COMMISSION IMPLEMENTING DECISION

of 25 July 2014

implementing Decision No 1082/2013/EU of the European Parliament and of the Council with regard to the template for providing the information on preparedness and response planning in relation to serious cross-border threats to health

(notified under document C(2014) 5180)

(Text with EEA relevance)

(2014/504/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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 (1), and in particular Article 4(6) thereof,

Whereas:

Decision No 1082/2013/EU lays down mechanisms and structures for coordinating responses to serious cross-border threats to health, including preparedness and response planning related to such responses.

Pursuant to Article 4(1) of Decision No 1082/2013/EU, Member States and the Commission are to consult each other within the Health Security Committee (HSC) in relation to preparedness and response planning with a view to sharing best practice and experience, promoting interoperability of national preparedness planning, addressing the intersectoral dimension at Union level, and supporting the implementation of core capacity requirements for surveillance and response as referred to by the International Health Regulations (2005) (IHR).

Article 4(2) of Decision No 1082/2013/EU lays down the information on preparedness and response planning at national level and stipulates that Member States are to provide this information to the Commission by 7 November 2014 and then every three years thereafter.

Pursuant to Article 4(3) of Decision No 1082/2013/EU, Member States are to inform the Commission on substantial revisions of their national preparedness and response planning.

Pursuant to Article 4(5) of Decision No 1082/2013/EU, the Commission is to analyse the information received from the Member States in accordance with Article 4(2) and (3) and to prepare a synthesis or thematic progress report. For the purpose of Article 4(1), the Commission is to initiate discussion in the HSC, in a timely manner, and, where appropriate, on the basis of this report.

Pursuant to Article 4(6) of Decision No 1082/2013/EU, the Commission is to adopt by means of implementing acts templates to be used by Member States when providing the information on their preparedness and response planning, as referred to in Article 4(2) and (3) in order to ensure its relevance to the objectives identified in Article 4(1) and its comparability.

In order to avoid duplicate reporting, the information already provided by Member States to the World Health Organisation (WHO) in relation to implementation of the core capacities for preparedness and response planning should be used for the purpose of reporting in accordance with Article 4(2)(a) of Decision No 1082/2013/EU.

The measures provided for in this Decision are in accordance with the opinion of the Committee on serious cross-border threats to health,

HAS ADOPTED THIS DECISION:

Article 1

Annex to this Decision sets out the template to be used by the Member States when providing the information on their preparedness and response planning in relation to serious cross border threats to health according to Article 4(2) and (3) of Decision No 1082/2013/EU.

Article 2

This Decision is addressed to the Member States.

(1) OJ L 293, 5.11.2013, p. 1.

ANNEX

Template to be used by the Member States for providing the information on preparedness and response planning in relation to serious cross border threats to health

Country:

Name and address of contact point:

Date:

It is at the discretion of the Member States to select the appropriate contact point to reply to the questions raised below. It would, however, be useful if the answers could be provided in collaboration with the national contact point for the implementation of the International Health Regulations (IHR). All questions should be completed. For each question please mark only one appropriate value (yes, no, not applicable or not known) if such a choice is given, or provide brief explanatory text if the question requires an open response. If a question is not applicable for your country context, please indicate this in the comment box provided at the end of each section along with the reason why it is not applicable. In line with Article 4(2)(b) and (c) of Decision No 1082/2013/EU the obligation to provide information requested in Chapters II (Interoperability) and III (Business continuity) shall only apply if such measures or arrangements are in place or are provided for as part of national preparedness and response planning.

I. Implementation of IHR core capacities as referred to in Article 4(2)(a) of Decision No 1082/2013/EU

1 Please provide a copy of your latest reply to the WHO Questionnaire for Monitoring Progress in the Implementation of the IHR Core Capacities in States Parties, and if possible the country profile report compiled by the WHO. In addition, please provide the following information: 2.1 Have you now completed your implementation of the IHR core capacities? yes no 2.2 If no what was the reason? 3 Please present — where you consider appropriate — your ideas what action the Commission, the EU agencies or Member States should take to ensure that the WHO core capacities are maintained and strengthened in the future. 4 Please list — where you consider appropriate — any comments or clarifications to the questions above and if considered necessary list any relevant activities that your country has conducted which are not reflected in this questionnaire (additional pages may be attached if necessary).

