EUROPEAN COMMISSION

Brussels, 5.8.2019

SWD(2019) 316 final

COMMISSION STAFF WORKING DOCUMENT

Accompanying the document

Report from the Commission to the European Parliament and the Council

Implementation of the third Programme of Union action in the field of health in 2016

{COM(2019) 365 final}

TABLE OF CONTENTS

JOINT ACTIONS    

1.    Joint action on rare diseases — EUCERD JA    

2.    Joint action on a cross-border patient registries initiative — PARENT JA    

3.    Joint action on quality assurance exercises and networking on the detection of highly infectious pathogens — (QUANDHIP JA) & joint action on efficient response to highly dangerous and emerging pathogens at EU level (EMERGE JA)    

4.    Joint action on improving quality in HIV prevention — Quality Action JA    

PROJECTS    

1.    Activation of stratification strategies and results of the interventions on frail patients of healthcare services — ASSEHS    

2.    Advancing care coordination & telehealth deployment programme — ACT    

3.    European Haemophilia Network — EUHANET    

4.    Coordinated action in the aviation sector to control public health threats — AIRSAN    

OPERATING GRANTS    

1.    Tuberculosis Europe Coalition: Strengthening the role of civil society within the TB response in Europe - TBEC    

2.    AIDS Action Europe — network continuity and innovation — AAE    

DIRECT GRANTS TO INTERNATIONAL ORGANISATIONS    

1.    OECD: Preparation of EU Health Report — ‘State of Health in the European Union’ and country specific analysis    

2.    WHO: (The European Observatory on Health Systems and Policies) on country specific knowledge    

CALLS FOR TENDERS    

1.    SERVICE CONTRACT: Development of a manual and toolbox for assessing the European Reference Networks    

2.    SERVICE CONTRACT: Study on the regulation of advanced therapies    

3.    SERVICE CONTRACT: Organisation of a workshop targeting media, civil society and health professionals relating to the implementation of the Decision 1082/2013/EU on serious cross- border threats to health; and to conduct a study on the availability/supply capacities of critical medical countermeasures at Member State level and in the industry and to organise an inter-sectoral table top exercise on outbreak coordination and response involving public health and other sectors    

4.    SERVICE CONTRACT: Organisation of a command post exercise on serious cross-border threats to health falling under the chemical and environmental categories    

5.    SERVICE CONTRACT: Support of the implementation of Decision 1082/2013/EU especially as regards preparedness and response activities in the context of the Ebola Epidemic in West Africa, in particular the organisation of four workshops to be embedded as parallel sessions in a Commission organised conference    

6.    SERVICE CONTRACT: Study on the mapping of best practices and development of testing methods and procedures for identifying characterising flavours in tobacco products    

7.    SERVICE CONTRACT: Assessment of citizens’ exposure to tobacco marketing    

8.    SERVICE CONTRACT: Study on the identification of potential risks to public health associated with the use of refillable electronic cigarettes and on the development of technical specifications for refill mechanisms — PRECISE    

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

1.    Dissemination activities carried out in 2016    

2.    Other actions    

Scientific Committees    

Expert panel on effective ways of investing in health    

CALLS FOR PROPOSALS    

Project grants    

European Reference Networks (sole beneficiary grants)    

Operating grants    

JOINT ACTIONS    

DIRECT GRANT AGREEMENTS AND PRESIDENCY CONFERENCES    

PROCUREMENTS (SERVICE CONTRACTS)    

OTHER ACTIONS    

DETAILED OVERVIEW OF THE REPORTING YEAR    

Funding per thematic priority and financial instrument (all amounts in EUR)    

Introduction

This Commission staff working document accompanies the report on the implementation of the third health programme in 2016. The report provides a detailed overview of all the actions funded under the annual work programme for 2016 (AWP 2016) and highlights some of the key co-funded initiatives that aim to implement EU health policy and legislation. This staff working document also presents important results of actions co-funded under the second health programme, which ended in late 2015 and in 2016, and which were in some cases followed up by actions even larger in scope and ambition. It includes actions on overarching themes (such as rare diseases and European Reference Networks, care coordination, registries, health security — especially in light of the Ebola epidemic and tobacco) which have been included in successive financing decisions. Lastly, it provides useful figures and statistics and the full list of co-funded initiatives and contracts financed under the third health programme's operating budget in 2016.

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

A number of initiatives co-funded under the second health programme, which ended in late 2015 and in 2016, produced important results that were taken up and built on at national or EU level. Several of these are described below. More information about these and other projects and joint actions co-funded under the second and third health programmes can be found in the database managed by the Consumers, Health, Agriculture and Food Executive Agency (Chafea) 1 .

JOINT ACTIONS

1.Joint action on rare diseases — EUCERD JA

Background information

The EUCERD JA ran from March 2012 to October 2015, with co-funding of up to EUR 2 994 162.00. It involved eight partners in eight EU countries (Belgium, Finland, France, Germany, Italy, Portugal, Spain and the United Kingdom).

In mid-2015, the joint action on promoting implementation of recommendations on policy, information and data for rare diseases (RD-ACTION) took the work of EUCERD JA forward. Under this joint action, the partnership was enlarged to 35 partners from 22 countries. This solidified the commitment of the EU and other countries involved to work together on rare diseases.

Brief description

Supporting the activities and mandate of the European Union Committee of Experts on Rare Diseases, the EUCERD 2 joint action comprised five main areas of work:

-implementing plans and strategies for rare diseases at national level;

-standardising rare disease nomenclatures at international level;

-mapping the specialised social services already available;

-integrating rare diseases into mainstream social policies and services; and

-mainstreaming rare diseases initiatives across EU policy areas and across Member States.

Specific results

As a policy support action, the joint action mainly produced guidance and evidence-based tools for rare disease policies and activities at national and EU level.

Key outcomes/outputs include:

-increased visibility of rare diseases in international disease nomenclatures (ICD-11, OrphaCodes and human phenotype terminologies), which improved the recognition of rare diseases by national health and social insurance systems;

-faster implementation of comprehensive national rare diseases action plans (the action organised 24 national conferences bringing together all the stakeholders);

-wider recognition of the value of specialised social services thanks to the extensive mapping of existing services and guidelines for developing them at national level;

-quality criteria for centres of expertise and European Reference Networks (ERNs) in the field of rare diseases: the joint action's work was endorsed on the recommendation of the European Commission Expert Group on Rare Diseases and the criteria were integrated in the European Commission's delegated and implementing decisions under Directive 2011/24/EU on patients’ rights in cross-border health care 3 ;

-a minimum data set for rare diseases patient registries produced in collaboration with the EPIRARE project and the PARENT JA.

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

2.Joint action on a cross-border patient registries initiative — PARENT JA

Background information

The PARENT JA ran from May 2012 to December 2015 with co-funding of up to EUR 2 016 231.00. It involved 11 partners in 10 EU countries (Croatia, Finland Greece, Hungary, Italy, Malta, Portugal, Slovakia, Slovenia and Spain).

Brief description

The PARENT JA aimed to provide Member States with guidelines and recommendations on improving the quality of patient registries and their readiness for interoperability to encourage and improve the use of clinical data for public health purposes.

The PARENT JA:

-provided a comprehensive overview of the current situation in EU countries regarding patient registries;

-created a pilot ‘Registry of Registries of national patient registries’ and developed recommendations, guidelines and IT tools for efficient and rational governance of patient registries;

-provided a plan of activities and policies for registries to support the implementation of Directive 2011/24/EU on patients’ rights in cross-border health care 6 ; and

-developed guidance on secondary use of registry data, including the Registry of Registries and methodological and governance guidelines, to be used by patient registration initiatives beyond the joint action's lifecycle.

Specific results

The PARENT JA provided guidance to Member States on developing interoperable and coherent patient registries with comparable elements to support existing EU projects. This took the form of a toolkit covering topics such as how to set up a patient registry, what ICT tools to use, the recommended information models, and the relationship to and dependence on electronic health records.

It also introduced a ‘Knowledge Management Platform — Wiki’ containing documents such as guidelines, state-of-the-art reviews and best practices so that all Member States can access such information.

The action's results are available on the project website 7 and in Chafea’s health programme database 8 .

3.Joint action on quality assurance exercises and networking on the detection of highly infectious pathogens — (QUANDHIP JA) & joint action on efficient response to highly dangerous and emerging pathogens at EU level (EMERGE JA)

Background information

The QUANDHIP JA ran from August 2011 to the end of January 2015 with co-funding of EUR 3 315 981. It involved 37 highly specialised and advanced laboratories from 21 European countries (Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Spain, Sweden and the United Kingdom).

