Pharmaceutical submission guidelines to be reviewed

The Minister for Health Sussan Ley has announced a review of the PBAC's submission guidelines to ensure Australians continue to have affordable and timely access to new medicines and products.

Page last updated: 27 April 2015

PDF printable version of Pharmaceutical submission guidelines to be reviewed (PDF 298 KB)

25 April 2015

The Minister for Health Sussan Ley today announced a review of the Pharmaceutical Benefits Advisory Committee’s (PBAC) submission guidelines to ensure Australians continue to have affordable and timely access to new medicines and products.

Ms Ley said the guidelines are used by the pharmaceutical industry to prepare submissions to the PBAC so it can assess whether a product should be included on the Pharmaceutical Benefits Scheme (PBS).

“This review demonstrates a proactive approach from the Pharmaceutical Benefits Advisory Committee to ensure the guidelines remain appropriate,” Ms Ley said.

“It is particularly timely given emerging technologies and international calls for Governments to subsidise drugs based on changing evidence, as is the case with cancer drugs.”

Ms Ley said the PBAC guidelines were regularly reviewed to make sure the submission and assessment process remains consistent and transparent. while incorporating international best practice and removing any unnecessary regulatory burden on the pharmaceutical industry.

“The PBAC Guidelines help ensure Australians have access to safe, clinically proven and cost effective medicines as soon as possible,” Ms Ley said.

“The Guidelines incorporate international best practice and remove any unnecessary regulatory burden on the pharmaceutical industry while safeguarding the sustainability of the PBS so it can benefit future generations.

“We welcome the PBAC’s decision to review the Guidelines and maintain Australia’s standing as a world leader in health technology assessment.”

The Abbott Government is committed to maintaining the independence of the PBAC and improving the listing of drugs on the PBS.

The review will be supported by Australian and international experts to ensure that the Guidelines are of the highest quality.

The Health Department is calling for tenders to conduct this review. Further information on the Guidelines is available on the PBS website.

ENDS

Minister Ley’s Media Contact: James Murphy – 0478 333 974

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