Proposal for a DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on serious cross-border threats to health
Date: 2011-12-08
Institutions: European Commission
Subjects: cross-border cooperation, disease prevention, epidemiology, health control, health risk, infectious disease

EUROPEAN COMMISSION 

Brussels, 8.12.2011 
COM(2011) 866 final 

2011/0421 (COD) 

Proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on serious cross-border threats to health  

(Text with EEA relevance) 

{SEC(2011) 1519 final} 
{SEC(2011) 1520 final} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSED ACT 

1.1. 

Reasons for and objectives of the proposal 

The aim of the proposed Decision is to streamline and strengthen European Union capacities 
and structures for effectively responding to serious cross-border health threats. These threats 
can  be  events  caused  by  communicable  diseases,  biological  agents  responsible  for  non-
communicable diseases, and threats of chemical, environmental, or unknown origin1. Threats 
deriving from the effects of climate change (i.e. heat waves, cold spells) are included in the 
scope of this Decision and covered under the same heading as environmental threats. 

Health threats of radiological or nuclear origin causing exposure to ionising radiation are not 
covered by this proposal because they are already dealt with by the provisions of the Treaty 
establishing  the  European  Atomic  Energy  Community  (Articles  2(b)  and  30-39),  which 
constitutes the ‘lex specialis’ in relation to Article 168 of the Treaty on the Functioning of the 
European Union. 

Based on lessons learnt from recent public health emergencies and building on existing EU-
level instruments related to health threats, this proposal will set up a coherent framework for 
crisis response. 

Although the Member States have the responsibility to manage public health crises at national 
level,  no  country  can  tackle  a  cross  border  public  health  crisis  on  its  own.  In  the  current 
financial turmoil it is more important than ever to focus on actions in areas where the added 
value  is  evident,  such  as  minimising  the  negative  effects  of  a  potential  public  health  crisis. 
Recent cross-border events such as the H1N1 pandemic in 2009, the volcanic ash cloud and 
toxic  red  sludge  in  2010,  or  the  outbreak  of  E.  coli  STEC  O104  in  2011,  had  significant 
effects  on  society  and  demonstrated  that  none  of  the  impacts  of  these  emergencies  can  be 
confined  to  only  one  sector.  Therefore,  through  improved  multi-sectoral  cooperation  at  EU 
level other sectors need to be equally prepared to manage the impacts of a public health crisis. 

At  EU  level,  the  legal  basis  for  addressing  serious  cross-border  health  threats  has  been 
reinforced with the Lisbon Treaty. The EU can now take action in this field, except for any 
harmonisation of the laws and regulations of the Member States. Also, the Treaty stipulates 
that  the  EU  must  complement  and  support  national  policies  and  encourage  cooperation 
between Member States, without superseding their competence in that field. 

So far, EU legislation in this area only addresses threats related to communicable diseases2. 
The  EU  network  for  surveillance  and  control  of  communicable  diseases  has  specific 
mechanisms  for  monitoring  communicable  diseases,  giving  alerts  and  coordinating  the  EU 
response.  Because  its  scope  is  limited  to  communicable  diseases,  however,  the  network  no 
longer meets the current standards or needs for an improved EU response to all serious cross-
border health threats and will therefore be replaced by this Decision. The Decision covers all 

1 
2 

Including threats of malicious intentional origin 
Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting 
up  a  network  for  the  epidemiological  surveillance  and  control  of  communicable  diseases  in  the 
Community (OJ L 268, 3.10.1998, p. 1) 

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serious  cross-border  threats  to  health  except  for  those  caused  by  radiological  or  nuclear 
exposure. 

The objectives of the proposed Decision are as follows: 

Firstly, in the area of preparedness planning, the Decision provides for the coordination of the 
efforts of the Member States in terms of improved preparedness and capacity building. To this 
end,  the  Commission  will  ensure  coordination  between  national  planning  and  between  key 
sectors  such  as  transport,  energy  and  civil  protection,  and  will  support  Member  States  in 
setting up a joint procurement mechanism for medical countermeasures. 

Secondly,  in  order  to  provide  the  relevant  information  and  data  for  risk  assessment  and 
monitoring  of  emerging  threats,  an  ad  hoc  network  will  be  set  up  in  situations  where  a 
Member  State  has  raised  an  alert  on  a  serious  threat  other  than  a  communicable  disease. 
Communicable diseases will continue to be monitored as they are today. 

Thirdly, the Decision expands the use of the existing Early Warning and Response System to 
cover all serious threats to health, and not only communicable diseases as is the case today. 

Fourthly,  the  proposal  introduces  coordinated  development  of  national  or  European  public 
health risk assessments for threats of biological, chemical, environmental or unknown origin 
in a crisis situation. 

Finally,  the  Decision  sets  up  a  coherent  framework  for  the  EU  response  to  a  public  health 
crisis. In concrete terms, by formalising the existing Health Security Committee, the EU will 
be in a better position to coordinate national crisis responses in a public health emergency. 

1.2. 

General context 

The  proposal  will  help  implement  the  European  Health  Strategy3  and  also  contribute  to 
Europe  20204  by  promoting  health  as  an  integral  part  of  the  smart  and  inclusive  growth 
objectives. The proposal will also contribute to implementing the Internal Security Strategy in 
its crises and disasters management component5, notably the overall  objective to  establish a 
coherent risk management policy linking threat and risk assessment to decision making. The 
Health  Security  Initiative  will  appropriately  take  into  account  the  EU  external  cooperation 
activities  for  health  crises  prevention  and  responses  with  third  countries  and  activities 
supported  under  the  Union's  programmes  for  research,  and  explore  synergies  with  the 
numerous  bilateral  EU  assistance  and  cooperation  programmes  with  a  significant  health 
component. 

Many  activities  related  to  preparedness  and  response  planning  and  risk  assessment  for 
communicable diseases but also for chemical threats to health and events caused by climate 
change have been supported by the previous and current health programme. It is planned that 

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5 

White Paper of 23 October 2007 — Together for Health: A Strategic Approach for the EU 2008-2013, 
COM(2007) 630 final 
Communication  from  the  Commission  of  3  March  2010  —  Europe  2020:  A  strategy  for  smart, 
sustainable and inclusive growth, COM(2010) 2020 final 
EU  Internal  Security  Strategy  in  Action:  Five  steps  towards  a  more  secure  Europe,  22.11.2010  -
COM(2010) 673 final – Objective 5: Increase Europe's resilience to crises and disasters – Action 2: an 
all-hazards approach to threat and risk assessment 

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for important elements of the initiative, specific actions will be supported by the future Health 
programme currently under development6. 

The  EU  already  has  policies,  mechanisms  and  instruments  in  place  for  the  prevention  and 
control of serious cross-border threats and for the development of capacities to manage crises. 
A  non-exhaustive  list  includes  the  EU  Civil  Protection  Mechanism,  the  Cohesion  and 
Solidarity  Funds,  the  EU  action  plan  on  chemical,  biological,  radiological  and  nuclear 
security7, and European alert networks such as ECURIE8. 

In  addition,  to  support  the  EU  security  framework  and  to  protect  citizens  against  serious 
cross-border  threats,  different  alert,  information  and  management  systems,  scientific 
committees  and  agencies  are  already  operating  to  ensure  food  and  feed  safety,  animal  and 
plant  health,  medical  products  safety,  and  consumer  protection.  Systems  have  been  put  in 
place  to  control  chemical  accidents  and  radiological  events,  for  border  security  and  for 
protection against crime and terrorism. 

In  order  to  avoid  overlaps  with  these  areas  and  duplicating  existing  disaster  prevention  and 
control structures, a gap analysis has been carried out to assess how far these existing systems 
cover  the  monitoring  of  threats  to  health,  their  notification,  risk  assessment  and  crisis 
management  capacities  and  structures  from  the  public  health  perspective.  This  gap  analysis 
revealed that the existing structures and mechanisms at EU level do not address these threats 
sufficiently9 as far as public health is concerned. For example, there is a variety of monitoring 
and alert systems for different threats at EU level, but these are not systematically linked to 
EU public health institutions. In addition, the International Health Regulations (IHR) (2005)10 
—  an  international  treaty  for  the  coordination  of  all  health  emergencies  —  stipulate  that 
Member States must notify the World Health Organisation of any event that may constitute a 
public  health  emergency  of  international  concern,  independently  of  its  origin  (including 
biological, chemical or environmental). But there are no similar notification obligations at EU 
level under any of the existing structures. 

As  regards  risk  assessment,  national  public  health  risk  assessments  exist,  but  may  not  be 
comprehensive  and  consistent  when  considered  from  the  EU  perspective,  and  there  is 
currently no mechanism for a coordinated approach at EU level. The lack of public health risk 
assessment  at  EU  level  leads  to  discrepancies  in  evaluating  the  danger  of  a  given  threat, 
duplication  of  assessments  between  Member  States  and  inconsistent  measures  at  EU  level. 
Such  a  situation  can  also  lead  to  inefficient  use  of  the  limited  resources  currently  available 
and  may  delay  appropriate  public  health  measures,  potentially  putting  at  risk  the  overall 
response at EU level. The absence of a comprehensive or proper evaluation of risks may lead 
to  unclear  communication  and  may  undermine  public  confidence  in  measures  proposed  or 
taken by public health authorities in Member States. 

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10 

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:301:0003:0013:EN:PDF; 
http://ec.europa.eu/health/programme/docs/prop_prog2014_en.pdf 
Communication from the Commission of 24 June 2009 to the European Parliament and the Council on 
Strengthening Chemical, Biological, Radiological and Nuclear Security in the European Union – an EU 
CBRN Action Plan COM(2009) 273 final  
European Community Urgent Radiological Information Exchange (ECURIE). 
Please refer to the impact assessment report for further details, in particular Appendix 2 ‘Structures for 
preparedness and response to cross-border health threats’. 
http://www.who.int/ihr/en/ 

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Apart from the instruments in the area of radiological protection, existing mechanisms do not 
provide  a  comprehensive  basis  for  decisions  on  public  health  measures  for  the  population 
where there is a severe health impact such as contamination or poisoning caused by chemical, 
biological  or  environmental  events.  This  has  led  to  a  situation  where  today  there  is  no 
possibility  for  a  coordinated  EU  response  with  public  health  measures  or  agreements  on 
prophylaxis  and  treatment.  These  kinds  of  cross-border  public  health  emergencies  are 
addressed case by case on an ad hoc basis. Therefore, the proposal will build on the existing 
instruments,  step  up  cooperation  and  strengthen  coordination  in  the  area  of  notification  and 
risk assessment. 

As  regards  preparedness  planning,  during  the  H1N1  influenza  pandemic  in  2009,  Member 
States  procuring  pandemic  influenza  vaccines  individually  were  competing  with  each  other 
for  limited  amounts  of  available  vaccine,  which  weakened  their  purchasing  power. 
Contractual  confidentiality  clauses  often  prevented  Member  States  from  exchanging 
information,  leading  –  as  shown  in  an  independent  evaluation11  –  to  considerable  variations 
between Member States as regards contractual conditions, particularly regarding liability for 
side effects being transferred from the manufacturers to the Member States. In addition, the 
lack of flexibility in contracts to include conditions under which the reserved amount of doses 
could be changed or excess vaccines could be returned resulted in a huge waste of resources. 
The Member States that could not accept those unfavourable conditions had no guarantee of 
being able to obtain pandemic influenza vaccines, thus weakening the preparedness across the 
EU  for  such  a  cross-border  health  threat.  This  could  have  had  very  serious  health 
consequences if the pandemic had proved more virulent and deadly. 

Furthermore, in the aftermath of the H1N1 pandemic in 2009, the European Parliament in its 
resolution  of  8  March  2011  and  the  Council  in  its  conclusions  of  13  September  201012 
stressed  the  need  to  introduce  a  common  procedure  for  the  joint  procurement  of  medical 
countermeasures,  and  in  particular  of  pandemic  vaccines,  to  allow  Member  States,  on  a 
voluntary basis, to benefit from such purchases. 

This  proposal  provides  a  legal  basis  for  an  EU  mechanism  for  the  joint  procurement  of 
medical countermeasures in which contracting parties13 could participate on a voluntary basis 
in order to purchase medical countermeasures, such as pandemic influenza vaccines, thereby 
improving preparedness for future pandemics. 

In relation to crisis management, and in view of the lessons learnt from recent emergencies, 
health  ministers  have  repeatedly  called  for  a  review  of  the  health  security  framework, 
including options for a legal basis for the Health Security Committee, and stressed the need to 
review pandemic preparedness planning. 

The  Health  Security  Committee  is  currently  an  informal  structure  at  EU  level  for  the 
coordination  of  public  health  risk  assessment  and  the  management  of  serious  cross-border 
threats to health. It was set up by the EU health ministers in the aftermath of the 11 September 
2001  terrorist  attacks  in  the  United  States.  At  the  beginning,  its  mandate  was  limited  to 

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http://ec.europa.eu/health/communicable_diseases/docs/assessment_vaccine_en.pdf 
Council Conclusions of 13 September 2010 on lessons learned from the A/H1N1 pandemic — health 
security in the European Union (12665/10). 
Potential  contracting  parties:  Member  States  and  the  European  Commission  (the  latter  procuring 
medical countermeasures on behalf of all interested EU institutions for coverage of staff) 

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tackling  bioterrorism14,  but  it  has  subsequently  been  extended  to  cover  all  types  of  public 
health-related  crisis15.  It  is  composed  of  representatives  of  the  Member  States’  health 
authorities and chaired by the Commission. 

Due to the informal nature of the Committee, the involvement and commitment of Member 
States  is  voluntary  and  there  is  insufficient  coordination  of  public  health  responses  and  no 
cross-sectoral  interlinking  of  decision-making  processes  in  public  health.  The  Commission 
can  prepare  and  table  recommendations  and  advice.  By  formalising  the  Health  Security 
Committee,  it  can  be  expected  that  public  health  preparedness  planning  and  crisis 
management  can  be  taken  forward  in  a  more  consistent  and  comprehensive  manner  at  EU 
level.  In  addition,  Member  States  will  benefit  from  pooling  scarce  resources  related  to  risk 
assessment or crisis management, for example. 

1.3. 

Existing European Union and international provisions in this area 

The  Community  network  for  the  epidemiological  surveillance  and  control  of  communicable 
the  epidemiological 
diseases  established  under  Decision  No  2119/98/EC  comprises 
surveillance  of  communicable  diseases  and  the  Early  Warning  and  Response  System 
(EWRS). 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  Control16  (ECDC) 
provides  the  ECDC  with  a  mandate  covering  surveillance  and  risk  assessment  of  threats  to 
human health from communicable diseases and illnesses of unknown origin. In this context, 
the ECDC has taken over the epidemiological surveillance of communicable diseases and the 
operation of the EWRS from the Community network. For this reason the proposed Decision 
repeals Decision No 2119/98/EC. 

The  Treaty  on  the  Functioning  of  the  European  Union  (TFEU)  covers  several  aspects  of 
health  security,  including  EU  disaster  prevention  and  control.  Mechanisms  related  to  EU 
disaster  prevention,  response  and  control  are  dealt  with  under  civil  protection  (Article  196 
TFEU), the solidarity clause (Article 222 TFEU), EU financial assistance to Member States 
(Article 122 TFEU), and humanitarian aid to third countries (Article 214 TFEU). 

