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

Id-deċiżjoni Nru 2119/98/KE Tal-Parlament Ewropew u tal-Kunsill

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

ta' l-24 ta' Settembru 1998

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

dwar l-istabbiliment ta' network għas-sorveljanza epidemoloġika u kontroll ta' mard li jinxtered fil-Komunità

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

IL-PARLAMENT EWROPEW U L-KUNSILL TA' L-UNJONI EWROPEA,

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

Wara li kkunsidraw it-Trattat li jistabbilixxi l-Komunità Ewropea, u b'mod partikolari l-Artikolu 129 dwar dan,

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

Wara li kkunsidraw il-proposta mill-Kummissjoni [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,

Wara li kkunsidraw l-opinjoni tal-Kumitat Ekonomiku u Soċjali [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;

Wara li kkunsidraw l-opinjoni tal-Kumitat tar-Reġjuni [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;

Filwaqt li jaġixxu b'mod konformi mal-proċedura stipulata fl-Artikolu 189b tat-Trattat [4], fid-dawl tat-test konġunt approvat mill-Kumitat ta' Konċiljazzjoni tas-27 ta' Mejju 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) Billi l-prevenzjoni tal-mard, b'mod partikolari tal-problemi maġġuri tas-saħħa, hija prijorità għall-azzjoni fil-Komunità, li tirrikjedi approċċ globali koordinat bejn l-Istati Membri.

(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) Billi l-Parlament Ewropew, fir-riżoluzzjoni tiegħu dwar il-politika tas-saħħa pubblika wara Maastricht [5], stieden lill-Kummissjoni biex tistabbilixxi network trans-konfini biex jinħolqu definizzjonijiet li jaħdmu ta' mard notifikabbli, biex tinġabar, tiġi aġġornata, tiġi analizzata u tixxerred l-informazzjoni ta' l-Istati Membri dwar dan il-mard u biex jaħdmu ma' aġenziji nazzjonali u internazzjonali fuq dawn il-kwistjonijiet.

(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) Billi fir-reżoluzzjoni tiegħu tat-2 ta' Ġunju 1994 [6] fil-qafas għal azzjoni fil-Komunità fil-qasam tas-saħħa pubblika l-Kunsill qabel li fil-preżent għandha tingħata prijorità partikolarment lill-mard li jinxtered.

(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) Billi fil-konklużjonijiet tat-13 ta' Diċembru 1993 [7] il-Kunsill ikkunsidra li kien hemm bżonn li tiġi żżviluppata fuq livell ta' Komunità network għas-sorveljanza u l-kontroll ta' mard komunikabbli, li l-għan ewlieni tiegħu jkun li jiġbor u jikkoordina l-informazzjoni minn networks ta' monitoraġġ fl-Istati Membri.

(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) Billi f'dawk l-istess konklużjonijiet il-Kunsill talab lill-Kummissjoni biex tagħti attenzjoni speċjali, fil-proposta tagħha rigward il-qafas għal azzjoni fil-qasam ta' saħħa pubblika, lill-istabbiliment ta' network epidemoloġiku fil-Komunità, filwaqt li jitqiesu l-proċeduri u l-mekkaniżmi attwali li jeżistu fl-livell tal-Komunità u fl-Istati Membri, u li tassigura l-paragunabilità u l-kompatibilità tad-data.

(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) Billi fir-resoluzzjoni tat-13 ta' Novembru 1992 dwar il-monitoraġġ u s-sorveljanza ta' mard li jinxtered fil-Komunità [8], il-Kunsill u l-Ministri tas-Saħħa, f'laqgħa fil-Kunsill, issottolinjaw ix-xewqa li jtejbu, fi ħdan il-Komunità, l-użu u l-effett ta' networks eżistenti bejn l-Istati Membri għas-sorveljanza ta' mard komunikabbli (inkluż n-networks tal-ipproċċessar tad-data), kif ukoll ix-xewqa li tinżamm, tiġi stabbilita jew tissaħħaħ il-koordinazzjoni bejniethom għall-monitaraġġ ta' tixrid tal-mard komunikabbli, meta din l-azzjoni tista iżżid mal-valur ta' miżuri eżistenti.

