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# 52011SC1323

**COMMISSION STAFF WORKING PAPER Executive summary of impact assessment Accompanying the documentHealth for growth programme of EU action in the field of health for the period 2014-2020 /\* SEC/2011/1323 final \*/**

  

Disclaimer

This Impact Assessment report commits only the Commission’s services
involved in its preparation and the text is prepared as a basis for comments
and does not prejudge the final form of any decision to be taken by the
Commission.

1.
PROBLEM DEFINITION

‘Health for Growth’
the third EU Programme in the area of Health for the period 2014-2020 (hereinafter
the ‘Programme’), will seek to build on the results achieved by both the first Public
Health Programme (PHP) for 2003-2007 and the current, second Health Programme
(HP) for 2008-2013.

However, in line with the
objectives of ‘Europe 2020: A European strategy for smart, sustainable and
inclusive growth’[1]
and based on the conclusions drawn and recommendations made in the different
evaluations and audit exercises performed on the previous programmes, the new
Programme will also introduce a new approach in certain respects. It will be a
more focused programme, concentrating on a more limited number of high-profile
priorities and activities where it can build up a critical mass, inter alia
by exerting a leverage effect, complementing Member States' policies and encouraging
cooperation in the area of health, in accordance with Article 168 of the Treaty
on the Functioning of the European Union.

Lessons learnt from
the previous programmes and their evaluations were unequivocal:

a) The new Programme should contain less and have more focused
objectives and concentrate its financial support on a smaller number of
activities in key priority areas, bringing the greatest EU added value.
It should increase efficiency gains and maximise the impact of the
Programme;

b) The Programme should better involve
all participating countries, especially those EU Member States with
relatively low Gross National Income (GNI).The emphasis should be placed on
areas where they cannot act in isolation in a cost-effective manner,
where there are clear cross-border or internal market issues or where there are
significant advantages and efficiency gains from collaboration at EU level.

c) The results need to be built into a
regular reporting system and shared/spread more efficiently between
Commission departments and with stakeholders and national policymakers.

As stated in the European Commission's Communication of
29 June 2011 ‘A budget for Europe 2020’[2]
‘Promoting
good health is an integral part of the smart and inclusive growth objectives of
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’.

More particularly in the related policy fiche on Health of the
Multi-annual Financial Framework (MFF) Communication it is stated:

"The new Health for Growth Programme will be oriented
towards actions with clear EU added-value, in line with the Europe 2020
objectives and new legal obligations. The principal aim is:

to work with Member states to protect citizens from
cross-border health threats,
to increase the sustainability of health services,
to improve the health of the population, whilst encouraging
innovation in health.

For example, the programme will support health policy by developing
best practices and guidelines for the diagnosis and treatment of rare
diseases, supporting European reference networks on diseases,
developing best practices and guidelines for scanner screening
and developing a common EU approach to health technology assessments and
e-Health.

[In the same time] Research and innovation actions in the area of
health will be supported under the Common Strategic Framework for Research and
Innovation".

In this Communication the
Commission proposed an allocation of 396 million euros (in 2011 prices; or 446
million euros in current prices) for the period 2014-2020 for a dedicated
expenditure programme in the area of health. In budgetary terms this is
undeniably a small to medium size programme, especially when taking into
account that health care expenditure accounts for
nearly 10 % of the EU’s gross domestic product and is one of the largest
economic sectors in the EU.

Health is not just a value in itself - it is also a
strong economic driver for growth. The healthcare sector employs one in ten
workers in the EU who are among the most qualified because there is a higher
than average proportion of workers with tertiary-level education. This weight
gives the healthcare sector an important role to play in the economy in general
and in contributing to the Europe 2020 Strategy. There is strong evidence of
the link between health and economic performance: a population in good health
is a sine qua non for attaining smart, sustainable and inclusive growth.

Not only is good health one of the most important factors for
increasing individual productivity and citizen empowerment, but also an
increase in the number of productive years as a result of better health would
have an immediate positive impact on collective productivity and
competitiveness. In addition, health is a strong economic driver of growth, both
by sustaining household demand and by increasing savings, as well as by
creating high quality jobs, stimulating innovation and providing a basis for a
strong European industry.

Finally, investing in health can also help address the challenges as
well as better exploit the opportunities offered by an ageing society (over the next 20 years, the number of
Europeans aged over 65 is expected to rise by 45%, from 85 million in 2008 to
123 million in 2030). Issues arising in this
context are related not only to protecting, promoting and improving the health
status of the elderly, but also to financing the rising healthcare costs and to
improving the healthcare offered, in response to higher and different expectations,
and also ensuring access to it.

