Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 april 2004 establishing a European Centre for disease prevention and control
Date: 2004-04-21
Institutions: Council of the European Union, European Parliament
Subjects: EU office or agency, disease prevention, public health

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I

(Acts whose publication is obligatory)

REGULATION (EC) No 851/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 21 April 2004
establishing a European centre for disease prevention and control

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 152(4) thereof,

of the Council of 24 September 1998 setting up a network
for the epidemiological surveillance and control of com-
municable diseases in the Community (3), which requires
timely scientific analysis in order for effective Community
action to be undertaken.

Having regard to the proposal from the Commission,

(4)

Having regard to the opinion of the European Economic and
Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251
of the Treaty (2),

Whereas:

(1)

(2)

(3)

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 poten-
tial threats to health with a view to ensuring a high level of
protection of health of European citizens. Effective
response to disease outbreaks requires a coherent approach
among Member States and input from experienced public
health experts, coordinated at Community level.

The Community should address European citizens’ con-
cerns about public health threats in a coordinated and
coherent way. As the protection of health can mean vari-
ous actions ranging from preparedness and control mea-
sures to prevention of human diseases, the scope of actions
should be kept broad. The danger of deliberate release of
agents also requires a coherent Community response.

Member States must provide information on communi-
cable diseases through the appropriate designated struc-
tures and/or authorities, in accordance with Article 4 of
Decision No 2119/98/EC of the European Parliament and

(1) OJ C 32, 5.2.2004, p. 57.
(2) Opinion of the European Parliament of 10 February 2004 (not yet
published in the Official Journal) and decision of the Council of 30
March 2004.

Decision No 2119/98/EC expressly calls for the improve-
ment of the coverage and effectiveness of existing dedi-
cated 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 competent
in the field of public health, and in particular to pursue
closer collaboration with the World Health Organisation
(WHO). The Centre for Disease Prevention and Control
should therefore establish clear procedures for cooperation
with the WHO.

(5)

An independent agency, named the European Centre for
Disease Prevention and Control should serve as a Commu-
nity source of independent scientific advice, assistance and
expertise from trained medical, scientific and epidemio-
logical staff from its own resources or from those of rec-
ognised competent bodies acting on behalf of Member
States’ authorities responsible for human health.

(6)

This Regulation does not confer any regulatory powers on
the Centre.

(7)

The Centre’s mission should be to identify, assess and com-
municate current and emerging threats to human health
from communicable diseases. In the case of outbreaks of
illness of unknown origin which may spread within or to
the Community, the Centre should be empowered to act
on its own initiative until the source of the outbreak is
known and then in cooperation with the relevant compe-
tent authorities at national or Community level as
appropriate.

(8)

In this way, the Centre will enhance the capacity of the sci-
entific expertise in the European Community and support

(3) OJ L 268, 3.10.1998, p. 1. Decision as last amended by Regulation

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

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Community preparedness planning. It should support
existing activities, such as relevant Community action pro-
grammes in the public health sector, with regard to the
prevention and control of communicable diseases, epide-
miological surveillance, training programmes and early
warning and response mechanisms, and should foster the
exchange of best practices and experience with regard to
vaccination programmes.

representatives of competent bodies in the Member States
which undertake tasks similar to those of the Centre and
representatives of interested parties at European level, such
as non-governmental organisations, professional bodies or
academia. The Advisory Forum constitutes a mechanism
for an exchange of information on potential risks and the
pooling of knowledge and for monitoring the scientific
excellence and independence of the Centre’s work.

(9)

As emerging health threats may have mental as well as
physical health consequences, the Centre should in the
fields within its mission gather and analyse data and infor-
mation on emerging public health threats and develop-
ments for the purpose of protecting public health in the
European Community by preparedness. It should assist
and coordinate with Member States in developing and
maintaining the capacity to react in a timely way. In pub-
lic health emergencies the Centre should operate in close
collaboration with Commission services and other agen-
cies, Member States and international organisations.

