Dealing with serious cross-border threats to health in the EU : important steps taken but more needs to be done. Special report No 28, 2016.
Date: 2016-12-14
Institutions: European Court of Auditors
Subjects: EU Member State, European security, audit, health risk, public health, public safety, report, threat to national security

EN 

2016 

NO 28

Special Report  Dealing with serious 

cross-border threats to 
health in the EU: important 
steps taken but more 
needs to be done

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OF AUDITORS

 
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EN 

2016 

NO 28

Special Report

Dealing with serious  
cross-border threats to 
health in the EU: important 
steps taken but more 
needs to be done

(pursuant to Article 287(4), second subparagraph, TFEU)

Audit team

02

The ECA’s special reports set out the results of its performance and compliance audits of specific budgetary areas or 
management topics. The ECA selects and designs these audit tasks to be of maximum impact by considering the risks 
to performance or compliance, the level of income or spending involved, forthcoming developments and political and 
public interest.

This performance audit was produced by Audit Chamber I — headed by ECA Member Phil Wynn Owen — which special-
ises in sustainable use of natural resources. The audit was led by ECA Member Janusz Wojciechowski, supported by Kinga 
Wiśniewska-Danek, head of private office; Katarzyna Radecka-Moroz, private office attaché; Colm Friel, principal manager; 
Stefan den Engelsen, head of task, and Joanna Kokot, deputy head of task. The audit team consisted of Aris  
Konstant inidis, Jurgen Manjé, Roberto Resegotti and Frédéric Soblet. Language support was provided by Madis Rausi.

From left to right: C. Friel, A. Konstantinidis, K. Radecka-Moroz, S. den Engelsen, J. Wojciechowski,  
J. Manjé, J. Kokot, R. Resegotti, F. Soblet.

Contents

03

Paragraph

Abbreviations

I - X 

Executive summary

1 - 12 

Introduction

1 - 2 

Serious cross-border threats to health

3 - 12 

The EU framework for dealing with serious cross-border threats to health

13 - 20  Audit scope and approach

21 - 111  Audit observations

21 - 55 

The decision on serious cross-border threats to health introduced certain innovations for  
EU health security, but their implementation and development were hampered by delays and 
strategic and operational challenges remain

56 - 77 

The important role of existing systems and procedures for early warning and response and 
epidemiological surveillance is widely recognised but there are certain upgrades to be made

78 - 94 

The performance of the health programme as regards protecting citizens from health threats 
showed weaknesses

95 - 111  There are gaps in the Commission’s internal coordination in terms of health security activities and 

public health crisis management

112 - 121  Conclusions and recommendations

Annex I  —  Preparedness and response planning in the international context

Annex II  — 

 Description of main roles and responsibilities in the EU framework for protecting 
citizens against serious cross-border threats to health

Annex III  —  Overview of audited co-funded actions

Reply of the Commission

 
 
 
 
 
Abbreviations

04

AMR: antimicrobial resistance

Chafea: Consumer, Health, Agriculture and Food Executive Agency

DG ECHO: Directorate-General for European Civil Protection and Humanitarian Aid Operations

DG HOME: Directorate-General for Migration and Home Affairs

DG RTD: Directorate-General for Research and Innovation

EEA: European Economic Area

ECDC: European Centre for Disease Prevention and Control

ERCC: Emergency Response Coordination Centre

ERCEA: European Research Council Executive Agency

EWRS: early warning and response system

FP7: seventh framework programme for research

HEOF: Health Emergency Operations Facility

HSC: Health Security Committee

IHR: International Health Regulations (see Annex I)

MERS: Middle East respiratory syndrome

PHEIC: Public Health Emergency of International Concern

REA: Research Executive Agency

SARS: severe acute respiratory syndrome

SCHEER: Scientific Committee on Health, Environmental and Emerging Risks

SOP: standard operating procedure

STAR: strategic assessment and response

TESSy: The European Surveillance System

TFEU: Treaty on the Functioning of the European Union

WHO: World Health Organisation

Executive summary

05

I
In the previous decades, various events posing serious threats to health and life have led to increased attention 
for health security at the international and EU levels. Threats to public health can emerge from a range of differ-
ent origins. In addition to their health impact, they can cause very significant economic costs, in particular when 
an emergency lasts for a long time and disrupts travel and trade, and public life in general. Past events have also 
showed that serious health threats are often cross-border problems, and may require a multi-sectoral and multilat-
eral response.

II
The Treaty on the Functioning of the European Union (TFEU) states that a high level of human health protection 
shall be ensured and that Union action shall cover the monitoring, early warning of and combating of serious cross-
border threats to health. It specifies that EU action in the area of health is designed to support and complement 
actions of the Member States, which have the main responsibility for health policy. The Commission’s role in health 
policy therefore consists mainly of providing support and taking complementary action.

III
The European Union identified serious cross-border threats to health as an area where Member States can act more 
effectively together. It therefore developed coordination mechanisms to enable the Union to deal with such threats. 
A key milestone in building a stronger EU health security framework was the adoption in 2013 of a decision on seri -
ous cross-border threats to health, introducing important innovations as regards, for example, the coordination of 
preparedness planning and the strengthening of the role of the Health Security Committee (HSC). The EU health 
and research framework programmes also support activities in the field of health security.

IV
Implementing the decision on serious cross-border threats to health and the related framework is complex in view 
of the competences of the EU and the Member States, and the fact that serious threats keep emerging. We there-
fore assessed whether the EU framework for protecting citizens from serious-cross-border threats to health was 
adequately implemented. Under this main question we examined:

(1)  whether the innovations introduced by the decision are effectively implemented;

(2)  whether the existing systems for early warning and response and epidemiological surveillance are adequately 

managed and implemented;

(3)  whether the EU health programmes are making effective contributions to protecting citizens from threats to 

health;

(4)  whether the Commission’s internal coordination in terms of health security funding and public health crisis 

management is adequate.

Executive summary 

06

V
We concluded that Decision No 1082/2013/EU1 on serious cross-border threats to health represents an important 
step for dealing better with such threats in the EU. However, significant weaknesses at Member State and Commis-
sion level affect the implementation of the decision and the related EU framework. While the nature and scale of 
future threats is unknown and may evolve, more needs to be done to address these weaknesses for the Union to 
take full benefit from the established mechanisms.

VI
As regards the innovations introduced by the decision on serious cross-border threats to health, we found that their 
implementation and development were hampered by delays, potentially reducing their effective functioning. The 
coordination of preparedness planning was initiated but the relevant procedures need to be more robust and bet-
ter defined to deliver clear-cut results. The Member States have shown insufficient responsiveness to speed up the 
joint procurement of pandemic influenza vaccine, and there is not yet an EU mechanism to address urgent needs 
for medical countermeasures within the framework of the decision. The work and role of the HSC have proven to be 
very important, but it is facing strategic and operational challenges which need to be tackled, including in relation 
to the coordination of response rules.

VII
As regards the effective implementation of the existing systems for early warning and response and epidemio-
logical surveillance, we found overall that these systems have been operational for years and that their important 
role at EU level is widely recognised by stakeholders. However, there is scope for making certain upgrades to the 
Early Warning Response System (EWRS) and related procedures.

VIII
We concluded that the performance of the health programme as regards protecting citizens from health threats 
showed weaknesses. Most of the audited health threat actions from the second health programme (2008-2013), 
despite performing well in terms of producing the agreed deliverables, showed a lack of sustainable results, limit-
ing their contribution towards achieving the objective of protecting citizens from threats to health. We also found 
weaknesses in measuring the indicator for the health threats objective under the third health programme (2014-
2020) and a relatively low level of spending in 2014-2016.

IX
Finally, the audit revealed that a number of gaps existed in relation to the Commission’s internal coordination of 
health security activities across different services and programmes. We also found that more work needs to be done 
to make agreements for cooperation between Commission crisis management structures fully operational, and that 
DG Health and Food Safety’s management of its Health Emergencies Operations Facility showed weaknesses that 
might hamper its performance.

1  Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing 

Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Executive summary 

07

X
The Court makes a number of recommendations to address these observations:

(i) 

In order to speed up the development and implementation of the innovations introduced by the decision on 
serious cross-border threats to health, the Court makes recommendations covering a strategic HSC roadmap for 
the implementation of Decision No 1082/2013/EU; the performance monitoring of this policy area by the Com-
mission; the working methods of the HSC; and the joint procurement of medical countermeasures (see detailed 
Recommendation 1 (a) to (d), following paragraph 118).

(ii)  In order to further upgrade the EWRS and develop more integrated solutions for related risk management 

procedures, the Court makes recommendations on the development of the EWRS (see detailed Recommenda-
tion 2 (a) and (b), following paragraph 119).

(iii)  In order to address the main weaknesses identified in the performance of the health programme for actions 
addressing health threats, the Court makes recommendations on improving the sustainability of results from 
co-funded actions and the relevant performance measurement methodology (see detailed Recommendation 3 
(a) to (c), following paragraph 120).

(iv)  In order to bridge the gaps in the Commission’s internal coordination of activities relevant to health security 
and public health crisis management, and to improve the design of its Health Emergencies Operations Facil-
ity, the Court makes specific recommendations on a more structured coordination approach between services 
for health security activities, operationalising existing crisis management agreements and specific improve-
ments for the Health Emergencies Operations Facility (see detailed Recommendation 4 (a) to (c), following 
paragraph 121).

Introduction

08

Serious cross-border threats to health

01 
In the previous decades, deadly events such as the 2003 severe acute respiratory 
syndrome (SARS) epidemic, the worldwide H1N1 pandemic of 2009 and the 2011 
E. coli outbreak in Germany have led to increased attention being given at inter-
national and EU levels to health security. More recently, the worst Ebola outbreak 
ever in west Africa showed the serious implications for health and other sectors, 
not only in the affected regions, but also in countries across the world receiving 
travellers and patients from those regions. The outbreak clearly demonstrated 
the challenges which arise when a public health emergency is of a serious and 
cross-border nature (see Box 1).

1
x
o
B

The Ebola outbreak of 2014-2016

In March 2014 Guinea notified to WHO an outbreak of Ebola virus disease. On 8 August 2014, the Director-  
General of WHO declared the Ebola outbreak in west Africa a public health emergency of international 
concern (PHEIC — see Annex I for a description). This outbreak hit three countries directly (i.e. Guinea, Sierra 
Leone and Liberia) and was the worst ever epidemic of the disease with potentially more than 28 000 cases 
and 11 0002 deaths, including hundreds of healthcare workers.

The epidemic evolved into a public health, humanitarian and socioeconomic crisis with an unprecedented 
impact in affected countries3. It posed multi-sectoral challenges for the response action stretching far beyond 
the public health and healthcare sectors, involving a multitude of actors. Seven other countries (i.e. including 
Italy, Spain and the United Kingdom) later reported imported cases of Ebola4. This mainly concerned health-
care or aid workers returning or evacuated to their home country after having contracted the disease. The 
presence of many such foreign workers on the ground, including from Europe, posed additional challenges, 
in particular for organising medical evacuation and ensuring preparedness of healthcare facilities for treating 
cases of Ebola in European countries. The PHEIC for Ebola was terminated by the WHO Director-General on 
29 March 2016.

2  WHO Ebola Situation Report of 30 March 2016.

3  Council Conclusions on lessons learned for Public Health from the Ebola outbreak in west Africa — Health Security in the European Union 

(2015/C 421/04) of 17 December 2015.

4  WHO Ebola Situation Report of 30 March 2016.

 
Introduction 

02 
Serious cross-border threats to health are life-threatening or otherwise seri-
ous hazards to health of biological, chemical, environmental or unknown origin 
which may spread across the national borders of Member States, and which may 
necessitate coordination at Union level in order to ensure a high level of human 
health protection5 (see Box 2 for examples of such threats). In addition to the 
 human and health-related costs, serious threats to public health have the po-
tential to cause very significant economic costs, in particular when the outbreak 
lasts for a longer period of time and disrupts travel and trade, and potentially 
public life in general. These types of threats usually strike unexpectedly and 
might evolve rapidly into complex, large-scale emergencies. Health security 
policy and actions are therefore designed to protect citizens from such threats 
and avoid or mitigate severe impacts on society and the economy6.

09

5  Decision No 1082/2013/EU.

6 

See in particular 
considerations 1 to 3 of 
Decision No 1082/2013/EU.

2
x
o
B

Examples of serious cross-border threats to health

In October 2010, a major chemical incident occurred when liquid waste spilled from a caustic water reser-
voir of an alumina plant in Hungary. A wave of the sludge hit nearby localities causing deaths and injuries, 
with many people being treated for chemical burns. The toxic sludge eventually reached the Danube River 
prompting downstream countries to develop emergency response plans. Hungary also called upon the EU 
Civil Protection Mechanism for urgent international assistance.

The 2011 E.coli outbreak made 3 910 people ill and caused 46 deaths within 2 months. It led to overflowing 
intensive care units in Germany, shortages of medical equipment, extreme pressure on laboratory capacity 
and a lack of public confidence in health measures. This epidemic had a major impact on the agriculture sec-
tor in the EU. Losses for economic operators were estimated at hundreds of millions of euros, and compensa-
tion and aid schemes were put in place by the EU7.

Surveillance data show that antimicrobial resistance (AMR) is a growing public health problem in European 
hospitals and communities, mainly linked to the inappropriate use of antibiotics8. AMR threatens the effective 
prevention and treatment of an ever-increasing range of infections caused by bacteria, parasites, viruses and 
fungi9. According to WHO, AMR is an increasingly serious threat to global public health that requires ac-
tion across all government sectors and society as new resistance mechanisms emerge and spread globally.

7 

SEC(2011) 1519 final of 8 December 2011 ‘Impact Assessment accompanying the document Decision of the European Parliament and of the 
Council on serious cross-border threats to health’.

8 

ECDC Factsheet for the general public on antimicrobial resistance (http://ecdc.europa.eu).

9  WHO Factsheet No 194 on antimicrobial resistance, updated April 2015.

 
10

10  See Article 168(1) of the Treaty 
on the Functioning of the 
European Union.

11  Also see Chapter 1 of the 
white paper ‘Together for 
Health: A Strategic Approach 
for the EU 2008-2013’, 
COM(2007) 630 final of 
23 December 2007.

12  COM(2007) 630 final.

13  The other two are fostering 
good health in an ageing 
Europe, and supporting 
dynamic health systems and 
new technologies.

14 

15 

‘Health Security in the 
European Union and 
internationally’, SEC(2009) 
1622 final of 
23 Novem     ber 2009.

‘EU’s Internal Security Strategy 
in Action: Five steps towards 
a more secure Europe’, 
COM(2010) 673 final of 
22 October 2010.

16  Decision No 2119/98/EC of the 
European Parliament and of 
the Council of 24 Septem-
ber 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).

17  Article 1, paragraph 1 of 

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 (ECDC 
founding regulation) (OJ L 142, 
30.4.2004, p. 1).

Introduction 

The EU framework for dealing with serious cross-
border threats to health

EU public health strategy

03 
The Treaty on the Functioning of the European Union (TFEU) includes provisions 
on health and provides10, among other things, that a high level of human health 
protection shall be ensured in the definition and implementation of all Union 
policies and activities and that Union action shall cover the monitoring, early 
warning of and combating serious cross-border threats to health. It also specifies 
that EU action in the area of public health is designed to support and comple-
ment actions of the Member States, which hold the main responsibility for health 
policy11. The Commission’s role in health policy therefore mainly consists of pro-
viding support and taking complementary action where needed.

04 
One of the three objectives of the EU health strategy for 2008-201312 was to pro-
tect people from health threats13. According to the Commission’s 2011 mid-term 
evaluation of the health strategy, the objectives and principles of the health strat-
egy were consistent with Europe 2020, by promoting health as an integral part 
of the smart and inclusive growth objectives. It therefore remained valid towards 
2020. Other relevant Commission publications on EU health security14 and the 
wider area of internal security15 referred to the fact that these health threats are 
often cross-border problems with an international impact. According to these 
strategies, Member States cannot effectively respond to such threats alone, pro-
viding a basis for Union action in this field.

Mechanisms and tools for EU-wide coordination and 
international cooperation

05 
The Council of Health Ministers had already established in 2001 an informal 
Health Security Committee (HSC), as one of the mechanisms to coordinate 
Member State actions in response to health security issues. At that time, the main 
EU legislation to protect citizens from health threats concerned communicable 
diseases. Decision No 2119/98/EC16 set up a network for the epidemiological 
surveillance and control of communicable diseases in the Community, including 
an early warning and response system (EWRS). In 2004, the European Centre for 
Disease Prevention and Control (ECDC), an independent European agency17, was 
founded. It started working in 2005 and took on the hosting and coordination of 
the epidemiological surveillance network and the EWRS.

Introduction 

11

06 
At international level, the Commission collaborates with the Global Health Se-
curity Initiative18 and WHO. WHO coordinates the implementation of the Inter-
national Health Regulations 2005 (see Annex I for more detailed information on 
the International Health Regulations (IHR)), a legally binding treaty in force since 
2007, adopted in the context of the growth in international travel and trade, and 
the emergence and re-emergence of international disease threats and other 
public health risks (see Table 1 for an overview of major threats since the adop-
tion of the IHR). All EU Member States are State Parties to the IHR and need to 
develop, strengthen and maintain core public health capacities for surveillance 
and response. They also report to WHO on IHR implementation.

18  This G7 initiative was launched 
in November 2001 by Canada, 
the EU, France, Germany, Italy, 
Japan, Mexico, the United 
Kingdom and the United 
States. WHO serves as an 
expert adviser to the GHSI and 
the Commission participates 
in the GHSI as the EU’s 
representative.

1
e
l
b
a
T

Major disease outbreaks since the entry into force of the IHR 2005

Year

2009

2012

Major disease outbreaks

Health impact

H1N1 influenza pandemic (or 'swine flu')

18 449 deaths in more than 214 countries and ter-
ritories or communities (as per 1 August 2010).

Middle East respiratory syndrome coronavirus 
(MERS-CoV)

1 769 confirmed cases in 27 different countries and 
630 deaths reported since September 2012.

2013

Avian influenza H7N9 in human beings

Case fatality rate approximately 25 %. Previous cases 
of other subgroups of H7 avian influenza reported in 
multiple countries in earlier years.

