COMMISSION STAFF WORKING PAPER EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
Date: 2011-12-08
Institutions: European Commission
Subjects: cross-border cooperation, external border of the EU, health care, health control, infectious disease, right to health, therapeutics

EUROPEAN COMMISSION 

Brussels, 8.12.2011 
SEC(2011) 1520 final 

COMMISSION STAFF WORKING PAPER 

EXECUTIVE SUMMARY OF THE 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) 1519 final} 

 
 
 
 
  
 
1. 

THE HEALTH SECURITY INITIATIVE 

The  aim  of  the  Health  Security  Initiative  is  to  streamline  and  strengthen  health  security 
capacities  and  structures  in  order  more  effectively  to  protect  the  citizens  of  the  European 
Union (EU) against serious cross-border threats that can affect public health. 

The EU has a well established policy and legal framework to address communicable diseases 
that  has  been  in  place  since  1998.  It  sets  out  legal  requirements  for  the  surveillance  of 
communicable  diseases,  the  notification  of  acute  events  at  EU  level  through  a  secure  Early 
Warning  and  Response  System  (EWRS)  and  the  exchange  of  information  on  public  health 
measures taken to control such outbreaks. Member States are therefore under the obligation to 
notify  outbreaks  of  communicable  diseases.  Information  on  such  diseases  is  shared  in  real 
time with all Member States, and measures to address them are coordinated at EU level. Since 
2005,  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC)  provides  scientific 
risk assessment on communicable diseases. 

However,  not  all  serious  cross-border  threats  to  health  are  handled  in  such  a  consistent 
manner  at  EU  level.  The  Health  Security  Initiative  therefore  aims  to  provide  a  comparable 
level  of  protection  against  other  types  of  serious  cross-border  threats  to  health  caused  by 
biological,  chemical  and  environmental  events.  The  specific  nature  of  these  threats  will  be 
taken into consideration. 

The  Health  Security  Initiative  will  also  help  implement  the  European  Health  Strategy  and 
contribute  to  the  objectives  of  Europe  2020  by  promoting  health  as  an  integral  part  of  the 
smart and inclusive growth objectives. In addition, it will contribute to the overall European 
security  effort  and  in  particular  help  achieve  the  agenda  set  out  in  the  Internal  Security 
Strategy.  The  initiative  will  also  be  instrumental  in  strengthening  chemical,  biological, 
radiological and nuclear (CBRN) security in the EU as set out in the CBRN action plan and 
stepping  up  cooperation  with  the  Monitoring  and  Information  Centre  mechanism  in 
preparedness for and response to civil disasters. 

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 component1.  

In  the  context  of  this  initiative,  serious  cross-border  threats  to  health  are  events  caused  by 
communicable  diseases,  or  by  biological  agents  causing  non-communicable  diseases,  of 
chemical,  environmental  or  unknown  origin,  or  caused  by  climate  change,  with  potentially 
severe  consequences  for  public  health.  For  the  purposes  of  the  initiative,  threats  emerging 
from  the  effects  of  climate  change  will  be  covered  by  environmental  threats.  Radiological 
events  are  excluded  from  the  initiative  as  they  are  dealt  with  under  the  provisions  of  the 
Euratom Treaty. 

1 

E.g. 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  this 
initiative to create regional CBRN Centres of Excellence.  

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The scope of the initiative will cover the EU-level coordination of preparedness and response 
planning  for  these  threats  to  health,  including  the  procurement  of  medical  countermeasures, 
monitoring  and  assessment  of  the  risks  to  public  health  arising  from  these  potential  threats 
and management and communication of the identified risks and health-related crises. 

The initiative  was  developed following an extensive consultation process including an open 
stakeholder consultation on health security in the European Union, several meetings with the 
Early  Warning  and  Response  System  (EWRS)  network  and  the  Health  Security  Committee 
(HSC)2, bilateral meetings with six Member States and a presentation to the EU Health Policy 
Forum.  The  outcome  of  the  open  consultation  process  on  ‘strengthening  European  Union 
preparedness  on  pandemic  influenza’  from  2010  was  also  taken  on  board.  Relevant 
Commission  departments  have  been  involved  in  developing  the  initiative,  including  the 
Secretariat-General. 

2. 

PROBLEM DEFINITION 

2.1. 

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

Member States are differently equipped to respond to serious cross-border health threats with 
regard to laboratory infrastructure, analytical tools or staff levels, for instance. Moreover, not 
all the critical sectors in society are thoroughly prepared for a wide range of events that may 
have an impact on public health. Member States and critical sectors that are less well prepared 
will  weaken  and  delay  the  EU  response  and  adversely  impact  on  the  situation  in  other 
Member States. 

