Subject matter
1. In order to address serious cross-border threats to health and the consequences thereof, this Regulation lays down rules on:
(a)
the Health Security Committee (HSC);
(b)
prevention, preparedness and response planning, including;
(i)
preparedness plans at Union and national levels; and
(ii)
reporting and assessing preparedness at national level;
(c)
joint procurement of medical countermeasures;
(d)
emergency research and innovation;
(e)
epidemiological surveillance and monitoring;
(f)
the network for epidemiological surveillance;
(g)
the Early Warning and Response System (EWRS);
(h)
risk assessment;
(i)
coordination of response; and
(j)
recognition of a public health emergency at Union level.
2. This Regulation establishes:
(a)
a network of EU reference laboratories for public health;
(b)
a network for substances of human origin; and
(c)
an advisory committee for the occurrence and recognition of a public health emergency at Union level.
3. In line with the One Health and Health in All Policies approaches, the implementation of this Regulation shall be supported by funding from relevant Union programmes and instruments.
Scope
1. This Regulation shall apply to public health measures in relation to the following categories of serious cross-border threats to health:
(a)
threats of biological origin, consisting of:
(i)
communicable diseases, including those of zoonotic origin;
(ii)
antimicrobial resistance and healthcare-associated infections related to communicable diseases (‘related special health issues’);
(iii)
biotoxins or other harmful biological agents not related to communicable diseases;
(b)
threats of chemical origin;
(c)
threats of environmental origin, including those due to the climate;
(d)
threats of unknown origin; and
(e)
events which may constitute public health emergencies of international concern under the International Health Regulations (IHR) (‘public health emergencies of international concern’), provided that they fall under one of the categories of threats set out in points (a) to (d).
2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues.
3. The provisions of this Regulation are without prejudice to provisions of other Union acts governing specific aspects of monitoring and early warning of serious cross-border threats to health, and the coordination of prevention, preparedness and response planning for, and the coordination of combatting, serious cross-border threats to health, including measures setting quality and safety standards for specific goods and measures concerning specific economic activities.
4. In exceptional emergency situations, a Member State or the Commission may request the coordination of response within the HSC as referred to in Article 21, for serious cross-border threats to health other than those referred to 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.
5. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the mechanisms and structures established under this Regulation and similar mechanisms and structures established at international level, Union level or under the Euratom Treaty, whose activities are relevant for prevention, preparedness and response planning for, monitoring, early warning of, and combatting serious cross-border threats to health.
6. 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 Regulation, 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 implementation of this Regulation.
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin, as referred to in Article 2(1), 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;
(2)
‘case definition’ means a set of commonly agreed diagnostic criteria that have to be fulfilled in order to accurately identify cases of a serious cross-border threat to health in a given population, while excluding the detection of unrelated threats;
(3)
‘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;
(4)
‘contact tracing’ means measures to identify persons who have been exposed to a source of a serious cross-border threat to health, and who are in danger of being infected or being infectious or who have developed a communicable disease, through manual or other technological means, with the sole objective of rapidly identifying potentially newly infected persons who may have come into contact with existing cases, in order to reduce further onward transmission;
(5)
‘epidemiological surveillance’ means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on communicable diseases and related special health issues;
(6)
‘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 on and analysis of specified indicators relating to serious cross-border threats to health;
(7)
‘One Health’ means a multi-sectoral approach which recognises that human health is connected to animal health and to the environment, and that actions to tackle threats to health must take into account those three dimensions;
(8)
‘Health in All Policies’ means an approach to the development, implementation and review of public policies, regardless of the sector, whereby the health implications of decisions are taken into account, and which seeks to achieve synergies and to avoid harmful health impacts being caused by such policies, in order to improve the health of the population and health equity;
(9)
‘public health measure’ means a decision or an action which is aimed at preventing, monitoring or controlling the spread of diseases or contamination, combatting severe risks to public health or mitigating their impact on public health;
(10)
‘medical countermeasures’ means medicinal products for human use as defined in Directive 2001/83/EC of the European Parliament and of the Council ( 27 ) , medical devices as defined in point 12 of this Article and other goods or services that are necessary for the purpose of preparedness for and response to serious cross-border threats to health;
(11)
'International Health Regulations' means the International Health Regulations (IHR) adopted by the World Health Organization (WHO) in 2005;
(12)
‘medical device’ means both a medical device as defined in Article 2, point (1), of Regulation (EU) 2017/745 of the European Parliament and of the Council ( 28 ) , read in conjunction with Article 1(2) and Article 1(6), point (a), of that Regulation, and an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746 of the European Parliament and of the Council ( 29 ) ;
(13)
‘health system capacity’ means the degree to which a health system maximizes its performance on the following six health system core components or building blocks: (i) service delivery, (ii) health workforce, (iii) health information systems, (iv) access to medical countermeasures, (v) financing, and (vi) leadership/governance; for the purposes of this Regulation, this definition applies only to the parts of health system components or building blocks affected by serious cross-border threats to health.
