PBS Process Improvements

Page last updated: 21 December 2020

Background

The Department of Health and Medicines Australia have been working since late 2017 to deliver on commitments to streamline medicines listing processes and revise cost recovery arrangements as set out under clause 10 of the Strategic Agreement.

The department and industry, through the Access to Medicines Working Group – Streamlined Pathways Subgroup (AMWG-SPS) collaborated on the revised pathways framework. In August 2018, Minister Hunt approved broad consultation on proposed framework and endorsed a staged implementation approach.

Stage 1 PBS Process Improvements commenced 1 July 2019

  • Changes to pre-submission meetings to provide additional guidance and support for complex submissions.
  • Introduction of a compulsory intent to apply step for Major and Minor submissions.
  • Introduction of four new transparent pathways following a positive PBAC recommendation.

Stage 2 PBS Process Improvements commencing 1 January 2021

  • Changes to initial submission categories (including introduction of a single submission date).
  • Introduction of resubmission pathways for submissions not recommended by the PBAC.
  • Revised cost recovery arrangements to support implementation of Stage 2 process improvements.
  • Other improvements, including expansion of the department’s Health Products Portal functionality.

There are revised Procedure Guidance and new forms to support these process improvements.

The Cost Recovery Implementation Statement and Cost Recovery Administration Guidelines are available on the Cost Recovery web page.

Overview of Transparency Measures

Standardised Redaction of Public Summary Documents (PSDs)

Following extensive consultation over a period of more than 18 months, including a comprehensive three phase pilot program, changes to standardise the publication of information in PSDs have been implemented.

In July 2020, the PBAC issued a Statement of Endorsement of the changes to PSDs, which is publicly available. 

All submissions considered from and including the November 2020 PBAC meeting are subject to the revised process and criteria as outlined in the Procedure Guidance for listing medicines on the Pharmaceutical Benefits Scheme (Procedure Guidance). A supporting guidance document is also available at Appendix B of the Procedure Guidance.

Medicine Status Website (MSW)

The purpose of the Medicine Status Website (MSW) is to provide the consumers, clinicians and other interested parties with a one-stop shop for information on a medicine’s progress through the PBS listing process. It has been designed collaboratively with consumers, industry and the wider public.

Key objectives of the MSW are to:

  • Centralise the key information currently available on the PBS website,
  • Clearly articulate the window for consumer input prior to a PBAC meeting, and
  • Provide additional transparency on the steps and progress within the post PBAC phase of the process.

The Medicine Status Website was launched on 1 February 2020. More information is available on the MSW Factsheet.

Resources

Contact Us

If you have any questions regarding the PBS Process Improvements, please contact the PBS Process Improvements Section via: PBSimprovements@health.gov.au.