Proposal for a decision of the European Parliament and of the Council adopting a programme of Community action in the field of public health (2001-2006)
Date: 2000-06-15
Institutions: European Commission
Subjects: EU action, access to information, disease prevention, health policy, public health

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Proposal for a Decision of the European Parliament and of the Council adopting a programme of
Community action in the field of public health (2001-2006)

(2000/C 337 E/16)

(Text with EEA relevance)

COM(2000) 285 final (cid:15) 2000/0119(COD)

(Submitted by the Commission on 15 June 2000)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 152 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of
Committee,

the Economic and Social

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

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

Whereas:

9 Decision No 647/96/EC of the European Parliament
and of the Council of 29 March 1996 adopting a
programme of Community action on the prevention
of AIDS and certain other communicable diseases
within the framework for action in the field of
public health (1996 to 2000) (4);

9 Decision No 102/97/EC of the European Parliament
and of the Council of 16 December 1996 adopting a
programme of Community action on the prevention
of drug dependence within the framework for action
in the field of public health (1996 to 2000) (5);

9 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 moni-
toring within the framework for action in the field
of public health (1997 to 2001) (6);

disease,

committed to promoting

is
and
(1) The Community
reducing avoidable mortality and
improving health,
activity-impairing
and
disability, preventing
countering potential threats to health. The Community
must address in a coordinated and coherent way the
concerns of its people about risks to health and their
expectations for a high-level of health protection and,
therefore, all health-related activities of the Community
must have a high degree of visibility and transparency
and allow consultation and participation of all stake-
holders in a balanced way,
in order to promote better
knowledge and communication flows and thus enable a
larger involvement of individuals in decisions that concern
their health.

(2) In the context of the public health framework set out in
the Commission communication of 24 November 1993
on the framework for action in the field of public
health (1), eight action programmes were adopted, namely:

9 Decision No 645/96/EC of the European Parliament
and of the Council of 29 March 1996 adopting a
health
programme
promotion,
training
within the framework for action in the field of
public health (1996 to 2000) (2);

action
education and

of
information,

Community

on

9 Decision No 646/96/EC of the European Parliament
and of the Council of 29 March 1996 adopting an
action plan to combat cancer within the framework
for action in the field of public health (1996 to
2000) (3);

(1) COM(93) 559 final of 24 November 1993.
(2) OJ L 95, 16.4.1996, p. 1.
(3) OJ L 95, 16.4.1996, p. 9.

9 Decision No 372/1999/EC of the European Parliament
and of the Council of 8 February 1999 adopting a
injury
programme
prevention in the framework for action in the field
of public health (1999 to 2003) (7);

Community

action

on

of

9 Decision No

1295/1999/EC of

European
Parliament and of
the Council of 29 April 1999
adopting a programme of Community action on rare
diseases within the framework for action in the field of
public health (1999 to 2003) (8); and

the

9 Decision No

the

1296/1999/EC of

European
Parliament and of
the Council of 29 April 1999
adopting a programme of Community action on
the
pollution-related diseases
framework for action in the field of public health
(1999 to 2001) (9).

context of

in the

included

in the context of

the public health
(3) Other activities
the Council Recommendation
framework
98/463/EC 29 June 1998 (10) on the suitability of blood
and plasma donors and the screening of donated blood in
the European Community of Decision No 2119/98/EC of
the
the Council of
24 September 1998 setting up a network for the epidemi-

European Parliament

and of

(4) OJ L 95, 16.4.1996, p. 16.
(5) OJ L 19, 22.1.1997, p. 25.
(6) OJ L 193, 22.7.1997, p. 1.
(7) OJ L 46, 20.2.1999, p. 1.
(8) OJ L 155, 22.6.1999, p. 1.
(9) OJ L 155, 22.6.1999, p. 7.
(10) OJ L 203, 21.7.1998, p. 14.

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communicable
and control of
surveillance
ological
in the Community (1), and Recommendation
diseases
1999/519/EC on 12 July 1999 on the limitation of
exposure of the general public to electromagnetic fields
0 Hz to 300 GHz (2).

(4) The public health framework was

reviewed in the
Commission communication of 15 April 1998 on the
development of public health policy in the European
Community (3), which indicated that
a new health
strategy and programme were needed in view of
the
new Treaty provisions, new challenges and experience
so far.