In
the area of health the Member States are under pressure to strike the right
balance between providing universal access to high quality health services and
respecting budgetary constraints. These problems are not necessarily new, but the
need to tackle them has become more and more urgent, particularly in the
current economic climate. The financial crisis has further magnified the need
to improve cost-effectiveness of national health systems. First and foremost it
is up to Member States to take direct action at their 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
challenge is to build an EU Health Programme that serves the best the interests
of Member States and other stakeholders within a limited budget. It is
therefore necessary to prioritise needs in such a manner that results of the
Programme are used and create a leverage effect to support and develop health
policies at European, national and local level.

The Programme should provide 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. It should bring the biggest EU added value and lead to economies of
scale, thus supporting reforms under challenging circumstances. There are several challenges that Member States and the EU as a whole are facing from the 2020 perspective and beyond:

A.
Financial sustainability of health systems;

            B. Health workforce shortages;

            C. Improvements necessary in patient safety;

            D. Lack of sustained progress on control and prevention
of chronic conditions;

            E. Loss of best productive years in much of the population
because of the slow increase in healthy life years;

            F. Increasing inequalities in health throughout Europe and in its neighbourhood;

            G. Global and cross-border threats.

The Programme can contribute to addressing the above-mentioned
challenges only to the extent that it offers financial opportunities to build
and strengthen cooperation mechanisms and coordination processes between Member
States with a view to identifying common tools and best practices that would
create synergies, bring EU added value and lead to economies of scale, while
fully respecting the principle of subsidiarity and recognizing the ultimate
responsibility of Member States to take decisions most suited to their specific
situations

Thus, the Programme will contribute only where Member States could
not act individually or where coordination is clearly the best way to move
forward. In line with the EU 2020 objectives, the action taken in the Programme
must prove to have real EU added value and a measurable impact.

Also other better resourced EU funding programmes will contribute to
improving public health in the EU, most notably the public health component of
the Research Programme and of the Structural Funds. However, the Health Programme
is the only one aiming specifically at addressing the challenges and concerns in
the health policy field, while also enabling further achievement of the policy
goals in this area. It can therefore address issues that are out of the scope
of other funding programmes. Its success can nonetheless be amplified by forging
the necessary links and clear synergies with other spending programmes.

2. SUBSIDIARITY TEST – THE RIGHT OF
THE EUROPEAN UNION TO ACT

Article 168 of the Treaty on the Functioning
of the European Union (TFEU) strongly asserts the principle of
subsidiarity in public health. It says that ‘Union
action … shall complement the national policies’ and then that ‘Union
action shall complement the Member States’ action.’ The Union can also ‘lend support to their action’.

The main areas where this complementary action has to be
taken are also mentioned:

·
improving public health,

·
preventing physical and mental illness and
diseases,

·
obviating sources of danger to physical and
mental health,

·
fighting against the major health scourges,

·
reducing drugs-related health damage, including
information and prevention, and

·
improving the complementarity of the Member
States’ health services in
cross-border areas.

The same article also indicates ways to contribute to
the fight against major health scourges:

·
promoting research into their causes, their
transmission and their prevention,

·
promoting health information and education,

·
monitoring, early warning of and combating
serious cross-border threats to health,

·
encouraging cooperation between the Member
States. In particular, 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.’

Paragraph 3 of the same article then goes on to say 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 to protect
and improve human health.

Necessity test

While Member States as sovereign entities have to tackle the
above-mentioned problems and decide on their national health policies, in a
number of cases they can only take action after coordination at EU level. For many
countries, the cooperation between Member States is very beneficial and is far
more cost-effective. There is also a better chance of solving global issues and
common concerns by mobilising efforts at EU level and establishing common
values and principles.

The Programme will therefore primarily fund actions that cannot be carried
out as effectively by Member States on their own but depend greatly on
cooperation at EU level.

3. EU ADDED VALUE

Experience from past
programmes has provided a number of examples where action at EU level can
provide clear added value that has been recognised by the Member States (cf.
case studies annexed to the Impact Assessment).

