The Third EU Health Programme

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The Third EU Health Programme With a focus on joint actions Stockholm, 22 August 2014 Dirk MEUSEL Scientific Project Officer European Commission Health and Food Exectutive Agency (Chafea)

What's new? EAHC became Chafea 3 rd Health Programme Financing Instruments have changed Use of Electronic Exchange Systems, aligned with the HORIZON 2020 Programmes Electronic Submission Electronic Evaluation Electronic Grant preparation and monitoring Electronic Signatures Model Grant Agreement, Payments, Cost structure, simplifications

Health and Food CHAFEA

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

History, Objectives and Budget 3 RD HEALTH PROGRAMME

1993-2002 8 different Action Programmes (health promotion, cancer, drug dependence, AIDS and other communicable diseases, Past and health Future monitoring, rare diseases, accidents and injuries, pollution-related diseases) 2003-2007 312 Mio. 2008-2013 321,5 Mio. 2014-2020 449,4 Million Community Action Programme for Public Health Health Information Health Threats Health Determinants 2 nd Programme of Community Action in the field of Health Health Security and Safety Health Promotion and Health Inequality Health Information 3 rd Programme of Community Action in the field of Health Promote health, prevent diseases and foster supportive environments for health lifestyles Protect citizens from serious cross-border health threats Contribute to innovative, efficient and sustainable Health Systems Facilitate access to better and safer healthcare for Union citizens

Health in the MFF 2014-2020 THE CHALLENGES increasingly challenging demographic context threating the sustainability of health systems fragile economic recovery limiting the resources available for investment in healthcare increase of health inequalities between/within Member States increase in chronic diseases prevalence pandemics and emerging crossborder health threats rapid development of health technologies Third Health Programme - Regulation (EU) 282/2014 - Commission proposal (November 2011) - The only programme dedicated to health - Published 21 March 2014 - Applies retroactively from 1 January 2014 - Workplan 2014 adopted 26 May 2014

The design of the Programme as compared to previous Programmes Objectives more focused and tangible (SMART) Limited number of actions prioritised on EU added value criteria (21 thematic priorities Annex I of Programme Regulation) Progress indicators to monitor the objectives and the impact Annual Work Plans based on long-term policy planning Better dissemination and communication of results Simplification of administrative and financial procedures

New Annex II Criteria for establishing annual work programmes Policy Relevance EU added value Public health relevance Support to implementation of legislation Pertinence of geographical coverage Balanced distribution of resources between objectives Adequate coverage of thematic priorities

1) Promoting health, preventing diseases and fostering supportive environments for healthy lifestyles 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 selfmanagement 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

2) Protecting citizens from serious cross-border health threats 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

3) Contributing to innovative, efficient and sustainable health systems 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

4) Facilitating access to better and safer healthcare for EU citizens 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

Implementation Annual Work Programmes The Commission implements the Programme by establishing annual work programmes in accordance with Regulation (EU, Euratom) No 966/2012 and the criteria set out in Annex II of the Regulation (EU) No 282/2014 Programme Committee Members The Commission is assisted by a committee for establishing the annual Work Plans and monitor the Programme implementation. National Focal Points Member states designate National Focal Points for the promotion of the Programme and the dissemination of the Programme results and the identification of impacts generated http://ec.europa.eu/chafea/health/national_focal_points.html Consumer, Health and Food (CHAFEA) The Agency is entrusted by the Commission to implement the Health Programme, working in close collaboration with DG SANCO

in Mio Euro Yearly Health Programme Budget 70 60 50 50,7 52,8 51,4 53,2 55,7 57,7 54,4 53,63 55,91 58,16 59,9 61,68 62,98 40 30 20 10 2 nd EU Health Programme 3 rd EU Health Programme 0 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Year of Budget Planning

In Mio. Euro Budget Comparison to other EU Programmes 8000 7471,8 7000 6000 5000 4000 3000 2000 3851,4 1000 0 1. Health, demographic change and well-being 2. Food security, sustainable agriculture and forestry, marine, maritime and inland water research, and the bioeconomy Horizon 2020 III Societal challenges, of which Programme Budget 2014-2020 449,39 3rd Health Programme

Projects, Operating Grant Partnerships, Joint Actions INSTRUMENTS

Interventions: Grants for projects Financial provisions Actions cofinanced with Member State Authorities ("Joint Actions") Operating grants Direct grants to International Organisations Public procurement (tenders, framework contracts) Beneficiaries (recipients of funding) Legally established organisations in EU MS, plus Norway & Iceland Public authorities, public sector bodies (research and health institutions, universities and higher education establishments) Non-governmental bodies International organisations

Instruments Open Calls for Proposals Projects Framework Partnerships for Operating Grants Direct Grants Actions cofinanced with Member State Authorities ("Joint Actions") Direct grants to International Organisations Presidency Conferences Procurement (Service Contracts) Open call for Tenders Requests for services under existing Framework contracts Experts for evaluations

PROJECT GRANTS

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

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

Actions co-financed with Member State Authorities JOINT ACTIONS

New procedure for Actions co-financed with Member States authorities (Joint Actions) Direct Grant Agreement (without a call for proposals) It simplifies the whole process (direct negotiation with MS) It is clear and transparent vis-à-vis MS, and the respective role of DG SANCO and Chafea It provides more time for the finalisation of the GA (not bound with the strict deadlines of the call for proposals)

3rd HP: New procedure for JA Direct grant procedure = > all participants have to be nominated first (no open call!) If a European umbrella organisation/ngo wants to participate in a JA, it must be designated by a MS competent authority through a transparent procedure. For the "follow-up" JA (second phase of an existing JA): because an organisation is part of the running/finishing JA, this organisation is not automatically designated to participate in the new JA on the same topic! As in PHP2, international organisations (e.g. WHO, OECD, etc.) are not eligible to participate. Chafea will carry out spot checks concerning the transparency and legality of the designation process.

