EUROPEAN COMMISSION Brussels, 11.10.2017 SWD(2017) 331 final COMMISSION STAFF WORKING DOCUMENT Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS

Mid-term evaluation of the third Health Programme



Regulation No 282/2014 on the establishment of a third Programme for the Union's action in the field of health (2014-2020)

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1.2Scope of the evaluation The mid-term evaluation of the third Health Programme covers the first three years of Health Programme implementation (2014 - 2016). It examines the relevance of the choices made in the Annual Work Plans 2014, 2015 and 2016 and the decisions on proposals submitted and awarded for EU funding under the subsequent calls. Moreover, the evaluation covers the efficiency of the use of resources, the EU-added value of the Programme, the internal and external coherence, and potential for simplification. The evaluation focussed especially on either new or previously under-examined aspects, such as the Annual Work Programmes, the multi-annual planning and the exceptional utility criteria. 1.BACKGROUND TO THE HEALTH PROGRAMME 2014-2020 2.1 Description and objectives The Health Programme 2014-2020 is the third programme of EU action in the field of health, established by Regulation (EU) 282/2014. With a budget of EUR 449.4 million over seven years, it is the Commission's main instrument to underpin and support EU health policy development. Designed to help Member States in investing in health, the Programme contributes to the Europe 2020 objective of smart, sustainable and inclusive growth. The Programme aims to complement, support and add value to the policies of Member States, in terms of improving the health of EU citizens and reducing health inequalities. It has four specific objectives which are the following: (a) promote health, prevent diseases and foster supportive environments for healthy lifestyles, (b) protect Union citizens from serious cross-border health threats, (c) contribute to innovative, efficient and sustainable health systems, and (d) facilitate access to better and safer healthcare for Union citizens. These objectives are served by actions on the following 23 thematic priorities, set out in the Annex I to Regulation 282/2014. See also in Annex I of this document. The thematic priorities aim to focus the Health Programme on types of issues and action where the potential to generate EU-added value is greatest and therefore contribute to the Commission main priorities for: (i) ‘growth, jobs and a resilient society’ (health of the population and healthcare services as a productive factor for growth and jobs); (ii) ‘digital single market’ (including eHealth); (iii) ‘internal market’ (for pharmaceuticals, medical devices, cross-border healthcare directive, and Health Technology Assessment); (iv) ‘justice and fundamental rights’ (fighting against health inequalities); (v) ‘migration’ policy, and (vi) security in Europe (preparedness and management of serious cross-border health threats). The Programme is managed by the Commission and implemented through annual work programmes that are adopted following a positive opinion of a programme committee composed of Member States’ representatives. The work programmes are based on a multiannual perspective in order to ensure that all thematic priorities are covered aligned to the available resources, clustering priorities and actions. The implementation is entrusted with the Consumers, Health, Agriculture and Food Executive Agency (CHAFEA). In the Programme participate in addition to the 28 EU Member States, the two EFTA countries Norway and Iceland, Serbia and Moldova since 2016, and recently Bosnia and Herzegovina has joined in April 2017. The increasing interest of candidate countries and potential candidates and neighbouring countries could be seen as a sign of the increasing interest the Programme has for those countries that have decided to align their health policies with those of the EU.

2.2 Expected outputs, results and impacts 2.2.1. Under specific objective 1 for promoting health and preventing diseases, the Programme works for the identification, dissemination, and promotion of an effective uptake of evidence based best practices, including measures to be taken for addressing the health inequalities (migrants, ethnic minorities, refugees and other vulnerable groups). The previous Health Programmes have supported the identification of a considerable number of best practices related to a big number of health issues such as the promotion of healthy lifestyles, the prevention and management of non-communicable diseases and chronic conditions, the patient safety, etc. The third Health Programme does not limit itself to identifying new best practices but rather makes the step further to organise the existing ones, validates and promotes best practices for direct implementation by Member States that wish to make use of them in their national policies. Article 3 (1) of Regulation 282/2014 provides that objective 1 must be measured, in particular, through the increase in the number of Member States involved in health promotion and disease prevention, using evidence-based and good practices through measures and actions taken at the appropriate level in Member States. Risk factors Baseline: 12 Member States have had a national initiative on the reduction of saturated fat in 2013 Target: By 2020, all EU-28 should have had a national initiative on the reduction of saturated fat. Chronic diseases including cancer Baseline: 0 Member States where the European accreditation scheme for breast cancer services is implemented – establishment of the scheme. Target: by 2020 all EU-28 should have implemented the accreditation scheme for breast cancer services. 2.2.2 Under specific objective 2 for protecting citizens from cross-order health threats, the Programme requires the identification and development of coherent approaches and supports and promotes their implementation for better preparedness and coordination in health emergencies. The Programme brings together and supports competent authorities in addressing a challenge that affects all Member States which in most of the cases can have consequences to the global health and which is best dealt with through cooperation. Supported actions under this objective have served to identify gaps in Member States’ capacities, prioritise actions and implement capacity building activities to fill in those gaps. For example through toolkits and guidelines, simulation and post command exercises. Part of the role of the Health Programme is also to bring together relevant stakeholders to give them an opportunity to revise or agree on emergency procedures, as well as enhancing the evidence base for decision-making which in turn builds capacities. Through the Programme, technical expertise to tackle a specific set of high risk groups (risk group 3 bacteria and risk groups 3 and 4 viruses) has been developed meaning that citizens would be better protected. Article 3(2) of Regulation 282/2014 provides that objective 2 on crisis preparedness and management must be measured, in particular, through the increase in the number of Member States integrating coherent approaches in the design of their preparedness plans. Baseline: in 2014, there was no Member State with integrated coherent approaches in the design of their preparedness plans. Target: by 2020, all EU-28 should have integrated coherent approaches in the design of their preparedness plans. At the time of drafting this document, 16 Member States have reached this goal. Updated indicators are expected to be available after the next reporting exercise by Member States on preparedness and response planning under Article 4 of Decision 1082/2013/EU (to be completed by November 2017). 2.2.3 Under specific objective 3 for contributing to innovative, efficient and sustainable health systems, the Programme identifies and develops tools and mechanisms at EU level to address shortages of human and financial resources and facilitate the voluntary uptake of innovation in public health intervention and prevention strategies. The main ones are the Health Technology Assessment, eHealth, the European Innovation Partnership in Active and Healthy Ageing, the Expert Panel on health and the Commission Scientific Committees.

Article 3 (3) of Regulation 282/2014 provides that this objective must be measured, in particular, through the increase in the advice produced and the number of Member States using the tools and mechanisms identified in order to contribute to effective results in their health systems. Health Technology Assessment (HTA) Baseline: 2 HTA per year Target in 2020: 50 HTA annually involving all EU-28 In 2014 and 2015, respectively 6 and 9 HTA have been developed. For further information on HTA please refer to Annex I part B. 2.2.4 Under specific objective 4 for facilitating access to better and safer healthcare,

the expectations are for increased access to medical expertise and information for specific conditions also beyond national borders and the facilitation of the application of the research results and the development of tools for improved healthcare quality and patient safety through actions contributing to improved health literacy. Article 3 (3) of Regulation 282/2014 provides that this objective must be measured, in particular, through the increase in the number of European reference networks established under Directive 2011/24/EU of the European Parliament and of the Council, the increase in the number of healthcare providers and centres of expertise joining European reference networks, and the increase in the number of Member States using the tools developed. Baseline: 0 ERN Target in 2020 : 20 ERNs . This target has been achieved already in 2017 with the establishment of 24 European Reference Networks (ERNs). Reviewed new target in 2020: 33 ERNs ERNs are expected to deliver a number of benefits over the medium and long-term: provide the 27-36 million people affected by rare diseases, representing 6-8% of the overall EU population, with greater access to high quality health care and information, accurate diagnosis and appropriate treatment. In this first phase (2016-2018), ERNs include 24 networks and almost 1000 clinics across the EU, set up for complex and rare diseases. In the coming years the concept of ERNs could also cover other complex diseases such as more common cancers or specialised paediatric interventions if resources are made available. This will result in better chances for patients to receive an accurate diagnosis and advice on the best treatment for their specific condition. ERNs are not directly accessible to individual patients. However, with the patients’ consent and in accordance with the rules of their national health system, patient case can be referred to the relevant ERN member in their country by their healthcare provider. By pooling expertise and knowledge, ERNs are able to maximise the speed and scale with which innovations in medical science and health technologies are developed and put into use. Economies of scale can be achieved by connecting existing reference networks found in individual Member States, and greater efficiency and coordination can be achieved by sharing resources and expertise across the EU. Reference networks are also ideal environments for research and innovation (clinical trials, patient registries, training of professionals). 2.2.5 Cross-cutting actions: actions for migrants and refugees: The extraordinary influx of migrants and refugees in 2015 and 2016 was an unpreceded situation and led to unexpected and considerable challenges for Member States health systems providing services to an increased population, sometimes with special health needs. The Health Programme was able to make a meaningful -while proportionate to the Health Programme budget- contribution to the EU policy on migration, particularly on integration, and to the immediate EU response, assisting Member States in their response. Therefore the Health Programme responded to this crisis, through 11 actions financed with over EUR 14 million. The aim was to support countries in their immediate response to health needs, develop and implement roadmaps and models for improving healthcare access of vulnerable migrants and refugees in Europe, increase awareness and commitment towards improving health and healthcare for refugees and migrant, with focus on pregnant women, deliver recommendations, technical guidance, and training to health professionals, law enforcement officers and health mediators working at local level with migrants/refugees. Training at EU level is in preparation, including health professionals, law enforcement officers, social workers, and health mediators and will be provided in 2017-2018. It includes knowledge, attitudes and awareness on migrants needs. A first piloting will take place in 10 EU countries and a second phase will address professionals in the 32 countries of the Health Programme. More specific trainings took place at local level and for the professionals locally involved in some of the funded projects. For example, 494 health professionals and 443 sessions for migrant groups, in one of the projects, 5 trainings on health mediations, 8 training of the health assessment platform and 12 demonstrations, with 71 health mediators and 2 815 migrants reached with awareness raising messages. Online training course packages were also produced, especially for health managers.

