Legal provisions of COM(2011)866 - Serious cross-border threats to health

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dossier COM(2011)866 - Serious cross-border threats to health.
document COM(2011)866 EN
date October 22, 2013

Contents

CHAPTER I - GENERAL PROVISIONS

Article 1 - Subject matter

1. 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.

2. 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.

3. This Decision also clarifies the methods of cooperation and coordination between the various actors at Union level.

Article 2 - Scope

1. This Decision 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;

(ii)antimicrobial resistance and healthcare-associated infections related to communicable diseases (hereinafter ‘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;

(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).

2. This Decision shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues.

3. 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.

4. 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.

5. 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.

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 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.

Article 3 - Definitions

For the purposes of this Decision, the following definitions shall apply:

(a)‘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;

(b)‘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;

(c)‘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;

(d)‘epidemiological surveillance’ means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on communicable diseases and related special health issues;

(e)‘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;

(f)‘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;

(g)‘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.

CHAPTER II - PLANNING

Article 4 - Preparedness and response planning

1. Member States and the Commission shall consult each other within the HSC referred to in Article 17 with a view to coordinating their efforts to develop, strengthen and maintain their capacities for the monitoring, early warning and assessment of, and response to, serious cross-border threats to health. That consultation shall be aimed at:

(a)sharing best practice and experience in preparedness and response planning;

(b)promoting the interoperability of national preparedness planning;

(c)addressing the intersectoral dimension of preparedness and response planning at Union level; and

(d)supporting the implementation of core capacity requirements for surveillance and response as referred to in Articles 5 and 13 of the IHR.

2. For the purpose of paragraph 1, Member States shall by 7 November 2014 and every three years thereafter provide the Commission with an update on the latest situation with regard to their preparedness and response planning at national level.

That information shall cover the following:

(a)identification of, and update on the status of the implementation of, the core capacity standards for preparedness and response planning as determined at national level for the health sector, as provided to the WHO in accordance with IHR;

(b)description of the measures or arrangements aimed at ensuring interoperability between the health sector and other sectors including the veterinary sector, that are identified as being critical in the case of an emergency, in particular:

(i)coordination structures in place for cross-sectoral incidents;

(ii)emergency operational centres (crisis centres);

(c)description of the business continuity plans, measures or arrangements aimed at ensuring the continuous delivery of critical services and products.

The obligation to provide the information referred to in points (b) and (c) shall only apply if such measures or arrangements are in place or are provided for as part of national preparedness and response planning.

3. For the purpose of paragraph 1, when substantially revising national preparedness planning, Member States shall inform the Commission in a timely manner of the main aspects of the revision of their preparedness planning at national level that are relevant to the objectives referred to in paragraph 1 and to the specific issues referred to in paragraph 2.

4. When receiving classified information transmitted pursuant to paragraphs 2 and 3 of this Article, the Commission and the HSC shall apply the rules set out in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom of 29 November 2001 amending its internal Rules of Procedure (12).

Each Member State shall ensure that its national security regulations apply to all natural persons resident on its territory and all legal persons established on its territory that handle the information referred to in paragraphs 2 and 3 of this Article. Those national security regulations shall offer a degree of protection of classified information at least equivalent to that provided by the rules on security as set out in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom and by Council Decision 2011/292/EU of 31 March 2011 on the security rules for protecting EU classified information (13).

5. The Commission shall make the information received in accordance with paragraphs 2 and 3 available to the members of the HSC.

On the basis of that information, and for the purpose of paragraph 1, the Commission shall, in a timely manner, initiate discussion in the HSC, including, where appropriate, on the basis of synthesis or thematic progress reports.

6. The Commission shall, by means of implementing acts, adopt templates to be used by the Member States when providing the information referred to in paragraphs 2 and 3 in order to ensure its relevance to the objectives identified in paragraph 1 and its comparability.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).

Article 5 - Joint procurement of medical countermeasures

1. The institutions of the Union and any Member States which so desire may engage in a joint procurement procedure conducted pursuant to the third subparagraph of Article 104(1) of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union (14) and pursuant to Article 133 of Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council on the financial rules applicable to the general budget of the Union (15), with a view to the advance purchase of medical countermeasures for serious cross-border threats to health.

2. The joint procurement procedure referred to in paragraph 1 shall comply with the following conditions:

(a)participation in the joint procurement procedure is open to all Member States until the launch of the procedure;

(b)the rights and obligations of Member States not participating in the joint procurement are respected, in particular those relating to the protection and improvement of human health;

(c)the joint procurement does not affect the internal market, does not constitute discrimination or a restriction of trade or does not cause distortion of competition;

(d)the joint procurement does not have any direct financial impact on the budget of Member States not participating in the joint procurement.