2014

2014

2016

Resurgence of polio after it had nearly been 
eradicated

In 1988 there were 350 000 cases in 125 countries; in 
2015 74 cases in 2 countries.

Ebola outbreak in west Africa

Zika virus outbreak

More than 28 000 cases confirmed in Guinea, Liberia 
and Sierra Leone and more than 11 000 deaths.

As of June 2016: 61 countries reporting ongoing 
mosquito-borne transmission. 

PHEIC declaration 
by WHO

April 2009

N.A.

N.A.

May 2014

August 2014

February 2016

Source: WHO Fact Sheets and thematic websites on the relevant diseases as per July 2016.

 
Introduction 

12

Decision No 1082/2013/EU on serious cross-border threats to 
health

19  Decision No 1082/2013/EU.

07 
In an effort to coordinate Member State actions relevant to health security in 
the Union, Decision No 1082/2013/EU on serious cross-border threats to health19 
was adopted. It introduces the concept of an ‘all hazards approach’ (i.e. similar to 
the IHR) in the European legislation and puts certain obligations on the Member 
States and the Commission for cooperation and coordination in specific areas 
(see Figure 1).

1 Main areas of Decision No 1082/2013/EU on serious cross-border threats to health
e
r
u
g
i
F

Decision No 1082/2013/EU
Serious cross-border threats to health

Origins of threats

Biological1

Chemical

Environmental

Unknown ?

EU level

Main areas

National level

Comission
DG Sante
“Coordinate + Support” 
Art.168 TFEU

ECDC/2004
“Communicable diseases”

Other EU
agencies/bodies

Preparedness

Joint procurement 

Surveillance/monitoring

EWRS

Risk assessment

Coordination of response

Emergency declaration

Member
States 

General competence
for public health

Health Security Comittee

HSC members

Competent body for surveillance

National bodies

EWRS contact point

1 Biological threats can be communicable diseases, antimicrobial
  resistance and special health issues, and biotoxines

.

Source: European Court of Auditors.

 
 
Introduction 

13

08 
The decision should enable the EU to better address risks related to serious cross-
border threats to health. Its innovations in EU legislation include the formalisa-
tion and strengthening of the role of the HSC and rules on response coordination; 
extension of the EU legal framework to also cover threats other than communic-
able diseases (notably chemical and environmental threats and threats from un-
known origin, but also antimicrobial resistance and bio-toxins); consultation on 
and coordination of preparedness planning; and a new legal basis for the already 
existing Early Warning and Response System and epidemiological surveillance 
network.

20  The Joint Procurement 

Agreement was initially signed 
by 15 Member States in 
June 2014 and entered into 
force on 5 July 2014. As per 
May 2016, 24 EU Member 
States had signed this 
agreement.

09 
Another innovation of the decision is the joint procurement of medical counter-
measures (e.g. vaccinations), which provides that if a Joint Procurement Agree-
ment (JPA) is signed20, specific joint procurements of medical countermeasures 
can be organised. The decision also provides that the Commission may declare an 
EU emergency situation (see Annex I).

Main roles and responsibilities in implementing the EU 
framework

10 
As stated in paragraph 3, the main responsibility for health policy lies with the 
Member States. Additionally, the decision on serious cross-border threats to 
health puts a number of specific obligations on Member States for the areas 
described in paragraphs 7 to 9, including to nominate certain bodies and repre-
sentatives for EU-level coordination structures. The Commission (i.e. in particular 
DG Health and Food Safety) is responsible for the implementation and develop-
ment of the relevant parts of the EU health strategy and policy. It also has specific 
responsibilities under the decision, including providing the secretariat and 
presidency of the HSC, and operates its Health Emergency Operations Facility. 
The European Centre for Disease Control and Prevention operates the network 
for epidemiological surveillance of communicable diseases and the Early Warning 
and Response System (for a more detailed description of these responsibilities, 
see Annex II).

Introduction 

14

EU co-funded actions in the area of threats to public health

EU health programmes

11 
The EU’s health strategy is supported by multiannual health programmes. The 
second programme ran from 2008 to 2013 21. The third programme is being im-
plemented in the period 2014 to 2020 22. The Consumer, Health, Agriculture and 
Food Executive Agency (Chafea) is largely responsible for the management of 
the health programme. Objective 2 of the 2014-2020 health programme, which is 
relevant to our audit, is aligned with the activities and definitions of the decision 
on serious cross-border threats to health. Table 2 provides an overview of the 
relevant objectives and spending or budget.

21  Established by Decision 
No 1350/2007/EC of the 
European Parliament and of 
the Council of 
23 October 2007 establishing 
a second programme of 
Community action in the field 
of health (2008-13) (OJ L 301, 
20.11.2007, p. 3).

22  Established by Regulation (EU) 
No 282/2014 of the European 
Parliament and of the Council 
of 11 March 2014 on the 
establishment of a third 
Programme for the Union’s 
action in the field of health 
(2014-2020) and repealing 
Decision No 1350/2007/EC 
(OJ L 86, 21.3.2014, p. 1).

2 Health programme objectives relevant to this audit1
e
l
b
a
T

Second health programme 2008-2013

Third health programme 2014-2020

Total operational budget for the 
period

247 million euro

Number of main objectives

Sub-actions/priorities

3

19

Relevant strand for this audit

1: Improve citizens’ health security 
1.1: Protect citizens against health threats

Spending/budget for this strand

32 million euro for Action 1.1 (approximately 13 %)

405 million euro

4

23

2: In order to protect Union citizens from serious 
cross-border health threats: identify and develop 
coherent approaches and promote their implemen-
tation for better preparedness and coordination in 
health emergencies.

Estimated 12 million euro based on the 2013 multi-
annual planning for 2014-2016 (approximately 3 %).

1 

 In relation to the figures presented in Table 2 it should be noted that these are not entirely comparable between the programming periods 
due to different sub-priorities and a shift of certain activities from the health programme to ECDC, which has a considerable annual budget of 
approximately 55 million euro.

Source: ECA, based on information provided by the Commission.

 
Introduction 

15

Other EU funding for health security

12 
Other EU funds, in particular the research framework programmes (FP7 in 2007-
2013 and Horizon 2020 for 2014-2020), also provide funding for actions related to 
health security. The thematic areas ‘Health’ and ‘Security’ under the FP7 coopera-
tion programme invested more than 7 billion euro 23. DG Research and Innovation 
and DG Migration and Home Affairs are the directorates-general in charge of this 
thematic areas. The new Horizon 2020 programme also addresses health and 
security research24. It is estimated25 that during 2014-2020 the EU will invest some 
9.1 billion euro in these areas. For health this includes the objective of enhancing 
the ability to monitor health and to prevent, detect, treat and manage disease. 
Grants awarded under these programmes might therefore be directly relevant to 
health security policy and dealing with serious cross-border threats to health26.

23  See FP7 budget execution 
figures for 2007-2013 on 
https://ec.europa.eu/research/
fp7/index_en.cfm?pg=budget

24  Under Societal Challenges 1 

‘Health, demographic change 
and wellbeing’ and 7 ‘Secure 
societies’.

25  See Factsheet  on Horizon 

2020 budget of 
25 Novem ber 2013.

26  For example projects covering 
topics such as Ebola, AMR and 
communicable diseases, and 
also preparedness.

Audit scope and approach

16

13 
In defining the audit scope and objectives, we considered the EU framework for 
protecting citizens from serious cross-border threats to health to consist mainly 
of Decision No 1082/2013/EU on serious cross-border threats to health and the EU 
resources made available to support its implementation. Overall, this framework 
fits into the wider context of the EU health strategy.

14 
The audit work addressed the following main audit question:

Is the EU framework for protecting citizens from serious cross-border threats 
to health adequately implemented?

Under this main question we examined:

(i)  whether the innovations introduced by the decision are effectively 

implemented;

(ii)  whether the existing systems for early warning and response and epidemio-

logical surveillance are adequately managed and implemented;

(iii)  whether the EU health programmes are making effective contributions to 

protecting citizens from threats to health; and

(iv)  whether the Commission’s internal coordination in terms of health security 

funding and public health crisis management is adequate.

15 
The scope of the audit is closely aligned with the various areas of the decision on 
serious cross-border threats to health (also see Figure 1 above). Sub-question 1 
covered the innovations introduced in EU legislation by the decision (e.g. coordi-
nation of preparedness planning, joint procurement and the strengthened role 
of the HSC, see paragraphs 7 to 9), and sub-question 2 covered the systems that 
already existed previously (i.e. for epidemiological surveillance and early warning 
and response).

16 
The audit scope also included an assessment of the management of EU resources 
made available to contribute to protecting citizens from health threats. Under 
sub-question 3 we assessed relevant actions and projects by DG Health and Food 
Safety and Chafea for the 2008-2013 and, to a certain extent, 2014-2020 program-
ming periods.

Audit scope and approach 

17

27 

28 

In this context we also refer to 
another performance audit by 
the Court on Commission 
crisis management in the 
external domain, including 
a case study of the Ebola crisis.

Information visits were made 
to Estonia, Italy, the 
Netherlands and the United 
Kingdom. We selected these 
countries based on 
geographical spread and risk 
factors such as travel, trade 
and external borders.

29  Representing approximately 
56 % (i.e. 18 million euro) of 
the health threats funding 
under the second health 
programme. We also visited 
the main coordinators of 
seven projects on the spot.

17 
Under sub-question 4 we assessed general performance and coordination ac-
tivities, notably at the level of DG Health and Food Safety’s Crisis Management 
and Preparedness in Health Unit and ECDC’s relevant operational units. We also 
looked into DG Health and Food Safety’s coordination with other Commission 
services, especially in relation to research programmes with health security ob-
jectives, as well as to crisis management structures.

18 
The Court does not have the mandate to examine the implementation of the 
WHO IHR by the Member States or the general implementation of preparedness 
plans at national level. This was therefore not part of the audit scope. However, 
certain IHR concepts were considered during the audit. As regards our audit work 
on the coordination of crisis management structures the audit scope did not 
include a full assessment of their functioning across multiple directorates-general 
or as part of the EU response to the Ebola outbreak27.

19 
Questions 1 to 4 were addressed at the level of the Commission (i.e. DG Health 
and Food Safety, and for questions 3 and 4 information visits were also made 
to DG Migration and Home Affairs, DG Research and Innovation, the Research 
Executive Agency (REA) and the European Research Council Executive Agency 
 (ERCEA)) and ECDC, and discussed during information visits to four Member 
States28. In addition to interviews during the site visits, we conducted an informa-
tion visit to WHO Europe, performed a desk review of 20 health programme ac-
tions29 (see Annex III for an overview of these) and the objectives of ten FP7 pro-
jects (see Annex III) and consulted Commission progress and implementation 
reports, as well as documents relating to the work of the HSC.

20 
The materiality and potential impact relevant to the implementation and man-
agement of the areas included in the audit scope should mainly be judged by the 
potential costs and consequences of not dealing with cross-border public health 
threats in the most effective way. Emergency situations typically require the im-
mediate availability of significant (financial) resources for response actions, and 
all the more so if the early response is slower or less effective than required. In 
addition, damaging impacts are not restricted to human health, but also poten-
tially extend to many sectors of the wider economy, as described in paragraphs 1 
and 2. Given the unpredictable nature and scale of future public health emergen-
cies it is not possible to quantify such damages and impacts up front.

Audit observations

18

The decision on serious cross-border threats to health 
introduced certain innovations for EU health security, 
but their implementation and development were 
hampered by delays, and strategic and operational 
challenges remain

30  Article 4 of Decision 
No 1082/2013/EU.

21 
We examined whether the innovations introduced by the decision on serious 
cross-border threats to health, as described in paragraphs 7 to 9 and  Figure 1, 
were effectively implemented. Overall we found that the implementation and 
development of these innovations were hampered by delays, and that strategic 
and operational challenges remain. In the following paragraphs we report on 
insufficiently clear-cut results from the preparedness planning consultation and 
coordination and the weak measurement of performance for these activities. We 
also report on ECDC’s role in generic preparedness, which is not sufficiently for-
malised, the slow progress in joint procurement of medical countermeasures and 
the absence of an EU mechanism to address urgent needs for medical counter-
measures within the framework of the decision on serious cross-border threats to 
health. Finally, we report on operational and strategic challenges for the Health 
Security Committee and difficulties in applying the coordination of response 
rules.

Insufficient clear-cut results from the preparedness planning 
consultation and coordination

22 
Member States and the Commission should consult each other within the HSC 
with a view to coordinating their efforts to develop, strengthen and maintain 
their capacities for the monitoring, early warning and assessment of, and re-
sponse to, serious cross-border threats to health30. That consultation should be 
aimed at sharing best practices and experience in preparedness and response 
planning, promoting the interoperability of national preparedness planning and 
addressing the need for different sectors (e.g. health, civil protection, transport, 
border control) to work together in preparedness and response planning at 
Union level. It should also support the implementation of core capacity require-
ments for surveillance and response as referred to in the IHR (see Annex I).

23 
Member States should submit to the Commission by 7 November 2014, and every 
3 years thereafter, an update on the latest situation with regard to their national 
preparedness and response planning for the main areas described above. To en-
sure compatibility and relevance of the information to the objectives, the submis-
sion of this information is based on a template adopted by the Commission.

Audit observations 

19

31  WHO (2014), Summary of State 
Parties 2013 report on IHR core 
capacity implementation, 
Regional Profiles; http://www.
who.int/ihr/publications/
WHO_HSE_GCR_2014.10/en/

24 
The Commission, in consultation with the Member States, adopted the template 
for providing the preparedness information in July 2014, only 4 months before 
the deadline for completion of the questionnaire by the Member States, during 
the Ebola crisis. Nine Member States submitted their replies on time through an 
electronic survey. A further 17 Member States submitted their replies late, mostly 
in 2015, after the Commission had reminded them several times. The Commission 
worked with ECDC and WHO Europe to compile a progress report on prepared-
ness and response planning based on the Member State replies, which was put 
to the HSC in June and November 2015. Despite the delays in submitting the 
replies, this initiated the required exchange of information on preparedness and 
response planning.

25 
However, most of the information included in this report, apart from some 
geographical maps sourced from WHO reports31, is anonymised and aggregated. 
It therefore does not show members of the HSC which country provided which 
information, suggestions for improvements or best practices, or examples, to 
allow for efficient and transparent exchanges of views, despite the confidential 
character of the HSC and the report itself. Neither the decision on serious cross-
border threats to health nor the template for the questionnaire require Member 
States to provide supporting evidence such as implementation or action plans, 
national manuals or actual preparedness plans.

26 
The legislation does not provide the Commission with the mandate to collect or 
verify such information, for example during country visits. The information in-
cluded in the progress report on relevant aspects of preparedness is solely based 
on self-assessments by the Member States and does not contain supporting evi-
dence. Although this does not mean that the reported information is in accurate, 
the consequence is that strengths and weaknesses identified in the report and 
presented to the HSC are not based on data that was externally verified or re-
viewed. Such reviewing and increased transparency, while not foreseen by the 
legislation, are likely to contribute to a higher level of confidence in relation to 
preparedness for serious cross-border health threats (see Box 3 on weaknesses 
in self-assessment in relation to IHR implementation), and would allow for better 
targeting of actions needed to address weaknesses.

Audit observations 

20

3
x
o
B

International developments concerning preparedness: weaknesses in self-
assessment of IHR implementation

Weaknesses inherent in self-assessments on IHR core capacity implementation have been signalled by WHO 
and its expert panels. The Ebola Interim Assessment Panel wrote in July 2015 that it considered it to be unac-
ceptable that only voluntary self-assessment is required for the measurement of IHR core capacities. It referred 
to encouraging efforts, both within WHO and through initiatives such as the Global Health Security Agenda 
(see Annex I describing other initiatives addressing the need to enhance preparedness planning and increase 
transparency), to promote evaluation frameworks, external monitoring and transparency about core 
capacities and underlined that regional political agencies, such as the European Union can support this work.

The 69th World Health Assembly (23 to 28 May 2016) considered the report of the Review Committee on the 
role of the IHR in the Ebola outbreak and response and arrived at a similar conclusion. The Review Committee 
identified a lack of implementation of the IHR as contributing to the escalation of the Ebola outbreak. The ap-
proaches proposed by the Review Committee to strengthen implementation of the IHR include recognition 
of external assessment of country core capacities as a best practice.

27 
Some Member States, despite their involvement in developing the template, 
found it difficult in practice to reply to the preparedness questionnaire and 
therefore had some reservations about findings in the progress report. In addi-
tion, the technical implementation of the questionnaire through the online sur-
vey showed weaknesses limiting the data quality for certain questions. This was 
in part due to the fact that ECDC was not involved sufficiently early by DG Health 
and Food Safety in the IT preparations for using the online survey tool.

32  Article 4 of Decision 
No 1082/2013/EU.

33  Page 17 of SEC(2011) 1519 final 

of 8 December 2011.

34 

‘Strategy for Generic 
Preparedness Planning, 
Technical guidance on generic 
preparedness planning for 
public health emergencies’ 
(Update 2011).

28 
As regards any potential EU criteria for preparedness and response planning, on 
top of the basic criteria in the decision32, the Commission, in its 2011 Impact As-
sessment33, referred to the availability of extensive guidance on generic prepar-
edness planning34 for all types of health threats, and the fact that there was no 
mechanism in place to ensure its implementation in all Member States. We found 
that this guidance was not given any status under the framework of the decision 
on serious cross-border threats to health and that awareness about its content 
is generally low, despite significant efforts made by the Commission and several 
Member States to produce the comprehensive, updated version of 2011 and the 
translations available on the Commission’s website. If the guide is not used by 
the Member States, or kept up to date, this significant investment of resources is 
potentially lost.

 
21

35  Specific, measurable, 

achievable, relevant and 
time-bound.

36  The same objective and 

indicator are also provided in 
Articles 2 and 3 of Regulation 
(EU) No 282/2014 to measure 
the performance of the 
relevant spending under this 
objective.

Audit observations 

29 
Overall we found that the consultation between Member States and the Com-
mission on preparedness and response planning has been initiated as required. 
However, the procedures for obtaining and exchanging relevant information with 
a view to better coordinating efforts in relation to preparedness are not yet suf-
ficiently robust and have not yet delivered clear-cut results.

