Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a Health for Growth Programme, the third multi-annual programme of EU action in the field of health for the period 2014-2020
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 
COM(2011) 709 final 

2011/0339 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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

(Text with EEA relevance) 

{SEC(2011) 1322 final} 
{SEC(2011) 1323 final} 

 
 
  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL  

Health is not just a value in itself - it is also a driver for growth. Only a healthy population can 
achieve  its  full  economic  potential.  The  health  sector  is  driven  by  innovation  and  a  highly 
qualified workforce. Health-related research and development has the potential to reach 0.3% 
of GDP. The healthcare sector is one of the largest in the EU: it accounts for approximately 
10% of the EU’s gross domestic product and employs one in ten workers, with a higher than 
average proportion of workers with tertiary-level education. 

Health therefore plays an important role in the Europe 2020 agenda. In its Communication of 
29  June  2011  ‘A  budget  for  Europe  2020’1  the  Commission  stressed  that  ‘promoting  good 
health  is  an  integral  part  of  the  smart  and  inclusive  growth  objectives  for  Europe  2020. 
Keeping  people  healthy  and  active  for  longer  has  a  positive  impact  on  productivity  and 
competitiveness. Innovation in healthcare helps take up the challenge of sustainability in the 
sector  in  the  context  of  demographic  change’,  and  action  to  reduce  inequalities  in  health  is 
important to achieve ‘inclusive growth’. 

The  proposed  third  programme  of  EU  action  in the  field  of  health  (2014-2020),  ‘Health  for 
Growth’,  strengthens  and  emphasises  the  links  between  economic  growth  and  a  healthy 
population  to  a  greater  extent  than  the  previous  programmes.  The  Programme  is  geared 
towards  actions  with  clear  EU  added  value,  in  line  with  the  Europe  2020  objectives  and 
current policy priorities. 

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

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

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

1 
2 

COM(2011)500 Final. 
COM(2010)2020 Final. 

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and interoperability of e-Health solutions, to improve for example cross-border use of patient 
registers.  

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

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

The general objectives of the Health for Growth Programme shall be to work with Member 
States to encourage innovation in healthcare and increase the sustainability of health systems, 
to improve the health of the EU citizens and protect them from cross-border health threats. 

It  focuses  on  four  specific  objectives  with  a  strong  potential  for  economic  growth  through 
better health:  

(1) 

(2) 

(3) 

(4) 

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

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

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

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

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

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2. 

OBJECTIVES 

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

2.1. 

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

For  many  years,  Member  States  have  been  facing  budget  constraints  with  regard  to  the 
sustainability  of  their  health  budgets,  which  represent  up  to  15%  of  public  expenditure  in 
some Member States3.  

This  is  further  compounded  by  an  ageing  population,  rising  expectations  for  high  quality 
services  and  the  emergence  of  new,  more  effective  but  more  expensive  technologies.  The 
challenges have increased with curbs on public spending in the wake of the financial crisis. 
Evidence4  suggests,  however,  that  effective  health  system  reforms  have  the  potential  to 
contain ‘excess cost growth’, i.e. keep health spending in line with GDP growth. 

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

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

Source: extracted from Eurostat online database in July 2011 ‘General expenditure by function - health 

3 
compared to total’. 2009: 14.63 %; 
http://appsso.eurostat.ec.europa.eu/nui/show.do?dataset=gov_a_exp&lang=en . 
4 

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

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

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

In  this  context,  actions  planned  under  this  objective  aim  for  example  to  foster  European 
cooperation on Health Technology Assessment (HTA) and explore the potential of e-Health 
and ICT for Health, including a dedicated e-Health network and cooperation among electronic 
patient  registries,  as  part  of  the  implementation  of  the  Directive  on  patients'  rights  in  cross 
border  healthcare5.  Actions  will  also  address  shortages  in  the  health  workforce  and  assist 
Member  States  in  reforming  their  health  systems  through  the  pooling  and  strengthening  of 
expertise on technical evaluation of policy action.  

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

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

2.2. 

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

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

5 

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

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inequalities, as well as complement action under other programmes aimed at addressing social 
and regional differences within the EU.  

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

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

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

2.3. 

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

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

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

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

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

This  is  not  just  a  major  health  challenge,  but  also  a  substantial  economic  opportunity.  The 
right investments will lead not only to better health, but also to longer and more productive 
lives  and  lower  labour  shortages.  If  Europeans  live  in  better  health,  they  will  be  able  to 
continue  contributing  to  the  economy  as  they  grow  older,  as  workers,  volunteers  and 

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

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

2.4. 

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

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

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

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

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

3. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

3.1. 

Consultation and expert advice 

The consultation targeted in particular Member States' representatives, National Focal Points, 
the Council working party on Public health at Senior Level and the informal Health Council. 
Additional  expert  advice  was  provided  through  the  EU  Health  Policy  Forum,  health 

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professionals  and  patients  associations.  Other  programme  stakeholders,  especially 
beneficiaries, have expressed their views in the recent programme evaluations.  

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

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

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

3.2. 

