EUROPEAN COMMISSION 
Brussels, 8.12.2011 
SEC(2011) 1520 final 
  
COMMISSION STAFF WORKING PAPER 
EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 
Accompanying the document 
Decision of the European Parliament and of the Council 
on serious cross-border threats to health 
{COM(2011) 866 final} 
{SEC(2011) 1519 final}  
 
EN 2   EN 1. THE HEALTH SECURITY INITIATIVE  
The aim of the Health Security Initiative is to streamline and strengthen health security 
capacities and structures in orde r more effectively to protect the citizens of the European 
Union (EU) against serious cross-border threats that can affect public health. 
The EU has a well established policy and legal framework to address communicable diseases 
that has been in place since 1998. It sets out legal requirements for the surveillance of 
communicable diseases, the notification of acut e events at EU level through a secure Early 
Warning and Response System (EWRS) and the exchange of information on public health 
measures taken to control such outbreaks. Member States are therefore under the obligation to notify outbreaks of communicable diseases. Inform ation on such diseases is shared in real 
time with all Member States, and measures to ad dress them are coordinated at EU level. Since 
2005, the European Centre for Disease Preventi on and Control (ECDC) provides scientific 
risk assessment on communicable diseases. 
However, not all serious cross-border threats to health are handled in such a consistent 
manner at EU level. The Health Security Initia tive therefore aims to provide a comparable 
level of protection against othe r types of serious cross-borde r threats to health caused by 
biological, chemical and environmental events. The specific nature of these threats will be 
taken into consideration. 
The Health Security Initiative will also help implement the European Health Strategy and 
contribute to the objectives of Europe 2020 by prom oting health as an integral part of the 
smart and inclusive growth objectives. In addi tion, it will contribute to  the overall European 
security effort and in particular help achieve  the agenda set out in the Internal Security 
Strategy. The initiative will also be instrume ntal in strengthening chemical, biological, 
radiological and nuclear (CBRN) security in th e EU as set out in the CBRN action plan and 
stepping up cooperation with the Monitori ng and Information Centre mechanism in 
preparedness for and response to civil disasters . 
The Health Security Initiative will appropria tely take into account the 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 significan t health component
1.  
In the context of this initiative, serious cross- border threats to health  are events caused by 
communicable diseases, or by biological agen ts causing non-communicable diseases, of 
chemical, environmental or unknown origin, or caused by climate change, with potentially 
severe consequences for public health. For the purposes of the initiative, threats emerging 
from the effects of climate change will be co vered by environmental threats. Radiological 
events are excluded from the initiative as they  are dealt with under the provisions of the 
Euratom Treaty. 
                                                 
1 E.g. in 2010 under the “Instrument for Stability” th e EU started a project that  will allow third countries 
to collaborate in numerous regions of the world to build capacities for mitigating risks from chemical, biological, radiological and nuclear materials, irrespective of the origin of the risk (natural, criminal, 
industrial accident). Possible synerg ies will be explored under the Heal th Security Initia tive with this 
initiative to create regional CBRN Centres of Excellence.  
 