Weak measurement of performance in preparedness 
coordination

30 
The Commission should measure the effectiveness of Union policies and pro-
grammes. This also applies to the EU policy objectives of the decision on serious 
cross-border threats to health, and in particular the efforts made under Article 4 
on preparedness and response planning referred to above. SMART35 objectives 
and indicators therefore need to be defined, in close contact with the Member 
States, and a methodology to enable a clear progress measurement and evalua -
tion. Member States in turn then need to demonstrate their progress.

31 
DG Health and Food Safety’s objectives for health in the current programming 
period (2014-2020) include a specific objective related to the protection of citi-
zens from serious cross-border health threats: to identify and develop coherent 
approaches and promote their implementation for better preparedness and co-
ordination in health emergencies. The related specific result indicator is: ‘Number 
of Member States integrating the developed common approaches in the design 
of their preparedness plans […]’36.

32 
For this specific objective and indicator, the Commission, in its management 
plans for 2014 and 2015, set the targets at four Member States integrating the 
developed common approaches in the design of their preparedness plans by 
2015, 14 by 2017 and all Member States by 2020. However, the objective and 
indicator are not included as such in the decision, meaning that Member States 
are not bound by them. It also does not provide criteria on what constitute inte-
grated common approaches in the design of preparedness plans, which, accord-
ing to the objective would still have to be identified and developed. We found 
that when the Commission set the indicator targets, neither was this concept of 
common approaches further developed by the Commission in agreement with 
the Member States, nor was there a clear and agreed approach to measuring 
progress.

22

37  As acknowledged by 

DG Health and Food Safety in 
its Annual Activity 
Report 2015, where it reports 
on progress for this specific 
objective and indicator.

Audit observations 

33 
Early in 2016, the Commission refined its methodology to measure the progress 
under the specific indicator and requested ECDC to perform further analysis on 
the data received from Member States. ECDC was asked to measure the number 
of Member States that had in place the elements of IHR core capacity implemen-
tation, interoperability arrangements between sectors and business continuity 
plans. ECDC concluded that 16 Member States declared that they had these ele-
ments in place and that the indicator for 2015 was therefore ahead of target (i.e. 
14 by 2017). However, as illustrated in paragraph 32, we could not confirm that 
this methodology was discussed with and endorsed by the HSC.

34 
We were therefore unable to conclude what the reported progress means in 
terms of performance and whether all definitions and concepts of the objectives, 
indicators and targets are supported by the Member States. This is especially 
important as the effective coordination of preparedness and response planning 
for serious cross-border threats largely depends on them37, and requires stake-
holders to work towards the same objectives.

ECDC’s role in relation to generic preparedness is 
insufficiently formalised

35 
ECDC has a mandate to support Member States and the Commission in pre-
paredness activities. ECDC’s mandate was traditionally for disease prevention 
and control and has not been formally updated since its establishment, despite 
important health security developments, in particular the entry into force of the 
IHR and the adoption of the decision on serious cross-border threats to health. 
We therefore examined whether it was sufficiently clear between the Commis-
sion and ECDC, as well as vis-à-vis ECDC’s stakeholders, to what extent ECDC can 
provide expertise in the area of generic preparedness and how it should plan its 
activities and resources for this purpose.

36 
ECDC’s founding regulation states that it can provide scientific and technical 
expertise to the Member States, the Commission and other Community agencies 
in the development, regular review and updating of preparedness plans, and also 
in the development of intervention strategies in the fields within its mission (i.e. 
protection from infectious diseases and threats of unknown origin). The decision 
on serious cross-border threats to health specifically attributes tasks to ECDC for 
epidemiological surveillance and early warning and response, but not for support 
on preparedness planning.

Audit observations 

23

38  One of these tasks was the 

assistance provided by ECDC 
to the Commission in 
aggregating the data 
submitted by Member States 
under Article 4 of Decision 
No 1082/2013/EU and 
reporting to the HSC.

39  Council conclusions on 
Pandemic (H1N1) 2009 – 
a strategic approach, 
paragraph 11, p. 2.

40  Key changes to pandemic 

plans by Member States of the 
WHO European Region based 
on lessons learnt from the 
2009 pandemic, WHO 
Regional Office for Europe and 
ECDC, 2012.

41  Guide for influenza pandemic 
plan revision — Applying the 
lessons learned from the 
pandemic H1N1(2009): A guide 
for the Member States of the 
WHO European Region, 
European Union and 
European Economic Area, 
draft of 2014.

37 
Following the adoption of the decision on serious cross-border threats to health, 
ECDC has been working on new tasks38, especially in the area of generic pre-
paredness, addressing the need for the EU to have an all-hazards approach. How-
ever, we found that ECDC’s role and responsibilities in relation to generic pre-
paredness were not formally defined and agreed, either through updates of the 
relevant legislation or, for example, in a written agreement between the Commis-
sion and ECDC, endorsed by ECDC’s stakeholders. If there is insufficient formal 
clarity on ECDC’s role in these activities and how they fit its mission, the organi-
sation may not be able to properly prepare itself for such tasks in the long term, 
nor to respond effectively to requests for assistance. The risk stemming from this 
situation has already materialised in relation to joint work done by ECDC and 
WHO on a guide for influenza pandemic plan revision, as illustrated below.

38 
After the pandemic influenza of 2009 one of the Council’s main recommenda-
tions was the adoption of guidance on preparedness plans39. Countries across 
Europe started revising their pandemic plans based on the lessons learned. ECDC 
and WHO Europe made a substantial effort in organising workshops and review 
work. They published a joint document in 2012 listing the outcomes of this exer-
cise40. Subsequently, they worked on a ‘Guide for influenza pandemic plan revi-
sion’41. The drafted guide was addressed to all 53 countries in the WHO European 
region and was developed by experts in pandemic preparedness planning from 
various countries and organisations.

39 
However, the Commission put on hold the publication of the guide by ECDC in 
March 2014, invoking doubts as regards ECDC’s mandate to issue this type of 
guidance directly to the Member States and concluding that the HSC is the ap-
propriate and mandated body to discuss matters of preparedness. At the time of 
the audit (2 years later) the timelines for discussion of the guide by the HSC (or its 
preparedness working group) and its publication were not known. Not publish-
ing and promoting this guide would constitute a lost investment in terms of the 
resources and efforts engaged for its production and means that EU Member 
States and WHO Europe countries had no access to it even when efforts were 
made at national level to update pandemic preparedness plans.

Audit observations 

24

42  Council conclusions of 

13 September 2010 on lessons 
learned from the A/H1N1 
pandemic — health security in 
the European Union.

43  See ECDC Rapid Risk 
Assessment ‘A case of 
diphtheria in Spain’ of 
15 June 2015: ‘The detection, 
management and public 
health response to the first 
case of diphtheria in Spain in 
nearly 30 years has 
highlighted challenges for 
preparedness against 
diphtheria in the European 
Union.’

Insufficient Member State responsiveness to speed up 
the joint procurement of pandemic influenza vaccine and 
absence of an EU mechanism to address urgent needs for 
medical countermeasures within the framework of the 
decision on serious cross-border threats to health

40 
Following the H1N1 influenza pandemic crisis in 2009, the Council42 invited the 
Commission to report on and develop, as soon as possible and no later than De-
cember 2010, a mechanism for joint procurement of vaccines and antiviral medi -
cation. Already in 2011, the Commission had invited Member States to provide 
needs analyses in relation to such a joint procurement procedure. However, it 
was not until 2013, through the adoption of the decision on serious cross- border 
threats to health, that there was an EU legal basis for the joint procurement of 
medical countermeasures. The Commission adopted the Joint Procurement 
Agreement on 10 April 2014. Countries which have signed the Joint Procurement 
Agreement can participate in specific joint procurement procedures for medical 
countermeasures, which require a minimum of four Member States.

41 
In February 2016, the Commission successfully finalised and published the speci-
fications for the joint procurement of personal protective equipment, initiated in 
the wake of the Ebola crisis. In addition, several other specific joint procurement 
procedures have been started. However, preparation of the specific joint procure-
ment procedure for pandemic influenza vaccine, initially requested by the Coun-
cil in 2010, was still ongoing. Despite various requests sent by the Commission 
only five Member State needs assessments had been received by April 2016. Fu-
ture progress depends on the Member States’ commitment to these pro cedures. 
The Commission reported in its Annual Activity Reports for 2014 and 2015 that 
the targets for joint procurement of pandemic influenza vaccine had not been 
met.

42 
An emergency instrument to address urgent needs of medical countermeasures 
would require less complexity and provide higher speed and greater flexibility 
than the joint procurement agreement provides. Following a case of diphtheria 
in Spain in 2015, when the treating hospital struggled to get antitoxin in Europe43, 
the HSC and the Commission decided to look into potential solutions to ad-
dress such cases in the future. The HSC agreed to task its preparedness working 
group with the development of standard operating procedures for a rapid and 
consistent Union response in such emergencies. In January 2016, the Commis-
sion requested Member States to nominate participants in the HSC preparedness 
group on a standard operating procedure for exchanging medical countermeas-
ures. However, during the audit we could not obtain evidence that the relevant 
procedure had been agreed or that specific work had been initiated (also see 
paragraphs 46 and 47).

Audit observations 

25

43 
Overall, as regards the implementation of the joint procurement provisions, we 
found that progress in organising the joint procurement of pandemic influenza 
vaccine, initiated after the 2009 H1N1 pandemic, had been slow by the time of 
our audit due to low Member State responsiveness and that there is no mech-
anism at EU level to address urgent needs for medical countermeasures, poten-
tially reducing the EU’s preparedness for pandemic influenza.

Strategic and operational challenges for the formalised 
Health Security Committee

44 
The decision on serious cross-border threats to health establishes the HSC, com-
posed of representatives from the Member States, and chaired by the Commis-
sion (see Annex II for a more detailed description of its role and responsibilities).

45 
All Member States have nominated their members of the HSC. Plenary meetings 
took place once in 2014 and three times in 2015, as well as a large number of 
 audioconferences, in particular in relation to the evolving Ebola crisis (see Box 4).

4
x
o
B

The Health Security Committee and the Ebola outbreak

Discussions about Ebola started in the HSC in March 2014, after the initial notification of the outbreak by 
Guinea to WHO and the issuance of a rapid risk assessment by ECDC. According to this rapid risk assessment, 
the risk of transmission to the EU was low, although certain situations could justify measures in the EU, such as 
tourists returning from Guinea visiting family and friends or exposed persons seeking medical attention in the 
EU.

The Ebola outbreak was declared a PHEIC by WHO on 8 August 2014. A week earlier, the Commission had 
called an HSC audioconference meeting in view of the quickly deteriorating circumstances in the affected 
countries. Many different Commission services, ECDC, WHO and the Member States attended. The objective 
was to exchange information and coordinate actions on measures being taken and planned, to identify ad-
ditional actions to strengthen preparedness and to consider assistance to affected countries. Options for the 
medical evacuation of EU/EEA citizens working in them were also discussed. DG Health and Food Safety, with 
assistance from ECDC, had drafted a questionnaire on Ebola preparedness (i.e. to obtain an overview of labo-
ratories capacities, hospital facilities for Ebola, suitable transport), which was sent out to the Member States 
and answered by most of them. After the declaration of the PHEIC by WHO, the frequency of HSC meetings 
dedicated to Ebola increased significantly (almost weekly until January 2015). Only from February 2015, did 
operational topics return to the HSC agenda, such as joint procurement and the working groups.

 
Audit observations 

26

46 
At the time of our audit, the terms of reference had been drafted for four work-
ing groups under the HSC: a permanent working group on preparedness, a per-
manent communicators’ network, an ad hoc working group on newly arrived 
migrants and communicable diseases, and an ad hoc working group on combat-
ing antimicrobial resistance (AMR) (see Box 2). However, the HSC only formally 
established the communicators’ network and preparedness working group. 
Based on their terms of reference, these working groups were to prepare an an-
nual work plan, including performance indicators for evaluation, to be submitted 
and approved by the HSC, to ensure a structured way of working on these topics. 
We found that at the end of the audit (March 2016) no annual work plans with the 
indicators required under the working groups’ terms or reference had been sub-
mitted for approval to the HSC. This means that the work done by these working 
groups is not implemented in accordance with the terms of reference and that 
their performance is not measured appropriately.

47 
Participation in the HSC working groups is voluntary. At the end of our audit, all 
Member States had nominated their participants in the communicators’ net-
work. The Commission had also sent the request to nominate participants to the 
preparedness working group (also see paragraph 42 above), but by March 2016 
only nine EU Member States had done so. The participation of a large number 
of Member States is important to ensure that outputs of the working groups are 
later supported and taken forward by the HSC.

48 
We found that when the HSC was still informal and mandated by the terms of 
reference issued by the Council (i.e. until 2013), it had work programmes with 
annual objectives and reporting, as well as documented action plans with pro-
gress reporting. The status and mandate of the current HSC are different under 
the decision on serious cross-border threats to health. However, we did not find 
evidence in the HSC documents or at the Commission that the HSC currently 
executes its tasks on the basis of an agreed strategic planning or up-to-date 
roadmap identifying relevant longer-term strategic topics. During the course of 
the audit, Member State representatives also expressed some concern over the 
nature of the HSC audioconferences, perceived by some to be too focused on 
technical rather than strategic discussions.

27

44  Without prejudice to the audit 
findings the Court might raise 
as a result of its ongoing 
performance audit of 
Chamber III on crisis 
management structures, 
which also deals with the EU 
response to the Ebola 
outbreak.

45  Council conclusions on 

‘Lessons learned for Public 
Health from the Ebola 
outbreak in west Africa — 
Health Security in the 
European Union’, (2015/C 
421/04) of 17 December 2015.

46  See ECDC’s Rapid Risk 

Assessment ‘Outbreak of 
Ebola virus disease in west 
Africa’, fourth update, 
3 September 2014, which 
stated that the risk of Ebola 
spreading from a patient who 
arrives in the EU as a result of 
a planned medical evacuation 
was considered extremely low.

Audit observations 

49 
Overall, the work of the HSC, in particular in response to the Ebola crisis, has been 
very important and has initiated the development of collaborative mechanisms, 
such as for the use of laboratories and for medical evacuation that could be sus-
tained or reactivated for future crises44. The HSC became a main platform where 
representatives from relevant Commission services and Member States joined 
forces and started exchanging information, including with WHO. This further 
demonstrates the great relevance and importance of the HSC, which was also 
acknowledged by the Council in its conclusions on the lessons learned for public 
health from the Ebola outbreak in west Africa45.

50 
However, our evidence also shows that from the moment when Ebola was 
declared a public health emergency of international concern by WHO, for ap-
proximately 6 months, most HSC work and its audioconferences focused on the 
response to the Ebola crisis — which was a low-risk health threat for the EU 46. As 
a result, other HSC activities in relation to the strategic development and imple-
mentation of the framework of the decision on serious cross-border threats to 
health were not at the top of the agenda during this period.

51 
The high incidence of major health events in recent years, such as Middle East 
respiratory syndrome (MERS) Corona virus, Ebola and Zika and the absence of 
strategic planning for the HSC, explain to a certain extent why HSC meetings 
have often been of a technical, response-oriented nature, rather than strategic. 
In addition, we identified slow progress on the working groups which should per-
form or support the HSC’s technical work.

52 
The Commission itself can also still improve how it produces relevant mappings 
or reports on activities that take place in other Commission services, agencies 
and programmes in this context (also see paragraphs 96 to 102). These factors 
combined indicate that there is still scope for enhancing the HSC’s strategic work. 
This is important as the HSC now has a strong mandate, in particular in terms of 
coordinating, in liaison with the Commission, the preparedness and response 
planning of the Member States (see paragraph 44) and thereby ensuring the 
highest possible level of protection against health threats in the EU.

Audit observations 

28

Applying ‘coordination of response’ rules is difficult in 
practice

53 
The introduction of the decision on serious cross-border threats to health states 
that although the Member States have a responsibility to manage public health 
crises at national level, measures taken by individual Member States could 
damage the interests of other Member States if they are inconsistent with one 
another or based on diverging risk assessments. Therefore, Member States, when 
intending to adopt public health measures to combat a serious cross-border 
threat to health, should47 first inform and consult the other Member States and 
the Commission on those measures. If the need to protect public health is so ur-
gent that the immediate adoption of the measures is necessary they may inform 
the other Member States and the Commission after the adoption.

47  According to Article 11 of 

Decision No 1082/2013/EU.

48  ECDC’s Rapid Risk Assessment 
‘Outbreak of Ebola virus 
disease in west Africa’, fourth 
update, 3 September 2014, or 
ECDC’s Technical Report 
‘Infection prevention and 
control measures for Ebola 
virus disease — entry and 
Exist screening measures’, 
12 October 2014.

49  Report on the implementation 
of Decision No 1082/2013/EU, 
COM(2015) 617 final of 
7 December 2015.

54 
Experience during the Ebola crisis showed that this requirement to inform other 
Member States (i.e. through the HSC) before taking measures at national level is 
challenging. Some Member States decided to diverge from ECDC and WHO risk 
assessments and implemented entry screening of travellers at airports receiving 
flights from west Africa. In their subsequent risk assessments, ECDC and WHO 
continuously did not recommend entry screening measures, pointing at the cost 
implications, poor results and existence of effective exit screening in the affected 
countries48. The Commission invited EU health ministers to a high-level Ebola 
coordination meeting on 16 October 2014 where possible entry measures at EU 
borders were also discussed. One of the outcomes was for the Commission and 
WHO to organise an audit on exit screening for Ebola in the affected countries 
in west Africa. The audit concluded that the exit screening processes were well 
 implemented and that the procedures were very likely to catch persons with 
signs and symptoms of Ebola.

55 
In its 2015 implementation report49 the Commission therefore stated that a major 
conclusion from the Ebola outbreak was that there was scope for improving the 
implementation of the provisions which require Member States to coordinate 
national responses. If information on national public health measures which 
Member States are considering taking or have taken is not adequately shared 
with other Member States at an early stage, this could impact other Member 
States. Examples include duplications of checks and tracing of people that have 
already been checked on their first entry to the EU, requiring additional efforts 
and resources from other Member States or increased media pressure on public 
health authorities to explain why certain Member States follow WHO or ECDC 
scientific advice and others do not.

