EU Council Regulation 2022/2372 — HERA emergency framework for crisis medical countermeasures

Mechanism

Council Regulation (EU) 2022/2372 creates a two-stage crisis architecture for medical countermeasures (MCMs). In normal times HERA operates under its founding Decision (EU) 2021/2121. When a public health emergency at Union level is declared under Regulation (EU) 2022/2371 (Serious Cross-Border Health Threats), 2022/2372 activates HERA's emergency-mode powers:

1. Joint procurement — HERA may conclude framework contracts for MCMs on behalf of all Member States that sign a joint-procurement agreement, bypassing standard Directive 2014/24/EU procurement timelines. 2. Demand-information requests — Marketing-authorisation holders (MAHs) and major manufacturers are subject to mandatory disclosure of production capacities, stockpile levels, and supply-chain bottlenecks; failure to comply is subject to fines up to 0.15% of total turnover. 3. Emergency Research and Innovation Plan — HERA may redirect existing Horizon Europe and EU4Health allocations to accelerated MCM R&D without a new budgetary decision. 4. Stockpile authority — HERA coordinates Union-level strategic reserves of priority MCMs, building on lessons from rescEU medical stockpile and the COVID ACT-Accelerator experience.

The regulation explicitly defines "crisis-relevant medical countermeasures" to cover: (a) vaccines; (b) therapeutics and antidotes; (c) medical devices including in-vitro diagnostics; (d) PPE; and (e) other products or substances necessary to prevent or treat the threat. This broad scope means any major cross-border pharmaceutical or medtech manufacturer with EU operations is a potential subject of mandatory-information or joint-procurement mechanisms during an emergency.

Relationship to the HERA ecosystem

Regulation 2022/2372 is the emergency-mode counterpart to HERA's standing Decision (EU) 2021/2121 (which governs preparedness activities in peacetime). The two instruments together form the full HERA legal basis. A declaration under Regulation (EU) 2022/2371 is the prerequisite trigger — 2022/2371 was itself updated by a 2022 package alongside this regulation.

Structural successors extend the 2022/2372 architecture beyond emergencies:

• 2025-03-11-eu-critical-medicines-act-proposal — COM(2025) 102, extends joint-procurement and

supply-security tools to steady-state critical medicines (outside declared emergencies); HERA designated as the operational hub.

• 2025-12-11-eu-pharma-package-trilogue-agreement — parallel pharmaceutical-regulatory reform

restructuring marketing-authorisation incentives; 2022/2372 HERA mandate shapes the supply-security chapter of the Pharma Package.

Severity rationale

Severity 3 (moderate). The regulation is foundational and legally binding but its direct market interventions are conditional on a formal public health emergency declaration at Union level — a high activation threshold. In non-emergency periods operators face no operational obligations under this instrument. The mandatory-information obligations during emergencies create compliance exposure for large MAHs but financial penalties are capped at 0.15% of turnover. The joint-procurement mechanism displaces commercial contracting channels during crises and can set effective price floors/ ceilings but does not alter baseline market structure.

Open questions

• Exact activation thresholds in Regulation (EU) 2022/2371 (which health threats qualify for a

Union-level public health emergency declaration vs. a "serious cross-border health threat" designation).

• Whether the fines cap (0.15% turnover) applies to each non-compliance episode or aggregates across

the emergency period.

• Implementation status of the Emergency Research and Innovation Plan mechanism — no activation since

the regulation came into force.

• Whether the 2025 MCM Strategy (COM(2025) 529) will propose amendments to the 2022/2372 threshold

architecture to allow HERA to act on pre-emergency "early warning" signals.