EUROPEAN COMMISSION Brussels, 22.6.2015 COM(2015) 306 final REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Implementation of the second Programme of Community action in the field of health in 2013 {SWD(2015) 122 final}



Introduction This report focuses on the Health Programme’s implementation in 2013. This was the last year of the implementation of the Second Health Programme established by Decision 1350/2007/EC of the European Parliament and of the Council of 23 October 2007. The Programme started on 1 January 2008 and ended on 31 December 2013. Under Article 13(1) of the Programme Decision, the Commission shall annually report to the Health Programme Committee on all actions and projects funded through the programme, and keep the European Parliament and the Council informed. This report meets this requirement. It provides detailed information on the 2013 budget and its execution. The accompanying Staff Working Document in Annex 1 presents a set of examples of the key actions which were funded under the programme mainly in 2009-13 and which delivered substantial results. Overview tables detailing all actions co-funded and contracts provided can be found in Annexes 2-10. The programme, with a total budget of EUR 321 500 000, provided a wide range of funding instruments in order to achieve its objectives. These were: actions co-financed with Member State authorities (‘joint actions’), projects, co-funding for conferences and operating grants to specifically support non-governmental organisations and networks, direct agreements with international organisations, public procurement and other actions. The Second Health Programme was the main instrument to implement the EU Health Strategy, and contributed to achieving the EU 2020 objectives on smart and sustainable growth. The programme’s main aim was to complement, support and add value to the policies of the Member States, and contribute to increased solidarity and prosperity in the European Union by protecting and promoting human health and safety and improving public health. This aim was broken down into three objectives: — to improve citizens’ health security, — to promote health, including the reduction of health inequalities, — to generate and disseminate health information and knowledge. Working towards reaching the three main objectives Various actions were co-funded under each objective. In the area of health security, disease outbreaks do not respect borders. Therefore, it is essential to ensure that countries and communities across the EU are well prepared to respond to communicable and non-communicable diseases. The programme contributed to this. Regarding the second objective, demographic changes and ageing in particular are major challenges of every European society. Through the programme, Member States and the EU have been able to help promote health and reduce health inequalities, including support towards increasing healthy life years and promoting healthy ageing. For example, the programme has helped to: provide a better understanding of the issue of smoking uptake by young people and by women in particular, raise awareness on cardiovascular disease and diabetes, implement screening for cervical and colorectal cancers, and develop a worldwide online source of information on rare diseases. To achieve the third objective, the programme has helped create synergies and improve evidence for policy making by developing and transferring health information and knowledge across the EU. Projects have also specifically supported innovation in health, including on improving understanding of how to set up electronic health records and introducing personalised medicine. In addition, the programme contributed to preparing, developing and implementing EU health policy action. Actions were funded focusing on implementing legislation, for instance in the fields of tobacco control and substances of human origin, on health inequalities, in support of the Commission strategy on, ‘Solidarity in Health: Reducing Health Inequalities in the EU’, and on cross-border health threats and patients’ rights in cross-border healthcare. Lastly, in the area of health services, access to high quality and safe healthcare, together with sound scientific advice and risk assessment, contribute to patient safety in the EU. The programme supported several actions on these topics, as well as the work of the scientific committees.

Working with and providing support to a wide range of public health players Over its six years of operation, from 2008 to 2013, the programme contributed significantly to supporting health policy action at EU and Member State level and helped the Member States, stakeholders and the EU to develop effective policies for the benefit of EU citizens. Many scientists, experts, academics, patients and civil society organisations came together under different themes to pool resources and knowledge to innovate and to provide added value for EU citizens. Seizing the new range of funding instruments, work on the Commission’s and Member States’ key public health priorities could be advanced through joint actions. In total, 30 were co-funded for more than EUR 60 million. They covered themes as wide-ranging as rare diseases, health technology assessment and health workforce. Important civil society stakeholders were supported through the operating grant instrument. Their work helped the programme reach out to citizens. By co-funding pan-EU conferences, the programme enabled European exchanges and provided additional communication and dissemination opportunities. Nearly 150 pan-EU projects, financially supported with more than 100 million euros, allowed the European public health community to develop, test and implement a vast range of tools such as handbooks, guidelines and inventories to contribute to achieving the programme’s objectives. Looking ahead … While the detailed evaluation of the Second Health Programme will be forthcoming in 2015, this report gives a comprehensive overview of its implementation in 2013, highlighting several actions that came to an end that year.