Audit observations 

29

The important role of existing systems and procedures 
for early warning and response and epidemiological 
surveillance is widely recognised but there are certain 
upgrades to be made

56 
We examined whether the existing systems for early warning and response and 
epidemiological surveillance, for which the decision on serious cross-border 
health threats provides the legal basis (also see Figure 1), are adequately man-
aged and implemented. Overall, we found that these existing systems have been 
operational for years and that their important role at EU level is widely recog-
nised by stakeholders, but that certain upgrades were needed to procedures and 
systems. In the following paragraphs we report on the need for further enhance-
ments of the EWRS and interfacing with other alert systems and the fact that the 
updated EU-level approach to early warning and response for serious chemical 
and environmental threats is not yet tested. Finally, further work is required on 
the EU system for epidemiological surveillance for optimising data comparability 
and quality.

Despite extensive use and wide appreciation of the EWRS, 
further enhancements are needed, including for the 
interfaces with other alert systems

57 
The decision on serious cross-border threats to health provides the legal basis 
for the EWRS for notifying at Union level alerts in relation to serious cross-border 
threats to health. The EWRS should enable the Commission and the competent 
authorities responsible at national level to be in permanent communication for 
the purposes of issuing alerts, assessing public health risks and determining 
the measures that may be required to protect public health. ECDC should sup-
port and assist the Commission by operating the EWRS and by ensuring with the 
Member States the capacity to respond in a coordinated manner. ECDC should 
analyse the content of messages received by it via the EWRS and should provide 
information, expertise, advice and risk assessment.

58 
The Commission and ECDC should also take action to ensure that the EWRS is 
efficiently linked with other Community alert systems (e.g. animal health, food 
and feed and civil protection). Based on these standards, we have made a general 
assessment of the EWRS’s adequate functioning and management.

Audit observations 

30

59 
Following the adoption of the decision, the EWRS has been modified to include 
changes, such as the addition of new data fields for threats other than commu-
nicable diseases and the integration of the definitions on alert notification. We 
found that the EWRS is widely used by the relevant Member State authorities and 
the Commission. Since 2004, 1 493 messages have been initiated in the EWRS by 
the Member States and the Commission (see Figure 2). However, despite updates 
and upgrades over time, we found that it has inherent system limitations due to 
the outdated system design, which does not allow for the integration of the lat-
est IT tools, social media connections or full mobile device compatibility.

2 Messages initiated in the EWRS (2004-2015)
e
r
u
g
i
F

350

300

250

200

150

100

50

0

These 1 493 messages concerned 1 482 
communicable disease events since 2004, 
and since 2014:

-  1 chemical event;
-  6 environmental events; 
-  4 potential threats of unknown origin.

In total, 725 messages were classified as 
an alert notification or early warning.

AT

BE

BG

CH

CY

CZ

DE

DK

EC1

EE

ES

FI

FR

GR

HR

HU

IE

IS

IT

LT

LU

LV

MT

NL

NO

PL

PT

RO

SE

SI

SK

UK

1  EC is European Commission

Source: ECA, based on EWRS data provided by ECDC in October 2015.

 
Messages initiated in the EWRS (2004-2015)

Audit observations 

31

60 
The latest ECDC external evaluation report50, referring to the 2008-2012 time-
frame, identified a broadly positive rating of the EWRS technical design and 
user-friendliness, but also noted that the performance of the EWRS during crises 
had been poor, stating that the system had easily overloaded in the past and that 
there appeared to be room to review the EWRS to enable it to better support 
health emergency situations.

61 
There is currently no dedicated situational awareness platform or tool at EU level 
for maintaining a real-time overview of national public health measures taken for 
dealing with a serious cross-border health threat. Either the EWRS is used for such 
purposes or emails are exchanged, for example between HSC members and the 
Commission. There is scope to develop such functionality, for example in a dedi-
cated tool or an integrated function in an enhanced version of the EWRS.

50  The second independent 
evaluation of the ECDC in 
accordance with its founding 
regulation (Regulation (EC) 
No 851/2004), Final Report of 
8 October 2014.

51  For most Member States, the 
HSC member and the EWRS 
contact point are not the same 
person. The general 
distinction is between senior 
policy staff from health 
ministries that are delegated 
to the HSC and senior 
technical staff from national 
public health agencies 
appointed as EWRS contacts, 
although other configurations 
exist.

62 
An EWRS Committee existed until 2012. This Committee dealt with technical 
aspects of health crises while the informal Health Security Committee was more 
strategically oriented at that time51. Our findings suggest that there is still a need 
to perform such technical preparatory work in the current framework (also see 
paragraph 51 on the HSC above). Options for organising a group to review public 
health risk assessments and to explore policy options had also been discussed 
between the Commission and ECDC at the time of our audit (March 2016). Setting 
up such a group was deemed necessary to avoid overwhelming the HSC, but no 
practical arrangements had been proposed or agreed.

63 
An EWRS user group or similar body to support and facilitate the work of the 
EWRS user community for functional and procedural aspects of the system’s daily 
use and potential requests for changes and upgrades, as well as training, did not 
exist at the time of the audit. However, similar activities took place in the EWRS 
Committee until 2012 and Member State representatives for the EWRS identified 
a continuing need to regularly discuss these issues.

Audit observations 

32

64 
In its 2015 implementation report52, the Commission stated that it was consider-
ing a further upgrade of the EWRS that would in the medium term allow more 
 user-friendly functions to be developed as soon as the proposal for a full reshape 
(i.e. modernisation) of the EWRS IT tool had been agreed with the stakeholders 
and ECDC. However, we could not obtain any specific Commission evidence of 
progress in this context at the time of the audit.

65 
Already in 2011, the Commission53 identified agencies and rapid alert systems at 
EU level54 that should be linked to the EWRS. The list included comments on each 
alert system justifying the need to ensure that alert notifications under the EWRS 
are linked with them. It identified objectives and gaps to be closed in relation to 
this interfacing. We examined progress made on this interfacing since 2011 and 
found that at the time of our audit (March 2016) there was still a list 55 of alert and 
information systems to be progressively linked with the EWRS.

52  COM(2015) 617 final.

53 

‘Structure for preparedness 
and response to cross-border 
health threats’ annexed to 
impact assessment 
SEC(2011) 1519 final.

54  For example alert systems for 

non-food dangerous 
products, for animal health 
and food safety.

55  Annex to the Draft 

Implementing Act under 
Article 8 of Decision 
No 1082/2013/EU, not yet 
adopted at the time of the 
audit.

56  COM(2015) 617 final.

66 
The issue of linking alert systems is important, as different EU alert systems (e.g. 
Europhyt for plant health or RAPEX for dangerous non-food products) managed 
by different Commission services may also have different contact points in Mem-
ber States, making appropriate channelling of communication at national and EU 
levels essential.

67 
According to the Commission56, full completion of the (procedural and techni-
cal) interfacing activities might not be achieved until there is more clarity on 
the scope and impact of the ‘full reshape’ of the EWRS IT tool as described in 
the previous paragraphs. In the meantime, effective procedures still need to be 
in place to avoid any overlap or duplication of activities and to ensure effective 
early response to alerts for different threats.

Audit observations 

33

57  Article 10 of Decision 

No 1082/2013/EU on public 
health risk assessments.

58  When preparing its policy and 

proposals relating to 
consumer safety, public health 
and the environment, the 
Commission relies on 
independent Scientific 
Committees to provide it with 
sound scientific advice. The 
Scientific Committees can call 
on additional expertise from 
scientific advisers and 
a database of experts. One of 
three committees launched in 
2009 was the Scientific 
Committee on Health and 
Environmental Risks (SCHER). 
It was replaced by the new 
SCHEER Committee in 2016.

68 
Overall, we found that the EWRS has been operational for many years and that its 
important role at EU level is widely recognised by stakeholders, including EWRS 
users consulted during our audit. However, the Commission and ECDC had not 
yet taken substantial action to further enhance the EWRS and develop integrated 
solutions for situational awareness and incident management for serious cross-
border threats to health. In addition, the procedural or technical interfacing with 
other rapid alert systems at Union level was not yet completed.

The updated EU level approach to early warning and 
response for serious chemical and environmental threats is 
not yet tested

69 
If a threat is raised in accordance with the alert notification rules of the decision 
on serious cross-border threats to health, the Commission should make available 
to the national competent authorities and to the Health Security Committee, 
through the EWRS, a risk assessment of the potential severity of the threat to 
public health, including possible public health measures57. ECDC should prepare 
such a risk assessment if the threat concerns a communicable disease, AMR or 
related special health issues, or is of unknown origin. The European Food Safety 
Authority and other Union agencies can also be requested by the Commission to 
provide the risk assessment if appropriate. Where the risk assessment needed is 
totally or partially outside the mandates of the Union agencies, and it is consid-
ered necessary for the coordination of the response at Union level, the Commis-
sion should provide an ad hoc risk assessment. We examined how this would 
work in practice.

70 
For chemical and environmental threats, the decision gives full discretion to the 
Commission to source a rapid risk assessment from any appropriate source. At the 
time of the audit, rapid risk assessments for chemical threats were sourced from 
an EU co-funded project. The project developed a comprehensive toolkit to deal 
with such threats, but came to an end in March 2016. In order to fulfil its legal 
obligation to provide rapid risk assessments for these threats after that date, the 
Commission developed a standard operating procedure with its Scientific Com-
mittee58, which took over some, but not all, of the project’s outputs to provide 
the required capacity.

Audit observations 

34

71 
The frequency of serious cross-border chemical incidents is generally low, but 
their nature entails that there may be a requirement to deliver rapid risk assess-
ments in timeframes as short as 12-36 hours, and out of office hours. The Scien-
tific Committee did not provide its scientific advice on such a basis before.

59  Rapid Alert System for 

chemical threats: RASCHEM.

72 
An exercise held by the same project in 2016 further illustrated the added value 
of the components of its toolkit for dealing with chemical threats. It showed 
that once all experts in the Scientific Committee’s Working Group on rapid 
risk assessment for chemical threats was recruited (the call for experts closed 
on 9 May 2016), a significant training and exercise effort would most likely be 
required until this mechanism reached optimal effectiveness to deliver rapid 
risk assessments of the required quality and within the required timeframes. In 
addition we found that the hosting of the IT tool59 developed by the project, 
for monitoring potential serious chemical incidents before alerting them to the 
EWRS, had indeed been taken over from the project by the Commission. Howev-
er, only 14 Member States had registered users at the time of our audit, meaning 
that there is no full and consistent EU coverage for this type of threat reporting. 
The Commission did not provide clear evidence of how the platform would be 
moderated and maintained, or how training and promotion of its use would be 
organised.

73 
The standard operating procedure for rapid risk assessments to be performed by 
the Scientific Committee only referred to chemical incidents and did not mention 
environmental threats. We did not identify any other standard operating proce-
dure at the level of the Commission for obtaining rapid risk assessments for seri-
ous cross-border environmental threats. Overall there was little EU-level experi-
ence in responding to serious cross-border chemical or environmental threats, 
and the relevant updated monitoring and early response arrangements for such 
threats were yet to be tested.

Audit observations 

35

60  Chapter III of Decision 
No 1082/2013/EU.

61  A case definition is a set of 

commonly agreed criteria that 
have to be fulfilled in order to 
accurately identify cases of 
a targeted serious cross-
border threat to health.

62  ECDC Chapter 9.1 Surveillance 
‘Context and future outlook’.

63  ECDC collects, analyses and 

disseminates surveillance data 
on 53 communicable diseases 
and related special health 
issues from all 28 European 
Union (EU) Member States and 
two of the three remaining 
European Economic Area 
(EEA) countries (Iceland and 
Norway) (http://ecdc.europa.
eu/en/activities/surveillance/
Pages/index.aspx).

64  Commission Implementing 
Decision 2012/506/EU of 
8 August 2012 amending 
Decision 2002/253/EC laying 
down case definitions for 
reporting communicable 
diseases to the Community 
Network under Decision 
No 2119/98/EC of the 
European Parliament and of 
the Council (OJ L 262, 
27.9.2012, p. 1).

The EU system for epidemiological surveillance generally 
works well, but some further work is required to optimise 
data comparability and quality

74 
The Commission should60 establish and update procedures for the operation of 
the epidemiological surveillance network as developed in application of spe-
cific provisions in the ECDC founding regulation. In addition, when reporting 
information on epidemiological surveillance, the national competent authori-
ties should, where available, use the case definitions61 adopted in accordance 
with the decision for each communicable disease and related special health 
issue included in an EU list of diseases. The Commission adopts case definitions 
to ensure data comparability and compatibility at Union level. ECDC hosts and 
operates the epidemiological surveillance platform TESSy to which Member 
States upload their surveillance data. Improving the quality of surveillance data 
collected at a  European level constitutes one of ECDC’s objectives in its long-term 
surveillance strategy for 2014-2020. ECDC’s strategic multiannual programme62 
also states that data quality and comparability across Member States can be 
increased.

75 
ECDC and surveillance experts in the Member States have collaborated to 
develop surveillance standards in order to streamline EU surveillance and to 
improve data quality. ECDC considers Member States’ compliance with report-
ing requirements to be overall satisfactory. However, data quality (complete-
ness and representativeness) is often problematic. ECDC has conducted specific 
data quality assessments on three63 diseases to assess quality indicators such as 
completeness, precision and validity. These assessments have identified multiple 
shortcomings for these criteria.

76 
A project run by ECDC since 2009 devoted to improving the quality of data col-
lected by the national surveillance systems was planned to finish in 2011, but 
was still ongoing at the end of 2015. Finally, according to ECDC, one of the fac-
tors contributing to the data quality issues is the fact that Member States often 
choose to use other case definitions than the EU case definitions established by 
a 2012 Commission implementing decision64.

77 
Overall, we therefore found that ECDC’s efforts to address issues in epidemiologi-
cal surveillance data reporting have not yet been fully effective to ensure optimal 
data comparability and quality. Member States could also still improve in this 
area by consistently using EU-level case definitions and optimising their data 
delivery to ECDC.

Audit observations 

36

The performance of the health programme as regards 
protecting citizens from health threats showed 
weaknesses

65  Article 2(1) of Decision 
No 1350/2007/EC.

78 
We examined whether the EU health programmes are making effective contri-
butions to protecting citizens from threats to health. This included a detailed 
examination of the management by the Consumer, Health, Agriculture and 
Food Executive Agency (Chafea) and performance of 20 actions (see Annex III 
for an overview) funded under the health threats objective of the second health 
programme (see paragraph 11), including visits to coordinating beneficiaries 
of seven projects. We also audited the progress of the health threats objective 
under the current third health programme in terms of relevant actions formu-
lated in the annual work plans and the related performance measuring by the 
Commission. Overall, we found that the performance of the health programmes, 
as regards protecting citizens from (serious cross-border) health threats, showed 
weaknesses. In the following paragraphs we report on the lack of sustainable 
results for health threat actions under the second health programme (2008-2013) 
and weaknesses in measuring the indicator for the health threat objective under 
the third health programme. For the 2014-2016 period we also found a relatively 
low level of spending on health threat actions, considering the importance and 
ambition of the relevant objective and available resources.

Lack of sustainable results for health threat actions under 
the second EU health programme

79 
The second health programme should65 complement, support and add value to 
the policies of the Member States by protecting and promoting human health 
and safety and improving public health. The programme has three objectives, 
one of which is to improve citizens’ health security. Under this objective, the ac-
tion covered in the scope of this audit is Action 1.1: Protect citizens against health 
threats.

80 
The EU financial regulation requires the budget to be implemented in compli-
ance with the principles of sound financial management (i.e. economy, efficiency 
and effectiveness). The principle of effectiveness requires attaining the specific 
objectives set and achieving the intended results. The Commission and Chafea 
need to ensure that the co-funded actions contribute to achieving the objectives 
of the health programme. We also consider that results delivered by the funded 
actions, provided that they are of sufficient quality, should be sustained and 
promoted after the actions finish, in order to ensure that there is an impact and 
added value from them.

Audit observations 

37

81 
Most of the 14 projects 66 in our sample of 20 actions performed well in terms of 
producing the agreed deliverables (except for two, which were rated by Chafea 
as ‘fair’ and failed to produce some of the required deliverables, or to the re-
quired quality). However, we found that many deliverables, even if very practical 
or ready for use (e.g. toolkits, protocols, guides) were not being used after the 
projects had finished, or no clear demonstration could be provided of how the 
deliverables influenced policymaking at national or EU levels. For nine out of the 
12 completed actions audited we identified significant issues concerning the lack 
of sustainability of results, which in many cases were also identified in Chafea’s 
own internal assessment notes prepared at the end of these projects (see Box 5 
for examples).

66  The sample included 

14 projects, one joint action 
and five procurement actions 
(see Annex III).

67  The Court has already 

recommended that the 
Commission evaluate projects 
ex post in order to improve the 
design of forthcoming 
projects by applying lessons 
learnt: see Recommendation 2 
of Special Report 2/2009 on 
the first health programme 
(2003-2007).

82 
In addition, we found that Chafea and/or the Commission give very limited tech-
nical feedback on the content of project deliverables and policy relevance when 
the projects finish. This was also confirmed by the beneficiaries that we visited 
on the spot. When they finish, Chafea assesses projects’ potential for the broader 
policy context and the relevance of the action for DG Health and Food Safety’s 
policy. However, we found that DG Health and Food Safety, despite having access 
to these Chafea files, does not systematically review the information included in 
them to assess which role it can play in taking results marked as relevant for its 
policies further at EU level or enabling a stronger or wider EU impact 67. During 
our visits to project coordinators we discussed their concerns that despite sig-
nificant dissemination activities required under the grant agreement, they find it 
challenging to reach specific target audiences, in particular EU-level and national 
level policymakers.