The EMERGE JA built on this work, running from June 2015 to the end of March 2019 and extended the partnership to over 40 diagnostic laboratories. It aimed to: (i) evaluate new diagnostic methods for high-threat pathogens; (ii) carry out quality assurance and training; and (iii) ensure best approaches for laboratory responsiveness during outbreaks.

Brief description

The primary aim was to bring together two pre-existing EU laboratory networks — one dealing with high-threat bacteria (risk group 3) and the other with highly infectious viruses (risk group 4). The QUANDHIP network ensured the extensive exchange of best diagnostic strategies to support a joint European response to outbreaks of highly pathogenic infectious agents, including the generation of a bio-diverse repository of reference materials. The joint action also provided a supportive European infrastructure and strategy for External Quality Assurance Exercises (EQAE), training, and biosafety/biosecurity quality management.

Specific results

Key achievements of QUANDHIP JA support include:

-The network on highly pathogenic bacteria (NIB) performed three EQAE focused on B. anthracis, Y. pestis, F. tularensis, C. burnetii, B. pseudomallei, B. mallei and B. melitensis-group.

-The network on highly pathogenic viruses (NIV) performed EQAE focusing on the Lassa, Marburg and Ebola viruses.

-The joint action produced a revised integrated European checklist for laboratory biorisk management in the handling of high consequence risk group 3 and 4 agents (ECL-Biorisk).

-The joint action developed standard operational procedures (SOP) for coordinating laboratory activities during outbreaks.

The SOP was applied in the following specific cases: (a) when the network provided technical support with the shipping of and testing for Hantavirus infections; (b) when assessing the diagnostic capabilities to combat the novel coronavirus (hCoV-EMC) in different countries; (c) during the laboratory investigation of anthrax cases among heroin users; and most recently (d) in the cases of H7N9 influenza and the 2014-2015 Ebola outbreak.

For the Ebola outbreak in particular, the network allowed EU countries to confirm suspected cases.

These experiences were all included in an updated SOP.

The EMERGE JA has built on these concrete outcomes. It has: (i) conducted additional quality assurance exercises; (ii) expanded the training of participating laboratories accrediting them as national reference laboratories; and (iii) demonstrated the benefits to the participating Member States.

The action's results are available on the project website 9 and in Chafea’s health programme database 10 .

4.Joint action on improving quality in HIV prevention — Quality Action JA

Background information

The Quality Action JA ran from March 2013 to the end of February 2016 with co-funding of EUR 1 493 175. It involved 25 associated partners from 22 countries (Austria, Belgium, Bulgaria, the Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Hungary, Latvia, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom).

Brief description

This joint action aimed to improve the quality of the response to HIV and AIDS across Europe by integrating evidence-based quality improvement (including quality assurance) practices into HIV prevention.

With key partners in the area, the joint action developed practical tools and materials to maximise the quality of HIV prevention projects and programmes in the participating countries.

The Quality Action JA also developed two key documents to gain policy support and create an enabling environment for quality improvement:

‒the Charter for Quality in HIV Prevention 11 , which sets out quality principles, criteria and key activities for improving quality and gives practitioners, experts, policy makers and others the opportunity to commit to improving their work in HIV prevention; and

‒The Policy Kit 12 , which provides policy makers with the arguments and concrete actions for integrating quality improvement into HIV prevention policies, strategies and action plans.

Specific results

The Quality Action JA yielded the following tangible results:

- five practical quality improvement tools 13  (with relevant supporting materials) in a variety of European languages: (i) Quality in prevention (QIP); (ii) Participatory quality development (PQD), (iii) Succeed — a knowledge base tool; (iv) the SCHIFF (programme tool) method; and (v) a quality assurance tool for health promotion and prevention for people who inject drugs ('PIQA');

-a database of 98 case studies of practical quality improvement tool applications; and

-a broad consensus on principles and criteria for quality improvement, represented by the Charter for Quality in HIV prevention and a policy kit as a concise advocacy tool for further dissemination.

In terms of capacity building, this innovative partnership created a large network of experts, having trained more than 400 quality improvement trainers and facilitators from 25 different European countries. It also succeeded in integrating quality improvement in HIV prevention.

The action's results are available on the project website 14 and in Chafea’s health programme database 15 .

PROJECTS

1.Activation of stratification strategies and results of the interventions on frail patients of healthcare services — ASSEHS

Background information

The ASSEHS project ran from March 2013 to July 2016 with co-funding of EUR 1 342,356. It involved eight associated partners from four countries (France, Italy, the Netherlands and Spain).

Brief description

In 2013, the health programme started to co-fund actions to support the European Innovation Partnership on Active and Healthy Ageing (EIP-AHA), a flagship initiative to address the challenges of an ageing society. To face the challenge, EU health systems are becoming more proactive, adopting integrated care models and using health risk management tools to provide personalised and patient-centred services.

Such 'risk stratification tools' can help to identify complex frail and high-risk patients and keep them on health services' radars. More importantly, these tools can ensure appropriate interventions for this vulnerable population group and help people remain in their homes and communities for as long as possible and delay or entirely avoid them needing to be cared for in an acute care setting 16 .

Specific results

The ASSEHS project has delivered:

-an extensive analysis of the various risk stratification tools 17 available (note that frail patients are not identified by simple algorithms and that current models use a variety of important data, such as diagnoses, socio-demographic data, pharmacy data, prior use of health care and socio-economic data);

-a white paper on the deployment of stratification methods, supporting the transferability value for other regions and healthcare systems.

An analysis of risk stratification models and the lessons learnt from their use in the participating EU countries has concluded that they are highly useful and should be extended to other EU countries and regions.

The action's results are available on the project website 18 and in Chafea’s health programme database 19 .

2.Advancing care coordination & telehealth deployment programme — ACT

Background information

The ACT programme ran from March 2013 to the end of February 2016 with co-funding of EUR 1 596 383.63. It involved 14 partners from six countries (Germany, Greece, Italy, the Netherlands, Spain and the United Kingdom).

Brief description

Many consider connected care to be essential for more efficient, patient-centred, continuous and integrated health and social care for ageing people in the EU. However, although many local connected care pilot programmes are successful, they fail to scale up, even at national level, and health systems do not fully benefit from their potential impact.

The ACT consortium carried out a comprehensive two-and-a-half year scientific evaluation of data from different connected health programmes in five European regions and conducted 2 500 surveys and group interviews with patients, care providers, experts and other stakeholders. The cross-border nature of this evaluation is particularly valuable as it allows us to compare different EU programmes and learn from them.

The action's final report provides local and regional health authorities with solutions for large-scale deployment of connected care interventions across Europe. This has the potential to transform care for millions of chronically ill people and generate significant savings for EU healthcare systems.

Specific results

The ACT programme was able to:

-gather data and good practices from different regions across the EU;

-determine a baseline for how care coordination and telehealth works in these regions;

-conduct an iterative evaluation of care structures and procedures;

-select best practices; and

-disseminate findings so that good practices can be extended to other regions.

Its key outcome is the evaluation of how to effectively deploy coordinated care and telehealth services on a large scale. Although this evaluation was based on the five participating regions (Catalonia, the Basque Country, Lombardy, Groningen and Scotland), its conclusions can be applied throughout the EU

These results have been published in a best practice ‘cookbook’ 20 , which describes how these insights can be used to extend care coordination and telehealth to other regions in Europe.

The action's results are available on the project website 21 and in Chafea’s health programme database 22 .

3.European Haemophilia Network — EUHANET

Background information

The EUHANET project 23 ran from June 2012 to the end of November 2015 with co-funding of up to EUR 885 614. It involved six partners from four countries (the United Kingdom, Belgium, Italy and the Netherlands).

Brief description

EUHANET was set up to improve care for European citizens with inherited bleeding disorders and was a 'pilot' ERN. Although knowledge about these disorders is improving over time, the related improvement in treatment and care varies across Europe. European health systems are diverse and patient care varies significantly, for instance in terms of the quality of facilities and the types of therapies available.

EUHANET had four main areas of activity:

-assessing and classifying the quality of care currently provided by Haemophilia centres in Europe;

-creating and maintaining a website to provide information on rare bleeding disorders and their treatment;

-monitoring the safety of treatments for inherited bleeding disorders via the European Haemophilia Safety Surveillance 24  (EUHASS) system; and

-collecting prospective information on the diagnosis, care and treatment of patients with extremely rare bleeding disorders to enter into the Prospective Rare Bleeding Disorders Database 25 (PRO-RBDD).