In addition, some health security aspects are already addressed within areas of common safety 
concern in public health matters (such as food safety, animal and plant health, the quality and 
safety  of  pharmaceuticals  and  medical  devices,  or  organs  and  substances  of  human  origin, 
blood  and  blood  derivatives),  consumer  protection,  health  and  safety  at  work,  the 
environment, transport safety and security, respectively covered by Articles 168(4), 169, 153-
156,  191-193,  141  and  91  of  the  TFEU.  Furthermore,  an  information  system  will  be  put  in 
place by 1 June 2015 by the Directive 2010/65/EU. It will help Member States to improve the 
monitoring  and  early  warning  of  threats  deriving  from  sea  vessels.  The  Directive  includes 
provisions  permitting  an  electronic  exchange  of  data  notified  in  the  dangerous  goods 
declaration and the marine declaration of health.17 

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Presidency Conclusions of 15 November 2001 on bioterrorism (13826/01) 
Council Conclusions of 22 February 2007 on the transitional prolongation and extension of the mandate 
of the HSC (6226/07) 
OJ L 142, 30.4.2004, p. 1 
Directive 2010/65/EU of the European Parliament and of the Council of 20 October 2010 on reporting 
formalities  for  ships  arriving  in  and/or  departing  from  ports  of  the  Member  States  and  repealing 
Directive 2002/6/EC, OJ L 283, 29.10.2010, p. 1 

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Furthermore, EU secondary legislation establishes specific rules for monitoring, giving early 
warning of and combating serious cross-border threats to health (e.g. the Seveso II Directive18 
and  the  CAFE  Directive19)  and  requires  in  a  few  instances  Member  States  to  develop  joint 
activities  to  address  transboundary  air  pollution  including  recommended  behaviour  (CAFE 
Directive).  For  these  reasons  this  Decision  does  not  impinge  on  the  provisions  that  already 
exist but seeks to close the gaps in relation to notifications, monitoring, risk assessment and 
crisis  management  from  the  public  health  perspective.  Therefore,  the  Decision  extends  the 
Early Warning and Response System to cover all serious cross-border threats to health (except 
radio  nuclear),  adds  a  monitoring  requirement  in  a  crisis  for  threats  to  health  other  than 
communicable diseases and provides for a crisis management structure for addressing health 
threats, as these are not covered under other legislation. 

The  International  Health  Regulations  (2005)  already  require  Member  States  to  develop, 
strengthen  and  maintain  the  capacity  to  detect,  assess,  notify  and  respond  to  public  health 
emergencies of international concern. Under this agreement, the World Health Organisation is 
empowered  to  declare  public  health  emergencies  of  international  concern  and  to  issue 
recommendations  including  health  measures.  The  proposed  Decision  aims  to  support  the 
consistent and coordinated implementation of the International Health Regulations by the EU 
Member States. In particular, it will ensure adequate coordination between the Member States 
to  achieve  a  consistent  level  of  preparedness  and  interoperability  between  national 
preparedness plans, while respecting the Member States’ responsibility for the organisation of 
their health systems. 

Against this background, the Decision should apply without prejudice to other legally binding 
provisions relating to health security, not least as regards preparedness, monitoring, alerting, 
assessment and management of serious cross-border threats to health. However, where gaps 
have been identified in relation to monitoring, alerting, risk assessment or crisis management 
these  are  addressed  in  the  Decision.  In  order  to  address  the  gaps,  the  Decision  requires  the 
Member  States  to  coordinate  their  preparedness  efforts,  extends  the  early  warning  and 
response  system  to  cover  all  serious  cross-border  threats  to  health,  provides  for  coordinated 
public health risk assessment by bringing together risk assessments and stressing their public 
health  aspects,  adds  monitoring  requirements  in  a  crisis  for  threats  to  health  other  than 
communicable diseases and, finally, provides for a crisis management structure for addressing 
health threats. 

2. 

RESULTS OF CONSULTATIONS WITH INTERESTED PARTIES 

2.1. 

Consultation with interested parties and use of expertise 

The  open  stakeholder  consultation  on  health  security  in  the  European  Union  took  place 
between  4  March  and  31  May  2011.  In  all  75  responses  to  the  online  questionnaire  were 
received: 21 on behalf of national, regional or local authorities, 31 on behalf of organisations 
and 23 from individual citizens20. 

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Council  Directive  96/82/EC  of  9  December  1996  on  the  control  of  major-accident  hazards  involving 
dangerous substances (OJ L 10, 14.1.1997, p. 13) 
Directive 2008/50/EC of the European Parliament and of the Council of 21 May 2008 on ambient air 
quality and cleaner air for Europe (OJ L152, 11.6.2008, p.1)  
Report on the Stakeholder Consultation on Heath Security in the European Union: 
http://ec.europa.eu/health/preparedness_response/docs/healthsecurity_report_en.pdf 

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The key outcome of these stakeholder consultations is that most stakeholders are strongly in 
favour  of  having  all  serious  cross-border  health  threats  included  in  the  EU  health  security 
policy21. 

The Health Security Committee was consulted six times on the initiative. The EWRS network 
discussed the health security initiative at their meeting in February 2011. The European office 
of  the  World  Health  Organisation  is  represented  on  both  committees  as  an  observer.  In 
addition,  bilateral  meetings  with  six  Member  States  were  held  at  their  request  and  the 
initiative was also presented to the EU Health Policy Forum on 19 May 2011. 

Adding  to  the  expertise  of  the  Member  States,  the  European  Centre  for  Disease  Prevention 
and Control provided useful input as regards the scientific risk assessment issues. 

2.2. 

Impact assessment 

The Commission has carried out detailed analysis of three options: 

– 

– 

– 

Option 1: Status quo: maintaining the current level of activities; 

Option 2: Separate and different handling of serious cross-border threats to health — 
enhanced EU cooperation  through the use of soft instruments based on a voluntary 
approach; 

Option  3:  Establishing  a  common  EU  legal  framework  covering  all  serious  cross-
border threats to health through improved cooperation and legally binding measures. 

The results of the analysis led to the conclusion that option 3 has the strongest positive health 
impacts as it improves the protection of citizens against serious cross-border threats to health. 
It proposes a comprehensive framework for health security structures and systems including 
obligations on Member States in terms of preparedness and response planning. 

The  EU  added  value  will  be  increased  through  streamlining  and  coordinating  all  aspects  of 
preparedness  and  response  planning,  risk  assessment  and  risk  management  by  setting  up 
strategic  and  technical-level  cooperation  on  health  security  at  EU  level.  This  would  be 
guaranteed  by  the  establishment  of  a  sound  legal  basis  for  all  serious  cross-border  health 
threats.  By  also  providing  a  legal  basis  for  operating  a  joint  procurement  mechanism  for 
medical  countermeasures,  this  option  would  help  strengthen  the  preparedness  and  response 
capacity to deal with cross-border health threats across the EU. 

In the  Member States, administrative savings in  public  health risk management will also be 
achieved through enhanced coordination under the Health Security Committee, which allows 
pooling and exchange of expertise. 

21 

Please see the outcome of the consultation in the impact assessment report 

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3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

Legal basis 

With  the  entry  into  force  of  the  Lisbon  Treaty,  the  Union  has  been  empowered  to  support, 
coordinate  or  supplement  the  action  of  Member  States  in  the  area  of  the  protection  and 
improvement of human health (Article 6(a) TFEU). The Treaty also states that Union action 
must be directed towards improving public health, preventing physical and mental illness and 
diseases, and obviating sources of danger to physical and mental health; in particular, it must 
cover  ‘monitoring,  early  warning  of  and  combating  serious  cross-border  threats  to  health’ 
(Article  168(1)  TFEU).  EU  action  should,  however,  exclude  any  harmonisation  of  the  laws 
and regulations of the Member States and respect their responsibility for the definition of their 
health policy and for the organisation and delivery of health services and medical care. 

Furthermore,  the  Union  should  take  into  account  requirements  linked  to  a  high  level  of 
protection  of  human  health  while  defining  and  implementing  its  policies  and  activities 
(Article 9 TFEU). The principle of ‘health in all policies’ is particularly relevant in the multi-
sectoral context due to the transnational dimension of serious cross-border threats to health. 

At  international  level,  a  comprehensive  framework  on  health  security  exists  since  15  June 
2007  in  the  form  of  the  International  Health  Regulations  which  have  been  ratified  by  all 
Member States. 

3.2. 

Subsidiarity 

Serious cross-border threats to health and public health emergencies of international concern 
have, by their nature, transnational implications. In a globalised society, people and goods are 
moving  across  borders  and  illnesses  and  contaminated  products  can  circulate  within  hours 
across the globe. Public health measures therefore need to be consistent with each other and 
coordinated to contain further spread and minimise the consequences of such threats. 

Measures taken by an individual Member State to respond to such threats may touch upon the 
competences of the EU or other national governments, and can therefore damage the interests 
of Member States and run counter to the fundamental principles and goals of the EU if they 
are  not  consistent  with  each  other  and  are  not  based  on  shared  scientifically  objective  and 
comprehensive risk assessment. As an example, the lack of coordination at EU level in the E. 
coli outbreak in 2011 led to loss of life and economic loss for the food industry and also had 
consequences for trade. With respect to the H1N1 pandemic in 2009, there was a drastic drop 
in  medication  compliance  for  pandemic  vaccines,  potentially  endangering  the  health  of 
citizens, including health care workers, and jeopardising the capacity of the health sector to 
efficiently  respond  to  that  crisis.  In  addition,  the  pandemic  led  to  economic  losses  for  the 
Member  States’  budgets  due  to  unused  vaccines,  resulting  from  the  different  public 
perceptions both about the severity of the threat and the safety and efficacy of those products. 
Furthermore,  measures  that  are  effective  from  a  public  health  standpoint  (e.g.  isolation, 
quarantine,  social  distancing,  workplace  and  school  closures,  travel  advice  and  border 
controls) can have adverse consequences for civil liberties and the internal market. Therefore, 
the coordination of the response at Union level should ensure that measures taken at national 
level are proportionate and limited to public health risks related to serious cross-border health 
threats, and do not conflict with obligations and rights laid down in the Treaty, such as those 
relating  to  the  restriction  of  travel  and  trade.  Preparedness  measures  would  need  to  pay 
particular attention to protecting workers potentially exposed to the threat. 

EN 

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Since the objectives of the action to be taken cannot be sufficiently achieved by the Member 
States alone due to the cross-border aspects of those threats and can therefore, for reasons of 
effectiveness, be better achieved at EU level, the EU 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,  the  proposed 
Decision does not go beyond what is necessary in order to achieve those objectives. 

The  proposal  builds  on  positive  experience  with  coordination  in  the  field  of  communicable 
diseases,  and  proposes  extending  the  existing  systems  and  applying  the  lessons  learnt  to 
ensure that citizens enjoy equal protection against all health hazards. 

For the purpose of achieving the objectives, the Commission should be empowered to adopt 
delegated  acts  in  accordance  with  Article  290  of  the  Treaty  on  the  Functioning  of  the 
European Union, in order to supplement or amend certain non-essential elements of the basic 
act. 

In  order  to  achieve  uniform  conditions  for  the  implementation  of  the  basic  act,  particularly 
with  regard  to  the  procedures  for  information  sharing,  consultation  and  coordination  of 
preparedness  and  response,  the  Commission  should  be  empowered  to  adopt  implementing 
acts in accordance with Article 291 of the Treaty on the Functioning of the European Union. 

4. 

BUDGETARY IMPLICATIONS 

This legal proposal does not impact on decentralised agencies. 

In  addition,  the  current  EU  health  programme  already  covers  some  activities  in  relation  to 
monitoring,  alerting  and  risk  assessment  of  some  health  threats.After  2013  the  Commission 
intends to cover these activities under the proposed Health for growth programme 2014-2020. 
The cost is included in the proposed envelope of the new programme. 

The joint procurement, as a voluntary mechanism, may have a budgetary impact in case the 
EU Institutions were to participate as a Contracting Authority for the procurement of medical 
countermeasures to cover EU staff. Member States remain responsible for procuring medical 
countermeasures to cover their citizens. 

The  budgetary  implications  for  EU  institutions  are  difficult  to  forecast  as  it  depends  on  the 
type of medical countermeasure that is procured, the staff coverage pursued, and, in the case 
of  pandemic  influenza,  the  unknown  characteristics  of  the  next  pandemic  influenza  virus  in 
terms of whether 1 or 2 vaccine doses will be required to achieve immunity. The expenditure 
should be covered within the medical expenditure foreseen by each institution. 

During the 2009 influenza H1N1 pandemic, 10,000 doses of pandemic influenza vaccine were 
bought by the EU institutions at a price of 6 euro per dose. For Commission staff 5,000 doses 
were  reserved  of  which  3,000  were  administered  (vaccination  was  offered  on  a  voluntary 
basis).  The  Medical  Service  envisages  a  similar  approach  for  an  eventual  future  influenza 
pandemic. In the case of a serious pandemic where a higher number of staff may wish to get 
vaccinated, it is envisaged that staff is vaccinated through the health care services of the host 
country. In conclusion, it is expected that the budgetary implication of vaccine procurement 
for a future pandemic will be similar to the situation in 2009. 

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2011/0421 (COD) 

Proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on serious cross-border threats to health  

(Text with EEA relevance) 

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, paragraphs (4)(c) and (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 Committee1, 

Having regard to the opinion of the Committee of the Regions2, 

Having regard to the opinion of the European Data Protection Supervisor3,  

Acting in accordance with the ordinary legislative procedure4, 

Whereas: 

(1) 

Article 168 of the Treaty on the Functioning of the European Union states, inter alia, 
that  the  Union's  action  in  the  field  of  public  health  should  cover  monitoring,  early 
warning of and combating serious cross-border threats to health, and that a high level 
of human health protection is to be ensured in the definition and implementation of all 
Union policies and activities. According to the same provision, Member States must, 
in  liaison  with  the  Commission,  coordinate  among  themselves  their  policies  and 
programmes in the areas covered by the Union action in the field of public health. 

(2) 

By  Decision  No  2119/98/EC  of  the  European  Parliament  and  of  the  Council  of  24 
September  19985  a  network  on  the  epidemiological  surveillance  and  control  of 
communicable  diseases  in  the  Community  was  set  up.  Experience  gained  in  the 

1 
2 
3 
4 

5 

OJ C , , p.  
OJ C , , p. 
OJ C , , p. 
Position  of  the  European  Parliament  of  5  July  2011  (not  yet  published  in  the  Official  Journal)  and 
decision of the Council of 27 July 2011 
OJ L 268, 3.10.1998, p.1 

EN 

11 

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(3) 

(4) 

(5) 

(6) 

(7) 

implementation  of  that  Decision  confirms  that  coordinated  Union  action  on 
monitoring, early warning of and combating those threats adds value to the protection 
and improvement of human health. However, a number of developments at Union and 
international level in the past decade make a review of that legal framework necessary. 

Apart  from  communicable  diseases,  a  number  of  other  sources  of  danger  to  health, 
notably  related  to  other  biological  agents,  chemical  agents  or  environmental  events, 
which  include  hazards  related  to  climate  change,  may,  by  reason  of  their  scale  or 
severity, endanger the health of citizens in the entire Union, lead to the malfunctioning 
of  critical  sectors  of  society  and  economy  and  jeopardise  individual  Member  State's 
capacity  to  react.  Therefore,  the  legal  framework  set  up  under  Decision  No 
2119/98/EC  should  be  extended  to  cover  these  other  threats  and  provide  for  a 
coordinated wider approach to health security at Union level. 

An  important  role  in  the  coordination  of  recent  crises  of  Union  relevance  has  been 
played by the Health Security Committee, an informal group composed of high level 
representatives  from  Member  States  and  established  on  the  basis  of  the  Presidency 
Conclusions  of  15  November  2001  on  bioterrorism6.  It  is  necessary  to  integrate  this 
group  into  a  formalised  institutional  framework  and  to  assign  it  a  well-defined  role 
avoiding duplications with other Union entities responsible for risk management, not 
least that established under Decision No 2119/98/EC. 

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  Control7 
(ECDC) provides the ECDC with a mandate covering surveillance, detection and risk 
assessment of threats to human health from communicable diseases and outbreaks of 
unknown  origin.  The  ECDC  has  progressively  taken  over  the  epidemiological 
surveillance  of  communicable  diseases  and  the  operation  of  the  Early  Warning  and 
Response  System  from  the  Community  network  set  up  under  Decision  No 
2119/98/EC.  This  development  is  not  reflected  in  Decision  No  2119/98/EC,  which 
was adopted before the creation of the ECDC. 

The International Health Regulations (2005) adopted by the Fifty-eighth World Health 
Assembly  on  23  May  2005  reinforced  the  coordination  among  States  Parties  to  the 
World  Health  Organisation  (WHO),  which  include  all  the  Member  States  of  the 
Union,  of  the  preparedness  for  and  response  to  a  public  health  emergency  of 
international concern. The legislation of the Union should take this development into 
account,  including  the  integrated  all-hazards  approach  of  the  WHO  covering  all 
categories of threats independently of their origin. 

