Commission Implementing Regulation (EU) 2023/1808 of 21 September 2023 setting out the template for the provision of information on prevention, preparedness and response planning in relation to serious cross-border threats to health in accordance with Regulation (EU) 2022/2371 of the European Parliament and of the Council

Type Implementing Regulation
Publication 2023-09-22
State In force
Text As published
Department European Commission, SANTE
Source EUR-Lex
articles 2

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

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22.9.2023 EN Official Journal of the European Union L 234/105

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU 1, and in particular Article 7(3) thereof,

Whereas:

HAS ADOPTED THIS REGULATION:

Article 1

The template to be used by Member States when providing information on their prevention, preparedness and response planning in relation to serious cross-border threats to health in accordance with Article 7(1) of Regulation (EU) 2022/2371, as is set out in the Annex to this Regulation, is adopted.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 21 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

ANNEX

Table of contents
A. International Health Regulations (IHR) 2005 capacities 108
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1. Policy, legal and normative Instruments to implement the International Health Regulations (IHR) 2005 108
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2. Financing 109
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3. Laboratory 110
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4. Surveillance 113
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5. Human resources 114
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6. Health emergency management 115
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Management of health emergency response 115
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Emergency logistic and supply chain management 118
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7. Health services provision 121
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8. Risk communication 124
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9. Points of entry (PoEs) and border health 125
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10. Zoonotic diseases and threats of environmental origin, including those due to the climate 126
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11. Chemical events 127
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B. Additional capacities as per Regulation (EU) 2022/2371 129
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12. Antimicrobial resistance (AMR) and Healthcare associated infections 129
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AMR 129
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Healthcare associated infections (HAIs) 134
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13. Union level coordination and support functions 135
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14. Research development and evaluations to inform and accelerate emergency preparedness 137
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15. Recovery elements 139
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16. Actions taken to improve gaps found in the implementation of prevention, preparedness, and response plans 139
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C. Other 141

A. INTERNATIONAL HEALTH REGULATIONS (IHR) 2005 CAPACITIES

Question Question Indicator
A.1.1 Regarding your Member State’s legal instruments for preparedness and response planning, please indicate your Member State’s corresponding level: Regarding your Member State’s legal instruments for preparedness and response planning, please indicate your Member State’s corresponding level: Indicator 1-5
A.1.1 level Indicator 1-5
A.1.1 Legal instruments do not incorporate coordination across national, regional, and local levels of government during a public health emergency 1 Indicator 1-5
A.1.1 Legal instruments incorporate coordination across national, regional, and local levels of government during a public health emergency 2 Indicator 1-5
A.1.1 Legal instruments incorporate coordination across national, regional, and local levels of government during a public health emergency. In addition, legal instruments also incorporate coordination with sectors responsible for critical infrastructure during a public health emergency 3 Indicator 1-5
A.1.1 Legal instruments incorporate coordination across national, regional, and local levels of government during a public health emergency. In addition, legal instruments also incorporate coordination with sectors responsible for critical infrastructure during a public health emergency. Moreover, the operational readiness of these legal instruments has been tested in the last 3 years 4 Indicator 1-5
A.1.1 As per level 4 and, in addition, there is a mechanism for reviewing and revising legal instruments (if needed based on recommendations from testing) 5 Indicator 1-5
A.1.1 — If level 5: has your country revised the legal instruments in the last 3 years? (yes/no) — If yes, please upload relevant links (optional for Member States): — Additional comments: — If level 5: has your country revised the legal instruments in the last 3 years? (yes/no) — If yes, please upload relevant links (optional for Member States): — Additional comments: Indicator 1-5
A.1.2 In the event of a public health emergency, do your country’s legal instruments for IHR 2005 implementation assign a clear decision-making process, which may comprise one or more authorities? (yes/no/other) — If other, please describe: In the event of a public health emergency, do your country’s legal instruments for IHR 2005 implementation assign a clear decision-making process, which may comprise one or more authorities? (yes/no/other) — If other, please describe: Not applicable (N/A)

