Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control
Date: 2020-11-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Centre for Disease Prevention and Control, coronavirus disease, cross-border cooperation, disease prevention, epidemic, epidemiology, health control, health risk

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   EUROPEAN COMMISSION  Brussels, 11.11.2020  COM(2020) 726 final 2020/0320 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

As  a  building  block  of  the  European  Health  Union,  this  proposal  reinforces  the 
mandate  of  the  European  Centre  for  Disease  Prevention  and  Control  (‘the  Centre’) 
addressing  surveillance,  preparedness,  early  warning  and  response  under  a 
strengthened EU health security framework. The COVID-19 pandemic has revealed 
shortcomings  in  Union  mechanisms  for  managing  health  threats,  which  call  for  a 
more structured Union-level approach, which is also built on the European value of 
solidarity, to future health crises. This should include a reinforced role for the Centre. 
It should also take a One-Health approach, together with other relevant EU Agencies, 
to  the  issue,  considering  the  interactions  between  humans,  animals  and  the 
environment. 

The Centre’s mandate, established by Regulation (EC) No 851/2004 of the European 
Parliament  and  of  the  Council1,  was  adopted  before  the  mechanisms  and  structures 
under  the  current  EU  health  security  framework  under  Decision  1082/2013/EU  on 
serious cross-border threats to health2. 

Given  the  review  of  this  framework,  the  Centre’s  founding  regulation  needs  to  be 
amended, to ensure consistency with other Union instruments and with the proposal 
for an amending Regulation on serious cross-border threats to health. The review will 
also  ensure  that  the  Centre  fully  complies  with  the  ‘common  approach’  for 
decentralised  agencies,  as  laid  down  in  the  ‘Joint  Statement  of  the  European 
Parliament,  the  Council  of  the  EU  and  the  European  Commission  on  decentralized 
agencies’3. 

• 

Consistency with existing Union measures in this field 

The proposal is part of a package of closely associated measures, and forms part of 
the  Union’s  overall  health  response  to  COVID-19  as  well  as  an  improved  crisis 
management framework.  

The  amendments  proposed  will  therefore  be  in  compliance  with  the  ‘common 
approach’ for decentralised agencies, from 2012.  

• 

Consistency with other Union policies 

This proposal is in line with the Union’s overarching objectives, including a stronger 
health Union, a smooth functioning of the single market,  complementarity  with  the 
Union Civil Protection Mechanism, sustainable and resilient health systems, and an 
ambitious research and innovation agenda. In addition, it will provide useful input to 
and  synergies  with  the  EU  Digital  Single  Market  agenda  and  the  future  European 
Health  Data  Space,  encouraging  innovation  and  research,  facilitating  information 
sharing (including of real-time data), and supporting the development of EU-level IT 
infrastructure for epidemiological surveillance and monitoring.  

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3 

OJ L 142, 30.4.2004, p. 1 
OJ L 293, 5.11.2013, p. 1 
https://europa.eu/european-
union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf 

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2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The proposed Regulation is based on Article 168(5) of the Treaty on the Functioning 
of the European Union (TFEU). This approach is based on the specific objectives of 
the proposal, namely to adopt measures to protect and improve human health and in 
particular  combating  major  cross-border  health 
through 
monitoring and early warning. 

threats,  especially 

• 

Subsidiarity (for non-exclusive competence)  

Although  the  Member  States  are  responsible  for  managing  public  health  crises  at 
national level, no country can tackle a cross-border public health crisis alone. Under 
Article  2(5)  TFEU,  the  Union  has  competence  to  carry  out  measures  to  support, 
coordinate  or  supplement  actions  by  Member  States,  without  thereby  superseding 
their competence in this area. 

threats 

transnational 
to  health  have,  by 
Serious  cross-border 
implications. In a globalised society, people and goods are moving across borders in 
high  numbers,  facilitating  illnesses  and  contaminated  products  to  circulate  rapidly 
across  the  globe.  Public  health  measures  at  national  level  therefore  need  to  be 
consistent  with  each  other  and  be  coordinated  to  contain  any  further  spread  and 
minimise the consequences of these threats. 

their  nature, 

Public  health  emergencies  of  the  magnitude  of  COVID-19  have  an  impact  on  all 
Member  States.  The  proposal  builds  on  lessons learnt  during  the  COVID-19  crisis, 
and  proposes  to  strengthen  the  existing  Union  level  structures  and  mechanisms  for 
improved  levels  of  protection,  prevention,  preparedness  and  response,  against  all 
health hazards across the EU. 

Since  the  objectives  of  this  Regulation  cannot  be  sufficiently  achieved  by  the 
Member States alone due to the cross-border dimension of the threats described and 
can, therefore, be better achieved at Union level, the Union may adopt measures, in 
accordance with the principle of subsidiarity as set out in Article 5(3) of the Treaty 
on European Union (TEU). 

• 

Proportionality 

The  proposal  constitutes  a  proportionate  and  necessary  response  to  the  problems 
described in section 1. In accordance with the principle of proportionality, as set out 
in Article 5(4) TEU, this Regulation does not go beyond what is necessary to achieve 
those objectives. 

• 

Choice of the instrument 

The proposal takes the form of an amendment of the existing Regulation. This type 
of  instrument  is  considered  most  suitable,  considering  that  a  key  element  of  the 
proposal  is  to  establish  well-aligned  procedures  and  structures  for  joint  work  at 
Union level, focussing on giving additional tasks to the Centre. The measures do not 
require the implementation of national measures and can be directly applicable.  

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3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

As part of a package of urgent measures based on lessons learnt so far from COVID-
19,  the  initiative  is  supported  by  the  findings  of  the  recent  evaluation  of  the 
functioning of the Centre4, by an assessment of data collected and by exchanges held 
with  public  and  private  stakeholders  on  issues  encountered  during  the  COVID-19 
pandemic and possible means to address them. Due consideration is given also to the 
findings of the Court of Auditors’ Report on the EU health security framework5. This 
information  is  summarised  in  the  Commission  Communication  accompanying  the 
whole  package.  Considering  that  the  initiative  proposes  to  enlarge  the  scope  of 
existing  legislation,  it  will  not  be  based  on  an  ex-post  evaluation,  as  the  needs 
identified where not addressed by the existing framework. 

It  is  proposed  that  the  Commission  will  report,  by  2023,  on  the  Centre’s  activities, 
including  an  analysis  of  how  the  amended  mandate  has  been  implemented,  the 
interaction and consistency of the Centre’s activities with the proposed Regulation on 
serious  cross-border  threats  to  health,  and,  by  2028,  possible  amendments  to  the 
mandate of the Centre. This will also include an analysis of the Centre’s relevance in 
relation  to  international,  Union  and  national  health  priorities,  as  well  as  the 
relationship between the Centre’s outputs and Member States’ capacities. This report 
will be accompanied by a study, commissioned by the Commission. Moreover, every 
five  years  the  Commission  will  evaluate  the  Centre's  performance  in  relation  to  its 
objectives, mandate, tasks, procedure and location, in accordance with Commission 
Better Regulation guidelines. 

• 

Stakeholder consultations 

At the informal Health Council meeting on 16 July 2020, Germany’s Presidency of 
the Council of the EU chaired a discussion about strengthening the Centre. Member 
States showed support for an initiative directed at doing so as part of the overall EU 
health  crisis  preparedness  and  response  mechanism.  This  implies  an  amendment  of 
the  Centre’s  founding  Regulation.  The  informal  Health  Council  Working  Party  on 
Public  Health  on  29  October  2020  further  discussed  draft  Council  conclusions  on 
COVID-19  lessons  learnt  in  health.  Bilateral  meetings  at  political  and  technical 
levels  were  further  held,  and  a  public  webinar  was  organized  on  29  October  to 
discuss the package.  

• 

Impact assessment 

Due  to  its  urgent  nature,  this  proposal  is  not  accompanied  by  a  formal  impact 
assessment.  Instead,  the  changes  are  mainly  based  on  an  assessment  of  the  data 
collected  during  the  first  months  of  the  pandemic  and  exchanges  with  public  and 
private  stakeholders  on  COVID-19  issues  and  possible  means  to  address  them  and 
are  based  on  the  findings  of  a  recent  evaluation.  This  information  has  been 
summarised in a Commission Communication that accompanies the overall package 
of  proposals  providing  or  referring  to  all  available  evidence,  given  that  a  public 
consultation  and  an  impact  assessment  could  not  be  delivered  in  the  timeframe 
available prior to the adoption of this proposal.  

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5 

https://www.ecdc.europa.eu/en/publications-data/third-external-evaluation-ecdc-2013-2017 
https://www.eca.europa.eu/en/Pages/DocItem.aspx?did=40126 

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• 

Fundamental rights 

The proposal contributes to achieving a high level of human, gender-sensitive, health 
protection, as well as to upholding the highest standards in the protection of human 
rights  and  civil  liberties,  as  enshrined  in  the  Charter  of  Fundamental  Rights  and  in 
the  European  Pillar  of  Social  Rights,  during  health  crisis.  Where  personal  data  is 
processed under this Regulation as proposed, it will be done in accordance with the 
relevant Union legislation on personal data protection, in particular Regulation (EU) 
2018/1725 and Regulation (EU) 2016/679.  

4. 

BUDGETARY IMPLICATIONS 

The  implementation  of  this  proposal  has  no  impact  on  the  current  Multiannual 
Financial Framework 2014-2020.  

The  financial  impact  of  this  proposal  on  the  Union  budget  will  be  part  of  the  next 
Multiannual Financial Framework 2021-2027.  

The budgetary implications are mainly related to the following objectives: 

● 

● 

● 

setting-up  a  new  vaccine  monitoring  platform  hosted  jointly  by  the  European 
Medicines Agency and the Centre; 

preparedness  and 
anticipation, monitoring and assessment;  

response  planning  activities 

including  modelling, 

new  networks  on  Union 
transplantation and medically assisted reproduction;  

reference 

laboratories  and  on 

transfusion, 

● 

reinforcing surveillance systems and the Early Warning and Response System;  

●  monitoring  and  assessing  health  systems  capacity  and  identifying  population 
groups at risk and in need of targeted prevention and response measures 

● 

● 

creating  a  ‘EU  Health  Task  Force’  to  support  countries  with  preparedness 
strengthening and quickly intervene in a health crisis; 

improving  international  collaboration  and  gathering  of  regional/national 
intelligence. 

5. 

• 

OTHER ELEMENTS 

Detailed explanation of the specific provisions of the proposal 

The  proposal  aims  to  provide  reinforced  capacities  of  the  Centre,  to  support 
preparedness, surveillance, risk assessment, and early warning and response to face 
future cross-border health threats.  

Key areas of the proposal: 

● 

● 

● 

situational awareness: rapid digitalisation of integrated surveillance systems;  

better preparedness in Member States: develop prevention and response plans 
against future epidemics and stronger capacities for integrated rapid epidemic 
and outbreak response; 

reinforced  measures  to  control  epidemics  and  outbreaks:  provision  of  non-
binding recommendations for risk management; 

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● 

● 

● 

● 

● 

● 

● 

expanded capacity to mobilise and deploy the EU Health Task Force to assist 
the response in Member States; 

reinforced capacity and building key competences to monitor and assess health 
systems  capacity  for  diagnosis,  prevention  and 
treatment  of  specific 
communicable diseases as well as patient safety; 

reinforced  capacity  and  to  identify  population  groups  at  risk  and  in  need  of 
targeted prevention and response measures; 

linking  research  and  preparedness  and  response:  liaise  between  public  health 
and research communities, contribute to  defining research priorities related to 
preparedness  and  response,  ensure  integration  of  research  findings  in  policy 
recommendations; 

building  up  the  key  competences  for  health  protection  in  Member  States:  the 
Centre  will  be  tasked  with  coordinating  a  new  network  of  Union  reference 
laboratories  for  public  health  and  a  new  network  of  national  services 
supporting transfusion, transplantation and medically assisted reproduction; 

expanding  work  on  the  prevention  of  communicable  diseases  and  specific 
health issues, e.g., antimicrobial resistance, vaccination and biosecurity; 

reinforcing  the  contribution  to  the  EU’s  international  cooperation  and 
development and EU commitment to global health security preparedness. 