(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) Billi f'dik l-istess riżoluzzjoni, il-Kunsill u l-Ministru tas-Saħħa, fl-laqgħa mal-Kunsill, issottolinea l-bżonn tal-ġbir tad-data mill-Istati Membri fuq kull numru limitat ta' mard serju u rari li jirrikjedi kampjuni kbar għal-studju epidemoloġiku.

(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) Billi f'dik l-istess riżoluzzjoni l-Kunsill u l-Ministru tas-Saħħa, waqt laqgħa mal-Kunsill, stieden lill-Kummissjoni biex teżamina x-xewqa li tingħata prijorità lil ċerti proposti xierqa rigward il-kontroll u s-sorveljanza tal-mard ta' tixrid, fid-dawl ta', inter alia, l-effettività fl-infiq stmat.

(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) Billi, skond il-prinċipju ta' sussidjarjetà, kull miżura meħuda f'kull qasam li ma jaqax taħt il-kompetenza esklussiva tal-Komunità, bħas-sorveljanza epidemoloġika u l-kontroll tal-mard komunikabbli, jista' jittieħdu mill-Komunità biss jekk, b'raġuni ta' l-iskala jew effetti ta' l-azzjoni proposta, l-għanijiet ta' l-azzjoni proposta jistgħu jkunu miksuba b'mod aħjar mill-Komunità milli mill-Istati Membri.

(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) Billi l-livelli varjanti u bżonnijiet ta' sorveljanza epidemoloġika ta' mard komunikabbli fl-Istati Membri jagħmluha neċessarja li jkun stabbilit network permanenti fuq il-livell tal-Komunità.

(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) Billi l-miżuri li għandhom jittieħdu fil-qasam tas-saħħa għandhom iqisu azzjonijiet oħra li ttieħdu mill-Komunità fil-qasam ta' saħħa pubblika jew li għandhom impatt fuq is-saħħa pubblika.

(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) Billi l-miżuri li għandhom jittieħdu skond din id-Deċiżjoni huma adottati u jeskludu kull armonizzazzjoni tal-liġijiet u regoli ta' l-Istati Membri.

(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) Billi d-Deċiżjoni 647/96/KE tal-Parlament Ewropew u tal-Kunsill tad-29 ta' Marzu 1996 li tadotta kull programm ta' azzjoni tal-Komunità dwar il-prevenzjoni ta' l-AIDS u ċertu mard ieħor li jinxtered fi ħdan il-qafas għal azzjoni fil-qasam tas-saħħa pubblika (1996 sa 2000) [9] tipprevedi numru ta' azzjonijiet tal-Komunità għall-ħolqien u żvilupp ta' networks għall-kontroll u sorveljanza ta' ċertu mard li jinxtered, l-għarfien kmieni ta' dan il-mard, u l-inkorraġiment ta' taħriġ ta' epidemoloġisti tal-lok f'dan il-qasam.

(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) Billi l-kooperazzjoni ma' l-organizzazzjonijiet internazzjonali kompetenti, b'mod partikolari l-Organizzazjoni Dinjija tas-Saħħa, dwar il-klassifikazzjoni tal-mard, għandha tinżamm, kif ukoll l-użu tal-lingwa u tat-teknoloġija xierqa.

(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) Billi l-kooperazzjoni ma' pajjiżi li mhumiex membri, b'mod partikolari fil-każ tad-dehra jew l-irxoxtar ta' mard li jinxtered serju, għandu jiġu appoġġat.

(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) Billi l-apparenza riċenti jew id-dehra mill-ġdid ta' mard serju li jinxtered wera li meta jkun hemm sitwazzjoni ta' emerġenza l-informazzjoni u d-data meħtieġa kollha miġbura skond metodoloġija miftehma għandha tiġi kkomunikata minnufih lill-Kummissjoni.

