Proposal for a Regulation of the European Parliament and of the Council Establishing a European Centre [for Disease Prevention and Control]
Date: 2003-08-08
Institutions: European Commission
Subjects: EU office or agency, disease prevention, epidemiology, health control, health policy, information network, medical report

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 16.9.2003
COM(2003) 441 final/2

2003/0174 (COD)

Corrigendum: annule et remplace la version EN précédente.

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

Establishing a European Centre [for Disease Prevention and Control]

(presented by the Commission)

EXPLANATORY MEMORANDUM

1.

OVERVIEW

Communicable disease outbreaks can pose a significant threat to the health and well being of
the European Union’s citizens, as shown during the recent spread of the SARS virus (Severe
Acute Respiratory Syndrome) and in the anthrax alerts of late 2001, which were thought to be
due  to  bio-terrorism.  In  a  European  Union  where  millions  of  people  cross  internal  and
external borders each day, tackling health threats requires a much closer co-operation between
Member  States,  the  European  Commission,  the  World  Health  Organisation  and  affected
countries  around  the  world.  The  European  Union  citizens  place  a  very  high  value  on  the
protection  of  their  health.  Communicable  disease  outbreaks,  or  other  threats  such  as  the
deliberate  release  of  chemical  or  biological  agents  from  terrorist  attacks,  can  cause
considerable  anxiety  to  citizens  and  huge  costs  to  society,  even  when  the  number  of  cases
remains  relatively  small.  A  major  outbreak  such  an  influenza  pandemic  could  have
catastrophic  consequences.  The  draft  European  Convention  of  the  future  of  the  European
Union  has  identified  common  safety  concerns  in  public  health  matters  as  an  area  where
Community competencies should be consolidated.

Since  1999,  the  Commission  has  managed  a  Communicable  Diseases  Network.  This  is
currently based on ad hoc cooperation between Member States within the legal framework of
Council  and  Parliament  Decision  2119/98/EC.  However,  there  is  a  need  for  a  substantial
reinforcement  of  this  system  if  the  European  Union  is  to  be  in  a  position  to  control
communicable  diseases  effectively.  In  2000  and  2001,  two  external  evaluations  of  the
Network  highlighted  weaknesses  in  the  functioning  of  existing  structures  and  reviewed
options  for  a  more  effective  response  capacity  at  the  EU  level.  In  2002,  the  State
Epidemiologists from the Member States gave their view on the future of the surveillance of
communicable diseases at the European Union level and favoured the creation of an EU-level
centre. In addition, in 2002, the Network Committee also adopted conclusions favouring the
creation of an EU coordinating centre.

In  June  2001,  the  European  Council  meeting  in  Gothenburg  asked  that  the  possibility  of
creating a European surveillance and early warning system on health issues be examined. At
the Council meeting of 15 November 2001, following agreement by the Health Ministers, the
Belgian Presidency issued conclusions which requested the Commission to develop an action
programme  of  cooperation  on  preparedness  and  response  to  biological  and  chemical  agent
threats  from  their  deliberate  release.  The  European  Union's  Employment,  Social  policy,
Health  and  Consumer  Affairs  Council,  at  an  extraordinary  meeting  held  on  6  May  2003  to
discuss  SARS,  and  at  its  2  June  2003  meeting  recognised  the  need  to  strengthen  the  EU
preparedness to deal with disease outbreaks within its borders. The Commission's intention to
propose legislation creating a European Centre for disease prevention and control was widely
supported.

The  present  proposal  aims  at  creating  a  European  Centre,  able  to  provide  a  structured  and
systematic approach to the control of communicable diseases and other serious health threats,
which  affect  European  Union  citizens.  The  creation  of  a  European  Centre  for  Disease
Prevention and  Control,  an  independent  European  agency,  would  mobilise  and  significantly
reinforce the synergies between the existing national centres for disease control.

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In future, the Centre will take over the existing operational instruments provided by Decision
2119/98/EC (networks), whilst the Commission will continue to be responsible for its residual
legislative provisions (setting technical and procedural requirements).

The  Centre  will  operate  the  Community  network  of  national  competent  authorities  or
institutes  mentioned  in  Decision  2119/98/EC  as  well  as  its  dedicated  surveillance  networks
dealing  with  specific  diseases  (AIDS,  TB,  influenza,  etc…).  The  Centre  will  also  steer  the
technical work to be conducted between national institutes, which requires shared ownership
of objectives, tasks and operations and pooling of resources at EU-level. The European Centre
will  encourage  this  shared  ownership  and  facilitate  the  joint  use  of  skills  and  resources  to
discharge common responsibilities in fighting serious health threats.

The Commission will maintain its’ overall supervision and existing legislative powers under
Decision 2119/98/EC in order to set technical requirements and procedural obligations, which
will have to be implemented and used by all the components of the Community Network. The
Commission will work in close consultation with the Member States through the Regulatory
Committee (the so-called ‘Network Committee’). The Centre will provide EU policy makers
and citizens with authoritative and independent scientific advice on serious health threats and
recommend  control  measures  to  the  Commission  and  national  authorities.  They  in  turn  will
then decide on the appropriate risk management response, thus enabling a rapid and effective
EU-wide response.

The Centre, either on request of the Commission or on its own initiative, will issue scientific
opinions and risk assessments on a wide spectrum of issues related to communicable diseases,
such as clinical medicine, epidemiology, microbiology, and preventive measures. It will do so
by setting up scientific panels to address specific issues that are not covered by the existing
scientific excellence and expertise from the dedicated surveillance networks.

2.

INTERNATIONAL HEALTH THREATS IN THE 21ST CENTURY

Communicable disease has always been one of the major threats to human health. What has
changed  in  the  past  few  years  is  the  growing  realisation  that  natural  outbreaks  of
communicable disease can still threaten both  technologically advanced  regions of  the  world
such  as  the  European  Union  as  much  as  developing  regions  of  the  world  with  little  health
infrastructures. The possibility exists that a communicable disease outbreak could be started
deliberately ("bio-terrorism"). In our increasingly interconnected and global world, a disease
outbreak in one country can be spread internationally in a matter of hours or days. This “new
threat” and the need for a comprehensive EU approach to it, was also identified in the security
strategy paper that was presented by the High Representative for the CFSP, Javier Solana, to
the Thessaloniki European Council (“A secure Europe in a better world”).

In  controlling  a  disease  outbreak,  time  is  of  the  essence.  Every  day  lost  in  identifying  the
threat,  deciding  on  control  measures  and  implementing  them  can  result  in  the  outbreak
spreading  further.  These  lost  days  can  mean  the  difference  between  a  small  outbreak  and  a
serious  epidemic.  If  the  disease  or  pathogen  involved  is  particularly  lethal,  then  delay  may
cost lives.

Speed of reaction is of particular importance within the European Union. Products and people
flow freely between EU Member States and controls have been abolished at internal borders.
A  small  communicable  disease  outbreak  in  one  country  can  become  an  international  public
health threat if national control measures are ineffective: for example, if a disease outbreak is

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not  detected  and  contained  in  a  timely  way,  if  national  authorities  give  out  inconsistent  or
incomplete  information,  or  even  fail  to  notify  other  countries  of  the  outbreak.  Through
migration or tourism, the SARS virus was able to spread in just in a few weeks from China to
Europe,  the  Americas,  and  Asia.  SARS  was  spread  internationally  by  the  movement  of
infected people. Since the deliberate release of anthrax in the US in late 2001 security services
and  authorities  responsible  for  civil  defence  are  taking  the  threat  of  “bio-terrorism”  attacks
very seriously.

Lack of  appropriate  co-ordination  structures  regionally  and  internationally  can  contribute  to
this  problem.  A  rapid,  effective  and  co-ordinated  response  to  health  threats  is  therefore
critical. In the SARS outbreak the shortcomings of present model of disease control were well
demonstrated. Delayed detection of an ongoing outbreak allowed the virus to be spread by air
travel from China to Canada, where an infected traveller was able to spread the virus among
health care personnel in a Toronto hospital. Only after the WHO issued global health alert on
March 12th, 2003, when the public as well as health professionals were informed about SARS,
could measures to contain its spread be properly implemented. In the case of SARS, however,
without international collaboration between health experts it would not have been possible to
identify the virus and gather knowledge about its epidemiology in such a short time.

Major  communicable  disease  outbreaks  impact  the  whole  of  a  society,  not  just  its  health
sector.  For  instance,  the  SARS  outbreak  had  an  immediate,  negative  impact  on  economic
growth  in  the  Asian  countries  it  affected.  SARS  may  also,  more  indirectly,  have  had  a
negative  impact  on  the  EU  economy.  Taking  rapid  and  effective  action  against  a  disease
outbreak, and thus being able to reassure  citizens that the outbreak has  been contained,  will
protect Member States' economies, as well as their public health.

3.

LIMITATIONS OF THE CURRENT COMMUNITY NETWORK’S ACTIVITIES

Under Article 152 of the Treaty, the European Community recognised the need to work more
effectively  on  public  health  threats.  The  Community  Institutions  gave  this  practical  effect
with the adoption  of the  Council and the  European Parliament Decision 2119/98/EC  setting
up  a  network  for  the  epidemiological  surveillance  and  control  of  communicable  diseases  in
the European Community. This Decision envisaged the creation of Europe-wide surveillance
and early warning and response mechanisms.

As  far  as  early  warning  and  response  is  concerned,  the  Network  has  partially  fulfilled  its
coordinating role, but has not been able  to fully follow up on the required technical  actions
and  interventions.  For  epidemiological  surveillance,  specialists  from  the  national  institutes
concerned,  who  already  survey  each  disease  group,  were  asked  to  create  the  so-called
dedicated  surveillance  networks  (DSN).  Together  these  form  the  ‘network  of  networks’,
which constitute the basis on which the Community network functions.

The Commission’s role in coordinating activities has been limited to operating the system of
EU  subsidies  that  co-finances  the  dedicated  surveillance  networks,  and  designing  and
operating  the  telematic  pilot  system  on  the  Early  Warning  and  Response  System
(HSSCD/EUPHIN).  The  Commission  has  barely  the  financial  and  technical  resources
necessary  to  fulfil  these  functions.  The  Network  Committee  has  been  utilised  for  scientific
advice  and  coordination  purposes  in  ways  that  go  far  beyond  the  limited  regulatory  role
foreseen for it in the 1998 Decision. The  growing demands being  placed  on  the  Committee
demonstrate the pressing need for a substantial reinforcement of resources if the expectations
for health protection at EU level are to be met.

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The  basic  formula  for  cooperation  amongst  Member  States  and  the  Commission  in  the
framework  of  Decision  2119/98/EC  is  not  being  questioned.  What  is  required  is  a  much-
extended  capacity  to  provide  independent  scientific  advice  and  effective  operational
coordination.  Both  the  disease  surveillance  and  the  early  warning  and  response  activities
needs more trained specialists to assess, investigate, and analyse outbreaks across Europe and
abroad, particularly when there is a significant potential threat to the health of EU citizens. In
some  outbreaks,  there  have  been  several  investigation  teams  from  different  Member  States
investigating the same phenomena with slightly different methodologies, sending samples to
different laboratories, and finally each of them reporting separately.

It has become evident that the Community Network cannot develop much further without new
structures and arrangements to support Member States and the Commission in fulfilling their
tasks. The more diseases the Network covers with the ‘dedicated surveillance networks’, the
more the risk of fragmenting its structure has become apparent. These dedicated surveillance
networks  have  been  financed  using  annual  subsidies  from  the  Public  Health  Action
Programme, in competition with many other projects. With ten new Member States in 2004 it
will  be  impossible  to  continue  with  the  existing  structures  and  resources  if  surveillance
activities  in  the  Member  States  (and  other  partner  states  in  the  dedicated  surveillance
networks) are to be continued efficiently.

The ability to respond to an international health threat is profoundly influenced by the extent
to which relevant issues have been studied in advance, and whether preparedness plans are in
place  for  co-ordinated  action.  To  address  the  threat  of  influenza,  the  World  Health
Organisation  (WHO)  has  been  working  on  a  global  pandemic  plan,  to  facilitate  the
development  of  national  plans.  A  complementary  EU  level  preparedness  plan  is  needed  to
facilitate  the  exchange  of  information  between  the  European  Community's  laboratory  and
surveillance  networks  and  to  ensure  that  appropriate  vaccines,  antiviral  agents  and  other
materials can be made available rapidly. A European Centre could harness all these measures
in a coherent and cost-effective way.

4.

