Early Warning and Response System
1. The EWRS shall enable the Commission, the ECDC, and the competent authorities responsible at national level to be in permanent communication for the purposes of preparedness, early warning and response, alert notifications, assessing public health risks and determining the measures that may be required to protect public health.
2. The management and operational use of the EWRS shall involve the exchange of personal data in specific cases where the relevant legal instruments so provide. Such management and use shall include:
(a)
the processing of personal data of authorised users of the system; and
(b)
the processing of health data and other personal data when strictly necessary for the purpose for which those data were transmitted, through the EWRS selective messaging functionality, in accordance with Article 28.
Taking into account Member States’ opinions, the ECDC shall continuously update the EWRS, allowing for the use of modern technologies such as digital mobile applications, artificial intelligence models, space-enabled applications, or other technologies for automated contact tracing, building upon the contact-tracing technologies developed by the Member States or by the Union and used for the purpose of combatting serious cross-border threats to health. The ECDC, in close cooperation with Member States, shall facilitate interoperability with national systems for the purposes of the EWRS.
The ECDC shall also provide technical assistance to the competent authorities responsible at national level, including training following updates to the EWRS.
3. Each Member State shall designate the competent authority or authorities responsible at national level for notifying alerts and determining the measures required to protect public health, for the purposes of early warning and response in accordance with paragraphs 1 and 2 of this Article, as well as Articles 19 and 20.
4. The Commission shall, by means of implementing acts, adopt procedures concerning the information exchange with other rapid alert systems at Union and international levels, including exchange of personal data, in order to ensure the proper functioning of the EWRS and to avoid the overlapping of activities or conflicting actions with existing structures and mechanisms for preparedness for, monitoring, early warning of and combatting serious cross-border threats to health, in a coordinated One Health approach.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
Alert notification
1. National competent authorities or the Commission shall notify an alert in the EWRS, where the emergence or development of a serious cross-border threat to health fulfils the following criteria:
(a)
it is unusual or unexpected for the given place and time, it is causing or may cause significant morbidity or mortality in humans, it is growing rapidly or may grow rapidly in scale, or it is exceeding or may exceed national response capacity;
(b)
it affects or may affect more than one Member State; and
(c)
it requires or may require a coordinated response at Union level.
2. Where the national competent authorities notify the WHO of events that may constitute public health emergencies of international concern, and in the absence of full interoperability between the WHO notification system and the EWRS, national competent authorities shall simultaneously notify an alert in the EWRS, provided that the threat concerned falls within those referred to in Article 2(1) of this Regulation.
3. When notifying an alert, the national competent authorities and the Commission shall promptly communicate through the EWRS any available relevant information in their possession that may be useful for coordinating the response such as:
(a)
the type and origin of the agent;
(b)
the date and place of the incident or outbreak;
(c)
means of transmission or dissemination;
(d)
toxicological data;
(e)
detection and confirmation methods;
(f)
public health risks;
(g)
public health measures implemented or intended to be taken at national level;
(h)
measures other than public health measures, including multi-sectoral measures;
(i)
whether there is an urgent need for or shortage of medical countermeasures;
(j)
requests and offers for cross-border emergency assistance, such as the medical transfer of patients or provision of healthcare staff by one Member State to another, in particular in cross-border areas in neighbouring regions;
(k)
personal data necessary for the purpose of contact tracing in accordance with Article 28;
(l)
any other information relevant to the serious cross-border threat to health in question.
4. The Commission shall make available to the national competent authorities through the EWRS any information that may be useful for coordinating the response referred to in Article 21, including information relating to serious cross-border threats to health and public health measures related to serious cross-border threats to health, already transmitted through rapid alert and information systems established under other provisions of Union law or the Euratom Treaty.
5. Member States shall update the information referred to in paragraph 3 as new data become available.
Public health risk assessment
1. Where an alert is notified pursuant to Article 19, the Commission shall, where necessary for the coordination of the response at Union level referred to in Article 21 or at the request of the HSC or on its own initiative, make promptly available to the national competent authorities and to the HSC, through the EWRS, a risk assessment of the potential severity of the threat to public health, including possible public health measures. That risk assessment shall be carried out by one or more of the following Union agencies or bodies:
(a)
the ECDC, in accordance with Article 8a of Regulation (EC) No 851/2004, in the case of a serious cross-border threat to health referred to in Article 2(1), points (a)(i) and (a)(ii), including where it relates to substances of human origin that can potentially be impacted by communicable diseases, or in Article 2(1), point (d), of this Regulation;
(b)
the European Medicines Agency (EMA), in accordance with Article 1 of Regulation (EU) 2022/123 of the European Parliament and of the Council ( 37 ) , where the serious cross-border threat to health is linked to medicinal products and medical devices;
(c)
the European Food Safety Authority (EFSA), in accordance with Article 23 of Regulation (EC) No 178/2002 of the European Parliament and of the Council ( 38 ) , in the case of a serious cross-border threat to health referred to in Article 2 of this Regulation where that threat falls under the mandate of EFSA;
(d)
the European Chemicals Agency (ECHA), in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council ( 39 ) , in the case of a serious cross-border threat to health referred to in Article 2(1), point (b) or (c), of this Regulation where that threat falls under the mandate of the ECHA;
(e)
the European Environment Agency (EEA), in accordance with Regulation (EC) No 401/2009 of the European Parliament and of the Council ( 40 ) , in the case of a serious cross-border threat to health referred to in Article 2(1), point (c), of this Regulation, where that threat falls under the mandate of the EEA;
(f)
the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), in accordance with Regulation (EC) No 1920/2006 of the European Parliament and of the Council ( 41 ) , in the case of a serious cross-border threat to health referred to in Article 2(1), point (b), of this Regulation, where that threat falls under the mandate of the EMCDDA.