In the event of an emergency, a wide range of public health measures may be necessary, for 
example  the  diagnosis  of  cases  by  specialised  laboratories,  the  provision  of  medical  care, 
vaccination  or  treatment,  travel  advice,  rules  on  personal  protection  and  hygiene,  or 
decontamination  measures.  Apart  from  health,  other  critical  sectors  need  to  be  prepared. 
Hospitals, for example, cannot function properly if electricity fails or if doctors are unable to 
travel to work due to the breakdown 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  fall 
sick. 

Discrepancies  in  the  level  of  preparedness  planning  across  the  EU  may  lead  to  incoherent 
strategies, divergent standards, and inconsistent procedures and methodologies. They may, for 
example,  entail  unequal  access  to  treatment  and  medical  care,  endanger  management  of 
outbreaks, and even lead to an increase in the number of people falling sick or dying. Without 
coordination  at  EU  level,  Member  States  may  adopt  different  mutually  counterproductive 
measures  e.g.  as  regards  closing  borders,  imposing  quarantine  or  issuing  travel  advice,  and 
public health measures will be managed on an ad hoc basis by individual Member States. Risk 
management at EU level will be less effective and public trust in national authorities and in 
EU institutions will be undermined. Ultimately this may lead to major repercussions on other 
EU policies, not least the functioning of the internal market. 

Individual  procurement  of  medical  countermeasures  may  increase  competition  between 
Member  States.  Confidentiality  clauses  in  contracts  may  considerably  weaken  Member 

2 

The name of this body might be changed in the legal proposal.  

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States’ purchasing power and, when combined with restrictions on health budgets, may lead 
to  procuring  insufficient  amounts  of  medical  countermeasures,  thereby  considerably 
weakening EU preparedness. 

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 

Although there are a variety of monitoring and alert systems for different threats at EU level, 
these are not systematically linked to EU public health institutions. 

The International Health Regulations (IHR) — an international treaty for the coordination of 
all  health  emergencies  —  stipulate  that  Member  States  must  notify  the  World  Health 
Organisation  (WHO)  about  any  event  that  may  constitute  a  public  health  emergency  of 
international concern, independently of its origin (biological, chemical, radiological, nuclear 
or environmental). 

There are no similar notification obligations at EU level. What is more, 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,  which  necessitate  a 
more sensitive system. 

National public health  risk assessments exist, but may not be comprehensive and consistent 
when  considered  from  the  EU  perspective,  and  there  is  currently  no  mechanism  for  a 
coordinated approach at EU level. The lack of public health risk assessment at EU level leads 
to  discrepancies  in  evaluating  the  danger  of  a  given  threat,  duplication  of  assessments 
between Member States and incoherent measures at EU level. Such a situation can also lead 
to inefficient use of the limited resources currently available and may delay appropriate public 
health  measures,  thereby  potentially  putting  at  risk  the  overall  response  at  EU  level.  The 
adverse  impact  of  this  situation  might  result  in  higher  levels  of  morbidity  and  mortality.  It 
may also endanger shared EU policies because of the impact of health effects on other critical 
sectors of the economy and society. Importantly, the absence of comprehensive or proper risk 
evaluation  may  lead  to  unclear  communication  and  may  undermine  public  confidence  in 
measures proposed or taken by public health authorities in Member States. 

2.3. 

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

Serious  cross-border  health  threats  are  unavoidable.  They  do  not  happen  as  frequently  as 
communicable  diseases,  but  they  can  have  huge  consequences  both  for  health  and  for  other 
sectors of the society and economy. The basis for coordinating the public health response at 
EU  level  is  weak  compared  with  the  potential  impacts.  The  structures  and  mechanisms  for 
public  health  risk  management  at  EU  level  are  not  tailored  to  the  new  international  legal 
framework  (the  International  Health  Regulations)  and  are  inadequate  to  deal  with  a  health-
related crisis. 

In  addition,  the  respective  mandates,  responsibilities  and  scope  for  taking  decisions  on  the 
public health response are not clearly differentiated between the two existing bodies, namely 
the  Early  Warning  and  Response  System  (EWRS)  network  and  the  Health  Security 
Committee (HSC). This informal committee was set up by the EU health ministers in 2001 in 

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the aftermath of the terrorist attacks, as a structure for better coordinating public health risk 
assessment  and  management  of  serious  cross-border  health  threats  in  the  EU.  At  the 
beginning, its mandate was limited to tackling bioterrorism; it was subsequently extended to 
cover  all  types  of  public  health-related  crisis  and  further  prolonged.  It  is  composed  of 
representatives of health authorities of the Member States and chaired by the Commission. 

