COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 11.11.1996 
COM(96) 581 final 
95/0238 (COD) 
OPINION OF THE COMMISSION 
pursuant to Article 189 b (2) (d) of the EC Treaty, 
on the European Parliament's amendments 
to the Council's common position regarding 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 field of public health 
(1997-2001) 
AMENDING THE PROPOSAL OF THE COMMISSION 
pursuant to Article 189 a (2) of the EC Treaty 

The entry into force of the Treaty of the European Union conferred upon the Community 
particular competence with regard to public health. In order to attain the health protection 
objectives set out in Articles 3(o) and 129 of the Treaty establishing the European 
Community, the Commission set out in its Communication COM(93)559 final a framework 
for action in the field of public health. 
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. 
The Commission has therefore proposed a programme of Community action on health 
monitoring1 with the aim to contribute to the development of a high-quality, policy-oriented 
health monitoring system for the European Community. This aim is intended to be achieved 
1) by establishing a set of health indicators, 2) by developing a network for the collection and 
dissemination of the data needed for the indicators; and 3) by developing the capacity to 
undertake analyses of the data. 
The Economic and Social Committee (ECOSOC) adopted its opinion on 27 March 19962. 
In general, the opinion is very favourable towards the proposed health monitoring programme. 
The ECOSOC warmly welcomes and endorses it, emphasising the importance of establishing 
and maintaining health indicators. It stresses the Commission's cooperation with the World 
Health Organization, the Organization for Economic Cooperation and Development, and the 
European Monitoring Centre for Drugs and Drug Addiction. 
The ECOSOC proposes that the proposed list of domains and headings for potential health 
indicators, which appear in Annex A of the Communication which accompanies the proposal, 
be annexed to the latter. Finally, it draws attention to the size of the appropriations of the 
programme which it feels should be increased because of the importance of the subject matter. 
1 OJ No. C 338/4, 16/12/1995; COM(95)449 final 
2 OJ No. C 174/3, 17/6/1996, p. 3 
The Committee of the Regions (COR) adopted its opinion on 18 January \9963. 
The COR has no objections to the general objectives of the proposed programme, but it insists 
that the COR and the local and regional authorities be given a significant role in the 
implementation of the programme. It also notes that the programme could be used for setting 
up minimum standards of health in all Member States in the future. 
The COR is concerned that the budget is too low to permit the cooperation that will be needed 
with other agencies, local and regional authorities, etc. 
The COR proposes to reduce the proposed Committee to one (1) representative per Member 
State instead of the proposed two (2) representatives per Member States. In addition, it would 
like to have additional Committee members drawn from regional bodies such as the COR, the 
NOMESKO (the Nordic Committee for Medical Statistics) and others. 
The European Parliament adopted its opinion following the first reading on 17 April 19964, 
containing 44 amendments to the original Commission proposal. The amendments adopted are 
intended to modify or supplement the proposal for a Decision on a number of points: 
the implementation arrangements for the programme: comitology and budget; 
general aspects relating to the scope of the programme (including the establishment of 
a European Health Observatory, and the setting of health targets by Member States); 
further information on certain measures, through rewording or additions to the text, 
including an Annex (II), containing a list of potential domains in which the health 
indicators may be established. 
The Commission accepted 28 amendments of the 44 proposed by the Parliament, either in full 
or in part. 
On 13 May 1996 the Commission adopted an amended proposal taking account of the 
aforementioned Parliament amendments5, 
On 14 May 1996 the Council unanimously adopted a common position with a view to 
adopting the Decision in question. 
The Commission was unable to accept this common position and expressed reservations 
concerning the following points: 
3 OJ No. C 129/50, 2/5/1996, p. 50 
4 Doc. PE 215.742/fin. 
5 Com(96) 222 final 
Article 3 (Budget): The common position adopted by the Council makes provisions 
for a budget of 13 MECU for the programme over a period of five years between 1 
January 1997 and 31 December 2001. In its proposal, the Commission had proposed 
a total of 13.8 MECU for the period 1997-2001. The Commission considers that its 
proposal respects the ceilings under Rubric 3 of the Financial Perspective and is 
relatively modest given the scale of the new programme and its importance. The 
Commission has therefore askçd that a statement be inserted in the Council minutes 
reserving its position on the budget, which it considers insufficient. 
