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# 52011PC0709

**Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a Health for Growth Programme, the third multi-annual programme of EU action in the field of health for the period 2014-2020 /\* COM/2011/0709 final - 2011/0339 (COD) \*/**

  

EXPLANATORY MEMORANDUM

1.
CONTEXT OF THE PROPOSAL

Health is not just a value in itself - it
is also a driver for growth. Only a healthy population can achieve its full
economic potential. The health sector is driven by innovation and a highly
qualified workforce. Health-related research and development has the potential
to reach 0.3% of GDP. 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. In its Communication of 29 June 2011 ‘A budget for
Europe 2020’[1]
the Commission stressed that ‘promoting good health is an integral part of
the smart and inclusive growth objectives for Europe 2020. Keeping people
healthy and active for longer has a positive impact on productivity and
competitiveness. Innovation in healthcare helps take up the challenge of
sustainability in the sector in the context of demographic change’, and
action to reduce inequalities in health is important to achieve ‘inclusive
growth’.

The proposed 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, in line with the Europe 2020 objectives and current
policy priorities.

The financial crisis has further
highlighted the need to improve the cost-effectiveness of health systems.
Member States are under pressure to strike the right balance between providing
universal access to high-quality health services and respecting budgetary
constraints. In this context, supporting Member States’ efforts to improve the sustainability
of their health systems is crucial to ensure their ability to provide high
quality healthcare to all their citizens now and in the future. The Health for
Growth Programme contributes to finding and applying innovative solutions for
improving the quality, efficiency and sustainability of health systems, putting
the emphasis on human capital and the exchange of good practices.

Key goals, set out in the
"Europe 2020 – A strategy for smart, sustainable and inclusive
growth"[2],
all hinge on increasing innovation in healthcare as reflected in flagship
initiatives such as the Innovation Union and the Digital Agenda. However, innovation is not just about technology and new products. It is also
about innovating in how healthcare is organised and structured, how resources
are used, how systems are financed.

As such, innovation in health has
the potential to help reduce healthcare costs and improve the quality of care. Many areas of the proposed Health for Growth Programme, such as
health technology assessment (HTA), medical devices, clinical trials and
medicinal products, as well as the European Innovation
Partnership on Active and Healthy Ageing, aim to
strengthen the link between technological innovation and its uptake and
commercialisation; while fostering security, quality and efficiency of
healthcare. Other initiatives focus on promoting the uptake and
interoperability of e-Health solutions, to improve for example cross-border use
of patient registers.

The Programme will further support better forecasting,
planning of needs and training of health professionals, which will contribute
to both organisational innovation and inclusive growth. This is in line with
the EU 2020 flagship initiative for New Skills and Jobs and its focus on
flexibility and security, equipping people with the right skills for the jobs
of today and tomorrow, better working conditions and improving job creation. As
the population ages and demand for healthcare grows, the health sector has
great potential to create new jobs.

Health problems are one of the major causes
of absenteeism from work and early retirement. Keeping people healthy and
active for longer has a positive impact on productivity and competitiveness.
Increasing the number of healthy life years is a
prerequisite if Europe is to succeed in employing 75 % of 20-64 year-olds
and avoiding early retirement due to illness. In addition, keeping people over
65 years of age healthy and active can impact on labour market participation
and lead to potential important savings in healthcare budgets.

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 cross-border health threats.

This proposed Regulation sets out the
general provisions governing the Health for Growth Programme and repeals
Decision (EC) No 1350/2007.

2.
OBJECTIVES

The challenges outlined above first and
foremost require Member States to take direct action at national level. The aim
of EU health policy, as stated in the Treaty, is to complement and support
these national policies and encourage cooperation between Member States. The
Programme provides possibilities to build and strengthen cooperation mechanisms
and coordination processes between Member States with a view to identifying
common tools and best practices that create synergies, bring EU added value and
lead to economies of scale, thus supporting reform under challenging
circumstances.

2.1.
Developing common tools and mechanisms at EU
level to address shortages of resources, both human and financial and
facilitating up-take of innovation in healthcare in order to contribute to
innovative and sustainable health systems

For many years, Member States have been
facing budget constraints with regard to the sustainability of their health
budgets, which represent up to 15% of public expenditure in some Member States[3].

This is further compounded by an ageing
population, rising expectations for high quality services and the emergence of
new, more effective but more expensive technologies. The challenges have
increased with curbs on public spending in the wake of the financial crisis. Evidence[4] suggests, however, that
effective health system reforms have the potential to contain ‘excess cost
growth’, i.e. keep health spending in line with GDP growth.

By supporting Member States’ efforts to
improve the efficiency and financial sustainability of health care, the
programme aims to encourage a significant shift of resources in this sector
towards the most innovative and valuable products and services, which at the
same time offer the best market potential and cost savings in the longer term. It
also seeks to support innovation in how healthcare is organised, to foster for
example a greater shift towards community care and integrated care. Health
system reform must clearly consist of a mix of immediate efficiency gains and
longer-term strategic action addressing key cost drivers. For example, European
cooperation on health technology assessment will not only reduce duplication
and pool expertise, but can also unlock the potential for sustainable
innovation in health products and services.

Health-related investments under the
Structural Funds can play a particularly important role in helping Member
States reform their health systems at national and regional level, and in
meeting the four specific objectives under this Programme, drawing from best
practice and pilot project experience acquired through the Health for Growth
Programme. As such, co-operation and synergies between the Health for Growth
programme and the Structural Funds will be reinforced.

With an ageing population and changing
family structures, the demand for formal, professionalized care is increasing
as the availability of informal care in the family environment is declining.
Healthcare has also become more specialised and requires more intense work and
longer training. By 2020 there will be a shortage of one million health workers
in the EU and, should no action be taken, 15% of necessary care will not be covered.
If successfully addressed, however, this would create significant employment
and growth opportunities.

To achieve this, the Programme will develop
common tools and mechanisms at EU level to help national health systems deliver
more care with fewer resources. Innovative solutions are needed to tackle
workforce shortages and to maximise the efficiency of health systems through
the use of innovative products, services, tools and models. Successful
implementation of such solutions will also require overcoming barriers such as public
procurement and lack of user involvement in innovation.

In this context, actions planned under this
objective aim for example to foster European cooperation on Health Technology
Assessment (HTA) and explore the potential of e-Health and ICT for Health,
including a dedicated e-Health network and cooperation among electronic patient
registries, as part of the implementation of the Directive on patients' rights in
cross border healthcare[5].
Actions will also address shortages in the health workforce and
assist Member States in reforming their health systems through the pooling and
strengthening of expertise on technical evaluation of policy action.

They will also support measures setting
high standards of safety, quality and efficacy for devices for medical use
required by or contributing to the objectives of EU legislation in this field,
as well as contributing to provisions on e-Health and HTA of the above
mentioned Directive.

The programme may also provide support,
under its different objectives, to specific actions under the European
Innovation Partnership on Active and Healthy Ageing in its three themes:
innovation in awareness, prevention and early diagnosis; innovation in cure and
care and innovation for active ageing and independent living.

2.2.
Increasing access to medical expertise and
information for specific conditions also beyond national borders and developing
shared solutions and guidelines to improve healthcare quality and patient
safety in order to increase access to better and safer healthcare for EU
citizens

Improving access to healthcare for all
citizens regardless of income, social status, location and nationality is key
to bridging the current substantial inequalities in health. All EU citizens
should have access to safe and high-quality healthcare regardless of their
circumstances. However, in reality, access to healthcare still varies
significantly in the EU. Poor health status often has a substantial impact on
accessibility to effective healthcare and the possibilities of citizens to act
on health information. People with low income, the socially excluded and those
living in depressed or micro regions can experience specific difficulties in
accessing healthcare. Action under all the objectives of the programme should
help contribute to bridging such inequalities by addressing various factors
that give rise to and increase inequalities, as well as complement action under
other programmes aimed at addressing social and regional differences within the
EU.

To improve access to healthcare, in
particular for specific conditions where national capacity is scarce, there is
clear added value in fostering the networking of specialised European centres
of reference accessible to all citizens across the EU.

In addition, to help Member States further
improve the quality and safety of healthcare, the programme will consolidate
and continue on-going action to identify, exchange and disseminate good
practices in this area. The programme will increase access to medical expertise
by supporting the establishment and setting up of a system of European
reference networks defining their criteria and conditions and by developing
shared solutions and guidelines for healthcare quality and patient safety across
the EU, tackling a range of issues including antimicrobial resistance.

Actions under this objective will also
support measures setting high standards of safety, quality and efficacy of
blood, organs, tissues and cells, of pharmaceutical products and patients'
rights in cross border health care required by or contributing to the
objectives of EU legislation in these fields.

2.3.
Identifying, disseminating and promoting 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

Life expectancy has been progressing over
the last decades in an unprecedented way and was 76.4 years for men and 82.4
years for women in the EU in 2008. By contrast, the average number of healthy
life years has been progressing at a much slower pace and was 60.9 years for
men and 62 years for women.

This means that a greater part of a longer
life is being spent in ill health, which is one of the factors driving
spiralling health costs and hampering participation in the labour market. Ill
health adversely affects the development of human capital, which is crucial for
developing a knowledge-based economy.

Chronic diseases are the main cause of
death and poor quality of life in Europe. Over 4 million people in the European
Union die every year because of chronic diseases, which represent 87% of premature
mortality in the EU. Chronic diseases also represent a huge economic burden
through loss of people’s capacity to work in the prime of their lives. The
programme includes action to support the efforts of Member States aimed at
prolonging the healthy and productive life years of their population by
preventing chronic diseases.

Many chronic diseases are preventable. They
are often the result of smoking, harmful alcohol consumption, poor diet and
insufficient physical activity. These risk factors are further compounded by
underlying socio-economic factors as well as environment factors.

This is not just a major health challenge,
but also a substantial economic opportunity. The right investments will lead
not only to better health, but also to longer and more productive lives and
lower labour shortages. If Europeans live in better health, they will be able
to continue contributing to the economy as they grow older, as workers,
volunteers and consumers. The expertise of the elderly will also be needed even
more in a population with low birth rates and a lack of skilled labour.

The programme will address the challenges
in these areas by fostering best practice in health promotion and
cost-effective prevention targeting key health determinants namely smoking,
abuse of alcohol and obesity, as well as HIV/AIDS, with a focus on cross border
issues. It will support European cooperation and networking on preventing
chronic diseases, including guidelines on quality cancer screening. Actions
under this objective will also support measures which have as their direct
objective the protection of public health regarding tobacco products and
advertisement required by or contributing to the objectives of EU legislation
in this field.

2.4.
Developing common approaches and demonstrating
their value for better preparedness and coordination in health emergencies in
order to protect citizens from cross-border health threats

In the recent past, the EU has faced several major cross-border
threats to health, such as pandemic influenza or SARS. EU
competence as regards coordinating preparedness for and response to serious
cross-border health threats is enshrined in the Lisbon Treaty. By their very
nature, such health threats are not confined to national borders and cannot be
effectively addressed by any Member State or by the Union alone. The EU needs
to be well prepared against these threats, which can have a heavy impact not
just on the health and life of citizens, but also on the economy.

Actions planned under this objective will
help develop common approaches to prepare for possible health emergencies, to
co-ordinate a response to such health emergencies at European level, and to
support national capacity building in preparedness and management of health
crises taking into account international initiatives. The aim is to support preparedness
planning, including for pandemic influenza, address gaps in risk assessment
capacities between Member States and support capacity building against health
threats in Member States as well as promoting the capacity at global level to
respond to health treats.

