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"B DECISION No 1400/97/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 30 June 1997
adopting a programme of Community action on health monitoring within the framework for action in the
field of public health (1997 to 2001)
(OJ L 193, 22.7.1997, p. 1)
Amended by:
Official Journal
No page date
"M1 Decision No 521/2001/EC of the European Parliament and of the
Council of 26 February 2001 L 79 1 17.3.2001
NB: This consolidated version contains references to the European unit of account and/or the ecu, which from 1 January 1999 should be
understood as references to the euro — Council Regulation (EEC) No 3308/80 (OJ L 345, 20.12.1980, p. 1) and Council Regulation(EC) No 1103/97 (OJ L 162, 19.6.1997, p. 1).1997D1400 — EN — 01.01.2001 — 001.001 — 1
DECISION No 1400/97/EC OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL
of 30 June 1997
adopting a programme of Community action on health monitoring within
the framework for action in the field of public health (1997 to 2001)
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 laid down in Article 189b of the
Treaty (4) in the light of the joint text approved by the Conciliation Committee
on 16 April 1997,
(1) Whereas, pursuant to Article 3 (o) of the Treaty, Community action
must include a contribution towards the attainment of a high level ofhealth protection; whereas Article 129 of the Treaty expressly provides
for Community competence in this field in so far as the Community
contributes to it by encouraging cooperation between the MemberStates 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 (
5), 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 thepreparation of future programmes;
(3) Whereas the European Parliament, in its resolution on public health
policy after Maastricht (
6), 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 Parliamentcalled on the Commission to collect and examine health data fromMember States with a view to analysing the effects of public health
policies on health status in the Community;
(4) Whereas it would be desirable to study the feasibility of establishing a
permanent structure for the monitoring and evaluation of European
Community health data and indicators;
(5) Whereas the Commission, in its communication of 24 November 1993
on the framework for action in the field of public health, regardedincreased cooperation on standardization and collection of com-
parable/compatible data on health, and the promotion of systems of
health monitoring and surveillance as a prerequisite for the establish-ment 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 proposalson multiannual Community programmes in the field of public health;
(6) Whereas in its resolution of 2 June 1994 on the framework for action in
the field of Community health (
7), the Council indicated that the
collection of health data should be accorded priority and invited the
Commission to present relevant proposals; whereas the Councilconsidered that data and indicators used should include measures!B
(1) OJ No C 338, 16. 12. 1995, p. 4, and
OJ No C 214, 24. 7. 1996, p. 6.
(2) OJ No C 174, 17. 6. 1996, p. 3.
(3) OJ No C 129, 2. 5. 1996, p. 50.
(4) Opinion of the European Parliament of 17 April 1996 (OJ No C 141, 13. 5. 1996, p.
94), Council Common Position of 18 June 1996 (OJ No C 220, 29. 7. 1996, p. 36)
and Decision of the European Parliament of 23 October 1996 (OJ No C 347, 18.11. 1996, p. 73). Decision of the Council of 5 June 1997 and Decision of the
European Parliament of 10 June 1997.
(
5) OJ No C 174, 25. 6. 1993, p. 1.
(6) OJ No C 329, 6. 12. 1993, p. 375.
