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: 1996-03-07
Institutions: European Commission
Subjects: EU action, data collection, epidemiology, infectious disease, public health

' ^1 

COMMISSION  OF THE  EUROPEAN  COMMUNITIES 

Brussels,  07.03.1996 
COM(96)  78 final 

96/0052  (COD) 

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*-#$* 

COMMISSION  COMMUNICATION 

concerning  communicable  disease  surveillance  networks  in  the 
European  Community 

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) 

COMMISSION  COMMUNICATION 

CONCERNING  COMMUNICABLE  DISEASE 

SURVEILLANCE  NETWORKS 

IN THE EUROPEAN  COMMUNITY 

Contents 

I. 

INTRODUCTION: 

H. 

THE  SPECIFIC  NATURE  OF  THE  EPIDEMIOLOGICAL 

SURVEILLANCE  OF  COMMUNICABLE  DISEASES 

1 

2 

3 

4 

5 

D E F I N I T I ON  OF  S U R V E I L L A N CE 

OBJECTIVES  OF  SURVEILLANCE 

PRINCIPLES  AND  METHODS  OF  SURVEILLANCE 

THE  DDJFERENT  SURVEBLLANCE  SYSTEMS 

QUALITY  OF  SURVEILLANCE  SYSTEMS 

HI. 

INTERNATIONAL COLLABORATION PROJECTS IN THE FIELD 

OF DISEASE  SURVEILLANCE 

SYSTEMS  SET  UP  BY  WHO 

SYSTEMS  SUPPORTED  BY  THE  EUROPEAN  COMMUNITY 

OTHER  NETWORKS 

1 

2 

3 

IV.  REVIEW OF THE EXISTING SITUATION AND PROPOSALS FOR 

FUTURE  COMMUNITY  ACTION 

ASSESSMENT  OF THE  EXISTING  SITUATION 

CONCLUSIONS 

1 

2 

FUTURE  ACTIONS 

3 
ANNEX 

1 

3 

2 

3 

4 

4 

5 

6 

7 

8 

9 

12 

13 

13 

15 

16 
19 

L 

INTRODUCTION: 

The  outbreak  of  disease  due  to  the  Ebola  virus  in  Zaire  in  1995,  and  before  that,  the 
epidemic  of  plague in India in  1994 have focused  public attention on the need  to take 
action  against  infectious  diseases.  It  is  a  long-established  fact  that  infectious  diseases 
caused  by  various  microbial  agents  tend  to  spread  through  populations  irrespective  of 
borders,  essentially  as a result  of  the  movements  of  people  and, to  a lesser  extent,  the 
movement  of  goods  and  the  consumption  of  water  and  foodstuffs.  Additional  factors 
include  climatic  change  (global  warming),  increased  resistance  to  antibiotics,  the 
immunological  status of  individuals,  and living  conditions  (socio-economic  problems). 
The  more that people  travel  about,  and the  further they  travel,  the greater the risks of 
these  diseases  spreading  in the form  of  epidemics  in unprotected  populations  and,  as a 
corollary, the greater the health risks to populations. From Asian flu  and cholera, to the 
HIV virus responsible for AIDS, examples abound both in history and in the present day. 
The agents responsible for communicable infectious diseases do not respect geographical 
frontiers.  And  despite  substantial  progress  in  the  field  of  public  health  protection,  the 
exposure of populations to the risk of contracting these diseases is increasing all the time. 

In  order  to  take  the  appropriate  measures  necessary  to  block  the  progress  of  these 
infectious diseases or prevent their appearance, national health authorities clearly need to 
have as precise  a picture as possible  of the epidemiological  situation.  This  can  only  be 
achieved  through the systematic  collection,  analysis  and interpretation  of  data on  these 
diseases,  followed  by their dissemination  to those  responsible  for  public  health.  Taken 
together these activities amount to epidemiological  surveillance,  an essentially  practical 
process the aim of which is to produce information  so that swift  action can be taken. In 
the  case  of  communicable  diseases  all  the  specialists  agree  that  the  cornerstone  is 
surveillance,  with the results being used  in order to control  and prevent these diseases. 
Epidemiological  surveillance  has  proved  its  worth  over  and  over  again,  the  outlay 
required being  amply repaid by the savings made in terms of  disease avoidance. 

In this general  context,  and since  infectious  diseases  can spread  easily  in the European 
Union  unless  suitable  measures  are  taken,  it  is  obviously  necessary  to  agree  on  the 
measures required for communicable disease surveillance. In this respect the Council and 
the  Ministers  for Health  of  the Member  States meeting  within  the  Council  adopted  on 
13 November  1992  a Resolution,  No.  92/C 326/1l,  inviting  the  Commission  to  report 
briefly  on the  existing  arrangements  established  between  the Member  States  or  by the 
World  Health  Organisation  (WHO)  for  the  surveillance  of  communicable  diseases, 
including  food-borne  diseases; to  identify  needs  and shortcomings;  and to  put forward 
proposals for  improvements.  And the European Parliament,  in its Resolution  on  public 
health policy after Maastricht2, 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 

1 
2 

OJ of  11.12.1992. 
OJ No C 329, 6.12.1993, p. 375 

international  agencies  on  such  matters.  Additionally,  in  its  Conclusions  94/C  15/043 of 
13 December  1993 the Council  requested  the  Commission  to put  forward  proposals  for 
the  setting  up  of  an  epidemiological  network  in  the  Community.  In  its  Communication 
COM(93)  559 of  24 November  1993 on  the framework  for  action  in the field of  public 
health  and its Communication  COM(94) 413 of  9 November  1994 on AIDS and  certain 
other  communicable  diseases,  the  Commission  proposed  specific  Community  measures 
in this  respect,  notably  the creation  and  development  of  surveillance networks. 

Without claiming to be exhaustive, this present Communication reviews the existing inter-
institutional  collaborative  arrangements  for  the  surveillance  of  communicable  diseases 
in the European Union. After  an explanation of the specific  nature of the epidemiological 
surveillance  of  communicable  diseases,  there  then  follows  an  attempt  to  analyse  the 
strengths and weaknesses of the present situation on the basis of certain objective  criteria 
the aim  of which  is to  meet the requirement  for  a high  level  of health  protection  within 
the European Community. Finally, proposals are put forward  for  short-and  medium-term 
surveillance actions for the prevention  and control  of communicable  diseases in- Europe, 
with due regard to the fundamental  principles which underpin the construction of Europe, 
namely  subsidiarity  and  Community  added  value. 

D. 

THE 
SURVEILLANCE  OF  COMMUNICABLE  DISEASES 

SPECIFIC  NATURE  OF  THE  EPIDEMIOLOGICAL 

Before  setting out into this vast area it is essential, in order to avoid potential  ambiguities 
and  misunderstandings,  to  define  the  context  and  the  concepts  used  and  to  outline  the 
scope of the activities concerned.  Such clarification  is necessary because we need to have 
a  clear  and  simple  idea  of  what  can  be  achieved  by  the  Community  in  this  area,  and 
because both nationally and at international level there is a profusion  of ongoing, but little 
known, initiatives and a confusing  interlacing of different  systems. And on top of all this, 
there  is a specific  quality  to the  surveillance  of  communicable  diseases which  needs to 
be  appreciated  from  the European  dimension. 

1 

DEFINITION  OF SURVEILLANCE 

For the surposes of the present communication  and decision, epidemiological  surveillance 
is defined  as the ongoing  systematic collection,  analysis and  interpretation  of health  data 
essential  to the planning, implementation and evaluation of public health practice, closely 
integrated with the dissemination  of these data to those who need to know for their work 
or  for  decision-making.  Surveillance  is  therefore  the  observation  of  certain  health 
phenomena  affecting  populations  or  groups  of  populations,  through  the  collection  of 
different  types  of  data,  so  that  swift  action  can  be  taken  if  necessary  to  correct  these 
phenomena.  In principle,  such  observation  is an ongoing  process, continuing  for  as long 
as the phenomena are liable to occur. It is therefore  an active and dynamic process which, 
from  the  public  health  point  of  view,  can  only  concern  situations  which  are  liable  to 
evolve  rapidly  if  no  steps  are taken  to  correct  them. 

OJ of  18.1.1994. 

In the language of the epidemiologist,  the term "surveillance" is in practice used to cover 
three types of case: communicable diseases; pollution-related health risks; and the safety 
of biological  products intended  for incorporation  to humans. In this latter case the term 
"vigilance" is used, for example haemovigilance  in the case of blood or blood products. 
Naturally,  surveillance  can  also  be  carried  out  for  non-communicable  diseases  such  as 
cancers,  cardiovascular  diseases  or mental  diseases.  But because these  diseases  develop 
slowly, and because of the nature of the information which needs to be collected on them, 
and because  there is  no  call  for  the type  of  urgent  action  called  for  to block  a rapidly 
spreading epidemic, the term "epidemiological observation" is used instead in these cases. 

2 

OBJECTIVES  OF  SURVEILLANCE 

In the field of communicable diseases the objectives of epidemiological  surveillance are, 
firstly,  to ascertain the incidence (number of new cases occurring over say a-month or a 
year) and the characteristics of a particular infectious  disease, and to study its pattern of 
spread  through  time,  space  and  social  categories,  so  as to  be  able  to  take  appropriate 
counter-measures. The second objective is to detect disease clusters or epidemics, or even 
abnormal  health incidents, through a system of warning indicators, so that measures can 
be taken to break the specific  transmission  chain.  And the third objective  is to describe 
and measure the risk factors for  contracting  a communicable  infection,  so as to be able 
to select and implement the most appropriate preventive measures and recommendations. 

These three interdependent objectives, taken together, constitute the basis for the activity 
referred to as the control  of communicable diseases. It is not some form  of checking up 
on  individuals  by  State  officials,  as  is  sometimes  erroneously  feared,  but  merely  a 
question  of  doing  everything  possible  to  stop  the  spread  of  a disease  and  re-establish 
normal  conditions,  i.e.  a high level  of health protection. 

In addition to dealing with de facto  situations,  surveillance  also serves as an instrument 
for evaluating preventive policies, particularly vaccination policy. Finally, surveillance can 
form  the basis  for  hypotheses  which  can then be  verified  by  means of  epidemiological 
surveys. 

3 

PRINCIPLES  AND  METHODS  OF  SURVEILLANCE 

Communicable  diseases  have  certain  basic  characteristics  which  were  described  in  an 
earlier  Commission  communication  (COM(94)  413  of  9 November  1994, paragraphs 6 
to  15),  to which  the  reader is  referred.  To  some  extent  these  characteristics  dictate the 
surveillance  methods which need to be employed,  since these diseases  are not all  alike, 
far from it. 

In practice, and according to epidemiology  specialists,  surveillance can be carried out on 
the basis  of  clinical  and/or biological  criteria  (the  data being furnished  for  example by 
general  practitioners  and test  laboratories)  or on the basis  of  surveys  (either  exhaustive 
or  sample,  depending  on  the  type  of  disease  under  investigation:  rare  and  serious 
infectious  diseases require exhaustive surveys, e.g.  compulsory notifications  or mortality 

registers,  whereas  common  and  less  serious  infectious  diseases  require  sample  surveys, 
based  on  networks  of  sentinel  doctors  and  sentinel  laboratories).  The  validity  of  the 
surveillance  depends  on  the  frequency  of  data  collection,  which  may  be  continuous  or 
periodic (but repeated at sufficiently  close intervals). Data may be collected passively (i.e. 
by awaiting the arrival  of the information)  or actively  (i.e. through regular or  permanent 
contact with  the information  source). 

Surveillance also depends on the geographical  level (i.e. local, national or international), 
and  the  data  transmission  medium  must  be  the  most  appropriate  for  the  requirements, 
particularly  as regards speed (e.g. written questionnaire, telephone, fax  or electronic data 
transmission).  Additionally,  a truly  rigorous  surveillance  operation  should  make use  of 
at least two  independent  and  complementary  surveillance  systems for  the same  disease: 
the  exhaustiveness  and  representativeness  of  the  data  collected  can  then  be  verified  by 
comparing  the data from  the  different  systems. 

Obviously, to enable an overall picture of the situation to be obtained all the surveillance 
data  must  be  collated  at  a certain  central  level,  which  means  the national  level  in  most 
countries  (leaving  aside  those  with  a  federal  structure).  The  same  applies  at  European 
level:  the  data  need  to be  centralised  so that they  can  be  processed  and  sent  out  to  the 
health  players. 

