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Summary

Italy’s Constitution recognizes the protection of health as a fundamental individual right and public interest, and also enshrines the principle of respect for the human personality.  Within this constitutional framework, the Consolidated Health Laws and various other legal and regulatory provisions assign responsibility for confronting health crises to national and regional authorities, authorize measures to address infectious and communicable diseases, establish a reporting system, and grant authority for the issuance of special orders when the nation is threatened with an epidemic.  The Minister of Health and the National Health Service play leading roles in this field.  Freedom of information, including access to public health information, is constitutionally guaranteed.  Italy actively cooperates with the World Health Organization, European institutions, and other international organizations.

Given Italy’s geographic proximity to Africa, recent parliamentary debates about the Ebola epidemic in Africa have centered on the country’s immigration policies.  The Health Ministry has now updated its protocols and guidelines concerning preventative and response measures vis-à-vis Ebola.  These guidelines set forth measures addressing the treatment of suspected, probable, and confirmed cases of Ebola; sanitation and decontamination; the disposal of waste; and the handling of corpses.  Most regions follow the Ebola protocols established at the national level.

I.  Government Structure

Italy is a democratic republic whose president is the Head of State.  The executive power resides in the Council of Ministers, which is headed by the Prime Minister (officially referred to as the President of the Council of Ministers).  Legislative power is exercised jointly by the Chamber of Deputies and by the Senate.  The judicial branch is an autonomous order independent from any other power.  The territory of the Republic is divided into twenty regions and further into provinces and municipalities.

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II.  Structure of Public Health Crisis Management System

Health protection and the handling of public health crises in Italy are regulated by statutory and regulatory provisions based on the constitutional principle of the protection of health as a fundamental individual right and a public interest.  The Constitution further states that health treatments may be imposed by law only if they do not violate the principle of respect for the human personality.[1]

Italy’s National Health Service, under the Ministry of Health, aims at ensuring the sanitary and epidemiological well-being of the whole population.  It assures the coordination of all activities and interventions of agencies, institutions, and services that perform any duty concerning individual and collective health.  The central and local governments are jointly responsible for the implementation of the National Health Service.  The law provides health authorities with the necessary powers to perform mandatory health controls and treatments.[2]

The Consolidated Health Laws contains specific provisions concerning infectious diseases.  It establishes that the Minister of Health may, on the advice of the Superior Council of Health, issue a list of infectious and communicable diseases subject to special procedures and measures.[3]  The Act imposes a system of reporting such diseases through the various levels of responsible authorities up to the Minister of Health.  It provides for preventative measures, necessary assistance, and disinfection interventions for such diseases.  It further grants the Minister of Health, when the nation is threatened with an infectious disease epidemic, the authority to issue special orders for the inspection and disinfection of premises, the organization of special services and medical assistance, and the adoption of protective measures against the spread of such diseases.  The ordinances of the Minister are published in the Official Gazette.  Under the provisions concerning veterinary regulations, the Act requires coordination between the Municipal Veterinary Office and the Municipal Health Office for the reporting of animal diseases that can be transmitted to humans.[4]

Preventing, monitoring, and responding to public health emergencies including epidemics, even when caused by terrorists, is the responsibility of government officials and civil servants at the central, regional, and municipal levels.  The Minister of Health assesses and makes decisions concerning situations of national crisis, and issues the ordinance that triggers the response to a specific emergency.[5]  The Civil Protection Department, under the supervision of the Prime Minister or the duly delegated Interior Minister, deals with emergencies that are the result of natural disasters or the consequence of human activities, as well as other events that, because of their intensity and scope, require the coordinated intervention of public authorities at the central and local government levels.[6]

Under legislation enacted in 1998,[7] urgent interventions in cases of health emergencies can be made by regional and local authorities.  The intervention of the central government authorities takes precedence according to the relevance and the magnitude of the emergency.[8]  The Prime Minister may appoint a special commissioner when a state of emergency has been declared.[9]

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III.  Powers of Public Health Authorities

Article 32 of the Italian Constitution states that no one may be forced to receive medical treatment unless provided for by law, and that the law may not violate limits imposed by respect for the human personality.  The powers granted to public health authorities to adopt a range of protective measures against the spread of disease in a health crisis, such as mandatory medical treatments, are limited by the constitutional guarantee of respect for the human personality and, to some extent, in the application of the law protecting privacy.[10] One author has observed that the Italian Constitution appears to favor the collective public health interest as opposed to the individual’s interest when it comes to protection from epidemics and infectious diseases.[11] 

