Tercer Programa de Salud UE

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Tercer Programa de Salud UE 2014-2020 Ana Mancho Rojo, Project officer European Commission Health, Agriculture and Food Valencia, 16 de Julio 2015

Today Chafea: Who we are Overview of the 3 rd Health Programme Implementation of the health programme: Implementation of the Annual Work Plan for 2014. Statistics Annual Work Plan 2015- Calls 2015 Project proposals Joint Actions Operating grants Prizes Call for tenders 2

Health, Agriculture and Food CHAFEA 3

EAHC Chafea: Who we are The Chafea is one of six executive agencies set up by the European Commission to execute complex Community programmes and enable the Commission to focus on policy making The Chafea was formerly EAHC ( for Health and Consumers and before the Public Health Executive (PHEA). In 2008, the Agency's name was changed to EAHC, the mandate was prolonged and expanded to include actions in consumer protection and training for safer food 4

CHAFEA: Facts and figures Based in Luxembourg Staff: ~50 (for the 3 programmes) Manages nearly 500 public health actions: projects, operating grants, conferences, joint actions, international agreements and service contracts under the Health Programme 2008-2013 Administers relationships with diverse types of beneficiaries: non-governmental organisations, public sector bodies, public administrations, universities, higher education establishments, commercial firms from all EU member states, with different capacities, experience and working cultures. 5

DG SANTE Policy Priorities CHAFEA Publication of Calls Information workshops, Guidelines, etc. Yearly Workplan Evaluation External Evaluation (Projects, JA, etc.) EC internal evaluation (Tenders) Negotiation/ Contracting External Evaluation Monitoring/ Payments Audits Policy Development Dissemination Publications, webpages, etc. MS Contacts Archiving Summary reports, meetings 6

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Scope of the programme 9

Objetivo General Promoviendo la salud fomentando la innovación en la sanidad Complementar y apoyar las políticas de los Estados miembros, y proporcionarles un valor añadido, para mejorar la salud de los ciudadanos de la Unión y reducir la desigualdades sanitarias, aumentando la sostenibilidad de los sistemas sanitarios protegiendo a los ciudadanos de la Unión de las amenazas transfronterizas graves para Health la And Food salud 10

1) Promoting health, preventing diseases and fostering supportive environments for healthy lifestyles Promover la salud, prevenir las enfermedades y fomentar entornos que propicien estilos de vida saludables, teniendo en cuenta el principio de «salud en todas las políticas». Cost-effective promotion and prevention measures for addressing tobacco, alcohol, unhealthy dietary habits, physical inactivity Chronic diseases including cancer; good practices for prevention, early detection and management, including self-management HIV/AIDS, TB and hepatitis; up-take of good practices for cost- effective prevention, diagnosis, treatment and care Legislation on tobacco products advertisement and marketing Health information and knowledge system 11

2) Protecting citizens from serious cross-border health threats Proteger a los ciudadanos de la Unión de las amenazas transfronterizas graves para la salud. Legislation in the fields of communicable diseases and other health threats (Health Security Initiative) Improve risk assessment by providing additional capacities for scientific expertise and map existing assessments Support capacity building, cooperation with neighbouring countries, preparedness planning, non-binding approaches on vaccination, joint procurement 12

3) Contributing to innovative, efficient and sustainable health systems Contribuir a unos sistemas sanitarios innovadores, eficientes y sostenibles Health Technology Assessment Up-take of health innovation and e-health solutions Health workforce forecasting and planning (number, scope of practice, skills), mobility/migration of health professionals Mechanism for pooled expertise and good practices assisting Member States in their health systems reforms Health in an ageing society, including European Innovation Partnership on Active and Healthy Ageing Legislation in the field of medical devices, medicinal products and cross-border healthcare Health information and knowledge system including Scientific Committees 13