4 

THE  DIFFERENT  SURVEILLANCE  SYSTEMS 

A  number  of  different  surveillance  systems  on  communicable  diseases  are  in  use 
nationally  or  regionally. 

a) 
The classic system is the compulsory notification  system: general practitioners are 
obliged to notify  the health authorities whenever they diagnose a particular disease, at the 
same time furnishing  a certain number of additional details. The centralisation of the data 
allows  a close watch  to  be kept  on  the general  situation.  This  system  works  reasonably 
well  in  some countries, less so in  others (under-reporting)  and in most cases is based  on 
clinical  diagnosis  with  no  specific  case  definition.  Since  there  is  no  weeding  out  of 
duplicate notifications  or of unconfirmed  cases it cannot be relied  on to give an accurate 
picture  of the  situation.  The system  is most  effective  when  the incidence  of a disease is 
not too  high:  like  any  passive  surveillance  system  it  is  not  able to record  all  cases  of  a 
disease. 

b) 
For the above reasons, the compulsory  notification  system  is very often  replaced 
or augmented by networks of sentinel general practitioners. These are volunteers, forming 
a  representative  sample  of  1 to  4%  of  the total  number  of general  practitioners  in  their 
country  in  terms  of  age,  sex,  type  of  practice  and  place  of  practice.  These  doctors 
increasingly  tend to be linked up electronically  and their surveillance results are updated 
weekly  so  that  a  close  watch  can  be  kept  on  the  pattern  of  occurrence  of  the  diseases 
under  surveillance.  This  system  is  used  in  particular  for  common  diseases  with  a  high 
incidence,  since  trends  can  quickly  be  spotted  and  information  can  be  exchanged  and 
warnings  issued  rapidly,  almost  in  real  time. 

c) 
Networks of medical biology sentinel laboratories, recruited on the same principles 
as those used  for the  sentinel  doctors,  furnish  information  on microorganisms  (viruses, 
bacteria, germs, etc.) which they have identified in their day-to-day work, usually in tests 
to  confirm  clinical  diagnoses.  Several  such  networks  have  been  set  up  for  particular 
diseases,  and they play an important role in sounding the epidemiological  alarm. Not all 
Member  States have set up such networks, which  require considerable  organisation and 
constant  motivation,  i.e.  a significant  outlay in terms of resources. 

d) 
Specialist reference centres for communicable diseases provide additional  support 
through their  expertise  (identification  of  strains,  epidemiological  analysis); through  the 
warnings they are able to provide when poorly identified  clusters or isolated cases of rare, 
serious diseases occur; and through the technical  advice they are able to give the health 
authorities. 

e) 
The  range  of  surveillance  systems  is  completed  by periodic  or one-off  surveys, 
e.g.  for  studying  prevalence  (nosocomial  infections),  evaluating  preventive  measures 
(vaccination  cover) or determining the incidence of certain unmonitored diseases.  Other 
information  sources  (death  certificates,  sales  of  medicaments  and  vaccines,  health 
certificates,  hospital  morbidity  records,  etc.)  are  also  used  in  order  to  validate  the 
surveillance  systems indirectly. 

5 

QUALITY  OF  SURVEILLANCE  SYSTEMS 

The usefulness  of  a country's  surveillance  system  to public health officials  will  depend 
on  the  quality  of  the- system,  i.e.  its  capacity  to  provide  an  accurate  picture  of  the 
epidemiological  situation, as assessed by reference to a number of criteria.  This is  even 
more true at international  level:  a surveillance  system  at Community  level  would  serve 
little purpose if  data were not comparable. 

a) 
The sensitivity  of a surveillance system, i.e. the proportion of cases picked up by 
the  system  compared  with  the  total  number  of  cases  actually  occurring  in  a  given 
population,  is  a  key  assessment  criterion.  By  this  yardstick,  the  sensitivity  of  the 
compulsory notification  systems ranges from 5% (of cases reported by comparison to the 
true total) to almost  100%. In these circumstances,  where the notification  rate achieved 
is below  a threshold  of  somewhere  between  50  and  80% there must be  serious  doubts 
about  the  usefulness  of  the  system,  and  the  system  will  need  to  be  improved  or 
augmented with  other information  sources. 

b) 
The representativeness  of a surveillance  system  is, by definition,  a key  criterion 
in sample-based systems such as the sentinel  networks. This is particularly true when the 
sensitivity  of the accompanying  compulsory  notification  system is low,  since this could 
drastically  alter the true picture and lead to a false  assessment  of the situation. 

c) 
The notification  period, if too long,  can cause problems, especially  in  situations 
where effective  action is needed in order to control  an epidemic as quickly  as possible. 
Thus, while annual or quarterly notification of new cases may be appropriate for diseases 
which do not require immediate control measures, it is frankly inappropriate for diseases 

where  rapid  intervention  is  required.  This  factor  is  particularly  important  when  we  are 
dealing  with  a vast  geographical  area  such  as the European  Community. 

d) 
The  reliability  of  the  results  collected  depends  directly  on  whether  cases  are 
defined,  or whether  a person can be examined  by several  different  doctors in  succession, 
or  is  seen  several  times  by  the  doctor  because  of  relapses. 

e) 
The  confidentiality  of  the  data  collected  raises  ethical  and  legal  problems  in 
particular  when  the notification  questionnaire  enables the individual  to be identified  and 
includes  questions  on  the  sexual  behaviour  of  the  individual  or  questions  which  can 
identify  the  individual  as  being  HIV  positive.  There  are  strong  reasons,  therefore,  for 
making  the  questionnaires  anonymous. 

Other  factors  also play  a part  in the assessment  of  surveillance  systems: two  key 
f) 
factors  which  can  compromise  the  usefulness  and  smooth  functioning  of  a  surveillance 
system  are,  firstly,  the  absence  of  additional  data  frequently  essential  for 
the 
epidemiological  surveillance  of  a  given  disease,  and,  secondly,  the  lack  of  sufficient 
manpower  to  enable  surveillance  activities  to be  maintained  at  an  appropriate  level  and 
the  data  to be  analysed  exhaustively. 

m. 

INTERNATIONAL  COLLABORATION  PROJECTS  IN  THE  FIELD  OF 
DISEASE  SURVEILLANCE 

Historically, and quite naturally, many of the existing international communicable disease 
surveillance projects involving different  countries or their specialist institutions have been 
set up  on  the  initiative  of,  and  under  the  aegis  of,  the World  Health  Organisation.  The 
WHO'S span  in  Europe  extends  far  beyond  the  discontinuous  territory  of  the  countries 
which  make  up  the  European  Community.  Leaving  aside  the  diseases  covered  by  the 
International Health Regulations (MR), these cooperation projects are voluntary, and their 
effectiveness  depends  on  the  commitment  shown  by  the  partners  in  collecting  relevant 
data  and  transmitting  the  data  for  analysis  and  dissemination. 

These useful  -  in some cases vital  -  transnational  activities necessarily  have a cost,  both 
in terms  of  investment  and  operation.  The European  Community,  and  more  specifically 
the  European  Commission,  has  provided  substantial  financial  support,  usually  in 
cooperation  with  WHO. 

In  order  to  obtain  as  complete  a  picture  as  possible  of  the  networks  of  public  health 
players  specialising  in  the  surveillance  of  communicable  diseases,  the  Commission 
requested  a  small  group  of  experts,  at the  end  of  1993, to produce  an inventory  of  such 
networks,  using  a questionnaire  for  completion  by  health  experts in  the Member  States. 
For  the  purposes  of the  survey,  international  collaboration  was  taken  to  be  any  activity 
geared towards improving the fight against one or more communicable  diseases,  and  for 
which personnel  had been enlisted, whether for a limited  duration or otherwise, in at least 
three  European  countries.  The  list  of  collaboration  projects  identified,  together  with  a 
description  of  each  of them,  is described  in  the  Annex. 

1 

SYSTEMS  SET  UP  BY  WHO 

This is not  meant to be  an  exhaustive  analysis  of  all  of WHO's activities  in this  field.  It 
is  simply  a brief  outline  of  the  systems  operated  by  WHO  which  concern  the  European 
Community. 

The International  Health  Regulations  (IHR),  adopted  by  the  22nd  World  Health 
a) 
Assembly  in  1969 and  subsequently  amended  for  cholera by the 26th Assembly  in  1973, 
and  for  smallpox  by  the  34th  Assembly  in  1981,  are  designed  to  help  prevent  the 
international  spread  of  diseases.  The Regulations  oblige all  countries which  are party  to 
this  international  Convention  (this  includes  all  the  Member  States  of  the  European 
Community  but not the European  Community  itself)  to take measures to stop the  spread 
of  epidemic  outbreaks  due  to three  communicable  diseases: plague,  cholera  and  yellow 
fever.  Breaking  with  traditional  control  measures  such  as quarantine, which  are  usually 
inappropriate,  these  measures  consist  of  the  continuous  epidemiological  surveillance  of 
imported  cases, the early detection  of infections  and their notification  to WHO within  24 
hours, and the rapid and widest possible dissemination  of all relevant information.  These 
three  diseases  are  not  rife  in  Europe,  being  imported  diseases  which  have their  sources 
in  other parts of the world. WHO is the pivot for  the Member  States for  the  notification 
of cases. 

The system  remains something  of a formality,  however,  and  does not produce  extensive 
cooperation between the participating countries when incidents of these diseases occur on 
their  territories.  No  international  convention  can  be  expected  to  foresee  all  disease 
eventualities. In  some cases diseases and disorders  other than those covered by the IHR, 
for  example  certain  African  haemorrhagic  fevers,  can  be  tackled  by  the  national 
authorities  in  the  same  spirit.  But  in  the  light  of  experience  the  system's  practical 
feasibility  is such that it is difficult  to see how Community  cooperation could be of value 
in  this  area. 

The  other  international  exchange  systems under  the  WHO's aegis  are  concerned 

b) 
more  with  passive  surveillance.  Some of them  merit  closer  attention. 

tuberculosis) 

* The Expanded  Programme on Immunisation  (EPI), established by WHO in  1974, aims 
to  control  six  diseases  of  children  throughout  the  world  (diphtheria,  neonatal  tetanus, 
through  appropriate 
whooping  cough,  poliomyelitis,  measles  and 
immunisation cover. For the WHO's European zone, which covers 50 countries (including 
Russia and the  15 Community Member States), WHO objective No. 5 is slightly  different, 
namely  to  control  six  diseases  (the  same  six  as  above,  but  with  mumps  and  congenital 
rubella replacing tuberculosis and whooping cough) in the general  population by the year 
2000.  The  Member  States  are  in  addition  committed  to  the  following  four  objectives: 
eradication  of  poliomyelitis  by  the  year  2000; elimination  of  neonatal  tetanus by  1995; 
95%  reduction  in  measles  mortality  and  90% reduction  in  measles morbidity  by  1995; 
routine vaccination  against hepatitis B by  1995 if the prevalence of HBs antigen  carriage 
is more  than  8%,  and  vaccination  of  exposed  groups  against  hepatitis B by  1997  if  the 
prevalence  of  HBs  antigen  carriage  is less than  8%. 

These objectives  are merely  recommendations,  i.e. they  have no binding force,  and their 
attainment  therefore  depends  on  the  goodwill  of  the  national  public  health  authorities, 
whose  representatives  sit  in  a  management  group  and  an  advisory  committee.  These 
authorities  send  in their  surveillance  results,  in  principle  on  an  annual  basis: the  results 
are  of  course  a  vital  tool  for  verifying  the  implementation  of  any  immunisation 
programme.  But  the  fact  is  that  the  Member  States  are  far  from  being  united  in  their 
surveillance  methods  (case  definitions)  and  their  methods  of  determining  vaccination 
coverage,  thus hampering  proper  comparison  of  national  situations. 

*  Two  other  systems,  the  Collaborating  Centre  for  Health  and  Disease  Surveillance 
(Rome)  and  the  Surveillance  Centre  for  the  Control  of  Food-borne  Infections  and 
Intoxications  in Europe  (Berlin)  no  longer  appear to  fulfil  present  day  requirements. 

2 

SYSTEMS  SUPPORTED  BY  THE  EUROPEAN  COMMUNITY 

At the level of the European Community, Council Directive 92/117/EEC4 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 provides for a system for collecting  information 
on  specified  zoonoses  and  zoonotic  agents. Under  Article  5, Member  States are  obliged 
to  produce  a  report  by  31  March  each  year  on  the  trends  and  sources  of  the  zoonotic 
infections  recorded  during the previous year,  and the Commission  is obliged  to  evaluate 
the information  thus obtained  and report to the  Standing Veterinary  Committee before  1 
October  each year.  Leaving aside these  developments,  which  are not  directly  within  the 
remit of this Communication, initiatives in the field of communicable disease surveillance 
have been  developed  over the  last  decade  in  four  areas.  The first were  in  the  Research 
sector,  followed  by  technology  development  initiatives  in  the  Telecommunications  and 
Internal  Market  sectors, where substantial  resources have been allocated.  Since the entry 
into force of the Treaty establishing the European  Community, the Commission has been 
endeavouring  to support innovatory  initiatives or to accompany the Community's overall 
activities  in  the  context  of  the Framework  for  action  in  the  field  of  public  health.  The 
need  to  coordinate  these  crucial  public  health  activities  so  as  to  ensure  clarity  and 
coherence  is  now greater  than  ever. 

The Eurosentinel  system is the product of a concerted initiative launched in  1988, 
a) 
funded  for  three years by  the Biomed  programme  (medical  and  public  health  research). 
Its mandate was to promote the establishment of networks of sentinel general  practitioners 
and  to  coordinate  their  activities  in  certain  Member  States,  with  the  ultimate  target  of 
establishing  a  European 
surveillance  network  using  electronic  data 
communication  resources.  At  national  level  these  sentinel  GPs  form  networks  for  the 
rapid  dissemination,  in  standardised  form,  of  information  they  gather  during  the  course 
of their work, and they report their observations to a central national  structure. In the case 
cf  Eurosentinel  the  central  structures  are  linked  up  to  a  central  unit  within  the  Institut 
d'Hygiène  et  d'Epidémiologie  in  Brussels,  the  role  of  which  is  to  receive  and  store  all 

sentinel 

O J N o L 6 2,  15.03.1993, p. 38. 

information  relating  to  activities  in  the  field  of  sentinel  surveillance,  to  assist  and 
technically  advise the networks, to organise  scientific  meetings  and to publish a regular 
newsletter. 

