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Annex I List of Joint Actions_WP 2024_140324.pdf

ANNEX I

GUIDANCE FOR NOMINATION AND LIST OF JOINT ACTIONS AND

INDICATIVE TIMELINES

Guidance for nomination

The submission of the competent authorities and affiliated entities nominations per Joint

Action shall be done through the EU Survey website following this link:

https://ec.europa.eu/eusurvey/runner/EU4HEALTH_JA2024

The password is: 2024JA#

The reference to “Member States’ authorities” means “competent authorities responsible for health

in the Member States and in third countries associated to the EU4Health programme”.

List of Joint Actions and specific deadlines (per wave)

1st wave - deadline for the nomination is 25 April 2024

• EU4H-2024-JA-IBA-01- Direct grants to Member States’ authorities: Support to the

development of sustainable, forward-looking national and Union stockpiling strategies

(HERA) (CP-g-24-13) - EUR 10 000 000 EU co-funding

Indicative timeline for proposal submission (1st wave)

Opening submission date: 23 May 2024

Submission deadline: 5 September 2024

2nd wave - deadline for the nomination is 21 May 2024

• EU4H-2024-JA-IBA-02 - Direct grants to Member States’ authorities: Strengthening digital

capabilities including e-health, telemedicine, remote monitoring systems, health data access

and health data exchange services in cancer centres in the Union (CR-g-24-36) - EUR 20

000 000 EU co-funding

• EU4H-2024-JA-IBA-03 - Direct grants to Member States’ authorities: to support quality

improvement of cancer registry data feeding the European Cancer Information System (CR-

g-24-40) - EUR 13 000 000 EU co-funding

Indicative timeline for proposal submission (2nd wave)

Opening submission date: 18 June 2024

Submission deadline: 10 October 2024

3rd wave - deadline for the nomination is 23 July 2024

• EU4H-2024-JA-IBA-04 - Direct grants to Member States’ authorities: Cancers caused by infections, vaccine-preventable cancers and addressing communicable diseases (HIV/AIDS, Tuberculosis, Hepatitis) (DP/CR-g-24-28) - EUR 20 000 000 EU co-funding

• EU4H-2024-JA-IBA-05 - Direct grants to Member States’ authorities: Personalised Cancer

Medicine (CR-g-24-41) - EUR 27 900 000 EU co-funding

• EU4H-2024-JA-IBA-06 - Direct grants to Member States’ authorities: Promoting a comprehensive, prevention-oriented approach to mental health to support vulnerable groups (DP-g-24-24) - EUR 6 000 000 EU co-funding

• EU4H-2024-JA-IBA-07 - Direct grants to Member States’ authorities: Health promotion and disease prevention including smoke- and aerosol- free environments (DP/CR-g-24-27)- EUR 16 000 000 EU co-funding

• EU4H-2024-JA-IBA-08 - Direct grants to Member States’ authorities: supporting National

Focal Points (‘NFPs’) in providing guidance, information and assistance related to the promotion and implementation of the EU4Health Programme and other relevant legislation (DP-g-24-34) - EUR 2 000 000 EU co-funding

• EU4H-2024-JA-IBA-09 - Direct grants to Member States’ authorities: Paediatric palliative care (CR-g-24-44) - EUR 14 500 000 EU co-funding

• EU4H-2024-JA-IBA-10 - Direct grants to Member States’ authorities: Pricing and Reimbursement Authorities – to step up national work and collaboration in the group of National Competent Authorities on Pricing and Reimbursement and Public Healthcare Payers (‘NCAPR’) (HS-g-24-54) - EUR 2 000 000 EU co-funding

• EU4H-2024-JA-IBA-11- Direct grants to Member States’ authorities: Effective use of

regulatory flexibilities including the use of magistral preparations that might be used to mitigate certain shortages (HS-g-24-104) - EUR 2 000 000 EU co-funding

Indicative timeline for proposal submission (3rd wave)

Opening submission date: 17 September 2024

Submission deadline: 22 January 2025

Annex III Eligibility Criteria for nominated CAs_WP 2024_140324.pdf

EUROPEAN COMMISSION EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA)

ANNEX III:

ELIGIBILITY CRITERIA AND NOMINATION OF COMPETENT AUTHORITIES

1. INTRODUCTION: WHAT IS A DIRECT GRANT CO-FINANCED WITH COMPETENT

AUTHORITIES OF MEMBER STATES (JOINT ACTIONS) UNDER THE EU4HEALTH

PROGRAMME

A Joint Action (JA) is a direct grant consisting in collaborative action among Member States

and associated countries participating in the EU4Health Programme, inter alia, to develop,

share, refine and test tools, methods and approaches to specific health issues, and engage in

capacity building in key areas of interest.

