Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on Pandemic Influenza Preparedness and Response Planning in the European Community
Date: 2005-11-28
Institutions: European Commission
Subjects: action programme, disease prevention, epidemic, health policy, illness

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 28.11.2005 
COM(2005) 607 final 

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE 
EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMITTEE OF THE REGIONS 

on Pandemic Influenza Preparedness and Response Planning in the European 
Community 

EN 

   EN 

 
 
 
  
TABLE OF CONTENTS 

1. 

2. 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

3.5. 

4. 

Background and Aim of the Communication .............................................................. 4 

Pandemic Influenza Preparedness in the European Union .......................................... 5 

Main Tasks for Member States, Commission and Community Agencies ................... 7 

Planning and Coordination........................................................................................... 8 

Monitoring and assessment .......................................................................................... 8 

Prevention and containment....................................................................................... 10 

Health system response .............................................................................................. 12 

Communication .......................................................................................................... 13 

Pandemic Phases and EU Alert Levels ...................................................................... 14 

WHO PHASE 1 (Inter-pandemic period) ................................................................................ 16 

WHO PHASE 2 (Inter-pandemic period) ................................................................................ 16 

Responsibilities and actions ..................................................................................................... 16 

WHO PHASE 3 (Pandemic alert period)................................................................................. 17 

Responsibilities and actions ..................................................................................................... 17 

4.1.1.  Commission................................................................................................................ 17 

4.1.2.  ECDC ......................................................................................................................... 18 

4.1.3.  Member States............................................................................................................ 19 

WHO PHASE 4 (Pandemic alert period)................................................................................. 19 

4.1.4.  Commission................................................................................................................ 19 

4.1.5.  ECDC ......................................................................................................................... 20 

4.1.6.  Member States............................................................................................................ 21 

WHO PHASE 5 (Pandemic alert period)................................................................................. 21 

Responsibilities and actions ..................................................................................................... 22 

4.1.7.  Commission................................................................................................................ 22 

4.1.8.  ECDC ......................................................................................................................... 23 

4.1.9.  Member States............................................................................................................ 23 

WHO PHASE 6 (Pandemic period) – EU Alert levels –1 to 4 ................................................ 24 

EU Alert level 1........................................................................................................................ 24 

EU Alert level 2........................................................................................................................ 24 

EN 

2 

   EN 

 
EU Alert level 3........................................................................................................................ 24 

EU Alert level 4........................................................................................................................ 24 

Responsibilities and actions ..................................................................................................... 24 

4.1.10.  Commission................................................................................................................ 25 

4.1.11.  ECDC ......................................................................................................................... 25 

4.1.12.  Member States............................................................................................................ 26 

4.2. 

Post-pandemic period: recovery and return to inter-pandemic period....................... 27 

5. 

Conclusions ................................................................................................................ 27 

ANNEX 1: New WHO Phases................................................................................................. 29 

ANNEX 2: Projects related to influenza funded under the public health programme............. 30 

ANNEX 3: EU supported research related to human pandemic influenza .............................. 31 

EN 

3 

   EN 

 
1. 

BACKGROUND AND AIM OF THE COMMUNICATION 

Many  European  citizens  are  affected  by  influenza  every  winter.  In  a  normal  seasonal 
influenza  epidemic,  between  5  and  10%  of  the  population  becomes  ill.  Past  influenza 
pandemics  have  affected  the  population  with  much  severe  magnitude  than  seasonal 
epidemics,  with  attack  rates  ranging  from  10  to  50%.  There  were  three  pandemics  in  the 
twentieth century: the Spanish flu of 1918-1920 (the largest; it caused more than 20 million 
deaths, perhaps even 50 million deaths worldwide), the Asian flu of 1957-1958, and the Hong 
Kong  flu  of  1968-1969.  The  progression  of  a  highly  pathogenic  avian  influenza  (HPAI) 
epidemic  from  China  and  Southeast  Asia  has  given  rise  to  concerns  that  an  influenza  virus 
might arise, fully adapted to human-to-human transmission and capable of causing millions of 
deaths and huge economic damage. 

Whilst  it  is  impossible  to  predict  next  pandemic’s  onset,  health,  social  and  other  essential 
services are likely to be under severe pressure from its outset. An influenza pandemic would 
result  in  a  high  level  of  public,  political  and  media  concern  and  will  cause,  throughout  and 
beyond the pandemic period, widespread social and economic disruption. Anxiety, movement 
restrictions, constraints on public gatherings, distribution difficulties, great number of excess 
deaths are all likely to add to pressures and disruption to the society. 

Effects  of  the  pandemic  on  societies  are  inevitable,  but  careful  preparedness  and  response 
planning can contribute to mitigating the extent and impact. Comprehensive national and local 
communications  strategies  that  are  complementary  and  supported  by  mechanisms  to  ensure 
timely, accurate and clear advice and information must be fundamental to all plans. Planning 
for a pandemic is a complex matter as there is little knowledge of the likely impact: data are 
uncertain  and  lack  common  features.  Based  on  previous  pandemics,  expert  advice  and 
theoretical  modelling,  most  national  preparedness  plans  are  based  on  planning  assumptions 
which include: 

Attack rate: this is the proportion of the population that develop clinical influenza during a 
pandemic. In the absence of any intervention, planners assume that over a period of 9 to 15 
weeks some 30% of the population will become ill. Attack rates, and severity of illness, are 
likely  to  vary  between  age  groups,  but  as  neither  children  nor  adults  are  likely  to  have 
immunity to the new virus, for planning purposes a uniform attack rate, more serious illness 
and  higher  mortality  rates  than  normal  ‘seasonal’  influenza  must  be  assumed  across  all  age 
groups. 

Case fatality rate: the proportion of ill people that would die due to influenza. Most national 
plans  base  their  assumptions  on  a  percentage  of  0.37%  overall  case  fatality  rate  over  a 
pandemic period. 

Clinical  consultations:  50%  of  the  ill  people  are  expected  to  seek  general  practitioner  or 
outpatient medical care. 

Hospital  admissions:  for  acute  respiratory  and  related  conditions,  influenza-like  cases  are 
likely to represent 1% of clinical cases. 

Rate of Intensive Care: it is expected that 15% of the patients hospitalised for influenza-like 
illness will need intensive care, and 50% of these may need mechanical ventilators. 

EN 

4 

   EN 

 
Work  absenteeism:  for  planning  purposes  it  should  be  assumed  that  a  cumulative  total  of 
30%  of  the  work  force  will  take  five  to  eight  working  days  off  over  a  three-month  period. 
Influenza  spread  will  be  accelerated  in  schools  and  other  closed  communities  leading  to  a 
potential  need  to  close  schools.  This,  combined  with  travel  disruption  and  the  need  for 
workers to provide care for family members and others, will exacerbate absenteeism. 

It is primarily the responsibility of each Member State to take the measures best adapted to 
fight human influenza pandemics. However, no country can alone face the consequences of a 
pandemic. International cooperation is an absolute necessity if its impact is to be reduced. In 
the EU, where there are no internal borders, additional coordination measures are necessary. 
Hence the need for EU-level action.  

All Member States have drawn up and strengthened their pandemic influenza preparedness in 
recent months with assistance from the Commission and the WHO, and further work is being 
carried  out,  backed  by  conclusions  of  the  Council1  and  of  the  Health  Ministers  at  their 
informal meeting on 20 October 2005. the Commission takes on an important role in assisting 
Member  States  and  coordinating  measures  at  EU  level,  using  in  particular  the  Community 
Network for the epidemiological surveillance and control of communicable diseases2 and its 
Early Warning and Response System (EWRS)3 and their mandatory arrangements for official 
notification  of  disease  cases  and  events  and  information,  consultation  and  coordination  of 
measures  taken  or  planned.  The  Commission  has  worked  for  a  number  of  years  to  help 
improve  the  pandemic  preparedness  of  the  European  Union  and  its  Member  States,  as 
described in the Commission working paper4 on the subject published in March 2004. Since 
then, the WHO has reviewed its description of the various pandemic phases (See ANNEX 1) 
and  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC)  set  up  by  Regulation 
(EC)  No  851/2004  of  the  European  Parliament  and  of  the  Council5  became  operational  in 
Stockholm  in  May  2005,  providing  advice  and  expertise  and  assisting  the  Commission  by 
operating  the  EWRS.  In  view  of  these  developments,  it  became  necessary  to  revise  the  EU 
pandemic  influenza  preparedness  and  response  plan.  The  revised  plan  is  set  out  in  this 
communication. 

2. 