THE  EUROPEAN  UNION  NEEDS  A  CENTRE  FOR  DISEASE  PREVENTION  AND
CONTROL

The  public  health  responsibilities  of  the  European  Union  have  increased  substantially,  with
the implementation of  the  Amsterdam  Treaty  and with  rising  expectations on  the  part  of  its
citizens.  This  is  reflected  in  many  ways  in  the  demands  put  on  the  Member  States  and  the
Commission  to  cooperate  more  closely  both  at  EU  level  and  internationally.  Recent  health
threats have illustrated that one Member State alone does not generally have all the expertise
available to address all possible aspects of a threat. It is only through intense and constructive
international collaboration that the necessary expertise can be assembled. The added value is
not only coordination but also pooling the expertise.

During  the  last  three  years,  the  Commission  has  initiated  three  external  evaluations  on  the
performance and improvements to be introduced in the operation of the Community network
for communicable diseases (http://europa.eu.int/comm/dgs/health_consumer/index_en.htm).

The  first  evaluation  produced  in  September  2000  by  the  Institute  of  Public  Health,  North
Rhine  Westphalia,  with  the  London  School  of  Hygiene  and  Tropical  Medicine  and  Public
Health  Laboratory  Services  (UK),  focused  on  the  weak  points  in  the  functioning  of  the
existing  structures,  analyzing  transnational  outbreaks  of  5  diseases.  It  requested  the
Commission to put in place a framework for long term stability and sustainability of existing

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and new disease specific networks  and  recommended  the  development  of  some  15  types  of
actions at Community level which are  all  supporting the principles addressed  in  the  present
proposal.  These  cover  such  issues  as  EU  level  preparedness,  EU  coordination  of  outbreak
investigations, and provision of assistance by experts on behalf of the European Union.

The second evaluation was completed in December 2001 by the Belgian Scientific Institute of
Public Health in consultation with epidemiological institutes from all Member States, Norway
and  the  WHO.  It  demonstrated  the  willingness  and  preparedness  of  the  national  competent
bodies  to  participate  in  setting  up  a  Community  response  capacity.  It  supported  a  strong
central  coordination  mechanism  supported  by  European  technical  co-ordination  structure
outside the Commission but financed by the Community budget and starting on a pilot scale
as soon as possible.

Thirdly, in June 2002, the State Epidemiologists from the Member States gave their view to
the Commission on the future of the surveillance of communicable diseases in Europe. They
confirmed the coordination tasks identified in the two previous studies and concluded in favor
of sufficiently resourced permanent technical coordinating structure at European level. They
held the same view at a public seminar held in November 2002 in Brussels under the auspices
of the European Parliament.

In  line  with  Decision  2119/98/EC  the  Commission  conducted  an  internal  evaluation  of  the
operation  of  the  Community  network  during  2002  and  submitted  it  to  the  Network
Committee.  The  Committee  endorsed  the  recommendations  on  the  tasks  to  be  preferably
transferred  to  a  European  coordinating  Centre.  The  Committee  also  considered  the
Commission did not have enough access to well trained specialist staff and that Commission
arrangements for networking, surveillance and early warning would therefore be insufficient.
The running of an internal operation in the Commission services would not be less costly and
would not create the sense of shared ownership, which an independent centre would provide.

These  orientations,  already  mentioned  in  the  conclusions  of  the  European  Council  at
Gothenburg in June 2001, were reiterated during the extraordinary meeting of the Council of
the  European  Union  (Employment,  Social  policy,  Health  and  Consumer  Affairs)  on  6  May
2003  and  their  subsequent  meeting  on  2  June  2003,  where  the  idea  of  creating  a  European
Centre for disease prevention and control was widely supported.

Member  States  epidemiological  centres  must  have  a  privileged  place  in  this  cooperation.  It
will  probably  be  from  their  resources  that  most  of  the  exchanges  of  cooperation  will  take
place.  For  example,  their  officials  are  likely  to  be  essential  partners  in  running  dedicated
surveillance  networks,  training  actions,  and  intervention  teams.  The  existence  of  such
resources  in  the  Member  States  means  that  a  large  European  Centre  is  not  needed.
Arrangements  to  give  the  Centre  access  to  resources  in  national  centres  will  be  the  key  to
keeping  the  Centre  a  relatively  small,  but  effective,  coordinating  entity.  The  Centre  will
provide  a  structure  enabling  experts  from  different  Member  States  to  work  together,  for
example, in WHO global outbreak investigation teams, and facilitating the subsequent sharing
of results. The Centre would work with national public health institutes in equal partnership.

The Centre would allow quick mobilisation of expert staff from the Member States to be used
in European Community intervention teams for epidemiological investigation, and for on site
check  ups  and  risk  assessments.  There  would  be  a  core  technical  expertise  in  the  Centre  to
provide technical assistance to the Commission, and to undertake technical collaboration with
Member  States  and  the  WHO.  The  Centre  would  coordinate  laboratory  actions  with
microbiological  laboratory  networks.  The  Centre  would  be  a  source  of  information  for  all

6

partners; the information given must be timely, accurate, easily understandable by users and
adjusted to the different needs of the EU Institutions, Member States, public health institutes,
the media, the public. When the Commission is preparing policy proposals or draft legislation,
the Centre could provide authoritative scientific advice and technical input.

The Commission believes that an independent agency would be the best approach to enhance
cooperation  in  an  enlarged  European  Union.  Such  an  agency  -  the  European  Centre  for
Disease  Prevention  and  Control  -  would  focus  on  communicable  diseases,  where  there  is
already  extensive  experience  of  European  cooperation  and  other  emerging  serious  health
threats. It would facilitate collaboration by the Commission and the Member States with other
partners (e.g. third countries and international organisations, such as the WHO). This proposal
provides  for  an  appropriate  legal  base  and  a  dedicated  new  budget  line  in  the  Community
Budget.  The  role  of  the  Centre  in  this  Regulation  is  to  be  a  visible  centre  of  excellence  to
which the Commission and the Member States can go for authoritative advice and opinions.

In view of the scope and the mission of the Centre, there is also a need for coordination with
other  Community  agencies,  especially  the  European  Food  Safety  Authority  (EFSA)  and  the
European Agency for the Evaluation of Medicinal Products (EMEA), both of which also deal
with  health  assessments,  early  warning,  and  risk  communication.  There  must  be  a  clear
commitment to avoiding duplication of work between agencies.

5.

MAIN TASKS OF THE EUROPEAN CENTRE

Epidemiological surveillance and networking of laboratories

The Centre would develop epidemiological surveillance at European level.  In this work,  the
Centre could either use its own staff, staff from the dedicated surveillance networks (DSN),
or,  in  some  instances,  it  could  subcontract  tasks  to  a  national  centre  of  excellence.  This
gradual  integration  of  epidemiological  surveillance  will  lead  to  the  harmonisation  of
surveillance  methodologies,  including  better  comparability  and  compatibility  of  the
surveillance data collected in the Member States. The Centre could also identify and maintain
networks  of  reference  laboratories,  and  enhance  the  quality  assurance  schemes  of
microbiological laboratories.

To  maintain  high  standards  in  the  surveillance,  early  warning  and  response  network,  the
necessary staff  and technical resources  need to be  in  place  in  the Member  States  and  at  the
Community  level.  The  Centre  would  facilitate  the  training  of  expert  staff  and  provide
opportunities  for  them  to  gain  useful  ‘hands  on’  experience.  It  could  also  serve  as  a  place
where  the  Member  States  could  second  officials  from  national  institutes  to  work  a  limited
period as part of their career development.

There  is  already  considerable  experience  of  cooperation  between  Member  States’  public
health institutes on communicable diseases. Recognised procedures for cooperation, accepted
by  all,  already  exist.  It  therefore  makes  sense  for  the  Centre  to  focus  initially  on
communicable  diseases,  though  it  should  also  be  able  to  deal  with  other  emerging  health
threats  if  needed.  In  light  of  the  recently  adopted  “Communication  on  a  European
Environment and Health Strategy” (COM(2003)338 final) in which “health monitoring” is a
key element, the tasks of the Centre will be extended to cover “health monitoring” as soon as
feasible.

Scientific opinions

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Public health decisions have to be based on independent scientific evidence. The Centre will
support the Commission and Member States by providing this. The Centre would contribute
to public health policies by providing scientific assessments and technical support, based on
scientific  excellence,  and  maintained  through  its  own  expertise  and  that  existing  in  the
Member  States.  If  there  is  insufficient  scientific  expertise  in  the  Centre,  or  in  the  disease
surveillance  networks,  the  Director  may,  in  consultation  with  the  Advisory  Forum,  set  up
independent scientific panels for this purpose drawn from recognised scientific authorities and
academia.

Scientific  issues  arising  in  the  area  of  communicable  diseases  vary  widely,  ranging  from
questions  of  clinical  medicine  and  epidemiology  through  to  standardisation  of  laboratory
procedures. Creating one permanent scientific committee to cover all these issues would not,
therefore,  be  appropriate.  The  Centre  would,  instead,  bring  together  scientific  expertise  in
specific fields through its various EU-wide networks and via ad hoc scientific panels.

The  Advisory  Forum,  consisting  of  scientists  from  public  health  institutes  in  the  Member
States, would support  the  Director  in  ensuring  excellence  and  independence  of  the  Centre’s
scientific  work.  The  Centre  would  issue  scientific  opinions  in  accordance  with  procedures
defined in the Regulation.

Information made available through EU funded research projects and other EU agencies, such
as  European  Food  Safety  Authority  (EFSA)  and  European  Agency  for  Evaluation  of
Medicinal  Products  (EMEA)  would  have  to  be  used  by  the  Centre  where  appropriate.  Its
scientific panels would not be allowed to duplicate work done elsewhere. The Centre should
initiate applied scientific studies to enhance policy  development  and also  studies to develop
and enhance its own operation effectiveness. To avoid duplication, the Centre will co-ordinate
its actions with those of the Member States and the EU Framework Programme on Research.

Early Warning and Response

To be effective  the  early warning and  response system (EWRS)  requires  ‘around the clock’
availability of specialists in communicable diseases. Whilst the responsibility for action will
remain with Member States and the Commission, technical operation of the EWRS would be
undertaken by the Centre and its networks.

The  Centre  would  coordinate,  as  appropriate,  with  relevant  EU  agencies,  such  as  the
European Food Safety Authority, and with other alert systems, such as those run by the WHO.
Response  is  a  key  element  in  preparedness  and  control  of  outbreaks.  Rapid  reaction  can
ensure  a  disease  outbreak  is  limited  and  prevent  its  deteriorating  into  a  wider  crisis.  The
Centre will be a source of assistance and advice to the Commission and the Member States in
managing these risks.

Technical Assistance

The  Centre's  rapid  reaction  capacity  could  cover  more  than  the  European  Union  itself,  to
similar structures in such areas as the EEA/EFTA, and candidate countries. When requested,
it  would  send  an  EU-team  to  investigate  an  outbreak  of  an  unknown  human  disease  in  a
European  country.  The  Centre  should  also  have  the  ability  to  support,  if  necessary  those
Commission  services  that  give  humanitarian  aid  or  other  types  of  assistance  in  response  to
disease outbreaks in third countries. In these situations, the technical assistance should be co-
ordinated  with  the  appropriate  Commission  services,  and  relevant  EU  programmes.  The
Centre  would  have  a  particular  role  in  defining  action  in  those  states  that  might  import  the

8

disease. In the  case of an  outbreak  investigation mission,  depending on the identification of
the  source  of  the  outbreak  (environmental,  food,  animal,  chemical,  deliberate  release  etc.)
other appropriate EU agencies, and the WHO may have to be involved, in order to strengthen
the coherence of the combined efforts avoid duplicating activities.

Emergencies and Communication

The Centre should have a major role in coordinating the response to serious health threats of
EU-wide significance. The need for co-ordinated action is of pivotal importance, taking into
account  all  the  actors  involved  in  emergencies.  For  example,  public  health  authorities,  civil
protection,  the  military  and  civil  society  may  all  need  to  be  involved  in  responding  to  an
epidemic.  A  combined  effort  of  these  different  instruments  as  part  of  a  comprehensive  EU
policy,  will  be  required  in  such  emergencies.  The  creation  of  the  Centre  constitutes  an
important  contribution  to  this  effort.  Considering  the  relatively  small  size  of  the  Centre,
however, it will only be able to take on such a coordinating role where the health threat is of
direct relevance to its operational goals.

Objective, reliable and easily accessible information is essential for the general public and as
well  as  for  decision-makers  in  the  Commission,  Member  States,  and  international
organisations. The Centre will communicate  about its activities  and  results, and  disseminate
information  tailored  to  meet  the  needs  of  its  different  audiences.  Using  various  media  and
communications tools, the Centre will ensure that its information is easily accessible, reliable,
and understandable.

6.