Guides for the assessment of health needs of migrants/refugees were produced as well as country profiles and guidelines for the development of action plans. Country missions to Member States were developed. Health assessments have been carried out: In 2015, 4 275 health assessments have been carried out by the International Office for Migration ̶ which benefited from a Health Programme direct grant ̶ and 8 938 assessments were carried out in 2016. After positive assessment, migrants considered able to travel departed to 21 EU countries and 3 EFTA countries. 1586 personal health records, aiming to reconstruct the medical history of the migrants and refugees, were completed, with 685 persons referred for additional medical diagnostics. In another project, 2 459 urgent individual health assessments were done with newly arrived migrants and 49 707 physical health assessments, 1 775 mental health ones and 4 811 social consultations, 12 mobile teams were deployed in 9 countries. In a third project, 11 057 medical examinations were performed in Italy. Protocols for age assessment into hotspots were developed, as well as a syndromic surveillance system. 2.METHODOLOGY 3.1 Preliminary steps An Interservice Steering Group for the mid-term evaluation established in October 2015, discussed and validated the Roadmap for the mid-term evaluation which was open for public consultation for four weeks (14/12/2015-14/01/2016) . On the basis of this Roadmap and feedback from Member States and non-governmental organisations, the Steering Group drafted the evaluation questions and agreed on the terms of reference for the specific contract. Feedback was taken into account, for example, by including one case study on the thematic priority on alcohol policy in the EU or by examining the exceptional utility criterion to see if it really works. This took the form of a specific request for services with a reopening of competition within the Directorate-General for Health and Food safety (DG SANTE) Framework Contract for Evaluations, Impact Assessment and other studies, Lot 1 " Public Health". The independent study started in May 2016 and the final report was delivered a year later. The group met six times to also discuss the inception, interim and draft final reports and provided comments on the methods and organisation of the evaluation. It provided feedback on the quality assessment of the work done and has also been involved in the drafting of the present Staff Working Document which follows the Commission’s Better Regulation rules. 3.2 Process and methods used The evaluation involved a variety of quantitative and qualitative data collection and review methods and analytical tools to respond to specific information needs and requirements respecting the principle of triangulation and the Commission standards for evaluation. Figure 1: Evaluation approach Annex I contains a matrix showing the various tools used to make assessments on the basis of agreed judgment criteria and answer each of the evaluation questions. The evaluation questions are grouped under six categories: 1) relevance, 2) effectiveness, 3) efficiency, 4) EU-added value, 5) coherence and 6) utility. Every category was extensively assessed by the mid-term evaluation through an entire programme assessment, the case studies and the open public consultation. The contractors used desk research to analyse existing sources (e.g. Annual Work Programmes, legislative texts, internal notes, etc.), reviewed conclusions and recommendations from past Programme evaluations and made direct observations. They interviewed key Programme stakeholders including Commission staff and the WHO, CHAFEA project officers and project leaders of funded actions. They also discussed with independent public health experts in the four main relevant areas of the Programme and have conducted e-surveys with the Health Programme National Focal Points and the Members in the Programme Committee. To explore and showcase how actions in the thematic areas are implemented and delivered their specific results, and the main factors and processes that enabled or hindered their success, particularly for aspects such as EU-added value, the contractors have conducted eight case studies on 8 out of the 23 thematic priorities. . The eight thematic priorities for the case studies were selected on the basis of the following criteria: - actions that already started in 2016 and were at the stage of delivering at least an interim report; and - a sample of actions representing the spectrum of all the different financial mechanisms (e.g. operating grants have not been examined in previous evaluations).

The detailed list with the selected priorities and actions can be found in Annex II, table 2. Then an open public consultation carried out by the Commission has served to test preliminary conclusions and recommendations. The on line public consultation which took the form of a questionnaire was available from 23 November 2016 to 23 February 2017. The public consultation was available in English, however replies could be sent in any of the official languages of the EU. A total of 133 contributions were received mainly from individuals/private persons (32%), non-governmental organisations (29%), relevant to health public authorities (19%), academic organisations (9%), international organisations (9%) and professional associations (8%). The results of the open public consultation are published with a synthesis report at http://ec.europa.eu/health/programme/consultations/midterm_evaluation_en A synopsis report on stakeholders’ consultation activities can be found in Annex V of the present document. 3.3 Limitations – robustness of findings The mid-term external evaluation study was launched in late April 2016 in order to deliver by 30 June 2017. Therefore the evaluation came at a quite early stage in the implementation phase of the Programme: external contractors have had access to the 2014 Programme data; however the second year of Programme implementation (2015) was still in progress while for the third year (2016) the calls were published but the awarding decision was not yet taken. Therefore only partial financial data were available for 2016. This limits the focus of the evaluation to actions from the Annual Work Programme 2014 and in part for 2015. The actions assessed are mainly those having a short duration of only one year (meaning small actions, such as grants to NGOs for support to migrants and refugees or operating grants to NGOs and service contracts for studies). Actions with longer time schedule and bigger potential to contribute to the Programme objectives such as the Health Technology Assessment Joint Action (EUR 12 million) in 2016-2020 had only just started and therefore it was too early to assess them. For this reason, the independent study was from the outset called to focus mainly on effectiveness of the Programme management rather than the effectiveness of the Programme actions. Furthermore, improvements addressing problems of monitoring and dissemination raised in the ex-post evaluation of the second Health Programme that was published in May 2015 and agreed in an Action Plan between DG SANTE and CHAFEA in December 2015, had not yet been fully implemented. Therefore some recommendations in the mid-term evaluation address the same challenges that were already highlighted in the ex-post evaluation of the previous Programme. Other limitations are related to the sheer number and heterogeneity of thematic priorities and individual actions. Progress indicators exist but these exist at the level of actions not at the level of priorities making it difficult to summarise in a quantifiable way how the whole set of actions fits together and contribute to the Programme objectives. 3.4 Quality assessment of the study The Interservice Steering Group agreed with the contractors’ findings, the answers to the evaluation questions and its conclusions within the limitations described above. They approved the final evaluation report and made the following observations: ·The contractors respected the terms of reference and delivered a report on time that was of satisfactory quality. The data they provided are accurate. After several in-depth reviews where the contractor addressed all the issues and further information was exchanged, the report became very clear, legible and precise. On the financial situation of the Programme implementation in 2016, the contractors based themselves on what was actually available as the situation was evolving and made appropriate reference to this kind of limitations. ·The analysis and judgement are based on a clearly explained methodology, the criteria are transparent and the evidence used comes from different sources involving in a balanced way all Programme stakeholders. ·The conclusions are sound and limit themselves to what is feasible at this stage of the Programme implementation. The recommendations flow logically from the conclusions. They are practical, realistic, and addressed to the relevant Programme actors. 3.THE FIRST THREE YEARS OF IMPLEMENTATION OF THE PROGRAMME 4.1 Budget distribution per objective and thematic priority So far, objectives 1 (on health promotion) and 3 (on health systems) have received the highest amount of funding, 33 % and 31% respectively. The rest of the funding was allocated 19 % to objective 4 (access to healthcare), 10 % on horizontal or cross-cutting activities and 7% to objective 2 (cross border health threats).





Table 1: Allocation of budget by objective, 2014 - 2016 Objective 2014 2015 2016 2014 – 2016 1 Promote health, prevent disease and foster supportive environments for healthy lifestyles 31% 23% 43% 33% 2 Protect citizens from serious cross-border health threats 10% 3% 8% 7% 3 Contribute to innovative, efficient and sustainable health systems 33% 45% 16% 31% 4 Facilitate access to better and safer healthcare for Union citizens 20% 11% 26% 19% Horizontal 7% 18% 6% 10% Across the 23 thematic priorities, the funding ranges significantly. The work on migrants and refugees (a major part is under horizontal actions) cuts across several action areas like health inequalities, chronic diseases, mental health, communicable diseases and health information. If looked at as a single entity, action on migrants and refugees represents a public health investment of EUR 14.4 million ( EUR 9.5 million funded under horizontal activities, another EUR 3.5 million under capacity building (priority 2.2) and EUR 1.4 under priority of health information (priority 3.7). With the remaining EUR 7.8 million under horizontal activities, the Programme supports also activities for maintenance and licence of information technologies (e.g. the DG SANTE Web page, the Health Policy Platform), communication on EU health policies and dissemination of Programme results, etc.







