EUROPEAN COMMISSION

Brussels, XXX

[...](2020) XXX draft

COMMISSION STAFF WORKING DOCUMENT

Accompanying the document

Report from the Commission to the European Parliament and the Council

Implementation of the third programme of EU action in the field of health in 2017

Table of Contents

JOINT ACTIONS    

1.    20122202 — Mental Health and Well-being (MH-WB) Joint Action    

2.    20122103 — The impact on maritime transport of health threats due to biological, chemical &radiological agents, including communicable diseases (SHIPSAN ACT Joint Action)    

3.    20122201 — Joint Action Health Workforce Planning and Forecasting (JA EUHWF)    

4.    20112102 — Achieving Comprehensive Coordination in Organ Donation throughout the European Union (ACCORD)    

PROJECTS    

1.    20121205 — Innovating care for people with multiple chronic conditions in Europe (ICARE4EU)    

2.    Stimulating Innovation Management of Poly-pharmacy and Adherence in the Elderly (SIMPATHY)    

3.    20121211 — Benchmark comprehensive cancer care that provides interdisciplinary treatment for patients, and yield examples of best practice in comprehensive cancer care (BENCH-CAN)    

4.    20121217 — NEW e-HEALTH SERVICES FOR THE EUROPEAN REFERENCE NETWORK ON RARE ANAEMIAS (e-ENERCA)    

OPERATING GRANTS    

1.    742885 — Alzheimer Europe (AE SGA 2017)    

2.    748399 — A Plan for Action: Ensuring Equitable, Affordable and Responsibly Used Medicines in the European Union (HAI_FY2017)    

DIRECT GRANT WITH INTERNATIONAL ORGANISATIONS    

1.    20165401 (European Observatory on Health Systems and Policies) and 20165303 (OECD) on the State of Health in the EU    

2.    20155103 Re-HEALTH: ‘Support Member States under particular migratory pressure in their response to health-related challenges’    

3.    20145401 Ad hoc cooperation with the CoE on specific matters related the improvement of safety and quality of blood components and tissues and cells for human application and dissemination of best practices (Council of Europe/EDQM — DGA)    

CALLS FOR TENDERS    

1.    20147308 — Study on cross-border health services: potential obstacles for healthcare providers    

2.    Services contract: 20146101 — Costs of unsafe care and cost-effectiveness of patient safety programmes report    

3.    Services contract: 20157305 — BIG DATA in Health report    

4.    Services contract: 20136101-SHAPING EUROPEAN EARLY DIALOGUES (SEED) report    

5.    Services contract: 20147307 — Off-label use of medicinal products in the European Union Study report    

Background information    

HIGHLIGHTS OF CO-FUNDED ‘CROSS-CUTTING’ AND ‘OTHER’ ACTIONS    

1.    Dissemination activities carried out in 2017    

2.    Other Actions    

Background information    

IMPLEMENTATION OF ANNUAL WORK PROGRAMME 2017    

CALLS FOR PROPOSALS    

Project grants    

European Reference Networks (mono-beneficiary grants)    

Operating grants    

JOINT ACTIONS    

DIRECT GRANT AGREEMENTS AND PRESIDENCY CONFERENCES    

PROCUREMENTS (SERVICE CONTRACTS)    

OTHER ACTIONS    

DETAILED OVERVIEW OF THE REPORTING YEAR 2017    

Funding per thematic priority and financial instrument    

Introduction

This Commission staff working document accompanies the report on the implementation of the third health programme 2014-2020 in 2017. While the report provides an overview of all the actions funded under the annual work programme for 2017 (2017 AWP) and key co-funded health policy initiatives, including ones to implement EU health legislation, this document showcases the key results of actions co-funded under previous financing decisions.

It includes actions on overarching themes such as mental health, care coordination, European Reference Networks, cancer, access to care, health security and patient safety. Lastly, it provides comprehensive figures and statistics on the health programme’s 2017 operating budget, and lists all co-funded initiatives and contracts by programme objective, type of action and type of beneficiary.

Highlights of initiatives ending in the reporting year — examples of the programme’s results

Several initiatives co-funded under the second health programme 2008-2013 ended in late 2016 and 2017 and produced important results that were taken up and built on at national or EU level — some examples are described in this document. More information about these and other projects or joint actions can be found in the health programme database managed by the Consumers, Health, Agriculture and Food Executive Agency (Chafea) 1 (this database covers actions co-funded under the second and third health programmes).

JOINT ACTIONS

Objective 1. Promote health, prevent disease and foster supportive environments for healthy lifestyles

1.20122202 — Mental Health and Well-being (MH-WB) Joint Action

Background information

According to the World Health Organization's (WHO) estimates, mental disorders affect 1 in 4 people at least once in their lifetime and affect more than 10% of people in the EU in any given year. Neuropsychiatric disorders are the second leading cause of disability-adjusted life years (DALYs) in the WHO European Region, accounting for 19.5% of all DALYs.

According to Eurostat, suicide is a significant cause of premature death in the EU, with over 50 000 deaths a year, and 9 of the 10 countries with the highest rates of suicide in the world are in the European Region. Mental health problems are also associated with productivity losses, with substantial costs to the economy. On the other hand, evidence increasingly shows positive mental health and well-being to be a key factor in social cohesion, economic progress and sustainable development in the EU.

Brief description

The main objective of this joint action was to help promote mental health and well-being, prevent mental disorders and improve care and social inclusion for people with mental disorders in Europe.

National and European working groups evaluated Member State and EU-level progress in this area through a SWOT analysis; a literature review; questionnaires and interviews.
This research and literature review, carried out in collaboration with EU agencies, the WHO and other international organisations led to recommendations for action to improve the effectiveness of mental health policies. 

A final conference was organised to endorse Member State and EU recommendations and to underline EU commitment for follow-up actions. Close collaboration was established with other European mental health initiatives, and a strategy was developed to create a structured cooperation in mental health policy in Europe in the future.

Specific results

The joint action developed a commonly endorsed framework for action addressing: (a) the promotion of mental health in workplaces and schools; (b) promoting action against depression and suicide; (c) developing community mental health care; and (d) promoting the integration of mental health in all policies.

These outputs were further built on by the Mental Health Compass 2  which, in parallel, monitored the mental health and well-being policies and activities of EU countries and non-governmental stakeholders and identified European good practices in mental health in the following areas:

·Preventing depression & promoting resilience

·Better access to mental health services

·Mental health at work

·Mental health in schools

·Preventing suicide

·Providing community-based mental health services

·Developing integrated governance approaches

The collected best practices have been submitted to the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases 3 for interested Member States to identify the ones that they would like to take up and implement in the future.

The joint action's results are available on the project website 4  and in Chafea’s health programme database 5 .

Objective 2. Protect EU citizens from serious cross-border health threats

2.20122103 — The impact on maritime transport of health threats due to biological, chemical &radiological agents, including communicable diseases (SHIPSAN ACT Joint Action)

Background information

The EU SHIPSAN ACT joint action brought together competent authorities from 26 countries and industry representatives to strengthen and integrate sustainable EU-level mechanisms to protect the health of sea travellers and crewmembers and prevent the cross-border spread of diseases.

Its specific objectives were to: (i) produce a report on the risks and consequences of chemical, biological, radio-nuclear (CBRN) events in all types of ships; (ii) improve the quality of inspections; (iii) increase port health staff and crew competencies; (iv) develop an outline for a risk assessment tool for occupational and public health; (v) develop guidance on health threats due to chemical/radiological agents; and (vi) to maintain and update SHIPSAN information tools.

Brief description

The action focused on the prevention, identification and assessment of CBRN-related cross-border health threats and on possible links with existing response mechanisms.

Methods included literature reviews, surveys and site visits, leading to a comprehensive needs assessment exercise. Focus groups and expert opinions were also used in order to reach a consensus among the different categories of stakeholders.

Dedicated working groups developed preparedness guidelines and training material, and coordinated ship inspections were conducted in line with European standards. Information was shared among participating countries on routine ship inspections (IHR - ship sanitation certificate (SSC)), ship-associated events and response measures using web-based databases. The pool of trainers was updated and a training programme involving face-to-face learning, e-learning, on-the-job training and blended learning was developed for public health officers and the industry.

Specific results

The SHIPSAN ACT joint action’s main deliverables include the European manual for hygiene standards and communicable diseases surveillance on passenger ships, the SHIPSAN information system (SIS), training courses, guidelines and risk assessment tools.

·The European manual (second edition) 6 incorporates hygiene standards based on EU legislation and brings together best practice guidelines for passenger ships sailing within European waters.

