# EUR-Lex - 52011PC0866 - EN

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# 52011PC0866

**Proposal for a DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on serious cross-border threats to health /* COM/2011/0866 final - 2011/0421 (COD) */**

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EXPLANATORY MEMORANDUM

1.
CONTEXT OF THE PROPOSED ACT
1.1.
Reasons for and objectives of the proposal

The
aim of the proposed Decision is to streamline and strengthen European Union
capacities and structures for effectively responding to serious cross-border health
threats. These threats can be events caused by communicable diseases,
biological agents responsible for non-communicable diseases, and threats of
chemical, environmental, or unknown origin[1].
Threats deriving from the effects of climate change (i.e. heat waves, cold
spells) are included in the scope of this Decision and covered under the same
heading as environmental threats.

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

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

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

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

So
far, EU legislation in this area only addresses threats related to communicable
diseases[2].
The EU network for surveillance and control of communicable diseases has
specific mechanisms for monitoring communicable diseases, giving alerts and
coordinating the EU response. Because its scope is limited to communicable
diseases, however, the network no longer meets the current standards or needs
for an improved EU response to all serious cross-border health threats and will
therefore be replaced by this Decision. The Decision covers all serious
cross-border threats to health except for those caused by radiological or
nuclear exposure.

The objectives of the proposed Decision are
as follows:

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

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

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

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

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

1.2.
General context

The proposal will help implement the
European Health Strategy[3]
and also contribute to Europe 2020[4]
by promoting health as an integral part of the smart and inclusive growth
objectives. The proposal will also contribute to implementing the Internal
Security Strategy in its crises and disasters management component[5], notably the overall objective
to establish a coherent risk management policy linking threat and risk
assessment to decision making. The Health Security
Initiative will appropriately take into account the EU external cooperation
activities for health crises prevention and responses with third countries and activities supported under the Union's programmes for research, and explore synergies with the numerous bilateral EU assistance and
cooperation programmes with a significant health component.

Many activities related to preparedness and
response planning and risk assessment for communicable diseases but also for
chemical threats to health and events caused by climate change have been
supported by the previous and current health programme. It is planned that for
important elements of the initiative, specific actions will be supported by the
future Health programme currently under development[6].

The EU already has policies, mechanisms and
instruments in place for the prevention and control of serious cross-border
threats and for the development of capacities to manage crises. A
non-exhaustive list includes the EU Civil Protection Mechanism, the Cohesion
and Solidarity Funds, the EU action plan on chemical, biological, radiological
and nuclear security[7],
and European alert networks such as ECURIE[8].

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

In order to avoid overlaps with these areas
and duplicating existing disaster prevention and control structures, a gap
analysis has been carried out to assess how far these existing systems cover
the monitoring of threats to health, their notification, risk assessment and
crisis management capacities and structures from the public health perspective.
This gap analysis revealed that the existing structures and mechanisms at EU
level do not address these threats sufficiently[9]
as far as public health is concerned. For example, there is a variety of
monitoring and alert systems for different threats at EU level, but these are
not systematically linked to EU public health institutions. In addition, the
International Health Regulations (IHR) (2005)[10]
— an international treaty for the coordination of all health emergencies —
stipulate that Member States must notify the World Health Organisation of any
event that may constitute a public health emergency of international concern,
independently of its origin (including biological, chemical or environmental).
But there are no similar notification obligations at EU level under any of the
existing structures.

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

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

As
regards preparedness planning, during the H1N1 influenza pandemic in 2009, Member
States procuring pandemic influenza vaccines individually were competing with
each other for limited amounts of available vaccine, which weakened their
purchasing power. Contractual confidentiality clauses often prevented Member
States from exchanging information, leading – as shown in an independent
evaluation[11]
– to considerable variations between Member States as regards contractual
conditions, particularly regarding liability for side effects being transferred
from the manufacturers to the Member States. In addition, the lack of
flexibility in contracts to include conditions under which the reserved amount
of doses could be changed or excess vaccines could be returned resulted in a
huge waste of resources. The Member States that could not accept those
unfavourable conditions had no guarantee of being able to obtain pandemic
influenza vaccines, thus weakening the preparedness across the EU for such a
cross-border health threat. This could have had very serious health
consequences if the pandemic had proved more virulent and deadly.

Furthermore, in the aftermath of the H1N1
pandemic in 2009, the European Parliament in its resolution of 8 March 2011 and
the Council in its conclusions of 13 September 2010[12] stressed the need to introduce
a common procedure for the joint procurement of medical countermeasures, and in
particular of pandemic vaccines, to allow Member States, on a voluntary basis,
to benefit from such purchases.

This proposal provides a legal basis for an
EU mechanism for the joint procurement of medical countermeasures in which
contracting parties[13]
could participate on a voluntary basis in order to purchase medical countermeasures,
such as pandemic influenza vaccines, thereby improving preparedness for future
pandemics.

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

The Health Security Committee is currently
an informal structure at EU level for the coordination of public health risk
assessment and the management of serious cross-border threats to health. It was
set up by the EU health ministers in the aftermath of the 11 September 2001
terrorist attacks in the United States. At the beginning, its mandate was
limited to tackling bioterrorism[14],
but it has subsequently been extended to cover all types of public
health-related crisis[15].
It is composed of representatives of the Member States’ health authorities and
chaired by the Commission.

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

1.3.
Existing European Union and international
provisions in this area

The
Community network for the epidemiological surveillance and control of
communicable diseases established under Decision No 2119/98/EC comprises the
epidemiological surveillance of communicable diseases and the Early Warning and
Response System (EWRS). Regulation (EC) No 851/2004 of the European Parliament
and of the Council of 21 April 2004 establishing a European Centre for Disease
Prevention and Control[16]
(ECDC) provides the ECDC with a mandate covering surveillance and risk
assessment of threats to human health from communicable diseases and illnesses
of unknown origin. In this context, the ECDC has taken over the epidemiological
surveillance of communicable diseases and the operation of the EWRS from the
Community network. For this reason the proposed Decision repeals Decision No
2119/98/EC.

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

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

Furthermore,
EU secondary legislation establishes specific rules for monitoring, giving
early warning of and combating serious cross-border threats to health (e.g. the
Seveso II Directive[18]
and the CAFE Directive[19])
and requires in a few instances Member States to develop joint activities to
address transboundary air pollution including recommended behaviour (CAFE
Directive). For these reasons this Decision does not impinge on the provisions
that already exist but seeks to close the gaps in relation to notifications,
monitoring, risk assessment and crisis management from the public health
perspective. Therefore, the Decision extends the Early Warning and Response
System to cover all serious cross-border threats to health (except radio
nuclear), adds a monitoring requirement in a crisis for threats to health other
than communicable diseases and provides for a crisis management structure for
addressing health threats, as these are not covered under other legislation.

