Commission working document on Community Influenza Pandemic Preparedness and Response Planning
Date: 2004-03-26
Institutions: European Commission
Subjects: action programme, disease prevention, epidemic, health policy, illness

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.03.2004 
COM(2004)201 final 

COMMISSION WORKING DOCUMENT 

on Community Influenza Pandemic Preparedness and Response Planning 

EN 

   EN 

 
 
 
  
TABLE OF CONTENTS 

1. 

2. 

3. 

4. 

Introduction .................................................................................................................. 4 

Principles, objectives and components of the preparedness plan ................................ 5 

Phases and Levels ........................................................................................................ 7 

The Commission and the Member States: Main Tasks and Role ................................ 9 

4.1. 

Management and co-ordination.................................................................................... 9 

4.1.1.  Main objectives ............................................................................................................ 9 

4.1.2.  Role of the Commission and the Member States ......................................................... 9 

4.2. 

Surveillance................................................................................................................ 10 

4.2.1.  Objectives................................................................................................................... 10 

4.2.2.  Role of the Commission and the Member States ....................................................... 11 

4.3. 

Prevention, Mitigation and Response ........................................................................ 13 

4.3.1.  Objectives................................................................................................................... 13 

4.3.2.  Role of the Commission and the Member States ....................................................... 14 

4.4. 

4.5. 

4.6. 

5. 

6. 

Communication .......................................................................................................... 16 

Civil Protection .......................................................................................................... 17 

Research ..................................................................................................................... 18 

Preparedness and Response to Influenza Pandemics : Main Actions ........................ 18 

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

2 

 
 
  
 
EXECUTIVE SUMMARY 

This working paper addresses key issues of national and EU relevance of influenza pandemic 
preparedness  and  response  planning.  It  explains  the  stages  of  an  influenza  pandemic  on  the 
basis  of  the  definitions  of  the  World  Health  Organisation  (WHO)  and  sets  out  the  main 
objectives of action. Moreover, it outlines the role of the Commission and the Member States 
in  pandemic  preparedness  planning  and  defines  key  actions  at  pre-determined  phases  and 
levels  in  the  main  areas  of  management  and  co-ordination,  surveillance,  prevention, 
mitigation and response, communication, civil protection and research. Particular reference is 
made  to  animal  health  legislation  and  actions  that  aim  to  prevent  and  control  influenza  in 
animals,  in  particular  avian  influenza,  which  can  have  a  major  role  in  the  emergence  and 
impact potential of human influenza. 

The  paper  has  been  prepared  following  extensive  consultations  on  pandemic  influenza  with 
the members of the Communicable Disease Surveillance and Response Network Committee 
hereinafter  referred  to  as  “Network  Committee”,  established  under  Decision  2119/98/EC  of 
the  European  Parliament  and  Council1  setting  up  a  network  for  the  epidemiological 
surveillance and control of communicable diseases in the Community, and an ad hoc group on 
influenza set up to advise the Commission services. The WHO and the European Medicines 
Evaluation  Agency  (EMEA)  also  took  part  in  these  consultations.  The  working  paper  was 
reviewed  at  a  meeting  in  October  2003  of  the  Public  Health  Preparedness  and  Response 
Planning  Group  (PRPG),  which  was  set  up  to  advise  the  Commission  on  all  matters 
concerning public health emergencies. 

The  paper  should  serve  as  a  launchpad  for  a  debate  on  co-ordinating  preparedness  against 
influenza  and  on  recommendations  that  can  be  made  in  this  respect.  This  will  be  done  in 
parallel with the development of a general plan for public health emergencies that the Health 
Ministers  requested  following  the  SARS  outbreak,  and  will  provide  the  basis  for  a  specific 
component  of  this  general  plan  in  order  to  fine-tune  measures  in  respect  of  an  influenza 
pandemic. 

The proposed plan sets out a considerable agenda for action that will have to meet with the 
agreement  of  and  receive  the  support  of  the  Member  States.  Certain  actions,  such  as  the 
establishment of the PRPG, have already been implemented. Most, however, will have to be 
undertaken  once  there  is  acknowledgement  of  the  need  and  usefulness  of  the  plan  for  the 
health  authorities  of  the  Member  States.  The  plan  would  then  have  to  be  put  in  place 
gradually. A significant number of the actions under the preparedness plan would have to be 
implemented at the time of an actual influenza outbreak that risks developing into a pandemic. 
The proposed European Centre for Disease Prevention and Control (ECDC), once established, 
will play a key role in this as well as in providing further advice on influenza outbreaks. 

Matters covered by  this paper will be regularly reviewed and reports to the Council will be 
made  on  the  basis  of  the  information  to  be  sought  from  the  Member  States  Competent 
Authorities (CAs). 

1 

OJ L 268, 3.10.1998, p. 1 

3 

 
 
  
 
                                                 
1. 