Article 5 (Comitology): The Council wants to introduce a "mixed" comitology 
procedure for the implementation of the programme. Under this procedure, which is 
similar to that set up for the other public health programmes (AIDS, Cancer, and 
Health Promotion), there would be 9 matters which fall under the Committee's 
"management" competence, and others falling within its "advisory" competence. The 
Commission has entered a reservation concerning this approach, which it finds overly 
bureaucratic and onerous, preferring a purely advisory committee which could cover 
explicitly, but not limited to, some of the areas of activity envisaged by the Council. 
Article 7(3) (Evaluation): The Council wanted the Commission to make proposals 
concerning the continuation of the programme. The Commission regrets the reference 
to evaluations forming the basis for making recommendations concerning the 
continuation of the programme, as this may not be desirable or appropriate in relation 
to the right of initiative of the Commission. Accordingly, the Commission has entered 
a reservation on Article 7(3) into the Council minutes. 
Recital 26, Article 5(g), Annex I (objective A and action A.3): The Commission 
regrets the deletion of the words "progressively harmonised data" in recital 26, and the 
reference to making data merely "comparable" rather than "progressively harmonised" 
in Art. 5(g), and objective A and action A.3 of Annex I, and, in view of the second-
reading of the European Parliament, reserves its position on this matter. A reservation 
on this matter has been entered into the Council minutes. 
Furthermore, the Council did not adopt most of the amendments proposed by European 
Parliament which the Commission had introduced in its amended proposal: Given the 
importance attached by Parliament to these amendments, the Commission could only express 
its reservation at their non-inclusion in the Council's common position and made a statement 
to be entered in the minutes to this effect. 
On 23 October 1996 the European Parliament6, adopted 19 amendments to the Council 
common position. The Commission's opinion concerning each of these amendments is given 
in the Annex. 
The Commission points out that in accordance with Article 189b(3) of the Treaty if, within 
three months of receiving the Parliament amendments, the Council, acting by a qualified 
majority, approves all of the amendments, it shall amend its common position accordingly an--. 
adopt the act in question; however, the Council shall act unanimously on the amendments on 
which the Commission has delivered a negative opinion. If the Council does not approve the 
act in question, the President of the Council, in agreement with the President of the European 
Parliament, shall forthwith convene a meeting of the Conciliation Committee. 
Doc. PE 218.544/fin. 
4/b 
ANNEX7 
Amendment 1: Commission opinion: partially accepted. 
The Commission can only accept this amendment partially because a recital should 
refer to a legal text (e.g., resolution, conclusion, recommendation) and not to "a 
conciliation meeting". 
Amendment 2: Commission opinion: partially accepted. 
The Commission can only accept this amendment partially because the word 
"comparable" results in limiting the data to be collected by the system to only those 
which are comparable. This is not desirable as most data currently are not comparable. 
We should not await the production by Member States of Comparable data in order 
to develop health indicators. Furthermore, it is important to emphasise that the system 
includes the collection of health data. Finally, the network may already be in existence 
and need therefore not be established anew. 
Amendments 3: Commission opinion: rejected 
Support for Member States specific activities is outside the scope of the health 
monitoring programme. Furthermore, the subsidiarity principle would indicate that 
establishment and improvement of Member State databases is the purview of Member 
States. 
Amendment 4: Commission opinion: rejected. 
The Commission rejected this amendment because this is an important recital. There 
are no apparent reasons for its deletion. 
Amendments 5: Commission opinion: rejected. 
Text should be aligned to the wording of Article 129. 
Amendment 6: Commission opinion: partially accepted. 
The Commission can only accept this amendment partially because not all data will 
require joint development of definitions, etc. It is therefore misleading to use this 
wording. Furthermore, as currently worded, the amendment does not make sense. 
Amendments 7: Commission opinion: accepted. 
The wording of this amendment is that of the original Commission proposal. 
Amendment 8: Commission opinion: .rejected. 
The margin contained in Rubric 3 of the budget, under which this programme falls, 
does not allow for such an increase. 
The numbering of the amendments corresponds to the numbering of the Recommendation for second 
reading - Doc. PE 218.544/fin. 
Amendment 9: Commission opinion: accepted. 
The Commission can fully accept this amendment because the wording is consistent 
with that of the three other public health programmes as agreed in the conciliation 
meeting in December 1996. 
Amendment 10: Commission opinion: partially accepted. 
Part 1 is accepted only partially because the exact formulation contained in the 
comitology decision of 1987 should be followed. The Committee representation should 
be analogous to that of the other health programmes (which have 2 representatives per 
Member States). Part 2-4 are fully accepted because the wording is that of the original 
Commission proposal. 