The proposal  will also  seek to  ensure  smooth  cooperation during such emergencies 
between the Centre and the EU’s other decentralised agencies, most notably with the 
European Medicines Agency.  
This  proposal  is  aligned  with  the  Common  Approach6  regarding  structure  and 
governance, its operations, programming and accountability. 

6 

Joint  Statement  and  Common  Approach 
https://europa.eu/european-
union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf 

(Parliament,  Council  &  Commission),  2012; 

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2020/0320 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EC) No 851/2004 establishing a European Centre for disease 
prevention and control 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 168(5) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee7,  
Having regard to the opinion of the Committee of the Regions8,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

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8 
9 

The Union is committed to protect and improve human health, in particular to combat 
the  major  cross-border  health  scourges,  measures  concerning  monitoring,  early 
warning of and combating serious cross-border threats to health.  
Regulation  (EC)  No  851/2004  of  the  European  Parliament  and  of  the  Council9 
established  an  independent  European  agency  –  the  European  Centre  for  Disease 
Prevention  and  Control  (the  ‘Centre’)  with  the  mission  to  identify,  assess  and 
communicate  current  and  emerging  threats  to  human  health  from  communicable 
diseases.  

On  11  March  2020,  the  World  Health  Organization  (WHO)  declared  the  novel 
coronavirus COVID-19 outbreak a global pandemic. From the challenges experienced 
in  responding  to  the  pandemic  it  became  clear  that  the  Centre’s  role  in  the  Union’s 
framework for health crisis preparedness and response should be strengthened.  

A  joint  opinion  issued  by  The  European  Commission’s  Group  of  Chief  Scientific 
Advisors, the European Group on Ethics in Science and New Technologies , and the 
Special  Advisor  to  the  President  of  the  European  Commission  on  the  response  to 
COVID-19 recommends ‘establishing a standing EU advisory body for health threats 
and crises‘. 

This Regulation accordingly expands the mission and tasks of the Centre to  enhance 
the Centre’s capacity to provide the required scientific expertise and to support actions 
which are relevant to the prevention, preparedness, response planning and combating 

OJ C , , , p. . 
OJ C , , , p. . 
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 (OJ L 142, 30.4.2004, p. 1). 

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(6) 

(7) 

(8) 

serious cross-border threats to health in the Union in accordance with Regulation EU 
…/… of the European Parliament and of the Council10 [ISC/2020/12524].  

In  this  respect,  the  Centre  should  be  tasked  with  providing  epidemiological 
information and its analysis, epidemiological modelling, anticipation and forecasting, 
relevant risk assessments and recommendations, which set out options for prevention 
and  control  of  communicable  diseases.  Its  actions  should  be  consistent  with  a  One-
Health approach, recognising the interconnections  between human and animal  health 
and the environment. It should monitor the capacity of the national health systems to 
respond  to  communicable  disease  threats,  in  particular  given  the  importance  of  this 
information  in  the  preparation  of  the  national  preparedness  and  response  plans.  The 
Centre  should  support  the  implementation  of  actions  funded  by  the  relevant  Union 
funding  programmes  and  instruments  and  related  to  communicable  diseases,  provide 
guidelines for treatment and case management based on a thorough assessment of the 
latest evidence, support epidemic and outbreak responses in Member States and third 
countries,  including  field  response,  and  provide  timely  objective,  reliable  and  easily 
accessible  information  on  communicable  diseases  to  the  public.  The  Centre  should 
also  establish  clear  procedures  for  cooperation  with  the  public  health  actors  in  third 
countries, as well as international organisations competent in the field of public health 
hence  contributing  to  EU’s  commitment  to  reinforcing  partners’  preparedness  and 
response capacity. 

To effectively support the work of the Centre and ensure the fulfilment of its mission, 
Member States should be tasked to communicate to the Centre data on the surveillance 
of  communicable  diseases  and  other  special  health  issues  such  as  antimicrobial 
resistance  and  healthcare-associated  infections  related  to  communicable  diseases, 
available  scientific  and  technical  data  and  information  relevant  to  the  Centre’s 
mission, to notify the Centre of any serious cross-border threats to health, information 
on  preparedness  and  response  planning  and  health  system  capacity,  and  provide 
relevant  information  that  may  be  useful  for  coordinating  the  response,  as  well  as 
identify  recognised  competent  bodies  and  public  health  experts  available  to  assist  in 
Union responses to health threats. 

To enhance preparedness and response planning activities in the Union, the Centre’s 
operation  of  dedicated  networks  and  networking  activities  should  be  broadened  to 
reflect the scope of Regulation (EU) …/…. [OJ: please, insert reference to Regulation 
SCBTH  [ISC/2020/12524]].  To  this  end,  the  Centre  should  coordinate  and  provide 
technical  and  scientific  expertise  to  the  Commission  and  Member  States  through 
dedicated networks with  competent  coordinating bodies, including newly established 
networks for laboratories and for supporting transfusion, transplantation and medically 
assisted reproduction, 

(9)  With  a  view  to  enhance  the  effectiveness  of  epidemiological  surveillance  of 
communicable  diseases  and  of  the  related  special  health  issues  in  the  Union,  the 
Centre  should  be  tasked  with  the  further  development  of  digital  platforms  and 
applications, supporting epidemiological surveillance at Union level, enabling the use 
of digital technologies, such as artificial intelligence, in the compilation and analysis 
of data, and providing Member States with technical and scientific advice to establish 

10 

Regulation  (EU)  XXXX/XXXX  of  the  European  Parliament  and  of  the  Council  of  DATE  on  serious 
cross-border threats to health and repealing Decision No 1082/2013/EU [OJ: please, insert full title and 
publication reference to Regulation on serious cross border threats to health (SCBTH).] 

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integrated  epidemiological  surveillance  systems.  Such  digital  platforms  and 
applications  should  be  developed  with  integrated  EU  space  generated  data  with  the 
intention to be integrate them in the future European Health Data Space as governed 
by the Union legislation. 

(10)  To  strengthen  the  capacity  of  the  Union  and  Member  States  to  assess  the 
epidemiological  situation  and  perform  accurate  risk  assessment  and  response,  the 
Centre  should  in  particular  monitor  and  report  on  trends  in  communicable  diseases, 
support  and  facilitate  evidence-based  response  action,  provide  recommendations  for 
improvement  of  communicable  disease  prevention  and  control  programmes 
established at the national and Union level, monitor and assess the capacity of national 
health  systems  for  diagnosis,  prevention  and  treatment  of  communicable  diseases, 
including  in  a  gender-sensitive  way,  identify  population  groups  at  risk  requiring 
specific  measures,  analyse  the  correlation  of  disease  incidence  with  societal  and 
environmental factors, and identify risk factors for transmission and disease severity of 
communicable diseases, and identify research needs and priorities. The Centre should 
work  with  nominated  national  focal  points  for  surveillance,  forming  a  network  that 
strategically  advises  the  Centre  on  such  matters  and  would  promote  the  use  of 
enabling sectors, such as EU space data and services. 

(11)  The Centre should help strengthen the capacity within the Union to  diagnose, detect, 
identify  and  characterise  infectious  agents  which  may  threaten  public  health  by 
ensuring  the  operation  of  the  network  of  Union  reference  laboratories  in  accordance 
with  Regulation  (EU)  …/…  [OJ:  please,  insert  reference  to  Regulation  SCBTH 
[ISC/2020/12524]].  This  network  is  responsible  for  the  promotion  of  good  practice 
and  alignment  on  diagnostics,  testing  methods,  and  use  of  tests,  in  order  to  ensure 
uniform  surveillance,  notification  and  reporting  of  diseases,  as  well  as  strengthened 
quality of testing and surveillance.  

(12)  Where  in  case  of  cross-border  health  threats  posed  by  communicable  diseases,  the 
blood  and  transplant  services  in  the  Member  States  can  provide  a  means  for  rapid 
testing  of  the  donor  population  and  assessing  exposure  to  and  immunity  from  the 
disease  in  the  general  population.  These  services  are  dependent  on  rapid  risk 
assessments by the Centre to safeguard patients in need of a therapy from a substance 
of  human  origin  from  the  transmission  of  such  a  communicable  disease.  Such  risk 
assessments serve as the basis for appropriate adaptation of measures setting standards 
for quality and safety of the substances of human origin. The Centre should therefore 
establish  and  operate  a  network  of  national  blood  and  transplant  services  and  their 
authorities to serve this purpose.  

(13)  With the aim of reducing the occurrence of epidemics and strengthening capacities to 
prevent communicable diseases in the Union, the Centre should develop a framework 
for the prevention of communicable diseases, which addresses such issues as vaccine 
preventable  diseases,  antimicrobial  resistance,  health  education,  health  literacy  and 
behaviour change.  

(14)  The  Centre  should  enhance  preparedness  and  response  capabilities  at  national  and 
Union level by providing scientific and technical expertise to the Member States and 
the  Commission.  In  this  context  the  Centre,  in  close  collaboration  with  the  Member 
States  and  the  Commission,  should  carry  out  various  actions,  including  the 
development of Union and national preparedness and response plans and preparedness 
monitoring  and  evaluation  frameworks,  provide  recommendations  on  capacities  to 
prevent, prepare and respond to disease outbreaks and on the strengthening of national 

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health systems. The Centre should broaden its collection and analysis of data in terms 
of  epidemiological  surveillance  and  related  special  health  issues,  progression  of 
epidemic situations, unusual epidemic phenomena or new diseases of unknown origin, 
including in third countries, molecular pathogen data and health systems data. To this 
end,  the  Centre  should  ensure  appropriate  datasets  as  well  as  the  procedures  to 
facilitate  consultation  and  data  transmission  and  access,  carry  out  scientific  and 
technical evaluation of prevention and control measures at Union level and work with 
agencies, competent bodies and organisations operating in the field of data collection.  

(15)  Regulation  …/… 

reference 

[OJ:  please, 

to  Regulation  SCBTH 
insert 
[ISC/2020/12524]]  provides  for  the  early  warning  and  response  system  enabling  the 
notification  at  Union  level  of  alerts  related  to  serious  cross-border  threats  to  health 
which continues to be operated by the ECDC. Given that modern technologies can be 
of substantial support to combat health threats  and  to contain and reverse epidemics, 
the  ECDC  should  work  on  updating  this  system  to  enable  the  use  of  artificial 
intelligence technologies and interoperable  and privacy-preserving digital tools, such 
as mobile applications, with tracing functionalities identifying at-risk individuals. 

(16)  The  Centre  should  establish  appropriate  capacities  to  support  international  and  field 
response,  in  accordance  with  Regulation  …/…  [OJ:  please,  insert  reference  to 
Regulation  SCBTH  [ISC/2020/12524]].  These  capacities  should  enable  the  Centre  to 
mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’, to 
assist  local  responses  to  outbreaks  of  diseases.  The  Centre  should  therefore  ensure 
capacity  to  carry  out  missions  to  Member  States  as  well  as  in  third  countries  and  to 
provide recommendations on response to health threats. These teams will also be able 
to  be  deployed  under  the  Union  Civil  Protection  Mechanism  with  the  support  of  the 
Emergency  Response  Coordination  Centre.  The  Centre  should  also  support  the 
strengthening  of  preparedness  capacities  under  the  International  Health  Regulations 
(IHR) in third countries, in order to address serious cross border threats to health and 
the consequences thereof. 

(17)  To assist responses to outbreaks, which may spread within or to the Union, the Centre 
is  to  develop  a  framework  for  the  mobilisation  the  EU  Health  Task  Force  in 
accordance  with  Decision  No  1313/2013/EU  of  the  European  Parliament  and  of  the 
Council11  and  facilitate  the  participation  of  Union  field  response  experts  in 
international response teams in support of the Union Civil Protection Mechanism. The 
Centre  should  enhance  the  capability  of  its  staff  as  well  as  experts  from  Union  and 
EEA  countries,  candidate  countries  and  potential  candidates,  as  well  as  European 
Neighbourhood Policy countries and EU partner countries as referred to in Regulation 
(EU)  No  233/2014  of  the  European  Parliament  and  of  the  Council12,  to  effectively 
participate in field missions and crisis management. 

(18) 

In order to assess the effectiveness and efficiency of the legal provisions applicable to 
the  Centre,  it  is  appropriate  to  provide  for  a  regular  Commission  evaluation  of  the 
performance of the Centre.  

(19)  This Regulation should not confer any regulatory powers on the Centre. 