THE EUROPEAN CENTRE SHOULD BE SMALL BUT INFLUENTIAL

The  Centre  would  remain  small  in  terms  of  human  resources,  but  possessing  a  far  larger
influence  through  its  synergy  with  national  institutes.  The  staff  will  include  relevant
specialists,  such  as  epidemiologists,  public  health  experts,  microbiologists,  logisticians  and
medical writers, as well as administrators.

The  Centre  will  be  funded  from  the  Community  budget,  based  on  a  proposal  from  the
Commission and approved by the Budgetary Authority.

Within  this  budget,  in  addition  to  its  normal  running  costs,  the  Centre  should  have  an
appropriate  contingency  budget  to  enable  it  to  respond  speedily  and  adequately  to  public
health threats, when needed. The contingency budget must be sufficient to cover the breadth
of operations which might be called for in such diverse settings as outbreak investigations, in
the  European  Union  or  elsewhere,  deliberate  release  of  biological  agents,  or  controlling  a
potential  influenza  pandemic.  The  Centre  should  also  have  a  consultative  role  in  providing
scientific advice in crises, such as in an influenza pandemic, where public health is involved.

7.

THE ADMINISTRATIVE STRUCTURE

As  with  other  similar  independent  Community  agencies,  the  Centre  will  have  a  three  pillar
administrative structure:

– 

A  Director  and  his/her  staff.  The  Director  will  be  responsible  for  everyday
administration,  as  well  as  the  preparation  and  implementation  of  the  Centre's
work programme.

9

– 

– 

A Management Board will ensure that the Centre carries out its  missions and
tasks,  by  adopting  its  annual  work  programme  and  financial  regulation.  The
structure  of  the  Management  Board  –  representatives  appointed  by  the
Commission, representatives appointed by the Council, and representatives of
stakeholders – is intended to provide supervision of the activities of the Centre
and at the same time ensure coherence with action under Community policies
and national initiatives.

An Advisory Forum, which will be composed of members chosen from senior
scientific personnel from the national competent bodies. The Advisory  Forum
will  be  a  mechanism  for  exchanging  information  and  pooling  knowledge,  as
well as monitoring the scientific excellence of the activities of the Centre.

8.

MAKING THE TRANSITION FROM THE CURRENT STRUCTURE

There is a budget in place from the Public Health Action Programme to carry out some of the
preparatory work to set up the Centre. Until 2006, external expertise can be used to prepare
the  integration  of  the  existing  Dedicated  Surveillance  Networks  into  the  Centre.  Projects
dealing with capacity building, dissemination of information and training might be candidates
for early integration into the new structure.

It  is  also  important  for  relevant  laboratories  to  become  involved  in  European  level
surveillance  activities.  The  Commission  will  enhance  the  development  of  laboratory
networks, including those European laboratories with the capacity to handle highly contagious
micro-organisms, like smallpox virus. It will maintain and update the support databases  and
develop  the  Early  Warning  and  Response  system  (EWRS)  further.  The  procedures  for
effective exchange of information will also be developed.

Before  the  Centre  becomes  operational  the  Commission  will  concentrate  on  making  the
intervention teams, currently set up on a national basis in an ad hoc manner, more effective.
This will be done in collaboration with the Member States taking  account the  Commissions
existing actions in third countries in particular in liaison with the WHO. Running high quality
surveillance,  early  warning,  and  response  is  not  possible  without  trained  specialists,  with  a
variety of expertise at national and EU level.

The Task Force on deliberate release of chemicals and biological agents (BICHAT) was set
up by the Commission in 2002 to identify the special needs in surveillance and response that
might  be  necessary  should  a  terrorist  attack  be  envisaged.  The  Task  Force  comprises  a
number of seconded national experts from the Member States over a limited time period and
it  reports  through  the  Health  Security  Committee  of  personal  representatives  from  the
Ministers of Health of the Member States. Eventually the work of the Task Force will need to
be taken over by the Centre.

9.

CONCLUSION

The  dangers  posed  by  communicable  diseases  do  not  diminish.  Multiresistant  tuberculosis,
HIV/AIDS  and  more  recently  SARS  remind  the  European  Union  to  be  on  its  guard.
Enlargement  reinforces  the  need  to  put  in  place  adequate  EU-level  capacity,  building  on
Member States' systems and the existing Communicable Disease Network, to respond to such
health  threats.  The  creation  of  a  European  Centre  for  Disease  Prevention  and  Control  will
ensure efficient networking and pooling of Member  States'  scientific  expertise  and facilitate

10

more  effective  preparedness  planning.  By  doing  this,  the  Centre  will  strengthen  the  EU
capacity to react to future health threats.

11

2003/0174 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

Establishing a European Centre [for Disease Prevention and Control]

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article
152 paragraph 4 thereof,

Having regard to the Agreement on the European Economic Area,

Having regard to the proposal from the Commission1,

Having regard to the opinion of the European Economic and Social Committee2,

Having regard to the opinion of the Committee of the Regions3,

Acting in accordance with the procedure laid down in Article 251 of the Treaty4,

Whereas:

(1)

(2)

(3)

1

2

3

4

5

The Community is committed as a priority to protect, and to improve human health by
prevention  of  human  disease,  in  particular  communicable  diseases  and  to  counter
potential threats to health with a view to ensuring a high level of protection of health,
requiring  a  coherent  approach  among  Member  States,  coordinated  at  Community
level.

The  Community  should  address  European  citizens’  concerns  about  public  health
threats  in  a  coordinated  and  coherent  way.  As  the  protection  of  health  can  mean
various  actions  from  preparedness  and  control  measures  to  prevention  of  human
diseases, the scope of actions should be kept broad.

Member  States  must  provide  information  on  communicable  diseases  through  the
appropriate designated structures and/or authorities, according to Article 4 of Decision
No  2119/1998/EC5,  which  requires  timely  scientific  analysis  in  order  for  effective
Community action to be undertaken.

OJ C , , p. .
OJ C , , p. .
OJ C , , p. .
OJ C , , p. .
OJ L268, 3.10.1998, p.1

12

                                                
(4)

(5)

(6)

(7)

(8)

(9)

(10)

(11)

(12)

Decision  No  2119/1998/EC  expressly  calls  for  the  improvement  of  the  coverage  and
effectiveness  of  existing  designated  networks  between  Member  States  for  the
surveillance  of  communicable diseases  on which Community  actions should  be  built
and the need to foster cooperation with third countries and international organisations,
in particular the World Health Organisation.

Effective  response  to  disease  outbreaks  with  potential  effects  on  the  health  of
European citizens requires coordination of Member States’ contribution and input by
experienced scientists at Community level. The danger of deliberate release of agents
also requires a coherent Community response to such criminal threats.

An  independent  agency,  hereinafter  named  the  European  Centre  [for  Disease
Prevention and Control] should serve as a Community source of independent scientific
advice, assistance, and expertise from trained medical, scientific, and epidemiological
staff  from  its  own  resources  or  from  those  of  competent  bodies  acting  on  behalf  of
Member States’ authorities responsible for human health.

The  Centre  should,  in  particular,  be  able  to  assign  certain  tasks  to  recognised
competent bodies in the Member States. Cooperation with other relevant EU agencies
and institutions should be encouraged to avoid duplication of activities.

The Centre’s mission should contribute to enhance epidemiological surveillance, rapid
reaction  and  response  to  communicable  diseases  and  other  serious  health  threats,  to
promote  training, to improve  reliable  communication, and to advise on public  health
policy,  when  requested.  Therefore,  the  Centre  should  complement  existing  activities
with regard to health monitoring, epidemiological surveillance, training programmes,
and early warning and response mechanisms.

The Centre should gather and analyse data and information on emerging public health
threats  and  developments  for  the  purpose  of  protection  of  public  health  in  the
European  Community  by  preparedness.  It  shall  assist  and  coordinate  with  Member
States in developing and maintaining the capacity to  react in a timely way. In public
health emergencies the Centre should operate in close collaboration with Commission
services and other agencies, Member States, and international organisations.

The Centre should seek to maintain scientific excellence at all times through its own
expertise and the expertise in the Member States and foster, develop and steer applied
scientific  studies.  By  this  way,  it  will  enhance  the  visibility  and  credibility  of  the
scientific expertise in the European Community. Moreover, it will support Community
preparedness  planning,  strengthening  links  with  and  between  the  clinical  and  public
health  sectors,  in  order  to  reinforce  the  public  health  laboratory  capacity  for  rapid
diagnosis,  developing  training  programs  for  healthcare  providers,  and  developing
educational materials.

The  Management  Board  should  be  appointed  in  such  a  way  as  to  secure  the  highest
standard  of  competence  in  public  administration  and  in  the  areas  of  actions  of  the
Centre.

The  Management  Board  should  have  the  necessary  powers  to  establish  the  budget,
check its implementation, draw up internal rules, to ensure coherence with Community
policies, to adopt financial regulations, and appoint the Director.

13

(13) An Advisory Forum shall advise the Director in the performance of his/her duties. It
shall be composed of representatives of competent bodies in the Member States, which
undertake  tasks  similar  to  those  of  the  Centre.  The  Advisory  Forum  constitutes  a
mechanism  for  an  exchange  of  information  on  potential  risks  and  the  pooling  of
knowledge and for monitoring scientific excellence and independence of the Centre’s
work.

(14)

(15)

(16)

(17)

(18)

The  confidence  of  the  Community  institutions,  the  general  public  and  interested
parties in the Centre is essential. For this reason, it is vital to ensure its independence,
high scientific quality, transparency and efficiency.

The  independence  of  the  Centre  and  its  role  in  informing  the  public  mean  that  it
should  be  able  to  communicate  autonomously  in  the  fields  falling  within  its
competence, its purpose being to provide objective, reliable and easily understandable
information to improve citizens’ confidence.

The  Centre  should  be  financed  by  the  general  budget  of  the  European  Union.  The
Community budgetary procedure remains applicable as far as any subsidies chargeable
to  the  general  budget  of  the  European  Union  are  concerned.  Moreover,  the  Court  of
Auditors should undertake the auditing of accounts.

It  is  necessary  to  allow  for  the  participation  of  European  countries  which  are  not
members of the European Union and which have concluded agreements obliging them
to transpose and implement the body  of  Community  law  in  the  field  covered  by  this
Regulation.

The  Centre  should  also  be  able  to  initiate  scientific  studies  necessary  for  the
accomplishment of  its duties, while ensuring that the links established by  it  with  the
Commission and the Member States will avoid duplication of effort. It should be done
in  an  open  and  transparent  fashion  and  the  Centre  should  take  into  account
Community expertise, structures, and agencies already in place.

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SCOPE AND RESPONSIBILITIES

Article 1

1.

2.

This  regulation  establishes  an  independent  European  agency  for  disease  prevention
and control, its mission and tasks, and its organisation.

The Agency shall be named the European Centre for Disease Prevention and Control,
hereinafter referred to as the ‘Centre’.

Article 2

Definitions

14

For the purposes of this Regulation:

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

‘Competent body’ shall mean any structure, institute, agent or other  scientific
body  recognised  by  Member  States’  authorities  as  providing  independent
scientific advice or capacity for action in the field of prevention and control of
human disease.

‘Prevention and  control  of  human  disease’  shall  mean  the  range  of  measures
taken  by  the  competent  public  health  authorities  in  the  Member  States  to
prevent and stop the spread of the disease.

‘Dedicated surveillance network’ shall mean any specific network on diseases
or  special  health  issues  selected  for  epidemiological  surveillance  between
accredited structures and authorities of the Member States.

‘Health threat’ shall mean a condition, agent or incident, which causes, directly
or indirectly, ill health.

‘Epidemiological  surveillance’  shall  have  the  meaning  ascribed  to  it  in
Decision No 2119/1998/EC.

‘Community  network’  shall  have  the  meaning  ascribed  to  it  in  Decision  No
2119/1998/EC.

‘Early warning and  response system’  shall  mean  the  network  under  Decision
(EC) No 2119/1998 for the prevention and control of  communicable  diseases,
formed  by  bringing  into  permanent  communication  with  one  another  through
in  Commission  Decision  N°  57/2000EC
appropriate  means  specified 
implementing Decision No 2119/1998/EC.

Article 3

Mission of the Centre

1.

The  mission  of  the  Centre  is  to  analyse  and  assess  risks  to  human  health  from
communicable  diseases  and  other  serious  health  threats  affecting  the  European
Community, to provide expert advice to the Commission and the Member States, and
to enhance the capacity of the European Community and its Member States to protect
human  health  through  prevention  and  control  measures  on  communicable  diseases
and  other  serious  health  threats.  The  scope  of  the  Centre  will  be  extended  (from
communicable  diseases  and  emerging  health  threats)  to  cover  health  monitoring  as
soon as feasible.