(7) OJ No C 165, 17. 6. 1994, p. 1.1997D1400 — EN — 01.01.2001 — 001.001 — 2
relating to the quality of life of the population, accurate assessments of
health needs, estimates of the avoidable deaths from the prevention ofdiseases, socio-economic factors in health among different populationgroups, and, where appropriate and if the Member States judge it
necessary, health aid, medical practices, and the impact of reforms;
(7) Whereas health monitoring at Community level is essential for the
planning, monitoring and assessment of Community actions in thefield of public health, and the monitoring and assessment of the healthimpact of other Community policies;
(8) 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 trendsand define public health priorities and objectives;
(9) Whereas health monitoring, for the purposes of this Decision,
encompasses the establishment of Community health indicators andthe collection, dissemination and analysis of Community health data
and indicators;
(10) Whereas in Decision 93/464/EEC of 22 July 1993 on the framework
programme for priority actions in the field of statistical information1993 to 1997 (
1), 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;
(11) 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
to 1998) (
2), the Council identified a specific research task of
coordination and comparison of European health data, includingnutritional data, from the various Member States; whereas this wastaken up in the relevant research work programme;
(12) Whereas health monitoring at Community level s hould enable
measurements of health status, trends and determinants to be carried
out, facilitate the planning, monitoring and evaluation of Communityprogrammes and actions, and provide Member States with healthinformation supporting the development and evaluation of their health
policies;
(13) 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, the collection of thedata, in particular those needed ultimately to arrive at comparable
health indicators, the establishment of a network for transmission and
sharing of health data and indicators, and the development of acapacity for analysis and dissemination of health information;
(14) 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 thecosts and benefits involved; whereas a flexible system is requiredwhich 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 healthindicators and the collection of the data necessary for the establish-
ment of such indicators;
(15) Whereas Community health data and indicators should draw from
existing European data and indicators, such as those held by Member
States or forwarded by them to international organizations, so as toavoid unnecessary duplication of work;
(16) Whereas the situation with regard to the collection of data varies from
one Member State to another; whereas the Community may lend
support to Member States’ actions, including those related to data
collection in the context of a Community health monitoring system,when such support would provide Community added value;!B
(1) OJ No L 219, 28. 8. 1993, p. 1.
(2) OJ No L 361, 31. 12. 1994, p. 40.1997D1400 — EN — 01.01.2001 — 001.001 — 3
(17) Whereas a Community health monitoring system could benefit from
the establishment of a telematics network for the collection anddistribution of Community health data and indicators;
(18) Whereas the Community health monitoring system should be capable
of producing data for the preparation of regular reports on health status
in the Community and analyses of trends and health problems, and of
helping to produce and disseminate health information;
(19) Whereas the setting up of a health monitoring system at Community
level necessarily presupposes compliance with provisions concerningthe protection of data and the introduction of measures to guarantee the
confidentiality and security thereof, such as the provisions in Directive
95/46/EC of the European Parliament and of the Council of 24 October1995 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) No 1588/90 of 11 June 1990 on thetransmission of data subject to statistical confidentiality to theStatistical Office of the European Communities (
2);
(20) Whereas a multiannual programme must be launched within the
framework for action in the field of public health, in order to permit
the setting up of the future Community health monitoring system andof appropriate mechanisms for the evaluation thereof;
(21) 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
Community only if, by reason of their scale or effects, it can be betterachieved by the Community;
(22) Whereas policies and programmes formulated and implemented at
Community level, in particular those undertaken within the framework
for action in the field of public health, should be compatible with thetargets and objectives of Community action on health monitoring;whereas the implementation of Community actions on health monitor-
ing should take account of relevant research activities under the
Community’s framework programme for research and technologicaldevelopment; whereas projects on telematics applications in the healthfield under the Community’s RTD programme must be coordinated
with Community actions on health monitoring; whereas actions under
the Community’s framework programme for statistical information, theCommunity projects in the field of telematic interchange of databetween administrations (IDA) and G7 health-related projects must be
closely coordinated with the implementation of Community actions on
health monitoring; whereas the work undertaken by the specializedEuropean agencies, such as the European Monitoring Centre for Drugs
and Drug Addiction (EMCDDA) and the European Environment
Agency, should be taken into account;
(23) Whereas cooperation should be strengthened with the competent
international organizations, including the World Health Organization(WHO) and the Organization for Economic Cooperation and
Development (OECD), and with non-member countries; whereas
other bodies, such as non-governmental organizations, may also have arole to play;
(24) 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 developed;
(25) Whereas it is important that the Commission s hould ensure
implementation of this programme in close cooperation with the
Member States;
(26) Whereas a modus vivendi (
3) between the European Parliament, the
Council and the Commission concerning the implementing measuresfor acts adopted in accordance with the procedure laid down in Article189b of the Treaty was concluded on 20 December 1994;!B
(1) OJ No L 281, 23. 11. 1995, p. 31.
(2) OJ No L 151, 15. 6. 1990, p. 1. Regulation as amended by the 1994 Act of
Accession.
