COVID-19 Health System Response Monitor (HSRM) Response by the Region,

What is the COVID-19 health system response monitor?

The Health System Response monitor (HSRM) has been designed in response to the COVID-19 outbreak to collect and organize up-to-date information on how countries are responding to the crisis. It focuses primarily on the responses of health systems but also captures wider public health initiatives. This is a joint undertaking of the WHO Regional Office for Europe, the European Observatory on Health Systems and Policies and the European Commission.

1. Preventing transmission

This section on PREVENTING TRANSMISSION includes information on key public health measures that aim to prevent the further spread of the disease. It details how countries are advising the general public and people who (might) have the disease to prevent further spread, as well as measures in place to test and identify cases, trace contacts, and monitor the scale of the outbreak.

1.1 Health communication

Official advice and recommendations on hand hygiene, respiratory etiquette and physical distancing were provided from the early stages of the crisis (February 2020) through national and regional communication channels.

A daily national-level bulletin by the Department of Civil Protection, providing data about the situation in terms of the number of new cases, number of people hospitalized, death rates etc. has been released since the onset of the pandemic. Every Saturday during the lockdown period, a speech by the Prime Minister addressing the nation on the response measures adopted by the government was broadcast on television.

The President of the Veneto Region, Luca Zaia, holds frequent press conferences to inform citizens about the evolution of the situation and measures taken at regional level.

1.2 Physical distancing

On 23rd February the National Government issued a complete lockdown for ten municipalities among which was Vo’ Euganeo in the Veneto Region. On the same day, the Regional Government, in agreement with the national Ministry of Health, issued measures, closed schools and museums, banned events and mass gatherings, and limited access to visitors entering health facilities.

The National Government imposed restrictions on people's movements across the whole country on 9th March, announced the closure of non-essential commercial activities on 11th March, and closure of non-

1 essential productive activities on 22nd March. The Veneto Region further strengthened the restrictions by imposing a maximum distance of 200 meters from home for walking dogs or undertaking necessary physical activity.

A ban on outdoor sports and the closure of parks/woods were also imposed. Until 4th May free movement was banned unless the person carried a self-certified document that allowed them to move within their own municipality for three main reasons related to: urgent needs, health, and work. Law enforcement agencies were strengthened to monitor and enforce compliance.

A massive communication campaign was conducted at both national and regional level, involving institutions, well-known personalities, companies, and stakeholders, to inform all citizens about the importance and need to stay home and to follow all hygiene recommendations to protect themselves and the community from COVID-19.

1.3 Isolation and quarantine

A detailed regional protocol was developed to manage individulas seeking medical attention for suspected COVID-19 in the most appropriate healthcare settings. A hotline (800 462 340) was created by the Veneto Region to provide counselling to citizens and to carry out preliminary assessment of suspected cases and contacts of cases.

For all patients under quarantine and isolation, public health workers carry out active surveillance daily via telephone calls to assess and monitor their clinical status. Patients with mild or no symptoms are required to self-isolate at home and ae taken care of by the local healthcare services. Patients with severe symptoms, such as high fever or breathing difficulties, are admitted to hospital.

In each hospital separate pathways for access and care of suspected COVID 19 patients have been instituted. Dedicated health facilities were identified to admit COVID-19 patients and care is being provided on an ongoing basis.

Dissemination of detailed and practical guidelines on home isolation (for those not needing hospital admission) to protect other household members have also been provided in the framework of the Veneto Community-Based Strategy, and are still ongoing.

1.4 Monitoring and surveillance

The WHO definition of COVID-19 was used in the Veneto Region. COVID-19 cases were classified according to the seriousness of the illness and the health care needed in the following groups: 1) cases never admitted to hospital during the course of the illness; 2) cases admitted to non-intensive care units (ICU) wards during the course of the illness; 3) cases admitted to ICU wards during the course of illness.

Contacts of cases were categorised as “close” (high-risk exposure) and “occasional” (low-risk exposure) contacts according to the definitions provided by the European Centre for Disease Prevention and Control. All Public Health Departments of the Veneto Region’s Local Health Units provide broad contact

2 tracing for all test-positive cases, which includes extended family members, work colleagues and casual contacts (for contact greater than 15 minutes).

