The Commission presents the report on the implementation of the 2016 annual work programme (2016 AWP), under the third Health Programme 2014-2020 established by Regulation (EU) No 282/2014 of the European Parliament and of the Council.

It provides detailed information on the 2016 budget and how it was used.

Themes

The priority health initiative under the 2016 AWP was to set up the European Reference Networks (ERNs) in accordance with: (a) Directive 2011/24/EU of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare; and (b) the EU policy on rare diseases.

ERNs are virtual networks involving more than 900 healthcare providers across the EU. They aim to tackle complex or rare diseases and conditions that require highly specialised treatment and a concentration of knowledge and resources.

Several financing measures were used to support ERNs in 2016, amounting to more than EUR 8 million (EUR 8 012 343.47). These included:

- a call of interest for ERNs;

- requests for service for the independent assessment bodies to assess candidate ERNs;

- a call to fund the coordination costs of the approved networks (EUR 4 386 344.15);

- a call in support of rare disease patient registries for the ERNs (EUR 1 979 361.05).

Budget implementation

The overall budget for the third health programme 2014-2020 is EUR 449.4 million. This includes EUR 30 million for the operating costs of the Consumer, Health, Food and Agriculture Executive Agency (Chafea), mandated by the Commission to manage the programme. Chafea has been providing the Commission with technical, scientific and administrative assistance in implementing the health programme since 2005. It organises annual calls for proposals, coordinates the evaluation of submissions, and negotiates, signs and manages related grant agreements, and disseminates results of the actions. It is also responsible for many procurement procedures.

The budget set out in the work plan for 2016 AWP was EUR 62 160 000, broken down as follows:

- operational expenditure: EUR 56 451 000, corresponding to the third EU health programme (2014-2020);

- administrative expenditure: EUR 1 500 000, corresponding to the expenditure to support the third EU health programme (2014-2020);

- contribution of the health programme to Chafea's budget: EUR 4 209 000.

The total operational budget came to EUR 57 992 112 as it included an additional EUR 1 541 112 of EFTA/EEA credits and recovery credits from previous budget years.

A total of EUR 56 695 888.83 was committed under the 2016 AWP: Chafea covered EUR 48 248 609.99 of this amount, while DG SANTE committed an additional EUR 8 447 278.84 covering part of procurement and other actions.

Objectives, priorities and financing mechanisms in 2016

In 2016, the total operational budget committed (EUR 56 695 888.83) was divided among the programme's four specific objectives as follows:

1. Health promotion: EUR 25 622 317.07 (45% of the operational budget in 2016) for promoting health, preventing diseases and fostering supportive environments for healthy lifestyles taking into account the ‘health in all policies’ principle 2. Health threats: EUR 3 947 709.3 (7%) for protecting EU citizens from serious cross-border health threats.

3. Health systems: EUR 8 655 656.8 (15%) for contributing to innovative, efficient and sustainable health systems.

4. Better and safer healthcare: EUR 14 892 153.25 (26%) for facilitating access to better and safer healthcare for EU citizens

Future developments

Following the work done in 2015, Chafea continued to invest significantly in information and dissemination activities in close collaboration with DG SANTE and the health programme's network of National Focal Points. Chafea organised several workshops, collaborated in major national and international conferences, and organised stand-alone events with national authorities in EU countries. It also produced a series of brochures and info-sheets on the health programme's key priority areas.

As most actions are still in their early stages, concrete results are not yet available. Deeper insights into the programme's overall impact will only be available once the first generation of co-funded actions has been completed. Nevertheless, the multiannual plan developed at the outset of the third health programme ensures continuity and coherence between the different types of financing instruments available.

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, which ended in late 2015 and in 2016, and which were in some cases followed up by actions even larger in scope and ambition.

Key actions co-funded under the second and third health programmes for which final results became available in 2016

These include, inter alia :

- joint action on rare diseases;

- joint action on a cross-border patient registries initiative;

- joint action on quality assurance exercises and networking on the detection of highly infectious pathogens;

- joint action on efficient response to highly dangerous and emerging pathogens at EU level;

- joint action on improving quality in HIV prevention.

The document also includes actions on the main 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.

The Commission presents the report on the implementation of the 2015 annual work programme (2015 AWP), under the third Health Programme 2014-2020 established by Regulation (EU) No 282/2014 of the European Parliament and of the Council.

It provides detailed information on the 2015 budget and how it was committed. It also takes account of the amendment to the 2015 AWP to channel funding towards those Member States under particular migratory pressure that require support in their response to the related health challenges.

Themes

The 2015 AWP focused on innovation in health and healthcare, with two related action streams (health technology and migrants’ health) highlighted in this report. The Commission decided to amend the 2015 AWP in response to the high influx of migrants in clear need of international protection and the need to provide financial support to organisations able to support Member States in addressing this emergency situation.

The priority health topic for the 2015 AWP was ‘health technology assessment (HTA) and innovation’. This was addressed through several actions funded by different financing mechanisms and signed in the first quarter of 2016, most of them for 3 years, meaning that they will run until the end of 2018 and in some cases until 2020.

