Strengthening Medicine Shortages Management for Enhanced Availability and Access

The European Medicines Agency made medicine shortages management a foundational policy objective in 2025, as highlighted in its annual reports and work programmes. By advancing coordinated shortages oversight and deeper integration with health technology assessment processes, the agency delivered measurable improvements in proactive supply management and regulatory-HTA alignment that accelerate patient access without compromising scientific standards.

Enhanced collaboration across the European medicines regulatory network enabled rapid deployment of new tools while embedding HTA considerations earlier in medicine development. The resulting framework reflects a deliberate shift toward system-level preparedness that tackles both immediate disruptions and structural barriers to timely therapeutic availability.

Digital Platforms Powering Anticipatory Action

The methodological foundation rests on the European Shortages Monitoring Platform, a centralized digital system that aggregates real-time supply and demand data from national competent authorities and marketing authorization holders. This infrastructure strengthens the Medicine Shortages Steering Group and SPOC Working Party, enabling systematic identification of vulnerabilities and swift activation of the Voluntary Solidarity Mechanism during critical shortages.

Parallel Joint Scientific Consultations introduced under the HTA Regulation in January 2025 created structured channels for regulators and HTA bodies to align on evidence plans from the earliest development stages. Information-exchange protocols and joint review milestones reduced duplication while respecting each body’s distinct responsibilities.

These tools convert reactive shortage handling into anticipatory governance backed by standardized data flows and shared scientific advice. Regulatory assessments and HTA evaluations now draw from a common evidence base, increasing predictability for developers and health systems.

Critical List Growth Delivers Supply Chain Gains

The Union List of Critical Medicines grew to approximately 300 active substances in 2025, directing targeted recommendations that strengthen weak points in radiopharmaceuticals and anti-D immunoglobulins. Repeated activations of the Voluntary Solidarity Mechanism proved the network’s ability to redistribute stocks efficiently during acute shortages.

This progress in medicine shortages management coincided with full implementation of the Clinical Trials Information System, streamlined assessment pathways, greater use of the PRIority Medicines scheme, accelerated assessments, and conditional marketing authorisations. The political agreement on revised EU pharmaceutical legislation further signalled upcoming regulatory simplifications.

Initial parallel Joint Scientific Consultations demonstrated practical alignment of evidence requirements between regulators and HTA bodies. Together these efforts produced a clear shift toward earlier, more coordinated availability of both established and innovative therapies across member states.

HEOR Expansion in a Resilient EU Ecosystem

The closer integration of regulatory and HTA pathways signals that health economics and outcomes research will play a larger upstream role through joint scientific advice. Early alignment on clinical and economic data needs can minimise later uncertainties that complicate reimbursement decisions.

Medicine shortages management strengthened by centralised monitoring and solidarity protocols gives health systems greater supply predictability. Payers can now incorporate resilience metrics into value assessments and procurement strategies, prompting HEOR analyses to broaden beyond traditional clinical benefit and cost-effectiveness measures.

The EMA’s operational support for the HTA Regulation promises more efficient use of network resources and faster translation of innovation into patient access. Market access professionals should therefore design development programmes that satisfy both regulatory and HTA expectations from day one, supporting sustainable pricing and reimbursement within Europe’s evolving pharmaceutical framework.