The value of investing
in preparedness, prevention and coordination of measures on health threats and
communicable diseases at EU level was clearly demonstrated recently by the H1N1
outbreak in 2009. Strengthening the capacity to manage serious cross-border
health threats, along with joint procurement of vaccines against pandemics, is another
area where significant EU added value can be obtained. Cooperating
on cross-border diseases such as H1N1 flu also cannot be undertaken by
individual Member States, but depends on initiatives and funding at EU level.
In the area of health threats, the EU’s role, beyond coordinating the response
to these threats, is also to enhance the capacity of Member States and non-EU countries to respond to them. Providing a rapid and coordinated answer to
global health threats is also the EU’s role.

The EU can also deliver
significant benefits on issues such as cross-border health care and health
inequalities and by developing strategies to counter growing antimicrobial
resistance, along with cost-effective health technologies and innovative
healthcare, and promoting healthy ageing with the aid of a European Innovation
Partnership. Action under the Health Programme
complements and adds value to Member States’ action on health promotion and
prevention of illness (including work on, for example, nutrition and smoking
and on reducing inequalities in healthcare), protection of citizens against
health threats, in particular pandemic preparedness, the safety of medical
products, blood, tissues, cells and organs, and cooperation between health
systems. Understanding rare diseases and developing innovative treatment for
them requires pooling of patient populations in European registers across
several countries; many such measures depend critically on the Health
Programme.

The
Health Programme has developed and strengthened networks between European
health specialists, national and regional health authorities and other
stakeholders who greatly contribute to sharing knowledge and building health
capacity in the EU. It has also built consortia, partnerships and other ways to
exchange information and practices across Europe, thus boosting cooperation and
the pace of research. The outcome of the projects and action funded by the
Health Programme constitute the most effective, if not the only, way to build
the evidence base for defining much broader regulatory policies (for instance,
on cancer, Alzheimer’s, rare diseases and health inequalities).

In the context of the mid-term evaluation of the 2nd
Health Programme and based on the in-depth analysis of the case studies
following EU added value criteria were developed and tested regarding concrete
funded actions:

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 related 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 for
decision-making;
Improving economies of scale by avoiding waste due to
duplication and optimising use of financial resources.
4. OBJECTIVES OF THE PROGRAMME

Taking into
consideration the problems and context described above, as well as limited
financial resources in the coming years, the ‘Health for Growth’ Programme general
objectives 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.

.
The specific objectives underpinning the logic of the
Programme are all outcome-oriented and put the emphasis on the practical
results and their up-take by Member States in their national programmes and
health policies in order to exert leverage on health action
and across other policies and other EU funding programmes:

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

By supporting Member States' efforts to improve the
efficiency and financial sustainability of health care, EU Health Programme
aims at encouraging a shift of significant resources in this sector on 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. Health system reform
must clearly consist of a mix of immediate efficiency gains with longer term strategic action addressing key
cost drivers. This is the only way if countries are to ensure universal access
and equity in health, health financing and use of the system. As an example,
European cooperation on health technology assessments will not only
reduce duplication and pool expertise but can unlock the potential for
sustainable innovation in health products and services.

It is of utmost importance to 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 and tools.

The EU 2020 strategy identifies innovation as a key to creating
smart growth. There is a huge "smart growth" potential in health
which can lead to increased efficiency and the creation of new health
interventions and products adapting to our society. Innovation
responds to the sustainability challenge facing health systems both by fostering
completely novel solutions to answer unmet needs and by deploying more
efficiently what is already available and creating the right conditions for
future innovation. Innovation should be seen not only as technology-based but
also as organisational and social, centred on the human factor, so that it can
bring genuine benefits in a cost-effective way.

The recent economic crisis has rendered the need to improve the
cost-effectiveness of health systems even more pressing and has turned it into
a top policy priority that is likely to remain on the agenda for many years to
come. Member States will have to balance the need to provide access for all
against the increasing demand for quality health services at a time of
constrained resources.

The cost-effective use of medical technologies, including the
upcoming therapies based on genomic science, an adequate supply of health
professionals, expertise necessary to improve decision-making, as well as
support for the European Innovation Partnership on Active and Healthy Ageing are
the areas where the Programme could play an important role under this policy
objective by taking a very pragmatic approach.

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 to all citizens regardless of income,
social status, location and nationality is a 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. It is also
recognized that health is a key driver of inequalities, as poor health status
often has a substantial impact on accessibility to effective health care and
the possibilities of individual citizens to act on health information
disseminated at national and European level. Action under all the objectives of
the programme should help contribute to bridging such inequalities by addressing
various health factors that give rise to and increase inequalities, as well as
complement action under other programmes specifically 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 European centres of reference accessible to all citizens across
the EU.