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

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

2.
RESULTS OF CONSULTATIONS WITH INTERESTED PARTIES
2.1.
Consultation with interested parties and use of
expertise

The open stakeholder consultation on health
security in the European Union took place between 4 March and 31 May 2011. In
all 75 responses to the online questionnaire were received: 21 on behalf of
national, regional or local authorities, 31 on behalf of organisations and 23
from individual citizens[20].

The key outcome of these stakeholder
consultations is that most stakeholders are strongly in favour of having all
serious cross-border health threats included in the EU health security policy[21].

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

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

2.2.
Impact assessment

The Commission has carried out detailed
analysis of three options:

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

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

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

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

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

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

3.
LEGAL ELEMENTS OF THE PROPOSAL
3.1.
Legal basis

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

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

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

3.2.
Subsidiarity

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

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

Since the objectives of the action to be
taken cannot be sufficiently achieved by the Member States alone due to the
cross-border aspects of those threats and can therefore, for reasons of
effectiveness, be better achieved at EU level, the EU may adopt measures, in
accordance with the principle of subsidiarity as set out in Article 5 of the
Treaty on European Union. In accordance with the principle of proportionality,
as set out in that Article, the proposed Decision does not go beyond what is
necessary in order to achieve those objectives.

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

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

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

4.
BUDGETARY IMPLICATIONS

This legal proposal does not impact on
decentralised agencies.

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

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

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

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

2011/0421 (COD)

Proposal for a

DECISION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on serious cross-border threats to health

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 168, paragraphs (4)(c)
and (5) thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the
European Economic and Social Committee[22],

Having regard to the opinion of the
Committee of the Regions[23],

Having regard to the opinion of the European
Data Protection Supervisor[24],

Acting in accordance with the ordinary
legislative procedure[25],

Whereas:

(1)
Article 168 of the Treaty on
the Functioning of the European Union states, inter alia, that the
Union's action in the field of public health should cover monitoring, early
warning of and combating serious cross-border threats to health, and that a
high level of human health protection is to be ensured in the definition and
implementation of all Union policies and activities. According to the same
provision, Member States must, in liaison with the Commission, coordinate among
themselves their policies and programmes in the areas covered by the Union
action in the field of public health.

(2)
By Decision No 2119/98/EC of the European
Parliament and of the Council of 24 September 1998[26]
a network on the epidemiological surveillance and control of communicable
diseases in the Community was set up. Experience gained in the implementation
of that Decision confirms that coordinated Union action on monitoring, early
warning of and combating those threats adds value to the protection and
improvement of human health. However, a number of developments at Union and
international level in the past decade make a review of that legal framework
necessary.

(3)
Apart from communicable diseases, a number of
other sources of danger to health, notably related to other biological agents,
chemical agents or environmental events, which include hazards related to
climate change, may, by reason of their scale or severity, endanger the health
of citizens in the entire Union, lead to the malfunctioning of critical sectors
of society and economy and jeopardise individual Member State's capacity to
react. Therefore, the legal framework set up under Decision No 2119/98/EC
should be extended to cover these other threats and provide for a coordinated
wider approach to health security at Union level.

(4)
An important role in the coordination of recent
crises of Union relevance has been played by the Health Security Committee, an
informal group composed of high level representatives from Member States and
established on the basis of the Presidency Conclusions of 15 November 2001 on
bioterrorism[27]. It is necessary to
integrate this group into a formalised institutional framework and to assign it
a well-defined role avoiding duplications with other Union entities responsible
for risk management, not least that established under Decision No 2119/98/EC.

(5)
Regulation (EC) No 851/2004 of the European
Parliament and of the Council of 21 April 2004 establishing a European Centre
for Disease Prevention and Control[28] (ECDC) provides the ECDC
with a mandate covering surveillance, detection and risk assessment of threats
to human health from communicable diseases and outbreaks of unknown origin. The
ECDC has progressively taken over the epidemiological surveillance of
communicable diseases and the operation of the Early Warning and Response
System from the Community network set up under Decision No 2119/98/EC. This
development is not reflected in Decision No 2119/98/EC, which was adopted
before the creation of the ECDC.

(6)
The International Health Regulations (2005)
adopted by the Fifty-eighth World Health Assembly on 23 May 2005 reinforced the
coordination among States Parties to the World Health Organisation (WHO), which
include all the Member States of the Union, of the preparedness for and
response to a public health emergency of international concern. The legislation
of the Union should take this development into account, including the
integrated all-hazards approach of the WHO covering all categories of threats
independently of their origin.

(7)
This Decision should not apply to the serious
cross-border health threats arising from ionizing radiation, as those threats
are already covered by Article 2(b) and Chapter 3 of Title II of the Treaty
establishing the European Atomic Energy. Moreover, it should apply without
prejudice to other binding measures concerning specific activities or setting
the standards of quality and safety of some goods, which provide for special
obligations and tools for monitoring, early warning and combating specific
threats of cross-border nature.

(8)
Preparedness and response planning is an
essential element allowing for an effective monitoring, early warning of and
combating serious cross-border threats to health. Such planning should include
in particular adequate preparedness of critical sectors of society such as
energy, transport, communication or civil protection which rely, in a crisis
situation, on well-prepared public health systems that are also in turn
dependent on the functioning of those sectors and on maintenance of essential
services at an adequate level.

(9)
The International Health Regulations (2005)
already require Member States to develop, strengthen and maintain their capacity
to detect, assess, notify and respond to a public health emergency of
international concern. Coordination between the Member States is necessary to
achieve a consistent level of preparedness and interoperability between
national preparedness plans in view of the international standards, while
respecting Member States' competence to organise their health systems.

(10)
The European Parliament in its resolution of 8
March 2011[29]
and the Council in its Conclusions of 13 September 2010[30] stressed the need to introduce
a common procedure for the joint procurement of medical countermeasures, and in
particular of pandemic vaccines, to allow Member States, on a voluntary basis,
to benefit from such group purchases. With regard to pandemic vaccines, in the
context of limited production capacities at global level, such a procedure
would increase the availability of those products and ensure fairer access to
them among Member States participating in the joint procurement.

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

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

(13)
In order to ensure that the assessment of risks
to public health at the Union level from serious cross-border threats to health
is consistent as well as comprehensive from a public health perspective, the
available scientific expertise should be mobilised in a coordinated manner,
through appropriate channels or structures depending on the type of threat
concerned. This risk assessment should be based on robust scientific evidence and
independent expertise and provided by the Agencies of the Union in accordance
with their missions, or otherwise by expert groups set up by the Commission.

(14)
Effectively responding to serious cross-border
threats to health at national level requires a consistent approach among Member
States, in conjunction with the Commission, necessitating exchange of
information, consultation and coordination of actions. Under Decision No
2119/98/EC, the Commission already coordinates the response at the Union level
in collaboration with Member States with regard to communicable diseases. A
similar mechanism should apply to all serious cross-border threats to health
independently of their origin. It should also be recalled that, independently
from this Decision, a Member State may, in case of a major emergency, request
assistance under Council Decision of 8 November 2007 establishing a Community
Civil Protection Mechanism (2007/779/EC, Euratom)[31].