They are:

- the new joint action on HTA, representing the highest ever EU contribution (EUR 11 999 798.74) to a single aspect of health policy under the third Health Programme;

- two projects and a joint action on integrated care (total EU contribution EUR 6 837 798.31);

- the preparatory work for the establishment of the European Reference Networks (EUR 381 372.23).

Budget implementation

The overall budget for the third Health Programme 2014-2020 is EUR 449.4 million. This includes EUR 30 million for the functioning of the Consumer, Health, Food and Agriculture Executive Agency (Chafea) which the Commission has mandated to manage the Health Programme 2014-2020. Chafea has been providing the Commission with technical, scientific and administrative assistance in implementing the Health Programme since 2005. It organises annual calls for proposals, coordinates the evaluation of submissions, negotiates, signs and manages related grant agreements, and disseminates the results of actions. It is also responsible for many procurement procedures.

The budget set out in the work plan for the 2015 AWP was EUR 59 750 000, broken down as follows:

- operational expenditure : EUR 54 041 000, corresponding to the third programme for EU action in the field of health (2014-2020) budget line 17 03 01 (‘Encouraging innovation in health, increasing the sustainability of health systems and protecting Union citizens from serious cross-border health threats’);

- administrative expenditure : EUR 1 500 000, corresponding to the support expenditure for the third Programme for EU action in the field of health (2014-2020) budget line 17 01 04 02.

The total operational budget was EUR 55 629 805 and the total administrative budget was EUR 1 551 822.66. This included EFTA/EEA credits and recovery credits from previous budget years.

Objectives, priorities and financing mechanisms in 2015

In 2015, the total operational budget was divided among the four specific programme objectives as follows.

1. Health promotion : EUR 15 669 170.92 (29 % of the operational budget in 2015) for promoting health, preventing diseases and fostering supportive environments for healthy lifestyles taking into account the ‘health in all policies’ principle.

2. Health threats : EUR 5 016 028.59 (9 % of the operational budget in 2015) for protecting EU citizens from serious cross-border health threats.

3. Health systems : EUR 25 106 924.35 (46 % of the operational budget in 2015) for contributing to innovative, efficient and sustainable health systems.

4. Better and safer healthcare : EUR 6 127 923.17 (11 % of the operational budget in 2015) for helping EU citizens access better and safer healthcare.

Other salient features

- 2015 was the second year of the third Health Programme that was seriously affected by the pressure caused by the unprecedented influx of refugees entering Europe;

- the number of participants involved in joint actions continued to be relatively high, as was the case for the second Health Programme and first year of the third Health Programme. There were between 10 and 45 partners (beneficiaries) per joint action. This high number was a challenge for the Programme’s overall management and coordination, as all partners had to sign the grant agreement;

- electronic monitoring and reporting has been introduced to save time on both sides however further improvements are to be introduced in the coming years, including an improved electronic monitoring and reporting system and better and more targeted dissemination.

The Commission report presents the main conclusions of the mid-term evaluation of the 3rd Health programme 2014-2020 under Regulation (EU) No 282/2014 on the establishment of a third programme of Union action in the field of health (2014-2020). It also presents ideas for improving the implementation of the programme for the remaining programming period (2018 – 2020).

The mid-term evaluation conducted in 2016-2017 - based on an external study and open public consultation - focused on the relevance of the thematic priorities, the achievement of the objectives and the effectiveness of the Programme’s management. However, it also touched upon other issues such as the efficient use of resources, the programme’s EU-added value and its internal and external coherence.

Results and achievements : the mid-term evaluation was positive and found that implementation of the programme is on track.

1) Health promotion and disease prevention : the Programme has supported cooperation among Member States through the generation, use, sharing and exchange of knowledge and best practices thus contributing to the achievement of SDG 3 to "ensure healthy lives and promote well-being for all at all ages".

The Commission, jointly with the OECD and the European Observatory on Health Systems and Policies, is bringing together expertise in the State of Health in the EU cycle to strengthen country-specific and EU-wide knowledge in health, supporting Member States in their evidence-based policy making. The perspective is to create a sustainable and integrated EU health information system.

Exchange of best practice has also been at the heart of several co-funded actions, in areas as diverse as HIV/AIDS and tuberculosis or the reduction of alcohol-related harm.

2) Crisis preparedness and management : activities to support capacity building against health threats have helped to avoid duplication and improve capabilities, delivering added value for the EU. During the Ebola and Zika virus outbreaks, the programme was used to support EU-funded activities to limit the spread of these threats.

Examples of further action include implementing the joint procurement of vaccines and medical counter-measures and improving the capacity of laboratories to rapidly detect new or emerging risks and ensure uniform standards of testing.

3) Innovation in health systems : the programme works in synergy with other EU programmes and policy areas to increase the efficiency of EU expenditure and maximise its impact. The joint action to support the eHealth network promotes digital services infrastructure in the public health sector. Collaboration among EU health technology assessment bodies has resulted in common tools and standards, providing opportunities for substantial economies of scale.

