EUROPEAN COMMISSION

Brussels, 12.12.2018

SWD(2018) 489 final

COMMISSION STAFF WORKING DOCUMENT

Accompanying the document

Report from the Commission to the European Parliament and the Council

Implementation of the third Programme of Community action in the field of health in 2015

{COM(2018) 818 final}

TABLE OF CONTENTS

INTRODUCTION    

JOINT ACTIONS    

ORPHANET    

PROJECTS    

1.    EUReMS – European Register for Multiple Sclerosis – A tool to assess, compare and enhance the status of people with Multiple Sclerosis throughout the EU    

2.    EPIRARE – European Platform for Rare Disease Registries    

3.    EURO-WABB – EU Rare Diseases Registry for Wolfram syndrome, Alström syndrome, Bardet-Biedl syndrome and other rare diabetes syndromes    

4.    EUREGENAS – European Regions enforcing Actions against Suicide    

5.    SIALON II – Capacity building in combining targeted prevention with meaningful HIV surveillance among MSM    

6.    Special Call: Support Member States to migratory pressure in their response to health related challenges    

7.    8 NGOs in 11 States    

8.    SH-CAPAC – Supporting health coordination, assessments, planning, access to health care and capacity building in Member States    

9.    EUR-HUMAN – European Refugees – Human Movement and Advisory Network    

10.    CARE - Common Action for Refugees and other migrants’ health    

OPERATING GRANTS    

1.    EURORDIS FY2015 -2018 European Organisation for Rare Diseases    

DIRECT GRANTS WITH INTERNATIONAL ORGANISATIONS    

1.    OECD-PS – DATA AND ANALYSIS OF DATA ON PATIENT SAFETY WITHIN THE OECD HEALTH CARE QUALITY INDICATORS PROJECT    

2.    OECD-HWF – Feasibility study for an international survey of health workers’ skills    

3.    OECD-EOP – Economics of Prevention    

4.    IOM - RE-HEALTH - Support Member States under particular migratory pressure in their response to health related challenges    

CALLS FOR TENDERS    

1.    SERVICE CONTRACT: Life Table Analysis: health system cost effectiveness assessments across Europe    

2.    SERVICE CONTRACT: The review and mapping of continuous professional development and lifelong learning for health professionals in the EU    

3.    SERVICE CONTRACT: Recruitment and Retention of the Health Workforce in Europe    

4.    SERVICE CONTRACT: EUREST - Study on the development of an EU common reporting format for submission of data on ingredients contained in tobacco and related products, and disclosure of the collected data to the public    

5.    SERVICE CONTRACT: Tobacco tracking & tracing    

6.    SERVICE CONTRACT: Economic landscapes of human tissues and cells for clinical application in the EU    

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

1.    Dissemination activities carried out in 2015    

2.    Other Actions    

Scientific Committees    

Expert Panel of Health    

Expert Panel on effective ways of investing in health    

IMPLEMENTATION OF ANNUAL WORK PROGRAMME 2015    

CALLS FOR PROPOSALS    

Project grants    

Operating grants    

Joint actions    

Direct grant agreements and Presidency Conferences    

Procurements (service contracts)    

Other actions    

DETAILED OVERVIEW OF THE REPORTING YEAR    

1.    Funding per thematic priority and financial instrument    

INTRODUCTION

This Commission staff working document accompanies the report on the implementation of the third Health Programme in 2015. The report highlights some of the key initiatives co-funded to further EU health policy and implement EU directives. This staff working document also showcases the results of measures co-funded under the second Health Programme, which ended in 2015: it provides a focus on actions that were co-funded in 2015 responding to the specific needs raised under the refugee crisis (CARE, EUR-HUMAN, SH-CAPAC, 8 NGOs in 11 States). It further includes actions that correspond to overarching themes (such as rare diseases and pilot European Reference Networks, tobacco control, health work force and patient safety, mental health, HIV/AIDS) which have been included in successive financing decisions. Lastly, it highlights several useful figures and statistics, rolls out the full list of all co-funded initiatives and contracts provided from the third Health Programme operating budget in 2015.

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

Several initiatives co-funded under the second Health Programme ended in 2015 and produced interesting results that were further taken up and built onto different levels of other actions. Several examples of actions that had significant outcomes are described below. More information about these and other projects and joint actions and their results can be found in the Health Programme Database managed by the Consumers, Health, Agriculture and Food Executive Agency (CHAFEA) 1 .

Please note that this Database covers actions co-funded under the EU Public Health Programme, namely the second and third Health Programmes.

Most importantly, the amended 2015 work programme called for the co-financing of actions related to "Support Member States to migratory pressure in their response to health related challenges" which covered Objective 1 and Objective 2 of the third Health Programme. As mentioned in the main report (REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL - Implementation of the third Programme of Community action in the field of health in 2015) four projects were awarded EU co-funding from the third Health Programme and one direct grant was signed with IOM.

JOINT ACTIONS

ORPHANET

Background information

ORPHANET is the world reference portal for information on rare diseases and orphan drugs, for all audiences, including patients, policy makers, healthcare professionals and the scientific community at large. It is coordinated by the French INSERM institute and brings together partners from 23 Member states (AT, BE, BG, CY, CZ, EE, FI, DE, GR, HU, IT, LT, LV, NL, PL, PT, RO, SK, SL, ES, SE, UK). From 2011 to 2015, the action received EU co-funding of EUR 3 500 000.

Brief description

ORPHANET’s objective was (and remains) to help improve the diagnosis, care and treatment of patients with rare diseases. The Orphanet database is a strategic element in national policies for Rare diseases: its nomenclature and classification are the basis for codification of these diseases in national health information systems.

ORPHANET provides a single hub where all information and knowledge is collected, reviewed, validated and disseminated back to the national health systems and all other stakeholders and actors: to the health professionals to improve their understanding and knowledge of these diseases; to the researchers and academics, to develop new treatments and therapies, to the policy makers at local, regional, national and international levels to develop appropriate responses; and, more importantly, to the patients themselves.

In its current development phase, the network developed tools for improving the validation and publication of data collected by national teams. The action also focused on upgrading the quality of the database, easing its update and validation.

Specific results

Information delivered through the Orphanet website, is accessed more than 35,000 times/day from more than 200 countries, representing 1.3M sessions a month. Massive datasets are made available for free re-use by researchers, industry and policy-makers in machine-readable formats through Orphadata (approximately 14,000 downloads/month).

The Orphanet website is currently available in 8 languages (English, French, Italian, Spanish, Portuguese, German, Dutch and Polish), but the textual information is progressively translated in many more languages.

Orphanews has a multi-stakeholder audience (2017 data) of 12’000 subscribers for the English language version alone (more than 8’400 subscribers for the French edition and 5’600 for the Italian edition)

Orphanet provides access to a catalogue of expert services by disease in 35 countries of the 41-countries Orphanet network, such as centres of expertise, laboratories and diagnostic tests, patient organisations, research projects and clinical trials, registries, biobanks and research infrastructures.

The Orphanet encyclopaedia is intended to help professionals in their clinical practice, but patients and their relatives also benefit from it.

Orphanet disseminates good quality articles produced by other stakeholders, including articles intended to lay persons, after having assessed them for quality. The high-quality directory of expert resources and patient organizations is of help both for health professionals and for patients, improving referrals and patient orientation.

PROJECTS

1.EUReMS – European Register for Multiple Sclerosis – A tool to assess, compare and enhance the status of people with Multiple Sclerosis throughout the EU 

Background information

As one of the projects of the health promotion strand, the European Register for Multiple Sclerosis (EUReMS) project ran from July 2011 until September 2014 with a co-funding of EUR 987.198,00. It involved a consortium of 12 partners from ten EU countries (BE, DE, ES, HR, IT, NO, PL, RO, SE, UK) to address the unmet needs of people living with Multiple Sclerosis (MS). Further to its geographical outreach, the action also brought together partners from different sectors such as professional societies and patient organisations, public health organisations, research and academic organisations, ensuring that their unique perspectives contribute directly to the actions' results.

Brief description

The project addressed the lack of comparative data at EU and national level on treatment and care for people with multiple sclerosis and was, thus, closely aligned with the European Commission’s efforts to fight health inequalities faced by European citizens.

As a pioneer in this field, EUReMS identified and pooled MS-related data from different registries – hospitals, professional societies and research centres around Europe – and created a cross-border partnership for its safe and effective storage, analysis, interpretation and dissemination. It also proved that integration of data from different sources is possible: the establishment of a European Platform for systematic collection, exchange and analysis of longitudinal data on MS in Europe will eventually lead to a better assessment of the situation of people with MS and ultimately to better outcomes for those living with MS in Europe.