EN 3   EN The scope of the initiative w ill cover the EU-level coordinati on of preparedness and response 
planning for these threats to health, includi ng the procurement of medical countermeasures, 
monitoring and assessmen t of the risks to public  health arising from these potential threats 
and management and communication of the id entified risks and health-related crises. 
The initiative was developed following an exte nsive consultation process including an open 
stakeholder consultation on health security in the European Union, seve ral meetings with the 
Early Warning and Response System (EWRS) network and the Health  Security Committee 
(HSC)2, bilateral meetings with six Member States and a presentation to the EU Health Policy 
Forum. The outcome of the open consultation process on ‘strengthening European Union 
preparedness on pandemic influenza’ from  2010 was also taken on board. Relevant 
Commission departments have be en involved in developing th e initiative, including the 
Secretariat-General. 
2. PROBLEM DEFINITION  
2.1. Insufficient and inconsistent prepare dness and response planning among EU 
Member States for all types of se rious cross-border health threats 
Member States are differently equipped to resp ond to serious cross-borde r health threats with 
regard to laboratory infrastructu re, analytical tools or  staff levels, for instance. Moreover, not 
all the critical sectors in society are thoroughly pr epared for a wide rang e of events that may 
have an impact on public health. Member States a nd critical sectors that are less well prepared 
will weaken and delay the EU response and adversely impact on the situation in other Member States. 
In the event of an emergency, a wide range of  public health measures may be necessary, for 
example the diagnosis of cases by specialised labor atories, the provision of medical care, 
vaccination or treatment, travel advice, ru les on personal protection and hygiene, or 
decontamination measures. Apart from health, ot her critical sectors need to be prepared. 
Hospitals, for example, cannot function properly if electricity fails or if  doctors are unable to 
travel to work due to the breakdown of public transport. On the other hand, essential public 
services such as water or energy supply may not  work because a large number of staff fall 
sick. 
Discrepancies in the level of preparedness planning across the EU may lead to incoherent 
strategies, divergent standards, and inconsiste nt procedures and met hodologies. They may, for 
example, entail unequal access to treatment and medical care, endanger management of 
outbreaks, and even lead to an increase in the number of peop le falling sick or dying. Without 
coordination at EU level, Member States may adopt different mutually counterproductive 
measures e.g. as regards closing borders, impos ing quarantine or issuing travel advice, and 
public health measures will be managed on an ad  hoc basis by individual Member States. Risk 
management at EU level will be less effective and public trust in national authorities and in 
EU institutions will be undermine d. Ultimately this may lead to major repercussions on other 
EU policies, not least the func tioning of the internal market. 
Individual procurement of medical counter measures may increase competition between 
Member States. Confidentiality clauses in contracts may considerably weaken Member 
                                                
 
2 The name of this body might be changed in the legal proposal.  
 
EN 4   EN States’ purchasing power and, when combined w ith restrictions on h ealth budgets, may lead 
to procuring insufficient amounts of medical  countermeasures, thereby considerably 
weakening EU preparedness. 
2.2. Gaps and inconsistencies in mechanisms for public health ri sk monitoring and 
risk assessment of biological (other than communicable diseases), chemical and environmental threats 
Although there are a variety of moni toring and alert systems for di fferent threats at EU level, 
these are not systematically linked to EU public health institutions. 
The International Health Regulations (IHR) — an  international treaty for the coordination of 
all health emergencies — stipulate that Member States must notify the World Health Organisation (WHO) about any event that may constitute a public health emergency of international concern, independently  of its origin (biological, chemical, radiological, nuclear 
or environmental). 
There are no similar notification obligations at EU level. What is more, the criteria for such 
notifications are not necessarily appropriate for the EU level, given the existence of a common external border, freedom of movement  and common policies, which necessitate a 
more sensitive system. 
National public health risk assessments exist,  but may not be comprehensive and consistent 
when considered from the EU perspective,  and there is currently no mechanism for a 
coordinated approach at EU  level. The lack of public health risk assessment at  EU level leads 
to discrepancies in evaluating the danger of  a given threat, duplication of assessments 
between Member States and incoherent measures at EU level. Such a situation can also lead 
to inefficient use of the limited resources curre ntly available and may delay appropriate public 
health measures, thereby potentia lly putting at risk the overall response at EU level. The 
adverse impact of this situation might result in  higher levels of morbidity and mortality. It 
may also endanger shared EU policies because of th e impact of health eff ects on other critical 
sectors of the economy and society. Importantly, th e absence of comprehensive or proper risk 
evaluation may lead to unclear communica tion and may undermine public confidence in 
measures proposed or taken by public h ealth authorities in Member States. 
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 
Serious cross-border health thre ats are unavoidable. They do not  happen as frequently as 
communicable diseases, but they can have huge consequences both for health and for other 
sectors of the society and ec onomy. The basis for coordinating the public health response at 
EU level is weak compared with the potential  impacts. The structures  and mechanisms for 
public health risk management at EU level ar e not tailored to the new international legal 
framework (the International He alth Regulations) and are inade quate to deal with a health-
related crisis. 
In addition, the respective mandates, respons ibilities and scope for taking decisions on the 
public health response are not clearly differen tiated between the two existing bodies, namely 
the Early Warning and Response System (E WRS) network and the Health Security 
Committee (HSC). This informal committee was set up by the EU health ministers in 2001 in 
 