Actions will also support measures designed
to protect and improve human health against communicable diseases, major
cross-border health scourges, measures concerning monitoring, early warning of
and combating serious cross-border threats to health required by or
contributing to the objectives of EU legislation in these fields.

Under all four objectives mentioned above,
the Programme will support actions on Health information and knowledge to
contribute to evidence-based decision making, including collecting and
analysing health data and wide-ranging dissemination of the results of the
Programme. It will also support the activities of the
Scientific Committees set up in accordance with Commission Decision 2008/721/EC.

3.
RESULTS OF CONSULTATIONS WITH THE INTERESTED
PARTIES AND IMPACT ASSESSMENTS
3.1.
Consultation and expert advice

The consultation targeted in particular
Member States' representatives, National Focal Points, the Council working
party on Public health at Senior Level and the informal Health Council. Additional
expert advice was provided through the EU Health Policy Forum, health
professionals and patients associations. Other programme stakeholders,
especially beneficiaries, have expressed their views in the recent programme
evaluations.

All participants in the various
consultations strongly supported the Health Programme. Some Member States
concurred with the view that it should be more focused, cost-efficient and
based on action with proven EU added value, whereas others were of the opinion
that it should continue to support the existing objectives and a wide range of
actions.

National Focal Points designated by Member
States’ authorities mentioned that the programme could help to shape national
policies by (a) providing best practices, (b) sharing and exchanging practical
experience, expertise and knowledge and (c) giving support on health issues on
the national political agenda. The EU Health Policy Forum argued that strong
emphasis should be put on health determinants and a patient-centred focus. It also
recommended that the programme address the role of social determinants.

Furthermore, Member States and stakeholders
alike mentioned the need for more active participation in the programme by all
EU Member States and emphasised that the programme should be more closely
linked to the Treaty on the Functioning of the European Union, to the Europe
2020 agenda and to the existing legislation.

3.2.
Impact Assessment

The Impact Assessment report analysed
various options for the programme. It identified the preferred option, from a
cost/benefit point of view, as corresponding to a well structured programme,
with specific, measurable, attainable, relevant and
time-bound (SMART) objectives, prioritised actions, creating EU added value and
with better monitoring of outcomes and impacts. The programme will focus on:

·
contributing to facilitate the up-take of innovative
solutions for improving the quality, efficiency and sustainability of health
systems and increasing access to better and safer healthcare;

·
promoting good health and preventing diseases at
EU level by helping and complementing Member States’ efforts to increase their
citizens’ number of healthy life years;

·
supporting solutions for cross-border health
threats;

·
supporting actions required by the current EU legal
obligations.

The budget
under this option is approximately 57 million euro annually (in 2011 prices),
which is in line with the proposed budget allocation for the Health for Growth
Programme in the Communication ‘A Budget for Europe 2020’ of June 2011.

3.3.
Delivering European added value

As stated in Article 168 of the Treaty on
the Functioning of the European Union, EU action must complement national
policies and encourage cooperation between Member States. The programme should
contribute only where Member States can not act individually or where
coordination is the best way to move forward.

The programme puts forward actions in areas
where there is evidence of EU added-value on the basis of the following
criteria: fostering best practice exchange between Member States; supporting
networks for knowledge sharing or mutual learning; addressing cross-border
threats to reduce risks and mitigate their consequences; addressing certain
issues relating to the internal market where the EU has substantial legitimacy
to ensure high-quality solutions across Member States; unlocking the potential
of innovation in health; actions that could lead to a system for benchmarking;
improving economies of scale by avoiding waste due to duplication and
optimising the use of financial resources.

3.4.
Increasing the performance of the programme

The Programme builds on the results of the
first Public Health Programme (2003-2008) and the second Health Programme
(2008-2013), in line with the conclusions and recommendations made in the different
evaluations and audits performed on these programmes.

The new programme aims to focus on fewer
actions, of proven EU added value, that deliver concrete results, and respond
to identified needs or gaps. The programme seeks to
improve the way Member States cooperate in the area of health and to provide
leverage for reform of national health policies.

Activities over the seven years period and annual
work plans should be based on multi-annual programming of a limited number of
actions per year. In addition, building on lessons learnt and the results of
various evaluations, the programme introduces a number of new elements:

·
progress indicators to measure and monitor the
objectives and the impact of the programme;

·
EU added value as a key determinant in setting
the priorities for the annual work plans;

·
better dissemination and communication of the
results of the projects to policy makers;

·
incentives to encourage greater participation of
Member States with lower Gross National Income (GNI) in the programme. This
will include a higher co-financing rate for those Member States.

Simplification

The revision of the Financial Regulation
will contribute to facilitate participation in EU programmes, for example by
simplifying 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. The Programme will make a maximum use of
the provisions of the revised EU Financial Regulation, in particular by further
simplifying reporting requirements, including a more extensive use of online
reporting.

The design of the new programme involves simplifying its implementation and
management:

1. 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.

2. The long-term programming of strategic
actions under the programme will help reduce their overall number per year and
avoid repetitive work in application, evaluation, negotiation and contracting
procedures. In addition, this will allow greater focus on the priority areas and
better use of human and financial resources. The funding process will be
simplified in particular through the use of framework contracts for operating
grants, and the possibility of using lump sums will be examined whenever
possible so as to reduce the administrative burden.

3. The new monitoring and evaluation
indicators rely on effective dissemination of Programme results and will trace
their use in Member States with the assistance of the National Focal Points
network. It is therefore expected to have a simplified approach to Programme
outcomes; their uptake from the end-users should increase the visibility and
impact of the Programme.

4. In accordance with the Council
Regulation (EC) No 58/2003 of 19 December 2002 laying down the statute for
Executive Agencies to be entrusted with certain tasks in the management of
Community programmes, the Commission has entrusted the Executive Agency for
Health and Consumers with implementation tasks for the management of the
Programme of Community Action in the field of Health since 2005. The Commission
may use, on the basis of a cost-benefit analysis, an existing executive agency
for the implementation of the Health for Growth Programme.

4.
LEGAL ELEMENTS OF THE PROPOSAL

EU action is justified on the grounds both
of the objectives laid down in Article 168 of the Treaty and the subsidiarity
principle. ‘Union action shall complement the national policies and the Member
States’ action.’ The Union can also ‘lend support to their action’.

The second
subparagraph of Article 168(2) states that ‘The Commission may, in close
contact with the Member States, take any useful initiative to promote such
coordination, in particular initiatives aiming at the establishment of
guidelines and indicators, the organisation of exchange of best practice, and
the preparation of the necessary elements for periodic monitoring and
evaluation’; and the third paragraph stipulates that ‘The Union and the Member States shall
foster cooperation with third countries and the competent international organisations
in the sphere of public health.’

Against this
background, Article 168(5) TFEU empowers the European Parliament and the
Council to adopt incentive measures designed to protect and improve human
health.

5.
BUDGETARY IMPLICATION

The financial appropriations for
implementing the programme over the period from 1 January 2014 to 31 December
2020 will amount to 446 million euro (in current prices). This corresponds to
the proposed budget allocation for the Health Programme in the Communication ‘A
Budget for Europe 2020’ of June 2011.

2011/0339 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on
establishing a Health for Growth Programme, the third multi-annual programme of
EU action in the field of health for the period 2014-2020

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article168 (5) thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the
European Economic and Social Committee[6],

Having regard to the opinion of the
Committee of the Regions[7],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1) A high level of health protection
should be ensured in the definition and implementation of all Union policies
and activities, in accordance with Article 168 of the Treaty. The Union shall complement
and support national health policies, encourage the cooperation between Member
States and promote the coordination between their programmes, in full respect
of the responsibilities of the national authorities for shaping their health
policies and organising and delivering health services and medical care.

(2) Continued effort is required in order
to meet the requirements set out in Article 168 of the Treaty. Promoting good
health at EU level is an integral part of the ‘Europe 2020: A European Strategy
for smart, sustainable and inclusive growth’[8].
Keeping people healthy and active for longer will have positive overall health
effects, and a positive impact on productivity and competitiveness, while
reducing pressures on national budgets. Innovation in health helps take up the
challenge of sustainability in the sector in the context of demographic change,
and action to reduce inequalities in health is important to achieve ‘inclusive
growth’. It is appropriate in this context to establish a ‘Health for Growth’
Programme, the third programme of EU action on health (2014-2020) (hereinafter
referred to as ‘the Programme’).

(3) The previous programmes of Community
action in the field of public health (2003-2008) and in the field of health
(2008-2013), adopted respectively by Decisions Nos 1786/2002/EC[9] and 1350/2007/EC of the
European Parliament and of the Council[10],
have been positively assessed as delivering a number of important developments
and improvements. The new programme should build on the achievements of the
previous ones. It should also take into account the recommendations of the
external audits and evaluations carried out, in particular recommendations of
the Court of Auditors[11],
according to which "for the period after 2013, the European Parliament,
the Council and the Commission should reconsider the scope for EU public health
activities and the approach of EU funding in this area. This should be done
bearing in mind the budgetary means available and the existence of other
cooperation mechanisms (…) as a means of facilitating collaboration and the
exchange of information among stakeholders throughout Europe".

(4) In line with the objectives of the
Europe 2020 Strategy, the Programme should focus on a set of well defined
objectives and actions with clear, proven EU added value, and concentrate
support on a smaller number of activities in priority areas. The emphasis will
be placed in accordance with the principle of subsidiarity, on areas where
Member States cannot act in isolation in a cost-effective manner, where there
are clear cross-border or internal market issues at stake, or where there are
significant advantages and efficiency gains from collaboration at EU level.

(5) The programme shall put forward
actions in areas where there is evidence of EU added-value on the basis of the
following criteria: best practice exchange between Member States; supporting
networks for knowledge sharing or mutual learning; addressing cross-border
threats to reduce risks and mitigate their consequences; addressing certain
issues relating to the Internal Market where the EU has substantial legitimacy
to ensure high-quality solutions across Member States; unlocking the potential
of innovation in health; actions that could lead to a system for benchmarking to
allow informed decision-making at European level; improving economies of scale
by avoiding waste due to duplication and optimising the use of financial
resources.

(6) The World Health Organisation (WHO)
European Health Report 2009 identifies scope for increasing investment in public
health and health systems. In this regard, Member States are encouraged to
identify health improvement as a priority in their national programmes and to
benefit from better awareness of the possibilities of EU funding for health.
Therefore, the Programme should facilitate the uptake of its results into the
national health policies.

(7) Innovation in health in terms of
products and services, and the organisation and provision of care, has the
potential to enhance the quality of care to patients and respond to unmet needs,
while also improving the cost-efficiency and sustainability of care. Therefore,
the Programme should facilitate the uptake of innovation in healthcare.

(8) The programme should contribute to
addressing health inequalities through action under the different objectives
and by encouraging and facilitating the exchange of good practices to tackle
them.

(9) The
position of the patient should be strengthened to achieve better and safer
health outcomes. Patients need to be empowered to manage their health and their
healthcare more pro-actively. The transparency of healthcare activities and
systems and the availability of information to patients should be optimised.
Healthcare practices should be informed by feedback from and communication with
patients. Support for Member States, patient
organisations and stakeholders is essential and should be coordinated at EU level in order to effectively help
patients and in particular those affected by rare diseases to benefit from
cross border healthcare.

