1998D2119 — EN — 23.07.2003 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B DECISION NO 2119/98/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 24 September 1998
setting up a network for the epidemiological surveillance and control of communicable diseases in
the Community
(OJ L 268, 3.10.1998, p. 1)
Amended by:
Official Journal
No page date
►M1Commission Decision 2003/534/EC of 17 July 2003 L 184 35 23.7.2003
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DECISION NO 2119/98/EC OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
of 24 September 1998
setting up a network for the epidemiological surveillance and
control of communicable diseases in the Community
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 27 May 1998,
(1)Whereas the prevention of disease, in particular of the majorhealth scourges, is a priority for Community action, requiring a
global approach coordinated between Member States;
(2)Whereasthe European Parliament, in itsres olution on public
health policy after Maastricht (5), invited the Commission to set
up a transfrontier network to devise working definitions of noti-
fiable diseases, to collect, update, analyse and disseminate
Member States data on such diseases and to work with nationaland international agencies on these matters;
(3)Whereasin itsres olution of 2 June 1994 (6) on the framework
for Community action in the field of public health the Council
agreed that priority should be given at present to communicable
diseases in particular;
(4)Whereasin itsconclus ionsof 13 December 1993 (7) the Council
considered that there was a need to develop at Community level
a network for the surveillance and control of communicable
diseases, the main purpose of which would be to collect andcoordinate information from monitoring networksin the MemberStates;
(5)Whereas in those same conclusions the Council requested the
Commission to devote special attention, in its proposals relating
to the framework for action in the field of public health, tosetting up an epidemiological network in the Community, takingaccount of the current proceedings and mechanisms existing atCommunity and at Member State level, and ensuring the
comparability and compatibility of data;
(6)Whereasin their res olution of 13 November 1992 on the moni-
toring and surveillance of communicable diseases (8) the Council
and the Ministers for Health, meeting within the Council, under-lined the desirability of improving, within the Community, the1998D2119 — EN — 23.07.2003 — 001.001 — 2
(1) OJ C 123, 26. 4. 1996, p. 10 and
OJ C 103, 2. 4. 1997, p. 11.
(2) OJ C 30, 30. 1. 1997, p. 1.
(3) OJ C 337, 11. 11. 1996, p. 67.
(4) Opinion of the European Parliament of 13 November 1996 (OJ C 362, 2. 12.
1996, p. 111), Council Common Position of 22 July 1997 (OJ C 284, 19. 9.
1997, p. 10) and Decision of the European Parliament of 14 January 1998
(OJ C 34, 2. 2. 98, p. 70). Decision of the European Parliament of 15 July1998 (OJ C 292, 21. 9. 1998). Council Decision of 20 July 1998.
(
5) OJ C 329, 6. 12. 1993, p. 375.
(6) OJ C 165, 17. 6. 1994, p. 1.
(7) OJ C 15, 18. 1. 1994, p. 6.
(8) OJ C 326, 11. 12. 1992, p. 1.
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coverage and effectiveness of existing networks between
Member States for the surveillance of communicable diseases(including data-processing networks), and also the desirability
of maintaining, establishing or strengthening coordination
between them for monitoring outbreaksof communicablediseases, where such action could add to the value of existingmeasures;
(7)Whereas in that same resolution, the Council and the Ministersfor Health, meeting within the Council, underlined the value ofcollecting data from the Member Stateson a limited number ofrare and serious diseases which require large samples for epide-
miological study;
(8)Whereas in that same resolution the Council and the Ministers
for Health, meeting within the Council, invited the Commission
to examine the desirability of giving priority to certain suitable
proposals relating to the control and surveillance of communic-able diseases, in the light, inter alia , of their estimated cost-
effectiveness;
(9)Whereas, in accordance with the principle of subsidiarity, anynew measure taken in an area which does not fall within theexclusive competence of the Community, such as the epidemio-logical surveillance and control of communicable diseases, maybe taken by the Community only if, by reason of the scale or
effects of the proposed action, the objectives of the proposed
action can be better achieved by the Community than by theMember States;
(10)Whereasthe varying levelsand needsof epidemiological s urveil-lance of communicable diseases in the Member States make itnecessary to establish a permanent network at Community level;
(11)Whereas measures to be taken in the health field must take intoaccount other actionsundertaken by the Community in the fieldof public health or which have an impact on public health;
(12)Whereas the measures to be taken under this Decision areadopted excluding any harmonisation of the laws and regulationsof the Member States;
(13)WhereasDecis ion 647/96/EC of the European Parliament and ofthe Council of 29 March 1996 adopting a programme ofCommunity action on the prevention of AIDS and certain othercommunicable diseases within the framework for action in thefield of public health (1996 to 2000) (
1) envisages a number of
Community actionsfor the creation and development of
networksfor the control and s urveillance of certain communic-
able diseases, the early detection of such diseases, andpromotion of the training of field epidemiologists;
(14)Whereascooperation with the competent international organis a-tions, particularly the World Health Organisation, notably withregard to disease classification, must be fostered, as well as theuse of appropriate language and technology;
(15)Whereascooperation with non-member countries , in particular inthe case of the appearance or resurgence of serious communic-able diseases, must be supported;
(16)Whereas the recent appearance or resurgence of serious commu-nicable diseases has demonstrated that when an emergencysituation occurs all necessary information and data gathered inaccordance with an agreed methodology must be communicatedswiftly to the Commission;
(17)Whereas, in order to ensure protection of the population in anemergency, Member Statesmus t exchange relevant data andinformation immediately via the Community network; whereas1998D2119 — EN — 23.07.2003 — 001.001 — 3
(1) OJ L 95, 16. 4. 1996, p. 16.
