COMMISSION STAFF WORKING PAPER Impact assessment
Date: 2011-11-09
Institutions: European Commission
Subjects: disease prevention, economic growth, health care system, health costs, health risk, innovation, medical research, right to health, sustainable development

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 Growth Programme, the third programme of EU action in the 
field of health for the period 2014-2020 

{COM(2011) 709 final} 
{SEC(2011) 1323 final} 

 
 
 
 
  
 
 
Contact: Irène Athanassoudis: 36572 ─ Myriam Cazzaniga: 35093 

3.  

2.  

3.1. 

Introduction ......................................................................................................................................3 
Procedural issues and consultations with third parties.........................................................4 
1.  
1.1.   Organisation and timing ...................................................................................................4 
1.2.   Expertise and consultations..............................................................................................4 
1.3 Impact Assesment Board's comments:...................................................................................7 
Problem definition................................................................................................................8 
2.1.   Policy context...................................................................................................................8 
2.2.   Defining the problem and its causes and effects ..............................................................9 
The Policy Objectives ........................................................................................................15 
Policy objective 1: Contributing to innovative, efficient and sustainable health systems
15 
Policy objective 2: Increasing access to better and safer healthcare for EU citizens.....19 
Policy objective 3: Promoting good health and preventing diseases to improve citizens' 

3.2. 
3.3. 
health  21 
Policy objective 4: Protecting citizens from cross-border health threats .......................22 
3.4. 
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 
EU added value ..............................................................................................................34 
4.3. 
5.  Links between the Health for Growth Programme and the EU 2020 Strategy ......................38 

5.1. 
Provide innovative solutions for improving the quality and sustainability of health 
systems .......................................................................................................................................38 
5.2. 
Support and complement the efforts of Member 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 
Option 2..........................................................................................................................42 
6.3 
Option 3..........................................................................................................................44 
6.4 
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 
Indicators........................................................................................................................59 
7.4. 
Evaluations .....................................................................................................................63 
7.5. 
ANNEX 1: DGs IN THE STEERING GROUP.............................................................................64 
ANNEX 2 - Timetable ...................................................................................................................65 

1

 
 
 
 
 
 
 
Ex-post evaluation of the Public Health Programme 2003-2007(conducted by 

ANNEX 3: 
COWI S/A)  66 
Executive summary ........................................................................................................................68 
1.1 
Introduction ....................................................................................................................68 
1.2  Methods..........................................................................................................................68 
1.3  Main results and conclusions .........................................................................................69 
Recommendations ..........................................................................................................72 
1.4 

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 
Conception .................................................................................................................74 
1.1.1 
Design.........................................................................................................................75 
1.1.2 
1.1.3 
Management ...............................................................................................................75 
1.2. The five highest ranking 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 LEGISLATION AND LEGISLATION ON 
PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES ..............................................85 
ANNEX 7: CASE STUDIES .........................................................................................................90 
1.1.  CASES STUDY N°3; ORPHANET: The EU portal for rare diseases and orphan drugs

100 

2

 
 
 
 
 
INTRODUCTION 

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 provision was to be followed up by a detailed legal proposal for a 
future Health Programme, to be adopted by the College by the end of 2011. 

This report therefore has to be seen as a key milestone in this process. 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  Health  Programme  and,  finally,  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 and other stakeholders). 

•  Section  2  describes  the  policy  context  in  which  the  Programme  will  operate  and  the  main 

challenges common to all Member States creating incentives for action at EU level. 

•  Section 3 explains the objectives 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  expected  impact,  and  are  then  compared  with 
each other in order to conclude which one is the most suitable choice. 

•  Section  7  sums  up  the  main  factors  and  indicators  for  monitoring  and  evaluating  the 

Programme.  

Finally, seven annexes add further details: 

•  Annex 1: List of participants in the Steering Group for drafting this report. 

•  Annex 2: Timetable for drafting this report and further steps. 

•  Annex 3: Key points and executive summary, 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 the 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. 

3

 
 
                                                 
•  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 intervention logic, EU added value, results and 

impact of action financed under the current and previous Health Programmes. 

1.  

PROCEDURAL 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  Strategy  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 June 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, Occasional Papers 74/December 2010, prepared by the 
European  Commission  and  the  Economic  Policy  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 effective way to improve health?’ 

•  Other studies, in-depth surveys and impact assessments 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)  grew  out  of  a  small  number  of 
isolated, empirically managed activities in response to calls from the Council and 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. 

4

 
 
                                                 
priorities gradually increased, to meet the new expectations, until they reached a point well above 
what  could  be  manageable  and  make  a  strong  impact.  Nevertheless,  the  evaluation  of  the  PHP 
recognised its strong potential contribution to preparing, developing and implementing EU public 
health policies even if it tried to cover too broad spectrum of health priorities. 
The 2nd Health Programme  (2008-2013) followed similar 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 minor in terms of a magnitude, it has a significant 
impact on the work done by public health practitioners 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  health  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 collection 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 activities, for example on health determinants 
and  comparable  health  data,  in  new  Member  States,  where  the  economic  situation  and  budget 
restrictions would not have allowed them to be made a priority. 

Third, the current Programme has promoted important issues at EU level and on national political 
agendas,  such  as  rare  diseases  and  cancer-screening  guidelines.  It  has  also  influenced 
policymaking and implementation at national level. In this context, dissemination 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  sufficiently  known,  so  not  always 
recognised and used by stakeholders and policymakers. 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  significant  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 positively received and widely used.  

1.2.2. Main conclusions of the evaluations and 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,  bringing  the  biggest  EU  added 
value.  It  was  underlined  by  the  Court  of  Auditors  in  the  report  ‘The  European  Union’s  Public 
Health Programme (2003-2007): an effective 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  relatively  low  Gross  National  Income  (GNI),  where  numerous 
cultural,  procedural  and  financial  barriers  reduce  the  opportunities  to  participate.  Emphasis 
should  be  placed  on  areas  where  Member  States  cannot  act  in  isolation  in  a  cost-effective 
manner, where there are clear cross-border or internal market issues or where there are significant 
advantages and efficiency gains from collaboration at EU level.  

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 number of activities to the ones that concern the 

4 http://eca.europa.eu/portal/pls/portal/docs/1/2838313.PDF. 

5

 
 
                                                 
most Member States and where there is a real value in taking action 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 was 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 through the EU Health Policy Forum, by health 
professionals  and  patients  associations.  Other  stakeholders,  especially  the  beneficiaries,  have 
expressed their views in recent evaluations. 

Representatives of Member States and NGOs participating in the various consultations strongly 
supported  the  continuation  of  the  Health  Programme.  While  unanimously  agreeing  with  this 
need, some Member States concurred with the view 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 objectives 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  framework  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 their national health policies. 

National  focal  points,  designated  by  Member  States’  authorities,  argued  that  the  Programme 
should continue to support national policies by: 

•  providing best practices to follow at national level; 

•  sharing and exchanging practical experience, expertise 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; 

6

 
 
•  other  topics  mentioned  less  frequently:  health  technology  assessment,  sexual  health  policy, 

health indicators, etc. 

Furthermore, Member States and stakeholders alike 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  literacy  and  the  fight  against 
health  inequalities.  According  to  them  the  current  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  the  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 advised - one that is equipped with 
adequate resources and that reflects non discrimination in healthcare 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  public  health  and  its  outcomes. 
Prioritisation  of  projects  within  the  Programme  should  be  discussed  with  the  stakeholders. 
Moreover the Programme should have longer as well as short terms goals.  

In addition coordination  between  European and national  programmes could be a guarantee 
for  greater  involvement  of  Member  States  and  a  solution  to  avoid  fragmentation  of  efforts 
deployed in multiple levels (national, local, European). The difficulties to access the Programme 
were raised by some members of the Forum, even if it was understood that there are strict rules 
for the use of EU funds. In the areas 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 stakeholders 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 participating 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 present the policy context and a table explains the 
link  between  identified  challenges,  MFF  announcements,  policy  objectives  and  specific 
objectives;  evaluation  recommendations  have  been  added  to  the  problem  definition,  more 
explanation  and  evidence  have  been  added  about  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-options 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 been added also from previous 
programme experience. 

7

 
 
 
Regarding the indicators, we have 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 developed. And impact indicators can only be about the 
uptake 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 different Member States and stakeholder groups, on top 
of the actual results achieved compared with predefined levels. 

Finally, evaluations arrangements have been improved and more details have been provided on 
stakeholders views. 

2.  

PROBLEM DEFINITION 

In order to demonstrate the value 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 area of health, with its inherent limitations. 

2.1.   Policy context 

The points already included in the Commission’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 cross-border health threats, 

to increase the sustainability of health services, 

to improve the health of the population, whilst encouraging innovation in health. 

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

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

8

 
 
 
Four  particularly  important  factors  for  the  design  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 scope of the Programme, proposed below in Section 
3,  takes  full  account  of  these  principles,  in  both  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  expresses  ‘policy  in  numbers’,  in  that  the  funding 
must  go  hand  in  hand  with  the  existing  regulatory  environment  and  the  policy  priorities  in  the 
relevant areas. 

As  a  consequence,  in  order  to  ensure  that  its  output  and  impact  push  forward  the  key  policy 
priorities of the EU, in line with the Europe 2020 Strategy, the Programme will concentrate on a 
limited number of high-profile priorities 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 challenges for Member States are serious while the expectations of the 
patients and stakeholders are high. Member States are under pressure to strike the right balance 
between  providing  universal  access  to  high  quality  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 Treaty, is to complement and support these national 
policies and encourage cooperation between Member States.  

The challenge is to build an EU Health Programme that serves the best the interests of Member 
States and other stakeholders within a limited budget. It is therefore necessary to prioritise needs 
in such a manner that results of the Programme are used and create a leverage effect to support 
and develop health policies at European, national and local level.  

The Programme should provide possibilities to build and strengthen cooperation mechanisms and 
coordination processes between Member States with a view to identifying common tools and best 
practices that create synergies. It should bring the biggest EU added value and lead to economies 
of scale, thus supporting reforms under challenging circumstances. 

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 defined objectives linked to actions and corresponding performance 
indicators.  As  a  result,  the  PHP  had  no  strategic  focus.  For  example,  the  programme’s  'action 
areas' established in the annual work plans (AWPs) outnumbered the projects funded to address 
them  and  there  was  no  sufficient  competition  between  the  proposed  projects.  The  project 
9

 
 
 
proposers  were  invited  to  apply  for  funding  under  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 Europe. 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  achievement  of  HP's  goals  and  how  progress  can  be 
effectively  measured.  Additionally  there  is  still  not  enough  of  prioritisation  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. 
Recommendations5 stemming from the report of the Court of Auditors in 2008 and the external 
evaluations  of  the  previous  and  current  programmes  demonstrated  that  the  problem  lies  in  the 
design of the Programme itself. In all audits and evaluations similar recommendations were made 
(see comparative table with the highest ranked 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 needs 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 expected outcomes will be used to improve national 
health policies. The Programme should support actions with proven EU added value and suggest 
solutions  that  cannot  be  found  by  each  MS  individually  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_finance/publications/occasional_paper/2010/pdf/ocp74_en.pdf)" 

10

 
 
                                                 
largest 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 important role to play in the economy in general and 
in  contributing  to  the  Europe  20209  Strategy.  There  is  a  strong  evidence  of  the  link  between 
health and economic performance:10 a population in good health is a sine qua non for attaining 
smart, sustainable and inclusive growth. 

Good  health  is  one  of  the  most  important  factors  for  increasing  individual  productivity  and 
consumer  empowerment.  An  increase  in  the  number  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  innovation,  as  health-related  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 aged 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 related not only to protecting, promoting and improving 
the health status of the elderly, but also to financing the rising healthcare costs and to improving 
the healthcare offered, in response to higher expectations, and also access to it. 

In order to ensure that the potential improvements 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, however, clear that they are strongly linked, that there 
is the European wide context that requires EU-wide collaboration and common responses, with 
due respect to the principle of subsidiarity and the ultimate responsibility of Member States. 

A  well  designed  and  realistic  Health  Programme  can  contribute  to  and  complement  Member 
States' actions to increase the number of years Europeans live in good health through finding and 
applying innovative solutions for the improvement of quality and sustainability 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 health 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 sectors. 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/LexUriServ/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 function — health compared to total’. 2009: 14.63 %. 

11

 
 
                                                 
are  challenged  by  an  ageing  population,  rising  expectations  for  high-quality  services  and  the 
emergence  of  new  technologies.  These  constraints  have  increased  with  the  curbs  on  public 
spending in the wake of the debt crisis. 
Evidence14  suggests  that  effective  health  system  reforms  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  States  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  broader  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  and  to  the  related  costs.  Planning,  costing  and 
reimbursement  of  healthcare  services  is  one  key  area.  In  this  context,  the  role  of  health 
technology assessment as a tool to be used across the EU and for achieving economies of scale by 
working closely with other Member States is a priority. A second key area is close collaboration 
on addressing the scarcity of resources, 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 Member States can learn from sharing experience 
and practice, both positive and negative. 

2.2.4. Health workforce shortages 

Demographic  developments  in  the  EU  will  result  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  changing  family  structures,  the  demand  for  formal,  professional  care  is 
increasing.  Healthcare  has  also  become  more  specialised  and  requires  more  intense  work  and 
longer training. These trends are currently challenging the traditional 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  could  therefore  benefit  from  cooperating  with  each 
other. Health workforce shortages can increase regional 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/urban  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 European Court of Justice shows that some Member States have 
resorted  to  measures  that  are  in  breach  of  the  principle  of  free  movement  of  persons,  e.g.  by 
limiting the number of foreign students in their medical faculties or halting emigration of freshly 
graduated health professionals. Efforts should be made to support Member States in addressing 
these  challenges  in  collaboration  and  not  in  isolation,  in  particular  their  efforts  on  educating, 
recruiting  and,  especially,  retaining  young  practitioners  in  all  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 estimated 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. 

12

 
 
                                                 
On  average  in  western  European  countries,  about  10 %  of  patients  suffer  an  adverse  event,16 
which  has  consequences  for  them  and  the  healthcare  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 extra 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 reviews 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 Organisation (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 conditions. 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 rates 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  States.  More  worryingly,  recent  studies  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  collaborate  to  develop  and  disseminate 
validated  tools  and  approaches  for  prevention,  but  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 the 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 challenge: time to react’, September 2009: 
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500008770.pdf. 
19 Impact Assessment on a proposal for a Council Recommendation 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/LexUriServ.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  doi:10.1093,  European  cancer  mortality  predictions  for 
2011. 

13

 
 
                                                 
of  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 widely from one Member State to another. 

In  addition,  a  significant  level  of  premature  mortality  or  premature  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  working  age  totalled  approximately  900 000,  equivalent  to 
about 19 % of all deaths that year.22 
Also people with health problems 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  disability.  Development  of  the  human  capital  crucial  for  a 
knowledge-based economy is therefore greatly impaired. 

The financial impact is significant: it is estimated 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  twice  as  much  on  illness 
and disability benefits as on unemployment benefits. 

Solutions  to  these  problems  depend  not  so  much  on  gaining  better  insights  into  the  most  cost-
effective  ways  to  reduce  premature  mortality,  since  the  factors  most  to  blame  for  modest  HLY 
are known,25 but more on understanding ways to implement 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 redressing the loss of the best years of productive life. 