Specific results

EUHANET developed and put in place a European Haemophilia Centre certification scheme. It produced a standard document to categorise treatment centres into one of two types: (i) a European Haemophilia Treatment Centre (EHTC); or (ii) a European Haemophilia Comprehensive Care Centre (EHCCC).

EUHANET created and still runs the Haemophilia central website 26 , which is a one-stop-shop for finding key information about inherited bleeding disorders.

The website also includes links to the Haemophilia Centre Locator, a user-friendly search engine that locates European Haemophilia Centres. This is accessible from any computer, tablet or mobile phone. It gives the five nearest Haemophilia centres for any address, shows them on a map, and provides addresses and contact information for each centre. This is particularly useful for patients with bleeding disorders who are travelling in Europe.

EUHANET continued and extended the EUHASS adverse event reporting system that monitors the safety of treatments for people with Haemophilia and other inherited bleeding disorders in Europe. It also further developed the Prospective Rare Bleeding Disorders Database (PRO-RBDD).

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

4.Coordinated action in the aviation sector to control public health threats — AIRSAN

Background information

The AIRSAN project ran from April 2013 to the end of December 2015 with co-funding of EUR 598 566. It involved seven partners in five EU countries (Belgium, Germany, Greece, the Netherlands and Poland), and 20 collaborating partners representing international organisations working on aviation and health (WHO, ICAO and EASA).

Brief description

AIRSAN's general objective was to support an efficient, multi-sector, multi-stakeholder response to public health threats in air transport that is consistent across the EU.

To achieve this, the project actively involved national public health and civil aviation authorities, local public health authorities working in airports, airport and airline management and medical services across the EU.

Specific results

-setting up the AIRSAN network of national public health and civil aviation authorities, local public health authorities in airports, airport and airline management and medical services across the EU;

-setting up the AIRSAN communication platform linked to the AIRSAN website to gather information and exchange information;

-conducting a review of existing guidance documents on the control of public health threats in air transport, resulting in the AIRSAN bibliography;

-developing and testing AIRSAN guidance documents on the control of public health threats in air transport; and

-developing the AIRSAN training tool to help countries implement the AIRSAN guidance documents.

The action's results are available on the project website 29 and in Chafea’s health programme database 30 .

OPERATING GRANTS

13 non-governmental organisations (NGOs) that signed a framework partnership agreement (FPA) in 2014 31 were invited to submit their proposals for a specific grant agreement (SGA) under the 2016 AWP to cover their annual recurrent operational expenses for the financial year 2017 32 .

10 FPAs and their SGAs respond to Objective 1 of the third health programme: ‘Promote health, prevent diseases and foster supportive environments for healthy lifestyles taking into account the ‘health in all policies’ principle’, and the other three respond to Objective 4: ‘Facilitate access to better and safer healthcare for Union citizens’.

Table 1: List of applicant organisations that were awarded an FPA and subsequent SGAs

Throughout 2016, in line with their SGAs, the above organisations achieved their objectives, produced work of value to their stakeholders and supported the Directorate-General for Health and Food Safety (DG SANTE) policy initiatives in their areas of activity. An example of the work and outcomes of two organisations with an SGA that are active in the area of tuberculosis is presented below.

1.Tuberculosis Europe Coalition: Strengthening the role of civil society within the TB response in Europe    - TBEC

Background information

The Tuberculosis Europe Coalition (TBEC) operating grant ran from January 2015 to December 2017 with co-funding of EUR 245 670 (or around EUR 82 000 per year). During this period, the network membership expanded to 303 members, covering 31 countries in the European region, including 18 EU countries and all tuberculosis (TB) high burden countries.

Brief description

The TBEC is an advocacy network that brings together civil society representatives (individuals and organisations) from across the WHO European Region to strengthen the role of civil society in the regional response to TB and to increase the political and financial commitment required to effectively control the epidemic in the region.

TBEC operations aimed to:

-map civil society stakeholders across the WHO European Region;

-facilitate access to information and resources for capacity building for target groups;

-conduct outreach to civil society across the region to expand the network and build relationships with target groups;

-engage with decision makers on behalf of civil society across the region; and

-manage the network effectively to implement the annual work programme.

Specific results

TBEC helped strengthen the role of civil society in Europe's TB response, with the mapping of civil society working on TB in 43 countries in the region, including all 28 EU Member States.

TBEC conducted a qualitative and quantitative mapping of civil society stakeholders in 30 target countries, including at least 15 EU countries. Its working method included country visits (e.g. Romania), online training and webinars, a ‘join us’ invitation on the website, attending various conferences and meetings, and networking.

Target countries including Latvia, Lithuania, Estonia, Romania and Bulgaria were mapped to strengthen TBEC’s understanding of the transition process to solely national funding of TB diagnostics, treatment and prevention programmes in upcoming years. The civil society mapping in Romania and Bulgaria also provided better understanding of key TB-related civil society issues, ahead of the Bulgarian EU Presidency in 2018.

In 2016 TBEC also published the annual report on ‘How to leverage European Union funding for health in Eastern Europe and Central Asia’ and a position paper entitled ‘Transitioning from donor support HIV and TB programmes in Eastern Europe and Central Asia: challenges and effective solutions’.

Both documents addressed the transition process in middle-income countries that will experience withdrawal of international donor funding on TB in the upcoming years. The policy paper aims to convince international and regional decision makers and donors, as well as national governments, that a rushed transition process can undermine previous achievements in TB diagnostics, treatment and prevention, as in the case of Romania. The thematic report provides more information about various EU funding opportunities to civil society organisations in the WHO Europe region to help ease the transition process and supplement low levels of national funding. Both the thematic report and policy paper were translated into Russian, which was highly appreciated by civil society in the European region, including in the Baltic countries and Bulgaria.

In 2016, the TBEC Secretariat also gave two webinars (in Russian and English). Throughout the year, TBEC continued to engage with the EU, the WHO and the Global Fund to shape TB policy (e.g. transition, ambulatory care and antimicrobial resistance) by participating in meetings and conferences and by publishing policy reports. TBEC Secretariat members also continued to chair the WHO Regional Collaborative Committee (RCC) on TB, continuously strengthening their collaboration with WHO Europe and other technical partners.

Further information is available on TBEC's website 33 and in Chafea’s health programme database 34 .

2.AIDS Action Europe — network continuity and innovation — AAE

Background information

The AAE operating grant ran from January 2015 to December 2017 with co-funding of up to EUR 773 277 (or around EUR 258 000 per year).

AAE is a central player at European level in HIV/AIDS policies and interventions, and pursues its objectives in cooperation with a comprehensive, pan-European network. AAE is a European-wide network, covering EU Member States, neighbouring countries and countries in Eastern Europe and Central Asia. It comprises 440 NGOs, national networks, AIDS service organisations, activists and community-based groups of people living with HIV in 47 countries in the WHO European Region. It has 162 members in the 28 EU Member States and six in Norway and Switzerland.

Brief description

AAE’s work under the FPA 2015-2017 follows the three principles stated in the 2016 SGA:

-that civil society’s contributions to regional and national HIV/AIDS policies and programmes are effective and meaningful;

-that a strong and effective working network is established by improved collaboration, linking and learning, and good practice exchange related to HIV/AIDS among NGOs, networks, policy makers and other stakeholders; and

-that the functioning of the network is ensured by optimised internal management processes.

Specific results.

AAE's results/achievements include:

-improved impact of the Civil Society Forum on European HIV/AIDS, viral hepatitis and tuberculosis policy development, thanks to meetings organised on EU policies;

-the HIV/AIDS Clearinghouse, which enables quick and easy cross-border information sharing, was used more actively and by a wider audience (20 publications were uploaded onto the Clearinghouse, 48 news and events were posted on the website - mainly in the bilingual e-newsletter);

-AAE increased its social media output, with 156 Facebook posts, 115 tweets and 104 vkontakte posts shared;

-regional trainings were conducted on the topic of affordability and pricing of medications;

-the European HIV Legal Forum network was created to improve access to HIV prevention, counselling and testing, treatment, care and support for all those who have limited access to HIV services due to legal obstacles; and

-AAE participated to the UNAIDS Programme Coordinating Board in 2016-2017, ensuring that European issues were heard and properly addressed in the global agenda.

More information is available on the AAE's website 35 and in Chafea’s health programme database 36 .

DIRECT GRANTS TO INTERNATIONAL ORGANISATIONS

1.OECD: Preparation of EU Health Report — ‘State of Health in the European Union’ and country specific analysis

2.WHO: (The European Observatory on Health Systems and Policies) on country specific knowledge

In 2016, the Commission launched the first two-year cycle of the State of Health in the EU, leading to the publication in 2017 of the first country health profiles and the companion report.

