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}  
 
EN 2   EN This Impact Assessment report commits only the Commission’s servic es involved in its 
preparation and the text is prepared as a basis for comment and does not prejudge the 
final form of any decision to be taken by the Commission.
 
EN 3   EN TABLE OF CONTENTS 
1. Purpose and scope ........................................................................................................ 5 
2. Procedural issues and consultation of third parties ...................................................... 7 2.1. Consultation and expertise ........................................................................................... 7 2.2. The Impact Assessment Board..................................................................................... 8 3. Policy context in the area of health security ................................................................ 9 3.1. The Health security initia tive in the context of the Eu ropean security and safety 
framework at European level ....................................................................................... 9 
3.2. The current public health security fra mework at European  and International 
level .......................................................................................................................... .. 11 
3.3. Effects of serious cross-borde r health threats on society ........................................... 13 
4. The Problems and their causes................................................................................... 14 4.1. Gaps in the existing health secur ity framework at European level ............................ 14 
4.2. The problems in addressing serious cross- border health threats at EU level............. 15 
4.2.1. Insufficient and inconsistent prepar edness and response pl anning between EU 
Member States for all types of seri ous 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 – less ons 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........................................................................................................ 2 4 
4.3.1. Preparedness and response planning .......................................................................... 24 
 
EN 4   EN 4.3.2. Risk monitoring and assessment ................................................................................ 24 
4.3.3. Risk management and crisis communication............................................................. 25 5. The Right of the Union to act – Subsidiarity test....................................................... 25 5.1. Justification of public intervention............................................................................. 25 5.2. 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. Policy objectives ........................................................................................................ 29 6.1. General objectives ...................................................................................................... 29  
6.2. Specific objectives...................................................................................................... 2 9 
6.3. Operational objectives................................................................................................ 29 7. Policy options............................................................................................................. 3 0 
7.1. Option 1: Status quo / baseline scenario: Ma intain the current level of activities ..... 31 
7.2. Option 2: Separate and different handli ng of serious cross-border threats to 
health – Enhanced EU cooperation through the use of soft instruments based on a voluntary approach – no le gally binding measures ................................................. 32 
7.3. Option 3: Establish a common EU lega l framework covering all serious cross-
border threats to health by extending ex isting legislation - improved cooperation 
and legally binding measures ..................................................................................... 34 
8. Analysis of the impacts .............................................................................................. 37 8.1. Option 1: Status quo/baseline scenario - ma intain the current le vel of activities ...... 37 
8.2. Option 2: Separate and different handli ng of serious cross-border threats to 
health – enhanced EU cooperation through the use of soft instruments based on 
a voluntary approach .................................................................................................. 38 
8.3. Option 3: Establish a common EU lega l framework covering all serious cross-
border threats to health by extending ex isting legislation - improved cooperation 
and legally binding measures ..................................................................................... 41 
9. Comparing the impacts of the Options....................................................................... 45 10. Conclusions and proposal for implementation........................................................... 47 11. Monitoring and evaluation ......................................................................................... 48 12. ANNEXES AND A PPENDICES .............................................................................. 50 
 
EN 5   EN 1. PURPOSE AND SCOPE1 
The aim of the Health Security Initiative (H SI) 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-bo rder threats that may affect public health. 
These threats can be events caused by communicable diseases, biological agents causing diseases that are not communicable
2, 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 c overed 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 problem s 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 extrem e weather events (heat waves, cold spells) 
and the distribution of food-borne or the burde n of water-borne dis eases, to affect the 
distribution and the frequency of vector-bor ne diseases and cause changes in the 
distribution and frequency of respirat ory 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 Resp iratory 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 number s, i.e. more people will fall ill or even die, 
and/or is unusual for th e given place and/or time.3  
Due to the cross-border nature of these threat s and to their potential severe consequences 
on the EU population, a coordina ted public health approach at  the EU level is necessary. 
The health security initiative aims to esta blish such a common EU framework on health 
security. 
Not all serious cross-border threats to health  are handled in a cons istent 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 wh ich constitutes the 
'lex specialis4' in relation to Article 168 of the Tr eaty of the Functioning of the EU and 
are therefore not covered by this initiative. 
                                                 
1 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.  
2 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.  
3 Chronic diseases, injuries due to transport accide nts, spread of blood borne infectious diseases 
through injecting drug use, th e 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. 
4 EURATOM TREATY, Articles 2b) and 30-39 
 
EN 6   EN Threats emerging from biological (other th an communicable diseases), chemical and 
environmental origin (such as e.g. heat wa ves or cold spells), are not addressed 
sufficiently at the EU level to protect Europ ean 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 establis hed 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 mechan isms for the Member States to cooperate 
effectively in managing outbreaks.  
This discrepancy in the way that serious cro ss 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 ag ents e.g. caused by a criminal or terrorist 
act or as a result of an no n-deliberate act or accident. 
Therefore, the health security initiative inte nds 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 thr ough coherent and more efficient governance 
of health threats.  
In a more general strategic framework, the he alth security initiativ e will help implement 
the European Health Strategy
5 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 cont ext and will build on 
existing instruments and strategies rela ted to disaster prevention and control.7  
The Health Security Initiative will appropr iately take into account the EU external 
cooperation activities for health crises prevention and respons es with third countries and 
explore synergies with the numerous b ilateral EU assistance and cooperation 
programmes with a signif icant health component8.  
The legal basis for th e initiative is pr ovided 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 he alth perspective. Its scope covers the 
following key areas: 
1. the coordination at EU level of the preparedness and response planning for 
serious cross-border threats to healt h, including equitable access to medical 
countermeasures such as vaccines and im proved preparedness for all critical 
sectors in society. 
                                                 
5 Health Strategy: COM(2007) 630 final - White pa per - Together for Health: A Strategic Approach 
for the EU 2008-201; http://ec.europa.eu/health-eu/doc/whitepaper_en.pdf  
6 EU 2020- EU Strategy for smart, sustainable and inclusive growth; 
http://ec.europa.eu/europe2020/index_en.htm 
7 See details in annex 7 
8 See details in annex 7 
9 See annex 1 for article 168 of the Lisbon Treaty 
 
EN 7   EN 2. the monitoring and scientific assessment at EU level of risks from these 
potential threats as inde pendent expertise with s ound scientific advice on 
emerging health threats is required to  respond appropriately to a health 
emergency;  
3. the public health aspects of crisis mana gement and the public health measures 
required under such circumstances to prev ent 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 th e 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 secu rity initiative in various ways, via an open 
online consultation and in face to f ace meetings and audio-conferences. 
The open stakeholder consultatio n on Health Security in th e European Union took place 
between 4 March and 31 May 2011. 75 responses to the on line questionn aire were 
received: 21 on behalf of national, regiona l 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 Mi nistries discuss and coordina te health measures under the 
current regime: the Early Warning and Re sponse System (EWRS) network points 
discussed the health security initiative in th eir meeting in February  2011 and th e 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 Stat es were organised at their 
request and the initiative was also presente d to the EU Health Policy Forum on 19 May 
2011. 
                                                 
10 Measures include medical countermeasures (masks, medicines) and containment of the event and 
decontamination (reduction or re moval 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. 
11 The name of this body might be changed in the legal proposal. 
12 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. 
13 See annex 2 
 
EN 8   EN 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. Th e public consultation results  show broad support for 
strengthening EU public health res ponse in the following three areas: 
First, preparedness planning should address all serious cross-border health threats (i.e. 
communicable diseases as well as chemical, bi ological and environmental threats). The EU 
should play a central role in encouraging nat ional preparedness planning and in coordinating 
national preparedness plans, for example in prov iding 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 consid eration 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 communicati on) should be improved for all serious cross-
border health threats, including also cross-sectora l 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 (H SC) 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 st atus on a legal basis is  also supported. In 
addition, and outside the scope of the stakehold er consultation, the European Parliament and the 
Council have expressed their views to review th e current status of the Health Security 
Committee.14 
Furthermore, the outcome of the open cons ultation process on "strengthening European 
Union Preparedness on Pandemic Influenza" c onducted in 2010 was al so considered with 
regard to the preparedness aspects in this im pact 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 procuremen t of medical countermeasures, especially the 
procurement of pandemic influenza vaccin es 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 Boar d met to discuss the initiative on health 
security. In their overall opini on the board advised that th e impact assessment should be 
strengthened in several respects. 
                                                 
14 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 th e A/H1N1 pandemic'- Health Security, 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/EN/genaff/116489.pdf   
15 See annex 2 of appendix 1 
16 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 . 
 
EN 9   EN First, the report should provide a better descripti on 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 in tended 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 dup lication and administrative costs. A more 
concrete plan for monitoring and eva luation 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 st rategies 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 measu res, 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 proc urement would work in practice. Particular 
attention has been paid to better explaining th e 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 con crete 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, mechanis m, 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 prot ection mechanism, the Internal Security 
Strategy, the Cohesion and Solidarity Funds, pan-European alert networks such as ECURIE, to name only a few
18. 
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 cor porate level is done through ARGUS, the 
Commission's crisis management corporate sy stem. Last but not least, the Commission 
ensures broader internal coordination by m eans 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 th e overall EU crisis and management framework 
referred to above. EU strate gies and policies in the area of law enforcement  and civil 
                                                 
17 See detailed information in annex 7 
18 For further details, please see the "Inventory of Crisis Management Capacities in Commission and 
Agencies" 
 
EN 10   EN protection will be enhanced by th e 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 Info rmation Centre mechanism (MIG) in 
preparedness and response to civil di sasters will also be intensified.  
The Health Security Initiative is a key el ement 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 res ilience 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 envis aged by the EU Internal Security Strategy. 
The Health Security Initiative is also li nked to the overall Eu ropean Programme for 
Critical Infrastructure Protection (EPC IP) framework on the identification and 
designation of European Critical Infrastructure and the assessment of the need to improve their protection
20.  
To support the EU security framework and to  protect citizens from serious cross border 
threats a series of alert, information and ma nagement systems, scientific committees and 
Agencies is already operati ng to ensure food and feed sa fety, plant health, medical 
products safety, consumer protection. Systems ha ve been put in place to control chemical 
accidents, radiological events, border se curity and protection against crime and 
terrorisms.  
In order to avoid overl aps with these existing disaster pr evention 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 hea lth 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 satisfact ory 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 c ooperation by establishing standa rd operating procedures  
Many activities related to pr eparedness 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 th e previous and current health programme22. It 
                                                 
19 See COMMUNICATION FROM THE COMMI SSION TO THE EUROPEAN PARLIAMENT 
AND THECOUNCIL: "The EU Internal Security St rategy in Action: Five steps towards a more 
secure Europe" Brussels, 22.11.2010  - COM(2010) 673 final 
20 COUNCIL DIRECTIVE 2008/114/EC of 8 Decembe r 2008 on the identification and designation 
of European critical infrastructures and the asse ssment of the need to improve their protection; 
http://eurlex.europa.eu/LexUriServ/LexUriS erv.do?uri=OJ:L:2008:345:0075:0082:EN:PDF , see 
chapter 4.2.1.1. for details; 
21 See Gap analysis in appendix 3 on "Structures for preparedness and response to cross-border 
health threats 
22 See annex 9 for details on projects funded under the health programmes 
 
EN 11   EN 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 le gal framework on communicable diseases 
and the main purpose of this Health Security  Initiative is to extend the protection 
provided to European citizens also to seri ous cross border threats to health caused by 
biological, chemical and environmental threats. 24 
In the area of communicable diseases, new di seases 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 h ealth 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 particul ar the deliberate rele ase 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 bette r coordination of public h ealth risk assessment and 
management of other serious cross-border he alth 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 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  
24 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 the 
system and coordination of measures undertaken 
http://ec.europa.eu/health/co mmunicable_diseases/early_warni ng/comm_legislation_en.htm ; Most 
recent examples of the use of the mechanis m 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 Committ ee, 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 in clude management of pandemic H1N1 in 2009 
and a multi state incident of anthrax contaminated heroin 
http://ec.europa.eu/health/prepare dness_response/hsc/index_en.htm  
25 Presidency Conclusions of 15 November 2001 on 
bioterrorism:( http://europa.eu/rapid/pressReleasesActio n.do?reference=PRES/01/415&format=H
TML&aged=0&lg=es&guiLanguage=en ) 
26 Council Conclusions of 22 February 2007 on health security committee: 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf  
27 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 workin g 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 
 
EN 12   EN Other recent cross-border events with poten tial health implications for the EU have 
included volcanic ash clouds or iginating in Iceland, the 'r ed sludge' event in Hungary 
caused by a release of dangerous chemicals in to the Danube and c limate 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 b een reinforced with the entry into force of the Lisbon Treaty30 in 
December 2009. The new provisions state that th e 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 Treat y establishing the European Community (Article 152,4) it 
was only possible to provi de for incentive measures31 or adoption of Council 
Recommendations32 to coordinate Member States' approaches.  
In addition, at international level, the Inte rnational Health Regulations (IHR), a legally-
binding new framework for the coordination of  the management of events that may 
constitute a public health emergency of inte rnational concern, cove r all hazards including 
communicable diseases a nd other health threats. 33 They impose an obligation on each 
Member State to individually build core capacities for surv eillance 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 legi slation. 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 proce dure for marketing authorisation of vaccines. 
Similarly, a possible recommendation regardi ng 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 fo r a legal basis of the Health 
Security Committee, the need for review ed pandemic preparedness planning and a 
proposal for a mechanism for joint procurem ent of vaccines and antiviral medication
34. 
The European Parliament has also recently s upported a proposal for strengthened health 
security at European level35. 
                                                 
28 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/LexU riServ.do?uri=COM:2009:0147:FIN:EN:PDF
; 
http://ec.europa.eu/health/ph_threats/climate/docs/com_2009-147_en.pdf  
29 See overview in annex 6 
30 See annex 1 and also http://europa.eu/lisbon_treaty/full_text/index_en.htm  
31 such as support for projects under the health programmes 
32 For example council recommendations on seas onal influenza vaccina tions, antimicrobial 
resistance and nosocomial infections  
33 See annex 5; IHR entered into force on 15 June 2007 and require gradual implementation by 
2016; http://who.int/ihr/en/  
34 See annex 3 for details on Council requests. 
35 European Parliament resolution of 8 march 2011 on evaluation of the management of H1N1 
influenza in 2009-2010 in the EU (2010/2153(INI)); 
 
EN 13   EN It is against the background of these new deve lopments 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 publ ic health that is concerned but also civil protection, food 
safety, international trade, travel and/or la w 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 th e health services, including intensive care, 
required contact tracing, huge investments in  vaccines and antivirals and had Member States 
competing for better conditions for procurem ent 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 str anded abroad without their usual medicines and 
without any prescription and of course, respirat ory 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 hea lth 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 O1 04 clearly demonstrated ho w 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 assessmen t. 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 vegetabl es in question (salad, cucumbers, sprouts), in 
particular in the South of Europe.  
The estimation of the economic opera tors' 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 seve ral 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 immedi ately 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 14   EN The Commission has also proposed an additional bu dget 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 c onsequences, 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 t oday'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 communi cation has become an essential aspect of 
crisis management as nationa l 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 pr eparedness, the quality of risk assessment and 
the appropriate response ar e decisive in terms of coping with the situation37. Member 
States are in charge of prep aredness 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 he alth consequences are properly managed.  
The different types of serious cross-border threat s 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 wa y as those from communicable diseases.  
For serious cross-border health threat s arising from communicable diseases,38 the 
Member States, the Commission and the scien tific 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 sy stem more notification are alerted than under the 
International Health Regulations40 
                                                 
36 Further examples are provided in annex 6 
37 See Glossary in Appendix 1 for further explanation 
38 See annex 4 for description of existing legal framework for communicable diseases, Decision 
2119/98 and ECDC founding regulation. 
39 See details on the functioning of the system and examples in the information box under 3.1. 
40 See information in annex 11 
 
EN 15   EN However, there is currently no structure, opera tional 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 th reats to health emerging from biological, 
chemical and environmental events, which canno t be addressed due to the lack of an EU 
legal framework.  
Cross border threats to health caused by chem ical, 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 co mmunicable diseases - could amount to 20 -25 
per year. The frequency of such events is likely to increase due to increa ses in global travel and 
trade, climate change and latent risk of criminal and terrorist attacks.  
There is no possibility for a coordinated res ponse with dedicated pub lic health follow up 
measures or agreements on prophylaxis and treatm ent in order to protec t the health of the 
EU citizens affected by those events. At EU leve l 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 interna tional level which cover some 
aspects of preparedness, risk monitoring, risk assessment and risk management for 
serious cross-border threats which may also ha ve public health consequences, e.g. in the 
field of food and feed safety, animal healt h, 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 th ey 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 chem ical, 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 allo w the European Parliament and the Council to 
adopt measures designed to prot ect 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 prepar edness and response planning between 
EU Member States for all types of serious cross-border health threats; 
                                                 
41 This lesser frequency may, at least partially, be due to different monitoring and lack of detection 
tools. 
42 See information in annex 11  
43 e.g. the event of anthrax contaminated heroin e in 2010 necessitated support from Europol and 
EMCDDA 
44 See details in appendix 3: structures for prepared ness and response to cross-border health threats " 
45 Problems and public health consequences are illustrated in annex 12. 
 