II. Interoperability between the health sector and other sectors as referred to in Article 4(2)(b) of Decision No 1082/2013/EU

In line with Article 4(2) of Decision No 1082/2013/EU the obligation to provide information shall only apply if such measures or arrangements are in place or are provided for as part of national preparedness and response planning.

National coordination structures for cross-sectoral incidents as referred to in Article 4(2)(b)(i) of Decision No 1082/2013/EU are understood as structures empowered with strategic administrative and policy making functions, in particular with regard to chain of command. This could be a body, committee or a task force. National emergency operational centres as referred to in Article 4(2)(b)(ii) of Decision No 1082/2013/EU are understood as operational structures and/or arrangements aiming at providing logistical functions and tools, in particular with regard to communication, in the event of emerging serious cross-border threats to health.

5.1 Are other sectors involved in the preparedness and response planning activities of the health sector? yes no not applicable not known 5.2 If yes, for which types of threats falling under the scope of Decision 1082/2013/EU? 5.2.1 threats of biological origin, consisting of: 5.2.1.1 communicable diseases, please specify further if possible, for example — foodborne diseases — oonotic diseases — waterborne diseases — other communicable diseases, please specify 5.2.1.2 antimicrobial resistance and healthcare-associated infections related to communicable diseases 5.2.1.3 biotoxins or other harmful biological agents not related to communicable diseases 5.2.2 threats of chemical origin 5.2.3 threats of environmental origin 5.2.4 threats of unknown origin 5.2.5 events which may constitute or have been declared public health emergencies of international concern under the IHR, provided they fall under the categories above





6 Which of the following sectors does your country identify as critical in case of an emergency associated with a serious cross-border threat to health? 7 Are Standard Operating Procedures (SOP) available for coordination of the health sector with any of the following sectors? yes no not applicable not known yes no not known energy 6.1 7.1 information communication technology 6.2 7.2 transport 6.3 7.3 water for healthcare facilities, pharmaceutical operations, sanitation services 6.4 7.4 agriculture including the veterinary sector 6.5 7.5 food safety 6.6 7.6 food supply 6.7 7.7 chemical industry 6.8 7.8 industry providing pharmaceuticals and other consumables for the healthcare sector 6.9 7.9 security and emergencies police, fire services and ambulance services 6.10 7.10 local environmental services 6.11 7.11 funeral services 6.12 7.12 military 6.13 7.13 civil protection 6.14 7.14 administration and government units 6.15 7.15 scientific facilities 6.16 7.16 cultural and media facilities 6.17 7.17 voluntary sector 6.18 7.18 other sectors, please specify 6.19 7.19





8.1 Which are the critical sectors for which the health sector in your country has no coordination arrangements in place? (reply optional) 8.2 Which are the priority sectors for which coordination with the health sector should be improved? Please list in the order of priority. (reply optional) 9.1 Please describe the arrangements for strategic coordination structures (national law or SOPs) in place now 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. Please list the sectors covered by these coordination structures. 9.2 How is the national representation in the Health Security Committee linked to the structure(s)? 10 Please describe the arrangements for operational centres (crisis centres) (national law or SOPs)in place 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. Please list the sectors covered by these coordination structures. 11 Has the interoperability between the health sector and other sectors been tested at national level? yes no not known 12 Please list — where you consider appropriate — any comments or clarifications to the questions above and list any relevant activities that your country has conducted (for example either through exercises or triggered by real events) (additional pages may be attached if necessary):

III. Business continuity planning as referred to in Article 4(2)(c) of Decision No 1082/2013/EU

In line with Article 4(2) of Decision No 1082/2013/EU the obligation to provide information shall only apply if such measures or arrangements are in place or are provided for as part of national preparedness and response planning.

Business continuity planning refers to the management processes and integrated plans that maintain the continuity of an organisation's critical processes — those processes which enable a business to deliver critical services or products — in the case of a disruptive event. Business continuity encompasses all aspects of an organisation that play a role in sustaining critical processes, namely: people, premises, suppliers, technologies, data, etc. A business impact analysis (BIA) predicts the consequences of disruption of a business function and process and gathers information needed to develop recovery strategies.