4) Facilitating access to better and safer healthcare for EU citizens Facilitar el acceso de los ciudadanos de la Unión a una asistencia sanitaria mejor y más segura. European Reference Networks (on the basis of criteria to be set under Directive 2011/24/EU) Rare diseases (networks, databases and registries) Patient safety and quality of healthcare including the prevention and control of healthcare-associated infections Antimicrobial resistance Legislation in the field of tissues and cells, blood, organs, medical devises, medicinal products, and patients rights in cross-border healthcare Health information and knowledge system 14

Annual Work Programme 2014 - Adopted by the Commission on 26 May 2014 - Annual budget of 54, 4 million - Two parts: - Core text of Decision (Articles) - Annexes: Annex I defining actions for funding Breakdown by financing mechanism (Grants, Procurement, Other Actions) Annexes II to VII focusing on criteria (eligibility, exclusion, selection and award criteria for these actions; exceptional utility criteria; criteria for assessing the independence from industry, commercial and business or other conflicting interests) 15

Instruments under the 3 rd Health Programme Call for proposals Project Grants Grants for actions co-financed with Member States authorities (Joint Actions) Operating Grant Direct Grants to International Organizations Call for tenders Service Contracts Framework Contracts Specific Contracts under a Framework Contract Expert contracts for Evaluations and other services 16

Procurement vs. Grant To acquire a product or a service. Purpose To encourage actions indicated in the Work Plan, which fall primarily within the scope of the beneficiary s activities Call for tender Procedure Call for proposals Service Contract Legal outcome Grant Agreement The EU pays 100 % of the contract price Since the service or product has been purchased and paid for by the EU, in general it belongs to the EU in its entirety EU financial contribution Ownership EU-contribution to the overall costs (Cofunding) The ownership as a rule is vested in the beneficiary of the grant. The operator s remuneration should include an element of profit. Profit The grant must not have the purpose or the effect of producing a profit for the beneficiary. 17

Annual Work Programmes IMPLEMENTING THE HEALTH PROGRAMME 2014-2020 18

Some statistics CALL FOR PROJECTS 2014 19

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21

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ANNUAL WORK PLAN 2015 25

Resources for grants: 35 415 000 for prizes: 60 000 for procurement: 16 423 805 for other actions: 3 731 000 The total available amount: 55 629 805 26

CALLS 2015 27

The Call for Projects as a specific financing instrument CALL FOR PROPOSALS PROJECTS 28

Call for Projects What does the 3rd Health Programme say regarding co-funding of project? Grant may be awarded to fund: actions having a clear Union added value explicitly provided for duly justified in the annual work programmes co- financed by other legally established organisations: public sector bodies: research and health institutions, universities and higher education establishments non-governmental bodies private bodies 29

Call for Projects Call 2015: Projects All projects should: provide high added value at EU level; involve at least three partners (separate legal entities) from different countries NEW!!; be innovative, and normally last no longer than three years. Co-funding: 60% - up to 80% - exceptional utility Electronic submission 30

Call for Projects Types of participants Project coordinator Other beneficiaries Affilited entities Several entities form one for the purpose of the action Legal and/or financial link to another beneficiary Must comply with eligibility criteria Subcontractors Do not sign grant agreement Get 100% of the cost reimbursed Collaborating stakeholders Do not sign the grant agreement Cost not eligible applicants 31

Call for Projects Eligibility criteria Applicants must be legally established. Only applicants from the 28 EU Member States plus Norway and Iceland can apply. A project proposal must be submitted by at least 3 different legal entities from 3 different eligible countries. The only eligible activities are those listed in section 2.1 "Grants for projects" in the work programme 2015. The co-funding is meant for a future project. Running projects cannot be supported. 32

Call for Projects Exclusion criteria Exclusion from participation: being bankrupt, convicted of an offence concerning professional conduct, guilty of grave professional misconduct not in compliance with their obligations relating to the payment of taxes Exclusion from granting procedure: conflict of interest guilty of misrepresenting the information required by the Agency 33

Call for Projects Project co-funding 60% of the total eligible cost 80% - if exceptional utility There is not obligation for each applicant to contribute equally to the project's budget The minimum required percentage of own contribution applies at the project level 34