Placed under the aegis  of  the Project  Management  Group, Eurosentinel  has the task  of 
observing the international  incidence of four health matters, based exclusively on clinical 
diagnosis: measles, mumps, prescription of HIV screening tests and influenza syndromes. 
Initially comprising the existing networks of five countries (Belgium, France, Netherlands, 
United Kingdom and  Switzerland), Eurosentinel  has since been joined by new networks 
set  up  in  four  other  countries  (Ireland,  Portugal,  Spain  and  Italy).  These  networks,  of 
variable  coverage  and quality,  are far from  uniform  in their organisation.  Their results, 
based exclusively on clinical  diagnosis (with no biological  confirmation),  are tinged with 
uncertainty,  the  more  so  as  there  is  no  common  definition  of  cases.  Despite  the 
discontinuation  of  Community  support  the  system  continues  to  function  thanks  to  the 
support of health authorities of these Member States. 

b) 

Telematic Networks between Administrations 

i)  CARE - Early warning  system 

Public  health  authorities,  whether  at  local,  regional  or  national  level,  have  the 
responsibility to ensure that the necessary information concerning cases of communicable 
diseases  liable  to  lead  to  epidemics  or  epidemic  outbreaks  is  available  and  is 
communicated  in good time to all  decision-making  bodies and/or bodies responsible  for 
implementing  appropriate measures. 

The  effectiveness  and efficiency  of  national  administrations  in carrying  out these tasks 
will be greatly enhanced by the setting up of an EU-wide modern, cost-effective  and user-
friendly  telematics  system,  linking  health administrations  in the Member  States,  so that 
they can exchange reliable information,  results and experience in real time, consult each 
other prior to introducing counter-measures as in the case of epidemics, coordinate their 
responses,  particularly  where  these  might  have  economic  and social  consequences,  and 
improve  the  formulation  of  policies  and the  planning, financing and  administration  of 
health services. 

The Council decision of 6 November  1995 on support for IDA (telematic interchange of 
data between  administrations  in  the  Community)5  foresees  two  projects  in  the  field  of 
health, namely  CARE (two  sub-projects  : early warning system and pharmacovigilance) 
and REITOX (European  network  of  information  on drug addiction). 

The two CARE sub-projects under IDA are spin-offs  of  earlier efforts  on the European 
Nervous  System  (ENS-CARE)  supported by the Commission under the 3rd Framework 
Research and Technological  Development Programme over the period  1991 to  1993; its 
current situation permits the gradual passage from ihe pilot to the exploitation phase, with 

OJNoL269,  11.11.1995, p.23. 

10 

the  general  architecture  and  infrastructure  for  communicable  diseases,  health  data and 
indicators and pharmacovigilance. 

Under  current  IDA  plans,  CARE-Early  warning  system  (CARE-EWS)  work  will 
concentrate over the next two years on development of the pilot system between national 
administrations,  while  strictly  adhering  to  the  general  system  architecture  foreseen  for 
IDA.  Apart from  the infrastructure  and architecture aspects of a system  such as CARE-
EWS  linking  national  administrations,  the  content  of  information  to be  exchanged  will 
have to be determined. This will have to be specified by the Commission in collaboration 
with  the  administrations.  To  this  end,  the  Commission  is  presenting  a  proposal  for  a 
decision  by  the  European  Parliament  and  the  Council  concerning  the  setting  up  of  a 
European  Community  system  for  the  epidemiological  surveillance  and  control  of 
communicable  diseases. 

The Commission  has already  presented  a communication  and a proposal  for  a decision 
on a programme concerning health data and indicators.6 The latter programme, as distinct 
from the effort directed towards communicable disease surveillance, aims at providing the 
necessary information on health status and health determinants and would, as appropriate, 
draw  from  information  generated  by  communicable  disease  surveillance.  It  does  not, 
however,  have  the  objective  of  securing  the  rapid  sharing  of  detailed,  validated  and in 
most  cases  confidential  information,  and the  coordination  of  responses,  when  cases  of 
communicable  diseases liable to lead to epidemic  outbreaks occur. 

ii) The G7 Global  Healthcare Applications Project 

in 

The G7 Global Healthcare Applications Project contains a sub-project, "Towards a Global 
Public Health Network",  a key  element  of which  is the design of  an international  data 
exchange 
through  new 
the  areas  of  communicable  disease  surveillance 
telecommunication  technologies.  These  activities  take  into  account  the  experience 
acquired from  the "Wonder project" run by the USA's  "Centers for Disease Control", as 
well  as the recommendations made to the President of the United  States by the National 
Science  and  Technology  Council  in  the  report  "Infectious  disease  -  a  Global  Health 
Threat". This detailed  report presents an overview  of  the problems and of the  obstacles 
to combating infectious  diseases  and proposes a step-by-step  model  for the adoption  of 
appropriate measures,  including  a Worldwide  Communication Network. 

c) 

European Centre for  the Epidemiological Monitoring of AIDS 

This  Centre,  financed  by  the  European  Community  in  the  context  of  the  BIOMED 
research programmes  and the Europe  against  AIDS  programme,  was  set up in  1987  in 
Paris.  It is responsible  for the  surveillance  of  AIDS  and HIV infection  in the European 
Community and the other territories covered by WHO Europe, with whom it collaborates. 
The  Centre  receives  non-aggregated  data  on  diskette  every  three  months  from  all  the 
countries  in the WHO's European zone,  which extract the data from their national data 
bases. They include various indicators concerning the disease and its diagnosis, together 

COM 95 (449) of  16.10.1995. 

11 

with  comments  on the trends over the past three months.  The data are depersonalised  so 
that  it is not  possible  to  identify  the  individuals  concerned,  whatever  their  geographical 
location.  The  Centre  also  produces  tables  of  figures  and  collects  data  concerning 
anonymous  screening  programmes. 

d) 

Ongoing surveillance  activities 

Currently, because  Member  States' surveillance systems differ  so widely, the data issued 
by  Member  States  on  communicable  diseases  are  not  intercomparable.  In  addition,  not 
enough epidemic outbreaks are detected and correctly investigated. In such circumstances 
it is only  rarely  that  appropriate  recommendations  can be formulated,  because there is a 
lack  of  epidemiologists  trained  in  this  type  of  intervention.  Field  epidemiology,  which 
involves the application  of  epidemiological  methods to  surveillance,  to  data  production, 
to public health action and to the monitoring of infectious  diseases, is the approach which 
is needed  in  order  to  contain  and,  if  possible,  clear up  epidemics.  In  this  context,  there 
is  clearly  a  need  for  collaboration  as  regards  training  students  in  the  epidemiology  of 
communicable  diseases. 

The development  of a cadre of public health  personnel  with  a common  knowledge base, 
common  skills  and  a  common  approach  to  epidemiology  could  greatly  stimulate 
harmonised  activities  in  the  field  of  public  health,  and  especially  in  the  field  of 
communicable  disease  prevention.  For  this reason  the  Commission  has since  1994 been 
providing  financial  support,  under  the  programme  on  AIDS  and  other  communicable 
diseases, for a field epidemiology training programme coordinated by the IHE in Brussels. 
The project  involves sending ten or so epidemiologists from  the Community  to locations 
in  other Member  States  for  a  two-year  period  in  order  to  acquire  experience  and  skills 
in  the  field  of  epidemiological  intervention  (control  of  communicable  diseases)  -
something  which  is  lacking  in  the  Community  at  present.  Thanks  to  this  innovative 
project  a  new  network  of  specialists  in  the  surveillance  of  communicable  diseases  is 
gradually  emerging,  and this network  should be up and  running properly within  the next 
two  or three years. 

In a similar context, the AIDS Centre in Paris is currently coordinating a feasibility  study 
for  the  creation  of  a European  bulletin  of  communicable  diseases, which  would  publish 
surveillance data on a monthly basis. The producers of the national bulletins have already 
set  up  a  coordination  structure,  in  liaison  with  the  national  institutions  responsible  for 
surveillance in the Member  States, with  a view to setting up such a bulletin  permanently 
at  European  level.  This  bulletin  would  regularly  publish  data  from  existing  and  future 
surveillance  networks  and  from  epidemiological  surveys;  would  compare  the  different 
national  approaches  to  public  health;  and  would  collect  information  of  international 
interest  from  the Member  States'  national  bulletins. 

3 

OTHER  NETWORKS 

As  shown  in  the  Annex,  other  international  networks  of  a  similar  nature  have  been  set 
up by surveillance professionals  in the public sector,  sometimes in collaboration  with the 
private  pharmaceutical  industry,  as  is  the  case  for  influenza.  Other  networks  concern 
meningitis,  listeriosis  and  paediatric  diseases. 

12 

IV.  REVIEW  OF  THE  EXISTING  SITUATION  AND  PROPOSALS  FOR 

FUTURE  COMMUNITY  ACTION 

1 

ASSESSMENT  OF  THE  EXISTING  SITUATION 

Since  detailed  information  on  all  the factors  necessary  for  a rigorous assessment  is not 
available,  it  is  not  easy  to  provide  an  in-depth  analysis  of  the  existing  situation 
concerning  disease  surveillance  at Community  level,  still  less  so to  deliver  a judgment 
on it. However, it is useful to review the situation on the basis of a checklist, whether this 
be  of  diseases  grouped  together  thematically,  or  of  modes  of  transmission,  or  of  the 
criteria which determine the quality  of a surveillance  system, as mentioned  at point II.5. 

The criteria for assessing the pertinence of a surveillance operation and the suitability  of 
the existing  system  or systems can be organised  as follows: 

a) 

By  type of disease: 

diseases preventable by  vaccination 
sexually  transmitted  diseases,  hepatitis B, AJDS/HTV 
hepatitis (C and  unclassified) 
food-borne  diseases 
zoonoses  (for the record) 
imported  diseases 
respiratory  diseases  (tuberculosis) 
nosocomial  infections 

b) 

By  modes of transmission: 

1. water-borne: 

-  cholera, hepatitis A,  legionellosis  (water quality) 

2.  zoonotic: 

-  brucellosis,  trichinosis,  Campylobacter,  echinococcosis, 
rabies,  Yersinia,  etc. 

3.  food-borne: 

4.  inter-human: 

-  salmonellosis (S. enteridisi, typhimurium, virchow, napoli) 
-  listeriosis 
-  E.  coli 
-  shigella 
- etc. 

% 

-AIDS 
-  STDs (syphilis,  chlamydiases,  genital  herpes) 
-  tuberculosis 
-  hepatitis B  and C 
-  influenza  and influenza  syndromes 
-  meningitis:  Haemophilus  influenzae B;  meningococci, 
A,B,C;  pneumococcus 
-  etc. 

13 

5.  blood: 

-  HIV/AIDS 
-  hepatitis B and C 
- etc. 

6.  environmental: 

-  legionellosis 
-  aspergillosis  (nosocomial  infections) 
-  etc. 

7.  particular: 

- Creutzfelt-Jakob  disease 

-  etc. 

c) 

By  the criteria determining  the quality  of  a surveillance  system: 

.  sensitivity 
.  representativeness 
. notification  frequency 
.  reliability 
.  confidentiality 
.  follow-up  (resources  allocated) 

In the light of this general  review  it could  be possible  to compare the existing  situation 
with  what  could  theoretically  be  done  in  the  way  of  disease  surveillance.  The 
Commission,  working  in  close  cooperation  with  the  Member  States'  authorities 
responsible  for  communicable  disease  surveillance,  intends  to  put  forward  appropriate 
proposals for the adoption of measures necessary to improve this type of epidemiological 
surveillance in the Community. It is already clear that tuberculosis and hepatitis C, which 
the Commission mentioned in its Communication (COM(94) 413),  should be considered 
under this approach as meriting  particular attention. 

As  a general  rule,  it  appears that  collaborations  are becoming  more  sophisticated,  with 
increasingly  standardised methodology  and better technical  support. Projects which were 
developed  within  single  institutions,  without  an effective  partnership  between partners, 
have  tended  to  be  less  successful.  Of  course,  the  opposite  is  true  (when  the  various 
opposing  elements  are^all  brought  together).  Historically,  projects  had  not  always  had 
clear  objectives underpinned  by  an effective  setting  of  criteria  and scientific  standards. 
Ongoing,  independent  scientific  input is  essential  for a project to be successful,  and has 
not always been present. 

The strength  of  any collaboration  depends on the quality  of the data at the point where 
it  originates  and  therefore  relies  on  the  quality  of  national  systems,  which  are 
heterogenous.  Procedures  such  as  coordinating  and  improving  existing  systems  (rather 
than  developing  new  systems)  and  developing  uniform  agreed  case  definitions,  are 
important  to  the  development  of  effective  collaborations.  Clearly,  within  any  one 
collaboration  one partner might take the lead,  or have a greater role than others. 