Amendments 11: Commission opinion: rejected. 
The text should be aligned to the wording of Article 129, which does not impose any 
legal obligation to cooperate with non-governmental organisations. 
Amendment 12: Commission opinion: rejected. 
This amendment is rejected because the dates for the duration of the programme 
depend on its adoption. It is therefore inappropriate to specify the specific dates for the 
interim and final reports because they may not end up corresponding to the half-way 
point and the end of the programme, respectively. 
Amendments 13: Commission opinion: accepted. 
The wording is that of the original Commission proposal. 
Amendment 14: Commission opinion: rejected. 
This amendment is rejected because the first part of the amendment limits the routine 
collection of data to comparable data, which is too restrictive, as it prevents supporting 
the activities necessary to improve the comparability of the data. The second part 
implies an obligation to harmonise national data which may require harmonisation of 
legal provisions something which cannot be done under Article 129. 
Amendments 15: Commission opinion: rejected. 
Support for Member States specific activities is outside the scope of the health 
monitoring programme. Furthermore, the subsidiarity principle would indicate that 
establishment and improvement of Member State databases is the purview of Member 
States. Finally, this programme is not an instrument for disbursing funds to the 
Member States. Such action would not correspond to any objective, nor would it 
provide any added value. 
Amendment 16: Commission opinion: partially accepted. 
It is not the Commission which always undertakes such activities directly. However, 
it will seek to ensure that these activities are initiated as well as supported. 
Amendments 17: Commission opinion: accepted. 
The wording is that of the Commission's amended proposal. 
Amendment 18: Commission opinion: partially accepted. 
Analyses are contained in reports. Information materials are important even if they 
may not be reports or contain analyses. Furthermore, health systems are considered 
part of the determinants of health, and cost-effectiveness analysis of health systems is 
outside the scope of the programme. 
Amendment 19: Commission opinion: accepted. 
It is appropriate to support wide dissemination of reports and information materials 
prepared under the programme. 
AMENDED 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 
(1997-2001) 
(presented by the Commission pursuant to Article 189 a (2) 
of the EC-Treaty) 
Council Common Position Amended Proposal 
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 
Commission (1), 
Having regard to the Opinion of the Economic 
and Social Committee (2), 
Having regard to the Opinion of the Committee of 
the Regions (3), 
Acting in accordance with the procedure referred 
to in Article 189b of the Treatv, 
(l)OJN° C 338, 16.12.1995. p. 4 
(2) OJNo C 174. 17.6.1996, p. 3 
(3)OJN° C 129. 2.5.1996, p. 50 
10 
Council Common Position Amended Proposal 
1. Whereas, pursuant to Article 3 (o) of the 
Treaty, Community action must include a 
contribution towards the attainment of a high level 
of health protection; whereas Article 129 of the 
Treaty expressly provides for Community 
competence in this field insofar as die Community 
contributes to it by encouraging cooperation 
between the Member States and, if necessary, by 
lending support to their action; 
2. Whereas the Council, in its resolution of 
27 May 1993 on future action in the field of 
public health (1), considered that improved 
collection, analysis and distribution of health data, 
as well as an improvement in the quality and 
comparability of available data, are essential for 
the preparation of future programmes; 
3. Whereas the European Parliament, in its 
Resolution on public health policy after Maastricht 
(2), 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 with a view to 
analysing the effects of public health policies on 
health status in the Community; 
4. Whereas the Commission, in its communication 
of 24 November 1993 on the framework for 
action in the field of public health, identified 
increased cooperation on standardization and 
collection of comparable/compatible data on 
health, and the promotion of systems of health 
monitoring and surveillance as a prerequisite for 
the establishment of a framework for supporting 
Member States' policies and programmes; whereas 
the area of health monitoring, including health 
data and indicators, has been identified as a 
priority area for proposals on multiannual 
Community programmes in the field of public 
health; 
(l)OJN°C 174, 25.6.1993, p. 1 
(2) OJ N° C 329, 6.12.1993, p. 375 1. Whereas, pursuant to Article 3 (o) of the Treaty, 
Community action must include a contribution of 
the Community towards the attainment of a high 
level of health protection; whereas Article 129 
expressly provides for Community competence in 
this field, by encouraging cooperation between 
Member States and, if necessary, by supporting 
their action through promoting coordination of their 
policies and programmes in this field and 
encouraging cooperation with non-member 
countries and the relevant international 
organisations. 
