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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:

Approval

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.

Access

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.

Chief executive

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 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

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 and determined within two business days.

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).

Last updated: 1 March 2017