EN 5   EN the aftermath of the terrorist attacks, as a structure for better coordinating public health risk 
assessment and management of serious cross- border health threats in the EU. At the 
beginning, its mandate was limited to tackling biot errorism; it was subsequently extended to 
cover all types of public health -related crisis and further pr olonged. It is composed of 
representatives of hea lth authorities of the Member Stat es and chaired by the Commission. 
Given the informal nature of  the Committee and its ad hoc mandate, there is insufficient 
coordination of the public health response and no cross-sectoral inte rlinking of decision 
making processes in public health. Even  shared statements on minimum common 
denominators are difficult to achie ve without a robust framework, le ading to the risk of delays 
in the response to health emergencies. Although a Communicators’ network has been 
established under the Health Security Committ ee, the lack of a formal mechanism for 
agreeing consistent messages to  the public and targ et populations is not conducive to an 
efficient information process at EU level. This undermines the confidence in and credibility of 
the public health response to chemical, biological (o ther than communicable diseases) and 
environmental threats. 
3. THE RIGHT OF THE UNION TO ACT  
With the entry into force of the Lisbon Trea ty, the EU has been empowered to support, 
coordinate or supplement the action of Member  States in the area of the protection and 
improvement of human health (Article 6(a) TFEU ). The Treaty states that EU action must be 
directed towards improving public health, pr eventing physical and mental illness and 
diseases, and obviating sources of danger to phys ical and mental healt h, and in particular 
‘monitoring, early warning of a nd combating serious cross-border threats to health’ (Article 
168 TFEU). 
‘Serious cross-border threats to health’ as defined in the Treaty and ‘public health 
emergencies of international co ncern’ as defined unde r the International Health Regulations 
have, by their nature, transnational implicatio ns which Member States  cannot satisfactorily 
address individually. They often affect crucia l sectors of the economy and society. Many of 
these sectors fall under exclusive or shared EU competence, and therefore require the 
involvement of different stakeholders. 
The EU already has good experience of coordi nation in the field of communicable diseases, 
which is governed by a comprehensive body of  EU legislation and ha s proved essential in 
handling serious outbreaks in Europe. The Health Security Initiative will build on this positive 
experience, as well as on the existing instrume nts and lessons learnt. Because not all Member 
States have the same level of preparedness, ri sk assessment and crisis management, the Health 
Security Initiative will improve the coordinatio n of the management of serious cross-border 
health threats at all levels. Member States’ preparedness will  be strengthened by establishing 
common procedures and standards, sharing resources, and improving the exchange of 
expertise and information. Capacities for rapid a nd efficient response will be reinforced, and 
effective coordination of the ma nagement of serious cross-bor der health threats will be 
ensured. Access to and availability of medi cal countermeasures will be better balanced 
between Member States. Strengthened coordinati on at EU level will lead to a coherent and 
comprehensive approach to risk assessment and management. This initia tive will also provide 
the EU Member States with an opportunity to  coordinate their action in implementing the 
International Health Regulations. 
 
EN 6   EN 4. POLICY OBJECTIVES  
Given the problems identified in Section 2, the health security initiative aims to achieve the 
objectives set out in the table below. 
 
EN 7   EN Table 1: Objectives of the Health Security Initiative 
General objectives 
More effectively protect the citizens of the European Union against seriou s cross-border threats to he alth and ensure a high le vel of human health protection in framing and 
implementing EU policies and activities 
Specific objectives 
Reinforce the response to all serious cross-border threats to health based on a comprehensive and coherent approach to preparedness and response planning, ri sk monitoring and 
assessment, and risk management, including risk communication 
Preparedness and response planning Risk monitoring and assessment Risk management and crisis communication 
Develop a common approach to preparedness planning at EU level for all serious cross-border thr eats to health, ensuring 
coherence and interoperability among sectors at EU level and 
among Member States, including improving equitable access to 
medical countermeasures Create the necessary conditions to ensure the coherent 
and comprehensive identification and notification of 
health threats and the eval uation of their risks to 
health, especially in the cas e of health-related crises 
with a multidisciplinary dimension - Create the necessary conditions to strengthen and 
enhance coordination among Member States, 
international bodies and the Commission in order to 
ensure a coherent and consistent policy approach to 
effectively manage responses  to serious cross-border 
health threats across the EU 
- 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  
- Develop and update comparable and coherent generic 
preparedness and response planning, and planning for specific 
threats at EU level, in particular for pandemic influenza 
- Develop and agree shared standards and tailor-made EU 
criteria for notifying threats in order to ensure stronger, 
continued and resilient operation of the public health sector in 
the European Union based on the requirements laid down by the International Health Regulations 
- Create an instrument to impr ove equitable access to medical 
countermeasures, e.g. through a joint procurement mechanism - Strengthen, better interlink and ensure the 
sustainability of existing monitoring and notification 
mechanisms and structures 
- Strengthen and create capacities for public health 
risk assessment that is robust, reliable, compatible 
between sectors, and rapidly available  
- Provide mechanisms for reinforced coordination 
among existing structures for serious cross-border 
health threats other than communicable diseases - Strengthen the capacities and processes and establish a 
sustainable structure/body for coordinating the public 
health response at EU level to any cross-border public 
health crisis 
- Clearly define the scope of the activities of this 
structure/body and give it a strong mandate for EU risk 
management, with a strong commitment from Member States 
- Strengthen measures related to risk and crisis 
communication on health thr eats, and provide for rapid 
exchange and agreement on communication messages 
and strategies 
 
