PBS (Pharmaceutical Benefits Scheme)
The Pharmaceutical Benefits Scheme (PBS) gives all Australian residents and eligible overseas visitors access to prescription medicine in a way that is affordable, reliable and timely. Through the PBS, the Australian Government subsidises the cost of listed prescription medicine, making it more affordable for all Australians
PBAC (Pharmaceutical Benefits Advisory Committee)
The PBAC is an independent expert body appointed by the Australian Government. Members include doctors, health professionals, health economists and consumer representatives. Its primary role is to recommend new medicines for listing on the PBS. No new medicine can be listed unless the committee makes a positive recommendation. The PBAC meets three times a year, usually in March, July and November. When recommending a medicine for listing, the PBAC takes into account the medical conditions for which the medicine was registered for use in Australia, its clinical effectiveness, safety and cost-effectiveness (‘value for money’) compared with other treatments. PBAC has two sub-committees to assist with analysis and advice in these areas:
Contact details for the PBAC can be found in PBS Contacts
Agendas, outcomes and public summary documents of PBAC meetings can be found under elements of the listing process //www.pbs.gov.au/info/industry/listing/participants/pbac
Medication Special Access Schemes
Most therapeutic goods are required to undergo an evaluation for quality safety and efficacy and be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.
In recognition that there are circumstances where patients need access to therapeutic goods that are not on the ARTG, the TGA manages the Special Access Scheme (SAS)
The SAS refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. Patients are grouped into two categories under the scheme:
- Category A patients are 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 patients are all other patients that do not fit the Category A definition.
With the exception of drugs of abuse where the manufacture, possession, sale or use is prohibited by State or Territory law; any unapproved therapeutic good can potentially be supplied via the SAS at a cost.