(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) Billi, biex jassiguraw il-ħarsien tal-popolazzjoni f'każ ta' emergenza, l-Istati Membri għandhom immedjatament jiskambjaw id-data u l-informazzjoni meħtieġa permezz tan-network tal-Komunità; billi għandha tingħata prijorità għal ħarsien tas-saħħa pubblika.

(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) Billi d-Direttiva tal-Kunsill 92/117/KEE tas-17 ta' Diċembru 1992 dwar miżuri għall-ħarsien kontra żonosi speċifiċi u aġenti żoonotiċi speċifiċi f'annimali u prodotti ta' oriġini ta' l-annimali sabiex tipprevieni l-feġġ ta' infezzjonijiet u intossikazzjonijiet [10] meħuda mill-ikel tapplika ugwalment għall-informazzjoni rigward iż-żonosi li taffetwa l-bnedmin; billi l-istess Direttiva tipprovdi wkoll għal kull sistema ta' ġbir u tixrid ta' informazzjoni dwar zoonosi speċifiċi u aġenti żonotiċi speċifiċi.

(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) Billi l-istabbiliment ta' kull network għas-sorveljanza epidemoloġika u l-kontroll ta' mard li jinxtered fuq il-livell tal-Komunità neċessarjament jippresupponi konformità ma' dispożizzjonijiet legali rigward il-protezzjoni ta' l-individwi fil-qasam ta' l-ipproċessar ta' data personali u l-introduzzjoni ta' arranġamenti li jigġarantixxu l-konfidenzjalità u s-sigurtà ta' din l-informazzjoni; billi f'din il-konnesjoni l-Parlament Ewropew u l-Kunsill addottaw id-Direttiva 95/46/KE [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) Billi l-proġetti tal-Komunità fil-qasam ta' l-iskambju telematiku ta' data bejn l-amministrazzjonijiet (IDA) [12] u l-proġetti tal-G7 għandhom ikunu kkoordinati mill-qrib bl-implimentazzjoni ta' l-azzjonijiet tal-Komunità rigward is-sorveljanza epidemoloġika u l-kontroll ta' mard komunikabbli.

(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) Billi għandha tingħata konsiderazzjoni lill-isforzi magħmula bil-għan li tiġi inkoraġġuta l-kooperazzjoni internazzjonali f'dan il-qasam, b'mod partikolari bħala parti ta' pjan ta' azzjoni konġunt ma' l-Istati Uniti.

(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) Billi huwa importanti, f'każ ta' kull emerġenza, li l-istrutturi nazzjonali kompetenti u/jew l-awtoritajiet għandhom isaħħu l-kooperazzjoni tagħhom, b'mod partikolari rigward l-identifikazzjoni ta' kampjuni bioloġiċi.

(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) Billi l-proċeduri tal-Komunità li jistgħu jitwaqqfu għal iskambju ta' informazzjoni magħmul bil-ħeffa ma jaffetwax id-drittijiet u d-doveri ta' l-Istati Membri taħt patti ta' ftehim u konvenzjonijiet bilaterali jew multilaterali.

(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) Billi għandha tiġi stabbilita kull proċedura li tinkoraġġixxi l-koordinazzjoni bejn l-Istati Membri rigward miżuri li jistgħu jiddeċiedu li jieħdu biex jikkontrollaw il-firxa ta' mard li jinxtered; billi l-adozzjoni u l-implimentazzjoni ta' dawn il-miżuri jaqgħu taħt il-kompetenza esklussiva ta' l-Istati Membri.

(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) Billi huwa importanti li l-Kummisjoni għandha timplimenta n-network tal-Komunità b'kooperazzjoni mill-qrib ma' l-Istati Membri; billi għalhekk għandha tiġi stabbilita proċedura biex tiżgura l-parteċipazzjoni sħiħa ta' l-Istati Membri f'din l-implimentazzjoni.

(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) Billi l-ispejjeż li jistgħu jirriżultaw mill-ħidma tan-network fuq livell tal-Komunità għandhom jiġu pprovdut minn riżorsi tal-Komunità u/jew minn programmi rilevanti tal-Komunità.

