COMMISSION STAFF WORKING PAPER IMPACT ASSESSMENT
Date: 2011-12-08
Institutions: European Commission
Subjects: cross-border cooperation, disease prevention, health control, health risk, infectious disease, therapeutics

EUROPEAN COMMISSION 

Brussels, 8.12.2011 
SEC(2011) 1519 final 

COMMISSION STAFF WORKING PAPER 

IMPACT ASSESSMENT  

Accompanying the document 

Decision of the European Parliament and of the Council 

on serious cross-border threats to health 

{COM(2011) 866 final} 
{SEC(2011) 1520 final} 

 
 
  
 
This Impact Assessment report commits only the Commission’s services involved in its 
preparation  and  the  text  is  prepared  as  a  basis  for  comment  and  does  not  prejudge  the 
the  Commission.
final 

decision 

taken 

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any 

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TABLE OF CONTENTS 

1. 

2. 

2.1. 

2.2. 

3. 

3.1. 

3.2. 

Purpose and scope ........................................................................................................ 5 

Procedural issues and consultation of third parties ...................................................... 7 

Consultation and expertise ........................................................................................... 7 

The Impact Assessment Board..................................................................................... 8 

Policy context in the area of health security ................................................................ 9 

The Health security initiative in the context of the European security and safety 
framework at European level ....................................................................................... 9 

The current public health security framework at European and International 
level ............................................................................................................................ 11 

3.3. 

Effects of serious cross-border health threats on society ........................................... 13 

4. 

4.1. 

4.2. 

The Problems and their causes ................................................................................... 14 

Gaps in the existing health security framework at European level ............................ 14 

The problems in addressing serious cross-border health threats at EU level............. 15 

4.2.1. 

Insufficient and inconsistent preparedness and response planning between EU 
Member States for all types of serious cross-border health threats............................ 16 

4.2.1.1.  State of play................................................................................................................ 16 

4.2.1.2.  The problems, drivers and consequences................................................................... 17 

4.2.1.3.  Examples illustrating the problems – lessons learnt from pandemic (H1N1)2009.... 18 

4.2.2.  Gaps and inconsistencies in mechanisms for public health risk monitoring and 

risk assessment of biological (other than communicable diseases), chemical, and 
environmental threats ................................................................................................. 19 

4.2.2.1.  State of play................................................................................................................ 19 

4.2.2.2.  The problems, drivers and consequences................................................................... 20 

4.2.2.3.  Examples illustrating the problems ............................................................................ 21 

4.2.3. 

Insufficient and weak public health risk management measures and mechanisms 
to address biological, chemical, and environmental threats and weak risk 
communication procedures ........................................................................................ 22 

4.2.3.1.  State of play................................................................................................................ 22 

4.2.3.2.  The problems, drivers and consequences................................................................... 23 

4.2.3.3.  Examples illustrating the problems ............................................................................ 23 

4.3. 

Baseline scenario........................................................................................................ 24 

4.3.1.  Preparedness and response planning .......................................................................... 24 

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4.3.2.  Risk monitoring and assessment ................................................................................ 24 

4.3.3.  Risk management and crisis communication ............................................................. 25 

5. 

5.1. 

5.2. 

The Right of the Union to act – Subsidiarity test....................................................... 25 

Justification of public intervention............................................................................. 25 

Compliance with the principles of conferral and subsidiarity.................................... 25 

5.2.1.  Principle of conferral.................................................................................................. 25 

5.2.2.  Principle of subsidiarity ............................................................................................. 26 

5.2.2.1.  Necessity test.............................................................................................................. 26 

5.2.2.2.  Test of EU added value .............................................................................................. 27 

5.2.3.  Principle of proportionality and choice of instrument ............................................... 28 

6. 

6.1. 

6.2. 

6.3. 

7. 

7.1. 

7.2. 

7.3. 

8. 

8.1. 

8.2. 

8.3. 

9. 

10. 

11. 

12. 

Policy objectives ........................................................................................................ 29 

General objectives ...................................................................................................... 29 

Specific objectives...................................................................................................... 29 

Operational objectives................................................................................................ 29 

Policy options............................................................................................................. 30 

Option 1: Status quo / baseline scenario: Maintain the current level of activities ..... 31 

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 – no legally binding measures ................................................. 32 

Option 3: Establish a common EU legal framework covering all serious cross-
border threats to health by extending existing legislation - improved cooperation 
and legally binding measures ..................................................................................... 34 

Analysis of the impacts .............................................................................................. 37 

Option 1: Status quo/baseline scenario - maintain the current level of activities ...... 37 

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 .................................................................................................. 38 

Option 3: Establish a common EU legal framework covering all serious cross-
border threats to health by extending existing legislation - improved cooperation 
and legally binding measures ..................................................................................... 41 

Comparing the impacts of the Options....................................................................... 45 

Conclusions and proposal for implementation........................................................... 47 

Monitoring and evaluation ......................................................................................... 48 

ANNEXES AND APPENDICES .............................................................................. 50 

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1. 

PURPOSE AND SCOPE

1 

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 communicable2, 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)  will  be  covered  by  environmental  threats  throughout  this 
initiative. 

Climate change and its adverse effects show already impacts on human health as they can 
act as an amplifier of existing health problems but also contribute to new and emerging 
health threats. Climate-change-related threats of importance to human health are likely to 
increase immediate health effects from extreme weather events (heat waves, cold spells) 
and  the  distribution  of  food-borne  or  the  burden  of  water-borne  diseases,  to  affect  the 
distribution  and  the  frequency  of  vector-borne  diseases  and  cause  changes  in  the 
distribution and frequency of respiratory diseases over the coming decades. 

Serious  cross  border  health  may  range  from  mass  contamination  caused  by  chemical 
incidents to epidemics or pandemics such as those resulting from the influenza pandemic 
H1N1  in  2009,  or  SARS  (Severe  Acute  Respiratory  Syndrome)  in  2003.  These  threats 
affect  more  than  one  Member  State  in  such  a  way  that  the  morbidity  or  mortality  in 
humans is acute and/or rapidly rising in numbers, i.e. more people will fall ill or even die, 
and/or is unusual for the given place and/or time.3  

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. 

Not  all  serious  cross-border  threats  to  health  are  handled  in  a  consistent  manner  at  EU 
level.  Threats  to  health  of  radiological  or  nuclear  origin  causing  exposure  to  ionising 
radiation are dealt with by the provisions of the EURATOM treaty which constitutes the 
'lex specialis4' in relation to Article 168 of the Treaty of the Functioning of the EU and 
are therefore not covered by this initiative. 

1 

2 

3 

4 

This  initiative  implements  the  actions  set  out  in  the  Commission  staff  working  document  on 
lessons from the H1N1 pandemic and on health security in the European Union, SEC(2010) 1440 
final of 18.11.2010.  
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.  
Chronic  diseases,  injuries  due  to  transport  accidents,  spread  of  blood  borne  infectious  diseases 
through  injecting  drug  use,  the  emergence  of  new  psychoactive  substances  on  the  EU  market, 
nanotechnology,  GMOs,  and  electromagnetic  fields  are  also  not  covered  under  this  initiative. 
Existing instruments available at national and EU level that relate to the monitoring, early warning 
of and combating serious cross-border threats to health are not affected by this initiative. 
EURATOM TREATY, Articles 2b) and 30-39 

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Threats  emerging  from  biological  (other  than  communicable  diseases),  chemical  and 
environmental  origin  (such  as  e.g.  heat  waves  or  cold  spells),  are  not  addressed 
sufficiently at the EU level to protect European citizens' health appropriately. Although 
they  occur  not  as  often  as  communicable  diseases  their  impact  on  public  health  and 
society might be huge. There is an established EU framework to address communicable 
diseases  at  EU  level.  This  is  done  through  an  EU  legislation  which  allows  for  rapid 
detection  of  diseases,  notification  at  EU  level,  scientific  assessments  for  every  single 
disease  and  sustainable  structures  and  mechanisms  for  the  Member  States  to  cooperate 
effectively in managing outbreaks.  

This discrepancy in the way that serious cross border threats to health are addressed at 
EU  level  has  led  to  a  situation  where  Europe  is  better  equipped  to  face  an  infectious 
disease  outbreak  of  moderate  risk  than  to  address  the  public  health  consequences  of  a 
major incident from chemicals or biological agents e.g. caused by a criminal or terrorist 
act or as a result of an non-deliberate act or accident. 

Therefore, 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.  

In a more general strategic framework, the health security initiative will help implement 
the European Health Strategy5 and also contribute to the objectives of Europe 20206 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.7  

The  Health  Security  Initiative  will  appropriately  take  into  account  the  EU  external 
cooperation activities for health crises prevention and responses with third countries and 
explore  synergies  with 
the  numerous  bilateral  EU  assistance  and  cooperation 
programmes with a significant health component8.  

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.9 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: 

1. 

5 

6 

7 
8 
9 

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. 

2020- 

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 
and 
http://ec.europa.eu/europe2020/index_en.htm 
See details in annex 7 
See details in annex 7 
See annex 1 for article 168 of the Lisbon Treaty 

sustainable 

inclusive 

Strategy 

growth; 

smart, 

EU 

for 

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2. 

3. 

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;  

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.10.  In  this  context,  the  impact 
assessment will also elaborate on the status of the Health Security Committee11 
(HSC) and will look into ways to ensure effective communication.  

2.  PROCEDURAL ISSUES AND CONSULTATION OF THIRD PARTIES 

Organisation and timing 

An  Impact  Assessment  Steering  Group  has  been  set  up  for  inter-service  coordination 
with  the  involvement  of  the  Secretariat  General,  DG  AGRI,  BUDG,  CLIMA,  EAC, 
ECHO, EEAS, EMPL, ENER, ENTR, ENV, HOME, INFSO, JRC, JUST, MOVE, RTD, 
and TRADE. The steering group has met five times in 2011: on 25 January, 8 March, 18 
May, 20 June and 1 September 2011. 

2.1. 

Consultation and expertise12 

Stakeholders were consulted on the health security initiative in various ways, via an open 
online consultation and in face to face meetings and audio-conferences. 

The open stakeholder consultation on Health Security in the European Union took place 
between  4  March  and  31  May  2011.  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 citizens. 

In addition, separate meetings were held with the two main stakeholder groups in which 
representatives from Health Ministries discuss and coordinate health measures under the 
current  regime:  the  Early  Warning  and  Response  System  (EWRS)  network  points 
discussed the health security initiative in their meeting in February 2011 and the Health 
Security  Committee  (HSC)13  was  consulted  six  times  on  the  initiative;  the  European 
office of the World Health Organisation (WHO) is represented on both committees as an 
observer. In addition, bilateral meetings with six Member States were organised at their 
request and the initiative was also presented to the EU Health Policy Forum on 19 May 
2011. 

10 

11 
12 

13 

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. 
The name of this body might be changed in the legal proposal. 
Further  information  related  to  the  views  of  stakeholders  as  regards  the  actions  described  in  the 
options  is  included  in  Chapter  7,  policy  options.  The  detailed  analysis  of  the  consultation  is 
attached as Appendix 2 to this report. 
See annex 2 

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The key outcome of these stakeholder consultations on health security in the EU is that a majority 
of  stakeholders  argue  strongly  in  favour  of  having  all  serious  cross-border  health  threats 
included in the EU health security policy. The public consultation results show broad support for 
strengthening EU public health response in the following three areas: 

First,  preparedness  planning  should  address  all  serious  cross-border  health  threats  (i.e. 
communicable  diseases  as  well  as  chemical,  biological  and  environmental  threats).  The  EU 
should  play a  central  role  in  encouraging  national  preparedness  planning  and  in  coordinating 
national preparedness plans, for example in providing a framework to improve interoperability 
of national plans. Minimum core capacity standards should be set up on preparedness planning. 

Second,  risk  assessment  should  take  into  consideration  public  health  issues  resulting  from  all 
serious cross-border threats; a better evaluation and an EU capacity to conduct risk assessment 
would  provide  added  value  to  support  decision  makers  with  reliable,  consistent  and  timely 
scientific expertise when preparing their policies and recommendations. 

Third,  risk  management  (including  communication)  should  be  improved  for  all  serious  cross-
border  health  threats,  including  also  cross-sectoral  aspects  of  the  health  threat  in  order  to 
improve implementation of measures and reduce delays in the response.  

In this context, the Health Security Committee (HSC) is seen by national authorities as a valuable 
platform  for  public  health  risk  management  and  communication  of  the  risk  of  serious  cross-
border  health  threats.  The  strengthening  of  its  status  on  a  legal  basis  is  also  supported.  In 
addition, and outside the scope of the stakeholder consultation, the European Parliament and the 
Council  have  expressed  their  views  to  review  the  current  status  of  the  Health  Security 
Committee.14 

Furthermore, the outcome of the open consultation process on "strengthening European 
Union Preparedness on Pandemic Influenza" conducted in 2010 was also considered with 
regard to the preparedness aspects in this impact assessment. In that consultation, more 
than 70% of all respondents agreed that, as regards procurement of pandemic vaccines, 
the joint procurement of such vaccines at EU level would be desirable, as it would help 
to ensure that all Member States have timely access to vaccines in a pandemic.15 

In addition, and in relation to the procurement of medical countermeasures, especially the 
procurement  of  pandemic  influenza  vaccines  and  antivirals,  the  Commission  –  in 
response to an invitation by the Council16 – consulted experts nominated by the Health 
Security  Committee  to  explore  and  elaborate  a  number  of  possible  (joint)  procurement 
procedures and analyse their advantages and disadvantages. 

2.2.  The Impact Assessment Board 

On 5 October 2011 the Impact Assessment Board met to discuss the initiative on health 
security. In their overall opinion the board advised that the impact assessment should be 
strengthened in several respects. 

14 

15 
16 

European Parliament resolution of 8 march 2011 on evaluation of the management of H1N1 
influenza in 2009-2010 in the EU (2010/2153(INI)); details in annex 3; e.g. in September 2010 
Member States requested to "examine…options for the legal basis of the HSC"…; in the Council 
Conclusions on 'Lessons learned from the A/H1N1 pandemic'- Health Security, 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/EN/genaff/116489.pdf  
See annex 2 of appendix 1 
Council  Conclusions  on  'Lessons  learned  from  the  A/H1N1  pandemic'-  Health  Security: 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/EN/genaff/116489.pdf. 

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First,  the  report  should  provide  a  better  description  of  the  general  context  for  this  initiative, 
clearly  describing  the  existing  legal  framework  and  the  links  with  related  EU  mechanisms  for 
disaster prevention and control. Second, the form of the proposed measures, legal or otherwise, 
that the Impact Assessment is intended to support should be much clearer. Third, the extent of the 
problem, particularly in terms of Member States' preparedness should be clarified and supported 
by more concrete evidence and examples. Fourth, the content and workings of the options should 
be better explained, particularly in relation to vaccine procurement. Fifth, the costs and benefits 
of  the  proposed  measures  should  be  elaborated,  particularly  in  relation  to  potential  price 
advantages,  efficiency  gains,  and  avoidance  of  duplication  and  administrative  costs.  A  more 
concrete plan for monitoring and evaluation should be included.  

Effort has been made to amend the report taking on board the comments from the board 
before, during and after the meeting of the board on 5 October 2011. 

Further details have been provided on the policy by elaborating how the health security initiative 
will build on the existing EU mechanisms and strategies for disaster prevention and control and 
how existing gaps in public health risk management will be bridged. The content of options has 
been  specified  and  the  form  of  the  proposed  measures,  legal  or  otherwise,  has  been  clarified. 
Additional  evidence  has  been  provided  to  explain  the  extent  of  the  problem,  in  particular  as 
regards preparedness planning and business continuity. A graph has been added to the report as 
annex  18  that  describes  how  joint  vaccine  procurement  would  work  in  practice.  Particular 
attention  has  been  paid  to  better  explaining  the  financial  implications  and  the  administrative 
burden for the Commission and the Member States as the main stakeholders under this initiative. 
Efforts  have  been  made  to  include  a  more  concrete  plan  for  monitoring  and  evaluation  and  to 
shorten the core document for the impact assessment.  

3.  POLICY CONTEXT IN THE AREA OF HEALTH SECURITY 

3.1. 

The  Health  security  initiative  in  the  context  of  the  European  security  and 
safety framework at European level 

The  EU  has  a  series  of  policies,  mechanism,  instruments  to  cater  for  prevention  and 
control  of  serious  cross  border  threats  in  and  develop  capacities  to  manage  crises17.  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 few18. 

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.  Last  but  not  least,  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. 

The health security initiative is part of the overall EU crisis and management framework 
referred  to  above.  EU  strategies  and  policies  in  the  area  of  law  enforcement  and  civil 

17 
18 

See detailed information in annex 7 
For further details, please see the "Inventory of Crisis Management Capacities in Commission and 
Agencies" 

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protection  will  be  enhanced  by  the  Health  Security  Initiative:  the  EU  Internal  Security 
Strategy  makes  specific  reference  to  the  health  security  initiative;  chemical  and 
biological security in the EU as set out in the CBRN action plan will also be strengthened 
and  cooperation  with  the  Monitoring  Information  Centre  mechanism  (MIG)  in 
preparedness and response to civil disasters will also be intensified.  

The  Health  Security  Initiative  is  a  key  element  of  the  Internal  Security  Strategy19  as  it  will 
contribute  to  reinforcing  the  coordination  of  EU  risk  management  through  strengthening  the 
existing structures and mechanisms to tackle health threats. Thus, the Health Security Initiative 
will become part of a shared agenda for Member States, the European Parliament, the Council, 
the Commission, and European agencies to reinforce effective fight and prevention of serious and 
organised crime and terrorism and to strengthen resilience to natural and man-made disasters. It 
will  be  an  important  element  in  establishing  a  coherent  risk  management  policy  linking  threat 
and risk assessments to decision making as envisaged by the EU Internal Security Strategy. 

The  Health  Security  Initiative  is  also  linked  to  the  overall  European  Programme  for 
Critical  Infrastructure  Protection  (EPCIP)  framework  on 
identification  and 
designation of European Critical Infrastructure and the assessment of the need to improve 
their protection20.  

the 

To support the EU security framework and to protect citizens from serious cross border 
threats a series of alert, information and management systems, scientific committees and 
Agencies  is  already  operating  to  ensure  food  and  feed  safety,  plant  health,  medical 
products safety, consumer protection. Systems have been put in place to control chemical 
accidents,  radiological  events,  border  security  and  protection  against  crime  and 
terrorisms.  

In order to avoid overlaps with these existing disaster prevention and control structures in 
other  sectors  a  gap  analysis  has  been  carried  out.21  This  analysis  revealed  that  these 
mechanisms  do  not  address  cross  border  health  threats  preparedness  and  response  in  a 
sufficient  manner.  They  can  take  action  to  take  e.g.  products  from  the  market  and  to 
define  the  toxicity  of  chemicals;  however,  apart  from  the  instruments  in  radiological 
protection  they  do  not  provide  a  satisfactory  basis  for  decisions  on  public  health 
measures  for  the  population  to  be  implemented  in  case  of  contamination  or  poisoning. 
The  health  security  initiative  will  build  on  these  existing  instruments,  intensify 
cooperation and strengthen cooperation by establishing standard operating procedures  

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 programme22. It 

19 

20 

21 

22 

See  COMMUNICATION  FROM  THE  COMMISSION  TO  THE  EUROPEAN  PARLIAMENT 
AND THECOUNCIL: "The EU Internal Security Strategy in Action: Five steps towards a more 
secure Europe"  Brussels, 22.11.2010 - COM(2010) 673 final 
COUNCIL DIRECTIVE 2008/114/EC of 8 December 2008 on the identification and designation 
of  European  critical  infrastructures  and  the  assessment  of  the  need  to  improve  their  protection; 
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:345:0075:0082:EN:PDF, 
see 
chapter 4.2.1.1. for details; 
See  Gap  analysis  in  appendix  3  on  "Structures  for  preparedness  and  response  to  cross-border 
health threats 
See annex 9 for details on projects funded under the health programmes 

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is planned that for important elements of the initiative, specific actions will be supported 
by the future Health programme23. 

3.2.  The  current  public  health  security 

framework  at  European  and 

International level 

The  EU  has  a  well  established  policy  and  legal  framework  on  communicable  diseases 
and  the  main  purpose  of  this  Health  Security  Initiative  is  to  extend  the  protection 
provided  to  European  citizens  also  to  serious  cross  border  threats  to  health  caused  by 
biological, chemical and environmental threats. 24 

In  the  area  of  communicable  diseases,  new  diseases  and  threats  such  as  SARS,  avian 
influenza H5N1, pandemic influenza H1N1 and E. coli STEC O104 have emerged which 
are  having  a  marked  impact  not  only  in  the  health  sector  but  also  in  other  sectors  of 
society. 

As  regards  other  serious  cross-border  health  threats,  in  the  aftermath  of  the  terrorist 
attacks in 2001, and in particular the deliberate release of Anthrax toxins in the US, the 
EU health ministers decided to set up the EU Health Security Committee (HSC)25 as an 
informal  structure  for  better  coordination  of  public  health  risk  assessment  and 
management  of  other  serious  cross-border  health  threats  in  the  EU.  Initially  the  HSC 
mandate was limited to tackling bioterrorism; it has subsequently been extended to cover 
all types of public health-related crisis26 and further prolonged27. 

23 

24 

25 

26 

27 

the 

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on establishing a Health for Growth Programme, the third multi-annual programme of EU action 
in  the  field  of  health  for  the  period  2014-2020;  COM(2011)  709  final,  2011/0339  (COD); 
http://ec.europa.eu/health/programme/policy/proposal2014_en.htm 
See description of the alerting, assessment and management aspects in annex 4; Reports on the 
operation of the EWRS are prepared annually, listing the events communicated through 
system and coordination of measures undertaken 
http://ec.europa.eu/health/communicable_diseases/early_warning/comm_legislation_en.htm; Most 
recent examples of the use of the mechanism are the pandemic H1N1 event in 2009; 
http://ec.europa.eu/health/communicable_diseases/diseases/influenza/h1n1/index_en.htm#fragme
nt2; and the E. coli STEC O104 outbreak in 2011; 
http://ec.europa.eu/food/food/coli_outbreak_germany_en.htm; As regards the events treated under 
the EU Health Security Committee, annual reports are also prepared, describing the main 
activities, including coordination of management of events; 
http://ec.europa.eu/health/preparedness_response/docs/commission_staff_healthsecurity_en.pdf 
Examples of recent activity of the Committee include management of pandemic H1N1 in 2009 
and a multi state incident of anthrax contaminated heroin 
http://ec.europa.eu/health/preparedness_response/hsc/index_en.htm 
Presidency Conclusions of 15 November 2001 on 
bioterrorism:(http://europa.eu/rapid/pressReleasesAction.do?reference=PRES/01/415&format=H
TML&aged=0&lg=es&guiLanguage=en) 
Council Conclusions of 22 February 2007 on health security committee: 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf 
Council conclusions of 13 September 2010 on lessons learned from A/H1N1 pandemic – health 
security in the European Union 
http://register.consilium.europa.eu/pdf/en/10/st12/st12665.en10.pdf; see further details in annex 2 
and latest activity report: Commission staff working paper on the activities of the Health Security 
Committee during the period from November 2009 to December 2010, SEC(2011) 984 final; 
22.7.2011 

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Other  recent  cross-border  events  with  potential  health  implications  for  the  EU  have 
included  volcanic  ash  clouds  originating  in  Iceland,  the  'red  sludge'  event  in  Hungary 
caused  by  a  release  of  dangerous  chemicals  into  the  Danube  and  climate  change  more 
generally (e.g. heat waves and cold waves)28 have been addressed by the HSC.29 

The  legal  basis  for  addressing  communicable  diseases  and  other  serious  cross-border 
health  threats  has  been  reinforced  with  the  entry  into  force  of  the  Lisbon  Treaty30  in 
December 2009. The new provisions state that the EU has been empowered in particular 
to  perform  the  action  of  "monitoring,  early  warning  of  and  combating  serious  cross-
border  threats  to  health".  The  EU  can  now,  in  addition,  take  measures.  Under  the 
previous  article  in  the  Treaty  establishing  the  European  Community  (Article  152,4)  it 
was  only  possible  to  provide  for  incentive  measures31  or  adoption  of  Council 
Recommendations32 to coordinate Member States' approaches.  

In addition, at international level, the International Health Regulations (IHR), a legally-
binding  new  framework  for  the  coordination  of  the  management  of  events  that  may 
constitute a public health emergency of international concern, cover all hazards including 
communicable  diseases  and  other  health  threats.  33  They  impose  an  obligation  on  each 
Member  State  to  individually  build  core  capacities  for  surveillance  and  response  to  all 
Public Health Emergencies of International Concern, as well as mechanisms for bilateral 
reporting  and  collaboration  in  information  sharing  between  the  WHO  and  the  Member 
States concerned. Under the IHR, the WHO may issue recommendations on public health 
measures to be taken in certain conditions by Member States which can be inconsistent 
with  public  health  measures  undertaken  under  the  EU  legislation.  For  example  during 
pandemic  H1N1  the  change  in  the  pandemic  phase  was  declared  by  the  WHO  without 
consultation  with  the  EU  despite  the  fact  that  EU  pharmaceutical  legislation  requires 
such a signal to launch its fast track procedure for marketing authorisation of vaccines. 
Similarly, a possible recommendation regarding quarantine under the IHR could interfere 
with free movement within the EU if done without consultation at EU level. 

Moreover,  in  several  Council  meetings,  Health  Ministers  have  repeatedly  called  for  a 
review of the health security framework, including options for a legal basis of the Health 
Security  Committee,  the  need  for  reviewed  pandemic  preparedness  planning  and  a 
proposal  for  a  mechanism  for  joint  procurement  of vaccines and antiviral  medication34. 
The European Parliament has also recently supported a proposal for strengthened health 
security at European level35. 

28 

29 
30 
31 
32 

33 

34 
35 

The Commission has adopted in 2009 a White Paper on "Adapting to climate change: Towards a 
European framework for action" and a Commission Staff Working Paper on Human, Animal and 
Plant  Health  impacts  of  Climate  change  accompanying  the  White  Paper  on  Adaptation  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0147:FIN:EN:PDF; 
http://ec.europa.eu/health/ph_threats/climate/docs/com_2009-147_en.pdf 
See overview in annex 6 
See annex 1 and also http://europa.eu/lisbon_treaty/full_text/index_en.htm 
such as support for projects under the health programmes 
For  example  council  recommendations  on  seasonal  influenza  vaccinations,  antimicrobial 
resistance and nosocomial infections  
See  annex  5;  IHR  entered  into  force  on  15  June  2007  and  require  gradual  implementation  by 
2016;http://who.int/ihr/en/ 
See annex 3 for details on Council requests. 
European  Parliament  resolution  of  8  march  2011  on  evaluation  of  the  management  of  H1N1 
influenza in 2009-2010 in the EU (2010/2153(INI)); 

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It  is  against  the  background  of  these  new  developments  and  legal  possibilities  that  the 
current EU policy framework on public health security can be reviewed. 

3.3.  Effects of serious cross-border health threats on society 

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. 

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

EN 

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The Commission has also proposed an additional budget of EUR 15 million with the purpose of 
helping promotional programmes of professional organizations for fresh fruit and vegetables in 
the single market and in third countries. 

These  examples36  also  show  that  impacts  on  society,  for  example  as  regards  free 
movement or economic losses and financial consequences, can be significant, in addition 
to their impact on the health of citizens. 

This underlines the need for a multi-sectoral approach to public health emergencies and 
also shows that all types of serious cross-border threats to health need to be included in a 
comprehensive health security framework at EU level. 

A  further  characteristic  of  today's  crises  is  the  strong  involvement  of  the  media,  the 
growing  influence  of  social  media,  and  the  fact  that  information  is  transmitted  rapidly 
and  is  publicly  accessible.  Therefore  communication  has  become  an  essential  aspect  of 
crisis  management  as  national  and  EU  level  health  authorities  have  to  communicate 
effectively, rapidly, and in a transparent manner. 

4.  THE PROBLEMS AND THEIR CAUSES 

4.1. 

Gaps in the existing health security framework at European level 

In any health crisis situation the level of preparedness, the quality of risk assessment and 
the  appropriate  response  are  decisive  in  terms  of  coping  with  the  situation37.  Member 
States are in charge of preparedness planning, crisis management and of the organisation 
of  response  and  recovery  at  national  level.  However,  cross-border  events  need  to  be 
addressed in a coordinated manner at EU level in order to contain and mitigate the health 
danger for citizens and ensure that public health consequences are properly managed.  

The different types of serious cross-border threats to health are not treated in a consistent 
manner  at  EU  level.  Threats  emerging  from  biological,  chemical  and  environmental 
events are not addressed in the same way as those from communicable diseases.  

For  serious  cross-border  health  threats  arising  from  communicable  diseases,38  the 
Member  States,  the  Commission  and  the  scientific  EU  agencies  can  build  on  formal 
structures and mechanisms at EU level that have proved their effectiveness for more than 
a decade39.  

Communicable  diseases  are  notified  on  a  daily  basis  via  the  EWRS  system,  from  June  2007  to 
July  2011  785  cases  of  communicable  diseases  with  a  cross  border  implications  were  notified. 
Given the EU tailor made application of the system more notification are alerted than under the 
International Health Regulations40 

36 
37 
38 

39 
40 

Further examples are provided in annex 6 
See Glossary in Appendix 1 for further explanation 
See  annex  4  for  description  of  existing  legal  framework  for  communicable  diseases,  Decision 
2119/98 and ECDC founding regulation. 
See details on the functioning of the system and examples in the information box under 3.1. 
See information in annex 11 

EN 

14 

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However, there is currently no structure, operational tool or procedure that enables joint 
actions between Member States in order to ensure equitable access to medical counter-
measures. 

There  are  also  other  serious  cross-border  threats  to  health  emerging  from  biological, 
chemical and environmental events, which cannot be addressed due to the lack of an EU 
legal framework.  

Cross border threats to health caused by chemical, biological and environmental events are not 
reported  as  often  as  communicable  diseases41.  Based  on  IHR  notifications  we  can  expect  on 
average 5-6 such events per year42. Under EU tailor made criteria for these incidents the threats 
notified - based on experience with alerts for communicable diseases - could amount to 20 -25 
per year. The frequency of such events is likely to increase due to increases in global travel and 
trade, climate change and latent risk of criminal and terrorist attacks.  

There is no possibility for a coordinated response with dedicated public health follow up 
measures or agreements on prophylaxis and treatment in order to protect the health of the 
EU citizens affected by those events. At EU level these types of crises are dealt with – as 
far as public health is concerned - on a case by case and ad-hoc basis43. 

There  are  structures  in  place  at  national,  EU  and  international  level  which  cover  some 
aspects  of  preparedness,  risk  monitoring,  risk  assessment  and  risk  management  for 
serious cross-border threats which may also have public health consequences, e.g. in the 
field of food and feed safety, animal health, border security and chemical accidents. An 
internal  analysis44  carried  out  by  Commission's  services  to  support  this  impact 
assessment  indicates  that  these  structures  do  not  systematically  address  comprehensive 
health  protection  of  the  population;  nor  do  they  cover  specific  public  health  measures 
that might be necessary in order to respond to risks and/or to the follow-up of events. 

The  Health  Security  Committee  (HSC)  is  currently  the  instrument  which  exists  at  EU 
level  to  discuss  the  management  of  health  crisis  caused  by  chemical,  biological  and 
environmental events. However, it is informal and has no legal mandate. 

The current situation therefore does not make fully use of the new competences given to 
the EU under the Lisbon treaty i.e. to allow the European Parliament and the Council to 
adopt measures designed to protect and improve human health. 

4.2.  The problems in addressing serious cross-border health threats at EU level45 

The following chapters will describe in more detail the problems related to preparedness, 
risk assessment and risk management at European level, in particular: 

• 

insufficient and inconsistent preparedness and response planning between 
EU Member States for all types of serious cross-border health threats; 

41 

42 
43 

44 
45 

This lesser frequency may, at least partially, be due to different monitoring and lack of detection 
tools. 
See information in annex 11  
e.g.  the  event  of  anthrax  contaminated  heroine  in  2010  necessitated  support  from  Europol  and 
EMCDDA 
See details in appendix 3: structures for preparedness and response to cross-border health threats " 
Problems and public health consequences are illustrated in annex 12. 

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• 

• 

gaps and inconsistencies in mechanisms for public health risk monitoring 
and  risk  assessment  of  chemical,  biological  (other  than  communicable 
diseases) and environmental threats; 

insufficient  and  weak  public  health  risk  management  measures  and 
mechanisms  to  address  biological  (other  than  communicable  diseases), 
chemical,  and  environmental  threats  and  weak  risk  communication 
procedures; 

4.2.1. 

Insufficient  and  inconsistent  preparedness  and  response  planning  between 
EU Member States for all types of serious cross-border health threats 

4.2.1.1.  State of play 

The level of preparedness, the types of threats covered the approaches on inter-sectoral 
preparedness  and  the  minimum  standards  applied  across  Member  States  differ  because 
this  planning  is  currently  conducted  on  a  voluntary  basis  at  EU  level.  There  is  an 
obligation  for  Member  States  to  develop  and  implement  core  capacity  requirements 
under the International Health Regulations (IHR), but there is no common EU approach 
to these requirements and no EU specific criteria given that the EU is not a contracting 
party  to  the  IHR.  Therefore,  Member  States  are  under  no  obligation  to  implement  the 
IHR standards in a manner that is compatible at EU level or to inform the Commission 
and other Member States of their state of preparedness. 

Public health depends strongly on a number of critical sectors such as energy, transport, 
tele-communication, water and finance.  

Hospitals  for  example  cannot  function  properly  if  electricity  fails  or  if  doctors  are  unable  to 
proceed to work due to the break down of public transport. On the other hand, essential public 
services such as water or energy supply may not work because a large number of staff falls sick.  

The  World  Health  Organization  (WHO)  has  addressed  the  need  for  improved 
coordination of such critical sectors under the "whole society approach"46.  

Health is also an element of the overall European Programme for Critical Infrastructure 
Protection  (EPCIP)  framework.  On  8  December  2008  the  Council  adopted  Directive 
2008/114/EC47  on  the  identification  and  designation  of  European  Critical  Infrastructure 
and the assessment of the need to improve their protection.  

In  the  area  of  communicable  diseases,  preparedness  planning  exists  in  particular  for 
pandemic influenza48. However, it is not known to what extent sectors other than health 

46 

47 
48 

in 

the 

non 

July 

health  Sector,  Geneva, 

WHO,  Whole-of-society  pandemic  readiness  -  WHO  guidelines  for  pandemic  preparedness  and 
response 
on 
line:http://www.who.int/influenza/preparedness/pandemic/2009-
0808_wos_pandemic_readiness_final.pdf; Detailed information is provided in annex 8. 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:345:0075:0082:EN:PDF 
At  international  level  WHO  has  developed  a  pandemic  influenza  preparedness  plan.  The 
Commission  has  developed  in  2005  a  set  of  communications  establishing  the  EU  Pandemic 
Influenza Preparedness and Response Plan and Member States also have arrangements in place. 
However workshops undertaken by ECDC and WHO-Europe with the Commission in September 
2011 revealed that most countries had found their pandemic plans wanting in the 2009 pandemic 
and they were now updating and strengthening their plans and preparedness accordingly. WHO is 

available 

2009, 

18 

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16 

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have integrated pandemic preparedness in their business continuity plans. There are also 
variations  at  national  level  in  terms  of  implementation  of  the  preparedness  plans. 
Examples  of  studies  at  EU  and  international  level  on  the  state  of  the  art  of  pandemic 
preparedness planning, in particular on business continuity planning, are summarised in 
annex 849.  

As  regards  generic  preparedness,  the  Commission  has  published  the  "Strategy  for 
Generic Preparedness Planning, Technical guidance on generic preparedness planning for 
public  health  emergencies"50  for  all  types  of  health  threats.  However,  there  is  no 
mechanism in place to ensure its implementation in all Member States. 

4.2.1.2.  The problems, drivers and consequences 

Discrepancies  in  the  level  of  preparedness  planning  across  the  EU  lead  to  incoherent 
strategies,  divergent  standards,  inconsistent  procedures  and  methodologies.  Member 
States are differently equipped to respond to threats as regards, for example, laboratory 
infrastructure needed for the diagnosis of cases, or availability of staff. In addition, not 
all critical sectors in society are sufficiently prepared for an emergency which might have 
an  impact  on  public  health  or  vice  versa51.  Lower  levels  of  preparation  in  the  Member 
States  affected  and  in  critical  sectors  will  weaken  and  delay  the  EU  response  capacity 
and negatively impact the situation in other Member States. 

These  different  levels  of  preparedness  in  the  Member  States  may  lead  to  unequal 
treatment and access to medical care for citizens, endanger activities intended to ensure 
the containment and mitigation of  a public health  incident  and, importantly,  potentially 
lead to an increase in mortality and morbidity rates at EU level if a major incident of a 
cross-border nature were to hit the EU. 

Without  coordination  at  EU  level,  public  health  measures  will  not  be  supported  by 
established procedures and mechanisms, but managed on an ad hoc basis by individual 
Member  States,  at  best  following  advice  provided  by  the  Health  Security  Committee. 
Member  States  may  e.g.  adopt  different  mutually  counterproductive  measures,  e.g. 
related to border closure, impose quarantine, or issue divergent travel advice. The result 
will be crisis management at EU level that is ineffective and inefficient; public trust in 
national authorities and in those EU institutions with public health responsibilities will be 
undermined and, lastly, there may be important repercussions on other EU policies (free 
movement of persons and products, energy, transport).  

not planning to update its plans in the immediate future and therefore it is important that collective 
EU action is taken to prevent EU Member State plans diverging.  
The European Centre for Disease Prevention and Control (ECDC) has facilitated systematic self 
assessments  of  pandemic  preparedness  in  the  Member  States.  In  order  to  facilitate  sharing  of 
sensitive  information,  Member  States have agreed  to  the  terms  of reference for  these studies on 
the  basis  of  the  understanding  that  only  aggregated  data  would  be  published  and  that  Member 
States would not be identified.  
Commission Communication on strengthening coordination on generic preparedness planning for 
public health emergencies at EU level of 28 November 2005 (COM(2005) 605 final): http://eur-
lex.europa.eu/LexUriServ/site/en/com/2005/com2005_0605en01.pdf; 
http://ec.europa.eu/health/preparedness_response/docs/gpp_technical_guidance_document_april2
011.pdf 
See annex 8 for further details 

49 

50 

51 

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Public health measures taken during a pandemic have the potential to cause unintended 
adverse  effects  on  other  parts  of  society  and  the  economy.  This  may  result  from 
restrictions  on  daily  activity,  for  example  as  a  result  of  a  social  distancing  policy  such 
that schools, business and  government offices close  for a period of time in an effort to 
reduce transmission, and the cancellation of mass gatherings. 

