The European Union (EU) Member States are mainly individually responsible for responding to public health and other major emergencies within their borders. The EU’s role in the field of public health, as established by the Treaty on the Functioning of the EU, is limited to complimenting the national policies of the EU Members, coordinating their actions, and facilitating communication and the exchange of data between the European Commission and the EU Members.
The most recent health crises in the EU acted as a catalyst for the Commission to reform the 1998 EU legislation. A new decision, Decision No. 1082/2013, expands the type of serious health threats with cross-border implications to also include threats of chemical, environmental, or unknown origin. Events that may constitute public health emergencies of international concern have been added to the list, in compliance with the 2005 revised WHO International Health Regulations, to which EU Members are bound. The Health Security Committee, which acquired formal status by Decision No. 1082/2013, assists the Commission in coordinating public health crises; it also advises the ministers on health of the EU Members and coordinates their actions. In implementing Decision No. 1082/2013, the EU Members have designated national authorities in charge of epidemiological surveillance, alert notification, and taking measures to protect public health.
The European Centre for Disease Prevention and Control (ECDC) plays a vital role in the surveillance, identification, assessment, and communication of current and/or emerging threats to human health. The ECDC has assumed operation of the Epidemiological Surveillance Network and the Early Warning and Response System, both of which were established in 1998 to enhance the EU’s ability to respond to public health emergencies.
The European Union (EU), due to its specific nature as an area with no internal borders and the free circulation of people and goods, faces special challenges in the event of public health crises. Primary responsibility for responding to public health emergencies falls within the domain of the EU Member States. The EU has legal authority in the field of public health based on article 168 of the Treaty on the Functioning of the European Union. In general, EU action in the field of public health is intended to complement the national policies of the EU Members and to coordinate and support their actions. In this regard, the Commission plays a vital role, both in coordinating and exchanging information between the EU Member States and in maintaining the structures and mechanisms that operate at the EU level to address public health crises. In addition to twenty-eight EU Members, three non-EU Member countries that participate in the EU Single Market, Iceland, Lichtenstein, and Norway, also cooperate with the Commission in matters involving public health.
At the EU level, several agencies are engaged in preparedness and response planning to combat serious threats to health. The European Centre for Disease Prevention and Control (ECDC), which was established in 2005 and was modeled after the US Centers for Disease Control and Prevention, plays a pivotal role in the field of communicable diseases and other public health crises. Other agencies involved at the EU level include the European Food Safety Authority (EFSA), the European Medicines Agency (EMEA), and the European Environment Agency (EEA). In addition, the European Commission’s Health Security Committee, which was established in the aftermath of the September 11, 2001, terrorist attacks on the US (9/11 attacks), acquired formal status by new EU legislation and has been given a specific mandate. The EU has also established two committees to assist the Commission when a scientific opinion is needed: (a) the Scientific Committee on Emerging and Newly Identified Health Risks, and (b) the Scientific Committee on Health and Environmental Risks.
Past experience with public health crises in the EU have clearly demonstrated that such crises affect numerous sectors, including health, food safety, environment, transport, and national security. Thus, the Commission in 2011 initiated new legislation to address the existing deficiencies in tackling health crises. A new decision, Decision No. 1082/2013 on Serious Cross-Border Threats to Health, expands the list of sources of danger to health to include not only communicable diseases but also biological, chemical, and environmental events, or events of unknown origin that may pose a risk to EU citizens.
At the international level, the Commission is engaged in promoting and improving collaborations on global public health issues by participating in the Global Health Security Initiative (GHSI), an international partnership launched in 2001 by the Commission, G7 countries (Canada, France, Germany, Italy, Japan, the United Kingdom, and the United States), and Mexico. Moreover, the Commission, the ECDC and other agencies have established solid cooperation with the World Health Organization (WHO) through its regional office in Europe (WHO/Europe).