PANDEMIC INFLUENZA PREPAREDNESS IN THE EUROPEAN UNION 

Recommendations  on  actions  before  and  during  pandemics  have  been  issued  by  the  WHO6 
and serve as the basis for planning by countries all over the world. Planning at the EU level is 
based on the same recommendations, however, specific provision has to be made for certain 
circumstances and conditions particular to the EU. If pandemic influenza circumstances were 
identified  first  outside  the  EU,  the  recognition  of  the  pandemic  (Phase  6  of  the  WHO 
recommendations) will almost certainly be first issued by the WHO. However, recognition of 
a state of a public health emergency linked to the emergence of a pandemic strain may come 
earlier.  Once  the  EU  becomes  affected,  different  Member  States  may  move  through  the 
phases at different times and rates. Therefore, for EU purposes, the epidemic activity within 
the  EU  and  in  Member  States  has  special  significance  and  needs  additional  detail  in  the 

1 
2 
3 
4 
5 
6 

SAN 104, 9882/04, 2.6.2004 
OJ L 268/1-7, 3.10.1998 
OJ L 21/32-35, 26.1.2000 
http://europa.eu.int/eur-lex/en/com/wdc/2004/com2004_0201en01.pdf 
OJ L 142/1-11, 30.4.2004 
http://www.who.int/csr/resources/publications/influenza/WHO_CDS_CSR_GIP_2005_5.pdf 

EN 

5 

   EN 

 
                                                 
framework of the WHO classification. A series of measures to be considered at EU level are 
described  in  this  communication  for  each  phase  and  would  apply  in  the  specific 
epidemiological context. 

In  March  2005,  the  Commission  and  the  WHO  Regional  Office  for  Europe  organised  a 
workshop  to  discuss  pandemic  plans  and  identify  gaps  and  improvements  needed.  Political 
commitment,  increased  resources  for  pandemic  preparedness,  more  research  and  the 
resolution of complex legal and ethical issues were identified as key issues and strong interest 
was expressed in developing common solutions and cross-border co-operation7. 

In  July  2005,  the  Commission  wrote  to  all  Health  Ministers,  asking  them  to  provide 
information  about  the  state  of  preparedness  of  their  country,  in  particular  availability  of 
national  plans,  anti-virals  and  vaccination  policy.  All  responses  and  national  plans  were 
assessed by the Commission, in consultation with the Health Security Committee (ref.1) and 
the ECDC. They were further discussed between Health Ministers and the Commission at an 
informal meeting organised by the UK Presidency on 20 October and considered at a second 
EC/WHO joint workshop on 24 - 26 October 2005. Moreover, joint assessment visits with the 
WHO  and  ECDC  have  started  to  take  place  in  EU  Member  States  and  other  European 
Countries. The preliminary findings show that the state of preparedness is generally limited to 
the health sector. Some plans need to be made more operational – in particular contingency 
plans for health care facilities and civil services, as well as training for the workforce. 

Most  Member  States  have  addressed  in  their  plans  priority  issues  such  as  command  chain 
structure, communication strategy and laboratory capacity. About half of the Member States 
have  so  far  covered  measures  on  international  travel,  contact  tracing  and  quarantine  and 
limitation  of  movements.  Some  Member  States  have  assessed  the  need  for  measures 
concerning national citizens abroad. 

The  Commission  has  conducted  a  simulation  exercise  on  pandemic  influenza  (“Common 
Ground”)  to  test  communications  and  preparedness  plans  and  coordination  between  the 
Member States, Commission and Community agencies, such as the ECDC and the European 
Medicines  Evaluation  Agency  (EMEA),  as  well  as  with  the  WHO.  .The  results  and  lessons 
from this exercise will be important in the efforts to improve plans and their interoperability. 

To  ensure  better  cooperation  between  the  public  health  and  the  animal  health  sectors  the 
Commission brought together the Chief Medical Officers (CMO) and the Chief Veterinarian 
Officers  (CVO)  of  the  EU  on  22  September  2005.  This  meeting  marked  the  start  of  an 
ongoing process to ensure better coordination between  veterinary and  health authorities and 
services in addressing key aspects of influenza control. 

Such is the nature of the threat that it is obvious that providing protection for Member States 
implies  increasing  protective  and  preventative  measures  globally.The  Commission  together 
with the Member States is also providing support to international collaborations, in particular 
the work of the UN Agencies such as the WHO, FAO, OIE, and the work of the World Bank, 
to assist third countries, especially countries which are currently affected by avian influenza, 
in  order  to  improve  their  surveillance  and  disease  control  capacities,  particularly  the  least 
developed and  the most vulnerable countries, specifically  referring  to Africa and Asia. This 
will include assistance to provide access to essential medical products. 

7 

http://europa.eu.int/comm/health/ph_threats/com/Influenza/influenza_key04_en.pdf 

EN 

6 

   EN 

 
                                                 
The  EU  proposes  to  co-sponsor  a  pledging  conference  with  the  World  Bank  and  China  to 
secure support for a form of Trust Fund to combat Avian Influenza worldwide 

It  is  also  important  that  the  Commission  and  Member  States  insist  that  epidemiological 
reporting be prompt, accurate and totally transparent across the world.There is also a need for 
the  Community  to  facilitate  increasing  involvement  of  European  Neighbourhood  Policy 
(ENP) partners in work in this area. Currently Action Plans with six countries refer to such 
work (Ukraine, Moldova, Israel, Jordan, Morocco, Tunisia). 

Concerning the most potent interventions to face up to a pandemic, the Commission and the 
Member  States  are  working  together  to  ensure  availability  of  vaccines  and  anti-virals.  The 
Commission, with help from the EMEA and the Member States, has published a document8 
on  a  private-public  partnership  to  encourage  the  production  of  pandemic  vaccines  in  the 
shortest  possible  time.  Key  issues  identified  are  coverage  of  as  many  virus  sub-types  as 
possible,  clinical  trials,  increase  in  capacity  by  increasing  inter-pandemic  vaccination  and 
surveillance  of  immunisation  status  and  adverse  effects.  As  regards  anti-virals,  the 
Commission  has  undertaken  efforts  to  stimulate  strategies  for  their  acquisition  and  use  and 
this has led to benefits for Member States in terms of insights and crucial information about 
conditions  of  supply  and  limitations,  as  well  as  interest  in  the  pharmaceutical  industry  for 
involvement of more companies in this area. 

Member States are also assessing, with the assistance of the Commission and the ECDC, the 
need and specifications for masks and other devices such as respirators. 

3. 

MAIN TASKS FOR MEMBER STATES, COMMISSION AND COMMUNITY AGENCIES 

A  crucial  element  of  responses  to  a  pandemic  at  any  level  is  to  ensure  that  they  are  multi-
sectoral  and  encompass  services  outside  the  health  sector.  Member  States  and  the 
Commission  must  ,  therefore,  have  in  place  and  update  strategies  for  planning  and 
coordination that will facilitate multi-sectoral collaboration.  

The development of plans for pandemic influenza involves the principles and components of a 
planning process presented in the Commission Communication on strengthening coordination 
on generic preparedness planning for public health emergencies at EU level9. Application of 
this planning process to pandemic influenza has identified the following key topics on which 
to base the EU pandemic influenza plan: 

–  planning and coordination 

–  monitoring and assessment 

–  prevention and containment 

–  health system response 

–  communication 

These topics are dealt with in turn below. 

8 
9 

http://europa.eu.int/comm/health/ph_threats/com/Influenza/influenza_key03_en.pdf 
COM (2005) 605 final 

EN 

7 

   EN 

 
                                                 
3.1. 

Planning and Coordination 

The tasks required in each phase and at each alert level should be directed towards identifying 
and addressing the current impact and subsequent threat potential of the influenza outbreak in 
order to limit its consequences. Transition between stages of alert and action, , however, need 
to be rapid, depending on the evolution of events, and certain phases or levels may have to be 
leapfrogged. Plans, therefore, need to be flexible to allow for this contingency. 

EU added value can be achieved by improving coordination  and  communication among  the 
Commission and the Member States with assistance from the ECDC, other European agencies 
such  as  the  EMEA  and  the  European  Food  Safety  Agency  (EFSA),  and  with  the  WHO.  A 
three-tiered structure is foreseen: 

First  the  Public  Health  Preparedness  and  Response  Planning  Group  (PRPG)  of  the  Health 
Security Committee as set out in the working paper of the Commission of March 2004, has to 
undertake a number of tasks such as exchanging information, communicating and reviewing 
existing  national  preparedness  and  response  plans  and  providing  advice  on  gaps  and  co-
ordination  needs  between  national  plans,  sharing  expertise  and  good  practice  with  other 
groups working on preparedness plans, and setting up groups to advise on particular aspects 
of contingency planning. 