11 

12 

Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a 
Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924). 
Regulation  (EU)  No  233/2014  of  the  European  Parliament  and  of  the  Council  of  11  March  2014 
establishing  a  financing  instrument  for  development  cooperation  for  the  period  2014-2020  (OJ  L  77, 
15.3.2014, p. 44). 

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(20)  The Centre should implement an information system capable of exchanging classified 
and  sensitive  non-classified  information  to  ensure  that  such  information  is  managed 
with the utmost discretion. 

(21) 

In  view  of  the  urgency  entailed  by  the  exceptional  circumstances  caused  by  the 
COVID-19 pandemic, it is considered to be appropriate to provide for an exception to 
the eight-week period referred to in Article 4 of Protocol No 1 on the role of national 
Parliaments in the European Union, annexed to the Treaty on European Union, to the 
Treaty  on  the  Functioning  of  the  European  Union  and  to  the  Treaty  establishing  the 
European Atomic Energy Community. 

(22)  Since the objectives of this Regulation to expand the mission and tasks of the Centre 
in  order  to  enhance  the  Centre’s  capacity  to  provide  the  required  scientific  expertise 
and  to  support  actions  which  combat  serious  cross-border  threats  to  health  in  the 
Union cannot be sufficiently achieved by the Member States but can rather, by reason 
of the cross-border nature of the health threats and the need for rapid, coordinated and 
coherent  response,  be  achieved  at  Union  level,  the  Union  may  adopt  measures,  in 
accordance  with  the  principle  of  subsidiarity  as  set  out  in  Article  5  of  the  Treaty  on 
European Union. In accordance with the principle of proportionality as set out in that 
Article, this Regulation does not go beyond what is necessary in order to achieve those 
objectives. 

(23)  Regulation (EC) No 851/2004 should therefore be amended, 

HAVE ADOPTED THIS REGULATION: 

Regulation (EC) No 851/2004 is amended as follows: 

(1) 

Article 2 is replaced by the following: 

Article 1 

‘ 

Article 2 

Definitions 

For the purposes of this Regulation, the following definitions apply: 

(1) 

(2) 

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

‘coordinating  competent  body’  means  a  body  in  each  Member  State  with  a 
designated  national  coordinator  responsible  for  institutional  contacts  with  the 
Centre,  as  well  as  national  focal  points  and  operational  contact  points 
responsible  for  strategic  and  operational  collaboration  on  technical  and 
scientific issues for specific diseases areas and public health functions;  

(3) 

‘dedicated  network’  means  any  specific  network  on  diseases,  special  health 
issues  or  public  health  functions  to  ensure  collaboration  between  the 
coordinating competent bodies of the Member States;  

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(4) 

(5) 

(6) 

‘communicable  disease’  means  communicable  disease  as  defined  in  point  (2) 
of  Article  3  of  Regulation  (EU)  …/…  [OJ:  Please  insert  the  number  of 
Regulation SCBTH [ISC/2020/12524]]; 

‘serious  cross-border  threat  to  health’  means  serious  cross-border  threat  to 
health as defined in point (7) of Article 3 of Regulation (EU) …/… [OJ: Please 
insert the number of Regulation SCBTH [ISC/2020/12524]]; 

‘epidemiological  surveillance’  means  epidemiological  surveillance  as  defined 
in  point  (4)  of  Article  3  of  Regulation  (EU)  …/…  [OJ:  Please  insert  the 
number of Regulation SCBTH [ISC/2020/12524]]. ’; 

(2) 

Article 3 is replaced by the following:  

‘Article 3 

Missions and tasks of the Centre 

1. 

In order to enhance the capacity of the Union and the Member States to protect 
human health through the prevention and control of communicable diseases in 
humans  and  those  related  special  health  issues  set  out  in  Article  2  of 
Regulation  (EU)  …/…  [OJ:  Please  insert  the  number  of  Regulation  SCBTH 
[ISC/2020/12524]],  the  mission  of  the  Centre  shall  be  to  identify,  assess  and 
report  on  current  and  emerging  threats  to  human  health  from  communicable 
diseases,  and  provide  recommendations  for  response  at  Union  and  national 
levels, as well as at regional level, if necessary.  

In the case of other outbreaks of illnesses of unknown origin that may spread 
within or to the Union, the Centre shall act on its own initiative until the source 
of the outbreak is known. In the case of an outbreak that clearly is not caused 
by  a communicable  disease, the Centre shall  act  only in  cooperation with the 
competent body upon request from that body.  

In pursuing its mission, the Centre shall take full account of the responsibilities 
of  the  Member  States,  the  Commission  and  other  Union  bodies  or  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. 

The  Centre  shall,  within  its  financial  capacity  and  mandate,  perform  the 
following tasks:  

(a) 

search  for,  collect,  collate,  evaluate  and  disseminate  relevant  scientific 
and technical data and information, considering the latest technologies; 

assessments, 

(b)  provide  analyses,  scientific  advice,  opinions  and  support  for  actions  by 
the  Union  and  Member  States  on  cross-border  health  threats,  including 
risk 
information, 
of 
epidemiological  modelling,  anticipation  and  forecast,  recommendations 
for actions to prevent and control communicable disease threats and other 
special  health  issues,  contribution  to  defining  research  priorities,  and 
scientific and technical  assistance including training  and other activities 
within its mandate; 

epidemiological 

analysis 

(c) 

coordinate  the  European  networking  of  bodies  operating  in  the  fields 
within  the  Centre’s  mission,  including  networks  arising  from  public 

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health  activities  supported  by  the  Commission  and  operating  the 
dedicated networks; 

(d) 

exchange information, expertise and best practice;  

(e)  monitor  health  systems’  capacity  relevant  to  the  management  of 

communicable disease threats and other special health issues; 

(f) 

facilitate  the  development  and  implementation  of  actions,  funded  by 
relevant  Union  funding  programmes  and  instruments,  including  the 
implementation of joint actions; 

(g)  provide,  upon  request  of  the  Commission  or  the  HSC,  or  its  own 
initiative,  guidelines 
treatment  and  case  management  of 
communicable diseases and other special health issues relevant for public 
health, in cooperation with relevant societies; 

for 

(h) 

(i) 

(j) 

support epidemic and outbreak response in  Member States, and in  third 
countries,  in  complementarity  with  other  Union  emergency  response 
instruments, in particular the Union Civil protection mechanism;  

contribute  to  strengthening  preparedness  capacities  under  the  IHR  in 
third countries, in particular EU partner countries; 

provide,  upon  request  of  the  Commission  or  the  Health  Security 
Committee  (‘HSC’),  evidence-based  communication  messages  to  the 
public on communicable diseases, on the threats to health posed by them 
and on the relevant prevention and control measures. 

3. 

The Centre, the Commission, the relevant Union bodies or EU agencies and the 
Member  States  shall  cooperate  to  promote  effective  coherence  between  their 
respective activities.’; 

(3) 

Article 4 is replaced by the following: 

‘Article 4 

Obligations of the Member States 

Member States shall: 

(a) 

communicate  to  the  Centre  in  a  timely  manner  and  according  to  agreed  case 
definitions,  indicators,  standards,  protocols  and  procedures  data  on  the 
surveillance  of  communicable  diseases  and  other  special  health  issues 
undertaken  in  accordance  with  Article  13  of  Regulation  (EU)  …/…  [OJ: 
Please  insert  the  number  of  Regulation  SCBTH  [ISC/2020/12524]],  and 
available scientific and technical data and information relevant to the Centre’s 
mission,  including  on  preparedness,  and  health  systems  capacities  to  detect, 
prevent, respond to and recover from outbreaks of communicable diseases;  

(b)  notify  the  Centre  of  any  serious  cross-border  threats  to  health,  as  soon  as 
detected,  through  the  Early  Warning  and  Response  System  (EWRS),  and 
promptly  communicate  response  measures  taken,  as  well  as  any  relevant 
information that may be useful for coordinating the response as referred to in 
Article  21  of  Regulation  (EU)  …/…  [OJ:  Please  insert  the  number  of 
Regulation SCBTH [ISC/2020/12524]]; and  

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(c) 

identify, within the scope of the mission of the  Centre, recognised competent 
bodies  and  public  health  experts  who  could  be  made  available  to  assist  in 
Union responses to health threats, such as by undertaking missions to Member 
States to provide expert advice and field investigations in the event of disease 
clusters or outbreaks.’; 

(4) 

Article 5 is replaced by the following: 

‘Article 5 

Operation of dedicated networks and networking activities 

1. 

2. 

The  Centre  shall  support  the  networking  activities  of  the  competent  bodies 
recognised  by  the  Member  States  through  the  provision  of  coordination  and 
technical  and  scientific  expertise  to  the  Commission  and  Member  States  and 
through the operation of the dedicated networks. 

The  Centre  shall  ensure  the  integrated  operation  of  the  network  for  the 
epidemiological  surveillance of the communicable diseases and of the related 
special health issues referred to in points (i) and (ii) of point (a) of Article 2(1) 
of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH 
[ISC/2020/12524]]. 

It shall in particular: 

(a) 

ensure the further development of the digital platforms and applications 
supporting  epidemiological  surveillance  at  Union  level,  supporting 
Member States with technical and scientific advice to establish integrated 
surveillance  systems  enabling  real-time  surveillance  where  appropriate, 
benefiting from existing EU space infrastructures and services;  

(b)  provide quality assurance by monitoring and evaluating epidemiological 
surveillance  activities  (including  setting  surveillance  standards  and 
monitoring data completeness) of the dedicated surveillance networks to 
ensure optimal operation; 

(c)  maintain  database(s)  for  such  epidemiological  surveillance,  coordinate 
with the hosts of other relevant databases, and work towards harmonised 
approaches to data collection and modelling; 

(d) 

(e) 

(f) 

(g) 

communicate  the  results  of  the  analysis  of  data  to  the  Commission  and 
Member States;  

harmonise and rationalise the operating methodologies; 

ensure  the  interoperability  of  automated  applications,  including  for 
contact tracing, developed at national level;  

ensure  the  interoperability  of  the  digital  platforms  for  surveillance  with 
digital  infrastructures  allowing  for  the  health  data  to  be  used  for 
healthcare,  research,  policy  making  and  regulatory  purposes  and  with  a 
view  to  integrate  those  platforms  and  infrastructures  in  the  European 
Health  Data  Space,  as  regulated  by  Union  legislation,  and  make  use  of 
other relevant data, for example environmental factors. 

3. 

The  Centre  shall  support  the  work  of  the  HSC,  the  Council  and  other  Union 
structures  for  coordinating  responses  to  serious  cross-border  threats  to  health 
within its mandate. 

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4. 

The  Centre,  through  the  operation  of  the  network  for  the  epidemiological 
surveillance, shall: 

(a)  monitor  and  report  on  trends  in  communicable  diseases  over  time  and 
across Member States and in third countries, based on agreed indicators, 
to  assess  the  present  situation  and  facilitate  appropriate  evidence-based 
action, 
identification  of  specifications  for 
through 
harmonised data collection from member states  

including 

the 

(b)  detect, monitor and report on serious cross-border threats to health in the 
case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1) 
of  Regulation  (EU)  …/…  [OJ:  Please  insert  the  number  of  Regulation 
SCBTH  [ISC/2020/12524]],  including  a  threat  to  substances  of  human 
origin,  such  as  blood,  organs,  tissues  and  cells  potentially  impacted  by 
communicable diseases, or in point (d) of Article 2(1) of that Regulation, 
with  respect  to  source,  time,  population  and  place  in  order  to  provide a 
rationale for public health action; 

(c) 

contribute  to  the  evaluation  and  monitoring  of  communicable  disease 
prevention and control programmes in order to provide the evidence for 
recommendations  to  strengthen  and  improve  these  programmes  at  the 
national and Union levels;  

(d)  monitor and assess health systems’ capacity for diagnosis, prevention and 

treatment of specific communicable diseases as well as patients’ safety; 

(e) 

(f) 

(g) 

(h) 

identify population groups at risk and in need of targeted prevention and 
response  measures,  and  ensure  that  those  measures  are  accessible  for 
persons with disabilities;  

contribute to the assessment of the burden of communicable diseases on 
the  population  using  data,  such  as  disease  prevalence,  complications, 
hospitalisation  and  mortality,  and  ensure  that  this  data  is  disaggregated 
on age, gender and disability;  

carry  out  epidemiological  modelling,  anticipation  and  scenario 
development  for  response  and  coordinate  such  efforts  with  a  view  to 
exchange  best  practices  and  improve  modelling  capacity  across  the 
Union; and  

identify  risk  factors  for  disease  transmission,  groups  most  at  risk, 
including  the  correlation  of  disease  incidence  and  severity  with  societal 
and environmental factors, and research priorities and needs. 

