Europe’s antibiotic supply chain stands at a critical juncture. Years of declining medicine prices, combined with rising production and energy costs, have undermined the economic sustainability of many off-patent antibiotics. A new wave of European policy analysis warns that without structural reform, essential medicines such as amoxicillin, cefalexin, and ciprofloxacin will remain at constant risk of shortage.
The report, sponsored by Viatris and titled Securing Access, Improving Lives, argues that the often vital, always undervalued antibiotics have been trapped in a policy paradox. Price controls and budget containment have achieved short-term savings for health systems but, in the process, weakened the long-term viability of manufacturers. Between 2020 and 2024, prices for the most widely used off-patent antibiotics fell by more than 10 percent, while production costs surged by over 30 percent. That imbalance has driven market withdrawals and an over-reliance on a shrinking pool of suppliers.
The report calls for a “viable economics for manufacturers” of off-patent medicines to ensure reliable and stable supply. This approach would acknowledge that older antibiotics still require sufficient margins to justify ongoing production and compliance with regulatory standards. Policy makers are urged to move beyond the fixation on the lowest possible price and to safeguard a diverse supplier base through measures that value resilience and continuity.
Competition remains important, but the analysis stresses that market health depends on diversity rather than a race to the bottom. At least two or three qualified suppliers per molecule are recommended to prevent monopolistic fragility. Preserving this level of redundancy would allow national health systems to respond more effectively to demand fluctuations or manufacturing disruptions.
Balancing stewardship and sustainability
Another recurring theme is the need to align financial incentives with antimicrobial stewardship. While efforts to curb unnecessary antibiotic use remain central to fighting resistance, stewardship policies must not undermine the commercial foundations needed to keep essential drugs available. This balance requires nuanced pricing mechanisms that encourage responsible use without discouraging manufacturers from remaining in the market.
The report outlines a set of interlinked policy goals:
Guarantee stable revenues for critical medicines.
Prioritize sustainability of health budgets alongside patient access.
Encourage partnerships among governments, payers, and manufacturers to share data and risk.
Integrate procurement and pricing policies under a coherent European framework.
Among the practical recommendations are several pricing interventions. One is automatic indexation – linking antibiotic prices to objective cost indicators such as inflation, energy prices, and industrial producer indices. This would prevent sudden erosion of margins during economic shocks.
Another proposed mechanism is volume-delinked reimbursement. Instead of paying per unit sold, governments would provide predictable annual revenue guarantees for low-volume, high-importance medicines. Sweden’s pilot revenue guarantee model, cited in the report, demonstrates how such a scheme can stabilize supply for critical antibiotics while supporting stewardship objectives.
Tiered pricing linked to market structure could further differentiate reimbursement levels between high- and low-volume products. Meanwhile, the report recommends easing or eliminating payback and clawback measures that currently penalize older medicines with limited profitability.
Reducing administrative and environmental burdens
Beyond pricing, the authors highlight regulatory and environmental pressures that add to the financial strain. Manufacturers face complex approval processes, frequent price revisions, and costly compliance with new environmental standards. The report suggests more flexible timelines for meeting sustainability requirements and greater coordination between health and environmental agencies to avoid disproportionate costs on low-margin drugs.
Procurement reform is described as essential to reversing Europe’s antibiotic fragility. The report urges countries to move away from the “single-winner tender” model, which awards contracts solely on price and discourages supplier diversity. Instead, the authors add, tenders should allow multiple winners and evaluate bids using the Most Economically Advantageous Tender (MEAT) framework, which incorporates quality, reliability, and security-of-supply criteria alongside cost.
The report concludes with an emphasis on the fragility of off-patent antibiotic markets – not as a temporary disruption, but a structural failure. Ensuring sustainable access will require coordinated action at both national and EU levels. Mechanisms such as the new Critical Medicines Act, the European Medicines Agency’s Coordination Mandate, and the formation of a Critical Medicines Alliance are key to aligning procurement, pricing, and market-stabilization strategies across borders.
By adopting forward-looking, evidence-based policies that reward reliability and quality of supply, Europe can protect its essential antibiotic supply. Sustaining access to antibiotics, the report concludes, demands a recalibration of Europe’s entire pharmaceutical policy framework.
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