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Ref. Ares(2021)3719155 - 07/06/2021 Annex to 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) Fields marked with * are mandatory. INTRODUCTION 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. 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. For further guidance on how to fill this template please consult the explanatory note. Providing information as requested for in this survey is a legal obligation under Article 4 of Decision No 1082 /2013/EU on serious cross-border threats to health and under Implementing Decision 2014/504/EU. PRIVACY STATEMENT Before completing the form, please read carefully the privacy statement to conform to European data protection regulations. Acceptance of the terms and conditions for the 2014-2015 reporting exercise, for information only. I have read and accept the terms and conditions related to this survey * 1  Before completing the form, please read carefully the privacy statement to conform to European data protection regulations. Acceptance of the terms and conditions for the 2017 reporting exercise. I have read and accept the terms and conditions related to this survey In case you wish to contact the Unit responsible for this survey, please send an email to: SANTE-C3- [email protected] CONTACT INFORMATION * Country Estonia-EE * Name of contact point Martin Kadai, Health Board * Postal address of contact point Paldiski str. 81, Tallinn * Email address of contact point Please provide the full email address for possible contact duing the data analysis phase. [email protected] Date of first reporting Reporting date in 2014-2015 reporting exercise, only for information. 13/03/2015 * Date Date of reporting in 2017 reporting exercise. 03/11/2017 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: Please upload the WHO Questionnaire for Monitoring Progress 2  82aac8e4-4650-47ee-a695-f96f2a0cbf9f/IHRMonitoringQuestionnaire2014_ESTONIAfin.pdf Please upload if possible the country profile report dd5e02f5-50a6-4603-addd-16f684c0b7ad/IHR_profile_-_Estonia_2016.png Please note that the size of the files to upload can’t exceed 1 MB. * 2.1. Have you now completed your implementation of the IHR core capacities? (In accordance to IHR monitoring questionnaire) Yes No * 2.2. If no what was the reason? National legislation need to be updated; designation of PoE is in progress * 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. Developing of recommended EU specific standards and guidelines (including to EU external borders) for harmonization of preparedness planning at EU level. 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). 3  If you wish to upload additional documents related to issues on implementation of IHR (Chapter I), please use the options below. Please note that the size of the files to upload can’t exceed 1 MB. Document 1 Document 2 Document 3 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? If you select "Not applicable", please provide the reason why in the comment box at the end of this section. Yes No Not applicable Not known 4 5.2. If yes, for which types of threats falling under the scope of Decision No 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 If you select "Not applicable", please provide the reason why in the comment box at the end of this section. Yes No Not applicable Not known * - Foodborne diseases * - Zoonotic diseases * - Waterborne diseases * - Other communicable diseases, please specify If you select "Not applicable", please provide the reason why in the comment box at the end of this section. Not Not Yes No applicable known * 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? If you select "Not applicable", please provide the reason why in the comment box at the end of this section. Not Not Yes No applicable known * 6.1. Energy * 6.2. Information communication technology * 6.3. Transport * 6.4. Water for healthcare facilities, pharmaceutical operations, sanitation services * 6.5. Agriculture including the veterinary sector * 6.6. Food safety 5  * 6.7. Food supply 6.8. Chemical industry * 6.9. Industry providing pharmaceuticals and other consumables for the healthcare sector * 6.10. Security and emergencies police, fire services and ambulance services * 6.11. Local environmental services * 6.12. Funeral services * 6.13. Military * 6.14. Civil protection * 6.15. Administration and government units * 6.16. Scientific facilities * 6.17. Cultural and media facilities * 6.18. Voluntary sector * 6.19. Other sector(s) 7. Are Standard Operating Procedures (SOP) available for coordination of the health sector with any of the following sectors? Not Yes No known * 7.1. Energy * 7.2. Information communication technology * 7.3. Transport * 7.4. Water for healthcare facilities, pharmaceutical operations, sanitation services * 7.5. Agriculture including the veterinary sector * 7.6. Food safety * 7.7. Food supply * 7.8. Chemical industry * 7.9. Industry providing pharmaceuticals and other consumables for the healthcare sector * 7.10. Security and emergencies police, fire services and ambulance services * 7.11. Local environmental services * 7.12. Funeral services 6  * 7.13. Military * 7.14. Civil protection * 7.15. Administration and government units * 7.16. Scientific facilities * 7.17. Cultural and media facilities * 7.18. Voluntary sector * 7.19. Other sector(s) 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) 1) Energy; 2) Information communication