How much co-funding? EU contribution is 60 % of the total eligible cost; In cases of exceptional utility, it is 80 %. Who can participate? Country eligibility EU28 and EEA (Norway and Iceland). Focus: MS authorities Public sector bodies and non-governmental bodies from the above countries can participate in JA, if they are mandated by competent authorities.

Exceptional utility criteria 1. 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. 2. 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.

Idea of Actions cofinanced with Member State Authorities Member State Involvement Project Project Joint Action Sustainable structure

http://ec.europa.eu/chafea/documents/health/leaflet/eahc-joint-action.pdf

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

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"

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.

Letter to the Permanent Representatives

Templates To be completed and sent to: CHAFEA-HP-JA@ec.europa.eu and hardcopies (originals) to: Consumer, Health and Food (Chafea), Health Unit, For the attention of Ms Maria Alonso, DRB АЗ/022, L-2920 Luxembourg via the Permanent Representatives

Next steps 1. Nomination of participants Deadline: 16 September 2. Chafea sends the Invitation letter to prepare the grant agreement for the designated competent authorities 3. Information session on Joint Actions, by late September/early October 4. ADVANCED DRAFT PROPOSALS 2 deadline options; Mid November Or Mid-January 5.Remote assessment of JA 6. Discussion among JA coordinators and evaluators AWARD DECISION 7. ADAPTATION of the JA proposal in SYGMA

Call for tenders SERVICE CONTRACTS

Procurement vs. Grant

Example of Service Contracts

Procurement principles Principle of transparency Principle of proportionality Principle of equal tratment and non-discrimination 43

1. Publication TED Tenders Electronic Daily

Chafea website

Deadline Tender Specifications PDF Form

2. Preparation Who can participate? If during the preparation you have any doubt: Chafea-HP-TENDER@ec.europa.eu Natural and legal persons from: The Member States of the European Union Countries of the European Economic Area (Norway, Iceland and Liechtenstein). Types of tenderer: - Single tenderer - Single Tenderer with Subcontractor - Consortium - Consortium with Subcontractor

Consortia (Groups of economic operators ) The offer shall clearly specify the role and tasks of each member of the consortium: - The consortium leader: with full authority to bind the consortium and each of its members - Each partner shall fulfil the requirements and accept the terms and conditions set out in the ToR, the contract as well as in all the relevant Annexes. In case of awarded the tender: all members of the consortium will be jointly and severally liable towards the contracting authority for the performance of the contract.

3. Submission The Tender must include 3 envelopes: Envelope A: Administrative proposal Envelope B: Technical proposal Envelope C: Financial proposal (see PDF form which has to be completed). The offer has to be sent to Chafea by registered mail or by courier post mail, in a sealed packet containing the 3 envelops, before the date of deadline.

Information on new tenders If you would like to be notified when calls for tender are launched, please request to be added to our mailing list by writing to: CHAFEA-HP-TENDER@ec.europa.eu Or visit: http://ec.europa.eu/chafea/health/tenders.html

Projects, Operating Grants, Joint Actions ELECTRONIC EXCHANGE SYSTEMS

Applying for funding Find a Call Find partners Register an organisation Submit a proposal Evaluation & Grant signature Evaluation of proposals Grant preparation Grant signature Grant Management Reports Dissemination of results Amendments Audits & certifications Expert registration Experts opinion Contracting & payment Expert roles & tasks

New system = new terminology (1) The Participant Portal (PP) is the website hosting the information about funding for the third Health Programme (2014-2020) and Horizon 2020 programmes http://ec.europa.eu/research/participants/portal/desktop/en/h ome.html The ECAS account is the European Commission's Authentication Service. It is the system for logging on to a whole range of websites and online services run by the Commission. The Beneficiary Register is the European Commission's online register of the beneficiaries participating in EU Programmes, such as Horizon 2020 programmes, the Health and Consumers Programmes and others.

New system = new terminology (2) The Participant Identification Code (PIC number) is a 9-digit participant identification code, received upon completing the registration of the entity online The LEAR (Legal Entity Appointed Representative) is the appointed representative within the beneficiary organisation. He/she is authorized to sign the grant agreement and action's documents on behalf of the organisation

Electronic Grant preparation Grant preparation online (ping-pong principle between agency and beneficiaries) Electronic signature by LEAR (Legel entity authorised representative) no paper copies of grant agreement Partners join the agreement after signature Monitoring and reporting online: Deliverables, Payment requests, Reports, etc.

New in Grant Management New model grant agreements, which are aligned to H2020 procedures Interim Payments Simplified cost structure (Staff, Other Costs, Subcontracting), budget shifts without amendment All partners sign the grant agreement Consortium agreements

Brochures, Webpages, Databases CHAFEA DISSEMINATION ACTIVITIES

Publications

Infodays http://ec.europa.eu/chafea/health/infoday-10062014-presentations_en.html

http://ec.europa.eu/chafea/ami/

YOUR QUESTIONS?

Thank you for your attention! Dirk Meusel DrPH, CAPM Scientific Project Officer European Commission Health and Food (Chafea) Health Unit +352 4301 33090 dirk.meusel@ec.europa.eu http://ec.europa.eu/chafea/