14 

2 

CONCLUSIONS 

After  examination  of  the  various  international  cooperation  schemes  for  communicable 
disease surveillance, and after  consultation  by the Commission  of national  experts and of 
those  responsible  for  disease  surveillance  in  the  Member  States,  a  certain  number  of 
conclusions,  on  which  there  is  agreement,  can  be  drawn. 

a  -  There  is  a  growing  need  for  European  collaboration  on  the  prevention  of 
communicable  diseases  and  such  collaboration  should  be  accorded  the  highest  priority. 
Reasons for this include: the increasing  mobility  of populations  due to tourism,  business 
and  migrations  in  general;  the  increasing  freedom  of  movement  for  goods;  the  re-
emergence  in  Europe  of  once  familiar  infectious  diseases  such  as  tuberculosis  and 
poliomyelitis;  the  emergence  of  new  infections,  such  as  those  due  to various  strains  of 
E.  coli  0157  secreting  cytotoxins;  the  breakdown  of  communicable  disease  prevention 
measures  in various  parts  of  eastern  Europe,  etc. 

b  -  In  order  to  promote  effective  preventive  action  against  communicable  diseases, 
European  Community  collaboration  in  the  fields  of  public  health  surveillance  and 
microbiology is essential. At present, there is not even a list of structures and  laboratories 
to  enable  analyses  and  identifications  to be  carried  out  at  Community  level. 

c  -  The fact  that  various joint  surveillance  projects  are being  considered,  or  are  starting 
to  see  the  light  of  day,  shows  that  the  need  for  European  collaboration  is  widely 
recognised. However,  since there are clearly gaps, overlaps and wide variations (in terms 
of  quality,  quantity,  uniformity  over  time,  and  reliability)  in  the  data  yielded  by  the 
present  systems, these  activities  need  to be  coordinated  within  the  Community. 

d  - There are currently  wide  differences  in the Member  States' vaccination  programmes 
and  schedules.  The  improvement  of  surveillance  and  of  research  to  facilitate  the 
harmonisation  of vaccines would bring much-needed  rationalisation to this area of public 
health. 

e  -  In  order  to improve  surveillance  at  European  level  there  is a need  to  identify  more 
precisely  those  areas  in  which  there  is duplication  of  activity  and  to  establish  priorities 
for  the  implementation  of  collective  projects.  Accordingly,  there  is  a  need  to  promote 
collaboration between experts from  the national institutions responsible for  communicable 
disease surveillance. Activities in this domain ought to be coordinated  with the  activities 
already  being  carried  out by  the World  Health  Organisation,  particularly  WHO/Euro. 

f  -  The  establishment  of  contact  networks,  which  are  necessary  for  the  development  of 
these activities, would be facilitated  by the organisation  of regular meetings between  the 
experts responsible  for the national  surveillance  programmes.  These meetings  should  be 
devoted  to  the  public  health  problems  inherent  in  communicable  disease  surveillance, 
microbiology  and  identification  of the  problems  and  priorities  at European  level. 

g  - All  the Member  States without  exception  should  participate  in  such  a network,  with 
full  account  being  taken  of  the  fact  that  the  degree  of  surveillance  and  prevention  of 
communicable  diseases  varies  substantially  from  country  to  country.  Since  infectious 

15 

diseases  know  no  frontiers,  consideration  should  be  given  to  extending  the  network  to 
include  neighbouring  non-Member  States  or  countries  with  special  relations  with  the 
Community  (such as the USA),  on a basis yet to be  defined. 

h - Several  of the existing European surveillance networks for certain specific  infections 
could  serve as models  for  other infections,  since they  employ  standard case  definitions 
and  methodologies  agreed  on jointly  by  the  participants  and  transmit  their  regularly 
updated data to a coordinating centre at regular intervals. The following  are examples of 
high interest: 

• 
The  system  for  notifying  AIDS  and  HIV  cases  to  the  European  AIDS 
Epidemiological  Surveillance  Centre in Paris, resulting in trend data which constitute a 
useful  basis for preventive action.  This example, could be followed  in  order to  develop 
similar information  systems for hepatitis, tuberculosis and sexually transmitted diseases. 

• 
The  EWGLI  information  system  for  laboratory-diagnosed  legionellosis  cases, 
coordinated  by  the Public Health  Laboratory  Service's  (PHLS)  Communicable  Disease 
Surveillance  Centre  in  London,  which  permits  the  swift  detection  of  epidemics  with a 
common  source.  It  provides  trend  data,  enabling  preventive  measures  to  be  taken  as 
quickly  as  possible.  A  similar  system,  SALMNET, 
is  proposed  for  salmonellosis  and 
could also be applied to listeriosis and infections  due to strains of E. coli 0157 secreting 
verotoxin. 

i  -  To  achieve  greater  harmonisation  in  areas  such  as  quality  control  and  the  most 
sophisticated techniques (e.g. phage typing and genotype establishment,  identification  of 
viruses responsible for African haemorrhagic fevers) used for identifying micro-organisms 
with ever greater precision. 

3 

FUTURE  ACTIONS 

On  the  basis  of  these  conclusions,  there  will  be  two  major  strands  to  the 
a) 
Community's future  actions concerning  communicable  disease surveillance  and control: 

-  Firstly,  the  establishment  of  a  system  for  the  surveillance  and  control  of 
communicable  diseases  at  Community  level,  requiring  the  exchange,  at  appropriate 
moments, of accurate and reliable information concerning diseases for which specific case 
definitions,  identifications  and  verifications  are  required.  It  is  proposed  to  set  up  this 
system  on the basis  of  a European Parliament  and  Council  decision,  and to  exploit the 
infrastructure  set up by the IDA programme. 

-  Secondly, various measures such as the development  and coordination  of intra-
Community  collaborations;  assistance  for  pilot  projects  to  facilitate  the  setting  up and 
smooth running of the key elements of  surveillance  systems at national  level; exchanges 
of  experience,  notably  through  meetings  of  experts;  cooperation  with  non-member 
countries  and  international  organisations  competent  in  this  field;  the  training  of  field 
epidemiologists;  the  production  and  dissemination  of  information  tools,  such  as 
epidemiological  surveillance  bulletins;  support  for  European  microbiologists  for  the 

16 

creation  of  an  inventory  of  collaborative  ventures  in  Europe  and of  national  resources 
currently  available  in  the  relevant  fields  of  microbiology.  These  measures  will  be 
undertaken  in the  context  of  the  future  programme  concerning  AIDS  and certain other 
communicable  diseases,  for  which  the  Council  adopted  a common  position  on  2  June 
1995 (OJ 95/C 216/02)7 and which was the subject of a conciliation procedure, pursuant 
to Article  189b of the Treaty,  on  19 December  1995. 

b) 
As  regards  the  setting  up  of  a  system  for  the  surveillance  and  control  of 
communicable  diseases  at Community  level,  the  Commission,  in  its  communication  of 
24 November  1993 on the framework for action in the field of public health, outlined the 
principles  and strategies to be followed  in implementing  Community  activities  directed 
towards the attainment of the health protection objectives laid down by Articles 3(o) and 
129 of the Treaty establishing the European Community.  The role of the Community  is 
to  underpin  the  efforts  of  the Member  States in  the public  health field, to  assist  in the 
formulation  and  implementation  of  objectives  and  strategies,  and  to  contribute  to  the 
continuity  of  health  protection  provision  across  the  Community,  setting  as  a target the 
best results already  obtained  in a given  area anywhere in the Community. 

The Commission's proposal for the creation of such a network advocates that the Member 
States should participate fully  in its organisation and implementation. The network's task 
will  be to ensure coordination in the collection, processing and exchange of information 
necessary for the prevention and control  of communicable diseases. Focusing on disease 
prevention,  and.  following  the  principles  of  subsidiarity  and  proportionality,  this 
Community action is designed to help the authorities responsible for public health to take, 
at State level, measures to block the progression of these infectious diseases or to prevent 
their appearance. 

c) 
Consequently,  this proposal  seeks to establish  a system  of close cooperation and 
effective  coordination  between  Member  States in the field of  surveillance,  both routine 
and  emergency,  with  a view  to  improving  the  prevention  and  control  in  Europe  of  a 
certain number of  serious  communicable  diseases  which  necessitate the introduction  of 
measures  for  the  protection  of  populations.  The  proposal  is  modelled  on  Community 
instruments already adopted in similar areas for the accomplishment of similar objectives. 
The  data  in  question  will  be  collected  in  aggregated  form  and will  in  no  case  enable 
individuals  to  be  identified.  Thus,  they  will  not  conflict  with  Community  instruments 
concerning the protection of personal  data, such as Council  Directive C 95/46/EC of 24 
October  1995 on the protection  of  individuals with regard to the processing  of personal 
data  and  the  free  movement  of  such  data8.  They  will  however  comply  with  the 
Community  provisions  concerning  systems  of 
information  exchange  between 
administrations. 

d) 
The setting up of this network for the surveillance of communicable diseases takes 
account of,  and is based on, the situation already existing in this field at European level. 
It also aims to avoid unnecessary duplication of work by ensuring that all Member States 

7 

8 

OJNoC216,  21.8.1995, p. 2. 
OJNo  L 281, 23.11.1995, p.31 

17 

have the same conception  of  surveillance,  as a result of  defining  with them  the type  of 
information  required and the arrangements appropriate for each group of  communicable 
diseases. Finally, other parties will be associated with the network: these will  include  the 
competent international organisations (notably WHO), the surveillance networks to which 
Member  States  already  belong,  and non-member  countries.  Cooperation  with  the  USA 
towards the setting up of a global  early warning and response system  has already begun 
within the framework  of the EU-USA action plan, and also within the framework of the 
Gl  Global Healthcare Applications Project, in which Canada and Japan are also involved. 
An  important  aspect  of  this  latter project  is  the  application  of  new technologies  to the 
international  exchange  of  data in the field of  communicable  disease  surveillance. 

e) 
The recently created Task Force on Vaccines and Viral Diseases should also help 
to coordinate efforts to establish a European Communicable Disease Surveillance System 
building  on existing  pilot  activities  and legislative  initiatives.  Its main thrust  should  be 
to ensure adequate information  flows  between  the vaccine  research  community  and the 
surveillance networks and to focus on endemic identifiable infections as well as voluntary 
data constituencies on specific outbreaks. Furthermore, the Task Force would catalyze the 
integration  of  common  European  expertise  into  the  surveillance  system  at  a  level  of 
specific  laboratory  facilities. 

f) 

The implementation of the decision will yield added value in a number of ways: 

It will  ensure the  setting  up  of  a system  of  continuous,  well-structured,  reliable 
and effective communication at Community level between national communicable disease 
surveillance  authorities,  something which  is lacking  at present; 

It will  facilitate  the  rapid,  reliable  and  commonly  agreed identification  of  cases 
of  communicable  diseases  occurring  inside  the  Community,  or  occurring  outside  and 
therefore being imported  or likely  to be imported; 

It will  give  the  competent  authorities  the  opportunity  and the  means to  consult 
together on the preventive measures to be taken, and it will  help them in the coordinated 
introduction  of  such "measures and the evaluation  of their  effectiveness; 

It will  give  the  authorities  the  support  they  need  for  analysing  and  interpreting 
data  and  for  deploying  the  necessary  measures  to  stop  communicable  diseases  from 
spreading. 

18 

ANNEX 

I - EXISTING  COLLABORATIONS 

A -  Surveillance 

/  -  WHO Collaborating Centre for  Health and Disease  Surveillance 

Diseases  surveyed 

Notifiable  diseases or diseases  otherwise  subject to  systematic/obligatory  reporting  at a 
national  level. 

Data sources 

Periodical  bulletins  of  communicable  disease  surveillance  prepared  by  participating 
countries,  according  to  the  variable  criteria  which  may  apply,  and  supplemented  by 
retrospective  cumulative  data  from  WHO  Regional  Office  and the  statistical  office  of 
WHO Headquarters. 

International  reporting 

Twenty  five  countries  submitted  data by  post to the  centre at the Instituto  Superiore di 
Sanita  in  Rome.  Data  is  available  for  Albania,  Austria,  Belgium,  Bulgaria, 
Czechoslovakia, Denmark, Germany, Finland, France, Greece, Hungary, Iceland, Ireland, 
Israel,  Italy,  Luxembourg,  Malta,  Monaco,  Morocco,  Netherlands,  Norway,  Poland, 
Portugal, Romania, San Marino,  Spain,  Sweden,  Switzerland, Turkey, United Kingdom, 
Russia and Yugoslavia. 

International  feedback 

Eight  bulletins  summarising  disease  occurrence  by  YEAR  by  COUNTRY  have  been 
produced  since the scheme's inception. 

Inputs 

100% provided by participants.  Start up moneys of  $3,000 US were provided by WHO 
Regional  Office. 

Dates of  i)  commencement  and ii)  completion 

i)  1983 

ii)  ongoing. 

19 

Value 

Four  enquiries  have been  received  in the  last  3 years.  The  quality  of  the  data  reported 
nationally  does  not  merit  the  effort  of  international  collation  in  the  views  of  the 
Collaborating  Centre. 

