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) 

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 
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. 
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. 
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 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 
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; 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 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; 
14 - Whereas the emergence or recent resurgence 
of serious communicable diseases has 
demonstrated that when an emergency situation 
occurs all relevant data and information must be 
communicated swiftly to the Commission in an 
agreed form of presentation and using appropriate 
methods; 
15 - Whereas in order to ensure protection of the 
population in an emergency, the Community 
network must be in a position to communicate 
relevant data and information to all Member 
States without delay: 
OJ No L 95, 16.4.1996, p. 16. 
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; 
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; 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; 
OJNoL62, 15.3.1993, p. 38. 
OJNoL269, 11.11.1995, p.23. 
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 
systematic collection, analysis, interpretation and 
dissemination of health data concerning 
communicable diseases, for the purpose of 
enabling appropriate counter-measures to be 
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; 1 - epidemiological surveillance: the ongoing 
systematic collection, analysis, interpretation and 
dissemination of comparable and compatible 
health data concerning communicable diseases, 
for the purpose of enabling appropriate counter-
measures to be taken; 
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 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; 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 may 
lav 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. 
The Commission shall adopt the measures 
envisaged where 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 without delay 
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 acted, the 
measures proposed shall be adopted by the 
Commission. 
1 - case definitions, in particular the clinical 
definition and, wherever possible, the 
microbiological characterisation of the agent 
responsible; 
10 
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 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. 4 - the protective measures to be taken, in 
particular at external borders, notably in 
emergency situations; 
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 
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 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 The Annex may be amended or supplemented in 
accordance with the procedure provided for in 
Article 4. 
12 
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.). 
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