(5) The Council in its conclusions of 26 November 1998 on
the future framework for Community action in the field of
public health (4), and in its Resolution of 8 June 1999 (5),
the Economic and Social Committee,
in its opinion of
9 September 1998 (6), the Committee of the Regions, in
its opinion of 19 November 1998 (7), and the European
in its Resolution A4-0082/99 of 12 March
Parliament,
1999 (8), welcomed the Commission communication of
15 April 1998 and supported the view that actions at
Community level
in one overall
should be set out
programme to run for a period of at least five years
and
namely
improving information for the development of public
health, reacting rapidly to health threats and tackling
health determinants
through health promotion and
disease prevention, underpinned by inter-sectoral action
and the use of all appropriate Treaty instruments.

comprising

objectives,

general

three

(6) The overall aim of the public health programme should
be to make a contribution towards the attainment of a
high level of health protection by directing action towards
improving public health, preventing human illness and
diseases, and obviating sources of danger
to health.
Action should be guided by the need to prevent
expectancy without
premature
and
disability or
the
physical
thus
economic and social consequences of
reducing health inequalities.

life
and minimise
ill health,

sickness, promote quality of

and mental well-being,

increase

death,

life

(7) Achieving this aim, and the general objectives of

the
programme
the
effective
Member States, their full commitment in the implemen-
tation of Community actions, and the involvement of
actors in the health field as well as the public at large.

cooperation

requires

of

(1) OJ L 268, 3.10.1998, p. 1.
(2) OJ L 199, 30.7.1999, p. 59.
(3) COM(98) 230 final.
(4) OJ C 390, 15.12.1998, p. 1.
(5) OJ C 200, 15.7.1999, p. 1.
(6) OJ C 407, 28.12.1998, p. 26.
(7) OJ C 51, 22.2.1999, p. 53.
(8) OJ C 175, 21.6.1999, p. 135.

in Article 5 of

(8) In accordance with the principles of subsidiarity and
proportionality set out
the Treaty,
Community action on matters which do not fall within
the exclusive competence of
the Community, such as
public health, should be undertaken only if and insofar
as, by reason of its scale or effects, its objective can be
better achieved by the Community. The objectives of the
programme cannot be sufficiently accomplished by the
Member States because of the complexity, transnational
character and lack of complete control at Member State
level over the factors affecting health status and health
systems. The programme will enable the Community to
contribute towards fulfilling its Treaty obligations in the
field of public health while fully respecting the responsi-
bilities of the Member States for the organisation and
delivery of health services and health care. This Decision
does not go beyond what is necessary to achieve those
objectives.

conditions

arising out of

(9) The measures under the programme underpin the health
strategy of
the Community and will yield Community
added value by responding to needs in health policy
and health systems
and
structures established through Community action in
other
fields, by addressing new developments, new
threats and new problems for which the Community
its
would be in a better position to act
people, by bringing together activities undertaken in
relative isolation and with limited impact at national
level and by complementing them in order to achieve
positive results for the people of the Community, and
by contributing to the strengthening of solidarity and
cohesion in the Community.

to protect

(10) In order to ensure that actions can address broad health
issues and threats effectively in cooperation with other
Community policies
the programme
should provide for the possibility of undertaking joint
actions with related Community programmes and actions.

activities

and

(11)

In the execution of the programme, full use should be
made of
the results generated from the Community
research programmes, which support research in areas
covered by the programme.

(12) The programme should last six years in order to allow
time to implement measures to achieve its

sufficient
objectives.

(13) It

is

that

essential

the Commission should ensure
implementation of the programme in close cooperation
in order to obtain
with the Member States. Moreover,
scientific
the Commission
advice,
should cooperate with high-level committees of scientific
experts.

information and

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to

actions

(14) Consistency and complementarity should be ensured
between
the
be
programme and those envisaged or implemented under
other policies and activities, in particular in the light of
the requirement to ensure a high level of human health
protection in the definition and implementation of all
Community policies and activities.

implemented

under

a

financial

(15) This Decision lays down, for the entire duration of the
framework constituting the
programme,
principal point of
reference, within the meaning of
point 33 of the interinstitutional agreement of 6 May
1999 between the European Parliament, the Council and
and
the
the
improvement of
budgetary
budgetary
procedure.

budgetary
the budgetary procedure (1),
the

Commission

discipline

authority

annual

during

for

on

(16)

It is essential that there should be flexibility to allow
re-deployment of resources and adaptation of activities
while respecting the criteria for selecting and ordering
priorities according to magnitude of risk or potential of
effect, public concerns, availability of
interventions or
potential for their development, subsidiarity, added value
and impact on other sectors.

