Standardised redactions to Public Summary Documents – nominations open for participation in the final trial, and implementation from July 2020
Page last updated: 5 March 2020
March 2020 trial of standardised redactions to PSDs
The Department is now seeking nominations from sponsors with submissions due to be considered at the March 2020 PBAC meeting, to participate in the final trial of standardised redactions to public summary documents (PSDs).
Participation in the final trial will allow sponsors the opportunity to provide feedback to the Department on the usability and completeness of the information and guidance provided in the Procedure Guidance and supporting documents. It will not be an opportunity for sponsors to provide feedback to change the scope or intention of the proposed redaction criteria and ranges, which have previously been consulted on and are being addressed through the first two trials.
To nominate for participation in the trial, please send an email to the PBS Process Improvements Section by COB 14th April. Further details, including a trial outline, will be provided to participants in May.
Implementation
All sponsors are reminded that the changes to the process and standardised redaction criteria will be implemented formally from July 2020.
While the Procedure Guidance and redaction criteria are being reviewed and finalised based on feedback following the July and November 2019 trial (still currently underway), the draft version of the Procedure Guidance is available on the PBS Improvements web page. The scope of the criteria are not likely to tighten as a result of the trials and so the draft version may be used as a guide for what will be applied from July 2020.
The final Procedure Guidance, including the redaction criteria, will be published in April 2020.
Background
In April 2017, the Government made a commitment to streamline PBS listing processes under clause 10.3 of the Strategic Agreement with Medicines Australia. The Strategic Agreement includes the overarching commitment to ‘improve the transparency, efficiency and timeliness of PBS processes’ and to ‘through consultation, explore other areas for improvement to PBS listing processes’.
The PBAC has indicated its preference for greater transparency to be introduced in PSDs through a standardised approach to redactions. Standardised redaction of PSDs fits within the Strategic Agreement commitments and is being delivered under the PBS Process Improvements project.
The Department has consulted on the proposed standardisation of redactions to PSDs with industry, Medicines Australia and through the Access to Medicines Working Groups - Streamlined Pathways Subgroup and the Transparency and Efficiencies subgroup.
Two webinars with industry and other stakeholders were held (July 2019 and November 2019) to explain the intended changes and to provide an opportunity for feedback on the redaction criteria.
As a result of the consultations and feedback received from stakeholders, the implementation timeline was reviewed and subsequently delayed. Process and redaction criteria changes proposed to be implemented from November 2019 and March 2020 were deferred to July 2020, and a program of three trials was also developed to provide an opportunity for sponsors to work through the proposed changes using real-world examples.
The November 2019 trial is still underway and outcomes will be made public via a webinar in the coming weeks. The final March trial is currently accepting nominations for participation via email to the PBS Process Improvements Section.