2. CRITERIA FOR FINANCIAL CONTRIBUTION FROM THE UNION BUDGET FOR JOINT

ACTIONS

Joint Action grants may be awarded without calls for proposals1.

The Joint Actions will take into account the outcomes of past actions funded by the Health

Programmes on similar topics and of ongoing negotiations of a legislative nature.

A Joint Action will involve co-financing by the Union, at the rates defined in Art. 8 (3) of the

EU4Health Programme Regulation2.

In line with Article 13(5) of the EU4Health Programme Regulation and the relevant annual

work programme, Joint Actions will be co-financed by:

• competent authorities responsible for health in the Member States or in third countries

associated to the Programme; or

• public sector bodies or non-governmental bodies that are mandated by those

competent authorities, regardless of whether those bodies act individually or as a

network.

1 Article 195(d) of the Regulation (EU, Euratom) 2018/104 (Financial Regulation) and Article 13(5) of

Regulation (EU) 2021/522.

2 Regulation (EU) 2021/522 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.

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

2

Eligibility, selection and award criteria

Eligible legal entities

Under Article 13(5) of the Programme regulation, direct grants may be awarded without a call

for proposals to fund actions:

- if such grants are duly justified, and

- if those actions have a Union added value that is explicitly provided for in the annual

work programmes, and

- are co-financed by the competent authorities that are responsible for health in the Member

States or in third countries associated to the Programme, or by public sector bodies or

non-governmental bodies that are mandated by those competent authorities, regardless of

whether those bodies act individually or as a network.

Member States’ or associated countries’ responsible authorities receiving the invitation are

invited to nominate one or more competent authority(ies)3 responsible for implementing the

action on their behalf. The nomination should confirm that:

• the nominated entity(ies) will be acting as competent authority(ies) for the given action;

and

• the nominated entity(ies) and their affiliated entities4 are the eligible legal entities to

participate in the action on behalf of the country concerned and under its

responsibility.

Applicants’ selection criteria

• financial capacity – applicants must have stable and sufficient sources of funding to

maintain their activity throughout the duration of the grant and to participate in its

co-financing5; and

• operational capacity – applicants must have sufficient operational and professional

capacities to implement the activities and complete the proposed action.

3 Nominated competent authorities may be one of the following: a Member State’s or associated country’s

authority responsible for health, a relevant international health organisations or public sector bodies or non-

governmental bodies that are mandated by those competent authorities, regardless of whether those bodies

act individually or as a network.

4 ‘Affiliated entities’ are entities that satisfy the eligibility criteria, do not fall within one of the situations

referred to in Articles 136(1) and 141(1) of the Financial Regulation and have a link with the beneficiary, in

particular a legal or capital link, which is neither limited to the action nor established for the sole purpose of

its implementation.

5 The financial capacity of public bodies and international organisations will not be subject to verification.

3

Proposals award criteria

Proposals will be assessed based on the following award criteria:

a) Relevance: clarity and consistency of project, objectives and planning; extent to

which they match the themes and priorities and objectives of the call; contribution to

the EU strategic and legislative context; European/trans-national dimension;

impact/interest for a number of countries (EU or eligible non-EU countries);

possibility to use the results in other countries; potential to develop mutual trust/cross-

border cooperation (30 points)

b) Quality:

- Project design and implementation: technical quality; logical links between the

identified problems, needs and solutions proposed (logical frame concept);

methodology for implementing the project (concept and methodology,

management, procedures, timetable, risks and risk management, monitoring and

evaluation); feasibility of the project within the proposed time frame; cost

effectiveness (sufficient/appropriate budget for proper implementation; best value

for money) (30 points)

- Project team and cooperation arrangements: quality of the consortium and project

teams; appropriate procedures and problem-solving mechanisms for cooperating

within the project teams and consortium (30 points)

c) Impact: ambition and expected long-term impact of results on target groups/general

public; appropriate dissemination strategy for ensuring sustainability and long-term

impact; sustainability of results after EU funding ends (10 points).