INTRODUCTION 

Influenza  pandemics  are  likely  to  have  severe  public  health  and  economic 
implications.  In  1918,  the  pandemic,  so-called  “Spanish  flu”  due  to  the  death  of  a 
member  of  the  Spanish  Royal  Family  and  intense  reporting  by  the  Spanish  media, 
caused  about  20  million  deaths  worldwide.  On  average  pandemics  causing  high 
morbidity  and  mortality  have  occurred  every  25  years  during  the  last  century, 
whereas the last pandemic took place more than 30 years ago. 

An influenza pandemic may be described as an epidemiological event characterised 
by  the  global  circulation  of  a  new  virus  sub-type  in  humans  with  no  or  little 
immunity,  or  of  a  virus  causing  morbidity  and  mortality  that  significantly  exceed 
average seasonal epidemic rates. 

Since influenza outbreaks occur regularly every year, it is extremely important to be 
able to judge whether they could reach severe epidemic proportions and eventually 
develop into pandemics. This calls for appropriate vigilance and for microbiological 
and  epidemiological  surveillance  systems  that  can  provide  accurate  predictions  and 
timely warnings. 

In  preparation  for  influenza  pandemics,  certain  Member  States  have  developed 
systems  of  national  influenza  pandemic  planning  based  on  the  WHO  guidelines 
adopted  in  1999.  Because  of  the  characteristics  of  pandemics,  however,  and  the 
special features of the European Union area in which people, animals and products 
circulate  freely,  the  question  of  the  need  for  Community  action  to  co-ordinate 
preparedness and response in the EU had become critical. 

To  address  it,  the  Commission  organised  a  conference  on  influenza  pandemic 
preparedness  planning  in  November  2001  in  Brussels  at  which  delegates  from  the 
Member States and accession countries, independent experts  and stakeholders from 
Europe and overseas countries participated. The delegates recognised and agreed on 
the  need  for  Community  action.  The  conference  concluded  with  recommendations 
for core actions at Community  level, which  form  the  key  elements of  the proposed 
Community Influenza Preparedness and Response Plan, hereinafter referred to as the 
“preparedness plan”, presented in this working paper. The preparedness plan further 
develops certain elements of the guidelines adopted by the WHO in 1999. 

In parallel, extensive consultations on pandemic influenza were undertaken with the 
members of the Network Committee and with an ad hoc working group on influenza 
set  up  to  advise  the  Commission  services.  The  WHO  and  the  European  Medicines 
Evaluation Agency (EMEA) have been closely associated with these consultations. 

The  working  paper  was  drawn  up  on  the  basis  of  the  aforementioned  actions  and 
considered and reviewed at a meeting in October 2003 of the PRPG. This group has 
been set up to advise the Commission services on matters concerning public health 
emergencies following the request of the Health Ministers to the Commission, in the 
light of the SARS outbreak, to develop a general plan for public health preparedness 
and response to health threats whatever their provenance. 

From the animal health point of view, which is a crucial factor because of the direct 
links with human influenza, it should be pointed out that, in pursuance of Directive 

4 

 
 
  
 
92/40/EEC2  introducing  Community  measures  for  the  control  of  avian  influenza, 
contingency  plans  for  this  disease  have  been  developed,  approved  by  the 
Commission and implemented by Member States CAs in the event of outbreaks. 

Furthermore,  in  2003,  the  Commission  endorsed  a  survey  on  avian  influenza  in 
domestic  poultry  and  wild  birds  in  the  Member  States.  First  results  are  already 
available. Based on the results of this survey, the Commission intends to propose a 
strengthened  approach 
reinforced 
influenza 
surveillance, which also takes account of public health aspects related to prevention 
and  disease  transmission  from  poultry  to  humans.  The  current  avian  influenza  in 
Asia,  on  which  a  series  of  measures  have  been  taken,  provides  a  further 
demonstration of the need for rigorous methods and practices in this area. 

infections, 

to  avian 

including 

2. 

PRINCIPLES, OBJECTIVES AND COMPONENTS OF THE PREPAREDNESS PLAN 

Experience has shown that the ability to respond to an international threat to health is 
profoundly  influenced  by  the  extent  to  which  the  issues  have  been  considered  in 
advance and plans are in place for co-ordinated action. 

Detailed guidance on national preparedness plans is contained in the WHO document 
‘Influenza  Pandemic  Plan.  The  Role  of  WHO  and  Guidelines  for  National  and 
Regional Planning’ (WHO Geneva, 1999)3. The document was taken into account for 
the preparation of this paper, which addresses the planning needed for the European 
Community to respond effectively to a potential or actual pandemic of influenza. 

The purpose of the preparedness plan would be to minimise the risk of a pandemic, 
to  ensure  preparedness  and  to  achieve  a  co-ordinated  Community  response  in  the 
event of an influenza pandemic through: 

– 

– 

– 

Identification of the key components of the response. 