3. The joint procurement procedure referred to in paragraph 1 shall be preceded by a Joint Procurement Agreement between the Parties determining the practical arrangements governing that procedure, and the decision-making process with regard to the choice of the procedure, the assessment of the tenders and the award of the contract.

CHAPTER III - EPIDEMIOLOGICAL SURVEILLANCE AND AD HOC MONITORING

Article 6 - Epidemiological surveillance

1. A network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1), is hereby established. The network shall be operated and coordinated by the ECDC.

2. The epidemiological surveillance network shall bring into permanent communication the Commission, the ECDC, and the competent authorities responsible at national level for epidemiological surveillance.

3. The national competent authorities referred to in paragraph 2 shall communicate the following information to the participating authorities of the epidemiological surveillance network:

(a)comparable and compatible data and information in relation to the epidemiological surveillance of communicable diseases and related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1);

(b)relevant information concerning the progression of epidemic situations;

(c)relevant information concerning unusual epidemic phenomena or new communicable diseases of unknown origin, including those in third countries.

4. When reporting information on epidemiological surveillance, the national competent authorities shall, where available, use the case definitions adopted in accordance with paragraph 5 for each communicable disease and related special health issue referred to in paragraph 1.

5. The Commission shall, by means of implementing acts, establish and update:

(a)the list of communicable diseases and related special health issues established according to the criteria set out in the Annex and referred to in points (i) and (ii) of point (a) of Article 2(1), in order to ensure coverage of communicable diseases and related special health issues by the epidemiological surveillance network;

(b)case definitions concerning each communicable disease and related special health issue subject to epidemiological surveillance, in order to ensure the comparability and compatibility at Union level of the collected data;

(c)procedures for the operation of the epidemiological surveillance network as developed in application of Articles 5, 10 and 11 of Regulation (EC) No 851/2004.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).

On duly justified imperative grounds of urgency related to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread between the Member States, the Commission may adopt the measures referred to in points (a) and (b) through immediately applicable implementing acts in accordance with the procedure referred to in Article 18(3).

Article 7 - Ad hoc monitoring

1. Following an alert notified pursuant to Article 9 concerning a threat to health as referred to in point (iii) of point (a) of Article 2(1) and in points (b), (c) or (d) of Article 2(1), the Member States shall, in liaison with the Commission and on the basis of the available information from their monitoring systems, inform each other through the EWRS and, if the urgency of the situation so requires, through the HSC about developments with regard to the threat concerned at national level.

2. The information transmitted pursuant to paragraph 1, shall include in particular any change in geographical distribution, spread and severity of the threat concerned and of the means of detection, if available.

3. The Commission shall, by means of implementing acts, adopt, where necessary, the case definitions to be used for ad hoc monitoring, in order to ensure the comparability and compatibility at Union level of the collected data.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).

On duly justified imperative grounds of urgency related to the severity of a serious cross-border threat to health or to the rapidity of its spread between the Member States, the Commission may adopt or update the case definitions referred to in the first subparagraph through immediately applicable implementing acts in accordance with the procedure referred to in Article 18(3).

CHAPTER IV - EARLY WARNING AND RESPONSE

Article 8 - Establishment of an early warning and response system

1. A rapid alert system for notifying at Union level alerts in relation to serious cross-border threats to health, an ‘Early Warning and Response System’ (EWRS), is hereby established. The EWRS shall enable the Commission and the competent authorities responsible at national level to be in permanent communication for the purposes of alerting, assessing public health risks and determining the measures that may be required to protect public health.

2. The Commission shall, by means of implementing acts, adopt procedures concerning the information exchange in order to ensure the proper functioning of the EWRS and the uniform implementation of Articles 8 and 9 and to avoid overlap of activities or conflicting actions with existing structures and mechanisms for monitoring, early warning and combating serious cross-border threats to health.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).

Article 9 - 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, or it causes or may cause significant morbidity or mortality in humans, or it grows rapidly or may grow rapidly in scale, or it exceeds or may exceed national response capacity; and

(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 in accordance with Article 6 of the IHR, they shall at the latest simultaneously notify an alert in the EWRS, provided that the threat concerned falls within those referred to in Article 2(1) of this Decision.