3. Whereas the European Parliament, in its report 
on public health policy after Maastricht, 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 on 
health: 
11 
Council Common Position Amended Proposal 
5. Whereas in its Resolution of 2 June 1994 on 
the framework for action in the field of 
Community health (1), 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, estimates 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, on the basis in particular of 
knowledge of data relating to public health in 
Europe obtained by setting up a Community 
health monitoring system, it will be possible to 
monitor public health trends and define public 
health priorities and objectives; 
8. Whereas health monitoring, for the purposes of 
this Decision, encompasses the establishment of 
Community health indicators and the collection, 
dissemination, and analysis of Community health 
data and indicators; 
9. Whereas in Decision 93/464/EEC of 22 July 
1993 on the framework programme for priority 
actions in the field of statistical information 1993 
to 1997 (2), the Council identified under the 
heading "Health and safety statistics" the analysis 
of mortality and morbidity by cause as one of the 
fields of priority actions under the sectoral 
programmes for social policy, economic and social 
cohesion and consumer protection; 
(1) OJN° C 165, 17.6.1994, p. 1 
(2) OJN° L 219, 28.8.1993, p. 1 
12 
Council Common Position Amended Proposal 
10. Whereas in Decision 94/913/EC of 
15 December 1994 adopting a specific programme 
of research and technological development, 
including demonstration, in the field of 
biomedicine and health (1994-1998) (1), the 
Council identified a specific research task of 
coordination and comparison of European health 
data, including nutritional data, from the various 
Member States; whereas this was taken up in the 
relevant research work programme; 
11. 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; 
12. Whereas, in order to give full effect to 
requirements and expectations in this area, a 
Commumty 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; 
13. Whereas available options and possibilities 
for developing the various parts of a Community 
health monitoring system, including those making 
existing provisions more stringent, should be 
carefully examined with respect to the desired 
performance, flexibility and the costs and benefits 
involved; whereas a flexible system is required 
which can incorporate features which are deemed 
valuable at present while adapting to new 
requirements and other priorities; whereas such a 
system should include the definition of sets of 
Community health indicators and the collection of 
the data necessary for the establishment of such 
indicators; 
14. Whereas Community health data and 
indicators should draw from existing European 
data and indicators, such as those held by Member 
States or transmitted by them to international 
organizations, so as to avoid unnecessary 
duplication of work; 
(1) OJ N° L 361, 31.12.1994, p. 40 12. Whereas, in order fully to meet requirements 
and expectations in this area, a Community health 
monitoring system should be set up, involving the 
establishment of health indicators and the 
collection of health data, a network for 
transmission and sharing of health data and 
indicators, and building capacity for analysis and 
dissemination of health information; 
13. Whereas available options and possibilities for 
developing the various parts of a Community 
health monitoring system, including that of 
enhancing existing capabilities and/or setting up 
an observatory, should be examined with respect 
to the desired performance, and the costs and 
benefits involved; and whereas a flexible system 
is required which can incorporate features which 
are valuable at present while adapting to new 
requirements or other priorities; 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 
Council Common Position Amended Proposal 
15. Whereas the situation with regard to the 
collection of data varies from one Member State 
to another, 
16. Whereas a Community health monitoring 
system would benefit from the establishment of a 
telematics network for the collection and 
distribution of Community health data and 
indicators; 
17. Whereas the Community health monitoring 
system should be capable of producing data for 
the preparation of regular reports on health status 
in the European Community, analyses of trends 
and health problems, and should help produce and 
disseminate health information; 
18. Whereas the setting up of a health-monitoring 
system at Community level necessarily 
presupposes compliance with provisions 
concerning the protection of data and the 
introduction of measures to guarantee their 
confidentiality, such as the provisions laid down in 
Directive 95/46/EC of the European Parliament 
and of the Council of 24 October 1995 on the 
protection of individuals with regard to the 
processing of personal data and on the free 
movement of such data (1) and in Council 
Regulation (Euratom, EEC) n° 1588/90 of 11 June 
1990 on the transmission of data subject to 
statistical confidentiality to the Statistical Office of 
the European Communities (2); 
19. Whereas a multiannual programme should be 
launched within 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; 
20. Whereas, in accordance with the principle of 
subsidiarity, action on matters not falling within 
the exclusive competence of the Community, such 
as action on health monitoring, must be 
undertaken by the Commumty only if, by reason 
of their scale or effects, it can be better achieved 
