For safe access to medication in Australia, each drug is assessed for its safety and effectiveness. There are two main processes for getting drug access here. The medication must be assessed and approved by the TGA (Therapeutic Goods Administration), and then for prescription medications to be subsidised by the Government to make it affordable to users, the drug is assessed by the PBAC to assess if it is cost effective compared to other available medications. If it shows adequate benefit to patients and is cost effective, it is funded by PBS.

Therapeutic Goods Administration (TGA)

The TGA is part of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products.

This includes goods that we rely on every day, such as sunscreens, through to goods used to treat serious conditions, for example prescription medicines, vaccines, blood products and implants.

Essentially, any product for which therapeutic claims are made must be listed, registered or included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

The TGA evaluates therapeutic goods before they are marketed and monitors products once they are on the market, it also assesses the suitability of medicines and medical devices for export from Australia.

The TGA also regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. It has a team of manufacturing inspectors that audit manufacturing facilities around the world to ensure that products supplied in Australia are of high quality.

The TGA administers the Therapeutic Goods Act 1989. This legislation provides a framework for a risk management approach that allows the Australian community to have timely access to therapeutic goods which are consistently safe, effective and of high quality.

The TGA works with consumers, health professionals, industry and its international counterparts in order to effectively regulate increasingly complex products resulting from rapid scientific developments.

Pharmaceutical Benefits Scheme (PBS)

The 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:

• Drug Utilisation Sub Committee; and
• Economics Sub Committee.

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. More information can be found here: http://www.tga.gov.au/hp/access-sas.htm.