2. Financing

Question Question Indicator
A.2.1 Regarding Member States’s planning to test the financial resources for contingency funding to respond to health threats, please indicate your Member State’s corresponding level: Regarding Member States’s planning to test the financial resources for contingency funding to respond to health threats, please indicate your Member State’s corresponding level: Indicator 1-5 or N/A
A.2.1 level Indicator 1-5 or N/A
A.2.1 Member State cannot answer the question [at central state level] N/A Indicator 1-5 or N/A
A.2.1 There are no plans to conduct tests of financial resources for contingency funding for response to health threats in the next 3 years 1 Indicator 1-5 or N/A
A.2.1 There are plans to conduct tests of financial resources for contingency funding for response to health threats in the next 3 years but this is on an ad hoc basis 2 Indicator 1-5 or N/A
A.2.1 There are plans to conduct tests of financial resources for contingency funding for response to health threats and this is to be conducted on a regular basis 3 Indicator 1-5 or N/A
A.2.1 Tests of financial resources for contingency funding for response to health threats have been and continue to be conducted on a regular basis 4 Indicator 1-5 or N/A
A.2.1 As per level 4, and, in addition, recommendations from the tests have been implemented and corresponding plans have been reviewed and revised 5 Indicator 1-5 or N/A
A.2.1 — Additional comments: Your Member State cannot answer this question at the central state level, due to governance and legislative frameworks? (yes) In this case, please indicate if national level recommendations/guidelines are sent to regional authorities (yes/no) If yes, please advise if at central level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges If not, please explain: — Additional comments: Your Member State cannot answer this question at the central state level, due to governance and legislative frameworks? (yes) In this case, please indicate if national level recommendations/guidelines are sent to regional authorities (yes/no) If yes, please advise if at central level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges If not, please explain: Indicator 1-5 or N/A
A.2.2 Does the Ministry of Health and Ministry of Finance of your Member State have dedicated procedures for the coordination of policies and activities in the case of a public health emergency? (yes/no/other) — If yes, please elaborate: (e.g., regular meetings, joint task force orworking group, guidelines, and regulatory measures, etc.) — If other, please describe: Does the Ministry of Health and Ministry of Finance of your Member State have dedicated procedures for the coordination of policies and activities in the case of a public health emergency? (yes/no/other) — If yes, please elaborate: (e.g., regular meetings, joint task force orworking group, guidelines, and regulatory measures, etc.) — If other, please describe: N/A