Specific results

The information gathered through EUReMS is being stored at/ managed by the Medical Centre of the University Göttingen, Germany, while dissemination is coordinated by the EMSP through its Secretariat in Brussels.

EUReMS data already enabled the analysis of: costs and resources related to the burden of disease; age and gender-specific disease trends; and use of disease-modifying drugs and their impact.

This newly created data pool also proved that more and better data can drive policy improvements and provide incentives for new research, by opening up post-project end studies on: prevalence and incidence of MS in Europe; access and effectiveness of treatments; quality of life and burden of disease issues.

2.EPIRARE – European Platform for Rare Disease Registries

Background information

The project ran from April 2010 to October 2013 with an EU contribution of EUR 661 402. Under the leadership of the National Centre for Rare Diseases of the Italian Istituto Superiore di Sanitá (ISS) it involved partners from 8 countries (BE, BG, ES, FR, GR, IT, NL, UK).

The project aimed to build wide ranging consensus among the scientific community and policy makers to address regulatory, ethical and technical issues associated with the registration of rare diseases patients and to elaborate possible policy scenarios. In fine, the action studied the feasibility of registration of a minimum data set common to all rare diseases, designed to inform policy-making; the conditions to admit research-driven disease or treatment-specific modules; and the ways to ensure a sustainable data flow. Specific attention was given to the scenario of the creation of an EU platform for the collection of data on Rare diseases patients and their communication among qualified users.

Brief description

The project identified possible policy scenarios to enhance data collection in the area of rare diseases, defining the scope of such collection; the corresponding governance framework and possible options for sustainability, including an enabling legal framework. To do so, it identified all the existing registries, whether pharma centred or oriented towards wider public health aims; industry sponsored, academic, or publicly owned.

The sustainability of EU Rare disease patients' registration was pursued by defining the aims and the scope of a potential common EU wide platform and appropriate governance models. Finally, a common data set was developed, consistent with a public health approach, while attention was also given to the use of different data sets and the services which could potentially be made available based on the latter. The involvement of all relevant stakeholders was also ensured, considered instrumental to foster the implementation and sustainability of the recommendations made at the end of the action.

Specific results

The project prepared the ground for the collection of an agreed common set of data from rare diseases patients providing also rules to ensure data quality and data validation and improve as far as possible comparability of data among countries.

The results of the action were taken up by the EU Committee of Experts on Rare Diseases (EUCERD) and have been instrumental in the collaboration agreement established between DG SANTE and the Joint Research Centre (JRC), tasked with carrying forward the efforts for an EU-wide RD registration effort. The results of the action are available on the project website 2 as well as in CHAFEA's Health programme Database 3 .

3.EURO-WABB – EU Rare Diseases Registry for Wolfram syndrome, Alström syndrome, Bardet-Biedl syndrome and other rare diabetes syndromes 

Background information

The project ran from January 2011 to June 2014 with an EU contribution of EUR 900 000. It involved partners from 6 countries (EE, ES, FR, IT, PL, UK) and supported efficient diagnosis, treatment, and research for the overlapping rare genetic diseases Wolfram, Alström and Bardet Biedl syndromes and other rarer diabetes syndromes in Europe. This was achieved by implementing an EU registry for Rare Diabetes Syndromes, containing clinical, genetic diagnostic and outcome data.

Brief description

The purpose of the registry was: 1) to establish the natural history of Rare Diabetes Syndromes (their characteristics, management and outcomes); 2) to assess clinical effectiveness of management and quality of care; 3) to provide an inventory of patients for recruitment to intervention studies; and last but not least 4) to establish genotype-phenotype correlations.

The project used validated, quantitative questionnaires and focus groups of health professionals, to scope the requirements of centres for submitting data to the Registry. Further, it developed a consensus on a core dataset for the Registry, then developed a multifunctional web based Registry with user friendly browser-based access. To achieve high usage of the registry, this was linked to rapid genetic testing 4 ; and to up to date, accurate information, and education material.

Specific results

The project led to a step change in the volume and quality of clinical research in Rare Diabetes Syndromes diseases by enabling the following important outcomes: equal access to genetic testing, education of health professionals, and empowerment of patients (Council Recommendation on rare diseases); adequate inventorying of Rare Diabetes Syndromes diseases; supporting research; development of centres of expertise; gathering expertise at European level; empowering patient organizations as partners; developing sustainability by underpinning a future European Reference Network for Rare Diabetes Syndromes diseases; supporting the High Level Pharmaceutical Forum Recommendations (2008); and supporting improvement in health outcomes which is a key Lisbon strategy indicator.

The registry is also transferable to scientists exploring the mechanisms underlying common diabetes and obesity. This will enable a change the understanding of these rare diseases through increased knowledge of the natural history and genotype phenotype relations informing prognosis. Rare Diabetes Syndromes diseases will have increased visibility to the research and health provider communities through Orphanet 5 and EURORDIS. A change in clinical effectiveness of services for Rare Diabetes Syndromes patients can also be expected: the registry will provide data for assessing the clinical effectiveness and cost-effectiveness of standard care and new interventions in a real-world setting. This, in turn, would lead to improvements in quality of care. The Registry is expected to identify disparities between health care outcomes and provide evidence for health service providers for improvements.

The results are available on the project website 6 as well as in CHAFEA's Health Programme Database 7 .

4.EUREGENAS – European Regions enforcing Actions against Suicide

Background information

A health promotion action, the EUREGENAS project ran from January 2012 to December 2014 with a co-funding of EUR 750 000. It involved 19 partners in 10 EU countries (BE, DE, ES, FI, IT, PT, RO, SE, SI, and UK).

The EUREGENAS project contributed to the prevention of "suicidality" (suicidal ideation, suicide attempts and suicide) in Europe through the development and implementation of innovative strategies for suicide prevention at regional level that can be of use as examples of good practice across other regions of the European Union.

Brief description

The action has been implemented following the 5 following phases:

·Identifying and cataloguing good practices of existing actions and strategies on suicide prevention

·Carrying out a stakeholders’ needs analysis

·Developing and disseminating guidelines and toolkits on suicide prevention and awareness raising strategies

·Developing the technical specifications for an integrated model for e-mental healthcare oriented at suicide prevention

·Improving knowledge and capabilities among local and regional professionals (i.e. psychologists, psychiatrists, general practitioners)

Specific results

The action involved a range of professional categories, including key target groups outside the medical profession (e.g. journalists, teachers, stakeholders from the workplace), as evidence points to the role which they can play in effective prevention methods. With their help it delivered a series of innovative tools on several levels; they include a "Suicide prevention toolkit for Media Professionals, Workplace and Schools"; a "Training module for General Practitioners"; and a "Toolbox for facilitators of survivor support groups".

Acknowledging the potential of Information and Communication Technologies in reaching the younger population, especially vulnerable to the "idealisation" of suicide, the action also developed tools addressing both the ethical and technical dimensions of Information and Communication Technologies enabled prevention (eg: Ethical Guidelines for Technology-Based Suicide Prevention Programmes).

The deliverables of the action are highly innovative and have attracted significant interest from several other EU regions; and they are accessible in the project's online library ( http://www.euregenas.eu/publications/ ).

For further information, visit CHAFEA's Health Programme Database 8 .

5.SIALON II – Capacity building in combining targeted prevention with meaningful HIV surveillance among MSM

Background information

The health security project SIALON II project ran from November 2011 to January 2015 with a co-funding of EUR 989 960, 00. It brought together 28 partners representing Public Health Institutions, Academia and NGOs from 10 European countries (BE, BG, ES, DE, IT, LT, PL, PT, RO, SK) with the overall objective to carry out and promote combined and targeted prevention complemented by a meaningful surveillance among men who have sex with men .

Brief description

HIV/AIDS is recognised as a major cross border health threat. Recent data painting an alarming picture of increased prevalence, especially in the context of the financial crisis and the reduction of national prevention budgets to which it has resulted in. The HIV/AIDS surveillance 2014 report by the European Centre for Disease Control (ECDC), shows that the number of HIV diagnoses among men who have sex with mencontinues to increase in the EU/EEA, representing the higher proportion (42%) of new HIV diagnoses

To better understand the underlying causes of this situation, Sialon II worked on generating comparable data on behavioural and epidemiological indicators for men who have sex with men communities in 13 different EU Member states.