(10) The Centre should seek to maintain scientific excellence at
all times through its own expertise and the expertise in the
Member States and should foster, develop and steer applied
scientific studies. In this way, it will enhance the visibility
and credibility of scientific expertise in the Community.
Moreover, it will support Community preparedness plan-
ning, strengthening links with and between the clinical and
public health sectors, reinforcing the public health labora-
tory capacity for rapid diagnosis and supporting and coor-
dinating training programmes.

(14) 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 sci-
entific quality, transparency and efficiency.

(15) The independence of the Centre and its role in informing
the public mean that it should be able to communicate on
its own initiative in the fields within its mission, its pur-
pose being to provide objective, reliable and easily under-
standable information to improve citizens’ confidence.

(16) The Centre should be financed by the general budget of the
European Union, without prejudice to the priorities agreed
by the budgetary authority within the financial perspective.
The Community budgetary procedure remains applicable
as regards any subsidies chargeable to the general budget
of the European Union and their annual evaluation. More-
over, the Court of Auditors should undertake the auditing
of accounts.

(11) The Management Board should be selected in such a way
as to secure the highest standards of competence and a
broad range of relevant experience available amongst the
representatives of the Member States, the European Parlia-
ment and the Commission.

(17)

It is necessary to allow for the participation of 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.

(12) The Management Board should have the necessary powers
to establish the budget, check its implementation, draw up
internal rules, ensure coherence with Community policies,
adopt the Centre’s financial regulation in accordance with
the provisions of the Financial Regulation applicable to the
general budget of the European Communities (1), herein-
after referred to as the ‘Financial Regulation’, and appoint
the director following a parliamentary hearing of the
selected candidate.

(18) An independent external evaluation should be undertaken
to assess the impact of the Centre on the prevention and
control of human disease and the possible need to extend
the scope of
the Centre’s mission to other relevant
Community-level activities in public health, in particular to
health monitoring.

(13) An advisory forum should advise the director in the per-
formance of his/her duties. It should be composed of

(1) Council Regulation (EC, Euratom) No 1605/2002 (OJ L 248,

16.9.2002, p. 1).

(19) 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 Commis-
sion and the Member States will avoid duplication of effort.
This should be done in an open and transparent fashion
and the Centre should take into account Community
expertise, structures and agencies already in place,

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HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1.
This Regulation establishes an independent European
agency for disease prevention and control, its mission, tasks and
organisation.

2.
The Agency shall be named the European Centre for Dis-
ease Prevention and Control, hereinafter referred to as the ‘Centre’.

Article 2

Definitions

For the purposes of this Regulation:

(a)

(b)

(c)

‘competent body’ shall mean any structure, institute, agent or
other scientific body recognised by Member States authori-
ties as providing independent scientific and technical advice
or capacity for action in the field of the prevention and con-
trol 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 disease;

“dedicated surveillance network” shall mean any specific net-
work on diseases or special health issues selected for epide-
miological surveillance between accredited structures and
authorities of the Member States;

2000/57/EC of
specified in Commission Decision
22 December 1999 on the early warning and response sys-
tem for the prevention and control of communicable diseases
under Decision No 2119/98/EC of the European Parliament
and of the Council (1).

Article 3

Mission and tasks of the Centre

In order to enhance the capacity of the Community and the
1.
Member States to protect human health through the prevention
and control of human disease, the mission of the Centre shall be
to identify, assess and communicate current and emerging threats
to human health from communicable diseases. In the case of other
outbreaks of illness of unknown origin which may spread within
or to the Community, the Centre shall act on its own initiative
until the source of the outbreak is known. In the case of an out-
break which clearly is not caused by a communicable disease, the
Centre shall act only in cooperation with the competent author-
ity upon request from that authority. In pursuing its mission the
Centre shall take full account of the responsibilities of the Mem-
ber States, the Commission and other Community agencies, and
of the responsibilities of international organisations active within
the field of public health, in order to ensure comprehensiveness,
coherence and complementarity of action.