Table of Contents

Introduction Budget implementation 1.1 Budget 1.2 Priorities for 2013 and financing mechanisms 1.3 Implementation of the operational budget by financing mechanism 1.4 Calls for proposals

1.5 Direct grant agreements with international organisations 1.6 Procurements (service contracts) 1.7 Other actions Implementation of the operational budget by programme objectives 1.8 Global budget consumption in 2013 1.9 Health security 1.10 Health promotion 1.11 Health Information

budget implementation 1.1Budget The budget for the Second Health Programme 2008-13 was EUR 321.5 million. The budget set out in the work plan for 2013 was EUR 55 509 000, broken down as follows: Operational expenditure: EUR 49 800 000, corresponding to budget line 17 03 06 — EU action in the field of health; Administrative expenditure: EUR 1 500 000, corresponding to budget line 17 01 04 02 - Expenditure on administrative management. The total operational budget was EUR 51 924 359 and the total administrative budget was EUR 1 542 363. This included EFTA/EEA and Croatia credits and recovery credits from previous budget years. The Executive Agency for Health and Consumers (EAHC) has been providing the Commission with technical, scientific and administrative assistance in implementing the Health Programme since 2005. EAHC organises annual calls for proposals, coordinates the evaluation of submissions, and negotiates, signs and manages related grant agreements. It is also responsible for many procurement procedures. In 2013, EAHC managed

EUR 42 279 481.64, while the Commission managed the remaining EUR 9 299 988.99 covering procurement and other actions. 1.2Priorities for 2013 and financing mechanisms The priorities for 2013 were set out in Commission Implementing Decision 2012/C 378/07 of 28 November 2012 concerning the adoption of the 2013 work plan and related criteria.

The following financing mechanisms were used to implement the work plan for 2013: Project grants were awarded to projects involving several partners, usually public health bodies and non-governmental organisations (NGOs). The maximum EU contribution is 60 % of eligible costs. However, the EU contribution may go up to 80 % if a proposal meets the criteria for exceptional utility. Operating grants were awarded to non-profit organisations or specialised networks active in areas corresponding to the programme’s three strands (corresponding to the three objectives): health promotion, health threats and health information. Such bodies must be non-governmental, non-profit, and independent of industry or other conflicting interests and have as their primary objectives one or more of the programme’s objectives. The maximum EU contribution is 60 % of their annual operating costs. However, the EU contribution may go up to 80 % if a proposal meets the criteria for exceptional utility. Grants for joint actions were awarded to Member State authorities or bodies designated by them. The maximum EU contribution is 50 %. However, the EU contribution may go up to 70 % if a proposal meets the criteria for exceptional utility. Exceptional utility co-financing of 70 % was granted for the joint action ‘Facilitating collaboration among the Member States for the effective operation of the pharmacovigilance system in the EU’ because of its contribution to the effective implementation of EU legislation in this field. Conference grants were awarded towards conferences on public health issues, organised by public bodies or non-profit organisations and the EU Council Presidencies. The maximum EU contribution is 50 % of eligible costs and the maximum amount is EUR 100 000. Direct grant agreements with international organisations were awarded to international organisations active in the area of public health. The maximum EU contribution is 60 %. Procurement (service contracts) was used to purchase services, such as scientific studies, evaluations, studies, data procurement and IT applications. The programme fully covers the cost of procurement. Competitive selection and award procedures were used to select actions for funding. Competitive selection and award procedures are not used for direct grant agreements and conferences organised by Council Presidencies because in those cases competitive procedures are either not allowed under the specific rules or are not used in practice. Administrative credits covered expenditure such as studies, meetings of experts, information and publication costs, and technical and administrative assistance for IT systems. 1.3Implementation of the operational budget by financing mechanism Type of financing mechanism Implementation € Share of mechanism in total executed budget Calls for proposals 34 672 104.60 68 % Project grants 14 633 503.00 28 % Conference grants 1 125 467.60 2 % Managed by EAHC 1 025 467.60 - Managed by DG SANCO 100 000.00 - Operating grants 5 474 491.00 11 % Grants for joint actions 13 438 643.00 26 % Direct grant agreements 1 100 000.00 2 % Procurement (service contracts) 11 485 709.46 22 % Managed by EAHC 6 107 377.04 12 % Managed by DG SANCO 5 378 332.42 10 % Other actions 4 321 656.57 8 % Executed budget in 2013 51 579 470.63 100 % Total available budget 51 924 359.33 Credits not used 344 888.70 Level of budget execution 99.33 % By way of comparison, project grants in 2012 amounted to EUR 15.7 million and grants for joint actions EUR 8.9 million. The budgets for other financing mechanisms are similar to those in 2012: conference grants EUR 0.75 million, operating grants EUR 4.3 million, direct grants EUR 2.6 million, and procurement EUR 14.2 million. 1.4Calls for proposals Four calls for proposals — for projects, conferences, operating grants and joint actions —were launched on 22 December 2012 on the Public Health website on EUROPA and on the EAHC website. The calls were also published in the Official Journal of the European Union. The calls closed on 22 March 2013. Most applications were received from main partners in EU-15 Member States, who accounted for 82 % of project applications, 80 % of conference grant applications, 100 % of operating grant applications, and four fifths of joint action applications. EAHC organised a joint action workshop in December 2012 and a joint action quality assurance workshop in February 2013. An information day with a focus on the European innovation partnership on active and healthy ageing was organized in Brussels and, general information days in Italy and Greece. Guidelines for applicants were made available on the EAHC website. The EAHC helpdesk also provided assistance and practical help. Altogether, 165 applications were submitted, for an amount totalling EUR 83 650 303. Of these, seven proposals were excluded in the screening phase. Out of the 158 remaining applications, 53 (32.9 %) were funded. Applications were evaluated in accordance with the rules and criteria set out in Commission Implementing Decision