This Decision should not apply to the serious cross-border health threats arising from 
ionizing radiation, as those threats are already covered by Article 2(b) and Chapter 3 
of Title II of the Treaty establishing the European Atomic Energy. Moreover, it should 
apply  without  prejudice  to  other  binding  measures  concerning  specific  activities  or 
setting  the  standards  of  quality  and  safety  of  some  goods,  which  provide  for  special 
obligations and tools for monitoring, early warning and combating specific threats of 
cross-border nature. 

6 
7 

13826/01 
OJ L 142, 30.4.2004, p.1 

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12 

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(8) 

(9) 

Preparedness and response planning is an essential element allowing for an effective 
monitoring,  early  warning  of  and  combating  serious  cross-border  threats  to  health. 
Such planning should include in particular adequate preparedness of critical sectors of 
society such as energy, transport, communication or civil  protection  which rely, in a 
crisis situation, on well-prepared public health systems that are also in turn dependent 
on  the  functioning  of  those  sectors  and  on  maintenance  of  essential  services  at  an 
adequate level. 

The  International  Health  Regulations  (2005)  already  require  Member  States  to 
develop, strengthen and maintain their capacity to detect, assess, notify and respond to 
a public health emergency of international concern. Coordination between the Member 
States  is  necessary  to  achieve  a  consistent  level  of  preparedness  and  interoperability 
between  national  preparedness  plans  in  view  of  the  international  standards,  while 
respecting Member States' competence to organise their health systems. 

(10)  The  European  Parliament  in  its  resolution  of  8  March  20118  and  the  Council  in  its 
Conclusions  of  13  September  20109  stressed  the  need  to  introduce  a  common 
procedure for the joint procurement of medical countermeasures, and in particular of 
pandemic vaccines, to allow Member States, on a voluntary basis, to benefit from such 
group  purchases.  With  regard  to  pandemic  vaccines,  in  the  context  of  limited 
production capacities at global level, such a procedure would increase the availability 
of those products and ensure fairer access to them among Member States participating 
in the joint procurement. 

(11)  Contrary  to  communicable  diseases,  whose  surveillance  at  the  Union  level  is  carried 
out on a permanent basis by the ECDC, other serious cross-border threats to health do 
not  currently  necessitate  a  systematic  monitoring.  A  risk-based  approach,  whereby 
monitoring  networks  are  set  up  ad  hoc  and  on  a  temporary  basis,  is  therefore  more 
appropriate to those other threats. 

(12)  A system enabling the notification at the Union level of alerts related to serious cross-
border threats to health should be put in place in order to ensure that competent public 
health  authorities  in  Member  States  and  the  Commission  are  duly  and  timely 
informed.  Therefore,  the  Early  Warning  and  Response  System  (EWRS),  established 
under Decision No 2119/98/EC for communicable diseases, should be extended to all 
the  serious  cross-border  threats  to  health  covered  by  the  present  Decision.  The 
notification  of  an  alert  should  be  required  only  where  the  scale  and  severity  of  the 
threat  concerned  are  or  may  become  so  significant  that  the  coordination  of  the 
response at the Union level is necessary. 

(13) 

In order to ensure that the assessment of risks to public health at the Union level from 
serious  cross-border  threats  to  health  is  consistent  as  well  as  comprehensive  from  a 
public  health  perspective,  the  available  scientific  expertise  should  be  mobilised  in  a 
coordinated manner, through appropriate channels or structures depending on the type 
of threat concerned. This risk assessment should be based on robust scientific evidence 
and independent expertise and provided by the Agencies of the Union in accordance 
with their missions, or otherwise by expert groups set up by the Commission. 

8 
9 

2010/2153(INI) 
12665/10 

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13 

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(14)  Effectively  responding  to  serious  cross-border  threats  to  health  at  national  level 
requires  a  consistent  approach  among  Member  States,  in  conjunction  with  the 
Commission, necessitating exchange of information, consultation and coordination of 
actions.  Under  Decision  No  2119/98/EC,  the  Commission  already  coordinates  the 
response  at  the  Union  level  in  collaboration  with  Member  States  with  regard  to 
communicable diseases. A similar mechanism should apply to all serious cross-border 
threats  to  health  independently  of  their  origin.  It  should  also  be  recalled  that, 
independently from this Decision, a Member State may, in case of a major emergency, 
request  assistance  under  Council  Decision  of  8  November  2007  establishing  a 
Community Civil Protection Mechanism (2007/779/EC, Euratom)10. 

(15)  Measures taken by individual Member States to respond to such threats may damage 
the interests of other Member States if they are not consistent with one another, or not 
based on shared and solid risk assessment. They may also conflict with competences 
of  the  Union  or  with  fundamental  rules  of  the  Treaty  on  the  Functioning  of  the 
European Union. Therefore, the coordination of the response at the Union level should 
ensure inter alia that measures taken at national level are proportionate and limited to 
public health risks related to serious cross-border threats to health, and do not conflict 
with  obligations  and  rights  laid  down  in  the  Treaty,  such  as  those  related  to  the 
restriction of travel and trade. 

(16) 

Inconsistent  or  confusing  communication  with  the  public  and  stakeholders  such  as 
health professionals may have a negative impact on the effectiveness of the response 
from  a  public  health  perspective  as  well  as  on  economic  operators.  Therefore,  the 
coordination of the response at the Union level should encompass shared information 
campaigns  and  consistent  communication  messages  to  citizens  based  on  robust  and 
independent evaluation of public health risks. 

(17)  The  applicability  of  some  specific  provisions  of  Commission  Regulation  (EC)  No 
507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal 
products for human use falling within the scope of Regulation (EC) No 726/2004 of 
the  European  Parliament  and  of  the  Council11  and  Commission  Regulation  (EC)  No 
1234/2008  of  24  November  2008  concerning  the  examination  of  variations  to  the 
terms of marketing authorisations for medicinal products for human use and veterinary 
medicinal products12, depends on the recognition at Union level in the framework of 
Decision  2119/98/EC,  of  an  emergency  situation  or  of  a  pandemic  situation  with 
respect  to  human  influenza.  Those  provisions  allow  for  the  accelerated  marketing  of 
certain  medicinal  products  in  case  of  urgent  needs,  by  means,  respectively,  of  a 
conditional  marketing  authorisation  and  of  the  temporary  possibility  to  grant  a 
variation to the terms of a marketing authorisation for a human influenza vaccine even 
where certain non-clinical or clinical data are missing. However, in spite of the utility 
of  such  provisions  in  the  event  of  a  crisis,  there  is  to  date  no  specific  procedure  for 
issuing such recognitions at Union level. It is therefore appropriate to provide for such 
a procedure as part of the standards of quality and safety for medicinal products. 

10  
11 
12 

OJ L 314, 1.12.2007, p. 9. 
OJ L 92, 30.3.2006, p.6 
OJ L 334, 12.12.2008, p.7 

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(18)  The processing of personal data for the purpose of implementing this Decision should 
comply with Directive 95/46/EC of the European Parliament and of the Council of 24 
October  1995  on  the  protection  of  individuals  with  regard  to  the  processing  of 
personal  data  and  on  the  free  movement  of  such  data13  and  Regulation  (EC)  No 
45/2001 of the European Parliament and of the Council of 18 December 2000 on the 
protection  of  individuals  with  regard  to  the  processing  of  personal  data  by  the 
Community  institutions  and  bodies  and  on  the  free  movement  of  such  data14.  In 
particular,  the  operation  of  the  Early  Warning  and  Response  System  should  provide 
for  specific  safeguards  allowing  safe  and  lawful  exchange  of  personal  data  for  the 
purpose of contact tracing measures implemented by Member States at national level.  

(19)  Since the objectives of this Decision cannot  be sufficiently achieved by the Member 
States alone due to the cross-border dimension of those threats 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  of  the  Treaty  on  European  Union.  In 
accordance  with  the  principle  of  proportionality,  as  set  out  in  that  Article,  this 
Decision does not go beyond what is necessary in order to achieve those objectives. 

(20)  The power to adopt delegated acts in accordance with the Article 290 of the Treaty on 
the  functioning  of  the  European  Union  should  be  conferred  to  the  Commission  in 
respect  of  measures  needed  to  complement  the  action  of  the  Member  States,  in  very 
specific  and  urgent  situations,  for  the  transnational  aspects  of  the  control  of  serious 
cross-border threats to health. It is of particular importance that the Commission carry 
out appropriate consultations during its preparatory work, including at expert level, as 
far  as  the  urgency  of  the  situation  allows  it.  The  Commission,  when  preparing  and 
drawing  up  delegated  acts,  should  ensure  simultaneous,  timely  and  appropriate 
transmission of relevant documents to the European Parliament and to the Council. 

(21) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Decision, 
implementing powers should be conferred on the Commission to adopt implementing 
acts  in  relation  to:  the  procedures  for  the  coordination,  the  exchange  of  information 
and the mutual consultation on preparedness and response planning; the adoption of a 
list of communicable diseases subject to the network of epidemiological surveillance 
and the procedures for the operation of such a network; the setting up and termination 
of ad hoc monitoring networks and the procedures for the operation of such networks; 
the  adoption  of  case  definitions  for  serious  cross-border  threats  to  health;  the 
procedures  for  the  operation  of  the  Early  Warning  and  Response  System;  the 
procedures for the coordination of the responses of the Member States; the recognition 
of situations of emergency at Union level or of pre-pandemic situations with respect to 
human  influenza  at  Union  level.  Those  implementing  powers  should  be  exercised  in 
accordance with Regulation (EU) No 182/2011 of the European Parliament and of the 
Council of 16 February 2011 laying down the rules and general principles concerning 
mechanisms  for  control  by  Member  States  of  the  Commission's  exercise  of 
implementing powers15. 

13 
14 
15 

OJ L 281, 23.11.1995, p. 31 
OJ L 8, 12.1.2001, p. 1. 
OJ L 55, 28.2.2011, p.13 

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(22) 

In  order  to  enhance  clarity  and  legal  certainty,  Decision  No  2119/98/EC  should  be 
repealed and replaced by this Decision. 

HAVE ADOPTED THIS DECISION 

Chapter I 
General provisions  

Article 1 
Subject matter 

1. 

2. 

This  Decision  lays  down  rules  on  monitoring,  early  warning  of  and  combating 
serious  cross-border  threats  to  health,  as  well  as  on  preparedness  and  response 
planning related to those activities. 

This  Decision  aims  to  support  the  prevention  and  control  of  the  spread  of  severe 
human diseases across the borders of the Member States, and to obviate other major 
sources of serious cross-border threat to health in order to contribute to a high level 
of public health protection in the Union. 

Article 2 
Scope 

1. This Decision shall apply in case of serious cross-border threats to health falling within the 
following categories: 

(a) threats of biological origin, consisting of: 

(i) communicable diseases; 

(ii)  antimicrobial  resistance  and  healthcare-associated  infections  related  to  communicable 
diseases (hereinafter referred to as " the related special health issues") ;  

(iii) biotoxins or other toxic biological agents not related to communicable diseases; 

(b) threats of chemical origin  with the exception of threats arising from ionizing radiation; 

(c)  threats  of  environmental  origin,  including  threats  deriving  from  the  effects  of  climate 
change;  

(d) threats of unknown origin; 

(e)  events  which  may  constitute  public  health  emergencies  of  international  concern 
determined  pursuant  to  the  International  Health  Regulations  (2005),  provided  that  they  fall 
under one of the categories of threats set out in points (a) to (d). 

2. This Decision  shall apply  without  prejudice to measures on monitoring, early warning of 
and combating serious cross-border threats to health as well as the requirements concerning 
preparedness and response planning provided for in other binding Union provisions, including 

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measures setting standards of quality and safety for specific goods and measures concerning 
specific economic activities.  

3.  The  Commission  shall,  where  appropriate  and  in  liaison  with  the  Member  States,  ensure 
coordination  and  mutual  information  between  the  mechanisms  and  structures  established 
under this Decision and similar mechanisms and structures established at Union level whose 
activities  may  be  relevant  for  the  monitoring,  early  warning  and  combating  serious  cross-
border threats to health. 

Article 3 
Definitions 

For the purpose of this Decision, the following definitions shall apply: 

(a) ‘case definition’ means a set of commonly agreed diagnostic criteria that must be fulfilled 
in order to accurately detect cases of a targeted serious cross-border threat to health in a given 
population, while excluding the detection of other similar threats; 

(b) ‘communicable disease’ means an infectious disease caused by a contagious agent which 
may be transmitted from person to person by direct contact with an affected individual or by 
an indirect means such as exposure to a vector, fomite, product or environment, or exchange 
of fluid, contaminated with the contagious agent; 

(c) ‘contact tracing’ means measures implemented at national level in order to trace persons 
who  have  been  exposed  to  a  source  of  a  serious  cross-border  threat  to  health,  and  who  are 
potentially in danger of developing or have developed a disease; 

(d)  ‘epidemiological  surveillance’  means  the  prompt  and  systematic  collection,  recording, 
analysis, interpretation and dissemination of data and analysis on communicable diseases and 
related special health issues, including data reflecting the current health status of a community 
or  population,  and  systematic  threat  detection  for  the  purpose  of  directing  public  health 
action; 

(e)  ‘monitoring’  means  the  continuous  observation,  surveillance,  detection  or  reviewing  of 
changes in a condition, or situation, or changes in activities, including a continuous function 
that uses systematic collection of data and analysis on specified indicators relating to serious 
cross-border threats to health; 

(f) ‘public health measure’ means a decision or an activity which aims to prevent or control 
diseases, or to obviate sources of risks to public health or to mitigate their impact on public 
health; 

(g)  ‘serious  cross-border  threat  to  health’  means  a  hazard  of  biological,  chemical, 
environmental or unknown origin which is likely to spread across national borders of Member 
States and which may cause a potential severe risk to public health necessitating a coordinated 
action at the Union level;  

(h) ‘severe risk to public health’ means a likelihood of a hazard that may result in death, be 
life-threatening, cause a severe disease in exposed humans, or produce a congenital defect. 

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Chapter II 
Planning  

Article 4 
Preparedness and response planning 

1.  Member  States  shall,  in  liaison  with  the  Commission  and  on  the  basis  of  its 
recommendations, within the Health Security Committee referred to in Article 19, coordinate 
their  efforts  to  develop,  strengthen  and  maintain  their  capacities  for  the  monitoring,  early 
warning  and  assessment  of  and  response  to  the  serious  cross-border  threats  to  health.  That 
coordination shall in particular address the following issues: 

(a) the interoperability of national preparedness plans;  

(b) the consistent implementation of core capacity requirements for surveillance and response 
as referred to in Articles 5 and 13 of the International Health Regulations (2005). 

2.  For  the  purpose  of  paragraph  1,  Member  States  shall  provide  the  Commission  with  the 
following  information  concerning  the  state  of  play  of  their  preparedness  and  response 
planning: 

(i) minimum core capacity standards determined at national level for the health sector; 

(ii)  specific  mechanisms  established  at  national  level  for  the  interoperability  between  the 
health sector and other critical sectors of society; 

(iii) business continuity arrangements in critical sectors of society.  

3.  The  Commission  shall  make  the  information  referred  to  in  paragraph  2  available  to  the 
members of the Health Security Committee. 

4. Before adopting or reviewing their national preparedness plan, Member States shall consult 
each  other  and  the  Commission  in  relation  to  the  issues  referred  to  in  points  (a)  and  (b)  of 
paragraph 1. 

5. The Commission shall, by means of implementing acts, determine the procedures necessary 
for the coordination, the exchange of information and the mutual consultation referred to in 
paragraphs 1 to 4. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 20(2).  

Article 5 
Joint procurement of medical countermeasures 

1. The institutions of the Union and any Member States which so desire may engage in a joint 
procurement  procedure  conducted  pursuant  to  the  third  subparagraph  of  Article  91(1)  of 

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Council  Regulation  (EC,  Euratom)  No  1605/2002  of  25  June  2002  on  the  Financial 
Regulation applicable to the general budget of the European Communities16 and Article 125c 
of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down 
detailed rules for the implementation of the Council Regulation (EC, Euratom) No 1605/2002 
on the Financial Regulation applicable to the general budget of the European Communities17, 
with a view to the advance purchase of medical countermeasures against serious cross-border 
threats to health. 

