EU Health Policy Recent and forthcoming developments

Legislative files

Tobacco products

• Directive 2014/40/EU adopted (in force since 19 May 2014).

Clinical Trials

• Regulation No 536/2014 adopted on 16 April 2014 In force since 16 June 2014 but will apply no earlier than 28 May 2016.

EMA fees for pharmacovigilance activities

• • Regulation (EU) No 658/2014, OJ L 189, 27.6.2014

Procedure-based fees applicable after 26 August 2014. The annual fee will be charged as of 1 July 2015,

Medical Devices

• Agreement to draft a roadmap and aim at closing technical discussions in 2014.

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Cooperation Health Determinants

Action Plan on Childhood Obesity

• Adopted by the high level group on nutrition and physical activity in february 2014 and endorsed in Council Conclusions on nutrition and physical activity (June 2014)

Action Plan on Youth Drinking and on Heavy Episodic (Binge) Drinking (2014-2016)

• Informal document, to be endorsed by the Committee on National Alcohol Policy and Action (in September 2014) • Actions are based on the current Alcohol Strategy and focusing on youth and on binge drinking 3

Cooperation Cancer

Expert group on cancer control

• Replaces the "advisory committee for cancer prevention" • • Assists with drawing up legal instruments, policy documents, guidelines and recommendations.

First meeting on 23-24th September (Milan)

Report on the European Partnership against Cancer and the Council Recommendation on cancer screening

• Foreseen adoption : September 2014 • Summary of activities of the EU cancer policy (including follow-ups on screening guidelines, national cancer plans, cancer information system and prevention) 4

Cooperation Cancer

Cancer : Comprehensive Cancer Control Joint Action (CANCON)

• Timeframe: 2014-2016 • • • • identify key elements and quality standards for comprehensive cancer control in Europe, prepare an evidence-based European Guide on Quality Improvement in Comprehensive Cancer Control; and facilitate cooperation and exchange of best practice between Member States, identify and define key elements to ensure optimal, comprehensive cancer care.

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Cooperation Major and Chronic Diseases

Reflection process and "Chronic Disease Summit"

• Summit conclusions: EU added value, gaps and needs in the repsonse to chronic diseases  towards a "Coalition on chronic diseases"

"Joint Action" on chronic diseases, 2014-2017

• 23 Member States; € 9,5 Mio • • • Collection, validation and dissemination of good practises Common guidance and methodologies for care pathways for multimorbid patients Diabetes: case study on barriers to prevention, screening and treatment; improvement of cooperation among Member States

UN process on non-communicable diseases

• Contributions through EU activities towards reaching commitments

Study on empowering patients with chronic diseases

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Cooperation Rare Diseases

Implementation report on Council Recommendation on Rare Diseases

• Foreseen adoption End July 2014 • New Commission expert group on rare diseases replacing the European Union Committee of Experts on Rare Diseases

Implementation report on the Commission Communication on Alzheimer’s disease and dementia

• Foreseen adoption September2014 • Outcomes of the initiative, including : Joint Action, Joint Programming initiative on neurodegenerative diseases (7th Framework Programme) and the European Innovation Parntership on Active and Healthy Ageing 7

Cooperation Health Threats, Joint procurement

Joint Procurement Agreement (JPA)

• The JPA sets the frame and the modalities for the organisation of joint procurements for medical countermeasures under Decision 1082/2013/EU. • • 15 Member States and the Commission signed the JPA so far – 8 Member States signed letters of intent to confirm their willingness to participate to the JPA once their national approval process would be finalised.

The first meeting of the JPA Steering Committee will be held on 22-23 September to discuss interenal rules of procedure and which medical countermeasure Member States want to purchase jointly.