EN 16   EN • 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 (o ther than communicable diseases), 
chemical, and environmental threats and weak risk communication procedures; 
4.2.1.  Insufficient and inconsistent prepa redness 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 threat s covered the approaches  on inter-sectoral 
preparedness and the minimum standards ap plied across Member States differ because 
this planning is currently conducted on a vol untary 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 crite ria given that the EU is not a contracting 
party to the IHR. Therefore, Member Stat es 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 func tion properly if electricity fail s or if doctors are unable to 
proceed to work due to the break down of pub lic 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) ha s addressed the need for improved 
coordination of such critical sector s under the "whole society approach"46.  
Health is also an element of the overall European Programme for Critical Infrastructure 
Protection (EPCIP) framework. On 8 Dece mber 2008 the Council adopted Directive 
2008/114/EC47 on the identification and designation of European Cr itical Infrastructure 
and the assessment of the need to improve their protection.  
In the area of communicable diseases, prep aredness planning exists  in particular for 
pandemic influenza48. However, it is not known to what extent sectors other than health 
                                                 
46 WHO, Whole-of-society pandemic readiness - WHO guidelines for pandemic preparedness and 
response in the non health Sector , Geneva, July 2009, 18 available on 
line:http://www.who.int/influenza/preparedness/pandemic/2009-
0808_wos_pandemic_readiness_final.pdf; Detailed information is provided in annex 8. 
47 http://eur-lex.europa.eu/LexUriServ/LexUriSe rv.do?uri=OJ:L:2008:345:0075:0082:EN:PDF 
48 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 th eir plans and preparedness accordingly. WHO is 
 
EN 17   EN have integrated pandemic prep aredness 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 part icular on business continuity  planning, are summarised in 
annex 849.  
As regards generic preparedness, the Commission has published the "Strategy for 
Generic Preparedness Planning, Technical gui dance on generic preparedness planning for 
public health emergencies"50 for all types of health thr eats. 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 standa rds, inconsistent procedur es 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 societ y 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 de lay the EU response capacity 
and negatively impact the situ ation in other Member States. 
These different levels of preparedness in  the Member States may lead to unequal 
treatment and access to medical care for citizen s, endanger activities intended to ensure 
the containment and mitigation of a public h ealth 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 prov ided 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 pr oducts, 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.  
49 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.  
50 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  
51 See annex 8 for further details 
 
EN 18   EN Public health measures taken during a pande mic have the potentia l to cause unintended 
adverse effects on other parts of societ y 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 cl ose for a period of time in an effort to 
reduce transmission, and the cancellation of mass gatherings. 
Therefore increased multi-sectoral preparedne ss, i.e. preparedness not only of the health 
sector but also of other critical sectors in so ciety 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 counte rmeasures – 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 be st practices, thereby considerably weakening the purchasing 
power of the Member States and creating unf avourable contractual conditions. Together 
with restrictions in health budgets, such c onditions may cause some Member States to 
procure an insufficient amount of medical c ountermeasures. This considerably weakens 
the EU's preparedness against serious cros s-border threats to health, as Europe's 
preparedness is only as st rong 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 evaluated
52.  
Lessons learnt at EU level and key messages endo rsed by the Health Security Committee include 
the following53:Member States, the Commission and EU Agencies continue to evaluate pandemic 
preparedness for sectors and service s identified as potentially at ri sk, (health and cross-sectoral), 
particularly as not all sectors experienced si milar 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 continu ity 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 particula r 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 Memb er States were unable to procure 
enough pandemic influenza vaccines and the va ccines when they arri ved did so at very 
                                                 
52 http://ecdc.europa.eu/en/healthtopics/pandemic_preparedness/pandemic_2009_evaluations  
/Pages/pandemic_20 09_evaluations.aspx  provides an overview of  all evaluations on H1N1 
53 Assessment Report on the EU-wide Response to Pandemic (H1N1) 2009 covering the period 24 
April2009 – 31 August 2009: 
http://ec.europa.eu/health/c ommunicable_diseases/docs/ assessment_response_en.pdf ; 
54 Assessment report on EU wide pandem ic vaccine strategies of 25.8.2010 
http://ec.europa.eu/health/c ommunicable_diseases/docs/ assessment_vaccine_en.pdf  
 
EN 19   EN different dates across the EU countries. This contrasted with what happened in parts of 
Latin America and the Caribbean where count ries participating in the Pan American 
Health Organisation routine joint vaccine procurement mechanism received pandemic 
vaccines at approximately the same time, accord ing to a pre-agreed plan and with more 
advantageous conditions than EU  Member States negotiated.  
The procurement of pandemic in fluenza vaccines is challenging for a number of reasons that 
characterise this specific ma rket: 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 va ccines 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 influ enza vaccines during a pandemic. The pandemic 
influenza market is characterised by scarce co mpetition, as only few vaccine manufacturers 
(usually with long-standing expertise in the manuf acture of seasonal influenza vaccines) have the 
capacity and expertise to offer a pandemic in fluenza vaccine with  a valid marketing 
authorisation when a pandemic emerges 
As a result, Member States wishing to secure pande mic 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, par ticularly regarding liabili ty for side effects being transferred from the 
manufacturers to the Member States. In addition, th e lack of flexibility in contracts to include 
conditions under which the reserved amount of do ses could be changed or excess vaccines could 
be returned resulted in an enormous waste of res ources. The Member States that could not accept 
those unfavourable conditions had no guarantee at a ll of being able to obtain pandemic influenza 
vaccines, thus weakening the preparedness acro ss 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 be tween 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 (o ther than communicable diseases), 
chemical, and environmental threats  
4.2.2.1.  State of play 
Risk monitoring and assessment for communi cable diseases is well established at 
European level. Decision 2119/98/EC establ ished the epidemiol ogical surveillance 
system, and the European Centre for Dise ase Prevention and Cont rol (ECDC) provides 
robust, reliable and scientific as sessment for communicable diseases. 
                                                
 
55 http://ec.europa.eu/health/c ommunicable_diseases/docs/ assessment_vaccine_en.pdf   
56 Report of the European Parliament on evaluation of management of H1N1 influenza 2009-2010 
http://www.europarl.europa.eu/sides/getDoc.d o?pubRef=-//EP//NONSG ML+REPORT+A7-2011-
0035+0+DOC+PDF+V0//EN&language=EN  
 
EN 20   EN As regards other serious cross-border threats at EU level, there are a number of agencies, 
networks and structures which address mon itoring and identificati on 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 gr oup indicate that these structures address 
primarily safety or quality as pects (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 re sponsible for public health in the Member 
States or at EU level. 
At international level,  the threat notif ication and risk assessmen t is conducted through the 
International Health Regulations on a b ilateral basis between  WHO and individual 
Member States. Risk assessment is not exha ustive from the public health perspective 
(additional information is missing, such as m eans of treatment for humans, clinical and 
laboratory detection criteria, et c.). 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 thes e gaps and to monitor the public health 
consequences of threats other than communi cable 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 In ternational Health Regulations cover all 
serious cross-border thr eats 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 po licies. There are no cr iteria and no similar 
notification obligations at  EU level, and this leads to a lack of awarenes s 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 he alth risk assessment at EU level leads to 
discrepancies in the evaluati on of the danger level of a given threat, duplication of 
assessments between Member States and inc onsistent interventions at EU level. In 
addition, such a situation can also lead to  inefficient use of the limited resources 
currently available and may dela y appropriate public health measures, which could put at 
risk the overall response at EU level. Ultim ately, 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 For detailed information see annex 7 
58 See appendix 3: structures for preparedness and response to cross-border health threats 
 
EN 21   EN other critical sectors of th e economy and society (e.g. br eakdown 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 unde rmine 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 th e subject from the Health Programme and by 
means of joint efforts with ECHA and JRC. Th e 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 hea lth authorities had to address citizen's concerns 
about longer term effects, particularly for trave llers returning from China who had been at risk 
of having consumed contaminated milk and co mposite 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 chem icals, based on real life events. For example, a 
leaking container on a ferry on the Baltic Sea caused illness in passeng ers 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 http://www.bmj.com/content/326/7381/126.1.full  
 http://www.health.state.ny.us/environmental/ emergency/chemical_terrorism/ricin.htm  
60 http://bioterroreurope.wikispaces.com/file/v iew/Biological+Weapons+and+Bioterrorism+  
Preparedness%3A+Importance+of+Public+Heath+Awareness+and+International+Cooperation ; 
http://www.ndma.gov.pk/Docs/Bio TerrorismGuideINTERPOL.pdf ; http://catalogue.sipri.org/cgi-
bin/koha/opac-detail.pl?biblionumber=75917  
61 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. 
62 http://ec.europa.eu/health/preparedness_response/docs/iridium_1_2011_frep_en.pdf  
 
EN 22   EN It became apparent during the ex ercises that there is a gap in the mechanisms currently in place 
at EU level to trigger and alert or to prov ide 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 an d contain the impact on public health of a 
chemical incident. Standard opera ting procedures for public health impact of a chemical event at 
EU level, and possibly proposal of new provisi ons 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, ch emical, and environmental threats and 
weak risk communication procedures  
4.2.3.1.  State of play  
The Health Security Committee (HSC) is cu rrently the structure at EU level which 
manages serious cross-border health threat s. In terms of preparedness, the HSC's 
mandate provides a platform for the informal  sharing of information and experience on 
preparedness and crisis management strate gies, 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 Memb er States and the Commission share 
information about their messages to the ge neral public. The HSC also facilitates and 
supports coordination and coopera tion efforts generally on h ealth 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 le vel of middle management. The Commission 
provides the secretariat of the Health Secu rity Committee and chairs the meetings. The 
Commission can prepare and table recommenda tions 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 Stat es are not obliged to  take them into 
consideration in their public health response in a crisis situati on. 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. Furt hermore, the HSC has neither the authority nor 
the mandate to effectively coordinate risk ma nagement 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 in ternal concern independently of the nature 
and origin of the threat. The IHR does not ta ke into account the "a cquis communautaire". 
If the threat is serious enough, its action ma y 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 excludi ng other Member States and the Commission 
from the process. 
 
EN 23   EN 4.2.3.2.  The problems, drivers and consequences 
Serious cross-border health threats are una voidable and can have a major consequence 
both on health and on other sect ors of society and the economy  (see annex 6). It is the 
competence of Member States to manage their h ealth services and address health crises at 
national level. However, the mechanisms for ri sk management at EU level are inadequate 
and there is an absence of cl ear mandates, responsibilities and defined scope for decision 
making on the public health response. 
This leads to insufficient coordination of th e public health response and no cross-sectoral 
interlinking for decision making processe s 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 communicat ors has been established unde r the HSC, the lack of a 
formal mechanism for agreeing consistent me ssages to the public and target populations 
does not allow an efficient information proces s at EU level and unde rmines the trust and 
credibility in the pu blic health response to chem ical, biological (other than 
communicable diseases) and environmental threats. 
4.2.3.3.  Examples illustrating the problems 
Lack of coordination of public health measures 
Under the current EU communicable disease legi slation 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, sl ow 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 manage ment across sectors - examples  
There were difficulties in managing cross-border chemical events , as shown in the Iridium 
exercise report. (Sectors concerned were chemical s, transport, health, an d maritime transport). 
                                                 
63 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 
64 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
 
65 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
 
66 HSC/EWRS statement on School closures, 13 August 2009: 
http://ec.europa.eu/health/archive/ph_threats/com/influenza/docs/statement_school_en.pdf  
67 http://ec.europa.eu/health/preparedness_response/docs/council_lessonsh1n1_en.pdf  
 
EN 24   EN 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 Ri ver in 2010 (Environment, chemicals, 
health and civil protection was another example). 
Weak communication strategies 
There were difficulties in communicating with hea lth 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, na tional 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 wh ich serious cross-bor der threats to health are addressed 
across the EU can be expected. The provi sions 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 consider ed 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 pla ce for Member States to implement coherent 
preparedness planning, the situ ation across the EU would re main as varied and multi-
layered as it is now. This means that it w ould be impossible to en sure a coherent and 
efficient public health respons e to serious cross-border he alth threats at EU level. 
There would be no guarantee th at in a serious cross-border  public health event Member 
States would have an equitable supply of me dical countermeasures at affordable prices 
and under equitable contract conditions. This would lead to putting particularly vulnerable groups, such as children and pers ons 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 Inte rnational Health Regulations (IHR) and the way in which 
serious cross-border thr eats to health are addressed in th e EU. This would represent a risk 
to public health management at EU le vel given the differi ng and inconsistent 
implementation by Member States of minimu m core capacities for surveillance of and 
response to public health emerge ncies 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 di fferent sectors, and with Member States, 
would not take place. In this situation, no comprehensive and coherent evaluation of 
                                                
 
68 http://ec.europa.eu/health/c ommunicable_diseases/docs/ assessment_response_en.pdf  (chapter 12) 
 
EN 25   EN public health risks could be assured, and se rious 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 he alth threats would continue to be based on 
informal and ad hoc grounds. The consequenc e 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 inconsiste nt or incoherent at EU level. The system 
would remain voluntary in nature with no le gal obligations for coordination of public 
health risk management. Hence, existi ng 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 heal th authorities, and endanger the efficient 
management of an event. 
5. T
HE RIGHT OF THE UNION TO ACT – SUBSIDIARITY TEST  
5.1. Justification of public intervention 
With the entry into force of the Lisbon Treat y, the EU has been empowered to support, 
coordinate or supplement the action of Memb er States in the ar ea of protection and 
improvement of human health (A rticle 6a TFEU). The Treaty states that EU action shall 
be directed towards improving public health, preventing physi cal and mental illness and 
diseases, and obviating sources of danger to phy sical and mental healt h, and in particular 
"monitoring, early warning of and combati ng 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 si tuation, which does not guarantee such a high 
level in the event of serious cr oss-border threats to health. 
In addition, there is a need to avoid market  failures, in particular to ensure that 
appropriate linkages are establ ished 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 avai lability of essentia l goods, are assured. 
Furthermore, imperfect information flows regarding health crises may endanger the 
decision making process and therefore endang er 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 th e Treaties by supporting, coordinating or 
 
EN 26   EN supplementing the actions of Member States, without superseding th eir competences in 
the area of public health (A rticles 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 resp ecting 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 dimens ion 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 implementi ng its policies and activities (Article 9 
TFEU and Article 35 of the Charter of Funda mental Rights of the European Union). 
5.2.2.  Principle of subsidiarity  
Subsidiarity is respected because the ac tion 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 le vel. The subsidiary 
principle has two aspects: th e 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 im plications (such as the need for coherent 
preparedness planning, or adequate risk a ssessment and risk management procedures) 
which Member States cannot satisfactorily ac hieve individually. In a globalised society 
people and goods are moving across borders an d illnesses and contaminated products can 
circulate within hours across the globe. Public health meas ures therefore need to be 
comparable and coordinated to contain furt her spread and minimise the consequences. 
Less prepared Member States and critical se ctors 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 cons equences across Member  States, therefore, 
necessitates coordinated action at EU level to  ensure that all citiz ens independent from 
their origin or residence can benefit from a hi gh 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 w ith 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 hi gh 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). 
 
EN 27   EN In addition, actions undertaken  by one Member State alone may significantly damage the 
interests of other Member Stat es (e.g. distortion or disrup tion of the internal market, 
limitations on equal access to medical coun termeasures, restrictions on freedom of 
persons, interruption of trade and critical services such as transport, information technologies, health care, energy, banking). C onsultation at EU leve l before adoption of 
public health measures at national level w ould 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 aff ect crucial sectors of 
the economy and society. Many of these sectors are of exclusive or shared EU competence and therefore require the involveme nt of different stakeholders, namely the 
Commission, EU Agencies and national comp etent authorities. Fo r instance, under the 
exclusive competence of the EU a health em ergency may affect the sustainability of 
customs activities at the external frontie r, impact competition policy by excluding 
economic operators and disrupt th e 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 con cerns in public health matters (food safety, 
pharmaceuticals, etc.). 
The EU already has sound experience of c oordination in the field of communicable 
diseases, which are governed by comprehens ive EU legislation and which has proved 
essential in handling seri ous 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 coordinati on at all levels for a ddressing serious cross-
border health threats, thus provi ding added value across the EU. 
The preparedness of the Member States will be st rengthened 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 counterm easures 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 In the aftermath of the 9/11 terrorist attack in the USA, the Anthra x scare undermined the 
availability of the antibiotic ciprofloxacin. Du ring the SARS event, to urist and transportation 
industries have been heavily impacted by the restriction of movements on a global level. 
71 See examples: E. coli  STEC O104, Volcano ash, red sludge, SARS 
72 See further details on EWRS in annex 4 
 
EN 28   EN Since not all Member States have the same leve l 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 c ountries 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 impl ementation of the IHR, where relations are 
established only between individual states and the World Health Organization. 
5.2.3.  Principle of proportionalit y 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 natio nal decision making, while 
achieving satisfactorily the objectives set out for this initiative. EU action is without 
prejudice to the decision-making process in pl ace at national level and is related to the 
monitoring, early warning and combating of se rious cross-border threats to health. The 
aim of EU action is to be tter coordinate such meas ures. It fully respects the 
responsibilities of the Member  States to define their health policy and for the 
organisation and delivery of hea lth services and medical care. 
As such, the stakeholder consultation reflected  strong support for EU intervention at this 
level. In addition, an assessment has recently be en carried out to ensure that the measures 
proposed in this initiative wi ll serve to complement exis ting 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, cohere nt and comprehensive long term solution for 
improving health security related to all cro ss border health threat s 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 set ting up a joint procurement of 
medical countermeasures. 
                                                
 
73 http://ecdc.europa.eu/en/publications/Publications/0701_TER_Pandemic_Influenza_  
Preparedness.pdf  
74 See appendix 3: structures for preparedness an d response to cross-border health threats  
 
EN 29   EN 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 initiativ e is to reinforce the response to all serious cross-
border threats to health
75 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 in teroperability among sect ors at EU level and 
among Member States. This includes improving equitable access to medical countermeasures (e.g. pandemic influenza vaccines). 
In the area of risk monitoring and assessment
 the specific objective is to create the 
necessary conditions to ensure a cohere nt 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 cr eate the necessary conditions 
to strengthen and enhance coordination am ong Member States, international bodies and 
the Commission in order to ensure a cohe rent and consistent policy approach to 
effectively manage responses to serious cr oss-border health th reats across the EU. 
As regards risk and crisis communication,  the aims of the initiativ e 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: 
– to develop and update comparable a nd coherent generi c 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 
                                                 
75 other than those associated with radio nuclear events 
76 Objectives should be specific, measurable, achievable, realistic and timed (SMART); the 
operational objectives listed are specific and meas urable in numbers of preparedness plans, 
agreements etc. They are also r ealistic 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 environmen tal events. Related to the timeframe for 
implementation the objectives should be achieved three years after adoption of the proposal.  
 
EN 30   EN prepared to cope with such health risk s 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 a nd tailor-made EU cr iteria for notifying 
threats in order to ensure stronger, con tinued and resilient operation of the health 
sector for the European Union, base d 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 m echanisms and structures; 
– to strengthen and create capacities for robust, reliable, and rapidly available 
public health risk assessment; 
– to provide mechanisms for reinforced c oordination 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 manage ment and crisis communication  the operational objectives 
are: 
– to strengthen the capacities and proce sses for and establish a sustainable 
structure for coordinating the public hea lth response at EU level for any cross-
border public health crisis; 
– to clearly define the scope of the activ ities 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 comm unication on health threats, and provide 
for rapid exchange and agreement on communication messages and strategies; 
7. P
OLICY OPTIONS78 
In order to cover all aspects of crisis management in a coherent framework,  each of the 
options presented includes solutions for pr eparedness and res ponse 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 re quirements and the level of obligation for 
implementation by the Member States, the informal or formal nature of the expertise 
                                                 
77 See information as regards the International Health Regulations (IHR) in annex 5. 
78 An overview of the actions proposed under the three options can be found in annex 13. 
 
