Annual Work Programme 2018

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1 Annual Work Programme 2018 Infoday 30 January 2018 Irène ATHANASSOUDIS DG SANTE C1

2 The Health Programme Regulation EU N 282/2014 of 11 March 2014 Promoting health Encouraging innovation in health Complement, support and add value to the policies of MS to improve the health of EU citizens and reduce health inequalities Increasing the sustainability of health systems Protecting citizens from serious crossborder health threats

3 The objectives 1) Promote health, prevent disease and foster supportive environments for healthy lifestyles Address in particular the key risk factors with a focus on the Union added value. 2) Protect citizens from serious cross-border health threats Coherent approaches integrated into MS preparedness plans 3) Contribute to innovative, efficient and sustainable health systems 4) Facilitate access to better and safer healthcare for Union citizens Innovative tools and mechanisms in health and health prevention Increase access to medical expertise and information for specific conditions

5 Major actions in the Draft WP 2018

6 Operational Budget Type Budget Projects: EUR Joint Actions: EUR Operating Grants: EUR Direct Grants: EUR Prizes EUR Procurement EUR Other actions EUR total EUR

7 Types of Action in WP 2018

8 Projects Implementation of best practices promotion of good health, prevention of non-communicable diseases and scaling up integrated care Two separate calls (A and B) Supporting Member States voluntary cooperation in the area of pricing through the Euripid Collaboration Orpha codes Project

9 2018 CALL FOR PROPOSALS FOR PROJECTS TITLE INDICATIVE AMOUNT Ref. in Work Programme 2018 Grants foreseen Implementation of best practices - scaling up integrated care EUR Section one or more Supporting Member States voluntary cooperation in the area of pricing through the Euripid Collaboration EUR Section one Orpha codes Project EUR Section one

10 Projects Multiannual specific grant agreements for European Reference Networks for a total of for the coordination, management and non-clinical activities of the approved ERNs. Invitation to Framework Partnership Agreement holders to apply for a SGA of three years The financial support can cover : networking and coordination activities; administrative and logistic support; development of knowledge generation tools (clinical guidelines, patient pathways); training and elearning; meetings of the network members and participation in conferences or events related to the network s area of expertise; any non-clinical actions that help ERNs to achieve their goals.

11 Multiannual specific grant agreements to ERNs The aim is to ensure that ERNs: offer the possibility to work in multidisciplinary teams across different EU countries; increase the level of expertise; build capacity to produce good practice guidelines, to implement outcome measures and quality control; provide support to research coordination and teaching and training activities.

12 Joint Actions Joint Action to strengthen preparedness in the EU against serious cross-border threats to health and support the implementation of International Health Regulations (IHR) This is without a call for proposals Direct procedure after close cooperation with MS competent authorities and public bodies Specific live webminar on 2 February 2018

13 Operating grants-specific Grant Agreements For the functioning of non-governmental bodies assisting the Commission by providing the information and advice necessary to the develop health policies and implement the Programme objectives and priorities. They should work on increased health literacy and promotion of healthy life styles, organise science policy conferences and help optimise healthcare activities and practices by providing feedback from patients and facilitating communication with them, thus empowering them. The Commission also encourages these non-governmental bodies to work together with the European Solidarity Corps, where appropriate.

14 Direct grant agreements to the WHO/FCTC (Framework Convention on Tobacco Control) to submit a proposal presenting a coherent programme of actions to establish the global information-sharing focal point, in particular specifying the needs for system design and software development to the OECD for regarding (a) digital strategy, (b) antimicrobial resistance and (c) selection and implementation of best practices to promote health and prevent and manage non-communicable diseases with Council of Europe's EDQM (European Directorate for the Quality of Medicines and Healthcare) for Substances of Human Origin

15 Other direct grants (de facto monopoly in line with Article 190 (1) (c) of Delegated Regulation (EU) No 1268/2012) to Orphanet for providing the rare diseases community at large with interoperability tools, an inventory of rare disease, an encyclopedia in as many languages as possible, and a directory of expert services in the participating countries. The overall outcome is to serve as the reference source of information on rare diseases for European citizens to the European Reference Network on urogenital diseases and conditions (ERN eurogen) (for three years??)

16 Presidency conference grants de jure monopoly The EU Presidencies may receive up to EUR each to organise high-level conferences during their term on the Food value chain (Food systems adding value for better health in Europe) under the Austrian Presidency; on Procurement of Medicine, medical devices, Equipment and Increasing access to therapy under the Romanian Presidency.