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priority must be given at all times to the protection of public
health;
(18)WhereasCouncil Directive 92/117/EEC of 17 December 1992concerning measures for protection against specified zoonosesand specified zoonotic agents in animals and products of animalorigin in order to prevent outbreaksof food-borne infectionsandintoxications(
1) appliesequally to information concerning
zoonoses which affect human beings; whereas that same Direc-
tive provides for a system for collecting and transmitting
information on specified zoonoses and zoonotic agents;
(19)Whereasthe s etting-up of a network for the epidemiologicalsurveillance and control of communicable diseases at Commu-nity level necessarily presupposes compliance with the legal
provisions concerning the protection of individuals with regard
to the processing of personal data and the introduction ofarrangementsto guarantee the confidentiality and s ecurity ofsuch data; whereas in this connection the European Parliamentand the Council adopted Directive 95/46/EC (
2);
(20)Whereasthe Community projectsin the field of the telematicinterchange of data between administrations (IDA) (
3) and the
G7 projects should be closely coordinated with the implementa-tion of the Community actionsrelating to the epidemiologicalsurveillance and control of communicable diseases;
(21)Whereas consideration must be given to the efforts deployedwith a view to encouraging international cooperation in thisfield, particularly aspart of a joint plan of action with the UnitedStates;
(22)Whereasit isimportant, in an emergency s ituation, that the
competent national structures and/or authorities should
strengthen their cooperation, in particular with regard to theidentification of biological samples;
(23)Whereasany Community procedureswhich may be s et up forthe rapid exchange of information do not affect the Member
States' rights and obligations under bilateral or multilateral
agreementsand conventions ;
(24)Whereas a procedure needs to be established to promote coordi-nation between the Member Statesconcerning the meas urestheymay decide to take to control the spread of communicable
diseases; whereas the adoption and implementation of these
measures fall within the exclusive competence of the MemberStates;
(25)Whereas it is important that the Commission should implementthe Community network in close cooperation with the Member
States; whereas a procedure therefore needs to be established to
ensure the Member States' full participation in this implementa-tion;
(26)Whereas the costs which may result from the operation of thenetwork at Community level should be met from Community
resources and/or from relevant Community programmes;
(27)Whereas the costs which may result from the operation of the
network at national level will have to be financed by theMember States themselves, unless Community provisionsprovide otherwise;
(28)Whereasa modus vivendi between the European Parliament, the
Council and the Commission concerning the implementingmeasures for acts adopted in accordance with the procedure laid1998D2119 — EN — 23.07.2003 — 001.001 — 4
(1) OJ L 62, 15. 3. 1993, p. 38.
(2) OJ L 281, 23. 11. 1995, p. 31.
(3) OJ L 269, 11. 11. 1995, p. 23.
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down in Article 189b of the Treaty (1) wasconcluded on 20
December 1994,
HAVE ADOPTED THIS DECISION:
Article 1
The objective of this Decision is to set up a network at Community
level to promote cooperation and coordination between the MemberStates, with the assistance of the Commission, with a view to
improving the prevention and control, in the Community, of the cate-
gories of communicable diseases specified in the Annex. This networkshall be used for:
— the epidemiological surveillance of these diseases, and
— an early warning and response system for the prevention and
control of these diseases.