EN 31   EN provided for risk assessment, and the power conferred on the EU w ith regard to risk 
management: 
• Option 1 (the status quo) envisage s 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 cooperati on between existing structures and 
systems. There are no legally bi nding measures under this option. 
• Option 3 proposes a legal framework that  lays down binding measures for 
Member States as regards prepared ness planning, provides a legal basis 
for voluntary measures and implemen ts a robust structure for crisis 
management. This option seeks to  amend the existing Council and 
European Parliament Decision on comm unicable diseases and extend it to 
serious cross border hea lth threats caused by biological (other than 
communicable diseases), chemical or environmental events. The provisions for risk assessment under th is option are not included in the 
legal framework as they also build on closer cooperation between existing 
structures and systems and are intende d to cover existing gaps in these 
areas. 
7.1. Option 1: Status quo / baseline scen ario: Maintain the current level of 
activities  
Preparedness and response planning 
On preparedness the Commission would conti nue the technical level work with the 
Member States described where appropr iate 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 wher e public health  crises are 
simulated, and exchange of be st practice would continue.
79 
To improve equitable access to medical countermeasures, the Commission would 
continue to support Member States' cooperati on, e.g. in helping Member States prepare 
their national tende r specifications  for vaccine procurement. 
The Commission would also continue to  promote improved production capacity, for 
instance through improved vaccination covera ge for seasonal influenza, which could 
influence capacity building for the pr oduction of pandemic influenza vaccine. 
Risk monitoring and assessment 
The EU would continue to work with th e existing voluntary based notification and 
monitoring mechanisms and structures w ithout strengthening coordination among the 
policy areas concerned. Communicable diseas es 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 fr om the EU Health Programme 
 
EN 32   EN already by a legal framework), chemical, ) a nd environmental events  would be delivered 
on the basis of ad hoc support networks as th e ECDC has no mandate for risk assessment 
for threats other than communicable diseases. 
Risk management and crises communication 
The mandate of the Health Security Co mmittee under the Council conclusions of 22 
February 200780, as prolonged by the Council conc lusions of 13 September 2010, would 
be maintained and the Counc il would be the EU institu tion which would prolong its 
mandate, as in the current s ituation. 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 woul d continue to facilit ate 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 handlin g 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 pl anning based on common criteria between the 
Member States and in relation to IHR; b. improved, more sustainable and structured 
cooperation between existing systems for h ealth emergencies caused by biological, 
chemical, or environmental events; c. clarification of the role s of existing management 
bodies, in particular the EWRS network
81 and the HSC82. Action under this option would 
mainly be built on soft instruments such as guidance, Commissi on 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 nece ssary changes; however, the actions under 
this option would still require  cooperation of Member Stat es 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 shar ed approach on generic and 
specific preparedness planning, including for pa ndemic 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 activi ties building on and 
strengthening requirements under IHR. 
The Commission would provide guidance on im proved cross-sectoral  preparedness and 
interoperability and continue to encourage exchange of best prac tice through seminars 
and workshops and provide incentive measures via the Health programme. 
                                                 
80 http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf  
81 See details in annex 4 
82 See details in annex 2 
 
EN 33   EN In order to improve equitable access to medical countermeasures the Commission could 
continue, as described in option 1, to ta ke incentive measures relating to capacity 
building for vaccine production and to play  a supporting role in  Member States 
cooperation, e.g. in the prepar ation of their national tende r specifications. However, it 
should be noted that this option would not improve the conditions for procurement of medical countermeasures, other than th e Commission supporting Member States in 
preparing their national tenders. 
In addition, as part of op tion 2, the following incentiv es could be envisaged: 
1. stimulate via the Innova tive Medicines Initiative
83 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. Ex amples of how such a 
complementary EU stockpile could l ook like and what it would cost are 
given in annex 17. 
3. strengthen national procurement pr ocedures by improving the exchange 
of information on contractual cond itions 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 w ould be issued to mu tually notify each 
other and the Commission of threats by means of  tailor-made criteria as required by the 
integrated nature of the EU. However, ther e would be no obligations for Member States 
to do so. 
Risk monitoring and risk assessment for othe r serious cross-border threats to health 
would rely on improved coordination by puttin g in place informal arrangements among 
existing EU structures, such as the EU agenci es 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 woul d be carried out using existing financial 
and administrative resources. 
Risk management and crisis communication 
                                                 
83 http://www.imi.europa.eu/  
84 For medical countermeasures that are available be fore a threat arises, e.g. ciprofloxacin against 
anthrax. 
85 For medical countermeasures that  are not available before a thr eat arises, e.g. vaccines against 
pandemic influenza. A virtual stockpile is a gua ranteed number of dose s of the pharmaceutical 
which will be delivered when it becomes available. 
86 The required simplification and updating the framework for communicable diseases regarding 
epidemiological surveillance in orde r to take account of the establis hment of the ECDC is not part 
of the impact assessment as changes can  be considered as purely technical 
 
EN 34   EN The Health Security Committee87 would be abolished in its current form and formalised 
as a Commission-led expert group. Its ma ndate would be reviewed and limited to 
coordination of preparedness, notification of measures impl emented at national level and 
coordination of response for serious cross-bord er 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 communicatio n approaches and guide lines, 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 exte nding existing legislation - improved 
cooperation and legally binding measures  
EU competences on communicable diseas es as laid down in Decision 2119/98/EC89 
would be extended to cover all other se rious cross-border threats to health90. Legal 
provisions would take account of  specific aspects of these ot her threats and the measures 
related to preparedness, notif ication and risk management would be legally binding on 
Member States. A legal base for joint procurement of medi cal 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 build ing on improved and sustainable cooperation. 
Additional financial implicati ons 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 ha ve the obligation to put in place an agreed 
approach on generic and specific prepar edness planning, including for pandemic 
influenza and would report re gularly on its implementation. As  regards preparedness for 
multidisciplinary implications of a crisis, Me mber States would consent to cooperate in 
the cross-sectoral prepare dness and response planning through the establishment of 
guidelines and indicators, the or ganisation of exchange of be st practices and preparation 
of periodic monitoring and evaluation. Bu ilding on ongoing work to  ensure business 
continuity in critical sectors in Europe, inte r-sectoral coordination would be enhanced to 
ensure that other critical s ectors (e.g. transport, energy, ICT) apart from public health 
                                                 
87 http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf  
88 The issue of preparedness and coordination measures regarding pandemic influenza would fall 
under the structures established by Decision n° 2119/98/EC. 
89 Currently limited to communicable diseases 
90 Apart from threats caused by radiological events 
91 A detailed description of the tasks and obligations of the Member States and the Commission 
under this option is provided in annex 15.  
 
EN 35   EN have detailed and comprehensive preparedne ss plans in place. The focus would be for 
Member States to ensure business continuity in these sectors to improve the sustainable 
functioning of these sect ors in the event of a crisis. Memb er States would also agree to 
implement in a complementary way require ments on shared common minimum core 
capacity standards for preparedness and re sponse (e.g. adequate  human resources, 
designation of responsible  entity). Furthermore, Member St ates would agree to use tailor-
made criteria for notification at EU level of serious cross-borde r threats to health, 
including events which may c onstitute public health  emergencies of international concern 
under IHR. 
This option provides a legal basis for a jo int action for the purchasing of medical 
countermeasures, such as pandemic influenza vaccines. This would create an opportunity 
to set up and manage an EU mechan ism for joint procurement of medical 
countermeasures in whic h Contracting Parties92 could participate, on a voluntary basis. 
The procedural and organisa tional arrangements of the joint procurement mechanism 
would not be part of the le gal act but would be laid do wn in a 'Joint Procurement 
Agreement' signed by all participating C ontracting Parties. The joint procurement 
mechanism will give full flexibility to the C ontracting Parties to procure what and how 
much they want. The purchasing power of th e participating Contracting Parties will be 
strengthened by pooling similar procurement requirements. Whereas the Commission will coordinate the joint procurement mech anism, the Contracting Parties will be 
responsible for awarding and signing framework contracts
93 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 e nvironmental events will be formalised and 
strengthened. 
A coordination system will be put in place an d 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 th ey have already done in the past – notify 
threats arising from communicable diseases. 
In parallel, Member States w ould be obliged to notify the EU level in all cases where 
notifications are made to WHO under th e International H ealth 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 exampl e to trace persons exposed to a chemical 
contaminant. 
Where the ECDC or another EU Agency, Me mber States or the Commission identifies 
serious cross-border threats to health, on the ba sis of either notification systems or risk 
                                                
 
92 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). 
93 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 36   EN monitoring, a risk assessment may be performed using exis ting structures at EU or 
national levels in conjunction with the Co mmission. The Commission would be tasked to 
provide for a coherent and comprehensive pub lic health risk assessment at EU level. 
Potential gaps in risk assessments for sp ecific threats would be  covered by putting in 
place additional capacities for scientific ex pertise. 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 expe rtise can be requested when needed. This 
contract would help to establish permanen t networks of nationa l correspondent s 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 spec ific health threats w ould 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 invest ments contribute to 
capacity building in terms of im proved 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 cros s-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 bi ological threats, chemical and environmental threats and 
threats of unknown origin). 
On this basis, the relevant criteria for bi nding notification of such threats would be 
specified and the conditions and rules woul d be laid down in such a way that a 
coordinated and coherent public health re sponse can be undertaken. This option would 
specify, as is currently the case for communicab le diseases, the other types of threats to 
be covered, criteria for no tification of events and areas where measures could be 
coordinated at the EU level. It would provi de for EU action through advisory activities, 
non legislative acts and instruments for mutu al agreements or joint actions between 
Member States. 
EU action as described above w ill – as is the case for comm unicable diseases - cover the 
following measures as a priority: 
(a) Advisory activities on preparedness and response planning, public health 
response coordination such as on school closure, travel advice, communication 
strategies and coordinated messages, a nd common strategies on vaccination. On 
this basis the Commission may, with the support of expert groups, adopt 
recommendations to Member States  and clarify the scope of these 
recommendations in a legal text.  
(b) Non legislative acts (i.e. delegated a nd implementing acts) would cover for 
example guidelines on protective measures  to be taken, particularly in an 
                                                
 
94 Costs estimated based on the costs incurred for a framework contract in the past for setting up a 
pilot project on assessment of health th reats other than communicable diseases. 
 
EN 37   EN 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 volunt ary instrument mechanism for joint procurement of medical 
countermeasures, particularly pandemic vaccines, would be established. 
Communication would be greatly impr oved by the development of common 
communication strategies and by better integr ating the Communicators into the crisis 
management process and by closer linki ng decision makers and risk managers. 
Coordination of a crisis would be organi sed with the help of a Health Security 
Committee composed of representatives of Member States and chaired by the 
Commission which provides also the secretar iat to this committee. Thus, the current 
work consisting of coordination of public health response done by the EWRS Network 
and the Health Security Committee, includ ing work on communication, would be merged 
in order to cover all se rious cross-border threats to hea lth within a single structure.  
8. ANALYSIS OF THE IMPACTS  
As described under chapter 3, health emergenc ies can have huge impacts on the health of 
citizens and society, and can also have signif icant financial conseque nces, 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 propos ed under each option are thoroughly analysed 
as regards their effects and conseque nces in relation to the objectives. 
In addition, annex 19 describes further imp acts: in particular social and economic 
impacts, financial implications and admini strative burden, EU added value and the 
impact of each option at international level. 
None of the identified options will have im pacts on the environment or employment that 
can be predicted with any accuracy. 
8.1. Option 1: Status quo/baseline scenar io - 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, th is 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  
 
EN 38   EN 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 shor tfalls identified in these areas.  
Economic impact : In a status quo situat ion, critical sectors wi ll 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 repercu ssions such as productivity losses and absenteeism97). As a 
consequence, internal market and external tr ade functions could be disrupted, leading to 
substantial economic losses as illustra ted 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 st akeholders, resources to support 
work on combating serious cross-border health  threats will mainly be allocated by the 
administrative budget of the EU (for exampl e 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 H ealth 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 handlin g of serious cross-border threats to 
health – enhanced EU cooperation th rough the use of soft instruments 
based on a voluntary approach 
Public health impact : The impact on public health co uld 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 cohere nce of public health se curity structures and 
systems. This would be achieved thr ough EU-wide recommendations supported by 
Member States. However, these positive imp acts 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 prepare dness, improved coordination of existing 
notification tools and strengthe ned risk assessment capacities,  thus stepping up the level 
of capacity to react more rapidly and comprehe nsively to a cross-bord er health threat. In 
addition, the risk management structures suppo rting a coordinated response at EU level 
would be sustainable if they had clearer mandates, thereby improving the effectiveness of 
heath crisis management. Crisis communicatio n would be enhanced and benefit from a 
more coherent approach and capacities when managing a crisis. However the quality and 
                                                
 
96 See annex 8 for further details 
97 http://www.who.int/countries/ eth/areas/cds/en/index.html  
98 http://europa.eu/rapid/pressReleasesAc tion.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  
 
EN 39   EN coordination of the response to a threat would only be as strong as the weakest link of the 
whole structure and depend on the prepare dness of Member States to implement. 
The impact of this option on access to medica l 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 pr oduction techniques to 
improve production capacity for medical counterm easures such as has been achieved in 
the United States by the Biomedical Advanc ed Research and Development Authority 
(BARDA) initiative99. An improved production capacity means that a larger proportion 
of the population can be protect ed or treated within a short time frame when a threat 
emerges. 
In addition, this option foresees the setti ng up of a complementary EU stockpile which 
could alleviate urgent/unforeseen needs ex ceeding the capacity of national stockpiles. 
Social impact : Provided that the Member States implement the agreed guidance and 
recommendations, improved risk management a nd, in particular, better coordination of 
risk communication is likely to have a benefi cial 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 expert ise to be pooled among the Me mber States solidarity and 
cooperation to be improved in  terms of preparation of th e procurement procedures, as 
smaller Member States would benefit from the skills and lessons learnt from other 
countries. A complementary EU  stockpile of medical count ermeasures that can be 
deployed to help Member States with urgen t/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 conse quences related to a health event. For 
example, the disruption of the internal mark et and external trad e functions might be 
minimised and economic losses reduced. Howeve r, these potential impacts would rely 
essentially on the Member States' commitmen t 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 innova tion and R&D efforts related to new 
production techniques to improve the i ndustry's production capacity for medical 
countermeasures, as further support actions could be envisaged in particular under 
existing instruments (e.g. Innova tive Medicines Initiative100). 
Financial implications : The main stakeholders under this  option are the Member States 
and the Commission. No additional costs e ither for Member States or for the 
Commission are expected  under this option.  
Regarding research and development of me dical countermeasures , existing financial 
mechanisms will be used as much as possible (Innovative Medicines Initiative).  
                                                 
99 http://www.phe.gov/prepared ness/pages/default.aspx  
100 http://www.imi.europa.eu/  
 
EN 40   EN As regards access to medical countermeasur es, option 2 remains at the level of 
cooperation between individual pr ocurements 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 jo int 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 need ed to procure medical countermeasures for 
their national stockpiles individually, the w eak 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 influe nza pandemic. However, this initiative was 
withdrawn as the Health Council did not r each 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 mi nimise costs. However, this does not seem 
feasible in the EU since Artic le 168 of the Treaty does not provi de 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 th e newly created expert committee based 
on the former Health Security Committee) wo uld be clearly defined, thereby minimising 
the risks of overlap. However, these gains w ould be limited as ther e would still be two 
separate entities.  
As regards access to medical countermeasures, the administrative burden could also be 
reduced for Member States as cooperati on between individual national procurement 
procedures would allow the pooling of natio nal 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 le vel would be created addition al administrative capacities 
would be needed in particular during th e setting up phase and devising and testing 
mechanisms for delivery and distribution in a crisis.  
EU added value : The EU added value would be in creased as the coordination of 
preparedness and response to cross-border hea lth 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 ma de to link International Health Regulations 
more effectively to reporting of threats at EU level. 
                                                 
101 http://europa.eu/rapid/pressReleasesActio n.do?reference=IP/06/732&format=PDF&  
aged=1&language=EN&guiLanguage=fr  
102 http://www.bwl.admin.ch/themen/01009/01025/index.html?lang=en  
103 In the case of Austria, savings involved in a joint procurement amounted to 60% of administrative 
costs: http://ec.europa.eu/environm ent/gpp/pdf/toolkit/module1_fact sheet_joint_procurement.pdf   
 
EN 41   EN 8.3. Option 3: Establish a common EU legal framework covering all serious 
cross-border threats to health by exte nding 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 effectiven ess of public health security structures and 
systems at EU level would be considerably  improved. It would i ndeed allow coherent 
preparedness planning based on shared a nd common mandatory st andards and a better 
coordinated and balanced respons e to all types of cross-border  health threats. This would 
be supported by establishing a single structure addressing the manageme nt 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 struct ures, as well as EU tailor-made criteria for 
notification of health threats. Along with e nhanced and sustainable cooperation for risk 
assessment with existing networ ks of national expe rts, relevant Commission services, EU 
agencies and international orga nisations, this option would re sult in a more coherent and 
comprehensive approach to id entification, notification and assessment of serious cross-
border health threats. 
Finally, by setting up a legal ba sis allowing voluntary joint procurement, this option 
would considerably improve equitable access by Member States to medical countermeasures, thereby ensuring a higher leve l of protection of th e EU citizens across 
the Union. The positive public health impacts related to the development of such a 
mechanism were further demonstrated by previ ous similar initiatives developed in other 
countries and regions
104. 
Furthermore, inter-sectoral c ooperation would be improved in the event of cross-border 
health threats, also contribu ting to better public health prot ection. Critical sectors would 
be identified and prepared, and procedures  for improved inter-sectoral coordination 
would be established based on the 'whole of soci ety' 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, increase d cooperation would f acilitate a better 
understanding of citizens' needs and worries, be tter targeted message s, 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 e ffective vaccination campaigns. In addition, 
such a mechanism would promote solidarity be tween the Member States by ensuring that 
participating countries have a minimum le vel of access to medical countermeasures.  
                                                 
104 One Year assessment of joint pr ocurement of pharmaceuticals in the public health sector in 
Jordan, http://www.sciencedirect.com/s cience/article/pii/S0149291809001672  
 
