REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Report on the implementation of 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
Date: 2015-12-07
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: cross-border cooperation, disease prevention, epidemiology, health control, health risk, infectious disease, information system

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 7.12.2015  COM(2015) 617 final   REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Report on the implementation of 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  
 
 
Contents 

1.  Executive summary ....................................................................................................................... 3 

2.  The implementation activities and their key achievements ....................................................... 4 

2.1.  Health Security Committee .................................................................................................. 4 

2.2. 

Preparedness and response planning ................................................................................... 4 

2.3. 

Joint procurement of medical countermeasures ................................................................. 6 

2.4.  Epidemiological surveillance ................................................................................................ 6 

2.5.  Early warning and response ................................................................................................. 7 

2.6.  Alert notification and public health risk assessment .......................................................... 8 

2.7.  Coordination of response ...................................................................................................... 9 

2.8.  Emergency situations .......................................................................................................... 10 

2.9.  Designation of national authorities and representatives .................................................. 10 

3.  Conclusions .................................................................................................................................. 10 

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1.  Executive summary 

This  report  is  intended  to  inform  the  European  Parliament  and  the  Council  about  the 
implementation  of  Decision  1082/2013/EU  on  serious  cross-border  threats  to  health,  adopted 
on  22  October  20131.  This  obligation  is  stipulated  in  Article  19  of  Decision  1082/2013/EU, 
which provides that the report is to be submitted by 7 November 2015, and every three years 
thereafter.  The  report  is  in  particular  to  include  an  assessment  of  the  operation  of  the  Early 
Warning  and  Response  System  (EWRS)  and  of  the  epidemiological  surveillance  network,  as 
well as information on how the established mechanisms and structures complement other alert 
systems at Union level while not duplicating them. 

Decision 1082/2013/EU, in force since 6 November 2013, has improved health security in the 
European Union and  the protection of the Union's citizens from communicable diseases, and 
other biological, chemical and environmental events. 

The preparedness of Member States as well as the mechanisms to notify an alert, assess the risk 
and  manage  a  cross-border  threat  through  the  coordination  of  response  at  EU  level  has  been 
systematically  tested  during  health events  of  comparatively  low  and  medium  severity  for  the 
EU. However, the biggest challenge has been the recent Ebola epidemic. 

In all cases, the established mechanisms and structures, namely the EWRS, the epidemiological 
surveillance  network,  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC),  and 
the Health Security Committee (HSC) have proven to operate effectively and up to the quality 
level required in case of a serious cross-border threat to health. Apart from the standard day-to-
day functioning of these structures, they have operated successfully during the Ebola outbreak, 
the  Middle  East  Respiratory  Syndrome  caused  by  coronavirus  (MERS  CoV)  and  the 
poliomyelitis threat.  

The  EWRS  has  been  instrumental  to  notify  alerts  as  well  as  measures  undertaken  by  the 
Member  States.  The  selective  exchange  functionality  was  crucial  for  the  transmission  of 
personal data to support the medical evacuation of Ebola patients from the affected countries 
into the EU. 
ECDC has been established by Regulation (EC) No 851/20042 as an independent EU agency 
responsible for, among others, providing timely risk assessment of a public health threat caused 
by communicable diseases, including options for possible public health measures.  

These  systems  have  shown  to  complement  other  EU  rapid  alert  systems  which  cover  other 
areas  (e.g.  food,  animal  health,  etc.)  but  may  have  a  severe  impact  on  public  health  without 
duplicating them. Complementarity has been ensured by upgrading the EWRS informatics tool 
to  allow  access  to  the  information  for  users  responsible  for  other  sectors  and  by  creating 
operational arrangements in order to share the notifications circulated through the EWRS with 
Commission  services  responsible  for  food  safety,  animal  health,  medical  devices  and 
medicines,  and  other  sectors  potentially  impacted  by  serious  cross-border  threats  to  health. 
Further details and examples are given later in the report. 

