Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DECISION adopting a programme of Community action on health monitoring in the context of the framework for action in the field public health
Date: 1995-10-16
Institutions: European Commission
Subjects: EU action, exchange of information, health policy, international cooperation, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels,  16.10.1995 
COM(95)  449 final 

95/0238  (COD) 

COMMUNICATION  FROM  THE  COMMISSION 

concerning  a Community  action  programme  on 
health  monitoring  in  the  context 
of  the  framework  for  action  in 
the  field  of  public  health 

Proposal  for  a 

EUROPEAN  PARLIAMENT  AND  COUNCIL  DECISION 

adopting  a  programme  of  Community  action  on 
health  monitoring  in  the  context  of  the 
framework  for  action  in  the  field  of 
public  health 

(presented  by  the  Commission) 

TABLE OF CONTENTS 

I. 

II. 

INTRODUCTION 

A REVIEW OF EFFORTS ON EUROPEAN HEALTH DATA AND 
INDICATORS 

III. 

THE EUROPEAN COMMUNITY AND HEALTH MONITORING 

A.  A NEW ROLE FOR THE COMMUNITY 
B.  RECENT COMMUNITY  INITIATIVES 

IN HEALTH  INFORMATION 
C.  OTHER COMMUNITY  POLICIES 
AND AREAS OF ACTION 

IV. 

PURPOSE AND PRINCIPLES OF A  COMMUNITY 
HEALTH MONITORING SYSTEM 

V. 

COMMUNITY HEALTH  INDICATORS 

A.  CORE  INDICATORS 
B.  BACKGROUND  INDICATORS 
C.  ADDITIONAL  INDICATORS 
D.  A  HARMONISED  SYSTEM OF STATISTICS ON HEALTH 

RESOURCES 

VI. 

METHODOLOGY OF HEALTH DATA COLLECTION AT 

COMMUNITY LEVEL 

• 

VII. 

SERVING THE COMMUNITY HEALTH MONITORING  SYSTEM 

VIII. 

ANALYSES 

..* 

.• 

IX. 

PROPOSED ACTIONS FOR A  FIVE-YEAR PROGRAMME 
A.  ESTABLISHMENT OF COMMUNITY 

HEALTH  INDICATORS 

3 

5 

6 

6 

7 

.9 

12 

13 

14 
14 
15 

15 

15 

17 

18 

19 

19 

B.  DEVELOPMENT OF A COMMUNITY-WIDE NETWORK FOR DATA 

COLLECTION AND DISSEMINATION 

C .  ANALYSES 

'. 

X. 

CONSULTATION, ASSESSMENT, AND REPORTS  . . . 

A.  CONSULTATION AND PARTICIPATION MECHANISMS 
B.  EVALUATION REPORTS 
C.  GENERAL  INFORMATION ACTIVITIES 

ANNEX A 

2 0 
21 

21 

21 
2 2 
2 2 

23 

9? 

1. 

2. 

3. 

4. 

I. 

INTRODUCTION 

"'T 

By virtue of Articles 3(o) and  129 of the Treaty establishing the European  Community,  the 
Community  has for  the first  time been  given  an explicit  legal  basis for  undertaking  action 
in the field of  public  health.  The  role of the  Community  is to contribute towards  ensuring 
a high level of human health protection, directing actions towards the prevention of diseases, 
in particular by encouraging cooperation between Member States and, if necessary, lending 
support  to  their  action,  and  by  promoting  coordination  of  their  policies  and  programmes. 

In  its communication  of  24 November  19931  on the  framework  for  Community  action  in 
the field of  public  health,  the  Commission  defined  a framework  for  Community  action  in 
order to attain the objectives  on health  protection  laid down  in  Articles 3(o) and  129. The 
role  of  the  Community  is  identified  as underpinning  the  efforts  of  the  Member  States in 
the public  health  field,  assisting  in  the  formulation  and  implementation  of  objectives  and 
strategies,  and  contributing  to  the  provision  of  a  high-level  health  protection  across  the 
Community,  setting  as a target  the best  results  already  obtained  in  a given  area  anywhere 
in  the  Community. 

In  initiating  action  under  Article  129, the  Community  has  to  address  itself  to  preventing 
disease  and  protecting  health.  A prerequisite  for  such  action  is  knowledge  about  existing 
problems,  their  nature,  and  their  extent.  It  is  therefore  necessary  to  measure  the  changes 
in health  as well  as the  impact  of  policies,  programmes,  and  actions, both  in  the  Member 
States and  at the Community  level, in order to ascertain  that  actions attain their  objectives 
and  actually  lead  to  the  improvements  intended.  Appropriate  measures  to  monitor  health 
and its determinants,  as well  as a capacity  for  the monitoring  and  evaluation  of actions are 
therefore  needed.  Based  on  the  criteria  laid  down  in  the  above-mentioned  Commission 
communication,  health  data  and  indicators  have been  identified  as  essential  means  to  the 
acquisition  of  such  knowledge  and  capacity,  and,  therefore,  as  a  priority  for  Community 
action. 
Health  data  and  indicators  have  also  been  singled  out  by  the  Council",  the  European 
Parliament3, and the Economic and Social Committee4 as an important area for  Community 
action  in  public  health.  A  long  series  of  resolutions,  conclusions,  and  opinions  by  these 
institutions  culminated  in  June  1994  in  the  adoption  of  a  Council  resolution  on  the 
framework  for  future  action  in  the field of  public  health,  which  identified  health  data and 
indicators  as  an  area  to  which  priority  should  be  assigned  and  on  which  the  Commission 
was  invited  to  present  proposals5. 

COM  (93)  559 final 

OJ  No.  C  174,  25.6.1993,  p.l. 

OJ  No.  C  329,  6.12.1993,  p.  375 

6  May  1994,  ENVI/379 

OJ  No.  C  165,  17.6.1994,  p.l 

3 

5. 

The  efforts  of  the  Commission  in  this  area  concentrated  on  identifying  the  needs  of  tfîe 
Community  and the Member  States, and on determining how to obtain the maximum  effect 
from  the involvement of the Community while fully  respecting the principle of subsidiarity. 
To  this  end,  the  Commission  has,  with  the  assistance  of  Member  States'  representatives, 
conducted  a  review  of  existing  health  data  and  indicators.at  the  Community  level,  their 
sources,  coverage,  and  importance,  and  obtained  valuable  advice  and  recommendations. 

6. 

In  this  communication,  health  monitoring  covers  the  following  three  elements: 

collection  of  health  data  at  the  Community  level  and  development  of  Community 
health indicators. This includes the development of mechanisms for  Community  data 
collection,  including  surveys,  as well  as the  development  of  agreed  definitions  and 
methodologies  for  Community  health  indicators. 

building a capacity for analysis of data obtained from the monitoring of developments 
in  health,  disease,  other  health  problems,  and  health  determinants.  This  includes 
analysis of the distribution of diseases and disability  in human populations and of the 
factors  which  influence  that  distribution. 

dissemination of information  on health and its determinants to enable the Community 
as well  as the Member  States to establish  priorities, review policies and  actions, and 
assist  them  in  deciding  on  allocation  of  resources. 

7. 

8. 

Health  monitoring  is  not  meant  to  cover  disease  surveillance  for  control  purposes  which 
is undertaken with the aim of rapidly deciding on counter-measures  and actions to be taken 
by  the  competent  authorities  in  order  to  address  acute  health  problems  and  control  often 
rapidly  evolving  situations,  especially  in  the  area  of  communicable  diseases.  However, 
disease surveillance systems may provide appropriate input to an overall  health  monitoring 
system,  especially  as regards the  incidence  and  prevalence  of  specific  diseases. 

Health monitoring at the Community  level would cover the areas of public health  in which 
the  Commission  has  already  proposed  a number  of  action  programmes  covering  cancer6, 
health  promotion,  information,  education,  and training7,  drug  dependence',  and  AIDS  and 
certain other communicable diseases , and would  draw from  the results of pertinent  actions 
undertaken  under these programmes. Moreover,  Community  health monitoring should  also 
serve  to  assess  the  impact  on  health  of  Community  programmes  and  other  Community 
policies  and  also  provide  a  means  for  comparisons  between  Member  States  and  between 
the European  Community  and  other  parts  of  the  world. 

O J N oC  139, 21.5.1994,  p.  12 

O J N oC  252,  9.9.1994,  p. 3 

8 

O J N oC  257,  14.9.1994,  p. 4 

OJ  No  C  333, 29.11.1994  and  COM(94),  p. 413 

9. 

10. 

11. 

12. 

13. 

Whether  the  impact  of  the  actions  taken  at  the  Community  and  national  levels  caiTbë 
properly  monitored  and  evaluated  depends,  inter alia,  on the  pertinence  and  quality  of the 
indicators available. The aim of the action programme proposed  in this document  therefore 
is  to  develop  a  high-quality,  policy-oriented  health  monitoring  system  to  support  the 
Community  and Member  States in health  policy-making  and evaluation.  The starting point 
for  such  a  system  is,  of  course,  what  already  exists  in  Member  States,  and  what  is 
transmitted  by them  to international  organisations,  notably  the  World Health  Organization 
(WHO) and the Organization for Economic Cooperation  and Development (OECD). Based 
on this,  a careful  selection  has to be made of  indicators  covering  agreed  areas of  interest, 
supplemented  by  new  ones  as  appropriate,  and  a  system  developed  for  the  purpose  of 
underpinning  the  collection  of  data  and  making  them  available  to the Member  States  and 
the  Community. 

To  be  able  to  meet  expectations  in  this  area  and  yield  the  maximum  added  value,  a 
Community  health  monitoring  system would  have to consist not only  of carefully  selected 
Community  health  data  and  indicators  but  also  of  a  network  for  the  collection  and 
dissemination  of  Community  data,  mainly  using the possibilities  offered  by  telematics.  In 
addition,  an integral  part of such  a system will be the capacity to contribute to the analysis 
of  health  and  health-related  information,  to  respond  to  information  requests  and  test 
hypotheses,  and  to disseminate,  where appropriate,  the results  of these  analyses.  An  over 
riding consideration  in all of the work involved  is the respect of data protection  legislation 
implementation  of  appropriate  confidentiality  and  security 
requirements,  and 
arrangements. 

the 

II.  A  REVIEW  OF  EFFORTS  ON  EUROPEAN  HEALTH  DATA  AND 

INDICATORS 

The  search  for  objective  measures  of the health  status of  a population  has a long tradition 
in public health and may be traced back to the foundation  of demography  in the second half 
of the  17th  century.  For  more than  a century,  infant  mortality  and  life  expectancy  at birth 
have  been  widely  accepted  as valid  measures  of  the  level  of  health  in  a  population.  It  is 
only  a relatively  recent  development  that  a wider  range  of  indicators  has been  introduced 
to  complement  the picture,  coupled  with  epidemiological  research. 

This  development  has  been  brought  about,  inter  alia,  by  a  growing  awareness  within  the 
health  sector  that,  as  a  consequence  of  the  rapid  decline  in  previously  important  health 
scourges,  in  particular  infectious  diseases,  such  mortality-based  measures  could  no  longer 
be viewed  as sufficient,  and  by  the development  and  widespread  adoption  of  quantitative 
measurements  in  the  social  sciences  and  in  public  health. 

The growing use of indicators for the formulation,  implementation,  and evaluation of social 
policies and programmes has been promoted by the work of the United Nations, particularly 
its efforts,  since the  1950s, to develop a Level of Living Index and design a system of social 
accounts.  The  social  indicators  programme  of the  OECD  has  also  had  substantial  impact 
on the  establishment  of  indicators  in  OECD  countries. 

14. 

As to health indicators, which are usually  a constituent part of social  indicators, the League 
of Nations, already  in the  1930s, published  a comprehensive  review of  "indices of health". 

15. 

16. 

17. 

18. 

19. 

After the second world war, many initiatives on health indicators were undertaken, especially 
in  the United  States. 

Internationally, the systematic use of health indicators and policy-oriented health information 
has been  promoted  by  the WHO  since the  early  eighties.  In  its Health  For  All  strategy,  a 
significant  role  has  been  assigned  to the  monitoring  and  evaluation  of  regional,  national, 
and  global  health  strategies.  A  minimal  list  of  global  indicators  has  subsequently  been 
' introduced.  In  1984, the WHO's Regional  Office  for  Europe  has added  to this list  regional 
indicators tailored to the specific needs and priorities in Europe. Countries have been invited 
to use additional  national  indicators in keeping with their own needs and  capabilities10. On 
the basis  of  these  indicators,  WHO  regularly  undertakes  monitoring  exercises  in  order  to 
measure  progress  in  relation  to the Health  For  All  targets  and  to. assess  its  priorities. 

The  OECD  has  also carried  out valuable  work  on  health  indicators,  especially  in  relation 
to  indicators  on the provision  of health  care.  This work  is to  some  extent  complementary 
to the work of WHO. Finally, a number of specialised European  institutions and networks, 
like  the  International  Agency  of  Research  on  Cancer  (IARC)  in  Lyon  and  the  European 
Centre  for  the  Epidemiological  Monitoring  of  AIDS  in  Paris,  have  contributed  to  the 
production  of  valuable  health  information  at  the  European  level,  with  support  from  the 
Community, particularly in relation to relevant programmes and actions in the field of public 
health. 

In the first Biomedical  and Health research programme (1990-1994), within the third  RTD 
framework programme, research on health systems allowed the setting up of specific disease-
related  databases  and  valuable  European  networks  for  health  data  exchange. 