Therefore increased multi-sectoral preparedness, i.e. preparedness not only of the health 
sector but also of other critical sectors in society such as energy, transport, ICT, just to 
name  a  few,  is  needed  both  to  support  the  public  health  response  and  to  mitigate  the 
overall effect of the pandemic on society.  

As  regards  procurement  of  medical  countermeasures  –  in  particular  when  demand 
outstrips  supply  –  individual  procurement  increases  the  competition  between  Member 
States.  Contractual  confidentiality  clauses  imposed  by  suppliers  prevent  the  pooling  of 
expertise and exchange of best practices, thereby considerably weakening the purchasing 
power of the Member States and creating unfavourable contractual conditions. Together 
with  restrictions  in  health  budgets,  such  conditions  may  cause  some  Member  States  to 
procure an insufficient amount of medical countermeasures. This considerably weakens 
the  EU's  preparedness  against  serious  cross-border  threats  to  health,  as  Europe's 
preparedness is only as strong as its weakest link. 

4.2.1.3.  Examples  illustrating  the  problems  –  lessons  learnt  from  pandemic 

(H1N1)2009 

The management of Pandemic Influenza H1N1 was thoroughly evaluated52.  

Lessons learnt at EU level and key messages endorsed by the Health Security Committee include 
the following53:Member States, the Commission and EU Agencies continue to 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.  

Non-equitable access to pandemic influenza vaccines during the H1N1(2009) pandemic was due 
to weak purchasing power of Member States 54. 

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 

52 

53 

54 

EN 

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; 
Assessment 
of 
http://ec.europa.eu/health/communicable_diseases/docs/assessment_vaccine_en.pdf 

on  EU  wide 

pandemic 

strategies 

vaccine 

report 

25.8.2010 

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different dates across the EU countries. 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.  

The  procurement  of  pandemic  influenza  vaccines  is  challenging  for  a  number  of  reasons  that 
characterise  this  specific  market:  Pandemic  influenza  vaccines  cannot  be  manufactured  / 
stockpiled in advance of a pandemic, because the specific virus is needed for the production of 
the antigen in the vaccine. Pandemic influenza vaccines are usually manufactured using the same 
facilities as for seasonal influenza vaccines. The production capacity of these facilities is much 
lower than the global demand for pandemic influenza vaccines during a pandemic. The pandemic 
influenza  market  is  characterised  by  scarce  competition,  as  only  few  vaccine  manufacturers 
(usually with long-standing expertise in the manufacture of seasonal influenza vaccines) have the 
capacity  and  expertise  to  offer  a  pandemic  influenza  vaccine  with  a  valid  marketing 
authorisation when a pandemic emerges 

As a result, 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 evaluation55 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 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. 

Finally, the report of the European Parliament on evaluation of the management of H1N1 
influenza  2009-201056  highlights  major  differences  between  the  preparedness  of  EU 
Member  States,  and  the  lack  of  genuine  cooperation  weakened  the  EU's  overall 
preparedness. The lack of a solidarity and brokerage mechanism between Member States 
and  the  absence  of  prior  purchase  agreements  in  several  Member  States  were  the  main 
factors undermining the EU's better preparedness. 

4.2.2.  Gaps and inconsistencies in mechanisms for public health risk monitoring 
and  risk  assessment  of  biological  (other  than  communicable  diseases), 
chemical, and environmental threats  

4.2.2.1.  State of play 

Risk  monitoring  and  assessment  for  communicable  diseases  is  well  established  at 
European  level.  Decision  2119/98/EC  established  the  epidemiological  surveillance 
system, and  the European Centre for Disease Prevention and Control (ECDC) provides 
robust, reliable and scientific assessment for communicable diseases. 

55 
56 

http://ec.europa.eu/health/communicable_diseases/docs/assessment_vaccine_en.pdf  
Report of the European Parliament on evaluation of management of H1N1 influenza 2009-2010 
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+REPORT+A7-2011-
0035+0+DOC+PDF+V0//EN&language=EN 

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As regards other serious cross-border threats at EU level, there are a number of agencies, 
networks  and  structures  which  address  monitoring  and  identification  of  serious  cross-
border health threats, including reporting and risk assessment57.  

To inform this impact assessment, an analysis has been performed to review which of the 
structures touch on public health and could provide for public health risk assessment.58 
However, the outcome of this analysis and the feedback from other Commission services 
participating  in  the  inter  service  steering  group  indicate  that  these  structures  address 
primarily  safety  or  quality  aspects  (e.g.  related  to  chemical  or  environmental  risks,  or 
consumer  safety).  They  do  not  address  public  health  protection  in  a  systematic  and 
comprehensive  manner.  Moreover,  they  also  do  not  provide  options  for  specific  public 
health  measures  that  might  be  necessary  to  manage  risks  and  to  ensure  an  effective 
follow-up of events. In addition, many of the structures are operated without informing 
or  linking  with  authorities  and  agencies  responsible  for  public  health  in  the  Member 
States or at EU level. 

At international level, the threat notification and risk assessment is conducted through the 
International  Health  Regulations  on  a  bilateral  basis  between  WHO  and  individual 
Member  States.  Risk  assessment  is  not  exhaustive  from  the  public  health  perspective 
(additional information is missing, such as means of treatment for humans, clinical and 
laboratory  detection  criteria,  etc.).  Obviously  the  lack  of  coordination  at  EU  level  may 
endanger a quick and appropriate response to the threat. Risk assessment tools have been 
established  by  the  Commission  to  address  these  gaps  and  to  monitor  the  public  health 
consequences of threats other than communicable diseases (e.g. RAS-CHEM). However, 
there  are  no  sustainable  resources  in  Member  States  to  operate  these  systems  and  the 
activities are voluntary in nature. 

4.2.2.2.  The problems, drivers and consequences 

Although there are a variety of notification and alert systems in place for different threats 
at  EU  level,  these  are  not  systematically  linked  to  EU  public  health  authorities. 
Notifications  by  Member  States  under  the  International  Health  Regulations  cover  all 
serious  cross-border  threats  to  health,  but  the  criteria  for  such  notifications  are  not 
necessarily  appropriate  for  the  EU  level,  given  the  existence  of  a  common  external 
border, freedom of movement and common policies. There are no criteria and no similar 
notification obligations at EU level, and this leads to a lack of awareness about potential 
threats to public health. 

National risk assessments exist, but they may not be consistent when considered from the 
EU perspective, and there is currently no well established mechanism for a coordinated 
approach  at  EU  level.  The  lack  of  public  health  risk  assessment  at  EU  level  leads  to 
discrepancies  in  the  evaluation  of  the  danger  level  of  a  given  threat,  duplication  of 
assessments  between  Member  States  and  inconsistent  interventions  at  EU  level.  In 
addition,  such  a  situation  can  also  lead  to  inefficient  use  of  the  limited  resources 
currently available and may delay appropriate public health measures, which could put at 
risk  the  overall  response  at  EU  level.  Ultimately,  the  negative  impact  of  this  situation 
might result in higher levels of morbidity and mortality, i.e. more people fall sick or will 
die. It may also endanger common EU policies owing to the impact of health effects on 

57 
58 

For detailed information see annex 7 
See appendix 3: structures for preparedness and response to cross-border health threats 

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other  critical  sectors  of  the  economy  and  society  (e.g.  breakdown  of  the  transport  or 
energy sectors). 

Importantly, any evaluation of risks which is not comprehensive or is inappropriate may 
lead  to  unclear  communication  and  may  undermine  public  confidence  in  the  measures 
proposed or taken by public health authorities. 

4.2.2.3.  Examples illustrating the problems 

Insufficient notification of threats at EU level 

Potential events involving biological agents are not addressed robustly at EU level. Toxins, such 
as Ricin59, are not covered by any notification system.60.  

Unavailability of rapid risk assessment 

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 2008.61 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 symptoms62.  

59 

60 

61 

62 

http://www.bmj.com/content/326/7381/126.1.full 
http://www.health.state.ny.us/environmental/emergency/chemical_terrorism/ricin.htm 
http://bioterroreurope.wikispaces.com/file/view/Biological+Weapons+and+Bioterrorism+ 
Preparedness%3A+Importance+of+Public+Heath+Awareness+and+International+Cooperation; 
http://www.ndma.gov.pk/Docs/BioTerrorismGuideINTERPOL.pdf; http://catalogue.sipri.org/cgi-
bin/koha/opac-detail.pl?biblionumber=75917 
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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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.  

4.2.3. 

Insufficient  and  weak  public  health  risk  management  measures  and 
mechanisms to address biological, chemical, and environmental threats and 
weak risk communication procedures  

4.2.3.1.  State of play  

The  Health  Security  Committee  (HSC)  is  currently  the  structure  at  EU  level  which 
manages  serious  cross-border  health  threats.  In  terms  of  preparedness,  the  HSC's 
mandate provides a platform for the informal sharing of information and experience on 
preparedness  and  crisis  management  strategies,  advising  Health  Ministers  and  the 
European  Commission  on  preparedness  and  response  planning  and  also  coordinating 
emergency  planning  at  the  EU  level.  In  a  public  health  crisis,  the  HSC  can  be  used  to 
coordinate  crisis  responses  by  Member  States  and  the  Commission.  Under  the  HSC  a 
network  of  communicators  from  the  Member  States  and  the  Commission  share 
information  about  their  messages  to  the  general  public.  The  HSC  also  facilitates  and 
supports  coordination  and  cooperation  efforts  generally  on  health  security,  as  well  as 
initiatives at EU and international level, and it helps contribute to the implementation of 
these initiatives at national level. The public health authorities in the Member States are 
represented  in  this  Committee  at  the  level  of  middle  management.  The  Commission 
provides the secretariat of the Health Security Committee and chairs the meetings. The 
Commission  can  prepare  and  table  recommendations  and  advice,  but  does  not  propose 
any measures. 

Given  the  informal  status  of  the  Health  Security  Committee,  the  involvement  and 
commitment  of  Member  States  is  voluntary.  Agreed  positions  are  difficult  to  achieve 
and,  even  if  they  are  issued,  Member  States  are  not  obliged  to  take  them  into 
consideration  in  their  public  health  response  in  a  crisis  situation.  As  the  HSC  does  not 
have a formal footing, there are no mechanisms in place to ensure that all Member States 
comply with the HSC's advice. This relative weakness has also led in recent years to a 
development  whereby  the  level  of  attendance  by  some  Member  States  has  been  at  a 
technical rather than a strategic level. Furthermore, the HSC has neither the authority nor 
the mandate to effectively coordinate risk management at EU level and with all Member 
States. 

At  international  level  the  International  Health  Regulation  (IHR)  covers  the  risk 
management of public health emergencies of internal concern independently of the nature 
and origin of the threat. The IHR does not take into account the "acquis communautaire". 
If the threat is serious enough, its action may include restrictions on the free movement 
of  goods  and  persons,  border  controls,  travel  restrictions,  and  limiting  of  personal 
freedom (quarantine).  

Finally,  the  information  sharing  process  related  to  the  event  is  dealt  with  by  Member 
States and WHO bilaterally, thereby excluding other Member States and the Commission 
from the process. 

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4.2.3.2.  The problems, drivers and consequences 

Serious  cross-border  health  threats  are  unavoidable  and  can  have  a  major  consequence 
both on health and on other sectors of society and the economy (see annex 6). It is the 
competence of Member States to manage their health services and address health crises at 
national level. However, the mechanisms for risk management at EU level are inadequate 
and there is an absence of clear mandates, responsibilities and defined scope for decision 
making on the public health response. 

This leads to insufficient coordination of the public health response and no cross-sectoral 
interlinking  for  decision  making  processes  in  public  health.  Even  agreements  on 
minimum  common  denominators  are  difficult  to  reach,  with  the  risk  of  delays  in  the 
response to the health emergency and in implementing measures.63 

Although a network of communicators has been established under the HSC, the lack of a 
formal mechanism for agreeing consistent messages to the public and target populations 
does not allow an efficient information process at EU level and undermines the trust and 
credibility 
than 
communicable diseases) and environmental threats. 

to  chemical,  biological  (other 

the  public  health  response 

in 

4.2.3.3.  Examples illustrating the problems 

Lack of coordination of public health measures 

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  coverage64,  on  travel  advice65 and on  school 
closures66 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 vaccines.67 

There was also 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. 

Insufficient linkage of public health risk and crisis management across sectors - examples 

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). 

63 

64 

65 

66 

67 

E.g. in 2009 it took several weeks in 2009 to get agreement in the Health Security Committee on 
common statements relating to vaccination, travel advice and school closures: 
http://ec.europa.eu/health/communicable_diseases/diseases/influenza/h1n1/index_en.htm#fragme
nt2 
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 

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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). 

Weak communication strategies 

There were difficulties in communicating with health professionals and the public on the need for 
pandemic vaccination in the 2009 H1N1 pandemic.68 

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. 

4.3.  Baseline scenario 

The  situation  as  described  in  chapter  4.2.  would  continue  and  no  substantial 
improvements  to  the  way  in  which  serious  cross-border  threats  to  health  are  addressed 
across  the  EU  can  be  expected.  The  provisions  of  Article  168  TFEU  would  not  be 
implemented  in  respect  of  monitoring,  early  warning  of  and  combating  serious  cross-
border  threats  to  health,  and  no  additional  measures  at  EU  level  would  be  taken. 
Nonetheless, the baseline scenario is considered as an option and the detailed impacts of 
this scenario will therefore be thoroughly analysed under option 1. 

4.3.1.  Preparedness and response planning 

As there is currently no commitment in place for Member States to implement coherent 
preparedness  planning,  the  situation  across  the  EU  would  remain  as  varied  and  multi-
layered  as  it  is  now.  This  means  that  it  would  be  impossible  to  ensure  a  coherent  and 
efficient public health response to serious cross-border health threats at EU level. 

There would be no guarantee that in a serious cross-border public health event Member 
States  would  have  an  equitable  supply  of  medical  countermeasures  at  affordable  prices 
and  under  equitable  contract  conditions.  This  would  lead  to  putting  particularly 
vulnerable  groups,  such  as  children  and  persons  with  underlying  chronic  conditions,  at 
risk of infection. 

In  the  absence  of  an  improved  coordination  of  EU  preparedness,  there  would  be  no 
proper linkage between the International Health Regulations (IHR) and the way in which 
serious cross-border threats to health are addressed in the EU. This would represent a risk 
to  public  health  management  at  EU  level  given  the  differing  and  inconsistent 
implementation  by  Member  States  of  minimum  core  capacities  for  surveillance  of  and 
response to public health emergencies of international concern. 

4.3.2.  Risk monitoring and assessment 

The present gaps in risk assessment for serious cross-border health threats of chemical, 
biological  (other  than  communicable  disease),  or  environmental  origin  would  persist. 
Coordination  of  risk  assessments  between  different  sectors,  and  with  Member  States, 
would  not  take  place.  In  this  situation,  no  comprehensive  and  coherent  evaluation  of 

68 

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

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public  health  risks  could  be  assured,  and  serious  detrimental  effects  on  morbidity  and 
mortality would be likely to result. 

4.3.3.  Risk management and crisis communication 

At  EU  level,  cooperation  in  the  Health  Security  Committee  on  the  follow  up  of  public 
health consequences of serious cross-border health threats would continue to be based on 
informal and ad hoc grounds. The consequence of this would be an ongoing likelihood 
that  minimum  consensus  on  risk  management  would  not  be  reached  and  that  the 
responses of Member States would be inconsistent or incoherent at EU level. The system 
would  remain  voluntary  in  nature  with  no  legal  obligations  for  coordination  of  public 
health risk management. Hence, existing shortcomings would not be addressed. 

Collective agreement between Member States on shared communication activities would 
remain very difficult to reach. Conflicting messages may lead to a lack of trust in public 
health  measures,  undermine  the  acceptance  of  such  measures  by  the  public,  jeopardize 
confidence  in  the  competence  of  public  health  authorities,  and  endanger  the  efficient 
management of an event. 

5.  THE RIGHT OF THE UNION TO ACT – SUBSIDIARITY TEST  

5.1. 

Justification of public intervention 

With the entry into force of the Lisbon Treaty, the EU has been empowered to support, 
coordinate  or  supplement  the  action  of  Member  States  in  the  area  of  protection  and 
improvement of human health (Article 6a TFEU). The Treaty states that EU action shall 
be directed towards improving public health, preventing physical and mental illness and 
diseases, and obviating sources of danger to physical and mental health, and in particular 
"monitoring,  early  warning  of  and  combating  serious  cross-border  threats  to  health" 
(Article 168 TFEU). 

There is a discrepancy between the fundamental goal of the EU to ensure a high level of 
human health protection and the existing situation, which does not guarantee such a high 
level in the event of serious cross-border threats to health. 

In  addition,  there  is  a  need  to  avoid  market  failures,  in  particular  to  ensure  that 
appropriate  linkages  are  established  between  preparedness  for  the  health  sector  and  for 
other  sectors  which  may  be  affected  in  an  event  and  vice  versa,  and  to  ensure  that 
operation  of  the  internal  market  and  common  EU  policies  such  as  the  maintenance  of 
essential  services,  and  circulation  and  availability  of  essential  goods,  are  assured. 
Furthermore,  imperfect  information  flows  regarding  health  crises  may  endanger  the 
decision  making  process  and  therefore  endanger  public  health,  while  at  the  same  time 
undermining the continuity of the internal market. 

5.2.  Compliance with the principles of conferral and subsidiarity 

5.2.1.  Principle of conferral  

In the area of protection and improvement of human health, the EU acts within the limits 
of  its  competences  laid  down  in  the  Treaties  by  supporting,  coordinating  or 

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supplementing  the actions  of  Member States, without superseding their competences in 
the area of public health (Articles 2.5 and 6a TFEU)69. 

EU  action  shall  encourage  cooperation  between  the  Member  States  and,  if  necessary, 
lend  support  to  their  action,  while  fully  respecting  the  responsibilities  of  the  Member 
States for the organisation and delivery of health services and medical care (Article 168 
TFEU). 

Finally, as regards the cross-sectoral dimension of public health matters, the EU should 
take  into  account  requirements  linked  to  the  promotion  of  a  high  level  of  protection  of 
human  health  while  defining  and  implementing  its  policies  and  activities  (Article  9 
TFEU and Article 35 of the Charter of Fundamental Rights of the European Union). 

5.2.2.  Principle of subsidiarity  

Subsidiarity  is  respected  because  the  action  of  "monitoring,  early  warning  of,  and 
combating  serious  cross-border  threats  to  health"  cannot  be  undertaken  by  individual 
Member  States  alone  and  therefore  needs  to  be  addressed  at  EU  level.  The  subsidiary 
principle  has  two  aspects:  the  necessity  test  and  the  EU  added  value  test;  both  are 
described below. 

5.2.2.1.  Necessity test 

'Serious  cross-border  threats  to  health'  and  'public  health  emergencies  of  international 
concern', by their nature, have trans-national implications (such as the need for coherent 
preparedness  planning,  or  adequate  risk  assessment  and  risk  management  procedures) 
which Member States cannot  satisfactorily  achieve individually. 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 
comparable  and  coordinated  to  contain  further  spread  and  minimise  the  consequences. 
Less prepared Member States and critical sectors will weaken and delay the EU response 
capacity and negatively impact the situation in other Member States. In addition, the lack 
of co-ordination could result in disproportionate measures that could disrupt the internal 
market considerably. 

Dealing with the potential public health consequences across Member States, therefore, 
necessitates  coordinated  action  at  EU  level  to  ensure  that  all  citizens  independent  from 
their origin or residence can benefit from a high level of health protection. The system in 
place at European level for public health crisis management is not sufficient as explained 
under the baseline scenario; it is poorly coordinated by the existing systems in place and 
based  on  weak  and  voluntary  grounds.  In  addition,  there  is  no  appropriate  link  to 
associate  cross  border  crisis  management  with  international  requests  and  obligations 
under the International Health Regulations.  

This  weakness  related  to  coordinated  EU  action  for  monitoring,  early  warning  and 
combating  of  serious  cross-border  threats  to  health  is  in  conflict  with  the  fundamental 
goals of the Treaty to ensure a high level of human health protection. 

69 

With  the  exception  of  the  common  safety  concerns  in  the  public  health  matters  for  the  aspects 
defined  in Article 168(4) TFEU, which follow under shared competence between the EU and the 
Member States (see Article 4(2) (k) TFEU). 

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In addition, actions undertaken by one Member State alone may significantly damage the 
interests  of  other  Member  States  (e.g.  distortion  or  disruption  of  the  internal  market, 
limitations  on  equal  access  to  medical  countermeasures,  restrictions  on  freedom  of 
persons,  interruption  of  trade  and  critical  services  such  as  transport,  information 
technologies, health care, energy, banking). Consultation at EU level before adoption of 
public health measures at national level would avoid negative impacts on health sectors 
and other crucial sectors in the different Member States. 

5.2.2.2.  Test of EU added value  

In addition to the cross-border aspects of such threats, they often affect crucial sectors of 
the  economy  and  society.  Many  of  these  sectors  are  of  exclusive  or  shared  EU 
competence and therefore require the involvement of different stakeholders, namely the 
Commission,  EU  Agencies  and  national  competent  authorities.  For  instance,  under  the 
exclusive  competence  of  the  EU  a  health  emergency  may  affect  the  sustainability  of 
customs  activities  at  the  external  frontier,  impact  competition  policy  by  excluding 
economic  operators  and  disrupt  the  operation  of  commercial  policy.70  Under  shared 
competence  a  number  of  events71  provide  clear  examples  that  health  emergencies  can 
impact  on  the  transport  sector,  agriculture,  environment,  energy,  internal  market  and 
freedom and security and common safety concerns in public health matters (food safety, 
pharmaceuticals, etc.). 

The  EU  already  has  sound  experience  of  coordination  in  the  field  of  communicable 
diseases,  which  are  governed  by  comprehensive  EU  legislation  and  which  has  proved 
essential  in  handling  serious  outbreaks  in  Europe72.  This  health  security  initiative  will 
build on these positive experiences, existing systems and lessons learnt to ensure that the 
citizens have equal protection from all health hazards. 

The present initiative will improve coordination at all levels for addressing serious cross-
border health threats, thus providing added value across the EU. 

The preparedness of the Member States will be strengthened by establishing common procedures 
and  shared  standards,  sharing  of  resources,  and  improving  the  exchange  of  expertise  and 
information. 

Capacities  for  rapid  and  efficient  response  will  be  reinforced  and  effective  containment  and 
mitigation of serious cross-border health threat incidents will be ensured. 

Access to and availability of medical countermeasures will be better balanced between Member 
States. 

Overall  strengthened  co-ordination  at  EU  level  will  lead  to  a  coherent  and  comprehensive 
approach  on  risk  assessment  and  management,  thus  contributing  to  a  decrease  in  the  public 
health burden.  

70 

71 
72 

In  the  aftermath  of  the  9/11  terrorist  attack  in  the  USA,  the  Anthrax  scare  undermined  the 
availability  of  the  antibiotic  ciprofloxacin.  During  the  SARS  event,  tourist  and  transportation 
industries have  been heavily impacted by the restriction of movements on a global level. 
See examples: E. coli STEC O104, Volcano ash, red sludge, SARS 
See further details on EWRS in annex 4 

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Since  not  all  Member  States  have  the  same  level  of  preparedness,  risk  assessment  and  crisis 
management facilities73 there is benefit from the exchange of expertise thereby strengthening the 
solidarity with in the EU. Solidarity between countries can also be enhanced by sharing scarce 
medical resources in a crisis situation such as a pandemic.  

As  health  security  is  a  global  issue,  this  initiative  will  provide  EU  Member  States  with  a 
coordination  opportunity  as  regards  the  implementation  of  the  IHR,  where  relations  are 
established only between individual states and the World Health Organization. 

5.2.3.  Principle of proportionality and choice of instrument 

The  scope  of  action  is  limited  to  those  aspects  that  Member  States  cannot  achieve 
satisfactorily on their own, and where the Union can provide added value. 

The  financial  or  administrative  costs  for  the  Union,  national  governments,  regional  or 
local authorities, economic operators or citizens will depend on the chosen option. 

EU  action  leaves  as  much  scope  as  possible  for  national  decision  making,  while 
achieving  satisfactorily  the  objectives  set  out  for  this  initiative.  EU  action  is  without 
prejudice  to the  decision-making process  in  place at national level and is related to the 
monitoring,  early  warning  and  combating  of  serious  cross-border  threats  to  health.  The 
aim  of  EU  action  is  to  better  coordinate  such  measures.  It  fully  respects  the 
responsibilities  of  the  Member  States  to  define  their  health  policy  and  for  the 
organisation and delivery of health services and medical care. 

As such, the stakeholder consultation reflected strong support for EU intervention at this 
level. In addition, an assessment has recently been carried out to ensure that the measures 
proposed  in  this  initiative  will  serve  to  complement  existing  EU  measures  already  in 
place.74 

The choice of the appropriate EU instrument is guided by the need to satisfactorily fulfil 
the  Treaty  obligation  of  protecting  citizens  against  health  threats  and  thus  achieve  the 
objectives of the initiative. In addition, the EU action excludes any harmonisation of the 
laws and regulations of Member States. 

The  reason  for  choosing  a  legislative  instrument  according  to  the  ordinary  legislative 
procedure is to achieve a consistent, coherent and comprehensive long term solution for 
improving health security related to all cross border health threats and to reproduce the 
positive  experience  gained  using  Decision  2119/98  for  communicable  diseases.  Only  a 
legal solution would also guarantee the commitment of all Member States to prepare for 
and respond to health threats in an equal manner. In addition, a legislative instrument is 
needed  in  order  to  provide  EU  level  coordination  for  setting  up  a  joint  procurement  of 
medical countermeasures. 

73 

74 

http://ecdc.europa.eu/en/publications/Publications/0701_TER_Pandemic_Influenza_ 
Preparedness.pdf 
See appendix 3: structures for preparedness and response to cross-border health threats  

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6.  POLICY OBJECTIVES 

6.1. 

General objectives 

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

6.2. 

Specific objectives 

The specific objective of this initiative is to reinforce  the response  to all serious cross-
border  threats  to  health75  based  on  a  comprehensive  and  coherent  approach  to 
preparedness  and  response  planning,  risks  monitoring  and  assessment,  and  risk 
management including risk communication. 

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 
among  Member  States.  This 
to  medical 
countermeasures (e.g. pandemic influenza vaccines). 

improving  equitable  access 

includes 

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

In the area of risk management the specific objective is to create the necessary conditions 
to strengthen and enhance coordination among Member States, international bodies and 
the  Commission  in  order  to  ensure  a  coherent  and  consistent  policy  approach  to 
effectively manage responses to serious cross-border health threats across the EU. 

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. 

6.3. 

Operational objectives76 

In the area of preparedness and response planning the operational objectives are: 

– 

75 
76 

to  develop  and  update  comparable  and  coherent  generic  preparedness  and 
response  planning  and  planning  for  all  threats  at  EU  level,  in  particular  for 
pandemic  influenza.  This  should  ensure  that  critical  sectors  of  society  are  also 

other than those associated with radio nuclear events 
Objectives  should  be  specific,  measurable,  achievable,  realistic  and  timed  (SMART);  the 
operational  objectives  listed  are  specific  and  measurable  in  numbers  of  preparedness  plans, 
agreements etc. They are also realistic to achieve – this has been demonstrated by the framework 
on communicable  diseases  where  events  arise  more  frequently  than  in  the  area  of health  threats 
caused  by  chemical,  biological  or  environmental  events.  Related  to  the  timeframe  for 
implementation the objectives should be achieved three years after adoption of the proposal.  

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29 

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prepared to cope with such health risks and that structures and mechanisms are 
in  place  to  enhance  the  interoperability  and  coherence  of  policies  at  EU  and 
national level; 

– 

– 

to develop and agree shared standards and tailor-made EU criteria for notifying 
threats in order to ensure stronger, continued and resilient operation of the health 
sector  for  the  European  Union,  based  on  the  requirements  laid  down  by  the 
International Health Regulations77.  

to create an instrument to strengthen the Member States' purchasing power and 
to  improve  equitable  access  to  medical  countermeasures,  e.g.  via  a  joint 
procurement mechanism in which Member States can participate on a voluntary 
basis. 

In the area of risk monitoring and risk assessment the operational objectives are: 

– 

– 

– 

to  strengthen,  better  interlink  and  ensure  the  sustainability  of  existing 
monitoring and notification mechanisms and structures; 

to  strengthen  and  create  capacities  for  robust,  reliable,  and  rapidly  available 
public health risk assessment; 

to provide mechanisms for reinforced coordination among existing structures for 
threats arising in policy areas other than for communicable diseases which have 
serious cross-border consequences for health; 

In the area of risk management and crisis communication the operational objectives 
are: 

– 

– 

– 

to  strengthen  the  capacities  and  processes  for  and  establish  a  sustainable 
structure for coordinating the public health response at EU level for any cross-
border public health crisis; 

to  clearly  define  the  scope  of  the  activities  of  this  structure/body  and  give  it  a 
strong  mandate  for  EU  risk  management,  plus  a  strong  commitment  from 
Member States; 

to strengthen measures related to communication on health threats, and provide 
for rapid exchange and agreement on communication messages and strategies; 

7.  POLICY OPTIONS

78 

In order to cover all aspects of crisis management in a coherent framework, each of the 
options  presented  includes  solutions  for  preparedness  and  response  planning,  risk 
monitoring, assessment and management.  

The  actions  identified  in  each  option  vary  according  to  the  level  of  implementation  of 
preparedness  planning  and  core  capacity  requirements  and  the  level  of  obligation  for 
implementation  by  the  Member  States,  the  informal  or  formal  nature  of  the  expertise 

77 
78 

See information as regards the International Health Regulations (IHR) in annex 5. 
An overview of the actions proposed under the three options can be found in annex 13. 

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provided  for  risk  assessment,  and  the  power  conferred  on  the  EU  with  regard  to  risk 
management: 

• 

• 

• 

Option 1 (the status quo) envisages no additional action and corresponds 
to the baseline scenario. 

Option  2  comprises  additional  action  based  on  soft  instruments,  in 
particular.  Council  recommendations  to  ensure  the  involvement  of  the 
Member  States  and  closer  cooperation  between  existing  structures  and 
systems. There are no legally binding measures under this option. 

Option 3 proposes a legal framework that lays down binding measures for 
Member  States  as  regards  preparedness  planning,  provides  a  legal  basis 
for  voluntary  measures  and  implements  a  robust  structure  for  crisis 
management.  This  option  seeks  to  amend  the  existing  Council  and 
European Parliament Decision on communicable diseases and extend it to 
serious  cross  border  health  threats  caused  by  biological  (other  than 
communicable  diseases),  chemical  or  environmental  events.  The 
provisions  for  risk  assessment  under  this  option  are  not  included  in  the 
legal framework as they also build on closer cooperation between existing 
structures  and  systems  and  are  intended  to  cover  existing  gaps  in  these 
areas. 

7.1. 

Option  1:  Status  quo  /  baseline  scenario:  Maintain  the  current  level  of 
activities  

Preparedness and response planning 

On  preparedness  the  Commission  would  continue  the  technical  level  work  with  the 
Member  States  described  where  appropriate 
in  staff  working  documents  or 
communications:  updating  and  facilitating  the  implementation  of  existing  guidance  as 
regards  generic  and  pandemic  preparedness.  Surveys  and  development  of  indicators 
would be supported. Organising of exercises and training where public health crises are 
simulated, and exchange of best practice would continue.79 

To  improve  equitable  access  to  medical  countermeasures,  the  Commission  would 
continue to support Member States' cooperation, e.g. in helping Member States prepare 
their national tender specifications for vaccine procurement. 

The  Commission  would  also  continue  to  promote  improved  production  capacity,  for 
instance  through  improved  vaccination  coverage  for  seasonal  influenza,  which  could 
influence capacity building for the production of pandemic influenza vaccine. 

Risk monitoring and assessment 

The  EU  would  continue  to  work  with  the  existing  voluntary  based  notification  and 
monitoring  mechanisms  and  structures  without  strengthening  coordination  among  the 
policy  areas  concerned.  Communicable  diseases  would  remain  under  the  existing  legal 
framework.  Risk  assessment  related  to  serious  cross-border  health  threats  arising  from 
threats  caused  by  biological  (other  than  communicable  diseases  as  these  are  covered 

79 

Using as presently funds from the EU Health Programme 

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already by a legal framework), chemical, ) and environmental events would be delivered 
on the basis of ad hoc support networks as the ECDC has no mandate for risk assessment 
for threats other than communicable diseases. 

Risk management and crises communication 

The  mandate  of  the  Health  Security  Committee  under  the  Council  conclusions  of  22 
February 200780, as prolonged by the Council conclusions of 13 September 2010, would 
be  maintained  and  the  Council  would  be  the  EU  institution  which  would  prolong  its 
mandate,  as  in  the  current  situation.  The  HSC  would  remain  an  informal  body  and  the 
commitment of Member States would be maintained at the current level. 

The informal HSC communicator's network would continue to facilitate the exchange of 
information during a crisis and continue to share information on an ad-hoc and voluntary 
basis. 

7.2. 

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 – no legally binding measures 

The  essential  change  in  comparison  to  option  1  consists  in  a.  improved  and  better 
coordinated preparedness and response planning based on common criteria between the 
Member  States  and  in  relation  to  IHR;  b.  improved,  more  sustainable  and  structured 
cooperation  between  existing  systems  for  health  emergencies  caused  by  biological, 
chemical,  or  environmental  events;  c.  clarification  of  the  roles  of  existing  management 
bodies, in particular the EWRS network81 and the HSC82. Action under this option would 
mainly be built on soft instruments such as guidance, Commission Communications and 
Council  Recommendations;  it  would  rely  on  improved  cooperation  between  existing 
systems and additional commitment of Member States by strongly using the instrument 
of Council Recommendations to address necessary changes; however, the actions under 
this option would still require  cooperation  of  Member  States on a voluntary basis even 
with  the  formal  support  of  the  Council;  they  would  not  be  legally  binding  for  Member 
States. 

Preparedness and response planning 

The Commission would propose to the Member States a shared approach on generic and 
specific preparedness planning, including for pandemic influenza. This approach would 
be non-binding and voluntary for the Member States. 

This would include identification of EU core capacity standards related to surveillance, 
notification,  verification,  response  and  collaboration  activities  building  on  and 
strengthening requirements under IHR. 

The Commission would provide guidance on improved  cross-sectoral preparedness and 
interoperability  and  continue  to  encourage  exchange  of  best  practice  through  seminars 
and workshops and provide incentive measures via the Health programme. 

80 
81 
82 

http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf 
See details in annex 4 
See details in annex 2 

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In order to improve equitable access to medical countermeasures the Commission could 
continue,  as  described  in  option  1,  to  take  incentive  measures  relating  to  capacity 
building  for  vaccine  production  and  to  play  a  supporting  role  in  Member  States 
cooperation,  e.g.  in  the  preparation  of  their  national  tender  specifications.  However,  it 
should  be  noted  that  this  option  would  not  improve  the  conditions  for  procurement  of 
medical  countermeasures,  other  than  the  Commission  supporting  Member  States  in 
preparing their national tenders. 

In addition, as part of option 2, the following incentives could be envisaged: 

1.  stimulate  via  the  Innovative  Medicines  Initiative83  the  development  of 
new production techniques to improve the industry's production capacity 
for medical countermeasures; 

2.  establish,  complementary  to  national  stockpiles,  a  real84  or  virtual85  EU 
stockpile of medical countermeasures to cover urgent / unforeseen needs 
that exceed the capacity of national stockpiles. Examples of how such a 
complementary EU stockpile could look like and what it would cost are 
given in annex 17. 

3.  strengthen  national  procurement  procedures  by  improving  the  exchange 
of  information  on  contractual  conditions  and  best  practices  via  the 
confidential platform CIRCA BC. 

Risk monitoring and, assessment86 

As regards notification of threats caused by chemical, biological or environmental events 
a Council  Recommendation to Member States  would be issued to mutually  notify  each 
other and the Commission of threats by means of tailor-made criteria as required by the 
integrated nature of the EU. However, there would be no obligations for Member States 
to do so. 

Risk  monitoring  and  risk  assessment  for  other  serious  cross-border  threats  to  health 
would rely on improved coordination by putting in place informal arrangements among 
existing EU structures, such as the EU agencies or informal networks currently in place 
as  the  ECDC  has  no  mandate  to  carry  out  risk  assessment  for  other  threats  than 
communicable  diseases.  This  cooperation  would  be  carried  out  using  existing  financial 
and administrative resources. 

Risk management and crisis communication 

83 
84 

85 

86 

http://www.imi.europa.eu/ 
For  medical  countermeasures  that  are  available  before  a  threat  arises,  e.g.  ciprofloxacin  against 
anthrax. 
For  medical  countermeasures  that  are  not  available  before  a  threat  arises,  e.g.  vaccines  against 
pandemic  influenza.  A  virtual  stockpile  is  a  guaranteed  number  of  doses  of  the  pharmaceutical 
which will be delivered when it becomes available. 
The  required  simplification  and  updating  the  framework  for  communicable  diseases  regarding 
epidemiological surveillance in order to take account of the establishment of the ECDC is not part 
of the impact assessment as changes can be considered as purely technical 

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The Health Security Committee87 would be abolished in its current form and formalised 
as  a  Commission-led  expert  group.  Its  mandate  would  be  reviewed  and  limited  to 
coordination of preparedness, notification of measures implemented at national level and 
coordination  of  response  for  serious  cross-border  threats  to  health  caused  by  biological 
(other  than  communicable  diseases88),  chemical  or  environmental  events  or  those  of 
unknown origin. No binding requirements would be laid down for Member States under 
this option. 

As  regards  communication  aspects,  Member  States,  in  liaison  with  the  Commission, 
would  start  developing  shared  communication  approaches  and  guidelines,  e.g.  sharing 
best practice in dealings with the media. 

7.3. 

