EUROPEAN COMMISSION 
Brussels, 9.11.2011 
SEC(2011) 1322 final 
  
COMMISSION STAFF WORKING PAPER 
Impact assessment 
Accompanying the document 
Proposal for a  
 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
establishing a Health for Grow th Programme, the third progr amme of EU action in the 
field of health for the period 2014-2020 
{COM(2011) 709 final} 
{SEC(2011) 1323 final}  
 
 1Contact : Irène Athanassoudis: 36572 ─ Myriam Cazzaniga: 35093 
    Introduction ................................................................................................................... ...................3 
1.  Procedural issues and consu ltations with third parties.........................................................4 
1.1.  Organisation and timing.................................................................................................. .4 
1.2.  Expertise and consultations.............................................................................................. 4 
1.3 Impact Assesment Board's comments:...................................................................................7 
2.  Problem definition......................................................................................................... .......8 
2.1.  Policy context........................................................................................................... ........8 
2.2.  Defining the problem and its causes and effects ..............................................................9 
3.  The Policy Objectives ...................................................................................................... ..15 
3.1. Policy objective 1: Contributi ng to innovative, efficient and sustainable health systems
 15 3.2. Policy objective 2: Increasing access to better and safer healthcare for EU citizens.....19 3.3. Policy objective 3: Promoting good health and preventing diseases to improve citizens' 
health 21 3.4. Policy objective 4: Protecting citizens from cross-border health threats.......................22 
3.5. Horizontal activities ..................................................................................................... ..23 
3.6. Context of the Programme .............................................................................................27 3.7.  Link between health challenges, MFF announcements, policy objectives, specific 
objectives and Programme actions.............................................................................................27  
4. Subsidiarity test – the right of the European Union to act .....................................................32 
4.1. Legal basis............................................................................................................... .......32 
4.2.  Necessity test........................................................................................................... .......32 
4.3. EU added value ............................................................................................................ ..34 
5. Links between the Health for Growth Programme and the EU 2020 Strategy ......................38 
5.1. Provide innovative solutions for improving th e quality and sustainability of health 
systems ........................................................................................................................ ...............38 
5.2. Support and complement the efforts of Me mber States to increase the number of 
healthy life years of the EU population......................................................................................38  
6. Policy options.............................................................................................................. ...........39 
6.1. Options considered........................................................................................................ .39 
6.2  Option 1.................................................................................................................. ........40 
6.3 Option 2................................................................................................................... .......42 
6.4 Option 3................................................................................................................... .......44 
6.5. Option 4.................................................................................................................. ........55 
6.6.  Comparison and assessment of the options....................................................................55 
7. Monitoring and evaluation ................................................................................................... ..57 
7.1. Multi-annual programming ............................................................................................57 7.2. The financial mechanisms..............................................................................................58 7.3.  Simplification........................................................................................................... ......58 
7.4. Indicators................................................................................................................ ........59 
7.5. Evaluations............................................................................................................... ......63 
ANNEX 1: DGs IN THE STEERING GROUP.............................................................................64 ANNEX 2 - Timetable ............................................................................................................ .......65 
 
 2ANNEX 3: Ex-post evaluation of the Pub lic Health Programme 2003-2007(conducted by 
COWI S/A) 66 Executive summary.............................................................................................................. ..........68 
1.1 Introduction ............................................................................................................... .....68 
1.2 Methods.................................................................................................................... ......68 
1.3 Main results and conclusions .........................................................................................69 1.4 Recommendations ..........................................................................................................72  
ANNEX 4 – KEY MESSAGES AND EXECUTIVE SUMMARY OF THE MID-TERM EVALUATION OF THE HEALTH PROGRAMME 2008 - 2013...............................................74 1. KEY MESSAGES ................................................................................................................ ......74 
1.1 Key messages of the evaluation ...........................................................................................74  
1.1.1  Conception .................................................................................................................74 
1.1.2  Design .........................................................................................................................75 
1.1.3  Management ...............................................................................................................75 
1.2. The five highest ra nking recommendations ........................................................................76 
2. EXECUTIVE SUMMARY ........................................................................................................77 
2.1 Background, objectives and approach..................................................................................77 2.2 Key conclusions ............................................................................................................ .......78 
2.3 Key recommendations........................................................................................................ ..80 
ANNEX 5 – Discussions and consultations with  health stakeholders and institutional 
interlocutors  - Summary....................................................................................................... .........83 
ANNEX 6 – LIST OF HEALTH LE GISLATION AND LEGISLATION ON 
PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES ..............................................85 ANNEX 7: CASE STUDIES .........................................................................................................9 0 
1.1. CASES STUDY N°3; ORPHANET: The EU porta l for rare diseases and orphan drugs
 100 
 
 
 
 3INTRODUCTION  
In its Communication ‘A Budget for Europe 2020’1 the European Commission proposed an 
allocation of € 396 million for the period 2014-2020 for an expenditure programme in the area of health. This initial budgetary pr ovision was to be followed up by a detailed legal proposal for a 
future Health Programme, to be a dopted by the College by the end of 2011. 
This report therefore has to be s een as a key milestone in this pr ocess. Its purpose is to describe 
the main challenges facing health in Europe to outline the framework for EU initiatives in this 
policy area, alongside the action taken by the Member States. It aims also to define the objectives 
and demonstrate the value of the proposed Hea lth Programme and, finall y, to assess different 
options for such a Programme, focusing on their expected impact. 
This document therefore consists of the following sections:  
• Section 1 describes the expectations for the future Programme, on the basis of previous 
evaluations, audits and consultations with other departments of the Commission and third 
parties (Member States a nd other stakeholders). 
• Section 2 describes the policy context in which the Programme will operate and the main 
challenges common to all Member States cr eating incentives for action at EU level. 
• Section 3 explains the obj ectives of the Programme. 
• Section 4 discusses the right of the Union to  act towards those objectives (subsidiarity, 
necessity and EU added value). 
• Section 5 underlines the links  of the proposed Programme with the Europe 2020 Strategy. 
• Section 6 presents the policy options considered. They are each assessed against the 
objectives of the Programme, based on their exp ected impact, and are then compared with 
each other in order to conclude whic h one is the most suitable choice. 
• Section 7 sums up the main factors and in dicators for monitoring and evaluating the 
Programme.  
Finally, seven annexes add further details: 
• Annex 1: List of particip ants in the Steering Group for drafting this report. 
• Annex 2: Timetable for drafting this report and further steps. 
• Annex 3: Key points and executive summar y, including recommendations from the final 
evaluation of the Public Health Programme for 2003-2007. 
• Annex 4: Key points and executive summary, including recommendations from the mid-term 
evaluation of the Health Programme for 2008-2013. 
• Annex 5: Summary of main points raised in th e consultation with stakeholders and Member 
States. 
                                                
 
1 ‘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. 
 
 4• Annex 6: List of all the legislation that Programme will support in its implementation, 
application, evaluation and review. 
• Annex 7: Seven case studies illustrating the inte rvention logic, EU added value, results and 
impact of action financed under the curre nt and previous Health Programmes. 
1.  P ROCEDURAL ISSUES AND CONSULTATIONS WITH THIRD PARTIES  
1.1.  Organisation and timing  
Organisation 
The Inter-Service Group (ISG) on Health Policy has served as the steering group for the mid-term 
evaluations of the current Health Stra tegy and Programme (till 2013)  and also for the Impact 
Assessment (IA) on the new Programme post-2013. The first meeting of the Impact Assessment Steering Group (IASG) took place on 15 April, the second on 17 J une and the third on 18 July 
2011 ( see Annex 1
 for the list of Commission Directorates-General invited ). 
Timetable  
See Annex 2 . 
Sources of data 
• The ex-post  evaluation of the Public Health Programme (PHP) for 2003-2007 and the mid-
term evaluation of the Health Programme (HP) for 2008-2013. 
• The Joint Report on Health Systems, Occasi onal Papers 74/December 2010, prepared by the 
European Commission and the Economic Po licy Committee/Working Group on Ageing 
(AWG). 
• The Court of Auditors special report No 2/2009 ‘The European Union’s Public Health 
Programme (2003-2007): An effectiv e way to improve health?’ 
• Other studies, in-depth surveys and impact assess ments on legislative initiatives in the area of 
health. 
1.2.  Expertise and consultations  
The new Health Programme (the ‘Programme’) should build on the results achieved by both the 
Public Health Programme (PHP ) for 2003-2007 and the current Health Programme (HP) for 
2008-2013. It should do so in line with the conclusions drawn and recommendations made in the different evaluations and audits performed on these programmes.  
1.2.1. Main results of the ex-post  evaluation of the Public Health Programme (2003-2007)
2 
and the mid-term evaluation of  the Health Programme (2008-2013)3  
Originally, the first Public Health Programme (2003-2007) gr ew out of a small number of 
isolated, empirically managed activ ities in response to calls fr om the Council a nd the European 
Parliament, such as action on HIV/AIDS, health  information, etc. Inevitably, the number of 
                                                 
2 See Executive summary under Annex 3. 
3 See Executive summary under Annex 4. 
 
 5priorities gradually increased, to meet the new expectations, until they reached a point well above 
what could be manageable and make a strong impact. Neverthele ss, the evaluation of the PHP 
recognised its strong potential contribution to pr eparing, developing and implementing EU public 
health policies even if it tried to cove r too broad spectrum of health priorities. 
The 2nd Health Programme (2008-2013) followed sim ilar design as the first one, facing similar 
difficulties ( this is discussed in details in section 2.2.1 .). The mid-term evaluation, however, 
concluded that even though the HP is relatively mi nor in terms of a magnitude, it has a significant 
impact on the work done by public health practitione rs across the EU. It achieves certain, albeit 
modest, global resonance that is important for its recognition. The HP is instrumental in creating 
and maintaining a strong professional public hea lth community at European level that finds it 
natural to exchange knowledge and experience. As a matter of fact, the presently modest yet 
laudable efforts on data collecti on and exchanges between Member States would not have taken 
place without the support of the Programmes. 
Second, the HP made it possible to develop many ac tivities, for example on health determinants 
and comparable health data, in new Member States, where the economic situation and budget 
restrictions would not have allowe d them to be made a priority. 
Third, the current Programme has pr omoted important issues at EU  level and on national political 
agendas, such as rare diseas es and cancer-screening guidelines. It has also influenced 
policymaking and implementation at national level. In  this context, dissemina tion of the results of 
the PHP and HP is seen as another field where there is room for improvement and is directly 
linked to the underlying logic. The outcomes of the financed  actions targeting health 
policymaking at EU, national or regional levels are still not su fficiently known, so not always 
recognised and used by stakeholders and policymaker s. However, this is essential to ensure the 
sustainability of the results and to help monitor the impact of actions under the new Programme.  
At management level, there has been a signifi cant improvement in delivery of the Programme, 
mainly due to outsourcing of the management  to the Executive Agency for Health and 
Consumers. The procedure for selecting actions to  be funded has been tightened up to make sure 
that the best applicants are selected. The new financial mechanisms introduced in the 2nd 
Programme have generally been posit ively received and widely used.  
1.2.2. Main conclusions of the evaluations a nd indications for a new Health Programme 
First:  The post-2013 Health Programme should be much more focused and concentrate financial 
support on a smaller number of activities  in key priority areas, br inging the biggest EU added 
value.  It was underlined by the Court of Auditors in th e report ‘The European Union’s Public 
Health Programme (2003-2007): an e ffective way to improve health?’4 
Second:  The post-2013 Programme should be able to serve and involve all EU Member States  
better , especially those with rela tively low Gross National In come (GNI), where numerous 
cultural, procedural and financ ial barriers reduce the opportuni ties to participate. Emphasis 
should be placed on areas where Member States cannot act in isolati on in a cost-effective  
manner,  where there are clear cross-border or internal market issues or where there are significant 
advantages and efficiency gains fr om collaboration at EU level.  
Third:  The evaluators recommended adopting more tangible and specific, measurable, attainable, 
relevant and time-bound (SMART) objectives for the Programme,  set in a better defined strategic 
framework with long-term targets. Limiting the nu mber of activities to the ones that concern the 
                                                 
4 http://eca.europa.eu/portal/pls /portal/docs/1/2838313.PDF. 
 
 6most Member States and where th ere is a real value in taking act ion at EU level could increase 
efficiency gains and maximise the impacts of the Programme. Action and results need to be built into a regular reporting system
 and shared more effectively within the Commission and with 
stakeholders and national policymakers. 
1.2.3. Consultations with third parties 
In line with the main recommendation of external evaluations, namely to reduce the number of 
priority areas of the Programme, the consultation wa s targeted at Member States’ representatives, 
for instance national focal points, the Senior  Working-Level Group and the informal Health 
Council. Additional expert advice was provided th rough the EU Health Policy Forum, by health 
professionals and patients associ ations. Other stakeholders, especi ally the beneficiaries, have 
expressed their views in recent evaluations. 
Representatives of Member States and NGOs partic ipating in the various consultations strongly 
supported the continuation of the Health Programme. While unani mously agreeing with this 
need, some Member States concurred with the vi ew that it should be more focused, cost-efficient 
and supporting actions with proven EU added value.  Others however were of the opinion that it 
should continue to support the existing objectiv es and a wide range of actions. 
When expressing their views on the EU Health Strategy (in the context of its mid-term 
evaluation) the vast majority of Member States consider it as a framew ork or driver of best 
practice exchange at EU level and for cooperation with other Member States. In this context 
many mentioned the possibilities provided by the Health Programme, in particular the joint 
actions , as very important for thei r national health policies . 
National focal points, designated by Member Stat es’ authorities, argued that the Programme 
should continue to support national policies by: 
• providing best practices to follow at national level; 
• sharing and exchanging practical ex perience, expertis e and knowledge; 
• giving support on health issues on the national political agendas. 
The areas suggested by Member States to be tackled by the post-2013 Health Programme were: 
• health systems sustainability and reform; 
• health impact of demographic change (healthy ageing and dementia); 
• health in all policies; 
• cancer; 
• major non-communicable diseases and chronic diseases; 
• rare diseases; 
• communicable diseases; 
• prevention and action on major health determinants (alcohol, tobacco, etc.); 
• mental health; 
• health promotion, including promotion of  a healthy life, nutrition and obesity; 
• e-Health; 
 
 7• other topics mentioned less fr equently: health technology asse ssment, sexual health policy, 
health indicators, etc. 
Furthermore, Member States and stakeholders alik e stressed the need to engage all EU countries 
more actively in the Programme. They also emphasised that the Programme should be more closely linked to the Treaty, to the  EU 2020 agenda and to the existing legislation.  
Stakeholders gathered in the EU Health  Policy Forum reasserted that it is fundamental to have a 
new Programme,  especially for patients , and to support health lite racy and the fight against 
health inequalities. According to them the curr ent financial mechanisms for EU public health 
should be maintained. 
The Forum stressed that strong emphasis should be put on health determinants and a patient 
centred focus. They also recommended that th e Programme addresses the role of social 
determinants, thus making an impact  on reducing health  inequalities.  
A human rights approach  to support EU public health was a dvised - one that is equipped with 
adequate resources and that re flects non discrimination in health care provision. Several members 
of the Forum expressed worries for the future of the Programme , as they fear that less support 
might be provided to the work being done towards improved publ ic health and its outcomes. 
Prioritisation of projects  within the Programme should be discussed with the stakeholders. 
Moreover the Programme should have l onger as well as short terms goals.  
In addition coordination between Europe an and national programmes  could be a guarantee 
for greater involvement of Memb er States and a solution to avoid fragmentation of efforts 
deployed in multiple levels (nat ional, local, European). The difficulties to access  the Programme 
were raised by some members of the Forum, even if it was underst ood that there are strict rules 
for the use of EU funds. In the area s of funding, they argued, there is a need to balance between 
the joint actions and core funding for project grants . 
Further contributions were received from health st akeholders and have been  taken into account in 
this document and, beyond that, in drafting of the Programme. Overall 20 organisations have 
provided written contributions out of the 52 member  organisations participa ting in the EU Health 
Policy Forum.  
The details of consultations  are provided in Annex 5
. 
 
1.3 Impact Assesment Board's comments:  
The recommendations made by the Impact Assessment Board have been taken into account in the 
following way: a paragraph has been added to pres ent the policy context and a table explains the 
link between identified challenges, MFF announ cements, policy objectives and specific 
objectives; evaluation recommenda tions have been added to the problem definition, more 
explanation and evidence have been added abou t the necessity of the programme and the EU 
added value. 
Regarding policy options, the baseline scenario has been strengthened, sub-options have been 
added to option 3the focus for each of the sub-op tions has been clarified and an overview of the 
planned budget allocations for the different areas of intervention has been provided. The 
assessment of the impact has been  developed and examples have b een added also from previous 
programme experience. 
 
 8Regarding the indicators, we ha ve explained that, the programme  being a supporting programme 
for policies, it's main impact can only be measured  at the level of Member States in their uptake 
of the guidelines, best practices, advices that will be developed under each specific objectives. 
Thus, output indicators can only measure the production of these best practices, tools, 
mechanisms, guidelines, that have been develope d. And impact indicators can only be about the 
uptake of these best practices, mechanisms, guide lines by the end users. Thus, the success of the 
Programme can only be defined in terms of the rate of implementation, participation by Member 
States and take-up of the outcome in the differe nt Member States and stakeholder groups, on top 
of the actual results achieved comp ared with predefined levels. 
Finally, evaluations arrangements have been im proved and more details have been provided on 
stakeholders views. 
 
2.  PROBLEM DEFINITION  
In order to demonstrate the valu e of the proposed Programme, this  section is structured around 
three key issues: 
• the policy context; 
• the key challenges for public health  in Europe in the years ahead; 
• the specific context for EU action in the ar ea of health, with its inherent limitations. 
2.1.  Policy context  
The points already included in the Commissi on’s Communication of 29 June 2011 ‘A Budget for 
Europe 2020’ are to be taken into account as the pre-defined overarching framework for the 
Programme. As stated in this Communication, " 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 cros s-border health threats , 
• to increase the sustainability of health services,  
• to improve the health of the population, wh ilst 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 ". 
 
 9Four particularly important factors for the desi gn of the Programme are the general principles 
underpinning the overall budgetary proposal outlined by the Commission in the 2010 budget 
review: 
• focus on delivering key policy priorities; 
• focus on EU added value; 
• focus on impact and results; 
• deliver mutual benefits across the European Union. 
The definition of the aim, objectives and the sc ope of the Programme, proposed below in Section 
3, takes full account of these principles, in bot h the design and the implementation phases. In 
doing so, the proposed Programme is in line with  the Commission’s general statement on the 
budgetary proposal, i.e. that the EU budget expresse s ‘policy in numbers’, in that the funding 
must go hand in hand with the ex isting regulatory environment and the policy priorities in the 
relevant areas. 
As a consequence, in order to  ensure that its out put and impact push forward the key policy 
priorities of the EU, in line with the Europe 2020 Strategy, th e Programme will concentrate on a 
limited number of high-profile pr iorities and activities where it can build up a critical mass, inter 
alia by exerting a leverage effect and complementing Member States’ action. 
2.2.  Defining the problem and its causes and effects  
 
In the area of health the challe nges for Member States are serious  while the expectations of the 
patients and stakeholders are high. Member States are under pressure  to strike th e right balance 
between providing universal access to high quali ty health services and respecting budgetary 
constraints. 
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 Tr eaty, is to complement and support these national 
policies and encourage cooperati on between Member States.  
The challenge is to build an EU Health Programme  that serves the best the interests of Member 
States and other stakeholders with in 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 Euro pean, national and local level.  
The Programme should provide possi bilities to build and strengthe n cooperation mechanisms and 
coordination processes between Memb er States with a view to id entifying common tools and best 
practices that create syne rgies. It should bring the biggest EU added valu e and lead to economies 
of scale, thus supporting reform s under challenging circumstances.  
2.2.1. The past experience and a new process leading to a better design of the Programme  
According to the ex-post evaluation, the Public Health Programme lacked explicit intervention 
logic on the basis of clearly de fined objectives linked to acti ons and corresponding performance 
indicators. As a result, the PHP had no strategi c focus. For example, the programme’s 'action 
areas' established in the annual work plans (AWP s) outnumbered the projects funded to address 
them and there was no sufficient competition between the proposed projects. The project 
 
 10proposers were invited to apply for funding unde r very general headings. The multiplicity and 
diversity of project topics and target groups resulted in the dilution of inputs and led to 
fragmented results. 
The 2nd Health Programme has similar objectives as the PHP. They are far reaching and 
encompass most areas of public health in Euro pe. As a consequence the implementation of the 
Programme faces similar difficulties caused by the lack  of clear intervention logic. It is hard to 
demonstrate how actions lead to the achieveme nt of HP's goals and how progress can be 
effectively measured. Additionally there is still not enough of prioritisa tion of actions in the 
Annual Work Plans, and there are problems to disseminate satisfactory results of the funded 
actions and to measure their impacts. Following the mid-term evaluations' recommendations some corrective measures are now being implemented but they cannot heal the root causes of the problems. 
Recommendations
5 stemming from the report of the Cour t of Auditors in 2008 and the external 
evaluations of the previous a nd current programmes demonstrated  that the problem lies in the 
design of the Programme itself. In all audits and evaluations si milar recommendations were made 
(see comparative table with the highest ra nked recommendations in annex 3bis) and  stressed the 
need:  
• to improve the concept and the design of the future Programme with an explicit 
intervention logic; 
• to focus the Programme on SMART objectives , and reduce the number of priorities; 
• To better take into consideration the real n eeds and what is achievable within the limited 
budget, and 
• To support actions that will create proven EU added value. 
The definition of well targeted Programme objectives  starts with a horizon scanning of the most 
relevant health challenges that Member States are facing.. This is  crucial in order to align the 
Programme to real needs and ensure that the ex pected outcomes will be used to improve national 
health policies. The Programme should support ac tions with proven EU added value and suggest 
solutions that cannot be found by each MS indivi dually and so the leading role of EU makes 
sense. 
2.2.2. Major challenges for the health in the EU 
"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"   
(Commission’s Communication ‘A  Budget for Europe 2020’)  
Health is not just a value in itself - it is also  a strong economic driver for growth. Health care 
expenditure accounts for nearly 10  % of the EU’s gross domestic product6 and is one of the 
                                                 
5 The main recommendations of Court of Auditors report, ex-post evaluation of PHP 2003-2008 and mid-term 
evaluation of HP 2008-2013 are presented  in annex 4 pages 72-74.  
6 Source: Source EC/EPC Joint Report on Health Systems, p.46. The average is 9.6 %. 
(http://ec.europa.eu/economy_fin ance/publications/occasional_pa per/2010/pdf/oc p74_en.pdf)" 
 
 11largest economic sectors in the EU. Moreover it  is driven by innovation and a highly qualified 
workforce. The health care sector employs one in 10 workers in the EU7 and among the most 
qualified, since it has a higher than  average proportion of workers with tertiary-level education.8 
This weight gives the health care sector an impor tant role to play in the economy in general and 
in contributing to the Europe 20209 Strategy. There is a strong ev idence of the link between 
health and economic performance:10 a population in good health is a sine qua non  for attaining 
smart, sustainable a nd inclusive growth. 
Good health is one of the most important f actors for increasing indi vidual productivity and 
consumer empowerment. An increase in the numb er of productive years as a result of better 
health has an immediate positive impact on collective productivity and competitiveness. Finally, investing in health can boost i nnovation, as health-re lated research and development has the 
potential to reach 0.3% of GDP. It  creates new skills and jobs and addresses the challenges of an 
ageing society. The conclusions of the last Council meeting of Health Ministers made a point on 
this aspect of investment.
11 
Over the next 20 years, the number of Europeans ag ed over 65 is expected to rise by 45 %, from 
85 million in 2008 to 123 million in 203012. While the steady increase in life expectancy at birth 
is a major achievement of the recent past, living older does not necessarily mean doing so in good 
health. Issues arising in this context are rela ted not only to protecting, promoting and improving 
the health status of the elderly, but also to fina ncing the rising healthcar e costs and to improving 
the healthcare offered, in response to hi gher expectations, and also access to it. 
In order to ensure that the potential improvement s reach citizens effectively, both as individuals 
and as members of an EU-wide community, major problems and challenges need to be overcome. 
These problems are not necessarily new, but they are most often analysed separately, within the 
specific national or thematic context. It is, howeve r, clear that they are strongly linked, that there 
is the European wide context that requires EU-wide collab oration and common responses, with 
due respect to the principle of subsidiarity and the ultimate responsibility of Member States. 
A well designed and realis tic Health Programme can contribu te to and complement Member 
States' actions to increase the number of years Europeans live in good he alth through finding and 
applying innovative solutions for th e improvement of quality and sust ainability of health systems, 
putting the emphasis on human capital and exchange of best practices. 
2.2.3. Financial sustainability of health systems 
For several years now, Member States have been facing budget constraints with implications for 
the sustainability of their he alth budgets, which account for 15  % of public expenditure.13 They 
                                                 
7 Source: Eurostat ‘Employment in human health and social work activity’. 2008: 9.6 %; 2009: 10 %; 2010: 10.3 %. 
7 43 % compared with 25.5  % for the average for the other economic sector s. Source: Factsheet of Eurofound, using 
data from the European Working Conditions Survey: http://www.eurofound.europa.eu/pubdocs/2008/1423/en/1/EF081423EN.pdf
 (see page 2). 
9 Communication from the Commission: ‘Europe 2020 — A strategy for smart, sustainable and inclusive growth’ 
COM(2010) 2020 final. 
10 Several quantitative economic studies using methods such  as multivariate analysis, along with more classical 
observational cohort studies, have produced strong evidence of the links between health and growth (BMJ 333: 1017, 9.11.2009, M.Suhrke et al.). 
11 http://eur-lex.europa.eu/LexUr iServ/LexUriServ.do?uri=OJ:C :2011:202:0010:0012:EN:PDF. 
12."Ageing report 2009" http://ec.europa.eu/economy_finance/publications/publication14992_en.pdf. 
13 Source: Eurostat ‘General expenditure by functio n — health compared to total’. 2009: 14.63 %. 
 
 12are challenged by an ageing popula tion, rising expectations for high-quality services and the 
emergence of new technologies. These constrai nts have increased with the curbs on public 
spending in the wake of the debt crisis. 
Evidence14 suggests that effective health system re forms show potential for containing ‘excess 
cost growth’, i.e. keeping health spending in line with GDP growth. 
In this area, the EU intends to  support Member Stat es in achieving their ‘budgetary’ targets, 
while also ensuring that the impact of such reforms is not only assessed from a short-term 
budgetary perspective, but also seen in a broa der social context to secure health system 
sustainability in the long term too. 
Broadly speaking, the collaboration  envisaged should cover a wide  spectrum of issues related 
both to the supply side for health services a nd to the related costs. Planning, costing and 
reimbursement of healthcare servi ces is one key area. In this context, the role of health 
technology assessment as a tool to be used acro ss the EU and for achieving economies of scale by 
working closely with other Member States is a pr iority. A second key area is close collaboration 
on addressing the scarcity of res ources, both human and financial. 
Finally, building up their knowledge base about what works and what does not in health system 
organisation and reforms is another area where Memb er States can learn from sharing experience 
and practice, both positive and negative. 
2.2.4. Health workforce shortages 
Demographic developments in the EU will re sult in healthcare systems competing for a 
dwindling working-age population, with fewer and fewer potential healthcare workers. In 
parallel, with an ageing population and the availability of informal  care in the family environment 
declining as a result of changi ng family structures, the demand for formal, professional care is 
increasing. Healthcare has also become more sp ecialised and requires mo re intense work and 
longer training. These trends are currently challenging the traditi onal health workforce planning 
tools and policies of Member States. 
Estimates show that, by 2020, one million health workers will be missing in the EU and 15  % of 
the care needed will not be covered.15 All Member States will face shortages of health workers 
(doctors, nurses, others professionals) and coul d therefore benefit from  cooperating with each 
other. Health workforce shortages can increase re gional health disparities and put at risk access to 
high-quality healthcare in some Member States . These structural shortages in the health 
workforce in Europe are accompanied by rural/ur ban disparities and the escalating brain and 
skills drain from poorer to richer and from  new to old Member States of the EU. 
Recent cases brought before the Eur opean Court of Justice shows th at some Member States have 
resorted to measures that are in breach of th e principle of free movement of persons, e.g. by 
limiting the number of foreign students in their me dical faculties or halti ng emigration of freshly 
graduated health professionals. Efforts should be made to support Member States in addressing 
these challenges in collaboration a nd not in isolation, in particul ar their efforts on educating, 
recruiting and, especially, reta ining young practitioners in a ll health professions, while 
reinvesting in the mature workforce.  
2.2.5. Improvements necessary in patient safety  
                                                 
14 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 estima ted at an average of about 1 % for the OECD). 
15 Communication from the Commission ‘An agenda for new skills and jobs’, COM(2010) 682 final. 
 
 13On average in western European countries, about 10  % of patients suffer an adverse event,16 
which has consequences for them and the health care system. Data show that the confidence of 
patients in healthcare is not high. More than half of  EU citizens are afraid of being harmed in the 
healthcare process.17 
Estimates suggest that infections with bacteria  resistant to medicinal products cause about 25   000 
deaths and at least 1.5 billion euros in ex tra healthcare costs every year in the EU.18 In addition, 
healthcare-associated infections (HCAI) hit 4.1 million patients and result in 37  000 deaths every 
year in the EU.19 Although published scientific studies and re views indicate that a reduction of 20 
to 30  % in healthcare-associated infections is highly cost-effective, evidence suggests that 
Member States are at different levels in developing and implementing effective strategies against 
HCAI. 
2.2.6. Lack of sustained progress on control and prevention of chronic conditions 
According to the latest Global Status Report of the World Health Or ganisation (WHO) on non-
communicable diseases20 (NCDs), the situation in the EU is worrying. In 2009, over 4 million 
deaths in Member States were attributable to such diseases, with nearly 50  % being caused by 
cardiovascular diseases and diabetes, around 26% by cancer and 8% by chronic respiratory 
diseases. These numbers demonstrate that there is  still much room for improvement in control 
and prevention of chronic c onditions. This could, in turn, yield big gains in overall quality of life 
and save very large amounts of  public and household expenditure. 
For instance, the reduction of cancer mortality ra tes has been modest. Despite a decrease in the 
overall mortality rates,21 the absolute number of cancers is unlikely to decline and gaps persist 
between old and new Member Stat es. More worryingly, recent st udies in transitional countries 
show that the downward trend in mortality due to  cardiovascular diseases can, unfortunately, be 
reversed. 
It is therefore crucial that Member States not only collabor ate to develop and disseminate 
validated tools and approaches for prevention, bu t also work together in supporting large-scale 
and EU-wide implementation of the policies and practices that work. 
2.2.7. Loss of best productive years in much of the population because of the slow increase 
in healthy life years (HLY) 
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 th e EU in 2008. By contrast, the average number 
                                                 
16 Technical report ‘Improving Patient Safety in the EU ’ prepared for the European Commission, published in 2008 
by the RAND Cooperation. 
17 Special Eurobarometer 327. ‘Patient safety and quality of healthcare’. April 2010: 
http://ec.europa.eu/public_opinion/archives/ebs/ebs_327_en.pdf. 
18 ECDC/EMA joint study ‘The bacterial ch allenge: time to react’, September 2009: 
http://www.ema.europa.eu/docs/en_GB/docu ment_library/Report/2009/11/WC500008770.pdf . 
19 Impact Assessment on a proposal for a Council Recommenda tion on patient safety and quality of health services, 
including the prevention and control of healthcare-associated infections. SEC(2008) 3004, Annex 3, pp. 49-50: 
http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=SEC:2008: 3004:FIN:EN:PDF. 
20 http://whqlibdoc.who.in/publications/2011/9789240686458_eng.pdf . 
21 Malevezzi et al., ‘Advances in Oncology’, OUP 2011 do i:10.1093, European cancer mortality predictions for 
2011. 
 
 14of HLY has been progressing at a much slower  pace and was only 60.9 years for men and 62 
years for women. Moreover this varies wi dely from one Member State to another. 
In addition, a significant level of premature mortality or prem ature invalidity can be found in 
many places, with a very significant impact on the workforce. By way of illustration, in 2007 the 
number of deaths among people of wo rking age totalled approximately 900  000, equivalent to 
about 19  % of all deaths that year.22 
Also people with health probl ems show very low participation in the labour force23 And it has not 
increased over the last decade. Consequently, the level of unemployment of such people is twice 
as high as that of people without a disabilit y. Development of the human capital crucial for a 
knowledge-based economy is therefore greatly impaired. 
The financial impact is significant: it is estimat ed that, on average, OECD countries spend 1.2  % 
of GDP on disability  benefits and this figure rises to 2  % when including sickness benefits.24 
According to the latest figures, EU governments have been spending twi ce as much on illness 
and disability benefits as on unemployment benefits. 
Solutions to these problems depend not so much on gaining better insight s into the most cost-
effective ways to reduce premat ure mortality, since the factors most to blame for modest HLY 
are known,25 but more on understanding ways to impleme nt large-scale measures covering entire 
populations. This will therefore be  the focus of activities in this area to be covered by the 
Programme, as Member States stand to gain from EU-wide collaboration and exchanges on 
practices which aim at redr essing the loss of the best years of productive life. 
2.2.8. Increasing inequalities in health throughout Europe 
Health inequalities have become a central conc ern of policymakers in many parts of the world 
and the EU offers a striking image in this respec t. Population health vari es enormously between 
different parts of the EU and between advantag ed and disadvantaged gr oups. Life expectancy 
amongst males  varied by 11.9 years between Me mber States in 2009 and 7.6 years for women. 
Health inequalities within Member States are also very large. The Eurostat has estimated that the 
difference in life expectancy between men with higher and lower levels of education varied 
between Member States from around 4 years up to n early 20 years. Life expectancy for the Roma 
population is up to 10 years shorte r than the general population. 
The main causes of these inequalities in health ar e systematic difference in determinants of health 
experienced by different populations, including so cial, economic, environment and behavioural 
factors. The persistence of such inequalities is by no means a fatality. A number of Member 
States have built up experience of  successfully reducing inequalities at a rapid pace, for instance 
in Germany following reunification,26 while there is also value to be gained from working 
together on unsuccessful experience and learning from each others’ mistakes.27 
                                                 
22 Oortwijn, W., Nelissen, E., Adamini, S., Van den Heuvel, S ., Geukens, G., Burdof, L., Social determinants state of 
the art reviews — Health of People of Working Age — Full report (2011), European Commission Directorate-
General for Health and Consumers. Luxembourg. ISBN 978-92-79-18526-7. Point 3.5.1, page 81. 
23 Sickness, disability and work. Keeping on track in the economic downturn. Background paper. High-Level Forum: 
Stockholm (14-15 May 2009), pp. 11 to 13, Organisation for Economic Cooperation and Development (OECD) 2009: http://www.oecd.org/dataoecd/42/15/42699911.pdf
. 
24 Idem, footnote 12. 
25 See The Lancet on the forthcoming UN conference on non-communicable diseases. 
26 Report on Health in Germany 20 years after re unification, Robert Koch Institut, Berlin, 2010. 
27 Mackenbach article in The Lancet on UK experience 
 
 15Although, clearly, part of the link be tween the causes and effects of health inequalities could lie 
outside the health policy area, pr imarily in social inequalities,  there is sufficient ground for 
fostering the collaboration between Member States to address, jointly, differences in access to 
healthcare, especially in the context of appli cation of the Cross-border Healthcare Directive. 
2.2.9. Global and cross-border threats 
After the industrialised world was close to eradica ting the most serious infectious diseases in the 
late 1970s, the rapid social and economic cha nges triggered by globalisation have brought new 
factors that are driving th e return of old pathogens and the rise of new ones. 
The Treaty gives the European Union specific re sponsibility for averting cross-border health 
threats, i.e. events caused by communicable diseas es or by biological, chemical, or environmental 
agents or of unknown origin. 
The great value of improving crisis  preparedness and management to safeguard against the very 
severe consequences of such th reats to public health has been amply demonstrated over the last 
decade. Opinion polls also show the value that most stakeholders see in the past and present 
action by the Commission in this area. Cooperation at EU level not only allows multi-sectoral 
aspects to be made an integral pa rt of crisis preparedness and mana gement. It is also structured in 
a way that takes the interests and needs of smaller Member States into account while, at the same 
time, keeping the internal market func tioning and the borders in the EU open. 
3.  T HE POLICY OBJECTIVES  
The challenges identified in sect ion 2 are not at all new. The need to face them together by all 
Member States, with the modest support the EU  Health Programme can offer, has become 
however even more urgent in face of the current  financial crisis. The Programme can offer the 
biggest EU added value by focusing its interventi on on four key policy objectives, covering five 
specific objectives for actions de scribed below in this section. 
 
