Australians will have more affordable, improved and guaranteed access to medicines under landmark long-term Strategic Agreements between the Morrison Government and Australia’s medicines industry.
The new five-year Strategic Agreements between the Government and Medicines Australia and the Generic and Biosimilar Medicines Association (GBMA) continue the close partnership with the medicines industry, which is integral to Australians accessing innovative life-saving and life-changing medicines, vaccines and other novel therapies.
The COVID-19 global pandemic has cast a spot light on the importance of the Australian and global medicines supply chain and the Government has worked closely with the medicines industry over the past year to safeguard long term access to medicines for Australian patients.
The Government, Medicines Australia and the GBMA have developed a comprehensive package of improvements to the Pharmaceutical Benefits Scheme to ensure there is robust and uninterrupted supply of the medicines Australians need and use every day.
These improvements will also ensure that Australians can continue to gain access to new, and break-through medicines and treatments as early as possible.
These new five-year Strategic Agreements with Medicines Australia and the GBMA which commence in 2022 include the following key measures:
- An expected investment of approximately $5 billion in PBS medicines listings over the life of the agreement; through the PBS New Medicines Funding Guarantee and the reinvestment of efficiencies agreed with the sector.
- The co-design and implementation of an Enhanced Consumer Engagement Process to better capture the patient voice early in the medicines assessment process.
- Ongoing timely access to medicines through enhancements to Australia’s already world leading Health Technology Assessment (HTA) policy and methods.
- In an Australian first - a Medicines Supply Security Guarantee will be implemented – which includes an agreed commitment by medicines companies to hold additional onshore stock of critical medicines, of at least four to six months, to better protect patients against supply chain volatility.
- An improved statutory pricing system for medicines with efficiencies from price reductions agreed with the medicines industry to be reinvested in PBS medicines listings.
- A Horizon Scanning Forum to ensure Australians have early access to breakthrough treatments.
- Commitments to policy stability and predictability for the industry and Government.
These agreements will also foster partnerships with Australian researchers, and support investment in vaccines, new technologies, local clinical trials, research and development, manufacturing and Australian jobs.
Minister for Health and Aged Care, Greg Hunt, said these landmark agreements with the medicines industry will further strengthen Australia’s world-leading Pharmaceutical Benefits Scheme for patients and ensure improved stability, predictability and viability for the medicines industry.
“These agreements will also reduce the cost of prescription medicines and bolster the supply of medicines available through the PBS,” Minister Hunt said.
“They will also ensure that pharmacy shelves across Australia are continuously stocked with PBS medicines – and that Australians will have early access to new life changing medicines regardless of where they live.”
The COVID-19 pandemic has exacerbated shortages of many medicines including older and commonly prescribed medicines for diabetes, asthma, epilepsy, mental health conditions and antibiotics. The new Medicines Supply Security Guarantee means that manufacturers will be able to better manage supply chain risks for medicines that have been prone to shortage, which includes an agreed commitment by medicines companies to hold at least four to six months of stock of critical medicines in Australia.
The Medicines Supply Security Guarantee is designed to better protect Australian patients, pharmacists, and prescribers from the impact of the increasing number of medicines supply shortages and interruptions, both globally and domestically.
Consumers and patients will also have further opportunities to be more closely engaged in the Pharmaceutical Benefits Advisory Committee (PBAC) assessments for PBS medicines listings through the co-design and implementation of an Enhanced Consumer Engagement Process over the first year of the agreements.
These agreements will also oversee improvements to Australia’s world-class medicines assessment processes to ensure Australia keeps pace with the ever-changing advances in medicine and so that Australians can access the latest health technologies as soon as possible. The Health Technology Assessment Policy and Methods Review will cover methods for evaluating medicines for rare diseases, emerging technologies such as cell and gene therapies, and other precision-based medicines, the use of real-world evidence in decision making, and the feasibility of international work-sharing for reimbursement submissions, amongst other issues.
As part of the agreements, we will also introduce an improved statutory pricing system for PBS medicines that means efficiencies of approximately $1.9 billion over five years, which will be invested in PBS medicines listings. This builds on the PBS New Medicines Funding Guarantee, introduced in 2020 which ensures new funding is guaranteed each year for the listing of medicines on the PBS.
Together, the New Medicines Funding Guarantee and these efficiencies agreed with the industry will provide approximately $5 billion uncapped investment for new medicines over the life of the agreement, ensuring that patients can access break-through new treatments. These measures safeguard the Government’s longstanding commitment to list all medicines on the PBS that are recommended by the independent medical experts on the PBAC.
The dividend of these agreements are already benefiting Australian patients with recent new PBS medicines listings for cancer, severe eczema, migraine, diabetes, high cholesterol, schizophrenia and spinal muscular atrophy amongst others. In many cases these medicines would be out of reach for Australians and their families, but through the PBS they are available for $41.30 per script, or just $6.60 with a concession card.
Since 2013, the Coalition Government has approved more than 2,700 new or amended listings on the PBS. This represents an average of around 30 listings or amendments per month – or one each day – at an overall cost of around $13.6 billion.