Option  3:  Establish  a  common  EU  legal  framework  covering  all  serious 
cross-border threats to health by extending existing legislation - improved 
cooperation and legally binding measures  

EU  competences  on  communicable  diseases  as  laid  down  in  Decision  2119/98/EC89 
would  be  extended  to  cover  all  other  serious  cross-border  threats  to  health90.  Legal 
provisions would take account of specific aspects of these other threats and the measures 
related  to  preparedness,  notification  and  risk  management  would  be  legally  binding  on 
Member States. A legal base for joint procurement of medical countermeasures would be 
established and new measures provided for in the Lisbon Treaty to combat serious cross 
border threats to health would be implemented. 

The proposals for risk assessment at EU level for other threats are not part of the legal 
text  as  they  can  be  implemented  by  building  on  improved  and  sustainable  cooperation. 
Additional  financial  implications  are  proposed  to  ensure  sustainability  of  existing 
networks in the risk assessment process, however no new agency is proposed.  

This option builds on the Commission agenda Europe 2020, the EU Health strategy and 
the  EU  security  framework.  It  also  sets  binding  standards  for  cooperation  between  the 
International Health Regulations and the EU.91 

Preparedness and response planning 

Under this option the Member States would have the obligation to put in place an agreed 
approach  on  generic  and  specific  preparedness  planning,  including  for  pandemic 
influenza and would report regularly on its implementation. As regards preparedness for 
multidisciplinary implications of a crisis, Member States would consent to cooperate in 
the  cross-sectoral  preparedness  and  response  planning  through  the  establishment  of 
guidelines and indicators, the organisation of exchange of best practices and preparation 
of  periodic  monitoring  and  evaluation.  Building  on  ongoing  work  to  ensure  business 
continuity in critical sectors in Europe, inter-sectoral coordination would be enhanced to 
ensure  that  other  critical  sectors  (e.g.  transport,  energy,  ICT)  apart  from  public  health 

87 
88 

89 
90 
91 

http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf 
The  issue  of  preparedness  and  coordination  measures  regarding  pandemic  influenza  would  fall 
under the structures established by Decision n° 2119/98/EC. 
Currently limited to communicable diseases 
Apart from threats caused by radiological events 
A  detailed  description  of  the  tasks  and  obligations  of  the  Member  States  and  the  Commission 
under this option is provided in annex 15.  

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have  detailed  and  comprehensive  preparedness  plans  in  place.  The  focus  would  be  for 
Member States to ensure business continuity in these sectors to improve the sustainable 
functioning of these sectors in the event of a crisis. Member States would also agree to 
implement  in  a  complementary  way  requirements  on  shared  common  minimum  core 
capacity  standards  for  preparedness  and  response  (e.g.  adequate  human  resources, 
designation of responsible entity). Furthermore, Member States would agree to use tailor-
made  criteria  for  notification  at  EU  level  of  serious  cross-border  threats  to  health, 
including events which may constitute public health emergencies of international concern 
under IHR. 

This  option  provides  a  legal  basis  for  a  joint  action  for  the  purchasing  of  medical 
countermeasures, such as pandemic influenza vaccines. This would create an opportunity 
to  set  up  and  manage  an  EU  mechanism  for  joint  procurement  of  medical 
countermeasures  in  which  Contracting  Parties92  could  participate,  on  a  voluntary  basis. 
The  procedural  and  organisational  arrangements  of  the  joint  procurement  mechanism 
would  not  be  part  of  the  legal  act  but  would  be  laid  down  in  a  'Joint  Procurement 
Agreement'  signed  by  all  participating  Contracting  Parties.  The  joint  procurement 
mechanism will give full flexibility to the Contracting Parties to procure what and how 
much  they  want.  The  purchasing  power  of  the  participating  Contracting  Parties  will  be 
strengthened  by  pooling  similar  procurement  requirements.  Whereas  the  Commission 
will  coordinate  the  joint  procurement  mechanism,  the  Contracting  Parties  will  be 
responsible for awarding and signing framework contracts93 and for the payment of any 
medical  countermeasures  they  order.  An  illustration  of  how  the  joint  procurement 
mechanism would work is given in annex 18. 

Risk monitoring and assessment 

Mechanisms  and  structures  currently  in  place  for  risk  monitoring  and  assessment  of 
threats  caused  by  chemical,  biological  or  environmental  events  will  be  formalised  and 
strengthened. 

A  coordination  system  will  be  put  in  place  and  the  Member  States  affected  by  a  crisis 
consent to notify at EU level cases of cross-border threats to health caused by chemical, 
biological  and  environmental  events  –  as  they  have  already  done  in  the  past  –  notify 
threats arising from communicable diseases. 

In  parallel,  Member  States  would  be  obliged  to  notify  the  EU  level  in  all  cases  where 
notifications are made to WHO under the International Health Regulations. 

Based on experience with data protection in the area of communicable diseases provision 
will  be  taken  that  the  existing  alert  systems  will  enable  secure  information  sharing  in 
respect  of  data  protection  rules,  for  example  to  trace  persons  exposed  to  a  chemical 
contaminant. 

Where  the  ECDC or  another EU  Agency, Member States  or  the Commission identifies 
serious cross-border threats to health, on the basis of either notification systems or risk 

92 

93 

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). 
A framework contract guarantees a certain number of doses of a medical countermeasure that will 
be made available when the signatory Contracting Parties wish to order. However, a framework 
contract does not put any obligation on Contracting Parties to order the medical countermeasures. 

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monitoring,  a  risk  assessment  may  be  performed  using  existing  structures  at  EU  or 
national levels in conjunction with the Commission. The Commission would be tasked to 
provide for a coherent and comprehensive public health risk assessment at EU level. 

Potential  gaps  in  risk  assessments  for  specific  threats  would  be  covered  by  putting  in 
place  additional  capacities  for  scientific  expertise.  Based  on  financial  means  of  EUR 
500,000 per  year94 provided by the Health programme, a framework contract would be 
established  to  guarantee  that  additional  expertise  can  be  requested  when  needed.  This 
contract would help to establish permanent networks of national correspondents between 
health  authorities  and  agencies  competent  in  assessing  specific  health  threats,  for 
example  related  to  toxic  chemicals,  maritime  or  air  transport.  Through  these  networks, 
assessment of the cross border dimension of specific health threats would be provided to 
the  EU  level  where  these  assessments  would  be  fed  into  the  early  warning  and  crisis 
prevention  and  management  structures.  In  addition,  these  investments  contribute  to 
capacity building in terms of improved training and methodology.  

Relevant international agencies (e.g. WHO) would be associated to these networks. 

Risk management and crisis communication 

As regards risk management, EU action would consist in ensuring that the public health 
response  by  Member  States  to  a  serious  cross-border  health  threat  is  presented  on  a 
coherent and coordinated basis. 

This  involves  defining  the  characteristics  of threats  to  be  addressed  by  the  new  regime 
(communicable diseases, other biological threats, chemical and environmental threats and 
threats of unknown origin). 

On  this  basis,  the  relevant  criteria  for  binding  notification  of  such  threats  would  be 
specified  and  the  conditions  and  rules  would  be  laid  down  in  such  a  way  that  a 
coordinated  and  coherent  public  health  response  can  be  undertaken.  This  option  would 
specify, as is currently the case for communicable diseases, the other types of threats to 
be  covered,  criteria  for  notification  of  events  and  areas  where  measures  could  be 
coordinated at the EU level. It would provide for EU action through advisory activities, 
non  legislative  acts  and  instruments  for  mutual  agreements  or  joint  actions  between 
Member States. 

EU action as described above will – as is the case for communicable diseases - cover the 
following measures as a priority: 

(a) 

(b) 

94 

Advisory  activities  on  preparedness  and  response  planning,  public  health 
response coordination such as on school closure, travel advice, communication 
strategies and coordinated messages, and common strategies on vaccination. On 
this  basis  the  Commission  may,  with  the  support  of  expert  groups,  adopt 
recommendations 
these 
recommendations in a legal text. 

to  Member  States  and  clarify 

the  scope  of 

Non  legislative  acts  (i.e.  delegated  and  implementing  acts)  would  cover  for 
example  guidelines  on  protective  measures  to  be  taken,  particularly  in  an 

Costs estimated based on the costs incurred for a framework contract in the past for setting up a 
pilot project on assessment of health threats other than communicable diseases. 

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36 

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emergency situation; guidelines on information and guides to good practice for 
the public (e.g. hygiene measures). 

(c) 

Voluntary  mutual  agreements  between  concerned  Member  States  based  on 
measures  recommended  by  the  Commission  which  might  be  implemented  at 
national level. 

In addition, a new and voluntary instrument mechanism for joint procurement of medical 
countermeasures, particularly pandemic vaccines, would be established. 

Communication  would  be  greatly 
the  development  of  common 
communication  strategies  and  by  better  integrating  the  Communicators  into  the  crisis 
management process and by closer linking decision makers and risk managers. 

improved  by 

Coordination  of  a  crisis  would  be  organised  with  the  help  of  a  Health  Security 
Committee  composed  of  representatives  of  Member  States  and  chaired  by  the 
Commission  which  provides  also  the  secretariat  to  this  committee.  Thus,  the  current 
work consisting  of  coordination  of  public health response done by the EWRS Network 
and the Health Security Committee, including work on communication, would be merged 
in order to cover all serious cross-border threats to health within a single structure.  

8.  ANALYSIS OF THE IMPACTS 

As described under chapter 3, health emergencies can have huge impacts on the health of 
citizens and society, and can also have significant financial consequences, in addition to 
their impact on the health of citizens.95 

A  summary  of  impacts  is  provided  below.  The  health  impacts  are  described  in  more 
detail in annex 16 where the actions proposed under each option are thoroughly analysed 
as regards their effects and consequences in relation to the objectives. 

In  addition,  annex  19  describes  further  impacts:  in  particular  social  and  economic 
impacts,  financial  implications  and  administrative  burden,  EU  added  value  and  the 
impact of each option at international level. 

None of the identified options will have impacts on the environment or employment that 
can be predicted with any accuracy. 

8.1. 

Option  1:  Status  quo/baseline  scenario  -  maintain  the  current  level  of 
activities  

Public health impact: As the status quo is maintained under this option, there will be no 
impact on conditions for the protection of EU citizens from serious cross-border health 
threats  and  on  the  effectiveness,  efficiency  and  coherence  related  to  the  public  health 
security  structures  and  systems  to  respond  to  such  threats.  As  described  under  the 
baseline scenario and under the problems, this situation would keep in place a status quo 
that could potentially endanger the capacities to ensure the containment and mitigation of 
a cross-border health threat and lead to an increase in mortality and morbidity rates at EU 
level. 

95 

See tables 1 and 2 in annex 6  

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Social impact: This option is not expected to improve communication to the EU citizens 
and  solidarity  between  the  Member  States  in  the  case  of  serious  cross-border  health 
threats, as it does not address the shortfalls identified in these areas.  

Economic  impact:  In  a  status  quo  situation,  critical  sectors  will  not  be  sufficiently 
prepared for the consequences of a serious cross border health event96. This could result 
in diverse and inconsistent responses in the event of a public health crisis and a greater 
risk  of  economic  repercussions  such  as  productivity  losses  and  absenteeism97).  As  a 
consequence, internal market and external trade functions could be disrupted, leading to 
substantial economic losses as illustrated during the recent STEC O104 outbreak98. 

Financial impact: The financial implications under this option will not change. While no 
additional  costs  would  arise  for  Member  States  and  stakeholders,  resources  to  support 
work  on  combating  serious  cross-border  health  threats  will  mainly  be  allocated  by  the 
administrative  budget  of  the  EU  (for  example  for  meetings  etc)  and  the  financial 
resources of the Health Programme  

Administrative burden: Under this option, the necessary administrative resources for both 
the  Commission  and  the  Member  States  will  remain  unchanged.  However,  the 
management  of  these  resources  will  remain  sub-optimal,  as  there  will  continue  to  be 
overlaps between the EWRS network and the Health Security Committee in the field of 
communicable diseases. 

EU added value: The impact and EU added value in coordinating the response to cross-
border health threats will remain unchanged, and collaboration at international level will 
not be improved either. 

8.2. 

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 

Public  health  impact:  The  impact  on  public  health  could  be  improved  as  the  overall 
situation in terms of preparedness for and response to a crisis will be strengthened along 
with the effectiveness, efficiency and coherence of public health security structures and 
systems.  This  would  be  achieved  through  EU-wide  recommendations  supported  by 
Member States. However, these positive impacts would only be potential and would rely 
on  the  commitment  of  the  Member  States  to  agree  on  these  recommendations  and 
implement them. Against this background, this option could more specifically result in an 
increased  coherence  of  overall  preparedness,  improved  coordination  of  existing 
notification tools and strengthened risk assessment capacities, thus stepping up the level 
of capacity to react more rapidly and comprehensively to a cross-border health threat. In 
addition, the risk management structures supporting a coordinated response at EU level 
would be sustainable if they had clearer mandates, thereby improving the effectiveness of 
heath  crisis  management.  Crisis  communication  would  be  enhanced  and  benefit  from  a 
more coherent approach and capacities when managing a crisis. However the quality and 

96 
97 
98 

See annex 8 for further details 
http://www.who.int/countries/eth/areas/cds/en/index.html 
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/938&format= 
HTML&aged=0&language=EN&guiLanguage=en and 
http://pl2011.eu/sites/default/files/dokumenty/user43/sn03124_en11_comments.pdf 

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coordination of the response to a threat would only be as strong as the weakest link of the 
whole structure and depend on the preparedness of Member States to implement. 

The  impact  of  this  option  on  access  to  medical  countermeasures  is  expected  to  be  an 
improvement  over  Option  1.  Indeed,  incentive  measures  via  the  Innovative  Medicines 
Initiative  could  support  research  into  the development  of  new  production  techniques  to 
improve production capacity for medical countermeasures such as has been achieved in 
the  United  States  by  the  Biomedical  Advanced  Research  and  Development  Authority 
(BARDA)  initiative99. An improved  production  capacity means that a larger proportion 
of  the  population  can  be  protected  or  treated  within  a  short  time  frame  when  a  threat 
emerges. 

In addition, this option foresees the setting up of a complementary EU stockpile which 
could alleviate urgent/unforeseen needs exceeding the capacity of national stockpiles. 

Social  impact:  Provided  that  the  Member  States  implement  the  agreed  guidance  and 
recommendations,  improved  risk  management  and,  in  particular,  better  coordination  of 
risk communication is likely to have a beneficial effect on citizens, as messages issued to 
the public would be more consistent within the EU and better avoid contradictions. Thus, 
the confidence in the ability of public health authorities to manage a health crisis would 
increase. In addition, inter-sectoral cooperation to improve public health protection will 
be  strengthened.  As  regards  equitable  access  to  medical  countermeasures,  this  option 
would enable expertise expertise to be pooled among the Member States solidarity and 
cooperation  to  be  improved  in  terms  of  preparation  of  the  procurement  procedures,  as 
smaller  Member  States  would  benefit  from  the  skills  and  lessons  learnt  from  other 
countries.  A  complementary  EU  stockpile  of  medical  countermeasures  that  can  be 
deployed  to  help  Member  States  with  urgent/unforeseen  needs  is  expected  to  improve 
solidarity,  and  –  to  a  limited  degree  –  improve  equitable  access  to  medical 
countermeasures.  

Economic  impact:  Under  option  2  a  more  rapid  risk  assessment  and  management  of  a 
given  threat  would  reduce  the  economic  consequences  related  to  a  health  event.  For 
example,  the  disruption  of  the  internal  market  and  external  trade  functions  might  be 
minimised  and  economic  losses  reduced.  However,  these  potential  impacts  would  rely 
essentially on the Member States' commitment to agree on and implement developed EU 
"soft law" guidance such as recommendations. In the field of medical countermeasures, 
option  2  could  positively  impact  on  innovation  and  R&D  efforts  related  to  new 
production  techniques  to  improve  the  industry's  production  capacity  for  medical 
countermeasures,  as  further  support  actions  could  be  envisaged  in  particular  under 
existing instruments (e.g. Innovative Medicines Initiative100). 

Financial  implications:  The  main  stakeholders  under  this  option  are  the  Member  States 
and  the  Commission.  No  additional  costs  either  for  Member  States  or  for  the 
Commission are expected under this option.  

Regarding  research  and  development  of  medical  countermeasures,  existing  financial 
mechanisms will be used as much as possible (Innovative Medicines Initiative).  

99 
100 

http://www.phe.gov/preparedness/pages/default.aspx 
http://www.imi.europa.eu/ 

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39 

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As  regards  access  to  medical  countermeasures,  option  2  remains  at  the  level  of 
cooperation between individual procurements with no additional significant costs for the 
Member  States.  However,  there  would  be  no  financial  gain  either  as  the  purchasing 
power and ability to obtain better financial and contractual conditions will remain much 
weaker compared to the option of a full joint procurement, as proposed under option 3. 

Costs  related  to  the  potential  setting  up  of  complementary  EU  stockpiles  of  medical 
countermeasures  are  illustrated  in  annex  17.  Because  a  complementary  EU  stockpile 
would  mean  that  Member  States  still  needed  to  procure  medical  countermeasures  for 
their  national  stockpiles  individually,  the  weak  purchasing  power  identified  as  a  major 
weakness during the influenza H1N1 (2009) pandemic would not be addressed. In 2006, 
the  Commission  already  proposed  the  setting  up  of  a  complementary  EU  stockpile  of 
antivirals  for  use  in  the  event  of  an  influenza  pandemic.  However,  this  initiative  was 
withdrawn  as  the  Health  Council  did  not  reach  a  consensus  on  the  funding  source  for 
such a stockpile101.  Alternatives  such as the  Swiss legislation obliging the producers to 
create  a  stockpile  of  essential  goods  (incl.  antivirals)102  at  marginal  cost  to  the 
Government could be regarded as a way to minimise costs. However, this does not seem 
feasible in the EU since Article 168 of the Treaty does not provide a legal basis to legally 
oblige manufacturers to hold or supply medical countermeasures or raw materials for the 
manufacture of countermeasures. 

Administrative  burden:  Under  this  option,  the  administrative  burden  for  the  Member 
States  and  the  Commission  would  be  reduced,  as  the  mandates  of  the  two  relevant 
committees (EWRS Network Committee and the newly created expert committee based 
on the former Health Security Committee) would be clearly defined, thereby minimising 
the risks of overlap. However, these gains would be limited as there would still be two 
separate entities.  

As  regards  access  to  medical  countermeasures, the  administrative  burden  could  also  be 
reduced  for  Member  States  as  cooperation  between  individual  national  procurement 
procedures  would  allow  the  pooling  of  national  expertise103.  However,  this  positive 
impact would be limited to the preparation of the technical specifications, as the rest of 
the procurement processes would still be implemented individually at national level.  

If  stockpiles  at  European  level  would  be  created  additional  administrative  capacities 
would  be  needed  in  particular  during  the  setting  up  phase  and  devising  and  testing 
mechanisms for delivery and distribution in a crisis.  

EU  added  value:  The  EU  added  value  would  be  increased  as  the  coordination  of 
preparedness and response to cross-border health threats could be enhanced at EU level. 

Impact at international level: Under this option, the impact related to international level 
would  be  stronger,  as  attempts  would  be  made to link  International Health  Regulations 
more effectively to reporting of threats at EU level. 

101 

102 
103 

http://europa.eu/rapid/pressReleasesAction.do?reference=IP/06/732&format=PDF& 
aged=1&language=EN&guiLanguage=fr 
http://www.bwl.admin.ch/themen/01009/01025/index.html?lang=en 
In the case of Austria, savings involved in a joint procurement amounted to 60% of administrative 
costs: http://ec.europa.eu/environment/gpp/pdf/toolkit/module1_factsheet_joint_procurement.pdf  

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8.3. 

Option  3:  Establish  a  common  EU  legal  framework  covering  all  serious 
cross-border threats to health by extending existing legislation - improved 
cooperation and legally binding measures 

Public  health  impact:  Under  this  option,  the  protection  of  EU  citizens  against  serious 
cross-border health threats and the effectiveness of public health security structures and 
systems  at  EU  level  would  be  considerably  improved.  It  would  indeed  allow  coherent 
preparedness  planning  based  on  shared  and  common  mandatory  standards  and  a  better 
coordinated and balanced response to all types of cross-border health threats. This would 
be supported by establishing a single structure addressing the management of such events 
and  empowering  the  Commission  to  coordinate  with  the  Member  States  the  advisory 
activities,  non  legislative  acts,  recommendations,  and  mutual  agreements  to  be 
implemented at national level.  

In  addition,  the  notification  of  threats  would  be  ensured  due  to  enhanced  cooperation 
with the existing alert and systems and structures, as well as EU tailor-made criteria for 
notification of health threats. Along with enhanced and sustainable cooperation for risk 
assessment with existing networks of national experts, relevant Commission services, EU 
agencies and international organisations, this option would result in a more coherent and 
comprehensive  approach  to  identification,  notification  and  assessment  of  serious  cross-
border health threats. 

improve  equitable  access  by  Member  States 

Finally,  by  setting  up  a  legal  basis  allowing  voluntary  joint  procurement,  this  option 
to  medical 
would  considerably 
countermeasures, thereby ensuring a higher level of protection of the EU citizens across 
the  Union.  The  positive  public  health  impacts  related  to  the  development  of  such  a 
mechanism were further demonstrated by previous similar initiatives developed in other 
countries and regions104. 

Furthermore, inter-sectoral cooperation would be improved in the event of cross-border 
health threats, also contributing to better public health protection. Critical sectors would 
be  identified  and  prepared,  and  procedures  for  improved  inter-sectoral  coordination 
would be established based on the 'whole of society' approach of the WHO, in particular 
for pandemic preparedness.  

Social impact: Along with the impacts related to improve coordination of communication 
already  identified  for  option  2,  increased  cooperation  would  facilitate  a  better 
understanding of citizens' needs and worries, better targeted messages, and a coordinated 
approach on access to medical countermeasures would result in a more favourable public 
opinion  and  would  raise  confidence  in  the  measures  undertaken  by  public  health 
authorities. In the context of an influenza pandemic, a joint procurement mechanism for 
medical  countermeasures  would  result  in  a  higher  level  of  protection  for  vulnerable 
groups due to better synchronised and more effective vaccination campaigns. In addition, 
such a mechanism would promote solidarity between the Member States by ensuring that 
participating countries have a minimum level of access to medical countermeasures.  

104 

One  Year  assessment  of  joint  procurement  of  pharmaceuticals  in  the  public  health  sector  in 
Jordan, http://www.sciencedirect.com/science/article/pii/S0149291809001672 

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Economic impact: Under option 3 the positive impacts already described under option 2 
would be expected. However, they might be stronger, given that the measures would be 
based on binding agreements. 

In addition, in the field of innovation, development and research the setting up of a joint 
procurement  mechanism  on  medical  countermeasures  would  strengthen  the  supply  of 
medical  products  and  encourage  existing  and  potential  new  suppliers  to  develop  new 
products based on long term contracts agreed with the public health sector.105 

Financial  impact:  The  main  stakeholders  under  this  option  are  the  Member  States,  the 
Commission and private companies in the health sector and in other sectors.  

A. Costs for preparedness, assessment and management of the Health Security Initiative 

For  the  Member  States  notification  costs  are  not  expected  to  increase  significantly  as 
Member  States  are  already  obliged  to  report  either  at  the  EU  level  on  communicable 
diseases  or  to  the  WHO  under  the  International  Health  Regulations  on  "all  hazards". 
Reviewing processes and procedures would need to be envisaged, but the costs for this 
can be considered marginal.  

The new activity of obliging the Member States to set up generic preparedness planning 
would  be  based  on  the  previous  work  and  existing  mechanisms.  Administrative  costs 
would not significantly increase.  

The  costs  for  coordination  meetings  may  be  at  the  same  level  or  even  less  given  the 
comprehensive mandate of the health group for all serious cross border threats to health. 

As regards the newly established reporting and monitoring procedures to implement the 
improved  health  security  framework  the  following  costs  per  Member  State  can  be 
envisaged:  0.3  –  0.5  Full  Time  Equivalent  for  a  national  expert  over  a  period  of  2-3 
months to address reporting. 

For  the  Commission:  as  regards  preparedness  additional  costs  could  be  expected,  in 
particular  in  relation  to  human  resources  and  the  provision  of  technical  equipment; 
however, it is planned to cover these staff capacities/overhead costs by reorganising the 
human resources available and by building on existing platforms. Hence, the additional 
costs are considered marginal. 

If  a  more  sustainable  solution  on  risk  assessment  would  be  set  up  on  a  formal  basis 
building  on  existing  systems  and  better  linking  them  this  would  require  additional 
financial  resources  from  the  EU  health  programme  in  the  region  of  EUR  500,000  per 
year  to  set  up  framework  contracts  in  order  cover  existing  gaps  by  making  expertise 
available  where  needed.  The  calculation  is  based  on  experience  with  a  similar  pilot 
project  for  assessment  of  health  threats  other  than  communicable  diseases  in  the  past. 
The  intended  framework  contract  is  planned  to  allow  for  such  gaps  to  be  filled  by 
establishing  permanent  networks  of  national  correspondents  between  health  authorities 
and agencies competent in assessing specific health threats, for example related to toxic 
chemicals (94 poison centres in the EU). 

105 

EC Green Public Procurement Training Toolkit – Joint Procurement Fact Sheet, p.3 
http://ec.europa.eu/environment/gpp/pdf/toolkit/module1_factsheet_joint_procurement.pdf 

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Cross  border  threats  caused  by  chemical,  biological  and  environmental  events  do  not 
occur as often as communicable diseases. Based on IHR notifications we can expect on 
average 5-6 such events per year106. Under EU tailor made criteria for these incidents the 
threats  notified  -  based  on  experience  with  alerts  for  communicable  diseases  -  could 
amount  to  20  -25  per  year.  The  frequency  of  such  events  is  likely  to  increase  due  to 
increases  in  global  travel  and  trade,  climate  change  and  latent  risk  of  criminal  and 
terrorist attacks. 

Therefore,  the  financial  burden  of  the  measures  needed  in  order  to  prepare  for  serious 
cross-border threats to health is justified and proportionate compared to the damage and 
impact on society which can be significant in scale and can by far exceed the financial 
input. The additional costs would also be justified as scientific expertise would not only 
be  provided  for  a  given  threat  assessment,  a  sustainable  network  would  also  allow  for 
capacity  building  and  training  in  the  area  of  chemical,  biological  and  environmental 
threats. 

It is not expected that costs for coordination of improved risk management would rise as 
a similar meetings cycle for the new health committee as in the present for the existing 
EWRS  and  Health  Security  Committee  will  be  maintained.  Administrative  budget  for 
these meetings is available.  

As  regards  the  new  reporting  requirements  0.3  Full  Time  Equivalent  for  an 
Administrator/Policy Officer for the reporting process will be needed. EUR 5,000-20,000 
for external expertise to support the development of a questionnaire and the analysis of 
the  replies  by  the  Member  States  will  be  needed  to  implement  the  yearly  reporting 
schemes. EUR 300,000-700,000 every five years for external and independent evaluation 
would  be  needed.  The  amount  depends  of  the  scope  and  details  of  the  tender 
specifications for the evaluation. 

B. Access to medical countermeasures 

With  regard  to  access  to  medical  countermeasures,  option  3  would  aim  to  better 
coordinate  the  procurement  of  medical  countermeasures  already  currently  being 
conducted  nationally.  Thus  there  would  be  no  new  financial  commitments  for  the 
Member  States.  On  the  contrary,  evidence  from  other  initiatives  indicates  that  such  a 
mechanism would lead to stronger purchasing power, economies of scale, more attractive 
offers  from  suppliers  and  improved  contract  conditions  for  the  Member  States107  (for 
further details see annex 17). In addition, a joint procurement mechanism would result in 
lower administrative costs108. Although financial implications can be expected during the 
setting up of the proposed mechanism and the occurrence of cross-border health threats 
(additional  staff  and  administrative  costs)  for  the  entity  in  charge  of  operating  the 
contract, these costs would be reduced during the running of the contract prior to a cross-
border health threat.  

Other Stakeholders/private companies  

106 
107 

108 

See information in annex 11  
http://www.rho.org/files/IAVI_vaccine_procurement_pricing.pdf; Local Authority Procurement: a 
research report, UK Office of the Deputy Prime Minister, 
http://www.communities.gov.uk/archived/publications/localgovernment/localauthorityprocurement; One 
Year assessment of joint procurement of pharmaceuticals in the public health sector in Jordan,: 
http://www.sciencedirect.com/science/article/pii/S0149291809001672 
As shown by Austria, where a similar joint procurement initiative - the Eco-procurement Service 
of Vorarlberg - has for instance achieved savings up to 60% in administrative costs 

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It is not expected that private companies would have any obligations for alert reporting as 
such.  As  regards  improved  preparedness  and  business  continuity  in  private  sector 
companies it is worth noting that in particular large companies have already engaged in 
putting in place business continuity planning at their own initiative based on the rationale 
that  investing  in  business  continuity  is  highly  cost  effective  albeit  by  nature  never  cost 
neutral  or  possible  without  any  administrative  input.  There  is  no  intention  to  impose 
measures with financial implications. The intention is to encourage the exchange of best 
practice illustrating the overall benefit of improved business continuity planning thereby 
encouraging companies to invest in business continuity planning.  

Administrative burden: As regards preparedness and response planning there would be a 
certain administrative burden for Member States to develop and implement core capacity 
standards in line with the International Health Regulations; however, the additional work 
needed to define in addition specific EU criteria can be considered as marginal.  

As regards notification and risk assessment, Member States are already obliged under EU 
legislation to notify health threats including communicable diseases and other incidents 
threats at EU level, and as well to the WHO under the International Health Regulations. 
There will be a certain amount on administrative burden to establish links between these 
systems  and  review  existing  reporting  mechanisms;  however,  this  burden  will  decrease 
once the connections and links are made. Thus established efficiency will be gained and 
coherence  and  cooperation  between  reporting  tools  will  have  positive  effects  on 
administrative procedures, they will be streamlined and double work will be avoided.  

Costs induced for reporting are supposed to add administrative burden, however will be 
counterbalanced  by  improved  reporting  and  information  and  hence  better  preparedness 
for future crises. 

Under  this  option  governance  in  public  health  risk  management  would  be  significantly 
improved as only one expert committee would need to be operated.  

As regards the newly established reporting and monitoring procedures to implement the 
improved health security framework Member State would need to provide 0.3 – 0.5 Full 
Time Equivalent for a national expert over a period of 2-3 months to address reporting. 
As Member States have also reporting duties under the International Health Regulations 
synergies  in  the  reporting  can  be  expected.  In  addition,  Member  States  would  need  to 
dedicate staff capacities every five years to contribute to an external evaluation. 

With  a  more  systematic  and  structured  approach  synergies  in  the  work  invested  by 
Commission staff can be expected and no additional administrative burden. 

Additional efforts would need to be undertaken by improving coordination with existing 
crisis notification tools and alert mechanisms; however, as contacts to these instruments 
are already in place, the additional investment for which human resources are needed can 
be  considered  marginal.  This  additional  work  can  be  done  by  available  staff  and 
assignment to national experts. 

Increase in administration would have to be expected during the setting up phase of the 
proposed  mechanism  for  joint  procurement  of  medical  countermeasures  in  form  of 
additional  staff  and  administrative  burden  for  the  entity  in  charge  of  operating  the 
contract  (see  details  under  financial  implications)  but  for  those  Member  States  that 
envisage  adequate  provision  and  preventive  measures  for  a  future  pandemic  the 

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administrative procedures have to be implemented any way. This task might be assigned 
to the Commission, there are however options that external support is requested for this 
task,  e.g.  by  assigning  this  task  to  an  Agency  or  Body  in  charge  of  procurement  or 
contract management. 

These administrative effects would decrease during the running of the contract prior to a 
cross-border  health  threat.  In  the  case  of  an  outbreak  or  a  public  health  event  which 
would require the activation of the contract, the administrative needs would rise steeply: 
However,  for  the  participating  countries  the  proposed  mechanism  will  result  in  a 
significant reduction of administrative burden as it would enable the pooling of different 
skills and expertise between national authorities109. 

EU  added  value:  Under  option  3,  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 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  add  value  to  strengthening 
the preparedness and response capacity to deal with cross-border health threats across the 
EU. 

Impact  at  international  level:  Better  coordination  in  the  EU  of  the  International  Health 
Regulations implementation by the Member States and closer collaboration between the 
EU  and  WHO  on  preparedness  for  and  response  to  public  health  emergencies  of 
international  concern  would  contribute  to  enhance  global  health  security.  It  would 
contribute to better control the spread of diseases internationally from and to the EU e.g. 
through  exchange  of  information  and  good  practice  with  global  partners  and  3rd 
countries. In this context improved public health risk assessment and management could 
be undertaken more effectively at international level when the EU has defined a common 
approach  on  serious  cross-border  threats  to  health  and  pre-established  procedures  on 
international cooperation. 

9.  COMPARING THE IMPACTS OF THE OPTIONS 

Based on the impact analysis, the criteria for comparing the impact of the three options 
are: improved impacts in the public health area, social and economic impacts, financial 
implications,  administrative  burden,  EU  added  value  and  impact  at  international  level. 
The options are rated according to their impact against these key criteria. Policy option 1, 
the  status  quo/baseline  scenario,  is  set  at  zero  (neutral)  and  the  impacts  of  the  policy 
options two and three are expressed as net changes compared to the status quo.110 

As  option  1  is  about  status  quo  and  refers  to  the  baseline  scenario,  these  conclusions 
focus on options 2 and 3, where new impacts can be expected. 

109 

110 

EC  Green  Public  Procurement  Training  Toolkit  –  Joint  Procurement  Fact  Sheet, 
http://ec.europa.eu/environment/gpp/pdf/toolkit/module1_factsheet_joint_procurement.pdf  
Annex  20  provides  an  overview  of  the  ratings  for  the  different  options  based  on  the  detailed 
analysis set out in annex 19. 

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Following  the  analysis  of  impacts  as  summarised  in  annex  20,  there  are  a  number  of 
differences  between  options  2  and  3,  which  demonstrate  the  added  value  of  choosing 
option 3. 

As  regards  the  public  health  impact,  both  options  improve  the  overall  situation  for 
preparedness  and  response  to  a  crisis.  However,  as  option  2  depends  on  a  voluntary 
approach  the  positive  impacts  would  not  be  guaranteed  as  they  would  rely  only  on  the 
commitment  of  the  Member  States.  In  comparison,  option  3  which  sets  out  a  new 
coherent framework on preparedness planning at the EU level, also establishes common 
mandatory standards that would lead to considerably improved coordination at EU level. 

As regards risk notification and assessment, both options 2 and 3 strengthen cooperation 
in  this  area.  However,  option  3  would  provide for  a  more  coherent  and  comprehensive 
approach as a coordination system would be put in place and the Member States affected 
by a crisis would consent to notify all serious cross-border health threats at the EU level. 
In addition, the risk assessment capacities would be improved by filling gaps in current 
risk assessment capacities under option 3. 

In the area of risk and crisis management, option 2 would improve the overall situation as 
the  two  committees'  mandates  would  be  clarified.  However,  option  3  would  merge  the 
two  committees,  providing  a  sound  basis  for  crisis  management  of  all  serious  cross-
border health threats. 

Risk and crisis communication would be also be improved under both options, but under 
option  3  the  linking  of  communicators  and  crisis  managers  would  ensure  that 
communication strategies could be developed within the overall approach of response to 
public health events. 

Concerning the financial and administrative implications these would result in negative 
impacts  due  to  additional  administrative  requirements  and  financial  input  -  though 
modest  -  for  both  options.  Nevertheless,  in  particular  as  regards  option  3,  it  can  be 
considered that the qualitative improvements and the EU added value under this option 
outweigh the costs and administrative burden in the long run. Option 3 will also set up 
the  legal  basis  for  the  joint  procurement  mechanism  which  would  require  increased 
administrative  resources  during  the  setting  up  period,  but  once  operational,  the  overall 
administrative  burden  is  expected  to  be  less  as  compared  to  procurement  at  national 
level.  In  addition,  joint  procurement  would  lead  to  stronger  purchasing  powers  for  the 
Member States and economies of scale. 

As regards the social impacts, option 2 could contribute to improved communication as 
Member  States  would  be  committed 
for 
communication.  However,  option  3  would  provide  for  a  much  stronger  basis  for 
improved communication as there would be an EU level communication strategy which 
would  ensure  consistency  of  messages  to  the  public.  Moreover,  option  3  would 
significantly increase access to medical countermeasures to citizens across the EU. 

implement  common  guidelines 

to 

Concerning  the  economic  impacts,  option  3  is  favoured  over  option  2,  as,  due  to 
increased cross-sectoral collaboration and legally binding measures, under option 3 other 
sectors of the society would be better prepared for the negative repercussions of a public 
health event. 

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Finally,  when  considering  the  international  impact,  option  3  would  also  contribute  to  a 
closer collaboration between the EU and the World Health Organisation as well as other 
relevant global partners in the area of health security. 

10. 

CONCLUSIONS AND PROPOSAL FOR IMPLEMENTATION 

On the basis of the comparison of impacts of the three options as presented in annex 13 
and the detailed impact assessment for each option separately provided in annexes 16 and 
19, it can be stated that the actions proposed under option 3 address most effectively the 
objectives  set  out  under  the  Health  Security  initiative  and  have  positive  social  and 
economic impacts. 

Option  3  has  the  strongest  health  impacts  as  it  provides  an  improved  protection  of 
citizens  against  serious  cross-border  health  threats.  The  key  reason  for  this  is  that  it 
proposes  a  comprehensive  framework  for  health  security  structures  and  systems 
including obligations on Member States in terms of preparedness and response planning. 
It makes notifications at  EU level mandatory and establishes a clear mechanism  with a 
clear  mandate  to  address  all  types  of  public  health  events  by  merging  two  existing 
committees into one. 

Option  3  also  offers  the  best  possible  EU  added  value  and  best  fulfils  the  fundamental 
goals of the Lisbon Treaty of ensuring a high level of human health protection against all 
serious cross-border health threats. 

Under this option Member States would need to be strongly committed to cooperate and 
to  review  their  arrangements  in  the  context  of  activities  in  other  areas.  The  overall 
administrative  burden  and  additional  financial  implications  are  expected  to  be  not 
substantial as Member States have already to comply with requirements existing in other 
areas.  

In this regard Member States will be faced with the following implications  

Ensure  that  the  transposition  of  international  standards  on  health  security  is  done  in  a 
coherent and coordinated manner at EU level. The Member States are already obliged to 
the 
implement 
implementation would be done in a coordinated way across all EU Member States. This 
would  be  done  through  binding  principles  and  procedures  for  meeting  core  capacity 
standards for preparedness and response planning as set out in the IHR. 

the  International  Health  Regulations  (IHR).  In 

initiative 

this 

• 

• 

• 

Provide  relevant  information  on  serious  cross-border  threats  to  health 
collected through monitoring systems by using agreed case definitions. 