2.2.8. Increasing inequalities in health throughout Europe 

Health  inequalities  have  become  a  central  concern  of  policymakers  in  many  parts  of  the  world 
and the EU offers a striking image in this respect. Population health varies enormously between 
different  parts  of  the  EU  and  between  advantaged  and  disadvantaged  groups.  Life  expectancy 
amongst males  varied by 11.9 years between Member 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 nearly 20 years. Life expectancy for the Roma 
population is up to 10 years shorter than the general population. 

The main causes of these inequalities in health are systematic difference in determinants of health 
experienced  by  different  populations,  including  social,  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 reunification, Robert Koch Institut, Berlin, 2010. 
27 Mackenbach article in The Lancet on UK experience 

14

 
 
                                                 
Although, clearly, part of the link between the causes and effects of health inequalities could lie 
outside  the  health  policy  area,  primarily  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 application of the Cross-border Healthcare Directive. 

2.2.9. Global and cross-border threats 

After the industrialised world was close to eradicating the most serious infectious diseases in the 
late 1970s, the rapid social and economic changes triggered by globalisation have brought new 
factors that are driving the return of old pathogens and the rise of new ones. 

The  Treaty  gives  the  European  Union  specific  responsibility  for  averting  cross-border  health 
threats, i.e. events caused by communicable diseases 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 threats 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 part of crisis preparedness and management. 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 functioning and the borders in the EU open. 

3.  

THE POLICY OBJECTIVES 

The challenges identified in section 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 intervention on four key policy objectives, covering five 
specific objectives for actions described below in this section. 

"The new Health for Growth Programme will be oriented towards actions with clear 
EU  added-value,  in  line  with  the  Europe  2020  objectives  and  new  legal  obligations. 
The principal aim is:  
- to work with Member states to protect citizens from cross-border health threats,  
- to increase the sustainability of health services, 
- to improve the health of the population, whilst encouraging innovation in health". 

(Commission’s Communication ‘A Budget for Europe 2020’) 

3.1. 

Policy objective 1: Contributing to innovativeand sustainable health systems 

By  supporting  Member  States'  efforts  to  improve  the  efficiency  and  financial  sustainability  of 
health care, the EU Health Programme aims at encouraging a shift of significant resources in this 
sector on the most innovative and valuable products and services which at the same time offer the 
best  market  potential  and  cost  savings  in  the  longer  term.  Health  system  reform  must  clearly 
consist of a mix of immediate efficiency gains with longer term strategic action addressing key 
cost drivers. This is the only way if countries are to ensure universal access and equity in health, 
health  financing  and  use  of  the  system.  As  an  example,  European  cooperation  on  health 

15

 
 
 
 
technology assessments will not only reduce duplication and pool expertise but can unlock the 
potential for sustainable innovation in health products and services. 

It is of utmost importance to develop common tools and mechanisms at EU level to help national 
health systems deliver more care with fewer resources. Innovative solutions are needed to tackle 
workforce  shortages  and  to  maximise  the  efficiency  of  health  systems  through  the  use  of 
innovative products, services and tools. 

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

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

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 facilitate 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  upcoming  therapies  based  on 
genomic  science,  an  adequate  supply  of  health  professionals,  expertise  necessary  to  improve 
decision-making, as well as support for the Innovative 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  assessment  (HTA)  can  provide  decision-makers  with  an  evidence-based, 
transparent basis for decisions on taking up and phasing out health technologies, thereby making 
the  best  use  of  health  budgets  and  providing  the  best  treatment  to  patients.  In  the  increasingly 
difficult  context  of  constrained  financial  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  HTA  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 continue 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-effective  health  intervention  at 
national/regional levels and thus obtain economies of scale; 

16

 
 
•  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  guidelines  for  submissions  by 

industry  on  pricing  and 
reimbursement of new medicines and medical devices, so that the industry can improve the 
quality of data from its clinical trials submitted to the assessment bodies; 

the 

•  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  care.  After  substantial  support  for  large-scale  projects  to  develop  such 
interoperable tools, there is now a clear need for Member States and stakeholders to take some 
tangible  decisions  in  order  to  achieve  effective  interoperability.  Otherwise,  the  risk  of  making 
massive  e-Health  investments  suitable  for  local  solutions  only  will  increase  and  will  prevent 
patients from having access to cross-border care. In addition, the Directive provides for drawing 
up guidelines on use of e-Health solutions as a way 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 consultation 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  use  of  medical  information  for  public  health 

purposes and research, including 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  solutions  to  strengthen 
healthcare,  for  example  by  increasing  efficiency  and  promoting  safety  and  quality.  A  common 
approach in the EU is needed for topics which call 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 health 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  skills,  to  monitor  mobility  (within  the  EU)  and 
migration of health professionals, to develop efficient 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 needs, 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  context  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. 

17

 
 
•  Promoting successful strategies for professional recruitment to the health sector and retention 

of health workers in their jobs. 

•  Encouraging cross-border education and training by implementing 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 system reforms. This is crucial in order to secure 
the  long-term  sustainability  of  Member  States’  health  systems.  To  avoid  duplication  of 
assessments  at  Member  State  level  and  to  speed  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  initiated  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 information to take into account in their 
decisions. Provision of such advice will be all the more necessary in the current context and over 
the years ahead and should therefore be continued after 2013. 

3.1.5. European Innovation Partnership on Active and Healthy Ageing 

Announced in October 2010 as part of the Commission's "Innovation Union" strategy, the pilot 
European  Innovation  Partnership  on  Active  and  Healthy  Ageing  represents  a  new,  stakeholder-
driven  approach  to  research  and  innovation.  The  ambition  is  to  connect  diverse  actors  and 
programmes in order to improve the conditions for innovation and bridge gaps between research 
and market, whilst ultimately benefit the final users – the older people, care providers and health 
professionals and other carers. 

The  Partnership  offers  a  coordinated  framework  for  existing  instruments  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  management  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  inclusion,  working  conditions  for  older  people,  older  people's 
participation in the labour market, independent living in an age-friendly environment. 

18

 
 
The Health Programme may provide support to specific actions under the Partnership.  

3.2. 

Policy objective 2: Increasing access to better and safer healthcare for EU citizens  

Improving  access  to  healthcare  to  all  citizens  regardless  of  income,  social  status,  location  and 
nationality  is  a  key  to  bridging  the  current  substantial  inequalities  in  health.  All  EU  citizens 
should  have  access  to  safe  and  high  quality  healthcare  regardless  of  their  circumstances.  
However, in reality, access to healthcare still varies significantly in the EU. It is also recognized 
that health is a key driver of inequalities, as poor health status often has a substantial impact on 
accessibility  to  effective  health  care  and  the  possibilities  of  individual  citizens  to  act  on  health 
information disseminated at national and European level. Action under all the objectives of the 
programme  should  help  contribute  to  bridging  such  inequalities  by  addressing  various  health 
factors  that  give  rise  to  and  increase  inequalities,  as  well  as  complement  action  under  other 
programmes specifically addressing social and regional differences within the EU.  

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

To achieve this, the Programme will: 

Specific objective 2: increase access to medical expertise (European reference networks) and 
information  for  specific  areas  and  beyond  national  borders  and  develop  shared  solutions 
and guidelines to improve healthcare quality and patient safety in order to increase access 
to better and safer healthcare for EU citizens 

Scarce knowledge can be shared and resources combined as efficiently as possible across the EU, 
as can be seen, for instance, in the case of rare diseases.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 specific disease or group of diseases. 

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

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

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

3.2.1. 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. 

19

 
 
                                                 
European reference networks (ERNs), to be set 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  and  evaluating  the  ERNs.  Once  the  period  for 
transposition  of  the  Directive  ends,  in  October  2013,  the  operations  and  logistics  related  to  the 
actual launch  of the  ERNs will start,  in particular with the development of methods to identify 
and designate the centres and manage the networks on a permanent basis. This would imply: 

• 

• 

launching  the  process  for  identifying  and  designating  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 mechanism for running the network satisfactorily 

(means, structure and human and material resources should be decided); 

•  accrediting and supporting a number of European reference 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 Healthcare Directive. The aim is: 

• 

• 

• 

to put in place an improved coding and classification system for rare diseases, as part of the 
ongoing  revision  of  the  International  Classification  of  Diseases  (ICD)  to  be  adopted  by  the 
WHO  in  2014,  and  contribute  this  to  a  WHO-based  global  approach,  in  collaboration  with 
other international 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 support to Member States in developing their national strategies: 
the  Council  Recommendation  on  action  on  rare  diseases  commits  Member  States  to 
developing  national  plans,  including  common  European  elements,  to  facilitate  cooperation, 
but this is technically challenging 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 between them to maximise European cooperation and efficient use 
of resources. 

3.2.2. Strengthening collaboration on patient safety and quality of care  

The  Programme  will  strengthen  the  EU  collaboration  on  patient  safety  and  quality  of  care 
initiated  by  the  joint  action  in  2011  with  two  goals:  implementation  of  the  Council 
Recommendation  on  patient  safety  and  structured  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 

20

 
 
                                                 
The  position  of  the  patient  can  be  strengthened  in  order  to  achieve  better  healthcare  outcomes. 
Patients  can  be  empowered  to  manage  their  health  and,  partly,  their  healthcare.  For  this,  the 
transparency  of  healthcare  activities  and  systems  and  the  availability  of  information  to  patients 
should  be  optimised  and  healthcare  practices  should  learn  from  the  feedback  from  and  inter-
communication with patients. 

3.2.3. Improving the prudent use of antimicrobial agents in human medicine  

The  Programme  will  strengthen  the  EU  coordination  in  the  form  of  supporting,  in  close 
cooperation  with  the  food  safety  and  animal  health  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 spread 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 patient safety, including HCAI, to increase 
the cost-effectiveness and impact of the national measures against HCAI. 

Policy  objective  3:  Promoting  good  health  and  preventing  diseases  to  improve 

3.3. 
citizens' health 

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

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

To achieve this, the Programme will: 

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

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 factors. These risk factors can only be effectively addressed across 

21

 
 
 
society  if,  at  the  same  time,  underlying  socio-economic  factors,  such  as  health  inequalities, 
mental health and well-being, and environmental factors are also taken into account. 

Addressing  nutrition,  obesity,  poor  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  against  smoking  (to  replace  the  ongoing  anti-tobacco 
campaign); and ongoing support on effective 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 stakeholders — including employers, non-governmental 
organisations,  economic  operators  and  other  interest  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; 
• 
•  establishing  a  validation  mechanism,  at  EU  level,  that  will  show  how  practices  and 
community-based intervention can be assessed with a view to sustainable implementation at 
the level of whole populations; 

fostering effective cooperation between Member States; 

•  supporting adequate dissemination 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  for  chronic  diseases  in 
public  health  and  health  care  systems.  These  include:  health  promotion  and  prevention, 
healthcare  –  including  the  development  and  dissemination  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 development of high-quality population-based organised 
screening programmes for breast, cervical and colorectal cancer aiming at very high population 
coverage. It is set out in the Council Recommendation on cancer screening. 

The Programme will also support the update/revision of the EU cancer-screening guidelines and 
the development of further, science-based European guidelines for scaled-up cancer prevention. 

3.4. 

Policy objective 4: Protecting citizens from cross-border health threats  

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

To achieve this, the Programme will: 

22

 
 
Specific  objective  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 

In order to minimise the public health consequences of cross-border health threats which could 
range  from  mass  contamination  caused  by  chemical  incidents  to  epidemics  or  pandemics,  like 
those unleashed recently by E coli, H1N1 or SARS (severe acute respiratory syndrome), robust 
mechanisms and tools to detect, assess and manage major cross-border health threats need to be 
established or reinforced. Due to the nature of these threats, coordinated public health measures 
at  EU  level  are  needed  to  address  different  aspects,  building  on  preparedness  and  response 
planning,  robust  and  reliable  risk  assessment  and  on  a  strong  risk  and  crisis  management 
framework. 

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

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

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

3.5.  Horizontal activities 

In  addition,  the  Programme  will  support  two  horizontal  activities  that  cut  across  the  policy 
objectives described above and contribute to the main aim of the Programme, although they can 
also run independently of the existence of the future Health Programme. 

3.5.1.  Actions required by or contributing to the objectives of EU legislation 

All  the  legal  obligations  deriving  from  existing  legislation  and  legislation  currently  under 
revision  have  been  regrouped  under  this  specific  chapter.  Often,  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 Commission is under legal obligation 
to take these measures. (see Annex 6 for the indicative list of legislation). 

Following  various  meetings  with  DG  BUDG  and  SEC  GEN,  these  activities  have  been  split 
between  the  4  objectives  listed  above.  They  are  grouped  per  these  objectives  in  the  following 
section. 

SPECIFIC OBJECTIVE 1: 

23

 
 
Medical devices30 

The objective is: 

•  To  manage,  implement  and  develop  the  legislation  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  fundamentally  revised  with  the  aims  to  ensure  EU-
wide,  uniform  high  level  of  protection  of  human  health  and  safety,  to  provide  a  regulatory 
framework  which  supports  innovation  and  the  competitiveness  of  the  European  ‘medtech’ 
industry,  to  enhance  the  transparency  of  the  regulatory  system  and  to  ensure  the  smooth 
functioning of the internal market for medical devices. 

In addition, synergies can 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  technologies  which  could  contribute  to  mitigating  the 
shortage of healthcare professionals and to the sustainability 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 implementation of the current EU legislation 

on the safety and quality of substances of human origin (SoHO). 

•  To  follow  up  innovative  scientific  and  technological  developments/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  the  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  contribute  to  specific  objective  3,  healthcare 
quality and patient safety, by providing guidance 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-border  healthcare  in  order  to  avoid  further 
litigation on the issue of patient mobility  by clarifying patients’ rights 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 healthcare provision in border regions. 

30 Corresponding costs are financed under the ‘Internal 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 

24

 
 
                                                 
(c) Medicinal products32 

The objectives are: 

•  To meet its obligations in the medicinal products field, the Commission will be required 
to manage, maintain and implement the legislation on medicinal products for human and 
veterinary use, including proposals for future legislation, 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 implementing newly adopted legislation on 

pharmaco-vigilance and falsified medicines; 

2.  establishing  the  list  of  non-EU  countries  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  standards  and  control  methods  for  medicinal 
products by funding the specific activities undertaken 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 public 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 medicinal products would contribute 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 implementation 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 information 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  contribute  to  specific  objective  4,  on  prevention 
measures, by providing guidance to Member States on good implementation of legislation. 

32 Corresponding costs are financed under the ‘Internal market for goods and sectoral policies’ until 2013. 

25

 
 
                                                 
SPECIFIC OBJECTIVE 4: 

 (c) Health Security Initiative 

The objective is: 

•  To  improve  public  health  pandemic  and  generic  preparedness  and  response  following 

lessons learned from past events, including the 2009 pandemic. 

3.5.2. Health information and knowledge: to contribute to evidence-based decision making, 
including  collecting  and  analysing  health  data  and  wide-ranging  dissemination  of  the 
results of the Programme 

Following  various  meetings  with  DG  BUDG  and  SEC  GEN,  these  activities  have  been  split 
between the 4 objectives listed above in proportion to their contribution 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  identification,  dissemination  and 
application of best practices while also highlighting 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-related obstacles to growth. 

