the Office of Drug Control (ODC) website.
If the medicinal cannabis product is not on the current ODC suppliers and products list, doctors should ensure the sponsor (pharmacist or supplier) is prepared to source it for them from overseas. If the sponsor wishes to import the product, it must hold an ODC import licence.
If doctors wish to directly import a specific medicinal cannabis product for their patients, they will need to identify the overseas suppliers and directly apply for an import licences and permits from the ODC to bring the products into Victoria.
Medicinal cannabis products are not listed on the Pharmaceutical Benefits Scheme (PBS). Annual treatment costs must be met by the patient or a third party. Information regarding the cost of products may be obtained directly from the suppliers listed on the ODC website.
Once the relevant Commonwealth and Victorian approvals are obtained, the doctor will be able to prescribe the medicinal cannabis product to the patient.
Page last updated: 11 January 2019