"The new Health for Growth Programme will be oriented towards actions with clear 
EU added-value, in line with the Eur ope 2020 objectives and new legal obligations . 
The principal aim is:  
- to work with Member states to protect ci tizens from cross-border health threats,  
- to increase the sustainability of health services, 
- to improve the health of the population, whilst encouraging innovation in health". 
(Commission’s Communication ‘A  Budget for Europe 2020’)  
 
3.1. Policy objective 1: Contributing to i nnovativeand sustainable health systems  
By supporting Member States' efforts to improve th e efficiency and financ ial sustainability of 
health care, the EU Health Programme aims at enc ouraging a shift of significant resources in this 
sector on the most innovative and va luable products and services wh ich at the same time offer the 
best market potential and cost sa vings 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 wa y if countries are to ensure unive rsal access and eq uity in health, 
health financing and use of the system. As an example, European cooperation on health 
 
 16technology assessments  will not only reduce duplication and pool expertise but can unlock the 
potential for sustainabl e innovation in health products and services. 
It is of utmost importance to develop common t ools and mechanisms at EU level to help national 
health systems deliver more care with fewer res ources. Innovative solutions are needed to tackle 
workforce shortages and to maximise the effi ciency of health systems through the use of 
innovative products, services and tools. 
The EU 2020 strategy identifies innovation as a key to creating smart gr owth. There is a huge 
"smart growth" potential in health which can lead  to increased efficiency and the creation of new 
health interventions and produc ts 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 efficien tly what is already available and creating the 
right conditions for future i nnovation. 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. 
To achieve this, the Programme will: 
Specific objective 1: develop common tools and mechanisms at EU level to address shortages 
of resources, both human and financial, and faci litate up-take of innovation in healthcare in 
order to contribute to innovative and sustainable health systems. 
The cost-effective use of medical technologies,  including the upcomi ng therapies based on 
genomic science, an adequate supply of health  professionals, expertise necessary to improve 
decision-making, as well as support for the Innova tive 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. 
3.1.1. Health technology assessment  
Health technology assessm ent (HTA) can provide decision-m akers with an evidence-based, 
transparent basis for decisions on taking up and phasing out health technologies, thereby making 
the best use of health budgets an d providing the best tr eatment to patients. In the increasingly 
difficult context of constrained fi nancial resources, the impact of  HTA could be increased if it 
were commonly used throughout the EU (see case study in Annex 7). 
By 2014, an EU-wide voluntary network on HT A will be established, with a common 
methodological basis and tools for interaction. In  addition, by the same date a number of pilot 
schemes will have been launched to test the tools already developed and explore specific 
cooperation models for joint assessments of  new medicinal products  and other health 
technologies. The outcomes of these pilot schemes, to be completed in 2015, will provide useful insights into how effective EU cooperation on health technology assessment could be organised 
towards 2020 onwards. The Programme will conti nue to lend support to EU cooperation on HTA 
in order to address the challenges identified by: 
• supporting further development of common methods  for evaluating new health technologies, 
in order to avoid duplication of  work, to help identify cost-e ffective health intervention at 
national/regional levels and thus obtain economies of scale; 
 
 17• supporting capacity-building measures on rational use of HTA for health administrators at 
national level. This is particularly relevant for those Member States with limited experience 
of use of HTA so far; 
• establishing common guide lines for submissions by the industry on pricing and 
reimbursement of new medicines and medical de vices, so that the industry can improve the 
quality of data from its clinical tr ials submitted to the assessment bodies; 
• establishing effective ways of  liaising with the industry in order to speed up assessments 
conducted after market authorisation is given. 
3.1.2. Health innovation and e-Health 
Mobility of patients across Europe also requires  interoperable e-Health solutions for emergency 
care and continuity of car e. After substantial support for larg e-scale projects to develop such 
interoperable tools, there is now a clear need fo r Member States and stakeholders to take some 
tangible decisions in order to achieve effective in teroperability. Otherwise,  the risk of making 
massive e-Health investments suitable for lo cal solutions only will increase and will prevent 
patients from having access to cross-border care. In  addition, the Directiv e provides for drawing 
up guidelines on use of e-Health solutions as a wa y to collect epidemiological data across borders 
in order to obtain better feedback on the effectiveness of treatments. 
This would be done by: 
• adopting guidelines after consulta tion of the e-Health network; 
• establishing a non-exhaustive list of  data that are to be included in patients’ records; 
• developing effective methods for allowing us e of medical information for public health 
purposes and research, incl uding patient registers. 
Such solutions will enable policymakers and health professionals to make better informed 
decisions on the appropriate treatment. This would also serve HTA, clinical trials and quality of care. In addition, e-Health can be considered a domain for technical so lutions to strengthen 
healthcare, for example by increasing efficiency  and promoting safety and quality. A common 
approach in the EU is needed for topics which ca ll for interoperability of systems and data and to 
optimise the development of technical solutions. 
3.1.3. Health workforce 
To address the predicted shortage of 1 million hea lth professionals in 2020, a series of measures 
are needed at both EU and Member State levels. The aims would be to develop effective health 
workforce planning, in terms of numbers and sk ills, to monitor mobility  (within the EU) and 
migration of health professionals, to develop effi cient recruitment and retention strategies and to 
build capacity. This action could include: 
• Continuing the work on the EU platform for Member States, to be initiated in 2012, to 
collaborate on forecasting health workforce ne eds, workforce planning methods and mobility 
trends. The platform would tell policymakers that valid and reliable information is available. 
It would also make it easier to transfer  successful solutions between countries. 
• Supporting implementation by Member States of the WHO Code of Practice on the 
international recruitment of health personnel in  the EU-specific contex t of free mobility of 
persons and services. The recently adopted Code aims at ensuring that international recruitment of health professionals does not  weaken already fragile health systems. 
 
 18• Promoting successful strategies for professional r ecruitment to the health  sector and retention 
of health workers in their jobs. 
• Encouraging cross-border educa tion and training by implemen ting exchange programmes for 
health professionals as part of their curricula; bilateral agreements on sharing training 
capacity or use of ICT solutions for distance-learning to increase the flexibility of the health 
workforce on the labour market. 
3.1.4. Better decision making on Health systems 
There is a political momentum for health system reform in Member States. Furthermore, there is 
a demonstrated need, in the light of the EU 2020 headline targets, to conduct a broad-spectrum 
assessment of all wider societal effects of health sy stem reforms. This is crucial in order to secure 
the long-term sustainability of Member Stat es’ health systems. To  avoid duplication of 
assessments at Member State level and to spee d up execution and increase the success rate of 
health system reforms, the Commission should be able to reply to requests from Member States 
for advice on how to organise and manage their health systems better and effectively foster 
sharing of best practice between Member States. 
A mechanism for pooling existing expertise at EU  level will be initia ted in 2012. The planned 
advice from the Commission will take the form of  technical evaluation of the consequences of 
policy action or of analysis of the expected outcomes of different and possibly conflicting 
policies, in order to provide Member  States with relevant informati on to take into account in their 
decisions. Provision of such advice will be all th e more necessary in the current context and over 
the years ahead and should ther efore be continued after 2013. 
3.1.5. European Innovation Partnership on Active and Healthy Ageing 
Announced in October 2010 as part of the Comm ission's "Innovation Union" strategy, the pilot 
European Innovation Partnership on Active and Healthy Ageing  represents a new, stakeholder-
driven approach to research and innovation. Th e ambition is to connect diverse actors and 
programmes in order to improve the conditions fo r innovation and bridge gaps between research 
and market, whilst ultimately benefit the final user s – the older people, care providers and health 
professionals and other carers. 
The Partnership offers a coordi nated framework for existing in struments and tools across the 
entire innovation chain in health and ageing, thus  aiming to build synergies and align these tools 
to optimise their use and efficiency. 
The Partnership focuses on three broader themes : 
• Innovation in awareness, prevention & early diagnosis  i.e., exploring actions on: health 
literacy, adherence and compliance, older people's functionality, early diagnosis & 
screening, coordination of research, lifestyle manage ment and nutrition, home 
monitoring. 
• Innovation in cure and care  i.e. identifying actions on:  continuum of care/integrated care 
inc. e-health, HTA and evidence  (cost-effectiveness and efficiency), innovative ways for 
management of multiple chronic conditions, cohesion funds and community care, training 
of care professionals. 
• Innovation in environment for active and independent living  i.e. focusing on actions 
related to: social inclusi on, working conditions for olde r people, older people's 
participation in the labour ma rket, independent living in an  age-friendly environment. 
 
 19The Health Programme may provide support to  specific actions under the Partnership.  
3.2. Policy objective 2: Increasing access to be tter and safer healthcare for EU citizens  
Improving access to healthcare to all citizens regardless of inco me, 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 heal thcare regardless of th eir 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 po or health status often has a substantial impact on 
accessibility to effective health care and the possi bilities of individual ci tizens 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 inequalitie s by addressing various health 
factors that give rise to and increase inequa lities, as well as complement action under other 
programmes specifically addressing social a nd regional differences within the EU.  
To improve access to healthcare, in particular fo r 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.  
To achieve this, the Programme will: 
Specific objective 2:  increase access to medical expert ise (European reference networks) and 
information for specific areas and beyond national borders and develop shared solutions 
and guidelines to improve heal thcare quality and patient safety in order to increase access 
to better and safer healthcare for EU citizens 
Scarce knowledge can be shared and resources comb ined as efficiently as possible across the EU, 
as can be seen, for instance, in the case of rare diseases.28 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 sp ecific disease or group of diseases. 
Such networks would add to the already subs tantial expertise and capacity for specific 
complex/high-tech diagnostic or treatment services of the cen tres participating, offering 
significant added value in the form of improved quality and cost-effectiv eness 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 empo wering 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 polic y objective would incl ude setting up accred itation and support of 
European reference networks, strengthening colla boration on patient safety and quality of care 
and improve the prudent use of antimic robial agents in human medicine. 
3.2.1. Setting up accreditation and support  of European Reference Networks 
                                                
 
28 See Annex 7 for case studies on European reference networks for rare diseases and ORPHANET. 
 
 20European reference networks (ERNs), to be se t up as provided for by the Cross-border Healthcare 
Directive29, will provide the general context by setting the criteria for designating centres of 
reference and for establishing, managing an d evaluating the ERNs. Once the period for 
transposition of the Dir ective ends, in October 2013, the operat ions and logistics related to the 
actual launch of the ERNs will start, in particul ar with the development of methods to identify 
and designate the centres and manage the netw orks on a permanent basis. This would imply: 
• launching the process for identifying and designa ting centres of reference which meet the 
criteria to be set out in the delegated act; 
• launching, managing and evaluating the European reference networks system, as provided for 
in the legal acts implementing the Directive; 
• designing and setting up a permanent mechan ism for running the network satisfactorily 
(means, structure and human and mate rial resources should be decided); 
• accrediting and supporting a number of European re ference networks in order to enable the 
mobility of medical expertise. 
These ERNs already exist: eleven pilot ERNs for rare diseases have been funded by the former 
Health Programmes, but following the same logic as  the ERNs that will be put in place in the 
context of the Cross-border Heal thcare Directive. The aim is: 
• to put in place an improved codi ng and classification system for ra re diseases, as part of the 
ongoing revision of the Internati onal Classification of Diseases  (ICD) to be adopted by the 
WHO in 2014, and contribute this to a WHO-base d global approach, in  collaboration with 
other internati onal partners; 
• to continue developing ORPHANET, the central  European database on rare diseases, to 
extend its treatment facilities and its scientific, language and health system coverage to all rare diseases as far as technically possible; 
• to continue providing more suppo rt to Member States  in developing thei r national strategies: 
the Council Recommendation on action on rare  diseases commits Member States to 
developing national plans, including common Eu ropean elements, to f acilitate cooperation, 
but this is technically ch allenging for any country;  
• building on the EUROPLAN project, to provide technical support and assistance to Member 
States and neighbouring countries in developing and implementing their plans and strategies 
and provide practical links betw een them to maximise European cooperation and efficient use 
of resources. 
3.2.2. Strengthening collaboration on pa tient safety and quality of care  
The Programme will strengthen the EU collaboration on patient safety and quality of care 
initiated by the joint acti on in 2011 with two goals: impl ementation of the Council 
Recommendation on patient safety and struct ured exchanges of knowledge about quality 
assurance systems. The ultimate aim is that by 2020 Member States will have jointly developed 
and implemented a selected set of guidelines and tools to promote patient safety and healthcare 
quality. 
                                                
 
29 Directive 2011/24/EU of the European Parliament and of  the Council on the application of patients’ rights in 
cross-border healthcare 
 
 21The position of the patient can be strengthened in order to achieve better healthcare outcomes. 
Patients can be empowered to manage their hea lth and, partly, their h ealthcare. For this, the 
transparency of healthcare activities and systems a nd the availability of information to patients 
should be optimised and healthcare practices s hould learn from the feedback from and inter-
communication with patients. 
3.2.3. Improving the prudent use of anti microbial agents in human medicine   
The Programme will strengthen the EU coordi nation in the form of supporting, in close 
cooperation with the food safety and animal hea lth authorities, implementation of the Council 
Recommendation on prudent use of antimicrobial  agents, to allow better alignment of the 
national strategies against antimicrobial resistance and increase the positive impact which these national measures are expected to have on the sp read and burden of antimicrobial resistance. 
It will offer EU support to facilitate exchanges of best practice and information and to enhance 
implementation of the Council Recommendation on pa tient safety, including HCAI, to increase 
the cost-effectiveness and impact of the national measures against HCAI. 
3.3. Policy objective 3: Promoting good heal th and preventing diseases to improve 
citizens' health  
Prevention of diseases and promo tion of health contribute to incr easing 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 invest ment to promote health and prevent diseases 
is one of the most cost-effective means of stimula ting 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 w ill be able to continue 
contributing to the economy as th ey grow older - as workers, volunteers and consumers. The 
expertise of the elderly will also be needed ev en more in a population with low birth rates and 
lack of skilled labour. 
To achieve this, the Programme will: 
 
Specific objective 3:  identify, disseminate and promot e 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 we ll as HIV/AIDs, with a focus on the cross 
border dimension, in order to prevent diseases and promote good health  
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.  
3.3.1 Cost-effective promotion and prevention measures addressing risk factors and 
underlying health determinants  
There is considerable evidence on the most accessible and effective measures that can be 
promoted in this context to reduce the impact of  major health determinants such as alcohol, 
smoking, diet and behavioural factor s. These risk factors can only be effectively addressed across 
 
 22society if, at the same time, underlying socio-ec onomic factors, such as  health inequalities, 
mental health and well-being, and environm ental factors are also taken into account. 
Addressing nutrition, obesity, po or diet and alcohol-related harm; increasing the rates of 
participation in physical activity for children and adults; reducing exposure  to tobacco smoke and 
developing platforms on prevention agains t smoking (to replace the ongoing anti-tobacco 
campaign); and ongoing support on eff ective prevention of HIV/AIDS. 
The aim is to help develop the contribution made  by policies and activities at EU, Member State 
and local levels and the activities of key stak eholders — including employers, non-governmental 
organisations, economic operators and other inte rest groups — into more comprehensive and 
effective efforts to prevent diseases and promote health. 
Finally, the goal will be to support and accelerate the take-up of best practices by Member States 
and allow further large-scale preventive measures by: 
• supporting EU strategies in these areas; 
• fostering effective cooperation between Member States; 
• establishing a validation mechanism, at EU  level, that will show how practices and 
community-based intervention can be assessed w ith a view to sustainable implementation at 
the level of whole populations; 
• supporting adequate dissemina tion and evaluation methods. 
3.3.2. Chronic diseases 
The Programme will provide support for studies and models of good practice addressing the key 
issues identified in the Council Conclusions on innovative approaches fo r chronic diseases in 
public health and health care systems. Thes e include: health promotion and prevention, 
healthcare – including the development and di ssemination of innovative chronic care models, 
information and research. 
It will also support with the aim of establishing standards on good practices for treatment of 
dementia and other neurological impairments, including care models, increasing attention to 
dignity, autonomy, rights and social inclusion. 
3.3.3. Cancer 
The action will be concentrated on the developm ent of high-quality population-based organised 
screening programmes for breast, cervical and co lorectal cancer aiming at very high population 
coverage. It is set out in the Counc il Recommendation on cancer screening. 
The Programme will also support the update/revisi on of the EU cancer-scr eening guidelines and 
the development of further, science-based Euro pean guidelines for scal ed-up cancer prevention. 
3.4. Policy objective 4: Protecting citize ns from cross-border health threats  
In the recent past, the EU has faced several major cross-border threat s to health, such as 
pandemic influenza or SARS. EU competence as  regards co-ordinatin g 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 nationa l 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.  
To achieve this, the Programme will: 
 
 23Specific objective 4:  develop common approaches and de monstrate their value for better 
preparedness and coordination in health emerg encies in order to protect citizens from 
cross-border health treats 
In order to minimise the public health conseque nces of cross-border hea lth threats which could 
range from mass contamination caused by chemi cal 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 reinforce d. Due to the nature of these threats, coordinate d public health measures 
at EU level are needed to ad dress different aspect s, building on preparedness and response 
planning, robust and reliable risk  assessment and on a strong ri sk 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 ligh t of the ‘one health’ concept and with a view to 
the comprehensive framework on health secu rity that is currently being developed. 
In this context, the future Health for Growth Programme w ould 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, ca pacity-building for ri sk assessment and training, exchanges of 
experience and best prac tice 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, det ection and risk assessment for major health 
scourges, on the basis of the legislation be ing reviewed and developed, together with 
multinational, cross-sectoral training activitie s and initiatives for prevention and control of 
communicable diseases, antimicrobial resistan ce and hospital-acquired infections, plus 
improvements in vaccination policies and strategies at EU level. 
3.5. Horizontal activities  
In addition, the Programme w ill support two horizontal activities  that cut across the policy 
objectives described above and contribute to th e main aim of the Programme, although they can 
also run independently of the existe nce of the future Health Programme. 
3.5.1. Actions required by or contributing to  the objectives of EU legislation 
All the legal obliga tions deriving from existing legisl ation and legislat ion currently under 
revision have been regrouped un der this specific chapter. Of ten, implementation of this 
legislation can also help to achieve one or more  of the objectives described above. But, contrary 
to other action financed by the Programme, in this case the Comm ission is under legal obligation 
to take these measures. (see Annex 6 fo r the indicative list of legislation). 
Following various meetings with DG BUDG and SE C GEN, these activities have been split 
between the 4 objectives listed above. They ar e grouped per these objec tives in the following 
section. 
SPECIFIC OBJECTIVE 1: 
 
 24Medical devices30 
The objective is: 
• To manage, implement and develop the legi slation on medical devices for human use, 
including in vitro  diagnostics in order to to ensure the safety and clinical performance of 
medical devices placed on the EU market. 
The existing directives are currently being fundam entally revised with the aims to ensure EU-
wide, uniform high level of protection of huma n health and safety, to provide a regulatory 
framework which supports i nnovation and the competitiveness of the European ‘medtech’ 
industry, to enhance the transp arency of the regulatory system and to ensure the smooth 
functioning of the internal market for medical devices. 
In addition, synergies ca n be created between implementation of  the legislation in this area and 
other activities within the Programme which would contribute to specific objective 1 by 
supporting the development of medical technologi es which could contribute to mitigating the 
shortage of healthcare profe ssionals and to the sustainabi lity of healthcare systems.31 
SPECIFIC OBJECTIVE 2: 
 (a) Substances of human origin (blood, tissues, cells and organs) 
The objectives are: 
• To monitor and support Member States with im plementation of the current EU legislation 
on the safety and quality of subs tances of human origin (SoHO). 
• To follow up innovative scientific and te chnological developm ents/new medical 
applications in the field of SoHO in order to update the legislation on quality and safety. 
• To support Member States in their efforts to  improve donation, vigilance and surveillance, 
to identify and share best practices in th e field of SoHO and to increase access for 
European patients to SoHO therapies. 
In addition, synergies can be created between  implementation of the legislation and other 
activities within the Programme which would c ontribute to specific objective 3, healthcare 
quality and patient safety, by providing guidanc e to Member States on good implementation of 
legislation, including technical details. 
(b) Patients’ rights in cross-border healthcare 
The objectives are: 
• To monitor and support Member States with implementation of the new EU legislation on 
the application of patients’ rights in cross-bo rder healthcare in order to avoid further 
litigation on the issue of patient mobility  by clarifying patients’ ri ghts to access to cross-
border healthcare and to be reimbursed for it. 
• To enhance cooperation between MS in the areas of recognition of prescriptions, e-
Health, European reference networks, health  technology assessment, standards on quality 
and safety of care and cross-border h ealthcare provision in border regions. 
                                                 
30 Corresponding costs are financed under the ‘Interna l market for goods and sectoral policies’ until 2013. 
31 See Council conclusions on innovation in the medical device sector, adopted on 6 June 2011 (point 3, third 
indent), OJ C 202, 8.7.2011, p. 7 
 
 25(c) Medicinal products32 
The objectives are: 
• To meet its obligations in the medicinal pr oducts field, the Commission will be required 
to manage, maintain and implement the legi slation on medicinal products for human and 
veterinary use, including proposals for future le gislation, in order to ensure a high level of 
public health protection across the EU, based on high scientific expertise. 
Examples of action to be taken include: 
1. developing and adopting the measures for im plementing newly adopt ed legislation on 
pharmaco-vigilance and falsified medicines; 
2. establishing the list of non-EU count ries whose manufacturing standards are 
equivalent to the EU standards, i.e. that  may export active ingredients for medicinal 
products to the EU; 
3. securing the development of quality sta ndards and control methods for medicinal 
products by funding the specific activities unde rtaken by the European Directorate for 
the Quality of Medicines (EDQM ) of the Council of Europe; 
4. getting involved at international level in  establishing public health standards to 
minimise the risk of unsafe products being placed on the EU market and to maintain 
the competitiveness of the EU pharmaceuticals industry; 
5. intervening on the specific publ ic health concerns related to antimicrobial resistance. 
• To manage the decision-making process for EU authorisation of medicinal products for 
human and veterinary use, within the strict  deadlines laid down in the legislation. 
• To implement the transparency requirements  of the EU pharmaceuticals legislation, as 
illustrated by setting up and managing the EU register of medicinal products. 
Moreover, the implementation of legislation on me dicinal products would c ontribute to attaining 
the Programme's specific objective 3 on patient safety, as illustrated by the new legislation on pharmaco-vigilance (adopted in 2010) and on falsified medicines (adopted in 2011).  
SPECIFIC OBJECTIVE 3: 
Tobacco Product directive and Tobacco Advertising Directive 
The objectives are: 
• To monitor and support Member States with im plementation of the current EU legislation 
on tobacco product and tobacco advertising. 
• To regulate the marketing of tobacco products  for public health reasons and to ensure 
appropriate consumer informa tion and harmonised standards. 
• To follow up innovations and developments in tobacco products and its advertising in 
order to update the legislation. 
In addition, synergies can be created between  implementation of the legislation and other 
activities within the Programme which would cont ribute to specific objective 4, on prevention 
measures, by providing guidance to Member St ates on good implementation of legislation. 
                                                
 
32 Corresponding costs are financed under the ‘Interna l market for goods and sectoral policies’ until 2013. 
 
 26SPECIFIC OBJECTIVE 4: 
 (c) Health Security Initiative  
The objective is: 
• To improve public health pandemic and generic preparedness and response following 
lessons learned from past ev ents, including the 2009 pandemic. 
3.5.2. Health information and knowledge: to co ntribute to evidence-based decision making, 
including collecting and analysing health da ta and wide-ranging dissemination of the 
results of the Programme 
Following various meetings with DG BUDG and SE C GEN, these activities have been split 
between the 4 objectives listed above in propor tion to their contribu tion to the objectives. 
A fully operating European health  monitoring system can provide  added value in the form of 
information allowing comparisons, which can in turn support identific ation, dissemination and 
application of best practices while also highligh ting critical areas to be improved. This also helps 
the EU, the Member States and other regional players to support health systems not only by 
highlighting critical areas to be improved but also  by detecting health-relate d obstacles to growth. 
Harmonised collection of comparable data also helps to reduce the admi nistrative and economic 
burden on Member States by reducing multiplicati on of data provision. Only a system operating 
at European level will be able to identify differences in health outcomes as a result of circumstances created by national policies, at both geographical and socio-economic levels, and 
therefore to tackle them effectively. Also, the EU  is the leading player able to enforce data 
collection effectively at national level. Ideally, a health monitoring system will also provide a 
means to measure the impact of future health initiatives at EU level. 
This objective could be met by mobilising internet  platforms, developing and regularly updating 
sets of health policy-relevant  indicators, harmonised with the WHO and OECD, which implies 
working on defining, constructing and disseminati ng these indicators on health status, health 
systems, social determinants of health and he alth promotion. Such action could also include 
releasing reports and ad-hoc  analyses on specific issues of political, economic and social 
relevance involving scientific  networks and advice groups. 
Data and evidence to be produced will be linked to and depend on the broad overarching policy 
objectives of the Commission in th e area of health, with particular attention to support for the 
sustainability of health systems. Within these obj ectives, priority will be given to information and 
evidence in areas where (a) the gr eatest EU added value can be dem onstrated and (b) a real lack 
of EU-level data is making it difficult to set or achieve specific policy objectives. 
In addition, results of the planned assessment of the use of health i ndicators at EU level will be 
taken into account in  setting priorities. 
Also, there is a need for independent, high-quality  scientific advice on health and environmental 
risks in order to support rele vant policymaking, identify res earch priorities and provide 
monitoring and guidance on new and emerging health and environmental issues. This is currently 
being done by the Commission’s Scie ntific Committees and will be continued in the next 
Programme. The objective is to be a centre of scie ntific excellence for the EU and internationally. 
Wider dissemination of the results of the EU Hea lth Programmes, in particular targeting policy 
makers, stakeholders and health professionals , was identified in diverse evaluation as an 
important area for improvement. This can be done via development of the de dicated IT tools, like 
 
 27the EU Health Portal, as well as through dedicated actions (pub lications, brochures, road shows 
etc.) and information campaigns in close c ooperation with Member States themselves.  
3.6. Context of the Programme  
The proposed Programme can contribute to addr essing the above-menti oned policy objectives 
only to the extent that it offers financial opportunities to build and launch 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. It is therefore important to underline the framework within which the EU 
action can take place effectively and provide an account of its i nherent limitations.  
First of all, the Programme cannot replace Member States’ action . Instead, as stated in 
Article 168 of the Treaty on the Functioning of th e European Union, EU action must complement 
national policies and encourage cooperation between  Member States. Thus, the problems outlined 
will, for the most part, have to be  tackled directly by Member States. 
Second , the EU has to remain within the subsidiarity principle . Thus, the Programme can 
contribute only where Member States could not act individually or where coordination is the best 
way to move forward. It is acknowledged that hea lth 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 a nd natural. The 
EU will therefore intervene, preferably, where it can promote and steer this coordination at 
European level, while also serving the interest s of the Member States and of the wider public 
health agenda. 
Third,  as explained in the section on the policy context, the Commission is committed to 
delivering on Europe 2020 goals . This implies that the Program me also has to contribute to 
achieving these goals. Still in line with th e EU 2020 objectives, the action taken in the 
Programme must prove to have real EU  added value and a measurable impact. 
Fourth  factor is related to the fact that EU financial intervention is limited by the size of the 
Programme : in budgetary terms, this  is undeniably a small to  medium-sized programme, 
although, at the same time, othe r funding programmes also contri bute to improving public health 
in the EU, most notably the public health com ponent of the Research Programme and of the 
Structural Funds. However, the Health Progr amme 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. Its success ca n be magnified by forging the 
necessary links and clear synergie s with other spending programmes. 
Finally, the Programme should meet the needs and expectations expressed by the Member States 
and stakeholders, as long as they also  fit into the framework outlined above. 
 
3.7.  Link between health challenges, MFF announcements, policy ob jectives, specific 
objectives and Programme actions  
The table below summarises these links. 
   
 
 28 
 
 29Develop common 
tools and 
mechanisms at 
EU level to 
address shortages 
of resources 
(human and 
financial)   
Develop and 
disseminate 
validated best 
practices for cost-
effective prevention 
measures  
 Develop and 
increase access to 
medical expertise 
(European 
reference 
networks) and 
information 
beyond national 
borders Develop common 
approaches and 
demonstrate their 
value for better 
preparedness and 
coordination in 
health 
emer gencies
Major and 
chronic 
diseases  Health 
workforce 
needs and 
planning 
HEALTH LEGISLATION
(medicinal products, medical 
devices, blood, tissues, etc., 
Cross-border Healthcare 
Directive, Health Security 
Initiative, tobacco control)  HEALTH   
INFORMATION AND KNOWLEDGE 
AREA 
(Risk assessment, EU health 
monitoring system)  Develop shared 
solutions and 
guidelines on 
healthcare 
quality and 
patient safety 
Communicable 
diseases and 
vaccine-
preventable 
diseases)  Rare diseases,
extended EU 
reference 
networks 
 Promote good 
health and prevent 
diseases  
HTA, 
genomics  , 
Health  
investment
E-Health  Defined Risk 
factors  
and risk 
populations 
AIDS/HIV, Health 
Security  
Initiative 
… Innovative, 
efficient and 
sustainable 
health systems           ‘H EALTH IS THE GREATEST WEALTH ’ (Virgil, 70-19 BC) 
Stakeholders’ 
involvement 
Cooperation with third
 countries  
Health inequalities More access to better 
and safer healthcare 
for EU citizens  
Patient safety 
and quality of 
systems  ti-
microbial 
resistance 
(AMR), 
HCAI Protect citizens 
from corss-border 
health threats  
 
 30 
Policy 
objectives Specific objectives The overall health 
challenges The announcements 
in the MFF 
 
Financial sustainability 
of health systems sustainability of 
health services while 
encouraging health innovation 
- a common EU 
approach to health 
technology assessment 
(HTA) 
  
Contributing to 
innovative, efficient and 
sustainable 
health systems To develop common tools and 
mechanisms  at EU level to 
address shortages of resources, both human and financial and 
facilitate the up-take of 
innovation in healthcare. Actions: 
1. Health Technology 
assessment 
2. Health innovation and e-
Health 3. Health Workforce 
4. Better decision making on 
health systems reforms 5. Support to the European 
Innovation Partnership on  
Active and Healthy Ageing   
 
 
Health workforce shortages sustainability of 
health services while 
encouraging 
innovation in health 
 
 
Increasing access 
to better and safer healthcare 
for EU citizens To develop and increase access 
to medical expertise ( European 
Reference networks ) and 
information beyond borders 
and to develop shared solutions 
and guidelines to improve 
public health, healthcare 
quality and patient safety  
Actions: 
1. Setting up accreditation and 
support of European Reference 
Networks 
2.Strengthening collaboration 
on patient safety and quality of care 
3. Improve the prudent use of 
antimicrobial agents in medicine 
 
 Improvements necessary 
in patient safety  sustainability of 
health services while 
encouraging health innovation 
- Rare diseases  
- supporting European 
reference networks on 
diseases 
increase the 
sustainability of 
health services 
 
Promoting good 
health and 
preventing 
diseases to improve citizens' 
health To identify, disseminate and 
promote the up-take of 
validated best practices  for 
cost-effective prevention  
measures; 
1. Cost-effective promotion and 
prevention measures addressing risk factors and 
underlying health determinants 
and health promotion 
2. Chronic diseases 
3. Cancer  Lack of sustained 
progress on control and 
prevention of chronic 
conditions   
Loss of best productive 
years  (slow increase in HLY) to improve the health 
of the population
 
(cancer as an example in 
MFF) 
 
increase the sustainability of 
health services 
 
No policy 
objective  
No specific objective 
No actions 
   
      (Increasing 
inequalities) 
Addressed only partially 
as side effect of the specific objectives  Not in the MFF  
 
 31Protecting 
citizens from 
cross-border 
health threats To develop common 
approaches  and demonstrate 
their value or better 
preparedness and 
coordination in health 
emergencies  
Actions: 
1. Preparedness and response 
for serious cross-border health 
threats 2. Risk assessment capacity 
3. Support capacity building 
against health threats in 
Member States  Global and cross-border 
threats  to protect citizens 
from cross-border 
health threats  
 
 
 324. S UBSIDIARITY TEST – THE RIGHT OF THE EUROPEAN UNION TO ACT  
4.1. Legal basis  
Article 168 of the Treaty strongly reasserts 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 ac tion 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, 
• improving the complementarity of the Member Stat es’ health services in cross-border areas. 
The same article also suggests wa ys to contribute to the fight ag ainst the 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 subparagra ph of Article 168(2) states that ‘ The Commission may, in 
close contact with the Member States, take any usef ul 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 th e competent international organisations in the 
sphere of public health .’ 
Against this background, Article  168(5) TFEU empowers the Eu ropean Parliament and the 
Council to adopt incentive measures to  protect and improve human health. 
4.2.  Necessity test  
While Member States are sovereign to tackle the above-mentioned problems and to decide on 
their national health policies, in a number of cas es they can only take ac tion after coordination at 
EU level. For some countries, the cooperation betw een Member States is pa rticularly beneficial. 
There is a better chance of solving global issu es and common concerns by mobilising efforts at 
EU level and establishing common values and principles. 
The Programme will, in particular, fund action that cannot be carried out as effectively by 
Member States themselves but depends greatly on cooperation at EU level. 
 