HAVE ADOPTED THIS DECISION:

(27) Billi l-ispejjeż li jistgħu jirriżultaw mill-operazzjoni tan-network għandhom jiġu ffinanzjati mill-Istati Membri nfushom, sakemm id-dispożizzjonijiet tal-Komunità ma jipprovdux mod ieħor.

(28) Billi kull modus vivendi bejn il-Parlament Ewropew, il-Kunsill u l-Kummissjoni dwar il-miżuri ta' implimentazzjoni għal atti adottati b'mod konform mal-proċedura stabbilita fl-Artikolu 189b tat-Trattat [13] intlaħaq fl-20 ta' Diċembru 1994,

ADOTTAW DIN ID-DEĊIŻJONI:

Article 1

L-Artikolu 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:

L-iskop ta' din id-Deċiżjoni huwa li jiġi stabbilit kull network fuq livell tal-Komunità li jħeġġeġ il-kooperazzjoni u l-koordinazzjoni bejn l-Istati Membri, bl-assistenza tal-Kummissjoni, bil-għan li jittejbu l-prevenzjoni u l-kontroll, fil-Komunità, tal-kategoriji ta' mard li jinxtered u li huma speċifikati fl-Anness. Dan in-network għandu jintuża għal:

- the epidemiological surveillance of these diseases, and

- sorveljanza epidemoloġika ta' dan il-mard, u

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

- sistema ta' twissija bikrija u ta' rispons għall-prevenzjoni u l-kontroll ta' dan il-mard.

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.

Rigward is-sorveljanza epidemoloġika, in-network għandu jiġi stabbilit billi jinġiebu f'komunikazzjoni permanenti ma' xulxin, permezz ta' kull mezz tekniku xieraq, il-Kummissjoni u dawk l-istrutturi u/jew awtoritajiet li, fuq il-livell ta' kull Stat Membru u taħt ir-risponsabbiltà ta' dak l-Istat Membru, huma kompetenti fuq livell nazzjonali u li xogħolhom huwa li jiġbru l-informazzjoni relatata mas-sorveljanza epidemoloġika tal-mard li jinxtered, u billi jistabbilixxu proċeduri għat-tixrid tas-sorveljanza relevanti tad-data fuq livell tal-tal-Komunità.

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.

Rigward is-sistema ta' twissija bikrija u sistema ta' rispons, dan in-network għandu jiġi stabbilit billi jiġi fis-seħħ sistema ta' komunikazzjoni permanenti ma xulxin, permezz ta' mezzi tekniċi xierqa, il-Kummissjoni u l-awtoritajiet tas-saħħa kompetenti f'kull Stat Membru risponsabbli biex jistabbilixxi l-miżuri li jistgħu jkunu meħtieġa biex tista' tiġi mħarsa s-saħħa pubblika.

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

Il-Kummissjoni għandha tipprovdi għall-koordinazzjoni tan-network b'kollaborazzjoni ma' l-Istati Membri.

L-Artikolu 2

Article 2

Għall-iskop ta' din id-Deċiżjoni, it-termini li ġejjin għandhom ikollhom it-tifsiriet li ġejjin:

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

1. "sorveljanza epidemoloġika": il-ġbir, analiżi, interpretazzjoni, u t-tixrid ta' data dwar is-saħħa kontinwu u sistematiku, inklużi l-istudji epidemoloġiċi, rigward il-kategoriji ta' mard li jixtered imniżżel fl-Anness, b'mod partikolari l-mod ta' tixrid ta' dan il-mard matul ż-żmien u spazju u l-analiżi tal-fatturi ta' riskju għat-teħid ta' dan il-mard, bil-għan li jittieħdu miżuri ta' prevenzjoni xierqa kif ukoll kontra-miżuri xierqa;

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. "il-prevenzjoni u kontroll ta' mard li jinxtered": il-firxa ta' miżuri, inklużi l-investigazzjonijiet epidemoloġiċi, meħuda mill-awtoritajiet tas-saħħa pubblika kompetenti fl-Istati Membri biex jipprevienu u jwaqqfu x-xerda ta' mard komunikabbli;

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. "network tal-Komunità": network għas-sorveljanza epidemoloġika u għal kontroll ta' mard li jinxtered, jiġifieri s-sistema li permezz tagħha l-informazzjoni meħtieġa biex isiru l-attivitajiet li għalihom saret referenza fil-punti 1 u 2 hija skambjata.

