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

Odločba št. 2119/98/ES Evropskega parlamenta in Sveta

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

z dne 24. septembra 1998

Having regard to the Treaty establishing the European Community, and in particular Article 129 thereof,

o vzpostavitvi mreže epidemiološkega spremljanja in obvladovanja nalezljivih bolezni v Skupnosti

Having regard to the proposal from the Commission (1),

EVROPSKI PARLAMENT IN SVET EVROPSKE UNIJE STA –

Having regard to the opinion of the Economic and Social Committee (2),

ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti, zlasti člena 129 Pogodbe,

Having regard to the opinion of the Committee of the Regions (3),

ob upoštevanju predloga Komisije [1],

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,

ob upoštevanju mnenja Ekonomsko-socialnega odbora [2],

(1) Whereas the prevention of disease, in particular of the major health scourges, is a priority for Community action, requiring a global approach coordinated between Member States;

ob upoštevanju mnenja Odbora regij [3],

(2) Whereas the European Parliament, in its resolution on public health policy after Maastricht (5), invited the Commission to set up a transfrontier network to devise working definitions of notifiable diseases, to collect, update, analyse and disseminate Member States data on such diseases and to work with national and international agencies on these matters;

skladno s postopkom, določenim v členu 189b Pogodbe [4] v luči skupnega besedila, ki ga je potrdil Spravni odbor dne 27. maja 1998,

(3) Whereas in its resolution 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;

(1) ker je preprečevanje bolezni, zlasti močno razširjenih težkih bolezni, prednostno pri delovanju Skupnosti, kar zahteva globalen pristop, usklajen med državami članicami;

(4) Whereas in its conclusions of 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 and coordinate information from monitoring networks in the Member States;

(2) ker je Evropski parlament v svoji resoluciji o politiki javnega zdravja po Maastrichtu [5] pozval Komisijo, da vzpostavi čezmejno mrežo, ki bo pripravila delovne opredelitve bolezni, ki jih je treba prijaviti, zbira, ažurira, analizira in posreduje državam članicam podatke o teh boleznih in v teh zadevah sodeluje z nacionalnimi in mednarodnimi agencijami;

(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, to setting up an epidemiological network in the Community, taking account of the current proceedings and mechanisms existing at Community and at Member State level, and ensuring the comparability and compatibility of data;

(3) ker se je v svoji resoluciji z dne 2. junija 1994 [6] o okviru za delovanje Skupnosti na področju javnega zdravja Svet strinjal, da je sedaj treba dati prednost zlasti nalezljivim boleznim;

(6) Whereas in their resolution of 13 November 1992 on the monitoring and surveillance of communicable diseases (8) the Council and the Ministers for Health, meeting within the Council, underlined the desirability of improving, within the Community, the 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 outbreaks of communicable diseases, where such action could add to the value of existing measures;

(4) ker je v svojih sklepnih ugotovitvah z dne 13. decembra 1993 [7] Svet upošteval, da je na ravni Skupnosti treba razviti mrežo za spremljanje in obvladovanje nalezljivih bolezni, njen glavni namen pa bi bil zbiranje in usklajevanje informacij iz mrež za spremljanje v državah članicah;

(7) Whereas in that same resolution, the Council and the Ministers for Health, meeting within the Council, underlined the value of collecting data from the Member States on a limited number of rare and serious diseases which require large samples for epidemiological study;

(5) ker je Svet v teh istih sklepnih ugotovitvah prosil Komisijo, da v svojih predlogih glede okvirja za delovanje na področju javnega zdravja posveti posebno pozornost vzpostavitvi epidemiološke mreže v Skupnosti, ob upoštevanju obstoječih postopkov in mehanizmov v Skupnosti in na ravni držav članic, in ob zagotovitvi primerljivosti in združljivosti podatkov;

(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 communicable diseases, in the light, inter alia, of their estimated cost-effectiveness;

(6) ker so v resoluciji z dne 13. novembra 1992 o spremljanju nalezljivih bolezni [8] Svet in ministri za zdravje, ki so se sestali v Svetu, poudarili zaželenost, da se znotraj Skupnosti izboljša pokritost in učinkovitost obstoječih mrež za spremljanje nalezljivih bolezni med državami članicami (vključno z mrežami za obdelavo podatkov), in tudi zaželenost, da se ohrani, vzpostavi ali okrepi usklajevanje med njimi za spremljanje izbruhov nalezljivih bolezni, kjer bi takšno delovanje lahko dodatno izboljšalo obstoječe ukrepe;

