Amended proposal for a Decision of the European Parliament and of the Council establishing a second Programme of Community action in the field of Health and consumer protection (2007-2013) - Adaptation following the agreement of 17 May 2006 on the Financial Framework 2007-2013 (presented by the Commission pursuant to Article 250(2) of the EC Treaty)
Date: 2006-05-24
Institutions: European Commission
Subjects: EU action, action programme, consumer information, equal treatment, health policy, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 24.5.2006 
COM(2006) 234 final 

2004/0042 A (COD) 

Amended proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

establishing a second Programme of Community action in the field of Health and consumer 
protection (2007-2013) 

Adaptation following the agreement of 17 May 2006  
on the Financial Framework 2007-2013 

(presented by the Commission pursuant to Article 250(2) of the EC Treaty) 

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EXPLANATORY MEMORANDUM 

I. Introduction  

On  6  April  2005,  the  Commission  proposed  a  wide-ranging  and  ambitious  health  and 
consumer  protection  programme  2007-20131  based  on  the  assumption  of  a  €  1,203  million 
budget  (out  of  which  €  969  million  was  for  health).  This  proposal  foresaw  a  significant 
increase  in  existing  Community  health  action  from  three  to  six  action  strands  in  order  to 
address cross-border health challenges and to meet stakeholders’ expectations.  

In  its  first  reading  Opinion  of  16  March  2006  on  the  health  part  of  the  programme,  the 
European Parliament endorsed the objectives and main actions proposed by the Commission, 
underlined  its  preference  for  a  separate  health  programme,  enlarged  further  the  scope  of 
proposed health action and requested a budget of €1,500 million.  

inter-institutional  agreement  on  the  Community  Financial 
However,  following  the 
Framework  2007-2013,  the  final  budget  for  health  action  was  settled  at  €  365.6  million,  i.e. 
approximately one third of the budget initially foreseen in the Commission proposal of April 
2005.  

Given  these  resource  constraints,  it  is  necessary  to  take  a  more  focused  approach  to 
Community  health  action.  The  Commission  therefore  proposes  to  refocus  the  scope  of  the 
programme  along  three  broad  objectives:  to  improve  citizens’  health  security;  to  promote 
health  to  improve  prosperity  and  solidarity;  and  to  generate  and  disseminate  health 
knowledge.  Priority  measures  will  be  identified  on  an  annual  basis  in  order  to  allow  the 
programme  to  focus  its  resources  on  a  few  carefully  selected  areas  adapted  to  the  political 
context and emerging needs.  

This is the purpose of the current modified proposal which replaces the original Commission 
proposal of April 2005 as far as health action is concerned. In presenting a separate proposal 
for health action only, the Commission is responding positively to the approach favoured by 
the Parliament and the Economic and Social Committee as regards splitting its proposal into 
two. A separate proposal tackles consumer protection. 

This  modified  proposal  aligns  future  health  action  more  explicitly  with  the  overall 
Community  objectives  of  prosperity,  solidarity  and  security  and  seeks  to  further  exploit 
synergies  with  other  policies,  as  highlighted  by  the  European  Parliament.  The  current 
modified  proposal  has  incorporated  to  the  extent  possible  the  Parliament’s  concerns  on  key 
strategic  issues  such  as  the  need  to  promote  healthy  ageing,  to  address  health  inequalities 
across the EU, to take gender health issues into account and to focus on cross-border issues.  

However, in the light of the budgetary constraints, this modified proposal does not include a 
specific  action  strand  to  tackle  individual  diseases  (as  in  the  Commission  original  proposal 
which was further strengthened by the European Parliament). Instead, in view of the limited 
resources,  the  Commission  aims  to  help  reduce  the  burden  of  diseases  by  tackling  the  most 
important health determinants. Nevertheless, in cases where there is important added value in 

1 

COM(2005) 115, 6.4.2005. 

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Community  level  action  on  a  specific  disease  (e.g.  on  rare  diseases  or  mental  health), 
provisions are made under the relevant objectives of the modified proposal.  

In  addition,  action  on  co-operation  between  health  systems  (a  separate  strand  in  the 
Commission  original  proposal)  has  been  considerably  streamlined  and  incorporated  into  all 
the three objectives for Community health action described further below.  

II. A healthy society as a foundation stone for prosperity, solidarity and security  

Improving health is important in its own right. But it is also an important part of the solution 
to  address  a  number  of  key  challenges  facing  Europe  such  as  population  ageing,  security 
threats  or  labour  shortages.  Improving  health  is  necessary  to  meet  the  overall  Community 
goals  which  were  set  to  respond  to  such  problems.  As  such,  health  has  a  role  to  play  in 
achieving Europe’s full potential for prosperity, solidarity and security. 

In  relation  to  prosperity,  population  health  is  a  key  factor  of  productivity  and  growth.  The 
European Parliament underlined that the promotion of health is a key element for long-term 
economic  growth  and  social  welfare2.  Better  health  policies  will  lead  to  EU  citizens  living 
longer and in better health, which is important to reduce worker absenteeism and premature 
retirement.  The  Commission  has  emphasised,  in  its  annual  reports  to  the  Spring  European 
Council, that increasing Healthy Life Years is crucial in attracting people into employment3; 
and that Europe cannot afford to have people drop out of the labour market when they are in 
their  fifties4.  Poor  health  is  a  leading  cause  of  early  retirement  and  productivity  loss. 
Increasing the number of years citizens live in good health is therefore important to fulfilling 
the Lisbon agenda. In this context and in the light of the Parliament’s first reading Opinion, 
the  current  modified  proposal  provides  a  stronger  focus  on  healthy  ageing  and  also  on 
health’s potential to promote growth. 

As  regards  solidarity,  achieving  the  Community  goal  of  a  more  cohesive  Europe,  requires 
reducing the major inequalities across the EU in terms of life expectancy, health status, and 
access to high-quality health services. This translates into major differences across the EU not 
only  in  quality  of  life,  but  also  in  productivity,  labour  participation  and  age  of  leaving  the 
labour force on invalidity grounds. Inequalities in health go hand in hand with inequalities in 
prosperity.  A  Europe  of  solidarity  cannot  neglect  these  inequalities.  In  response  to  the 
Parliament’s first reading Opinion, the modified proposal focuses more on addressing health 
inequalities, and also provides for action to improve solidarity between health systems, albeit 
streamlined in the light of budgetary constraints.  

Finally, as regards security, recent developments with avian flu and growing concerns about a 
possible  influenza  pandemic,  remind  us  of  the  urgent  need  to  step  up  efforts  to  protect  our 
citizens  against  cross-border  health  threats.  Improving  security  requires  developing 
European  and  national  capacity  to  respond  to  health  emergencies  in  a  co-ordinated  and 
efficient manner, while also respecting human rights protection and the shared values of the 
European Charter of fundamental rights. Citizens and stakeholders expect the EU to ensure a 
rapid  and  efficient  assistance  to  Member  States  in  responding  to  a  possible  pandemic  and 

2 

3 
4 

EP  Opinion  of  15.3.2006  on  the  2006  Commission  Communication  to  the  Spring  European  Council, 
25.1.2006. 
2005 Commission Communication to the Spring European Council COM(2005) 24, 2.2.2005. 
2006 Commission Communication to the Spring European Council, COM(2006) 30, 25.1.2006. 

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other  serious  health  threats.  The  EU  cannot  fail  to  act  when  the  safety  of  its  citizens  is  at 
stake. The modified proposal therefore continues to put a stress on this issue and in general 
keeps the range of action foreseen in the original proposal. Action under this programme will 
be  complementary  to  the  work  of  the  European  Centre  for  Disease  Prevention  and  Control 
(see below). 

III. Objectives of the Programme 

The programme will pursue three broad objectives in line with the Community overall goals: 

1. Improve citizens’ health security  

2. Promote health for prosperity and solidarity 

3. Generate and disseminate health knowledge  

Meeting these objectives requires close co-operation and strong synergies with other policies. 
Mainstreaming health concerns into other policies and exploiting potential for common action 
is reinforced in this modified proposal in the light of the Parliament’s first reading Opinion. 

1. Improve citizens’ health security  

1.1. Protect citizens against health threats 

The  Community  Strategic  objectives  for  2005-20095  stress  the  importance  of  countering 
threats to citizens’ health and safety at EU level (including bioterrorism). Lessons from global 
health  threats  and  recent  developments  in  avian  influenza  show  the  need  for  increased  EU 
capacity  to  address  cross-border  threats.  The  European  Centre  for  Disease  Prevention  and 
Control  (ECDC)6  ,  created  in  2004  to  analyse,  assess  and  provide  advice  on  risks  from 
communicable diseases, was a key step towards this end. 

Action under the programme will cover identification of threats beyond the ECDC remit such 
as those posed by physical and chemical agents; and support actions underpinning the further 
implementation of the Decision creating a Community surveillance network7. The programme 
will also support the development of vaccination policies and the establishment of European 
reference laboratories for rare or high-risk pathogens.  

Surveillance  simply  provides  the  information  necessary  for  the  Community  to  decide  what 
needs  to  be  done.  To  protect  citizens,  the  EU  needs  technical  and  operational  capability  to 
prepare  for  and  respond  to  health  threats  (inside  or  outside  the  EU).  The  programme  will 
therefore  support  the  development  of  EU  capacity  to  co-ordinate  a  response  at  European 
level.  It  will  contribute  to  enhancing  the  effectiveness  of  national  structures  with  action  to 
improve risk management and health emergency planning; facilitate co-ordination of actions 
in  health  emergencies;  improve  preparedness  for  health  emergencies;  and  facilitate 
networking and exchange of best practice. The programme will further help Member States 

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7 

Strategic objectives 2005-2009, « Europe 2010 », 2005. 
Regulation (EC) No 851/2004. 
Decision No 2119/98/EC. 

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to  develop  their  own  infrastructure,  capacity  and  co-ordination  arrangements  needed  to 
respond to a threat. 

1.2. Improve citizens’ safety 

Citizens  are  confronted  with  many  and  varied  threats  to  their  safety  in  addition  to  possible 
pandemics.  The  frequency  of  avoidable  incidents  and  infections  in  hospitals  raises  concerns 
about  patient  safety  across  the  EU.  The  burden  of  avoidable  illness  related  to  injuries  and 
accidents also needs to be addressed. The EU can complement national measures in this area, 
by  increasing  awareness,  fostering  knowledge  exchange  and  contributing  to  the  preparation 
of guidance material.  

In addition, the EU has a key role to play in identifying risks to health (for example related to 
exposure to chemicals contained in a product) and evaluating their possible impact. Finally, 
the  EU  has  an  important  Treaty  obligation  to  set  high  standards  of  quality  and  safety  ofr 
organs  and  substances  of  human  origin  for  medical  use.  The  programme  will  therefore 
support  the  implementation  of  Community  legislation  on  blood,  tissues  and  cells  and  help 
implement the International Health Regulations. 

This modified proposal takes account of the Parliament’s requests for the Community to treat 
serious cross-border health threats as a matter of priority, to co-ordinate closely work under 
the programme with work by the ECDC, and for action to be taken on injury prevention and 
on organs.  

2. Promote health for prosperity and solidarity 

2.1. Foster healthy, active ageing and help bridge inequalities  

Europe’s population is growing older and the proportion of working people is falling. Against 
this  background  a  key  challenge  is  to  ensure  that  the  population  ages  in  good  health.  “The 
longer people enjoy good health, the longer they can remain active and work”8 . The EU needs 
to encourage policy measures for healthy, active ageing as foreseen in the Community Lisbon 
Programme9. As highlighted to the European Council, Member States need to reduce the high 
numbers of people who are inactive because of their ill-health10. Some Member States foresee 
health measures in their Lisbon plans, not only to strengthen their labour force11, but also to 
improve  public  finances.  It  is  clear  that  an  ageing  population  in  bad  health  can  make 
healthcare  budgets  swell,  but  evidence  shows  that  improved  population  health  can  greatly 
reduce projected increases in spending. Finally, tackling an ageing society also implies a life-
cycle approach to health that ensures a sufficient focus on young people. 

This  modified  proposal  takes  account  of  the  Parliament’s  requests  for  action  to  increase 
healthy life years (a structural indicator) to meet the Lisbon goals by preventing diseases and 
promoting ageing in good health, and also its request to address children’s health. 

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11 

EP  Opinion  of  15.3.2006  on  the  2006  Commission  Communication  to  the  Spring  European  Council, 
25.1.2006. 
COM(2005) 330, 20.7.2005, Community Lisbon Programme states that the « Commission will assist the 
Member  States  in  developing  active  ageing  strategies,  including  measures  to  increase  healthy  life 
years ». 
Annex to COM(2006) 30, 25.1.2006. 
COM(2006) 30, 25.1.2006, Commission Communication to the Spring European Council. 

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Population  health  and  access  to  high  quality  health  services  varies  widely  among  Member 
States and regions. In addition, poor population health translates into lower productivity and 
labour participation. Thus a population in bad health impacts negatively on economic growth 
and the health gap feeds into the economic gap. Member States and regions whose citizens are 
in  relatively  bad  health  (compared  to  the  EU  average)  therefore  expect  the  EU  to  show 
solidarity  and  to  help  them  to  improve  their  health  capacity.  The  EU  Regional  policy  can 
support  investment  in  health  infrastructure  in  convergence  regions,  as  well  as  human 
resources  throughout  the  European  Union.  This  programme  will  also  encourage  Member 
States to invest in health in co-operation with other policies. 

As  a  response  to  the  Parliament’s  first  reading  Opinion,  this  programme  will  take  forward 
action to identify the causes of health inequalities within and between Member States with a 
particular emphasis on the situation in the new Member States; and will encourage exchange 
of  best  practice  to  address  such  inequalities.  This  modified  proposal  therefore  takes  full 
account of the  Parliament’s requests for action on health inequalities to  be a  priority of the 
programme and will seek to contribute to bridging the health gap across the EU. 

In  addition,  the  modified  proposal  takes  account  of  the  Parliament’s  request  for  the 
programme to focus on cross-border issues. Synergies and complementarities would be sought 
with the health related cross border projects under the regional policy territorial cooperation 
objective.  The  programme  will  foster  co-operation  between  health  systems  on  a  number  of 
growing cross-border issues such as the mobility of patients and health professionals. 