(10) In the context of an ageing society,
well-directed investments to promote health and prevent diseases can increase
the number of ‘healthy life years’ and thus enable the elderly to continue
working as they grow older. Chronic diseases are responsible for over 80% of
premature mortality in the EU. By identifying, disseminating and promoting the up-take
of validated best practices for cost-effective prevention measures focused on the
key risk factors, namely smoking, abuse of alcohol and obesity, as well as on HIV/AIDS,
the Programme will contribute to prevent diseases and promote good health, also
bearing in mind underlying factors of a social and environmental nature.

(11) To 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), the Programme should contribute to the creation and maintenance of
robust mechanisms and tools to detect, assess and manage major cross-border
health threats.. Due to the nature of these threats, the Programme should
support coordinated public health measures at EU level to address different
aspects, building on preparedness and response planning, robust and reliable
risk assessment and a strong risk and crisis management framework. In this
context, it is important that the programme should benefit from complementarity
with the work programme of the European Centre for Disease Prevention and
Control[12]
in the fight against communicable diseases and the activities supported under
the Unions programmes for research and innovation. Special efforts should be
undertaken to ensure coherence and synergies between the Programme and global
health work carried out under other Community programmes and instruments that
address in particular the areas of influenza, HIV/AIDS, tuberculosis and other
cross-border health threats in third countries. Action under the programme may
also cover cross-border threats to health caused by
biological and chemical incidents, environment and climate change. As stated in the Commission's Communication
"A Budget for Europe 2020", the Commission has committed to
mainstreaming climate change into overall Union spending programmes and to
direct at least 20% of the Union budget to climate-related objectives. Spending
in the Health for Growth Programme under objective 4 will contribute in a general
manner to this objective by addressing health threats associated to climate
change. The Commission will provide information on climate change expenditure within
the Health for Growth Programme.

(12) In accordance with art 114 of
the Treaty, a high level of health protection should be ensured in the
legislation adopted by the Union for the establishment and the functioning of
the Internal Market. In line with this objective, the Programme should undertake special efforts to support actions required by and
contributing to the aims of EU legislation in the fields of medicinal products,
medical devices, human tissues and cells, blood, human organs, communicable
diseases and other health threats, patients' rights in cross-border healthcare
and tobacco products and advertisement.

(13) The Programme should contribute to evidence based decision making by fostering a health
information and knowledge system. The later would consist in, inter alia,
collecting and analysing health data, supporting the scientific Committees[13] and participating in the wide dissemination of the results of the
Programme.

(14) The Programme should focus mainly on
cooperation with national health competent authorities and provide incentives
for wide participation of all Member States. In particular, participation of
Members States with Gross National Income (GNI) lower than 90% of the Union
average should be actively encouraged.

(15) Non-governmental
bodies and health stakeholders, in particular patients' organisations and
health professionals' associations, play an important role in providing the
Commission the information and advice necessary to implement the programme. In
playing this role, they may require contributions from the Programme to enable
them to function. That is why the programme shall be accessible to representative
NGOs and patient organisations working in the public health area, which play an
effective role in civil dialogue processes at EU level, such as for example
participation in consultative groups, and in that way contribute to pursuing the
Programme's specific objectives.

(16) The programme should promote synergies
while avoiding duplication with related Union programmes and actions.
Appropriate use should be made of other Union funds and programmes, in
particular the current and future Union framework programmes for research and
innovation and their outcomes, the Structural Funds, the Programme for social
change and innovation, the European Solidarity Fund, the European strategy for
health at work, the Competitiveness and Innovation Programme, the Framework
Programme for Environment and Climate action (LIFE), the programme of Union
action in the field of consumer policy (2014-2020)[14], the Justice programme
(2014-2020), the Ambient Assisted Living Joint
Programme, (the Education Europe Programme) and the
Union Statistical Programme within their respective activities.

(17) According to Article
168 of the Treaty, the Union and the Member States shall foster cooperation
with third countries and the competent international organisations in the
sphere of public health. The programme should therefore be open 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 and other countries in
accordance with the conditions laid down by a relevant bilateral or
multilateral agreement.

(18) Appropriate
relations with third countries not participating in the programme should be
facilitated to help achieve the objectives of the programme, taking account of
any relevant agreements between those countries and the Union. This may involve
EU organised health events or third countries taking forward complementary
activities to those financed through the programme on areas of mutual interest,
but should not involve a financial contribution under the Programme.

(19) To maximise the effectiveness and
efficiency of actions at Union and international level, cooperation should be
developed with relevant international organisations such as the United Nations
and its specialised agencies, in particular the World Health Organisation, as
well as with the Council of Europe and the Organisation for Economic
Cooperation and Development, with a view to implementing the Programme.

(20) The programme should run for a period
of seven years to align its duration with that of the Multi-annual Financial Framework
as set out in [Article 1] of the Council Regulation laying down the multiannual
financial framework for the year 2014-2020. This Regulation lays down, for the
entire duration of the Programme, a financial envelope constituting the prime
reference within the meaning of point (17) of the Inter-institutional Agreement
of XX/YY/201Z between the European Parliament, the Council and the Commission
on budgetary discipline and sound financial management [link], for the
budgetary authority during the annual budgetary procedure.

(21) In accordance with Article 49 of Council
Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial
Regulation applicable to the general budget of the European Communities[15], this Regulation provides the
legal basis for the action and for the implementation of the Health for Growth
Programme.

(22) In order to ensure uniform conditions
for the implementation of this Regulation by means of annual work programmes,
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 of 16 February 2011 laying down the rules and
general principles concerning mechanisms for control by Member States of the
Commission's exercise of implementing powers[16].

(23) The Programme should be implemented in
full respect of the principle of transparency and with a reasonable balance
between its different objectives. Appropriate actions covered by the
programme's specific objectives and with a clear EU added value should be
selected and funded by the Programme. The annual work programmes should set
out, in particular, the essential selection criteria applicable to the
potential beneficiaries, in accordance with the Financial Regulation, in order
to ensure they have the financial and operational capacity to undertake
activities financed under the Programme, and, where appropriate, the evidence
required to demonstrate their independence.

(24) The value and impact of the Programme
should be regularly monitored and evaluated. Its evaluation should take into
account the fact that the achievement of the Programme's objectives may require
a longer time period than its duration.

(25) The cooperation of national
authorities is essential in sharing information with potential applicants
to allow equitable participation in the Programme, and knowledge produced by
the programme with the different national health sector stakeholders. Moreover,
their involvement in tracing the impacts generated by the Programme at national
level is considered of major importance. Thus, National Focal Points should be designated
by the Member States in order to support the above mentioned activities.

(26) The financial interests of the
European Union should be protected through proportionate measures throughout
the expenditure cycle, including the prevention, detection and investigation of
irregularities, the recovery of funds lost, wrongly paid or incorrectly used
and, where appropriate, penalties.

(27) A transition should be ensured between
the new programme and the previous programme it replaces, in particular
regarding the continuation of multi-annual arrangements for its management,
such as the financing of technical and administrative assistance. As of 1
January 2021, the technical and administrative assistance appropriations should
cover, if necessary, the expenditure related to the management of actions not
yet completed by the end of 2020.

(28) This Regulation replaces Decision No
1350/2007/EC. That Decision should therefore be repealed,

HAVE ADOPTED THIS REGULATION:

Chapter I

General provisions

Article 1

Establishment
of the Programme

This Regulation establishes a third
multi-annual programme of Union action in the field of health, called Health
for Growth Programme, covering the period from 1 January 2014 to 31 December
2020 (hereinafter referred to as "the Programme").

Article 2

General
objectives

The general objectives of the Health for
Growth Programme shall be to work with the 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.

Chapter II

Objectives and actions

Article 3

Specific
objectives and indicators

The general objectives referred to in
Article 2 shall be pursued through the following specific objectives:

(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.

This objective will be measured in particular
through the increase of number of Member States using the developed tools and
mechanisms and pieces of advice.

(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.

This objective will be measured in
particular through the increase of number of health professionals using the
expertise gathered through the European Reference Networks in the context of Directive 2011/24/EU on the application of
patients' rights in cross-border healthcare (hereinafter referred to as
"the European Reference Networks"); the
increase of number of patients using these networks; and the increase of number
of Member States using the developed guidelines.

(3) To identify, disseminate and promote
the up-take of validated best practices for cost-effective prevention measure
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.

This objective will be measured in
particular through the increase of number of Member States involved in
promoting good health and preventing diseases, using the validated best
practices.

(4) To develop common approaches and
demonstrate their value for better preparedness and coordination in health
emergencies in order to protect citizens from cross-border health threats.

This objective will be measured in
particular through the increase of number of Member States integrating the
developed common approaches in the design of their preparedness plans.

Article 4

Eligible
actions

The objectives referred to in Article 3 shall
be achieved through the actions listed below and according to the priorities
set out in the work programme referred to in Article 11 of this Regulation.

(1) Contributing to innovative and
sustainable health systems:

–
1.1.    Develop EU cooperation on Health Technology
Assessment in the context of Directive 2011/24/EU on the application of
patients' rights in cross-border healthcare;

–
1.2.    Promote the uptake of health innovation
and e-Health by increasing the interoperability of e-Health applications;

–
1.3.    Support the sustainability of EU health
workforce by promoting effective forecasting and planning and efficient
recruitment and retention strategies;

–
1.4.    Provide expertise to assist Member
States undertaking health systems reforms;

–
1.5     Support to the European Innovation
Partnership on Active and Healthy Ageing, a pilot project under Europe 2020
flagship initiative Innovation Union[17];

–
1.6     Actions required by or contributing to
the objectives of EU legislation in the fields of medical devices as well as
e-Health and Health Technology Assessment provisions in legislation on cross
border healthcare;

–
1.7     Foster a health knowledge system,
including Scientific Committees, to contribute to
evidence-based decision making.

(2) Increasing access to better and safer
healthcare for citizens:

–
2.1.    Set up accreditation and support
European Reference Networks;

–
2.2.    Support action on rare diseases including
creation of European Reference Networks (in accordance with 2.1), information
and registries based on the common criteria for accreditation;

–
2.3.    Strengthen collaboration on patient
safety and quality of healthcare, by increasing the
availability of information to patients, exchange of best practices and
development of guidelines; support action on chronic
diseases care and research including development of European guidelines;

–
2.4.    Develop guidelines to improve the
prudent use of antimicrobials in human medicine and reduce the practices that
increase antimicrobial resistance;

–
2.5.    Actions required by or contributing to
the objectives of EU legislation in the fields of tissues and cells, blood,
organs, patients' rights in cross-border healthcare and medicinal products;

–
2.6.    Foster a health knowledge system, to contribute to evidence-based decision making.

(3) Promoting good health and preventing
diseases:

–
3.1     Exchange best practices on key health
issues such as smoking prevention, abuse of alcohol and obesity;

–
3.2.    Supporting the prevention of chronic
diseases including cancer, by sharing knowledge and best practice and
developing joint activities;

–
3.3.    Actions required by or contributing to
the objectives of EU legislation in the fields of tobacco products and
advertisement;

–
3.4.    Foster a health knowledge system, to contribute to evidence-based decision making.

(4) Protecting citizens from cross border
health threats:

–
4.1.    Strengthen preparedness and response for
serious cross border health threats;

–
4.2.    Improve risk assessment capacity by
providing additional capacities for scientific expertise and map existing
assessments;

–
4.3.    Support capacity building against health
threats in Member States by inter alia developing preparedness and
response planning and coordination, common approaches to vaccination,
developing guidelines and mechanisms for joint procurement of medical
countermeasures;

–
4.4.    Actions required by or contributing to
the objectives of EU legislation in the fields of communicable diseases and
other health threats;

–
4.5.    Foster a health knowledge system to contribute to evidence-based decision making.