5. 

Each  Member  State  shall  designate  a  coordinating  competent  body  and 
nominate  a  national  focal  point  and  operational  contact  points  as  relevant  for 
public health functions, including epidemiological surveillance, and for various 
disease groups and individual diseases.  

The  national  focal  points  shall  form  networks  that  strategically  advise  the 
Centre.  

National  focal  points  and  operational  contact  points  nominated  for  disease-
specific  interactions  with  the  Centre  shall  form  disease-specific  or  disease-
group-specific networks whose tasks shall include the transmission of national 
surveillance data to the Centre.  

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6. 

7. 

8. 

9. 

Member  States  shall  notify  the  Centre  and  other  Member  States  of  the 
designations and nominations provided for in this paragraph and of any change 
thereof. 

The  Centre  shall  ensure  the  operation  of  the  network  of  EU  reference 
laboratories  referred  to  in  Article  15  of  Regulation  (EU)  …/…  [OJ:  Please 
insert the number of Regulation SCBTH [ISC/2020/12524]], for the diagnosis, 
detection,  identification  and  characterisation  of  infectious  agents  that  may 
present a threat to public health.  

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

The Centre shall ensure the operation of the network of Member State services 
supporting  transfusion,  transplantation  and  medically  assisted  reproduction  to 
allow  for  continuous  and  rapid  access  to  sero-epidemiological  data  via  sero-
epidemiological surveys within the population, including assessment of donor 
population exposure and immunity.  

The  network  referred  to  in  the  first  subparagraph  shall  support  the  Centre  by 
monitoring  disease  outbreaks  that  are  relevant  to  substances  of  human  origin 
and their supply to patients, and with the development of guidelines for blood, 
tissues and cells safety and quality.  

The  Centre  shall  cooperate  with  the  competent  bodies  recognised  by  the 
Member  States,  particularly  on  preparatory  work  for  scientific  opinions, 
scientific and technical assistance, the collection of comparable data based on 
common formats that allows for ease of aggregation, and the identification of 
emerging health threats.’ 

(5) 

the following Article 5a is inserted: 

‘Article 5a 

Prevention of communicable diseases 

1. 

2. 

3. 

4. 

The  Centre  shall  support  Member  States  to  strengthen  their  communicable 
disease prevention and control systems.  

The  Centre  shall  develop  a  framework  for  the  prevention  of  communicable 
diseases  and  special 
including  vaccine  preventable  diseases, 
antimicrobial  resistance,  health  education,  health  literacy  and  behaviour 
change.  

issues, 

The  Centre  shall  evaluate  and  monitor  communicable  disease  prevention  and 
control programmes in  order to  provide the  evidence  for  recommendations to 
strengthen and improve these programmes at the national and Union level, and 
where appropriate at the international levels. 

The Centre shall coordinate independent post-marketing vaccines effectiveness 
and  safety  monitoring  studies  collecting  new  information  and/or  using  the 
relevant  data  collected  by  competent  bodies.  That  work  shall  be  conducted 

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jointly with the European Medicines Agency and notably though a new vaccine 
monitoring platform.’; 

(6) 

the following Article 5b is inserted: 

‘Article 5b 

Preparedness and response planning 

1. 

The  Centre  shall  provide  scientific  and  technical  expertise  to  the  Member 
States  and  the  Commission  in  collaboration  with  relevant  Union  bodies  and 
agencies  and  international  organisations  in  accordance  with  appropriate 
working  arrangements  established  with  the  Commission  in  the  field  of 
preparedness and response planning. 

The  Centre  shall,  in  close  collaboration  with  the  Member  States  and  the 
Commission:  

(a) 

to 

the  development,  regular  review  and  updating  of 
contribute 
preparedness  plans  and  blueprints  of  threat-specific  preparedness  plans 
for adoption by the HSC; 

(b)  develop  preparedness  monitoring  and  evaluation  frameworks  and 

indicators for preparedness; 

(c) 

(d) 

(e) 

(f) 

facilitate  self-assessments  and  external  evaluation  of  Member  States’ 
preparedness  and  response  planning,  and  contribute  to  reporting  and 
auditing on preparedness and response planning under Articles 7 and 8 of 
Regulation  (EU)  …/…  [OJ:  Please  insert  the  number  of  Regulation 
SCBTH [ISC/2020/12524]]; 

ensure monitoring of preparedness gaps and provision of targeted support 
to EU Member States and third countries in case of needs;  

develop  exercises,  in-action  and  after-action  reviews  and  organise 
capacity building actions to address identified preparedness capacity and 
capability gaps;  

develop  specific  preparedness  activities  addressing  vaccine  preventable 
diseases, antimicrobial resistance, laboratory capacity and biosecurity in 
accordance with Commission priorities and based upon gaps identified; 

(g) 

support the integration of research preparedness in the preparedness and 
response plans; 

(h)  develop  targeted  activities  addressing  at-risk  groups  and  community 

preparedness;  

(i) 

assess health systems’ capacity to detect, prevent, respond to and recover 
from  outbreaks  of  communicable  diseases,  identify  gaps  and  provide 
recommendations  for  the  strengthening  of  health  systems,  to  be 
implemented with Union support as appropriate; 

(j) 

bolster modelling, anticipation and forecast capacity of the Centre; and  

(k)  maintain  a  regular  secondment  mechanisms  between  the  Centre,  the 

Commission and Member States’ experts.’; 

(7) 

Article 6 is amended as follows: 

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(a) 

the following paragraph 1a is inserted:  

‘1a.  The  Centre  shall  provide  concrete  analyses  and  recommendations  for 
actions to prevent and control communicable disease threats upon request 
of the Commission.’; 

(b)  paragraph 3 is replaced by the following: 

‘3.  The Centre may promote and initiate scientific studies necessary for the 
performance of its mission and applied scientific studies and projects on 
the feasibility, development and preparation of its activities. The Centre 
shall  avoid  duplication  with  Commission’s,  Member  States’  and  Union 
research  and  health  programmes,  and  will  liaise  between  the  public 
health and the research sector as needed. 

To carry out the studies referred to in the first paragraph, the Centre shall 
have  access  to  health  data  made  available  or  exchanged  through  digital 
infrastructures and applications, in accordance with data protection rules, 
allowing  for  the  health  data  to  be  used  for  healthcare,  research,  policy 
making  and  regulatory  purposes.  For  the  purposes  of  studies  under  the 
first paragraph, the Centre shall also make use of other relevant data, for 
example on environmental and socio-economic factors.’; 

(c) 

paragraph 4 is replaced by the following:  

‘4.  The Centre shall consult with the Commission and other Union bodies or 
agencies with regard to the planning and priority setting of research and 
public health studies.’; 

(8) 

Article 7 is replaced by the following:  

‘Article 7 

Procedure for scientific opinions 

1. 

The Centre shall issue a scientific opinion on matters falling within its mission: 

(a) 

in  all  cases  where  Union  legislation  provides  that  the  Centre  is  to  be 
consulted; 

(b) 

at the request of the European Parliament or a Member State;  

(c) 

at the request of the Commission; and 

(d)  on its own initiative. 

2. 

Requests for a scientific opinion referred to in paragraph 1 shall clearly explain 
the scientific issue to be addressed and the Union interest and be accompanied 
by sufficient background information regarding that issue. 

3. 

The Centre shall issue scientific opinions within a mutually agreed time frame. 

4.  Where different requests are made on the same issue or where the request does 
not  comply  with  paragraph  2,  the  Centre  may  decline  to  issue  a  scientific 
opinion  or  propose  amendments  to  that  request  in  consultation  with  the 
institution  or  Member  State  that  made  the  request.  In  case  the  request  is 
declined, a justification shall be given to the institution or Member States that 
made the request.  

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5.  Where  the  Centre  has  already  delivered  a  scientific  opinion  on  the  specific 
issue covered by a request and it concludes that no scientific elements justify 
the re-examination of the issue, information supporting that conclusion shall be 
given to the institution or Member State that made the request. 

6. 

The  Centre’s  internal  rules  shall  specify  requirements  regarding  the  format, 
explanatory background and publication of a scientific opinion.’; 

(9) 

Article 8 is replaced by the following: 

‘Article 8 

Operation of the Early Warning and Response System 

1. 

The  Centre  shall  support  and  assist  the  Commission  by  operating  the  EWRS 
and  by  ensuring  with  the  Member  States  the  capacity  to  respond  in  a 
coordinated manner. 

2. 

The Centre shall: 

(a) 

analyse the content of messages received by it via the EWRS; 

(b)  provide  information,  expertise,  advice  and  risk  assessment  to  Member 

States and the Commission; and 

(c) 

ensure  that  the  EWRS  is  efficiently  and  effectively  linked  with  other 
Union alert systems. 

The  Centre  shall  work  with  the  Commission  and  the  HSC  on  the  EWRS 
updates,  including  for  the  use  of  modern  technologies,  such  as  digital  mobile 
applications, artificial intelligence models, or other technologies for automated 
contact  tracing,  building  upon  the  contact  tracing  technologies  developed  by 
the Member States and on defining the functional requirements of the EWRS. 

The  Centre  shall  work  with  the  Commission,  the  HSC  and  the  eHealth 
Network  to  further  define  the  functional  requirements  for  contact  tracing 
applications  and 
into  account  existing 
infrastructures  and  services,  such  as  geolocation  services  provided  by  EU 
Space Programme. 

interoperability, 

taking 

their 

The Centre as processor shall have the responsibility to ensure the security and 
confidentiality of the processing operations of personal data carried out within 
the EWRS and in the context of interoperability of contact tracing applications, 
in  accordance  with  the  obligations  laid  down  in  Articles  33,  34(2)  and  36  of 
Regulation (EU) 2018/1725 of the European Parliament and of the Council*  

3. 

4. 

5. 

________________ 

* 

Regulation (EU) 2018/1725 of the European Parliament and of the Council of 
23  October  2018  on  the  protection  of  natural  persons  with  regard  to  the 
processing  of  personal  data  by  the  Union  institutions,  bodies,  offices  and 
agencies  and  on  the  free  movement  of  such  data,  and  repealing  Regulation 
(EC)  No  45/2001  and  Decision  No  1247/2002/EC  (OJ  L  295,  21.11.2018,  p. 
39).’; 

(10) 

the following Article 8a is inserted: 

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‘Article 8a 

Risk assessment 

1. 

2. 

3. 

The  Centre  shall  provide  timely  rapid  risk  assessments,  in  accordance  with 
Article  20  of  Regulation  (EU)  …/…  [OJ:  Please  insert  the  number  of 
Regulation  SCBTH  [ISC/2020/12524]],  in  the  case  of  a  threat  referred  to  in 
points  (i)  and  (ii)  of  point  (a)  of  Article  2(1)  of  that  Regulation  including  a 
threat  to  substances  of  human  origin,  such  as  blood,  organs,  tissues  and  cells 
potentially impacted by communicable diseases, or point (d) of Article 2(1) of 
that Regulation 

The  risk  assessment  shall  include  general  and  targeted  recommendations  for 
response as a basis for coordination in the HSC.  

For the purposes of paragraph 1, the Centre shall coordinate the preparation of 
rapid  risk  assessments  by  involving  Member  States  experts  and  relevant 
agencies, if necessary. 

4.  Where  the  risk  assessment  falls  outside  the  mandate  of  the  Centre,  at  the 
request  of  the  agency  or  body  carrying  out  the  risk  assessment  within  its 
mandate,  the  Centre  shall,  without  undue  delay,  provide  it  with  any  relevant 
information and data that is at its disposal.’; 

(11) 

the following Article 8b is inserted: 

‘Article 8b 

Response coordination 

1. 

The  Centre  shall  support  response  coordination  in  the  HSC  as  referred  to  in 
Article  21  of  Regulation  (EU)  …/…  [OJ:  Please  insert  the  number  of 
Regulation  SCBTH 
in  particular  by  providing 
recommendations for response measures for:  

[ISC/2020/12524]], 

(a) 

(b) 

national responses to the serious cross-border threat to health; 

adoption  of  guidance  for  the  Member  States  for  the  prevention  and 
control of a serious cross-border threat to health. 