(9) Whereas, in accordance with the principle of subsidiarity, any new measure taken in an area which does not fall within the exclusive competence of the Community, such as the epidemiological surveillance and control of communicable diseases, may be 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 the Member States;

(7) ker so v tej isti resoluciji Svet in ministri za zdravje, ki so se sestali v Svetu, poudarili pomembnost zbiranja podatkov iz držav članic o omejenem številu redkih in hudih bolezni, kar zahteva velike vzorce za epidemiološko raziskavo;

(10) Whereas the varying levels and needs of epidemiological surveillance of communicable diseases in the Member States make it necessary to establish a permanent network at Community level;

(8) ker so v tej isti resoluciji Svet in ministri za zdravje, ki so se sestali v Svetu, pozvali Komisijo, da preuči, ali je zaželeno dajati prednost določenim ustreznim predlogom v zvezi z obvladovanjem in epidemiološkim spremljanjem nalezljivih bolezni, med drugim v luči njihove ocenjene stroškovne učinkovitosti;

(11) Whereas measures to be taken in the health field must take into account other actions undertaken by the Community in the field of public health or which have an impact on public health;

(9) ker lahko v skladu z načelom subsidiarnosti vsak nov ukrep, sprejet na področju, ki ne sodi v izključno pristojnost Skupnosti tako kot epidemiološko spremljanje in obvladovanje nalezljivih bolezni, Skupnost sprejme le, če se lahko cilji zaradi obsega ali učinkov predlaganega delovanja lažje dosežejo na ravni Skupnosti kot v posameznih državah članicah;

(12) Whereas the measures to be taken under this Decision are adopted excluding any harmonisation of the laws and regulations of the Member States;

(10) ker je zaradi različnih ravni in potreb po epidemiološkem spremljanju nalezljivih bolezni v državah članicah treba vzpostaviti stalno mrežo na ravni Skupnosti;

(13) Whereas Decision 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) (9) envisages a number of Community actions for the creation and development of networks for the control and surveillance of certain communicable diseases, the early detection of such diseases, and promotion of the training of field epidemiologists;

(11) ker morajo ukrepi, ki jih je treba sprejeti na področju zdravstva, upoštevati ostale dejavnosti Skupnosti na področju javnega zdravja ali ki vplivajo na javno zdravje;

(14) Whereas cooperation with the competent international organisations, particularly the World Health Organisation, notably with regard to disease classification, must be fostered, as well as the use of appropriate language and technology;

(12) ker so ukrepi, ki jih je treba sprejeti po tej odločbi, sprejeti brez kakršnega koli usklajevanja zakonov in drugih predpisov držav članic;

(15) Whereas cooperation with non-member countries, in particular in the case of the appearance or resurgence of serious communicable diseases, must be supported;

(13) ker Odločba 647/96/ES Evropskega parlamenta in Sveta z dne 29. marca 1996 o sprejetju programa delovanja Skupnosti na področju preprečevanja aidsa in nekaterih drugih nalezljivih bolezni v okviru delovanja na področju javnega zdravja (1996 do 2000) [9], predvideva številne dejavnosti Skupnosti za vzpostavitev in razvoj mrež za obvladovanje in spremljanje nekaterih nalezljivih bolezni, zgodnje odkrivanje teh bolezni in spodbujanje usposabljanja terenskih epidemiologov;

(16) Whereas the recent appearance or resurgence of serious communicable diseases has demonstrated that when an emergency situation occurs all necessary information and data gathered in accordance with an agreed methodology must be communicated swiftly to the Commission;

(14) ker je treba pospeševati sodelovanje s pristojnimi mednarodnimi organizacijami, zlasti s Svetovno zdravstveno organizacijo, predvsem glede klasifikacije bolezni, in uporabe ustreznega jezika in tehnologije;

(17) Whereas, in order to ensure protection of the population in an emergency, Member States must exchange relevant data and information immediately via the Community network; whereas priority must be given at all times to the protection of public health;

(15) ker je treba podpirati sodelovanje z državami nečlanicami, zlasti ob pojavu ali ponovnem pojavu hudih nalezljivih bolezni;