EN 42   EN Economic impact : Under option 3 the positive impact s 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 resear ch the setting up of a joint 
procurement mechanism on medical counterm easures would strengthen the supply of 
medical products and encourage existing and potential new suppliers to develop new products based on long term contracts ag reed 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 he alth sector and in  other sectors.  
A. Costs for preparedness, assessment and manage ment of the Health Security Initiative 
For the Member States  notification costs are not expected to increase significantly as 
Member States are already obliged to repor t either at the EU level on communicable 
diseases or to the WHO under the Internatio nal 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 Stat es 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 borde r threats to health. 
As regards the newly established reporting a nd monitoring procedures to implement the 
improved health security framework the following costs per Me mber State can be 
envisaged: 0.3 – 0.5 Full Time Equivalent fo r a national expert over a period of 2-3 
months to address reporting. 
For the Commission:  as regards preparedness additiona l costs could be expected, in 
particular in relation to human resources and the provision of technical equipment; 
however, it is planned to cove r these staff capacities/overhe ad 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 asse ssment 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 or der 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 othe r than communicable diseases in the past. 
The intended framework contract is planned to allow for such gaps to be filled by establishing permanent networ ks of national correspondents between health authorities 
and agencies competent in assessing specific h ealth 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  
 
EN 43   EN Cross border threats caused by chemical, biol ogical and environmental events do not 
occur as often as communicable diseases. Ba sed 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 measur es 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 jus tified 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 coordinati on 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 requireme nts 0.3 Full Time Equivalent for an 
Administrator/Policy Officer for the repor ting process will be needed. EUR 5,000-20,000 
for external expertise to support the developm ent 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 fo r 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 alre ady 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 po wer, economies of scale, more attractive 
offers from suppliers and improved cont ract conditions for the Member States
107 (for 
further details see annex 17) . In addition, a joint procuremen t 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 administra tive 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 See information in annex 11  
107 http://www.rho. org/files/IAVI_vaccine_pr ocurement_pricing.pdf ; Local Authority Procurement: a 
research report, UK Office of  the Deputy Prime Minister, 
http://www.communities.gov.uk/arc hived/publications/localgovernm ent/localauthorityprocurement ; One 
Year assessment of joint procurem ent of pharmaceuticals in the pub lic health sector in Jordan,: 
http://www.sciencedirect.com/science/article/pii/S0149291809001672  
108 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 
 
EN 44   EN It is not expected that private companies w ould 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 particul ar large companies have already engaged in 
putting in place business continuity planning at  their own initiative based on the rationale 
that investing in business con tinuity is highly cost effectiv e albeit by nature never cost 
neutral or possible without any administra tive input. There is no intention to impose 
measures with financial implications. The inte ntion is to encourage the exchange of best 
practice illustrating the overall  benefit of improved busines s continuity planning thereby 
encouraging companies to invest in business continuity planning.  
Administrative burden : As regards preparedness and re sponse planning there would be a 
certain administrative burden for Member States  to develop and implement core capacity 
standards in line with the International Hea lth 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 al ready obliged under EU 
legislation to notify health threats includi ng 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 es tablish links between these 
systems and review existing reporting mechan isms; however, this burden will decrease 
once the connections and links ar e made. Thus established efficiency will be gained and 
coherence and cooperation between reporting  tools will have positive effects on 
administrative procedures, they will be stre amlined and double work will be avoided.  
Costs induced for reporting are supposed to add administrative burd en, however will be 
counterbalanced by improved reporting and in formation and hence better preparedness 
for future crises. 
Under this option governance in public health risk manage ment would be significantly 
improved as only one expert committee would need to be operated.  
As regards the newly established reporting a nd monitoring procedures to implement the 
improved health security fr amework 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 dutie s under the Internationa l Health Regulations 
synergies in the reporting can be expected. In addition, Member States would need to 
dedicate staff capacities ever y five years to contribute to an external evaluation. 
With a more systematic and structured appr oach synergies in the work invested by 
Commission staff can be expected and no additional administrative burden. 
Additional efforts would need to be undert aken by improving coordi nation 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 se tting up phase of the 
proposed mechanism for joint procurement of  medical countermeasures in form of 
additional staff and administ rative burden for the entity in charge of operating the 
contract (see details under financial impli cations) but for those Member States that 
envisage adequate provisi on and preventive measures for a future pandemic the 
 
EN 45   EN administrative procedures have to be implem ented any way. This task might be assigned 
to the Commission, there are however options th at external support is requested for this 
task, e.g. by assigning this task to an Agen cy or Body in charge of procurement or 
contract management. 
These administrative effects would decrease du ring the running of the contract prior to a 
cross-border health th reat. In the case of an outbreak or a public  health event which 
would require the activa tion of the contract, the administ rative needs would rise steeply: 
However, for the participating countries the proposed mechanism will result in a 
significant reduction of administ rative burden as it would enab le the pooling of different 
skills and expertise betw een national authorities109. 
EU added value : Under option 3, the EU added value would be increased across all 
aspects of preparedness and response planning, risk assessme nt 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 heal th threats across the 
EU. 
Impact at international level : Better coordination  in the EU of the International Health 
Regulations implementation by the Member Stat es and closer collaboration between the 
EU and WHO on preparedness for and resp onse to public health emergencies of 
international concern would contribute to enhance global health security. It would 
contribute to better control the spread of diseases internatio nally 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 heal th risk assessment and management could 
be undertaken more effectively at internati onal 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 fo r comparing the impact of the three options 
are: improved impacts in the public health ar ea, social and economic  impacts, financial 
implications, administrative burden, EU adde d value and impact at international level. 
The options are rated according to their imp act against these key cr iteria. 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 scenari o, these conclusions 
focus on options 2 and 3, where new impacts can be expected. 
                                                 
109 EC Green Public Procurement Training Toolkit – Joint Procurement Fact Sheet, 
http://ec.europa.eu/environment/gpp/pdf/toolkit/module1_factsheet_joint_procurement.pdf   
110 Annex 20 provides an overview of the ratings for the different options based on the detailed 
analysis set out in annex 19. 
 
EN 46   EN 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 w ould not be guaranteed as th ey would rely only on the 
commitment of the Member States. In comparison, option 3 which sets out a new coherent framework on prepare dness planning at the EU leve l, also establishes common 
mandatory standards that would lead to cons iderably 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 provi de for a more cohere nt 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 cr oss-border health threats at the EU level. 
In addition, the risk assessment capacities w ould be improved by fill ing gaps in current 
risk assessment capacities under option 3. 
In the area of risk and crisis management , option 2 would improve th e overall situation as 
the two committees' mandates would be clar ified. 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 co mmunicators and crisis mana gers 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 le ss 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 to implement common guidelines for communication. However, option 3 would pr ovide 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 c ountermeasures to citizens across the EU. 
Concerning the economic impacts
, option 3 is favoured over option 2, as, due to 
increased cross-sectoral collaboration and le gally binding measures , under option 3 other 
sectors of the society would be better prepar ed for the negative repe rcussions of a public 
health event. 
 
EN 47   EN 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 impr oved protection of 
citizens against serious cross-bor der health threats. The key reason for this is that it 
proposes a comprehensive framework for h ealth security stru ctures 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 al l types of public health ev ents by merging two existing 
committees into one. 
Option 3 also offers the best possible EU a dded 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 additi onal 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 h ealth security is done in a 
coherent and coordinated manner at EU level. The Member St ates are already obliged to 
implement the International Health Regulations (IHR). In this initiative the implementation would be done in a coordinate d 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. 
• Provide relevant information on seri ous cross-border th reats to health 
collected through monitoring systems by using agreed case definitions. 
• Notify measures and events of seri ous cross-border th reats 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 coordinatio n would involve agreeing to binding 
procedures concerning informat ion exchange, consultations and 
coordination.  
 
EN 48   EN • Voluntarily participate in joint acti ons in particular related to joint 
procurement for pandemic influenza v accines 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 even ts as they are currently for communicable 
diseases. Under the improved conditions for preparedness in particular for joint procurement mechanisms on medical counter measure 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 Europe an level but also in a global context as 
provisions at European level will be aligned to Intern ational Health Regulations. 
Overall this option would not  only strengthen the prepar edness provisions for serious 
cross border threats to health caused by chemi cal, biological and environmental events, it 
would also make existing guidelines for co mmunicable diseases more enforceable.  
The legal form under this option would be a legislative act of the European Union 
adopted by ordinary legislativ e 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 article s on the subject matter, scope, definitions, 
preparedness and response planning, joint pr ocurement of medical countermeasures, 
epidemiological surveillance and monitoring, earl y warning and response system, public health 
risk assessment, coordination of response, health security committee, exercise of the delegation, 
urgency procedure, designation of national au thorities and representatives, collaboration with 
third countries and international organisations, protection of personal data, and reports. An 
annex would provide a list of communicable di seases and special health issues subject to 
epidemiological surveillance. 
The proposal would simplify the existing legisl ation. It would improve transparency due 
to less implementing measures  (all decisions implemen ting 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 es tablished to manage all types of health 
crises. 
11. MONITORING AND EVALUATION  
For the systematic follow-up of the policy m easures in the field of preparedness and 
response planning, risk assessment and risk management, monitoring and evaluation of 
the implementation of the legislative inst rument 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 th e structures and mech anisms provided for by 
the Health Security Initiative will be base d on information from Member States supplied 
annually, with scientific support from specialis ed agencies and organi sations such as the 
ECDC or EMA to provide a basis for co mparison and consistency in Commission 
reporting.  
 
EN 49   EN The main instrument for gathering data for th e purpose of such an evaluation will be a 
reporting system that will be approved a nd 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 Globa l Health Security Initiative (GHSI)111 may be 
considered where appropriate. 
Reporting will cover information on cooperati on mechanisms established, key sectors 
involved and websites in place to share inform ation 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 capa cities, measures and plans in terms of 
preparedness, risk assessment and risk mana gement at the level of each Member State 
and for all threats other than communicable di seases is currently be ing drawn up. It will 
allow indicators to be further defined and serve as the benchmark against which progress 
will to be measured after appr oval 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
 
 
EN 50   EN 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 secu rity framework and pandemic 
preparedness planning 
4: Existing legal framework for communicabl e diseases, Decision 2119/98 and European 
Centre for Disease Prevention and Cont rol (ECDC) and implementation of the 
framework 
5: The International Heal th Regulations (IHR)  
6. Examples of effects 7: EU mechanisms and strategies for disast er 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 th e 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 th e options and their implications for the 
health sector 
17: Examples of potential co mplementary EU stockpiles 
18: Illustration of the joint procuremen t mechanism for medical countermeasures 
19: Analysis of the impacts of the three options 20: Comparison of the policy options 21: Monitoring the implementa tion of suggested actions 
22: Glossary 
 
EN 51   EN 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 
 
EN 52   EN 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 po licies, shall be directed towards improving 
public health, preventing physical and mental illness and diseases, an d 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 ed ucation, and monitoring, early warning of and 
combating serious cross-border threats to health. 
The Union shall complement the Member Stat es' action in reducing drugs-related health 
damage, including information and prevention. 
2. The Union shall encour age cooperation between the Member States in the ar eas 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 comple mentarity 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 prom ote such coordination, 
in particular initiatives aiming at the esta blishment of guidelines and indicators, the 
organisation of exchange of best practice, and the preparation of the necessary elements for 
periodic monitoring and evaluati on. The European Parliament shall be kept fully informed. 
3. The Union and the Member States shall fost er 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 C ouncil, acting in accordance with the ordinary 
legislative procedure and af ter 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 orde r to meet common safety concerns: 
(a) measures setting high standards of quality a nd safety of organs and substances of human 
origin, blood and blood derivatives; these measur es 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 th eir 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 af ter consulting the Economic and Social Committee and the 
Committee of the Regions, may also adopt in centive measures designed to protect and 
 
EN 53   EN improve human health and in particular to co mbat 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 protecti on 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 Commis sion, may also adopt recommendations for the 
purposes set out in this Article. 
7. Union action shall resp ect the responsibilities of the Member States for the definition of 
their health policy and for the organisation and delivery of health serv ices 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 a ssigned 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. 
 
EN 54   EN Annex 2: The Health Security Committee 
1. History 
In the aftermath of the terrorist attacks in 200 1, and in particular the deliberate release of 
Anthrax toxins in the US, the EU health minist ers decided to set up th e EU Health Security 
Committee (HSC)112 as an informal structure for better  coordination of pub lic health risk 
assessment and management on other serious cro ss-border health threats in the EU. At the 
beginning the HSC mandate was limited to tackli ng 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 Comito logy committee. Representatives of the Health 
authorities of the Member States meet on a regul ar 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 an d response planning in the field of generic 
preparedness, influenza preparedne ss, 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 Committe e during the period from November 2009 to 
December 2010" was published on 22 July 2011.
115  
2. Mandate  
According to the Council Conc lusions on HSC of 22 February  2007 the current Terms of 
Reference are the following: 
• exchange information on health-related th reats from acts of terrorism or any 
deliberate release of biological or other agents with intent to harm health; 
• share information and experience on prep aredness 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; 
                                                 
112 Presidency Conclusions of 15 November 2001 on bioterrorism: 
(http://europa.eu/rapid/pressReleasesAction.do?r eference=PRES/01/415&fo rmat=HTML&aged=0&lg=
es&guiLanguage=en ) 
113 Council Conclusions of 22 February 2007 on health security committee: 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf  
114 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  
115 http://ec.europa.eu/health/preparedness_re sponse/docs/hsc_activities_2009-2010_en.pdf  
 
EN 55   EN • facilitate and support coordi nation and cooperation efforts and initiatives undertaken 
at EU and international leve l and help contribute to thei r 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 h ealth areas. It exchanges inform ation 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 th e Health Security Committee are the following : 
In January 2010 discussion about the investigatio n 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 th e 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 orde r 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 th en 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, th ere is not voting according to the usual 
principles of comitology and hence the Co mmittee 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 th eir own assessment of the risk and capacity to cope with. As 
proven by evaluations at the level of Memb er 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 us e of "mutual agreements" would have been 
more effective and less costly for Europe. 
 
EN 56   EN 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 fo r 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 structur es in all relevant sectors to ensure that work 
is taken forward in the most appropriate forum, avoiding duplic ation 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 Memb er States and the Commission 'to strengthen 
their coordination in facing public  health emergencies of intern ational concern within the EU, 
as defined in the Internationa l Health Regulations (IHR) 2005. 
The Council also invited the Commission to "tak e into account the inter-sectoral dimension of 
preparing for pandemic influenza..., to develop the system of monitori ng, preparation, early 
warning and response at European level to ad apt 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 evalua tion 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 hea lth 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 th e EU, taking into account lessons learned from 
the A(H1N1) pandemic, the national and Europe an 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 pr eparedness for a pandemic and to reducing the 
impact of a pandemic on society, to ensure th at the response is flex ible 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 antivir al medication which allows Member States, 
on a voluntary basis, common acquisition of these products or common approaches to 
contract negotiations with the industry, cl early addressing issues such as liability, 
availability and price of medicina l products as well as confidentiality; 
                                                 
116 Council conclusions of 22 February 2007 on Health Security Committee, 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf  
117 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  
118 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  
 
EN 57   EN – 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 th e application for mark eting authorization, 
the requirements on packaging and leaflets, the av ailability of data from clinical trials, the 
scientific pre- and post marketing evaluati on 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 so lution 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. 
 
EN 58   EN Annex 4: Existing legal framework for co mmunicable diseases, Decision 2119/98 and 
European Centre for disease prevention and control (ECDC) and implementation of the 
framework 
Since 1998 legal provisions on communicable dis eases 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: Antimicr obial 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 Re sponse System (EWRS), the EU Rapid Alert 
System for communicable diseases. Such notifi cation helps in coordi nating 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 Me mber 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 comm unicable 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 help s 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 sc ientific based assessme nt of the situation. 
This assessment, called "Risk Assessment" is shared through the EWRS and it is the basis to develop and choose, with the c oordination of the Commission, th e best options to respond at 
EU level to the event.  
                                                
 
119 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) 
120 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/co mmunicable_diseases/early_warni ng/comm_legislation_en.htm ; Most 
recent examples of the use of the mechanis m are the pandemic H1N1 event in 2009; 
http://ec.europa.eu/health/comm unicable_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 ar e 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 includ e management of pandemic H1N1 in 2009 and a 
multi state incident of an thrax contaminated heroin 
http://ec.europa.eu/health/prepare dness_response/hsc/index_en.htm  
121 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) 
 
EN 59   EN A number of events illustrate the benefits  of the mechanism currently in place.  
EU case definition s of specific conditions are agreed upon so that all the Member States apply 
the same criteria in reporti ng an outbreak. This has been pr oved of crucial importance not 
only during the recent E. coli outbreak (2011), bu t 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 wa s of pivotal importance to quickly identify all 
people exposed in orde r to treat them.  
During the H1N1 influenza pandemic the adoption of technical guidance documents  on risk 
group to be vaccinated, school closure and tr avel 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 s ecured informatics tool like the EW RS has helped Member States to 
implement contact tracing activi ties of persons who have been contaminated or exposed to 
infectious agents in order to have them treated  with a matter of urgenc y. 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 a nd control of communicable diseases under 
Decision 2119/98/EC 
The Community network two part s: (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 diseases
122. 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 obl igation to provide all necessary information for surveillance purposes 
to the ECDC under the founding regulation
123. 
(2) The Early Warning and Response System (EWRS) is a network formed by the Commission and competent public health author ities in each MS responsible for measures 
which may be required to protect public health. It is responsible for notifi cations at EU level 
                                                
 
122 See Article 1 of Decision 2119/98/EC. 
123 See Article 2 of Regulation (EC) 851/2004 
 
EN 60   EN of events of communicable diseases of Commu nity relevance and of related public health 
measures as well as for coordina tion of responses at EU level124. 
In addition to the Community network for the prevention and cont rol of communicable 
diseases, Decision 2119/98 has empowered the Comm ission 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 Counc il and the European Parliament On 
the operation of the Early Warning a nd Response System (EWRS) of the 
Community Network for the epidemiol ogical surveillance and control of 
communicable diseases during 2 006 and 2007 (Decision 2000/57/EC) 
http://eur-
lex.europa.eu/LexUriServ/LexUri Serv.do?uri=COM:2009:0228:FIN:EN:PDF   
• Report from the Commission to the Counc il and the European Parliament On 
the operation of the Early Warning a nd Response Systems (EWRS) of the 
Community Network for the epidemiol ogical surveillance and control of 
communicable diseases during years 2004 and 2005 (Decision 2000/57/EC) http://eur-
lex.europa.eu/LexUriServ/LexUri Serv.do?uri=COM:2007:0121:FIN:EN:PDF   
• Report from the Commission to the C ouncil and the European Parliament on 
the operation of the Early Warning a nd Response System of the community 
network for the epidemiological survei llance and control of communicable 
diseases (decision 2000/ 57/EC) during 2002 and 2003 http://eur-
lex.europa.eu/LexUriServ/LexUri Serv.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 th e Health Security Committee. Action requested 
in these two areas is purely technical and hence not subject to this impact assessment.  
                                                 
124 In the area of communicable diseases the EWRS perf orms the same activities as the EU Health Security 
Committee with the exception of pr eparedness matters (see the terms of reference of the EU Health 
Security Committee). 
125 These provisions will need to be reviewed in acco rdance with the rules on non- legislative acts (see inter 
alia Articles 290 and 291 of TFEU. 
 