In accordance with Article 4(2) of Decision 1082/2013/EU, most Member States have provided 
the Commission with an update on their preparedness and response planning at national level. 
Based on the information so far received, the Commission in collaboration with ECDC and the 
WHO Regional Office for Europe (WHO EURO) compiled a synthesis progress report with the 
purpose of initiating discussion in the HSC. 

1   OJ L 293, 5.11.2013, p. 1. 
2   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 (OJ L 142, 30.4.2004, p. 1). 

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As the competence to take public health measures on serious cross-border threats lies with the 
Member States, Decision 1082/2013/EU obliges them to inform of such measures with a view 
to enhancing coordination among themselves in liaison with the Commission. During the Ebola 
outbreak, Member States exchanged information and discussed their response to the outbreak 
in  the HSC. An important  measure successfully carried out during the outbreak  has been  the 
medical evacuation to the EU of health workers infected or suspected to be infected with the 
Ebola virus. In addition, measures were put in place to facilitate entry screening of travellers 
coming to the EU from the Ebola-affected countries. 

Furthermore, while the overall communication in the HSC has been reasonably effective, there 
have  been  some  important  lessons  learned  from  the  process.  During  the  peak  of  the  Ebola 
outbreak there was a strong focus on the exchange of information while the impetus to discuss 
and coordinate response was less considerable. A major conclusion from the Ebola outbreak is 
that there is scope for improving the implementation of provisions whereby Member States are 
to co-ordinate their national responses.  

2.  The implementation activities and their key achievements 

2.1. Health Security Committee 

The HSC was set up in 2001 at the request of EU Health Ministers as an informal advisory 
group  on  health  security  at  European  level.  Decision  1082/2013/EU  formalised  the 
establishment and strengthened the role of the Committee.  

Following  the  designation  of  representatives  by  Member  States,  the  full  composition  of  the 
HSC  has  been  achieved  by  June  2014.  The  Rules  of  Procedure  adopted  on  26  June  2015 
provided  that  they  would  be  reviewed  within  six  months  in  the  light  of  the  two  draft 
Implementing Decisions to be adopted under Article 8 and 11 of Decision 1082/2013/EU. The 
HSC  is  chaired  by  a  representative  of  the  Commission,  which  also  provides  the  secretariat, 
and meets in plenary in Luxembourg on average twice a year (once in 2014 and three times in 
2015) and on an ad hoc basis through audio-meetings. Ad hoc audio-meetings are called by 
the  Commission  or  by  initiative  of  the  HSC  to  discuss  EU  coordination  of  measures  to 
respond to serious cross-border threats to health.  

At  the  plenary  meeting  on  27  February  2015,  the  HSC  agreed  to  set  up  a  permanent 
Communicators' network and a permanent working group on preparedness.  

Following  nominations  from  interested  Member  States,  a  group  of  representatives  from  the 
Member  States  was  set  up  in  April  2015  which  discussed  the  draft  Terms  of  Reference  for 
each working group during dedicated audio-conferences in May 2015. 

2.2. Preparedness and response planning 

Article 4(2) of Decision 1082/2013/EU requires Member States to provide the Commission, 
by 7 November 2014 and three years thereafter, with an update on the latest situation on their 
preparedness  and  response  planning  at  national  level.  The  information  to  be  provided  is  to 
cover  the  implementation  of  the  International  Health  Regulations  (IHR)3,  interoperability 
between  the  health  sector  and  other  sectors,  and  business  continuity  plans.  In  addition, 
according  to  Article  4(3)  Member  States  are  to  inform  the  Commission  in  a  timely  manner 
when  substantially  revising  national  preparedness  planning.  The  Commission  set  up  a 
dedicated  'EUSurvey'  website  to  allow  for  secure,  user  friendly  and  coherent  reporting  by 
means of a template laid down in Commission Implementing Decision 2014/504/EU4. As of 