The  Statistical  Office  of the European  Communities (Eurostat) has also collected  statistical 
data  on  health  and  health-related  issues for  a number  of  years.  In  particular,  a number  of 
health  indicators  have been  selected  as  part  of  the  global  framework  for  social  indicators 
and  social  statistics. 

Significant  international  experience  has  already  been  gathered  in  the  field  of  health 
information  and  the  use  of  health  indicators.  The  Community  has  played  a  role  in  this 
process, but its involvement needs to be stepped up if an appropriate contribution to ensuring 
a high-level  of  health  protection  is to be  made. 

III.  THE  EUROPEAN  COMMUNITY  AND  HEALTH  MONITORING 

A.  A  NEW  ROLE  FOR  THE  COMMUNITY 

20. 

Member  States  are  becoming  more  closely  interdependent  in  many  areas.  In  the  area  of 
economic  integration,  this takes  place  at  a fast  pace,  but  also  in  other  areas,  such  as  free 
circulation,  the environment,  professional  education  and  research  and  social  provisions, in 
particular  health  and  safety  at  work,  common  approaches  to  existing  problems  are 

10 

HANSLUWKA,  H E,  "Measuring  health  of  populations-Indicators  and 
Indications,"  Social  Sciences and Medicine,  1985,  Vol.  20,  No.  12, pp.  1207-1224. 

21. 

22. 

23. 

24. 

25. 

increasingly being sought and implemented. The impact of the Community is, in this respect, 
preponderant. 

Health  is no exception  to this. Not  only  do health  problems  cross borders, but they  appear 
to be growing  more alike in  each  country.  Moreover,  European  cooperation  on health  has 
made important  strides and attempts are increasingly being made to find common  solutions 
and to step up the exchange of expertise and the sharing of experience.  As a result  of such 
internationalisation,  interest  in  other  countries'  problems  and  policies  has  grown  and 
international comparisons are becoming an important tool in national and Community health 
policy-making.  The Member  States of the European  Community  have over the last  decade 
steadily increased their cooperation in the public health field to cover a wide range of areas, 
and  the  Community  has  played  an  increasingly  important  role  in  this  process,  especially 
after  the  coming  into  force  of  the  Treaty  on  the European  Union. 

Community  actions  implementing  Article  129  of  the  Treaty  establishing  the  European 
Community  must  have  as  objective  to  make  a contribution  towards  ensuring  a high  level 
of human  health  protection,  focus  on  the  prevention  of  diseases,  promote  coordination  of 
Member  States'  policies  and  programmes  and  foster  cooperation  with  third  countries  and 
international  organisations competent in the sphere of public health. The elaboration of such 
actions in a way that maximises the Community's contribution,  and the assessment  of these 
actions  to  determine  whether  they  have  accomplished  their  objectives,  presupposes  the 
existence  of  quantitative  measures  and  of  a system  which  permits  the measurement  of  the 
changes  in  health  and  its determinants,  and  the impact  on health  of  policies,  programmes, 
and  actions  at  the  level  of  Member  States  as well  as the  Community. 

B.  RECENT  COMMUNITY  INITIATIVES  IN  HEALTH  INFORMATION 

In  a  number  of  documents,  in  particular  in  the  Report  on  Public  Health  Policy  after 
Maastricht11,  the European  Parliament  has stressed the importance  of having  sufficient  and 
relevant  information  as a basis  for  the development  of  Community  actions  in the  field  of 
public  health. 

In the resolution adopted with the report, the European Parliament called on the Commission 
to establish a European epidemiological  investigation unit to collect and examine health data 
from  Member  States  and  to  begin  work  on  a  "State  of  Health  in  the  Community"  report 
which  will  analyse  trends  and  assess  the  effects  of  public  health  policies,  as  well  as  the 
impact of other policies on health. Moreover, it requested the Commission to collect, analyse 
•and  disseminate  Member  State  data  on  notifiable  diseases  and  to work  with  national  and 
international  agencies  in  these  matters. 

The Commission,  in its Communication  of 24 November  1993 on the framework  for  action 
in  the  field  of  public  health,  identified  increased  cooperation  on  standardisation  and 
collection  of  comparable  data  on  health,  and  the promotion  of  systems  of  monitoring  and 
surveillance, as a prerequisite for the establishment of a framework  for supporting and adding 
value to Member States' policies and programmes, in compliance with the principle of subsidiarity. 

il 

OJNo.  C329,  6.12 93,  p.375 

26. 

27. 

In  its  resolution  of  2  June  1994  on  the  framework  for  Community  action  in  the  field  of 
public health, the Council  stressed the importance of the development of Community health 
information  and  indicated  that  data  and  indicators  used  should  include  measures  relating 
to  the  quality  of  life  of the  population,  accurate  assessments  of  health  needs,  estimations 
of  the  avoidable deaths  frorn  the prevention  of  diseases,  socio-economic  factors  on  health 
among different  population groups, and, where appropriate and if the Member  States judge 
it  necessary,  health  aid,  medical  practices,  and  the  impact  of  reforms. 

In December  1993, the High-Level  Committee  on Health,  which  advises the  Commission 
on  health  matters  and  comprises  senior  representatives  of  the  Health  Ministries  of  the 
Member  States,  set  up  a  working  party  on  health  data  and  indicators  to  assist  in  the 
development  of  a  Community  health  monitoring  system.  The  working  party  was  charged 
with  the  following  tasks: 

to  assess  the validity  and  comparability  of  health  data  available  in  the  Community. 

to assess the feasibility  of uniform  basic data sets for the purpose of monitoring health 
status  and  formulating  and  measuring  the  impact  of  prevention  policies. 

to examine the conversion  of  existing  health data  into effective  health  indicators  for 
specific  measures. 

to  define  possible  actions  for  further  co-operation  at  Community  level  in  this field. 

28. 

On  the basis  of  the report  of  the Working  Party,  which  included  a comprehensive  review 
of  definitions  and  sources  of  the  available  indicators  at  the  European  level  collected  by 
Eurostat,  WHO,  and  OECD, 
the  High  Level  Committee  adopted  a  number  of 
recommendations,  the  main  elements  of  which  are  as  follows: 

sets  of  Community  core  and  background  indicators  are  necessary  as  instruments  at 
Community  level  as well  as for  national  health  policy-making; 

the  available  health  data  are  very  diverse  as  far  as  comparability  and  validity  are 
concerned; 

with the necessary resources becoming available, substantial  progress can be achieved 
within  a  5-to-10-year period  on making  uniform  basic  data  sets  at Community  level 
to  measure  health  status  and  the  impact  of  public  health  policies; 

in  some  areas the  available  data  can  be  converted  into usable  specific  indicators.  In 
other areas, however, data do not exist or are inadequate to establish specific  indicators 
of  an  acceptable  quality. 

29. 

The  report  of ihe  Working  Party  and  the  recommendations  of  the  High  Level  Committee 
have  been  used  extensively  in  the  preparation  of  the  present  communication  and  the 
Commission  proposals  in  the  field  of  health  monitoring. 

30. 

31. 

32 

33 

34. 

C.  OTHER  COMMUNITY  POLICIES  AND  AREAS  OF  ACTION 

Community policies and actions in areas outside public health often  have direct and  indirect 
health  impacts.  In  its  report  on  the  integration  of  health  protection  requirements  in 
Community  policies  , the Commission  presented  an overview of programmes,  actions and 
instruments  having  an  impact  on  health. 

In the area  of  social  policy,  health  information  is mainly  linked to questions relative to the 
follow-up  of Member  States's policies regarding social protection,  particularly  with  respect 
to the  risk  of  illness.  In  its recommendation  3 on  convergence  of  social  policies  aiming  at 
guiding  the  policies  of  the  Member  States,  the  Council  set,  inter  alia,  the  following 
objectives: 

to ensure that people  legally  residing in the Member  States have  access to necessary 
health  care  as well  as to  measures  aimed  at  disease  prevention; 

to  maintain,  and  if  necessary,  develop  a  health  care  system  that  is  adapted  to  the 
changing  needs  of  the  population. 

The  Commission  closely  follows  the  developments  in  this  area  and  analyzes  and  reports 
on  the  convergence  or  divergence  of  social  policies.  Regarding  health  systems,  the 
monitoring  of  measures  taken  to try to keep  costs reasonable  and  to evaluate  performance 
also  requires  the  evaluation  of 
the  consequences  that  they  may  have  on  the  quality  of 
services  provided  and  the  equality  of  access  to care. 

In the area of health and safety  at work, sustained efforts  have been made at the Community 
level  to  obtain  harmonised  data  concerning  occupational  diseases  (EODS)  and  accidents 
at  work  (ESAW).  The  process  which  was  followed  involved  the  development  of  similar 
criteria  and  methodology  for  recording  statistics in  all Member  States. When these are put 
into  effect,  they  are  expected  to  produce  a  more  accurate  picture  of  the  extent  of 
occupational  diseases  and  injuries. 

Within  the  statistical  framework  programme  1993-1997,  laid  down  by  the  Council  in  its 
decision 93/464/EEC14, Eurostat produces statistical  data in areas, such as health and  safety, 
employment,  living  conditions  and  social  protection,  as fields of priority  action  under  the 
sectoral  programmes  for  social  policy,  for  economic  and  social  cohesion  and  consumer 
protection.  Community  statistics in areas such as environment,  industry,  national  accounts 
and  transport  are  also  collected  under  the  statistical  framework  programme.  In  addition, 
Eurostat collects data on certain other social indicators which are of interest to public health. 
In  1994, a Community  Household Panel  Survey (ECHP) was launched,  covering, inter alia, 

1 

r- 

1,1 

COM(95)  196,  29.5.1995 

Council  Recommendation  92/442/EEC,  OJ  No  L 245,  26.8.1992,  p.  49 

OJ  No.  L  219,  28.8.1993,  p.l 

9 

35. 

36. 

demographics,  income,  labour  force  participation,  education,  housing,  and  certain  health 
aspects. 

In the area of Trans-European  networks, the Commission  proposal  for  a Council  Decision 
on support for the telematic interchange of data between administrations in the Community 
(IDA)15 foresees  three projects  in  the  field  of  health,  namely  CARE  (two  projects  : early 
warning system  and pharmacovigilance) and REITOX (European  Information  Network on 
Drugs and Drug Addiction which will link with the European Monitoring  Centre for  Drugs 
and Drug Addiction). The two CARE projects retained in IDA are spin-offs  of earlier  efforts 
on  the  European  Nervous  System  (ENS-CARE).  Under  current  IDA  plans,  CARE-Early 
warning system (CARE-EWS) work and the work on a pharmacovigilance network, to which 
the European  Medicines  Evaluation  Agency  will  be linked,  will  concentrate  over the  next 
two years on further  development of the pilot systems between national  administrations and 
the passage to exploitation  phase, while strictly  adhering to the general  system  architecture 
foreseen  for  IDA. 

In  the  area  of  research  and  technological  development,  activities  under  the  third  RTD 
framework  programme included  research  on quality  of  care, avoidable  deaths  (deaths  that 
could  be  avoided  by  prevention),  a  European  stroke  database  (EUROSTROKE), 
harmonisation  of health  expectancy  calculations in Europe, comparison  and  harmonisation 
of  denominator  data  for  primary  health  care  research  in  Member  States  of  the  European 
Community',  and  the  establishment  of  a  European  Clearing  House  on  Health  Outcomes. 
Concerning  equality  of  access to care  according  to the level  of  income,  research  has been 
carried  out  on  comparing  health  care  consumption  and  morbidity  for  certain  groups  of 
individuals (the COMAC Project), the future  development  of which w?ould benefit  from  the 
existence,  at  the  Community  level,  of  indicators  on the  relationship  between  income  and 
morbidity. Under Area 6 of the Biomedical  and Health research programme1  (BIOMED  2) 
within  the 4th RTD framework  programme,  research  will  focus  initially  on  methodologies 
linked  to health  data  on demographic  changes,  methods  of  evaluating  the  effectiveness  of 
prevention  strategies,  and  assessment  of  the  socio-economic  impact  and  performance 
measurement  of  health  policy  initiatives  including  the  development  of  health  information 
systems. Finally, under the fourth RTD framework programme, activities initiated previously 
on  health  telematics  (ENS-CARE),  which  involved  pilot  projects  on  electronic  exchange 
of  health  data  concerning  communicable  diseases,  statistics,  poison  control  and 
pharmacovigilance,  are to be  pursued  in  certain  selected  areas. 

37. 

The environment plays an important role in the health of citizens.  Appropriate and  accurate 
information  on  the  state  of  the  environment  and  on  emissions  and  waste  disposal  into  its 
compartments is indispensible.  There is a need, in particular,  for  data on the  concentration 
of pollutants in the environment in order to estimate the impact of such pollutants on public 
health.  Examples  of  such  data  include  data  on  air  quality  in  urban  and  rural  areas  and  on 
concentration  of dangerous  substances in the soil  and ground  water,  in  particular  from  the 

OJ  N oC  105,  16.4.1993 

ib 

Council  Decision  94/913/EEC  of  15 December  1994,  OJ  No  L  361  of  31.12.1994, 
p.  40 

10 

38. 

39. 