(17) In accordance with Article 2 of Council Decision
1999/468/EC of 28 June 1999 laying down the
implementing powers
procedures
conferred on the Commission (2), measures
the
implementation of
this decision should be adopted by
use of the advisory procedure provided for in Article 3
of that Decision.

the exercise of

for

for

(18) The Agreement on the European Economic Area (EEA
Agreement) provides for greater cooperation in the field
of public health between the European Community and
its Member States, on the one hand, and the countries of
the European Free Trade Association participating in the
European Economic Area (EFTA/EEA countries), on the
other. Provision should also be made to open the
the associated central
programme to participation of
and eastern European countries in accordance with the
in
conditions established in the Europe Agreements,
their additional protocols and in the decisions of
the
funded by
respective Association Councils, of Cyprus,
the
additional
procedures to be agreed with that country, as well as of
Malta and Turkey, funded by additional appropriations, in
accordance with the provisions of the Treaty.

accordance with

appropriations

in

(19) Cooperation with third countries and the competent inter-
national organisations in the sphere of health should be
fostered.

(20) In order

to increase the value and impact of

the
programme there should be monitoring and evaluation
of the measures taken. It should be possible to adjust or
modify the programme in the light of these evaluations
and of developments that may take place in the general
context of Community action in health and health-related
fields.

(1) OJ C 172, 18.6.1999, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.

the previous framework in order

(21) The programme of Community action in the field of
public health builds on the activities and the programmes
to ensure a
under
smooth
and
expandings on their actions. The decisions concerning
those programmes should therefore be repealed with
effect from the date of entry into force of this Decision,

therefrom, while

transition

adapting

HAVE DECIDED AS FOLLOWS:

Article 1

Establishment of the programme

1.
This decision establishes a programme of Community
action in the field of public health, hereinafter referred to as
Bthe programmeC.

2.
The programme shall be implemented in the period
starting on 1 January 2001 and ending on 31 December 2006.

Article 2

Overall aim and general objectives

1.
The programme shall aim to make a contribution towards
the attainment of a high level of health protection by directing
action towards improving public health, preventing human
illness and diseases, and obviating sources of danger to health.

The programme

2.
objectives:

shall have

the

following

general

(a) To improve information and knowledge for the devel-
opment of public health and the strengthening and main-
tenance of effective health interventions and efficient health
systems, by developing and operating a well-structured and
comprehensive system for collecting, analysing, evaluating
and imparting health information and knowledge
to
competent authorities, health professionals and the public,
and by undertaking assessments of and reporting on health
status and health-related policies, systems and measures;

(b) To enhance the capability of responding rapidly and in a
coordinated fashion to threats to health by the devel-
opment,
strengthening and assistance to the capacity,
operation and inter-linking of surveillance, early warning
and rapid reaction mechanisms covering health hazards;

(c) To address health determinants through health promotion
and disease prevention measures, through support to and
the development of broad health promotion activities and
disease prevention actions and specific risk reduction and
elimination instruments.

Article 3

Community actions

1.
The general objectives of the programme as set out in
Article 2 shall be pursued by means of the following groups of
actions, the objectives and operational content of which are
described in the Annex:

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(a) Improving health information, by:

9 developing and operating a health monitoring system;

9 developing and using mechanisms for analysis, advice,
information and consultation on health

reporting,
issues.

(b) Responding rapidly to health threats, by:

9 enhancing the capacity to tackle communicable diseases;

9 strengthening the capacity to tackle other health threats.

(c) Addressing health determinants, by:

9 developing strategies and measures on lifestyle-related

health determinants;

9 developing strategies and measures on socio-economic

health determinants;

9 developing strategies and measures on health deter-

minants related to the environment.