3   http://www.who.int/ihr/en/ 
4   Commission Implementing Decision 2014/504/EU of 25 July 2014 implementing Decision No 1082/2013/EU 
of the European Parliament and of the Council with regard to the template for providing the information on 

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23 October  2015,  26  EU  Member  States  and  1  EEA  country5  representing  86%  of  the 
combined  EEA  population,  provided  the  requested  information  by  use  of  the  website. 
Member States who have so far not provided the requested information have been reminded 
to do so.  

information, 

in  accordance  with  Article  4(5)  of  Decision 
Based  on  the  received 
1082/2013/EU, the Commission transmitted a synthesis progress report to the HSC with the 
purpose  of  initiating  discussion.  The  structure  of  that  document  follows  the  structure  of  the 
template  annexed  to  Commission  Implementing  Decision  2014/504/EU.  The  information 
transmitted to HSC presents only aggregated data. 

The  information  provided  revealed  a  number  of  strengths  and  weaknesses.  As  regards  the 
strengths, the majority of the respondents indicated that they have implemented the IHR core 
capacities  and  that  they  involved  other  sectors  in  the  preparedness  and  response  planning 
activities covering a wide range of serious cross-border threats to health. Standard Operating 
Procedures (SOPs) are in place for the coordination between the health sector and a number of 
other  sectors  considered  critical  for  addressing  serious  cross-border  threats  to  health.  Most 
respondents replied that they tested the interoperability of sectors. 

As regards weaknesses, a number of respondents indicated incomplete implementation of the 
IHR  core  capacities.  Preparedness  and  response  planning  activities  involving  other  sectors 
was  inconsistently  reported  to  cover  other  communicable  diseases  apart  from  threats  of 
foodborne,  zoonotic  and  waterborne  origin,  or  antimicrobial  resistance.  A  number  of 
respondents reported that sectors have been identified as critical for addressing serious cross-
border  threats  to  health  without  appropriate  coordination  arrangements  including  Standard 
Operating  Procedures  in  place  for  the  collaboration  of  these  critical  sectors  with  the  health 
sector.  A  number  of  respondents  reported  that  national  business  continuity  plans  are  not  in 
place although some indicated efforts to create them, or that the existence of national business 
continuity plans is “not known”. Business continuity plans for the Points of Entry as referred 
to in the IHR were not consistently reported to be in place. 

The discussion in the HSC on the information under Article 4(5) of Decision 1082/2013/EU 
on 25 June 2015 concluded that the work to address the gaps identified in the report will be 
followed up by the working group on preparedness and response planning. 

In  their  replies  to  the  survey  Member  States  proposed  actions  that  the  Commission,  the  EU 
agencies or Member States should take to ensure that the IHR core capacities are maintained 
and strengthened in the future including regular follow-up with all Member States, training and 
exercises, sharing experiences, guidelines and procedures, and technical support and expertise 
with preparedness and response planning. 

Specific  suggestions  for  actions  that  the  European  Commission  and  EU  agencies  could  take 
include strengthening the capacity of and cooperation between EU agencies, supporting global 
initiatives towards better cooperation and coordination, including Joint Action type funding in 
Health Programmes and developing mechanisms for coordinated funding, supporting country 
twinning  activities,  country-specific  assessment  of  preparedness  and  networking  between 
countries and joint meetings, and conducting cross-border exercises. Further suggested actions 
include facilitating in-country networking of stakeholders, conducting in-country exercises and 
implementing a shared IT-platform to facilitate information flow among stakeholders. 

preparedness and response planning in relation to serious cross-border threats to health (OJ L 223, 
29.7.2014, p. 25). 

5   Decision 1082/2013/EU has been incorporated into the EEA Agreement by means of the EEA Joint 
Committee Decision 073/2015 -  paragraph 1 of Article 16 of Protocol 31 to the EEA Agreement. 