The action applied new methods building an extensive prevention and promotion campaign, and resulting in extensive voluntary community testing. The contribution of the primary target group enabled the use of high impact methodologies, such as oral fluid and serum testing methods for HIV/STI surveillance. It also resulted in the expansion and consolidation of a very extensive European network used for the statistical analysis and data comparison based on a commonly developed framework.

Specific results

The project became an international reference initiative, presented by UNAIDS, WHO and ECDC as a model for bio-behavioural surveillance and prevention among men who have sex with men.

The SIALON II results showcased the importance of the active involvement of stakeholders: the men who have sex with men civil society organisations were directly implicated on the survey design; the performance of the data collection; the review of the survey report, including the creation of city profiles; and the execution of prevention activities, based on community involvement and peer to peer education.

Further to the quantitative data on HIV prevalence in general - and new infections in particular - the survey main findings were summarised in a policy brief - City Profile - focusing on the main prevention implications at local level.

Further information is available on the Sialon II website 9 .

6.Special Call: Support Member States to migratory pressure in their response to health related challenges

In urgent response to the Call to "Support Member States to migratory pressure in their response to health related challenges", and as mentioned in the main report, the highlight of 2015 was the amended annual work programme 2015 that added another Call. In turn, four projects were awarded EU co-funding from the third Health Programme and one direct grant was signed with the International Organisation for Migration (IOM). The actions' aims were to support Member States under particular migratory pressure in their response to health related challenges and were implemented throughout 2016 as an immediate response: 8 NGOs in 11 States, SH-CAPAC, EUR-HUMAN, and CARE; and one direct grant with IOM described below under the section on Direct Grants with International Organisations.

7.8 NGOs in 11 States

Background information

The Project 8 NGOs in 11 States is a project where 8 NGOs came together to support the health authorities of 11 EU Member States (BE, BG, DE, EL, ES, FR, HR, IT, NO, SE, SI). Led by Médecins du Monde 10 , it supported the health authorities of the participating Member States in providing individual health assessments via the use of an agreed EU health booklet (used also by DG HOME) that could identify specific health issues and prevent health threats.

Brief description

The project focused on implementing flexible and adaptive mechanisms such as mobile surveillance and response health units to identify arrival and transit locations to provide continued assessment and meeting of geographically rapidly changing needs. Further, it assessed general health needs and emerging needs and responded to urgent health issues.

The 8 NGOs thus ensured the reduction of cross-border health threats, carried out health assessments of individuals (for mental and physical health), referred to adequate and accessible primary healthcare (including vaccination), informed on migrants' rights to access healthcare. The 8 NGOs also improved appropriate response and inform health authorities by sharing and discussing experiences and lessons learned with local and national health authorities and with European policy makers; ensured that monitoring of health needs and access to health for migrants were monitored and core indicator data collection. Last but not least, the 8 NGOs built within its team capacities in responding to urgent migrants’ health needs through active European coordination and mutual learning mechanisms.

Specific results

The action deployed 12 mobile units in 11 participating countries; 2012 contacts were carried out with other actors in order to map the needs; the mobile units accessed 699 detected spots within the identified areas of intervention; and a total of 2459 urgent individual health assessments were carried out with newly arrived migrants.

The 8 NGOS performed health assessments in 11 participating countries: 49 707 physical and 1 775 mental health assessments; and 4 811 social consultations were also carried out.

There were 2 459 urgent individual health assessments with newly arrived migrants, 3 270 referrals to public health care providers, 26 601 leaflets disseminated, 250 calls to the hotline, and 443 migrant group sessions (info/education). The 8 NGOs also involved in information and awareness initiatives and carried out 992 meetings with health authorities and other local actors where 494 health professionals participated in the sessions.

Publications and further information can be found on the website of Médecins du Monde 11 .

8.SH-CAPAC – Supporting health coordination, assessments, planning, access to health care and capacity building in Member States

Background information

Project SH-CAPAC – "Supporting health coordination, assessments, planning, access to health care and capacity building in Member States under particular migratory pressure", led by the Andalusian School of Public Health, brought together partners from 7 countries (BE, DK, ES, IT, NL,PL, SK). to support MS in the establishment or strengthening of a health sector coordination mechanism, improving capacities and skills of health professionals and ensuring adequate control of potential health threats for a coherent and consolidated national and cross-country response to the potential impact of the extraordinary influx of refugees, asylum seekers and other migrant populations.

Brief description

The action firstly mapped the response of the participating MS to the health needs of refugees, asylum seekers and other migrants. Country Profiles were prepared for each of the 19 target countries of the project with analyses of major trends: countries of first arrival and transit countries (BG, HR, EL, HU, IT, RO, SK, SI), traditional destination countries (AT, BE, DK, FR, DE, MT, SE, NL), new destination countries (PT, PL, ES). Further, SH-CAPAC supported:

·The development of action plans for implementing a public health response and for reinforcing their health systems

·The promotion and assurance of access of the refugee, asylum seekers and other migrants populations to health care and public health interventions through the development and dissemination of a resource package to reorient local strategies and plans

·The building of national capacity through training health workers

·The analysis of health challenges and unmet health needs

Specific results

The results were achieved through the development of practical materials, among others: the Coordination Framework; Guide for Assessment of Health Needs and Health Protection Resources; Guidelines for the Development of Action Plans for Implementing a Public Health Response and to strengthen Country’s Health Systems to address the needs posed by the influx of refugees, asylum seekers and other migrants.

Aimed at helping relevant stakeholders in target Member States to develop action plans and contingency plans to address the health needs posed by the influx of refugees, asylum seekers and other migrants. SH-CAPAC also engaged in 6 country support missions to BG, GR, ES, SK to introduce, disseminate and discuss the frameworks, methodologies and tools to further explore the possibilities for improving coordination and coherence in the response.

Publications and further information are available on the project's website 12 .

9.EUR-HUMAN – European Refugees – Human Movement and Advisory Network 

Background information

EUR-HUMAN was led by the University of Crete and involved 11 partners from 8 countries. The project enhanced the capacity of EU MS accepting migrants and refugees via establishment of guidelines, guidance training and health promotion material and establishing protocols and tools for assessment of local resources available. This initiative focused on addressing both the early arrival period and longer-term settlement of refugees in European host countries.

Brief description

The project focused on defining, designing and evaluating interventions aimed at developing integrated human-centred interventions for the provision of primary health care to refugees and other migrants.

Such interventions included, amongst others, the development of tools and guiding documents for the provision of continuous primary health care (including emotional, psychosocial and physical wellbeing assessments), from the arrival toward any relocation and final destinations.

In coordination with national, regional and local stakeholders engaged in providing assistance to migrants and their families, EUR-HUMAN targeted newly arrived refugees and migrants, primary health care professionals and social service providers across different settings.

Specific results

The project was grounded on a holistic and person-centred Model of Continuity of Care aimed at the provision of appropriate acute and PHC, as well as social service support to refugees and other migrants. Applying a Participatory Learning and Action research methodology, the health needs, social problems and barriers to access primary health care were identified for refugees and other migrants.

By developing an Appraisal Tool for Optimizing Migrant Health Care’ (ATOMiC), a practical guidance for improving quality and access to PHC services was specifically made then available for primary health care professionals, health managers and policy makers.

A Model of continuity of psychosocial refugee care was also developed to address mental health aspects related to migration. A Protocol for early identification of highly traumatized refugees and other migrants was developed based on a step wise model of care consisting of triage, screening, immediate assistance based on Psychological First Aid principles, and referral procedure for full mental health assessment and care as needed. It included guidelines and procedures for rapid assessment of mental health needs and psychosocial status. Models, protocols and tools produced by the project were finally piloted and tested against effectiveness in participating countries during an Intervention Training Programme made available also on-line (e-training). It consists of eight different modules for primary health care providers, translated in seven EU languages (plus Arabic) and adapted to country-specific settings (early hosting and first care centres, transit centres and centres for asylum seekers).

More results are available on the project website 13 as well as in CHAFEA's Health Programme Database 14 .

10.CARE - Common Action for Refugees and other migrants’ health 

Background information

CARE - Common Action for Refugees and other migrants’ health was led by the Italian National Institute for Health Migration and Poverty and included a broad and highly skilled mix of public health authorities and civil society organisations from five European Countries (GR, HR, IT, MT, SL), all with scientific, policy and public health background . The main focus of the CARE project was to promote and sustain the good health of migrants and populations in MS experiencing strong migrant pressure.