2.2. Promote healthier ways of life by tackling health determinants 

Key  influences  on  population  health  are  health  determinants  such  as  nutrition,  alcohol, 
tobacco  and  drug  consumption  as  well  as  the  quality  of  social  and  physical  environments. 
Action  in  these  areas  is  essential  in  order  to  improve  health  and  wellbeing  and  prevent 
premature  death  and  disability.  In  particular  the  growing  burden  of  avoidable  diseases 
related to life-style and addiction in all EU Member States calls for Community level action to 
facilitate co-operation, exchange good practice and complement national measures.  

Promoting  good  health  therefore  requires  tackling  the  life-style  factors  (e.g.  nutrition, 
physical  activity  and  sexual  health),  and  addictions  (e.g.  tobacco,  alcohol,  drugs)  that 
undermine health, as well as broader socio-economic and environmental health determinants.  

This  proposal  takes  into  account  the  Parliament’s  support  for  Community  action  on  health 
promotion  and  prevention.  It  foresees  focused  action  in  particular  on  lifestyle  determinants 
and addiction-related determinants. 

In  the  light  of  budgetary  constraints,  the  separate  “disease”  strand  included  in  the 
Commission’s  original  proposal  is  no  longer  viable.  However,  tackling  the  most  important 
health determinants will have the effect of contributing  to  reducing  the  disease  burden.  For 
example, action to support healthy diets can contribute to reducing heart disease, and action 
on sexual health can contribute to fighting HIV/AIDS. 

3. Generate and disseminate health knowledge  

3.1. Exchange knowledge and best practice  

There is much scope for exchange of knowledge and best practice on a range of health issues. 
The Parliament has put a particular emphasis on the need for Community action to provide 

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added value  and focus on cross-border  issues. In  this context,  exchange  of best practice will 
target  issues  where  the  Community  can  provide  genuine  added-value  in  bringing  together 
expertise  from  different  countries,  as  is  the  case  with  rare  diseases,  or  cross-border  issues 
related  with  co-operation  between  health  systems.  It  will  also  include  horizontal  issues 
stressed in the Parliament’s first reading Opinion, such as gender-related aspects of health or 
children’s health. Finally, other key issues of common interest to all Member States such as 
mental health will also be covered. Exchange of knowledge and best practice will complement 
national measures and enable Member States to benefit from solutions developed elsewhere in 
the EU. Such exchange of knowledge may need to be preceded by collection of information. 

This  modified  proposal  therefore  takes  into  account  the  Parliament’s  request  for  action  in 
particular on gender aspects of health, and also on children’s health (not specifically foreseen 
in  annex  2  of  the  Commission  original  proposal).  It  also  addresses  the  Parliament’s  request 
for  the  Community  to  focus  on  added  value  cross-border  health  issues  such  as  patient 
mobility.  

3.2. Collect, analyse and disseminate health information 

Developing  a  sound  health  knowledge  base  is  essential  to  develop  an  evidence-base  health 
policy.  In  addition,  stakeholders  and  policy-makers  rely  on  the  EU  to  provide  them  with 
comparable, reliable and up to date health information. To generate and disseminate health 
knowledge  means  expanding  existing  work  to  develop  an  EU  health  monitoring  system  that 
feeds into all health activities, using the Community Statistical Programme as necessary.  

As supported in the Parliament’s first reading Opinion, the programme will continue efforts 
to develop indicators and other tools, and to collect data and information as a basis for policy-
making. In addition, as envisaged in the original Commission  proposal,  the  programme will 
increasingly focus on providing analysis and disseminating information to citizens in a user-
friendly manner, such as the Health portal. A stronger focus on communication with citizens 
will also underpin efforts to bring Europe – and European health policy – closer to its citizens.  

IV. 

Implementation of the Programme 

This modified proposal keeps the instruments and main implementing provisions of the initial 
Commission  proposal  of  April  2005  and  takes  on  board  a  number  of  European  Parliament 
amendments which add detail and transparency to the initial proposal. 

In  line  with  better  regulation  principles,  particular  efforts  will  be  made  to  ensure  policy 
coherence between this instrument and other Community programmes. As requested by the 
Parliament in its first reading Opinion, the programme will strengthen synergies with other 
Community  policies  and  programmes  such  as  regional  development  and  the  Structural 
Funds, the Community statistical programme, the Community strategy for health and safety 
at work, the Sustainable development strategy, the Framework research programmes and the 
Lisbon agenda; and will seek to pursue, where appropriate, joint actions with other policies.  

Civil society participation in health policy-making will be promoted. Major initiatives under 
this programme will take full account of consultation with stakeholders. Health policies will 
be shaped in partnership with citizens and stakeholders e.g. by providing support to develop 
organisations representing patients’ interests or which take forward the health agenda. 

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As requested by the European Parliament, a stronger focus is put on reporting regularly the 
key results of the programme to the other Institutions, and also on the careful evaluation of 
the  impact  of  future  initiatives.  In  addition,  the  Commission  has  taken  on  board  the 
Parliament’s request for the draft Decision to provide clear criteria for NGOs eligible for core 
grants. This contributes to providing more transparency in the text, in accordance with better 
regulation principles. However, in the light of  budgetary  constraints,  this modified proposal 
brings  down  the  maximum  core  funding  in  exceptional  cases  from  95%  (as  in  the  original 
Commission proposal and endorsed by the Parliament) to 80%. 

The  existing  executive  agency,  set  up  for  the  Public  Health  Programme,  should  assist  in  the 
implementation  of  the  proposed  new  health  programme.  To  increase  cost-efficiency  and 
exploit  economies  of  scale,  the  same  agency  should  also  assist  in  the  implementation  of  the 
consumer programme as well as in the implementation of food safety training measures. The 
Commission  therefore  envisages  to  modify  accordingly  its  Decision  of  15  December  2004 
setting up the executive agency. 

The  existing  Public  Health  Programme  puts  a  strong  focus  on  co-financing  cross-border 
action  through  project  grants.  The  Commission  proposes  that  the  future  programme  will 
reduce the proportion of co-financing of projects and focus more on calls for tender in order 
to  maximise  the  efficiency,  effectiveness  and  added-value  of  actions  financed  under  the 
programme, and as a means to ensure that resources are clearly channelled to needs related to 
the programme objectives. 

Finally, this programme is being developed as part of a broad-ranging health strategy, which 
will be presented by the Commission in 2007. The programme covers essentially those actions 
that  require  financial  resources.  The  future  strategy  will  bring  together  under  a 
comprehensive framework the broad range of Community heath action and define goals and 
priorities.  Key  issues,  such  as  the  mainstreaming  of  health  concerns  in  other  policies, 
addressing  health  inequalities,  and  responding  to  international  issues  will  be  developed 
further in the strategy.  

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2004/0042 A (COD) 

Amended proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

establishing a second12 Programme of Community action in the field of Health and consumer 
protection (2007-2013) 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Articles 152 
and 153 thereof13, 

Having regard to the proposal from the Commission14, 

Having regard to the opinion of the European Economic and Social Committee15, 

Having regard to the opinion of the Committee of the Regions16, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty17, 

Whereas: 

(1) 

The Community can contribute to protecting the health and safety and economic interests of 
citizens  through  actions  in  the  fields  of  public  health  and  consumer  protection18.  A  high 
level of health protection should be ensured in the definition and implementation of all 
Community policies and activities. Under Article 152 of the Treaty, the Community is 
required to play an active role by taking measures which cannot be taken by individual 
Member States, in accordance with the principle of subsidiary. The Community fully 
respects the prerogatives of Member States in the organisation and delivery of health 
services and medical care 19. 

(2) 

The  health  sector  is  characterised  on  the  one  hand  by  its  considerable  potential  for 
growth, innovation and dynamism and on the other by the challenges it faces in terms 

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15 
16 
17 
18 
19 

EP am. 1, COM had rejected it initially on grounds of split. 
EP am. 2, COM had rejected it initially on grounds of split. 
OJ C 172[…], …of 12.7.2005, p. 25[…]. 
EESC/2006/230 of 14.2.2006 - OJ C , , p. . 
Opinion COR/2005/147 of 16.2.2006 - OJ C , , p. . 
OJ C , , p. . 
Part of EP am. 3 which COM had rejected initially on grounds of split. 
EP am. 4. 

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(3) 

(4) 

(5) 

of  financial  and  social  sustainability  and  efficiency  of  the  health  care  systems  due, 
among other things, to the ageing population and to medical advances20. 

The programme of Community action in the field of public health (2003-2008) was the 
first  integrated  European  Community  programme  in  this  field,  and  has  already 
delivered a number of important developments and improvements21. 

A number of serious cross-border health threats with a possible world-wide dimension 
exist  and  new  ones  are  emerging  which  require  further  Community  action.  The 
Community  should  treat  serious  cross-border  health  threats  as  a  matter  of  priority. 
Monitoring,  early  warning  and  action  to  combat  serious  threats  to  health  require  a 
capacity of the Community to respond in an effective and coordinated fashion22. 

According to the WHO European Health report 2005, in terms of Disability Adjusted 
Life-Years (DALYs) the most important causes of the burden of disease in the WHO 
European Region are non-communicable diseases (NCDs – 77% of the total), external 
causes of injury and poisoning (14%) and communicable diseases (9%). Seven leading 
conditions  –  ischaemic  heart  disease,  unipolar  depressive  disorders,  cerebrovascular 
disease, alcohol use disorders, chronic pulmonary disease, lung cancer and road traffic 
injuries  –  account  for  34%  of  the  DALYs  in  the  Region.  Seven  leading  risk  factors- 
tobacco,  alcohol,  high  blood  pressure,  high  cholesterol,  overweight,  low  fruit  and 
vegetable  intake  and  physical  inactivity  –  account  for  60%  of  DALYs.  In  addition, 
communicable  diseases,  such  as  HIV/AIDS,  influenza,  tuberculosis  and  malaria  are 
also becoming a threat to the health of all people in Europe. An important task of the 
programme, 
in  cooperation  when  necessary  with  the  Community  Statistical 
Programme, would be to identify better the main health burdens in the Community23. 

(6) 

Eight  leading  causes  of  mortality  and  morbidity  from  NCDs  in  the  WHO  European 
Region  are  cardiovascular  disease,  neuropsychiatric  disorders,  cancer,  digestive 
diseases,  respiratory  diseases,  sense  organ  disorders,  musculoskeletal  diseases  and 
diabetes mellitus24. 

(7)  Microbial resistance to antibiotics and nosocomial infections are becoming a threat to 
health in Europe. Lack of new effective antibiotics as well as how to ensure the proper 
use of existing antibiotics are major concerns. Therefore it is important to collect and 
analyse relevant data25. 

(8) 

Strengthening the role of the European Centre for Disease Prevention and Control is 
important in the fight against communicable diseases26. 

20 

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22 
23 
24 

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26 

EP am. 6, accepted by COM. Additional editorial change (“Rise in life expectancy” replaced by “ageing 
population”). 
EP am. 7. 
EP am. 8. 
EP am. 9. 
From EP am. 10, accepted by COM with modifications. This leaves out detailed wording on diabetes and 
replaces “deaths” by “mortality and morbidity”. This modified proposal also leaves out ams 11 and 12 
on  diabetes  and  cancer,  initially accepted  by COM. In  the  light  of budgetary  constraints the modified 
proposal abandons the disease strand of the original proposal and these ams are no longer appropriate. 
EP am. 13. 
EP am. 14 accepted by COM with modifications (as in GRI fiche). 

EN 

10 

  EN 

 
                                                 
(9) 

The  Programme  builds  on  the  achievements  of  the  previous  programme  for 
Community action in the field of public health (2003-2008). It will contribute towards 
the  attainment  of  a  high  level  of  physical  and  mental  health  and  greater  equality  in 
health  matters  throughout  the  Community,  by  directing  actions  towards  improving 
public  health,  preventing  human  diseases  and  disorders,  and  obviating  sources  of 
danger to health with a view to combating morbidity and premature mortality27. 

(10)  The  programme  should  place  emphasis  on  improving  the  health  condition  and 
promoting  a  healthy  lifestyle  and  a  culture  of  prevention  among  children  and  young 
people28. 

Whilst  maintaining  the  core  elements  and  specificities  of  actions  on  health  and  consumer 
protection, a single integrated programme should help to maximise synergies in objectives 
and efficiency in administration of actions in these areas. Combining health and consumer 
protection activities in a single programme should help to meet joint objectives on protecting 
citizens from risks and threats, increasing the ability for citizens to have the knowledge and 
opportunity to make decisions in their interests and supporting mainstreaming of health and 
consumer  objectives  in  all  Community  policies  and  activities.  Combining  administrative 
structures and systems should enable more efficient implementation of the programme and 
help to make best use of available Community resources for health and consumer protection. 

(11)  The  Programme  should  support  the  mainstreaming  of  health  objectives  in  all 
Community  policies  and  activities,  without  duplicating  work  carried  out  under  other 
Community policies29.  Coordination with  other Community  policies and programmes 
is  a  key  part  of  the  objective  of  mainstreaming  health  in  other  policies.  In  order  to 
promote synergies and avoid duplication, joint actions may be undertaken with related 
Community  programmes  and  actions  and  appropriate  use  will  be  made  of  other 
Community  funds  and  programmes  including  the  current  and  future  Community 
framework  programmes  for  research  and  their  outcomes,  the  Structural  Funds,  the 
European  Solidarity  Fund,  the  European  strategy  for  health  at  work  and  the 
Community Statistical Programme30. 

(12)  Special  efforts  will  be  undertaken  to  ensure  coherence  and  synergies  between  this 
Community health programme and the Community’s external actions, particularly in 
the  areas  of  avian  influenza,  HIV/AIDS,  tuberculosis  and  other  trans-national  health 
threats.  In  addition,  there  should  be  international  cooperation  in  order  to  promote 
general  health  reform  and  general  health  institutional  issues  in  countries  outside  the 
European Union. 

(13) 

Increasing  Healthy  Life  Years  (HLY),  also  called  disability-free  life  expectancy 
indicator,  by  preventing  disease  and  promoting  ageing  with  good  health  is  important 
for the well-being of EU citizens and helps to meet the challenges of the Lisbon process 

27 
28 
29 
30 

From EP am. 16, partially accepted by COM. Leaves out EP wording on ethnic origin (as in GRI fiche). 
EP am. 17, “will place emphasis” was replaced by “should place emphasis”. 
EP (am. 19, which COM had rejected initially on grounds of split. 
From EP am. 38 which COM had rejected initially on grounds of split. The modified proposal has some 
changes:  “will  be  undertaken”  was  replaced  by  “may  be  undertaken”  to  align  this  recital  with  the 
wording of article 6; some examples of funds and the last sentence of am. 38 were left out. 

