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Ref. Ares(2024)2183327 - 22/03/2024 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 Saatja: "Tiiu Noobel" <[email protected]> Saaja: "SM Info" Teema: FW: Gentle reminder - 23 July - DDL : nomination of the entities participating to the JAs 3rd wave and other Direct Grants under the EU4H AWP2024 Kuupäev: 2024-07-18 07:20 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, <mailto:[email protected]> [email protected] <https://eu.mfa.ee/et/> 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 3rd 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 <mailto:[email protected]> [email protected]. Best regards, EU4Health Programme Secretariat Ref. Ares(2024)2183327 - 22/03/2024 EUROPEAN COMMISSION EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA) ANNEX III: ELIGIBILITY CRITERIA AND NOMINATION OF COMPETENT AUTHORITIES 1. INTRODUCTION: DIRECT GRANT CO-FINANCED WITH COMPETENT WHAT IS A 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 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. 2 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. 3  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. 4  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] 5 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. 6 Ref. Ares(2024)2183327 - 22/03/2024 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Digital, EU4Health and Health systems modernisation Director Brussels, SANTE.C/MM/ (2024) Permanent Representations of EU Member States and Missions to the EU of Norway, Iceland, Ukraine, Moldova and Montenegro Dear Madam, Dear Sir, The Annual EU4Health Work Programme 2024(1) adopted by the Commission on 5 December 2023 includes two categories of direct grants to Member States authorities, which are to be awarded without a call for proposals to Member States authorities, according to Article 13(5) of Regulation (EU) 2021/522(2). These are Joint Actions and Direct Grants (other than joint actions). Both of the above follow a specific procedure which requires Member States to nominate relevant competent authorities to participate in the implementation of those actions. I hereby invite you to nominate for participation on behalf of your country one or more competent authority(ies) and, if necessary, the relevant affiliated entities for: ➢ Eleven joint actions (listed in Annex I). ➢ One direct grant other than joint actions (Annex II). As mentioned also in the annexes, the nomination deadlines are differentiated as follows: • For Joint Actions (JA): o 25 April 2024 for the 1st wave JA o 21 May 2024 for the 2nd wave JA o 23 July 2024 for the 3rd wave JA • For direct grant (other than joint actions): o 23 July 2024 (1) EU4Health WP 2024 (2) EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111  Further guidance for nomination and the list of actions are included in the respective annexes. Once the nominations are received, HaDEA will provide further guidance and information to the nominated authorities and invite them to the dedicated “Hands-on workshops”. The workshops will take place closer to the opening date of the proposals’ submission under each wave. Questions related to the nomination of the competent authority(ies) can be sent to: [email protected]. In order to ensure your country's participation, I would be grateful if you could forward this letter and the enclosed annexes to the relevant national authority(ies). Yours faithfully, (e-signed) Marco MARSELLA Enclosure: Annex 1 - List of Joint Actions and indicative timeline Annex II - List of Direct Grants to Member States’ authorities (other than Joint Actions) and indicative timeline Annex III - Eligibility criteria and nomination of competent authorities c.c.: EU4Health Steering Group Members EU4Health Programme Committee Members D. Moisei, A. Di Giulio, A. Peres, (DG SANTE), L. Muschel, W. Phillip, A. Burgos Gutierrez, (HERA), F. Telea, N. Elhaggagi, G. Margetidis, C. Tripepi (HaDEA). (3) Vision, mission and values (europa.eu) Commission Electronically européenne/Europese signed on 21/03/2024 Commissie, 1049 Bruxelles/Brussel, 18:13 (UTC+01) BELGIQUE/BELGIË in accordance - Tel. with Article 11+32 of22991111 Commission Decision (EU) 2021/2121