4) Access to better and safer healthcare : 24 European Reference Networks for rare diseases have been established to unite the expertise of more than 300 healthcare providers and 900 centres of expertise across Europe and make it available to rare disease patients. The programme also plays a crucial role in addressing Antimicrobial Resistance (AMR).

The main lessons learned are:

all thematic priorities remain valid and most actions deliver useful outcomes with high EU-added value , in particular for crisis management and for the safety and security in Europe; the Programme is in line with the needs of the Member States : the defined objectives are clear, explicit and specific, and the actions financed in the first three years are relevant; programme management has been made more efficient by better defining the types of objectives expected and providing indicators to measure progress; the Programme demonstrated its responsiveness and flexibility in the face of emerging needs such as the refugees’ crisis in summer 2015, which made a significant contribution to the Commission’s migration policy. Overall, action on migrants and refugees represents a public health investment of EUR 14.4 million; efficiency is being improved : broader thematic areas like health promotion and health systems were identified as priorities by Member States’ representatives in e-surveys and by a large number of health stakeholders in the public consultation and received the highest amount of funding. The programme introduced simplification measures concerning rules and procedures; the open public consultation attracted the attention of a broad selection of interested parties and provided strong support for continued cooperation through the Programme, particularly in areas such as health promotion, disease prevention and eHealth .

Improvements to be made : following the ex-post evaluation of the second Health Programme, the Commission undertook to work on three main aspects of the third Health Programme, as stated in its report to the European Parliament and the Council in May 2016: These commitments were to:

improve monitoring, reporting and dissemination efforts ; encourage participation of all Member States and other participating countries, and to work with all Member States, particularly those with greater public health needs; and develop synergies with the Commission’s main priorities and other programmes.

Moreover, and as suggested in the mid-term evaluation, the programme should remain focused on issues where EU added value can be achieved . These areas fall mainly under the objectives of protecting against cross-border health threats and the access to better and safer healthcare.

This European Commission report to the European Parliament and the Council concerns the implementation of the 3rd EU action programme in the field of health in 2014.

Objective of the report: the report provides an assessment of the implementation of the Union's action programme in the field of health in order to meet the requirements of Article 13 of the Regulation which lays down the requirement for the report. Its main purpose is to provide information on how the programme’s budget was used in 2014.

It is accompanied by a Commission staff working document which provides several examples of the main actions financed under the 2014 work programme in ancillary areas such as evaluation and dissemination.

As a reminder, the 3rd programme had a total budget of EUR 449.4 million and had 4 specific objectives to:

1. promote health, prevent disease and work towards the creation of conditions conducive to healthy lifestyles, taking into account the principle of integrating health issues into all policies;

2. protect EU citizens from serious cross-border threats to health;

3. contribute to innovative, effective and sustainable health systems;

4. improving access to better and safer healthcare for EU citizens.

Key findings: 2014 was the first year of the third programme, and its implementation was delayed. Thus, most grant agreements and several service contracts were signed only in the first quarter of 2015.

There has been progress in the execution of the programme, such as on-line submissions through the Participants Portal , on-line evaluation and the electronic signing of grant agreements. The Regulation also introduces simplified administrative procedures and direct grant agreements for joint actions, as well as partnership framework agreements, so that operating grant holders can carry out longer-term planning.

The new procedure for joint actions is also more transparent, since the consortium must first be constituted by designations by the Member States and the countries participating in the third programme. This means, however, that EU umbrella non-governmental organisations in particular, face the challenge of being nominated, whereas during the second programme they were nominated by the Commission.

The number of participants in joint actions remains relatively high, as was the case during the 2nd programme: 12 to 39 participants per joint action in 2014 , with an average of 25 participants.

This is a challenge for the overall management and coordination of joint actions . The outcome of the calls for proposals for projects shows that 2 calls ended with no project awarded. In one case, no applications were received, perhaps because the theme had been narrowly defined and the proposed co-financing was relatively low. In the second case, several proposals were received, but all were excluded during the evaluation process due to insufficient quality.

Outlook: In line with the recommendations of the ex-post evaluation, improvements should be made in the coming years , including:

· improved electronic tracking and reporting system,

· improved and better targeted dissemination and

· sustained work to involve organisations and institutions from countries that have so far been under-represented among beneficiaries.

PURPOSE: to establish a third Programme for the Union's action in the field of health for the period 2014-2020.

LEGISLATIVE ACT: Regulation (EU) No 282/2014 of the European Parliament and of the Council on the establishment of a third Programme for the Union's action in the field of health for the period 2014-2020.

CONTENT: in the framework of the new programme period 2014-2020, the European Parliament and the Council have established a third Programme for the Union's action in the field of health.

General objectives : the Programme shall have the general objectives to complement and support the policies of the Member States to improve the health of Union citizens and reduce health inequalities, by:

· promoting health,

· encouraging innovation in health,

· increasing the sustainability of health systems

· protecting Union citizens from serious cross-border health threats, as well as adding value to these policies.