2. Within the field of its mission, the Centre shall:

(a)

search for, collect, collate, evaluate and disseminate relevant
scientific and technical data;

(b) provide scientific opinions and scientific and technical assis-

tance including training;

(d)

“communicable diseases” shall mean the categories of disease
listed in the Annex to Decision No 2119/98/EC;

(c) provide timely information to the Commission, the Member
States, Community agencies and international organisations
active within the field of public health;

(e)

“health threat” shall mean a condition, agent or incident
which may cause, directly or indirectly, ill health;

(f)

“epidemiological
ascribed to it in Decision No 2119/98/EC.

surveillance”

shall have the meaning

(d) coordinate the European networking of bodies operating in
the fields within the Centre’s mission, including networks
arising from public health activities supported by the Com-
mission and operating the dedicated surveillance networks;

(g)

“Community network” shall have the meaning ascribed to it
in Decision No 2119/98/EC;

and

(h)

“early warning and response system” shall mean the network
in accordance with Decision No 2119/98/EC for the preven-
tion and control of communicable diseases, formed by bring-
ing the Commission and the competent public health
authorities in each Member State into permanent communi-
through appropriate means
cation with one another

(e)

exchange information, expertise and best practices, and facili-
tate the development and implementation of joint actions.

(1) OJ L 21, 26.1.2000, p. 32.

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The Centre, the Commission and the Member States shall
3.
cooperate to promote effective coherence between their respec-
tive activities.

identification and characterisation of infectious agents which may
threaten public health. The Centre shall maintain and extend such
cooperation and support the implementation of quality assurance
schemes.

Article 4

Obligations of the Member States

Member States shall:

(a) provide to the Centre in a timely manner available scientific

and technical data relevant to its mission;

(b) communicate to the Centre any messages forwarded to the
Community network via the early warning and response
system;

and

(c)

identify, within the field of operation of the mission of the
Centre, recognised competent bodies and public health
experts who could be made available to assist in Community
responses to health threats, such as field investigations in the
event of disease clusters or outbreaks.

CHAPTER 2

OPERATIONAL PROCEDURES

Article 5

4.
The Centre shall cooperate with the competent bodies rec-
ognised by the Member States, particularly on preparatory work
for scientific opinions, scientific and technical assistance, collec-
tion of data and identification of emerging health threats.

Article 6

Scientific opinions and studies

The Centre shall provide independent scientific opinions,

1.
expert advice, data and information.

2.
The Centre shall seek to maintain scientific excellence at all
times through the best expertise available. Where independent sci-
entific expertise is not available from existing dedicated surveil-
lance networks, the Centre may set up independent ad hoc scien-
tific panels.

The Centre may promote and initiate scientific studies nec-
3.
essary for the performance of its mission and applied scientific
studies and projects on the feasibility, development and prepara-
tion of its activities. The Centre shall avoid duplication with Mem-
ber States’ or Community research programmes.

Operation of dedicated surveillance networks and
networking activities

4.
The Centre shall consult the Commission with regard to the
planning and priority setting of research and public health studies.

1.
The Centre, through the operation of the dedicated surveil-
lance networks and the provision of technical and scientific exper-
tise to the Commission and Member States, shall support the net-
working activities of the competent bodies recognised by the
Member States.

2.
The Centre shall ensure the integrated operation of dedi-
cated surveillance networks of authorities and structures desig-
nated under Decision No 2119/98/EC, where necessary with the
assistance of one or more of the surveillance networks. It shall in
particular:

Article 7

Procedure for scientific opinions

1.