2012/C 378/6 and the calls for proposals. 32 external experts from 18 countries took part in the evaluation process. The experts were drawn from a list established following a call for expressions of interest entitled ‘Experts for the second programme of Community action in the field of health in various evaluation activities’. The evaluation process took place in two stages. In the first stage, three external evaluators reviewed each proposal. A consolidated evaluation report for each proposal was drawn up at a meeting organised by EAHC.

In the second stage, the evaluation committee checked that the evaluators had complied with the relevant rules and criteria. It then drew up final lists of proposals recommended for funding, together with reserve lists. The evaluation committee comprised representatives from the Directorate-General for Health and Consumers, the Directorate-General for Research and Innovation and from EAHC. The Health Programme Committee issued a favourable opinion on the actions proposed for funding at its meeting on 29 June 2013. The related awarding Commission Decision was adopted on 29 October 2013. 1.4.1Project grants In all, 67 proposals were submitted in response to the call for proposals for projects. Nine proposals were recommended for funding and three were placed on a reserve list. In the end, 11 projects (16 % of the total) were funded, for a total of EUR 14 633 503.00. Their distribution among the programme strands was as follows: Health security: EUR 2 609 911.00 (two projects) Health promotion: EUR 12 023 592.00 (nine projects) Annex 2 contains a table of the projects funded. The EAHC database provides abstracts of the projects. 91 % of the successful projects were presented by main partners located in EU-15 countries. The participation rate of EU-12 countries as associated partners was only 14 %. 1.4.2Conference grants A total of 47 proposals were submitted in response to the call for proposals for conferences. Eleven proposals were recommended for funding and three were put on the reserve list. In the end, 14 conferences (30 % of the proposals received) were co-funded based on the competitive call for proposals and two conferences were organised by the Presidencies of the European Council. The total budget for conference grants was EUR 1 125 467.60. Their distribution among the programme strands was as follows: Health promotion: EUR 371 603.60 (four conferences + two conferences organised by the Greek and Lithuanian Council Presidencies) Health information: EUR 753 864.00 (10 conferences) The conferences addressed the following topics: Alzheimer’s disease, rare diseases, organ transplantation, alcohol, mental health, ageing, migrant and ethnic minority health, HIV/AIDS, living donation of organs and chronic diseases. Several larger public health conferences were also co-funded: the annual conference of the European Public Health Association (EUPHA), the World Health Summit, the European Health Forum in Gastein and the 6th Global Patients Forum. The Lithuanian Council Presidency conference focused on mental health, and the Greek Council Presidency conference focused on nutrition and physical activity. Annex 3 and Annex 4 contain tables listing the conferences funded. The EAHC database provides abstracts of the conferences and the conference proceedings themselves. 1.4.3Operating grants A total of 45 proposals were submitted in response to the call for proposals for operating grants. Of these, 20 were proposed for funding and four were placed on a reserve list. In the end, 22 proposals (eight new and 14 renewals) were funded (49 % of the proposals received) for a total of EUR 5 474 491.00. New operating grants Netherlands Organisation for Applied Scientific Research (TNO), to host the European network for action on ageing and physical activity (EUNAAPA) Association of Schools of Public Health in the European Region (ASPHER) Special Olympics Europe Euroasia Foundation (SOEEF) European Federation of Allergy and Airways Diseases Patients’ Associations (EFA) Institut National de la Santé et la Recherche Médicale (INSERM), to host the ORPHANET-network University Court of the University of St Andrews, to host the health behaviour in school-aged children (HBSC) survey network University of Ulster, to support the EUROCAT-network on congenital anomalies Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre, to host the Surveillance of cerebral palsy in Europe (SCPE) network Renewals Alzheimer Europe EUROPA DONNA (The European Breast Cancer Coalition) European Alcohol Policy Alliance (EURO-Care) European Network for Smoking and Tobacco Prevention (ENSP) The European Organisation for Rare Diseases (EURORDIS) European Public Health Alliance (EPHA) European Patients’ Forum (EPF) PREVENT (for the European network on workplace health promotion) Stichting AIDS Fonds Soa AIDS Nederland (for the AIDS Action Europe network) Stichting Health Action International (HAI) Fundación Vasca de Innovación e Investigación Sanitarias (for the network of neonatal intensive care units) International Association for Ambulatory Surgery (IAAS) Statens Serum institute (for the EURO-MoMo network: real-time mortality monitoring across Europe) CBO BV (for the Schools for Health in Europe (SHE) network)

