PBS Process Improvements
Page last updated: 10 April 2019
The Pharmaceutical Benefits Scheme (PBS) listing process is highly regarded internationally and provides the Government of the day with a sound basis to make decisions with regards to subsidising medicines. Due to increasing demand there is growing pressure on existing systems which require some level of change.
On 27 April 2017, the Government signed a five year Strategic Agreement with Medicines Australia (PDF 11.MB) recognising both parties commitment to a viable medicines sector in Australia and a sustainable PBS.
Under clause 10 of the Agreement, Streamlined medicines listing processes, a number of objectives were identified to improve the efficiency, transparency and timeliness of the PBS listing processes, including:
- developing a revised pathways framework for approval by the Minister to focus resources on the more come complex PBAC Submissions and to streamline costs associated with less complex submissions;
- following review by PBAC and other stakeholders, possibly propose amendments to the PBAC meeting cycle;
- doubling of access for sponsors to early advice by increasing the timing and frequency of pre-submission meetings;
- reducing the time from PBAC recommendation to listing by an average of two months by examining processes to finalise deeds and agreements, restrictions and requirements to publication;
- facilitating online submissions of applications for listing medicines on the PBS; and
- reviewing the alignment of PBAC meeting times and regulatory processes arising from the Medicines and Medical Devices Review Implementation.
The department and industry, through the Access to Medicines Working Group – Streamlined Pathways Subgroup (AMWG-SPS) co-designed the revised pathways framework based on seven core design principles.
In August 2018, Minister Hunt approved broad consultation on proposed framework and endorsed a staged implementation approach. Details of the proposed process improvements and implementation approach are outlined in the PBS Process Improvements Fact Sheet.
In September 2018, two consultation forums were held with industry, consumers and clinicians. In October and November 2018, Medicines Australia, on behalf of the AMWG-SPS, held a further four consultation forums directly with industry. All forums were held in either Sydney or Melbourne.
Consultations indicated there is broad support for the proposals and an understanding that process improvements require associated resourcing and therefore cost recovery changes. Stakeholders advised they are keen to see the details of the improvements to better understand how the changes will work in practice. Consultations were held on 1 March and 5 April 2019 on Stage 1 PBS Process Improvements. Further consultations are planned for 2019.
For further information on the AMWG-SPS is available on the PBS website - including an outline of the activities they are undertaking and communiques on the work completed to date.
Public Consultation: 8 April to 29 April 2019
The Department of Health held a PBS Process Improvements Webinar Information Forum on 5 April to provide industry, consumers and clinicians with additional information on Stage 1 of PBS process improvements. Topics discussed include information on the Positive Recommendation Pathways and Medicine Status Website. The webinar, procedure guidance and documents are available for comment and feedback from 8 April to 29 April 2019. If you did not register for the webinar information forum before 5 April 2019 and would like to view the webinar, please register.
- Draft Positive Recommendation Pathways Procedure Guidance – (Word 142KB)
- Draft Positive Recommendation Pathways Procedure Guidance – (PDF 1.1MB)
- Draft Notice of Intent for Pricing Form (Word 78KB)Draft Notice of Intent for Pricing Form (Word 78KB)
- Draft Notice of Intent for Pricing Form (Word – Accessible version 26KB)
- Draft Medicine Status Website – Consumer View Paper (Word 98KB)
- Draft Medicine Status Website – Consumer View Paper (PDF 767KB)
Please provide your feedback through the following channels:
- Email – PBSimprovements@health.gov.au
- Hard copy – you can print a hard copy of your written comments and post to:
HTA Improvement Section
Technology Assessment and Access Division
Department of Health
GPO Box 9848,
Canberra ACT 2601, Australia
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.
- Fact Sheet - Overview of PBS Process Improvements
- Streamlining PBS Medicines Listing Processes - External Consultation – September 2018 (PDF 2.2MB) - (Word 1.5MB)
- Closed for consultation: Draft Cost Recovery Implementation Statement (CRIS) for Listing Medicines on the PBS and Designated Vaccines on the NIP (PDF 1.2MB) - (Word 120KB)