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;

(i)personal data necessary for the purpose of contact tracing in accordance with Article 16;

(j)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 11, including information related to serious cross-border threats to health and public health measures related to serious cross-border threats to health transmitted through rapid alert and information systems established under other provisions of Union law or the Euratom Treaty.

Article 10 - Public health risk assessment

1. Where an alert is notified pursuant to Article 9, the Commission shall, where necessary for the coordination of the response at Union level and upon request of the HSC referred to in Article 17 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:

(a)the ECDC in accordance with Article 7(1) of Regulation (EC) No 851/2004 in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1) or point (d) of Article 2(1); and/or

(b)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 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 (16) in the case of a threat referred to in Article 2 of this Decision where the threat falls under the mandate of the EFSA; and/or

(c)other relevant Union agencies.

2. Where the risk assessment needed is totally or partially outside the mandates of the agencies referred to in paragraph 1, and it is considered necessary for the coordination of the response at Union level, the Commission shall, upon request of the HSC or its own initiative, provide an ad hoc risk assessment.

The Commission shall make the risk assessment available to the national competent authorities promptly through the EWRS. Where the risk assessment is to be made public, the national competent authorities shall receive it prior to its publication.

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.

3. 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.

Article 11 - Coordination of response

1. Following an alert pursuant to Article 9, on a request from the Commission or a Member State and on the basis of the available information, including the information referred to in Article 9 and the risk assessments referred to in Article 10, Member States shall consult each other within the HSC and in liaison with the Commission with a view to coordinating:

(a)national responses 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 Decision;

(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 and to healthcare professionals.

2. Where a Member State intends to adopt public health measures to combat a serious cross-border threat to health, it shall, before adopting those measures, inform and consult the other Member States and the Commission on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the 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, immediately upon adoption, inform the other Member States and the Commission on the nature, purpose and scope of those measures.

4. In the event of a serious cross-border threat to health overwhelming the national response capacities, an affected Member State may also request assistance from other Member States through the Community Civil Protection Mechanism established by Decision 2007/779/EC, Euratom.

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 to 3.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).

CHAPTER V - EMERGENCY SITUATIONS

Article 12 - Recognition of emergency situations

1. The Commission may recognise a situation of public health emergency in relation to:

(a)epidemics of human influenza considered to have pandemic potential, where the Director-General of the WHO has been informed and has not yet adopted a decision declaring a situation of pandemic influenza in accordance with the applicable rules of the WHO; or

(b)cases other than that referred to in point (a) where the Director-General of the WHO has been informed and has not yet adopted a decision declaring a public health emergency of international concern in accordance with the IHR, and where:

(i)the serious cross-border threat to health in question endangers public health at the Union level;

(ii)medical needs are unmet in relation to that threat, which means that no satisfactory method of diagnosis, prevention or treatment is authorised in the Union or, despite the existence of such a method, the authorisation of a medicinal product would nonetheless be of major therapeutic advantage to those affected.

2. The Commission shall adopt the measure referred to in paragraph 1 by means of implementing acts.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).

On duly justified imperative grounds of urgency related to the severity of a serious cross-border threat to health or to the rapidity of its spread among Member States, the Commission may recognise situations of public health emergency pursuant to paragraph 1 through immediately applicable implementing acts in accordance with the procedure referred to in Article 18(3).

3. The Commission shall inform the Director-General of the WHO of the adoption of the measures referred to in paragraph 1.

Article 13 - Legal effects of recognition

The recognition of an emergency situation pursuant to Article 12(1) shall have the sole legal effect of enabling point 2 of Article 2 of Regulation (EC) No 507/2006 to apply or, where the recognition specifically concerns epidemics of human influenza considered as having a pandemic potential, of enabling Article 21 of Regulation (EC) No 1234/2008 to apply.

Article 14 - Termination of the recognition

The Commission shall, by means of implementing acts, terminate the recognition referred to in Article 12(1) as soon as one of the applicable conditions laid down therein is no longer met.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).

Termination of the recognition, as referred to in the first paragraph, shall not affect the validity of marketing authorisations granted on the basis of Regulation (EC) No 507/2006 to medicinal products referred to in point 2 of Article 2 thereof or granted in accordance with the procedure referred to in Article 21 of Regulation (EC) No 1234/2008.

CHAPTER VI - PROCEDURAL PROVISIONS

Article 15 - Designation of national authorities and representatives

1. Each Member State shall designate, by 7 March 2014:

(a)the competent authorities responsible within the Member State for epidemiological surveillance as referred to in Article 6;

(b)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 Articles 8, 9 and 10;

(c)one representative and an alternate in the HSC referred to in Article 17.