3. Laboratory

Question Question Indicator
A.3.1 Please indicate your Member State’s corresponding level in relation to the scaling up the laboratory testing capacity in the event of a public health emergency: Please indicate your Member State’s corresponding level in relation to the scaling up the laboratory testing capacity in the event of a public health emergency: Indicator 1-5
A.3.1 Level Indicator 1-5
A.3.1 There is no plan and organisation2 for scaling up the laboratory testing capacity in the event of a public health emergency 1 Indicator 1-5
A.3.1 A plan and organisation for scaling up the laboratory testing capacity in the event of a public health emergency is being developed 2 Indicator 1-5
A.3.1 There is a plan and organisation for scaling up the laboratory testing capacity in the event of a public health emergency, but the plan has not been tested in the last 3 years 3 Indicator 1-5
A.3.1 There is a plan and organisation for scaling up the laboratory testing capacity in the event of a public health emergency and this plan has been tested in a stress test in the last 3 years 4 Indicator 1-5
A.3.1 As per level 4 and, in addition, the system has been revised accordingly 5 Indicator 1-5
A.3.1 — Additional comments: — Additional comments: Indicator 1-5
A.3.2 Please indicate your Member State’s corresponding level regarding implementation of new nucleic acid amplification-based tests (NAATs) and adapted associated laboratory systems in the event of a novel pathogen emergence with pandemic potential: Please indicate your Member State’s corresponding level regarding implementation of new nucleic acid amplification-based tests (NAATs) and adapted associated laboratory systems in the event of a novel pathogen emergence with pandemic potential: Indicator 1-5
A.3.2 Level Indicator 1-5
A.3.2 In the context of my Member State, it would not be possible to implement new NAATs and adapt associated laboratory systems within 6 months. 1 Indicator 1-5
A.3.2 > 3 – 6 months 2 Indicator 1-5
A.3.2 > 1 – 3 months 3 Indicator 1-5
A.3.2 2 – 4 weeks 4 Indicator 1-5
A.3.2 < 2 weeks 5 Indicator 1-5
A.3.2 — Additional comments: — Additional comments: Indicator 1-5
A.3.3 Please indicate you Member State’s corresponding level, in an event of a public health emergency with pandemic potential requiring large-scale testing Please indicate you Member State’s corresponding level, in an event of a public health emergency with pandemic potential requiring large-scale testing Indicator 1-5 or N/A
A.3.3 Level Indicator 1-5 or N/A
A.3.3 Your Member State cannot answer due to difficulties to quantify NAAT capacity according to these levels N/A Indicator 1-5 or N/A
A.3.3 In an event of a public health emergency and where a validated NAAT is available, it would be possible to scale up diagnostic NAAT testing services to a weekly sample testing capacity corresponding to up to 0,01 % of the population in my Member State 1 Indicator 1-5 or N/A
A.3.3 In an event of a health emergency and where a validated NAAT is available, it would be possible to scale up diagnostic NAAT testing services to a weekly sample testing capacity corresponding to 0,01-0,1 % of the population in my Member State 2 Indicator 1-5 or N/A
A.3.3 In an event of a health emergency and where a validated NAAT is available, it would be possible to scale up diagnostic NAAT testing services to a weekly sample testing capacity corresponding to 0,1-1 % of the population in my Member State 3 Indicator 1-5 or N/A
A.3.3 In an event of a health emergency and where a validated NAAT is available, it would be possible to scale up diagnostic NAAT testing services to a weekly sample testing capacity corresponding to 1-2 % of the population in my Member State 4 Indicator 1-5 or N/A
A.3.3 In an event of a health emergency and where a validated NAAT is available, it would be possible to scale up diagnostic NAAT testing services to a weekly sample testing capacity corresponding to > 2 % of the population in my Member State 5 Indicator 1-5 or N/A
A.3.3 — If N/A, please quantify NAAT capacity according to your own proposal: — Additional comments: — If N/A, please quantify NAAT capacity according to your own proposal: — Additional comments: Indicator 1-5 or N/A
A.3.4 Does your Member State have access to additional sources of laboratory capacity for diagnostic services in an event where an increased capacity is needed (e.g. research or veterinary laboratories, etc.)? (yes/no/other) — If yes, please advise if this is by formal agreement or on an ad hoc basis. — If other, please describe: Does your Member State have access to additional sources of laboratory capacity for diagnostic services in an event where an increased capacity is needed (e.g. research or veterinary laboratories, etc.)? (yes/no/other) — If yes, please advise if this is by formal agreement or on an ad hoc basis. — If other, please describe: N/A
A.3.5 Does your Member State have the capacity for reporting laboratory testing results for national surveillance via an electronic reporting system? (yes/no/other) — If yes, is this reporting system capable of managing scaled up testing information? (yes/no) — If yes, is this reporting system capable of integrating input from different sources of laboratory capacities (e.g., research, hospitals, commercial or veterinary laboratories, etc.)? (yes/no) — If other, please describe: Does your Member State have the capacity for reporting laboratory testing results for national surveillance via an electronic reporting system? (yes/no/other) — If yes, is this reporting system capable of managing scaled up testing information? (yes/no) — If yes, is this reporting system capable of integrating input from different sources of laboratory capacities (e.g., research, hospitals, commercial or veterinary laboratories, etc.)? (yes/no) — If other, please describe: N/A
A.3.6 Please indicate if your Member State has access to high-containment laboratories i.e. biosafety level 3 or 4 laboratories: Does your Member State have access to a biosafety level 3 laboratory? (yes/no/other) — If no, does your Member State have a formal agreement with another EU/EEA country for this service? (yes/no) — If other, please describe: Does your Member State have access to a biosafety level 4 laboratory (yes/no/other) — If no, does your country have a formal agreement with another EU/EEA Member State for this service? (yes/no) — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security Please indicate if your Member State has access to high-containment laboratories i.e. biosafety level 3 or 4 laboratories: Does your Member State have access to a biosafety level 3 laboratory? (yes/no/other) — If no, does your Member State have a formal agreement with another EU/EEA country for this service? (yes/no) — If other, please describe: Does your Member State have access to a biosafety level 4 laboratory (yes/no/other) — If no, does your country have a formal agreement with another EU/EEA Member State for this service? (yes/no) — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security N/A
A.3.7 Does your Member State have the capacity for characterization of a novel pathogen by Next Generation Sequencing (NGS)? (yes/no/other) — If yes, are NGS data for national surveillance reported via an electronic reporting system? (yes/no) — If no, does your country have an arrangement with another Member State? (yes/no). — If yes, please indicate the Member State: — If other, please describe: Does your Member State have the capacity for characterization of a novel pathogen by Next Generation Sequencing (NGS)? (yes/no/other) — If yes, are NGS data for national surveillance reported via an electronic reporting system? (yes/no) — If no, does your country have an arrangement with another Member State? (yes/no). — If yes, please indicate the Member State: — If other, please describe: N/A
A.3.8 Does your Member State have a facility dedicated to validating newly introduced devices for the diagnosis of the novel pathogen? (yes/no/other) — If other, please describe: Does your Member State have a facility dedicated to validating newly introduced devices for the diagnosis of the novel pathogen? (yes/no/other) — If other, please describe: N/A