Annex 5 contains a table listing the operating grants funded. The EAHC database provides abstracts of these. 1.4.4Joint actions Five proposals for joint actions were submitted and funded for a total of EUR 13 438 643.00. They were distributed among the programme strands as follows: Health security: EUR 4 298 700.00 (two joint actions) Health promotion: EUR 9 139 943.00 (three joint actions) These joint actions, which involved a large number of Member States and other countries taking part in the programme, focused on the following topics: pharmacovigilance, cancer control, reducing alcohol-related harm, chronic diseases, assisted reproductive technologies and haematopoietic stem cells for transplantation. Annex 6 contains a table listing the joint actions funded. The EAHC database provides abstracts of these. 1.5Direct grant agreements with international organisations In all, five direct grant agreements were signed, for a total of EUR 1 100 000 as follows: 1.World Health Organisation (WHO): 1.1.European obesity surveillance initiative 1.2.European validation of minimal information model for patient safety incident

reporting and learning 1.3.Integrated surveillance of non-communicable diseases 2.Organisation for Economic Cooperation and Development (OECD): 2.1.Training for health professionals 2.2.Health at a glance 2014 Annex 7 contains a table listing the direct grant agreements that were funded. 1.6Procurements (service contracts)

DG SANCO signed service contracts under the health security, health promotion and health information strands of the Health Programme and specific requests for IT services under existing framework contracts. The overall public procurement budget managed by DG SANCO amounted to EUR 5 378 332.42. EAHC managed 26 service contracts (seven under health security, 12 under health promotion and nine under health information) for a total of EUR 6 107 377.04. The amounts per strand and authorising organisation were as follows: Programme objective Tenders/contracts SANCO Tenders/contracts EAHC Total tenders/ contracts Health security 1 482 661.12 1 420 790.80 2 903 451.92 Health promotion 1 022 113.64 3 504 417.50 4 526 531.14 Health information 1 191 357.11 1 182 168.74 2 373 525.85 Horizontal (IT services) 1 682 200.55 0 1 682 200.55 Total 5 378 332.42 6 107 377.04 11 485 709.46 These service contracts covered needs as specified in the work plan for 2013: evaluation and monitoring of actions and policies, studies, advice, data and information on health, scientific and technical assistance, communication, dissemination, awareness-raising activities and IT applications to support policies. Annexes 8 and 9 provide more detail about the service contracts signed. 1.7Other actions EUR 4 830 000 was earmarked for other actions in 2013. This covered the following activities: Other actions Special indemnities to experts for their participation in and work for the EU scientific committees, as provided for in Commission Decision 2008/721/EC System inspection in countries exporting active substances for medicinal products for human use to the EU An administrative agreement with the Joint Research Centre (JRC) for the analysis of incident reporting Other actions — continued Indemnities to members of a multi-sectoral and independent expert panel to provide advice on effective ways of investing in health Administrative agreement with the JRC to set up a sustainable platform to coordinate and maintain registries and networks on rare diseases Sub-delegation to Eurostat to improve timeliness and comparability of health data Membership fee for the European Observatory on health policies and health systems Annex 10 provides more detail about the funding made available for the other actions Implementation of the operational budget by programme objectives 1.8Global budget consumption in 2013 The graph below illustrates how the budget was divided up between the three stands of the programme in 2013. A total of EUR 10 980 585.92 was spent on health security,

EUR 28 739 819.74 on health promotion and EUR 10 167 905.12 on health information. Finally, EUR 1 682 200.55 was invested in IT services necessary to support the three strands. 1.9Health security EUR 10 980 585.92 – 22 % of the operational budget in 2013