·The SHIPSAN ACT web-based information system 7  contains: (a) a communication network platform for port-to-port and port-to-national authority communication; (b) an information system for recording and issuing ship sanitation certificates under the International Health Regulations 2005 for all types of ships sailing in the EU [a total of 364 port health officers from 20 EU countries are registered to the information system and issued more than 14 614 ship sanitation certificates (as of 8 June 2018)]; (c) a database for recording inspections conducted according to the European manual (303 inspections from 2011 to 2017); and (d) a database for storing the maritime declarations of health submitted to Member States' 'national single windows'.

·The joint action delivered e-learning and face-to-face 8  training courses for ship operators, ships’ officers and crew and port health officers. The pool of trainers included 90 subject matter experts from 20 countries, and a total of 1 162 users signed up to the e-learning platform. The partners gave 11 live webinars with >500 viewers from 21 EU countries and 12 non-EU countries. Training courses using the SHIPSAN ACT training materials were organised in Spain, Finland and Norway after 2016. In 2018, inspectors from the Netherlands started recording SSC under the International Health Regulation (IHR) in the SIS.

The good practices on preparedness and response developed by SHIPSAN ACT JA and AIRSAN PJ 9  have been extended to cover all three points of entry: air, maritime and ground transport, through the new HEALTHY GATEWAYS 10  joint action funded under the AWP 2017.

The action's results are available on the project website 11  and in Chafea’s health programme database 12 .

Objective 3. Contribute to innovative, efficient and sustainable health systems

3.20122201 — Joint Action Health Workforce Planning and Forecasting (JA EUHWF)

Background information

Health workforce issues were put on the EU agenda by the Green Paper on the European Workforce for Health of the European Commission (2008) and the Commission Communication (2010/0682, final 23 November 2010). Member States also requested that investing in Europe`s health workforce of tomorrow be included in the Council Conclusions of 7 December 2010.

Eighteen countries participated on this joint action, together with international organisations and EU-wide health professionals’ organisations.

Brief description

The main objective of the joint action on health workforce planning and forecasting (JA EUHWF) was to provide a collaboration and exchange platform to better prepare Europe’s health workforce for future challenges and to help countries improve their planning processes.

The joint action's objectives included: (i) a better understanding of terminology; (ii) better monitoring of health workforce issues through access to recent data; (iii) updating information on mobility and migration trends in the EU; (iv) guidelines on quantitative and qualitative health workforce planning methodology; (v) increasing quantitative and qualitative planning capacity; (vi) estimating future skills and competencies needed in the health workforce; (vii) setting up a cooperation platform to find possible solutions to the expected health workforce shortages; and (viii) increasing the impact of health workforce planning and forecasts on policy decision-making.

The joint action's two main methods were knowledge sharing and improvement actions.
(1) On knowledge sharing, a collaboration platform was created to enable dialogue between national authorities, experts and stakeholders. The governance structure, procedures of communication, collaboration, outputs and outcomes of the joint action were included in this platform.
(2) On improvement actions, health workforce data (especially on mobility) were analysed and assessed. The use of pilot studies, as well as quantitative and qualitative planning and forecasting tools, led to improved capacity in several of the participating Member States.

Specific results

National competent authorities increased their knowledge, improved their tools and strengthened their workforce planning. The action's key deliverable — the final Guide on health workforce planning and forecasting helped participating Member States to reduce the gaps between the expected needs and the expected supply of health professionals. The national competent authorities also re-designed education and training pathways, both in initial and continuous education, to ensure enough healthcare professionals with the right skills to meet their needs.

The action's results are available on the project website 13  and in Chafea’s health programme database.

Objective 4 — Facilitate access to better and safer healthcare for Union citizens

4.20112102 — Achieving Comprehensive Coordination in Organ Donation throughout the European Union (ACCORD)

Background information

According to the data provided by the Council of Europe's European Committee on organ transplantation (CD-P-TO), more than 34 024 patients received transplants in the EU in 2017 14 . However, this is not enough to meet patients' transplantation needs. The Council of Europe data also reveal the extreme disparities in organ transplantation between EU countries.

The overall objective of the ‘Achieving comprehensive coordination in organ donation throughout the European Union’ (ACCORD) joint action was to unleash Member States' full potential in the field of organ donation and transplantation. To achieve this, the action aimed to improve the cooperation between the national competent authorities in line with the requirements of Directive 2010/53/EU ('the Directive') and the accompanying action plan on organ donation and transplantation (2009-2015) to strengthen cooperation between Member States.

Brief description

The joint action had three specific objectives:

1.To improve Member States' information systems on living organ donation by providing recommendations on the design and management of living donor registries (LDRs) and by introducing a model for supranational data sharing.

2.To facilitate the cooperation between critical care professionals and donor coordinators, to optimise donation from the deceased.

3.To provide practical help to EU countries to share knowledge, expertise and tools specific to the Directive and action plan in the form of specific comprehensive exchange protocols (twinnings).

Specific results

Training activities, exchange of best practices and networking support in all three fields have delivered concrete results:

·Several Member States have already started to create their national LDRs (or modify their existing LDRs) taking into account the ACCORD standards and recommendations —  Spain, for example, with more than 70 hospitals involved.

·The joint action's twinning projects have improved access to transplantation, and increased quality and safety standards across the EU.

·Practical tools include: (i) auditing and accreditation manuals for transplant centres; (ii) training models for auditors; and (iii) e-learning tools for abdominal organ procurement surgeons. These were assessed by the national competent authorities and adapted as necessary before being rolled out.

·Finally, ACCORD has helped the consistent application of Directive 2010/53/EU and the related action plan across the EU through its concrete assistance to Member States.

The action's results are available on the project website 15  and in Chafea’s health programme database 16 .

PROJECTS

Objective 1. Promote health, prevent disease and foster supportive environments for healthy lifestyles

1.20121205 — Innovating care for people with multiple chronic conditions in Europe (ICARE4EU)

Background information

Some 50 million Europeans live with multi-morbidity and their numbers are likely to grow. These people have complex health problems and need ongoing care from multiple care professionals and organisations. Policymakers all over Europe are alarmed by the challenge this poses to their health systems and social services. Consequently, many have put multi-morbidity high on their policy agenda.

The European Commission has funded the ICARE4EU project to help policy makers learn from new approaches to integrated care, and to share experiences of innovative practices in European countries.

Brief description

ICARE4EU analysed current innovative EU approaches to multidisciplinary care for people with multiple chronic conditions. Expert organisations from 30 European countries provided information on the characteristics of their care programmes for patients with multi-morbidity.

They provided information on, for example: (i) the target groups; (ii) the disciplines involved; (iii) the procedures and financing of long-term care; and (iv) the way in which patients and informal carers are actively involved. Country-level information on healthcare systems and their characteristics was also collected. As a result, the key characteristics for successful management and implementation strategies were identified.

Specific results

The ICARE4EU project delivered five policy briefs to help policymakers in European countries adapt their health systems to better meet the needs of people with multi-morbidity.

The policy briefs identify actions that can improve the design of integrated care for people with multi-morbidity — including innovative care models and effective implementation — and answer the following questions:

-How to improve care for people with multi-morbidity in Europe?

-How to make their care more patient-centred?

-How to strengthen the related financing mechanisms?

-How can e-Health improve their care?

-How to support integration to promote care for people with multi-morbidity?

The action's results are available on the project website 17  and in Chafea’s health programme database 18 .

2.Stimulating Innovation Management of Poly-pharmacy and Adherence in the Elderly (SIMPATHY)

Background information

According to the ‘Err is Human’ report 19 , medication is the most common and the third most costly healthcare measure. In addition, up to 11% of all unplanned hospital admissions are attributable to drug-related harm.

The SIMPATHY (Stimulating innovation management of poly-pharmacy and adherence in the elderly) consortium explored how healthcare management programmes can improve medicines safety and prevent patient harm. To ensure the appropriate use of poly-pharmacy (i.e. multiple medications for the same patient), programmes should be developed in partnership with patients, as shared decision-making on medication improves patient adherence and medicines-related outcomes.

Brief description

The SIMPATHY initiative involved case studies in a range of healthcare environments, including at the reference sites of the European Innovation Partnership on active and healthy aging (EIP-AHA). This provided a framework, and more importantly, baseline data for an EU-wide benchmarking survey of poly-pharmacy and non-adherence management strategies.

This included innovative multidisciplinary models, using the professional expertise of pharmacists and physicians to reduce inappropriate poly-pharmacy and support patients with long-term conditions. A set of change-management approaches and tools, tailored to different situations, were also developed to help policymakers, regulators, health service providers, and other stakeholders improve current practice by implementing organisational change.