by the Community; 
(1) OJ N° L 281, 23.11.1995, p.TT 
(2) OJ N° L 151, 15.6.1990, p. 1; Regulation 
amended by the 1994 Act of accession. 16. Whereas the Community health monitoring 
system would benefit from being based on a 
network, the backbone of which relies on 
telematics, for the collection and distribution of 
Community health data and indicators; 
20. 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 if, by reason of their 
scale or effects, it may be better carried out at 
Community level; 
14 
Council Common Position Amended Proposal 
21. Whereas policies and programmes formulated 
and implemented at Commumty level, in particular 
those undertaken within 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 the 
projects on telematics applications in the health 
field under the Community's RTD Framework 
must be 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 telematics 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 
specialized European agencies, such as the 
European Monitoring Centre for Drugs and Drug 
Addiction (EMCDDA) and the European 
Environment Agency, should be taken into 
account; 
22. Whereas cooperation with the competent 
international organizations and with non-member 
countries should be strengthened; 
23. Whereas, from an operational point of view, 
the investments made in the past in terms both of 
the development of Community networks and of 
cooperation with international organizations 
competent in this field should be safeguarded and 
further developed; 
24. Whereas it is important that the Commission 
should ensure implementation of this programme 
in close cooperation with the Member States. 22. Whereas cooperation in this area with the 
competent international organisations and with 
third countries should be fostered: 
15 
Council Common Position Amended Proposal 
25. Whereas a "modus vivendi" (1) between the 
European Parliament, the Council and the 
Commission concerning the implementing 
measures for acts adopted in accordance with the 
procedure laid down in Article 189b of the Treaty 
was concluded on 20 December 1994; 
26. Whereas data is insufficiently comparable at 
present and unnecessary duplication of effort 
should be avoided by the joint development of 
comparison and conversion methods, criteria and 
techniques, suitable 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; 
27.Whereas, in order to increase the value and 
impact of the action programme, a continuous 
assessment of the measures undertaken should be 
carried out, with particular regard to their 
effectiveness and the achievement of objectives at 
both national and Community level, and, where 
appropriate, the necessary adjustments should be 
made; 
28. Whereas this Decision lays down, for the 
entire duration of this 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 the Commission of 6 March 1995 (2) 
, for the budgetary authority during the annual 
budgetary procedure; 
29. Whereas this programme should run for five 
years in order to allow sufficient time for actions 
to be implemented to achieve the objectives set, 
(l)OJN°C 102. 4.4.1996, p. 1 
(2)OJN°C 102, 4.4.1996, p. 4 26. Whereas data are insufficiently comparable at 
present and there should be joint development of 
methodologies, comparison and conversion criteria 
and techniques, progressively harmonized data 
collection tools such as survey, questionnaires or 
parts thereof, and content specifications for health 
information to be shared using in particular a 
telematics network; 
16 
Council Common Position Amended Proposal 
HAVE DECIDED AS FOLLOWS: 
Article 1 
Establishment of the programme 
1. A programme of Community action on health 
monitoring, hereinafter referred to as "the 
programme", shall be adopted for the period 1 
January 1997 to 31 December 2001 within the 
framework for action in the field of public health. 
2. The objective of the programme shall be to 
contribute to the establishment of a Community 
health-monitoring system which helps to: 
(a) measure health status, trends and 
determinants throughout the Community, 
(b) facilitate the planning, monitoring and 
evaluation of Community programmes 
and actions and 
(c) provide Member States with appropriate 
high-quality health information to make 
comparisons and to support their national 
health policies 
by encouraging cooperation between Member States 
and, if necessary, by supporting their action through 
promoting coordination of their policies and 
programmes in this field and encouraging 
cooperation with non-member countries and the 
relevant international organisations. 
3. The actions to be implemented under the 
programme and their specific objectives are set 
out in Annex 1 under the following headings: 
A. Establishment of Community health indicators; 
B. Development of a Community-wide network 
for sharing health data; 
C. Analyses and reporting. 1. A programme of Community action on health 
monitoring, hereinafter refereed 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. 
17 
Council Common Position Amended Proposal 
A non-exhaustive list of areas in which health 
indicators could be established is set out in Annex 
II. 
Article 2 
Implementation 
1. The Commission shall ensure the 
implementation, in close cooperation with the 
Member States, of the actions set out in the Annex 
I in accordance with Article 5. 
2. The Commission shall cooperate with the 
institutions and organizations which are active in 
the field of health monitoring. 
Article 3 
Budget 
1. The financial framework for the implementation 
of the programme for the period referred to in 
Article 1 shall be ECU 13 million. 
