Annual Work Programme 2018

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

EU Health Programmes

ANNEX I TO VIII ANNEX I. Health Programme Work Programme for 2017

Background paper. Cross-border healthcare in the EU

The Third EU Health Programme

3rd Health Programme

REFLECTION PROCESS on CHRONIC DISEASES INTERIM REPORT

ERN Assessment Manual for Applicants

EUCERD RECOMMENDATIONS QUALITY CRITERIA FOR CENTRES OF EXPERTISE FOR RARE DISEASES IN MEMBER STATES

DRAFT OPINION. EN United in diversity EN. European Parliament 2018/0018(COD) of the Committee on Industry, Research and Energy

The Ministry of Health s support to Italian Partnerships in EU projects

Delegations will find below the above-mentioned Council conclusions, as endorsed by the Council (General Affairs) on 14 September 2015.

Implementing the 3rd Health Programme. Ingrid Keller Coordinator Health Programme Consumer, Health and Food Executive Agency

Council of the European Union Brussels, 24 February 2015 (OR. en)

EUCERD RECOMMENDATIONS on RARE DISEASE EUROPEAN REFERENCE NETWORKS (RD ERNS)

Medical devices briefing for patients: Patient safety in the new Regulation

Open Info Day Horizon 2020 'Health, demographic change and wellbeing'

Guidelines for new FOCAL POINTS

Improving patients rights

Horizon 2020 calls on. Health, Demographic change and Well-being

High Level Pharmaceutical Forum

European Solidarity Corps: Ensuring Quality, Impact and Inclusion

Societal Challenge 1: Health, demographic change & wellbeing Bucharest - Romania Dr Cristina Pascual National Documentation Centre - EKT

European Reference Networks (ERN) Guide for patient advocates

Building the Europe of Knowledge

Mix of civil law and common law. Official law database Ministry for justice, culture and local government of Malta

- Proposal for a Regulation on HTA- Ioana Siska, MD, PhD DG SANTE - Health Systems and Products Medical Products: safety, quality, innovation

Work with us as evaluator or reviewer!

COUNCIL OF THE EUROPEAN UNION. Brussels, 23 September /13 LIMITE SAN 304

Building Europe Knowledge Towards the Seventh Framework Programme

Document: Report on the work of the High Level Group in 2006

URBACT III Programme Manual

UNION EUROPÉENNE DES MÉDECINS SPÉCIALISTES

ERN Assessment Manual for Applicants 2. Technical Toolbox for Applicants

ECHA and the implementation of REACH,CLP and other tasks

BELGIAN EU PRESIDENCY CONFERENCE ON RHEUMATIC AND MUSCULOSKELETAL DISEASES (RMD)

ICH Regulators Forum. Dr Peter Arlett EU

Legal and financial issues Evaluation process

SERBIA. Preparatory measures for full participation in Erasmus+ INSTRUMENT FOR PRE-ACCESSION ASSISTANCE (IPA II)

Patient Registry Initiative- Strategy and Mandate of the Cross-Committee Task Force

CAPACITIES WORK PROGRAMME PART 3. (European Commission C (2011) 5023 of 19 July 2011) REGIONS OF KNOWLEDGE

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

Presentation of Interreg Europe

Horizon Support to Public-Public Partnershiups

The Riga Roadmap Investing in Health and Wellbeing for All

CAPACITIES WORK PROGRAMME (European Commission C(2009)5905 of 29 July 2009)

- Proposal for a Regulation on HTA- DG SANTE - Health Systems and Products Medical Products: safety, quality, innovation

EU HEALTH POLICY PLATFORM CALL TO ACTION ON ANTIMICROBIAL RESISTANCE (AMR)

e-health LEGAL CHALLENGES

COMMISSION OF THE EUROPEAN COMMUNITIES

The place of the Certification procedure in 2017 in the EU regulatory framework and beyond. Prague, 19 September 2017

Pfizer Response to the Reflection Process for a New EU Health Strategy. Enabling Good Health for All

Update of the Work plan on international activities 2012

***I DRAFT REPORT. EN United in diversity EN. European Parliament 2018/0018(COD)

Table Of Content. Strengthening voluntary cooperation between Member States to improve the health of EU citizens... 2 Summary... 3 Work Package...