40. 

use of  pesticides.  Moreover,  data  on the  effects  on  humans  from  the  incorporation  of 
pollutants,  and  on  the  pathways  for  such  incorporation  are  required  if  sound 
interventions  are  to  be  made.  The  European  Environment  Agency  has,  in  its  5-year 
Work Programme,  a project  on "Threats to Human Health" which  involves an analysis 
of the  current  situation  and  information/data  bank  linking  with  the  WHO. 

In  the  area  of  transport,  the  need  for  information  is  firstly  linked  to  the  problem  of 
achieving accessible public transport for everybody, which requires in turn  information 
on  the  patterns  and  geographical  distribution  of  various  types  of  disability,  mobility-
restricting illnesses, and age-specific  health factors,  and secondly to road accidents, for 
which  the  Council  decided  to  establish  a  Community  database1,  the  development  of 
which  will  serve  as  a basis  for  the  improvement  of  information  at  Community  level 
in  this  field. 

As  regards  consumer  protection,  efforts  to  organise  and  coordinate  the  collection  of 
data  on  home  and  leisure  accidents  is being  pursued  in  the  context  of  the  programme 
EHLASS2. 

The  Commission  has  also  recognised  the  importance  of  a  level  playing  field  of  data 
protection  rules  as  being  a  necessary  pre-requisite  to  the  free  exchange  of  data.  In 
1990,  it  proposed  a framework  directive  on  the  protection  of  individuals  with  regard 
to the processing  personal  data,  with  the aim  of  ensuring  the free  morvement  of  such 
data.  This  directive,  which  includes  specific  provisions  on  health  data,  has  been 
adopted  on  24.7.95  by  the  Council  and  the  Parliament.  The  Commission  has  also 
committed  itself to applying the principles of this directive to its own  data processing. 

41.  With regard to the Community  Agricultural  Policy, three information  systems (ADNS, 
ANIMO  and  SHIFT)  are  being  developed  using  telematics  as  essential  tools  in  the 
Community  veterinary  control  strategy. 

42. 

Finally,  in  the  area  of  drugs,  the  European  Monitoring  Centre  for  Drugs  and  Drug 
Addiction (EMCDDA) has as its main task to furnish  "overall information...on the drug 
and drug  addiction  phenomenon".  This will  involve providing  the  Community  and  its 
Member  States with  "objective, reliable and comparable information  at [the] European 
level concerning drugs and drug addiction and their consequences". Moreover,  through 
the European  information  network  on  drugs  and  drug  addiction  (REITOX)  data  will 
be collected  which  will  be used,  inter  alia,  in the preparation  of  a yearly  report  on the 
state  of  the  drugs  problem. 

OJ  No  L 329  of  30.12.93, p.63 

OJ  No.  L  331  of  21.12.94 

IV.  THE  PURPOSES  AND  PRINCIPLES  OF  A  COMMUNITY-WIDE  HEALTH 

MONITORING  SYSTEM 

43. 

Health information  has been identified  in Article  129 as a specific  area of action; moreover, 
as explained  above,  it has been  recognised,  in the form  of  health  data  and  indicators,  as a 
fundamental  instrument  in the Community  policy-making  process,  and  an essential  part of 
a  health  monitoring  system  which  will  be  required  to  serve the  following  purposes: 

to  monitor  health  and  health  determinants  throughout  the  Community,  and  permit 
comparisons  with  third  countries; 

to  facilitate  planning,  monitoring,  implementation,  and  evaluation  of  Community 
programmes  and  actions; 

to provide Member  States with  high quality,  comparative  indicators and  information 
which support and add value to their national health monitoring systems and contribute 
to the  development  of  national  health  policies. 

44. 

The development of a health monitoring system should be based on the following principles: 

the  system  should  build  on  readily  available  European  data  and  indicators,  such  as 
those  held  by  Member  States,  international  organisations,  notably  the  WHO,  the 
OECD, the EMCDDA  and the European  Environment  Agency,  European  networks, 
and  the  Commission.  In  a  first  stage,  these  data will  be used  for  heafth  monitoring 
and  policy  appraisal  purposes  and  should  also  serve  as  a  basis  for  identifying  the 
inevitable gaps in quality  and ways to overcome them,  as well  as for  developing new 
data  and  indicators  that  are  considered  necessary. 

any  unnecessary  duplication  of  work  should  be  avoided.  The  work  already  being 
carried  out  by  international  organisations,  European  networks,  and  the  Commission 
should  be  mutually  complementary  and  congruent.  On  the  one  hand,  existing  work 
of relevance to the Community  being carried  out by Member  States and the relevant 
international  organisations should be consolidated and progressively harmonised, thus 
minimising the risk of wasteful  overlap and competing demands on scarce resources. 
On the other  hand, the health  monitoring  system  should  as a matter  of priority  cover 
areas of  importance to Community  programmes  and  policies which  are not yet  fully 
developed  or  are  developed  insufficiently. 

the  system  should  not impose unnecessary  burdens on Member  States which  already 
transmit  health  data  to  a  number  of  international  organisations,  networks,  and  the 
Commission.  Serving  the  needs  of  a  Community  health  monitoring  system  should 
therefore not imply Member  States having to duplicate work carried out in the context 
of  existing  international  arrangements. 

available  options  and  possibilities  for  developing  the  various  parts  of  the  system 
whether  with  respect  to  the  choice  of  health  indicators,  the  extent  and  quality  of 
coverage, the means used, and the routine or ad hoc analyses to be undertaken,  should 
be  carefully  assessed  with  respect  to the  costs  and  benefits  involved; 

12 

45. 

46. 

47. 

48. 

the  system  should  be  designed  to  have  as  much  flexibility  as  possible  so  as  to  be 
capable  of  incorporating  existing  useful  elements  and  of  adapting  to  changes  in 
coverage  as  well  as  to  changes  in  the  priorities  for  action,  whilst  maintaining  its 
characteristics of comparability and progressive harmonisation. Furthermore, it is also 
important that the collection and distribution mechanisms for health data and indicators 
are  equally  flexible  and  do not  demand  undue  administrative  burdens. 

In establishing  a Community  health monitoring  system, it is important  to ensure that 
the  information  which  should  be  collected  and  disseminated  is  specified  in  close 
collaboration  with  the  potential  users  and  suppliers  in  Member  States  and  at  the 
Community  level,  and  that  data  protection  requirements  are  fully  respected. 

V.  COMMUNITY  HEALTH  INDICATORS 

On the basis of the needs of the proposed and planned  programmes and actions in the field 
of  public  health,  requirements  stemming  from  other  Commission  policies,  the  needs  of 
Member  States,  and  the  expected  developments  in  health  status  and  determinants,  the 
Commission  has  selected  a  number  of  domains  in  which  indicators  would  have  to  be 
established  as part  of the  Community  health  monitoring  system.  These  domains  are  listed 
in Annex  A.  It is important  to note that  data are already  being  collected  in these  domains 
but they have to be carefully  assessed with a view to establishing relevant health indicators. 

Community  health  indicators  would  consist  of  two  types:  core indicators  and  background 
indicators.  Core  indicators  are  considered  to  be  those  which  are  essential  to  Community 
public  health  programme  actions,  and  to  measuring  health  status  as  well  as  health 
determinants, e.g., alcohol and tobacco consumption. Background indicators are those linked 
indirectly  to public health but which are nevertheless important  for  health policy  purposes. 
They  include  indicators  which  concern  other  Community  policies.  They  also  include 
indicators  which  may  be  of  particular  use  to  Member  States  but  are  not  essential  for 
Community  policy  purposes. 

The indicators, both  core and background,  to be used in the Community  health  monitoring 
system will  be selected  from  those existing at the international  level  and  already  reviewed 
by  the High-Level  Committee  on Health,  and  those  existing  at national  level  but  deemed 
appropriate for  Community  use; moreover,  new ones will  have to be created,  if  necessary. 
This  process  will  be carried  out  in  close coordination  with  the Member  States  and,  where 
appropriate,  with  the  cooperation  of  international  organisations  competent  in  this  area. 
Community indicators would have to be continually evaluated and updated in order to ensure 
that they  fulfil  the current  needs of the Community  and  Member  States.  This may  involve 
developing new indicators and/or reclassifying  indicators from  background to core, and vice 
versa. 

49. 

Community  indicators  would  consist  of: 

indicators that provide both the Community and the Member States with an instrument 
for  making  comparisons  between  Member  States  and  also facilitate  coordination  by 
and  among  the  Member  States themselves; 

13 

indicators  that  facilitate  the  measurement  of  health  status  and  major  heàltlî 
determinants  in the  Community,  including  outcomes  and  use  of  resources. 

50. 

Depending  on  the  quality  and  availability  of  data  needed,  Community  indicators  will  fall 
into the  following  categories: 

those  for  which  good  quality  data  are  readily  available  in  all  Member  States; 

those for which d^ta are available in all Member States but for which the quality needs 
to  be  improved; 

those  for  which  data are not  currently  available  in  the Community  but which  would 
have  to be  collected  under  the  Community  programme  on  health  monitoring. 

A.  CORE  INDICATORS 

51. 

To  support  Community  action  in  the  field  of  public  health  a  core  set  of  basic  indicators 
should  be  developed.  These  indicators  would  represent  the  basic  information  needed  to 
monitor  health  status in the Community  and would  also reflect: key  public health  priorities 
as  defined  in the  Commission  communication  on the  framework  for  action  in the  field  of 
public  health1.  Over  time, these  indicators  could  be  adapted  to  reflect  changing  priorities. 

52. 

Consequently, the core indicators would be divided into the following two inter-related types: 

indicators for measuring health  status and determinants of health in the Community; 

indicators  for  measuring  the  impact  of  Community  policies  and  actions  in  public 
health. 

B. 

BACKGROUND  INDICATORS 

53. 

Since  priorities  change  over  time,  the  health  monitoring  system  should  be  sufficiently 
comprehensive  and  flexible  to respond  to  shifting  demands  arising  from  emerging  issues. 
As  a  means  of  obtaining  the  desired  coverage  and  flexibility,  a  number  of  indicators,  in 
addition  to  the  core ones,  should  be established  as background  indicators.  Such  indicators 
are  intended  to  provide  both  more  in-depth  information  in  the  areas  covered  by  the  core 
indicators  and  to  cover  a wider  range  of  areas. 

54. 

The  set  of  background  indicators  would  include  the  following  four  types  of  indicators: 

indicators that provide additional  information  on issues raised  by the core indicators, 
including the assessment of relations between health outcomes and health determinants; 

indicators  that  provide  information  regarding  other  Community  policies; 

indicators  that  support  public  health  policies  in  Member  States; 

55. 

56. 

57. 

58. 

indicators  that  provide  Member  States  with  information  for  making  comparisons  in 
areas  not  covered  by  the  core  set  of  indicators. 

C.  ADDITIONAL  INDICATORS 

In  areas  where  health  data  are  of  use  only  to  national  and/or  regional  authorities, 
coordination  of  definitions  and  collection  methods  will  have  to  be  promoted  in  order  to 
achieve  a higher  degree  of  comparability  between  regions  and  Member  States. 

D.  A HARMONISED SYSTEM OF STATISTICS ON HEALTH RESOURCES 

In  the  light  of  the  recommendations  of  the  High-Level  Committee  on  Health,  which 
emphasised  the  assessment  of  the  feasibility  and  cost-effectiveness  of  developing 
standardised  health  resource  statistics,  the  Commission  intends  to  give  support  to  efforts 
aiming  at incorporating  such  statistics into  a future  Community  health  monitoring  system. 
This would  provide an important  input to the work  currently  being done at European  level 
on  the  development  of  satellite  national  accounts  for  health. 

VI.  METHODOLOGY  OF  HEALTH  DATA  COLLECTION  AT  COMMUNITY 

LEVEL 

In developing a Community  health monitoring  system, a methodology  needs to be  followed 
to  ensure  that  the  data  obtained  from  the  Member  States  are  comparable,  i.e.,  defined  in 
the  same  manner  and  of  similar  (good)  quality.  In  addition,  the  data  must  also be  timely 
or they will  lose much of their usefulness.  Finally, the methodology  employed must  follow 
the principles set out in Chapter  IV for the establishment  of a Community health monitoring 
system. 

Avoiding  unnecessary  duplication  of  Member  States'  data  collection  efforts  points  in 
particular to the need of building on existing national databases validated by Member States' 
authorities.  Data held  in these databases  may  have to be supplemented  by  specific  surveys 
in order to collect  data that are not available by other means or that are needed  for  specific 
analyses.  Such  a  two-tier  approach  holds  the  promise  of  fast  and  cost-effective 
implementation.  In  addition,  this approach  ensures the maximum  use of existing  data  and 
allows Member  States to obtain improvements in the comparability and quality of their data. 
This  approach  creates,  however,  a  number  of  methodological  questions  which  must  be 
addressed. 

59. 

In particular, the comparability of existing data from Member  States is currently inadequate, 
because Member  States often  define  their  health  data and  indicators  differently.  However, 
comparability  may  be  improved  in  three ways: 

creating data dictionaries which could serve to establish correspondences between data 
defined  in  different  ways; 

converting national  data to Community network definitions  according to a commonly 
agreed  set  of  rules; 

15 

60. 

61. 

62. 

63. 

64 

65. 

harmonising  the definition  and  collection  methods of the  health  data  collected  in the 
Member  States. 

: 

Data dictionaries serve to explain how different Member States define similar concepts. Thus, 
they  provide  a way  to  establish  correspondences  between  data  while  retaining  individual 
definitions.  This  approach  is  likely  to  be  used  when  it  is  impossible  to  either  convert  or 
harmonise existing data.  In addition,  this method  may  also be employed  while  conversion 
and/or  harmonisation  methods  are being  developed. 