2. Member States shall notify the Commission and other Member States of the designations referred to in paragraph 1 and of any change thereof. In the event of such change, the Commission shall distribute immediately to the HSC an updated list of such designations.

3. The Commission shall make publicly available the updated list of the authorities designated in accordance with points (a) and (c) of paragraph 1, as well as the updated list of the authorities to which the representatives in the HSC belong.

Article 16 - Protection of personal data

1. In the application of this Decision, personal data shall be processed in accordance with Directive 95/46/EC and Regulation (EC) No 45/2001. In particular, appropriate technical and organisational measures shall be taken to protect such personal data against accidental or illegal destruction, accidental loss, or unauthorised access and against any form of illegal processing.

2. The EWRS shall include a selective messaging functionality allowing personal data to be communicated only to national competent authorities involved in contact tracing measures. That selective messaging functionality shall be designed and operated so as to ensure safe and lawful exchange of personal data.

3. Where competent authorities implementing contact tracing measures communicate personal data necessary for contact tracing purposes through the EWRS pursuant to Article 9(3), they shall use the selective messaging functionality referred to in paragraph 2 of this Article and communicate the data only to the other Member States involved in the contact tracing measures.

4. When circulating the information referred to in paragraph 3, the competent authorities shall refer to the alert communicated previously through the EWRS.

5. Messages containing personal data shall automatically be erased from the selective message functionality 12 months after the date of their posting.

6. Where a competent authority establishes that notification of personal data made by it pursuant to Article 9(3) has subsequently proved to be in breach of Directive 95/46/EC because that notification was unnecessary for the implementation of the contact tracing measures at issue, it shall inform immediately the Member States to which that notification was transmitted.

7. In relation to their responsibilities to notify and rectify personal data through the EWRS, the national competent authorities shall be regarded as controllers within the meaning of point (d) of Article 2 of Directive 95/46/EC.

8. In relation to its responsibilities concerning storage of personal data, the Commission shall be regarded as a controller within the meaning of point (d) of Article 2 of Regulation (EC) No 45/2001.

9. The Commission shall adopt:

(a)guidelines aimed at ensuring that the day-by-day operation of the EWRS complies with Directive 95/46/EC and Regulation (EC) No 45/2001;

(b)a recommendation providing an indicative list of the personal data that may be exchanged for the purpose of the coordination of contact tracing measures.

Article 17 - Health Security Committee

1. A Health Security Committee, composed of representatives of the Member States designated under point (c) of Article 15(1), is hereby established.

2. The HSC shall have the following tasks:

(a)supporting the exchange of information between the Member States and the Commission on the experience acquired with regard to the implementation of this Decision;

(b)coordination in liaison with the Commission of the preparedness and response planning of the Member States in accordance with Article 4;

(c)coordination in liaison with the Commission of the risk and crisis communication and responses of the Member States to serious cross-border threats to health, in accordance with Article 11.

3. The HSC shall be chaired by a representative of the Commission. The HSC shall meet at regular intervals and whenever the situation requires, on a request from the Commission or a Member State.

4. The secretariat shall be provided by the Commission.

5. The HSC shall adopt, by a majority of two thirds 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 at high level and working groups;

(b)the participation of experts in plenary meetings, the status of observers, including from third countries;

(c)the arrangements for the HSC to examine 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; those arrangements shall not affect the obligations of the Member States under Articles 4 and 11 of this Decision.

Article 18 - Committee procedure

1. The Commission shall be assisted by a committee on serious cross-border threats to health. That Committee shall be a committee within the meaning of Article 3(2) of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

Article 19 - Reports concerning this Decision

The Commission shall submit to the European Parliament and the Council by 7 November 2015, and every three years thereafter a report on the implementation of this Decision. The report shall include, in particular, an assessment of the operation of the EWRS and of the epidemiological surveillance network, as well as information on how the mechanisms and structures established under this Decision complement other alert systems at Union level and under the Euratom Treaty to protect public health effectively, while avoiding structural duplications. The Commission may accompany the report with proposals to modify the relevant Union provisions.

CHAPTER VII - FINAL PROVISIONS

Article 20 - Repeal of Decision No 2119/98/EC

1. Decision No 2119/98/EC is hereby repealed.

2. References to the repealed Decision shall be construed as references to this Decision.

Article 21 - Entry into force

This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.

Article 22 - Addressees

This Decision is addressed to the Member States.