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Dedicated 'EUSurveys' on the preparedness to detect, identify, confirm and manage patients 
with suspect or confirmed Ebola Virus Disease, MERS-coronavirus patients and cases of new 
avian  influenza  strains  have  been  carried  out  at  the  occasion  of  the  EU  coordination  and 
management  of  specific  events,  which  has  shown  a  good  level  of  preparedness  of  Member 
States.  

2.3. Joint procurement of medical countermeasures 

Article  5  of  Decision  1082/2013/EU  lays  down  a  new  mechanism  for  Member  States  to 
engage in a joint procurement procedure with the Union institutions with a view to enabling 
the  advance  purchase  of  medical  countermeasures  for  serious  cross-border  threats  to  health. 
For  the  implementation  of  this  joint  procurement,  the  Commission  developed  a  framework 
agreement  laying  down  common  rules  for  practical  organisation  of  joint  procurement 
procedures – the Joint Procurement Agreement. 

On 20 June  2014, the Joint Procurement Agreement was signed between 14 Member States 
and the Commission. Since then, additional 8 Member States have signed the agreement6. At 
the time of preparation of this report, the first joint procurement procedure has been launched 
to  commonly  procure personal protective equipment needed to  treat patients  with  infectious 
diseases  with  potentially  severe  consequences.  Furthermore,  preparatory  work  for  the  joint 
procurement of pandemic vaccines is on-going.  

Overall  -  with  the  Joint  Procurement  Agreement  in  place  and  the  first  joint  procurement 
procedures  under  way–  the  implementation  of  Article  5  of  Decision  1082/2013/EU  has 
progressed well. 

2.4. Epidemiological surveillance 

Building  on  the  framework  set  up  by  Decision  No  2119/98/EC7,  Article  6  of  Decision 
1082/2013/EU  provides  a  legal  basis  for  a  network  between  the  Commission,  ECDC  and 
Member States' competent authorities for the epidemiological surveillance of communicable 
diseases and of related special health issues. The network is to be operated and coordinated by 
ECDC. 

The  adoption  of  Decision  1082/2013/EU  gave  new  impetus  to  the  EU/EEA  surveillance 
activities coordinated by ECDC.  

ECDC  has  continued  to  coordinate  EU/EEA  surveillance  through  meetings  and  bilateral 
communications  with  National  Focal  Points  for  Surveillance  and  Disease  Group-specific 
National Focal Points. Technical consultations took place on special topics such as automatic 
reporting  to  the  European  Surveillance  System  (TESSy)8,  EU/EEA  surveillance  standards, 
and EU/EEA molecular clusters. Weekly videoconferences were held between ECDC and the 
Commission.  Cross-cutting  issues  were  discussed  at  meetings  between  ECDC,  the 
Commission  and  the  Member  States.  EU  candidate  and  potential  candidate  countries  have 
been  increasingly  engaged  by  sharing  of  standards,  testing  of  TESSy  reporting  and 
participating in relevant meetings. 

6   The list of the Member States that signed the Joint Procurement Agreement can be found at: 

http://wcmcom-ec-europa-eu-
wip.wcm3vue.cec.eu.int:8080/health/preparedness_response/joint_procurement/jpa_signature_en.htm 
7   Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up 
a network for the epidemiological surveillance and control of communicable diseases in the Community 
(OJ L 268, 3.10.1998, p. 1). This decision was repealed by Decision 1082/2013/EU. 

8   TESSy is the technical platform for EU/EEA communicable disease surveillance, i.e. web-based data 

submission, data storage and dissemination and is a password-protected, fully anonymised database hosted 
by ECDC.  

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Stronger  data  feedback  and  dissemination  channels  were  established  through  the  Atlas  of 
Infectious  Diseases,  the  further  extension  of  the  Epidemic  Intelligence  Information  System 
(EPIS)9  and  its  integration  with  molecular  surveillance  for  Food-  and  Waterborne  Diseases. 
Cross-sectorial  reports,  such  as  the  one  on  antimicrobial  consumption  and  resistance  in 
humans  and  animals  were  published  in  addition  to  more  traditional  disease-specific 
surveillance  reports  and  the  cross-cutting  annual  epidemiological  report10.  Monitoring  of 
reports  on  threats  to  public  health  in  news  and  social  media  was  carried  out  using  the 
MedISys11 system. 