technology 3) Transport 4) Water for healthcare facilities, pharmaceutical operations, sanitation services 5) Military * 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. In accordance with the Estonian Emergency Act, which is the core legislative act regulating emergency preparedness, planning and response and also continuous operation of critical services (ENG - https://www. riigiteataja.ee/en/eli/513062017001/consolide) the Government of the Republic shall establish by an order a list of those events concerning which a risk assessment shall be prepared, and shall appoint competent 7  authorities of executive power to prepare the emergency risk assessments. There are overall 6 events listed concerning which a risk assessment shall be prepared. For example one of the events is health care event. For all possible health related events (epidemics, mass poisoning etc.) which possibly may lead to an emergency, an risk assessment shall be conducted. Risk assessment consists of worst possible scenario, followed by assessing the probability and results of it and mapping the capacities and possible shortages of capacities. The leading authority shall involve all other relevant authorities and partners in process of preparing a risk assessment and all involved parties (including relevant ministries) approve the risk assessment after finalizing it. The same principle applies to preparing emergency plans. So interoperability between the health sector and other sectors is ensured through interactive involvement already in emergency preparation activities. In case of an emergency appointed representatives of relevant authorities and partners are involved trough the management structure for resolving an emergency of the leading authority. As a supportive strategic coordination structure there is also a permanent crisis committee of the Government of the Republic, which shall among other things assist, if need be, authorities resolving an emergency with a national effect or of particular severity in the organisation of exchange of information and in the co-ordination of resolving the emergency. Also there are permanent regional crisis committees which shall among other things assist, if need be, authorities resolving an emergency with a regional effect in the organisation of exchange of information and in the co-ordination of resolving the emergency. Both committees are permanent and involved in planning and response phase and activities. * 9.2. How is the national representation in the Health Security Committee linked to the structure(s)? National representation in the Health Security Committee is an alternative member of the permanent crisis committee of the Government of the Republic and also alternative member of the permanent regional crisis committees. * 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. On operational level the same principle applies as on strategic level (comment of the p 9.1.). Interoperability in case of crisis is ensured through involvement of all representatives of relevant partners into crisis management structure of the leading authority. It is up to the leading authority to involve all relevant partners already in emergency planning process but also in case of crisis. 8 * 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): The authority coordinating the resolution of an emergency shall orgianize an exercises at least once every two years. At least once every four years the Ministry of the Interior organises an exercise for resolving two or more emergencies or an emergency that has led to the declaration of an emergency situation. If you wish to upload additional documents related to issues on interoperability between health sector and other sectors (Chapter II), please use the options below. Please note that the size of the files to upload can’t exceed 1 MB. Document 1 Document 2 Document 3 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 9  disruption of a business function and process and gathers information needed to develop recovery strategies. * 13.1. Are there national business continuity plans (BCP) 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 No 1082/2013/EU? Please note that question 14 related to generic BCP and 15 related to specific BCP will be displayed only if "Yes" is the answer to this question. Yes No Not known * 13.2. Are these national business continuity plans generic (see question 14) or specific (see question 15)? Generic business continuity plans. There are two types of business continuity plans - one prepared by the organiser of the vital services and plans prepared by each service provider (for instance hospital or ambulance care provider). * 14. If yes, are there generic business continuity plans at national level? Questions related to generic business continuity plans will be displayed in a new page and depend on the "Yes" answer to this question. Yes No * 15. If yes, are there business continuity plans specific to a disease, disease group or threat in accordance with Article 2 of Decision No 1082/2013/EU? Questions related to specific business continuity plans will be displayed in a new page and depend on "yes" annswer to this question. Yes No * 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): According to the Emergency Act there is a list of vital services and authorities organising continuity thereof. The Ministry of Economic Affairs and Communications shall organise the continuity of the following vital 