Health authorities may impose stricter controls on travelers coming from areas at risk, require air or other carriers to provide detailed information regarding their passengers’ itineraries, impose health checks, and require hospitalization for infected persons.  International preventive measures and public hygiene measures concerning imported goods, travelers, and migrants are carried out by the health authorities set up by the Ministry of Health at the territorial borders, ports, and airports.[12]

Italy’s public health laws provide for the imposition of administrative and penal sanctions, including terms of imprisonment, for noncompliance.  Punishable conduct includes failure to provide assistance in emergency health situations, especially for health professionals; violations of reporting procedures; and failure to abide by a lawful order of the authority in a health crisis.[13]  In addition, the Italian Penal Code makes causing an epidemic by spreading noxious germs a crime punishable by life imprisonment.[14]

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IV.  Transparency of Public Health Crisis Management System

The right of the public to access official information is a fundamental right provided in article 21 of the Italian Constitution.

Decisions by the Italian Constitutional Court under article 21 have emphasized not only the freedom to provide and divulge news, opinions, and comments, but also the right to obtain information.  This interest implies a plurality of sources of information, free access to them, and the absence of unjustified legal obstacles, even temporary ones, to the circulation of news and ideas.[15]

The Consolidated Health Laws reserves to the central government the administrative duties and responsibilities concerning the functioning of the national Health Information System.  The central government is also required to coordinate (1) the regional information systems in cooperation with public and private entities, (2) statistical analysis of the data disseminated, (3) information to be provided to Parliament, and (4) any other reporting of national relevance.[16]  Especially during a public health crisis, the Minister of Health issues directives and disseminates information through any appropriate means, including its website.[17]  Health information is further disseminated by newspapers and public and private radio and television stations.

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V.  Cooperation with the WHO

The Italian government works closely with the WHO in meeting public health crises.  The Ministry of Health, through its website, keeps the public informed of international developments and of WHO standards and guidelines.[18]

Italy enacted legislation implementing the International Health Regulations of 1969 as amended in 1973.[19]  Italy is also a party to the International Health Regulations of 2005.[20]

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VI.  Response to Ebola Virus Epidemic in West Africa

A.  National Measures

In response to the Ebola epidemic in West Africa, the Italian Ministry of Health issued a Circular on April 4, 2014, recommending the “adoption of all useful surveillance actions related to indirect arrivals” from Guinea and other bordering countries where symptoms of Ebola have been found.[21]  While the Circular seeks to minimize the danger of Ebola spreading in Italy, key government ministries and agencies have nonetheless been alerted, including the Italian Red Cross.[22]

On May 14, 2014, the Italian Chamber of Deputies held a parliamentary debate to review the preparedness of Italy’s health system to prevent and fight Ebola.[23]  The debate highlighted the fact that during the months prior to May 2014, Italy witnessed a growing influx across its southern border of thousands of illegal African immigrants, many of whom came from the Ebola-affected areas of West Africa.  During the debates, many participants argued this situation required action from the National Government, in particular from the Health Ministry, to address illegal immigration, as well as to provide the public with transparent and prompt information, especially to protect school children.  Some participants in this session proposed that the government impose a sanitary cordon throughout the country to protect the population, but the government has not adopted this proposal.

The Health Ministry responded to the parliamentary inquiry by requiring immigrants arriving at coastal areas of Italy to undergo thorough clinical evaluations to exclude the presence of signs or symptoms of Ebola before they reach immigration centers.[24]  Isolation measures are implemented when necessary.[25]  Immigration centers are also staffed with sanitary personnel whose function is to ensure the adequate flow of information to and from the Health Ministry, and to adopt immediate measures when specific dangers to public health are involved.[26]

While parliamentary debate has generated new regulations, no specific legislative bills containing extraordinary measures to address the Ebola epidemic have yet been introduced in Italy.

On October 14, 2014, the National Institute for Infectious Diseases (Istituto nazionale per le malattie infettive, Lazzaro Spallanzani), updated its Operational Procedures for the Management of Suspected, Probable, or Confirmed Cases and Contacts of the Ebola Virus Disease in Western Africa (the Procedure).[27]  The Procedure contains three parts: the first describes the Ebola virus disease; the second regulates the treatment of Ebola patients; and the third deals with other stages in the treatment of the disease, including disinfection and sanitation, waste treatment, disposal corps, and surveillance of health personnel.