EN 61   EN Annex 5: The International Health Regulations (IHR)126 
Since 15 June 2007 the Internationa l Health Regulations (2005) have entered into force. This 
legally-binding agreement provides a new framewor k for the coordination of the management 
of events that may constitute a public health emergency of internati onal concern (PHEIC) and 
is expected to improve the capac ity of all State Part ies who have signed it (194 worldwide) to 
detect, assess, notify and respond to public heal th 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, ra diological, environmental etc.) as well as all 
communicable diseases causing public health emergencies. 
Countries that are States Par ties to the Regulations have tw o years to assess their core 
capacities and develop national ac tion plans followed by three years to meet the requirements 
of the Regulations regarding their national su rveillance 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 requirement s that a State Party should have in order 
to detect, assess, notify and respond to public he alth 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 additi on EU criteria for notification s hould be established as the IHR 
criteria for notification are ve ry basic so that developing countries can cope with the 
requirements. Health threats in the past considered as threat s at European level were not 
notified under the IHR. For example this was th e case for Melamine contaminated milk from 
China. 
However there are weaknesses in the IHR for ex ample they do not require MS to transfer 
biological material for analysis  in the sophisticated laborator ies 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 regi onal level. For example under th e 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/  
 
EN 62   EN Annex 6: Examples of effects  
Table 1: Examples of effects fr om communicable disease outbreaks 
Type of threat Year of event Affected 
persons Health impacts Economic and other 
impacts 
Mad cow 
disease and links to 
Creutzfeld- 
Jakob disease 1993-1998 1994 - 2008 at 
EU level: 209 cases
127 
 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. 
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 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  
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. The estimated income 
loss ranges from 
US$12.3-28.4 billion for 
East and Southeast Asia as a whole
133 
Quarantine measures; 
travel restrictions 
Pandemic Influenza 2009/2010 A minimum of 
2900 deaths in Heavy burden on health 
services including Economic and societal 
disruption, particularly in 
                                                 
127 http://ec.europa.eu/food/animal/diseases/strateg y/docs/Public_health_E_CJD_Surveillance_en.pdf  
128 http://www.who.int/csr/disease/avian_influenza/country/cases_table_2011_08_02/en/index.html  
129 http://www.who.int/csr/disease/avian_influenza/country/cases_table_2011_08_02/en/index.html  
130 UNESCAP - United Nations Economic and Social Commission for Asia and the Pacific. Economic 
Impact of Avian Flu: Global Programme for Avia n Influenza and Human Pandemic: Health, Nutrition 
and Population in East Asia and the Pacific ( http://www.worldbank.org/ ). 
131 http://ideas.repec.org/h/izm/prcdng/200610.html  
132 http://www.who.int/csr /sars/country/table2004_04_21/en/index.html  
133 http://www.adb.org/Documents/E DRC/Policy_Briefs/PB015.pdf  
 
EN 63   EN H1N1 
(2009)134 the EU with 
18000 deaths 
worldwide135 
136 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. Mexico
138; school 
closures; disruption for 
tourism and travel. 
E. coli  STEC 
O104 2011 3.910 human 
cases and 46 deaths within 2 
months
139 
 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 Huge impacts on 
vegetable/agriculture sector in the EU; 227 
Mio EUR compensation 
scheme established by Commission to date
141; 
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 million
142 
 
                                                                                                                                                         
134 All evaluations related to pandemic influenza H1N1 are published at:  
http://www.ecdc.europa.eu/en/hea lthtopics/pandemic_preparedness/pandemic_2009_evaluations/Pages/
pandemic_2009_evaluations.aspx   
135 http://www.who.int/csr/don /2010_07_02/en/index.html  
136 http://www.ecdc.europa.eu/en/activities/scia dvice/Lists/ECDC%20Reviews/ECDC_DispForm.  
aspx?List=512ff74f%2D77d4%2D4ad8%2Db6d6%2Dbf0f23083f30&ID=789  
137 http://www.ccomptes.fr/fr/CC/documents/RPA /5_lutte_contre_la_grippe_A_H1N1.pdf  
138 http://web.worldbank.org/WBSITE/EXTERNAL/NEWS/0,,content  
MDK:20663668~pagePK:34370~piPK:42770~theSitePK:4607,00.html  
139 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/List s/ECDC%20Reviews/ECDC_DispForm.aspx?List=512
ff74f%2D77d4%2D4ad8%2Db6d6%2Dbf0f23083f30 &ID=1166&RootFolder=%2Fen%2Factivities%2
Fsciadvice%2FLists%2FECDC%20Reviews  
140 http://www.eurosurveillance.org/Vi ewArticle.aspx?ArticleId=19889  
141 http://europa.eu/rapid/pressReleasesAc tion.do?reference=IP/11/938&format=  
HTML&aged=0&language=EN&guiLanguage=en  
142 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 
 
EN 64   EN Table 2: Examples of effects of threats caus ed by chemical, biological and environmental 
events 
 Year of 
event Affected 
persons Health impacts Economic and other impacts 
Volcanic ash 
clouds 2010  Risk of exposure 
affecting persons with respiratory diseases; 
delays in delivery of 
organs for transplants because of 
interruption of 
transport
143  100,000 flights cancelled, 10M 
passengers unable to travel; disruption of business estimated up 
to 2.5 Billion €
144 
Red 
Aluminium 
sludge spill in 
Hungary and in Danube 2010 8 persons 
died and 130 
individuals 
some in critical 
condition 
were treated 
in hospitals 
for burn injuries.
145 Exposure of 
population in several 
Member States to risk 
of poisoning  Damages to the environment; loss 
in production capacity as 
employees were unable to work due 
to intoxication. 
Heat wave  2003 70,000 
excess deaths 
reported from 12 
European 
Countries. 
146 Large numbers of 
elderly persons and 
persons with chronic disease requiring 
intensive care or 
suffering premature death. Estimation by United Nations 
Environmental Programme for the 
European Region was 13 Billion €.
147 
Fire at the 
Buncefield 
Fuel Storage Depot, 
England  December 
2005 244 patients 
attended 
accident and emergency 
services in 
hospital. Minor 
injuries. 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 Explosion heard in France. Smoke 
cloud crossed Channel. Potential 
for international impact (France, Belgium, Netherlands as well as 
UK). 
                                                 
143 http://www.sergas.es/gal/DocumentacionTecni ca/docs/SaudePublica/incidencias/ECDC%20  
Threat%20Assessment%20-%20Volcano%20in%20Iceland.pdf ; 
http://www.efsa.europa.eu/en/efsajournal/doc/1593.pdf  
144 http://europa.eu/news/transport/2010/04/20100421_en.htm  
145 http://register.consilium.europa.eu/pdf/en/10/st14/st14910.en10.pdf  
146 http://www.euro.who.int/en/what-we-do/health-topic s/environment-and-health/Climate-change/facts-
and-figures  
147 http://www.grid.unep.ch/product/publication/download/ew_heat_wave.fr.pdf  
148 http://www.hpa.org.uk/web/HP AwebFile/HPAweb_C/1194947375551  
 
EN 65   EN Annex 7: EU mechanisms and strategies fo r disaster prevention and control – the 
security framework within the European Commission 
Several principle areas under the TFEU are dealing with EU disa ster prevention and control. 
Mechanisms related with EU disaster preventio n and control cover civil protection (Article 
196), solidarity clause (Article  222), EU financial assistance (Article 122), humanitarian aid 
(Article 214), cohesion policy and home affair s. In addition, TFEU lays down provisions on 
EU's external action in relation with international cooperation on a ssistance in case of natural 
or man-made disasters (Article 21). Furthe rmore, 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 he alth and develop capacities to manage crises149. A 
non-exhaustive list includes the civil protection mechanism, the Internal  Security Strategy, the 
Cohesion and Solidarity Funds, pa n-European alert networks su ch as ECURIE, to name only 
a few150.  
All these are managed by the responsible Commi ssion services. Furthermore, over twenty EU 
Agencies provide information and advice, oversee operations and support policymaking.  
Crisis management coordination at cor porate level is done through ARGUS, the 
Commission's crisis management corporate system.  
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 specif ic coordination process and an information network involving 
Directorates General and serv ices in the Commission. Followi ng five years of operations, 
ARGUS is currently under revi ew among others at improving the Commission's preparedness 
capacity. 
The Commission ensures broader internal coordination by mean s of an interservice group on 
Community Capacity in Crisis Management whic h brings together all relevant Directorates-
General and services as well as EU Agencies. In this gr oup DG SANCO has informed on the 
health security initiative and has also receive d input for the impact assessment. The health 
security initiative is part of the overall EU m echanisms and strategies for disaster prevention 
and control. It will lead to intensified inter-ac tion 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: 
• EU Agencies, such as the European F ood Safety Authority (EFSA), European 
Medicines Agency (EMA), European Mari time Safety Agency (EMSA), European 
Monitoring Centre for Drugs and Drug A ddiction (EMCDDA), European Agency for 
Safety and Health at Work (EU-OSHA ) and the European Chemicals Agency 
(ECHA);  
                                                 
149 See detailed information in annex 7 
150 For further details, please see the "Inventory of  Crisis Management Capacities in Commission and 
Agencies" 
151 COM(2005) 662 final 
 
EN 66   EN • Designated networks such as the Animal  Disease Notification System (ADNS), 
Rapid Alert System for Feed and F ood (RASFF), European Telecommunication 
Network in Pharmaceuticals (EUDRANET) , Rapid Alert System for Non-Food 
Dangerous Products (RAPEX), Monitoring a nd Information Centre (MIC), and RAS-
CHEM, which is a rapid alert system  for chemical health risks;  
• Scientific committees (on consumer produc ts, 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 th e Commission and various EU Agencies, such as the European 
Centre for Disease Prevention and Control, th e 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 mann er. Especially, they do not provide a coherent 
and satisfactory basis for deci sions 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 w ith authorities and agencies responsible for 
public health in the Member St ates 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 pl ace the EU Internal Security Strategy, which makes 
specific reference to the h ealth security initiative. 
This Internal Security Strategy was adopted in November 2010 by a Commission 
Communication. It establishes a f our year strategy to help incr ease Europe's resilience to 
crises and disasters, including hostile or accidental re leases of disease ag ents and pathogens. 
The Health Security Initiative is  explicitly mentioned as an elem ent 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 agen cies to reinforce effective fight and 
prevention of serious and organised crime and te rrorism and to strengthe n resilience to natural 
and man-made disasters. It will be an important element in establishing a coherent risk management policy linking threat and risk a ssessments to decision making as envisaged by 
the EU Internal Security Strategy.  
Action 2 of objective 5 is in particular rele vant for the Health Security Initiative: 
OBJECTIVE 5: Increase Europe's res ilience 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 a nd 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 improve ments to long-standing 
                                                
 
152 http://ec.europa.eu/health/scientific_committees/policy/index_en.htm  
 
EN 67   EN crisis and disaster management practices in te rms of efficiency and coherence. They require 
both solidarity in response, and responsibilit y in prevention and preparedness with an 
emphasis on better risk assessment and risk manage ment 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 devel op, 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 appr oaches 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 hea lth 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, Radiologi cal and Nuclear Security in the European 
Union – an EU CBRN Action Plan" accomp anied by the Commission Staff Working 
Document on "Bridging security and health: towards identification of good practices and 
recommendations on response to CBRN incide nts and security of CBRN substances"153.  
This plan is built on an all h azard approach to combat threat s for society and includes health 
threats preparedness and response as one of its  main columns. Risk prevention and control 
structures developed in the heal th 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' au thorities 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 in tervention coordination in civil 
disaster response through the EU Civil Protection Cooperati on Mechanism is growing. The 
initiative will strengthen capacity  in responding to health threats in a civil disa ster situation. 
In the area of civil protec tion, 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 st ronger European disaster 
response: the role of civil prot ection and humanitarian assistance"155. EU co-operation in the 
field of civil protection aims to  better protect people, their en vironment, property and cultural 
                                                 
153 COM(2009) 273 final 
154 COM(2008) 130 final 
155 COM(2010) 600 final 
 
EN 68   EN heritage in the event of major natural or manm ade disasters occurring bo th inside and outside 
the EU. 
Close cooperation between DG ECHO, DG SA NCO, backed up by EC DC, 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 e quipment in the course of the pandemic 
(2009) H1N1;  
• refugees arriving on EU terr itory following turmoil in Northern African states;  
• toxic spill of red alumin ium sludge in Hungary;  
• avian influenza infections;  
• Cholera outbreak in Haiti, Dominican  Republic, and danger to visitors.  
C. There are also possible synergies between th e Health Security Initiative and EU activities 
in the field of external relations  under the umbrella of the Eu ropean External Action Service 
(EEAS).   
The Health Security Initiative will appropria tely take into account these EU external 
cooperation activities for health crises preven tion and responses with  third countries and 
explore synergies with the numerous bilatera l 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, tu berculosis and other di seases), 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 st arted 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). Po ssible synergies will  be explored under 
the Health Security Initiative with the ac tivities of these re gional CBRN Centres of 
Excellence.  
 
EN 69   EN Annex 8: Business continuity and preparedne ss planning at EU and international level  
Whole-of-Society approach of the WHO an d the Towards a Safer World Initiative 
The World Health Organization (WHO) has addr essed 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 te le-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 Septembe r 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 ar e not sufficiently consulted and engaged in 
national planning. In many countri es, 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 prep aredness planning. The 
current situation seriously hampers proper prep aredness 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 Internati onal Monetary Fund (IMF) in 2006158 found that in many 
countries, business continuity pl anning has not yet addressed the specific risks arising from a 
pandemic, particularly from possible high abse nteeism and that the level of preparedness 
among national authorities and financial institu tions 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 undertak en all the necessary steps to in crease resilience. In most of 
these cases, decisions over si gnificant 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 p ublic institutions is just beginning. 
                                                 
156 WHO, Whole-of-society pandemic readiness - WHO guidelines for pandemic preparedness and 
response in the non health Sector , Geneva, July 2009, 18 available on 
line:http://www.who.int/influenza/preparedness/pandemic/2009-
0808_wos_pandemic_readiness_final.pdf. 
157 Towards a safer world: Beyond Pandemics: A Whole- of-Society Approach to Disaster Preparedness: 
http://www.towardsasaferworld.org/site s/default/files/tasw _book_web_9.23.pdf 
158 http://www.imf.org/external/pubs/ft/afp/2006/eng/022806.pdf 
 
EN 70   EN 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 pos sible 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, Norw ay and Switzerland. The report concluded that 
the advice on preparedness given to businesse s in the non-health sector by European 
governments and independent orga nisations, such as consultancy firms, academic bodies and 
trade unions, is insufficient to ensure that th e private sector is equipped to deal with a 
pandemic. Over a third of all governments su rveyed offered no advice at all and only 8 
provided significant levels of advice. 
A work shop on inter-sectoral preparedness or ganised under the Spanish presidency in May 
2010 concluded that there is a lack  of data on the level of prep aredness planning in critical 
sectors involved in the response to a pandemic.  
The European Centre for Disease Prevention a nd Control (ECDC) has facilitated systematic 
self assessments of pandemic pr eparedness 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 bus iness continuity plans to maintain essential public 
services during the sustained stress of a pandemic (e.g. tr ansport, utilities, police, 
etc).  
• only 40% have national contingency plans for maintenance of non-health essential 
services, such as power supply, food di stribution, etc, publicly available. 
• 79% have cross-sectoral national planni ng structures for pandemic preparedness 
rather than just in the health sector. 
• only 61% have in place cross-sectoral m echanisms 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 http://www.pandemie-
grippale.gouv.fr/IMG/pdf/PROPOSALS_OF_THE_EUROGRIPPE_SEMINAR.pdf 
160 http://www.lshtm.ac.uk/news/2 008/pandemicfluprepare.html 
161 Technical Report Pandemic Influe nza Preparedness in the E U/EEA: 
http://ecdc.europa.eu/en/publications/Publications/0712_TER_Pandemic_Influenza_Preparedness_in_E
U_EEA.pdf  
162 http://eur-lex.europa.eu/LexUriServ/LexUriSe rv.do?uri=OJ:L:2008:345:0075:0082:EN:PDF  
 
EN 71   EN The Directive establishes a common procedure for the identification and designation of 
European Critical Infrastructure – ECI –in tw o 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 maintenan ce of vital societal functions, health , safety, security, 
economic or social well-being of people, and the disruption or destru ction 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 forw ard and participates in the id entification and designation of 
relevant ECI; 
- Designated ECI must implement an  Operator Security Plan (OSP); 
- Each Member State performs threat assess ments concerning specific sub-sectors in which 
ECI have been identifi ed 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 concerni ng the protection of ECI. A review of the 
directive is foreseen for 2013.  
 
EN 72   EN 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) a nd the second Health Programme (2008-2013). 
With the health programmes DG SANCO has suppor ted 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 re sponse capacity against chemical, biological, 
radio-nuclear (CBRN) threats/attacks. 
It is planned that for important elements of th e initiative, specific acti ons 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 tr ansversal objective on 
implementation of EU legislati on. 2-4 Million € per year are envisaged internally for these 
purposes. 
Below some examples of successful prepared ness projects which have been funded in the 
past: 
– Laboratory network (EURONET P4): Biosafet y Level-4 (P4) facilities, which allow 
the containment and the study of very da ngerous biological ag ents (e.g. smallpox, 
ebola) are very expensive to build and main tain 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 th at 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 wa sted and lives lost. 
Being able to know early that a health emer gency situation has begun is crucial to be 
able to respond appropr iately. 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 investigati on and follow-up of potential outbreaks. 
– The CARRA-NET (Chemical and Radiation Ri sk Assessment NETwork) project is 
intended to help to develop a coordina ted and robust prepar edness and response 
capacity within the EU Member States (M S) in order to e ffectively respond to 
chemical and radio nuclear incidents, esp ecially those of cro ss-border significance. 
The project addresses issues such as the timely detecti on, 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 en sure mutual information on measures 
envisaged and coordination of such measures. 
 