Call for Projects Exceptional utility Co-funding may be up to 80% 3 criteria: At least 60 % of the total budget of the action is used to fund staff At least 30% of the budget of the proposed action is allocated to Member States whose gross national income (GNI) per inhabitant is less than 90 % of the Union average. The proposal demonstrates excellence in furthering public health in Europe and has a very high EU added value. It is your responsibility to ensure that the proposals complies with criteria 1 & 2 35

Call for Projects Key dates calls for projects - 2015 Calls open: 5 June 2015 Calls close: 15 Sept 2015 Electronic submission system Evaluation from end-september to beginning November Adaptation Award Decision Signature- January 2016 36

Call for Projects Topics open for submissions for project proposals 37

Priorities PJ-01-2015: Gathering knowledge and exchanging best practices on measures reducing availability of alcoholic beverages La recopilación de conocimientos y el intercambio de las mejores prácticas sobre medidas de reducción de la disponibilidad de bebidas alcohólicas PJ-02-2015 Early diagnosis and treatment of viral hepatitis Diagnóstico precoz y tratamiento te la hepatitis viral PJ-03-2015 Early diagnosis of tuberculosis Diagnóstico precoz de la tuberculosis PJ-04-2015 Support for the implementation and scaling up of good practices in the areas of integrated care, frailty prevention, adherence to medical plans and age-friendly communities Apoyo a la ejecución y ampliación de las buenas prácticas en las áreas de atención integral, la prevención de la fragilidad, la adhesión a los planes médicos y "comunidades amigas" de los mayores PJ-05-2015 Common assessment methodology on quality, safety and efficacy of transplantation therapies Metodología de evaluación común sobre la calidad, seguridad y eficacia de las terapias de trasplante http://ec.europa.eu/research/participants/portal/desktop/en/opportunities/3hp/calls/hp-pj-2015.html 38

Call for PROJECTS TOPIC 1 (PJ-01-2015) 2.1.1.1. Gathering knowledge and exchanging best practices on measures reducing availability of alcoholic beverages The activities should aim at testing methods/tools and at identifying good practices on reducing heavy episodic drinking amongst young people in different settings and different Member States through measures reducing availability of alcoholic drinks. The activities would also analyse the impact of such measures reducing availability (in terms of reducing harmful alcohol use, in particular heavy episodic drinking amongst young people). Priority should be given to initiatives aiming at identifying good practices targeting young people among the lowest socioeconomic groups and encourage EU networking and good practise exchange. Available Budget 1.700.000 EUR 39

Call for PROJECTS TOPIC 2 (PJ-02-2015) 2.1.1.2. Early diagnosis and testing of viral hepatitis The activities will support the development of national hepatitis strategies, screening and treatment guidelines, taking into account available treatment options. It will help to bridge primary, secondary care, and outreach, in the community including prison health services, to facilitate access to and uptake of testing, vaccination and treatment services particularly among key risk groups including drug users, prisoners, homeless, men who have sex with men, sex workers and people living with HIV/AIDS. It will also assess the potentially considerable economic impact of available treatment, testing strategies and vaccination options on health systems, which are under the responsibility of the EU Member States, with a view to inform decisions on balancing access to medicines and vaccines with the financial sustainability of health systems. Available Budget 1.600.000 EUR 40

Call for PROJECTS TOPIC 3 (PJ-03-2015) 2.1.1.3. Early diagnosis of tuberculosis The activities aim at improving early diagnosis, strengthening integration of care, and outreach strategies in the community and in prison settings, and will draw on evidence and best practice from low- and high-incidence countries. They will furthermore strengthen national TB responses by supporting the development and implementation of national strategic plans and guidelines with a particular focus on improving the control of multi-drugresistant (MDR) TB and the implementation of evidence based, state of the art diagnostics and treatment options. The action will facilitate collaboration amongst EU Member States particularly in relation to vulnerable groups including migrants, homeless, prisoners and people who inject drugs with a view to support access to and continuity of care Available Budget 1.900.000 EUR 41