II. Recent Legislation on Serious Public Health Crises
Article 2 of Decision No. 1082/2013/EU on Serious Cross-Border Threats to Health, issued in 2013, recognizes the following categories of serious cross-border threats to health, which may trigger public health measures:
- (a) threats of a biological origin, consisting of:
- (i) communicable diseases;
- (ii) antimicrobial resistance and healthcare-associated infections related to communicable diseases . . .;
- (iii) biotoxins or the other harmful biological agents not related to communicable diseases;
- (b) threats of chemical origin;
- (c) threats of environmental origin;
- (d) threats of unknown origin;
- (e) events which may constitute public health emergencies of international concern under the IHR, provided that they fall under one of the categories of threats set out in points (a) to (d).
Decision No. 1082/2013 introduced the possibility of joint procurement of medical countermeasures, such as vaccines, which could be done through a Joint Procurement Agreement between the EU institutions and those EU Members who wish to participate.
EU Members have the right to maintain or introduce additional measures and procedures to tackle serious threats to health due to biological, chemical, environmental, or unknown origin within their borders. In compliance with Decision No. 1082/2013, EU Members have designated the appropriate competent authorities responsible for epidemiological surveillance,for alert notifications, and for taking the necessary measures to protect public health in times of crisis. The Commission has prepared a template for the national authorities to be used to provide information on preparedness and response planning regarding cross-border threats to health.
III. Overview of Systems Responsible for Crises Management at the EU Level
The various health crises that the EU has encountered thus far, such as mad cow disease, the SARS and flu epidemics, and the ash cloud caused by the eruption of a volcano in Iceland, have demonstrated the need for cross-sector preparedness, monitoring, and response in order to tackle such crises effectively. Therefore, beginning in 1998, the EU established the following critical organizations and systems with the objective of enhancing its own ability and that of its Members to respond to public health emergencies more efficiently.
A. Epidemiological Surveillance Network
Decision No. 1082/2013 extended the scope of the network for the epidemiological surveillance of communicable diseases that was initially established in 1998 to include all the additional sources of threats to public health contained in article 2 (quoted above). This network is operated and coordinated through the ECDC. The national authorities are required to send all authorities connected through the network certain data, including comparable and compatible data related to the communicable diseases and other threats to public health contained in article 2; updates on the development of epidemic situations; and information on unusual epidemics or new communicable diseases of unknown origin, including those that occur outside the EU.
B. Early Warning and Response System
At the EU level, an Early Warning and Response System (EWRS) was established in 1998, to be used to notify alerts relating to serious cross-border threats to health. Based on this system, the Commission and the national authorities are constantly communicating regarding alerts, assessing public health risks, and deciding on appropriate measures.
Alert notifications are sent either by the Commission or the national authorities to the EWRS when a serious cross-border threat is unusual or unexpected for the specific place where it originated and has the potential to lead to significant morbidity and mortality in humans (or grows larger), affects more than one Member State, and may require a coordinated response at the Union level.
C. European Centre for Disease Prevention and Control
The ECDC is an independent agency, located in Stockholm, Sweden, whose chief mission is to “identify, assess and communicate current and emerging threats to human health from communicable diseases.” Specifically, the ECDC has the following tasks:
- Search for, collect, and disseminate scientific and technical data;
- Provide scientific opinions and scientific and technical assistance;
- Provide information promptly to the Commission, Member States, and Community agencies as well as international organizations involved in public health issues;
- Coordinate the actions of the EU networks dealing with public health issues together with those networks or contact points designated by the national authorities, the so-called “dedicated surveillance networks;” and
- Exchange information and expertise, and facilitate the implementation of joint actions.
Since it began its functions in 2005, the ECDC has assumed responsibility for the operation of the Epidemiological Surveillance Network at the Union level and the EWRS, both of which were established in 1998. Since ECDC was established, EU Members have been required to forward to the ECDC any information sent through the EWRS, provide the ECDC with timely scientific and technical data to enable it to perform its mission, and identify competent bodies and experts in public health who could be available to assist the EU in case of disease clusters or outbreaks.
D. Health Security Committee
Decision No. 1082/2013 granted formal status to the Health Security Committee (HSC), which was first established as an informal forum of discussion of public threats in the aftermath of the 9/11 attacks. The HSC is composed of representatives of the EU Members through their designated person and is chaired by a person appointed by the Commission. The HSC is tasked with (a) supporting the exchange of information between the Commission and the EU Members on practices regarding implementation of Decision No. 1082/2013; and (b) coordinating jointly with the Commission preparedness and response planning, as put together by the EU Members.