(f) Promotion of

the availability and, where appropriate,
provision of information by the Community and authorities
and competent organisations in the Member States,
to
health professionals and to the public.

(g) Support for the development and implementation by the
Community and the Member States of disease prevention
and health promotion activities involving, as appropriate,
non-governmental organisations, and to innovative or pilot
projects of value to all Member States.

Article 4

Joint actions

As part of the effort to ensure a high level of health protection
in the definition and implementation of all Community policies
and activities, the measures of the programme may be imple-
mented as joint actions with related Community programmes
and actions, notably in the areas of consumer protection, social
protection, research and technological development, telematic
interchange of data between administrations (IDA), statistics,
education and environment, and with actions undertaken by
the Joint Research Centre and Community agencies.

2.
The actions set out in paragraph 1 shall be implemented
through the following types of measures, which may, where
appropriate, be combined and involve the countries referred to
in Article 9:

Article 5

Implementation

(a) Support

for

the preparation of Community legislative
instruments and for cooperation on the position of the
Community and its Member States in fora in which health-
related matters are discussed.

The Commission shall ensure the implementation of the
1.
actions set out in Article 3. To this end,
in
accordance with Article 8(2), measures concerning the annual
plan of work and for monitoring.

it shall adopt,

(b) Support for the development of the statistical part of health
information in the context of the Community Statistical
Programme and for the preparation and dissemination of
reports and communications on the situation on specific
health topics in all Member States as well as reviews and
advice on issues of interest to the Community and to all
Member States.

The Member States shall

take appropriate action to
2.
secure, nationally,
the coordination, organisation and the
follow-up needed for the attainment of the objectives of the
involving all the parties concerned with public
programme,
health in accordance with national
legislation and practice.
They shall endeavour to take the necessary steps to ensure
the efficient running of the programme.

(c) Development of, and support for information and consul-
tation on health and health-related matters at Community
level,
involving representative organisations of patients,
health professionals and other stakeholders.

(d) Support for the mobilisation of resources to counter health
threats and react to unforeseen events, undertake investi-
gations, and coordinate responses at Community and
Member State level.

The Commission and Member States shall take appropriate
action to develop mechanisms established at Community and
national level to achieve the objectives of the programme. They
shall ensure that appropriate information is provided about
the widest
actions supported by the programme and that
possible participation is obtained
requiring
in actions
implementation through local and regional authorities and
non-governmental organisations.

(e) Support for the sharing of experience and exchange of
information between the Community and authorities and
competent organisations in the Member States, and for
building capacity to plan for, and respond to health
threats and provide appropriate training.

3.
The Commission, in cooperation with the Member States,
shall ensure the transition between the actions developed
within the public health programmes referred to in Article
12 and those to be implemented under the programme.

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Article 6

Article 10

Consistency and complementarity

International cooperation

The Commission shall ensure that there is consistency and
to be implemented
complementarity between the actions
under the programme and those implemented under other
Community
the
Commission shall identify those proposals of relevance to the
objectives and actions of the programme and shall inform the
committee referred to in Article 8(1).

particular,

activities.

policies

and

In

Article 7

Funding

1.
The financial framework for the implementation of the
programme for the period referred to in Article 1 is hereby set
at EUR 300 million.

The annual appropriations shall be authorised by the
financial

authority within the

limits of

the

2.
budgetary
perspectives.

Article 8

Committee

The Commission shall be assisted by a committee
the Member States and

1.
composed of
representatives of
chaired by the representative of the Commission.

2. Where reference is made to this paragraph, the advisory
procedure laid down in Article 3 of Decision 1999/468/EC
in compliance with Article 7(3) and Article 8
shall apply,
thereof.

In the course of implementing the programme, cooperation
with third countries and with international organisations
competent in the sphere of public health,
in particular the
World Health Organisation, the Council of Europe and the
Organisation for Economic Cooperation and Development,
shall be fostered.

Article 11

Monitoring, evaluation and dissemination of results

The Commission shall

identify performance indicators,
1.
independent
monitor achievement of results, and carry out
evaluations
(mid-term evaluation) and
during the last year (ex-post evaluation) of the programme.
The evaluations shall particularly assess the impact achieved
and the efficiency of the use of resources.

in the third year

The Commission shall make the results of actions

2.
undertaken and the evaluation reports publicly available.