Call for PROJECTS TOPIC 4 (PJ-04-2015) 2.1.3.1. Support for the implementation and scaling up of good practices in the areas of integrated care, frailty prevention, adherence to medical plans and age-friendly communities Building upon previous work conducted in these areas, the activities to be addressed will include: (i) identification of benchmarks focusing on successful local interventions with high transferability potential and (ii) support to the twinning, coaching, and/or scaling up of identified good practices on: integrating health and social care in age-friendly community settings; community programmes implementing tools and European guidance on age-friendly communities that use a participatory approach and respond to needs of older people; integrated community-based approach programmes for the screening, assessment, prevention and management of frailty in older people, and development of interventions for adherence to treatment and medical plans, in particular involving health care professionals, patients in the community, caregivers and community pharmacies. Available Budget 2.500.000 EUR 42

Call for PROJECTS TOPIC 5 (PJ-05-2015) 2.1.3.1. Common assessment methodology on quality, safety and efficacy of transplantation therapies The activities should develop a framework for assessing and verifying the quality, safety and efficacy of therapies with human tissues and cells. They should include criteria, parameters and methodologies for evaluation. An important focus will be on implementation, i.e. how these parameters and methodologies can be used by clinical actors in their daily practice to assess the quality, safety and efficacy of the tissues/cells clinical applications. The activities should include testing and validation of the proposed framework through prospective and/or retrospective studies. They should include measures to ensure that such a framework can be made available to and shared amongst the clinical actors in the field. They should consult all interested stakeholders, including professional societies and Member States competent authorities in order to ensure the acceptability of the proposed framework at all levels. Available Budget 1.300.000 EUR 43

Any questions about the Call for Projects?? 44

Actions co-finances with Member States Authorities JOINT ACTIONS 45

Joint Actions Actions co-financed with Member States authorities Joint Actions Joint Actions have a clear EU added value Co-funding 60% / 80% Country eligibility: MS /EEA NEW: direct grant to named beneficiaries MS: nominate participants prior to invitation to prepare proposal Can nominate: - Competent authorities - Public sector bodies / NGO via a transparent procedure Letter has been sent to PermRep: deadline 09/10/2015 46

Joint Actions How much co-funding? EU contribution is 60 % of the total eligible cost; In cases of exceptional utility, it is 80 %. At least 30 % of the budget of the proposed action is allocated to MS whose gross national income (GNI) per inhabitant is less than 90 % of the Union average. This criterion intends to promote the participation from MS with a low GNI. Bodies from at least 14 participating countries participate in the action, out of which at least four are countries whose GNI per inhabitant is less than 90 % of the Union average. This criterion promotes wide geographical coverage and the participation of MS authorities from countries with a low GNI. 47

Joint Actions 17,9 mio for the following actions co-financed with MS authorities : JA-01-2015 Health Technology Assessment cooperation ( 12 mio EU co-funding) - Cooperación en la evaluación de tecnologías sanitarias JA-02-2015 Prevention of Frailty ( 3,5 millions EU co-funding) Prevención de la fragilidad JA-03-2015 Market surveillance of medical devices ( 850,000 EU co-funding) Vigilancia del mercado de productos sanitarios JA-04-2015 Rare cancer ( 1.5 million EU co-funding) Cánceres raros 48

Call for Projects The Role of the MS MS to nominate participants prior to Chafea invitation to prepare the proposal Participants Competent authorities (national or regional level) or other bodies (public sector body/ngo: nominated via a transparent procedure, according to relevant national legislation) to participate in one or more of the listed JA 49

Joint Actions Competent Authorities If more than 1 CA exists in a given public health field at MS/regional level, several competent authorities can be nominated: + Nominations must be submitted separately for each CA "explanation why two or more competent authorities have been nominated" 50

Joint Actions Body other than a competent authority to participate: The designation must be done through a transparent procedure and according to its relevant national legislation. Article 190(1)(d) of the Rules of Application of the Financial Regulation, the Member State/EEA is fully responsible to put in place the designation procedure and ensure that the requirements of transparency and legality are respected. Third Health Programme (Articles 7 and 8) public sector bodies, in particular research and health institutions, universities and higher education establishments as well as non-governmental bodies can be mandated to participate in the joint action on behalf of the Member State/EEA country. 51