3. ROLE OF THE NOMINATED COMPETENT AUTHORITIES

Each country participating in the EU4Health Programme is invited to nominate one or more

competent authority(ies), which will become the grant beneficiary(ies) and be responsible for

the implementation of the action on its behalf.

The competent authority(ies) manage and carry out the action together with the coordinator

(lead competent authority for the action) contributing with their own funding and ensuring

that the objectives of the action are met.

The nominated competent authority(ies) may involve in the grant under their responsibility

other participants, such as affiliated entities and subcontractors. Their names shall be

indicated by the competent authorities when submitting the proposal, together with the

activities they will perform.

4

3.1. Affiliated entities

Affiliated entities are formally established organisations, defined as: "entities that satisfy the

eligibility criteria and that do not fall within one of the exclusion situations6 and that have a

link with the beneficiary, in particular a legal or capital link, which is neither limited to the

action nor established for the sole purpose of its implementation"7.

Affiliated entities must fulfil the same conditions for participation and funding as

beneficiaries. Complies with the eligibility and non-exclusion criteria applying to

applicants, specifically, does not fall within one of the situations referred to in Articles

136(1) and 141(1) of the Financial Regulation.

Condition for affiliation. Affiliated entities are entities with a legal link to the

beneficiaries which implement parts of the action and are allowed to charge costs directly to

the grant.

‘Legal link to the beneficiaries’ means a legal or capital link, which is neither limited to the

action nor established for the sole purpose of its implementation. This covers:

• permanent legal structures (e.g., the relationship between an association and its members)

• contractual cooperation not limited to the action (e.g., a collaboration agreement for

research in a particular field)

• capital link. i.e., − direct or indirect control of the

beneficiary.

In the public sphere, affiliated entities cover:

• The different levels of the administrative structure in case of decentralised

administration (e.g. national, regional or local administrations), or/and

• Public sector bodies (e.g. national institutes or schools for public health or national

research centres) which and are (at least in part) publically funded to deliver a public or

government service, or are in situation of control by a state organization/other public

body.

What is not an affiliated entity?

• Entities that have entered into a (procurement) contract or subcontract with the

competent authority (beneficiary), or who act as concessionaires or delegates for public

services for the beneficiary.

• Entities that cooperate with the beneficiary on the basis of a memorandum of

understanding or share some assets.

While affiliated entities do not sign the grant agreement, they actively contribute to the

implementation of the action. Costs incurred by such entities for implementing the action will

be accepted as eligible costs. Affiliated entities do not have direct access to the Funding &

Tenders Portal, this is done via their beneficiaries.

6 Referred in Articles 136 (1) and 141 (1) of the Financial Regulation. 7 Article 187 of the Financial Regulation 2018/1046.

5

3.2. Subcontractors

These are entities subcontracted by the nominated competent authorities for the purpose of

providing special expertise to the action. It should be noted that coordination and other

essential tasks cannot be subcontracted.

Subcontracting must comply with the rules in force regarding public procurement, as

applicable.

4. ELIGIBILITY CHECKS

After the submission deadline, nominations will be verified to ensure that the eligibility

criteria are fulfilled.

The European Health and Digital Executive Agency (HaDEA) reserves its right to assess the

regularity of the nomination procedure and to carry out checks. During this process, HaDEA

may request supporting documents, such as legal act establishing the nominated organisation.

5. SUBMISSION OF NOMINATIONS VIA EU SURVEY WEBSITE

The submission of the competent authority(ies) nominations per action under the EU4Health

Programme 2024 shall be done through the EU Survey website following this link:

https://ec.europa.eu/eusurvey/runner/EU4HEALTH_JA2024

The password is: 2024JA#

The instructions and the form are available on EU Survey website.

There are two steps to follow:

Step 1 - Instructions and completion of the nomination form:

The editable .pdf template of the nomination form should be downloaded, completed, printed

and signed by the nominating authority, in general by the Ministry of Health or Health Board.

The editable .pdf template has a limited number of characters; all filled fields should be

visible and readable before signature.