3.
The Commission shall submit a mid-term report to the
European Parliament and to the Council during the third year
and a final report upon completion of the programme. It shall
incorporate into these reports information on Community
financing within the framework of the programme and on
consistency
relevant
complementarity with
programmes, actions and initiatives, as well as the relevant
evaluation results. The reports shall also be submitted to the
Economic and Social Committee and the Committee of the
Regions.

other

and

Article 12

Repeal

Article 9

The following decisions are hereby repealed:

Participation of the EFTA/EEA countries, the associated
central and eastern European countries, Cyprus, Malta and
Turkey

The programme shall be open to the participation of:

(a) The EFTA/EEA countries in accordance with the conditions

established in the EEA Agreement.

(b) The associated countries of central and eastern Europe, in
accordance with the conditions laid down in the Europe
in their Additional Protocols and in the
Agreements,
Decisions of the respective Association Councils;

Decision No 645/96/EC,

Decision No 646/96/EC,

Decision No 647/96/EC,

Decision No 102/97/EC,

Decision No 1400/97/EC,

Decision No 372/1999/EC,

Decision No 1295/1999/EC,

Decision No 1296/1999/EC.

(c) Cyprus, funded by additional appropriations in accordance

with the procedures to be agreed with that country.

Article 13

Entry into force

(d) Malta and Turkey, funded by additional appropriations in

accordance with the provisions of the Treaty.

This Decision shall enter into force on the date of its publi-
cation in the Official Journal of the European Communities.

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ANNEX

SPECIFIC OBJECTIVES AND ACTIONS

1.

Improving health information and knowledge

1.1. Developing and operating a health monitoring system

1st Objective: To establish Community indicators for health status, diseases and health determinants, methods for the
collection of data for monitoring and analysis, and create corresponding databases

1. Complete the framework for the stepwise establishment of health indicators fully covering health status, diseases,
health resources and interventions, and health determinants, and collect relevant data using methods to be
agreed;

2. Implement the framework for establishing indicators, collecting data and integrating it in databases, and develop

versions of the databases for use by health professionals and the public.

The statistical element of this work will be developed as part of the Community Statistical Programme.

2nd Objective: To improve the system for the transfer and sharing of health data

1. Review and improve the system linking the Commission and Member State health administrations via the

Internet and other means in order to transfer and share Community indicators and data;

2. Make the health data collected in the information system available on Commission and Member States’ Web

sites and regularly update it, for access by administrations, health professionals and the public.

1.2. Developing and using mechanisms for analysis, advice, reporting, information and consultation on health issues

1st Objective: Developing mechanisms for analysis and advice on health issues

1. Develop and operate a Community network to undertake analysis and the preparation of reports on health
status and on the impact of health determinants and policies, identify risk factors and gaps in knowledge and
forecast trends for use in policy formulation, priority setting and resource allocation;

2. Develop and operate a Community network to monitor and undertake analysis and provide advice on health

technologies;

3. Develop and operate a benchmarking mechanism for Community strategies and national policies and activities
on disease prevention, health promotion and health protection, with appropriate parameters and data sets;

4. Develop and operate a Community network to monitor, undertake analysis and provide advice on clinical

guidelines and quality and good practice in health care interventions.

2nd Objective: Reporting on health issues

1. Report on Community health status and identify trends giving rise to concern; report on the impact of selected

activities, policies and measures and health determinants;

2. Present reviews, advice and guidelines on health technologies, health interventions and quality and good

practice.

3rd Objective: Consultation and information and dissemination of reports, advice and recommendations

1. Make available reports, reviews, advice and guidelines referred to in section 1.2 of this Annex on Commission

and Member States’ Web sites and through other appropriate means;

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2. Develop and use mechanisms for informing and consulting representative organisations of patients, health

professionals and other stakeholders about health-related matters at Community level;

3. Identify key information about health and health services, including issues related to access and entitlements,

and make it available, as appropriate, notably to people moving from one Member State to another.