Notify  measures  and  events  of  serious  cross-border  threats  to  health. 
These will include events which are also reported under the International 
Health Regulations.  

Coordinate public health measures at the EU level on serious cross-border 
threats  to  health.  This  coordination  would  involve  agreeing  to  binding 
procedures 
and 
coordination.  

consultations 

information 

concerning 

exchange, 

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• 

Voluntarily  participate  in  joint  actions  in  particular  related  to  joint 
procurement  for  pandemic  influenza  vaccines  and  in  mutual  agreements 
such as common vaccination campaigns. 

Option 3 will ensure that European citizens are equally protected against threats caused 
by chemical, biological or environmental events as they are currently for communicable 
diseases.  Under  the  improved  conditions  for  preparedness  in  particular  for  joint 
procurement  mechanisms  on  medical  countermeasure  additional  protection  is  also 
ensured for communicable disease, especially pandemic influenza. 

It  will  strengthen  the  capacity  of  the  EU  and  Member  States  to  manage  public  health 
crises  better  than  today  not  only  at  European  level  but  also  in  a  global  context  as 
provisions at European level will be aligned to International Health Regulations. 

Overall  this  option  would  not  only  strengthen  the  preparedness  provisions  for  serious 
cross border threats to health caused by chemical, biological and environmental events, it 
would also make existing guidelines for communicable diseases more enforceable.  

The  legal  form  under  this  option  would  be  a  legislative  act  of  the  European  Union 
adopted by ordinary legislative procedure that would repeal but take over the provisions 
of the current EP and Council Decision of 1998 on communicable diseases.  

The  legislative  proposal  would  have  articles  on  the  subject  matter,  scope,  definitions, 
preparedness  and  response  planning, 
joint  procurement  of  medical  countermeasures, 
epidemiological surveillance and monitoring, early warning and response system, public health 
risk assessment, coordination of response, health security committee, exercise of the delegation, 
urgency  procedure,  designation  of  national  authorities  and  representatives,  collaboration  with 
third  countries  and  international  organisations,  protection  of  personal  data,  and  reports.  An 
annex  would  provide  a  list  of  communicable  diseases  and  special  health  issues  subject  to 
epidemiological surveillance. 

The proposal would simplify the existing legislation. It would improve transparency due 
to  less  implementing  measures  (all  decisions  implementing  decision  2119/98  will  be 
replaced by one annex); current overlaps with ECDC mandate will be cleared and only 
one committee with a clear mandate would be established to manage all types of health 
crises. 

11. 

MONITORING AND EVALUATION  

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.  

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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)111  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 in annex 21. 

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. 

111 

More information on the Global Health Security Initiative can be found in the Commission Staff 
Working  Document  on Health  Security  in  the  European Union  and  Internationally,  available  at: 
http://ec.europa.eu/health/preparedness_response/docs/commission_staff_healthsecurity_en.pdf 

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12. 

ANNEXES AND APPENDICES 

ANNEXES 

1: Treaty of the Functioning of the EU (Lisbon Treaty), Article 168 

2: The Health Security Committee 

3:  Requests  of  Member  States  to  review  the  health  security  framework  and  pandemic 
preparedness planning 

4: Existing legal framework for communicable diseases, Decision 2119/98 and European 
Centre  for  Disease  Prevention  and  Control  (ECDC)  and  implementation  of  the 
framework 

5: The International Health Regulations (IHR)  

6. Examples of effects 

7:  EU  mechanisms  and  strategies  for  disaster  prevention  and  control  –  the  security 
framework within the European Commission 

8: Business continuity and preparedness panning at EU and international level 

9: The Health Programmes at European level 

10: Overview of Objectives of the Health Security Initiative 

11: Notification of serious cross border health threats to the WHO under IHR 

12: Problems and public health consequences 

13: Overview of measures proposed under the three options 

14: Opinions of stakeholders on the three options  

15: Detailed tasks and obligations for Member States and the Commission under option 
3 – legal proposal 

16:  Description  of  actions  proposed  under  the  options  and  their  implications  for  the 
health sector 

17: Examples of potential complementary EU stockpiles 

18: Illustration of the joint procurement mechanism for medical countermeasures 

19: Analysis of the impacts of the three options 

20: Comparison of the policy options 

21: Monitoring the implementation of suggested actions 

22: Glossary 

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23: Reference Documents and Links 

APPENDICES 

1.  Report  on  the  outcome  of  the  "Stakeholder  consultation  on  Health  Security  in  the 
European Union" 

2. Structures for preparedness and response to cross-border health threats 

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Annex 1: Treaty on the functioning of the European Union (Lisbon Treaty), Article 168 

TITLE XIV, PUBLIC HEALTH, Article 168(ex Article 152 TEC) 

1.  A  high  level  of  human  health  protection  shall  be  ensured  in  the  definition  and 
implementation of all Union policies and activities. 

Union action, which shall complement national policies, shall be directed towards improving 
public  health,  preventing  physical  and  mental  illness  and  diseases,  and  obviating  sources  of 
danger  to  physical  and  mental  health.  Such  action  shall  cover  the  fight  against  the  major 
health  scourges,  by  promoting  research  into  their  causes,  their  transmission  and  their 
prevention, as well as health information and education, and monitoring, early warning of and 
combating serious cross-border threats to health. 

The  Union  shall  complement  the  Member  States'  action  in  reducing  drugs-related  health 
damage, including information and prevention. 

2. The Union shall encourage cooperation between the Member States in the areas referred to 
in this Article and, if necessary, lend support to their action. It shall in particular encourage 
cooperation  between  the  Member  States  to  improve  the  complementarity  of  their  health 
services in cross-border areas. 

Member  States  shall,  in  liaison  with  the  Commission,  coordinate  among  themselves  their 
policies  and  programmes  in  the  areas  referred  to  in  paragraph  1.  The  Commission  may,  in 
close contact with the Member States, take any useful initiative to promote such coordination, 
in  particular  initiatives  aiming  at  the  establishment  of  guidelines  and  indicators,  the 
organisation of exchange of best practice, and the preparation of the necessary elements for 
periodic monitoring and evaluation. The European Parliament shall be kept fully informed. 

3.  The  Union  and  the  Member  States  shall  foster  cooperation  with  third  countries  and  the 
competent international organisations in the sphere of public health. 

4.  By  way  of  derogation  from  Article  2(5)  and  Article  6(a)  and  in  accordance  with  Article 
4(2)(k)  the  European  Parliament  and  the  Council,  acting  in  accordance  with  the  ordinary 
legislative  procedure  and  after  consulting  the  Economic  and  Social  Committee  and  the 
Committee of the Regions, shall contribute to the achievement of the objectives referred to in 
this Article through adopting in order to meet common safety concerns: 

(a) measures setting high standards of quality and safety of organs and substances of human 
origin, blood and blood derivatives; these measures shall not prevent any Member State from 
maintaining or introducing more stringent protective measures; 

(b) measures in the veterinary and phytosanitary fields which have as their direct objective the 
protection of public health; 

(c) measures setting high standards of quality and safety for medicinal products and devices 
for medical use. 

5.  The  European  Parliament  and  the  Council,  acting  in  accordance  with  the  ordinary 
legislative  procedure  and  after  consulting  the  Economic  and  Social  Committee  and  the 
Committee  of  the  Regions,  may  also  adopt  incentive  measures  designed  to  protect  and 

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improve  human  health  and  in  particular  to  combat  the  major  cross-border  health  scourges, 
measures concerning monitoring, early warning of and combating serious cross-border threats 
to  health,  and  measures  which  have  as  their  direct  objective  the  protection  of  public  health 
regarding  tobacco  and  the  abuse  of  alcohol,  excluding  any  harmonisation  of  the  laws  and 
regulations of the Member States. 

6. The Council, on a proposal from the Commission, may also adopt recommendations for the 
purposes set out in this Article. 

7.  Union  action  shall  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. 
The responsibilities of the Member States shall include the management of health services and 
medical care and the allocation of the resources assigned to them. The measures referred to in 
paragraph 4(a) shall not affect national provisions on the donation or medical use of organs 
and blood. 

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Annex 2: The Health Security Committee 

1. History 

In  the  aftermath  of  the  terrorist  attacks  in  2001,  and  in  particular  the  deliberate  release  of 
Anthrax toxins in the US, the EU health ministers decided to set up the EU Health Security 
Committee  (HSC)112  as  an  informal  structure  for  better  coordination  of  public  health  risk 
assessment  and  management  on  other  serious  cross-border  health  threats  in  the  EU.  At  the 
beginning  the  HSC  mandate  was  limited  to  tackling  bioterrorism;  subsequently  it  has  been 
extended to cover all types of public health-related crisis113 and further prolonged114. 

The Health Security Committee is not a Comitology committee. Representatives of the Health 
authorities of the Member States meet on a regular basis, 1 -2 times per year in face-to-face 
meetings. The Committee is operating on the basis of a work programme according to their 
mandate  that  is  dedicated  to  preparedness  and  response  planning  in  the  field  of  generic 
preparedness, influenza preparedness, CBRN threats and communication. 

The Secretariat of the Committee is ensured by the Commission and regular reports about the 
activities  of  the  Committee  are  provided.  The  latest  report  "Staff  Working  Paper  on  the 
activities  of  the  Health  Security  Committee  during  the  period  from  November  2009  to 
December 2010" was published on 22 July 2011.115  

2. Mandate  

According  to  the  Council  Conclusions  on  HSC  of  22  February  2007  the  current  Terms  of 
Reference are the following: 

• 

• 

• 

• 

• 

112 

113 

114 

115 

exchange  information  on  health-related  threats  from  acts  of  terrorism  or  any 
deliberate release of biological or other agents with intent to harm health; 

share  information  and  experience  on  preparedness  and  response  plans  and  crisis 
management strategies; 

be able to communicate rapidly in case of health-related crises; 

advise Health Ministers and the European Commission services on preparedness and 
response as well as on coordination of emergency planning at EU level; 

share  and  coordinate  health-related  crisis  responses  by  Member  States  and  the 
Commission; 

Presidency Conclusions of 15 November 2001 on bioterrorism: 
(http://europa.eu/rapid/pressReleasesAction.do?reference=PRES/01/415&format=HTML&aged=0&lg=
es&guiLanguage=en) 
Council Conclusions of 22 February 2007 on health security committee: 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf 
Council conclusions of 13 September 2010 on lessons learned from A/H1N1 pandemic – health security 
in  the  European  Union  http://register.consilium.europa.eu/pdf/en/10/st12/st12665.en10.pdf;  see  further 
details  in  annex  2  and  latest  activity  report:  Commission  staff  working  paper  on  the  activities  of  the 
Health Security Committee during the period from November 2009 to December 2010, SEC(2011) 984 
final; 22.7.2011  
http://ec.europa.eu/health/preparedness_response/docs/hsc_activities_2009-2010_en.pdf 

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• 

facilitate and support coordination and cooperation efforts and initiatives undertaken 
at EU and international level and help contribute to their implementation at national 
level. 

3. Development and health issues addressed 

Over  the  years  the  committee  has  established  a  solid  basis  for  preparedness  activities  and 
monitors  the  activities  in  the  health  areas.  It  exchanges  information  of  mutual  interests  and 
evaluates  health  events.  It  is  a  discussion  forum  and  such  the  only  existing  platform  at 
European level where the health authorities responsible for public health in humans meet and 
exchange regularly. These certainly have an effect in bringing Member States closer together 
and consult on a variety of options in public health. 

The Committee can also be consulted in cases of emergencies and crises or to discuss urgent 
matters via audio or video conferences. In this case coordination can be arranged and views 
exchanged. 

Examples of health issues addressed by the Health Security Committee are the following: 

In January 2010 discussion about the investigation of the Council of Europe into vaccination 
issues  in  the  context  of  pandemic  H1N1,  and  on  the  anthrax  outbreak  in  Scotland  and 
Germany, which led to the death of several drug users; 

In  February  2010  discussion  to  inform  on  the  evaluation  of  the  management  of  pandemic 
H1N1, to update information about IDU anthrax cases; 

In  April  2010  discussion  on  the  evaluation  of  pandemic  H1N1  and  the  preparations  for  the 
Belgian presidency Conference on Lessons learnt from pandemic H1N1; 

In  April  2010:  urgent  audio  conference  in  order  to  discuss  the  public  health  risk  after  the 
volcano eruption in Iceland. 

However, given its informal character there are no examples that the Committee has proposed 
strong  ,  agreed  and  shared  action  which  is  then  be  implemented  by  the  member  States  and 
leads  to  a  coherent  response.  There  is  no  obligation  for  the  Committee  to  propose 
recommendations,  to  find  a  common  view,  there  is  not  voting  according  to  the  usual 
principles  of  comitology  and  hence  the  Committee  operates  entirely  on  voluntary  and  non-
binding arrangements for Member States. 

The handling of the pandemic influenza can be considered a good example where the lack of 
proper recommendations and implementation led to different approaches of Member States to 
address the crises depending on their own assessment of the risk and capacity to cope with. As 
proven  by  evaluations  at  the  level  of  Member  States,  WHO,  the  Commission  and  the 
European  Parliament  this  situation  has  led  to  immense  costs  for  buying  vaccines.  The 
incoherent and contradictory communication of the different stakeholders has had devastating 
effects related to the trust of citizens in health authorities. 

A stronger mandate of the Committee and the use of "mutual agreements" would have been 
more effective and less costly for Europe. 

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Annex  3:  Requests  of  Member  States  to  review  the  health  security  framework  and 
pandemic preparedness planning 

During past Council meetings the Member States have several times called for a review of the 
health security framework and the need for reviewed pandemic preparedness planning. 

In  its  conclusions  of  22  February  2007116,  the  Council  called  the  Commission  "to  come 
forward as appropriate with a proposal for a long-term solution for the Community framework 
for health security taking into account the structures in all relevant sectors to ensure that work 
is taken forward in the most appropriate forum, avoiding duplication and supporting effective 
cross-sectoral collaboration". 

In  its  conclusions  of  16  December  2008117,  the  Council  of  the  European  Union  adopted 
conclusions on health security inviting the Member States and the Commission 'to strengthen 
their coordination in facing public health emergencies of international concern within the EU, 
as defined in the International Health Regulations (IHR) 2005. 

The Council also invited the Commission to "take into account the inter-sectoral dimension of 
preparing  for  pandemic  influenza...,  to  develop the  system  of  monitoring,  preparation,  early 
warning  and  response  at  European  level  to  adapt  it  to  the  challenges  of  public  health 
emergencies involving more than one Member State, taking account inter alia of the entry into 
force  of  the  IHR  2005,  the  evaluation  of  the  ECDC  and  the  need  to  consider  providing  the 
HSC with a legal basis"… and 'to present, in 2010, a communication proposing a long-term 
solution  for  the  Community  framework  for  health  security  taking  into  account  the  existing 
structures  in  all  relevant  sectors  and  the  need  to  avoid  duplication  accompanied,  where 
appropriate, by a legislative proposal and adapt the status of the HSC to the health challenges 
of the future, taking account of the mandate of the ECDC". 

In its conclusions of 13 September 2010118, the Council invited the Commission to:  

–  revise the Pandemic Preparedness Plan of the EU, taking into account lessons learned from 
the A(H1N1) pandemic, the national and European evaluations concerned and in coherence 
with the WHO review of the IHR(2005) and the international framework, giving particular 
attention  to  the  need  for  inter-sectoral  preparedness  for  a  pandemic  and  to  reducing  the 
impact of a pandemic on society, to ensure that the response is flexible proportionate and 
adapted to the severity of the threat; 

–  report on and develop, as soon as possible and no later than December 2010, a mechanism 
for  joint  procurement  of  vaccines  and  antiviral  medication  which  allows  Member  States, 
on  a  voluntary  basis,  common  acquisition  of  these  products  or  common  approaches  to 
contract  negotiations  with  the  industry,  clearly  addressing  issues  such  as  liability, 
availability and price of medicinal products as well as confidentiality; 

116 

117 

118 

Council conclusions of 22 February 2007 on Health Security Committee, 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf 
Council conclusions of 16 December 2008 on health security, add links 
http://www.consilium.europa.eu/ueDocs/cms_Data/docs/pressData/en/lsa/104770.pdf 
Council conclusions of 13 September 2010 on lessons learned from the A/H1N1 pandemic – health 
security in the European Union, available at: 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/EN/genaff/116489.pdf; 
http://register.consilium.europa.eu/pdf/en/10/st12/st12665.en10.pdf 

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–  improve  the  fast  registration  procedure  for  vaccines,  as  regards,  inter  alia,  making  it 
suitable for different influenza strains, varying levels of severity and differences in target 
population groups, the format and content of the  application  for  marketing authorization, 
the requirements on packaging and leaflets, the availability of data from clinical trials, the 
scientific  pre-  and  post  marketing  evaluation  and  transparency  of  communication  on  the 
procedure whilst safeguarding the quality, safety and efficacy of the vaccines; 

–  present, in 2011, a proposal for a long-term solution for health security taking into account 
the  outcome  of  the  examination  of  the  options  for  the  legal  basis  of  the  HSC  referred  to 
above and the existing structures in all relevant sectors and the need to avoid duplication of 
work, and in the interim, to ensure that the Council is regularly updated on the work of the 
HSC. 

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Annex  4:  Existing  legal  framework  for  communicable  diseases,  Decision  2119/98  and 
European Centre for disease prevention and control (ECDC) and implementation of the 
framework 

Since 1998 legal provisions on communicable diseases have been adopted. The EU network 
for  surveillance  and  control  of  communicable  diseases  allows  their  implementation119  and 
specific  mechanisms  to  monitor,  alert  and  coordinate  the  EU  response  to  communicable 
diseases have been put in place120. These mechanisms have been further reinforced in 2004 by 
the establishment of the European Centre for Disease Prevention and Control121 (ECDC). 

Under these provisions EU Member States must monitor a number of communicable diseases 
(46)  and  special  health  issues  (2:  Antimicrobial  resistance  and  health  care  associated 
infections). They also have to notify all the acute events due to communicable diseases which 
have  a  real  or  potential  impact  at  EU  level,  including  any  information  related  to  the  public 
health  measures  undertaken  to  respond  to  such  events.  The  notification  of  the  acute  events 
takes  place  through  the  Early  Warning  and  Response  System  (EWRS),  the  EU  Rapid  Alert 
System  for  communicable  diseases.  Such  notification  helps  in  coordinating  the  response  to 
events, which, because of their EU impact, need to be put into practice in the same way and 
possibly at the same time by all the concerned Member States. In practice it would be useless, 
and even counterproductive, to apply different measures to fight the same outbreak spreading 
among  different  Member  States.  In  addition,  the  alert  system  for  communicable  diseases  is 
linked to the International Health Regulations and therefore the notification by Member States 
is  issued  simultaneously  to  the  EU  Early  Warning  and  Response  System  (EWRS)  and  the 
World Health Organisation. 

When  an  event  is  notified  the  Commission  helps  the  Member  States  in  coordinating  an  EU 
response with the help of the appropriate EU Agencies, in the case of communicable diseases 
mainly  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC).  The  ECDC 
provides all the necessary input for a robust and scientific based assessment of the situation. 
This assessment, called "Risk Assessment" is shared through the EWRS and it is the basis to 
develop and choose, with the coordination of the Commission, the best options to respond at 
EU level to the event.  

119 

120 

121 

See  annex  4  and  also  Decision  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) 
Reports on the operation of the EWRS are prepared regularly, listing the events communicated through 
the system and coordination of measures undertaken 
http://ec.europa.eu/health/communicable_diseases/early_warning/comm_legislation_en.htm; Most 
recent examples of the use of the mechanism are the pandemic H1N1 event in 2009; 
http://ec.europa.eu/health/communicable_diseases/diseases/influenza/h1n1/index_en.htm#fragment2; 
and the E. coli STEC O104 outbreak in 2011; 
http://ec.europa.eu/food/food/coli_outbreak_germany_en.htm; As regards the events treated under the 
EU Health Security Committee, annual reports are also prepared, describing the main activities, 
including coordination of management of events; 
http://ec.europa.eu/health/preparedness_response/docs/commission_staff_healthsecurity_en.pdf 
Examples of recent activity of the Committee include management of pandemic H1N1 in 2009 and a 
multi state incident of anthrax contaminated heroin 
http://ec.europa.eu/health/preparedness_response/hsc/index_en.htm 
Regulation (EC) 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing 
a European centre for disease prevention and control (OJ L 142, 30.4.2004, p.1) 

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A number of events illustrate the benefits of the mechanism currently in place.  

EU case definitions of specific conditions are agreed upon so that all the Member States apply 
the  same  criteria  in  reporting  an  outbreak.  This  has  been  proved  of  crucial  importance  not 
only during the recent E. coli outbreak (2011), but also during the SARS epidemic (2003), the 
H5N1 avian influenza scare (2004), a high impact event of rabies in France (2003) and during 
events caused by laboratory incidents when it was of pivotal importance to quickly identify all 
people exposed in order to treat them.  

During the H1N1 influenza pandemic the adoption of technical guidance documents on risk 
group  to  be  vaccinated,  school  closure  and  travel  advice  was  crucial  in  sharing  common 
decision  principles  to  avoid  an  inconsistent  response  across  the  EU.  Also  during  SARS  the 
adoption of EU guidance documents helped Member States to have a shared approach to fight 
quickly new and not well know threats. 

Information  sharing  of  personal  data  in  full  compliance  with  the  EU  legislation  on  data 
protection and through a secured informatics tool like the EWRS has helped Member States to 
implement  contact  tracing  activities  of  persons  who  have  been  contaminated  or  exposed  to 
infectious agents in order to have them treated with a matter of urgency. This happened with 
SARS,  H5N1  avian  influenza,  meningitis,  rabies,  legionellosis,  and  a  number  of  dangerous 
hemorrhagic diseases like Ebola, Marburg, and Lassa fever. 

The  consistency  in  the  approach  to  address  communicable  diseases  across  Member  States 
ensures  that  measures  to  tackle  communicable  diseases  are  being  handled  effectively  and 
efficiently  at  EU  level;  and,  in  parallel,  that  WHO  is  also  informed  and,  if  need  be,  can  be 
involved directly.  

Community  network  for  the  prevention  and  control  of  communicable  diseases  under 
Decision 2119/98/EC 

The  Community  network  two  parts:  (1)  epidemiological  surveillance  and  (2)  the  early 
warning and response system. 

(1)  The  epidemiological  surveillance  part  of  the  Community  network  is  composed  of 
structures and/or authorities competent at national level for collecting information relating to 
epidemiological  surveillance  of  communicable  diseases122.  It  has  been  progressively  taken 
over  by  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC)  since  the  EU 
Agency  became  operational  on  20  May  2005.  Now,  national  competent  bodies  for 
surveillance have the obligation to provide all necessary information for surveillance purposes 
to the ECDC under the founding regulation123. 

(2)  The  Early  Warning  and  Response  System  (EWRS)  is  a  network  formed  by  the 
Commission  and  competent  public  health  authorities  in  each  MS  responsible  for  measures 
which may be required to protect public health. It is responsible for notifications at EU level 

122 
123 

See Article 1 of Decision 2119/98/EC. 
See Article 2 of Regulation (EC) 851/2004 

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of  events  of  communicable  diseases  of  Community  relevance  and  of  related  public  health 
measures as well as for coordination of responses at EU level124. 

In  addition  to  the  Community  network  for  the  prevention  and  control  of  communicable 
diseases, Decision 2119/98 has empowered the Commission to take binding measures via the 
comitology procedure, e.g. new case definitions for communicable diseases (pandemic H1N1) 
according to the regulatory procedure with scrutiny (RPS) and the examination procedure125. 

For detailed information see the annual EWRS reports: 

• 

• 

• 

Report from the Commission to the Council and the European Parliament On 
the  operation  of  the  Early  Warning  and  Response  System  (EWRS)  of  the 
Community  Network  for  the  epidemiological  surveillance  and  control  of 
communicable  diseases  during  2006  and  2007  (Decision  2000/57/EC) 
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0228:FIN:EN:PDF  

Report from the Commission to the Council and the European Parliament On 
the  operation  of  the  Early  Warning  and  Response  Systems  (EWRS)  of  the 
Community  Network  for  the  epidemiological  surveillance  and  control  of 
communicable  diseases  during  years  2004  and  2005  (Decision  2000/57/EC) 
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2007:0121:FIN:EN:PDF  

Report  from  the  Commission  to  the  Council  and  the  European  Parliament  on 
the  operation  of  the  Early  Warning  and  Response  System  of  the  community 
network  for  the  epidemiological  surveillance  and  control  of  communicable 
(decision  2000/57/EC)  during  2002  and  2003  http://eur-
diseases 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2005:0104:FIN:EN:PDF  

N.B.  Legislation  on  communicable  diseases  is  outdated  and  does  not  yet  take  into 
consideration  the  establishment  of  the  European  Centre  for  disease  control  and  prevention 
(ECDC)  and  the  International  Health  Regulation  (IHR);  there  is  also  an  issue  related  to  the 
parallel existence of the EWRS network and the Health Security Committee. Action requested 
in these two areas is purely technical and hence not subject to this impact assessment. 

124 

125 

In the area of communicable diseases the EWRS performs the same activities as the EU Health Security 
Committee  with  the  exception  of  preparedness  matters  (see  the  terms  of  reference  of  the  EU  Health 
Security Committee). 
These provisions will need to be reviewed in accordance with the rules on non-legislative acts (see inter 
alia Articles 290 and 291 of TFEU. 

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Annex 5: The International Health Regulations (IHR)126 

Since 15 June 2007 the International Health Regulations (2005) have entered into force. This 
legally-binding agreement provides a new framework for the coordination of the management 
of events that may constitute a public health emergency of international concern (PHEIC) and 
is expected to improve the capacity of all State Parties who have signed it (194 worldwide) to 
detect, assess, notify and respond to public health threats. The "old" IHR were focused only 
on  a  handful  of  specific  communicable  diseases  while  the  current  ones  are  addressing  all 
kinds  of  public  health  threats  (e.g.  chemical,  radiological,  environmental  etc.)  as  well  as  all 
communicable diseases causing public health emergencies. 

Countries  that  are  States  Parties  to  the  Regulations  have  two  years  to  assess  their  core 
capacities and develop national action plans followed by three years to meet the requirements 
of the Regulations  regarding their national surveillance and response systems as well as the 
requirements  at  designated  airports,  ports  and  certain  ground  crossings.  IHR  should  be 
implemented by 2016. 

"Core capacity" comprises the minimum requirements that a State Party should have in order 
to detect, assess, notify and respond to public health threats. Currently countries, including all 
EU Member States have to report on progress to the WHO annually on their core capacities  

It would enhance the preparedness of the EU to respond to future crises if compatible systems 
would  be  established  and  agreement  on  the  implementation  of  these  capacities  would  be 
reached at EU level. In addition EU criteria for notification should be established as the IHR 
criteria  for  notification  are  very  basic  so  that  developing  countries  can  cope  with  the 
requirements.  Health  threats  in  the  past  considered  as  threats  at  European  level  were  not 
notified under the IHR. For example this was the case for Melamine contaminated milk from 
China. 

However  there  are  weaknesses  in  the  IHR  for  example  they  do  not  require  MS  to  transfer 
biological  material  for  analysis  in  the  sophisticated  laboratories  needed  to  determine  the 
causes  of  unknown  threats  and  to  develop  diagnostic  tests  and  countermeasures  such  as 
vaccines.  They  are  also  global  in  their  nature  and  sometimes  have  difficulty  in  raising  and 
lowering alert levels at a regional level. For example under the IHR if proved impossible to 
lower the pandemic level in the 2009 in Europe in 2010 until August that year despite it being 
quite clear that transmission had ceased in the EU after January that year.  

126 

http://www.who.int/ihr/en/ 

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Annex 6: Examples of effects  

Table 1: Examples of effects from communicable disease outbreaks 

Health impacts 

Economic and other 
impacts 

Type of threat  Year of event 

1993-1998 

Mad cow 
disease and 
links to 
Creutzfeld- 
Jakob disease 

Affected 
persons 

1994 - 2008 at 
EU level: 209 
cases127 

Limited number of cases 
of variant Creutzfeldt-
Jakob disease; surveillance 
costs; diagnostic 
procedures; long lasting 
disease in patients; no 
treatment available. 

Suspension of free 
circulation of meat 
products; destruction of 
huge numbers of 
animals; import and 
export bans; 
reduced demands in beef 
products due to severe 
concern in public about 
effects of consuming 
beef products. 

Huge number of animals 
culled; the epidemic 
caused major economic 
problems to affected 
countries, e.g. collapse of 
trade with birds, collapse 
of tourism; mostly in 
South-East Asia where 
the losses were estimated 
at US$ 10 billion in GDP 
terms during December 
2003 to February 2006. 
130 131  

The estimated income 
loss ranges from 
US$12.3-28.4 billion for 
East and Southeast Asia 
as a whole133 

Quarantine measures; 
travel restrictions 

H5N1, avian 
influenza in 
humans 

2003-2011 

By August 
2011, 556 
cases 
worldwide, 
including 325 
deaths. 128 

Inter species infection 
from animal to human of 
H5N1 highly pathogenic 
influenza strain, affecting 
several continents. Fatality 
rate of 60%129 

SARS: Severe 
acute 
respiratory 
syndrome 

2002/2003 

8000 cases and 
800 deaths 
worldwide 132 

Severe disease rapidly 
spreading between 
continents; successful 
containment at the 
beginning avoided further 
spread. New infective 
agent. High lethality. No 
treatment. Health care 
workers highly impacted. 

Pandemic 
Influenza 

2009/2010 

A minimum of 
2900 deaths in 

Heavy burden on health 
services including 

Economic and societal 
disruption, particularly in 

127 
128 
129 
130 

131 
132 
133 

http://ec.europa.eu/food/animal/diseases/strategy/docs/Public_health_E_CJD_Surveillance_en.pdf 
http://www.who.int/csr/disease/avian_influenza/country/cases_table_2011_08_02/en/index.html 
http://www.who.int/csr/disease/avian_influenza/country/cases_table_2011_08_02/en/index.html 
UNESCAP  -  United  Nations  Economic  and  Social  Commission  for  Asia  and  the  Pacific.  Economic 
Impact of Avian Flu: Global Programme for Avian Influenza and Human Pandemic: Health, Nutrition 
and Population in East Asia and the Pacific (http://www.worldbank.org/). 
http://ideas.repec.org/h/izm/prcdng/200610.html 
http://www.who.int/csr/sars/country/table2004_04_21/en/index.html 
http://www.adb.org/Documents/EDRC/Policy_Briefs/PB015.pdf 

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H1N1 
(2009)134 

the EU with 
18000 deaths 
worldwide135 
136 

E. coli STEC 
O104 

2011 

3.910 human 
cases and 46 
deaths within 2 
months139 

intensive care; Initial 
contact tracing during 
assessment phase; Huge 
investment at national 
level in vaccines and 
antivirals; competition 
between MS in procuring 
vaccines (e.g. vaccination 
campaign in France cost 
662M€ 137; problems in 
maintaining public 
confidence in health 
measures. 

Overflowing intensive care 
units in Germany; 
shortages of medical 
equipment; pressure on 
laboratory capacity needed 
to examine a sufficient 
number of samples in a 
short time; special 
reporting and surveillance 
system ( medium and long 
term) Lack of 
effectiveness of WHO 
provisions under IHR. 
Problems in maintaining 
public confidence in health 
measures.140 

Mexico138; school 
closures; disruption for 
tourism and travel. 

Huge impacts on 
vegetable/agriculture 
sector in the EU; 227 
Mio EUR compensation 
scheme established by 
Commission to date141; 
import bans by third 
countries, in particular 
ban on EU export of 
fresh vegetables to 
Russia for 2 months with 
extrapolated costs of 
EUR 100 million142 

134 

135 
136 

137 
138 

139 

140 
141 

142 

All evaluations related to pandemic influenza H1N1 are published at: 
http://www.ecdc.europa.eu/en/healthtopics/pandemic_preparedness/pandemic_2009_evaluations/Pages/
pandemic_2009_evaluations.aspx  
http://www.who.int/csr/don/2010_07_02/en/index.html 
http://www.ecdc.europa.eu/en/activities/sciadvice/Lists/ECDC%20Reviews/ECDC_DispForm. 
aspx?List=512ff74f%2D77d4%2D4ad8%2Db6d6%2Dbf0f23083f30&ID=789 
http://www.ccomptes.fr/fr/CC/documents/RPA/5_lutte_contre_la_grippe_A_H1N1.pdf 
http://web.worldbank.org/WBSITE/EXTERNAL/NEWS/0,,content 
MDK:20663668~pagePK:34370~piPK:42770~theSitePK:4607,00.html 
Last ECDC update of 27 July 2011 after the declaration of the Robert Koch Institute in Germany on 26 
July that the outbreak was officially over: 
http://ecdc.europa.eu/en/activities/sciadvice/Lists/ECDC%20Reviews/ECDC_DispForm.aspx?List=512
ff74f%2D77d4%2D4ad8%2Db6d6%2Dbf0f23083f30&ID=1166&RootFolder=%2Fen%2Factivities%2
Fsciadvice%2FLists%2FECDC%20Reviews 
http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19889 
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/938&format= 
HTML&aged=0&language=EN&guiLanguage=en 
The total value of EU exports of fresh vegetables to Russia is around 600m euros a year; the ban lasted 
2 months (2 June - 8 August), hence extrapolated costs in the EU 100 million EUR 

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Table 2: Examples of effects of threats caused by chemical, biological and environmental 
events 

Year of 
event 

2010 

Affected 
persons 

Volcanic ash 
clouds 

2010 

Red 
Aluminium 
sludge spill in 
Hungary and 
in Danube 

Heat wave  

2003 

December 
2005 

Fire at the 
Buncefield 
Fuel Storage 
Depot, 
England  

8 persons 
died and 130 
individuals 
some in 
critical 
condition 
were treated 
in hospitals 
for burn 
injuries.145 
70,000 
excess deaths 
reported 
from 12 
European 
Countries. 146 

244 patients 
attended 
accident and 
emergency 
services in 
hospital. 
Minor 
injuries. 

Health impacts 

Economic and other impacts 

100,000 flights cancelled, 10M 
passengers unable to travel; 
disruption of business estimated up 
to 2.5 Billion € 144 

Damages to the environment; loss 
in production capacity as 
employees were unable to work due 
to intoxication. 

Estimation by United Nations 
Environmental Programme for the 
European Region was 13 Billion 
€. 147 

Explosion heard in France. Smoke 
cloud crossed Channel. Potential 
for international impact (France, 
Belgium, Netherlands as well as 
UK). 

Risk of exposure 
affecting persons with 
respiratory diseases; 
delays in delivery of 
organs for transplants 
because of 
interruption of 
transport143  
Exposure of 
population in several 
Member States to risk 
of poisoning  

Large numbers of 
elderly persons and 
persons with chronic 
disease requiring 
intensive care or 
suffering premature 
death. 
Concerns included the 
risk to health from 
smoke, contamination 
of the general 
environment 
(including soil, and 
exposure to debris), 
and other fallout from 
the smoke plume, as 
well as living or 
working under the 
smoke plume.148 

143 

144 
145 
146 

147 
148 

http://www.sergas.es/gal/DocumentacionTecnica/docs/SaudePublica/incidencias/ECDC%20 
Threat%20Assessment%20-%20Volcano%20in%20Iceland.pdf; 
http://www.efsa.europa.eu/en/efsajournal/doc/1593.pdf 
http://europa.eu/news/transport/2010/04/20100421_en.htm 
http://register.consilium.europa.eu/pdf/en/10/st14/st14910.en10.pdf 
http://www.euro.who.int/en/what-we-do/health-topics/environment-and-health/Climate-change/facts-
and-figures 
http://www.grid.unep.ch/product/publication/download/ew_heat_wave.fr.pdf 
http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1194947375551 

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Annex  7:  EU  mechanisms  and  strategies  for  disaster  prevention  and  control  –  the 
security framework within the European Commission 

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 crises149. 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 few150.  

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 
Commission's crisis management corporate system.  

level 

is  done 

through  ARGUS, 

the 

The Commission adopted on 23 December 2005 a Communication establishing “ARGUS”151 
as  the  Commission's  general  rapid  alert  system  for  major  crises  affecting  multiple  sectors. 
ARGUS is composed of a specific coordination process and an information network involving 
Directorates  General  and  services  in  the  Commission.  Following  five  years  of  operations, 
ARGUS is currently under review among others at improving the Commission's preparedness 
capacity. 

The Commission ensures broader internal coordination by means of an interservice 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.  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 a number of structures are in place at EU level: 

• 

149 
150 

151 

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);  

See detailed information in annex 7 
For  further  details,  please  see  the  "Inventory  of  Crisis  Management  Capacities  in  Commission  and 
Agencies" 
COM(2005) 662 final 

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• 

• 

Designated  networks  such  as  the  Animal  Disease  Notification  System  (ADNS), 
Rapid  Alert  System  for  Feed  and  Food  (RASFF),  European  Telecommunication 
Network  in  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;  

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 threat152. 

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, civil protection and external relations:  

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

This  Internal  Security  Strategy  was  adopted  in  November  2010  by  a  Commission 
Communication.  It  establishes  a  four  year  strategy  to  help  increase  Europe's  resilience  to 
crises and disasters, including hostile or accidental releases of disease agents and pathogens. 
The Health Security Initiative is explicitly mentioned as an element of the strategy as it will 
contribute to reinforcing the coordination of EU risk management through strengthening the 
existing  structures  and  mechanisms  to  tackle  health  threats.  Thus,  the  Health  Security 
Initiative will become part of a shared agenda for Member States, the European Parliament, 
the  Commission,  the  Council  and  European  agencies  to  reinforce  effective  fight  and 
prevention of serious and organised crime and terrorism and to strengthen resilience to natural 
and  man-made  disasters.  It  will  be  an  important  element  in  establishing  a  coherent  risk 
management  policy  linking  threat  and  risk  assessments  to  decision  making  as  envisaged  by 
the EU Internal Security Strategy. 

