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Ref. Ares(2022)1885690 - 15/03/2022 ANNEX III INFORMATION ON JOINT ACTIONS INCLUDING ELIGIBILITY CRITERIA 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, 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  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. 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 Applicants’ eligibility criteria 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, by relevant international health organisations, 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 competent authority3 responsible for implementing the action on their behalf. The nomination should confirm that:  the nominated entity will be acting as a competent authority for the given action; and  the nominated entity and its affiliated entities 4 are eligible 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 A nominated competent authority will 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 competent authority, which will become the grant beneficiary and be responsible for the implementation of the action on its behalf. The competent authority manages and carries out the Joint Action together with the coordinator (lead competent authority for the joint action) contributing with their own funding and ensuring that the objectives of the Joint Action are met. The nominated competent authority may involve in the grant under its responsibility other participants, such as affiliated entities, 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. For Joint Actions, affiliated entities in the public sphere 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. 3.2. Subcontractors These are entities subcontracted by the nominated competent authorities for the purpose of providing special expertise to the Joint 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, if 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. 6 Referred in Articles 136 (1) and 141 (1) of the Financial Regulation. 7 Article 187 of the Financial Regulation. 4 5. SUBMISSION OF NOMINATIONS VIA EU SURVEY WEBSITE The submission of the competent authority nominations per Joint Action of the second wave under the EU4Health Programme 2022 shall be done through the EU Survey website following this link: https://ec.europa.eu/eusurvey/runner/EU4HEALTH_JA2022 The password is: JA2022! 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] 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’s Data Protection 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. 5 Ref. Ares(2022)1885690 - 15/03/2022 ANNEX II GUIDANCE FOR NOMINATION AND LIST OF DIRECT GRANTS TO MEMBER STATES’ AUTHORITIES (OTHER THAN JOINT ACTIONS) AND INDICATIVE TIMELINES Guidance for nomination The submission of the competent authority nominations per direct grants other than joint actions shall be done through the EU Survey website following this link: https://ec.europa.eu/eusurvey/runner/DG_to_MS_2022 The password is: EU4H2022! The reference to “Member States’ authorities” means “authorities of Member States and of third countries’ associated to the EU4Health programme”. Unless specified otherwise all Member States and third countries’ associated to the EU4Health programme are eligible to participate in each action. List of Direct Grants and specific deadlines (per wave) 1st wave - deadline for the nomination is 22.04.2022 – EU4H-2022-DGA-MS-IBA-01: Direct grants to Member States’ authorities: enhancing whole genome sequencing (WGS) and/or reverse transcription polymerase chain reaction (RT-PCR) national infrastructures and capacities to respond to the COVID-19 pandemic and future health threats (HERA) (AWP Ref: CP-g-22-01.04) – EUR 39 000 000 EU co-funding. o Sub-topic 1: Establishment of enhanced WGS and RT-PCR infrastructures and capacities in the Member States that have not already received support for such activities in 2021 from ECDC1. Consequently, only legal entities established in the following countries are eligible to participate to the action: Bulgaria, Cyprus, Denmark, Italy, and Slovakia. 