2. The annual appropriations shall be authorized by 
the budgetary authority' within the limits of the 
financial perspective. 
Article 4 
Consistency and complementarity 
The Commission, with the assistance of 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, 
covering those that are situated in the context of 
public-health action as well as, in particular, the 
framework programme for statistical information, 
projects in the field of telematic interchange of data 
between administrations and the framework 
programme for research and technological 
development. in particular the telematics 
applications of the latter. 1. The financial resources for implementation of 
this programme for the period referred to in 
Article 1 shall be ECU H8 million. 
The Commission 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. 
18 
Council Common Position Amended Proposal 
Article 5 
Committee 
1. The Commission shall be assisted by a 
Committee, consisting of two members 
designated by each Member State and chaired by 
a representative of the Commission. 
2. The representative of the Commission shall 
submit to the Committee a draft of the measures 
to be taken concerning: 
(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 
the programme, including those involving 
cooperation with international 
organizations competent in the field of 
public health and participation of the 
countries referred to in Article 6 (2); 
(d) the evaluation procedure; 
(e) the arrangements for dissemination and 
transfer of results; 
(f) the arrangements for cooperating with the 
institutions and organizations referred to 
in Article 2 (2); 
(g) the provisions applicable to reporting the 
data conversion thereof and other 
methods for making the data comparable 
in order to achieve the objective referred 
to in Article 1(2); 
(h) the provisions for the definition and 
selection of indicators; 
(i) the provisions for the content specifications 
necessary for setting up and operation of 
the relevant networks; 1. The Commission shall be assisted by a 
committee of an advisory nature, hereinafter 
referred to as 'the Committee'. composed of two 
members per Member State and chaired by the 
representative of the Commission. 
2. The representative of the Commission shall 
submit to the Committee a draft of the measures 
to be taken concerning in particular : 
(a) the Committee's rules of procedure; 
(b) an annual work programme laying down 
the priorities for action; 
(c) arrangements, criteria and procedures for 
selecting and financing projects under the 
programme, including those involving co­
operation with international organizations 
competent in the field of public health and 
participation of the countries referred to in 
Article 6 (2); 
(d) the evaluation procedure; 
(e) the arrangements applicable to the 
reporting, conversion and harmonisation of 
data; 
(0 the arrangements for the definition and 
selection of indicators; 
(g) the arrangements for the content 
specifications necessary for the setting up 
and operation of the networks; 
Deleted 
Deleted 
19 
Council Common Position Amended Proposal 
The Committee shall deliver its opinion on the 
draft measures referred to above within a time 
limit which the Chairman may lay down according 
to the urgency of the matter. The opinion shall be 
delivered by the majority laid down in Article 
148 (2) of the Treaty in the case of decisions 
which the Council is required to adopt on a 
proposal from the Commission. The votes of the 
representatives of the Member States within the 
Committee shall be weighted in the manner set 
out in that Article. The Chairman shall not vote. 
The Commission shall adopt measures which shall 
apply immediately. However, if these measures are 
not in accordance with the opinion of the 
Committee, they shall be communicated by the 
Commission to the Council forthwith. In that event: 
the Commission shall defer application of 
the measures which it has decided upon 
for a period of two months from the date 
of such communication; 
the Council, acting by a qualified 
majority, may take a different decision 
within the time limit laid down in the 
first indent. 
3. In addition, the Commission may consult the 
Committee on any other matter concerning the 
implementation of this programme, including the 
arrangements for coordination with the other 
programmes and initiatives referred to Article 4. 
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 Chairman 
may lay down according to the urgency of the 
matter, if necessary by taking a vote. 
The opinion shall be recorded in the minutes; in 
addition, each Member State shall have the right 
to ask to have its opinion recorded in the minutes. Deleted 
Deleted 
3. In addition, the Commission may consult the 
Committee on any other matter concerning the 
implementation of the 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 Chairman 
may lay down according to the urgency of the 
matter, if necessary by taking a vote. 
The opinion shall be recorded in the minutes; in 
addition, each Member State shall have the right 
to ask to have its opinion recorded in the minutes 
20 
Council Common Position Amended Proposal 
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 of: 
financial assistance granted under the 
programme (amounts, duration, 
breakdown, and beneficiaries); 
Commission proposals or Community 
initiatives and the implementation of programmes in 
other areas which are of direct relevance to 
achievement of the objectives of the programme, 
with a view to ensuring the consistency and 
complementarity referred to in Article 4. 