13.1 Are there national business continuity plans in place aimed at ensuring the continuous delivery of critical services and products in the event of an emergency associated with serious cross-border threats to health as defined by Decision 1082/2013/EU? yes no not known 13.2 Are these national business continuity plans generic (see question 14) or specific (see question 15)? 14.1 Which health services do the generic plans address? Please indicate below. yes no not known 14.1.1 primary health service 14.1.2 hospitals 14.1.3 other services, please specify 14.2 If yes, which non-health sectors considered critical do these plans address? 14.2.1 energy 14.2.2 information communication technology 14.2.3 transport 14.2.4 water for healthcare facilities, pharmaceutical operations, sanitation services 14.2.5 agriculture including the veterinary sector 14.2.6 food safety 14.2.7 food supply 14.2.8 chemical industry 14.2.9 industry providing pharmaceuticals and other consumables for the healthcare sector 14.2.10 security and emergencies police, fire services and ambulance services 14.2.11 local environmental services 14.2.12 funeral services 14.2.13 military 14.2.14 civil protection 14.2.15 administration and government units 14.2.16 scientific facilities 14.2.17 cultural and media facilities 14.2.18 voluntary sector 14.2.19 other sectors, please specify 14.3 If yes, which of the following elements are included? yes If yes, please describe no not known 14.3.1 business impact analysis 14.3.2 prioritisation of critical services and functions through risk assessment to benefit from medical interventions 14.3.3 training, exercising, evaluating, updating, validating 14.3.4 identification of the personnel vital to maintain critical functions,dealing with staff absenteeism to minimise its impact on critical functions 14.3.5 providing clear command structures, delegations of authority and orders of succession 14.3.6 assessing the need to stockpile strategic reserves of supplies, material and equipment 14.3.7 identification of units, departments or services that could be downsized or closed 14.3.8 assigning and training alternative staff for critical posts 14.3.9 considering and testing ways of reducing societal disruption (e.g. telecommuting or working from home and reducing the number of physical meetings and travel) 14.3.10 planning for the need for social services support for essential workers 14.3.11 planning for the need for psychosocial support services to help workers remain effective 14.3.12 planning for the recovery phase 14.3.13 other element(s), please specify 15.1 Which specific serious cross-border threats to health do the specific plans address? Please indicate below in accordance with Article 2 of Decision 1082/2013/EU. 15.2 Which health services do these plans address? Please indicate below yes no not known 15.2.1 primary health service 15.2.2 hospitals 15.2.3 other services, please specify 15.3 If yes, which non-health sectors considered critical do these plans address? 15.3.1 energy 15.3.2 information communication technology 15.3.3 transport 15.3.4 water for healthcare facilities, pharmaceutical operations, sanitation services 15.3.5 agriculture including the veterinary sector 15.3.6 food safety 15.3.7 food supply 15.3.8 chemical industry 15.3.9 industry providing pharmaceuticals and other consumables for the healthcare sector 15.3.10 security and emergencies police, fire services and ambulance services 15.3.11 local environmental services 15.3.12 funeral services 15.3.13 military 15.3.14 civil protection 15.3.15 administration and government units 15.3.16 scientific facilities 15.3.17 cultural and media facilities 15.3.18 voluntary sector 15.3.19 other sectors, please specify 15.4 If yes, which of the following elements are included? yes If yes, please describe no not known 15.4.1 business impact analysis 15.4.2 prioritisation of critical services and functions through risk assessment to benefit from medical interventions 15.4.3 training, exercising, evaluating, updating, validating 15.4.4 identification of the personnel vital to maintain critical functions,dealing with staff absenteeism to minimise its impact on critical functions 15.4.5 providing clear command structures, delegations of authority and orders of succession 15.4.6 assessing the need to stockpile strategic reserves of supplies, material and equipment 15.4.7 identification of units, departments or services that could be downsized or closed 15.4.8 assigning and training alternative staff for critical posts 15.4.9 considering and testing ways of reducing societal disruption (e.g. telecommuting or working from home and reducing the number of physical meetings and travel) 15.4.10 planning for the need for social services support for essential workers 15.4.11 planning for the need for psychosocial support services to help workers remain effective 15.4.12 planning for the recovery phase 15.4.13 other element(s), please specify 16 Are there business continuity plans for Points of Entry as referred to in the IHR? yes no not known 17 Please list — where you consider appropriate — any comments or clarifications to the questions above and list any relevant activities that your country has conducted (additional pages may be attached if necessary):

IV. Revisions of national preparedness planning as referred to in Article 4(3) of Decision No 1082/2013/EU

The main purpose of this chapter is to obtain information on the state of play in the Member States. In accordance with Article 4(3) Member States are, however, to provide information by use of this template whenever substantially revising national preparedness planning at their own initiative and independently of any request by the Commission.