Stage 2 PBS Process Improvements and revised cost recovery arrangements - Information Forum

Page last updated: 11 September 2020

Pending Government approval, the implementation of Stage 2 PBS process improvements is expected to commence from 1 January 2021. 

The Department of Health will host a webinar on 21 September 2020 to provide industry, consumers and clinicians with information on Stage 2 changes including the associated cost recovery arrangements.

This session will outline:

• Revised submission categories, the introduction of a single submission date and resubmission pathways
• Details of the regulation changes to support Stage 2 changes
• Details of the revised cost recovery arrangements
• Transition arrangements

The Department strongly encourages all applicants with a submission being considered at the March 2021 PBAC meeting and those submitting applications for the July 2021 PBAC meeting to attend this webinar.

This webinar builds on the previous presentations from November 2019 and February 2020, which introduced the Stage 2 process improvements and revised cost recovery arrangements.

There will be a live Question and Answer session at the end of the webinar. The webinar recording, draft Procedure Guidance, Cost Recovery Implementation Statement and transition arrangements will be available after the webinar.

Public consultation will follow the webinar – a PBS news item will notify stakeholders of the commencement of public consultation. 

Webinar Details

Date:   21 September 2020

Time:   10am to 12 noon

RSVP:   Please register to confirm your attendance.

Following the webinar, any questions can be sent to PBSImprovements@health.gov.au.

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. Changes will ensure that Australians continue to receive timely and affordable access to necessary medicines.

This webinar builds on the a series of information forums that will help to ensure industry, consumers and clinicians are up to date on PBS process improvements and associated changes.