Awaiting committee decision: A turning point for the Critical Medicines Act

16 December 2025

Drawing on the expertise of the EPACT Alliance for the Digitalisation of Hospitals’ Medication Management Pathway in Europe, EHMA has proposed targeted amendments to address these gaps and support a more resilient, data-driven, and patient-centred approach to critical medicines management.

Council priorities: progress, but limited focus on clinical realities

Industrial resilience & vulnerability assessments – Strengthened supply-chain mapping, diversification, and vulnerability assessments. However, these measures remain upstream and do not improve hospital-level visibility of shortages.

Procurement resilience measures – Member States must apply resilience criteria (diversification, security of supply, stockholding). Yet procurement remains disconnected from real-time consumption and expiry data, limiting forecasting accuracy.

Governance reinforcement (CMCG) – Clearer mandate for the CMCG on information exchange and strategic project oversight. Without timely hospital data, coordinated allocation and shortage response remain limited.

Clarification of contingency stock rules – The Council adds transparency and proportionality requirements for stockholding obligations. Still, without systems to monitor expiry, burn rate, or redeployment, risking inefficiency and waste.

Strategic gaps: opportunities to strengthen resilience through digitalisation

The Council’s text leaves several structural gaps unaddressed – gaps that our amendments aim to close.

No national stock-visibility systems (N-CMSVS) – No requirement for interoperable IT systems collecting near real-time hospital stock and consumption data.
Supports Article 19a on establishing N-CMSVS linked to the ESMP.

No obligation for hospitals to provide structured data – Healthcare providers are not included in supply-chain reporting obligations.
→ Hospital data is essential to predict and mitigate shortages.

No measures on digitalisation or automation – No reference to automation, traceability, or digital stock monitoring.
Articles 19a and 20a offer the only operational route to clinical-level resilience.

No reference to waste, adherence or polypharmacy – Leftover medicines, adherence issues and environmental/AMR impacts are not addressed.
Articles 17, 18 and 30 link medication optimisation and waste reduction to supply security.

Procurement reforms disconnected from demand forecasting – Resilient procurement requires accurate, timely consumption and expiry data.
→ Reinforces need for hospital-generated data feeds through Article 19a.

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