A centralised surveillance system was created to monitor the epidemic trend and to track the pathways of COVID-19 cases in healthcare facilities, both for epidemiological and healthcare planning purposes. Data were gathered through a web-based application fed by reports of SARS-CoV-2 tests performed in all of the Region’s laboratories. Clinicians and public health professionals can access this web-based application to retrieve laboratory results and to enter data on exposure history, clinical conditions, and hospitalisation history of infected subjects.

Another web-based application was developed for contact tracing and management and linked to the previous one. This software allows the insertion of lists of contacts, the creation of links between cases and their contacts, and the management of all activities related to active surveillance and quarantine.

1.5 Testing

The testing and contact tracing strategy has evolved progressively during the epidemic. Until 21st February 2020, according to national protocols, a suspected SARS-CoV-2 case was defined as a patient with both acute respiratory symptoms and history of travel to China in the previous 14 days or an epidemiological link with China or with a confirmed case. Following the detection of the first locally- acquired case, regional protocols were quickly updated to improve the sensitivity of the surveillance system and actions were taken by each Local Health Unit to improve contact tracing. Since 28th February 2020, testing for SARS-CoV-2 has been recommended, in addition to the previous criteria, also for any patient with severe acute respiratory infection or acute respiratory distress syndrome, as well as for patients with acute respiratory symptoms or an influenza-like illness who were close contacts of a suspected, probable or confirmed case. Asymptomatic close contacts were traced and put under quarantine for 14 days since the last contact date. As the epidemic progressed close contacts of positive cases were also tested. Since 17th March 2020, casual contacts are also put in quarantine.

Tests can be performed following epidemiological investigation conducted by Public Health Services of the Prevention Departments and/or on requests /prescription by General Practitioners, Paediatricians or Specialist Doctors.

Testing for SARS-CoV-2 was carried out on upper or lower respiratory samples by real time RT-PCR targeting two different SARS-CoV-2 genes, according to WHO recommendations. During the initial phase of the outbreak, all tests were carried out by the Regional Reference Laboratory at the University of Padova and samples were sent for confirmation to the National Reference Laboratory at the National Institute of Public Health (Istituto Superiore di Sanità), Rome.

To face increasing diagnostic demand, laboratory capacity was expanded by acquiring new instruments and authorising more laboratories to perform the test, under the supervision of the Regional Reference Laboratory. Fourteen laboratories have been identified for diagnostics. The laboratories of the Azienda Ospedale Università di Padova (ie. The Hospital Trust of Padova) are committed to carrying out swabs on individuals working for the Essential Services ((eg. firefighthers, policeman, military services, etc.) and to supporting the other Local Health Units in the Region. The implementation of this activity involves the

3 strengthening and/or construction of operating modules that each cover the region’s different provinces. In the case of Padova, the operating module has been realized by increasing the capacity of the Microbiology Department of Padova University Hospital from about 1500 to 3500 samples per day.

Microbiological tests for the direct detection of SARS-CoV-2 are carried out at the following public laboratories

Laboratory Director Laboratorio di Virologia, Dipartimento Medicina Molecolare, Dr. Andrea Crisanti Università degli Studi di Padova Microbiologia e Virologia, Azienda Universitaria Integrata di Verona, Prof. Giuseppe Cornaglia Ospedale Borgo Roma UOSD Laboratorio, ULSS 1 Dolomiti (Belluno) Dr.ssa Eliana Modolo UOC Microbiologia, ULSS 2 Marca Trevigiana (Treviso) Dr. Roberto Rigoli UOC Microbiologia, Ospedale dell'Angelo, ULSS 3 Serenissima Dr. Claudio Scarparo (Mestre) UOC Medicina di laboratorio, ULSS 5 Polesana (Rovigo) UOC Microbiologia, Ospedali Riuniti Padova Sud, ULSS 6 Euganea Dr. Fabio Manoni VENETO (Schiavonia) Region UOC Medicina di Laboratorio, Ospedale San Bassiano, ULSS 7 Dr. Antonio Antico Pedemontana (Bassano del Grappa) UOC Microbiologia, ULSS 8 Berica (Vicenza) Dr. Mario Rassu UOC Laboratorio Analisi di Legnago, ULSS 9 Scaligera (Legnago) Dr. Stefano Badocchi UOSD Laboratorio Analasi di San Bonifacio, ULSS 9 Scaligera (San Dr.ssa Novella Scattolo Bonifacio) UOS Laboratorio Analisi di Villafranca, ULSS 9 Scaligera (Villafranca di Dr.ssa Marilia Visconti Verona) Laboratorio diagnostica, Istituto Zooprofilattico Sperimentale delle Dott.ssa Antonia Ricci Venezie (Padova) IRCCS per le Malattie infettive e tropicali Ospedale Sacro Cuore Don Dr. Zeno Bisoffi Calabria di Negrar Dr.ssa F. Perandin