1 ECDC procedure Grant/2021/PHF/23776 “Enhancing Whole Genome Sequencing (WGS) and/or Reverse Transcription Polymerase Chain Reaction (RT-PCR) national infrastructures and capacities to respond to the Covid-19 pandemic in the European Union and European Economic Area” Agence exécutive européenne pour la santé et le numérique / Europees Uitvoerend Agentschap voor gezondheid en digitaal beleid, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 [email protected]  o Sub-topic 2: Consolidation of WGS and RT-PCR activities in countries that received support in 2021 aiming to ensure the sustainable use and integration of enhanced infrastructure into routine surveillance and outbreak investigation activities, in synergy with relevant on-going work at international level. Consequently, only the legal entities established in the following countries are eligible to participate to the action: Austria, Belgium, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden. – EU4H-2022-DGA-MS-IBA-02: Direct grants to Member States’ authorities: supporting the maintenance of the European Medical Device Nomenclature (AWP Ref: HS-g-22-19.02) – EUR 1 800 000 EU co-funding. It is essential that the Italian Health Ministry continues to provide its support and competences, ensuring adequate maintenance of the EMDN. Indicative timeline for submission of the proposal (1st wave): Opening date 03.05.2022; Submission deadline 30.06.2022 2nd wave - deadline for the nomination is 01.09.2022. Information on countries that are eligible to participate to the actions of the 2nd wave will be provided timely before the nomination deadline and as soon as related policy developments are available. – EU4H-2022-DGA-MS-IBA-03: Direct grants to Member States’ authorities: expansion of MyHealth@EU Digital Service Infrastructure (eHDSI) with new services and to more Member States (AWP Ref: DI-g-22-21.01) – EUR 30 000 000 EU co-funding – EU4H-2022-DGA-MS-IBA-04: Direct grants to Member States’ authorities: setting up services by Health Data Access Bodies – Secondary use of health data (AWP Ref: DI-g-22-22.01) – EUR 30 000 000 EU co-funding Indicative timeline for submission of the proposal (2nd wave): Opening date 15.09.2022 Submission deadline 31.01.2023 3rd wave - deadline for the nomination is 01.09.2022. – EU4H-2022-DGA-MS-IBA-05: Direct grants to Member States’ authorities: setting up a coordinated surveillance system under the One Health approach for cross-border pathogens that threaten the Union (AWP Ref: CP-g-22-04.01) – EUR 20 000 000 EU co-funding Indicative timeline for submission of the proposal (3rd wave): Opening date 15.12.2022 Submission deadline 15.03.2022 2 Ref. Ares(2022)1885690 - 15/03/2022 ANNEX I GUIDANCE FOR NOMINATION AND INDICATIVE TIMELINE ON THE JOINT ACTIONS OF THE 2022 WORK PROGRAMME Guidance for nomination The submission of the competent authority nominations per Joint Action shall be done through the EU Survey website following this link: https://ec.europa.eu/eusurvey/runner/EU4HEALTH_JA2022 The password is: JA2022! The deadline for the nomination is 1 September 2022. The reference to “Member States’ authorities” means “authorities of Member States and of third countries’ associated to the EU4Health programme”. List of Joint Actions  EU4H-2022-JA-01: Direct grants to Member States’ authorities: implementation of AMR measures in Member States (AWP1 Ref: CP-g-22-02.01) – EUR 50 000 000 EU co-funding  EU4H-2022-JA-02: Direct grants to Member States’ authorities: Cancer and other NCDs prevention – action on health determinants (AWP Ref: CR-g-22-08.01)– EUR 75 000 000 EU co-funding  EU4H-2022-JA-03: Direct grants to Member States’ authorities: prevention of NCDs – cardiovascular diseases and diabetes (AWP Ref: DP-g-22-06.03) – EUR 55 000 000 EU co-funding. One or two thematic joint actions (to be confirmed)  EU4H-2022-JA-04: Direct grant to Member States’ authorities: contribution to the Cancer Inequalities Registry to monitor national cancer control policies (AWP Ref: CR-g-22-10.03) – EUR 1 000 000 EU co-funding.  EU4H-2022-JA-05: Direct grants to Member States’ authorities: support ERNs integration to the national healthcare systems of Member States (AWP Ref: HS-g-22- 16.02) – EUR 11 200 000 EU co-funding.  EU4H-2022-JA-06: Direct grants to Member States’ authorities: increasing capacity building of the EU medicines regulatory network (AWP Ref: HS-g-22-17.02) – EUR 8 000 000 EU co-funding.  EU4H-2022-JA-07: Direct grants to Member States’ authorities: piloting a new model approach for assessing and authorising novel Blood, Tissues and Cells (BTC) preparation processes (AWP Ref: HS-g-22-18.01) – EUR 1 500 000 EU co-funding. 1 Annual work programme unique identifier Agence exécutive européenne pour la santé et le numérique / Europees Uitvoerend Agentschap voor gezondheid en digitaal beleid, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 [email protected]  EU4H-2022-JA-08: Direct grants to Member States’ authorities: reinforced market surveillance of medical devices and in vitro medical devices (AWP Ref: HS-g-22-19.01) – EUR 4 000 000 EU co-funding.  