Harmonised collection of comparable data also helps to reduce the administrative and economic 
burden on Member States by reducing multiplication 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  disseminating  these  indicators  on  health  status,  health 
systems,  social  determinants  of  health  and  health  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  the  area  of  health,  with  particular  attention  to  support  for  the 
sustainability of health systems. Within these objectives, priority will be given to information and 
evidence in areas where (a) the greatest EU added value can be demonstrated 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 indicators 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  relevant  policymaking,  identify  research  priorities  and  provide 
monitoring and guidance on new and emerging health and environmental issues. This is currently 
being  done  by  the  Commission’s  Scientific  Committees  and  will  be  continued  in  the  next 
Programme. The objective is to be a centre of scientific excellence for the EU and internationally. 

Wider dissemination of the results of the EU Health 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 dedicated IT tools, like 
26

 
 
the EU Health Portal, as well as through dedicated actions (publications, brochures, road shows 
etc.) and information campaigns in close cooperation with Member States themselves.  

3.6.  Context of the Programme 

The  proposed  Programme  can  contribute  to  addressing  the  above-mentioned  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 inherent limitations.  

First  of  all,  the  Programme  cannot  replace  Member  States’  action.  Instead,  as  stated  in 
Article 168 of the Treaty on the Functioning of the European Union, EU action must complement 
national policies and encourage cooperation between Member States. Thus, the 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 health problems vary from one Member State to 
another and that Member States’ capacity to solve them might not necessarily be equal. From this 
perspective,  cooperation  might  not  always  be  a  process  that  is  self-organising  and  natural.  The 
EU  will  therefore  intervene,  preferably,  where  it  can  promote  and  steer  this  coordination  at 
European  level,  while  also  serving  the  interests  of  the  Member  States  and  of  the  wider  public 
health agenda. 

Third,  as  explained  in  the  section  on  the  policy  context,  the  Commission  is  committed  to 
delivering  on  Europe  2020  goals.  This  implies  that  the  Programme  also  has  to  contribute  to 
achieving  these  goals.  Still  in  line  with  the  EU  2020  objectives,  the  action  taken  in  the 
Programme must prove to have real EU added value and a measurable impact. 

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, other funding programmes also contribute to improving public health 
in  the  EU,  most  notably  the  public  health  component  of  the  Research  Programme  and  of  the 
Structural  Funds.  However,  the  Health  Programme  is  the  only  one  aiming  specifically  at 
addressing  the  challenges  and  concerns  in  the  health  policy  field,  while  also  enabling  further 
achievement  of  the  policy  goals  in  this  area.  Its  success  can  be  magnified  by  forging  the 
necessary links and clear synergies 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  objectives,  specific 
objectives and Programme actions 

The table below summarises these links. 

27

 
 
 
 
 
 
28

 
 
 
         ‘HEALTH IS THE GREATEST WEALTH’ (Virgil, 70-19 BC) 

Innovative, 
efficient and 
sustainable 
health systems 

More access to better 
and safer healthcare 
for EU citizens 

Promote good 
health and prevent 
diseases 

Protect citizens 
from corss-border 
health threats 

Develop common 
tools and 
mechanisms at 
EU level to 
address shortages 
of resources 
(human and 
financial)  

Develop and 
increase access to 
medical expertise 
(European 
reference 
networks) and 
information 
beyond national 
borders 

Develop shared 
solutions and 
guidelines on 
healthcare 
quality and 
patient safety 

Develop and 
disseminate 
validated best 
practices for cost-
effective prevention 
measures  

Develop common 
approaches and 
demonstrate their 
value for better 
preparedness and 
coordination in 
health 
emergencies

HTA, 
genomics , 
Health 
investment
E-Health 

Health 
workforce 
needs and 
planning 

Rare diseases,
extended EU 
reference 
networks 

Patient safety 
and quality of 
systems  

ti-
microbial 
resistance 
(AMR), 
HCAI 

Major and 
chronic 
diseases  

Defined Risk 
factors  
and risk 
populations 
AIDS/HIV, 

Communicable 
diseases and 
vaccine-
preventable 
diseases)  

Health 
Security 
Initiative 
… 

Health inequalities 

Stakeholders’ 
involvement 

Cooperation with 
third countries 

HEALTH   
INFORMATION AND KNOWLEDGE 
AREA 
(Risk assessment, EU health 
monitoring system)  

29

HEALTH LEGISLATION
(medicinal products, medical 
devices, blood, tissues, etc., 
Cross-border Healthcare 
Directive, Health Security 
Initiative, tobacco control) 

 
 
 
 
 
Policy 
objectives 

Contributing to 
innovative, 
efficient and 
sustainable 
health systems 

Increasing access 
to better and 
safer healthcare 
for EU citizens 

Promoting good 
health and 
preventing 
diseases to 
improve citizens' 
health 

Specific objectives 

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 

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 

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 

No 
objective 

policy 

No specific objective 
No actions 

The overall health 
challenges 

Financial sustainability 
of health systems 

Health workforce 
shortages 

Improvements necessary 
in patient safety 

The announcements 
in the MFF 
sustainability of 
health services while 
encouraging health 
innovation 
- a common EU 
approach to health 
technology assessment 
(HTA) 

sustainability of 
health services while 
encouraging 
innovation in health 

sustainability of 
health services while 
encouraging health 
innovation 
- Rare diseases 
- supporting European 
reference networks on 
diseases 
increase the 
sustainability of 
health services 

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 

Not in the MFF 

      (Increasing 
inequalities) 
Addressed only partially 
as side effect of the 
specific objectives 

30

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Global and cross-border 
threats 

to protect citizens 
from cross-border 
health threats 

Protecting 
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 

31

 
 
 
4. 

SUBSIDIARITY 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 action has to be taken are also mentioned: 

• 

improving public health, 

•  preventing physical and mental illness and diseases, 

•  obviating sources of danger to physical and mental health, 

• 

• 

• 

fighting against the major health scourges, 

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

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

The same article also suggests ways to contribute to the fight against 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  subparagraph  of  Article  168(2)  states  that  ‘The  Commission  may,  in 
close contact with the Member States, take any useful initiative to promote such coordination, in 
particular initiatives aiming at the establishment of guidelines and indicators, the organisation of 
exchange of best practice, and the preparation of the necessary elements for periodic monitoring 
and evaluation.’ 

Paragraph 3 of the same Article then goes on to say that ‘The Union and the Member States shall 
foster  cooperation  with  third  countries  and  the  competent  international  organisations  in  the 
sphere of public health.’ 

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

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 cases they can only take action after coordination at 
EU level. For some countries, the cooperation between Member States is particularly beneficial. 
There is a better chance of solving global issues and common concerns by mobilising efforts at 
EU level and establishing common values and principles. 

The  Programme  will,  in  particular,  fund  action  that  cannot  be  carried  out  as  effectively  by 
Member States themselves but depends greatly on cooperation at EU level. 

32

 
 
 
Here are some examples of such actions:  

Under specific objective 1. Health Technology Assessment (HTA):  

Improving  cost-effectiveness  of  health  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 can, y identifying resource-effective, safe aand 
effective  intrventions,  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  treatment  to  patients.  HTA  is  a  important  tool  but  unfortunately 
related resources, knowledge and expertise are unevenly spread in Europe. EU action in this area 
could provide economies of scale, insofar common methodological standards for the assessment 
of  different  health  technologies  lead  to  simplified  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 (often acting as fisrt line carers) and wide community, due to costly 
management.  Low prevalence, as well as low number of patients by diseases and per Member 
State leads to large variance in access to diagnosis, to quality care and ultimately, 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 member sattse level gives high potential added value 
to  Eu  level  action.  The  Programme  could  support  generation,  translation,  validation  and 
dissemination of knowledge and information in this area.  

Under specific objective 3. Revision of the EU cancer-screening guidelines for high-quality 

screening programmes for breast, cervical and colorectal cancer33 and treatment: 
In the fight against cancer, EU cooperation has already proven its added value. A study in 2003 
showed a reduction of 9 % in expected cancer deaths and of 10.5 % in the risk of cancer death 
between  1985  and  2000  and  concluded  that  the  ‘Europe  Against  Cancer’  Programme  (1987–
2000)  had  contributed  to  these  results.  The  Commission  has  therefore  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 diseases, with natural or 
intentional  release  as  illustrated  by  several  events  caused  by  highly  pathogenic  agents  in  the 
recent past (H5N1, Chikungunya, H1N1, E.coli etc). Such threats will by definition 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 laboratories at individual EU Member 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. 

33

 
 
                                                 
 
More 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-border 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 civil 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, are facing particular challenges. 
Emphasis  should  be  given  to  stakeholders  from  Member  States  with  low  GNI  who  remained 
inactive during the previous Health Programmes and to small entities facing language problems 
and other barriers. 

The common nature of the challenges and the opportunities for growth as a result of better health 
make  the  Programme  increasingly  important.  Its  own  particular  value  is  as  a  unique  bridge 
between technological innovation, social policy and practice. Its specific objectives aim to have a 
catalytic effect and help the parties involved find 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  Structural  Funds  and  the  Research  Framework 
Programme. In particular, the Programme will offer significant scope for connecting research to 
policy,  practice  and  implementation  and  developing  innovative  knowledge  transfer  throughout 
Europe, including possibly neighbouring and other non-EU countries. For the above-mentioned 
reasons, the outcome of the Programme will be unique and should be disseminated strategically. 

4.3.  EU added value 

European  added  value  is  the  value  that  EU  action  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 added 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  additional  value  it  might  have  over  action  by  individual 
Member States.35 

The value of investing in preparedness, prevention and coordination of measures on health threats 
and communicable diseases at EU level was clearly demonstrated by the H1N1 outbreak in 2009. 
Strengthening  the  capacity  to  manage  serious  cross-border  health  threats,  along  with  joint 
procurement  of  vaccines  against  pandemics,  is  another  area  where  significant  EU  added  value 
can  be  obtained.  The  EU  can  also  deliver  significant  benefits  on  cross-border  issues  such  as 
cross-border healthcare and health inequalities and by developing strategies to counter growing 
antimicrobial resistance, along with cost-effective health technologies and innovative healthcare, 
and promoting healthy ageing with the aid of a European Innovation Partnership. 

Action under the Health Programme complements and adds value to Member States’  action on 
health  promotion  and  prevention  of  illness  (including  work  on,  for  example,  nutrition  and 
smoking and on reducing inequalities in healthcare), protection of citizens against health threats, 

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 striving to maximise the effectiveness and efficiency of its 
action in these fields. 

34

 
 
                                                 
in  particular  pandemic  preparedness,  the  safety  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 Programme if they are to take place.  

•  Cooperating  on  cross-border  diseases  such  as  H1N1  flu  also  cannot  be  undertaken  by 
individual Member States, but depends on initiatives and funding at EU level. In the area of 
health  threats,  the  EU’s  role,  beyond  coordinating  the  response  to  these  threats,  is  also  to 
enhance  the  capacity  of  the  Member  States  and  of  non-EU  countries  to  respond  to  these 
threats.  Providing  a  rapid  and  coordinated  answer  to  global  health  threats  is  also  the  EU’s 
role. 

•  The  Health  Programme  has  developed  and  strengthened  networks  between  European  health 
specialists,  national  and  regional  health  authorities  and  other  stakeholders  who  greatly 
contribute  to  sharing  knowledge  and  building  health  capacity  in  the  EU.  It  has  also  built 
consortia,  partnerships  and  other  ways  to  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 effective, if not the only, way to 
build  the  evidence  base  for  defining  much  broader  regulatory  policies  (for  instance,  on 
cancer, Alzheimer’s, rare diseases and health inequalities). 

In the context of the mid-term evaluation of the 2nd Health Programme and based on the in-depth 
analysis of the case studies (see more in Annex 7) most of the following EU added value criteria 
were developed on the basis of the subsidiarity principle and Article 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 selection 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 value expected in relation to the objectives of the 
Health for Growth Programme.  

35

 
 
Specific 
objectives 

EU added 
value 

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 
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.  

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 

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. 

36

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
concentration of 
skills and 
knowledge. 

reducing health 
inequalities between 
EU Member States  

37

 
 
 
 
LINKS  BETWEEN  THE  HEALTH  FOR  GROWTH  PROGRAMME  AND  THE  EU  2020 

5. 
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 

Provide  innovative  solutions  for  improving  the  quality  and  sustainability  of  health 

5.1. 
systems 

According to the Joint Report on Health Systems 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 health 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  economic  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.  Key  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 and 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 products or public health 
genomics,  aim  to  strengthen  the  link  between  technological  innovation  and  commercialisation, 
while  ensuring  security,  quality  and  efficiency.  Other  initiatives  are  focusing  on  e-Health 
solutions and fostering interoperability at EU level 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  contributes  to  both  organisational  innovation  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 working conditions; and improving the conditions for job creation). 

Support  and  complement  the  efforts  of  Member  States  to  increase  the  number  of 

5.2. 
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 life 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  provides  a  crucial  boost  to  the 
economy, with an impact on the labour market. While 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_paper/2010/pdf/ocp74_en.pdf. 
38 See Council conclusions on innovation in the medical device sector, adopted on 6 June 2011, OJ C 202, 8.7.2011, 
p. 7 

38

 
                                                 
national  wealth  is  associated  with  improved  health,  only  more  recently  has  the  contribution 
which better health makes to economic growth been recognised.  

Lacking the proper facilities to improve the health of the population, to prevent and treat diseases 
and injuries and to reintegrate people 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 generating social cohesion, a productive workforce, employment and, 
hence, economic growth. 

6. 

POLICY 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  action  cannot  be  funded  from  credits  secured  under  specific  budget 
lines.  Until  2013,  it  will  be  financed  under  the  current  Health  Programme  and  the  ‘Internal 
market for goods and sectoral policies’. 

For instance, the EU pharmaceuticals legislation provides for the Commission to adopt decisions 
on  marketing  authorisations  for  medicinal  products  for  human  and  veterinary  use  (Regulation 
(EC)  No  726/2004).40  In  addition,  the  transparency  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 alone, the Commission adopted 1279 decisions in 
this  area.  Given  the  number  of  decisions  and  their  voluminous  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 operated 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,  medical  devices,  vigilance  reports  and  clinical  investigations  in  this 
databank, so that the information can be shared between the national authorities. Eudamed will 
be  further  developed  to  establish  it  as  the  central  and  publicly  accessible  EU  registration  and 
listing  database  for  economic  operators  and  medical  devices,  integrating  a  function  for  tracing 
medical devices by means of a unique device identification (UDI). The future Eudamed will thus 
ensure a high level of transparency in the field of medical devices placed on the EU market, but 
significant financial resources will 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  actions  resulting  from  the  legal  obligations 
imposed  by  the  Treaty  and  the  existing  EU  acquis  in  the  field  of  medicinal  products,  medical 
devices,  substances  of  human  origin,  patients  rights  in  cross  border  healthcare,  Health  security 
(cross border health threats) and tobacco. 

39 http://ec.europa.eu/health/ph_overview/Documents/health_economy_en.pdf. 
40 EU pharmaceuticals legislation also provides for the Commission 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) 

39

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

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

• 

• 

• 

• 

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

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

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

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

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

• 

• 

• 

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

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

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

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

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

6.2   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 recommendations made by previous evaluations. 

