The NSW Government is strongly committed to an evidence-based approach to the use of all medicines, including the use of cannabis-based medicines.
We are working to support appropriately qualified medical practitioners to access legal, safe and effective pharmaceutical-grade cannabis products where they consider this to be an appropriate treatment option for their patients.
State and Commonwealth legislation allows medical practitioners to apply for an authority to prescribe legally produced cannabis-based medicines that are not on the Australian Register of Therapeutic Goods, or available in Australia.
The Therapeutic Goods Administration has published the steps needed for a medical practitioner to prescribe cannabis-based medicines. More information can be found here.
Patients who believe a cannabis-based medicine may assist them should first speak to their treating doctor about whether a particular product may be an appropriate treatment option for them.
As with any controlled or emerging/experimental medicine, applications for authority to prescribe cannabis-based medicines must meet specific criteria about the product, patient and prescriber.
Currently, there are no cannabinoid-containing products legally manufactured in Australia, and very few worldwide that have been formally assessed for efficacy, safety and quality by a medicines regulator.
What approvals are required?
To prescribe a cannabis-based medicine medical practitioners must:
- apply for authority from NSW Health; and
- apply for approval from the Commonwealth Department of Health (Therapeutic Goods Administration) under either the:
Specific rules apply to children involving higher-risk medicines and investigational products. Special approvals under the Children and Young Person's Care and Protection Act 1998 may be required, depending on the substance. NSW Health manages these applications on the prescriber’s behalf.
Cannabidiol products (containing 2% or less of other cannabinoids as an impurity in the cannabidiol component) do not require authority from NSW Health. However, as there are no cannabidiol products currently on the Australian Register of Therapeutic Goods in Australia (ARTG), TGA approval is still required.
What are the eligibility criteria for a legal prescription?
Applications to prescribe a cannabis-based medicine must provide certain information and meet criteria, including:
- Evidence that standard treatments (medicine and non-medicine) known to be effective have already been tried for the patient.
- Reasons why the practitioner wants to prescribe the product and their assessment of the potential benefits and harms for the patient.
- Evidence of the suitability of the medicine to treat the patient’s particular condition or symptoms. This includes any scientific papers, guidance or position statements.
- Evidence of the quality, safety and efficacy of the proposed product. This includes information about active ingredients, the planned dose and strength to be given and the route of administration (e.g. oral spray, drops).
- How the patient will be monitored and assessed to evaluate the effect of the product and whether treatment should continue.
- How known or potential side-effects or harms will be monitored.
To be approved, the product must meet the standards for cultivation and manufacture developed by the TGA, which applies to any other medicine. This is to ensure any products are of a standardised content and purity and do not include harmful levels of contaminants. These are generally medicines that are not registered and have not undergone tests of safety or efficacy.
There are no limits on the specific conditions for which an application to prescribe a cannabis-based medicine may be made, provided the above criteria are met.
While NSW general practitioners are not excluded from being prescribers, given the uncertainty associated with prescribing unregistered products it is expected that applicants will be specialists in the field for which the relevant product is being requested or have the written support of the patient’s treating specialist.
The information requested of doctors applying to NSW Health and the TGA is similar to that requested of any doctor wishing to prescribe any unapproved medicine.
Applications are reviewed by a committee of medical experts who are physicians with experience in the assessment of new medicines for use in NSW public hospitals, in research and, more broadly, in the community. These experts provide advice to NSW Health on whether the application should be supported.
NSW Health is responsible for deciding the outcome of each application on a case-by-case basis.
In each case, careful consideration is given to the particular circumstances of the patient after reviewing all of the available evidence about treatments already attempted, the potential benefits and harms of the proposed medicine, the quality of the product and whether it is appropriate under the circumstances for the patient.