5
x
o
B

Examples of audited projects and issues found

Our audit work for one project in the sample showed that part of the project results could not be sustained 
because the network of specialists using the developed IT platform largely ceased to function after the pro-
ject ended. We also audited a project with extensive research components, which proved to be overly com-
plex and costly. The main objective of this project was not achieved. This was in part due to the fact that 
lessons from the project’s predecessor were not duly taken into account and ambitions were therefore set too 
high. In a third project for screening of a specific disease in certain populations we found that the project was 
very successful at delivering the required high-quality outputs, but its outputs were not updated further 
after the project finished, nor widely used. The contributions of these projects to the health programme’s 
health threats objective would therefore rapidly decrease with time.

 
Audit observations 

38

83 
The ex post evaluation of the health programme68 listed similar issues saying 
that even though a considerable effort was made during the second half of the 
programme to enhance dissemination, there remained room for improvement 
in terms of raising awareness among relevant stakeholders of the results69 of 
co-funded actions, in order to maximise their uptake and impact70. In addition, 
the evaluation report identified that if policy links are absent, it is difficult to 
overcome barriers for EU-wide implementation of results. According to the same 
report, not all co-funded actions were particularly effective when it came to 
achieving tangible and useful results and impacts. While joint actions (see Box 6) 
typically achieve a tangible impact, the report said, projects relatively often fail 
to see their results taken forward and put into practice. Among other reasons this 
was due to insufficient attention being paid to key barriers to implementation 
and engagement of relevant enablers71.

84 
As regards the five procurement items (see Annex III) that we audited at 
DG Health and Food Safety and Chafea, we also identified a limited uptake of 
outputs and evaluation of results. Recommendations from final activity and eval-
uation reports for exercises and workshops/trainings were generally not integrat-
ed in action plans whose implementation could be monitored72. Two  exercises 
(held in 2011 and 2014) included in our sample of five procurement items covered 
chemical threats and identified many similar and also some identical issues and 
recommendations.

68  Ex post evaluation of the 

health programme (2008-
2013), 2016.

69  The text in this paragraph is 

paraphrased from the ex post 
evaluation report. The use of 
the terms ‘results’ and 
‘impacts’ here is therefore not 
necessarily aligned with the 
Court’s methodology.

70  Executive summary of the ex 
post evaluation of the health 
programme (2008-2013), 2016.

71  Conclusions of the ex post 

evaluation of the health 
programme (2008-2013), 2016.

72  This also concerned four 

studies procured under a 2012 
framework contract for which 
we found that DG Health and 
Food Safety had no structured 
approach for collecting and 
documenting the 
recommendations, identifying 
relevant actions and 
monitoring implementation 
progress. These studies had 
also not been disseminated to 
the HSC at the time of the 
audit (October 2015).

6
x
o
B

Joint actions under the health programme

The EU health programme includes an innovative, promising funding instrument called ‘Joint Actions’. These 
are generally co-financed by competent authorities responsible for health in the Member States. Joint actions’ 
proposals should provide a genuine European dimension. On average, joint actions have included 25 part-
ners73. The fact that joint actions involve or get support from national competent authorities for public health 
should allow for a better uptake of results and policy impact. However, given their significant size, they take 
more time to prepare and also require political backing and national co-funding. This means that, despite 
their potential for increasing the EU-wide take up of outputs produced with health programme funding, there 
cannot be too many subsequent joint actions in one policy area.

73  Chafea publication on joint actions under the third health programme (2014-2020).

 
Audit observations 

39

85 
Two actions implemented under administrative arrangements with the Joint 
 Research Centre were discontinued after 1 year and 6 years respectively. When 
the first action for an epidemiological modelling network was discontinued, 
the Commission did not make an assessment of the action results and did not 
document its considerations to close the action. The second action continued for 
6 years, from 2005 until 2011. It concerned an information exchange platform for 
public health situations. It was developed at the request of Member States based 
on discussions within the HSC, but was discontinued in 2012, when the Commis-
sion decided to close all existing IT systems that were not integrated in any legal 
base.

74  As already recognised by the 

Court in paragraph 88 of its 
Special Report 2/2009 on the 
first health programme 
(2003-2007).

75  There have been no calls for 

projects in 2014, 2015 and 2016 
for the health threats 
objective.

86 
Notwithstanding the issues presented above, there is evidently high added value 
in the audited projects in terms of EU-wide networking and capacity building74. 
All project grants are implemented by consortia of partners, and although the 
geographical spread in this part of the health programme is not yet optimal and 
there is a certain concentration of activities with a limited number of national 
agencies, much experience has been gained. However, the Commission does not 
take sufficient structured action, in collaboration with its partners, agencies and 
committees, to optimise the policy feedback loop. This is an issue, in particular 
because the health programme is a policy driven programme.

87 
We found that in the third health programme (2014-2020) (also see para-
graphs 89 to 94 below), there was a shift from projects to procurement 75. This is 
a different funding mechanism putting the ownership of the outputs with the 
Commission. However, as already mentioned in the Ex-post evaluation of the sec-
ond health programme, there is a risk that excessive reliance on service contracts 
would be detrimental to health programme inclusiveness (in terms of types and 
geographic spread of beneficiaries). Our audit work for the second health pro-
gramme showed (see paragraph 84) that also in the area of procurement, Chafea 
and the Commission could have performed better in ensuring sustainable results.

88 
Overall, the sustainability of results is not ensured for most of the audited actions 
under the health threats action of the second health programme, limiting their 
contribution towards achieving the objective of protecting citizens from threats 
to health. The Commission could take more effective action to help bene ficiaries 
in overcoming barriers for targeted dissemination and assessing and promoting 
the policy relevance of completed actions.

Audit observations 

40

76  Regulation (EU) No 282/2014.

77  Annex II to Regulation (EU) 

No 282/2014.

78  The full 2016 update was still 

ongoing at the time.

79 

In an updated version of this 
mapping the figures had been 
increased to a total forecast 
amount of 14 685 000 euro for 
Objective 2 representing 
3.63 % of the total health 
programme for 2014-2020.

80  No calls for projects were 

launched under this objective 
in 2014, 2015 or 2016.

81  According to the forecasts, 

Objective 3 would take 52.5 %, 
and Objectives 1 and 4 
approximately 20 % of the 
budgetary resources for the 
programme.

Weaknesses in measuring the indicator for the health threats 
objective under the third EU health programme (2014-2020) 
and a relatively low level of spending in 2014-2016

89 
The third health programme for Union action in the field of health (2014-2020)76 
covers four specific objectives and indicators, one of which (i.e. Objective 2) 
addresses serious cross-border threats to health: ‘In order to protect Union 
citizens from serious cross-border health threats: identify and develop coher-
ent approaches and promote their implementation for better preparedness and 
coordination in health emergencies’. The objective should be measured through 
the increase in the number of Member States integrating coherent approaches 
in the design of their preparedness plans (also see paragraphs 30 to 34). Thus 
the funded actions should contribute to achieving this specific objective, and 
methodologies should be in place to effectively measure the progress through 
the specific indicator.

90 
The financial envelope for the implementation of the 2014-2020 programme is 
449 million euro. The criteria for establishing annual work programmes 77 say that 
there should be a balanced distribution of budgetary resources between the dif-
ferent objectives of the programme.

91 
We analysed the Commission’s internal multiannual planning established in 2013, 
and a draft 2016 update78 which we received during the audit. For Objective 2 
activities were initially planned for three out of the four underlying thematic 
priorities. The budget overview showed that the expected overall amount for 
the period 2014-2020 for Objective 2, covering all different funding mechanisms, 
would be 12 069 000 euro, or 3 % 79 of the total programme amount across all four 
objectives.

92 
Even if the details and potential adjustments of the 2016 review of the indica-
tive multiannual planning and the potential changes for Objective 2 were not 
yet available at the time of our audit, the evidence showed that fewer actions 
had been included in the annual work programmes for 2014 and 2015 than were 
initially planned80. Consequently, the programme was not on track to spend the 
forecast 3 % of the total available resources on Objective 2 by 2020. This casts 
doubt over whether the relatively low level of spending for this objective is suf-
ficient to achieve this important and ambitious objective, and does not achieve 
a balanced distribution of budgetary resources between the objectives81.

Audit observations 

41

93 
We also examined whether there was a clear methodology for measuring the 
specific indicator associated with Objective 2 (see paragraph 89). Similar to our 
observation in paragraphs 30 to 34, we could not identify such a methodology. 
Chafea collects certain information on the implementation of the health pro-
gramme, in collaboration with the national focal points of the health programme 
in the Member States, but not with the specific aim of quantifying the progress 
under this indicator on the basis of projects’ results and outcomes. Although the 
results of the few actions funded until now under Objective 2 of the third health 
programme were not assessed in this audit, we find that there is no clear 
method ology to measure the progress under the relevant specific indicator from 
the funded actions.

94 
Overall, the measuring of the indicator for the third health programme’s ob-
jective to protect citizens from serious cross-border threats to health showed 
weaknesses and there was a relatively low level of spending for this objective in 
2014-2016, in any case much lower than for the other main objectives of the pro-
gramme. This raises concerns over whether a sufficient number of policy-relevant 
actions to achieve some balance between the objectives, and make a real impact 
for serious cross-border threats to health, can be funded by 2020.

There are gaps in the Commission’s internal 
coordination in terms of health security activities and 
public health crisis management

95 
We examined whether the Commission’s internal coordination in terms of health 
security funding and public health crisis management is adequate. Overall the 
audit revealed that a number of gaps exist in this internal coordination. The 
co ordination between Commission services for health security funding from 
different EU programmes does not fully ensure the achievement of synergies. 
More progress is needed in operationalising the cooperation between Commis-
sion crisis management structures and we found weaknesses in the Commission’s 
management of its Health Emergencies Operations Facility.

Audit observations 

42

Coordination between Commission services for health 
security funding from different EU programmes does not 
fully ensure synergies

96 
In order to ensure that health security objectives of the health programmes are 
achieved in the most efficient way, the work of relevant services at the Commis-
sion and its agencies should be effectively coordinated. In implementing the 
EU budget, the European Commission needs to ensure sound financial manage-
ment and that the use of EU resources achieves EU added value. The Commission 
should also, in cooperation with the Member States, ensure overall consistency 
and complementarity between the programme and other policies, instruments 
and actions of the Union, including those of the agencies82.

82  See Article 12 of Regulation 

(EU) No 282/2014 establishing 
the third health programme.

83  We tested to what extent the 

relevant policy unit in 
DG Health and Food Safety 
coordinated its involvement in 
or informed itself on relevant 
research-funded actions. 
During visits to DG Migration 
and Home Affairs, DG 
Research and Innovation, the 
Research Executive Agency 
and the European Research 
Council, we discussed 
coordination structures in 
place and tested the relevance 
of these projects for DG Health 
and Food Safety.

97 
We analysed a sample of 10 projects funded under the seventh research frame-
work programme (FP7), representing a total level of EU co-funding of approxi-
mately 50.8 million euro. We selected projects with a potential relevance to 
DG Health and Food Safety’s policy area of health security based on an analysis 
of their objectives, originating from different strands of the FP7 programme (see 
paragraph 12) and managed by different Commission services or agencies. We 
reviewed the objectives and scope of the projects, and their complementarity to 
the relevant health threats objectives of the health programme83.

98 
DG Health and Food Safety is generally involved in all formal coordination struc-
tures and procedures for FP7 and for Horizon 2020, including inter-service consul-
tations for the work plans of Horizon 2020 and for relevant grant award decisions. 
DG Research and Innovation participates in DG Health and Food Safety consul -
tation procedures for the health programme and the wider policy area and is 
involved in the evaluation of proposals submitted under the health programme. 
DG Research and Innovation is also on the ECDC management board.

43

84 

Interim Evaluation of FP7 
Security Research, Executive 
Summary, January 2011.

Audit observations 

99 
We found that despite the scientific character of FP7 health and security projects, 
six projects we reviewed showed clear links with certain projects that we ex-
amined under the EU health programme. These often focused on preparedness 
and aimed to produce tangible, policy-relevant outputs. One potential reason is 
that two of the reviewed projects are so-called coordination and support actions 
(CSAs). These are actions that do not cover the research itself, but rather coordi-
nation and networking, dissemination and use of knowledge, or studies or expert 
groups assisting the implementation of the programme.

100 
The other Commission services interviewed indicated that upon request from 
policy DGs they can perform analyses of their project portfolios, but DG Health 
and Food Safety had not requested this for the health threats area.

101 
The Commission experience of these research programmes, in particular the 
security strand of FP784, shows that there is a need to better involve end-users to 
ensure a better take-up of results, similar to the issues we found in relation to the 
health programme (paragraphs 79 to 88 above). DG Migration and Home Affairs 
took the initiative to develop a ‘Community of Users for Disaster Risk and Crisis 
Management’, which provides a forum for information exchanges between users 
and other stakeholders. The forum should also facilitate synergies by performing 
regular surveys of projects from different calls, and by organising ad hoc meet-
ings for exchanging views between policymakers and stakeholders to discuss 
synergies. A comprehensive mapping of EU-supported actions as part of the 
community of users is a promising initiative that could potentially be developed 
for other policy or thematic areas.

102 
Projects operating in the same thematic area might be funded from different EU 
programmes. High volumes of EU funding from different thematic programmes 
and the involvement of a range of Commission services in their management, 
requires complex networking between Commission services, national policy 
makers, end-users and other stakeholders. The risk of overlaps, though minor, 
persists, and opportunities for achieving more synergies remain. In this context, 
there is scope for better policy-oriented and structured coordination, in particu-
lar for health security policy and related actions. We found that DG Health and 
Food Safety could do more structured work to facilitate this type of coordina-
tion and to allow it to better steer policy feedback and dissemination of relevant 
results to its own stakeholder group and the HSC.

44

85 

I.e. HEOF (Health Emergency 
Operations Facility ) 
—  DG Health and Food 
Safety, STAR  (Strategic 
Assessment and Response) 
— DG Migration and Home 
Affairs and ERCC (Emergency 
and Response Coordination 
Centre) —  DG European Civil 
Protection and Humanitarian 
Aid Operations.

86  Summary report on the 

conference ‘Lessons learned 
for public health from Ebola 
outbreak in west Africa —  
how to improve preparedness 
and response in the EU for 
future outbreaks,’ Mondorf les 
Bains (Luxembourg), 
12-14 October 2015, p. 23.

Audit observations 

More progress needed in operationalising cooperation 
between Commission crisis management structures

103 
A memorandum of understanding signed in May 2013 by DG Health and Food 
Safety, DG Migration and Home Affairs and DG European Civil Protection and 
Humanitarian Aid Operations covers the coordination of their respective crisis 
management structures85. This coordination should encompass cross cutting 
activities on serious cross-border threats to health in all areas where joint efforts 
would be of mutual advantage. This includes training and exercises on prepared-
ness, risk assessment and the provision of mutual support during the response 
phase and when drawing lessons learned after crises. Secured communication 
channels between the respective crisis centres are also foreseen.

104 
The memorandum of understanding was put in place to increase the EU’s capac-
ity to respond to major multi-sector emergencies. However, we found that at 
the time of the audit, standard operating procedures to implement the agree-
ment were still being developed. Although DG Migration and Home Affairs, 
DG European Civil Protection and Humanitarian Aid Operations and DG Health 
and Food Safety have been active in preparing, planning, conducting and utilis-
ing the outcomes of a series of joint exercises, we could not obtain evidence at 
DG Health and Food Safety that there had been systematic joint training sessions, 
workshops or regular meetings involving key crisis management staff operating 
the crisis management facilities of DG Health and Food Safety, DG Migration and 
Home Affairs and DG European Civil Protection and Humanitarian Aid Operations 
as planned in the agreement. The lack of progress on these issues was to a large 
extent due to the evolving Ebola crisis, when it was difficult to organise develop-
ment work.

105 
The report on the 2015 Ebola lessons learned conference86 includes recommenda-
tions for actions regarding crisis management at EU level. It stated that coopera-
tion between public health and development aid partners and other key actors 
at various levels should be enhanced to better coordinate and integrate public 
health considerations in resilience building and response to emergencies. To this 
end, common response plans and further joint training, exercises, exchange of 
best practices and cross-sectoral guidelines should be pursued. According to the 
report, the Commission’s Emergency Response Coordination Centre should be 
further developed as an information exchange and coordination platform at EU 
level for public health crises originating from outside the EU, in close coopera-
tion with the Health Security Committee. Although it was mostly addressed to 
DG European Civil Protection and Humanitarian Aid Operations which operates 
the Emergency Response Coordination Centre (ERCC), we did not find, at the time 
of the audit, a specific action plan for DG Health and Food Safety’s involvement 
in the follow-up of these recommendations.

45

87 

I.e. green (normal duty), 
orange (medium or major 
events) and red (acute crisis).

88  ECDC PHE Evaluation SOP: 
Processes of activation of 
a level 1 or 2 due to a threat or 
a simulation exercise should 
be evaluated and lessons 
learned incorporated into the 
management of the updated 
PHE plan.

89  Health Emergency Operations 
Facility for a coordinated 
management of public health 
emergency at EU level — 
Revised practical guidance for 
HEOF members (April 2015).

90  Quicksilver Exercise: 

‘Command Post Exercise on 
serious cross-border threats to 
health falling under the 
chemical and environmental 
categories’, Final Report.

Audit observations 

106 
The memorandum of understanding between the three DGs referred to above is 
an important step in increasing preparedness at EU level for serious cross-border 
threats to health and other major multi-sector emergencies. However, our audit 
work at DG Health and Food Safety showed that more progress is needed to im-
plement this memorandum, notwithstanding the extensive cooperation between 
DG Health and Food Safety and DG European Civil Protection and Humanitarian 
Aid Operations during the Ebola outbreak.

Weaknesses found in the Commission’s management of its 
Health Emergencies Operations Facility

107 
DG Health and Food Safety operates a Health Emergencies Operations Facil -
ity which can be activated at different alert levels87 in times of a health crisis. 
We considered that such a facility requires a structured approach to post-event 
evaluation. Emergency management plans need to be updated in accordance 
with the recommendations made in a post-event evaluation. Examples of such 
arrangements can also be found in ECDC’s public health emergency plan and its 
standard operating procedures88.