Programme actions : the actions would be intended to:

1. promote health, prevent diseases, and foster supportive environments for healthy lifestyles (census of good practices): the realisation of this objective shall be measured through the increase in the number of Member States involved in health promotion and disease prevention, using evidence-based and good practices through measures and actions taken at the appropriate level in Member States ;

2. protect Union citizens from serious cross-border health threats (the development of coherent approaches for better preparedness and coordination in health emergencies in particular): the realisation of this objective shall be measured through the increase in the number of Member States integrating coherent approaches in the design of their preparedness plans;

3. support public health capacity-building and contribute to innovative, efficient and sustainable health systems (developing tools, at Union level, to address shortages of resources, and to facilitate the voluntary uptake of innovations in public health intervention): the realisation of this objective shall be measured through the increase in the advice produced and the number of Member States using the tools and mechanisms identified;

4. facilitate access to better and safer healthcare for Union citizens by increasing access, beyond national borders, to medical expertise and information for specific conditions: the realisation of this objective shall be measured through the increase in the number of European reference networks and centres of expertise joining European reference networks.

These actions should conform to the thematic priorities listed in the Regulation Annex and established within the framework of the annula work programmes.

Financial envelope : the financial envelope for the implementation of the Programme for the period from 1 January 2014 to 31 December 2020 shall be EUR 449 394 000 in current prices.

Types of interventions : the Regulation lists the types of intervention possible under the programme. It is particularly foreseen that for the actions having a clear Union added value and co-financed by the competent authorities that are responsible for health in the Member States or in the third countries, detailed rules for intervention are planned, if the actions have a character of exceptional utility . Exceptional utility is achieved where at least 30 % of the budget of the proposed action is allocated to Member States whose GNI per inhabitant is less than 90 % of the Union average, with at least 14 countries participating in the said action. It should be noted that g rants paid by the Union should not exceed 60 % of eligible costs for an action relating to an objective of the Programme or for the functioning of a non-governmental body. In cases of exceptional utility, the contribution by the Union may be up to 80 % of eligible costs.

Annual work programmes : the Commission shall be responsible for implementing the Programme and establishing annual work programmes by means of implementing acts. The annual work programmes shall set out the actions to be undertaken, including the indicative allocation of financial resources.

Administrative and technical assistance : the financial envelope for the Programme may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities required directly for the management of the Programme and the achievement of its objectives..

Participation of third countries : the programme is open to the participation of third countries subject to the terms outlined in the Regulation.

Methods of implementation : the Commission shall be responsible for the implementation of the Programme. It will deliver the Programme by means of annual work programmes which set out the actions to be undertaken, including the indicative allocation of financial resources.

Consistency and complementarity with other policies : the Commission shall, in cooperation with the Member States, ensure overall consistency and complementarity between the Programme and other policies, instruments and actions of the Union.

Monitoring, evaluation and dissemination of results : the conventional methods of control, monitoring, evaluation, dissemination of results and anti-fraud measures are set out in the Regulation.

The Commission should, in close cooperation with the Member States, monitor the implementation of the actions under the Programme in the light of its objectives and indicators, and shall keep the European Parliament and the Council informed.

Mid-term evaluation report : half way through the duration of the Programme, but not later than 30 June 2017 , the Commission shall draw up and present to the European Parliament and to the Council a mid-term evaluation report on the achievement of the objectives of the Programme. The mid-term evaluation report shall, additionally, address the scope for simplification, the internal and external coherence of the Programme, as well as the continued relevance of all objectives.

Where the mid-term evaluation report identifies that one or more thematic priorities cannot be implemented and achieved in line with the objectives of the Programme and within the duration of the Programme, the Commission shall be empowered to adopt, by 31 August 2017, delegated acts in accordance with Article 18 in order to remove the thematic priority concerned or to add new ones.

Annexes : Annex I provides thematic priorities for the implementation of the programme; and Annex II details the criteria for the preparation of the annual work programmes.

Repeal : Decision No 1350/2007/EC shall be repealed with effect from 1 January 2014 .

ENTRY INTO FORCE: 22.03.2014. The Regulation shall apply from 1 January 2014 .

DELEGATED ACTS: the Commission may adopt delegated acts with regard to the adaptation of the Programme following the conclusions of the mid-term evaluation report . The European Parliament or the Council may raise objections in regard to a delegated act within two months of notification of that act (this period may be extended by two months). If the European Parliament or the Council make objections, the delegated act will not enter into force.

The European Parliament adopted by 576 votes to 33 with 39 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council establishing a Health for Growth Programme, the third multi-annual programme of EU action in the field of health for the period 2014-2020.

Parliament adopted its position in first reading following the ordinary legislative procedure. The amendments adopted in plenary are the result of a compromise agreement between Parliament and Council. They amend the proposal as follows:

Title: the title of the programme has been amended so as to delete the words ‘health for growth’ and insert in its place a third Programme for the Union's action in the field of health (2014-2020). The new regulation will repeal Decision No 1350/2007/EC.