Table 2: Allocation of budget by thematic priority, 2014 - 2016 Source: DG SANTE and CHAFEA Note: figures are rounded; 2016 allocated budget is based on available data. *While the funding to thematic priority 2.1 drugs-related health damage appears low, five actions which address among other secondary prevention for drugs users have been funded under the 3HP and are accounted under thematic priority 1.3 HIV/AIDS, Tuberculosis and hepatitis as the main subject was on these communicable diseases.

**While very little funding appears to be allocated to thematic priority 4.4 on antimicrobial resistance, this topic is in fact addressed through some of the action funded through thematic priority 4.3 on patient safety and healthcare quality. ***The scope of health information under objective 2 for health threats relies mainly with the European Centre for Diseases Control (ECDC) mission and this is the reason that no budget has been spent on this priority in the period 2014-2016. 4.2 Budget distribution per financial mechanism The Annual Work Programmes are implemented through various financial mechanisms, which all assist different kinds of actions and objectives. For this implementation, DG SANTE of the Commission is supported by CHAFEA, which manages calls for grants and tenders. The Commission is responsible for the implementation of highly policy-relevant service contracts and cross-cutting actions. In the years 2014 to 2016, EUR 165.6 million euros (36.8% of the total funding) has been allocated in total, of which EUR 53.8 million for 2014, EUR 55.4 million for 2015 and EUR 56.4 million for 2016. The available mechanisms of the third Health Programme are listed below. Table 3: Financial mechanisms of the Health Programme Financial mechanism Description Project grants They are used to fund a collaborative effort between different organisations in various EU MS, which join forces to perform various tasks on a common set of objectives for a defined period of time Operating grants They provide financial support towards the functioning of a non-governmental body or network, over a period that is equivalent to its accounting year, in order to carry out a set of core activities Direct grants to international organisations They are awarded to international organisations, such as the WHO, with the capacities needed to tackle relevant health priorities. Joints actions They have a clear EU added value and are co-financed either by competent authorities that are responsible for health in the Member States or in the participating third countries, or by public sector bodies and non-governmental bodies mandated by those competent authorities Procurement contracts These contracts cover specific needs related to the support of EU health policies (e.g. studies, development of IT tools, etc.) (Also called service contracts or tenders) Presidency Conferences Thematic conferences on health topics such as personalised medicine to mark Presidency of the EU. Others For example: “Payment of membership fee and reimbursement of expert mission costs", "Reimbursement of auditor mission costs", "Cross sub-delegation to EUROSTAT". The total budget for 2014-2016 is split between the seven funding mechanisms. Figure 2 below illustrates how and compares this to the second Health Programme. The largest part of funding is allocated to joint actions (30%), procurement contracts (27%) and projects (24%). Already in the second Health Programme, a progressive shift in funding from projects to joint action was provided, which also applies to this Programme. Smaller proportions of the budget were reserved for operating grants (9%) and direct grant agreements (7%). "Other" mechanisms and conferences took only 2 % and <1 %, respectively, of the total funding in the first three years.

Sources: DG SANTE and CHAFEA The procurement contracts are mainly managed by CHAFEA while a smaller number are sub-delegations, administrative agreements and reimbursement of experts being implemented by DG SANTE. Table 4: Budget allocation between DG SANTE and CHAFEA, 2014 – 2016 2014 2015 2016 TOTAL CHAFEA €44.4 M €48.6 M €47.2 M €140.2 M DG SANTE €9.4 M €6.8 M €9.2 M €25.4 M TOTAL €53.8 M €55.4 M €56.4 M €165.6 M Source: CHAFEA and DG SANTE 4.3 Budget distribution per country In the third Health Programme participate the 28 EU Member States, two EFTA countries (Norway and Iceland), and since 2016 Serbia and Moldova; in 2017 Bosnia and Herzegovina has also signed a bilateral agreement for participation in the Programme. 65% of the total budget for Joint Actions is distributed between seven of the EU 15 Member States (see graph below) and 52 % of the total budget for projects between four Member States (ES, IT, UK and NL). All organisations receiving below of the average funding are from low GNI countries.

4.ANSWERS TO THE EVALUATION QUESTIONS The main conclusions to each of the 16 evaluation questions (EQ) presented in the mid-term evaluation are summarised below. 5.1 Relevance EQ1:To what extent are the 3rd Health Programme objectives still valid and in accordance with health needs in Europe? The Programme objectives are valid and respond to emerging EU needs and evolving challenges. The replies of National Focal Points and Programme Committee members on what is the single most important reason for EU action (as opposed to action at the national, regional or local level) can be summarised as follows: Table 5: Why do Member States need an EU action following the Programme objectives? Objective Most important reason(s) given for EU action by mini-survey respondents 1.Promote health, prevent diseases & foster supportive environments Exchange of best practice and expertise, potential for mutual learning between Member States. At the EU level it is possible to promote activities and engagements that would not otherwise be a priority for national government. Also pooling resources was mentioned. 2.Protect citizens from serious cross-border health threats The fact that communicable diseases are trans-boundary in nature and require a trans-boundary response (the EU can support development of early warning systems which prevent the rapid spread of communicable diseases). 3.Innovative, efficient & sustainable health systems Exchange of best practices and innovation. EU action supports MS especially vis-à-vis eHealth and the EIP on active and healthy ageing. 4.Facilitate access to better and safer healthcare Responses here were wide ranging, somewhat reflecting the objective itself. Reponses ranged from citing specific areas like antimicrobial resistance (AMR) and European Reference Networks where economies of scale can be achieved through EU level action to the establishment of common standards to prevent disease and ensure equal treatment of all EU citizens thus creating greater cohesion among Member States. The Programme is addressing to a large extent the relevant health needs. In comparison to the second Health programme it has increased the focus on issues generating the most EU added value, while remaining flexible to respond quickly to emerging health needs. In some cases and despite the fact that the Programme covers mental health under the priority of chronic diseases, public health experts pointed out the need to have this as a distinguished thematic priority for attracting more attention on the importance of mental health issues. Moreover, the evaluation found that the division in the rationale for action under the objectives is visible. The potential EU-added value is clearest for objective 2 (cross-border health threats) and 4 (access to healthcare), which seems to attract less attention in the Member States but the EU role is clearer in the sense that Member States would struggle to address them on their own. Objective 1 (health promotion) and 3 (health systems) draw larger resources and there the Health Programme can enable the exchange of best-practices and knowledge sharing. EQ2:To what extent are the 3rd Health Programme thematic priorities sufficient and sufficiently covered to achieve the 3HP objectives and Commission wider priorities? The thematic priorities are successful in defining the purpose of the Programme more precisely than its predecessor programmes thus increasing its coherence and focus. They are relevant and reflect well health needs of Member States. They also serve in the need for actions to be more aligned with high priorities of Member States and with wider policy objectives of the European Commission. Not enough Member States health policy documents were available for the evaluators to rank their priorities, but replies from the National Focal Points and the Programme Committee members on the three thematic priorities that are most important for public health in their country in relation to each objective of the Programme together with replies to the Open Public Consultation provided further insights and showed consistency in priorities among stakeholders and also with the real Programme spending.



Objective 1 (health promotion): Risk factors (1.1) and chronic diseases (1.4) are overwhelmingly cited as most important in both surveys. Objective 2 (cross-border health threats) : the most frequently selected as important thematic priorities are capacity building against health threats (2.2), Health information and knowledge systems to evidence-based decision making (2.4) and the Implementation of EU legislation for cross-border health threats(2.3) Objective 3 (health systems): respondents seem to agree that innovation and eHealth (3.2) is the most important in this context. Objective 4 (access to health care): measures to prevent antimicrobial resistance and control healthcare associated infections (4.4) together with patient safety and quality of healthcare (4.3) attract the interest of Member States’ representatives and Programme stakeholders. Stakeholders did not miss any priorities in the list though some wanted more visibility for mental health (currently this is an item under chronic diseases). In the open public consultation other specific areas such as endocrine disruptors in air, soil and water were mentioned that are covered under the environmental programme. On the issue of endocrine disruptors the Scientific Committees financed under the Programme have also issued two opinions. EQ3:To what extent are the actions prioritised in the Annual Work Plans (AWPs) relevant vis-à-vis the 3rd Health Programme's thematic priorities? The Health Programme focused and prioritised actions mainly on chronic diseases in Annual Work Programme 2014, Health Technology Assessment in 2015, and the establishment of European Reference Networks in 2016, while actions for increasing the capacity of Member States to respond to cross-border health threats were continuously supported by the Programme throughout the first three years with a particular focus on the refugees' crisis in years 2015 and 2016. All these actions were supported by substantial budgets and correspond to the four Programme objectives (1) for health promotion and disease prevention, (2) for preparedness and crisis management, (3) for innovative and efficient health systems and (4) for better and safer health. The evaluation examined in the case studies and assessed positively the relevance of these actions and reconstructed the intervention logic of the thematic priorities showing how the actions contribute in the Programme objectives (see in Annex IV). The current structure of the Programme with explicit objectives and relevant thematic priorities serves to ensure the appropriateness of individual actions. The funded actions have shown to correspond to health needs and are built on clear and relevant objectives, especially when a legal basis exists in the fields of their predilection. In this case the action focuses immediately on achieving concrete outputs (e.g. the establishment of European Reference Networks). Otherwise, for broader priorities in fields without legal commitment (e.g. chronic diseases, expert panel on Health) it is necessary to anticipate collective thinking which is conducive to better planning and agreed objectives already in the design phase of the actions.

