Implementation of Stage 2 PBS Process Improvements from 1 January 2021

Page last updated: 7 October 2020

As announced by Government in the 2020-21 Budget, Stage 2 PBS process improvements will commence from 1 January 2021.

Stage 2 changes will include:

• Changes to 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 IT system changes.

On the 21 September 2020, the department hosted a webinar to provide information to industry on the Stage 2 PBS process improvements and cost recovery arrangements. Public consultation is now open and will close on Monday 12 October 2020.

Please refer to the PBS Process Improvements page for the consultation documents and Stage 2 Fact Sheet. 

Further updates to the PBS website will be rolled out over the next few months.

Background

The Australian Government signed a five-year strategic agreement with Medicines Australia committing to a viable medicines sector in Australia and a sustainable PBS.

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.

Improved processes and revised cost recovery arrangements support the Government’s commitment under the strategic agreement to improve the transparency, timeliness and efficiency of the Pharmaceutical Benefits Scheme (PBS) listing processes. Once implemented, changes will ensure that Australians continue to receive timely and affordable access to necessary medicines.