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.

L-Artikolu 3

Bil-għan li jkun hemm ħidma effettiva ta' network tal-Komunità rigward is-sorveljanza epidemoloġika u li tiġi miksuba informazzjoni uniformi fi ħdan dan il-qafas, li ġejjin għandhom jiġu stabbiliti skond il-proċedura stabbilita fl-Artikolu 7:

Article 3

(a) il-mard li jinxtered għandu jiġi progressivament kopert taħt in-network tal-Komunità;

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) il-kriterji għall-għażla ta' dan il-mard, wara li kkunsidraw il-kategoriji mniżżla fl-Anness u n-networks kollaborattivi li jeżistu għas-sorveljanza tal-mard li jistgħu jittejbu;

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

(ċ) definizzjonijiet skond il-kas, b'mod partikolari karateristiċi kliniki u mikrobioloġiċi;

(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) in-natura u t-tip ta' data u informazzjoni li għandha tiġi miġbura u trasmessa bl-istrutturi u/jew l-awtoritajiet li għalihom saret referenza fit-tieni paragrafu ta' l-Artikolu 1 fil-qasam ta' sorveljanza epidemoloġika u l-mezzi li bihom din id-data għandhom ikunu mqabbla u kompatibbli;

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

(e) metodi ta' sorveljanza epidemoloġiċi u mikrobijoloġiċi;

(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) linji ta' gwida ġenerali dwar il-miżuri protettivi li għandhom jittieħdu, b'mod partikolari fil-fruntieri esterni ta' l-Istati Membri, l-aktar f'sitwazzjonijiet ta' emerġenza;

(e) epidemiological and microbiological surveillance methods;

(g) linji gwida dwar l-informazzjoni u gwidi ta' prattika tajba għall-pubbliku;

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

(h) il-mezzi tekniki xierqa u l-proċeduri li bihom id-data għandhom jiġu mxerda u analizzati fuq livell tal-Komunità.

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

L-Artikolu 4

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

Kull struttura u/jew awtorità li għalih saret referenza fit-tieni paragrafu jew fit-tielet paragrafu, skond liema huwa xieraq ta' l-Artikolu 1 għandu jikkomunika lin-network tal-Komunità:

(a) informazzjoni rigward id-dehra jew ir-risurġenza ta' każi ta' mard li jinxtered kif saret referenza għalih fl-Artikolu 3(a) fl-Istat Membru li għalih tappartieni l-istruttura u/jew l-awtorità, flimkien ma' l-informazzjoni dwar il-miżuri ta' kontroll applikati;

Article 4

(b) kull informazzjoni rilevanti rigward il-progress ta' sitwazzjonijiet ta' epidemija li għandha risponsabbiltà għalihom għal ġbir ta' informazzjoni;

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:

(ċ) informazzjoni dwar fenomini epidemiċi mhux tas-soltu jew mard ġdid li jinxtered ta' oriġini mhux magħrufa;

(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) kull informazzjoni rilevanti fil-pussess tagħha:

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

- dwar każi ta' mard li jinxtered kopert mill-kategoriji stabbiliti fl-Anness,

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

- dwar mard ġdid li jinxtered li l-oriġini tiegħu mhix magħrufa f'pajjiżi li mhumiex membri;

(d) any relevant information in its possession:

(e) informazzjoni rigward mekkaniżmi u proċeduri eżistenti u proposti għall-prevenzjoni u kontroll ta' mard li jinxtered, b'mod partikolari f'sitwazzjonijiet ta' emerġenza;

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

(f) kull konsiderazzjoni rilevanti li tista' tkun ta' għajnuna għall-Istati Membri biex jikkoordinaw l-isforzi tagħhom għal prevenzjoni u kontroll tal-mard li jinxtered, inkluż l-kontra-miżuri implimentati.