 
 33Here are some examples of such actions:  
Under specific objective 1.  Health Technology Assessment (HTA):  
Improving cost-effectiveness of he alth systems is a key intervention area in order to ensure 
overall sustainability of health expenditure in an  environment of reduced resources and capital. In 
this framework, Health Technology Assessment ca n, y identifying resource -effective, safe aand 
effective intrventions, provide he alth decision-makers with an evidence-based and transparent 
basis for decisions on the uptake and phase-out of  health technologies, optimizing use of health 
budgets and providing best treatment to patients.  HTA is a important tool but unfortunately 
related resources, knowledge and expertise are uneven ly spread in Europe. EU action in this area 
could provide economies of scale, insofar co mmon methodological standards for the assessment 
of different health technologies lead to simp lified sharig and re-use of HTA information 
generated.  
Under specific objective 2. European Reference Networks (ERNs) in the area of rare 
Diseases: 
There is a high overall burden of rare Diseases , in terms of significant morbidity, premature 
mortality, loss of quality of Life , with extended impact beyond patients, to the socioeconomic 
potential of family members (oft en acting as fisrt line carers) a nd wide community, due to costly 
management.  Low prevalence, as well as low nu mber of patients by diseases and per Member 
State leads to large variance in access to diagnosis, to quality care and ultima tely, to treatment for 
lack of available information on and training about the diseases. The limited number of patient 
and scarcity of knowledge and expertise at memb er sattse level gives hi gh potential added value 
to Eu level action. The Programme could s upport generation, transl ation, validation and 
dissemination of knowledge and information in this area.  
Under specific objective 3. Revision of the EU cancer-screen ing guidelines for high-quality 
screening programmes for breast, cervical and colorectal cancer33 and treatment:  
In the fight against cancer, EU  cooperation has alre ady proven its added value. A study in 2003 
showed a reduction of 9 % in expected cancer deat hs and of 10.5 % in the risk of cancer death 
between 1985 and 2000 and conc luded that the ‘Europe Agai nst Cancer’ Programme (1987–
2000) had contributed to these results. The Commission has theref ore decided to continue to 
support Member States in this area: one of  the objectives set in its 2009 Communication on 
‘Action Against Cancer: European partnership’ 34 is to reduce cancer  incidence by 15 % by 2020.   
Under specific objective 4: Reference Laboratories for highly pathogenic agents: 
Europe is facing continuous threats related to emergent communication dis eases, with natural or 
intentional release as illustra ted by several events  caused by highly pathogenic agents in the 
recent past (H5N1, Chikungunya, H1N1, E.coli etc). Su ch threats will by defi nition not stop at 
borders and preparedness and response depends on timely and accurate identification of the 
specific agent. The laboratory preparedness among EU Member states is heterogeneous, with 
some laboratories using well-established methods  for the identification of highly pathogenic 
bacteria and virus (Bio -safety group 3 and 4). 
The development of the European laboratories of  reference network with individual laboratories 
covering more than one Member State has increased the return on investment, while the cost of 
creating such highly specialised la boratories at individual EU Memb er sate level was prohibitive.  
                                                 
 
34 COM(2009) 291 final of 24 June 2009: 
http://ec.europa.eu/health/archive/ph_information/dissemination/diseases/docs/com_2009_291.en.pdf. 
 
 34More examples can be found in Annex 7.  
By definition, as previous experience has demonstrated, Member States do not have always the 
possibility, neither financially nor  scientifically, to act on their own in these areas. In addition, 
some health issues have an increasing cross-bo rder dimension which can only be addressed at EU 
level. 
The first line of beneficiaries of the Programme will be health policymakers and health 
professionals, patients’ organisations and other ci vil society organisations. EU citizens will be the 
ultimate beneficiaries. Given the broad spectrum of stakeholders, it is crucial that the Programme involves all of them and supports not only public bodies but also the non-governmental 
organisations at EU and national levels which, during the crisis, ar e facing particular challenges. 
Emphasis should be given to stakeholders from  Member States with low GNI who remained 
inactive during the previous H ealth Programmes and to small entities facing language problems 
and other barriers. 
The common nature of the challeng es and the opportunities for growth  as a result of better health 
make the Programme increasingly important. Its ow n particular value is as a unique bridge 
between technological innovation, soci al policy and practice. Its speci fic objectives aim to have a 
catalytic effect and help the parties involved fi nd the most suitable and effective solutions. The 
Programme will provide a significant complement to national programmes together with other 
EU Programmes and policies such as the Stru ctural Funds and the Research Framework 
Programme. In particular, the Programme will offe r significant scope for connecting research to 
policy, practice and implementa tion and developing innovative knowledge transfer throughout 
Europe, including possibly neighbouring and ot her non-EU countries. For the above-mentioned 
reasons, the outcome of the Programme will be un ique and should be disseminated strategically. 
4.3. EU added value
 
European added value is the value that EU acti on adds to the value that would otherwise have 
been created by Member States acting alone or by  action contributing to objectives more specific 
to the Commission. The concept of European adde d value plays a key role  in the assessment of 
subsidiarity where, in the areas which do not fall  within its exclusive competence, the Union has 
to justify its action in terms of the additiona l value it might have ov er action by individual 
Member States.35 
The value of investing in preparedness, preventio n and coordination of measures on health threats 
and communicable diseases at EU level was cl early demonstrated by the H1N1 outbreak in 2009. 
Strengthening the capacity to manage serious cr oss-border health thre ats, along with joint 
procurement of vaccines against pandemics, is another area where significant EU added value 
can be obtained. The EU can also deliver signif icant benefits on cross- border issues such as 
cross-border healthcare and hea lth inequalities and by developing strategies to counter growing 
antimicrobial resistance, along with cost-effectiv e health technologies an d innovative healthcare, 
and promoting healthy ageing with the ai d of a European Innovation Partnership. 
Action under the Health Programme complements and adds value to Me mber States’ action on 
health promotion and prevention of illness (i ncluding work on, for example, nutrition and 
smoking and on reducing inequa lities in healthcare), protection of  citizens against health threats, 
                                                 
35 While there is no Treaty obligation to assess the European added value in those areas falling under the Union’s 
exclusive powers, the Commission is nevertheless also strivi ng to maximise the effectiveness and efficiency of its 
action in these fields. 
 
 35in particular pandemic preparedness, the safe ty of medical products, blood, tissues, cells and 
organs, and cooperation between health systems. 
Some examples of actions with  the proven EU added value: 
• Understanding rare diseases and developing innovative treatment for them requires pooling 
patient populations in European registers across several countries; many such measures 
depend critically on the Health Progra mme if they are to take place.  
• Cooperating on cross-border diseases such as H1N1 flu also cannot be undertaken by 
individual Member States, but de pends 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 the Member States an d of non-EU countries to respond to these 
threats. Providing a rapid and c oordinated answer to global hea lth threats is also the EU’s 
role. 
• The Health Programme has deve loped and strengthened networks between European health 
specialists, national and regional health auth orities and other stak eholders who greatly 
contribute to sharing knowledge and building h ealth capacity in the EU. It has also built 
consortia, partnerships and other ways to interchange information and practices across 
Europe, thus boosting cooperation and the pace of research. The outcome of the projects and 
action funded by the Public Health  Programme is the most effec tive, if not the only, way to 
build the evidence base for defining much br oader regulatory policies (for instance, on 
cancer, Alzheimer’s, rare diseas es 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 (see more in Annex 7) most of the following EU added value criteria 
were developed on the basis of th e subsidiarity principle and Artic le 168 of the Treaty 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. 
It is intended to extend the use of  these EU added value criteria in  both prioritising the actions to 
be funded in the new Programme and in the sel ection process for the annual calls for proposals 
and to use them a posteriori  as well. 
The table set out below sums up the EU added valu e expected in relation to the objectives of the 
Health for Growth Programme.  
 
 36     
Specific 
objectives 
 
 
  Develop  
common tools 
and 
mechanisms at 
EU level to 
address 
shortages of 
resources 
(human and 
financial) and 
facilitate the up-
take of 
innovation in 
healthcare  Develop and 
increase 
access to 
medical 
expertise (EU 
reference 
networks) and 
information 
beyond 
national 
borders  Develop shared 
solutions and 
guidelines to 
improve healthcare 
quality and patient 
safety Identify, 
disseminate 
and promote 
the up-take of 
validated best 
practices for 
cost-effective 
prevention 
measures Develop common 
approaches and 
demonstrate their 
value for better 
preparedness and 
coordination in 
health emergencies    
EU added 
value 
 Addressing certain 
issues relating to 
the internal 
market  where  EU 
has substantial 
legitimacy to 
ensure high-quality 
solutions across 
EU Member 
States;  unlocking 
the potential in 
innovation  in 
health; provide 
high-value services 
while achieving 
economies of scale  
and avoiding waste 
due to duplication, 
with the aid of 
common HTA at 
EU level.  
 Stronger 
knowledge base 
networking 
Pooling resources 
and expertise to 
address issues 
(e.g. rare 
diseases) which 
Member States 
cannot deal with 
individually in a 
cost-effective 
manner.  
Unlocking the 
potential in 
innovation  in 
health. 
Reference 
networks are sure to bring 
economies of 
scale  by means of Stronger knowledge 
base networking 
Economies of scale 
Issues are often similar 
in all countries, but 
resources are limited. 
The process can be 
better staffed at EU 
level (for resources and 
statistical reasons).  
Unlocking the 
potential in 
innovation  in health.  
Benchmarking for 
decision-making  
There is great potential 
for Member States to 
learn from each other’s 
good practice and 
implementation 
strategies. By doing so, 
there is a chance of Promotion of best 
practice 
Demonstrate the 
value of action 
taken at the level 
of various large 
populations in 
order to provide 
more evidence on 
practices and ways 
to implement 
action. Cross-border threats 
This area has high added 
value. The objective is to 
reduce the risks and 
mitigate the 
consequences of health 
threats that develop 
across borders in a 
multi-interdependent 
EU. Individual threats 
also determine the 
targets. Increases in 
performance will be measured by assessing 
preparedness and 
evaluating performance 
during crises. 
   
 
 37 concentration of 
skills and 
knowledge. reducing health 
inequalities between 
EU Member States  
 
 385. L INKS BETWEEN THE HEALTH FOR GROWTH PROGRAMME AND THE EU 2020  
STRATEGY  
Promoting health is an integral part of the smart and inclusive growth  objectives of Europe 
2020 agenda. The objectives set for the Programme are tailored to the needs of Member States in 
order to make progress against specific targets.36 
5.1. Provide innovative solutions for improving  the quality and sustainability of health 
systems  
According to the Joint Report on Health System s prepared by the European Commission and the 
Economic Policy Committee/Working Group on Ageing (AWG),37 health systems need to be 
monitored rigorously and, where needed, reformed to ensure greater cost-efficiency and sustainability, especially considering demographic ageing.  By investing in innovative solutions 
for improving the quality and sustainability of hea lth systems, the Programme supports take-up 
by Member States of reforms in the health sector which are necessary to ensure its sustainability 
and contribute to economi c recovery. In addition,  health systems are also a driving force for 
economic growth and innovation by improving the health of the population and by virtue of their role as major employers and users of new technologies. 
Innovation in health is crucial to Europe. Ke y European goals, set out in the Europe 2020 
Strategy, on economic growth and development,  European competitiveness, job creation, 
healthcare and quality of life, all hinge on continued and increasing innovation in healthcare in Europe. However, innovation is not just about technology and new products,
38 but also about 
people, management of expectations a nd improving organisational efficiency.  
Innovation in health has unique potential, not only as a possibly powerful driver of socio-
economic development, economic growth and high- value jobs, but also in terms of reducing 
healthcare costs and increasing the quality of care to patients. Many areas of the Programme, 
such as health technology assessment, medical devices and medicinal produc ts or public health 
genomics, aim to strengthen the link between tec hnological innovation and commercialisation, 
while ensuring security, quality and efficiency . Other initiatives ar e focusing on e-Health 
solutions and fostering interoperability at EU leve l in order to increase for example cross-border 
use of patient registers. They also serve HTA, clinical trials and quality of care. 
Finally, the contribution made by the Programme to better planning of needs and training of the 
health workforce also contribu tes to both organisational innova tion and inclusive growth. The 
expected benefits fit in with the Agenda for new skills and jobs (flexibility and security; 
equipping people with the right skills for the jobs  of today and tomorrow; improving the quality 
of jobs; ensuring better worki ng conditions; and improving the conditions for job creation). 
5.2. Support and complement the efforts of Me mber States to increa se the number of 
healthy life years of the EU population  
Keeping people healthy and active for longer has a positive impact on productivity and 
competitiveness. Increasing the number of healthy lif e years is a prerequisite if Europe 2020 is to 
succeed in employing 75  % of the working-age population ( 20-64 years) and avoiding early 
retirement due to severe illness or invalidity . Keeping even the more elderly population (for 
instance, those between 64 and 74  years) healthy and active pr ovides a crucial boost to the 
economy, with an impact on the labour market. Wh ile it has long been recognised that increased 
                                                 
36 Member States have agreed on a new EU-level economic  governance structure, the ‘European semester’, which 
helps them to coordinate their macro-economic , budgetary and structural reform policies. 
37 December 2010: http://ec.europa.eu/economy_finance/ publications/occasional_pape r/2010/pdf/oc p74_en.pdf. 
38 See Council conclusions on innovation in the medical devi ce sector, adopted on 6 June 2011, OJ C 202, 8.7.2011, 
p. 7 
 39national  wealth  is associated  with improved  health , only more  recently  has the contribution  
which better health makes to ec onomic growth been recognised.  
Lacking the proper facilities to im prove the health of the population,  to prevent and treat diseases 
and injuries and to reintegrate pe ople who suffered poor health back  into the labour market is an 
obstacle to economic prosperity. In its report ‘ The contribution of health to the economy in the 
European Union39
’ the Commission on Macroeconomics and Health emphasised the role played 
by health and healthcare in gene rating social cohesion, a productiv e workforce, employment and, 
hence, economic growth. 
6. P OLICY OPTIONS  
6.1. Options considered  
The option involving no resources at all  was not considered. After all, without credits the 
Commission would simply not be able to fulfil  its obligations stemming from the Treaty and 
existing legislation. This acti on cannot be funded from cred its secured under specific budget 
lines. Until 2013, it will be financed under the cu rrent Health Programme and the ‘Internal 
market for goods and sectoral policies’. 
For instance, the EU pharmaceutical s legislation provides for the Commission to adopt decisions 
on marketing authorisations for medicinal produ cts for human and veterinary use (Regulation 
(EC) No 726/2004).40 In addition, the transp arency requirements of  the EU pharmaceuticals 
legislation require establishment and management of a Union's register of medicinal products. 
These decisions are prepared on the basis of the scientific evaluations by the European 
Medicines Agency, using a database. In 2010 al one, the Commission adopted 1279 decisions in 
this area. Given the number of decisions and their volumi nous scientific annexes, the 
Commission would not be able to fulfil its obligations without a system for electronic 
management of the decisions. This cannot be put in place and ope rated without funding. 
Moreover, the Commission has also set up a European databank on medical devices (Eudamed)41 
in accordance with Directive 93/42/EEC. All Member States are required to upload certain data 
regarding manufacturers, me dical devices, vigilance reports and clinical investigations in this 
databank, so that the information can be shared  between the national au thorities. Eudamed will 
be further developed to establish it as the cen tral and publicly accessible EU registration and 
listing database for economic operators and medi cal devices, integrating a function for tracing 
medical devices by means of a unique device iden tification (UDI). The future Eudamed will thus 
ensure a high level of transparency in the fiel d of medical devices pla ced on the EU market, but 
significant financial resources wi ll be required to develop the necessary IT infrastructure. 
The Impact Assessment report analyses the following options for the future Programme:  
Option 1  corresponds to the absolute minimum of ac tions 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 orig in, patients rights in cross borde r healthcare, Health security 
(cross border health threats) and tobacco. 
                                                 
39 http://ec.europa.eu/health/ph_overview/Documents/health_economy_en.pdf. 
40 EU pharmaceuticals legislation also provides for the Co mmission to adopt decisions on subsequent amendments 
to these authorisations (Regulation (EC) No 1234/2008), decisions addressed to the Member States on action to be taken as regards medicinal products for human and veterinary use authorised by the national authorities (Directives 
2001/82/EC and 2001/83/EC) and regulations on maximum residue limits for veterinary medicines in food of animal 
origin (Regulation (EC) No 470/2009). 
41 See Commission Decision 2010/227/EU on the European Databank on Medical Devices (Eudamed) 
 40Option  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 a dded value and with better mon itoring 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 sustai nability of health systems, 
• prevention of diseases at EU level by he lping 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 ot her means than the resources 
of the Programme and limited to devel opment of working methods and policy 
evaluation. 
• supporting and complementing Member States e fforts 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 o ff. This programme would be focused on: 
• supporting actions required by the current EU health and internal market legislation, 
• supporting the up-take of  innovative soluti ons for improving specific points concerning 
the quality, efficiency and sustainability of health, 
• supporting and complementing Member States e fforts 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 related legislation and to supporting so lutions for cross border health 
threats. In addition, there would be some disse mination of the results of the current Health 
Programme (2008–2013) in order to take into account the conclusi ons of previous evaluations, 
Option 4 corresponds to a well-structured  programme focusing on the sa me issues as option 3 a) 
but adding a specific objective for addressing wi der, social and economic, causes of health 
inequalities by appropriate financial means. This  option would imply a significant increase of the 
envelope for the Programme. 
6.2  Option 1  
The first option would be to focus exclusively on  support based on a strict  interpretation of the 
current obligations of the Commission, which are:  implementation of the health and internal 
market legislation plus dissemination of the results of the current Health Programme (2008–
2013) in order to take into account the reco mmendations made by previous evaluations. 
In this case, the Commission would concentrat e on actions required by or contributing to the 
objectives of EU legislation already existing or currently being prepared or revised on: 
• medicinal products; 
• medical devices; 
• substances of human origin (b lood, tissues, cells and organs); 
• patients’ rights in cr oss-border healthcare; 
• tobacco product and tobacco advertising directives; 
• the Health Security Initiative. 
 416.2.1. Consistency  with  the announcements  of the MFF  communication   
The announcements, which predefine the scope of the new Health Programme, state that " the 
programme will support health policy by developing best practices and guidelines for the 
diagnosis and treatment of rare diseases, supp orting European reference networks on diseases, 
developing best practices and guidelines for cancer screening and developing a common EU 
approach to health technology assessments and e-Health ." 
Under this option, none of thes e actions would be undertaken. 
6.2.2. Contribution to the EU 2020 strategy 
Under this option, the Programme would not be contributing to: 
- the smart growth objective, as it would not be supporting th e implementation of innovative 
solutions and techniques in the area of health; 
 - the sustainable growth objective by not suppor ting MS in finding sustainable solutions for 
healthcare systems, including prevention; 
 - the inclusive growth object ive by not working on the health workforce shortage problem. 
6.2.3. Improvement of the design and monitori ng of the Programme as recommended in 
the evaluations 
The implementation of the recommendations made would be of a limited magnitude as these 
recommendations are mainly about the design of the Programme, and this option means that 
there is no more programme, only very punctual individual actions, mainly dissemination of past 
results and support for the actions required by or contributing to the objecti ves of EU legislation. 
This would of course no t prevent from having indicators and a monitoring system to be able to 
measure achievements made in the implementation of the legislation. 
6.2.4. Achievement of objectives , thus of the programme 
(a) Loss of investments made in previous Programmes: 
The inability to upgrade dissemination of the resu lts of the current Health Programme will lead 
to the situation where most of them would actua lly be lost. For instance, common guidelines for 
cancer have been developed thanks to the Pr ogramme and are now bei ng applied at national 
level. Failing to update them at regular interval s on the basis of scien tific developments and 
assessments would deprive Member States a nd health practitioners  of this benefit. 
(b) Possibility of a regression in areas where MS cannot tackle issues alone: 
Under this option, actions that cannot be taken e ffectively by Member States alone but depends 
greatly on cooperation funded at EU level woul d not be funded anymore. One example can be 
the area of cross-border health threats. Fast -spreading communicable diseases do not stop at 
political borders. In such, possibl y very dramatic situations, it is important that Member States 
are well-prepared in advance an d are accustomed to cooperate as much as possible. In the 
absence of common training and ex ercises, guidelines and comp atibility among Member States' 
procedures, there is a serious risk that diseas es will spread quicker and wider, causing more 
human casualties and greater disruption for the EU economy. 
Another example can be rare diseases. Because of  the low numbers of patients in each Member 
State alone and isolated centres of expertise (som etimes just three or four across the whole EU), 
it is impossible for all Member States to provide equally high-quality expertise and care to patients with rare diseases. The pooling of expe rtise across the Union, which makes much more 
efficient use of the limited resources in this area,  is likely to be abando ned in the absence of 
continuous funding from the EU budget, denying many European citizens with rare diseases 
access to proper care if they happen to live in a country where little, if any, expertise is available. 
(c)No leverage for MS health policies: 
 42In this option , no support  would  be given  to the Member  States , in the form  of cooperation , 
sharing knowledge, exchange of best practices et c. Thus probably the degree of importance to do 
things in certain areas would decrease in Memb er States, which would, in turn, have a negative 
incidence on the sustainab ility of health systems. 
The EU Health Programme as such could not be us ed as an example or source of inspiration for 
Member States own public health programmes. Longer term goals in the public health would 
loose importance to some short term fixes, especi ally as many Member States budgets need to be 
reduced due to the financial crisis. 
In addition, under this option None  of Member States' and stake holders' concerns will be taken 
into account.  
6.2.5. Implementation of Commission's legal obli gations and synergies between the actions 
undertaken for the implementation of legisl ation and actions und ertaken in order to 
achieve different objectives 
These obligations would be fully fulfilled however no synergies could be developed as there 
would be no  programme .  
6.2.6. Impact of the simp lification measures 
The implementation of the simplification measures would be of a limited magnitude as these 
measures are mainly about the implementation of  actions (and not support to the implementation 
of legislation) which is not  foreseen under this option. 
This would of course not prevent the limitati on of activities to be funded and their size.  
6.2.7. Compatibility with the available resources 
This option would be compatible with the availabl e resources as the amount of allocations would 
be lower as the amount in the MFF communication. 
6.3 Option 2  
This option is the baseline scenario. It corres ponds to continuing the programme in its present 
form with 3 main objectives as described in the decision for the programme42: 
 - improve citizens' health security; 
 - promote health,  - generate and disseminate he alth information and knowledge. 
For each of these broad and general objectives, th ere is a long and broad list of actions in the 
annex to the decision which are not prioritised. No indicators have been provided and none can 
be found for such objectives th at would allow to measure achievements against objectives and 
thus measure the impact of the programme.  
This option implies that none or very little of the recommendations made or conclusions drawn 
in the different evaluations and audits would be fully taken into account. Indeed, some steps have 
already been taken in order to answer these r ecommendations: the number of projects to be 
financed annually has been decreased significantl y, priority areas are set internally and proposed 
funding is set against these priorities. This prio ritisation process is now being further improved 
so as to avoid criticisms made by Programme Committee Members and stakeholders in the mid-
term evaluation about the lack of transparency . Nevertheless the root causes of the problems 
would not be healed. 
                                                
 
42 See Annex to Decision n°1350/2007/EC of the European Parliament and of the Council of 23 October 2007 
establishing a second programme of Community action in the field of health (2008 – 2013), OJ L 301 p 3 of 20.11.2007. 
 436.3.1. Consistency  with  the announcements  of the MFF  communication  
Under this option, the programme 's objectives would not be aligned to these announcements. 
There would be a lack of focus on actions that  contribute to encourag ing innovation in health 
such as Health Technology Assessment or e-Health.  
6.3.2. Contribution to the EU 2020 strategy 
Indeed, implementing the future programme in the same way as the current one would imply that 
objectives, dating back to 2007, would not take in to account Commission's po litical priorities as 
formulated in the EU 2020 strategy. 
In addition, except for the impl ementation of legisla tion, the repartition of budget between the 
objectives (should be towards an equal split) w ould make it much more difficult to finance all 
the actions on HTA, health workfor ce, e-health, sustainability of he alth systems etc. and thus to 
participate significantly (on the programme's scale) in the smart, sustainable and inclusive 
growth objectives.  
6.3.3. Improvement of the design and monitori ng of the Programme as recommended in 
the evaluations 
This option would mean that none or very littl e of the recommendations made or conclusions 
drawn in the different evaluations  and audits would be fully ta ken into account. Indeed, some 
steps have already been taken in order to answer the recommendations made by the Court of 
Auditors and in the external ev aluations (number of projects to  be financed annually has been 
recently significantly decreased, priori tisation is being somehow improved).  
But in order to fully implement these recommen dations, it’s the whole de sign of the programme 
that needs to be reviewe d. It can only be done while  preparing a new Programme. 
The main results would be: 
• insufficient focus: a long list of items woul d have to be addressed with little or no 
prioritisation and time limits; 
• insufficient logic of intervention, leaving no possibility to demonstrate that the action 
taken is converging towards a given aim; 
• a lack of smart objectives and indicators, mean ing that again, the level of achievement of 
the objectives would be very difficult to m onitor, and it would not be possible to 
demonstrate  the impact of the Programme. 
6.3.4. Achievement of objectives, thus of the programme: 
The objectives of the current programme are neithe r result oriented, nor fo cused. A big variety of 
actions can be undertaken while not necessary corresponding to the real needs. Without the 
strengthening of the dissemin ation the results of many of the projects would be lost. 
As a consequence the progr amme would not sufficiently contri bute to support Member States in 
their efforts to find solutions for the challenges they are facing. 
The leverage would exist, as it currently exists according to the findings of the evaluations. 
However, the lack of focus and prioritisation of the objectives and actions would weaken the 
level of incidence on national policies. 
Finally, Member States' and stakeholders' concer ns would be taken into account only to some 
extend. 
6.3.5. Implementation of Commission's legal obli gations and synergies between the actions 
undertaken for the implementation of legisl ation and actions und ertaken in order to 
achieve different objectives 
 44These  obligations  would  not be fully  fulfilled  as the obligations  related  to medical  devices  and 
medicinal products would not be taken into account. 
6.3.6. Impact of simplification measures 
Under this option, no simplification is foreseen othe r than steps already taken in order to answer 
the recommendations made in the latest evaluations  and audits. These steps may indeed result in 
a lesser burden on administrative costs.  
6.3.7. Compatibility with the available resources 
This option would be compatible with the availabl e resources as the amount of allocations would 
be the same as the amount in the MFF communication. 
6.4 Option 3  
Option 3 follows strictly the recommendations ma de by evaluations of the previous and current 
Health programmes as well as the recommendati ons stemming from the report of the Court of 
Auditors in 2008 (see above point 2.2.1) . The highest ranked recommendations stressed the 
need:  
• to improve the concept and the design of the future Programme with an explicit 
intervention logic; 
• to focus the Programme on SMART objectives , and reduce the number of priorities  
• To better take into consideration the real n eeds and what is achievable within the limited 
budget, and 
• to support actions that will crea te proven EU added value. 
This option corresponds to a well structured programme, with SMART objectives, prioritised 
actions, creating EU added value and with be tter monitoring of outcomes and impacts. 
An idea which clearly underpins option 3 is to learn the lessons from the previous Health 
Programmes. Although this option may be equivale nt to option 2 in budgetary terms it differs 
significantly regarding the design and monitoring of the programme. Under this option, the new 
Programme would address the main criticisms made by the Court of Auditors in its report and in 
the external evaluations.  
a) Intervention logic of the progr amme, focused and smart objectives 
Specific objectives (described unde r point 4) have been determ ined in accordance with the 
review of the challenges and policy objectives . There is a clear link between them and MFF 
announcements (as shown in the table under point 3.7). 
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. This will be measured by means of appropriate SMART 
indicators in the extensive evaluation and monitoring. The activiti es supported by the 
Programme will be compatible with the overarching aims of the EU health policy that is to 
improve the performance of health systems and render them more equita ble, sustainable and 
compatible with EU 2020 objectiv es. Initiatives supported by the Programme are expected to 
produce specific outcomes. Without a valid outcome they will not be continued. 
In line with MFF announcements the priority sp ecific objectives  are the one defined in the 
section 3, namely: 
Objective 1: develop common tools and mechanisms at  EU level to address shortages of 
resources, both human and financial, and facilita te up-take of innovation in healthcare in 
order to contribute to innovate and sustainable health system  Objective 2: increase access to 
medical expertise (European reference networ ks) and information for specific areas and 
 45beyond  national  borders , and develop  shared  solutions  and guidelines  to improve  
healthcare quality and patient safety in ord er to increase access to better and safer 
healthcare for EU citizens 
Objective 3: identify, disseminate and promote the up -take of validated best practices for 
cost-effective prevention measures , in particular by addressing the key risk factors, namely 
smoking, abuse of alcohol and obesity, as we ll as HIV/AIDS, with a focus on the cross 
border dimension, in order to prevent diseases and promote good health ; 
Objective 4. develop common approaches and demo nstrate their value for better 
preparedness and coordination in health emerg encies in order to protect citizens from 
cross-border health treats . 
b) Prioritisation of actions  
The prioritising of areas of intervention and of concrete actions for fundingwill be based on: a) 
legal obligations for the Commissi on; b) the potentiality to crea te the largest European added 
value according to the determined criterias (as desc ribed in the point 4.3), c) direct links with the 
challenges/real needs and policy obj ectives, d) past experience and the results of the evaluations; 
e) the level of importance for Member States polic ies and stakeholders activities; f) size of the 
population that might be impacted, and g) what  may be achievable within the modest budget. 
As a result, some of the activities from the past  and current programmes will not be continued or 
their financing will be significantly reduced. Ot her policy areas and actions will witness their 
budget increased. Last but not least a limited numbe r of new actions will be also added taking 
into account the overall need for reduction of priorities. 
In the preferred option (see below option 3a), the total num ber of actions is reduced to 22 and the 
total number of outputs is estimated to 210.  
In line with the policy objectives the following ac tions will not be carried  out in comparison to 
the current and previous programme: incidence of environment on health, actions on prevention 
of injuries. These actions can be more e ffectively supported by other EU policies and 
programmes than the modest Health Programme. 
Following objectives and horizontal activities wi ll have their budget reduced: promotion of good 
health and health information and knowledge. The examples of concrete action to be reduced 
are: the action on mental health or  health crisis preparedness. This is because these activities can 
be supported by other EU programmes, or the Commission will concentrate on putting forward 
the legislation (Health Security Initiative), or/and much was achie ved up to now and actions can 
focus more on networking or exchange of best pr actices which are simply less costly. Promotion 
of health nevertheless remains an important part of the programme as it contributes to the prevention of diseases, such as cancer and chronic diseases and it is one of the action's which is 
the most requested by our stakeholders, especially  NGOs. The decrease of support in the area of 
health evidence and knowledge is related to the de-prioritisation of this activity, especially 
regarding the work on the definition of adequate  and pertinent health in dicators. An evaluation 
on the use of relevant EU indi cators in the context of a comprehensive European health 
monitoring system is ongoing. The acquisition, valid ation and dissemination of data can provide 
added value in the form of information a llowing for benchmarking for informed decision-
making. In addition, a harmonised collection of  comparable data may help reduce the 
administrative and economic burden on Member Stat es by reducing multiplication of such tasks. 
A number of actions from the previous programme  are continued in the new one with the same 
range of funding. They are maintained either :  
because of their recognised high level of EU adde d value (cancer, chronic diseases); because of 
the impossibility for Member States  to act alone (rare di seases and cross border health threats) or 
 46because  there  is additional  ground  work  to be carried  out in view  of further  developments  of 
existing legislation (patient safety for patients rights in cross border healthcare).  
These actions address to great exte nd the real needs, challenges a nd expectations of end-users of 
the Programme as expressed in the consultations. 
A number of actions that are now emerging in the current programme will be further developed 
in the next programme. They have been deem ed to have a high EU added value in that 
guidelines, best practices and advices develo ped with the support of the Programme could 
contribute to the sustainability and efficiency of health system s in Member States implementing 
them (on topics of health workforce, better decision making on health systems reforms, cross 
border health care). The other reason is because they deal with innovative solutions (health 
technology assessment or health innovation and e- Health). HTA for exam ple has a recognised 
potential for generating important economies of scale, notably becaus e of the size of the 
population that they may affect.  
In addition, these are al so political priorities of the Member  States and the Commission, they are 
fully in line with EU 2020 agenda to support in novation in health and in clusive and sustainable 
growth. As they are relatively new they are also more costly for Member States than for example 
an exchange of best practices with in already well established network. 
New actions under the new Health Programme are the one under support fo r the EU legislation 
on medicinal products and medical devices (transferred from Inte rnal Market bud get lines) and 
all other obligations stemming from the legi slation under preparation. Regarding medical 
devices, it will be with a much increased fundi ng compared to the years prior to 2014 as the 
directive is currently be gin revised and it is on e of the tools that will  be used to unlock the 
potential of innovation in health. 
  