IV. Privacy Concerns
Since public health crises often involve the handling and processing of personal data of individuals, EU Members and the Commission are required to comply with EU legislation on the protection of privacy and personal data, as provided for in Directive 95/46/EC, which has been implemented by the EU Members, and Regulation (EC) No. 45/2001 on the Protection of Individuals with Regard to the Processing of Personal Data by the Community Institutions and Bodies and on the Free Movement of Such Data.
In compliance with the EU legislation, which requires that personal data must be collected only for a specific purpose and must be eliminated afterwards, Decision No. 1082/2013 provides that the EWRS system must include a “selective messaging functionality” under which personal data of individuals must be communicated only to national competent authorities responsible for tracing measures. The national authorities will forward such data only to the other EU Members that are involved in the contact tracing measures.
Any messages that contain personal data can be kept for twelve months and after that period must be automatically erased from the EWRS selective messaging functionality. Decision No. 1082/2013 deems the national competent authorities in charge of preparedness and monitoring public health care crises and the Commission as “controllers” as defined by EU legislation on privacy. Controllers are either natural or legal persons or public authorities that determine the purposes and means for processing personal data. Therefore, they are required to take technical and organizational measures to protect personal data against unauthorized access, accidental loss, or illegal destruction.
V. WHO International Health Regulations and the EU
The collaboration of the EU and the World Health Organization (WHO) is based on article 168 of the Treaty on the Functioning of the EU, which requires the EU and Member States to foster cooperation with international organizations competent in the field of public health. The Commission and the WHO cooperate by exchanging information and sharing experience in assessing health risks, strengthening communicable disease surveillance and improving responses, and developing tools for health monitoring. The ECDC also collaborates closely with the WHO.
In 2005, the WHO revised its International Health Regulations (IHR). The IHR, as an international legal instrument, is legally binding on all states parties, including the twenty-eight EU Members. The revised IHR introduced the concept of public health emergencies of international concern in order to cover existing, new, and old diseases, including health crises due to noninfectious diseases. It entered into force on June 15, 2007, and requires WHO members to implement the regulations gradually by 2016. The EU itself is not a WHO member, and therefore is not a party to the IHR. However, article 57(3) of the IHR recognizes the role of the EU as a “regional economic integration organization” and states that, “[w]ithout prejudice to their obligations under these Regulations, States Parties that are members of a regional economic integration organization shall apply in their mutual relations the common rules in force in that regional economic integration organization.”
In a 2006 Communication on the IHR, the Commission articulated the role that the ECDC and the EWRS can play in implementing the IHR more effectively and coherently in case of public health crises of international concern. In general, preparation and planning for health crises at the EU level follows the general recommendations of the WHO, adapted to particular situations in Europe. If a health emergency, such as pandemic influenza, erupts outside of the EU, the WHO is the organization that identifies the level of emergency and preparedness. The European Commission also has the authority to recognize a pandemic independently of the WHO, based on Decision No. 1082/2013, elaborated above.
VI. Ebola Outbreak
The current Ebola outbreak in West Africa, like the recent polio outbreak in the EU, set in motion the agencies and networks involved in handling such crises, even though, according to EU estimates, the risk of Ebola for EU citizens was low. The European Commission is closely working with the EU Member States within the Health Security Committee to keep them informed about the latest developments and to coordinate approaches on prevention and preparation for Ebola. The Commission’s Health and Consumers Directorate-General has been closely monitoring the event in cooperation with the ECDC and the WHO since March 2014, when news of the outbreak first appeared. The ECDC is producing risk assessments, epidemiological updates, and other information. The risk of importation to the EU is considered very low, in particular if returning travelers and health care providers are properly informed and are aware of the risk. Only a few EU health care workers have been infected and have returned to the EU for medical care.
The European Food Safety Agency played an active role in monitoring the Ebola epidemics due to reports of a potential link between Ebola virus found in bushmeat, coming from wild animals native to African forests, and possible transmission to humans. The EFSA experts concluded that the risk from bushmeat consumption and possible infection with Ebola virus is low. Meanwhile, however, the EU has prohibited the import of bushmeat into the EU.