20 

2 - Expanded Programme on Immunisation 

Diseases  surveyed 

Incidence  of  Diphtheria,  Tetanus,  Pertussis,  Poliomyelitis,  Measles,  Mumps,  Rubella. 
Immunisation  coverage. 

Data sources 

Generally based on passive reporting via notification  schemes in countries11.  Assessment 
of vaccine coverage uses different approaches in different countries (see below, "Research 
in Methodologies  of Immunisation  Programmes Management in Europe"). 

International  reporting 

Tabulated data is sent periodically  to WHO European Regional  Office  in Copenhagen. 

International  feedback 

A  publication  summarising  immunisation  coverage  and incidence  of  six  target  diseases 
(Diphtheria, Measles,  Pertussis,  Poliomyelitis,  Tetanus and Tuberculosis)  is produced  6 
monthly. 

Inputs 

Submission  of tabulated data to WHO by participating countries. 

Dates of 0  commencement  and ii)  completion 

i) Longstanding  ii)  Ongoing 

Value 

International  comparisons have given  an impetus to beneficial  modifications  of national 
schedules.  Identification  of  risk  areas  (eg  Diphtheria  in  the  countries  of  the  former 
USSR). 

21 

3  - Eurosentinel 

Diseases  surveyed 

Range  of  communicable  diseases. 

Data  sources 

Clinical diagnoses from various networks of sentinel General Medical Practitioners (GPs). 
Case  definitions  used  vary  between  networks  but  are  invariably  physician  based. 

International  reporting 

Weekly  totals  of  disease  occurrence  are  sent  by  fax  to  the  Institute  of  Hygiene  and 
Epidemiology,  Brussels.  Data  is  available  from  Belgium,  France,  The  Netherlands, 
Portugal,  Spain,  Switzerland  and  United  Kingdom. 

International  feedback 

A  Bulletin  of  the  Institute  of  Hygiene  and  Epidemiology  is  prepared  periodically,  as 
resources  permit,  on  behalf  of  the  collaborating  networks.  This  tabulates  disease 
occurrences  by  country  by  week  and  is posted  to  collaborators. 

Inputs 

Submission  of tabulated  data  to Institute  of Hygiene  and  Epidemiology  by  participating 
networks.  The Institute of Hygiene and Epidemiology  estimate their input to co-ordinate 
the scheme to be  1  hour of medical  staff  time,  1 hour of scientific  staff time and 4 hours 
of  clerical  staff  time  per week  with  all  inputs  since  1991  provided  nationally. 

Dates  of  i)  commencement  and  ii)  completion 

i)  1988  as  EC  concerted  action  programme,  ii)  1991  but  the  Institute  of  Hygiene  and 
Epidemiology  has  continued  the  scheme  on  an  informal  and  unfunded  basis  since  then 
as a service  to the  collaborating  networks. 

Value 

Acts as a clearing  house for  information  about  activities  in  the field of  sentinel  practice 
schemes and a source of scientific  support for them.  During the  1989 influenza  epidemic 
the data was used to review spread  through  Europe  and to  encourage vaccination  and to 
brief  the  media  in  certain  countries. 

Potentially  the  scheme  could  support  the  development  of  sentinel  networks  in  those 
countries  which  do  not  possess  them  and  also  organise  international  studies  based 
in 
those  participating  networks  which  are  already  established. 

22 

4 - WHO Surveillance Programme for  Control of Foodborne Infections and Intoxications 
in Europe. 

Diseases  surveyed 

Foodborne  disease,  defined  as  "a  disease  of  an  infectious  or  toxic  nature  caused  by  or 
thought  to  be  caused  by  the  consumption  of  food  or  water". 

Data  sources 

Reporting from  the responsible surveillance institution.  Criteria for including data  differ. 
Some  countries  consider  a  disease  as  foodborne  only  when  the  causative  agent  was 
identified  in  the  patient  as  well  as  the  food;  other  countries  find  it  satisfactory  when 
there is epidemiological  evidence  and yet  others  include  all  diarrhoeal  diseases. 

International  reporting 

Reporting procedures vary between  countries.  Data is sent to the Institute of Veterinary 
Medicine - Robert von Ostertag Institute (FAO/WHO Collaborating Centre for  Research 
and  Training  in  Food  Hygiene  and  Zoonoses,  Berlin.  Data  is,  or  until  recently  was, 
available  from  Albania,  Austria,  Belgium,  Bulgaria,  Cyprus,  Czechoslovakia,  Denmark, 
Finland, France, Germany, Greece, Hungary, Iceland,  Ireland, Israel, Italy, Luxembourg, 
Malta,  Monaco,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Spain,  Sweden, 
Switzerland,  Turkey,  United  Kingdom,  USSR,  Yugoslavia. 

International  feedback 

Five reports have been published  since the schemes  inception.  The most recent  covered 
the period  1985-1989 and was published  in  1992. Data is presented in a series of country 
reports  with  little  attempt  at  inter-country  comparisons.  More  immediate  feedback  is 
provided  by  newsletters  which  are published  approximately  4 times  per  year. 

Inputs 

Submission  of tabulated  data to Robert von  Ostertag Institute by  participating  networks. 

Dates  of  i)  commencement  and  ii> completion 

i)  1980 ii) Ongoing.  The programmed  is intended to become of the 4 components of the 
Food  Safety  Pilot  (ie  application),  one  of  the  4  subsidiary  projects  of  the  European 
Nervous System (ENS) /CARE Telematics programme, funded  by European  Commission 
to  develop  European  electronic  communications  networks. 

Value 

Stimulus  to  national  authorities  in  their  efforts  to  strengthen  the  prevention  and  control 
of  foodborne  diseases. 

23 

5  -  British  Paediatric  Surveillance  Unit  (BPSU)  and  Union  of  European  Paediatric 
Societies  and  Associations 

Diseases  surveyed 

Rare infectious diseases and infection related conditions in patients under 16 years of age. 
(Up to  12 disorders at any one time).  Rare non infectious  conditions are also surveyed. 
Infectious  diseases which are, or have been,  surveyed  are HIV/AIDS, Neonatal  Herpes, 
Sub-acute  Sclerosing  Pan  Encephalitis,  Haemolytic  Uraemic  Syndrome,  Congenital 
Toxoplasmosis,  Rheumatic  Fever,  Congenital  Rubella,  MMR  associated  Meningo 
encephalitis,  Acute  Flaccid  Paralysis,  Haemophilus  influenzae  type  B  (HiB)  vaccine 
failures. 

Data  sources 

Defined  diagnoses of conditions under surveillance  reported monthly by a postal  report 
card ("orange  card") by  1,160  participating hospital  paediatricians. 

International  reporting 

This  is  made  to  BPSU  at  the  British  Paediatric  Association  Offices  in  London.  An 
important feature is the requirement to make a nil return if no cases of the diseases under 
surveillance  have  been  seen  by  the  paediatrician.  Data  is  available  form  the  United 
Kingdom  and Ireland.  Similar but separate schemes have now commenced in Germany 
and the Netherlands. 

International  feedback 

Six  annual  reports  have been  published  since  the  schemes  inception.  The  most  recent 
was published  in  1993.  Regular  scientific  publications  are made. 

Inputs 

Submission  of  report cards to BPSU by participating  clinicians. 

Dates  of i)  commencement  and ii)  completion 

i)  1986 ii) Ongoing.  The Union of European Paediatric Societies and associations formed 
a working group in  1991 to develop a network of European paediatric surveillance units. 
The  group  includes  9  countries  and  has  applied  for  EC  funding  as  a concerted  action 
programme for  1993. 

Value 

The scheme has enhanced ascertainment  and the provision  of  data of good quality for a 
variety of rare conditions.  It has been imitated in other countries and is being considered 
by  other specialties. 

24 

6  - EURO. NES Scheme for  Surveillance  of Nosocomial  Infection 

Diseases  surveyed 

Nosocomial  infections and Pneumonia in Intensive Therapy Units (ITUs) to identify risk 
factors,  evaluate control  measures and assess the feasibility  of a surveillance system. 

Data sources 

For a one month period participating  physicians in ITUs form  a convenience  sample of 
volunteering  hospitals  reported  to  national  centres  the  isolation  from  their  patients  of 
microorganisms which were hospital acquired.  Data was available on the age and sex of 
the  patient  and  the  severity  of  clinical  illness,  the  procedure  undergone,  intercurrent 
illness/therapy,  smoking habits and the existence  of  infection  at admission. 

International  reporting 

Data was posted to the University  of Lyon,  France.  Data was obtained from  Belgium, 
Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, 
Switzerland,  United Kingdom. 

International  feedback 

Analysis of risk factors has been received back from coordinators.  Scientific publication 
is awaited. 

Inputs 

Study  costs  within  countries  met  by  participants.  EC  provided  software,  organised 
meetings and funded  collaborative aspects. 

Dates of H commencement  and ii)  completion 

i)  1990 ii)  1992: data analysis continuing.  Fieldwork  was of  1 month's duration. 

Value 

Potential  for  setting  standards for  in-patient care. 

25 

7 -  WHO Influenza Surveillance 

Diseases  surveyed 

Laboratory  isolation  of influenza  virus or serological  evidence  of  influenza  infection. 

Data sources 

Specimens  submitted by clinicians to diagnostic  laboratories within countries. 

International  reporting 

Data is  sent  by  post  or fax  to  the WHO  Influenza  Collaborating  Centres  on  Influenza 
Reference  and  Research  in  London  and  Atlanta,  USA.  Data  is  obtained  from  46 
laboratories in 25 developed countries and 64 laboratories in 52 other countries, covering 
nearly  all  parts of the world. 

International  feedback 

A weekly  influenza  report is received by fax from  Atlanta giving disease occurrence by 
time  and  place.  Data  also  features  in  the  notices  of  influenza  activity  in  the  WHO 
Weekly  Epidemiological  Record. 

Inputs 

Submission  of data by responsible  institutes in participating countries. 

Dates of H commencement  and ii)  completion 

i)  1990 ir) Ongoing. 

Value 

The scheme is critical  for knowing the correct strains to incorporate in vaccines.  When 
allied  to  other  systems  it  could  allows  the  epidemiological  characteristics  of  different 
strains to be evaluated. 

Potentially  a model for international  collaboration in communicable disease surveillance 
influenza 
as  well  as  permitting  the  computation  of  the  velocity  of  spread  of 
internationally. 

26 

8  - Influenza  (EUROGROG) 

Diseases  surveyed 

Laboratory  isolation  of  influenza  virus  or  serological  evidence  of  influenza  infection 
combined with clinical  diagnoses via sentinel  schemes  and other non-specific  indicators 
of  activity 
specific 
pharmaceuticals. 

(eg.  hospital  activity,  sickness  absence,  consumption  of 

Data sources 

Specimens submitted by clinicians to diagnostic laboratories  and various other indicator 
activities within countries. 

International  reporting 

Data is sent by post or fax to the Institut Pasteur in Paris. 

International  feedback 

A weekly influenza bulletin is sent by post from Paris giving activity (disease occurrence 
by week  by country  or French Department)  in 23  countries. 

Inputs 

Submission  of  data by responsible  institutes in participating countries. 

Dates of H commencement  and ii)  completion 

i)  1984 ii) Ongoing. 

Value 

The scheme allows the epidemiological  characteristics of different strains to be evaluated. 

Potentially  a model  for international  collaboration in communicable disease  surveillance 
as  well  as  permitting  the  computation  of  the  velocity  of  spread  of 
influenza 
internationally.  Could lead to more accurate information  on,  and greater harmonisation 
of,  action thresholds. 

27 

9 - European  Working Group on Legionella  Infection  (EWGLI) 

Diseases  surveyed 

Laboratory  evidence  of  Legionellosis  defined  according  to  strict  diagnostic  criteria  in 
patients with a clinical  or radiographic  diagnosis of pneumonia. 

Data sources 

Case  reporting  via  clinicians  and  diagnostic  laboratories  to  responsible  national  co 
ordinating centres within countries. 

International  reporting 

Data  is  sent  by  post,  fax  or  computer  network  to  the  PHLS  Communicable  Disease 
Surveillance Centre (CDSC), London, the centre having been moved  from the National 
Bacteriological  Laboratory,  Stockholm with a view to incorporating the scheme into the 
Early Warning Pilot,  one of the 4  subsidiary  projects  of the European Nervous  System 
(ENS) /CARE Telematics programme, funded by DGXIII to develop European electronic 
communications  networks  (Appendix  VII).  Data  is  obtained  from  Austria,  Belgium, 
Czechoslovakia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, 
Norway,  Portugal,  Spain,  Sweden,  Switzerland,  Turkey,  United  Kingdom,  USSR, 
Yugoslavia. 

International  feedback 

A  computer  disk  is  sent by  post  from  London,  monthly,  giving  disaggregated  data on 
diagnostic  status,  time  (onset  and  report  date),  resort  visited,  period  of  visit,  person 
(characterised by age, sex and country of residence) and institute of report.  Cluster alerts 
are also issued. 

Inputs 

Submission  of  data by responsible  institutes in participating countries. 

Dates of i)  commencement  and ii)  completion 

i)  1987 ii)  Ongoing. 

