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Nimetamine ekspertgruppi

Sotsiaalministeerium · 12. mai 2026
Viit
1.4-2/1257-1
Registreeritud
12. mai 2026
Dokumendi liik
Sissetulev kiri
Adressaat
Permanent Representation of Estonia to the EU
Saabumis/saatmisviis
e-post
Funktsioon
1.4 EL otsustusprotsess ja rahvusvaheline koostöö
Sari
1.4-2 Rahvusvahelise koostöö korraldamisega seotud kirjavahetus (Arhiiviväärtuslik)
Toimik
1.4-2/2026
Vastutaja
Häli Tarum (Sotsiaalministeerium, Kantsleri vastutusvaldkond)
Lahendamise tähtaeg
26. mai 2026

Failid

  • 📎E-kiri.eml1138 KB
  • 📎Nomination letter - MCM EUCI Commission Expert Group 06_05_2026.pdf446 KB
  • 📎ToR _ MCM EUCI Commission Expert Group 06_05_2026 - Final version.pdf344 KB

Sisu (failidest)

Saatja: "Maret Voore" <[email protected]> Saaja: "Info - SOM" <[email protected]> Teema: FW: Nomination request: Informal Commission Expert Group on Medical Countermeasures (MCM) and EUCI (EU Classified Information) ​ - Ares(2026)4767469 Kuupäev: 2026-05-11 15:09 Tere Edastan DG HERA kirja. Vastamine käib esinduse kaudu. Komisjon palub nimetada kaks liiget mitteametlikku komisjoni MCM eksperdirühma - Informal Commission Expert Group on Medical Countermeasures (MCM) EUCI (EU Classified Information). Ekspertidel peab olema EL salajane juurdepääsuluba. Eksperdirühma eesmärk on toetada komisjoni EL tervisejulgeoleku tugevdamisel ning tervisehädaolukordadeks valmisoleku parandamisel. Rühm hindab ELi rahastatavate projektide ja hangete julgeolekuriske, sealhulgas tundliku teabe kaitset, võimalikke väärkasutusi ja MCM tarneahela haavatavusi. Lisaks aitab rühm välja töötada riskide vähendamise meetmeid ja julgeolekunõudeid ning toetab koostööd teadus-, arendus-, varumis- ja kaitsevaldkondade vahel. Palun andke hiljemalt 26.maiks teada, kelle nimetada võime. Koopiasse lisada [email protected] <mailto:[email protected]> . Tervitades Maret Maret Voore (Ms) Counsellor for Health Affairs Permanent Representation of Estonia to the EU +32 498 646 628 Rue Guimard 11/13 | 1040 Brussels <https://urldefense.com/v3/__http:/www.vm.ee/__;!!DOxrgLBm!CfLEIyb2GgJdD0bGIjEVgk2FNYC8lEoKqMN4GuZUX-2sXI8H245tLJ2e3-7mam8J-CQseorhFPl7VcW1EWxl01jFoUZKzLDrOGo$> eu.mfa.ee | <https://urldefense.com/v3/__https:/twitter.com/MFAestonia__;!!DOxrgLBm!CfLEIyb2GgJdD0bGIjEVgk2FNYC8lEoKqMN4GuZUX-2sXI8H245tLJ2e3-7mam8J-CQseorhFPl7VcW1EWxl01jFoUZKAaLyy1k$> @MFAestonia From: Katrin Juhandi <[email protected]> Sent: Monday, May 11, 2026 4:28 PM To: Maret Voore <[email protected]>; Agne Nettan-Sepp (SoM) <[email protected]> Cc: Katry Kivinurm <[email protected]> Subject: Fwd: Nomination request: Informal Commission Expert Group on Medical Countermeasures (MCM) and EUCI (EU Classified Information) ​ - Ares(2026)4767469 ---------- Forwarded message ---------- From: HERA EMERGENCY OFFICE <[email protected] <mailto:[email protected]> > Date: 11 May 2026 at 16:24:10 CEST Subject: Nomination request: Informal Commission Expert Group on Medical Countermeasures (MCM) and EUCI (EU Classified Information) ​ - Ares(2026)4767469 To: (BRE-GM) <[email protected] <mailto:[email protected]> >,(Bruksela UE - Sekretariat DPR) <[email protected] <mailto:[email protected]> >,(German Permanent Representation) <[email protected] <mailto:[email protected]> >,(Head of Mission of the Principality of Liechtenstein to the European Union) <[email protected] <mailto:[email protected]> >,(LT Perm Rep) <[email protected] <mailto:[email protected]> >,(LU Perm Rep) <[email protected] <mailto:[email protected]> >,(Perm Rep) <[email protected] <mailto:[email protected]> >,(Perm Rep) <[email protected] <mailto:[email protected]> >,(Permanent Representation of Croatia = Représentation permanente de la Croatie) <[email protected] <mailto:[email protected]> >,(Permanent Representation of Germany = Représentation permanente de l'Allemagne) <[email protected] <mailto:[email protected]> >,(Permanent Representation of Greece) <[email protected] <mailto:[email protected]> >,(Permanent Representative of Denmark) <[email protected] <mailto:[email protected]> >,(Permanent Representative of France) <[email protected] <mailto:[email protected]> >,(Republic of Cyprus - Ministry of Foreign Affairs) <[email protected]>,(Romanian Permanent Representation) <[email protected] <mailto:[email protected]> >,(Secretariat PermRep ES) <[email protected] <mailto:[email protected]> >,(permanent representation Latvia to the EU) <[email protected] <mailto:[email protected]> >,BRUESSEL-OV <[email protected] <mailto:[email