Data comparability across countries and data quality have remained top priorities for ECDC 
and have continued to be fostered through agreed reporting protocols, common meta-datasets, 
meticulous data validation, and proactive feedback during network meetings. New initiatives 
have  included  the  systematic  data  quality  assessment  and  feedback  through  indicators 
published  in  a  restricted  version  of  the  Atlas,  a  progressive  reduction  of  variables  to  be 
reported  to  TESSy,  and  the  pilot  collection  of  detailed  information  on  Member  State 
surveillance systems. 
The  Annex  to  Commission  Decision  2000/96/EC12  lays  down  the  criteria  for  selection  of 
communicable  diseases  and  related  special  health  issues  to  be  covered  by  epidemiological 
surveillance  within  the  epidemiological  surveillance  network.  The  Decision  as  amended 
currently provides for the list of 47 diseases and two special health issues, and Commission 
Decision  2002/253/EC13  as  amended  lays  down  specific  case  definitions  for  those  diseases 
and special health issues.  

ECDC has been enforcing the use of EU case definitions by rejecting non-compliant data or 
excluding them from analysis and reporting. 

2.5. Early warning and response 

Article 8 of Decision 1082/2013/EU extends the scope of the EWRS established by Decision 
No 2119/98/EC  beyond  communicable  diseases,  to  notifications  in  relation  to  all  serious 
cross-border threats to health within the scope of the former Decision. The EWRS is to enable 
the  Commission  and  the  competent  national  authorities  in  the  Member  States  to  be  in 
permanent  communication  in  order  to  alert,  assess  public  health  risks  and  determine  the 
measures that may be required to protect public health. 

For  that  purpose,  the  existing  IT  tool  of  the  EWRS  was  expanded  to  include  threats  of 
biological, chemical, environmental and unknown origin. The new version of this IT tool was 
put in place on 4 February 2015. Criteria to check whether an event matches the definition of 
a 'serious cross-border threat to health' were included in the reporting algorithm and a specific 
functionality to report 'information messages' was added as well as the functionality to report 
an event under the IHR provisions. The 'selective exchange' functionality has been maintained 
without modifications as it was in the IT application established by Decision No 2119/98/EC. 

9   EPIS is a web-based communication platform that allows nominated public health experts to exchange 

technical information to assess whether current and emerging public health threats have a potential impact 
in the European Union (EU). It aims to ensure transparent and timely information sharing among the 
participating public health authorities in order to detect public health threats at an early stage and facilitate 
their reporting under Decision 1082/2013/EU and the coordination of response activities.  

10   http://ecdc.europa.eu/en/publications/Pages/Publications.aspx 
11  http://medisys.newsbrief.eu/ 
12   Commission Decision 2000/96/EC of 22 December 1999 on the communicable diseases to be progressively 
covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the 
Council (OJ L 28, 3.2.2000, p. 50). 

13   Commission Decision 2002/253/EC of 19 March 2002 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 86, 3.4.2002, p. 44). 

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As the EWRS system involves the processing of sensitive data, such as health data, the new 
tool  has  been  developed  taking  due  account  of  the  provisions  of  Regulation  (EC) 
No 45/200114 and Directive 95/46/EC15. A number of recommendations based on the results 
of 'stress tests' carried out in 2013 by the Commission have been taken into account, including 
a  strict  'user-access'  policy.  Since  August  2015,  the  EWRS  access  is  granted  through  the 
European  Commission  Authentication  Service  (ECAS)  via  personalised  e-mail  and 
passwords,  although  some  Member  States  expressed  preference  for  access  through  'generic 
mailboxes'. 