Secondly,  all  notification,  exchange  of  information  between  public  health  authorities  and 
consultation and coordination on measures, planned or taken by Member States must be done 
through  the  Early  Warning  and  Response  System  of  the  Community,  as  set  out  in  Decision 
2119/98/EC10  establishing  a  Community  Network  for  the  epidemiological  surveillance  and 
control  of  communicable  diseases  and  Decision  2000/57/EC11  on  the  Early  Warning  and 
Response System. 

Thirdly,  deployment  of  Outbreak  Assistance  Teams  (OATs)  will  be  part  of  the  response 
mechanism. In collaboration with the Member States, the Commission has drawn up a a core 
list of experts that could be dispatched and the ECDC is now taking this work forward.. The 
teams  would  work  with  an  agreed  mandate,  organisation,  structure,  and  detachment 
procedures. The full range of tasks of the teams may vary according to the terms of reference 
to  be  defined  by  the  ECDC,  but  would  include  the  participation  in  outbreak  investigation 
inside and outside the Community ensuring coherence and synergies with the EU’s external 
response in co-operation with the WHO and the provision of assistance in risk assessment and 
co-ordination  of  activities  on  site,  in  particular  where  they  cross  over  Member  State 
boundaries.. 

3.2.  Monitoring and assessment 

The most important task of the surveillance and diagnostic systems of the Member States is to 
provide  early  detection  and  characterisation  of  pandemic  strains  from  clinical  or  other 
specimens and a reliable risk assessment as to its potential to cause widespread outbreaks in 
humans. Key elements are good coverage of virological diagnosis for suspicious cases, with 
rapid and effective characterisation of virus strains isolated from patients, and assessment of 
the  epidemiological  impact,  in  particular  the  burden  of  disease.  Effective  surveillance  of 
influenza is a major part of ensuring a timely alert on an upcoming pandemic. 

10 
11 

OJ L 268/1-7, 3.10.1998  
OJ L 21/32-35, 26.1.2000 

EN 

8 

   EN 

 
                                                 
The  ECDC  plays  a  co-ordinating  role  in  the  surveillance  effort.  The  Member  States  are 
obliged  to  report  influenza  outbreaks  to  the  Community  network  of  communicable  diseases 
set up by Decision 2119/98/EC. Being part of this network, the Early Warning and Response 
System (EWRS) is the central plank for the Community response. The system is interlinking 
the Member States’ public health authorities. Under EWRS, formal and prompt notification of 
cases must take place with immediate transmission of information by the Commission to all 
the  Member  States,  as  well  as  (prior,  where  possible)  consultation  and  coordination  of 
counter-measures by the Member States. 

Surveillance of influenza infections in animals, in particular in bird populations, is important 
and is a requirement under EC law, as animals may harbour a great variety of influenza virus 
strains. Based on the experience gained from a EU-wide survey on domestic poultry and wild 
birds , a targeted surveillance programme will be further improved. 

Timely communication of surveillance findings in humans and animals is essential in order to 
have  the  maximum  time  span  to  prepare  for  vaccine  production  and  other  public  health 
counter-measures. Adequate laboratory capacity and enhanced diagnostic capabilities need to 
be  in  place  to  ensure  effective  surveillance  and  prompt  identification  of  strains  of  influenza 
virus.  Cooperation  among  laboratories  in  this  respect  is  organised  through  the  European 
Influenza Surveillance Scheme (EISS), a project aimed at monitoring influenza activity in all 
EU  Member  States  through  the  networking  of  clinicians  and  laboratories,  and  assisting  the 
Commission  in  influenza  pandemic  preparedness  planning.  EISS  is  co-funded  by  the 
Community in the framework of the Public Health Programme 2003-2008. However, national 
reference laboratories should be designated by all Member State competent authorities, and be 
recognised,  where  appropriate,  by  the  WHO  Global  Influenza  Programme  as  National 
Influenza  Centres.  The  EISS  laboratory  network  is  currently  taking  the  function  of  a 
“Community  Reference  Laboratory  for  Human  Influenza”  structure  which  is  foreseen  to  be 
set up with support through the Programme of Community action in the field of Health and 
Consumer protection 2007-201312 that the Commission proposed on 6 April 2005. 

Sentinel  clinical  surveillance  should  start  in  Member  States  with  good  systems  of  case 
recognition  by  clinicians  linked  to  virological  surveillance  and  should  include  age-specific 
morbidity  and  where  possible  also  mortality  and  rates  of  hospitalisation.  Clinical 
manifestations  may  change,  especially  during  the  later  pandemic  waves  when  new  patterns 
may emerge. 

The impact of vaccination programmes and other health measures should be assessed as the 
seasonal  patterns  of  circulating  influenza  strains  and  consequently  the  composition  of 
vaccines  vary  from  year  to  year.  Greater  emphasis  should  be  placed  on  systematic 
surveillance of the impact of vaccination programmes on morbidity and mortality and on good 
information on the immunization status in the EU. Since pandemic vaccines will be produced 
only  after  some  months  following  isolation  of  the  pandemic  strain  but  will  be  administered 
without the conventional trials, there will be a need for monitoring of its effectiveness, safety 
and side effects. 

The ECDC assumes the tasks related to the epidemiological surveillance under the plan, takes 
part in the organisation and conduct of influenza outbreak assistance, and provides advice on 

12 

http://www.cc.cec/home/dgserv/sg/sgvista/i/sgv2/repo/repo.cfm?institution= 
COMM&doc_to_browse=COM/2005/0115&refresh_session=YES 

EN 

9 

   EN 

 
                                                 
options and guidelines for appropriate responses in the various phases and levels contained in 
the plan. 

The  Commission  is  presently  funding  projects  under  the  Public  Health  Action  Programme 
(2003-2008) to strengthen surveillance and preparedness at EU level (see ANNEX 2).  

3.3. 

Prevention and containment 

A  key  countermeasure  for  preventing  influenza  is  vaccination.  A  pandemic  vaccine  will  be 
produced  after  the  pandemic strain  is isolated, but this may take some 6-8 months before it 
becomes  available.  Moreover,  capacity  for  producing  vaccines  is  inadequate.  Each  Member 
State should prepare plans for vaccinating priority groups. The Commission, with assistance 
from the ECDC and WHO already facilitates co-ordination of plans to ensure inter-operability 
and to avoid confusion and public concern over differences in the levels of health protection 
afforded in various parts of the EU. 

At  the  onset  of  a  pandemic,  anti-virals  constitute  the  first  pillar  of  medical  prevention  and 
intervention  until  vaccines  become  available.  Member  States  should  consider  how  to  use 
limited stocks due to limited current availability, and to prioritize those who should receive 
the drugs during the first wave, particularly focussing on those who are ill with the pandemic 
strain and, therefore, most likely benefit from early treatment. The Commission facilitates the 
exchange of information and sharing of good practice in this area. For both vaccines and anti-
virals,  issues  of  equitable  distribution  and  “mutualisation”  of  stocks  to  fight  the  disease  at 
source  have  been  put  forward,  in  view  of  the  lack  of  manufacturing  capacity  in  many 
countries and the perceived imbalance between rich and powerful countries that collect strains 
through  collaboration  programmes  with  poor  and  affected  ones  but  benefit  from  (their) 
manufacturers’ production only themselves. 

Information  concerning  the  annual  use  of  vaccines  in  risk  groups  and  the  general  public 
should  be  collected  to  provide  a  basis  for  estimates  of  eventual  needs  during  a  pandemic. 
Estimates of probable needs during a pandemic would help the annual vaccine supply process. 
As part of the plan the following could be pursued: 

•  Provision  of  estimates  of  the  need  for  vaccines,  anti-virals  and  antibiotics  from  Member 

States according to the likely scenarios for their use, 

•  Determination of priority groups for vaccination, when vaccine is in short supply; 

•  Establishment  of  options  for  public  health  measures  to  minimise  morbidity  and  social 

disruption when there is rapid accumulation of cases of influenza; 

•  Collection  of  information  from  manufacturers  about  production  capacities  and  plans  for 

vaccines, antivirals and antibiotics. 

The Commission is supporting projects in this area. Most importantly, the Commission agreed 
with  the  Member  States  a  policy  document  on  public-private  partnership  (PPP)13  between 
public  bodies  and  the  vaccine  industry  to  deliver  influenza  vaccine  to  the  European  Union 
population in the shortest possible time in the event of influenza pandemic.  