Brief description

The project focused on the collection of health data for syndromic surveillance in hotspot/reception centres and establish digital health records. Further, the project also monitored communicable diseases by ensuring rapid detection of disease outbreaks, while also assessing the current policy in vaccination, and provided information on endemic and current epidemic diseases in the countries of origin. Furthermore, the project tracked and monitored health status of migrants/refugees at the moment of their arrival based on advanced technology (smart devices and tags).

The CARE project also engaged in raising knowledge and awareness actions towards the general public with regard to “true” and “false” health topics about migrants and refugees and among others also promoted migrants health literacy with emphasis on the right to access public health care services in MSs aiming to facilitate delivery of services to migrants according to their age. Last but not least it supported national/regional planning and the role of civil society organisations to support the development of integrated public health plans, relevant to migrant and refugee populations.

Specific results

The project ensured the performance of over 11 000 medical examinations in IT. It also developed and tested of a Protocol for age assessment into the hotspots through a holistic approach with assessment of 75 children in IT and 103 in GR. Furthermore, it developed the following: syndrome surveillance system, web-based platform, survey on immunization policies targeting newly arrived migrants in different EU countries; travel medicine information service model on endemic and epidemic diseases in the migrants' countries of origin and transit using digital disease detection (13 dispatches produced); the customization and production of an electronic health record; created residential database (2 in IT; 4 in GR) and inventory of all the existing materials, practices and trainings in participating countries and many other very practical materials (for example, informative booklets and leaflets in different languages addressing health literacy for migrants and misconceptions about migrants for general population). In addition, the project helped identify good practices and prepared recommendations for public health policy regarding migrant and refugee populations and the role of civil society organisations (IT, GR and SI).

The results are available on the project website 15 as well as in CHAFEA's Health Programme Database 16 .

OPERATING GRANTS

2015 was the first year that CHAFEA has implemented the so-called Framework Partnership Agreements as a means of providing a new framework of long-term cooperation and financial support to Non-Governmental Organisations active in any of the areas of the Health programme.

Such an approach was considered as an adapted response to the needs of such organisations: this type of agreement helps establish a partnership structure for important actors of civil society at EU level; secondly, it offers a clearer financial perspective for the non-governmental bodies/ networks; and thirdly, it provides more stability and efficiency gains for all involved.

In total 14 framework partnership agreements were signed with successful applicant organisations covering the years 2015-2018, and resulting in financial support being awarded to through the linked specific grant agreements to cover their annual recurrent operational expenses for the financial years 2015-2018 17 .

Ten framework partnership agreements and their Specific grant agreements responded to the Objective 1 of the third Health Programme: "Promote health, prevent diseases and foster supportive environments for healthy lifestyles taking into account the 'health in all policies' principle", whereas another three, responded to Objective 4: "Facilitate access to better and safer healthcare for Union citizens".

Table 1: List of applicant organisations having been awarded an Framework partnership agreement and subsequent Specific grant agreement

1.EURORDIS FY2015 -2018 European Organisation for Rare Diseases

Background information

The operating grant in the field of rare diseases EURORDIS ran from 2015 through to 2017 with a maximum EU co-funding of EUR 2 354 422.

EURORDIS is a patient-driven alliance of Patient Organisations supporting the active involvement of Rare Disease patients, families and their representatives – as the main concerned segment of civil society - in the definition of priorities and implementation of actions on rare diseases at national, EU and international levels.

Brief description

A key objective of EURORDIS is to consolidate the Rare disease patient’s community and strengthen the patients’ voice.

Bringing together more than 700 patient organisations and speaking as a single voice for them creates a unique capacity to reach out, a capacity that no single patient organisation could attain on its own. In addition, a significant amount of resources go into capacity building activities, empowering Rare disease patients as advocates and volunteers.

Another of the main focus areas of EURORDIS is to improve access to high quality health and social care services for rare diseases patients, including diagnosis, treatment, or interventions improving quality of life. To do so, EURORDIS has actively represented patients in all initiatives relevant to these areas, including the active participation in the committees of the European Medicines Agency; the collaboration on HTA; the implementation of the EU pharmacovigilance legislation; or the setting up of European Reference Networks (ERNs).

It has thus established itself as a key actor and recognized and respected partner by the academic and research communities, governments and public health authorities, as well as EU institutions.

Specific results

The operating grant has enabled among other activities:

·The consolidation of the rare disease patient community with: an increase of the EURORDIS Membership base; the public awareness campaigns and the Rare Disease Day; the update and maintenance of the EURORDIS website; the dissemination of electronic newsletters; the management of EURORDIS social media; the production and dissemination of reference documents. EURORDIS continued to provide networking and capacity building opportunities to its members in 28 EU countries in 2017. RareConnect 18 , the EURORDIS online patient communities platform continued to grow reaching over 26 000 registered users & 90 communities. By the end of 2017 EURORDIS increased the number of the patient organisations in its contact database to 2 712.

·The engagement of rare patient representatives into the effective implementation and monitoring of legislation and strategies through support of patient involvement in Commission Expert Groups such as the EU Committee of Experts on Rare Diseases; the European Medicines Agency’s Committees and activities; promotion of access to medicines.

·The capacity building and empowerment of EURORDIS members and volunteers through: the annual EURORDIS membership meeting which includes capacity building workshops for members; provision of support to the Council of the European Network of National Alliances and the Council of European Federations; the EURORDIS Summer School in drug development, clinical trials, regulatory affairs which reached a significant number of attendance with 62 participants representing 27 countries and 43 diseases. The Operating grant has also enabled EURORDIS to identify, involve and support a growing volunteer base (from 132 in 2014 to 428 in 2017).

DIRECT GRANTS WITH INTERNATIONAL ORGANISATIONS

The AWP 2015 under Actions under Objective 1, Objective 3 and Objective 4 committed several direct grants with the OECD. This report highlights three such actions that are overarching across the second year of the third Health Programme.

In addition, IOM's RE-HEALTH direct grant is also presented below to illustrate the response to migratory pressure and responding to Objective 1 and Objective 2 of the third Health Programme. This direct grant complemented the 4 co-funded projects in this field of work as described above (under the section PROJECTS).

1.OECD-PS – DATA AND ANALYSIS OF DATA ON PATIENT SAFETY WITHIN THE OECD HEALTH CARE QUALITY INDICATORS PROJECT

Background information

This action, falling under Objective 4 of the EU Health Programme on "Facilitating access to better and safer healthcare for Union citizens" and more specifically under "Data and analysis of data on patient safety" and within the OECD Health Care Quality Indicators Project. OECD-PS received an EU co-funding of EUR 150.000,00.

The policy importance of the OECD’s indicator development work was noted in December 2014 by the Council of the European Union and subsequently by the European Parliament in making its resolution on safer healthcare in Europe in May 2015.

In the resolution, the Parliament welcomed the work co-financed by the EU and performed by the OECD on comparable patient safety indicators and called on EU Member States to implement such indicators with a view to assessing patient safety. The OECD and the EC thus agreed to support the on-going development and use of international patient safety indicators.

The general objective of this direct grant was to improve the ‘action ability’ of the OECD patient safety indicators in EU Member States and OECD member countries, including a focus on expanding the scope, uptake and use of these indicators.

Brief description

The OECD established a set of international patient safety indicators and has regularly collected data from member states over the past decade. Over this period the OECD undertook additional research and methodological development work on these indicators to improve their robustness for international comparison. To achieve its general objective, the action targeted the following specific objectives:

·It provided understanding on the current use of patient safety indicators for quality improvement and performance assessment across EU Member States and OECD member countries, including the key challenges being faced by countries currently not implementing the patient safety indicators and the key barriers and enablers to further use of the indicators in countries with existing programmes

·It used the collected "intelligence" to develop future strategies for broader implementation and more purposeful use of the indicators in improving quality of care in EU Member States and OECD member countries;

·It continued to develop the methodology of the existing safety indicators to improve their utility and amenability for use by EU Member States and OECD member countries.

·It built support for the adoption of additional indicators that broadened the scope of services and/or perspectives on patient safety.

Specific results

The present direct grant focused on strengthening the uptake and use of the following OECD Health Care Quality Indicators and their ‘action ability’ for policy makers:

2.OECD-HWF – Feasibility study for an international survey of health workers’ skills

Background information

Committed under the AWP 2015's call reference on Health Work Force, the study was carried out between September 2016 and August 2017 and received a co-funding of EUR 150 000,00, building on the findings of the previous direct grant agreement "20135201 OECD: Overview of education and training programmes for health professionals in the EU" which included an analysis of recent changes in education and training capacities in the EU and an assessment of skills use and skills mismatch in the health sector.