protected]> >,BRUZILAS Robertas <[email protected] <mailto:[email protected]> >,CANAPARO Marco (Permanente Representation of Italy to the European Union) <[email protected] <mailto:[email protected]> >,CERNY Stepan (Permanent Representation of the Czech Republic = Représentation permanente de la République tchèque) <[email protected] <mailto:[email protected]> >,ESCALAS NOLLA Oriol (Permanent Representation of Spain = Représentation permanente d'Espagne) <[email protected] <mailto:[email protected]> >,[email protected] <[email protected] <mailto:[email protected]> >,HAUKUR JÓHANNESSON Stefán (Mission of Iceland to the EU = Mission de l'Islande auprès de l'UE) <[email protected] <mailto:[email protected]> >,HILTON Anne Camilla <[email protected] <mailto:[email protected]> >,HIRVONEN Lauri (Permanent Representation of Finland = Représentation permanente de la Finlande) <[email protected] <mailto:[email protected]> >,JAKOBSEN Soeren (Permanent Representation of Denmark = Représentation permanente du Danemark) <[email protected] <mailto:[email protected]> >,Katrin Juhandi <[email protected] <mailto:[email protected]> >,KNÚTSDÓTTIR Ásthildur (Mission of Iceland to the European Union = Mission de l'Islande auprès de l'UE) <[email protected] <mailto:[email protected]> >,MOLNAR Katalin (Permanent Representation of Hungary = Représentation permanente de la Hongrie) <[email protected] <mailto:[email protected]> >,[email protected] <[email protected] <mailto:[email protected]> >,MORAN Cait (psc ambassadors) <[email protected] <mailto:[email protected]> >,[email protected] <[email protected] <mailto:[email protected]> >,PIQUEMAL Cyril (REPRESENTATION PERMANENTE DE LA FRANCE AUPRES DE L'UE) <[email protected] <mailto:[email protected]> >,PLUCIŃSKI Arkadiusz (Permanent Representation of Poland = Représentation permanente de la Pologne) <[email protected] <mailto:[email protected]> >,SILVA Ana Isabel <[email protected] <mailto:[email protected]> >,TEIXEIRA PINTO Manuela <[email protected] <mailto:[email protected]> >,VERSMESSEN Bert (Permanent Representation of Belgium = Représentation permanente de la Belgique) <[email protected] <mailto:[email protected]> >,WEBBER Asa (Permanent Representation of Sweden = Représentation permanente de Suède) <[email protected] <mailto:[email protected]> >,WIRTENBERGER Franz <[email protected] <mailto:[email protected]> >,ZUMER Lidija (Permanent Representation of Slovenia = Représentation permanente de la Slovénie) <[email protected] <mailto:[email protected]> > Cc: (Health Attache FMB) <[email protected] <mailto:[email protected]> >,AOIFE Walker <[email protected] <mailto:[email protected]> >,BATARE Svetlana <[email protected] <mailto:[email protected]> >,BETZ Charles <[email protected] <mailto:[email protected]> >,BOERS Kris (Permanent Representation of Belgium = Représentation permanente de la Belgique) <[email protected] <mailto:[email protected]> >,BOYLE Dympna (Permanent Representation of Ireland = Représentation permanente de l'Irlande) <[email protected] <mailto:[email protected]> >,BRADLEY Emma (Permanent Representation of Ireland = Représentation permanente de l'Irlande) <[email protected] <mailto:[email protected]> >,CARBONELL Santiago (Reper España) <[email protected] <mailto:[email protected]> >,CHRYSANTHOU Isabelle (Cyprus Medical Devices Authority) <[email protected] <mailto:[email protected]> >,COURTNEY Éamonn (Permanent Representation of Ireland = Représentation permanente de l'Irlande) <[email protected] <mailto:[email protected]> >,DAMIGOU Aikaterini (Permanent Representation of Greece = Représentation permanente de la Grèce) <[email protected] <mailto:[email protected]> >,DE LASTELLE Marie (FRENCH GOVERNMENT) <[email protected] <mailto:[email protected]> >,DOBREVA Zlatimira (Permanent Representation of Bulgaria = Représentation permanente de la Bulgarie) <[email protected] <mailto:[email protected]> >,GEIL Kåre (Permanent Representation of Denmark = Représentation permanente du Danemark) <[email protected] <mailto:[email protected]> >,GEORGIOPOULOS Irene (Permanent Representation of France = Représentation permanente de la France) <[email protected] <mailto:[email protected]> >,GEORGIOU Loukas (MINISTRY OF HEALTH - MEDICAL AND PUBLIC HEALTH SERVICES) <[email protected] <mailto:[email protected]> >,GEORGIOU Maria (Permanent Representation of Cyprus = Représentation permanente de Chypre) <[email protected] <mailto:[email protected]> >,GROENEVELD Matthijs (Permanent Representation of Netherlands = Représentation