The Centre shall issue a scientific opinion:

(a) at the request of the Commission, in respect of any matter
within its mission, and in all cases where Community legis-
lation makes provision for the Centre to be consulted;

(a) provide quality assurance by monitoring and evaluating sur-
veillance activities of such dedicated surveillance networks to
ensure optimal operation;

(b) at the request of the European Parliament or a Member State,

on matters falling within its mission;

(b) maintain

the

database(s)

for

such

epidemiological

and

surveillance;

(c)

communicate the results of the analysis of data to the Com-
munity network; and

(d) harmonise and rationalise the operating methodologies.

(c) on its own initiative, on matters falling within its mission.

Requests referred to in paragraph 1 shall be accompanied by
2.
background information explaining the scientific issue to be
addressed and the Community interest.

3.
By encouraging cooperation between expert and reference
laboratories, the Centre shall foster the development of sufficient
capacity within the Community for the diagnosis, detection,

The Centre shall issue scientific opinions within a mutually

3.
agreed time frame.

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4. 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.

and coordinating investigation teams. The Centre shall respond
within its financial capacity and mandate.

3.
Requests for scientific or technical assistance to the Centre
shall be accompanied by a set deadline which must be agreed with
the Centre.

5. Where the Centre has already delivered a scientific opinion
on the specific topic in a request and it concludes that there are
no scientific elements justifying the re-examination, information
supporting that conclusion shall be given to the institution or
Member State(s) that made the request.

In the event of such a request for assistance from the Com-
4.
mission, a Member State, a third country or an international
organisation, where the financial capacity of the Centre is not
adequate to deal with that request, the Centre shall assess the
request and explore possibilities for response directly or through
other Community mechanisms.

6.
The Centre’s internal rules shall specify requirements regard-
ing the format, explanatory background and publication of a sci-
entific opinion.

5.
The Centre shall inform Member States authorities and the
Commission without delay, within the framework of the Commu-
nity network set up by Decision No 2119/98/EC, of any such
request and of its intentions.

Article 8

Operation of the early warning and response system

1.
The Centre shall support and assist the Commission by
operating the early warning and response system and by ensur-
ing with the Member States the capacity to respond in a coordi-
nated manner.

2.
The Centre shall analyse the content of messages received by
it via the early warning and response system. The Centre shall
provide information, expertise, advice and risk assessment. The
Centre shall also take action to ensure that the early warning and
response system is efficiently and effectively linked with other
Community alert systems (e.g. animal health, food and feed and
civil protection).

The Centre shall, as appropriate, support and coordinate
6.
training programmes in order to assist Member States and the
Commission to have sufficient numbers of trained specialists, in
particular in epidemiological surveillance and field investigations,
and to have a capability to define health measures to control dis-
ease outbreaks.

Article 10

Identification of emerging health threats

The Centre shall in the fields within its mission establish, in
1.
cooperation with the Member States, procedures for systemati-
cally searching for, collecting, collating and analysing information
and data with a view to the identification of emerging health
threats which may have mental as well as physical health conse-
quences and which could affect the Community.

Article 9

Scientific and technical assistance and training

2.
The Centre shall forward to the European Parliament, the
Council and the Commission an annual evaluation of the current
and emerging threats to health in the Community.

1.
The Centre shall provide scientific and technical expertise to
the Member States, the Commission and other Community agen-
cies in the development, regular review and updating of prepared-
ness plans, and also in the development of intervention strategies
in the fields within its mission.

3.
The Centre shall also inform the Commission and Member
States as soon as possible about findings which require their
immediate attention.

2.
The Centre may be requested by the Commission, the Mem-
ber States, third countries and international organisations (in par-
ticular the WHO) to provide scientific or technical assistance in
any field within its mission. Scientific and technical assistance
provided by the Centre shall be based on evidence-based science
and technology. Such assistance may include aiding the Commis-
sion and Member States to develop technical guidelines on good
practice and on protective measures to be taken in response to
human health threats, providing expert assistance and mobilising

Article 11

Collection and analysis of data

1.
The Centre shall coordinate data collection, validation,
analysis and dissemination of data at Community level, including
on vaccination strategies. The statistical element of this data col-
lection will be developed in collaboration with Member States
using, as necessary, the Community statistical programme, to pro-
mote synergy and avoid duplication.

