CELEX: 51997PC0031
Language: en
Date: 1997-02-03
Title: Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DECISION creating a network for the epidemiological surveillance and control of communicable diseases in the European Community

COMMISSION OF THE EUROPEAN COMMUNITIES
                                       Brussels, 03.02.1997
                                       COM(97)31 final
                                       96/ 0052 (COD)
                    Amended proposal for a
 EUROPEAN PARLIAMENT AND COUNCIL DECISION
      creating a network for the epidemiological surveillance
and control of communicable diseases in the European Community
 (presented by the Commission pursuant to Article 189 a (2)
                       of the EC-Treaty)
 ---pagebreak---  ---pagebreak---                               EXPLANATORY MEMORANDUM
  Amended proposal for a European Parliament and Council Decision creating a network
  for the epidemiological surveillance and control of communicable diseases in the European
  Community
IThe initial proposal for a European Parliament and Council Decision was adopted on
          7 March 1996.
2 The Economic and Social Committee1 and the Committee of the Regions2 have delivered
          favourable opinions on this initial proposal from the Commission.
3 In the light of the opinion delivered by the European Parliament at first reading on
          13 November 1996, an amended proposal for a Decision has been submitted by
          the Commission in accordance with Article 189a, paragraph 2, of the EC Treaty.
          The amended text incorporates those of the Parliament's amendments which the
          Commission considered acceptable, either with changes to the wording in order to
          ensure clarity or exactly as transmitted by Parliament. The objective of these
          amendments is merely to improve comprehension and the mode of operation of the
          future surveillance and control network.
4 At the vote of 19 November 1996, the European Parliament adopted 17 amendments. The
          Commission considers 12 of these to be acceptable, either in their entirety (Nos 9,
          13, 14, 16 and 17) or in part (Nos 1, 2, 4, 5, 6, 12 and 16).
5 The amendments which were not acceptable to the Commission are as follows:
          -       No 3 (inconsistent with the wording of the EC Treaty)
          -       Nos 7, 10 and 11 (additions with no legal significance)
          -        No 8 (unacceptable financial and political consequences).
  1
           Opinion delivered on 25 September 1996 (Doc. CES 1068/96)
  2
          Opinion delivered on 13 June 1996 (Doc. CdR 157/96)
                                                   2^3
 ---pagebreak---                COM (96) 78 final                   AMENDED PROPOSAL
 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
 Commission1,
Having regard to the opinion of the Economic
and Social Committee2,
Having regard to the opinion of the Committee of
the Regions3,
 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, invited the Commission to set up a
trans-frontier network to devise working
definitions of notifiable diseases, to collect,
update, analyse 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 health5 the Council agreed that priority
should be given at present to communicable
diseases in particular;
4 - Whereas in its conclusions of 13 December
19936, 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;
        OJ No C 123, 26.4.1996, p. 10.
        OJNo...
        OJNo...
        OJ No C 329, 6.12.1993, p. 375.
        OJNoC165, 17.6.1994, p. 1.
        OJNoC 15, 18.1.1994, p. 6.
 ---pagebreak---  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
 health1, 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
  19922, 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;
          COM(93) 559 final, 24.11.1993.
          OJNoC326, 11.12.1992, p. I.
 ---pagebreak---                                                    9a - Whereas the constantly growing needs of the
                                                   structures which, in the Member States, are
                                                   responsible for the epidemiological surveillance
                                                   of communicable diseases make it necessary to
                                                   establish, at Community level, a permanent
                                                   structure to respond to those needs:
 10 - Whereas measures in the health field must    10 - Whereas measures to be taken in the health
 take into account other actions undertaken by the field must take into account other actions
 Community in the field of public health or which  undertaken by the Community in the field of
 have an impact on public health;                  public health or which have an impact on public
                                                   health;
 11 - Whereas European Parliament and Council
Decision 647/96/EC adopting a programme of
Commumty 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 Commumty 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 organisations, 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    14 - Whereas the emergence or recent resurgence
of serious communicable diseases has               of serious communicable diseases has
demonstrated that when an emergency situation      demonstrated that when an emergency situation
occurs all relevant information must be            occurs all relevant data and information must be
communicated swiftly to the Commission in an       communicated swiftly to the Commission in an
agreed form of presentation;                       agreed form of presentation and using appropriate
                                                   methods;
 15 - Whereas the introduction of specific         15 - Whereas in order to ensure protection of the
 Community arrangements will help to ensure that   population in an emergency, the Community
 all Member States are swiftly informed in the     network must be in a position to communicate
 event of such an emergency situation, so that the relevant data and information to all Member
 protection of the population can be ensured;      States without delay:
         OJ No L 95, 16.4.1996, p. 16.