In order to avoid duplication and to ensure that alert notifications under the EWRS are linked 
with  other  rapid  alert  systems  at  Union  level  the  new  EWRS  allows  access  to  other 
Commission services and EU bodies responsible for risk management and risk assessment in 
areas not specifically covered by the Public Health Directorate of the Directorate General for 
Health  and  Food  Safety  of  the  Commission.  These  areas  include  food  safety,  substances  of 
human  origin,  animal  health,  medicines  and  medical  devices,  biologicals  other  than 
communicable  diseases  (e.g.  plant  toxins),  chemicals,  environmental  threats,  health  security 
and  nuclear  and  radiological  threats.  The  links  allow  the  flow  of  information  between  the 
Commission services responsible for the above mentioned areas and the Member States health 
authorities  responsible  for  the  EWRS.  The  Commission  is  considering  a  further  upgrade  of 
the  application  that  will  in  the  medium  term  allow  more  user  friendly  functions  to  be 
developed as soon as the proposal for a full re-shape of the EWRS IT tool has been agreed 
with the stakeholders and the ECDC. 

2.6. Alert notification and public health risk assessment 

Article  9  of  Decision  1082/2013/EU  obliges  national  competent  authorities  and  the 
Commission to notify an alert in the EWRS where the emergence or development of a serious 
cross-border threat to health fulfils certain criteria. 

From  5  November  2013  until  4  September  2015,  a  total  of  168  messages  were  posted  with 
354  comments.  Of  the  remaining  messages,  90  were  alert  notifications  and  78  were 
information messages. 

The  breakdown  of  messages  by  notifying  countries  or  institution  was  as  follows:  European 
Commission 28, France 22, United Kingdom 20, Germany 12, Spain 11, The Netherlands 10, 
Norway 8, Italy 7, Greece 5, Belgium 4, Bulgaria 4, Austria 3, Czech Republic 3, Denmark 3, 
Iceland 3, Portugal 3, Sweden 3, Switzerland 3, Ireland 2, Lithuania 2, Malta 2, Slovenia 2, 
Croatia 1, Cyprus 1, Finland 1, Hungary 1, Latvia 1, Poland 1, Romania 1 and Slovakia 1. 49 
alert  notifications  were  related  to  Ebola  Virus  Disease,  13  to  measles,  9  to  influenza,  8  to 
MERS CoV, Chikungunya, rabies and meningitis, 6 to hepatitis, 5 to salmonellosis, botulism, 
dengue  and  West  Nile  virus,  4  to  poliovirus  and  legionellosis,  3  to  anthrax,  cholera  and 
diphtheria, 2 to tuberculosis, listeriosis, septicemia, mycobacterium and gastroenteritis, and 1 
to  each  of  the  following:  malaria,  shigellosis,  Hemolytic  Uremic  Syndrome  (HUS), 
paratyphoid  fever,  cryptosporidiosis,  leptospirosis,  enterovirus,  Zikavirus,  streptococcus, 
Severe  Acute  Respiratory  Syndrome  (SARS),  schistosomiasis,  cyclosporiasis,  trichinosis, 
Borna  virus,  HIV,  varicella  zoster  virus,  chickenpox,  pertussis,  norovirus,  hantavirus,  and 
louse borne relapsing fever. Two alert notifications related to threats stemming from chemical 
agents:  food  poisoning  linked  to  malathion  and  the  chemical  explosion  in  China.  One  alert 

14   Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the 

protection of individuals with regard to the processing of personal data by the Community institutions and 
bodies and on the free movement of such data (OJ L 8, 12.1.2001, p.1). 

15   Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of 
individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 
23.11.1995, p. 31). 

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notification related to a threat stemming from environmental origin: the volcanic ash cloud in 
Iceland. 

The MERS CoV and Ebola outbreaks have triggered the activation of the orange level of the 
Health  Emergency  Operation  Facility  of  the  Health  Threats  Unit  of  the  Directorate  General 
for Health and Food Safety. 