(18) Whereas Council Directive 92/117/EEC of 17 December 1992 concerning measures for protection against specified zoonoses and specified zoonotic agents in animals and products of animal origin in order to prevent outbreaks of food-borne infections and intoxications (10) applies equally to information concerning zoonoses which affect human beings; whereas that same Directive provides for a system for collecting and transmitting information on specified zoonoses and zoonotic agents;

(16) ker je nedaven pojav ali ponovni pojav hudih nalezljivih bolezni pokazal, da je treba ob pojavu nujnega primera vse potrebne informacije in podatke, zbrane po dogovorjeni metodologiji, naglo sporočiti Komisiji;

(19) Whereas the setting-up of a network for the epidemiological surveillance and control of communicable diseases at Community level necessarily presupposes compliance with the legal provisions concerning the protection of individuals with regard to the processing of personal data and the introduction of arrangements to guarantee the confidentiality and security of such data; whereas in this connection the European Parliament and the Council adopted Directive 95/46/EC (11);

(17) ker morajo države članice za zagotovitev varstva prebivalstva v nujnem primeru takoj izmenjati ustrezne podatke in informacije po mreži Skupnosti; ker mora varstvo javnega zdravja vedno imeti prednost;

(20) Whereas the Community projects in the field of the telematic interchange of data between administrations (IDA) (12) and the G7 projects should be closely coordinated with the implementation of the Community actions relating to the epidemiological surveillance and control of communicable diseases;

(18) ker se Direktiva Sveta 92/117/EGS z dne 17. decembra 1992 o ukrepih za zaščito proti določenim zoonozam in določenim povzročiteljem zoonoz v živalih in izdelkih živalskega izvora, z namenom, da bi preprečili izbruhe okužb s hrano in zastrupitev [10] prav tako uporablja za informacije o zoonozah, ki prizadenejo ljudi; ker ta direktiva določa sistem za zbiranje in posredovanje informacij o določenih zoonozah in njihovih povzročiteljih;

(21) Whereas consideration must be given to the efforts deployed with a view to encouraging international cooperation in this field, particularly as part of a joint plan of action with the United States;

(19) ker vzpostavitev mreže za epidemiološko spremljanje in obvladovanje nalezljivih bolezni na ravni Skupnosti nujno predpostavlja ravnanje, skladno s pravnimi predpisi o zaščiti posameznikov pri obdelavi osebnih podatkov in uvedbi sistemov za zagotavljanje zaupnosti in varnosti teh podatkov; ker sta Evropski parlament in Svet v zvezi s tem sprejela Direktivo 95/46/ES [11];

(22) Whereas it is important, in an emergency situation, that the competent national structures and/or authorities should strengthen their cooperation, in particular with regard to the identification of biological samples;

(20) ker morajo biti projekti Skupnosti na področju telematske izmenjave podatkov med upravami (IDA) [12] in projekti G7 dobro usklajeni z izvajanjem dejavnosti Skupnosti na področju epidemiološkega spremljanja in obvladovanja nalezljivih bolezni;

(23) Whereas any Community procedures which may be set up for the rapid exchange of information do not affect the Member States' rights and obligations under bilateral or multilateral agreements and conventions;

(21) ker je treba upoštevati prizadevanja z namenom pospeševanja mednarodnega sodelovanja na tem področju, zlasti kot del skupnega načrta delovanja z Združenimi državami;

(24) Whereas a procedure needs to be established to promote coordination between the Member States concerning the measures they may 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 Member States;

(22) ker je pomembno, da pristojne nacionalne strukture in/ali organi v nujnih primerih okrepijo sodelovanje, posebno kar zadeva identifikacijo bioloških vzorcev;

(25) Whereas it is important that the Commission should implement the 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 implementation;

(23) ker kakršni koli postopki Skupnosti, ki jih je mogoče sprožiti za hitro izmenjavo informacij, ne vplivajo na pravice in obveznosti držav članic iz dvostranskih in večstranskih sporazumov in konvencij;

(26) Whereas the costs which may result from the operation of the network at Community level should be met from Community resources and/or from relevant Community programmes;

(24) ker je treba določiti postopek za pospeševanje usklajevanja med državami članicami glede ukrepov, ki bi jih utegnile sprejeti za obvladovanje širjenja nalezljivih bolezni; ker sprejetje in izvajanje teh ukrepov sodi v izključno pristojnost držav članic;

(27) Whereas the costs which may result from the operation of the network at national level will have to be financed by the Member States themselves, unless Community provisions provide otherwise;

