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 as they have not been listed on the ARTG. Therefore, the treating doctor must obtain approval from the TGA to access the medicinal cannabis products to be used in a patients’ treatment.
In Queensland, if the doctor is a non-specialist medical practitioner, (note specialists includes GP’s registered with the FRACGP) they will also require a state approval to use schedule 8 medicinal cannabis products for a patients’ treatment.
A Queensland approval is also required for those special cases where the patient is considered a drug dependent person and is seeking access to schedule 8 medicinal cannabis.
Currently, medicinal cannabis products are not readily available in Australia. This may mean the treating doctor must also obtain customs approval from the TGA to import a suitable medicinal cannabis product from overseas.
It is likely that domestically-produced medicinal cannabis products will not be listed on the ARTG, therefore 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, where a state-based approval is required.
The Chief Executive is the Director-General of the Queensland Department of Health.
Length of approval process
Because most 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 and can generally be determined within 2 business days.
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).