Impact Assessment 

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

• 

• 

• 

• 

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

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

supporting solutions for cross-border health threats;  

supporting actions required by the current EU legal obligations. 

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

3.3. 

Delivering European added value 

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

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

3.4. 

Increasing the performance of the programme 

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

(2008-2013), 

line  with 

in 

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

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

• 

• 

• 

• 

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

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

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

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

Simplification 

The  revision  of  the  Financial  Regulation  will  contribute  to  facilitate  participation  in  EU 
programmes,  for  example  by  simplifying  rules,  reducing  the  costs  of  participation, 
accelerating  award  procedures  and  providing  a  "one-stop  shop"  to  make  it  easier  for 
beneficiaries  to  access  EU  funding.  The  Programme  will  make  a  maximum  use  of  the 
provisions  of  the  revised  EU  Financial  Regulation,  in  particular  by  further  simplifying 
reporting requirements, including a more extensive use of online reporting. 

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

1.  The  level  of  Union  co-financing  for  grants  for  actions,  actions  co-financed  by  the 
competent authorities of the Member States or third countries, or by non-governmental bodies 

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mandated  by  these  authorities  and  operating  grants  will  be  harmonised  at  60%  of  eligible 
costs and up to 80% in cases of exceptional utility. 

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

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

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

4. 

LEGAL ELEMENTS OF THE PROPOSAL 

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

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

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

5. 

BUDGETARY IMPLICATION  

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

the  proposed  budget  allocation  for 

the  Health  Programme 

in 

to 

EN 

10 

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2011/0339 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

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

Having regard to the proposal from the European Commission, 

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

Having regard to the opinion of the European Economic and Social Committee6, 

Having regard to the opinion of the Committee of the Regions7,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

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

(2) Continued effort is required in order to meet the requirements set out in Article 168 of the 
Treaty.  Promoting  good  health  at  EU  level  is  an  integral  part  of  the  ‘Europe  2020:  A 
European Strategy for smart, sustainable and inclusive growth’8. Keeping people healthy and 
active  for  longer  will  have  positive  overall  health  effects,  and  a  positive  impact  on 
productivity and competitiveness, while reducing pressures on national budgets. Innovation in 
health helps take up the challenge of sustainability in the sector in the context of demographic 

6 
7 
8 

OJ C , , p. . 
OJ C , , p. . 
Communication from the Commission, COM (2010) 2020 final 

EN 

11 

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change, and action to reduce inequalities in health is important to achieve ‘inclusive growth’. 
It  is  appropriate  in  this  context  to  establish  a  ‘Health  for  Growth’  Programme,  the  third 
programme of EU action on health (2014-2020) (hereinafter referred to as ‘the Programme’). 

(3) The previous programmes of Community action in the field of public health (2003-2008) 
and in the field of health (2008-2013), adopted respectively by Decisions Nos 1786/2002/EC9 
and  1350/2007/EC  of  the  European  Parliament  and  of  the  Council10,  have  been  positively 
assessed  as  delivering  a  number  of  important  developments  and  improvements.  The  new 
programme  should  build  on  the  achievements  of  the  previous  ones.  It  should  also  take  into 
account the recommendations of the external audits and evaluations carried out, in particular 
recommendations of the Court of Auditors11, according to which "for the period after 2013, 
the  European  Parliament,  the  Council  and  the  Commission  should  reconsider  the  scope  for 
EU public health activities and the approach of EU funding in this area. This should be done 
bearing  in  mind  the  budgetary  means  available  and  the  existence  of  other  cooperation 
mechanisms  (…)  as  a  means  of  facilitating  collaboration  and  the  exchange  of  information 
among stakeholders throughout Europe". 

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

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

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

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

9 
10 
11 

OJ L 271, 9.10.2002, p. 1-12 
OJ L 301, 20.11.2007, p. 3-13 
Court  of  Auditor's  Special  Report  n°212009  of  5.3.2009,  "The  European  Union's  Public  Health 
Programme (2003-2007): an effective way to improve health?" 

EN 

12 

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

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

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

(11) To minimise the public health consequences of cross-border health threats which could 
range  from  mass  contamination  caused  by  chemical  incidents  to  pandemics,  like  those 
unleashed  recently  by  E  coli,  influenza  strain  H1N1  or  SARS  (severe  acute  respiratory 
syndrome),  the  Programme  should  contribute  to  the  creation  and  maintenance  of  robust 
mechanisms and tools to detect, assess and manage major cross-border health threats.. Due to 
the nature of these threats, the Programme should support coordinated public health measures 
at  EU  level  to  address  different  aspects,  building  on  preparedness  and  response  planning, 
robust  and  reliable  risk  assessment  and  a  strong  risk  and  crisis  management  framework.  In 
this context, it is important that the programme should benefit from complementarity with the 
work  programme  of  the  European  Centre  for  Disease  Prevention  and  Control12  in  the  fight 
against communicable diseases and the activities supported under the Unions programmes for 
research  and  innovation.  Special  efforts  should  be  undertaken  to  ensure  coherence  and 
synergies between the Programme and global health work carried out under other Community 
programmes  and  instruments  that  address  in  particular  the  areas  of  influenza,  HIV/AIDS, 
tuberculosis  and  other  cross-border  health  threats  in  third  countries.  Action  under  the 
programme may also cover cross-border threats to health caused by biological and chemical 
incidents, environment and climate change. As stated in the Commission's Communication "A 
Budget for Europe 2020", the Commission has committed to mainstreaming climate change 
into  overall  Union  spending  programmes  and  to  direct  at  least  20%  of  the  Union  budget  to 
climate-related objectives. Spending in the Health for Growth Programme under objective 4 
will contribute in a general manner to this objective by addressing health threats associated to 
climate  change.  The  Commission  will  provide  information  on  climate  change  expenditure 
within the Health for Growth Programme. 

