Cannabis-based products

Both the Commonwealth government and the states and territories regulate medicinal cannabis.

The Commonwealth Office of Drug Control (ODC) (external site) administers a regulatory scheme to allow cultivation of cannabis for use in medicines, manufacture of medicinal cannabis products within Australia and importation of medicinal cannabis products from overseas.

The Commonwealth Therapeutic Goods Administration (TGA) regulates medicinal cannabis products as therapeutic goods. Most medicinal cannabis products are not currently registered as therapeutic goods. This means these products can only be supplied in accordance with the TGA’s schemes for unregistered therapeutic goods, such as the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme (external site).

Nationally, most medicinal cannabis products are classified as Schedule 8 (S8) medicines (controlled drugs). These products must be treated in the same way as other S8 medicines for all aspects of supply including: prescribing, dispensing, packaging, labelling, storage, transport, recording, reporting, disposal and advertising.

Some medicinal cannabis products only contain the non-psychoactive cannabinoid, cannabidiol (CBD). These products are classified as Schedule 4 (S4) medicines (prescription only medicines). The Poisons Standard (external site) allows “cannabidiol only” medicinal cannabis products to also contain very low levels of tetrahydrocannabinol (THC) – up to 2 percent of the total cannabinoid content.

In Western Australia (WA), the prescribing and supply of all medicinal cannabis products must comply with the Medicines and Poisons legislation, in the same way as other S4 and S8 medicines. All cannabis for medicinal use must be prescribed by a medical practitioner.

Recreational cannabis remains illegal. This also means any cannabis based product that is not legally sourced and not being used for legitimate medical or research purposes is classified as illicit cannabis. There are significant penalties for possession and supply of illicit cannabis under the Misuse of Drug Act 1981, administered by the police.

Typically, medicinal cannabis products supplied in Australia are oral liquids (including oils) or capsules. Products fall into three main categories: cannabidiol (CBD) only products, products with a 50:50 mix of CBD and tetrahydrocannabinol (THC) and products with a predominance of THC. Labelled cannabinoid content is usually expressed as a ratio of THC to CBD content based on the mg/mL concentration of each cannabinoid. For example, a 20:5 product would contain 20 mg/mL THC and 5 mg/mL CBD.

As medicinal cannabis products are not TGA registered, the usual type of product information may not be available. Manufacturers and importers should be contacted to obtain information about their products, including proposed indications, formulation details and dosing recommendations. Information provided by product sponsors may not have been independently reviewed.

Although medicinal cannabis products have not been fully assessed by the TGA, these products are required to comply with the Standard for Medicinal Cannabis (TGO 93) (external site). This Standard is about minimum manufacturing quality requirements. The Standard is not about clinical effectiveness or risk of adverse events (side-effects) and is not equivalent to standards used for registered therapeutic goods. All medicinal cannabis products used in Australia must comply with this Standard, regardless of whether they are imported or manufactured locally.

The ODC licenses businesses that import medicinal cannabis products and Australian based manufacturers. A list of licensed manufacturers and importers (external site) is available on the ODC website. This list includes suppliers based in WA.

The Department of Health does not endorse any particular medicinal cannabis product or supplier.

While there is some scientific literature supporting the use of cannabis based products in selected conditions, the evidence is limited and of variable quality.

The TGA has published detailed information about current scientific evidence (external site) for medicinal cannabis in treating multiple sclerosis, palliative care patients, epilepsy in paediatric and young adult patients, nausea and vomiting and chronic non-cancer pain.

Cannabis based products can result in a number of short term adverse effects including drowsiness, dizziness, dry mouth, nausea, fatigue, disorientation and hallucinations.

No studies have evaluated long-term side-effects.

NPS MedicineWise have published information on medicinal cannabis products (external site). 

The Royal Australian College of General Practitioners (RACGP) has published a Position Statement (external site) about the use of medicinal cannabis products.