Work Plan 2008: priorities Cinthia Menel Lemos (PHEA)

Continuous Professional Development of Health Professionals European Context

Cross-Border Healthcare Intervention Trials in Ireland Network (CHITIN): PRE-ANNOUNCEMENT OF FUNDING CALL

Interreg Europe. National Info Day 26 May 2015, Helsinki. Elena Ferrario Project Officer Interreg Europe Secretariat

Responsible medication processes ( pharmaceutical care ) and good pharmaceutical practices for improved patients quality of life and batter healthcare

Annex to the. Steps for the implementation

Re: Evaluation of the Hearings by the Conference of Presidents Pharmaceutical policy in the public interest

Patient Empowerment. Kostas Aligiannis, Policy Officer, European Patients Forum eupatientsforum

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

Preparation of the final technical report

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS

EUROPEAN COMMISSION HEALTH AND CONSUMER PROTECTION DG. Directorate C: Public Health and Risk Assessment Unit C2 - Health information

Council of the European Union Brussels, 8 September 2014 (OR. en) Mr Uwe CORSEPIUS, Secretary-General of the Council of the European Union

Introduction to ibmg. Marco Varkevisser Director of Education

...FREEDOM TO EXPLORE YOUR REGULATORY NEEDS

The Europe INNOVA Eco-innovation Platform. Orsola Mautone DG Enterprise and Industry Unit D.2 Support for Innovation

Therefore the provision of medicines is an area for which a Community regulatory framework should be properly supervised to ensure full and

ISCA CESS PANEL BLED, NOVEMBER 2010

Commission Guidelines for the implementation of the Clinical Trials Regulation NTA Ethics Oslo

Brussels, 12 June 2014 COUNCIL OF THE EUROPEAN UNION 10855/14. Interinstitutional File: 2012/0266 (COD) 2012/0267 (COD)

Horizon Public-Public Partnerships and the link to ERA

Work plan for GCP Inspectors Working Group for 2018

STRATEGIC OBJECTIVES & ACTION PLAN. Research, Advocacy, Health Promotion & Surveillance

Strategic thinking across the EU through the eyes of SHIPSAN

Morbidity statistics in the EU

Article 36 Cooperation

EU egovernment Action Plan

Public Diplomacy, Policy Research and Outreach Devoted to the European Union and EU-Canada Relations

GUIDELINES ON eprescriptions DATASET FOR ELECTRONIC EXCHANGE UNDER CROSS-BORDER DIRECTIVE 2011/24/EU RELEASE 1

Making Europe a safer, healthier and more productive place to work. h t t p : //o s h a. e u r o p a. e u

BBI JU Introduction & link to EU policies. Dieter BRIGITTA Project Officer

Final Draft Agenda Sixteenth meeting of the Forum for Exchange of Information on Enforcement (Forum-16) October 2013

Big data in Healthcare what role for the EU? Learnings and recommendations from the European Health Parliament

Investing in health with the European Structural and Investment Funds. Katarzyna Glowacka - Rochebonne

The Dialogue Facility THE DIALOGUE FACILITY Bridging Phase Guidelines and Criteria for Support

Implementation of REACH & CLP: common challenges of national authorities and ECHA


1. The Working Party on Public Health discussed and agreed the draft Council conclusions as set out in the Annex.

for Horizon Bucharest, Romania Flaviana Rotaru FM Management Consultancy

COUNTRY UPDATES SERIES SUMMER Greening economies in the EU Eastern Partnership countries BELARUS RECENT AND PLANNED ACTIVITIES