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

(16)
Inconsistent or confusing communication with the
public and stakeholders such as health professionals may have a negative impact
on the effectiveness of the response from a public health perspective as well
as on economic operators. Therefore, the coordination of the response at the
Union level should encompass shared information campaigns and consistent
communication messages to citizens based on robust and independent evaluation
of public health risks.

(17)
The applicability of some specific provisions of
Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional
marketing authorisation for medicinal products for human use falling within the
scope of Regulation (EC) No 726/2004 of the European Parliament and of the
Council[32]
and Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the
examination of variations to the terms of marketing authorisations for
medicinal products for human use and veterinary medicinal products[33], depends on the recognition at
Union level in the framework of Decision 2119/98/EC, of an emergency situation
or of a pandemic situation with respect to human influenza. Those provisions
allow for the accelerated marketing of certain medicinal products in case of
urgent needs, by means, respectively, of a conditional marketing authorisation
and of the temporary possibility to grant a variation to the terms of a
marketing authorisation for a human influenza vaccine even where certain
non-clinical or clinical data are missing. However, in spite of the utility of
such provisions in the event of a crisis, there is to date no specific
procedure for issuing such recognitions at Union level. It is therefore
appropriate to provide for such a procedure as part of the standards of quality
and safety for medicinal products.

(18)
The processing of personal data for the purpose
of implementing this Decision should comply with Directive 95/46/EC of the
European Parliament and of the Council of 24 October 1995 on the protection of
individuals with regard to the processing of personal data and on the free
movement of such data[34] and Regulation (EC) No
45/2001 of the European Parliament and of the Council of 18 December 2000 on
the protection of individuals with regard to the processing of personal data by
the Community institutions and bodies and on the free movement of such data[35].
In particular, the operation of the Early Warning and Response System should
provide for specific safeguards allowing safe and lawful exchange of personal
data for the purpose of contact tracing measures implemented by Member States
at national level.

(19)
Since the objectives of this Decision cannot be
sufficiently achieved by the Member States alone due to the cross-border
dimension of those threats and can, therefore, be better achieved at Union
level, the Union may adopt measures, in accordance with the principle of
subsidiarity as set out in Article 5 of the Treaty on European Union. In
accordance with the principle of proportionality, as set out in that Article,
this Decision does not go beyond what is necessary in order to achieve those objectives.

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

(21)
In order to ensure uniform conditions for the
implementation of this Decision, implementing powers should be conferred on the
Commission to adopt implementing acts in relation to: the procedures for the
coordination, the exchange of information and the mutual consultation on
preparedness and response planning; the adoption of a list of communicable
diseases subject to the network of epidemiological surveillance and the
procedures for the operation of such a network; the setting up and termination
of ad hoc monitoring networks and the procedures for the operation of such networks;
the adoption of case definitions for serious cross-border threats to health;
the procedures for the operation of the Early Warning and Response System; the
procedures for the coordination of the responses of the Member States; the
recognition of situations of emergency at Union level or of pre-pandemic
situations with respect to human influenza at Union level. Those implementing
powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and
of the Council of 16 February 2011 laying down the rules and general principles
concerning mechanisms for control by Member States of the Commission's exercise
of implementing powers[36].

(22)
In order to enhance clarity and legal certainty,
Decision No 2119/98/EC should be repealed and replaced by this Decision.

HAVE ADOPTED THIS DECISION

Chapter I
General provisions

Article 1
Subject matter

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

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

Article 2
Scope

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

(a) threats of biological origin,
consisting of:

(i) communicable diseases;

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

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

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

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

(d) threats of unknown origin;

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

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

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

Article 3
Definitions

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

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

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

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

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

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

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

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

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

Chapter II
Planning

Article 4
Preparedness and response planning

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

(a) the interoperability of national
preparedness plans;

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

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

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

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

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

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

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

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

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

Article 5
Joint procurement of medical countermeasures

1. The institutions of the Union and any
Member States which so desire may engage in a joint procurement procedure
conducted pursuant to the third subparagraph of Article 91(1) of Council Regulation
(EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation
applicable to the general budget of the European Communities[37] and Article 125c of Commission
Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed
rules for the implementation of the Council Regulation (EC, Euratom) No
1605/2002 on the Financial Regulation applicable to the general budget of the
European Communities[38],
with a view to the advance purchase of medical countermeasures against serious
cross-border threats to health.

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

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

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

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

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

Chapter III
Permanent surveillance and ad hoc monitoring

Article 6
Epidemiological
surveillance

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

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

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

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

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

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

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

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

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

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

Article 7
Ad hoc Monitoring Networks

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

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

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

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

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

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

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

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

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

Chapter IV
Early warning and
response

Article
8
Establishment of an early warning and response system

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

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

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

Article 9
Alert notification

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

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

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

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

2. Where the national competent authorities notify to the World Health Organization events that may constitute
public health emergencies of international concern in accordance with Article 6
of the International Health Regulations (2005), they shall at the latest
simultaneously notify an alert in the Early Warning and Response System,
provided that the threat concerned falls within those referred to in Article 2(1)
of this Decision.

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

(a) the type and
origin of the agent,

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

(c) means of transmission or dissemination,

(d) toxicological data,

(e) detection and confirmation methods,

(f) public health risks,

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

(h) measures other
than public health measures,

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

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

Article 10
Public health risk assessment

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

This assessment shall be based:

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

(b) on the opinion the European
Food Safety Authority in accordance with Article 23 of Regulation (EC) No
178/2002 of the European Parliament and of the Council of 28 January 2002
laying down the general principles and requirements of food law, establishing
the European Food Safety Authority and laying down procedures in matters of
food safety[39];
and/or

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

Article 11
Coordination of response

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

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

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

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

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

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

Article 12
Common temporary public
health measures

1. Where the coordination of national
responses provided for in Article 11 proves insufficient to control the spread
of a serious cross-border threat to health between the Member States or to the
Union, and, as a consequence, the protection of the health of the population of
the Union as a whole is jeopardised, the Commission may complement the action
of the Member States through the adoption, by means of delegated acts in
accordance with the procedure provided for in Article 22, of common temporary
public health measures to be implemented by the Member States. These measures
may not concern the control of the threat concerned within each Member State.