In  this  case,  the  Commission  would  concentrate  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 (blood, tissues, cells and organs); 

•  patients’ rights in cross-border healthcare; 

• 

• 

tobacco product and tobacco advertising directives; 

the Health Security Initiative. 

40

 
6.2.1. 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, supporting 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 these 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  the  implementation  of  innovative 
solutions and techniques in the area of health; 

 -  the  sustainable  growth  objective  by  not  supporting  MS  in  finding  sustainable  solutions  for 
healthcare systems, including prevention; 

 - the inclusive growth objective by not working on the health workforce shortage problem. 

6.2.3.  Improvement  of  the  design  and  monitoring  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 objectives of EU legislation. 

This would of course not 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 results of the current Health Programme will lead 
to the situation where most of them would actually be lost. For instance, common guidelines for 
cancer  have  been  developed  thanks  to  the  Programme  and  are  now  being  applied  at  national 
level.  Failing  to  update  them  at  regular  intervals  on  the  basis  of  scientific  developments  and 
assessments would deprive Member States and 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 effectively by Member States alone but depends 
greatly on cooperation funded at EU level would 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, possibly very dramatic situations, it is important that Member States 
are  well-prepared  in  advance  and  are  accustomed  to  cooperate  as  much  as  possible.  In  the 
absence of common training and exercises, guidelines and compatibility among Member States' 
procedures,  there  is  a  serious  risk  that  diseases  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 (sometimes 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 expertise across the Union, which makes much more 
efficient  use  of  the  limited  resources  in  this  area,  is  likely  to  be  abandoned  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: 

41

 
In  this  option,  no  support  would  be  given  to  the  Member  States,  in  the  form  of  cooperation, 
sharing knowledge, exchange of best practices etc. Thus probably the degree of importance to do 
things in certain areas would decrease in Member States, which would, in turn, have a negative 
incidence on the sustainability of health systems. 

The EU Health Programme as such could not be used 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, especially as many Member States budgets need to be 
reduced due to the financial crisis. 

In addition, under this option None of Member States' and stakeholders' concerns will be taken 
into account.  

6.2.5. 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  however  no  synergies  could  be  developed  as  there 
would be no programme.  

6.2.6. Impact of the simplification 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 limitation of activities to be funded and their size. 

6.2.7. Compatibility with the available resources 

This option would be compatible with the available 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  corresponds  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 health information and knowledge. 

For  each  of  these  broad  and  general  objectives,  there  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 that 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  recommendations:  the  number  of  projects  to  be 
financed annually has been decreased significantly, priority areas are set internally and proposed 
funding is set against these priorities. This prioritisation 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. 

42

 
                                                 
6.3.1. 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  encouraging  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 into account Commission's political priorities as 
formulated in the EU 2020 strategy. 

In  addition,  except  for  the  implementation  of  legislation,  the  repartition  of  budget  between  the 
objectives (should be towards an equal split) would make it much more difficult to finance all 
the actions on HTA, health workforce, e-health, sustainability of health 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  monitoring  of  the  Programme  as  recommended  in 
the evaluations 

This  option  would  mean  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  the  recommendations  made  by  the  Court  of 
Auditors  and  in  the  external  evaluations  (number  of  projects  to  be  financed  annually  has  been 
recently significantly decreased, prioritisation is being somehow improved).  

But in order to fully implement these recommendations, it’s the whole design of the programme 
that needs to be reviewed. It can only be done while preparing a new Programme. 

The main results would be: 

• 

• 

insufficient  focus:  a  long  list  of  items  would  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, meaning that again, the level of achievement of 
the  objectives  would  be  very  difficult  to  monitor,  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 neither result oriented, nor focused. A big variety of 
actions  can  be  undertaken  while  not  necessary  corresponding  to  the  real  needs.  Without  the 
strengthening of the dissemination the results of many of the projects would be lost. 

As a consequence the programme would not sufficiently contribute 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'  concerns  would  be  taken  into  account  only  to  some 
extend. 

6.3.5. 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 

43

 
These 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 other 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 available 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 made by evaluations of the previous and current 
Health  programmes  as  well  as  the  recommendations 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 needs and what is achievable within the limited 

budget, and 

• 

to support actions that will create proven EU added value. 

This  option  corresponds  to  a  well  structured  programme,  with  SMART  objectives,  prioritised 
actions, creating EU added value and with better monitoring of outcomes and impacts. 

An  idea  which  clearly  underpins  option  3  is  to  learn  the  lessons  from  the  previous  Health 
Programmes.  Although  this  option  may  be  equivalent  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 programme, focused and smart objectives 

Specific  objectives  (described  under  point  4)  have  been  determined  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  activities  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  equitable,  sustainable  and 
compatible  with  EU  2020  objectives.  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  specific  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 facilitate 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  networks)  and  information  for  specific  areas  and 
44

 
beyond  national  borders,  and  develop  shared  solutions  and  guidelines  to  improve 
healthcare  quality  and  patient  safety  in  order  to  increase  access  to  better  and  safer 
healthcare for EU citizens 

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  well  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  demonstrate  their  value  for  better 
preparedness  and  coordination  in  health  emergencies  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  Commission;  b)  the  potentiality  to  create  the  largest  European  added 
value according to the determined criterias (as described in the point 4.3), c) direct links with the 
challenges/real needs and policy objectives, d) past experience and the results of the evaluations; 
e) the level of importance for Member States policies 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.  Other  policy  areas  and  actions  will  witness  their 
budget increased. Last but not least a limited number 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 number of actions is reduced to 22 and the 
total number of outputs is estimated to 210.  

In line with the policy objectives the following actions 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  effectively  supported  by  other  EU  policies  and 
programmes than the modest Health Programme. 

Following objectives and horizontal activities will 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 achieved up to now and actions can 
focus more on networking or exchange of best practices 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 indicators. An evaluation 
on  the  use  of  relevant  EU  indicators  in  the  context  of  a  comprehensive  European  health 
monitoring system is ongoing. The acquisition, validation and dissemination of data can provide 
added  value  in  the  form  of  information  allowing  for  benchmarking  for  informed  decision-
making.  In  addition,  a  harmonised  collection  of  comparable  data  may  help  reduce  the 
administrative and economic burden on Member States 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 added value (cancer, chronic diseases); because of 
the impossibility for Member States to act alone (rare diseases and cross border health threats) or 
45

 
because  there  is  additional  ground  work  to  be  carried  out  in  view  of  further  developments  of 
in  cross  border  healthcare). 
for  patients 
existing 

(patient  safety 

legislation 

rights 

These actions address to great extend the real needs, challenges and 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  deemed  to  have  a  high  EU  added  value  in  that 
guidelines,  best  practices  and  advices  developed  with  the  support  of  the  Programme  could 
contribute to the sustainability and efficiency of health systems 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  example  has  a  recognised 
potential  for  generating  important  economies  of  scale,  notably  because  of  the  size  of  the 
population that they may affect.  

In addition, these are also political priorities of the Member States and the Commission, they are 
fully in line with EU 2020 agenda to support innovation in health and inclusive and sustainable 
growth. As they are relatively new they are also more costly for Member States than for example 
an exchange of best practices within already well established network. 

New actions under the new Health Programme are the one under support for the EU legislation 
on medicinal products and medical devices (transferred from Internal Market budget lines) and 
all  other  obligations  stemming  from  the  legislation  under  preparation.  Regarding  medical 
devices,  it  will  be  with  a  much  increased  funding  compared  to  the  years  prior  to  2014  as  the 
directive  is  currently  begin  revised  and  it  is  one  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  set  of  policy  objectives  and  horizontal  activities 
described under point 3. 

The repartition of credits per policy objectives and in comparison with the current programme in 
this option would be as follows: 

Evolution of allocations between old and 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  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 

Sub-total

9 

46

24.3 

15.3 

 
 
 
 
 
 
 
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 

Sub-total

9.8 

11.3 

1.5 

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

Sub-total

21.1 

10.9 

-10.5 

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 

TOTAL 

Sub-total

7.5 

47.4 

4.6 

51.1 

-2.9 

3.7 

6.4.1.1. Consistency with the announcements of the MFF communication  

Under  this  option,  the  Programme's  objectives  would  be  aligned  to  these  announcements  as  it 
would imply working with Member States: 

 - "to protect citizens from cross border health threats," as described under policy objective 4 and 
also by implementing the future legislation on Health Security; 

 - "to increase the sustainability of health services",  as  described  within  policy objective 1 and 
also, indirectly, under policy objective 3 with prevention aspects; 

  -  "to  improve  the  health  of  the  population  "as  described  under  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 legislation 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 Commission 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  sustainable  solutions  for  healthcare  systems, 

including prevention; 

• 

Inclusive growth - by working on the health workforce shortage problem . 

6.4.1.3. Improvement of the design and monitoring 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; 

47

 
 
•  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 established 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 the developed tools, mechanisms 
and advices 

At  policy  level,  these  items  will  support  Member  States,  policy  makers,  health  professionals, 
health institutions in reaching an adequate supply of health professionals in MS, reaching a cost-
effective  use  of  medical 
improving  decision-making,  organisational 
management and performance of the health systems. 

technologies  and 

For  instance,  with  HTA,  the  projects  funded  until  now  have  supported  the  establishment  of  a 
European HTA network, the development of common methodological basis for assessing health 
technologies  (so  called  "core  HTA  model"),  the  testing  of  this  core  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 gain better insight on 
the  feasibility  of  cooperation  models,  to  establish  scientific  guidelines  for  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 standardisation, at EU level, of data and information requirements from 
industry should have positive effects on transparency 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 Reference 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 developed guidelines on patient safety.  

At policy level, these items will support MS in improving access to diagnosis and provision for 
all  patients  requiring  highly  specialised  care  for  a  specific  disease  or  group  of  diseases  and  to 
support  MS  reducing  morbidity  and  mortality  related  to  healthcare  quality  and  increasing 
patients/citizens confidence in the health care system. 

For instance, the pilot European reference Networks (ERNs) in the 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 strategies, knowledge production and dissemination, 
empowerment of patient organizations; setup of pilot European Reference Networks.  

Analysis  of  networks  previously  and  currently  funded  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 healthcare 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  tools  for  exchange  of 
48

 
knowledge 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 further 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 stakeholders from bodies involved in 
good health and prevention of diseases, using the validated best practices in order to, at policy 
level, support Member States in their efforts to reduce risk factors for diseases. 

For instance, under the previous current Health Programme, the aim 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 colorectal and breast cancer;  

• 

• 

• 

the 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; 

the support of a cancer network; 

the  standardisation  of  data  in  relation  with  the  European  Community  Health  Indicators 
system; 

• 

the support of the European Network 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  institutions,  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 health measures at EU level to help minimise the public health 
consequences of cross-border health threats (which could range from mass contamination caused 
by chemical incidents to epidemics or pandemics). 

Leverage  for  Member  States'  health  policies:  In  this  option,  support  would  be  given  to  the 
Member  States,  in  the  form  of  cooperation,  sharing  knowledge,  etc  in  areas  falling  under  the 
specific objectives. Thus probably the degree of importance to do things in these areas could be 
increased in MS which would, in turn, take them into consideration in their own policies. 

49

 
For  instance,  to  support  the  acquisition  by  Member  States  of  the  core  capacities  for  the 
implementation  of  the  International  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  all  preparedness  activities,  including  their 
transferability  and  procedures  for  travel  related  contact  tracing.  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 European level (REACT project );  

reports and concept for future collaboration in Cross-border epidemic intelligence, Vaccine 
preventable diseases and migrants, Cross-border emerging zoonoses and Training in applied 
epidemiology, and developing the Mediterranean 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 diseases in ships, as already demonstrated by US Vessel Sanitation 
Programme  (VST).  Additionally,  experience  acquired  with  SHIPSAN  will  be  useful  for  the 
development of the cargo ships manual and inspection programme.  

For other actions, the networking and exchange of experience could lead to the strengthening of 
core capacities and the development of a coordinated 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 available 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  programme  dealing  only  with  the  same  set  of 
objectives and horizontal activities but, as a trade off, action on promoting health would not be 

50

 
carried out. Promotion of health is not retained as it is an area, according to evaluations, where 
impact is very difficult to measure and where it can only be measured on the long term.  

The repartition of credits per policy objectives and in comparison with sub-option 3a would be as 
follows: 

Policy objectives 

2014 – 2020 
(sub-option 3A) 

2014 – 2020 
(sub-option 3 B) 

difference 

Average per year 

24.3 

24.3 

11.3 

11.3 

0 

0 

10.9 

5.9 

-5 

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

contribute 

information 

increase  access 

(European 
and 

to  medical 
2) 
reference 
expertise 
for 
networks) 
specific  areas  and  beyond  national 
borders, 
shared 
solutions  and  guidelines  to  improve 
healthcare  quality  and  patient  safety 
in  order  to  increase  access  to  better 
and safer healthcare for EU citizen 

develop 

and 

in 

particular 

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

the  key  risk 

4)  develop  common  approaches  and 
demonstrate  their  value  for  better 
in 
preparedness  and  coordination 
to 
in  order 
health  emergencies 
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. 

51

 
 
 
 
 
 
 
 
 
 
 
Under 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 would be mostly aligned to these announcements 
but with a reduced contribution "to improve the health of the population" and also "to increase 
the sustainability of health services" as there would be no promotion of good health and health 
determinants anymore. 

6.4.5.2. Contribution to the EU 2020 strategy  

This  option  would  also  allow  the  Commission  to  contribute  to  these  objectives  but  to  a  lesser 
extent  than  option  3  A  as  the  objective  on  promotion  of  good  health  would  not  contribute  to 
sustainable growth anymore. 

6.4.5.3. Improvement of the design and monitoring 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 cancer 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  the  areas  that  are  very 
much demanded by Member States when they are consulted. 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  from  becoming  ill.  Commission  thus  ought  to 
participate,  generate,  support  work  in  this  are  as  it  also  serves  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 available 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 approaches and demonstrate their value for better preparedness and 
coordination in health emergencies in order to protect citizens from cross-border health threats. 

52

 
In addition, there would be some dissemination of the results of the current Health Programme 
(2008–2013) in order to take into account the conclusions of previous evaluations. 

Protecting citizens from cross-border health threats would be retained for funding first because it 
is  stipulated  under  the  article  168  of  the  Treaty.  Furthermore,  the  EU  added  value  of  this 
objective  is  clearly  established,  mainly  in  relation  to  the  cross  border  criteria,  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  command  comparison  with  Option  3  A  would  be  as 
follows: 

Average per year 

2014 – 2020 
(sub-option 
3A) 

2014 – 2020 
(sub-option 3 C)

difference 

24.3 

10.2 

14.1 

11.3 

4.5 

6.8 

10.9 

0.5 

-10.4 

Policy objectives 

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 
innovate  and 
to 
sustainable health system 

(European 

information 

increase  access 

2) 
to  medical 
expertise 
reference 
for 
networks)  and 
specific  areas  and  beyond  national 
borders, 
shared 
and  develop 
solutions and guidelines to improve 
healthcare  quality  and  patient 
safety in order to increase access to 
better  and  safer  healthcare  for  EU 
citizen 

identify, 

disseminate 

3) 
and 
promote  the  up-take  of  validated 
for  cost-effective 
best  practices 
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 

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 

53

 
 
 
Total 

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  undertaken  would  be  reduced  to  the  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  the  implementation  of  innovative 
solutions and techniques in the area of health; 

 -  the  sustainable  growth  objective  by  not  supporting  MS  in  finding  sustainable  solutions  for 
healthcare systems, including prevention; 

 - the inclusive growth objective by not working on the health workforce shortage problem. 