These laboratories have carried out an average of 13 000 test per day during late phase 1 and phase 2. During the peak period of the epidemic, it took, on average, no longer than five days to obtain test results. The timeframe depended on the priority of the request and seriousness of the illness and on the number of tests performed during a single day. At present the results are provided within 24 hours.

2. Ensuring sufficient physical infrastructure and workforce capacity

ENSURING SUFFICIENT PHYSICAL INFRASTRUCTURE AND WORKFORCE CAPACITY is crucial for dealing with the COVID-19 outbreak, as there may be both a surge in demand and a decreased availability of health workers. This section considers the physical infrastructure available in a country and where there are shortages, it describes any measures being implemented or planned to address them. It also considers the health workforce, including what countries are doing to maintain or enhance capacity, the

4 responsibilities and skill-mix of the workforce, and any initiatives to train, protect or otherwise support health workers.

2.1 Physical infrastructure

At the beginning of the epidemic, supplies were those foreseen for ordinary activity. From the outset, efforts were made to secure PPE, ventilators and drugs as soon as possible to deal with the emergency (in particular, the procurement and distribution of PPE and the adoption of therapeutic and pharmacological schemes with clinical evidence). On 28th March 2020 the Veneto Region reached the peak of patients in ICU (359) or in sub-intensive care units (215). To reduce pressure on ICUs, the number of ICU beds was almost doubled and sub-intensive care units were activated for non-invasive ventilation treatment of COVID-19 patients with respiratory failure. There was never any lack of ICU beds or sub-intensive care unit beds during phase 1 and phase 2. All Local Health Units in the Veneto Region have a Public Health Department (total of 9) responsible for coordinating of all public health actions to address and control the spread of SARS-CoV-2.

The organisation of the health system and the strength of the region’s public health infrastructure ultimately appear to have played an important role in the region’s outcomes. Health authorities in the Veneto Region identified specific hospitals and convalescent centres that would care for COVID-19 cases. Strong and aggressive public health efforts to confirm and isolate cases and contacts in a timely way and to minimize unnecessary contact between health care workers and cases through home-based testing and pro-active home follow-up were implemented. Daily surveillance and contact tracing was carried out by the health personnel of Prevention Departments. Bed availability monitoring was implemented in the local health units and hospitals in collaboration and under the supervision of the Regional leadership.

2.2 Workforce

All non-urgent public health activities normally carried out by Prevention Departments were promptly put on hold to carry out all necessary actions to address COVID-19. At the peak of the epidemic in the Veneto Region, the staff of the Prevention Departments amounted to a total of 680 health workers, of which 120 were medical doctors, 32 post-graduated physician trainees, 43 medical or nurse students, 213 health assistants, 157 nurses, 38 prevention technicians, 31 other health care workers, 33 administrative staff. Around 10 000 frontline health workers have been involved in providing direct health services to Covid-19 patients in a number of settings (see also Section 4.1 on Financing).

The measures implemented for the entire regional Health Service concerned 1) recruiting health personnel and specialist doctors; 2) conferring professional assignments; 3) increasing the work hours of specialists and increasing personnel contracts using professionals and facilities affiliated with the Health Service. A total additional expenditure of approximately EUR 120 million, deriving from an increase in the National Health Fund (Relaunch Decree), were also used.

Specific Regional Coronavirus Procedures (SARS-CoV-2) were defined to establish how healthcare professionals should intervene and manage cases in different healthcare settings and facilities, defining individual roles and responsibilities. Regarding health care workers, a guideline was published by the Region for the following scenarios:

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● when health workers came into contact with a confirmed case of COVID-19 without the use of the recommended personal protective equipment (PPE); ● how to screen for SARS-CoV-2 in health personnel; ● indications on the use of personal protective equipment.