Value 

Unique  data source  for  some  participating  countries  where Legionellosis  is  not  subject 
to  any  reporting/notification  requirements.  Permits  control  activity  where  clusters 
identified.  Strengthens the efforts  of national  institutions in controlling disease.  Model 
for international  collaborative  effort. 

28 

10 - European Monitoring Group on Meningococci (EMGM) 

Diseases  surveyed 

Meningococcal  meningitis  and septicaemia. 

Data sources 

Case reporting via national  centres with responsibility  for meningococcal  surveillance. 

International  reporting 

Data is sent to King's College  School  of Medicine and Dentistry, University  of London. 
Data  is  obtained  from  Albania,  Austria,  Belgium,  Bulgaria,  Croatia,  Czech  Republic, 
Denmark,  Estonia, Finland,  France,  Germany,  Greece,  Hungary,  Iceland,  Ireland,  Italy, 
Latvia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovak Republic, 
Slovenia,  Spain,  Sweden,  Switzerland,  Turkey, United Kingdom,  Yugoslavia. 

International  feedback 

Periodic reports are provided giving incidence by country by year.  Data on age, outcome 
and prophylactic and curative therapy is also provided.  Data on serogroups and subtypes 
from  reference  laboratories and sulphonamide  resistance is also given. 

Inputs 

Submission of data by responsible institutes in participating countries.  The co-ordinating 
centre is funded by the UK National  Meningitis Trust (a charity). 

Dates of i")  commencement  and ii)  completion 

i)  1991? ii) Ongoing.  Application to the EC is intended. 

Value 

Standardisation of surveillance and laboratory techniques and reagents.  Development  of 
an audit process for meningococcal  disease management  in Europe. 

29 

11 -  WHO Collaborating  Centre for  Rabies  Surveillance  and Research 

Diseases  surveyed 

Human  and  animal  rabies. 

Data  sources 

Case  reporting  via  clinicians,  veterinary  surgeons  and  diagnostic  laboratories  to 
responsible  national  co-ordinating  centres within  countries. 

International  reporting 

Data  is  sent  to the  WHO  Collaborating  Centre  for  Rabies  Surveillance  and  Research  at 
the Federal Research  Centre for  Virus Disease of Animals, Tubingen,  Germany.  Data is 
obtained  from  Austria,  Belgium,  Bulgaria,  Croatia,  Czechoslovakia,  Denmark,  Estonia, 
Finland,  France,  Germany,  Greece,  Hungary,  Iceland,  Ireland,  Italy,  Latvia,  Lithuania, 
Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Russia,  Slovenia,  Spain, 
Sweden,  Switzerland,  Turkey,  United  Kingdom,  Yugoslavia. 

International  feedback 

A  quarterly  report  is produced  tabulating  cases by  species, by  district,  by  quarter. 

Inputs 

Submission  of  data by  responsible  institutes  in  participating  countries. 

Dates of  i) commencement  and  ii)  completion 

i) ? ii)  Ongoing. 

Value 

Identifies  changes  in  epizootic  cycle.  Informs  animal  immunisation  programmes  and 
decisions  on  offering  immune  prophylaxis  to humans. 

30 

12 - European Centre for  the Epidemiological Monitoring of AIDS 

Diseases  surveyed 

AIDS  and HIV infection. 

Data sources 

Every  three months the  national  representatives  in  charge of  AIDS  surveillance 
systems provide  individual  anonymous  data on  diagnosed  AIDS  cases.  Data from  HIV 
seroepidemiological  studies,  including  information  on  methods  and  results,  are  also 
provided. 

International  reporting 

All the countries in the WHO European Region, including all the European Union 
Member  States, participate  in the  surveillance  system.  A  uniform  AIDS  case  definition 
and standardised methods of data transmission are used. The Centre collects, analyses and 
disseminates results at European level. 

International  feedback 

The data collected are recorded in quarterly reports which include updated results 
of AIDS surveillance and various articles from seroepidemiological  surveys or European 
multicentre  studies.  There  are separate quarterly  reports for the WHO European  region 
and  for  the  European  Union  countries.  Twice  a year,  the  EU  report  includes  detailed 
information for each country. Scientific publications are produced by the Centre and also 
by other users of the data sets which are available to surveillance and research teams of 
participating countries. 

Inputs 

Data  are  sent  to  the  Centre  on  diskettes  or  by  E-mail.  Representatives  of  the 
participating  countries  receive  copies  of  the  compiled  data  sets  (quarterly)  and  sets  of 
slides presenting the data (twice a year). The quarterly reports are distributed to a network 
of  900  correspondents.  Standardised tables are also available  on Internet. 

Dates of i)  commencement  and ii)  completion 

i)  1984 ii)  ongoing 

Value 

The  Centre regularly  provides  standardised  information  allowing  the  evaluation 
of the HIV/AIDS  epidemic  situations and trends at European level.  It reinforces  efforts 
of national  and international  institutions to control  the epidemic and is a working model 
of international  collaboration. 

31 

B  -  Training 

1 - Institut pour  le Développement de  l'Epidémiologie Appliquée  (IDEA) 

Participants 

Public health  professionals. 

Duration and Locations 

3 weeks at Veyrier du Lac, France. 

Subject matter 

Field  epidemiology  including  a  surveillance  project  (usually  a  knowledge,  attitudes, 
practice survey). 

Instruction is in French. 

Assessment  (including formal  qualifications  awarded) 

Those who complete the course receive a certificate  of completion. 

Benefit  to participants 

Enhancement of abilities in field  investigation. 

Value 

Additional  practical  skills to organisation  sending student. 

Dates of i) commencement  and ii)  completion 

i)  1984 ii) Ongoing. 

32 

2  -  Seminars on Infectious Disease,  Communicable Disease for  Environmental Health, 
Surveillance of Infection. 

Participants 

Public Health Professionals:  c40/seminar. 

Duration  and Locations 

5  days: Glasgow (UK). 

Subject matter 

Epidemiology  and control  of infection  suitable  for an international  audience. 

Assessment (including formal  qualifications  awarded) 

None. 

Benefit  to participants 

Exchanges of ideas and establishment  of  international  working relationships. 

Value 

Establishment  of avenues for information  exchange. 

Dates of i)  commencement  and ii)  completion 

i) Longstanding  ii) Ongoing 

33 

C  -  Information 

Eurosurve il lance: European Communicable Disease Bulletin 

Diseases 

Communicable diseases. 

Data sources 

Articles  published  in  national  bulletins  of  the  European  Union  Member States, 
original  articles  regarding  investigation  or  of  recent  outbreaks  reports,  review  articles 
based on European data. 

International  reporting 

The production of the bulletin is coordinated by a French-English permanent team. 
The scientific  committee is composed of members of the National Public Health Centre 
and the European Centre for the Epidemiological  Monitoring of Aids in France, and of 
the  PHLS  -  Communicable  Disease  Surveillance  Centre  in  England.  The  15  Member 
States of the European Union are represented by editors of national surveillance bulletins 
or by  surveillance  representatives  in the case  of  Member  States without such bulletins. 
They compose the editorial board. 

International  feedback 

A  French-English  pilot  issue  was  published  and  distributed  to  professionals 
involved  in public health in  1995  (12 000  recipients).  An electronic version was set up 
on Internet. Monthly routine production should follow the feasibility  study conducted in 
1995, which was funded  by DGV  of the Commission  of the European Communities. 

Inputs 

Two meetings of the editorial board and six meetings of the scientific  committee 
each  year,  to  select,  appraise  and  finalise  articles.  Regular  contacts  by  fax  or  E-mail 
ensure close collaboration within the network. The publishing and mailing of the bulletin 
are carried out by the European  Centre for the Epidemiological  Monitoring  of Aids. 

Dates of  i)  commencement  and ii)  completion 

i)  1995  ii)  1998  (for the project submitted  to the Commission) 

Value 

The  feasibility  study  revealed  genuine 

interest  from  readers  (evaluation 

questionnaire)  and the European collaborators. 

34 

Eurosurveillance  aims at increasing the circulation  of information  in the field of 
communicable  diseases  epidemiology  between  national  surveillance  systems  and 
professionals  involved  in  Public  Health  within  the  European  Union.  Moreover,  the 
establishment  of  close,  regular  contacts  between  experts  in  charge  of  national 
communication  should develop the  quality  and speed  of information  exchanges beyond 
the bulletin itself and should contribute to better control  of communicable diseases in the 
European Union. 

35 

D  -Other 

Research  in Methodologies  of Immunisation  Programmes Management  in  Europe 

Diseases 

Diphtheria,  Tetanus, Pertussis, Poliomyelitis,  Measles,  Mumps, Rubella. 

Activity 

National Immunisation Programme Managers have met together to expedite developments 
in three areas: 

1  Methods used to assess vaccine  coverage. 

2  Assessment  of  surveillance  methods used to detect  adverse reactions. 

3  Investigation of outbreaks of vaccine preventable disease (predominantly to concentrate 

on measles). 

International  co-ordination 

International  Children's Centre, Paris. 

Inputs 

Funded  as EC Concerted Action. 

Dates of  i)  commencement  and ii)  completion 

i)  1991  ii)  Ongoing 

Value 

Pooling  of  structural  and process  data from  participating  countries.  Allows  sharing  of 
experience and notice to be given  of potentially  helpful  technologies (ie salivary testing 
for  anti-measles antibodies). 

36 

II - PLANNED  COLLABORATIONS 

A -  Surveillance 

1 - SALMNET 

Diseases  to be surveyed 

Laboratory  confirmed  human  Salmonella  infection. 

Data sources 

Reporting from the responsible national collaborating centre to the European coordinator. 
Discussions  and exchange  of  isolates is being co-ordinated  by the PHLS Central Public 
Health Laboratory,  London, to harmonise phage typing  on a European basis. 

International  reporting 

Reporting would be by regular submission of a floppy disk to the European coordinator 
by  each  collaborating  centre.  An  exploratory  workshop  in  London  was  attended  by 
representatives  from  Austria,  Belgium,  Denmark,  France,  Germany,  Ireland,  Italy, 
Netherlands,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom. 

International  feedback 

An  aggregate  database  would  be  created  and  returned  to  each  country.  The  PHLS 
"Exception Reporting  Scheme" will  be used to analyse the data to identify  anomalously 
high levels  of isolation  and facilitate  outbreak recognition. 

Date of  i)  commencement 

i)  1993.  The  programme  has  been  fundend  as  an  EC  Concerted  Action  under  the 
BIOMED1  Scheme (Science, Research and Development).  The programme is intended 
to become one of the communicable  disease components of the Early Warning Pilot  (ie 
application),  one  of  the  4  subsidiary  projects  of  the  European  Nervous  System  (ENS) 
/CARE  Telematics  programme,  funded  by  the  Commission  to  develop  European 
electronic communications networks. 

Value 

Identification  of  European  wide  Salmonella  problems.  Enhancement  of  the  ability  to 
detect multi-state  outbreaks.  Harmonisation  of reference  techniques. 

37 

2  -  CARE. ENS  Influenza  Surveillance 

Diseases  to be surveyed 

Laboratory  isolation  of  influenza  virus  or  serological  evidence  of  influenza  infection 
combined  with  clinical  diagnoses via  sentinel  schemes. 

Data  sources 

Reporting from the responsible national collaborating centre to the European coordinator. 

International  reporting 

Reporting would be by computer network to the European coordinator at Université Citi 
2,  Paris, by each collaborating  centre. 

International  feedback 

It is  intended  that  a disaggregated  database will  be  created  for  online  interrogation  by 
participants in the network. 

Date of i)  commencement 

i)  1990.  The  programme  is  intended  to  become  one  of  the  communicable  disease 
components of the Early Warning Pilot, one of the 4 subsidiary projects of the European 
Nervous  System  (ENS)  /CARE  Telematics  programme,  funded  by  the  Commission  to 
develop European  electronic  communications networks. 

Value 

May  expedite  data feedback. 

38 

3  -  WHO Global  Surveillance  Programme for  Recognition  and Response  to  Emerging 
Diseases. 

Diseases to be surveyed 

New,  emerging  or re-emerging  diseases and drug resistant micro-organisms. 

Data sources 

Enhanced laboratory reporting at country level to the existing WHO collaborating centres, 
which will  be strengthened. 

International  reporting 

This will  be to WHO Headquarters  at Geneva  (Division  of  Communicable-Diseases in 
close co-ordination with Divisions of Epidemiological  Surveillance, Health Situation and 
Trend Assessment  and Emergency  and Humanitarian Action). 

Reporting  of  bacterial  resistance  to  antibiotics  would  be  by  computer  network 
(WHONET). 

International  feedback 

To be developed. 

Date of  i)  commencement 

i)  1994. 

Vajue 

-

Enhancement  of  capabilities  at  country  level.  Development  of  stronger  intervention 
capacity at WHO/HQ level to facilitate prompt, co-ordinated action.' Training components 
will  be incorporated  and research opportunities will  develop. 

39 

4 - European Study Group on Haemolytic  Uraemic  Syndrome 

Diseases  to be surveyed 

Clinical  diagnoses  of  haemolytic  uraemic  syndrome  and  laboratory  isolations  of  VT+ 
Ecoli 

Data sources 

Paediatric dialysis units and diagnostic  microbiology  laboratories. 