13 

http://europa.eu.int/comm/health/ph_threats/com/Influenza/influenza_key03_en.pdf 

EN 

10 

   EN 

 
                                                 
The work undertaken under the Council’s mandate in this area has produced already results in 
providing useful insights for the Member States to negotiate with industry and has prompted 
the  industry  to  start  producing  mock-up  files  and  reviewing  costs  and  prices,  as  well  as 
stimulating more companies to be involved in the production of vaccines. 

Industry’s  stated  contribution  to  the  PPP  is  the  development  of  the  prototype  influenza 
vaccines in accordance with the guidance produced by EMEA14 to prepare mock-up dossiers. 
Four  companies  have  announced  their  intention  to  prepare  such  a  dossier  in  the  coming 
months.  Industry  will  ensure  the  production  of  the  pandemic  vaccines,  using  all  facilities 
available at the time of the pandemic.  

The public sector would support industry starting with the development of a library of seed 
stocks  for  manufacturing  of  influenza  vaccine.  It  could  furthermore  provide  support  for 
clinical  trials  for  the  mock-up  vaccine  and  development  of  post  marketing  surveillance 
systems.  It  would  assist  the  industry  in  the  clinical  trials  and  data  gathering  of  alternative 
vaccine formulations, including varying doses of antigen and the use of adjuvants. The public 
sector would further undertake serological and animal challenge studies to provide scientific 
evidence  for  the  likely  protective  efficacy  of  candidate  vaccines  against  a  particular 
circulating  pandemic  strain.  The  time  saved  in  having  a  vaccine  available  for  public  use  by 
these activities is potentially 2 to 3 months and possibly more. 

Current vaccine production capacity is not deemed to be sufficient to meet the demands of the 
Community  in  the  event  of  a  pandemic.  Manufacturers’  reserve  capacity  is  not  likely  to  be 
enough to support a sudden increase in demand. Part of the public contribution would be to 
increase the use of inter-pandemic influenza vaccine, thus contributing to increasing capacity, 
by ensuring that uptake is raised to the levels recommended by the World Health Assembly 
resolution  56.1915  which  foresees  coverage  of  75%  of  the  risk  groups  identified  by  the 
Member  States.  It  is  noted  that  inter-pandemic  vaccine  uptake  in  2005  has  been  greatly 
increased and stocks have run out in many EU Member States. 

Work  on  the  implementation  of  the  public-private  partnership  is  on-going  to  reduce 
significantly the ‘time to market’. To reach this objective and to accelerate the evaluation of 
new  specific  pandemic  vaccines,  the  Commission has agreed with the EMEA to waive fees 
for the registration of dossiers Member States’ efforts to acquire pandemic vaccines might be 
supported  by  the  Community  following  the  tabling  by  the  Commission  on  6  April  2005  a 
proposal  for  a  regulation  of  the  European  Parliament  and  of  the  Council  establishing  the 
European  Union  Solidarity  Fund16  to  develop  the  solidarity  strand  of  the  Commission’s 
integrated  approach,  in  order  to  ensure  response  to  major  disasters  or  public  health 
emergencies, independent of their nature and origin. The Commission calls upon Council and 
European  Parliament  to  conclude  the  work  on  the  proposed  EUSF  regulation  as  soon  as 
possible with a view to its earliest possible entry into force. 

The geographical scope is limited to Member States and countries negotiating their accession 
to the EU. The thematic scope includes public health threats and acts of terrorism. The fund 
remains  limited  to  "major"  disasters  defined  as  events  resulting  in  total  direct  damage  in 
excess  of  EUR  1  billion  or  0.5%  Gross  Net  Income  (GNI)  of  the  affected  country 

14 
15 
16 

EMEA/CPMP/4986/03 & EMEA/CPMP/4717/03, Réf.:http://www.emea.eu.int/indem/indexh1.htm 
http://www.who.int/gb/ebwha/pdf_files/WHA56/ea56r19.pdf 
COM (2005) 108 final, 6.4.2005 http://europa.eu.int/comm/regional_policy/funds/solidar/solid_en.htm 

EN 

11 

   EN 

 
                                                 
respectively, or if the Commission in duly justified and exceptional circumstances, where the 
consequences  are particularly serious but  which cannot be assessed on the basis of physical 
damage alone, it declares a disaster situation as "major". This will be particularly important to 
help protect the EU in the case of pandemics, in particular in officially recognised influenza 
pandemics. Effective protection will require widespread and rapid use of anti-viral drugs and 
vaccines.  

The EUSF could be used to help refinance the cost of these drugs. Mobilisation of the Fund, 
as  under  the  current  procedure,  would  be  possible  only  upon  request  of  an  eligible  State. 
Following the Commission's assessment and proposal to the budget authority of an amount of 
financial  assistance  to  be  granted,  the  latter  adopts  a  corresponding  supplementary  budget. 
The Commission will then adopt a grant decision, which is followed by the conclusion of an 
implementation agreement, leading to the payment for the grant.  

With  the  proposal  for  a  regulation  establishing  the  European  Union  Solidarity  Fund  the 
Commission  suggests  strengthening  and  widening  the  possibilities  for  responding  to  public 
health emergencies. This covers the immediate medical assistance and measures to protect the 
population  against  imminent  health  threats,  including  the  cost  of  vaccines,  drugs,  medical 
products,  equipment  and  infrastructure  used  during  an  emergency.  The  use  of  this  fund, 
however, is linked to specific requirements and represents in its basic concept a refunding and 
thus  response  type  instrument,  with  standard  procedures  that  usually  take  some  time. 
Therefore,  the  Commission  had  suggested  an  advance  funding  mechanism  to  allow  for  a 
limited funding with short reaction time. 

Availability of vaccines or antivirals to populations most at risk may, in critical situations, be 
further  limited  by  measures  imposed  by  Member  State  authorities  to  provide  maximum 
protection to their own population. Measures should, therefore, be considered with a view to 
ensuring  equity  of  access.  Further  collaboration  with  the  industry,  the  Member  States  and 
others is needed. Measures should not, however, include the promotion of any behaviour in 
breach of EU competition rules. 

Non-pharmaceutical measures such as hand-washing and social distancing will play important 
roles  in  reducing  the  impact  of  pandemic  influenza.  The  ECDC,  working  with  the 
Commission and national and international bodies, will prepare evidence-based guidance on 
these topics for use by the Member States.  

Finally,  the  Commission,  through  its  Research  Framework  programs,  is  since  1998  co-
financing projects in the field of human pandemic influenza. These efforts should be carried 
on through the 7th Framework program17 (ANNEX 3). 

3.4. 

Health system response 

To  ensure  effective  and  safe  treatment  of  human  cases  of  a  novel  influenza  strain,  it  is 
important that hospitals have well established emergency plans to handle numerous cases and 
ensure continuity and resilience, clinical guidelines are ready, supplies are available and staff 
is  aware  of  admission  criteria.  It  is  Member  States  responsibility  and  competence  to  ensure 
that citizen have access to best practice and it is a Community objective that inequities in this 
area  are  smoothed  among  countries  and  regions.  Moreover,  staff  working  in  health  care 

17 

COM (2005) 119 final, 6.4.2005 

EN 

12 

   EN 

 
                                                 
should  be  aware  of  and  trained  in  infection  control  measures.  Member  States  should  ensure 
the  development  and  implementation  of  clinical  management  guidelines  for  patients  with 
suspected and confirmed pandemic strain influenza infection. Guidelines for infection control 
are important to clarify the routes of transmission and ways to interrupt transmission through 
hygienic  measures.  Infection  control  is  an  essential  part  of  patient  management,  and  helps 
prevent  further  spread  to  the  public,  and  Member  States  need  to  consider  their  neighbours’ 
quality  of  services  to  be  ready  to  respond  to  citizens  seeking  assistance  over  the  national 
borders. 

It is crucial that health services adapt to pandemic conditions so that basic care for those most 
in need is maintained. In order to ensure this, several emergency steps need to be developed to 
ensure  a  sensible  personnel  and  volunteer  corps  management  and  to  make  optimal  use  of 
facilities  and  available  pharmaceutical  products.  In  general,  activities  in  this  area  should  be 
based upon a general health emergency preparedness plan. It will be important to coordinate 
clinical  care  and  health  services  plans  with  bordering  jurisdictions  to  avoid  that  patients 
migrate across borders in expectation of better health care. 