General objectives : it is specified that the general objectives of the Programme shall be to complement, support to the policies of the Member States to improve the health of Union citizens and reduce health inequalities by:

· encouraging innovation in health,

· increasing the sustainability of health systems and

· protecting Union citizens from serious cross-border health threats,

as well as add value to the policies of the Member States.

Programme actions : actions have been redefined. These must now be aimed at:

· health promotion and disease prevention and fostering supportive environments for healthy lifestyles (exchange of good practice ): this objective shall be measured, in particular, through the increase in the number of Member States involved in health promotion and disease prevention, using evidence-based and good practices through measures and actions taken at the appropriate level in Member States;

· protecting Union citizens from serious cross-border health threats by developing coherent approaches for better preparedness and coordination in health emergencies. This objective shall be measured through the increase in the number of Member States integrating coherent approaches in the design of their preparedness plans;

· supporting public health capacity-building and contribute to innovative, efficient and sustainable health systems by developing tools at Union level to address shortages of resources, both human and financial, and facilitate the voluntary uptake of innovations in public health intervention. This objective shall be measured, through the increase in the advice produced and the number of Member States using the tools and mechanisms identified;

· facilitating access to better and safer healthcare for Union citizens by increasing access to medical expertise, facilitate the application of the results of research and develop tools for the improvement of healthcare quality and patient safety through, actions contributing to the improvement of health literacy. This objective shall be measured, in particular, through the increase in the number of healthcare providers and centres of expertise joining European reference networks,

The specific objectives shall be achieved through actions in line with the thematic priorities listed in Annex I and implemented via the annual work programmes.

Funding: the financial envelope for the implementation of the Programme for the period from 1 January 2014 to 31 December 2020 shall be EUR 449 394 000 in current prices.

Types of intervention : this shall take the form of grants, public procurement or any other form of intervention necessary for achieving the objectives of the Programme. Grants may be awarded to fund actions having a clear Union added value co-financed by the competent authorities that are responsible for health in the Member States or in the third countries participating in the Programme if exceptional utility is achieved. This will be the case where at least 30 % of the budget of the proposed action is allocated to Member States whose GNI per inhabitant is less than 90 % of the Union average; and bodies from at least 14 participating countries participate in the action, out of which at least four are countries whose GNI per inhabitant is less than 90 % of the Union average.

Annual work programmes : the Commission shall implement the Programme by establishing annual work programmes adopted by means of implementing acts. These annual work programmes which shall set out, in particular, actions to be undertaken, including the indicative allocation of financial resources.

Mid-term evaluation : half way through the duration of the Programme, but not later than 30 June 2017, the Commission shall draw up and a mid-term evaluation report on the achievement of the objectives of the Programme. The report shall, additionally, address the scope for simplification, the internal and external coherence of the Programme, and the continued relevance of all objectives.

Where the mid-term evaluation report identifies that one or more thematic priorities cannot be implemented and achieved in line with the objectives of the Programme and within the duration of the Programme, the Commission shall be empowered to adopt, by 31 August 2017, delegated acts in order to remove the thematic priority or priorities concerned from Annex I or add new thematic priorities.

Annexes: Annex I has been amended to put in new thematic priorities mentioned in the text. A new Annex II sets out the criteria for establishing annual work programmes.

The Committee on the Environment, Public Health and Food Safety adopted the report by Françoise GROSSETÊTE (EPP, FR) on the proposal for a regulation of the European Parliament and of the Council establishing a Health for Growth Programme, the third multi-annual programme of EU action in the field of health for the period 2014-2020.

The committee recommended that the European Parliament’s position adopted in first reading, following the ordinary legislative procedure, should amend the Commission proposal as follows:

Title : Members propose changing the title of the programme to “Health and Growth for Citizens Programme” instead of “Health for Growth Programme.

General objectives : the Programme should respect the competences of Member States in the field of health and their freedom to decide what kind of health services they consider it appropriate to provide, in strict compliance with the principle of subsidiarity. The general objectives of the Programme shall be to complement, support and add value to the policies of the Member States in order to improve physical and mental health and access to healthcare for all EU citizens and reduce health inequalities by addressing the health-related, social and economic challenges posed by an ageing population and the increasing number of chronic illnesses , by:

promoting health and the principle of prevention, encouraging innovation in healthcare, increasing the sustainability and the comparability of health systems, operating within a gender-sensitive framework, protecting EU citizens from serious crossborder health threats.

The objectives shall be achieved through the actions listed in the Annex.

Specific objectives : Members state that the general objectives shall be pursued through the following specific objectives:

develop common tools and mechanisms at EU level to address shortages or surplus of resources, both human and financial, and to facilitate voluntary up-take of innovation in public health interventions, prevention strategies and healthcare management, in order to contribute to innovative, efficient and sustainable health systems; increase access to medical expertise and information for specific conditions also beyond national borders, develop shared solutions and guidelines, promote research and comparisons between national health systems to improve health literacy; identify, disseminate and promote the up-take of validated best practices for cost-effective prevention measures by addressing the key risk factors, namely smoking, harmful use of alcohol, an unhealthy diet, a sedentary lifestyle and obesity, drug use and environmental factors, as well as communicable diseases , with a focus on the cross border dimension, and operating in a gender-sensitive framework; contribute to evidence-based decision making by fostering health information, collecting and analysing harmonised health data and disseminating key health indicators .