(25) ker je pomembno, da Komisija izvaja mrežo Skupnosti v tesnem sodelovanju z državami članicami; ker mora biti zato določen postopek, ki bo zagotovil polno sodelovanje držav članic pri tem izvajanju;

(28) Whereas a modus vivendi 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 (13) was concluded on 20 December 1994,

(26) ker naj bi se stroški, ki lahko nastanejo zaradi delovanja mreže na ravni Skupnosti, poravnali iz virov Skupnosti in/ali iz ustreznih programov Skupnosti;

HAVE ADOPTED THIS DECISION:

(27) ker bodo stroške, ki lahko nastanejo zaradi delovanja mreže na nacionalni ravni, morale kriti države članice same, razen če določbe Skupnosti določajo drugače;

(28) ker je bil modus vivendi med Evropskim parlamentom, Svetom in Komisijo glede izvajanja ukrepov za pravne akte, sprejete v skladu s postopkom, določenim v členu 189b Pogodbe [13], sklenjen 20. decembra 1994 –

SPREJELA NASLEDNJO ODLOČBO:

Article 1

Člen 1

The objective of this Decision is to set up a network at Community level to promote cooperation and coordination between the Member States, with the assistance of the Commission, with a view to improving the prevention and control, in the Community, of the categories of communicable diseases specified in the Annex. This network shall be used for:

Cilj te odločbe je vzpostaviti mrežo na ravni Skupnosti za pospeševanje sodelovanja in usklajevanje med državami članicami s pomočjo Komisije z namenom izboljšanja preprečevanja in obvladovanja vrst nalezljivih bolezni v Skupnosti, navedenih v Prilogi. Ta mreža se bo uporabljala za:

- the epidemiological surveillance of these diseases, and

- epidemiološko spremljanje teh bolezni in

- an early warning and response system for the prevention and control of these diseases.

- sistem zgodnjega obveščanja in odzivanja za preprečevanje in obvladovanje teh bolezni.

As regards epidemiological surveillance, the network shall be established 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 State and under the responsibility of that Member State, are competent at national level and are charged with collecting information relating to the epidemiological surveillance of communicable diseases, and by establishing procedures for the dissemination of the relevant surveillance data at Community level.

Glede epidemiološkega spremljanja se s pomočjo vseh ustreznih tehničnih sredstev in z določitvijo postopkov za posredovanje podatkov o spremljanju na ravni Skupnosti vzpostavi mreža za stalne stike med Komisijo in tistimi strukturami in/ali organi, ki so na nacionalni ravni posameznih držav članic odgovorni in pristojni ter zadolženi za zbiranje informacij o epidemiološkem spremljanju nalezljivih bolezni.

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 determining the measures which may be required to protect public health.

Glede sistema zgodnjega obveščanja in odzivanja za preprečevanje in obvladovanje se s pomočjo ustreznih sredstev vzpostavi mreža s stalnim stikom med Komisijo in pristojnimi organi na področju javnega zdravja v posamezni državi članici, odgovornimi za določanje ukrepov, ki bi lahko bili potrebni za zavarovanje javnega zdravja.

The Commission shall provide for the coordination of the network in collaboration with the Member States.

Komisija skrbi za uskladitev mreže v sodelovanju z državami članicami.

Člen 2

Article 2

Za namen te odločbe imajo naslednji pojmi naslednje pomene:

For the purpose of this Decision, the following terms shall have the following meanings:

1. "epidemiološko spremljanje": stalno sistematično zbiranje, analiziranje, razlaga in razširjanje zdravstvenih podatkov, vključno z epidemiološkimi študijami glede vrst nalezljivih bolezni, določenih v Prilogi, zlasti glede poti in načinov širjenja teh bolezni v času in prostoru, in analiza dejavnikov tveganja za zmanjšanje takih bolezni s ciljem, da se uvedejo ustrezni preventivni in protiepidemijski ukrepi;

1. 'epidemiological surveillance`: the ongoing systematic collection, analysis, interpretation and dissemination of health data, including epidemiological studies, concerning the categories of communicable diseases set out in the Annex, in particular relating to the pattern of spread 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. "preprečevanje in obvladovanje nalezljivih bolezni": niz ukrepov, vključno z epidemiološkimi raziskavami pristojnih organov za javno zdravje v državah članicah, da bi preprečili in ustavili širjenje nalezljivih bolezni;

2. 'prevention and control of communicable diseases`: the range of measures, including epidemiological investigations, taken by the competent public health authorities in the Member States to prevent and stop the spread of communicable diseases;

3. "mreža Skupnosti": mreža za epidemiološko spremljanje in obvladovanje nalezljivih bolezni, sistem, s katerim se izmenjujejo potrebne informacije za izvajanje dejavnosti iz točk 1 in 2.