This was made possible by two direct grants:

‒The direct grant to the Organisation for Economic Cooperation and Development (OECD) that ran for 24 months, from July 2016 to June 2018 with a maximum co-funding of EUR 1 200 000.

‒The direct grant to the WHO hosting the European Observatory on Health Systems and Policies that ran for 18 months, from May 2016 to December 2017, with a maximum co-funding of EUR 750 000 37 .

Background information

The State of Health in the EU initiative aimed to bring together the expertise and knowledge of the OECD and the European Observatory on Health Systems and Policies and to create a mechanism for mutual learning and voluntary exchange to help Member States in their evidence-based policy- making.

It followed on from other significant efforts to align health information collected by the EU, the OECD and the WHO.

Brief description

The State of Health in the EU is a European Commission initiative to provide policy makers, interested stakeholders and health professionals with factual, comparative data and insights into health and health systems in EU countries.

The two-year State of Health in the EU cycle has four main stages:

-the 'Health at a Glance: Europe' report, prepared by the OECD, gives a horizontal starting point;

-the individual country health profiles, adapted to the context and specific situation of each EU country, assesses the strengths and challenges of their respective health systems;

-a companion report published alongside the country health profiles draws cross-cutting conclusions, links common policy priorities across EU countries, and explores the scope for mutual learning; and in addition

-at the close of the two-year cycle, health authorities in EU countries can request voluntary exchanges with the experts behind the State of Health in the EU, to discuss findings and potential policy responses.

Specific results

The concise, policy relevant profiles were based on a transparent and consistent methodology, using both quantitative and qualitative data, yet flexibly adapted to the context of each EU Member State.

Each country health profile provided a short synthesis of:

-health status;

-the determinants of health, focusing on behavioural risk factors;

-the organisation of the health system; and

-the effectiveness, accessibility and resilience of the health system.

The companion report drew cross-cutting conclusions from the 28 country health profiles on:

-the added value of a shift towards health promotion and disease prevention and of measures to counter health inequalities;

-the key role for primary care to guide patients through the health system and help avoid wasteful spending;

-the prospective of integrated care to reduce fragmented service delivery;

-the positive impact of proactive health workforce planning and forecasting in increasing health systems' resilience to future developments; and

-the potential of patient-centred data for policy and practice.

CALLS FOR TENDERS

1.SERVICE CONTRACT: Development of a manual and toolbox for assessing the European Reference Networks

Background information

The service contract was carried out by the PACE-ERN consortium and was led by EURORDIS (members of the consortium include Accreditation Europe ASBL, European Hospital and the Healthcare Federation). The maximum contract price was EUR 500 000. It kicked off in December 2014 with a duration of 16 month.

Brief description

This service contract aimed to help the Commission develop the methodology and technical tools to assess the ‘Networks and healthcare providers’ proposals under Article 12 of Directive 2011/24/EU on patients’ rights in cross-border healthcare 38  and relevant implementing measures.

The Directive requires that the Commission support Member States in developing European Reference Networks (ERNs) between healthcare providers and centres of expertise by establishing the legal framework for such networks. The Commission was therefore tasked with adopting implementing measures on the criteria and conditions to be fulfilled by such networks and healthcare providers, and on the establishment and evaluation of the networks.

The Commission adopted Delegated Decision 2014/286/EU 39 on 10 March 2014 on the criteria and conditions that networks and healthcare providers that want to join a network must fulfil. It also adopted Implementing Decision 2014/287EU 40 on the criteria for the establishment and evaluation of the networks. Both Decisions entered into force on 27 May 2014.

The implementing decision establishes that each applicant network and its healthcare providers should be technically assessed according to the criteria set out in Delegated Decision 2014/286/EU. The assessment should include an exhaustive documentation review and on-site audits of a selected number of applicants. It should be carried out by an independent assessment body appointed by the European Commission on the basis of a common assessment manual.

Specific results

The service contract resulted in the development of an ERN assessment manual and toolbox 41 that addresses all assessment steps from the publication of the call for networks to their approval and covers the materials and methods to be used and the expected end products.

The assessment manual and toolbox were used to assess candidate ERNs that applied under the related call for expression of interest launched by Chafea on behalf of the European Commission in 2016.

Chafea selected independent assessment bodies (IABs) which, based on the manual and toolbox, carried out the technical assessment of the ERN proposals. For example, they:

-assessed the documentation submitted by the candidate networks and applicant health care providers;

-conducted on-site audits of applicant healthcare providers; and

-produced a final technical assessment report of the network proposal and applicant healthcare providers.

The above steps underpinned the Board of Member States' decision on December 2016 to approve the 23 applicant ERNs in line with the conditions and requirements of the Implementing (2014/287/EU) and Delegated Decision (2014/286/EU).

2.SERVICE CONTRACT: Study on the regulation of advanced therapies

The contractor ECORYS NEDERLANDS B.V (the Netherlands with consortium members National Institute for Health and Welfare (Finland) and Universita Cattolica Del Sacro Cuore (Italy) carried out the study on the regulation of advanced therapies outside the EU). The contract ran for 10 months starting in April 2015 for a maximum price of EUR 161 500.

Brief description

This service contract aimed to produce a study with comprehensive information about the advanced therapies already are available to patients and about those that are under development in the USA, Canada, Japan and South Korea, and about the regulatory frameworks governing advanced therapies in these countries.

The outcome of the study was intended to feed into a reflection process on EU legislation on advanced therapies to ensure that the legislation is adequately adapted to the needs of this emerging sector.

Specific results

Advanced therapies are currently regulated in two ways in the countries studied under this service contract.

In Canada, the USA and South Korea most advanced therapies are formally regulated as medicinal products (biologics), although consideration is given to the specific characteristics of advanced therapies in the framework of the individual decision-making procedure for marketing authorisation, often in close consultation with the developers.

Given that the regulatory frameworks in these three countries are largely similar, differences in research activities are not considered to be a direct outcome of regulatory framework differences but most likely stem from other characteristics of the innovation system for advanced therapies in each of the selected countries. However, the assessment of these characteristics was beyond the scope of this study.

Japan has put in place a specific regulatory framework for advanced therapies. However, as it entered into force only recently, it is difficult to measure its impact on advanced therapies.

The final report with all the findings is available on the website of DG SANTE 42 .

3.SERVICE CONTRACT: Organisation of a workshop targeting media, civil society and health professionals relating to the implementation of the Decision 1082/2013/EU on serious cross- border threats to health; and to conduct a study on the availability/supply capacities of critical medical countermeasures at Member State level and in the industry and to organise an inter-sectoral table top exercise on outbreak coordination and response involving public health and other sectors

Background information

The service contract's aim was to support the implementation of Decision 1082/2013/EU on serious cross-border threats to health 43 , which covers several health security areas.

The CELESTE consortium led by Public Health England and including the Swedish Defence Agency, Umea University (Sweden) and Istituto Superiore di Sanita (Italy), signed a contract to carry out two tasks:

1)organise a workshop ‘targeting media, civil society and health professionals relating to the implementation of the Decision 1082/2013/EU on serious cross-border threats to health’; and

2)conduct a study on the ‘availability/supply capacities of critical medical countermeasures at Member States level and in the industry and to organise an inter-sectoral table to exercise on outbreak coordination and response involving public health and other sectors’. The contract ran for 7 months starting in December 2015 and had a maximum price of EUR 585 612.

Brief description

The contractor organised a workshop for media, civil society and health professionals on the implementation of the serious cross-border health threats decision (Decision 1082/2013/EU). The workshop aimed to identify ways to ensure consistent and professional risk and crisis communication with the public and stakeholders, in support of the work of the Health Security Committee Communicators’ Network. There were participants from 21 EU Member States and Norway with a crisis communication background in a health setting, nine journalists and one civil society organisation (the European Federation of Nurses Association) active in the field of public health. There were also participants from DG SANTE, Chafea, ECDC and WHO.

The study identified needs for medical counter measures in the framework of the serious cross-border health threats decision. It also identified conditions under which Member States could use the joint procurement mechanism for medical countermeasures against serious cross-border health threats to improve their preparedness. Similarly, it assessed the feasibility and willingness of Member States to jointly procure such medical countermeasures. The contractor also organised a table top exercise on climate change and serious cross-border threats to health involving public health players and specialists in other sectors.

This inter-sectoral table top exercise, called 'Orion', explored the potential challenges of climate change for the EU. Its main purpose was to bring together public health and environmental/climate change specialists to improve the crisis response to climate change-related public health threats affecting EU countries and agencies. The scientific evidence base was considered to be important for informing decision making and linking it to climate-focused research. Participants included representatives from public health bodies and environmental/climate change specialists from 21 EU Member States and Iceland. There were also participants from DG SANTE, ECDC, DG CLIMA and WHO.