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

3. The measures adopted under paragraph 1 shall:

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

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

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

Chapter V
Emergency and pandemic
influenza situations at the
Union level

Article 13
Recognition of emergency
situations or of pandemic influenza situations

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

(a) situations of emergency at Union level;
or

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

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

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

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

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

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

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

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

(iii) is life-threatening;

(c) the medicinal products, including
vaccines, already authorised at Union level in accordance with Regulation (EC)
No 726/2004 of the European Parliament and of the
Council of 31 March 2004 laying down Community procedures for the authorisation
and supervision of medicinal products for human and veterinary use and
establishing a European Medicines Agency[40]
or in the Member States through the mutual recognition
procedure or decentralized procedure referred to in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on
the Community code relating to medicinal products for human use[41], are
not or may not be sufficiently efficient for the prevention or treatment of the
threat concerned;

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

Article 14
Legal effects of the recognition

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

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

Article 15
Termination of the recognition

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

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

Chapter VI
International agreements

Article 16
International agreements

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

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

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

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

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

Chapter VII
Procedural provisions

Article 17
Designation of national
authorities and representatives

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

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

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

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

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

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

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

Article 18
Protection of personal data

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

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

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

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

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

6. The Commission shall adopt:

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

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

Article 19
Health Security Committee

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

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

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

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

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

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

4. The secretariat shall be provided by the
Commission.

Article 20
Committee on serious
cross-border threats to health

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

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

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

Article 21

Exercise
of the delegation

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

2. The power to adopt delegated acts referred
to in Article 12 shall be conferred on the Commission for a period of
five years after [...][42].The
Commission shall draw up a report in respect of the delegation of power not
later than nine months before the end of the five‑year period. The
delegation of power shall be tacitly extended for periods of an identical
duration, unless the European Parliament or the Council opposes such
extension not later than three months before the end of each period.

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

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

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

Article 22
Urgency procedure

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

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

Article 23
Reports concerning this Decision

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

Chapter VIII
Final provisions

Article 24
Repeal of Decision 2119/98/EC

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

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

Article 25
Entry into force

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

Article 26
Addressees

This Decision is addressed to the Member States.

Done at Brussels,

For the European Parliament                       For
the Council

The President                                                 The
President

ANNEX

LEGISLATIVE FINANCIAL STATEMENT

5.
FRAMEWORK OF THE PROPOSAL/INITIATIVE
5.1.
Title of the proposal/initiative

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

Policy area(s) concerned in the ABM/ABB structure[43]

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

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

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

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

5.2.
Nature of the proposal/initiative

 ̈ The
proposal/initiative relates to a new action

 ̈ The
proposal/initiative relates to a new action following a pilot
project/preparatory action[44]

þ The proposal/initiative relates to the
extension of an existing action

 ̈ The
proposal/initiative relates to an action redirected towards a new action

5.3.
Objectives
5.3.1.
The Commission's multiannual strategic
objective(s) targeted by the proposal/initiative

HEALTH SECURITY

The general objectives of this initiative are to improve the
protection of the citizens of the European Union from serious cross-border
threats and to ensure a high level of human health protection in defining and
implementing EU policies and activities. Capacities and structures will be
strengthened and measures concerning monitoring, early warning of and combating
serious cross-border threats to health as set out in Article 168 of the TFEU
are envisaged.

5.3.2.
Specific objective(s) and ABM/ABB activity(ies)
concerned

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

Specific objective No. 1:

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

ABM/ABB activity(ies) concerned

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

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

Administrative expenditure of the 'Commission's administration'
policy area – Personnel policy and management - Medical service (26 01 50 01)[45]

Specific objective No. 2:

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

ABM/ABB activity(ies) concerned

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

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

Specific objective No. 3:

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

ABM/ABB activity(ies) concerned

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

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

Specific objective No. 4:

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

ABM/ABB activity(ies) concerned

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

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

5.3.3.
Expected result(s) and impact

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

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

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

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

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

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

Impact at international level. Better
coordination in the EU of implementation of the International Health
Regulations (2005)[46]
by the Member States and closer collaboration between the EU and the WHO on
preparedness for and response to public health emergencies of international
concern would contribute to enhancing global health security.

5.3.4.
Indicators of results and impact

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

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

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

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

The main instrument for gathering data for the purpose of such an
evaluation will be a reporting system that will be approved and implemented by
the new health committee. The competent authorities in the Member States, the
European Centre of Disease Prevention and Control and the Commission will
cooperate closely to develop the required tools and instruments. Involvement of
other international bodies such as the World Health Organisation and the Global
Health Security Initiative (GHSI)[47]
may be considered where appropriate.

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

Monitoring the implementation of
suggested actions

Impact Indicators

Specific Objectives || Result Indicators || Source of Information

1. Improved protection of citizens of the EU from serious cross-border threats to health || More rapid and effective defeat of cross-border threats to the health of EU citizens (morbidity, mortality, Quality Adjusted Life Years Saved) || External and independent evaluation four years after implementation of the legal basis

2. Public health security structures and systems: Effectiveness[48], efficiency[49] and coherence[50] 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 || Regular 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-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 || 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 participating, amount of medical counter-measures purchased through this mechanism || annual reports of competent authorities in Member States based on an agreed questionnaire continuous ECDC assessment of preparedness at national level for communicable diseases synthesis reports by the Commission every two years with a qualitative evaluation of the implementation by the Member States

· 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 place for assessment of health threats, regardless of their cause (number of networks in place and number of types of threats covered) number of risk assessments, type of threats assessed, structures that assessed the risk and quality of risk assessments requested and performed || Report from the Commission

· 2.4. risk management: improved coordination – · - sustainable structure at EU level for any serious cross-border public health crisis; · - clear mandate for this structure with strong commitment of Member States || Sustainable mechanism (operational EU health group) and structure in place for EU wide crisis management Standard Operation procedures for crisis management agreed with Member States internal rules of procedures established for a unique structure (level of participation of Member States, number and quality of recommendations issued) || Report from the Commission

2.5.crisis communication: improved conditions for crisis communication || Agreement on reinforced operating procedures for risk and crisis communication (who, why, when, where, how, what) 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

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

5.4.
Grounds for the proposal/initiative
5.4.1.
Requirement(s) to be met in the short or long
term

The aim of the Health Security Initiative (HSI) is to streamline and
strengthen capacities and structures on health security in order to improve the
protection of the citizens of the European Union (EU) from all serious
cross-border threats that may affect public health. These threats can be events
caused by communicable diseases, biological agents causing diseases that are
not communicable[51],
and threats of chemical, environmental or unknown origin, or caused by climate
change. Threats emerging from the effects of climate change (i.e. heat waves,
cold spells) are covered by environmental threats throughout the initiative.

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

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

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

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

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

- the public health aspects of crisis management and the public
health measures required under such circumstances to prevent or limit the
spread of public health threats and mitigate the effects of such events.[53]. In this context, the impact
assessment will also elaborate on the status of the Health Security Committee[54] (HSC) and will look into ways
to ensure effective communication.

5.4.2.
Added value of EU involvement

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

5.4.3.
Lessons learned from similar experiences in the
past

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

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

The management of Pandemic Influenza H1N1 was thoroughly evaluated[55].