EN 

11 

  EN 

 
 
                                                 
as  regards  the  knowledge  society  and  the  sustainability  of  public  finances  which  are 
under pressure from rising health care and social security costs31. 

(14)  The enlargement of the European Union has brought additional concerns in terms of 
health  inequalities  within  the  EU  and  this  is  likely  to  be  accentuated  by  further 
enlargements. This issue should, therefore, be one of the priorities of the Programme32. 

(15)  The  Programme  should  help  to  identify  the  causes  of  health  inequalities  and 
encourage, among other things, the exchange of best practice to tackle them33. 

(16) 

It  is  essential  to  systematically  collect,  process  and  analyse  comparable  data  for  an 
effective  monitoring  of  the  state  of  health  in  the  European  Union.  This  would  enable 
the  Commission  and  the  Member  States  to  improve  information  to  the  public  and 
formulate appropriate strategies, policies and actions to achieve a high level of human 
health protection. Compatibility and interoperability of the systems and networks for 
exchanging  information  and  data  for  the  development  of  public  health  should  be 
pursued  in  the  actions  and  support  measures.  Gender,  and  age  are  important  health 
considerations. Therefore, relevant data should take this into account34. The collection 
of  data  must  be  in  compliance  with  the  relevant  legal  provisions on  the  protection  of 
personal data35. 

(17)  Best  practice  is  important  because  health  promotion  and  prevention  should  be 
measured  on  the  basis  of  efficiency  and  effectiveness  and  not  purely  in  economic 
terms36.  It  is  important  to  promote  best  practice  and  latest  treatment  methods  for 
diseases and injuries in order to prevent further deterioration of health, and to develop 
centres of reference for specific conditions. It is also important to promote a range of 
options that can be selected from37. 

(18)  Action should be taken in order to prevent injuries by collecting data, analysing injury 

determinants and disseminating relevant information38. 

(19)  The  Programme  should  contribute  to  the  collection  of  data  and  the  promotion  of 
relevant policies on patient mobility as well as on the mobility of health professionals. 
It  should  facilitate  the  further  development  of  the  European  e-Health  Area,  through 
joint European initiatives with other EU policy areas, including regional policy, while 
contributing towards work on quality criteria for health-related websites and towards 
a European health insurance card39. 

31 
32 
33 
34 
35 
36 
37 
38 
39 

EP am. 20. 
EP am. 21. 
EP am. 22. 
EP am. 23 accepted by COM with modifications (as in GRI fiche). EP wording on ethnic origin left out. 
EP am. 24. 
(EP am. 25 accepted by COM with additional editorial changes (shortening). 
EP am. 26 accepted by COM with modifications (as in GRI fiche). 
EP am. 27 accepted by COM with modifications (as in GRI fiche). 
EP am. 28 accepted by COM with modifications (as in GRI fiche) mainly to clarify this programme is 
not responsible for websites criteria. 

EN 

12 

  EN 

 
                                                 
(20)  The promotion of telemedicine applications may contribute to patient mobility and to 
medical  care  at  home,  thereby  helping  to  reduce  the  burden  caused  by  disease  and 
injury40. 

(21)  Environmental pollution is a serious risk to heath and a major source of concern for 
European citizens. Special action should focus on children and other groups which are 
particularly  vulnerable  to  hazardous  environmental  conditions.  The  Programme 
should  complement  the  actions  taken  within  the  Environmental  and  Health  Action 
Plan 2004-201041. 

(22)  The Programme should address gender-related and ageing-related health issues42. 

(23)  The precautionary principle and risk assessment are key factors for the protection of 
human  health  and  should  therefore  be  part  of  further  integration  into  other 
Community policies and activities43. 

(24) 

In order to ensure a high level of coordination between actions and initiatives taken by 
the  Community  and  Member  States  in  the  implementation  of  the  Programme,  it  is 
necessary  to  promote  cooperation  between  Member  States  and  to  enhance  the 
effectiveness of existing and future networks in the field of public health44. 

(25)  The participation of national, regional and local authorities at the appropriate level in 
accordance  with  the  national  systems  should  be  taken  into  account  in  regard  to  the 
implementation of the Programme45. 

Health  and  consumer  protection  policies  share  common  objectives  relating  to  protection 
against  risks,  improving  decision-making  of  citizens  and  integrating  health  and  consumer 
protection  interests  in  all  Community  policies,  as  well  as  common  instruments  such  as 
communication, capacity-building for civil society regarding health and consumer protection 
issues,  and  promoting  international  cooperation  on  these  issues.  Issues  such  as  diet  and 
obesity,  tobacco  and  other  consumption-related  choices  related  to  health  are  examples  of 
cross-cutting issues affecting both health and consumer protection. Taking a joint approach 
to  these  common  objectives  and  instruments  will  enable  activities  common  to  both  health 
and  consumer  protection  to  be  undertaken  more  efficiently  and  effectively.  There  are  also 
separate objectives relating to each of the two areas of health and consumer protection which 
should be addressed through actions and instruments specific to each of the two areas. 

(26) 

It is necessary to increase EU investment in health and health-related projects. In this 
regard, Member States are encouraged to identify health improvements as a priority in 
their national programmes. Better awareness about the possibilities of EU funding for 

40 
41 
42 
43 
44 
45 

EP am. 29 accepted by COM with modifications (as in GRI fiche). 
EP am. 30. 
This seeks to represent the spirit of EP detailed ams 31 and 32, which COM accepted partially. 
EP am. 34. 
EP am. 35. 
EP am. 36. 

EN 

13 

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health  is  needed.  Exchange  of  experience  between  the  Member  States  on  funding 
health through the Structural Funds should be encouraged46. 

(27)  Non-governmental organisations and specialised networks also play an important role 
in  promoting  public  health  and  representing  citizens'  interests  in  health  policy  in  the 
Community.  They  It  is  of  general  European  interest  that  the  health,  safety  and  economic 
interests  of  citizens,  as  well  as  consumer  interests  in  the  development  of  standards  for 
products and services, be represented at Community level. Key objectives of the programme 
may  also  depend  on  the  existence  of  specialised  networks  that  also  require  Community 
contributions  to  enable  them  to  develop  and  function.  Eligibility  criteria  and  provisions 
regarding  financial  transparency  for  non-governmental  organisations  and  specialised 
networks qualifying for Community support should be established under this Decision. 
Given the particular nature of the organisations concerned and in cases of exceptional utility, 
the  renewal  of  Community  support  to  the  functioning  of  such  organisations  may  be 
exempted from should not be subject to the principle of gradual decrease of the extent of 
Community support47. 

(28) 

Implementation  of  the  Pprogramme  should  include  build  upon  and  extend  existing actions 
and structural arrangements in the fields of public health and consumer protection, including 
the  Executive  Agency  for  the  Public  Health  Programme  set  up  by  Commission  Decision 
2004/858/EC Implementation of the Programme should be carried out in close cooperation 
with relevant organisations and agencies, in particular with the European Centre for Disease 
Prevention  and  Control48  established  by  Regulation  (EC)  No  851/2004  of  the  European 
Parliament and of the Council49. 

(29)  The  measures  necessary  for  the  implementation  of  this  Decision  should  be  adopted  in 
accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures  for  the  exercise  of  implementing  powers  conferred  on  the  Commission50, 
respecting the  need for  transparency as well as a reasonable balance between the different 
objectives of the Pprogramme. 

(30)  The  Agreement  on  the  European  Economic  Area  (hereinafter  referred  to  as  the  EEA 
Agreement)  provides  for  cooperation  in  the  fields  of  health  and  consumer  protection 
between  the  European  Community  and  its  Member  States,  on  the  one  hand,  and  the 
countries  of  the  European  Free  Trade  Association  participating  in  the  European  Economic 
Area  (hereinafter  referred  to  as  the  EFTA/EEA  countries),  on  the  other.  Provision  should 
also be made to open the Pprogramme to participation by other countries, in particular the 
neighbouring countries of the Community, countries that are applying for, candidates for or 

46 

47 

48 
49 

50 

EP  am. 39,  accepted  by COM  with  modifications. Member  States “are  encouraged  to  identify”  rather 
than Member States “should identify”. 
EP am. 40 initially rejected by COM on grounds of the split (exclusion of consumer NGOs). In addition, 
COM  changed  the  text  in  the  last  sentence  from  “should  not  be  subject  to  the  principle  of  gradual 
decrease”  to  “may  be  exempted  from  the  principle  of  gradual  decrease”  to  align  this  recital  with  the 
wording used in article 4.3. 
OJ L 142, 30.4.2004, p. 1. 
Part of EP am. 41 initially rejected by COM on grounds of split. The text of the modified proposal leaves 
out the last sentence of am. 41. 
OJ L 184, 17.7.1999, p. 23. 

EN 

14 

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acceding  to  membership  of  the  Community,  taking  particular  account  of  the  potential  for 
threats to health arising in other countries to have an impact within the Community51. 

(31)  Appropriate  relations  with  third  countries  not  participating  in  the  Pprogramme  should  be 
facilitated in order to help achieve the objectives of the Pprogramme, taking account of any 
relevant  agreements  between  those  countries  and  the  Community.  This  may  involve  third 
countries  taking  forward  complementary  activities  to  those  financed  through  theis 
Pprogramme on areas of mutual interest, but will not involve a financial contribution under 
the is Pprogramme. 

(32) 

It is appropriate to develop cooperation with relevant international organisations such as the 
United  Nations  and  its  specialised  agencies  including  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  pProgramme  through  maximising  the 
effectiveness  and  efficiency  of  actions  relating  to  health  and  consumer  protection  at 
Community and international level, taking account of the particular capacities and roles of 
the different organisations.  

(33)  Progress  towards  meeting  the  health  objectives  under  this  Programme  needs  to  be 
measured  and  evaluated  Iin  order  to  increase  the  value  and  impact  of  the  programme 
Programme.  tThere  should  be  regular  monitoring  and  evaluation,  including  independent 
external evaluations, of the measures taken52. 

(34)  Since the objectives of the action to be taken on health and consumer protection cannot be 
sufficiently  achieved  by  the  Member  States  due  to  the  trans-national  nature  of  the  issues 
involved,  and  can  therefore  by  reason  of  the  potential  for  Community  action  to  be  more 
efficient  and  effective  than  national  action  alone  in  protecting  the  health  and,  safety  and 
economic interests of citizens, be better achieved at Community level, the Community may 
adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the 
Treaty.  In  accordance  with  the  principle  of  proportionality,  as  set  out  in  that  Article,  this 
dDecision does not go beyond what is necessary in order to achieve those objectives. 

(35) 

In accordance with Article 2 of the Treaty, which provides that equality between men 
and women is a principle of the European Community, and in accordance with Article 
3(2)  thereof,  which  provides  that  the  Community  shall  aim  to  eliminate  inequalities, 
and  to  promote  equality,  between  men  and  women  in  all  Community  activities 
including the attainment of a high level of health protection, all objectives and actions 
covered  by  the  Programme  of  Community  action  in  the  field  of  health  contribute  to 
promoting  a  better  understanding  and  recognition  of  men’s  and  women’s  respective 
needs and approaches to health53. 

(36)  The  Commission  should  ensure  an  It  is  appropriate  to  ensure  a  transition  between  theis 
Pprogramme  and  the  previoustwo  programmes  it  replaces,  in  particular  regarding  the 
continuation  of  multi-annual  arrangements  measures  for  its  management,  such  as  the 
financing  of  technical  and  administrative  assistance54.  As  of  1  January  2014,  the 

51 
52 
53 
54 

EP am. 42 initially rejected by COM on grounds of split. 
EP am. 44. 
EP am. 46, accepted with modifications by COM (as in GRI fiche). 
Part of EP am. 47 initially rejected by COM on grounds of split. 

EN 

15 

  EN 

 
                                                 
technical  and  administrative  assistance  will  ensure,  if  necessary,  the  management  of 
actions not yet finalised by the end of 2013and administrative support structures such as 
the Executive Agency for the Public Health Programme. 

(37)  Continued effort is required in order to meet the objectives already established by the 
Community  in  the  field  of  public  health.  It  is  therefore  appropriate  to  establish  a 
second  Programme  of  Community  action  on  health  (2007-2013),  hereinafter  "the 
Programme",  as  set  out  in  this  Decision,  replacing  Decision  No  1786/2002/EC  of  the 
European Parliament and of the Council of 23 September 2002 adopting a Programme 
of Community action in the field of public health (2003-2008)55.  This Decision should 
therefore be repealed56. 

HAVE DECIDED AS FOLLOWSADOPTED THIS DECISION: 

Article 1 

Establishment of the Programme 

The second A programme of “Community action in the field of health (2007-2013)”and consumer 
protection covering the period from the day of entry into force of this Decision 1 January 2007 to 
31 December 2013, hereinafter referred to as ‘the Pprogramme’ is hereby established57. 

Article 2 

Aim and objectives 

The  programme  shall  complement,  and  support  and  add  value  to  the  policies  of  the 
Member  States  and  shall  contribute  to  protecting  and  promoting  human  tecting  the 
health and, safety and improving public healthand economic interests of citizens58.  

The objectives to be pursued through the actions set out in the Annex to this Decision 
shall be59:  

- 

- 

- 

- 

The  aim  referred  to  in  paragraph  1  shall  be  pursued  through  common  objectives 
together with specific objectives in the fields of health and consumer protection. 

Improve citizens’ health security  

Promote health to improve prosperity and solidarity 

Generate and disseminate health knowledge60 

OJ L 271, 9.10.2002, p. 1. Decision as amended by Decision No 786/2004/EC (OJ L 138, 30.4.2004, p. 7). 
From EP am. 15, which COM had rejected initially on grounds of split. 
EP(From am. 48 initially rejected by COM initially on grounds of split). 
Part of am. 49 initially rejected by COM on grounds of split (From am. 49). 
Part of EP am. 49. 
These  objectives  respond to the need to streamline  the  programme  in  the  light of  the  reduced  budget. 
COM  has  also  incorporated  the  spirit  of  EP  am.  50  in  the  sub-objectives  detailed  in  the  explanatory 

1. 

2. 