Scarce knowledge can be shared and resources combined as efficiently
as possible across the EU, as can be seen, for instance, in the case of rare
diseases.[3]
Under specific objective 2, this sharing of resources is to be expanded to
other areas of health requiring a particular concentration of resources or
expertise to look at various clinical conditions. The main goal here is to pool
medical expertise and knowledge in order to improve access to diagnosis and
provision for all patients requiring highly specialised care for a specific
disease or group of diseases.

Such networks would add to the already substantial expertise and
capacity for specific complex/high-tech diagnostic or treatment services of the
centres participating, offering significant added value in the form of improved
quality and cost-effectiveness spread throughout the continuum of care.

The ultimate aim would be to improve patients’ health by increasing
cross-border possibilities. This would also help Member States with empowering
patients, by increasing the availability of information and transparency on
care delivery which, in turn, would help to achieve better healthcare outcomes.

Specific actions under this policy objective would include setting
up accreditation and support of European reference networks, strengthening
collaboration on patient safety and quality of care and improve the prudent use
of antimicrobial agents in human medicine.

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 promoting good health

Prevention of diseases and promotion of health contribute to increasing
the number of ‘healthy life years’ or years in good health. Apart from the fact
that health is the greatest wealth and a goal per se, healthy citizens
contribute to economic prosperity by virtue of their higher labour market
participation and productivity. Well-directed investment to promote health and
prevent diseases is one of the most cost-effective means of stimulating growth
in gross domestic product. This is becoming extremely crucial in the context of
an ageing society and longer working lives.

The right investments
will not only lead 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 lack of skilled
labour.

The Programme
foresees action to support the efforts of Member States aimed at prolonging the
healthy and productive life years in the areas of cost-effective promotion and
prevention measures addressing risk factors and underlying health determinants,
chronic diseases and cancer.

4. Developing common approaches and demonstrate 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 co-ordinating the preparedness and response for serious cross border
health threats is enshrined in the Treaty. By their
very nature, such health threats are not confined to national borders and
cannot be effectively addressed by any Member State alone. The EU needs to be well
prepared against these threats which can have a high impact not just on the
health and life of citizens, but also on the economy.

In
order to minimise the public health consequences of 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), robust mechanisms and tools to
detect, assess and manage major cross-border health threats need to be
established or reinforced. Due to the nature of these threats, coordinated
public health measures at EU level are needed to address different aspects,
building on preparedness and response planning, robust and reliable risk
assessment and on a strong risk and crisis management framework.

The
overriding aim is to tighten up the monitoring, the early warning system and
the fight against serious cross-border health threats, also in the light of the
‘one health’ concept and with a view to the comprehensive framework on health
security that is currently being developed.

In this
context, the future Health for Growth Programme would support implementation of
the EU legislation on health threats and EU action in the field of public
health crisis management. All the components of crisis management will be
addressed: preparedness and response planning, risk and crisis communication,
capacity-building for risk assessment and training, exchanges of experience and
best practice in handling health emergencies. The action envisaged ranges from
supporting development of Member States’ core capacity and standards for
preparedness to response planning.

This capacity-building covers surveillance, detection and risk
assessment for major health scourges, on the basis of the legislation being
reviewed and developed, together with multinational, cross-sectoral training
activities and initiatives for prevention and control of communicable diseases,
antimicrobial resistance and hospital-acquired infections, plus improvements in
vaccination policies and strategies at EU level.

5. POLICY OPTIONS

Option 1 corresponds to
the absolute minimum of actions resulting from the legal obligations imposed by
the Treaty and the existing EU acquis in the field of medicinal
products, medical devices, substances of human origin, patients rights in cross
border healthcare, Health security (cross border health threats) and tobacco.

Option 2 corresponds to
the baseline scenario. It implies continuing the programme in its present form
with no changes consequently to the findings of the evaluations, in addition to
the direct legal obligations.

Option 3, sub-option A
corresponds to a well structured programme, with SMART objectives, prioritised
actions, creating EU added value and with better monitoring of outcomes and
impacts. It will be focused on:

·
supporting actions required by the current EU
health and internal market legislation,

·
supporting the up-take of innovative solutions
for improving specific points concerning the quality, efficiency and
sustainability of health systems,

·
prevention of diseases at EU level by helping
and complementing Member States’ efforts to increase their citizens’ number of
healthy life years (HLY), including the aspect of reduction of health
inequalities but mainly by other means than the resources of the Programme and
limited to development of working methods and policy evaluation;

·
supporting and complementing Member States
efforts in protecting citizens from cross border health threats.

