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

COMMISSION STAFF WORKING PAPER 

Executive summary of impact assessment  
Accompanying the document 
Health for growth programme of EU action in the field of health for the period 2014-
2020 

{COM(2011) 709 final} 
{SEC(2011) 1322 final} 

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

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1. PROBLEM DEFINITION 

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

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

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

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

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

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

As  stated  in  the  European  Commission's  Communication  of  29  June  2011  ‘A  budget  for 
Europe 2020’2  ‘Promoting good health is an  integral part  of the smart and inclusive growth 
objectives of Europe 2020. Keeping people healthy and active for longer has a positive impact 
on productivity and competitiveness. Innovation in healthcare helps take up the challenge of 
sustainability  in  the  sector  in  the  context  of  demographic  change  and  action  to  reduce 
inequalities in health is important to achieve ‘inclusive growth’. 

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

1  Communication  from  the  Commission:  ‘Europe  2020  —  A  strategy  for  smart,  sustainable  and  inclusive 

growth’ COM(2010) 2020 final. 

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

2

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

• 

• 

• 

to work with Member states to protect citizens from cross-border health threats, 

to increase the sustainability of health services, 

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

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

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

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

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

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

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

In the area of health the Member States are under pressure to strike the right balance between 
providing  universal  access  to  high  quality  health  services  and  respecting  budgetary 
constraints. These problems are not necessarily new, but the need to tackle them has become 
more and more urgent, particularly in the current economic climate. The financial crisis has 
further magnified the need to improve cost-effectiveness of national health systems. First and 
foremost it is up to Member States to take direct action at their level. The aim of EU Health 
policy,  as  stated  in  the  Treaty,  is  to  complement  and  support  these  national  policies  and 
encourage cooperation between Member States.  

3

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

The Programme should provide possibilities to build and strengthen cooperation mechanisms 
and coordination processes between Member States with a view to identifying common tools 
and best practices that create synergies. It should bring the biggest EU added value and lead to 
economies  of  scale,  thus  supporting  reforms  under  challenging  circumstances.  There  are 
several  challenges  that  Member  States  and  the  EU  as  a  whole  are  facing  from  the  2020 
perspective and beyond: 

A. Financial sustainability of health systems; 

B. Health workforce shortages; 

  C. Improvements necessary in patient safety; 

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

  E.  Loss  of  best  productive  years  in  much  of  the  population  because  of  the  slow 

increase in healthy life years; 

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

G. Global and cross-border threats. 

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

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

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

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

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

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

4

 
 
 
 
 
 
 
 
• 

improving public health, 

•  preventing physical and mental illness and diseases, 

•  obviating sources of danger to physical and mental health, 

• 

• 

• 

fighting against the major health scourges, 

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

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

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

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

•  promoting health information and education, 

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

•  encouraging  cooperation  between  the  Member  States.  In  particular,  the  second 
subparagraph of Article 168(2) states that ‘The Commission may, in close contact with the 
Member  States,  take  any  useful  initiative  to  promote  such  coordination,  in  particular 
initiatives  aiming  at  the  establishment  of  guidelines  and  indicators,  the  organisation  of 
exchange  of  best  practice,  and  the  preparation  of  the  necessary  elements  for  periodic 
monitoring and evaluation.’ 

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

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

Necessity test 

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

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

3. EU ADDED VALUE 

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

The  value  of  investing  in  preparedness,  prevention  and  coordination  of  measures  on  health 
threats  and  communicable  diseases  at  EU  level  was  clearly  demonstrated  recently  by  the 
H1N1  outbreak  in  2009.  Strengthening  the  capacity  to  manage  serious  cross-border  health 
threats,  along  with  joint  procurement  of  vaccines  against  pandemics,  is  another  area  where 
significant  EU  added  value  can  be  obtained.  Cooperating  on  cross-border  diseases  such  as 