2.

The primary objective of the Centre shall be to cooperate with the Member States in
order to achieve coherent, timely, and effective actions by:

– 

Promoting the European networking of bodies operating in the fields within the
Centre’s  mission,  including  the  use  and  encouragement  of  networks  arising
from public health activities supported by the Commission;

15

– 

– 

Facilitating  the  coordination  of  networking  activities,  the  exchange  of
information,  the  development  and  implementation  of  joint  projects,  the
exchange of expertise and best practises;

Searching  for,  collecting,  collating,  analysing  and  summarising  relevant
scientific and technical data in the fields of its mission.

3.

4.

In  pursuing  its  mission  the  Centre  shall  take  full  account  of  the  responsibilities
attributed by Community legislation to the Commission, the Member States, and to
other Community agencies, and the responsibilities of international organisations, in
order to ensure comprehensiveness, coherence, and complementarity of action.

The Centre, Commission and Member States shall cooperate to promote the effective
coherence  between  risk  assessment,  risk  management  and  risk  communication
functions within the framework of its mission.

Article 4

Responsibilities of the Member States

To ensure the accomplishment of the Centre’s mission the Member States shall co-operate by:

– 

– 

– 

– 

Providing  to  the  Centre  all  the  scientific  and  technical  data  and  information
needed  to  address  health  threats  and  developments  at  the  Community  level.
Member  States  shall  take  the  necessary  measures  to  ensure  that  information
and data they collect are transmitted expeditiously to the Centre;

Communicating  to  the  Centre  any  messages  forwarded  to  the  Community
network via the Early Warning and Response System;

Identifying  recognised  competent  bodies,  within  the  field  of  operation  of  the
mission of the Centre, which could be made available to assist in Community
responses to health threats.

Seconding to the Centre public health officers, including epidemiologists, for a
defined period of time, for achievement of certain tasks of the Centre, such as
field investigations in case of disease clusters or outbreaks.

CHAPTER 2

TASKS OF THE CENTRE

Article 5

Networking of organisations operating in the fields within the Centre’s mission

1.

The  Centre,  through  the  provision  of  technical  and  scientific  expertise  to  the
Commission  and  Member  States,  shall  support  the  networking  activities  and

16

dedicated  surveillance  networks  of  authorities  and  structures  designated  under
Decision (EC) No 2119/1998, and to ensure their integrated operation.

2.

The Centre shall

– 

Provide quality assurance by monitoring and evaluating surveillance activities
of such dedicated surveillance networks to ensure optimal operation;

–  Maintain the database(s) for such epidemiological surveillance, and

– 

Communicate the results of the analysis of data to the Community Network.

The  Centre  may  delegate  parts  or  all  of  these  tasks  to  one  of  the  dedicated
surveillance networks.

By  enhancing  cooperation  between  expert  laboratories  the  Centre  shall  foster  the
development  of  sufficient  capacity  at  the  Community  level  for  microbiological
diagnostics to detect micro-organisms in routine and exceptional circumstances. The
Centre shall maintain and extend such cooperation and enhance the implementation
of quality assurance schemes.

The  Centre  shall  work  with  the  assistance  of  competent  bodies  recognised  by  the
Member  States.  The  Centre  may  entrust  to  one  or  more  of  these  competent  bodies
certain  tasks,  particularly  preparatory  work  for  scientific  opinions,  scientific  and
technical assistance, collection of data and identification of emerging risks, in order
to provide control of public health threats.

Article 6

Scientific support and training

The  Centre  shall  provide  support  to  the  Commission  and  the  Member  States  with
independent scientific assessments and technical support, notably from the dedicated
surveillance  networks,  together  with  information  on  specific  issues  from  other
authoritative  scientific  sources,  including  results  from  Community  funded  research
and  public  health  projects.  In  carrying  out  this  task  the  Centre  will  consult  with
Commission  where  the  planning  and  priority  setting  of  research  and  public  health
activities are concerned.

Where such independent scientific expertise is not available from existing dedicated
surveillance networks the Centre may set up independent ad hoc scientific panels.

The  Centre  may  initiate  scientific  studies  necessary  for  the  performance  of  its
mission.  The  Centre  shall  avoid  duplication  with  Member  States’  or  Community
research programmes by providing advice and direction on important priority issues.

The Centre shall seek to maintain scientific excellence at all times through the best
expertise  available,  and  initiate  applied  scientific  studies  and  projects  on  the
feasibility, development and preparation of its activities.

The  Centre  shall  support  and  co-ordinate  training  programmes  in  order  to  assist
Member States and the Community to have sufficient numbers of trained specialists,

17

3.

4.

1.

2.

3.

4.

5.

in particular on epidemiological surveillance  and field investigations, and to have a
capability to define public health measures to control disease outbreaks.

Article 7

Procedure for scientific opinions

1.

The Centre shall issue a scientific opinion:

– 

At the request of the Commission, in respect of any matter within its mission,
and in all cases where Community legislation makes provision for the Centre to
be consulted;

– 

On its own initiative, on matters falling within its mission.

The  European  Parliament  or  a  Member  State  may  request  the  Centre  to  issue  a
scientific opinion on matters falling within its mission.

Requests referred to in paragraph 1 shall be accompanied by background information
explaining the scientific issue to be addressed and the Community interest.

The  Centre  shall  issue  scientific  opinions  within  the  time  limit  specified  in  the
requests for opinions, except in duly justified circumstances.

Where different requests are made on the same issues or where the request is not in
accordance with paragraph 2, or is unclear, the Centre may either refuse, or propose
amendments  to  a  request  for  an  opinion  in  consultation  with  the  institution  or
Member State(s) that made the request. Justifications for the refusal shall be given to
the institution or Member States(s) that made the request.

Where the Centre has already delivered a scientific opinion on the specific topic in a
request,  it  may  refuse  the  request  if  it  concludes  there  are  no  scientific  elements
justifying  the  re-examination.  Justifications  for  the  refusal  shall  be  given  to  the
institution or Member State(s) that made the request.

The  Centre’s  internal  rules  shall  specify  requirements  in  regard  to  format,
explanatory background and publication of a scientific opinion.

Article 8

Operation of early warning and response

The  Centre  shall  support the Community network of designated  authorities  and  the
Commission  under  Decision  No  2119/1998/EC  by  providing  assistance  to  the
Commission.  The  Centre  shall  operate  the  Early  Warning  and  Response  System
(EWRS)  provided  for  therein  and  ensure  at  all  times  capacity  for  co-ordinated
European responses to public health threats under this framework.

The Centre  shall  analyse  the content  of  messages  forwarded  to  Member  States  and
the  Commission  via  the  Early  Warning  and  Response  System  as  laid  down  in
Decision  No  57/2000/EC  and  sent  to  it.  The  Centre  shall  provide  information,

18

2.

3.

4.

5.

6.

1.

2.

expertise,  advice  and  analysis  on  risk  assessment  for  the  purposes  of  risk
management  by  the  Commission  and  the  Member  States.  The  Centre  shall  ensure
that  such  actions  on  this  Early  Warning  and  Response  System  are  efficiently  and
effectively  co-ordinated  and  integrated  into  other  Community  alert  systems  (e.g.
animal health, food and feed, and civil protection).

Article 9

Procedure for technical assistance

The  Centre  may  be  requested  by  the  Commission  to  provide  scientific  or  technical
assistance  in  any  field  within  its  mission.  The  tasks  of  providing  scientific  and
technical  assistance  shall  consist  of  scientific  or  technical  work  involving  the
application  of  well-established  scientific  or  technical  principles.  Such  tasks  may
include in particular assistance to the Commission for the establishment or evaluation
of  criteria  and  also  assistance  to  the  Commission  in  the  development  of  technical
guidelines.

Where  the  Commission  refers  a  request  for  scientific  or  technical  assistance  to  the
Centre, it shall specify, in agreement with the Centre, the time limit within which the
task must be completed

In the case of a disease outbreak or human health crisis for which a Member State a
third  country  or  an  international  organisation  requests  assistance,  the  Centre,  after
consulting  the  Commission  to  ensure  coherence  with  Community  policies,  may
respond  within  its  financial  capacity  and  mandate.  Such  assistance  could  include
mobilising  and  co-ordinating  investigation  teams,  providing  expert  assistance,  or
other actions to resolve the crisis.

In the case of such a request for assistance from a Member State, a third country or
international organisation, where the financial capacity of the Centre is not adequate
to deal with that request, the Centre shall assess the request and obtain agreement of
the  Commission  on  its  possibilities  for  response  directly  or  through  other
Community mechanisms.

The  Centre  shall  inform  Member  States  authorities  and  the  Commission  without
delay  within  the  framework  of  the  Community  Network  set  up  by  Decision  No
2119/1998/EC of any such request.

Article 10

Identification of emerging public health threats and preparedness

The  Centre  shall  establish  surveillance  procedures  for  systematically  searching  for,
collecting,  collating  and  analysing  information  and  data  with  a  view  to  the
identification of emerging public health threats to the European Community.

Where  the  Centre  has  information  leading  it  to  suspect  an  emerging  public  health
threat,  it  can  request  additional  information  from  the  Member  States,  other
Community  agencies  and  the  Commission.  The  Member  States,  the  Community
agencies concerned and the Commission shall reply as a matter of urgency.

19

1.

2.

3.

4.

5.

1.

2.

3.

4.

5.

1.

2.

3.

1.

2.

3.

4.

The  Centre  shall  annually  forward  the  evaluation  and  information  collected  on
emerging  threats  and  risks  to  the  Commission,  the  European  Parliament,  and  the
Council.

The  Centre  shall  provide  scientific  and  technical  expertise  to  the  Commission,
Community bodies, and the Member States in the development of preparedness plans
for  pandemic  situations  or  outbreaks  caused  deliberately  or  otherwise,  and  in  their
regular review and updating.

The  Centre  shall  support  the  Commission,  Community  bodies,  and  the  Member
States  in  developing  intervention  strategies,  such  as  immunisation,  by  providing
scientific opinions, expert advice, data, and information.

Article 11

Collection and analysis of data

The  Centre  shall  carry  out  coordination  of  data  collection,  validation,  analysis  and
dissemination  of  data  at  Community  level.  The  statistical  element  of  this  data
collection  will  be  developed  in  collaboration  with  Member  States  using,  as
necessary,  the  Community  Statistical  Programme,  to  promote  synergy  and  avoid
duplication.

For the purposes of paragraph 1, the Centre shall work in close cooperation with the
competent bodies of the Member States, organisations operating in the field of data
collection,  from  the  European  Community,  third  countries,  the  World  Health
Organisation (WHO), and other international organisations.

The  Centre  shall  make  available  relevant  information  collected  as  referred  in
paragraphs 1 and 2 to the public in an objective, reliable and easily accessible way.

Article 12

Communications from the Centre

The Centre shall communicate on its own initiative in the fields within its mission. It
shall  ensure  that  the  public  and  any  interested  parties  are  rapidly  given  objective,
reliable and  easily accessible information, in particular with regard to the results of
its  work.  In  order  to  achieve  these  objectives,  the  Centre  shall  develop  and
disseminate information material for the general public.

The  Centre  shall  act  in  close  collaboration  with  the  Commission  and  the  Member
States to promote the necessary coherence in the risk communication process. It shall
publish its advice in accordance with Article 20.

The  Centre  shall  ensure  appropriate  cooperation  with  the  competent  bodies  in  the
Member  States  and  other  interested  parties  with  regard  to  public  information
campaigns.

The Centre shall assist the Commission and the Member States in the preparation of
guidelines  on  good practice,  and  on  protective  measures  to  be  taken  in  response  to

20

human  health  threats  in  particular  in  support  of  actions  undertaken  under  the
Community network.

CHAPTER 3

ORGANISATION

Article 13

Bodies of the Centre

The Centre shall comprise:

(a)  A Management Board;

(b)  A Director and his/her staff;

(c)  An Advisory Forum.

Article 14

Management Board

1.

2.

The Management Board shall be composed of 15 members, six of them representing,
and  appointed  by  the  Commission,  six  by  the  Council,  representing  national
executives,  and  three  members  nominated  by  the  Commission,  representing
interested  parties  at  European  level,  such  as  non-governmental  organisations
representing patients, professional bodies, or academia.

The members of the Board shall be appointed in such a way as to secure the highest
standards  of  competence,  a  broad  range  of  relevant  expertise  and,  consistent  with
these, the broadest possible geographic distribution within the Union.

Alternates who will represent the member  in  his/her  absence  shall  be  appointed  by
the same procedure.