(3) OJ No C 102, 4. 4. 1996, p. 1.1997D1400 — EN — 01.01.2001 — 001.001 — 4
(27) Whereas data are insufficiently comparable at present and unnecessary
duplication of effort should be avoided by the joint development ofcomparison and conversion definitions, methods, criteria and tech-niques, by the development of suitable data collection tools such as
surveys, questionnaires or parts thereof, and by means of content
specifications for health information to be shared using in particular atelematics network;
(28) Whereas, in order to increase the value and impact of the action
programme, a continuous assessment of the measures undertakenshould 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;
(29) Whereas this Decision lays down, for the entire duration of this
programme, a financial framework constituting the principal point ofreference, within the meaning of point 1 of the declaration by the
European Parliament, the Council and the Commission of 6 March
1995 (
1), for the budgetary authority during the annual budgetary
procedure;
(30) Whereas this programme should run for five years in order to allow
sufficient time for actions to be implemented to achieve the objectivesset,
HA VE 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
"M131 December 2002 3within the framework for action in the field
of public health.
2. The objective of the programme shall be to contribute to the establish-
ment of a Community health monitoring system which makes it possible to:
(a) measure health status, trends and determinants throughout the Commu-
nity;
(b) facilitate the planning, monitoring and evaluation of Community
programmes and actions; and
(c) provide Member States with appropriate 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 andprogrammes in this field and encouraging cooperation with non-member
countries and the competent international organizations.
3. The actions to be implemented under the programme and their specific
objectives are set out in Annex I 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.
A non-exhaustive list of areas in which health indicators may 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 Annex I,
"M1in
accordance with the procedures laid down in Article 5a(2) and (3) 3.
2. The Commission shall cooperate with the institutions and organizations
which are active in the field of health monitoring.!B
(1) OJ No C 102, 4. 4. 1996, p. 4.1997D1400 — EN — 01.01.2001 — 001.001 — 5
Article 3
Budget
1. The financial framework for the implementation of the programme for
the period from 1 January 1997 to 31 December 2001 shall be EUR 13,8million and for the period from 1 January 2002 to 31 December 2002,
EUR 4,4 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 shall ensure that there is consistency and complementarity
between actions to be implemented under the programme and the otherrelevant Community programmes and initiatives, both those in the context of
public-health action and, in particular, the framework programme for
statistical information, projects in the field of telematic interchange of databetween administrations and the framework programme for research andtechnological development, in particular the telematics applications of the
latter.
Article 5
Implementing measures
The measures necessary for implementing this Decision, relating to the
matters referred to below shall be adopted in accordance with the
management procedure referred to in Article 5a(3):
(a) an annual work programme indicating the priorities for action;
(b) the arrangements, criteria and procedures for selecting and financing
projects under the programme, including those involving cooperation
with international organisations competent in the field of public health
and participation of the countries referred to in Article 6(2);
(c) the evaluation procedure;
(d) the provisions applicable to reporting of the data, conversion thereof and
other methods for making the data comparable in order to achieve the
objective referred to in Article 1(2);
(e) the arrangements for dissemination and transfer of results;
(f) the arrangments for cooperating with the institutions and organisations
referred to in Article 2(2);
(g) the provisions for the definition and selection of indicators;
(h) the provisions for the content specifications necessary for the setting up
and operation of the networks.
The necessary measures for the implementation of this Decision as regards
other matters shall be adopted in accordance with the advisory procedurereferred to in Article 5a(2).
Article 5a
Committee
1. The Commission shall be assisted by a Committee.
2. Where reference is made to this paragraph, Articles 3 and 7 of Decision
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3. Where reference is made to this paragraph, Articles 4 and 7 of Decision
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at
two months.
4. The Committee shall adopt its rules of procedure.!B
!M1
!B
!M11997D1400 — EN — 01.01.2001 — 001.001 — 6
Article 6
International cooperation
1. In the course of implementing the programme, cooperation with
non-member countries and with international organizations competent inthe field of public health, in particular the World Health Organization (WHO),
the Organization for Economic Cooperation and Development (OECD) and
the International Labour Organization (ILO), and with other organizationscompetent in the field of health monitoring shall be encouraged andimplemented
"M1in accordance with the procedures laid down in Article
5a(2) and (3) 3.