EU4H-2022-JA-09: Direct grants to Member States’ authorities: preparatory actions for a European Health Data Space; primary use of data (for healthcare) and reuse of data (AWP Ref: DI-g-22-22.06) – EUR 4 000 000 EU co-funding. Indicative timeline for proposal submission: Opening submission date 15.09.2022 Submission deadline 13.01.2023 2 Saatja: [email protected] <[email protected]> Saaja: [email protected] Teema: EU4Health 2022 Work Programme - Invitation to Member States to nominate competent authorities for Joint Actions and Direct grants other than Joint Actions Our reference: Ares(2022)1885690 Excellency, Please find attached a letter from Mr John-F Ryan, Acting Deputy Director-General for Health, on the above-mentioned subject. Kindly note that this letter is sent by e-mail only. Best regards, EU4Health Programme Secretariat Ref. Ares(2022)1885690 - 15/03/2022 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Public health The Acting Deputy Director-General Brussels, SANTE.DDG1/ Permanent Representations/ Missions to the EU of all Member States, Norway and Iceland Dear Sir, / Dear Madam, The Annual EU4Health Work Programme 20221 adopted by the Commission on 14 January 2022 includes two categories of direct action 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. The procedures for joint actions and direct grants other than joint actions are different and require 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 competent authority for each of:  the nine joint actions; pending relevant policy developments the joint action on non-communicable diseases may be split in two thematic joint actions and an additional nomination may be need; details to follow in due course (see Annex I).  the five direct grants other than joint actions (Annex II). As mentioned also in the annexes the nominations deadlines, are differentiated as follows:  for joint actions: 01.09.2022;  for direct grants (other than joint actions): o 22.04.2022 for the 1st wave; o 01.09.2022 for the 2nd and 3rd wave of direct grants. Further guidance for nomination and the list of actions are included in the respective annexes. Please note that nominations received after the above-specified deadlines will not be taken into account and earlier inputs are very much encouraged. 1 C(2022) 317 final and its Annex: https://ec.europa.eu/assets/sante/health/funding/wp2022_en.pdf 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG  To support the nomination process, the European Health and Digital Executive Agency (HaDEA)3 will organise a general info day on the 10th of May 2022 focusing on the nominations, and to provide information related to joint actions and direct grants that are not joint actions (only for the 2nd and 3rd waves). For the urgent direct grants under the 1st wave with an earlier deadline any questions should be addressed by email to HaDEA- [email protected] . Once the nominations have been received, HaDEA will contact the nominated authorities with further information and invite them to dedicated ‘hands on workshops’ as follows: - 12 of May 2022, for direct grants other than joint actions (only the 1st wave); for the 2nd and 3rd wave more details will be provided in due course to the nominated authorities. - 13-14-15th September 2022, for joint actions. 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 authorities of your choice, which will then receive more details from HaDEA. Yours faithfully, (e-signed) John-F RYAN (acting) Enclosure: Annex 1 - List of Joint Actions included in the 2022 Annual Work Programme 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 in the Joint Actions 2022 c.c.: Health Attachés of all Member States, Norway and Iceland EU4Health Steering Group Members EU4Health Programme Committee Members DG SANTE: Mr M. Hudson, Mr A. Rys, Mr J. F. Ryan, Mr A. Peres HaDEA: Ms F. Telea, Ms N. Elhaggagi, Ms M. Di Stasi, Mr G. Dargent 3 https://hadea.ec.europa.eu/about-hadea_en 2 Electronically signed on 15/03/2022 08:57 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121 Saatja: Webdesktop <[email protected]> Saadetud: 16.03.2022 18:00 Adressaat: SM Info <[email protected]>; Elen Ohov <[email protected]> Koopia: <[email protected]> Teema: Webdesktop: Kiri nr 14-4/285 / EU4Health 2022 Work Programme - Invitation to Member States to nominate competent authorities for Joint Actions and Direct grants other than Joint Actions Manused: 285.pdf; 285_lisa_1.pdf; 285_lisa_2.pdf; 285_lisa_3.pdf; 285.msg Tere! Edastan Euroopa Komisjoni kirja. Siin on nüüd mitu nimetamise tähtaega. Reg. number: 14-4/285 Reg. kuupäev: 16.03.2022 Sisu: EU4Health 2022 Work Programme - Invitation to Member States to nominate competent authorities for Joint Actions and Direct grants other than Joint Actions Heade soovidega Tiiu Noobel [email protected] sekretär, EV alaline esindus EL juures