Health Security Committee
1. The HSC is hereby established. It shall be composed of representatives of the Member States at two working levels:
(a)
a senior level working group for regular discussions on serious cross-border threats to health and for the adoption of opinions and guidance as referred to in paragraph 3, point (d); and
(b)
technical working groups to discuss specific topics if necessary.
2. Representatives of relevant Union agencies and bodies may participate in HSC meetings as observers.
3. The HSC shall have the following tasks in cooperation with relevant participating Union agencies and bodies:
(a)
enabling coordinated action by the Commission and the Member States for the implementation of this Regulation;
(b)
coordinating in liaison with the Commission prevention, preparedness and response planning in accordance with Article 10;
(c)
coordinating in liaison with the Commission the risk and crisis communication and responses of the Member States to serious cross-border threats to health, in accordance with Article 21;
(d)
adopting opinions and guidance, including on specific response measures, for the Member States for the prevention and control of serious cross-border threats to health, based on the expert opinion of relevant technical Union agencies or bodies; and
(e)
adopting, on an annual basis, a work programme setting its priorities and objectives.
4. As far as possible, the HSC shall adopt its guidance and opinions by consensus.
In the event of a vote, the outcome of the vote shall be decided by a two-thirds majority of its members.
The members that have voted against or abstained shall have the right to have a document summarising the reasons for their position annexed to the guidance or opinions.
5. The HSC shall be chaired by a representative of the Commission without the right to vote. The HSC shall meet at regular intervals and whenever the situation requires, at the request of the Commission or a Member State.
6. The secretariat of the HSC shall be provided by the Commission.
7. The HSC and the Commission shall ensure regular consultation with public health experts, international organisations and stakeholders, including healthcare professionals, depending on the sensitivity of the subject.
8. The HSC shall adopt, by a two-thirds majority of its members, its rules of procedure. Those rules of procedure shall establish working arrangements, in particular with regard to:
(a)
the procedures for plenary meetings;
(b)
the participation of experts in plenary meetings, the status of possible observers, including from the European Parliament, Union agencies and bodies, third countries and the WHO; and
(c)
the examination by the HSC of the relevance to its mandate of a matter submitted to it and the possibility of recommending referral of that matter to a body competent under a provision of another act of the Union or under the Euratom Treaty.
The working arrangements relating to the first subparagraph, point (c), shall not affect the obligations of the Member States under Articles 10 and 21 of this Regulation.
9. Member States shall designate one representative and not more than two alternate members of the HSC.
Member States shall notify the Commission and other Member States of the designations referred to in the first subparagraph and of any change thereto. In the event of such a change, the Commission shall make available to the HSC’s members an updated list of such designations.
10. The European Parliament shall designate a technical representative to participate in the HSC as an observer.
11. The list setting out the authorities, organisations or bodies to which the HSC participants belong shall be published on the Commission's website.
12. The rules of procedure, guidance, agendas and minutes of the meetings of the HSC shall be published on the Commission's website unless such publication undermines the protection of a public or private interest, as defined in Article 4 of Regulation (EC) No 1049/2001.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