International  reporting 

Some reporting is already carried out by post to the University of Wurzburg in Germany. 
Italy submits some data currently.  Interest has been indicated from Belgium^and United 
Kingdom. 

International  feedback 

None  as yet. 

Date of i)  commencement 

i)  Italy and Germany have shared data since  19S8.  The programme had been proposed 
for funding  as an EC Concerted  Action under the BIOMEDl  Scheme  of the European 
Commission  (Science,  Research  and Development). 

Value 

The diseases are of relatively low incidence, although the sequelae are serious.  European 
surveillance  may  expedite risk factor  identification. 

40 

5  - European Network on Congenital  Toxoplasmosis 

Diseases to be surveyed 

Congenital  Toxoplasmosis  for which a clinical  and laboratory based case definitions  are 
to be developed. 

Data sources 

Participating  countries  institutions  are  to  be  asked  to  identify  geographically  defined 
populations  of  pregnant  women  in  urban,  and,  if  possible,  in  rural  areas.  Data  on 
seroprevalence  will  be compared.  A  multi  centre  randomised  trial  of  therapy  has  also 
been proposed and a long term cohort study of the offspring  of women who sero-convert 
in pregnancy. 

International  reporting 

Different  aspects  of  the  work  will  be  reported  to  different  co-ordinating  centres. 
Participating  in  the  inaugural  workshop  were  Austria,  Belgium,  Denmark,  Finland, 
France,  Germany,  Hungary,  Italy,  Netherlands,  Norway,  Poland,  Sweden,  Switzerland, 
United Kingdom.  Overall  co-ordination is from the Statens Seruminstitut,  Copenhagen. 

International  feedback 

None  as yet. 

Date of  i)  commencement 

i)  1993  The  programme  has  been  funded  as  an  EC  Concerted  Action  under  the 
BIOMEDl  Scheme of the Commission  (Science,  Research and Development). 

Value 

Analysis of data from a variety of localities will give indications as to routes of infection. 
Standardisation and quality  assurance at a European level becomes possible of  diagnosis 
and  treatment.  Resolving  uncertainties  about  the  outcomes  of  treatment  may  be 
expedited. 

41 

6  - Nordic  countries  case-control study  of  listeriosis 

Diseases to be  surveyed 

Listeriosis. 

Data sources 

Physicians in participating countries will  make a notification  of listeriosis to the national 
institute  for  infectious  disease  control  by  fax.  Data  is  tabulated  by  year by  county  by 
person  (characterised  by  age,  sex,  occupation,  clinical  disease  status  and  whether 
pregnant). 

International  reporting 

Data will  be reported by  computer diskette by post to co-ordinating  centres at Oslo and 
in  Uppsala  University.  Participating  countries  will  be  Denmark,  Finland,  Norway, 
Iceland. 

International  feedback 

None as yet.  Format to be decided. 

Date of i)  commencement 

i)  1991  (Planning) 

Value 

Increasing  the  understanding  of  the  contributory  factors  to  disease  development  and 
spread. 

42 

B -  Training 

European  Field  Epidemiology  Training Program 

Participants 

Medical, Veterinary and Public Health Graduates from  European countries.  Initially  6-12 
in  number. 

Duration  and  Locations 

1 month theoretical training at a rotating location followed  by 22 months field attachment 
in  a country  other than  that  from  which  the  student  comes. 

Subject  matter 

Applied  epidemiology  of  Communicable  Diseases  and  Environmental  Hazards. 

A working knowledge of English  and the language of the country where field attachment 
is to be performed  is required in practice although languages will not be used as a criteria 
for  admission  to the course. 

Assessment  (including  formal  qualifications  awarded) 

None  although  certain  educational  objectives  will  be  set  such  as the  ability  to: 
1) Influence  decision  makers  in  Public  Health. 
2)  Assume  service  responsibility  in  epidemiology  and  respond  to disease  clusters. 
3) Develop  and  maintain  an  international  perspective. 

Benefit  to  participants 

Comprehensive training in field epidemiology  and decision making in acute Public Health 
problems. 

Value 

Development  of a cadre of professionals  with a commitment  to addressing Public Health 
problems  at the European  level. 

Develop  a common  approach  to many  problems based  on a common training which will 
facilitate  harmonisation  of  approaches  to  problems  and  decision  making  in Europe. 

Date  of  i)  commencement 

i)  1995 probably  represents the  earliest  practicable year  in which  students can be  taken. 

43 

Proposal  for  a 

EUROPEAN  PARLIAMENT  AND  COUNCIL  DECISION 

creating  a network  for  the  epidemiological  surveillance 
and  control  of  communicable  diseases 
in  the European  Community 

M L/ 

EXPLANATORY  MEMORANDUM 

1 

2 

i 

In its communication  COM(93) 559 of 24 November  1993 on the framework  for 
action  in  the  field  of  public  health,  the  Commission  outlined  the  principles  and 
strategies to be followed  in  implementing  Community  activities directed  towards 
the  attainment  of the health  protection  objectives  laid  down  by Articles 3(o) and 
129  of  the  Treaty  establishing  the  European  Community.  The  role  of  the 
Community  is to underpin  the  efforts  of  the  Member  States  in the  public  health 
field, to assist in the formulation  and implementation  of objectives  and strategies, 
and  to  contribute  to  the  continuity  of  health  protection  provision  across  the 
Community,  setting  as  a  target  the  best  results  already  obtained  in  a given  area 
anywhere  in the  Community. 

In  accordance  with  Article  129  of  the  Treaty  establishing  the-  European 
Community, the Commission presents proposals for the adoption by the European 
Parliament  and the Council  of incentive measures intended  to contribute towards 
ensuring  a  high  level  of  human  health  protection.  These  measures  are  geared 
towards encouraging  cooperation  between  the Member  States, lending  support  to 
their  actions  and  promoting  coordination  of  their  policies  and  programmes,  and 
towards  fostering  cooperation  with  third  countries  and  with 
international 
organisations  competent  in the  sphere of public health.  This present  Commission 
proposal,  based  on  Article  129  and  already  announced  in  the  Commission's 
programme  of  work  for  1995,  comes  under  the  principle  of  shared  competence 
between the Community  and the Member States and seeks to create a network  for 
the  epidemiological  surveillance  and  control  of  communicable  diseases  in  the 
European Community. Full participation by the Member States in the organisation 
and implementation  of the network should help to ensure coordination and mutual 
cooperation  in the  collection,  processing  and  exchange  of  information  necessary 
for the prevention and control  of communicable diseases. This Community  action 
is therefore  geared  towards  disease  prevention  and  will  follow  the  principles  of 
subsidiarity  and  proportionality. 

Infectious  diseases  caused  by  various  microbial  agents  tend  to  spread  through 
populations  and through  space, essentially  as a result of the movements of people 
and,  to  a  lesser  extent,  the  movement  of  goods  and  the  distribution  of  drinking 
water and foodstuffs.  Additional factors include climatic change (global warming), 
increased  resistance  to  antibiotics,  the  immunological  status  of  individuals,  and 
living  conditions (socio-economic  problems).  The more that people travel  about, 
and the further  they travel, the greater the risks of these diseases spreading  in the 
form  of epidemics  and,  as a corollary,  the greater the health risks to populations. 
From  Asian  flu  and  cholera,  to  the  HIV  virus  responsible  for  AIDS,  examples 
abound  both  in  history  and  in  the  present  day.  The  agents  responsible  for 
communicable  infectious  diseases  know  no  geographical  frontiers.  And  despite 
substantial  progress  in  the  field  of  public  health  protection,  the  exposure  of 
populations  to the  risk  of  contracting  these  diseases  is increasing  all  the  time. 

^s 

In  order  to  take  the  appropriate  measures  necessary  to  block  the  progression  of 
these  infectious  diseases  or  prevent  their  appearance,  national  health  authorities 
clearly  need  to  have  as  precise  a  picture  as  possible  of  the  epidemiological 
situation.  This  can  only  be  achieved  through  the  systematic  collection,  analysis 
and interpretation  of data on these diseases, followed  by dissemination  of the data 
to  those  responsible  for  public  health.  Taken  together  these  activities  amount  to 
epidemiological  surveillance,  an  essentially  practical  process the aim  of which  is 
to  produce  information  so  that  swift  action  can  be  taken.  In  the  case  of 
communicable  diseases  all 
is 
surveillance,  with  the  results  being  used  in  order  to  control  and  prevent  these 
diseases. Epidemiological  surveillance  has proved  its worth  over and  over  again, 
the  outlay  required  being  amply  repaid  by  the  savings  made  in  terms  of  disease 
avoidance. 

the  specialists  agree 

that  the  cornerstone 

In  this  general  context,  if  we  look  at  the  European  area  as  a  single  entity  it  is 
obviously  essential  to  standardise  communicable  disease  surveillance.  In  this 
respect  the  Council  and  the  Ministers  for  Health  of  the  Member  States  meeting 
within the Council  adopted  on  13 November  1992 a Resolution, No 92/C  326/1 \ 
inviting the Commission to report briefly  on the existing arrangements established 
between  the Member  States  or by the World  Health  Organisation  (WHO) for  the 
surveillance of communicable  diseases, including food-borne  diseases; to  identify 
needs and shortcomings; and to put forward  proposals for improvements. And the 
European  Parliament,  in  its Resolution  on  public  health  policy  after  Maastricht2, 
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. Additionally,  in its Conclusions No  94/C 
15/04  of  13  December  19933,  the  Council  requested  the  Commission  to  put 
forward  proposals  for  the  setting  up  of  an  epidemiological  network  in  the 
Community.  In  its  Communication  COM(93)  559  of  24 November  1993  on  the 
framework  for  action  in  the  field  of  public  health  and  its  Communication 
COM(94)  413  of  9  November  1994  on  AIDS  and  certain  other  communicable 
diseases, the Commission  proposed  specific  Community  measures in this respect, 
notably  the  creation  and  development  of  surveillance  networks.  To  this  end,  the 
Commission  proceeded to consult outside experts, including both national  experts 
competent  in  the  surveillance  and  control  of  communicable  diseases  and  senior 
officials  of the national  Health Ministries sitting on the High Level Committee on 
Health,  and  has taken  their  comments  fully  into  account. 

Consequently,  this proposal  seeks to  establish  a  system  of close cooperation  and 
effective  coordination  between  Member  States  in  the  field  of  surveillance,  both 
routine  and  emergency,  with  a  view  to  improving  the  prevention  and  control  of 
a  certain  number  of  serious  communicable  diseases  which  necessitate  the 

OJ  of  11.12.1992 
OJ No  C  329, 6.12.1993, p.  375 
OJof  18.1.1994 

He 

introduction  of  measures  for  the  protection  of  populations.  The  proposal  is 
modelled  on  Community  instruments  already  adopted  in  similar  areas  for  the 
accomplishment  of  similar  objectives.  The  data  in  question  will  be  collected  in 
aggregated  form  and  will  and  will  in  no  case  enable individuals  to be  identified. 
Thus, they will  not conflict  with  existing  or forthcoming  Community  instruments 
concerning the protection of personal  data, such as Council  Directive  C 95/46/EC 
of 24 October  1995 on the protection  of individuals with regard to the  processing 
of personal  data and the free  movement of such data4. They will however  comply 
with  the  Community  provisions  concerning  systems  of  information  exchange 
between  administrations.  In  addition,  the  Decision  contains  specific  provisions 
aimed  at  ensuring  cohesion  with  other  relevant  Community  policies,  namely  the 
Common  Agricultural  Policy,  freedom  of  movement  of  goods  and  persons,  and 
exchanges  of  data  between  administrations. 

The setting up of this network for the surveillance of communicable diseases takes 
account of,  and is based on, the situation  already existing in this field at European 
level.  It  also aims to  avoid  unnecessary  duplication  of work  by  ensuring  that  all 
Member  States have  the  same  conception  of  surveillance,  as a result  of  defining 
with  them  the type  of  information  required  and  the arrangements  appropriate  for 
each  group  of  communicable  diseases.  Finally,  other  parties  will  be  associated 
with  the  network,  under  arrangements  yet  to  be  worked  out.  These  will  include 
the  competent  international  organisations,  non-member  countries  (such  as  the 
United  States  of  America,  with  whom  cooperation  is  already  planned),  and  the 
surveillance  networks  to which  Mernber  States  already  belong. 

The implementation  of the decision  will yield  added value in a number  of ways: 

a) 
It  will  ensure  the  setting  up  of  a  system  of  continuous,  well-structured, 
reliable  and  effective  communication  at  Community  level  between  national 
communicable  disease  surveillance  authorities,  something  which  is  lacking  at 
present; 

It will  facilitate  the rapid,  reliable  and  commonly  ajgreed  identification  of 
b) 
cases  of  communicable  diseases  occurring  inside  the  Community,  or  occurring 
outside  and  therefore  being  imported  or  likely  to be  imported; 

It  will  give  the  competent  authorities  the  opportunity  and  the  means  to 
c) 
consult together  on the  preventive  measures to be taken,  and  it will  help them  in 
the  coordinated  introduction  of  such  measures  and  the  evaluation  of  their 
effectiveness; 

d) 
It  will  give  the  authorities  the  support  they  need  for  analysing  and 
interpreting  data and for  deploying the necessary  measures to stop  communicable 
diseases  from  spreading. 