permanente des Pays-Bas) <[email protected] <mailto:[email protected]> >,ICHAS Antoine (Permanent Representation of France = Représentation permanente de la France) <[email protected] <mailto:[email protected]> >,JAKAITIENE@URM Radvile <[email protected] <mailto:[email protected]> >,JELENA Talackiene <[email protected] <mailto:[email protected]> >,KARSAY Ákos (Permanent Representation of Hungary = Représentation permanente de la Hongrie) <[email protected] <mailto:[email protected]> >,KONARZEWSKA Karolina (Permanent Representation of Poland = Représentation permanente de la Pologne) <[email protected] <mailto:[email protected]> >,KORŽE Gabrijela (Permanent Representation of Slovenia = Représentation permanente de la Slovénie) <[email protected] <mailto:[email protected]> >,KOSSEBAU Sabine <[email protected] <mailto:[email protected]> >,KRALOVA Kristyna <[email protected] <mailto:[email protected]> >,KRIJN DE Veer <[email protected] <mailto:[email protected]> >,KUSOVAC Nikola (Permanent Representation of Croatia = Représentation permanente de la Croatie) <[email protected] <mailto:[email protected]> >,LENNON Eugene (Permanent Representation of Ireland = Représentation permanente de l'Irlande) <[email protected] <mailto:[email protected]> >,LUND Jeanette B (Permanent Representation of Sweden = Représentation permanente de Suède) <[email protected] <mailto:[email protected]> >,MALCORPS Jonathan <[email protected] <mailto:[email protected]> >,MERINO DE LA NUEZ Lucia (Representacion Permanente de España ante la Unión Europea) <[email protected] <mailto:[email protected]> >,MIFSUD Stephen M. <[email protected] <mailto:[email protected]> >,MILIN HORVAT Tanja (Permanent Representation of Croatia = Représentation permanente de la Croatie) <[email protected] <mailto:[email protected]> >,NIJHUIS Bas (Permanent Representation of Netherlands = Représentation permanente des Pays-Bas) <[email protected] <mailto:[email protected]> >,OLGA Fasbender <[email protected] <mailto:[email protected]> >,OTTO Claudine (Representation Permanente du Grand Duche du Luxembourg) <[email protected] <mailto:[email protected]> >,OVERBY SLOTH Simone (Permanent Representation of Denmark = Représentation permanente du Danemark) <[email protected] <mailto:[email protected]> >,PAVAO Francisco <[email protected] <mailto:[email protected]> >,PFEFFERLE Lea (Permanent Representation of Germany = Représentation permanente de l'Allemagne) <[email protected] <mailto:[email protected]> >,PIASECKA Ewa Magdalena (Permanent Representation of Poland = Représentation permanente de la Pologne) <[email protected] <mailto:[email protected]> >,POROSINA Irina (Veselības ministrijas = Ministry of health) <[email protected] <mailto:[email protected]> >,REST Vinzent (Permanent Representation of Austria = Représentation permanente de l'Autriche) <[email protected] <mailto:[email protected]> >,SAMARAS Ilias (Permanent Representation of Greece to the EU) <[email protected] <mailto:[email protected]> >,[email protected] <[email protected] <mailto:[email protected]> >,SCHNEIDER Eric <[email protected] <mailto:[email protected]> >,SIMONETTI Pasquale (Ministero della Salute = Ministry for Health) <[email protected] <mailto:[email protected]> >,SLOBODNIK Miha (Ministrstvo za kmetijstvo, gozdarstvo in prehrano = Ministry of Agriculture, Forestry and Food) <[email protected] <mailto:[email protected]> >,SOLÁROVÁ Nikol (Permanent Representation of Slovakia = Représentation permanente de la Slovaquie) <[email protected] <mailto:[email protected]> >,STAICU Stefan (Permanent Representation of Romania = Représentation permanente de la Roumanie) <[email protected] <mailto:[email protected]> >,TEROL GARCIA Enrique (Permanent Representation of Spain = Représentation permanente d'Espagne) <[email protected] <mailto:[email protected]> >,TZOANNOPOULOS Konstantinos (Permanent Representation of Greece = Représentation permanente de la Grèce) <[email protected] <mailto:[email protected]> >,VANDEWALLE Sandra (Permanent Representation of Austria = Représentation permanente de l'Autriche) <[email protected] <mailto:[email protected]> >,Maret Voore <[email protected] <mailto:[email protected]> >,VUORINEN Sari (Maa- ja metsätalousministeriö = Ministry of Agriculture and Forestry) <[email protected] <mailto:[email protected]> >,WENNERSTRAND Sofia (REGERINGSKANSLIET = Government Offices of Sweden) <[email protected] <mailto:[email protected]> > EUROPEAN COMMISSION HEALTH EMERGENCY PREPAREDNESS AND RESPONSE AUTHORITY The Director-General