Nimetamine ekspertgruppi

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË – Tel. +32 22991111

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

2

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

3

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).

4

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

Electronically signed on 11/05/2026 15:01 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121

1

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

2

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.

3

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

4

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.

5

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

6

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.

7

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

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË – Tel. +32 22991111

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

2

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

3

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).

4

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

Electronically signed on 11/05/2026 15:01 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121

1

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

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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.

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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

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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.

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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

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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.

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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