The choice of the financial mechanism is also an important aspect and in the case of operating grants it became obvious that this financial mechanism enshrined in the Programme Regulation, supports more a mission rather than specific objectives. This means that the relevance of the mission should be assessed and monitoring and evaluation processes should be available for keeping track of how the organisations benefiting from operating grants perform in relation to the health policy priorities. EQ4:To what extent are the actions co-funded through the AWPs relevant to achieving the objectives set out in Article 168 TFEU? This evaluation question was addressed together with evaluation question 15 on the coherence and consistency of the Health Programme. 5.2 Effectiveness EQ5:To what extent is the process for defining and prioritising actions through Annual Work Programmes (AWPs) transparent, equitable and impartial? Each year an Annual Work Programme is prepared by DG SANTE in close coordination with the Member States and adopted through Comitology (examination procedure). The Annual Work Programme identifies the actions, describes the desirable outcomes and results, decides on the financial mechanisms to be used for each of the actions and the criteria for the selection and award of funding. This is the master piece in the successful Programme implementation and the contractors approached the question by examining to what extent the Annual Work Programme is open to scrutiny by the relevant stakeholders (transparency), whether its preparation includes the fair participation of and consideration of actors concerned (equity) and is free from political bias (impartiality). The evaluation found that the formal process for setting Annual Work Programmes is largely transparent, equitable and impartial. The formal consultation process includes two rounds of discussions and a final agreement with the Programme Committee which is comprised of Member States representatives. Draft versions of the Annual Work Programme are presented in time, discussed and voted on, while a summary of the procedure, views expressed and decisions taken is recorded with minutes that are also sent to the European Parliament. Given this is made publicly available, it can therefore be considered to be both well-documented and open to scrutiny. The formal consultation of Member States, CHAFEA and other European Commission departments works well and annually defined priorities synthesize actions in line with current public health needs. The Programme legal basis provides for an informal consultation with the relevant experts, including National Focal Points. This is done from 2016 onwards only with the Programme Committee Members as an informal consultation before the formal Comitology opinion. On this informal procedure there is minor criticism on its transparency and fairness implying that some Member States are more influential than others. The aspects of fairness and transparency in the consultation process are important for the involvement of all countries in the planning process. Some countries feel also that a growing proportion of funding is dedicated to top-down financial mechanisms, such as joint actions and procurement contracts leaving fewer possibilities for Member States to promote their ideas for other actions. Respondents to the open public consultation asked also for greater transparency implying that there is limited awareness of the consultation processes outside the Programme's core stakeholder groups. EQ6:How effective was the Multi-Annual Planning (MAP) for the preparation of the Annual Work Programmes?

The evaluation shows that the Multi-Annual Planning has improved the preparation of Annual Work Programmes. Following recommendations from evaluations of previous Programmes, for the third Health Programme the Commission introduced the Multi-Annual Planning as an internal planning exercise in order to incorporate a more holistic, longer-term mind-set into the programming process. The first Multi-Annual Planning covered the years 2014-2016 (which is the chronological scope of the mid-term evaluation) and explained in an internal note its caveat in planning ahead in the more distant future. A second Multi-Annual Planning exercise was organised in the second half of 2016, covering the remaining years 2017-2020.

The Multi-Annual Planning has contributed to a smoother and faster process for agreeing the Annual Work Programmes. Moreover, it proved to be quite accurate. Taking the number of amendments to the work programme as an indicator we can see a clear reduction of amendments from the second to the third Health Programme; in the second Health Programme, three out of six annual work programmes needed amendment indicating that the planning was not so effective or lacked flexibility. Until now the third Health Programme needed to be amended in 2015 under specific circumstances for helping Member States to cope with the refugees’ crisis. The coherence between the Multi-Annual Planning and the Programme implementation is a measure of its effectiveness as it illustrates that the Multi-Annual Planning not only facilitated the drafting of the Annual Work Programmes but that it was realistic and accurate; its objective was not to set plans in stone but rather a plan which will be flexible to new/unexpected developments (refugees crisis) or to changing timetables (delay in the adoption of legislation for medical devices). Moreover, the main focus for years 2014, 2015 and 2016, respectively on prevention of chronic diseases, health technology and innovation and establishing European reference Networks, has been confirmed and acknowledged by the mid-term evaluation. The independent study found that the introduction of the Multi-annual Planning has improved the ability to purposely focus spending on key areas as reflected in the data provided in detail under efficiency (EQ9). EQ7:How effective is the introduction of ‘exceptional utility’ criteria in the Regulation establishing the 3HP (paragraph 19) in order to incentivise the participation of low GNI Member States? The exceptional utility criterion has not been so far effective in incentivising the involvement of low GNI Member States and helping them to be more actively involved and absorb bigger parts of the Programme budget. The exceptional utility criterion addresses a significant problem for low GNI countries to participate in the Programme. While exceptional utility was also used in the previous Health Programme, the ‘exceptionally utility’ criterion was enshrined for first time in the Programme Regulation (EU) N° 282/2014 covering only Joint Actions. The rationale behind was to incentivise low GNI countries and keep them participating in the Health Programme especially under the difficult economic circumstances of the financial crisis started after 2009-2010. From the beginning of the Programme implementation in 2014, the criterion has been slightly adapted and has been extended to cover also grants for projects and operating grants. The new criteria (for their definition see Annex III) were providing for a greater number of countries to be considered for applying higher co-funding rate (up to 80 % for EC contribution). Table 6: MS triggering higher co-funding in 2HP and 3HP BG CY CZ EE ES EL HR HU LT LV MT PL PT RO SI SK TOTAL 2HP 7 3HP 16 However, there is no evidence that participation of low GNI countries is incentivised by the simplified, extended and expanded exceptional utility criteria. On the contrary contractors found examples where both joint actions and projects were fulfilling the criteria but they have not applied for ‘exceptional utility’ funding of up to 80 %. In the first three years of Programme implementation the part of funds awarded to high and low GNI countries seem to show a rather retro-gradation (see the below table) implying that either the criteria are not clearly understood by the applicants, or that other unknown factors may intervene.

Table 7: Balance of funds to joint action beneficiaries from low and high GNI countries Low GNI High GNI 2HP 29% 71% 3HP 25% 75% Source: CHAFEA For projects the situation is also quite similar with no difference between the second and third Heath Programmes. Table 8: Balance of funds to projects beneficiaries in low GNI and high GNI countries Low GNI High GNI 2HP 28% 72% 3HP 26% 74% Source: CHAFEA The instrument has a low up-take so far and functions less for projects and joint actions in comparison to the operating grants (14 out of 41 of them received exceptional utility). Possible reasons for this low take-up are limited awareness or understanding of the criteria or that the criteria are insufficiently addressing the needs of the GNI countries and so less attractive to overcome other challenges. Indeed, securing co-funding is very important for low GNI countries (11 respondent to the e-survey with National Focal Point and Programme Committee members corresponding to 44% of the total selected and from those eleven, seven are from low GNI countries) but is not the only barrier of participation. Administrative burden is also mentioned as quite prohibitive by respondents from high GNI countries while irrespectively of the relative income of a given Member State, lacking skills and institutional resourcing challenges were also cited. EQ8:In practice, to what extent are the actions in the AWP contributing to the 3HP objectives and thematic priorities and to the Commission policy priorities? The Health Programme is being implemented focusing on major Commission priorities, such as: (a) jobs, growth and investment (health of population and health care services as a productive factor for growth and jobs), (b) internal market (for tobacco, pharmaceuticals, medical devices, cross-border health care directive, and Health Technology Assessment), (c) digital single market (including eHealth), (d) justice and fundamental rights (fighting against health inequalities), (e) migration policy, and (f) security (preparedness and management of serious cross-border health threats). From the evidence provided by the case studies (29 actions corresponding to 8 thematic priorities), contractors showcase key examples of meaningful achievement: Diagnostic microbiology provides crucial results for the clinical management of infectious disease patients, but also for the identification of a given pathogen for public health surveillance, outbreak alert and response. The Commission supports Member States' cooperation on laboratories under the EU Health programme to strengthen preparedness and response to serious cross-border threats to health. The funded laboratory networks addressed preparedness activities aiming at continuous quality improvement in the rapid diagnosis, surveillance, epidemic intelligence and public health risk assessment for infectious diseases as well as risk management activities through rapid identification and characterization of infectious agents which may threaten public health. The establishment of 24 European Reference Networks is also a key achievement for the development of better and safer healthcare, after years of previous work on rare diseases, and facilitating the implementation of Directive 2011/24/EU on patients’ rights in cross-border healthcare (see point 2.2.4 above). Moreover, the Programme's major contribution to innovative, efficient and sustainable health systems are the approaches to the implementation of Health Technology Assessment (a subject on which the Programme works since 2002-2007). Now under the third Health Programme, the biggest Joint Action to date with EUR 12 million aims to anchor these in Member States practices. As already described under point 2.2.3, the cooperation is currently based on a voluntary mechanism supported by Article 15 of Directive 2011/24/EU which provides that the EU cooperation on Health Technology Assessment can receive EU aid. Although successful, there are also identified shortcomings in the current cooperation arrangement. The Commission is currently finalising an Impact Assessment assessing different options how to strengthen cooperation thus building on the achievements of the Joint Actions, address their shortcomings, and ensure sustainability of the cooperation beyond 2020 when the current Joint Action ends. In parallel, the Health Programme supports wider Commission priorities such as the Digital Single Market by assisting Member states in including eHealth into health policies while better aligning eHealth investments to health needs. Mechanisms such as the Expert Panel on Health and the Expert Group on Health Systems Performance Assessment produced opinions and advice for the benefit of Member States in the context of the health systems’ reforms.