Option 3 has been divided into 3 sub-options in order to take into account different levels of 
contribution to the main strategic goals, also taking into account possible trade-offs 
6.4.1. Option 3 sub-option A  
In this option, the Programme comprises full se t of policy objectives an d horizontal activities 
described under point 3. 
The repartition of credits  per policy objectives and in comp arison with the current programme in 
this option would be as follows: 
Evolution of allocations between old a nd new programme per specific objective: 
 
 Average per year  
Specific objectives 2014 – 2020 
(sub-option 3A)  2014 – 2020 
(sub-option 3 B)  difference 
1) develop common tools and mechanisms at EU le vel to address shortages of resources, both 
human and financial, and facilitate up-take of i nnovation in healthcare in order to contribute to 
innovate and sustainable health system  
Sub-total 9 24.3 15.3 
 472) increase access to medical expertise (Eur opean 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 citizen  
Sub-total 9.8 11.3 1.5 
3) identify, disseminate and prom ote the up-take of validated be st 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  
Sub-total 21.1 10.9 -10.5 
4) develop common approaches and demonstrat e their value for bette r preparedness and 
coordination in health emergenci es in order to protect citizens  from cross-border health treats  
Sub-total 7.5 4.6 -2.9 
TOTAL 47.4 51.1 3.7 
 
6.4.1.1. Consistency with the announcements of the MFF communication  
Under this option, the Programme 's objectives would be aligne d to these announcements as it 
would imply working with Member States: 
 - "to protect citizens from cross border health threats," as described unde r policy objective 4 and 
also by implementing the future legislation on Health Security; 
 - "to increase the sustainability of health serv ices", as described within policy objective 1 and 
also, indirectly, under policy object ive 3 with prevention aspects; 
  - "to improve the health of  the population "as described u nder policy objectives 2 and 3 and 
also by implementing EU health related legislation; 
 -  "whilst encouraging innovation in health" as described under objective 1 with HTA and e-
health and also by implementing the legislatio n on medical devices, on medicinal products, on 
substances of human origin. 
6.4.1.2. Contribution to the EU 2020 strategy 
This option would allow the Commissi on to contribute to these objectives: 
• Smart growth - by supporting the implementation of innovative solutions  and techniques in 
the area of health; 
• Sustainable growth - by contributing to find su stainable solutions for healthcare systems, 
including prevention; 
• Inclusive growth - by working on the h ealth workforce shortage problem . 
6.4.1.3. Improvement of the design and monitori ng of the Programme as recommended in 
the evaluations 
Under this option, the new Programme proposed would address the main criticisms made by the 
external evaluations and in the Court of Auditors report. It would have: 
• An intervention logic for its actions; 
• SMART, realistic objectives; 
 48• Prioritised  actions;  
• A set of indicators for measuring the outcomes and the impact. 
Thus, it would be possible to measure achievements,  to adjust priorities, indicators, to act if 
achievements are not in line with the milestones es tablished and to determine the impact of the 
programme. 
6.4.1.4. Achievement of objectives , thus of the programme 
Objective1 (example: HTA) 
At Programme's level, it is expected to have the highest number of Member States (through their 
policy makers, health professionals , health institutions) using th e developed tools, mechanisms 
and advices 
At policy level, these items will  support Member States, policy ma kers, health professionals, 
health institutions in reaching an  adequate supply of health prof essionals in MS, reaching a cost-
effective use of medical te chnologies and improving d ecision-making, organisational 
management and performance of the health systems. 
For instance, with HTA, the projects funded un til now have supported the establishment of a 
European HTA network, the development of co mmon methodological basis for assessing health 
technologies (so called "core HTA model"), th e testing of this co re model on selected 
methodologies (medicine and screening devices)  and the development of tools supporting and 
enlarging EU cooperation. This will be continued in the coming years to ga in better insight on 
the feasibility of cooperation models, to establis h scientific guidelines fo r users (health related 
industries) and to organise trainings in MS for stakeholders on the use of the core HTA model. 
The availability of core model should help reduce the duplication of work and result in 
economies of scale. The standardis ation, at EU level, of data a nd information requirements from 
industry should have positive effects on tran sparency and quality of decision making  
Objective 2 (example: reference networks for rare diseases) 
At Programme's level, it is expected to have the highest number of health professionals using the 
expertise gathered through the European Refe rence Networks put in place and functioning, and 
to have the highest number of Member States (through their policy makers, health professionals, 
health institutions) using the deve loped guidelines on patient safety.  
At policy level, these items will support MS in  improving access to diagnosis and provision for 
all patients requiring highly special ised care for a specific disease or group of diseases and to 
support MS reducing morbidity and mortality re lated to healthcare qua lity and increasing 
patients/citizens confidence in  the health care system. 
For instance, the pilot European reference Networks (ERNs) in th e area of Rare Diseases (RD), 
aims at  supporting the policies and initiatives of MS  in the following areas: recognition of RD, 
research, development of national plans and st rategies, knowledge production and dissemination, 
empowerment of patient organizations; set up of pilot European Reference Networks.  
Analysis of networks previous ly and currently funde d show that the most valuable outcomes 
developed by the pilot networks are: 
• Shared databases/ registries; 
• Shared tools for expertise in diagnosis and treatment, including tele-expertise; 
• Guidelines for clinical care and for biological  diagnosis and disease-specific information; 
• Training tools and sessions, both for h ealthcare professionals and patients; 
Taking into account that knowledge and resources in the area of Rare Diseases are extremely 
scarce, the mere collection of information and existence of shared t ools for exchange of 
 49knowledge  and expertise , are more  than simple  outputs . They  effectively  represent  an increase  in 
access to available information both for healthcare professionals and other experts and patients and their families that should lead to improved quality of care and improved quality of life for 
patients.  
But in order to ensure a long lasting impact and the expansion to new members, the update of 
information/knowledge and the maintenance and furt her development of tools put in place in the 
initial phases have to be continued.   
Objective 3 (example: cancer) 
At Programme's level, it is expected to have the highest number of Member States, through their 
policy makers, health professionals , health institutions and stake holders from bodies involved in 
good health and prevention of diseases, using the va lidated best practices in order to, at policy 
level, support Member States in their e fforts to reduce risk factors for diseases. 
For instance, under the previous current Health Programme, the ai m of the projects funded under 
the action for cancer is to contribute to the reduction of cancer's burden in the EU by:  
(i). providing a framework for identifying and sharing information, capacity and expertise in 
cancer prevention and control,  
(ii). involving relevant stakeholders across the EU in a collective effort. 
As of today, the main results are:  
• screening guidelines for colo rectal and breast cancer;  
• the support of EU-wide promotion/prevention ac tivities: European week  against cancer, EU 
code against cancer, AURORA project for scre ening of cervical can cer, EPIDERM project 
for skin cancers, conferences such as Europa  Donna Breast cancer, ECPC cancer summit, 
etc; 
• the support of a cancer network; 
• the standardisation of data in relation with  the European Community Health Indicators 
system; 
• the support of the European Ne twork of Cancer Registries 
It is difficult to differentiate the impact of EU  funded actions from MS action. The impact of the 
first programmes against cancer (1985-2000) has been evaluated via a study comparing the 
actual rate of mortality
 reduction (10%) to the pre-defined rate (15%). But the difficulty lies in 
identifying the exact role of the programme in  this decrease. It is almost impossible to 
differentiate action at EU level and action at MS  level. Which also demonstrates the need for 
indicators at the right level of incidence of the programme (see also point 6.4.3 and point 7.1). 
Objective 4 (example: health threats) 
At Programme's level, it is expected to have the highest number of Member States, through their 
policy makers, health professionals, health in stitutions, integrating the developed common 
approaches in the design of their preparedness plans. 
At policy level, the uptake of the outcomes of  these actions will support MS putting in place a 
strong set of coordinated public he alth measures at EU level to he lp minimise the public health 
consequences of cross-border health threats (whi ch could range from mass contamination caused 
by chemical incidents to epidemics or pandemics). 
Leverage for Member States' he alth policies: In this option, support would be given to the 
Member States, in the form of cooperation, sh aring knowledge, etc in areas falling under the 
specific objectives. Thus probably the degree of im portance to do things in these areas could be 
increased in MS which would, in turn, take th em into consideration in their own policies. 
 50For instance , to support  the acquisition  by Member  States  of the core capacities  for the 
implementation of the Internat ional Health Regulation, the Health Programme has funded 
several actions (SHIPSAN, SHIPSAN II, REACT, Episouth, Episouth+) to develop a framework 
to identify and exchange good practice in al l preparedness activi ties, including their 
transferability and procedures for travel related contact trac ing. The following outcomes were 
obtained: 
• a European Manual for hygiene standards and Communicable Disease surveillance on 
passenger ships (SHIPSAN project); 
• training tools and models addressing generic preparedness and response for the international 
spread of infectious disease at Eu ropean level (REACT project );  
• reports and concept for future collaboration in  Cross-border epidemic intelligence, Vaccine 
preventable diseases and migran ts, Cross-border emerging zoonos es and Training in applied 
epidemiology, and developing the Mediterra nean network (Episouth project);  
• establishment of the Mediterranean regional laboratories network, development of generic 
preparedness plan and risk management procedures (EpiSouth+; currently ongoing). 
The impact from SHIPSAN projects will be the most visible as the application of common 
standards in hygiene inspections are expected to  have a significant contribution to the reduction 
of food borne and waterborne dis eases in ships, as already dem onstrated by US Vessel Sanitation 
Programme (VST). Additionally, experience acqui red with SHIPSAN will be useful for the 
development of the cargo ships manual and inspection programme.  
For other actions, the networking an d exchange of experience could lead to the strengthening of 
core capacities and the development of a coordina ted public health culture of risk assessment and 
risk management of hazards events. 
6.4.1.5. Implementation of Commission's legal obligations and synergies between the 
actions undertaken for the implementation of legislation and actions undertaken in order 
to achieve different objectives  
These obligations would be fully fulfilled and synergies could be developed with actions 
undertaken in view of achieving the objectives of the programme.   
6.4.1.6. Impact of simplification measures 
On one hand side, the multi-annual programming of the implementation of the programme as 
well as the reduction of the number of actions and also the increase of the size of the projects 
will contribute to limit the burden related to the management of the programme. This means that 
the overall increase of allocation, in comparison to  the current programme, will not be applied to 
the administrative costs.  
Other simplification measures are directed both at  beneficiaries and also  at reducing the burden 
related to the management of the programme (electronic submission of projects proposals, 
simplification of the evaluation criteria, etc.). 
Thanks to these simplifications, it will be possible  that administrative costs remain at the same 
level as in the current programme.  
6.4.1.7. Compatibility with the available resources 
This option would be compatible with the availabl e resources as the amount of allocations would 
be the same as the amount in the MFF communication. 
6.4.5. Option 3, sub-option B  
This option corresponds to a well structured pr ogramme dealing only with the same set of 
objectives and horizontal activities but, as a trad e off, action on promoting health would not be 
 51carried  out. Promotion  of health  is not retained  as it is an area, according  to evaluations , where  
impact is very difficult to measure and wher e it can only be measured on the long term.  
The repartition of credits per policy objectives an d in comparison with sub-option 3a would be as 
follows: 
 Average per year  
Policy objectives 2014 – 2020 
(sub-option 3A)  2014 – 2020 
(sub-option 3 B)  difference 
1) develop common tools and 
mechanisms at EU level to address shortages of resources, both human and financial, and facilitate up-take of innovation in healthcare in order to contribute to innovate and sustainable health system  24.3 24.3 0 
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 citizen  11.3 11.3 0 
3) identify, disseminate and promote 
the up-take of validated best practices for cost-effective prevention measures, in particular 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  10.9 5.9 -5 
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 treats  4.6 4.6 0 
TOTAL 51.1 46.1 -5 
    
    
The total budget for the option 3 B would be EUR 43,9 million. 
 52Under  this sub-option , the impact  of the programme  would  be comparable  to that of sub-option  
3a with the following exceptions. 
6.4.5.1. Consistency with the announcements of the MFF communication  
Under this option, the programme's objectives woul d be mostly aligned to these announcements 
but with a reduced contribution "to improve the h ealth of the population" and also "to increase 
the sustainability of health se rvices" as there would be no prom otion of good health and health 
determinants anymore. 
6.4.5.2. Contribution to the EU 2020 strategy  
This option would also allow th e Commission to contribute to these objectives but to a lesser 
extent than option 3 A as the objective on promo tion of good health would not contribute to 
sustainable growth anymore. 
6.4.5.3. Improvement of the design and monitori ng of the Programme as recommended in 
the evaluations 
As in option 3 A. 
6.4.5.4. Achievement of objectives , thus of the programme 
Objective 3 would be reduced to actions on cance r and chronic diseases which would mean that 
promotion of good health would remain at the sole level of the Member States. Thus the Programme would not be a source of inspiration or/and example for their own national polices. 
In the same time, prevention and promotion of good health are two of th e areas that are very 
much demanded by Member States when they are c onsulted. This is also  area of high importance 
for various NGOs. 
Finally, prevention is probably one of the cheapest ways to ensure  the sustainability of health 
systems, assuming that it prevents people fr om becoming ill. Commission thus ought to 
participate, generate, support work  in this are as it also serv es the first objective of this 
programme, even if indirectly. 
6.4.5.5. Implementation of Commission's legal obligations and synergies between the 
actions undertaken for the implementation of legislation and actions undertaken in order 
to achieve different objectives 
These obligations would be fully fulfilled and synergies could be developed with actions 
undertaken in view of achieving the objectives of the programme.   
6.4.5.6. Impact of simplification measures 
As in 3 A. 
6.4.5.7 Compatibility with the available resources 
This option would be compatible with the availabl e resources as the amount of allocations would 
be lower as the amount in the MFF communication. 
6.4.6. Option 3, sub-option C
 
This option corresponds to a programme limited to: 
- the financing of Commission’s obligations for implementing the current health legislation, the 
tobacco directives, and the legislation on medicinal products and medical devices; 
- the development common approach es and demonstrate their value for better preparedness and 
coordination in health emergencies in order to pr otect citizens from cross-border health threats. 
 53In addition , there  would  be some  dissemination  of the results  of the current  Health  Programme  
(2008–2013) in order to take into account th e conclusions of previous evaluations. 
Protecting citizens from cross-bord er health threats would be reta ined for funding first because it 
is stipulated under the article 168 of the Treat y. Furthermore, the EU added value of this 
objective is clearly established, mainly in relati on to the cross border cr iteria, as well as its 
legitimacy: it is considered of crucial importance to have well prepared Member States and an adequate EU coordination in order to be able to  face such events. And by definition,   Member 
States cannot act efficiently alone on this. 
The repartition of credits per objectives co mmand comparison with Option 3 A would be as 
follows: 
 Average per year  
Policy objectives 2014 – 2020 
(sub-option 
3A) 2014 – 2020 
(sub-option 3 C)difference 
1) develop common tools and mechanisms at EU level to address shortages of resources, both human 
and financial, and facilitate up-take 
of innovation in healthcare in order to contribute to innovate and sustainable health system  24.3 10.2 14.1 
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 citizen  11.3 4.5 6.8 
3) identify, disseminate and 
promote the up-take of validated best practices for cost-effective prevention measures, in particular 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  10.9 0.5 -10.4 
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 treats  4.6 2 -2.6 
 54Total 51.1 17.2 -33.9 
    
    
The total budget for the option 3 C would be EUR 24.4 million 
6.4.6.1. Consistency with the announcements of the MFF communication  
Under this option actions undert aken would be reduced to th e protection from cross border 
health threats and nearly nothing else. 
6.4.6.2. Contribution to the EU 2020 strategy  
Under this option, the programme would not be contributing to: 
- the smart growth objective, as it would not be supporting th e implementation of innovative 
solutions and techniques in the area of health; 
 - the sustainable growth objective by not suppor ting MS in finding sustainable solutions for 
healthcare systems, including prevention; 
 - the inclusive growth object ive by not working on the health workforce shortage problem. 
6.4.6.3. Improvement of the design and monitori ng of the Programme as recommended in 
the evaluations 
Under this option, the design of the programme w ould be very much limited as there would only 
be one objective left. However, prioritisation of actions and use of indicators under this objective 
would still be necessary. 
6.4.6.4. Achievement of specific obj ectives, thus of the programme  
In this option, none of the objectives would be achieved except for specific objective 4. In 
addition, this option would result in  a loss of the investments made in previous programmes. It 
could even imply a regression in areas where MS ca nnot tackle issues alone (see rare diseases in 
option 1). 
In addition, most of the concerns of the Memb er States would not be taken into account. 
Finally, the leverage on member States policies would be limited to the protection of citizens 
from cross border health threats an nothing else. 
6.4.6.5. Implementation of Commission's legal obligations and synergies between the 
actions undertaken for the implementation of legislation and actions undertaken in order 
to achieve different objectives 
These obligations would be fully fulfilled but syne rgies could only be developed with the Health 
Security legislation (assu ming that it is adopted).   
6.4.6.6. Impact of simplification measures 
The implementation of the simplification measures would be of a limited magnitude as these 
measures are mainly about the implementation of  actions outside implementation of legislation 
and under this option there are only actions unde r the protection of citizens from cross border 
health threats. This would of course not preven t the limitation of projects to be funded and their 
size. 
6.4.6.7. Compatibility with the available resources 
 55This option  would  be compatible  with the available  resources  as the amount  of allocations  would  
be significantly lower as the amount foreseen in the MFF communication.  
6.5. Option 4  
This option corresponds to a well-structured prog ramme focusing on the same issues as option 3 
b) but adding a specific objective for addressing wider, social and econom ic, causes of health 
inequalities by appropriate means within the prev ention of disease general objective. This option 
would imply a significant increase of the envelope for the programme. 
This would entail giving suppor t to action taken by Member Stat es - with a focus on countries 
and regions where health stat us and health inequalities ar e particularly negative - on: 
• implementing and evaluating evidence-based plan s to address inequalities by means of public 
health action, across the health system and in  coordination across relevant policy fields; 
• developing innovative appro aches, by providing funding for specific pilot cooperation 
projects between Member States and stakeh olders to develop jo int work to reduce 
inequalities. This could include specific measures such as adapting health services to improve access; targeting services and improving the quality of the services offered; linking 
health, social and employment services; de veloping and implementing targeted health 
promotion measures; or helping with measures in other policy areas, for example to improve 
access to high-quality food or better housing; 
• addressing the specific needs of vulnerable gr oups by taking forward coordinated action on 
specific priority work which would contribute to  addressing inequalities, such as access to 
ARV treatment and prevention, good practice on migrant health or similar areas where EU 
support can help build added value. 
Work would complement national policies to improve public healt h, prevent physical and mental 
illness and obviate sources of danger to physical and mental health. This would also cover 
support for a validation mechanism and for coopera tion between Member St ates to coordinate 
their policies and programmes on public health. This would include organising exchanges of 
good practice, drafting and estab lishing guidelines and indicators  and monitoring and evaluation 
activities. 
It would also include stronger mechanisms to e ngage other relevant Eu ropean players in the 
health sector, including regions and stakeholders , and cooperation with the relevant international 
organisations responsible for public health. 
Given the challenges identified in the Com mission Communication on health inequalities 
(COM(2009) 567), the Communication on Eur ope 2020 (COM(2010) 2020), the European 
Parliament resolution of 8 March 2011 on reducing health inequali ties in the EU and the Council 
conclusions of June 2010 on equity and health in all policies, this option would require a 
considerable increase in inve stment from current levels. 
Under this sub-option, the impact of the programme would be comparable to that of sub-option 
3a with a developed action on health inequaliti es. However, this option would imply a much 
higher amount in funding than even sub-option 3a and thus is would not be  consistent with the 
amount foreseen in the MFF communication. 
6.6.  Comparison and assessment of the options
 
Option 1: 
This option corresponds to maintaining the mi nimum level of interv ention imposed by the 
legislation and discontinuing all other actions at EU level. This would cause a reduction of EU 
support to Public Health policy, as well as contravene the conclu sions of the evaluation of the 
current Health programme and the requests for a continuation of the programme made by the EU 
 56Health  ministers  and other  stakeholders . It would  fail to guarantee  an adequate  support  to the 
future Public Health policy. 
Option 2: 
Under this option, Member States and stakeholders ' concerns would indeed be taken into account 
to a certain degree and it would have leverage on national health polic ies. However, in the 
absence of intervention logic, l ack of SMART, focused and real istic objectives, with a large 
number of actions not prioritise d and no indicators to measure the achievements or indicators 
geared towards an hypothetic im pact on citizens, which a prog ramme supporting policies cannot 
have, any kind of impact would first be very diffi cult to measure and then very limited, because 
not part of a logic. This type of programme w ould not allow to achieve the objectives defined in 
this impact assessment and it would not take into account the recommendations stemming from 
the past evaluations and audits. 
Option 3 A: 
Under this option, the specific objectives would be achieved th rough 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 re port. It would have an interven tion logic, well  defined policy 
objectives, SMART, realistic, outcome oriented a nd pragmatic specific objectives, actions to be 
carried out would be prioritised and a set of indicators would be defi ned for measuring the 
outcomes and the impact. 
Thus, it would be possible to measure achievements and to act if they are not in line with 
milestones established and finally to de termine the impact of the programme. 
Option 3 B: 
This option corresponds to a lower budget than  the current programme and the allocation 
foreseen in the MFF. This option would not allo w addressing satisfactorily the challenges faced 
in public health as the synerg ies between promotion of good hea lth and chronic diseases would 
be lost, especially regarding citizens' exposure to chronic di seases. The programme would not 
respond to the expectations of Memb er States and other stakeholders. 
Option 3 C: 
This option corresponds merely to option 1 but w ith the specific objectiv e 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 contin uation of the programme 
made by the stakeholders and the MS. It would fail to guarantee an ad equate support to the 
future Public Health policy  currently under preparation. 
3 out of 4 of the specific objec tives defined in this impact assessment would not be achieved. 
Such a programme would not respond to the e xpectations of Member States and other 
stakeholders. 
Option 4: 
This option corresponds to a substa ntial increase of the Public Health budget which is simply not 
realistic. 
 
RESULT: Option 3a is thus, by far, the preferred one  
 
 57This can be summarised  in the table  below:  
 Options 
Regarding achievement of the objectives of the Programme 
Impact/output  1 2 3a 3b 3c 4 
a) Consistency with the 
announcements of the MFF communication:  0 + +++ ++ + +++ 
b) Contribution to the EU 2020 
strategy + ++ +++ ++ + ++++ 
c) Improvement of the design 
and monitoring of the Programme as recommended in the evaluations:  + + +++ +++ ++ +++ 
d) Achievement of objectives, 
thus of the programme: 0 + +++ ++ + +++ 
e) Implementation of 
Commission's legal obligations 
and Synergies between the 
actions undertaken for the implementation of legislation and actions undertaken in order to achieve the different specific objectives:  ++ + +++ +++ ++ +++ 
f) Impact of simplification 
measures:  + + +++ +++ ++ +++ 
g) Compatibility with the 
available resources +++ +++ +++ +++ +++ 0 
 
 
 
+++ Satisfactory  
++ Limited  
+ No  
7. M ONITORING 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. 
7.1. Multi-annual programming  
The proposal is to set up an i ndicative internal multi -annual work programme before the start of 
the Programme. It would be based on the priorities and deadlines, whether already existing or yet 
to be defined, which the Co mmission would set itself.  
It would serve as a guideline for the annual work pl ans. It would, of course, be flexible enough to 
allow readjustment of health topics under each specific objective. For instance, between now and 
the beginning of 2014, new topics may appear and will have to be taken into account in the 
Programme. Similarly, the structure proposed for th e Programme also allows some flexibility at 
 58the level  of action  without  risking  losing  the focus . Still, for any re-prioritisation , the criteria  for 
creating EU added value identified in Section 4.3. would have to be followed. 
This will make it possible to  limit the annual prior ity areas and increase the amounts of funding 
available for those priorities and specific acti ons for a given year. This will rationalise the 
preparation of the annual work pl ans and with fewer projects - th e monitoring. It will also allow 
for more time to follow up results for policy work, di ssemination, etc.  It will, last but not least, 
finally facilitate coordination of the Progr amme with other progr ammes and Commission 
departments, including the work plans of the European Centre for Disease Prevention and 
Control (ECDC), the European Medicines Agency  (EMA), the Executive Agency for Health and 
Consumers (EAHC) and other agencies. 
7.2. The financial mechanisms  
A wide range of financial mechanisms will be us ed in the Programme: cal ls for proposals, grants 
for actions with Member States, grants for in ternational 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 H ealth Programme. In addition, each financing 
mechanism seems to contribute positively to achi eving the aims of the Health Programme. For 
example: 
• Projects involve regional governments and NGOs; 
• Grants for actions  with Member States involve them more closely, suggesting that the 
results might be used better at national level given the direct involveme nt of Member States; 
• Operating grants guarantee the funding of an organisatio n for a short period (one to two 
years). However, once this funding comes to an end, the sustainability of the organisation is 
challenged; 
• Grants for international organisations , where appropriate without previous call for 
proposals; 
• Tenders can be used for specific ai ms, but their specifications n eed to be well defined in 
order to achieve the desired results. 
Clear guidelines will continue to be provided to potential particip ants so that they can decide 
which financing mechanism would be most appropr iate for their proposal. Such guidelines were 
first provided for call for proposals 2007. According to the mid-term evalua tion, this has led to a 
more straightforward process for those applying for funding. 
7.3.  Simplification  
The design of the new Programme  implies the simplification of  the implementation and 
management of the Programme:  
1. The level of Union's co-finan cing for grants for actions, acti ons co-financed by the competent 
authorities of the Member States or the thir d countries, or by non-governmental bodies mandated 
by these authorities and for operating grants will be  harmonized at 60% of eligible costs and up 
to 80% in cases of exceptional utility. 
2. The new possibility to amend the upper li mit of co-financing th rough Delegated Acts 
procedure will bring more flexibi lity than under the current Programme .  
3. The long-term programming of strategic acti ons of the Programme will help reduce their 
overall number per year and avoid repetitive work in application, evaluation, negotiation and 
contracting procedures. In additi on, this will enable greater focu s on the priority areas and better 
use of human and financial resources. The fundi ng process will be simp lified in particular 
through the use of framework contra cts for operating grants and the possibility to use lump sums 
whenever possible will be examined so as to reduce the administrative burden.  
 595. The management  by the Executive  Agency  for Health  and Consumers  also contributes  to the 
streamlining of procedures in the management of the Programme: an electronic submission 
procedure shall be introduced, which would deliver  savings for applicants as well as for the 
Commission. From a legal point of view, electronic submission is less prone to contestation, e.g. 
about loss of documents. However, given the lim ited number of submission s per year in response 
to the call for proposals for the Health Programme  (for example, 113 in 2 011), any such solution 
would have to be generally applied to other programmes managed by the Executive Agency to 
make it more cost-effective. 
Regarding the selection procedure , the mid-term evaluation of the current Programme 
concluded that the selection pro cess for that Programme is str ong at ensuring that appropriate 
and competent applicants are se lected for funding. The action funde d to date seems to address 
issues reflecting public health  concerns in the European  Union and internationally. 
The evaluation process makes use of external peer reviews . The objective of peer reviews is to 
ensure the independence of th e evaluation, guarantee the cred ibility of the organisation 
performing the evaluation and offer the benefici aries advice/recommendati ons from scientific 
experts. The involvement of external evaluators also guarantees a fair process and equal access. 
Thus, the current selection process is an impr ovement compared with the previous Health 
Programme and will be continued. 
Three sets of criteria are considered, one after th e other, during the evaluation procedure in order 
to select proposals for funding: 
• The exclusion  and eligibility criteria , which all proposals must comply with, confirm that 
the applicant is eligible and the proposal complete; 
• The selection criteria  relate to the financial and opera tional capacity stipulated in the 
proposal; and 
• The award criteria  include the quality of the action pr oposed, taking into account its costs. 
They include the following three factors: rele vance to EU policies (block A), technical 
quality of the project (block B) and management quality (block C). 
Proposals that fail to meet the requirements of any one of these categories are rejected. However, 
the assessment is normally performed in full against all three blocks  of award criteria. 
Consideration could be given to not proceeding further if some proposals have already been rejected in previous  steps (e.g. block A). 
7.4. Indicators
 
It is important to remind here that Health fo r Growth Programme is an EU spending Programme 
to support health policy. It is thus not possible for the Progra mme to have impacts other than the 
effective dissemination of its results and the acce ptance of its outcomes by MS so that the results 
obtained can be put into practice.  
In designing the programme, end-us ers have been clearly defined as well as the reason for which 
they are can cooperate in the Programme.  These are health policy makers and public health 
practitioners committed to improve quality and sustainability of health systems and take preventive health measures to improve the health  of the population. This means that indicators 
can only be defined at Member St ate or stakeholders' level.  Th e Programme has no objective on 
individual citizens and cannot act di rectly at their level, which re mains in Member States’ remit. 
This also implies that a significant proportion of the activities of the Programme will, as in the 
past, take the form of productio n and dissemination of validate d knowledge and evidence in the 
field of public health for health policy makers a nd health practitioners. This aspect permeates all 
the specific objectives of the proposed Programme and is in line both with the context of the 
Programme, as presented in earlier sections, and with the expecta tions of the Member States.  
Thus, output indicators can only measure the production of these best practices, tools, 
mechanisms, guidelines, that have been develope d. And impact indicators can only be about the 
 60uptake  of these  best practices , mechanisms , guidelines  by the end users . Thus , the success  of the 
Programme can only be defined in terms of the rate of implementation, participation by Member 
States and take-up of the outcome in the differe nt Member States and st akeholder groups, on top 
of the actual results achieved comp ared with predefined levels. 
In its letter of 29 June to  the Commission, the Standing committee of European Doctors43 also 
recommends this approach: 
"Implementation of actions and uptake of Progra mme results are key for the success of the 
programme and it could represent a good indicator. Hence, the indicator could be defined in 
terms of the rate of the im plementation and uptake of progra mme outcomes in the different 
Member States and stakeholder groups as well as the actual rate of predefined results achieved. In addition the visibility and uptak e of outcomes of indi vidual actions beyond the actors directly 
involved are a valuable measur ement tool. In order for this to be achieved, however, the 
communication and evaluation mechanisms within indi vidual actions must be reviewed, so as to 
allow for meaningful impact assessments. " 
A complete set of indicators is described below: 
• there are indicators to measure the achievem ent of the objectives: outcome indicators and 
impact indicators for each of the specific objectives; 
• there are indicators addressing issues highli ghted in the evaluations: on the level of 
participation of Member States, on communication and dissemination,  
• and there are indicators at the level of projects funded: regard ing the adequateness of the 
actions that are proposed for financing which can give an indication about the level of 
interest of stakeholders on this action; the outcomes of the projects (also intermediate); the quality of the projects. 
7
.4.1. At the level of the specific objectives of the Programme 
As a consequence of the above, for each of the specific objectives, a double set of indicators will 
be put in place: one outcome indicator and one im pact indicator. The outcome indicator provides 
a means to measure the result of the action taken and the impact indicator to measure the take-up 
of the outcome by the Member States or stakeholders.  
The table below gives examples of outcome and impact indicators for th e specific objectives of 
the Programme. These are not yet finalised, in te rms of either numbers or years, and could 
change, as more work still needs to be done to identify the best indicators. They will also be 
reviewed in the course of the Programme to see if they need to be revised. 
 