55 
56 
57 
58 
59 
60 

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16 

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(a)  The  common  objectives  for  health  and  consumer  protection  to  be  pursued  through 

the actions and instruments set out in Annex 1 to this Decision shall be: 

– 

– 

– 

– 

– 

– 

– 

– 

to  protect  citizens  from  risks  and  threats  that  are  beyond  the  control  of 
individuals; 

to increase the ability of citizens to take better decisions about their health and 
consumer interests; 

and to mainstream health and consumer policy objectives. 

(b) 
instruments set out in Annex 2 to this Decision shall be: 

The specific health objectives to be pursued through the actions and 

to protect citizens against health threats; 

to promote policies that lead to a healthier way of life; 

to contribute to reducing the incidence of major diseases; 

and to improve efficiency and effectiveness in health systems. 

(c)  The  specific  consumer  protection  objectives  to  be  pursued  through  the  actions  and 

instruments set out in Annex 3 to this Decision shall be: 

– 

– 

– 

– 

a better understanding of consumers and markets; 

better consumer protection regulation; 

better enforcement, monitoring and redress; 

and better informed and educated and responsible consumers. 

Article 3 

Methods of implementation 

Actions in pursuit of the aims and objectives set out in Article 2 shall make full use of appropriate 
available methods of implementation, including in particular: 

(a) 

(b) 

direct or indirect implementation by the Commission on a centralised basis; 

and joint management with international organisations, where appropriate. 

memorandum  and  in  the  annex  (accepted  by  COM  with  modifications)  which  creates  additional 
objectives on health protection, health inequalities and co-operation between Member States. 

EN 

17 

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Article 4 

Financial contributions 

1. 

For the purpose of paragraph 1(a) above,fFinancial contributions by the Community shall 
not exceed the following levels: 

(a) 

60%  of  costs  for  an  action  intended  to  help  achieve  an  objective  forming  part  of  a 
Community  policy  within  the  field  of  health  and  consumer  protectionthis 
Programme,  except  in  cases  of  exceptional  utility  where  the  Community 
contribution shall not exceed 80%; and61, 

(b)  60% of costs of expenditure for the functioning of a body or a specialised network, 
which  is  non-governmental,  non-profit-making  and  independent  of  industry, 
commercial and business or other conflicting interests, has members in at least 
half  of  the  Member  States  and  has  as  its  primary  objective  the  promotion  of 
health or the prevention or treatment of diseases in the European Community, 
pursuing  an  aim  of  general  European  interest  where  such  support  is  necessary  to 
ensure  representation  of  health  or  consumer  interests  at  Community  level  or  to 
implement key objectives of the Pprogramme. except Iin cases of exceptional utility, 
where the Community contribution shall not exceed 80%. 95%.  

For  the  purpose  of  paragraph  1  above,  criteria  for  assessing  whether  or  not 
exceptional  utility  applies  shall  be  established  in  advance  in  the  annual  work  plan 
referred to in Article 10(1)(a) and shall be published. 

The  renewal  of  such  financial  contributions  set  out  in  paragraph  1(b)  to  non-
governmental  organisations  and  specialised  networks  may  be  exempted  from  the 
principle of gradual decrease62. 

For the purpose of paragraph 1(a) above, fFinancial contributions by the Community may, 
where appropriate given the nature of the objective to be achieved, include joint financing 
by  the  Community  and  one  or  more  Member  States  or  by  the  Community  and  the 
competent  authorities  of  other  participating  countries.  In  this  case,  the  Community 
contribution  shall  not  exceed  50%,  except  in  cases  of  exceptional  utility,  where  the 
Community  contribution  shall  not  exceed  70%.  These  Community  contributions  may  be 
awarded to a public body or a non-profit-making body designated through a transparent 
procedure by the Member State or the competent authority concerned and agreed by the 
Commission. 

For the purpose of paragraph 1(a) above, fFinancial contributions by the Community may 
also  be  given  in  the  form  of  flat-rate  or  lump  sum  financing  where  this  is  suited  to  the 
nature  of  the  actions  concerned.  For  such  financial  contributions  the  percentage  limits 

EP (am. 52 initially rejected by COM on the grounds of the split). 
Part of EP (From am. 53 initially rejected by COM in GRI on grounds of split. This modified proposal 
incorporates most of the wording of am. 53. It does not incorporate, however, the 75% ceiling requested 
by the EP in am. 53 nor the wording on obligation of two-year framework partnership conventions. In 
addition, it changes the exceptional utility contribution from 95 to 80%.). 

2. 

3. 

4. 

5. 

61 
62 

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18 

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stipulated in paragraphs 1, 2, and 3 and 4 above shall not apply, although a co-financing 
is still required. The criteria for selecting, monitoring and evaluating such actions shall be 
adapted as necessary. 

Article 54 

Implementation of the Programme 

1. 

The Commission shall ensure the implementation, in close cooperation with the Member 
States, of the actions  and measures set  out in the pProgramme  in  accordance  with  the 
provisions  of  Articles  76  and  106387  and  ensuring  its  harmonious  and  balanced 
development. 

2.1a 

As  part  of  the  implementation  of  the  Programme,  the  Commission  shall  ensure  the 
coordination of networks for health monitoring and rapid reaction to health threats64. 

3.1b.  The  Commission  and  the  Member  States  shall  take  appropriate  action,  within  their 
respective areas of competence, to ensure the efficient running of the Programme and 
to  develop  mechanisms  at  Community  and  Member  State  level  to  achieve  the 
objectives  of  the  Programme.  They  shall  ensure  that  appropriate  information  is 
provided  about  actions  supported  by  the  Programme  and  that  the  widest  possible 
participation is obtained65. 

4.1d. 

For the attainment of the objectives of the Programme, the Commission shall, in close 
cooperation with the Member States: 

(a)  pursue  the  comparability  of  data  and  information,  and  the  compatibility  and 
interoperability  of  the  systems  and  networks  for  exchange  of  data  and 
information on health66 and 

(b) 

ensure the necessary cooperation and communication with the European Centre 
for Disease Prevention and Control67. 

5.1f. 

In implementing the Programme, the Commission, together with the Member Sates, 
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 data68. 

63 
64 
65 

66 
67 
68 

EP am. 55, leaving out the sentence on ensuring harmonious and balanced development. 
EP am. 56, which COM accepted partially, leaving out the EP text “and if necessary the integration of”. 
EP  am.  57,  which  COM  accepted  partially,  leaving  out  “in  actions  requiring  implementation  through 
local and regional authorities and NGOs”. 
EP am. 59. 
EP am. 60, in its final consolidated version. 
EP am. 61. 

EN 

19 

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1. 

2. 

1. 

2. 

1. 

2. 

Article 64a 

Joint strategies and actions 

To  ensure  a  high  level  of  human  health  protection  in  the  definition  and 
implementation  of  all  Community  policies  and  activities  and  to  promote  the 
mainstreaming  of  health,  the  objectives  of  the  Programme  may  be  implemented  as 
joint  strategies  and  joint  actions  by  creating  links  with  relevant  Community 
programmes, actions and funds. 

The  Commission  shall  ensure  that  the  Programme  ties  in  optimally  with  other 
Community  programmes,  actions  and  funds,  such  as  with  the  7th  Framework 
Programme of Research and the Community Statistical Programme69. 

Article 75 

Funding 

The  financial  framework  for  the  implementation  of  the  pProgramme  for  the  period 
specified in Article 1 is EUR 1 203 million 365,6 million70.. 

Annual appropriations shall be authorised by the budgetary authority  within the limits of 
the financial frameworkperspective. 

Article 8 

Administrative and technical assistance 

The  financial  allocation  of  this  Programme  may  also  cover  expenses  pertaining  to 
preparatory,  monitoring,  control,  audit  and  evaluation  activities,  required  directly 
for  the  management  of  the  Programme  and  the  realisation  of  its  objectives,  in 
particular studies, meetings, information and publication actions, expenses linked to 
informatic  networks  focusing  on  information  exchange,  together  with  all  other 
technical  and  administrative  assistance  expense  that  the  Commission  may  have 
recourse to for the management of the Programme. 

It  may  also  cover  technical  and  administrative  assistance  expenses  necessary  to 
ensure  the  transition  between  this  Programme  and  the  measures  adopted  under 
Decision  n°  1876/2002/EC.  If  necessary,  appropriations  could  be  entered  in  the 
budget beyond 2013 to cover these expenses, to enable the management of actions not 
yet completed by 31 December 2013. 

69 
70 

EP am. 63, which COM accepted with modifications. 
EUR 324,15 million in 2004 prices. 

EN 

20 

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Article 96 

Committee 

1. 

2. 

3. 

4. 

1. 

The Commission shall be assisted by a Committee (hereinafter ‘the Committee’). 

Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall 
apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 
4(3) of Decision 1999/468/EC shall be set at two months. 

Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall 
apply, having regard to the provisions of Article 8 thereof. 

The Committee shall adopt its rules of procedure. 

Article 107 

Implementation measures 

The measures necessary for the implementation of this Decision relating to the following 
shall be adopted in accordance with the management procedure referred to in Article 96(2): 

(a) 

the annual plan of work for the implementation of the pProgramme, setting out: 

– 

– 

– 

priorities  and  actions  to  be  undertaken,  including  the  allocation  of  financial 
resources71and relevant criteria; 

criteria for the percentage of Community financial contribution; 

the arrangements for implementing the joint strategies and actions referred to 
in Article 6724a; 

(b) 

selection and award criteria for financial contributions, including those referred 
to under Article 4.4. 

2. 

The Commission shall adopt Aany other measures necessary for the implementation of this 
Decision  shall  be  adopted  in  accordance  with  the  procedure  referred  to  in  Article 
96(3)73.. The Committee shall be informed of them. 

71 
72 
73 

EP am. 66. 
EP am. 146 (with change in numbering). 
EP am. 69 with small editorial change by COM. 

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21 

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Article 118 

Participation of third countries 

The Pprogramme shall be open to the participation of: 

(a) 

(b) 

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

and third countries, in particular countries in the European neighbourhood, countries 
that are applying for, candidates for or acceding to membership of the Union, and the 
western  Balkan  countries  included  in  the  stabilisation  and  association  process,  in 
accordance  with  the  conditions  laid  down  in  the  respective  bilateral  or  multilateral 
agreements  establishing  the  general  principles  for  their  participation  in  Community 
programmes. 

Article 129 

International cooperation 

In  the  course  of  implementing  the  programmeProgramme,  relations  with  third  countries  that  are 
not  participating  in  the  programme  Programme  and  relevant  international  organisations,  in 
particular the WHO, shall be encouraged74. 

Article 130 

Monitoring, evaluation and dissemination of results 

1. 

2. 

3. 

The  Commission,  in  close  cooperation  with  the  Member  States,  shall  monitor  the 
implementation  of  the  actions  of  the  pProgramme  in  the  light  of  its  objectives.  It  shall 
report to the Committee, and shall keep the Council and Parliament informed. 

At  the  request  of  the  Commission,  Member  States  shall  submit  information  on  the 
implementation and impact of this Programme75.  

At  the  request  of  the  Commission,  Member  States  shall  submit  information  on  the 
implementation  and  impact  of  this  programme.  The  Commission  shall  submit  to  the 
European  Parliament,  the  Council,  the  European  Economic  and  Social  Committee 
and the Committee of the Regions: 

(a)  an  external  and  independent  interim  evaluation  report  on  the  results  obtained 
and  the  qualitative  and  quantitative  aspects  of  the  implementation  of  the 
Programme three years after its adoption; the report shall in particular make it 
possible  to  assess  the  impact  of  measures  on  all  countries;  the  report  shall 
contain a summary of the main conclusions and remarks by the Commission; 

74 
75 

EP am. 70. 
This corresponds to wording in the original COM proposal in this Article (initially under 10.2). 

EN 

22 

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(b)  a  Communication  on  the  continuation  of  the  Programme  no  later  than  four 

years after its adoption; 

(c)  no  later  than  31  December  2015,  an  external  and  independent  ex-post 
evaluation report covering the implementation and results of the Programme76. 

(d)  at  the  request  of  the  Commission,  Member  States  shall  submit  information  on  the 

implementation and impact of this Programme. 

The Commission shall ensure that the programme is evaluated three years after its start and 
following the end of the programme. The Commission shall communicate the conclusions 
thereof,  accompanied  by  its  comments,  to  the  European  Parliament,  the  Council,  the 
European Economic and Social Committee and the Committee of the Regions. 

The  Commission  shall  make  the  results  of  actions  undertaken  in  accordance  with  this 
Decision publicly available and shall ensure their dissemination. 

3. 

4. 

Article 141 

Repeal 

Decisions No 1786/2002/EC and No 20/2004/EC is are repealed with effect from the entry into 
force of this Decision77. 

Article 152 

Transitional administrative arrangements measures 

The  Commission  shall  adopt  any  administrative  arrangements  measures  necessary  to  ensure  the 
transition  between  the  measures  adopted  under  Decisions  No  1786/2002/EC  and  No  20/2004/EC 
and those to be implemented under theis Pprogramme.78 

Article 153 

Final provision 

This  Decision  shall  enter  into  force  on  the  day  following  that  of  its  publication  in  the  Official 
Journal of the European Union. 

76 
77 

78 

EP am. 71, shortened. 
EP(From am. 74 initially rejected by COM in GRI on grounds of split (this would leave out consumer 
legal base). 
EP (From am. 75 initially rejected by COM in GRI on grounds of split) 

EN 

23 

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Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

24 

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Annex 

1. 

Improve citizens’ health security 

1.1. Protect citizens against health threats 

1.1.1.  Develop  strategies  and  mechanisms  for  preventing,  exchanging  information  on  and 
responding  to  communicable  and  non-communicable  threats,  and  threats  from  physical, 
chemical or biological sources, including deliberate release acts; action to assure high quality 
diagnostic  co-operation  between  laboratories,  including  a  Community  reference  laboratory 
structure. 

1.1.2.  Support  the  development  of  prevention,  vaccination  and  immunisation  policies; 
improve  partnerships,  networks,  tools  and  reporting  systems  for  immunisation  status  and 
adverse events monitoring. 

1.1.3.  Develop  risk  management  capacity  and  procedures;  improve  preparedness  and 
planning  for  health  emergencies,  including  preparing  for  coordinated  EU  and  international 
responses to health emergencies; develop risk-communication and consultation procedures on 
counter-measures. 

1.1.4. Promote the co-operation and improvement of response capacity and assets, including 
protective  equipment,  isolation  facilities  and  mobile  laboratories  to  deploy  rapidly  in 
emergencies.  

