EUROPEAN COMMISSION Brussels, 6.11.2020 COM(2020) 691 final REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Implementation of the third programme of Union action in the field of health (2018)

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Table of Contents INTRODUCTION HIGHLIGHTS OF THE YEAR BUDGET IMPLEMENTATION 1. Priorities 2. Execution of the operational budget by financing mechanism 3. Beneficiaries MAIN COMMUNICATION ACTIONS



INTRODUCTION This report covers the implementation of the annual work programme for 2018 (2018 AWP) of the third health programme for 2014-2020 (‘the programme’). Article 13(1) of the Programme Regulation states that the European Commission must report to the Health Programme Committee on the implementation of all actions funded through the programme, and must keep the European Parliament and the Council informed. This report, which provides information on the 2018 budget and how it was used, is intended to meet the second requirement. The Commission staff working document accompanying this report presents the key actions co-funded under the programme whose results became available in 2018, together with tables detailing all co-funded activities and contracts. It also includes information on the actions implemented under the main thematic priorities of previous AWPs whose results also became available in 2018. The 2018 AWP was marked by the first ever call for projects to support the implementation of existing best practices identified and validated on the basis of agreed criteria by the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases . Under Objective 1 (Promote health, prevent diseases and foster supportive environments for healthy lifestyles), five projects were funded with a total EU contribution of EUR 6.8 million to support best practices for promoting health and preventing non-communicable diseases to reduce health inequalities and scale up integrated care. Under Objective 2 (Protect Union citizens from serious cross-border health threats), the focus in 2018 was on strengthening preparedness, including laboratory capacities, and on implementing international health regulations in the EU. Joint action was launched to build capacity to counter health threats in EU countries, including stepping up cooperation with neighbouring countries. The overall EU contribution was EUR 7.9 million. Objective 3 (Contribute to innovative, efficient and sustainable health systems) saw the launch of several actions. Examples include the voluntary cooperation between Member States’ national pricing and reimbursement authorities on the pricing of pharmaceutical products (known as EURIPID cooperation), the second phase of the information and communication campaign on the new Regulation on medical devices, and meetings of the EU expert group working with effective ways of investing in health and the joint assessment of medical devices. Under Objective 4 (Facilitate access to better and safer healthcare for Union citizens), the programme funded:

·the Orpha Codes project, designed to expand coding for identifying rare diseases in national health information and reimbursement systems; ·the administration of the 23 existing European Reference Networks (ERNs) and the establishment of a new ERN, eUROGEN; and ·the continued operation up to 2021 of the Orphanet Network, bringing together national teams throughout the EU to collect, validate and disseminate key information on rare diseases. The Commission and the Consumers, Health, Agriculture and Food Executive Agency (Chafea) ensure that the programme’s results are publicised widely through appropriate communication and dissemination activities. Member States and non-EU countries participating in the programme are also encouraged to engage in disseminating the results of the co-funded actions and to seek synergies with other EU funding programmes. These promotional activities included holding 8 information days to promote the funding opportunities offered under the 2018 AWP, in cooperation with the network of national focal points (NFPs). In parallel with these initiatives, the Commission is responsible for monitoring the implementation of the third health programme. Chafea and DG SANTE have contributed to the data gathering study, which involved examining documents on 70 actions (technical reports, sustainability plans, evaluations, etc.), to review and extract relevant data for the baseline analysis and modelling of impacts. This study informed the Commission’s decision on future EU action on health in the multi-annual financial framework (MFF) for 2021-2027 .