Outcome indicators  Impact indicators  
Specific objective 1: develop common tools and mechanisms at EU level to address 
shortages of resources, both human and financia l, and facilitate up-ta ke of innovation in 
healthcare in order to contribute to innovate and sustainable health system  
Number of tools and mechanisms developed 
by 20XX, 20YY and 20ZZ Number of Member States/stakeholders using 
them by 20XX, 20YY and 20ZZ 
Specific objective 2: increase access to me dical expertise (European reference networks) 
and information for specific areas and beyond national borders, and develop shared solutions and guidelines to improve health care quality and patient safety in order to 
increase access to better and sa fer healthcare for EU citizens  
Number of functioning ERNs  by 20XX, Number of health care specialists using this 
                                                 
43 CTME Comité permanent des médecins Europeéns, letter to Commission 29/6.  
 6120YY  and 20ZZ  expertise  by 20XX , 20YY  and 20ZZ  
Number of guidelines developed by 20XX, 
20YY and 20ZZ Number of Member States/stakeholders using 
them by 20XX, 20YY and 20ZZ 
Specific objective 3: identify, disseminate and promote the up-take of validated best 
practices for cost-effective prevention measu res, in particular by addressing the key 
risk factors, namely smoking, abuse of alco hol and obesity, as well as HIV/AIDs, with a 
focus on the cross border dimension, in or der to prevent diseases and promote good 
health  
Number of validated be st practices developed 
by 20XX, 20YY and 20ZZ Number of Member States/stakeholders using 
them by 20XX, 20YY and 20ZZ 
Specific objective 5: develop common appr oaches and demonstrate their value for 
better preparedness and coordinati on in health emergencies in  order to protect citizens 
from cross-border health treats  
Number of common approaches developed 
by 20XX, 20YY and 20ZZ Number of Member States/stakeholders using 
them by 20XX, 20YY and 20ZZ 
Measurement of Impact indicators 
In short, the impact indicators fo r the specific objectives can be su mmarised as the rate of use, by 
Member States and/or stakehol ders, of the tools developed. 
To identify and measure the impact of the Progr amme, it is absolutely n ecessary to know if, and 
for which reasons, the outcome of the Programme is  used in Member States and if not why not, 
because this is also a sign that the specific obje ctives/action are failing to meet Member States’ 
needs. 
It is therefore suggested that the National Fo cal Points (NFP) Network, an informal network 
already providing support to the current Programme, should be established formally with a clear 
mandate under the legal base adopted for the Programme. 
Impact indicators will have to be defined a nd evaluation mechanisms put in place in close 
collaboration with the NFPs (systematic feedback  from questionnaires to  stakeholders, revision 
of evaluation methods within th e action funded, allowing meaningful  impact assessment, etc.). 
The success of the Programme could be defined in terms of the rate of implementation, 
participation by Member States and take-up of th e outcomes in the different Member States and 
by stakeholder groups, on top of the actual result s achieved compared with predefined levels. 
7.4.2. Other indicators 
a) Rate of implementation 
In accordance with the objectives of the Pr ogramme, as described above, and with the 
imperatives of the Europe 2020 Strate gy, the proposed i ndicator is that: 
• at least 40  % of the total budget for the Health Pr ogramme (on average for the period 2014–
2020) be allocated to action s upporting the safety, quality a nd efficient use of medical 
technologies (pharmaceuticals, vaccines, medi cal devices, HTA, genomics, etc.). This 
indicator would be reviewed and, if nece ssary, revised after th ree years following an 
evaluation of achievements and assessment of needs. 
b) Participation by Member States 
As regards satisfactory participation by Memb er States, the proposed indicator could be: 
• 50 % increase in participation by Member States with a very low participation rate or which 
were declared inactive in the previous Programmes. 
 62This indicator  is very important  because  it reflects  the relevance  of the objectives  of the 
Programme to Member States’ ne eds and its inclusive dimension. Inactive Member States will 
only be motivated to participate in the Progra mme if its objectives reflect their concerns. 
This certainly implies that administrative, financ ial and language barriers have to be removed. 
Especially, for Member States with low GNI, the EU contribution should cover at least 80  % of 
the total expenditure on the action taken or some other cost mode l for EU co-financing should be 
activated. 
c) Communication and dissemination indicators 
To make it easier for Member States and stakehol ders to take up outcomes and, thus, to make an 
impact, good communication and systematic dissemina tion of results are crucial. They make the 
outcomes visible. In this area, there is room for improvement, as highlighted in audits and 
evaluations of the two previous Progra mmes, for 2003-2007 and 2008-2013. Dissemination and 
good communication should therefore also be monitored, based on the following indicators (to 
be finalised): 
• number of articles published in  peer-reviewed scientific and/ or specialist journals on the 
results of action financed under the Programme; 
• amount of information related to the output of the Programme available on the web; 
• thematic conferences organised to present work  in progress (at least one every two years); 
• documented systematic promotion of key outcomes of the Programme to policymakers and 
other stakeholders. 
d) Adequateness indicator 
Immediately before any action starts, its adequa teness can be measured. In particular, if, in 
response to a call for proposals, no proposals are made  for some areas, this has to be analysed to 
identify the reason for this failure, for example: 
• the action was not described cl early and potential benefici aries did not know what was 
expected; 
• the action is too ambitious in comparis on with the indicative amount allocated; 
• the action is not interesting for potential beneficiaries. 
e) Outcome indicators 
At the end of each action, systematic monito ring of outcomes under ea ch of the specific 
objectives is required. The actual ra te of achievement of the pred efined results for each action 
linked to a specific objective could serve to ju stify continuation of th e objective and of the 
Programme. 
For instance, under specific objective 1 ‘Develop  common tools and mechanisms at EU level to 
address shortages of resources, both human and financial’, the following outcome indicators 
could be used for the action addres sing health workforce shortages: 
• By 2015, creation of an EU platform enabling Memb er States to work together on forecasting 
health workforce needs, workforce planning methods and mobility trends (with at least 18 Member States participating). By 2020, an operational platform covering all EU Member 
States. 
• By 2014, EU guidelines on how to implement the WHO Code of Practice on the international 
recruitment of health personnel. 
• By 2015, bilateral agreements on training for health professionals in place. 
• By 2015, routine forecasting of needs for health professionals at EU level. 
 63f) Quality  indicators  
In addition, quality indicators should be applied systematically to all projects financed under the 
Programme: 
• 100  % of projects should comply with  the EU added value criteria; 
• 100  % of projects should be ev aluated by internal bodies; 
• All long-term projects must be evaluated at ap propriate interval in order to determine if 
continuation of the funding is justified. 
7.5. Evaluations  
The Programme will be subject to mid-term term and ex-post evaluation.  
A mid-term evaluation will aim at measuri ng progress made in meeting the Programme 
objectives, determining whether its resources ha ve been used efficiently and assessing its 
European added value. The mid-term evaluation w ill include a review of the indicators in order 
to assess their relevance and revise them if n eed be or if priorities have changed since the 
beginning of the Programme. Impact indicators will still be difficult to re view as, at mid-term, 
there will not yet be many outcomes (not many projects will have been finished by then) and thus not much chance of taking up the outcome. The mid-term evaluation will serve the impact assessment exercise for eventual follow-up programme in the area of health post-2020. 
Ad-hoc  evaluations will also be cond ucted, to a lesser extent, for sp ecific projects or action as a 
whole, whenever necessary. 
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 and for the design of the future programme. 
 64 
ANNEX  1: DG S IN THE  STEERING  GROUP 
 
BUDG 
CLIMA COMM COMP DEVCO EAHC ECFIN EEAS EMPL ENER ENTR ENV ESTAT HR INFSO JRC-ISPRA JUST MARKT REGIO RTD SG 
 
 
   
 
 65ANNEX  2 - TIMETABLE  
Month Ex post finale 
evaluation 
of the PHP 2003-2007 Mid-term evaluation 
of the Health Programme 
2008-2013 and health 
Strategy Health Programme 
Post 2013 - Consultation  
Avec les stakeholders 
JAN Reception of the final 
report Inception report  Concept paper and the draft Road Map IA 21/01 - National Focal Points 
meeting  (tour de table 
FEB   24/02 - Roadmap submitted to SPG meeting and 
approved. 
 17/02 - Programme Committee 
meeting 17/02 
MARCH Approval of final report Interim report Dr afting of composite Impact Assessment for sec Gen 
15/03 - Roadmap sent to Sec Gen  
31/03 – Composite IA sent to Sec Gen 18/03 - Meeting of the Senior 
Working level Group on Health  
APRIL   Start the Impact Assessment  
15/04 - 1st meeting with the IA Steering Group (ISG on 
Health) 
 4-5/04 - Informal EPSCO (Health) 
Council in Gödöllö 
MAY  10/5 - amended interim report Drafting 19/05 - Health Policy forum 19/05 
JUNE  30/6 - Draft final report 10/06 - 2nd meeting of IA Steering group 30/06 – contribution from special 
working group from the Health Forum 
JULY  25/07 - Final report 18/07 – 3rd steering group 
Finalisation of impact assessment.  
AUGUST   24/08 – at the latest, submission to IAB  
SEPT   21/09 – Impact Assessment Board 
Drafting of the new programme.  
OCT  Drafting of a Commission 
staff working paper on this 
evaluation (unless we can add it to the Impact Assessment) Finalisation of draft of the new Health Programme and 
launch of the ISC  
NOV   Transmission of the draft proposal to the College 
Adoption by the College in  a package with other 
financial frameworks (as per Sec Gen's proposal for calendar)  
DEC     
 66ANNEX  3: E X-POST EVALUATION OF THE PUBLIC HEALTH PROGRAMME 2003-2007( CONDUCTED BY 
COWI  S/A)   
 
 
KEY POINTS  
Achievement of programme objectives 
• The case studies illustrate a clear linkage between the objec tives of the PHP and the projects funded on one hand and how 
these projects may contribute to the achievements of the objectives of the PHP on the other hand. However, the assessment of achievement of objectives is hamp ered by lack of clear performance indicators. 
• The e-survey reveals that even though many  stakeholders find that the objectives are unclear, there is a general belief that 
PHP objectives have been achieved to so me extent. Beneficiaries are more optimi stic compared with other stakeholders. 
• The case studies document that th e projects funded by the PHP have delivered a number of concrete results in the form of 
reports, articles, websites and training etc. 
• Most of the projects selected for the case studies have a strong potential to contribute to the preparation, development and 
implementation of EU public health initiatives. However, only limited evidence was found of such contributions at both 
national and EU level.  
• There are projects where dissemination of knowledge generated has been considerable. However, for other projects, the 
dissemination effort has not been targeted to all relevant stakeholders.  
• According to the case studies, sustainability was mainly ach ieved by making projects results available on websites after 
the project period and through follow-up projects funded by DG  SANCO. There seems to be a need for a clearer focus on 
dissemination of project results to policy-makers in order to promote sustainability through implementation of policy 
initiatives. 
• According to the case studies, a three-year  funding period is not always long enough to cover the whole project cycle. 
Furthermore, the present funding model where projects compete to obtain funding may promote good start-ups but entail less focus on dissemination and implementation of the results. 
Implementation of the programme 
• All projects selected for in-depth case studies are perceived to be relevant to the PHP and have provided clear European 
added value - in this way, the projects selected may be rega rded as success stories. The Co mmission staff stated in the 
interview that the focus on European added value should have higher priority    
• The portfolio analysis conducted by COWI shows a good coverage of PHP objectives and work plan priorities. 
• However, many stakeholders involved in the implementation of the PHP hold the view that there are too many priority 
areas in the annual work plans. 
• According to the e-survey, most beneficiar ies are familiar with the EU public h ealth policy in general. They are also 
familiar with the general programme objectives and annual pr iorities of the PHP but to a somewhat lesser extent.  
• Other stakeholders employed by international organisations are in general very familiar with the EU public health policy 
and the way the programme supports this policy.  
 67• It may be somewhat surprising that other stakeholders employ ed in the public administration of the Member States are not 
more familiar with the EU public health policy, general prog ramme objectives and annual priorities of the PHP than the e-
survey results indicated. 
• Small organisations might not have the resources necessary to participate in the programme, especially 
organisations/research institutions from Eastern Europe. 
• According to the e-survey, most benefi ciaries have met barriers to receiving  funding (language, procedures, cultural 
differences, new/old EU membership). From the viewpoint of most other stakeholders, there are indeed barriers to receiving funding. 
The five highest ranked recommendations 
1 DG SANCO should reduce the number of prio rity areas in the annual work plans by allowing a maximum of five priority 
areas in each of the three strands to increa se the impact within the priority areas, bringing them to not more than 15 per 
yearly call. 
1 DG SANCO should in collaboration with EAHC define clear performance indicators (success criteria) at programme level 
in order to facilitate follow- up and evaluation of the achi evements. These success criteria should be based on a thorough 
elaboration of the intervention logic underpinning th e different areas and priorities of the programme. 
2 EAHC should compile brief descriptions of project results, compatible with the existing database, including 
considerations about use potential and policy recommendations if relevant, and disseminate these to Commission staff and 
national stakeholders at the political level, under the caveat th at such procedures do not increase the administrative burden 
for the end user and grant holders unnecessarily. 
3 DG SANCO should ensure that the prior ity areas in the annual work plans are fo cused and based on a thorough analysis 
of needs and European added value. This analysis should be carried out by public health experts versed in these issues. 
4 EAHC and DG SANCO should pursue inclusion of Member St ates which appear inactive in  the programme. These are 
typically countries with a relatively low GDP/capita. Inclusion could be pursued by providing technical assistance to write proposals (EAHC) or by increasing the EC financial contribution (DG SANCO), possibly on the basis of an alternative cost model. 
 68EXECUTIVE SUMMARY  
1.1 Introduction  
The overall purpose of this evaluation is to assess the effectiven ess, efficiency and utility of the Public Health Programme 
(PHP). Thus, it is assessed whether the achievements of the programme:  
• correspond with its objectives  
• are achieved at reasonable resource use/costs    
• correspond with needs, problems and issues (of relevance to stakeholders). 
Furthermore, the impact of the programmes, projects, and activities on the improvement of public health policies in the 
Member States and at EU level is asse ssed. This is done by evaluating the extent to which the programme has achieved the 
intended outcomes/impacts, delivered inputs to policy, ensured consistent and complementary implementation with respect to 
the Member States' expected achievements  in the field of public health, and been implemented in accordance with the 
international public health aims. All this will be underta ken with a view to examining European added value.  
1.2 Methods  
The results of the evaluation are found by combining four types of information sources, namely desk study, e-survey, 
interviews and case studies - acknowledging the strengths and th e weaknesses of the different methods. The different sources 
contribute in different ways. While e.g. the e-survey has a widespread coverage of beneficiaries and other stakeholders 
compared with the interviews and case studies, the issues are, in turn, covered in less detail.  
In addition to these weaknesses, there ar e a number of caveats to be aware when  analysing the results of applying the 
evaluation methodology.  
The evaluation of the effectiveness of the PHP in contributing to European public health suffers from a lack of an explicit 
intervention logic that could facilitate the setting of clear and logically linked objectives and corresponding performance 
indicators. A consequence of intended results and impacts not being clearly set out is that it is difficult to assess whether t hey 
have been achieved. Hence, in practice - as  done in the present evaluation - the evaluator attempts to establish the invention 
logic for the programme, and while doing this, seeks to describe  how to measure objective achieve ment. The caveat is thus that 
the use of the assessment of objective achievement is associat ed with the additional uncertainty of target specification. 
Even without well-specified targets, an evaluation will analyse results and impacts envisaged to have been caused by the PHP 
interventions. This is, however, also not st raightforward - for at least two reasons. 
Firstly, changes to, for example, health policies and ultimately improvements to the health of groups of European citizens are 
typically the result of complex interactions. Since it is difficult to attribute the change in a given health outcome to a spec ific 
PHP intervention, the evaluation merely assesses whether the intervention has contributed to a change in the health outcome. 
Secondly, the counterfactual situation of what would have happened to the relevant health output, result, or impact indicators 
anyway - i.e. without the PHP intervention - is unobservable, an d furthermore it is in the given context considered difficult t o 
estimate.  
Furthermore, the fact that health improvements take time means that many of the results and impacts of the PHP interventions 
will not have materialised at the time of the evaluation - but may do so in the medium to longer term. Hence, a caveat is that the 
evaluation to some extent is limited to assessing the actual project deliverables. Another caveat is here that such speculation s, 
in particular by project participants, are likely to be too opti mistic - a caveat that in practice is relevant to all evaluatio n 
methodologies where assessments ar e based on subjective opinions. 
 691.3 Main results and conclusions  
1.3.1 European public health needs - relevance and European added value 
The extent to which the PHP has addressed the perceived and real needs concerns thr ee issues. Firstly, the extent to which the 
needs have been addressed in the annual wo rk plans (AWPs) and listed as a priority area is central. This is a precondition to 
funding of activities in the field. Secondly, it is important wh ether activities have actually been funded in the priority area . 
Finally, it concerns whether the needs have been addressed duri ng the implementation of the activities funded, if any, to the 
extent that some room for manoeuvre remains within the scop e of the project defined in the application and contract 
documents.  
In our view, the activities financed under the PHP have in general been relevant to the overall aim of the PHP, the general 
objectives and the priority areas lis ted in the annual work plans.  
This is in part a consequence of the far-reaching aim, objec tives and priorities of the PHP - making it difficult to identify p ublic 
health issues that may be considered as not relevant. The aim,  objectives and priorities of the PHP are very broad and thus may  
encompass a wide range of issues in the field of public health. 
Furthermore, the activities funded show a good coverage of th e work plan priorities. Only few possible gaps have been 
identified.  
However, during the PHP period projects have been funded under many different priority areas as defined in the annual work 
plans (AWPs). Taking into account the limited available financia l resources of the PHP, this may have diluted the potential 
effects of the individual projects  compared with a more targeted effort in sel ected areas. The point of view that there may hav e 
been too many priority areas was also put forward by the Court of Auditors in 2008 and Commission staff during this evaluation. However, since the PHP was the fi rst programme in the field of public health at EU level, it can be argued that it 
was wise and  necessary to fund a broad spectrum of activities; but today a more targeted effort in selected areas seems to be of 
crucial importance.   
In general, the projects selected for the in -depth case studies are found to have provid ed clear European added value. In this 
way, the projects selected may be regarded as success stories.   
There is no clear cut definition of Europ ean added value. According to the EAHC homepage, "European added value refers to 
the European dimension of the problem and of the project. Proj ects funded within the EU Hea lth Programme are expected to 
contribute to solving problems at the European level, and the expected impact of co-ordinatin g the work at European level 
should be greater than the sum of the impacts of national activities". Thus, our judgment is based on whether the projects are likely to have gained value by being addressed/implemented at the European level rather than at regional/national levels.  
It is the view of the evaluator that there could be even more focus on ensuring European added value of the funded activities -  
both through the compilation of annual work plans, including choice of priority areas, and through decisions on which applications to accept. This point of vi ew was also put forward by Commission st aff interviewed during the evaluation.  
1.3.2 Effectiveness 
The Court of Auditors (CoA) concluded in an audit of the PHP in 2008 that the programme lacks an explicit intervention logic 
that could facilitate the setting of clear and logically linke d objectives and corresponding performance indicators.  
While such lack of intervention logic can hinder the effectivene ss of programme implementation, it also has implications for an  
evaluation - if intended results and impact s are not clearly formulated, it is difficu lt to assess whether they have been achie ved. 
However, a programme without well-specified targets in the programme documents is not the same as saying that the 
programme does not have objectives and a plan for reaching thes e objectives. The case studies illustrate that there is a clear 
logic between the objectives of the PHP and the projects funded, on the one hand, and the potential contribution of the project s 
to the achievement of the objectives  of the PHP, on the other hand.  
The evaluation has found that the projects funded by the PHP have delivered a number of concrete results in the form of 
reports, articles, websites, training etc. The case studies also demonstrated that the programme has supported the establishmen t 
and maintenance of networks and sharing of experiences across  Europe. The case studies indicate that the projects in general 
have strong potentials to contributing to the preparation, deve lopment and implementation of public health policy initiatives. 
The evidence of such contributions was, ho wever, limited. This was confirmed by interviews with Commission staff. It seems 
that the dissemination of project results is not always targeted to policy makers. In addition, the results of the projects are  not 
always reported in a systematic and transparent way in the fi nal reports, and not all final reports are available on-line. 
 70Based on the case studies, we believe that most of the projects funded by the PHP have produced evidence, data or 
methodologies with significant value. This view was confirmed by the beneficiaries taking part in the e-survey. However, only 
few good examples were provided by Commission staff during interviews. The case studies indicate that it may be more 
difficult in general to justify recurrent projects in terms of new results. However, continued funding may be justified on othe r 
grounds, e.g. to ensure sustainability. 
The projects funded by the PHP have also helped transmit expe rience/best practices to and fro m health stakeholders. This 
conclusion is based mainly on the case studies, but confirmed by interviews with Commission staff. Networks and conferences 
may be accentuated as good examples in this regard. However, the extent to  which such transmission has actually taken place is 
not well documented. 
The dissemination of project output and results is central to reach users and to achieve the PHP objectives. Both the 
Commission and the beneficiaries have a responsibility in this regard. The Commission makes available information on the 
output and results of projects to the public on the EAHC website, including in the project database, and by organising 
conferences. According to Commission staff in terviewed as part of the evaluation, the Commission could do more in this field 
but is restrained by lack of resources. The case studies revealed that in some cases beneficiaries have done a considerable eff ort 
to disseminate project results, e.g. through publication of articles, website, training seminars and conferences. In other case s, 
the dissemination efforts have not been targeted to all relevant stakeholders. 
Most of the budget is allocated to calls for proposals. In recen t years, the use of calls for tenders has become more common to  
achieve more focused outcomes. Furthermore, direct grant agreements are considered important to ensure cooperation with 
international organisations at the strategic level and the pooling of resources. Challenges posed the existing financial 
instruments include ensuring sustainability. Networks may need continued funding to maintain activities. Furthermore, a three-year funding period may not always be suffi cient to cover the whole project cycle.  
The Commission has already responded to some of the limitations of the financial instruments by introducing new instruments 
in the second Health Programme 2008-2013, most notably ope rating grants and joint actio ns. Time will show whether 
introduction of these new instruments are sufficient to overcome the challenges enco untered during the implementation of the 
PHP 2003-2008.  
Another problem encountered in this evaluation is that small organisations do not always have the resources necessary to 
participate in the programme. This is especially true for or ganisations from Eastern Europe. Both the interviews with 
Commission staff and the case studies pointed to this problem.  
The case studies also revealed that the present funding model by which projects compete to obtain funding may promote good 
project start but may also entail less focus on dissemination and implementation of the results.  
Another important lesson from the case studies is that some trad itional public health researcher s applying for PHP funds seem 
to place less emphasis on aspects such as the link to EU public h ealth policies, implications in  terms of national policies and  the 
dissemination of project results be yond the narrow circle of experts directly dea ling with each topic. In such cases, it must b e 
considered whether the PHP is ultimately meant to support ev idence-based developments at the EU level or to subsidise 
ongoing research activities of the public health community.  
1.3.3 Consistency/complementarity 
According to the PHP programme decision, consistency and co mplementary should be ensured between activities implemented 
under the PHP and those envisaged or implemented under other policies and activities, in particular in the light of the requirement to ensure a high level of human health protection in the definition and implementation of all Community policies 
and activities.  
The Commission, the Member States and the beneficiaries all have a responsibility in this regard. At both Commission and 
project levels, coordination takes place to some degree, and this  evaluation observed a high degree of complementarity with 
other Commission policies and actions as well as activities in international organisations. However this was not done in a 
systematic way.  
The case studies selected for in-depth study generally show activity either regarding policy at national or EU level or other 
national/international activities ensuring consistency/complementarity in the field. Some projects have several activities at 
national and international policy level whereas others have na tional or international activities at programme and/or project 
level. 
 711.3.4 Support/involvement 
The e-survey revealed that most of the stakeholders are familiar with the EU public health policy in general. This also holds f or 
the general programme objectives and annual priorities of the PHP but to a somewhat lesser extent. In general, beneficiaries 
feel more familiar in this area than other stakeholders. Howeve r, other stakeholders employed by international organisations ar e 
also very familiar with the EU public health policy and the way the programme supports this policy. Stakeholders employed in 
the public administration of the Member Stat es feel less familiar with this area. Th is is an important observation as familiari ty 
is considered closely associ ated with involvement.  
Most beneficiaries have met barriers to r eceiving funding. Possible barriers include language problems, procedures and cultural  
differences. As an example, requirements to management might be difficult to fulfil by some PHP applicants as pointed out by 
Commission staff interviewed as part of the evaluation. Furthermore, some stakeholders might have problems finding the supplementary funding necessary to  participate in the programme. 
The needs of the different Member States may be translated in  terms of priorities in the annual work plans (AWPs), activities 
selected for funding and in terms of involvement in the implementation of the funded activities. The Commission, the Member 
States and the beneficiaries all have important roles to play in this regard.  
The implementation of the programme should promote national involvement at all levels, including actual involvement of 
Member States in the choice of priority ar eas for the annual work plans (AWPs). This is important to increase the potential use  
of project output and results at national level. Furthermore, it is important that the Commission raises awareness among 
national stakeholders that complementary funding is highly supportive. The introduction of joint actions as a new financial instrument with the second Health Programme 2008-2013 is a step in this direction.  
Through participation in the Programme Co mmittee, the Member States have the opportunity to influence the implementation 
of the programme. According to  Commission staff interviewed during the evaluation, the actual participation/involvement of 
Programme Committee members differs across countries depending on importance attached to the programme by national 
systems and individual factors. In general, Programme Committee members do not seem to consult operating stakeholders at 
national level to a sufficient degree. Furthermore, the frequent turnover of Programme Committee members tends to reduce participation/involvement by the country in question. 
The case studies point to good examples of  projects that ensure participation at national level, e.g. by appointing national 
coordinators with special knowle dge of the needs and terrain of  decision-making in their own countries. However, no evidence 
has been found as to whether and to what extent the project output is actually used at national level. Neither is evidence foun d 
as to what extent national interests are taken into account in the implementation of the projects.  
1.3.5 Monitoring 
Monitoring is a continuous and systematic process carried out during an intervention, which generates quantitative data on the 
implementation of the intervention but usually not its effect. The intention is to correct any deviation from the operational 
objectives and thus improve the performance of the progr amme as well as facilitate the subsequent evaluation. 
Progress has been made since the launch of the PHP to ensure th at the monitoring system delivers the information needed to 
support sound implementation of the programme. In our vi ew, there is still room for improvement. During interviews 
conducted as part of the evalua tion, Commission staff expressed that more resources should be allocated to the monitoring of 
the programme. A vast amount of information is collected through the online applications for funds under the second Health 
Programme. Furthermore, the beneficiaries are required to compile a final technical implementation report describing the 
process and deliverables produced. Relevant information on the activities funded should be registered in a database in order to  
ease the monitoring of the implementation of the programme, including the coverage and results of activities funded. Based on 
this register, regular reports on the implementation may be produced and distributed to relevant stakeholders.   
1.3.6 Sustainability 
By sustainability we understand the continuation of activities after the funding period has ended. Sustainability concerns both  
cooperation between project participants and the dissemination and use of project results. As regards the dissemination and use  
of project results, the most wide-ranging sustainability is achieved when activities are continued by other players and/or 
integrated into existing structures , e.g. through policy initiatives.  
This evaluation indicates that project results were sustained by  still being available on websites after the end of the project  
period and through follow-up projects funded by DG SANCO. Ho wever, little evidence has been found of the sustainability of 
project results though policy initiatives, neither at EU nor at national level.  
 72No evidence was found of compilation of systematic legacy plans to ensure sustainability of the projects.  
In addition to pursuing sustainability of outputs and results actually achieved, the sustainability of the established 
collaborations - that might deliver outputs and results also afte r the EC funding has ended - has been assessed. We believe tha t 
the EC funding has helped create critical mass of expertise from  a more fragmented expert structure through the establishment 
of networks and conference events, info days etc.  
1.4 Recommendations  
The table below provides an overview of our recommendations in  order of priority in each ev aluation dimension. The five 
highest ranked recommendations are marked in bold. 
Figure 0-1 Overview of recommendation s in order for each evaluation dimension in order of priority 
1 DG SANCO should reduce the number of priority areas in the annual work plans 
by allowing a maximum of five priority areas in each of the three strands to 
increase the impact within the priority ar eas, bringing them to not more than 15 
per yearly call.  (1st priority)  
2 DG SANCO should ensure that the priori ty areas in the annual work plans are 
focused and based on a thorough analy sis of needs and European added value. 
This analysis should be carried out by pu blic health experts versed in these 
issues. (4th priority)  
3 E A H C  s h o u l d  r e v e a l  g a p s  i n  t h e  c o v e r a g e  o f  a  p r i o r i t y  a r e a  b y  t h e  s u p p o r t e d  
projects to ensure better coverage in future project funding decisions. 1.Relevance and European added value 4 DG SANCO should earmark a part of the budget of each annual work plan to 
funding of activities in areas with the aim to tackle unexpected public health 
problems that may arise after the dr awing up of the annual work plan. 
5 DG SANCO should in collaboration with EAHC define clear performance 
indicators (success criteria) at programme  level in order to facilitate follow-up 
and evaluation of the achievements. These success criteria should be based on a 
thorough elaboration of the intervention logic underpinning the different areas 
and priorities of the programme.  (2nd priority)  
6 DG SANCO should earmark a part of the budget in the annual work plans as easy 
accessible funds towards additional diss emination efforts. These should be 
distributed based on a separate 'fast track' and simple application procedure. 
However, this might require a chan ge in the financial regulation. 2. Effectiveness 
7 EAHC should develop a final report templa te on outputs/resu lts/impacts to be 
used by all beneficiaries as a supplem ent to the technical implementation 
report. 
8 Member States (e.g. Programme Committee members) should at a regular basis 
collect information about relevant activities  at national level, e.g. through public 
consultations every two or three years,  and pass on this information to the 
Commission. 3. 
Consistency/compleme
ntarity 9 EAHC should in cooperation with DG SANCO and other DGs carry out regular 
mapping of activities under the framework programmes for research and 
development and thereby increase the motivation of other DGs to engage more 
actively in inter-service consultations. 4. Support/ 
involvement 10 EAHC and DG SANCO should pursue inclusion of Member States which appear 
inactive in the programme. These are typi cally countries with a relatively low 
GDP/capita. Inclusion could be pursued by providing technical assistance to 
write proposals (EAHC) or by increasin g the EC financial contribution (DG 
SANCO), possibly on the basis of an alternative cost model. (5th priority)  
 7311 EAHC should distribute an informatio n package with relevant targeted 
information about the programme to ea ch Programme Committee and National 
Focal Point members. 
12 EAHC should encourage that annual information days are still held at both EU 
and national levels to increase familiarity with the programme and annual 
priorities. 
13 Each Member State should establish a help  desk to provide support to potential 
applicants to overcome barriers relating to funding procedures and reporting. 
14 EAHC should compile monitoring report s on a yearly basis based on common 
management performance indicators. 5. Monitoring 15 EAHC should predefin e keywords for the categories of interventions, health 
issues and the target groups. The projec t applicants must choose the keywords 
which best describe their projects. This improved information about coverage of 
health objectives will enhance both fundi ng decisions and evaluation exercises. 
16 EAHC should compile brief descriptions of  project results, co mpatible with the 
existing database, including considerat ions about use potential and policy 
recommendations if relevant, and disse minate these to Commission staff and 
national stakeholders at the political level, under the caveat that such 
procedures do not increase the administrative burden for the end user and grant 
holders unnecessarily.  (3rd priority)  6. Sustainability 17 Project applicants should e requested by EAHC to incl ude considerations about 
involvement of potential users during pr oject implementation and sustainability 
in their project applications. 
 
 
               
 74ANNEX  4 – KEY  MESSAGES  AND  EXECUTIVE  SUMMARY  OF THE  MID-TERM  
EVALUATION  OF THE  HEALTH  PROGRAMME  2008  - 2013 
 
1. KEY  MESSAGES 
1.1 Key messages of the evaluation  
1.1.1 Conception  
HP objectives are broad and therefore cover main Public Health concerns 
• The overall objective of the Hea lth Programme is to support actions that are designed to be 
complementary to health policy actions and systems at the national level. Specifically, the Health 
Programme targets or aims at th e following three main objectives as per programming documentation: 
(1) Improve citizens’ health security (HS); (2) Prom ote health and reduce hea lth inequalities (HP); (3) 
Generate and disseminate health information and knowledge (HI). 
• The interviews with stakeholders (e.g. EAHC of ficials; Programme Committee members and national 
focal points; Policy Committee members; officials of other EU financial programmes and 
representatives of International Or ganisations) have indicated that ove rall, interviewees thought that 
the objectives of the Health Programme cover much of the main needs of the area of Public Health in Europe. However, especially Programme Committee members thought that the objectives are very 
broad to the extent that most health-related issues could fit under them under any circumstances. 
• The results of the online survey with  action leaders show that the vast  majority of respondents felt that 
the Health Programme is focusing on relevant prior ity areas addressing the main public health issues 
in Europe, but that more individual thematic areas close to thei r interest or area of work should be 
included or considered in the overall design of the Programme. 
HP actions contribute to EU wide effects 
• While the Health Programme needs to focus more on setting clear and tangible  health objectives, these 
can only be reached if the actions  funded respect well defined, prove n EU added valu e criteria. The 
EAHC has developed seven ways on  which to assess European added value, developed on the basis of 
the subsidiary principle and the Lisbon Treaty. The case studies have illustrated that actions funded 
under the Health Programme cont ribute to EU wide effects as defined by the EAHC, most 
prominently in the areas of the prom otion of best practice (“ (...) to grant to all citizens the benefit from 
state of the art best practice, a nd to ensure the capacity building where necessary”) and professional 
networking (“(...) the priority expe cted results have the objective to support or crea te networking 
activities”). According to the case studies, EU added value is least seen in the area of “Free movement 
of people” (“(...) to ensure high quality P ublic Health across EU Member States”). 
• Programme Committee members were confident that  the Health Programme can and already does 
contribute to EU-wide effects, e.g. by pooling resour ces across the EU and working on joint solutions. 
Without the Health Programme there would be fe wer networks related to public health and less 
projects between Member States. 
• The online survey with action leaders also suggests that most actions close to their area of interest 
would not have taken place or would have been undertaken with a less  ambitious scope in the absence 
of Health Programme funding. 
 751.1.2 Design  
Scope for efficiency gains by improving the design of HP 
• Desk research has shown that the funding of actio ns is not spread equally over the three main 
objectives of the Health Programme , and is not targeting the prior ity areas to an equal extent. 
• According to the stakeholder interviews carried out , important efficiency gains could be achieved by 
reducing the number of priority ac tions of the Health Programme, and by targeting them at health 
issues that are of most concern to Member States. 
Good utilisation but mixed satisfacti on on the new financing mechanisms  
• Desk research has shown that since the introducti on of the current Health Programme, actions are 
more widely dispersed among the diffe rent financing mechanisms. It al so suggests that the range of 
different financing mechanisms are better suit ed to accommodate the actions funded, and might 
increase the effectiveness of their outputs. 
• Stakeholders, among them members of the Programm e Committee, had mixed perceptions of the new 
financing mechanisms in general and the use of specific mechanisms to increase effectiveness in the delivery of the outputs. 
• EAHC officials viewed the introduc tion of new financing mechanisms as a very positive development 
in general and highlighted the point that differe nt financing mechanisms fulfil different purposes. 
• The case study exercise conducted over a number of th ematic areas has revealed  that, regardless of the 
financing mechanisms actions are funded under, some  of the actions assesse d face similar challenges 
and limitations in that they lack clear intervention logics, definiti on of objectives, target groups and 
dissemination strategies, which might  have a negative effect on the delivery of their outputs. 
1.1.3 Management
 
Outsourcing of HP management to EAHC  has significantly improved delivery 
• The online survey and the case studies have rev ealed that overall, action leaders found the Health 
Programme’s selection and management procedures  appropriate and well executed, though they would 
benefit from more support and guidance from the side  of the EAHC in the design of the proposal, the 
running of actions and the dissemination of results. 
Dissemination of results is one of  the main challenges of the HP 
• According to the stakeholder interv iews undertaken, the dissemination of results is one of the main 
issues of the current Health Programme. Cert ain stakeholder groups, e.g. Programme Committee 
members, feel not sufficiently informed about the re sults of actions funded. Given the overall role and 
function of PC members at  national level, this seriously limits the impact of the Health Programme. 
• The case study assessment has shown that there is sc ope for improvement for actions to better outline 
their dissemination plans to make their results publicly available to a wide-spread audience. In 
addition, target groups of individua l actions are defined to varying extents in the documentation, and 
often kept very generic and / or not easily quantifiable. Most actions do not seem to have a clear 
dissemination plan for their outputs, further limiting the impact of the Health Programme. 
• Respondents to the online survey suggested that, in order to improve the dissemination of results, the 
European Commission could increase the dissemin ation by making them available through their own 
publications, ideally in a broad ra nge of languages and specifically ta rgeting relevant stakeholders. 
 761.2. The five highest ranking recommendations  
• The evaluation recommends that DG SANCO looks to refine the objectives of the Health Programme 
for them to be more tangible and focussed on certai n public health issues, especially those that are 
difficult for Member States to reach  individually, and for indicators to  be determined so that progress 
can be measured in terms of the extent  to which these objectives are achieved. 
• To ensure an effective implementation of the Health Programme, it is recommended that DG SANCO 
develops a plan for long-term targets to be ach ieved by the Programme. In conjunction with other 
policy implementation tools, appropriate priority act ions could then be set, financing mechanisms 
selected and an appropriate spread among the obj ectives and priorities en sured. DG SANCO needs to 
explain and document this process clearly and provide a rationale / justification behind varying levels 
of funding for each objective. 
• It is also recommended that DG SANCO and the Ex ecutive Agency provide clearer guidelines at 
proposal stage and encourage / follow-up their usage, for example:  
o intervention logics and theories of change to participants (definitions and very clear examples 
of Inputs, Outputs, Results, Outcomes and Impacts of an action); 
o setting indicators that could pr ovide an insight into the extent  to which the outcomes are being 
/ have been achieved. Without th ese it is difficult to determ ine how effective an action has 
been and the extent of its impact at the point of assessment; 
o how to set SMART objectives in order to effectively measure progress; 
o definitions of what is required in certain sections  of the application form, i.e. “evidence base”, 
given that applicants might have different understandings of certain  terms used (without 
interfering in the peer revi ew process and without encro aching on the capacity of the 
applicants to formulate the evidence base);  
o assessing potential “EU added valu e” along clear and quantifiable cr iteria (as stated above, this 
aspect is crucial and therefore guidan ce on it should be made very clear); 
o defining target groups / dissemina tion plans / evaluation plans. 
• The EU added value of actions should feature to a greater extent in the application process. As a 
condition sine qua non, applicants should describe the type of EU added value their action will bring, 
potentially making use of the seven EU added value criteria developed by the EAHC and used as part 
of this evaluation. The template used for assessi ng EU added value, develo ped as part of this 
evaluation, might be considered a starting point fo r the future assessment of EU added value in 
proposals. Applicants could provid e a self-assessment of EU added value which would be assessed 
and validated during the evaluation process. 
• In order to ensure the dissemination of results by actions themselves, the evaluation recommends that 
actions allocate parts of the EC funding to dissemin ation, and to clearly outline this in the financial 
statements of proposals. Once actions come to an end, it is recommended that DG SANCO makes 
better use of its dissemination channels, i.e. th e Public Health website, DG SANCO publications, 
newsletter etc. In order to reach national po licy makers, DG SANCO and the EAHC should start 
disseminating a list of HP project  results on an annual basis, i.e. to inform Policy Committee 
members. DG SANCO could also di sseminate information to the European Parliament and the 
Committee of the Regions to promote the applica tion of results at the regional / local level. 
 
