No Patient Left Waiting: A Reform Roadmap for Medicine Supply Resilience.
Australia has invested significantly in mechanisms that help manage medicine shortages once they are visible.
The next challenge is to prevent more avoidable shortages from reaching patients and to coordinate more effectively when global disruption cannot be avoided
No Patient Left Waiting: A Reform Roadmap for Medicine Supply Resilience sets out practical reform to help government, healthcare professionals, patients and industry work together to support better medicine access.
The White Paper was informed by GBMA’s inaugural Medicines Supply Resilience Summit and subsequent discussions with patient, clinical, pharmacy, policy, supply-chain and medicines-industry stakeholders.
Why reform is needed
More than 90 per cent of prescription medicines used in Australia are imported, exposing the country to global manufacturing disruptions, logistics pressures and competition for limited supply.
Generic and biosimilar medicines account for more than 70 percent of medicines supplied through the PBS, while representing less than 30 percent of the cost to taxpayers. Maintaining the strength of this sector is therefore central to the sustainability of Australia’s medicines system.
The White Paper seeks three linked commitments.
Strengthen long-term PBS sustainability settings
The paper recommends reviewing PBS floor-price settings, introducing targeted indexation for vulnerable low-cost medicines and ensuring Minimum Stockholding Requirements are risk-based, evidence-led and proportionate.
Improve shortage management, coordination and communication
It proposes to co-design with Government and the TGA a targeted shortage management partnership that enables earlier coordinated action before shortages affect patients, building on existing mechanisms and using peak bodies as a neutral coordination point where appropriate.
The paper also recommends updating the TGA Medicine Shortages Database, so shortages are grouped by molecule or active ingredient, supported by audience-specific information and practical guidance on alternatives, where clinically appropriate.
Streamline regulation without lowering standards
The white paper calls for greater use of reliance and recognition pathways, faster processing of supply critical variations and a more predictable and proportionate section 19A emergency-import pathway.