Comparability  may  also  be  improved  by  devising  and  agreeing  Community  network 
definitions enabling Member States to convert their data accordingly. Thisapproach improves 
comparability  of data at Community  level  without  requiring  Member  States to change  the 
definitions  they  use  for  their  internal  purposes. 

Harmonisation  of national  data definition  and  routine  collection  has the greatest  potential 
for  improving the comparability  and quality  of  Community  data..  However,  in  some cases 
harmonisation  may  require  changes  in  statutory  stipulations  or  long-established  traditions 
and  practices.  For  this  reason,  harmonisation  is  both  a  difficult  and  time-  and  resource 
consuming  process  and  should  therefore  be  carefully  evaluated  in  each  case to  assess  the 
costs and benefits involved. While harmonisation of existing data may be seen as a long-term 
goal,  and  is being  pursued  in  several  areas as mentioned  in  paragraphs  30 to  35, the  need 
for progress to be made on developing the Community health monitoring system means that 
recourse  should  be  made,  in  the  short-term,  to  both  data  dictionaries  and  conversion 
processes. 

Member States also collect health data through surveys, such as data on self-perceived  health 
status  which  must  be  obtained  directly  from  the  population,  or  particular  types  of  health 
care provider  data.  The  advantages  of the  survey  method  are that  data  are collected  at the 
same point in time and that it allows the establishment of interrelations between the  different 
variables.  Survey  data could be made comparable by  agreeing  on the content of present  or 
future  health  surveys  or  by  agreeing  modules  or  agreed  forms  of  words  for  questions  in 
existing surveys. Harmonisation  in the case of surveys is likely to be less time- and resource 
consuming,  in  part  because  it  is  easier  to  harmonise  survey  questions/instruments  and 
methodologies  than  elements  in  existing  registries  and  national  databases,  which  are 
sometimes  linked  to  statutory  requirements,  and  in  part  because  work  has  already  been 
initiated  in  this  area. 

In certain  areas, survey information  would have to be obtained  from  Member  States which 
do not currently  conduct health  surveys. This could be done by  developing  supplements to 
other types of national  surveys (e.g., labour force  surveys, household  surveys), which  take 
account of the need for comparable data throughout the Community, or through Community-
wide  surveys,  including  EUROBAROMETER  surveys. 

In addition  to the health  information  which  can be obtained  from  Member  States'  sources, 
as described  above,  specific  health  information  may  be needed  to address the needs of the 
Community  which  might  require  the  conduct  of  specific  Community-wide  surveys. 

16 

66. 

67. 

68. 

69 

In addition  to  determining  the  data  collection  method,  the  frequency  with  which  the  data 
must  be  collected  must  also  be  decided.  Data  needed  for  the  core  indicators  should  be 
collected  on  a  regular  basis  (annually  for  most)  and  processed  and  transmitted  rapidly  in 
order  to  ensure  the  availability  of  the  most  recent  data  possible.  Data  needed  for  the 
background  indicators,  however,  will  be  collected  at  such  intervals  as  are  necessary, 
depending  on  the  nature  of  the  indicator  and  the usage  to which  it will  be  put. 

VII. 

SERVING  THE  COMMUNITY  HEALTH  MONITORING  SYSTEM 

As stated  previously,  European  health  data are currently  collected  by the WHO  (causes of 
death),  the  WHO  Regional  Office  for  Europe  in  its  Health  for  All  database,  the  OECD 
(health  resource  data)  and  by  Eurostat.  Moreover,  data  on  specific  scourges  are  collected 
by  centres  like  IARC  in  Lyon  for  cancer,  the  European  Centre  for  the  Epidemiological 
Monitoring  of AIDS  in Paris,  and the EMCDDA  in Lisbon  for  drugs and  drug  addiction.. 
In  view  of  this,  and  in  order  not  to  impose  unnecessary  burdens  on  Member  States,  the 
Commission  will take into account the work carried out for,  and by, the various European-
level operators in the domain of the production, processing, and dissemination of Community 
data,  so  as  to  obtain  a judicious  division  of  labour  between  the  various  servers  of  the 
Community  health  monitoring  system. 

In  any  case,  a  Community  health  monitoring  system  has to  rely  primarily  on  health  data 
from  Member  States. At the same time, the system would have to be served by an  efficient 
and  cost-effective  means  for  the  transmission,  sharing,  and  dissemination  of  Community 
health  data. 

There  are various  means to  achieve  availability  and transfer  of  health  data  and  indicators. 
To ensure,  however,  that the role of the constituent  parts  of the future  Community  system 
is preserved  and  played  to full  advantage  as regards the means  of processing,  storage,  and 
rapid  transmission  of data, these  are best accomplished  by means of an electronic  network 
of distributed,  or disseminated,  databases. In such a network,  data would be made available 
by independent  data producers (i.e., national  administrations  and/or institutions under  their 
auspices)  in  accordance with  a set  of commonly  agreed  rules  covering  data  specifications. 

70. 

A network  of  distributed  databases  has  a number  of  advantages: 

it  is  future-oriented,  flexible,  and  less  costly  compared  to  traditional  collection 
methods; 

it  reduces  current  duplication  of  data  collection  efforts  at  the  international  level; 

Member  States  only  have  to  supply  data  once  (i.e.,  to  the  network); 

it  does  not  require  a major  new  administrative  structure; 

Member  States will be responsible for  entering the data into the system. The data can 
therefore  be  updated  continually;  and 

it  offers  the  opportunity  to be  multilingual. 

17 

71. 

72. 

73. 

74. 

75. 

76. 

77. 

It should be emphasised that a network of distributed databases is desirable not only because 
of  the  technical  advantages  it  offers,  but  also  because  it  maintains  the  sound  practice  of 
doing the work as close as possible to the source. This would  also ensure  compliance with 
the  principle  of  subsidiarity. 

An  electronic  network  of  distributed  health  databases  has  over  the  last  three  years  been 
developed to a pilot level through the ENS-CARE project, which received financial  support 
from  the  Commission.  The  establishment  of  a  network  of  this  kind  aiming  at  facilitating 
the telematic interchange of data between  national  administrations  is the object  of the IDA 
project,  which  includes  health  monitoring  as  one  of  several  sectors to  be  covered. 

A  network  of  distributed  databases  would,  therefore,  be  the  preferred  method  for  the 
purposes  of the  Community  health  monitoring  system.  As  such  it  would  have to build  on 
the experience  gathered  so far  from  the interchange  of  certain  comparable  health  data and 
indicators,  and  would  rely  on  the  infrastructure  currently  being  developed  under  the  IDA 
programme.  The  present  programme  would  allow  the  content  of  the  information  in  this 
system  to  be  properly  specified  with  respect  to  all  data  and  indicators  included  in  the 
Community  health monitoring  system.  The Commission  will  encourage the Member  States 
to  participate  and  collaborate  closely  in  the  development  of  a  network  of  distributed 
databases. Relevant  international  organisations will  be invited to participate  as appropriate. 

VIII. 

ANALYSES 

Measuring  health  status and  health  determinants  is only  a first step, under the  Community 
health monitoring  system  to be put in place through  this programme,  towards  contributing 
to  ensuring  a  high  level  of  health  protection.  To  achieve  maximum  usefulness,  the 
information  contained  in  the  system  must  be  fully  utilised.  This  will  require  a variety  of 
analyses to be performed,  some annually, some periodically, and others on an ad-hoc basis. 

On an annual basis, it will be necessary to monitor a set of health indicators which  together 
provide an overall  picture of health in the Community.  This will  help in the elaboration  of 
Community  health  status reports.  In addition,  it will  be necessary  to analyze indicators by 
population  subgroups (e.g.,  sex- and age-group, residence,  socio-economic  status) in  order 
to ascertain whether there are unacceptable differences  across subgroups, and problem areas, 
and to make  appropriate  inputs to the  planning  of  programmes  and  actions  which  address 
such  problems. 

The indicators will  also have to be analyzed  with  respect  to trends over time  to  determine 
whether  or  not  the  trends  are  reflecting  the  objectives  desired  by  policy. 

An  important  task  will  be  to  identify  the  major  sources  of  mortality  and  morbidity  in  the 
Community.  This  will  also  include  identifying  variations  in  mortality  and  morbidity  by 
region  and  population  subgroup.  Such  identification  will  then  have to be supplemented  by 
analysis of the determinants of these sources of morbidity  and mortality  in order to develop 
effective  policy  tools.  In this context,  it may  be necessary  to identify  and  analyze  national 
health  policies  that  have  been  shown  to  be  effective. 

78. 

79. 

80. 

81. 

82. 

Analyses of the relationship between various health determinants will also be important «and 
may  require the fielding  of  ad-hoc surveys to obtain the necessary  information  if the latter 
is not  routinely  available. Whilst  fully  respecting  data  protection  legislation  requirements, 
as stated at the outset,  it would be possible to use data at the level of the individual  in order 
to validate, in the context of such analyses, existing and proposed health indicators. However, 
the  data  used  should  not  be  such  as to  make  possible  the  identification  of  any  particular 
individual. 

Having  valid  indicators  will  also  contribute  to  improving  the  information  available  for 
epidemiological  studies of the major  causes of mortality  and morbidity.  This will  be of use 
not  only  in the design  of new health  policies but  also in the evaluation  of past and  current 
policies. 

The Community health monitoring system will also assist in the analysis of the health impact 
of other Community policies, as stated in the Commission communication on the  framework 
for  action  in  the  field  of  public  health,  help  in  identifying  conflicting  requirements,  and 
contribute  in  cost-benefit  evaluations  of  particular  programmes  and  actions. 

The analyses described above will have to be carried out in a coordinated  manner,  requiring 
the  contribution  of  and  coordination  with  several  actors,  including  specialised  European 
agencies  and centres,  such  as the EMCDDA  and the European Environment  Agency.  This 
type of activity will require the further development of an appropriate administrative capacity 
at the Community  level  capable of conducting  high-quality  analysis and responding timely 
to  diverse  requests  and  queries. 

LX.  PROPOSED  ACTIONS  FOR A  FIVE-YEAR  PROGRAMME 

The  Commission  believes  that  the  work  on  establishing  a  Community  health  monitoring 
system  covering  three  strands  of  action,  namely  the  establishment  of  Community  health 
indicators,  the  development  of  a  Community-wide  network  for  data  collection  and 
dissemination,  and  the capacity  for  and  conduct  of  analyses,  should  be initiated  by  means 
of  a  five-year  Community  action  programme.  The  actions  involved  are  described  below. 

A.  ESTABLISHMENT  OF  COMMUNITY  HEALTH  INDICATORS 

83. 

A Community  set of health  indicators is proposed to be established,  in the domains  set out 
in  Annex  A,  consisting  of: 

a sub-set of core indicators for the monitoring of Community  actions in public health, 
and 

a  sub-set  of background  indicators for  monitoring  other Community  policies and  for 
providing Member  States with  a better  means for  making international  comparisons. 

84. 

The establishment of the indicators would involve both identification  and analysis of existing 
indicators at Member State and European level, in particular as regards quality and coverage, 
as  well  as  the  selection  and/or  creation  of  specific  Community  indicators,  and  the 
development  of  definitions  for  these  indicators. 

19 

85. 

The Community health indicators will be so selected as to provide the necessary  instruments 
for: 

monitoring  areas  of  Community  priority; 

monitoring the impact of action programmes on specific  health problems, e.g.,  AIDS 
and  other  communicable  diseases,  cancer,  drugs,  accidents,  health  promotion,  rare 
diseases; 

monitoring  developments  in  health  status  and  its  determinants  in  the  Community. 

86. 

The  establishment  of  Community  indicators  would  have to  take  account  of: 

user  needs  and  specifications; 

inventories  of the  data  currently  available  in  Member  States; 

87. 

88. 

89. 

definition  and methodologies of collection used in Member  States, in the Community, 
and  in  relevant  international  organisations; 

proposals  for  definitions  and  quality  norms,  such  as  validity,  reliability,  and 
comparability. 

The Commission intends to ensure that the set of Community indicators is kept under review 
to ensure that it is capable of responding, if required, to new priorities and changing needs. 

The Commission  will  also support  the assessment  of  the feasibility  and  cost-effectiveness 
of developing health resource statistics, including an examination  of the possibility  of using 
satellite  national  accounts  as  ajramework. 

B.  DEVELOPMENT  OF  A  COMMUNITY-WIDE  NETWORK  FOR  DATA 

COLLECTION  AND  DISSEMINATION 

In order to make Community  health data and indicators readily  available to Member  States, 
the Commission  intends,  as the best  means  of health  data  collection  and  dissemination,  to 
promote the establishment  of a Community-wide network, the backbone of which  relies on 
telematics, and which links the competent authorities in the Member States, and would assist, 
under  this  programme,  in  the  content  specifications  for  the  network  using  distributed 
databases. The relevant work would take place in parallel with the effort  under the IDA and 
the  G-7  health  projects.  However,  as the  electronic  network  for  interchange  of  data  may 
not be fully  operational in the early stages of the programme, other appropriate  mechanisms 
may,  as  necessary,  be  considered  as  a  stop  gap  for  the  purposes  of  data  collection  and 
dissemination. 

20 

90. 

91. 

92. 

93. 

94. 

