Right now, there is only one medicinal cannabis product approved by the Commonwealth Therapeutic Goods Administration (TGA) for use in Australia. That product is Nabiximols (Sativex®), which is approved for 'treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy'. A Victorian Schedule 8 Treatment Permit is required in order to prescribe Nabiximols.
Other medicinal cannabis products are considered unapproved drugs by the TGA. Doctors require special approval via the Special Access and Authorised Prescriber Schemes, in order to prescribe unapproved drugs.
All medicinal cannabis products need to be prescribed by a medical practitioner as part of an overall treatment plan.
Access to legal medicinal cannabis can only be secured through your treating doctor or specialist, if they believe medicinal cannabis will be beneficial in the treatment of your condition. It is important to remember that legal medicinal cannabis products are prescribed as pharmaceutical medicines, and so the support of your treating doctor or specialist is critical. Any decision about appropriate treatment must be made in consultation with your treating medical team.
Your medical condition and the type of medicinal cannabis product your doctor wants to treat you with will dictate which approvals they will need in order to prescribe it to you.
To gain access to legal medicinal cannabis you must:
- Discuss medicinal cannabis with your doctor. If they agree that medicinal cannabis is appropriate, they will need to identify the medicinal cannabis product they want to prescribe to you.
- Remember that your doctor or specialist will need to organise appropriate approvals for the medicinal cannabis product. These approvals may include applications to the Commonwealth Therapeutic Goods Administration and the Victorian Department of Health and Human Services. If the product your doctor wants to prescribe is not already in Australia, they may also need to apply to the Commonwealth Office of Drug Control to import the product.
- Be aware that you will only be able to access the product after your doctor has all of the required approvals to prescribe the medicinal cannabis product to you.
Fact sheet: Access to medicinal cannabis in Victoria - Information for patients and carers.
Prescribing of medicinal cannabis products follows the same requirements as all other pharmaceutical medicines.
If a product is registered on the Australian Register of Therapeutic Goods (ARTG), then it can be prescribed as per usual prescribing processes.
If the medicinal cannabis product is not an approved product, then approval from the Therapeutic Goods Administration (TGA) is required to prescribe using unapproved medicines pathways (the Special Access Scheme and the Authorised Prescriber Scheme).
Irrespective of whether the medicinal cannabis product is registered on the ARTG or not, if the medicinal cannabis product is a schedule 8 controlled drug then a Victorian Schedule 8 treatment permit is required.
Schedule 4 medicinal cannabis products, which are pure cannabidiol preparations containing 2 percent or less of cannabinoids other than cannabidiol, do not require a Victorian treatment permit.
For further information on the scheduling of products, please refer to the poisons standard.
Any medical practitioner can apply to prescribe medicinal cannabis products using the above access pathways. Note that for access via the TGA's unapproved medicines pathways, evidence of specialist support for the treatment may be required.
ARTG Listed Products
There is currently only one medicinal cannabis product, Nabiximols (Sativex®), listed on the ARTG as a schedule 8 controlled drug.
The approved indication for Nabiximols (Sativex®) is:
'Treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.'
A Victorian Schedule 8 Treatment permit is required in order to prescribe Nabiximols (Sativex®), however no further Commonwealth approvals are needed.
Unapproved medicinal cannabis
Access to other medicinal cannabis products is the same as for any unapproved drug, which is via the TGA Special Access or Authorised Prescriber Schemes. Patients may also be able to access medicinal cannabis products as part of registered clinical trials.
Depending on the drug sought, it may also be necessary to apply for a treatment permit under the Victorian Drugs, Poisons and Controlled Substances Act 1981. Currently, treatment permits are required for any Schedule 8 medication, which in the case of medicinal cannabis products, are any products that contain more than two per cent tetrahydrocannabinol (THC).
Fact sheet: Access to medicinal cannabis in Victoria - Information for medical professionals.
The Office of Drug Control (ODC) publishes an updated list of importers and manufacturers of medicinal cannabis products on its website, which may assist in identifying products currently available in Australia. It is important to note that these products can currently only be accessed via Special Access Scheme Category B.
It is possible to prescribe a medicinal cannabis product not already in Australia, however, appropriate import permits issued by the ODC will also be required.
Accessing medicinal cannabis
There are two points that must be confirmed prior to progressing applications for medicinal cannabis access; how is the drug scheduled, and what special access scheme category is relevant to the patient.
The way the intended drug is scheduled within the Poisons Standard will impact the pathway to approval.
Cannabidiol in preparations for therapeutic use containing two per cent or less of other cannabinoids found in cannabis are Schedule 4 drugs. Cannabidiol content must be 98 per cent of total cannabinoid content - eg. A Cannabidiol to 'other cannabinoid' ratio of 49:1).
Any cannabis product that is listed in Schedule 8 of the Poisons Standard for human therapeutic use is a Schedule 8 drug.
This advice is provided as general guidance only. It is important to review the Poisons Standard to confirm the Schedule of the specific drug you intend to prescribe.
Special access scheme
Import and/or supply of an unapproved therapeutic good for a single patient requires TGA approval via the Special Access Scheme (SAS).
Under the SAS, patients are grouped into either Category A or Category B.
Category A patients are defined as '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'.
Category B patients are all other patients that do not fit the Category A definition.
This advice is provided as general guidance only. It is important to review the Therapeutic Goods Administration website to confirm eligibility requirements.
If the product you intend to prescribe is a Schedule 8 drug, you will also be required to hold an appropriate Victorian treatment permit. Schedule 8 drugs have the strictest legislative controls of all commonly available medicines.