According  to  Article  10  of  Decision  1082/2013/EU,  the  Commission  is  to  make  promptly 
available  to  the  national  competent  authorities  and  to  the  HSC  a  risk  assessment  of  the 
potential  severity  of  the  threat  to  public  health,  including  possible  public  health  measures. 
This  provision  applies  where  it  is  necessary  for  the  coordination  of  the  response  at  Union 
level  and  on  the  request  of  the  HSC  or  on  the  Commission's  own  initiative.  Such  risk 
assessment  is  to  be  carried  out  by  the  ECDC  or  –  according  to  the  nature  of  the  threat  – 
another Union agency, such as e.g. the European Food Safety Authority (EFSA). 

Since  November  2013,  the  ECDC  produced  rapid  risk  assessments  for  28  events:  Ebola, 
MERS-CoV,  polio,  avian  influenza,  salmonella,  measles,  Zika  virus,  Chikungunya, 
legionellosis,  schistosmiasis,  anthrax,  healthcare  associated  infection  with  mycobacterium, 
enterovirus,  diphtheria,  louse  borne  relapsing  fever,  Borna  virus,  food  intoxication  due  to 
malathion,  chemical  explosion  in  China  and  the  floods  in  Bosnia  Herzegovina,  Serbia  and 
Croatia16.  

Rapid  risk  assessments  prepared  by  the  ECDC,  as  well  as  their  updates  when  needed,  have 
been  very well received by Member States. In  addition  'options for actions', which in  many 
cases  were  included  in  the  risk  assessments,  have  proved  useful  to  discuss  within  the  HSC 
possible measures at EU level to respond to the events, as it was the case for the main events 
notified since November 2013, namely MERS CoV, poliomyelitis in vulnerable countries and 
the Ebola epidemic in West Africa. 

2.7. Coordination of response  

According  to  Article  11  of  Decision  1082/2013/EU,  following  an  alert  in  the  EWRS,  on  a 
request  from  the  Commission  or  a  Member  State,  Member  States  are  to  consult  each  other 
within  the  HSC  and  in  liaison  with  the  Commission  with  a  view  to  coordinating  national 
responses to a serious cross-border threat to health, as well as risk and crisis communication. 
The  consultation  is  also  to  cover  national  responses  to  events  declared  a  public  health 
emergency of international concern by the WHO in accordance with the IHR. In addition, the 
Committee  is  mandated  to  reinforce  the  coordination  and  sharing  of  best  practice  and 
information  on  national  preparedness  activities.  The  Committee  further  deliberates  on 
communication  messages  to  health  care  professionals  and  the  public  in  order  to  provide 
consistent and coherent information adapted to Member States' needs and circumstances.  

In order to comply with the obligation laid down in Article 11(5) of Decision 1082/2013/EU, 
the  Commission  is  currently  preparing  an  Implementing  Decision  specifying  the  necessary 
procedures  for  the  uniform  implementation  of  the  information  exchange,  consultation  and 
coordination within the HSC. 

In the period November 2013  - September 2015, 49 ad hoc audio meetings have been called 
covering  events  and  issues  of  cross-border  relevance,  including  polio  threats  (6  audio-
meetings),  MERS  CoV  outbreaks  (2),  Ebola  epidemic  in  West  Africa  (30)17,  health  related 
aspects  of  migration  (7),  and  vaccine  shortage,  HIV/AIDS,  antimicrobial  resistance,  and  the 
state of implementation of Article 4 of Decision 1082/2013/EU. 