Further details are available at: https://www.regione.veneto.it/web/sanita/covid-19-documenti- regionali-operatore

Particular attention has been placed on training at both national and regional levels. Free distance training courses (FAD), related to the emergency of COVID-19 aimed at all operators of the Health Service, are provided by the National Institute of Health (Istituto Superiore di Sanità) through the Eduiss platform and by the Veneto Region’s School of Public Health (Fondazione Scuola di Sanità Pubblica).

To ensure psychosocial and occupational health support for health workers, different initiatives have been put in place:  a hotline for health workers (800 33 43 43);  an online platform providing psychological assistance is offered to all health workers by the University of Padova;  the Hospital Psychology Service of one of the region’s Local Health Units (ULSS 9 Scaligera) is committed to supporting health and administrative operators through individual psychological support.

3. Providing health services effectively

This section on PROVIDING HEALTH SERVICES EFFECTIVELY describes approaches for service delivery planning and patient pathways for suspected COVID-19 cases. It also considers efforts by countries to maintain other essential services during periods of excessive demand for health services.

3.1 Planning services

Healthcare services were reorganised to avoid any unnecessary and non-urgent access to healthcare facilities by patients and to devote most healthcare resources to the management of the epidemic. Non-urgent visits and surgical operations were suspended and direct access of patients to general practitioners and to Emergency Departments was discouraged. General practitioners were recommended to limit office visits by replacing them with phone assessments, followed by home visits whenever necessary.

The Veneto Region’s greater level of integration between its public health and hospitals services at local level and strong public health infrastructure appear to have played an important role in the success of its COVID-19 response strategy. Specific COVID-19 hospitals and convalescent hospitals for patients no longer requiring acute care were created in the first weeks of the pandemic in Veneto Region. Departments of Prevention in each Local Health Unit were strengthened with additional staff to prevent the further spread of the COVID-19 virus.

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There is a tight integration of hospital care, primary care and social services. The Region made the choice to hospitalize as little as possible by strengthening home-based care with special continuity of care units, in collaboration with the Department of Prevention and general practitioners.

3.2 Managing cases

The first point of contact, in case of symptoms or any concerns, is the general practitioner, the doctor on call or by calling the free phone numbers listed below: ● In Veneto Region the telephone helpline is: 800 462 340; ● The national COVID-19 information hotline set up by the Ministry of Health: 1500; ● Emergency Numbers: 112/118.

General Practitioners have been involved to respond to patients who present respiratory symptoms. GPs were asked to perform a telephone triage and visit symptomatic subjects at home, in order to prevent these patients going directly to the clinic or to hospital emergency wards, with the risk of further spreading the virus.

Separate pathways to access the facility and to deliver care to COVID-19 patients (and suspected cases) have been put into place in each hospital.

The Veneto Region has adopted a protocol to start testing some medications directly at home, using a procedure developed by the COVID-19 Task Force’s Scientific Committee activated by the Region. Among these therapies are: Tocilizumab and Avigan, as well as Chloroquine / Hydroxychloroquine, Lopinavir/Ritonavir, Duranavir/Ritronavir, Remdesivir (see: https://www.regione.veneto.it/article- detail?articleId=4441190 ).

3.3 Maintaining essential services

Italy developed an overarching national strategy for the COVID-19 response and implemented a national lockdown on 12th March, 2020. Within these broad guidelines, each region developed a response plan that took into account the strengths and weaknesses of its health care and public health services.

The Veneto Region has defined an "anti-coronavirus plan", called "COVID-19 Epidemic - Urgent Public Health Interventions" with the aim of interrupting the circulation of the SARS-COV-2 virus. The plan was implemented with the support of the University of Padova, the Red Cross and Department of Civil Protection. The strategies in the Plan are:

● identifying all possible suspicious, probable and confirmed cases; ● providing for all contacts quarantine measures and fiduciary home isolation; ● reorganizing the activity of the Prevention Departments in support of the COVID-19 emergency; ● screening all employees of the Regional Health System (SSR), General Practitioners, Pharmacists, health workers in nursing homes; ● identifying possible COVID-19 cases among workers of the Essential Services (eg. firefighthers, policeman, military services, etc.).