108 
In order to effectively fulfil their role in crisis management and coordination 
structures, relevant staff members should keep their knowledge of their potential 
role and systems up to date by participating in training programmes. The rel-
evant organisation needs to monitor its staff’s knowledge and awareness of their 
potential role, for example by monitoring their effective training participation. 
Clear and adequate arrangements need to be in place to ensure that an organisa-
tion with crisis coordination or management responsibilities can sustain its activi-
ties at a heightened state of alert for a prolonged period of time, and staff needs 
in this respect should be duly taken into account.

109 
The Health Emergencies Operations Facility is based on a DG Health and Food 
Safety manual89. This manual had been updated and simplified following the 
lessons learned from the 2009 H1N1 crisis. Nonetheless, we found a number of 
significant weaknesses in the Commission’s management of the Health Emer-
gencies Operations Facility. The content of the manual was not up to date at the 
time of the audit. It was insufficiently clear which parts of the specific recommen-
dations from the major 2014 Quicksilver Exercise90 had been taken up to improve 
its design. In addition, the Commission had not performed an internal evaluation 
of the functioning of the Health Emergencies Operations Facility during the Ebola 
crisis and the guide was therefore not updated accordingly.

Audit observations 

46

110 
We further found that there had not been any continuous training of relevant 
staff to ensure that they can take up their roles in the Health Emergencies Opera-
tions Facility at any given time, in particular when staff members are not part of 
the Crisis Management and Preparedness Unit but could be called for duty if the 
highest alert level is raised. Concerning staffing during periods of increased alert, 
we found that only regular compensation arrangements within the flexitime 
regime were in place, which are not adequate to address the challenges faced 
by DG Health and Food Safety in coordinating the management of public health 
emergencies at EU level, in particular when the emergency lasts for a long period 
of time and staff work in shifts without opportunities for taking compensatory 
leave.

111 
We also found that the Health Emergencies Operations Facility had not been 
‘peer reviewed’ by any other institution or agency, and that no specific ex-
changes of experiences or best practices in relation to the design and operation 
of their respective emergency management plans had been carried out between 
ECDC and DG Health and Food Safety.

Conclusions and 
recommendations

47

112 
The entry into force of Decision No 1082/2013/EU on serious cross-border threats 
to health contributes to building and strengthening a comprehensive EU frame-
work for health security, and for enabling the Union to protect its citizens from 
such threats. Developing and implementing this decision and related EU-level 
health security actions, including funding programmes, is a complex matter 
due to the multitude of actors and complex structures in place within countries 
and in the international context (see Annexes I and II ), as well as from a legal 
perspective. The Member States have the main responsibility for health policy 
(see paragraph 3), and EU action in this area is only designed to complement 
and support Member States’ activities. The Commission’s role and responsibility 
therefore consist mostly of providing support and taking complementary action 
where needed.

113 
To add to the complexity, a relatively high frequency of serious emergencies 
requires almost constant attention. There have been several such emergencies 
since the adoption of the decision and new threats could materialise quickly, 
including a major pandemic influenza hitting the EU. This means that there is 
an almost continuous need for Member States, the various relevant Commission 
services and international organisations to be engaged in response actions while 
still continuing substantial remaining work on preparedness.

114 
Against this challenging background, the existence of the decision in itself, and 
measures and programmes to support its implementation, is not enough to 
ensure optimal protection of citizens from serious cross-border threats to health 
in the EU. Moreover, the decision is an EU law whose rules need to be applied ef-
fectively and consistently by all involved to ensure that its objectives can be met. 
We therefore assessed whether the EU framework for protecting citizens from 
serious-cross-border threats to health was adequately implemented. In doing 
so, we focused on the effective implementation of the innovative and previously 
existing areas of the decision (paragraphs 7 to 9). We also addressed the ques -
tions whether the EU health programmes were making effective contributions to 
protecting citizens from threats to health and whether the Commission’s internal 
coordination in terms of health security funding and public health crisis manage-
ment was adequate (paragraphs 15 and 17).

Conclusions and recommendations 

48

115 
Our overall conclusion is that Decision No 1082/2013/EU on serious cross-border 
threats to health represents an important step for dealing better with such 
threats in the EU. However, significant weaknesses at the level of the Member 
States and the Commission affect the implementation of the decision and the 
related EU framework. While the nature and scale of future threats is unknown 
and may evolve, more needs to be done to address these weaknesses and allow 
the Union to take full benefit from its established mechanisms.

116 
We found that the implementation and development of the innovations intro-
duced by the decision on serious cross-border threats to health (paragraph 21) 
since its entry into force in December 2013 were hampered by delays, potentially 
reducing their effective functioning. The consultation between Member States 
and the Commission on preparedness and response planning for serious cross-
border threats to health has been initiated as required. However, the procedures 
for obtaining and exchanging relevant information with a view to better coordin-
ating efforts in relation to preparedness are not yet sufficiently robust and have 
not yet delivered clear-cut results (paragraphs 22 to 29). As regards the Commis -
sion’s measurement of performance for the implementation of the cross-border 
health threats policy area, we found that key elements of the Commission’s 
specific objective and indicator are not clearly defined and agreed with the 
Member States, to ensure that all stakeholders work towards the same objectives 
(paragraphs 30 to 34).

117 
We further found that: ECDC’s role in relation to generic preparedness is insuf-
ficiently formalised, which may limit its capacity to properly plan its related 
tasks in the long term or respond effectively to assistance requests (para-
graphs 35 to 39); Member States have shown insufficient responsiveness to speed 
up the joint procurement of pandemic influenza vaccine (paragraphs 40 to 43); 
and the EU does not have a mechanism to address urgent needs for medical 
countermeasures within the framework of the decision on serious cross-border 
threats to health (paragraph 42). Finally, the work and role of the HSC have 
proven to be very important, but it is facing some strategic and operational 
chal lenges which need to be tackled to enable it to make full use of its strong 
mandate (paragraphs 44 to 52) and thereby ensure the highest possible level 
of protection against health threats in the EU; this also relates to ensuring 
that the decision’s coordination of response rules can be applied effectively 
(paragraphs 53 to 55).

Conclusions and recommendations 

49

118 
It is necessary to speed up the development and implementation of the inno-
vations introduced by the decision, and tackle the remaining operational and 
strategic challenges for the HSC. This requires a better common understanding 
between Member States and the Commission of the objectives and joint priori-
ties for the enhanced coordination and information exchange efforts under the 
decision, in particular in the areas of preparedness planning, joint procurement 
and organising the work of the HSC in the long term. For preparedness and 
response planning, an additional challenge is to consider the developments oc-
curring in the wider international context as outlined in Box 3 and Annex I.

Recommendation 1

In order to speed up the development and implementation of the innovations 
introduced by the decision on serious cross-border threats to health, and tackle 
the remaining operational and strategic challenges for the HSC:

(a)  The Commission should propose to the HSC that it develop a strategic 
HSC roadmap for the implementation and development of the decision. 
While the decision does not require the setting of targets and indicators, 
this roadmap should reflect joint priorities, in particular on the coordination 
of preparedness planning, to facilitate a common understanding of how to 
achieve more clear-cut results towards 2020. Work in this area should take 
account of the international initiatives in this domain which in particular call 
for peer review or external assessment mechanisms to be applied. If possible, 
this work should also take account of preparedness guidance already devel-
oped at EU level.

(b)  The Commission should ensure that lessons learned from the first reporting 
cycle on preparedness planning are applied for the next round of reporting 
in 2017 and improve its performance reporting for the implementation of the 
decision towards 2020. It should ensure that reported progress is accurate 
and based on methodologies agreed with the Member States where relevant.

(c)  The Commission, in cooperation with the Member States, should identify 
how to best make use of the HSC working groups and ensure that their work 
is well structured around technical issues and serves as an input to the HSC. 
Working groups already established need to apply their terms of reference 
from 2017 and deliver results, based on annual work plans and clearly identi-
fied objectives. This also applies to the HSC preparedness working group and 
its work to develop an EU mechanism to address urgent needs for medical 
countermeasures.

(d)  The Commission and the Member States need to ensure that the work on 

the joint procurement of pandemic influenza vaccine accelerates and delivers 
results as soon as possible.

Conclusions and recommendations 

50

119 
As regards the effective implementation of the existing systems for early warn-
ing and response and epidemiological surveillance (paragraph 56), for which the 
decision on serious cross-border threats to health provides the legal basis, we 
found overall that these systems have been operational for years and that their 
important role at EU level is widely recognised by stakeholders. However, for 
early warning and response we found that there is scope for making upgrades to 
the EWRS, including to related procedures and processes for situational aware-
ness and incident management and the organisation of the EWRS user com-
munity (paragraphs 57 to 68). In addition, the updated EU-level approach to 
early warning and response for serious chemical and environmental threats was 
not yet tested (paragraphs 69 to 73). Finally, the epidemiological surveillance 
system generally works well, but further work by ECDC and the Member States 
is required to ensure maximum comparability and quality of surveillance data 
(paragraphs 74 to 77).

Recommendation 2

In order to further upgrade the EWRS and develop more integrated solutions for 
related risk management procedures, the Commission, in cooperation with the 
Member States and ECDC, should:

(a)  examine and propose in 2017 options for modernising and enhancing the 

EWRS. This should include integrated or complementary options for EU-level 
situational awareness and incident management for serious cross-border 
threats to health;

(b)  obtain regular feedback from users on integrated solutions for risk manage-

ment and the operation and development of the EWRS.

120 
As regards the health programme objectives to protect citizens from (seri-
ous cross-border) threats to health (paragraph 78), we found that its perfor-
mance showed weaknesses. Most of the audited health threat actions from the 
second health programme (2008-2013), despite performing well in terms of 
producing the agreed deliverables, showed a lack of sustainable results (para-
graphs 79 to 88), limiting their contribution towards achieving the objective of 
protecting citizens from threats to health. Although this is not a new observa-
tion, it underlines that the Commission needs to do more, in consultation with 
its stakeholders, to improve performance on this issue. In addition, we found 
weaknesses in measuring the indicator for the health threats objective under 
the third health programme as well as a relatively low level of spending for this 
particular objective in 2014-2016, suggesting that it is difficult to fund a sufficient 
number of policy relevant actions under this objective to ensure that a real im-
pact is made towards 2020 in achieving the objective (paragraphs 89 to 94).

Conclusions and recommendations 

51

Recommendation 3

In order to address the main weaknesses identified in the performance of the 
health programme for actions addressing health threats, the Commission 
should:

(a)  examine and propose options in 2017 for ensuring a greater sustainability 
of results for health threat-related actions funded under the health pro-
gramme towards 2020. These should include stronger needs and policy 
relevance identifications when programming actions, but also a more col-
laborative analysis between DG Health and Food Safety and Chafea of the 
policy relevance of ongoing and recently completed actions with a view to 
identifying options to promote the uptake of good-quality results (also see 
Recommendation 4);

(b)  define and agree, in consultation with the Member States, a clear methodol-
ogy for collecting performance information needed to report progress to-
wards 2020 under the specific indicator for health threats in the third health 
programme (also see Recommendation 1).

(c)  clearly identify in 2017, for the remaining years of the health programme until 
2020, which priorities under the objective to protect citizens from serious 
cross-border threats to health provide opportunities for funding policy-rele-
vant actions towards 2020 (see Recommendation 3(a).

121 
Finally, the audit revealed that, despite a wide array of coordination mechanisms, 
a number of gaps exist in relation to the Commission’s internal coordination of 
health security activities across different services and programmes to ensure that 
full use is made of potential synergies. In a context of high volumes of EU fund-
ing from different thematic programmes and a range of Commission services 
being involved in their implementation, requiring complex networking between 
Commission services, national policymakers, end-users and other stakeholders, 
there is scope for better policy-oriented and structured coordination (para-
graphs 96 to 102). We also found that more work needs to be done to make 
existing agreements for cooperation between Commission crisis management 
structures fully operational (paragraphs 103 to 106), and that DG Health and 
Food Safety’s management of its Health Emergencies Operations Facility showed 
weaknesses that might hamper its performance when dealing with future health 
crises in the EU (paragraphs 107 to 111).

Conclusions and recommendations 

52

Recommendation 4

In order to bridge the gaps in the Commission’s internal coordination in terms of 
activities relevant to health security and public health crisis management, and to 
improve the design of its Health Emergencies Operations Facility:

(a)  the Commission should define from 2017 a more structured, detailed ap-

proach for coordination between DG Health and Food Safety and other Com-
mission services which perform activities relevant to health security, includ-
ing a mapping of past, ongoing and planned activities. This should allow for 
the identification of potential synergies and enhance cooperation on com-
mon issues such as the limited uptake of outputs for EU co-funded actions 
and enabling stakeholders to better target policymakers;

(b)  the Commission should take immediate action to operationalise the 

memorandum of understanding for crisis management structures between 
DG Health and Food Safety, DG Migration and Home Affairs and DG European 
Civil Protection and Humanitarian Aid Operations; this includes organising 
joint lessons learned activities and mutual training on policy areas and sys-
tems, as well as putting in place standard operating procedures;

(c)  the Commission should without delay review its Health Emergencies Opera-
tional Facility and ensure that: it is updated in line with lessons learned from 
the Ebola crisis and major EU-level exercises; a continuous monitored training 
plan is in place for all relevant staff potentially involved in its operations; and, 
if possible, exchange views with ECDC and DG European Civil Protection and 
Humanitarian Aid Operations, in particular on the design of their respective 
crisis management manuals or structures.

This Report was adopted by Chamber I, headed by Mr Phil WYNN OWEN, Member 
of the Court of Auditors, in Luxembourg at its meeting of 5 October 2016.

For the Court of Auditors

Klaus-Heiner LEHNE
President

 
 
 
Annexes

53

I
x
e
n
n
A

Preparedness and response planning in the international context

International Health Regulations 2005 (IHR 2005)

1.  The 1969 WHO International Health Regulations were fully revised and replaced by the IHR (2005), which 
entered into force in 2007. The IHR objective is ‘to prevent, protect against, control and provide a public 
health response to the international spread of disease in ways that are commensurate with and restricted to 
public health risks, and which avoid unnecessary interference with international traffic and trade’1 . The IHR 
2005 requires State Parties to report to WHO any event that may constitute a public health emergency of in-
ternational concern, independently of its origin, and to develop, strengthen and maintain core public health 
capacities for surveillance and response by using existing national resources, such as the national plans for 
influenza pandemic preparedness. The IHR are also designed to reduce the risk of disease spread at inter-
national airports, ports and ground crossings and require the establishment of national and WHO IHR focal 
points for urgent communication.

2.  The IHR (2005) do not include any enforcement mechanism for States which fail to comply with its provi-

sions. WHO monitors the implementation of the IHR, and issues and updates relevant guidelines. Its expert 
panels and review committees also review IHR effectiveness in emergency situations, as was done, for 
example, after the Ebola outbreak (see Box 3 in the report for more information on this).

Public Health Emergencies of International Concern (PHEIC)

3.  Under the IHR, a public health emergency of international concern refers to an extraordinary public health 
event which constitutes a public health risk to other States through the international spread of disease and 
potentially requires a coordinated international response. The PHEIC is declared by the director-general of 
WHO based on a recommendation from the Emergency Committee. If a PHEIC is declared, WHO is required 
to deliver a ‘real time’ response to the emergency. The Director-General of WHO, assisted by the Emergency 
Committee, will develop and recommend the critical health measures for implementation by State Parties.

The IHR and the EU

4.  All EU Member States are State Parties to WHO and report to WHO,  for example through questionnaires 
and self-assessments, on their IHR implementation. The EU itself is not a WHO member, and therefore is 
not a party to the IHR. However, the IHR recognises the potential role of the EU as a ‘regional economic 
integration organization’ and states that, ‘without prejudice to their obligations under these Regulations, 
States Parties that are members of a regional economic integration organization shall apply in their mutual 
relations the common rules in force in that regional economic integration organization’. The Commission 
and ECDC coordinate their activities with WHO at policy2 and technical level, including information sharing 
for risk communication and read access to certain alert systems (such as the WHO Event Information System 
and the EU’s EWRS). Decision No 1082/2013/EU also introduced the innovation of a public health emergency 
declaration by the Commission, but it is significantly different from a PHEIC declaration by the Director-
General of WHO (see Box A).

1 
2 

International Health Regulations (2005), Second Edition, World Health Organisation 2008.
See for example the 2010 Joint Declaration (‘Moscow Declaration’) outlining cooperation between WHO and the Commission, as well as relevant 
updates on DG Health and Food Safety’s public website. An administrative agreements is also in place between ECDC and WHO.2ww

 
Annexes 

54

I Box A — Public health emergency declaration in the EU
x
e
n
n
A

As explained above, the term Public Health Emergency of International Concern is defined in the Interna-
tional Health Regulations as ‘an extraordinary event which is determined, as provided in these Regulations: 
to constitute a public health risk to other States through the international spread of disease; and to poten-
tially require a coordinated international response’. The responsibility of determining whether an event 
is within this category lies with the WHO Director-General and requires the convening of a committee of 
experts — the IHR Emergency Committee.

One of the innovations of Decision No 1082/2013/EU is that the Commission can now also declare a situa -
tion of public health emergency for the EU. In accordance with Article 12, the Commission may recognise 
a situation of public health emergency in relation to: (a) epidemics of human influenza considered to have 
pandemic potential, where the Director-General of WHO has been informed and has not yet adopted a deci-
sion declaring a situation of pandemic influenza in accordance with the applicable rules of WHO; or (b) cases 
other than that referred to in point (a) where the Director-General of WHO has been informed and has not 
yet adopted a decision declaring a public health emergency of international concern in accordance with the 
IHR, and where:

(i) 

the serious cross-border threat to health in question endangers public health at the Union level;

(ii)  medical needs are unmet in relation to that threat, which means that no satisfactory method of diagno-

sis, prevention or treatment is authorised in the Union or, despite the existence of such a method, the 
authorisation of a medicinal product would nonetheless be of major therapeutic advantage to those 
affected’.