The support to legislation on medicinal products and medical devices guarantees the free movement of these products in the internal market, the safety of Europeans and is also related to the good performance of health systems. The actions funded concern the development and maintenance of databases e.g. the European Database for Medical devices (EUDAMED), which gives relevant agencies in Member States access to information on medical devices available on the market and the list of economic operators; management of marketing authorisations for medicinal products and of maximum residue limits of veterinary medicinal products practices (e.g. European Medicinal Products database);, the issuing of guidelines for harmonised practices, inspector training programmes implemented for medical devices, studies for informing the relevant regulatory frameworks for medicinal products and medical devices. The Health Programme has supported the identification, dissemination and takes up of best practices in risk factors and chronic diseases (for more information please refer to above point 2.2.1). The Programme supports also the collection of indicators and data for the State of Health in Europe and the European Core Health Indicators. The nature of contribution is different from one action to another and among the different objectives they serve. For instance while objectives 2 (health threats) and 4(better and safer health) have appeared likelier to generate concrete benefits in the near future, related to the existence of EU legislation and consequently much better focused actions with undisputable EU-added value, objectives 1(promotion of health) and 3(innovation in health systems) address bigger health needs in Member States and their EU-added value depends on identifying gaps in the sharing/uptake of best practices. Actions, especially under objectives 1 and 3, are in need of improved intervention logic and credible plans for follow-up. There are also some common challenges for generating sustainable impacts, for instance by ensuring that activities are anchored in the Member States and local contexts, that there is ownership of and input in the results. Also accessibility of the programme to all Member States and other participating countries (see question on exceptional utility) and new players is another important aspect for the success of the Programme objectives. 5.3 Efficiency EQ9:To what extent does the design of the 3HP lead to an efficient allocation of resources among objectives / thematic priorities? The Programme Regulation (EU) 282/2014 does not include an obligation for spending precise amounts of the EU budget on the four specific objectives and the 23 thematic priorities. On the contrary the legislation provides for enough flexibility and paragraph (5) states that: ‘The emphasis should be placed, in accordance with the principle of subsidiarity, on areas where there are clear cross-border or internal market issues at stake, or where there are significant advantages and efficiency gains from collaboration at Union level’. This said, the Programme has to cover the maximum of the 23 thematic priorities still valid (as concluded by the independent evaluation study) while prioritising and focusing more on some of them. The table below shows that more than 73% of the overall Programme budget in 2014-2016 was used to focus on a series of major priorities throughout the four specific Programme objectives. Another 23 % has been attributed to actions that are of high EU-added value but on which important synergies exist: it needs to be noted that other funding programmes/actions cover similar objectives. For example health threats are addressed by the European Centre for Disease Control, which has an annual budget of nearly EUR 60 million dedicated to fighting communicable diseases, and by DG RTD with research funding on rare diseases and antimicrobial resistance. A very small part of the Programme (approximately 4 %) has been used for supporting action in areas such as the health workforce, the prevention and information on drugs related health damage and the expert panel on health. eHealth is an exception under this category and funds for this priority will be increased in the second half of the Health Programme (see below under EQ 16) as the interest in this area increases with the Digital Single Market Strategy. The Health Programme will work more intensively in the coming years to help policy-makers to better understand the digital revolution that is taking place across societies and bring this broader perspective to the specific work on digitalisation in health making sure that Europeans can benefit from the new era of digitalisation in managing their own health. Table 9: Budget allocation throughout the thematic priorities

As a consequence, the budget allocation in the first three years of the Programme implementation is in comparison to the past Programme, more strategic and balanced among the different specific objectives as the table below shows: Although the design of the third Health Programme is different from the second, the above observation is quite clear as depicted in the following figures. Objective 1(health promotion) has seen its budget decreased, the new objective 3 (innovation in health systems) receives a similar proportion of budget as objective 1, and objectives 2(health threats) and 4(better and safer health) which with the exception of ERNs and rare diseases cover what in the previous Programme was called ‘health security’ have received together with the priority ‘HIV/AIDS, tuberculosis and hepatitis’ (currently under objective 1) slightly more credits than before. EQ10:To what extent does the allocation of resources allow for an efficient implementation of the 3HP in terms of: funding mechanisms, simplification measures and operational costs? The implementation of the first three years of the Programme confirms trends appeared already at the end of the second Health Programme. The part of the budget dedicated to Joint Actions and procurement contracts continue to be increased in comparison to grants for projects. Moreover, the average budget per action increases also and this is a good indication that the Programme becomes more focused as the consequence is to limit the number of actions. Ultimately the aim is to gain in efficiency. Table 10: Average budget of financial mechanisms, 2HP and 3HP for the submission and evaluation of proposals the management of grants and e-reporting and monitoring Financial mechanism Average budget per action 2HP 3HP Joint action €2.1 m €3 m Project €0.7 m €1.3 m Operating grant €0.2 m €0.3 m Direct grant agreement €0.4 m €0.3 m Service contracts – CHAFEA €0.2 m €0.4 m Service contracts – DG SANTE €0.2 m €0.07 m Conferences €0.07 m €0.07 m Also the costs needed to administer the third Health Programme, provided for an overall of EUR 10.5 million as administrative support credits and another EUR 29.2 million for the functioning of the Executive Agency, for 2014-2020, suggests that the percentage of the total budget proportion dedicated to operational costs is 9 %. Benchmarking with other programmes of similar size (consumer programme) and with much higher budget (Horizon 2020) demonstrated its efficient execution. Table 11: Budgetary data for 3HP, Consumer Programme and Horizon 2020 (2014 – 2020) Programme Administrative support budget Executive Agency budget Total budget Proportion of total budget to administrative support and executive agency Health Programme €10.5 m €29.2m €449.4 m 9 % Consumer Programme €7.5 m €10.9 m €188.8 m 10 % Horizon 2020 €3 594.6 m €946.2 m €74 320.4 m 6 % Moreover, some simplifications already in the design of the Programme such as harmonisation of co-funding rates to 60% (or in case of exceptional utility to 80%), the use of framework contracts on a three years period for the operating grants, simplifications to requirements for amendment procedures, most importantly the ability for beneficiaries to transfer resources between different cost categories without the need for an amendment, the introduction of the Multi-annually planning all these converge into a smoother and less complex Programme implementation. Despite the fact that electronic tools have been introduced with the third Health Programme in 2014 for the submission and evaluation of proposals, the management of grants and e-reporting and monitoring, and Programme beneficiaries are satisfied with the online migration of action-level monitoring (it has reduced the administrative burden for both CHAFEA and beneficiaries while making it easier to monitor progress in real time), the administrative burden mentioned by stakeholders as one of the key barriers for participation in the Health Programme (especially from Member States representatives from high GNI countries) and confirmed again through the open public consultation, implies that there is still room for improvement in the efficiency. However, the contractors recognize that actions require significant investment from all stakeholders for being well prepared and that more importantly and irrespectively of the size of an action, the biggest driver for efficiency is how effective the action is in achieving its goals and therefore the value added.