Specific results

The study's outcomes generally supported the Commission's ongoing work and specifically the pursuit of the Joint Procurement Agreement.

The workshop identified several key themes for the way forward, namely: (i) more training on communicating with all groups involved in crisis communication; (ii) clearer policy and procedures; and (iii) a common database of templates, plans and tools that could be used for the planning and response phases of an incident.

The table top exercise highlighted several challenges, particularly the need to increase collaboration and strengthen inter-sectoral coordination and the need for specific communication strategies and standard operating procedures for climate change. The exercise also led to specific recommendations on developing EU guidelines to support the disinfection of aircraft and developing an early warning and response (EWRS) type system that would include the reporting of all hazards (N.B. this has now been implemented). This wide-ranging exercise was a unique opportunity to gather EU Member States to discuss the climate change challenge and to produce a series of constructive recommendations.

4.SERVICE CONTRACT: Organisation of a command post exercise on serious cross-border threats to health falling under the chemical and environmental categories

Background information

The CELESTE consortium led by Public Health England and including the Swedish Defence Agency, Umea University (Sweden) and Istituto Superiore di Sanita (Italy), signed a contract to organise a command post exercise on chemical and environment-related serious cross-border health threats. The contract ran for 12 months from January 2015 and had a maximum price of EUR 458, 988.

The command post exercise aimed to provide EU Member States, European Agencies and other interested organisations with an opportunity to test the adequacy of existing plans, systems, communication processes and tools to meet the requirements of the decision on serious cross-border health threats (Decision 1082/2013/EU) 44 . The decision applies to all 28 EU Member States and sets out an ‘all hazards’ approach for alerting a public health emergency of international concern that includes serious cross-border threats to health from biological, chemical, environmental events and evens of unknown origin.

The command post exercise, called 'Quicksilver Plus', took place over 2 days. Participants included representatives from the public health and chemical sectors and communication specialists from the Health Security Committee Communicators’ Network. 15 EU Member States and 1 EEA country (Norway) participated in the exercise along with participants from ECDC, WHO, DG SANTE, DG HOME, DG ECHO and the Joint Research Centre.

The 'Quicksilver Plus' exercise built on the 'Quicksilver' exercise organised in 2013. It helped participants increase their understanding of the different roles and responsibilities in the strategic management of chemical and environment-related cross-border events and improve their preparedness and resilience.

Specific results:

The main strategic findings from 'Quicksilver' were:

-further EU-wide education and training is needed to ensure stakeholders fully understand the decision's impact and requirements;

-the process for the prompt sharing of information between the relevant EU and national institutions needs to be improved to ensure rapid risk assessment and crisis communication; and

-the Health Security Committee Communicator’s Network needs to be further developed and awareness of its role and responsibilities needs to be increased.

The 'Quicksilver Plus' exercise provided strong evidence that good progress had been made in all these areas and highlighted the following key areas for continued improvement:

-The Health Security Committee’s strategic role to provide situational awareness and to coordinate the cross-border response to public health incidents. A standard situational awareness template could be used to ensure a common understanding between Member States and the Commission.

-Some Member States should consider reviewing their structures and capacities across all sectors to align with the serious cross-border health threats decision and to further increase their awareness of International Health Regulations, including their in-country reporting processes.

Feedback confirmed that most participants agreed that the exercise allowed them to practise their emergency role and to use supporting documents and tools. It also helped them understand their role and responsibilities during an emergency and increased their knowledge of the response concept, structure and procedures.

5.SERVICE CONTRACT: Support of the implementation of Decision 1082/2013/EU especially as regards preparedness and response activities in the context of the Ebola Epidemic in West Africa, in particular the organisation of four workshops to be embedded as parallel sessions in a Commission organised conference

Background information

The CELESTE consortium led by Public Health England and including the Swedish Defence Agency, Umea University (Sweden), and Istituto Superiore di Sanita (Italy), signed a contract to support the implementation of the serious cross-border health threats decision (Decision 1082/2013/EU) especially preparedness and response activities in the context of the Ebola epidemic in West Africa. Its role was to organise four workshops in the form of parallel sessions in a conference organised by the Commission. The contract ran for 10 months from April 2015 and had a maximum price of EUR 499 719.

Brief description

DG SANTE, together with the Luxembourg Presidency, organised a conference on ‘lessons learned for public health from the Ebola outbreak in West Africa — how to improve preparedness and response in the EU for future outbreaks’. The aim of this conference was to identify learning points arising from the Ebola epidemic which are crucial to strengthen health security in the EU, better prepare for similar crises and ensure that the EU can respond rapidly, flexibly and effectively to emergencies and disease outbreaks in the future.

The conference gathered over 350 participants from health authorities, EU bodies, international organisations and NGOs. It included national experts, organisers of projects on risk and crisis management and communicators involved in the outbreak response in West Africa and the preparedness and response in the EU.

The conference included four parallel workshops on different aspects of the Ebola crisis:

-The Ebola outbreak as a complex crisis: the EU response and inter-sectoral cooperation

-Good practices and innovation for pre-clinical and clinical management of Ebola virus disease

-Communication activities addressed to the public and health professionals

-The EU preparedness and response planning as part of global health security

Brief description

Considerations and recommendations generated by the four workshops include:

1.A peer review mechanism could help Member States improve their national preparedness plans taking into account past and current initiatives on independent country evaluations at global and regional level.

2.Article 17 of the serious cross-border health threats decision (Decision 1082/2013/EU) 45 on the coordination of the Health Security Committee should contribute to a stronger decision making and to a reinforced strategic response.

3.The Joint Procurement Agreement needs to be further developed and mechanisms for its effective use — involving relevant training exercises — during an ongoing emergency situation needs to be explored.

4.State-of-the-art capacity for airborne medical evacuation (Medevac) and ground transportation in Europe requires a shared and long-term financial commitment of countries and international institutions.

5.Infection prevention and control standards need to be put in place before an emergency from an infectious disease of high impact (IDHI) occurs. This applies in particular to critical structures such as emergency departments or intensive care units.

6.Global collaboration and funding in research is needed to develop a strategic plan for globally coordinated research and development for IDHI that encompasses inter-epidemic and epidemic clinical epidemiology, vaccine and drug development, diagnostic standardisation, and personal protective equipment.

7.Possibilities for joint communications between EU/EEA Member States, the EU, civil society and key stakeholders (such as NGOs and health professionals’ organisations) to more systematically communicate must be explored.

8.The EU capacity to prepare and respond to emergencies with a public health implication should be strengthened by operationalising the European Medical Corps, as part of the European emergency response capacity under the EU Civil Protection Mechanism, and of the Global Health Emergency Workforce and other such bodies.

The conference's recommendations were forwarded to the Health Council of December 2015. These recommendations contributed to EU and national preparedness activities in the following years.

Information on the conference is available on DG SANTE’s website 46 .

6.SERVICE CONTRACT: Study on the mapping of best practices and development of testing methods and procedures for identifying characterising flavours in tobacco products

Background information

A Consortium led by the Dutch National Institute for Public Health and the Environment (RIVM) carried out the study to map best practices and develop testing methods and procedures to identify characterising flavours in tobacco products. The contract ran for 11 months from August 2014 and had a maximum price of EUR 195 400. (The study was published in the second half of 2016.)

Brief description

The main purpose was to help the Commission implement the newly revised Tobacco Product Directive 47 , specifically to determine whether a tobacco product has a characterising flavour and to set maximum levels for additives or combinations of additives that cause the characterising flavour.

The study presented the most suitable method/s to decide whether a tobacco product has a characterising flavour other than tobacco. It also developed, based on a number of pilot tests, all documentation necessary to replicate the study, including comprehensive protocols and standard operating procedures for each step of the procedure and/or activity. It also provided a basis for establishing and operating an independent advisory panel, as referred to in the Tobacco Product Directive II 48 .

Specific results

This study produced a new method, combining sensory tests and chemical analyses, to assess whether a tobacco product has a flavour other than tobacco.

This new method involves experts who assess tobacco products by smelling them, focusing on detecting attractive flavours such as cherry, menthol or vanilla, or similar. This step is followed by a robust chemical analysis that determines any flavours. With this approach, authorities can better determine whether tobacco products placed on the EU market comply with the Directive’s rules.

The study's results helped the Commission draft rules and procedures 49 to determine whether tobacco products have a characterising flavour and provided a scientific basis for the work of the Independent Advisory Panel and the Technical Group of sensory and chemical assessors.