2. This programme shall be open to participation by the following countries:
(a) the EFTA/EEA countries in accordance with the conditions provided for
in the EEA Agreement;
(b) the associated countries of central and eastern Europe in accordance with
the conditions laid down in the Europe Agreements, the AdditionalProtocols to these Agreements and the decisions of the relevantAssociation Councils;
(c) Cyprus which shall be funded by additional appropriations, in accordance
with procedures to be agreed with this country;
(d) Malta and Turkey which shall be funded by additional appropriations in
accordance with the provisions of the Treaty.
Article 7
Monitoring and evaluation
1. The Commission, taking into account the reports drawn up 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 by 30 June 2000 and a final report on completion ofthe programme, and in any case not later than 30 June 2003. The Commission
shall incorporate into these reports information on Community financing in
the various fields of action and on complementarity with the otherprogrammes 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 tothe continuation of the programme.!B
!M1
!B1997D1400 — EN — 01.01.2001 — 001.001 — 7
ANNEX I
SPECIFIC OBJECTIVES AND ACTIONS
A. ESTABLISHMENT OF COMMUNITY HEALTH INDICA TORS
Objective
To establish comparable Community health indicators by means of a critical
review of existing health data and indicators, by developing methodologies forobtaining comparable health data and indicators, and by developing appropriatemethods for the collection of the progressively comparable health data neededto establish these indicators.
1. Identification, review and critical analysis of existing health indicators and
data at European level and at Member State level, taking as a basis datavalidated 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 andactions in public health and a subset of background indicators for themonitoring of other Community policies, programmes and actions, for
providing Member States with common measurements for making
comparisons. A non-exhaustive list of the areas in which health indicatorsmay be established is set out in Annex II.
3. Development of and support for the routine collection of health data to be
made comparable by the drawing up of data dictionaries, the establishment
of appropriate conversion methods and rules, and other methods to achieve
the objective referred to in Article 1 (2).
4. Contributing to the collection of comparable data by supporting the
preparation of surveys, including Community-wide surveys in support ofthe 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 fostering networks forthe exchange of health data covering specific areas in public health, inorder to enhance comparability of data.
6. Encouragement and support for the assessment of the feasibility and cost-
effectiveness of compiling standardized health resource statistics with theaim of including them in the Community health monitoring system to beestablished.
7. Support for continuation of the feasibility study in progress into the
possibility of establishing a permanent structure for the monitoring andevaluation of Community health data and indicators.
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 asthe principal means.
8. Encouragement and support for the establishment of a network for
transferring and sharing health data, mainly using telematic interchangesand a system of distributed databases, in particular by the establishment ofdata specifications and of procedures with regard to access, retrieval,
confidentiality and security for the different types of information to be
included in the system.
C. ANAL YSES 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 onthe effect of policies on health.
9. Encouragement and support for the development of capacity for analyses
by enhancing existing capabilities and for feasibility studies for possiblenew structures, comparative and predictive methodologies and tools, the!
B1997D1400 — EN — 01.01.2001 — 001.001 — 8
testing of hypotheses and models and the evaluation of health scenarios
and outcomes.
10. Support for the analysis of the impact of Community actions and
programmes in the field of public health, and for drawing up anddisseminating reports evaluating that impact.
11. Support for the preparation, drafting and dissemination of reports, analyses
and other information in order to help to make comparisons on the subject
of health status and trends, health determinants, and the effect of policieson health.!
B1997D1400 — EN — 01.01.2001 — 001.001 — 9
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,
— disease-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 consumption3. Illegal drug consumption
4. Physical activities
5. Diet6. Sex life7. Other
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,!
B1997D1400 — EN — 01.01.2001 — 001.001 — 10
— 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.
4. Consumption/uses:
— in-patient care,
— out-patient care,
— pharmaceutical products.
5. Health promotion and disease prevention.
E. Demographic and social factors
1. Gender
2. Age
3. Marital status4. Region of residence
5. Education
6. Income7. Population subgroups
8. Health insurance status
F. Miscellaneous
1. Product safety
2. Others!
B1997D1400 — EN — 01.01.2001 — 001.001 — 11