Specific results

The SIMPATHY case studies, benchmarking survey and literature review identified effective poly-pharmacy management programmes in the EU, but also underlined that they are too few in number. The project also highlighted that patients consider inappropriate poly-pharmacy to be an important issue that needs to be addressed.

The SIMPATHY report calls for EU countries to work together to manage and prevent inappropriate poly-pharmacy and improve medicines adherence and patient outcomes through a coordinated and collaborative change-management approach.

The consortium delivered five key recommendations:

1.Use a systems approach with multidisciplinary clinical and policy leadership.

2.Create a culture that encourages and prioritises the safety and quality of prescriptions.

3.Empower patients by giving them a central role in medication decisions.

4.Use data to drive change. 

5.Adopt an evidence-based approach.

Adopting these recommendations will help EU countries meet the WHO global challenge to improve medication safety, of which poly-pharmacy is an essential element.

The action's results are available on the project website 20  and in Chafea’s health programme database 21 .

3.20121211 — Benchmark comprehensive cancer care that provides interdisciplinary treatment for patients, and yield examples of best practice in comprehensive cancer care (BENCH-CAN)

Background information

The number of new cancer patients is steadily increasing but differences in EU health systems performance, as attested by substantial differences in disease and symptom free survival after primary treatment, as well as in prolonged symptom free metastatic disease, show room for improvement.

By carrying out a benchmarking exercise on cancer care in Europe, BENCH-CAN addressed the basic principles of the ‘Together for Health’ strategy. It complemented the work of the EPAAC joint action 22  on healthcare and cancer data & information and informed the Pillar B (care and cure) of the strategic implementation plan of the EIP-AHA 23 .

Brief description

The general objective of BENCH-CAN was to benchmark comprehensive cancer care and yield best practice examples in a way that contributes to improving the quality of interdisciplinary patient treatment.

To achieve this, the project addressed five action areas:

1.Collecting, comparing and aligning the standards, recommendations and accreditation criteria of comprehensive cancer care in selected European countries.

2.Reviewing and refining a benchmarking tool that can be applied to comprehensive cancer care through interdisciplinary patient treatment.

3.Piloting the benchmark tool with particular attention to operations management and best clinical practice.

4.Maximising knowledge exchange and sharing of best practice between providers of comprehensive cancer care in member states and regions.

5.Ensuring compatibility of the benchmarking tools with existing cancer care resources and services.

The action developed four benchmarking tools using both qualitative and quantitative indicators, and piloted them in nine pilot sites.

Patient experience and satisfaction were measured by the European Cancer Consumer Quality Index. Expert opinion and literature findings helped the BENCH-CAN partners identify good practices and compare their project with existing or past projects.

Specific results

·A quantitative benchmarking tool to study the relative operational efficiency and resource allocation of the participating centres. The framework comprises 141 indicators in seven categories: (i) medical activities per year; (ii) human resources input; (iii) institution's capacities and facilities; (iv) cost of human resources; (v) diagnosis and treatment costs; (vi) institution's characteristics for comparisons; and (vii) institution's financial information.

·A tool to measure patient experience and satisfaction to see whether care is responsive and personalised, which uses the European Cancer Consumer Quality Index questionnaire.

·A benchmarking manual that incorporates the benchmarking tools and sets out the processes necessary for carrying out a self-assessment.

Although targeted to comprehensive cancer care centres, it can also be used in general hospitals that provide cancer services and pathways. Above all, it is a publicly available resource 24 for all interested organisations and parties to use.

·The BENCH-CAN project also identified good practice examples of clinical practice, patient experience, and operations management processes at designated comprehensive cancer centres and interdisciplinary tumour services.

The action's results are available on the project website 25  and in Chafea’s health programme database 26 .

Objective 4. Facilitate access to better and safer healthcare for EU citizens

4.20121217 — NEW e-HEALTH SERVICES FOR THE EUROPEAN REFERENCE NETWORK ON RARE ANAEMIAS (e-ENERCA)

Background information

The e-NERCA project focused on designing, validating and implementing information and communication technology (ICT) tools to provide innovative and optimal care for rare forms of anaemia. e-ENERCA centres involved health professionals, patients, health authorities and other national stakeholders in the design, validation and implementation of new e-Health services for addressing the challenges posed by rare forms of anaemia.

Brief description

The action established the conditions for a sustainable European Reference Network (ERN), which include: (i) expanding the expertise to the whole EU; (ii) collecting patient’s data to increase the effectiveness of epidemiological surveillance; (iii) developing new e-health communication channels for better diagnosis and treatment; and (iv) establishing community reference e-platforms, embedded on ENERCA Web, to allow for easier access of e-learning and multidisciplinary advice independently from the country of practice.

The above were translated into the action's five main e-health services: (i) data from the ERN's health centres and patient’s associations, e-registry and epidemiological data; (ii) dissemination of knowledge within the ERN by updating existing information or preparation of ENERCA recommendations; (iii) medical education through training courses and e-learning applications; (iv) expert advice delivered through ICT tools, including tele-diagnosis platforms; and (v) empowering patients by improving links with patients’ associations.

Specific results

·e-Registry: an e-Health registry was developed for the epidemiological surveillance of rare forms of anaemia. This provided an inventory of relevant Centres of Expertise with the appropriate skills and knowledge to address rare forms of anaemia. It also enabled the pooling of relevant disease-related data through state-of-the-art standards.

·e-Learning and training: e-ENERCA built upon existing training tools and resources. Designed with input from e-Learning industry experts, it helped improve standards, which is essential for reducing inequalities and variations in the diagnosis, care and treatment of rare forms of anaemia.

·Telemedicine: The telemedicine platform was developed to enable clinicians and professionals to provide expertise from a distance, using virtual consultation techniques. To develop the telemedicine platform, the project analysed the legal framework of telemedicine services in the EU and clarified the legal and ethical considerations of setting up the e-ENERCA platform.

The action's results are available on the project website 27  and in Chafea’s health programme database 28 .

OPERATING GRANTS

The 17 non-governmental organisations that signed a framework partnership agreement (FPA) in 2017 29 were invited to submit their proposal for a specific grant agreement (SGA) under the 2017 AWP to cover their operational expenses for that same financial year.

The FPAs and their SGAs respond to three of the four objectives of third health programme, as follows: 13 FPA/SGA address objective 1: ‘Promote health, prevent diseases and foster supportive environments for healthy lifestyles taking into account the ‘health in all policies’ principle’; 1 addresses objective 3. ‘Contribute to innovative, efficient and sustainable health systems’; and 3 address objective 4: ‘Facilitate access to better and safer healthcare for Union citizens’.

Table 1: List of applicant organisations awarded an FPA 2017-2021 and subsequent SGAs

Throughout 2017, in line with their SGAs, the organisations achieved their objectives, produced work of value to their stakeholders and supported the Commission's health policy initiatives in their areas of activity. The work and outcomes of two organisations with a 2016 SGA — Alzheimer Europe and Health Action International — are presented below:

1.742885 — Alzheimer Europe (AE SGA 2017)

Background information

Alzheimer Europe is a non-governmental organisation (NGO) comprising 42 member associations from 37 countries. It aims to provide a voice to people with dementia and their carers, make dementia a European priority, promote a rights-based approach to dementia, support dementia research and strengthen the European dementia movement.

Brief description

The key objectives of Alzheimer Europe’s 2017 operating grant were:

·to make an inventory and comparison of care standards for care services for people with dementia and their carers and to publish the results in the 2017 'Dementia in Europe' yearbook;

·to analyse societal obligations towards people with dementia and develop a rights-based approach to dementia together with ethical recommendations;

·to further develop the European Dementia Observatory's monitoring of scientific and policy developments in the field of dementia;

·to organise an annual conference in Berlin with the motto ‘Care today, cure tomorrow’ attracting at least 500 participants; and

·to support national Alzheimer’s associations through the Alzheimer’s Association Academy's capacity-building workshops, and provide good governance to the operating grant activities.

Specific results

Seventy-three experts from 29 European countries contributed to the 'Dementia in Europe Yearbook 2017: Standards for residential care facilities in Europe', providing initial information and feedback on the draft report. The final version of the published report, approved by the participating experts, fed into a peer reviewed open access Journal in 2018.

The 2017 Yearbook was distributed to over 2 700 stakeholders, including all Members of the European Parliament, key representatives of national Health and Social Affairs Ministries, national member organisations of Alzheimer Europe and other interested stakeholders. Several other key publications were produced during the action, for example 'Dementia as a disability? Implications for ethics, policy and practice — a discussion paper'.