With  its  Communication18  on  the  Community  strategic  guidelines  for  cohesion  policy  in 
support of growth and jobs (2007-2013), the Commission suggested to include the prevention 
of  health  risks  and  filling  the  gaps  in  health  infrastructure  as  strategic  parameters  for  the 
future  cohesion  policy.  For  those  Member  States  planning  to  develop  horizontal  cohesion 
policy programmes on health and those regions that intend to integrate health related priorities 
in  their  operational  programmes,  the  Commission  recommends  a  thorough  linking  between 
them and the national preparedness plans. Special attention should be paid also to possibilities 
offered  by  the  forthcoming  cohesion  policy  instruments  on  territorial  cooperation,  in 
particular the cross-border cooperation.’ 

3.5. 

Communication 

Communication to the public 

A  communications  plan  has  to  be  prepared  for  each  phase  and  level.  The  more  serious  the 
threat, the more important it will be to ensure efficient communication to the general public 
and to the media. 

The  perceived  threat  of  a  pandemic  can  give  rise  to  considerable  media  interest.  Making 
reliable information about the potential threat should be a key priority of Member States, the 
ECDC  and  the  Commission.  Giving  out  authoritative  information  at  an  early  stage  will 
prevent  the  creation  of  an  “information  void”  that  the  media  may  fill  with  speculation  and 
rumour.  To  ensure  they  are  in  a  position  to  do  this,  the  Member  State  authorities  in  liaison 
with the Commission and the ECDC, should develop a range of ready to use media briefing 
materials about influenza. A number of Member States have already done this, and have for 
example,  given  a  certain  amount  of  basic  information  about  the  disease  and  the  systems  in 
place to respond to major outbreaks. 

During  an  influenza  epidemic,  information  about  both  EU  level  and  national  actions  to 
address the threat will need to be communicated to the media, and the public, in a timely and 
consistent  manner.  The  approach  to  communication  needs  to  be  considered  early  on  in  the 

18 

COM(2005)304 final, 5.7.2005 

EN 

13 

   EN 

 
                                                 
process of addressing a potential pandemic. Member States, the ECDC and the Commission 
should further develop communication plans and endeavour to co-ordinate accurate messages 
and  statements  to  the  media  about  the  threat  and  the  planned  measures  in  order  to  avoid 
confusion and contradictory statements. 

One way of ensuring the sharing of information among Member States and openness  to the 
public and the media will be, during a pandemic, to publish regular reports on the Internet of 
the  state  of  the  pandemic  around  Europe.  This  way  of  working  proved  effective  during  the 
SARS outbreak. 

Arrangements  for  vaccination  and  distribution  of  antiviral  agents  will  vary  from  country  to 
country depending on their national plans. Communicating to health professionals and to the 
public  about  these  arrangements  will  necessarily  be  a  task  for  Member  State  authorities. 
Nonetheless, even in these circumstances there will be a need for EU-wide co-ordination. It 
will  help  reinforce  public  confidence  in  the  response  strategy  if  Member  States  and  the 
Commission  can  demonstrate  that  the  national  strategies  across  the  EU  are  consistent  and 
based on a common assessment of the relevant science. 

Communication among competent health authorities  

Fast  exchange  of  information  and  prompt  notification  during  the  first  stages  of  a  pandemic 
influenza  are  essential  in  enabling  Member  States,  the  Commission,  the  ECDC,  WHO  and 
other bodies to respond with common positions in public communications, and alert properly 
their structures, so that measures can be implemented in a timely manner.  

The Commission has undertaken action to coordinate the media services of the authorities of 
the  Member  States  in  charge  of  public  Communications  on  pandemic  influenza.  In  October 
2005 a technical guidance document on ‘Procedure for Communication to Member States, the 
Commission and the ECDC about highly pathogenic Avian Influenza events in humans’ has 
been agreed and published on the Europa website19. 

4. 

PANDEMIC PHASES AND EU ALERT LEVELS 

The  key  measures  to  be  planned  and  implemented  in  regard  to  influenza  pandemics  can  be 
grouped  under  the  phases  and  levels  presented  below.  Different  sets  of  action  have  to  be 
undertaken by the Commission and the Member States, but there are also actions that have to 
be carried out jointly. Actions are assembled for various phases and levels and would benefit 
from the assessment of the epidemiological situation carried out by ECDC and the WHO on 
the basis of scenarios and geographical spread as described below. 

The  choice  of  phases  and  levels  is  consistent  with  the  recommendations  of  WHO  and  its 
definition  of  pandemic  phases.  However,  due  to  the  specific  circumstances  of  the  European 
Union,  which  is  characterised  by  the  absence  of  internal  borders  and  the  free  circulation  of 
persons and goods, the following four levels of EU alert are to be used under WHO Phase 6 
(pandemic period), following consultation with Member States, WHO and ECDC: 

19 

http://europa.eu.int/comm/health/ph_threats/com/Influenza/influenza_key09_en.pdf 

EN 

14 

   EN 

 
                                                 
EU Alert levels in pandemic phase 6: 

One – no confirmed human cases infected with the pandemic virus in any EU Member State; 

Two  –  one  or  more  confirmed  human  cases  infected  with  the  pandemic  virus  in  any  EU 
Member State; 

Three  –  a  confirmed  outbreak  (transmission)  with  the  pandemic  virus  in  any  EU  Member 
State; 

Four – widespread transmission in EU Member States 

Within  these  alert  levels  and  especially  Alert  Level  4,  experience  with  seasonal  influenza 
transmission suggests that pandemic activity will not be uniform across the EU and this will 
be  the  described  by  Member  States  and  the  ECDC.  A  planning  assumption  is  that  the 
pandemic  does  not  emerge  in  a  Member  State  and  additional  measures  will  need  to  be 
undertaken  between  the  first  and  second  waves  of  a  pandemic  and  after  a  vaccine  becomes 
available. 

The following actions are common to each pandemic phase and therefore will be considered 
by the relevant actors each time the situation moves to a subsequent phase: 

Planning and coordination 

Member States are obliged to inform, consult and coordinate measures with the other 
Member States and the Commission using the EWRS and, where appropriate, other 
mechanisms; 

Commission organises the information, consultation and coordination of measures. 

Monitoring and assessment 

Member  States  are  obliged  to  transmit  information  on  detected  human  cases  to  the 
Network  on  communicable  diseases,  and  the  ECDC,  using  the  Early  Warning  and 
Response System; 

Commission  is  coordinating  the  exchange  of  information  with  the  assistance  of  the 
ECDC which is operating the EWRS. 

Prevention and containment 

Public health interventions 

– 

– 

Commission, with the assistance of the ECDC, to reiterate appropriate 
and inappropriate measures for affected and unaffected countries; 

Commission  to  advocate  that  appropriate  international  organizations 
and  associations  and  transportation  companies  develop  and  prepare  to 
implement  standard  measures  for  travellers  on  board  international 
conveyances, consistent with the pandemic phase; 

EN 

15 

   EN 

 
– 

From  phase  four  through  six:  Commission,  in  consultation  with  the 
to  assess  needs  for  recommending  additional 
Member  States, 
containment measures, e.g at international borders. 

Communications 

– 

– 

Commission to work with Member States, with the assistance of ECDC 
and  in  cooperation  with  the  WHO,  to  provide  accurate  messages 
relating to the pandemic phase; 

Commission  regularly  briefs  media  and  the  public  on  the  situation, 
maintains  capacity  for  meeting  expected  international  information 
demands and evaluate and updates communications response during the 
various phases in the light of lessons learned. 

WHO PHASE 1 (Inter-pandemic period) 

In this phase no new influenza virus subtypes have been detected in humans.  

An  influenza  virus  subtype  that  has  caused  human  infection  may  be  present  in  animals.  If 
present in animals, the risk of human infection or disease is considered to be low.  

The  main  public  health  goal  is  strengthen  influenza  pandemic  preparedness  at  the  global, 
regional, national and sub-national levels.  

This scenario includes no novel avian influenza virus detected in animals in Europe, and no 
human case. 

WHO PHASE 2 (Inter-pandemic period) 

No new influenza virus subtypes have been detected in humans.  

However,  a  circulating  animal  influenza  virus  subtype  poses  a  substantial  risk  of  human 
disease. 

Main  public  health  objective  is  to  minimize  the  risk  of  transmission  to  humans;  detect  and 
report such transmission rapidly if it occurs.  

This scenario includes no human case in the EU. 