Brussels HERA.01/SD Permanent Representations of EU Member States and Missions of EEA/EFTA countries to the EU Subject: Nomination request: Informal Commission Expert Group on Medical Countermeasures (MCM) EUCI (EU Classified Information) Dear Sir/Madam, With the present we would like to ask you to identify experts from your Administration (1) who will support the Commission with technical, security advice and expertise in the area of health emergency preparedness and medical countermeasures. The proposed experts will be formally nominated as members of the MCM EUCI Informal Commission Expert Group. This group will contribute to the implementation of the MCM Strategy2 and will play in particular a crucial role in enhancing capabilities by overseeing all aspects of MCM security, from research and development to procurement and supply chain logistics, ensuring the protection of sensitive information, in synergy with existing structures. Their inputs are not binding on the Commission which remains fully independent concerning whether it consults the experts and the way it considers the expertise and views gathered. The group is established on a permanent basis, pursuant to Commission Decision C(2016) 3301, for unlimited duration. It will serve as the pool from which the Commission will draw experts to carry out security scrutiny assessments whenever warranted in the framework of their activities. We kindly request that EU Member States and European Economic Area (EEA)/ European Free Trade Association (EFTA) Countries which have a Security of (1) Please refer to the Terms of Reference for detailed expert profiles and sectoral requirements. For further inquiries, please contact HERA. (2) Commission has launched, in July 2025, the EU Medical Countermeasures Strategy, which sets out new measures on dual-use MCMs beyond research and innovation, including the procurement of products with civil–military potential and the preparation of a shortlist of essential medical countermeasures for armed aggression Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË – Tel. +32 22991111 Information Agreement in force with the EU nominate permanent representatives to the group. This, of course, would not prevent Member States and Associated Countries to possibly replace nominated experts throughout the period or add additional experts, as appropriate. Role of the experts The expert group will be charged with advising the Commission in view of aligning strategic security measures with the European Union’s health preparedness/response objectives. It will conduct detailed security reviews for EU-funded actions, assisting in the screening of proposals for EU grants, tenders, and other funding or procurement agreements under EU4Health or other programmes, with a focus on developing security and risk mitigation measures concerning sensitive and classified information, thereby supporting the programme’s evolution and reinforcing health security. Additionally, the group will provide technical and security feedback, fostering collaboration on EU-level initiatives across the full MCM research, development and market pipeline, including intelligence and stockpiling/capacity reservation actions beyond direct EU funding. The group will also engage in future tasks intersecting with military and defence sectors. In particular, the nominated experts will support the Commission with the evaluation of possible security issues in public health emergency preparedness and medical countermeasures, with the aim to: • Identify and address security concerns such as: − potential misuse of results (e.g., dual-use risks, unauthorised exploitation, or malicious applications); − vulnerabilities in the MCM value chain (e.g., research, development, procurement, stockpiling, or deployment); − gaps in intelligence-sharing or coordination that could undermine health security; and propose targeted mitigation measures to neutralise these risks. • Ensure compliance with EU security rules, with a focus on: − protecting sensitive non-classified (SNC) and EU classified information (EUCI) from unauthorised disclosure, cyber threats or espionage; − translating security requirements into enforceable obligations, including binding contractual clauses in grants, tenders, procurement agreements, or other funding instruments under EU4Health or related programmes, particularly for actions involving classified data or high-risk MCM initiatives. In reference to the EU4Health work programme, the experts will be