1.1.5.  Developing  strategies  and  procedures  for  drawing  up,  improving  surge  capacity, 
conducting  exercises  and  tests,  evaluating  and  revising  general  contingency  and  specific 
health emergency plans and their inter-operability between Member States. 

1.2. Improve citizens’ safety 

1.2.1.  Support  and  enhance  scientific  advice  and  risk  assessment  by  promoting  the  early 
identification  of  risks;  analysing  their  potential  impact;  exchanging  information  on  hazards 
and exposure; and fostering integrated and harmonised approaches. 

1.2.2. Help to enhance the safety and quality of organs and substances of human origin, blood, 
and  blood  derivatives;  promote  their  availability,  traceability  and  accessibility  for  medical 
use. 

1.2.3. Promote measures to improve patient safety through high quality and safe healthcare, 
including in relation to nosocomial infections. 

1.2.4. Promote actions to help reduce accidents and injuries, notably household accidents. 

2. 

Promote health to improve prosperity and solidarity 

2.1. Foster healthy, active ageing and help bridge health inequalities  

2.1.1. Promote initiatives to increase healthy life years and promote healthy ageing; support 
measures to promote and explore health’s impact on productivity and labour participation as 
a contribution to meeting the Lisbon goals. 

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25 

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2.1.2.  Support  initiatives  to  address  and  reduce  health  inequalities  within  and  between 
Member States to contribute to prosperity and cohesion; promote investment in health in co-
operation  with  other  Community  policies  and  Funds;  improve  solidarity  between  national 
health systems by supporting co-operation on issues such as mobility and cross-border care. 

2.2. Promote healthier ways of life by tackling health determinants 

2.2.1.  Address  health  determinants  to  promote  and  improve  health,  creating  supportive 
environments for healthy lifestyles and preventing disease; taking action on key factors such 
as  nutrition  and  physical  activity  and  sexual  health,  and  on  addiction-related  determinants 
such  as  tobacco,  alcohol  and  drugs,  focussing  on  key  settings  such  as  education  and  the 
workplace and across the life cycle. 

2.2.2.  Support  action  on  the  health  effects  of  wider  environmental  and  socio-economic 
determinants. 

3. 

Generate and disseminate health knowledge  

3.1. Exchange knowledge and best practice  

3.1.2.  Collection  of  information  and  exchange  of  knowledge  and  best  practice  on  key  health 
issues  within  the  scope  of  the  Programme,  including  co-operation  between  health  systems, 
gender-related aspects of health, children’s health, mental health and rare diseases. 

3.2. Collect, analyse and disseminate health information  

3.2.1.  (Collection)  Develop  further  a  sustainable  health  monitoring  system  with  mechanisms 
for  collection  of  data  and  information,  with  appropriate  indicators;  Collection  of  data  on 
health  status  and  policies;  the  statistical  element  of  this  system  will  be  developed  with  the 
Community Statistical Programme. 

3.2.2.  (Analysis  and  dissemination)  Develop  mechanisms  for  analysis  and  dissemination, 
including Community health reports, the Health portal and conferences; provide information 
to  citizens,  stakeholders  and  policy  makers,  develop  consultation  mechanisms  and 
participatory processes; regular report on Health Status in the European Union based on all 
data and indicators and including a qualitative and quantitative analysis79. 

3.2.3.  Analysis  and  technical  assistance  in  support  of  the  development  or  implementation  of 
policies or legislation related to the scope of this Programme. 

79 

Wording on the report stems from EP am. 73 accepted by COM with modifications (“regularly” instead of 
“every two years”). 

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26 

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ANNEX 1 – Strengthening synergies through common actions and instruments 

Objectives 

To  protect  citizens  from  risks  and  threats  that  are  beyond  the  control  of  individuals  (e.g. 

1. 
health threats which affect the society as a whole, unsafe products, unfair commercial practices). 

To increase the ability of citizens to take better decisions about their health and consumer 

2. 
interests.  

3. 

To mainstream health and consumer policy objectives. 

Actions and instruments 

1. 

Improve communication with EU citizens on health and consumer issues 

1.1.  Awareness-raising campaigns. 

1.2. 

Surveys. 

1.3.  Conferences, seminars, experts and stakeholders meetings. 

1.4. 

Publications on issues of interest for health and for consumer policy. 

1.5. 

Provision of online information. 

1.6.  Developing and use of information points. 

Increase civil society and stakeholders’ participation in policy-making related to health and 

2. 
consumer protection 

2.1. 

Promote and strengthen Community level consumer and health organisations. 

2.2. 

Training and capacity-building for consumer and health organisations.  

2.3.  Networking of non-governmental consumer and health organisations and other stakeholders. 

2.4. 

Strengthening of Community-level consultative bodies and mechanisms. 

Develop  a  common  approach  for  integrating  health  and  consumer  concerns  into  other 

3. 
Community policies 

3.1.  Development  and  application  of  methods  to  assess  the  impact  of  Community  policies  and 
activities on health and consumer interests. 

3.2. 

Exchange best practice with Member States on national policies. 

3.3. 

Studies on impact of other policies on health and consumer protection. 

4. 

Promote international co-operation related to health and consumer protection 

4.1.  Co-operation measures with international organisations. 

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27 

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4.2.  Co-operation measures with third countries who are not participating in the programme. 

4.3. 

Encourage health and consumer organisations’ dialogue. 

5. 

Improve the early detection, evaluation and communication of risks by: 

Supporting  scientific  advice  and  risk  evaluation,  including  the  tasks  of  the  independent 

5.1. 
scientific committees established by Commission Decision 2004/210/EC80. 

The collection and collation of information and establishment of networks of specialists and 

5.2. 
institutes.  

5.3. 

Promoting the development and harmonisation of risk assessment methodologies. 

5.4.  Actions  for  collecting  and  assessing  information  on  the  exposure  of  populations  and  sub-
groups to chemical, biological and physical hazards to health. 

Establishing mechanisms concerning early detection of emerging risks and action on newly 

5.5. 
identified risks. 

5.6. 

Strategies to improve risk communication.  

5.7. 

Training in risk assessment.  

6. 

Promote the safety of goods and of substances of human origin 

6.1.  Analysis of injury data and development of best practice guidelines in relation to the safety 
of consumer products and services.  

6.2.  Development of methodologies and database maintenance for the purpose of data collection 
on injuries in relation to the safety of consumer products. 

6.3.  Activities to help enhance the safety and quality of organs and substances of human origin, 
including blood, blood components and blood precursors. 

Promoting the availability and accessibility across the Community of organs and substances 

6.4. 
of human origin of high quality and safety for medical treatments. 

6.5. 
Technical  assistance  for 
implementation of policies and legislation. 

the  analysis  of 

issues  related 

to 

the  development  and 

80 

OJ L 66, 4.3.2004, p. 45. 

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28 

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ANNEX 2 - HEALTH 

ACTIONS AND SUPPORT MEASURES 

Objective one: protect citizens against health threats 

1. 

Enhance surveillance and control of health threats by 

1.1.1.  Enhancing  the  capacity  to  tackle  communicable  diseases  by  supporting  the  further 
implementation  of  Decision  No  2119/98/EC  on  the  Community  network  on  the  epidemiological 
surveillance  and  control  of  communicable  diseases,  and  by  ensuring  coherence  with  the  action  of 
the  ECDC  taking  into  account  the  activities  of  the  European  Centre  for  Disease  Prevention  and 
Control; 

1.1.2.  Developing  strategies  and  mechanisms  for  preventing,  exchanging  information  on  and 
responding to non-communicable disease threats; 

1.1.3.  Exchanging  information  on  strategies  and  developing  joint  strategies  to  detect  and  obtain 
reliable information on health threats from physical, chemical or biological sources, including those 
relating  to  deliberate  release  acts,  and  developing  and  using,  when  appropriate,  Community 
approaches and mechanisms in coordination with the European Centre for Disease Prevention and 
Control; 

1.1.4.  Improving  laboratory  co-operation  to  assure  high  quality  diagnostic  capabilities  for 
pathogens  across  the  Community,  including  a  Community  reference  laboratory  structure  for 
pathogens requiring enhanced Community collaboration; 

1.1.5.  Developing  new  and  improved  prevention,  vaccination  and  immunisation  policies, 
partnerships and tools and monitoring immunisation status; 

1.1.5a  Monitoring  the  resistance  of  bacteria  to  antibiotics  and  of  nosocomial  infections,  and 
developing strategies to prevent and treat them and developing strategies to address them; 

1.1.6.  Developing and implementing vigilance networks and reporting systems for adverse events 
when using preventive health measures and substances of human origin; 

1.1.7.  Technical  assistance  for 
implementation of policies and legislation.  

the  analysis  of 

issues  related 

to 

the  development  and 

1.2.  Deliver response to health threats by 

1.2.1.  Elaborating  risk  management  procedures  for  health  emergencies,  including  procedures  for 
mutual assistance in the event of pandemics, and enhancing capability for coordinated responses to 
health emergencies; 

1.2.2.  Developing  and  maintaining  capacity  for  appraising  and  addressing  the  needs  and  gaps  in 
preparedness and response and for rapid and reliable communications and consultation on counter-
measures; 

1.2.3.  Developing  risk  communication  strategies  and  tools  for  information  and  guidance  to  the 
public, and health professionals, and improving awareness and interaction among actors; 

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29 

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1.2.4.  Developing  strategies  and  procedures  for  drawing  up,  testing,  evaluating  and  revising 
general  contingency  and  specific  health  emergency  plans  and  their  inter-operability  between 
Member States and conducting exercises and tests; 

1.2.5.  Developing  strategies  and  mechanisms  for  reviewing  and  improving  the  availability  and 
adequacy  of,  and  access  to  facilities  (e.g.  laboratories)  and  equipment  (detectors  etc),  as  well  as 
readiness, surge capacity and infrastructure of the health sector to react rapidly; 

1.2.6.  Developing  strategies  and  mechanisms  for  assessing  the  need  for  and  promoting  the 
establishment  of  public  health  assets  that  can  be  deployed  rapidly  in  emergencies  and  setting-up 
mechanisms  and  procedures  for  health  assets  transfer  to  requesting  states  and  international 
organisations; 

1.2.7.  Establishment and maintenance of a trained and permanently available core group of public 
health  experts  for  global  rapid  deployment  to  places  of  major  health  crises  together  with  mobile 
laboratories, protective equipment and isolation facilities. 

Objective 2: promote policies that lead to a healthier way of life 

3. 

Promote health by tackling determinants  

Actions  will  support  the  preparation,  development  and  implementation  of  activities, 

strategies and measures on health determinants by addressing: 

3.1.  Health  determinants  linked  to  addictions,  notably  tobacco,  alcohol  and  drugs  and  other 
addictive substances;3 2.1a  Practices which lead to a healthier life, in order to improve children’s 
health; 

32.2.  Lifestyle  related  health  determinants,  notably  nutrition  and  physical  activity,  sexual  health 
and reproductive health; 

32.2a  Injury-related health determinants; 

32.3.  Social and economic determinants of health, with a particular focus on inequalities in health, 
and on the impact of social and economic factors  on  health, and on discrimination against with a 
particular focus on vulnerable groups; 

32.4.  Environmental  determinants  of  health,  with  a  particular  emphasis  on  the  health  impact  of 
environmental factors; 

32.5.  The quality, efficiency and cost effectiveness of public health interventions;  

32.5e  Gender and age aspects of health; 

32.6.  Support for public awareness activities, training and capacity building actions related to the 
priorities set out in the previous paragraphs; 

32.7.  Technical  assistance  for 
implementation of policies and legislation. 

the  analysis  of 

issues  related 

to 

the  development  and 

Objective  3:  contribute  to  reducing  the  incidence,  morbidity  and  mortality  of  major  diseases  and 
injuries 

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30 

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43. 

Prevent diseases and injuries  

In coordination with work on health determinants, the programme Programme shall support:  

43.1.  Development and implementation of actions on major diseases of particular significance in 
view  of  the  overall  burden  of  disease  and  of  the  main  causes  of  potential  life  years  lost  and 
incapacities  in  the  Community  where  Community  action  can  provide  significant  added  value  to 
national efforts;  

43.2.  Preparation  and  implementation  of  strategies  and  measures  on  disease  prevention,  in 
particular  by  identifying  best  practice  and  developing  guidelines  and  recommendations,  including 
on secondary prevention, screening and early detection; 

43.2a  Preparation  of  strategies  and  measures  on 
recommendations for their implementation; 

immunisation  and  vaccination  and 

43.3.  Exchange  of  best  practice  and  knowledge  as  well  as  the  coordination  of  strategies  to 
promote mental health and to prevent mental illness; 

43.3b  Promotion of best practise for diseases and injuries in order to prevent further deterioration 
of health; 

43.4.  Preparation and implementation of strategies and measures on prevention of injuries, based 
on the analysis of injury determinants; 

43.4a  Development of best practise and guidelines on injuries based on the analysis of collected 
data; 

Support  for  knowledge  exchange,  training  and  capacity  building  actions  related  to  the 

4.5. 
diseases addressed and injury prevention. 

Objective 4: improving effectiveness and efficiency in health systems 

54. 

Achieve synergies between national health systems by 

54.1.  Facilitating  cross-border  healthcare  purchasing  and  provision,  including  information 
gathering and exchange to enable sharing of capacity and use of cross-border care;  

54.2.  Collecting data and Ssharing information on and managing the consequences of the mobility 
of health professionals and promoting policies on patient mobility; 

54.3.  Establishing  a  Community  system  for  cooperation  on  centres  of  reference  and  other 
collaborative  structures  between  health  systems  of  more  than  one  Member  State  which  would 
promote  enable  doctors  and  other  healthcare  practitioners  to  apply  best  practices  and  best 
knowledge on prevention and treatment available within the EU;  

54.4.  Developing a network for strengthening the capacity to develop and share information and 
assessments regarding health technologies and techniques (health technology assessment); 

54.5.  Providing information for patients, professionals and policy-makers, on health systems and 
medical  care  in  liaison  with  overall  health  information  actions,  and  including  mechanisms  for 

EN 

31 

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sharing  and  disseminating  information  with  the  action  plan  for  a  European  e-health  area,  while 
establishing strict helping to promote quality criteria for health-related websites; 

54.6.  Developing instruments for assessing the impact of Community policies on health systems, 
including the consequences of enlargement and the Lisbon strategy; 

54.7.  Developing and implementing actions to promote patient safety and high-quality care; 

54.7a  Promoting  the  availability,  traceability  and  accessibility  across  the  Community  of  organs 
and substances of human origin of high quality and safety for medical use; 

54.8.  Supporting  health  systems  policy  development,  in  particular  linked  to  the  open  method  of 
coordination on healthcare and long-term care. 