Responsibilities and actions 

In phase 1 and 2 strengthening influenza pandemic preparedness at national and international 
levels is of pivotal importance in preparing the response in the event of a pandemic. To update 
the  status  of  preparedness  at  Community  level,  the  Commission  and  the  ECDC,  in 
consultation  with  the  Health  Security  Committee  and  in  cooperation  with  the  WHO,  assess 
review  and  organise  exercises  concerning  national  pandemic  plans,  with  a  special  focus  on 
their interoperability.  

EN 

16 

   EN 

 
WHO PHASE 3 (Pandemic alert period)  

Human  infection(s)  with  a  new  subtype,  but  no  human  to  human  spread,  or  at  most,  rare 
instances of spread to a close contact. 

In this phase, the main public health objective is to ensure rapid characterization of the new 
virus subtype and early detection, notification and response to additional cases. 

No human cases but risk of sporadic importation or appearance of isolated cases in Member 
States. 

Responsibilities and actions 

4.1.1.  Commission 

Planning and coordination 

– 

Coordinate  guidance  to  national  authorities  in  reviewing  and  updating 
national  contingency  plans,  based  on  evolving  scientific  information 
about the human case(s); 

– 

Review Commission internal contingency plan.  

Prevention and containment 

Public health interventions 

– 

 Request  affected  Member  States  to  inform  the  Commission  and  other 
Member  States  on  implementation  and  effectiveness  of  containment 
measures with a view to their coordination, via the EWRS system; 

Anti-virals 

– 

 Work  with  national  authorities  to  coordinate  availability  so  that  they 
could be swiftly deployed; 

Vaccines 

– 

– 

 Work  with  national  authorities  to  assess  the  possible  benefits  and 
disadvantages  of  vaccinating  persons  with  occupational  and  other 
exposures with seasonal vaccines, and to plan vaccination programmes 
if appropriate;  

Work  with  the  Member  States  and  the  industry  to  encourage  the 
availability of effective and sufficient vaccines. 

Health system response 

– 

Encourage  national  authorities  to  review  and  update  health  system 
response strategies at national and sub-national levels. 

EN 

17 

   EN 

 
Communications 

– 

– 

– 

Coordinate 
sharing  of  background 
effectiveness of recommended measures; 

information 

regarding 

the 

Update  other  partners,  stakeholders  and  the  public  on  the  global 
epidemiological situation and disease characteristics; 

Coordinate  sharing  of  information  regarding  the  effectiveness  of 
recommended measures with the assistance of the ECDC. 

4.1.2.  ECDC 

Monitoring and assessment 

– 

– 

– 

– 

– 

Monitor  the  pandemic  influenza  threat  through  gathering  information 
and collaboration with European Agencies (e.g. EFSA) and nternational 
bodies  (WHO,  OIE,  FAO)  and  communicate  regularly  about  its  risk 
monitoring activities;  

Facilitate  sharing  of  information  of  laboratory  confirmation  of  the 
human infection through the network of reference laboratories; 

Co-ordinate development of a case-definition for reporting by countries; 

Provide  report  forms  and  co-ordinate  rapid  reporting  of  human 
infections with a new influenza virus strain by appropriate means; 

Provide  appropriate  support  to  national  authorities  in  investigating 
case(s)  and  the  epidemiological  circumstances  of  infection,  and  in 
identifying risk groups;  

Health Systems Response  

– 

Provide scientific advice about non-pharmaceutical control measures in 
order to provide guidance to Member States in their Response Strategy 

Communications 

– 

– 

– 

Work  with  Member  States  to  promote  consistent  messages  on  the 
disease and the epidemiological situation; 

Coordinate 
effectiveness  of 
Commission 

sharing  of  background 

recommended  measures 

information 

regarding 

the 
in  consultation  with 

Regularly  update  other  partners,  stakeholders  and  the  public  on  the 
global epidemiological situation and disease characteristics. 

EN 

18 

   EN 

 
4.1.3.  Member States 

Monitoring and assessment 

– 

– 

– 

– 

Ensure  rapid  reporting  of  laboratory  confirmation  of  the  human 
infection through the network of reference laboratories; 

Apply EU-agreed case-definitions for reporting ; 

Ensure rapid reporting of human infections with a new influenza virus 
strain by using the EWRS and, where appropriate, other mechanisms; 

Investigate case(s) and the epidemiological circumstances of infection, 
and  identify  risk  groups  and  promptly  communicate  the  results  to  the 
Commission and the ECDC.  

Health System Response 

– 

Review,  update  and  disseminate  guidelines 
diagnostics, treatment, infection control and safe specimen handling. 

for  clinical  care, 

Communications 

– 

– 

– 

Work  with  other  Member  States  and  the  Commission  to  provide 
accurate messages; 

Share  with  the  other  Member  States  and  the  Commission  information 
regarding the effectiveness of recommended measures; 

Regularly  update  other  partners,  stakeholders  and  the  public  on  the 
global epidemiological situation and disease characteristics. 

WHO PHASE 4 (Pandemic alert period) 

Small  cluster(s)  with  limited  human-to-human  transmission  but  spread  is  highly  localized, 
suggesting that the virus is not well adapted to humans. 

Main public health goal is to contain the new virus within limited foci or delay spread to gain 
time to implement preparedness measures, including vaccine development. 

There  are  no  human  cases  in  EU  but  a  heightened  risk  of  importation  or  appearance  of 
isolated cases in Member States and increased risk of transmission from them. 

Responsibilities and actions 

4.1.4.  Commission 

Monitoring and assessment 

– 

In  consultation  with  the  ECDC,  coordinate  strategies  of  national 
authorities to enhance surveillance in risk groups; 

EN 

19 

   EN 

 
– 

In consultation with the ECDC, coordinate with national authorities the 
monitoring of measures on containment and control. 

Prevention and containment 

Public health interventions 

– 

Coordinate  implementation  of  recommended  additional  containment 
measures. 

Health system response 

– 

– 

Encourage  national  authorities  to  reassess  guidelines  for  clinical 
management  and  infection  control  in  health  care  (including  long-term 
care facilities); 

Encourage national authorities to prepare for the next phase, including a 
mobilization plan for health-care workers. 

Communications 

– 

With  the  assistance  of  the  ECDC,  promote  sharing  of  templates  for 
general health education materials. 

4.1.5.  ECDC 

Monitoring and assessment 

– 

– 

– 

– 

Monitor the risk for the EU with special emphasis on the potential for 
importation of cases from affected areas 

In  consultation  with  the  Commission,  coordinate  strategies  of  national 
authorities to enhance surveillance in risk groups; 

Facilitate reporting of human-to-human transmission of infection with a 
new influenza virus strain by national authorities using the EWRS; 

Provide appropriate support to national authorities in investigating cases 
and  contacts,  enhancing  disease  surveillance  to  identify  additional 
cases,  and  the  epidemiological  circumstances  of  infection  (e.g.  source 
of  exposure, 
the  general 
population), and in identifying risk groups; 

infection  of  contacts,  and  spread 

in 

Public health interventions 

– 

– 

Provide  scientific  advice  on  non-pharmaceutical  public  health 
interventions; 

In consultation with the Commission, request affected Member States to 
report  on  implementation  of  enhanced  surveillance  measures,  assist  in 
evaluating the effectiveness of such measures, and transmit appropriate 

EN 

20 

   EN 

 
information  to  all  Member  States  to  inform  national  and  international 
planning; 

– 

Review guidelines for biosafety in the influenza laboratory network. 

Communications 

– 

Ensure  regular  updating  of  information  regarding  the  risk  for  the 
European  Union  and  the  scientific  appraisal  of  of  recommended 
measures. 

4.1.6.  Member States 

Monitoring and assessment 

– 

Share  information  on  enhanced  surveillance  in  risk  groups  and  on  the 
effectiveness of measures on containment and control. 

Prevention and containment 

Public health interventions 

– 

Consult the other Member States and the Commission on any additional 
containment measures planned. 

Health system response 

– 

– 

Share guidelines for clinical management and infection control in health 
care (including long-term care facilities); 

Report  and  consult  on  preparations  for  the  next  phase,  especially  as 
regards nationals of  other Member States and  plans for  assisting other 
EU  nationals  in  third  countries,  including  protection  in  situ  and 
repatriation. 

Communications 

– 

Share intended messages to the public and educational material with the 
other Member States, the Commission and the ECDC 

WHO PHASE 5 (Pandemic alert period) 

Larger  cluster(s)  but  human-to-human  spread  still  localized,  suggesting  that  the  virus  is 
becoming  increasingly  better  adapted  to  humans,  but  may  not  yet  be  fully  transmissible 
(substantial pandemic risk).  

In this phase there is a need to maximize efforts to contain or delay spread, to possibly avert a 
pandemic, and to gain time to implement pandemic response measures. 

