Role of the Commonwealth and state governments
The responsibility for regulating medicinal cannabis is shared between the Commonwealth and the States and Territories.
Role of the Commonwealth
In Australia, responsibility for regulating medicines and poisons is shared between the Commonwealth and the states and territories:
- Commonwealth controls what drugs may be used for therapeutic purposes
- individual state or territory regulate patient access to these drugs.
All therapeutic goods and products must be approved for use by the Commonwealth, either:
- registered on the Australian Register of Therapeutic Goods (ARTG)
- approved by the Therapeutic Goods Administration (TGA) for treatment of a particular patient or class of patient.
Most medicinal cannabis products are unapproved therapeutic goods – they have not been listed on the ARTG. Therefore, in addition to obtaining state approval to use medicinal cannabis for patient treatment, the treating doctor must obtain approval from the TGA to access the medicinal cannabis products to be used in the treatment.
Currently, medicinal cannabis products are not readily available in Australia. This means the treating doctor must also obtain customs approval from the TGA to import a suitable medicinal cannabis product from overseas.
However, as it is likely that domestically-produced medicinal cannabis products will not be listed on the ARTG, TGA approval to access the products will be required.
A drug cannot be listed on the Pharmaceutical Benefits Scheme (PBS) until it is listed on the ARTG.
Queensland approval process
The chief executive of Queensland Health reviews and approves applications to use medicinal cannabis, with the assistance of an expert advisory panel.
The Chief Executive is the Director–General of the Queensland Department of Health.
Expert advisory panel
The Queensland Medicinal Cannabis Expert Advisory Panel is appointed by the chief executive and assists them to decide applications made under the single-patient prescriber pathway by providing:
- advice for each individual case under the single patient prescriber pathway
- recommendations about the conditions and symptoms for which an approval may be granted
- the medicinal cannabis products used, including type and form
- recommendations about current or proposed research related to medicinal cannabis
The panel may also seek advice from other experts as required both nationally and internationally, for example paediatric neurologists for applications regarding children with epilepsy.
The panel are experts in the condition being reviewed; they will be able to advise that all reasonable treatment options for the disorder have been tried before using an unapproved product such as medicinal cannabis.
The panel will only communicate with the applicant i.e. the doctor when more information is required to inform their advice to the Director-General. No direct communication with the patient will be entered into by the panel.
Length of approval process
Because medicinal cannabis products are not approved therapeutic goods and have narcotic status, any decisions about treatment need to be carefully considered. Once a completed application is received it will be assessed promptly if the application is within the scope of the guidance it will generally be determined with 1 week. If the application is outside the guidance it may need to be reviewed by the expert panel this may delay the determination by a few weeks.
Under the Public Health (Medicinal Cannabis) Act 2016, the chief executive must decide an application:
If an applicant is dissatisfied with the decision of the chief executive, they can request a review. If the decision remains disputed, it can be appealed through the Queensland Civil and Administrative Tribunal (QCAT).