As regards epidemiological surveillance, the network shall be estab-
lished by bringing into permanent communication with one another,
through all appropriate technical means, the Commission and those
structures and/or authorities which, at the level of each Member Stateand under the responsibility of that Member State, are competent atnational level and are charged with collecting information relating tothe epidemiological surveillance of communicable diseases, and byestablishing procedures for the dissemination of the relevant surveil-
lance data at Community level.
As regards the early warning and response system, this network shall
be formed by bringing into permanent communication with one
another, through appropriate means, the Commission and the competent
public health authorities in each Member State responsible for deter-mining the measures which may be required to protect public health.
The Commission shall provide for the coordination of the network in
collaboration with the Member States.
Article 2
For the purpose of this Decision, the following terms shall have the
following meanings:
1. ‘epidemiological surveillance’: the ongoing systematic collection,
analysis, interpretation and dissemination of health data, includingepidemiological studies, concerning the categories of communicablediseases set out in the Annex, in particular relating to the pattern ofspread of such diseases over time and space and analysis of the risk
factors for contracting such diseases, for the purpose of enabling
appropriate preventive measures and counter-measures to be taken;
2. ‘prevention and control of communicable diseases’: the range of
measures, including epidemiological investigations, taken by thecompetent public health authoritiesin the Member Statesto preventand stop the spread of communicable diseases;
3. ‘Community network’: network for the epidemiological surveillance
and control of communicable diseases, namely the system by which
the necessary information for carrying out the activities referred toin points1 and 2 isexchanged.
Article 3
With a view to the effective operation of the Community network with
regard to epidemiological surveillance and to achieving uniform infor-mation within thisframework, the following s hall be determined in
accordance with the procedure laid down in Article 7:
(a) the communicable diseases to be progressively covered by the
Community network;1998D2119 — EN — 23.07.2003 — 001.001 — 5
(1) OJ C 102, 4. 4. 1996, p. 1.
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(b) the criteria for selection of these diseases, having regard to the
categories set out in the Annex and the existing collaborativenetworks for disease surveillance that can be built on;
(c) case definitions, in particular clinical and microbiological charac-
teristics;
(d) the nature and type of data and information to be collected and
transmitted by the structures and/or authorities referred to in thesecond paragraph of Article 1 in the field of epidemiologicalsurveillance and the ways in which such data are to be made
comparable and compatible;
(e) epidemiological and microbiological surveillance methods;
(f) guidelineson the protective meas uresto be taken, in particular at
external frontiersof the Member States , notably in emergencysituations;
(g) guidelineson information and guidesto good practice for the
public;
(h) the appropriate technical meansand the proceduresby which the
data will be disseminated and analysed at Community level.
Article 4
Each structure and/or authority referred to in the second paragraph or
in the third paragraph, whichever isappropriate of Article 1 s hallcommunicate to the Community network:
(a) information regarding the appearance or resurgence of cases of
communicable diseases as referred to in Article 3(a) in the MemberState to which the structure and/or authority belongs, together with
information on control measures applied;
(b) any relevant information concerning the progression of epidemic
situations for which it has responsibility for information collection;
(c) information on unusual epidemic phenomena or new communicable
diseases of unknown origin;
(d) any relevant information in its possession:
— on cases of communicable diseases covered by the categories
set out in the Annex,
— on new communicable diseases of unknown origin in non-
member countries;
(e) information concerning existing and proposed mechanisms and
proceduresfor the prevention and control of communicable
diseases, in particular in emergency situations;
(f) any relevant considerations which could help Member States to
coordinate their effortsfor the prevention and control of commu-nicable diseases, including any counter-measures implemented.
Article 5
The Commission shall make available the information referred to in
Article 3 to all the structures and authorities referred to in Article 1.
Each structure/authority shall ensure that the information which theycommunicate to the network, pursuant to Article 4, is promptlyforwarded to all other participating structures/authorities and theCommission.
Article 6
1. Member States shall, on the basis of the information available
through the Community network, consult each other in liaison withthe Commission with a view to coordinating their efforts for theprevention and control of communicable diseases.
2. Where a Member State intendsto adopt meas uresfor the control
of communicable diseases, it shall, before adopting those measures,inform the other Member States and the Commission on the natureand scope of those measures, through the Community network. The1998D2119 — EN — 23.07.2003 — 001.001 — 6
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Member State in question shall also consult other Member States and
the Commission through the Community network on the nature andscope of intended measures unless the need to protect public health is
so urgent that consultation proves impossible.
3. Where a Member State hasto adopt, asa matter of urgency,
control measures in response to the appearance or resurgence ofcommunicable diseases, it shall, as soon as possible, inform through
the Community network the other Member States and the Commission.