EQ11:How may the efficiency of the 3HP be improved regarding number of priorities; funding mechanisms; application and implementation procedures and available resources? Increasing the effectiveness and impact of a Programme also increases its efficiency. That is why it is important to keep the Programme focused on a limited number of outcome-oriented actions relevant to Member States needs and aligned to the major Commission priorities. Although no specific recommendation was made, the independent evaluation study did suggest revising the mission of operating grants to non-governmental organisations and making the link with the specific Programme objectives more explicit. Additionally, choosing the most appropriate financial mechanisms (see table 7 above) and publishing clear descriptions of the expected outputs in the Annual Work Programme, after having made a good estimation of the necessary budget for the actions, gives stakeholders and other economic actors everything they need to prepare good proposals and/or offers and facilitates effective administrative management for the selection and award of actions to be funded (e.g. avoiding the re-launch of calls for proposals and calls for tenders and making the best use of CHAFEA resources). Moreover, simplification measures that have been already taken by CHAFEA (e.g. introduction of electronic tools for the e-submission of proposals, e-managing grants and tenders and e-reporting) are expected to yield positive results and in the next years make for more efficient use of CHAFEA resources to improve the monitoring, reporting and dissemination of Programme results, which will also have a positive impact on the Programme’s efficiency. EQ12:To what extent are the monitoring processes and resources (at the Commission and MS level) sufficient and adequate to plan and promote the results of the Health Programme? Following up from the findings on the second Health Programme, substantial efforts have been made to improve the monitoring of the third Health Programme. Indicators at the level of objectives have been introduced. For Objective 1 (promotion of health and diseases prevention) : Number of Member States involved in health promotion and diseases prevention, using evidence-based and good practices through measures and actions taken at appropriate level in the Member Sates oNumber of Member States with national initiative for the reduction of saturated fat; oNumber of Member States in which the European accreditation scheme for breast cancer services is implemented –establishment of the scheme. For Objective 2 (health threats): Number of Member States integrating coherent approaches in the design of their preparedness plans; For Objective 3 (health systems): Advice produced (in particular the number of HTA produced per year) and the number of Member States using the tools and mechanisms identified in order to contribute to effective results in their health systems (patient summaries data/ePrescriptions in line with EU guidelines) For Objective 4 (better and safer health): Number of ERNs established in line with Directive 2011/24/EU; number of health care providers and centres of expertise joining ERN; number of Member States using the tools developed. These indicators are still far from being comprehensive. In some cases they are much narrower and more focused than the priorities outlined in the Annex I of the Programme Regulation. For objective 4, the indicator is related only to ERNs which are certainly a big part (EUR 12.6 million) of the overall budget devoted to this objective (EUR 30.6 million). The diversity of actions funded makes it difficult to design and implement standardised indicators (at objective and/or at priority level) beyond the delivery of concrete actions. For this reason and in addition to the above indicators at Programme level, a set of more specific indicators have been defined and, through the use of e-management tools allowing for electronic monitoring at action level, have been introduced as e-questionnaires for all grants (operating grants, grants to projects, joint actions and direct grants). The idea is to gather information on type of beneficiary, deliverables and the concerned and targeted population as well as dissemination strategy deployed and dissemination activities implemented as part of the action. These indicators common to all actions (with the exception of operating grants) could facilitate aggregation and later assessment of EU-added value. For operating grants the indicators also include a particular set of indicators on support given on the development of health policies to the Commission, support to patients’ empowerment and increase of health literacy. Unfortunately, due to time constraints the study found little evidence of how the specific indicators for projects, joint actions and direct grants have been used, and therefore was not possible to analyse the information and assess its accuracy for reporting purposes. The e-questionnaires were sent to beneficiaries in late 2016, while the ones for operating grants should have been available for the evaluation since it has been in place for a while. The problems with the monitoring of the Health Programme are well known also from evaluations of previous Programmes. In those cases, the main reason was the complete absence of monitoring indicators. The mid-term evaluation revealed that despite the substantial efforts for the definition of indicators, significant shortcomings continue to be unaddressed. Information is not stored or organised in an efficient manner so that data are ready to be analysed. The fact that a part of the Programme is managed by CHAFEA and another smaller part by DG SANTE makes it difficult, in the absence of a well-design monitoring tool, to have rapidly the complete and correct picture of how the budget is spent and for which kind of outputs. Linking up data manually with thematic priorities and collate and cross-check the information, as we have done for the outsourced evaluation, is a very resource intensive exercise and prone to error. It seems that the monitoring is used only for financial accountability purposes, but this is only a part of what has to be the monitoring of a Programme. With a good monitoring tool, the information gathered on actions and their state of implementation including information on progress indicators could be used to better publicise the activity of the Health Programme. By making results of actions and other information publicly available and trying to ensure that the results reach the right kinds of stakeholders, this can facilitate their take-up beyond those who are directly involved in the actions.

The creation of a new project database has been repeatedly postponed by CHAFEA and the existing one has not been updated with the new Programme actions neither improved at the moment this document was being drafted. The project database currently only contains all actions for year 2014, but no information for Joint Actions 2015, and no information about awarded actions in 2016. Moreover, none of the procurement contracts and direct grants are covered by this database, for all previous Programmes and for the current one. Positive developments are noted on publication and dissemination actions. Info sheets on 12 health topics and in all 23 EU languages have been published on the CHAFEA Website. CHAFEA together with the National Focal Points have run a variety of well-attended events: 16 events have been organised in 2015-2016, and another 11 that are planned or already implemented in 2017. The report CHAFEA made on these dissemination activities has noted the high-level of satisfaction and success of these events organised mainly in Member States and financed under the third Health Programme. CHAFEA has developed in cooperation with DG SANTE the dissemination strategy, this also recommended in the ex-post evaluation of the second Health Programme. The study notes ̶the increasing prioritisation and professionalism awarded to dissemination’ and mention also the Health Policy Platform launched in 2016 by DG SANTE and the use made of it to disseminate information among relevant stakeholders for instance training packages for health professionals and frontline staff working with refugees and other migrants. 5.4 EU-added value EQ13:To what extent are the seven EU added value criteria addressed in proposals? The EU-added value is defined in the third Health Programme and enshrined in the Programme Regulation (EU) 282/2014 in paragraph (6): ‘The Programme should be a means of promoting actions in areas where there is a Union added value that can be demonstrated on the basis of the following: exchanging good practices between Member States; supporting networks for knowledge sharing or mutual learning; addressing cross-border threats to reduce their risks and mitigate their consequences; addressing certain issues relating to the internal market where the Union has substantial legitimacy to ensure high-quality solutions across Member States; unlocking the potential of innovation in health; actions that could lead to a system for benchmarking to allow informed decision-making at Union level; improving efficiency by avoiding a waste of resources due to duplication and optimising the use of financial resources.’ The above with the exception of issues related to the internal market and the potential of innovation in health, come from the criteria the Executive Agency has defined and which were used in the second Health Programme. With the third Health Programme these criteria became a clear while not distinctive part of the evaluation criterion ‘contribution to public health in Europe’ for Joint Actions and ‘policy and contextual relevance’ for projects and operating grants. The procurement contracts are not assessed for their EU-added value as this is part of the decision process for launching the procurement procedure and defined in the terms of reference. The case studies investigating the application of the EU-added value criterion showed that the process for assessing EU-added value is improving and becoming more systematic. Building the EU-added value criteria into the application process for funding has been a major improvement: most of the potential beneficiaries consider EU-added value when preparing their proposals, and the assessment panels in turn take it into account as part of the decision to award funding. The short time elapsed since the action plan agreed on recommendations of the ex-post evaluation of the second Health Programme in March 2016, was the main reason for specific recommendations on EU-added value to not being fully implemented by CHAFEA and DG SANTE. This is about the redefinition of three EU-added value criteria related to the exchange of best practice, networking and benchmarking for better decision-making. The recommendation was to make them more detailed, concrete and outcome focused (e.g. plausible plans to see best practices actually implemented than only shared). For best practices the discussion has already started in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases, established in November 2016.(see above point 2.2.1). The study showed that there is still scope for being more systematic in the assessment of the EU-added value criteria and to make it clearer for applicants through concrete examples what the EU-added value is and how it feeds into the award process. 5.5 Coherence EQ14:To what extent have the thematic priorities of the 3HP led to more synergy, focus and coherence between the funded actions in delivering on the objectives? Compared to the previous Health Programme, the structure of the third Health Programme has been revised with improved specific objectives providing more clarity and focus, and further elements for operationalisation have been introduced which was not the case in the previous Programmes. Instead of longer priorities and sub-priorities often repeated under different objectives, now the third Health Programme has consolidated, concrete thematic priorities unique under each of the four specific objectives. In almost all cases actions now fall under one thematic priority, even if synergies with other priorities are possible, the increased purposiveness and topical focus of the thematic priorities enables greater clarity and coherence in the scope of actions. In some cases, it was possible to organise a sizeable action (e.g. ‘Best practices in care provision for vulnerable migrants and refugees’ in Annual Work Programme 2016) targeting on purpose two thematic priorities simultaneously (priority 1.3 on HIV/AIDS, tuberculosis and hepatitis, and priority 1.4 relating to chronic diseases. There is consensus from all interviewees, public health experts in focus groups, case studies and respondents to the open public consultation that the new structure of the Programme is a success enabling more concretely defined areas of intervention. Moreover, synergies exist between the actions under the same or different thematic priorities. The structure of the Programme certainly enables such cross-cutting work, but most importantly this is the result of successful exploitation of relations between the different actors/beneficiaries as well as good programme management and communication with stakeholders. For instance the European Cancer League (ECL) which is funded through an operating grant under thematic priority 1.4 for chronic diseases has a memorandum of understanding with the Smoke Free Partnership which receives also an operating grant from the third Health Programme under priority 1.4 on risk factors, creating a framework for joint work and the sharing of perspectives. The ECL is also an associated partner in the CANCON joint Action (funded under the second Health Programme) and provided inputs on survivorship and rehabilitation throughout 2016. ECL uses the CANCON newsletter to promote the European Code Against Cancer one of its key activities funder by the operating grant. Other examples illustrate how the third Health Programme builds on the success of previous work undertaken in the previous Programme. For instance the Joint Action EMERGE launched in 2014 is the result of merging of two networks of highly pathogenic agents, funded in 2010 as the QUANDHIP Joint Action. In some other cases, the sequencing of different actions (e.g. the Joint Action on rare diseases (RD-Action) which built on the work of the previous joint action in the second Health Programme and supports the adoption of a codification and knowledge management system for rare diseases, which will be necessary for ERNs to diagnose patients and share knowledge and expertise across the EU , together with the Study on the Manual and Toolbox for Assessing ERNs whose objective is to develop an assessment manual that will serve as an evaluation framework for ERNs, all that together prepares and contribute to the creation , implementation and operation of ERNs (see point 2.2.4). However, there is still risk in areas where the third Health Programme has ambitious goals and the scope is broad (e.g. chronic diseases) to see actions fail either because they do not relate closely to other ones (different actions in different areas such as mental health, dementia, cancer) or simply because they cannot make the most of potential links.