Brief description

Previously collected data pointed to significant levels of skills mismatch, while no data source provided a sufficient sample size to analyse in depth the level of skills mismatch of different types of health professionals in a way that would allow for robust comparisons between different countries..

The present study explored the feasibility of carrying out a sector-specific survey of the skills of health professionals. For this, it reviewed the status of existing surveys that measure health professional skills, identified gaps where more attention and resources are needed to generate policy-relevant evidence on skills requirements, skills use and skills mismatch in healthcare settings; and proposed feasible approaches to develop and implement skills assessment surveys.

Specific results

The main finding concluded that increasingly, health care demands adaptive problem-solving skills to respond to complex and non-routine patient care issues, as well as complex, multi-disciplinary and frequently stressful working environments. In the coming years, countries will need resilient and flexible health workers who are armed not only with technical and clinical skills, but with cognitive, self-awareness and social skills that will enable them to monitor and assess the situation, make decisions, take a leadership role, and communicate and co-ordinate their actions within a team in order to achieve high levels of patient safety and efficiency as well as assure their own safety and job satisfaction.

The main outputs included the mapping of data needs with existing data sources to identify data gaps, the identification of possible options concerning the scope, content and design of a health-specific skills survey as well as possible next steps to move towards its implementation.

3.OECD-EOP – Economics of Prevention 

Background information

Committed under the AWP 2015, the OECD EOP project ran from January 2017 to December 2018 with a maximum co-funding of EUR 600 000.

Brief description

The general objective of this project was to assess the positive and negative economic impacts of obesity and harmful alcohol use in terms of health care expenditures, other public and private expenditures, and broader economic costs. The geographical scope of the project included European Union Member States as well as other OECD member countries, although the Action’s analytical framework was designed to be more widely applicable, both geographically and to other risk factor and disease areas (e.g. tobacco use; environmental risk factors; etc.).

Central to the project were five major components: (1) the review of existing models and conceptual frameworks used to estimate the economic impacts of obesity, harmful alcohol use and associated diseases; (2) the empirical estimation of economic impacts for European Countries in terms of health care costs; other direct consequences; labour market outcomes; economic impacts of welfare benefits; morbidity and mortality costs; (3) the assessment of impacts on human capital and educational outcomes by linking school performance with obesity, physical activity and alcohol use, based on the HBSC (Health Behaviour in School-aged Children) survey; (4) the assessment of the potential of selected public health policies to mitigate the economic impacts of obesity and harmful alcohol use, based on a micro simulation model currently being developed by the OECD; and (5) Production of country profiles in which key country-specific data and findings for individual countries will be collated and summarised in a standardised format.

Specific results

The project established a model to evaluate the burden of Alcohol and BMI and the impact of innovative policy options. The novel OECD micro simulation platform is designed to model the impacts of behavioural and metabolic risk factors on chronic diseases and longevity, as well as the extent to which specific policies can modify these impacts. The model created synthetic life histories from birth to death. Quantitative estimated of the future global burden of chronic non-communicable diseases (NCDs) in the EU and policy impact (2016-2050) can be simulated.

There has been growing interest and support of these results by national health policy makers, as well as ministries of finance. This work directly supports higher government decision making, by addressing (and modelling) economic consequences when trading-off various prevention and related policies. For further information, please visit OECD's website 19 .

4.IOM - RE-HEALTH - Support Member States under particular migratory pressure in their response to health related challenges

Background information

The one year direct grant agreement with the acronym Re-HEALTH: Support Member States under particular migratory pressure in their response to health related challenges was submitted by IOM 20 Regional Office for Europe. This action supports the implementation of key Commission Strategies Actions under thematic priority "Support Member States under particular migratory pressure in their response to health related challenges".

Brief description

The aim of the action was to provide support to EU Member States under migratory pressure to address the health related issues of arriving migrants while preventing and addressing possible communicable diseases and cross-border health events through strengthening national and cross-border disease surveillance and response capacities, in particular at the designated hotspots and in the key areas of reception of refugees and other migrants.

Specific results

RE-HEALTH work resulted in the following 1) establishing links between the hotspots and the health systems; 2) making use of the established handbook to check the health status and needs of the arriving refugees and other migrants, to ensure that health assessments and preventive measures are provided (incl. vaccinations), 3) taking into account the needs of children and other vulnerable groups; and 4) ensuring that data initially collected in the handbook are kept in a database in order to be available at the destination country.

CALLS FOR TENDERS

1.SERVICE CONTRACT: Life Table Analysis: health system cost effectiveness assessments across Europe 

Objective

The objective of the contract was to standardise the methodology used for carrying out health-system cost-effectiveness assessments in the EU-27 Member States, Croatia and the EEA countries (Iceland, Norway and Liechtenstein) with the view to highlight the potential impact of changes in lifestyle habits. The duration of the contract was 12 months from 15 April 2013 with a price of EUR 245 334,00 and an additional EUR 4 500 of reimbursement of expenses.

Description and results

The study aimed to disentangle some of the complexities inherent to health-system performance measurements at population level by standardising both input (expenditure) and outcome (life expectancy) indicators for the prevalence of population lifestyle factors, i.e. apply epidemiologic weighting techniques to improve the comparability of observations made at the Member State level. This way, a corrected (and more importantly, simplified) average cost-effectiveness measure could be calculated (money spent per life year), on which to base cross-country comparisons Further, based on assumed scenarios for changes in population lifestyle incremental cost-effectiveness estimations were also made (extra money spent/saved per added life year).

The study covered the 27 EU Member States plus Croatia, Iceland, Liechtenstein and Norway, as well as the EU area as a whole. The output of the study was a picture of the potential impact that changes in lifestyle habits could have on health expenditure and health outcomes.

The result was an improvement on the state of the art knowledge in this field: in other words, the application of the revised methodology on the selected data sets enables better cross-country comparisons and can help Member States learn from each other.

The results are available in the final report available on the DG SANTE website 21 .

2.SERVICE CONTRACT: The review and mapping of continuous professional development and lifelong learning for health professionals in the EU

Objective

Falling under the field of health information, the present study, concerning the review and mapping of continuous professional development and lifelong learning for health professionals in the EU (also called the CPD study) was commissioned to a consortium led by the CPME, the standing committee of Europeans doctors.

Description and results

There is widespread recognition of the importance of continuous professional development and life-long learning of health professionals. These help to ensure that professional practice is up-to-date and to contribute to improving patient outcomes and increase public confidence in the professions. National interpretations offer a rich scope of differing approaches and present opportunities for the identification of recommendations and best practices in the EU.

This study comprises a unique mapping and review of continuous professional development and lifelong learning for doctors, nurses, dentists, midwives and pharmacists in the 28 member countries of the EU and EFTA countries. It describes the policy background to the topic, reviews available literature and illustrates the outcomes of a Europe-wide survey and expert workshop, as well as presenting an overview of EU and European-level initiatives on continuous professional development. The study identifies policy recommendations to strengthen the exchange of cooperation and best practices at European level and highlighting the need to make efforts allowing all health professionals to undertake continuous professional development, including addressing the main barriers identified, these being a lack of time and resources. The recommendations also call for more research into continuous professional development and its relation to patient safety and quality of care. For the full document with its result, please follow this link .

3.SERVICE CONTRACT: Recruitment and Retention of the Health Workforce in Europe 

Objective

The study concerning in the field of health information the Recruitment and Retention of the Health Workforce in Europe (RR-HWF) has been commissioned to a consortium led by the EHMA, the European Health management association.

Description and results

Many EU countries report both difficulties in retaining and recruiting health staff frequently allied with the challenge of balancing the right number of healthcare staff with the right skills in the right geographical areas to meet the changing needs of populations and health systems. These problems are becoming increasingly urgent as the healthcare demands increase, the health workforce shrinks, with many workers reaching retirement age, risking the future sustainability of Europe’s health systems and access to care.

This study funded under the EU Health Programme included: a literature review, a mapping and review of recruitment and retention practices for health professionals; eight case studies addressing recruitment and retention of health professionals and policy and management recommendations for policy makers, managers, health professionals, researchers and educators. The findings from the study identified many innovative solutions to the challenges of recruiting and retaining health staff.

For the full document with its result, please follow this link 22 .

4.SERVICE CONTRACT: EUREST - Study on the development of an EU common reporting format for submission of data on ingredients contained in tobacco and related products, and disclosure of the collected data to the public

Objective

The EUREST study ran from 11 May 2014 for 11 months, and incurred a total cost of EUR 180 680.

