CELEX: 51996PC0581
Language: en
Date: 1996-11-11
Title: 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)

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
 ---pagebreak---  ---pagebreak---  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
 ---pagebreak---   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
 ---pagebreak---          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
 ---pagebreak---                                             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.
 ---pagebreak---  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.
 ---pagebreak--- 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.
 ---pagebreak---                     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)
 ---pagebreak---          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
 ---pagebreak---            Council Common Position                                    Amended Proposal
 1. Whereas, pursuant to Article 3 (o) of the           1. Whereas, pursuant to Article 3 (o) of the Treaty,
 Treaty, Community action must include a               Community action must include a contribution of
 contribution towards the attainment of a high level   the Community towards the attainment of a high
 of health protection; whereas Article 129 of the      level of health protection; whereas Article 129
 Treaty expressly provides for Community               expressly provides for Community competence in
 competence in this field insofar as die Community     this field, by encouraging cooperation between
 contributes to it by encouraging cooperation          Member States and, if necessary, by supporting
 between the Member States and, if necessary, by       their action through promoting coordination of their
 lending support to their action;                     policies and programmes in this field and
                                                      encouraging cooperation with non-member
                                                      countries and the relevant international
                                                      organisations.
 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            3. Whereas the European Parliament, in its report
Resolution on public health policy after Maastricht   on public health policy after Maastricht, has
(2), stressed the importance of having sufficient     stressed the importance of having sufficient and
and relevant information as a basis for the           relevant information as a basis for the
development of Community actions in the field of      development of Community actions in the field of
public health; whereas the European Parliament        public health; whereas the European Parliament
called on the Commission to collect and examine       called on the Commission to collect and examine
health data from Member States with a view to         health data from Member States and analyse
analysing the effects of public health policies on    trends and assess the effects of public health
health status in the Community;                       policies, as well as the impact of other policies on
                                                      health:
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
                                                        11
 ---pagebreak---            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
 ---pagebreak---           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          12. Whereas, in order fully to meet requirements
requirements and expectations in this area, a         and expectations in this area, a Community health
Commumty health monitoring system should be           monitoring system should be set up, involving the
developed, comprising the establishment of health     establishment of health indicators and the
indicators and the collection of health data, a       collection of health data, a network for
network for transmission and sharing of health        transmission and sharing of health data and
data and indicators, and a capacity for analysis      indicators, and building capacity for analysis and
and dissemination of health information;              dissemination of health information;
 13. Whereas available options and possibilities       13. Whereas available options and possibilities for
for developing the various parts of a Community       developing the various parts of a Community
health monitoring system, including those making      health monitoring system, including that of
existing provisions more stringent, should be         enhancing existing capabilities and/or setting up
carefully examined with respect to the desired        an observatory, should be examined with respect
performance, flexibility and the costs and benefits   to the desired performance, and the costs and
involved; whereas a flexible system is required       benefits involved; and whereas a flexible system
which can incorporate features which are deemed       is required which can incorporate features which
valuable at present while adapting to new             are valuable at present while adapting to new
requirements and other priorities; whereas such a     requirements or other priorities; whereas a
system should include the definition of sets of       Community health monitoring system should
Community health indicators and the collection of     include the definition of sets of Community health
the data necessary for the establishment of such      indicators and the collection of the data necessary
indicators;                                           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
                                                       13
 ---pagebreak---            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                16. Whereas the Community health monitoring
 system would benefit from the establishment of a        system would benefit from being based on a
 telematics network for the collection and               network, the backbone of which relies on
distribution of Community health data and                telematics, for the collection and distribution of
 indicators;                                             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         20. Whereas, in accordance with the principle of
subsidiarity, action on matters not falling within       subsidiarity, action on matters not under the
the exclusive competence of the Community, such          exclusive competence of the Community, such as
as action on health monitoring, must be                  action on health monitoring, must be undertaken
undertaken by the Commumty only if, by reason            by the Community only if, by reason of their
of their scale or effects, it can be better achieved     scale or effects, it may be better carried out at
by the Community;                                        Community level;
(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.
                                                          14
 ---pagebreak---             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            22. Whereas cooperation in this area with the
international organizations and with non-member       competent international organisations and with
countries should be strengthened;                     third countries should be fostered:
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.
