Piano Strategico-Operativo Nazionale Di Preparazione E Risposta A Una Pandemia Influenzale (PanFlu) 2021-2023

Objectives

Italy’s 2021–2023 National Strategic Operational Plan provides a national framework and decision-making guide for preparedness, response and recovery across inter-pandemic, alert, pandemic and transition phases. Its overarching purpose is to protect individual and collective health, minimise cases and deaths, protect health workers and emergency personnel, preserve essential health and social services, reduce societal and economic disruption, and restore normal activities while preparing for subsequent waves.[1][2][3]

The Plan applies a risk-based, sustainable and resilient preparedness model for influenza while recognising that the capabilities developed should be adaptable to novel respiratory pathogens with pandemic potential. It draws on World Health Organization guidance, International Health Regulations core capacities, European technical guidance, lessons from the 2009 influenza pandemic and COVID-19, and relevant national legal arrangements.[4][1][5]

• Strengthen governance, multisectoral coordination and clearly defined national, regional and local roles for pandemic preparedness and response.[6][7]
• Maintain and enhance epidemiological, virological, event-based and One Health surveillance to detect emerging, zoonotic and pandemic influenza threats promptly.[6][8][9]
• Develop national and regional contingency arrangements, scalable healthcare capacity and continuity plans for essential services.[10][11][12]
• Protect patients, health workers and communities through infection prevention and control, personal protective equipment, clinical guidance and ethically grounded allocation of scarce resources.[13][14][15]
• Implement vaccination, antiviral, non-pharmaceutical intervention and strategic stockpiling measures to reduce transmission, morbidity and mortality.[16][17][18][19]
• Strengthen training, exercises, risk communication, community engagement, research, diagnostics and laboratory capacity.[20][21][22][23]
• Support recovery through de-escalation criteria, restoration of essential services, epidemic-risk monitoring and post-pandemic learning.[3][24]

The Plan requires regional adaptation to territorial needs, including targeted arrangements for major transport routes, ports and airports, while retaining nationally coherent preparedness standards. Regional and Autonomous Province plans must be approved within six months of national-plan approval and implementation must begin within the following 120 days.[25][26]

Its strategic outlook acknowledges uncertainty in the timing, severity and epidemiology of future pandemics. Planning therefore uses differentiated scenarios, including more transmissible or severe events, and requires flexible capacity that can be scaled according to epidemic risk, health-service pressure and country-specific vulnerability.[27][28][29]

Implementation

Implementation is organised as a continuous preparedness cycle combining national direction, regional delivery, local operational planning, surveillance, exercises, evaluation and revision. The Ministry of Health coordinates the National Health Service response and leads the Italian influenza pandemic preparedness network, which includes representatives of Regions and Autonomous Provinces and relevant national public-health, medicines, health-service and research institutions.[6][30][31]

• Establish a national contingency plan with defined functions and responsibilities, coordinated with the Department of Civil Protection and involving health-system and emergency actors, including general practitioners, paediatricians, pharmacists, nurses, civil protection, armed forces and security services.[10][32]
• Operate the DISPATCH multidisciplinary expert network to assess pandemic scenarios, quantify possible effects on the Italian population and health services, and inform contingency-plan updates.[6][33][34]
• Use InfluNet, the National Influenza Centre, the Italian Epidemic Intelligence Network, event-based surveillance and rapid-alert mechanisms to detect, assess and communicate unusual events and influenza threats.[35][8][36]
• Develop the national Rapid Alert and Response System with secure information exchange between central and regional National Health Service actors.[9]
• Require regional plans to define responsibility chains, coordination arrangements, service-capacity measures, infection-control arrangements, staff training, stockpiling criteria and communication channels.[25]
• Scale territorial, hospital and intensive-care capacity through care-network mapping, alternative facilities, home care, telemedicine, workforce redeployment, emergency transfers and coordination with private providers and volunteers.[37][38][39]
• Maintain strategic stocks and procurement mechanisms for personal protective equipment, medicines, vaccines, medical devices and laboratory supplies, including storage capacity for the first three months of a pandemic.[40][19][20]
• Deliver cascade training, annually updated distance-learning modules and simulation exercises every two years to build skills, test procedures and improve interoperability.[41][42][43][44]
• Activate coordinated risk communication structures, authorised information procedures and community-engagement mechanisms, including measures to counter misinformation, stigma and discrimination.[22][45][46]