16   Risk assessments and guidance documents are available at: http://ecdc.europa.eu/en/Pages/home.aspx 
17   Flash reports from the plenary and audio meetings of the HSC are available at: 

http://ec.europa.eu/health/ebola/recent_developments_en.htm 

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For the Ebola outbreak, in view of its multi-sectorial character, in addition to the HSC a series 
of other tools were activated at the same time, including the Union Civil Protection Mechanism 
(upon an initial request from the WHO). The cross-sectorial coordination at Union level was 
also facilitated through the Ebola Task-Force meetings, organised in the Emergency Response 
Coordination Centre of the Commission. The HSC was useful in contributing to the task-force 
meetings  and  in  sharing  with  public  health  authorities  the  outcomes  of  these  meetings.  This 
multi-faceted  coordination  process  also  supported  the  setting  up  and  running  of  the  Union 
medical  evacuation  system  for  cases  and  suspected  cases  of  Ebola  Virus  Disease  to  Europe. 
The Common Emergency Communication and Information System (CECIS) was instrumental 
in  identifying  aerial  means,  while  the  'selective  exchange'  facility  of  the  EWRS  allowed  the 
coordination on the provision of suitable hospital treatment capacities. Through this system, so 
far,  a  total  of  16  persons  were  evacuated  to  the  EU  in  13  flights.  The  Commission  also 
contributed financially to some of these evacuation operations, with an estimated total of EUR 
1,240,000: EUR 740,000 through the Union Civil Protection Mechanism for 6 flights carrying 
8  humanitarian  workers,  and  another  EUR  500,000  from  the  humanitarian  aid  budget  for  3 
flights with 4 humanitarian workers. 

2.8. Emergency situations 

Article  12  of  Decision  1082/2013/EU  enables  the  Commission  to  recognise  a  situation 
complying with the specified criteria as a public health emergency.  

During the reporting period, there was no need to have recourse to this article since the WHO 
declared  the  outbreaks  of  Ebola  and  Polio  Public  Health  Emergencies  of  International 
Concern under the IHR. The two events matched the criteria to be reported as serious cross-
border threats to health. 

2.9. Designation of national authorities and representatives 

Article  15  of  Decision  1082/2013/EU  requires  Member  States  to  designate  competent 
authorities for epidemiological surveillance, for notifying alerts and determining the required 
measures, and the members of the HSC.  

During  the  reporting  period  designations  were  carried  out  as  required  by  Decision 
1082/2013/EU. The Commission, in collaboration with the ECDC provided uniform access to 
the EWRS to the appointed individuals by means of the ECAS.  

3.  Conclusions  

The recent Ebola epidemic has not only been a devastating crisis for the affected West African 
countries but also had significant repercussions for Europe. The initial reaction was to protect 
the  EU  and  only  later  the  attitude  changed  to  recognise  that  crucial  help  was  needed  from 
Europe  and  the  international  community  in  order  to  contain/manage  the  Ebola  outbreak  at 
source.  A  major  conclusion  from  the  Ebola  outbreak  is  that  there  is  scope  for  improving  the 
implementation  of  provisions  whereby  Member  States  are  to  co-ordinate  their  national 
responses. 

Ad-hoc  consultations  within  the  HSC  have  proven  very  useful  to  share  options  to  plan  and 
implement a coherent EU response to specific threats, although an evidence based evaluation 
on  how  the  Member  States  have  used  the  technical  guidelines,  options  for  actions,  advice  to 
travellers,  and  other  technical  documents  provided  by  the  Commission  is  currently  lacking. 
This  kind  of  assessment  should  be  promoted  in  the  future  to  have  an  evidence  based 
appreciation  of  the  impact  and  the  use  of  such  materials  at  national  level  with  a  view  to 
identifying possible measures to improve their impact. 

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The  cooperation  among  the  relevant  Commission  services  and  the  collaboration  with  the 
Commission agencies and Member States to  implement the framework provided by Decision 
1082/2013/EU has worked well during the period. There is currently no need to introduce any 
changes in this respect. 

As  regards  Article  4  of  Decision  1082/2013/EU,  the  actions  proposed  by  Member  States  to 
ensure  that  the  IHR  core  capacities  are  maintained  and  strengthened  in  the  future  include 
regular  follow-up  with  all  Member  States,  training  and  exercises,  sharing  experiences, 
guidelines and procedures, and technical support and expertise with preparedness and response 
planning. 

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