                                                       15
 ---pagebreak---           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    26. Whereas data are insufficiently comparable at
present and unnecessary duplication of effort       present and there should be joint development of
should be avoided by the joint development of       methodologies, comparison and conversion criteria
comparison and conversion methods, criteria and     and techniques, progressively harmonized data
techniques, suitable data collection tools such as  collection tools such as survey, questionnaires or
surveys, questionnaires or parts thereof, and       parts thereof, and content specifications for health
content specifications for health information to be information to be shared using in particular a
shared using in particular a telematics network;    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
                                                     16
 ---pagebreak---            Council Common Position                                 Amended Proposal
 HAVE DECIDED AS FOLLOWS:
 Article 1
 Establishment of the programme
 1. A programme of Community action on health          1. A programme of Community action on health
 monitoring, hereinafter referred to as "the          monitoring, hereinafter refereed to as "this
 programme", shall be adopted for the period 1        programme", is hereby adopted for the period
 January 1997 to 31 December 2001 within the          1 January 1997 to 31 December 2001 within the
framework for action in the field of public health.   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.
                                                       17
 ---pagebreak---           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      1. The financial resources for implementation of
of the programme for the period referred to in         this programme for the period referred to in
Article 1 shall be ECU 13 million.                     Article 1 shall be ECU H 8 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             The Commission shall ensure that there is
Member States, shall ensure that there is              consistency and complementarity between actions
consistency and complementarity between actions        to be implemented under this programme and
to be implemented under this programme and other       other relevant Community programmes and
relevant Community programmes and initiatives,         initiatives, including the framework programme
covering those that are situated in the context of     for statistical information, the projects in the field
public-health action as well as, in particular, the    of telematic interchange of data between
framework programme for statistical information,       administrations, and the framework programme
projects in the field of telematic interchange of data for research and technological development and in
between administrations and the framework              particular the telematics applications of the latter.
programme for research and               technological
development. in particular the telematics
applications of the latter.
                                                         18
 ---pagebreak---             Council Common Position                                     Amended Proposal
 Article 5
 Committee
  1. The Commission shall be assisted by a               1. The Commission shall be assisted by a
 Committee, consisting of two members                    committee of an advisory nature, hereinafter
 designated by each Member State and chaired by          referred to as 'the Committee'. composed of two
 a representative of the Commission.                     members per Member State and chaired by the
                                                         representative of the Commission.
 2. The representative of the Commission shall          2. The representative of the Commission shall
 submit to the Committee a draft of the measures        submit to the Committee a draft of the measures
 to be taken concerning:                                to be taken concerning in particular :
 (a)       the Committee's rules of procedure;          (a)     the Committee's rules of procedure;
 (b)       an annual work programme indicating the      (b)     an annual work programme laying down
           priorities for action;                               the priorities for action;
c)         the arrangements, criteria, and procedures   (c)     arrangements, criteria and procedures for
          for selecting and financing projects under            selecting and financing projects under the
          the programme, including those involving              programme, including those involving co-
          cooperation with international                        operation with international organizations
          organizations competent in the field of               competent in the field of public health and
          public health and participation of the                participation of the countries referred to in
          countries referred to in Article 6 (2);               Article 6 (2);
(d)       the evaluation procedure;                     (d)     the evaluation procedure;
(e)       the arrangements for dissemination and        (e)     the arrangements applicable to the
          transfer of results;                                  reporting, conversion and harmonisation of
                                                                data;
(f)       the arrangements for cooperating with the     (0      the arrangements for the definition and
          institutions and organizations referred to            selection of indicators;
          in Article 2 (2);
(g)       the provisions applicable to reporting the    (g)     the arrangements for the content
          data conversion thereof and other                     specifications necessary for the setting up
          methods for making the data comparable                and operation of the networks;
          in order to achieve the objective referred
          to in Article 1(2);
(h)       the provisions for the definition and         Deleted
          selection of indicators;
  (i)     the provisions for the content specifications Deleted
          necessary for setting up and operation of
          the relevant networks;
                                                         19
 ---pagebreak---           Council Common Position                                 Amended Proposal
The Committee shall deliver its opinion on the      Deleted
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     Deleted
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      3. In addition, the Commission may consult the
Committee on any other matter concerning the        Committee on any other matter concerning the
implementation of this programme, including the     implementation of the programme.
arrangements for coordination with the other
programmes and initiatives referred to Article 4.
The representative of the Commission shall submit   The representative of the Commission shall submit
to the Committee a draft of the measures to be      to the Committee a draft of the measures to be
taken. The committee shall deliver its opinion on   taken. The committee shall deliver its opinion on
the draft within a time limit which the Chairman    the draft within a time limit which the Chairman
may lay down according to the urgency of the        may lay down according to the urgency of the
matter, if necessary by taking a vote.              matter, if necessary by taking a vote.