During alert and pandemic phases, the model allows escalation or de-escalation according to virological, epidemiological and clinical evidence, national risk and severity assessments, geographic spread, service pressure and resilience. The World Health Organization communicates international pandemic-phase changes, while national authorities communicate the domestic alert level and, where applicable, pandemic declaration.[47][48][49]

Monitoring follows a three-year cycle. Formal implementation monitoring begins in the first year using responsible actors, documentary evidence and specified timescales in operational tables; a functional and operational simulation exercise in the second year tests alert- and pandemic-phase arrangements; and findings inform plan revision, approval and dissemination.[2][50][51]Annual checks use questionnaires and the Appendix A4 self-assessment checklist, while an external evaluation system is coordinated by the Ministry of Health with Regions, Autonomous Provinces and the Istituto Superiore di Sanità.[52][53]

Regions and Autonomous Provinces must report implementation progress within 12 months, and a working group monitors planning implementation across territories.[25][54]The Plan also provides for In-Action Reviews and After-Action Reviews during or after emergencies to identify lessons and update pandemic and contingency plans.[3][24]

Regional plans must estimate the economic resources required for implementation. These resources are intended to be financed through pandemic-specific funds additional to National Health Fund and Regional Health Fund allocations; annual resource estimation and allocation for inter-pandemic activities was envisaged from 30 April 2021.[25][31]The Plan does not specify monetary budget values, fund sizes or detailed allocations.[25][31]

Monitoring & Evaluation

The plan establishes a three-year monitoring, evaluation and updating cycle for 2021–2023, combining formal implementation monitoring, functional assessment, simulation exercises, revision and post-pandemic learning.[2][55][51][52]

• Monitor implementation from the first year through action tables that identify responsible actors, documentary evidence of completion and implementation timescales; conduct annual checks using questionnaires and the Appendix A4 self-assessment checklist.[2][51][52][53]
• Conduct a functional and operational assessment in the second year, particularly for alert- and pandemic-phase actions, through a simulation exercise involving regional representatives and relevant national actors.[2][50][51][56]
• Revise the plan using simulation findings, thematic assessments and current international recommendations, with updating envisaged by the end of 2023.[50][51][56]
• Use an external evaluation system coordinated by the Ministry of Health, working with competent directorates and the Italian influenza pandemic preparedness network.[53]

Surveillance is a core monitoring function across all phases. Routine inter-pandemic surveillance covers influenza-like illness and virological influenza activity; surveillance and continuous risk assessment intensify during the alert phase and inform movement between phases using virological, epidemiological and clinical evidence, case trends, incidence and pressure on health services.[57][47][58]

• Maintain InfluNet as the integrated epidemiological and virological influenza surveillance system, coordinated by the National Institute of Health, to monitor seasonal influenza, circulating viruses, unusual activity and changing pandemic conditions.[35][59]
• Provide periodic surveillance reports to the Ministry of Health and Regions and Autonomous Provinces, including weekly InfluNet bulletins during the influenza season.[60]
• Integrate indicator-based, event-based, syndromic, human, animal and wildlife surveillance through a One Health approach, including the Italian Epidemic Intelligence Network and the proposed national Rapid Alert and Response System.[8][9][36][61]
• Exchange alerts and relevant information through World Health Organization focal points and the European Union Early Warning and Response System, and notify international partners where criteria are met.[8][62]
• Produce weekly national and regional epidemic-risk classifications based on hazard, exposure and context, to justify preparedness, response, recovery and mitigation decisions.[49]

Health-service readiness is monitored through regional implementation reporting, self-assessment, capacity mapping and web-based information systems. Regions and Autonomous Provinces must report plan implementation progress within 12 months, while a dedicated working group analyses implementation and resource needs.[25][30][54]