Given  the  informal  nature  of  the  Committee  and  its  ad  hoc  mandate,  there  is  insufficient 
coordination  of  the  public  health  response  and  no  cross-sectoral  interlinking  of  decision 
making  processes  in  public  health.  Even  shared  statements  on  minimum  common 
denominators are difficult to achieve without a robust framework, leading to the risk of delays 
in  the  response  to  health  emergencies.  Although  a  Communicators’  network  has  been 
established  under  the  Health  Security  Committee,  the  lack  of  a  formal  mechanism  for 
agreeing  consistent  messages  to  the  public  and  target  populations  is  not  conducive  to  an 
efficient information process at EU level. This undermines the confidence in and credibility of 
the  public  health  response  to  chemical,  biological  (other  than  communicable  diseases)  and 
environmental threats. 

3. 

THE RIGHT OF THE UNION TO ACT 

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  the  protection  and 
improvement of human health (Article 6(a) TFEU). The Treaty states that EU action must be 
directed  towards  improving  public  health,  preventing  physical  and  mental  illness  and 
diseases,  and  obviating  sources  of  danger  to  physical  and  mental  health,  and  in  particular 
‘monitoring,  early warning of and combating serious cross-border threats to  health’ (Article 
168 TFEU). 

‘Serious  cross-border  threats  to  health’  as  defined  in  the  Treaty  and  ‘public  health 
emergencies  of  international  concern’  as  defined  under the International  Health  Regulations 
have,  by  their  nature,  transnational  implications  which  Member  States  cannot  satisfactorily 
address individually. They often affect crucial sectors of the economy and society. Many of 
these  sectors  fall  under  exclusive  or  shared  EU  competence,  and  therefore  require  the 
involvement of different stakeholders. 

The EU already has good experience of coordination in the field of communicable diseases, 
which  is  governed  by  a  comprehensive  body  of  EU  legislation  and  has  proved  essential  in 
handling serious outbreaks in Europe. The Health Security Initiative will build on this positive 
experience, as well as on the existing instruments and lessons learnt. Because not all Member 
States have the same level of preparedness, risk assessment and crisis management, the Health 
Security Initiative will improve the coordination  of  the  management  of  serious  cross-border 
health threats at all levels. Member States’ preparedness will be strengthened by establishing 
common  procedures  and  standards,  sharing  resources,  and  improving  the  exchange  of 
expertise and information. Capacities for rapid and efficient response will be reinforced, and 
effective  coordination  of  the  management  of  serious  cross-border  health  threats  will  be 
ensured.  Access  to  and  availability  of  medical  countermeasures  will  be  better  balanced 
between  Member  States.  Strengthened  coordination  at  EU  level  will  lead  to  a  coherent  and 
comprehensive approach to risk assessment and management. This initiative will also provide 
the  EU  Member  States  with  an  opportunity  to  coordinate  their  action  in  implementing  the 
International Health Regulations. 

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4. 

POLICY OBJECTIVES 

Given the problems identified in Section 2, the health security initiative aims to achieve the 
objectives set out in the table below. 

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Table 1: Objectives of the Health Security Initiative 

General objectives 

More effectively protect the citizens of the European Union against serious cross-border threats to health and ensure a high level of human health protection in framing and 
implementing EU policies and activities 

Specific objectives 

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, and risk management, including risk communication 

Preparedness and response planning 

Risk monitoring and assessment 

Risk management and crisis communication 

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, including improving equitable access to 
medical countermeasures 

Create the necessary conditions to ensure the 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 

coordination 

among  Member 

-  Create  the  necessary  conditions  to  strengthen  and 
States, 
enhance 
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 
-  Create  and 
shared  and  coordinated 
facilitate 
communication strategies in order to avoid conflicting or 
inaccurate messages being released to the public 

Preparedness and response planning 

Risk monitoring and risk assessment 

Risk management and crisis communication 

Operational objectives 

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

interlink  and  ensure 

-  Strengthen,  better 
the 
sustainability  of  existing  monitoring  and  notification 
mechanisms and structures 
-  Strengthen  and  create  capacities  for  public  health 
risk  assessment  that  is  robust,  reliable,  compatible 
between sectors, and rapidly available  
-  Provide  mechanisms  for  reinforced  coordination 
among  existing  structures  for  serious  cross-border 
health threats other than communicable diseases 

- Strengthen the capacities and processes and establish a 
sustainable  structure/body  for  coordinating  the  public 
health  response  at  EU  level  to  any  cross-border  public 
health crisis 
-  Clearly  define  the  scope  of  the  activities  of  this 
structure/body  and  give  it  a  strong  mandate  for  EU  risk 
management,  with  a  strong  commitment  from  Member 
States 
-  Strengthen  measures  related 
to  risk  and  crisis 
communication  on  health  threats,  and  provide  for  rapid 
exchange  and  agreement  on  communication  messages 
and strategies 

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5. 