C.  ANALYSES 

T  ~ 

Each year, the Commission  publishes a report on the health  status of the Community.  This 
health  status report will  draw,  as appropriate, from  the health  data and  indicators  collected 
through  the  Community  health  monitoring  system.. 

The Commission  intends to draw on information  generated through  the system in  analysing 
and  reporting  on  selected  health  determinants  (e.g.,  smoking,  alcohol  consumption)  and 
comment,  if  appropriate,  on the need  for  action.  Similarly,  the Commission  intends to use 
data available  through  the system  in  analysing  the impact  on  health  of Community  public 
health  programmes  and  actions,  as well  as the  impact  of  other  policies. 

Finally, the Commission  intends to make available information  material  on matters arising 
out of this work which may  serve the needs of Member  States, international  organisations, 
health  professionals  and  bodies,  interest  groups,  and  the general  public. 

X.  CONSULTATION,  ASSESSMENT,  AND  REPORTS 

A.  CONSULTATION  AND  PARTICIPATION  MECHANISMS 

In  seeking  to  establish  a  Community  health  monitoring  system  through  an  initial  5-year 
programme, the Commission will rely on close collaboration with the Member  States in all 
questions relating to reporting,  conversion, harmonisation,  description of data and  selection 
of  specific  indicators.  Most  of the data needed  for  the establishment  of indicators  relevant 
to  a  Community  health  monitoring  system  will  have  to  be  made  available  from  Member 
States sources. Moreover,  much  of the work  related  to the harmonisation,  conversion,  and 
description  of  data  must  be  carried  out  by  the  competent  authorities  in  Member  States. 

In implementing the programme, the Commission  intends to have recourse to a Committee 
made  up  of  Member  States  experts,  representing  both  users  and  producers  of  health 
information.  In the domain of Community health and safety  statistics, existing Committees, 
such as the Statistical  Programme  Committee19,  and the European  Advisory  Committee on 
statistical  information  in  the  economic  and  social  spheres20  (CEIES)  will  be  associated» to 
the work  as  appropriate.  Furthermore,  other  existing  Community  committees,  such  as the 
EFILASS Committee21, and the Programme committee of the Biomedical and Health research 
programme22,  will  be  associated  to the  work  as  appropriate. 

Council  Decision  89/382/EEC,  OJ  No  L  181, 28.6.89,  p. 47 

Council  Decision  91/116/EEC,  OJ  No L  59,  6.3.91,  p. 21 

1 

Council  Decision  of  7 December  1994,  OJ  No  L  331  21.12.94,  p.l 

Council  decision  94/382/  EC,  OJ  No  L 361, 31.12.94,  p  42 

21 

95. 

96. 

In view of the important role of the WHO and the OECD in the development  of international 
health information, the Commission will maintain appropriate links with them. It also intends 
to  foster  cooperation  in  this  field  with  other  international  organisations  and  with  third 
countries. 

Where  appropriate,'the  Commission  will  encourage  participation  of  professionals,  non 
governmental  organisations  engaged  in  health  monitoring  and  European  networks  for  the 
• exchange of  health  data by  drawing upon  their  experience in  specific  areas when  initiating 
and  implementing  actions  on  the  development  of  health  data  and  indicators  under  the 
proposed  programme.  ' 

B.  EVALUATION  REPORTS 

97. 

Assessment  of  the programme  will  be  provided  in  two  reports: 

a mid-term  report to the Council, the European  Parliament,  the Economic  and  Social 
Committee,  and  the  Committee  of the  Regions.  The  purpose  of  the  mid-term  report 
is  to  ensure  that  the  Community  institutions  and,  through  them,  all  the  parties 
concerned,  are  kept  fully  informed  on  the  progress  of  the  actions  undertaken  in  the 
context of this action plan. It will include information  on the projects  supported  under 
the  different  actions. 

a  final  report  on  the  implementation  of  the  programme,  which  will  include  an 
evaluation  of  the  actions  undertaken,  will  be  submitted  to  the  above-mentioned 
institutions  by  the  Commission  after  the  completion  of  the  programme. 

C.  GENERAL  INFORMATION  ACTIVITIES 

98. 

In addition  to the information  activities  contained  in the programme,  the Commission  will 
ensure that the general public and all parties concerned have access to reports on the actions, 
studies,  and  assessments  undertaken. 

o? 

ANNEX A 

Domains  in  which  Health  indicators  may  be established  under  a future  Community  health 
monitoring  system 

A. 

Health  Status 

1. 

Life  expectancy: 

life  expectancy  at  certain  ages 
health  expectancies 

2.  Mortality: 

overall 
causes  of  death 
disease-specific  survival 

3.  Morbidity: 

disease-specific  morbidity 
co-morbidity 

4. 

Functioning  and  quality  of  life: 
self-perceived  health 
physical  disability 
activity  limitations 
functional  status/ability 
health-related  work  loss 
mental  health 

5. 

Anthropometric  characteristics 

B. 

Life  Style  and  Health  Habits 

1. 

Tobacco  consumption 

2. 

3. 

4. 

5. 

6. 

7. 

Alcohol  consumption 

Illicit  drug  consumption 

Physical  activities 

Diet 

Sexual  behaviour 

Other  health  promotion-related  activities 

23 

C. 

Living  and  working  conditions 

1. 

Employment/unemployment: 
-  . 

occupation 

2.  Work  environment: 

accidents 
exposure  to  carcinogenic  and  other  dangerous  substances 
occupational  health 

3. 

4. 

Housing  conditions 

Home  and  leisure  activities: 
accidents  at  home 
- 
leisure 

5. 

Transport: 

automobile  accidents 

6. 

External  environment. 
air  pollution 
water  pollution 
other  types  of  pollution 
radiation 
exposure to carcinogenic and other dangerous substances outside the work environment 

D. 

Health  Protection 

1. 

Sources  of  financing 

2. 

Facilities  /  Manpower 

Health  resource  utilisation 
Health  care  personnel 

3. 

Cost  /  Expenditure 

In  patient  care 
Out  patient  care 
Pharmaceutical  products 

4. 

Consumption  /  uses 
In  patient  care 
Out  patient  care 
Pharmaceutical  products 

5. 

Health  promotion  and  disease  prevention 

24 

E. 

Demographic  and  Other  Social  Factors 

1.  Gender 

2. 

3. 

4. 

5. 

6. 

Age 

Civil  status 

Region  of  residence 

Education 

Income 

7. 

Population  subgroups 

8.  Health  insurance  status 

F. 

Miscellaneous 

1. 

Product  safety 

2. 

Others 

25 

Proposal  for  a 
EUROPEAN  PARLIAMENT  AND  COUNCIL  DECISION 

95/0238  (COD) 

adopting  a programme  of  Community  action  on 
health  monitoring  in  the  context  of  the 
framework  for  action  in  the  field  of 
public  health 

ik 

1. 

2. 

3. 

4. 

5. 

EXPLANATORY  MEMORANDUM 

In  its  Communication  of  24  November  1993  on  the  framework  for  action  in  the  field  of 
public health,  the Commission  defined  a framework  for  future  Community  action in  order 
to attain the objectives on health protection laid down in Articles 3(o) and  129 of the Treaty 
establishing  the  European  Community.  The  role  of  the  Community  is  identified  as 
underpinning  the  efforts  of  the  Member  States  in  the  public  health  field,  assisting  in  the 
formulation and implementation of objectives and strategies, and contributing to the provision 
of health protection across the Community, setting as target the best results already obtained 
in  a given  area  anywhere  in  the  Community. 

In  initiating  action  under  Article  129, the  Community  has to  address  itself  to  preventing 
disease  and  protecting  health.  A prerequisite  for  such  action  is  knowledge  about  existing 
problems,  their  nature,  and  their  extent.  It  is  therefore  necessary  to  measure  the  changes 
in  health  as well  as the impact  of  policies,  programmes,  and  actions both  in the  Member 
States  and  at  Community  level.  There  is  also  a  need  to  promote  the  sharing  and 
dissemination  of  relevant  information.  Based  on  the  criteria  laid  down  in  the  above-
mentioned  Commission  communication,  health  monitoring  at  Community  level,  and  in 
particular  health  data  and  indicators,  has  been  identified  as  an  essential  means  for  the 
acquisition  and  sharing  of  such  knowledge,  and,  therefore,  as  a  priority  for  Community 
action. 

The European  Parliament  and  the Council  have  also, in  a number  of  resolutions,  stressed 
the  importance  of  having  adequate  and  valid  health  data to  map  out  health  situations  and 
trends,  and  to  assist  in the  development  of  Community  and  Member  States' actions in the 
field  of  public  health.  The  European  Parliament  underlined,  in  particular,  the  need  for 
collection  and  examination  of  health  data  from  the  Member  States  and  the  assessment  of 
the  effects  of  various  policies  on  health.  Similarly,  the  Council,  has  emphasised  that  it  is 
necessary to have an accurate assessment of health needs, an estimation of avoidable deaths, 
and  an  evaluation  the  effects  of  socio-economic  factors  on  health. 

The  efforts  of  the  Commission  in  this  area  have  concentrated  so  far  on  the  needs  of  the 
Community and the Member States, and on identifying  ways to obtain maximum value from 
the involvement  of the Community.  To this end, the Commission  has  consulted  experts in 
this  field  and,  with  the  assistance  of  Member  States'  representatives,  conducted  a  review 
of existing  health  data and  indicators at the Community  level, their  sources, coverage,  and 
importance, and obtained advice and recommendations on the development of a Community 
action  programme  on  health  monitoring. 

The  overall  aim  of  the  proposed  5-year  action  programme  is  to  develop  a  high-quality, 
policy-oriented  health  monitoring  system.  This  system  should  allow  the  measurement  of 
health status and health determinants throughout the Community.  It should provide Member 
States with  indicators and data for  supporting their national  health  policies and should  also 
facilitate  the planning, monitoring, and evaluation  of Community  programmes and actions, 
in  compliance  with  the  principle  of  subsidiarity. 

27 

6. 

7. 

8. 

9. 

10. 

11. 

The Community health monitoring system would also involve the development of a networlc 
for  the purpose of collection  and dissemination  of health  data  and  indicators,  in  particular 
using the possibilities offered  by telematics, and the development  of a capacity to undertake 
the  analysis  of  health  data  and  the  production  of  reports,  reviews  and  other  health 
information  material. 

The  principles  underlying  the  development  of  such  a  system  include  building  on  readily 
available  European  health  data  and  indicators,  such  as  those  held  by  Member  States, 
international  organisations,  and  European  networks,  avoiding  both  any  unnecessary 
duplication of work and the placing of unnecessary burdens on Member  States which already 
transmit health data to a number of international  organizations  and  networks, assessing the 
costs  and  benefits  of  developing  the  various  parts  of  the  system,  and  allowing  as  much 
flexibility  as  possible  to  permit  adaptation  whilst  encouraging  data  comparability  and 
progressive  harmonisation. 

The health indicators to be collected through the Community health monitoring system may 
be  divided  into  two  types:  core indicators  and  background  indicators.  Core  indicators  are 
those  indicators  which  are  essential  to  Community  health  policy.  These  include  data  on 
health  status  as  well  as  on  health  determinants,  e.g.,  alcohol  and  tobacco  consumption. 
Background  indicators are those indicators which are linked  indirectly  to public health but 
which are nevertheless important for health policy purposes. As priorities are likely to change 
over time,  the indicators  to be  collected  (both  core  and  background)  will  have  to  cover  a 
wide  range  to  permit  a  good  understanding  of  the  interplay  of  various  factors  impinging 
on  health  and  enable  anticipation  of  future  problems. 

The Commission attaches major importance to makingCommunity health information readily 
available to  Member  States.  Therefore,  the  Commission  will,  as the  best  means  of  health 
data collection and dissemination,  promote the development of a Community-wide  network 
using in  particular,  telematics,  which  would  link the  competent  authorities  in the  Member 
States.  Such  a system  would  minimise  the burden  of  data  collection  imposed  on  Member 
States, provide  easy  and timely  adaptation  and  access to the information  placed  on  it,  and 
be  more  cost-effective  compared  to  alternative  collection  methods. 

Under  the  ENS-CARE  programme  of  the  third  framework  programme  on  Research  and 
Technological Development, the infrastructure  for such a system has already been developed 
in  apilot  project.  This  infrastructure  is  now  being  further  developed  under  the  project  of 
telematic  interchange  of  data  between  administrations  (IDA)  and  under  the  Information 
*  Society  health  projects  of  the G-7  Member  States. Under the proposed  5-year  programme 
on health monitoring, the Commission will encourage the Member  States to participate and 
collaborate  closely  in  the content  specifications  of  this  system,  which  will  use  distributed 
databases  as  its  backbone,  and  would  promote  participation  of  competent  international 
organizations  and  third  countries  as  appropriate. 

The  Community  health  monitoring  system  will  provide  an  opportunity  for  a  variety* of 
analyses to be undertaken  on a regular or on an ad hoc basis. These analyses could  include 
health  status  and  health  trends  reports,  analyses  of  specific  health  problems  and  health 
determinants,  and  analyses  of  thé  health  impacts  of  other  policies.  The  dissemination  of 
relevant  information  material  will  be  supported. 

28 

12. 

Assessment of the action programme on health monitoring will  be provided in two reports. 
A  mid-term  report  reviewing  progress  and  a  final  report  on  the  implementation  of  the 
programme.  These  reports  will  incorporate  information  on  Community  financing  in  the 
various fields of action as well  as the results of the evaluations and will  be transmitted to 
the Council and the European Parliament, as well as to  the Economic and Social Committee 
and the Committee  of the Regions. 

