PBAC Outcomes Explained

The Pharmaceutical Benefits Advisory Committee (PBAC) helps decide whether and, if so, how medicines should be subsidised in Australia. It considers submissions in this context. These submissions are of two types:

  • to seek listing of a medicine on the Pharmaceutical Benefits Scheme (PBS); or
  • to change the circumstances through which a medicine is already listed.

Each submission results in one of three outcomes.

1. The PBAC can decide to recommend that:

  • the medicine be listed on the PBS; or
  • the circumstances through which a medicine is already listed be changed.

Each recommendation is made to Government. There are other processes that need to be completed before the Government takes a final decision to implement any PBAC recommendation.

2. The PBAC can decide not to recommend that:

  • the medicine be listed on the PBS; or
  • the circumstances through which a medicine is already listed be changed.

The Government cannot list a medicine on the PBS without a PBAC recommendation to do so. A PBAC decision not to recommend listing or not to recommend changing a listing does not represent a final PBAC view about the merits of the medicine and is subject to review whenever a new submission is lodged.

3. The PBAC can defer a decision pending the provision of specific additional information that would be relevant and important to its decision.

'PBAC recommendations are in accordance with the indications approved by the Therapeutic Goods Administration, but may not include all such indications.'


PBAC Outcomes Information for Pharmaceutical Companies

An open letter to pharmaceutical companies (June 2003) and a Guide on the arrangements for the release of the outcomes from the Pharmaceutical Benefits Advisory Committee (PBAC)

PDF Printable version PBAC Outcomes Information for Pharmaceutical Companies (PDF 63 KB)

An open letter to pharmaceutical companies

We are pleased to advise you of recent developments improving the transparency of decisions taken by the Pharmaceutical Benefits Advisory Committee (PBAC). Work has been underway between the Pharmaceutical Benefits Branch (PBB) of the Department of Health and Ageing and Medicines Australia (MA) since it was announced by the Government last year that it wished to improve the reporting of PBAC decisions.

Decisions of PBAC have long been reported on the PBAC website if they are recommendations for listing. We have been much less informative when a decision has been taken to either defer or reject an application for PBS subsidy from a sponsor. The decision by Government of last year on transparency of PBAC processes requires us to report on all decisions from the meeting of PBAC being held in June 2003 onward. A code of conduct governing the implementation of this Government decision is at Attachment 1.

It has been agreed that the information provided relating to PBAC’s recommendations will be structured. It will be a process that is refined over the next year or so as we work out improved ways to make the reporting most useful, constructive and reasonable from the point of view of all stakeholders.

The information released provides the outcome of each application to the PBAC and a summary of the reasons for each outcome. Details of the process and timing for making public the outcomes of the June 2003 PBAC meeting are at Attachment 2. Agreement has been reached that each sponsor will receive a draft of the proposed publication of the outcome of its application, with an opportunity to comment on the content, before finalisation. On this first occasion, 15 working days will be allowed to enable agreement but, in future, 10 working days will be allowed. At Attachment 3 are the formats and wording for this process developed to date.

Agreement has also been reached that the each sponsor will have the opportunity to provide a summary comment in response to each outcome (pertaining to each submission), on the PBS website. If a sponsor wants to link the reader to its own website where further information is available, this will also be permitted. Each sponsor will have discretion about whether to include a comment or not and whether or not to provide a website link.

Transparency in the PBAC processes is a high priority issue for the Department, for Medicines Australia and for Government. There have been reasonable concerns that greater explanation could be provided on how decisions are come to relating to the PBS subsidy and it is time that we made new efforts to ensure a good understanding of our system. The PBS system is one to be proud of. It is evidence-based, it is informed by the work of many experts and it is a growing and important priority within the government’s commitment to the health and care of the Australian community.

It is agreed between PBB and MA that we will continue to work together through the implementation of these new arrangements and make changes as required. The rules are not hard and fast at this stage but rather a good operationalised form of guidelines for us to adopt.

We trust that you will welcome this development and assist us with its implementation over the coming months.

Joan Corbett
Assistant Secretary
Pharmaceutical Benefits Branch
20 June 2003

Kieran Schneemann
Chief Executive Officer
Medicines Australia
20 June 2003