The final report is available on DG SANTE’s website 50 .

7.SERVICE CONTRACT: Assessment of citizens’ exposure to tobacco marketing

Background information

A Consortium led by Burson-Marsteller s.p.r.l carried out an assessment of citizens’ exposure to tobacco marketing over 10 months (from September 2014 to July 2015) for a maximum price of EUR 199 950.

Brief description

The assessment report gives the Commission a comprehensive overview of channels through which EU citizens, and in particular young people, are exposed to the marketing of tobacco products and e-cigarettes.

The marketing of tobacco products is addressed by EU legislation and recommendations such as the Tobacco Advertising Directive (2003/33/EC), the Audio-visual Media Service Directive 2010/13/EU 51 (AVMSD) (which replaced the Television Without Frontiers Directive 97/36/EC), the Tobacco Products Directive 2014/40/EU 52 and the Council Recommendation on the prevention of smoking and on initiatives to improve tobacco control (2003/54/EC) 53 . In addition, the EU and its Member States are parties to the WHO Framework Convention on Tobacco Control 54 (FCTC), adopted in 2003, which includes articles and guidelines on the advertising, promotion and sponsorship of tobacco products. Individual Member States also have laws banning various forms of tobacco advertising, although their extent and scope vary from country to country.

Specific results

The study investigated the reality of tobacco advertising and marketing in a representative sample of EU Member States. The detailed evidence provided in the report (which is available on DG SANTE’s website 55 ) sheds light on how current EU and national laws on tobacco and e-cigarette advertising are working in practice.

8.SERVICE CONTRACT: Study on the identification of potential risks to public health associated with the use of refillable electronic cigarettes and on the development of technical specifications for refill mechanisms — PRECISE

Background information

The European Regulatory Science on Tobacco (EUREST) Consortium led by the Biomedical Research Foundation of the Academy of Athens (BRFAA) in partnership with the European Network on Smoking and Tobacco Prevention (ENSP) carried out a study to identify potential public health risks associated with the use of refillable electronic cigarettes and to develop technical specifications for refill mechanisms. The contract ran for 10 months (from December 2014 to October 2015) and had a maximum price of EUR 180 450.

Brief description

The PRECISE study (Potential Risks from Electronic Cigarettes & their technical Specifications in Europe) aimed to provide the Commission with an overview of potential public health risks associated with the use of refillable electronic cigarettes and with information on technical specifications for refill mechanisms.

Specific results

The study had several interesting and tangible results:

1. The study provides an overview of the EU e-cigarette market, focusing on refillable e-cigarettes, based on a sample of EU Member States. For each of these Member States, a comprehensive evaluation of the most popular products on the market was conducted and a number of samples were purchased for further evaluation. The study also identified and assessed public health risks associated with the use of ecigarettes, particularly refillable e-cigarettes.

2. The study identifies the technical specifications for refill mechanisms, based on the aforementioned risks, stakeholder feedback, European standards already in place and the evaluation of the purchased samples. Design features were identified that may limit the risks associated with the refilling processes, and may also address requirements that e-cigarettes do not leak and are child- and tamper-proof, thereby protecting both users and non-users, especially children.

The study's results helped the Commission draft the technical standards for the refill mechanism of electronic cigarettes (Commission Implementing Decision (EU) 2016/586 56 ) and to prepare its report to the European Parliament and the Council on the potential risks to public health associated with the use of refillable electronic cigarettes (Commission Report COM(2016) 269 57 ).

The study is available on DG SANTE’s website 58 .

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

1.Dissemination activities carried out in 2016

In 2016, a number of dissemination activities were carried out to promote the health programme's results. These included:

·As in previous years, Chafea disseminated the results of EU co-financed actions electronically or at conferences and other meetings attended by relevant stakeholders. The Agency produced publications highlighting the health programme's achievements and value for money, e.g. fact sheets and brochures that illustrate that EU action can complement or stimulate other actions or fill in gaps, e.g. at Member State level. Chafea organises or participates in a range of ad hoc information and dissemination activities.

·A revamped health programme project database was developed and launched. This comprehensive, user-friendly database, maintained by Chafea, makes EU health programme deliverables available to the public for consultation or further use.

·In 2016, Chafea published brochures on: (i) rare diseases 59 , (ii) health security 60 .

·The Agency also began work to produce additional brochures in 2017, in a single request for service together with 13 info sheets covering several of the health programme's thematic priorities 61 .

In addition, Chafea continued to disseminate the health programme's results at national, EU-wide and international events. It ensured that info sheets on health programme actions on specific themes such as chronic diseases, HIV and health security were disseminated in at least three EU languages at such events. The Agency’s pop-up stand and handouts were present at more than 15 national or EU-level events, including at these major events:

1.A two-day conference on migrants' health, organised in May 2016 in close cooperation with DG SANTE, the Portuguese Directorate-General of Health, the International Organisation for Migration and the COST ADAPT expert network. This conference brought together 165 participants, mainly policy makers and experts from 25 EU countries.

2.More than 10 workshops at major conferences such as:

·the high level conference on global health security;

·the 16th international conference on integrated care (ICIC 2016);

·the 19th European Health Forum Gastein;

·'Demographics and Diversity in Europe'; and

·the 9th European Public Health conference (EPH2016).

Chafea also organised a cluster meeting on nutrition and physical activity in Budapest from 30 November to 2 December. This event brought together 90 participants, including journalists, policy makers, health and education authorities, community and experts, representatives of the WHO and the Commission. It comprised eight sessions and 40 presentations.

2.Other actions

Scientific Committees

When preparing policies and proposals on consumer safety, health and the environment, the Commission relies on independent scientific committees for sound scientific advice and for information on new and emerging problems.

Between April 2013 and March 2016, three committees provided scientifically sound advice for policy makers to ensure a high level of consumer safety, health and environmental protection that citizens expect from the EU.

These committees were:

·Scientific Committee on Consumer Safety (SCCS)

·Scientific Committee on Health and Environmental Risks (SCHER)

·Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)

The following two Scientific Committees, established by the Commission Decision C(2015)5383 62 , started a new five-year term in April 2016 that runs until March 2021:

·Scientific Committee on Consumer Safety (SCCS) 63

· Scientific Committee on Health, Environmental and Emerging Risks (SCHEER)

Only the SCENIHR and SCHER and later their successor the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) were financed by the health programme.

Key figures on SCHEER's activities between April and December 2016 64 include:

-2 SCHEER documents adopted (scientific opinions, scientific advice and statements):

oOpinion on biological effects of ultraviolet radiation relevant to health with particular reference to sunbeds for cosmetic purposes 65

oOpinion on additives used in tobacco products (Tobacco additives II) 66

-45 meeting days organised in Luxembourg (including external meetings)

-5 scientific articles published in scientific journals 67

-1 Health-EU newsletter edition dedicated to the activities of the Scientific Committees

-The amount spent on all the activities was EUR 471 381.41:

oEUR 345 221.41 68 for producing Opinions and for meetings; and

oEUR 126 160 for technical assistance (literature search, editing of opinions, website mastering, assistance for the Health-EU newsletter, dissemination activities).

As of April 2016, the committees' expenditure included EUR 38 158 for SCENIHR (for one final opinion) and EUR 4 835 for SCHER (for two final opinions and one guidance document).

Expert panel on effective ways of investing in health

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

The creation of the panel stems from the June 2011 Council conclusions on health systems, in which the European Commission was invited to initiate a process for independent and evidence-based advice on health systems to support policy making on health. Since starting its activities on 11 July 2013, the expert panel has been working consistently on topical questions issued by the Commission. The expert panel's opinions are the views of its independent scientists and do not necessarily reflect the views of the Commission.

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

The expert panel delivers opinions, which can support health policy making in the EU. These opinions are for the consideration of the Member States’ governments and authorities in charge of delivering healthcare. They are also for the consideration of various stakeholders. They aim to generate discussions at EU and national level to inform policymaking. They all focus on the added value of working at EU level in terms of mutual learning, identifying best practice and sharing knowledge.

The expert panel produced the following opinions in 2016:

·Typology of health policy reforms and framework for evaluating reform effects 69

·Best practices and potential pitfalls in public health sector commissioning from private providers 70

·Memorandum — Reflections on hospital reforms in the EU 71

·Access to health services in the European Union 72

·Disruptive Innovation. Considerations for health and health care in Europe 73

The panel's first three-year term ended in May 2016. The renewed panel of 14 members was appointed in November 2016 for a three-year term that will run until May 2019.