More information about Alzheimer Europe is available on the organisation’s website 30  and in Chafea’s health programme database 31 .

2.748399 — A Plan for Action: Ensuring Equitable, Affordable and Responsibly Used Medicines in the European Union (HAI_FY2017)

Background information

Health Action International (HAI) is a non-profit, independent, global network that aims to achieve equitable health for all.

For Europe, HAI's goal is to contribute to EU policy that promotes universal and equitable access to affordable medicines for needed treatment. HAI also supports policies and practices that ensure that medicines respond to societal challenges, are acceptably safe, and appropriately prescribed and used. Through its European network, it gives a voice to patients and consumers in decisions that will affect their health, while advocating for high levels of transparency, accountability and impartiality in all aspects of EU medicines policy.

Brief description

HAI’s work in Europe focuses on three overarching goals:

1.Increased access to needed medicines

2.Rational use of medicines

3.Democratisation of EU medicines policy

HAI’s 2015-2017 work plan was dedicated to identifying, monitoring and supporting EU policies that provide a response to persistent shortfalls in access to medicines and that are aligned with HAI’s overarching goals. HAI worked towards these goals through research, evidence-based policy analysis and intervention, training and information sharing.

Throughout 2017, HAI made efforts to improve access to essential medicines, their rational use and good governance, including by: (i) contributing to EU policies that support needs-driven innovation, equitable access to medicines in Europe and sustainable healthcare systems through research-based advocacy; (ii) advancing EU actions on the exploration of new models of medical innovation that provide solutions to cross-border health threats such as antimicrobial resistance; (iii) raising awareness about the implications of pharmaceutical promotion and enabling critical appraisal among (future) healthcare professionals; (iv) strengthening health security by supporting marketing authorisation procedures that result in the approval of safe and effective medicines; and (v) supporting good governance of medicines policy and contributing an independent voice to policy debates.

Specific results

HAI helped shape discussions on the need for more transparency on medicines pricing and R&D costs supporting civil society's demands. Throughout 2017, HAI advocated for greater transparency of clinical trial data and stronger requirements for marketing medicines authorisation and also supported research into the evidence of the benefit of oncology drugs approved by the European Medicines Agency.

HAI was involved in the activities of the Transatlantic Consumer Dialogue and brought together a coalition of 25 NGOs from Latin America and Europe that made calls on the need to safeguard access to medicines in the EU & Mercosur trade negotiations.

HAI developed publications on trade and access to medicines, and provided technical expertise to policy makers and civil society organisations.

HAI looked into the main drivers of irrational use of antibiotics, including pharmaceutical promotion, and developed a paper with recommendations in this area.

More information about the work of HAI is available on the organisation’s website 32  and in Chafea’s health programme database 33 .

DIRECT GRANT WITH INTERNATIONAL ORGANISATIONS

1.20165401 (European Observatory on Health Systems and Policies) and 20165303 (OECD) on the State of Health in the EU

Background information

In 2017, the European Commission completed the first two-year cycle of the State of Health 34  in the EU initiative and published the first country health profiles.

Jointly developed by the Organisation for Economic Cooperation and Development (OECD) and the European Observatory on Health Systems and Policies, the aim of this work was to build on the ‘Health at a Glance Europe 2016 35 ’ report to deliver, both an overarching (EU-wide) and a country-specific understanding of the major challenges facing each EU Member State.

Following the release of these country health profiles in November 2017, policy dialogues were organised with some EU countries on a voluntary basis to help them use the findings and find out more about best practices and potential policy responses.

Brief description

The purpose of this initiative was to enable mutual learning and voluntary exchange between Member States to support their evidence-based policymaking. The concise, policy-relevant profiles were based on a transparent, consistent methodology, using both quantitative and qualitative data, yet flexibly adapted to the context of each EU Member State.

Each country health profile provides a short overview of:

·health status

·the determinants of health, focusing on behavioural risk factors

·the organisation of the health system

·the effectiveness, accessibility and resilience of the health system

Specific results.

The country health profiles were accompanied by a companion report 36  with cross-cutting conclusions from the 28 EU countries. This report highlighted their shared policy objectives, such as:

·shifting towards health promotion and disease prevention;

·a stronger role for primary care;

·a rethink on fragmented service delivery;

·proactive planning and forecasting in the health workforce; and

·better patient-centred data across the EU.

Once the reports were presented to the national Health Ministries, all EU countries were invited to further discuss the findings with OECD and European Observatory on Health Systems and Policies experts.

These voluntary exchanges took place from the beginning of 2018 and helped Ministries to better understand the main challenges and develop the appropriate policy responses.

More information on the Health at Glance report is available on DG SANTE’s website 37 .

2.20155103 Re-HEALTH: ‘Support Member States under particular migratory pressure in their response to health-related challenges’

Background information

The action’s overarching goal was to improve the capacity of EU Member States under particular pressure from migration (i.e. Italy, Greece, Slovenia and Croatia) to address the health-related issues of arriving migrants. This included measures to ensure appropriate surveillance, monitoring, and early warning in case of cross-border health threats, as well as preparedness, response planning and coordination of national policies.

In particular, the project supported these national authorities in their efforts to provide and manage health services at designated reception facilities for refugees and migrants during the reception process, and strengthened the coordinated response at national and EU levels.

 Brief description

The action’s specific objectives were to:

·establish links between key reception areas and the health systems in the target countries;

·make use of the established personal health record (PHR) and the accompanying Handbook for health professionals to evaluate the health status and needs of arriving refugees and migrants;

·ensure that health assessments and preventive measures are implemented, taking into account the needs of children and other vulnerable groups; and

·ensure that data initially collected through the PHR is stored in a database so that it is available at transit and destination countries.

 Specific results:

The development of a database to manage migrant health assessment records that can then be accessed at transit and destination countries increased the knowledge on refugees and migrants’ health needs.

As a result, the refugees and migrants benefited from improved access to health service upon arrival, including health prevention, which is especially needed for women and children. This improved access to healthcare also helped reduce risks from undetected diseases and therefore to reduce cross-border health threats.

Aggregated results from the health assessments show that a substantial number of migrants were victims of torture and violence and that an equally high number had significant medical conditions.

More than 150 individuals attended the Re-Health training courses on health mediation, on the e-PHR platform use, and other health-related topics such as gender-based violence and reproductive health.

More information about Re-Health is available on the International Organisation for Migration’s website 38

3.20145401 Ad hoc cooperation with the CoE on specific matters related the improvement of safety and quality of blood components and tissues and cells for human application and dissemination of best practices (Council of Europe/EDQM — DGA) 

Background information

To increase safety for patients receiving tissues and cells, all professionals involved in the donation cycle’s steps must have clear and harmonised technical guidance to ensure the safety and quality of these tissues and cells. This includes those identifying potential donors, the transplant coordinators managing the process of donation after death, the professionals working in bone marrow and cord blood collection centres, those in tissue establishments processing and storing tissues and cells, and the inspectors auditing any of the establishments and organisations responsible for procedures involving blood, tissues and cells.

Owing to its mission, expertise, outreach and structure, the Council of Europe can significantly contribute to the dissemination of best practices in this area and reach out to different audiences in the EU as well as in countries from/to which EU Member States regularly import/export human substances.

Brief description

This action involved four main activities:

1.A Guide to the quality and safety of tissues and cells for human application (hereinafter, the TC Guide). The objective was to develop and disseminate common European quality and safety standards for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, including gametes and embryos, which will be published in future editions of the TC Guide.

2.A blood-proficiency testing scheme (B-PTS) programme. The aim was to organise proficiency testing scheme (PTS) studies for European blood establishments (BE). Participation in PTS studies can provide testing laboratories of European BE with an objective means of assessing and demonstrating the reliability of the data they are producing. The B-PTS activity will enable testing laboratories of the European BE to maintain and improve their performance.

3.A blood quality management (B-QM) programme involving on-site training courses, visits and audits in BE, as well as training course(s) for quality managers from BE. This programme aimed to support BE in implementing/developing their QMS.

4.A technical workshop to: (i) collect evidence on the implementation of the EU Directives and the CoE guidelines from the experience of the B-PTS, B-QM activities; (ii) develop Blood, Organ and TC Guides; and (iii) formulate recommendations to support possible future EU regulatory and technical decisions.

Specific results:

The third edition of the TC Guide was published in August 2017 39 .

Six B-PTS took place 40  using the same methodology.

Each study comprised the following steps: recruitment of the participants, preparation of a study outline, performance of a feasibility study if necessary, procurement of material, preparation of samples, invoicing and distribution of the samples, protocol to the participants, experimental phase, statistical evaluation, and reporting to the participants.