HIGHLIGHTS OF THE YEAR The 2018 AWP broadly addressed the four specific objectives of the health programme. Under Objective 1 (Promote health, prevent diseases and foster supportive environments for healthy lifestyles), Chafea launched three calls for projects on the implementation of best practices on promotion of good health, prevention of non-communicable diseases and scaling up integrated care. The first call dealt with the implementation of existing best practices identified by the Member States and validated according to agreed criteria by the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases. Two project grants were co-funded to support the transfer of best practices and help scale them up at national and European level. These practices fell into the areas of health promotion, prevention of non-communicable diseases and reduction of health inequalities. 1.The purpose of the #Stay Healthy - Cardiovascular Risk Prevention (YOUNG50) project is to transfer the Italian CARDIO 50 screening model programme for active prevention in 50 year-olds, which constitutes best practice, to Lithuania, Romania and Luxembourg. Through early detection, treatment of risk factors and follow-up, it is expected to benefit those who receive counselling and to improve their lifestyles or medical parameters. EUR 983 255 in EU funding was made available. 2.The European Physical Activity on Prescription model (EUPAP) project is designed to transfer the Swedish model for physical activity on prescription, classed as best practice, to 10 other EU countries. EU funding amounted to EUR 1 346 154. The second call focused on integrated care, the proposed actions being designed to help healthcare authorities reform their healthcare systems. The set objective was to help local and regional health authorities develop the capacity needed to implement integrated care by following the main design principles and related building blocks identified in this area by the expert group on health systems performance assessment . The following two projects were funded: 1.Evidence-based guidance to scale up integrated care in Europe (VIGOUR) . The project, based on a consortium of 15 beneficiaries from 9 EU countries and the UK, received EU funding of EUR 1 827 608. 2.Personalised knowledge transfer and access to tailored evidence-based assets on integrated care (SCIROCCO Exchange) . The project explores the readiness of local environments for the adoption of integrated care, using the SCIROCCO online self-assessment tool to understand local needs and the reasons for transferring the integrated care mode. This will serve as a basis for designing a tailored capacity-building approach and personalised assistance to national and regional health and social care authorities. The project, based on a consortium of 14 beneficiaries from 8 EU countries and the UK, received EU funding of EUR 1 508 988. The third call focused on nutrition, expanding the transfer of the wholegrain promotion initiatives to interested countries. The purpose of the European action on wholegrain partnerships (WholEUGrain) is to facilitate the transfer of the Danish best practice model for a wholegrain partnership and to promote good health through healthy diets. By developing country-based wholegrain public/private partnerships, the project will support disease prevention, reduce inequalities and establish supportive environments for healthy lifestyles. The project brings together five partners from four countries and received EU funding of EUR 855 410. Through a service contract under the same objective, Chafea undertook other activities related to alcohol-related harm reduction to support implementation of best practices, including those identified by EU countries under the joint action on reducing alcohol-related harm (2014-2016). Chafea also managed a number of studies supporting the implementation of EU legislation on tobacco products. Under Objective 2 (Protect Union citizens from serious cross-border health threats), the SHARP joint action got under way in EU countries and other countries participating in the programme. The purpose of the joint action is to improve preparedness in the EU to cope with serious cross-border threats to health and support the implementation of international health regulations. A further aim is to step up the implementation of EU legislation on serious cross-border threats to health. The joint action involves 26 associated partners, 33 affiliated entities and 9 collaborating partners in 30 countries (24 EU countries, 3 EEA/EFTA members and 3 European neighbourhood countries). It received an EU contribution of EUR 7.9 million.

Under Objective 3 (Contribute to innovative, efficient and sustainable health systems), a series of activities was funded that involved support to the implementation of the regulations on medical devices and in vitro diagnostic medical devices, including the development and implementation of the new European Database for Medical Devices (EUDAMED). Finally, under Objective 4 (Facilitate access to better and safer healthcare for Union citizens) the ERNs received financial support for their coordination, particularly in the form of 3-year grants running until the end of the programme. The programme also supported the independent assessment of healthcare providers applying to join existing ERNs. The 2018 AWP also included direct grant funding for one additional ERN (eUROGEN), as well as the Orphanet database network.