• Assess regional operational readiness through national procedures and self-assessment tools, including Appendices A2 and A4.[25]
• Map healthcare networks, facilities, staffing and alternative capacity, update national and regional mappings annually where required, and activate web-based systems rapidly during a pandemic.[38][63]
• Monitor service demand and resilience during the pandemic, including home care, emergency attendances, admissions, intensive-care use, recoveries and deaths; daily capacity mapping is envisaged for territorial and hospital services.[64]
• Monitor stocks, consumption and projected requirements for personal protective equipment, medicines, vaccines and medical devices as epidemiological conditions evolve.[65][66][67]

Additional monitoring arrangements include vaccination coverage and adverse-event surveillance, healthcare-associated infection surveillance, pharmacovigilance for antivirals and vaccines, training-impact assessments, and monitoring of misinformation and risk communication.[14][68][69][18][21][70]

Accountability is supported by Ministry of Health coordination, regional implementation responsibilities, operational records, formal approval processes, parliamentary scrutiny of emergency measures and public reporting of institutional action.[71][25][72]However, the material does not provide a single consolidated indicator framework, uniform reporting template, comprehensive performance targets or fully specified independent accountability arrangements across all thematic areas.[1][6][2][51]

During transition and recovery, epidemic-risk monitoring continues until the pandemic is formally concluded. In-Action Reviews and After-Action Reviews assess response activities, identify lessons and inform updates to pandemic and contingency plans.[3][24]

Costing & Financing

The plan requires preparedness and response resources but provides very limited monetary costing. It calls for regional and inter-pandemic resource estimates, dedicated pandemic funding additional to health-fund allocations, and a funded three-year monitoring, evaluation and updating plan.[25][31][55][52]

• Require Regions and Autonomous Provinces to estimate the economic resources needed to implement regional pandemic plans.[25]
• Finance regional plan requirements through specific pandemic funds additional to the National Health Fund and Regional Health Fund.[25]
• Estimate and allocate resources for inter-pandemic activities through dedicated fund distributions additional to the National Health Fund, repeating the exercise annually from 30 April 2021 for the duration of the plan.[31]
• Quantify implementation resources and secure an Italian Government commitment to additional funding for influenza-pandemic preparedness.[55]
• Fund the three-year operational monitoring, evaluation and updating plan, although no budget or financing source is specified.[52]

Resource mobilisation covers procurement, strategic stockpiles, storage and distribution of personal protective equipment, medicines, vaccines, antivirals, laboratory supplies and essential medical devices. Regional plans must address procurement and stockpiling, while national guidance supports shared strategic-stockpiling arrangements and manufacturer contracts.[25][73][74][19]

• Maintain stocks sufficient for the first three to four months of a pandemic and storage capacity for a three-month requirement of personal protective equipment, vaccines and medicines.[18][20]
• Use procurement or pre-emption contracts with manufacturers, national or regional stocks and domestic production-conversion capacity to secure critical supplies.[19][20][66][75]
• Plan resources and mobilisation mechanisms for territorial services, additional human resources, hospital capacity, diagnostic systems, telemedicine, training and emergency transport.[11][76][77][39]
• Provide financial, social, accommodation and counselling support during post-pandemic recovery, without quantified allocations.[3]

Named financing arrangements include Ministry of Health financing for event-based surveillance, central National Centre for Disease Prevention and Control financing for event-based surveillance, Ministry of Health financing through National Centre for Disease Prevention and Control projects for healthcare-associated infection control, and regular funding for distance-learning and simulation activities.[36][78][79][43][44]

Research beyond listed microbiological activities depends on dedicated research funds, and the Influnet laboratory-network updating plan is required to be adequately financed.[23][80]The plan also refers to legislative financing for risk communication and to possible economic recognition for health-sector participation in emergency interventions.[81][82]

A specific funding gap is identified for pandemic-vaccine procurement: insufficient funding prevented Italy from joining a particular European Community procurement despite its signature of the Joint Procurement Agreement in 2014.[83]Apart from this gap and the requirement for resource estimates, the material does not specify monetary amounts, currency-denominated budgets, unit costs, allocations, expenditure ceilings, economic assumptions or a comprehensive financing framework.[25][31][55][52]