Localised large clusters in countries outside Europe with human-to-human transmission with 
no confirmation of international spread; there is a progressively rising risk of importation or 
appearance of isolated cases in EU. 

EN 

21 

   EN 

 
Responsibilities and actions 

4.1.7.  Commission 

Planning and coordination 

– 

– 

– 

Coordinate the ongoing evaluation of interventions; 

Finalize  preparations  for  imminent  pandemic,  including  internal 
organization and staff surge capacity; 

Activate Commission contingency plan;  

Prevention and containment 

Public health interventions 

– 

– 

Anti-virals 

– 

Vaccines 

– 

Collaborate  with  national  authorities  in  assisting  distribution  of 
infection-control  supplies  to  health-care  settings  providing  care  to 
human cases, especially if these supplies are from other Member States; 

Review Community measures or possibilities for proposals of measures 
in all relevant sectors of Community policy. 

Collaborate  with  national  authorities  in  targeting  antiviral  prophylaxis 
to  the  appropriate  groups  and  persons  and  assist  in  coordination  of 
mobilising other Member States’ stockpiles if that is necessary; 

Promote,  with  assistance  from  the  ECDC,  with  national  authorities 
preparation  and 
targeted  vaccine  campaigns 
involving appropriate groups and persons in the affected community, if 
pandemic vaccine is available; 

implementation  of 

Health system response 

– 

– 

Coordinate,  with  the  assistance  of  the  ECDC,  guidance  to  national 
authorities in assisting clinicians in recognition, diagnosis and reporting 
of cases; 

Coordinate,  with  the  assistance  of  the  ECDC,  guidance  to  national 
authorities to optimize use of scarce facilities (triage, modified clinical 
guidelines,  modified  hospital  infection  guidelines,  protection  of  non-
influenza health care services, alternative care, etc.); 

EN 

22 

   EN 

 
Communications 

– 

Encourage application of recommended measures for the public despite 
their possible limitations, and about interventions that may be modified 
or implemented during a pandemic. 

4.1.8.  ECDC 

Monitoring and assessment: 

– 

– 

– 

– 

– 

– 

Monitor the risk for the European Union with special emphasis on the 
potential for importation of cases from affected areas; 

Promote  intensification  of  disease  surveillance  in  countries  not  yet 
affected, to the maximum extent possible; 

Review and adjust case-definition and guidelines if needed; 

Accelerate  and  enhance  situation  monitoring  and  assessment  activities 
started in pandemic phase 4, to a maximum; 

Promote  monitoring  of  health-care  needs  and  facilities  in  countries  at 
risk; 

Promote  mathematical  modelling  to  forecast  trends  for  the  first 
pandemic  wave  (affected  regions,  risk  groups,  health-care  resource 
needs, impact, etc.). 

Communications 

– 

Update partners and stakeholders, and the public on the global situation, 
trends,  epidemiological  characteristics  and  recommended  measures  as 
well as the situation and risk within the EU. 

4.1.9.  Member States 

Monitoring and assessment 

– 

Assess the risk and inform promptly on investigations 

Prevention and containment 

Public health interventions 

– 

Coordinate  with  the  other  Member  States  and  the  Commission, 
additional containment measures. 

EN 

23 

   EN 

 
Health system response 

– 

– 

Implement guidelines for clinical management and infection control in 
health care (including long-term care facilities); 

Share  contingency  measures  for  the  next  phase,  especially  as  regards 
nationals  of  other  Member  States  and  plans  for  assisting  other  EU 
nationals in third countries, including protection in situ and repatriation. 

Communications 

Share  intended  messages  to  the  public  and  educational  material  with  the  other 
Member States, the Commission and the ECDC 

WHO PHASE 6 (Pandemic period) – EU Alert levels –1 to 4 

Pandemic: increased and sustained transmission in the general population.  

Several  outbreaks  in  at  least  one  country  outside  EU  with  sustained  human-to-human 
transmission, and spread to other countries.  

Main public health objective is to minimise the impact of the pandemic. 

The  following  scenarios  for  the  EU  may  occur  in  WHO  Phase  6  and  differ  in  the 
epidemiological pattern and geographical spread, and occur in chronological order; 

EU Alert level 1  

•  No human case in the EU. Very high risk of introduction or suspicion of sporadic 

imported cases into Europe; 

EU Alert level 2  

•  Isolation of pandemic subtype from a single human case inside the EU; 

EU Alert level 3 

•  Isolated  cluster  with  a  pandemic  subtype  in  one  EU  Member  State  or  sustained 
human-to-human transmission with multiple clusters confirmed inside the EU; 

EU Alert level 4 

•  Widespread activity in one or more Member States. 

Responsibilities and actions  

Actions  will  be  phased  by  alert  level,  and  implemented  in  consultation  with  all  concerned 
partners,  following  an  assessment  of  the  ECDC  on  the  epidemiological  situation  and 
predictions of evolution, and evaluation of effectiveness of measures taken by Member States. 
As  the  situation  evolves  along  the  alert  levels,  actions  need  to  be  coordinated  in  particular 
between consecutive waves of the pandemic and in relation to the availability of a vaccine.  

EN 

24 

   EN 

 
4.1.10.  Commission 

Planning and coordination 

– 

– 

– 

– 

Establish and activate pandemic influenza information and coordination 
centre; 

Interact  with  organisations  and  agencies  to  coordinate  interventions  at 
EU and international level and coordinate Member State positions; 

Coordinate ongoing development of guidelines; 

Coordinate evaluation of measures and assessment of their impact. 

Prevention and containment 

Public health interventions 

– 

– 

Coordinate  with  the  Member  States  the  position  on  movement  of 
persons  and  goods  and  cooperate  with  appropriate  international 
to 
organizations  and  associations  and 
implement  standard  measures  for  travellers  on  board  international 
conveyances, consistent with the alert level; 

transportation  companies 

Coordinate  with  the  Member  States  the  assessment  of  the  impact  of 
measures, with the assistance of the ECDC, in particular on the use of 
anti-virals and the effect of targeted vaccination campaigns. 

Health system response 

– 

Facilitate mutual aid arrangements between Member States according to 
the phasing of the pandemic, including mobilization of immune health-
care workers and the transfer of medical assets. 

4.1.11.  ECDC 

Monitoring and assessment 

– 

– 

– 

– 

Monitor  the  spread  of  disease,  risk  groups,  case  fatality  rate  and 
transmission rate, and coordinate adjustment of case definitions; 

the 

clinical,  microbiological 

Coordinate 
epidemiological 
characterisation  of  the  pandemic  strain  in  the  first  reported  clusters  in 
the  EU  in  order  to  determine  the  transmission  rate,  case  fatality  ratio 
(attributable mortality) and affected age groups. 

and 

Coordinate monitoring for possible changes in epidemiological, clinical 
and virological aspects of infection, including antiviral drug resistance; 

Coordinate  national  reporting  of  estimated  national  impact  and  assist 
global situation monitoring (global spread, national trends); 

EN 

25 

   EN 

 
– 

– 

Encourage  preparation  of  forecasts  for  the  next  wave  (new  affected 
regions, risk groups, health care resources, etc.); 

Review lessons learnt and make adjustments in surveillance guidelines 
and tools for countries. 

Prevention and containment  

Public health interventions 

– 

– 

Anti-virals 

– 

– 

Vaccines 

– 

Communication 

Coordinate  and  facilitate  assessment  of  interventions  and  update 
recommendations if needed; 

Respond to requests for the deployment of outbreak assistance teams; 

Update,  in  consultation  with  Member  States  and  the  Commission, 
guidance on the optimal use of available agents; 

Coordinate with Member States, the Commission and partners (notably. 
EMEA) monitoring of coverage, effectiveness, side effects and safety; 

When  the  pandemic  vaccine  becomes  available  coordinate  with 
Member  States,  the  Commission  and  partners  (notably.  EMEA) 
monitoring of coverage effectiveness, side effects and safety ; 

– 

– 

– 

Regularly  brief  international  organizations,  national  authorities,  other 
partners and stakeholders, and the public on the situation; 

Implement  and  maintain  capacity  for  meeting  expected  international 
information demands; 

Evaluate  communications  response  during  previous  phases;  review 
lessons learned; 

4.1.12.  Member States 

Health system response 

– 

– 

In consultation with other Member States and the Commission, promote 
improvement  of  guidelines  and  (updated)  model  algorithms  for  the 
triage of influenza and non-influenza cases; 

In consultation with other Member States and the Commission, promote 
development of guidelines on self-care. 