Article 13 then adds that this recognition of an emergency situation pursuant to Article 12 shall have the 
sole legal effect of enabling point 2 of Article 2 of Regulation (EC) No 507/2006 3 to apply or, where the 
recognition specifically concerns epidemics of human influenza considered as having a pandemic potential, 
of enabling Article 21 of Regulation (EC) No 1234/2008 4 to apply. This means that the purpose of emergency 
declaration under Article 12 of Decision No 1082/2013/EU is restricted only to a fast track authorisation for 
pandemic medical countermeasures and operationalising pharmaceutical legislation. Its application is much 
more limited compared to a declaration of a Public Health Emergency of International Concern by WHO, 
even though situations could occur where a serious cross-border threat to health, from any potential origin, 
specifically affects the EU and not necessarily the wider global community for which WHO is responsible. It 
also means that there is no EU scale of alert levels (e.g. linked to the rules of procedure of the Health Secu-
rity Committee) triggering response activities and capacities within the remit of the decision or to ensure 
the triggering of a mechanism for surge capacity or funding.

3  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 (OJ L 92, 30.3.2006, p. 6).

4  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 (OJ L 334, 12.12.2008, p. 7).

 
Annexes 

55

I
x
e
n
n
A

International initiatives on preparedness planning and transparency

5.  There are also several other international initiatives addressing the need to enhance preparedness planning 
and increase transparency. These initiatives mainly include the Global Health Security Agenda5 initiative 
to perform ‘peer reviews’6 and the G7 and Global Health Security Initiative7 support to these activities8, as 
well as ECDC country visits that occur on a voluntary basis and where preparedness is also addressed9 . The 
report on the conference10 ‘Lessons learned for public health from the Ebola outbreak in west Africa — how 
to improve preparedness and response in the EU for future outbreaks’, which fed into the Council conclu-
sions of December 2015, included the following recommendation: ‘A peer-review mechanism could help 
Member States to improve their national preparedness plans taking into account past and current initiatives 
on independent country evaluations on global and regional level.’

5 

6 

7 

8 

9 

‘The Global Health Security Agenda (GHSA) was launched in February 2014 and is a growing partnership of nearly 50 nations, international 
organisations, and non-governmental stakeholders to help build countries’ capacity to help create a world safe and secure from infectious disease 
threats and elevate global health security as a national and global priority. GHSA pursues a multilateral and multi-sectoral approach to strengthen 
both the global capacity and nations’ capacity to prevent, detect, and respond to human and animal infectious diseases threats whether naturally 
occurring or accidentally or deliberately spread.’ (https://ghsagenda.org).
‘A self-assessment and an external assessment conducted by a team of experts from other GHSA countries. This peer-to-peer model ensures an 
objective approach and facilitates cross-border learning. GHSA external assessments should be conducted at least twice for each country, once to 
establish a baseline measurement and, subsequently, to identify progress made.’ EU Member States that have already participated and for which 
a report has been published are Portugal and the United Kingdom.
‘The Global Health Security Initiative (GHSI) is an informal, international partnership among like-minded countries to strengthen health 
preparedness and response globally to threats of biological, chemical, radio-nuclear terrorism (CBRN) and pandemic influenza. This initiative was 
launched in November 2001 by Canada, the European Union, France, Germany, Italy, Japan, Mexico, the United Kingdom and the United States. The 
World Health Organisation serves as an expert advisor to the GHSI’ (http://www.ghsi.ca/english/index.asp).
‘In order to prevent future outbreaks from becoming large-scale public health emergencies, the G7 leaders have agreed to offer to assist at least 
60 countries, including the countries of west Africa, over the next 5 years to implement the IHR, including through the Global Health Security 
Agenda (GHSA) and its common targets and other multilateral initiatives’, Declaration of the G7 Health Ministers, 8 and 9 October 2015, Berlin.
ECDC Technical Report, ‘Ebola emergency preparedness in EU Member States: conclusions from peer-review visits to Belgium, Portugal and 
Romania’, June 2015.

10  High level conference organised by DG Health and Food Safety on 12 to 14 October 2015 in Mondorf-les-Bains, Luxembourg.

 
Annexes 

56

Description of main roles and responsibilities in the EU framework for protecting 
citizens against serious cross-border threats to health

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Member State public health authorities

1.  Member State public health authorities are responsible for public health policy at national level, and for 
dealing with public health threats. Differences in responsibilities for certain aspects of preparedness and 
response planning and early warning and response might exist between Member States, involving different 
public authorities, depending on their government organisation, national risks or specific situations. Some 
Member States may have decentralised parts or most of the public health responsibilities, including those 
for preparedness and response planning. EU Member States are also members of the WHO Europe Region1 
and have an obligation to implement the International Health Regulations as explained in Annex I.

2.  Since the adoption of Decision No 1082/2013/EU, Member States also have an obligation to provide certain 
information on their preparedness and response planning to the Commission. Decision No 1082/2013/EU 
requires Member States and the Commission to consult each other in the Health Security Committee to 
develop, strengthen and maintain their capacities for the monitoring, early warning and assessment of, and 
response to, serious cross-border threats to health. That consultation is aimed at sharing best practice and 
experience in preparedness and response planning; promoting the interoperability of national prepared-
ness planning; addressing the intersectoral dimension of preparedness and response planning at Union 
level; and supporting the implementation of core capacity requirements for surveillance and response 
as referred to in the IHR. Member States also appoint national competent authorities for epidemiological 
surveillance that are responsible for delivering data to the European surveillance system in accordance with 
EU rules and guidance, and nominate national EWRS contacts to monitor EWRS and notify alerts, under the 
rules set out in the decision.

European Commission — DG Health and Food Safety

3.  The Commission ensures the secretariat and presidency of the Health Security Committee and coordinates 
and operates its Health Emergency Operations Facility (HEOF). It also manages relevant IT systems and co-
ordinates with other Commission services and agencies for cross-cutting issues in this policy area, as well as 
with relevant international organisations, such as WHO. Decision No 1082/2013/EU on serious cross-border 
threats to health specifically provides that the Commission (i.e. DG Health and Food Safety), in liaison with 
the Member States, ensures coordination and exchange of information between the mechanisms, structures 
and activities which are relevant to preparedness and response planning, monitoring, early warning of and 
combating serious cross-border threats to health. The Commission is also responsible for ensuring that any 
duplication of activities or conflicting actions is avoided, and that adequate resources are made available for 
all its required and critical tasks and functions.

1  Covering a total of 55 countries reporting to the WHO Regional Office Europe in Copenhagen. 

 
Annexes 

57

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European Centre for Disease Control and Prevention (ECDC)

4.  ECDC operates and coordinates the network for epidemiological surveillance of communicable diseases and 
of antimicrobial resistance and healthcare-associated infections related to communicable diseases. It is an 
EU agency with the mission to identify, assess and communicate current and emerging threats to  human 
health posed by infectious diseases. ECDC also hosts the operation of the Early Warning and Response 
System (EWRS). EWRS is a web-based system linking the Commission, public health authorities in Member 
States responsible for measures to control communicable diseases and ECDC. EEA countries (Iceland, Liech-
tenstein and Norway) are also linked to the system and WHO has read access.

5.  Under the decision on serious cross-border threats to health, ECDC is required to provide scientific advice 
and risk assessments concerning threats that are alerted through the EWRS, in particular for threats of bio-
logical or unknown origin. Other EU agencies or bodies (e.g. scientific committees) might be requested by 
the Commission to provide rapid risk assessments when their expertise is closer linked to the type of threat 
at hand. When requested, ECDC further assists the Commission and the Member States in implementing 
Decision No 1082/2013/EU requirements for preparedness planning. The annual budget of ECDC also cov-
ers disease programmes; these are vertical programmes for specific diseases, which also have components 
such as capacity building and risk communication. ECDC can provide outbreak response support to coun-
tries or international organisations like WHO, as it did during the Ebola outbreak. It operates an emergency 
operations centre, based on a public health emergency manual. The current ECDC approach is to target all 
hazards (i.e. not just threats to health from communicable diseases, but also from other origins), aligned 
with the objectives of the IHR and Decision No 1082/2013/EU. This is beyond ECDC’s previous, traditional 
mandate that focused on communicable diseases and pandemic preparedness. 

 
Annexes 

58

I
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Overview of audited co-funded actions

The following table provides a list with key features of the audited actions, co-funded under the health threats 
objective of the second EU health programme 2008-2013, managed by Chafea or DG Health and Food Safety (for 
three procurement items).

Ref.

General description

Funding instrument

EU co-funding as per grant 
agreement
(euro)

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

Developing a generic framework for the fast production and evaluation 
of emergency vaccines

Optimising testing and linkage to care for HIV across Europe

A network for the control of public health threats and other bio-securi-
ty risks in the Mediterranean region and Balkans

Project

Project

Project

Screening for Hepatitis B and C among migrants in the European Union

Project

Syndromic surveillance survey, assessment towards guidelines for 
Europe

Public health adaptation strategies to extreme weather events

Empowering civil society and public health system to fight tuberculosis 
epidemic among vulnerable groups

Cost-effectiveness assessment of European human influenza pandemic 
alert and response strategies

A European network on cervical cancer surveillance and control in the 
new Member States

Promotion of Immunisation for health professionals in Europe

Coordinated action in the aviation sector to control public health 
threats

Promote vaccinations among migrant populations in Europe

Alerting, Surveillance and Reporting System for Chemical Health 
Threats, Phase III

European Chemical Emergency Network

Project

Project

Project

Project

Project

Project

Project

Project

Project

Project

Quality assurance exercises and networking on the detection of highly 
infectious pathogens

Joint action

Command post exercise on serious cross-border threats to health falling 
under the chemical and environmental categories

Procurement/service 
contract

Organisation of two regional training seminars with Member State 
public health authorities relating to the implementation of the new 
decision on serious cross-border threats to health.

Procurement/service 
contract

Early alerting and reporting system, Hedis, Nemo (monitoring informa-
tion exchange mechanisms for crisis management)

Procurement/service 
contract

The European reference laboratory system for human pathogens

Procurement/service 
contract

Organisation of training of staff and conducting exercises at European 
level as a fundamental element of preparedness

Procurement/service 
contract

2 116 023

1 429 984

900 000

800 000

798 814

750 000

750 000

700 000

615 023

604 000

598 566

548 680

497 760

447 600

3 316 326

458 989

249 599

1 588 500

500 000

333 646

Total :

18 003 510

 
Annexes 

59

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The following table provides a list with key features of the reviewed actions, co-funded under the seventh 
framework programme for research (FP7) 2008-2013.

Ref.

General objective of the selected 
action

Funded under FP7 
programme

Responsible 
Commission service

EU co-funding
(euro)

1

2

3

4

5

6

7

8

9

10

Forecasting epidemic evolution and 
pandemic simulations

Platform for emerging and re-emerging 
infectious disease entities

Infection control in aviation, ranging 
from effective quarantine to protocols for 
sanitizing/decontaminating the airliner 
cabin

To develop an evidence-based behaviour-
al and communication package for health 
professionals and agencies throughout 
Europe in case of major outbreaks

ERC1

HEALTH

PEOPLE

HEALTH

The role of pharmaceutical companies in 
the formulation and implementation of 
health security policy

ERC

ERCEA

RTD

REA

RTD

ERCEA

Transform Europe’s response to future 
severe epidemics or pandemics by 
providing infrastructure, coordination and 
integration of existing clinical research 
networks

Create an integrated toolbox to aid 
transport operators and relevant actors in 
major transport hubs in the development 
of their current pandemic and dangerous 
pathogen preparedness and response 
plans

Interoperability and preparedness of 
European health services in relation to 
deadly threats such as pandemic disease 
and major terrorism attack

To increase preparedness to large-scale 
and cross-border disasters amongst com-
munities and societies in Europe.

To address effectively scientific and soci-
etal challenges raised by pandemics and 
associated crisis management. To develop 
an integrated, transdisciplinary, strategy.

HEALTH

RTD

SEC2

SEC

SEC

SiS3

HOME

REA

REA

RTD

Total :

1  European Research Council.
2  Security programme.
3  Science in Societies.

684 000

11 909 560

100 000

1 999 607

1 197 694

23 992 375

3 142 004

2 789 940

999 084

3 939 880

50 754 144

 
Reply of the  
Commission

Executive summary

60

III
The decision on serious cross-border threats to health is based on Article 168 of the Treaty, the public health article. 

V
The Commission and Member States are working to put in place the infrastructure required to fully and effectively 
implement the decision on serious cross-border threats to health. This is a complex matter. While it is acknowledged 
that there have been delays, for example, in adopting certain implementing acts, these delays are being addressed 
and did not weaken significantly the effectiveness of the EU response to cross-border health threats. Both Member 
State and Commission responsibilities are clearly defined in Decision No 1082/2013/EU.

VI
The delays in implementing the decision on serious cross-border threats to health are a reflection of the complex-
ity of the health threats situation or ‘complexity of the subject matter’. As set out in the detailed comments below, 
important progress has been made in preparing the remaining implementing acts and in advancing the work on 
medical countermeasures. The joint procurement mechanism is now fully established. The Health Security Com-
mittee is fully operational; the Commission will discuss the Court's observation with the Member States in the 
Committee. 

VII
The Commission considers that despite technical upgrades of the system over time, it is desirable to modernise the 
system. The Commission is currently working with ECDC to modernise the EWRS system. 

IX
The Commission considers that good coordination is in place between Commission departments dealing with vari-
ous aspects related to health security and the specific points raised by the Court are being addressed. DG Health 
and Food Safety took important steps in 2016 to improve the operation of the Health Emergencies Operations Facil-
ity (HEOF). 

X 
(i)
The Commission accepts Recommendation 1 and agrees as far as its role in the HSC and in the joint procurement 
mechanism is concerned. It will discuss these matters in the HSC.

(ii)
The Commission accepts Recommendation 2. The Commission is currently working with ECDC to modernise the 
EWRS system and will discuss with the Member States how user feedback can enhance the functioning of the 
system.

Reply of the Commission 

61

(iii)
The Commission accepts Recommendations 3(a) and (c) and partially accepts Recommendation 3(b). 

The Commission recognises that sustainability is a pending issue although much has been done in recent years. 
Continuous improvements are being made especially in the framework of the action plan established by the Com-
mission following the evaluation of the second health programme. 

(iv)
The Commission partially accepts Recommendation 4(a) and accepts Recommendations 4(b) and (c). Good 
co operation between the respective Commission services is in place and discussions between services are under 
way to further develop coordination. 

The Commission considers that the structure of the HEOF is stable and defines the roles and alert levels. From June 
2016, the Commission has developed a continuous training programme to ensure the full operability of the HEOF at 
any moment. 

Audit observations

21
The decision on serious cross-border health threats represents an important step forward in enhancing cooperation 
of Member States to improve the response to heath threats and the protection of EU citizens. 

The Commission is aware that certain delays occurred but considers that they have not put into question the effect-
ive cooperation of Member States on serious cross-border health threats.

24
As health security preparedness covers sensitive fields, the reporting template was discussed thoroughly with the 
Member States and a second comitology meeting was necessary to reach an agreement. 

Reply of the Commission 

62

25
The report submitted to the HSC did not include individual information from the Member States as health security 
preparedness covers sensitive fields. The report is based only on Member States’ input given that the legislation 
does not mandate the Commission to verify and check information provided by Member States. 

The results of the report were further discussed within the Working Group of the HSC on Preparedness and 
Response Planning (12 November 2015). At the plenary meeting of the HSC (7 and 8 June 2016) Member States were 
informed about an updated report reflecting in detail key problems in each Member States. 

26
The Commission considers that the progress report provides a comprehensive overview on the state of national pre-
paredness in the EU and delivers clear orientations as to how the gaps and shortcomings can be addressed through 
an action plan agreed with Member States through endorsement by the HSC. The subgroup on preparedness of the 
HSC will continue its discussions on how the findings of the report are followed up in combination with the lessons 
learned from the Ebola outbreak. A first audio meeting of this group took place prior to the HSC in November 2015.

Discussions and work with ECDC and WHO/Europe are ongoing to review the reporting template under Article 4, 
considering the WHO approach to IHR implementation and the new monitoring and evaluation framework.

Box 3 — International developments concerning preparedness: weaknesses in self-
assessment of IHR implementation 
This box refers to developments within WHO which are outside the EU legal framework.

27
As explained above, Member States were actively involved in drafting the questions and the comitology procedure 
reached the required qualified majority.

28
The decision on serious cross-border threats to health does not confer any powers on the Commission to impose 
a particular generic preparedness structure on Member States. The strategy for generic preparedness planning 
mentioned by the Court is a technical document which forms part of the background of the ongoing work with 
Member States on preparedness. Within the Member States, it is particularly up to the HSC members to disseminate 
the existing guidance.

Reply of the Commission 

63

29
The procedures are complex both from a legal perspective, in view of EU competence in health which is to support, 
coordinate or supplement actions of the Member States in the area of public health, but also due to the multitude 
of actors and complex structures in place within countries and in relation to international structures working on 
these topics. 

The Commission considers that the information gathered under the reporting exercise of Article 4 of the decision 
on serious cross-border threats to health provides a comprehensive review on the state of national preparedness in 
the EU and provides clear orientations about how the gaps and shortcomings can be addressed. The subgroup on 
preparedness of the HSC is taking this further.

30
The Commission is working closely with Member States in the HSC and its preparedness working group to develop 
the structures and arrangements on cooperation on preparedness, including an action plan, cooperation on med-
ical countermeasures and reporting under Article 4 of the decision on serious cross-border threats to health. This 
will include a discussion on reporting on progress. 

31
As the objective and indicator are not included in the decision on serious cross-border threats to health, the Com-
mission has developed other ways of reporting in cooperation with ECDC, as outlined in paragraph 33.

33 ECDC's assessment is based on the responses to the reporting exercise under Article 4 of the decision on serious 
cross-border threats to health. This is a technical assessment fully in the remit of ECDC. 

The Commission is discussing with ECDC the development of suitable indicators to confidently measure progress on 
preparedness. 

The development of new indicators is part of the wider approach of developing country health profiles, in discus-
sion with ECDC, WHO /Euro and Member States in the preparedness working group. 

34
As part of the work on preparedness, the Commission will discuss the appropriateness of indicators with the Mem-
ber States in the HSC. The ECDC report provides a technical overview of the situation, gaps and needs in Member 
States regarding preparedness and response planning.