EN 73   EN – SHIPSAN: SHIPSAN TRAINE T aims to both facilitate the implementation of 
International Health Regulations to e nhance the common EU policy, but also to 
create a common European framework for sh ip sanitation inspection, surveillance 
and the control of outbreaks. Their work is expansive, covering guidelines for 
inspections, food safety and hygiene, su rveillance of communicable diseases, 
medical facilities, outbreak plans, pest and waste. 
– EpiSouth-Plus: EpiSouth-Plus is unique am ong 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, includi ng non-UE countries as  well as all three 
WHO Regional Offices that cover the Medi terranean. In additi on to facilitating 
epidemiological communication and practical  training, this regional approach 
strengthens solidarity and c ohesion within the European Community and between 
EU and non-EU countries, especially for in formation sharing rega rding cross-border 
public health threats and for the implemen tation 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 appr oaches to early warning and preparedness 
by bringing together EU and non-EU count ries in all the planned activities. 
EpiSouth-Plus will fill the gaps and needs that were identified in the previous years. In particular, the laborator ies in the Mediterranean re gion will be better connected 
and coordinated to ensure the developmen t of cross-border la boratory services, 
enhance complementarity among vertical a nd fragmented laboratory networks and 
help to overcome of national logistic and le gislation constraints.  Common procedures 
in interoperable Generic Preparedness and Risk Management Plans will be promoted 
to reduce inter-country variability, e nhance capacity building and cross-border 
concerted actions and facil itate the elaboration of na tional plans and communication 
strategies.  
– ASHT: Large contamination events of ha zardous chemicals re quire a rapid alert 
system in order to trigger a rapid and appr opriate response, to pr otect the health of 
potential victims of the deliberate as well  as accidental rel ease 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 fo r Chemical Health Threats 
(RAS-CHEM), which now includes a risk a ssessment 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 incide nts that could cross borders and affect 
citizens throughout the European Union.  
– ORCHIDS: In the event of a release of a hazardous s ubstance, large numbers of 
people will need to be decontaminated quick ly – and effectively – so as to halt the 
spread of contamination and prevent fu rther harm, as well as to prevent the 
contamination of emergency responders an d 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  
 
EN 74   EN 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 
specific objectives 
to reinforce the response to all serious cross-border threats to health based on a comprehensive and coherent approach to preparedness and response planning, ri sk monitoring and 
assessment as well as risk management including risk communication 
preparedness and response planning risk monitoring and assessment risk management and crisis communication 
to develop a common approach to preparedness planning at EU level for all serious cross-border thre ats to health ensuring 
coherence and interoperability among sectors at EU level and 
between Member States including improving equitable access to 
medical countermeasures to create conditions to ensure a coherent and 
comprehensive identification and 
notification of health threats and evaluation 
of their risks to health , especially in case of 
health-related crises w ith 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 im prove 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 ac tivities 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 ra pid exchange and agreement on 
communication messages and strategies 
 
EN 75   EN  Annex 11: Notification of serious cross border health threat s to the WHO under IHR 
Number of IHR events/ notificati ons by type of event and year during 15 June 2007 - 30 July 2011 
Type of event  June- Dec  
2007 2008 2009 2010 Jan-July  
2011 Grand Total  
Animal    1 3     4 
Chemical        1   1 
Food Safety  4 1 3 3 1 12 
Infectious  7 12 90 43 25 177 
Product  2 2 1     5 
Undetermined          1 1 
Grand Total  13 16 97 47 27 200 
Communicable diseases notified und er IHR are 177, Communicable diseases notifie d under 2119/98/EC through EWRS are 785; so 785:  177 = 4,5. 
That finally means that the events reporte d through EWRS under the EWRS  criteria are 4,5 times more than the events reported un der 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. 
 
EN 76   EN Annex 12: Problems and public health consequences 
 
 
EN 77   EN Annex 13: Overview of measures proposed under the three options  
 Option 1: Status quo:  
 Option 2: Soft instruments  Option 3: Establish common EU legal framework covering all serious 
cross-border threats to health  
Preparedness and 
response planning Follow up of implementation of 
guidance on preparedness;  
organise exercises and training; 
exchange best practice; Shared approach on preparedness 
planning,  
identify core capacity standards related to 
IHR requirements; guidance on improved cross-sectoral 
preparedness and interoperability, 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;.
 
Procurement of 
medical 
countermeasures Support for Member States, e.g. 
in preparing tender 
specifications; promote production capacity for 
pandemic influenza vaccines;  Ditto option 1, plus:  
increase support for Innovative Medicines 
Initiative and/or EU stockpile of medical countermeasures,  
better exchange of information on 
contractual conditions ; Establish legal basis for EU coordination of joint action for purchasing 
medical countermeasures; 
 
Risk monitoring and assessment No strengthening of existing 
notification and monitoring 
mechanisms and structures; 
risk assessment on the basis of ad hoc support networks 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; 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);  
Risk management Maintain current informal 
mandate of the Health Security 
Committee (HSC) Replace HSC by expert group;  Improve cohere nce and coordination of risk management; 
EU action to cover advisory activ ities 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; 
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 ; Develop common communication strategies, integrate communicators 
into crisis management process and link communicators directly to risk managers / decision makers;  
 
EN 78   EN Annex 14: Opinions of stakeh olders on the three options 
The views of the stakeholders, as gathered  through the consultati on, 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 al l the respondents. The 
same opinion was clearly expressed th rough the 2010 consultation on pandemic 
preparedness, where 98% of all respondents to ok 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 we ll with other countries in the EU. 90% of all 
respondents felt that the interopera bility of Member States plan s 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 consultati on 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 coordi nating role when a cross-border aspect was 
involved. 
The majority of the stakeholde rs (90%) are in favour of a be tter evaluation of public health 
issues resulting from all se rious 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 inte gral part of risk management at EU level; 
b. providing more guidelines on risk a nd crisis communicatio n at EU level;  
c. supporting the communication efforts of Me mber States and othe r bodies dealing with 
health measures;  
d. establishing networks and improving comm unication with healthcare professionals; 
e. improving communication with the media; f. improving the consistency of comm unications between Member States.  
In addition to the points mentioned under options  1 and 2, the views of  the stakeholders, as 
gathered through the cons ultation, support the following actions, as  described in option 3: it is 
important, according to the members of the HS C and EWRS network committee, to ensure 
interoperability of the alert/notification system s, in order to avoid a wide range of differing 
 
EN 79   EN 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 le vel should be better interconnected across the 
sectors in order to link the different di sciplines (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 re spondents believe that improved 
coordination of national public health measures (prevention, diagnosis, treatment, control) 
among Member States is also need ed in the event of a cross-bor der health thre at. 79% of all 
respondents think that a coherent  risk management mechanism for serious cross-border public 
health threats at EU leve l would create added value. 
 
EN 80   EN 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 warn ing of and combating 
serious cross-border threats to health. 
- coordinate among themselves actions to enc ourage the consistency, interoperability and 
multi-sectoral aspects of preparedness and response planning at national level for the 
perspective of protection and impr ovement of human health, in part icular in critical sectors of 
society. 
- for core capacity requirements for preparedne ss 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 direct ed 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 pro cedures for information, consultation and 
coordination in relation to prep aredness and response plans, in order to ensure consistency, 
interoperability and multi-sectoral aspects of na tional plans at EU level, including adequate 
coherence between specific nati onal plans developed for the crit ical sectors of the society.  
In the area of risk assessment
, the Commission: 
- will make available to the competent authori ties of the Member States  an assessment of the 
risks to public health ca rried 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 availabl e or not comprehensive or not 
consistent with another assessment carried ou t 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 expos ure to the threat, asse ss 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 pub lic health measures and assess the potential 
impacts of those options on the critical sectors of society. 
 
EN 81   EN Risk management  
Member States consult each other in liaison with the Commission in order to coordinate 
national responses to serious cro ss-border threats to health , they consult Member States and 
the Commission on the nature, purpose and scop e 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 jo int action, relating to 
a serious cross-border threat to health; e.g. de claration of public health emergency at EU 
level, coordination of prevention and control campaigns, including vacc ination; coordinated 
information and communication initiative, in cluding 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 hea lth caused by the serious cross-border threats 
to health, and respect the res ponsibilities of the Member Stat es for the definition of their 
health policy and for the organization and deliv ery 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 heal th emergency of international concern; 
(b) guidelines on communication with the public and on good pract ice for the public. 
The Health Security Committee would: (a) advise the Member States and the Commissi on, 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. 
 
EN 82   EN Annex 16: Description of actions proposed under the op tions and their implications for the health sector 
Option 1: Status quo: Maintainin g 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 
and ensuring implementation of existing guidance as regards generic and pandemic 
preparedness. Surveys and development of 
indicators would be supported.  
Organising exercises where public health crises 
are simulated, and exchange of best practice 
would continue. 
Shared standards and EU tailor-made criteria 
for notification in order to ensure implementation of the requirements as set out 
in the IHR would not be addressed. 
 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 in formation, guidelines, case studies and results of exercises to improve their 
national planning in relation to each ot her. 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. 
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 pl anning 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 arrangem ents with WHO would prevail over EU coordination.  
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 th e Commission, the differences and incompatibilities between 
MS could prevail in the abse nce of a robust solution. In addition, the most recent over view 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 evidence
163]. 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 w ill 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, th e evidence of a lack of a join t approach was demonstrated in  the evaluation report on H1N1 
(2009) in paragraph. 7.2
165 , where only seventeen MS report that consultation occurred between them and neighbouring 
European countries in the development of plans during the preparedness phase. 
                                                 
163 http://ecdc.europa.eu/en/publications/Publications/0701_TER_Pandemic_Influenza_Preparedness.pdf  
164 European Parliament resolution of 8 march 2011 on evaluation of the management of H1N1 influenza in 2009-2010 in the EU (2010/ 2153(INI)) 
165 http://ec.europa.eu/health/c ommunicable_diseases/docs/ assessment_response_en.pdf  
 
EN 83   EN 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 effec tively. (See conclusions of Fr ench 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 thei r preparedness plans). Several priorities were identified as leading to critical 
distances, among which seve ral are Inter-sectoral".)166 
The impact of option 1 would be low as the current systems would be maintained but not strengthened.  
To improve equitable access to medical 
countermeasures, the Commission would continue to support Member States' 
cooperation, e.g. in th e preparation of their 
national tender specifications for vaccine 
procurement.  
The Commission would also continue to 
promote improved production capacity, through 
e.g. improved vaccination coverage for 
seasonal flu which co uld influence capacity 
building for pandemic influenza vaccine 
production. Maintaining the status quo would mean that the access to medi cal countermeasures will be le ft in the responsibility of 
the Member States with no EU component to improve the pu rchasing 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 proc urement experience to improve th e 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 smalle r Member States. Building on this experience, the Council 
subsequently called on the Commission in October 2009
167 to continue to support procur ement processes for the vaccine 
for those Member States, candidate countr ies, 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 Co mmission 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 Me mber States have a vaccination covera ge for these groups higher than 50%170). 
This process is intended to put in place of higher level of production capacity for vacci nes in Europe in case of a 
                                                                                                                                                                                                                                                    
166 http://www.pandemie-grippale.gouv.fr/IMG/pdf/ PROPOSALS_OF_THE_EUR OGRIPPE_SEMINAR.pdf  
167 http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/110500.pdf  
168 http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/111599.pdf  
169 http://eur-lex.europa.eu/LexUriServ/LexUriSe rv.do?uri=OJ:L:2009:348:0071:0072:EN:PDF  
170 http://www.eurosurveillance.org/images/dyna mic/EE/V13N43/Venice_Survey_Figure2.jpg  
 
EN 84   EN 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 v accination strategies for seasonal flu.  
In addition, the Commission would continue to suppor t through the EU Research and Development Framework 
Programme which encourages the deve lopment 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.  
The EU would continue to work with the 
existing notification and monitoring 
mechanisms and structures without strengthening coordination among concerned 
policy areas.  
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. 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. Al erts from rapid alert systems for other policies will not be 
notified systematically to the public health authorities for th e 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 perspec tive. 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 response
172. In addition, real lif e situations such as the forest fires in 
Russia and the volcanic eruption in Icela nd 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 H ealth 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 unsustainab le 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 ad dition these informal public health systems ma y duplicate other reporting systems in the same 
fields based on legal requirements in those policy fields
173.  
                                                                                                                                                                                                                                                    
171 http://ec.europa.eu/research/health/infectious-dis eases/emerging-epidemic s/fp7projects_en.html  
172 Exercise Iridium; http://ec.europa.eu/health/preparedness_response/docs/iridium_1_2011_frep_en.pdf  
173 eMars - http://emars.jrc.ec.europa.eu/ ; MIC - http://ec.europa.eu/echo/civil_protection/civil/prote/mic.htm ; CleanSeanet http://www.emsa.europa.eu/operations/marine-
pollution/cleanseanet.html ; SEIS http://www.eea.europa.eu/about-us/what/sha red-environmental-information-system  
 
EN 85   EN As regards risk assessment, this option would continue to re ly on networks whose expertise can be gathered on an ad 
hoc basis. This would not lead to strengthening capacities eith er 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 inappr opriate risk assessment and response. 
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. Under this option, risk management will continue to be ensured by two existing structures, one legally based (and 
responsible for communicable diseases
174) 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 di scuss public health measures to be implemented in the MS. 
However, these measures are at times difficult to agree an d are not legally binding. An example was during the H1N1 
pandemic, when obtaining agreement in the Committee for joint stat ements on school closur e, 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 meas ures 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 partic ular 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 requ ests clarification, and if n ecessary review, of the roles, 
duties, remits, limits, relationships and responsibilities of the key actors and structures at EU level for the management 
                                                 
174 Early warning and response network, Decision 2119/98 (OJ L 268 3 10 1998, p.1) 
175 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  
 
EN 86   EN 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 Co mmittee as regards serious cross-border health threats other than communicable 
disease. Therefore, for example, in case of a serious cross-bo rder deliberate release of a biological agent (such as Ricin), 
the EU coordination through the Health Security Committee w ould 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 co mmunicator'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 European Parliament resolution of 8 march 2011 on evaluation of the management of H1N1 influenza in 2009-2010 in the EU (2010/ 2153(INI)) 
177 http://ec.europa.eu/home-affairs/summary/docs/com_2009_0273_en.pdf  
178 http://www.ecdc.europa.eu/en/hea lthtopics/mumps/Pages/index.aspx  
179 http://www.iss.europa.eu/uploads/media/The_return_of_t he_Gaddafi_and_his_chemical_weapons_spec tre_01.pdf  
180 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(95)92170-2/abstract  
 
EN 87   EN Option 2: Separate and different handling of  serious cross-border threats to health – e nhanced EU cooperation by use of soft in struments 
based on a voluntary approach   
Actions proposed as regards different 
handling of serious cross-border to health to 
strengthen the current system  Justification/Motivation of the rating and impact 
The Commission would propose to the Member 
States a shared approach on generic and 
specific preparedness pl anning, including for 
pandemic influenza. This approach would be non-binding and voluntary for the Member 
States.  
This would include identification of core 
capacity standards related to surveillance, 
notification, verification, response and collaboration activities building on and 
strengthening requirements under IHR. 
Finally, 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  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 prepar edness for pandemic influenza in line with the "whole society 
approach" of the World Health Organisation and the Treaty provi sions 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 ad dition, criteria for notification as set out in the IHR
181 would be 
adapted for EU requirements in order to ensure that all seriou s 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 vaccina tion 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 cu rrently the case. This would lead to better dissemination of data and probably 
even trigger innovative aspects but sust ainability 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 inst rument such as a Counc il Recommendation, there is an improvement of the 
preparedness situation as common indicators and arrangements can be pu t 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 
                                                 
181 http://www.who.int/ihr/annex_2_guidance/en/index.html  
182 http://eur-lex.europa.eu/LexUriServ/LexUriSe rv.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  
 
EN 88   EN more resources for preparedness planning and more developed cross-sector crisis management structures. 
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 to Member States 
cooperation, e.g. in th e 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 
The Commission could strengthen the 
purchasing power of the MS by improving the exchange of information on contractual 
conditions through the confidential platform 
CIRCA BC.  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 Initiative
183, Europe's largest public-private initiative 
aiming to speed up the development of better and safer medici nes for patients. However, these incentives will only cover 
activities related to research and development and not dir ectly contribute to improve the availability of medical 
countermeasures on the short term and theref ore 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 th e Commission has already propo sed such initiative and was 
withdrawn following political opposition from the Coun cil in 2006 on grounds of subsidiary and costs184. In other regions 
and countries similar in itiatives have however been implemented. 2 regi onal 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 oblig ing the producers to create a stockpile of essential goods 
(incl. antivirals) with marginal costs to the Government186.  
Regarding equitable access to medical countermeasures, the Co mmission could play a supportin g role to Member States 
by facilitating cooperation in the prepara tion 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 pr ovided during the influenza H1N1 (2009) pandemic which was restricted to 
working on the drafting of national tender specifications. It  allows pooling the expertis e 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 2009
187 and 2010188 which extended requests to the 
                                                 
183 http://www.imi.europa.eu/  
184 http://europa.eu/rapid/pressReleasesAction.do?reference=IP /06/732&format=PDF&aged=1&language=EN&guiLanguage=fr  
185 http://www.flu.mn/mgl/images/stories/Sudalgaa_shinjilgee/WPRO201 1_pdm/10%20ASEAN%20ASEF%20Stockpile%20Project_JICS_Beijing_Mar2 011.pdf  
186 http://www.bwl.admin.ch/themen/01009/01025/index.html?lang=en  
187 "To ensure timely availability of vaccine s 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 agreemen ts with manufacturers as the most efficien t way to proceed." "Invites the Commission to  continue to support procurement processes 
for the vaccine for those Member States, ca ndidate countries, po tential candidates and neighbouring countries who do not have a  current agreement with 
manufacturers;" http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/110500.pdf  
 
EN 89   EN Commission to develop it further. In addition, in its resoluti on 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 proc urement, 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 vaccine s 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 fo r joint procurement of vacci nes 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 requ ired because of the 
integrated nature of the EU. 
Risk monitoring and risk assessment for other 
serious cross-border th reats 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 know ledge from other rapid alert systems will be improved and 
agreements for mutual alerting will be established at EU le vel. 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 officers
191. 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 ri sk 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 he alth authorities will 
be informed earlier when alerts are notified through other EU  alert systems and vice versa an d 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 th reats 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 1
192 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 http://ec.europa.eu/health/preparedness_response/docs/council_lessonsh1n1_en.pdf  
189 European Parliament resolution of 8 march 2011 on evaluation of the management of H1N1 influenza in 2009-2010 in the EU (2010/ 2153(INI)) 
190 http://ec.europa.eu/health/preparedness_response/docs/council_lessonsh1n1_en.pdf  
191 Currently messages from the ECURIE system dealing with radiological events are transmitted by fax and therefore may not be tra nsmitted to the right responsible 
authorities of DG SANCO. 
192 http://www.who.int/csr/don/a rchive/year/en/index.html  
 
