Access to Medical Cannabis In Australia
This information is for health practitioners who wish to access therapeutic goods that are not in the Australian Register of Therapeutic Goods (ARTG) and are not otherwise exempt from being in the ARTG. We describe these therapeutic goods as 'unapproved'. Those using unapproved therapeutic goods have responsibilities, which include adhering to relevant standards of good medical practice.
If you need to access an unapproved therapeutic good for your patient then you may use the Special Access Scheme (SAS). SAS is intended for exceptional clinical circumstances.
Approved TGA indications for medicinal cannabis include
Chronic Pain | Anxiety | Depression | Neuropathic Pain | Multiple Sclerosis MS| PTSD | Migrane | IBS | Cancer Pain | Palliative Care | Epilepsy | Chemotherapy-induced Nausea and Vomiting | Fibromyalgia | Spasticity from Neurological Conditions | Anorexia and Wasting Associated with Chronic Illness (such as cancer) and more as research assists the Therapeutic Goods Administration.
Cannabis Access in Australia
A step by step guide for patients in Australia
Access to medical cannabis in Australia
Medical cannabis in Australia is almost universally classified as an unapproved product and is not a registered prescription medicine. Despite this, patients can still access unregistered medicinal cannabis products via the following three access pathways:
Special access scheme (SAS)
Special Access Scheme (SAS) Category B is the most common and quickest pathway a medical practitioner can take to prescribe a medicinal cannabis product to a single patient. This document focuses on this process only. Practitioners can contact MOCA directly to discuss other options such as Authorised Prescriber pathway.
Medical cannabis is not a first line treatment
Before you consider this treatment option, you should be aware that the Therapeutic Goods Administration (TGA) advises medical cannabis is not a first line treatment. This means cannabinoid therapy can only be used after standard treatments have been unsuccessful or caused unacceptable adverse effects, except in the case of patients in palliative care.
Step by step guide: How to access to medical cannabis in Australia
STEP 1: Doctor consultation
It is recommended as a first step patients see their usual treating doctor, GP or specialist.
Please note: this needs to be an Australian-registered medical practitioner with appropriate qualifications and/or expertise for the condition requiring treatment e.g. for a patient suffering from Chronic pain, in most states your GP or specialist with expertise in treating this condition can make an application.
Your current treating medical practitioner should have a good understanding of your medical conditions AND access to your medical records (these records may need to be submitted if an application is made to the TGA).
STEP 2: Product consideration
If your medical practitioner decides that cannabinoid therapy is an appropriate treatment they will then need to determine exactly which product is suitable. They are likely to consider the following;
product availability by supplier;
the ongoing costs to patient; and
if it is a ‘Schedule 4’ medicine (Prescription Only) or ‘Schedule 8’ medicine (Controlled Drug) as the approval process and product delivery can differ between the two.
Product choice is the responsibility of the doctor and they’ll research and compare products to find which best fits your condition and circumstances. TGA applications require documentation confirming the product meets the safety and quality requirements set out in Therapeutic Goods Order No 93 (TGO93).
Product Information (PI)
Detailed product information, including the price of products, is available only to medical practitioners and can be obtained by contacting MOCA directly
STEP 3: Application to TGA and State Health
With a patient’s consent, practitioners can apply for federal and state approval via the SAS B pathway mentioned earlier.
In order to apply for access to medical cannabis a medical practitioner to will need to meet the TGA’s requirements and:
have confirmed your medical condition and relevant medical history,
submit documentation outlining which medications for your condition have been prescribed and are not working or have adverse effects,
submit a treatment plan and monitoring plan.
Who can apply?
This varies depending on the state/territory. In most states, a GP can initiate an application when they have expertise in the area for which the medication is being prescribed e.g. pain. In some other states, like in WA, GPs can apply but currently require a letter of support from a specialist. In most state’s specialist support is required if a practitioner does not have the relevant expertise or qualification to treat the patient’s condition (for example paediatric epilepsy).
SAS B applications will ask if the medical practitioner making the application is the patient’s usual doctor.
It is preferable for patients to be prescribed medical cannabis by their regular medical practitioner.
STEP 4: TGA Approval
Under current legislation if you are located in NSW, Victoria, Queensland, WA, SA or NT, upon receiving combined TGA & State approval a practitioner can then prescribe medicinal cannabis to the patient.
For Schedule 8 medicines, in the ACT and Tasmania practitioners must take a second step to obtain prescribing approval which is to submit a second application to the state health department.
STEP 5: Separate State / Territory Approval (for Tasmania)
Each Australian State and Territory has different requirements for patients accessing medical cannabis depending on which schedule listing the medical cannabis products are classified under (Schedule 4 or 8).
Schedule 8: Upon approval from the TGA, the doctor will receive an approval certificate that must be provided as part of a separate application to the relevant State Health Department.
Schedule 4: no State Health Department approvals are required.
STEP 6: Patient access
Upon approval from both TGA and State Health Department, a patient will receive their script and approvals for medical cannabis which needs to be presented at their choice of pharmacy. The relevant Health Department approvals will need to be sent to the wholesaler by the pharmacy. Wholesalers then release their prescribed product to the pharmacy who will dispense this to the patient. Hospital pharmacies may supply for in-patients on a copy of a medication chart order.
Please note: A pharmacist can dispense product to a patient only on receipt of an original prescription, as well as a copy of the TGA and State Health approvals (if relevant).
Want to know more?
For information on the next steps and how to talk to your doctor, or alternatives options if your doctor is hesitant to prescribe, please visit the page ‘Are doctors for medical cannabis?’