CHAPTER I

This Decision lays down rules on epidemiological surveillance, monitoring, early warning of, and combating serious cross-border threats to health, including preparedness and response planning related to those activities, in order to coordinate and complement national policies. This Decision aims to support cooperation and coordination between the Member States in order to improve the prevention and control of the spread of severe human diseases across the borders of the Member States, and to combat other serious cross-border threats to health in order to contribute to a high level of public health protection in the Union. This Decision also clarifies the methods of cooperation and coordination between the various actors at Union level. This Decision shall apply to public health measures in relation to the following categories of serious cross-border threats to health: threats of biological origin, consisting of: communicable diseases; antimicrobial resistance and healthcare-associated infections related to communicable diseases (hereinafter ‘related special health issues’); biotoxins or other harmful biological agents not related to communicable diseases; threats of chemical origin; threats of environmental origin; threats of unknown origin; 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). This Decision shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues. The provisions of this Decision are without prejudice to provisions of other Union acts governing specific aspects of monitoring, early warning of, the coordination of preparedness and response planning for, and the coordination of, combating serious cross- border threats to health, including measures setting quality and safety standards for specific goods and measures concerning specific economic activities. In exceptional emergency situations, a Member State or the Commission may request response coordination within the HSC, as referred to in Article 11, for serious cross-border threats to health other than those covered in Article 2(1), if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the mechanisms and structures established under this Decision and similar mechanisms and structures established at Union level or under the Euratom Treaty whose activities are relevant for preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. Member States shall retain the right to maintain or introduce additional arrangements, procedures and measures for their national systems in the fields covered by this Decision, including arrangements provided for in existing or future bilateral or multilateral agreements or conventions, on condition that such additional arrangements, procedures and measures do not impair the application of this Decision. For the purposes of this Decision, the following definitions shall apply: ‘case definition’ means a set of commonly agreed diagnostic criteria that have to be fulfilled in order to accurately identify cases of a targeted serious cross-border threat to health in a given population, while excluding the detection of unrelated threats; ‘communicable disease’ means an infectious disease caused by a contagious agent which is transmitted from person to person by direct contact with an infected individual or by indirect means such as exposure to a vector, animal, fomite, product or environment, or exchange of fluid, which is contaminated with the contagious agent; ‘contact tracing’ means measures implemented in order to trace persons who have been exposed to a source of a serious cross-border threat to health, and who are in danger of developing or have developed a disease; ‘epidemiological surveillance’ means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on communicable diseases and related special health issues; ‘monitoring’ means the continuous observation, detection or review of changes in a condition, in a situation, or in activities, including a continuous function that uses systematic collection of data and analysis on specified indicators relating to serious cross-border threats to health; ‘public health measure’ means a decision or an action which is aimed at preventing, monitoring or controlling the spread of diseases or contamination, combating severe risks to public health or mitigating their impact on public health; ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.