17 PRIZES 3.1. The EU Health Award for NGOs ( ) focuses on practices and interventions which support the implementation of the Sustainable Development Goals in priority health topics chosen by the Steering Group on Health Promotion and Prevention and Management of Non-Communicable Diseases or the Health Security Committee. The award creates an incentive for European health NGOs to share their evaluated good practices/interventions and get involved in EU health policy.

18 PROCUREMENT 4.1. Support to Member States in reducing alcohol related harm 4.2. Evaluation of the public health impact of the provisions of Article 32 of Directive 2008/118/EC 4.3. Framework contract: support services to manage expert groups 4.4. Provision of technical and scientific input to support the application, enforcement and monitoring of the Tobacco Products Directive 2014/40/EU 4.5 Actions under Multiple Framework Contract for the Scripting, planning, conduction and evaluation of exercises, training and assessment implementing the Decision No 1082/2013/EU on serious cross-border threats to health

19 PROCUREMENT 4.6. Health innovation and ehealth support to the implementation of the Digital Single Market 4.7. Scientific and technical assistance for the Expert Panel on effective ways of investing in health 4.8. Scientific Committees and provision of targeted risk assessment in case of a chemical and environmental incident of cross border relevance 4.9. Clinical trial EU portal and database Translations, info campaigns, publications etc. related to medical devices

20 PROCUREMENT Development of the future EUDAMED (the European medical devices database for the new Regulations on medical devices and in vitro diagnostic medical devices) Maintenance and required developments of the existing Eudamed Assessment of healthcare providers wishing to join established European Reference Networks (ERN) by Independent Assessment Bodies ERN implementation, including coordination, capacity building, communication, exchange of information and best practices, and other networking support actions Communication on the Health Programme and dissemination Dissemination of the results of the Health Programme Information Communication Technologies

21 Procurement - how to access information on the Chafea Website Through the TED (Tenders Electronic Daily)

22 Other actions 5.1. Direct agreement with the Joint Research Centre 5.2. Direct agreement with the Joint Research Centre: support work on e- cigarettes, ingredients and security features 5.3. Sub-delegation to Eurostat implemented through direct award of grants for morbidity statistics 5.4. Cross sub-delegation to Eurostat implemented through direct award of grants for testing new modules/variables for future European Health Interview Survey (EHIS) waves 5.5. Expert Panel on effective ways of investing in health special indemnities paid to experts

23 Other actions 5.6. Organisation and management of the meetings of the Medical Device Coordination Group (MDCG) and its subgroups 5.7. Technical, scientific and related logistic support on medical devices (JRC) 5.8. Medical devices: reimbursement of experts expenses for joint assessments carried out by several Member State authorities and the Commission services assessing the application for designation of notified bodies or extension and renewal of designations 5.9. Joint Audit Programme (JAP) on Good Manufacturing Practice (GMP) inspections for Mutual Recognition Agreement on GMP inspection between the EU and the US and other strategic partners

24 Other actions International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and VICH Outreach Forum (VOF) Active pharmaceutical ingredients: system inspections in non-eu countries International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and International Pharmaceutical Regulators Forum (IRPF) Scientific Committees and provision of targeted risk assessment in case of a chemical and environmental incident of cross border relevance Sub-delegation to Eurostat implemented through direct award of grants for non-monetary health care statistics Annual Commission membership fee to the European Observatory on Health Systems and Policies Expert evaluators

25 Resources per Objective AWP 2018

26 Allocation of budget by objective, Objective Promote health, prevent disease and foster supportive environments for healthy lifestyles 31% 23% 43% 33% 2 Protect citizens from serious cross-border health threats 10% 3% 8% 7% 3 Contribute to innovative, efficient and sustainable health systems 33% 45% 16% 31% 4 Facilitate access to better and safer healthcare for Union citizens 20% 11% 26% 19% Horizontal 7% 18% 6% 10%

27 Thank you for your attention!

WORK PLAN 2017 LAURENCE BALLIEUX NATIONAL FOCAL POINT. 1 EU 3rd HEALTH PROGRAMME

1 EU 3rd HEALTH PROGRAMME 2014-2020 WORK PLAN 2017 LAURENCE BALLIEUX NATIONAL FOCAL POINT 2 3RD HEALTH PROGRAMME Published on 21 March 2014 4 overarching objectives: Promote health, prevent diseases and