6.4.6.3. Improvement of the design and monitoring of the Programme as recommended in 
the evaluations 

Under this option, the design of the programme would 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 objectives, 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 cannot tackle issues alone (see rare diseases in 
option 1). 

In addition, most of the concerns of the Member 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 synergies could only be developed with the Health 
Security legislation (assuming 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  under  the  protection  of  citizens  from  cross  border 
health threats. This would of course not prevent the limitation of projects to be funded and their 
size. 

6.4.6.7. Compatibility with the available resources 

54

 
 
 
 
 
 
 
 
 
This 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 programme focusing on the same issues as option 3 
b)  but  adding  a  specific  objective  for  addressing  wider,  social  and  economic,  causes  of  health 
inequalities by appropriate means within the prevention of disease general objective. This option 
would imply a significant increase of the envelope for the programme. 

This would entail giving support to action taken by Member States - with a focus on countries 
and regions where health status and health inequalities are particularly negative - on: 

• 

implementing and evaluating evidence-based plans to address inequalities by means of public 
health action, across the health system and in coordination across relevant policy fields; 

•  developing  innovative  approaches,  by  providing  funding  for  specific  pilot  cooperation 
projects  between  Member  States  and  stakeholders  to  develop  joint  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;  developing  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 groups 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 health, 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  cooperation  between  Member  States  to  coordinate 
their  policies  and  programmes  on  public  health.  This  would  include  organising  exchanges  of 
good practice, drafting and establishing guidelines and indicators and monitoring and evaluation 
activities. 

It  would  also  include  stronger  mechanisms  to  engage  other  relevant  European  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  Commission  Communication  on  health  inequalities 
(COM(2009)  567),  the  Communication  on  Europe  2020  (COM(2010)  2020),  the  European 
Parliament resolution of 8 March 2011 on reducing health inequalities 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 investment 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  inequalities.  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  minimum  level  of  intervention  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 conclusions of the evaluation of the 
current Health programme and the requests for a continuation of the programme made by the EU 

55

 
Health  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  policies.  However,  in  the 
absence  of  intervention  logic,  lack  of  SMART,  focused  and  realistic  objectives,  with  a  large 
number  of  actions  not  prioritised  and  no  indicators  to  measure  the  achievements  or  indicators 
geared towards an hypothetic impact on citizens, which a programme supporting policies cannot 
have, any kind of impact would first be very difficult to measure and then very limited, because 
not part of a logic. This type of programme would 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  through  the  actions  defined  and 
prioritised in this impact assessment. The Commission's legal obligations would be fulfilled. 
The  proposed  Programme  would  address  the  main  criticisms  made  by  the  external  evaluations 
and  in  the  Court  of  Auditors  report.  It  would  have  an  intervention  logic,  well  defined  policy 
objectives, SMART, realistic, outcome oriented and pragmatic specific objectives, actions to be 
carried  out  would  be  prioritised  and  a  set  of  indicators  would  be  defined  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 determine 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 allow addressing satisfactorily the challenges faced 
in public health as the synergies between promotion of good health and chronic diseases would 
be  lost,  especially  regarding  citizens'  exposure  to  chronic  diseases.  The  programme  would  not 
respond to the expectations of Member States and other stakeholders. 

Option 3 C: 

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

3  out  of  4  of  the  specific  objectives  defined  in  this  impact  assessment  would  not  be  achieved. 
Such  a  programme  would  not  respond  to  the  expectations  of  Member  States  and  other 
stakeholders. 

Option 4: 

This option corresponds to a substantial increase of the Public Health budget which is simply not 
realistic. 

RESULT: Option 3a is thus, by far, the preferred one  

56

 
 
 
This can be summarised in the table below: 

Regarding achievement of the objectives of the Programme 

Options 

1 

0 

2 

+ 

3a 

3b 

3c 

4 

+++ 

++ 

+ 

+++ 

+ 

++ 

+++ 

++ 

+ 

++++ 

+ 

+ 

+++ 

+++ 

++ 

+++ 

0 

+ 

+++ 

++ 

+ 

+++ 

++ 

+ 

+++ 

+++ 

++ 

+++ 

+ 

+ 

+++ 

+++ 

++ 

+++ 

+++  +++

+++ 

+++ 

+++ 

0 

Impact/output  

a) Consistency with the 
announcements of the MFF 
communication:  

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: 

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 

+++ 
++ 
+ 

Satisfactory  
Limited  
No  

7. 

MONITORING AND EVALUATION 

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

7.1.  Multi-annual programming 

The proposal is to set up an indicative 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 Commission would set itself.  

It would serve as a guideline for the annual work plans. 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 the Programme also allows some flexibility at 

57

 
 
 
 
 
the 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 priority areas and increase the amounts of funding 
available  for  those  priorities  and  specific  actions  for  a  given  year.  This  will  rationalise  the 
preparation of the annual work plans and with fewer projects - the monitoring. It will also allow 
for more time to follow up results for policy work, dissemination, etc.  It will, last but not least, 
finally  facilitate  coordination  of  the  Programme  with  other  programmes  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 used in the Programme: calls for proposals, grants 
for  actions  with  Member  States,  grants  for  international  organisations,  operating  grants  and 
public  procurement  contracts.  As  said  in  the  evaluations,  the  experience  gained  from  their 
introduction  in  the  current  Health  Programme  was  positive  and  considered  as  an  improvement 
over  the  system  for  the  previous  Public  Health  Programme.  In  addition,  each  financing 
mechanism seems to contribute positively to achieving 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 involvement of Member States; 
•  Operating  grants  guarantee  the  funding  of  an  organisation  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  aims,  but  their  specifications  need  to  be  well  defined  in 

order to achieve the desired results. 

Clear  guidelines  will  continue  to  be  provided  to  potential  participants  so  that  they  can  decide 
which financing mechanism would be most appropriate for their proposal. Such guidelines were 
first provided for call for proposals 2007. According to the mid-term evaluation, 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-financing for grants for actions, actions co-financed by the competent 
authorities of the Member States or the third 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  limit  of  co-financing  through  Delegated  Acts 
procedure will bring more flexibility than under the current Programme.  

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

58

 
5. 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 limited number of submissions per year in response 
to the call for proposals for the Health Programme (for example, 113 in 2011), 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  process  for  that  Programme  is  strong  at  ensuring  that  appropriate 
and competent  applicants are selected for funding. The action  funded 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  the  evaluation,  guarantee  the  credibility  of  the  organisation 
performing  the  evaluation  and  offer  the  beneficiaries  advice/recommendations  from  scientific 
experts. The involvement of external evaluators also guarantees a fair process and equal access. 
Thus,  the  current  selection  process  is  an  improvement  compared  with  the  previous  Health 
Programme and will be continued. 

Three sets of criteria are considered, one after the 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  operational  capacity  stipulated  in  the 

proposal; and 

•  The award criteria include the quality of the action proposed, taking into account its costs. 
They  include  the  following  three  factors:  relevance  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 for Growth Programme is an EU spending Programme 
to support health policy. It is thus not possible for the Programme to have impacts other than the 
effective dissemination of its results and the acceptance of its outcomes by MS so that the results 
obtained can be put into practice.  

In designing the programme, end-users 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 State or stakeholders' level.  The Programme has no objective on 
individual citizens and cannot act directly at their level, which remains 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 production and dissemination of validated knowledge and evidence in the 
field of public health for health policy makers and 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 expectations of the Member States.  

Thus,  output  indicators  can  only  measure  the  production  of  these  best  practices,  tools, 
mechanisms, guidelines, that have been developed. And impact indicators can only be about the 
59

 
uptake 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 different Member States and stakeholder groups, on top 
of the actual results achieved compared 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  Programme  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  implementation  and  uptake  of  programme  outcomes  in  the  different 
Member States and stakeholder groups as well as the actual rate of predefined results achieved. 
In addition the visibility and uptake of outcomes of individual actions beyond the actors directly 
involved  are  a  valuable  measurement  tool.  In  order  for  this  to  be  achieved,  however,  the 
communication and evaluation mechanisms within individual 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 achievement of the objectives: outcome indicators and 
impact indicators for each of the specific objectives; 

there  are  indicators  addressing  issues  highlighted  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: regarding 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 impact 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 the specific objectives of 
the  Programme.  These  are  not  yet  finalised,  in  terms  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 financial, and facilitate up-take 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 medical expertise (European reference networks) 
and  information  for  specific  areas  and  beyond  national  borders,  and  develop  shared 
solutions  and  guidelines  to  improve  healthcare  quality  and  patient  safety  in  order  to 
increase access to better and safer healthcare for EU citizens 

Number  of  functioning  ERNs  by  20XX,  Number  of  healthcare  specialists  using  this 

43 CTME Comité permanent des médecins Europeéns, letter to Commission 29/6. 

60

 
 
                                                 
20YY 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  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 

Number of validated best practices developed 
by 20XX, 20YY and 20ZZ 

Number of Member States/stakeholders using 
them by 20XX, 20YY and 20ZZ 

Specific  objective  5:  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 

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 for the specific objectives can be summarised as the rate of use, by 
Member States and/or stakeholders, of the tools developed. 

To identify and measure the impact of the Programme, it is absolutely necessary 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 objectives/action are failing to meet Member States’ 
needs. 

It  is  therefore  suggested  that  the  National  Focal  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  and  evaluation  mechanisms  put  in  place  in  close 
collaboration with the NFPs (systematic feedback from questionnaires to stakeholders, revision 
of evaluation methods within the 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 the outcomes in the different Member States and 
by stakeholder groups, on top of the actual results achieved compared with predefined levels. 

7.4.2. Other indicators 

a) Rate of implementation 

In  accordance  with  the  objectives  of  the  Programme,  as  described  above,  and  with  the 
imperatives of the Europe 2020 Strategy, the proposed indicator is that: 

•  at least 40 % of the total budget for the Health Programme (on average for the period 2014–
2020)  be  allocated  to  action  supporting  the  safety,  quality  and  efficient  use  of  medical 
technologies  (pharmaceuticals,  vaccines,  medical  devices,  HTA,  genomics,  etc.).  This 
indicator  would  be  reviewed  and,  if  necessary,  revised  after  three  years  following  an 
evaluation of achievements and assessment of needs. 

b) Participation by Member States 

As regards satisfactory participation by Member 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. 

61

 
This  indicator  is  very  important  because  it  reflects  the  relevance  of  the  objectives  of  the 
Programme to Member States’ needs and its inclusive dimension.  Inactive Member  States will 
only be motivated to participate in the Programme if its objectives reflect their concerns. 

This  certainly  implies  that  administrative,  financial  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 model for EU co-financing should be 
activated. 

c) Communication and dissemination indicators 

To make it easier for Member States and stakeholders to take up outcomes and, thus, to make an 
impact, good communication and systematic dissemination 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 Programmes, 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  adequateness  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  clearly  and  potential  beneficiaries  did  not  know  what  was 
expected; 

the action is too ambitious in comparison with the indicative amount allocated; 

the action is not interesting for potential beneficiaries. 

e) Outcome indicators 

At  the  end  of  each  action,  systematic  monitoring  of  outcomes  under  each  of  the  specific 
objectives  is  required.  The  actual  rate  of  achievement  of  the  predefined  results  for  each  action 
linked  to  a  specific  objective  could  serve  to  justify  continuation  of  the  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 addressing health workforce shortages: 

•  By 2015, creation of an EU platform enabling Member 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. 

62

 
f) 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 evaluated by internal bodies; 

•  All long-term projects must be evaluated at appropriate 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  measuring  progress  made  in  meeting  the  Programme 
objectives,  determining  whether  its  resources  have  been  used  efficiently  and  assessing  its 
European added value. The mid-term evaluation will include a review of the indicators in order 
to  assess  their  relevance  and  revise  them  if  need  be  or  if  priorities  have  changed  since  the 
beginning of the Programme. Impact indicators will still be difficult to review 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 conducted, to a lesser extent, for specific 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. 

63

 
ANNEX 1: DGS 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 

64

 
 
 
 
 
 
 
 
ANNEX 2 - TIMETABLE  

Month 

Ex post finale 
evaluation 
of the PHP 2003-2007 

JAN 

FEB 

Reception of the final 
report 

MARCH 

Approval of final report 

Interim report 

Mid-term evaluation 
of the Health Programme 
2008-2013 and health 
Strategy 

Health Programme 
Post 2013 - 

Consultation  
Avec les stakeholders 

Inception report  

Concept paper and the draft Road Map IA 

24/02 - Roadmap submitted to SPG meeting and 
approved. 

Drafting of composite Impact Assessment for sec Gen 
15/03 - Roadmap sent to Sec Gen  
31/03 – Composite IA sent to Sec Gen 
Start the Impact Assessment  
15/04 - 1st meeting with the IA Steering Group (ISG on 
Health) 

21/01 - National Focal Points 
meeting  (tour de table 
17/02 - Programme Committee 
meeting 17/02 

18/03 - Meeting of the Senior 
Working level Group on Health  

4-5/04 - Informal EPSCO (Health) 
Council in Gödöllö 

19/05 - Health Policy forum 19/05 
30/06 – contribution from special 
working group from the Health 
Forum 

10/5 - amended interim report  Drafting 
30/6 - Draft final report 

10/06 - 2nd meeting of IA Steering group 

25/07 - Final report 

Drafting of a Commission 
staff working paper on this 
evaluation (unless we can add 
it to the Impact Assessment) 

18/07 – 3rd steering group 
Finalisation of impact assessment. 
24/08 – at the latest, submission to IAB 
21/09 – Impact Assessment Board 
Drafting of the new programme. 
Finalisation of draft of the new Health Programme and 
launch of the ISC 

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) 

65

APRIL 

MAY 
JUNE 

JULY 

AUGUST 
SEPT 

OCT 

NOV 

DEC 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 3:  EX-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 objectives 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 hampered 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 some extent. Beneficiaries are more optimistic compared with other stakeholders. 

The case studies document that the 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 achieved 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 regarded as success stories. The Commission 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 beneficiaries are familiar with the EU public health policy in general. They are also 
familiar with the general programme objectives and annual priorities 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.  

66

 
 
 
• 

• 

• 

It may be somewhat surprising that other stakeholders employed in the public administration of the Member States are not 
more familiar with the EU public health policy, general programme 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 beneficiaries 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 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 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 achievements. These success criteria should be based on a thorough 
elaboration of the intervention logic underpinning the 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 that such procedures do not increase the administrative burden 
for the end user and grant holders unnecessarily. 

3  DG SANCO should ensure that the priority areas in the annual work plans are focused 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 States 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. 

67

 
EXECUTIVE SUMMARY 

1.1 

Introduction 

The  overall  purpose  of  this  evaluation  is  to  assess  the  effectiveness,  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 assessed. 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 undertaken 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 the 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  are  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 they 
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 achievement. The caveat is thus that 
the use of the assessment of objective achievement is associated 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 straightforward - 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 specific 
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, and furthermore it is in the given context considered difficult to 
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 speculations, 
in  particular  by  project  participants,  are  likely  to  be  too  optimistic  -  a  caveat  that  in  practice  is  relevant  to  all  evaluation 
methodologies where assessments are based on subjective opinions. 