Each study was followed up with dissemination and promotional activities, as well as a comprehensive evaluation to review and improve upon the exercise.

Two on-site training/assessment schemes were developed under the B-QM programme: (1) the B-TVs (blood training visits); and (2) the B-MJVs (blood mutual joint visits). Their purpose was to provide BEs with tailor-made and effective advice. These visits were performed by peer-experts in European BEs.

More information about this action is available on the Council of Europe’s website 41 .

CALLS FOR TENDERS

1. 20147308 — Study on cross-border health services: potential obstacles for healthcare providers

Background information

Although EU legislation aims to facilitate cross-border health services, in practice, healthcare professionals still face various (potential) obstacles. These are the result of dissimilar rules between Member States, various (cross-sector) administrative requirements, language barriers, and even challenges in the recognition of qualifications process.

More specifically, this study had the following three objectives:

1.to identify specific and cross-sector national requirements for healthcare providers, when providing cross-border health services;

2.to identify the main barriers to delivering cross-border health services by considering how the requirements apply in practice; and

3.to provide an estimate of the amount of resources a healthcare provider would have to invest in order to meet the various requirements.

Brief description

The study investigated five scenarios of cross-border health services provision.

·Scenario 1: a General Practitioner (GP)/family doctor wishing to set up a practice in another Member States (MS) to offer standard GP services to patients.

·Scenario 2: A GP wishing to offer online consultations and ePrescriptions to patients (both private patients, and also patients covered by or claiming reimbursement from the public healthcare system) in one MS while being established in another MS.

·Scenario 3: A physiotherapist wishing to establish themselves as an independent practitioner offering physiotherapy services in another MS.

·Scenario 4: A medical services laboratory in one MS offering diagnosis services (for example, standard blood sample analysis) in another MS.

·Scenario 5: A hospital wishing to open a subsidiary branch in another MS.

Each of these scenarios were analysed for 10 different MSs: France, Germany, Italy, Latvia, Malta, the Netherlands, Poland, Slovenia, Sweden, and the United Kingdom. The analysis of the requirements that cross-border providers needed to fulfil in these 10 EU countries provides a sound basis for identifying likely barriers to providing health services in different types of healthcare systems and legislative environments within the EU.

Specific results

The study concluded that the requirements that only apply to cross-border providers (referred to in the study as ‘additional requirements’) mainly concern individual medical professionals. For example:

·recognition of qualifications (GPs, physiotherapists and professionals running a medical laboratory);

·language requirements (GPs, physiotherapists and professionals running a medical laboratory); and

·additional requirements upon registration with regulatory bodies (e.g. additional supporting documents and certified translations).

The main obstacles identified were:

·Language requirements: all selected Member States have language requirements for cross-border GPs, physiotherapists, and professionals running a medical services laboratory.

·High costs associated with providing the required supporting documents — and particularly the certified translations of these documents — in the ‘recognition of qualifications’ process and/or upon registration with a regulatory body.

·Registration with regulatory bodies: the registration process is crucial, since most regulatory bodies are in charge of delivering licences to practice. Although national providers also need to register with the regulatory body, additional requirements are often imposed on cross-border providers.

·Unfamiliarity with the specifics of the healthcare system in a Member State: compared to national providers, cross-border providers may experience more practical obstacles in finding the relevant information and navigating through the system. This potential obstacle is likely to be even bigger in Member States with a decentralised healthcare system.

More information about the study is available on DG SANTE’s website 42 .

2.Services contract:    20146101 — Costs of unsafe care and cost-effectiveness of patient safety programmes report

Background information

Given the growing importance of patient safety for health systems, and above all for patients, it was necessary to assess the impact of patient safety measures and to develop priorities for action. The economic burden associated with unsafe patient care required more action, particularly given the recent economic crisis.

The study’s three main objectives were:

1.to provide a comprehensive picture of the financial impact of poor patient safety, including poor prevention and control of healthcare-associated infections, on EU health systems;

2.to identify cost-effective patient safety programmes implemented in the EU/EEA Member States and analyse their success factors; and

3. to assess the cost-effectiveness and the efficiency of investment in patient safety programmes.

Brief description

A mix of methods was used to answer the research questions. The team conducting the study carried out a systematic literature search, as well as desk research into the evidence on the prevalence and costs of adverse events and on cost-effective patient safety programmes. It also consulted an expert panel to complement results from literature where necessary. Finally, it developed an econometric model to calculate the economic burden of adverse events and the cost-effectiveness of patient safety programmes.

Specific results

The literature on unsafe care clearly demonstrated the substantial burden of adverse events. The general prevalence of adverse events range between 4% and 17% of all patients. Calculations based on two European references showed direct costs to the public healthcare sector to be around EUR 21 billion or 1.5% of Member States’ health expenditure in 2014.

The literature search on cost-effective patient safety programmes yielded a high number of publications. These identified the characteristics of the most promising interventions to be: (i) the use of multi-methodological approaches; and (ii) the involvement of employees of all professions. The origin of the intervention, i.e. whether it was adapted from existing programmes or developed in-house, had no bearing

The study finally established a basic econometric simulation model calculating costs, effects, cost-effectiveness ratios and savings from selected patient safety programmes. The results were overwhelmingly positive. Estimated savings (EU-wide) range from EUR 300 million for a programme to reduce several healthcare-associated infections, to savings of about EUR 2 billion for a programme to reduce pressure ulcers or of around EUR 6 billion for an electronic system to prevent adverse drug events.

This report also provided recommendations on which patient safety programmes to prioritise, based on identified studies. Such prioritisation must consider a number of key indicators, such as the prevalence of the adverse event, the relevance of (easily preventable) adverse events, and the (established) cost-effectiveness of the available patient safety practices.

More information about the study is available on DG SANTE’s website 43 .

3.Services contract: 20157305 — BIG DATA in Health report

Background information

The European Council called for action on identifying sectoral priorities for research and innovation with the greatest potential for social and economic benefits in the data economy. The European Council has also emphasised the importance of the digital economy, recognising its high potential as well as the need for a strong data value chain in Europe. Both the European Council and Member States (MS) are willing to take the necessary steps to improve data innovation, especially given the exponential increase in data, highlighting that making data accessible, assessable, reusable and interoperable is the key to innovation.

The purpose of the study was therefore to explore how to use big data in health to improve health and health outcomes of people in the EU. The study also aimed to identify practical examples of using big data in health and develop recommendations for their implementation.

Brief description

The study’s specific objectives were:

-to provide a list of examples of big data in public health, telemedicine and healthcare already being used that could be introduced in the EU MS;

-to propose the 10 biggest big data-related priorities for the practice of public health, telemedicine and healthcare, where a specific action could be developed, in particular at EU level;

-to develop a list of policy recommendations as a guideline for developing a big data value chain in the EU;

-to conduct a SWOT analysis on the feasibility of implementing the proposed policy actions; and

-to organise an expert workshop, with all interested parties (national public administrations, patients/citizens, health professionals, service providers, healthcare payers and industry).

Specific results

The suggested recommendations were explicitly from a public health perspective, aiming to improve the health of people in the EU as well as the performance of MS’s health systems. They covered three four broad areas:

·To increase understanding and awareness, the study recommended: (i) an overarching communication strategy to convince the public of the added value of big data in health; and (ii) support to health workers to use this data.

·On the data sets and their analysis, the study recommended: (i) facilitating the open use and sharing of big data in health without compromising patients’ rights to privacy and confidentiality; (ii) using new and innovative analytical methods; and (iii) developing standards.  These factors will simplify the application of big data in health and improve interoperability.

·On governance and financing, the study recommended appropriate governance mechanisms to ensure: (i) secure and fair access to and use of big data for health research; (ii) the cost-effectiveness and sustainability of the funding models; and (iii) clear and well-enforced legal and privacy rules for big data in health.

More information about the service contract is available on DG SANTE’s website 44 .

4.Services contract: 20136101-SHAPING EUROPEAN EARLY DIALOGUES (SEED) report

Background information

The EU has supported cooperation in the field of health technology assessment (HTA) for more than 10 years, notably through the EUnetHTA joint actions 45 . Since November 2013, the HTA network, set up according to Article 15 of the cross-border healthcare Directive (2011/24/EU) provides strategic guidance on voluntary HTA cooperation in Europe.

In this framework, Chafea launched a call for tenders to carry out ‘early dialogues’ between the pharmaceutical industry and national HTA bodies that aimed to reduce uncertainty about the needs for data generation during the development phase of new health products (pharmaceuticals and medical devices).