One key aspect of the current Tobacco Products Directive (2014/40/EU) (TPD) is the development of an EU common reporting format for submission of data on ingredients contained in tobacco and related products and disclosure of the collected data to the public.  The Tobacco Products Directive seeks to further harmonise the approach on ingredients regulation in the context of the internal market and to rationalise the reporting system for manufacturers and importers. In this sense, it provides for a common and standardised electronic reporting format for all Member States for the reporting of a list of all ingredients (Article 5), including tobacco, additives, and any other substance or element present (Article 2(18)) in a finished tobacco product. The Tobacco Products Directive also provides for a common electronic notification format for electronic cigarettes and refill containers (Article 20).

In order to make the Tobacco Products Directive fully operational and to keep up with future trends in the tobacco sector, delegated and implementing powers were foreseen to amend or supplement the Tobacco Products Directive and to give effect or 'shape the rules' laid down in the basic act. Accordingly, the Commission shall, by means of implementing acts, lay down the common format for the submission and the making available of the required information on tobacco products (Article 5(5)), as well as the common format for the notification of the required information on e-cigarettes and refill containers (Article 20(13)).

Description and results

This study rose to the challenge by examining the reporting formats previously used in the EU and other jurisdictions while investigating current needs. This involved outlining the strengths and weaknesses of available formats, along with best practices and cost/benefit projections for each format. The study’s results paved the way for the creation of a common EU format for reporting tobacco product ingredients and the notification of e-cigarettes. The final and main deliverables of the EUREST project include a) two data dictionaries that incorporate the domains to be reported within the common reporting format for tobacco products and common notification format for e-cigarettes respectively and b) the pilot submission platform that is built on the aforementioned data dictionaries and facilitates the electronic submission of the data. These helped to deepen EU authorities' knowledge of these products and their effects, strengthening their monitoring capacity and ability to take action. The full document with its result can be found on the website of the European Commission's DG Health and Food Safety . 23 EUREST acted as the base on which EUREST-PLUS (European Regulatory Science on Tobacco: Policy implementation to reduce lung diseases) was developed, a project funded by DG RTD under the 2015 GACD call on lung diseases.

5.SERVICE CONTRACT: Tobacco tracking & tracing 

Objective

Considerable volumes of illicit tobacco products find their way in the EU every day. The availability of such products in the market doesn't only undermine the protection provided for by tobacco control legislation; it also has a direct and indirect adverse impact on public health: direct, as illicit products constitute a public health hazard; indirect, as they undermine related tax receipts, a key financial resource for health systems.

Under the full title "Analysis and Feasibility Assessment Regarding EU systems for Tracking and Tracing of Tobacco Products and for Security Features", the purpose of this study was to assist the European Commission in the preparation for a European Union tracking and tracing system of tobacco products and for security features, as foreseen in the Tobacco products Directive.

The study ran from 28 November 2013, until January 2015, with a total cost of EUR 297 811. Eurogroup Consulting Portugal – Consultoria em gestão, LDA prepared a feasibility assessment regarding EU systems for tracking and tracing of tobacco products and for security features (hereafter "the Feasibility Study").

Description and results

The Feasibility Study reached the conclusion that full traceability of EU tobacco products is achievable and that there are many solutions for security features that meet the Tobacco Products Directive requirements. It thus presented four potential solutions for traceability and four for security features, each one reflecting the basic requirements made under the Tobacco Products Directive, i.e. a unique identifier must be affixed to a unit packet at the manufacturing site, while information on a unique identifier along with additional information required by Article 15(2), which are generated during production and distribution of tobacco products, must be saved at an independent data storage facility. The proposed traceability solutions are as follows:

Option 1: an industry-operated solution, with direct product marking carried out by tobacco manufacturers; manufactures are free to select an independent data storage provider.

Option 2: a solution operated by a third party responsible for the product marking process on the production line; the system operates with one central independent data storage provider.

Option 3: each Member State selects between Option 1 and 2 regarding the entity responsible for product marking (manufacture or independent solution provider); the system operates with multiple independent data storage providers.

Option 4: a unique identifier is integrated with a security feature and affixed in the same process as a security feature; the system operates with (a) independent data storage provider(s).

With regards to the solutions for security features, each option includes several levels of protecting features: overt, semi-covert, covert and forensic. On the basis of various available technologies the Feasibility Study proposes the following four options:

Option 1: a security feature using similar authentication technologies to a tax stamp.

Option 2: reduced semi-covert elements as compared to Option 1, where the co-presence of a unique identifier is regarded as equivalent to the semi-covert level of protection.

Option 3: the fingerprinting technology is used for the semi-covert and covert levels of protection.

Option 4: a security feature is integrated with a unique identifier.

The Feasibility Study concluded that no matter which traceability and security feature option is selected, the benefits clearly outweigh the costs from both economic and social perspectives. However, it also recognises that the above options may vary in terms of the likelihood of achieving the full benefits expected from the introduction of traceability and security features. 

The feasibility study was the first step in a series of actions (including other studies, as the "Implementation Study" ) launched to assist the Commission in drafting secondary legislation on traceability for tobacco products, on related data storage contracts and on security features applied to tobacco products.

The feasibility study was published on 7 May 2015 and can be found on the website of the European Commission's DG SANTE website.

6.SERVICE CONTRACT: Economic landscapes of human tissues and cells for clinical application in the EU

Objective

The study on the Economic landscapes of human tissues and cells for clinical application in the EU ran from December 2013 to May 2015, and was carried out by a consortium led by Rathenau Institute. The total price was EUR 300 000.

Description and results

The safe and stable supply of tissues and cells for patients requiring transplantation is a key priority for national health authorities and the European Commission alike. Voluntary and unpaid donation are governing principles in this field, as laid down in EU legislation (Directive 2004/23/EC) and promoted by international organisations such as the WHO and Council of Europe.

At present, the main concerns are to maintain an adequate supply of tissues and cells for patients requiring transplantation and to warranty their safety and quality. The field of tissues and cells contains three sectors:

·Replacement tissues, such as bone, cornea, skin and cardiovascular tissues

·Hematopoietic progenitor cells from bone marrow, peripheral blood and cord blood

·Gametes and tissues for assisted reproductive technology

This study mapped the economic landscapes and key players in the field of transplantation medicine across the three respective domains across all EU-28 Member States. The study focused on identifying current and emerging economic practices, key players in public and private sectors, legislative and reimbursement schemes across Member States, and finally on providing a forecast of technological trends and of associated ethical, legal, and social issues.

The final report provides insight into the following aspects:

·The characteristics of the EU tissues and cells economic landscape, such as steps from donor recruitment through donation, procurement/collection, testing, processing, storage, distribution to clinical application. This section covers quantities, prices, the extent and ratio of Voluntary and unpaid donation versus paid donations, concerns and conflicts, supply and demand volumes and other elements in order to better understand the economic parameters and dynamics

·The main actors involved in the different steps from donor recruitment to transplantation, for the EU-28 Member States, but also at the EU level, covering public and private actors in this sector

·Regulations on reimbursement and financing in the EU Member States to better understand the various models of organization of reimbursement, the overall costs for tissue transplantation, including transplant tourism. This includes also compensation schemes for donors

·A forecast for the EU economic landscape and trends for tissue and cells for transplantation and assisted reproduction for the next 10 years, with respect to economic, medical, social, political and ethical evolutions in the different sectors within the field of tissues and cells markets. This includes the impact of future technological developments and their respective needs for legal provisions to warranty safety and quality of tissue transplantation.

The final report was published on this link 24 .

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

1.Dissemination activities carried out in 2015

The need to improve the outreach of the Health Programme with more and better targeted in scope dissemination actions was highlighted in the final evaluation of the second Health Programme. In response, CHAFEA organised several workshops, collaborated in major national and international conferences, or organized stand-alone events in collaboration with EU Member States national authorities.

It further participated with the Health Programme's pop-up stands and dissemination material in more than 20 events, of national or EU dimension. The following events can be highlighted:

A two-day workshop on Chronic Diseases and Healthy Ageing (CD-HA) took place on February 2015, in The Hague, the Netherlands. Organised in collaboration with the Netherlands Enterprise Agency and Ministry of Health, Welfare and Sport, it brought together 115 participants, mainly policy makers and experts from 6 EU countries (Belgium, France, Germany, Ireland, UK and Spain).

A Conference on Mental Health in All Policies, titled "Supporting sustainability and growth in Europe"  was held in Helsinki in May 2015, with the support of the Finnish Ministry of Health and Finland's national association for mental health. The meeting brought together more than 150 experts, policy makers and stakeholders from 7 Member States (Finland, Norway, Sweden, Denmark, Estonia, Latvia and Lithuania).