Lessons learnt at EU level and key messages endorsed by the Health
Security Committee include the following[56]:Member
States, the Commission and EU Agencies continue to evaluate pandemic
preparedness for sectors and services identified as potentially at risk,
(health and cross-sectoral), particularly as not all sectors experienced
similar levels of pressure. Member States, the Commission and EU Agencies
refine and publicise estimates of pandemic planning assumptions for a new
pandemic as early as possible to enable other sectors to prepare, and ensure
that these are reviewed as the pandemic progresses. Member States incorporate
planning for the provision of mutual aid as part of generic business continuity
planning for health services, including health sector supply and support
services.

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

Under the current EU communicable disease legislation EU
surveillance and a case definition for H1N1 were agreed rapidly on the basis of
ECDC and WHO advice. However, the statements by the Health Security Committee
on vaccination coverage[57],
on travel advice[58]
and on school closures[59]
during the pandemic were hard to reach, slow to be agreed, and not always
followed up by the Member States, given the informal nature of that committee.
It was also not possible, owing to regulatory and contractual limitations, to
rapidly come up with a mechanism for ensuring a supply of antivirals and
vaccines[60].

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

Member States wishing to secure pandemic influenza vaccines were
pitched against each other and had to accept disadvantageous contractual
conditions. Evidence that was gathered for the Commission in an independent
evaluation[62]
shows the considerable variations in contractual conditions, particularly
regarding liability for side effects being transferred from the manufacturers
to the Member States. In addition, the lack of flexibility in contracts to
include conditions under which the reserved amount of doses could be changed or
excess vaccines could be returned resulted in an enormous waste of resources.
The Member States that could not accept those unfavourable conditions had no
guarantee at all of being able to obtain pandemic influenza vaccines, thus
weakening the preparedness across the EU against such cross-border health
threat. This could have had very serious health consequences if the pandemic
had proved more virulent and deadly.

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

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

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

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

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

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

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

The Commission played an active role in order to reduce the
financial burden incurred by this crisis. A EUR 210 million aid package was
immediately adopted and further EUR 75.1 million of shared aids with MS are
aimed to the promotion of agricultural products in the next three years.

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

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

There was also a problem concerning public risk assessment in
relation to the melamine milk contamination event in 2008.[64] Based on their
knowledge, the food safety authorities did not see a risk for adults in Europe.
However, public health authorities had to address citizen's concerns about
longer term effects, particularly for travellers returning from China who had
been at risk of having consumed contaminated milk and composite products. There
was no possibility to have a comprehensive and rapid public health risk
assessment and also no possibility to enable surveillance of exposed persons in
the short, medium or long term.

Concerning chemical events, a series of table top exercises
have been run in 2011 ("Iridium") to simulate incidents caused by
dangerous chemicals, based on real life events. For example, a leaking
container on a ferry on the Baltic Sea caused illness in passengers and ship
workers that came in contact with the chemical, but they had to travel on to
their destinations. They presented unusual and non-specific symptoms[65].

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

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

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

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

5.4.4.
Coherence and possible synergy with other
relevant instruments

In a more general strategic framework, the health security
initiative will help implement the European Health Strategy[66] and also contribute to the
objectives of Europe 2020[67]
by promoting health as an integral part of the smart and inclusive growth
objectives. Furthermore, it will contribute to the overall European Security
context and will build on existing instruments and strategies related to
disaster prevention and control.

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

The EU has a series of policies, mechanisms and instruments to cater
for prevention and control of serious cross border threats to health and develop
capacities to manage crises[68].
A non-exhaustive list includes the civil protection mechanism, the Internal
Security Strategy, the Cohesion and Solidarity Funds, pan-European alert
networks such as ECURIE, to name only a few[69].

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

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

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

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

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

- scientific committees (on consumer products, health and
environment risks and newly identified health risks) are in charge of risk
assessment, depending on the type of threat[70];

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

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

The initiative will help put in place the EU Internal Security
Strategy[71],
which makes specific reference to the health security initiative.

The initiative will be instrumental to strengthen chemical and
biological security in the EU as set out in the CBRN action plan[72]. The close
cooperation that is ongoing between Member States' authorities and agencies and
DG HOME and SANCO, backed up by Europol and the European Centre for Disease
Prevention and Control, and which is undertaken in the framework of the
“bridging security and health” arrangement will be reinforced through improved
cross border health threats preparedness and response as a result of the
initiative.

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

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

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

5.5.
Duration and financial impact

 ̈ Proposal/initiative of limited
duration

–
 ̈  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY

–
 ̈  Financial impact from YYYY to YYYY

þ Proposal/initiative of unlimited
duration

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

5.6.
Management mode(s) envisaged[75]

þ Centralised direct management by the Commission

þ Centralised indirect management with the delegation of implementation tasks to:

–
 ̈  executive agencies

–
þ  bodies set up by the Communities[76]

–
 ̈  national public-sector bodies/bodies with public-service mission

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

 ̈ Shared management with the Member States

 ̈ Decentralised management with third countries

 ̈ Joint management with international organisations (to be specified)

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

Comments

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

6.
MANAGEMENT MEASURES
6.1.
Monitoring and reporting rules

Specify frequency
and conditions.

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

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

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

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

6.2.
Management and control system
6.2.1.
Risk(s) identified

The main risks are the following:

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

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

6.2.2.
Control method(s) envisaged

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

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

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

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

- Controls before and during the implementation of contracts:

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

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

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

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

- Controls at the end of the contract:

DG SANCO has a centralised audit team which verifies
on-the-spot the eligibility of cost claims. The aim of these controls is to
prevent, detect and correct material errors related to the legality and
regularity of financial transactions. With a view to achieving a high control
impact, the selection of contractors to be audited foresees to (a) combine
a risk based selection with a random sampling, and (b) pay attention to
operational aspects whenever possible during the on-site audit.

- Costs and benefits of controls:

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

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

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

6.3.
Measures to prevent fraud and irregularities

Specify existing or
envisaged prevention and protection measures.