10  services: 1) electricity supply; 2) natural gas supply; 3) liquid fuel supply; 4) ensuring the operability of national roads; 5) phone service; 6) mobile phone service; 7) data transmission service; 8) digital identification and digital signing. The Ministry of Social Affairs shall organise the continuity of emergency care for the purposes of the Health Services Organisation Act. The Bank of Estonia shall organise the continuity of the following vital services: 1) payment services; 2) cash circulation. Local authorities who organise services provided by a provider of a vital service and on whose territory lives over 10,000 residents organise in their administrative territory the continuity of the following vital services: 1) district heating; 2) ensuring the operability of local roads; 3) water supply and sewerage. The main obligations of the authority organising continuity of vital services are: 1) coordinate the ensuring of the continuity of the vital service, considering the risk dependency of vital services; 2) advise providers of vital services; 3) exercise supervision over ensuring the continuity of vital services, including over the implementation of measures that prevent interruptions of vital services; 4) approve the continuity risk analyses and plans of providers of vital services; 5) coordinate the resolution of an emergency, prepare an emergency response plan and organise risk communication and crisis management exercises. The main obligations of the service provider are: 1) prepare the continuity risk assessment and plan of the vital service provided thereby; 2) implement measures that prevent interruptions of the vital service, including reduce the dependency on other vital services, essential contract partners, suppliers and information systems through duplicating technical systems, contracts, staff and other means important to the provision of the service, using alternative solutions, having and stocking necessary resources and other similar actions; 3) ensure the capability to guarantee the continuity of and to quickly restore the service provided thereby during an emergency or another similar situation, including in the event of a technical failure or an interruption of the supply or another vital service; 4) immediately notify the authority organising the continuity of the vital service of an interruption of the vital service, a risk of an interruption, an event significantly interfering with the continuity of the vital service or an impending risk of such an event; 5) participate in resolving an emergency according to the emergency response plan; 6) provide the authority organising the continuity of the vital service with information on the provision of the vital service at the request thereof; 7) organise exercises in order to verify the continuity of the vital service provided thereby at least once every two years. If you wish to upload additional documents related to issues on business continuity planning (Chapter III), please use the options below: 11  Please note that the size of the files to upload can’t exceed 1 MB. Document 1 Document 2 Document 3 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 wh enever substantially revising national preparedness planning at their own initiative and independently of any request by the Commission. * 18. When have you made substantial revisions to your national preparedness planning? Please submit details of substantial changes in the format provided under Chapters I, II and III of this Annex. Please indicate which plans were revised and the dates when the revision took place. The new Emergency Act entered into force on July 2017. There are some relevant amendments in the new Act compared to previous one. However the main principles of the emergency preparedness and response remained the same. The English version of the new Emergency Act can be found at the following link: https://www.riigiteataja.ee/en/eli/513062017001/consolide Useful links Implementing decision 2014/504/EU (http://eur-lex.europa.eu/legal-content/EN/TXT/? qid=1503923331639&uri=CELEX:32014D0504) Decision serious crossborder health threats 1082/2013/EU (http://eur-lex.europa.eu/legal-content/EN/TXT/? uri=CELEX:32013D1082&qid=1503923209141) Background Documents 12 Explanatory note Privacy statement Contact [email protected] 13 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Public health Health security Luxembourg SANTE.DDG1.C.3/LJ/tm (2021) To the Permanent Representation of Estonia Subject: Consultation pursuant to Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents – Ref. GestDem 2020/7562 Dear Sir, / Dear Madam, The Commission has received an application for access to documents under Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. As you know, this Regulation grants citizens a right of access to documents held by the Commission, subject to some exceptions on grounds of public or private interest. Article 4(5) of this Regulation provides that a Member State may request the institutions not to disclose a document originating from that Member State without its prior agreement. The application concerns the following report extracted from the EU survey questionnaire from the preparedness reporting cycle of 2017 under Article 4 of Decision 2013/1082/EU on Serious cross border threats to health, which include data originating from your authorities on your preparedness status. You will find the data concerning your country attached to this