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.
The Commonwealth Government passed amendments to the Narcotic Drugs Act 1967 (Cwth) to establish a legislative scheme for the domestic cultivation, production and manufacture of medicinal cannabis for research and therapeutic purposes. Under the Commonwealth scheme, licenced businesses will develop the capacity to cultivate and manufacture medicinal cannabis in Australia.
Therefore, in future, patients allowed to receive treatment with medicinal cannabis may be able to access suitable medicinal cannabis products produced within Australia to a high standard set by the TGA.
Only products that meet these standards will be considered for prescription by doctors. All other cannabis products will remain illegal.