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 to in points 1 and 2 is exchanged.

Člen 3

Zaradi učinkovitega delovanja mreže Skupnosti glede epidemiološkega spremljanja in zaradi pridobitve enotnih informacij v tem okviru je treba v skladu s postopkom, določenim v členu 7, določiti naslednje:

Article 3

(a) nalezljive bolezni, ki naj bodo postopoma vključene v mrežo Skupnosti;

With a view to the effective operation of the Community network with regard to epidemiological surveillance and to achieving uniform information within this framework, the following shall be determined in accordance with the procedure laid down in Article 7:

(b) merila za izbor teh bolezni, ob upoštevanju vrst, določenih v Prilogi in obstoječih mrež sodelovanja pri spremljanju bolezni, ki se lahko dograjujejo;

(a) the communicable diseases to be progressively covered by the Community network;

(c) opredelitve primerov, zlasti klinične in mikrobiološke značilnosti;

(b) the criteria for selection of these diseases, having regard to the categories set out in the Annex and the existing collaborative networks for disease surveillance that can be built on;

(d) naravo in vrsto podatkov in informacij, ki jih morajo zbrati in posredovati strukture in/ali organi iz drugega odstavka člena 1 na področju epidemiološkega spremljanja, in načine, s katerimi bo omogočeno, da bodo takšni podatki primerljivi in združljivi;

(c) case definitions, in particular clinical and microbiological characteristics;

(e) epidemiološke in mikrobiološke metode spremljanja;

(d) the nature and type of data and information to be collected and transmitted by the structures and/or authorities referred to in the second paragraph of Article 1 in the field of epidemiological surveillance and the ways in which such data are to be made comparable and compatible;

(f) smernice glede zaščitnih ukrepov, ki jih je treba sprejeti, zlasti na zunanjih mejah držav članic, predvsem v nujnih primerih;

(e) epidemiological and microbiological surveillance methods;

(g) smernice za pripravo informacij in navodil pravilnega ravnanja za javnost;

(f) guidelines on the protective measures to be taken, in particular at external frontiers of the Member States, notably in emergency situations;

(h) ustrezna tehnična sredstva in postopke, s katerimi se bodo podatki posredovali in analizirali na ravni Skupnosti.

(g) guidelines on information and guides to good practice for the public;

Člen 4

(h) the appropriate technical means and the procedures by which the data will be disseminated and analysed at Community level.

Vsaka struktura in/ali organ iz drugega ali tretjega odstavka člena 1, kateri koli je ustrezen, posreduje mreži Skupnosti:

(a) informacije o pojavu ali ponovnem pojavu primerov nalezljivih bolezni iz člena 3(a), v državi članici, ki ji pripada struktura in/ali organ, skupaj z informacijami o uporabljenih ukrepih za obvladovanje;

Article 4

(b) vse pomembne informacije o poslabšanju epidemijskih razmer, za katerih zbiranje je odgovorna;

Each structure and/or authority referred to in the second paragraph or in the third paragraph, whichever is appropriate of Article 1 shall communicate to the Community network:

(c) informacije o nenavadnih epidemijskih pojavih ali novih nalezljivih boleznih neznanega izvora;

(a) information regarding the appearance or resurgence of cases of communicable diseases as referred to in Article 3(a) in the Member State to which the structure and/or authority belongs, together with information on control measures applied;

(d) vsako pomembno informacijo, ki jo poseduje:

(b) any relevant information concerning the progression of epidemic situations for which it has responsibility for information collection;

- o primerih nalezljivih bolezni iz vrst, določenih v Prilogi,

(c) information on unusual epidemic phenomena or new communicable diseases of unknown origin;

- o novih nalezljivih boleznih neznanega izvora v državah nečlanicah;

(d) any relevant information in its possession:

(e) informacije o obstoječih in predlaganih mehanizmih in postopkih za preprečevanje in obvladovanje nalezljivih bolezni, predvsem v nujnih primerih;

- on cases of communicable diseases covered by the categories set out in the Annex,

(f) vse pomembne pomisleke, ki bi lahko pomagali državam članicam uskladiti prizadevanja za preprečevanje in obvladovanje nalezljivih bolezni, vključno z vsemi izvedenimi protiepidemijskimi ukrepi.