12 

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

EN 

13 

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

(13)  The  Programme  should  contribute  to  evidence  based  decision  making  by  fostering  a 
health  information  and  knowledge  system.  The  later  would  consist  in,  inter  alia,  collecting 
and analysing health data, supporting the scientific Committees13 and participating in the wide 
dissemination of the results of the Programme.  

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

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

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

(17)  According  to  Article  168  of  the  Treaty,  the  Union  and  the  Member  States  shall  foster 
cooperation with third countries and the competent international organisations in the sphere of 
public health. The programme should therefore be open to the participation of third countries, 
in  particular  of  acceding  countries,  candidate  countries  and  potential  candidates  benefiting 
from a pre-accession strategy, EFTA/EEA countries, neighbouring countries and the countries 
to  which  the  European  Neighbourhood  Policy  (ENP)  applies  and  other  countries  in 
accordance with the conditions laid down by a relevant bilateral or multilateral agreement. 

(18) Appropriate relations with third countries not participating in the programme should be 
facilitated  to  help  achieve  the  objectives  of  the  programme,  taking  account  of  any  relevant 

13 

14 

The  Scientific  Committees  were  set  up  in  accordance  with  Commission  Decision  2008/721/EC,  OJ 
reference 
OJ L, ,p. 

EN 

14 

   EN 

 
                                                 
agreements  between  those  countries  and  the  Union.  This  may  involve  EU  organised  health 
events  or  third  countries  taking  forward  complementary  activities  to  those  financed  through 
the  programme  on  areas  of  mutual  interest,  but  should  not  involve  a  financial  contribution 
under the Programme. 

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

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

(21) In accordance with Article 49 of Council Regulation (EC, Euratom) No 1605/2002 of 25 
June  2002  on  the  Financial  Regulation  applicable  to  the  general  budget  of  the  European 
Communities15,  this  Regulation  provides  the  legal  basis  for  the  action  and  for  the 
implementation of the Health for Growth Programme. 

(22) In order to ensure uniform conditions for the implementation of this Regulation by means 
of annual work programmes, implementing powers should be conferred on the Commission. 
Those  powers  should  be  exercised  in  accordance  with  Regulation  (EU)  No  182/2011  of  the 
European  Parliament  and  of  the  Council  of  16  February  2011  laying  down  the  rules  and 
general principles concerning mechanisms for control by Member States of the Commission's 
exercise of implementing powers16.  

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

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

(25) The cooperation of national authorities is essential in sharing information with potential 
applicants to allow equitable participation in the Programme, and knowledge produced by the 
their 
programme  with 

the  different  national  health  sector  stakeholders.  Moreover, 

15 
16 

OJ L 248, 16.9.2002, p. 1. 
OJ L 55, 28.2.2011, p 13. 

EN 

15 

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involvement in tracing the impacts generated by the Programme at national level is considered 
of major importance. Thus, National Focal Points should be designated by the Member States 
in order to support the above mentioned activities. 

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

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

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

HAVE ADOPTED THIS REGULATION: 

Chapter I 

General provisions 

Article 1 

Establishment of the Programme 

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

Article 2 

General objectives 

The  general  objectives  of  the  Health  for  Growth  Programme  shall  be  to  work  with  the 
Member States to encourage innovation in healthcare and increase the sustainability of health 
systems, to improve the health of the EU citizens and protect them from cross-border health 
threats. 

Chapter II 

Objectives and actions 

EN 

16 

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Article 3 

Specific objectives and indicators 

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

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

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

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

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

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

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

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

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

Article 4 

Eligible actions 

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

(1) Contributing to innovative and sustainable health systems: 

EN 

17 

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– 

– 

– 

– 

– 

– 

– 

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

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

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

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

1.5  Support  to  the  European  Innovation  Partnership  on  Active  and  Healthy 
Ageing, a pilot project under Europe 2020 flagship initiative Innovation Union17;  

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

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

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

– 

– 

– 

– 

– 

– 

2.1.  Set up accreditation and support European Reference Networks;  

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

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

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

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

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

(3) Promoting good health and preventing diseases: 

– 

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

17 

COM (2010) 546 final 

EN 

18 

   EN 

 
                                                 
– 

– 

– 

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

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

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

(4) Protecting citizens from cross border health threats: 

