Ministerial Discretion not to apply Statutory Price Reductions

Page last updated: 28 November 2018

Changes to the National Health Act 1953 in 2018 provide for new Ministerial Discretion powers to reduce or not apply Statutory Price Reductions (SPRs) under Division 3A of Part VII of the National Health Act 1953 (the Act). These changes were introduced as part of the Strategic Agreement between the Commonwealth and Medicines Australia and are intended to allow the Minister the discretion not to apply a Statutory Price Reduction (or to reduce a Statutory Price Reduction) where a medicine has already been subject to disproportionately large price decline since 1 January 2016.

Further explanation of Ministerial Discretion can be found in The Explanatory Memorandum to the National Health Amendment (Pharmaceutical Benefits-Budget and other Measures) Bill 2017.

Requesting discretion (Anniversary Price Reductions)

Sponsors can request that a particular drug not be subject to a scheduled Anniversary Price Reduction under section 99ACF of the Act. Guidance on requesting ministerial discretion and relevant matters for determining whether discretion will be exercised can be found in the Anniversary Ministerial Discretion Guidance (PDF 130KB) - (Word 61KB).

Requests must be emailed to the PBS Statutory Price Reductions Inbox and include:

CLOSING DATE DATE OF EFFECT
27 April 2018 1 June 2018
11 December 2018 1 April 2019
1 December 2019 1 April 2020
1 December 2020 1 April 2021
1 December 2021 1 April 2022 (5% only)

Requesting discretion (First New Brand Price Reductions)

Discretion to reduce or not apply ‘First New Brand’ SPRs

Sponsors can request that a ‘First New Brand’ Statutory Price Reduction be reduced or not applied. Guidance on the operation of First New Brand SPRs and requesting ministerial discretion can be found in the 25 per cent price reduction Ministerial Discretion Guidance (PDF 44KB) - (Word 49KB).

Requests must be emailed to the PBS Statutory Price Reductions Inbox and include:

New presentation listing without triggering ‘First New Brand’ SPRs

Sponsors can request that a new presentation of a particular drug not trigger ‘First New Brand’ SPRs if listing of the new presentation is sought up to the tenth anniversary of the drug being a PBS listed drug. Guidance on the operation of the new presentation exemption can be found in the New Presentation Ministerial Discretion Guidance Material (PDF 91KB) - (Word 62KB).

Requests must be emailed to the PBS Statutory Price Reductions Inbox.