EN 8   EN 5. POLICY OPTIONS  
In order to cover all asp ects of crisis management in a coherent framework , each of the 
options presented includes solu tions for preparedness and res ponse planning, risk monitoring, 
assessment and management. 
The measures identified in each option vary according to the level of implementation of 
preparedness planning and core capacity requirements and the le vel of obligation on Member 
States in terms of implementation, the informal or  formal nature of the expertise provided for 
risk assessment, and the power  conferred on the EU with re gard to risk management: 
• Option 1 (the status quo) envisages no additional action and corresponds to the 
baseline scenario. 
• Option 2 comprises additional action based on so ft instruments, in particular Council 
recommendations, to ensure the involvement of the Member States and closer 
cooperation between existing structures a nd systems. There are no legally binding 
measures under this option. 
• Option 3 proposes a legal framework that lays down binding measures for Member 
States as regards preparedness planni ng, provides a legal basis for voluntary 
measures and implements a robust structur e for crisis management. This option seeks 
to amend the existing Council and Europ ean Parliament Decision on communicable 
diseases and extend it to serious cross-border  health threats cau sed by biological 
(other than communicable diseases), chemical or environmental events. The 
provisions for risk assessment under this  option are not incl uded in the legal 
framework as they also build on closer cooperation between existing structures and 
systems and are intended to cove r existing gaps in these areas. 
A summary of the measures related to the three options is attached in Table 3 in the Annex. 
6. ANALYSIS OF THE IMPACTS  
6.1. Option 1: Status quo/baseline scenario — maintain the current level of activities 
Under this option the current si tuation including the problems described in Section 2 would 
remain unchanged. 
6.2. Option 2: Separate and different handlin g of serious cross-border threats to 
health — enhanced EU cooperation thro ugh the use of soft instruments based 
on a voluntary approach — no legally binding measures 
Public health impact . The impact on public health would be improved as the overall situation 
in terms of preparedness for a nd response to a crisis  would be strengthen ed along with the 
effectiveness, efficiency and coherence of public health security structures and mechanisms. This would be achieved through EU-wide re commendations supported by Member States. 
However, these positive impacts would rely on the commitment of the Member States to agree on these recommendations and implement them on a non-binding basis. To a certain 
extent, this option could lead to increased coherence of overall preparedness, improved 
 