The opinion shall be recorded in the minutes; in    The opinion shall be recorded in the minutes; in
addition, each Member State shall have the right    addition, each Member State shall have the right
to ask to have its opinion recorded in the minutes. to ask to have its opinion recorded in the minutes
                                                     20
 ---pagebreak---            Council Common Position                                   Amended Proposal
 The Commission shall take the utmost account of      The Commission shall take the utmost account of
 the opinion delivered by the Committee. It shall     the opinion delivered by the Committee. It shall
 inform the Committee of the manner in which its      inform the Committee of the manner in which its
 opinion has been taken into account.                opinion has been taken into account.
 4. The representative of the Commission shall       4. Therepresentativeof the Commission shall
 keep the Committee regularly informed of:           keep the Committee regularly informed of :
           financial assistance granted under the             financial assistance granted under the
           programme (amounts, duration,                      programme (amounts, duration,
           breakdown, and beneficiaries);                     breakdown, and recipients:
           Commission proposals or Community                  Commission proposals or Community
 initiatives and the implementation of programmes in          initiatives and the implementation of
 other areas which are of direct relevance to                 programmes in other policy areas which
 achievement of the objectives of the programme,              are relevant to the achievement of the
with a view to ensuring the consistency and                   objectives of this programme, with a view
complementarity referred to in Article 4.                     to ensure the consistency and
                                                              complementarity required under Article 4.
 Article 6
International cooperation
 1. In the course of implementing the programme,     1. In the course of implementing this programme,
cooperation with non-member countries and with       cooperation with third countries and with
international organizations competent in thefieldof  international organisations competent in the field
public health, in particular the World Health        of public health, in particular the World Health
Organization, the Organization for Economic          Organization and the Organization for Economic
Cooperation and Development and the International    Cooperation and Development, shall be fostered
Labour Organization, shall be encouraged and         and implemented in accordance with Article 5.
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.
                                                      21
 ---pagebreak---           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 afinalreport
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   Deleted
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
                                                    22
 ---pagebreak---            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         To establish Community health indicators by a
critical review of existing health data and           critical review of existing health data and
indicators and develop appropriate methods for the    indicators, and develop appropriate methods for
collection of health data and for making such data    the collection of comparable and progressively
comparable, in accordance with the objective          harmonized health data, in accordance with the
referred to Article 1 (2).                            objective referred to in Article 1(2).
 1. Carrying out an identification,reviewand 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        2. Creation of a set of Community health
indicators, including a subset of core indicators for indicators, including a sub-set of core indicators
the monitoring of Community programmes and            for the monitoring of Community programmes
actions in public health, and a subset of background  and actions in public health, and a sub-set of
indicators for the monitoring of other Community      background indicators for the monitoring of other
policies, programmes and actions, and for providing   Community policies programmes and actions, and
Member States with common measures for making         for providing Member States with common
comparisons. A non-exhaustive list of the areas in    measures for making comparisons. A non-
which health indicators could be established is set   exhaustive list of the areas in which health
out in Annex II.                                      indicators could be established is set out in
                                                      Annex II.
3. Development of the routine collection data and     3. Development of the routine collection of
of methods for making health data comparable, in      comparable and/or progressively harmonised data
order to achieve the objective referred to in Article in the Member States, including support for the
1 (2), including support for the drawing up data      elaboration of data dictionaries, and the
dictionaries and the establishment of appropriate     establishment of appropriate conversion methods
conversion methods and rules.                         and rules.
                                                       23
 ---pagebreak---           Council Common Position                                   Amended Proposal
4. Contributing to the collection of comparable       4. Contributing to the collection of comparable
data by supporting the preparation of surveys,        data by supporting the elaboration of surveys
including Community-wide surveys in support of        including Community-wide surveys in support of
the framing of Community policies, or drawing up      Community policies, or modules of agreed forms
agreed specimen modules or questionnaires for use     of words for questions in existing surveys.
in existing surveys.
5. Fostering cooperation with international           5. Foster co-operation with international
organizations competent in the field of               organization competent in the field of European
Community health data and indicators and              health data and indicators and networks for the
networks for the exchange of health data covering     exchange of health data covering specific areas in
specific areas in public health, in order to enhance  public health, in order to enhance comparability of
comparability of data.                                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.
                                                      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.
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.
                                                       24
 ---pagebreak---           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                8. Encouragement of and support for the
development of capacity for analyses by             development of a capacity for analyses, enhancing
enhancing existing capabilities and for feasibility existing capabilities, and for feasibility studies for
studies for possible new structures of comparative  possible new structures, comparative and
and predictive methodologies and tools, the testing predictive methodologies and tools, the testing of
of hypotheses and models and the evaluation of      hypotheses and models and the evaluation of
health scenarios and outcomes.                      health scenarios and outcomes.
9. Support for the analysis of the impact of        9. Support for the analysis, preparation, and
Community actions and programmes in the field       dissemination of reports evaluating the impact of
of public health, and for drawing up and            Community action and programmes in the field of
disseminating reports evaluating such impact.       public health.