From the outset of the Ebola crisis, the European Commission has been active with humanitarian aid, expertise, and international coordination. In addition, diplomatic outreach is being done via the Delegations of the EU and other channels in order to facilitate the humanitarian response in the countries concerned and to sensitize governments not to overreact to the crisis with regard to travel restrictions, trade impediments, etc.
As early as March 2014 the European Commission gave €1.9 million (about US$2.4 million) to help contain the Ebola epidemics and to ensure immediate health care for the affected populations. Since then, the Commission has boosted its humanitarian assistance on two occasions, bringing it to a current total of €11.9 million (about US$14.84 million). On September 5, 2014, the European Commission announced €140 million of funding (about US$175 million) for the countries affected by the Ebola virus in West Africa: Guinea, Sierra Leone, Liberia, and Nigeria.
Prepared by Theresa Papademetriou
Senior Foreign Law Specialist
 Consolidated Version of the Treaty on the Functioning of the European Union (TFEU) art. 168, 2012 O.J. (C 326) 47, http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:12012E/TXT.
 Outbreak of Ebola Virus Disease in Western Africa, European Commission, Directorate-General for Health and Consumers (Oct. 28, 2014; updated Nov. 12, 2014), http://ec.europa.eu/health/ebola/index_en.htm.
 The European Economic Area (EEC) agreement, which entered into force in January 1994, permits three of the European Free Trade Association (EFTA) countries (Iceland, Norway, and Liechtenstein) to participate in the EU single market. European Economic Area, European Union External Action, http://eeas.europa.eu/eea/ index_en.htm (last visited Nov. 12, 2014).
 The ECDC was established by Regulation (EC) No. 851/2004 of the European Parliament and of the Council of 21 April 2004 Establishing a European Centre for Disease Prevention and Control, 2004 O.J. (L 142) 1, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004R0851:EN:HTML.
 In the aftermath of the food crisis in the 1990s, especially the Bovine Spongiform Encephalopathy (BSE) or “mad cow disease” outbreak and dioxin contamination, the EU in 2002 established the EFSA, comprised of European experts who provide risk assessment and risk communication on issues involving food safety. See Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002, Laying Down the General Principles and Requirements of Food Law, Establishing the European Food Safety Authority and Laying Down Procedures in Matters of Food Safety, 2002 O.J. (L 31) 1, http://eur-lex.europa.eu/LexUriServ/LexUriServ. do?uri=OJ:L:2002:031:0001:0024:EN:PDF.
 The EMEA is based in London, and is responsible for the authorization and marketing of medicinal products for human and veterinary use. See About EMEA –Structure, (last visited Nov. 22, 2014) The EMEA was established by Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 Laying Down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency, 2004 O.J. (L 136) 1, http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2004:136:0001:0033:en:PDF.
 The EEA began operations in 1994 and assists EU institutions and Member States on environmental issues. Council Regulation (EEC) No. 1210/90 of 7 May 1990 on the Establishment of the European Environment Agency and the European Environment Information and Observation Network, 1990 O.J. (L 120) 1, http://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri=CELEX:31990R1210:EN:HTML.
 The Scientific Committee on Emerging and Newly Identified Health Risks and the Scientific Committee on Health and Environmental Risks were established by Commission Decision 2008/721/EC Setting Up an Advisory Structure of Scientific Committees and Experts in the Field of Consumer Safety, Public Health and the Environment and Repealing Decision 2004/210/EC, 2008 (L 241) 21, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri= OJ:L:2008:241:0021:0030:EN:PDF.
 Press Release, European Commission, Q&A: Health Security in the EU (Dec. 8, 2011), http://europa.eu/ rapid/press-release_MEMO-11-884_en.htm.
 Decision No. 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on Serious Cross-border Threats to Health and Repealing Decision No. 2119/98/EC, 2013 O.J. (L 293) 1, http://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:293:0001:0015:EN:PDF.
 Commission Staff Working Document, Health Security in the European Union and Internationally, SEC (2009) 1622 final, at 3 (Nov. 23, 2009), http://ec.europa.eu/health/preparedness_response /docs/commission_staff_ healthsecurity_en.pdf.
