There has been a lot of publicity about changes to medicinal cannabis laws in Australia, but how are cannabis products legally accessed?
Cannabis based products are not included on the Australian Register of Therapeutic Goods, so they are considered ‘unregistered medicines’ and can only be prescribed if certain conditions are met.
Firstly, to be available in Australia, a product must be legally produced. This means that the product will either be imported from a legal supply source overseas according to the Customs (Prohibited Imports) Regulations 1956 or, in due course, lawfully produced in Australia under the amended Narcotic Drugs Act 1967.
Secondly, the product can only be prescribed legally through regulatory pathways for unregistered medicines. At the Federal level, unless a patient is part of a clinical trial, access to medicinal cannabis is either via the Authorised Prescriber route or, more commonly via a specialist doctor through the Special Access Scheme (SAS).
An Authorised Prescriber can prescribe medicinal cannabis for a group of patients with the same condition. However the medical practitioner must seek endorsement for their application from an ethics committee who will assess not only the safety of the cannabis product for the condition, but also the suitability of the medical practitioner. They must also report to the TGA the number of patients treated every 6 months.
A quicker more common route, therefore is the Special Access Scheme.
The SAS refers to arrangements which provide for the import and/or supply of an unapproved therapeutic product for a single patient or small group of patients. Under the scheme, there are two categories of patients:
- Category A (SAS A)– Defined as ‘persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.’
- Category B (SAS B) – All other patients that do not fit the Category A definition.’
Recent amendments have, in effect negated Category A where a doctor just had to inform the TGA that they were treating the patient with an unapproved medication.
The SAS Category B requires a specialist doctor to obtain approval from the TGA for each patient prior to prescription of medicinal cannabis and this approval lasts for a defined period of time.
If the doctor wants to prescribe medicinal cannabis with any THC content, it is classified as Schedule 8, a Controlled Drug and they must then obtain state based approval. This can be done following TGA approval or in parallel.
Approval forms can be downloaded from the TGA or the CannabisAccess medical cannabis portal may be used for online submissions.
Previoulsy, State approval was required for some medicinal cannabis products however as of April 13 2018 the TGA has streamlined the process to required only federal government approvals.