Medicinal Cannabis - Information for Prescribers in Tasmania

NOTE: This information is effective from 1 July 2021

Scheduling and registration of medicinal cannabis products

Regulation of medicinal cannabis products follows the same regulatory process as for all other medicines and includes both Commonwealth and State legislation and frameworks.

Medicinal cannabis products are scheduled in the Commonwealth Poisons Standard. Applicable controls depending on the schedule of the products are applied in Tasmania under the Poisons Act 1971 and Poisons Regulations 2018.

Most medicines prescribed in Australia have been approved by the Therapeutic Goods Administration (TGA) to be included on the Australian Register of Therapeutic Goods (ARTG).  Medicines are only listed on the ARTG when the TGA is satisfied with the medicine’s evidence of quality, safety and efficacy.   Medicines that the TGA has either not assessed, or that have insufficient evidence of quality, safety and efficacy are known as ‘unregistered’ medicines.

Who can prescribe medicinal cannabis?

In Tasmania, a registered medical practitioner can prescribe unregistered medicinal cannabis to a patient if they believe it is clinically appropriate and have obtained all required Commonwealth and / or State approvals and authorisations.

For a Schedule 8 medicinal cannabis product to be legally dispensed by a pharmacy in Tasmania, the medical practitioner must also be present and practicing in Tasmania when issuing the prescription.

What approvals are required?

Prescribing medicinal cannabis follows the same regulatory process as for all other medicines.

If a Schedule 4 or Schedule 8 medicinal cannabis product is not registered in the ARTG it cannot legally be supplied in Australia, unless approval has been gained under either the SAS or AP Scheme as administered by the TGA.

An authorisation under Section 59E of the Tasmanian Poisons Act 1971 is required prior to issuing a prescription for a Schedule 8 medicinal cannabis product. Section 59E authorisation is required for each individual patient. No authorisation under the Poisons Act 1971 is required to prescribe a Schedule 4 medicinal cannabis product.

Where applicable, prescribers can apply for both Tasmanian and TGA approvals for unregistered medicinal cannabis products concurrently through the TGA’s single online application form.

Table 1: Summary of approvals required before prescribing a medicinal cannabis product

Product type

Commonwealth approval (SAS or AP scheme)

Tasmanian authorisation for patient under Section 59E of the Poisons Act 1971

Unregistered Schedule 8 medicinal cannabis product (ie not registered on ARTG)

Required

Required

Registered Schedule 8 medicinal cannabis product

Not required

Required

Unregistered Schedule 4 medicinal cannabis product (ie not registered on ARTG)

Required

Not required

Registered Schedule 4 medicinal cannabis product

Not required

Not required


Application process

For unregistered medicinal cannabis products, a single web-based application process is available to obtain approval from both the Commonwealth and the Tasmanian Department of Health (only for Schedule 8 products). Decisions are advised by email within two business days, provided all required information has been provided by the applicant.

To access the online application portal please visit: https://compliance.health.gov.au/sas/

Where a TGA registered Schedule 8 medicinal cannabis product exists (i.e. no TGA SAS or AP approval required), for authorisation to prescribe under Section 59E of the Poisons Act 1971 prescribers must apply directly to the Tasmanian Department of Health using an approved Section 59E application form.

Before applying the medical practitioner should identify the medicinal cannabis product they have selected as appropriate for the patient and clinical condition.

What medical conditions are eligible?

There is no list of eligible medical conditions. The prescriber is responsible for reviewing the available clinical evidence for medicinal cannabis and making an informed risk-benefit assessment with respect to their patient’s individual clinical circumstances prior to making an application to prescribe an unregistered medicinal cannabis product.

Clinical decisions about whether treatment with an unregistered medicinal cannabis product is suitable for a particular patient remains a matter for the treating medical practitioner.

Clinical evidence

High-quality peer-reviewed scientific literature supporting the use of medicinal cannabis to treat a range of conditions is limited. The role of medicinal cannabis will become clearer as additional research is published and the evidence base expands.

The TGA has developed a series of clinical guidance documents to assist doctors and patients to understand the evidence for the potential uses of medicinal cannabis.

These guidance documents have been based on evidence reviews conducted by the National Drug and Alcohol Research Centre (NDARC) and can be accessed via the TGA website.

Prescriptions for unregistered medicinal cannabis products

Once a prescriber has obtained the required Commonwealth SAS or AP approval, and Tasmanian authorisation (for Schedule 8 products), they may issue the patient a prescription for the unregistered medicinal cannabis product. The prescription must comply with the established legal requirements of the Poisons Act 1971 and Poisons Regulations 2018 which will differ depending on the schedule of the product.

The prescription may be legally dispensed at any pharmacy in Tasmania. For an unregistered medicinal cannabis product the prescriber will need to supply the pharmacy with a copy of the TGA approval so that the wholesaler can release the product to the pharmacy.

What medicinal cannabis products are available in Australia?

Information on medicines and products which have been entered by the TGA into the ARTG is available from the TGA webpage.

At present, most medicinal cannabis products available in Australia are unregistered. Unregistered medicinal cannabis are required to comply with the TGA Standard for Medicinal Cannabis (TGO 93) to be supplied in Australia. This standard is about minimum manufacturing quality requirements and is not about clinical effectiveness or risk of adverse events.

The Commonwealth Office of Drug Control (ODC) licenses businesses that import medicinal cannabis products and Australian based manufacturers. Prescribers may obtain information about available products, formulations, strengths and dosing directly from manufacturers and importers. A list of licensed suppliers is available from the ODC website.

What is the cost of medicinal cannabis products?

Unregistered medicinal cannabis products are not subsidised by the Commonwealth Pharmaceutical Benefits Scheme (PBS). This means the patient is responsible for funding the cost of treatment. The cost will vary depending on the prescribed product and regimen, and cost is set by manufacturers and importers. Prescribers should contact suppliers directly for information on product prices.

Specialist medical practitioners within the Tasmanian Health Service (THS) may utilise existing THS application pathways for subsidised medicines access to high-cost and highly specialised medicines.

Importation by health practitioners

Health practitioners can import medicinal cannabis products from overseas for the treatment of individual patients. However, in addition to the approvals and authorisations required by the TGA and Tasmanian Department of Health, importation must also be approved by the ODC. Please see the ODC website for more information.

Medicinal cannabis and driving

Medicinal cannabis can cause impairment and affect fitness to drive, and a person who drives a vehicle while under the influence of a drug to the extent that the person is incapable of having proper control of the vehicle is guilty of an offence (even if the drug is prescribed). It is recommended that patients do not drive whilst being treated with unregistered medicinal cannabis.

THC (tetrahydrocannabinol) is the main psychoactive substance in cannabis and is present in some medicinal cannabis products. Driving with any detectable amount of THC in your system is an offence in Tasmania, unless the product was obtained and administered in accordance with the Poisons Act 1971.