Financial envelope : in the report, Members point out that the financial envelope specified in the legislative proposal constitutes only an indication to the legislative authority and cannot be fixed until agreement is reached on the proposal for a regulation laying down the multiannual financial framework for the years 2014-2020. They stress that the amounts of funding referred to in this legislative procedure may have to be adapted to suit the financial envelope of the Health for Growth Programme in the ongoing negotiations on the multi-annual financial framework. They reiterate that sufficient additional resources are needed in the next MFF in order to enable the Union to fulfil its existing policy priorities and the new tasks provided for in the Treaty of Lisbon. Members point out that even with an increase in the level of resources for the next MFF of at least 5% compared to the 2013 level only a limited contribution can be made to the achievement of the Union’s agreed objectives and commitments .

Members note that budgetary resources should be shared out between objectives in a manner proportionate to their probable advantages for EU citizens’ health. There should not, therefore, be a set order of priority for objectives.

Delegated acts : in order to implement the Programme, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of drawing up annual work programmes . As the annual work programme contains elements that are significant policy choices intended to supplement or amend the primary policy shaping elements as established in this Regulation, it is suitable to delegate powers to the Commission in this respect.

Consistency and complementarity : the Commission shall, in cooperation with the Member States, ensure overall consistency and complementarity between the Programme and other policies, instruments and actions of the Union and the activities of agencies whose remit is covered by the Programme.

Key indicators : the Commission should annually monitor the implementation of the programme using key indicators for assessing results and impacts . The indicators, should provide the basis for assessing the extent to which the objectives of the programme have been achieved.

Report : Members suggest that Member States shall report every two years on the measures undertaken and the resources spent on actions under the Programme, including, in particular, networking activities, exchange of best practices and expertise across borders. The Commission shall make the results publicly available and shall ensure they are widely disseminated.

Annex : the annex details the eligible actions, such as:

innovation : f ostering innovation in the field of public health interventions, prevention strategies, health system management and organisation and provision of care, has the potential to improve public health outcomes. Member call for innovative measures to be supported such as health innovation and e-Health : use of intelligent transport systems ( ITS ) by emergency medical services; mental health : a ccording to the WHO, one in four Europeans will have a mental health issue at some time in their lives. Mental health problems are also wide-ranging, long-lasting and a source of discrimination, contributing significantly to inequality in health in the Union. Members call for innovative solutions in the treatment of neurodegenerative diseases ; prevention : Members consider that p revention needs to be looked at in its entirety, including primary, secondary and tertiary prevention, in order to stop a disease getting to its final stage. Prevention means primary prevention, including health promotion policies, as well as secondary prevention, including vaccination programmes , early diagnosis and appropriate treatment in order to prevent the development of a disease, as well as tertiary prevention, including methods to mitigate and reduce the complications of a disease. The aim is to identify, disseminate and promote the up-take of validated best practices for cost-effective prevention measures by addressing the key risk factors, namely smoking, harmful use of alcohol, an unhealthy diet, a sedentary lifestyle and obesity, drug use and environmental factors, as well as communicable diseases; synergies : Members consider that this p rogramme should also contribute to creating synergies with the European research field by introducing and applying innovative breakthroughs in the health sector and making sure that limited national European resources are used efficiently; gender dimension, notably in terms of data collection : the report notes that m ajor gaps still exist in expertise and general knowledge about the differences between disease processes in women and men, and further gendersensitive studies, analyses, investigations and sex-disaggregated data would contribute to identifying, disseminating and promoting validated best practices for cost-effective prevention measures addressing gender-specific health conditions and diseases; health education : studies show that the Union is lagging far behind many countries in the world as regards health education and patient awareness of safety and quality issues. Members consider it essential to focus more closely on improving EU citizens’ health education and raising awareness among patients and healthcare professionals of safety and quality issues; rare diseases : Members call for support for European cooperation, networking and information in the field of rare diseases as well as emerging rare diseases; resistance to medicine : Members state that the prudent use of antimicrobial agents in medicinal products in both human medicine and veterinary medicine should be improved and that there should be a reduction in the practices that increase antimicrobial resistance, including in the veterinary sector, particularly in hospitals; combat inequality : the programme should develop comparable Union-wide health indicators in order to help reduce inequalities as regards healthcare in the Union; environmental impact on health : according to the WHO, in the WHO European region more than 1.7 million deaths (18% of the total) each year can be ascribed to environmental factors. In this respect, Members call for the exchange knowledge and best practice on the environmental impacts on health; public health threats : t o minimise the public health consequences of cross-border health threats which could range from mass contamination caused by chemical incidents to pandemics, like those unleashed recently by E coli, influenza strain H1N1 or SARS (severe acute respiratory syndrome) or diseases from developing countries which through global population movements are an increasing reality in some European countries, the Programme should contribute to the creation and maintenance of rob ust mechanisms and tools to detect, assess and manage major cross-border health threats. The EU should be more proactive in implementing its Europe-wide vaccination strategies by ensuring optimal vaccination cover .