– 

– 

– 

– 

– 

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

Improve  risk  assessment  capacity  by  providing  additional  capacities  for 

4.2. 
scientific expertise and map existing assessments; 

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

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

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

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

Chapter III 

Financial provisions 

Article 5 

Funding 

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

Article 6 

Participation of third countries  

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

acceding countries, candidate countries and potential candidates benefiting from a pre-
(a) 
accession strategy, in accordance with the general principles and general terms and conditions 

EN 

19 

   EN 

 
for  their  participation  in  Union  programmes  established  in  the  respective  Framework 
Agreements, Association Council Decisions or similar Agreements; 

EFTA/EEA  countries  in  accordance  with  the  conditions  established  in  the  EEA 

(b) 
Agreement; 

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

other countries in accordance with the conditions laid down by a relevant bilateral or 

(d) 
multilateral agreement. 

Article 7 

Types of intervention 

1. In accordance with the Financial Regulation, financial contributions by the Union may take 
the  form  of  either  grants  or  public  procurement  or  any  other  interventions  necessary  for 
achieving the objectives of the Programme. 

2. Grants may be awarded to fund: 

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

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

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

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

60 % of eligible costs for an action aimed at an objective of the Programme. In cases 

(a) 
of exceptional utility, the contribution by the Union may be up to 80% of eligible costs;  

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

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

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

Article 8 

Beneficiaries eligible for grants  

1. The grants for actions referred to under Article 7 (2) (a) and (b) may be awarded to legally 
established  organisations,  public  authorities,  public  sector  bodies,  in  particular  research  and 
health institutions, universities and higher education establishments and undertakings.  

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

They are non-governmental, non-profit-making, independent of industry, commercial 

(a) 
and business or other conflicting interests; 

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

They are active at the Union level and in at least half of the Member States, and have a 

(c) 
balanced geographical coverage of the Union. 

Article 9 

Administrative and technical assistance  

The  financial  allocation  for  the  Programme  may  also  cover  expenses  pertaining  to 
preparatory,  monitoring,  control,  audit  and  evaluation  activities  required  directly  for  the 
management  of  the  Programme  and  the  achievement  of  its  objectives,  in  particular  studies, 
meetings, information and communication actions, including corporate communication of the 
political priorities of the European Union as far as they are related to the general objectives of 
this Regulation, expenses linked to IT networks focusing on information exchange, as well as 
all other technical and administrative assistance expense incurred by the Commission for the 
management of the Programme. 

Chapter IV 

Implementation 

Article 10 

Methods of implementation  

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

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Article 11 

Annual Work programmes 

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

the  priorities  and  the  actions  to  be  undertaken,  including  the  allocation  of  financial 

(a) 
resources; 

(b) 

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

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

the essential selection and award criteria to be used to select the proposals receiving 

(d) 
financial contributions; 

(e) 

the time schedule of the planned calls for the tenders and calls for proposals; 

where appropriate, the authorisation to use lump sums, standard scales of unit costs or 

(f) 
flat-rate financing in line with the Financial Regulation; 

the  actions  co-financed  by  international  organisations  active  in  the  area  of  health 

(g) 
without previous call for proposal duly justified.  

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

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

Article 12 

Consistency and complementarity with other policies 

The Commission shall, in cooperation with the Member States, ensure overall consistency and 
complementarity  between  the  Programme  and  other  policies,  instruments  and  actions  of  the 
Union. 

Article 13 

Monitoring, evaluation and dissemination of results 

1.  The  Commission  shall,  in  close  cooperation  with  the  Member  States,  monitor  the 
implementation  of  the  actions  under  the  programme  in  the  light  of  its  objectives  and 
indicators, including information on the amount of climate related expenditure. It shall report 
thereon to the committee referred to in Article 13, and shall keep the European Parliament and 
the Council informed.  

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

3. No later then mid-2018, an evaluation report shall be established by the Commission on the 
achievement  of  the  objectives  of  all  the  measures  (at  the  level  of  results  and  impacts),  the 
efficiency of the use of resources and its European added value, in view of a decision on the 
renewal,  modification  or  suspension  of  the  measures.  The  evaluation  shall  additionally 
address  the  scope  for  simplification,  its  internal  and  external  coherence,  the  continued 
relevance of all objectives, as well as the contribution of the measures to the Union priorities 
of smart, sustainable and inclusive growth. It shall take into account evaluation results on the 
long-term impact of the predecessor programme. 

The longer-term impacts and the sustainability of effects of the Health for Growth Programme 
should be evaluated with a view to feeding into a decision on a possible renewal, modification 
or suspension of a subsequent programme. 