Action 2 of objective 5 is in particular relevant for the Health Security Initiative: 

OBJECTIVE 5: Increase Europe's resilience to crises and disasters 

The EU is exposed to an array of potential crises and disasters, such as those associated with 
climate  change  and  those  caused  by  terrorist  and  cyber  attacks  on  critical  infrastructure, 
hostile  or  accidental  releases  of  disease  agents  and  pathogens,  sudden  flu  outbreaks  and 
failures in infrastructure. These cross-sectoral threats call for improvements to long-standing 

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crisis and disaster management practices in terms of efficiency and coherence. They require 
both  solidarity  in  response,  and  responsibility  in  prevention  and  preparedness  with  an 
emphasis on better risk assessment and risk management at EU level of all potential hazards. 

Action 2: An all-hazards approach to threat and risk assessment 

By  the  end  of  2010  the  Commission  will  develop,  together  with  Member  States,  EU  risk 
assessment  and  mapping  guidelines  for  disaster  management,  based  on  a  multi-hazard  and 
multi-risk approach, covering in principle all natural and man-made disasters. By the end of 
2011, Member States should develop national approaches to risk management, including risk 
analyses.  On  this  basis,  the  Commission  will  prepare,  by  the  end  of  2012,  a  cross-sectoral 
overview  of  the  major  natural  and  man-made  risks  that  the  EU  may  face  in  the  future. 
Furthermore  the  Commission  initiative  on  health  security  planned  for  2011  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 initiative will be instrumental to strengthen chemical and biological security in the EU as 
set out in the CBRN action plan.  

In  the  area  of  security,  the  Commission  adopted  on  24  June  2009  a  Communication  on 
"Strengthening  Chemical,  Biological,  Radiological  and  Nuclear  Security  in  the  European 
Union  –  an  EU  CBRN  Action  Plan"  accompanied  by  the  Commission  Staff  Working 
Document  on  "Bridging  security  and  health:  towards  identification  of  good  practices  and 
recommendations on response to CBRN incidents and security of CBRN substances"153.  

This plan is built on an all hazard approach to combat threats for society and includes health 
threats  preparedness  and  response  as  one  of  its  main  columns.  Risk  prevention  and  control 
structures developed in the health field, especially on enhanced health security in the EU, are 
key components of the CBRN action plan. 

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 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.  

B. In the field of civil protection the number of requests for intervention coordination in civil 
disaster  response  through  the  EU  Civil  Protection  Cooperation  Mechanism  is  growing.  The 
initiative will strengthen capacity in responding to health threats in a civil disaster situation. 

In the area of civil protection, the Commission adopted on 5 March 2008 a Communication 
on  reinforcing  the  Union's  disaster  response  capacity.154  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"155. EU co-operation in the 
field of civil protection aims to better protect people, their environment, property and cultural 

153 
154 
155 

COM(2009) 273 final 
COM(2008) 130 final 
COM(2010) 600 final 

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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. 

Examples are 

• 

• 
• 
• 
• 

transport  of  pharmaceuticals  and  medical  equipment  in  the  course  of  the  pandemic 
(2009) H1N1;  
refugees arriving on EU territory following turmoil in Northern African states;  
toxic spill of red aluminium sludge in Hungary;  
avian influenza infections;  
Cholera outbreak in Haiti, Dominican Republic, and danger to visitors.  

C. There are also possible synergies between the Health Security Initiative and EU activities 
in the field of external relations under the umbrella of the European External Action Service 
(EEAS).  

The  Health  Security  Initiative  will  appropriately  take  into  account  these  EU  external 
cooperation  activities  for  health  crises  prevention  and  responses  with  third  countries  and 
explore  synergies  with  the  numerous  bilateral  EU  assistance  and  cooperation  programmes 
with a significant health component.  

The  UN  Millenium  Development  Goals,  in  particular  Goals  4  (reduce  child  mortality  rates) 
and especially 6 (combat HIV/AIDS, malaria, tuberculosis and other diseases), are the basis 
for these activities; they are complemented by cooperation with third countries to mitigate the 
risk of CBRN materials or agents.  

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  Centres  of 
Excellence.  

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Annex 8: Business continuity and preparedness planning at EU and international level 

Whole-of-Society approach of the WHO and the Towards a Safer World Initiative 

The World Health Organization (WHO) has addressed the need for improved coordination of 
such critical sectors under the "whole society approach"156. This need has been emphasised by 
the United Nations 'Towards a Safer World' initiative157. 

In their paper the WHO notes that healthcare institutions depend on goods and services that 
are delivered by the following sectors: 

- transportation for the movement of supplies, personnel, and patients; 

-  telecommunications  to  support  patient  care,  provide  tele-triage,  and  maintain  business 
processing; 

- energy to power facility, clinical, and security systems; 

- water for healthcare facilities, pharmaceutical operations, and sanitation services; 

- pharmaceuticals, including consumables, for treatment of patients; and 

- finance to ensure the supply chain. 

The study under the UN 'Towards a Safer World' initiative on practical approaches to advance 
disaster  preparedness  published  in  September  2011  confirmed  that  multi-sector  action  plans 
often do not effectively reach community levels and cannot be implemented at local levels. In 
many  countries,  civil  society  organizations  are  not  sufficiently  consulted  and  engaged  in 
national  planning.  In  many  countries,  the  non-health  sectors  have  lagged  in  developing 
business  continuity  plans  and  are  not  prepared  for  the  disruption  of  supplies  and  services. 
Procurement  of  medical  countermeasures  is  an  essential  part  of  preparedness  planning.  The 
current situation seriously hampers proper preparedness across the EU when Member States 
procure medical countermeasures individually, i.e. in competition with each other, or do not 
even manage to procure them at all. 
Further studies on business continuity planning 
A study undertaken by the International Monetary Fund (IMF) in 2006158 found that in many 
countries, business continuity planning has not yet addressed the specific risks arising from a 
pandemic,  particularly  from  possible  high  absenteeism  and  that  the  level  of  preparedness 
among  national  authorities  and  financial  institutions  varies  greatly.  Several  large  global 
financial institutions have advanced preparations, as do providers of payment services, mainly 
by establishing alternative sites, and recovery task forces. Other authorities have progressed in 
identifying  the  critical  issues  in  handling  an  avian  flu  pandemic,  but  have  not  yet  finalized 
their  response  plans,  or  undertaken  all  the  necessary  steps  to  increase  resilience.  In  most  of 
these  cases,  decisions  over  significant  investments  (e.g.  in  IT  or  telecommunications 
infrastructure)  or  cross-training  of  staff  in  different  functions  have  yet  to  be  made,  and 
coordination with other private and public institutions is just beginning. 

156 

157 

158 

EN 

in 

the 

non 

health 

WHO,  Whole-of-society  pandemic  readiness  -  WHO  guidelines  for  pandemic  preparedness  and 
response 
on 
Sector,  Geneva, 
line:http://www.who.int/influenza/preparedness/pandemic/2009-
0808_wos_pandemic_readiness_final.pdf. 
Towards  a  safer  world:  Beyond  Pandemics:  A  Whole-of-Society  Approach  to  Disaster  Preparedness: 
http://www.towardsasaferworld.org/sites/default/files/tasw_book_web_9.23.pdf 
http://www.imf.org/external/pubs/ft/afp/2006/eng/022806.pdf 

available 

2009, 

July 

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A  seminar  on  pandemic  preparedness  planning  organised  under  the  French  presidency  in 
September 2008159 concluded that compared to the health sector other critical sectors are not 
as  well  prepared  to  address  a  pandemic  and  underlined  the  need  to  improve  inter-sectoral 
preparedness. 

A study carried out in 2008160 found huge gaps and differences across Europe in the level of 
advice given to businesses to prepare for a possible influenza pandemic. The report reviewed 
the advice offered by 13 independent advisory organisations and that of the governments of 
the 27 EU countries, as well as Turkey, Norway and Switzerland. The report concluded that 
the  advice  on  preparedness  given  to  businesses  in  the  non-health  sector  by  European 
governments and independent organisations, such as consultancy firms, academic bodies and 
trade  unions,  is  insufficient  to  ensure  that  the  private  sector  is  equipped  to  deal  with  a 
pandemic.  Over  a  third  of  all  governments  surveyed  offered  no  advice  at  all  and  only  8 
provided significant levels of advice. 

A work shop on inter-sectoral preparedness organised under the Spanish presidency in May 
2010  concluded  that  there  is  a  lack  of  data  on  the  level  of  preparedness  planning  in  critical 
sectors involved in the response to a pandemic.  

The European Centre for Disease Prevention and Control (ECDC) has facilitated systematic 
self assessments of pandemic preparedness in the Member States161. The results show that: 

• 

• 

• 

• 

• 

most EU Member States and countries of the European Economic Area (EEA) have 
health sector plans.  

many  countries  do  not  have  business  continuity  plans  to  maintain  essential  public 
services  during  the  sustained  stress  of  a  pandemic  (e.g.  transport,  utilities,  police, 
etc).  

only  40%  have  national  contingency  plans  for  maintenance  of  non-health  essential 
services, such as power supply, food distribution, etc, publicly available. 

79%  have  cross-sectoral  national  planning  structures  for  pandemic  preparedness 
rather than just in the health sector. 

only  61%  have  in  place  cross-sectoral  mechanisms  for  coordinating  and  assessing 
preparedness below national level. 

Critical infrastructure 
On 8 December 2008 the Council adopted Directive 2008/114/EC162 on the identification and 
designation  of  European  Critical  Infrastructure  and  the  assessment  of  the  need  to  improve 
their protection. 

159 

160 
161 

162 

http://www.pandemie-
grippale.gouv.fr/IMG/pdf/PROPOSALS_OF_THE_EUROGRIPPE_SEMINAR.pdf 
http://www.lshtm.ac.uk/news/2008/pandemicfluprepare.html 
Technical Report Pandemic Influenza Preparedness in the E U/EEA: 
http://ecdc.europa.eu/en/publications/Publications/0712_TER_Pandemic_Influenza_Preparedness_in_E
U_EEA.pdf 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:345:0075:0082:EN:PDF 

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The  Directive  establishes  a  common  procedure  for  the  identification  and  designation  of 
European  Critical  Infrastructure  –  ECI  –in  two  identified  sectors:  transport  and  energy.  A 
critical infrastructure is defined as an asset, system or part thereof located in Member States 
which  is  essential  for  the  maintenance  of  vital  societal  functions,  health,  safety,  security, 
economic  or  social  well-being  of  people,  and  the  disruption  or  destruction  of  which  would 
have  a  significant  impact  in  a  Member  State  as  a  result  of  the  failure  to  maintain  those 
functions. 

Among the obligations put forward by the Directive, the following could be relevant from the 
aspect of pandemic preparedness planning for critical sectors: 

-  Each  Member  State  takes  forward  and  participates  in  the  identification  and  designation  of 
relevant ECI; 

- Designated ECI must implement an Operator Security Plan (OSP); 

-  Each  Member  State  performs  threat  assessments  concerning  specific  sub-sectors  in  which 
ECI have been identified on their territory; 

-  Each  Member  State  reports  to  the  Commission  on  the  types  of  threats,  vulnerabilities  and 
risks identified in each sub-sector in which ECI have been identified on their territory;  

Member States have provided reports  on  the  state of play to the Commission.  Based on the 
information  gathered  through  the  ECI  process,  the  Commission  performs  an  assessment  of 
whether  further  measures  are  needed  concerning  the  protection  of  ECI.  A  review  of  the 
directive is foreseen for 2013.  

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Annex 9: The Health Programmes at European level 

The existing policy in the field of communicable diseases has been financed through the first 
Public Health Programme (2003-2008) and the second Health Programme (2008-2013). 

With  the  health  programmes  DG  SANCO  has  supported  Member  States  in  their  efforts  to 
enhance  generic  public  health  preparedness  planning  and  has  ensured  that  cross  border 
aspects of public health emergencies have been taken into consideration. EU priorities in this 
area  have  been  the  he  prevention  and  control  of  existing  or  emerging  contagious  diseases; 
preparedness  for  health  emergencies  and  response  capacity  against  chemical,  biological, 
radio-nuclear (CBRN) threats/attacks. 

It is planned that for important elements of the initiative, specific actions will be supported by 
the future Health programme "Health for growth". There is a dedicated "objective 4" which 
will  develop  common  approaches  and  demonstrate  their  value  for  better  preparedness 
coordination  in  health  emergencies.  In  addition,  there  is  a  transversal  objective  on 
implementation  of  EU  legislation.  2-4  Million  €  per  year  are  envisaged  internally  for  these 
purposes. 

Below  some  examples  of  successful  preparedness  projects  which  have  been  funded  in  the 
past: 

– 

– 

– 

Laboratory network (EURONET P4): Biosafety Level-4 (P4) facilities, which allow 
the  containment  and  the  study  of  very  dangerous  biological  agents  (e.g.  smallpox, 
ebola) are very expensive to build and maintain and require a lot of expertise from 
very skilled staff, and very secure people. A cost effective and lower risk alternative 
to building new laboratories is to foster long-term sustainable collaborative networks 
between  those  laboratories  that  already  exist.  Unique  in  the  EU,  this  project 
facilitates cooperation between all the highest biosecurity laboratories in Europe. 

SIDARTHA  project:  As  a  health  threat  emerges,  there  can  be  significant  delays 
between  the  onset  of  an  epidemic  and  the  launch  of  an  appropriate  response  by 
services and authorities – costly in terms of money spent, time wasted and lives lost. 
Being able to know early that a health emergency situation has begun is crucial to be 
able to respond appropriately. Syndromic surveillance is one of the solutions. It seeks 
to use existing health data in real time to provide immediate analysis and feedback to 
those charged with the investigation and follow-up of potential outbreaks. 

The CARRA-NET (Chemical and Radiation Risk Assessment NETwork)  project is 
intended  to  help  to  develop  a  coordinated  and  robust  preparedness  and  response 
capacity  within  the  EU  Member  States  (MS)  in  order  to  effectively  respond  to 
chemical  and  radio  nuclear  incidents,  especially  those  of  cross-border  significance. 
The project addresses issues such as the timely detection, alerting and distribution of 
information  to  relevant  stakeholders,  the  need  to  develop  risk  assessment  and 
management  strategies,  the  integration  of  scientific  advice  in  the  management  of 
emergencies,  and  the  need  to  have  good  liaisons  systems  in  place  between  the 
Member States, the European Commission, the EU agencies as well as international 
organisations  and  third  countries,  to  ensure  mutual  information  on  measures 
envisaged and coordination of such measures. 

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– 

– 

– 

– 

SHIPSAN:  SHIPSAN  TRAINET  aims  to  both  facilitate  the  implementation  of 
International  Health  Regulations  to  enhance  the  common  EU  policy,  but  also  to 
create  a  common  European  framework  for  ship  sanitation  inspection,  surveillance 
and  the  control  of  outbreaks.  Their  work  is  expansive,  covering  guidelines  for 
inspections,  food  safety  and  hygiene,  surveillance  of  communicable  diseases, 
medical facilities, outbreak plans, pest and waste. 

EpiSouth-Plus: EpiSouth-Plus is unique among projects funded by the EU and other 
international  initiatives  in  the  field  of  health  preparedness  in  its  focus  on  the 
Mediterranean  region  as  a  whole,  including  non-UE  countries  as  well  as  all  three 
WHO  Regional  Offices  that  cover  the  Mediterranean.  In  addition  to  facilitating 
epidemiological  communication  and  practical  training,  this  regional  approach 
strengthens  solidarity  and  cohesion  within  the  European  Community  and  between 
EU and non-EU countries, especially for information sharing regarding cross-border 
public health threats and for the implementation of the IHR, which have among their 
challenges  that  of  interacting  with  national  procedures  and  legislations  and  that  of 
facilitating a common international action in case of need. Moreover, it is expected to 
reduce the disparities in the different approaches to early warning and preparedness 
by  bringing  together  EU  and  non-EU  countries  in  all  the  planned  activities. 
EpiSouth-Plus will fill the gaps and needs that were identified in the previous years. 
In  particular,  the  laboratories  in  the  Mediterranean  region  will  be  better  connected 
and  coordinated  to  ensure  the  development  of  cross-border  laboratory  services, 
enhance  complementarity  among  vertical  and  fragmented  laboratory  networks  and 
help to overcome of national logistic and legislation constraints. Common procedures 
in interoperable Generic Preparedness and Risk Management Plans will be promoted 
to  reduce  inter-country  variability,  enhance  capacity  building  and  cross-border 
concerted actions and facilitate the elaboration of national plans and communication 
strategies.  

ASHT:  Large  contamination  events  of  hazardous  chemicals  require  a  rapid  alert 
system in order to trigger a rapid and appropriate response, to protect the health of 
potential  victims  of  the  deliberate  as  well  as  accidental  release  of  poisons,  which 
unlike viral or bacterial agents, can harm and kill very quickly. ASHT projects have 
now developed the concept of the Rapid Alert System for Chemical Health Threats 
(RAS-CHEM), which now includes a risk assessment tier for poison control centres 
to share information, and a risk management tier for national authorities and health 
ministries to escalate information to the EU. RAS-CHEM is an early warning system 
for DG SANCO. Member States now have a common platform to share information 
and  act  together  regarding  chemical  incidents  that  could  cross  borders  and  affect 
citizens throughout the European Union.  

ORCHIDS:  In  the  event  of  a  release  of  a  hazardous  substance,  large  numbers  of 
people will need to be decontaminated quickly – and effectively – so as to halt the 
spread  of  contamination  and  prevent  further  harm,  as  well  as  to  prevent  the 
contamination  of  emergency  responders  and  hospital  facilities.  Infrastructures, 
protocols and guidelines exist worldwide for the response to such incidents – such as 
the  deliberate  release  of  chemical  agents  on  public  transport  systems,  or  the 
emergency response to an industrial accident – but very little empirical evaluation of 
these  has  been  completed  to  date.  For  the  first  time,  an  EC-funded  scheme,  the 
Optimisation  through  Research  of  Chemical  Incident  Decontamination  Systems 
(ORCHIDS) project, is exploring ways to optimise mass casualty decontamination 

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Annex 10: Overview of Objectives of the Health Security Initiative 

general objectives 

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 

to reinforce the response to all serious cross-border threats to health based on a comprehensive and coherent approach to preparedness and response planning, risk monitoring and 
assessment as well as risk management including risk communication 

preparedness and response planning 

risk monitoring and assessment 

risk management and crisis communication 

specific objectives 

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 including improving equitable access to 
medical countermeasures 

identification 

to create conditions to ensure a coherent and 
and 
comprehensive 
notification  of  health  threats  and  evaluation 
of their risks to health, especially in case of 
health-related crises with a multidisciplinary 
dimension 

-  to  create  conditions  to  strengthen  and  enhance  coordination 
between  Member  States,  international  level  and  the  Commission 
in  order  to  ensure  a  coherent  and  consistent  policy  approach  to 
effectively  manage  responses  to  serious  cross-border  threats  to 
health across the EU 
-  to  create  and  facilitate  shared  and  coordinated  communication 
strategies  in  order  to  avoid  conflicting  or  inaccurate  messages 
being released to the public 

operational objectives 

preparedness and response planning 

risk monitoring and risk assessment 

risk management and crisis communication 

 - to develop and update comparable and coherent generic 
preparedness and response planning and planning for specific 
threats at EU level, in particular for pandemic influenza 
-  to  develop  and  agree  shared  standards  and  tailor-made  EU 
criteria  for  notification  of  threats  in  order  to  ensure  stronger, 
continued  and  resilient  operation  of  the  public  health  sector  in 
the  European  Union  based  on  the  requirements  set  out  by  the 
International Health Regulations  
- to create an instrument to improve equitable access to medical 
countermeasures, e.g. through a joint procurement mechanism 

-  to  strengthen,  better  interlink  and  ensure 
sustainability  of  existing  monitoring  and 
notification mechanisms and structures 
-  to  strengthen  and  create  capacities  for 
robust,  reliable,  and  rapid  public  health  risk 
assessment 
-  to  provide  mechanisms  for  reinforced 
coordination  among  existing  structures  for 
serious cross-border health threats other than 
communicable diseases 

-  to  strengthen  the  capacities  and  processes  and  provide  for  a 
sustainable structure for coordination of the public health response 
at EU level for any cross-border public health crisis 
- to clearly define the scope of activities of this structure/body and 
equip  it  with  a  strong  mandate  for  EU  risk  management,  with  a 
strong commitment of Member States 
- to strengthen actions related to risk and crisis communication on 
health  threats,  and  allow  for  rapid  exchange  and  agreement  on 
communication messages and strategies 

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 Annex 11: Notification of serious cross border health threats to the WHO under IHR 

Number of IHR events/ notifications by type of event and year during 15 June 2007 - 30 July 2011 

June- Dec  

2007 

4 

7 

2 

Type of event 

Animal 

Chemical 

Food Safety 

Infectious 

Product 

Undetermined 

Grand Total 

13 

2008 

2009 

2010 

Jan-July  

2011 

Grand Total 

1 

1 

12 

2 

16 

3 

3 

90 

1 

97 

1 

3 

43 

47 

1 

25 

1 

27 

4 

1 

12 

177 

5 

1 

200 

Communicable diseases notified under IHR are 177, Communicable diseases notified under 2119/98/EC through EWRS are 785; so 785: 177 = 4,5. 

That finally means that the events reported through EWRS under the EWRS criteria are 4,5 times more than the events reported under the IHR under 
the IHR reporting criteria. This is obvious because the criteria are different. This finally confirms that the EU criteria for reporting of communicable 
diseases are matching more event than the IHR. 

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Annex 12: Problems and public health consequences 

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Annex 13: Overview of measures proposed under the three options  

Option 1: Status quo:  

Option 2: Soft instruments  

Preparedness and 
response planning 

Follow up of implementation of 
guidance on preparedness;  
organise exercises and training; 
exchange best practice; 

Procurement of 
medical 
countermeasures 

Risk monitoring 
and assessment 

Support for Member States, e.g. 
in preparing tender 
specifications; 
promote production capacity for 
pandemic influenza vaccines;  

No strengthening of existing 
notification and monitoring 
mechanisms and structures; 
risk assessment on the basis of 
ad hoc support networks 

Risk management 

Maintain current informal 
mandate of the Health Security 
Committee (HSC) 

Shared approach on preparedness 
planning,  
identify core capacity standards related to 
IHR requirements; 
guidance on improved cross-sectoral 
preparedness and interoperability, 

Ditto option 1, plus:  
increase support for Innovative Medicines 
Initiative and/or EU stockpile of medical 
countermeasures,  
better exchange of information on 
contractual conditions ; 
Recommendation to MS to notify threats 
with tailor-made EU criteria; 
improve coordination for risk monitoring 
and assessment by informal 
arrangements; 
develop Memoranda of Agreement with 
entities dealing with alert systems; 
Replace HSC by expert group;  

Risk and crisis 
communication 

Informal HSC communicators' 
network to continue to facilitate 
exchange of information  

Develop EU coordination related to 
shared communication approaches and 
guidelines ; 

Option 3: Establish common EU legal framework covering all serious 
cross-border threats to health  
Common EU framework for MS to: 
- put in place common elements of preparedness planning; 
- report regularly on implementation of preparedness plans;  
- cooperate in cross-sectoral preparedness and response planning  
- implement requirements on common minimum core capacity standards;  
- agree and implement EU tailor-made criteria for notification of serious 
cross-border health threats at EU level;. 
Establish legal basis for EU coordination of joint action for purchasing 
medical countermeasures; 

Put in place coordination mechanism to notify at EU level cases of 
serious cross-border threats to health;  
require MS to notify the EU level in all cases relevant to IHR; 
close gaps in public health risk assessment capacities; 
Commission to support this by mapping existing risk assessments in 
order to improve coherence at EU level (linked to SG initiative on overall 
threat assessment);  
Improve coherence and coordination of risk management; 
EU action to cover advisory activities on preparedness and response 
planning and public health response coordination, non legislative acts 
and mutual agreements between MS;  
establish new instrument for joint actions, in particular joint procurement 
of medical countermeasures; 
Develop common communication strategies, integrate communicators 
into crisis management process and link communicators directly to risk 
managers / decision makers;  

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Annex 14: Opinions of stakeholders on the three options 

The  views  of  the  stakeholders,  as  gathered  through  the  consultation,  support  the  following 
actions  as  described  in  option  1:  the  view  that  the  EU  should  play  a  central  role  in 
encouraging national preparedness planning is supported by 93% of all the respondents. The 
same  opinion  was  clearly  expressed 
the  2010  consultation  on  pandemic 
through 
preparedness, where 98% of all respondents took the view that improved cooperation at EU 
level would enhance preparedness. 94% of all respondents also thought that it was important 
for countries' preparedness planning to work well with other countries in the EU. 90% of all 
respondents felt that the interoperability of Member States plans should be facilitated at EU 
level. 

In addition to the points mentioned under option 1, the views of the stakeholders, support the 
following actions, as described in option 2: minimum core capacity standards should be set up 
on  preparedness  planning  to  cover  more  public  health  aspects  resulting  from  chemical,  and 
environmental threats.  

According to 90% of the stakeholders the EU should coordinate national preparedness plans, 
for  example  by  providing  a  framework  to  improve  the  interoperability  of  national 
preparedness  plans.  In  the  2010  consultation  on  pandemic  preparedness,  92%  of  all 
respondents and 91% of those responding on behalf of a public authority felt there was a need 
for  the  European  Commission  to  take  a  coordinating  role  when  a  cross-border  aspect  was 
involved. 

The majority of the stakeholders (90%) are in favour of a better evaluation of public health 
issues resulting from all serious cross-border threats. 

The  stakeholders,  as  well  as  the  members  of  the  HSC  and  the  EWRS  network  committee, 
considered that a legal formalisation of the status of the HSC would be better. 

A  large  majority  of  the  stakeholders  (over  93%)  suggested  that  a  better  coordination  of 
information and communication between Member States could be made possible at EU level 
by: 

a. making risk and crisis communication an integral part of risk management at EU level; 

b. providing more guidelines on risk and crisis communication at EU level;  

c.  supporting  the  communication  efforts  of  Member  States  and  other  bodies  dealing  with 
health measures;  

d. establishing networks and improving communication with healthcare professionals; 

e. improving communication with the media; 

f. improving the consistency of communications between Member States. 

In addition to the points mentioned under options 1 and 2, the views of the stakeholders, as 
gathered through the consultation, support the following actions, as described in option 3: it is 
important,  according  to  the  members  of  the  HSC  and  EWRS  network  committee,  to  ensure 
interoperability  of  the  alert/notification  systems,  in  order  to  avoid  a  wide  range  of  differing 

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responsibilities to make announcements. The EWRS could be considered for this purpose. In 
the  same  way,  84%  of  the  stakeholders  consider  that  the  existing  detection  and  notification 
systems for health aspects at EU and national level should be better interconnected across the 
sectors in order to link the different disciplines (food safety, energy, transport).  

92%  of  all  the  respondents  believe  that,  better  coordination  and  management  of  all  serious 
cross-border  health  threats  is  needed.  85%  of  all  the  respondents  believe  that  improved 
coordination  of  national  public  health  measures  (prevention,  diagnosis,  treatment,  control) 
among Member States is also needed in the event of a cross-border health threat. 79% of all 
respondents think that a coherent risk management mechanism for serious cross-border public 
health threats at EU level would create added value. 

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Annex 15: Detailed tasks and obligations for Member States and the Commission under 
option 3 – legal proposal 

The following aspects related to preparedness would be covered by the legal proposal:  

Member States 

- inform and consult each other, in liaison with the Commission, in order to coordinate their 
efforts  for  the  purpose  of  ensuring  an  adequate  coherence  of  national  preparedness  and 
response  planning  at  EU  level  in  respect  of  monitoring,  early  warning  of  and  combating 
serious cross-border threats to health. 

-  coordinate  among  themselves  actions  to  encourage  the  consistency,  interoperability  and 
multi-sectoral  aspects  of  preparedness  and  response  planning  at  national  level  for  the 
perspective of protection and improvement of human health, in particular in critical sectors of 
society. 

- for core capacity requirements for preparedness and response planning at national level, take 
into  account  international  standards  on  health  security,  in  particular  developed  in  the 
framework of the World Health Organisation 

The Commission  

- provides for the coordination of these actions at EU level in collaboration with the Member 
States. 

-  adopts  recommendations  directed  to  the  Member  States  on  minimum  core  capacity 
requirements  for  preparedness  and  response  planning,  including  technical  guidelines  for 
setting up generic and specific plans in critical sectors of the society. 

-  by  means  of  implementing  acts,  adopt  procedures  for  information,  consultation  and 
coordination  in  relation  to  preparedness  and  response  plans,  in  order  to  ensure  consistency, 
interoperability  and  multi-sectoral  aspects  of  national  plans  at  EU  level,  including  adequate 
coherence between specific national plans developed for the critical sectors of the society.  

In the area of risk assessment, the Commission: 

- will make available to the competent authorities of the Member States an assessment of the 
risks to public health carried out by an Agency of the European Union ; 

- will provide an assessment of the risks to public health, in collaboration with the competent 
authorities of the Member States, if a assessment is not available or not comprehensive or not 
consistent  with  another  assessment  carried  out  by  an  Agency  of  the  European  Union.  The 
assessments  will  be  based  on  objective  expertise  and  robust  scientific  evidence,  and  review 
key  research  to  identify  any  potential  health  impacts  that  the  given  threat  may  cause, 
determine the amount, duration, and pattern of exposure to the threat, assess the ability of the 
agent to cause illness or death and identify the vulnerable groups, estimate dose-related health 
effects that may lead to illness or death, develop models for the likely progression of spread 
and  disease  outcome  and  define  options  for  public  health  measures  and  assess  the  potential 
impacts of those options on the critical sectors of society. 

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Risk management 

Member  States  consult  each  other  in  liaison  with  the  Commission  in  order  to  coordinate 
national responses to serious cross-border threats to health , they consult Member States and 
the Commission on the nature, purpose and scope of intended measures and adopt them.  

The Commission will provide for the coordination of response to serious cross-border threats 
to health in collaboration with the Member States. 

Member States may, in conjunction with the Commission, conclude a joint action, relating to 
a  serious  cross-border  threat  to  health;  e.g.  declaration  of  public  health  emergency  at  EU 
level,  coordination  of  prevention  and  control  campaigns,  including  vaccination;  coordinated 
information  and  communication  initiative,  including  awareness  campaigns  as  appropriate; 
coordinated communication messages, joint procurement on medical countermeasures. 

When  concluding  a  joint  action,  the  Member  States  will  ensure  that  these  measures  are 
proportional and limited to the risks to public health caused by the serious cross-border threats 
to  health,  and  respect  the  responsibilities  of  the  Member  States  for  the  definition  of  their 
health policy and for the organization and delivery of health services and medical care. 

In duly justify cases, the Commission may, by means of implementing acts, adopts: 

(a) guidelines on protective and control measures to be taken on serious cross-border threats 
to health, in particular in public health emergency of international concern; 

(b) guidelines on communication with the public and on good practice for the public. 

The Health Security Committee would: 

(a) advise the Member States and the Commission, at the Member States' or the Commission's 
request,  on  policy,  strategy  and  technical  issues  relating  to  health  security  as  well  as  on 
Commission proposals in that field; 

(b) coordinate preparedness and response planning 

(c) coordinate public health response  

The committee may invite experts and observers to attend meetings and would meet at regular 
intervals and whenever the situation requires. 

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Annex 16: Description of actions proposed under the options and their implications for the health sector 

Option 1: Status quo: Maintaining the current level of activities  

Actions proposed under status quo 

Justification/Motivation of the rating and impact 

The  Commission  would  continue  the  technical 
level  work  with  the  Member  States:  updating 
implementation  of  existing 
and  ensuring 
guidance  as  regards  generic  and  pandemic 
preparedness.  Surveys  and  development  of 
indicators would be supported.  

Experience  leads  to  the  assumption  that  EU  planning  has  only  a  limited  impact  on  Member  States  (MS).  Given  the 
voluntary  nature  of  the  approach,  MS  are  not  obliged  to  take  on  board  EU  guidance.  There  is  no  overview  and 
knowledge  on  how  Member  States  use  information,  guidelines,  case  studies  and  results  of  exercises  to  improve  their 
national  planning  in  relation  to  each  other.  In  addition,  under  this  option,  there  would  be  no  sustainable  and 
comprehensive implementation of the findings and recommendations of the currently funded projects under the Health 
Programme. 

Organising exercises where public health crises 
are  simulated,  and  exchange  of  best  practice 
would continue. 

This option will not coordinate in a coherent way the implementation and sharing of core capacity requirements under 
the International Health Regulations in MS. Preparedness planning will remain as diversified as it is now and parallel 
and uncoordinated implementation of IHR requirements by Member States will not lead to any common baseline for EU 
preparedness. In a crisis situation, bilateral arrangements with WHO would prevail over EU coordination.  

notification 

Shared  standards  and  EU  tailor-made  criteria 
for 
ensure 
implementation  of  the  requirements  as  set  out 
in the IHR would not be addressed. 

order 

in 

to 

Related  to  specific  preparedness  planning  in  the  field  of  communicable  diseases,  where  the  ECDC  is  mandated  to 
provide guidance and advice to Member States and to the Commission, the differences and incompatibilities between 
MS  could  prevail  in  the  absence  of  a  robust  solution.  In  addition,  the  most  recent  overview  on  how  the  existing  EU 
pandemic preparedness plan (set out in a Commission Communication from 2005) has been used, indicates substantial 
areas  for  further  work  to  ensure  national  readiness  in  case  of  a  pandemic  [see  ECDC  reports  on  the  basis  of  country 
visits pre2009 for evidence163]. In this context, in its resolution of 8 March 2011, the European Parliament calls for the 
prevention plans established in the EU and its Member States for future influenza pandemics to be revised in order to 
gain in effectiveness and coherence and to make them sufficiently autonomous and flexible to be adopted as swiftly as 
possible and on case-by-case basis to the actual risk.164The EU state of preparedness will not improve under this option 
given  that  all  the  levers  remain  at  national  level  with  no  EU  power  to  implement  an  overall  coherent  and  consistent 
approach. For example, the evidence of a lack of a joint approach was demonstrated in the evaluation report on H1N1 
(2009) in paragraph. 7.2165 , where only seventeen MS report that consultation occurred between them and neighbouring 
European countries in the development of plans during the preparedness phase. 

163 
164 
165 

http://ecdc.europa.eu/en/publications/Publications/0701_TER_Pandemic_Influenza_Preparedness.pdf 
European Parliament resolution of 8 march 2011 on evaluation of the management of H1N1 influenza in 2009-2010 in the EU (2010/2153(INI)) 
http://ec.europa.eu/health/communicable_diseases/docs/assessment_response_en.pdf 

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improve  equitable  access 

to  medical 
To 
the  Commission  would 
countermeasures, 
continue 
States' 
cooperation,  e.g.  in  the  preparation  of  their 
national 
for  vaccine 
procurement.  

tender  specifications 

support  Member 

to 

improved  vaccination 

to 
The  Commission  would  also  continue 
promote improved production capacity, through 
e.g. 
for 
seasonal  flu  which  could  influence  capacity 
building 
influenza  vaccine 
production. 

for  pandemic 

coverage 

The situation in other critical sectors will not improve; the risk therefore remains that in a health crisis, critical sectors 
will  not  be  enough  prepared  for  health  consequences  of  a  serious  event.  This  may  lead  to  serious  consequences  as 
regards  capacities  of  the  health  system  to  respond  effectively.  (See  conclusions  of  French  presidency  conference 
Eurogrippe  2008:  "However,  the  results  of  this  preparedness  work  show  heterogeneity  among  Member  States.  It  is 
incomplete  in  the  public  health  sector,  but  even  more  so  in  other  sectors  (some  countries  need  to  take  further  into 
account an inter-sectoral dimension in their preparedness plans). Several priorities were identified as leading to critical 
distances, among which several are Inter-sectoral".)166 

The impact of option 1 would be low as the current systems would be maintained but not strengthened.  

Maintaining the status quo would mean that the access to medical countermeasures will be left in the responsibility of 
the Member States with no EU component to improve the purchasing power of the Member States and the contractual 
conditions  under  which  the  contracts  are  made.  It  will  also  not  ensure  that  risk  groups  are  covered  by  a  common 
approach  for  vaccination.  The  Commission  would  continue  to  play  an  assisting  role  to  help  Member  States  drafting 
technical specifications for national tenders, sharing best practices and expertise on tendering procedures, which could 
assist smaller Member States and those with less public procurement experience to improve the efficiency of the process 
at national level.  

However, in 2009 a similar effort by the Commission to provide such assistance during the H1N1 pandemic only met 
with  limited  success  with  a  maximum  of  5  Member  States  participating  in  the  exercise.  Nevertheless  this  effort 
confirmed the value of such EU intervention for the smaller Member States. Building on this experience, the Council 
subsequently called on the Commission in October 2009167 to continue to support procurement processes for the vaccine 
for those Member States, candidate countries, potential candidates and neighbouring countries who do not have a current 
agreement with manufacturers. The Council called on the same occasion to explore further the Commission initiative in 
2009 to create a virtual stockpile of pandemic influenza vaccines and antivirals (enabling sharing of surplus supply)168.  

The Commission would propose actions based on Council Recommendation of 22 December 2009 on seasonal influenza 
vaccination  (2009/1019/EU)  169  calling  upon  the  Member  States  to  increase seasonal  vaccination  coverage  of  the  risk 
groups up of 75% (currently only 11 Member States have a vaccination coverage for these groups higher than 50%170). 
This  process  is  intended  to  put  in  place  of  higher  level  of  production  capacity  for  vaccines  in  Europe  in  case  of  a 

166 
167 
168 
169 
170 

http://www.pandemie-grippale.gouv.fr/IMG/pdf/PROPOSALS_OF_THE_EUROGRIPPE_SEMINAR.pdf 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/110500.pdf 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/111599.pdf 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:348:0071:0072:EN:PDF 
http://www.eurosurveillance.org/images/dynamic/EE/V13N43/Venice_Survey_Figure2.jpg 

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The  EU  would  continue  to  work  with  the 
monitoring 
existing 
mechanisms 
without 
strengthening  coordination  among  concerned 
policy areas.  

notification 
and 

and 
structures 

Communicable  diseases  would  remain  under 
the existing legal framework. 

Risk assessment related to serious cross-border 
health  threats  arising  from  threats  caused  by 
biological  (other  than  communicable diseases), 
chemical,  and  environmental  related  events 
would  be  delivered  on  the  basis  of  ad  hoc 
support networks as it is the case now. 

Pandemic in order to improve their availability for citizens. However the implementation depends entirely on MS and it 
is the MS responsibility to review their vaccination strategies for seasonal flu.  