The Swedish national courts administration. data/assets/pdf_file/0020/96410/e73430.pdf

Horizon Health

UHC. Moving toward. Sudan NATIONAL INITIATIVES, KEY CHALLENGES, AND THE ROLE OF COLLABORATIVE ACTIVITIES. Public Disclosure Authorized

EDQM roadmap for electronic submissions

EU Datathon 2018 Strategy proposal

Transcription:

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

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

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

https://ec.europa.eu/health/funding/programme/adoption_workplan_2018_en

Major actions in the Draft WP 2018

Operational Budget Type Budget Projects: EUR 20 850 000 Joint Actions: EUR 7 900 000 Operating Grants: EUR 5 000 000 Direct Grants: EUR 6 140 000 Prizes EUR 60 000 Procurement EUR 14 730 701 Other actions EUR 7 399 000 total EUR 62 079 701

Types of Action in WP 2018

Projects 2.1.1. Implementation of best practices promotion of good health, prevention of non-communicable diseases and scaling up integrated care Two separate calls (A and B) 2.1.2. Supporting Member States voluntary cooperation in the area of pricing through the Euripid Collaboration 2.1.3. Orpha codes Project

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 3 650 000 Section 2.1.1. one or more Supporting Member States voluntary cooperation in the area of pricing through the Euripid Collaboration EUR 300 000 Section 2.1.2. one Orpha codes Project EUR 750 000 Section 2.1.3. one

Projects 2.1.4. Multiannual specific grant agreements for European Reference Networks for a total of 13 800 000 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.

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.

Joint Actions 2.2.1. 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

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.

Direct grant agreements 2.4.1. to the WHO/FCTC (Framework Convention on Tobacco Control) 400 000 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. 2.4.2. to the OECD for 1 500 000 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. 2.4.3. with Council of Europe's EDQM (European Directorate for the Quality of Medicines and Healthcare) for Substances of Human Origin

Other direct grants (de facto monopoly in line with Article 190 (1) (c) of Delegated Regulation (EU) No 1268/2012) 2.5.1. to Orphanet 2 640 000 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. 2.5.2. to the European Reference Network on urogenital diseases and conditions (ERN eurogen) 600 000 (for three years??)

Presidency conference grants de jure monopoly 2.5.3. The EU Presidencies may receive up to EUR 100 000 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.

PRIZES 3.1. The EU Health Award for NGOs ( 60 000) 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.

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

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 4.10. Translations, info campaigns, publications etc. related to medical devices

PROCUREMENT 4.11. Development of the future EUDAMED (the European medical devices database for the new Regulations on medical devices and in vitro diagnostic medical devices) 4.12. Maintenance and required developments of the existing Eudamed 4.13. Assessment of healthcare providers wishing to join established European Reference Networks (ERN) by Independent Assessment Bodies 4.14. ERN implementation, including coordination, capacity building, communication, exchange of information and best practices, and other networking support actions 4.15. Communication on the Health Programme and dissemination 4.16. Dissemination of the results of the Health Programme 4.17. Information Communication Technologies

Procurement - how to access information on the Chafea Website http://ec.europa.eu/chafea/health/tenders.html Through the TED (Tenders Electronic Daily) http://ted.europa.eu/ted/main/homepage.do

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

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

Other actions 5.10. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and VICH Outreach Forum (VOF) 5.11. Active pharmaceutical ingredients: system inspections in non-eu countries 5.12. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and International Pharmaceutical Regulators Forum (IRPF) 5.13. Scientific Committees and provision of targeted risk assessment in case of a chemical and environmental incident of cross border relevance 5.14. Sub-delegation to Eurostat implemented through direct award of grants for non-monetary health care statistics 5.15. Annual Commission membership fee to the European Observatory on Health Systems and Policies 5.16. Expert evaluators

Resources per Objective AWP 2018

Allocation of budget by objective, 2014-2016 Objective 2014 2015 2016 2014 2016 1 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%

Thank you for your attention!