2. 

The  Centre  shall  support  a  Union  coordinated  response  at  the  request  of  a 
Member State, Council, Commission, Union bodies or agencies.’;  

(12) 

Article 9 is amended as follows: 

(a) 

paragraphs 1, 2 and 3 are replaced by the following: 

‘1.  The Centre shall provide scientific and technical expertise to the Member 
States,  the  Commission  and  other  Union  bodies  or  agencies  in  the 
development, regular review and updating of preparedness plans, and in 
the development of intervention strategies within the scope of its mission. 

2. 

The  Centre  may  be  requested  by  the  Commission,  the  Member  States, 
third  countries,  in  particular  EU  partner  countries,  and  international 
organisations  (in  particular  the  WHO)  to  provide  scientific  or  technical 
assistance in any field within the scope of its mission. The assistance may 
include aiding the Commission 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, mobilising 

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and coordinating investigation teams. The Centre shall provide scientific 
and  technical  expertise  and  assistance  within  its  financial  capacity  and 
mandate,  and  in  accordance  with  the  appropriate  working  arrangements 
established with the Commission. 

3. 

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

(b)  paragraph 5 is deleted.;  

(c) 

paragraph 6 is replaced by the following: 

‘6.  The  Centre  shall,  as  appropriate,  support  and  coordinate  training 
field 
programmes, 
investigations, preparedness and prevention, and public health research.’; 

in  epidemiological  surveillance, 

in  particular 

(13) 

Article 11 is amended as follows: 

(a) 

paragraph 1 is replaced by the following: 

‘1.  The  Centre  shall  coordinate  data  collection,  validation,  analysis  and 

dissemination of data at Union level.’;  

(b) 

the following paragraph 1a is inserted: 

‘1a.  The  Centre  shall  collect  data  and  information,  and  will  ensure  links  to 

relevant research data and outputs on: 

(a) 

(b) 

(c) 

epidemiological surveillance of communicable diseases and related 
special health issues referred to in points (i) and (ii) of point (a) of 
Article  2(1)  of  Regulation  (EU)  …/…  [OJ:  Please  insert  the 
number of Regulation SCBTH [ISC/2020/12524]]; 

the  progression  of  epidemic  situations,  including  for  modelling, 
anticipation and scenario development; 

unusual  epidemic  phenomena  or  new  communicable  diseases  of 
unknown origin, including those in third countries; 

(d)  molecular pathogen data, if required for detecting or investigating 

cross-border health threats; and 

(e) 

health  systems  data  required  for  managing  cross-border  health 
threats.’; 

(c) 

paragraph 2 is replaced by the following:  

‘2.  For the purposes of paragraph 1, the Centre shall: 

(a) 

develop, together with the competent bodies of the Member States 
facilitate 
and 
consultation and data transmission and access; 

the  Commission,  appropriate  procedures 

to 

(b) 

carry  out  technical  and  scientific  evaluation  of  prevention  and 
control measures at Union level; 

(c)  work  in  close  cooperation  with  the  competent  bodies  of  the 
organisations  operating  in  the  field  of  data  collection  from  the 
international 
Union, 
organisations; and 

the  WHO,  and  other 

third  countries, 

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(d)  develop  solutions  to  access  relevant  health data made available or 
exchanged  through  digital  infrastructures,  in  accordance  with  data 
protection  rules,  allowing  for  the  health  data  to  be  used  for 
healthcare,  research,  policy  making  and  regulatory  purposes;  and 
provide  and  facilitate  controlled  access  to  health  data  to  support 
public health research.’; 

(d) 

the following paragraphs 4 and 5 are added: 

‘4. 

5. 

In  the  situations  of  urgency  related  to  severity  or  novelty  of  a  serious 
cross-border  threat  to  health  or  to  the  rapidity  of  its  spread  among  the 
Member  States,  the  Centre  shall  make  available  epidemiological 
forecasts  as  referred  to  in  point  (g)  of  Article  5(4),  upon  request  of  the 
European  Medicines  Agency,  in  an  objective,  reliable  and  easily 
accessible way and on the basis of the best available information. 

In  the  situations  of  urgency  related  to  severity  or  novelty  of  a  serious 
cross-border  threat  to  health  or  to  the  rapidity  of  its  spread  among  the 
Member  States,  the  Centre  shall  provide  data  and  relevant  analyses  on 
the basis of the best available information.’; 

(14) 

the following Article 11a is inserted: 

‘Article 11a 

Support to international and field response 

1. 

2. 

3. 

4. 

5. 

The Centre shall establish capacity to mobilise and deploy the EU Health Task 
Force  including  the  Centre’s  staff  and  experts  from  Member  States  and 
fellowship programmes, to assist local response to outbreaks of communicable 
diseases in Member States and in third countries.  

The  Centre  shall  develop  a  framework  and  establish  procedures  with  the 
Commission to mobilise the EU Health Task Force.  

The  Centre  shall  ensure  that  the  EU  Health  Task  Force  are  coordinated  and 
complementary  to  the  capacities  integrating  the  European  Medical  Corps  and 
other relevant capacities under the Union Civil Protection Mechanism.  

The  Centre  shall  develop  with  the  Commission  a  framework  for  the 
mobilisation of the EU Health Task Force, in view of action under Decision No 
1313/2013/EU*.  

The  Centre  shall  provide  contributions  of  Union  field  response  experts  in 
international  response  teams  mobilised  by  the  WHO  Health  Emergencies 
Programme mechanism and the Global Outbreak Alert and Response Network 
in  accordance  with  appropriate  working  arrangements 
(GOARN)  and 
established with the Commission.  

The  Centre  shall  facilitate  the  development  of  field  response  capabilities  and 
crisis management expertise among the Centre’s staff and experts from EU and 
EEA  countries,  EU  candidate  countries  and  potential  candidates,  as  well  as 
European Neighbourhood Policy and EU partner countries, upon request of the 
Commission. 

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6. 

The  Centre  shall  maintain  capacity  to  carry  out  missions  to  Member  States, 
to  provide 
upon 
recommendations on response to threats to health within its mandate. 

the  Commission  and  Member  States, 

request  of 

7.  Upon request of the Commission and Member States, the Centre shall engage 
in  long  term  capacity  building  projects  aiming  to  strengthen  preparedness 
capacities under the IHR in non-European third countries, in particular partner 
countries. 

_______________ 

* 

Decision No 1313/2013/EU of the European Parliament and of the Council of 
17  December  2013  on  a  Union  Civil  Protection  Mechanism  (OJ  L  347, 
20.12.2013, p. 924).’; 

(15) 

Article 12 is amended as follows: 

(a) 

paragraph 1 is replaced by the following: 

‘1.  The  Centre  shall  communicate  on  its  own  initiative  within  the  scope  of 
its  mission,  after  having  given  prior  information  to  the  Member  States 
and to the Commission.  

The Centre shall ensure that the public or any interested party is rapidly 
given  objective, 
reliable,  evidence-based  and  easily  accessible 
information with regard to the results of its work. The Centre shall make 
available  information  for  the  general  public,  including  through  a 
dedicated  website  It  shall  also  publish  its  opinions  produced  in 
accordance with Article 6.’; 

(b)  paragraph 2 is deleted; 

(c) 

paragraph 3 is replaced by the following: 

‘3.  The  Centre  shall  cooperate  as  appropriate  with  the  competent  bodies  in 
the  Member  States  and  other  interested  parties  with  regard  to  public 
information campaigns.’; 

(16) 

Article 14 is amended as follows:  

(a) 

the third subparagraph of paragraph 2 is replaced by the following:  

‘Members’ term of office shall be three years and can be extended.’; 

(b) 

in paragraph 5, points (d), (e) and (f) are replaced by the following:  

‘(d)  adopt, before 31 January each year, the Centre’s programme of work for 

the coming year;  

(e) 

(f) 

adopt a draft single programming document in line with Article 32 of the 
Commission  Delegated  Regulation  (EU)  2019/715*  and  the  related 
Commission’s guidelines for the Single Programming Document**;  

ensure that the programme of work of the coming  year and multiannual 
programmes  are  consistent  with  the  Union’s  legislative  and  policy 
priorities  in  the  area  of  its  mission  and  tasks,  and  follow  the 
recommendations adopted in the annual Commission Opinion.  

(g)  before  30  March  each  year,  adopt  the  general  report  on  the  Centre’s 

activities for the previous year;  

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(h) 

(i) 

adopt  the  financial  rules  applicable  to  the  Centre  after  the  Commission 
has been consulted;  

determine the rules governing the languages of the Centre, including the 
possibility  of  a  distinction  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. 

The financial rules applicable to the Centre as referred to in point (h) of 
the  first  subparagraph  may  not  depart  from  Commission  Delegated 
Regulation  (EU)  2019/715,  unless  specifically  required  for  the  Centre’s 
operation and with the Commission’s prior consent. 

________________ 

* 

Commission Delegated Regulation (EU) 2019/715 of 18 December 
2018  on  the  framework  financial  regulation  for  the  bodies  set  up 
under the TFEU and Euratom Treaty and referred to in Article 70 
of  Regulation  (EU,  Euratom)  2018/1046  of 
the  European 
Parliament and of the Council (OJ L 122, 10.5.2019, p. 1).’; 

(17) 

point (b) of Article 16(2) is replaced by the following: 

‘(b)  drawing up draft work programmes  taking into account  the recommendations 
adopted  in  the  annual  Commission  Opinion  on  the  single  programming 
document;’ 

(18) 

Article 17 is replaced by the following: 

‘1.  Without  prejudice  to  Article  3(2),  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.’;  

(19) 

Article 18 is amended as follows: 

(a) 

paragraph 2 is replaced by the following: 

‘2.  Members  of  the  Advisory  Forum  shall  not  be  members  of  the 
Management  Board.  Members’  term  of  office  shall  be  three  years  and 
can be extended.’; 

(b) 

in paragraph 4, point (f) is replaced by the following: 

‘(f) 

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

(g)  key  publications  under  preparation  by  the  Centre  such  as  forecasting 

studies.’; 

(c) 

paragraph 8 is replaced by the following: 

‘8.  The  director  may  invite  experts  or  representatives  of  professional  or 
scientific  bodies,  or  non-governmental  organisations  with  recognised 
experience in disciplines related to the work of the Centre to cooperate in 
specific  tasks  and  to  take  part  in  the  relevant  activities  of  the  Advisory 
Forum. In addition, the Commission may suggest to the director experts 

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or  representatives  of  professional  or  scientific  bodies,  or  non-
governmental organizations to be invited on an ad-hoc basis.’; 

(20) 

paragraph 3 of Article 20 is replaced by the following:  

‘3.  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 Union 
(‘the Court of Justice’), under the conditions laid down in Articles 228 and 230 
TFEU respectively.’; 

(21) 

Article 21 is replaced by the following: 

‘Article 21 

Professional secrecy and 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.  If  the 
confidential  information  has  been  submitted  by  a  Member  State,  that 
information  cannot  be  disclosed  without  the  prior  consent  of  that  Member 
State. 

The  Commission’s  rules  on  security  regarding  the  protection  of  Union 
classified  information,  laid  down  in  Commission  Decisions  (EU,  Euratom) 
2015/443*  and  (EU,  Euratom)  2015/444**  shall  apply  to  the  work  of  the 
Centre and its staff. 

2.  Members  of  the  Management  Board,  the  director,  members  of  the  Advisory 
Forum,  as  well  as  external  experts  participating  in  the  scientific  panels,  and 
members of the staff of the Centre, even after their duties have ceased, shall be 
subject to the obligation of professional secrecy pursuant to Article 339 TFEU.  

3. 

4. 

5. 

6. 

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.  

The  Centre  shall  take  all  necessary  measures  to  facilitate  the  exchange  of 
information relevant to its tasks with the Commission, the Member States and, 
where appropriate, other Union institutions, and the Union bodies, offices and 
agencies and international organisations and third countries, in accordance with 
appropriate working arrangements established with the Commission.  

The Centre shall develop, deploy and operate an information system capable of 
exchanging  classified  and  sensitive  non-classified  information  as  specified  in 
this Article.  

__________________ 

* 

Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security 
in the Commission (OJ L 72, 17.3.2015, p. 41). 