Members' term  of  office  shall  be  four  years,  and  may  be  extended  once.  However,
for the first mandate, this period shall be six years for half of the members.

3.

The  Management  Board  shall  adopt  the  Centre's  internal  rules  on  the  basis  of  a
proposal by the Director. These rules shall be made public.

The  Management  Board  shall  elect  one  of  its  members  as  its  Chair  for  a  two-year
period, which shall be extendable.

The Management Board shall meet at least twice a year at the invitation of the Chair,
or at the request of at least a third of its members.

4.

The Management Board shall:

21

– 

– 

– 

– 

– 

Exercise  disciplinary  authority  over  the  Director  and  appoint  or  dismiss
him/her pursuant to Article 17.

Ensure that the Centre carries out its mission and performs the tasks assigned
to it under the conditions laid down in this Regulation.

Draw  up  a  list,  on  the  proposal  from  the  Director,  to  be  made  public  of
competent bodies referred to in Article 5(4).

Adopt,  before  31  January  each  year,  the  Centre's  programme  of  work  for  the
coming  year.  It  shall  also  adopt  a  revisable  multi-annual  programme.  The
Management Board shall ensure that these programmes are consistent with the
Community's legislative and policy priorities in the area of its mission. Before
30 March each year, the Management Board shall adopt the general report on
the Centre's activities for the previous year.

Adopt  the  financial  rules  applicable  to  the  Centre  after  the  Commission  has
been  consulted.  They  may  not  depart  from  Commission  Regulation  (EC,
Euratom)  No  2343/2002  of  23December  2002  on 
framework
Financial Regulation  for  the  bodies  referred  to  in  Article 185  of  Council
Regulation 
the  Financial  Regulation
applicable  to  the  general  budget  of  the  European  Communities  unless
specifically required for the Centre's operation and with the Commission's prior
consent.

(EC, Euratom)  No 1605/2002  on 

the 

5.

1.

2.

3.

4.

The  Director  shall  take  part  in  the  meetings  of  the  Management  Board,  without
voting rights, and shall provide the Secretariat.

Article 15

Voting

The Management Board shall take its decisions by a simple majority of all members,
without prejudice to Article 17.

Each of these members shall have one vote. The Director of the Centre shall not vote.

In the absence of a member, his/her alternate shall be entitled to exercise his/her right
to vote.

The  rules  of  procedure  shall  establish  the  more  detailed  voting  arrangements,  in
particular, the conditions for a member to act on behalf of another member.

22

Article 16

Director

1.

2.

The Centre shall be managed by its Director, who shall be completely independent in
the  performance in his/her  duties,  without  prejudice  to  the  respective  competencies
of the Commission and the Management Board.

The Director shall be the legal representative of the Centre and shall be responsible
for:

(a)  The day-to-day administration of the Centre;

(b)  Drawing up a draft work programmes in consultation with the Commission;

(c)  Preparation of discussions within the Management Board;

(d) 

Implementing  the  work  programmes  and  the  decisions  adopted  by  the
Management Board;

(e)  Ensuring  the  provision  of  appropriate  scientific,  technical  and  administrative

support for the Advisory Forum;

(f)  Ensuring  that  the  Centre  carries  out  its  tasks  in  accordance  with  the
requirements of its users, in particular with regard to the  scientific  excellence
and  independence  of  activities  and  opinions,  the  adequacy  of  the  services
provided and the time taken;

(g)  The preparation of the statement of revenue and expenditure and the execution

of the budget of the Centre;

(h)  All staff matters, and in particular the exercise of powers laid down in Article

29(2).

3.

Each year, the Director shall submit to the Management Board for approval:

(a)  A draft general report covering all the activities of the Centre  in  the  previous

year;

(b)  Draft programmes of work;

(c)  The draft annual accounts for the previous year;

(d)  The draft budget for the becoming year.

4.

The Director shall, following adoption by the Management Board, by 15 June at the
latest forward the annual report on the Centre's activities to the European Parliament,
the  Council,  the  Commission,  the  Court  of  Auditors,  the  European  Economic  and
Social  Committee  and  the  Committee  of  the  Regions.  The  Centre  shall  forward
annually  to  the  budgetary  authority  any  information  relevant  to  the  outcome  of  the
evaluation procedures.

23

5.

The Director shall report on the Centre's activities to the Management Board.

1.

2.

3.

1.

2.

3.

4.

Article 17

Appointment of the Director

The Director shall be appointed by the Management Board on the basis  of  a  list of
candidates  proposed  by  the  Commission  after  an  open  competition,  following
publication in the Official Journal of the European Union and elsewhere of a call for
expressions of interest, for a period of five years, which may be extended once for a
further period of up to five years.

The  Management  Board  shall  take  its  decision  by  a  two-thirds  majority  of  all
members.  Power  to  dismiss  the  Director  shall  lie  with  the  Management  Board,
according to the similar procedure.

Before  appointment  the  candidate  nominated  by  the  Management  Board  shall  be
invited  without  delay  to  make  a  statement  before  the  European  Parliament  and
answer questions put by members of this institution.

Article 18

Advisory Forum

The  Advisory  Forum  shall  be  composed  of  members  from  technically  competent
bodies in the Member States which undertake tasks similar to those of the Centre, on
the  basis  of  one  representative  designated  by  each  Member  State  recognised  for
his/her  scientific  competence.  Representatives  may  be  replaced  by  alternates,
appointed at the same time.

Members of the Advisory Forum may not be members of the Management Board.

The Advisory Forum shall support the Director in ensuring the scientific excellence
and independence of activities and opinions of the Centre.

The Advisory Forum shall constitute a mechanism for an exchange of information on
potential  risks  and  the  pooling  of  knowledge.  It  shall  ensure  close  cooperation
between the Centre and the competent bodies in the Member States in particular on
the following items:

(a) Coherence of the Centre’s scientific studies with Member States;

(b)

(c)

In those circumstances where the Centre and a national body are obliged to co-
operate;

In the promoting, starting  up,  and supervising of the European networking of
organisations operating within the fields of the Centre’s mission;

(d) Where the Centre or a Member State identifies an emerging public health risk;

(e)

The setting up of scientific panels by the Centre;

24

5.

6.

7.

1.

2.

3.

1.

6

(f)

Identifying  possible  scientific  and  public  health  priorities  for  the  work
programme.

The Director shall chair the Advisory Forum. It shall meet regularly at the invitation
of the Chair, or at the request of at least a third of its members, and not less than four
times per  year.  Its operational procedures shall  be specified  in  the  Centre's  internal
rules and shall be made public.

The  Centre  shall  provide  the  technical  and  logistic  support  necessary  for  the
Advisory Forum and provide the Secretariat for its meetings.

Representatives of the Commission's departments may participate in the work of the
Advisory  Forum.  The  Director  may  invite  experts  or  representatives  from  other
relevant bodies to take part.

CHAPTER 4

TRANSPARENCY AND CONFIDENTIALITY

Article 19

Declaration of Interest

The  members  of  the  Management  Board,  the  members  of  the  Advisory  Forum,
scientific panels, and the Director shall undertake to act in the public interest.

The  Director,  the  members  of  the  Advisory  Forum,  as  well  as  external  experts
participating  in  scientific  panels  shall  make  a  declaration  of  commitment  and  a
declaration of interests indicating either the absence of any interests which might be
considered prejudicial to their independence or any direct or indirect interests which
might  be  considered  prejudicial  to  their  independence.  Those  declarations  shall  be
made annually in writing.

The  Director,  the  members  of  the  Advisory  Forum,  as  well  as  external  experts
participating  in  scientific  panels  shall  declare  at  each  meeting  any  interests  which
might be considered prejudicial to their independence in relation to the items on the
agenda.  In  such  cases  these  persons  have  to  disqualify  themselves  from  relevant
discussions and decisions.

Article 20

Transparency and protection of information

Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30
May 2001 regarding public access to European Parliament, Council and Commission
documents 6, shall apply to documents held by the Centre.

OJ L 145, 31.5.2001, p. 43.

25

                                                
2.

3.

4.

1.

2.

3.

4.

1.

The  Management  Board  shall  adopt  the  practical  arrangements  for  implementing
Regulation (EC) No 1049/2001 within six months of entry into  force  of  the present
Regulation.

Decisions taken by the Centre pursuant to Article 8 of Regulation (EC) No 1049/2001
may give rise to the lodging of a complaint to the Ombudsman or form the subject of
an  action  before  the  Court  of  Justice  of  the  European  Communities,  under  the
conditions laid down in Articles 195 and 230 of the Treaty respectively.

The information collected in accordance with this Regulation by the Commission and
the  Centre,  shall  be  subject  to  Regulation  (EC)  N°  45/2001  of  the  European
Parliament and of the Council of 18 December 2000 on the protection of individuals
with  regard  to  the  processing  of  personal  data  by  the  Community  institutions  and
bodies and on the free movement of such data7.

Article 21

Confidentiality

By  way of  derogation from  Article 20,  the Centre  shall  not  divulge  to  third  parties
confidential  information  that  it  receives  for  which  confidential  treatment  has  been
requested  and  justified,  except  for  information,  which  must  be  made  public  if
circumstances so require, in order to protect public health.

Members  of  the  Management  Board,  the  Director,  as  well  as  external  experts
participating in the scientific panels, members of the Advisory Forum, and members
of the staff of the Centre, even after their duties have ceased, shall be subject to the
requirements of confidentiality pursuant to Article 287 of the Treaty.

The  conclusions  of  the  scientific  opinions  delivered  by  the  Centre  relating  to
foreseeable health effects shall on no account be kept confidential.

The  Centre  shall  lay  down  in  its  internal  rules  the  practical  arrangements  for
implementing the confidentiality rules referred to in paragraphs 1 and 2.

CHAPTER 5

FINANCIAL PROVISIONS

Article 22

Drawing up of the budget

Estimates of all the revenue and expenditure of the Centre shall be prepared for each
financial year, corresponding to the calendar year, and shall be shown in the budget
of the Centre.

7

OJ L 8, 12.1.2001, p. 1.

26

                                                
2.

3.

4.

5.

6.

7.

8.

9.

The revenue and expenditure shown in the budget of the Centre shall be in balance.

The revenue of the Centre shall, without prejudice to other resources, comprise:

(a) A subsidy form the Community entered in the general budget of the European

Union (Commission section);

(b)

Payments received for services rendered;

(c) Any financial contributions from the organisations referred to in Article 5;

(d) Any voluntary contribution from the Member States

The  expenditure  of  the  Centre  shall  include  staff  remuneration,  administrative  and
infrastructure  costs,  operating  expenses  and  expenses  resulting  from  contracts
entered into with the institutions or with third parties.

Each year the Management Board, on the basis of a draft drawn up by the Director,
shall produce an estimate of revenue and expenditure for the Centre for the following
financial year. This estimate, which shall include a draft establishment plan, shall be
forwarded by the Management Board to the Commission by 31 March at the latest.

The estimate shall be forwarded by the Commission to the European Parliament and
the  Council  (hereinafter  referred  to  as  the  "budgetary  authority")  together  with  the
preliminary draft budget of European Union.

On  the  basis  of  the  estimate,  the  Commission  shall  enter  in  the  preliminary  draft
general  budget  of  the  European  Union  the  estimates  it  deems  necessary  for  the
establishment  plan  and  the  amount  of  the  subsidy  to  be  charged  to  the  general
budget, which it shall place before the budgetary authority in accordance with Article
272 of the Treaty.

The  budgetary  authority  shall  authorise  the  appropriations  for  the  subsidy  to  the
Centre. The budgetary authority shall adopt the establishment plan for the Centre.

The budget of the Centre shall be adopted by the Management Board. It shall become
final following final adoption of the  general  budget of the European Union. Where
appropriate, it shall be adjusted accordingly.

10.

The Management Board shall, as soon as possible, notify the budgetary authority of
its  intention  to  implement  any  project  which  may  have  significant  financial
implications  for  the  funding  of  its  budget,  in  particular  any  projects  relating  to
property such as the rental or purchase of buildings. It shall inform the Commission
thereof.

Where  a  branch  of  the  budgetary  authority  has  notified  its  intention  to  deliver  an
opinion, it shall forward its opinion to the Management Board within a period of six
weeks from the date of notification of the project.

27

1.

2.

3.

4.

5.

6.

7.

8.

9.

Article 23

Implementation of the Centre's budget

The Director shall implement the Centre's budget.

By  1  March  at  the  latest  following  each  financial  year,  the  Centre's  accounting
officer shall communicate the provisional accounts to the  Commission's  accounting
officer  together  with  a  report  on  the  budgetary  and  financial  management  for  that
financial year. The Commission's accounting officer shall consolidate the provisional
accounts of the institutions and decentralised bodies in accordance with Article 128
of the general Financial Regulation.