formally responsible for scrutinising, from a security perspective only, proposals involving beneficiaries from their own Member State/Country. The nominated experts should actively participate and should remain involved in the whole process, from drafting individual security reports to participate in consensus meetings. Following this nomination, and in relation to the ongoing evaluation of the call “CP-g-25-01 – Call for proposals to support the 2 development of innovative medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) threats (3)” we will be directly contacting the designated experts from the applicants’ respective countries. These experts will be entrusted with conducting the security scrutiny of proposals potentially selected for funding. Additionally, they will be furnished with detailed information regarding their tasks and the timeline for the security assessment. Number of experts to nominate To facilitate the process, Members shall nominate two representatives on a permanent basis, who shall: • provide high level expertise in the security domains related to public health, MCM research, development and/or deployment, industry, or civil-military affairs; • hold a valid Personnel Security Clearance (PSC) at the SECRET UE/EU SECRET level or an equivalent national security clearance, authorising them to access EUCI up to this level. Nominated experts are subject to the obligation of professional secrecy which, by virtue of the Treaties and the rules implementing them, applies to all members of the institutions and their staff, as well as to the Commission's rules on security regarding the protection of Union classified information, laid down in Commission Decisions (EU, Euratom) 2015/443 (4) and 2015/444 (5). The workload of the MCM EUCI Informal Commission Expert Group may extend as DG HERA’s activities evolved requiring Member States’ and Associated Countries’ technical and security feedback (e.g. on EU-level stockpiling of MCMs), secure information exchange in relation to MCM preparedness and response, military and defence coordination. Process of nomination The formal nomination letter should be signed by both the nominating Authority and the relevant National Security Authority (NSA) or Designated Security Authority (DSA). In cases where the NSA/DSA’s signature cannot be obtained, the letter must include a formal declaration confirming that: (i) the nominating authority has consulted the NSA/DSA, and (ii) the NSA/DSA has explicitly agreed to the nomination. (3) https://hadea.ec.europa.eu/news/2025-eu4health-calls-proposals-crisis-preparedness-2025-09-04_en (4) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41). (5) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). 3 The nominations should be done formally by email via a letter that is to be sent to DG HERA via [email protected] and addressed to the European Commission, more specifically to DG HERA Director-General Thank you very much for your collaboration, and we’re looking forward to receiving the nomination letter for the new experts by 29 May 2026 at the latest. Yours faithfully, (Electronically signed) Florika FINK‑HOOIJER Enclosure: Terms of reference (ToR) of the MCM EUCI Informal Commission Expert Group c.c.: Health Attachés MUSCHEL Laurent, SCHILLING Johannes, WILLIAMSON Clément, SIMON Anne, GIRARD Olivier, BURGOS GUTIERREZ, Ana VON BUXHOEVEDEN Daphne 4 Electronically signed on 11/05/2026 15:01 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121 EUROPEAN COMMISSION HEALTH EMERGENCY PREPAREDNESS AND RESPONSE AUTHORITY INFORMAL COMMISSION EXPERT GROUP ON MEDICAL COUNTERMEASURES (MCM) EU CLASSIFIED INFORMATION (EUCI) TERMS OF REFERENCE 1. BACKGROUND In 2021, the European Union established the EU4Health Programme1 to complement the human health policies of EU Member States, including by improving the availability, accessibility and affordability of medical countermeasures (MCM) in the Union, and supporting innovation regarding such products. Under this objective, the Commission has recently reinforced its commitment to developing novel medical countermeasures (MCM) against chemical, biological, radiological and nuclear (CBRN) threats in light of the evolving geopolitical and security risks. That is why, under the EU4Health 2025 Work Programme2, the Commission’s Health Emergency Preparedness and Response Authority (‘DG HERA’) provided for a dedicated action3 to support the development and deployment of new medicinal products, diagnostics, and personal protective