2. The joint procurement procedure referred to in paragraph 1 shall comply with the following 
conditions: 

(a) participation in the joint procurement shall be open to all Member States until the launch 
of the procedure;  

(b) rights and obligations of Member States not participating in the joint procurement shall be 
respected, in particular those relating to the protection and improvement of human health; 

(c)  the  joint  procurement  shall  not  affect  the  internal  market,  shall  not  constitute 
discrimination or a restriction of trade and shall not cause distortions of competition. 

3.  The  joint  procurement  procedure  shall  be  preceded  by  a  Joint  Procurement  Agreement 
between  the  Parties  determining  the  practical  arrangements  governing  that  procedure,  in 
particular  the  order  of  priority  for  deliveries  between  the  Parties,  and  the  decision-making 
process  with  regard  to  the  choice  of  the  procedure,  the  assessment  of  the  tenders  and  the 
award of the contract. 

Chapter III 
Permanent surveillance and ad hoc monitoring 

Article 6 
Epidemiological surveillance  

1.  A  network  for  the  epidemiological  surveillance  of  the  communicable  diseases  and  of  the 
related special health issues referred to in Article 2(1)(a)(i) and (ii), is hereby established. 

2.  The  epidemiological  surveillance  network  shall  bring  into  permanent  communication  the 
Commission,  the  European  Centre  for  Disease  Prevention  and  Control,  and  the  competent 
authorities responsible at national level for collecting information relating to epidemiological 
surveillance. 

3.  National  competent  authorities  shall  collect  comparable  and  compatible  data  and 
information  in  relation  to  the  epidemiological  surveillance  and  without  delay  communicate 
them to the epidemiological surveillance network. 

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17 

OJ L 248, 16.9.2002, p.1 
OJ L 357, 31.12.2002, p.1 

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4.  When  reporting  information  on  epidemiological  surveillance,  the  national  competent 
authorities  shall  use  the  case  definitions  adopted  in  accordance  with  paragraph  5  for  each 
communicable disease and related special health issue referred to in paragraph 1. 

5. The Commission shall, by means of implementing acts, establish and update: 

(a) in order to ensure an exhaustive coverage by the epidemiological surveillance network, the 
list of communicable diseases referred to in Article 2 (1) (a)(i); 

(b) in order to ensure at Union level the comparability and compatibility of the collected data, 
case  definitions  related  to  each  communicable  disease  and  special  health  issue  subject  to 
epidemiological surveillance; 

(c) procedures for the operation of the epidemiological surveillance network as developed in 
application of Articles 10 and 11 of Regulation (EC) No 851/2004. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 20(2). 

On duly justified imperative grounds of urgency related to the severity or novelty of a serious 
cross-border threat to health or to the rapidity of its spread between the Member States, the 
Commission  may  adopt  the  measures  referred  to  in  points  (a)  and  (b)  through  immediately 
applicable implementing acts in accordance with the urgency procedure referred to in Article 
20(3). 

Article 7 
Ad hoc Monitoring Networks 

1. Following an alert pursuant to Article 9 concerning a threat to health referred to in points 
(a)(iii), (b), (c) or (d) of Article 2(1), the Member States shall, on the basis of the available 
information  from  their  monitoring  systems,  inform  each  other,  in  liaison  with  the 
Commission, through an ad hoc monitoring network set up pursuant to paragraph 3 as regards 
the developments of the situation related to the threat concerned at national level. 

2. The information transmitted pursuant to paragraph 1, shall include in particular any change 
in geographic distribution, spread and severity of the health threat concerned and of the means 
of detection. It shall be transmitted to the monitoring network by using, where applicable, the 
case definitions established in accordance with point (d) of paragraph 3. 

3. The Commission shall, by means of implementing acts: 

(a) set up, for the purposes of the cooperation referred to in paragraph 1, an ad hoc monitoring 
network  which  shall  bring  into  communication  the  Commission  and  the  national  contact 
points designated by the Member States in accordance with point (b) of Article 17(1) for the 
threat concerned; 

(b) terminate the operation of an ad hoc monitoring network when the conditions for notifying 
an alert in relation to the threat concerned, as laid down in Article 9(1) are no longer met; 

(c) adopt generic procedures for the operation of ad hoc monitoring networks; 

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(d) adopt, where necessary, the case definitions to be used for the ad hoc monitoring, in order 
to ensure at the Union level the comparability and compatibility of the collected data. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 20(2). 

On  duly  justified  imperative  grounds  of  urgency  related  to  the  severity  of  a  serious  cross-
border  threat  to  health  or  to  the  rapidity  of  its  spread  between  the  Member  States,  the 
Commission may set up an ad hoc monitoring network or adopt or update the case definitions 
referred to in point (d) through immediately applicable implementing acts in accordance with 
the urgency procedure referred to in Article 20(3). 

Chapter IV 
Early warning and response 

Article 8 
Establishment of an early warning and response system 

1.  A  rapid  alert  system  for  notifying  at  the  Union  level  alerts  in  relation  to  serious  cross-
border  threats  to  health,  ‘Early  Warning  and  Response  System’,  is  hereby  established.  This 
system  shall  bring  into  permanent  communication  the  Commission  and  the  competent 
authorities  responsible  at  national  level  for  alerting,  assessing  public  health  risks  and 
determining the measures that may be required to protect public health. 

2.  The  Commission  shall,  by  means  of  implementing  acts,  adopt  procedures  concerning  the 
information  exchange  in  order  to  ensure  the  proper  functioning  of  the  Early  Warning  and 
Response System and the uniform implementation of Articles 8 and 9. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 20(2). 

Article 9 
Alert notification 

1.  National  competent  authorities  or  the  Commission  shall  notify  an  alert  in  the  Early 
Warning  and  Response  System  where  the  emergence  or  development  of  a  serious  cross-
border threat to health fulfils the following conditions: 

(a)  it  is  unusual  or  unexpected  for  the  given  place  and  time,  or  it  causes  or  may  cause 
significant morbidity or mortality in humans, or it grows rapidly or may grow rapidly in scale, 
or it exceeds or may exceed national response capacity, and 

(b) it affects or may affect more than one Member State, and 

(c) it requires or may require a coordinated response at the Union level. 

2. Where the national competent authorities notify to the World Health Organization events 
that  may  constitute  public  health  emergencies  of  international  concern  in  accordance  with 
Article 6 of the International Health Regulations (2005), they shall at the latest simultaneously 

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notify an alert in the Early Warning and Response System, provided that the threat concerned 
falls within those referred to in Article 2(1) of this Decision. 

3.  When  notifying  an  alert,  the  national  competent  authorities  and  the  Commission  shall 
promptly  communicate  any  relevant  information  in  their  possession  that  may  be  useful  for 
coordinating the response, in particular on: 

(a) the type and origin of the agent, 

(b) the date and place of the incident or outbreak, 

(c) means of transmission or dissemination, 

(d) toxicological data, 

(e) detection and confirmation methods, 

(f) public health risks, 

(g) public health measures implemented or intended to be taken at national level, 

(h) measures other than public health measures, 

(i) personal data necessary for the purpose of contact tracing in accordance with Article 18. 

4.  The  Commission  shall  make  available  to  the  national  competent  authorities  through  the 
Early Warning and Response System any information that may be useful for coordinating the 
response  at  the  Union  level,  including  information  on  hazards  and  public  health  measures 
related to serious cross-border threats to health transmitted through other Union alert systems. 

Article 10 
Public health risk assessment 

Where an alert is notified pursuant to Article 9, the Commission shall, where it is necessary 
for the coordination of the response at Union level, make promptly available to the national 
competent  authorities  through  the  Early  Warning  and  Response  System  and  to  the  Health 
Security Committee referred to respectively in Articles 8 and 19 an assessment of the risks to 
public health. 

This assessment shall be based: 

(a) on the opinion of the European Centre for Disease Prevention and Control in accordance 
with Article 7(1) of Regulation (EC) No 851/2004; and/or 

(b)  on  the  opinion  the  European  Food  Safety  Authority  in  accordance  with  Article  23  of 
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 
2002  laying  down  the  general  principles  and  requirements  of  food  law,  establishing  the 

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European  Food  Safety  Authority  and  laying  down  procedures  in  matters  of  food  safety18; 
and/or 

(c)  where  the  assessment  needed  is  totally  or  partially  outside  the  mandates  of  the  above-
mentioned Agencies, on an ad hoc independent opinion. 

Article 11 
Coordination of response 

1.  Following  an  alert  pursuant  to  Article  9,  the  Member  States  shall,  on  the  basis  of  the 
available information, including risk assessments referred to in Article 10, consult each other 
within  the  Health  Security  Committee  referred  to  in  Article  19  and  in  liaison  with  the 
Commission  in  order  to  coordinate  national  responses  to  the  serious  cross-border  threat  to 
health,  including  where  a  public  health  emergency  of  international  concern  is  declared  in 
accordance with the International Health Regulations (2005) and falls within Article 2 of this 
Decision. 

2. Where a Member State intends to adopt public health measures to combat a serious cross-
border  threat  to  health,  it  shall,  before  adopting  those  measures,  consult  the  other  Member 
States and the Commission on the nature, purpose and scope of the measures, unless the need 
to protect public health is so urgent that the immediate adoption of the measures is necessary. 

3.  Where  a  Member  State  has  to  adopt,  as  a  matter  of  urgency,  public  health  measures  in 
response  to  the  appearance  or  resurgence  of  a  serious  cross-border  threat  to  health,  it  shall, 
immediately  upon  adoption,  inform  the  other  Member  States  and  the  Commission  on  the 
nature, purpose and scope of those measures. 

4.  In  the  event  of  a  serious  cross-border  health  threat  overwhelming  the  national  response 
capacities, an affected Member State may also request assistance from other Member States 
through  the  EU  Civil  Protection  Mechanism  established  by  Council  Decision  2007/779/EC, 
Euratom. 

5. The Commission shall, by means of implementing acts, adopt the procedures necessary for 
the  uniform  implementation  of  the  mutual  information,  consultation  and  coordination 
provided for in this Article. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 20(2). 

Article 12 
Common temporary public health measures 

1. Where the coordination of national responses provided for in Article 11 proves insufficient 
to control the spread of a serious cross-border threat to health between the Member States or 
to  the  Union,  and,  as  a  consequence,  the  protection  of  the  health  of  the  population  of  the 
Union as a whole is jeopardised, the Commission may complement the action of the Member 
States  through  the  adoption,  by  means  of  delegated  acts  in  accordance  with  the  procedure 

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provided for in Article 22, of common temporary public health measures to be implemented 
by the Member States. These measures may not concern the control of the threat concerned 
within each Member State. 

2.  Paragraph  1  shall  apply  only  to  serious  cross-border  health  threats  which  may  result  in 
deaths or hospitalisations on a large scale across the Member States. 

3. The measures adopted under paragraph 1 shall: 

(a) respect the responsibilities of the Member States for the definition of their health policy 
and for the organisation and delivery of health services and medical care; 

(b) be proportionate to the public health risks related to that threat, avoiding in particular any 
unnecessary restriction to the free movement of persons, of goods and of services; 

(c) be compatible with any applicable international obligation of the Union or of the Member 
States. 

Chapter V 
Emergency and pandemic influenza situations at the Union level 

Article 13 
Recognition of emergency situations or of pandemic influenza situations 

1. The Commission may, where the exceptional conditions laid down in paragraph 2 are met, 
formally recognise, by means of implementing acts: 

(a) situations of emergency at Union level; or 

(b) pre-pandemic situations with respect to human influenza at Union level. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 20(2). 

On  duly  justified  imperative  grounds  of  urgency  related  to  the  severity  of  a  serious  cross-
border threat to health or to the rapidity of its spread among Member States, the Commission 
may  formally  recognise  situations  of  emergency  at  Union  level  or  pre-pandemic  situations 
with respect to human influenza at Union level through immediately applicable implementing 
acts in accordance with the urgency procedure referred to in Article 20(3). 

2.  The  Commission  may  adopt  the  measures  referred  to  in  paragraph  1  only  when  all  the 
following conditions are met: 

(a)  the  Director-General  of  the  World  Health  Organization  has  not  yet  adopted  a  decision 
declaring the existence of a public health emergency of international concern in accordance 
with Articles 12 and 49 of the International Health Regulations (2005); 

(b) the serious cross-border health threat at issue: 

(i) can, by reasons of its nature, be prevented or treated by medicinal products; 

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(ii) is rapidly spreading within and across the Member States and endangers public health at 
the Union level; 

(iii) is life-threatening; 

(c)  the  medicinal  products,  including  vaccines,  already  authorised  at  Union  level  in 
accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council 
of 31 March 2004 laying down Community procedures for the authorisation and supervision 
of  medicinal  products  for  human  and  veterinary use and establishing a European Medicines 
Agency19 or in the Member States through the mutual recognition procedure or decentralized 
procedure referred to in Directive 2001/83/EC of the European Parliament and of the Council 
of 6 November 2001 on the Community code relating to medicinal products for human use20, 
are  not  or  may  not  be  sufficiently  efficient  for  the  prevention  or  treatment  of  the  threat 
concerned; 

(d) with a view to the formal recognition of a pre-pandemic situation with respect to human 
influenza at the Union level, the threat concerned is human influenza. 

Article 14 
Legal effects of the recognition 

1.  The  recognition  of  a  situation  of  emergency  at  the  Union  level  pursuant  to  point  (a)  of 
Article 13(1), shall have the sole legal effect of triggering the applicability of Article 2(2) of 
Regulation (EC) No 507/2006. 

2. The recognition of a pre-pandemic situation with respect to human influenza at the Union 
level  pursuant  to  point  (b)  of  Article  13(1)  shall  have  the  sole  legal  effect  of  triggering  the 
applicability of Article 2(2) of Regulation (EC) No 507/2006 and of Article 21 of Regulation 
(EC) No 1234/2008. 

Article 15 
Termination of the recognition  

The  Commission  shall,  by  means  of  implementing  acts,  terminate  the  recognition  of  the 
situations referred to in points (a) and (b) of Article 13(1) as soon as one of the conditions laid 
down in points (b), (c) and (d) of Article 13(2) is no longer met. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 20(2). 

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OJ L 136, 30.4.2004, p. 1 
OJ L 311, 28.11.2001, p. 67 

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Chapter VI 
International agreements 

Article 16 
International agreements 

The  Union  may  conclude  international  agreements  with  third  countries  or  international 
organisations  allowing  and  organizing  its  cooperation  with  those  third  countries  or 
international organisations on serious cross-border threats to health that pose particular risks 
of transmission to the population of the Union, in order to cover the following aspects: 

(a) exchange of good practice in the areas of preparedness and response planning, 

(b)  exchange  of  relevant  information  from  monitoring  and  alerting  systems,  including  the 
participation  of  the  countries  or  organisations  concerned  in  the  relevant  epidemiological 
surveillance or ad hoc monitoring networks and the Early Warning and Response System, 

(c) collaboration on the public health risk assessment of serious cross-border threats to health, 
with  special  reference  to  public  health  emergencies  of  international  concern  declared  in 
accordance with the International Health Regulations (2005), 

(d)  collaboration  on  response  coordination,  including  the  occasional  participation  of  the 
countries  or  organisations  concerned  in  the  Health  Security  Committee  as  observers,  with 
special reference to public health emergencies of international concern declared in accordance 
with the International Health Regulations (2005). 

Chapter VII 
Procedural provisions 

Article 17 
Designation of national authorities and representatives 

1.  Each  Member  State  shall  designate,  within  three  months  of  the  entry  into  force  of  this 
Decision: 

(a) the competent authorities responsible at national level for collecting information relating 
to epidemiological surveillance as referred to in Article 6; 

(b)  single  contact  points  for  the  purpose  of  the  coordination  of  the  ad  hoc  monitoring,  as 
referred to in Article 7; 

(c) the competent authority or authorities responsible at national level for notifying alerts and 
determining the measures required to protect public health, for the purposes of Articles 8, 9, 
and 10; 

(d) one representative and an alternate in the Health Security Committee referred to in Article 
19. 

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2. Member States shall notify the Commission and other Member States of the designations 
referred to in paragraph 1. 

3.  Each  Member  State  shall  notify  the  Commission  and  the  other  Member  States  of  any 
change in the information provided under paragraph 2. 

