Fact Sheet - Overview of PBS Process Improvements
Page last updated: 7 October 2020
Background
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 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 applicants 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) collaborated on the revised pathways framework.
In August 2018, Minister Hunt approved broad consultation on proposed framework and endorsed a staged implementation approach.
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.
Further consultations were held on 1 March, 5 April 2019 and 14 June 2019 on Stage 1 PBS Process Improvements, which will be implemented incrementally from 1 July 2019. Consultation on Stage 2 PBS process changes is 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.
Implementation Outline
The first stage of process improvements commence from 1 July 2019 (for the November 2019 PBAC meeting) and include:
- Changes to pre-submission meetings to improve guidance and support higher quality complex submissions.
- Introduction of a mandatory intent to apply step for PBAC submissions.
- Introduction of transparent pricing pathways following a positive PBAC recommendation.
Stage 2 PBS process improvements will be implemented from 1 January 2021 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.