By  31  March  at  the  latest  following  each  financial  year,  the  Commission's
accounting  officer  shall  forward  the  Centre's  provisional  accounts  to  the  Court  of
Auditors, together with a report on the budgetary and financial management for that
financial  year.  The  report  on  the  budgetary  and  financial  management  for  that
financial year shall also be forwarded to the European Parliament and the Council.

On  receipt  of  the  Court  of  Auditors'  observations  on  the  Centre's  provisional
accounts,  pursuant  to  Article  129  of  the  general  Financial  Regulation,  the  Director
shall  draw  up  the  Centre's  final  accounts  under  his/her  own  responsibility  and
forward them to the Management Board for an opinion.

The Management Board shall deliver an opinion on the Centre's final accounts.

The Director shall, by 1 July at the latest following each financial year, forward the
final  accounts  to  the  European  Parliament,  the  Council,  the  Commission  and  the
Court of Auditors, together with the Management Board's opinion.

The final accounts shall be published.

The  Director  shall  send  the  Court  of  Auditors  a  reply  to  its  observations  by
30 September  at  the  latest.  He/she  shall  also  send  this  reply  to  the  Management
Board.

The  Director  shall  submit  to  the  European  Parliament,  at  the  latter's  request,  any
information  required  for  the  smooth  application  of  the  discharge  procedure  for  the
financial  year  in  question,  as  laid  down  in  Article 146(3)  of  the  general  Financial
Regulation.

10.

The  European  Parliament,  on  a  recommendation  from  the  Council  acting  by  a
qualified  majority,  shall,  before  30  April  of  year  N  +  2,  give  a  discharge  to  the
Director in respect of the implementation of the budget for year N.

28

Article 24

Application of the Financial Regulation

Article  185  of  the  general  Financial  Regulation  of  25  June  2002  applicable  to  the  general
budget  of  the  European  Communities  applies  for  the  discharge  of  the  Centre’s  budget,  its
audits, and accounting rules.

1.

2.

3.

1.

2.

1.

Article 25

Combating fraud

In order to combat fraud, corruption and other unlawful activities, the Provisions of
Regulation (EC) No 1073/1999 shall apply without restriction to the Centre.

The Centre shall accede to the Inter-institutional Agreement of May 1999 concerning
internal  investigations  by  the  European  Anti-Fraud  Office  (OLAF)  and  shall  issue,
without delay, the appropriate provisions applicable to all of it’s staff.

The decisions concerning funding and the implementing agreements and instruments
resulting  from  them  shall  explicitly  stipulate  that  the  Court  of  Auditors  and  OLAF
may  carry  out,  if  necessary,  on-the-sport  checks  of  the  recipients  of  the  Centre’s
funding and the agents responsible allocating it.

CHAPTER 6

GENERAL PROVISIONS

Article 26

Legal personality and privileges

The Centre shall have legal personality. In all Member States it shall enjoy the widest
powers granted by law to legal persons. In particular, it may acquire and dispose of
movable and immovable property and institute legal proceedings.

The  Protocol  on  the  privileges  and  immunities  of  the  European  Communities  shall
apply to the Centre.

Article 27

Liability

The contractual liability of the Centre shall be governed by the law applicable to the
contract in question. The  Court of Justice of  the European Communities shall have
jurisdiction  to  give  judgement  pursuant  to  any  arbitration  clause  contained  in  a
contract concluded by the Centre.

29

2.

3.

1.

2.

3.

1.

2.

3.

1.

In  the  case  of  non-contractual  liability,  the  Centre  shall,  in  accordance  with  the
general  principles  common  to  the  laws  of  the  Member  States,  make  good  any
damage caused by it or its servants in the performance of their duties. The Court of
Justice  shall  have  jurisdiction  in  any  dispute  relating  to  compensation  for  such
damage.

The  personal  liability  of  its  servants  towards  the  Centre  shall  be  governed  by  the
relevant provisions applying to the staff of the Centre.

Article 28

Examination of legality

Member States, members of the Administrative Board and third parties directly and
personally  involved  may  refer  to  the  Commission  any  act  of  the  Centre,  whether
express or implied, for the Commission to examine the legality of that act.

Referral shall be made to the Commission within fifteen days of the day on which the
party concerned first became aware of the act in question.

The  Commission  shall  take  a  decision  within  one  month.  If  no  decision  has  been
taken within this period, the case shall be deemed to have been dismissed.

Article 29

Staff

The Staff  Regulations of officials of the  European  Communities,  the  Conditions  of
employment  of  other  servants  of  the  European  Communities  and  the  rules  adopted
jointly  by  the  institutions  of  the  European  Communities  for  purposes  of  the
application of those Staff Regulations and Conditions of employment shall apply to
the staff of the Centre.

The powers  conferred  on  the appointing  authority by  the  Staff  Regulations,  and  by
the Conditions of employment of other servants, shall be exercised by the Centre in
respect of its own staff.

The  Centre's  staff  shall  consist  of  a  strictly  limited  number  of  officials  assigned  or
seconded by the Commission or Member States to carry out management duties. The
remaining staff shall consist of other employees recruited by the Centre as necessary
to carry out its tasks.

Article 30

Participation of third countries

The  Centre  shall  be  open  to  the  participation  of  countries,  which  have  concluded
agreements with the European Community by virtue of which they have adopted and
apply legislation  of  equivalent effect  to Community  legislation in  the  field  covered
by this Regulation.

30

2.

1.

2.

Arrangements  shall  be  made  under  the  relevant  provisions  of  those  agreements,
specifying in particular the nature, extent and manner in  which these countries  will
participate in the Centre's work, including provisions relating to participation in the
networks operated by the Centre, inclusion in the list of competent organisations to
which certain tasks may be entrusted by the Centre, financial contributions and staff.

CHAPTER 7

FINAL PROVISIONS

Article 31

Review clause

No later than three years after the entry into force of this regulation the Centre shall
commission  an  independent  external  evaluation  of  its  achievements  on  the  basis  of
terms  of  reference  issued  by  the  Management  Board  in  agreement  with  the
Commission. The evaluation will assess the tasks of the Centre, in particular its role
in  health  monitoring,  the  working  practices  and  the  impact  of  the  Centre  on
prevention  and control  of  human  disease.  The  future  financing  needs  of  the  Centre
for the period after N+2 will be decided in the light of this evaluation. The evaluation
will take into account the views of the stakeholders, at both Community and national
level.

The Management Board shall examine the conclusions of the evaluation and issue to
the  Commission  such  recommendations  as  may  be  necessary  regarding  changes  in
the Centre and its working practices. The evaluation report and the recommendations
shall be forwarded to the Council and the European Parliament and made public.

Article 32

Commencement of the centre’s operation

The  Centre  shall  be  operational  within  twelve  months  of  the  entry  into  force  of  this
Regulation.

The Centre is situated in […].

Article 33

Entry into force

This Regulation shall enter into force on the […20th] day following that of its publication in
the Official Journal of the European Union.

31

Article 34

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

32

LEGISLATIVE FINANCIAL STATEMENT

Policy area(s): Health and Consumer Protection (SANCO, Title 17)

Activity/Activities: Public Health (Chapter 17.03)

TITLE  OF  ACTION:  PROPOSAL  FOR  A  REGULATION  OF  THE  EUROPEAN  PARLIAMENT  AND  OF
THE  COUNCIL  ESTABLISHING  A  CENTRE  FOR  IMPROVING  DISEASE  PREVENTION  AND
CONTROL  IN  THE  EUROPEAN  COMMUNITY  AT  MEMBER  STATE  LEVEL.  (ECDPC:
EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL)

1.

BUDGET LINE(S) + HEADING(S)

For the purposes of creating the Centre, two new operational budget lines are needed in
the Community budget to cover subsidy of administrative (Titles I and II) and operating
(Title  III)  expenditure.  The  appropriations  will  be  allocated  on  an  annual  basis  in
accordance  with  the  current  procedures  of  the  general  budget  of  the  European
Communities.

As  subdivisions  of  chapter  17 03,  these  new  budget  lines  could  be  designated  items
17 03 03 01  (ECDPC  –  Subsidy  of  administrative  expenditure  –  Titles  I  and  II)  and
17 03 03 02 (ECDPC – Subsidy of operating expenditure – Title III).

2.

2.1

OVERALL FIGURES

Total  allocation  for  action  (from  n  to  n+2):  €  47.835  million  for  commitment
(CA)

The present financial statement provides detailed information for the start-up period
until the  year  n+2. The  adequacy  of  current  and  future  funding  in  n+3  and  beyond
will  be  evaluated  through  a  review,  which  will  take  place  during  year  n+2  at  the
latest.

2.2

Period of application:

Start 2005.

Indefinite.

2.3

a)

Overall multiannual estimate of expenditure:

Subsidy of operational expenditure (Title III) (budget line 17 03 03 02)

(cf. breakdown in point 6.2.).

33

€ million (to 3 decimal places)

Year n
[2005]

[n+1]
(2006)

[n+2]
(2007)8

Total
Years
 n to n+2

1.462

8.524

20.672

30.658

1.462

8.524

20.672

30.658

Commit-
ments (CA)

Payments
(PA)

b)

Subsidy of administrative expenditure (Titles I and II) (budget line 17 03 03 01)

(cf. . breakdown in point 6.4.3).

(2005)

(2006)

(2007)

TOTAL

CA

PA

3.291

3.291

5.779

5.779

8.107

8.107

Years
 n to n+2

17.177

17.177

TOTAL

(2005)

(2006)

(2007)

TOTAL

Years
 n to n+2

CA

PA

4.753

4.753

14.303

28.779

47.835

14.303

28.779

47.835

c)

Complementarity with the Public Health Programme (budget line 17 03 01 01)

The Centre will be funded from the Community budget, based on a proposal from the
Commission  and  approved  by  the  Budgetary  Authority.  Total  annual  costs  at  the
beginning of its operation would be around € 9.6 million in 2005 and € 20.3 million
in 2006. Given the budget constraints under the financial perspectives for Heading 3,
DG SANCO agrees exceptionally to fund from its own resources, i.e. Public Health
Programme  €  4.9  million  in  2005  and  €  6  million  in  2006,  thus  reducing  the  net
amounts of new additional funds to € 4.7 million in 2005 and € 14.3 million in 2006.

8

For  information.  These  appropriations  will  not  affect  the  amounts  adopted  for  the  next  financial
perspective.

34

                                                
The  Annual  Policy  Strategy  for  2003  (SEC(2002)217/9  of  27/02/02)  proposed
earmarking €10.6 million (see table below) within the new Public Health Programme
for  financing  the  additional  expenditure  involved  in  setting  up  the  Centre  and  the
administrative cost of paying for external consultants. The funds are principally to be
used  for  the  prior  development  of  networks  and  feasibility  studies  of  recognised
value for the Centre’s future activities, prior to its creation and for the first 18 months
of its operation. In addition to this € 10.6 million, the Public Health Programme will
finance part of the Centre's activities to the tune of € 1.5 million per year for the first
two years of its operation (2005 and 2006). These amounts will be provided from the
Programme's additional funds for enlargement.

Financial
resources from
the Public
Health
Programme

Annual  Policy
Strategy 2003

Enlargement

TOTAL

2003

2004

2005

2006

Total

€ 1.3 million

€ 1.4 million

€ 3.4 million

€ 4.5 million

€ 10.6
million

€ 1.5 million

€ 1.5 million

€ 3 million

€ 1.3 million

€ 1.4 million

€ 4.9 million

€ 6 million

€ 13.6
million

The  Centre  will  be  operational  from  n+2  (2007).  The  communicable  disease
networks formally established on the basis of Annex I of Decision 2000/96/EC and
in  application  of  Decision  2119/98/EC  will  enter  an  operational  phase  and  will  be
fully functional. It will therefore be possible to fund all expenditure relating to these
networks from the Centre’s budget from 2007.

2.4

Compatibility with financial programming and financial perspective

[X] Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the  financial

perspective.

2.5

Financial impact on revenue

[X] Proposal  has  no  financial  implications  (involves  technical  aspects  regarding

implementation of a measure).

The existence of possible revenues will be part of the evaluation foreseen at the end
of  n+2.  If  revenues  are  identified,  it  is  expected  that  they  will  contribute  to  the
financing of the Centre.

35

3.

BUDGET CHARACTERISTICS

Type of expenditure

New

EFTA
contribution

Contributions
from
applicant
countries

FP heading

Diff

YES

YES

YES

No [3]

Comp /
Non-comp

4.

LEGAL BASIS

Article 152 (4) of the Treaty establishing the European Community

5.