EQ15:To what extent are the objectives and thematic priorities of the 3HP externally consistent/coherent i.e. is there correspondence between: the 3HP and health objectives of Article 168 TFEU, and those of other public interventions (e.g. national health policies, EU policies and Programmes, other international actions)? The Health Programme is linked to the high-level priorities of Europe 2020 Strategy and since 2015 is oriented towards the Commission 10 priorities (known as "Juncker priorities") and DG SANTE strategic objectives. It emphasises the links between economic growth and a healthy population, to a greater extent than previous programmes, concentrates on health systems as a productive factor for growth and jobs, contributes to smooth functioning of the internal market by supporting EU legislation on tobacco, medicinal products and medical devices, cross-border health care directive, and Health Technology Assessment, as well as to the digital single market with actions related to eHealth ; the Programme has demonstrated its ability to undertake rapidly appropriate actions for migrants and refugees as migration is also an important issue, and fights against health inequalities for the respect of justice and fundamental rights. Last but not least, its actions on preparedness and management of serious cross-border health threats for a coordinated response to highly dangerous outbreaks (e.g. Ebola and Zika) ensure the protection of EU population's health and security. In almost all the above mentioned areas the Work Programme works closely with other EU Policies and Programmes such as Horizon 2020 (e.g. on Health Technology Assessment, anti-microbial resistance etc.), migration policy, chronic diseases and reduced ability to work, taking into account the principle of ‘health in all policies’. Other financial mechanisms such as the European Social Fund (ESF) and the European Regional Development Fund (ERDF) from the EU Structural and Investment Funds (ESIF) could also be better used to scale-up actions and results of the Health Programme as objectives and thematic priorities are coherent with these instruments. While the Programme informs about these possibilities and promotes ESIF, evaluators have not found evidence that this happens practically probably due to the early stage of the third Health Programme’s implementation. At international level, through EuropeAid the EU supports global health initiatives such as the Global Fund to fight HIV/AIDS, Tuberculosis and Malaria, and GAVI, the Global Alliance for Immunizations. The Commission has been a founding member of the Global Fund and has contributed more than EUR 1.6 billion, which corresponds to about 6 % of the USD 30 billion that the Fund has committed to 140 countries so far. As a result, 10 million people are on anti-retroviral therapy for AIDS, 16.6 million people have been tested and treated for tuberculosis, and 713 million insecticide-treated nets have been distributed to protect families against malaria. Commissioner Mimica pledged in September 2016 a further EUR 475 million to the Global Fund for the period 2017-2019, which is an increase of EUR 105 million (or 28 %) to the current contribution. GAVI has supported the full vaccination of 277 million children in 2010-2015, with the goal of a further 300 million fully vaccinated children in the period 2016-2020. These global initiatives complement thematic priority 1.3 on HIV/AIDS. Tuberculosis and hepatitis and objective 2 on health threats of the Programme and under this objective close cooperation is developed with WHO and G7 within the Global Health Security Initiative for the creation of an effective and well-organised global strategy for preparedness and responses to potential health threats. The EU through its development instruments also supports initiatives to provide technical assistance to regional capacities in order to build preparedness and response, such as the West African Regional Centre for Disease Surveillance and Control, and working with the WHO to build robust national animal health and veterinary public health surveillance systems. EU support to the WHO has also made it possible to tackle the growing threat of antimicrobial resistance with a first survey on availability and prices of antibiotics being carried out in the sub-Saharan region. Also through the third Health Programme the EU makes an annual contribution to the WHO’s European Observatory on Health Systems and Policies, and the Framework Convention on Tobacco Control (FCTC) in which the EU is part, complements the Programme’s priorities 1.1 on risk factors (tobacco use) and 1.5 on tobacco legislation. Furthermore EuropeAid provides support to strengthen the capacity of developing countries that are parties to the WHO FCTC so that they can meet their obligations under the Convention. However, the Programme remains quite invisible as an international policy instrument and this is expected as it concentrates by definition on capacity building within the EU and the other participating countries. From 2016 onwards, Serbia and Moldova participate in the third Health Programme and Bosnia and Herzegovina from 2017 onwards, while other Western Balkan countries have expressed also interest. This may be interpreted as the increasing importance of the health Programme objectives and priorities for these countries. Moreover, the Programme has a great potential in dealing with issues that come up on the international agenda such anti-microbial resistance and the impacts of the climate change on health and environment. 5.6 Utility EQ16:To which extent is the 3HP overall useful and, if necessary, how could its overall utility be increased? What are the specific needs of Member States to which the Programme could provide a concrete solution but has not done so yet? The Health Programme is our unique financial instrument to support policy coordination with Member States and key health stakeholders (including health professionals), and to make progress on the agreed Programme objectives and strategic targets linked to the Commission priorities. The Programme is well positioned to serve Member States in areas where EU-added value can be generated: -under the Commission priority on ‘growth, jobs and a resilient society’, the Programme is promoting the health of the population and health care services as a productive factor for growth and jobs, -on the ‘digital single market’, the Programme promotes eHealth and helps Member States to invest in new technologies, -on the ‘internal market’, the Programme finances actions supporting EU legislation on tobacco, pharmaceuticals, medical devices, the cross-border health care directive, and Health Technology Assessment, -on‘justice and fundamental rights’, the Programme helps to eradicate health inequalities, and -makes a significant contribution to the ‘migration’ policy through actions on migrants and refugees; -on ‘security in Europe’ the Programmes increases the capacity of Member States to prepare for and manage serious cross-border health threats.

Moreover, the Programme covers the development and implementation of EU health legislation (on tobacco, cross-border health threats, medicinal products, medical devices, cross-border healthcare and substances of human origin) and provides support for policy coordination and the development of health information infrastructure. The programme facilitates networking among the public health community in Europe and with international initiatives, promotes best practices and helps Member States to reach their sustainable development goals, in particular SDG 3 ‘Ensure healthy lives and promote wellbeing for all at all ages’ . In the coming years the Programme will prioritise the following areas while addressing health inequalities in a cross-cutting manner. : -country specific and cross country knowledge (addressing all objectives of the programme) -structural support to health systems and link to digital single market -cross-border health threats, preparedness and response, including antimicrobial resistance; and -promotion of health and prevention of non-communicable diseases. The utility of the Programme increases with the use of the Programme outcomes and the integration of best practices into the national health policies. The Programme works as a tool for policy coordination, for the collection and analysis of harmonised and comparable health data and as an incubator of good practices and pilot projects. The Programme outputs are mainly addressed to policy makers and health professionals who are expected to make use of them on a large scale (e.g. colorectal cancer screening). This will be a real test for the Programme's usefulness. By undertaking the challenge to create synergies with other bigger EU financial instruments such as the European Structural Funds and the Structural Reform Support Service for the up-scale of its actions, the Programme can take a decisive step that maximises its impact on the health of Europeans and boosts the sustainability of the health systems in the EU. 5.CONCLUSION The third Health Programme is highly relevant to Member States health needs and the objectives set are clear, explicit and specific. The 23 thematic priorities are still valid and help the Programme to better focus on outcome oriented actions. In the longer term, contractors recommended to consider further streamlining some thematic priorities to avoid any potential overlap or ambiguities. All of these are indeed relevant to real needs in Member States and are in line with high-level Commission priorities and existing challenges. The Programme demonstrates significant progress in a number of areas building on previous work and the first signals of its effectiveness are the establishment of 24 European Reference Networks for rare diseases, the adoption of common methodologies for Health Technology Assessment , the delivery of tools and piloting of joint assessments, the support to Member States for increasing their capacity building and respond to outbreaks, the continuing updating of skills for health professionals and other front line staff working on emergent issues such as the refugees crisis. Moreover, the Health Programme supports implementation of EU health legislation in a series of areas such as tobacco, medicinal products, medical devices, cross-border healthcare, etc., closely related to the priority of safe and well-functioning internal market. The Programme demonstrated its responsiveness and flexibility to take into consideration emerging needs such as the influx of refugees in 2015-2016. From 2017 onwards, The Programme supports also the Solidarity Corps. The Programme management has become increasingly effective. The Multi-annual planning has enabled a more strategic approach to medium term planning. The process for the adoption of Annual Work Programmes is clear, well-defined and impartial while it seems to be not so well known by stakeholders and has to be better explained in order to ensure its buy-in and avoid misunderstandings. The Programme management has been improved in comparison to the past with introduction of indicators, and simplified with the use of electronic tools for submission of proposals and management of grants, but also simplified rules and procedures. There is still need for improvement in better monitoring and reporting on actions, while the dissemination, although improved, needs to be prioritised (new Project database and operationalization of the newly established Dissemination strategy). Otherwise, the Programme suffers from low visibility and risks to lack credible elements demonstrating its progress and utility. By and large the allocation of resources is efficient and the operational costs for its execution remain at acceptable level. By increasing its effectiveness, the Programme can also increase its efficiency.