POLICY OPTIONS 

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  measures  identified  in  each  option  vary  according  to  the  level  of  implementation  of 
preparedness planning and core capacity requirements and the level of obligation on Member 
States in terms of implementation, the informal or formal nature of the expertise 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. 

A summary of the measures related to the three options is attached in Table 3 in the Annex. 

6. 

ANALYSIS OF THE IMPACTS 

6.1. 

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

Under this option the current situation including the problems described in Section 2 would 
remain unchanged. 

6.2. 

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 

Public health impact. The impact on public health would be improved as the overall situation 
in  terms  of  preparedness  for  and  response  to  a  crisis  would  be  strengthened  along  with  the 
effectiveness, efficiency and coherence of public health security structures and mechanisms. 
This  would  be  achieved  through  EU-wide  recommendations  supported  by  Member  States. 
However,  these  positive  impacts  would  rely  on  the  commitment  of  the  Member  States  to 
agree  on  these  recommendations  and  implement  them  on  a  non-binding  basis.  To  a  certain 
extent,  this  option  could  lead  to  increased  coherence  of  overall  preparedness,  improved 

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coordination  of  existing  notification  tools  and  strengthened  risk  assessment  capacities.  The 
risk  management  structures  supporting  the  coordinated  response  at  EU  level  would  be 
sustainable  with  clearer  mandates,  thereby  improving  the  effectiveness  of  health  crisis 
management, 
to  medical 
including  communication.  Regarding  equitable  access 
countermeasures,  the  impact  of  this  option  is  expected  to  be  an  improvement  on  individual 
national procurement procedures. However, the proposed activities would remain at the level 
of  cooperation  between  individual  authorities  in  charge  of  procurements,  and  purchasing 
power and the ability to obtain better contractual conditions would remain weak at best. 

Social  impact.  Provided  that  the  Member  States  implement  the  agreed  guidance  and 
recommendations,  improved  risk  management  and  in  particular  better  coordination  of  risk 
communication  would  have  a  beneficial  effect  on  citizens  as  messages  issued  to  the  public 
would be more consistent within the EU, thereby boosting confidence in the ability of public 
health  authorities  to  manage  a  health  crisis.  Inter-sectoral  cooperation  to  improve  public 
health  protection  would  be  strengthened.  As  regards  equitable  access 
to  medical 
countermeasures, this option would enable expertise to be pooled among the Member States 
and solidarity to be improved in terms of preparation of the procurement procedures. 

Economic  impact.  Option  2  could  lead  to  more  rapid  risk  assessment  and  management  of  a 
given threat. These improved structures and systems at EU level would result in strengthened 
capacities to contain and mitigate a serious cross-border health threat and its related economic 
consequences. As a result, 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 commitment of the Member States. Option 2 could positively impact 
on  innovation  and  R&D  efforts  related  to  the  development  of  such  products.  However,  this 
would not ensure improved access to medical countermeasures. 

Financial implications. No additional costs would arise for Member States and stakeholders, 
because the financial situation would be the same as described in option 1. 

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 — the 
Early Warning and Response System Network and the Health Security Committee — would 
be  clearly  defined,  thereby  limiting  the  risks  of  overlap.  As  regards  access  to  medical 
countermeasures,  the  administrative  burden  could  also  be  reduced  for  Member  States,  as 
national expertise would be pooled. 

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

6.3. 

Option  3:  Establish  a  common  EU  legal  framework  covering  all  serious  cross-
border health threats 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 
mechanisms  at  EU  level  would  be  considerably  improved.  This  would  allow  coherent 
preparedness  planning  based  on  shared  and  common  mandatory  standards  and  a  better 
coordinated  and  balanced  response  to  all  types  of  serious  cross-border  health  threats.  For 
example, all Member States would need to have preparedness plans in place that would cover 
both health measures and other critical sectors, and structures and capacities would need to be 

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set up in compliance with agreed check lists. This option would also result in a more coherent 
and  comprehensive  approach  to  the  identification,  notification  and  assessment  of  serious 
cross-border health threats. By setting up a legal basis allowing joint procurement, this option 
would considerably improve equitable access to medical countermeasures by Member States, 
thereby  ensuring  a  higher  level  of  protection  of  EU  citizens  across  the  Union.  Furthermore, 
inter-sectoral cooperation would be improved in the event of cross-border health threats, also 
contributing to better public health protection. 