Article 18 
Protection of personal data 

1.  In  the  application  of  this  Decision,  personal  data  shall  be  processed  in  accordance  with 
Directive 95/46/EC and Regulation (EC) No 45/2001. 

2. The Early Warning and Response System shall include a selective messaging functionality 
allowing personal data to be communicated only to national competent authorities concerned 
by contact tracing measures. 

3. When competent authorities implementing contact tracing measures communicate personal 
data necessary for contact tracing purposes through the Early Warning and Response System 
pursuant  to  Article  9(3),  they  shall  use  the  selective  messaging  functionality  referred  to  in 
paragraph  2  of  this  Article  and  communicate  the  data  only  to  the  other  Member  States 
concerned by the contact tracing measures. 

4. When circulating the information referred to in paragraph 3, the competent authorities shall 
refer to the alert communicated previously to the Early Warning and Response System. 

5. Where a national competent authority establishes that a notification of personal data made 
by it pursuant to Article 9(3) has subsequently proved to be in breach of Directive 95/46/EC 
because  this  notification  was  not  necessary  for  the  implementation  of  the  contact  tracing 
measures  at  issue,  it  shall  inform  immediately  the  Member  States  to  which  this  notification 
was transmitted. 

6. The Commission shall adopt: 

(a)  guidelines  aiming  at  ensuring  that  the  day-by-day  operation  of  the  Early  Warning  and 
Response System complies with Directive 95/46/EC and Regulation (EC) No 45/2001; 

(b)  a  recommendation  providing  an  indicative  list  of  personal  data  that  may  or  should  be 
exchanged for the purpose of the coordination of contact tracing measures. 

Article 19 
Health Security Committee 

1. A ‘Health Security Committee’, composed of representatives  of Member  States  at  a  high 
level, is hereby established. 

2. The Health Security Committee shall have the following tasks: 

(a) support the exchange of information between the Member States and the Commission on 
the experience acquired with regard to the implementation of this Decision; 

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(b) assist the Commission in providing for the coordination of the preparedness and response 
planning efforts of the Member States in accordance with Article 4; 

(c) assist the Commission in providing for the coordination of the responses of the Member 
States to serious cross-border threats to health, in accordance with Article 11. 

3.  The  Health  Security  Committee  shall  be  chaired  by  a  representative  of  the  Commission. 
The  Health  Security  Committee  shall  meet  at  regular  intervals  and  whenever  the  situation 
requires, on a request from the Commission or a Member State.  

4. The secretariat shall be provided by the Commission. 

Article 20 
Committee on serious cross-border threats to health 

1. For the adoption of implementing acts, the Commission shall be assisted by the Committee 
on  serious  cross-border  threats  to  health.  That  Committee  shall  be  a  committee  within  the 
meaning of Article 3(2) of Regulation (EU) No 182/2011. 

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall 
apply. 

3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in 
conjunction with Article 5 thereof, shall apply. 

Article 21 

Exercise of the delegation 

1.  The  power  to  adopt  the  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

2.  The  power  to  adopt  delegated  acts  referred  to  in  Article  12  shall  be  conferred  on  the 
Commission for a period of five years after [...]21.The Commission shall draw up a report in 
respect of the delegation of power not later than nine months before the end of the five-year 
period. The delegation of power shall be tacitly extended for periods of an identical duration, 
unless  the  European Parliament  or  the  Council  opposes  such  extension  not  later  than  three 
months before the end of each period. 

3.  The  delegation  of  powers  referred  to  in  Article  12  may  be  revoked  at  any  time  by  the 
European  Parliament  or  by  the  Council.  A  decision  of  revocation  shall  put  an  end  to  the 
delegation of the powers specified in that decision. It shall take effect the day following the 
publication  of  the  decision  in  the  Official  Journal  of  the  European  Union  or  at  a  later  date 
specified therein. It shall not affect the validity of any delegated act already in force. 

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the 
European Parliament and to the Council. 

21 

OJ: Please insert the date: date of entry into force of this Decision 

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5. A delegated act adopted pursuant to Article 12 shall enter into force only if no objection 
has  been  expressed  either  by  the  European  Parliament  or  the  Council  within  a  period  of  2 
months of notification of that act to the European Parliament and the Council or if, before the 
expiry  of  that  period,  the  European  Parliament  and  the  Council  have  both  informed  the 
Commission  that  they  will  not  object.  That  period  shall  be  extended  by  2  months  at  the 
initiative of the European Parliament or the Council. 

Article 22 
Urgency procedure 

1.  Delegated  acts  adopted  under  this  Article  shall  enter  into  force  without  delay  and  shall 
apply as long as no objection is expressed in accordance with paragraph 2. The notification of 
a delegated act to the European Parliament and to the Council shall state the reasons for the 
use of the urgency procedure. 

2. Either the European Parliament or the Council may object to a delegated act in accordance 
with the procedure referred to in Article 21(5). In such a case, the Commission shall repeal 
the  act  without  delay  following  the  notification  of  the  decision  to  object  by  the 
European Parliament or by the Council. 

Article 23 
Reports concerning this Decision 

The Commission shall submit to the European Parliament and the Council every three years a 
technical  report  on  the  activities  of  the  Early  Warning  and  Response  System  and  other 
activities carried out in the context of the implementation of this Decision. 

Chapter VIII 
Final provisions 

Article 24 
Repeal of Decision 2119/98/EC 

1. Decision No 2119/98/EC is hereby repealed. 

2. References to the repealed Decision shall be construed as references to this Decision. 

Article 25 
Entry into force 

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

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Article 26 
Addressees 

This Decision is addressed to the Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX  

LEGISLATIVE FINANCIAL STATEMENT 

5. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

5.1. 

Title of the proposal/initiative  

Draft Decision of the European Parliament and of the Council on serious cross-border threats 
to health 

Policy area(s) concerned in the ABM/ABB structure1  

Union action in the field of health (17 03 06) 

Programme  of  the  European  Union  action  in  the  field  of  health  —  Expenditure  on 
administrative management (17 01 04) 

External  staff  and  other  management  expenditure  in  support  of  the  ‘Health  and  consumer 
protection’ policy area – Other management expenditure (17 01 02 11) 

Administrative  expenditure  of  the  'Commission's  administration'  policy  area  –  Personnel 
policy and management - Medical service (26 01 50 01) 

5.2. 

Nature of the proposal/initiative  

(cid:133) The proposal/initiative relates to a new action  

(cid:133) The proposal/initiative relates to a new action following a pilot project/preparatory action2  

(cid:59) The proposal/initiative relates to the extension of an existing action  

(cid:133) The proposal/initiative relates to an action redirected towards a new action  

5.3. 

Objectives 

5.3.1.  The Commission's multiannual strategic objective(s) targeted by the proposal/initiative  

HEALTH SECURITY 

The  general  objectives  of  this  initiative  are  to  improve  the  protection  of  the  citizens  of  the 
European Union from serious cross-border threats and to ensure a high level of human health 
protection in defining and implementing EU policies and activities. Capacities and structures 

1 
2 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 

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will  be  strengthened  and  measures  concerning  monitoring,  early  warning  of  and  combating 
serious cross-border threats to health as set out in Article 168 of the TFEU are envisaged. 

5.3.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned  

The specific objective of this initiative is to strengthen the response to all serious cross-border 
threats  to  health  (other  than  those  associated  with  radio  nuclear  events)  based  on  a 
comprehensive and coherent approach to preparedness and response planning, risk monitoring 
and assessment, as well as risk management including risk communication. 

Specific objective No. 1: 

As  regards  preparedness  and  response  planning,  the  specific  objective  is  to  develop  a 
common approach to preparedness planning at EU level for all serious cross-border threats to 
health,  ensuring  coherence  and  interoperability  among  sectors  at  EU  level  and  between 
Member  States.  This  includes  improving  equitable  access  to  medical  countermeasures  (e.g. 
pandemic influenza vaccines). 

ABM/ABB activity(ies) concerned 

Union action in the field of health (17 03 06) 

Programme  of  the  European  Union  action  in  the  field  of  health  —  Expenditure  on 
administrative management (17 01 04) 

Administrative  expenditure  of  the  'Commission's  administration'  policy  area  –  Personnel 
policy and management - Medical service (26 01 50 01)3 

Specific objective No. 2: 

In the area of risk monitoring and assessment the specific objective is to create conditions to 
ensure  a  coherent  and  comprehensive  identification  and  notification  of  health  threats  and 
evaluation  of  their  risks  to  health,  especially  in  the  case  of  health-related  crises  with  a 
multidisciplinary dimension. 

ABM/ABB activity(ies) concerned 

Union action in the field of health (17 03 06) 

Programme  of  the  European  Union  action  in  the  field  of  health  —  Expenditure  on 
administrative management (17 01 04) 

Specific objective No. 3: 

In the area of risk management the specific objective is to create conditions to strengthen and 
enhance coordination between Member States, the international level and the Commission in 

3 

Participation in the joint procurement of pandemic influenza vaccines for Commission staff. 

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order to ensure a coherent and consistent policy approach to effectively manage responses to 
serious cross-border threats to health across the EU. 

ABM/ABB activity(ies) concerned 

Union action in the field of health (17 03 06) 

External  staff  and  other  management  expenditure  in  support  of  the  ‘Health  and  consumer 
protection’ policy area – Other management expenditure (17 01 02 11) 

Specific objective No. 4: 

As  regards  risk  and  crisis  communication,  the  aims  of  the  initiative  will  be  to  create  and 
facilitate  shared  communication  strategies  and  messages  in  order  to  avoid  conflicting  or 
inaccurate information being released to the public. 

ABM/ABB activity(ies) concerned 

Union action in the field of health (17 03 06) 

Programme  of  the  European  Union  action  in  the  field  of  health  —  Expenditure  on 
administrative management (17 01 04) 

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33 

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5.3.3.  Expected result(s) and impact 

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

Public health impact. The protection of EU citizens against serious cross-border health threats 
and the effectiveness of public health security structures and mechanisms at EU level would 
be considerably improved. This would allow coherent preparedness planning based on shared 
and common mandatory standards and a better coordinated and balanced response to all types 
of  serious  cross-border  health  threats.  For  example,  all  Member  States  would  need  to  have 
preparedness plans in place that would cover both health measures and other critical sectors, 
and structures and capacities would need to be set up in compliance with agreed check lists. 
This  option  would  also  result  in  a  more  coherent  and  comprehensive  approach  to  the 
identification, notification and assessment of serious cross-border health threats. By setting up 
a  legal  basis  allowing  joint  procurement,  this  option  would  considerably  improve  equitable 
access  to  medical  countermeasures  by  Member  States,  thereby  ensuring  a  higher  level  of 
protection of EU citizens across the Union. Furthermore, inter-sectoral cooperation would be 
improved in the event of cross-border health threats, also contributing to better public health 
protection. 

Social  impact.  A  coordinated  approach  to  access  to  medical  countermeasures  would  raise 
confidence in measures undertaken by public health authorities, as they would rely on a robust 
legal instrument. For those Member States that had opted to participate in joint procurement, 
the mechanism would lead to a higher level of protection for vulnerable groups by ensuring a 
guaranteed  supply  and  would  promote  solidarity  between  the  Member  States  by  providing 
common minimum coverage for vulnerable groups of society. 

impact.  The  setting-up  of  a 

joint  procurement  mechanism  for  medical 
Economic 
countermeasures would boost the supply of medical products and encourage development of 
new products based on long-term contracts agreed with the public health sector. 

Financial impact. As regards preparedness, additional costs could be expected, particularly in 
relation  to  human  resources  and  the  provision  of  technical  equipment  in  the  Member  States 
and at EU level. In order to cover gaps in risk assessment, additional financial resources in the 
region of EUR 500,000 annually would be needed from the EU health programme to establish 
a framework contract so as to gain access to expert knowledge when needed. The aim would 
be to establish permanent networks of national correspondents between health authorities and 
agencies  competent  in  assessing  specific  threats.  However,  proposed  measures  relating  to 
enhanced  cooperation  would  have  no  substantial  financial  impacts,  because  they  would  be 
based on the existing mechanisms and structures in place. 

Administrative burden. Governance in public health risk management would be significantly 
improved, as only one expert committee would need to be operated. 

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34 

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Impact  at  international  level.  Better  coordination  in  the  EU  of  implementation  of  the 
International  Health  Regulations  (2005)4  by  the  Member  States  and  closer  collaboration 
between the EU and the WHO on preparedness for and response to public health emergencies 
of international concern would contribute to enhancing global health security. 

5.3.4. 

Indicators of results and impact  

Specify the indicators for monitoring implementation of the proposal/initiative. 

For the systematic follow-up of the policy measures in the field of preparedness and response 
planning,  risk  assessment  and  risk  management,  monitoring  and  evaluation  of  the 
implementation of the legislative instrument will be carried out as follows: 

The  Commission  will  submit  to  the  European  Parliament  and  the  Council  regular  reports 
evaluating the implementation of the legal act. The first report will be submitted following an 
evaluation which will be carried out within four years after the entry into force of the legal act. 

Evaluation  of  the  effective  operation  of  the  structures  and  mechanisms  provided  for  by  the 
Health Security Initiative will be based on information from Member States supplied annually, 
with scientific support from specialised agencies and organisations such as the ECDC or EMA 
to provide a basis for comparison and consistency in Commission reporting. 

The  main  instrument  for  gathering  data  for  the  purpose  of  such  an  evaluation  will  be  a 
reporting  system  that  will  be  approved  and  implemented  by  the  new  health  committee.  The 
competent authorities in the Member States, the European Centre of Disease Prevention and 
Control  and  the  Commission  will  cooperate  closely  to  develop  the  required  tools  and 
instruments. Involvement of other international bodies such as the World Health Organisation 
and the Global Health Security Initiative (GHSI)5 may be considered where appropriate. 

Reporting  will  cover  information  on  cooperation  mechanisms  established,  key  sectors 
involved and websites in place to share information on best practices. Key indicators for the 
monitoring as well as the evaluation of policy implementation and outcomes are set out below: 

4 
5 

EN 

http://www.who.int/ihr/en/ 
More  information  on  the  Global  Health  Security  Initiative  can  be  found  in  the  Commission  Staff  Working 
Document 
at: 
http://ec.europa.eu/health/preparedness_response/docs/commission_staff_healthsecurity_en.pdf 

the  European  Union 

on  Health  Security 

Internationally, 

available 

and 

in 

35 

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Monitoring the implementation of suggested actions 

Impact Indicators 

Specific Objectives 

Result Indicators 

Source of Information 

1. Improved protection of citizens of the EU from serious 
cross-border threats to health 

More  rapid  and  effective  defeat  of  cross-border  threats  to 
the  health  of  EU  citizens  (morbidity,  mortality,  Quality 
Adjusted Life Years Saved) 

External  and  independent  evaluation  four  years  after 
implementation of the legal basis 

systems: 
2.  Public  health 
Effectiveness48, efficiency49 and coherence50 as regards the 
objectives described in this initiative 

structures  and 

security 

2.1  Coherent  and  comprehensive  overall  approach  for  all 
serious  cross-border  threats  to  health  (preparedness  and 
response planning, risk monitoring and assessment as well 
as risk management including risk communication) 

response  planning,  common 
2.2.  preparedness  and 
approach at EU level for all serious cross-border threats to 
health 

Legal proposal for Health Security Initiative adopted 

a. number of new preparedness plans established at EU and 
national level 
further developed generic preparedness principles (possible 
detailed provisions for specific threats)  

a. generic and specific preparedness 

b.  ensuring  coherence  and  interoperability  among  critical 
sectors of society 

c.  common  core  capacities  for  preparedness  /  EU  tailor-
made  criteria  for  notification  (to  address  IHR  with  a 
common approach) 

b. number of preparedness and response planning in critical 
sectors of society  

c. number of agreements on minimum core capacities and 
shared standards at EU level to address IHR 

d. adoption of the proposal to set up a joint procurement 
mechanism and its implementation: number of countries 

Regular  evaluations  as  legal  requirement  (article  in  the 
legislative  text),  first  evaluation  after  four  years  of 
implementation of the legal base 

annual  reports  of  competent  authorities  in  Member  States 
based on an agreed questionnaire 

continuous  ECDC  assessment  of  preparedness  at  national 
level for communicable diseases 

synthesis reports by the Commission every two years with 
a  qualitative  evaluation  of  the  implementation  by  the 
Member States 

