Strategic Agreements with the Medicines Industry

Page last updated: 7 September 2021

The Commonwealth has entered into new Strategic Agreements with Medicines Australia and the Generic and Biosimilar Medicines Association (GBMA), continuing its close partnership with Australia’s medicines industry.

This partnership is crucial to access to life saving and lifechanging medicines, vaccines, and other novel therapies.  

The new agreements contain a comprehensive package of reforms to ensure that Australians continue to gain access to break-through new medicines as early as possible and to deliver robust and uninterrupted supply of the millions of medicine doses that Australians use and need every day.

The new agreements build on the Pharmaceutical Benefits Scheme (PBS) New Medicines Funding Guarantee, introduced in 2020, to safeguard the Government’s longstanding commitment to list on the PBS all medicines recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). The new agreements will further improve and safeguard access to new medicines through:

• equitable and sustainable access to the most effective medicines, including highly specialised, expensive and at times lifechanging medicines, through the PBS
• an Enhanced Consumer Engagement Process to facilitate enhanced consumer and patient engagement through the PBAC assessment process
• continuous improvement of health technology assessment processes for listing new medicines on the PBS to ensure they keep pace with the rapid advancement of health technology, remain world class, and keep pace with rapid advances in medicine enabling them to be marketed and funded in Australia as they emerge. 
• a new Medicines Supply Security Guarantee which will bolster medicine supply to Australian patients. The Medicines Supply Security Guarantee is designed to help protect Australian patients, pharmacists, and prescribers from the impact of the increasing number of global medicines shortages by implementing mandatory stock levels for certain critical high-volume medicines
• supporting the medicines industry who will benefit from stability and certainty for investment in new medicines, and providing certainty around health technology assessment processes
• supporting the work of pharmacists, prescribers and other healthcare workers by protecting the supply chain and reducing workloads and inconvenience created by medicines shortages
• commitments from the medicines industry to an improved statutory pricing system for PBS medicines which will generate net savings of approximately $1.9 billion, to be invested in new PBS medicines listings
• supporting the Australian medicines industry, including pharmaceutical manufacturers, wholesalers, compounders, hospital pharmacies, community pharmacies and consumers through continuous Government investment in new medicines.

The Strategic Agreements between Medicines Australia and the GBMA will be in place for five years from 1 July 2022 to 30 June 2027.

Key elements of the agreements:

• Funding for new medicines fact sheet (PDF 82KB) – (Word 21KB)
• Medicines Supply Security Guarantee fact sheet (PDF 90KB) – (Word 22KB)
• Health Technology Assessment review fact sheet (PDF 121KB) – (Word 24KB)
• Enhanced Consumer Engagement Framework fact sheet (PDF 103KB) – (Word 22KB)

Agreement documents

You may view copies of the Agreements at the following links:

• Medicines Australia Strategic Agreement - Signed (PDF 449KB) – (Word 131KB)
• Generic and Biosimilar Medicines Association Strategic Agreement - Signed (PDF 391KB) – (Word 97KB)