The risk assessment shall be carried out in the case of a threat referred to in Article 2(1) of this Regulation in cooperation with the European Union Agency for Law Enforcement Cooperation (Europol) where the serious cross-border threat to health emanates from terrorist or criminal activity referred to in Article 3 of Regulation (EU) 2016/794 of the European Parliament and of the Council ( 42 ) ; and in cooperation with EMA, where the serious cross-border threat to health is linked to medicinal products.
2. At the request of the Union agency or body carrying out the risk assessment within its mandate, the Union agencies and bodies referred to in paragraph 1 of this Article shall, without undue delay, provide any relevant information and data at their disposal. Processing of personal data, whenever applicable, shall be carried out in accordance with the data protection requirements as laid down in Article 27.
3. Where the risk assessment needed is totally or partially outside the mandates of the Union agencies and bodies referred to in paragraph 1, and is considered necessary for the coordination of the response at Union level, the Commission shall, at the request of the HSC or on its own initiative, provide an ad hoc risk assessment.
4. The Commission shall make risk assessments available to the national competent authorities promptly through the EWRS and to the HSC, and, if appropriate, through linked alert systems. Where the risk assessment is to be made public, the national competent authorities shall receive it 24 hours prior to its publication, unless the immediate publication of the risk assessment is required on grounds of urgency and necessity.
The risk assessment shall take into account, if available, relevant information provided by other entities, in particular by the WHO in the case of a public health emergency of international concern.
5. The Commission shall ensure that information that may be relevant for the risk assessment is made available to the national competent authorities through the EWRS and to the HSC.
Coordination of response within the HSC
1. Following an alert notification pursuant to Article 19, at the request of the Commission or of a Member State and on the basis of the available information, including the information referred to in Article 19 and the risk assessments referred to in Article 20, Member States shall consult each other and coordinate within the HSC and in liaison with the Commission with regard to the following:
(a)
national responses, including research needs, to the serious cross-border threat to health, including where a public health emergency of international concern is declared in accordance with the IHR and falls within Article 2 of this Regulation;
(b)
risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing consistent and coordinated information in the Union to the public, to healthcare professionals and public health professionals;
(c)
the adoption of opinions and guidance, including on specific response measures for the Member States for the prevention and control of a serious cross-border threat to health, based on the expert opinion of relevant technical Union agencies or bodies; and
(d)
support for the EU Integrated Political Crisis Response Arrangements (IPCR) as referred to in Council Decision 2014/415/EU ( 43 ) in the event of its activation.
2. Where a Member State intends to adopt or to terminate public health measures to combat a serious cross-border threat to health, it shall, before adopting or terminating those measures, inform, consult and coordinate with the other Member States, in particular neighbouring Member States, and the Commission on the nature, purpose and scope of those measures, unless the need to protect public health is so urgent that the immediate adoption of those measures is necessary.
3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, upon adoption, promptly inform the other Member States and the Commission of the nature, purpose and scope of those measures, especially in cross-border regions.
4. If necessary, in the event of a serious cross-border threat to health, Member States may request assistance from other Member States through the Emergency Response Coordination Centre (ERCC) provided for in Decision No 1313/2013/EU.
5. The Commission shall, by means of implementing acts, adopt the procedures necessary for the uniform implementation of the information exchange, consultation and coordination provided for in paragraphs 1, 2 and 3 of this Article.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
Recommendations on common temporary public health measures
1. The Commission may complement the action of the Member States through the adoption of recommendations on common temporary public health measures.
2. The recommendations on common temporary public health measures adopted under paragraph 1 shall:
(a)
be based on, in particular, recommendations of the ECDC and the WHO, other relevant Union agencies or bodies, or the Advisory Committee referred to in Article 24;
(b)
respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care;
(c)
be necessary, suitable and proportionate to the public health risks related to the serious cross-border threat to health in question, avoiding, in particular, any unnecessary restriction on the free movement of persons, of goods and of services, and promote coordination of measures between Member States; and
(d)
be made available to the national competent authorities promptly through the EWRS and to the HSC, and, if appropriate, through linked alert systems; where the recommendation is to be made public, the national competent authorities shall receive it 24 hours prior to its publication, unless the need is so urgent that the immediate publication of the recommendation is necessary.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