Two workshops and a symposium were organised in the framework of the Addictions 2015 conference, in September 2015, Lisbon, Portugal, organised by SICAD (Serviço de Intervenção nos Comportamentos Aditivos e nas Dependências), in collaboration with EMCDDA, DG SANTE and DG HOME. The aim of the workshops was to discuss progress and challenges in providing health interventions such as prevention, harm reduction and treatment for addictive substance-related problems, with a total of 101 participants 25 .

In addition, CHAFEA contributed to the final dissemination conference of the Joint Action Achieving Comprehensive Coordination in Organ Donation throughout the European Union (JA ACCORD) on organ donation implemented by Member States, held in Madrid on 2 June 2015, where the achievements of EU-wide collaboration in this area were presented also to the press.

CHAFEA organised a full day workshop in the framework of the 8th European Public Health Conference, showcasing the contribution of the Health Programme co-funded actions in the area of health systems as identified in the communication on effective, accessible and resilient health systems . Bringing together more than 80 experts, health professionals, policy makers and project leaders the event also highlighted the role played by public health professionals in sharing experiences and transferring knowledge across the EU.

Following the publication of the 2015 work programme, CHAFEA contributed to 15 national or regional information day events in the countries participating in the Health Programme. It also held three National Focal Point meetings.

The final versions of the thematic, so-called "info sheets", covering important areas of the Health Programme (English versions) have been delivered and are available in several EU languages on CHAFEA's website 26  .

Two brochures were also finalised: one on the joint actions and the other covering all the actions co-funded in 2013.

Finally, so as to better plan its dissemination activities, those funded by the Health Programme operational budget, or from CHAFEA's administrative budget, the Agency launched a tender to develop a comprehensive communication and disseminations strategy for the years to follow (covering the remaining duration of the third Health Programme in 2020).

2.Other Actions 

Scientific Committees

In 2015, a total of EUR 240 991 EUR was provided under the Third Health Programme to part-fund the activities of the non-food Scientific Committees SCHER (Scientific Committee on Health and Environmental Risks) and SCHENIR (Scientific Committee on Emerging and Newly Identified Health Risks). The third Committee, the SCCS (Scientific Committee on Consumer Safety), was funded under the Consumers Programme. These Committees are managed by the Directorate-General for Health and Food Safety.

The purpose of the Committees is to assist the Commission by providing it with sound scientific advice when preparing its policies and proposals related to consumer safety, health and the environment, and draw its attention to new and emerging problems.

The two Committees SCHER and SCHENIR produced the following Opinions in 2015:

-SCHER Opinions

-New conclusions regarding future trends of cadmium accumulation in EU arable soils

-Opinion on Chromium VI in toys

SCHENIR Opinions:

-Opinion on the safety of surgical meshes used in uro-gynaecological surgery

-Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk

-Opinion on the safety of dental amalgam and alternative dental restoration materials for patients and users

-Opinion on the safety of the use of bisphenol A in medical devices

-Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices

-Opinion on potential health effects of exposure to electromagnetic fields

Joint SCCS/SCHER/SCHENIR Opinions:

-Final opinion on Synthetic Biology III - Risks to the environment and biodiversity related to synthetic biology and research priorities in the field of synthetic biology

-Final opinion on Synthetic Biology II - Risk assessment methodologies and safety aspects

The Programme also provided EUR 201 600 EUR to help fund the scientific and technical assistance provided by external contractors. This assistance included organising scientific hearings and thematic workshops, performing literature searches, proofreading, editing and translating scientific texts into publications for the general public and updating the scientific committees’ website.

In December 2015, the Secretariat organised a Conference on Synthetic Biology, following the publications of the 3 joint Opinions.

Expert Panel of Health

An Expert Group on Health Systems Performance Assessment was established in November 2014. In 2015 the Group focused on the assessment of quality care.

Expert Panel on effective ways of investing in health

The Expert Panel on effective ways of investing in health is an interdisciplinary and independent group established by the European Commission to provide non-binding advice on matters related to effective, accessible and resilient health systems.

The creation of the Panel goes back to the conclusions on health systems adopted in June 2011 by the Council of Ministers of the EU, which invited the European Commission to initiate a process to provide with independent and evidence-based advice on health systems related questions is crucial in order to support policy making on health.

Since starting its activities on 11 July 2013, the Expert Panel has been working consistently on topical questions issued by the Commission. The opinions of the Expert Panel present the views of the independent scientists who are members of the Expert Panel. They do not necessarily reflect the views of the European Commission.

The areas of competence of the Expert Panel include, but are not limited to, primary care, hospital care, pharmaceuticals, research and development, disease prevention and health promotion, social protection, cross-border cooperation, health economics, eHealth and health education and literacy.

The Expert Panel delivers opinions, which can support health policy making in the EU. These opinions are for the consideration of the Member States' governments and authorities in charge of delivering healthcare. They are also for the consideration of various stakeholders. They aim at generating discussions at EU and national level with a view to inform policy making. They have all a particular focus on the added value that the EU level can bring through mutual learning, best practice identification and knowledge brokering.

The first three-year term of the panel ended in May 2016. The renewed panel of 14 members was appointed in November 2016, and it serves a three-year term, ending in May 2019.

List of Expert Panel opinions in 2015:

·Cross-border Cooperation

·Competition among health care providers in the European Union - Investigating policy options

IMPLEMENTATION OF ANNUAL WORK PROGRAMME 2015

CALLS FOR PROPOSALS

Calls for proposals — for projects and operating grants actions —were launched on 5 June 2015 on the Participant Portal of the Horizon 2020 Programme, 27 the public health website on EUROPA 28 and on Chafea’s website. 29 Most applications were received from main partners (namely, leading coordinators) in EU-15 Member States, who accounted for 68 % of project applications, 100 % of operating grant applications, and 100 % of joint action applications. The percentage of new EU MS involved in the joint actions is 46.4% of all partners, whereas for projects it is 39.1%.

Chafea organised a joint action workshop in November 2015 and a joint action quality assurance workshop in February 2016. The National Focal Points for the Health Programme also organised national information days throughout June and July 2015. Guidelines for applicants were made available on the Participant Portal. The Chafea helpdesk also provided assistance and practical help.

Altogether, 79 proposals for projects and 15 operating grant proposals were received with a proposal budget amounting for a total EUR  200 088 946.14; however the annual available budget was EUR 13 650 000.00. Of these, 1 was ineligible, 2 inadmissible, 1 withdrew. As an outcome, 29 of the 79 remaining applications (46 were rejected) were funded (37 %). Applications were evaluated in accordance with the rules and criteria set out in Commission Implementing Decision C (2014) 3383 and the calls for proposals. 19 external experts from 14 countries took part in the evaluation process. The experts were drawn from a list established following a call for expressions of interest entitled ‘call for expressions of interest in the area of public health’. 30

The evaluation process took place in two stages.

In the first stage, three external evaluators reviewed each proposal. 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 and from Chafea. The award decision for projects 31 and operating grants 32 were taken by Chafea.

Project grants

Project grants were awarded to actions involving several partners, usually public health bodies and non-governmental organisations. 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 2015, 2 projects qualified for exceptional utility as presented in the 2015 work programme 33 .

In all, 79 proposals were submitted in response to the call for proposals for projects. 29 proposals were recommended for funding and 9 were placed on a reserve list. In the end, 12 projects were funded for a total of EUR 14 944 000,04. Their distribution among the programme objectives was as follows:

1.Health promotion: EUR 2 922 735,89 (4projects)

2.Health threats: no project call

3.Health systems: EUR 3 395 207,18 (2projects)

4.Better and safer healthcare: EUR 1 456 597.00 (2 projects)

In addition and in line with the amended 2015 work programme, 4 projects were funded to support Member States to migratory pressure in their response to health related challenges. The co-funding amount was EUR 6 234 199.58

The table lists all projects funded per objective and thematic priority.

Operating grants

Operating grants were awarded to non-profit organisations or networks that are:

·Non-governmental

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

·Working in the public health area

·Play an effective role in civil dialogue processes at Union level

·Pursue at least one of the specific objectives of the Programme

·Active at Union level and in at least half of the Member States; and

·Have a balanced geographical coverage of the Union

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 2015, only 6 operating grants qualified for exceptional utility.