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

Article 14 

National Focal Points 

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

Article 15 

Protection of the financial interests of the European Union 

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

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

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

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

Chapter V  

Procedural provisions 

Article 16 

Committee procedure 

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

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

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

Chapter VI  

Transitional and final provisions 

Article 17 

Transitional provisions 

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

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

Article 18 

Repeal provisions 

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

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Article 19 

Entry into force 

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

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX I  

Types of actions 

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

1.1.  Health  technology  assessment:  support  European  cooperation  on  Health  Technology 
Assessment (HTA) under the European voluntary network on Health Technology Assessment 
set  up  by  the  Directive  2011/24/EU  of  the  European  Parliament  and  of  the  Council18. 
Facilitate  the  uptake  of  the  results  streaming  from  research  projects  supported  under  7th 
Framework Programme and the in the longer term the activities which will be undertaken in 
the forthcoming research and innovation programmes 2014-2020 (Horizon 2020). 

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

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

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

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

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

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

2.  Increase  access  to  medical  expertise  and  information  for  specific  conditions  also 
beyond  national  borders  and  developing  shared  solutions  and  guidelines  to  improve 

18 

OJ L 88, 4.4.2011, p. 45. 

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healthcare  quality  and  patient  safety  in  order  to  increase  access  to  better  and  safer 
healthcare for EU citizens 

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

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

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

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

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

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

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

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

3.2.  Chronic  diseases:  support  European  cooperation  and  networking  on  preventing  and 
improving  the  response  to  chronic  diseases  including  cancer,  by  sharing  knowledge,  good 
practice  and  developing  joint  activities  on  prevention.  Cancer:  follow-up  work  already 

19 

OJ L 88, 4.4.2011, p. 45. 

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undertaken;  set  up  a  European  cancer  information  system  with  comparable  data;  support 
cancer screening, including voluntary accreditation mechanisms; support the development of 
European guidelines for prevention where major inequalities exist. 

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

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

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

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

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

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

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

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

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

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 ANNEX II  

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

1. Blood, organs, tissues and cells 

1.1. Directive 2002/98/EC of the European Parliament and the Council of 27January 2003, 
setting  standards  of  quality  and  safety  for  the  collection,  testing,  processing,  storage  and 
distribution of human blood and blood components and amending Directive 2001/83/EC (OJ 
L 33, 8.2.2003, p. 30). 

1.2. Directive 2010/45/EU of the European Parliament and the Council of 7 July 2010,  
on  standards  of  quality  and  safety  of  human  organs  intended  for  transplantation  (OJ  L  207, 
6.8.2010, p. 14). 

1.3. Directive 2004/23/EC of the European Parliament and the Council of 31 March 2004,  
on setting standards of quality and safety for the donation, procurement, testing, processing, 
preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48). 

Only  important basic legislation has been listed here; for other legislation  relating to blood, 
organs, tissues and cells please see: 
http://ec.europa.eu/health/blood_tissues_organs/key_documents/index_en.htm#anchor3 

2. Communicable diseases 

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

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

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

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

Only  important  basic  legislation  has  listed  here;  for  other  legislation  relating  to  diseases 
please see: 
http://ec.europa.eu/health/communicable_diseases/key_documents/index_en.htm#anchor1 

3. Tobacco products and advertisement 

3.1. Directive 2001/37/EC of the European Parliament and the Council of 5 June 2001, 
on  the  approximation  of  the  laws,  regulations  and  administrative  provisions  of  the  Member 
States  concerning  the  manufacture,  presentation  and  sale  of  tobacco  products  (OJ  L  194, 
18.7.2001, p. 26). 

3.2. Directive  2003/33/EC of the European Parliament and the Council of 26 May 2003, 
on  the  approximation  of  the  laws,  regulations  and  administrative  provisions  of  the  Member 
States relating to the advertising and sponsorship of tobacco products (OJ L 152, 20.6.2003, p. 
16). 

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

4. Patients’ rights in cross border health care 

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

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

5. Pharmaceutical products 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

the  establishment  of 

residue 

for 

Only  important  basic  legislation  has  been  listed  here;  for  other  legislation  relating  to 
pharmaceutical products, please see: 
Products for human use: http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm 
for 
Products 
5/index_en.htm 

http://ec.europa.eu/health/documents/eudralex/vol-

veterinary 

use: 

6. Medical devices 

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

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

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

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

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

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

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

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LEGISLATIVE FINANCIAL STATEMENT  

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1.  Title of the proposal/initiative  

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

1.3.  Nature of the proposal/initiative  

1.4.  Objective(s)  

1.5.  Grounds for the proposal/initiative  

1.6.  Duration and financial impact  

1.7.  Management method(s) envisaged  

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

2.2.  Management and control system  

2.3.  Measures to prevent fraud and irregularities  

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

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

3.2.  Estimated impact on expenditure  

3.2.1. Summary of estimated impact on expenditure  

3.2.2. Estimated impact on operational appropriations  

3.2.3. Estimated impact on appropriations of an administrative nature 

3.2.4. Compatibility with the current multiannual financial framework 

3.2.5. Third-party participation in financing  

3.3.  Estimated impact on revenue

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LEGISLATIVE FINANCIAL STATEMENT 

6. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

6.1. 

Title of the proposal/initiative 

HEALTH FOR GROWTH PROGRAMME (2014 – 2020) 

6.2. 

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

PUBLIC HEALTH  

6.3. 