Joint Actions Letter to the Permanent Representatives 52

Joint Actions The submission of the nominations shall be done through a web based tool: https://ec.europa.eu/eusurvey/runner/nominationsjo intactions2015healthprogramme Deadline for NOMINATIONIONS ***** 09 October 2015 ***** 53

Joint Actions Key dates Joint Actions - 2015 05/06/2015: Letter from the Commission to the Permanent Representations 09/10/2015 Deadline for nominations 12/11/2015 (tbc) Infoday on Joint Actions 17/12/2015 (tbc) Electronic submission of the proposal End January 2016 (tbc)- Evaluation of the proposals 54

Any questions about the new procedure for the Joint Actions? 55

The Call for Operating Grants as a specific financing instrument OPERATING GRANTS 56

Operating Grants No call for proposals will be organised as a result of the conclusion of framework partnership agreement (FPA) for a duration of 3 years covering the operating years 2015,2016 and 2017. FPA recipients are eligible for a specific grant agreement. In 2015 hey will be invited to submit an application for a specific grant agreement for 2016. Having received an FPA does not guarantee annual cofunding. Resources: EUR 4,650,000 57

Operating Grants Advantages of the new procedure Sustainability: the partnership will be based on alignment at the strategic level o One FPA call covering three years of operations Predictability: Invitation based (i.e. no Call) submission of SGA proposals for each year of the FPA o SGA co-funding will be based on alignment between strategic plan and operational objectives Simplification: less administrative burden on beneficiaries o No need to re-submit supporting documents each year 58

Any questions? 59

PRIZES 60

Prizes Prizes Health award In the context of the Health Policy Forum rewards & highlights good practices / initiatives International, European, national and/or sub-national nongovernmental bodies significant contribution towards promoting a healthier EU fairer access to healthcare for EU citizens, preventing diseases protecting EU citizens health 60 000 61

Prizes Implementation Implementation by the Commission Call for applications for the EU Health Award 2015 (11-06-2015) EU Health Award 2015 for NGOs - Making a difference in fighting Ebola 62

Prizes The deadline for submitting applications is 31 July 2015, 23.59 CET/Brussels Time. Prizes for the winners are as follows: 1st prize: 20 000 2nd prize: 15 000 3rd prize: 10 000 http://ec.europa.eu/dgs/health_foodsafety/dyna/enews/enews.cfm?&al_id=1598 Eligibility, exclusion, selection and award criteria 63

Procurement CALL FOR TENDERS 64

Call for tenders Priorities Procurement 2015 4.1.3. Surveys and target prevention projects for training of health professionals in the area of HIV/AIDS (Open Call) 4.2.3. Public health preparedness and response training and exercise (Open Call, Framework) 4.3.1. Health innovation and e-health: Use of e-health and Big Data in Healthcare Policy and Research (Open Call) 4.3.4. ESIF support in the area of health: building knowledge and capacities for monitoring and implementation, supporting innovation and effectiveness (Open Call) 4.3.14. Impact of health systems on health status of the population (Open Call) 4.3.15. Health System Performance Assessment - Integrated care assessment 4.4.1. ERN - Selection of the independent assessment/evaluation body(ies) in charge of the assessment of the applications of Network and membership proposals - Technical assistance (Framework) 4.4.1. Methodology and recommendations for the development of clinical decisionmaking tools (CDMT) such as clinical guidelines, consensus documents and patient pathways - Study (Open Call) 4.4.2. Preparatory work to set up a framework for a sustainable EU collaboration on patient safety and quality of care (Open Call) 4.1.5. Tobacco Tracking and Tracing - Tobacco legislation - tracking and tracing (Open Call)

Any questions about the Calls for tenders?? 66

Thank you for your attention! Ana Mancho Rojo Project Officer European Commission Health, Agriculture and Food Health Unit CHAFEA-HP-CALLS@ec.europa.eu http://ec.europa.eu/eahc/ 67 67