2. Responding rapidly to health threats

2.1. Enhancing the capacity to tackle communicable diseases

1st Objective: Support the further implementation of Decision 2119/98/EC on the Community network on the
epidemiological surveillance and control of communicable diseases

1. Develop:

(a) case definitions, epidemiological and surveillance methods, technical means and procedures, and define
nature and type of data to be collected and transmitted concerning prioritised diseases or special issues;

(b) procedures for the information, consultation and coordination between Member States, for the prevention
and control of communicable diseases, including provisions for a Community incident investigation team;

(c) guidelines on the protective measures to be taken,

in particular at external frontiers and in emergency

situations; links with applicant countries and other third countries;

2. Assemble surveillance data and network inventories held in existing databases;

3. Underpin the network operation in particular in relation to common investigations, training, continuous

assessment and quality assurance.

2nd Objective: To enhance the safety and quality of human blood

1. Complete and implement the framework on high standards of quality and safety for the collection, processing,

storage and distribution and use of whole blood, blood components, and blood precursors;

2. Develop and operate a haemovigilance network and prepare guidelines on the optimum use of blood.

3rd Objective: To enhance the safety and quality of organs and substances of human origin

1. Develop and implement a Community strategy on organs and substances of human origin;

2. Develop and operate a Community network on organs and substances of human origin.

2.2. Strengthening the capacity to tackle other health threats

1st Objective: To develop strategies and mechanisms for responding to non-communicable disease threats

Review and develop strategies on responses to non-communicable disease threats,
developing a Community network with links to existing surveillance, notification and alert mechanisms;

including,

if appropriate,

2nd Objective: To promote the formulation of guidelines and measures on electromagnetic fields and other physical
agents

Review and further develop guidelines and advice on protective and preventive measures on exposure to:

1. electromagnetic fields;

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2. other physical agents, such as optical and ultra-violet radiation, laser radiation, pressure, noise and vibration.

3. Addressing health determinants

3.1. Developing strategies and measures on lifestyle-related health determinants

Objective: To develop and implement, in close cooperation with the Member States, strategies and measures on
lifestyle-related health determinants supporting, in particular, their integration in overall health promotion and
disease prevention policies

Further develop and implement Community strategies,
including benchmarking and analysis of policies and
measures, preparation of reports and guidelines, setting up networks, identification of scope and objectives of
further Community action, and prepare Community instruments on lifestyle-related health determinants.

3.2. Developing strategies and measures on socio-economic health determinants

Objective: To contribute to the formulation and implementation of strategies and measures on socio-economic
determinants

1. Develop a methodology for benchmarking and linking strategies to identify health inequalities using data from
the Community health information system, and, if appropriate, develop Community instruments relating to
health services and insurance arrangements and to the impact on them of Community policies and activities.
Actions will also cover questions related to consumption, cost-effectiveness and expenditure on medicinal
products;

2. Review and identify obstacles to access to health services across internal borders in the Community and, if

appropriate, develop guidelines.

3.3. Develop strategies and measures on health determinants related to the environment

Objective: To contribute to the formulation and implementation of strategies and measures on health determinants
related to the environment

1. Contribute to the further development and implementation of guidelines and recommendations issued by the
European Ministerial Environmental Health Conference and to the monitoring of effectiveness of national
strategies and measures;

2. Identify and prepare reports on good practice in monitoring, early warning systems and measures on pollutants

and associated diseases, and, if appropriate, prepare guidelines.

4. Carrying out the actions

1. The actions to be taken may be funded by service contracts following calls for tender or by subsidies for joint
financing with other sources. In the latter case, the level of financial assistance by the Commission may not
exceed, as a general rule, 50 % of the expenditure actually incurred by the recipient.

2. In carrying out the programme, the Commission may require additional resources,

including recourse to
the Commission’s ongoing assessment of

experts. These requirements will be decided in the context of
resource allocation.

3. The Commission may also undertake information, publication and dissemination actions. It may also undertake

evaluation studies and organise seminars, colloquia or other meetings of experts.

4. The Commission will prepare annual work plans setting out the priorities and actions to be undertaken.
Moreover, it will also specify the arrangements and criteria to be applied in selecting and financing actions
under this programme. In so doing, it will seek the opinion of the Committee mentioned in Article 8.

5. Actions undertaken will fully respect the principles of data protection.