IMPLEMENTATION OF ANNUAL WORK PROGRAMME 2016

CALLS FOR PROPOSALS

Calls for proposals for projects and operating grants actions were launched on 4 March 2016 on the Horizon 2020 programme's participants' portal 74 , on the public health website on Europa 75 and on Chafea’s website 76 . Most applications came from the main partners (i.e. coordinators of the submitted proposals) in the EU-15 Member States. These accounted for 68% of project applications, 100% of operating grant applications and 100% of joint action applications. The percentage of partners from new EU Member States involved in the joint actions is 46.4% of all partners, whereas for projects it is 39.1%.

Chafea organised a workshop on joint actions in July 2016 and a joint action quality assurance workshop in November 2016. In addition, the health programme's national focal points organised national information days throughout April and May 2016. Guidelines for applying were made available on the participants' portal. Chafea's helpdesk also provided practical assistance.

A total of 81 project proposals including the ERNs and 13 operating grant proposals were received with a total requested budget of EUR 60 904 730.37. The available annual budget for these two categories of funding mechanism, however, was EUR 17 850 000. Eight of the project proposals were ineligible and 27 of the 73 remaining applications ended up being funded (37 %) and 46 being rejected. Applications were evaluated according to the rules and criteria set out in the annual work programme for 2016 (AWP 2016) 77 and in the calls for proposals. 23 external experts from 13 countries took part in the evaluation process. They were drawn from a list that was established following a call for expressions of interest entitled ‘call for expressions of interest in the area of public health’ 78 .

The evaluation process had two stages:

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

In the second stage, the evaluation committee checked that the evaluators had complied with the relevant rules and criteria. It then drew up final lists of proposals recommended for funding, together with reserve lists. The evaluation committee comprised representatives from DG SANTE, the Directorate-General for Research and Innovation (DG RTD) and from Chafea. The award decisions for 14 projects 79 , 13 operating grants 80 and 23 European Reference Networks (ERNs) 81 were taken by Chafea.

Project grants

Project grants were awarded to actions involving several partners, usually public health bodies and NGOs. The maximum EU contribution is 60% of the eligible costs. However, it may go up to 80% if a proposal meets the criteria for 'exceptional utility'. In 2016, two projects qualified for exceptional utility: MyHealth and ORAMMA

In total, 81 proposals were submitted to the call for proposals for projects. Of these, 12 proposals were recommended for funding and 16 were placed on a reserve list. In the end, 14 projects were funded for a total of EUR 8 795 212.04. Their distribution among the programme objectives was as follows:

1.Health promotion: EUR 6 266 372.65 (8 projects)

2.Health threats: no project call

3.Health systems: no project call

4.Better and safer healthcare: EUR 2 528 839.39 (6 projects)

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

European Reference Networks (sole beneficiary grants)

Each European Reference Networks (ERN) had to submit a proposal in order to be assessed by the independent assessment bodies (IABs) and become an approved ERN. Following the decision of the Board of Member States, each ERN also submitted a proposal for a framework partnership agreement (FPA), together with their specific grant agreement (SGA) proposal for their first year of operation.

Once the decision of the Board of Member States was taken and the 23 networks approved, Chafea invited them to participate in the grant agreement preparation phase, so that the related FPAs and SGAs could be signed as quickly as possible in the year N+1.

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

Operating grants

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

·are non-governmental;

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

·work in the public health area;

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

·pursue at least one of the health programme's specific objectives;

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

·have a balanced geographical coverage of the EU.

The maximum EU contribution is 60% of their annual operating costs, but it may increase to 80% if a proposal meets the criteria for exceptional utility. In 2016, only six operating grants qualified for exceptional utility.

At the start of the third health programme, Chafea introduced the call for a multiannual ‘framework partnership’ whereby the holders of three-year framework partnership agreements (FPAs) can apply for annual co-funding.

The AWP 2016 did not plan for an open call for operating grants, as organisations that signed an FPA for 2015-2017 were invited to submit their specific grant agreement (SGA) proposals covering their costs for 2017. Of the 14 applicants granted an FPA, only 13 received an SGA. One of the FPA holders could not submit their SGA proposal for 2016 due to the bankruptcy of the legal entity hosting the specific network of experts.

At the end of 2016, the grant preparation process was completed, corresponding to an amount of EUR 5 142 328.

All the operating grants funded are listed by objective and by priority in the below table.

JOINT ACTIONS

Grants for joint actions were awarded to competent authorities or public sector bodies and non-governmental bodies mandated by those competent authorities. The maximum EU contribution for joint actions is 60%, but may go up to 80% if a proposal meets the criteria for exceptional utility. In 2016, four out of the five joint actions qualified for exceptional utility.

The procedure for joint actions under the new health programme has changed. To assure more transparency and inclusiveness, the EU Member States and other countries participating in the third health programme nominate the competent authorities or other bodies. These nominated bodies are then invited to submit a proposal under the direct grant procedure.

Five joint actions were co-funded for a total of EUR 14 376 881.83. Distribution among the programme objectives was as follows:

·Health promotion (4 joint actions):

a.JATC Tobacco control (EUR 1 999 018.07);

b.CHRODIS-PLUS Good practices for chronic diseases (EUR 4 999 999.56);

c.INTEGRATE Integrating prevention, testing and linkage to care strategies across HIV, viral hepatitis, TB and STIs in Europe (EUR 1 999 877.08), and

d.GAPP Facilitating the authorisation of preparation process for blood and tissues and cells (EUR 1 199 824.37).

·Health threats (no joint actions)

·Health systems (no joint actions)

·Better and safer healthcare (1 joint action): JAMRAI Antimicrobial resistance and associated infections (EUR 4 178 162.75)

Each of these joint actions involved between 27 and 44 beneficiaries from EU and other countries participating in the programme.

All the joint actions funded are listed by objective and by priority in the below table.

DIRECT GRANT AGREEMENTS AND PRESIDENCY CONFERENCES

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

Six direct grant agreements were signed by Chafea for a total amount of EUR 4 450 000 as follows:

1)Four direct grants (EUR 2 150 000) were signed with the WHO for: (i) the observatory on dementia; (ii) the Framework Convention on Tobacco Control's (FCTC) Illicit Trade Protocol; (iii) migrants' health: best practices in care provision for vulnerable migrants and refugees; and (iv) the European Observatory on Health Systems and Policies on country specific knowledge and antimicrobial resistance.

2)One direct grant (EUR 1 200 000) was signed with the OECD for the preparation of the EU health report ‘State of health in the EU’ and the country specific analysis.

3)One direct grant (EUR 1 100 000) was signed with the Council of Europe on European Pharmacopoeia (EDQM) (CoE — EDQM).

All direct grant agreements funded are listed by objective and by priority in the below table.

Presidency conferences

The Presidency conferences financed under AWP 2016 included a conference under the Slovakian Presidency on ‘Structured Cooperation between Health Care Systems’ for 100 000 EUR and a technical meeting on ‘Childhood Obesity’ under the Maltese Presidency for 41 780.43 EUR. See below table.

PROCUREMENTS (SERVICE CONTRACTS)

Procurement (service contracts) was used to purchase services for a total amount of EUR 16 089 842.38. Contrary to the grants, the health programme covers the full cost of the procurement.

These service contracts cover needs as specified in the AWP 2016, namely:

·evaluation and monitoring of actions and policies;

·studies;

·provision of advice;

·data and information on health;

·scientific and technical assistance;

·communication;

·awareness raising and dissemination of the results; and

·information technology applications in support of policies.

In 2016, DG SANTE signed several service contracts and specific requests using existing framework contracts. Most of these contracts and requests were for horizontal actions such as communication and IT services for maintenance and functioning of existing IT tools.

Procurement contracts also included contracts with experts working for the scientific committees and evaluation and monitoring studies. The overall public procurement budget implemented by DG SANTE under AWP 2016 was EUR 5 633 778.84.

The overall public procurement budget implemented by Chafea under AWP 2016 was EUR 10 456 063.54. In 2016, Chafea managed 26 new market procedures for the acquisition of services (five contracts under health promotion, four contracts under health threats, five contracts under health systems and three under better and safer health care) and nine on horizontal communication.

The amounts per objective and authorising organisation were as follows:

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

OTHER ACTIONS

EUR 3 313 500 was earmarked for other actions in 2016. The ‘other actions’ include experts’ fees. For example, fees:

·for experts in the expert panel on effective ways of investing in health;

·for experts carrying out system inspection on pharmaceutical ingredients;

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

This category also includes the cost of administrative agreements with the Joint Research Centre and covers the Commission’s membership fee to the European Observatory on Health Systems and Policies. See the below table for more information on what specific actions fell under ‘other actions’.

