This website uses cookies to improve your experience. You can accept or reject analytics cookies
Plan Estatal De Preparación Y Respuesta Frente A Amenazas Graves Para La Salud
Pandemic Preparedness and ResponseLaw2025
SpainSpanishPDF
National
AI-Generated Document Summary
Objectives
Establish a State Plan for Preparedness and Response to Serious Health Threats to prevent, detect, assess and manage public-health emergencies, epidemics, pandemics and other crises, reducing their health, social and economic consequences through a coordinated national framework.
Strengthen surveillance, early warning, risk assessment, preparedness and response capacities in alignment with the International Health Regulations (2005), Regulation (EU) 2022/2371 and relevant national, European Union and international planning frameworks.
Apply the Plan to biological threats, including communicable diseases, antimicrobial resistance and healthcare-associated infections, as well as chemical, environmental, climate-related, nuclear, radiological and unknown-origin threats.
Embed equity, non-discrimination, universal accessibility, territorial cohesion, Health in All Policies and One Health, with particular attention to vulnerable populations and the social determinants of health.
Promote multisectoral, multilevel and interdisciplinary action, including behavioural and social sciences, cooperation between healthcare and public-health services, and coordination with civil protection and national security arrangements.
Ensure proportionate, scientifically grounded and time-limited crisis measures that protect continuity of healthcare, access to medicines and health products, and the functioning of other sectors.
Improve public communication by providing clear, reliable and locally adaptable information for the public and National Health System professionals, including content accessible to vulnerable groups and measures to counter misinformation.
Develop national, autonomous-community and city-level preparedness and response plans that are coherent and interoperable, while allowing national intervention or coordination when a threat exceeds local or regional capacity.
Build and maintain essential preparedness capacities, including strategic medical reserves, healthcare-capacity information, specialised isolation and treatment units, laboratory surge capacity, trained personnel, rapid-response teams and capabilities at points of entry.
Implementation
Implement the Plan through coordinated governance led by the Ministry of Health, combining State-level intersectoral coordination with National Health System mechanisms, autonomous plans, rapid alerting and assessment procedures, operational capacities, public communication, evaluation and periodic improvement.
Establish the State Coordination Commission, known as CECO, as the collegiate mechanism for General State Administration participation, cross-sector information exchange, resource assessment and national preparedness and response coordination.
Coordinate healthcare, public-health and communication actions through the Interterritorial Council of the National Health System, its Public Health Commission, technical groups, committees and working groups, alongside the Ministry of Health, autonomous communities, and the cities of Ceuta and Melilla.
Require autonomous communities and the cities of Ceuta and Melilla to prepare plans aligned with the State Plan, covering governance, risk-based capacities, strategic reserves, psychosocial support, resources, threat mapping, surveillance and reporting; plans must be prepared within one year and substantial amendments notified within two months.
Operate the Early Warning and Rapid Response System within the State Public Health Surveillance Network to detect, notify and assess events; notify potential national or international risks urgently and, where applicable, within 24 hours of identification.
Apply transparent risk assessment based on excellence, independence and impartiality, drawing on networks of institutions, agencies, scientific societies, experts and relevant public and private organisations.
Convene an independent multidisciplinary advisory group for serious events, with its first joint meeting with the technical committee of the Early Warning and Rapid Response System within 24 hours after the group is constituted.
Enable the Minister for Health to declare a Public Health Emergency of National Importance, supported by a technical report, advisory input and coordinated consideration through National Health System structures; review a declared emergency at least every three months.
Maintain a national strategic reserve of medicines, medical devices and other essential materials; coordinate procurement, storage, supply and distribution with regional reserves; and support investment in research, development, manufacture and security of supply for medical countermeasures.
Develop a digital platform for real-time healthcare-capacity information, a network of High-Level Isolation and Treatment Units, national reference laboratory arrangements, secure sample transfer, laboratory surge planning and rapid-response public-health teams coordinated by the State Public Health Agency.
Deliver measures at points of entry through External Health Services and Ministry of Health coordination, in collaboration with competent autonomous-community and city authorities where appropriate.
Use drills, training and multisectoral exercises to test implementation; develop indicators within one year of entry into force; and publish a public preparedness-planning and capacity report every three years through the State Public Health Agency.
Use existing State and autonomous-community organisational structures for core implementation during the first two years, while recognising that strategic reserves, laboratory capacity and rapid-response teams require additional expenditure and staffing; no quantified budget or financing allocation is specified.