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Cooperation Health Threats, HIV/AIDS

EU policy framework on HIV/AIDS

• 14 March: publication of prolonged 'Action Plan on HIV/AIDS in the EU and neighbouring countries: 2014 2016' to provide continuity of EU action beyond 2013 • • • Key areas: Politics, and policies, Prevention, Priority regions, Priority groups, Improving knowledge, and Monitoring and evaluation; "increased focus" to actions addressing 'stigma & discrimination', 'treatment as prevention', 'integrated prevention and treatment for HIV/AIDS and co infections' External evaluation of Communication (to be completed soon) to inform development of potential options for future policy framework 9

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Cooperation Health Threats, AMR

Recent developments: • • Transatlantic Taskforce on AMR (TATFAR) progress report – published May 2014 2nd Council recommendation implementation report on Patient safety, including the prevention and control of healthcare-associated infections – published June 2014 (part of Patient Safety Package) Upcoming events: • AMR Action Plan Progress report (foreseen Sept 2014) • 3rd Council recommendation implementation report on the prudent use of antimicrobial agents in human medicine (first half 2015) 10

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Cooperation Health threats, Seasonal influenza

Recent developments:

• • Commission staff working document on state of play on implementation of the Council Recommendation on seasonal influenza vaccination (2009/1019/EU) Presentation of the report to the Council Working Party on Public Health (8 May 2014) • • The report revealed a number of shortcomings (e.g. lack of data and poor data quality on vaccination coverage) and presented ideas for improvement at both the MS and EU level Next report on the implementation of the Recommendation due for 2015 11

Cooperation Substances of Human Origin

Action Plan on Organ Donation and Transplantation

• Mid-term review published on 25 April; • • Main results: -Increase in both organ availability and the number of transplantations, but significant differences between Member States, and persisting long waiting lists; -Recognition of donor transplant coordinators; -Increase in deceased donation rates; -Living donor transplant programmes adopted in most MS Focus for 2014-2015: -EU level : living donation and the international exchange of organs -National level : maintain/increase efforts on donor transplant coordinators, to introduce quality improvement programmes, to improve communication skills of health care professionals and public authorities and to evaluate post-transplant results. 12

Cooperation Health Systems

Communication on effective, accessible and resilient health systems

First reflections on the meaning and the way to measure: • 4 April 2014 (COM(2014) 215) • • Quality of care: usually recognised as multidimensional and includes effectiveness, safety, and patient experience. The Communication starts with effectiveness.

Access: usually comprises breadth and depth of coverage, affordability, and availability of care.

Sustainability: more than availability of funds. The Communication explores also the capacity to cope with elements of stress in the short and medium time, i.e. resilience. 13

Cooperation

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Health Systems

Country Specific Recommendations (CSRs) 2014

Increase of "health" CSRs from 11 to 16

• • • All CSRs from 2013 have been maintained, 5 new added (complexity of health reforms + general drive for continuity) In general emphasis shifted from addressing the urgent problems caused by the crisis to strengthening the conditions for sustainable growth and employment in a post-crisis economy. In this spirit, the 2014 health CSRs address concerns beyond the fiscal aspects and are based on a more comprehensive selection criteria developed by SANCO in the recent Commission communication on health systems.

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Cooperation Health Systems

Country Specific Recommendations (CSRs) 2014

Targeted thematic areas beyond fiscal sustainability:  Better integrated models of care (pointing to hospital sector reforms / strengthening primary care / rolling out ehealth tools / revising provider payment schemes): > AT, BG, CZ, ES, FI, HR, IE, LV, MT, PL, RO and SK    Accessibility to high-quality healthcare become an explicit policy aim: > ES, LV and RO. SWDs for BG and PL also include references to this aspect

Health systems effectiveness (“quality”):

> LV and RO. SWDs for BG, LT, HU and SK include references to this aspect

Controlling public budgets for medicinal products :

> IE, ES, FR with ample reference in DE SWD 15

Cooperation Health Systems

Public consultation on the Europe 2020 Strategy

Objective of the consultation:

informing the review of the Europe 2020 strategy and seeking views on its further development.