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**  Commission  Decision  (EU,  Euratom)  2015/444  of  13  March  2015  on  the 
security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 
53).’; 

(22) 

Article 22 is amended as follows: 

(a) 

in paragraph 3, point (d) is replaced by the following: 

‘(d)  any voluntary contribution from the Member States; and 

(e) 

any  revenue  from  contribution  agreements  or  grant  agreements 
exceptionally concluded between the Commission and the Centre.’; 

(b) 

the following paragraph 3a is inserted: 

‘3a  Financing from the Union budget may be awarded to the Centre for the 
costs that it incurs in implementing its  work programme that have been 
established  in  conformity  with  the  objectives  and  priorities  of  the  work 
programmes adopted by the Commission in accordance with Regulation 
(EU)  …/….  of  the  European  Parliament  and  the  Council*,  and  the  EU 
Research  and  Innovation  programmes.  This  financing  shall  not  cover 
expenditure  already  covered  by  the  general  budget  of  the  European 
Union or any other resource of the Centre defined in paragraph 3 of this 
Article.’; 

(c) 

paragraph 5 is replaced by the following: 

‘5.  Each  year,  on  the  basis  of  a  draft  drawn  up  by  the  director,  the 
Management Board shall produce an estimate of revenue and expenditure 
for the Centre for the following financial year. This estimate, including a 
draft  establishment  plan,  shall  be 
the  draft  single 
programming  document.  In  accordance  with  Article  40  of  Regulation 
(EU,  Euratom)  2018/1046  of  the  European  Parliament  and  of  the 
Council**, by 31 January each year the Centre shall send to the European 
Parliament, 
its  draft  single 
programming document, as endorsed by its Management Board.’; 

the  Council  and 

the  Commission 

included 

in 

(d)  paragraph 7 is replaced by the following: 

‘7.  On  the  basis  of  the  estimate,  the  Commission  shall  enter  in  the 
preliminary  draft  general  budget  of  the  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 314 TFEU. 

________________________ 

* 

Regulation (EU) …/… of the European Parliament and of the Council of … on 
the establishment of a Programme for the Union’s action in the field of health 
for  the  period  2021-2027  and  repealing  Regulation  (EU)  No  282/2014 
(‘EU4Health Programme’) (OJ..). 

**  Regulation  (EU,  Euratom)  2018/1046  of  the  European  Parliament  and  of  the 
Council of 18 July 2018 on the financial rules applicable to the general budget 
of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, 
(EU)  No  1303/2013,  (EU)  No  1304/2013,  (EU)  No  1309/2013,  (EU)  No 
1316/2013,  (EU)  No  223/2014,  (EU)  No  283/2014,  and  Decision  No 

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541/2014/EU  and  repealing  Regulation  (EU,  Euratom)  No  966/2012  (OJ  L 
193, 30.7.2018, p. 1).’; 

(23) 

Article 23 is amended as follows: 

(a) 

paragraph 2 is replaced by the following: 

‘2.  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  245  of 
Regulation (EU, Euratom) 2018/1046.’; 

(b)  paragraph 4 is replaced by the following: 

‘4.  On  receipt  of  the  Court  of  Auditors’  observations  on  the  Centre’s 
provisional  accounts,  pursuant  to  Article  246  of  Regulation  (EU, 
Euratom)  2018/1046,  the  director  shall  draw  up  the  Centre’s  final 
accounts under the director’s own responsibility and forward them to the 
Management Board for an opinion. 

The  Centre  shall  inform  the  Commission  without  delay  on  cases  of 
presumed  fraud  and  other  financial  irregularities,  of  any  completed  or 
ongoing  investigations  by  the  European  Public  Prosecutor's  Office  (the 
EPPO) or the European anti-Fraud Office (OLAF), and of any audits or 
controls  by  the  Court  of  Auditors  or  the  Internal  Audit  Service  (IAS), 
without endangering the confidentiality of the investigations.’; 

(c) 

paragraphs 8 and 9 are replaced by the following: 

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

9. 

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 261(3) of Regulation (EU, Euratom) 2018/1046.’; 

(24) 

Article 25 is amended as follows:  

(a) 

paragraph 1 is replaced by the following: 

‘1.  Regulation (EU, Euratom) No 883/2013 of the European Parliament and 

of the Council* shall apply without restriction to the Centre.’; 

(b)  paragraph 3 is replaced by the following: 

‘3.  The decisions concerning funding and the implementing agreements and 
instruments resulting therefrom shall explicitly stipulate that the Court of 
Auditors, the EPPO 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.’ 

(c) 

the following paragraph 4 is added: 

‘4.  Without prejudice to paragraphs 1 to 3, working arrangements with third 
countries  and  with  international  organisations,  grant  agreements,  grant 

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decisions  and  contracts  of  the  Centre  shall  contain  provisions  expressly 
empowering the Court of Auditors, OLAF and the EPPO to conduct such 
audits  and 
respective 
competences. 

in  accordance  with 

investigations, 

their 

_______________ 

* 

Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the 
Council  of  11  September  2013  concerning  investigations  conducted  by  the 
European  Anti-Fraud  Office  (OLAF)  and  repealing  Regulation  (EC)  No 
1073/1999  of  the  European  Parliament  and  of  the  Council  and  Council 
Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).’; 

(25) 

Article 26 is amended as follows:  

(a) 

paragraph 1 is replaced by the following: 

‘1.  The Centre shall be a body of the Union. It shall have legal personality.’; 

(b) 

the following paragraph 1a is inserted: 

‘1a.  In each of the Member States, the Centre shall enjoy the most extensive 
legal  capacity  accorded  to  legal  persons  under  their  laws.  It  may,  in 
particular,  acquire  or  dispose  of  movable  and  immovable  property  and 
may be party to legal proceedings.’; 

(c) 

paragraph 2 is replaced by the following: 

‘2.  Protocol  No 7 on the Privileges and  Immunities of the European Union 

annexed to the Treaties shall apply to the Centre and its statutory staff.’; 

(26) 

paragraph 1 of Article 27 is amended as follows: 

‘1.  The contractual liability of the Centre shall be governed by the law applicable 
to the contract in question. The Court of Justice shall have jurisdiction to give 
judgment pursuant to any arbitration clause contained in a contract concluded 
by the Centre.”; 

(27) 

Article 28 is replaced by the following: 

‘Article 28 

Examination of legality 

1.  Member States, members of the Management Board and third parties directly 
and individually concerned may refer to the Commission any act of the Centre, 
whether express or implied, for the Commission to examine the legality of that 
act (‘administrative appeal’). 

2.  Administrative appeal shall be made to the Commission within 15 days of the 
day on which the party concerned first became aware of the act in question. 

3. 

The  Commission  shall  take  a  decision  within  one  month.  If  no  decision  has 
been  taken  within  this  period,  the  administrative  appeal  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 dismiss the administrative appeal may be brought 
before the Court of Justice in accordance with Article 263 TFEU.’; 

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(28) 

Article 31 is replaced by the following: 

‘Article 31 

Review clause 

1. 

By [please insert date three years after the date of entry into force] 2023, the 
Commission shall submit a report to the European Parliament, the Council and 
the Management Board on the Centre’s activities, including an assessment of: 

(a) 

how  the  Centre  progressed  with  implementing  the  amended  mandate  in 
the light of the COVID-19 pandemic; 

(b)  how the Centre complies with the obligations laid down in the Regulation 
(EU)  …/…  [OJ:  Please  insert  the  number  of  Regulation  SCBTH 
[ISC/2020/12524]] and other relevant Union legislation; 

(c) 

how  effectively  the  Centre’s  activities  address  international,  Union  or 
national health priorities;  

(d)  how  the  work  of  the  Centre  is  targeted  to  and  affect  Member  States’ 

capacities. 

The  report  shall  reflect  the  views  of  the  stakeholders,  at  both  Union  and 
national level. 

The report shall be accompanied by an independent study commissioned by the 
Commission. 

2. 

By [please insert date three years after the date of entry into force] 2028, and 
every 5 years thereafter, the Commission shall assess the Centre’s performance 
in  relation  to  its  objectives,  mandate,  tasks,  procedure  and  location.  The 
evaluation shall, in particular, address the possible need to modify the mandate 
of the Centre, and the financial implications of any such modification. 

3.  Where the Commission considers that the continued operation of the Centre is 
no longer justified with regard to its assigned objectives, mandate and tasks, it 
may  propose  that  the  relevant  provisions  of  this  Regulation  be  amended 
accordingly or repealed.  

4. 

The Commission shall report to the European Parliament, to the Council and to 
the Management  Board  on the findings of its reviews and evaluations carried 
out under paragraph 2. Those findings shall be made public.’  

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 2 

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 

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28 

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LEGISLATIVE FINANCIAL STATEMENT 

Contents 

1. 

• 

• 

• 

2. 

• 

• 

• 

• 

3. 

• 

• 

• 

• 

4. 

5. 

• 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

CONTEXT OF THE PROPOSAL ............................................................................... 1 

Reasons for and objectives of the proposal .................................................................. 1 

Consistency with existing Union measures in this field .............................................. 1 

Consistency with other Union policies ........................................................................ 1 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY ............................... 2 

Legal basis .................................................................................................................... 2 

Subsidiarity (for non-exclusive competence) .............................................................. 2 

Proportionality ............................................................................................................. 2 

Choice of the instrument .............................................................................................. 2 

RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND 
IMPACT ASSESSMENTS .......................................................................................... 3 

Ex-post evaluations/fitness checks of existing legislation ........................................... 3 

Stakeholder consultations ............................................................................................ 3 

Impact assessment ........................................................................................................ 3 

Fundamental rights ....................................................................................................... 4 

BUDGETARY IMPLICATIONS ................................................................................ 4 

OTHER ELEMENTS .................................................................................................. 4 

Detailed explanation of the specific provisions of the proposal .................................. 4 

FRAMEWORK OF THE PROPOSAL/INITIATIVE ............................................... 31 

Title of the proposal/initiative .................................................................................... 31 

Policy area(s) concerned ............................................................................................ 31 

The proposal relates to ............................................................................................... 31 

Objective(s) ................................................................................................................ 31 

1.4.1.  General objective(s) ................................................................................................... 31 

1.4.2.  Specific objective(s) ................................................................................................... 31 

1.4.3.  Expected result(s) and impact .................................................................................... 32 

1.4.4. 

Indicators of performance .......................................................................................... 32 

1.5. 

Grounds for the proposal/initiative ............................................................................ 32 

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for roll-out of 
the implementation of the initiative ........................................................................... 32 

1.5.2.  Added value of Union involvement (it may result from different factors, e.g. coordination 
gains, legal certainty, greater effectiveness or complementarities). For the purposes of this 
point 'added value of Union involvement' is the value resulting from Union intervention which 

EN 

29 

  EN 

is additional to the value that would have been otherwise created by Member States alone.
 .................................................................................................................................... 33 

1.5.3.  Lessons learnt from similar experiences in the past .................................................. 33 

1.5.4.  Compatibility with the Multiannual Financial Framework and possible synergies with other 

appropriate instruments .............................................................................................. 33 

1.5.5.  Assessment of the different available financing options, including scope for redeployment

 .................................................................................................................................... 33 

1.6. 

1.7. 

2. 

2.1. 

2.2. 

2.2.1. 

2.2.2. 

2.3. 

3. 

3.1. 

Duration and financial impact of the proposal/initiative ........................................... 34 

Management mode(s) planned ................................................................................... 34 

MANAGEMENT MEASURES ................................................................................ 35 

Monitoring and reporting rules .................................................................................. 35 

Management and control system(s) ........................................................................... 35 

Justification of the management mode(s), the funding implementation mechanism(s), the 
payment modalities and the control strategy proposed .............................................. 35 

Information concerning the risks identified and the internal control system(s) set up to mitigate 
them ............................................................................................................................ 35 

Measures to prevent fraud and irregularities .............................................................. 36 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE ............ 36 

Heading(s) of the multiannual financial framework and expenditure budget line(s) affected
 .................................................................................................................................... 36 

3.2. 

Estimated impact on expenditure ............................................................................... 38 

3.2.1.  Summary of estimated impact on expenditure ........................................................... 38 

3.2.2.  Estimated impact on ECDC's appropriations ............................................................. 40 

3.2.3.  Estimated impact on [body]'s human resources ......................................................... 45 

3.2.4.  Compatibility with the current multiannual financial framework ............................. 49 

3.2.5.  Third-party contributions ........................................................................................... 49 

3.3. 