Actions and instruments contributing to all the above objectives:  

5. 

Data Collection, Health Monitoring And Information 

65.1.  To improve health information and knowledge for the development of public health byData 
collection, health monitoring and dissemination of information: 

65.1.1. Continue further developing a sustainable health monitoring system, paying special attention 
to  health  inequalities  and  covering  data  on  health  status,  health  determinants,  health  systems  and 
injuries;  the  statistical  element  of  this  system  will  be  further  developed,  using  as  necessary  the 
Community Statistical Programme. 

65.1.1b 
Collecting and analysing data on lifestyle related factors (e.g. nutrition and tobacco 
and alcohol consumption) and injuries, establishing Europe-wide registries for major diseases (e.g. 
cancer), and developing methodologies and database maintenance; 

65.1.2. Providing other relevant health related knowledge; 

65.1.3. Defining relevant additional indicators; 

65.1.4. Developing appropriate mechanisms of reporting; 

65.1.5. Arranging  for  regular  collection  of  such  information,  together  with  the  Statistical 
Programme, international organisations, agencies and through projects; 

65.1.6. Supporting analysis of Community health issues through regular Community health reports, 
the  maintenance  of  diffusion  mechanisms  such  as  the  Health  Portal,  support  for  consensus 
conferences and targeted information campaigns coordinated between concerned parties; 

65.1.7. Focusing on providing a  regular  and  reliable  source  of  information to citizens, to decision 
makers, to patients, carers, health professionals and to other interested parties; 

65.1.8. Developing  strategies  and  mechanisms  for  preventing,  exchanging  information  on  and 
responding to rare diseases. 

5.2.  Cooperation and integration 

5.4.  Risks, safety and horizontal issues 

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5.6. 

Improve the early detection, evaluation and communication of risks by: 

5.6.1.  Supporting  scientific  advice  and  risk  evaluation,  including  the  tasks  of  the  independent 
scientific committees established by Commission Decision 2004/210/EC1. 

5.6.2.  Collection  and  collation  of  information  and  establishment  of  networks  of  specialists  and 
institutes. 

5.6.3. Promoting the development and harmonisation of risk assessment methodologies. 

5.6.4.  Actions  for  collecting  and  assessing  information  on  the  exposure  of  populations  and  sub-
groups to chemical, biological and physical hazards to health, including the effects of such hazards. 

5.6.5. Establishing mechanisms concerning early detection of emerging risks and action on newly 
identified risks. 

5.6.6. Strategies to improve risk communication. 

5.8.  Horizontal issues  

Technical  assistance  for  the  analysis  of  issues  related  to  the  development  and  implementation  of 
policies and legislation 

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33 

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ANNEX 3: Consumer Policy – Actions and Support Measures 

Objective I - A better understanding of consumers and markets 

Action 1: 
Monitoring and assessment of market developments with an impact on the economic 
and  other  interests  of  consumers,  including  price  surveys,  inventory  and  analysis  of  consumer 
complaints, analysis of cross-border marketing and business-to-consumer purchases, and surveys of 
changes in the structure of markets. 

Action 2: 
The collection and exchange of data and information that provide an evidence base 
for  the  development  of  consumer  policy  and  for  the  integration  of  consumer  interests  in  other 
Community policies, including, surveys of consumer and business attitudes, consumer-related and 
other market research in the financial services area, collection and analysis of statistical and other 
relevant data, the statistical element of which will be developed using as necessary the Community 
Statistical Programme. 

Action 3: 
provide a scientific evidence base on consumer exposure to chemicals released from products. 

The collection, exchange, analysis of data and development of assessment tools that 

Objective II - Better consumer protection regulation 

Action 4: 
regulatory initiatives, including: 

Preparation  of  legislative  and  other  regulatory  initiatives  and  promotion  of  self-

4.1.  Comparative analysis of markets and regulatory systems 

4.2. 

Legal and technical expertise for policy making on the safety of services 

Technical expertise in relation to assessment of the need for product safety standards and the 

4.3 
drafting of CEN standardisation mandates for products and services 

Legal  and  technical  expertise  for  policy  development  on  the  economic  interests  of 

4.4 
consumers 

4.5  Workshops with stakeholders and experts. 

Objective III - Better enforcement, monitoring and redress 

Action 5: 
consumer protection legislation, including: 

Coordination  of  surveillance  and  enforcement  actions  linked  to  the  application  of 

Development and maintenance of IT tools (e.g. databases, information and communication 

5.1 
systems)  

5.2. 

Training, seminars, conferences on enforcement 

5.3. 

Planning and development of joint enforcement actions 

5.4. 

Pilot joint enforcement actions 

5.5.  Analysis of enforcement problems and solutions 

EN 

34 

  EN 

 
Financial  contributions  for  specific  joint  surveillance  and  enforcement  actions  to 
Action 6: 
improve  administrative  and  enforcement  cooperation  on  Community  consumer  protection 
legislation,  including  the  General  Product  Safety  Directive,  and  other  actions  in  the  context  of 
administrative cooperation. 

Action 7: 
including: 

Monitoring  and  assessment  of  the  safety  of  non-food  products  and  services, 

7.1.  Reinforcement and extension of the scope and operation of the RAPEX alert system, taking 
developments in market surveillance information exchange into account 

7.2. 

Technical analysis of alert notifications 

7.3.  Collection  and  assessment  of  data  on  the  risks  posed  by  specific  consumer  products  and 
services 

Further  development  of  the  consumer  product  safety  network  as  provided  for  in  Directive 

7.4. 
2001/95/EC of the European Parliament and of the Council81.  

Action 8: 
resolution schemes on consumers. 

Monitoring  of  the  functioning  and  assessment  of  the  impact  of  alternative  dispute 

Action 9: 
Monitoring  of  the  transposition  and  implementation  of  consumer  protection 
legislation by Member States, notably the Unfair Commercial Practices Directive, and of national 
consumer policies. 

Action 10: 
support their contribution to enforcement and surveillance actions. 

Provision  of  specific  technical  and  legal  expertise  to  consumer  organisations  to 

Objective IV. Better informed and educated and responsible consumers 

Action 11: 
the application of and case-law on Community consumer protection legislation.  

Development and maintenance of easily and publicly accessible databases covering 

Action 12: 
Member States, in cooperation with their consumer organisations.  

Information  actions  about  consumer  protection  measures,  particularly  in  the  new 

Action 13: 
development of interactive consumer education tools. 

Consumer  education,  including  the  actions  targeted  at  young  consumers,  and  the 

Action 14: 
including international standardisation bodies and international trade organisations.  

Representation  of  the  interests  of  Community  consumers  in  international  forums, 

Action 15: 
organisations and other capacity building actions. 

Training  for  staff  members  of  regional,  national  and  Community  consumer 

Action 16: 
Financial contributions for joint actions with public or non-profit bodies constituting 
Community networks  that provide information and assistance to consumers to help them exercise 

81 

OJ L 11, 15.1.2002, p. 4. 

EN 

35 

  EN 

 
                                                 
their  rights  and  obtain  access  to  appropriate  dispute  resolution  (the  European  Consumer  Centres 
Network). 

Action 17: 
Financial  contributions  to  the  functioning  of  Community  consumer  organisations 
representing  consumer  interests  in  the  development  of  standards  for  products  and  services  at 
Community level. 

Action 18: 

Financial contributions to the functioning of Community consumer organisations. 

Action 19: 
Provision  of  specific  technical  and  legal  expertise  to  consumer  organisations  to 
support their participation in, and input into, consultation processes on Community legislative and 
non-legislative policy initiatives, in relevant policy areas, such as internal market policies, services 
of  general  interest  and  the  10-year  framework  programme  on  sustainable  production  and 
consumption.  

Common to all objectives 

Action 20: 
support of other consumer policy objectives. 

Financial  contributions  for  specific  projects  at  Community  or  national  level  in 

EN 

36 

  EN 

 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL : 

Health programme (2007-2013) 

2. 

ABM / ABB FRAMEWORK 

Policy area: Health and Consumer Protection (SANCO, Title 17) 

Activities: Public health: 

3. 

BUDGET LINES 

3.1.  Budget lines (operational lines and related technical and administrative assistance lines 

(ex- B..A lines)) including headings : 

Current budget lines: 

ABB 17 03 06 Community action in the field of Health and Consumer protection — 
Public health 

ABB 17 01 04 06 : Public Health – Expenditure for Administrative management 

ABB 17 01 04 30 : Public health –Operating subsidy to the Executive Agency for the 

Public Health Programme. 

A  new  budget  structure  will  be  defined  after  approval  of  the  Interinstitutional 
Agreement on Financial Framework 2007-2013. 

3.2.  Duration of the action and of the financial impact: 

Total allocation for action : 365,6 € million for commitment 

Period  of  application:  day  of  entry  into  force  of  the  decision  in  2007  –  31  December 
2013 

EN 

37 

  EN 

 
 
 
 
 
 
 
3.3.  Budgetary characteristics: 

Budget lines 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from associated 
countries 

Heading in 
financial 
framework 

17 03 06  

Non-comp 

diff 

17 01 04 06 

Non-comp 

Non-diff 

17 01 04 30 

Non-comp 

Non-diff82 

NO 

NO 

NO 

YES 

YES 

YES 

YES 

YES 

YES 

No 3b 

No 3b 

No 3b 

4. 

SUMMARY OF RESOURCES 

4.1.  Financial Resources 

4.1.1. Summary of commitment appropriations (CA) and payment appropriations (PA) 

2007 

2008 

2009 

2010 

2011 

2012 

2013 and 
later 

Total 

EUR million (to 3 decimal places) 

Expenditure 
type 

Sec-
tion 
no. 

Operational 
expenditure[1] 

Commitment 
Appropriations 
(CA) 

Payment 
Appropriations 
(PA) 

8.1 

a 

38,80 

45,20 

47,00 

45,70 

47,30 

49,70 

51,50 

325,20 

b 

11,64 

25,20 

39,30 

45,25 

46,52 

47,51 

109,78 

325,20 

Administrative expenditure within reference amount[2] 

Technical & 
administrative 
assistance 
(NDA) 

8.2.4 

c 

TOTAL REFERENCE AMOUNT 

5,30 

5,50 

5,80 

5,70 

5,90 

6,00 

6,20 

40,40 

Commitment 
Appropriations 

Payment 
Appropriations 

a+c 

44,10 

50,70 

52,80 

51,40 

53,20 

55,70 

57,70 

365,60 

16,94 

30,70 

45,10 

50,95 

52,42 

53,51 

115,98 

b+c 

365,60 

Administrative expenditure not included in reference amount[3] 

82 

Non-differentiated appropriations hereafter referred to as NDA. 

EN 

38 

  EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
                                                 
5,18 

5,18 

5,18 

5,18 

5,18 

5,18 

5,18 

36,29 

3,10 

3,11 

3,13 

3,14 

3,16 

3,17 

3,19 

15,66 

Human 
resources and 
associated 
expenditure 
(NDA) 

Administrative 
costs, other 
than human 
resources and 
associated 
costs, not 
included in 
reference 
amount (NDA) 

8.2.5 

d 

8.2.6 

e 

[1] Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 

[2] Expenditure within article xx 01 
04 of Title xx. 

[3] Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

Total indicative financial cost of 
intervention  

total 

TOTAL CA 
including cost 
of Human 
Resources 

TOTAL PA 
including cost 
of Human 
Resources 

a+c+d+e 

b+c+d+e 

52,38 

58,994 

61,11 

59,726 

61,541 

64,057 

66,073 

423,88 

25,22 

38,993 

53,411 

59,276 

60,762 

61,867 

124,353 

423,88 

EN 

39 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Co-financing details 

Not applicable 

4.1.2. Compatibility with Financial Programming 

X 

Proposal is compatible with Financial Framework 2007-2013. 

4.1.3. Financial impact on Revenue 

X 

Proposal has no financial implications on revenue 

4.2.  Human  Resources  FTE  (including  officials,  temporary  and  external  staff)  –  see  detail 

under point 8.2.1. 

Annual requirements 

2007 

2008 

2009 

2010 

2011 

2012 

2013 

Total number of human 
resources* 

48 

48 

48 

48 

48 

48 

48 

* 

of which 2 new posts in 2007, covered within the pre-allocation of the Directorate General in the PDB for 2007 

EN 

40 

  EN 

 
5. 

CHARACTERISTICS AND OBJECTIVES: 

5.1.  Need to be met in the short or long term 

The need is identified in the explanatory memorandum. 

5.2.  Value  added  of  Community  involvement  and  coherence  of  the  proposal  with  other 

financial instruments and possible synergy 

The  EU,  national  and  regional  authorities,  citizens,  businesses  and  civil  society  have  a 
role to play in improving the health, wellbeing and welfare of European citizens. There 
are  however  several  health  policy  challenges  that  only  action  at  EU  level  can  tackle. 
Greater  mobility  and  more  communication  have  benefited  citizens.  But  they  have  also 
increased  the  risk  of  spreading  health  threats  such  as  SARS  and  other  communicable 
diseases  (which  cannot  be  addressed  by  individual  Member  States  alone).  The 
complexity of modern life has brought more choice for citizens. But it has also made it 
harder for them to make the best choices.  

The  proposed  strategy  and  programme  aim  to  implement  article  152  of  the  Treaty  as 
regards  Community  action  on  health,  by  complementing  national  action  with  value-
added measures which cannot be taken at national level.  

The  Health  programme  builds  on  the  existing  programme  and  maintains  its  core 
elements.  In  addition,  it  aligns  future  health  action  more  explicitly  with  the  overall 
Community objectives of prosperity, solidarity and security and with the Lisbon agenda 
in particular, and seeks to further exploit synergies with other policies. 

Synergies  will  be  ensured  with  other  major  instruments.  For  example  health  has  been 
more  closely  associated  to  the  Structural  Funds  and  the  research  programme  when 
designing the new legal base. Particular attention has also been given to ensure synergies 
with the Solidarity Fund. 

5.3.  Objectives and expected results of the proposal in the context of the ABM framework 

The general objective of the ABM “public health” activity is to aim for a high level of 
human  health  protection  in  the  development  and  implementation  of  all  Community 
policies, 
integrated  health  strategy,  notably  by 
implementation of the multi-annual health programme, and to enhance the capability of 
the EU to address, in a timely and coordinated fashion, threats to public health. 

the  promotion  of  an 

through 

The objectives of the proposal are identified in the explanatory memorandum.  