A more detailed description of the content
those actions may have is included in Annex I. An
indicative list of the relevant legislation is provided in Annex II to this
Regulation.

Chapter III

Financial
provisions

Article 5

Funding

1. The financial allocation for the
implementation of the Programme for the period from 1 January 2014 to 31
December 2020 is hereby set at EUR 446 000 000 in
current prices.

Article 6

Participation
of third countries

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

(a)        acceding
countries, candidate countries and potential candidates benefiting from a
pre-accession strategy, in accordance with the general principles and general
terms and conditions for their participation in Union programmes established in
the respective Framework Agreements, Association Council Decisions or similar
Agreements;

(b)        EFTA/EEA
countries in accordance with the conditions established in the EEA Agreement;

(c)        neighbouring countries
and the countries to which the European Neighbourhood Policy (ENP) applies in accordance
with the conditions laid down by a relevant bilateral or multilateral
agreement;

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

Article 7

Types
of intervention

1. In accordance with the Financial
Regulation, 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.

2. Grants may be awarded to fund:

(a)        actions having
a clear EU added value co-financed by the competent authorities of the Member
States responsible for Public Health or the third countries participating pursuant
to Article 6, or by non-governmental bodies mandated by these competent
authorities;

(b)        actions having a clear EU added value co-financed by other public or
private bodies, as referred to in article 8 (1), including international
organisations active in the area of health and for the latter, where
appropriate without previous call for proposal, duly justified in the annual work
programmes;

(c)        the functioning of non governmental bodies as referred to in article
8(2) where financial support is necessary to the pursuit of one or more of the specific
objectives of the Programme.

3. Grants paid by the Union shall not
exceed the following levels:

(a)        60 % of eligible costs for an action aimed at an objective of the
Programme. In cases of exceptional utility, the contribution by the Union may
be up to 80% of eligible costs;

(b)        60 % of eligible costs for the functioning of a non-governmental
body. In cases of exceptional utility such bodies may benefit from a financial contribution
up to a maximum of 80% of eligible costs;

(c)        60 % of eligible costs for actions referred to in point (a) of paragraph
2 except for Member States whose gross national income per inhabitant is less
than 90 % of the Union average, which shall benefit from a financial
contribution up to a maximum of 80 % of eligible costs. In cases of exceptional
utility, the financial contribution for actions referred to in point (a) of paragraph
2 may be up to a maximum of 80% of eligible costs for competent authorities of all
Member States or third countries participating in the
Programme.

4. Grants may be paid in the form of lump
sums, standard scales of unit costs or flat-rate financing where this is suited
to the nature of the actions concerned.

Article 8

Beneficiaries
eligible for grants

1. The grants for actions referred to under
Article 7 (2) (a) and (b) 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.

2. The grants for the functioning of bodies
referred to under Article 7 (2) (c) may be awarded to the bodies which comply
with all the following criteria:

(a)        They are
non-governmental, non-profit-making, independent of industry, commercial and business
or other conflicting interests;

(b)        They are working
in the public health area, playing an effective role in civil dialogue
processes at EU level and pursuing at least one of the specific objectives of
the Programme as referred to in article 3;

(c)        They are active
at the Union level and in at least half of the Member States, and have a
balanced geographical coverage of the Union.

Article 9

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 European Union as
far as they are related to the general objectives of this Regulation, expenses
linked to IT networks focusing on information exchange, as well as all other
technical and administrative assistance expense incurred by the Commission for
the management of the Programme.

Chapter IV

Implementation

Article 10

Methods
of implementation

The Commission shall be responsible for the
implementation of the Programme in compliance with the management modes set out
in the Financial Regulation.

Article 11

Annual
Work programmes

1. The Commission shall implement the
Programme by establishing annual work programmes setting out the elements
provided in the Financial Regulation and in particular:

(a)        the priorities and the actions to be undertaken, including the allocation of
financial resources;

(b)        detailed
eligibility criteria for the beneficiaries in compliance with Article 8;

(c)        the criteria for
the percentage of the financial contribution of the Union, including criteria
for assessing whether or not exceptional utility applies, and the applicable
rate of the co-financing;

(d)        the essential
selection and award criteria to be used to select the proposals receiving
financial contributions;

(e)        the time schedule
of the planned calls for the tenders and calls for proposals;

(f)         where appropriate, the authorisation to use lump sums, standard
scales of unit costs or flat-rate financing in line with the Financial
Regulation;

(g)        the actions
co-financed by international organisations active in the area of health without
previous call for proposal duly justified.

2. The working programme referred to in
paragraph 1 shall be adopted in accordance with the examination procedure referred
to in Article 16(2).

3. In implementing the Programme, the
Commission, together with the Member States, shall ensure compliance with all
relevant legal provisions regarding personal data protection and, where
appropriate, the introduction of mechanisms to ensure the confidentiality and
safety of such data.

Article 12

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.

Article 13

Monitoring,
evaluation and dissemination of results

1. 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, including
information on the amount of climate related expenditure. It shall report
thereon to the committee referred to in Article 13, and shall keep the European
Parliament and the Council informed.

2. At the request of the Commission, which
shall avoid causing any disproportionate increase in the administrative burden on
the Member States, Member States shall submit any available information on the
implementation and impact of the Programme.

3. 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 evaluation shall
additionally address the scope for simplification, its internal and external
coherence, the continued relevance of all objectives, as well as the
contribution of the measures to the Union priorities of smart, sustainable and
inclusive growth. It shall take into account evaluation results on the
long-term impact of the predecessor programme.

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.

4. The Commission shall make the results of
actions undertaken pursuant to this Regulation publicly available and shall
ensure they are widely disseminated.

Article 14

National Focal Points

Member States
shall designate National Focal Points which shall assist the Commission in the
promotion of the Programme, the dissemination of the results of the Programme
and the information on impacts generated by the Programme in their respective
countries.

Article 15

Protection
of the financial interests of the European Union

1. The Commission shall take appropriate
measures ensuring that, when actions financed under this Regulation are
implemented, the financial interests of the European Union are protected by the
application of preventive measures against fraud, corruption and any other
illegal activities, by effective checks and, if irregularities are detected, by
the recovery of the amounts wrongly paid and, where appropriate, by effective,
proportionate and deterrent penalties.

2. The Commission or its representatives
and the Court of Auditors shall have the power of audit, on the basis of
documents and on-the spot, over all grant beneficiaries, contractors and subcontractors
who have received Union funds.

The European Anti-fraud Office (OLAF) may carry
out on-the-spot checks and inspections on economic operators concerned directly
or indirectly by such funding in accordance with the procedures laid down in
Regulation (Euratom, EC) No 2185/96 with a view to establishing whether there
has been fraud, corruption or any other illegal activity affecting the
financial interests of the European Union in connection with a grant agreement
or grant decision or a contract concerning Union funding.

Without prejudice to the first and second subparagraphs,
cooperation agreements with third countries and international organisations and
grant agreements and grant decisions and contracts resulting from the
implementation of this Regulation shall expressly empower the Commission, the
Court of Auditors and OLAF to conduct such audits, on-the-spot checks and
inspections.

Chapter V

Procedural provisions

Article 16

Committee
procedure

1. The Commission shall be assisted by a
committee within the meaning of Regulation (EU) No. 182/2011.

2. Where reference is made to the first
paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

3. Where the
opinion of the committee is to be obtained by the written procedure, that
procedure shall be terminated without result when, within the time-limit for
delivery of the opinion, the chair of the committee so decides or a simple
majority of committee members so request.

Chapter VI

Transitional and final provisions

Article 17

Transitional
provisions

1. The financial allocation for the
Programme may also cover technical and administrative assistance expenses
necessary to ensure the transition between the Programme and the measures
adopted under Decision No 1350/2007/EC.

2. If necessary, appropriations may be entered in the budget beyond
2020 to cover the expenses provided for in Article 9, to enable the management
of actions not completed by 31 December 2020.

Article 18

Repeal
provisions

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

Article 19

Entry
into force

This Regulation
shall enter into force on the twentieth day following that of its publication
in the Official Journal of the European Union. This Regulation shall be
binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament                       For
the Council

The President                                                 The
President

ANNEX I

Types of actions

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

1.1. Health
technology assessment: support European cooperation on Health Technology Assessment
(HTA) under the European voluntary network on Health Technology Assessment set up by the Directive 2011/24/EU
of the European Parliament and of the Council[18].
Facilitate the uptake of the results streaming from research projects supported
under 7th Framework Programme and the in the longer term the activities which will be undertaken in the
forthcoming research and innovation programmes 2014-2020 (Horizon 2020).

1.2. Health innovation and e-Health: increasing
the interoperability of patient registers and other e-Health solutions; support
European cooperation on e-Health, notably on registries and uptake by health
professionals. This will serve the European voluntary network on e-Health set
up by the Directive 2011/24/EU of the European Parliament and of the Council.

1.3. Health workforce: develop effective
health workforce forecasting and planning in terms of numbers, scope of
practice and skills, monitor mobility (within the Union) and migration of
health professionals, establish efficient recruitment and retention strategies
and capacity development.

1.4. Decision making on health systems
reforms: set up a mechanism for pooling expertise at Union level, to provide
sound and evidence-based advice on effective and efficient investment in public
health and health systems. Facilitate the uptake of the results streaming from
research projects supported under the 7th Framework Programme and
the in the longer term the activities
which will be undertaken in the forthcoming research and innovation programme
2014-2020 (Horizon 2020).

1.5. Support for the European Innovation
Partnership on Active and Healthy Ageing in its three themes: innovation in
awareness, prevention and early diagnosis; innovation in cure and care and
innovation for active ageing and independent living.

1.6. Actions required by or contributing to
the implementation of Union legislation in the field of medical devices and
cross border healthcare (e-Health and HTA). Such action
may include activities aimed at ensuring the implementation, application,
monitoring and review of that legislation.

1.7. Fostering a health knowledge system to
contribute to evidence-based decision making including collecting and analysing
health data and wide-dissemination of the results of the Programme and
including support to the Scientific Committees set up
in accordance with Commission Decision 2008/721/EC.

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

2.1. Access: support the establishment
of a system of European Reference Networks to enable inter alia the
mobility of medical expertise for patients with conditions requiring highly specialised
care and a particular concentration of resources or expertise, like in the case
of rare diseases, on the basis of criteria to be set under Directive on the
application of patients' rights in cross-border healthcare (Directive
2011/24/EU)[19].

2.2 Rare diseases: support
Member States, patient organisations and stakeholders by coordinated action at Union level in order to effectively
help patients affected by rare diseases. This includes creation of reference networks (in compliance with point 2.1), information
and registries for rare diseases based on the common criteria of accreditation.

2.3. Quality and safety: strengthen
collaboration on patient safety and quality of healthcare, through, inter alia, implementing
the Council Recommendation on patient safety and the prevention and control of
healthcare-associated infections; exchange best practice on quality assurance
systems; develop guidelines and tools to promote patient safety and quality;
increase the availability of information to patients on safety and quality,
improve feedback and interaction between health providers and patients; support
action to exchange knowledge and best practice on chronic diseases care, the
response of health systems and research including development of European
guidelines.

