Mapping National Incident Reporting Systems for High-Containment Laboratories Across Europe and Selected North American Jurisdictions
Julia Aniela BatorObjective:
To map incident reporting for high-containment laboratories across Europe and selected North American jurisdictions and assess whether reporting duties function as national reporting-and-learning systems.
Methods:
Comparative qualitative mapping using the purpose-built Framework for Assessing Incident Reporting Systems (FAIRS) assessed 31 jurisdictions: 27 European Union (EU) member states, Switzerland, the United Kingdom, the United States, and Canada, plus the EU as a supranational layer. FAIRS assessed six maturity dimensions: (1) legal authority, (2) governance, (3) reporting scope, (4) reporting pathway/data infrastructure, (5) analysis/shared learning, and (6) assurance/continuous improvement. Each was scored from maturity level (ML)1 (ad hoc or weakly specified arrangements) to ML4 (mature systems with demonstrable learning, review, and improvement). Data came from official legal and institutional sources collected January–May 2026, supplemented by targeted expert consultation.
Results:
Legal authority was common but learning functions were much weaker. Mean scores were highest for legal authority (3.0) and assurance (2.5), and lowest for reporting pathway/data infrastructure (1.9) and analysis/shared learning (1.5). All but one entity scored ML3 on legal authority; only two scored above ML2 on data infrastructure, and Canada alone reached ML4 on analysis/shared learning. Three system types emerged: one visible operational exemplar (Canada), 11 coordinated partial systems, and 20 regulated but weakly operationalized systems. The EU layer contributed legal duties without an EU-level reporting-and-learning chain.
Conclusion:
Formal duties are more widespread than functioning national learning systems; the main governance divide is whether reports are aggregated, analyzed, and translated into feedback and system improvement.