Article 6 
International cooperation 
1. In the course of implementing the programme, 
cooperation with non-member countries and with 
international organizations competent in the field of 
public health, in particular the World Health 
Organization, the Organization for Economic 
Cooperation and Development and the International 
Labour Organization, shall be encouraged and 
implemented in accordance with the procedure laid 
down in Article 5. 
2. The programme shall be open to participation by 
the associated countries of Central and Eastern 
Europe (ACCEE), 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. The 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 European Free 
Trade Association (EFTA) countries, in accordance 
with procedures to be agreed with those countries. 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 of : 
financial assistance granted under the 
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. 
1. In the course of implementing this programme, 
cooperation with third 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. 
21 
Council Common Position Amended Proposal 
Article 7 
Monitoring and evaluation 
1. The Commission, 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. 
2. The Commission shall submit to the European 
Parliament and the Council an interim report 
halfway through the programme and a final report 
on completion thereof. The Commission shall 
incorporate into these reports information on 
Community financing in the various fields of 
action and on complementarity with the other 
programmes and initiatives referred to in 
Article 4, as well as the results of the evaluation 
referred to in paragraph 1. It shall also send the 
reports to the Economic and Social Committee 
and the Committee of the Regions. 
3. On the basis of the evaluations referred to in 
paragraph 1, the Commission may, if appropriate, 
make relevant proposals with a view to the 
continuation of this programme. 
Done at Brussels, 
For the European Parliament 
The President 
For the Council 
The President Deleted 
22 
Council Common Position Amended Proposal 
Annex I 
Specific Objectives and Actions 
A. ESTABLISHMENT OF COMMUNITY 
HEALTH INDICATORS 
Objective 
To establish Community health indicators by a 
critical review of existing health data and 
indicators and develop appropriate methods for the 
collection of health data and for making such data 
comparable, in accordance with the objective 
referred to Article 1 (2). 
1. Carrying out an identification, review and critical 
analysis of existing health indicators and data at 
European level and at Member State level taking as 
a basis data validated by the Member States in 
order to determine their relevance, quality and 
coverage with regard to the establishment of 
Community health indicators. 
2. Identification of a set of Community health 
indicators, including a subset of core indicators for 
the monitoring of Community programmes and 
actions in public health, and a subset of background 
indicators for the monitoring of other Community 
policies, programmes and actions, and for providing 
Member States with common measures for making 
comparisons. A non-exhaustive list of the areas in 
which health indicators could be established is set 
out in Annex II. 
3. Development of the routine collection data and 
of methods for making health data comparable, in 
order to achieve the objective referred to in Article 
1 (2), including support for the drawing up data 
dictionaries and the establishment of appropriate 
conversion methods and rules. 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 
harmonized health data, in accordance with the 
objective referred to in Article 1(2). 
2. Creation of a set of Community health 
indicators, including a sub-set of core indicators 
for the monitoring of Community programmes 
and 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. A non-
exhaustive list of the areas in which health 
indicators could be established is set out in 
Annex II. 
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. 
23 
Council Common Position Amended Proposal 
4. Contributing to the collection of comparable 
data by supporting the preparation of surveys, 
including Community-wide surveys in support of 
the framing of Community policies, or drawing up 
agreed specimen modules or questionnaires for use 
in existing surveys. 
5. Fostering cooperation with international 
organizations competent in the field of 
Community 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. Encouragement and support for the assessment 
of the feasibility and cost-effectiveness of 
developing standardized health-resource statistics 
with the aim of including them in a future 
Community health-monitoring system. 
B. DEVELOPMENT OF A COMMUNITY-WIDE 
NETWORK FOR SHARING HEALTH DATA 
Objective 
To enable the establishment of an effective and 
reliable system for the transfer and sharing of 
health data and indicators using telematic 
interchange of data as the principal means. 
7. Encouragement and support for the development 
of a network for transferring and sharing health 
data, mainly using telematic interchanges and a 
system of distributed databases, in particular by the 
establislunent of data specifications and of 
procedures with regard to access, retrieval, 
confidentiality and security for the different types 
of information to be included in the system. 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 of agreed forms 
of words for questions in existing surveys. 
5. Foster co-operation with international 
organization 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. 
6a.(new) Carrying out feasibility studies on the 
possibility of setting UP a permanent body (the 
European Observatory) responsible for monitoring 
and evaluation health data and indicators in the 
Community area. 