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

L-Artikolu 5

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

Il-Kummissjoni għandha tagħmel disponibbli l-informazzjoni li għaliha saret referenza fl-Artikolu 3 lill-istrutturi u awtoritajiet li għalihom saret referenza fl-Artikolu 1. Kull struttura/awtorità għandha tiżgura li l-informazzjoni li jikkomunikaw lin-network, skond l-artikolu 4, tingħadda minnufih lill-istrutturi/awtoritajiet parteċipanti u lill-Kummissjoni.

(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.

L-Artikolu 6

1. L-Istati Membri għandhom, skond l-informazzjoni disponibbli min-network tal-Komunità, jikkonsultaw lil xulxin f'liaison mal-Kummissjoni bil-għan li jikkoordinaw l-isforzi tagħhom għall-prevenzjoni u kontroll tal-mard li jinxtered.

Article 5

2. Meta l-Istat Membru għandu l-intenzjoni li jadotta miżuri għall-kontroll għall-mard li jinxtered, għandu, qabel ma jadotta dawn il-miżuri, jinforma l-Istati Membri l-oħra u lill-Kummissjoni dwar in-natura u l-iskop ta' dawk il-miżuri, permezz tan-network tal-Komunità. L-Istati Membri inkwistjoni għandhom jikkonsultaw ukoll lill-Istati Membri l-oħra u lill-Kummissjoni permezz tan-network tal-Komunità dwar in-natura u skop tal-miżuri maħsuba sakemm il-bżonn li tiġi protetta s-saħħa pubblika mhix daqshekk urġenti li l-konsultazzjoni tkun impossibli.

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. Meta kull Stat Membru għandu jaddotta, bħala kas ta' urġenza, miżuri ta' kontroll bħala riżultat ta' l-apparenza jew risurġenza ta' mard li jinxtered, għandu, mill-aktar fis possibli, jinforma lill-Istati Membri l-oħra u l-Kummissjoni permezz tan-network tal-Komunità.

F'każijiet ġustifikati u speċifiċi, u miżuri ta' prevenzjoni xierqa u ta' ħarsien, adottati bi ftehim reċiproku bejn l-Istati Membri flimkien mal-Kummissjoni, jistgħu jittieħdu mill-Istati Membri li jixtiequ dan.

Article 6

4. L-Istati Membri għandhom, fuq il-bażi tal-konsultazzjonijiet u ta' l-informazzjoni provduta, jikkoordinaw bejniethom f'liaison mal-Kummissjoni rigward il-miżuri li adottaw, jew li bi ħsiebhom jadottaw fuq livell nazzjonali.

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. Proċeduri rigward l-informazzjoni u konsultazzjoni li għalihom saret referenza f'paragrafi 1, 2 u 3 u proċeduri rigward il-koordinazzjoni li għalihom saret referenza f'paragrafi 1 u 4 għandhom jiġu stabbiliti skond il-proċedura mniżżla fl-Artikolu 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.

L-Artikolu 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. Bi l-għan li tiġi implimentata din id-Deċiżjoni, il-Kummissjoni għandha tiġi assistita minn kull rappreżentant minn kull Stat Membru u ppreseduta mir-rappreżentant tal-Kummissjoni.

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. Ir-rappreżentant tal-Kummissjoni għandu jissottometti lill-kumitat kull abbozz tal-miżuri li jridu jittieħdu. Il-kumitat għandu jagħti l-fehma tiegħu fl-abbozz f'limitu ta' żmien li l-president jista' jnizzel skond l-urġenza ta' l-affari. Il-fehma għandha tiġi kkonsenjata mill-maġġoranza stabbilita fl-Artikolu 148(2) tat-Trattat fil-każ tad-deċiżjonijiet li l-Kunsill huwa meħtieġ li jadotta kull proposta mill-Kummissjoni. Il-voti tar-rappreżentanti ta' l-Istati Membri fi ħdan il-Kumitat għandhom ikunu peżati skond il-manjiera stabbilita fl-Artikolu. Il-president m'għandux jivvota.