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2.

For the purposes of paragraph 1, the Centre shall:

— develop with the competent bodies of the Member States and
the Commission appropriate procedures to facilitate consul-
tation and data transmission and access;

— carry out technical and scientific evaluation of prevention

and control measures at Community level;

and

— work in close cooperation with the competent bodies of the
organisations operating in the field of data collection from
the Community, third countries, the WHO, and other inter-
national organisations.

The Centre shall make available relevant information col-
3.
lected as referred to in paragraphs 1 and 2 to the Member States
in an objective, reliable and easily accessible way.

Article 12

Communications on the activities of the Centre

1.
The Centre shall communicate on its own initiative in the
fields within its mission, after having given prior information to
the Member States and to the Commission. It shall ensure that the
public and any interested parties are rapidly given objective, reli-
able and easily accessible information with regard to the results of
its work. In order to achieve these objectives, the Centre shall
make available information for the general public,
including
through a dedicated website. It shall also publish its opinions pro-
duced in accordance with Article 6.

2.
The Centre shall act in close collaboration with the Member
States and the Commission to promote the necessary coherence
in the risk communication process on health threats.

3.
The Centre shall cooperate as appropriate with the compe-
tent bodies in the Member States and other interested parties with
regard to public information campaigns.

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

The Management Board shall be composed of one member
1.
designated by each Member State, two members designated by the
European Parliament and three members representing and
appointed by the Commission.

2.
The members of the Board shall be appointed in such a way
as to secure the highest standards of competence and a broad
range of relevant expertise.

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

Members’ term of office shall be four years and can be extended.

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 invi-
tation of the Chair, or at the request of at least a third of its
members.

4.

The Management Board shall adopt its Rules of Procedure.

5.

The Management Board shall:

(a)

exercise disciplinary authority over the director and appoint
or dismiss him/her pursuant to Article 17;

(b) ensure that the Centre carries out its mission and performs
the tasks assigned to it under the conditions laid down in this
Regulation including on the basis of regular independent and
external evaluations to be carried out every five years;

(c)

compile a list of competent bodies referred to in Article 5 and
make it public;

(d) adopt, before 31 January each year, the Centre’s programme
of work for the coming year. It shall also adopt a revisable
multiannual programme. The Management Board shall
ensure that these programmes are consistent with the Com-
munity’s legislative and policy priorities in the area of its mis-
sion. Before 30 March each year, the Management Board shall
adopt the general report on the Centre’s activities for the pre-
vious year;

(e) 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

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23 December 2002 on the framework Financial Regulation
for the bodies referred to in Article 185 of Council Regula-
tion (EC, Euratom) No 1605/2002 on the Financial Regula-
tion applicable to the general budget of the European Com-
munities (1), unless specifically required for the Centre’s
operation and with the Commission’s prior consent;

(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) determine by unanimity of its members the rules governing
the languages of the Centre, including the possibility of a dis-
tinction between the internal workings of the Centre and the
external communication, taking into account the need to
ensure access to, and participation in, the work of the Centre
by all interested parties in both cases.

(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;

6.
The director shall take part in the meetings of the Manage-
ment Board, without voting rights, and shall provide the
secretariat.

Article 15

Voting

1.
The Management Board shall take its decisions by a simple
majority of all members. A two-thirds majority of all members
shall be required for the adoption of its Rules of Procedure, the
Centre’s internal rules of operation, the budget, the annual work
programme and the appointment and removal of the director.

(g) preparing the statement of revenue and expenditure and

executing the budget of the Centre;

(h) all staff matters, and in particular the exercise of powers laid

down in Article 29(2).

Each year, the director shall submit to the Management

3.
Board for approval:

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

in the previous year;

(b) draft work programmes;

Each of these members shall have one vote. The director of

2.
the Centre shall not vote.