10. Support for the preparation, production and     10. Support for the drafting, preparation and
dissemination of reports and other information      production of reports and other information
material on health status and trends, health        material on health status and trends, health
determinants and the impact on health of other      determinants and the impact on health of other
policies.                                           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
 ---pagebreak---          Council Common Position                                    Amended Proposal
Annex II                                              Annex II
Non-exhaustive list of areas in which health          Non-exhaustive list of areas in which health
indicators may be established                         indicators may be established
A. Health status                                      A. Health status
         1.     Life expectancy:                               1.     Life expectancy:
                  - life expectancy at certain ages,                    - life expectancy at certain ages,
                  - health expectancies,                                - health expectancies,
         2.     Mortality:                                     2.     Mortality:
                  - overall,                                            - overall,
                  - causes of death,                                    - causes of death,
                  - diseases-specific survival rates,                   - diseases-specific survival rates,
         3.     Morbidity:                                     3.     Morbidity:
                  - disease-specific,                                   - disease-specific,
                     morbidity,                                            morbidity,
                  - co-morbidity,                                       - co-morbidity,
         4.     Functioning and quality of life:                      Functioning and quality of life:
                  - self-perceived health,                              - self-perceived health,
                  - physical disability,                                - physical disability,
                  - activity limitations,                               - activity limitations,
                  - functional status/ability,                          - functional status/ability,
                  - health-related work loss,                           - health-related work loss,
                  - mental health.                                      - mental health.
         5.     Anthropometric characteristics                        Anthropometric characteristics
B. Life style and health habits                       B. Life style and health habits
         1.       Tobacco consumption                          1.       Tobacco consumption
         2.       Alcohol consumption                          2.       Alcohol consumption
         3.       Illegal drug consumption                     3.       Illegal drug consumption
         4.       Physical activities                          4.       Physical activities
         5.       Diet                                         5        Diet
         6.       Sex life                                     6.       Sexual behaviour
         7.       Other                                        7.       Other
                                                       26
 ---pagebreak---          Council Common Position                             Amended Proposal
C. Living and working conditions                C. Living and working conditions
         1. Employment/unemployment:                     1. Employment/unemployment:
                   occupation.                                     occupation.
         2. Work environment:                            2. Work environment:
                   accidents,                                      accidents,
                   exposure to carcinogenic and                    exposure to carcinogenic and
                   other dangerous substances,                     other dangerous substances,
                   occupational diseases.                         occupational health.
         3. Housing conditions                          3. Housing conditions
        4. Home and leisure activities:                 4. Home and leisure activities:
                  accidents at home,                              accidents at home,
                   leisure.                                       leisure.
        5. Transport:                                   5. Transport:
                  car accidents.                                  car accidents.
        6. External environment:                        6. External environment:
                  air pollution,                                  air pollution,
                  water pollution,                                water pollution,
                  other types of pollution,                       other types of pollution,
                  radiation,                                      radiation,
                  exposure to carcinogenic and                    exposure to carcinogenic and
        other dangerous substances outside the          other dangerous substances outside the
        work environment.                               work environment.
D. Health protection                            D. Health protection
        1. Sources of financing                         1. Sources of financing
        2. Facilities/Manpower:                         2. Facilities/Manpower:
                  Health-resource utilization.                    Health-resource utilization,
                  Health-care personnel.                          Health-care personnel.
        3. Cost/Expenditure:                            3. Cost/Expenditure:
                  In-patient care.                                In-patient care.
                  Out-patient care,                               Out-patient care.
                  Pharmaceutical products.                        Pharmaceutical products.
                                                27
 ---pagebreak---          Council Common Position                             Amended Proposal
         4. Consumption/uses:                            4. Consumption/uses:
                 In-patient care,                                 In-patient care,
                 Out-patient care,                               Out-patient care,
                 Pharmaceutical products.                        Pharmaceutical products.
     5. Health promotion and disease prevention      5. Health promotion and disease prevention
E. Demographic and other social factors         E. Demographic and other social factors
         1.      Gender                                  1.      Gender
        2.       Age                                    2.       Age
        3.       Marital status                         3.       Marital status
        4.       Region of residence                    4.       Region of residence
        5.       Education                              5.       Education
        6.       Income                                 6.       Income
        7.       Population subgroups                   7.       Population subgroups
        8.       Health insurance status                8.       Health insurance status
F. Miscellaneous                                F. Miscellaneous
        1.       Product safety                         1.       Product safety
        2.       Others                                 2.       Others
                                                 28
 ---pagebreak---  ---pagebreak---  ---pagebreak---  ---pagebreak---                                                                   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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