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

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

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

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

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

7.
ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE
7.1.
Heading(s) of the multiannual financial
framework and expenditure budget line(s) affected

· Existing expenditure budget lines

In order of
multiannual financial framework headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Description........................................] || Diff./non-diff. ([77]) || from EFTA[78] countries || from candidate countries[79] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

3. Security and citizenship || 17 03 06 Union action in the field of health || Diff. || YES || YES || NO || NO

3. Security and citizenship || 17 01 04 Programme of the European Union action in the field of health – Expenditure on administrative management || non-diff. || YES || YES || NO || NO

5. Administration || 17 01 02 11 External staff and other management expenditure in support of the ‘Health and consumer protection’ policy area – Other management expenditure || non-diff. || YES || YES || NO || NO

5. Administration || 26 01 50 01 Administrative expenditure of the 'Commission's administration' policy area – Personnel policy and management – Medical service || non-diff. || NO || NO || NO || NO

· New budget lines requested

In order of multiannual financial framework
headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Heading............................................] || Diff./non-diff. || from EFTA countries || from candidate countries || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

|| || || || || ||

7.2.
Estimated impact on expenditure
7.2.1.
Summary of estimated impact on expenditure

EUR million (to 3 decimal places) in current prices

Heading of multiannual financial framework: || Number 3 || Security and citizenship

DG: SANCO || || || Year 2013[80] || Year 2014 || Year 2015 || Subsequent years || TOTAL[81]

Ÿ Operational appropriations || || || || ||

17 03 06 || Commitments || (1) || 2.081 || 2.123 || 2.165 || =(commitment year-1)*1.02 ||

Payments || (2) || 0.694 || 1.415 || 2.165 || ||

Budget line || Commitments || (1a) || || || || ||

Payments || (2a) || || || || ||

Appropriations of an administrative nature financed  from the envelope for specific programmes[82] || || || || ||

17 01 04 || || (3) || 0.084 || 0.086 || 0.088 || =(commitment year-1)*1.02 ||

TOTAL appropriations for DG SANCO || Commitments || =1+1a +3 || 2.165 || 2.209 || 2.253 || ||

Payments || =2+2a +3 || 0.778 || 1.501 || 2.253 || ||

Ÿ TOTAL operational appropriations || Commitments || (4) || 2.081 || 2.123 || 2.165 || =(commitment year-1)*1.02 ||

Payments || (5) || 0.694 || 1.415 || 2.165 || ||

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || 0.084 || 0.086 || 0.088 || =(commitment year-1)*1.02 ||

TOTAL appropriations under HEADING 3 Security and citizenship of the multiannual financial framework || Commitments || =4+ 6 || 2.165 || 2.209 || 2.253 || ||

Payments || =5+ 6 || 0.778 || 1.501 || 2.253 || ||

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

Ÿ TOTAL operational appropriations || Commitments || (4) || || || || ||

Payments || (5) || || || || ||

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || ||

TOTAL appropriations under HEADINGS 1 to 4 of the multiannual financial framework (Reference amount) || Commitments || =4+ 6 || || || || ||

Payments || =5+ 6 || || || || ||

Heading of multiannual financial framework: || 5 || " Administrative expenditure "

EUR million (to 3 decimal places) in current prices

|| || || Year2013 || Year 2014 || Year 2015 || Subsequent years || TOTAL

DG: SANCO ||

Ÿ Human resources (17 01 01 01) || 0;540 || 0.540 || 0.540 || 0.540 ||

Ÿ Other administrative expenditure (17 01 02 11) || 0.096 || 0.096 || 0.096 || 0.096 ||

TOTAL DG SANCO || Appropriations || || || || ||

|| || || Year 2013 || Year 2014 || Year 2015 || ... enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL

DG: HR ||

Ÿ Human resources [83] || || || || || || ||

Ÿ Other administrative expenditure (26 01 50 01) || 0.030 || || || || || ||

TOTAL DG HR || Appropriations || 0.030 || || || || || ||

TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || || || || || || ||

EUR million (to 3 decimal places)

|| || || Year N[84] || Year N+1 || Year N+2 || ... enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL

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

Payments || || || || || || ||

7.2.2.
Estimated impact on operational appropriations

–
 ̈  The proposal/initiative does not require the use of operational
appropriations

–
þ  The proposal/initiative requires the use of operational
appropriations, as explained below:

Indicate objectives and outputs ò || || Year 2013 || Year 2014 || Year 2015 || TOTAL

OUTPUTS

Type of output[85] || Average cost of the output || Number of outputs[86] || Cost || Number of outputs[87] || Cost || Number of outputs || Cost || Total number of outputs[88] || Total cost

SPECIFIC OBJECTIVE No 1[89] Preparedness and response planning || || || || || || || || || || || ||

output || New preparedness plans established at EU and national level || || 1 || 0.066 || 0 || 0.000 || 0 || 0.000 || 1 || 0.066

output || Further developed generic preparedness principles (possible detailed provisions for specific threats) || || 1 || 0.066 || 1 || 0.066 || 1 || 0.066 || 3 || 0.198

output || Preparedness and response planning in critical sectors of society || || 1 || 0.066 || 0 || 0.000 || 0 || 0.000 || 1 || 0.066

output || Agreements on minimum core capacities and shared standards at EU level to address IHR || || 1 || 0.066 || 1 || 0.066 || 1 || 0.066 || 3 || 0.198

output || Proposal to set up a joint procurement mechanism and its implementation: countries participating, medical counter-measures purchased through this mechanism || || 1 || 0.066 || 0 || 0.000 || 0 || 0.000 || 1 || 0.066

Sub-total for specific objective N°1 || || || 5 || 0.330 || 2 || 0.132 || 2 || 0.132 || 9 || 0.594

SPECIFIC OBJECTIVE No 2 Risk monitoring and assessment || || || || || || || || || || || || || ||

output || Standard operation procedures in place and memoranda of understanding agreed with relevant sectors to closer link existing notification structures || || 1 || 0.050 || 1 || 0.050 || 1 || 0.050 || 3 || 0.150

|| EU tailor-made criteria implemented for notification of health threats agreed at EU level || || 1 || 0.050 || 0 || 0.000 || 0 || 0.000 || 1 || 0.050

|| Links to IHR established || || 1 || 0.050 || 0 || 0.000 || 0 || 0.000 || 1 || 0.050

|| Strengthened capacities in place for assessment of health threats, regardless of their cause, and networks in place || || 3 || 0.100 || 0 || 0.000 || 0 || 0.000 || 3 || 0.100

Sub-total for specific objective N°2 SPECIFIC OBJECTIVE No 3 Risk management || || || 6 || 0.250 || 1 || 0.050 || 1 || 0.050 || 8 || 0.350

SPECIFIC OBJECTIVE No 3 Risk management ||

output || Sustainable mechanism (operational EU health group) and structure in place for EU wide crisis management || || 1 || 0.063 || 0 || 0.000 || 0 || 0.000 || 1 || 0.063

output || Standard Operation procedures for crisis management agreed with Member States || || 1 || 0.063 || 0 || 0.000 || 0 || 0.000 || 1 || 0.063

output || Internal rules of procedures established for a unique structure (level of participation of Member States) || || 1 || 0.062 || 0 || 0.000 || 0 || 0.000 || 1 || 0.062

output || Committee in charge of implementing acts put in place || || 1 || 0.062 || 0 || 0.000 || 0 || 0.000 || 1 || 0.062

Sub-total for specific objective N°3 || || || 4 || 0.250 || 0 || 0.000 || 0 || 0.000 || 4 || 0.250