equipment to address CBRN-related challenges. Unlike the Horizon Europe Regulation4, which establishes comprehensive security provisions applicable to all actions under the Commission’s research and innovation programme, other funding instruments, such as EU4Health, do not include specific provisions in their basic acts governing the handling of projects that raise comparable security-related concerns. Therefore, and in line with Commission Decision (EU, Euratom) 2015/4445, it is now necessary to establish a dedicated expert group to assist the Commission with a view to ensuring that actions implemented outside Horizon Europe are subject to similar security standards. Furthermore, the Commission adopted in July 2025, the EU Medical Countermeasures Strategy6, which sets out new initiatives on MCMs for dual purposes beyond research and 1 Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 2 Commission Implementing Decision (C(2025) 5148 final) on the financing of the programme for the Union´s action in the field of health (‘EU4Health programme’) and the adoption of the work programme for 2025 3 “CP-g-25-01 – Call for proposals to support innovative medical countermeasures for CBRN threats” 4 Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 5 Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU Classified Information 6 COM(2025) 529 final 1 innovation, including on the procurement of MCM products with civil–military potential and the preparation of a shortlist of essential medical countermeasures for armed aggression. Considering the Commission’s expanding scope of activities related to MCM that may involve EU classified information (EUCI), this expert group will support the Commission in ensuring a robust security framework across the full MCM life cycle, including intelligence, research and innovation, manufacturing, procurement, stockpiling and market deployment. This expert group is expected to operate for unlimited duration. 2. SUBJECT MATTER The group of experts on ‘Medical Countermeasures EU Classified Information’ (‘the group’) is set up. 3. TASKS The group’s tasks shall be: 1) to assist the Commission7 in strengthening the security framework for the entire MCM value chain, which will ensure the safeguarding of Sensitive Non-Classified Information (SNC) and EU classified information (EUCI) throughout intelligence sharing, research and innovation, manufacturing, procurement, and logistics actions; 2) in the framework of the EU MCM Strategy, to assist the Commission in enhancing its capabilities, in synergy with other existing structures, in all security dimensions of MCM development and deployment; 3) to provide security guidance to the Commission regarding its efforts and initiatives to guarantee the availability and accessibility of MCM, such as the identification, assessment, and prioritisation of threats to health, as well as the development and deployment of MCM; 4) to provide the Commission with opinions on security aspects related to the coordination and cooperation with Member States and other relevant stakeholders on questions relating to the implementation of Union legislation, programmes and policies in the field of MCM for public health emergency preparedness and response; 5) to support exchange of security good practices and experiences regarding MCM, including dual-use MCM, development and deployment across the different sectors (e.g. civil, military, industrial, among others). 7 Such as DG SANTE, DG ECHO, DG DEFIS, DG HOME or DG RTD. 2 4. CONSULTATION The Commission may consult the group on any matter relating to: 1. Conducting security scrutiny assessments: o for proposals for grants, tenders, or other implementation instruments under the EU4Health or other programmes for MCM and public health emergency preparedness and response-related actions, including advising on specific security and risk mitigation measures in relation to classified information and/or projects’ results. o of private sector companies involved in, or set to be involved, in the implementation of EU-funded MCM initiatives (such as joint or central procurement or stockpiling actions, capacity reservation projects, or specific flagships, such as the RAMP UP8 initiative), or any other companies critical in the MCM value chain, such as actors involved in the development, production, or supply of MCM. 2. Providing, where needed, a resource pool of security authorities from which the Commission can draw experts to support specific activities within the scope of the group’s tasks, including (apart from the security scrutiny assessment referred in point 1) security sensitive projects’ monitoring and follow-up or pre-emptive consideration of security provisions in new initiatives. 