Social  impact.  Along  with  the  impacts  related  to  improved  coordination  of  communication 
already identified for option 2, a coordinated approach to access to medical countermeasures 
would  raise  confidence  in  measures  undertaken  by  public  health  authorities,  as  they  would 
rely  on  a  robust  legal  instrument.  For  those  Member  States  that  had  opted  to  participate  in 
joint  procurement,  the  mechanism  would  lead  to  a  higher  level  of  protection  for  vulnerable 
groups by ensuring a guaranteed supply and would promote solidarity between the Member 
States by providing common minimum coverage for vulnerable groups of society. 

Economic  impact.  The  positive  impacts  already  described  under  option  2  could  increase, 
because  the  planned  measures  under  option  3  would  be  based  on  binding  agreements.  The 
setting-up  of  a  joint  procurement  mechanism  for  medical  countermeasures  would  boost  the 
supply of medical products and encourage development of new products based on long-term 
contracts agreed with the public health sector. 

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

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

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 cooperation on health security at EU level. This would be guaranteed 
by the establishment of a robust legal instrument for all serious cross-border health threats. By 
also  providing  a  legal  basis  for  operating  a  joint  procurement  mechanism  for  medical 
countermeasures  this  option  could  add  value  to  strengthening  preparedness  and  response 
capacity to deal with cross-border health threats across the EU. 

Impact  at  international  level.  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 enhancing 
global health security. 

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7. 

COMPARING THE IMPACTS 

Table 2: Comparison of the policy options 

Rating: 
+ 
- 

0 
positive impact 
negative impact 

Baseline scenario, neutral 

++ 
-- 

significant positive impact 
significant negative impact 

Assessment criteria 

Option 1  Option 2  Option 3 

1  Improved  protection  of  EU  citizens  against  serious  cross-border 
threats to health 

0 

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 

+ 

+ 

9 

++ 

++ 

++ 

++ 

++ 

++ 

++ 

++ 

- 

- 

++ 

++ 

18 

This comparison focuses on options 2 and 3, where new impacts can be expected. 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  also  establishes  common  mandatory  standards 
that  would  lead  to  considerably  improved  coordination  at  EU  level.  Both  options  also 
strengthen  risk  notification  and  assessment.  However,  option  3  would  provide  for  a  more 
coherent and comprehensive approach as a coordination system would be put in place. Risk 
assessment capacities would be improved by filling gaps in current risk assessment capacities 
under option 3. For risk and crisis management, option 2 would improve the overall situation 
as the mandates of the two committees would be clarified. However, option 3 would merge 

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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. 

8. 

CONCLUSIONS AND PROPOSAL FOR IMPLEMENTATION 

Option  3  has  the  strongest  health  impacts  as  it  provides  improved  protection  of  citizens 
against serious cross-border health threats. 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 to address all types of public health event by merging the two 
existing committees. 

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

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  and  extend  them  to  health  threats 
caused by biological, chemical and environmental events. 

9. 

MONITORING AND EVALUATION 

Systematic  follow-up  of  the  policy  measures  in  the  field  of  preparedness  and  response 
planning,  risk  assessment  and  risk  management  will  be  ensured  by  evaluating  the 
implementation of the legislative instrument. 

The  Commission  will  submit  to  the  European  Parliament  and  the  Council  regular  reports 
evaluating  the  implementation  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, WHO and EMA. The reporting system will be 
approved and implemented by the new committee. 

A more detailed inventory of existing capacities, measures and plans in terms of preparedness, 
risk assessment and risk management and communication 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  refined  and  serve  as  the  benchmark  against  which  progress  will  be 
measured after approval of the legal initiative. 

10. 

ANNEX 

Table 3: Overview of measures proposed under the three options 

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ANNEX: Table 3: Overview of measures proposed under the three options 

Option 1: Status quo 

Option 2: Soft instruments  

Preparedness and 
response planning 

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

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

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)  

Ditto option 1, plus: 
increase support for the Innovative 
Medicines Initiative and/or EU stockpile 
of medical countermeasures, 
better exchange of information on 
contractual conditions 
Recommendation to Member States 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 committee  

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 features 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 action, in particular joint procurement of 
medical countermeasures 
Develop common communication strategies, integrate communicators into 
the crisis management process and link communicators directly to risk 
managers/decision makers 

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