In duly justified specific cases, appropriate prevention and protection
measures, adopted by mutual agreement among Member States inconjunction with the Commission, may be taken by the Member States
which so desire.
4. Member States shall, on the basis of their consultations and the
information provided, coordinate among themselves in liaison with theCommission with regard to the measures which they have adopted, or
intend to adopt at national level.
5. Proceduresconcerning the information and cons ultation referred
to in paragraphs1, 2 and 3 and proceduresconcerning the coordinationreferred to in paragraphs 1 and 4 shall be established in accordance
with the procedure laid down in Article 7.
Article 7
1. For the purposes of implementing this Decision, the Commission
shall be assisted by a committee composed of representatives of each
of the Member States and chaired by the representative of the Commis-sion.
2. The representative of the Commission shall submit to the
committee a draft of the measures to be taken. The committee shall
deliver itsopinion on the draft within a time limit which the chairmanmay lay down according to the urgency of the matter. The opinionshall be delivered by the majority laid down in Article 148(2) of theTreaty 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 Stateswithin the committee s hall be weighted in themanner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are
in accordance with the opinion of the committee.
(b) If the measures envisaged are not in accordance with the opinion
of the committee, or if no opinion is delivered, the Commission
shall without delay submit to the Council a proposal relating tothe measures to be taken. The Council shall act by a qualifiedmajority.
If within three monthsof the matter being referred to it the Council has
not acted, the proposed measures shall be adopted by the Commission.
Article 8
The Annex may be amended or supplemented in accordance with the
procedure laid down in Article 7.
Article 9
Each Member State shall designate, within six months of the entry into
force of this Decision, the structures and/or authorities referred to in
the second and third paragraphs of Article 1 and shall notify theCommission and the other Member States thereof. The structures and/or authorities which have been so designated shall be described inpublic by the Member Statesasforming part of the Communitynetwork established by this Decision.
Article 10
For the purposes of this Decision, the competent authorities of the
Member States and the Commission shall foster cooperation with non-1998D2119 — EN — 23.07.2003 — 001.001 — 7
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member countriesand international organis ationscompetent in the field
of public health, in particular the World Health Organisation.
Article 11
This Decision shall apply without prejudice to Directives 92/117/EEC
and 95/46/EC.
Article 12
1. This Decision shall not affect the right of the Member States to
maintain or introduce other arrangements, procedures and measures
for their national systems for the epidemiological surveillance and
control of communicable diseases.
2. This Decision shall not affect Member States' rights and obliga-
tionsderiving from exis ting or future bilateral or multilateralagreementsor conventionsin the field covered by thisDecis ion.
Article 13
The Commission, with the help of the Member States, shall ensure that
there is consistency and complementarity between this Decision andthe relevant Community programmes and initiatives, including those
in the context of public health action aswell as , in particular, the
framework programme for statistical information, projects in the fieldof telematic interchange of data between administrations and the frame-work programme for research and technological development,especially the telematics applications of the latter programme.
Article 14
1. The Commission shall submit regular reports evaluating the
operation of the Community network to the European Parliament andthe Council.
2. The first report, which shall be submitted within three years after
the entry into force of this Decision shall, in particular, identify thoseelementsof the Community network which s hould be improved oradapted. It shall also include any proposal that the Commissionconsiders necessary for the amendment or adaptation of this Decision.
3. The Commission shall conduct an evaluation of the Community
network every five yearsthereafter, paying particular attention to its
structural capacity and effective use of resources, and shall submit a
report to the European Parliament and the Council.
Article 15
This Decision shall enter into force on 3 January 1999.
Article 16
This Decision is addressed to the Member States.1998D2119 — EN — 23.07.2003 — 001.001 — 8
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ANNEX
LIST INDICATING CATEGORIES OF COMMUNICABLE DISEASES
— Diseases preventable by vaccination
— Sexually-transmitted diseases
— Viral hepatitis
— Food-borne diseases— Water-borne diseases and diseases of environmental origin— Nosocomial infections— Other diseases transmissible by non-conventional agents (including Creutz-
feldt-Jakob's disease)
— Diseases covered by the international health regulations (yellow fever,
cholera and plague)
— Other diseases (rabies, typhus, viral haemorrhagic fevers, malaria and any
other as yet unclassified serious epidemic disease, including diseases that
are caused by agents specifically engineered for the purpose of maximising
morbidity and/or mortality upon deliberate release, etc.).1998D2119 — EN — 23.07.2003 — 001.001 — 9
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