 
 
 772. EXECUTIVE  SUMMARY 
2.1 Background, objectives and approach  
The Health Programme 2008-2013 , together with the Health  Strategy, was adopted on 27th October 
2007, and put in place following Decision No 1350/2007/EC44. The Programme covers the period from 1 
January 2008 to 31 December 2013 and was introduced  as the main financial tool through which the 
principles and objectives of the Strategy would be achieved. It wa s endowed with a total budget of 321.5 
million Euros  to be allocated to projects that could comp lement, support and add value to national health 
policies. In this context, projects were expected to include and i nvolve actors from di fferent participating 
Member States and their results shou ld be applicable to other countries  and regions across Europe and in 
its neighbourhood. 
The purpose of the mid-term evaluation was to a ssess the Health Programme  2008-2013 at its half-way 
point in order to steer the preparation and design of  the post-2013 programming period and take stock of 
the actions implemented to date. More specifical ly, the Tender Specificati ons requested that the 
evaluation: 
1. Provide an overview of the implementation of th e Health Programme in the first three years, 
including a quantitative and qualita tive description of the priorities set, the financial mechanisms 
used (e.g. operating grants, joint actions, tenders etc), the benefici aries reached, the actions funded, 
and the intended results. 
2. Assess the relevance, effectiveness and efficiency  of the funded actions, taking into consideration 
the fact that the majority  of the actions funded will not have provided all the deliv erables and final 
reports when the evaluation takes place, so the assessment of impact will have to be forward-
looking. 
3. Assess the consistency and complementarity with other relevant EU fina ncial programmes funded 
from the EU budget, instruments and funds, and the utility of th e Health Programme. 
4. Measure the progress made in the light of the re commendations in previous evaluations and audits 
and their follow-up, the efficiency in the use of resources and the European added value. 
To fulfil the above objectives, the evaluato rs developed a methodology primarily based on: 
• an in-depth analysis of a samp le of actions funded under the Health Programme, to assess their 
relevance, effectiveness, efficiency, utility, a nd their contribution to fu lfilling the Programme’s 
objectives by 2013; 
• a stakeholder interview programme (incl. EAHC  officials; Programme Committee members and 
national focal points; Policy Committee members; Officials of other EU financial programmes; 
Representatives of International Organisations); 
• an e-survey with leaders of all actions f unded under the Health Programme between 2008 and 
2010;  
• interviews with external public  health experts who were involved in the evaluation of HP 
proposals; and, 
• an extensive desk-based research exercise, par ticularly examining the Pr ogramme’s Intervention 
Logic and it’s consistency and compleme ntarity with other EU Programmes. 
                                                 
44  Official Journal L 301 of 20.11.2007, pp. 3-13.  
 78The conclusions and recommendations presented in  the following section are grouped around three 
components considered as being important for a programme evaluation, namely conception (the 
idea/notion behind the programme), de sign (the plan that establishes a relationship between programme 
objectives and resources) and ma nagement (the practical organi sation and coordination of the 
programme).  
2.2 Key conclusions
 
Conception 
HP objectives are broad and therefore cover main Public Health concerns 
The objectives of the Health Programme (2008-2013)  are far reaching and encompass most areas of 
Public Health in Europe. The Programme currently l acks a clear intervention logic. The intervention logic 
could be improved by better determining and descri bing: 1. the overall goals of the Programme, 2. how 
those goals might be reached, and 3.  how progress can be accurately an d effectively measured against the 
goals. 
Process in place for determining priorities in AWPs 
There is a process in place for determining prioriti es in the Annual Work Programme (AWPs) and for 
ensuring their alignment with the overall objectives of  the Health Programme. Ho wever, this process is 
not considered as particularly clea r or consistent. Public health offi cials from different parts of DG 
SANCO do not all employ the same pro cess for determining priorities. Ther e is no overarching systematic 
approach defined for this. In addition, setting priori ties in the AWPs has not fu lly taken into account the 
needs of Member States in the area of Public Health. It would be beneficial to create a mechanism through 
which Member States could determine common goals a nd all contribute to the pr iority-setting process. 
HP actions correspond to HP objectives 
The HP actions selected for funding correspond to the objectives of the Health Programme to a large 
extent. This is ensured through the selection process for actions, in wh ich applicants ha ve to outline the 
extent to which their proposed action will comply with  the priority areas in the AWPs as well as the 
overall objectives of the Health Programme. 
Too early for assessment of extent to whic h actions’ results ac hieve HP objectives 
At this stage, it is too early for an  assessment of the extent to which the results of actions funded achieve 
the objectives of the Health Programme, given that most actions  are still ongoing and key outputs have yet 
to be delivered. In the majority of cas es there appears to be little devia tion to what is de tailed in proposals 
in terms of action ou tputs and outcomes. 
HP actions contribute to EU wide effects 
The majority of actions funded under the Health Progr amme have contributed to EU wide effects to a 
great extent when taking into acc ount the seven ways of which to a ssess European added value developed 
by the EAHC. The case study assessment shows that EU  added value generated by the HP actions appears 
to feature most prominently in the areas of “promoti on of best practice” and “n etworking”, and is seen 
least in the area of “Free movement of people”. “Economies of scale” are foreseen in the majority of 
actions, though there is little  evidence of any actions be ing able to quantify this effectively and accurately. 
In addition, it is envisaged that the results of many ac tions will be carefully examined and potentially used 
 79when considering future legislation, formulating policy and / or basing decisions on public health 
spending. 
Many HP actions would not have gone ahead in absence of HP 
Most actions would not have taken place or would have been undertaken with a less ambitious scope in 
the absence of Health Programme funding. The Health Programme  appears to be the main funding 
mechanism in place to support such a dive rse range of health-related activities. 
Design 
Scope for efficiency gains by improving the design of HP 
Efficiency gains could be achieved by reducing the num ber of priorities and ta rgeting them at health 
issues that are of most concern to Member States and where there is real value id entified at intervening at 
EU level. Determining the potential “EU a dded value” of interventions is crucial. 
New financing mechanisms have been well taken up  
The introduction of specific and new financial instruments has generally been received positively and all 
instruments have been utilised. However, it is still to o early to say if some financial instruments have led 
to more effective outputs than others. Several ac tions funded under the different financing mechanisms 
face similar challenges. With all of them there is scope for proposals and interim reports to better define 
the action’s objectives, to outline the intervention logi c, target audiences, the dissemination strategy of 
deliverables and the “EU added value” of the action. 
Selection process seems to ensure selectio n of appropriate/co mpetent applicants 
The selection process of actions funded under the Health Programme  is strengthened in ensuring that 
appropriate and competent applican ts are selected for funding. Howeve r, while in theo ry the current 
process offers equal access for all organisations to th e Programme, consortia made up of “tried and tested” 
organisations seem to be more likely to be awarded f unding than those that are sm all / new to the process. 
The EAHC is aware of this problem and has take n steps to support smaller organisations in their 
application process, i.e. by deve loping a series of seminars intr oducing the Health Programme and 
explaining the application process. 
Smaller organisations are challenged by application process 
Smaller organisations find the current  application process challenging given its length and complexity. 
Such organisations might not have the necessary fi nancial or human resource s for putting together a 
proposal, and the process might incur high costs for them if proposals are submitted but not won. 
 Level of consistency / complementarity between HP actions and other EU policies 
There is a level of consistency and complement arity between the actions funded under the Health 
Programme and other EU policies and activities, as well as activities at the national and international level, though this varies in its  extent according to topic areas. 
Several of the actions funded under the current Hea lth Programme are follow-on actions from previous 
interventions funded through the EU. Ac tions also often use or build on th e results of interventions funded 
under the Research Framework Programmes or the previo us Health Programme. It is therefore necessary 
to share data more effectively between actions f unded under the Health Program me and similar activities 
at national, European and international level, as well as between DG SANCO a nd other DGs, in order to 
create synergies and to better identify overlaps. 
 80Management 
Outsourcing of HP management to EAHC  has significantly improved delivery 
The outsourcing of the management of the Health Pr ogramme to the EAHC has resulted in a significant 
improvement in its delivery. While action leaders are generally satisfied with the selection and management procedures currently in place, they would nevertheless benefit from more support and 
guidance from the side of the EAHC in the desi gn of proposals, the runni ng of actions and the 
dissemination of results. However, the work load  of individual EAHC project officers is high, and 
providing more support at th e current staffing levels  would be a challenge. 
Scope for improvement of moni toring / management of HP 
The EAHC also takes responsibility for monitoring a nd assessing the quality of dissemination plans and 
checking the deliverables produced. However, evidence suggests that monitoring data and results are not 
actively communicated to external st akeholders. In addition, the evaluation has not found any evidence of 
what procedures are in place at Commission or Member State level to incite stakeholders to make use of 
actions’ results. 
Dissemination of results is one of  the main challenges of the HP 
The dissemination of action results is  one of the main challenges of the current Health Programme and 
should be improved. There is scope for more detailed  dissemination strategies  in proposals and interim 
reports, and for target audiences to be better defined. In addition, there is scope for DG SANCO / the 
EAHC to play a more active role in disseminating resu lts, particularly when an action has come to an end. 
The dissemination of results at nati onal level seems to be one of the biggest challenges for the Health 
Programme. In particular, there would be value in targeting national policy makers directly, as it is 
unlikely that they proactively look for results of actions themselves. 
 
2.3 Key recommendations
 
Based on the findings and conclusions of the mid- term evaluation, the following recommendations are 
made to address existing shortcoming and take advantage of room for improvements: 
Conception 
HP objectives to be more tangible and focussed 
The evaluation recommends that DG S ANCO looks to refine the objectiv es 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 individu ally, and for indicators to be determined so that progress can be 
measured in terms of the extent to which these objectives are achieved. 
Better define strategic framework of the HP 
It is also necessary to better define a strategic framework for the Health Programme, in which: 
• priority areas clearly fit with and compleme nt the objectives of the overall programme; 
• clear targets for the Health Programme  / the priority areas are introduced; 
• a clearer rationale on how DG SANCO has arrived at the priorities in Annual Work Programmes 
should be provided. 
 81DG SANCO to develop a plan for long-term targets 
To ensure an effective implementation of the H ealth Programme, it is recommended that DG SANCO 
develops a plan for long-term targets to be achieve d by the programme. Appropriate  priority actions could 
then be set, financing mechanisms selected and an appropriate spread among the objectives and priorities 
ensured. DG SANCO needs to explain and document this process clearly a nd provide a rationale / 
justification behind varying leve ls of funding for each objective. 
Consult national health expert s when setting priority areas 
It would be advisable to introduce a framework / a mechanism through which national health experts 
could be consulted and engaged earlier in the process of setting priority areas to determine the main health 
issues of common concern to Member States. It is therefore recommended that DG SANCO works on 
mechanisms beyond what is already organized via the Programme Committee to make this possible. 
Design 
Retain current financing mechanisms / Consult ac tion leaders on their ex periences with the new 
FMs 
The current system of financing mechanisms should be continued and action leaders should be consulted 
on their experiences of the new financial mechanisms, the pros and cons of each, and what aspects they 
would change / improve at the end of each project. 
Retain current proposal requirements to show  alignment of actions with HP objectives 
The evaluation also recommends that  the requirement for proposals to outline the extent to which their 
proposed action complies with the prio rity areas in the AWPs as well as the overall HP objectives should 
be retained. DG SANCO officials should continue a ssessing proposals according to their policy relevance, 
and external evaluators should continue rating proposals accord ing to their evidence base. 
EU added value of actions should feature to a greater extent in th e application process 
The EU added value of actions should feature to a gr eater extent in the applic ation process. Applicants 
should describe the type of EU added value their acti on will bring, potentially making use of the seven EU 
added value criteria developed by the EAHC  and used as part of this evaluation. 
The template used for assessing EU added value, devel oped as part of this eval uation, might be considered 
a starting point for the futu re assessment of EU added value in proposals. Applican ts could provide a self-
assessment of EU added value which would be asse ssed and validated during the evaluation process. 
Management 
EAHC to monitor organisations applying for funding 
The EAHC should continue undertaking satisfaction su rveys with applicants selected for funding and 
those rejected to remain aware of problems that organisations might encounter  when applying for funding 
under the Health Programme. The EAHC could also take stock of the type  of organisation that are funded 
/ rejected to ensure an equa l access for all applicants to receive funding in the future. 
The EAHC should also carry out a more in-depth as sessment of a sample of  actions every year, for 
example in a case study format sim ilar to the one undertaken for this  evaluation. This would enable 
project officers to develop a more in-d epth assessment of actions funded, but  also to have data available to 
publish and further disseminate amo ng stakeholders involved or interested in the Health Programme. 
 82DG SANCO / EAHC to provide clea rer guidelines at proposal stage 
It is also recommended that DG SANCO and the Executive Agency provide clearer guidelines at proposal 
stage and encourage / follow-up their usage, for example: 
• intervention logics and theories of change to participants (defin itions and very clear examples of 
Inputs, Outputs, Results, Outcomes and Impacts of an action); 
• setting indicators that could provi de an insight into the extent to which the outcomes are being / 
have been achieved. Without these it is difficult to determine how effective an action has been and 
the extent of its impact at the point of assessment; 
• how to set SMART objectives in order to effectively measure progress; 
• definitions of what is required in certain sectio ns of the application form, i.e. “evidence base”, 
given that applicants might have different understandings of certain terms used (without 
interfering in the peer re view process and without encroaching on the capacity of the applicants to 
formulate the evidence base); 
• assessing potential “EU added value”  (as stated above, this aspect is crucial and th erefore guidance 
on it should be made very clear); 
• defining target groups / dissemina tion plans / evaluation plans. 
Actions and their results need to be built into a regular reporting system 
In order to ensure the dissemina tion of results by actions themselv es, the evaluation recommends that 
actions allocate parts of the EC f unding to dissemination, and to clea rly outline this in the financial 
statements of proposals. 
Once actions come to an end, it is recommended th at DG SANCO makes better use of its dissemination 
channels, i.e. the Public Health website , DG SANCO publications, newsletter etc. 
In order to reach nationa l policy makers, DG SANCO and the EAHC  should start disseminating a list of 
HP project results on an annual basis, i.e. to in form Policy Committee member s. DG SANCO could also 
disseminate information to the European Parliament  and the Committee of the Regions to promote the 
application of results at the regional / local level. 
Data to be shared more effectively 
To make full use of the consiste ncies and complementarities of HP  actions with other actions at 
international, European and national level, it  is recommended that data is shared more. 
 
 
 
 83ANNEX  5 – DISCUSSIONS AND CONSULTATIONS WITH HEALTH STAKEHOLDERS AND INSTITUTIONAL INTERLOCUTORS  - SUMMARY  
National Focal Points and other 
health stakeholders 
Summer School of Public Health, 
Minorca-Spain 20-21/09/2010 National Focal Points meeting 
21 January 2011 MS Representatives in Informal  
Ministerial in Gödölö-Hungary 
4-5/04 2011 Health stakeholders and civil 
society in Health Policy Forum 
Brussels, 19/05/2011 
How to increase the impact of the 
Health Programme?  
Participants gave concrete examples of 
actions financed under the EU Health 
Programme that  has helped in the development of national policies and 
programmes:  
 
• by providing the model for actions 
taken at national level  (INCLA-SNS 
developed on the basis of ECHI model of 
key indicators  adopted in Spain in 2005 
 
• by maintaining high on the national 
political Agenda health issues that the 
EU Health Programme had dealt with  
(Health inequalities  & social deter-
minants of health considered  key priority 
for the Spanish EU Presidency in 2010 - 
addressing specifically the Roma ethnic minority → adoption of a new public 
health law in Spain and the support of 
the Joint Action "Inequalities in Health" funded under the Health programme in 
2010.  
 
• by sharing operati onal experience 
and exchanging expertise and 
knowledge (the case of DETERMINE 
project)  Main orientations:  
HU (Presidency) underlined the need to 
link the Health Programme with:  
 
• the EU Treaty (communicable 
diseases and health threats, tobacco, 
alcohol) 
 
• EU2020 and digital agenda 
(innovation partnership, chronic diseases, 
healthy ageing; digital agenda – cross-
border aspects, activ e and healthy ageing, 
supporting health systems),  and 
 
•  existing legislation (Cross-Border 
Health Directive as a clear base for future work).  
 
HU underlined a practical approach:  
 
─ taking into account national 
challenges (new health 
systems/structures – modernisation, 
sustainability, healthy ageing) , and 
  
─ EU added value (networks, 
exchange of expertise to build 
research, cohesion).   
 
  
 
 Main orientations:  
All MS unanimously supported the 
need for the future EU Health 
Programme.  While some underlined it 
should be more focused, cost-efficient, 
based on actions of proven EU added 
value, other Ministers underlined it 
should support existing objectives and wide range of actions.  
 
 Specifically, 
 
BE, LT, IE, NL:  implement adopted 
and planned Council conclusions  
(cross-border, health  threats package, 
joint procurement of vaccines, cancer, 
chronic diseases, pharma). 
 CY: 
supports continuation of the 
Programme with more active participation 
of MS . 
 
SE and EL:  no need for major changes . 
Financial procedures should be  
transparent and simplified . 
 
ES: focus on strategic alliance with 
pharmaceutical industry  
 Main orientations:  
The Forum reasserted that it is 
fundamental to have a PHP,  especially 
for patients , and to support health 
literacy and the fight against health inequalities. 
 
The current financial mechanisms for EU public health should at minimum be 
maintained. 
 A strong emphasis should be put on 
health determinants   
 
the Programme should ensure that it is 
relevant to immediate health problems .  
 
A human rights approach  to support 
EU Public Health was recommended – one that is supported by proper resources 
and that reflects non discrimination in 
healthcare provision.  
Several people expressed their worry for 
the future of the PHP , as they fear that 
less support will be provided to the work 
being done towards improved public 
health and its outcomes.   
 
 
 
 84Future Health Programme:  
 
further develop actions to  
• enhance dynamic health systems , 
• support evidence based policy 
making ,  
• be an instrument to support the 
exchange of experi ences and practices 
and the creation of knowledge 
resources ,  and 
• support research and actions related 
to professional and patient mobility . 
 
The EU Health Programme should be 
maintained and developed further , in 
order to  
• support the establishment, 
extension and operation  of 
EU-wide networks, and  
• emphasise EU-wide activities 
in key priority areas, including research support in 
decision making.  
•  
The financing procedures  should be 
designed and regulated in a way to allow 
the participation of each and all 
Member States and players, including 
those with limited financial resources  
and institutional capacities,  from civil 
society and academia, support exchange 
of experiences and best practice all 
across the EU. 
 Other health topics: 
 
 
Sustainability & Health systems 
reform  (PL, MT, PT, CZ, HU) 
 
Healthy ageing & Innovation 
Partnership, old people, dementia  (FI, 
MT, CZ, IT, HU) 
 Health inequalities  (LT, FI, DK, PT) 
 
Inter-sectoral links  (FI) & especially 
use of structural funds in health  (MT, 
SK, HU, CZ) 
 Cancer (MT, DK, SK, IT) 
 
Non-communicable & chronic diseases  
(MT, DK, IT, HU)  
 
Communicable diseases as they are re-
emerging  (HU, MT, CZ) 
 Alcohol  (FI, DK, HU) 
 
Tobacco  (HU, DK) 
 
Mental Health  (FI, DK) 
 
Promotion and prevention, including 
promoting healthy lifestyle  (DK, CZ) 
 Nutrition (DK) & Obesity  (FI) 
 
HTA  (MT) 
 
Sexual health policy  (MT) 
Networks, exchange of expertise & 
best practice  (CZ)
 Other health topics:  
Health systems and organisation of 
health-care delivery (BE, FI, IE, LT, 
NL, PL, PT, UK) 
Ageing of population   (IT, LT, NL, PT) 
 
Health inequalities  (LT, PL, SE, UK) 
Health in all policies  (ES, PL, PT, SE, 
UK)  
Rare diseases (FR) 
Major and Chronic diseases (FI, IT, 
NL, PT, BE)   
Communicable diseases and vaccines  
(BE, FR, NL, SE, UK) 
Prevention/Health Determinants 
(alcohol, obesity, tobacco etc)  (FI, IE, 
SE, ES, PT) 
Mental Health  (FI) 
Health promotion/lifestyles  (IT, PT) 
Investment in Health Technology  
(FI, IE, IT, LT, NL, PL) 
e-health  (IT, NL, PT) 
 
 Health indicators  (IT) Other health topics:  
Prioritisation of projects  within the 
Programme should be discussed with 
stakeholders  and that the Programme 
has longer as well as shorter terms goals.  
 to support health literacy  and the fight 
against health inequalities . 
 The difficulty to access  the Programme 
was raised by some members, even if 
they understood the need for strict rules for the use of EU funds. 
 
In the areas of funding, we need a 
balance between Joint Actions and 
Core funding added a member.  
 Indicators: use economical indicators  to 
measure the impact of the PHPs as well 
as other aspects such as the 
environment, housing and transport. 
 
 
 85ANNEX  6 – LIST  OF HEALTH  LEGISLATION  AND  LEGISLATION  ON  PHARMACEUTICAL  
PRODUCTS  AND  MEDICAL  DEVICES   
 
NUMBER DATE TITLE 
ART. 168 – BLOOD, ORGANS, TISSUES AND CELLS  
BLOOD  
Directive 2002/98/EC of the 
European Parliament and 
the Council 27.01.2003
OJ L 33 
08.02.2003setting 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 
Commission directive 
2005/61/EC 30.09.2005
OJ L 256 
01.10.2005Having regard to Directive 2002/98/EC of the European 
Parliament and of the Council of 27 January 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 
Commission directive 2005/62/EC 30.09.2005
OJ L 256 
01.10.2005implementing Directive 2002/98/EC of the European Parliament 
and of the Council as regards Community standards and specifications relating to a quality system for blood 
establishments 
Commission directive 2004/33/EC 22.03.2004
OJ L 91 
30.03.2004implementing Directive 2002/98/EC of the European Parliament 
and of the Council as regards certain technical requirements for 
blood and blood components 
ORGANS  
Directive 2010/45/EU of the 
European Parliament and 
the Council 07.07.2010
OJ L 102 
06.08.2010on standards of quality and safe ty of human organs intended for 
transplantation. 
TISSUES AND CELLS  
Directive 2004/23/EC of the 
European Parliament and the Council 31.03.2004
OJ L 102 
07.04.2004on setting standards of quality and safety for the donation, 
procurement, testing, processi ng, preservation, storage and 
distribution of human tissues and cells. 
Commission directive 
2006/86/EC 24.10.2006
OJ L 294 
25.10.2006implementing Directive 2004/23/EC of the European Parliament 
and of the Council as regards traceability requirements, 
notification of serious adverse reactions and events and certain 
technical requirements for the coding, processing, preservation, 
storage and distribution of human tissues and cells 
Commission directive 2006/17/EC 08.02.2006
OJ L 38 
09.02.2006implementing Directive 2004/23/EC of the European Parliament 
and of the Council as regards certain technical requirements for 
the donation, procurement and testing of human tissues and 
cells 
Only important basic legislation has been retained here, for the other legislation in relation with blood, organs, 
tissues and cells please see: 
http://ec.europa.eu/health/b lood_tissues_organs/key_ documents/index _en.htm#anchor3 
 
 
  
 
 
 86NUMBER DATE TITLE 
ART. 168 - COMMUNICABLE DISEASES  
Decision No 2119/98/EC  of 
the European Parliament 
and the Council 24.09.1998
OJ L 268/1
03.10.1998 setting up a network for the epidemiological surveillance and 
control of communicable diseases in the Community 
Commission Decision 2000/57/EC  22.12.1999
OJ L 21/32; 
26.01.2000on the early warning and respon se system for the prevention 
and control of communicable diseases under Decision No 2119/98/EC of the European Parliament and of the Council. 
Commission Decision 
2000/96/EC   22.12.1999
OJ L 28/50 
03.02.2000on the communicable diseases to be progressively covered by 
the Community network under Decision No 2119/98/EC of the 
European Parliament and of the Council 
Commission Decision 2002/253/EC  19.03.2002
OJ L 86/44; 
03.04.2002laying down case definitions for reporting communicable 
diseases to the Community network under Decision No 
2119/98/EC of the European Parliament and of the Council 
Regulation (EC) 
No851/2004 of the European Parliament and of 
the Council  21.04.2004
OJ L 142/1; 
30.04.2004Establishing a European Centre for Disease and Prevention 
and Control 
Health Security initiative ongoing The Health Security initiative aims to review and update the 
existing EU legislation on communicable diseases (Decision 2119/98 and its implementing decisions) and to reinforce the 
collaboration at EU level on serious cross-border health threats 
from a global public health perspective ("all- hazards approach" taking account of the existing st ructures and mechanisms at EU 
level). 
Only important basic legislation has been retained here, for the other legislation in relation with communicable 
diseases please see:http ://ec.europa.eu/health/communicable_dise ases/key_documents/ index_en.htm#anchor1 
 
ART. 168 - SCIENTIFIC COMMITTEES 
Commission decision 
2010/309/EU  03.06.2010 amending Decision 2008/721/EC as regards indemnities paid to 
members of scientific committees and experts in the field of consumer safety, public health and the environment. 
Commission Decision 
2009/566/EC  27.07.2009
OJ L 196, 
28.07.2009 amending Decision 2008/721/EC as regards indemnities paid to 
members of Scientific Committees and experts in the field of 
consumer safety, public health and the environment  
Commission Decision 
2009/146/EC  19.02.2009 on the appointment of t he members and advisors of the 
Scientific Committees and the Pool set up by Decision 
2008/721/EC 
Commission Decision 
2008/721/EC  05.08.2008
OJ L 241, 
10.09.2008 setting up an advisory structure of Scientific Committees and 
experts in the field of consumer safety, public health and the 
environment and repealing Decision 2004/210/EC  
  
  
 
  
 
 87NUMBER DATE TITLE 
ART. 114 - TOBACCO  
Directive 2001/37/EC of the 
European Parliament and 
the Council 05.06.2001
OJ L 194 
18.07.2001on the approximation of the laws, regulations and administrative 
provisions of the Member Stat es concerning the manufacture, 
presentation and sale of tobacco products 
Directive 2003/33/EC  of the 
European Parliament and the Council 26.05.2003
OJ L 152 
20.06.2003on the approximation of the laws, regulations and administrative 
provisions of the Member States  relating to the advertising and 
sponsorship of tobacco products. 
Revision of the Tobacco 
Products Directive 
2001/37/EC concerning the 
manufacture, presentation 
and sale ongoing Substantial developments in  tobacco product regulation have 
taken place. Therefore, an update of the Directive is necessary 
in order to address Internal Market issues and respond to recent 
development (such as new forms of tobacco products and text / 
picture warnings). 
Only important basic legislation has been retained here, fo r the other legislation in relation with tobacco please 
see: http://ec.europa.eu/health /tobacco/law/index_en.htm 
 
ART. 168 AND 114 - PATIENTS' RIGHTS  IN CROSS BORDER HEALTH CARE  
Directive 2011/24/EU  09 March 2011 on the application of patients' rights in cross-border healthcare 
 
ART. 114 – PHARMACEUTICAL PRODUCTS 
Regulation EC/726/2004  of 
the European Parliament and of the Council 31.03.2004 laying down Community procedures for the authorisation and 
supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.  
Commission Regulation 
(EC) No 658/2007 14.06.2007 concerning financial penalties for infringement of certain 
obligations in connection with marketing authorisations granted 
under Regulation (EC) No 726/2004 of the European Parliament and of the Council 
Council Regulation 
EC/297/95   10.02.1995
OJ L 35, 
15.02.1995on fees payable to the European Agency for the Evaluation of 
Medicinal Products  
Commission Regulation (EC) No 1234/2008 24.11. 2008concerning the examination of variations to the terms of 
marketing authorisations for medicinal products for human use 
and veterinary medicinal products 
Directive 2001/83/EC of the European Parliament and of 
the Council 6.11.2001 on the Community code relating to medicinal products for 
human use 
 
Regulation (EC) No 
141/2000 of the European Parliament and of the 
Council 16.12.1999 on orphan medicinal products 
 
Regulation (EC) No 
1901/2006 of the European Parliament and of the 
Council  12.12.2006 on medicinal products for paediatric use and amending 
Regulation (EEC) No 1768/92, Di rective 2001/20/EC, Directive 
2001/83/EC and Regulation (EC) No 726/2004 
Regulation (EC) No 1394/2007 of the European Parliament and of the 
Council  13.11.2007 on advanced therapy medicinal products and amending 
Directive 2001/83/EC and regulation (EC) No 726/2004 
 88NUMBER DATE TITLE 
ART. 114 – PHARMACEUTICAL PRODUCTS 
Directive 2001/20/EC of the 
European Parliament and of 
the Council  04.04.2001 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  
Directive 2001/82/EC of the European Parliament and of 
the Council 06.11.2001 on the Community code relating to veterinary medicinal 
products 
Regulation (EC) No 470/2009 of the European 
Parliament and of the 
Council 06.05.2009 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 Dire ctive 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 
Revision of the Directive on 
clinical trials to foster clinical research and innovation in 
the pharmaceutical sector Ongoing The objective is to revise the Directive to address the 
shortcomings identified in previous evaluations conducted by the Commission in order to strengthen knowledge and 
innovation in clinical research. Issues likely to be addressed 
are: reduction of administrativ e delays, overcoming divergent 
decisions throughout the EU and streamlining of reporting 
procedures 
Proposal for a revision of 
the Directive on veterinary pharmaceutical legislation Ongoing The objective of the review is to increase the availability of 
medicines on the market, in particular to treat diseases of minor animal species or diseases occurring rarely. In addition, it aims 
at decreasing the burden on enterprises by streamlining the 
authorisation processes of veterinary medicines while respecting public health, animal health as well as the 
environment. 
Only important basic legislation has been retained here, for the other legislation in relation with pharmaceutical 
products, please see: 
HUMAN: http://ec.europa.eu/health/document s/eudralex/vol -1/index_en.htm  
      VETERINARY: http://ec.europa.eu/health/documen ts/eudralex/vol-5/index_en.htm  
 
 
ART. 114 – MEDICAL DEVICES 
Directive 90/385/EC of the European Parliament and of 
the Council 20.06.1990
OJ L 189
20.07.1990on the approximation of the laws of the Member States relating 
to active implantable medical devices 
Directive 93/42/EC of the European Parliament and of the Council 14.06.1993
OJ L 169
12.07.1993concerning medical devices 
Directive 98/79/EC of the 
European Parliament and of 
the Council 27.10.1998
OJ L 331
07.12.1998on in vitro diagnostic medical devices 
Directive 2007/47/EC of the 
European Parliament and of 
the Council 05.07.2010
OJ L 247
21.09.2007amending Council Directive 90/385/ EEC on the approximation 
of the laws of the Member States; relating to active implantable 
medical devices, Council Dire ctive 93/42/EEC concerning 
medical; devices and Directive 98/8/EC concerning the placing of biocidal products on the market 
 89NUMBER DATE TITLE 
ART. 114 – MEDICAL DEVICES 
Commission decision 
2010/227/EU 19.04.2010
OJ L 102
23.04.2010 on the European Databank on Medical Devices (Eudamed) 
Proposal for a Directive 
concerning medical devices and repealing Directives 
90/385/ECC and 93/42/ECC ongoing The objective is to simplify and strengthen the rules concerning 
medical devices in order to ensure a high level of health protection while ensuring the smooth functioning of the internal 
market and the competitiveness and innovation capacities of 
the sector. The current regime leads to a number of legal 
uncertainties regarding products falling outside any specific 
Union legislation. Moreover, it  is necessary to address some 
weaknesses in the system in particular as regards European 
coordination of the control of Notified Bodies. 
Directive concerning in vitro 
diagnostic medical devices and repealing Directive 
98/79/EC ongoing The objective is to simplify and strengthen the rules concerning 
medical devices in order to ensure a high level of health protection while ensuring the smooth functioning of the internal 
market and the competitiveness and innovation capacities of 
the sector. The current regime leads to a number of legal uncertainties regarding products falling outside any specific 
Union legislation. Moreover, it  is necessary to address some 
weaknesses in the system in particular as regards European coordination of the control of Notified Bodies. 
Only important basic legislation has been retained here, fo r the other legislation in relation with medical devices 
please see:  http://ec.europa.eu/health/medical-de vices/document s/index_en.htm   
 
 
  
 90ANNEX  7: CASE  STUDIES 
SUMMARY 
The following case studies have been developed by  the EAHC on the basis of its experience in 
monitoring actions financed under the 1st and 2nd Health Programmes. They have been chosen as 
representative of activities to be undertaken or conti nued in the framework of the Health for Growth 
Programme proposal (see table below). Each of th e case studies' action areas may serve more than one 
Programme objective, however, it is considered that there is always one focal objective where it can be 
related to. Their purpose is to illustrate the need  to equip the present programme proposal with an 
outcome-oriented structure and follow a pragmatic approach when defining specific objectives and 
indicators. Such an approach needs to analyze th e relevance of the health problem; to appraise the 
value of the programme's main and specific objectives and proposed areas of activities, in light of EU 
and Member States’ policies in  the area; to ensure that th e specific actions funded under the 
programme are geared to provide EU added value and impact; and thus, to demonstrate the logical 
framework of the programme action as a whole. 
As to the methodology of the case studies, it was centr ed on an analysis of the EU co-funded actions in 
the selected areas and covered two sets of broad questions:  
1. The relevance of EU funding in a given area was checked through a review of the following 
issues: (a). The health problem under scrutiny; (b). The objectives and means of EU policies/ 
actions in that specific area; (c). The member st ate action in the same area; (d). The EU added 
value of the co-funded actions. These questions re late to the policy relevance block of the 
award criteria and provide a good basis for appraisal of the relevance of a proposed action. 
2. The impact of EU funding in a given area wa s checked through a review of the following 
issues: (a). Review of activities, results and out puts; (b).Identification of target groups; (c). 
Analysis of project impact, both expected a nd achieved, with the help of valid "proxy" 
indicators (such indicators were not included ex ante); 
Finally, the case studies provide both a conclusion on the intervention logi c of the actions under 
review, as well as lessons learnt and co nsiderations for future improvement.  
 