68

 
1.3 

Main results and conclusions 

European public health needs - relevance and European added value 

1.3.1 
The extent to which the PHP has addressed the perceived and real needs concerns three issues. Firstly, the extent to which the 
needs have been addressed in the annual work 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  whether  activities  have  actually  been  funded  in  the  priority  area. 
Finally, it concerns whether the needs have been addressed during the implementation of the activities funded, if any, to the 
extent  that  some  room  for  manoeuvre  remains  within  the  scope  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 listed in the annual work plans.  

This is in part a consequence of the far-reaching aim, objectives and priorities of the PHP - making it difficult to identify public 
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  the  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  financial  resources  of  the  PHP,  this  may  have  diluted  the  potential 
effects of the individual projects compared with a more targeted effort in selected areas. The point of view that there may have 
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 first 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 provided clear European added value. In this 
way, the projects selected may be regarded as success stories.   

There is no clear cut definition of European added value. According to the EAHC homepage, "European added value refers to 
the European dimension of the problem and of the project. Projects funded within the EU Health Programme are expected to 
contribute  to  solving  problems  at  the  European  level,  and  the  expected  impact  of  co-ordinating  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 view was also put forward by Commission staff interviewed during the evaluation.  

Effectiveness 

1.3.2 
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 linked objectives and corresponding performance indicators.  

While such lack of intervention logic can hinder the effectiveness of programme implementation, it also has implications for an 
evaluation - if intended results and impacts are not clearly formulated, it is difficult to assess whether they have been achieved. 
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 these 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 projects 
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 establishment 
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, development and implementation of public health policy initiatives. 
The evidence of such contributions was, however, 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 final reports, and not all final reports are available on-line. 

69

 
Based  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 other 
grounds, e.g. to ensure sustainability. 

The  projects  funded  by  the  PHP  have  also  helped  transmit  experience/best  practices  to  and  from  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 interviewed 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 effort 
to disseminate project results, e.g. through publication of articles, website, training seminars and conferences. In other cases, 
the dissemination efforts have not been targeted to all relevant stakeholders. 

Most of the budget is allocated to calls for proposals. In recent 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 sufficient 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  operating  grants  and  joint  actions.  Time  will  show  whether 
introduction of these new instruments are sufficient to overcome the challenges encountered 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  organisations  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 traditional public health researchers applying for PHP funds seem 
to place less emphasis on aspects such as the link to EU public health policies, implications in terms of national policies and the 
dissemination of project results beyond the narrow circle of experts directly dealing with each topic. In such cases, it must be 
considered  whether  the  PHP  is  ultimately  meant  to  support  evidence-based  developments  at  the  EU  level  or  to  subsidise 
ongoing research activities of the public health community.  

Consistency/complementarity 

1.3.3 
According to the PHP programme decision, consistency and complementary 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  national  or  international  activities  at  programme  and/or  project 
level. 

70

 
Support/involvement 

1.3.4 
The e-survey revealed that most of the stakeholders are familiar with the EU public health policy in general. This also holds for 
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. However, other stakeholders employed by international organisations are 
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 States feel less familiar with this area. This is an important observation as familiarity 
is considered closely associated with involvement.  

Most beneficiaries have met barriers to receiving 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 areas 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 Committee, 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 knowledge 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 found 
as to what extent national interests are taken into account in the implementation of the projects.  

Monitoring 

1.3.5 
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 programme as well as facilitate the subsequent evaluation. 

Progress has been made since the launch of the PHP to ensure that the monitoring system delivers the information needed to 
support  sound  implementation  of  the  programme.  In  our  view,  there  is  still  room  for  improvement.  During  interviews 
conducted as part of the evaluation, 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.   

Sustainability 

1.3.6 
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. However, little evidence has been found of the sustainability of 
project results though policy initiatives, neither at EU nor at national level.  

71

 
No 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 after the EC funding has ended - has been assessed. We believe that 
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  evaluation  dimension.  The  five 
highest ranked recommendations are marked in bold. 

Figure 0-1 

Overview of recommendations in order for each evaluation dimension in order of priority 

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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 areas, bringing them to not more than 15 
per yearly call.  (1st priority) 

DG  SANCO  should  ensure  that  the  priority  areas  in  the  annual  work  plans  are 
focused 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. (4th priority) 

EAHC  should  reveal  gaps  in  the  coverage  of  a  priority  area  by  the  supported 
projects to ensure better coverage in future project funding decisions. 

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 drawing up of the annual work plan. 

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) 

DG SANCO should earmark a part of the budget in the annual work plans as easy 
accessible  funds  towards  additional  dissemination  efforts.  These  should  be 
distributed  based  on  a  separate  'fast  track'  and  simple  application  procedure. 
However, this might require a change in the financial regulation. 

EAHC  should  develop  a  final  report  template  on  outputs/results/impacts  to  be 
used  by  all  beneficiaries  as  a  supplement  to  the  technical  implementation 
report. 

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. 

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. 

EAHC  and  DG  SANCO  should  pursue  inclusion  of  Member  States  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. (5th priority) 

72

 
 
 
 
 
 
 
 
 
 
 
 
 
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information  package  with  relevant  targeted 
EAHC  should  distribute  an 
information about the programme to each Programme Committee and National 
Focal Point members. 

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. 

Each Member State should establish a help desk to provide support to potential 
applicants to overcome barriers relating to funding procedures and reporting. 

EAHC  should  compile  monitoring  reports  on  a  yearly  basis  based  on  common 
management performance indicators. 

EAHC  should  predefine  keywords  for  the  categories  of  interventions,  health 
issues and the target groups. The project applicants must choose the keywords 
which best describe their projects. This improved information about coverage of 
health objectives will enhance both funding decisions and evaluation exercises. 

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 that such 
procedures do not increase the administrative burden for the end user and grant 
holders unnecessarily. (3rd priority)  

Project applicants should e requested by EAHC to include considerations about 
involvement of potential users during project implementation and sustainability 
in their project applications. 

73

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX  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  Health  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 the following three main objectives as per programming documentation: 
(1) Improve citizens’ health security (HS); (2) Promote health and reduce health inequalities (HP); (3) 
Generate and disseminate health information and knowledge (HI). 

•  The interviews with stakeholders (e.g. EAHC officials; Programme Committee members and national 
focal  points;  Policy  Committee  members;  officials  of  other  EU  financial  programmes  and 
representatives  of  International  Organisations)  have  indicated  that  overall,  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 priority areas addressing the main public health issues 
in  Europe,  but  that  more  individual  thematic  areas  close  to  their  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, proven EU added value 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  contribute  to  EU  wide  effects  as  defined  by  the  EAHC,  most 
prominently in the areas of the promotion of best practice (“(...) to grant to all citizens the benefit from 
state of the art best practice, and to ensure the capacity building where necessary”) and professional 
networking  (“(...)  the  priority  expected  results  have  the  objective  to  support  or  create  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 Public 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 resources across the EU and working on joint solutions. 
Without  the  Health  Programme  there  would  be  fewer  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. 

74

 
 
1.1.2  Design 

Scope for efficiency gains by improving the design of HP 

•  Desk  research  has  shown  that  the  funding  of  actions  is  not  spread  equally  over  the  three  main 

objectives of the Health Programme, and is not targeting the priority areas to an equal extent. 

•  According to the stakeholder interviews carried out, important efficiency gains could be achieved by 
reducing  the  number  of  priority  actions  of  the  Health  Programme,  and  by  targeting  them  at  health 
issues that are of most concern to Member States. 

Good utilisation but mixed satisfaction on the new financing mechanisms 

•  Desk  research  has  shown  that  since  the  introduction  of  the  current  Health  Programme,  actions  are 
more widely dispersed among the different financing mechanisms. It also suggests that the range of 
different  financing  mechanisms  are  better  suited  to  accommodate  the  actions  funded,  and  might 
increase the effectiveness of their outputs. 

•  Stakeholders, among them members of the Programme 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 introduction of new financing mechanisms as a very positive development 
in general and highlighted the point that different financing mechanisms fulfil different purposes. 

•  The case study exercise conducted over a number of thematic areas has revealed that, regardless of the 
financing mechanisms actions are funded under, some of the actions assessed face similar challenges 
and limitations  in that  they  lack clear intervention  logics,  definition 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  revealed  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  interviews  undertaken,  the  dissemination  of  results  is  one  of  the  main 
issues  of  the  current  Health  Programme.  Certain  stakeholder  groups,  e.g.  Programme  Committee 
members, feel not sufficiently informed about the results 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 scope 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 individual 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 dissemination by making them available through their own 
publications, ideally in a broad range of languages and specifically targeting relevant stakeholders. 

75

 
1.2. 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  certain  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  achieved  by  the  Programme.  In  conjunction  with  other 
policy  implementation  tools,  appropriate  priority  actions  could  then  be  set,  financing  mechanisms 
selected and an appropriate spread among the objectives and priorities ensured. 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  Executive  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 provide 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; 

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  review  process  and  without  encroaching  on  the  capacity  of  the 
applicants to formulate the evidence base);  

o  assessing potential “EU added value” along clear and quantifiable criteria (as stated above, this 

aspect is crucial and therefore guidance on it should be made very clear); 

o  defining target groups / dissemination 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  assessing  EU  added  value,  developed  as  part  of  this 
evaluation,  might  be  considered  a  starting  point  for  the  future  assessment  of  EU  added  value  in 
proposals.  Applicants  could  provide  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 dissemination, 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.  the  Public  Health  website,  DG  SANCO  publications, 
newsletter  etc.  In  order  to  reach  national  policy  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  disseminate  information  to  the  European  Parliament  and  the 
Committee of the Regions to promote the application of results at the regional / local level. 

76

 
 
 
 
2. 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 was endowed with a total budget of 321.5 
million Euros to be allocated to projects that could complement, support and add value to national health 
policies. In this context, projects were expected to include and involve actors from different participating 
Member States and their results should be applicable to other countries and regions across Europe and in 
its neighbourhood. 

The purpose of the mid-term evaluation was to assess 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  specifically,  the  Tender  Specifications  requested  that  the 
evaluation: 

1.  Provide  an  overview  of  the  implementation  of  the  Health  Programme  in  the  first  three  years, 
including a quantitative and qualitative description of the priorities set, the financial mechanisms 
used (e.g. operating grants, joint actions, tenders etc), the beneficiaries 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 deliverables 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 financial programmes funded 

from the EU budget, instruments and funds, and the utility of the Health Programme. 

4.  Measure the progress made in the light of the recommendations 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 evaluators developed a methodology primarily based on: 

•  an  in-depth  analysis  of  a  sample  of  actions  funded  under  the  Health  Programme,  to  assess  their 
relevance,  effectiveness,  efficiency,  utility,  and  their  contribution  to  fulfilling  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  funded  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,  particularly  examining  the  Programme’s  Intervention 

Logic and it’s consistency and complementarity with other EU Programmes. 

44 

 Official Journal L 301 of 20.11.2007, pp. 3-13.  

77

 
                                                 
The  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), design (the plan that establishes a relationship between programme 
objectives  and  resources)  and  management  (the  practical  organisation  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 lacks a clear intervention logic. The intervention logic 
could be improved by better determining and describing: 1. the overall goals of the Programme, 2. how 
those goals might be reached, and 3. how progress can be accurately and effectively measured against the 
goals. 

Process in place for determining priorities in AWPs 

There  is  a  process  in  place  for  determining  priorities  in  the  Annual  Work  Programme  (AWPs)  and  for 
ensuring their alignment with the overall objectives of the Health Programme. However, this process is 
not  considered  as  particularly  clear  or  consistent.  Public  health  officials  from  different  parts  of  DG 
SANCO do not all employ the same process for determining priorities. There is no overarching systematic 
approach defined for this. In addition, setting priorities in the AWPs has not fully 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 and all contribute to the priority-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 which applicants have 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 which actions’ results achieve 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 cases there appears to be little deviation to what is detailed in proposals 
in terms of action outputs and outcomes. 

HP actions contribute to EU wide effects 

The  majority  of  actions  funded  under  the  Health  Programme  have  contributed  to  EU  wide  effects  to  a 
great extent when taking into account the seven ways of which to assess 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  “promotion  of  best  practice”  and  “networking”,  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 being able to quantify this effectively and accurately. 
In addition, it is envisaged that the results of many actions will be carefully examined and potentially used 

78

 
 
when  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 diverse range of health-related activities. 

Design 

Scope for efficiency gains by improving the design of HP 

Efficiency  gains  could  be  achieved  by  reducing  the  number  of  priorities  and  targeting  them  at  health 
issues that are of most concern to Member States and where there is real value identified at intervening at 
EU level. Determining the potential “EU added 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 too early to say if some financial instruments have led 
to  more  effective  outputs  than  others.  Several  actions  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  logic,  target  audiences,  the  dissemination  strategy  of 
deliverables and the “EU added value” of the action. 

Selection process seems to ensure selection of appropriate/competent applicants 

The  selection  process  of  actions  funded  under  the  Health  Programme  is  strengthened  in  ensuring  that 
appropriate  and  competent  applicants  are  selected  for  funding.  However,  while  in  theory  the  current 
process offers equal access for all organisations to the Programme, consortia made up of “tried and tested” 
organisations seem to be more likely to be awarded funding than those that are small / new to the process. 
The  EAHC  is  aware  of  this  problem  and  has  taken  steps  to  support  smaller  organisations  in  their 
application  process,  i.e.  by  developing  a  series  of  seminars  introducing  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  financial  or  human  resources  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  complementarity  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  Health  Programme  are  follow-on  actions  from  previous 
interventions funded through the EU. Actions also often use or build on the results of interventions funded 
under the Research Framework Programmes or the previous Health Programme. It is therefore necessary 
to share data more effectively between actions funded under the Health Programme and similar activities 
at national, European and international level, as well as between DG SANCO and other DGs, in order to 
create synergies and to better identify overlaps. 

79

 
Management 

Outsourcing of HP management to EAHC has significantly improved delivery 

The outsourcing of the management of the Health Programme 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  design  of  proposals,  the  running  of  actions  and  the 
dissemination  of  results.  However,  the  work  load  of  individual  EAHC  project  officers  is  high,  and 
providing more support at the current staffing levels would be a challenge. 

Scope for improvement of monitoring / management of HP 

The EAHC also takes responsibility for monitoring and 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 stakeholders. 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 results, particularly when an action has come to an end. 
The  dissemination  of  results  at  national  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 SANCO looks to refine the objectives of the Health Programme for 
them to be more tangible and focussed on certain public health issues, especially those that are difficult 
for  Member  States  to  reach  individually,  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 complement 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. 

80

 
 
DG SANCO to develop a plan for long-term targets 

To  ensure  an  effective  implementation  of  the  Health  Programme,  it  is  recommended  that  DG  SANCO 
develops a plan for long-term targets to be achieved 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  and  provide  a  rationale  / 
justification behind varying levels of funding for each objective. 

Consult national health experts 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  action  leaders  on  their  experiences  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 priority areas in the AWPs as well as the overall HP objectives should 
be retained. DG SANCO officials should continue assessing proposals according to their policy relevance, 
and external evaluators should continue rating proposals according to their evidence base. 