In the case of suspected patients, health personnel must observe a series of guidelines concerning the sanitation of the areas exposed to the patient, his or her transfer to an isolated room or facility, and his or her immediate treatment by a qualified physician.[28]  Suspected patients may be repatriated from overseas or transferred to another specialized facility at the national or regional levels.[29]

The treating physician must issue a diagnostis of the patient as “nonsuspected,” or suspected of low or high risk.[30]  If the patient is characterized as of low or high risk, he needs to be treated in a facility devoted to the treatment of infectious diseases.[31]  The sanitation procedures for the facilities used for the patient must be strictly followed in order to avoid contaminating other patients.[32]

The test for Ebola virus must be carried out only on suspected patients.[33]  If the test is negative, and the symptoms remain for at least forty-eight hours, caution must be observed in the handling of the patient until the test is repeated.[34]  If the test results are negative a second time, then the patient is moved to a recovery unit.[35]

The Procedure states that there are no international guidelines, criteria, or procedures for the release of patients.[36]  However, based on the Institute’s experience and observations of comparable scenarios, the Procedure establishes two concurrent criteria that must be met for the release of patients: (i) when the patient is in a good and stable clinical condition; and (ii) when at least two Ebola virus tests have been applied to the patient in a space of at least twenty-four hours, with negative results.[37]  Diagnostic activities performed at laboratories must meet specified minimum requirements.[38]  Samples taken from the patient are subject to the “rule of triple packaging,”[39] and transportation of samples is subject to stringent rules.[40]

Finally, the Procedure lists stringent measures in case of the death of the patient,[41] and the sanitation and decontamination of health personnel.[42]

The Italian Health Ministry is permanently updating its information concerning the Ebola epidemic.[43]

B.  Regional Measures

Ebola virus protocols at the regional level follow the guidelines issued by the National Health Ministry.  For example, the Lazio Region (where Rome, Italy’s capital, is located) has issued a Regional Protocol for the Ebola Virus Epidemics in Western Africa: Indications for Surveillance and Control.[44]  This Protocol states that it was written “based on the indications received from the national Health Ministry issued pursuant to a central protocol for the management of suspected/probably/confirmed cases of [Ebola], including their contacts.”[45]

Prepared by Dante Figueroa
Senior Legal Information Analyst*
February 2015


* This report updates a report originally prepared by former Senior Legal Specialist Giovanni Salvo in 2003, which was previously updated in 2009 by Senior Legal Research Analyst Constance A. Johnson.

[1] Constitution of the Italian Republic art. 32, https://www.senato.it/documenti/repository/istituzione/ costituzione_ inglese.pdf (English version published by the Parliamentary Information, Archives and Publications Office of the Senate Service for Official Reports and Communication of the Senato della Repubblica, Apr. 2009).

[2] Legge 23 dicembre 1978, n. 833, Istituzione del servizio sanitario nazionale [Law No. 833 of December 23, 1978, National Health Service Institution], Gazzetta Ufficiale della Repubblica Italiana [G.U.] No. 360, Dec. 28, 1979, http://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:legge:1978-12-23;833.

[3] Id. arts. 9 & 62.

[4] Royal Decree No. 1265 of July 27, 1934, as amended, approving the Consolidated Health Law, in Codice della Sanita’ (Torino, UTET 1999).

[5]Law No. 833. See also Ordinanza 10 Apr. 2003 of the Minister of Health, G.U. No. 89 of Apr. 16, 2003; Decreto-Legge 9 maggio 2003 No. 103, Disposizioni urgenti relative alla sindrome respiratoria acuta severa (SARS) [Decree-Law No. 103 of May 9, 2003, Urgent Provisions Related to the Severe Acute Respiratory Syndrome (SARS)], G.U. No. 108, May 12, 2003, http://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto. legge:2003;103 (concerning urgent provisions for the SARS syndrome).