Nature of the proposal/initiative  

(cid:133) The proposal/initiative relates to a new action  

(cid:133) The proposal/initiative relates to a new action following a pilot project/preparatory action20  

(cid:59)The proposal/initiative relates to the extension of an existing action  

(cid:133) The proposal/initiative relates to an action redirected towards a new action  

6.4. 

Objectives 

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

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

INNOVATION: 

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

PREVENTION: 

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

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

6.4.2. 

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

Specific objective No 1:  

20 

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

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

Specific objective No 2:  

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

Specific objective No 3:  

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

Specific objective No 4:  

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

ABM/ABB activity concerned 

PUBLIC HEALTH POLICY for all the specific objectives listed above. 

6.4.3.  Expected result(s) and impact 

Specific objective No 1:  

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

Effects at the programme's level: 

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

Effects at policy level: 

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

* Implementing innovation in health in their health systems. 
* Reaching an adequate supply of health professionals in MS. 
* Reaching a cost-effective use of medical technologies. 
*  Improving  decision-making,  organisational  management  and  performance  of  the  health 
systems. 

Beneficiaries: 

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

Specific objective No 2:  

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

Effects at the programme's level: 

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

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

Effects at policy level: 

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

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

Beneficiaries: 

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

Specific objective No 3:  

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

Effects at the programme's level: 

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

Effects at policy level: 

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

Beneficiaries: 

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

Specific objective No 4:  

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

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Effects at the programme's level: 

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

Effects at policy level: 

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

Beneficiaries: 

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

6.4.4. 

Indicators of results and impact  

Specific objective No 1 

Outcome indicators: 

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

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

Impact indicators: 

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

Specific objective No 2 

Outcome indicators: 

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

Number of guidelines developed by 2017, 2020 and 2023 

Impact indicators: 

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

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

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

Specific objective No 3 

Outcome indicators: 

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

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

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Impact indicators: 

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

Specific objective No 4 

Outcome indicators: 

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

Impact indicators: 

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

6.5. 

Grounds for the proposal/initiative  

6.5.1.  Requirement(s) to be met in the short or long term  

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

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

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

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

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

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

* increasing health inequalities in health throughout Europe 

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

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

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

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

6.5.2.  Added value of EU involvement 

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

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

6.5.3.  Lessons learned from similar experiences in the past 

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

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

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

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

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

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

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

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

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

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

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

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

Summary of the Recommendations of the Court of Auditors: 

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

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

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

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

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

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

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

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

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

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

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

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

6.5.4.  Coherence and possible synergy with other relevant instruments 

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

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

* the Structural Funds, 

* the Programme for Social Change and Innovation 

* the European Solidarity Fund,  

* the European strategy for health at work,  

* the Competitiveness and Innovation Programme, 

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

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

* the Justice programme (2014-2020),  

* the Union Statistical Programme within its respective activities,  

* the Ambient Assisted Living (AAL) Joint Programme. 

* the Education Europe Programme. 

6.6. 

Duration and financial impact  

(cid:58) Proposal/initiative of limited duration  

–  (cid:58)  Proposal/initiative in effect from 01/01/2014 to 31/12/2020 

–  (cid:58)  Financial impact from 2014 to 2023 in payment appropriations only 

(cid:133) Proposal/initiative of unlimited duration 

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

–  followed by full-scale operation. 

6.7.  Management mode(s) envisaged21  

(cid:58) Centralised direct management by the Commission  

(cid:58) Centralised indirect management with the delegation of implementation tasks to: 

–  (cid:58)  executive agencies  

–  (cid:133)  bodies set up by the Communities22  

–  (cid:133)  national public-sector bodies/bodies with public-service mission  

21 

22 

Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the  BudgWeb  site: 
http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 
As referred to in Article 185 of the Financial Regulation. 

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–  (cid:133)  persons entrusted with the implementation of specific actions pursuant to Title V of the 
Treaty  on  European  Union  and  identified  in  the  relevant  basic  act  within  the  meaning  of 
Article 49 of the Financial Regulation  

(cid:133) Shared management with the Member States  

(cid:133) Decentralised management with third countries  

(cid:58) Joint management with international organisations (to be specified) 

Comments 

Executive  Agency  for  Health  and  Consumers  (EAHC):  In  accordance  with  Council  Regulation  (EC) 
No 58/2003 of 19 December 2002 laying down the statute for Executive Agencies to be entrusted with 
certain  tasks  in  the  management  of  Community  programmes23,  the  Commission  has  entrusted24  the 
Executive  Agency  for  Health  and  Consumers  with  implementation  tasks  for  the  management  of  the 
second programme of Community Action in the field of health for 2008-2013. The Commission may 
therefore decide to entrust an executive agency also with implementation tasks for the management of 
the "Health for Growth programme 2014-2020". 

Joint management with international organisations: 

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

7. 

MANAGEMENT MEASURES  

7.1.  Monitoring and reporting rules  

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

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

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

23 
24 

OJ L 11, 16.1.2003, p. 1. 
Commission Decision C(2008)4943 of 9 September 2008. 