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No health care services have been rationed and essential non-COVID-19 related care is available through the regional health system to those who need it.

Services and assistance are being provided for specific populations that are particularly vulnerable. At national level the Office for Disability Policies publishes specific updates on the procedures and services applicable to people with disabilities relating to the COVID-19, available online at: http://disabilita.governo.it/it/notizie/nuovo-coronavirus-domande-frequenti-sulle-misure-per-le- persone-con-disabilita/

Moreover, a specific regional public health intervention has been developed to support vulnerable people at home with care needs, and in particular nursing homes and long-term care facilities, in collaboration with the Department of Public Health, General Practitioners and Primary Health Care services.

In terms of psychological support, among the various initiatives to deal with the multiple effects of the coronavirus emergency, a toll-free number - 800 33 43 43 (InOltre Service) - has been made available in the Veneto region. The operators are psychologists with expertise in the management of emergencies and changes in the community; they suggest support pathways aimed at defining both objectives and strategies to manage difficulties, as well as identify for callers the various tools and resources that they may find useful and necessary.

A national telephone helpline also is available: 800.833.833. The first level is a telephone consultation that aims to respond to people’s problems related to dealing with the COVID-19 situation (there are over 500 emergency psychologists who are part of the Civil Protection Volunteer Associations). Subsequently, if necessary, calls are forwarded to the second level of assistance, based on the specifics of the caller’s problem (with more than 1500 psychotherapists available).

4. Paying for services

Adequate funding for health is important to manage the excess demands on the health system. This section considers how countries are PAYING FOR COVID-19 SERVICES. The subsection on health financing describes how much is spent on health services, where that money comes from, and the distribution of health spending across different service areas. The section also describes who is covered for COVID-19 testing and treatment, whether there are any notable gaps (in population coverage and service coverage), and how much people pay (if at all) for those services out-of-pocket.

4.1 Health financing

An additional total budget of approximately €120 million, resulting from an increase in the National Health Fund, was provided by the region to support the COVID-19 emergency. At the end of April 2020, the costs incurred to manage the epidemiological emergency caused by COVID-19, used for the purchase of PPE, medical equipment, strengthening of health facilities and assistance to the population by the Civil Protection Department, amounted to approximately €140 million.

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Many donations came from the region’s population for which a special bank account has been created and is managed by the Region (email address: [email protected] ). As of 21st April 2020, donations had reached € 57 million.

Furthermore, an additional payment of €1200 has been paid to health workers and technicians directly involved in the care of COVID-19 patients, including those who themselves contracted the virus and had to undergo treatment and/or quarantine with active surveillance. The recipients amount to approximately 10 000 employees working in the following services: hospitals converted for COVID-19 patients; Intensive Therapies and Operating Units recognized as sub-intensive units during the COVID-19 emergency period: infectious diseases, pneumology, First Aid, Emergency Medical Services/ambulance personnel (SUEM 118); those working in fully or partially converted wards for COVID-19 care; other services where it is possible to identify personnel dedicated to activities specifically established to deal with the COVID -19 emergency, dedicated to patients or suspected cases. Up to €600 has been paid to other operators involved in activities related to emergency support. There are also plans to extend the "Infectious Diseases" allowance of €5.16 for each day worked in COVID-19 wards and in related services, and the so-called "Sub Intensive" allowance of € 4.16 per day.

4.2 Entitlement and coverage

Necessary care and treatments in the Veneto Region are available for all patients, including COVID-19 patients, with no rationing of care.

Urgent and essential health services are provided free of charge to all people regardless of nationality or economic status, especially for infectious disease that can impact on public health. Undocumented migrants also are covered (see: https://temi.camera.it/leg18/temi/emergenza-da-covid-19-le-misure-in- materia-di-immigrazione)

5. Governance

The GOVERNANCE of the health system with regard to COVID-19 relates to pandemic response plans and the steering of the health system to ensure its continued functioning. It includes emergency response mechanisms, as well as how information is being communicated, and the regulation of health service provision to patients affected by the virus.

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In 2007 the Veneto Region defined a specific plan to address a possible flu pandemic. In 2012 an organizational model was developed for each Local Health Unit, in order to be prepared for any possible infectious disease emergency.