Estimated impact on revenue ..................................................................................... 50 

EN 

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LEGISLATIVE FINANCIAL STATEMENT 'AGENCIES' 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative 

Draft  Regulation  (EU)  XXX  of  the  European  Parliament  and  of  the  Council  amending 
Regulation  (EC)  No  851/2004  establishing  a  European  Centre  for  disease  prevention  and 
control 

1.2. 

Policy area(s) concerned 

Policy area: Recovery and Resilience 

Activity: Health  

1.3. 

The proposal relates to  

X a new action  
 a new action following a pilot project/preparatory action13  

X the extension of an existing action  

 a merger of one or more actions towards another/a new action  

1.4. 

Objective(s) 

1.4.1.  General objective(s)  

The  general  objective  of  ECDC’s  work  is  to  assess  and  communicate  current  and  emerging 
threats  to  human  health  from  communicable  diseases  and  provide  recommendations  for 
response at EU and national level. 

1.4.2. 

Specific objective(s)  

Specific objectives  

The ECDC will provide timely information to the Commission, the Member States, EU bodies 
and agencies and international organisations active within the field of public health, including 
risk assessments. 

The  ECDC  will  provide  scientific  and  technical  expertise  to  the  Member  States  and  the 
Commission in the field of preparedness and response planning, including training. 

The  ECDC  will  coordinate  data  collection,  validation,  analysis  and  dissemination  of  data  at 
EU level and thus establish a robust European surveillance system for communicable diseases 
in the frame of the European Health Data Space. 

The  ECDC  will  operate  dedicated  networks  in  the  field  of  communicable  diseases  and 
substances of human origin. 

The  ECDC  will  host  a  EU  Health  Task  Force  to  constantly  support  countries  with 
preparedness strengthening and quickly intervene in a health crisis. 

ECDC will improve international collaboration and gather regional/national intelligence. 

13 

As referred to in Article 58(2)(a) or (b) of the Financial Regulation. 

EN 

31 

  EN 

                                                 
1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

– 

– 

– 

– 

– 

– 

Up-dated  preparedness  plans  in  all  EU  Member  States,  including  audit  and  corretive 
action 

Regularly trained specialists in all EU Member States to manage public health crises 

Established,  functioning  European  networks  of  specialists  for  all  key  communicable 
diseases including emerging diseases 

Timely and pro-active input and support from the ECDC to all Member States and the 
European Commission onresponses to health crises 

Timely and targeted support in case of a health crisis through the EU Health Task Force 

Timely  and  up-to-date  information  and  fluent  collaboration  with  other  CDCs  and 
international health organisations. 

1.4.4. 

Indicators of performance  

Specify the indicators for monitoring progress and achievements. 

Detailed objectives  and  expected  results  including  performance  indicators  will  be  established  by 
the annual work programme, while the multi-annual work programme will set out overall strategic 
objectives, expected results and performance indicators.  

For the specific tasks and actions presented in the current proposal, the following indicators are put 
forward: 

- Number of risk assessments in a pro-active manner if and when needed or upon request by 
the  European  Commission  or  the  Health  Security  Committee  within  1-5  days,  depending  on 
the size of the outbreak or other health security incident.  

- Number of training modules for preparedness being created. 

-  Percentage  of  increase  of  TESSy  capacity  and  up-scaling  of  EWRS  while  preserving  its 
rapidity in exchange of information. 

- Number of rapid, targeted interventions by the EU Health Task Force. 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for roll-out of 

the implementation of the initiative 

One of the lessons learnt in the COVID-19 pandemic is that the health security framework of 
the  EU  needs  strengthening  for  a  better  EU  coordination  of  preparedness  and  responses  to 
serious cross-border health threats. The ECDC is a key player in this framework and needs to 
be strengthened in a targeted manner to carry out an increased array of actions. 

The mandate revision should take place in early 2021 and be implemented immediately. 

1.5.2.  Added  value  of  Union  involvement  (it  may  result  from  different  factors,  e.g.  coordination 
gains,  legal  certainty,  greater  effectiveness  or  complementarities).  For  the  purposes  of  this 
point 'added value of Union involvement' is the value resulting from Union intervention which 
is additional to the value that would have been otherwise created by Member States alone. 

Reasons for action at European level (ex-ante): the ECDC is an established EU decentralised 
Agency  and  its  support  to  Member  States  and  scientific  publications  are  key  elements  for 

EN 

32 

  EN 

preparedness  response  for  cross-border  health  threats.  Based  on  lessons  learnt  from  the 
COVID-19 pandemic, a  mandate revision is  timely to  enhance the preparedness  work in  the 
European Union.  

Expected generated Union added value (ex-post) – Member States will be better prepared to 
confront possible future pandemics and other cross-border health threats. 

1.5.3.  Lessons learnt from similar experiences in the past 

While the Covid-19 pandemic is still ongoing, this proposal builds on the lessons learnt from 
the past months of this pandemic. In particular, better preparedness and monitoring is needed. 

Experience with past revisions of mandates of other EU decentralised agencies was taken into 
account e.g. EFSA. 

1.5.4.  Compatibility  with  the  Multiannual  Financial  Framework  and  possible  synergies  with  other 

appropriate instruments 

The Agency should cooperate and promote synergies with other Union bodies and agencies, such 
as  the  European  Medicines  Agency  (EMA),  the  European  Food  Safety  Authority  (EFSA),  the 
European  Environment  Agency  (EEA)  and  take  full  advantage  and  ensure  consistency  with  the 
EU4Health  programme  and  other  EU  programmes  financing  actions  in  the  domain  of  public 
health. 

1.5.5.  Assessment of the different available financing options, including scope for redeployment 

N/A 

EN 

33 

  EN 

 
 
 
1.6. 

Duration and financial impact of the proposal/initiative 

 limited duration  

–    Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–    Financial impact from YYYY to YYYY 

X unlimited duration 

–  Implementation with a start-up period from Jan 2021 to Dec 2023, 

–  followed by full-scale operation. 
1.7.  Management mode(s) planned14  

 Direct management by the Commission through 

–    executive agencies  

 Shared management with the Member States  

X Indirect management by entrusting budget implementation tasks to: 

 international organisations and their agencies (to be specified); 

the EIB and the European Investment Fund; 

X bodies referred to in Articles 70 and 71; 

 public law bodies; 

 bodies governed by private law with a public service mission to the extent that they provide 
adequate financial guarantees; 

  bodies  governed  by  the  private  law  of  a  Member  State  that  are  entrusted  with  the 
implementation of a public-private partnership and that provide adequate financial guarantees; 

  persons  entrusted  with  the  implementation  of  specific  actions  in  the  CFSP  pursuant  to 
Title V of the TEU, and identified in the relevant basic act. 

Comments 

14 

Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the  BudgWeb  site: 
https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx. 

EN 

34 

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2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

All  Union  agencies  work  under  a  strict  monitoring  system  involving  an  internal  control 
coordinator,  the  Internal  Audit  Service  of  the  Commission,  the  Management  Board,  the 
Commission, the Court of Auditors and the Budgetary Authority. This system is reflected and laid 
down in the ECDC’s founding regulation.  

In accordance with the Joint Statement on the EU decentralised agencies (the ‘common approach’) 
and  the  framework  financial  regulation  (2019/715),  the  annual  work  programme  of  the  Agency 
shall  comprise  detailed  objectives  and  expected  results  including  set  up  performance  indicators. 
The Agency will accompany its activities included in its working programme by key performance 
indicators.  The  activities  of  the  Agency  will  then  be  measured  against  these  indicators  in  the 
Consolidated  Annual  Activity  Report.  The  annual  work  programme  shall  be  coherent  with  the 
multi-annual  work  programme  and  both  shall  be  included  in  an  annual  single  programming 
document which shall be submitted to the European Parliament, the Council and the Commission.  

The  Management  Board  of  the  Agency  is  responsible  for  the  supervision  of  the  administrative, 
operational and budgetary efficient management of the Agency  

Every five years (next evaluation to cover 2018-2022) the Commission shall assess the Agency's 
performance  in  relation  to  its  objectives,  mandate  and  tasks.  The  evaluation  shall,  in  particular, 
address the possible need to modify the mandate of the Agency, and the financial implications of 
any such modification. The Commission shall report to the European Parliament, the Council and 
the Management Board on the evaluation findings. The findings of the evaluation shall be made 
public. 

2.2.  Management and control system(s)  

2.2.1. 

Justification  of  the  management  mode(s),  the  funding  implementation  mechanism(s),  the 
payment modalities and the control strategy proposed 

The  annual  EU  subsidy  is  transferred  to  the  Agency  in  accordance  with  its  payment  needs  and 
upon its request.  

The Agency will be subject to administrative controls including budgetary control, internal audit, 
annual  reports  by  the European  Court  of  Auditors, the annual  discharge  for  the  execution  of  the 
EU  budget  and  possible  investigations  conducted  by  OLAF  to  ensure,  in  particular,  that  the 
resources  allocated  to  agencies  are  put  to  proper  use.  The  activities  of  the  Agency  will  also  be 
subject to the supervision of the Ombudsman in accordance with Article 228 of the Treaty. These 
administrative controls provide a number of procedural safeguards to ensure that account is taken 
of the interests of the stakeholders. 

2.2.2. 

Information  concerning  the  risks  identified  and  the  internal  control  system(s)  set  up  to 
mitigate them 

The main  risk  relates to under  or  non  implementation  of  the tasks  foreseen.  In  order  to mitigate 
this, enough resources should be made available in both financial and staffing terms. 

EN 

35 

  EN 

 
 
2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures, e.g. from the Anti-Fraud Strategy. 

Anti-fraud measures are foreseen in Article 25 of the founding regulation of European Centre for 
Disease Prevention and Control and the Executive Director and the Management Board will take 
the appropriate measures in accordance with the Internal Control Principles applied across all EU 
institutions. In line with the Common Approach the anti-fraud strategy has been developed and is 
applied by the Agency. 

The mandate of the ECDC clearly states that the provisions of Regulation (EU, Euratom) No 
883/2013 shall apply without restriction. 

The  ECDC  also  accedes  to  the  Inter-institutional  Agreement  of  25  May  1999  concerning 
internal  investigations  by  the  European  Anti-fraud  Office  (OLAF)  (10)  and  shall  issue, 
without delay, the appropriate provisions applicable to all of its staff. 

The ECDC’s 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. 

In  accordance  with  Regulation  (EU)  2017/1939,  the  European  Public  Prosecutor's  Office 
(EPPO) may investigate and prosecute fraud and other illegal activities affecting the financial 
interests of the Union as provided for in Directive (EU) 2017/1371. 

If  the  ECDC  concludes  working  arrangements  with  third  countries  and  with  international 
organisations,  grant  agreements, grant decisions and contracts, these shall contain provisions 
expressly  empowering  the  Court  of  Auditors,  OLAF  and  EPPO  to  conduct  such  audits  and 
investigations, in accordance with their respective competences. 

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Given the on-going reflection on the creation of an EU BARDA, the Commission retains the right to 
adjust the proposed resources and staff allocation when a precise proposal for a EU BARDA is tabled.  

3.1. 

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

  Existing budget lines  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Heading of 
multiannual 
financial 
framework 

Number  

Type of  
expenditure 

Non-diff.15 

Contribution  

from 
EFTA 
countries
16 

from 
candidate 
countries17 

from third 
countries 

within the meaning 
of Article 21(2)(b) 
of the Financial 
Regulation  

15 
16 
17 

Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidates from the Western Balkans. 

EN 

36 

  EN 

 
 
                                                 
2 

06.1001 

Diff. 

YES 

NO 

NO 

NO 

  New budget lines requested  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of 
expenditure 

Contribution  

Heading of 
multiannual 
financial 
framework 

Number  

[XX.YY.YY.YY] 

Diff./non-
diff. 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the meaning 
of Article 21(2)(b) 
of the Financial 
Regulation  

YES/NO  YES/NO  YES/NO 

YES/NO 

EN 

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3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial  
framework  

Number  Heading 2 : Cohesion, Resilience and Values 

EUR million (to three decimal places) 

[Body]: ECDC 

Title 1: 

Title 2: 

Title 3: 

TOTAL appropriations 
for ECDC 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026 

2.965 
2.965 
0.775 
0.775 
 12.300 

5.475 
5.475 
1.375 
1.375 
 16.500 

6.680 
6.680 
1.700 
1.700 
 16.700 

7.165 
7.165 
1.825 
1.825 
 17.000 

7.165 
7.165 
1.825 
1.825 
 14.000 

7.165 
7.165 
1.825 
1.825 
 13.000 

Year 
2027 et 
seqq. 