2.4. Safety: improve the prudent use of
antimicrobial agents in medicinal products and reduce the practices that
increase antimicrobial resistance; reduce the burden of resistant infections
and healthcare-associated infections and secure the availability of effective
antimicrobials.

2.5. Actions required by or contributing to
the implementation of Union legislation in the fields of tissues and cells,
blood, organs, medicinal products use and patients' rights in cross-border healthcare. Such action may include
activities aimed at ensuring the implementation, application, monitoring and
review of that legislation.

2.6. Fostering a health knowledge system to
contribute to evidence-based decision making including collecting and analysing
health data and wide dissemination of the results of the Programme.

3. Identifying, disseminating and
promoting up-take of validated best practices for cost-effective prevention
measure 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

3.1. Cost-effective promotion and
prevention measures: this will include actions towards
the setting up of pan-European networks and partnerships engaging wide range of
actors in communication and awareness raising actions on key health issues such
as smoking prevention, abuse of alcohol, addressing obesity with a focus on the cross-border dimension and on Member States with
no or little action on these issues.

3.2. Chronic diseases: support European
cooperation and networking on preventing and improving the response to chronic
diseases including cancer, by sharing knowledge, good practice and developing
joint activities on prevention. Cancer: follow-up work already undertaken; set
up a European cancer information system with comparable data; support cancer
screening, including voluntary accreditation mechanisms; support the
development of European guidelines for prevention where major inequalities exist.

3.3. Actions required by or contributing to
the implementation of Union legislation in the fields of tobacco products and
advertisement. Such action may include activities aimed at ensuring the
implementation, application, monitoring and review of that legislation.

3.4. Fostering a health knowledge system to
contribute to evidence-based decision making including collecting and analysing
health data and wide dissemination of the results of the Programme.

4. Developing common approaches and
demonstrating their value for better preparedness and coordination in health
emergencies in order to protect citizens from cross-border health threats

4.1. Preparedness to and response for
serious cross border health threats taking into account and coordinating with
global initiatives: put in place common components of generic and specific
preparedness planning, including for pandemic influenza, and report regularly
on implementation of preparedness plans.

4.2. Risk assessment capacity: close gaps
in risk assessment capacities by providing additional capacities for scientific
expertise and map existing assessments to improve coherence at Union level.

4.3. Support capacity building against
health threats in Member States: develop preparedness and response planning,
public health response coordination, common approaches on vaccination; develop
guidelines on protective measures in an emergency situation, guidelines on
information and guides to good practice; set up a new mechanism for joint
procurement of medical countermeasures; develop common communication
strategies.

4.4. Actions required by or contributing to
the implementation of Union legislation in the fields of communicable diseases
and other health threats, including those caused by biological, and chemical incidents,
environment and climate change. Such action may include activities aimed at
ensuring the implementation, application, monitoring and review of that
legislation.

4.5. Fostering a health knowledge system to
contribute to evidence-based decision making including collecting and analysing
health data and wide- dissemination of the results of the Programme.

This list might be completed with
additional actions of similar type and impact pursuing the specific objectives
mentioned in Article 3.

 ANNEX II

Indicative list of the relevant legislation referred to in Article 4
and Annex I

1. Blood, organs, tissues and cells

1.1. Directive 2002/98/EC of the European Parliament and the Council of 27January
2003,

setting standards of
quality and safety for the collection, testing, processing, storage and
distribution of human blood and blood components and amending Directive
2001/83/EC (OJ L 33, 8.2.2003, p. 30).

1.2. Directive 2010/45/EU of the European Parliament and the Council of 7
July 2010,

on standards of
quality and safety of human organs intended for transplantation (OJ L 207,
6.8.2010, p. 14).

1.3. Directive 2004/23/EC of the European Parliament and the Council of 31
March 2004,

on setting standards
of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells (OJ L 102,
7.4.2004, p. 48).

Only important basic legislation has been listed here; for other
legislation relating to blood, organs, tissues and cells please see:

http://ec.europa.eu/health/blood\_tissues\_organs/key\_documents/index\_en.htm#anchor3

2. Communicable diseases

2.1.  Decision N° 2011/98/EC of the
European Parliament and the Council of 24 September 1998,

setting up a network
for the epidemiological surveillance and control of communicable diseases in
the Community (OJ L 268, 3.10.1998, p. 1).

2.2. Regulation (EC) No851/2004
of the European Parliament and of the Council of 21 April 2004,

establishing a European
Centre for Disease and Prevention and Control (OJ L 142,
30.4.2004, p. 1).

Only important basic legislation has listed here; for other
legislation relating to diseases please see:

http://ec.europa.eu/health/communicable\_diseases/key\_documents/index\_en.htm#anchor1

3. Tobacco products and advertisement

3.1. Directive
2001/37/EC of the European Parliament and the Council of 5 June 2001,

on the approximation
of the laws, regulations and administrative provisions of the Member States
concerning the manufacture, presentation and sale of tobacco products (OJ L 194,
18.7.2001, p. 26).

3.2. Directive  2003/33/EC
of the European Parliament and the Council of 26 May 2003,

on the approximation of
the laws, regulations and administrative provisions of the Member States
relating to the advertising and sponsorship of tobacco products (OJ L 152, 20.6.2003, p. 16).

Only important basic legislation has been listed
here; for other legislation relating to tobacco please see: http://ec.europa.eu/health/tobacco/law/index\_en.htm

4. Patients’ rights in cross border health care

4.1. Directive
2011/24/EU of the European Parliament and the Council of 9
March 2011,

on the application of
patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

5. Pharmaceutical products

5.1. Regulation (EC) No
726/2004 of the European
Parliament and of the Council of 31 March 2004,

laying down
Community procedures for the authorisation and supervision of medicinal products
for human and veterinary use and establishing a European Medicines Agency (OJ L
136, 30.4.2004, p. 1).

5.2. Council Regulation (EC) No 297/95 of 10
February 1995,

on fees payable to
the European Agency for the Evaluation of Medicinal Products (OJ L 35,
15.2.1995, p. 1).

5.3. Directive 2001/83/EC of the European
Parliament and of the Council of 6 November 2001,

on the Community
code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

5.4. Regulation (EC) No 141/2000 of the
European Parliament and of the Council of 16 December 1999,

on orphan medicinal
products (OJ L 18, 22.1.2000, p. 1).

5.5. Regulation (EC) No 1901/2006 of the
European Parliament and of the Council of 12 December 2006,

on medicinal
products for paediatric use and amending Regulation (EEC) No 1768/92, Directive
2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378,
27.12.2006, p. 1).

5.6. Regulation (EC) No 1394/2007 of the
European Parliament and of the Council of 13 November 2007,

on advanced therapy
medicinal products and amending Directive 2001/83/EC and Regulation (EC) No
726/2004 (OJ L 324, 10.12.2007, p. 121).

5.7. Directive 2001/20/EC of the European
Parliament and of the Council of 4 April 2001,

on the approximation
of the laws, regulations and administrative provisions of the Members States
relating to the implementation of good clinical practice in the conduct of
clinical trials on the medicinal products for human use (OJ L 121, 1.5.2001, p.
34).

5.8. Directive 2001/82/EC of the European
Parliament and of the Council of 6 November 2001,

on the Community
code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p.1).

5.9. Regulation (EC) No 470/2009 of the
European Parliament and of the Council of 6 May 2009,

laying down
Community procedures for the establishment of residue limits of
pharmacologically active substances in foodstuffs of animal origin, repealing
Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the
European Parliament and of the Council and Regulation (EC) No 726/2004 of the
European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

Only important basic legislation has been listed here; for other
legislation relating to pharmaceutical products, please see:

Products
for human use: http://ec.europa.eu/health/documents/eudralex/vol-1/index\_en.htm

Products for
veterinary use: http://ec.europa.eu/health/documents/eudralex/vol-5/index\_en.htm

6. Medical devices

6.1. Directive 90/385/EC of the European
Parliament and of the Council of 20 June 1990,

on the approximation
of the laws of the Member States relating to active implantable medical devices
(OJ L 189, 20.7.1990, p. 17).

6.2. Directive 93/42/EC of the European
Parliament and of the Council of 14 June 1993,

concerning medical
devices (OJ L 169, 12.7.1993, p. 1).

6.3. Directive 98/79/EC of the European
Parliament and of the Council of 27 October 1998

on in vitro diagnostic
medical devices (OJ L 331, 7.12.1998, p. 1).

Only important basic legislation has been
listed here; for other legislation relating to medical devices please see: http://ec.europa.eu/health/medical-devices/documents/index\_en.htm

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE
PROPOSAL/INITIATIVE

              1.1.    Title of the proposal/initiative

              1.2.    Policy
area(s) concerned in the ABM/ABB structure

              1.3.    Nature
of the proposal/initiative

              1.4.    Objective(s)

              1.5.    Grounds
for the proposal/initiative

              1.6.    Duration
and financial impact

              1.7.    Management
method(s) envisaged

2.           MANAGEMENT MEASURES

              2.1.    Monitoring
and reporting rules

              2.2.    Management
and control system

              2.3.    Measures
to prevent fraud and irregularities

3.           ESTIMATED FINANCIAL
IMPACT OF THE PROPOSAL/INITIATIVE

              3.1.    Heading(s)
of the multiannual financial framework and expenditure budget line(s) affected

              3.2.    Estimated
impact on expenditure

              3.2.1. Summary of estimated impact on expenditure

              3.2.2. Estimated
impact on operational appropriations

              3.2.3. Estimated
impact on appropriations of an administrative nature

              3.2.4. Compatibility
with the current multiannual financial framework

              3.2.5. Third-party
participation in financing

              3.3.    Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT

6.
FRAMEWORK OF THE PROPOSAL/INITIATIVE
6.1.
Title of the proposal/initiative

HEALTH FOR GROWTH PROGRAMME (2014 – 2020)

6.2.
Policy area(s) concerned in the ABM/ABB
structure

PUBLIC HEALTH

6.3.
Nature of the proposal/initiative

¨ The
proposal/initiative relates to a new action

¨ The
proposal/initiative relates to a new action following a pilot
project/preparatory action[20]

þThe proposal/initiative relates to the
extension of an existing action

¨ The
proposal/initiative relates to an action redirected towards a new action

6.4.
Objectives
6.4.1.
The Commission's multiannual strategic
objective(s) targeted by the proposal/initiative

The Health for Growth Programme would seek to contribute to the two
main strategic objectives/goals below:

INNOVATION:

where the Programme would seek to facilitate the uptake by policymakers
and public-health practitioners of innovative solutions, technological and organisational,
for improving the quality and sustainability of health systems and increasing
access to better and safer healthcare.

PREVENTION:

where the Programme would seek to promote good health and
preventing diseases at EU level by helping and complementing Member States'
efforts to increase their citizens' number of healthy life years.

The programme will support the general objectives of the future
public health policy.

6.4.2.
Specific objective(s) and ABM/ABB activity(ies)
concerned

Specific objective No 1:

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

Specific objective No 2:

Increase access to medical expertise (European reference networks)
and information for specific conditions and beyond national borders and 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.

Specific objective No 3:

Identify, disseminate and promote up-take of validated best
practices for cost-effective prevention measure by addressing 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.

Specific objective No 4:

Develop common approaches and demonstrate their value for better
preparedness and coordination in health emergencies in order to protect
citizens from cross-border health threats.

ABM/ABB activity concerned

PUBLIC HEALTH POLICY for all the specific objectives listed above.

