PBS Process Improvements
Page last updated: 17 February 2020
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.
On 12 February 2020, a webinar was held to commence consultation on proposed cost recovery arrangements which, pending final government approvals, would apply from 1 July 2020.
If you were unable to watch the webinar live, please register to view the on demand recording and access the resource documents.
Please review the below consultation papers and submit your comments and feedback to the implementation team via email (PBSimprovements@health.gov.au) by COB Monday, 16 March 2020.
- Consultation paper – Listing of Medicines on the PBS and designated vaccines on the NIP – Fees and Charges Proposal 2020-21 (PDF 514KB) - (Word 185KB)
Stage 1 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
The Cost Recovery Implementation Statement and Cost Recovery Administration Guidelines are available on the Cost Recovery web page.
Overview of Stage 2 PBS Process Improvements
- Pending Government agreement, Stage 2 PBS process improvements and supporting cost recovery arrangements will be implemented from 1 July 2020.
- Stage 2 process improvements apply to submissions requiring consideration by the PBAC and include:
- 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 IT system changes
Overview of Transparency Measures
Standardised Redaction of Public Summary Documents (PSDs)
The department and Medicines Australia have been working closely through the Access to Medicines Working Group – Streamlined Pathways Subgroup since November 2018 to develop a collaborative approach to support improving transparency as defined by the PBAC.
At the May 2019 intra-cycle meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) outlined the committed to its decision-making deliberations being as transparent as possible. Its preference is that Public Summary Documents (PSDs) should not have any redactions, and asked that greater transparency is introduced in PSDs as soon as possible. The PBAC also noted further consultation with the pharmaceutical industry is needed. To date there have been three webinars on the standardised redaction changes for PSDs and the department has committed to conducting one restricted and two public trial processes.
See the Public Summary Documents – Implementation Timeline (Word 39KB) for more information on implementation of the changes to PSDs.
Medicine Status Website (MSW)
The purpose of the Medicine Status Website (MSW) is to provide the consumers, clinicians and other interest 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 public launch of the MSW is subject to government approval and further details will be available as soon as possible.
- Fact Sheet - Overview of PBS Process Improvements
- PBS Process Improvement Stage 1 Information Forum (Webinar) – 14 June 2019
- Frequently Asked Questions (FAQ’s)
- Health Products Portal (HPP) Program
- Cost Recovery Fees and Charges from 1 July 2019
- Summary of Industry Feedback regarding Stage 1 PBS Process Improvements (Word 39KB)
- Public Summary Documents – Implementation Timeline
If you have any questions regarding the PBS Process Improvements, please contact the implementation team via email (PBSimprovements@health.gov.au).
Information regarding future consultations will be sent via PBS News notifications, if you would like to receive email notification from PBS News and updated publications you can subscribe via the PBS website.