5.1

DESCRIPTION AND JUSTIFICATION

Need for Community intervention

5.1.1

Objectives pursued

This  proposal  establishes  an  entirely  independent  European  Agency,  “The  European  Centre
for Disease Prevention and Control (ECDPC)” with its own legal personality. The Centre will
contribute  to  increasing  Member  States’  disease  prevention  and  control  capacity  by
coordinating surveillance of health threats within the Community. It will develop and manage
the  capacity  to  react  quickly,  effectively  and  coherently  to  health  threats  and  will  set  up  a
coordination system enabling the Community to respond to situations potentially affecting the
health of European citizens, in particular management of health crises and epidemics.

5.1.2 Measures taken in connection with ex ante evaluation

There  are  three  external  evaluations  done  on  the  Community  Network.  The  first  evaluation
focuses on the existing structures and weak points in its functioning and the second looks to
the future - what would be the best option to create an EU level response capacity. In 2002 the
State  Epidemiologists  from  the  Member  States  gave  their  view  on  the  future  of  the
surveillance of communicable diseases at the EU level.

In addition an evaluation in 2002 of the operation of the Community network carried out by
SANCO, but for which Member States within the Committee of the Network (‘comitology’),
endorsed  the  recommendations.  This  evaluation  also  concluded  in  favour  of  a  coordinating
Centre.

These evaluations are in line with the conclusions of the European Council at Gothenburg in
June  2001,  the  extraordinary  meeting  of  the  Council  of  the  European  Union  (Employment,
Social policy, Health and Consumer Affairs) on 6 May 2003 and the meeting of the European
Council  on  2  June  2003,  where  the  need  for  a  more  structured  approach  at  the  Community
level was recognised. At the last two meetings of Health Ministers the Commission's intention
to submit a proposal to create a European Centre for disease prevention and control was also
widely supported.

Recently the SARS outbreak showed clearly the lack of  capacity to deal with serious health
threats  at  the  Community  level  and  the  existing  need  to  enhance  capacity.  With  the  SARS
outbreak the Community was lucky, with only a limited number of imported cases, which did

36

not arrive by surprise as in Toronto. There were no deaths or local transmission of SARS in
the European  Union. The  next time could well be a pandemic  (unknown disease,  influenza,
bio-terrorism) with severe consequences.

One alternative would require a larger dedicated Commission structure which would inter alia
lack the flexibility of access to specialised staff and appropriate scientific advice.

5.1.3 Measures taken in connection with ex post evaluation

Not applicable.

5.2

Actions envisaged

The mission of the Centre is to enhance the capacity of the European Union and its Member
States to promote health by the prevention and control of disease.

The Centre would be able to coordinate and link activities in the Member States, in other EU
structures and with international organisations, such as the WHO, to achieve one focused and
effective response at the Community level.

Surveillance

The  Centre  would  develop  epidemiological  surveillance  at  Community  level.  The  Centre
would gradually take over the technical aspects of activities of existing dedicated surveillance
networks  formally  structured  under  the  Community  Network  (Decision  2119/98/CE),  either
with  its  own staff or  subcontracting  national  institutes,  and  could  better  define  the  scope  of
action  of  new  ones.  This  gradual  integration  of  epidemiological  surveillance  will  lead  to  a
harmonised surveillance methodology, including better comparability and compatibility of the
surveillance data collected in the Member States. The Centre could also set up and maintain
the  network  of  reference  laboratories,  and  enhance  the  quality  assurance  schemes  of
microbiological laboratories.

Alert and response

With  an  operational  Centre  the  responsibility  for  running  the  early  warning  system  set  up
under  Decision  2000/57/EC  and  assisting,  on  request,  in  the  risk  assessment,  decision-
making, and appropriate deployment of assistance would be in one place. The Centre would
act  in  coordination  with  various  Community  agencies  (e.g.  EFSA,  EMEA,  EEA)  and  with
other  alert  systems  such  as  GOARN/WHO,  when  appropriate.  It  would  also  advise  the
Commission  in  its  risk  management  tasks.  The  Centre  could  guarantee  around  the  clock
availability of expertise to maintain its co-ordinating role.

Preparedness and control of outbreaks

Response is a key element in preparedness and control of outbreaks. Resolving the problems
in a limited outbreak prevents its deterioration into a wider crisis.

The Centre should have a role in the coordination of specific responses and activities to limit
the  epidemic  and  contain  its  effects.  In  practice  this  means  mobilising  experts  from  the
Member  States  into  the  Community  investigation  teams,  giving  expert  advice  and  technical
help in defining measures to contain the epidemic at national and at the Community level. To

37

enable  it  to  fulfil  its  tasks  in  these  situations  there  should  be  financial  mechanisms  which
allow mobilisation of personnel and equipment.

5.3

Methods of implementation

During 2003 and 2004, external experts will be used to prepare the integration of surveillance
networks  into  the  Centre.  Projects  dealing  with  capacity  building  and  dissemination  of
information  could  be  the  ones  to  be  integrated  from  the  beginning.  At  the  same  time  the
evaluation of disease surveillance networks will start to assess their surveillance methods and
whether the objectives have been reached. It is important to get the laboratories involved in
surveillance  also  at  the  Community  level.  To  this  end,  the  Commission  will  enhance  the
development of laboratory networks, including those European laboratories with the capacity
to  handle  highly  contagious  micro-organisms,  like  smallpox  virus.  The  Commission  will
maintain  and  update  the  support  databases  and  develop  the  Early  Warning  and  Response
system  (EWRS)  further.  The  procedures  for  effective  exchange  of  information  will  also  be
developed. Once in place, the Centre will set up an intervention team in collaboration with the
Member States and the WHO. High quality surveillance, early warning, and response are not
possible  without  trained  specialists  with  a  variety  of  expertise  at  national  and  Community
level. To build up European capacity, continuous training will be supported and its financing
will be sustained.

The  work  of  the  Task  Force  against  deliberate  release  of  chemicals  and  biological  agents
(BICHAT) will be evaluated and, according to the results, transferred to the Centre.

In this  way the  Commission expects that,  as and when Parliament  and Council  agree  to  the
principles, mandate  and form of  the  Centre,  these  preliminary  tools  and  processes  might  be
integrated rapidly so that it could become fully operational in a very short time.

The evaluation envisaged in Article 31 will assess the tasks of the Centre, in particular its role
in  health  monitoring,  the  working  practices  and  the  impact  of  the  Centre  on  prevention  and
control of human disease. The future  financing needs  of the Centre  for  the period  after n+2
will be decided in the light of this evaluation.

6.

TOTAL  FINANCIAL  IMPACT  (SUBSIDY  OF  ADMINISTRATIVE  (TITLES  I  ET  II)  AND
OPERATING (TITLE III) EXPENDITURE)

6.1

Basis for calculation of administrative costs

The Centre's administrative costs have been calculated on the basis of an independent entity,
i.e. one which does not depend on the Commission's infrastructure.

The personnel costs (salaries + contributions) are based on the annual average used within the
Commission  of  €  0.108  million  per  year  per  official/temporary  agent,  and  are  estimated  at
72% of this average, i.e. € 0.08 million per year per official/temporary agent.

Start-up funding will be needed for period n, which will commence on the date of adoption of
this Regulation as, during the first few years of its operation, the Centre will incur additional
costs to cover, inter alia:

- advertising of posts and recruitment

- office equipment

38

- software acquisition and development

- the fact that the Agencies have a higher average percentage of A-grade staff than the
Commission average.

The  remaining  administrative  expenditure  (furniture,  computer  equipment,  etc.)  is  based  on
the actual rates used at the Commission's centres of activity.

Concerning expenditure on buildings, the estimated average area needed per person is 35 m²
(offices, meeting rooms, archives, computer room, common areas such as corridors). On this
basis, a surface area of around 1 750 m² would be required for the 50 staff envisaged for the
first  two  years  of  the  Centre's  operation  and  for  the  organisation  of  scientific  meetings  and
network  coordination  activities.  At  an  estimated  rent  of  €  172  per  m²  per  year,  the  annual
building rental cost would be € 0.301 million for years n (2005) and n+1 (2006), depending
on where the headquarters are to be located, to be confirmed by the European Council.

6.1.1 First year of operation (2005)

A subsidy of € 4.753  million will be required for the first year of operation.

a) Personnel costs
(salaries + contributions) (see point 6.4.3)
b) Administrative expenditure
(IT, buildings, etc.) (see point 6.4.3)
c) Operating costs (see point 6.2)
d) Expenditure on concerted actions
Total

 € 1.215 million

€ 2.076 million

€ 0.462 million
€ 1.000 million
€ 4.753 million

a) Personnel expenditure (€ 1.215 million)

For the start-up phase, the staff will number 35. They are expected to be in place by the end
of 2005 and will be responsible for the set-up and initial operational phase of the new Centre.

Estimated  expenditure  on  staff  for  the  first  year  of  operation  is  based  on  an  average  of  15
man/year posts for calculating the wage cost.

b) Administrative expenditure (€ 2.076 million)

Part of the administrative expenditure is accounted for by start-up investment in computer and
telematic equipment (hardware, software, information systems), estimated at € 0.8 million for
2005. Estimated expenditure on information technology/office equipment required for start-up
of the Centre's activities is € 1.5 million for the first year of operation.

The  buildings  and  infrastructure  costs  included  in  the  start-up  estimate  represent  the  total
rented space needed for the 50 staff envisaged. The corresponding  investment schedule  will
depend largely on the decision regarding the Centre's headquarters (see point 6.1).

Cost of meetings (€ 0.176 million)

Basis for calculation:

1) Journey to/from meeting: € 800 per person and

39

2)  €  150  for  daily  allowances,  if  necessary  adding  logistical,  interpreting,  translation  costs,
etc.

–  Management Board (15 MS reps., 10 experts): 3 x 2-day meetings

3 meetings x 25 persons x € 1 100 (cid:1) € 82 500

–  Advisory Forum (25 MS reps., 1 COM rep., 1 EP rep.): 4 x 3-day meetings

3 meetings x 25 persons x € 1 250 (cid:1) € 93 750

Cost of staff assignments ( € 0.05 million) (see table 6.4.3)

This  estimate  is  based  on  the  actual  expenditure  of  comparable  agencies  and  specific  job
descriptions in the various fields of activity. The estimated cost per assignment is € 800 per
day for Europe and € 1 200 per day for the rest of the world.

Translation/interpreting costs (€ 0.05 million)

The cost of translations is calculated on an average standard rate of € 76 per translated page

c) Operating expenditure (€ 0.462 million)

This covers the 15 2-day meetings of experts for the first year.

Basis for calculation:

1) Journey to/from meeting: € 800 per person and

2) € 150 for daily allowances

-  Scientific  meetings  (disease  surveillance,  scientific  panels)  of  28  persons  (25  MS  reps.,  3
EFTA reps. 1 COM rep.): 15 meetings x 28 persons x € 1100 = € 0.462 million

d) Operating expenditure – concerted actions (€ 1 million)

In the course of its disease surveillance and control activities, the Centre may be called upon
to deal with individual public health emergency situations. The research and response request
time must be rapid, and the Agency must therefore have access to operating funds.

An  initial  amount  of  €  1  million  could  be  allocated  for  this  purpose  from  the  Community
budget  for  the  first  year  of  the  Centre's  operation  (initial  phase).  This  would  be  reviewed
annually under the budget procedure. The evaluation provided for under Article 31 will also
cover this aspect.

The Agency  would make use of these  funds  only  in  the  event  of  crisis.  If  part  or  all  of  the
funds  are  unused,  the  unused  amount  will  automatically  lapse  and  will  not  be  added  to  the
amount requested under the budgetary procedure for the following year. This means that new
appropriations  will  have  to  be  applied  for  under  the  budgetary  procedure  for  the  following
year.

Particular attention  should  also  be  paid  to this funding  when evaluating  the  Centre's  overall
resources at n+3 (cf. Article 31 of the Regulation).

40

6.1.2.

Second year of operation (2006)

A subsidy of € 14.303 million will be required for the second year of operation.

a) Personnel costs
(salaries + contributions) (see point 6.4.3)
b) Administrative expenditure
(IT, buildings, etc.) (see point 6.4.3)
c) Operating costs (see point 6.2)
d) Operating costs – concerted actions
Total

 € 3.816 million

€ 1.963 million

€ 6.524 million
€ 2.000 million
€ 14.303 million

The  increase  in  the  subsidy  is  due  principally  to  the  increase  in  the  Centre's  activities.  The
additional staff (rising to 50) and integration of the networks into the Centre will necessarily
entail  a  rise  in  administrative  costs  (missions,  translation/interpreting)  and  operating  costs
(training, surveillance,  scientific studies, meetings  of  experts  (based  on  4  meetings  per  year
per network)).