48 
49 
50 

Effectiveness = the extent to which options achieve the objectives of the proposal 
Efficiency/cost effectiveness = the extent to which objectives can be achieved for a given level of resources/at least cost (cost-effectiveness) 
Coherence  =  the  extent  to  which  options  are  coherent  with  the  overarching  objectives  of  EU  policy,  and  the  extent  to  which  they  are  likely  to  limit  trade-offs  across  the 
economic, social and environmental domain 

EN 

36 

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d. equitable access to medical countermeasures 

• 
comprehensive approach for  

2.3. risk monitoring and assessment: coherent and 

- identification and notification of health threats, 

• 
based on improved linkage between existing monitoring 
and notification mechanisms and structures 

- improved capacities for robust, reliable, and rapid public 
health risk assessment for serious cross-border threats to 
health  

participating, amount of medical counter-measures 
purchased through this mechanism 

standard operation procedures in place and memoranda of 
understanding agreed with relevant sectors to closer link 
existing notification structures  

EU tailor-made criteria implemented for notification of 
health threats agreed at EU level 

number and types of threats detected and reported links to 
IHR established 

strengthened capacities in place for assessment of health 
threats, regardless of their cause (number of networks in 
place and number of types of threats covered) 

number of risk assessments, type of threats assessed, 
structures that assessed the risk and quality of risk 
assessments requested and performed 

Report from the Commission 

• 

2.4. risk management: improved coordination –  

• 
cross-border public health crisis;  

- sustainable structure at EU level for any serious 

• 
commitment of Member States 

- clear mandate for this structure with strong 

Sustainable mechanism (operational EU health group) and 
structure in place for EU wide crisis management  

Report from the Commission 

Standard Operation procedures for crisis management 
agreed with Member States 

internal rules of procedures established for a unique 
structure (level of participation of Member States, number 
and quality of recommendations issued) 

2.5.crisis communication: improved conditions for crisis 
communication 

Agreement on reinforced operating procedures for risk and 
crisis communication (who, why, when, where, how, what) 

Communication  strategies  and  coordination  of  messages 
put in practice 

Number  of  campaigns  implemented,  number  of  exercises 
carried  out,  number  of  common  press  statements,  number 
and  quality  of  communication  tools,  brochures,  guidance 
documents, posters etc; 

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37 

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A more detailed inventory of existing capacities, measures and plans in terms of preparedness, 
risk  assessment  and  risk  management  at  the  level  of  each  Member  State  and  for  all  threats 
other than communicable diseases is currently being drawn up. It will allow indicators to be 
further defined and serve as the benchmark against which progress will to be measured after 
approval of the legal initiative. 

5.4. 

Grounds for the proposal/initiative  

5.4.1.  Requirement(s) to be met in the short or long term  

The aim of the Health Security Initiative (HSI) is to streamline and strengthen capacities and 
structures on health security in order to improve the protection of the citizens of the European 
Union (EU) from all serious cross-border threats that may affect public health. These threats 
can  be  events  caused  by  communicable  diseases,  biological  agents  causing  diseases  that  are 
not communicable51, and threats of chemical, environmental or unknown origin, or caused by 
climate  change.  Threats  emerging  from  the  effects  of  climate  change  (i.e.  heat  waves,  cold 
spells) are covered by environmental threats throughout the initiative. 

Due to the cross-border nature of these threats and to their potential severe consequences on 
the  EU  population,  a  coordinated  public  health  approach  at  the  EU  level  is  necessary.  The 
health security initiative aims to establish such a common EU framework on health security. 

The health security initiative intends to offer European citizens the same level of protection as 
already exists for communicable diseases and to complement and add value to actions between 
Member States through coherent and more efficient governance of health threats. It will seek 
to  reinforce  the  coordination  of  the  EU  risk  management  and  will  strengthen  the  existing 
structures and mechanisms in the public health area. 

The  legal  basis  for  the  initiative  is  provided  by  the  Lisbon  Treaty  which  introduced  a  new 
competence for the EU to set up measures in the area of serious cross-border health threats.52 
This  impact  assessment  will  examine  a  range  of  policy  options  to  improve  the  crisis 
management  cycle  from  the  public  health  perspective.  Its  scope  covers  the  following  key 
areas: 

-  the  coordination  at  EU  level  of  the  preparedness  and  response  planning  for  serious  cross-
border  threats  to  health,  including  equitable  access  to  medical  countermeasures  such  as 
vaccines and improved preparedness for all critical sectors in society. 

- the monitoring and scientific assessment at EU level of risks from these potential threats as 
independent  expertise  with  sound  scientific  advice  on  emerging  health  threats  is  required  to 
respond appropriately to a health emergency; 

51 

52 

Biological  events  can  be  caused  by  communicable  diseases  and  by  harmful  substances  produced  by  micro-
organisms (such as ricin). These harmful substances are typically found in nature, but can be produced, modified or 
manipulated to cause illness intentionally in a criminal or terrorist attack.  
See annex 1 for article 168 of the Lisbon Treaty 

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- the public health aspects of crisis management and the public health measures required under 
such  circumstances  to  prevent  or  limit  the  spread  of  public  health  threats  and  mitigate  the 
effects of such events.53. In this context, the impact assessment will also elaborate on the status 
of  the  Health  Security  Committee54  (HSC)  and  will  look  into  ways  to  ensure  effective 
communication. 

5.4.2.  Added value of EU involvement 

The  EU  added  value  would  be  increased  across  all  aspects  of  preparedness  and  response 
planning,  risk  assessment  and  risk  management  by  setting  up  strategic  and  technical 
cooperation on health security at EU level. This would be guaranteed by the establishment of a 
robust  legal  instrument  for  all  serious  cross-border  health  threats.  By  also  providing  a  legal 
basis  for  operating  a  joint  procurement  mechanism  for  medical  countermeasures  this  option 
could add value to strengthening preparedness and response capacity to deal with cross-border 
health threats across the EU. 

5.4.3.  Lessons learned from similar experiences in the past 

Recent cross-border events such as the H1N1 pandemic in 2009/2010, the volcanic ash cloud 
in 2010,  or the outbreak  of the  E.  coli/STEC O104  in 2011 have had significant impacts on 
society and demonstrated that none of these emergencies can be confined to a specific sector. 
It is not only public health that is concerned but also civil protection, food safety, international 
trade, travel and/or law enforcement, depending on the nature of the threat. 

Pandemic influenza H1N1 in 2009 and 2010 caused 2900 deaths within the EU and 18,000 
worldwide; the pandemic put heavy pressure on the health services, including intensive care, 
required contact tracing, huge investments in vaccines and antivirals and had Member States 
competing  for  better  conditions  for  procurement  of  vaccines.  The  economic  and  societal 
disruptions, particular in Mexico and the United States, where schools were e.g. closed, lead to 
disruption for tourism and travel. 

The management of Pandemic Influenza H1N1 was thoroughly evaluated55. 

Lessons  learnt  at  EU  level  and  key  messages  endorsed  by  the  Health  Security  Committee 
include  the  following56:Member  States,  the  Commission  and  EU  Agencies  continue  to 

53 

54 

55 

56 

Measures include medical countermeasures (masks, medicines) and containment of the event and decontamination 
(reduction or removal of chemical agents from persons or places which have been contaminated) A health measure 
will  not  address  issues  that  are  wider  than  public  health  and  hence  will  not  include  law  enforcement  or  civil 
protection measures. 
To avoid confusing this committee with a committee as established under Article 3 of Regulation (EU) No 
182/2011 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:055:0013:0018:EN:PDF) it would 
be appropriate to change its name and avoid the term 'committee'. Another name, such as 'EU High level Group for 
Health Security' may better reflect the true nature of this body. 
http://ecdc.europa.eu/en/healthtopics/pandemic_preparedness/pandemic_2009_evaluations 
/Pages/pandemic_2009_evaluations.aspx provides an overview of all evaluations on H1N1 
Assessment Report on the EU-wide Response to Pandemic (H1N1) 2009 covering the period 24 April2009 – 31 
August 2009: http://ec.europa.eu/health/communicable_diseases/docs/assessment_response_en.pdf; 

EN 

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evaluate  pandemic  preparedness  for  sectors  and  services  identified  as  potentially  at  risk, 
(health  and  cross-sectoral),  particularly  as  not  all  sectors  experienced  similar  levels  of 
pressure. Member States, the Commission and EU Agencies refine and publicise estimates of 
pandemic  planning  assumptions  for  a  new  pandemic  as  early  as  possible  to  enable  other 
sectors  to  prepare,  and  ensure  that  these  are  reviewed  as  the  pandemic  progresses.  Member 
States  incorporate  planning  for  the  provision  of  mutual  aid  as  part  of  generic  business 
continuity planning for health services, including health sector supply and support services. 

Many  improvements  are  needed,  for  example  the  experience  drawn  from  Pandemic  H1N1 
2009, and endorsed in the recent ECDC-WHO-Euro led workshops (Sept 2011) shows that it 
is necessary to  undertake a risk-based approach  so as  to make  responses more proportionate 
and tailored to the specific features of a particular pandemic, which may differ considerably. 

Under the current EU communicable disease legislation EU surveillance and a case definition 
for  H1N1  were  agreed  rapidly  on  the  basis  of  ECDC  and  WHO  advice.  However,  the 
statements  by  the  Health  Security  Committee  on  vaccination  coverage57,  on  travel  advice58 
and on school closures59 during the pandemic were hard to reach, slow to be agreed, and not 
always followed up by the Member States, given the informal nature of that committee. It was 
also not possible, owing to regulatory and contractual limitations, to rapidly come up with a 
mechanism for ensuring a supply of antivirals and vaccines60. 

During  the  H1N1  pandemic  in  2009,  some  Member  States  were  unable  to  procure  enough 
pandemic influenza vaccines and the vaccines when they arrived did so at very different dates 
across  the  EU  countries.  Non-equitable  access  to  pandemic  influenza  vaccines  during  the 
H1N1  (2009)  pandemic  was  due  to  weak  purchasing  power  of  Member  States  61.  This 
contrasted with what happened in parts of Latin America and the Caribbean where countries 
participating  in  the  Pan  American  Health  Organisation  routine  joint  vaccine  procurement 
mechanism received pandemic vaccines at approximately the same time, according to a pre-
agreed plan and with more advantageous conditions than EU Member States negotiated. 

Member States wishing to secure pandemic influenza vaccines were pitched against each other 
and had to accept disadvantageous contractual conditions. Evidence that was gathered for the 
Commission  in  an  independent  evaluation62  shows  the  considerable  variations  in  contractual 
conditions,  particularly  regarding  liability  for  side  effects  being  transferred  from  the 
manufacturers to the Member States. In addition, the lack of flexibility in contracts to include 
conditions  under  which  the  reserved  amount  of  doses  could  be  changed  or  excess  vaccines 
could be returned resulted in an enormous waste of resources. The Member States that could 

57 

58 

59 

60 
61 

62 

HSC/EWRS statement on Influenza A(H1N1) 2009: target and priority groups for vaccination, 25 August 2009 
http://ec.europa.eu/health/archive/ph_threats/com/influenza/docs/hsc_ewrs_statement_en.pdf 
HSC/EWRS statement on Influenza A(H1N1) 2009 Symptomatic individuals travelling, 13 August 2009 
http://ec.europa.eu/health/archive/ph_threats/com/influenza/docs/statement_travel_en.pdf 
HSC/EWRS statement on School closures, 13 August 2009: 
http://ec.europa.eu/health/archive/ph_threats/com/influenza/docs/statement_school_en.pdf 
http://ec.europa.eu/health/preparedness_response/docs/council_lessonsh1n1_en.pdf 
Assessment 
http://ec.europa.eu/health/communicable_diseases/docs/assessment_vaccine_en.pdf 
http://ec.europa.eu/health/communicable_diseases/docs/assessment_vaccine_en.pdf  

pandemic 

strategies 

vaccine 

report 

wide 

EU 

on 

of 

25.8.2010 

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not  accept  those  unfavourable  conditions  had  no  guarantee  at  all  of  being  able  to  obtain 
pandemic  influenza  vaccines,  thus  weakening  the  preparedness  across  the  EU  against  such 
cross-border  health  threat.  This  could  have  had  very  serious  health  consequences  if  the 
pandemic had proved more virulent and deadly. 

There were difficulties in communicating with health professionals and the public on the need 
for pandemic vaccination in the 2009 H1N1 pandemic.63 

Due to the huge interruption of transport during the Volcanic ash cloud from Iceland in 2010 
e.g. organ transplants had to be postponed due to delays in the delivery of organs, there were 
also  problems  of  medicines  for  people  stranded  abroad  without  their  usual  medicines  and 
without  any  prescription  and  of  course,  respiratory  problems  especially  for  people  with 
medical conditions. 

The recent E.coli/STEC O104 outbreak made 3910 people ill and caused 46 deaths within 2 
months  only.  It  led  to  overflowing  intensive  care  units  in  Germany,  shortages  of  medical 
equipment  e.g.  for  dialysis,  extreme  pressure  on  laboratory  capacity  needed  to  examine  the 
samples and to lack of public confidence in health measures. This epidemic had a huge impact 
on the vegetable/agriculture sector in the EU. A EUR 227 million compensation scheme was 
established  by  the  import  ban  of  Russia  during  2  months  for  EU  fresh  vegetables  lead  to 
additional extrapolated costs of EUR 100 million. 

The  experience  with  E.coli/STEC  O104  clearly demonstrated  how  insufficient  preparedness, 
inadequate  response  or  communication  strategies  in  one  Member  State  have  led  to  more 
severe negative impacts on others. 

Premature communication to the general public and to the press on the source of the outbreak 
was  made  at  various  levels.  Certain  national/regional  announcements  were  not  backed  by 
sound  scientific  evidence  or  risk  assessment.  This  leads  to  difficulties  in  the  efficient 
management of the crises and important economic impacts. 

Citizens  and  external  States  stopped  eating/importing  fresh  vegetables.  This  had  devastating 
consequences  for  the  producers  of  the  vegetables  in  question  (salad,  cucumbers,  sprouts),  in 
particular in the South of Europe. 

The estimation of the economic operators' losses in the first two weeks of the crisis is at least 
of  EUR  812.6  million,  according  to  farmers'  organizations.  These  data  may  represent  an 
underestimation,  since  it  does  not  cover  the  whole  period  of  the  crisis  and  does  not  include 
figures  from  all  EU  countries.  Losses  caused  by  several  trade  restrictions  adopted  by  third 
states (ban of imports) have also to be taken in account (e.g. Russia banned vegetables import 
with losses estimated in EUR 600 million). 

The Commission played an active role in order to reduce the financial burden incurred by this 
crisis. A EUR 210 million aid package was immediately adopted and further EUR 75.1 million 

63 

http://ec.europa.eu/health/communicable_diseases/docs/assessment_response_en.pdf (chapter 12) 

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of shared aids with MS are aimed to the promotion of agricultural products in the next three 
years. 

Communication with the public on risks arising from E. coli STEC O104 in 2011 was difficult 
due to inconsistent and uncoordinated messages at regional, national and EU level, as well as 
those originating from the WHO. 

Following several terrorist attacks involving chlorine in Iraq in March 2007, Europol urgently 
requested to the Commission to assess the potential of chlorine to become a common terrorist 
weapon and, more particularly, the possibility of this substance being used in Europe. There is 
no EU body which could deal with such a risk assessment and therefore the Commission had 
to  collect  information  from  different  sources,  such  as  the  Chemical  Working  Group  of  the 
HSC, from the representatives of funded projects on the subject from the Health Programme 
and by means of joint efforts with ECHA and JRC. The absence of a mechanism to mobilise 
appropriate  expertise  led  to  delay  in  making  a  risk  assessment,  despite  the  existence  of 
assessments aimed at law enforcement or civil protection. 

There was also a problem concerning public risk assessment in relation to the melamine milk 
contamination event in 2008.64 Based on their knowledge, the food safety authorities did not 
see  a  risk  for  adults  in  Europe.  However,  public  health  authorities  had  to  address  citizen's 
concerns  about  longer  term  effects,  particularly  for  travellers  returning  from  China  who  had 
been  at  risk  of  having  consumed  contaminated  milk  and  composite  products.  There  was  no 
possibility  to  have  a  comprehensive  and  rapid  public  health  risk  assessment  and  also  no 
possibility to enable surveillance of exposed persons in the short, medium or long term. 

