Medicine shortages don’t arrive with a siren. They arrive at a pharmacy counter – quietly, yet acutely felt.
A patient with epilepsy is told their usual brand isn’t available. A parent is sent home without the ADHD medicine their child needs today, not next week. A cancer patient’s regimen is changed not because it’s clinically better, but because it’s what can be sourced. Behind the scenes, pharmacists lose hours calling wholesalers, checking alternatives, managing worried families, and then doing it all again tomorrow.
For years, this disruption was dismissed as “seasonal,” “Brexit-related,” or simply the reality of global supply chains. Some felt Ireland could ride out the turbulence. Yet even then, the regulator’s own lists showed the scale of the problem.
Growing evidence made the problem harder to dismiss. The Medicine Shortages Index, first published at the end of 2022, addressed a central issue: shortages were being treated as anecdote rather than quantified risk. By drawing on publicly available data, it tracked trends and exposed underlying vulnerabilities, most notably the dependence on single-source medicines, where one supplier failure can quickly become a national clinical issue.
A White Paper followed, setting out practical, system-focused solutions grounded in the realities of a small market. These included an essential medicines list, stronger supplier resilience, faster regulatory pathways and the use of pricing tools to sustain supply.
That work helped shift the debate from “shortages happen” to “shortages can be managed – if we choose to manage them.”
Now we have a new test of that choice: the 2026–2029 Framework Agreement on the Supply and Pricing of Medicines (FASPM). It is the clearest recognition yet, in a national State–industry agreement, that security of supply must be engineered, not hoped for.
It acknowledges that supply security requires active management. But it is cautious in how far it goes. And just weeks into its life, that caution is already being tested.
A combination of higher tariffs and conflict in the Middle East has disrupted global markets. For medicines, the implications are immediate. While Ireland manufactures high-value medicines, the supply of many generic medicines and their ingredients remain heavily dependent on Asia. They move from east to west at scale, through complex air, land and sea supply chains. When those routes are disrupted, costs rise quickly and availability becomes less certain.
Energy prices have surged, freight routes have been destabilised, and the cost of key pharmaceutical inputs is rising sharply. In some cases, active pharmaceutical ingredient costs are already up by as much as 60 per cent. By year end, those pressures are likely to be felt more acutely in smaller markets such as Ireland, where pricing flexibility is limited.
Countries such as the UK are already warning of potential shortages. Ireland, as a smaller and more price-sensitive market, will not be insulated. The economic assumptions underpinning the Agreement have been undercut almost immediately. In that context, the modest uplifts and targeted pricing mechanisms are being quickly overtaken by events.
The Agreement introduces measures that begin to address structural risks. But their scale sits uneasily against the pressures now emerging.
The provision for urgent pricing uplifts is a pragmatic intervention, recognising that low prices can deter supply. However, its narrow scope and protracted decision-making process mean it is likely to apply to relatively few products and will struggle to offset rising costs in time to prevent shortages.
The value maintenance realignment clause reflects an acknowledgement that sustainability matters. However, an increase of just 1.5 per cent annually means it is already being outpaced by rising tariffs, geopolitical disruption and overall inflation. Restricting its application to a defined list of just 39 medicines also limits its ability to anticipate and mitigate future shortages.
Efforts to reduce reliance on exempt medicinal products are directionally correct, but the pathway to transition remains unclear. Without stronger incentives, the system risks continuing to rely on these expensive, unlicensed workarounds.
Provisions on shortage notification provide better visibility, including longer notice periods. But visibility is not resilience. The absence of stronger preventative measures, such as stockholding requirements or coordinated supply planning, remains a gap.
Price increase pathways introduce needed flexibility. Yet decision timelines of 60 to 90 days are out of step with disruptions that, as we are seeing, can unfold in hours.
Recent events have reinforced a central reality: medicine supply chains are not just fragile, they are highly exposed to geopolitical and economic shocks.
Where pricing remains constrained and response mechanisms are slow, supply will continue to favour larger, more commercially attractive markets. In that sense, the risks that have driven shortages in recent years have not disappeared. In truth, they are magnifying.
The Agreement may ultimately be judged less on what it introduces, and more on how it performs under pressure. Our immediate priority must be implementation and proactiveness. However, the system’s tendency to respond to events rather than anticipate them remains a concern.
If the mechanisms within the Agreement are applied effectively, they may help mitigate some pressures. But the scale of external shocks suggests that further adaptation will be required.
There is a clear case for going further – expanding the scope of essential medicines, introducing more responsive pricing mechanisms, and embedding a more proactive approach to supply resilience.
For too long, medicine shortages were treated as isolated incidents rather than systemic risks. The new Agreement represents a serious attempt to address them. But it has arrived into a world that is already changing.
Minister Jennifer Carroll MacNeill deserves credit for advancing a framework that begins to engage with these issues. But frameworks are only as strong as their ability to withstand real-world pressures, and those pressures are already intensifying.
By Sandra Gannon, Managing Director, Azure Pharmaceuticals
Read the original Irish Times article here