 ---pagebreak--- 16 - Whereas the provisions of Council Directive
92/117/EEC1 of 17.12.93 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 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) 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;
                                                    18a - Whereas consideration must be given to the
                                                    efforts deployed with a view to encouraging
                                                    international cooperation in this field,
                                                    particularly as part of the joint plan of action
                                                    with the United States aiming at establishing a
                                                    global early warning system and response
                                                    network for 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;
        O J N o L 6 2 , 15.3.1993, p. 38.
        O J N o L 2 6 9 , 11.11.1995, p.23.
 ---pagebreak---  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:
                                                    1 - epidemiological surveillance: the ongoing
 1 - epidemiological surveillance: the ongoing      systematic collection, analysis, interpretation and
systematic collection, analysis, interpretation and dissemination of comparable and compatible
dissemination of health data concerning             health data concerning communicable diseases,
communicable diseases, for the purpose of           for the purpose of enabling appropriate counter-
enabling appropriate counter-measures to be         measures to be taken;
taken;
    2 - 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;
 ---pagebreak---  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 Commission representative shall submit to
the committee a draft of the measures to be taken.    the committee a draft of the measures to be taken.
The committee shall deliver its opinion on this       The committee shall deliver its opinion on this
draft within a time limit which the chairman shall    draft within a time limit which the chairman may
lay down according to the urgency of the matter.      lav down according to the urgency of the matter.
The opinion shall be delivered by the majority       The opinion shall be delivered by the majority
laid down in Article 148(2) of the Treaty in the      laid down in Article 148(2) of the Treaty in the
case of decisions which the Council is required to   case of decisions which the Council is required to
adopt on a proposal from the Commission. The         adopt on a proposal from the Commission. The
votes of the representatives of the Member States    votes of the representatives of the Member States
within the committee shall be weighted in the        within the committee shall be weighted in the
manner set out in that Article. The chairman shall   manner set out in that Article. The chairman shall
not vote.                                            not vote.
The Commission shall adopt the measures              The Commission shall adopt the measures
envisaged if they are in accordance with the         envisaged where they are in accordance with the
opinion of the committee. If the measures            opinion of the committee. If the measures
envisaged are not in accordance with the opinion     envisaged are not in accordance with the opinion
of the committee, or if no opinion has been          of the committee, or if no opinion has been
delivered, the Commission shall forthwith submit     delivered, the Commission shall without delay
to the Council a proposal concerning the             submit to the Council a proposal concerning the
measures to be taken. The Council shall act by a     measures to be taken. The Council shall act by a
qualified majority.                                  qualified majority.
If, within three months of the matter being          If, within three months of the matter being
referred to it, the Council has not adopted          referred to it, the Council has not acted, the
measures, the Commission shall adopt the             measures proposed shall be adopted by the
measures proposed and implement them                 Commission.
immediately.
Article 5
The measures referred to in Article 4 concern in
particular:
1 - case definitions, in particular the clinical     1 - case definitions, in particular the clinical
definition and, where appropriate, the               definition and, wherever possible, the
microbiological characterisation of the agent        microbiological characterisation of the agent
responsible;                                         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;
                                                   10
 ---pagebreak--- 3 - the epidemiological and microbiological
surveillance methods;
4 - the protective measures to be taken, in            4 - the protective measures to be taken, in
particular at ports and airports, notably in           particular at external borders, notably in
emergency situations;                                 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 Commumty 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 6a:
                                                      The Community network shall, without delay,
                                                      transmit to the competent authorities of the
                                                      Member States the information referred to in
                                                      Articles 5 and 6. together with any information it
                                                      might have on any emergency resulting from the
                                                      appearance or resurgence of cases of serious
                                                      communicable diseases in the territory of the
                                                      European Community or from third countries.
                                                      Article 6b:
                                                      The Community network shall be subject to a
                                                      periodical assessment, giving rise to a report,
                                                      every five years, from the Commission to the
                                                      European Parliament and the Council, analysing
                                                      in particular the use of all types of resources
                                                      allocated to the network and the capacity of the
                                                      network to carry out the tasks assigned to it.
                                                    11
 ---pagebreak---  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              The Annex may be amended or supplemented in
 Annex in accordance with the procedure provided         accordance with the procedure provided for in
 for in Article 4.                                       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 1Î
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.
Done at Brussels
For the European Parliament         For the Council
The President                     The President
                                                      12
 ---pagebreak---  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:
Ï - diseases covered by the International Health
Regulations (yellow fever, cholera, plague)
2 - other diseases (smallpox, rabies, typhus fever,
African haemorrhagic fevers, malaria and any
other as yet unclassified serious epidemic disease,
etc.).
                                                     13
 ---pagebreak---  ---pagebreak---                                                                    ISSN 0254-1475
                                                             COM(97) 31 final
                                             DOCUMENTS
EN                                                                        05 15
                                    Catalogue number : CB-CO-97-028-EN-C
                                                              ISBN 92-78-15256-0
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