In  addition,  the  Commission  would  continue  to  support  through  the  EU  Research  and  Development  Framework 
Programme which encourages the development of pharmaceutical products171.  

As  a  consequence,  under  this  option,  the  Commission  would  continue  to  offer  limited  value  support  to  the  Member 
States  but  they  have  shown  during  the  Pandemic  H1N1  2009  (a  mild  pandemic)  very  modest  impact.  Therefore,  this 
option would not create an instrument to support access to medical countermeasures by the Member States.  

Under option 1,  coordination  among networks  and  mechanisms  in  place  would not  be  strengthened  and no  additional 
arrangements will be put in place to improve coordination. Alerts from rapid alert systems for other policies will not be 
notified systematically to the public health authorities for the purpose of risk monitoring and assessment and gaps in the 
notification of serious cross-border threats to health of chemical, biological or environmental origin would persist. The 
Commission would also not be notified of such threats through the IHR. The impact would be lack of specific requests 
to carry out a risk assessment from the public health perspective. This weakens the capacity of the EU to respond in the 
case of such health threats. For example, in a Member State exercise carried out in 2011, it was concluded that there was 
no linkage between major cross-border chemical events and the EU public health authorities leading to an absence of 
adequate  information  as  a  basis  for  a  coherent  response172.  In  addition,  real  life  situations  such  as  the  forest  fires  in 
Russia  and  the  volcanic  eruption  in  Iceland  demonstrated  that  there  was  no  tool  to  share  information  at  EU  level  on 
public health impact. Although there were strong concerns of public health impacts, happily these turned out not be the 
case.  

The use of incentive measures to link public health authorities in respect of risk monitoring for chemical, biological or 
environmental  related  threats  would  continue  under  the  Health  Programme.  However  the  value  of  such  initiatives  is 
modest as they are not linked to other policy areas, as the funding is not sustainable and since the experience has shown 
that the Member States are reluctant to use these unsustainable notification systems for regular reporting; disparities and 
incompleteness  of  reporting  would  be  the  consequences  which  might  lead  to  delayed  and  incoherent  response  in  the 
event  of  a  crisis.  In  addition  these  informal  public  health  systems  may  duplicate  other  reporting  systems  in  the  same 
fields based on legal requirements in those policy fields173.  

171 
172 
173 

EN 

http://ec.europa.eu/research/health/infectious-diseases/emerging-epidemics/fp7projects_en.html 
Exercise Iridium; http://ec.europa.eu/health/preparedness_response/docs/iridium_1_2011_frep_en.pdf 
eMars - http://emars.jrc.ec.europa.eu/; MIC - http://ec.europa.eu/echo/civil_protection/civil/prote/mic.htm; CleanSeanethttp://www.emsa.europa.eu/operations/marine-
pollution/cleanseanet.html; SEIS http://www.eea.europa.eu/about-us/what/shared-environmental-information-system 

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The mandate of the Health Security Committee 
under Council conclusions of 22 February 2007 
as prolonged by the Council Conclusions of 13 
September  2010,  would  be  maintained  and  the 
Council would be the EU institution to prolong 
its  mandate,  as  is  the  situation  currently.  The 
committee would remain an informal body and 
commitment  of  Member  States  would  be 
maintained on the same level as currently. 

As regards risk assessment, this option would continue to rely on networks whose expertise can be gathered on an ad 
hoc basis. This would not lead to strengthening capacities either in the short-term or long term and gaps would remain 
and may lead to inefficient and ineffective response.  

Option 1 may as it is now lead to inappropriate risk assessment and response. 

Under  this  option,  risk  management  will  continue  to  be  ensured  by  two  existing  structures,  one  legally  based  (and 
responsible  for  communicable  diseases174)  and  another  informal  entity  (the  Health  Security  Committee)  which  is 
intended  to  coordinate  public  health  response  mainly  for  other  health  related  threats,  but  with  functions  relating  to 
pandemic preparedness.  

In a crisis situation, the Health Security Committee can discuss public health measures to be implemented in the MS. 
However, these measures are at times difficult to agree and are not legally binding. An example was during the H1N1 
pandemic, when obtaining agreement in the Committee for joint statements on school closure, vaccination policy and 
travel advice175 was not easy to agree and the final statements were not uniformly implemented at member state level. 
However, since the committee was set up by the Council and is composed of high level representatives of ministers of 
health,  it has  a  political  and strategic  credibility  and responsibility  which goes  beyond  a  technical  level  committee.  It 
also has the advantage of allowing a cross sector approach acting as a focal point, which might be difficult to replicate in 
a more formal committee structure. 

As neither the mandate of the Health Security Committee nor the scope of measures which it could agree on would be 
changed  under  this  option,  there  would  be  no  impact  on  strengthening  its  role.  Furthermore,  the  current  overlap  of 
formal and informal structures, in particular in the area of pandemic preparedness, would persist. This was dealt with in 
2009 by holding joint audio conferences of both groups, but this did not resolve the issue of the mixed competences, 
different  conferral  of  powers  (one  could  vote  on  legal  measures,  the  other  not)  nor  the  fact  that  both  groups  have 
different memberships.  

In its resolution of 8 March 2011, the European Parliament requests clarification, and if necessary review, of the roles, 
duties, remits, limits, relationships and responsibilities of the key actors and structures at EU level for the management 

174 
175 

Early warning and response network, Decision 2119/98 (OJ L 268 3 10 1998, p.1) 
http://ec.europa.eu/health/archive/ph_threats/com/influenza/docs/hsc_ewrs_statement_en.pdfhttp://ec.europa.eu/health 
/archive/ph_threats/com/influenza/docs/statement_travel_en.pdf 
http://ec.europa.eu/health/archive/ph_threats/com/influenza/docs/statement_school_en.pdf 

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of  medical  threats.  It  welcomes  the  fact  that  the  Commission  has  committed  itself  to  studying  the  possibility  of  a 
revision and a long-term reinforcement of the legal basis of the Health Security Committee.176 

This option would  also  not address  the  current  absence of  a  legal  basis  under which  public  health measures  could  be 
coordinated in the Health Security Committee as regards serious cross-border health threats other than communicable 
disease. Therefore, for example, in case of a serious cross-border deliberate release of a biological agent (such as Ricin), 
the  EU  coordination  through  the  Health  Security  Committee  would  remain  as  it  is  at  present,  on  an  informal  and 
voluntary  basis.  There  would  continue  to  be  an  unbalanced  approach  between  the  communicable  disease  threat 
framework  and  that  for  other  threats,  one  being  legal  the  other  not.  This  is  illogical  and  unfortunate  since  the  public 
health  consequences  of  these  other  types  of  threats  (such  as  a  weapon  containing  pathogens  or  chemicals  (dirty 
bomb)177)  might  be  significantly  more  serious  than  traditional  threats  caused  by  communicable  diseases  (such  as 
Mumps178). Examples of the potential dangers of such events arose during the mustard gas stockpile event in 2011 in 
Libya during the current civil disturbance179, or the dispersal of Sarin gas in the metro in Japan in 1995180. 

The  informal  HSC  communicator's  network 
would  continue 
to  facilitate  exchange  of 
information in the event of a crisis and continue 
to provide guidelines on communication  

As basic parameters remain unchanged, no improvement in impact can be expected. Structures are not strengthened and 
conditions for communication will not be further improved. This would result in non implementation of "lessons learnt" 
from  the  evaluation  report  of  H1N1  in  2009  which  stressed  the  importance  of  improving  public  communication 
coordination at EU level for cross-border health threats. 

176 
177 
178 
179 
180 

European Parliament resolution of 8 march 2011 on evaluation of the management of H1N1 influenza in 2009-2010 in the EU (2010/2153(INI)) 
http://ec.europa.eu/home-affairs/summary/docs/com_2009_0273_en.pdf 
http://www.ecdc.europa.eu/en/healthtopics/mumps/Pages/index.aspx 
http://www.iss.europa.eu/uploads/media/The_return_of_the_Gaddafi_and_his_chemical_weapons_spec 
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(95)92170-2/abstract 

tre_01.pdf 

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

Actions  proposed  as  regards  different 
handling of serious cross-border to health to 
strengthen the current system  

The Commission would propose to the Member 
States  a  shared  approach  on  generic  and 
specific  preparedness  planning,  including  for 
pandemic  influenza.  This  approach  would  be 
non-binding  and  voluntary  for  the  Member 
States.  

include 

identification  of  core 
This  would 
to  surveillance, 
capacity  standards  related 
and 
verification, 
notification, 
response 
and 
activities  building  on 
collaboration 
strengthening requirements under IHR. 

on 

the  Commission  would  provide 
Finally, 
cross-sectoral 
improved 
guidance 
preparedness  and  interoperability  and  continue 
to encourage exchange of best practice through 
seminars  and workshops  and  provide  incentive 
measures via the Health programme  

Justification/Motivation of the rating and impact 

Under option 2, the Commission would develop guidance on generic and preparedness planning in cooperation with MS 
(for  instance,  Council  recommendations  under  Article  168.6  TFEU),  and  would  propose  shared  requirements  on  core 
capacity in line with the International Health Regulations. The approach would also include guidance for other crucial 
sectors of the economy and society, in particular for preparedness for pandemic influenza in line with the "whole society 
approach" of the World Health Organisation and the Treaty provisions on "health in all policies" in Article 9 TFEU. This 
approach  would  bring  more  consistency  and  compatibility  in  preparedness  at  EU  level  and  across  sectors  because  it 
would move from the current voluntary and informal approach under the baseline and option 1 scenario, towards a more 
formalised approach with reporting requirements. In addition, criteria for notification as set out in the IHR181 would be 
adapted for EU requirements in order to ensure that all serious cross-border health threats would be notified (please refer 
to the part for Risk monitoring and assessment for additional information). 

Member  States  would  be  encouraged  to  implement  Council  recommendations  following  the  outcomes  of  regular 
evaluation  of  their  implementation,  which would  increase  impact  at  national  level,  even  if  it  is  not  binding.  There are 
many  examples  where  such  recommendations  have  had  a  measurable  impact  on  Member  States  policy  making  (eg. 
dealing with health care associated infection, seasonal flu vaccination and anti microbial resistance).182 

In  addition,  the  Commission  would  continue  to  encourage  exchange  of  best  practice  and  provide  incentive  measures, 
using the EU health programme as is currently the case. This would lead to better dissemination of data and probably 
even  trigger  innovative  aspects  but  sustainability  cannot  be  expected  given  that  these  activities  are  carried  out  using 
project grants of limited duration. 

Under  this  option,  the  objective  can  be  partially  addressed.  If  Member  States  contribute  to  guidance  and  implement 
accordingly  on  the  basis  of  a  soft  instrument  such  as  a  Council  Recommendation,  there  is  an  improvement  of  the 
preparedness situation as common indicators and arrangements can be put in place, and as progress can be monitored and 
reported  on  by  the  Commission.  Smaller  Member  States  will  probably  benefit  more  than  bigger  countries  which  have 

http://www.who.int/ihr/annex_2_guidance/en/index.html 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:348:0071:0072:EN:PDF; http://ec.europa.eu/health/patient_safety/docs/council_2009_en.pdf; http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:034:0013:0016:EN:PDF 

87 

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182 

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In order to improve equitable access to medical 
countermeasures, 
could 
continue, as described in option 1,  

the  Commission 

- to take incentive measures relating to capacity 
building for vaccine production, and  

-  to  play  a  supporting  role  to  Member  States 
cooperation,  e.g.  in  the  preparation  of  their 
national tender specifications.  

In addition, as part of Option 2, 

incentives  related  to  the  Innovative  Medicines 
Initiatives  or/and  EU  stockpile  of  medical 
countermeasures 

could 

strengthen 

The  Commission 
the 
purchasing  power of  the  MS  by  improving  the 
exchange  of 
information  on  contractual 
conditions  through  the  confidential  platform 
CIRCA BC.  

more resources for preparedness planning and more developed cross-sector crisis management structures. 

Under this option, the initiatives proposed in Option 1 above would be implemented as a baseline.  

In  addition  to  the  financial  measures  improving  capacity  building  that  are  envisaged  under  option  1,  the  Commission 
may  envisage  under  option  2  to  use  the  Innovative  Medicines  Initiative183,  Europe's  largest  public-private  initiative 
aiming to speed up the development of better and safer medicines for patients. However, these incentives will only cover 
activities  related  to  research  and  development  and  not  directly  contribute  to  improve  the  availability  of  medical 
countermeasures on the short term and therefore only partially address the objectives.  

Furthermore, the setting up of stockpile of medical countermeasures could also be envisaged under this option to increase 
equitable  access  to  medical  countermeasures;  however  the  Commission  has  already  proposed  such  initiative  and  was 
withdrawn following political opposition from the Council in 2006 on grounds of subsidiary and costs184. In other regions 
and countries similar initiatives have however been implemented. 2 regional stockpiles of medical countermeasures for 
South  East  Asia  were  funded  through  the  Japanese  Government  over  a  5  year  period  for  a  budget  of  48M$185. 
Alternatively,  the  Swiss  Government  has  a  legislation  obliging  the  producers  to  create  a  stockpile  of  essential  goods 
(incl. antivirals) with marginal costs to the Government186.  

Regarding equitable access to medical countermeasures, the Commission could play a supporting role to Member States 
by facilitating cooperation in the preparation of the tender specifications and, following a bundle of individual calls for 
tender launched simultaneously, cooperate in the evaluation of tenders and the award of national contracts.  

This  impact  of  this  option  is  expected  to  be  an  improvement  over  individual  national  procurement  mechanisms  and 
compared  to  the  limited  assistance  provided  during  the  influenza  H1N1  (2009)  pandemic  which  was  restricted  to 
working  on  the  drafting  of  national  tender  specifications.  It  allows  pooling  the  expertise  of  the  Member  States  and 
improves  transparency.  The  value  of  previous  efforts  at  the  European  level  in  the  field  of  procurement  of  medical 
countermeasures  was  recognised  in  Council  Conclusions  in  2009187  and  2010188  which  extended  requests  to  the 

183 
184 
185 
186 
187 

http://www.imi.europa.eu/ 
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/06/732&format=PDF&aged=1&language=EN&guiLanguage=fr 
http://www.flu.mn/mgl/images/stories/Sudalgaa_shinjilgee/WPRO2011_pdm/10%20ASEAN%20ASEF%20Stockpile%20Project_JICS_Beijing_Mar2011.pdf 
http://www.bwl.admin.ch/themen/01009/01025/index.html?lang=en 
"To ensure timely availability of vaccines for all Member States, the possibility of a mechanism or a bundle of tender notices should be considered by those Member States 
with no current or with partial agreements with manufacturers as the most efficient way to proceed." "Invites the Commission to continue to support procurement processes 
for the vaccine for those Member States, candidate 
manufacturers;"http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/110500.pdf 

countries, potential candidates and neighbouring countries who do not have a current agreement with 

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Commission to develop it further. In addition, in its resolution of 8 March 2011, the European Parliament expresses its 
approval  for  the  introduction  of  a  procedure  enabling  Member  States  to  make  purchases  of  vaccines  and  medical 
products on a voluntary basis, in order to obtain, for a given product, inter alia, equitable access, advantageous rates and 
flexibility  for  the  order.189  However,  the  current  option  remains  at  the  level  of  cooperation  between  individual 
procurements  and  the  purchasing  power  and  ability  to  obtain  better  contractual  conditions  will  remain  much  weaker 
compared to the option of a full joint procurement, as proposed under Option 3.  

It  would  not  guarantee  implementation  of  the  Council's  own  political  commitment  in  the  same  conclusions  to  "ensure 
timely availability of vaccines for all Member States". 

Also, it would not ensure a joint procurement mechanism as requested by the Council in Conclusions in 2010 "Inviting 
the Commission to report on and develop […] a mechanism for joint procurement of vaccines and antiviral medication 
which  allows  Member  States,  on  a  voluntary  basis,  common  acquisition  of  these  products  or  common  approaches  to 
contract  negotiations  with  the  industry,  clearly  addressing  issues  such  as  liability,  availability  and  price  of  medicinal 
products as well as confidentiality"190. 

As regards notification of threats other than 
those caused by communicable diseases a 
proposal/recommendation to Member States 
would be issued to mutually notify each other 
and the Commission of health threats with 
tailor-made criteria required because of the 
integrated nature of the EU. 

Risk  monitoring  and  risk  assessment  for  other 
serious  cross-border  threats  to  health  would 
rely  on  improved  coordination  by  providing 
informal  arrangements  among  existing  EU 
structures,  such  as  EU  agencies  or  informal 

Under this option, notification will be strengthened and knowledge from other rapid alert systems will be improved and 
agreements  for  mutual  alerting  will  be  established  at  EU  level.  At  present  this  exchange  of  information  between  the 
different alert systems is informal, not systematic and depends on the individual awareness of the potential cross-sectoral 
aspects of an event by the responsible officers191. For example, communicable diseases (West Nile virus, Chikungunya, 
Q  fever,  etc.)  with  impact  on  blood,  organs  and  tissues'  safety,  have  triggered  such  internal  informal  communication. 
This mutual notification from one system to another allows risk assessment in full knowledge of all aspects of the alert 
and a coordinated response among sectors. The impact of a more robust system will be that public health authorities will 
be informed earlier when alerts are notified through other EU alert systems and vice versa and define at an earlier stage 
whether the notified events would constitute a serious cross-border threat to health. 

This option would also address the current problem that threats other than communicable diseases are notified to WHO 
through the IHR without informing the EU. Under this option, notification would be linked to IHR and tailor-made EU 
criteria will be developed at EU level. For instance at the moment, there is a ratio of almost 5 to 1192 between the alerts 
notified to the EU for communicable diseases (in 27 Member States) and those notified to the IHR for the same diseases 

188 
189 
190 
191 

192 

http://ec.europa.eu/health/preparedness_response/docs/council_lessonsh1n1_en.pdf 
European Parliament resolution of 8 march 2011 on evaluation of the management of H1N1 influenza in 2009-2010 in the EU (2010/2153(INI)) 
http://ec.europa.eu/health/preparedness_response/docs/council_lessonsh1n1_en.pdf 
Currently  messages  from  the  ECURIE  system  dealing  with  radiological  events  are  transmitted  by  fax  and  therefore  may  not  be  transmitted  to  the  right  responsible 
authorities of DG SANCO. 
http://www.who.int/csr/don/archive/year/en/index.html 

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networks currently in place. 

groups  (in  194  WHO  States  Parties).  The  EU  needs  to  have  tailor-made  criteria  for  notification  for  threats  since  IHR 
criteria  apply  worldwide  and  are  not  adapted  to  the  fundamental  freedoms  of  the  EU  such  as  the  principle  of  free 
movement193. For example the contamination of milk from China with melamine which had not been notified through the 
IHR despite the fact that the contaminated product was circulating worldwide and was affecting the health of children194. 
An  other  example  was  in  2009  when  there  was  some  delay  by  WHO  declaring  a  pandemic  for  H1N1.  As  a  result, 
because  of  the  linkage  with  the  EU  pharmaceutical  legislation,  production  of  pandemic  vaccines  could  not  begin195. 
Overall under this option notification of threats would be improved; however, be based only on recommendations. 

In order to have a rapid, coherent and comprehensive public health risk assessment, pre-established internal agreements 
between  the  Commission  services,  EU  Agencies  and  existing  networks  of  Member  States  experts  providing  scientific 
expertise  to  cooperate  in  a  crisis  would  be  of  advantage,  and  standard  operating  procedures  on  information  exchange 
would be established. The inventory of existing networks relevant to deliver expertise would be regularly updated which 
includes information on structures, networks and contact details both in Member States and at EU level so that in case of 
a  crisis  expertise  could  be  collected  within  a  relatively  short  time  period.  For  instance  a  model  for  such  an  approach 
would be the network established in the chemical sector already set up by the Commission under the Health Programme 
and which links public health authorities with responsibilities in the chemical sectors (80 poisons centres in the EU) in 
order  to  share  expertise  and  risk  assessment  through  a  rapid  alert  system  (RAS  Chem196)197.  In  addition  a  package  of 
exercises (Iridium 1, 2 and 3) are being undertaken to test the operational level of the network for chemicals. 

This  option  would,  even  if  build  on  recommendations,  significantly  strengthen  risk  assessment  capacities  in  short  and 
long term and create a strong basis to respond to serious cross-border threat to health. 

The  Health  Security  Committee198  would  be 
abolished  in  its  current  form  and  would  be 
formalised  as  a  Commission  expert  group.  Its 
mandate  would  be  reviewed  and  limited  to 
coordination  of  preparedness,  notification  of 
measures  implemented  at  national  level  and 
coordination  of  response  for  serious  cross-

Under option 2, the Health Security Committee would be replaced by a new expert group under the Commission remit. 
Its  mandate  would focus on other  serious  cross-border health  threats.  The  impact  of  this option would be  to have  two 
distinct expert groups. The Early Warning and Response System Network would continue to coordinate response in case 
of a serious cross-border threat due to communicable diseases. The new expert group would ensure this coordination for 
other threats. The advantage would be that responsibilities and scope would be clarified, mandates clearly distinguished 
and  duplication,  as  described  in  option  1  in  respect  of  pandemic  preparedness  and  coordination  of  response  to 
communicable diseases, avoided. Secondly, clarification of roles would mean that risk management would be carried out 

193 
194 
195 
196 
197 
198 

http://ec.europa.eu/consumers/safety/rapex/index_en.htm + http://ec.europa.eu/food/food/rapidalert/index_en.htm 
http://www.eurosurveillance.org/images/dynamic/EE/V13N40/art18998.pdf 
http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html 
http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1247728923224 
CARRA NET Draft final report, Framework Service Contract No 2009 61 05 Lot 2 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf 

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than 

border  threats  to  health  caused  by  biological 
diseases199), 
communicable 
(other 
chemical, environmental or events of unknown 
origin.  No  binding  requirements  would  be 
foreseen for Member States under this option. 

As  regards  risk  and  crisis  communication 
aspects,  Member  States,  in  liaison  with  the 
Commission, 
shared 
communication  approaches  and  guidelines  e.g. 
sharing best practice in approaching the media.  

develop 

would 

by the appropriate experts in the appropriate setting. 

As a result of this option, the Commission would be able to recommend measures for risk management to Member States 
based  on  the  expertise  of  the  new  expert  group.  Although  this  will  increase  the  sustainability  of  risk  management  for 
other  threats  coordination  we  will  still  have  a  weaker  approach  for  threats  other  than  communicable  diseases,  as 
measures will remain non binding for the first and binding for the second. As the former Health Security Committee will 
be become a Commission advisory group instead of a Council establish group, it will not have the same strategic status 
and role as at present. 

Under this option, as the former Health Security Committee Communicators' Network will be part of a new expert group, 
the Commission could recommend messages to Member States and, shared communication approaches.  

Under  the  lessons  learned  on  the  2009  pandemic,  the  Commission  evaluation  report200  as  well  as  the  European 
Parliament report201 placed particular stress on coordination and streamlining of communication as a vital component of 
risk management. This was most recently demonstrated during the E. coli STEC O104 outbreak in Germany, where the 
importance  of  communication  on  a  public  health  threat  was  confirmed202,203.  This  option  would  provide  the  Member 
States  a  more  robust  base  to  commit  themselves  to  provide  a  common  shared  message  to  the  media.  As,  based  on 
experience in the past, Member States204 are keen to agree on common procedure and content that are more formalised205. 
This option would have a more significant impact that the actions foreseen under option 1. 

199 
200 

201 
202 

203 
204 

205 

The issue of preparedness and coordination measures regarding pandemic influenza would fall under the structures established by Decision n° 2119/98/EC. 
http://ec.europa.eu/health/communicable_diseases/docs/assessment_vaccine_en.pdf (TOR 2) chapter 6 p.81 and 
http://ec.europa.eu/health/communicable_diseases/docs/assessment_response_en.pdf (TOR 1) chapter 12 p.51 
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2011-0077&language=EN&ring=A7-2011-0035 
http://www.consilium.europa.eu/ueDocs/cms_Data/docs/pressData/fr/agricult/123823.pdf En ce qui concerne le système d'alerte rapide, certains États membres ont relevé 
que  la  communication  et  la  coordination  devraient  être  améliorées  afin  d'éviter  de  telles  répercussions  catastrophiques  sur  le marché.  La  plupart  des  États  membres  ont 
demandé qu'une campagne de promotion soit rapidement engagée au niveau de l'UE afin de rétablir la confiance à l'égard du secteur des fruits et légumes. 
http://www.europarl.europa.eu/en/pressroom/content/20110601IPR20702/html/E.-coli-outbreak-lessons-to-be-learnt-for-the-future 
see para 17; Council conclusions on Lessons learned from the A/H1N1 pandemic – Health security in the European Union 
(http://www.consilium.europa.eu/uedocs/NewsWord/en/lsa/116478.doc) 
See paragraph 8 of the CSWP on the activities of the Health Security Committee during the period from November 2009 to December 20 
(http://ec.europa.eu/health/preparedness_response/docs/hsc_activities_2009-2010_en.pdf) 

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

Actions  proposed  under 
extended EU competence option  

integrated  approach; 

Justification/Motivation of the rating and impact 

Under  this  option  the  Member  States  would  be  obliged 
to  put  in  place  an  agreed  approach  on  generic  and 
specific  preparedness  planning,  including  for  pandemic 
influenza 
its 
implementation.  

regularly  on 

and  would 

report 

Member  States  would  consent  to  cooperate  in  cross-
sectoral  preparedness  and  response  planning  through 
establishment  of  guidelines  and 
the 
organisation  of  exchange  of  best  practices,  preparation 
of periodic monitoring and evaluation. 

indicators, 

Member  States  would  also  agree  to  implement  in  a 
complementary way and in particular on shared common 
minimum  core  capacity  standards  for  preparedness  and 
response (e.g. adequate human resources, designation of 
responsible  entity,  etc.).  Furthermore,  Member  States 
would agree to use tailor-made criteria for notification at 
EU  level  of  serious  cross-border  threats  to  health, 
including  events  which  may  constitute  public  health 
emergencies of international concern. 

Member  States  are  already  obliged  to  have  in  place  minimum  core  capacity  standards  for  surveillance  and  response 
(Articles 5 and 13 of the International Health Regulations) by 2016 at the latest. Under this option it is proposed that this 
implementation is done in a coordinated manner at EU level. This would be achieved by the creation of EU generic and 
specific preparedness plans which would have an obligatory nature. General criteria for core capacity for surveillance 
and response based on those set out in Annex 1 of the IHR206 would be incorporated in the EU legislation and further 
implementation ensured by non legislative acts. 

This  would  provide  in  particular  for  cross  sectoral  cooperation  to  reach  a  coherent  level  of  preparedness  against  the 
consequences of a serious cross-border health threat among essential services and across Member States. For example, it 
would be possible under this option by use of the IHR core standards to ensure overtime that key sectors of the economy 
and  the  society  would  be  ready  for  health  effects  arising  from  a  serious  cross-border  threat.  This  has  already  been 
demonstrated to exist in several Member States, for example UK207, France208 and Poland209. However, at present, the 
EU dimension (internal market / common policies aspects) is not addressed. 

Continuous monitoring of implementation of core capacity standards would be put in place at EU level, based on the 
regular reporting by Member States according to agreed indicators. 

The situation related to preparedness would be significantly improved over time and become much more coherent than 
under the current situation, based on shared and common standards. Secondly, this option would result in more complete 
reporting on serious cross-border threats than is the case at present. 

This option would best address the objectives for preparedness planning.  

In  principal  no  additional  burden  or  charges  are  foreseen  as  IHR  core  capacities  need  to  be  implemented  anyway. 

206 
207 
208 
209 

http://whqlibdoc.who.int/publications/2008/9789241580410_eng.pdf 
http://www.cabinetoffice.gov.uk/content/pandemic-flu 
See para 2.6. Continuité de la vie sociale et économique (http://www.pandemie-  grippale.gouv.fr/IMG/pdf/PLAN_PG_2009.pdf) 
See p.29-32 for pandemic (http://rcb.gov.pl/wp-content/uploads/2011/02/zagr_okres1.pdf) 

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However some non-substantial organisational expenses might be expected in order to achieve greater interoperability of 
sectors and greater coherence among MS.  

This  option  would  also  create  a  legal  basis  for  the 
setting up and management of mechanisms for the joint 
procurement  of  medical  countermeasures  within  the 
TFEU legal framework.  

In line with the lessons learnt from the Pandemic and the conclusions of national, EU and independent investigations on 
the management of the Pandemic H1N1 (2009)210, this option provides for a legal basis for a joint action for purchasing 
of  medical  countermeasures,  notably  pandemic  influenza  vaccines.  This  would  create  an  opportunity  to  set  up  and 
manage an EU mechanism for the joint procurement enabling Member States to participate on a voluntary basis.  

Joint  procurement  means  combining  the  procurement  of  two  or  more  contracting  authorities.  Studies  and  concrete 
examples have highlighted the very clear benefits for contracting authorities in engaging in a joint action211. 

The  potential  positive  public  health  impacts  of  the  development  of  such  mechanism  were  further  demonstrated  by 
previous similar initiatives developed in other countries and regions212. 

Based  on  the  above  mentioned  illustrations,  an  EU  mechanism  for  the  joint  procurement  of  medical  countermeasures 
will notably yield the following impacts: 

• 

• 

promotes solidarity by ensuring that participating countries have a minimum level of equitable access 
to medical countermeasures. 

better  pandemic  preparedness  by  putting  in  place  advance  purchase  agreements  through  framework 
contracts with suppliers. 

In the field of pandemic influenza vaccines, joint procurement will result in a more synchronised start of the vaccination 
campaigns in the participating countries. 

The advantages of a joint procurement will result in a more favourable public opinion reaction, and more confidence by 
the public. 

210 
211 
212 

Cour des Comptes, Sénat, Rivasi, TOR II, BE Presidency 
EC Green Public Procurement Training Toolkit – Joint Procurement Fact Sheet 
An  assessment  of  the  development  of  a  joint  procurement  of  pharmaceuticals  in  the  public  health  sector  in  Jordan  has  demonstrated  that  purchasing  through  the  joint 
procurement process achieved an estimated savings of 2.4% (increased to 8.9% when not considering one particular product which raw material price increased significantly 
during the period concerned). Based on these initial findings, applying a joint procurement system for pharmaceuticals in the public health sector in Jordan confirmed its 
potential to reduce expenditures for the purchase of medicines and provide treatment continuously throughout the year. 

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In addition, along with the potential actions identified in option 1 and 2 regarding increasing the availability of medical 
countermeasures,  a  joint  procurement  would  encourage  existing  and  potential  new  suppliers  to  develop  new  products 
through a long-term guaranteed contract213.  

This  option  will  therefore  be  the  only  one  to  achieve  the  objective  to  improve  availability  and  access  to  medical 
countermeasures by the Member States in case of a cross-border health threat.  

Mechanisms  and  structures  currently  in  place  for  risk 
monitoring  and  assessment  of  communicable  diseases 
will be maintained as they stand.  

The  monitoring  of  serious  cross-border  threats  to  health  would  remain  as  it  stands  and  would  continue  to  be  dealt 
separately among different policies as the surveillance is in principle already in place at EU level for various types of 
threats. 

A  coordination  system  would  be  put  in  place  and 
involved  Member  States  consent  to  notify  to  the  EU 
level,  cases  of  cross-border  threats  to  health  caused  by 
chemical,  biological  and  environmental  events  and  -  as 
already in the past - communicable diseases. 

In  parallel,  Member  States  would  be  obliged  to  notify 
the EU level in all cases where notifications are made to 
WHO under the International Health Regulations.  

In  case  the  ECDC  or  another  EU  Agency,  Member 
States or the Commission identify serious cross-border 
threats  to  health  either  on  the  basis  of  notification 
system  or  risk  monitoring,  a  risk  assessment  may  be 
performed through existing structures at EU or national 
levels  in  liaison  with  the  Commission,  depending  on 
the  EU  and  Member  States respective  competences  in 
the given field. The Commission would seek to provide 
for  a  coherent  and  comprehensive  public  health  risk 
assessment at EU level. 

In this option, the Member States will notify to an EU system cases of serious cross-border health threats arising from 
sources  other  than  communicable  disease.  These  notifications  will  be  based  on  EU  tailor-made  criteria  due  to  the 
integrated nature of the EU, the internal market and the many common policies, which depend on a common response to 
common threats. 

This option will  not  affect  or  replace  the  multitude of  existing  EU  alert systems  but  simply  provide a  mechanism  for 
identifying those alerts with public health significance. This could e.g. be done through existing electronic tools, such as 
RAS  CHEM, which  links  a network of  member  states  public  health  actors  in  the  field  of chemicals.  It  would  require 
continuing  support  by  the  EU  level  for  the  operation  and  development  of  this  tool  and  network,  through  financial 
instruments  such  as  the  EU health  Programme  and  continued support  by  member  states.  It  could  be  examined  on  the 
basis  of  need  whether  to  provide  specific  tools  for  other  threats  (biological  other  than  communicable  diseases, 
environmental and events of unknown origin), although the frequency and severity of such threats and the cost of new 
systems  would  guide  this  choice.  This  flexible  and  informal  approach  is  the  most  appropriate  because  these  events 
arising from causes other than communicable diseases are not regular and are less frequent than communicable disease 
events214, and therefore require a lower proportionate response at the EU level.  

In addition to the elements proposed under option 2, an obligation for Member States to report all threats notified under 
the International Health Regulations to the WHO, whether these arise from communicable diseases or from other causes, 
at EU level would be established. Reporting would be done by using existing EU tools. This is because the Regulations 
are  legally  binding,  and  it  is  appropriate  that  alerts  passed  on  an  obligatory  basis  to  the WHO  are  also  passed on  the 

213 
214 

EC Green Public Procurement Training Toolkit – Joint Procurement Fact Sheet 
See annex 11 

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Current  gaps  in  risk  assessment  would  be  covered  by 
additional capacities for scientific expertise. This work 
would  be  underpinned  by  associating 
relevant 
international agencies (e.g. WHO). 

same  obligatory  basis  to  the  EU  level.  This  has  already  been  achieved  through  legally  binding  provisions  for 
communicable diseases.215 

For risk monitoring and assessment, this option would entail support for networks of Member States experts, working 
together  with  relevant  Commission  services,  EU  agencies,  and  international  organisations.  This  is  done  currently 
through  projects  supported  under  the  EU  health  programme,  for  example  a  network  for  risk  assessment  on  chemical 
events (RAS CHEM)216, and would require continued investment to enable sustainability. A possible improvement could 
entail a framework contract allowing risk assessment support on an ad hoc basis when required, particularly to ensure 
quality control. This would ensure a capacity when needed for a robust, reliable and rapid public health risk assessment. 

This  option  building  on  existing  tools  is  sufficient  to  address  the  needs  for  notification,  monitoring  and  assessment. 
Establishing new instruments is not considered proportionate, nor required by the frequency of such events. The option 
would  however,  as  has  been  noted,  require  continued  investment  at  the  EU  level  and  at  national  level.  It  would  in 
conclusion address the objectives set out for risk monitoring and assessment under the present initiative to a satisfactory 
if not ideal level. 

As regards risk management, EU action would consist 
in  ensuring  that  public  health  response  by  Member 
States to a serious cross-border health threat is done on 
a coherent and coordinated basis. 

This  involves  defining  the  notion  of  "serious  cross-
border  threats  to  health"  covered  by  the  new  regime 
(communicable  diseases,  biological  threats  other  than 
communicable  diseases,  chemical  and  environmental 
related threats and threats of unknown origin).  

On  this  basis,  the  relevant  criteria  for  notification  of 
such threats would be specified and the conditions and 
rules  would  be  laid  down  in  a  way  that  a  coordinated 
and coherent public health response can be provided.  

Under  this  option,  the  Commission  will  be  empowered  to  coordinate  with  Member  States  as  a  priority  the  following 
measures:  

a.  Advisory  activities  on  preparedness  and  response  planning,  public  health  response  coordination  such  as  on  school 
closure,  travel  advice,  communication  strategies  and  messages,  common  strategies  on  vaccination.  On  this  basis  the 
Commission may adopt with the support of expert groups recommendations to Member States.  

b.  Non  legislative  acts  (i.e.  delegated  and  implementing  acts)  would  cover  e.g.  preparedness  plans,  guidelines  on 
protective  measures  to  be  taken,  notably  in  an  emergency  situation;  guidelines  on  information  and  guides  to  good 
practice for the public (e.g. hygiene measures). 

c.  Voluntary  mutual  agreements  between  concerned  Member  States  based  on  measures  recommended  by  the 
Commission that might be implemented at national level.  

In  addition,  a  new  and  voluntary  instrument  for  actions,  in  particular  a  mechanism  for  joint  procurement  of  medical 

215 
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http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:021:0032:0035:EN:PDF; annex I 
http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1247728923224 

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countermeasures, particularly pandemic influenza vaccines, would be established. 

Under this option, a unique structure to manage health emergencies at European level would be created, regardless of 
their cause. The positive impact would be to provide a platform where crises could be managed from the public health 
perspective by a single group of decision makers with a clear mandate as regards scope and responsibilities.  

For this option, this will have a positive impact on coordination of health measures at European level. There would be a 
clear  added  value  from  a  coordinated  European  response  because  Member  States  would  respond  in  a  coherent  way, 
thereby also strengthening trust in public authorities.  

In this way, the current work consisting of coordination 
of public health response done by the EWRS Network 
and the Health Security Committee, including work on 
communication would be merged in order to cover all 
serious  cross-border  threats  to  health  under  a  single 
structure. 

This option would specify, as it is currently the case for 
communicable diseases, the other types of threats to be 
covered,  criteria  for  notification  of  events  and  areas 
where measures could be coordinated at the EU level. 
It  would  provide  for  EU  action  through  advisory 
activities,  non  legislative  acts  and  instruments  for 
mutual  agreements  or  joint  actions  between  Member 
States.  

EU action as described above will – as it is the case for 
communicable  diseases  –  cover  as  a  priority  the 
following measures:  

a.  Advisory  activities  on  preparedness  and  response 
planning,  public  health  response  coordination  such  as 
travel  advice,  communication 
on  school  closure, 
strategies  and  messages,  common  strategies  on 
vaccination.  On  this  basis  the  Commission  may  adopt 
with the support of expert groups recommendations to 
Member States.  

legislative 

(i.e.  delegated 

b.  Non 
and 
acts 
implementing  acts)  would  cover  guidelines  on 
in  an 
protective  measures 
emergency  situation;  guidelines  on  information  and 
guides  to  good  practice  for  the  public  (e.g.  hygiene 
measures). 

taken,  notably 

to  be 

c.  Voluntary  mutual  agreements  between  concerned 
Member  States  based  on  measures  recommended  by 

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the Commission that might be implemented at national 
level.  