DETAILED OVERVIEW OF THE REPORTING YEAR

Funding per thematic priority and financial instrument (all amounts in EUR)

(1)

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

(2)

The European Union Committee of Experts on Rare Diseases (EUCERD) was replaced by the European Commission Expert Group on Rare Diseases.

(3)

Commission delegated decision 2014/286/EU of 10 March 2014 defining the criteria and conditions that healthcare providers and the ERNs should fulfil. Commission implementing decision 2014/287/EU of 10 March 2014 defining criteria for establishing and evaluating ERNs.

(4)

  http://www.eucerd.eu/

(5)

  https://webgate.ec.europa.eu/chafea_pdb/health/projects/20112201/summary

(6)

  https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32011L0024

(7)

  http://www.parent-ror.eu/#/

(8)

  https://webgate.ec.europa.eu/chafea_pdb/health/projects/20112302/summary

(9)

  https://www.emerge.rki.eu/Emerge/EN/Content/Quandhip/quandhip_node.html

(10)

  https://webgate.ec.europa.eu/chafea_pdb/health/projects/20102102/summary

(11)

  https://www.qualityaction.eu/images/qact_policykit_charter.pdf

(12)

  https://www.qualityaction.eu/images/qact_policykit_03.pdf

(13)

  https://www.qualityaction.eu/wordpress/wp-content/uploads/2016/03/QualityAction_ToolSelectionGuide_20160224-1.pdf

(14)

  https://www.qualityaction.eu/

(15)

  https://webgate.ec.europa.eu/chafea_pdb/health/projects/20122102/summary

(16)

For every 1 000 patients, there will likely be close to 200 patients (20%) living with more than one chronic disease who could benefit from more intensive support. As an example, in the United States (there are no such studies covering the entire EU), this 20% of the population accounts for 80% of total health care spending. And of these ‘higher need’ patients, 5% account for nearly half of US health expenditure. Furthermore, health care spending for people with five or more chronic conditions is 17 times higher than for people with no chronic conditions.

(17)

  https://ec.europa.eu/eip/ageing/repository/population-risk-stratification-deployment-stratification-methods-basque-country_en

(18)

  http://assehs.eu/

(19)

  https://webgate.ec.europa.eu/chafea_pdb/health/projects/20131204/summary

(20)

  https://www.act-programme.eu/sites/all/themes/act/files/ACT_Cookbook_final.pdf

(21)

  https://www.act-programme.eu/

(22)

  https://webgate.ec.europa.eu/chafea_pdb/health/projects/709770/summary

(23)

  http://www.euhanet.org/

(24)

  https://www.euhass.org/

(25)

  http://eahad.org/prospective-rare-bleeding-disorders-database-pro-rbdd/

(26)

http://www.haemophiliacentral.org/ . This website provides information on bleeding disorders, treatment guidelines, clinical trials, clotting factor concentrates, haemophilia centre locations and facilities, aggregated data from EUHASS, quality control schemes, haemostatic gene mutations, haemophilia service provision in European countries. It allows users to ask generic questions and provides a news service and Haemtrack, and a telemedicine system whereby patients can enter information online about their clotting factor use at home.

(27)

  http://www.euhanet.org/

(28)

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

(29)

  http://www.airsan.eu/

(30)

  https://webgate.ec.europa.eu/chafea_pdb/health/projects/20121102/summary

(31)

14 FPAs were signed with successful applicant organisations for 2015-2018, making them eligible for financial support on an annual basis for each of the years covered by the FPA.

(32)

One of the 14 applicant organisations awarded an FPA went bankrupt in 2015 and therefore has not participated in the call for SGAs in 2016.

(33)

  http://www.tbcoalition.eu/

(34)

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

(35)

  http://www.aidsactioneurope.org

(36)

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

(37)

The EU co-funding also covered work on antimicrobial resistance.

(38)

  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011L0024&from=EN

(39)

https://publications.europa.eu/en/publication-detail/-/publication/dba7b357-dd8b-11e3-8cd4-01aa75ed71a1/language-en

(40)

  https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ%3AJOL_2014_147_R_0007

(41)

  https://ec.europa.eu/health/sites/health/files/ern/docs/amt_technicaltoolbox_en.pdf

(42)

https://ec.europa.eu/health/sites/health/files/human-use/docs/20147306_rfs_chafea_2014_health_24_060516.pdf

(43)

https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/decision_serious_crossborder_threats_22102013_en.pdf

(44)

https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/decision_serious_crossborder_threats_22102013_en.pdf

(45)

https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/decision_serious_crossborder_threats_22102013_en.pdf

(46)

  https://ec.europa.eu/health/preparedness_response/events/ev_20151012_en

(47)

  https://ec.europa.eu/health/tobacco/products/revision_en

(48)

  https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf

(49)

  https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2016.131.01.0048.01.ENG&toc=OJ:L:2016:131:TOC

(50)

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

(51)

  https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32010L0013

(52)

  https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ%3AJOL_2014_127_R_0001

(53)

  https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32003.0054

(54)

http://apps.who.int/iris/bitstream/handle/10665/42811/9241591013.pdf;jsessionid=2A5B92E5740040389E29FCC238FAD72E?sequence=1

(55)

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

(56)

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2016.101.01.0015.01.ENG&toc=OJ%3AL%3A2016 %3A101 %3ATOC

(57)

  https://ec.europa.eu/transparency/regdoc/rep/1/2016/EN/1-2016-269-EN-F1-1.PDF

(58)

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

(59)

  https://publications.europa.eu/en/publication-detail/-/publication/fd1f05fc-6def-11e8-9483-01aa75ed71a1/language-en?WT.mc_id=Selectedpublications&WT.ria_c=19980&WT.ria_f=3170&WT.ria_ev=search

(60)

  https://publications.europa.eu/en/publication-detail/-/publication/13b6f22d-75e4-11e8-ac6a-01aa75ed71a1/language-en?WT.mc_id=Selectedpublications&WT.ria_c=19980&WT.ria_f=3170&WT.ria_ev=search

(61)

  http://ec.europa.eu/chafea/health/bookshelf/infosheets/index_en.htm

(62)

  https://ec.europa.eu/health/scientific_committees/docs/call_2015_5383_decision_with_annexes_en.pdf

(63)

  https://ec.europa.eu/health/scientific_committees/consumer_safety_en

(64)

From April 2016 (the start of the Scientific Committee's new term) to December 2016.

(65)

  https://ec.europa.eu/health/sites/health/files/scientific_committees/scheer/docs/scheer_o_003.pdf

(66)

  https://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scenihr_consultation_29_en

(67)

  https://www.sciencedirect.com/science/article/pii/S0167779916300324

  https://www.sciencedirect.com/science/article/pii/S0273230016301970

  https://www.sciencedirect.com/science/article/pii/S0273230016300149

  https://www.sciencedirect.com/science/article/pii/S0273230015301501

  https://www.sciencedirect.com/science/article/pii/S0273230016300137

(68)

This includes travelling, accommodation, daily allowances and special indemnities. In 2016, travelling, accommodation and daily allowances were paid under the administrative budget (representing EUR 148 186.41) and special indemnities were paid under the health programme and the consumer programme (representing EUR 197 035).

(69)

  https://ec.europa.eu/health/expert_panel/sites/expertpanel/files/013_healthpolicyreforms_reformeffects_en.pdf

(70)

https://ec.europa.eu/health/expert_panel/sites/expertpanel/files/docsdir/014_publichealthsector_privateproviders_en.pdf

(71)

  https://ec.europa.eu/health/expert_panel/sites/expertpanel/files/016_memorandum_hospitalreforms_en.pdf

(72)

  https://ec.europa.eu/health/expert_panel/sites/expertpanel/files/015_access_healthservices_en.pdf

(73)

  https://ec.europa.eu/health/expert_panel/sites/expertpanel/files/015_access_healthservices_en.pdf

(74)

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

(75)

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

(76)

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

(77)

Commission Implementing Decision C (2014) 3383

(78)

OJ S 040-065407, 26.2.2014 and http://ec.europa.eu/CHAFEA/ami/ .

(79)

  http://ec.europa.eu/chafea/health/funding/calls-for-tenders/documents/grants-projects-awarded-2016_en_en.pdf

(80)

  http://ec.europa.eu/chafea/health/funding/calls-for-tenders/documents/operating-grants-awarded-2016_en_en.pdf

(81)

  http://ec.europa.eu/chafea/health/funding/calls-for-tenders/documents/grants-ern-awarded-2016_en_en.pdf .

(82)

   The framework contract (FWC) of a value of EUR 2 071 900 was signed. No specific contract has been committed under this FWC in 2016.