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) Il-Kummissjoni għandha tadotta l-miżuri previsti jekk ikunu konformi mal-fehma tal-kumitat.

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) Jekk il-miżuri previsti mhumiex konformi ma' l-fehma tal-kumitat, jew jekk ma tingħata l-ebda fehma, il-Kummissjoni għandha tissottometti lill-Kunsill mingħajr dewmien kull proposta li jkollha x'taqsam mal-miżuri li jridu jittieħdu. Il-Kunsill għandu jaġixxi b'kull maġġoranza kkwalifikata.

Jekk, fi żmien tliet xhur minn meta l-kwistjoni tiġi riferita lilu, il-Kunsill ma jkunx aġixxa, il-miżuri proposti għandhom jiġu adotti mill-Kummissjoni.

Article 7

L-Artikolu 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.

L-Anness jista jiġi emendat jew tista ssirlu xi żieda skond il-proċedura mniżżla fl-Artikolu 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.

L-Artikolu 9

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

Kull Stat Membru għandu jinnomina, fi żmien sitt xhur mid-dħul fis-seħħ ta' din id-Deċiżjoni, l-istrutturi u/jew awtoritajiet li għalihom saret referenza fit-tieni u fit-tielet paragrafu ta' l-Artikolu 1 u għandu jgħarraf lill-Kummissjoni u l-Istati Membri l-oħra minnufih dwar dan. L-istrutturi u/jew l-awtoritajiet li ġew hekk maħtura għandhom jiġu deskritti fil-pubbliku mill-Istati Membri bħala dawk li jagħmlu parti min-network tal-Komunità imwaqqaf minn din id-Deċiżjoni.

(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.

L-Artikolu 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.

Għall-iskopijiet ta' din id-Deċiżjoni, l-awtoritajiet kompetenti ta' l-Istati Membri u l-Kummissjoni għandhom iħadnu l-kooperazzjoni ma' pajjiżi li mhumiex membri u organizzazzjonijiet internazzjonali li huma kompetenti fil-qasam tas-saħħa pubblika, b'mod partikolari l-Organizzazzjoni Dinjija tas-Saħħa.

L-Artikolu 11

Article 8

Din id-Deċiżjoni għandha tapplika mingħajr preġudizzju għal Direttivi 92/117/KEE u 95/46/KE.

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

L-Artikolu 12

1. Din id-Deċiżjoni m'għandiex taffetwa d-dritt ta' l-Istati Membri li jżommu jew jintroduċu arranġamenti, proċeduri u miżuri oħra għas-sistemi nazzjonali tagħhom għas-sorveljanza epidemoloġika u kontroll tal-mard li jinxtered.

Article 9

2. Din id-Deċiżjoni m'għandiex taffettwa d-drittijiet u d-doveri ta' l-Istati Membri mnissla minn xi ftehim bilaterali jew multilaterali jew konvenzjoni eżistenti u fil-futur jew konvenzjonijiet fil-qasam li jaqgħu taħt din id-Deċiżjoni.

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.

L-Artikolu 13

Il-Kummissjoni, bl-għajnuna ta' l-Istati Membri, għandha tiżgura li jkun hemm konsistenza u kumplimentarjetà bejn din id-Deċiżjoni u l-programmi u inizjattivi relevanti tal-Komunità, inklużi dawk fil-kuntest ta' azzjoni fis-saħħa pubblika kif ukoll, b'mod partikolari, l-programm tal-qafas għall-informazzjoni statistika, proġetti fil-qasam ta' l-iskambju telematiku ta' data bejn l-amministrazzjonijiet u l-programm ta' qafas għar-riċerka u għall-iżvilupp teknoloġiku, speċjalment l-applikazzjonijiet telematiċi tal-programm ta' l-aħħar.

Article 10

L-Artikolu 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. Il-Kummissjoni għandha tagħti rapporti regolari biex tevalwa l-operazzjoni ta' network tal-Komunità lill-Parlament Ewropew u lill-Kunsill.