Process personal data under Royal Decree 568/2024, the General Data Protection Regulation and Organic Law 3/2018 on personal data protection and digital rights.
Monitoring & Evaluation
The framework establishes an integrated surveillance, alerting, risk-assessment, reporting and review system for serious health threats. It combines the Early Warning and Rapid Response System with structured risk assessment, periodic preparedness reviews, public reporting and corrective action, coordinated through national health-system bodies.
Detect, notify and assess events, risks, syndromes, diseases and other situations that may endanger population health through the Early Warning and Rapid Response System.
Notify potential national or international public-health risks urgently, within 24 hours of identification where applicable.
Apply transparent risk assessments founded on excellence, independence and impartiality, drawing on information from public authorities, relevant organisations, scientific bodies and expert networks.
Publish risk assessments after informing participating organisations, unless urgency and necessity require immediate publication.
Review a declared Public Health Emergency of National Importance at least every three months, with the technical committee and advisory group reporting to the Minister for Health before the Interterritorial Council of the National Health System considers extension or termination.
Evaluate annually whether High-Level Isolation and Treatment Units continue to meet network membership requirements.
Assess and report periodically on the preparedness and response capacities of the State Plan and autonomous-community and city plans, including threat mapping, risk detection and resource availability.
Develop indicators within one year of the decree entering into force to monitor, update and continuously improve the State Plan and autonomous plans, subject to approval by the Public Health Commission.
Publish a State Public Health Agency report every three years on preparedness planning, governance, capacities, resources and actions to address deficiencies identified through earlier evaluations; submit it to the Public Health Commission, the Interterritorial Council and the State Coordination Commission, and make it public.
Test implementation through multisectoral drills and training exercises, and develop action plans based on evaluation findings.
Use climate-change health indicators to inform adaptation and mitigation decisions and continuously evaluate the impact of measures.
Collect disaggregated information on health equity and sex where applicable through the surveillance network to assess impacts and their interaction with other determinants.
Accountability is principally exercised through the Ministry of Health, the State Coordination Commission, the Public Health Commission and the Interterritorial Council of the National Health System. Autonomous communities and the cities of Ceuta and Melilla must share their plans and notify substantial amendments to the Ministry of Health through the Public Health Commission within two months of approval.
Although the framework provides for indicators, periodic reports, emergency reviews, plan evaluations and exercises, it does not specify a complete quantitative indicator set, reporting templates, performance targets, detailed evaluation methodology or independent accountability mechanism in the supplied text.
Costing & Financing
The framework recognises that preparedness requires sustained resources for strategic reserves, medical countermeasures, laboratories, specialised treatment units, digital capacity platforms, trained personnel and rapid-response teams. Most supplied provisions do not provide quantified costs or financing sources, but the impact assessment distinguishes initially cost-neutral organisational measures from capacity-building measures requiring additional expenditure.
Implement organisational structures, coordination mechanisms, autonomous plans, early warning, emergency declarations and preparedness reporting during the first two years using existing General State Administration and autonomous-community structures and resources, with reallocations not affecting personnel allocations.
Increase expenditure across several budget lines, including staffing, to establish preparedness and response capacities, particularly the national strategic reserve, laboratory capacity and rapid public-health response teams.
Link this additional expenditure partly to recently approved legislation and existing extended State budgets for the Ministry of Health, the National Institute of Health Management and the Spanish Agency for International Development Cooperation, among others.
Agree a specific medium- and long-term budget for the national strategic reserve once its configuration and management responsibilities between autonomous communities and the General State Administration have been determined.
Support public investment across the lifecycle of medical countermeasures, including research, development, manufacture, production, procurement, storage, supply and distribution, to reduce shortages and protect security of supply.
Assess national resource needs and availability and propose mechanisms to make resources available to competent authorities throughout the country.
Operate committees and meeting participation without remuneration.
No quantified overall budget, expenditure ceiling, unit cost, funding gap, dedicated financing instrument or resource-mobilisation amount is specified. The document identifies positive expected economic effects from reducing the likelihood, duration and consequences of health crises, but does not provide a quantified economic estimate.
The proposal is not expected to affect product or service prices beyond normal market operation or to generate costs relating to the European Union or other economies. It creates no administrative charges or fees for the public or private sector, although public procurement may create opportunities for private providers.