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
Date: 1997-02-03
Institutions: European Commission
Subjects: EU action, data collection, epidemiology, infectious disease, public health

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 
2 

Opinion delivered on 25 September  1996 (Doc.  CES  1068/96) 
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. 

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; 

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; 

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 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; 

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; 

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. 

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; 

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: 

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, where appropriate,  the 
microbiological  characterisation  of the agent 
responsible; 

1 - case definitions,  in particular  the clinical 
definition  and,  wherever possible,  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; 

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; 

4 - the protective measures to be taken, in 
particular at external  borders, 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. 

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. 

The Annex  may be amended or supplemented  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 
The President 

For  the Council 
The President 

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.). 

13 

ISSN 0254-1475 

COM(97) 31  final 

DOCUMENTS 

EN 

05  15 

Catalogue  number  :  CB-CO-97-028-EN-C 

ISBN 92-78-15256-0 

Office  for  Official  Publications of the European  Communities 

L-2985  Luxembourg 

i H