Health Care Practitioners (HCPs) can provide appropriate patients with access to medicinal cannabis products as an unapproved medicine through the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) or Authorised Prescriber (AP) Scheme. HCPs applying to the TGA to access medicinal cannabis products for their patients under the SAS or the AP Scheme must provide information to satisfy the criteria around the patient, product and prescriber.
TGA accepts SAS and AP applications from registered HCPs however state-based regulations may prevent some HCPs from prescribing i.e. restrict to Specialist only (check your State regulations).
Access to Medicinal Cannabis Products
SPECIAL ACCESS SCHEME (SAS)
The SAS provides a pathway for prescribers to access unapproved products (medicinal cannabis) for individual patients on a case-by-case basis. Once TGA approval has been received prescribers are required to submit state-based forms (where required). Contact details for each state regulator can be found https://www.tga.gov.au/access-medicinal-cannabis-products-using-access-schemes.
As of 30 July 2018, an online system was introduced to enable the lodgement of SAS applications and notifications through an online system. The SAS online system will allow prescribers in certain States and Territories to submit an application to both the TGA and the relevant State/Territory Health Department simultaneously (for participating states).
AUTHORISED PRESCRIBER SCHEME (AP)
The Authorised Prescriber Scheme (AP) provides a pathway for prescribers of a specified unapproved therapeutic good (medicinal cannabis) to specific patients (or classes of recipients) with a particular medical condition. Medical practitioners seeking to become Authorised Prescribers need to have their application approved by a HREC or endorsed by a specialist college.
Once approved an Authorised Prescriber is allowed to supply the product (medicinal cannabis) directly to specified patients under their immediate care and not to other practitioners who prescribe/administer the product. Use of the product under an authorisation must be at all times in line with the conditions specified in the authorisation.
Once a medical practitioner becomes an Authorised Prescriber they do not need to notify the TGA when they are prescribing the unapproved product (medicinal cannabis), however they must report to the TGA the number of patients treated on a six-monthly basis.
Patients may gain access to medicinal cannabis by participating in one of the medicinal cannabis trials running across Australia. The current trials are detailing the effectiveness of different medicinal cannabis formulations and presentations for different medical conditions.
Further information about State based access to Medicinal Cannabis can be found below: