CELEX: 51996PC0078
Language: en
Date: 1996-03-07
Title: Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DECISION creating a network for the epidemiological surveillance and control of communicable diseases in the European Community

Avis juridique important

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51996PC0078

Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DECISION creating a network for the epidemiological surveillance and control of communicable diseases in the European Community  /* COM/96/0078 FINAL - COD 96/0052 */  

Official Journal C 123 , 26/04/1996 P. 0010

Proposal for a  European Parliament and Council Decision creating a network for the epidemiological surveillance  and control of communicable diseases in the European Community(96/C  123/08)(Text with EEA  relevance)COM(96) 78 final - 96/0052(COD)(Submitted by the Commission on 8 March  1996)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, Having regard to the opinion of the Economic and Social Committee, Having regard to the opinion of the Committee of the Regions, 1. Whereas the prevention of diseases, and in particular of the major health scourges, is a  priority for Community action, requiring a global and coordinated approach between Member States; 2. Whereas the European Parliament, in its resolution on public health policy after Maastricht   (1), invited the Commission to set up a trans-frontier network to devise working definitions of  notifiable diseases, to collect, update, analyze and disseminate Member State data on notifiable  diseases and to work with national and international agencies on these matters; 3. Whereas in its resolution of 2 June 1994 on the framework for Community action in the field of  public health  (2) the Council agreed that priority should be given at present to communicable  diseases in particular; 4. Whereas in its conclusions of 13 December 1993  (3), the Council considers that there is 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; 5. Whereas in these same conclusions the Council requests the Commission to devote special  attention, in its proposals relating to the framework for action in the field of public health   (4), to setting up an epidemiological network in the Community, taking account of current  proceedings and mechanisms existing at Community level and that of Member States, and ensuring the  comparability and compatibility of data; 6. Whereas in their resolution of 13 November 1992  (5), the Council and the Ministers for Health  meeting within the Council underline the desirability of improving, within the Community, the  coverage and effectiveness of existing networks between Member States (including data-processing  networks), and 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; 7. Whereas in this same resolution, the Council and the Ministers for Health meeting within the  Council underline 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; 8. Whereas in this same resolution, the Council and the Ministers for Health meeting within the  Council invite 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; 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 one or more Member States; 10. Whereas measures 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; 11. Whereas European Parliament and Council Decision .  .  ./.  .  ./EC 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 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; 12. Whereas cooperation with the competent international organizations, notably with regard to  disease classification, must be fostered; 13. Whereas cooperation with third countries, notably in the case of the emergence or resurgence of  serious communicable diseases, must be supported; 14. Whereas the emergence or recent resurgence of serious communicable diseases has demonstrated  that when an emergency situation occurs all relevant information must be communicated swiftly to  the Commission in an agreed form of presentation; 15. Whereas the introduction of specific Community arrangements will help to ensure that all Member  States are swiftly informed in the event of such an emergency situation, so that the protection of  the population can be ensured; 16. Whereas the provisions of 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  (1) apply  equally to information concerning zoonoses which affect human beings, and whereas the same  Directive provides for a system for collecting and transmitting information on specified zoonoses  and zoonotic agents; 17. Whereas the setting up of a network for the epidemiological surveillance and control of  communicable diseases at Community level necessarily presupposes observance of 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 and  information; whereas in this connection the European Parliament and the Council adopted Directive  95/46/EC on 24 October 1995; 18. Whereas the Community projects in the field of the telematic interchange of data between  administrations (IDA)  (2) 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; 19. Whereas it is important, in an emergency situation, that the competent national structures  should strengthen their cooperation, notably with regard to the identification of biological  samples; 20. Whereas these Community arrangements for the rapid exchange of information do not affect the  Member States' rights and obligations under Treaties or bilateral and multilateral conventions; 21. 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; 22. Whereas an agreement on a modus vivendi between the European Parliament, the Council and the  Commission concerning measures for the implementation of acts adopted under the procedure laid down  in Article 189b of the Treaty was reached on 20 December 1994, HAVE DECIDED AS FOLLOWS: Article 1 A general network for the epidemiological surveillance and control of  communicable diseases shall be set up in the European Community. This Community network shall be formed by putting into permanent communication with one another,  through all appropriate technical means, structures which, at the level of each Member State and  under the responsibility of the Member State, are charged with collecting information relating to  epidemiological surveillance and coordinating control measures. Article 2 For the purposes of this Decision the following terms shall have the following  meanings: - epidemiological surveillance: the ongoing systematic collection, analysis, interpretation