- on new communicable diseases of unknown origin in non-member countries;

Člen 5

(e) information concerning existing and proposed mechanisms and procedures for the prevention and control of communicable diseases, in particular in emergency situations;

Komisija daje vsem strukturam in organom člena 1 na razpolago informacije člena 3. Vsaka struktura in/ali organ zagotovi, da informacije, ki jih posreduje mreži v skladu s členom 4, nemudoma posreduje vsem drugim sodelujočim strukturam/organom in Komisiji.

(f) any relevant considerations which could help Member States to coordinate their efforts for the prevention and control of communicable diseases, including any counter-measures implemented.

Člen 6

1. Države članice se na podlagi informacij, razpoložljivih prek mreže Skupnosti, med seboj posvetujejo v povezavi s Komisijo z namenom uskladitve svojih prizadevanj za preprečevanje in obvladovanje nalezljivih bolezni.

Article 5

2. Ko namerava država članica sprejeti ukrepe za obvladovanje nalezljivih bolezni, pred sprejetjem teh ukrepov prek mreže Skupnosti obvesti ostale države članice in Komisijo o vrsti in obsegu teh ukrepov. Zadevna država članica se posvetuje z drugimi državami članicami in Komisijo prek mreže Skupnosti o vrsti in obsegu nameravanih ukrepov, razen če je potreba po varstvu javnega zdravja tako nujna, da je posvetovanje nemogoče.

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 they communicate to the network, pursuant to Article 4, is promptly forwarded to all other participating structures/authorities and the Commission.

3. Ko mora država članica zaradi nujnosti sprejeti ukrepe za obvladovanje zaradi pojava ali ponovnega pojava nalezljivih bolezni, kolikor hitro je mogoče prek mreže Skupnosti obvesti ostale države članice in Komisijo.

V ustrezno upravičenih posebnih primerih lahko države članice, ki to želijo, sprejmejo ustrezne preventivne in zaščitne ukrepe, sprejete z obojestranskim sporazumom med državami članicami v sodelovanju s Komisijo.

Article 6

4. Države članice se na podlagi posvetovanj in razpoložljivih informacij med seboj usklajujejo v povezavi s Komisijo glede ukrepov, ki so jih sprejele ali jih nameravajo sprejeti na nacionalni ravni.

1. Member States shall, on the basis of the information available through the Community network, consult each other in liaison with the Commission with a view to coordinating their efforts for the prevention and control of communicable diseases.

5. Postopki, ki se nanašajo na informacije in posvetovanja iz odstavkov 1, 2 in 3 in na postopke glede usklajevanja iz odstavkov 1 in 4 se določijo v skladu s postopkom, določenim v členu 7.

2. Where a Member State intends to adopt measures for the control of communicable diseases, it shall, before adopting those measures, inform the other Member States and the Commission on the nature and scope of those measures, through the Community network. The Member State in question shall also consult other Member States and the Commission through the Community network on the nature and scope of intended measures unless the need to protect public health is so urgent that consultation proves impossible.

Člen 7

3. Where a Member State has to adopt, as a matter of urgency, control measures in response to the appearance or resurgence of communicable diseases, it shall, as soon as possible, inform through the Community network the other Member States and the Commission.

1. Za namen izvajanja te odločbe Komisiji pomaga odbor, ki ga sestavljajo predstavniki vsake države članice, predseduje pa mu predstavnik Komisije.

In duly justified specific cases, appropriate prevention and protection measures, adopted by mutual agreement among Member States in conjunction with the Commission, may be taken by the Member States which so desire.

2. Predstavnik Komisije predloži odboru osnutek ukrepov, ki naj se sprejmejo. Odbor sprejme svoje mnenje o osnutku v roku, ki ga predsedujoči lahko določi v skladu z nujnostjo zadeve. Mnenje se sprejema z večino, določeno v členu 148(2) Pogodbe v primeru odločb, ki jih mora Svet sprejeti na predlog Komisije. Glasovi predstavnikov držav članic v odboru se ponderirajo na način, določen v navedenem členu. Predsedujoči ne glasuje.

4. Member States shall, on the basis of their consultations and the information provided, coordinate among themselves in liaison with the Commission with regard to the measures which they have adopted, or intend to adopt at national level.