Target groups:

all actors, stakeholders and organisations that have an experience with and/or a view on the Europe 2020 strategy.

Access to the public consultation:

Your Voice in Europe or Europe 2020 website Period of the public consultation: 5 May-31 October 2014 Next steps: based on the outcome of the public consultation, the Commission will make proposals for the further development of the Strategy in early 2015.

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Cooperation Health Systems

European Reference Networks (ERN) art.12 Cross Border Health Care Directive. Entry into force 27 May 2014

• implementing legislation on criteria for ERNs and healthcare providers wishing to join a Network Decision (2014/286/EU), and • • • procedure for establishment and evaluation of ERNs: Decision (2014/287/EU) First ERN Conference (23.06.14) and awareness campaign 2014 2015.

Call for European Reference Networks in 2015

Report on patient safety, including the prevention and control of healthcare associated infections.

• Adopted 19 June • Joint Action European Union Network for Patient Safety and Quality of Care, PaSQ (2012-2015) 17

Cooperation Health Systems, HTA

Health Technology Assessment Network 2nd meeting: Brussels, April 2014

• HTA Strategy  Overall support to - Synergies between joint HTA work at EU level and national HTA activities to avoid duplication of assessments - HTA integration in the life cycle approach of health technologies; from R&D to market access, post marketing surveillance and re-evaluation - Synergies between regulatory and HTA requirements, before and after marketing authorisation • Longer term: need for permanent mechanism to maintain cooperation  EMA as a possible host • Rapid assessment of new pharma products on hepatitis C: several HTA bodies working on it  high potential for doing the assessment jointly. 18

Cooperation Health Systems - eHealth

eHealth Network - Athens, May 2014

• First discussion on guidelines for ePrescription - Adoption expected in November 2014 • Multiannual work programme 2015-2018. Focus on - interoperability and standardisation, - exchange of knowledge, - implementation of EU guidelines (patient summary, ePrescription), - global cooperation • Request to co-finance infrastructure for 4 services through Connecting Europe Facility (€38,2 Mio) - patient summary, ePrescription, telematics for the European Reference Network, patient registries. - DG CONNECT and MS in the lead for the decision for 2015 and beyond 19

Cooperation Health Systems – Expert Panel

Expert Panel on effective ways on investing in health – Opinions adopted:

• A frame of reference in relation to primary care with a special emphasis on financing systems and referral systems (after a public consultation) • • Criteria to identify priority areas when assessing

the performance of health systems

Assessment of the study “Evaluation of public- private partnerships in health care delivery across the EU” 20

Cooperation – EIP on Active and Healthy Ageing

Scaling-up Good Practices Supporting Policy A Scaling-up Strategy

Paper: provides a practical guide on the key success factors and lessons learnt, based on evidence collected from EIP Reference Sites. Contribution to Social Protection Committee's

Report on Long-term

Care: EIP Good Practices provided some of the evidence on existing EU innovative practices

Cooperation Health Information

• • Towards the establishment of a European Research Infrastructure Consortium (ERIC) :

Support from the Third Health Programme

• Open call for one project to prepare the transition towards a sustainable and integrated EU health information system (deadline : 25 September 2014) • Close connection with the Commission Expert Group on Health Information (EGHI)

Support from Horizon 2020

• Open call for design studies (deadline : 2 September 2014) 22

Financing

Health Programme 2014-2020

• Adopted in March • • Annual work plan for 2014 adopted on 26 May 2 Calls for proposals published on 6 June: dealine 25 September 2014: -Projects on chronic diseases (prevention, early diagnosis and screening professional reintegraion), adherence frailty and multi chronic conditions, statistical data on medicinal product, health monitoring, healthcare associated infections -Grants to the functioning of non-governmental bodies 23

Financing European Structural and Investment Funds (ESIF) 2014-2020

Final phase of negotiations with Member States

• The strategic documents (28 Partnership Agreements – PAs) for all Member States to be adopted by October.