EN 90   EN 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 fundame ntal 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 contaminat ed 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 re levant 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 w ithin 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 Commissi on 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 assessmen t through a rapid alert system (RAS Chem
196)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 respon d 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 an d 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 http://ec.europa.eu/consumer s/safety/rapex/index_en.htm  + http://ec.europa.eu/food/food/rapidalert/index_en.htm  
194 http://www.eurosurveillance.org/images/dynamic/EE/V13N40/art18998.pdf  
195 http://www.who.in t/mediacentre/news/statements/2009/h1n 1_pandemic_phase6_2009 0611/en/index.html  
196 http://www.hpa.org.uk/web/HPAwe bFile/HPAweb_C/1247728923224  
197 CARRA NET Draft final report, Framework Service Contract No 2009 61 05 Lot 2 
198 http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/92911.pdf  
 
EN 91   EN border threats to hea lth caused by biological 
(other than communicable diseases199), 
chemical, environmental or events of unknown origin. No binding requirements would be 
foreseen for Member States under this option. by the appropriate experts in the appropriate setting. 
As a result of this option, the Commission would be able to recommend measures for risk ma nagement to Member States 
based on the expertise of the new expert group. Although th is will increase the sustainability of risk management for 
other threats coordination we will still have a weaker appr oach for threats other than communicable diseases, as 
measures will remain non binding for the first and binding fo r 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. 
As regards risk and crisis communication 
aspects, Member States , in liaison with the 
Commission, would develop shared communication approaches and guidelines e.g. 
sharing best practice in approaching the media.  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 report
200 as well as the European 
Parliament report201 placed particular stress on coor dination and streamlining of communi cation 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 provi de 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 The issue of preparedness and coordination measures regarding pandemic influenza would fall under the structures established b y Decision n° 2119/98/EC. 
200 http://ec.europa.eu/health/c ommunicable_diseases/docs/ assessment_vaccine_en.pdf  (TOR 2) chapter 6 p.81 and 
http://ec.europa.eu/health/c ommunicable_diseases/docs/ assessment_response_en.pdf  (TOR 1) chapter 12 p.51 
201 http://www.europarl.europa.eu/sides/ge tDoc.do?type=TA&referen ce=P7-TA-2011-0077&language=EN&ring=A7-2011-0035  
202 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 amélior ées 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 nive au de l'UE afin de rétablir la confiance à l'égard du secte ur des fruits et légumes. 
203 http://www.europarl.europa.eu/en/p ressroom/content/20110601IPR20702/html/E.-coli- outbreak-lessons-to-be-learnt-for-the-future  
204 see para 17; Council conclusions on Lessons learned from the A/H1N1 pandemic – Health security in the European Union 
(http://www.consilium.europa.eu/ue docs/NewsWord/en /lsa/116478.doc ) 
205 See paragraph 8 of the CSWP on the activ ities of the Health Security Committee during the period from  November 2009 to Decembe r 20 
(http://ec.europa.eu/health/preparedness_re sponse/docs/hsc_activities_2009-2010_en.pdf ) 
 
EN 92   EN Option 3: Establish common EU  legal framework covering all serious cross-border threats to heal th- improved cooperation and legally 
binding measures  
Actions proposed under integrated approach; 
extended EU competence option  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 and would report regularly on its 
implementation.  
Member States would consent to cooperate in cross-
sectoral preparedness and response planning through 
establishment of guidelines and indicators, the 
organisation of exchange of best practices, preparation 
of periodic monitoring and evaluation. 
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 tailo r-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 Hea lth 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 na ture. 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 cr oss sectoral cooperation to reach a cohe rent level of preparedness against the 
consequences of a serious cross-border health threat among essential services and across Me mber 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 sta ndards. Secondly, this option would result in more complete 
reporting on serious cross-border th reats 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 http://whqlibdoc.who.int/publications/2008/9789241580410_eng.pdf  
207 http://www.cabinetoffice.gov.uk/content/pandemic-flu  
208 See para 2.6. Continuité de la vie sociale et économique ( http://www.pandemie- grippale.gou v.fr/IMG/pdf/PLA N_PG_2009.pdf ) 
209 See p.29-32 for pandemic ( http://rcb.gov.pl/wp-content/uploads/2011/02/zagr_okres1.pdf ) 
 
EN 93   EN 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 co untermeasures within the 
TFEU legal framework.  In line with the lessons learnt from the Pandemic and the conc lusions 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 vacci nes. 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 fo r 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 th at participating countries have a minimum level of equitable access 
to medical countermeasures. 
• better pandemic preparedness by putting in place advance purchase agreem ents through framework 
contracts with suppliers. 
In the field of pandemic influenza vacci nes, joint procurement will result in a mo re synchronised start of the vaccination 
campaigns in the participating countries. 
The advantages of a joint procurement w ill result in a more favourab le public opinion reaction, and more confidence by 
the public. 
                                                 
210 Cour des Comptes, Sénat, Rivasi, TOR II, BE Presidency 
211 EC Green Public Procurement Training Toolkit – Joint Procurement Fact Sheet 
212 An assessment of the development of a join t procurement of pharmaceutical s in the public health sector in Jordan has demonstra ted 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 in creased significantly 
during the period concerned). Based on these initial findings, applying a joint procurement sy stem for pharmaceuticals in the p ublic health sector in Jordan confirmed its 
potential to reduce expenditures for the purchase of medicines and provide treatment continuously throughout the year. 
 
EN 94   EN In addition, along with the potential actions identified in op tion 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 cu rrently in place for risk 
monitoring and assessment of communicable diseases 
will be maintained as they stand.  
A coordination system w ould 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 enviro nmental 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 iden tify 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. 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. 
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 exis ting EU alert systems but simp ly 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 speci fic tools for other threats (biological  other than communicable diseases, 
environmental and events of unknown origin), although the fre quency 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 
events
214, and therefore require a lower proporti onate 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 th ese arise from communicable dis eases 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 appropriat e that alerts passed on an obligatory ba sis to the WHO are also passed on the 
                                                                                                                                                                                                                                                    
213 EC Green Public Procurement Training Toolkit – Joint Procurement Fact Sheet 
214 See annex 11 
 
EN 95   EN 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 addr ess 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 monitori ng 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-bord er 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 coordi nate 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 messa ges, 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 Me mber 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 http://eur-lex.europa.eu/LexUriServ/LexUriSe rv.do?uri=OJ:L:2000:021:0032:0035:EN:PDF ; annex I 
216 http://www.hpa.org.uk/web/HPAwe bFile/HPAweb_C/1247728923224  
 
EN 96   EN In this way, the current work consisting of coordination 
of public health response done by the EWRS Network 
and the Health Security Co mmittee, 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 join t 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 
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 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 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.  
 
 
 
EN 97   EN the Commission that might be implemented at national 
level.  
In addition, new and voluntary instrument for joints 
actions, in particular a mechanism for joint 
procurement of medical countermeasures, particularly 
pandemic vaccines, would be established. 
Common communication strategies would be developed; the communicators would be integrated in 
the crisis management process and would be s directly 
linked with the risk managers. 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 conv ince 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. 
 
EN 98   EN 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 St ate to decide on what percentage of the 
population it wishes to cover with a stockpile. 
The cost of a complementary EU stockpile de pends on the product to be stockpiled and the 
threat against which the countermeasure is inte nded to be deployed (d etermining the quantity 
to be stockpiled). A few cost examples ( not including maintenance of the stock): 
• 5% population coverage 'fire blanket' stoc kpile of pandemic influenza vaccines: ~7 
euro/dose, 1-2 doses needed, i.e. 175 – 300 million euro 
• 1% population coverage 'fire blanket' stockp ile of the antiviral 'oseltamivir' against 
pandemic influenza: extrapolated from a st ockpile established in Asia through the 
ASEAN217/ASEF218 organisations (where a stockpile covering 1 million people did 
cost 40 million euro), a stockpile coveri ng 5 million people would cost 200 million 
euro. 
• 0.5% population coverage 'fire blanket' stoc kpile 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 fl ow could be as follows:  
• When a Member State is facing an urgent and unforeseen need exceeding the 
capacity of the national stockpi le, it would simply make a re quest to the authorities in 
charge of the oversight of the stockpile  (e.g. the Commission or a board with 
representatives from the Commi ssion 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 in structed to transf er the requested amount (or a part 
thereof) to the MS's relevant authorities th at would be responsibl e 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 Brunei, Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, 
Thailand, Viet Nam 
218 EU + ASEAN + India, Japan, Korea, Mongolia, New Zealand, Pakistan, China (Russia and Australia 
are in the process of joining). 
 
EN 99   EN Commission to set up an EU stockpile of the an tiviral 'oseltamivir' wa s withdrawn because no 
consensus could be reached at  the Council (June 2006 Health C ouncil) on the funding source. 
As medical countermeasures are provided fr ee of charge to the public, no reimbursement 
issues are expected.
 
EN 100   EN Annex 18: Illustration of the joint procurement mechanism for medical 
countermeasures 
Legal basis for joint procurement
Participating Contracting Parties1sign 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.
On the basis of the requirements of the Contracting Parties, tender documents are drafted and
– following approval by JPSC – a call for tender is launchedParticipating Contracting Parties put forward their requirements in terms of
technical characteristics of the product and number of doses
Evaluation of tenders
Award decision
by JPSCProcurement procedure
is abandoned
Signature of framework contract(s)2
by participating Contracting Parties
1Potential Contracting Parties: Member States and the European Commission (the latter procuring medical countermeasures
on behalf of all interested EU Institutions for coverage of staff)
2A 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 ContractingParties to order the medical countermeasuresAward
procedure
is cancelled
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 themThreat emergesNO
NOYESCommission coordinates; decisions are taken by JPSC
 
EN 101   EN Annex 19: Analysis of the im pacts 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: Maintainin g 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  This option will not improve effectiveness, efficiency and co herence related to structures and systems of public health 
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 0 Incoherence and incompleteness would remain as regards the ha ndling 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 monito ring, risk assessment and risk management 
of public health would be inadequately addressed for serious cross-border threats to health other than communicable diseases. 
                                                 
219 Effectiveness= the extent to which optio ns achieve the objectives of the proposal 
220 Efficiency/cost effectiveness = the extent  to which objectives can be achieved for a given level of resources/at least cost (c ost-effectiveness) 
221 Coherence = the extent to which options are coherent with the ov erarching objectives of EU policy, and the extent to which the y are likely to limit trade-offs across the 
economic, social and environmental domain 
 
EN 102   EN communication) 
 
2.2. preparedness and response 
planning, common approach at EU level for all serious cross-border 
threats to health 
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 0 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 comm unicable diseases), chemical or environmental 
events would not be developed. Considerations of the European Parliament
222 and the Council223 for providing better support 
for the Member States in achieving a cohe rent approach to preparedness for and re sponse 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 wil l 
not be ensured.  
c. The questions of core capacity require ments for preparedness and response and EU tailor-made criteria for notification of 
health threats will not be addressed. Parallel and uncoordinate d 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 exp ected in terms of improving access to medi cal 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 du ring the Pandemic H1N1 2009 will not be addressed.  
2.3. risk monitoring and assessment: 
coherent and comprehensive 
approach for 
- identification (detection) and 
notification of health threats, based 
on improved linkage between 0 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 an d 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 author ities. The Commission would also no t be notified of such threats  
through the IHR.  
                                                 
222 European Parliament resolution of 8 March 2011 on evaluation of the management of H1N1 influenza in 2009-2010 in the EU (2010/ 2153(INI)) 
223 Council conclusions of 13 September 2010 on Lessons learned from the A/H1N1 pandemic – Health security in the European Union ( 12665/10) 
 
EN 103   EN 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 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 expe rtise 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 capacitie s 
either in the short-term or long term, and gaps and inconsiste ncies 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. 
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 
stronger commitment of Member States 
 0 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 a nd a strong commitment of Member 
States Considerations of the European Parliament
224 and the Council225 for the possibility of a long-term solution on health 
security, including provision of a legal basis for the Health Security Commi ttee, are not addressed. 
Risk management would continue to be ensured by two ex isting 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 an d public health measures would not be sufficiently coordinated  
under the status quo. 
2.5.crisis communication: improved conditions for crisis communication 0 The impact under this option is low as structures are not strengthened and cond itions 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 co ordination at EU level for cross-border health threats. 
3. Social impacts 0 Under this option no changes are expected related to the employment, labour market and job quality. Under s tatus quo no 
other effects on society, such as impacts on social inclusio n, protection of particular gr oups, equality of treatment and 
opportunities, non-discrimination, social protection an d 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 European Parliament resolution of 8 March 2011 on evaluation of the management of H1N1 influenza in 2009-2010 in the EU (2010/ 2153(INI)) 
225 Council conclusions of 16 December 2008 on health security (16515/08) 
226 Early warning and response network, Decision 2119/98 (OJ L 268 3 10 1998, p.1) 
 
EN 104   EN 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 mi strust 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 acce ss 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 situ ation where, in case of cross-
border health threats, Member Stat es will be pitched against each othe r by the producers for access to medical 
countermeasures. Cooperation with other sectors of society will c ontinue to be done on an ad-hoc basis and therefore this 
option will not strengthen the cooperation in a sustainable and systematic way. 
 
4. Economic impacts 0 Serious cross-border health threats can affect large number of  persons and entire regions and therefore h ave 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 response s in an event of a public hea lth 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 mi ght 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 whole
228.  
In terms of influenza epidemics in indust rialised countries total estimated direct  and indirect costs may reach EUR 56.7 
                                                 
227 See tables 1 and 2 in annex 6  
228 See end note 28 related to table 1 in annex 6  
 
EN 105   EN million per million people229. Therefore, a coordinated approach to mitigat e 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. Th e need for increased preparedness in sectors 
other than health has been identified as an area where pandem ic 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 al one may also significantly damage the interest of other Member States (e.g. 
interruption of trade and critical  services such as transport, IT technologi es, 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 pu blic 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 economy
232.  
Innovation, development and research  in the field of medical countermeasures  (impact on the sector of pharmaceutical 
industry): Under the status quo option capacity building fo r 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 ther efore its implementation depends entirely on  MS and it is the MS responsibility to 
review their vaccination strategi es for seasonal flu. Thus, the impact will de pend on whether MS ar e committed to support 
approaches to increase prod uction capacity generally.  
It should be noted that under option 1 research and developmen t on pharmaceutical products is  generally supported through 
                                                                                                                                                                                                                                                    
229 Explanatory Memorandum to the proposal  for a Council recommendation on seasonal infl uenza vaccination; COM(2009) 353 final/2;  http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0353:FIN:EN:HTML  
230 http://www.who.int/countries/ eth/areas/cds/en/index.html  
231 http://www.who.int/csr/disease/influenza/CP045_ 2009-0808_WOS_Pandemic_Readiness-FINAL.pdf  
232 Stern A; Markel H What Mexico Taught the World About Pandemic Influenza Preparedness and Community Mitigation Strategy, JAMA, September 16, 2009; 302:1221-
1222 
233 http://ec.europa.eu/research/fp7/index_en.cfm?pg=health  
 
EN 106   EN the EU Framework programmes for Research and Development. Howe ver, this allows only for long term solution to increase 
availability of vaccines and medical countermeasures and does no t 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 affect ed 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 co sts for staff, administration such as organisation of 
meetings will stay the same. As option 1 is consistent with th e baseline scenario, i.e. the curr ent situation resources to supp ort 
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 in itiative. 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 fi ve 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 s ituation will persists and certain ly 
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 Commis sion. 
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 co ncerning the use resources between the EWRS network and the Health Security 
Committee related to communicable diseases in the EU. Negative im pacts also relate to the lack  of sustainable capacity to 
address serious cross-border health thr eats 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 th e process of ending expertise at all may 
be time-consuming. 
 
EN 107   EN 7. EU added value 0 The EU added value in handling a serious cross-border health threat will remain unchanged as the current sy stem is not 
strengthened.  
8. Impact at International level 0 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 comba ting the disease on the spot), or in case of contact tracing 
procedures to identify potentially contaminated pe rsons (e.g. multi-drug resi stant Tuberculosis).  
Information available on outbreaks or se rious threats due to communicable diseas es 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 fo rmal nor sustainable. 
Overall, and in particular for other serious cross border thr eats to health, collaboration at international level will not be 
improved. 
 
EN 108   EN Option 2: Separate and different handling of serious cross-border threats to health – enhanced cooperation by using soft instru ments based on 
a voluntary approach 
Assessment Criteria Rating Motivation of the rating and aspe cts of the policy action nece ssary 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 s ituation for preparedness and re sponse 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   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. 
 