3. (a) Komisija sprejme predvidene ukrepe, če so v skladu z mnenjem odbora.

5. Procedures concerning the information and consultation referred to in paragraphs 1, 2 and 3 and procedures concerning the coordination referred to in paragraphs 1 and 4 shall be established in accordance with the procedure laid down in Article 7.

(b) Če predvideni ukrepi niso v skladu z mnenjem odbora, ali če mnenje ni sprejeto, Komisija Svetu nemudoma predloži predlog o ukrepih, ki naj se sprejmejo. Svet odloča s kvalificirano večino.

Če Svet v treh mesecih od prejema zadeve ne ukrepa, predlagane ukrepe sprejme Komisija.

Article 7

Člen 8

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 Commission.

Priloga se lahko spremeni ali dopolni v skladu s postopkom, določenim v členu 7.

2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. 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.

Člen 9

3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.

Vsaka država članica v šestih mesecih od začetka veljavnosti te odločbe določi strukture in/ali organe iz drugega in tretjega odstavka člena 1 in o tem obvesti Komisijo in druge države članice. Strukture in/ali organi, ki so bili na ta način določeni, države članice v javnosti opisujejo kot sestavni del mreže Skupnosti, vzpostavljene s to odločbo.

(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 to the measures to be taken. The Council shall act by a qualified majority.

Člen 10

If within three months of the matter being referred to it the Council has not acted, the proposed measures shall be adopted by the Commission.

Za namen te odločbe pristojni organi držav članic in Komisija pospešujejo sodelovanje z državami nečlanicami in mednarodnimi organizacijami, pristojnimi na področju javnega zdravja, predvsem s Svetovno zdravstveno organizacijo.

Člen 11

Article 8

Ta odločba se uporablja, ne da bi posegala v Direktivi 92/117/EGS in 95/46/ES.

The Annex may be amended or supplemented in accordance with the procedure laid down in Article 7.

Člen 12

1. Ta odločba ne vpliva na pravico držav članic, da ohranijo ali uvedejo druge načine, postopke ali ukrepe v svoje državne sisteme za epidemiološko spremljanje in obvladovanje nalezljivih bolezni.

Article 9

2. Ta odločba ne vpliva na pravice in obveznosti držav članic, ki izvirajo iz obstoječih ali bodočih dvostranskih in večstranskih dogovorov ali konvencij na področju te odločbe.

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 the Commission and the other Member States thereof. The structures and/or authorities which have been so designated shall be described in public by the Member States as forming part of the Community network established by this Decision.

Člen 13

Komisija s pomočjo držav članic zagotavlja doslednost in skladnost med to odločbo in ustreznimi programi in pobudami Skupnosti, vključno s tistimi v zvezi z dejavnostmi na področju javnega zdravja, in še posebej okvirnim programom za statistične informacije, projekte na področju telematske izmenjave podatkov med upravami in okvirnim programom za raziskovanje in tehnološki razvoj, zlasti telematskih uporab slednjega programa.

Article 10

Člen 14

For the purposes of this Decision, the competent authorities of the Member States and the Commission shall foster cooperation with non-member countries and international organisations competent in the field of public health, in particular the World Health Organisation.

1. Komisija Evropskemu parlamentu in Svetu predloži redna poročila, v katerih ocenjuje delovanje mreže Skupnosti.

2. V prvem poročilu, ki se predloži v treh letih po začetku veljavnosti te odločbe, se predvsem izpostavijo tisti elementi mreže Skupnosti, ki jih je treba izboljšati ali prilagoditi. Vključuje tudi vse predloge, za katere Komisija meni, da so potrebni za spremembo ali prilagoditev odločbe.

Article 11

3. Komisija zatem ocenjuje mrežo Skupnosti vsakih pet let, s tem da posebno pozornost posveča strukturni zmogljivosti in učinkovitosti uporabe virov ter predloži poročilo Evropskemu parlamentu in Svetu.

This Decision shall apply without prejudice to Directives 92/117/EEC and 95/46/EC.

Člen 15

Ta odločba začne veljati 3. januarja 1999.

Article 12

Člen 16

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.

Ta odločba je naslovljena na države članice.

2. This Decision shall not affect Member States' rights and obligations deriving from existing or future bilateral or multilateral agreements or conventions in the field covered by this Decision.