3. Facilitating the secure exchange of information: o related to national and EU level procurement, capacity reservation, and stockpiling of MCM; o related to the Commission’s ‘Health Threat Prioritisation Assessment for Medical Countermeasures’ and other MCM-related preparedness measures at Member State and EU levels; o on Member State response plans for serious cross-border threats to health, including CBRN and civil-military cooperation for public health emergency preparedness and response; o on MCM-related projects funded by Member States or by the Union, enabling data sharing and secure systems interoperability; o among Member States and the EU institutions and agencies on the availability and accessibility of MCM, including on supply chain and other dependencies’ risks; 4. Informing and collaborating on MCM EU-level initiatives that may involve security risks, including any preparatory work (e.g. pipeline or market analysis). 8 Rapid Agile Manufacturing Partnerships for Union Protection, to be launched by DG HERA under the EU MCM Strategy 3 5. MEMBERSHIP 1. Members shall be Member States’ authorities and national authorities from EEA/EFTA countries which have Security of Information Agreement with the EU. 2. Members shall nominate two representatives on a permanent basis, who shall: • provide high level expertise in the security domains related to public health, MCM research, development and/or deployment, industry, or civil-military affairs; • hold a valid Personnel Security Clearance (PSC) at the SECRET UE/EU SECRET level or an equivalent national security clearance, authorising them to access EUCI up to this level. 3. Members may replace nominated representatives at their own initiative, or at the request of the Chair, if the Chair considers that representatives do no longer meet the criteria referred to in paragraph 2. 6. CHAIR 1. The group shall be chaired by a representative of DG HERA. 2. DG HERA may delegate the chairing of the group to a representative of another Commission service when the group is requested to support or advise that service. 7. OPERATION 1. The group shall act at the request of the Commisison, in compliance with the Commission’s horizontal rules on expert groups9 (‘the horizontal rules’). 2. Meetings of the group shall, in principle, be held on Commission premises or virtually depending on the circumstances. When required, meetings shall be held in a secured environment. 3. DG HERA shall provide secretarial services. When acting at the request of another Commission service, it shall do so with the support of that service. Commission officials and other servants from departments with an interest in the discussions or the issues, and holding (when required) an appropriate PSC, may also attend meetings of the group. 4. Minutes on the discussion on each point on the agenda and on the opinions delivered by the group shall be meaningful and complete. Minutes shall be drafted by the secretariat under the responsibility of the Chair. 5. As far as possible, the group shall adopt its opinions, recommendations, or reports by consensus. In the event of a vote, the outcome of the vote shall be decided by simple majority of the members. Members who have voted against or abstained shall have the right to have a document summarising the reasons for their position annexed to the opinions, recommendations, or reports. 9 C(2016) 3301, Article 13.1. 4 6. Appropriate communication and information systems (CIS) and encryption tools will be employed for the exchange and storage of SNC and EUCI. 7. Subject to the Chair's approval, deliberations on non-classified and non-sensitive matters may be made public. Conversely, for sensitive or classified topics, deliberations will be handled securely. 8. SUB-GROUPS DG HERA may set up sub-groups for the purpose of examining specific questions on the basis of terms of reference defined by DG HERA. Sub-groups shall operate in compliance with the horizontal rules and shall report to the group. They shall be dissolved as soon as their mandate is fulfilled. 9. INVITED EXPERTS 1. DG HERA may invite experts with specific expertise with respect to subject matters on the agenda to take part in the work of the group on an ad hoc basis. These could be e.g. representatives of professional or scientific bodies or non-governmental organisations with recognised experience in disciplines related to their work, to cooperate in specific tasks and to take part in the relevant activities of the group. 