EU added value of actions should feature to a greater extent in the application process 

The  EU  added  value  of  actions  should  feature  to  a  greater  extent  in  the  application  process.  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 assessing EU added value, developed as part of this evaluation, might be considered 
a starting point for the future assessment of EU added value in proposals. Applicants could provide a self-
assessment of EU added value which would be assessed and validated during the evaluation process. 

Management 

EAHC to monitor organisations applying for funding 

The  EAHC  should  continue  undertaking  satisfaction  surveys  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 equal access for all applicants to receive funding in the future. 

The  EAHC  should  also  carry  out  a  more  in-depth  assessment  of  a  sample  of  actions  every  year,  for 
example  in  a  case  study  format  similar  to  the  one  undertaken  for  this  evaluation.  This  would  enable 
project officers to develop a more in-depth assessment of actions funded, but also to have data available to 
publish and further disseminate among stakeholders involved or interested in the Health Programme. 

81

 
DG SANCO / EAHC to provide clearer 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 (definitions and very clear examples of 
Inputs, Outputs, Results, Outcomes and Impacts of an action); 

•  setting indicators that could provide 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  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 review 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 therefore guidance 

on it should be made very clear); 

•  defining target groups / dissemination plans / evaluation plans. 

Actions and their results need to be built into a regular reporting system 

In  order  to  ensure  the  dissemination  of  results  by  actions  themselves,  the  evaluation  recommends  that 
actions  allocate  parts  of  the  EC  funding  to  dissemination,  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. the Public Health website, DG SANCO publications, newsletter etc. 

In order to reach national policy 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 
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  consistencies  and  complementarities  of  HP  actions  with  other  actions  at 
international, European and national level, it is recommended that data is shared more. 

82

 
 
 
ANNEX 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 

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 operational experience 
and exchanging expertise and 
knowledge (the case of DETERMINE 
project) 

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 

Main orientations:  

Main orientations:  

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, active 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).  

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 

83

that 

The  Forum 
is 
reasserted 
fundamental to have a PHP, especially 
for  patients,  and 
to  support  health 
literacy  and  the  fight  against  health 
inequalities. 

it 

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.  

 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Future Health Programme:  

Other health topics:  

Other health topics:  

Other health topics:  

evidence  based  policy 

further develop actions to  
•  enhance dynamic health systems, 
•  support 
making,  
•  be  an 
to  support  the 
exchange  of  experiences  and  practices 
creation  of  knowledge 
the 
and 
resources,  and 
•  support research and actions related 
to professional and patient mobility. 

instrument 

The  EU  Health  Programme  should  be 
maintained  and  developed  further,  in 
order to  
• 

the  establishment, 
support 
extension  and  operation  of 
EU-wide networks, and  
emphasise  EU-wide  activities 
in 
areas, 
including  research  support  in 
decision making.  

priority 

key 

• 

• 

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. 

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 
the 
as 
aspects 
as 
environment, housing and transport. 

other 

such 

Sustainability  &  Health 
reform (PL, MT, PT, CZ, HU) 

systems 

ageing  & 

Healthy 
Innovation 
Partnership,  old  people,  dementia  (FI, 
MT, CZ, IT, HU) 

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, FI, DK, PT) 

Health inequalities (LT, PL, SE, UK) 

Inter-sectoral  links  (FI)  &  especially 
use  of  structural  funds  in  health  (MT, 
SK, HU, CZ) 

Health  in  all  policies  (ES,  PL,  PT,  SE, 
UK)  

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) 

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 
(FI, IE, IT, LT, NL, PL) 

in  Health  Technology 

e-health (IT, NL, PT) 

 Health indicators (IT) 

84

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 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 

Commission directive 
2005/61/EC 

Commission directive 
2005/62/EC 

Commission directive 
2004/33/EC 

ORGANS 

Directive 2010/45/EU of the 
European Parliament and 
the Council 

TISSUES AND CELLS 

Directive 2004/23/EC of the 
European Parliament and 
the Council 

Commission directive 
2006/86/EC 

Commission directive 
2006/17/EC 

27.01.2003

OJ L 33 
08.02.2003

30.09.2005

OJ L 256 
01.10.2005

30.09.2005

OJ L 256 
01.10.2005

22.03.2004

OJ L 91 
30.03.2004

07.07.2010

OJ L 102 
06.08.2010

31.03.2004

OJ L 102 
07.04.2004

24.10.2006
OJ L 294 
25.10.2006

08.02.2006

OJ L 38 
09.02.2006

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 

Having 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 

implementing 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 

implementing Directive 2002/98/EC of the European Parliament 
and of the Council as regards certain technical requirements for 
blood and blood components 

on standards of quality and safety of human organs intended for 
transplantation. 

on setting standards of quality and safety for the donation, 
procurement, testing, processing, preservation, storage and 
distribution of human tissues and cells. 

implementing 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 
implementing 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/blood_tissues_organs/key_documents/index_en.htm#anchor3 

85

 
 
 
 
 
 
 
 
NUMBER 

DATE 

TITLE 

ART. 168 - COMMUNICABLE DISEASES 

Decision No 2119/98/EC of 
the European Parliament 
and the Council 

Commission Decision 
2000/57/EC  

Commission Decision 
2000/96/EC  

Commission Decision 
2002/253/EC  

Regulation (EC) 
No851/2004 of the 
European Parliament and of 
the Council  

Health Security initiative 

24.09.1998
OJ L 268/1
03.10.1998 

22.12.1999
OJ L 21/32; 
26.01.2000

22.12.1999
OJ L 28/50 
03.02.2000

19.03.2002
OJ L 86/44; 
03.04.2002
21.04.2004
OJ L 142/1; 
30.04.2004

setting up a network for the epidemiological surveillance and 
control of communicable diseases in the Community 

on the early warning and response system for the prevention 
and control of communicable diseases under Decision No 
2119/98/EC of the European Parliament and of the Council. 

on 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 

laying 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 

Establishing a European Centre for Disease and Prevention 
and Control 

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 structures 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_diseases/key_documents/index_en.htm#anchor1 

ART. 168 - SCIENTIFIC COMMITTEES 

Commission decision 
2010/309/EU 

Commission Decision 
2009/566/EC 

Commission Decision 
2009/146/EC 

Commission Decision 
2008/721/EC 

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. 

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  

19.02.2009 on the appointment of the members and advisors of the 

Scientific Committees and the Pool set up by 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  

86

 
 
 
 
 
 
 
 
 
 
NUMBER 

DATE 

TITLE 

ART. 114 - TOBACCO 

Directive 2001/37/EC of the 
European Parliament and 
the Council 

Directive 2003/33/EC of the 
European Parliament and 
the Council 

Revision of the Tobacco 
Products Directive 
2001/37/EC concerning the 
manufacture, presentation 
and sale 

05.06.2001

OJ L 194 
18.07.2001

26.05.2003

OJ L 152 
20.06.2003

on the approximation of the laws, regulations and administrative 
provisions of the Member States concerning the manufacture, 
presentation and sale of tobacco products 

on the approximation of the laws, regulations and administrative 
provisions of the Member States relating to the advertising and 
sponsorship of tobacco products. 

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, for 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 

Commission Regulation 
(EC) No 658/2007 

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.  

14.06.2007 concerning financial penalties for infringement of certain 

Council Regulation 
EC/297/95  

Commission Regulation 
(EC) No 1234/2008 

10.02.1995
OJ L 35, 
15.02.1995

24.11. 2008

obligations in connection with marketing authorisations granted 
under Regulation (EC) No 726/2004 of the European 
Parliament and of the Council 

on fees payable to the European Agency for the Evaluation of 
Medicinal Products  

concerning 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 

Regulation (EC) No 
141/2000 of the European 
Parliament and of the 
Council 

Regulation (EC) No 
1901/2006 of the European 
Parliament and of the 
Council  

Regulation (EC) No 
1394/2007 of the European 
Parliament and of the 
Council  

6.11.2001 on  the  Community  code  relating  to  medicinal  products  for 

human use 

16.12.1999 on orphan medicinal products 

12.12.2006 on medicinal products for paediatric use and amending 

Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 
2001/83/EC and Regulation (EC) No 726/2004 

13.11.2007 on advanced therapy medicinal products and amending 
Directive 2001/83/EC and regulation (EC) No 726/2004 

87

 
 
 
 
 
NUMBER 

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 

Regulation (EC) No 
470/2009 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 

Proposal for a revision of 
the Directive on veterinary 
pharmaceutical legislation 

06.11.2001 on the Community code relating to veterinary medicinal 

products 

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 Directive 2001/82/EC of the 
European Parliament and of the Council and Regulation (EC) 
No 726/2004 of the European Parliament and of the Council 

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 administrative delays, overcoming divergent 
decisions throughout the EU and streamlining of reporting 
procedures 

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/documents/eudralex/vol-1/index_en.htm 

      VETERINARY: http://ec.europa.eu/health/documents/eudralex/vol-5/index_en.htm 

ART. 114 – MEDICAL DEVICES 

Directive 90/385/EC of the 
European Parliament and of 
the Council 

Directive 93/42/EC of the 
European Parliament and of 
the Council 

Directive 98/79/EC of the 
European Parliament and of 
the Council 

Directive 2007/47/EC of the 
European Parliament and of 
the Council 

20.06.1990
OJ L 189
20.07.1990

14.06.1993
OJ L 169
12.07.1993

27.10.1998
OJ L 331
07.12.1998

05.07.2010
OJ L 247
21.09.2007

on the approximation of the laws of the Member States relating 
to active implantable medical devices 

concerning medical devices 

on in vitro diagnostic medical devices 

amending Council Directive 90/385/EEC on the approximation 
of the laws of the Member States; relating to active implantable 
medical devices, Council Directive 93/42/EEC concerning 
medical; devices and Directive 98/8/EC concerning the placing 
of biocidal products on the market 

88

 
 
 
NUMBER 

DATE 

TITLE 

ART. 114 – MEDICAL DEVICES 

Commission decision 
2010/227/EU 

Proposal for a Directive 
concerning medical devices 
and repealing Directives 
90/385/ECC and 93/42/ECC 

Directive concerning in vitro 
diagnostic medical devices 
and repealing Directive 
98/79/EC 

19.04.2010
OJ L 102
23.04.2010

 on the European Databank on Medical Devices (Eudamed) 

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. 

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, for the other legislation in relation with medical devices 
please see: http://ec.europa.eu/health/medical-devices/documents/index_en.htm  

89

 
 
 
 
 
ANNEX 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 continued in the framework of the Health for Growth 
Programme proposal (see table below). Each of the 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  the  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  the  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 centred 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 state action in the same area; (d). The EU added 
value  of  the  co-funded  actions.  These  questions  relate  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  was  checked  through  a  review  of  the  following 
issues:  (a).  Review  of  activities,  results  and  outputs;  (b).Identification  of  target  groups;  (c). 
Analysis  of  project  impact,  both  expected  and  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  logic  of  the  actions  under 
review, as well as lessons learnt and considerations for future improvement.  

→ HTA 

Case studies 

Specific objectives 
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 
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 
3. Develop shared guidelines for health care 
quality, transparency and patient safety 
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 
5. develop common approaches and demonstrate  → Reference laboratories for highly pathogenic 

→ Pilot European Reference Networks on Rare 
Diseases/ possibility of extrapolation to non-rare 
disease networks 
→ ORPHANET 

→ Cancer prevention and control, incl. cancer 
screening 
→ Supporting HIV/AIDS prevention 

90

 
 
their 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 transplantation in Europe 

91

 
 
 
CASE STUDY N°1: Health Technology Assessment (HTA) 

Health problem under scrutiny 

° 

Improving cost-effectiveness of health 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 (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: 

(cid:190)  support cooperation between national authorities or bodies; 
(cid:190)  support Member States in the provision of objective, reliable, timely, transparent, comparable 
and  transferable  information  on  the  relative  efficacy  as  well  as  on  the  short-  and  long-term 
effectiveness, when applicable, of health technologies and to enable an effective exchange of 
this information between the national authorities or bodies; 

(cid:190)  support the analysis of the nature and type of information that can be exchanged; 
(cid:190)  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 differs 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  basis  for  assessing  health  technologies  (a  so-called 

"core HTA model"), as well as tools for effective interaction and cooperation; 

°  Exploration of  feasible working methods for cooperative assessment work; 

°  Development of common guidelines to streamline HTA 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  methods  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; 

92

 
 
 
 
 
° 

Increasing the capacity of stakeholders to be actively part of the HTA process; particularly health 
professionals and patients' organisations. 

°  Standardising requirements for the pharmaceutical industry 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 national/regional HTAs used for policy decisions. 

Activities (2006-2013) 

°  Establishment  of  a  European  HTA  network  (EUnetHTA)  and  development  of  a  generic  "core 

HTA model" and related tools including adaptability to different technologies. 

°  Testing  of  adapted  versions  of  the  "core  HTA  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  number  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 the 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  basis  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  general  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 treatments or interventions, incl. the cost element. 

93

 
 
 
 
 
Within these groups it is important to differentiate between the following categories: 

°  Potential (the wider community of experts, healthcare 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 effectively reached during the duration of the action). 

Impact can be strengthened every time we cross another level. 

Expected impact 

The  nature  of  the  actions  so  far  implemented  (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 have 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 participants 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 duplication 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 innovative 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 responsible 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  establishment  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 limited 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. 

94

 
 
 
 
 
 
Other 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  necessary  to  jointly  produce  HTA  studies;  to  what 
extent  HTA  information  has  been  used  at  national  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 rather "appraisals" than "assessments", since most 
of the evidence is already produced by the pharmaceutical company. At an average cost of 20 000 
€, and with 15 MS making them in parallel, total 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  contribute  to  standardised  requirements  for 
industry which would increase transparency and predictability, with additional financial benefit. 

45 Up to 50 such products are given Market Authorisation through the centralised EMA procedure in Europe annually, and 
Directive  89/105/EEC  (the  transparency  directive)  requires  MS  to  take  a  decision  on  pricing  and  reimbursement  of  these 
products within 90/180 days.  

95

 
                                                 
 
CASE STUDY 2: Pilot European Reference Networks (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  patients,  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  ultimately,  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 potential 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 prevention, 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  (CBHC)  directive  2011/24EU  (includes  Rare  Diseases 
under arts. 12 and 13).  

°  Support  the  policies  and  initiatives  of  MS  in  the  following  areas:  recognition  of  RD;  research; 
development  of  national  plans  and  strategies;  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 health 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 have been funded – although diverse, they share key characteristics, 
including main and specific objectives: 

Main objective: 

Share expertise and resources to improve the access and 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 the development of generic and 
not RD specific criteria for ERNs. 

96

 
 
 
 
 
                                                 
° 

Improving clinical research 

EU added value 

Principal type of EU added value: 

°  Generation/translation/validation/dissemination 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-of-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  improving  quality  of  diagnosis,  care  or  QoLife,  incl. 

Quality Assurance scheme for labs, clinical guidelines or central diagnostic capacities 

°  Dissemination  of  information  to  healthcare  professionals  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 biological diagnosis and disease-specific information; 

°  Training tools and sessions, both for healthcare professionals and patients; 

Target groups 

Two are the main target groups of the work of the 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, enabling 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 differentiate 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 effectively reached during the duration of the action). 

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Impact can be strengthened every time we cross another level. 