Specific objectives Case studies 
1. develop common tools and mechanisms at EU 
level to address shortages of resources, both human and financial, a nd facilitate up-take of 
innovation in healthcare in order to contribute to 
innovate and sustainable health system  → HTA 
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 citizen → Pilot European Reference Networks on Rare 
Diseases/ possibility of extrapolation to non-rare disease networks → ORPHANET 
3. Develop shared guidelines for health care 
quality, transparency and patient safety → Cancer prevention and control, incl. cancer 
screening 
4. identify, disseminate and promote the up-take 
of validated best practices for cost-effective prevention measures, in particular by addressing the key risk factors, namely smoking, abuse of alcohol and obesity, in order to prevent diseases 
and promote good health → Supporting HIV/AIDS prevention 
5. develop common approaches and demonstrate → Reference laboratories for highly pathogenic 
 91their value for better preparedness and 
coordination in health emergencies in order to 
protect citizens from cross-border health treats agents 
→ SHIPSAN/ implementation of International 
Health regulations (IHR) 
Core-activities  
I. Health evidence  
II. Health legislation → Organ donations and tran splantation in Europe 
 92CASE STUDY N°1: Health Technology Assessment (HTA)  
 
Health problem under scrutiny 
° Improving cost-effectiveness of health systems is a ke y intervention area in order to ensure overall 
sustainability of health expenditure in an envi ronment of reduced resources and capital. In this 
framework, Health Technology Assessment (HTA) can , by identifying resource-effective, safe and 
effective interventions, provide health decision- makers with an evidence-based and transparent 
basis for decisions on the uptake and phase-out of health technologies, optimizing use of health 
budgets and providing best treatments to patients. 
° Evidence base for EU action:  HTA is an important tool but related resources, knowledge and 
expertise are unevenly spread in Europe.   
 
Objectives and means of EU policies/ action in the specific area 
Objective:  Provide a framework for collaboration in the area of HTA across Europe. 
Means of action:  
° Legislative action: article 15 of Directive 2011/24/EU, foresees the establishment of a voluntary 
network of bodies responsible for HTA. 
° Establish a regular, well-functioning European network linking HTA bodies in Member States 
with the following  specific objectives: 
¾ support cooperation between national authorities or bodies; 
¾ support Member States in the provision of objectiv e, reliable, timely, tr ansparent, comparable 
and transferable information on the relative efficacy as well as on the short- and long-term 
effectiveness, when app licable, of health technologies and to enable an effective exchange of 
this information between the national authorities or bodies; 
¾ support the analysis of the nature and type  of information that can be exchanged; 
¾ avoid duplication of assessments. 
 
MS action in the same area 
A majority of MS have designated bodies using HTA as a tool for the planning and development of 
their health services. However, the use of HTA di ffers greatly between countries. The EC action on 
HTA is clearly complementary to MS action since it aims to improve the interaction between these HTA bodies, establishing a common methodological platform and tools which will allow for more effective collaboration, task-sharing and re-use of HTA information. 
 
Aim of EU co-funded action(s) under evaluation 
° Development of a common methodological basi s for assessing health technologies (a so-called 
"core HTA model"), as well as tools for effective interaction and cooperation; 
° Exploration of  feasible working me thods for cooperative assessment work; 
° Development of common guidelines to streamline HT A requirements for health-related industries; 
° Reduction of the duplication of work in Member States through the re-use of core HTA 
information, that is of the common set of met hods and data that can be easily shared across 
borders; 
° Support to capacity building in Member States with limited resources on the use of HTA in their 
health decision-making processes; 
° Collecting of  long term and cross border data on the effectiveness of treatments, in view of 
supporting the development of personalised healthcare; 
 93° Increasing the capacity of stakeholders to be activel y part of the HTA process; particularly health 
professionals and patients' organisations. 
° Standardising requirements for the pharmaceutical in dustry being asked for additional clinical data 
from Member States, after market authorisation. 
 
EU added value 
Principal type of EU added value:  
° Economies of scale , insofar common methodological standards for the assessment of different 
health technologies lead to simplified sharing and re-use of HTA information  generated.  
° Economies of scale , insofar it contributes to a defragmentation of the decision-making processes  
regarding the uptake of new medicinal products and medical devices. 
Additional EU added value:  
° Promotion of best practice , insofar common methodologies developed within project become state 
of the art HTA tools to be used in natio nal/regional HTAs used for policy decisions. 
 
Activities (2006-2013) 
° Establishment of a European HTA network (EUn etHTA) and development of a generic "core 
HTA model" and related tools including adaptability to different technologies. 
° Testing of adapted versions of the "core HT A model" on selected methodologies (medicine and 
screening device), and development of tools for supporting and enlarging EU level cooperation. 
° Joint Action 2 on HTA (2012-2015); scaling up the num ber of pilots to gain better insights to 
feasible cooperation models in a regular, non-project setting, establishing scientific advice guidelines to health-related industries regarding th e data needs of HTA agencies, as well as doing 
training in Member States and for stakeholders on the use of the Core HTA model. 
 
Results/outputs 
° Development of a common methodological basi s for assessing health technologies (a so-called 
"core HTA model"), as well as adapted versions for a number of different health technologies. 
° Tools for enhancing cooperation across the EU, incl . web-based toolkit, information service and 
clearinghouse, capacity building activities, as well as  development of a ge neral strategy and a 
business model for sustainable European collaboration on HTA. 
° Application and field testing of  developed tools and methods. 
° Guidelines for scientific advice between HTA bodies and industry. 
 
Target groups 
Four are the main target groups of the work on HTA:  
° Participating HTA bodies : all HTA agencies/ bodies in the EU participate. 
° Healthcare industry and providers : HTA bodies interact with industry and more generally 
healthcare providers in order to perform their assessment. 
° EU and MS level policy makers : HTA is a key decision-making support tool for policy makers at 
the national, regional and local levels. 
° Users of health services : the decisions taken by policy makers and providers alike, on the basis of 
the HTAs will influence the availability of treat ments or interventions, incl. the cost element. 
 94Within these groups it is important to diffe rentiate between the following categories: 
° Potential (the wider community of experts, hea lthcare providers and industry, policy makers and 
users of health services/ technologies, whether targeted by the action or not) 
° Expected (those of the previous group expressly targeted by the activities of the pilot ERNs) 
° Reached (those of the previous group effectiv ely reached during the duration of the action). 
Impact can be strengthened ever y time we cross another level. 
 
Expected impact 
The nature of the actions so far implemente d (development and pilot testing of common 
methodological tools) argues for the following indicators (in growing order of importance): 
° Part of the HTA portfolio of activities covered by the common methodologies and tools : 
The "core model" can in principle be adapted to  a multitude of technologies and interventions, as per 
the adaptability toolkit; however, it is necessary to ha ve the data from the pilot testing to verify the 
validity of the methodologies and tools for this specific indicator.  
° Coverage of the target population , in terms of effective dissemination of the tools and 
methodologies: The participation of all the relevant  HTA bodies in the network is an indicator for 
high coverage, although uptake by the pa rticipants needs to be demonstrated. 
° Impact from the application of the available methodologies and tools: The availability of a 
commonly developed methodology and its adaptation to specific areas should lead to achievement of the set objectives, such as reduction of the dup lication of work and related economies of scale 
and/ or positive effect from EU-wide standardised  data and information requirements for industry. 
The same is valid for the positive effect expected  in terms of improving transparency and quality 
of decision making process for access to innovativ e health technologies across the EU. However, 
such gains, as well as the impact on HTA work at national level and consequences for health 
decision-making can only ensue after a sufficient number of pilots.  
° Sustainability and impact on the long term
 
Sustainability on the long term is ensured by  the Directive 2011/24/EU, which foresees the 
establishment of a voluntary network of bodies responsib le for HTA. However, the long term impact 
will depend on the level of uptake and commitment of the MS HTA bodies to make use of the common tools developed under the funded actions. 
 
Is it possible to differentiate the impact of EU funded actions under review from MS action? 
° The final decisions on the uptake and phase-out of health technologies remain with the MS; it is 
therefore not easy to determine the degree to which EU collaboration will guide the national level decision making process. However, the establishm ent of a formal EU-wide network on HTA to 
support the implementation of Directive 2011/24/EU will make this easier, as the use of the 
common tools can be directly linked to the ensuing decisions and their effects. 
° The impact of the current collaboration can also  be distinguished insofar it supports through 
capacity building activities, the MS with limite d experience in the use of HTA so far. 
 
Conclusion 
° The objectives, structure, activities and outputs of EU action in the field of HTA follow a clear 
and solid intervention logic  with, at least, a sufficient degree of expected impact. The real impact 
achieved can be assessed once a substantial number of joint HTA studies are completed. 
  
 95Other considerations for the future 
° An impact assessment of the EU action (to be done following the HTA JA2) should include a 
number of elements, such as: the resources nece ssary to jointly produce HTA studies; to what 
extent HTA information has been used at nati onal level with no/minimal adaptations; whether 
streamlining of industry HTA dossier requirements simplifies their work; etc.  
° A good example is provided by the early assessments of new pharmaceutical products45. Many MS 
use early single technology assessments, in fact ra ther "appraisals" than "assessments", since most 
of the evidence is already produced by the pharmaceu tical company. At an av erage cost of 20 000 
€, and with 15 MS making them in parallel, to tal costs would be 15 million € annually, 70 % of 
which concern clinical issues which can be shared at  EU level. If done in an EU context, the data 
could in addition be used in all remaining Member  States. One can add to those savings the costs 
for industry of providing adapted clinical data to  (often different or diverging) demands. Finally, 
European cooperation on these assessments could c ontribute to standardised requirements for 
industry which would increase transparency and pr edictability, with additional financial benefit.  
                                                 
45 Up to 50 such products are given Market Authorisation th rough the centralised EMA procedure in Europe annually, and 
Directive 89/105/EEC (the transparency directive) requires MS  to take a decision on prici ng and reimbursement of these 
products within 90/180 days.  
 
 96CASE STUDY 2: Pilot European Reference Netw orks (ERNs) in the area of Rare Diseases46 
 
Health problem under scrutiny 
° High overall burden of RD, in terms of significant morbidity, premature mortality, loss of Quality 
of Life (QoL), with extended impact beyond pa tients, to the socioeconom ic potential of family 
members (often acting as first line carers) and wider community, due to costly management. 
° Low prevalence, as well as low number of patient s by disease and per MS leads to large variance 
in access to diagnosis, to quality care and ultimat ely, to treatment, for lack of available 
information on and training about the diseases. 
° Evidence base of EU action:  the limited number of patients and scarcity of knowledge and 
expertise at MS level gives high poten tial added value to EU level action. 
 
Objectives and means of EU policies/ action in the specific area 
Objective:  Further improve the access and equity to pr evention, diagnosis and treatment for patients 
suffering from a rare disease throughout the EU. 
Means of action:  
° Legislative action: (a).Communication COM (2008) 679; (b).Council Recommendation (2009/C 
151/02); (c).Cross Border Health Care (CBH C) directive 2011/24EU (includes Rare Diseases 
under arts. 12 and 13).  
° Support the policies and initiatives of MS in th e following areas: recognition of RD; research; 
development of national plans and strate gies; knowledge production and dissemination; 
empowerment of patient organizations; setup of pilot European Reference Networks. 
 
MS action in the same area 
° National plans or strategies for RD exist in several MS and are in development in others; 
° Care pathways and collaboration within national h ealth systems with specialized units/ centres of 
expertise, incl. budgetary support; 
° MS support for RD specific registry work and funding for clinical research. 
 
Aim of EU co-funded action(s) under evaluation 
Several pilot reference networks ha ve been funded – although diverse, they share key characteristics, 
including main and specific objectives: 
Main objective:  
Share expertise and resources to improve the access a nd equity to prevention, diagnosis and treatment 
for patients suffering from the specific rare disease throughout the EU. 
Specific objectives:  
° Identifying expertise/ networking; 
° Sharing expertise for patient management; 
° Building up standards of care; 
                                                 
46 These networks, linking expert centres across Europe, have been  setup as pilots focusing on the special needs of the Rare 
Disease area, before the adoption of the CBHC Directive. Therefore, they should be  viewed an effort that can, through 
its specific experience, contribute to the Directive's future implementation, incl. through th e development of generic and 
not RD specific criteria for ERNs. 
 97° Improving clinical research 
 
EU added value 
Principal type of EU added value:  
° Generation/translation/validation/dissemin ation of knowledge and information. 
Additional EU added value:  
° Networking activities/ Development of  partnerships (involvement of national team of clinical and 
other experts) 
° Promotion of best practice (validated state-o f-the-art knowledge constitutes best practice)  
° Economies of scale (both for knowledge production and dissemination activities, as well as from 
promotion of quality standards for diagnosis, care and QoLife) 
 
Activities 
° Several such networks have been funded spanning both 1st and 2nd Community action 
Programmes. 
° Collection and validation of state-of-the-art information on the specific RD; 
° Set up of patients' registries for improving knowledge (natural history of the RD); 
° Development of collaborative tools for improvi ng quality of diagnosis, care or QoLife, incl. 
Quality Assurance scheme for labs, clinical  guidelines or central diagnostic capacities 
° Dissemination of information to healthcare prof essionals and patients, mainly through patient 
organisations when they exist. 
 
Results/outputs 
Analysis of networks previously and currently funded show that the most valuable resources 
developed by these pilot ERNs are: 
° Shared databases/ registries; 
° Shared tools for expertise in diagnosis and treatment, including tele-expertise; 
° Guidelines for clinical care and for biologi cal diagnosis and disease-specific information; 
° Training tools and sessions, both for hea lthcare professionals and patients; 
 
Target groups 
Two are the main target groups of the work of th e European Information networks on rare diseases:  
° Healthcare professionals and other experts in the areas related to the concerned RDs. The pilot 
ERNs provide validated quality knowledge, enablin g them to improve the Qof care they offer. 
° The RD patients (and families); The pilot ERNs  provide validated quality knowledge, enabling 
them to improve their life. 
Within these two groups it is important to di fferentiate between the following categories: 
° Potential (the wider community of healthcare professionals/ other experts and patients dealing 
with the specific RD, whether targeted by the action or not) 
° Expected (those of the previous group expressly targeted by the activities of the pilot ERNs) 
° Reached (those of the previous group effectiv ely reached during the duration of the action). 
 98Impact can be strengthened ever y time we cross another level. 
 
Expected impact 
Taking into account the nature of the action, i.e. co llection of information and development of shared 
tools for exchange of knowledge and expertise, the following indicators can be considered (in growing 
order of importance): 
° Part of the information available on the sp ecific RD currently covered by the network : 
This is in reality an output and not an impact  indicator. However, the scarcity of knowledge and 
resources in the RD area makes this a first necessary step. 
° Coverage of the target population,  in terms of effective dissemination of the available information 
and access to the shared tools, both for healthcar e professionals and other experts, as well as RD 
patients and their families (see section below). Impact can be measured by simple means, by comparing level of knowledge of target groups before and after the action. Expansion and 
outreach of the network can significantly increase exp ected impact, as is the case for some of them 
(Care-NMD). 
° Impact from the use of the available information and shared tools.
 
The availability of quality knowledge should l ead to improved quality of care (QoC) from the 
healthcare professionals in the field and improved QoL for the patients. 
There are several indirect ways to measure this: output indicators of quality could be defined when 
setting up these networks, based on interventions judg ed as landmarks of the QofC, or on changes 
in morbidity of morbidity judged as landmarks in QoL. Impact can also be measured by 
comparing levels of QoC and QoL before and af ter the action, for the network participants. 
However, the direct link of causality between the action and impact as regards the main objective 
(i.e. improve the access and equity to prevention, diagnosis and treatment for patients) outside the strict level of project participants is more difficult. Until now, it has been implied that the 
participation of highly specialized expert centres in the network ensures the uptake and use of the 
tools developed during the funding period. However, this needs to be demonstrated by appropriate 
indicators. 
° Sustainability and impact on the long term:
 
Sustainability of the network a nd continuous updating of the info rmation and tools developed in 
the initial phases are, together w ith the necessary outreach to ne w members, key elements for 
ensuring impact on the long term. 
 
Is it possible to differentiate the impact of EUfunded actions under review from MS action? 
° MS policies and strategies for RD (incl. desi gnation of centres) provide the necessary framework 
of action and funding for the centres of experti se making up the pilot ERNs. The activities of the 
networks come on top of the regular, clinical work these centres undertak e in the framework of 
their national health system. 
° The pilot ERNs develop the collaborative tools a nd resources that are conducive to the attainment 
of the common EU and MS objective, of improving the access and equity to prevention, diagnosis 
and treatment for RD patients throughout the EU. Therefore, action by MS and action at the EU 
level (co-funded by the HP) is complementary. 
° The contribution of the EU level collaborative work can be measured through the development 
cost of the collaborative tools/ procedures. Even though it has not been done, the impact can also be measured. 
 
Conclusion 
 99° The objectives, structure, activities and output s of the pilot ERNs follow clear and solid 
intervention logic  with, at least, a sufficient degree of expected impact. Continued funding in the 
future should incorporate impact indicators, in or der to demonstrate the contribution of the pilot 
ERNs in terms improving access and equity to prevention, diagnosis and treatment for RD 
patients.  
Other considerations for the future 
° The main caveat of funding such networks con cerns the question of sustainability: there are 
currently 5.000 recognized RDs and, until now, approx. 15 pilot ERNs have been funded. 
° The initial cost of investment for setting them up (approx. EU co-funding of 750.000€/ / pilot 
ERN for 3 years) is therefore prohibitive with little  chance to achieve meaningful coverage of the 
RD area under the current and future HP funding . On the other hand, the implementation of the 
Cross Border Health Care directive 2011/24EU will grant, in the future, legal recognition to such 
types of networks,. It is therefore important (a nd urgent) to look at alternative approaches in 
sharing of costs between MS and ensuring fundi ng both at the setup and maintenance phases. 
° Several possibilities exist, as shown by the award of  the Operating Grants funding to pilot ERNs 
since 2010, whereby costs are clearly split between hosting institutions (funded by MS) and the network itself. Additional approaches are: (a). The role of national (and EU) clinical research funding; (b). The role of industry, especially for the registries and databases; (c). Leveraging the role of existing knowledge hubs, such as ORPH ANET and EURORDIS, to provide "services for a 
fee", supporting the setup of new networks, with a much lower cost. 
 1001.1. CASES STUDY N°3; ORPHANET: The EU portal for rare diseases and orphan 
drugs  
 
Health problem under scrutiny 
° High overall burden of RD, in terms of significant mo rbidity, premature mortality, loss of Quality 
of Life (QoL), with extended impact beyond pa tients, to the socioeconomic potential of family 
members (often acting as first line carers) and wider community, due to costly management. 
° Low prevalence, as well as low number of patients by disease and per MS leads to large variance 
in access to diagnosis, to quality care and ultima tely, to treatment, for lack of available 
information on and training about the diseases. 
° Evidence base of EU action:  the limited number of patients and scarcity of knowledge and 
expertise at MS level gives high poten tial added value to EU level action. 
 
Objectives and means of EU policies/ action in the specific area 
Objective:  Further improve the access and equity to prev ention, diagnosis and treatment for patients 
suffering from a rare disease throughout the EU. 
Means of action:  
° Legislative action: (a). Communication CO M (2008) 679; (b).Council Recommendation (2009/C 
151/02); (c).Cross Border Health Care direc tive 2011/24EU (includes RD under arts. 12and 13).  
° Support the policies and initiatives of MS in th e following areas: recognition of RD; research; 
development of national plans and strate gies; knowledge production and dissemination; 
empowerment of patient organizations; setup of pilot European Reference Networks (ERNs). 
 
MS action in the same area 
° There is no national level database on RD such as ORPHANET (nor is there any other 
international level database); 
° National plans or strategies for RD exist in sever al MS and are in development in some others – 
they are a prime source for information contained in the dbase; 
° National teams of experts validate information for the dbase; 
° Information from ORPHANET is translated from EN to five MS languages by national teams/ 
funds (FR, DE, IT, ES, PT). 
 
Aim of EU co-funded action(s) under evaluation 
Main objective:  
The overall objective of ORPHANET is to serve as the reference portal and principal source of 
information dedicated to RD for European citizens and beyond.  
Specific objectives (covering more spec ifically, for the ORPHANET JA, 2010):  
° To provide an inventory of rare diseases organised to serve the needs in public health, in diagnosis 
and care and in research (ontology)  
° To produce high quality information on each ra re disease and ensure continuous updates; 
° To offer a directory of expert services in Europe  adapted to the needs of each MS and offer new 
ways to access and present the information;  
° To adapt the governance of ORPHANET and support tr ansition from a project structure based on 
a specific MS's infrastructure, to a truly EU in stitutional dimension, ensuring sustainability.  
 101 
EU added value 
Principal EU added value:  
° Generation/translation/validation/dissemination of knowledge and information despite scarcity of 
expertise at MS level. 
Additional EU added value:  
° Economies of scale (information is gathered, valid ated and disseminated centrally, at marginal 
cost for MS) 
° Promotion of best practice (validated state-o f-the-art knowledge constitutes best practice)  
° Networking activities/ Development of partnerships  (involvement of national team of experts) + 
Providing technical support, catalysing change and building sustainable institutional capacity 
(empowerment and capacity building within MS national teams). 
 
Activities (2011-2013) 
° Inventory of diseases:  Data collection of RD and of RD cl assifications, through published articles, 
books and reports from expert groups, as well as i ndexation of RD with pr evalence data, genes and 
clinical signs and cross-referencing with ICD 10, SnoMed-CT and MedDRA; Preparation of the 
next edition of ICD to be released in 2014  
° RD Encyclopaedia:  Updating of summary information for 2,400 new and updated abstracts/ year. 
° Translation  of the inventory of diseases and summary in formation into French, German, Italian, 
Spanish and Portuguese. Other languages are in preparation (Dutch/Flemish; Polish) 
° Directory of services : Data collection on expert clinics, medical laboratory activities, networks, 
registries, research activities, clinical trials, orphan designations, marketed drugs and patient 
organisations in the participating countries. 
° Development of customised websites by country in national language(s). 
° Production of review articles (50/ year) in  the Orphanet Journal of Rare Diseases. 
° Publication of national and international clin ical guidelines and patient information packages 
 
Results/outputs 
° A reference source of information on RD for Eur opean citizens and professionals, contributing to 
optimal diagnosis and management of th ese severe, chronic and debilitating diseases. 
° Coverage of all of the almost 6,000 rare diseas es in at least six languages (and maybe more if 
additional funding is identified at MS level. 
° A directory of expert services as defined by MS, in order to access the appropriate care pathways, 
coupled with a web tool for policy makers and hea lthcare managers to disse minate the information 
on the services and on the clinical guidelines they wish to promote. 
 
Target groups 
Three are the main target groups of ORPHANET:  
° Healthcare professionals and other experts in the areas related to the concerned RDs. ORPHANET 
provides validated quality knowledge, enabling them  to improve the Qof care (or research, lab 
testing, etc) they offer. 
° The RD patients (and families); ORPHANET provi des validated quality knowledge to empower 
them to improve their Qof life. 
 102° Policy makers at EU and MS leve l are provided with views on the public health impact of rare 
diseases and on the healthcare services available in Europe. 
Within these three groups it is important to differentiate between the following categories: 
° Potential (the wider community of healthcare prof essionals/ experts active in the area of RD, all 
the patients and family members, all policy makers ). As a comprehensive global reference portal 
of information, ORPHANET has the ambition to  reach out to the entire potential target 
population) 
° Expected (those of the previous group expr essly targeted by the activities of ORPHANET) 
In this case, we have  
° Reached (those of the previous group effectiv ely reached during the duration of the action). 
Coverage of the target population  
° It is estimated that today in the EU, 5-8000 distinct  rare diseases affect 6-8% of the population, i.e 
between 27 and 36 million people. ORPHANET h as 20.000 hits/ daily, or 73 Million/ year. 
 
Expected impact 
Taking into account the nature of the action, i.e. production and dissemination of knowledge, the 
following indicators can be considered (in growing order of importance): 
° Part of the information available on RD currently covered by the dbase : 
This is in reality an output and not an impact  indicator. However, the scarcity of knowledge and 
resources in the RD area makes this a first necessary step. 
ORPHANET ranks highly on this criterion. As it is the reference information portal worldwide, 
coverage is comprehensive, including all rare diseases.  
° Coverage of the target population , in terms of effective dissemination of the available information, 
both for healthcare professionals/ experts, as well as RD patients and their families (see section 
below). Impact can be measured by simple means,  by comparing level of access to information 
packages of target groups, the expansion of target  groups before and after the action and to their 
expressed satisfaction through online surveys. Expansion and outreach of the dbase can significantly increase expected impact. Measurement  of use of the dbase, incl. steady increase in 
hits shows very extensive dissemination, as also does the interest of countries outside the EU to 
join and self-fund their participation. 
° Impact from the use of the available information.
 
The availability of quality knowledge should lead  to improved quality of care (QoC) (or other 
outcomes, research, etc.) for the healthcare professi onals/ experts in the field and improved QoL for 
the patients. There are several indirect ways to meas ure this: by comparing levels of implications of 
MS in the production/adaptation/translation of clinical guidelines; of the use of the Orphanet nomenclature in the health information systems of  the participating countries; of the use of the 
Orphanet data for public health and research studies; by considering the trends with time in number of 
uses of each of the proposed services. 
However, the direct link of causality between the act ion and impact as regards the main objective (i.e. 
improve the access and equity to prevention, diagnosis  and treatment for patients) is more difficult to 
establish. Until now, it has been implied that the base corresponds to the needs of the target groups and 
therefore, access to the information contained in ORPHANET (notably by highly specialized experts) 
will lead to its use and therefore better outcomes.  However, this needs to be demonstrated by 
appropriate indicators. 
° Sustainability and impact on the long term
 
 103Sustainability of the dbase depends not only on renewe d funding, but also in ensuring current levels 
and quality of coverage in the future, while also adap ting to emerging trends in IT in general/ in the 
specific knowledge area and to EU and MS health policies in the RD field. 
 
Is it possible to differentiate the impact of EU funded actions under review from MS action? 
° Until today, efforts for information gathering a nd data validation are ORPHANET driven and not 
MS driven. 
° The initial and continuing investment by FR (through the support to the main beneficiary 
INSERM), needs to be highlighted – this initial inv estment and cost has the advantage to lower the 
necessary investment that individual MS need to  provide for offering to their citizens a high 
quality information in the national language(s).  
 
Conclusion 
° The objectives, structure, activities and out puts of the ORPHANET follow clear and solid 
intervention logic  with, at least, a sufficient degree of expected impact. 
° Coverage of the target population is comprehensive, while the database also covers the totality of 
the knowledge area, being today the worldwide refere nce in the field. Use of the database is very 
high and steadily increasing, as also does the interest  of countries outside the EU to join and self-
fund their participation.  
° Funding in the future should incorporate imp act indicators, in order to demonstrate the 
contribution of the use of knowledge produced by ORPHANET in improving access and equity to prevention, diagnosis and treatment for RD patients. 
 
Other considerations for the future 
° Sustainability will be ensured by transformi ng the operational framework and governance of 
ORPHANET into a truly EU institutional dimension,  to also include adequate funding component. 
 104CASE STUDY N°4: Projects in the area of cancer  prevention and control, incl. cancer screening  
 
Health problem under scrutiny 
° Cancer is the second cause of death in the EU. Sc ientific insights developed over the past decades 
on specific factors that can lower mortality, demonstrate the value of well designed and 
implemented large-scale prevention and cancer control activities. 
 
Objectives and means of EU policies/ action in the specific area 
Objective:  contribute to the reduction of cancer burden in the EU by supporting the Member States in 
their efforts to tackle cancer by: (a). Pr oviding a framework for identifying and sharing 
information, capacity and expertise in cancer pr evention and control, and (b). Engaging relevant 
stakeholders across the European  Union in a collective effort. 
Means of action:  
° Legislative action: (a). Communication COM (2009)  291/4, which encompasses previous texts in 
an updated policy framework47. 
° Support the policies and initiatives of MS in the following areas: Prevention, as the most cost-
effective response; Applying best healthcar e approaches in practice - identification and 
dissemination of good practice; Cooperation and co ordination in cancer research; Benchmarking 
process – providing the comparable information necessary for policy and action 
 
MS action in the same area 
Each MS has developed a specific action plan agai nst cancer. The EU action against cancer is clearly 
complementary to MS action since it is supposed to concentrate knowledge and means where economies of scale are likely; to further dissemina te good practices; and to provide a framework for 
identifying and sharing informati on, capacity and expertise in can cer prevention and control, to 
include benchmarking across the EU MS or regions.  
Aim of EU co-funded action(s) under evaluation 
As mentioned, several actions have been funded in the area of cancer, starting before the adoption of 
the 1st and 2nd health programmes – although diverse, they share key characteristics: 
Main objective:  
Working together on a European level to preven t and control cancer more effectively and reduce 
inequalities in cancer incidence and mortality. 
Specific objectives:  
The activities developed by the different  actions have been very diverse.  In light of the objective of the 
present case study, it is more relevant to review th e specific objectives of the 2010 Joint Action, which 
completes and summarizes past actions: 
° The building up of a guideline for National Cancer Plan to support integrated and coordinated 
cancer measures in the MS. 
° Raising awareness about cancer prevention among targeted groups 
° To improve cancer screening and early detection in EU 
° To identify, assess and exchange best practices in cancer care across the EU 
                                                 
47 Council Recommendation 2003/ 878EC;  Council Conclusions of 10/06/2008;  Commission Communication 2009/291  
 105° To develop a concerted and coordinated approach for one third of all funding sources dedicated to 
cancer research. 
° To identify areas of data availability and needs in order to get better cancer burden indicators 
(incidence, mortality, survival and prevalence) across EU. 
 
EU added value 
Principal EU added value:  
° Economies of scale through the concentration of knowledge and skills: evidence based guidelines 
for screening are prepared once for all and can be taken up by all MS; the same is valid for the 
guidelines for preparing a high level standard NCP. 
° Economies of scale related to aw areness raising actions all acros s EU are likely as well. Finally 
the concentration of funding for research is expect ed to produce not only economies of scale, but 
also a clear leveraging effect. 
Additional EU added value:  
° Promotion of best practices : for screening and early diagnosis, for National Cancer Plans 
development and for cancer care.  
° Availability of good data/ information should lead to benchmarking for decision-making . 
However as a general rule, the link between data  comparison and decision-making still needs to be 
demonstrated.  
° Finally, any action putting together all stakeholders at such a large scale is expected to bring added 
value through networking , as a clearly beneficial additional side effect. 
 
Activities (2003-2013) 
° Several such actions have been funded spanning both 1st and 2nd Community action Programmes. 
° Development of screening guidelines: it has been the case for colorectal and breast cancers or/and 
screening promotion as for example cervical cancer. 
° Standardisation of data collection: collaborati on, networking and standardisation for patients' 
registries and data collection, including fight against inequalities in cancer care. 
° Support to raising awareness: through conferences  and dissemination of general information on 
cancer, through support of health promotion activities such as the week against cancer. 
 
Results/outputs 
° Edition of evidence based screening guidelin es for colorectal and breast cancers.  
° Support of EU-wide promotion/prevention activities: European week against cancer, EU code 
against cancer, AURORA project for screening of cervical cancer, EPIDERM project for skin 
cancers, conferences such as Europa Donna Breast cancer, ECPC cancer summit, etc. 
° Support of cancer network and among others towards new MS. 
° Standardisation of data in relation with the European Community Health Indicators system. 
° Support of the European Network of Cancer Registries 
 
Target groups 
Three are three main target groups of actions funded in the area of cancer:  
° Policy makers at EU and MS level are provi ded with evidence-based tools (such as the 
guidelines), enabling the latter for example, to improve their national prevention programmes. 
 106° Healthcare professionals are also specifically target ed, through the sharing of expertise and data. 
° The EU citizens, those already affected by the di sease, as well as those that may be in the future. 
Within these groups it is important to diffe rentiate between the following categories: 
° Potential (the wider community of healthcare professionals/ experts active in the area, all the 
patients and family members, all policy makers). 
° Expected (those of the previous group ex pressly targeted by the funded activities). 
° Reached (those of the previous group effectiv ely reached during the duration of the action). 
 
Expected impact 
° The impact of screening related actions  can be demonstrated by the uptake of the guidelines  by the 
MS, a clear positive result at the level of the polic y makers target group. It is more difficult to 
evaluate impact on health professionals because use of guidelines greatly depends on MS policy. 
This causality link is even more difficult to estab lish at the level of the population target group. 
° The impact of standardised data collection  is clear with regards to the development of the 
European cancer registries network; data are ess ential for health policy in general and quality of 
care policy in particular. Here also the impact is mainly at the level of policy makers. 
° Impact of raising awareness  is likely when a European campaign is organised at the EU level and 
has the whole population as a target group. The assessment of this impact is by far more difficult. 
 
Is it possible to differentiate the impact of EU funded actions under review from MS action? 
° The impact of the first programmes against cancer (1985 – 2000)  has been evaluated via a study in 
term of mortality reduction (10%) compared to a pre-defined strategic objective (15%). This 
impact assessment was oriented towards the popula tion at large as target group, but it has several 
weaknesses, including: the difficulty to demonstr ate the exact role of the programme in the 
mortality decrease observed; the difficulty to differe ntiate the action at EU level and the action at 
MS level. 
 
Conclusion 
° The objectives, structure, activities and outputs of th e projects in the area of cancer follow a clear 
and solid intervention logic  with, at least, a sufficient degree of expected impact. The structure of 
the current EPAAC JA provides a cohere nt framework for future action.  
° Funding in the future should incorporate imp act indicators, in order to demonstrate the 
contribution of specific actions to the reduction of the burden of cancer in the EU. 
 
Other considerations for the future 
The impact of EU action against cancer is not easy to assess: the evidence base of several actions is 
not so clearly demonstrated and it is difficult to di fferentiate the impact of EU level actions vis a vis 
MS action. However the following methods/ indicato rs can be considered for assessing impact of 
future actions: 
° Screening guidelines:  computation of economies of scale by  doing one set of Evidence Based 
guidelines instead of 27. 
° Screening guidelines:  increased population reached by screeni ng activities in the EU. The impact 
of the EU action could be identified by, for exam ple, benchmarking countries that have introduced 
the guidelines in their screening activities, vis a vis those that have not. Additionally, some 
specific studies could be launched on the impact of the MS activities on the screening population 
in order to better identify the specific imp act and added value of the EU programme. 
 107° Impact of awareness raising activities on the cancer burden  has to be demonstrated for example by 
literature systematic review or specific study and the impact of EU action should then be clearly 
demonstrated in relation with MS actions. 
° For indicators and registries : impact on the decision making process should be demonstrated first 
(how does an indicator actually influen ce the political decision making process?). 
° Impact of National Cancer Plans : a clear link between a "state of the art" plan and impact on 
cancer care and/or prevention has to be demonstrat ed for example by systematic literature review 
on published impacts or a specific data study. 
° For research : economies of scale due to the regrouping of  funding (or leveraging effect) can be 
demonstrated; impact on cancer burden has probably to be measured at vari ous levels (Quality of 
life, survival, incidence, progression of impact in different population, links between screening 
and access to care in low capacity health systems). 
 Breast cancer is a very good example of how to structure the activities of  the present programme 
proposal to maximize impact:  
There is a body of evidence demonstrating that screening for women between 49 and 70 years is an 
effective method for prevention and control of cancer. The way screening has to be organised is put in 
a guideline after systematic review of the sci entific literature. The guideline includes a clear 
description of the training and quality control activities. 
The production of the guidelines in a single, joint effort presents indisputable EU added value. 
However, this activity does not by itself ensure im pact – this requires activities to disseminate the 
guidelines across the EU; ensure uptake by the MS ; monitoring the development and implementation 
of screening programmes at different levels (nat ional, regional); measuring the effects of the 
implementation f the screening programmes. 
If these activities are carried out, then impact could be assessed by: 
√ Measuring the level of dissemination of the guidelines among MS. 
√ Measuring the uptake of the guidelines by MS  including regional and local levels. 
√ Measuring the coverage of the target population involved in screening activities (percentage of 
women participating in screening activities among all 49-70 years old women in the EU on the 
basis of a good standardized registration of this indicator).  
√ Measuring the decrease of lead time before diagnos is and decrease of mortality as endpoint of the 
assessment, taking into account the other factors having an impact on these indicators.  
√ Comparison of MS with good uptake and MS with  weak uptake to assess the specific role of EU 
action, taking into account the differences in th e organisation of the screening activities in the MS 
under comparison. 
 