The Council agreed a partial general approach on the third multi-annual EU programme in the field of health for the period 2014-2020.

The programme aims to encourage innovation in healthcare and increase the sustainability of health systems, to improve the health of EU citizens and protect them from cross-border health threats.

These general objectives will be pursued through actions grouped under four specific objectives:

(1) innovative and sustainable health systems,

(2) increased access to better and safer healthcare,

(3) prevention of diseases and promotion of good health and

(4) protection from cross-border health threats.

The general approach is partial since the budget to be made available for the next EU public health programme will depend on the outcome of the negotiations on the next multiannual framework. The Commission proposed to support the new programme with an amount of EUR 446 million.

The Commission reserves its position on the entire compromise proposal. It particularly highlighted its fundamental disagreement on:

the change of the Title; the reordering of the objectives; the procedure on how to adopt the work programme; the introduction of a no-opinion clause and the footnote regarding drug prevention.

PURPOSE: to establish a Health for Growth, the third multi-annual programme of EU action in the field of health for the period 2014-2020.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

BACKGROUND: the healthcare sector is one of the largest in the EU: it accounts for approximately 10% of the EU’s gross domestic product and employs one in ten workers, with a higher than average proportion of workers with tertiary-level education. Health therefore plays an important role in the Europe 2020 agenda .

As underlined in its Communication of 29 June 2011 entitled “ A budget for Europe 2020 ”, this third programme of EU action in the field of health (2014-2020), ‘Health for Growth’, strengthens and emphasises the links between economic growth and a healthy population to a greater extent than the previous programmes. The Programme is geared towards actions with clear EU added value .

The general objectives of the Health for Growth Programme shall be to work with Member States to:

encourage innovation in healthcare, increase the sustainability of health systems, and improve the health of the EU citizens and protect them from cross-border health threats.

IMPACT ASSESSMENT: the impact assessment looked at different options for the programme and their expected impact:

Option 1 : minimal action: this option corresponds to the absolute minimum of actions resulting from the legal obligations imposed by the Treaty and the existing EU acquis in the field of medicinal products, medical devices, substances of human origin, patients rights in cross border healthcare, Health security (cross border health threats) and tobacco. Option 2 : baseline scenario: this option implies continuing the programme in its present form with no changes consequently to the findings of the evaluations, in addition to the direct legal obligations.

· Option 3, sub-option A : this option corresponds to a well structured programme, with SMART objectives, prioritised actions, creating EU added value and with better monitoring of outcomes and impacts. It will be focused on: i) supporting actions required by the current EU health and internal market legislation, ii) supporting the up-take of innovative solutions for improving specific points concerning the quality, efficiency and sustainability of health systems, iii) prevention of diseases at EU level by helping and complementing Member States’ efforts to increase their citizens’ number of healthy life years (HLY), including the aspect of reduction of health inequalities but mainly by other means than the resources of the Programme and limited to development of working methods and policy evaluation; iv) supporting and complementing Member States efforts in protecting citizens from cross-border health threats.

· Sub-option 3, sub-option B: this option corresponds to a well structured programme but dealing only with one of the general objectives as a trade off. This programme would be focused on: i) supporting actions required by the current EU health and internal market legislation, ii) supporting the up-take of innovative solutions for improving specific points concerning the quality, efficiency and sustainability of health, iii) supporting and complementing Member States efforts in protecting citizens from cross-border health threats.

· Sub-option 3, sub-option C: this option corresponds to a programme limited to supporting actions required by the current EU health related legislation and to supporting solutions for cross border health threats. In addition, there would be some dissemination of the results of the current Health Programme (2008–2013) in order to take into account the conclusions of previous evaluations.

Option 4: this corresponds to a well-structured programme focusing on the same issues as option 3 A but adding a specific objective for addressing wider, social and economic, causes of health inequalities by appropriate financial means. This option would imply a significant increase of the envelope for the Programme.

Following analysis of the results, Option 3A is the preferred option .

LEGAL BASIS: Article 168 (5) of the Treaty on the Functioning of the European Union (TFEU).

CONTENT: the general objectives of the Health for Growth Programme shall be to work with Member States to encourage innovation in healthcare and increase the sustainability of health systems, to improve the health of the EU citizens and protect them from cross-border health threats.