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

7.2.  Management and control system  

7.2.1.  Risk(s) identified  

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

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

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

The main risks are the following: 

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

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

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

7.2.2.  Control method(s) envisaged  

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

DG  SANCO  and  the  EAHC  alike  put  in  place  internal  procedures  that  aim  at  covering  the 
risks  identified  above.  The  internal  procedures  are  in  full  compliance  with  the  financial 
regulation and include cost-benefit considerations. Within this framework, SANCO continues 

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to  explore  possibilities  to  enhance  the  management  and  to  increase  simplification.  Main 
features of the control framework are the following: 

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

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

* Controls before and during the implementation of the projects: 

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

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

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

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

* Controls at the end of the project:  

EN 

44 

   EN 

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

* Costs and benefits of controls:  

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

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

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

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

7.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

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

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

EN 

45 

   EN 

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

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

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

EN 

46 

   EN 

 
8. 

8.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

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

•  Existing expenditure budget lines  

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

Heading of 
multiannual 
financial 
framework 

3: security 
and 
citizenship 

3: security 
and 
citizenship 

Budget line 

Type of  
expenditure

Contribution  

Number  

17 03 06  

EU action in the field of health 

17 01 04  

Programme  of  European  Union 
action  in  the  field  of  Health  – 
administrative 
expenditure 
management 

on 

Diff./non-
diff 
(25) 

from 
EFTA26 
countries 

from 
candidate 
countries27 

from third 
countries 

within the meaning 
of Article 18(1)(aa) 
of the Financial 
Regulation  

Diff. 

YES 

YES 

NO 

NO 

Non-diff. 

YES 

YES 

NO 

NO 

No new budget lines requested.

25 
26 
27 

Diff. = Differentiated appropriations / Non-Diff. = Non-differentiated appropriations 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 

EN 

47 

   EN 

 
 
 
                                                 
8.2. 

Estimated impact on expenditure  

8.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial 
framework:  

Number 
3 

Security and citizenship 

EUR million (to 3 decimal places) in current price

DG: SANCO 

Operational appropriations  

17 03 06 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

Subseque
nt years 

TOTAL 

Commitments 

Payments 

(1) 

(2) 

54.465 
5.000 

56.281 
16.000 

57.188 
32.000 

58.096 
49.000 

59.004 
54.000 

60.819 
57.000 

59.004 
57.000 

134.857 

404.857 
404.857 

Appropriations of an administrative nature financed from the envelope for specific programmes28  

17 01 04  

TOTAL appropriations for DG 
SANCO 

Commitments 

Payments 

(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(3) 

=1+1a 
+3 

=2+2a 
+3 

(4) 

(5) 

(6) 

TOTAL appropriations under 
HEADING 3 Security and citizenship 

Commitments 

Payments 

=4+ 6 

=5+ 6 

5.535 

5.719 

5.812 

5.904 

5.996 

6.181 

5.996 

60.000 

62.000 

63.000 

64.000 

65.000 

67.000 

65.000 

10.535 

21.719 

37.812 

54.904 

59.996 

63.181 

62.996 

134.857 

54.465 

56.281 

57.188 

58.096 

59.004 

60.819 

59.004 

5.000 

16.000 

32.000 

49.000 

54.000 

57.000 

57.000 

134.857 

5.535 

5.719 

5.812 

5.904 

5.996 

6.181 

5.996 

60.000 

62.000 

63.000 

64.000 

65.000 

67.000 

65.000 

41.143 

446.000 

446.000 

404.857 

404.857 

41.143 

446.000 

10.535 

21.719 

37.812 

54.904 

59.996 

63.181 

62.996 

134.857 

446.000 

28 

EN 

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

48 

EN

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

. 

Heading of multiannual financial 
framework:  

5 

" Administrative expenditure " 

EUR million (to 3 decimal places) in current price

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

TOTAL 

DG: SANCO 

(cid:121) Human resources SANCO (17 01 01) 

1.088 

1.110 

1.132 

1.155 

1.178 

1.202 

1.226 

8.091 

DG: SANCO 

(cid:121) Other administrative expenditure (17 01 02 11)  

2.125 

2.168 

2.211 

2.255 

2.300 

2.346 

2.300 

TOTAL DG SANCO 

Appropriations  

3.213 

3.278 

3.343 

3.410 

3.478 

3.548 

3.526 

15.705 

23.796 

TOTAL appropriations under 
HEADING 5 of the MFF  

(Total 
= Total payments) 

commitments 

3.213 

3.278 

3.343 

3.410 

3.478 

3.548 

3.526 

23.796 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework  

Commitments 

63.213 

65.278 

66.343 

67.410 

68.478 

70.548 

68.526 

Payments 

13.748 

24.997 

41.155 

58.314 

63.475 

66.729 

66.522 

469.796 

334.939 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

TOTAL 

EN 

49 

EN

 
  
 
 
 
 
 
 
 
 
8.2.2.  Estimated impact on operational appropriations  

–  (cid:133)  The proposal/initiative does not require the use of operational appropriations  