The expected results are: 

1.  Improved  health  security,  in  particular  increased  capacity  at  European  and  national 
level  to  respond  to  cross-border  health  threats  and  also  to  contribute  to  strengthened 
health-related safety across the EU (for example to fulfil the Treaty mandate as regards 

EN 

41 

  EN 

 
 
 
 
 
 
 
 
 
 
safety  and  quality  of  substances  of  human  origin  for  medical  use,  or  as  regards  the 
assessment of risks to citizens’ health). 

2. Stronger health promotion at European level. This would include effective measures 
to  encourage  healthy  ageing,  greater  awareness  of  health’s  impact  on  productivity  and 
growth,  a  narrowing  of  the  health  gap  across  the  EU,  in  particular  concerning 
improvement  in  health  status  in  the  new  Member  States.  The  programme  should  also 
result  in  healthier  ways  of  life  across  the  EU,  a  greater  awareness  about  the  impact  of 
lifestyles and addictions on health, and a set of solutions developed through exchange of 
good practice. By acting on the most important health determinants, the programme will 
have the result of helping to reduce the disease burden.  

3. More and better health knowledge, more dissemination. The programme will result in 
a  health  knowledge  system,  with  more  comparable  data  and  indicators,  higher  -quality 
analysis, and effective dissemination to stakeholders. The programme will further result 
in Member States taking inspiration from best practice identified through the programme 
to improve their health systems. 

5.4.  Method of Implementation (indicative) 

Show below the method(s)83 chosen for the implementation of the action. 

X 

Centralised Management 

X 

ٱ 

Directly by the Commission 

Indirectly by delegation to: 

X 

ٱ 

Executive Agency 

Bodies  set  up  by  the  Communities  as  referred  to  in  art.  185  of  the 
Financial Regulation 

ٱ 

National public-sector bodies/bodies with public-service mission 

ٱ 

Shared or decentralised management 

ٱ  With Member states 

ٱ  With Third countries 

X 

Joint management with international organisations 

83 

If more than one method is indicated please provide additional details in the "Relevant comments" section of 
this point. 

EN 

42 

  EN 

 
 
 
 
                                                 
6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

The  Commission  will  monitor 
the 
implementation of the new programme. The indicators listed are related to the objectives 
described under part 5.3 . 

the  most  pertinent 

throughout 

indicators 

Objectives  

Indicators 

1. Improve citizens’ health security  

1.1. Protect citizens against health threats 

Number of projects in this area 

Number of beneficiaries 

ECDC fully operational  

Increased European co-ordination capacity for responding rapidly to 
threats  

Increased Member States’ capacity to address health threats 

1.2. Improve citizens’ safety 

Number of scientific opinions given 

Community initiatives embodying the scientific opinions 

Number of projects on patient safety/ high quality and safe healthcare 

Number of projects on accidents and injuries 

Number of initiatives on organs / substances of human origin. 

2. Promote health to improve prosperity and solidarity 

2.1.Foster healthy, active ageing and help bridge health 
inequalities  

Number of projects on healthy ageing 

Number of initiatives on health’s impact on growth and economic 
development 

Number of measures to bridge inequalities between Member States; 
number of projects benefiting the new Member States 

Number of projects to improve solidarity between national health 
systems 

2.2. Promote healthier ways of life by tackling health 
determinants. 

Number of new measures proposed and carried out  

Number of projects in this area 

Number of thematic platforms created 

Number of information, publications and target audience reached 

EN 

43 

  EN 

 
 
 
 
 
 
 
3. Generate and disseminate health knowledge  

3.1. Exchange knowledge and best practice  

Number of projects in this area 

Number of best practice solutions identified 

Number of Member States that took inspiration from good practice to 
introduce improvements in their health systems 

Number of health themes addressed 

3.2. Collect, analyse and disseminate health information. 

Number of projects in this area 

Number of information/awareness raising publications and target 
audience reached 

Number of hits of health portal 

Number of Health reports and other publications 

Number of conferences & participants 

The implementation of the Community programme entrusted to the executive agency is subject 
to  the  control  of  the  Commission  and  this  control  is  exerted  according  to  the  methods,  the 
conditions, the criteria and the parameters which it lays down in the act of delegation defined 
by Council Regulation (EC) N° 58/2003 laying down the statute for executive agencies to be 
entrusted with certain tasks in the management of Community programmes84, Article 6 (3).  

6.2.  Evaluation 

6.2.1. Ex-ante evaluation 

This programme proposal is built on a series of existing Community programme 
and  measures,  some  of  which  have  been  operational  for  many  years,  and  which 
have  been  the  subject  of  a  comprehensive  sequence  of  evaluations,  as  well  as  a 
substantial  corpus  of  experience  of  administering  and 
the 
programmes  in  the  Commission  (and  a  former  technical  assistance  office)  and 
within  the  Member  States  and  other  participating  countries  (particularly  the 
candidate countries). 

implementing 

The hypothesis of taking no action was considered:  

• 

• 

No action means failure to meet the provisions of articles 152 of the Treaty. 

No  action  means  that  the  Commission  would  not  meet  the  requirement  of 
having a proper legal basis for health actions during the period 2007-2013 as 
imposed by the new financial framework. (The Health Programme expires 
at the end of 2008). This would make it very difficult to fulfil various legal 
obligations. 

84 

OJ L 11, 16.1.2003, p. 1.  

EN 

44 

  EN 

 
 
 
 
 
                                                 
• 

No action would mean that the Commission would not fulfil its commitment 
to  present  a  health  strategy,  following  an  open  consultation  in  2004, 
intended to help prepare the ground for a new strategy. In terms of effects on 
health, some serious negative impact would arise following the expiry of the 
in  Europe  would  be 
current  health  programme.  Health  protection 
undermined  as  essential  health  threat  alert  mechanisms  would  find  it 
difficult to operate. There would be inadequate information about important 
health  trends  and  developments  as  mechanisms  to  collect  and  analyse  the 
data  would  not  function  effectively.  This  would  make  it  harder  for  health 
authorities  to  plan  and  develop  policies  and  for  citizens  to  take  decisions. 
There would also be a great reduction in actions against trans-frontier health 
threats eg HIV/AIDS and bioterrorism. 

• 

No  action  would  also  mean  that  the  Commission  stopped  work  in  areas  of 
central  concern  to  its  citizens  daily  lives  and  thus  lost  the  possibility  to 
increase visibility and to demonstrate the relevance of its action to them. 

Building a new programme will bring citizens’ issues to the forefront of the 
EU  agenda  by  providing  a  new  framework  for  a  policy  that  impacts  on 
citizens’ day-to-day life. 

In  addition  the  existing  executive  agency  for  the  public  health  programme 
would have its current mandate adapted to be able to ensure the management 
tasks  of  the  new  programme,  including  budgetary  tasks,  which  would 
constitute 
the 
the  best  management 
Commission85. This will in particular ensure : 

the  disposal  of 

instrument  at 

–  Multiplier  effect  (leverage)  enabling  the  Commission  to  concentrate 

on its core competencies; 

– 

– 

– 

Effectiveness  and  flexibility  in  the  implementation  of  outsourced 
tasks; 

Simplification of the procedures used; 

Proximity of the outsourced action to the final beneficiaries. 

The  public  health  programme  2003-2008,  adopted  in  September  200286,  represents  a 
major  step  forward  for  the  implementation  of  the  provisions  of  Article  152  of  the  EC 
Treaty. It provides for the integrated development of a strategy aimed on the one hand at 
ensuring a high level of health protection in all Community policies and actions and, on 
the  other,  at  supplementing  and  coordinating  policies  and  actions  carried  out  by  the 
Member  States  in  the  field  of  health  surveillance  and  information  systems,  combating 
transmissible diseases and disease prevention. 

In designing the new joint programme proposal, special attention was given to building 
upon  the  experience  acquired  during  the  first  years  of  operation  of  the  2003-2008 

85 

86 

See also the study "Cost-effectiveness assessment of externalisation of European Community' s public health 
action programme" by Eureval-C3E, of 21.6.2002. 
Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a 
programme of Community action in the field of public health (2003-2008), OJ L 271, 9/10/2002. 

EN 

45 

  EN 

 
 
 
 
 
                                                 
programme, as well as to integrating the work carried out in various consultations, fora 
and groups. 

Preparatory work on the health strategy 

An  open  consultation  on  the  future  Health  Strategy  was  launched  in  July 2004.  The 
consultation was carried out on the basis of a public consultation document published on 
the  web-site.  All  interested  parties  from  the  public  health  area,  public  bodies,  interest 
groups and individual citizens, were invited to participate in the consultation, by means 
of  a  written  contribution.  Almost  200  contributions  from  national  and  regional 
authorities,  NGOs,  universities,  individual  citizens  and  companies  have  reached  the 
Commission,  Following  the  analysis  of  the  results,  a  number  of  policy  priority  areas 
have been identified making it necessary to re-orient existing work in order to refine the 
policy priorities. The result is available in the Commission website87.  

Approximately  1/4  of  all  respondents  including  Ireland,  Sweden,  the  Netherlands, 
Germany,  the  UK,  Lithuania  Malta  and  Poland  urged  the  EU  to  pro-actively  promote 
health and prevent illness. Measures proposed include the need to focus on children and 
teenagers,  to  implement  a  nutrition/obesity  strategy,  to  tackle  smoking  and  alcohol,  to 
address a wide range of issues affecting health and to act on important diseases including 
cancer, respiratory and cardiovascular diseases. 

Approximately  1/5  of  all  respondents  including  France,  Germany,  Ireland,  the 
Netherlands,  Sweden,  Finland  and  Lithuania  asked  the  EU  to  mainstream  health. 
Respondents  urged  the  Commission  to  implement  a  comprehensive  and  coherent  EU 
approach  to  health,  encompassing  policies  as  diverse  as  Education,  Trade,  Internal 
Market,  Social,  Environment,  Agriculture,  External,  Transport  and  Regional 
development. Several respondents including France, Ireland, Sweden and Finland raised 
the need for a Health Impact Assessment system.  

The need to position health as a driver of economic growth and to disseminate evidence 
was  raised  by  Ireland,  France,  the  Netherlands,  Malta  and  the  UK.  Some  NGOs  and 
Germany, Ireland and Sweden asked for health to become part of the Lisbon agenda. 

Many stressed  the  need to  address  health  inequalities  by  increasing  funding  for  health. 
Respondents also urged the EU to involve stakeholders more closely in policy-making, 
to support the civil society, to take a stronger role on international health and to step up 
efforts in the analysis and dissemination of data.  

Finally,  many  respondents  also  urged  the  EU  to  increase  resources  allocated  to  health, 
for  the  Public  Health  Programme  to  better  serve  policy  priorities,  to  improve 
dissemination  of  project  results,  to  cover  neighbouring  countries  and  to  increase  co-
funding.  

Respondents  raise  a  large  number  of  additional  specific  issues  including  the  need  to 
focus more on mental health, the challenges posed by an ageing population, the need to 
increase quality in healthcare, to secure patients’ rights and safety, to set clear rules for 
patient and professional mobility, for health technology assessment and research.  

Health systems  

87 

http://europa.eu.int/comm/health/ph_overview/strategy/reflection_process_en.htm. 

EN 

46 

  EN 

 
 
 
 
 
 
 
 
 
 
                                                 
In 2003, a high level reflection process on patient mobility and healthcare developments 
in the EU was launched at ministerial level. Working groups composed of Member State 
health ministers or senior representatives, and stakeholders met throughout the year. In 
December 2003, a ministerial level meeting including ministers from acceding countries, 
adopted  a  report  containing  19  recommendations  for  action  at  EU  level.  The 
Commission  responded  in  presenting  three  Communications88  in  April 2004.  To  take 
forward  these  recommendations,  a  High  Level  Group  on  health  services  and  medical 
care  was  established  with  working  groups  on  the  following  areas  :  cross-border 
healthcare  purchasing  and  provision,  health  professionals,  centres  of  reference,  health 
technology  assessment,  information  and  e-health,  health  impact  assessment  and  health 
systems,  patient  safety.  Reports  setting  out  progress  and  orientations  for  future  work 
were endorsed by the Council in December 2004 and in December 2005. 

Involvement of stakeholders 

Health policy making must respond to the needs and concerns of citizens. It is necessary 
to build up the organisations representing patients and those developing the public health 
agenda so that civil society is able to make the constructive contribution needed to public 
health policy.  

Currently, patient groups and non governmental organisations in the health field can find 
it difficult to develop initiatives at EU level and to stabilise their organisations because 
they have inadequate resources.  

For  example  active  participation  in  the  EU  Health  policy  forum,  which  brings 
stakeholders together to discuss policy issues, requires a level of organisational capacity 
and resources that many NGOs lack. Associations are not funded for their core work as 
such, because the legal basis of the Public Health Programme 2003-2008 does not allow 
such direct funding. The Commission is therefore proposing operational grants as well as 
project  grants  to  provide  core  funding  to  certain  NGOs,  including  patient  groups,  in 
order to help them develop their organisational capacity and put themselves on a sound 
basis. 

As  underlined  in  the  Lisbon  process,  there  is  a  need  to  reduce  the  major  differences 
between  Member  States  in  terms  of  life  expectancy,  health  status  and  health  systems 
capability.  Following  enlargement,  supporting  in  particular  the  new  Member  States  to 
develop  their  health  systems  requires  additional  resources.  In  addition  to  infrastructure 
investment  and  human  resources  to  which  the  Community  Structural  Funds  can 
contribute, there is a need for the Community to help these countries in terms of training, 
expertise, capacity building, preparedness, prevention and promotion, as well as a need 
for analysis on their health investment needs.  

Finally,  ageing  of  the  EU  population  and  its  potential  impact  on  the  sustainability  of 
public  finances,  not  least  from  the  relative  decline  in  the  working  population,  requires 
EU action to help Member States cope with this challenge. 

Cost-effectiveness 

The adaptation of the existing Public Health Programme executive agency to support the 
new  proposed  programme  will  also  lead  to  savings  in  terms  of  input  as  regards  tasks 

88 

COM(2004) 301, COM(2004) 304, COM(2004) 356. 