SPECIFIC OBJECTIVE No 4 Risk and crisis communication || || || || || || || || || || || || || ||

output || Agreement on reinforced operating procedures for risk and crisis communication (who, why, when, where, how, what) || || 1 || 0.050 || 0 || 0.000 || 0 || 0.000 || 1 || 0.050

output || Campaigns implemented; exercises carried out; common press statements, communication tools, brochures, guidance documents, posters etc produced; || || 3 || 1.201 || 5 || 1.941 || 5 || 1.983 || 13 || 5.125

Sub-total for specific objective N°4 || || || 4 || 1.251 || 5 || 1.941 || 5 || 1.983 || 14 || 5.175

TOTAL COST || || 0.193 || 19 || 2.081 || 8 || 2.123[90] || 8 || 2.165[91] || 35 || 6.369

7.2.3.
Estimated impact on appropriations of an
administrative nature
7.2.3.1.
Summary

–
 ̈  The proposal/initiative does not require the use of administrative
appropriations

–
þ  The proposal/initiative requires the use of administrative
appropriations, as explained below:

EUR million (to 3
decimal places) in current prices

|| Year 2013 [92] || Year 2014 || Year 2015 || Subsequent years || TOTAL

HEADING 5 of the multiannual financial framework || || || || ||

Human resources || 0.540 || 0.540 || 0.540 || ||

Other administrative expenditure (17 01 02 11) || 0.096 || 0.096 || 0.096 || 0.096 ||

Administrative expenditure of the 'Commission's administration' policy area – Personnel policy and management - Medical service (26 01 50 01 || 0.030 || || || ||

Subtotal HEADING 5 of the multiannual financial framework || || || || ||

Outside HEADING 5[93] of the multiannual financial framework || || || || ||

Human resources || || || || ||

Other expenditure of an administrative nature (17 01 04) || 0.084 || 0.086 || 0.088 || =(commitment year-1)*1.02 ||

Subtotal outside HEADING 5 of the multiannual financial framework || || || || ||

TOTAL || || || || ||

7.2.3.2.
 Estimated requirements of human resources

–
 ̈  The proposal/initiative does not require the use of human
resources

–
þ  The proposal/initiative requires the use of human resources, as
explained below:

Estimate to be expressed in full amounts
(or at most to one decimal place)

|| Year 2013 || Year 2014 || Year 2015 || Year N+3 || ... enter as many years as necessary to show the duration of the impact (see point 1.6)

Ÿ Establishment plan posts (officials and temporary agents)

17 01 01 01 (Headquarters and Commission’s Representation Offices) ||  4 ||   4 ||  4 || 4 || 4 || 4 || 4

XX 01 01 02 (Delegations) || || || || || || ||

XX 01 05 01 (Indirect research) || || || || || || ||

10 01 05 01 (Direct research) || || || || || || ||

Ÿ External personnel (in Full Time Equivalent unit: FTE)[94]

XX 01 02 01 (CA, INT, SNE from the "global envelope") || 0.5 || 0.5 || 0.5 || 0.5 || 0.5 || 0.5 || 0.5

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

XX 01 04 yy [95] || - at Headquarters[96] || || || || || || ||

- in delegations || || || || || || ||

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

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

Other budget lines (specify) || || || || || || ||

TOTAL || 4.5 || 4.5 || 4.5 || 4.5 || 4.5 || 4.5 || 4.5

XX is the
policy area or budget title concerned.

The human resources required
will be met by staff from the DG who are already assigned to management of the action
and/or have been redeployed within the DG, together if necessary with any
additional allocation which may be granted to the managing DG under the annual
allocation procedure and in the light of budgetary constraints.

Description of
tasks to be carried out:

Officials and temporary agents ||

External personnel ||

7.2.4.
Compatibility with the current multiannual
financial framework

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

–
 ̈  Proposal/initiative will entail reprogramming of the relevant
heading in the multiannual financial framework.

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

–
 ̈  Proposal/initiative requires application of the flexibility
instrument or revision of the multiannual financial framework[97].

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

7.2.5.
Third-party contributions

–
þ  The proposal/initiative does not provide for co-financing by third
parties

–
 ̈  The proposal/initiative provides for the co-financing estimated
below:

Appropriations in EUR million (to 3 decimal places)

|| Year N || Year N+1 || Year N+2 || Year N+3 || ... enter as many years as necessary to show the duration of the impact (see point 1.6) || Total

Specify the co-financing body || || || || || || || ||

TOTAL appropriations cofinanced || || || || || || || ||

7.3.
Estimated impact on revenue

–
þ  Proposal/initiative has no financial impact on revenue.

–
 ̈  Proposal/initiative has the following financial impact:

 ̈         on own resources

 ̈         on miscellaneous revenue

EUR million (to 3 decimal places)

Budget revenue line: || Appropriations available for the ongoing budget year || Impact of the proposal/initiative[98]

Year N || Year N+1 || Year N+2 || Year N+3 || ... insert as many columns as necessary in order to reflect the duration of the impact (see point 1.6)

Article ............. || || || || || || || ||

[1]               Including threats of malicious intentional origin

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

[3]               White Paper of 23 October 2007 — Together for Health:
A Strategic Approach for the EU 2008-2013, COM(2007) 630 final

[4]               Communication from the Commission of 3 March 2010 — Europe
2020: A strategy for smart, sustainable and inclusive growth, COM(2010) 2020
final

[5]               EU Internal Security Strategy
in Action: Five steps towards a more secure Europe, 22.11.2010 -COM(2010) 673
final – Objective 5: Increase Europe's resilience to crises and disasters –
Action 2: an all-hazards approach to threat and risk assessment

[6]               http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:301:0003:0013:EN:PDF;
http://ec.europa.eu/health/programme/docs/prop_prog2014_en.pdf

[7]               Communication from the Commission of 24 June 2009 to
the European Parliament and the Council on Strengthening Chemical, Biological,
Radiological and Nuclear Security in the European Union – an EU CBRN Action
Plan COM(2009) 273 final

[8]               European Community Urgent Radiological Information
Exchange (ECURIE).

[9]               Please refer to the impact assessment report
for further details, in particular Appendix 2 ‘Structures for preparedness and
response to cross-border health threats’.

[10]             http://www.who.int/ihr/en/

[11]             http://ec.europa.eu/health/communicable_diseases/docs/assessment_vaccine_en.pdf

[12]             Council
Conclusions of 13 September 2010 on lessons learned from the A/H1N1 pandemic — health
security in the European Union (12665/10).