2. Unless duly justified, such experts or representatives should hold a valid PSC at the SECRET UE/EU SECRET level or possess an equivalent national security clearance. 10. OBSERVERS 1. Individuals, organisations and public authorities other than Member States’ authorities and national authorities from EEA/EFTA countries referred to under Point 5 may be granted an observer status, in compliance with the horizontal rules, by direct invitation. 2. Organisations and public authorities appointed as observers shall nominate their representatives. Representatives may be asked to hold a valid PSC at the SECRET UE/EU SECRET level or possess an equivalent national security clearance, authorising them to access EUCI up to this level. 3. Observers and observers’ representatives may be permitted by the Chair to take part in the discussions of the group and its sub-groups and provide expertise. However, they shall not have voting rights and shall not participate in the formulation of recommendations or advice of the group or its sub-groups. 11. RULES OF PROCEDURE On a proposal by and in agreement with DG HERA, the group shall adopt its rules of procedure by simple majority of its members, on the basis of the standard rules of procedure 5 for expert groups, in compliance with the horizontal rules10. Sub-groups shall operate in compliance with the group’s rules of procedure. 12. PROFESSIONAL SECRECY AND HANDLING OF CLASSIFIED INFORMATION The members of the group and their representatives, as well as invited experts and observers, are subject to the obligation of professional secrecy, which by virtue of the Treaties and the rules implementing them applies to all members of the institutions and their staff, as well as to the Commission's rules on security regarding the protection of Union classified information, laid down in Commission Decisions (EU, Euratom) 2015/44311 and 2015/44412. Should they fail to respect these obligations, the Commission may take all appropriate measures. 13. TRANSPARENCY 1. The group and its sub-groups shall be registered in the Register of Commission expert groups and other similar entities (‘the Register of expert groups’). 2. As regards the group and sub-groups composition, the following data shall be published on the Register of expert groups: • the name of Member States' authorities; • the name of third countries’ authorities; • the name of observers. 3. All relevant, non-sensitive or non-classified documents, including the agendas, the minutes and the participants’ submissions, shall be made available on the Register of expert groups. In particular, DG HERA shall publish the agenda and other relevant non-classified and non-sensitive background documents in due time ahead of the meeting, followed by timely publication of minutes. Exceptions to publication shall only be possible where it is deemed that disclosure of a document would undermine the protection of a public or private interest as defined in Article 4 of Regulation (EC) N° 1049/200113. Documents containing SNC or EUCI shall be communicated to the group members using appropriate communication and information systems (CIS) and encryption tools. 10 See Article 17 of the horizontal rules. 11 Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41). 12 Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). 13 These exceptions are intended to protect public security, military affairs, international relations, financial, monetary or economic policy, privacy and integrity of the individual, commercial interests, court proceedings and legal advice, inspections/investigations/audits and the institution's decision- making process. 6 14. MEETING EXPENSES 1. Participants in the activities of the group and sub-groups shall not be remunerated for the services they offer. 2. Travel and subsistence expenses incurred by participants in the activities of the group and subgroups shall be reimbursed by the Commission. Reimbursement shall be made in accordance with the provisions in force within the Commission14 and within the limits of the available appropriations allocated to the Commission departments under the annual procedure for the allocation of resources. Done in Brussels, on 6 May 2026. 14 Commission Decision C(2007)5858 7
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