Brief description

Under the service contract, the SEED Consortium delivered:

·methodological protocols and codes of conduct for early dialogues between multiple HTA bodies;

·11 early dialogues (7 on drugs and 3 on medical devices); and

·recommendations for a permanent model for conducting early dialogues.

To be a candidate for an early dialogue, companies had to submit a letter of intent 4 months before the anticipated date of the start of the procedure.

Additional templates for the submission file were developed for medicinal products and medical devices, including the list of questions called ‘briefing books’ and the ‘key issues’ to be identified by SEED partners, focusing on the controversial questions on the specific medical technology.

Specific results

·Early dialogues for medicinal products: on the nature of the products, 1 was an advanced therapeutic medicinal product, 6 were biotherapies, 1 was a small molecule, 3 out of 8 had an indication in oncology, and 3 were for treating rare diseases. The products were submitted in the context of discussions on the design of the Phase III trials.

·Early dialogues for medical devices: not all requests received met the eligibility criteria, reflecting the lack of experience of the medical devices industry on this type of exercise. The three chosen products were: (i) 1 implantable medical device developed by a well-established company; (ii) 1 diagnostic test developed by a smaller company; and (iii) 1 medical device to improve the penetration of active products being inserted in parts of the body, developed by a start-up with no experience in clinical development.

The project also provided a series of recommendation on how to strengthen the process of multi-HTA early dialogues on issues such as conflicts of interest, involvement of patients, role of regulators and sustainable funding models.

The SEED report is available on the Haute Autorité de Santé — HAS website 46 .

5.Services contract: 20147307 — Off-label use of medicinal products in the European Union Study report

Background information

EU legislation on the marketing authorisation of medicinal products aims to safeguard public health and to protect the free movement of these products. As part of this authorisation, the terms under which a product can be used safely and effectively are described in the product information. However, medicinal products might be prescribed and used outside these terms. This is what is called ‘off-label use’.

Off-label use refers to any intentional use of an authorised product not covered by the terms of its marketing authorisation. This may for example be the use for a different indication, use of a different dosage, dosing frequency or duration of use, use of a different method of administration, or use by a different patient group (e.g. children instead of adults).

Brief description

The report’s main aim was to describe existing and planned off-label practices across Member States. Its specific objectives were:

·to provide information on the prevalence and incidence of off-label use, and on its drivers;

·to provide information on the national frameworks (regulatory and other) governing the off-label use of medicinal products in various EU countries; and

·to provide a factual analysis taking into account the EU legal framework for off-label use and practices in the EU countries.

Applying a wide range of methods, including a systematic review of scientific literature and grey literature (i.e. reports and working papers), a legal analysis, interviews with stakeholders and an expert meeting, this study provided information on a variety of aspects of off-label use. These include the prevalence and incidence of off-label use and its drivers, as well as a description of the national frameworks (regulatory and other) governing the off-label use of medicinal products in the various EU countries.

A factual analysis was also prepared on how authorities have addressed the issue of off-label use and the different ways patients, healthcare professionals and industry react to this.

Specific results

The reports investigated the balance between the benefits and risks of off-label use for patients, and the regulatory framework for off-label use.

On the benefits side, off-label use helps to increase patients’ access to (innovative) treatments and to fulfil their medical needs, especially when no other option is available. It also contributes to the sustainability of the healthcare system.

Disadvantages include friction between national authorities and the pharmaceutical industry, and important liability issues.

The report also provided different policy options for professionals, industry, regulators and healthcare systems, among others. These included treatment guidelines, how to apply for permission to prescribe, appropriate reimbursement options, and incentives for pharmaceutical companies to register new indications.

The study is available on DG SANTE’s website 47 .

HIGHLIGHTS OF CO-FUNDED ‘CROSS-CUTTING’ AND ‘OTHER’ ACTIONS

1.Dissemination activities carried out in 2017

The dissemination strategy for the third health programme was adopted in June 2017. Its key principle was to link up with with activities organised by DG SANTE, international and European organisations, and EU countries in order to promote the health programme and disseminate its results at general and thematic events. For events organised by the Member States, a close cooperation with the health programme’s national focal points was essential.

In 2017, several dissemination activities were organised on key communication priorities indicated by DG SANTE, namely refugees’ and migrants’ health, European Reference Networks for rare diseases, the fight against antimicrobial resistance, HTA, crisis preparedness in health and chronic diseases.

In total 20 dissemination activities were carried out, attended by more than 3 000 participants. These included 2 conferences, 11 workshops and exhibition stands at high-level conferences during the Maltese and Estonian EU Council Presidencies, and two cluster meetings open to journalists.

Other dissemination actions included:

·the revamping of the online health programme project database 48 to enable stakeholders to access projects’ deliverables quickly and easily;

·the production of a set of 16 third health programme visuals depicting the health topics and usable on any communication tool; and

·the production of online tutorials and videos 49 on six topics to help potential applicants and beneficiaries to better prepare and manage their projects.

In addition, Chafea continued to raise awareness on health programme funding opportunities and on the programme’s results at national, EU-wide and international events.

·To encourage participation in the health programme by raising awareness on priorities and funding opportunities, Chafea organised 2 health programme webinars on 30-31 March 2017 50 , 10 national info days 2017 51 , and an info day on 2017 joint actions on 7 June 2017 with 135 participants.

·To facilitate knowledge sharing and disseminate results, Chafea was present at more than 20 national and EU-level events.

·Chafea’s health unit launched the first request for service under DG AGRI’s framework contract (lot 2) to organise a series of events, including in particular:

o21-22 March 2017, Madrid, Spain — Workshop and stand on the ‘rare disease registries’ — hosted by CIBER de Enfermedades Raras (CIBERER), the Spanish network of experts on rare diseases, alongside their annual meeting. Participants: 160.

o15 June 2017, Madrid, Spain — Conference ‘Preparedness, Alert and Response: Lessons Learned in Europe from Last Cross-Border Health Infectious Threats’, organised by DG SANTE and ECDC together with the Spanish Ministry of Health and the members of the Health Security Committee. Participants: 125.

o08-10 May 2017, Dublin, Ireland — Workshop and stand during the 17th International integrated care conference ‘Building a platform for integrated care: delivering change that matters’. Participants: 211.

o8-10 June 2017, Lisbon, Portugal — Conference ‘Healthy work environment, active health promotion and disease prevention at workplace’ organised by the Portuguese Health Directorate together with DG SANTE, DG EMPL, the Occupational Safety and Health Agency and the EU network of workplace health promotion. Participants: 123.

o1-4 November 2017, 10th European Public Health conference 2017, Stockholm (SE) —two workshops organised by Chafea in collaboration with DG SANTE, the European Observatory on Health Systems and Policies, European Implementation Collaborative, the Centre for Implementation Science, CLAHRC South London and King’s College London and the EUPHA Section on Public Health Policy and Practice. The two workshops focused on: ‘Sharing health information and evidence with policy makers: tools for transferring knowledge into policy action’ and ‘Implementation of innovations in public health policy and practice’. Participants: more than 100.

2.Other Actions

Collaboration with DG GROW in the field of medical devices development and maintenance, in support to the new Regulations on medical devices and in-vitro diagnostic medical devices by the legislators.

·Communication campaign

This communication and information campaign aimed to inform stakeholders about the legislative changes introduced by the new Regulations on medical devices 52 and in-vitro diagnostic medical devices 53 . The campaign targeted all stakeholders — particularly manufacturers — to ensure that they were aware of the requirements and timelines of the new Regulations. It therefore also aimed to avoid any disruptions to the medical devices market following the legislative modifications.

Tools included a new online hub dedicated to the new regulations on DG GROW’s 54 website. This hub provides information to the main stakeholders affected by the legislative change, namely: (i) manufacturers of medical devices and in-vitro diagnostic medical devices; (ii) authorised representatives, importers and distributers; (iii) health institutions reprocessing single-use medical devices; (iv) manufacturers of devices without an intended medical purpose; (v) healthcare professionals; (vi) health institutions; and (vii) institutions in charge of the procurement of medical devices and in-vitro diagnostic medical devices. The hub also targets authorities in non-EU/EEA countries that make use of the EU approvals system.

The campaign produced six factsheets and translated them into EU languages as well as non-EU languages such as Chinese, Japanese and Arabic. The campaign also involved webinars targeted at stakeholders and other easy-to-understand information material.

DG GROW liaised with competent national authorities to design and disseminate the campaign material at national level.

·European medical devices database (Eudamed)

A key way of meeting the objectives of the two new Regulations on medical devices and in-vitro diagnostic medical devices was to create a European database on medical devices (Eudamed) 55 .