6.4.3.
Expected result(s) and impact

Specific objective No 1:

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

Effects at the programme's level:

Have the highest number of Member States (through their policy
makers, health professionals, health institutions) using the developed tools,
mechanisms and guidelines /pieces of advice.

Effects at policy level:

Member States (Policy makers, health professionals, health institutions)
are provided with effective support in:

\* Implementing innovation in health in their health systems.

\* Reaching an adequate supply of health professionals in
MS.

\* Reaching a cost-effective use of medical technologies.

\* Improving decision-making, organisational management
and performance of the health systems.

Beneficiaries:

Member States through Health policy makers, health professionals and
health institutions.

Specific objective No 2:

Increase access to medical expertise (European reference networks)
and information for specific areas and beyond national borders and 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.

Effects at the programme's level:

Have the highest number of health professionals using the expertise
gathered through the European Reference Networks put in place and operating.

Have the highest number of Member States (through their policy
makers, health professionals, health institutions) using the developed
guidelines.

Effects at policy level:

Member States are provided with support in improving access to
diagnosis and provision for all patients requiring highly specialised care for
a specific disease or group of diseases.

Member States are provided with support in reducing morbidity and
mortality related to healthcare quality and increasing patients / citizens
confidence in the health care system.

Beneficiaries:

Member States through Health policy makers and health professionals and
ultimately patients and citizens.

Specific objective No 3:

Identify, disseminate and promote up-take of validated best
practices for cost-effective prevention measure 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.

Effects at the programme's level:

Have the highest number of Member States, through their policy
makers, health professionals, health institutions and stakeholders from bodies
involved in lifestyles, using the validated best practices.

Effects at policy level:

Member States are provided with support in their efforts to reduce
risk factors for chronic diseases

Beneficiaries:

Member States through Health policy makers, health professionals,
health institutions; NGOs committed in the promotion of health, and ultimately
citizens.

Specific objective No 4:

Develop common approaches and demonstrate their value for better
preparedness and coordination in health emergencies in order to protect
citizens from cross-border health threats.

Effects at the programme's level:

Have the highest number of Member States, through their policy
makers, health professionals, health institutions, integrating the developed
common approaches in the design of their preparedness plans.

Effects at policy level:

Support MS putting in place a strong set of coordinated public
health measures at EU level to help minimise the public health consequences of
cross-border health threats (which could range from mass contamination caused
by chemical incidents to epidemics or pandemics).

Beneficiaries:

Member States through Health authorities, health professionals,
health institutions and other competent bodies involved in interior affairs and
civil protection.

6.4.4.
Indicators of results and impact

Specific objective No 1

Outcome indicators:

Number of tools and mechanisms developed by 2017, 2020 and 2023.

Number of guidelines/recommendations/pieces of advice given as from
2015 and then every year.

Impact indicators:

Number of Member States (through their policy makers, health
professionals, health institutions) using the developed tools and mechanisms
and pieces of advice by 2018, 2021 and 2024.

Specific objective No 2

Outcome indicators:

Number of operating European Reference Networks by 2017, 2020 and
2023.

Number of guidelines developed by 2017, 2020 and 2023

Impact indicators:

Number of health professionals using the expertise gathered through
the European Reference Networks put in place and operating by 2018, 2021 and
2024.

Number of Member States (through their policy makers, health
professionals, health institutions) using the developed guidelines by 2018,
2021 and 2024.

Number of patients using European Reference Networks (in other
Member State than the state where they live)

Specific objective No 3

Outcome indicators:

Number of validated best practices developed by 2017, 2020 and 2023.

Increase in number of up-takes of cancer screening guidelines by the
health professionals.

Impact indicators:

Number of Member States, through their policy makers, health
professionals, health institutions and stakeholders from bodies involved in
promoting good health and preventing diseases, using the validated best
practices by 2018, 2021 and 2024.

Specific objective No 4

Outcome indicators:

Number of common approaches developed by 2017, 2020 and 2013.

Impact indicators:

Number of Member States, through their health authorities, health
professionals, health institutions, and other competent bodies involved in
interior affairs and civil protection, integrating the developed common
approaches in the design of their preparedness plans by 2018, 2021 and 2024.

6.5.
Grounds for the proposal/initiative
6.5.1.
Requirement(s) to be met in the short or long
term

The post 2013 "Health for Growth" programme will support
the implementation of the Commission's actions in the field of Public Health
policy from 2014 onwards. The new programme will build on the results achieved
through the current (2008 – 2013) programme, taking also into account the
recommendations of the ex-post evaluation of the programme 2003 – 2007 and of
the mid-term evaluation of the programme 2008 – 2013.

The Programme will seek to support the Commission, Member States and
key stakeholders in designing, coordinating and implementing effective policies
which will aim at tackling the following long term challenges:

\* financial sustainability of the health systems in Europe as a
result of an ageing population, and taking into account the current situation
of public finances in the MS;

\* health workforce shortages as a result of a dwindling working-age
population and an increase in demand for such workforce;

\* need for improvement in patient safety and quality of healthcare
as more than half of EU citizens are afraid of being harmed in the healthcare
process;

\* lack of sustained progress on control and prevention of chronic
conditions which results in the loss of best productive years

\* increasing health inequalities in health throughout Europe

\* to be prepared to face global and cross border health threats
which could range from mass contamination caused by chemical incidents to
epidemics or pandemics, like those unleashed recently by E coli, H1N1 or
SARS (severe acute respiratory syndrome).

In the short term, the programme will also be taking the following
actions:

\* support for implementation of legislation in health and fulfilling
Commission's obligations for medicinal products and medical devices;

\* a need for EU wide sound, comparable and accessible evidence,
statistics and indicators.

6.5.2.
Added value of EU involvement

The proposed Programme offers financial opportunities to build and
launch cooperation mechanisms and coordination processes between Member States
with the view to identifying common tools and best practices that could create
synergies, bring EU added value and lead to economies of scale. The Programme
cannot replace Member States' action. Instead, as stated in Article 168 of the
Treaty on the Functioning of the European Union, EU action must complement
national policies and encourage cooperation between Member States. Thus, the
programme should contribute only where Member States could not act individually
or where coordination is the best way to move forward. It is acknowledged that
health problems vary from one Member State to another and that Member States'
capacity to solve them might not necessarily be equal. From this perspective,
cooperation might not always be a process that is self-organising and natural.
The Programme will therefore intervene, preferably, where it can promote and
steer this coordination at European level, while also serving the interests of
the Member States and of the wider public health agenda.

The objectives of the proposed Programmes reflect the areas in which
it has clearly attested and verified that the Programme provides EU added value.
These are: fostering best practice exchange between Member States; supporting
networks for knowledge sharing or mutual learning; addressing cross-border
threats to reduce risks and mitigate their consequences; addressing certain
issues relating to the internal market where EU has substantial legitimacy to
ensure high-quality solutions across Member States; unlocking the potential of
innovation in health; actions that could lead to a system for benchmarking;
improving economies of scale by avoiding waste due to duplication and
optimising use of financial resources.

6.5.3.
Lessons learned from similar experiences in the
past

Summary of the ex-post evaluation of the Public Health Programme for
2003-2007and the mid-term evaluation of the Health Programme for 2008-2013:

The evaluations of the Health Programme recognise its strong
potential contribution to preparing, developing and implementing EU public
health policies.

Even though the Health Programme is relatively minor in terms of
magnitude, it is instrumental in creating and maintaining a strong professional
public health community at European level that exchanges knowledge and
experience. It has a significant impact on the work done by public health
practitioners across the EU, achieving a certain, albeit modest, global
resonance that is important for its overall recognition. As a matter of fact,
the presently modest yet laudable efforts on data collection and exchanges
between Member States would not have taken place without the support of the
Health Programme.

Support from the Health Programme made it possible to develop
activities, for example on health determinants and comparable health data, in
new Member States, where the economic situation and budget restrictions would
not have allowed them to be made a priority.

The current Health Programme has promoted important issues at EU
level and on national political agendas, such as rare diseases and
cancer-screening guidelines, and has influenced policymaking and implementation
at national level.

At management level, there has been a significant improvement in
delivery of the Programme following the first five-year cycle, mainly due to
outsourcing management to the Executive Agency for Health and Consumers. The
procedure for selecting the action to be funded has been tightened up to make
sure that the right applicants are selected for funding. The new financial
mechanisms have generally been received positively and have all been used.

However, stakeholders as well as programme committee members think
that the objectives are too broad to the extent of being sometimes unclear and
that there are too many priorities in the annual work plans. The evaluations
recommended to refine the objectives of the Health Programme for them to be
more tangible and focussed on certain public health issues, especially those
that are difficult for Member States to reach individually.

The evaluations also recommended to reduce the number of priority
areas in the annual work plans and to base them on the needs and their EU added
value.

The case studies illustrate a clear linkage between the objectives
of the Health Programme and the
projects funded on one hand and how these projects may contribute to the
achievements of the objectives of the Programme on the other hand. However, the assessment of achievement of
objectives is hampered by lack of clear performance indicators.

It was also recommended to define clear performance indicators to
facilitate the follow-up and evaluation of the achievements and that progress
can be measured in terms of the achievement of the objectives. And, to ensure an effective implementation of the Health Programme,
it was recommended to develop a plan for long-term targets to be achieved by
the Programme. In conjunction with other policy implementation tools,
appropriate priority actions could then be set, financing mechanisms selected
and an appropriate spread among the objectives and priorities ensured.

The dissemination of the results of the Health Programme is seen as
another field where there is room for improvement and is directly linked to the
underlying logic: the outcomes of the action financed targeting health
policymaking at EU level, and also at national or regional levels, are not
sufficiently known and not recognised by national stakeholders and
policymakers. However, this is essential to ensure the sustainability of the
results and to help monitor the impact of the action under the Programme.

Thus both evaluations recommend that more effort is put in the
dissemination of the results obtained through different channels.

Summary of the Recommendations of the Court of Auditors:

These recommendations were in line with the findings of the
evaluations summarised above, they pointed out the following needs:

\* Any successor programme should be assigned better targeted
programme objectives which are in line with its budgetary means.

\* The underlying intervention logic should be stated in an
explicit manner, setting out SMART objectives at policy and programme
level, illustrating the links between them and defining indicators to measure
their achievement.

\* Mapping exercise in order to gain an overview of projects
undertaken and their results to identify the existing overlaps and any
remaining gaps in its portfolio.

\* The number of annual "actions areas" should be
significantly reduced and focused on strategic priorities.

\* Commission to address weaknesses in
project design and implementation by:

- bringing project objectives into line with programme objectives
and the refocused "annual priorities" recommended above;

- Grant agreements should establish not only which activities are
to be undertaken, but also the desired results of those activities, the
target groups and how the results will be used in a sustainable manner after
project completion;

- setting quantified targets and performance indicators wherever possible in order to facilitate monitoring of progress
towards objectives;

- evaluating projects ex-post in order
to improve the design of forthcoming projects (and putative successor
programmes) by applying "lessons learnt".

\* The Commission should fully exploit the existing Health Programme
(2008-2013) financial mechanisms for networks (i.e. operating grants)
since they are more suitable for such activities and service contracts
to carry out activities contributing to policy development. However this
requires more rigorous definition of Terms of Reference than in call for
proposals.

\* The Court
also recommends that "for the period after 2013, the European
Parliament, the Council and the Commission should reconsider the scope for EU
public health activities and the approach of EU funding in this area. This
should be done bearing in mind the budgetary means available and the existence
of other cooperation mechanisms (such as the open method of coordination) as a
means of facilitating collaboration and the exchange of information among
stakeholder throughout Europe".