BUDGET IMPLEMENTATION The overall budget for the third health programme for 2014-2020 was EUR 449.4 million. This includes EUR 30.6 million in operating costs for Chafea, which is mandated by the Commission to manage the programme. Chafea has been providing the Commission with technical, scientific and administrative assistance in implementing the health programme since 2005. It organises annual calls for proposals, coordinates the evaluation of submissions, negotiates, signs and manages grant agreements and disseminates the results of the actions. It is also responsible for most procurement procedures. The budget set out in the work plan for 2018 was EUR 68 325 543.65, broken down as follows: ·operational expenditure EUR 60 467 000, corresponding to budget line 17 03 01 (‘Encouraging innovation in health, increasing the sustainability of health systems and protecting Union citizens from serious cross-border health threats’); ·additional contributions of EUR 1 952 043.65 from EFTA/EEA and other non-EU countries participating in the programme; ·administrative expenditure EUR 1 500 000, corresponding to budget line 17 01 04 02; ·budget for Chafea’s operating costs EUR 4 406 500, corresponding to budget line 17 01 06 02. The operational budget totalled EUR 62 419 043. EUR 61 322 254.98 (98.24%) were committed under the 2018 AWP. Chafea committed EUR 45 976 468.52 and DG SANTE EUR 15 345 786.46, covering part of procurement and other actions. Of the overall commitment, unused appropriations amounted to EUR 1 096 788.67, corresponding to 1.76% of the total. 1.Priorities In 2018, the total operational budget implemented (EUR 61 322 254.98) was assigned to the four specific programme objectives as follows: 1.Health promotion - EUR 15 796 420.66 (26% of the operational budget) for promoting health, preventing diseases and fostering supportive environments for healthy lifestyles, taking into account the ‘health in all policies’ principle; 2.Health threats – EUR 7 900 000 (13% of the operational budget) for protecting Union citizens from serious cross-border health threats; 3.Health systems – EUR 8 422 838.09 (14% of the operational budget) for contributing to innovative, efficient and sustainable health systems; 4.Better and safer healthcare – EUR 25 455 254.83 (42% of the operational budget) for facilitating access to better and safer healthcare for Union citizens. In addition, cross-cutting activities (IT activities, communication, reimbursement of expert evaluators) accounted for EUR 3 747 741.40 (6% of the operational budget). Chart 1: Operational budget by third health programme objectives in 2018

In the 2018 budget allocation to the programme’s various thematic priorities, Chart 2 below shows that the ERNs rank highest, followed by capacity building to cope with health threats, with chronic diseases in third place. Chart 2: Operational budget by thematic priority in 2018 To reach its objectives, the programme was implemented through a wide range of funding instruments. These are: ·project grants, including the specific mono-beneficiary grant agreement for the ERNs for rare, low-prevalence and complex diseases; ·operating grants to support non-governmental organisations (NGOs); ·actions co-financed with Member State authorities (joint actions, JAs); ·direct grant agreements (DGAs) with international organisations; ·public procurement; and ·other actions, such as support to the scientific committees, administrative agreements with the Joint Research Centre and EUROSTAT, and grants for Presidency conferences. Competitive calls were used to select actions for funding, e.g. for projects and procurement. JAs, grants to international organisations and conferences organised by European Council presidencies are DGAs because of their monopoly situations (de facto or de jure). External reviewers (JAs), DG SANTE and Chafea officials evaluate the proposals to ensure that these co-funded actions meet certain quality standards. The administrative budget covered expenditure on matters such as study meetings of experts, communication, and technical and administrative assistance for IT systems.

2.Execution of the operational budget by financing mechanism Type of financing mechanism Implementation (EUR) Share of mechanism in total implemented budget (%) Grants under call for proposals or invitation 30 674 796.67 50.02 Project grants, including other DGA projects 11 095 795.01 18.09 ERN actions 3-year specific grant agreements (SGAs) under Framework Partnership Agreement 13 691 043.13 22.33 Operating grants for NGOs 5 887 958.53 9.60 JA grant 7 900 000.00 12.88 Conference grants to the Member States holding the EU Presidency 166 000.00 0.27 DGAs with international organisations 4 020 000.00 6.56 Procurement (service contracts), prizes and cross-cutting actions 8 924 955.22 14.55 Managed by CHAFEA 2 618 012.85 4.27 Managed by DG SANTE 6 306 942.37 10.28 Other actions 9 636 503.09 15.71 Managed by CHAFEA 597 659.00 0.97 Managed by DG SANTE 9 038 844.09 14.74 Budget implemented of 2018 AWP 61 322 254.98 98.24 Managed by CHAFEA 45 976 468.52 73.66 Managed by DG SANTE 15 345 786.46 24.59 Total available budget of 2018 AWP 62 419 043.65 Not used 1 096 788.67 1.76 by CHAFEA 1 096 788.67 by DG SANTE 0.00 3.Beneficiaries In 2018, Chafea and DG SANTE signed more than 262 grants and contracts with a range of beneficiaries and service providers: governmental organisations, academic institutions, NGOs, private companies, and individual experts. Other beneficiaries included international organisations and EU departments. There were 423 beneficiaries in total, the two main categories being private companies (for procurement and other actions) and governmental organisations (for JAs and projects). Chart 3 shows the various groups of beneficiaries. Chart 3: Third health programme beneficiaries in 2018 – main categories