The database integrates different electronic systems to collate and process information on devices on the market, including information on the manufacturers, certain aspects of conformity assessment, notified bodies, certificates, clinical investigations, vigilance and market surveillance. The database also aimed to increase transparency, for example by giving the public and health professionals better access to information. Other objectives included: (i) avoiding multiple reporting requirements; (ii) improving coordination between Member States; and (iii) streamlining and facilitating the flow of information between manufacturers, notified bodies or sponsors, and Member States — as well as among Member States, and between Member States and the Commission. As within the internal market this can only be ensured effectively at EU level, the Commission was tasked with further developing and managing the existing European databank on medical devices (Eudamed2) set up by Commission Decision 2010/227/EU 56 .

In 2017, the maintenance and support of the existing Eudamed2 continued, in parallel with the feasibility analysis for the creation of an entirely new and separate Eudamed, in line with the new Regulations’ requirements.

·Scientific and technical support from Joint Research Centre (JRC)

The Administrative Arrangement (AA) between DG GROW and the JRC ran from August 2015 to April 2017. It aimed to help set up scientific bodies — scientific panels for medical devices and European Reference Laboratories (EURLs) for in-vitro diagnostic medical devices — together with some elements on medical devices nomenclature. For the scientific panels JRC provided support on surveys — including the relevant implementing acts for their design and fees, and a call for experts. For EURLs, JRC provided implementing acts on tasks and compliance, developed principles for conflict of interest, and organised a call for applications by laboratories. Finally, on nomenclature JRC provided support at international (IMDRF) and EU level.

·Joint assessments of notified bodies

The action covers the expenses of national experts who participate in the joint assessments of notified bodies together with the Commission’s services in line with Article 3 of Commission Implementing Regulation (EU) No 920/2013 and Articles 38-42 and 123(3)(a) of Regulation 2017/745 on medical devices and Articles 34-38 and 113(3)(b) of Regulation 2017/746 on in-vitro diagnostic medical devices.

·Meetings of Medical Device Coordination Group (MDCG)

The funding covers the organisation and reimbursement of expenses for the meetings of the MDCG and its subgroups. The group’s tasks are laid down in the Regulations on medical devices and in-vitro diagnostic medical devices.

The budget for all activities under Priority 3.6 related to the new medical devices Regulations was EUR 4 637 189,27, broken down as follows:

oEUR 520 000,00 for the information and communication campaign; 

oEUR 2 218 000,00 for the development of the future Eudamed following the adoption of new medical devices Regulations; 

oEUR 1 350 000,00 for the AA with JRC; and 

oEUR 549 189,27 in support to the MDCG for meetings on the new Regulations.     

Development and maintenance of the European Health Care Quality on cancer (JRC)

Background information

The European Commission’s science and knowledge service, the Joint Research Centre (JRC), supports EU policies with independent scientific evidence throughout the whole policy cycle. The JRC’s work on health care quality on cancer involves the coordination and operational management of the European Commission’s initiative on breast cancer (ECIBC) 57 , which aims to ensure the quality of breast cancer services across European countries.

An important part of the ECIBC is quality assurance for breast cancer services. For this, the JRC coordinates the Quality Assurance Scheme Development Group (QASDG), which has developed a European QA scheme, applicable to breast cancer services in the EU.

The QASDG has defined six main processes of breast cancer care that the European Breast QA scheme should cover: (i) screening; (ii) diagnosis; (iii) treatment; (iv) rehabilitation; (v) follow-up and survivorship care; and (vi) palliative care; and four quality areas: (i) clinical effectiveness; (ii) safety; (iii) personal empowerment and experience; and (iv) facilities, resources and workforce.

Brief description

The ECIBC included a Guidelines’ platform — a publicly accessible collection of evidence-based guidelines for breast cancer. The platform covers selected topics of the patient care pathway and therefore complements the ECIBC screening and diagnosis recommendations. It also includes a collection of trustworthy evidence-based guidelines for breast cancer services.

Specific results

The ECIBC web hub is a ‘one-stop shop’ for breast cancer patients, professionals and policy makers. Is is a user-friendly platform for health stakeholders and the public to exchange messages. It should become a key resource for stakeholders, especially women looking for information on where to go and how to receive care compliant with the most up-to-date European standards.

The Guidelines platform hosts existing high-quality guidelines, developed by expert bodies outside the European Commission. The platform covers all breast cancer care processes after diagnosis 58  (treatment, rehabilitation, survivorship, palliative care).

The JRC has also developed a targeted European training template for digital breast cancer screening (the ECIBC training template). The training template aims to decrease disparities in skills and services and, in turn, will eventually considerably improve the quality of care. The ECIBC training template’s minimum requirement is to define the essential training programmes healthcare professionals must follow in order to be able to perform screening services that comply with the European Breast Quality Assurance Scheme. It focuses on the skills a professional must possess to be able to adequately perform the assigned tasks. The skill-focused structure of the template will allow its application in different countries, by different professionals and within a diverse array of legal frameworks.

The budget for all activities under Priorities 1.4 and 1.5.4. was EUR 2 300 000,00, broken down as follows:

oEUR 2 200 000,00 for: (i) the development and maintenance of the healthcare, quality, health data information (HQHDI) for rare diseases registries and the cancer registry; (ii) the update of the EU guideline on breast and colorectal cancer screening, including the European quality assurance scheme; and (iii) data compilation for chronic diseases, particularly on nutrition and physical activity, and related publications, including summaries of scientific studies

oEUR 100 000,00 for laboratory support for the revised Tobacco Products Directive’s (2014/40/EU) requirement on the submission of extensive data by industry (see Articles 5 and 6 (tobacco) and 20 (e-cigarettes)). 

IMPLEMENTATION OF ANNUAL WORK PROGRAMME 2017

CALLS FOR PROPOSALS

Calls for proposals, including one for projects, and an invitation to apply for the European Reference Networks specific grants and operating grants for civil society organisation (SGA), were all launched in March 2017 59  on the Horizon 2020 programme’s Participant Portal, on the Europa public health website 60 and on Chafea’s website 61 .

For the call for proposals for projects (supporting Member States in mainstreaming health promotion and disease prevention in health and educational settings), 11 proposals were submitted, but as none of them reached the quality threshold, no projects were funded.

All applications for ERNs specific grants for 2017 and 94% of FPA/SGA applications for operating grants were submitted by organisations in EU-15 62 Member States, the only exception being an SGA signed with an EU umbrella organisation from Cyprus.

Of the 6 joint actions signed, 5 (83%) proposals were from organisations in EU-15 Member States, and the remaining joint action (iPAAC) was coordinated by Slovenia. Of the 217 joint action beneficiaries, 51% were represented by organisation from EU-15 countries, 33% by organisations from countries that joined the EU after 2004 63 , 14% by non-EU countries participating in the health programme (Bosnia Herzegovina (BH), Republic Serbia (RS) and Moldova), and 2% by EEA 64 countries (Norway).

Chafea organised a workshop for joint actions on 7 June 2017 and a joint action quality assurance workshop on 18-20 October 2017. The health programme’s national focal points 65 also organised nine national information days (hosted in IT, PL, SE, IR, EL, RS, SK, LT, and BH) between March and June 2017. Guidelines for applicants were made available on the Participant Portal. The Chafea helpdesk also provided assistance and practical help.

Altogether, 23 proposals for ERNs and 16 operating grant proposals were received with a total proposed budget of EUR 10 316 224,31. However the total available budget for that year for the call for proposals — including for projects — and for ERNs and SGAs, was EUR 9 850 000,00.

Applications were evaluated in accordance with the rules and criteria set out in 2017 AWP 66  and the specific calls for proposals. There was also an external evaluation of the call for proposals to ensure an efficient and transparent selection of AWP 2017 proposals.

The proposals submitted under the various calls were evaluated by external experts (peer-reviewers). Nine external experts from 7 countries (AT, BE, EL, ES, IT, RO and SE) evaluated the FPA/SGA and ERN proposals, and 12 experts from 9 countries (DE, EL, ES, IT, LT, MT, NL, RO and NO) ensured the quality assurance of the 2017 joint actions. The experts were drawn from the list that was established following the call for expressions of interest in the area of public health — the EMI H2020 database 67 .

The evaluation process took place in two stages:

In the first stage, three external evaluators reviewed each proposal, and then a consolidated evaluation report for each proposal was drawn up at a consensus meeting organised by Chafea.

In the second stage, the evaluation committee checked that the evaluators had complied with the relevant rules and criteria. It then drew up final lists of proposals recommended for funding, together with reserve lists. The evaluation committee comprised representatives from the Directorate-General for Health and Food Safety (DG SANTE), the Directorate-General for Research and Innovation (DG RTD), and Chafea. The award decisions for 16 operating grants were taken by Chafea. Under the third health programme, there is no award decision for projects and ERNs, as it is signed together with the grant.