EN 

47 

  EN 

 
 
 
 
 
 
 
 
 
 
                                                 
related  with  tendering  and  organisation  of  meetings.  The  outsourcing  of  such 
administrative tasks to the executive agency will also enable the Commission to focus on 
policy  making  and  conception  tasks,  including  developing  significant  links  with  other 
policies. 

The  programme  foresees  improving  the  way  projects  results  are  exploited  and 
disseminated,  which  will  increase  projects’  impact  and  visibility.  The  outsourcing  of 
administrative tasks will enable the Commission to focus on ensuring that health crises 
and  emergencies  are  better  handled,  that  project  results  are  better  disseminated,  to 
expand  work  with  stakeholders  and  to  develop  policy  work  on  e.g.  health  inequalities, 
ageing and children’s health. 

6.2.2. Measures  taken  following  an  intermediate/ex-post  evaluation  (lessons  learned  from 

similar experiences in the past) 

Ex post evaluation of the former 8 public health programmes 

The role of the European Community in the field of public health, as defined 
by  the  Treaty,  is  to  complement  Member  States’  action  by  promoting 
information  and  education,  encouraging 
research,  providing  health 
cooperation  and  fostering  policy  coordination  among  Member  States 
through incentive measures. An evaluation of the 8 Community programmes 
of  1996-2002  was  carried  out  in  200489.  The  main  objective  was  to  assess 
whether the goals were achieved in the EU through these action programmes 
and to locate the genuine added value of European intervention in the field 
of public health. 

The  evaluation  shows  that  the  Programmes  had  an  overall  positive  added 
value and calls for further investment by the EU in Public Health. It gives a 
number  of  recommendations  :  some  of  the  issues  raised  have already been 
addressed when building the Public health programme 2003-2008. However 
room for improvement remains for the following areas: 

– 

– 

– 

– 

develop  a  complete  and  coherent  theory  of  action  for  the  general 
public health framework; 

clarify  the  priorities  the  programme  seeks  to  meet  and  the  levels 
targeted; 

be  structured  and  research  synergies  and  complementarities  between 
the policy instruments and the research areas; 

in  the  area  of  health  determinants,  redirect  a  substantial  part  of  the 
new programme towards the aspects of these diseases which have not 
been fully researched and towards tackling the issue of diseases from a 
preventive point of view; 

89 

Deloitte  report  of  2004  :  “Final  Evaluation  of  the  eight  Community  Action  Programmes  on  Public  Health 
(1996-2002) – web link : http://europa.eu.int/comm/health/ph_programme/evaluation_en.htm. 

EN 

48 

  EN 

 
 
 
 
                                                 
– 

– 

– 

– 

– 

to  allow  more  room,  in  cases  regarding  the  share  of  responsibilities 
between the EU and the Member States, for a re-orientation of the EU 
priorities towards emerging issues and innovative approaches; 

to maximise the possibilities to exchange information and knowledge 
between  Member  States,  notably  to  allow  bridging  the  gap  between 
countries 
the  most  advanced  states,  specially 
considering the recent enlargement; 

lagging  behind 

to set up a systematic internal and external communication policy; 

to  enhance  training  activities,  as  it  is  the  most  valuable  way  of 
disseminating methods and best practices; 

to reserve financing in the new programme for the effective and large 
networks,  i.e.  which  are  representative  in  terms  of  partners  involved 
and coverage of the EU as a whole, so to ensure their sustainability. 

These  recommendations  will  be  reflected  as  far  as  possible  in  the 
construction of the new programme. 

6.2.3. Terms and frequency of future evaluation 

Details and frequency of planned evaluation: 

(See Article 13 of the proposed Programme) 

An  external  and  independent  interim  evaluation,  i.e.,  mid-term  report  will  be 
undertaken three years after adoption of the programme. The object of this report 
is  to  provide  an  initial  assessment  of  the  impact  and  effectiveness  of  the 
programme  on  the  basis  of  the  results  obtained.  The  report  shall  in  particular 
make it possible to assess the impact of measures on all countries. Any changes 
or adjustments that are deemed necessary will be proposed by the Commission for 
the second half of the programme.  

Communication  on  the  continuation  of  the  Programme  no  later  than  four  years 
after its adoption. 

Ex  post  evaluation,  i.e.  final  Report:  A  detailed  external  independent  evaluation 
report covering the entire period of operation of the Programme will be carried out 
by 31 December 2015, to assess the implementation of the Programme.  

Furthermore,  the  Commission  plans  to  audit  beneficiaries  in  order  to  check  that 
Community  funds  are  being  used  properly.  The  results  of  audits  will  form  the 
subject of a written report. 

Evaluation of the results obtained: 

Information  providing  a  measure  of  the  performance,  results  and  impact  of  the 
Programme will be taken from the following sources: 

– 

statistical  data  compiled  on  the  basis  of  the  information  from  application 
dossiers and the monitoring of beneficiaries' contracts; 

EN 

49 

  EN 

 
 
 
 
 
 
 
 
 
 
– 

– 

audit reports on a sample of programme beneficiaries ; 

use of the results of the executive agency’s evaluations and audits. 

7. 

Anti-fraud measures  

All the contracts, conventions and legal undertakings concluded between the Commission and 
the beneficiaries under the programme foresee the possibility of an audit at the premises of the 
beneficiary by the Commission’s services or by the Court of Auditors, as well as the possibility 
of requiring the beneficiaries to provide all relevant documents and data concerning expenses 
relating to such contracts, conventions or legal undertakings up to 5 years after the contractual 
period. Beneficiaries are subject to the requirement to provide reports and financial accounts, 
which are analysed as to the eligibility of the costs and the content, in line with the rules on 
Community financing and taking account of contractual obligations, economic principles and 
good financial management. 

EN 

50 

  EN 

 
8. 

DETAILS OF RESOURCES 
8.1.  Objectives of the proposal in terms of their financial cost 

Commitment appropriations in EUR million (to 3 decimal places) 

(Headings 
of 
Objectives,  actions 
and  outputs  should 
be provided) 

Type of output  Av. 
cost 

2007 

2008 

2009 

2010 

2011 

2012 

2013 and later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

total 
costs 

N 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

OPERATIONAL 
OBJECTIVE  No.1 
citizen's 
health 
security 

Action 1.1 : protect 
citizens 
against 
health threats 

Action 
improve 
safety 

1.2 
: 
citizen's 

Sub-total  Objective 
1 

OPERATIONAL 
OBJECTIVE  No.2 
: promote health 

 Projects, 
conferences, 
studies, 
meetings, 
networks 

 Projects, 
conferences, 
studies, 
meetings, 
networks 

Action  2.1  :  foster 
healthy, 
active 
ageing  and  help 
bridge inequalities  

projects, 
networks, 
conferences, 
meetings 

0,600 

13 

7,760 

15 

9,040 

16 

9,409 

15 

9,137 

16 

9,467 

17 

9,933 

17 

10,30
1 

108 

65,048 

0,600 

6 

3,880 

8 

4,520 

8 

4,705 

8 

4,569 

8 

4,734 

8 

4,966 

9 

5,151 

54 

32,524 

19 

11,640 

23 

13,561 

24 

14,114 

23 

13,70
6 

24 

14,201 

25 

14,899 

26 

15,45
2 

164 

97,572 

0,600 

8 

5,04 

10 

5,876 

10 

6,116 

10 

5,939 

10 

6,154 

11 

6,456 

11 

6,696 

70 

42,281 

EN 

51 

EN 

 
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
2.2 

Action 
: 
Promote  healthier 
life  by 
ways  of 
tackling 
health 
determinants  

projects, 
networks, 
conferences, 
meetings 

0,600 

14 

8,54 

17 

9,944 

17 

10,350 

17 

22 

13,58 

27 

15,821 

27 

16,466 

27 

10,05
1 

15,99
0 

17 

10,414 

18 

10,926 

19 

27 

16,568 

29 

17,382 

30 

11,33
2 

18,02
7 

119 

71,553 

189 

113,834 

Sub-total  Objective 
2 

OPERATIONAL 
OBJECTIVE  No.3 
generate 
and 
disseminate  health 
knowledge  

3.1: 

Action 
Exchange 
knowledge and best 
practice 

Action  3.2:  Collect, 
analyse 
and 
disseminate  health 
information 

Sub-total  Objective 
3 

TOTAL COST 

0,600 

10 

5,82 

11 

6,78 

12 

7,05 

11 

6,86 

12 

7,10 

12 

7,46 

13 

7,73 

81 

48,78 

0,600 

13 

7,76 

15 

9,04 

16 

9,40 

15 

9,14 

16 

9,46 

17 

9,94 

17 

10,30 

108 

65,04 

23 

64 

13,58 

26 

15,82 

28 

16,45 

26 

16,00 

28 

16,56 

29 

17,40 

30 

18,03 

190 

113,82 

38,80 

76 

45,20 

79 

47,00 

76 

45,70 

79 

47,30 

83 

49,70 

86 

51,50 

543 

325,20 

EN 

52 

EN 

 
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
8.2.  Administrative Expenditure 

8.2.1. Number and type of human resources 

Types of post 

Staff to be assigned to management of the action using existing 
and/or additional resources (number of posts/FTEs) 

Officials or temporary 
staff[1] (17 01 01) 

2007 

2008 

2009 

2010 

2011 

2012 

2013 

A*/AD 

22 

22 

22 

22 

22 

22 

22 

B*, 
C*/AST 

11 

11 

11 

11 

11 

11 

11 

Staff financed[2] by art. 17 01 02 

15 

15 

15 

15 

15 

15 

15 

Other staff [3] financed by art. 17 01 
04/05 

TOTAL 

48 

48 

48 

48 

48 

48 

48 

The calculation includes the existing resources devoted to the current programme, 
and  the  new  requested  staff,  subject  to  agreement  under  the  annual  procedure  of 
resources allocation (APS/PDB). The increase in the Commission staff is needed 
to.  undertake  the  conceptual  and  strategic  preparatory  work  during  the  first 
years  of  the  programme.This  increase  should  be  covered  within  the  pre-
allocation of the DG in the PDB for 2007. 

It does not include the executive agency’s staff. 

8.2.2. Description of tasks deriving from the action 

This is explained in the explanatory memorandum. 

8.2.3. Sources of human resources (statutory) 

(When  more  than  one  source  is  stated,  please  indicate  the  number  of  posts 
originating from each of the sources) 

X 

Posts  currently  allocated  to  the  management  of  the  programme  to  be 
replaced or extended 

X 

Posts pre-allocated within the APS/PDB exercise for year 2007 

(cid:133) 

(cid:133) 

Posts to be requested in the next APS/PDB procedure 

Posts to be redeployed using existing resources within the managing service 
(internal redeployment) 

EN 

53 

  EN 

 
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
(cid:133) 

Posts required for year n although not foreseen in the APS/PDB exercise 
of the year in question 

8.2.4. Other  Administrative  expenditure  included  in  reference  amount  (XX  01  04/05  – 

Expenditure on administrative management) 

Budget line 

(number and heading) 

1 Technical and 
administrative assistance 
(including related staff 
costs) 

Executive 

agencies[1] 

Other technical 

and administrative 
assistance 

- intra muros  

- extra muros 
Total Technical 

and administrative 
assistance 

2007 

2008 

2009 

2010 

2011 

EUR million (to 3 decimal places) 

2012 

2013 
and 
later 

TOTAL 

4,10 

4,10 

4,30 

4,30 

4,40 

4,50 

4,60 

30,30 

1,000 

0,200 

1,190 

0,210 

1,280 

0,221 

1,018 

0,382 

1,257 

0,243 

1,245 

0,255 

1,182 

0,418 

8,172 

1,928 

5,30 

5,50 

5,80 

5,70 

5,90 

6,00 

6,20 

40,40 

These  costs  include  the  programme’s  contribution  to  the  operating  costs  of  the  Public  Health 
Executive  agency,  and  notably  the  personnel  costs  to  the  agency  for  this  programme.  These  costs 
correspond to an estimation of 26 people (statutory personnel at the agency and contractual agents) 

8.2.5.  Financial cost of human resources and associated costs not included in the reference amount 

EUR million (to 3 decimal places) 

Type of human resources 

2007 

2008 

2009 

2010 

2011 

2012 

2013 
and 
later 

Officials and temporary staff (17 01 01) 

3,564
6 

3,564
6 

3,564
6 

3,564
6 

3,564
6 

3,564
6 

3,564
6 

Staff financed by Art 17 01 02 
(auxiliary, END, contract staff, etc.) 
(specify budget line) 

Total cost of Human Resources and 
associated costs (NOT in reference 
amount) 

1,62 

1,62 

1,62 

1,62 

1,62 

1,62 

1,62 

5,184 

5,184 

5,184 

5,184 

5,184 

5,184 

5,184 

Calculation – Officials and Temporary agents 

Calculation  includes  overheads  expenses  and  is  based  on  the  average  cost  in  the 
Commission 

EN 

54 

  EN 

 
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
Calculation– Staff financed under art. XX 01 02 

Calculation  includes  overheads  expenses  and  is  based  on  the  average  cost  in  the 
Commission 

8.2.6  Other administrative expenditure not included in reference amount 

2008 

2009 

2010 

2011 

2012 

2013 

TOTAL 

0,528 

0,530 

0,533 

0,536 

0,538 

0,541 

2,657 

EUR million (to 3 decimal places) 

1,407 
0,422 

1,414 
0,424 

1,421 
0,426 

1,428 
0,428 

1,435 
0,431 

1,443 
0,433 

17 01 02 11 

0,525 

0,528 

0,530 

0,533 

0,536 

0,538 

0,541 

2,870 

2,884 

2,899 

2,913 

2,928 

2,942 

2,957 

7,085 

2,125 

2,657 

14,524 

17 01 02 11 

01 – Missions 

2007 

0,525 

17 01 02 11 

1,400 

02 – Meetings & 
Conferences; 
Committees 

17 01 02 11 

0,420 

04 – Studies & 
consultations 

05 - Information 
systems 
 2 Total Other 
Management 
Expenditure (XX 01 
02 11) 

3 Other expenditure of 
an administrative 
nature (specify 
including reference to 
budget line) 
Total Administrative 
expenditure, other than 
human resources and 
associated costs (NOT 
included in reference 
amount) 

2,870 

2,884 

2,899 

2,913 

2,928 

2,942 

2,957 

14,524 

Calculation - Other administrative expenditure not included in reference amount 

The needs for human and administrative resources shall be covered within the 
allocation granted to the managing Directorate-General in the framework of the 
annual allocation procedure. 

EN 

55 

  EN