[6] In addition to the existing body of laws on Civil Protection (Codice della Protezione Civile, Piacenza, La Tribuna, 2002), see Decree of the President of the Republic, Mar. 27, 1992, Course of Action and Coordination for the Regions for the Purpose of Determining Levels of Health Assistance During Emergencies, G.U. No. 76 of Mar. 31,1992;Agreement Between the State and the Regions Approving Guidelines on the Health Emergency System Pursuant to the Decree; Decree of Feb. 13, 2001, on Adoption of General Criteria for the Organization of Health Relief in Disasters; Law No. 401 of Nov. 9, 2001, G.U. No. 262 of Nov. 11, 2001; Legge 9 novembre 2001, n. 401, Conversione in legge, con modificazioni, del decreto-legge 7 settembre 2001, n. 343, recante disposizioni urgenti per assicurare il coordinamento operativo delle strutture preposte alle attivita’ di protezione civile [Law No. 401 of Nov. 9, 2001, Conversion into Law, with Amendments, of Decree-Law No. 343, Sept. 7, 343, Concerning Provisions for the Operational Coordination of the Structures of Civil Protection and Improving Logistics of Civil Defense], G.U. No. 262 of Nov. 11, 2001, http://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:legge:2001;401; Decree of Mar. 2, 2002, G.U. No. 66 of Mar. 19, 2002, Establishing the Operational Committee for Civil Protection.

[7] Decreto Legislativo 31 marzo 1998, n. 112, Conferimento di funzioni e compiti amministrativi dello Stato alle regioni ed agli enti locali, in attuazione del capo I della legge 15 marzo 1997, n. 59 [Legislative Decree No. 112 of March 31, 1998, Granting Administrative Powers and Competences of the State to the Regions and Local Entities, in Accordance with Chapter I of Law No. 59, of March 15, 1997], G.U. No. 92, Apr. 21, 1998, http://www.normat tiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legge:1998-03-31;112vigSee also Decreto Legislativo 18 agosto 2000, n. 267, Testo unico delle leggi sull’ordinamento degli enti locali [Legislative Decree No. 267 of August 18, 2000, Approving the Consolidation Act of Provisions Governing Local Administrative Bodies], G.U. No. 227, Sept. 28, 2000, http://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2000-08-18;267.

[8] Consolidated Health Laws art. 49.

[9] Decreto del Presidente del Consiglio dei Ministri 28 marzo 2003, Dichiarazione dello stato di emergenza in relazione alla tutela della pubblica incolumita’ nell’attuale situazione internazionale [Decree of the President of the Council of Ministers of March 28, 2003, Declaration of State of Emergency with Relation to the Protection of Public Safety in the Current International Situation], G.U. No. 74, Mar. 29, 2003, http://www.protezionecivile.gov.it/ cms/attach/decreto_28marzo2003.pdf; Ordinanza del Presidente del Consiglio dei Ministri 30 aprile 2003 n. 3285, Concerning Further Measures of Civil Protection for the International Health Emergency, G.U. No. 106, May 9, 2003, http://www.protezionecivile.gov.it/cms/attach/ordinanza3285del30.pdfSee also Ordinanza 28 marzo 2003 n. 3275, Disposizioni urgenti di protezione civile per fronteggiare l’emergenza derivante dalla attuale situazione internazionale [Ordinance No. 3275, of March 28, 2003, Urgent Provisions of Civil Protection to Face the Emergency Deriving from the Current International Situation], G.U. No. 74, Mar. 29, 2003, http://www.ambiente diritto.it/Onlus/2003/opcm%202003%20n.3275.htm; Ordinanza del Presidente del Consiglio dei Ministri 18 aprile 2003 n. 3282, Disposizioni urgenti di protezione civile [Ordinance No. 3282 of the President of the Council of Ministers of April 18, 2003, Urgent Provisions for Civil Protection], G.U. No. 99, Apr. 30, 2003, http://www.gaz zettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2003-04-30&atto.codiceRedazionale=03A05416&elenco30giorni=false.

[10] Legge 31 dicembre 1996, n. 675, Tutela delle persone e di altri soggetti rispetto al trattamento dei dati personali [Law No. 675 of December 31, 1996, Protection of the Person and other Subjects Concerning the Treatment of Personal Data], G.U. No. 5, Jan. 8, 1997, http://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:legge:1996;675; Decreto Legislativo 11 maggio 1999, n. 135, Disposizioni integrative della legge 31 dicembre 1996, n. 675, sul trattamento di dati sensibili da parte dei soggetti pubblici [Legislative Decree No. 135 of May 11, 1999, Supplementary Provisions of Law No. 675, of December 31, 1996, http://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:1999;135.

[11] See generally La Privacy nella sanità [Privacy in Health], Diritto e Risposte, http://www.dirittierisposte. it/Schede/Tutela-della-privacy/Diritti/la_privacy_nella_sanita_id1129480_art.aspx (last visited Nov. 6, 2014).