It focuses on four specific objectives with a strong potential for economic growth through better health:

1) to develop common tools and mechanisms at EU level to address shortages of resources, both human and financial and to facilitate up-take of innovation in healthcare in order to contribute to innovative and sustainable health systems ;

2) to increase access to medical expertise and information for specific conditions also beyond national borders and to develop shared solutions and guidelines to improve healthcare quality and patient safety in order to increase access to better and safer healthcare for EU citizens;

3) to identify, disseminate and promote the up-take of validated best practices for cost-effective prevention measures by addressing the key risk factors, namely smoking, abuse of alcohol and obesity, as well as HIV/AIDS, with a focus on the cross border dimension, in order to prevent diseases and promote good health; and

4) to develop common approaches and demonstrate their value for better preparedness and coordination in health emergencies in order to protect citizens from crossborder health threats.

Eligible actions: the proposal lays down the actions eligible under the programme. Actions that will be eligible will be those that:

Contribute to innovative and sustainable health systems : e.g. developing EU cooperation on Health Technology Assessment; promoting the uptake of health innovation and e-Health by increasing the interoperability of e-Health applications; supporting the European Innovation Partnership on Active and Healthy Ageing, a pilot project under Europe 2020 flagship initiative Innovation Union; fostering a health knowledge system,…

Increase access to better and safer healthcare for citizens : e.g. supporting action on rare diseases including creation of European Reference Networks; strengthening collaboration on patient safety and quality of healthcare, by increasing the availability of information to patients, exchanging of best practices and development of guidelines; developing guidelines to improve the prudent use of antimicrobials in human medicine and reducing the practices that increase antimicrobial resistance,…

Promote good health and preventing diseases : e.g. exchanging best practices on key health issues such as smoking prevention, abuse of alcohol and obesity; supporting the prevention of chronic diseases including cancer, by sharing knowledge and best practice and developing joint activities,…

Protect citizens from cross border health threats : e.g. strengthening preparedness and response for serious cross border health threats; supporting capacity building against health threats in Member States,…

A more detailed description of the content those actions may have is included in Annex I of the proposed Regulation.

Participation of third countries: the Programme shall be open on a cost basis, to the participation of third countries, in particular of:

· acceding countries, candidate countries and potential candidates benefiting from a pre-accession strategy,

· EFTA/EEA countries,

· neighbouring countries and the countries to which the European Neighbourhood Policy (ENP) applies,

· other countries in accordance with the conditions laid down by a relevant bilateral or multilateral agreement.

Types of intervention and participation: financial contributions by the Union may take the form of either grants or public procurement or any other interventions necessary for achieving the objectives of the Programme. The proposal describes the forms of intervention by type of action eligible. Overall; the design of the revised programme favours simplification of interventions:

· simplified rules,

· reducing the costs of participation,

· accelerating award procedures, and

· providing a "one-stop shop" to make it easier for beneficiaries to access EU funding.

Budget and rate of co-financing : the programme will have a budget of EUR 446 million from 2014-2020. The level of Union co-financing for grants for actions, actions co-financed by the competent authorities of the Member States or third countries, or by non-governmental bodies mandated by these authorities and operating grants will be harmonised at 60% of eligible costs and up to 80% in cases of exceptional utility .

Provisions are foreseen to define the rules regarding eligibility for grants for actions covered by the Programme. Grants may be awarded to legally established organisations, public authorities, public sector bodies, in particular research and health institutions, universities and higher education establishments and undertakings, in accordance with strictly defined criteria.

Administrative and technical assistance : the financial allocation for the Programme may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities required directly for the management of the Programme and the achievement of its objectives, in particular studies, meetings, information and communication actions, including corporate communication of the political priorities of the EU, as well as all other technical and administrative assistance expense incurred by the Commission for the management of the Programme.

Methods of implementation: the Commission shall be responsible for the implementation of the Programme by drawing up annual work programmes establishing the priorities and actions to be undertaken, as well as other detailed eligibility criteria for the beneficiaries. In order to ensure uniform conditions for the implementation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council .

Consistency and complementarity with other policies: the Commission shall, in cooperation with the Member States, ensure overall consistency and complementarity between the Programme and other policies, instruments and actions of the Union.

Monitoring, evaluation and dissemination of results: the usual methods of monitoring, evaluation, dissemination of results and combating fraud are foreseen in the proposal. The Commission shall, in close cooperation with the Member States, monitor the implementation of the actions under the programme in the light of its objectives and indicators and keep the European Parliament informed thereof.

Reporting : no later then mid-2018, an evaluation report shall be established by the Commission on the achievement of the objectives of all the measures (at the level of results and impacts), the efficiency of the use of resources and its European added value, in view of a decision on the renewal, modification or suspension of the measures. The longer-term impacts and the sustainability of effects of the Health for Growth Programme should be evaluated with a view to feeding into a decision on a possible renewal, modification or suspension of a subsequent programme.

It should be noted that the Member States shall designate National Focal Points which shall assist the Commission in the promotion of the Programme, the dissemination of its results and the information on its impacts in their respective countries.

Repeal: Decision No 1350/2007/EC shall be repealed with effect from 1 January 2014.

BUDGETARY IMPACT: the financial appropriations for implementing the programme over the period from 1 January 2014 to 31 December 2020 will amount to EUR 446 million (in current prices).