4. Surveillance

Question Question Indicator
A.4.1 Does your Member State’s surveillance system for acute respiratory infections cover all healthcare levels? (yes/no/other) — If other, please describe: Does your Member State’s surveillance system for acute respiratory infections cover all healthcare levels? (yes/no/other) — If other, please describe: N/A
A.4.2 Are the surveillance systems for Acute Respiratory Infection (ARI), Influenza -Like Illness (ILI) and Severe Acute Respiratory Infections (SARI) automated3 in your Member State? (yes/no/other) — If other, please describe: Are the surveillance systems for Acute Respiratory Infection (ARI), Influenza -Like Illness (ILI) and Severe Acute Respiratory Infections (SARI) automated3 in your Member State? (yes/no/other) — If other, please describe: N/A
A.4.3 Would your Member State’s surveillance system for respiratory infections be able to scale up during a pandemic (i.e., to increase the number of reporting sites, the breath of data collected, the timeliness of reporting, etc.)? (yes/no/other) — If other, please describe: Would your Member State’s surveillance system for respiratory infections be able to scale up during a pandemic (i.e., to increase the number of reporting sites, the breath of data collected, the timeliness of reporting, etc.)? (yes/no/other) — If other, please describe: N/A
A.4.4 Is your Member State able to monitor the following indicators on an ongoing basis and for the whole country’s territory, during a public health emergency (i.e. taking into account expanded capacities and/or new settings)? Is your Member State able to monitor the following indicators on an ongoing basis and for the whole country’s territory, during a public health emergency (i.e. taking into account expanded capacities and/or new settings)? N/A
A.4.4 yes/no N/A
A.4.4 Hospital bed capacity N/A
A.4.4 Hospital intensive care units’ capacity N/A
A.4.4 Hospital emergency rooms capacity N/A
A.4.4 Hospital utilisation N/A
A.4.4 Testing capacity N/A
A.4.4 Contact tracing capacity N/A
A.4.4 Other, please describe N/A
A.4.4 — Additional comments: — Additional comments: N/A
A.4.5 Does your country have a wastewater monitoring system in place for respiratory pathogens? (yes/no/other) — If other, please describe: Does your country have a wastewater monitoring system in place for respiratory pathogens? (yes/no/other) — If other, please describe: N/A
A.4.6 Does your country have plans and infrastructures for timely and ongoing assessment of a pandemic threat, i.e., for assessing: Does your country have plans and infrastructures for timely and ongoing assessment of a pandemic threat, i.e., for assessing: N/A
A.4.6 yes/no N/A
A.4.6 Transmissibility, route of transmission, effective reproduction number N/A
A.4.6 Severity N/A
A.4.6 Immunologic correlates of protection N/A
A.4.6 Vaccine effectiveness N/A
A.4.6 Epidemic trajectories and impact through mathematical modelling N/A
A.4.6 Other, please specify: Other, please specify: N/A
A.4.6 — Additional comments: — Additional comments: N/A