Reply of the Commission 

64

37
The Commission considers that day-to-day cooperation on serious health threats, such as the Zika virus outbreak, 
demonstrates that the division of tasks is understood and that ECDC is able to fully play its role in providing risk 
assessment information to the HSC. The distinction between risk assessment (ECDC’s responsibility) and coordina-
tion of risk management (the Commission’s responsibility) is set out in the legislation. Specific cases and new tasks, 
however, often need to be discussed and agreed between the Commission and ECDC on a case-by-case basis. To 
this end, the monthly coordination meetings between ECDC and the Commission ensure close cooperation and 
enable ECDC to respond effectively to requests for assistance.

39
The work on the development of the guide dates from before the adoption of the decision.

Following the adoption of the decision, the Commission has suggested to ECDC that discussions be held with the 
HSC on the guide and its recommendation. Following further work on the document, a discussion is foreseen in the 
HSC preparedness working group in autumn 2016. 

40
The subsequent steps to develop the joint procurement agreement in the framework of the decision on serious 
cross-border threats to health were undertaken without undue delay; it has to be considered that individual Mem-
ber States had to comply with national ratification procedures to sign the agreement, which inevitably takes a cer-
tain time. 

41
The procurement of influenza pandemic vaccine is an extremely complex matter. Moreover, it proved to be time- 
consuming to identify and bring together Member States’ specific requirements. At the same time, in 2016, signifi-
cant progress has been made in preparing a joint procurement procedure for pandemic vaccines. In addition to the 
procedure on pandemic vaccines, four other procurement procedures were under way as of September 2016.

42
The Commission would like to point out that both joint procurement and a more developed procedure on exchang-
ing medical countermeasures have their place in preparedness for serious cross-border health threats. By its nature, 
any procurement will take time and will require following procedures set out in EU legislation. 

With the mandate of the HSC, standard operating procedures are currently being developed with the aim to ensure 
a rapid and consistent response in future emergencies. The outcome of the discussion will be presented to the HSC 
in November 2016. 

In any case the Civil Protection Mechanism already provides a framework for the exchange of countermeasures.

Reply of the Commission 

65

43
While progress on the joint procurement of influenza vaccines has indeed been slow due to the complexity of 
the matter, the Commission would point out that 24 Member States have agreed so far to participate in the joint 
procurement agreement and that a number of joint procurement processes are currently ongoing. Urgent needs 
for the exchange of medical countermeasures can always be handled through the EWRS (as done e.g. for diphtheria 
antitoxin in 2016) or in general through the Civil Protection Mechanism. 

46
So far, the HSC has decided not to establish a working group on migrants. The need for such a working group will 
be discussed again in an HSC workshop.

When operational topics returned to the HSC agenda after February 2015, HSC meetings were thematically organ-
ised and a detailed roadmap for the HSC is under preparation. The action plan on preparedness will further provide 
a framework for a work plan of the preparedness working group. In addition, discussions with ECDC are ongoing in 
order to better coordinate the work of the ECDC Coordination Committee on Preparedness and the preparedness 
working group under the HSC. Work on establishing work plans has commenced with both the communicators net-
work and the preparedness working group. 

47
As of September 2016, 11 Member States, WHO and ECDC participated in the working group on preparedness. 
The working group is important to prepare documents for the HSC, such as the standing operating procedures on 
medical countermeasures and the action plan on preparedness, etc. A full participation is less important here as the 
working group brings together technical experts to prepare proposals for endorsement/acknowledgement by the 
full HSC.

48
The tasks of the HSC are listed in the decision on cross-border threats to health (Article 17, paragraph 2). HSC meet-
ings were thematically organised and a detailed roadmap for the HSC is under preparation (see paragraph 46). 
In order to coordinate responses, technical documents, such as risk assessments produced by ECDC and relevant 
traveller's advice, are discussed during the ad hoc meetings of the HSC. However, in case of technical discussions, 
relevant ad hoc working groups can be convened based on the decision of the HSC, composed of technical experts 
from Member States. This was the case during the current Zika outbreak, when the ad hoc working group on the 
Zika virus outbreak was set up and convened two times. 

Reply of the Commission 

66

51
The Commission agrees that when the entry into force of the decision on serious cross-border threats to health 
coincided with the Ebola crisis, efforts to develop a more structured approach, in particular towards preparedness, 
were delayed. This work is however now well under way.

52
The Commission considers that the information it provides to the HSC in relation to activities of relevant Commis-
sion departments is adequate. Cooperation arrangements between departments are in place. Participation of other 
services in the HSC meetings is frequent. Additionally, DG Health and Food Safety also participated, for example, in 
the daily audio conferences of the Ebola task force and in many other interservice groups.

60
The ECDC external evaluation report referred to a period between 2008 and 2012, before the decision on serious 
cross-border threats to health entered into force and before the corresponding (limited) modifications of the EWRS 
took place. 

63
The Commission agrees that user feedback is essential in the review of the EWRS. 

64
The Commission is working with ECDC to reshape the system.

65
The Commission highlights that the list referred to in this paragraph was identified in the impact assessment pre-
pared in advance of the actual decision.

67
The Commission has commenced work with ECDC to reshape the EWRS system. 

70
Rules and procedures for dealing with chemical and environmental threats in the framework of the decision on 
serious cross-border threats to health are the same as for the other threats caused by biological events or commun-
icable diseases. Notification criteria are the same as well as the use of the IT tool designed for this purpose. A spe-
cific network for the monitoring and assessment of events due to chemical and environmental threats was co-
founded 3 years ago under the health programme. A link with the European Commission Scientific Committee has 
also been established to ensure that sufficient expertise for risk assessments outside the ECDC mandate can be 
recruited. 

The functioning of the system will be tested in a future exercise. 

Reply of the Commission 

67

72
The Commission is moderating and maintaining the system but the intention is to integrate RASCHEM into EWRS. As 
of September 2016, 18 countries were registered with RASCHEM.

74
The Commission is aware and is working with ECDC to improve the data quality and completeness of the Member 
State reporting.

77
The Commission is aware and is working together with ECDC to increase the data quality and completeness of the 
Member States reporting. 

78
The Commission notes that the Court has examined activities under the second and third health programmes. 
The management of the programme has significantly changed between the two programmes. The calls for tender 
funded from the health programme have actively contributed to improving the cross-border preparation against 
health threats and most projects delivered results as planned. 

The cross-country exercises funded from the health programme have actively contributed to improving the cross-
border preparation against health threats.

81
The Commission is well aware that the sustainability of results has not always been satisfactory for some projects 
co-funded under the second health programme before Decision No 1082/2013/EU came into place. A minimum of 
sustainability is always ensured through the dissemination of the projects’ results and their sustained availability on 
Chafea’s website. Recently improvements have been made: the new database will be launched on Chafea’s website 
in mid November 2016; a new IT platform (providing the possibility to host projects’/joint actions’ websites dur-
ing and after the end of grants) is under development; Chafea has prepared a model dissemination strategy to be 
provided to project coordinators. 

Box 5 — Examples of audited projects and issues found
The Commission is aware that not all projects perform equally and to the highest quality possible. To ensure that 
each project performs at the highest possible level, Chafea has for several years put measures in place such as pro-
viding ‘at risk’ projects with external expertise and coaching.

The Commission considers that the action plan established by the Commission and Chafea after the ex post evalua-
tion of the second health programme will ensure that only actions with a high possibility of contributing to impor-
tant EU policy initiatives and high EU added value are co-funded in order to minimise the risk of low performance 
and uptake of the results.

Reply of the Commission 

68

82
Besides the written files, Chafea also informs the Commission in bilateral meetings about important project results. 
In addition, since mid-2016 Commission staff have had access to the new IT system Chafea uses for project manage-
ment. This system was not in place for the projects audited.

As already mentioned above (under paragraph 81), Chafea has prepared a model dissemination strategy that will 
help project coordinators in their work in this field. Chafea engaged recently a full-time dedicated dissemination 
officer to — inter alia — support health project coordinators in their dissemination tasks.

83
Further to the ex post evaluation of the second health programme, the Commission, in collaboration with Chafea, 
has developed an action plan to implement all recommendations made by the external evaluators. Progress is being 
made, for example by revamping the public database, defining monitoring indicators and setting up a monitoring 
system and developing a dissemination strategy. 

Box 6 — Joint actions under the health programme
The Commission considers that joint actions are an important instrument to facilitate the cooperation of Mem-
ber State authorities on specific technical issues, which has proven to be effective in the health threats area. Joint 
actions are supplemented in particular by activities (e.g. exercises) funded through procurements.

84
The outcomes of exercises and training regularly feed into preparedness work; most recently, the HSC received 
information on lessons learnt from exercises in its June 2016 meeting. 

85
Certain tools developed by the JRC for modelling are still in existence and are being used inter alia by ECDC. Discus-
sions are under way to strengthen cooperation between ECDC and the JRC on the basis of these tools. 

86
The Commission considers that actions taken could be more structured. However, there are actions taken such as 
project coordinators being invited to expert group meetings (such as the EWRS, FLU, GPP, chemical threats) and/or 
HSC meetings or a workshop in December 2014 on ‘How to benefit from European projects: an EU Member State ini-
tiative to disseminate the results of the second EU health programme (2008-2013) in the health security area’ (http://
ec.europa.eu/chafea/news/news349.html). 

87
The Commission, when using procurement contracts, purchases services for which its follow-up actions depend on 
the kind of service delivered. Moreover, results of the procured services, mostly available in the form of a report, are 
published and available for a sufficiently long period. 

The Commission takes several actions in order to increase the diversity of contractors such as having framework 
contracts with reopening of competition.

Reply of the Commission 

69

88
The Commission recognises that sustainability is a pending issue although much has been done in recent years, 
such as the production of the generic preparedness planning (GPP) brochure (2011)1, the cluster meeting on vac-
cination (2012), the High Level Health Programme Conference (2012)2 and the Regional Health Security Conference 
(2014)3. A minimum of sustainability is always ensured through Chafea’s website. Continuous improvements are 
being made (see comment under 81). 

89
The action plan developed by the Commission after the evaluation of the second health programme includes the 
development of new monitoring indicators. These are being used in a new monitoring system which beneficiaries 
have been including in their periodic reporting since 2016. This monitoring will also help to measure the contribu-
tions of co-funded action to the overall third health programme objectives.

91
The Commission highlights that the multiannual planning is an informal and internal process. It is not legally man-
datory under the third health programme. 

92
Forecasts on budget implementation are only indicative. The priority on risk assessment is, for example, only rele-
vant for emergencies. If no such emergency occurs, the work programme for this priority could be implemented 
without any spending. Moreover, this does not mean that the budget distribution is unbalanced.

93
The ex post evaluation of the second health programme and the Commission’s action plan of March 2016 point to 
the development of a new monitoring system and indicators applicable starting from 2016.

94
The monitoring system and indicators are currently being improved with some new indicators already applicable 
from 2016.

When the Commission forecasts the budget implementation, achieving a balance between the objectives of the 
programme is not a goal. 

1  http://ec.europa.eu/chafea/publications/publications_for_health_programme.html#

2  http://ec.europa.eu/health/programme/events/ev_20120503_en.htm

3  http://ec.europa.eu/chafea/news/news349.html

Reply of the Commission 

70

95
The Commission considers that it has put in place structured cooperation between departments.

101
The Commission considers that a good structured cooperation between departments is already in place. This can 
always be improved, which may include further mapping of activities. However, this will not in itself address the 
issues relating to the uptake of research results.

102
The Commission is committed to further develop the good cooperation between departments and considers that 
there is room for improvement. Thanks to the diverse measures in place, such as the memorandum of understand-
ing with several DGs, and the regular meetings and other ways of exchanging information effectively and effi-
ciently, the cooperation is adequate.

Common Commission reply to paragraphs 103 to 106
During the most recent crises, the Commission considers that the ERCC has demonstrated that it plays an effective 
role as central convening platform, as entry point for the IPRC and in coordinating the response to disasters outside 
the Union.

107
Indeed, the lessons learned from the H1N1 outbreak in 2009/2010 led to a substantial simplification of the structure 
of the HEOF, which has been stable since then. Moreover, major exercises and training lead to an update of the 
handbook if deemed necessary. 

108
The Commission acknowledges that a continuous programme for training and exercises is a good means to keep up 
and strengthen knowledge that can be recalled easily when the HEOF is activated. 

Following the reorganisation of DG Health and Food Safety in early 2016, HEOF training for all staff concerned has 
been developed and started being delivered. Training sessions are organised at regular intervals. 

Staff have been assigned to cover the predefined HEOF roles. This allows better familiarisation and more focused 
training with regard to the respective roles.

109
The Commission is of the opinion that the HEOF proved to be functional in past crisis situations, considering the 
limited number of staff operating under the HEOF. The current HEOF structure was defined following the lessons 
learned from the H1N1 outbreak in 2009/2010. The Commission considers that the structure is stable and defines 
the roles and alert levels. At the time of the Ebola outbreak, staff concerned in DG Health and Food Safety were 
well aware of the procedures. More recently, the HEOF operations were reviewed and training provided to staff 
concerned.

Reply of the Commission 

71

111
The Commission recalls that, given the historical development, emergency response procedures within the Commis-
sion are quite diverse and have been set up in different manners and with different staff schemes to meet individual 
challenges. This also applies to ECDC, which runs, for example, a 24/7 availability roster even during peace time. 

Conclusions and recommendations

115
The decision on serious cross-border health threats represents an important step forward in enhancing cooperation 
of Member States to improve the response to heath threats and the protection of EU citizens. 

The Commission is aware that certain delays occurred but they have not put into question effective cooperation of 
Member States on serious cross-border health threats.

116
The Commission recognises certain delays in establishing effective cooperation of Member States on serious cross-
border health threats.

The state of national preparedness in the EU and the gaps and shortcomings will be addressed through an action 
plan agreed with Member States through endorsement by the HSC. 

Discussions and work with ECDC and WHO/Europe are ongoing to review the reporting system considering the 
WHO approach to IHR implementation and the new monitoring and evaluation framework.

117
The Commission considers that ECDC´s role is defined in its founding regulation and in the cross-border decision.

Preparations for a joint procurement procedure for pandemic vaccines have been well advanced in 2016. Further 
joint procurement initiatives are under way.

The civil protection mechanism already provides for the exchange of countermeasures, and a specific SOP for medi-
cal countermeasures is being developed.

The HSC proved to be an effective coordination mechanism for Member States.

118
The governing body of the JPA is the JPA Steering Committee. 

Reply of the Commission 

72

Recommendation 1  
(a)
The Commission accepts the recommendation; it will discuss this recommendation and the potential scope and 
content of a roadmap with the HSC. Depending on the outcome of the discussion, the Commission will prepare such 
a document for endorsement by the HSC.

(b)
The Commission accepts this recommendation.

(c)
The Commission accepts this recommendation.

The working groups are important tools for the HSC. They develop results based on specific tasks as an input to the 
HSC. The Commission does not accept that 2017 should be the end point of their activities, but rather sees pre-
paredness and communication as ongoing tasks where the maintenance of specific working structures would be 
justified.

(d)
The Commission accepts, as far as its role and responsibilities in the joint procurement mechanism is concerned. 

119
The Commission agrees that despite technical upgrades of the system over time, it is desirable to modernise the 
system. Discussions are ongoing with ECDC.

Recommendation 2  
(a)
The Commission accepts this recommendation. The Commission is currently working with ECDC to modernise the 
EWRS system.

(b)
The Commission accepts this recommendation and will discuss with the Member States how user feedback can 
enhance the functioning of the system. 

120
The Commission recognises that sustainability is a pending issue although much has been done in recent years, 
such as the production of the generic preparedness planning (GPP) brochure (2011), the cluster meeting on vac-
cination (2012) and the Regional Health Security Conference (2014). Continuous improvements are being made, 
most recently the revamping of the public database, the HELI platform, and implementing the new dissemination 
strategy.

The performance monitoring system is currently being improved with some new indicators already applicable since 
2015.

Reply of the Commission 

73

Recommendation 3  
(a)
The Commission accepts the recommendation. All aspects are already addressed in the action plan that the Com-
mission drafted in 2016 further to the ex post evaluation of the second health programme. DG Health and Food 
Safety will continue to cooperate with Chafea on the issue of policy relevance of ongoing and recently completed 
actions. 

(b)
The Commission partially accepts the recommendation and will discuss reporting with the Member States in the 
HSC. An effective implementation of this recommendation depends on the Member States.

(c)
The Commission accepts the recommendation and already addresses it in its multiannual planning exercise for the 
years 2018-2020, which should be finalised in autumn 2016 to plan the priorities for the third health programme for 
these years.

Recommendation 4 
(a)
The Commission partially accepts this recommendation.

The Commission considers that a good structured cooperation between departments is already in place. This can be 
improved, which may include further mapping of activities. However, this will not in itself address the issues relating 
to the uptake of research results.

(b)
The Commission accepts the recommendation to further develop the good cooperation between departments. 

(c)
The Commission accepts this recommendation. Following the lessons learned from the H1N1 outbreak in 2009/2010, 
the HEOF has been significantly simplified and reorganised. The Commission considers that the structure as it 
stands today is stable and defines the roles and alert levels. From June 2016, a continuous training programme 
has been developed and training sessions are organised at regular intervals. Still ongoing are discussions on 
a sustain able long-term solution for compensation of staff who participate in the management of public health 
emergencies.

After Ebola and in light of needs to address environmental and chemical threats, several exercises were organised 
identifying further improvement needs. Work with ECDC is under way.

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Event

Adoption of the Audit Planning Memorandum/Start of audit

Official sending of draft report to Commission (or other auditee)

Adoption of the final report after the adversarial procedure

Commission’s (or other auditee’s) official replies received in all languages

Date

15.7.2015

22.7.2016

5.10.2016

14.11.2016

 
A key milestone in building a stronger EU health security 
framework was the adoption in 2013 of a decision on 
serious cross-border threats to health. The EU health and 
research framework programmes also support actions 
related to this framework. The audit found that the decision 
on serious cross-border threats to health indeed represents 
an important step for dealing better with such threats in the 
EU, but that significant weaknesses affect the 
implementation of the health security framework. More 
needs to be done to address these weaknesses for the 
Union to get full benefit from the established mechanisms. 
The Court therefore makes a number of recommendations 
mainly aiming at accelerating and strengthening the 
implementation.

EUROPEAN
COURT
OF AUDITORS