V Bruslju, 24. septembra 1998

Article 13

Za Evropski parlament

The Commission, with the help of the Member States, shall ensure that there is consistency and complementarity between this Decision and the relevant Community programmes and initiatives, including those in the context of public health action as well as, in particular, the framework programme for statistical information, projects in the field of telematic interchange of data between administrations and the framework programme for research and technological development, especially the telematics applications of the latter programme.

Predsednik

J. M. Gil-robles

Article 14

Za Svet

1. The Commission shall submit regular reports evaluating the operation of the Community network to the European Parliament and the Council.

Predsednik

2. The first report, which shall be submitted within three years after the entry into force of this Decision shall, in particular, identify those elements of the Community network which should be improved or adapted. It shall also include any proposal that the Commission considers necessary for the amendment or adaptation of this Decision.

J. Farnleitner

3. The Commission shall conduct an evaluation of the Community network every five years thereafter, paying particular attention to its structural capacity and effective use of resources, and shall submit a report to the European Parliament and the Council.

[1] UL C 123, 26.4.1996, str. 10 inUL C 103, 2.4.1997, str. 11.

[2] UL C 30, 30.1.1997, str. 1.

Article 15

[3] UL C 337, 11.11.1996, str. 67.

This Decision shall enter into force on 3 January 1999.

[4] Mnenje Evropskega parlamenta z dne 13. novembra 1996 (UL C 362, 2.12.1996, str. 111), Skupno stališče Sveta z dne 22. julija 1997 (UL C 284, 19.9.1997, str. 10) in Sklep Evropskega parlamenta z dne 14. januarja 1998 (UL C 34, 2.2.1998, str. 70). Sklep Evropskega parlamenta z dne 15. julija 1998 (UL C 292, 21.9.1998). Sklep Sveta z dne 20. julija 1998.

[5] UL C 329, 6.12.1993, str. 375.

Article 16

[6] UL C 165, 17.6.1994, str. 1.

This Decision is addressed to the Member States.

[7] UL C 15, 18.1.1994, str. 6.

[8] UL C 326, 11.12.1992, str. 1.

Done at Brussels, 24 September 1998.

[9] UL L 95, 16.4.1996, str. 16.

For the European Parliament

[10] UL L 62, 15.3.1993, str. 38.

The President

[11] UL L 281, 23.11.1995, str. 31.

J. M. GIL-ROBLES

[12] UL L 269, 11.11.1995, str. 23.

For the Council

[13] UL C 102, 4.4.1996, str. 1.

The President

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J. FARNLEITNER

PRILOGA

SEZNAM VRST NALEZLJIVIH BOLEZNI

(1) OJ C 123, 26. 4. 1996, p. 10 and

- Bolezni, ki jih je mogoče preprečiti s cepljenjem

OJ C 103, 2. 4. 1997, p. 11.

- Spolno prenosljive bolezni

(2) OJ C 30, 30. 1. 1997, p. 1.

- Virusni hepatitis

(3) OJ C 337, 11. 11. 1996, p. 67.

- Bolezni, prenosljive s hrano

(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 July 1998 (OJ C 292, 21. 9. 1998). Council Decision of 20 July 1998.

- Bolezni, prenosljive z vodo in bolezni, ki izvirajo iz okolja

(5) OJ C 329, 6. 12. 1993, p. 375.

- Bolnišnične okužbe

(6) OJ C 165, 17. 6. 1994, p. 1.

- Druge bolezni, prenosljive z nekonvencionalnimi povzročitelji (vključno s Creutzfeldt-Jakobovo boleznijo)

(7) OJ C 15, 18. 1. 1994, p. 6.

- Bolezni, ki jih obravnavajo mednarodni zdravstveni predpisi (rumena mrzlica, kolera in kuga)

(8) OJ C 326, 11. 12. 1992, p. 1.

- Druge bolezni (steklina, tifus, virusne hemoragične mrzlice, malarija in katera koli druga do sedaj nerazvrščena huda bolezen, ki se pojavlja v epidemijah, itd.)

(9) OJ L 95, 16. 4. 1996, p. 16.

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(10) OJ L 62, 15. 3. 1993, p. 38.

(11) OJ L 281, 23. 11. 1995, p. 31.

(12) OJ L 269, 11. 11. 1995, p. 23.

(13) OJ C 102, 4. 4. 1996, p. 1.

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 Creutzfeldt-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, etc.).

Commission statement

The Commission will take particular care to set up, in the light of the resources available, a clearly identified structure with sufficient staff to ensure application of the Decision.