and  dissemination of health data concerning communicable diseases, for the purpose of enabling  appropriate counter-measures to be taken, - control of communicable diseases: the range of measures taken by the competent public health  authorities to stop the spread of communicable diseases, as well as epidemiological studies, in  particular of the pattern of spread of such diseases over time and space and analysis of the risk  factors for contracting such diseases, the results of which enable appropriate preventive measures  to be devised. Article 3 For every Member State, the epidemiological surveillance and control of communicable  diseases at Community level shall apply to: (a) the appearance or resurgence on its territory of cases of serious and/or rare communicable  diseases as listed in the Annex; (b) the importation onto its territory, from another Member State or a non-Community country, of  cases of serious and/or rare communicable diseases as listed in the Annex. Article 4 For the purposes of implementing this Decision the Commission shall be assisted by a  committee consisting of representatives from the Member States and chaired by a representative of  the Commission. The Commission representative shall submit to the committee a draft of the measures to be taken.  The committee shall deliver its opinion on this draft within a time limit which the chairman shall  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 EC 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. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the  committee. If the measures envisaged are not in accordance with the opinion of the committee, or if  no opinion has been delivered, the Commission shall forthwith submit to the Council a proposal  concerning the measures to be taken. The Council shall act by a qualified majority. If, within three months of the matter being referred to it, the Council has not adopted measures,  the Commission shall adopt the measures proposed and implement them immediately. Article 5 The measures referred to in Article 4 concern in particular: 1. case definitions, in particular the clinical definition and, where appropriate, the  microbiological characterisation of the agent responsible; 2. the nature and type of data and information to be collected by the structures referred to in  Article 1 in the field of epidemiological surveillance; 3. the epidemiological and microbiological surveillance methods; 4. the protective measures to be taken, in particular at ports and airports, notably in emergency  situations; 5. information, recommendations and guides to good practice for the public. Article 6 Each structure referred to in Article 1 shall communicate to the Community network and  the Commission: (a) information on the communicable diseases referred to in Article 2, together with information on  control measures applied; (b) any useful information concerning the progression of epidemic situations in the Member State to  which the institution belongs; (c) any evaluation element which will aid cooperation between Member States for the purpose of the  control of communicable diseases, in particular the conservation of biological samples taken from  patients for transmission to specialist laboratories linked to the Community network. Article 7 Each Member State shall appoint, within six months following the entry into force of  this Decision, the structure or structures referred to in Article 1, and shall notify the  Commission thereof. Article 8 The Commission may amend or supplement the Annex in accordance with the procedure  provided for in Article  4. Article 9 This Decision shall apply without prejudice to Council Directive 92/117/EEC 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,  and shall take account of the information collection and transmission procedure provided for in  that Directive. Article 10 This Decision shall apply without prejudice to European Parliament and Council  Directive 95/46/EC on the protection of individuals with regard to the processing of personal data  and on the free movement of such data, and to Council Decision 95/468/EC on a Community  contribution for telematic interchange of data between administrations in the Community (IDA). Article 11 This Decision shall not affect Member States' reciprocal rights and obligations  deriving from existing or future bilateral or multilateral agreements or conventions in the domain  covered by the Decision, and which are in line with the Decision's subject, methods of  implementation and objectives. Article 12 This Decision is addressed to the Member States and shall enter into force three  months after the date of its publication in the Official Journal of the European Communities. (1)  OJ No C 329, 6. 12. 1993, p. 375.  (2)  OJ No C 165, 17. 6. 1994, p. 1.  (3)  OJ No C 15, 18. 1. 1994, p. 6.  (4)  COM(93) 559 final, 24. 11. 1993.  (5)  OJ No C 326, 11. 12. 1992, p. 1.  (1)  OJ No L 62, 15. 3. 1993, p. 38.  (2)  OJ No L 269, 11. 11. 1995, p. 23.   ANNEX The communicable diseases referred to in Article 3 are divided into groups of  serious and/or rare disorders, namely: - concerning paragraph (a): diseases requiring measures to be taken at local level and reported on periodically to the Member  States' public health authorities in accordance with arrangements specific to each of these  diseases and defined in accordance with Article 5, notably: 1. diseases preventable by vaccination (tuberculosis, tetanus, poliomyelitis, diphtheria,  meningitis, measles, mumps, rubella, influenza and influenza syndromes, etc.); 2. sexually-transmitted diseases (hepatitis B, AIDS/HIV, chlamydiasis, etc.); 3. viral hepatitis (including hepatitis C and other as yet unclassified categories of hepatitis); 4. food-borne diseases (listeriosis, salmonellosis, etc.); 5. water-borne diseases and diseases of environmental origin (legionellosis, etc.); 6. nosocomial infections; 7. other diseases transmissible by non-conventional agents (including Creutzfeldt-Jakob disease,  etc.); - concerning paragraph (b)the same diseases as under paragraph (a), plus diseases requiring  exceptional measures to be taken at national and international levels, such as: 1. diseases covered by the International Health Regulations (yellow fever, cholera, plague); 2. other diseases (rabies, typhus fever, African haemorrhagic fevers, malaria and any other as yet  unclassified serious epidemic disease, etc.).