24 
Council Common Position Amended Proposal 
C. ANALYSES AND REPORTING 
Objective: 
To develop methods and tools necessary for 
analysis and reporting and to support analyses and 
reporting on health status, trends and determinants 
and on the effect of policies on health. 
8. Encouragement and support for the 
development of capacity for analyses by 
enhancing existing capabilities and for feasibility 
studies for possible new structures of 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 of the impact of 
Community actions and programmes in the field 
of public health, and for drawing up and 
disseminating reports evaluating such impact. 
10. Support for the preparation, production and 
dissemination of reports and other information 
material on health status and trends, health 
determinants and the impact on health of other 
policies. 8. Encouragement of and support for the 
development of a capacity for analyses, enhancing 
existing capabilities, and for feasibility studies for 
possible new structures, 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, preparation, and 
dissemination of reports evaluating the impact of 
Community action and programmes in the field of 
public health. 
10. Support for the drafting, preparation and 
production of reports and other information 
material on health status and trends, health 
determinants and the impact on health of other 
policies. 
10a. (new) Support for the dissemination of 
reports and information material to the Member 
States, international organizations, professionals 
and bodies in the health sector and the general 
public. 
25 
Council Common Position Amended Proposal 
Annex II 
Non-exhaustive list of areas in which health 
indicators may be established 
A. Health status 
1. Life expectancy: 
- life expectancy at certain ages, 
- health expectancies, 
2. Mortality: 
- overall, 
- causes of death, 
- diseases-specific survival rates, 
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. Alcohol consumption 
3. Illegal drug consumption 
4. Physical activities 
5. Diet 
6. Sex life 
7. Other Annex II 
Non-exhaustive list of areas in which health 
indicators may be established 
A. Health status 
1. Life expectancy: 
- life expectancy at certain ages, 
- health expectancies, 
2. Mortality: 
- overall, 
- causes of death, 
- diseases-specific survival rates, 
3. Morbidity: 
- disease-specific, 
morbidity, 
- co-morbidity, 
Functioning and quality of life: 
- self-perceived health, 
- physical disability, 
- activity limitations, 
- functional status/ability, 
- health-related work loss, 
- mental health. 
Anthropometric characteristics 
B. Life style and health habits 
1. Tobacco consumption 
2. Alcohol consumption 
3. Illegal drug consumption 
4. Physical activities 
5 Diet 
6. Sexual behaviour 
7. Other 
26 
Council Common Position Amended Proposal 
C. Living and working conditions 
1. Employment/unemployment: 
occupation. 
2. Work environment: 
accidents, 
exposure to carcinogenic and 
other dangerous substances, 
occupational diseases. 
3. Housing conditions 
4. Home and leisure activities: 
accidents at home, 
leisure. 
5. Transport: 
car 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 utilization. 
Health-care personnel. 
3. Cost/Expenditure: 
In-patient care. 
Out-patient care, 
Pharmaceutical products. C. Living and working conditions 
1. Employment/unemployment: 
occupation. 
2. Work environment: 
accidents, 
exposure to carcinogenic and 
other dangerous substances, 
occupational health. 
3. Housing conditions 
4. Home and leisure activities: 
accidents at home, 
leisure. 
5. Transport: 
car 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 utilization, 
Health-care personnel. 
3. Cost/Expenditure: 
In-patient care. 
Out-patient care. 
Pharmaceutical products. 
27 
Council Common Position Amended Proposal 
4. Consumption/uses: 
In-patient care, 
Out-patient care, 
Pharmaceutical products. 
5. Health promotion and disease prevention 
E. Demographic and other social factors 
1. Gender 
2. Age 
3. Marital status 
4. Region of residence 
5. Education 
6. Income 
7. Population subgroups 
8. Health insurance status 
F. Miscellaneous 
1. Product safety 
2. Others 4. Consumption/uses: 
In-patient care, 
Out-patient care, 
Pharmaceutical products. 
5. Health promotion and disease prevention 
E. Demographic and other social factors 
1. Gender 
2. Age 
3. Marital status 
4. Region of residence 
5. Education 
6. Income 
7. Population subgroups 
8. Health insurance status 
F. Miscellaneous 
1. Product safety 
2. Others 
28 



ISSNJ3254-1475 
C0M(96) 581 final 
DOCUMENTS 
EN 05 
Catalogue number : CB-CO-96-580-EN-C 
ISBN 92-78-11546-0 
Office for Official Publications of the European Communities 
L-2985 Luxembourg 
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