[13]             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)

[14]             Presidency Conclusions of 15 November 2001 on bioterrorism
(13826/01)

[15]             Council Conclusions of 22 February
2007 on the transitional prolongation and extension of the mandate of the HSC (6226/07)

[16]             OJ L 142, 30.4.2004, p. 1

[17]             Directive 2010/65/EU of the European Parliament and of
the Council of 20 October 2010 on reporting formalities for ships arriving in
and/or departing from ports of the Member States and repealing Directive
2002/6/EC, OJ L 283, 29.10.2010, p. 1

[18]             Council
Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards
involving dangerous substances (OJ L 10, 14.1.1997, p. 13)

[19]             Directive 2008/50/EC of the European Parliament and of
the Council of 21 May 2008 on ambient air quality and cleaner air for Europe (OJ
L152, 11.6.2008, p.1)

[20]             Report
on the Stakeholder Consultation on Heath Security in the European Union:

http://ec.europa.eu/health/preparedness_response/docs/healthsecurity_report_en.pdf

[21]             Please see the outcome of the consultation in the
impact assessment report

[22]               OJ C , , p.

[23]               OJ C , , p.

[24]               OJ C , , p.

[25]               Position of the European Parliament of 5 July 2011
(not yet published in the Official Journal) and decision of the Council of 27
July 2011

[26]               OJ L 268, 3.10.1998, p.1

[27]               13826/01

[28]               OJ L 142, 30.4.2004, p.1

[29]               2010/2153(INI)

[30]               12665/10

[31]
            OJ L 314, 1.12.2007, p. 9.

[32]             OJ
L 92, 30.3.2006, p.6

[33]             OJ
L 334, 12.12.2008, p.7

[34]             OJ L 281, 23.11.1995, p. 31

[35]             OJ L 8, 12.1.2001, p. 1.

[36]             OJ L 55, 28.2.2011, p.13

[37]             OJ L 248, 16.9.2002, p.1

[38]             OJ L 357, 31.12.2002, p.1

[39]             OJ L 31, 1.2.2002, p.1

[40]             OJ L
136, 30.4.2004, p. 1

[41]             OJ L
311, 28.11.2001, p. 67

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

[43]               ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.

[44]               As referred to in Article 49(6)(a) or (b) of the
Financial Regulation.

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

[46]               http://www.who.int/ihr/en/

[47]               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

[48]             Effectiveness = the extent to which options achieve the
objectives of the proposal

[49]             Efficiency/cost effectiveness = the extent to which
objectives can be achieved for a given level of resources/at least cost
(cost-effectiveness)

[50]             Coherence = the extent to which options are coherent
with the overarching objectives of EU policy, and the extent to which they are
likely to limit trade-offs across the economic, social and environmental domain

[51]             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.

[52]             See annex 1 for article 168 of the Lisbon Treaty

[53]             Measures include medical countermeasures (masks,
medicines) and containment of the event and decontamination (reduction or
removal of chemical agents from persons or places which have been contaminated)
A health measure will not address issues that are wider than public health and
hence will not include law enforcement or civil protection measures.

[54]             To
avoid confusing this committee with a committee as established under Article 3
of Regulation (EU) No 182/2011 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:055:0013:0018:EN:PDF)
it would be appropriate to change its name and avoid the term 'committee'.
Another name, such as 'EU High level Group for Health Security' may better
reflect the true nature of this body.

[55]             http://ecdc.europa.eu/en/healthtopics/pandemic_preparedness/pandemic_2009_evaluations
/Pages/pandemic_2009_evaluations.aspx provides an overview of all
evaluations on H1N1

[56]             Assessment Report on the EU-wide Response to Pandemic (H1N1) 2009
covering the period 24 April2009 – 31 August 2009: http://ec.europa.eu/health/communicable_diseases/docs/assessment_response_en.pdf;

[57]             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

[58]             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

[59]             HSC/EWRS
statement on School closures, 13 August 2009: http://ec.europa.eu/health/archive/ph_threats/com/influenza/docs/statement_school_en.pdf

[60]             http://ec.europa.eu/health/preparedness_response/docs/council_lessonsh1n1_en.pdf

[61]             Assessment report on EU wide pandemic vaccine
strategies of 25.8.2010 http://ec.europa.eu/health/communicable_diseases/docs/assessment_vaccine_en.pdf

[62]             http://ec.europa.eu/health/communicable_diseases/docs/assessment_vaccine_en.pdf

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

[64]             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.

[65]             http://ec.europa.eu/health/preparedness_response/docs/iridium_1_2011_frep_en.pdf

[66]             Health Strategy: COM(2007) 630
final - White paper - Together for Health: A Strategic Approach for the EU
2008-201; http://ec.europa.eu/health-eu/doc/whitepaper_en.pdf

[67]             EU 2020- EU Strategy for smart, sustainable and
inclusive growth; http://ec.europa.eu/europe2020/index_en.htm

[68]             See detailed information in annex 7

[69]             For further details, please see the "Inventory of
Crisis Management Capacities in Commission and Agencies"

[70]             http://ec.europa.eu/health/scientific_committees/policy/index_en.htm

[71]             http://ec.europa.eu/commission_2010-2014/malmstrom/archive/internal_security_strategy_in_action_en.pdf

[72]             http://www.europarl.europa.eu/meetdocs/2009_2014/documents/com/com_com(2009)0273_/com_com(2009)0273_en.pdf;

[73]             COM(2008) 130 final: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0130:FIN:EN:PDF

[74]             COM(2010) 600 final: http://ec.europa.eu/echo/civil_protection/civil/prote/pdfdocs/COM_2010_600_European_disaster_response_en.pdf

[75]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html

[76]             As referred to in Article 185 of the Financial
Regulation.

[77]             Diff. = Differentiated appropriations / Non-diff. =
Non-Differentiated Appropriations

[78]             EFTA: European Free Trade Association.

[79]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.

[80]             Year N is the year in which implementation of the
proposal/initiative starts. Depends on year of adoption of the Decision
(co-decision procedure).

[81]             For the first three years. Every three years, a
technical report on the activities of the Early Warning and Response System and
other activities carried out in the context of the implementation of this
Decision from the previous years will be forwarded to the European Parliament
and the Council.

[82]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[83]             Joint procurement of pandemic influenza vaccines
coordinated by DG SANCO

[84]             Year N is the year in which implementation of the
proposal/initiative starts.

[85]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.).

[86]             Only outputs at EU level are considered

[87]             Only outputs at EU level are considered

[88]             Only outputs at EU level are considered

[89]             As described in Section 1.4.2. "Specific
objective(s)..."

[90]             =(commitment year-1)*1.02

[91]             =(commitment year-1)*1.02

[92]             Year N is the year in which implementation of the
proposal/initiative starts.

[93]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[94]             CA= Contract Agent; INT= agency staff ("Intérimaire");
JED= "Jeune Expert en Délégation" (Young Experts in
Delegations); LA= Local Agent; SNE= Seconded National Expert;

[95]             Under
the ceiling for external personnel from operational
appropriations (former "BA" lines).

[96]             Essentially for Structural Funds, European Agricultural
Fund for Rural Development (EAFRD) and European Fisheries Fund (EFF).

[97]               See points 19 and 24 of the Interinstitutional
Agreement.

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