5. Human resources

Question Question Question Question Question Question Indicator
A.5.1 In the event of a public health emergency regarding a potential surge in demand of human resources, please indicate your Member State’s level: In the event of a public health emergency regarding a potential surge in demand of human resources, please indicate your Member State’s level: In the event of a public health emergency regarding a potential surge in demand of human resources, please indicate your Member State’s level: In the event of a public health emergency regarding a potential surge in demand of human resources, please indicate your Member State’s level: In the event of a public health emergency regarding a potential surge in demand of human resources, please indicate your Member State’s level: In the event of a public health emergency regarding a potential surge in demand of human resources, please indicate your Member State’s level: Indicator 1-5 or N/A
A.5.1 Hospital services Outpatient primary care services Laboratory services (outside of hospitals) Other public health services Indicator 1-5 or N/A
A.5.1 N/A Member State cannot answer the question at central state level Indicator 1-5 or N/A
A.5.1 Level 1 There is no mechanism to ensure a surge in human resources in the event of a public health emergency Indicator 1-5 or N/A
A.5.1 Level 2 There is no mechanism to ensure a surge in human resources in the event of a public health emergency but there is a plan to work on a strategy to have it in the coming 3 years Indicator 1-5 or N/A
A.5.1 Level 3 There is a mechanism to ensure a surge in human resource in the event of a public health emergency, but it is not a structured operational instrument nor is it routinely updated Indicator 1-5 or N/A
A.5.1 Level 4 There is a mechanism to ensure a surge in human resource in the event of a public health emergency which comprises a structured operational instrument that is routinely updated and participants are periodically trained Indicator 1-5 or N/A
A.5.1 Level 5 As per level 4 and, in addition, this mechanism is tested to ensure its functioning Indicator 1-5 or N/A
A.5.1 — Additional comments: Your country cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate whether national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please, explain — Additional comments: Your country cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate whether national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please, explain — Additional comments: Your country cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate whether national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please, explain — Additional comments: Your country cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate whether national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please, explain — Additional comments: Your country cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate whether national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please, explain — Additional comments: Your country cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate whether national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please, explain Indicator 1-5 or N/A
A.5.2 Please advise if regions within your Member State have agreements to receive/exchange human resource support in the health sector in case of need? (yes/no/other) — If other, please describe: Please advise if regions within your Member State have agreements to receive/exchange human resource support in the health sector in case of need? (yes/no/other) — If other, please describe: Please advise if regions within your Member State have agreements to receive/exchange human resource support in the health sector in case of need? (yes/no/other) — If other, please describe: Please advise if regions within your Member State have agreements to receive/exchange human resource support in the health sector in case of need? (yes/no/other) — If other, please describe: Please advise if regions within your Member State have agreements to receive/exchange human resource support in the health sector in case of need? (yes/no/other) — If other, please describe: Please advise if regions within your Member State have agreements to receive/exchange human resource support in the health sector in case of need? (yes/no/other) — If other, please describe: N/A

6. Health emergency management

Management of health emergency response

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