6.5.4.
Coherence and possible synergy with other
relevant instruments

The Programme will promote synergies while avoiding duplication with
related Union programmes and actions. Appropriate use will be made of other
Union funds and programmes, in particular:

\* the current and future Union framework programmes for research and
innovation and their outcomes,

\* the Structural Funds,

\* the Programme for Social Change and Innovation

\* the European Solidarity Fund,

\* the European strategy for health at work,

\* the Competitiveness and Innovation Programme,

\* the Framework Programme for Environment and Climate Action (LIFE)

\* the programme of Union action in the field of consumer policy
(2014-2020)

\* the Justice programme (2014-2020),

\* the Union Statistical Programme within its respective activities,

\* the Ambient Assisted Living (AAL) Joint Programme.

\* the Education Europe Programme.

6.6.
Duration and financial impact

ý Proposal/initiative of limited
duration

–
ý  Proposal/initiative in effect from 01/01/2014 to 31/12/2020

–
ý  Financial impact from 2014 to 2023 in payment appropriations only

¨ Proposal/initiative of unlimited
duration

–
Implementation with a start-up period from YYYY
to YYYY,

–
followed by full-scale operation.

6.7.
Management mode(s) envisaged[21]

ý Centralised direct management by the Commission

ý Centralised indirect management with the delegation of implementation tasks to:

–
ý  executive agencies

–
¨  bodies set up by the Communities[22]

–
¨  national public-sector bodies/bodies with public-service mission

–
¨  persons entrusted with the implementation of specific actions
pursuant to Title V of the Treaty on European Union and identified in the
relevant basic act within the meaning of Article 49 of the Financial Regulation

¨ Shared management with the Member States

¨ Decentralised management with third countries

ý Joint management with international organisations (to be specified)

Comments

Executive
Agency for Health and Consumers (EAHC): In accordance with Council Regulation
(EC) No 58/2003 of 19 December 2002 laying down the statute for Executive
Agencies to be entrusted with certain tasks in the management of Community
programmes[23],
the Commission has entrusted[24]
the Executive Agency for Health and Consumers with implementation tasks for the
management of the second programme of Community Action in the field of health
for 2008-2013. The Commission may therefore decide to entrust an executive agency
also with implementation tasks for the management of the "Health for
Growth programme 2014-2020".

Joint
management with international organisations:

Envisaged to
develop cooperation with relevant international organisations such as the
United Nations and its specialised agencies, in particular the WHO, as well as
with the Council of Europe and the Organisation for Economic Cooperation and
Development, with a view to implementing the Programme through maximising the
effectiveness and efficiency of actions relating to health at Union and
international level, taking into account the particular capacities and roles of
the different organisations.

7.
MANAGEMENT MEASURES
7.1.
Monitoring and reporting rules

The Programme will be monitored on an annual basis in order to both
assess headway towards the achievement of its specific objectives against its
outcome and impact indicators and allow for any necessary adjustments of the
policy and funding priorities.

The Programme will be subject to mid-term term and ex-post
evaluation. A mid-term evaluation will aim at measuring progress made in
meeting the Programme objectives, determining whether its resources have been
used efficiently and assessing its European added value.

The ex-post evaluation of the current programme (2008 – 2013), which
is foreseen before the end of 2015, will also provide useful elements for the
implementation of the programme 2014 – 2020.

Specific information on the amount of climate related expenditure,
calculated in accordance with the Rio markers based methodology, as specified
in the June 2011 MFF Communication, will be included throughout the annual work
programmes, as well as within the evaluations at all levels and in the annual,
mid-term and ex-post reports.

7.2.
Management and control system
7.2.1.
Risk(s) identified

The budget implementation focuses on the attribution of grants and
service contracts.

The service contracts will be concluded in areas such as studies,
data collection, evaluation contracts, training, information campaigns, IT and
communication services, facilities management etc. The contractors are mainly health
institutions, laboratories, consultancy firms and other private companies of
which many SMEs. The average annual budget for contracts is estimated at some
EUR 14 million for approximately 30 contracts per year.

Grants will mainly be awarded for support activities to
non-governmental organisations, national agencies, universities etc. The period
of execution of the subsidised projects is usually between one and three years.
The average annual budget for grants is estimated at some EUR 37 million
for approximately 50 grants per year.

The main risks are the following:

\* Risk of poor quality of selected projects and poor technical
implementation of the project, reducing the programmes' impact; due to inadequate
selection procedures, lack of expertise or insufficient monitoring;

\* Risk of inefficient or non-economic use of funds awarded, both for
grants (complexity of reimbursing actual eligible costs coupled with limited
possibilities to check eligible costs at the desk) and for procurement
(sometimes limited number of economic providers with the required specialist
knowledge entailing insufficient possibilities to compare price offers);

\* Reputational risk for the Commission, if fraud or criminal
activities are discovered; only partial assurance can be drawn from the third
parties' internal control systems due to the rather large number of heterogeneous
contractors and beneficiaries, each operating their own control system, often
rather small in size.

7.2.2.
Control method(s) envisaged

The budget will be implemented by centralised direct management,
though parts of the implementation tasks of the programme might be delegated to
the existing executive agency EAHC. This agency set up its own internal control
system, is supervised by DG SANCO, and audited by the Commission's internal
auditor as well as the Court of Auditors.

DG SANCO and the EAHC alike put in place internal procedures that
aim at covering the risks identified above. The internal procedures are in full
compliance with the financial regulation and include cost-benefit
considerations. Within this framework, SANCO continues to explore possibilities
to enhance the management and to increase simplification. Main features of the
control framework are the following:

Characteristics of the selection process of projects: each call for proposals/tender is based on the annual Work
Programme adopted by the Commission. In each call, the exclusion, selection and
award criteria for selecting proposals/offers are published. Against these
criteria, an evaluation committee, possibly assisted by external experts, evaluates
each proposal/offer observing the principles of independence, transparency,
proportionality, equal treatment and non-discrimination. An Inter-service
Consultation on the selected proposals is carried out within the Commission to
prevent double funding.

External Communication strategy: DG
SANCO has a well developed communication strategy that seeks to ensure the
contractors'/beneficiaries' full understanding of the contractual requirements
and provisions. Following means are being used: EUROPA Programme website,
"frequently asked questions", a help desk, extensive guidance notes
as well as information meetings with beneficiaries/contractors.

\* Controls before and during the implementation of the projects:

- DG SANCO and the EAHC alike, use the model grant agreements and
service contracts recommended by the Commission. They provide for a number of
control provisions such as audit certificates, financial guarantees, on-site
audits as well as inspections by OLAF. The rules governing the eligibility of
costs will be simplified, for example, by using lump sums in a limited number
of cost categories. This will also help to better concentrate the checks and
controls. Partnership agreements are expected to improve the working relations
with the beneficiaries and to enhance the understanding of the eligibility
rules.

- All staff signs the code of good administrative behaviour. Staff
who are involved in the selection procedure or in the management of the grant
agreements/contracts also sign a declaration of absence of a conflict of
interest. Staff is regularly trained and uses networks to exchange best practices.

- Technical implementation of a project is checked at regular
intervals at the desk on the basis of technical progress reports of the
contractor; in addition contractors' meetings and on-site-visits are foreseen
on a case by case basis.

- Both SANCO's and EAHC's financial procedures are supported by the
Commission's IT tools and have a high degree of segregation of duties: all
financial transactions related to contracts/grant agreements are verified by
two independent persons before they are signed by the authorising officers
responsible for the activity. Operational initiation and verification is
carried out by different members of staff of the policy areas. Payments are
made on the basis of a number of pre-defined supporting documents such as approved
technical reports as well as verified cost claims and invoices. For a sample of
transactions, the central financial cell performs second-level ex-ante desk
verification; on a case by case basis, also an ex-ante on-site financial
control can be carried out prior to final payment.

\* Controls at the end of the project:

Both DG SANCO and the EAHC have  centralised audit teams who
verify on-the-spot the eligibility of cost claims. The aim of these controls is
to prevent, detect and correct material errors related to the legality and
regularity of financial transactions. With a view to achieving a high control
impact, the selection of contractors to be audited foresees to (a) combine
a risk based selection with a random sampling, and (b) pay attention to
operational aspects whenever possible during the on-site audit.

\* Costs and benefits of controls:

The programme's management and control measures are designed
on the basis of past experience: in the past three years, the established
internal control system ensured an average residual error rate of less than 2%
as well as compliance with the grant and procurement procedures laid down in
the financial regulation. These are the two main "control objectives"
of both the previous and the new public health programme.

As the main design features of the new programme are not
significantly different from the previous programme, the risks related to
programme implementation are considered to remain relatively stable. Thus, the
established management and control measures are planned to be continued;
nevertheless, further simplifications that might become possible under the new
financial regulation will be taken up as soon and as far as possible.

The total management costs included in the Financial Statement (part
3.2.3) amount to EUR 45,4 million for EUR 446,0 million of funds managed from
2014 to 2020; this leads to a ratio "management costs to managed
funds" of about 10.2 %, which should be viewed in the context of a policy
area which is not as spending-oriented as other EU policies.

Thanks to the combination of grants and procurement, risk based
ex-ante and ex-post controls as well as desk checks and on-site audits, the
"control objectives" will be achieved at a reasonable cost level. The
benefits of achieving an average residual error rate of less than 2% and
compliance with the provisions of the financial regulation are assessed as
sufficiently important to justify the chosen management and control measures.

7.3.
Measures to prevent fraud and irregularities

Specify existing or
envisaged prevention and protection measures.

In addition to the application of all regulatory control mechanisms,
DG SANCO will devise an anti-fraud strategy in line with the Commission's new
anti-fraud strategy (CAFS) adopted on 24 June 2011 in order to ensure inter
alia that its internal anti-fraud related controls are fully aligned with the
CAFS and that its fraud risk management approach is geared to identify fraud
risk areas and adequate responses. Where necessary, networking groups and
adequate IT tools dedicated to analysing fraud cases related to the public
health programme will be set up in particular a series of measures such as:

- decisions, agreements and contracts resulting from the
implementation of the Health Programme will expressly entitle the Commission,
including OLAF, and the Court of Auditors to conduct audits, on-the-spot checks
and inspections;

- during the evaluation phase of a call for proposals/tender, the
proposers and tenderers are checked against the published exclusion criteria
based on declarations and the Early Warning System (EWS);

- the rules governing the eligibility of costs will be simplified in
accordance with the provisions of the Financial Regulation;

- regular training on issues related to fraud and irregularities is
given to all staff involved in contract management as well as to auditors and
controllers who verify the beneficiaries' declarations on the spot.

8.
ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE
8.1.
Heading(s) of the multiannual financial
framework and expenditure budget line(s) affected

· Existing expenditure budget lines

In the order of
multiannual financial framework headings and budget lines:

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number || Diff./non-diff ([25]) || from EFTA[26] countries || from candidate countries[27] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

3: security and citizenship || 17 03 06 EU action in the field of health || Diff. || YES || YES || NO || NO

3: security and citizenship || 17 01 04 Programme of European Union action in the field of Health – expenditure on administrative management || Non-diff. || YES || YES || NO || NO

No new
budget lines requested.