Sub-option 3, sub-option B corresponds to a well structured programme but dealing only with
one of the general objectives as a trade off. This programme would be focused
on:

·
supporting actions required by the current EU
health and internal market legislation,

·
supporting the up-take of innovative solutions
for improving specific points concerning the quality, efficiency and
sustainability of health,

·
supporting and complementing Member States
efforts in protecting citizens from cross border health threats.

Sub-option 3, sub-option C corresponds to a programme limited to supporting actions required
by the current EU health and internal market related legislation and to support
and complementing Member States efforts in protecting citizens from cross
border health threats. In addition, there would be some dissemination of the
results of the current Health Programme in order to take into account the
conclusions of previous evaluations,

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

6. Comparison of the options

The option
involving no resources at all was not considered. Without credits the
Commission would simply not be able to fulfil its obligations stemming from the
existing legislation.

Option 1 would cause a reduction of EU support to Public Health policy, as
well as contravene the conclusions of the evaluation of the current Health
programme and the requests for a continuation of the programme made by the EU
Health ministers and other stakeholders. It would fail to guarantee an adequate
support to the future Public Health policy.

Option 2 would allow taking into account to a certain degree concerns of
Member States and stakeholders' and it would have leverage on national health
policies. However, in the absence of intervention logic, lack of SMART,
realistic objectives, with a large number of actions not prioritised and no precise
indicators to measure the achievements, any kind of impact would first be very
difficult to assess and then very limited, because not part of a logic. This
type of programme would not allow to achieve the objectives and it would not
take into account the recommendations stemming from the past evaluations and
audits.

Option 3, sub-option A will allow the
specific objectives to be achieved through the actions defined and prioritised
in this impact assessment. The Commission's legal obligations would be
fulfilled. The proposed Programme would address the main criticisms made by the
external evaluations and in the Court of Auditors report. It would have intervention
logic, well defined policy objectives, SMART, realistic, outcome oriented and
pragmatic specific objectives, actions to be carried out would be prioritised with
the help of specific EU added value criteria and a set of indicators would be
defined for measuring the outcomes and up-take of Programme results by Member States.
Thus, it would be possible to measure achievements and to act if they are not
in line with milestones established and, finally, to determine the impact of
the Programme.

Option 3, sub-option B corresponds to a
lower budget than the current programme and the allocation foreseen in the MFF
Communication. This option would not allow addressing satisfactorily the
challenges faced in public health as the synergies between promotion of good
health and chronic diseases would be lost, especially regarding citizens'
exposure to chronic diseases. The programme would not respond to the
expectations of Member States and other stakeholders.

Option 3, sub-option C corresponds
merely to option 1 but with the specific objective on health threats. While
Commission's legal obligations would be fulfilled and while actions on health
threats would be carried out, all the other actions at EU level would be
discontinued. This would cause a reduction of EU support to Public Health
policy, as well as contravene the conclusions of the evaluation of the current
Health programme and the request for a continuation of the programme made by
the stakeholders and the MS. It would fail to guarantee an adequate support to
the future Public Health policy currently under preparation.

Option 4 means a substantial increase of the Public Health budget which is
not realistic.

The result of the comparison of the
option was unequivocal: the option 3A is by far the one preferred.

7. Monitoring and evaluation

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.

At the request of the Commission, without disproportionate increase
in the administrative burden, the Member States should submit any available
information on the implementation and impact of the Programme.

The proposal is to set up an indicative internal multi-annual work programme
- it would serve as a guideline for the annual work plans.

A wide range of financial mechanisms will be used in the Programme:
calls for proposals, grants for actions with Member States, grants for
international organisations, operating grants and public procurement contracts.
As said in the evaluations, the experience gained from their introduction in
the current Health Programme was positive and considered as an improvement over
the system for the previous Public Health Programme.

The Programme will be subject to mid-term
term and ex-post evaluation. The mid-term evaluation
will serve the impact assessment exercise for eventual follow-up programme in
the area of health post-2020.

[1] Communication from the Commission:
‘Europe 2020 — A strategy for smart, sustainable and inclusive growth’
COM(2010) 2020 final.

[2] ‘A Budget for Europe 2020’ —
Communication from the Commission to the European Parliament, the Council, the
European Economic and Social Committee and the Committee of the Regions —
COM(2011) 500 final.

[3] See Annex
7 for case studies on European reference networks for rare diseases and
ORPHANET.

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