The Programme attracts participation of all EU Member States and EFTA countries (Norway and Iceland) and three new countries from the Balkan Peninsula (Serbia, Moldova, and Bosnia and Herzegovina) joined it recently. Financial incentives are proposed through exceptional utility criteria for boosting participation from low GNI countries and the increased co-funding rate of 80% applies to all the participants in an action. Evidence from the first three years of Programme implementation shows that these opportunities have not been sufficiently used and low GNI Member States mentioned in the e-survey and in the open public consultation that assuring co-funding is one of the most important barriers for participation in the Health Programme. The Programme has increased its ability to target important health needs where it can add value. By anchoring the seven EU-added value criteria into the Programme Regulation and making them part of the decision-making process for awarding funding, the applicants are informed well in advance and consider the EU added value when they are preparing their proposals. This is conducive to better designed and explained proposals for the consideration of the assessment panels and so, the actions awarded for funding can operate in a way that adds value at EU level. The study showed that there is still scope for being more systematic in the assessment of the EU added value criteria and to make it clearer for applicants through concrete examples what the EU added value is and how it feeds into the award process. Objectives for responding to cross-border health threats and giving access to better and safer health seem to produce outcomes with undisputable high EU-added value. The Health Programme is coherent with major Commission priorities and policies, and with Sustainable Development Goals. To achieve outcomes and results that addresses the existing challenges in a comprehensive manner, the Health Programme operates in synergies, either among its own priorities and their corresponding actions (internal coherence) but also with other DGs (external coherence) on the basis of the principle of ‘health in all policies’ and with specific EU Programmes such as the Horizon 2020 and/or with its predecessor the 7th Framework Programme. Possibilities to increase synergies and ensure the up-scale of successful Programme actions and results exist through other financial instruments, such as the EU Structural and Investment Funds and should be used.



ANNEX I: PROGRAMME DESCRIPTION A. Thematic priorities 1. Promote health, prevent diseases and foster supportive environments for healthy lifestyles 1.1. Risk factors such as use of tobacco and passive smoking, harmful use of alcohol, unhealthy dietary habits and physical inactivity 1.2. Drugs-related health damage, including information and prevention 1.3. HIV/AIDS, tuberculosis and hepatitis 1.4. Chronic diseases including cancer, age-related diseases and neurodegenerative diseases 1.5. Tobacco legislation 1.6. Health information and knowledge system to contribute to evidence-based decision-making 2. Protect Union citizens from serious cross-border health threats 2.1; Additional capacities of scientific expertise for risk assessment 2.2. Capacity-building against health threats in Member States, including, where appropriate, cooperation with neighbouring countries 2. 3. Implementation of Union legislation on communicable diseases and other health threats, including those caused by biological and chemical incidents, environment and climate change 2. 4. Health information and knowledge system to contribute to evidence-based decision-making

3. Contribute to innovative, efficient and sustainable health systems 3.1 Health Technology Assessment 3.2. Innovation and e-health 3.3. Health workforce forecasting and planning 3.4. Setting up a mechanism for pooling expertise at Union level 3.5. European Innovation Partnership on Active and Healthy Ageing 3.6. Implementation of Union legislation in the field of medical devices, medicinal products and cross-border healthcare 3.7. Health information and knowledge system including support to the Scientific Committees set up in accordance with Commission Decision 2008/721/EC 4. Facilitate access to better and safer healthcare for Union citizens 4.1. European Reference Networks 4.2. Rare diseases 4.3. Patient safety and quality of healthcare 4.4. Measures to prevent antimicrobial resistance and control healthcare-associated infections 4.5. Implementation of Union legislation in the fields of tissues and cells, blood, organs 4.6. Health information and knowledge system to contribute to evidence-based decision-making B. Further explanations on what results are being achieved and which are the impacts expected from the Programme? Objective 1: Promote health, prevent diseases and foster supportive environments for healthy lifestyles

The third Health Programme action is helping to collect evidence and data on e.g. alcohol consumption and alcohol policies in all Member States, as well as national policies related to nutrition, physical inactivity, and overweight and obesity related diseases. To help Member States develop better and more coordinated policies, an online reference guide as one-stop clearing house for independent, reliable and up-to date information on a wealth of topics related to nutrition, physical activity and prevention of chronic conditions is being developed by the Commission’s Joint Research Centre financed by the third Health Programme. The guide is written for policy-makers in EU Member States and provides concise information that can be quickly used to answer their questions and translate to their policy work, while it is also open to the other professionals in the relevant fields as well as to the general public. Tobacco use, unhealthy diet, physical inactivity and alcohol consumption are the main risk factors responsible for the biggest part of chronic diseases that affect the capability to work, are costly to treat and ultimately impact economic performance. Chronic diseases account for more than 80 % of the disease burden of the EU and are thus a major cause for high health expenditures. Through the third Health Programme the European Union joins its forces with the 28 Member States to combat chronic diseases and promote active & healthy ageing. To do so, based on previous work undertaken identifying good practices, e.g. in the area of health promotion or defining better care models for multi-morbid patients, the third Health Programme focuses on supporting Member States to make decisive step towards implementing good practices: what has functioned well in other Member States should be piloted elsewhere or up-scaled internally. To strategically enhance the transfer of best practices DG SANTE established a Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases in November 2016 . The Health Programme has developed the EU-Compass for Action on mental health and wellbeing which is a web-based mechanism used to collect exchange of best practices and analyse information on policy and stakeholder activities in mental health. The Compass is piloting the common criteria on best practices selected at EU level and approved by the Steering group on Promotion and Prevention, and the results will be presented in October 2017. On dementia, and in particular post-diagnostic support, crisis and care coordination, quality of residential care and dementia friendly communities, best practices already selected are being piloting under second Joint Action with Member States competent authorities. On cancer, the European Quality Assurance scheme is being developed in harmonised, evidence-based and flexible way to grant equal and quality-benchmarked treatment to patients. The mid-term evaluation of the breast cancer initiative show that all the activities planned toward the official launch of the European Quality Assurance scheme planned for its final release in 2019 is on-track with the publication of European Breast Guidelines currently ongoing and with the timeline for the launching of the Guideline platform, the digital breast screening training template and the piloting of the European Quality Assurance scheme in 2018. So far 10 recommendations have been published and are currently available for consultation by patients, health care workers and policy makers through the Joint Research Centre (JRC) interactive IT tool. A further publication of 20 recommendations has been forecasted before the end of 2017. On the implementation of breast centres in the Member States the Commission receives the official information that although breast units are required by law in few countries. They are recommended and implemented in 17 Member States. The activities of the European Network of Cancer Registries coordinated by the JRC delivers important results providing a ‘data-brokering’ service to ensure integrity of a single European dataset for different purposes. 128 Cancer Registries from 29 European countries are regularly providing data to JRC with more than 25 900 000 records so far in the database. The CANCON joint action from the previous second Health Programme reached the end in March 2017 delivering the European Guide on Quality Improvement in Comprehensive Cancer Control and five policy papers. The Guide has been adopted by the Expert Group on Cancer Control and it will be the base for the further upgrade of the National Cancer Plans and their implementation during the oncoming years. Finally the Health Programme supports the involvement of civil society in a continuous dialogue with the EU on health issues by granting almost EUR 5 million annually to non-governmental bodies. It is expected that these non-governmental bodies assist the Commission with the information and advice necessary for the development of health policies and the implementation of the Programme objectives and priorities. It is also expected that non-governmental bodies will work on increased health literacy and promotion of healthy life styles, the organisation of science policy conferences and contribute to the optimisation of healthcare activities and practices by providing feedback from and facilitating communication with patients thus empowering them. A prize for non-governmental organisations is organised annually by the Health Programme for encouraging those organisation that made a significant contribution fighting against the Ebola outbreak in 2015, reducing antimicrobial resistance in 2016, and for the promotion of vaccination in 2017. Objective 2: Protect Union citizens from serious cross-border health threats In brief, actions funded under this objective are geared towards ensuring on the ground safety, i.e. it included the possibility of switching ‘mode’ from preparation to response mode in the event of an outbreak.

For instance during the Ebola and Zika outbreaks, part of the funds of the programme were used to support interventions to limit the spread of these threats by strengthening Member State preparedness and response in particular through the actions of the Health Security Committee (entry screening, medical evacuations, prevention of transmission in transport and hospital settings). The budget in 2014-2016 for strengthening EU response to health threats amounted to EUR 11 million. Objective 3: Contribute to innovative, efficient and sustainable health systems

Health Technology Assessment (HTA) Based on the lessons, successes and products of the earlier EUnetHTA Joint Actions , the third Health Programme in 2015 provided EUR 12 million for a third Joint Action on HTA in 2016-2020. The cooperation has grown to include 81 organisations from 29 countries which constitute a network of strong partners across Europe working together for better access to health technologies for Europeans. This joint action contributes to the use, quality and efficiency of joint HTA work at European level and supports evidence-based, sustainable and equitable choices in healthcare and health technologies and support re-use in regional and national HTA reports and activities.

The previous joint actions produced in total 20 Joint Assessment, 15 on pharmaceuticals and 5 on medical devices. The target of the third joint action is to have by 2020, a total of 80 Joint Health Technology Assessments done including on pharmaceuticals and medical devices. Although the joint actions have been successful in building the necessary trust between HTA bodies to establish methodologies, tools and piloting of joint assessments, they have also showed some shortcomings. Notably, 1) the non-sustainable financing (i.e. Joint Actions are only supposed to "kick-start" cooperation and are not a tool to sustain scientific and technical cooperation indefinitely) , 2) limited uptake of joint work (i.e. joint assessments or jointly agreed tools and methodologies, are not always used in national/regional HTA activities) and 3) a project based model not providing the necessary continuity of established work (i.e. the time need to set up and close a Joint Action and negotiate a new one, lead to important production gaps, during which no joint assessments or scientific work was performed) . Innovation and ehealth The overall ambition from EU Member States (MS) is to better include eHealth into health policy and better align eHealth investments to health needs. A central aspect is the transferability of health data across borde