EN 

26 

   EN 

 
4.2. 

Post-pandemic period: recovery and return to inter-pandemic period 

After a pandemic wave is over, it can be expected that many people will remain affected in 
one way or another: many persons may have lost friends or relatives, will suffer from fatigue 
and  psychological  problems,  or  may  have  incurred  financial  losses  due  to  interruption  of 
business. Governments or other authorities have the natural role to ensure that concerns can 
be addressed and to support 'rebuilding the society'. 

Member States should have a plan in place to ensure the quick revitalization of the country 
after  a  pandemic.  This  should  include  recovery  plans  for  essential  services,  and  identify 
agencies  and  individuals  responsible  to  give  social  and  psychological  support  to  affected 
families and companies. A mechanism should also be in place to assess economic losses and 
to provide financial support to affected groups. 

Member States should ensure that essential services develop recovery plans for their services 
or  organisation.  National  preparedness  plans  should  also  consider  whether  recovery  after  a 
pandemic needs financial support from the government. If so, Member States should develop 
criteria for financial support and seek ways to ensure availability of funds. 

The  Commission,  through  the  proposed  Solidarity  Fund,  could  help  Member  States  in  the 
effort of recovery and mitigation of economic losses due to the pandemic. 

5. 

CONCLUSIONS 

This  Communication  outlines  the  key  elements  and  sets  of  actions  of  the  Community 
Pandemic Influenza Preparedness and Response Plan. Implementation will require more detail 
to be developed for those charged with operational tasks in the Commission, the ECDC, the 
EMEA  and  the  Member  States’  authorities.  It  will  need  periodic  revision  in  the  light  of 
international discussions and on the basis of experience, during seasonal influenza and from 
cross-countries exercises. 

Close co-operation will continue under the auspices of the Commission between human and 
animal health authorities and experts at national and European level in the area of influenza 
virus infections. In this context, a mutual exchange of experiences in contingency planning is 
of major importance, as contingency plans in animal health are already well established and 
have proven to be effective in the past. 

Preparing  and  responding  to  influenza  pandemics  presents  a  formidable  challenge  and 
requires increased efforts by the Member States and the Commission. This should be done as 
part of a more general approach to public health emergencies, in order to use scarce resources 
effectively,  benefit  from  the  widest  possible  expertise  and  keep  procedures  and  functions 
manageable  and  as  simple  as  possible;  the  Commission  has  published  a  communication  on 
generic public health emergency planning to aid these efforts.  

The  European  Centre  for  Disease  Prevention  and  Control  (ECDC)  can  provide  a  structured 
and systematic approach to the surveillance and control of influenza and other communicable 
diseases  that  might  affect  the  people  of  the  European  Union.  The  ECDC  can  mobilise  and 
significantly reinforce the synergies between the existing national centres for disease control 
and  will  no  doubt  help  the  Commission  and  the  Member  States  to  deal  effectively  with 
influenza. 

EN 

27 

   EN 

 
Inter-sectoral  action  will  be  a  key  issue  in  tackling  pandemic  influenza.  Many  actions  have 
already  been  undertaken  at  national  and  at  EU  level  to  ensure  that  measures  in  the  various 
sectors  of  policy  are  effective  and  coordinated.  But  more  needs  to  be  done  and  the 
Commission  and  the  Member  States  are  carrying  work  forward  in  this  respect.  Particularly 
important will be the tackling of the pandemic problem at its source; the external action of the 
Community, in this respect, is important in helping the competent international organisations 
and third countries to face up to a possible pandemic and reduce its spread and impact. 

EN 

28 

   EN 

 
1 

2 

3 

4 

5 

ANNEX 1: New WHO Phases20 

Pandemic phases 

Public health goals 

Interpandemic period 

No new influenza virus subtypes have been 
detected in humans. An influenza virus 
subtype that has caused human infection 
may be present in animals. If present in 
animals the risk of human infection or 
disease is considered to be low  

No new influenza virus subtypes have been 
detected in humans. However, a circulating 
animal influenza virus subtype poses a 
substantial risk of human disease. 

Strengthen influenza pandemic 
preparedness at the global, regional, 
national and subnational levels. 

Minimize the risk of transmission to 
humans; detect and report such 
transmission rapidly if it occurs. 

Pandemic alert period 

Human infection(s) with a new subtype, but 
no human to human spread, or at most rare 
instances of spread to a close contact. 

Ensure rapid characterization of the 
new virus subtype and early detection, 
notification and response to additional 
cases. 

Small cluster(s) with limited human to 
human transmission but spread is highly 
localized, suggesting that the virus is not 
well adapted to humans.  

Contain the new virus within limited 
foci or delay spread to gain time to 
implement preparedness measures, 
including vaccine development. 

Large cluster(s) but human-to-human 
spread still localized, suggesting that the 
new virus is becoming increasingly better 
adapted to humans, but may not yet be fully 
transmissible (substantial pandemic risk). 

Maximize efforts to contain or delay 
spread, to possibly avert a pandemic, 
and to gain time to implement 
pandemic response measures. 

Pandemic period 

6 

Pandemic: increased and sustained 
transmission in general population 

Minimize the impact of the pandemic. 

Post-pandemic period 

Post-pandemic period: return to inter-pandemic 
period 

Return to inter-pandemic period  

20 

EN 

WHO 
preparedness 
http://www.who.int/csr/resources/publications/influenza/WHO_CDS_CSR_GIP_2005_5.pdf 

influenza 

global 

WHO/CDS/CSR/GIP/2005.5 

plan 

– 

29 

   EN 

 
 
 
 
 
 
                                                 
ANNEX 2: Projects related to influenza funded under the public health programme 

The  European  Commission,  DG  SANCO,  is  presently  funding  projects  under  the  Public 
Health  Action  Programme  (2003-2008),  which  are  directly  or  indirectly  related to influenza 
preparedness and response, as follows: 

•  EISS - The European Influenza Surveillance Scheme. 

•  MODELREL  -  EU  co-ordination  and  dissemination  of  strategic  modelling  capabilities 

concerning the deliberate release of biological agents. 

•  EUNID - European Network of Infectious Diseases physicians. 

•  EPIET - European Programme for Intervention Epidemiology Training. 

•  Epi-North  –  A  framework  for  communicable  disease  surveillance,  communication  and 

training in Northern Europe. 

•  INSIGHT - International network of national public health Institutes sharing information, 

expertise and capabilities in order to grapple with major health threats. 

•  VENICE - Vaccine European new integrated collaboration effort. 

•  EPIVAC - Europe-wide pandemic influenza vaccine coverage: good epidemic vaccination 

practice by establishing integrated national stakeholders networks. 

•  ETIDE - European Training for Infectious Disease Emergencies. 

•  Epi-South  -  Network  for  Communicable  Disease  Control  in  Southern  Europe  and 

Mediterranean Countries. 

•  FLUSECURE  -  Combating  FLU  in  a  combined  action  between  industry  and  the  public 

sector in order to SECURE adequate and fast interventions in Europe. 

•  VAC-SAT - Vaccine Safety - Attitudes, Training and Communication. 

EN 

30 

   EN 

 
ANNEX 3: EU supported research related to human pandemic influenza 

5th Framework Programme (1998-2002) 

•  FLUPAN - Preparing for an influenza pandemic 

•  NOVAFLU  -  Novel  vaccination  strategies  and  vaccine  formulations  for  epidemic  and 

pandemic influenza control 

6th Framework Programme (2002-2006) 

•  VIRGIL - European vigilance network for the management of antiviral drug resistance”  

•  SARS/FLU VACCINE  

•  FLUVACC - Live attenuated replication-defective influenza vaccine  

7th Framework Programme (2007-2013) 

On  21  September  2005  the  European  Commission  proposed  a  Council  decision  concerning 
the  Specific  Programmes  implementing  the  Seventh  Framework  Programme  (2007-
2013)  of 
technological  development  and 
demonstration  activities  including  a  proposal  of  a  specific  programme  that  has  as  heading 
‘Cooperation’ and includes a particular section on health, which is consequently applicable to 
the field of flu. 

the  European  Community  for  research, 

The  focus  will  be  on  confronting  emerging  pathogens  with  pandemic  potential  including 
zoonoses (e.g. SARS and highly pathogenic influenza). Where appropriate, provisions will be 
made  for  rapidly  initiating  collaborative  research  aimed  at  expediting  development  of  new 
diagnostics, drugs and vaccines for efficient prevention, treatment, and control of infectious 
disease emergencies. 

EN 

31 

   EN