 Decision No. 1082/2013/EU, supra note 11, art. 2, para. 1.
 Id. art. 2, para. 4.
 Id. art. 5.
 Id. art. 2, para. 6.
 Id. art. 15, para. 1(a) & (b).
 Commission Implementing Decision 2014/504/EU of 25 July 2014 Implementing Decision No. 1082/2013/EU of the European Parliament and of the Council with Regard to the Template for Providing the Information on Preparedness and Response Planning in Relation to Serious Cross-border Threats to Health (Notified Under Document C(2014) 5180) Text with EEA Relevance, 2014 O.J. (L 223) 25, http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.223.01.0025.01.ENG.
 Id. art. 6, para. 1.
 Id. art. 6, para. 3.
 Id. art. 8, para. 1.
 Id. art. 9, para. 1(a)–(c).
 Regulation (EC) No. 851/2004, supra note 5, art. 3, para. 1.
 Id. art. 3, para. 2.
 Decision No. 1082/2013, supra note 11, art 17, para. 1.
 Regulation (EC) No. 851/2004, supra note 5, art. 4.
 Decision No. 1082/2013, supra note 11, art. 17, para. 1.
 Id. art. 17, para. 3.
 Id. art. 17, para. 2.
 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data, 1995 O.J. (L 281) 31, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:en:HTML.
 Regulation (EC) No. 45/2001 of the European Parliament and of the Council of 18 December 2000 on the Protection of Individuals with Regard to the Processing of Personal Data by the Community Institutions and Bodies and on the Free Movement of Such Data, 2001 O.J. (L 8) 1, http://eur-lex.europa.eu/legal-content/EN/TXT/? uri=celex:32001R0045.
 Decision No. 1082/2013, supra note 11, art. 16, para. 2.
 Id. art. 16, para. 3.
 Id. art. 16, para. 4.
 Directive 95/46/EC, supra note 32, art. 2(d).
 Id. art. 16, para. 1.
 TFEU, supra note 1, art. 168, para. 3.
 In 2001, the European Commission and the WHO signed a Memorandum of Understanding to further develop and reinforce their mutual cooperation, and the WHO has also established an office in Brussels. Exchange of Letters Between the WHO and the Commission of the European Communities Concerning the Consolidation and Intensification of Cooperation – Memorandum Concerning the Framework and Arrangements for Cooperation Between the WHO and the Commission of the European Communities, 2001 O.J. (C 001) 7 (Jan. 4, 2001), http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=22001 A0104(01)&model=guichett.
 EU in the World, Public Health, WHO, http://ec.europa.eu/health/eu_world/ international_organisations/who/ index_en.htm (last visited Oct. 24, 2014).
 WHO, International Health Regulations (2d ed. 2005), http://www.who.int/ihr/publications/97892415 96664/en/.
 Id. art. 57, para. 3.
 Communication from the Commission to the European Parliament and to the Council, on the International Health Regulations, COM (2006) 552 final (Sept. 26, 2006), http://ec.europa.eu/health/ph_international/ documents / comm_ihr_552_2006_en.pdf.
 Decision No. 1082/2003, supra note 11, art. 12.
 See ECDC, Technical Report, Detection and Control of Poliovirus Transmission in the European Union and European Economic Area (Feb. 2014), http://www.ecdc.europa.eu/en/publications/Publications/polio-detection-control-EU.pdf.
 Press Release, European Commission, Memo, The EU’s Response to Help Fight the Ebola Outbreak in West Africa (Sept. 5, 2014), http://europa.eu/rapid/press-release_MEMO-14-520_en.htm.
 Outbreak of Ebola Virus Disease in Western Africa, European Commission, Directorate-General for Health and Consumers (Oct. 28, 2014; updated Nov. 12, 2014), http://ec.europa.eu/health/ebola/index_en.htm.
 EFSA Assesses the Risk of Transmission of Ebola Through Bushmeat, European Food Safety Authority (Nov. 4, 2014), http://www.efsa.europa.eu/en/press/news/141104a.htm?utm_source=feed&utm_medium= rss&utm_campaign=comb.
 Press Release, European Commission, supra note 47.
Last Updated: 06/09/2015