In  addition,  new  and  voluntary  instrument  for  joints 
actions, 
joint 
procurement  of  medical  countermeasures,  particularly 
pandemic vaccines, would be established. 

in  particular  a  mechanism 

for 

communication 

Common 
be 
developed;  the  communicators  would  be  integrated  in 
the crisis management process and would be s directly 
linked with the risk managers. 

strategies  would 

As regard the communication on public health risks, as described above, this option will enable a coordinated approach 
on communication issues (for example development of communication strategies, exchange of information, consultation 
and  coordination  on  messages  to  be  delivered  to  the  public,  better  responding  to  citizens'  needs  for  information, 
enhanced sharing of resources for engaging social media) in the context of a cross-border health threat integrating the 
issue  into  risk  management.  It  would  build  on  previous  initiatives  taken  on  a  voluntary  basis  on  the  Health  Security 
Committee Communicators' Network and in addition establish common communication strategies and envisage targeted 
campaigns which could help to improve awareness among the population and strengthen the implementation of public 
health  measures.  Combined  efforts  to  approach  and  convince  health  professionals  such  as  health  care  workers, 
pharmacists, patient groups can also be undertaken.  

The  Commission  would  be  empowered  to  define  the  procedures  on  how  this  coordinated  approach  would  be 
implemented in a coordinated way at EU level. 

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Annex 17: Examples of potential complementary EU stockpiles 

The number of doses held in a virtual or real EU stockpile would need to be agreed with the 
Member States. In any case, an EU stockpile would not replace national stockpiles but would 
be a complementary strategic stockpile that that can be quickly deployed to control the spread 
of a threat ('fire blanket' approach) in Member States. This applies when there are urgent and 
unforeseen needs that exceed the capacity of the national stockpile. Article 168 of the Treaty 
does  not  provide  a  possibility  for  an  EU  stockpile  replacing  national  stockpiles:  the 
organisation and delivery of health services and medical care is a Member State competence 
and  that  includes  the  autonomy  for  a  Member  State  to  decide  on  what  percentage  of  the 
population it wishes to cover with a stockpile. 

The cost of a complementary EU stockpile depends on the product to be stockpiled and the 
threat against which the countermeasure is intended to be deployed (determining the quantity 
to be stockpiled). A few cost examples (not including maintenance of the stock): 

• 

• 

• 

5%  population  coverage  'fire  blanket'  stockpile  of  pandemic  influenza  vaccines:  ~7 
euro/dose, 1-2 doses needed, i.e. 175 – 300 million euro 

1%  population  coverage  'fire  blanket'  stockpile  of  the  antiviral  'oseltamivir'  against 
pandemic  influenza:  extrapolated  from  a  stockpile  established  in  Asia  through  the 
ASEAN217/ASEF218  organisations  (where  a  stockpile  covering  1  million  people  did 
cost 40 million euro), a stockpile covering 5 million people would cost 200 million 
euro. 

0.5%  population  coverage  'fire  blanket'  stockpile  of  ciprofloxacin  against  anthrax: 
~0.75 euro/500mg, 2x 500mg x60 days needed, i.e. 225 million euro 

Similar  to  the  organisational  arrangements  made  for  the  Asian  stockpile  set  up  by 
ASEAN/ASEF, the distribution flow could be as follows:  

• 

• 

When  a  Member  State  is  facing  an  urgent  and  unforeseen  need  exceeding  the 
capacity of the national stockpile, it would simply make a request to the authorities in 
charge  of  the  oversight  of  the  stockpile  (e.g.  the  Commission  or  a  board  with 
representatives from the Commission and the Member States).  

After evaluation of the request (and of any requests by other Member States that may 
have  been  made),  the  manager  of  the  stockpile  (the  Commission,  an  agency,  a 
service  provider…)  can  be  instructed  to  transfer  the  requested  amount  (or  a  part 
thereof) to the MS's relevant authorities that would be responsible for its distribution 
to the affected citizens. 

The funding source (contributions from Member States or EU budget) for a complementary 
EU  stockpile  would  need  to  be  decided  at  a  political  level.  In  2006,  a  proposal  from  the 

217 

218 

Brunei,  Darussalam,  Cambodia,  Indonesia,  Laos,  Malaysia,  Myanmar,  Philippines,  Singapore, 
Thailand, Viet Nam 
EU + ASEAN + India, Japan, Korea, Mongolia, New Zealand, Pakistan, China (Russia and Australia 
are in the process of joining). 

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Commission to set up an EU stockpile of the antiviral 'oseltamivir' was withdrawn because no 
consensus could be reached at the Council (June 2006 Health Council) on the funding source. 

As medical countermeasures are provided free of charge to the public, no reimbursement 
issues are expected.

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Annex  18: 
countermeasures 

Illustration  of 

the 

joint  procurement  mechanism 

for  medical 

Legal basis for joint procurement

Participating Contracting Parties1 sign Joint Procurement Agreement
laying down decision making and organisational arrangements of the joint procurement.

All important decisions are taken by Joint Procurement Steering Committee (JPSC)
in which all Contracting Parties are represented.

Participating Contracting Parties put forward their requirements in terms of
technical characteristics of the product and number of doses

On the basis of the requirements of the Contracting Parties, tender documents are drafted and
– following approval by JPSC – a call for tender is launched

Evaluation of tenders

Award decision
by JPSC

NO

Procurement procedure
is abandoned

YES

Signature of framework contract(s)2
by participating Contracting Parties

NO

Award
procedure
is cancelled

Threat emerges

The Contracting Parties can order medical countermeasures
on the basis of the framework contract(s) they signed and
up to the amount of doses that are reserved for them

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a

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;
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o
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EN 

1 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)

100 
2 A framework contract guarantees a certain number of doses of a medical countermeasure that will be made available when
the signatory Contracting Parties wish to order. However, a framework contract does not put any obligation on Contracting
Parties to order the medical countermeasures

   EN 

 
 
 
 
 
Annex 19: Analysis of the impacts of the three options 

Rating: 

0 Baseline scenario; neutral;  
+ small positive impact;  ++ big positive impact 

- small negative impact; 

-- big negative impact 

Option 1: Status quo: Maintaining the current level of activities 

Assessment Criteria 

Rating  Motivation of the rating and aspects of the policy action necessary to achieve the impact 

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

0 

Impact on public health will be the same as it is now; conditions for public health protection will not be improved. 

2. Public health security structures 
and systems: Effectiveness219, 
efficiency220 and coherence221 as 
regards the objectives described in 
this initiative 

0 

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 

This  option  will  not  improve  effectiveness,  efficiency  and  coherence  related  to  structures  and  systems  of  public  health 
security. 

Incoherence and incompleteness would remain as regards the handling of serious cross-border threats to health. Disparities 
between the framework on communicable diseases and on other threats would be maintained leading to an unequal response 
to health-related crises. Preparedness and response planning, as well as risk monitoring, risk assessment and risk management 
of public health would be inadequately addressed for serious cross-border threats to health other than communicable diseases. 

219 
220 
221 

EN 

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 

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communication) 

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

0 

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) 

d. equitable access to medical 
countermeasures 

The  impact  of  option  1  would  be  low  as  the  current  system  would  be  maintained  but  not  strengthened;  a  common  EU 
approach on serious cross-border threats caused by biological (other than communicable diseases), chemical or environmental 
events would not be developed. Considerations of the European Parliament222 and the Council223 for providing better support 
for  the  Member  States  in  achieving  a  coherent  approach  to  preparedness  for  and  response  to  health  threats  and  especially 
public health emergencies of international concern as defined in the IHR would not be addressed. 

a. Under this option preparedness planning would remain as diversified as it is now. Member States may follow EU guidance 
related to generic and specific preparedness but are not obliged to implement it. This option will not improve the EU level of 
preparedness and response planning and will not provide a coherent approach. 

b. There will be no significant impact on preparedness in other critical sectors of society, therefore the interoperability will 
not be ensured.  

c. The questions of core capacity requirements for preparedness and response and EU tailor-made criteria for notification of 
health  threats will  not  be  addressed.  Parallel  and  uncoordinated  implementation  of  the  International  Health  Regulations  by 
Member  States  will  not  lead  to  any  common  baseline  for  EU  preparedness.  Differences  and  incompatibilities  between 
Member States will prevail in the absence of a robust solution. 

d. Under this option, no impact is expected in terms of improving access to medical countermeasures. As the proposed action 
only relies on national procurement procedures and a limited support from the EU, the shortfalls (limited purchasing power, 
etc.) identified and experienced by the Member States during the Pandemic H1N1 2009 will not be addressed.  

2.3. risk monitoring and assessment: 
coherent and comprehensive 
approach for 

0 

- identification (detection) and 
notification of health threats, based 
on improved linkage between 

Under option 1, impact would be low as there would not be a coherent and comprehensive approach for risk notification, risk 
monitoring and risk assessment.  

Coordination among networks and mechanisms in place would not be strengthened and no additional arrangements will be 
put  in  place  to  improve  coordination. For risk  monitoring  information available  from  rapid  alert  systems  for other policies 
will not be notified systematically to the public health authorities. The Commission would also not be notified of such threats 
through the IHR.  

222 
223 

EN 

European Parliament resolution of 8 March 2011 on evaluation of the management of H1N1 influenza in 2009-2010 in the EU (2010/2153(INI)) 
Council conclusions of 13 September 2010 on Lessons learned from the A/H1N1 pandemic – Health security in the European Union (12665/10) 

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existing monitoring and notification 
mechanisms and structures 

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

2.4. risk management: improved 
coordination :  

0 

- sustainable structure at EU level for 
any serious cross-border public 
health crisis; 

- clear mandate for this structure with 
stronger commitment of Member 
States 

2.5.crisis communication: improved 
conditions for crisis communication 

3. Social impacts 

0 

0 

As  regards  risk  assessment,  no  additional  impact  can  be  expected  either,  as  this  option  would  rely  on  networks  of  experts 
being  established under  the public health programme.  This  expertise  could  be  called upon on  an  ad  hoc basis.  In addition, 
incompatible risk assessments from  the public health perspective might  be delivered among different policy areas (such as 
civil or environmental protection) implicated in the same cross-sectoral crisis. This would not lead to strengthening capacities 
either in the short-term or long term, and gaps and inconsistencies would remain and may lead to inefficient and ineffective 
response.  

Option 1 may as it is the case now lead to inappropriate risk monitoring and risk assessment with negative consequences for 
public health response. 

Under  this  option,  impact  would  be  low  as  coordination  at  EU  level  would  neither  be  improved  nor  would  there  be  a 
sustainable structure for addressing all serious cross-border threats with a clear mandate and a strong commitment of Member 
States Considerations of the European Parliament224 and the Council225 for the possibility of a long-term solution on health 
security, including provision of a legal basis for the Health Security Committee, are not addressed. 

Risk  management  would  continue  to  be  ensured  by  two  existing  structures,  one  legally  based  (and  responsible  for 
communicable  diseases226)  and  another  one,  an  informal  entity  (the  Health  Security  Committee)  which  is  intended  to 
coordinate  public  health  response  mainly  for  other  health  related  threats,  including  pandemic  preparedness.  Therefore,  the 
current  overlap  of  formal  and  informal  structures,  in  particular  in  the  area  of  pandemic  preparedness,  would  persist. 
Furthermore, as neither the mandate of the Health Security Committee nor its scope would be changed under this option the 
current absence of a legal basis would not strengthen its role and public health measures would not be sufficiently coordinated 
under the status quo. 

The impact under this option is low as structures are not strengthened and conditions for communication will not be further 
improved.  This  would  result  in  non  implementation  of  "lessons  learnt"  from  the  evaluation  report of  H1N1  in 2009 which 
stressed the importance of improving public communication coordination at EU level for cross-border health threats. 

Under  this option no  changes  are  expected related  to  the employment,  labour  market  and  job quality.  Under  status  quo  no 
other  effects  on  society,  such  as  impacts  on  social  inclusion,  protection  of  particular  groups,  equality  of  treatment  and 
opportunities, non-discrimination, social protection and security as well as education can be expected.  

Communication: Under this option coordination of communication will not be improved and could lead to discrepancies on 

224 
225 
226 

European Parliament resolution of 8 March 2011 on evaluation of the management of H1N1 influenza in 2009-2010 in the EU (2010/2153(INI)) 
Council conclusions of 16 December 2008 on health security (16515/08) 
Early warning and response network, Decision 2119/98 (OJ L 268 3 10 1998, p.1) 

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4. Economic impacts 

0 

communication and messages for the general public, which could cause uncertainty among the population. As demonstrated 
during  recent  outbreaks  (for  example  E.  coli  STEC  0104)  this  could  result  in  EU  citizens  being  misinformed  because  of 
uncoordinated  and  conflicting  messages  and  finally,  lead  to  mistrust  towards  public  health  authorities  and  the  measures 
introduced for controlling an outbreak. 

Social inclusion and protection of particular groups, e.g. vulnerable groups: This option will not have particular impacts on 
vulnerable groups in terms of health protection. 

Solidarity  and  equitable  access  to  medical  countermeasures:  as  the  current  situation  will  be  maintained  and  the  identified 
shortfalls would not be addressed, the proposed activities under this option will have no impact on solidarity and equitable 
access to medical countermeasures between the Member States. As a result, this maintains a situation where, in case of cross-
border  health  threats,  Member  States  will  be  pitched  against  each  other  by  the  producers  for  access  to  medical 
countermeasures.  Cooperation  with  other  sectors  of  society  will  continue  to  be  done  on  an  ad-hoc  basis  and  therefore  this 
option will not strengthen the cooperation in a sustainable and systematic way. 

Serious cross-border health threats can affect large number of persons and entire regions and therefore have repercussions on 
the  economy  due  to  absenteeism  of  people  at  work,  costs  for  treating  patients,  disruption  of  businesses  and  productivity 
losses.  For  example,  in  a  pandemic  it  is  anticipated  that  there  will  be  growing  demand  for  hospitalisation  and  medical 
treatment. 

Internal market, free movement of people, capital, goods and services (e.g. travel restrictions): The lack of sound coordination 
at  the  EU  level  could  result  in  diverse  and  incoherent  responses  in  an  event  of  a  public  health  crisis.  As  a  consequence, 
internal  market  and  external  trade  functions  could  be  disrupted  leading  to  substantial  economic  losses.  Disruption  in  the 
internal market might occur and limit access to essential goods and services, and in addition might have serious consequences 
as regards capacities of the health system to respond effectively to the crisis.227  

An example of a public health outbreak that had a major impact on the economy is the Severe Acute Respiratory Syndrome 
(SARS) outbreak in 2003 which caused anxiety around the globe due to its novelty and potential for a serious pandemic. The 
estimated income loss ranges from US $ 12.3-28.4 billion for East and Southeast Asia as a whole228.  

In  terms  of  influenza  epidemics  in  industrialised  countries  total  estimated  direct  and  indirect  costs  may  reach  EUR  56.7 

227 
228 

See tables 1 and 2 in annex 6  
See end note 28 related to table 1 in annex 6  

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million  per  million  people229.  Therefore,  a  coordinated  approach  to  mitigate  the  spread  of  a  disease  may  have  a  positive 
impact on economy and reduce costs. 230 

Preparedness  of  critical  sectors  of  society  and  interoperability:  There  is  currently  a  limited  cross-sectoral  coordination  to 
ensure business  continuity  in  critical  sectors  and  therefore  there  can  be  an  important negative  economic  impact  in  a  major 
public  health  crisis  such  as  a  pandemic.  Public  health  measures  taken  during  a  pandemic  have  the  potential  to  cause 
unintended negative effects on other parts of society and the economy. This may result from restrictions on daily activity for 
example as a result of a social distancing policy such that schools, businesses and government offices close for a period of 
time  in an effort to reduce transmission and mass gatherings are cancelled. The need for increased preparedness in sectors 
other than health has been identified as an area where pandemic preparedness needs to be strengthened. This increased multi-
sectoral preparedness is needed both to support the public health response and mitigate the overall effect of the pandemic on 
society.  The  World  Health  Organization  (WHO)  has  presented  this  approach  under  the  label  "whole  society  approach"231 
Actions  undertaken  by  one  Member  State  alone  may  also  significantly  damage  the  interest  of  other  Member  States  (e.g. 
interruption  of  trade  and  critical  services  such  as  transport,  IT  technologies,  energy).  The  European  Parliament  and  the 
Council, respectively in its resolution of 8 March 2011 on evaluation of the management of H1N1 influenza in 2009-2010 in 
the  EU  and  in  its  conclusions  of  12  October  2009  on  Pandemic  (H1N1)  2009  –  strategic  approach,  also  focus  on  the 
importance of cooperation on multi-sectoral issues related to public health. At the start of pandemic (H1N1) 2009, Mexico 
implemented social distancing measures (schools, government offices and businesses) were shot down for a week. This has 
had a major impact on the Mexican economy232.  

Innovation,  development  and  research  in  the  field  of  medical  countermeasures  (impact  on  the  sector  of  pharmaceutical 
industry):  Under  the  status  quo  option  capacity  building  for  seasonal  influenza  vaccine  production  and  manufacturing  is 
envisaged with an indirect effect on pandemic influenza vaccine production. However, this depends on national planning on 
vaccination for seasonal influenza, and therefore its implementation depends entirely on MS and it is the MS responsibility to 
review their vaccination strategies for seasonal flu. Thus, the impact will depend on whether MS are committed to support 
approaches to increase production capacity generally.  

It should be noted that under option 1 research and development on pharmaceutical products is generally supported through 

229 

230 
231 
232 

233 

EN 

to 

the  proposal 

Explanatory  Memorandum 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0353:FIN:EN:HTML 
http://www.who.int/countries/eth/areas/cds/en/index.html 
http://www.who.int/csr/disease/influenza/CP045_2009-0808_WOS_Pandemic_Readiness-FINAL.pdf 
Stern A; Markel H What Mexico Taught the World About Pandemic Influenza Preparedness and Community Mitigation Strategy, JAMA, September 16, 2009; 302:1221-
1222 
http://ec.europa.eu/research/fp7/index_en.cfm?pg=health 

influenza  vaccination;  COM(2009)  353 

recommendation  on  seasonal 

final/2;  http://eur-

for  a  Council 

105 

EN 

 
  
                                                                                                                                                                                                                                                    
the EU Framework programmes for Research and Development. However, this allows only for long term solution to increase 
availability of  vaccines and medical countermeasures and does not have a direct impact on short term availability of these 
products in an outbreak or major public health event.233  

5. Financial implications 

0 

The main stakeholders that are affected by the health security initiative are the Member States and the European Commission; 
in an indirect way private companies might be affected. 

Member States: There are no additional costs for reporting, meetings or notification of threats  

The  Commission  will  also  not  have  additional  costs;  the  level  of  costs  for  staff,  administration  such  as  organisation  of 
meetings will stay the same. As option 1 is consistent with the baseline scenario, i.e. the current situation resources to support 
work on combating serious cross-border health threats will mainly be allocated by the administrative budget of the EU (for 
example  to  organise  meetings)  and  the  financial  means  of  the  public  health  programme.  Between  2008  and  2013  the  total 
budget  for  the  health  programme  is  EUR  321.5  million.  The  activities  covered  and  co-funded  under  the  programme 
correspond  well  with  the  objectives  of  the  health  security  initiative.  E.g.  in  2010,  13  projects  were  supported  with  an  EU 
contribution of EUR 8.6 million and in 2011, two projects with an EU contribution of EUR 800,000 will be financed. For 
2012, EUR 3.6 million are ear marked for five projects related to health security.  

Other Stakeholders/private companies will not be affected. 

No benefits or efficiencies can be expected; the inefficiencies and overlaps in the current situation will persists and certainly 
not lead to reduction of financial implication. 

Administrative costs will be the same as in the current situation.  

6. Administrative burden 

0 

The main stakeholders that are affected by this option are the Member States and the European Commission. 

The current situation would persist; administrative resources (e.g. human resources) for both the Commission and Member 
States would remain the same. There would be no additional costs for notification, coordination or reporting. 

Negative impacts are related to overlaps concerning the use resources between the EWRS network and the Health Security 
Committee related to communicable diseases in the EU. Negative impacts also relate to the lack of sustainable capacity to 
address  serious  cross-border  health  threats  other  than  communicable  diseases,  in  particular  for  the  Commission;  Ad-hoc 
solutions  mobilising  external  expertise  may  affect  the  quality  of  independent  scientific  advice  as  external  experts  in 
emergency situations may not be available as needed due to prior commitments and the process of ending expertise at all may 
be time-consuming. 

EN 

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7. EU added value 

8. Impact at International level 

0 

0 

The  EU  added  value  in  handling  a  serious  cross-border  health  threat  will  remain  unchanged  as  the  current  system  is  not 
strengthened.  

Option 1 has an impact at international level in case of serious cross-border health threats potentially relevant outside the EU, 
as for example the recent outbreak of E. coli STEC O104 (impact on trade of food with 3rd countries) and of cholera related 
with  Haiti  earthquake  in 2010  (involvement  of  the  EU  in  combating  the  disease  on  the  spot),  or  in  case  of  contact  tracing 
procedures to identify potentially contaminated persons (e.g. multi-drug resistant Tuberculosis).  

Information  available  on  outbreaks  or  serious  threats  due  to  communicable  diseases  is  potentially  accessible  and  can  be 
provided and exchanged with those third countries concerned by these events either directly or through other mechanisms in 
place  (WHO  and  the  Global  Health  Security  Initiative  Network).  The  impact,  however,  can  be  considered  as  low,  as  the 
mechanism is neither formal nor sustainable. 

Overall,  and  in  particular  for  other  serious  cross  border  threats  to  health,  collaboration  at  international  level  will  not  be 
improved. 

EN 

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Option 2: Separate and different handling of serious cross-border threats to health – enhanced cooperation by using soft instruments based on 
a voluntary approach 

Assessment Criteria 

Rating  Motivation of the rating and aspects of the policy action necessary to achieve the impact 

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

+ 

Impact  on  public  health  would  be  improved  as  the  overall  situation  for  preparedness  and  response  to  a  crisis  will  be 
strengthened. Future policies would be based on recommendations supported by Member States; hence the commitment of 
Member States would be higher than today. 

2. Public health security structures 
and systems: Effectiveness234, 
efficiency235 and coherence236 as 
regards the objectives described in 
this initiative 

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 
communication) 

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

+ 

+ 

This option would  improve effectiveness, efficiency  and  coherence related  to public health  security  structures  and  systems 
provided that Member States are committed to agree on recommendations and implement them. 

Under this option, serious cross-border health threats are still addressed separately (division between the EU legal regime on 
communicable  diseases  and  the formal  Commission framework on other  threats). Although other  threats  are dealt within  a 
formal structure (Commission expert group), the integrated approach is not achieved as communicable diseases are covered 
by EU legislation which is legally binding on Member States and that other threats follow under a soft instrument which is 
not binding for Member States. 

This  option  would  strongly  commit  the  Commission  services  to  coordinate  preparedness  and  public  health  response  in 
different policies which would have a certain impact on respective national policies and therefore facilitate the coordination 
of health-related crisis among sectors in Member States. 

This option would bring more consistency and compatibility in preparedness at EU level and across sectors because it would 
move from the current voluntary and informal approach under the baseline and option 1 scenario, towards a more formalised 
approach with reporting requirements.  

Member  States  would  be  more  committed  to  implement  Council  recommendations  related  to  generic  and  specific 

234 
235 
236 

EN 

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 

108 

EN 

 
  
 
 
 
 
                                                 
- generic and specific preparedness 

- ensuring coherence and 
interoperability among critical 
sectors of society 

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

- access to medical countermeasures 

preparedness, which would increase impact on MS. If MS contribute to guidance and implement it accordingly on the basis of 
a soft instrument such as a Council Recommendation, there would be an improvement of preparedness as common indicators 
and  arrangements  can  be  put  in  place,  and  progress  can  be  monitored  and  reported  by  the  Commission.  In  addition,  the 
Commission would continue to encourage exchange of best practices and provide incentive measures, using the EU health 
programme  as  is  currently  the  case.  This  would  lead  to  a  wider  dissemination  of  best  practices  on  preparedness  plans  and 
probably even trigger innovative aspects, sustainability, however, cannot be achieved in that way given that these activities 
are  carried  out  using  project  grants  of  limited  duration.  As  regards  interoperability  between  different  sectors  the  mutual 
exchange of preparedness plans would increase the coherence of overall preparedness at EU level.  

In  addition,  notification  criteria  as  set  out  in  the  IHR237  would  be  adapted  for  EU  requirements  in  order  to  ensure  that  all 
serious  cross-border  health  threats  would  be  notified  (please  refer  to  the  part  for  Risk  monitoring  and  assessment  for 
additional information). 

The  impact  of  this  option  on  access  to  medical  countermeasures  is  expected  to  be  an  improvement  over  option  1.  Indeed, 
incentive  measures via  the Innovative  Medicines  Initiative  could support  research  into the  development  of  new  production 
techniques to improve production capacity for medical countermeasures. For example, further research into optimising cell-
based production for pandemic influenza vaccines could yield a considerable increase in production capacity. An increased 
production  capacity  means  that  a larger  proportion  of  the  population  can  be  protected or  treated  within  a  short  time  frame 
when a threat emerges. 

In  addition,  this  option  foresees  the  setting  up  of  a  complementary  EU  stockpile  which  could  alleviate  urgent/unforeseen 
needs exceeding the capacity of national stockpiles. In the area of communicable diseases, such a complementary stockpile 
may be able to contain the threat by stopping further spread ('fire blanket' approach).  

237 

http://www.who.int/ihr/annex_2_guidance/en/index.html 

EN 

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2.3. risk monitoring and assessment: 
coherent and comprehensive 
approach for  

+ 

- identification(detection) and 
notification of health threats, based 
on improved linkage between 
existing monitoring and notification 
mechanisms and structures 

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

2.4. risk management: improved 
coordination - sustainable structure at 
EU level for any cross-border public 
health crisis;  

+ 

clear mandate and strong 
commitment of Member States 

In comparison to option 1, improved coordination of existing monitoring and alert tools would step up the level of capacity 
for detection and notification and therefore allow for a more rapid and comprehensive reaction to a cross-border health threat. 

Knowledge from other rapid alert systems will be improved and arrangements for mutual alerting will be established at EU 
level. Mutual notification from one system to another would allow for an improved risk assessment in full knowledge of all 
aspects of the alert and contribute therefore to a coordinated and comprehensive response among relevant sectors. The impact 
of a more formalised system will be that public health authorities will be informed earlier when alerts are notified through 
other EU alert systems and vice versa, and define at an earlier stage whether the notified events would constitute a serious 
cross-border threat to health.  

There  is  also  improved  impact  as  notification  would  be  linked  to  IHR  and  EU  tailor-made  criteria  for  notification  will  be 
defined at EU level, taking severity into account.  

A  positive  impact  would  be  that  due  to  arrangements  (to  be  established  prior  to  the  events)  with  existing  networks,  EU 
Agencies  and  expert  groups  and  due  to  standard  operation  procedures  on  information  exchange,  rapid,  coherent  and 
comprehensive public health risk assessment compatible among different policy areas could be carried out. 

This option would significantly strengthen risk assessment capacities in the short and long term and create a basis for solid 
and independent scientific expertise to respond to serious cross-border threat to health. 

The impact of option 2 would be that two independent structures would be clearly distinguished and mandated to manage and 
coordinate  health  related  crisis:  the  EWRS  network  for  communicable  diseases  and  a  newly  created  formal  Commission 
expert group (that would replace the informal Health Security Committee) for all other serious cross-border threats to health. 

These redefined structures would be sustainable and improve effectiveness of coordination of health crisis management in the 
EU. 

As  a  result  of this  option,  the  Commission  would be  able  to  recommend  measures for risk  management  to  Member States 
based  on  the  expertise  of  the  new  expert  group.  Although  this  would  increase  the  sustainability  of  risk  management  and 
coordination  for  serious  cross-border  health  threats,  the  EU  would  still  have  a  weaker  approach  for  threats  other  than 
communicable diseases, as measures will remain non binding for the first and binding for the second. As the former Health 
Security  Committee  would  become  a  Commission  advisory  group  instead  of  a  Council  group,  it  will  not  have  the  same 
strategic status and role as at present. 

2.5.crisis communication: improved 
conditions for crisis communication 

+ 

Under  this  option  the  Commission  could  recommend  joint  communication  messages  to  Member  States,  shared 
communication approaches and guidelines.  

EN 

110 

EN 

 
  
3. Social impacts 

+ 

Similarly to the status quo option 2 will not have impacts on employment, labour market and job quality.  

This option would have a more significant impact than the measures under option 1. 

Communication:  As  described  above  this  option  would  provide  the  Member  States  with  the  opportunity  to  commit 
themselves  on  a  voluntary  basis  to  provide  common  and  shared  messages  to  the  media.  This  option  would  have  a  more 
significant  impact  that  the  actions  under  option  1.  Coordination  of  communication  would  also  have  a  beneficial  effect  on 
citizens as messages issued to the public would be more coherent within the EU and not contradictory. Thus, trust in public 
health authorities to manage a health crisis would increase.  

Social inclusion and protection of particular groups, e.g. vulnerable groups: This option will not have significant impacts on 
vulnerable groups in terms of health protection. 

Solidarity and equitable access to medical countermeasures: a complementary EU stockpile of medical countermeasures that 
can be deployed to help Member States with urgent/unforeseen needs is expected to improve solidarity, and – to a limited 
degree  –  improve  access  to  medical  countermeasures.  This  option  2  also  includes  increased  transparency  between  the 
Member States regarding their respective procurement processes and pooling of expertise in public procurement. Although 
this would improve solidarity between the Member States it would not ensure equitable access to medical countermeasures.  

Cooperation with other important sectors of society would be improved under this option as notification systems would be 
linked better and structures for risk assessment and management in the various sectors would be better interlinked to improve 
public health protection. In particular a newly created expert group would provide a platform for more effective sharing of 
information  of  coordination  of  actions  and  measures  between  different  sectors  in  relation  to  serious  cross-border  health 
threats. 

4. Economic impacts 

+ 

As  described  under  option  1  serious  cross-border  health  threats  can  affect  large  number  of  persons  and  entire  regions  and 
therefore have repercussions on the economy due to absenteeism of people at work, costs for treating patients, disruption of 
businesses and productivity losses. 

Impacts under this option depend to a large degree on the cooperation and commitment of Member States to implement EU 
guidance developed under "soft law" such as recommendations. Against this background the following positive impact could 
be achieved. 

Internal  market,  free  movement  of  people,  capital,  goods  and  services  (e.g.  travel  restrictions):  The  improved  interaction 
between monitoring and alert systems in different policy areas would lead to a more rapid and substantiated risk assessment 
and  management  of  a  given  threat.  Better  coordination  would  therefore  allow  responding  earlier  in  order  to  contain  and 
mitigate threats better. As a consequence, internal market and external trade functions might be less disrupted and economic 

EN 

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EN 

 
  
losses could be reduced238. 

The E. coli STEC O104 outbreak has shown that economic damage can be immediately huge and substantial; therefore it is 
important to respond rapidly and effectively to a health crisis. (see table 1 in annex 6: Effects of serious cross-border threats 
to health on society). 

Preparedness  of  critical  sectors  of  society  and  interoperability:  Under  this  option  cross  sectorial  cooperation  would  be 
improved;  other  sectors  would  be  earlier  informed,  better  prepared  and  hence  equipped  to  respond  effectively  to  a  given 
threat. In return the public health sector would also benefit as exchange of information would be mutual. 

Innovation,  development  and  research  in  the  field  of  medical  countermeasures  (impact  on  the  sector  of  pharmaceutical 
industry):  In  terms  of  availability  of  medical  countermeasures option  2  is  expected  to be  an  improvement  over  the current 
situation  as  support  of  development  and  research  of  medical  countermeasures  would  be  strengthened  via  the  existing 
Innovative Medicines Initiative (IMI). For example, for medical countermeasures that have already been developed, research 
could focus on improved production techniques to increase the industry's production capacity. However, for the development 
of  new  medical  countermeasures,  IMI  would  only  address  the  initial  phases  of  research  and  development  as  it  does  not 
provide support for clinical studies.  

5. Financial implications 

- 

The  main  stakeholders  under  this  option  are  the  Member  States  and  the  Commission.  Except  for  joint  procurement,  no 
additional costs either for Member States or for the Commission are expected under this option.  

Proposals  on  preparedness,  assessment  and  management  will  be  carried  out  in  the  existing  framework  both  at  the  level  of 
Member States and in the Commission. There will be no additional costs for notification, reporting or additional meetings; 
however, the quality of the outcomes is expected to be higher and would commit Member States more. 

As under option 1 the available means of the health programme and the existing budget for administrative costs will be used. 

The parts of option 2 relating to enhanced cooperation would have no substantial financial impacts as existing mechanisms 
and systems in place would be maintained. 

Regarding  research  and  development  of  medical  countermeasures,  existing  financial  mechanisms  will  be  used  as  much  as 
possible (Innovative Medicines Initiative).  

Option  2  remains  at  the  level  of  cooperation  between  individual  procurements  with  no  additional  significant  costs  for  the 
Member  States.  However,  there  would  be  no  financial  gain  either  as  the  purchasing  power  and  ability  to  obtain  better 

238 

See tables 1 and 2 in annex 6  

EN 

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EN 

 
  
                                                 
financial and contractual conditions will remain much weaker compared to the option of a full joint procurement, as proposed 
under Option 3. 

Financial implications of the potential setting up of a complementary EU stockpile of medical countermeasures are illustrated 
in  annex  17.  Because  a  complementary  EU  stockpile  would  mean  that  Member  States  still  needed  to  procure  medical 
countermeasures for their national stockpiles individually, the weak purchasing power identified as a major weakness during 
the  influenza  H1N1  (2009)  pandemic  would  not  be  addressed.  In  2006,  the  Commission  already  proposed  to  set  up  a 
complementary stockpile of antivirals at EU level but this initiative was withdrawn following political opposition from the 
Council in 2006 on grounds of subsidiarity and costs239.  

Under this option governance would be improved as mandates of the two relevant committees, namely the Early Warning and 
Response System Network (EWRS Network) and a newly created expert group (formerly Health Security Committee) would 
be clearly defined. Responsibilities would be divided and the new expert group would be formalised under the Commission 
setting. This clear division of work would save resources in Member States as well as in the Commission as there would be 
no  overlaps  in  responsibilities.  The  operating  costs  for  the  two  committees  would  be  reduced  as  there  is  no  overlap  in 
organising  meeting  and  addressing  twice  same  events  in  different  expert  groups.  However,  as  there  would  still  be  two 
separate entities administrative burdens would be only reduced marginally. 

No  additional  administrative  burden  would  arise  from  reporting  to  other  EU  Institutions  because  already  today  the 
Commission reports annually to the Council on the activities and progress of the Health Security Committee. 

As  regards  access  to  medical  countermeasures  the  administrative  burden  would  also  be  reduced  for  Member  States  as 
cooperation between individual national procurement procedures would allow pooling national expertise 240. 

If stockpiles at European level would be created additional administrative capacities would be needed in particular during the 
setting up phase.  

The EU added value would be increased as the coordination of preparedness for and response to a cross-border health threats 
could  be  enhanced  at  the  EU  level  through  improved  and  coherent  preparedness,  risk  monitoring,  assessment  and 
management.  Development  of  core  capacities  at  EU  level,  strengthened  links  between  notification  systems  of  different 
sectors, and improved functioning of the two committees at the EU level would contribute to this objective.  

6. Administrative burden 

0 

78. EU added value 

+ 

239 
240 

http://europa.eu/rapid/pressReleasesAction.do?reference=IP/06/732&format=PDF&aged=1&language=EN&guiLanguage=fr 
In the case of Austria, savings involved in a joint procurement amounted to 60% of administrative costs: 
http://ec.europa.eu/environment/gpp/pdf/toolkit/module1_factsheet_joint_procurement.pdf  

EN 

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80. Impact at International level 

+ 

In  addition,  as  regards  medical  countermeasures  and  their  procurement  in  particular,  the  transparency  of  procedures  and 
conditions would improve exchange of best practices of purchase agreements and therefore help Member States across the 
Union.  

Under  this  option,  the  impact  related  to  international  level  would  be  stronger  than  in  status  quo  as  this  option  would  also 
address the reporting conditions of threats other than communicable diseases being notified to WHO through the IHR without 
informing the EU. Under this option, notification would be linked to IHR and EU tailor-made criteria for notification will be 
developed at EU level. 

EN 

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Option  3:  Establish  common  EU  legal  framework:  covering  all  serious  cross-border  threats  to  health  –  improved  cooperation  and  legally 
binding measures 

Assessment Criteria 

Rating  Motivation of the rating and aspects of the policy action necessary to achieve the impact 

++ 

++ 

++ 

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

systems: 

2.  Public  health  security  structures 
Effectiveness241, 
and 
efficiency242  and  coherence243  as 
regards  the  objectives  described  in 
this initiative 

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

to 

The EU citizens would be protected in the same way from communicable diseases and from other serious cross-border threats 
to health independently of their origin (biological, chemical, environmental). 

Option  3  would  be  the  option  that  improves  most  effectiveness,  efficiency  and  coherence  related  to  preparedness,  risk 
monitoring, assessment and management for health security in the European Union.  

In addition, it would be the best option to achieve the objective to improve availability and access to medical countermeasures 
by the Member States and therefore strengthen the capacity of Member States to mitigate the public health impact of a serious 
cross-border health threats. 

Handling of all serious cross-border threats to health would be ensured in the same way under a single and robust framework. 
Shared common standards on preparedness related to minimum core capacities for surveillance and response would be agreed 
at  EU  level.  Based  on  these  common  standards,  specific  procedures  would  be  set  up  to  coordinate  a  coherent  and 
comprehensive  approach  at  EU  level.  This  strengthened  EU  collaboration  would  cover  monitoring,  early  warning  and 
combating serious cross-border threats to health and would be ensured through the following actions:  

a.  The  detection  of  serious  cross-border  threats  to  health  would  be  considerably  improved  at  EU  level  as  the  monitoring 
systems in place in different policy areas would collaborate closely together and exchanged information on potential serious 
cross-border threats to health. 

b.  All  alerts  related  to  serious  cross-border  threats  to  health,  including  those  notified  under  IHR,  would  be  reported  at  EU 
level according to the EU tailor-made criteria for notification. 

c. Public health risk assessment would cover all serious cross-border threats to health. Existing entities responsible for risk 

241 
242 
243 

EN 

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 

115 

EN 

 
  
                                                 
assessment would be identified in advance depending of the type of threat to timely deliver independent scientific evaluation 
of  risks  to  public  health.  The  Commission  would  ensure  that  public  health  risk  assessment  for  non-communicable  disease 
threats is coherent and comprehensive from the point of view of various policies. 

d. The EU coordination of public health response to all serious cross-border threats to health would be ensured in a robust 
way  and  would  be  dealt  under  a  common  "all-hazards"  approach.  There  would  be  no  distinction  between  communicable 
diseases and other threats as regards the implementation at EU level of public heath measures. The communication activities 
related to all serious cross-border threats to health would also be coordinated in a solid manner as they are strictly linked to 
the risk management. 

