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 Text with EEA relevance

Original version:<a href='/vid/decision-no1082-2013-eu-843257565'>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 Text with EEA relevance</a>



Official Journal of the European Union

L 293/1


of 22 October 2013

on serious cross-border threats to health and repealing Decision No 2119/98/EC

(Text with EEA relevance)


Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(5) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (2),



Article 168 of the Treaty on the Functioning of the European Union (TFEU) states, inter alia, that a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities. That Article further provides that Union action is to complement national policies, is to cover monitoring, early warning of, and combating serious cross-border threats to health, and that Member States are, in liaison with the Commission, to coordinate among themselves their policies and programmes in the areas covered by Union action in the field of public health.


Pursuant to Decision No 2119/98/EC of the European Parliament and of the Council (3) a network for the epidemiological surveillance and control of communicable diseases in the Community was set up. Experience gained in the implementation of that Decision confirms that coordinated Union action on monitoring, early warning of and combating those threats adds value to the protection and improvement of human health. However, a number of developments at Union and international level in the past decade have made a review of that legal framework necessary.


Apart from communicable diseases, a number of other sources of danger to health, in particular related to other biological or chemical agents or environmental events, which include hazards related to climate change, could by reason of their scale or severity, endanger the health of citizens in the entire Union, lead to the malfunctioning of critical sectors of society and the economy and jeopardise an individual Member State’s capacity to react. The legal framework set up under Decision No 2119/98/EC should, therefore, be extended to cover other threats and provide for a coordinated wider approach to health security at Union level.


An important role in the coordination of recent crises of Union relevance has been played by an informal group composed of high-level representatives from Member States, referred to as the Health Security Committee, and established on the basis of the Presidency Conclusions of 15 November 2001 on bioterrorism. It is necessary to give this group a formalised status and to assign it a well-defined role to avoid duplications with other Union entities responsible for risk management.


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 (4) (‘ECDC’) provides the ECDC with a mandate covering surveillance, detection and risk- assessment of threats to human health from communicable diseases and outbreaks of unknown origin. The ECDC has progressively taken over the epidemiological surveillance of communicable diseases and the operation of the Early Warning and Response System (‘EWRS’) from the Community network set up under Decision No 2119/98/EC. Those changes are not reflected in Decision No 2119/98/EC, because it was adopted before the establishment of the ECDC.


The International Health Regulations (2005) (‘IHR’) adopted by the Fifty-eighth World Health Assembly on 23 May 2005 reinforced the coordination among States Parties to the World Health Organisation (WHO), which include all the Member States of the Union, of the preparedness for, and response to, a public health emergency of international concern. Union legislation should take this development into account, including the integrated all-hazards approach of the WHO covering all categories of threat regardless of their origin.


This Decision should apply without prejudice to other binding measures concerning specific activities or setting the standards of quality and safety of certain goods, which provide for special obligations and tools for monitoring, early warning and combating specific threats of a cross-border nature. Those measures include in particular relevant Union legislation in the area of common safety concerns in public health matters, covering goods such as pharmaceutical products, medical devices and foodstuffs, and exposure to ionising radiation.


The protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States, should ensure coordination and exchange of information between the mechanisms and structures established under this Decision, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the activities of which are relevant to the preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. In particular the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the EWRS.


The structures for coordinating responses to serious cross-border health threats established by this Decision, should, in exceptional circumstances, be available to the Member States and the Commission also when the threat is not covered by this Decision and where it is possible that public health measures taken to counter that threat are insufficient to ensure a high level of protection of human health. The Member States should, in liaison with the Commission, coordinate the response within the Health Security Committee (‘HSC’) as established by this Decision in close cooperation with, where applicable, other structures, established at Union level and under the Euratom Treaty, for the monitoring, early warning or combating of such threats.


Preparedness and response planning is an essential element for effective monitoring, early warning of and combating serious cross-border threats to health. Such planning should include in particular adequate preparedness of critical sectors of society, such as energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning.


Cross-border threats to health are often related to pathogenic agents that can be transmitted between individuals. While such transmission cannot be completely prevented, general hygiene measures can make an important contribution by reducing the speed and extent of the spread of the agent and thus reducing the general risk. Such measures could include information on good hygiene practices, such as effective hand washing and drying, in collective settings and in the workplace, and should take into account the existing recommendations of the WHO.


The IHR already require Member States to develop, strengthen and maintain their capacity to detect, assess, notify and respond to a public health emergency of international concern. Consultation with a view to coordinating among the Member States is necessary in order to promote interoperability between national preparedness planning in view of the international standards, while respecting Member States’ competence to organise their health systems. Member States should regularly provide the Commission with an update on the status of their preparedness and response planning at national level. Information provided by the Member States should include the elements that Member States are obliged to report to the WHO in the context of the IHR. That information should particularly address the cross-border dimension of preparedness and response planning. The Commission should compile the information received and should ensure its exchange among Member States through the HSC. When a Member State decides to substantially revise its national preparedness planning, it should inform the Commission thereof and submit the information about the main aspects of that revision in a timely manner to the Commission to allow for information exchange and possible consultations within the HSC.


The European Parliament in its resolution of 8 March 2011 and the Council in its Conclusions of 13 September 2010 stressed the need to introduce a common procedure for the joint procurement of medical countermeasures, and in particular of pandemic vaccines, to allow Member States, on a voluntary basis, to benefit from such group purchases, e.g. by obtaining...

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