6.1.3

Third year of operation (2007)9

a) Personnel costs
(salaries + contributions) (see point 6.4.3)
b) Administrative expenditure
(IT, buildings, etc.) (see point 6.4.3)
c) Operating costs (see point 6.2)
d) Operating costs – concerted actions
Total

 € 5.436 million

€ 2.671 million

€ 17.672 million
€ 3.000 million
€ 28.779 million

This year is marked by the continued development of the Centre's activities, and in particular
an estimated increase in staff to 70 by the end of 2007.

Depending  on  the  results  of  the  evaluation  during  year  n+2,  the  resources  needed  for  the
Centre  will  be  reviewed.  The  competent  department  is  currently  basing  its  estimates  on  an
ultimate staffing level of 98 persons.

Operating expenditure for n+2 can be broken down as follows:

- Dedicated Surveillance Networks € 7 million

- Training/placement programme € 4 million

- Scientific studies € 2 million

- Material and equipment € 1.5 million

- Scientific meetings € 2.772 million (based on 4 meetings per year per network)

- Information/publication/other € 0.400 million.

9

For  information.  These  appropriations  will  not  affect  the  amounts  adopted  for  the  next  financial
perspective.

41

                                                
Ultimately,  the  "other"  operating  expenditure  will  comprise  the  cost  of  collecting  and
disseminating information, publication of reports, organisation of seminars, evaluations/audits
and the technical library (books).

6.2

(Subsidy of operating expenditure – Title III)

The  subsidy  of  operating  expenditure will  be  covered  by  an  operational  heading  in
the Community budget (17 03 03 02).

Commitments (in € million to three decimal places)

Breakdown

[Year n]

[n+1]

[n+2]10

2005

2006

2007

Total
 Years
 n to n+2

Dedicated  Surveillance

0.00

2.500

7.000

9.500

Networks

Training/placement

0.00

1.500

4.000

5.500

programme

-Scientific studies

0.00

0.600

2.000

2.600

Materials and equipment

0.00

0.500

1.500

2.000

Expenditure 

on

1.000

2.000

3.00011

6.000

concerted actions

Meeting of experts

0.462

1.124

2.772

4.358

Information 
publications

and

0.000

0.300

0.400

0.700

10

11

For  information.  These  appropriations  will  not  affect  the  amounts  adopted  for  the  next  financial
perspective.
For  information.  These  appropriations  will  not  affect  the  amounts  adopted  for  the  next  financial
perspective.

42

                                                
TOTAL 1.462

8.524

20.672

30.658

6.3

Details of activities envisaged for the Centre (without prejudice to the outcome
of the evaluation at n+2)

The mission of the Centre is to analyse and assess risks to human health from communicable
diseases and other serious health threats, to provide expert advice to the Commission and the
Member States and to enhance the capacity of the European Union and its Member States to
protect human health through prevention and control measures on communicable diseases and
other serious health threats. The capacity of the Centre comprises its own resources and those
of  agents,  institutes,  and  other  bodies  acting  on  behalf  of  Member  States’  authorities
competent  for  health.  The  primary  objective  of  the  Centre  shall  be  to  co-operate  with  the
Member States in order to achieve coherent, timely, and effective actions.

Task 1 Scientific support and training

The Centre shall provide the Community Institutions and the Member States with the
best  possible  scientific  opinions  based  on  information  from  dedicated  surveillance
networks and other authoritative scientific sources. Where the best possible scientific
expertise is not available within the Centre or in the dedicated surveillance networks
the Centre may set up ad hoc scientific panels for this purpose. Member States shall
supply the necessary scientific assistance available to them.

Task 2 Networking  of  organisations  operating  in  the  fields  within  the  Centre’s
competence,  collection  and  analysis  of  data,  identification  of  emerging  risks,  and
preparedness for crises

The  Centre  shall,  with  the  support  of  the  Member  States,  maintain  and  extend  the
networking  activities  and  dedicated  surveillance  networks  of  authorities  and
structures  designated  under  Community  legislation  and  integrate  them  into  its
operation by strengthening their technical and scientific support, and by monitoring
and evaluating their surveillance activities.

The  Centre  shall  establish  surveillance  procedures  for  systematically  searching  for,
collecting,  collating  and  analysing  information  and  data  with  a  view  to  the
identification of emerging risks within its competence.

The  Centre  shall  search  for,  collect,  collate,  analyse  and  summarise  relevant
scientific  and  technical  data  in  its  fields  of  competence.  This  shall  involve  in
particular  the  collection  of  data  relating  to  operation  of  Decision  2119/98/EC,  and
information  concerning  existing  and  proposed  mechanisms  and  procedures  for
control of health threats.

For the purposes of paragraph 1, the Centre shall work in close co-operation with the
organisations operating in the field of data collection, including those from applicant
countries, third countries, and international organisations.

43

Task 3 Early warning and response

Member  States  shall  in  a  timely  way  communicate  to  the  Centre  any  messages
forwarded  via  the  Early  Warning  and  Response  System  (EWRS)  under  the
provisions of Decision 2000/57/EC.

The  Centre  shall,  under  the  overall  control  of  the  Commission,  mobilise  and  co-
ordinate investigation teams and concerted actions in situations where health may be
affected within or outside the Community in co-operation with the Commission, the
Member States, Candidate Countries, third countries, and international organisations.

Task 4 Communications from the Centre

The  Centre  shall  communicate  on  its  own  initiative  in  the  fields  within  its
competence, without prejudice to the Commission's competence to communicate its
own  decisions.  It  shall  ensure  that  the  public  and  any  interested  parties  are  rapidly
given objective, reliable and easily accessible information, in particular with regard
to  the  results  of  its  work.  In  order  to  achieve  these  objectives,  the  Centre  shall
develop and disseminate information material for the general public.

Task 5 Administration and support

Depending on the outcome of the evaluation at n+2, the administrative and support
functions may be changed.

To  safeguard  the  quality  objectives  and  ensure  effective  operation,  the  Centre  will
operate an internal and external evaluation system (peer reviews, benchmarking and
audits).

The following meetings and costs are envisaged:

Management Board

Advisory Forum and working parties

Meetings

Days

Participants

3

4

2

3

25

28

6.4

Breakdown  of  subsidy  of  administrative  expenditure  (Titles  I  and  II)  (line
17 03 03 01)

6.4.1

The Centre's human resources

Staffing in 2005 (year n)

Staff to be assigned to management of the
measure using new resources

Description of the tasks deriving
from the action

Type of post

Total

Number of
permanent posts

Number of
temporary posts

16A, 7B, 6C

29

Officials or
temporary staff

A

B

If necessary, a more detailed
description of the tasks may be

44

C

annexed

Other human resources

 6 "C" AUX

Total

35

6

35

Staffing in 200712

Type of post

Officials or
temporary staff

A

B

C

Staff to be assigned to management of the
measure using existing or additional
resources

Total

Number of
permanent posts

Number of
temporary posts

5A, 4B, 3C

34A, 7B, 11C

64

Description of tasks deriving
from the action

The personnel of the Centre will be
highly specialised (such as
epidemiologists, public health
specialists, microbiologists,
virologists, logisticians, IT experts)
or for administrative functions of
the Centre.

Other human resources

6 "C" AUX

Total

12

58

Development of staffing levels 2005(cid:1)2007

6

70

Type of human
resources

(Year n)
2005

(n+1)
2006

(n+2)13
2007

Officials

Temporary staff

Other human
resources

29

6

+  15  (9  "A",
2 "B", 4 "C")

+20 (14 "A",
2 "B", 4 "C")

Total

35

50

70

Without prejudice to the outcome of the evaluation envisaged in n+2 (2007), and depending
on the opinion of the competent  departments,  the  Centre  could  ultimately  employ  a  staff  of
98.

12

13

For  information.  These  appropriations  will  not  affect  the  amounts  adopted  for  the  next  financial
perspective.
For  information.  These  appropriations  will  not  affect  the  amounts  adopted  for  the  next  financial
perspective.

45

                                                
6.4.2

Overall financial impact of Centre's human resources

Year 2005:

Type of human resources

Amount in euro

Method of calculation *

Agents

1 215 000

€ 81 000 x 15

Total

1 215 000

The amounts represent total expenditure over 12 months for an average of 15/35 permanent
posts because of the difficulty of recruiting in the first year.

Year 2007:

Type of human resources

Amount in euro

Method of calculation *

Agents

5 184 000

€ 81 000 x 64

Other human resources, ‘C’ auxiliaries

252 000

€ 42 000 x 6

Total

5 436 000

The Centre will take over the technical activities of the 1 ‘A’ grade, 2 ‘B’ grades, 1 ‘C’ grade
together with the 8 ENDs (seconded national experts) (financed hors quota) from the Bichat
team  (bio-terrorism  task  force).  The  economy  of  1  ‘A’  official  could  be  made  from  some
technical activities in support of the Community network.

However, there will be a need for a liaison function in the Commission of approximately the
same number of staff.

Therefore,  the  net  effect  of  resources  in  the  Commission  (SANCO)  will  be  zero  with  the
exception of the 8 ENDs of the Bichat team.

46

6.4.3 Total subsidy of the Centre's administrative expenditure (line 17 03 03 01) for the first 3

years

The subsidy of administrative expenditure will be covered by an operational heading of

the Community budget (17 03 03 01).

Million EUR

(Year n)
2005

(n+1)
2006

(n+2)14
2007

TOTAL
Years
n to n+2

Human resources

35

50

70

70

15 agents

44  agents,  6
externals

64  agents,  6
externals

64  agents,  6
externals

Calculation basis

Annual  cost  of
human
resources

Other
administrative
expenditure

Missions

Management
Board meetings

Advisory  Forum
meetings

Interpreting/transl
ation

1.215

3.816

5.436

10.467

0.050

0.200

0.200

0.500

0.082

0.082

0.082

0.246

0.093

0.093

0.093

0.279

0.050

0.287

0.294

0.631

office

1.500

1.000

1.400

3.900

0.301

0.301

0.602

1.204

IT  & 
equipment

Buildings
expenditure

Other

Total 
administrative
expenditure

2.076

1.963

2.671

6.710

Total

3.291

5.779

8.107

17.177

14

For  information.  These  appropriations  will  not  affect  the  amounts  adopted  for  the  next  financial
perspective.

47

                                                
7.

7.1

FOLLOW-UP AND EVALUATION

Follow-up arrangements

The  European  Commission  will  be  in  daily  contact  with  the  Centre,  which  may  give  an
opinion  on  questions  submitted  to  it  by  the  Commission.  The  extent  to  which  the  Centre
meets its agreed deadlines and objectives will be an objective indicator of its performance.

The  proposed  regulation  provides  (31)  that,  within  three  years  of  the  Centre  taking  up  its
activities, the Commission shall draft a report on its implementation and effectiveness, where
appropriate making proposals for changes to or extension of its activities. The report will also
include  an  assessment  of  the  adequacy  of  the  financial  and  human  resources  and
recommendations to ensure the Centre's proper functioning over subsequent years.

7.2

Arrangements and schedule for the planned evaluation

■  The  overall  evaluation  of  the  Centre's  activities  proposed  in  Article  31  of  the
Regulation  will  help  to  ensure  that  the  Centre  is  responding  to  the  Commission’s
needs. If necessary, a mechanism will be put in place to adapt  those  activities. The
conclusions of the evaluations will be made public.

■  No  later  than  three  years  after  the  entry  into  force  of  this  Regulation  the  Centre
shall commission an independent external evaluation of its achievements on the basis
of  terms  of  reference  issued  by  the  Management  Board  in  agreement  with  the
Commission.  The  evaluation  will  assess  the  tasks  of  the  Centre  on  prevention  and
control of human disease. In addition, the future financing needs of the Centre for the
period after n+2 will be decided in the light of this evaluation. The evaluation will
take  into  account  the  views  of  the  stakeholders,  at  both  Community  and  national
level.

■  The  Management  Board  of  the  Centre  shall  examine  the  conclusions  of  the
evaluation and issue to the Commission such recommendations as may be necessary
regarding  changes  in  the  Centre  and  its  working  practices.  The  evaluation  and  the
recommendations shall be made public.

8.

ANTI-FRAUD MEASURES

The Management Board is responsible for ensuring that its fraud prevention systems conform
to those of the Commission as set down in Article 25 of the Centre’s Regulation.

The staff assigned under the Commission’s Staff Regulations shall cooperate with OLAF in
combating fraud.

Article  23  provides  that  the  European  Court  of  Auditors  shall  examine  the  accounts  in
accordance with Article 248 of the Treaty.

48