(c)

the draft annual accounts for the previous year;

In the absence of a member, his/her alternate shall be

3.
entitled to exercise his/her right to vote.

(d)

the draft budget for the coming year.

4.
The Rules of Procedure shall establish the more detailed vot-
ing arrangements, in particular, the conditions for a member to
act on behalf of another member.

Article 16

Director

1.
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 Commis-
sion and the Management Board.

The director shall be the legal representative of the Centre

2.
and shall be responsible for:

(a)

the day-to-day administration of the Centre;

(b) drawing up draft work programmes;

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 informa-
tion relevant to the outcome of the evaluation procedures.

The director shall report on the Centre’s activities to the

5.
Management Board.

Article 17

Appointment of the director

1.
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 expres-
sions of interest, for a period of five years, which may be extended
once for a further period of up to five years.

(c) preparation of discussions within the Management Board;

(1) OJ L 357, 31.12.2002, p. 72.

2.
Before appointment, the candidate nominated by the Man-
agement Board shall be invited without delay to make a statement
before the European Parliament and to answer questions put by
members of that institution.

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Article 18

Advisory Forum

the Centre to cooperate in specific tasks and to take part in the rel-
evant activities of the Advisory Forum.

1.
The Advisory Forum shall be composed of members from
technically competent bodies in the Member States which under-
take tasks similar to those of the Centre, on the basis of one rep-
resentative designated by each Member State recognised for
his/her scientific competence, as well as three members without
the right to vote nominated by the Commission and representing
interested parties at European level, such as non-governmental
organisations representing patients, professional bodies or aca-
demia. Representatives may be replaced by alternates, appointed
at the same time.

CHAPTER 4

TRANSPARENCY AND CONFIDENTIALITY

Article 19

Declaration of interest

2. Members of the Advisory Forum shall not be members of
the Management Board.

The members of the Management Board, the members of
1.
the Advisory Forum, scientific panels and the director shall under-
take to act in the public interest.

The Advisory Forum shall support the director in ensuring
3.
the scientific excellence and independence of activities and opin-
ions of the Centre.

The Advisory Forum shall constitute a mechanism for an
4.
exchange of information on health threats 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)

in those circumstances where the Centre and a national body
cooperate;

(c)

the promoting, starting up and supervising of the European
networks within the fields of the Centre’s mission;

(d) where the Centre or a Member State identifies an emerging

public health threat;

(e)

the setting up of scientific panels by the Centre;

(f)

scientific and public health priorities to be addressed in the
work programme.

5.
The Advisory Forum shall be chaired by the director or, in
his/her absence, by a deputy from within the Centre. It shall meet
regularly at the invitation of the director, 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 inter-
nal rules and shall be made public.

Representatives of the Commission’s departments may par-

6.
ticipate in the work of the Advisory Forum.

7.
The Centre shall provide the technical and logistic support
necessary for the Advisory Forum and provide a secretariat for its
meetings.

8.
The director may invite experts or representatives of profes-
sional or scientific bodies, or non-governmental organisations
with recognised experience in disciplines related to the work of

The members of the Management Board, the director, the
2.
members of the Advisory Forum, as well as external experts par-
ticipating in scientific panels shall make a declaration of commit-
ment 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.

3.
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 prejudi-
cial 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
1.
and of the Council of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents (1)
shall apply to documents held by the Centre.

2.
The Management Board shall adopt the practical arrange-
ments for implementing Regulation (EC) No 1049/2001 within
six months of entry into force of this Regulation.

3.
Decisions taken by the Centre pursuant to Article 8 of Regu-
lation (EC) No 1049/2001 may give rise to the lodging of a com-
plaint to the Ombudsman or form the subject of an action before
the Court of Justice of the European Communities, under the con-
ditions laid down in Articles 195 and 230 of
the Treaty
respectively.

