Public Summary Documents Explained

The availability of Public Summary Documents (PSDs) is the result of initiatives coming out of the Australian-United States Free Trade Agreement (AUSFTA) based on transparency principles supporting the provision of information regarding the basis for the subsidy of pharmaceuticals to the Australian community, through the Pharmaceutical Benefits Scheme. PSDs will be published around 4 months after the relevant PBAC meeting. For further information please refer to the Timing of stages in the PBS Listing process.

The purpose of PSDs is to provide to the public, information pertaining to PBAC recommendations, so that stakeholders (for example doctors, health professionals and patients) are aware of the rationale for specific PBAC recommendations, and gain an improved understanding of the overall PBS listing process.

The structure of the PSD is the result of collaboration between the Australian Government and the Pharmaceutical Industry, and is aimed at providing consistent information across PBAC recommendations. The PBAC is required by legislation to take into account the cost-effectiveness of medicines proposed for subsidy compared with other therapies, therefore the PSD includes information on the economic analysis presented by the sponsor company and the PBACs evaluation of the cost effectiveness claims.

At present PSDs are only available for PBAC considerations relating to the PBS listing of medicines. PSDs are not yet available for other PBAC considerations, such as those relating to pricing arrangements for medicines already available on the PBS. This is the subject of ongoing negotiations between the government and the industry.

Technical terms are used in many of the outcomes of PBAC meeting summaries. Some of the more common technical terms are included in the

Glossary to Accompany the Guidelines for the Pharmaceutical Industry on the Preparation of Submissions to the PBAC