message. We would like to consult your authorities in order to know whether they oppose disclosure of the concerned data or parts of them. In case they do, I draw your attention to the fact that, according to the judgment of the Court of Justice of 18 December 2007[1], they need to provide the Commission with explicit reasons capable of justifying the application of one or more exceptions laid down in Article 4 (1) to (3) of Regulation 1049/2001. In this respect, it is worth mentioning in particular paragraph 86 of the said judgment, according to which ... an institution which receives a request for access to a document originating from a Member State and that Member State must, once that request has been notified by the institution to the Member State, commence without delay a genuine dialogue concerning the possible application of the exceptions laid down in Article 4(1) to (3) of Regulation No 1049/2001, while paying attention in particular to the need to [1] Case C 64/05 Ρ Sweden/ Commission, ECR 2007 p. I-11389, para 66 and case-law cited Commission européenne, 2920 Luxembourg, LUXEMBOURG - Tel. +352 43011 enable the institution to adopt a position within the time-limits within which Articles 7 and 8 of the regulation require it to decide on the request for access. According to paragraphs 88 of the above mentioned judgment The institution cannot accept a Member State's objection to disclosure of a document originating from that State if the objection gives no reasons at all or if the reasons are not put forward in terms of the exceptions listed in Article 4(1) to (3) of Regulation No 1049/2001. Where, despite an express request by the institution to the Member State to that effect, the State still fails to provide the institution with such reasons, the institution must, if for its part it considers that none of those exceptions applies, give access to the document that has been asked for. Based on our prima facie assessment, it would seem that the document is not covered by any of the exceptions of Article 4 of Regulation 1049/2001, subject only to possible redactions of personal data, in accordance with Article 4(1)(b) of Regulation 1049/2001. In the light of the above, should your authorities wish to oppose disclosure of the concerned document or parts thereof, they are invited to provide the detailed and motivated reasons on which they rely to consider that one or more of the exceptions of Regulation 1049/2001 applies to the said document. In order to allow us to reply to the applicant within the time limit of 15 working days laid down in Regulation No 1049/2001, we would be grateful if you could let us know as soon as possible, and in any case within 5 working days upon receipt of this letter, the position of your authorities as regards the document concerned. If your reply is not received within the prescribed time limit, we will adopt a position in accordance with the rules laid down in Regulation No 1049/2001, while taking account of your authorities' lawful interests on the basis of the information in our possession. In view of the short period allowed for the Commission's reply under Regulation No 1049/2001, we would be grateful if you could reply by e-mail to: [email protected] Thank you in advance for your assistance. Yours faithfully, Ingrid KELLER Enclosure: PreparednessResponse-SeriousCrossborderThreatstoHealth_Estonia 03-11-2017.pdf 2 Saatja: Kirke Härma-Tamme <[email protected]> Saadetud: 09.08.2021 14:06 Adressaat: SM Info <[email protected]> Teema: FW: Access to documents_GestDem 2020/7562 - MS consultation - EE - reminder Manused: image001.png; EE_Gestdem 2020-7562 letter on EU Survey reports.pdf; PreparednessResponse-SeriousCrossborderThreatstoHealth_Estonia 03-11-2017.pdf.pdf Tere Edastan pöördumise, mille osas küsitakse EE seisukohta. Palun seisukohta hiljemalt 12. augusti õhtuks. Mittenõustumise korral palun edastada inglisekeelsed põhjendused. Tagasisidet oodates Kirke Härma-Tamme Referent Õiguspoliitika osakond Justiitsministeerium From: [email protected] <[email protected]> Sent: Wednesday, July 28, 2021 7:15 PM To: [email protected]; Age Inkinen <[email protected]>; [email protected]; Mariko Jõeorg- Jurtšenko <[email protected]>; Nele Hollo <[email protected]>; Kirke Härma-Tamme <[email protected]>; Aaro Mõttus <[email protected]>; [email protected] Cc: [email protected] Subject: FW: Access to documents_GestDem 2020/7562 - MS consultation - EE - reminder Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear colleagues, Unless mistaken, we received no answer from your services about this access to documents request. Would it be possible for you to provide us with a reply before Friday 13 August please? Thank you in advance, Best regards, SANTE C3 Secretariat SANTE C3 - European Commission DG SANTE | Health and Food Safety | Unit C3 - Health Security HTC | 11, rue Eugène Ruppert LU-2920 Luxembourg [email protected] From: SANTE CONSULT-C3 <[email protected]> Sent: Wednesday, June 16, 2021 7:59 PM To: [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected] Cc: SANTE CONSULT-C3 <[email protected]> Subject: Access to documents_GestDem 2020/7562 - MS consultation - EE Dear Sir/Madam, Please find attached documents from KELLER Ingrid (SANTE.DDG1.C.3) dated 16/06/2021. Best regards, SANTE C3 Secretariat SANTE C3 - European Commission DG SANTE | Health and Food Safety | Unit C3 - Health Security HTC | 11, rue Eugène Ruppert LU-2920 Luxembourg [email protected]