9 PAs already adopted (LV, LT, PL, SK, DE, EE, DK, CY, EL) • About 500 Operational Programmes (OPs): Several OPs for each MS with different thematic or regional focus. The OPs are to be adopted in the course of this year. Health represented in many OPs (such as on human resources, innovation, infrastructure or regional development).

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Financing Mapping of ESIF investments in health

Preliminary assessment of available documents : • • • Investments to support transition from hospital care to community based and primary care (including new or reorganised infrastructure) and better access to healthcare: - Most frequently in the Baltics and Member States (MS) and regions in the east and south of the EU.

Investments in health research and innovation, including in particular with a view to foster innovation in active and healthy ageing - Most frequently in MS and regions from the north and west of the EU.

Investments in e-health, health prevention and promotion, or health workforce - In most, albeit not all, MS.

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Financing

Joint Actions in the Third EU Health Programme

New Rules:

• Nomination of competent authorities OR other bodies to participate in one or more joint action(s).

Deadline 16 September 2014.

• • • • • Levels of co-financing aligned with other mechanisms: up to 60% of eligible costs incurred (80% in cases of exceptional utility).

Overall budget EUR 18 593 000 8 Joint Actions MS consulted in the planning of all actions in the Programme (through the Programme Committee) All EU Member States and countries participating in the Programme are benefitting from JAs 26

Financing

Joint Actions in the Third EU Health Programme (1)

Nutrition, overweight and obesity related health issues, with particular attention to childhood obesity

• • EUR 1,2 Mio; expected start : 1Q 2015 Main activities:capacity building, identification of comparable data and methodologies, reflection on monitoring national policies, guidelines to support policies and communication.

Improvement of HIV/AIDS and co-infection prevention and treatment

• • EUR 3 Mio; expeced start : 1Q 2015 Main activities:focus on East and Southern European countries, promotion of integration of care (HIV/AIDS and co-infections, prison health) improve use of evidence for drug prevention scale up drug treatment and harm reduction, guidance on the use of funding mechanisms, discrimination.

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Financing

Joint Actions in the Third EU Health Programme (2)

Alzheimer's disease and dementias

• • EUR 1,5 Mio; expected start : 1Q 2015 Main activities: follow-up to ALCOV, improved post diagnostic services and care pathways, assessmen of the use of medicinal products, health of family carers, qualificaion of the personel, availability and quality of day-care homes.

Emerging threats caused by new pathogens

• • EUR 3,5 Mio; expeced start : 1Q 2015 Main activities: follow-up to QUANDHIP, identification of pathogens, rapid mechanisms for sample sharing, confirmation of laboratory diagnosis, quality assurance for detection of bioterrorism risk, capacity building, biodiverse repository of reference materials, interoperability with research and public health networks.

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Financing

Joint Actions in the Third EU Health Programme (3)

Medical Devices

• • EUR 203 000; expected start : 1Q 2015 Main activities: development of best practice, training and knowledge and resource sharing in the operation of the medical devices legislation, with a focus on notified bodies, assessment of clinical studies, vigilance system and market surveillance.

eHealth

• • EUR 2,4 Mio; expeced start : 1Q 2015 Main activities: guidelines on ePrescription, use of medical information for public health and research, support to the eHealth action plan 2012-2020, interoperability, use of eHealth in health promotion and disease managment.

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Financing

Joint Actions in the Third EU Health Programme (4)

Rare Diseases

• • EUR 2,5 Mio; expected start : 1Q 2015 Main activities: information provision, codification, European reference networks, sharing of expertise and support to the expert group on rare diseases.

Blood transfusion and tissue and cell transplantation

• • EUR 2,5 Mio; expeced start : 1Q 2015 Main activities: support to national vigilance systems, traceability and implementation of the Single European Code for tissues and cells, training of inspectors.

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