Driving and medicinal cannabis

There is potential for any medicinal cannabis product to impair attention and concentration, which may affect a person’s fitness to drive and operate machinery.

It is recommended that patients do not drive whilst being treated with medicinal cannabis.

Drug driving offences, including those related to detection of THC in saliva, are applicable regardless of whether the person is under treatment with prescribed medicinal cannabis or has used illicit cannabis.

All medical practitioners in WA are eligible to prescribe medicinal cannabis products. For most patients, a general practitioner may initiate treatment. For some patients, including those with a history of drug dependency, children and young adults, the support of a suitable specialist will be required. Details of prescribing requirements are available in the Schedule 8 Medicines Prescribing Code (Word 370KB).

Before prescribing medicinal cannabis in Schedule 8, authorisation is required from the Department of Health, for each individual patient.

There are no requirements for Department of Health authorisation for cannabidiol only products in Schedule 4. However, as these products are unapproved therapeutic goods, TGA requirements must still be met.

How to apply to prescribe cannabis based products (other than Sativex®)

Apply for approval to prescribe (external site).

A single web-based application (external site) is available to apply for Western Australian Department of Health authorisation whilst simultaneously complying with the TGA requirements. Turnaround time for approval is generally 48 hours (two business days).

How to apply to prescribe Sativex®

As at November 2019, the only cannabis based product on the Australian Register of Therapeutic Goods (ARTG) (external site) is Sativex®.

To obtain authorisation to prescribe this product, medical practitioners should apply directly to the Department of Health, using the Application for authorisation form: cannabis based products (Word 870KB).

Clinical trial use

The use of cannabis based products in legitimate medical research is permitted. Clinical trials must be approved by a recognised Human Research Ethics Committee (HREC) and be conducted under the TGA CTN or CTX Scheme (external site).

Medical practitioners can prescribe for patients entered in clinical trials by applying to become an approved prescriber (Word 61KB). Contact the Medicines and Poisons Regulation Branch for further information.

TGA Authorised Prescribers

TGA Authorised Prescribers (external site), can obtain corresponding authorisation from the Department of Health to prescribe for all their patients. Contact the Medicines and Poisons Regulation Branch for more information.

Patient consent

Due to the unapproved nature of medicinal cannabis products and limited information about safety and efficacy, the prescriber is strongly advised to obtain informed patient consent prior to treatment with these products, and to ensure appropriate levels of monitoring are in place. A Cannabis-Based Treatment consent form (Word 793KB) is available for this purpose.

Prescriptions written by WA based medical practitioners, for medicinal cannabis products, can be dispensed at any pharmacy in WA.

Pharmacies can obtain medicinal cannabis products from licensed suppliers, such as those listed on the ODC website (external site). Pharmacies are required to store medicinal cannabis products and maintain supply records in the same way as for other Schedule 4 and Schedule 8 medicines.

View the Guide for pharmacists dispensing medicinal cannabis (Word 360KB).

Cost

The price of medicinal cannabis products is not regulated by Government. Medicinal cannabis products are not subsidised under the Pharmaceutical Benefits Scheme (PBS). Only TGA approved therapeutic goods can be funded by the PBS.

Prescriptions must be dispensed as private prescriptions. Costs vary from one product to another. Suppliers and pharmacies should be able to provide details of expected costs.

Public hospitals

Hospitals will have policies relating to the use of unregistered therapeutic goods, which will likely also be applicable to cannabis based products. Any drug formulary restrictions on prescribing or funding of supply at a hospital are additional to those required by legislation. Hospital based practitioners should seek advice from their own institution regarding  restrictions on prescribing medicinal cannabis products for hospital patients.

Importation from overseas by health practitioners

Health practitioners can import cannabis based products from overseas for the treatment of individual patients. However, importation must be approved by the Office of Drug Control (external site).

Patients cannot import medicinal cannabis products for their own use. This includes products that contain THC and products that contain cannabidiol only (often described as CBD Oil).