Personal data shall not be processed or communicated
4.
except in cases where this is strictly necessary for the fulfilment
of the mission of the Centre. In such cases, Regulation (EC)
No 45/2001 of the European Parliament and of the Council of

(1) OJ L 145, 31.5.2001, p. 43.

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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 data (1) shall apply.

Article 21

Confidentiality

1. Without prejudice to 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. Without prejudice to
Decision No 2119/98/EC, if the confidential information has been
submitted by a Member State, this information cannot be dis-
closed without the prior consent of that Member State.

2. 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.

3.
The conclusions of the scientific opinions delivered by the
Centre relating to foreseeable health effects shall on no account
be kept confidential.

4.
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

1.
Estimates of all the revenue and expenditure of the Centre
shall be prepared for each financial year, corresponding to the cal-
endar year, and shall be shown in the budget of the Centre.

The revenue and expenditure shown in the budget of the

2.
Centre shall be in balance.

The revenue of the Centre shall, without prejudice to other

3.
resources, comprise:

(d) any voluntary contribution from the Member States.

4.
The expenditure of the Centre shall include staff remunera-
tion, administrative and infrastructure costs, operating expenses
and expenses resulting from contracts entered into with the insti-
tutions or with third parties.

5.
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.

6.
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.

7.
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.

8.
The budgetary authority shall authorise the appropriations
for the subsidy to the Centre. The budgetary authority shall adopt
the establishment plan for the Centre.

9.
The budget of the Centre shall be adopted by the Manage-
ment 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 Com-
mission thereof.

Where a branch of the budgetary authority has notified its inten-
tion to deliver an opinion, it shall forward its opinion to the Man-
agement Board within a period of six weeks from the date of noti-
fication of the project.

Article 23

Implementation of the Centre’s budget

(a) a subsidy from the Community entered in the general bud-

get of the European Union (Commission section);

1.

The director shall implement the Centre’s budget.

(b) payments received for services rendered;

(c) any financial contributions from the competent bodies

referred to in Article 5;

(1) OJ L 8, 12.1.2001, p. 1.

By 1 March at the latest following each financial year, the
2.
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 finan-
cial year. The Commission’s accounting officer shall consolidate
the provisional accounts of the institutions and decentralised bod-
ies in accordance with Article 128 of the Financial Regulation.

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By 31 March at the latest following each financial year, the
3.
Commission’s accounting officer shall forward the Centre’s pro-
visional 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 Parlia-
ment and the Council.

On receipt of the Court of Auditors’ observations on the
4.
Centre’s provisional accounts, pursuant to Article 129 of the
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 Cen-

5.
tre’s final accounts.

6.
The director shall, by 1 July at the latest following each
financial year, forward the final accounts to the European Parlia-
ment, the Council, the Commission and the Court of Auditors,
together with the Management Board’s opinion.

7.

The final accounts shall be published.

The director shall send the Court of Auditors a reply to its
8.
observations by 30 September at the latest. He/she shall also send
this reply to the Management Board.

9.
The director shall submit to the European Parliament, at the
latter’s request, any information required for the smooth applica-
tion of the discharge procedure for the financial year in question,
as laid down in Article 146(3) of the 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 imple-
mentation of the budget for year N.

Article 24

Application of the Financial Regulation

Article 185 of the Financial Regulation shall apply to the dis-
charge of the Centre’s budget, its audits and accounting rules.

Article 25

Combating fraud

1.
In order to combat fraud, corruption and other unlawful
activities, the provisions of Regulation (EC) No 1073/1999 of the
European Parliament and of the Council of 25 May 1999 con-
cerning investigations conducted by the European Anti-fraud
Office (OLAF) (1) shall apply without restriction to the Centre.

The Centre shall accede to the Inter-institutional Agreement
2.
of 25 May 1999 concerning internal investigations by the Euro-
pean Anti-fraud Office (OLAF) (2) and shall issue, without delay,
the appropriate provisions applicable to all of its staff.