EN 9   EN coordination of existing notification tools and strengthened risk assessment capacities. The 
risk management structures supporting the coordinated response at  EU level would be 
sustainable with clearer mandates, thereby imp roving the effectiveness of health crisis 
management, including communication. Regarding equitable access to medical 
countermeasures, the impact of this option is expected to be an improvement on individual 
national procurement procedures. However, the proposed activities would remain at the level 
of cooperation between individua l authorities in charge of procurements, and purchasing 
power and the ability to obtai n better contractual conditions would remain weak at best. 
Social impact . Provided that the Member States implement the agreed guidance and 
recommendations, improved risk management and in  particular better c oordination of risk 
communication would have a beneficial effect on citizens as messages issued to the public 
would be more consistent with in the EU, thereby boosting confid ence in the ability of public 
health authorities to manage a health crisis. Inter-sectoral  cooperation to improve public 
health protection would be strengthened. As regards equitable access to medical 
countermeasures, this option would enable expe rtise to be pooled among the Member States 
and solidarity to be improved in terms of preparation of the procurement procedures. 
Economic impact . Option 2 could lead to more rapid risk assessment and management of a 
given threat. These improved structures and syst ems at EU level would result in strengthened 
capacities to contain and mitigate a serious cross- border health threat and its related economic 
consequences. As a result, the disruption of the internal market and ex ternal trade functions 
might be minimised and economic losses reduc ed. However, these potential impacts would 
rely essentially on the commitment of the Me mber States. Option 2 could positively impact 
on innovation and R&D efforts related to the de velopment of such products. However, this 
would not ensure improved access to medical countermeasures. 
Financial implications . No additional costs would arise for Member States and stakeholders, 
because the financial situation would be  the same as described in option 1. 
Administrative burden . Under this option, the administra tive burden for the Member States 
and the Commission would be reduced as the ma ndates of the two relevant committees — the 
Early Warning and Response System Network and the Health Security Committee — would 
be clearly defined, thereby limiting the risk s of overlap. As regards access to medical 
countermeasures, the administrative burden coul d also be reduced for Member States, as 
national expertise would be pooled. 
EU added value . The EU added value would be increase d as the coordinati on of preparedness 
for and response to cross-border health th reats would be enhanced at EU level. 
6.3. Option 3: Establish a common EU legal framework covering all serious cross-
border health threats by extending exis ting legislation — improved cooperation 
and legally binding measures 
Public health impact . Under this option, the protection of  EU citizens against serious cross-
border health threats and the effectiveness of public health  security structures and 
mechanisms at EU level would be considerably improved. This would allow coherent preparedness planning based on shared an d common mandatory st andards and a better 
coordinated and balanced response to all types of serious cross-border  health threats. For 
example, all Member States would need to have  preparedness plans in  place that would cover 
both health measures and other critical sectors, and structures and capacities would need to be 
 
EN 10   EN set up in compliance with agreed check lists. This  option would also result in a more coherent 
and comprehensive approach to  the identification, notification and assessment of serious 
cross-border health threats. By setting up a le gal basis allowing joint procurement, this option 
would considerably improve equitable access to  medical countermeasures by Member States, 
thereby ensuring a higher level of protection of EU citizens across the Union. Furthermore, 
inter-sectoral cooperation would be improved in the event of cross- border health threats, also 
contributing to better public health protection. 
Social impact . Along with the impacts related to improved coordination of communication 
already identified for option 2, a coordinated approach to acce ss to medical countermeasures 
would raise confidence in measures undertaken by public health authorities, as they would 
rely on a robust legal instrument. For those Memb er States that had opted to participate in 
joint procurement, the mechanism would lead to  a higher level of protection for vulnerable 
groups by ensuring a guaranteed supply and woul d promote solidarity between the Member 
States by providing common minimum covera ge for vulnerable groups of society. 
Economic impact . The positive impacts already described under option 2 could increase, 
because the planned measures under option 3 would be based on binding agreements. The 
setting-up of a joint procurement mechanism for medical countermeasures would boost the 
supply of medical products and encourage development of new products based on long-term 
contracts agreed with the public health sector. 
Financial impact . As regards preparedness, additional cost s could be expected , particularly in 
relation to human resources and the provision of tech nical equipment in the Member States 
and at EU level. In order to cover gaps in risk  assessment, additional financial resources in the 
region of EUR  500  000 annually would be needed from the EU health programme to establish 
a framework contract so as to gain access to  expert knowledge when needed. The aim would 
be to establish permanent networks of nationa l correspondents between he alth authorities and 
agencies competent in assessi ng specific threats. However, proposed measures relating to 
enhanced cooperation would have no substantial financial impacts, because they would be 
based on the existing mechanisms and structures in place. 
Administrative burden . Governance in public health risk  management woul d be significantly 
improved, as only one expert committ ee would need to be operated. 
EU added value . Under option 3, the EU added value woul d be increased across all aspects of 
preparedness and response planning, risk assessment and risk management by setting up 
strategic and technical cooperation on health security at EU  level. This would be guaranteed 
by the establishment of a robust legal instrument for all serious cross-borde r health threats. By 
also providing a legal basis for operating a joint procurement mechanism for medical 
countermeasures this option could add valu e to strengthening prep aredness and response 
capacity to deal with cross-borde r health threats across the EU. 
Impact at international level . Better coordination in the EU of IHR implementation by the 
Member States and closer collaboration be tween the EU and WHO on preparedness for and 
response to public health emergencies of intern ational concern would c ontribute to enhancing 
global health security. 
 