–  (cid:58)  The proposal/initiative requires the use of operational appropriations, as explained below: 

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

Indicate 
objectives and 
outputs  

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

TOTAL 

OUTPUTS 

(cid:216) 

Type 
of 
output 

Nb of 
output
s 

Cost 

SPECIFIC OBJECTIVE No 1 

SPECIFIC OBJECTIVE No 2  

SPECIFIC OBJECTIVE No 3  

SPECIFIC OBJECTIVE No 4 

3 

2 

2 

1 

26.143 

11.982 

11.438 

4.902 

Nb 
of 
out 
puts 

7 

4 

5 

3 

Cost 

Nb
of 
outp
uts 

Cost 

Nb
of 
outp
uts 

Cost 

Nb 
of 
outp
uts 

Cost 

Nb
of 
out
puts 

Cost 

Nb
of 
outp
uts 

Cost 

Total 
number 
of 
outputs 

27.015 

11 

27.450 

11 

27.886 

11 

28.322 

11 

29.193 

11 

28.322 

12.382 

11.819 

5.065 

6 

8 

5 

12.581 

12.010 

5.147 

6 

8 

5 

12.871 

12.200 

5.229 

6 

8 

5 

12.981 

12.391 

5.310 

6 

8 

5 

13.380 

12.772 

5.474 

6 

8 

5 

12.981 

12.391 

5.310 

65 

36 

47 

29 

Total  
cost 

194.331 

89.069 

85.020 

36.437 

TOTAL COST 

9 

54.174 

19 

55.980 

30 

56.882 

30 

57.785 

30 

58.688 

30 

60.494 

30 

58.688 

178 

404.857 

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

Outputs consist in:  

specific objective 1: number of tools and mechanisms developed;  

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

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

EN 

50 

E

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

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

8.2.3.  Estimated impact on appropriations of an administrative nature 

8.2.3.1.  Summary 

–  (cid:133)  The proposal/initiative does not require the use of administrative appropriations  

–  (cid:58)  The proposal/initiative requires the use of administrative appropriations, as explained below: 

EUR million in 2011 prices (to 3 decimal places) 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

HEADING 5 of MFF  

Human resources (BL 17 01 01)  

1.026 

1.026 

1.026 

1.026 

1.026 

1.026 

1.026 

7.182 

Other  administrative  expenditure  (BL  17 
01 02 11)  

2.025 

2.025 

2.025 

2.025 

2.025 

2.025 

2.025 

14.175 

Subtotal HEADING 5 of the MFF  

3.051 

3.051 

3.051 

3.051 

3.051 

3.051 

3.051 

21.357 

Outside HEADING 5 of the MFF  

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

5.320 

5.320 

5.320 

5.320 

5.320 

5.320 

5.320 

37.240 

Subtotal outside HEADING 5 of the MFF  

5.320 

5.320 

5.320 

5.320 

5.320 

5.320 

5.320 

37.240 

TOTAL  

8.371 

8.371 

8.371 

8.371 

8.371 

8.371 

8.371 

58.597 

EN 

51 

E

 
  
 
 
 
EN 

52 

E

 
  
 
8.2.3.2.  Estimated requirements of human resources  

–  (cid:133)  The proposal/initiative does not require the use of human resources  

–  (cid:58)  The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

Number of posts in FTEs 

• 

Establishment Plan Posts (officials and temporary agents) SANCO 

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

Total establishment plan posts 
SANCO 

5.7 

5.7 

5.7 

5.7 

5.7 

5.7 

5.7 

2.375 

2.375 

2.375 

2.375 

2.375 

2.375 

2.375 

8.075 

8.075 

8.075 

8.075 

8.075 

8.075 

8.075 

TOTAL 

8.075  

8.075  

8.075  

8.075  

8.075  

8.075  

8.075  

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

Description of tasks to be carried out: 

Officials and temporary agents 

In SANCO: 

Elaboration of programme, multi-annual work programme, annual work 
programmes, follow-up of implementation of the programme, evaluation, 
audits, etc. 

Coordination  with  the  executive  agency  if  an  externalisation  of  the 
management of the Programme is eventually decided. 

EN 

53 

   EN 

 
 
 
8.2.4.  Compatibility with the current multiannual financial framework  

–  (cid:58)  Proposal/initiative 

is  compatible  with 

the  2014–2020  multiannual  financial 

framework as proposed in Commission's Communication COM(2011)500. 

–  (cid:133)  Proposal/initiative  will  entail  reprogramming  of  the  relevant  heading  in  the 

multiannual financial framework. 

–  (cid:133)  Proposal/initiative requires application of the flexibility instrument or revision of the 

multiannual financial framework29. 

8.2.5.  Third-party contributions  

–  (cid:58) The proposal/initiative does not provide for co-financing by third parties  

–  (cid:133) The proposal/initiative provides for the co-financing estimated below: 

8.3. 

Estimated impact on expenditure  

–  (cid:58)  Proposal/initiative has no financial impact on revenue. 

–  (cid:133)  Proposal/initiative has the following financial impact: 

29 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

54 

   EN