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) 
 + Under this option, serious cross-border health threats are still addressed separately (division between the EU legal regime o n 
communicable diseases and the formal Commission framework on other threats). Although othe r threats are dealt within a 
formal structure (Commission expert group), the integrated appr oach 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 respec tive national policies and therefore facilitate the coordination 
of health-related crisis among sectors in Member States. 
2.2. preparedness and response 
planning, common approach at EU 
level for all serious cross-border threats to health + 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 Effectiveness= the extent to which optio ns achieve the objectives of the proposal 
235 Efficiency/cost effectiveness = the extent  to which objectives can be achieved for a given level of resources/at least cost (c ost-effectiveness)  
236 Coherence = the extent to which options are coherent with the ov erarching objectives of EU policy, and the extent to which the y are likely to limit trade-offs across the 
economic, social and environmental domain 
 
EN 109   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 contribu te to guidance and implement it  accordingly on the basis of 
a soft instrument such as a Council R ecommendation, there would be an improvement of preparedness as common indicators 
and arrangements can be put in place, and progress can be monitored and report ed 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, howeve r, 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 IHR
237 would be adapted for EU requirements in order to ensure that all 
serious cross-border health threats would be notified (pleas e refer to the part for Risk monitoring and assessment for 
additional information). 
The impact of this option on access to me dical 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 prot ected or treated within a short time frame 
when a threat emerges. 
In addition, this option foresees the setting up of a compleme ntary EU stockpile which could alleviate urgent/unforeseen 
needs exceeding the capacity of national stockpiles. In the area of communicable di seases, 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 110   EN 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 + 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 rapi d 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 a llow 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 au thorities will be informed earlier wh en alerts are notified through 
other EU alert systems and vice versa, and define at an ear lier stage whether the notified events would constitute a serious 
cross-border threat to health.  
There is also improved impact as notification would be linke d to IHR and EU tailor-made cr iteria for notification will be 
defined at EU level, taking severity into account.  
A positive impact would be that due to arrangements (to be es tablished 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 capac ities in the short and long term and create a basis for solid 
and independent scientific expertise to respon d to serious cross-bord er threat to health. 
2.4. risk management:  improved 
coordination - sustai nable structure at 
EU level for any cross-border public health crisis;  
clear mandate and strong 
commitment of Member States + 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 th e informal Health Security Committee) for all other serious cross-bord er threats to health. 
These redefined structures would be sustainable and improve eff ectiveness 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 111   EN This option would have a more significant impact than the measures under option 1. 
3. Social impacts + Similarly to the status quo option 2 will not have impacts on employment, labour market and job quality.  
Communication:  As described above this option would provide th e 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 cohere nt 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 op tion 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 w ould 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 en tire 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 112   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 threa ts 
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 availa bility of medical countermeasures option 2 is e xpected to be an impr ovement 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 co untermeasures 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 additio nal 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 113   EN financial and contractual conditions will remain much weaker comp ared to the option of a full joint procurement, as proposed 
under Option 3. 
Financial implications of the potential setting up of a compleme ntary EU stockpile of medical countermeasures are illustrated 
in annex 17. Because a complementary EU  stockpile would mean that Member St ates 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 costs
239.  
6. Administrative burden 0 Under this option governance would be improved as mandates of the two relevant committees, namely th e 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 diffe rent 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 repor ting 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 administra tive burden would also be re duced 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.  
78. EU added value + The EU added value would be increased as the coordination of preparedness for and response to a cross-bord er 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, st rengthened links between notification systems of different 
sectors, and improved functioning of the two committees at the EU level would contribute to this objective.  
                                                                                                                                                                                                                                                    
239 http://europa.eu/rapid/pressReleasesAction.do?reference=IP /06/732&format=PDF&aged=1&language=EN&guiLanguage=fr  
240 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 114   EN In addition, as regards medical counterm easures and their procurement in particul ar, the transparency of procedures and 
conditions would improve exchange of best practices of purcha se agreements and therefore he lp Member States across the 
Union.  
80. Impact at International level + Under this option, the impact  related to international level would be stronger than in stat us quo as this option would also 
address the reporting conditions of threats other than communi cable diseases being notified to WHO through the IHR without 
informing the EU. Under this option, notification would be li nked to IHR and EU tailor-made cr iteria for notification will be 
developed at EU level. 
 
EN 115   EN Option 3: Establish common EU legal framework: covering all se rious cross-border threats to health – improved cooperation and l egally 
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 ++ 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). 
2. Public health security structures 
and systems: Effectiveness241, 
efficiency242 and coherence243 as 
regards the objectives described in this initiative ++ Option 3 would be the option that improves most effectivene ss, 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 objec tive to improve availability and access to medical countermeasures  
by the Member States and therefore strengthen the capacity of Me mber States to mitigate the public health impact of a serious 
cross-border health threats. 
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) ++ 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-bord er threats to health, including those notif ied under IHR, would be reported at EU 
level according to the EU tailor-m ade criteria for notification. 
c. Public health risk assessment would cover all serious cross-border threats to health. Existing entities responsible for risk  
                                                 
241 Effectiveness= the extent to which optio ns achieve the objectives of the proposal 
242 Efficiency/cost effectiveness = the extent  to which objectives can be achieved for a given level of resources/at least cost (c ost-effectiveness) 
243 Coherence = the extent to which options are coherent with the ov erarching objectives of EU policy, and the extent to which the y are likely to limit trade-offs across the 
economic, social and environmental domain 
 
EN 116   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" appro ach. There would be no dis tinction 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 t o 
the risk management. 
2.2. preparedness and response 
planning, common approach at EU level for all serious cross-border 
threats to health 
a. generic and specific preparedness 
b. common core capacities for 
preparedness / EU tailor-made criteria for notification (to address 
IHR with a common approach) 
c.- ensuring coherence and 
interoperability among critical 
sectors of society 
d equitable access to medical 
countermeasures +++ a. Under this option preparedness planni ng would be significantly improved and wo uld 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. 
b. General criteria for core capacity for surveillance an d response based on those set out in Annex 1 of the IHR
244 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 positiv e 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 sector s 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 availab ility 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 and comprehensive 
approach for  ++ 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 heal th 
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  
 
EN 117   EN - 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 appropriate because events arising from causes other than communicable diseases are not regular and are less frequent than 
communicable disease events
245.  
Similarly, in the area of risk assessment legal arrangements ar e 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 strength en 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 investme nt 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. 
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 
 ++ The positive impact would be to provide one unique structure wh ere all serious cross-border health crises could be managed 
from the public health perspective. Th is 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 legislativ e acts, joint actions (such as joint procurement of medical 
countermeasures) and voluntary mutual ag reements 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 See annex 11 
 
EN 118   EN 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 im proved under this option as notification systems will be linked 
better and structures for risk assessment and management in th e 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 threat s, 
thus providing improved means for inter-sectoral cooperation. 
Solidarity and equitable acce ss 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. 
 
EN 119   EN 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, as sessment and management of the Health Security Initiative 
Member States:  
• Notification costs are not expect ed 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 procedur es 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 cost s 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 buildin g 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 fina ncial resources from the EU health programme (500.000 - 
1 Mio € per year in addition) to set up framework contracts in order cove r existing gaps by making expertise 
 
EN 120   EN available where needed. 
The calculation is based on experience with a similar pilo t 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 relate d to toxic chemicals (94 poison centres in the EU). 
Cross border threats caused by chemical, biological and envi ronmental events do not occu r as often as communicable 
diseases. Based on IHR notifications we can expect on average 5-6 such events per year
246. Under EU tailor made criteria 
for these incidents the threats notified - ba sed on experience with alerts for comm unicable 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 an d 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 thes e 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 th eir own initiative; however, 
                                                 
246 See information in annex 11 
 
EN 121   EN there is no possibility and no intention to im pose measures with financial implications.  
2. Access to medical countermeasures: 
 
With regard to access to medical countermeasures option 3 w ould 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 m echanism such as that already employed by the Pan American Health Organization 
would allow for benefits and generate sa vings resulting from stronger purchasing po wer, 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 agreemen ts 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 countermeas ure 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 ov er-capacity can be avoided. 
- the security of having advance purcha se agreements, even if at less favourab le 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 purc hase agreements allows the supp lier 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 th rough 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 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. 
 
EN 122   EN - 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 setti ng 
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 150,00 0 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 
 
EN 123   EN reporting can be expected. 
In addition, Member States would need to dedicate staff capacitie s 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 effort s 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 th ese instruments are already in place, th e additional investment for which human 
resources are needed can be considered marginal. This add itional 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 administrati ve burden for the en tity 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 h ealth threat. In the 
case of an outbreak or a public health event which would re quire the activation of the cont ract, the administrative needs 
would rise steeply: However, for the participating countries th e 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 administrativ e burden is expected 
 
EN 124   EN 7. EU added value ++ Under option 3 EU added value would be increased throughout all elements of preparedness and response plan ning, 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. 
In providing also a legal basis for operating a joint procur ement mechanism for medical countermeasures it would add value 
to strengthening preparedness and response capacity to cross-border health threats across the EU. 
8.. 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 emer gencies 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 ma nagement 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 w ith third countries and other 
international partners and organisations. 
 
EN 125   EN Annex 20: Comparison of the policy options 
Rating:   
0 Baseline scenario, neutral impact 
+ positive impact; ++ significant positive impact,  - negative impact; -- significant negative impact, 
Assessment Criteria Option 1 
Status quo  Option 2 
improved 
cooperation by 
use of soft instruments- 
voluntary 
approach Option 3 
Improved 
cooperation; 
legally binding 
measures 
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  0 + ++ 
2.2. Improved preparedness and response planning, 
common approach at EU level for all serious cross-
border threats to health 0 + ++ 
2.3. Improved risk monitoring and assessment  0 + ++ 
2.4. Improved coordination and risk management  0 + ++ 
2.5. Improved crisis communication 0 + ++ 
3. Social impacts 0 + ++ 
4. Economic impacts 0 + ++ 
5. Financial implications 0 - - 
6. Administrative burden 0 0 - 
7. EU added value 0 + ++ 
8. Impact at international level 0 + ++ 
Total 0 9 18 
 
EN 126   EN Annex 21: Monitoring the implem entation 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 ev aluation four years after 
implementation of the legal basis 
2. Public health security  structures and systems: 
Effectiveness248, efficiency249 and coherence250 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 risk communication) Legal proposal for Health Security Initiative adopted Regul ar evaluations as legal requirement (article in the 
legislative text), first evaluation after four years of 
implementation of the legal base 
2.2. preparedness and response planning , common 
approach at EU level for all serious cross-bo rder threats to 
health 
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) a. number of new preparedness plans established at EU and 
national level 
further developed generic preparedness principles (possible 
detailed provisions for specific threats)   
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 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 Co mmission every two years with 
a qualitative evaluation of the implementation by the 
Member States 
                                                 
248 Effectiveness = the extent to which optio ns achieve the objectives of the proposal 
249 Efficiency/cost effectiveness = the extent  to which objectives can be achieved for a given level of resources/at least cost (c ost-effectiveness) 
250 Coherence = the extent to which options are coherent with the overarching objectives of EU policy, and the extent to which the y are likely to limit trade-offs across the 
economic, social and environmental domain 
 
EN 127   EN d. equitable access to medical countermeasures participating, amount of medical counter-measures 
purchased through this mechanism 
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  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 pl ace 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 stru cture with strong commitment 
of Member States Sustainable mechanism (operational EU health group) and 
structure in place for EU wide crisis management  
Standard Operation procedures for crisis management 
agreed with Member States 
internal rules of procedures established for a unique 
structure (level of participa tion of Member States, number 
and quality of recommendations issued) Report from the Commission 
2.5.crisis communication: improved conditions for crisis 
communication Agreement on reinforced opera ting procedures for risk and 
crisis communication (who, why,  when, where, how, what) 
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; Communication strategies and coordination of messages 
put in practice 
 
EN 128   EN Annex 22. Glossary: Public Health S ecurity 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 inves tigation, (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 charac teristics 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 defini tions 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 cas e 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 dynami c nature of outbreak investigations. 
Core capacity 
requirements  Core capacity requirements refer a co re set of capacities, structures, 
mechanisms, processes and procedures which need to be in place and available for preparedness and re sponse to addre ss serious cross-
border health threats in the EU. 
Crisis 
management Management of any critical situat ion that causes a disruption to the 
balance between the demand for and s upply of medical services. Crisis 
management involves the plans,  structures and arrangements 
established to bring together th e normal endeavors of government, 
voluntary and private agencies in a comprehensive and coordinated 
way to deal with the whole spectr um 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, safet y, health, security or 
 
EN 129   EN 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 risk assessment process includes the 
detection/alerting and monitoring/surv eillance of emerging threats, the 
evaluation of potential risks to p ublic health coming from those 
threats, as well as the notification of  such risks to concerned entities. 
Risk management covers the sum of the decisions and actions taken by 
competent authorities during and after a crisis. Risk management 
includes the whole spectrum of  emergency needs including 
prevention, response and recovery. These, for example cover the 
diagnosis of cases by sp ecialised laboratories, providing medical care 
if necessary even in mo bile units, vaccination, containment of people, 
travel advice, rules on persona l protection and hygiene, or 
decontamination measures. Efficient communication has become an 
important part of risk management. 
Crisis 
preparedness and 
response 
planning Developing and strengthening capaci ties to respond rapidly to any 
kind of emergencies affecting or likely to affect public health. 
 
Crisis 
preparedness 
plan A written document or map for public health crisis management 
published by the responsible authority. The organisation, 
responsibilities and measures are de fined - with details on how, when 
and whom - both before and afte r an event with  public health 
consequences occurs. It aims to provide a policy for preparedness and 
response to both internal and extern al disaster situations that may 
affect the population and the community. 
Preparedness is the knowledge and capacities developed by 
government, organisations and commun ities to effectively anticipate, 
respond to, and recover from, the im pacts of a likely, imminent or 
current crisis. 
Critical infrastructures Critical infrastructures are those ph ysical and information technology 
facilities, networks, services an d assets which, if disrupted or 
destroyed, would have a serious imp act 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 severa l sectors at the same time. 
 
EN 130   EN Health 
measure Procedures applied to prevent the sp read of disease or contamination; 
a health measure does not include law enforcement or security measures. 
Health security Activities required, both  proactive and reactive, to minimise 
vulnerability to acute public health events that endanger the collective health of populations  living across geographical regions and 
international boundaries. 
IHR (2005) International Health Regula tions - IHR ( 2005): the WHO 
international regime providing glob al rules to enhance national, 
regional and global pub lic health security. This legally-binding 
agreement significantly contributes to  global public health security by 
providing a new framework for c oordinating 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 hea lth threats (www.who.int/ihr/en/ ). 
IHR (2005) 
Annex 2 The annex 2 of the IHR (2005) is a decision instrument for the 
assessment and notification of even ts 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 authoritie s joining their public procurement 
actions. 
Quarantine Restriction of activities and/ or separation from others of suspect 
persons who are not ill or of susp ect 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, st ainless steel contaminated with 
cobalt-60. 
Response Sum of public health decisions and measures taken during and after a 
disaster, including immediate relief, rehabilitation and reconstruction. 
Risk 
assessment A scientifically based process consisting of the following steps: (i) 
threat detection and iden tification, (ii) threat  characterisation, (iii) 
exposure assessment, and (i v) risk characterisation. 
Risk 
communication The exchange and dissemination of appropriate information about 
risks to enable decision makers, st akeholders and the public to make 
appropriate decisions. 
Risk A process, distinct from risk assessment, of weighing policy 
 
EN 131   EN management alternatives, in consultation with interested parties, considering risk 
assessment and other factors rele vant for health protection of 
consumers, and if needed selecti ng appropriate prev ention and control 
options. 
Serious cross-
border public 
health threat An event of biological, chemical , radiological and nuclear or 
environmental origin or caused by climate change, with potentially 
severe consequences for public hea lth which affects or could affect 
more than one Member State in su ch 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. 
Stockpile of 
medical 
countermeasures A supply of medical countermeasures stored for future use against a 
health threat. 
 
 
EN 132   EN 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 Mi nisters and the European Commissioner for Health and 
Consumer Protection 2384th Council meeting  
http://www.consilium.europa.eu/uedocs/cm s_data/docs/pressdata/en/lsa/DOC.68699.htm  
http://europa.eu/rapid/pressReleasesActi on.do?reference=PRES/01/415&format=HTML&age
d=0&lg=nl&guiLanguage=en  
What is the Health Security Committee? - Wh at is the Early Warning and Response System 
(EWRS)? MEMO/09/363  
http://europa.eu/rapid/pressReleasesAc tion.do?reference=MEM O/09/363&type=HTML  
Council conclusions of 5 February 2007  on the Communication from  the Commission to the 
Council on the transitional prolongation and extens ion 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 HS C was temporarily prolonged covering also 
pandemic influenza and generic preparedness an d response planning and the general revision 
of the structures dealing with h ealth 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 ba sis 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.eur opa.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/preparedne ss_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 Un ion on preparedness and response to biological 
and chemical agent attacks (Health Security) COM(2003) 320 final  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.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 prepar edness planning for public 
health emergencies at EU level COM(2005) 605 final  
http://eur-lex.europa.eu/LexUri Serv/site/en/com/2005/com2005_0605en01.pdf  
Commission Staff Work ing 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 publishe d a Commission Staff Working Document  SEC(2009) 
1622 final  
http://ec.europa.eu/health/pre paredness_response/docs/comm ission_staff_healthsecurity_en.p
df 
 
EN 133   EN Commission Staff Work ing 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 Counc il, in its conclusions adopt ed on 13 September 2010 on 
lessons learned from the A/H1N1 pandemic - h ealth security in the European Union. The 
principles for the initiative were set out in the Commission Sta ff Working Document 
SEC(2010) 1440 final  
http://ec.europa.eu/health/p reparedness_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 epidemiologica l surveillance and control of communicable 
diseases in the Community http://eur-lex.europa.eu/LexUriServ/L exUriServ.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 cont rol of communicable diseases under Decision 
2119/98/EC of the European Pa rliament 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/LexUri Serv.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 fo r disease prevention and control 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.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 Preparedne ss and Response Planning in the European 
Community COM(2005) 607 final  
http://eur-lex.europa.eu/LexUri Serv/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_thr eats/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/L exUriServ.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/L exUriServ.do?uri=SEC:2009:1189:FIN:EN:PDF  
Commission Staff Work ing 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/L exUriServ.do?uri=SEC:2009:1190:FIN:EN:PDF  
Commission Staff Work ing Document of 15 September 2009  on Regulatory process for the 
authorisation of antiviral medicines and vaccine s in the protection against Pandemic Influenza 
(H1N1) 2009 SEC(2009) 1191 final   
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=SEC:2009:1191:FIN:EN:PDF  
Commission Staff Work ing Document of 15 September 2009  on Support to thir d countries to 
fight the Influenza A(H1N1) SEC(2009) 1192 final   
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=SEC:2009:1192:FIN:EN:PDF  
International Health Regulations (IHR)  
 
EN 134   EN Communication of 26 September 2006  from the Commission to the European Parliament and 
the Council on the Internati onal Health Regulations COM(2006) 552 final  
http://ec.europa.eu/health/ph_int ernational/documents/comm_ihr_552_2006_en.pdf  
International Health Regula tions (2005), Second edition, Authors : World Health 
Organization (WHO), Public ation 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 Eu ropean Parliament and the 
Council on Strengthening Chemi cal, Biological, Radiological a nd Nuclear Security in the 
European Union – an EU CBRN Action Plan COM(2009) 273 final  
http://ec.europa.eu/home-affa irs/summary/docs/com_2009_0273_en.pdf  
Accompanied by SEC(2009) 790 / 791 / 874 Commission Staff Work ing 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/L exUriServ.do?uri=SEC:2009:0790:FIN:EN:PDF
 
Commission Staff Work ing 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/L exUriServ.do?uri=SEC:2009:0791:FIN:EN:PDF  
Council conclusions on strengthening chemical, biological, radiological  and nuclear (CBRN) 
security in the European Uni on – 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/L exUriServ.do?uri=COM:2009:0147:FIN:EN:PDF  
Commission Staff Work ing Document of 1 April 2009 , accompanying document to the 
WHITE PAPER "Adapting to climate change: To wards a European framework for action", on 
Human, Animal and Plant Health Impacts of Climate Change SEC(2009) 416  
http://ec.europa.eu/health/ph_t hreats/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 c o 
2. Structures for preparedness and respo nse to cross-border health threats 
Appendix 
3_Structures for pre p