EN 11   EN 7. COMPARING THE IMPACTS  
Table 2: Comparison of the policy options 
Rating:  0 Baseline scenario, neutral 
+ positive impact ++ significant positive impact  - negative impact -- significant negative impact  
Assessment criteria Option 1 Option 2 Option 3 
1 Improved protection of EU citizens against serious cross-border 
threats to health 0 + ++ 
2. Improved public health secu rity 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 
This comparison focuses on options 2 and 3, wh ere new impacts can be expected. There are a 
number of differences between  options 2 and 3 which dem onstrate 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 de pends on a volun tary approach 
the positive impacts would not be  guaranteed as they would rely only on the commitment of 
the Member States. In comparison, option 3 al so establishes common mandatory standards 
that would lead to considerably improved c oordination at EU level.  Both options also 
strengthen risk notification and assessment . However, option 3 would provide for a more 
coherent and comprehensive approach as a coor dination system would be put in place. Risk 
assessment capacities would be improved by filli ng gaps in current risk assessment capacities 
under option 3. For risk and crisis management , option 2 would improve the overall situation 
as the mandates of the two co mmittees would be clarified. However, option 3 would merge 
 
EN 12   EN the two committees, providing a sound basis for cr isis management of a ll serious cross-border 
health threats. Risk and crisis communication  would be also be improved under both options, 
but under option 3 the linking of communicators and crisis managers would ensure that 
communication strategies could be developed w ithin the overall approach of response to 
public health events. 
8. CONCLUSIONS AND PROPOSAL FOR IMPLEMENTATION  
Option 3 has the strongest health impacts as  it provides improved protection of citizens 
against serious cross-borde r health threats. It proposes a comprehensive framework for health 
security structures and systems including obligations on Member States in terms of preparedness and response planning. It make s notifications at EU level mandatory and 
establishes a clear mechanism to address all ty pes of public health event by merging the two 
existing committees. 
Option 3 also offers the best po ssible EU added value and best fulfils the funda mental goal of 
the Lisbon Treaty of ensuring a high level of human health protectio n against all serious 
cross-border health threats. 
The legal form under this option would be a legislativ e act of the European  Union adopted by 
ordinary legislative procedure th at would repeal but take over th e provisions of the current EP 
and Council Decision of 1998 on communicable dis eases and extend them to health threats 
caused by biological, chemical and environmental events. 
9. M
ONITORING AND EVALUATION  
Systematic follow-up of the policy measures in the field of preparedness and response 
planning, risk assessment and risk manage ment will be ensured by evaluating the 
implementation of the legislative instrument. 
The Commission will submit to the European Parliament and the Council regular reports 
evaluating the implementation of the legal act.  Evaluation of the effective operation of the 
structures and mechanisms provided for by the Health Security Initia tive will be based on 
information from Member States supplied annua lly, with scientific support from specialised 
agencies and organisations such as the ECDC , WHO and EMA. The reporting system will be 
approved and implemented by the new committee. 
A more detailed inventory of existing capacities, measures and plans in terms of preparedness, 
risk assessment and risk management and co mmunication at the level of each Member State 
and for all threats other than communicable dise ases is currently bei ng drawn up. It will allow 
indicators to be further refined and serve as  the benchmark against which progress will be 
measured after approval of the legal initiative. 
10. ANNEX  
Table 3: Overview of measures proposed under the three options 
 
EN 13   EN ANNEX: Table 3: 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 implementation of 
guidance on generic and pandemic preparedness; 
organise exercises and training; 
exchange best practice Shared approach to preparedness 
planning; identify core capacity standards related to 
IHR requirements; 
guidance on improved cross-sectoral preparedness and interoperability Common EU framework for MS to: 
- put in place common features of preparedness planning; - report regularly on implementation of preparedness plans; 
- cooperate in cross-sectoral preparedness and response planning; 
- implement requirements on common minimum core capacity standards; - agree and implement EU tailor-made criteria for notification of serious 
cross-border health threats at EU level
 
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 fo r the 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 Member States to 
notify threats with tailor-made EU criteria; 
improve coordination for risk monitoring 
and assessment by informal arrangements; 
develop Memoranda of Agreement with 
entities dealing with alert systems 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 committee  Improve cohe rence 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 action,  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 
the crisis management process and link communicators directly to risk 
managers/decision makers