OJ No L 281, 23.11.1995, p.31 

Mi 

The  action  envisaged  can  only  be  undertaken  on  the  basis  of  a  European 
Parliament  and  Council  decision  adopting  the  measures  proposed  for  the  setting 
up of a Community  system  needed to ensure cooperation  between Member  States 
and  coordination  of  their  respective  systems  in  this  area.  It  does  not  require  the 
harmonisation  of  national  laws  and  regulations. 

^ 

Proposal  for  a 

EUROPEAN  PARLIAMENT  AND  COUNCIL  DECISION 

creating  a network  for  the  epidemiological  surveillance 
and  control  of  communicable  diseases 
in  the European  Community 

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, 

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, 

Whereas the European Parliament,  in its Resolution  on public health  policy  after 
Maastricht4,  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, 

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; 

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 ... 
OJ No ... 
OJ No ... 
OJ No C 329, 6.12.1993, p. 375 
OJNoC  165, 17.6.1994, p.l. 
OJNoC  15, 18.1.1994, p. 6. 

M  9 

5 

6 

7 

8 

9 

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  health7,  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; 

Whereas in their resolution of  13 November  19928, 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; 

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; 

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; 

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 
health9  envisages  a  number  of  Community  actions  for  the  creation  and 
development of networks for the control and surveillance of certain communicable 

COM(93) 559 final, 24.11.1993. 
OJNo C326,  11.12.1992, p. 1. 
OJ No  ... 

.To 

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  disea:es 
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/EEC10 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)11 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; 

OJ No L  62,  15.03.93, p. 38. 
O J N o L 2 6 9,  11.11.1995, p.23. 

^1 

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: 

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) 

b) 

the appearance or resurgence on its territory of cases of serious and/or rare 
communicable  diseases  as listed  in the Annex; 

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. 

i"3 

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: 

-  . 

case definitions, in particular the clinical definition and, where appropriate, 
the microbiological  characterisation  of the agent responsible; 

- 

- 

- 

- 

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 epidemiological  and microbiological  surveillance methods; 

the  protective  measures  to  be  taken,  in  particular  at  ports  and airports, 
notably  in emergency  situations; 

information,  recommendations  and guides to good practice for the public; 

r 7 

Article 6 

Each  structure  referred  to  in  Article  1  shall  communicate  to  the  Community 
network and the Commission: 

- 

- 

- 

information on the communicable diseases referred to in Article 2, together 
with information  on control  measures applied; 

any useful  information  concerning  the progression of epidemic  situations 
in the Member  State to which  the institution belongs; 

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/EC 
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). 

rj-

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. 

Done at Brussels 

For the European Parliament 
The President 

For the Council 
The President 

sc 

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: 

influenza  and 

-  diseases  preventable  by  vaccination  (tuberculosis,  tetanus,  poliomyelitis, 
diphtheria,  meningitis,  measles,  mumps,  rubella, 
influenza 
syndromes, etc.), 
-  sexually-transmitted  diseases  (hepatitis  B, AIDS/HIV,  chlamydiasis,  etc.), 
-  viral  hepatitis  (including  hepatitis  C and  other  as yet unclassified  categories  of 
hepatitis), 
-  food-borne  diseases  (listeriosis,  salmonellosis,  etc.), 
-  water-borne  diseases  and  diseases  of  environmental  origin  (legionellosis,  etc.), 
-  nosocomial  infections, 
-  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: 

- diseases covered by the International  Health Regulations (yellow fever,  cholera, 
plague) 
-  other  diseases  (rabies,  typhus  fever,  African  haemorrhagic  fevers,  malaria  and 
any  other  as yet  unclassified  serious  epidemic  disease,  etc.). 

s^ 

FINANCIAL  STATEMENT 

TITLE  OF  OPERATION 

Proposal  for  a European  Parliament  and  Council  decision  creating  a network  for 
the  epidemiological  surveillance  and  control  of  communicable  diseases  in  the 
European  Community. 

BUDGET  HEADING  INVOLVED 

Part A  of the budget. 

LEGAL  BASIS 

a) Actual  legal  basis: 

Article  3(o)  and  Article  129 of the Treaty  on European  Union. 

b)  References: 

Conclusions  of  the  Council  and  the  Ministers  for  Health  of  the  Member  States 
meeting within  the  Council  of  16 May  1989 on the improvement  of the  general 
system  for  collecting  epidemiological  data,  including the application  of the  new 
definition  of  AIDS  cases (OJ No  C  185, 22.7.1989,  p. 7). 

Resolution  of  the  Council  and  the  Ministers  for  Health  of  the  Member  States 
meeting  within  the  Council  of  13 November  1992  on  the  monitoring  and 
surveillance  of  communicable  diseases  (OJNo  C 326,  11.12.1992,  p.  1). 

Commission  communication  on  the  framework  for  action  in  the  field  of  public 
health  (COM  (93)  559  final,  24 November  1993). 

Council conclusions of  13 December  1993 on the setting up of an epidemiological 
network  in the European  Community  (OJ No  C  15,  18.1.1994,  p. 6). 

*8 

DESCRIPTION  OF  OPERATION 

4.1  General  objective 

Implementation  at  Community  level  of  a  system  of  epidemiological 
surveillance in the field of communicable  diseases, to meet the following 
objectives: 

firstly, 

- 
to  ascertain  the  incidence  and  the  characteristics  of  a 
particular infectious  disease or group of diseases, and to study the pattern 
of  spread of  the disease through time, space and social  categories,  so as 
to be able to take appropriate counter-measures; 

- 
secondly, to detect disease clusters or epidemics, or even abnormal 
health  incidents,  so  that  measures  can  be  taken  to  break  the  specific 
transmission chain; 

thirdly,  to describe and measure the risk factors  for  contracting a 
- 
communicable infection, so as to be able to select and implement the most 
appropriate preventive measures and recommendations. 

4.2  Method  employed  for  attaining  these  objectives 

The setting up and running of a system for the surveillance and control of 
communicable  diseases  at  Community  level,  requiring  the  exchange,  at 
appropriate  moments,  of  accurate  and  reliable  information  concerning 
diseases  for  which  specific  case  definitions, 
identifications  and 
verifications  are required. It is proposed to set up this system on the basis 
of  a  European  Parliament  and  Council  decision,  and  to  exploit  the 
infrastructure  set up by the IDA programme. 

4.3 

Period  covered 

- 
- 

Open-ended. 
Implementation  report  to  be  transmitted  to  the  Council  and  the 
European  Parliament  following  the  creation  of  the  network,  and 
further  reports to be transmitted  following  any  adaptations  to the 
system. 

CLASSIFICATION  OF  EXPENDITURE  OR  REVENUE 

Non-differentiated  appropriations. 

S3 

6 

TYPE OF EXPENDITURE OR REVENUE 

Nil 

7 

FINANCIAL IMPACT 

No financial impact  in Part  B of the budget. 

8 

ANTI-FRAUD  MEASURES PLANNED 

Measures in the rules on the reimbursement of travelling and subsistence costs of 
experts  convened. 

9 

ELEMENTS OF  COST-EFFECTIVENESS  ANALYSIS 

9.1 

Specific  and  quantifiable  objectives: 

The  aim  is  to  establish  a  Community  network  for  the  epidemiological 
surveillance  and  control  of  communicable  diseases,  by  achieving  the 
following  objectives: 

- 
setting  up  of  a  system  of  close  cooperation  and  effective 
coordination  between  Member  States  in  the  field  of  surveillance,  both 
routine  and  emergency,  with  a  view  to  improving  the  prevention  and 
control  in Europe  of  a certain  number  of  serious communicable  diseases 
which  necessitate  the  introduction  of  measures  for  the  protection  of 
populations; 

list  of  diseases  and/or  groups  of  diseases  kept under  surveillance 

- 
at Community  level; 

case  definitions,  in  particular  the  clinical  definition  and,  where 
- 
appropriate, the microbiological  characterisation  of the agent responsible; 

the nature  and  type of  data and  information  to be collected  in  the 

- 
context  of  epidemiological  surveillance; 

- 

epidemiological  and  microbiological  surveillance methods; 

protective measures to be taken, in particular at ports and airports, 

- 
notably  in  emergency  situations; 

information,  recommendations and guides to good practice for  the 

- 
public; 

designation  of  the  structure  responsible  for  coordination  for 

- 
particular  diseases  and/or  groups  of  diseases. 

S O 

9.2 

Players  concerned 

The  Member  States'  competent  health  authorities  at  national, 

1. 
regional  and  local  levels,  and  competent  international  organisations. 

Health professionals,  institutions, laboratories and  epidemiological 

2. 
health  services. 

9.3  Grounds  for  the  operation 

As regards  the  setting up  of  a  system  for  the  surveillance  and  control  of 
communicable  diseases  at  Community  level,  the  Commission,  in  its 
communication  of 24 November  1993 on the framework  for  action in the 
field of public health,  outlined the principles and strategies to be  followed 
in implementing  Community  activities  directed towards the attainment  of 
the health protection objectives  laid  down by Articles 3(o) and  129 of the 
Treaty establishing the European Community. The role of the Community 
is to underpin  the  efforts  of the Member  States in the public health  field, 
to  assist  in  the  formulation  and  implementation  of  objectives'  and 
strategies, and to contribute to the continuity of health protection provision 
across the Community,  setting as a target the best results already  obtained 
in a given  area  anywhere  in the  Community. 

The Commission's, proposal  for  the  creation  of  such a network  advocates 
that  the  Member  States  should  participate  fully  in  its  organisation  and 
implementation.  The  network's task  will  be to ensure coordination  in  the 
collection,  processing  and  exchange  of  information  necessary  for  the 
prevention  and  control  of  communicable  diseases.  Focusing  on  disease 
prevention, and following the principles of subsidiarity and proportionality, 
this Community operation is designed to enable the authorities responsible 
for  public  health  to  take,  at  national  level,  measures  to  block  the 
progression  of these  infectious  diseases  or to  prevent their  appearance. 

An  operation  as  extensive  as the  creation  and  development  of  a  network 
which  will  link  the  competent  authorities  of  all  Member  States  can  only 
be undertaken  on  a Community  scale. 

9.4  Monitoring  and  evaluation  of  the  operation 

9.4.1  Monitoring  of  the operation 

The  setting  up  and  functioning  of  the  network  will  be  monitored 
by the  Commission,  which  will  submit reports to the Council,  the 
European Parliament, the Economic and  Social Committee and the 
Committee  of  the  Regions.  The  Commission  will  base  its  reports 
on  the  national  reports  and  on  any  evaluations  carried  out. 

61 

9.4.2  Evaluation 

* Evaluation  will  take the form  of: 

an evaluation of the effective  establishment of the network, 

- 
with  the participation  of  independent  experts; 

reports  on  the  quality  and  effectiveness  of  the  network's 
- 
functioning,  to  be  submitted  by  the  Commission  to  the  other 
Community  institutions. 

* Evaluation  methods  and  intervals: 

establishment  of  regular  reports  on  any  adaptations  which 

- 
may  be  introduced. 

10 

ADMINISTRATIVE  EXPENDITURE  (PART  A  OF  THE  BUDGET) 

The effective mobilisation of the administrative resources required will result from 
the  Commission's  annual  decision  on the  allocation  of  resources,  taking  account 
of  any additional  staff  and  funds  allocated  by the budgetary  authority. 

10.1  Effect  on the number  of  workers 

Types of  workers 

Staff  running  the  operation 

Source  of the  workers 

Duration 

Permanent 
workers 

Temporary 
workers 

DGor 
service 

Additional 
personnel 

Officials,  or 
temporary 
staff 

A 
B 
C 

Other  resources 

Total 

1 
1 
1 

3 

0 

0 

1 
1 
1 

3 

0 
0 
0 

0 

10.2  Financial  impact  of  employing  additional  staff 

Nil 

6d 

10.3 

Increase  in  other  administrative  expenditure  resulting  from  the 
operation 

Budget  heading 

Meetings  A2510 

Amount 

92  650 

Method  of work 

* 4 meetings  of the committee,  2 
representatives/Member  State, 
4  x  30 x  770 Ecus 

The  resources  needed  to  cover  the  expenditure  described  below  will  be 
obtained  by  redeploying  existing  financial  resources;  no  additional 
resources will  be  required. 

Staff  expenditure  (Titles  Al,  A2  and  A5) 

3 x  100 000 Ecus =  300  000  Ecus 

Administrative  expenditure: 

Cost  of  meetings  (A-250) 
3  meetings x  15 experts x  879  Ecus =  39.555 Ecus 

- 

Mission  costs (A-130) 
24 Brussels-Luxembourg  missions  x 200 Ecus = 4 800 Ecus 
30 Member  States missions x  750 Ecus = 22 500 Ecus 

Total: 

366  855  Ecus 

&3 

ISSN 0254-1475 

COM(96) 78 final 

DOCUMENTS 

EN 

05 

Catalogue number  : CB-CO-96-087-EN-C 

ISBN 92-78-00943-1 

Office for Official Publications of the European Communities 

L-2985 Luxembourg