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

+++ 

a.  Under  this  option  preparedness  planning  would  be  significantly  improved  and  would  become  much  more  coherent  than 
under the two first options as preparedness would be based on shared and common standards for serious cross-border threats 
to health and would be mandatory for Member States. This would be a major step forward in setting a common approach at 
EU level. 

a. generic and specific preparedness 

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

ensuring 
c.- 
interoperability 
sectors of society 

coherence 
among 

and 
critical 

d  equitable  access 
countermeasures 

to  medical 

b. General criteria for core capacity for surveillance and response based on those set out in Annex 1 of the IHR244 would be 
incorporated in the EU legislation and adapted accordingly to EU common standards. Better coordination in the EU of IHR 
implementation by the Member States would also have positive effects to the IHR and would support WHO. There would be 
less burden on MS who would only have to make one report on improving core capabilities 

c. Impacts would also be positive for cross-sectoral cooperation in reaching a coherent level of preparedness for serious cross-
border health threats among critical sectors of society and across Member States as the shared standards would be applied by 
different sectors. 

d. This option would be the best one to achieve the objective to improve availability and access to medical countermeasures 
by the Member States in the event of a cross-border health threat as it provides a legal basis for setting up a mechanism for 
joint procurement of medical countermeasures, in particular pandemic influenza vaccines.  

2.3. risk monitoring and assessment: 
coherent 
comprehensive 
approach for  

and 

++ 

The impact of this option would be that notification of threats would be improved due to enhanced cooperation with existing 
alert systems and networks, EU tailor-made criteria for notification and thus, better identification of alerts with public health 
significance would be achieved. This impact can already be achieved by this flexible and informal approach which is the most 

244 

http://whqlibdoc.who.int/publications/2008/9789241580410_eng.pdf 

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identification(detection) 

and 
- 
notification  of  health  threats,  based 
on 
between 
existing  monitoring  and  notification 
mechanisms and structures 

improved 

linkage 

-  improved  capacities  for  robust, 
reliable,  compatible  between  sectors 
and 
risk 
public 
assessment  for  other  serious  cross-
border threats to health 

health 

rapid 

risk  management: 

2.4. 
improved 
coordination  -  sustainable  structure 
at  EU  level  for  any  cross-border 
public health crisis;  

++ 

clear 
commitment of Member States 

mandate 

and 

strong 

appropriate because events arising from causes other than communicable diseases are not regular and are less frequent than 
communicable disease events245.  

Similarly, in the area of risk assessment legal arrangements are not required as positive effects can already be achieved by 
enhanced  and  sustainable  cooperation  with  existing  networks  of  Member  State  experts,  relevant  Commission  services,  EU 
agencies, and international organisation. In order to strengthen these already existing capacities complementary action (e.g. 
through  a  framework  contract)  would  be  undertaken  to  bridge  existing  gaps  in  the  current  structures.  This  would  ensure  a 
capacity when needed for a robust, reliable and rapid public health risk assessment.  

The impact of this option for risk monitoring and assessment is less than would be achieved by a legal solution. However, a 
stronger and more formal option is not considered proportionate, nor required by the frequency of such events. The option 
would,  however,  as  has  been  noted,  require  continued  investment  at  the  EU  level  and  at  national  level.  It  would  also  in 
conclusion address the objectives set out for risk monitoring and assessment under the present initiative to a satisfactory if not 
ideal level. 

The positive impact would be to provide one unique structure where all serious cross-border health crises could be managed 
from  the  public  health  perspective.  This  structure  merges  the  existing  formal  EWRS  network  and  the  informal  Health 
Security  Committee.  A  newly  established  committee/expert  group  would  have  a  clear  mandate  as  regards  scope  and 
responsibilities to overcome the current challenges in coordination of response to serious cross-border health threats. There 
would  be  a  clear  added  value  from  a  coordinated  European  response  because  Member  States  would  respond  in  a  coherent 
way, thereby also strengthening trust in public authorities.  

This  solution  would  also  put  on  a  strong  formal  footing  the  management  structure  on  health  security  as  requested  by  the 
Council. 

Contributing to this positive impact the Commission would be empowered to coordinate with Member States as a priority the 
following actions: Commission advisory activities, non legislative acts, joint actions (such as joint procurement of medical 
countermeasures)  and  voluntary  mutual  agreements  between  Member  States  that  might  be  implemented  at  national  level 
following recommendations from the Commission.  

2.5.crisis  communication:  improved 
conditions for crisis communication  

++ 

The  impact  of  option  3  would  be  greater  than  the  other  two  options  as  the  procedures  for  effective  communication 
coordination across the EU would be implemented in a coherent way by the Member States and in addition, Member States 
would agree on communication strategies and key messages; this would have a more structured and far reaching impact as 
e.g. identified target groups could be reached throughout the EU; in addition the communication activities would be supported 

245 

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by improved tools. Such an improved coordinated approach on communication issues, would also include e.g. development 
of communication strategies, enhanced of information increased media monitoring in order to better and quickly understand 
the needs for information and the concerns of citizens. 

In  addition,  risk  and  crisis  communication  would  be  extended  to  cover  all  serious  cross-border  health  threats  and  cross 
sectoral cooperation on communication would be enhanced in a public health crisis. 

3. Social impacts 

+ 

Option 3 would not have significant impacts on employment, labour market and job quality. 

Communication:  improved  coordination  of  communication  would  also  have  a  beneficial  effect  on  citizens  as  shared  and 
coordinated messages issued to the public would be coherent within the EU and not contradictory. Thus, trust in public health 
authorities to manage a health crisis would significantly increase.  

Along with better communication a coordinated approach on medical countermeasures (such as a joint procurement scheme) 
would  also  result  in  a  more  favourable  public  opinion  and  more  confidence  in  measures  undertaken  by  public  health 
authorities. 

Social  inclusion  and  protection of particular  groups,  e.g. vulnerable  groups:  In  the  context  of  a  pandemic  influenza  a  joint 
procurement mechanism would result in higher levels of protection for vulnerable groups due to better synchronised and more 
effective vaccination campaigns. 

Cooperation with other important sectors of society will be improved under this option as notification systems will be linked 
better and structures for risk assessment and management in the various sectors will be better interlinked to improve public 
health protection. There would also be only one counterpart for other sectors to address all serious cross-border health threats, 
thus providing improved means for inter-sectoral cooperation. 

Solidarity  and  equitable  access  to  medical  countermeasures  Joint  procurement  mechanisms  for  medical  countermeasures 
promotes  solidarity  by  ensuring  that  participating  countries  have  a  minimum  level  of  equitable  access  to  medical 
countermeasures. 

4.. Economic impacts 

++ 

As  described  under  the  previous  options  serious  cross-border  health  threats  can  affect  large  number  of  persons  and  entire 
regions and therefore have repercussions on the economy due to absenteeism of people at work, costs for treating patients, 
disruption of businesses and productivity losses.  

The positive impacts described already under option 2 would be increased as measures foreseen under option 3 are mainly 
legally binding. 

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In addition in the field of innovation, development and research the setting up of a joint procurement mechanism on medical 
countermeasures  would  strengthen  the  supply  of  medical  products  and  encourage  existing  and  potential  new  supplier  to 
develop new products because of guarantees related to public long term contracts. 

5. Financial implications 

- 

The main stakeholders under this option are the Member States, the Commission and private companies in the health sector 
and in other sectors.  

1. Costs for preparedness, assessment and management of the Health Security Initiative 

Member States:  

• 

• 

• 

• 

Notification costs are not expected to increase significantly as Member States are already obliged to report either at 
the  EU  level  on  communicable  diseases  or  to  the  WHO  under  the  International  Health  Regulations  on  "all 
hazards". Reviewing processes and procedures would need to be envisaged, but the costs for this can be considered 
marginal.  

The  new  activity  of  obliging  the  Member  States  to  set  up  generic preparedness planning  would be based  on  the 
previous work and existing mechanisms. Administrative costs would not significantly increase. Member States are 
already obliged to do this under the implementation of the International Health Regulations. 

The costs for coordination meetings may be at the same level or even less given the comprehensive mandate of the 
health group for all serious cross border threats to health. 

As regards the newly established reporting and monitoring procedures to implement the improved health security 
framework the following costs per Member State can be envisaged: 0.3 – 0.5 Full Time Equivalent for a national 
expert over a period of 2-3 months to address reporting. 

Commission: 

• 

• 

As  regards  preparedness  additional  costs  can  be  expected  in  particular  related  to  fees  for  human  resources  and 
provision  of  technical  equipment;  however,  it  is  planned  to  cover  these  staff  capacities/overhead  costs  by 
reorganising the human resources available and by building on existing platforms. Hence, the additional costs are 
considered marginal. 

If a more sustainable solution on risk assessment would be set up on a formal basis building on existing systems 
and better linking them this would require additional financial resources from the EU health programme (500.000 - 
1  Mio  €  per  year  in  addition)  to  set  up  framework  contracts  in  order  cover  existing  gaps  by  making  expertise 

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available where needed. 

The  calculation  is  based  on  experience  with  a  similar  pilot  project  for  assessment  of  health  threats  other  than 
communicable diseases in the past. The intended framework contract is planned to allow for such gaps to be filled by 
establishing  permanent  networks  of  national  correspondents  between  health  authorities  and  agencies  competent  in 
assessing specific health threats, for example related to toxic chemicals (94 poison centres in the EU). 

Cross  border  threats  caused  by  chemical,  biological  and  environmental  events  do  not  occur  as  often  as  communicable 
diseases. Based on IHR notifications we can expect on average 5-6 such events per year246. Under EU tailor made criteria 
for these incidents the threats notified - based on experience with alerts for communicable diseases - could amount to 20 -
25 per year. The frequency of such events is likely to increase due to increases in global travel and trade, climate change 
and latent risk of criminal and terrorist attacks. 

Therefore,  the  financial  burden  of  the  measure  needed  in  order  to  prepare  for  serious  cross-border  threats  to  health  is 
justified and proportionate compared to the damage and impact on society which can be significant in scale and can by 
far  exceed  the  financial  input.  The  additional  costs  would  also  be  justified  as  scientific  expertise  would  not  only  be 
provided for a given threat assessment, a sustainable network would also allow for capacity building and training in the 
area of chemical, biological and environmental threats.  

It is not expected that costs for coordination of improved risk management will rise as a similar meetings cycle for 
the new health group as in the present for the existing EWRS and Health security Committee will be maintained. 
Administrative budget for these meetings is available.  

As  regards  the  new reporting  requirements  0.3  Full  Time  Equivalent for  an  Administrator/Policy  Officer  for  the 
reporting  process  will  be  needed.  EUR  5,000-20,000  for  external  expertise  to  support  the  development  of  a 
questionnaire and the analysis of the replies by the Member States will be needed to implement the yearly reporting 
schemes. 

EUR 300,000-700,000 every five years for external and independent evaluation. The amount depends of the scope 
and details of the tender specifications for the evaluation. 

• 

• 

• 

Other Stakeholders/private companies:  

• 

It is not expected that private firms would have any obligations for alert reporting as such. As regards improved 
preparedness  and  business  continuity  in  private  sector  companies  it  is  worth  noting  that  in  particular  large 
companies have already engaged in putting in place business continuity planning at their own initiative; however, 

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there is no possibility and no intention to impose measures with financial implications.  

2. Access to medical countermeasures: 

With  regard  to  access  to  medical  countermeasures  option  3  would  aim  at  better  coordinating  the  procurement  of  medical 
countermeasures. As Member States would need to take provisions for such procurement anyway individually, a joint process 
would not lead to new financial commitments for the Member States. Increased administrative resources during the setting 
up period can be considered similar to what they would need to do anyway if they were to launch the procurement procedure 
alone individually. Once the joint procurement mechanism is operational, the overall administrative burden is expected to be 
less as compared to separated procurement at national level (example Austria/Vorarlberg).  

On the other hand, a joint procurement mechanism such as that already employed by the Pan American Health Organization 
would allow for benefits and generate savings resulting from stronger purchasing power, economies of scale, more attractive 
offers from suppliers and improved contract conditions for the Member States. Indeed, if the joint procurement is carried out 
by concluding advance purchase agreements before the actual need for the medical countermeasure arises, better contractual 
conditions will be obtained for the following reasons: 

- 

- 

in the absence of a health threat, the demand for the medical countermeasure is little. Even if the demand exceeds the 
current production capacity, suppliers have the time to expand production capacity to match the demand. The advance 
purchase agreements allow for forecasting the demand so that costly production under- or over-capacity can be avoided. 

the  security  of  having  advance  purchase  agreements,  even  if  at  less  favourable  conditions  for  the  supplier,  is  more 
attractive  for  a  supplier  than  the  insecurity  of  not  knowing  when  or  if  a  future  need  will  arise  ("a  bird  in  the  hand  is 
worth  2  in  the  bush").  The  security  of  advance  purchase  agreements  allows  the  supplier  to  discount  investments  for 
product development and maintenance of production capacity against revenue247 from advance purchase agreements. 

-  The increased size of the advance purchase agreements through joint procurement will generate economies of scale and 

will cause stronger competition between suppliers. 

In contrast, if joint procurement carried out when there is an acute need for a medical countermeasure will generate limited 
benefits, if any, because: 

- 

there is no time to make suppliers compete with each other 

247 

EN 

Such revenue can take the form of (1) fees to guarantee a reserved quantity of a medical countermeasure that can be delivered in the event of a health threat, (2) an advance 
purchase commitment (with payment of an advance) to buy a certain quantity of a medical countermeasure that will be delivered in the event of a health threat or (3) an 
advance purchase of a medical countermeasure to be stockpiled by the buyer or by the supplier. 

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- 

the high and acute demand for the medical countermeasure will result in a 'seller's market' where the demand is much 
higher than the offer. 

In terms of administrative costs, the Eco-procurement Service of Vorarlberg (Austria) has achieved savings up to 60%through 
joint procurement.  

Setting up a joint procurement is unique at the EU level, therefore the financial implication for the Commission can only be 
estimated on the work carried out so far. Increase in administration and in financial implications is expected during the setting 
up  of  the  proposed  mechanism.  These  effects  would  decrease  during  a  kind  of  routine  running  of  the  contract  prior  to  the 
emerging  pandemic.  Once  a  pandemic  is  declared,  it  would  require  the  activation  of  the  contract  and  lead  to  the 
administrative  needs  to  rise  steeply  for  a  short  period  of  time.  In  order  to  set  up  a  mechanism  for  joint  procurement  the 
financial  implications  would  –  based  on  the  current  experience  be  the  following:  2  Full  Time  Equivalent  at  AD  level,  in 
addition for meetings to consult with Member States EUR 150,000 and for external expertise on the matter external expertise 
to draft the tender specification EUR 25,000 will be requested. 

6. Administrative burden 

- 

For Member States 

Preparedness and response planning: There is a certain administrative burden for Member States to develop and implement 
core  capacity  standards  in  line  with  the  International  Health  Regulations,  the  additional  administrative  burden  to  define  in 
addition specific EU criteria can be considered as marginal.  

As regards notification and risk assessment: Member States are already obliged to notify health threats to the WHO under the 
International Health Regulations, to communicable diseases and to certain other threats under EU legislation. There will be a 
certain amount on administrative burden to establish links between these systems and review existing reporting mechanisms; 
however, this burden will decrease once the connections and links are made. Thus established efficiency will be gained and 
coherence  and  cooperation  between  reporting  tools  will  have  positive  effects  on  administrative  procedures,  they  will  be 
streamlined and double work will be avoided.  

Costs  induced  for  reporting  are  supposed  to  add  administrative  burden,  however  will  be  counterbalanced  by  improved 
reporting and information and hence better preparedness for future crises. 

Under this option governance would be significantly improved as only one expert group needs to be operated.  

As regards the newly established reporting and monitoring procedures to implement the improved health security framework 
Member  State  would  need  to  provide  0.3  –  0.5  Full  Time  Equivalent  for  a  national  expert  over  a  period  of  2-3  months  to 
address reporting. As Member States have also reporting duties under the International Health Regulations synergies in the 

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reporting can be expected. 

In addition, Member States would need to dedicate staff capacities very five years to contribute to an external evaluation. 

Increase in administrative burden would have to be expected during the setting up phase of the proposed mechanism for joint 
procurement, but for those Member States that envisage adequate provision and preventive measures for a future pandemic 
the administrative procedures have to be implemented any way. 

For the Commission 

The  Commission  is  already  committed  to  implement  preparedness  and  response  planning;  this  was  in  particular  done  to 
enhance pandemic preparedness, but efforts on generic preparedness were undertaken as well. With a more systematic and 
structured  approach  synergies  in  the  work  invested  by  Commission  staff  can  be  expected  and  no  additional  administrative 
burden. 

Additional  efforts  would  need  to  be  undertaken  by  improving  coordination  with  existing  crisis  notification  tools  and  alert 
mechanisms;  however,  as  contacts  to  these  instruments  are  already  in  place,  the  additional  investment  for  which  human 
resources  are  needed  can  be  considered  marginal.  This  additional  work  can  be  done  by  available  staff  and  assignment  to 
national experts. 

Governance for management would be significantly improved as only one expert group needs to be operated.  

Increase  in  administration  would  have  to  be  expected  during  the  setting  up  phase  of  the  proposed  mechanism  for  joint 
procurement  of  medical  countermeasures  in  form  of  additional  staff  and  administrative  burden  for  the  entity  in  charge  of 
operating the contract. (see details under financial implications). This task might be assigned to the Commission, there are 
however options that external support is requested for this task, e.g. by assigning this task to an Agency or Body in charge of 
procurement or contract management. 

These  administrative  effects would decrease  during  the  running  of  the contract  prior to  a  cross-border health  threat.  In  the 
case  of  an  outbreak  or  a  public  health  event  which  would  require  the  activation  of  the  contract,  the  administrative  needs 
would rise steeply: However, for the participating countries the proposed mechanism will result in a significant reduction of 
administrative burden as it would enable the pooling of different skills and expertise between national authorities. 

For other stakeholders/private companies: 

No additional administrative burden is expected 

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7. EU added value 

++ 

Under  option  3  EU  added  value  would  be  increased  throughout  all  elements  of  preparedness  and  response  planning,  risk 
assessment and risk management by setting up a strategic and technical level cooperation on health security at the EU level. 
This would be guaranteed by the establishment of a sound legal basis for all serious cross-border health threats. 

8.. Impact at International level 

++ 

In providing also a legal basis for operating a joint procurement mechanism for medical countermeasures it would add value 
to strengthening preparedness and response capacity to cross-border health threats across the EU. 

Better  coordination  in  the  EU  of  IHR  implementation  by  the  Member  States  and  closer  collaboration between  the  EU  and 
WHO on preparedness for and response to public health emergencies of international concern would contribute to enhance 
global health security. It would contribute to better control the spread of diseases internationally from and to the EU through 
e.g. through exchange of information and good practice with global partners and 3rd countries.  
In this context improved public health risk assessment and management could be undertaken more effectively at international 
level when the EU has defined a common approach on serious cross-border threats to health and pre-established procedures 
on international cooperation.  

The importance of the new EU expert group in the relation with other international entities (e.g. GHSI) would be significantly 
increased.  

In  addition,  improved  communication  strategies  at  EU  level  can  also  be  useful  and  shared  with  third  countries  and  other 
international partners and organisations. 

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Annex 20: Comparison of the policy options 

Rating:  

0 Baseline scenario, neutral impact 
+ positive impact; 
- negative impact; 

++ significant positive impact, 
-- significant negative impact, 

Assessment Criteria 

Option 1 
Status quo  

1. Improved protection of EU citizens against serious 
cross-border threats to health 
2. Improved public health security structures and systems 

2.1. Coherent and comprehensive overall approach for all 
serious cross-border threats to health  

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

2.3. Improved risk monitoring and assessment  
2.4. Improved coordination and risk management  

2.5. Improved crisis communication 
3. Social impacts 
4. Economic impacts 
5. Financial implications 
6. Administrative burden 
7. EU added value 
8. Impact at international level 
Total 

0 

0 

0 

0 
0 

0 
0 
0 
0 
0 
0 
0 
0 

Option 2 
improved 
cooperation by 
use of soft 
instruments- 
voluntary 
approach 
+ 

+ 

+ 

+ 
+ 

+ 
+ 
+ 
- 
0 
+ 
+ 
9 

Option 3 
Improved 
cooperation; 
legally 
binding 
measures 

++ 

++ 

++ 

++ 
++ 

++ 
++ 
++ 
- 
- 
++ 
++ 
18 

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Annex 21: 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 

2.  Public  health 
systems: 
Effectiveness248,  efficiency249  and  coherence250  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) 

2.2.  preparedness  and 
response  planning,  common 
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 

248 
249 
250 

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 

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d. equitable access to medical countermeasures 

2.3. risk monitoring and assessment: coherent and 
comprehensive approach for  

- 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 –  

- sustainable structure at EU level for any serious cross-
border public health crisis;  

- clear mandate for this structure with strong commitment 
of Member States 

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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Annex 22. Glossary: Public Health Security in the European Union 

Case definition 

For  the  scope  of  coordination  of  public  health  measures  during 
outbreak  (or  epidemic,  or  incidents,  or  pandemics)  Case  definition  is 
the  method  by  which  public  health  professionals  define  who  is 
included  as  a  case  in  an  outbreak  investigation,  (i.e.  a  person 
considered  directly  affected  by  an  outbreak)  or  in  the  surveillance  of 
public  health  conditions.  A  case  definition  has  the  following 
characteristics;  it  defines  a  case  in  time,  person  and  place.  Time 
criteria may include all cases of a disease identified from, for example, 
January  1,  2008  to  March  1,  2008.  Person  criteria  may  include  age, 
gender,  ethnicity,  and  clinical  characteristics  such  as  symptoms  (e.g. 
cough and fever), clinical tests (e.g. pneumonia on chest X-ray). Place 
criteria will usually include a geographical entity such as a town, state, 
or  country  but  may  be  as  small  as  an  institution,  a  school  class,  or  a 
restaurant meal session. Case definitions may also be categorised into 
suspect, probable and confirmed cases. 

For  example  in  the  investigation  of  an  outbreak  of  pneumococcal 
pneumonia in a nursing home the case definition may be specified as: 

Suspect  Case:  All  residents  of  Nursing  Home  A  with  onset  of  cough 
and fever between January 1, 2008 and February 1, 2008. 

Probable Case: Meet the suspect case definition plus have pneumonia 
on chest X-ray. 

Confirmed  Case:  Meet  the  probable  case  definition  plus  have 
pneumococcal infection confirmed by blood culture or other isolation 
of pneumococci from normally sterile site. 

By  creating  a  case  definition,  public  health  professionals  are  better 
equipped  to  study  an  outbreak  and  determine  possible  causes.  As 
investigations  proceed, this  definition  may  be  expanded  or  narrowed. 
This is characteristic of the dynamic nature of outbreak investigations. 

Core 
requirements  

capacity 

Core  capacity  requirements  refer  a  core  set  of  capacities,  structures, 
mechanisms, processes and procedures which need to be in place and 
available  for  preparedness  and  response  to  address  serious  cross-
border health threats in the EU. 

Crisis 
management 

involves 

Management  of  any  critical  situation  that  causes  a  disruption  to  the 
balance between the demand for and supply of medical services. Crisis 
management 
the  plans,  structures  and  arrangements 
established  to  bring  together  the  normal  endeavors  of  government, 
voluntary  and  private  agencies  in  a  comprehensive  and  coordinated 
way  to  deal  with  the  whole  spectrum  of  emergency  needs  including 
prevention, response and recovery. 

Crisis 
communication 

Communicating  in  a  situation  that  somehow  challenges  the  public’s 
sense of appropriateness, traditional values, safety, health, security or 

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the integrity of the government. 

Crisis 
management 
circle 

Preparedness  and  response  planning 
is  about  developing  and 
strengthening capacities to respond rapidly to any kind of emergencies 
affecting or likely to affect public health. 

Risk  assessment,  i.e.  independent  expertise  with  sound  scientific 
advice on emerging risks to public health, is needed to enable decision 
makers  to  prepare  their  policy  and  activities  relating  to  reinstalling 
public  health.  This 
the 
detection/alerting and monitoring/surveillance of emerging threats, the 
evaluation  of  potential  risks  to  public  health  coming  from  those 
threats, as well as the notification of such risks to concerned entities. 

assessment  process 

includes 

risk 

Risk management covers the sum of the decisions and actions taken by 
competent  authorities  during  and  after  a  crisis.  Risk  management 
including 
the  whole  spectrum  of  emergency  needs 
includes 
prevention,  response  and  recovery.  These,  for  example  cover  the 
diagnosis of cases by specialised laboratories, providing medical care 
if necessary even in mobile units, vaccination, containment of people, 
travel  advice,  rules  on  personal  protection  and  hygiene,  or 
decontamination  measures.  Efficient  communication  has  become  an 
important part of risk management. 

Developing  and  strengthening  capacities  to  respond  rapidly  to  any 
kind of emergencies affecting or likely to affect public health. 

the 

responsible 

A  written  document  or  map  for  public  health  crisis  management 
authority.  The  organisation, 
published  by 
responsibilities and measures are defined - with details on how, when 
and  whom  -  both  before  and  after  an  event  with  public  health 
consequences occurs. It aims to provide a policy for preparedness and 
response  to  both  internal  and  external  disaster  situations  that  may 
affect the population and the community. 

Crisis 
preparedness  and 
response 
planning 

Crisis 

preparedness 

plan 

is 

Preparedness 
the  knowledge  and  capacities  developed  by 
government,  organisations  and  communities  to  effectively  anticipate, 
respond  to,  and  recover  from,  the  impacts  of  a  likely,  imminent  or 
current crisis. 

Critical 
infrastructures 

Critical infrastructures are those physical and information technology 
facilities,  networks,  services  and  assets  which,  if  disrupted  or 
destroyed, would have a serious impact on the health, safety, security 
or  economic  well-being  of  citizens  or  the  effective  functioning  of 
governments in EU countries. 

Cross-sectoral 
action 

Interdisciplinary, collaborative activity that is carried on with the help 
and/or involvement of several sectors at the same time. 

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Health 

measure 

Procedures applied to prevent the spread of disease or contamination; 
a  health  measure  does  not  include  law  enforcement  or  security 
measures. 

Health security 

to  minimise 
Activities  required,  both  proactive  and  reactive, 
vulnerability to acute public health events that endanger the collective 
health  of  populations 
living  across  geographical  regions  and 
international boundaries. 

IHR (2005) 

- 

IHR 

(2005): 

International  Health  Regulations 
the  WHO 
international  regime  providing  global  rules  to  enhance  national, 
regional  and  global  public  health  security.  This  legally-binding 
agreement significantly contributes to global public health security by 
providing  a  new  framework  for  coordinating  the  management  of 
events that may constitute a public health emergency of international 
concern, and improves the capacity of all countries to detect, assess, 
notify and respond to public health threats (www.who.int/ihr/en/). 

IHR 
Annex 2 

(2005) 

The  annex  2  of  the  IHR  (2005)  is  a  decision  instrument  for  the 
assessment  and  notification  of  events  that  may  constitute  a  public 
health  emergency  of  international  concern.  It  is  available  under: 
http://whqlibdoc.who.int/publications/2008/9789241580410_eng.pdf. 

Interoperability 

Property  referring  to  the  ability  of  diverse  sectors,  disciplines  or 
organisations to work together. 

Joint 
procurement  

Two  or  more  contracting  authorities  joining  their  public  procurement 
actions. 

Quarantine 

Restriction  of  activities  and/or  separation  from  others  of  suspect 
persons who are not ill or of suspect baggage, containers, conveyances 
or  goods  in  such  a  manner  as  to  prevent  the  possible  spread  of 
infection or contamination. 

Real events in the 
past 

Some examples: Influenza A(H1N1) pandemic in 2009, Severe Acute 
Respiratory  Syndrome  (SARS),  milk  contaminated  with  melamine, 
food  contaminated  with  dioxin,  stainless  steel  contaminated  with 
cobalt-60. 

Response 

Risk 
assessment 

Sum of public health decisions and measures taken during and after a 
disaster, including immediate relief, rehabilitation and reconstruction. 

A  scientifically  based  process  consisting  of  the  following  steps:  (i) 
threat  detection  and  identification,  (ii)  threat  characterisation,  (iii) 
exposure assessment, and (iv) risk characterisation. 

Risk 
communication 

The  exchange  and  dissemination  of  appropriate  information  about 
risks to enable decision makers, stakeholders and the public to make 
appropriate decisions. 

Risk 

A  process,  distinct  from  risk  assessment,  of  weighing  policy 

EN 

130 

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management 

alternatives,  in  consultation  with  interested  parties,  considering  risk 
assessment  and  other  factors  relevant  for  health  protection  of 
consumers, and if needed selecting appropriate prevention and control 
options. 

Serious 
border 
health threat 

cross-
public 

of 

Stockpile 
medical 
countermeasures 

An  event  of  biological,  chemical,  radiological  and  nuclear  or 
environmental  origin  or  caused  by  climate  change,  with  potentially 
severe  consequences  for  public  health  which  affects  or  could  affect 
more  than  one  Member  State  in  such  a  way  that  the  morbidity  or 
mortality  in  humans  is  acute  and  rapidly  growing  in  scale  or  is 
unusual for the given place and/or time. 

A supply of medical countermeasures stored for future use against a 
health threat. 

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Annex 23: Reference Documents and Links 

Health Security Committee (HSC) 

Presidency  conclusions  of  15  November  2001  on  bioterrorism  -  Informal  cooperation  and 
coordination  body  by  Health  Ministers  and  the  European  Commissioner  for  Health  and 
Consumer Protection 2384th Council meeting 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/DOC.68699.htm 
http://europa.eu/rapid/pressReleasesAction.do?reference=PRES/01/415&format=HTML&age
d=0&lg=nl&guiLanguage=en 
What is the Health Security Committee? - What is the Early Warning and Response System 
(EWRS)? MEMO/09/363 
http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/09/363&type=HTML 
Council conclusions of 5 February 2007 on the Communication from the Commission to the 
Council on the transitional prolongation and extension of the mandate of the HSC in view of a 
future general revision of the structures dealing with health threats at EU level - in 2007, the 
Council  agreed  that  the  mandate  of  the  HSC  was  temporarily  prolonged  covering  also 
pandemic influenza and generic preparedness and response planning and the general revision 
of the structures dealing with health threats at EU level (5862/07). 
Council  conclusions  of  22  February  2007  on  Health  Security  Committee  -  Transitional 
prolongation of the HSC mandate and extension of Terms of reference for the HSC; request 
for long-term solution for the EU framework on health security 2786th Council Meeting 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf 
Council conclusions of 16 December 2008 on health security (after informal Health Ministers 
meeting  Angers,  8-9  September  2008)  -  Provide  HSC  with  legal  basis  and  Legislative 
initiative to adopt the status of HSC to the health challenges 2916th Council meeting 
http://www.consilium.europa.eu/ueDocs/cms_Data/docs/pressData/en/lsa/104770.pdf 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/104835.pdf 
http://register.consilium.europa.eu/pdf/en/08/st16/st16515.en08.pdf 
Council  conclusions  on  lessons  learned  from  the  A/H1N1 pandemic  -  health  security  in  the 
European Union of 13 September 2010 - present in 2011 a proposal for health security and 
further prolong the current HSC mandate 3032nd Council meeting 
http://ec.europa.eu/health/preparedness_response/docs/council_lessonsh1n1_en.pdf 
Health Security Initiative  
Communication  of  2  June  2003  from  the  Commission  to  the  Council  and  the  European 
Parliament on cooperation in the European Union on preparedness and response to biological 
and chemical agent attacks (Health Security) COM(2003) 320 final 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2003:0320:FIN:EN:PDF 
Communication  of  28  November  2005  from  the  Commission  to  the  Council,  the  European 
Parliament,  …  on  strengthening  coordination  on  generic  preparedness  planning  for  public 
health emergencies at EU level COM(2005) 605 final 
http://eur-lex.europa.eu/LexUriServ/site/en/com/2005/com2005_0605en01.pdf 
Commission  Staff  Working  Document  of  23  November  2009  on  Health  Security  in  the 
European  Union  and  Internationally.  The  health  security  concept  is  about  our  society's 
vulnerability to major public health threats and about mitigating such threats. To set out the 
current  EU  policy  framework  in  the  area,  the  Commission  has  analysed  how  to  deal  with 
major public health threats and published a Commission Staff Working Document SEC(2009) 
1622 final 
http://ec.europa.eu/health/preparedness_response/docs/commission_staff_healthsecurity_en.p
df 

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Commission  Staff  Working  Document  of  18  November  2010  on  lessons  learnt  from  the 
H1N1 pandemic and on health security in the European Union. The health security initiative 
was  requested  by  the  EU  Council,  in  its  conclusions  adopted  on  13  September  2010  on 
lessons  learned  from  the  A/H1N1  pandemic  -  health  security  in  the  European  Union.  The 
principles  for  the  initiative  were  set  out  in  the  Commission  Staff  Working  Document 
SEC(2010) 1440 final 
http://ec.europa.eu/health/preparedness_response/docs/commission_staff_lessonsh1n1_en.pdf 
Communicable diseases  
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 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:268:0001:0006:EN:PDF 
Early Warning and Response System (EWRS)  
Commission  Decision  No  2000/57/EC  of  22  December  1999  on  the  early  warning  and 
response  system  for  the  prevention  and  control  of  communicable  diseases  under  Decision 
2119/98/EC of the European Parliament and the Council  
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/14517.en0.doc.html 
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2000D0057:20090714:EN:PDF 
European Centre for Disease Prevention and Control (ECDC)  
Regulation (EC) No 851/2004 of the European Parliament and the Council of 21 April 2004 
establishing a European centre for disease prevention and control 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:142:0001:0011:EN:PDF 
Pandemic Influenza  
Communication of 28 November 2005 from the Commission to the European Parliament and 
the  Council  on  Pandemic  Influenza  Preparedness  and  Response  Planning  in  the  European 
Community COM(2005) 607 final 
http://eur-lex.europa.eu/LexUriServ/site/en/com/2005/com2005_0607en01.pdf 
Communication of 15 September 2009 from the Commission to the European Parliament and 
the Council on Pandemic (H1N1) 2009 COM(2009) 481 final 
http://ec.europa.eu/health/ph_threats/com/Influenza/docs/com481_2009_en.pdf 
Accompanied by SEC(2009) 1188 / 1189 / 1190 / 1191 / 1192  
Commission  Staff  Working  Document  of  15  September  2009  on  Joint  procurement  of 
vaccine against influenza A(H1N1) SEC(2009) 1188 final  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2009:1188:FIN:EN:PDF 
Commission  Staff  Working  Document  of  15  September  2009  on  Vaccination  strategies 
against pandemic (H1N1) 2009 SEC(2009) 1189 final  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2009:1189:FIN:EN:PDF 
Commission  Staff  Working  Document  of  15  September  2009  on  Communicating  with  the 
public and the media on Pandemic (H1N1)2009 SEC(2009) 1190 final  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2009:1190:FIN:EN:PDF 
Commission Staff Working Document of 15 September 2009 on Regulatory process for the 
authorisation of antiviral medicines and vaccines in the protection against Pandemic Influenza 
(H1N1) 2009 SEC(2009) 1191 final  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2009:1191:FIN:EN:PDF 
Commission Staff Working Document of 15 September 2009 on Support to third countries to 
fight the Influenza A(H1N1) SEC(2009) 1192 final  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2009:1192:FIN:EN:PDF 
International Health Regulations (IHR) 

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(2005),  Second  edition,  Authors:  World  Health 

Communication of 26 September 2006 from the Commission to the European Parliament and 
the Council on the International Health Regulations COM(2006) 552 final 
http://ec.europa.eu/health/ph_international/documents/comm_ihr_552_2006_en.pdf 
International  Health  Regulations 
Organization (WHO), Publication date: 2008, ISBN: 9789241580410 
http://www.who.int/ihr/9789241596664/en/index.html 
Home Affairs – Action Plan CBRN 
Communication of 24 June 2009 from the Commission 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 
http://ec.europa.eu/home-affairs/summary/docs/com_2009_0273_en.pdf 
Accompanied by SEC(2009) 790 / 791 / 874 
Commission  Staff  Working  Document  of  24  June  2009  on  Strengthening  Chemical, 
Biological,  Radiological  and  Nuclear  Security  in  the  European  Union.  Impact  Assessment 
SEC(2009) 790 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2009:0790:FIN:EN:PDF 
Commission  Staff  Working  Document  of  24  June  2009  on  Strengthening  Chemical, 
Biological, Radiological and Nuclear Security in the European Union. Summary of the Impact 
Assessment SEC(2009) 791 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2009:0791:FIN:EN:PDF 
Council conclusions on strengthening chemical, biological, radiological and nuclear (CBRN) 
security in the European Union – an EU CBRN Action Plan  
http://register.consilium.europa.eu/pdf/en/09/st15/st15505-re01.en09.pdf 
Climate Change 
The Commission has adopted in 2009 a White Paper on "Adapting to climate change: 
Towards a European framework for action" and a communication on climate change 
COM(2009) 147 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0147:FIN:EN:PDF 
Commission  Staff  Working  Document  of  1  April  2009,  accompanying  document  to  the 
WHITE PAPER "Adapting to climate change: Towards a European framework for action", on 
Human, Animal and Plant Health Impacts of Climate Change SEC(2009) 416 
http://ec.europa.eu/health/ph_threats/climate/docs/com_2009-147_en.pdf 

APPENDICES  

1.  Report  on  the  outcome  of  the  "Stakeholder  consultation  on  Health  Security  in  the 
European Union" 

2011 10 17 HSI 
consult stakeholder co 

2. Structures for preparedness and response to cross-border health threats 

Appendix 
3_Structures for prep 

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