Authorised Prescriber & Special Access Scheme(SAS)
There are circumstances where patients may require access to medicines or medical devices which have not been approved for supply by the Therapeutic Goods Administration (TGA). A medical practitioner may apply to become an Authorised Prescriber of a specified therapeutic good (or class of unapproved therapeutic goods) to specific patients (or class of recipients) with a particular medical condition.
Medical practitioners wishing to become Authorised Prescribers must have their application endorsed by an Ethics Committee.
Updates to the Authorised Prescriber scheme
On 24 July 2020, the TGA implemented a change to the Authorised Prescriber scheme to streamline the application process for medicines considered to have an established history of use in Australia.
This change removes the requirement for Human Research Ethics Committee (HREC) approval or specialist college endorsement to be submitted to the TGA in circumstances where the medical practitioner is applying to become an Authorised Prescriber of medicines specified in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990. A list of medicines with an established history of use is available here. HREC or institutional approval may still be required to use certain ‘unapproved’ therapeutic goods within an institution. Please liaise with the Research Ethics and Governace Office to confirm the requirements.
Special Access Scheme (SAS)
The SAS scheme allows for the import and supply of an unapproved therapeutic good for a single patient, on a case by case basis. Three pathways exist under the scheme, which can be utilised by health practitioners, as follows:
Category A is a notification pathway which can only be accessed by medical practitioners for patients 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 is an application pathway which can be accessed by health practitioners for patients that do not fit the Category A definition and where the unapproved good is not deemed to have an established history of use and cannot therefore be accessed through Category C. An approval letter from TGA is required before the good may be accessed.
Category C is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The TGA website specifies these goods, along with their indications and the type of health practitioner authorised to supply them.
More information is provided by the TGA at https://www.tga.gov.au/form/special-access-scheme.