On 30th January 2020, a regional Task Force coordinated by the regional Directorate of Prevention, Food Safety, and Veterinary Public Health, and composed of experts in public health, infectious diseases, virology, emergency medicine, and intensive care medicine, was established to coordinate the response to the COVID-19 threat. After the emergence of the outbreak in the Veneto Region, a Scientific Committee was established to support the Task Force in the elaboration of protocols and guidelines:

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● National level - http://www.governo.it/it/coronavirus-normativa ● Regional level - https://www.regione.veneto.it/web/sanita/covid-19-provvedimenti-regionali- operatore

The coordination of surveillance at national level is entrusted to the National Health Institute (Istituto Superiore di Sanità), which collects reports from the regions through a dedicated web platform. Monitoring and screening are implemented under the coordination of the national Ministerial Task Force. On 31st January, 2020, the Council of Ministers declared a six- month state of emergency as a consequence of the health risk related to the Coronavirus outbreak. The Head of the national Department of Civil Protection, Angelo Borrelli, is entrusted with coordination of the interventions necessary to deal with the emergency across the country. The main actions coordinated concern assistance to the population potentially affected by the virus, the strengthening of controls in airports and port areas according to the measures adopted by the Ministry of Health, the repatriation to Italy of citizens located in countries at risk and the return of foreign citizens exposed to risk to their home countries.

The European Commission has adopted EU Recommendation 2020/403 on conformity assessment and market surveillance procedures in the context of the COVID-19 threat and published the Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context. The latter document, in the form of a Q&A (questions and answers), provides guidance on various points related to medical devices including: legal requirements for placing on the market and verification of conformity, derogation procedures and the use of harmonised standards. In addition, a list of the most relevant harmonised standards for medical devices relevant to COVID-19 is annexed to the guideline, which gives the devices a presumption of conformity with the essential requirements laid down in the Directives. Article 11, paragraph 13, then states that a Member State may, for health protection purposes, authorise the placing on the market in the territory of the Member State concerned of individual devices for which conformity assessment procedures have not yet been carried out. The EU document clarifies that the COVID-19 epidemic is to be considered a justified circumstance for this purpose. This derogation has also been applied in Italy and more clarifications are available in the Circular of the 5 May 2020 of the Ministry of Health: http://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2020&codLeg=74035&parte=1 %20&serie=null

6. Measures in other sectors

Many MEASURES IN OTHER SECTORS beyond the immediate scope of the health system are being taken to prevent further spread of the virus. This section contains information on many of these areas, including border and travel restrictions and economic and fiscal measures, among others.

Borders and internal mobility

A series of lockdowns were imposed starting 23rd February, 2020 in parts of the Veneto region, and then extended across the entire country on 11 March. From the 18th May, 2020 these were gradually lifted, allowing travel within regions, and from 3rd June also permitting movement between regions.

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Also from 3rd June, 2020, travel to and from other countries is permitted. Movements may only be restricted by measures taken in relation to specific states and territories, in accordance with the principles of adequacy and proportionality to the epidemiological risk and in compliance with the constraints arising from EU law and international obligations. At the moment, there are no areas in lockdown in the Veneto Region.

Reference http://www.viaggiaresicuri.it/approfondimenti-insights/saluteinviaggio

Economy and state aid

A national decree was adopted by the national government concerning measures to strengthen the National Health Service and economic support for families, workers and businesses related to the COVID-19 epidemiological emergency. Details may be found at:

https://www.gazzettaufficiale.it/eli/id/2020/03/17/20G00034/sg

The national government has introduced a series of measures in favour of families and businesses in order to contain the economic damage caused by the COVID-19 emergency (eg. encouraging smart working practices such as working from home wherever possible, online schooling at home, financial aid for families with children, economic support for workers and enterprises, etc.).

Civil protection

A national State of Emergency was declared the 31st of January, 2020 for a period of 6 months.

References https://temi.camera.it/leg18/temi/misure-fiscali-e-finanziarie-per-l-emergenza-coronavirus.html https://temi.camera.it/leg18/temi/flessibilit-degli-aiuti-di-stato-nell-attuale-epidemia-da-covid.html http://www.protezionecivile.gov.it/

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