2. L-ewwel rapport, li għandu jiġi sottomess fi żmien tliet snin mid-dħul fis-seħħ ta' din id-Deċiżjoni għandu, b'mod partikolari, jidentifika dawk l-elementi tan-network tal-Komunità li għandu jiġi mtejjeb jew irranġat. Għandu ukoll jinkludi kull proposta li l-Kummissjoni tikkunsidra neċessarja għall-emenda jew l-adattament ta' din id-Deċiżjoni.

Article 11

3. Il-Kummissjoni għandha treġġi evalwazzjoni tan-network tal-Komunità kull ħames snin wara dan, u tagħti attenzjoni partikolari lill-kapaċità strutturali u l-użu effettiv ta' riżorsi, u għandha tagħti rapport lill-Parlament Ewropew u lill-Kunsill.

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

L-Artikolu 15

Din id-Deċiżjoni għandha tidħol fis-seħħ fit-3 ta' Jannar 1999.

Article 12

L-Artikolu 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.

Dan id-Deċiżjoni hija indirizzata lill-Istati Membri.

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.

Magħmula fi Brussel, fl-24 ta' Settembru 1998.

Article 13

Għall-Parlament Ewropew

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.

Il-President

J. M. Gil-robles

Article 14

Għall-Kunsill

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

Il-President

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] ĠU C 123, tas-26.4.1996, p. 10 uĠU C 103, tat-2.4.1997, p. 11.

[2] ĠU C 30, tat-30.1.1997, p. 1.

Article 15

[3] ĠU C 337, tal-11.11.1996, p. 67.

This Decision shall enter into force on 3 January 1999.

[4] L-opinjoni tal-Parlament Ewropew tat-13 ta' Novembru 1996 (ĠU C 362, tat-2.12.1996, p. 111), il-Pożizzjoni Komuni tal-Kunsill tat-22 ta' Lulju 1997 (ĠU C 284, tad-19.9.1997, p. 10) u d-Deċiżjoni tal-Parlament Ewropew ta' l-14 ta' Jannar 1998 (ĠU C 34, tat-2.2.1998, p. 70). Id-Deċiżjoni tal-Parlament Ewropew tal-15 ta' Lulju 1998 (ĠU C 292, tal-21.9.1998). Id-Deċiżjoni tal-Kunsill ta' l-20 ta' Lulju 1998.

[5] ĠU C 329, tas-6.12.1993, p. 375.

Article 16

[6] ĠU C 165, tas-17.6.1994, p.1.

This Decision is addressed to the Member States.

[7] ĠU C 15, tat-18.1.1994, p. 6.

[8] ĠU C 326, tal-11.12.1992, p. 1.

Done at Brussels, 24 September 1998.

[9] ĠU L 95, tas-16.4. 1996, p. 16.

For the European Parliament

[10] ĠU L 62, tal-15.3.1993, p. 38.

The President

[11] ĠU L 281, tat-23.11.1995, p. 31.

J. M. GIL-ROBLES

[12] ĠU L 269, tal-11.11.1995, p. 23.

For the Council

[13] ĠU C 102, ta' l-4.4.1996, p. 1.

The President

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J. FARNLEITNER

L-ANNESS

LISTA LI TINDIKA L-KATEGORIJI TA' MARD LI JINXTERED

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

- Mard li jista' jiġi pprevenut bit-tilqim

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

- Mard trasmess sesswalment

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

- Epatite virali

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

- Mard ġej mill-ikel

(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.

- Mard ġej mill-ilma u mard ta' oriġini ambjentali

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

- Infezzjonijiet nosokomjali

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

- Mard ieħor li jinxtered minn aġenti li mhumiex konvenzjonali (inkluża l-marda ta' Creutzfeldt-Jakob)

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

- Mard kopert mir-regoli tas-saħħa internazzjonali (id-deni isfar, il-kolera u l-pesta)

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

- Mard ieħor (idrofobja, tifu, deni virali emorarġetiku, malarja u kull mard epidemiku ieħor li għadu ma ġiex ikklassifikat etċ.).

(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.