3.
The decisions concerning funding and the implementing
agreements and instruments resulting therefrom shall explicitly
stipulate that the Court of Auditors and OLAF may carry out, if
necessary, on-the-spot checks of the recipients of the Centre’s
funding and the agents responsible for allocating it.

CHAPTER 6

GENERAL PROVISIONS

Article 26

Legal personality and privileges

1.
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 immov-
able property and institute legal proceedings.

The Protocol on the privileges and immunities of the Euro-

2.
pean Communities shall apply to the Centre.

Article 27

Liability

1.
The contractual liability of the Centre shall be governed by
the law applicable to the contract in question. The Court of Jus-
tice of the European Communities shall have jurisdiction to give
judgment pursuant to any arbitration clause contained in a con-
tract concluded by the Centre.

2.
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 ser-
vants 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
3.
be governed by the relevant provisions applying to the staff of the
Centre.

Article 28

Examination of legality

1. Member States, members of the Management 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.

(1) OJ L 136, 31.5.1999, p. 1.

(2) OJ L 136, 31.5.1999, p. 15.

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Referral shall be made to the Commission within 15 days of
2.
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
3.
no decision has been taken within this period, the case shall be
deemed to have been dismissed.

4.
An action for annulment of the Commission’s explicit or
implicit decision referred to in paragraph 3 to reject the admin-
istrative appeal may be brought before the Court of Justice in
accordance with Article 230 of the Treaty.

Article 29

Staff

The staff of the Centre shall be subject to the rules and the
1.
regulations applicable to officials and other staff of the European
Communities.

In respect of its staff, the Centre shall exercise the powers

2.
which have been devolved to the appointing authority.

3.
Secondment to the Centre of public health experts, includ-
ing epidemiologists, for a defined period of time, for the achieve-
ment of certain specified tasks of the Centre will be encouraged
within the framework of existing regulations.

Article 30

Participation of third countries

1.
The Centre shall be open to the participation of countries,
which have concluded agreements with the Community by virtue
of which they have adopted and apply legislation of equivalent
effect to Community legislation in the field covered by this
Regulation.

2.
Arrangements shall be made under the relevant provisions
of those agreements, specifying in particular the nature, extent
and manner in which these countries are to participate in the Cen-
tre’s work, including provisions relating to participation in the
networks operated by the Centre, inclusion in the list of compe-
tent organisations to which certain tasks may be entrusted by the
Centre, financial contributions and staff.

CHAPTER 7

FINAL PROVISIONS

Article 31

Review clause

1.
By 20 May 2007, the Centre shall commission an indepen-
dent external evaluation of its achievements on the basis of terms
of reference issued by the Management Board in agreement with
the Commission. The evaluation shall assess:

(a)

the possible need to extend the scope of the Centre’s mission
to other relevant Community-level activities in the field of
public health, in particular to health monitoring;

and

(b)

the timing of further such reviews.

This assessment shall take into account the tasks of the Centre, the
working practices and the impact of the Centre on the prevention
and control of human disease, and shall include an analysis of the
synergy effects and the financial implications of such an exten-
sion. The evaluation shall take into account the views of the stake-
holders, at both Community and national level.

The Management Board shall examine the conclusions of
2.
the evaluation and issue to the Commission such recommenda-
tions as may be necessary regarding changes in the Centre, its
working practices and the scope of its mission. The Commission
shall forward the evaluation report and the recommendations to
the European Parliament and the Council and make them public.
After assessment of the evaluation report and the recommenda-
tions, the Commission may submit any proposals for amend-
ments to this Regulation which it deems necessary.

Article 32

Commencement of the Centre’s operation

The Centre shall be operational by 20 May 2005.

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.

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

Done at Strasbourg, 21 April 2004.

For the EuropeanParliament
P.COX
The President

For the Council
D. ROCHE
The President