Step 2 - Submission of the nomination form:

In this step, you should complete a short online registration form consistently with the

completed .pdf nomination form. Upload the scanned signed version of the latter and submit

the nomination.

In case you need assistance, please contact: [email protected]

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6. PRIVACY AND DATA PROTECTION POLICY

Participation in the Joint Action will involve the collection, use and processing of personal

data (such as name, address and CV). This data will be processed in accordance with

Regulation No 2018/17258. It will be processed by HaDEA solely for the purpose of

evaluating the proposal and subsequent management of the grant (e.g. list of participants of

the Joint Action and share data among those participants) and, if needed, programme

monitoring, evaluation and communication with DG Health and Food Safety, National Focal

Points. Details are available on HaDEA Data Protection (europa.eu) page.

8 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the

protection of personal data by the European Union's institutions and bodies and on the free movement of

such data.

E-kiri.eml

Tere!

Igaks juhuks edastan ka SoM üldaadressile.

Heade soovidega

Tiiu Noobel

Sekretär

Eesti Vabariigi alaline esindus EL juures

Rue Guimard 11/13, 1040 Brüssel

Tel: + 32 2227 4337, tiiu.noobel@mfa.ee

https://eu.mfa.ee/et/

From: [email protected] <[email protected]>
Sent: Wednesday, July 17, 2024 7:14 PM
Cc: [email protected]; [email protected]
Subject: Gentle reminder - 23 July - DDL : nomination of the entities participating to the JAs 3rd wave and other Direct Grants under the EU4H AWP2024

Dear Health attachés and representatives of the Member States and EU4Health Associated Countries,

Please be reminded of the 23 July 2024 deadline to nominate competent authorities for the 3^rd wave of Joint actions and other Direct Grants under the EU4H AWP2024. Below the list of actions concerned:

Joint Actions 3rd wave

• EU4H-2024-JA-IBA-04 - Direct grants to Member States’ authorities: Cancers caused by infections, vaccine-preventable cancers and addressing communicable diseases (HIV/AIDS, Tuberculosis, Hepatitis) (DP/CR-g-24-28) - EUR 20 000 000 EU co-funding

• EU4H-2024-JA-IBA-05 - Direct grants to Member States’ authorities: Personalised Cancer Medicine (CR-g-24-41) - EUR 27 900 000 EU co-funding

• EU4H-2024-JA-IBA-06 - Direct grants to Member States’ authorities: Promoting a comprehensive, prevention-oriented approach to mental health to support vulnerable groups (DP-g-24-24) - EUR 6 000 000 EU co-funding

• EU4H-2024-JA-IBA-07 - Direct grants to Member States’ authorities: Health promotion and disease prevention including smoke- and aerosol- free environments (DP/CR-g-24-27)- EUR 16 000 000 EU co-funding

• EU4H-2024-JA-IBA-08 - Direct grants to Member States’ authorities: supporting National Focal Points (‘NFPs’) in providing guidance, information and assistance related to the promotion and implementation of the EU4Health Programme and other relevant legislation (DP-g-24-34) - EUR 2 000 000 EU co-funding

• EU4H-2024-JA-IBA-09 - Direct grants to Member States’ authorities: Paediatric palliative care (CR-g-24-44) - EUR 14 500 000 EU co-funding

• EU4H-2024-JA-IBA-10 - Direct grants to Member States’ authorities: Pricing and Reimbursement Authorities – to step up national work and collaboration in the group of National Competent Authorities on Pricing and Reimbursement and Public Healthcare Payers (‘NCAPR’) (HS-g-24-54) - EUR 2 000 000 EU co-funding

• EU4H-2024-JA-IBA-11- Direct grants to Member States’ authorities: Effective use of regulatory flexibilities including the use of magistral preparations that might be used to mitigate certain shortages (HS-g-24-104) - EUR 2 000 000 EU co-funding

Direct Grants

• EU4H-2024-DGA-MS-IBA-01 - Direct grants to Member States’ authorities: Expansion of MyHealth@EU (DI-g-24-75) - EUR 7 000 000 EU co-funding

We thank you in advance for your contribution and any requests for further clarifications should be addressed to [email protected].

Best regards,

EU4Health Programme Secretariat