Expected impact 

Taking into account the nature of the action, i.e. collection 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 specific 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 healthcare 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 expected 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  lead  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 judged 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 after 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 and continuous updating of the information and tools developed in 
the  initial  phases  are,  together  with  the  necessary  outreach  to  new  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. designation of centres) provide the necessary framework 
of action and funding for the centres of expertise making up the pilot ERNs. The activities of the 
networks  come  on  top  of  the  regular, clinical work  these  centres  undertake  in  the  framework  of 
their national health system. 

°  The pilot ERNs develop the collaborative tools and 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 

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°  The  objectives,  structure,  activities  and  outputs  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 order 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  concerns  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  (and  urgent)  to  look  at  alternative  approaches  in 
sharing of costs between MS and ensuring funding 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 ORPHANET and EURORDIS, to provide "services for a 
fee", supporting the setup of new networks, with a much lower cost. 

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1.1. 

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 morbidity, premature mortality, loss of Quality 
of  Life  (QoL),  with  extended  impact  beyond  patients,  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  ultimately,  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 potential 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 prevention, 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 directive 2011/24EU (includes RD under arts. 12and 13).  

°  Support  the  policies  and  initiatives  of  MS  in  the  following  areas:  recognition  of  RD;  research; 
development  of  national  plans  and  strategies;  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 several 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 specifically, 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 rare 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 transition from a project structure based on 

a specific MS's infrastructure, to a truly EU institutional dimension, ensuring sustainability.  

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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,  validated  and  disseminated  centrally,  at  marginal 

cost for MS) 

°  Promotion of best practice (validated state-of-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 classifications, through published articles, 
books and reports from expert groups, as well as indexation of RD with prevalence data, genes and 
clinical  signs  and  cross-referencing  with  ICD10,  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  information  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 clinical guidelines and patient information packages 

Results/outputs 

°  A reference source of information on RD for European citizens and professionals, contributing to 

optimal diagnosis and management of these severe, chronic and debilitating diseases. 

°  Coverage  of  all  of  the  almost  6,000  rare  diseases  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 healthcare managers to disseminate 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 provides validated quality knowledge to empower 

them to improve their Qof life. 

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°  Policy  makers  at  EU  and  MS  level  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 professionals/ 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 expressly targeted by the activities of ORPHANET) 

In this case, we have  

°  Reached (those of the previous group effectively 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 has 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 professionals/ experts in the field and improved QoL for 
the patients. There are several indirect ways to measure 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 action 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 

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Sustainability of the dbase depends not only on renewed funding, but also in ensuring current levels 
and quality of coverage in the future, while also adapting 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 and 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 investment 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  outputs  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 reference 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  impact  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  transforming  the  operational  framework  and  governance  of 
ORPHANET into a truly EU institutional dimension, to also include adequate funding component. 

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CASE 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. Scientific 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).  Providing  a  framework  for  identifying  and  sharing 
information, capacity and expertise in cancer prevention 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  healthcare  approaches  in  practice  -  identification  and 
dissemination of good practice; Cooperation and coordination 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 against 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 disseminate good practices; and to provide a framework for 
identifying  and  sharing  information,  capacity  and  expertise  in  cancer  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  prevent  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 the 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  

104

 
 
 
 
 
                                                 
°  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 awareness raising actions all across EU are likely as well. Finally 
the concentration of funding for research is expected 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:  collaboration,  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 guidelines 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  provided  with  evidence-based  tools  (such  as  the 
guidelines), enabling the latter for example, to improve their national prevention programmes. 

105

 
 
 
 
 
°  Healthcare professionals are also specifically targeted, through the sharing of expertise and data. 

°  The EU citizens, those already affected by the disease, as well as those that may be in the future. 

Within these groups it is important to differentiate 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 expressly targeted by the funded activities). 

°  Reached (those of the previous group effectively 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  policy  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 establish 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 essential 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 population at large as target group, but it has several 
weaknesses,  including:  the  difficulty  to  demonstrate  the  exact  role  of  the  programme  in  the 
mortality decrease observed; the difficulty to differentiate the action at EU level and the action at 
MS level. 

Conclusion 

°  The objectives, structure, activities and outputs of the 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 coherent framework for future action.  

°  Funding  in  the  future  should  incorporate  impact  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 differentiate the impact of EU level actions vis a vis 
MS  action.  However  the  following  methods/  indicators  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 screening activities in the EU. The impact 
of the EU action could be identified by, for example, 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 impact and added value of the EU programme. 

106

 
 
 
 
 
° 

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 influence 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 demonstrated 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 various 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  scientific  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  impact  –  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  (national,  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 diagnosis 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 the organisation of the screening activities in the MS 
under comparison. 

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CASE STUDY N°5: Supporting HIV/AIDS prevention in Europe 

Health problem under scrutiny 

°  HIV/ AIDS infection remains of major public health 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 HIV/AIDS and reduce the burden of the disease. 

Means of action: 

°  Legislative  action:  (a).  Commission  Communication  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 coordination between EU countries; (b). Commission 
Decision No 2119/98/EC setting up the epidemiological 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 prevention 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-infections 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 authorities, 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. reducing the burden of the disease by improving HIV/AIDS prevention in 
Europe, will be the subject of a Joint action (planned 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 objectives to prevent and reduce drug use, dependence and drug-
related  harm;  Communication  COM/2009/0567  ‘Solidarity  in  health:  reducing  health  inequalities  in  the  EU,  addressing 
health  inequalities  in  the  Member  States  as  well  as  the  question  of  disparities  in  life  expectancy,  especially  for  vulnerable 
groups. 

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-  To promote the integration of quality assurance (QA) 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 targeting key priority groups, by developing key 

evidence based projects promoting testing 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  defining  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  Programme  funding  have  established  expert 
networks,  bringing  together  Public  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  has  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  professionals  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  areas  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 population groups, ethnic and sexual minorities.  

49  (a).  ENCAP  project  on  HIV/AIDS  prevention  among  Intravenous  Drug  Users  in  the  Baltic  countries;  (b).  ACTIVATE 
(capacity building and Training project in HIV/AIDS Treatment and management across Europe; (c). SIALON Network on 
combined  and  targeted  prevention  on  MSM  population;  (d).EATG  in  promoting  the  availability  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) . 

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°  Health care and social welfare professionals, as first line carers and support for those affected by 

the disease, as well as civil society organisations who are active on HIV/AIDS prevention. 

Within these two groups it is important to differentiate 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 expressly targeted by the funded activities) 

°  Reached (those of the previous group effectively 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  developed  cover  well  defined  thematic  fields  or 
geographical  areas  on  HIV/AIDS  prevention:  although  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  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:  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 the 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 limitation 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  generalised  intervention.  Addiitionally,  targeting  the 
most vulnerable groups with effective prevention means ensuring that the action 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  prevention  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  Action  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 structured so as to ensure impact in their specific 
context and in line with the main and specific objectives which they have set to achieve. Such, is 
for example, the case of SIALON, where the project has succeeded in reaching a very significant 

110

 
 
  
 
part 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  portfolio  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 which adequate resources should then be addressed.  

Other considerations for the future 

°  The potential of tackling HIV/AIDS and its co-infections in Europe is high. Additionally, there is 
sufficient evidence of effective methods to stop the transmission of the infection and Europe has 
the expertise developed after more than 30 years of public health programmes and policies. 

°  However,  the  present  programme  proposal  should  prioritize  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  transmission  (MTCT)  in  Europe  can  be  achieved  with 
relatively low investments on antenatal screening and 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  testing  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. 

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CASE STUDY N°6: Reference Laboratories for highly pathogenic agents (JA QUANDHIP)50 

Health problem under scrutiny 

°  Europe is facing continuous threats 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 for 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: 

(cid:190) 

(cid:190) 

(cid:190) 

Commission Decision No 2119/98/EC setting up the epidemiological surveillance and control 

of communicable diseases.  

Commission Communication (2009)0273on Strengthening Chemical, Biological, Radiological 

and Nuclear Security in the European Union - an EU CBRN Action Plan 

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  respond  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 Assurance 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 infrastructure, containment, and operational  bio-safety 
and bio-security; and develop standards operating procedures to support 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  Networking  on  the  Detection  of  Highly  Infectious  Pathogens 
(QUANDHIP) Joint action, which is an innovative initiative bridging frontline responders and the specialised (ENP4Lab) and 
(EQADeBa) networks, involving 33 laboratories from 21 EU MS.  

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°  Economies  of  scale:  the  development  of  the  European  laboratories  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  methodologies  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, particularly on laboratory preparedness (GHSAG -LN). 

Activities 

QUANDHIP JA builds on previous levels of collaboration, as follows: 

°  The  EQADeBa  project  (Establishment  of  Quality  assurances  for  detection  of  highly  pathogenic 
bacteria  of  potential  bioterrorism  risk),  developed  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 levels 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  laboratories,  applied  by  Instrument  of  Stability  from 

DEVCO. 

Target groups 

Three are the main target groups: 

°  MS authorities, with responsibility in implementing health protection policies and procedures and 
more specifically the laboratories themselves as key actors for the organization of the response. 

°  Laboratory workers dealing with high threat pathogens, 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 outbreaks and non-natural release of highly infectious 

pathogens.   

Within these three groups it is important to differentiate between the following categories: 

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°  Potential (the wider community of healthcare professionals/ 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 effectively reached during the duration of the action). 

Impact can be strengthened every 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 growing order of importance): 

°  Part  of  the  area  of  diagnostic  capacity  for  highly  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  terms  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  positively  affect  the  level  of  impact  to  the  European 
frontline  responders;  to  other  categories  with  occupational  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  quality  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 response 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 laboratories 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

114

 
 
 
 
 
CASE 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  events  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 identification 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  communications  (2003/545  and  2006/5520),  followed  by 
Council conclusions (30/11-1/12/2006): the Commission 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 departing from ports; (c). Decision No 2119/98/EC setting 
up the epidemiological surveillance and control of communicable diseases (annex I incl. diseases 
covered by the international health regulations and other 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 integrated 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 national 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  exchange  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 for parties to assess and develop 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 functioning 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  Health  Security  Committee  to  support  the  Council  in  achieving  a 
coherent  approach  to  the  preparedness  for  and  response  to  health  threats  and  especially  public  health  emergencies  of 
international concern as defined in IHR 2005;  

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° 

Implementation  of  legislation:  supporting  the  EU  MS  to  acquire  the  core  capacities  for  the 
implementation of the International 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  tool  for  supporting  the  implementation  of  IHR 
2005, involving a multidisciplinary group of experts, strengthening cooperation between different 
sectors, national and international organisations.  

Activities 

The  EU  health  Programme  has  funded  several  actions  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 relevant to support the EU MS acquisition of the core 

capacities for the implementation of the IHR 2005. 

°  The  SHIPSAN  project  has  developed  the  European  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  concept  for  future  collaboration  in  Cross-border 
epidemic  intelligence,  Vaccine  preventable  diseases  and  migrants,  Cross-border  emerging 
zoonoses and Training in applied epidemiology, and developing the Mediterranean network.  

°  The  EpiSouth+  is  working  on  the  establishment  of  the  Mediterranean  regional  laboratories 

network, development of generic preparedness plan and risk management procedures. 

Target groups 

Three are the main target groups: 

°  MS authorities and decision makers, with responsibility 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); experts and public health professionals 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 professionals/ 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 effectively reached during the duration of the action). 

Impact can be strengthened every time we cross another level. 

53 SHIPSAN, SHIPSAN II, REACT, EpiSouth, EpiSouth+ 

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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 effectively 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 thematic (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  dissemination  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: the 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 will 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 strengthening of core capacities and the development of 
a  coordinated  public  health  culture  of  risk  assessment  and  risk  management  of  hazards  events. 
However,  it  is  difficult  to  establish  the  causality  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  fostering  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 the 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  comprehensive  manner  the  entire  thematic  area  and  its 
deliverables are directly linked to reporting formalities 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 have set to achieve; however, it is more difficult 

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to establish the causality link between the implementation 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  useful  for  the  development  of  the  cargo  ships 
manual  and  inspection  programme  covering  chemical  hazards  what  will  increase  the  EU  added 
value  by  the  development  of  the  risk  assessment  tools  for  chemical  threats  in  the  cargo 
transportation in Europe and the definition of measures 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  effectively  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  restricted  thematic  or  geographical  focus  of  the 

networks and the need to streamline them in a more structured, long term framework. 

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CSE 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  question  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 tackled 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  able  to  cross  borders  without 
unnecessary problems and delays. Inconsistent safety and 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  origin  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 
(b).  Commission  Action  Plan  on  Organ  Donation  and 

intended 
Transplantation, strengthened cooperation between Member States (COM (2008 819/3)) 

transplantation; 

for 

°  Support projects and joint actions that help Member States to develop common knowledge, share 
experience and expertise, identify and share good practices, identify and foster cooperation in the 
overall area of organ donation and transplantation. 

MS action in the same area 

°  The concrete organisation of donation 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 diverse, they share key characteristics, including main 

and specific objectives: 

Main objective: 

Support  MS  in  their  efforts  to  achieve  a  consistent  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 practices to increase organs from deceased donors, as 
well as to obtain organs from living donors; 

°  Fostering cooperation and supporting exchange of know-how and capacity building activities; 

EU added value 

Principal type of EU added value: 

° 

Implementing different aspects of EU legislation on safety and quality of organs  

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Additional 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 registries 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:  

(cid:190) 

(cid:190) 

firstly in Directive 2010/53/EU and the (planned) implementing legislation 

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  good  practices  to  increase  organs  from  deceased 
donors. 

Identification, documentation and sharing of good practices to obtain organs from living donors. 

°  Expert visits, exchanging of know-how between national experts. 

°  Establish cooperation between different 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 organisational set-up and training programmes; 

°  Exchange of expertise and knowledge, especially 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  and  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:  

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°  Policy  makers:  specifically  national  competent  authorities  and  all  institutions/  organizations  

involved in coordinating and overseeing activities within a MS; 

°  Healthcare  professionals  and  other  experts 

related  areas: 
procurement/donor centres, health professionals active in transplantation, etc. 

the 

in 

transplant  centres, 

°  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 professionals/ other experts, authorities and citizens, 

whether targeted by the action(s) or not) 

°  Expected (those of the previous group expressly targeted by the funded activities) 

°  Reached (those of the previous group effectively reached during the duration of the action). 

Impact can be strengthened every 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  addressing  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 linkage 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 objectives of the EU action covered by the actions: The 
portfolio of funded actions ranks highly on this level, 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 effective 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 before and after the action, to include other MS: by measuring the 
degree  of  uptake  of  the  knowledge,  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 authorities is a factor that can lead to a wider 
and more active uptake by MS. 

° 

Impact from the use of the tools and knowledge developed under 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 organs, 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 training, 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 effect 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 will provide a long term framework for action. 

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Is it possible to differentiate the impact of EUfunded actions under review from MS action? 

The  development  of  knowledge,  tools,  manuals,  training  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 taken up in national activities, in particular by national 
competent  authorities.  A  consistent  and  comparable  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 clear 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  authorities  enhances  their  impact  by  ensuring 
transferability: the results of the different funded actions can be expected to be up taken in the MS 
and  contribute  to  the  improvement  of  the  situation  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  indicators  could  facilitate  the  measurement  of 

concrete impact with respect to the projects funded under this topic area. 

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