7.165 
7.165 
1.825 
1.825 
 13.000 

 12.300 

 16.500 

 16.700 

 17.000 

 14.000 

 13.000 

 13.000 

TOTAL 

43.780 
43.780 
11.150 
11.150 

102.500 

102.500 

 16.040  

 23.350  

 25.080  

 25.990  

 22.990  

 21.990  

 21.990  

157.430 

 16.040  

 23.350  

 25.080  

 25.990  

 22.990  

 21.990  

 21.990  

157.430 

Commitments 
Payments 

Commitments 

Payments 

Commitments 

Payments 

Commitments 

Payments 

(1) 

(2) 

(1a) 

(2a) 

(3a) 

(3b) 

=1+1a 
+3a 

=2+2a 

+3b 

EN 

38 

EN 

 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial  
framework  

7 

‘Administrative expenditure’ 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 et 
seqq. 

TOTAL 

EUR million (to three decimal places) 

DG: <…….> 

 Human Resources  
 Other administrative expenditure  

TOTAL DG <…….> 

Appropriations  

TOTAL appropriations 
under HEADING 7 
of the multiannual financial framework  

(Total  commitments  = 
Total payments) 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 et 
seqq. 

TOTAL 

EUR million (to three decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 7 
of the multiannual financial framework  

Commitments 

 16.040  

 23.350  

 25.080  

 25.990  

 22.990  

 21.990  

 21.990  

157.430 

Payments 

 16.040  

 23.350  

 25.080  

 25.990  

 22.990  

 21.990  

 21.990  

157.430 

EN 

39 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on ECDC's appropriations  

–    The proposal/initiative does not require the use of operational appropriations  

–   The proposal/initiative requires the use of operational appropriations, as explained below: 

Commitment appropriations in EUR million (to three decimal places) 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 et 
seqq. 

TOTAL 

OUTPUTS 

o
N

Cost  N

o

Cost 

o
N

Cost 

o
N

Cost  N

o

Cost  N

o

Cost  N

o

Cost 

Total 
No 

Total 
cost 

Indicate objectives 
and outputs  

 

Ty
pe
18 

Ave
rage 
cost 

SPECIFIC OBJECTIVE No 1 provide timely information to the Commission, the Member States, EU agencies and international organisations 
active within the field of public health, including risk assessments 

18 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 

EN 

40 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
                                                 
7.000 

7.000 

6.800 

6.800 

6.800 

6.800 

6.800 

48.000 

- Output set-up a 
new  platform 
hosted jointly by 
EMA and ECDC, 
for post-marketing 
surveillance studies, 
monitoring the 
safety, effectiveness 
and impact of 
vaccination, 
forthcoming 
COVID-19 vaccines 
should be the first 
vaccines to be 
monitored under this 
platform mechanism 

- Output 

- Output 

Subtotal for specific objective No 
1 

7.000 

7.000 

6.800 

6.800 

6.800 

6.800 

6.800 

48.000 

SPECIFIC OBJECTIVE No 2 ECDC will provide scientific and technical expertise to the Member States and the Commission in the field of preparedness and response planning, 
including training 

Output:  training programmes for 
specialists, in particular in 
epidemiological surveillance and 
field investigations, and to have a 
capability to define health 
measures to control disease 
outbreaks. 

Output: preparedness and 
response planning activities 
including modelling, monitoring 
and assessment 

0.100 

0.100 

0.100 

0.100 

0.100 

0.100 

0.100 

0.700 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

7.000 

EN 

41 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subtotal for specific objective No 
2 

1.100 

1.100 

1.100 

1.100 

1.100 

1.100 

1.100 

7.700 

SPECIFIC OBJECTIVE No 3 operate dedicated networks in the field of communicable diseases and substances of human origin 

- Output: new 
network on 
transfusion, 
transplantation and 
medically assisted 
reproduction 

- Output: strengthen 
the network of 
laboratories, inline 
with EC 
Communication 
C(2020) 2391 
“Guidelines on 
COVID-19 in vitro 
diagnostic tests and 
their performance” 
Subtotal for specific objective No 
3 

0.300 

0.300 

0.300 

0.300 

0.300 

0.300 

0.300 

2.100 

0.200 

0.200 

0.200 

0.200 

0.200 

0.200 

0.200 

1.400 

0.500 

0.500 

0.500 

0.500 

0.500 

0.500 

0.500 

3.500 

SPECIFIC OBJECTIVE No 4 ECDC will coordinate data collection, validation, analysis and dissemination of data at EU level and thus establish a robust European surveillance system 
for communicable diseases in the frame of the European Health Data Space 

Output: new node at ECDC for 
the transmission of information 
from national level to ECDC by 
enlarging Tessy (greater 
capacity). 

Output: strengthened EWRS 
making the system more scalable, 
without changing purpose of the 

2.000 

5.000 

5.000 

5.000 

3.000 

2.000 

2.000 

24.000 

1.000 

2.000 

2.000 

2.000 

1.000 

1.000 

1.000 

10.000 

EN 

42 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
system to support the rapid 
exchange of information with 
epidemiological institutions and 
public research institutions during 
pandemic at national and EU 
level. 

Subtotal for specific objective No 
4 

3.000 

7.000 

7.000 

7.000 

4.000 

3.000 

3.000 

34.000 

SPECIFIC OBJECTIVE No 5 ECDC will host an outbreak assitance team ("EU Health Task Force") to constantly support countries with preparedness preparation and quickly intervene 
in a health crisis 

Output: pro-active, demand 
driven, practical support to EU 
/EEA countries 

Output: local intervention in EU 
crisis spots -upon request, 
coordination with national 
specialists supporting the team 

Subtotal for specific objective No 
5 

Output: on the spot coordination 
with with international authorities 
and other CDCs 

Output: gathering of local 
intelligence and providing expert 
support 

Subtotal for specific objective No 
6 

0.500 

0.500 

0.500 

0.500 

0.500 

0.500 

0.500 

3.500 

0.100 

0.100 

0.100 

0.100 

0.100 

0.100 

0.100 

0.700 

0.600 

0.600 

0.600 

0.600 

0.600 

0.600 

0.600 

4.200 

SPECIFIC OBJECTIVE No 6 improve international collaboration and gather regional/national intelligence 

0.050 

0.150 

0.350 

0.500 

0.500 

0.500 

0.500 

2.550 

0.050 

0.150 

0.350 

0.500 

0.500 

0.500 

0.500 

2.550 

0.100 

0.300 

0.700 

1.000 

1.000 

1.000 

1.000 

5.100 

EN 

43 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TOTAL COST 

12.300 

16.500 

16.700 

17.000 

14.000 

13.000 

13.000 

102.500 

EN 

44 

EN 

 
 
 
 
 
 
 
 
 
 
3.2.3.  Estimated impact on [body]'s human resources  

3.2.3.1.  Summary  

–    The  proposal/initiative  does  not  require  the  use  of  appropriations  of  an 

administrative nature  

–   The proposal/initiative requires the use of appropriations of an administrative 

nature, as explained below: 

EUR million (to three decimal places) 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 et 
seqq. 

TOTAL 

Temporary agents (AD 
Grades) 

Temporary 
(AST grades) 

agents 

Contract staff 

Seconded National 
Experts 

1.650 

3.300 

4.350 

4.800 

4.800 

4.800 

4.800 

28.500 

1.050 

1.950 

1.950 

1.950 

1.950 

1.950 

1.950 

12.750 

1.040 

1.600 

2.080 

2.240 

2.240 

2.240 

2.240 

13.680 

0 

0 

0 

0 

0 

0 

0 

0 

TOTAL 

3.740 

6.850 

8.380 

8.990 

8.990 

8.990 

8.990 

54.930 

Staff requirements (FTE): 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 et 
seqq. 

TOTAL 

Temporary agents (AD 
Grades) 

Temporary 
(AST grades) 

agents 

Contract staff 

Seconded National 
Experts 

11 

7 

13 

0 

22 

13 

20 

0 

29 

13 

26 

0 

32 

13 

28 

0 

32 

13 

28 

0 

32 

13 

28 

0 

32 

13 

28 

0 

32 

13 

28 

0 

TOTAL 

31 

55 

68 

73 

73 

73 

73 

73 

EN 

45 

  EN 

 
 
 
 
 
 
 
 
 
Please indicate the planned recruitment date and adapt the amount accordingly (if recruitment 
occurs  in  July,  only  50 %  of  the  average  cost  is  taken  into  account)  and  provide  further 
explanations.  

EN 

46 

  EN 

 
3.2.3.2.  Estimated requirements of human resources for the parent DG 

–  X  The proposal/initiative does not require the use of human resources.  

–    The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

Estimate to be expressed in full amounts (or at most to one decimal place) 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 et 
seqq. 

 Establishment plan posts (officials and 

temporary staff) 

XX 01 01 01 (Headquarters and 
Commission’s Representation 
Offices) 

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

 External staff (in Full Time Equivalent 

unit: FTE)19 

XX 01 02 01 (AC, END, INT from 
the ‘global envelope’) 

XX 01 02 02 (AC, AL, END, INT 
and JPD in the Delegations) 

XX 01 04 
yy20 

- at 
Headquarters21 

- in 
Delegations  

XX 01 05 02 (AC, END, INT – 
Indirect research) 

10 01 05 02 (AC, END, INT – 
Direct research) 

Other budget lines (specify) 

TOTAL 

XX is the policy area or budget title concerned. 

The human resources required will be met by staff from the DG who are already assigned to 
management of the action and/or have been redeployed within the DG, together if necessary 

19 

20 
21 

AC = Contract Staff; AL = Local Staff; END = Seconded National Expert; INT = agency staff; JPD = 
Junior Professionals in Delegations .  
Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines). 
Mainly for the Structural Funds, the European Agricultural Fund for Rural Development (EAFRD) and 
the European Fisheries Fund (EFF). 

EN 

47 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
with any additional allocation which may be granted to the managing DG under the annual 
allocation procedure and in the light of budgetary constraints. 

Description of tasks to be carried out: 

Officials and temporary staff 

External staff 

Description  of  the  calculation  of  cost  for  FTE  units  should  be  included  in  the  Annex  V, 
section 3.  

EN 

48 

  EN 

 
 
 
 
3.2.4.  Compatibility with the current multiannual financial framework  

–    The  proposal/initiative  is  compatible  the  current  multiannual  financial 

framework. 

–  X The proposal/initiative will entail reprogramming of the relevant heading in the 

multiannual financial framework. 

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts. 

The  proposed  additional  budget  for  ECDC  may  be  financed  by  a  reduction  of 
EU4Health budget in future years. 

–    The  proposal/initiative  requires  application  of  the  flexibility  instrument  or 

revision of the multiannual financial framework22. 

Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts. 

3.2.5.  Third-party contributions  

–  The proposal/initiative does not provide for co-financing by third parties.  

–  The proposal/initiative provides for the co-financing estimated below: 

EUR million (to three decimal places) 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 et 
seqq. 

TOTAL 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

Specify  the  co-financing 
body  

TOTAL 
co-financed  

appropriations 

22 

See  Articles  11  and  17  of  Council  Regulation  (EU,  Euratom)  No  1311/2013  laying  down  the 
multiannual financial framework for the years 2014-2020. 

EN 

49 

  EN 

 
 
 
 
 
                                                 
3.3. 

Estimated impact on revenue  

–  X  The proposal/initiative has no financial impact on revenue. 

–    The proposal/initiative has the following financial impact: 

– 

– 

– 

 

 

on own resources  

on other revenue  

 please indicate, if the revenue is assigned to expenditure lines  

Appropriation
s available for 
the current 
financial year 

Budget revenue line: 

Article …………. 

EUR million (to three decimal places) 

Impact of the proposal/initiative23 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 et 
seqq. 

For miscellaneous ‘assigned’ revenue, specify the budget expenditure line(s) affected. 

Specify the method for calculating the impact on revenue. 

23 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 20 % for collection costs. 

EN 

50 

  EN