8.2.
Estimated impact on expenditure
8.2.1.
Summary of estimated impact on expenditure

EUR million (to 3 decimal places) in
current prices

Heading of multiannual financial framework: || Number 3 || Security and citizenship

DG: SANCO || || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || Subsequent years || TOTAL

Operational appropriations || || || || || || || || ||

17 03 06 || Commitments || (1) || 54.465 || 56.281 || 57.188 || 58.096 || 59.004 || 60.819 || 59.004 || || 404.857

Payments || (2) || 5.000 || 16.000 || 32.000 || 49.000 || 54.000 || 57.000 || 57.000 || 134.857 || 404.857

Appropriations of an administrative nature financed from the envelope for specific programmes[28] ||

17 01 04 || || (3) || 5.535 || 5.719 || 5.812 || 5.904 || 5.996 || 6.181 || 5.996 || || 41.143

TOTAL appropriations for DG SANCO || Commitments || =1+1a +3 || 60.000 || 62.000 || 63.000 || 64.000 || 65.000 || 67.000 || 65.000 || || 446.000

Payments || =2+2a +3 || 10.535 || 21.719 || 37.812 || 54.904 || 59.996 || 63.181 || 62.996 || 134.857 || 446.000

Ÿ TOTAL operational appropriations || Commitments || (4) || 54.465 || 56.281 || 57.188 || 58.096 || 59.004 || 60.819 || 59.004 || || 404.857

Payments || (5) || 5.000 || 16.000 || 32.000 || 49.000 || 54.000 || 57.000 || 57.000 || 134.857 || 404.857

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || 5.535 || 5.719 || 5.812 || 5.904 || 5.996 || 6.181 || 5.996 || || 41.143

TOTAL appropriations under HEADING 3 Security and citizenship || Commitments || =4+ 6 || 60.000 || 62.000 || 63.000 || 64.000 || 65.000 || 67.000 || 65.000 || || 446.000

Payments || =5+ 6 || 10.535 || 21.719 || 37.812 || 54.904 || 59.996 || 63.181 || 62.996 || 134.857 || 446.000

The Commission could envisage externalising
the implementation of the Health for Growth programme to an executive agency. Amounts
and breakdown of estimated costs may have to be adjusted according to the
degree of externalisation finally retained.

.

EUR million (to 3 decimal places) in current prices

Heading of multiannual financial framework: || 5 || " Administrative expenditure "

|| || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || TOTAL

DG: SANCO ||

Ÿ Human resources SANCO (17 01 01) || 1.088 || 1.110 || 1.132 || 1.155 || 1.178 || 1.202 || 1.226 || 8.091

DG: SANCO ||

Ÿ Other administrative expenditure (17 01 02 11) || 2.125 || 2.168 || 2.211 || 2.255 || 2.300 || 2.346 || 2.300 || 15.705

TOTAL DG SANCO || Appropriations || 3.213 || 3.278 || 3.343 || 3.410 || 3.478 || 3.548 || 3.526 || 23.796

TOTAL appropriations under HEADING 5 of the MFF || (Total commitments = Total payments) || 3.213 || 3.278 || 3.343 || 3.410 || 3.478 || 3.548 || 3.526 || 23.796

|| || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || TOTAL

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || 63.213 || 65.278 || 66.343 || 67.410 || 68.478 || 70.548 || 68.526 || 469.796

Payments || 13.748 || 24.997 || 41.155 || 58.314 || 63.475 || 66.729 || 66.522 || 334.939

8.2.2.
Estimated impact on operational appropriations

–
¨  The proposal/initiative does not require the use of operational
appropriations

–
ý  The proposal/initiative requires the use of operational
appropriations, as explained below:

–
Commitment
appropriations in EUR million in current prices (to 3 decimal places)

Indicate objectives and outputs ò || || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || TOTAL

OUTPUTS

Type of output || || Nb of outputs || Cost || Nb of out puts || Cost || Nb of outputs || Cost || Nb of outputs || Cost || Nb of outputs || Cost || Nb of outputs || Cost || Nb of outputs || Cost || Total number of outputs || Total cost

SPECIFIC OBJECTIVE No 1 || 3 || 26.143 || 7 || 27.015 || 11 || 27.450 || 11 || 27.886 || 11 || 28.322 || 11 || 29.193 || 11 || 28.322 || 65 || 194.331

SPECIFIC OBJECTIVE No 2 || 2 || 11.982 || 4 || 12.382 || 6 || 12.581 || 6 || 12.871 || 6 || 12.981 || 6 || 13.380 || 6 || 12.981 || 36 || 89.069

SPECIFIC OBJECTIVE No 3 || 2 || 11.438 || 5 || 11.819 || 8 || 12.010 || 8 || 12.200 || 8 || 12.391 || 8 || 12.772 || 8 || 12.391 || 47 || 85.020

SPECIFIC OBJECTIVE No 4 || 1 || 4.902 || 3 || 5.065 || 5 || 5.147 || 5 || 5.229 || 5 || 5.310 || 5 || 5.474 || 5 || 5.310 || 29 || 36.437

TOTAL COST || 9 || 54.174 || 19 || 55.980 || 30 || 56.882 || 30 || 57.785 || 30 || 58.688 || 30 || 60.494 || 30 || 58.688 || 178 || 404.857

Outputs expected in 2021 and 2022:
objective 1: 12; objective 2: 6; objective 3: 9; objective 4: 6 thus 32 for the
whole programme. In total, in indicative total of 210 outputs are expected.

Outputs consist in:

specific objective 1: number of tools and mechanisms developed;

specific objective 2: number of functioning European Reference
Networks and number of guidelines developed;

specific objective 3: number of validated best practices for cost
effective prevention measures identified and disseminated;

specific objective 4: number of common approaches (towards cross
border health threats) developed.

The split per year is an average and is
purely indicative as it is the split for the total envelope that is more
significant for the programme. Indeed, it may well be that one year more
efforts are put on one specific objective than the other. Orientations for
annual spending will be given in a multi-annual strategic programming. The
final decision will be taken when preparing the annual work programme.

8.2.3.
Estimated impact on appropriations of an
administrative nature
8.2.3.1.
Summary

–
¨  The proposal/initiative does not require the use of administrative
appropriations

–
ý  The proposal/initiative requires the use of administrative
appropriations, as explained below:

EUR million in 2011 prices (to 3 decimal
places)

|| 2014 || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || TOTAL

HEADING 5 of MFF

Human resources (BL 17 01 01) || 1.026 || 1.026 || 1.026 || 1.026 || 1.026 || 1.026 || 1.026 || 7.182

Other administrative expenditure (BL 17 01 02 11) || 2.025 || 2.025 || 2.025 || 2.025 || 2.025 || 2.025 || 2.025 || 14.175

Subtotal HEADING 5 of the MFF || 3.051 || 3.051 || 3.051 || 3.051 || 3.051 || 3.051 || 3.051 || 21.357

Outside HEADING 5 of the MFF

Administrative expenditure in support of the programme (BL 17 01 04) || 5.320 || 5.320 || 5.320 || 5.320 || 5.320 || 5.320 || 5.320 || 37.240

Subtotal outside HEADING 5 of the MFF || 5.320 || 5.320 || 5.320 || 5.320 || 5.320 || 5.320 || 5.320 || 37.240

TOTAL || 8.371 || 8.371 || 8.371 || 8.371 || 8.371 || 8.371 || 8.371 || 58.597

8.2.3.2.
Estimated requirements of human resources

–
¨  The proposal/initiative does not require the use of human
resources

–
ý  The proposal/initiative requires the use of human resources, as
explained below:

Number of posts in FTEs

|| 2014 || 2015 || 2016 || 2017 || 2018 || 2019 || 2020

· Establishment Plan Posts (officials and temporary agents) SANCO

17 01 01 01 - at headquarters and in Commission representation offices in Member States (AD &AST) || 5.7 || 5.7 || 5.7 || 5.7 || 5.7 || 5.7 || 5.7

2.375 || 2.375 || 2.375 || 2.375 || 2.375 || 2.375 || 2.375

Total establishment plan posts SANCO || 8.075 || 8.075 || 8.075 || 8.075 || 8.075 || 8.075 || 8.075

TOTAL || 8.075 || 8.075 || 8.075 || 8.075 || 8.075 || 8.075 || 8.075

The human resources required will be met by staff from the DG who are
already assigned to management of the action and/or have been redeployed within
the DG, together if necessary with any additional allocation which may be
granted to the managing DG under the annual allocation procedure and in the
light of budgetary constraints.

Description of
tasks to be carried out:

Officials and temporary agents || In SANCO: Elaboration of programme, multi-annual work programme, annual work programmes, follow-up of implementation of the programme, evaluation, audits, etc. Coordination with the executive agency if an externalisation of the management of the Programme is eventually decided.

8.2.4.
Compatibility with the current multiannual
financial framework

–
ý  Proposal/initiative is compatible with the 2014–2020 multiannual
financial framework as proposed in Commission's Communication COM(2011)500.

–
¨  Proposal/initiative will entail reprogramming of the relevant
heading in the multiannual financial framework.

–
¨  Proposal/initiative requires application of the flexibility
instrument or revision of the multiannual financial framework[29].

8.2.5.
Third-party contributions

–
ý The proposal/initiative does not provide for co-financing by third
parties

–
¨ The proposal/initiative provides for the co-financing estimated
below:

8.3.
Estimated impact on expenditure

–
ý  Proposal/initiative has no financial impact on revenue.

–
¨  Proposal/initiative has the following financial impact:

[1]               COM(2011)500 Final.

[2]               COM(2010)2020 Final.

[3]               Source:
extracted from Eurostat
online database in July 2011 ‘General expenditure
by function - health compared to total’. 2009: 14.63 %; http://appsso.eurostat.ec.europa.eu/nui/show.do?dataset=gov\_a\_exp&lang=en
.

[4]               IMF 2011 and Joumard et al., 2010, i.e. the rise in
public health spending over GDP in excess of what is due to population ageing
(this excess cost growth is estimated at an average of about 1 % for the
OECD).

[5]               Directive 2011/24/EU of
the European Parliament and the Council of 9 March 2011

[6]               OJ C , , p. .

[7]               OJ C , , p. .

[8]               Communication from the Commission, COM (2010) 2020
final

[9]               OJ L 271, 9.10.2002, p. 1-12

[10]             OJ L 301, 20.11.2007, p. 3-13

[11]             Court of Auditor's Special Report n°212009 of 5.3.2009,
"The European Union's Public Health Programme (2003-2007): an effective
way to improve health?"

[12]             The European Centre for Disease Prevention and Control was
established by Regulation (EC) 851/2004 of the European Parliament and of the
Council.

[13]             The Scientific Committees were
set up in accordance with Commission Decision 2008/721/EC, OJ reference

[14]             OJ L, ,p.

[15]             OJ L 248, 16.9.2002, p. 1.

[16]             OJ L 55, 28.2.2011, p 13.

[17]             COM (2010) 546 final

[18]             OJ L 88, 4.4.2011, p. 45.

[19]             OJ L 88, 4.4.2011, p. 45.

[20]             As referred to in Article 49(6)(a) or (b) of the
Financial Regulation.

[21]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag\_en.html

[22]             As referred to in Article 185 of the Financial
Regulation.

[23]             OJ L 11, 16.1.2003, p. 1.

[24]             Commission Decision C(2008)4943 of 9 September 2008.

[25]             Diff. = Differentiated appropriations / Non-Diff. =
Non-differentiated appropriations

[26]             EFTA: European Free Trade Association.

[27]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.

[28]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions (former
"BA" lines), indirect research, direct research.

[29]             See points 19 and 24 of the Interinstitutional
Agreement.

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