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News & Trends - Pharmaceuticals

PBS process improvements impacted by COVID-19

Health Industry Hub | April 29, 2020 |

Pharma News: On 12 February 2020, the Department of Health hosted a webinar to commence broad consultation on proposed fee changes for Pharmaceutical Benefits Scheme (PBS) and National Immunisation Plan (NIP) listings.

This was followed by a public consultation period from 17 February to 16 March 2020.

As outlined at the webinar and in the consultation document, Stage 2 PBS process improvements and supporting cost recovery arrangements were to be implemented from 1 July 2020, pending Government agreement.

Overview of Stage 2 PBS Process Improvements

  1. Changes to initial submission categories (including introduction of a single submission date)
  2. Introduction of resubmission pathways for submissions not recommended by the PBAC
  3. Revised cost recovery arrangements to support implementation of Stage 2 process improvements.
  4. Other improvements, including IT system changes

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The current COVID-19 pandemic may impact the government approval of Stage 2 PBS process improvements and supporting cost recovery arrangements and a 1 July 2020 implementation date is now unlikely.

As a result, applicants should be prepared for the current processes and the 2020-21 fees indicated in the 2019-20 Cost Recovery Implementation Statement (CRIS) and the Regulations, pending government approval of some minor amendments, to commence from 1 July 2020.  These proposed 2020-21 fees were included in consultations last year.

A 2020-21 CRIS, which will outline the fees to apply from 1 July 2020 will be released as soon as possible.

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