With the start of the third Health Programme, Chafea introduced the call for multi-annual ‘framework partnership’ instrument. The holders of three-year framework partnership agreements can apply for annual co-funding. The 2015 annual work programme did not foresee an open call for operating grants, as organisations having signed a Framework Partnership Agreement covering the period 2015-2017 were invited to submit their Specific Grant Agreement proposals. 14 applicants were granted a Framework partnership agreement. However, only 13 applicants received a specific grant agreement. At the end of 2015, the grant preparation process was completed representing a volume of EUR 5 005 520. One of the framework partnership agreement holders could not submit their specific grant agreement proposal for 2016 due to the bankruptcy of the legal entity hosting the specific network of experts.

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

Joint actions

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. In 2015, none of the joint actions qualified for exceptional utility.

The procedure for joint actions under the new Health Programme has changed. In order to assure more transparency and inclusiveness, the Member States and countries participating in the Third Health Programme nominate the competent authorities or other bodies as a first step. In the second step, those nominated are invited to submit a proposal under the direct grant procedure.

Four joint actions were co-funded for a total of EUR 17 791 725.60. They were distributed among the programme objectives as follows:

·Health promotion (no joint actions)

· Health threats (no calls)

·Health systems (3 joint actions): EUnetHTA Joint Action 3 - European Network for Health Technology Assessment (EUR 11 999 798.74); Joint Action JAMS - Market surveillance of medical devices (EUR 849 487.69); Joint action ADVANTAGE on Managing Frailty: A comprehensive approach to promote a disability-free advanced age in Europe: the ADVANTAGE initiative (EUR 3 442 591.13)

·Better and safer healthcare (1 joint action): JARC - Joint Action on Rare Cancers - (EUR 1 499 848.04)

These joint actions each involved between 10 and 45 beneficiaries from across the EU 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

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, 10 direct grant agreements were signed, for a total of EUR 3 835 747.29 as follows:

Seven direct grant agreements were signed by Chafea for EUR 3 715 000, namely:

1)5 direct grants were signed with the OECD regarding economics of prevention, Health Report 2016, health workforce, antimicrobial resistance, and data analysis of data patient safety

2)1 direct grant was signed with IOM to support Member States under particular migratory pressure in their response to health related challenges

3)1 direct grant was signed with COE EDQM for the European Pharmacopoeia 2016 Activity Programme (CoE – EDQM)

3 were signed by DG SANTE for EUR 120 747.29, namely:

1)1 direct grant was signed with the Department of Health in Ireland on the inventory on Morbidity Statistics at national level

2)1 direct grant was signed with the "Statistisches Bundesamt" in Germany on the inventory on Morbidity Statistics at national level

3)1 direct grant was signed with the "Centraal Bureau voor Statistiek" in the Netherlands on Health Care Non Expenditure Statistics to support countries in their capacity to provide data on health care

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

Presidency Conferences

In 2015, SANTE together with the Luxembourgish Presidency, organised the high-level Presidency Conference: "Making Access to Personalised Medicine a Reality for Patients". Both public health and examples of EU- and US-funded research initiatives were discussed. Its main findings contributed to the Council Conclusions adopted by the Council of Health ministers on 8 December 2015.

The second co-funded conference, under the Netherlands Presidency of the Council, addressed the challenges of tackling antimicrobial resistance as a major cross-border health threat. Bringing together health and agriculture ministers, it emphasized the “one-health” approach. By drawing on a mix of disciplines including human and animal health, the environment and agriculture, it was instrumental to the adoption of the Council conclusions of 17 June 2016 and the EU One Health Action Plan against AMR.

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 service contracts cover needs as specified in the work plan for 2015:

·Evaluation and monitoring of actions and policies

·Studies

·Advice

·Data and information on health

·Scientific and technical assistance

·Communication

·Dissemination

·Awareness-raising activities; and

·It applications to support policies

In 2015, DG SANTE signed several service contracts and specific requests using existing framework contracts. Most of these contracts and requests were for horizontal actions such as communication and IT services for maintenance and functioning of existing IT tools (i.e. the EMP database, EUDAMED, Health Policy Platform, etc.).

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 2015 was EUR 5 744 988.82.

The overall public procurement budget implemented by Chafea under AWP 2015 was EUR 5 890 424.70. In 2015, Chafea managed 11 new market procedures for the acquisition of services (2 contracts under health promotion, 3 contracts under health threats, 2 contracts under health systems, 2 under better and safer health care) and 2 on horizontal communication.

The amounts per objective and authorising organisation were as follows:

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

Other actions

EUR 1 445 177.4 was earmarked for other actions in 2015. The ‘other actions’ include experts’ fees, for example:

·The expert panel on effective ways of investing in health

·For experts carrying out system inspection on pharmaceutical ingredients

·For experts participating in the international conferences on the harmonisation of technical requirements for the registration of pharmaceuticals for human and veterinary uses

This also includes cost of administrative agreements with the Joint Research Centre and covers the Commission’s membership fee to the European Observatory on Health Systems and Policies. For more information on what specific actions fell under the banner ‘other actions’ (please see the table below for further reference).

DETAILED OVERVIEW OF THE REPORTING YEAR

1.Funding per thematic priority and financial instrument

(1)

  http://ec.europa.eu/CHAFEA/health/index.html  

(2)

  http://www.epirare.eu/del.html

(3)

  https://webgate.ec.europa.eu/CHAFEA_pdb/health/projects  

(4)

A Rare Diabetes Syndromes microarray capable of identifying up to 600 different mutations was created and used across all participating centres

(5)

  https://www.orpha.net/consor/cgi-bin/index.php  

(6)

  http://www.euro-wabb.org/en/  

(7)

  https://webgate.ec.europa.eu/CHAFEA_pdb/health/projects  

(8)

  https://webgate.ec.europa.eu/CHAFEA_pdb/health/projects  

(9)

  http://www.sialon.eu/en/  

(10)

 Médecins du Monde also received EU co-funding under the health programme through the award of an operating grant, covering the years 2015-2017, in support of the European network to reduce vulnerabilities in health , bringing together NGOs and academic partners from 17 EU Member States and 2 EFTA/EEA countries.

(11)

  http://www.medecinsdumonde.org/fr/populations/migrants-deplaces

(12)

  http://www.easp.es/sh-capac/  

(13)

  http://eur-human.uoc.gr/about/  

(14)

  https://webgate.ec.europa.eu/CHAFEA_pdb/health/projects  

(15)

  http://careformigrants.eu/the-project/  

(16)

  https://webgate.ec.europa.eu/CHAFEA_pdb/health/projects  

(17)

One of the 14 applicant organisations awarded a Framework partnership agreement became bankrupt in 2015.

(18)

  https://www.rareconnect.org/en  

(19)

  https://www.oecd.org/fr/sante/economics-of-prevention.htm

(20)

 The financial decision implementing Work Programme 2015 (COM/2015/C/ 3594) and its amendment (COM2015/C 7414) identifies IOM as the recipient for this direct grant agreement and this in accordance with Article 190 (1)(f) of Delegated Regulation (EU) N° 1268/2012.

(21)

  https://ec.europa.eu/health/sites/health/files/systems_performance_assessment/docs/2015_maceli_report_en.pdf  

(22)

https://ec.europa.eu/health/workforce/key_documents/recruitment_retention_en

(23)

https://ec.europa.eu/health/sites/health/files/tobacco/docs/reportingformat_dataingredients_en.pdf

(24)

http://publications.europa.eu/resource/cellar/5a0fd429-4a4e-11e6-9c64-01aa75ed71a1.0001.02/DOC_1

(25)

http://ec.europa.eu/CHAFEA/news/news381.html

(26)

http://ec.europa.eu/CHAFEA/health/hp-infosheets_en.html

(27)

http://ec.europa.eu/research/participants/portal/desktop/en/opportunities/3hp/index.html#c,calls=hasForthcomingTopics/t/true/0/1/0&hasOpenTopics/t/true/0/1/0&allClosedTopics/t/true/1/1/0&+PublicationDate/desc  

(28)

  https://ec.europa.eu/health/funding/programme_en  

(29)

  http://ec.europa.eu/CHAFEA/health/index.html  

(30)

OJ S 040-065407, 26.2. 2014 and http://ec.europa.eu/CHAFEA/ami/  

(31)

  http://ec.europa.eu/CHAFEA/documents/health/list-projects-2014_en.pdf  

(32)

  http://ec.europa.eu/CHAFEA/documents/health/award-fpa-agreements-2014_en.pdf and http://ec.europa.eu/CHAFEA/documents/health/specific-grant-agreements-2014_en.pdf

(33)

  https://ec.europa.eu/health//sites/health/files/programme/docs/wp2015_annex_en.pdf  

(34)

  http://www.eu2015lu.eu/en/agenda/2015/07/08-conf-medecine-personnalisee/index.html