Project grants

Project grants were awarded to actions involving several partners, usually public health bodies and NGOs. The maximum EU contribution is 60% of eligible costs. However, the EU contribution may go up to 80% if a proposal meets the criteria for exceptional utility. In total, 11 proposals were submitted to the call for proposals for projects. Ten proposals were evaluated and 1 was rejected. No single proposal reached the threshold values. Therefore, no projects were funded in 2017 and the budget was re-allocated to other financial mechanisms.

European Reference Networks (mono-beneficiary grants)

ERNs, together with their proposals to become an approved ERN, which was conditional on their assessment by the Independent Assessment Bodies and ensuing decision of the Board of Member States, had also submitted an FPA proposal, together with their SGA proposals for their first year of operation.

Once the decision of the Board of Member States was taken and the 23 ERNs approved, Chafea invited them to the grant agreement preparation phase, with a view to sign the related FPAs and SGAs as quickly as possible in the year N+1.

According to the financing decision, each ERN could receive up to EUR 200 000,00. However, not all ERNs requested the full available amount. The co-funding awarded to them is in the table below.

Operating grants

Operating grants may be awarded to non-governmental bodies that pursue one or more of the health programme’s specific objectives. Operating grants were awarded to non-profit organisations that are:

·non-governmental;

·non-profit-making and independent of industry, commercial and business or other conflicting interests;

·working in the public health area;

·playing an effective role in civil dialogue processes at EU level;

·pursuing at least one of the programme’s specific objectives;

·active at EU level and in at least half of the Member States; and

·balanced in terms of EU geographical coverage.

All activities included in Annex 1 of the Regulation establishing the third health programme can be funded by a specific grant awarded under a framework partnership agreement (FPA).

FPA recipients are eligible for a specific grant agreement (SGA) (operating grant). These FPA recipients were invited to submit an application for an SGA to cover their operating costs for 2018. The maximum EU contribution is 60% of their annual operating costs. However, the EU contribution may increase to 80% if a proposal meets the criteria for exceptional utility. In 2017, from the 16 operating grants signed, 6 (38%) 68 qualified for exceptional utility.

In 2017, a call for proposals was organised for the signature of four-year FPAs for 2018-2021, in particular, but not limited to, the following priority areas: prevention and health determinants; chronic diseases; cancer; dementia; rare diseases; HIV/AIDS, tuberculosis, hepatitis; access to healthcare; and substances of human origin.

Out of the 17 applicants granted an FPA, only 16 received an SGA. This is because one applicant organisation — EuroHealthNet — had to withdraw their proposal because they received a grant from DG EMPL covering their costs for 2018. EuroHealthNet’s proposal was therefore removed from the ranking list.

By the end of 2017, the grant preparation process had been completed representing a budget of EUR 5 811 912,40

The following table lists all operating grants funded by objective and priority.

JOINT ACTIONS

The grants for actions co-financed with Member State authorities are, according to Article.7 2(a) of the third health programme 2014-2020 Regulation, ‘actions having a clear Union added value co-financed by the competent authorities of Member States responsible for Health or by public sector bodies and non-governmental organisations, acting individually or as a network, mandated by these competent authorities.’

They therefore allow the nominated national authorities of the Member State/other countries participating in the programme and the European Commission to work together on jointly identified issues.

Grants for joint actions were awarded to competent authorities or public sector bodies and non-governmental bodies mandated by those competent authorities.

The maximum EU contribution is 60%. However, the EU contribution may go up to 80% if a proposal meets the criteria for exceptional utility. Four (67%) out of the 6 joint actions 2017 qualified for exceptional utility 69 .

The procedure for joint actions changed under the third health programme to increase transparency and inclusiveness. Member States and other countries participating in the third health programme now nominate the competent authorities or other bodies as a first step. As a second step, their nominees are invited to submit a proposal under the direct grant procedure.

Six joint actions were co-funded for a total budget of EUR 20 229 410,14, covering the following objectives:

·health promotion (2 joint actions);

·health threats (2 joint actions); and

·health systems ( 2 joint actions).

There were no joint actions for the ‘better and safer healthcare’ objective.

Each of the six joint actions involved between 20 and 49 beneficiaries from EU/EEA countries and other countries participating in the programme.

The table below lists all the joint actions funded per objective and priority.

DIRECT GRANT AGREEMENTS AND PRESIDENCY CONFERENCES

Direct grant agreements with international organisations were awarded to international organisations active in the area of public health. The direct grants also include service-level agreements. The maximum EU contribution is 60%.

All in all, 8 direct grant agreements were signed by Chafea for a total of EUR 9 300 000,00, as follows:

1)2 direct grants (EUR 2 200 000,00) signed with the WHO for: (i) the State of Health in the EU country knowledge; and (ii) support for the implementation of national action plans on antimicrobial resistance (AMR).

2)4 direct grants (EUR 2 800 000,00) signed with OECD for: (i) the EU health report ‘State of Health in the EU’; (ii) the development of patient-reported measures; (iii) challenges to access to medicines; and (iv) trends and policies affecting the international migration of doctors and nurses.

3) 1 direct grant (EUR 3 300 000,00) signed with the Council of Europe on European Pharmacopoeia (European Directorate for the Quality of Medicines and Healthcare (EDQM)) (CoE — EDQM).

4)1 direct grant (EUR 1 000 000,00) signed with the International Organisation for Migration (IOM) for the implementation of the Personal Health Record as a tool for integration of refugees in EU health systems (RE-HEALTH 2).

The table below lists all direct grant agreements that were funded per objective and priority.

Presidency conferences

The Presidency conferences financed under the 2017 AWP included one on tackling the harmful use of alcohol, under the Estonian Presidency 70 , and one on pharmaceutical products and one on healthy nutrition — both under the Bulgarian Presidency.

1.The conference ‘Cross-Border Aspects in Alcohol Policy — Tackling Harmful Use of Alcohol’ aimed to reduce alcohol-related harm in the EU by strengthening the Member States’ capacities to implement effective health policy and tackle cross-border issues. The conference was held together with a debate at the Informal Meeting of Health Ministers on 30 October 2017 in Tallinn. Both events fed into the Council conclusions on these issues.

2.Under the Bulgarian EU Council Presidency 71 two conferences were organised.

•The first on ‘Healthy Future for Europe: A Healthy Child Nutrition’  took place on 6 February 2018. Discussions and debates by EU and international experts focused on subjects such as healthy food and food for children, the link between nutrition and health, the impact of food on children’s development, healthy eating habits as a key health determinant, food marketing regulation practices for children, the role of traditional diets, and prospects for a ‘healthier’ future common agricultural policy responsive to the needs of affordable, healthy food.

•The conference on Options to provide better medicines for all European citizens took place on 6 March 2018. It aimed to provide a platform for discussion on key issues related to drug deficiency, legal possibilities and e-solutions to regulate parallel exports as well as securing effective medicines at affordable prices.

PROCUREMENTS (SERVICE CONTRACTS)

Procurement (service contracts) was used to purchase services. Contrary to the grants, the health programme covers the full cost of the procurement action. These services were implemented through service contracts based on existing framework contracts, services contracts or new framework contracts to cover needs as specified in the work plan for 2017. They include:

·evaluation, monitoring of actions and policies, including impact assessment;

·studies, data analysis and information on health;

·databases development and maintenance;

·organisation of workshops, training, expert panels and coordination groups;

·scientific and technical assistance, provision of advice and opinions;

·communication, translations and publications;

·awareness raising and dissemination of the results; and

·information technology applications in support of policies.

In 2017, DG SANTE signed several service contracts and specific requests using existing framework contracts (FWC). Most of these contracts and requests were for cross-cutting actions, such as communication and IT services for the maintenance and functioning of existing IT tools.

Procurement contracts also included contracts with experts working for the scientific committees, and evaluation and monitoring studies. The overall public procurement budget implemented by DG SANTE under AWP 2017 was EUR 8 717 409,07.

The overall public procurement budget implemented by Chafea under AWP 2017 was EUR 5 863 073,68.

In 2017, CHAFEA managed 29 new market procedures for the acquisition of services (8 contracts under health promotion, 3 contracts under health threats, 3 contracts under health systems, 1 under better and safer health care) and 14 (48%) for measures to support the dissemination of health programme results.

The amounts per objective and authorising organisation were as follows:

The table below lists all service contracts signed per objective and per priority by Chafea and by DG SANTE.