Concerning chemical events, a series of table top exercises have been run in 2011 ("Iridium") 
to simulate incidents caused by dangerous chemicals, based on real life events. For example, a 
leaking container on a ferry on the Baltic Sea caused illness in passengers and ship workers 
that  came  in  contact  with  the  chemical,  but  they  had  to  travel  on  to  their  destinations.  They 
presented unusual and non-specific symptoms65. 

It  became  apparent  during  the  exercises  that  there  is  a  gap  in  the  mechanisms  currently  in 
place at EU level to trigger and alert or to provide notification of the impact that an unfolding 
chemical  incident  could  have  or  has  on  public  health,  in  order  to  make  an  early  risk 
assessment  or  to  develop  an  EU  case  definition  to  control  and  contain  the  impact  on  public 
health  of  a  chemical  incident.  Standard  operating  procedures  for  public  health  impact  of  a 
chemical event at EU level, and possibly proposal of new provisions would provide a stronger 
basis for addressing the public health aspects of chemical incidents. 

64 

65 

Melamine  accumulates  in  the  body  and  causes  toxicity  problems.  Products  across  the  globe  containing 
contaminated  milk  have  been  imported  from  China  in  2008.  According  to  WHO,  more  than  51  900  infants  and 
young children in China were hospitalized for urinary problems, possible renal tube blockages and possible kidney 
stones related to the consumption of melamine contaminated infant formula and related dairy products. Six deaths 
among infants have been confirmed in mainland China. 
http://ec.europa.eu/health/preparedness_response/docs/iridium_1_2011_frep_en.pdf 

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There  were  difficulties  in  managing  cross-border  chemical  events,  as  shown  in  the  Iridium 
exercise report. (Sectors concerned were chemicals, transport, health, and maritime transport). 

There was an absence of management measures at EU level to tackle the heat waves in 2003 
when  people  died  due  to  the  heat;  no  discussion  of  coordinated  measures,  for  example  on 
sharing of hospital capacities across national borders. 

The absence of adequate coordination of measures at EU level and of the follow up to the spill 
of  aluminium  sludge  in  Hungary,  affecting  the  Danube  River  in  2010  (Environment, 
chemicals, health and civil protection was another example). 

5.4.4.  Coherence and possible synergy with other relevant instruments 

In a more general strategic framework,  the health security initiative will  help implement the 
European  Health  Strategy66  and  also  contribute  to  the  objectives  of  Europe  202067  by 
promoting health as an integral part of the smart and inclusive growth objectives. Furthermore, 
it  will  contribute  to  the  overall  European  Security  context  and  will  build  on  existing 
instruments and strategies related to disaster prevention and control. 

Several principle areas under the TFEU are dealing with EU disaster prevention and control. 
Mechanisms  related  with  EU  disaster  prevention  and  control  cover  civil  protection  (Article 
196),  solidarity  clause  (Article  222),  EU  financial  assistance  (Article  122),  humanitarian  aid 
(Article 214), cohesion policy and home affairs. In addition, TFEU lays down provisions on 
EU's external action in relation with international cooperation on assistance in case of natural 
or man-made disasters (Article 21). Furthermore, EU secondary legislation establishes specific 
rules in the field of EU disaster prevention and control (e.g. Seveso II). 

The  EU  has  a  series  of  policies,  mechanisms  and  instruments  to  cater  for  prevention  and 
control of serious cross border threats to health and develop capacities to manage crises68. A 
non-exhaustive list includes the civil protection mechanism, the Internal Security Strategy, the 
Cohesion and Solidarity Funds, pan-European alert networks such as ECURIE, to name only a 
few69. 

All these are managed by the responsible Commission services. Furthermore, over twenty EU 
Agencies  provide  information  and  advice,  oversee  operations  and  support  policymaking. 
Crisis management coordination at corporate level is done through ARGUS, the Commission's 
crisis  management  corporate  system.  The  Commission  ensures  broader  internal  coordination 
by  means  of  an  inter-service  group  on  Community  Capacity  in  Crisis  Management  which 
brings together all relevant Directorates-General and services as well as EU Agencies. In this 
group DG SANCO has informed on the health security initiative and has also received input 
for the impact assessment.  

66 

67 
68 
69 

Health  Strategy:  COM(2007)  630  final  -  White  paper  -  Together  for  Health:  A  Strategic  Approach  for  the  EU 
2008-201; http://ec.europa.eu/health-eu/doc/whitepaper_en.pdf 
EU 2020- EU Strategy for smart, sustainable and inclusive growth; http://ec.europa.eu/europe2020/index_en.htm 
See detailed information in annex 7 
For further details, please see the "Inventory of Crisis Management Capacities in Commission and Agencies" 

EN 

43 

   EN 

 
                                                 
The health security initiative is part of the overall EU mechanisms and strategies for disaster 
prevention and control. It will lead to intensified inter-action with all relevant sector specific 
disaster management structures which are in operation at EU level. 

In the area of health security, there are already a number of EU structures in place, namely: 

-  EU  Agencies,  such  as  the  European  Food  Safety  Authority  (EFSA),  European  Medicines 
Agency (EMA), European Maritime Safety Agency (EMSA), European Monitoring Centre for 
Drugs  and  Drug  Addiction  (EMCDDA),  European  Agency  for  Safety  and  Health  at  Work 
(EU-OSHA) and the European Chemicals Agency (ECHA); 

for  Feed  and  Food 

- designated networks such as the Animal Disease Notification System (ADNS), Rapid Alert 
in 
System 
Pharmaceuticals  (EUDRANET),  Rapid  Alert  System  for  Non-Food  Dangerous  Products 
(RAPEX), Monitoring and Information Centre (MIC), and RAS-CHEM, which is a rapid alert 
system for chemical health risks; 

(RASFF),  European  Telecommunication  Network 

-  scientific  committees  (on  consumer  products,  health  and  environment  risks  and  newly 
identified health risks) are in charge of risk assessment, depending on the type of threat70; 

To avoid overlaps with the existing structures, a gap analysis based on the mechanisms and 
structures  in  place  within  the  Commission  and  various  EU  Agencies,  such  as  the  European 
Centre  for  Disease  Prevention  and  Control,  the  European  Medicines  Agency,  the  European 
Food Safety Authority and Frontex was done to support this impact assessment. The review 
revealed  that  these  structures  do  not  address  cross  border  health  threats  preparedness  and 
response  in  a  sufficient  manner.  Especially,  they  do  not  provide  a  coherent  and  satisfactory 
basis for decisions on public health measures that might be necessary to manage risks and to 
ensure effective follow-up of events. Also, many of the structures are operated without being 
sufficiently  inter-linked  with  authorities  and  agencies  responsible  for  public  health  in  the 
Member States and/or at EU level. 

The  Health  Security  Initiative  will  contribute  to  other  EU  initiatives  in  the  area  of  law 
enforcement and civil protection: 

The initiative will help put in place the EU Internal Security Strategy71, which makes specific 
reference to the health security initiative. 

The initiative will be instrumental to strengthen chemical and biological security in the EU as 
set  out  in  the  CBRN  action  plan72.  The  close  cooperation  that  is  ongoing  between  Member 
States' authorities and agencies and DG HOME and SANCO, backed up by Europol and the 
European  Centre  for  Disease  Prevention  and  Control,  and  which  is  undertaken  in  the 

70 
71 
72

EN 

http://ec.europa.eu/health/scientific_committees/policy/index_en.htm 
http://ec.europa.eu/commission_2010-2014/malmstrom/archive/internal_security_strategy_in_action_en.pdf 

http://www.europarl.europa.eu/meetdocs/2009_2014/documents/com/com_com(2009)0273_/com_com(2

009)0273_en.pdf;  

44 

   EN 

 
                                                 
 
framework  of  the  “bridging  security  and  health”  arrangement  will  be  reinforced  through 
improved cross border health threats preparedness and response as a result of the initiative. 

In the area of civil protection, the Commission adopted on 5 March 2008 a Communication on 
reinforcing  the  Union's  disaster  response  capacity.73  It  was  followed  after  by  a  Commission 
Communication of 26 October 2010 on "Towards a stronger European disaster response: the 
role  of  civil  protection  and  humanitarian  assistance"74.  EU  co-operation  in  the  field  of  civil 
protection  aims  to  better  protect  people,  their  environment,  property  and  cultural  heritage  in 
the event of major natural or manmade disasters occurring both inside and outside the EU. 

Close  cooperation  between  DG  ECHO,  DG  SANCO,  backed  up  by  ECDC,  in  preparedness 
and  response  to  civil  disasters  is  ongoing  and  has  proven  to  be  effective  in  several  crisis 
situations. 

In  2010  under  the  “Instrument  for  Stability”  the  EU  started  a  project  that  will  allow  third 
countries  to  collaborate  in  numerous  regions  of  the  world  to  build  capacities  for  mitigating 
risks from chemical, biological, radiological and nuclear materials, irrespective of the origin of 
the risk (natural, criminal, industrial accident). Possible synergies will be explored under the 
Health  Security  Initiative  with  the  activities  of  these  regional  CBRN  (Chemical,  Biological, 
Radio-Nuclear) Centres of Excellence. 

73 
74 

COM(2008) 130 final: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0130:FIN:EN:PDF 
COM(2010) 600 final: 
http://ec.europa.eu/echo/civil_protection/civil/prote/pdfdocs/COM_2010_600_European_disaster_response_en.pdf 

EN 

45 

   EN 

 
                                                 
5.5. 

Duration and financial impact  

(cid:133) Proposal/initiative of limited duration  

–  (cid:133)  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–  (cid:133)  Financial impact from YYYY to YYYY  

(cid:59) Proposal/initiative of unlimited duration 

–  Full-scale operation on the day following that of its publication in the Official Journal of 

the European Union. 

5.6.  Management mode(s) envisaged75  

(cid:59) Centralised direct management by the Commission  

(cid:59) Centralised indirect management with the delegation of implementation tasks to: 

–  (cid:133)  executive agencies  

–  (cid:59)  bodies set up by the Communities76  

–  (cid:133)  national public-sector bodies/bodies with public-service mission  

–  (cid:133)  persons entrusted with the implementation of specific actions pursuant to Title V of the 
Treaty  on  European  Union  and  identified  in  the  relevant  basic  act  within  the  meaning  of 
Article 49 of the Financial Regulation  

(cid:133) Shared management with the Member States  

(cid:133) Decentralised management with third countries  

(cid:133) Joint management with international organisations (to be specified) 

If more than one management mode is indicated, please provide details in the "Comments" section. 

Comments  

Where  the  (potential)  serious  cross-border  threats  to  health  is  related  to  a  communicable  disease  or 
from  unknown  origin,  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC)  will  be 
involved in the areas of preparedness and response planning, and risk monitoring and assessment. 

75 

76 

Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the  BudgWeb  site: 
http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 
As referred to in Article 185 of the Financial Regulation. 

EN 

46 

   EN 

 
                                                 
6. 

MANAGEMENT MEASURES  

6.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

The expenditure will be monitored on an annual basis in order to both assess headway towards 
the achievement of its specific objectives against its outcome and impact indicators and allow 
for any necessary adjustments of the policy and funding priorities.  

Given that expenditure will mainly be covered by the Health Programme, the expenditure will 
be  subject  to  the  mid-term  term  and  ex-post  evaluation  of  the  Programme.  A  mid-term 
evaluation  will  aim  at  measuring  progress  made  in  meeting  the  Programme  objectives, 
determining whether its resources have been used efficiently and assessing its European added 
value.  

The ex-post evaluation of the current Programme (2008 – 2013), which is foreseen before the 
end of 2015, will also provide useful elements for the implementation of the Programme 2014 
– 2020. 

Expenditure  not  covered  by  the  Programme,  ie  the  expenses  financed  by  Medical  services, 
from  BL  2601,  will  be  subject  to  an  evaluation  every  5  years,  where  the  Commission  shall 
examine  the  need  to  amend  this  Regulation  and  shall  present  a  report  to  the  European 
Parliament  and  the  Council  on  its  application  accompanied,  if  appropriate,  by  a  legislative 
proposal. In this respect,  

6.2.  Management and control system  

6.2.1.  Risk(s) identified  

The main risks are the following: 

*  Risk  of  inefficient  or  non-economic  use  of  funds  awarded  for  procurement  (sometimes 
limited  number  of  economic  providers  with  the  required  specialist  knowledge  entailing 
insufficient possibilities to compare price offers); 

*  Reputational  risk  for  the  Commission,  if  fraud  or  criminal  activities  are  discovered;  only 
partial assurance can be drawn from the third parties' internal control systems due to the rather 
large number of heterogeneous contractors and beneficiaries, each operating their own control 
system, often rather small in size. 

6.2.2.  Control method(s) envisaged  

The  budget  will  be  implemented  by  centralised  direct  management,  though  parts  of  the 
implementation  tasks  might  be  delegated  to  the  ECDC.  This  agency  set  up  its  own  internal 
control system, is supervised by DG SANCO, and audited by the Court of Auditors. 

EN 

47 

   EN 

 
DG  SANCO  and  the  ECDC  alike  put  in  place  internal  procedures  that  aim  at  covering  the 
risks  identified  above.  The  internal  procedures  are  in  full  compliance  with  the  financial 
regulation and include cost-benefit considerations. Within this framework, SANCO continues 
to  explore  possibilities  to  enhance  the  management  and  to  increase  simplification.  Main 
features of the control framework are the following: 

Characteristics of the selection process of offers: each call for proposal/tender is based on 
the annual Work Programme adopted by the Commission. In each call, the exclusion, selection 
and  award  criteria  for  selecting  proposals/offers  are  published.  Against  these  criteria,  an 
evaluation  committee,  possibly  assisted  by  external  experts,  evaluates  each  proposal/offer 
observing  the  principles  of  independence,  transparency,  proportionality,  equal  treatment  and 
non-discrimination. 

External  Communication  strategy:  DG  SANCO  has  a  well  developed  communication 
strategy that seeks to ensure the contractors'/beneficiaries' full understanding of the contractual 
requirements and provisions. Following means are being used: EUROPA website, "frequently 
asked questions", a help desk, extensive guidance notes as well as information meetings with 
beneficiaries/contractors. 

* Controls before and during the implementation of contracts: 

-  DG  SANCO  uses  the  model  service  contracts  recommended  by  the  Commission.  They 
provide for a number of control provisions such as audit certificates, financial guarantees, on-
site audits as well as inspections by OLAF. 

-  All  staff  signs  the  code  of  good  administrative  behaviour.  Staff  who  are  involved  in  the 
selection procedure or in the management of the contracts also sign a declaration of absence of 
a conflict of interest. Staff is regularly trained and uses networks to exchange best practices. 

- Technical implementation of a contract is checked at regular intervals at the desk on the basis 
of technical progress reports of  the contractor;  in addition contractors'  meetings and on-site-
visits are foreseen on a case by case basis. 

- DG SANCO's financial procedures are supported by the Commission's IT tools and have a 
high degree of segregation of duties: all financial transactions related to contracts are verified 
by two independent persons before they are signed by the authorising officers responsible for 
the activity. Operational initiation and verification is carried out by different members of staff 
of  the  policy  areas.  Payments  are  made  on  the  basis  of  a  number  of  pre-defined  supporting 
documents such as approved technical reports as well as verified cost claims and invoices. For 
a  sample  of  transactions,  the  central  financial  cell  performs  second-level  ex-ante  desk 
verification; on a case by case basis, also an ex-ante on-site financial control can be carried out 
prior to final payment. 

* Controls at the end of the contract:  

DG  SANCO  has  a  centralised  audit  team  which  verifies  on-the-spot  the  eligibility  of  cost 
claims. The aim of these controls is to prevent, detect and correct material errors related to the 
legality  and  regularity  of  financial  transactions.  With  a  view  to  achieving  a  high  control 

EN 

48 

   EN 

 
impact, the selection of contractors to be audited foresees to (a) combine a risk based selection 
with a random sampling, and (b) pay attention to operational aspects whenever possible during 
the on-site audit. 

