Australia must move beyond managing medicine shortages after they become visible and strengthen the domestic settings that can help prevent more shortages from reaching patients, according to a new white paper released by the Generic and Biosimilar Medicines Association (GBMA).
No Patient Left Waiting: A Reform Roadmap for Medicine Supply Resilience calls for coordinated action to strengthen medicine-market sustainability, identify emerging supply risks earlier and remove avoidable regulatory delays.
The white paper was informed by GBMA’s inaugural Medicines Supply Resilience Summit and subsequent discussions with patient, clinical, pharmacy, and medicines-industry stakeholders.
GBMA Independent Chair, Hon. Prof. Jane Halton AO PSM said Australia could not control every global manufacturing or supply-chain disruption, but it could ensure its domestic policy settings helped the country withstand them.
“Australia has developed important mechanisms for managing medicine shortages once they occur,” Hon. Prof. Halton said.
“The next stage of reform must focus on prevention: addressing the market, pricing, stockholding and regulatory settings that can make Australia more vulnerable, before a shortage reaches patients.
“Affordability, availability and resilience must be considered together. A medicine is only accessible if it remains available to the patient who needs it.”
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 per cent of medicines supplied through the PBS, while representing less than 30 per cent of the cost to taxpayers. The resilience of this sector is therefore central to the resilience and affordability 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 identification, 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
GBMA CEO, Nikki Lorenz said the proposed reforms were intended to build on the significant work already undertaken by government, the TGA and healthcare stakeholders.
“This is not about choosing between affordable medicines and reliable supply, she said.
It is about creating settings that deliver both, and reducing the patient, workforce and system costs that arise when action occurs only after a shortage is already affecting care.”
The white paper identifies benefits across the health system, including fewer disruptions and clearer information for patients, less time spent sourcing alternatives by healthcare professionals, lower emergency-response costs for government and more predictable supply settings for industry.
No Patient Left Waiting: A Reform Roadmap for Medicine Supply Resilience is available for download here
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About GBMA
The Generic and Biosimilar Medicines Association (GBMA) is the peak representative body of generic and biosimilar medicine suppliers in Australia. Its members ensure that all Australians are offered the highest quality generic and biosimilar medicines in the world whilst providing affordable community health outcomes that benefit all Australians.
