GBMA puts medicine shortages on the table as strategic agreement talks begin

As the Generic and Biosimilar Medicines Association (GBMA) begins negotiations with government on the next strategic agreement, it has unveiled a new whitepaper calling for a fundamental shift in how Australia approaches medicine shortages.

The whitepaper, No Patient Left Waiting, was informed by the GBMA Summit, which brought together stakeholders to identify coordinated measures to strengthen market sustainability, detect emerging supply risks earlier and remove avoidable regulatory delays.

The call comes against a backdrop of Australia’s heavy reliance on international pharmaceutical supply chains.

More than 90% of prescription medicines used in Australia are imported, while the nation represents only around 2% of global pharmaceutical demand and 0.33% of the global population. Australia also sits in the bottom 25% of international medicine pricing, leaving it competing for supply in global markets where scale and commercial attractiveness influence manufacturing and distribution priorities.

GBMA Independent Chair Professor Jane Halton AO PSM said, “Australia has developed important mechanisms for managing medicine shortages once they occur. 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.”

The nation’s exposure to global medicines supply chains means external shocks, including sudden increases in freight, fuel, insurance, manufacturing or logistics costs, place additional pressure on already vulnerable supply arrangements. Such shocks do not necessarily create the underlying sustainability problem. Rather, they expose existing vulnerabilities within the market.

That vulnerability is particularly significant given the role of generic and biosimilar medicines in the healthcare system. They account for over 70% of medicines supplied through the Pharmaceutical Benefits Scheme (PBS), while representing less than 30% of the cost to taxpayers.

“Affordability, availability and resilience must be considered together. A medicine is only accessible if it remains available to the patient who needs it,” stated Professor Halton.

For patients living with chronic and complex conditions, however, reliable access to medicines extends well beyond questions of market efficiency or administrative process. Luke Escombe, an award-winning songwriter, musician and comedian, shared his experience of living with Crohn’s disease, illustrating the consequences that supply disruptions can have at an individual level.

“Patients cannot simply ‘wait’ when a medicine is unavailable. They may not have a substitute. They may not have time to navigate repeated appointments, pharmacy calls, special supply arrangements or emergency workarounds before their condition deteriorates,” reflected Escombe.

A shortage, delay or disruption is not merely a logistical problem. For patients, it can mean pain, relapse, deterioration, hospitalisation, loss of independence, loss of work and life-altering treatment decisions.

The pressures are already evident in medicines including duloxetine, candesartan and escitalopram, which have experienced supply disruptions as financial viability has declined, with the value of the molecules cut by around 80% between 2015 and 2025. This contributes to supply disruption, the withdrawal of brands from the PBS and potentially higher costs for patients.

While floor prices were introduced to prevent medicines from falling below a viable level, they have not been reviewed or indexed. As manufacturing, freight, active pharmaceutical ingredient (API), energy and stockholding costs rise, the real value of the floor price correspondingly falls.

Among the policy asks outlined by the GBMA are an adjustment of PBS floor-price settings, a review of minimum stockholding requirements (MSR) to target products with genuine supply vulnerability, and streamlined regulatory requirements including a more predictable Section 19A emergency-import pathway.

GBMA CEO Nikki Lorenz said, “This is not about choosing between affordable medicines and reliable supply. 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.”

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