* Costs and benefits of controls:  

The  Programme's  management  and  control  measures  are  designed  on  the  basis  of  past 
experience: in the past three years, the established internal control system ensured an average 
residual error rate of less than 2% as well as compliance with the procurement procedures laid 
down  in  the  financial  regulation.  These  are  the  two  main  "control  objectives"  of  both  the 
previous and the new Health Programme. 

As  the  main  design  features  of  the  new  Programme  are  not  significantly  different  from  the 
previous Programme, the risks related to Programme implementation are considered to remain 
relatively  stable.  Thus,  the  established  management  and  control  measures  are  planned  to  be 
continued;  nevertheless,  further  simplifications  that  might  become  possible  under  the  new 
financial regulation will be taken up as soon and as far as possible. 

Thanks to risk based ex-ante and ex-post controls as well as desk checks and on-site audits, 
the "control objectives" will be achieved at a reasonable cost level. The benefits of achieving 
an  average  residual  error  rate  of  less  than  2%  and  compliance  with  the  provisions  of  the 
financial  regulation  are  assessed  as  sufficiently  important  to  justify  the  chosen  management 
and control measures. 

6.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

In addition to the application of all regulatory control mechanisms, DG SANCO will devise an 
anti-fraud strategy in line with the Commission's new anti-fraud strategy (CAFS) adopted on 
24 June 2011 in order to ensure inter alia that its internal anti-fraud related controls are fully 
aligned with the CAFS and that its fraud risk management approach is geared to identify fraud 
risk areas and adequate responses. Where necessary, networking groups and adequate IT tools 
dedicated to analysing fraud cases will be set up in particular a series of measures such as: 

-  decisions,  agreements  and  contracts  resulting  from  the  implementation  of  the  Health 
Programme will expressly entitle the Commission, including OLAF, and the Court of Auditors 
to conduct audits, on-the-spot checks and inspections; 

-  during  the  evaluation  phase  of  a  call  for  proposals/tender,  the  proposers  and  tenderers  are 
checked against the published exclusion criteria based on declarations and the Early Warning 
System (EWS); 

-  the  rules  governing  the  eligibility  of  costs  will  be  simplified  in  accordance  with  the 
provisions of the Financial Regulation; 

EN 

49 

   EN 

 
- regular training on issues related to fraud and irregularities is given to all staff involved in 
contract  management  as  well  as  to  auditors  and  controllers  who  verify  the  beneficiaries' 
declarations on the spot. 

EN 

50 

   EN 

 
7. 

7.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

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

•  Existing expenditure budget lines  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of  
expenditure

Contribution  

Number  
[Description………………………...……….
] 

Diff./non-
diff. 
(77) 

from 
EFTA78 
countries 

from 
candidate 
countries79 

from third 
countries 

within the meaning 
of Article 18(1)(aa) 
of the Financial 
Regulation  

17 03 06 

Union action in the field of health 

17 01 04 

Diff. 

YES 

YES 

NO 

NO 

Heading of 
multiannual 
financial 
framework 

3. Security 
and 
citizenship 

3. Security 
and 
citizenship 

in 

Programme  of  the  European  Union 
the  field  of  health  – 
action 
administrative 
Expenditure 
management 

on 

17 01 02 11 

5. 
Administrati
on 

External 
staff  and  other  management 
expenditure  in  support  of  the  ‘Health  and 
consumer  protection’  policy  area  –  Other 
management expenditure 

26 01 50 01 

5. 
Administrati
on 

Administrative  expenditure  of  the 
'Commission's  administration'  policy 
area 
and 
policy 
–  Personnel 
management – Medical service 

•  New budget lines requested  

non-diff.

YES 

YES 

NO 

NO 

non-diff.

YES 

YES 

NO 

NO 

non-diff.

NO 

NO 

NO 

NO 

In order of multiannual financial framework headings and budget lines. 

Heading of 

Budget line 

Type of 

Contribution  

77 
78 
79 

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

EN 

51 

   EN 

 
                                                 
multiannual 
financial 
framework 

Number  
[Heading…………………………………
…..] 

Diff./non-
diff. 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the meaning 
of Article 18(1)(aa) 
of the Financial 
Regulation  

expenditure

EN 

52 

   EN 

 
 
 
 
 
 
 
 
7.2. 

Estimated impact on expenditure  

7.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial 
framework:  

Number 
3 

Security and citizenship 

EUR million (to 3 decimal places) in current prices  

DG: SANCO 

(cid:121) Operational appropriations  

17 03 06 

Budget line 

Appropriations 
administrative 
 from the envelope for specific programmes82  

an 

of 

Year 
201380 

Year 
2014 

Year 
2015 

Subsequent years 

TOTAL81 

2.081 

2.123 

2.165 

0.694 

1.415 

2.165 

=(commitment 
year-1)*1.02 

Commitments 

Payments 

Commitments 

Payments 

(1) 

(2) 

(1a) 

(2a) 

nature 

financed 

17 01 04 

(3) 

0.084 

0.086 

0.088 

=(commitment 
year-1)*1.02 

TOTAL appropriations 
for DG SANCO 

Commitments 

Payments 

=1+1a 
+3 

=2+2a 

+3 

2.165 

2.209 

2.253 

0.778 

1.501 

2.253 

80 
81 

82 

EN 

Year N is the year in which implementation of the proposal/initiative starts. Depends on year of adoption of the Decision (co-decision procedure). 
For the first three years. Every three years, a technical report on the activities of the Early Warning and Response System and other activities carried out in the 
context of the implementation of this Decision from the previous years will be forwarded to the European Parliament and the Council. 
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former "BA" lines), indirect 
research, direct research. 

53 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(4) 

(5) 

(6) 

2.081 

2.123 

2.165 

0.694 

1.415 

2.165 

0.084 

0.086 

0.088 

=(commitment 
year-1)*1.02 

=(commitment 
year-1)*1.02 

TOTAL appropriations  
under HEADING 3 Security and 
citizenship 
of the multiannual financial framework 

Commitments 

=4+ 6 

2.165 

2.209 

2.253 

Payments 

=5+ 6 

0.778 

1.501 

2.253 

If more than one heading is affected by the proposal / initiative: 

(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(4) 

(5) 

(6) 

TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial framework 
(Reference amount) 

Commitments 

=4+ 6 

Payments 

=5+ 6 

Heading of multiannual financial 
framework:  

5 

" Administrative expenditure " 

Year20
13 

Year 
2014 

Year 
2015 

Subsequent years  

TOTAL 

EUR million (to 3 decimal places) in current prices 

DG: SANCO 

EN 

54 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:121) Human resources (17 01 01 01) 
(cid:121) Other administrative expenditure (17 01 02 11) 

0;540

0.096

0.540

0.096

0.540 

0.096 

0.540

0.096

TOTAL DG SANCO 

Appropriations  

Year 
2013 

Year 
2014 

Year 
2015 

… enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  

TOTAL 

DG: HR 

(cid:121) Human resources 83 
(cid:121) Other administrative expenditure (26 01 50 01) 

TOTAL DG HR 

Appropriations  

0.030 

0.030 

TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework  

(Total 
= Total payments) 

commitments 

Year 
N84 

Year 
N+1 

Year 
N+2 

… enter as many years as 
necessary to show the duration 
of the impact (see point 1.6) 

TOTAL 

EUR million (to 3 decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework  

Commitments 

Payments 

83 
84 

Joint procurement of pandemic influenza vaccines coordinated by DG SANCO 
Year N is the year in which implementation of the proposal/initiative starts. 

EN 

55 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
7.2.2.  Estimated impact on operational appropriations  

–  (cid:133)  The proposal/initiative does not require the use of operational appropriations  

–  (cid:59)  The proposal/initiative requires the use of operational appropriations, as explained below: 

Indicate objectives and 
outputs  

Year 

2013 

Year 
2014 

Year 
2015 

TOTAL 

OUTPUTS 

(cid:216) 

Type of output85 

Average 
cost  
of the 
output 

SPECIFIC OBJECTIVE  
No 189 

Preparedness and response 
planning 

r
e
b
m
u
N

6
8
s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

7
8
s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

Total 
number 
of 
outputs
88 

Total  
cost 

 output 

 output 

 output 

New preparedness plans established at EU and national level 

Further developed generic preparedness principles (possible 
detailed provisions for specific threats)  

Preparedness  and  response  planning  in  critical  sectors  of 
society  

1 

1 

1 

0.066 

0.066 

0.066 

0 

1 

0 

0.000 

0.066 

0.000 

0 

1 

0 

0.000 

0.066 

0.000 

1 

3 

1 

0.066 

0.198 

0.066 

85 
86 
87 
88 
89 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
Only outputs at EU level are considered 
Only outputs at EU level are considered 
Only outputs at EU level are considered 
As described in Section 1.4.2. "Specific objective(s)…" 

EN 

56 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 output 

 output  

Agreements on minimum core capacities and shared standards 
at EU level to address IHR 

Proposal to set up a joint procurement mechanism and its 
implementation: countries participating, medical counter-
measures purchased through this mechanism 

1 

1 

0.066 

0.066 

5 

0.330 

1 

0 

2 

0.066 

0.000 

1 

0 

0.066 

0.000 

0.132 

2 

0.132 

3 

1 

9 

0.198 

0.066 

0.594 

Standard operation procedures in place and memoranda of 
understanding agreed with relevant sectors to closer link 
existing notification structures  

EU tailor-made criteria implemented for notification of health 
threats agreed at EU level 

Links to IHR established 

Strengthened capacities in place for assessment of health 
threats, regardless of their cause, and networks in place  

1 

0.050 

1 

0.050 

1 

0.050 

3 

0.150 

1 

1 

3 

6 

0.050 

0.050 

0.100 

0.250 

0 

0 

0 

1 

0.000 

0.000 

0.000 

0.050 

0 

0 

0 

1 

0.000 

0.000 

0.000 

0.050 

1 

1 

3 

8 

0.050 

0.050 

0.100 

0.350 

Sub-total for specific 
objective N°1 

SPECIFIC OBJECTIVE  
No 2 

Risk monitoring and 
assessment 

output 

Sub-total for specific 
objective N°2 

SPECIFIC OBJECTIVE  
No 3 

Risk management 

output 

Sustainable mechanism (operational EU health group) and 
structure in place for EU wide crisis management  

1 

0.063 

0 

0.000 

0 

0.000 

1 

0.063 

EN 

57 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
output 

output 

output 

Standard Operation procedures for crisis management agreed 
with Member States 

Internal rules of procedures established for a unique structure 
(level of participation of Member States) 

Committee in charge of implementing acts put in place 

Sub-total for specific 
objective N°3 

SPECIFIC OBJECTIVE  
No 4 

Risk and crisis 
communication 

output 

output 

Agreement on reinforced operating procedures for risk and 
crisis communication (who, why, when, where, how, what) 

Campaigns implemented; exercises carried out; common press 
statements,  communication 
tools,  brochures,  guidance 
documents, posters etc produced; 

1 

1 

1 

4 

1 

3 

0.063 

0.062 

0.062 

0.250 

0.050 

1.201 

Sub-total for specific 
objective N°4 

TOTAL COST 

4 

1.251 

0.193 

19 

2.081

0 

0 

0 

0 

0 

5 

5 

8 

0.000 

0.000 

0.000 

0.000 

0.000 

1.941 

1.941 

2.123
90 

0 

0 

0 

0 

0 

5 

5 

8 

0.000 

0.000 

0.000 

0.000 

1 

1 

1 

4 

0.063 

0.062 

0.062 

0.250 

0.000 

1 

0.050 

1.983 

13 

5.125 

1.983 

14 

5.175 

2.165
91 

35 

6.369 

90 
91 

EN 

=(commitment year-1)*1.02 
=(commitment year-1)*1.02 

58 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
7.2.3.  Estimated impact on appropriations of an administrative nature 

7.2.3.1.  Summary  

–  (cid:133)  The  proposal/initiative  does  not 

require 

the  use  of  administrative 

appropriations  

–  (cid:59)  The  proposal/initiative  requires  the  use  of  administrative  appropriations,  as 

explained below: 

EUR million (to 3 decimal places) in current prices 

Year 
2013 92 

Year 
2014 

Year 
2015 

Subsequent years 

TOTAL 

HEADING 5 
of the multiannual 
financial framework 

Human resources  

0.540 

0.540 

0.540 

Other administrative 
expenditure (17 01 
02 11) 

Administrative 
expenditure of the 
'Commission's 
administration' 
policy area – 
Personnel policy and 
management - 
Medical service (26 
01 50 01 

Subtotal HEADING 5 
of the multiannual 
financial framework  

Outside HEADING 593 
of the multiannual 
financial framework  

Human resources  

Other expenditure  
of an administrative 
nature (17 01 04) 

Subtotal  
outside HEADING 5 
of the multiannual 

0.096 

0.096 

0.096 

0.096 

0.030 

0.084 

0.086 

0.088 

=(commitment year-1)*1.02 

92 
93 

Year N is the year in which implementation of the proposal/initiative starts. 
Technical  and/or  administrative  assistance  and  expenditure  in  support  of  the  implementation  of  EU 
programmes and/or actions (former "BA" lines), indirect research, direct research. 

EN 

59 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
financial framework  

TOTAL 

EN 

60 

   EN 

 
 
 
 
 
 
7.2.3.2.   Estimated requirements of human resources  

–  (cid:133)  The proposal/initiative does not require the use of human resources  

–  (cid:59)  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 
2013 

Year 
2014 

Year 
2015 

Year 
N+3 

… enter as many years 
as necessary to show 
the duration of the 
impact (see point 1.6) 

(cid:121) Establishment plan posts (officials and temporary agents) 

17 01 01 01 (Headquarters and Commission’s 
Representation Offices) 

 4 

 4 

4 

4 

4 

4 

4 

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

(cid:121) External personnel (in Full Time Equivalent unit: FTE)94 

XX 01 02 01 (CA, INT, SNE from the "global 
envelope") 

XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations) 

XX 01 04 yy 95 

- at Headquarters96 

- in delegations  

XX 01 05 02 (CA, INT, SNE - Indirect 
research) 

10 01 05 02 (CA, INT, SNE - Direct research) 

Other budget lines (specify) 

TOTAL 

0.5 

0.5 

0.5 

0.5 

0.5 

0.5 

0.5 

4.5 

4.5 

4.5 

4.5 

4.5 

4.5 

4.5 

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

94 

95 
96 

CA= Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune Expert en Délégation" (Young 
Experts in Delegations); LA= Local Agent; SNE= Seconded National Expert;  
Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
Essentially  for  Structural  Funds,  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and 
European Fisheries Fund (EFF). 

EN 

61 

   EN 

 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Description of tasks to be carried out: 

Officials and temporary agents 

External personnel 

EN 

62 

   EN 

 
 
 
7.2.4.  Compatibility with the current multiannual financial framework  

–  (cid:59)  Proposal/initiative  is  compatible  the  current  multiannual  financial  framework 
and  with  the  2014-2020  multiannual  financial  framework  as  proposed  in 
Commission Communication COM(2011)500. 

–  (cid:133)  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. 

–  (cid:133)  Proposal/initiative requires application of the flexibility instrument or revision 

of the multiannual financial framework1. 

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

7.2.5.  Third-party contributions  

–  (cid:59)  The proposal/initiative does not provide for co-financing by third parties  

–  (cid:133)  The proposal/initiative provides for the co-financing estimated below: 

Appropriations in EUR million (to 3 decimal places) 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

… enter as many years as 
necessary to show the duration 
of the impact (see point 1.6) 

Total 

Specify  the  co-financing 
body  

TOTAL appropriations 
cofinanced  

1 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

63 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
7.3. 

Estimated impact on revenue  

–  (cid:59)  Proposal/initiative has no financial impact on revenue. 

–  (cid:133)  Proposal/initiative has the following financial impact: 

(cid:133) 

(cid:133) 

on own resources  

on miscellaneous revenue  

Appropriation
s available for 
the ongoing 
budget year 

Budget revenue line: 

Article …………. 

EUR million (to 3 decimal places) 

Impact of the proposal/initiative2 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

… insert as many columns as necessary 
in order to reflect the duration of the 
impact (see point 1.6) 

2 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 25% for collection costs. 

EN 

64 

   EN