29 

ADDENDUM 
with  respect  to  the  principle  of  subsidiarity 
to  the  explanatory  memorandum  of  the  proposal  for  a 
European  Parliament  and  Council  decision 
adopting  a programme  of  Community  action  on 
health  monitoring  in  the  context  of  the 
framework  for  action  in  the  fields  of 
public  health. 

a. 

Quels  sont  les objectifs  de  l'action  envisagée  par rapport  aux obligations  pesant  sur la 
Communauté? 

In  accordance  with  Article  129  of  the  Treaty  establishing  the  European  Community,  the 
Commission  is presenting proposals  for adoption by the European Parliament  and the Council 
of  incentive measures, having as their objective  to contribute towards ensuring  a high level of 
human  health  protection  by  encouraging  cooperation  between  the  Member  States,  lending 
support to their action, promoting coordination of their policies and programmes, and  fostering 
cooperation  with  third  countries  and  the  competent  international  organisations  in  the  sphere 
of  public health. The objective  of the present proposal by the Commission  is the  development 
of  a health  monitoring  system  through  a  5-year programme  of action  which,  through  the  full 
participation of the Member States in its design and implementation, would permit their mutual 
• cooperation  and  coordination  in  collecting,  processing  and  sharing  health  data  and  indicators 
necessary  for  measuring  the  impact  of  health  policies,  health  status  and  trends  and  health 
determinants,  both  at  the  Community  and  Member  State  level,  thus  permitting  a  better 
planning  and  implementation  of their actions aiming  at ensuring a high-level  of human  health 
protection. 

b. 

L'action  envisagée  relève-t-elle  d'une  compétence  exclusive  de  la  Communauté  ou 
d'une  compétence  partagée  avec  les  Etats  membres? 

The  proposed  decision  for  a  programme  of  action  on  health  monitoring,  pursuant  to  Article 
129  of  the  E.C.  Treaty,  comes  under  the  mixed  competence  of  the  Community  and  the 
Member  States. 

c. 

Quelle  est  la  dimension  communautaire  du  problème? 

The  situation  at  present  is that  neither  the  international  organisations  competent  in the  sphere 
of  public  health,  nor  the  Community  or the  Member  States possess appropriate  and  sufficient 
data  and  indicators  about  health  status  and  the  impact  of  health  actions  and  policies. 
The  proposed  programme  sets  up  a  series  of  mechanisms  which  will  facilitate  the  gathering 

Ô M LM 

and  analysis  of  data  at  Community  level  and  also  be  of  assistance  to  Member  States  in 
information  collection  and  evaluation  of  health  data  and  indicators. 

d. 

Quelle  est  la  solution  la  plus  efficace  par  comparaison  entre  les  moyens  de  la 
Communauté  et  ceux  des  Etats  membres? 

The  proposed  programme  of  action  involves  the  development  of  a  health  monitoring  system 
using  as  a  basis  what  already  exists  at  the  European  level  on  health  data  and  indicators, 
including those held by Member States, international organisations, and European networks,and 
building  on it while avoiding  any unnecessary  duplication  of work by carefully  selecting  and 
checking  with  the  Member  States  the  data  and  indicators  needed,  and  by  associating to  this 
work the international organisations and networks to which the Member States already transmit 
data. 

e. 

Quelle plus-value concrète apporte Taction envisagée de la Communauté et quel serait 
le  coût  de  l'inaction? 

The  actions  to  be  implemented  under  the  proposed  programme  will  yield  added  value  in  a 
number  of  ways. 

l.They  will  facilitate  the  production  of  health  data  and  indicators,  not  currently 
existing,  which  are valuable  in the assessment  of Community  programmes  and  actions 
in  the  field  of  health. 

2.They  will  assist  in  the  development  of  more  accurate,  comparable  and  compatible 
health  data  and  indicators  at  national  level.  This  will  enable  better  comparisons  to  be 
made  and  should  make  it  easier  for  Member  States  to  exchange  and  share  important 
information. 

3.They  will  lead  to  the  establishment  of  a  network  for  the  exchange  of  data  and 
indicators and this will be undertaken  in the framework  on the Community  programme 
in the  Interchange  of  Data  between  Administrations  (IDA). 

4  They  will  enable  the  production  of  comprehensive  and  detailed  reports  on  health 
status and  trends and on the impact of health  policies. Existing reports on suGh matters 
are  generally  not  of  a  high  enough  quality  since  the  required  data  and  indicators  are 
not  available.  The  programme  is  intended  to  support  the  production  of  these. 

In the  absence  of  the  proposed  programme  of  action  and the development  of the  high-quality 
information  and  indicators  that  is its aim,  neither  the Community  nor the  Member  States will 
have  a  fully  adequate  basis  on  which  to  plan  future  health  policies  and  programmes  and 
evaluate  those  which  currently  exist.  Controlling  the  rising  costs  of  health  is  a  central  issue 
across the Community. The absence of accurate information  and indicators on health status and 
health activities makes it all the more difficult  to address this issue, and to achieve a high level 
of  health  protection  efficiently  and  effectively. 

& c 

f. 

Quelles modalités d'action  sont à la disposition  de la Communauté? 

The action envisaged in the area covered by the Commission proposals can only be undertaken 
by a  European  Parliament  and  Council decision  adopting  incentive  measures, that  is by the 
financial  support of the activities contained  in the 5-year  programme. 

g. 

Une réglementation uniforme est-elle nécessaire ou suffit-il  d'une directive.posant des 
objectifs  généraux en renvoyant  l'exécution  au niveau des Etats membres? 

There  is  no  need  for  regulatory  provisions  in  this  matter;  the  actions  envisaged  by  the 
proposed  programme  aim at the development  of  a health monitoring  system  which requires 
cooperation  of  the  Member  States and  lending  support to  their  action.  According  to Article 
129, no harmonisation  measures can be taken in this respect. 

£<5  ^ 

Proposal  for  a 

EUROPEAN  PARLIAMENT  AND  COUNCIL  DECISION 

95/0238  (COD) 

adopting  a  programme  of  Community  action  on 

health  monitoring  in  the  context  of  the 

framework  for  action  in  the  field  of 

public  health 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  treaty  establishing  the  European  Community,  and  in  particular  Article  129 

thereof, 

Having  regard  to  the  proposal  from  the  Commission1, 

Having  regard  to  the  opinion  of  the  Economic  and  Social  Committee2, 

Having  regard  to  the  opinion  of  the  Committee  of  the Regions3, 

Acting  in  according  with  the  procedures  referred  to  in  Article  189b  of  the  Treaty, 

1 

2 

3 

OJ  No 

OJ  No 

OJ  No 

he 

1. 

Whereas,  in accordance with point (o)  of  Article  3 of the Treaty,  Community  action  must 

include a contribution  of the Community towards the achievement  of a high level  of health 

protection; whereas Article 129 expressly provides for Community competence in this field, 

in  particular  by  encouraging  cooperation  between  the  Member  States  and,  if  necessary, 

lending  support  to  their  action; 

2. 

Whereas the Council, in its resolution4 of 27 May  1993 on future action in the field of public 

health, considered that improved collection, analysis and distribution  of health data, as well 

as an improvement  in the quality  and comparibility  of  available  data,  are essential  for  the 

preparation  of  future  programmes; 

3. 

Whereas,  the  European  Parliament,  in  its report  on  public health  policy  after  Maastricht5, 

has stressed the importance  of having sufficient  and relevant information  as a basis for  the 

development  of  Community  actions  in  the  field  of  public  health;  whereas  the  European 

Parliament called on the Commission to collect and examine health data from Member States 

and  analyse  trends  and  assess  the  effects  of  public  health  policies,  as well  as the  impact 

of  other  policies; 

4. 

Whereas the  Commission,  in its Communication  of 24 November  1993  on the  framework 

for  action in the field of public health6, identified  increased  cooperation  on  standardisation 

and  collection  of  comparable/compatible  data  on  health,  and  the  promotion  of  systems  of 

4 

OJNo.  C174,  25.6.1993,  p.l 

OJ  No.  C329,  6.12.93,  p.375 

COM(93)  559 final 

31 

health monitoring and surveillance as a prerequesite for the establishment of a framework 

for  supporting Member  States' policies and programmes;  and  whereas the area of health 

monitoring, including health data and indicators, has been identified  as a priority area for 

proposals on multi-annual  Community  programmmes in the field of public health; 

5. 

Whereas in its resolution of 2 June 19947, the Council indicated that the collection of health 

data should be accorded priority and invited the Commission to present relevant proposals; 

whereas  the  Council  considered  that  data  and  indicators  used  should  include  measures 

relating  to  the  quality  of  life  of  the  population,  accurate  assessments  of  health  needs, 

estimations of the avoidable deaths from the prevention of diseases, socio-economic factors 

in  health  among different  population  groups, and, where  appropriate  and  if the Member 

States judge it necessary, health aid, medical  practices, and the impact of  reforms; 

6. 

Whereas health monitoring at the Community level is essential for the planning, monitoring, 

and assessment of Community actions in the field of public health, and the monitoring and 

assessment  of the health impact of other Community policies; 

7. 

Whereas health monitoring, in this context, encompasses the establishment of Community 

health indicators, the collection, dissemination, and analysis of Community health data and 

indicators; 

OJNo.  C165,  17.6.94, p.l 

32 

8. 

Whereas  in  its  Decision  on  the framework  programme  for priority  actions in the field  of 

statistical  information  1993 to  1997 the Council8 has identified  under the heading "health 

and  safety"  analysis  of  mortality  and morbidity  by  cause  as one  of  the  fields  of  priority 

actions under the sectoral programmes for social  policy, for economic and social  cohesion 

and consumer protection; 

9. 

Whereas  the  Council9  in  its  Decision  adopting  a  specific  programme  on  research  and 

technological  development, including demonstration, in the field of biomedicine and health 

(1994-1998) identified a specific research task on coordination and comparison of European 

health data, including nutritional data, from the Member States, and whereas this was taken 

up in the  relevant  research work programme; 

10. 

Whereas health monitoring at Community level should enable measurements of health status, 

trends and determinants to be carried out, facilitate the planning, monitoring and evaluation 

of Community programmes and actions, and provide Member States with health information 

supporting  the  development  and evaluation  of their health policies; 

11. 

Whereas,  in  order  to  give  full  effect  to  requirements  and  expectations 

in  this  area  a 

Community  health  monitoring  system  should be developed,  comprising  the establishment 

of health indicators and the collection of health data, a network for transmission and sharing 

of  health  data  and  indicators,  and  a  capacity  for  analysis  and  dissemination  of  health 

information; 

OJ No.  L 219,  28.8.93,  p.l 

OJ No  L 361,  31.12.94,  P.40 

33 

12. 

Whereas available options and possibilities for developing the various parts of a Community 

health  monitoring  system  should  be  carefully  assessed  with  respect  to  the  desired 

performance, flexibility and the costs and benefits involved; whereas a Community health 

monitoring system should include the definition of sets of Community health indicators and 

the collection  of the data necessary for the establishment  of such indicators; 

13. 

Whereas, Community health data and indicators should draw from readily available European 

data  and  indicators,  such  as  those  held  by  Member  States  or  transmitted  by  them  to 

international  organisations,  so as to avoid unnecessary  duplication  of work; 

14. 

Whereas a Community health monitoring system would benefit  from  the establishment of 

a network, the backbone of which relies on telematics, for  the collection  and distribution 

of Community  health data and indicators; 

15. 

Whereas  a Community  health  monitoring  system  should  be capable  of  encouraging  and 

assisting  in  the  production  of  analyses  of  health  status,  trends,  and  health  problems 

throughout the Community, and in the availability and dissemination of health information; 

16. 

Whereas overriding considerations in the development of a Community health  monitoring 

system are the respect of legislative provisions on data protection, and the implementation 

of appropriate confidentiality  and security  arrangements; 

34 

17. 

Whereas a multiannual programme should be launched within the context of the  framework 

for action in the field of public health, in order to permit the development  of a Community 

health  monitoring  system  and  of  appropriate  mechanisms  for  its  evaluation; 

18. 

Whereas, in  accordance  with  the principle  of  subsidiarity,  action  on  matters not under,the 

exclusive  competence  of  the  Community,  such  as  action  on  health  monitoring,  must  be 

undertaken by the Community only when, by reason of their scale or effects,  it may be better 

carried  out  at  Community  level; 

19. 

Whereas  policies  and  programmes  formulated  and  implemented  at  Community  level,  in 

particular those undertaken  in the context  of the framework  for  action in the field of public 

health, should be compatible with the targets and objectives of Community action on health 

monitoring; whereas the implementation of Community actions on health monitoring should 

be coordinated  with and take account of relevant research  activities under the Community's 

Framework Programme for Research and Technological  Development; whereas projects on 

telematics  applications  in  the  health  field  under  the  Community's  RTD  Framework  must 

be closely coordinated with Community actions on health monitoring;  whereas actions under 

the Community's framework  programme for statistical information,  the Community  projects 

in the field of telematic interchange of data between  administrations (IDA) and G-7 health-

related projects must be closely coordinated with the implementation of Community  actions 

on health  monitoring;  whereas the work undertaken  by the  specialised  European  agencies, 

such as the EMCDDA and the European Environment Agency, should be taken into account; 

35 

20. 