5

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

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

The  Health  Programme  has  developed  and  strengthened  networks  between  European  health 
specialists,  national  and  regional  health  authorities  and  other  stakeholders  who  greatly 
contribute  to  sharing  knowledge  and  building  health  capacity  in  the  EU.  It  has  also  built 
consortia, partnerships and other ways to exchange information and practices across Europe, 
thus  boosting  cooperation  and  the  pace  of  research.  The  outcome  of  the  projects  and  action 
funded by the Health Programme constitute the most effective, if not the only, way to build 
the  evidence  base  for  defining  much  broader  regulatory  policies  (for  instance,  on  cancer, 
Alzheimer’s, rare diseases and health inequalities). 
In the context of the mid-term evaluation of the 2nd Health Programme and based on the in-
depth  analysis  of  the  case  studies  following  EU  added  value  criteria  were  developed  and 
tested regarding concrete funded actions: 

•  Fostering best practice exchange between Member States; 

•  Supporting networks for knowledge sharing or mutual learning; 

•  Addressing cross-border threats to reduce risks and mitigate their consequences; 

•  Addressing certain issues related to the internal market where the EU has substantial 

legitimacy to ensure high-quality solutions across Member States; 

•  Unlocking the potential of innovation in health; 

•  Actions that could lead to a system for benchmarking for decision-making; 

• 

Improving  economies  of  scale  by  avoiding  waste  due  to  duplication  and  optimising 
use of financial resources. 

4. OBJECTIVES OF THE PROGRAMME 

Taking  into  consideration  the  problems  and  context  described  above,  as  well  as  limited 
financial  resources  in  the  coming  years,  the  ‘Health  for  Growth’  Programme  general 
objectives  shall  be  to  work  with  Member  States  to  encourage  innovation  in  healthcare  and 
increase  the  sustainability  of  health  systems,  to  improve  the  health  of  the  EU  citizens  and 
protect them from cross-border health threats. 
.  
The specific objectives underpinning the logic of the Programme are all outcome-oriented and 

6

 
 
put the emphasis on the practical results and their up-take by Member States in their national 
programmes and health policies in order to exert leverage on health action and across  other 
policies and other EU funding programmes:  

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

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

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

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

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

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

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

Improving access to healthcare to all citizens regardless of income, social status, location and 
nationality is a key to bridging the current substantial inequalities in health. All EU citizens 
should  have  access  to  safe  and  high  quality  healthcare  regardless  of  their  circumstances.  

7

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

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

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

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

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

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

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

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

The  right  investments  will  not  only  lead  to  better  health,  but  also  to  longer  and  more 
productive  lives  and  lower  labour  shortages.  If  Europeans  live  in  better  health,  they  will  be 
able to continue contributing to the economy as they grow older - as workers, volunteers and 

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

8

 
 
                                                 
consumers. The expertise of the elderly will also be needed even more in a population with 
low birth rates and lack of skilled labour. 

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

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

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

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

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

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

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

5. POLICY OPTIONS 

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

9

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

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

• 

• 

• 

• 

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

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

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

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

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

• 

• 

• 

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

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

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

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

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

6. COMPARISON OF THE OPTIONS 

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

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

Option 2 would allow taking into account to a certain degree concerns of Member States and 
stakeholders' and it would have leverage on national health policies. However, in the absence 

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of intervention logic, lack of SMART, realistic objectives, with a large number of actions not 
prioritised and no precise indicators to measure the achievements, any kind of impact would 
first be very difficult to assess and then very limited, because not part of a logic. This type of 
programme would not allow to achieve the objectives and it would not take into account the 
recommendations stemming from the past evaluations and audits. 

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

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

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

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

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

7. MONITORING AND EVALUATION 

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

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

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

A  wide  range  of  financial  mechanisms  will  be  used  in  the  Programme:  calls  for  proposals, 
grants for actions with Member States, grants for international organisations, operating grants 
and public procurement contracts. As said in the evaluations, the experience gained from their 

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introduction in the current Health Programme was positive and considered as an improvement 
over the system for the previous Public Health Programme. 
The Programme will be subject to mid-term term and ex-post evaluation. The mid-term 
evaluation will serve the impact assessment exercise for eventual follow-up programme in the 
area of health post-2020. 

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