 108CASE STUDY N°5: Supporting HIV/AIDS prevention in Europe  
 
Health problem under scrutiny 
° HIV/ AIDS infection remains of major public hea lth importance in the EU/EEA; not only is there 
no cure or preventive vaccine for HIV infections, but  new infections are increasing at particularly 
alarming rates in Eastern Europe, while un-diagnosis  and late diagnosis of  patients is frequent, 
with serious consequences. 
° Evidence base for EU action:  the differences in rates of infections between MS and the threat that 
this poses due to the free movement of persons , argue for collaborative work on evidence based 
methods to support prevention and stop the transmission of the infection. 
 
Objectives and means of EU policies/ action in the specific area 
Objective:  To support actions for the prevention of HI V/AIDS and reduce the burden of the disease. 
Means of action:  
° Legislative action: (a). Commission Communica tion 569/2009 "Combating HIV/AIDS in the 
European Union and neighbouring countries, 2009-2013 serves as framework to support national strategy developments and steers HIV policy coor dination between EU countries; (b). Commission 
Decision No 2119/98/EC setting up the epidemiologi cal surveillance and control of communicable 
diseases, with sexually transmitted diseases included in the annex I)
48; (c). Additional existing 
political commitments to improve HIV/AIDS prev ention as e.g. expressed in the Dublin, Vilnius 
(2004) and Bremen ministerial declarations (2007).  
° Support MS activities in HIV/AIDS prevention, as well as in improving quality and access of 
health services, including testing for HIV and co-i nfections and treatment and care, especially for 
vulnerable groups. 
  
MS action in the same area 
° Several if not all MS have a strategy or an action plan in the area of HIV/AIDS prevention; 
moreover, MS have the advantage of controlling all the policy "levers" to ensure effective 
prevention and access to diagnosis and treatment for vulnerable groups, including social services, 
access to the competencies and services of local au thorities, skills of the informal sectors (NGOs, 
volunteers, etc). The concrete organisation and implementation of these plans depends on the MS 
authorities; moreover, the MS have also undertaken specific individual engagements, alongside those of the EC (see above). 
 
Aim of EU co-funded action(s) under evaluation 
The EU health Programme has funded more than 60 actions to tackle the HIV/AIDS epidemic in 
Europe and Neighbourhood countries, mainly focused on prevention activities. 
The same strategic aim, i.e. re ducing the burden of the disease by improving HIV/AIDS prevention in 
Europe, will be the subject of a Joint action (pla nned under the 2012 Work Plan, to be lead by the 
German Ministry of Health), with a particular focus on the following areas: ,  
                                                 
48 Additional texts with relevance to HIV/AIDS: Decision No 1150/2007/EC establishing the Programme ‘Drug prevention 
and information’ 2007-2013 having as one of the general objec tives to prevent and reduce drug use, dependence and drug-
related harm; Communication COM/2009/0567 ‘Solidarity in heal th: reducing health inequalities in the EU, addressing 
health inequalities in the Member States as well as the questio n of disparities in life expectancy, especially for vulnerable 
groups. 
 
 109- To promote the integration of quality assurance (Q A) and quality improvement (QI) practices into 
HIV/AIDS prevention programmes (by development of methodologies and tools for QA/QI in 
HIV prevention);  
- To support the implementation of interventions ta rgeting key priority groups, by developing key 
evidence based projects promoting tes ting and universal access to treatment. 
 
EU added value 
Principal type of EU added value:  
° Free movement of persons  is relevant to the spread of HIV/ AIDS, while in Eastern European MS 
infections are often accompanied by a high degree of co-infections such as (multi-drug resistant) 
tuberculosis or hepatitis B and C. 
Additional EU added value:  
° Several instruments are established for defi ning benchmarking to support decision making , like 
the existing European surveillance networks for HIV/AIDS, STI and TB and the 2010 progress 
report on implementation of the Dublin declaration.   
° Networking : actions funded under the Health Progr amme funding have established expert 
networks, bringing together P ublic health authorities, civil society organisation and academic 
organisations.  
° Exchange of best practice : provided by sharing validated prevention methods to reach vulnerable 
groups.  
 
Activities 
As mentioned before, the EU health Programme ha s funded more than 60actions to tackle the HIV 
epidemic in Europe and Neighbourhood countries,  including actions focusing on improving quality 
and access of health services, including testing for HIV and co-infections and treatment and care, for 
vulnerable groups49 
 
Results/outputs 
° Setup of several specialized networks on HIV/ AIDS prevention, with a special focus on 
vulnerable groups. 
° Capacity building activities for health profession als and civil society organisation, in the 
promotion of HIV/AIDS voluntary, counselling and testing and universal access to HIV/AIDS 
treatment, and co-infections (hepatitis and tuberculosis).  
° Exchange of good practises in the different are as of promotion, prevention, access to care and 
treatment. 
 
Target groups 
Two are the main target groups of actions funded in the area of HIV/AIDS prevention:  
° Persons living with HIV/AIDS and their relatives,  with a special focus towards vulnerable groups, 
belonging to the social excluded populat ion groups, ethnic and sexual minorities.  
                                                 
49 (a). ENCAP project  on HIV/AIDS prevention among Intravenous Dr ug Users in the Baltic countries; (b). ACTIVATE  
(capacity building and Training project in HIV/AIDS  Treatment and manageme nt across Europe; (c). SIALON Network  on 
combined and targeted prevention on MSM population; (d). EATG  in promoting the availabili ty and accessibility of HIV 
treatment and care and/or affordable cost of HIV treatment across Europe; (e). Correlation network  to improve prevention, 
care and treatment services among vulnerable and high risk populations (e.g . drug users, young people at risk); (f). The 
Eurosupport network , aiming to prevent HIV/AIDS and other sexually transmitted infections by supporting delivery of 
services on sexual and reproductive health (SRH) . 
 110° Health care and social welfare professionals, as fi rst line carers and support for those affected by 
the disease, as well as civil society organisati ons who are active on HIV/AIDS prevention. 
Within these two groups it is important to di fferentiate between the following categories: 
° Potential (the wider community of healthcare professionals/ experts active in the area, all the 
patients and family members). 
° Expected (those of the previous group ex pressly targeted by the funded activities) 
° Reached (those of the previous group effectiv ely reached during the duration of the action). 
 
Expected impact 
The nature of the actions so far implemented (development, implementation and dissemination of 
validated prevention methods and other interventions) argues for the following indicators (in 
growing order of importance): 
° To which degree the tools and interventions deve loped cover well defined thematic fields or 
geographical areas on HIV/AIDS prevention: alth ough numerous, the individual projects have a 
very restricted thematic or geographical focus,  leading to an overall very fragmented approach 
(with the exception of SIALON project).  
° Coverage of the target population , in terms of effective dissemination of the tools and 
interventions: such dissemination is extensive w ithin the networks funded, but there is no 
structured methodology for reaching stakeholders outside the project groups. Moreover, uptake by 
the participating partners needs to be demonstrated. 
° Impact from the implementation of the available tools and interventions: the availability of a 
validated intervention, whether in prevention or access to care, should lead to the achievement of 
the set objectives, such as the reduction of the burden of the disease and/ or the improvement of prevention. However, it is difficult to establish th e causality link between the implementation of an 
intervention within a project setting and its impact.  
° Sustainability and impact on the long term
 
The HIV/IDS actions on prevention suffered a major li mitation due to the lack of European dimension, 
mostly conditioned by the availability of resources,  limiting the involvement of specific organisations, 
from some cities/countries and not allowing a genera lised intervention. Addiitionally, targeting the 
most vulnerable groups with effective prevention me ans ensuring that the actio n has a sufficient length 
of time to ensure impact. 
  
Is it possible to differentiate the impact of EU funded actions under review from MS action? 
° The European MS are committed to tackling HIV/ AIDS in Europe, as they have supported the 
establishment of extensive European networks and the co-funding of the Health Programme 
actions, for the implementation of effective pr evention policies. However, it is difficult to 
currently establish the degree to which the tools and interventions developed under the EU funded 
projects have found their way into the national actions on HIV/AIDS. 
° The specific focus on the upcoming Joint Ac tion on quality assurance (QA) and quality 
improvement (QI) practices into HIV/AIDS prevention programmes may remedy this situation 
insofar as he participating MS to this JA commit to integrate such quality attributes and measure in 
their national actions. 
 
Conclusion 
° Several projects in the area of HIV/AIDS may be stru ctured so as to ensure impact in their specific 
context and in line with the main and specific obj ectives which they have set to achieve. Such, is 
for example, the case of SIALON, where the project  has succeeded in reach ing a very significant 
 111part of its target population and where the tools used have been identified as a good practice in the 
area of prevention. 
° However, the same cannot be said of the entire por tfolio of projects in the specific area - the 
problem does not lie with the specific projects, but with the lack of focus on one or two specific 
areas where a difference can be made and to whic h adequate resources shoul d then be addressed.  
 
Other considerations for the future 
° The potential of tackling HIV/AIDS and its co-infecti ons in Europe is high. Additionally, there is 
sufficient evidence of effective methods to stop th e transmission of the infection and Europe has 
the expertise developed after more than 30 year s of public health programmes and policies. 
° However, the present programme proposal should pr ioritize actions to one or two specific areas 
where a difference can be made because of the collaboration at the EU level  and to which 
adequate resources should then be addressed. There are especially some potent "quick wins": for 
example eradication of mother-to-child transmi ssion (MTCT) in Europe can be achieved with 
relatively low investments on antenatal screening a nd effective treatment of pregnant women and 
newborns, independent of their social status or if they belong to an ethnic minority group. The 
same is valid for HIV/AIDS te sting and HAART treatment, which is an effective prevention 
means to reduce transmission of the infection onwards, limiting the disease burden and producing 
savings by averting new HIV/AIDS cases. 
 112CASE STUDY N°6: Reference Laboratories for highly pathogenic agents (JA QUANDHIP)50 
 
Health problem under scrutiny 
° Europe is facing continuous thr eats related to emergent communication diseases, with natural or 
intentional release as illustrated by several events caused by highly pathogenic agents in the recent 
past (H5N1, Marburg, Chikungunya, Lassa fever, C.difficile 027, H1N1, E. coli, etc.) in recent 
years. Such threats will, by definition not stop at borders and preparedness and response depends 
on timely and accurate identification of the specific agent.  
° Evidence base for EU action:  The laboratory preparedness among EU MS is heterogeneous, with 
some laboratories using well-established methods fo r identification of highly pathogenic bacteria 
and virus (Bio-safety group 3 and 4). 
 
Objectives and means of EU policies/ action in the specific area 
Objective:  Ensure quality diagnostic capacity in order to  provide the scientific evidence for response 
at the level of the European frontline responders: health care professionals, security officers and 
forensic experts.  
Means of action:  
° Legislative action:  
¾ Commission Decision No 2119/98/EC setting up the epidemiological surveillance and control 
of communicable diseases.  
¾ Commission Communication (2009)0273on Strengthening Chemical, Biological, Radiological 
and Nuclear Security in the European Union - an EU CBRN Action Plan 
¾ International Health Regulations (IHR) 2005 requiring MS to assess and develop core 
capacities to meet their requirements in  relation to surveillance and response 
° To support the MS capacity to identify and resp ond to threats and foster necessary cross-border 
collaboration with national European , and International organisations. 
 
MS action in the same area 
MS have the responsibility for national laboratories;  they have also developed national plans for 
preparedness and response, as well as Quality Assura nce schemes for national laboratories. However, 
the cost of setting up and ensuring required diagnostic quality for such laboratories is very high, while 
not all MS have the same technical capacity. 
 
Aim of EU co-funded action(s) under evaluation 
QUANDHIP will perform European Quality Assurance Exercises (EQAEs) for bacteria and viruses, 
including antimicrobial susceptibility test for bacteria ; extend the repository for bacteria and virus;  
improve the existing checklists for laboratory infr astructure, containment, and operational bio-safety 
and bio-security; and develop sta ndards operating procedures to suppor t the coordination of response 
to cross-border highly infectious pathogens events. 
EU added value 
Principal type of EU added value:  
                                                 
50 Establishment of the Quality Assurance Exercises and Ne tworking on the Detection of Highly Infectious Pathogens 
(QUANDHIP) Joint action, which is an innovative initiative brid ging frontline responders and th e specialised (ENP4Lab) and 
(EQADeBa) networks, involving 33 laboratories from 21 EU MS.  
 
 113° Economies of scale : the development of the European la boratories of reference network with 
individual laboratories covering more than one MS has increased the return on investment, while 
the cost of creating such highly specialised laboratories at individual EU MS was prohibitive.  
Additional EU added value:  
° Promotion of best practice:  insofar the check list on bio-safety and bio-security and the quality of 
laboratory diagnostic methodologi es developed under the EU network conforms to "best 
laboratory practice" standards. 
° This is an internationally recognised initiative, strengthening the EU as an effective actor in the 
Global Health security initiative, particular ly on laboratory preparedness (GHSAG -LN). 
 
Activities 
QUANDHIP JA builds on previous leve ls of collaboration, as follows: 
° The EQADeBa project (Establishment of Quality  assurances for detection of highly pathogenic 
bacteria of potential bioterrorism risk), de veloped the validation and improvement of the 
diagnostic capacities for bacteria based threats (risk group 3).  
° The ENP4 Lab project (European Network of P4 Laboratories) enhanced the European 
preparedness for the detection of emerging virus based threats (risk Group 4).  
 
Results/outputs 
QUANDHIP JA, builds on previous leve ls of collaboration, as follows: 
° EQADeBa project delivered: the establishment of  a repository of quality-controlled reference 
samples of high-threat bacteria;  the performance  of three External quality assurance exercises; 
and the development of training programme for laboratory assurance of quality, bio-safety and 
bio-security  
° ENP4 Lab project delivered: the inventory of EU P4 Laboratories capabilities, including the 
agents of expertise; the development of check  list for performing Bio-safety and Bio-security 
audits; the standardisation of Group 4 agents’ diagnostics  through quality assurance exercises; 
and the elaboration of a Mobile laboratory feasibility study report 
QUANDHIP JA will continue these efforts to: 
° Perform external quality assurance exercises (proficiency testing) for highly pathogenic agents 
group 3 and 4; 
° Develop bio-safety and bio-security  check list used for the auditing of the laboratories; and 
° provide a feasibility study of the Mobile laborat ories, applied by Instrument of Stability from 
DEVCO. 
 
Target groups 
Three are the main target groups: 
° MS authorities, with responsibility in implementi ng health protection policies and procedures and 
more specifically the laboratories themselves as ke y actors for the organization of the response. 
° Laboratory workers dealing with high threat pat hogens, frontline health care workers and forensic 
responders, bio safety experts, transport carriers of biologically dangerous goods, other categories 
with occupational risk.  
° European citizens in case of event of natural out breaks and non-natural release of highly infectious 
pathogens.   
Within these three groups it is important to differentiate between the following categories: 
 114° Potential (the wider community of healthcare prof essionals/ other experts, MS authorities and EU 
citizens that may be affected by an event as described above) 
° Expected (those of the previous group expressly targeted by the activities of the actions under 
review) 
° Reached (those of the previous group effectiv ely reached during the duration of the action). 
Impact can be strengthened ever y time we cross another level. 
 
Expected impact 
The potential impact on public health is high, as most of the BSL3 and BSL4 are highly pathogenic, 
causing high morbidity and mortality. Taking into account  the nature of the action, i.e. EQAE for P3 
and P4 laboratories, the following indicators can be considered (in growi ng order of importance): 
° Part of the area of diagnostic capacity for highl y pathogenic agents effectively covered by the 
actions: building on EQADeBa and ENP4 Lab projects, QUANDHIP covers the entire field.  
° Coverage of the target population in term s of effective dissemination of the results : the actions 
under review bring together (i.e. cover) all the laboratories which would be required at the EU 
level to identify the pathogenic agents in question and are at the root of the response systems, 
while also engaging the relevant MS authorities. 
° Impact from the use of the available tools: the impact of the EQAE on the performance of the 
participating labs is very high, as the capacity of detection for highly pathogenic bacteria has 
improved significantly, from 62.6% to 92%, from 2006-2009.  
° In principle, such performance should also positivel y affect the level of impact to the European 
frontline responders; to other categories with occ upational risk; as well as to the EU citizens at 
large. However, this can only be substantiated in the case of an outbreak – even though modelling/ 
forecasting exercises could quantify the positive effect  of high quality and rapid diagnosis of a 
highly pathogenic agent in reducing the impact of  an outbreak. Sustainability and impact on the 
long term:  
Sustainability of the network and continuous qua lity assurance and control measures need to be 
ensured.  
Is it possible to differentiate the impact of EU funded actions under review from MS action? 
° It is, simply because the actions under evaluation lead to sharing of diagnostic capacity between 
MS, which would not have happened without  the contribution of EU funded actions. 
 
Conclusion 
° The objectives, structure, activities and outputs of EU action in the field of reference laboratories 
for diagnostic support towards preparedness and r esponse to health threats emanating from highly 
pathogenic agents follow a clear and solid intervention logic  with, at least, a sufficient degree of 
expected impact. 
° The creation of a network of reference laboratori es improves detection capability in general across 
the EU, by the standardisation of methods, by  fostering collaboration, through exchange of 
knowledge, training, and development of scientific evidence. 
 
Other considerations for the future 
N/A
 115CASE STUDY N°7: Support the acquisition of the core capacities for the implementation of the 
International Health regulation (IHR 2005) by the EU MS   
 
Health problem under scrutiny 
° Europe is facing continuous threats related to emergent communication diseases, with natural or 
intentional release as illustrated by several ev ents caused by infectious pathogens, air borne 
diseases (influenza, measles, legionella), water and food borne diseases (virus and E. coli, etc) in 
recent years. Such threats will, by definition not  stop at borders and preparedness and response 
depends on timely and accurate identif ication of the specific agent.  
° Evidence base for EU action:  In the past, differences in public  health preparedness and response 
have repeatedly been seen within the EU resulting in delayed public health interventions. Different 
responses to similar health threats in the different  EU countries are likely to negatively affect the 
acceptance of the general public and the compliance by health professionals.  
 
Objectives and means of EU policies/ action in the specific area 
Objective:  To support the EU MS to assess and develop core capacities to comply with IHR 2005 
requirements51. 
Means of action:  
° Legislative action: (a). Commission communi cations (2003/545 and 2006/5520), followed by 
Council conclusions (30/11-1/12/2006): the Commiss ion will help the implementation of the IHR 
at EU level by strengthening collaboration with WHO; (b). Directive 2010/65 on reporting 
formalities from ships arriving and/or departi ng from ports; (c). Decision No 2119/98/EC setting 
up the epidemiological surveillance and contro l of communicable diseases (annex I incl. diseases 
covered by the international hea lth regulations and ot her unclassified serious epidemic disease)52;  
° Strengthening the risk assessment and capacity to  respond to health threats due to biological, and 
chemical agents, and create a sustainable and integr ated strategy at EU level for safeguarding the 
health of citizens and preventing the cross-border spread of diseases. 
 
MS action in the same area 
° Member states are in the process of developing na tional plans to strengthen their core capacities in 
relation to surveillance and response to all health threats in line with their legal obligations under 
the IHR. 
 
Aim of EU funded action(s) under evaluation 
To support the EU MS to acquire the core capacities for the implementation of the International health 
regulation (IHR 2005), including the emission and exch ange the maritime declaration of health in 
electronic format, in compliance with Directive 2010/65, no later than 1 June 2015.  
EU added value 
Principal type of EU added value:  
                                                 
51 The IHR 2005 set implementation deadlines fo r parties to assess and deve lop core capacities to meet its requirements in 
relation to surveillance and response to all health threats and to  have developed and implemented plans to ensure that these 
core capacities are present and functioni ng within their territories (within 5 years of entry into force, i.e.2012) 
52 The EC is currently developing an impact assessment for an initiative on "Health Security in the European Union", 
which examines inter alia options for legal basis of the He alth Security Committee to suppor t the Council in achieving a 
coherent approach to the preparedness for and response to he alth threats and especially public health emergencies of 
international concern as defined in IHR 2005;  
 
 116° Implementation of legislation: supporting the EU MS to acquire the core capacities for the 
implementation of the Internati onal health regulation (IHR 2005) 
Additional EU added value:  
° Exchange of good/ best practices:  the sanitation inspections SHIPSAN TRAINET European 
Manual, proves the benefit of adopting common inspection standards and complying with the 
maritime declaration of health .  
° Networking:  the relevant EU networks are a key to ol for supporting the implementation of IHR 
2005, involving a multidisciplinary group of expert s, strengthening cooperation between different 
sectors, national and intern ational organisations.  
 
Activities 
The EU health Programme has funded several ac tions to develop a framework to identify and 
exchange good practice in all preparedness activities,  including their transferability and procedures for 
travel related contact tracing53.  
  
Results/outputs 
The European networks have produced results releva nt to support the EU MS acquisition of the core 
capacities for the implementation of the IHR 2005. 
° The SHIPSAN project has developed the Eu ropean Manual for hygiene standards and 
Communicable Disease surveillance on passenger ships. 
° The REACT project developed training tools and models addressing generic preparedness and 
response for the international spread of infectious disease at European level.  
° The Episouth project developed reports and con cept for future collaboration in Cross-border 
epidemic intelligence, Vaccine preventable diseases and migrants, Cross-border emerging 
zoonoses and Training in applied epidemiology, an d developing the Med iterranean network.  
° The EpiSouth+ is working on the establishment of the Medite rranean regional laboratories 
network, development of generic preparedn ess plan and risk management procedures. 
 
Target groups 
Three are the main target groups: 
° MS authorities and decision makers, with responsibili ty in implementing health protection policies 
and procedures and more specifically the key actors for the organization of the response. 
° Those directly involved in the maritime transport industry, travellers, workers in transport sector, 
port authorities (for SHIPSAN); expe rts and public health professiona ls for the other projects.  
° European citizens at large at risk in case of outbreaks.  
Within these three groups it is important to differentiate between the following categories: 
° Potential (the wider community of healthcare prof essionals/ other experts, MS authorities and EU 
citizens that may be affected by an event as described above) 
° Expected (those of the previous group expressly targeted by the activities of the actions under 
review) 
° Reached (those of the previous group effectiv ely reached during the duration of the action). 
Impact can be strengthened ever y time we cross another level. 
                                                 
53 SHIPSAN, SHIPSAN II, REACT, EpiSouth, EpiSouth+  
 117 
Expected impact 
Taking into account the nature of the funded actions , i.e. networking, development and exchange of 
good/ best practices and support to implementation of  legislation, the following indicators can be 
considered (in growing order of importance): 
° Part of the areas relevant to the IHR 2005 effec tively covered by the actions: for SHIPSAN, the 
successive projects address all of the relevant stakeholders and cover a significant part of the 
thematic area. The other actions have a more limited scope, both th ematic (generic preparedness 
and capacity building), as well as geographic (Southern European MS)   
° Coverage of the target population in terms of effective dissemination of the results : again there is a 
difference between SHIPSAN and the other actions; the sanitation inspections manual refers to an 
obligation for the reporting formalities for ships and therefore, dissemination and coverage is 
ensured. For the other projects such disseminati on is extensive within the networks funded, but 
there is no structured methodology for reaching stakeholders outside the project groups. Moreover, uptake by the participating partners needs to be demonstrated. 
° Impact from the implementation of the available tools and interventions: again, the expected 
impact is different for SHIPSAN and the other projects: t he hygiene inspections applying common 
sanitation standards are expected to have a significant contribution to the reduction of food borne and waterborne diseases, as demonstrated by US Vessel Sanitation Programme (VST). Additionally, experience acquired with SHIPSAN wi ll be useful for the development of the cargo 
ships manual and inspection programme. 
For the other actions, the networking and exchange  of experience elements could lead to the 
achievement of the set objectives, such as strengt hening of core capacities and the development of 
a coordinated public health culture of risk asse ssment and risk management of hazards events. 
However, it is difficult to establish the cau sality link between the implementation of an 
intervention within a project setting and its impact.  
° Sustainability and impact on the long term
 
The need for strengthening core capacities and fost ering European collaborations (networking) with 
the aim of developing risk assessment and risk  management skills and tools is permanent. 
However, each of the networks has a restricted thematic or geographical focus, which may affect 
its sustainability, unless they are streamlined in a more structured, long term framework. 
 
Is it possible to differentiate the impact of EU funded actions under review from MS action? 
° The responsibility to develop core capacities to comply with IHR 2005 requirements with each 
MS individually as signatory party to the international agreement. However, at least for the area 
covered by SHIPSAN, the link is clear between th e EU level collaboration and strengthening of 
core capacities at MS level. 
 
Conclusion 
° The objectives, structure, activities and outputs of EU action in the field of support to the 
implementation of the IHR 2005 follow clear and solid intervention logic  with, at least, a 
sufficient degree of expected impact. 
° Activities under SHIPSAN cover in a comprehens ive manner the entire thematic area and its 
deliverables are directly linked to reporting forma lities for ships, its effects finding fertile ground 
outside its initial scope (from passenger ships to cargo). 
Other projects in the area are also structured so as to  ensure impact in their specific context and in line 
with the main and specific objectives which they ha ve set to achieve; however, it is more difficult 
 118to establish the causality link between the implemen tation of each of the actions and the desired 
result in terms of strengthening core capacities.  
 
Other considerations for the future 
° The experience acquired with SHIPSAN will be u seful for the development of the cargo ships 
manual and inspection programme covering chemi cal hazards what will increase the EU added 
value by the development of the risk assessme nt tools for chemical threats in the cargo 
transportation in Europe and the definition of measu res for prevention, control and use of adequate 
decontamination measures, to avoid the risk for seafarers, passengers and port officers.  
° Other actions reveal the difficulties to effectivel y cover gaps in MS capacities: for example the 
communicable disease surveillance of  health care workers (frontline responders) is difficult, costly 
and in some countries even impossible due to the legal barriers.  
° Future efforts should address the fact of the rest ricted thematic or geographical focus of the 
networks and the need to streamline them in  a more structured, long term framework. 
 119CSE STUDY N°8: Projects in the area of Organ donation and transplantation in Europe  
 
Health problem under scrutiny 
° The availability of donor organs is often a qu estion of life and death for patients requiring a 
transplant (28.000 patients per/ year in the EU for a waiting list of approx. 80.000). The overall 
insufficient availability of organs in MS is tack led by exchanges of organs across the EU, with the 
benefits of also ensuring a better match between  donor and recipient and thus improving the 
quality of the transplantation. 
° Evidence base for EU action:  Available organs should be ab le to cross borders without 
unnecessary problems and delays. Inconsistent safety an d quality of organs and different levels of 
efficiency in national transplant systems require EU-wide action.  
 
Objectives and means of EU policies/ action in the specific area 
Objective:  Ensure availability of organs of human or igin for transplantation across the EU, while 
adhering to the best standards for safety and quality. 
Means of action:  
° Legislative action:  (a). Directive 2010/53/EU on standards of  quality and safety of human organs 
intended for transplantation; (b). Co mmission Action Plan on Organ Donation and 
Transplantation, strengthened cooperation between Member States (COM (2008 819/3)) 
° Support projects and joint actions that help Me mber States to develop common knowledge, share 
experience and expertise, identify and share good pr actices, identify and foster cooperation in the 
overall area of organ donation and transplantation. 
 
MS action in the same area 
° The concrete organisation of donati on and transplantation is to be taken up at national level by the 
national competent authorities. National competent authorities are regularly invited to present their 
activities and national action plans to their peers in the network of competent authorities, for 
mutual inspiration and learning. 
 
Aim of EU co-funded action(s) under evaluation 
Several projects have been funded – although diver se, they share key characteristics, including main 
and specific objectives: 
Main objective:  
Support MS in their efforts to achieve a consis tent high number of safe and qualitative organ 
transplants. 
Specific objectives:  
° Developing common standards and procedures for safety and quality; 
° Raising awareness with a view to increase donation rates; 
° Identifying, documenting and sharing good prac tices to increase organs from deceased donors, as 
well as to obtain organs from living donors; 
° Fostering cooperation and suppor ting exchange of know-how a nd capacity building activities; 
 
EU added value 
Principal type of EU added value:  
° Implementing different aspects of EU le gislation on safety and quality of organs   
 120Additional EU added value:  
° Economies of scale:  it would be too complex and demanding for one Member State to develop all 
aspects of knowledge e.g. development of registri es for patient follow-up or utilisation and need 
for transplant centres can be optimized by establishing multi-country collaborations  
° Promotion of best practices:  variation in efficiency, organisation and number of 
donations/transplants, as well as safety indicated strong potential for identification and sharing of good/best practices  
° Benchmarking for decision making:
 several project outputs serve as guidance for next legislative 
steps at EU level. 
° Free movement of persons : while patients could go cross-border to access surgery, access to 
organs abroad is to be coordinated between Member States  
° Networking:  different projects bring competent authorities of different Member States regularly 
together. Twinning brings specific experts of 2 or more Member States together.  
 
Activities 
° Development of common standards and procedures of safety and quality:  
¾ firstly in Directive 2010/53/EU and the (planned) implementing legislation 
¾ specific procedures/elements are further addressed in different projects like post-transplant 
follow-up or registries on living donors. 
° Development of campaigns to raise public awareness/willingness to donate. 
° Identification, documentation and sharing of g ood practices to increase organs from deceased 
donors. 
° Identification, documentation and sharing of g ood practices to obtain organs from living donors. 
° Expert visits, exchanging of know -how between national experts. 
° Establish cooperation between di fferent EU Member States. 
 
Results/outputs 
Analysis show that the most valuable resources developed are: 
° Shared models for standards, procedures and databases/registries; 
° Manuals/toolboxes with guidance for organi sational set-up and training programmes; 
° Exchange of expertise and knowledge, especi ally on quality systems and indicators; 
° Cross-border collaborations; 
° Increased public awareness/willingness for organ donation; 
Expected short term outcomes of above actions are:  
° The set up of a national competent authority a nd establishment of national safety and quality 
standards; 
° The set-up and identification of donor coordinators; 
° The monitoring of activity of transplant centres. 
 
Target groups 
Three are the main target groups of the work:  
 121° Policy makers: specifically national competent au thorities and all institutions/ organizations  
involved in coordinating and overseeing activities within a MS; 
° Healthcare professionals and other experts in  the related areas: transplant centres, 
procurement/donor centres, health professionals active in transplantation, etc. 
° The general public, i.e. those that may or may not  be affected by the specific health problem, 
either as transplant candidates or organ donators. 
Within these three groups it is important to differentiate between the following categories: 
° Potential (the wider community of healthcare prof essionals/ other experts, authorities and citizens, 
whether targeted by the action(s) or not) 
° Expected (those of the previous group ex pressly targeted by the funded activities) 
° Reached (those of the previous group effectiv ely reached during the duration of the action). 
Impact can be strengthened ever y time we cross another level. 
 
Expected impact 
The funded actions consist of supporting MS in their efforts to implement EU legislation; this is done 
by initiating different types of activities addr essing specific issues that are critical for the 
application of the legislation and included in the action plan (i.e. safety and quality issues; 
awareness issues; increased organ availability; etc. ). These efforts are supported by a network of 
national competent authorities which ensure linka ge between actions at the EU and MS level. 
In view of the above, the following indicators can be considered (in growing order of importance): 
° Part of the issues related to ensuring the obj ectives of the EU action covered by the actions : The 
portfolio of funded actions  ranks highly on this leve l, as all relevant areas which are critical for the 
successful implementation of the EU legislation and the achievement of its goals are covered. The  
° Coverage of the target population, in terms of e ffective dissemination of the results of the funded 
actions  (development of common standards, exchange  of best practices, capacity building and 
cooperation, etc):  at this level, impact can be measured by simple means, by comparing levels of 
access of target groups to the knowledge and tools developed under the programme; by the 
expansion of the target groups be fore and after the action, to include other MS: by measuring the 
degree of uptake of the knowle dge, standards, good practices and tools by the different target 
groups. For example, effective implementation of  quality and safety standards by responsible 
authorities in MS or setup of registries, etc. The horizontal linkage of the different thematic 
actions through the network of national competent au thorities is a factor that can lead to a wider 
and more active uptake by MS. 
° Impact from the use of the tools and know ledge developed unde r the funded actions:  
The use of the tools and knowledge produced in the framework of the funded actions should lead to 
achieving the objectives of EU action in the area, i.e.  a well organized transplantation system ensuring 
the quality and safety of human orga ns, increasing organ availability and enhancing the efficiency and 
accessibility of transplantation systems in the EU. 
It is however difficult to pinpoint the concrete impact due to missing long term indicators. For 
example, transplant donor coordinators undertook traini ng, but it is too early to identify the effects of 
that training in improving their skills and its effects on organ availability. The development of 
campaigns for raising awareness poses the same problem,  i.e. a long time frame is required to measure 
the impact of awareness actions and their eff ect in increasing availability of organs, etc. 
° Sustainability and impact on the long term:  
The directive incorporates a monitoring element which, together with the functioning of the 
networks of national competent authorities w ill provide a long term framework for action. 
 122Is it possible to differentiate the impact of EUfunded actions under review from MS action? 
The development of knowledge, tools, manuals, tr aining courses and organisation of exchange of 
expertise between Member States can be clearly identified at EU level. Nevertheless, to have full 
impact, results/inputs of EU activities are to be take n up in national activities, in particular by national 
competent authorities. A consistent and comparab le evaluation of national uptake would further 
contribute to enable the concrete measurement of impact of EU activities.   
Conclusion 
° The objectives, structure, activities and outputs of the actions funded in the area of organ donation 
and transplantation follow a cl ear and solid intervention logic  with, at least, a sufficient degree of 
expected impact. 
° The fact that these activities are undertaken under a specific legal framework and in close relation 
with the network of the national competent au thorities enhances their impact by ensuring 
transferability: the results of the different funded ac tions can be expected to be up taken in the MS 
and contribute to the improvement of the situa tion as regards quality, safety and availability of 
organs, as well as quality of the transplantation process. 
 
Other considerations for the future 
° The setup of programme level objectives and indi cators could facilitate the measurement of 
concrete impact with respect to the projects funded under this topic area.