Whereas  cooperation  in  this  area  with  the  competent  international  organisations  ancTwith 

third  countries  should  be  fostered; 

21. 

Whereas it is important  that  the Commission  ensure implementation  of the programme  in 

close  cooperation  with  the  Member  States; 

22. 

Whereas an agreement on a "modus vivendi" between the European Parliament, the Council 

and  the  Commission  concerning  measures implementing  acts  adopted  in  accordance  with 

the  procedure  laid  down  in  Article  189b  of  the  EC  Treaty  was  reached  on  20  December 

1994; 

23. 

Whereas, from  an operational  point of view, the investments made in the past both in terms 

of the development of Community networks and cooperation with international  organisations 

competent  in this  field  should  be  safeguarded  and  further  developed; 

24. 

Whereas unnecessary  duplication  of effort  should  be  avoided  by  the joint  development  of 

methodologies, comparison and conversion criteria and techniques, progressively harmonised 

data  collection  tools  such  as  surveys,  questionnaires  or  parts  thereof,  and  content 

specifications  for  health  information  to be shared  using in particular a telematics  network; 

25. 

Whereas,  in  order  to  increase  the  value  and  impact  of  the  programme,  a  continuous 

assessment of the measures undertaken should be carried out, with particular regard to their 

effectiveness  and the achievement  of objectives both at national  and Community  level  and, 

where  appropriate,  the  necessary  adjustments  should  be  made; 

36 

26. 

Whereas  this Decision  lays down,  for  the entire  duration  of  the programme,  a  financial 

framework  constituting the principal  point of reference, within the meaning of point  1  of 

the Declaration of the European Parliament, the Council and Commission, of 6 March 1995, 

for the budgetary  authority  during the annual budgetary  procedure; 

27. 

Whereas this programme must be of five-year duration in order to allow sufficient  time for 

actions to be implemented to achieve the objectives set, 

HAVE DECIDED AS FOLLOWS: 

Article 1 

Establishment  of the programme 

1.  A  programme  of  Community  action  on  health  monitoring,  hereinafter  referred  to  as  "this 

programme", is hereby  adopted for the period  1  January  1997 to 31 December  2001 within the 

framework  for  action  in the field of public health. 

2.  The aim of this programme is to establish a Community health monitoring system which allows 

the measuring of health status, trends and determinants throughout the Community, facilitates the 

planning, monitoring, and evaluation of Community programmes and actions, and provides Member 

States with  appropriate  health  information  to make comparisons and  to  support  their  national 

health policies. 

37 

3.  The actions to be implemented under this programme and their specific  objectives are set out in 

the Annex  under the headings: 

A.  Establishment  of  Community  health  indicators 

B.  Development  of  a Community-wide  network  for  sharing health data 

C.  Analyses  and reporting 

Article  2 

Implementation 

1.  The  Commission  shall  ensure  implementation,  in  close  cooperation  with  the Member  States,  of 

the  actions  set  out  in  the  Annex  in  accordance with  Article  5. 

2.  The  Commission  shall  cooperate  with  institutions  and  organisations  active  in the  field  of  health 

monitoring. 

Article  3 

Budget 

1.  The total  appropriation  for implementation  of this programme for the period referred  to in  Article 

1  shall  be  ECU  13.8  Million. 

38 

2.  The  annual  appropriations  shall  be  established  by  the  Budgetary  Authority  in  accordance  with 

the  financial  perspectives. 

Article  4 

Consistency  and  complementarity 

The Commission and the Member States shall ensure that there is consistency and complementarity 

between  actions  to  be  implemented  under  this. programme  and  other  relevant  Community 

programmes  and  initiatives,  including  the framework  programme  for  statistical  information,  the 

projects in the field of telematic interchange of data between  administrations, and the  framework 

programme for research and technological development and in particular the telematics applications 

of  the  latter. 

Article  5 

Committee 

1.  The Commission  shall be assisted by a Committee composed  of two members designated by each 

Member  State and  chaired  by  a representative  of the Commission,  hereinafter  referred  to as "the 

Committee". 

2.  The representative  of the Commission  shall  submit to the Committee draft  measures  concerning, 

in  particular: 

39 

(a) 

the Committee's rules of procedure; 

(b) 

an annual  work programme indicating the priorities for  action; 

(c) 

the arrangements,  criteria, and procedures for  selecting and financing  projects  under this 

programme, including those involving cooperation with international organisations competent 

in the field of public health and participation  of the countries mentioned  in Article 6(2); 

(d) 

the evaluation procedure; 

(e) 

the arrangements for  reporting, conversion,  and harmonisation  of the data; 

(f) 

the arrangements for  the definition  and selection of indicators; 

(g) 

the arrangements for the content specifications necessary for the development and operation 

of the relevant networks. 

3.  In  addition,  the  Commission  may  consult  the  Committee  on  any  other  matter  concerning  the 

implementation  of this programme. 

The representative of the Commission  shall  submit to the Committee a draft  of the measures to 

be  taken.  The  committee  shall  deliver  its  opinion  on  the  draft  within  a  time  limit  which  the 

chairperson may lay down according to the urgency of the matter, if necessary by taking a vote. 

40 

The opinion shall be recorded in the minutes; in addition, each Member  State shall have the rigfit 

to  ask  to have its  opinion  recorded  in  the  minutes. 

The Commission  shall take the utmost account of the opinion delivered by the Committee. It shall 

inform  the  Committee  of  the  manner  in  which  its  opinion  has been  taken  into  account: 

4.  The  representative  of the  Commission  shall  keep the  Committee  regularly  informed  about: 

financial  assistance  granted  under  this  programme  (amounts,  duration,  breakdown,  and 

recipients); 

Commission  proposals  or  Community  initiatives  and  the  implementation  of  programmes 

in  other  policy  areas  which  are  relevant  to  the  achievement  of  the  objectives  of  this 

programme,  with  a  view  to  ensure  the  consistency  and  complementarity  required  under 

Article 4. 

Article  6 

International  cooperation 

1.  In the course of implementing this programme, cooperation  with non-member  countries and with 

international  organisations competent  in the field of public health,  in particular the World  Health 

Organization  and the Organization  for Economic Cooperation  and Development  shall be  fostered 

and  implemented  in  accordance  with  Article  5. 

41 

2.  This programme shall be open to participation by the associated countries of Central and Eastern 

Europe (CCEE), in accordance with the conditions laid down in the Additional Protocols to the 

Association Agreements relating to participation in Community programmes to be concluded with 

those countries. This programme shall be open to participation by Cyprus and Malta on the basis 

of  additional  appropriations  in  accordance  with  the  same  rules  as those  applied  to  the  EFTA 

countries, in accordance with procedures to be agreed  with those countries. 

Article 7 

Monitoring and evaluation 

1, The Community,  taking into account the reports drawn  up by the Member  States and with the 

participation,  where necessary,  of independent  experts,  shall  ensure that  an evaluation  is made 

of the actions undertaken. 

42 

2.  The  Commission  shall  submit  to  the  European  Parliament  and  the  Council  an  interim  report 

halfway  through,  and a final report  on completion  of this programme.  It shall,incorporate into 

these  reports  information  on  Community  financing  in  the  various  fields  of  action  and  on 

complementarity  with  the  other  actions  referred  to  in  Article  4,  as  well  as  the  results  of  the 

evaluations. It  shall  also send them to the Economic and Social  Committee and the Committee 

of the Regions. 

Done at Brussels, 

For the European  Parliament 

For the Council 

The President 

The President 

43 

A N N EX 

SPECIFIC  OBJECTIVES  AND  ACTIONS 

A 

ESTABLISHMENT  OF COMMUNITY  HEALTH  INDICA TORS 

Objective 

To establish Community  health indicators by a critical  review  of existing health  data 

and indicators, and develop appropriate methods for the collection of comparable and 

progressively  harmonised  health  data. 

1. 

Carrying out an identification,  review and critical analysis of existing health indicators and 

data at the  European  and Member  States' level  in  order  to  identify  their  relevance,  quality 

and  coverage with  regard  to  the  establishment  of  Community  indicators. 

2. 

Creation  of a set of Community  health indicators, including  a sub-set  of core indicators  for 

the  monitoring  of  Community  programmes  actions  in  public  health,  and  a  sub-set  of 

background  indicators  for  the  monitoring  of  other  Community  policies  programmes  and 

actions, and for providing Member  States with common measures for making comparisons. 

3. 

Development of the routine collection of comparable and/or progressively harmonised  data 

in  the  Member  States,  including  support  for  the  elaboration  of  data  dictionaries,  and  the 

establishment  of  appropriate  conversion  methods  and  rules, 

44 

4. 

Contributing  to the collection  of comparable data by  supporting the elaboration  of surveys 

including Community-wide surveys in support of Community policies, or modules or agreed 

forms  of  words  for  questions  in  existing  surveys. 

5. 

Foster co-operation with international organizations competent in the field of European health 

data  and  indicators  and  networks  for  the  exchange  of  health  data  covering  specific  areas 

in  public  health,  in  order  to  enhance  comparability  of  data. 

6. 

Support  for  the  assessment  of  the  feasibility  and  cost-effectiveness  of  developing 

standardised health resource statistics with the aim of including them in a future  Community 

health  monitoring  system. 

II 

DEVELOPMENT  OF A  COMMUNITY-WIDE?NETWORK FOR SHARING  HEALTH 

DATA 

Objective 

To  enable  the  establishment  of  effective  and  reliable  transfer  and  sharing  of  health 

data  and  indicators  using  telematic  interchange  of  data  as the  principal  means. 

7. 

Encourage and support the development of a network for  sharing health data, mainly using 

telematic  interchanges  and  a  system  of  distributed  databases,  in  particular  by  the 

establishment of data specifications and of procedures with regard the to the access, retrieval, 

confidentiality  and  security  for  the  different  types  of  information  to  be  included  in  the 

system. 

45 

C 

ANAL YSES AND REPORTING 

Objective :  To  develop  methods  and  tools  necessary  for  analysis  and  reporting,  and  support 

analyses and reporting on health status, trends, determinants, and the effect  of policies 

on health. 

8. 

Encourage the development of a capacity for analyses, including comparative and predictive 

methodologies and tools, the testing of hypotheses and models and the evaluation of health 

scenarios and outcomes. 

9. 

Support for the analysis and evaluation of the impact of Community actions and programmes 

in public health. 

10. 

Support for the production and dissemination of reports and other information  material on 

health  status and trends, health determinants  and the impact on health of other policies. 

46 

FINANCIAL  STATEMENT 

1  TITLE  OF  OPERATION 

Proposal  for  a European Parliament  and Council  Decision  adopting a programme of Community 
action on health monitoring in the context of the framework  for action in the field of public health 

2  BUDGET  HEADING  INVOLVED 

B3-4306:  Health  data  and  indicators 

3  LEGAL  BASIS 

Article  3(o)  and  Article  129 of  the  Treaty  establishing  the European  Community. 

European Parliament and Council Decision adopting a programme of Community action on health 
monitoring  in  the  context  of the  framework  for  action  in  the  field  of  public  health. 

4  DESCRIPTION  OF  OPERATION 

4.1  General  objective 

Implementation of a programme aiming at contributing to the establishment of a Community-wide 
health monitoring system, in particular by the development, availability and dissemination through 
a  network  of  health  data  and  indicators,  and  to  the  establishment  of  a  capacity  for  analysis, 
evaluation,  and  comparisons.  Both  the  European  Parliament  and  the  Council  have  stressed  the 
importance  of  having  sufficient  and  relevant  information  as  a  basis  for  the  development  of 
Community  actions  in  the  field  of  public  health.  The  European  Parliament  has  called  on  the 
Commission  to collect  and examine health  data from  the Member  States and  analyse trends  and 
assess the effects  of public  health  policies  as well  as the impact  of  other  policies  on  health;  and 
the  Council  has,  in  several  acts,  and  most  recently  in  its  resolution  from  2  June  1994  on  the 
framework  for  Community  action  in  the  field  of  public  health,  stressed  the  importance  of  the 
development  of  Community  health  data  and  indicators. 

The aim  of the proposed  action  programme  on  health  data  and  indicators  is to  contribute to  the 
development of a high-quality, policy-oriented health monitoring system. This system should serve 
three  purposes:  1) to  enable  measurement  of  health  status,  trends  and  determinants  throughout 
the  Community;  2)  to  facilitate  the  planning,  monitoring,  and  evaluation  of  Community 
programmes and actions, and 3) to provide Member  States with  high  quality, comparative  health 
indicators and data which add value to their national  health information  systems and thus support 
the  development  of national  health  policies, whilst  fully  respecting  the principle of  subsidiarity. 

Measurement  of health  status, trends and determinants will be made possible by the development 
of  core  and  background  Community  health  indicators,  whereas  the  provision  of  information  to 

47 

Member States will require the development of a mechanism for the collection and dissemination 
of Community health information. 

The method for achieving these objectives consists of providing support for the establishment of 
mechanisms for collaboration among Member States, the Commission, and relevant international 
organisations in order to assess the quality  and coverage of existing health  data and  indicators 
at  the Community  level  and  at  the  level  of  Member  States  and  to  define  a  set  of  core  and 
background Community health indicators; providing support for the development of a network 
with agreed procedures and data specifications  necessary for  effective  and reliable exchange of 
information  using, as the principal means, an electronic network already under development as 
part of a wider Community project on interchange of data between administrations; and providing 
support for comparative analyses and reporting on health status and determinants and the impact 
of policies. 