[12] Regio Decreto 30 marzo 1942, n. 327 Approvazione del testo definitivo del Codice della Navigazione [Royal Decree No. 327 of March 30, 1942, Approving the Final Text of the Navigation Code], G.U. No. 93, Apr. 18, 1942, http://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:regio.decreto:1942-03-30;327.

[13] Codice penale [C.P.] [Penal Code] art. 415, available at http://www.altalex.com/index.php?idnot=36766.

[14] Id. art. 438.

[15] Italian Constitutional Court, Decision No. 105 of 1972, Consulta Online, http://www.giurcost.org/decisioni/1972/ 0105s-72.html.  In Decision No. 112 of 1993, http://www.giurcost.org/decisioni/1993/0112s-93.html, the Court, referring to its established interpretation of article 21, recognized the existence of a full, individual right to be informed.

[16]Consolidated Health Laws art. 118.

[17] Ministero della Salute, http://www.sanita.it (last visited Nov. 5, 2014).

[18] Id.

[19] Legge 9 febbraio 1982, n. 106 Approvazione ed esecuzione del regolamento sanitario internazionale, adottato a Boston il 25 luglio 1969, modificato dal regolamento addizionale, adottato a Ginevra il 23 maggio 1973 [Law No. 106 of February 9, 1982, G.U. 87 of Mar. 30, 1982, Approval and Implementation of the International Sanitary Regulations Adopted at Boston on July 25, 1969, Amended by the Additional Regulations Adopted in Geneva on May 23, 1973], G.U. No. 87, Mar. 3, 1982, http://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:legge:1982-02-09;[email protected].

[20] States Parties to the International Health Regulations (2005), World Health Organization, http://www.who.int/ihr/legal_issues/states_parties/en/.

[21] Circolare Ministeriale N° 0026708, Procedure operative per la gestione di casi sospetti, probabili o confermati e contatti di malattia da virus Ebola (MVE) in Africa Occidentale [Operational Procedures for the Management of Suspected, Probable, or Confirmed Cases and Contacts of the Ebola Virus Disease in Western Africa] (Circular) (Oct. 14, 2014), http://www.inmi.it/file/ebola/procedura_ebola_unita_crisi_rev2_16_10_2014.pdf.

[22] Id.

[23] Camera dei deputati, Session No. 228 (May 14, 2014), Misure sanitarie per tutelare i cittadini in relazione al flusso di immigrati provenienti dal Mediterraneo, con particolare riferimento alla diffusione di un’epidemia del virus ebola in varie aree dell’Africa [Sanitary Measures to Protect Citizens with Relation to the Influx of Immigrants Coming from the Mediterranean, with Particular Reference to the Dissemination of the Ebola Virus in Several Areas of Africa], http://banchedati.camera.it/sindacatoispettivo_17/showXhtml.asp?highLight=0&idAtto=18464&stile=7; XVII Legislatura, Resoconto stenografico dell’Assemblea Seduta n. 228 di mercoledì 14 maggio 2014 [XVII Legislature, Transcript of Assembly Session No. 228, of May 14, 2014], http://www.camera.it/leg17/ 410?idSeduta=0228&tipo=stenografico#

[24] Id.  See also FAQ – Malattia da virus Ebola (EVD), Question 16, Qual è la situazione in Italia e quali misure sono state prese? [FAQ – What Is the Situation in Italy, and What Measures Have Been Taken?], Ministero della salute [Health Ministry], http://www.salute.gov.it/portale/p5_1_1.jsp?lingua=italiano&id=184 (last visited Nov. 7, 2014).

[25] FAQ, supra note 24.

[26] Id.

[27] Circular, supra note 21.

[28] Id.

[29] Id. at 9.

[30] Id.

[31] Id.

[32] Id. at 12.

[33] Id. at 14.

[34] Id.

[35] Id.

[36] Id. at 15.

[37] Id.

[38] Id. at 17.

[39] Id.

[40] Id. at 18.

[41] Id. at 25.

[42] Id.

[43] Eventi epidemici all’estero [Epidemic Events Overseas], Ministero della Salute, http://www.salute.gov.it/ portale/news/p3_2_1_3_4.jsp?lingua=italiano&menu=notizie&p=avvisi&%20tipo=eventiEpidemici (last visited Nov. 7, 2014).

[44] Lazio Region, Epidemia da virus Ebola in Africa Occidentale: indicazioni per la sorveglianza e il controllo. Protocollo regionale, http://www.regione.lazio.it/binary/rl_main/tbl_news/Protocollo_Ebola.pdf.

[45] Id. at 3.

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Last Updated: 06/09/2015