4.2  Period covered and arrangements for renewal  or extension 

5 years: 01.01.1997 to 31.12.2001 
Report on implementation to be transmitted to the Council and European Parliament during 
the third year of the programme indicating the need for  any modifications,  if any. 
Report to the Council  and European Parliament  after  completion  of the programme with 
conclusions on renewal  or need for  extension  or revision of actions. 

5  CLASSIFICATION  OF EXPENDITURE  OR REVENUE 

Non-compulsory  expenditure 

Differentiated  appropriations 

6 TYPE OF EXPENDITURE OR REVENUE 

Subsidy for joint financing with other sources in the public and/or private sector (not exceeding 
a certain percentage of the total  cost of the proposed  projects). 

The level of funding granted depends on the scope of the measure to be financed and on the extent 
to which the action programme is reflected  in the various activities planned. 

Such funding will not exceed 70% of the total budget earmarked for the proposed projects except 
in the case of networks and work ordered and of direct use to the Commission, where the subsidy 
may amount to 100%. 

48 

7  FINANCIAL IMPACT 

7.1  Method of calculating the total cost of operation (definition  of unit cost) 

The method  of calculation  is the result of experience acquired  in previous activities  related  to 
health data and indicators such as the European  System of accidents at work statistics (ESAW) 
and projects under ENS-CARE. The specific cost estimates are based on the assumption that half 
of the activities to be undertaken under this programme will require  100 percent funding  while 
the other half will require 50 percent funding and that the activities to be undertaken will involve 
most or all Member  States. A total amount rounded off to ECU  13.8 million during the period 
1997-2001 is deemed  necessary  for  these activities.  The annual  allocations  will  be decided in 
accordance with the normal budgetary procedures. 

49 

7.2 

Itemized  breakdown  of  cost  (in  ECU  million) 

Objective 

Action  Area 

YEARS 

Community 
Health  Data  and 
Indicators 

Identification, 
review,  and  critical 
analysis  of  existing 
data  and  indicators 
and  assessment  of 
future  needs 

Creation  of  a  set  of 
Community  health 
indicators 

Development  of 
routine  collection  of 
comparable, 
progressively 
harmonised  data  in 
Member  States 
(including  data 
dictionaries, 
conversions  and 
harmonisation  of 
definition  and 
collection  methods 

Elaboration  of 
specific  surveys  and 
modules  or  agreed 
questions  in  existing 
surveys 

Cooperation  with 
international 
organizations 

Support  for  the 
development  of 
standardised  health 
resource  statistics 

1997 

1998 

1999 

2000 

2001 

TOTAL 
1997-
2001 

Indicative  programming 

0.7 

0.3 

0.1 

0.1 

0.1 

1.3 

0.2 

0.2 

0.3 

0.2 

0.1 

0.1 

0.9 

0.3 

0.4 

0.5 

0.5 

1.9 

0.1 

0.2 

0.4 

0.6 

0.7 

2.0 

0.1 

0.1 

0.1 

0.1 

0.1 

0.5 

0.1 

0.1 

0.1 

0.1 

0.4 

50 

0.7 

0.7 

0.8 

0.8 

0.8 

3.8 

0.2 

0.2 

0.2 

0.2 

0.2 

1.0 

0 

0.1 

0.2 

0.3 

0.4 

1.0 

0.1 

0/2 

0.2 

0.2 

0.3 

1.0 

network 
development 

Analysis  and 
reporting 

Development  of 
data  specifications 
and  procedures  to 
be  used  in 
networking, 
focusing  on 
Community-wide 
electronic 
interchange  of  data 

Development  of  a 
capacity  for 
analyses,  including 
methodologies  and 
tools 

Support  to  the 
analysis  and 
evaluation  of  the 
impact  of 
Community  actions 
and  programmes  in 
public  health 

Support  to  the 
production  and 
dissemination  of 
reports  and  other 
information  material 
on  health  status  and 
trends,  health 
determinants,  and 
the  impact  of  other 
policies 

TOTAL 

2.3 

2.5 

2.7 

3.0 

3.3 

13.8 

51 

7.3  Indicative schedule of appropriations (in ECU million) 

1997 

1998 

1999 

2000 

2001 

TOTAL 

Commitment 

2.3 

2.5 

2.7 

3.0 

3.3 

13.8 

appropriations 

Payment 

appropriations 

1997 

1998 

1999 

2000 

2001 

Subsequent  years 

1.15 

.0.81 

1.25 

0.34 

0.88 

1.35 

0.37 

0.95 

1.5 

0.4 

1.05 

0.45 

TOTAL 

2.3 

-

2.5 

2.7 

3.0 

• 

1.15 

2.06 

2.57 

2.82 

3.10 

2.10 

13.8 

1.65 

1.65 

3.3 

8 FRAUD PREVENTION MEASURES; RESULTS OF MEASURES TAKEN 

The grant application forms will require information  on the identity and nature of potential 
beneficiaries  so that their reliability  can be assessed  in advance. 

Fraud prevention  measures (checks, intermediate reports, final report) are included  in the 
agreements or contracts between the Commission and beneficiaries.  The Commission will 
check reports and ensure that work has been properly  carried out before  intermediate and 
final payments are made. 

In addition, spot checks are carried out by the Commission to verify  how funds have been 
used. Checks have already been carried  out in other public health budget lines in relation 
to the financial years  1991,  1992,  1993, and  1994 and have shown  their  effectiveness. 

52 

9  ELEMENTS OF COST-EFFECTIVENESS ANALYSIS 

9.1  Specific  and quantifiable  objectives; 

The Community measures aim at establishing a Community  health monitoring  system by 
the accomplishment of the following  specific  objectives: 

the  establishment  of a set of  Community  (core and background) health  indicators 
which can be used to monitor health in the Community, which can facilitate planning, 
monitoring and evaluation  of Community programmes and  actions, and which can 
provide  added  value to  Member  States'  own  health  information  systems  and  thus 
support the development  of national  health policies; 
the establishment of content specifications for a network for the purpose of collection 
and dissemination of the health data and indicators, mainly using telematics; 
the establishment of a capacity to undertake analyses, and support to the preparation 
and dissemination of reports on health status, trends and determinants and the impact 
of policies. 

Target Population 

1.  Competent health authorities of the Member States, at national, regional and local level 

and competent international  organisations; 

2.  Health professionals, health epidemiological and/Statistical services, health and medical 
associations, academic institutions, especially schools of public health (especially for 
the first and third  objectives); 

3.  NGO's and other bodies interested in health matters, and the public in general (third 

objective). 

9.2  Grounds  for the operation 

Health information is specifically  mentioned in Article 129 as an area to which Community 
action  should  be directed.  The Council  (Resolution  of the Council  and the Ministers  for 
Health meeting within the Council of 27 May  1993 on future  action in the field of public 
health, OJ No C 174, 25.6.1993 p.l; Council Resolution of 2 June 1994 on the  framework 
for action in the field of public health OJ No CI 65,17.6.1994, p. 1), the European Parliament 
(Report and Resolution  of the European  Parliament  on public health  after  Maastricht  OJ 
No  C 329, 6.12.93, p.375),  and the  Commission  (Communication  on the framework  for 
action in the field of public health, COM (93) 559final of 23.11.93), have identified  health 
data and indicators as a fundamental  instrument in the Community policy-making process 
and  an invaluable tool  in  supporting Member  States' policies, and as an essential  part  of 
a health monitoring system which will serve to monitor health and health determinants, and 
permit comparisons to be made and facilitate the planning, monitoring and implementation 
of actions. 

The proposed 5-year programme is to develop such a health monitoring system to support 
the Community  and the Member  States in health policy-making and evaluation, to permit 
Member  States  to  carry  out  meaningful  comparisons  and  to  assist  them  in  allocating 

53 

resources to the various problem  areas more effectively.  In accordance with the principle 
of subsidiarity, such a system would have to be developed at Community level since it only 
can serve the needs of the Member States both with regard to information in support of their 
national policies and with regard to their role in Community policy-making. In view of the 
scale of the operation  involved,  i.e. comparable health  data and common  indicators, and 
network creation and development  linking competent authorities in all Member States, the 
pertinent activities can only take place at Community level. 

As regards the intervention methods and the allocation  of funds, the following  will apply: 

specific  application of the principle of subsidiarity when identifying  measures to be 
undertaken  and  co-financed; 
identification  and  selection  of  projects  for  co-financing  in  the  fields  of  health 
monitoring. These projects will be selected and implemented, where necessary, with 
the  assistance  of  national  coordinating  committees  that  may  be  established  in  the 
Member  States, with participation of persons and bodies involved in the production 
and use of health data and indicators; 
the concept of added Community value, which will continue to be realised in particular 
through the coordination of national measures, the dissemination of information  and 
experiences,  the  establishment  of  priorities,  the  development  of  networking  as 
appropriate,  selection  of European  projects  and the motivation  and  mobilisation  of 
all involved. 
Two  methods  will  be  employed  to  implement  the  programme.  One  is  to  support 
projects carried out in Member  States and at the Community level. The selection of 
priority  projects  is  based  largely  on  general  and  intermediate  objectives,  and 
implementation of the measures themselves depends on the quality and  effectiveness 
of projects submitted to the competent department during the course of the year. The 
other  is to  undertake  specific  activities  necessary  to  achieve  the  objectives  of  the 
programme, which will be fully  financed  by the programme. 

The selection  criteria for  projects  are as follows: 

Compatibility with the objectives and conformity  with at least one of the established 
objectives; 
Examination  of  the  "added  Community  value"  of  the  projects  (transnational 
participation, development of a model applicable in other Member States, information 
usable in other Member  States, etc.); 
Presumed  effectiveness  and  profitability; 
Clarity and justification  of requirements; 
Relevance of selected methodology; 
Organizational  competence and experience; 
Suitability  of budget for  objectives; 
Support for  projects  from  national partners; 
Objective  assessment; 
Opinion  of the advisory  committee involved; 

54 

9.3  Monitoring and evaluation of the operation 

9.3.1  Monitoring of the operation 

Monitoring  at the Community level  is to be carried out by the Commission, which 
will  submit a report half-way  through the implementation  of the programme, and a 
final  report after its completion to the Council, the European Parliament, the Economic 
and  Social  Committee,  and the Committee  of  the Regions,  drawing  from  national 
reports as well as evaluations of the actions under the programme and of individuals 
projects. 

9.3.2  Evaluation 

Evaluation will be by means  of: 

An evaluation of the main measures and of subsidised proj ects involving, where 
necessary, the participation  of indépendant experts; 
An overall report on the quality and effectiveness of projects implemented under 
the action plan, to be submitted by the Commission to the other Community 
institutions after  completion of the programme. 

Performance  indicators selected for this evaluation: 

Evaluation of projects by Commission officials  and/or those cooperating with 
them; 
Analysis of intermediate reports on measures scheduled and financed, allowing 
a shifting  of emphasis where possible; 
Impact  studies by external bodies 
Relevance of the methodology  used by organizers; 
Suitability  of the budget for the objectives; 
Skills and experience of bodies; 
Dissemination  of results; 

Evaluation  procedures and intervals: 

Drawing up of intermediate and final reports on the various measures undertaken 
in the field; 
Development of a "standard" evaluation form for the measure, to be forwarded 
by the beneficiaries  with their final reports, and checking of these documents 
by officials  either at the Commission  or in the  field. 

10 

ADMINISTRATIVE  EXPENDITURE (PART A OF THE BUDGET) 

Actual  mobilisation  of the necessary  administrative resources will  be conditioned by the 
Commission's annual  decision  on the allocation  of resources,  having regard  in  particular 
to additional  staff  and funds  provided by the budgetary  authority. 

55 

10.1  Impact on the number of employees 

Types  of  employees 

staff  carrying  out  action 

source  of  employee 

duration 

permanent 
employees 

temporary 
employees 

from  within 
DG  or  service 

supplemen 
tary  staff 

Officiais  or 
temporary 
agents 

A 
B 
C 

Other resources 

Total 

1 
1 
1 

3 

0 

0 

1 
1 
1 

3 

0 
0 
0 

0 

10.2  Financial  impact of supplementary  staff 

10.3  Increase in other running costs arising from  the action 

Budget line 

Amounts 

Method  of calculation 

Meetings A2510 

231,000 

*2 meetings of advisory  committee, 2 
reps./Member State 
2 x 30 x 770 ecu x  5 years 

The resources necessary to cover the expenditure below for the 5-year period will be obtained by re-deployment 
of existing financial resources and the use of supplementary  resources will  not be required. 

a) Personnel Expenses (Title Al,  A2 and A5) 

3 x  100,000 ecus x  5 years =  1,500,000 ecus 

b) Operational  Expenses 

Expenses for  meetings (A-250) 
2 meetings x  15 experts x 879 ecus x 5 years =  131,850 ecus 
Expenses for travel (A-130) 
24 missions Brussels-Luxembourg  x 5 years = 240,000 ecus 
60 missions to Member  States x 5 years = 300,000 ecus 

c) Total: 

2,171,850 ecus 

56 

ISSN 0254-1475 

COM(95) 449  final 

DOCUMENTS 

EN 

17  05 

Catalogue number  : CB-CO-95-490-EN-C 

ISBN 92-77-93851-X 

Office  for Official  Publications  of the European Communities 

L-2985 Luxembourg 

.try-