Identification of those activities of the Commission, the European Agency for 
the  Evaluation  of  Medicinal  Products  (EMEA)  and  the  Member  States  that 
could facilitate and help co-ordinate countermeasures. 

Setting  the  Community  response  in  the  context  of  the  wider  international 
response  through  co-operation  with  international  organisations  such  as  the 
WHO. 

The main objectives of the preparedness plan are: 

– 

– 

Facilitate a timely response. 

Contribute  to  reducing  vulnerability  of  public  health,  particularly  limiting 
excess morbidity/mortality. 

– 

Help to reduce fear in the population, including healthcare professionals. 

2 
3 

OJ L 167, 22.6.1992, p. 1 
http://www.who.int/csr/resources/publications/influenza/WHO_CDS_CSR_EDC_99_1/en/, 
17.11.2003 

accessed 

5 

 
 
  
 
                                                 
– 

– 

Limit disruption to normal activities as far as possible. 

Reduce potential conflicts between different national plans. 

The  preparedness  plan  put  forward  in  this  paper  comprises  the  following 
components: 

– 

– 

– 

A  division  of  the  influenza  “cycle”  into  pre-defined  phases  and  levels,  which 
have to be recognised on the basis of agreed criteria and which act as triggers 
for countermeasures by the Commission and by the Member States. 

A  set  of  key  functions  that  need  to  be  discharged  properly  if  influenza 
pandemics  are  to  be  tackled  effectively.  Management  and  co-ordination, 
surveillance,  prevention  and 
intervention  strategies,  civil  protection, 
communication  and  research  are  the  key  functions  covered  under  the 
preparedness plan. 

The  establishment  of  Community-level  mechanisms  to  ensure  that  there  is 
effective  co-ordination  and  joined-up  action  at  every  stage  of  an  influenza 
outbreak that risks developing into a pandemic: 

– 

– 

– 

Firstly,  for  management  and  co-ordination,  the  Community  can  use  the 
mechanisms provided by Decision 2119/98/EC4, namely the adoption of 
Commission  decisions  following  a  positive  opinion  from  the  Network 
Committee for measures such as the declaration of a pandemic situation 
and  mandatory  consultation  procedures,  and  for  co-ordination  of 
measures as provided by Commission Decision 2000/57/EC5 on the early 
warning  and  response  system  for  the  prevention  and  control  of 
communicable  diseases.  Secondly,  the  Commission  services  will  be 
advised  by  the  PRPG  on  the  appropriate  actions  to  be  considered.  The 
PRPG is composed of experts designated by the Member States and will 
be convened according to the guidelines set out in the preparedness plan. 

In  the  context  of  intervention  strategies,  retrospective  evaluation  of  the 
experience  gained  during  serious  outbreaks  of  communicable  diseases 
outside  the  European  Union  has  illustrated  the  need  for  a  consensus  on 
the  co-ordination  of  international  outbreak  investigations.  Such  co-
ordination is equally useful for outbreaks within the EU. In order to meet 
this  need  it  is  proposed  that  an  Outbreak  Assistance  Team  (OAT)  be 
assembled and activated on advice from the PRPG. 

surveillance, 

exist,  namely 

appropriate  mechanisms 

For 
the 
Communicable  Disease  Surveillance  and  Response  Network  and  the 
avian influenza surveillance scheme on domestic poultry and wild birds 
co-ordinated  by  the  Community  Reference  Laboratory  for  Avian 
Influenza.  They  should  be  complemented  by  a  Community  Network  of 
laboratories  for  human  influenza,  because  effective  surveillance  at 
Community level depends on the expertise and capacity of laboratories in 
the  Member  States  to  detect  potentially  dangerous  influenza  viruses  in 

4 
5 

OJ L 268, 3.10.1998, p. 1 
OJ L 21, 26.1.2000, p. 32 

6 

 
 
  
 
                                                 
good  time.  Surveillance  data  should  include  information  on  strains  in 
humans  and  animals,  the  burden  of  disease  and  vaccination  coverage, 
effectiveness and safety. 

– 

The  encouragement  of  specific  prevention  measures.  In  the  event  of  a 
pandemic,  the  swift  development  and  distribution  of  new  vaccines  and 
availability  of  antivirals  will  be  of  utmost  importance  in  tackling  the 
disease.  Equity  of  access  to  these  medicines  is  a  pre-requisite  and,  for 
new  vaccines,  timely  delivered  guidelines  will  be  crucial  in  order  to 
reduce the time needed for their marketing authorisation. Stockpiling of 
antivirals  to  cover  the  lead  time  needed  to  develop  and  produce  new 
vaccines should be encouraged. 

3. 

PHASES AND LEVELS 

The WHO has suggested various criteria to define phases in line with the unfolding 
epidemiological  situation  of  a  pandemic.  In  addition,  the  definition  of  levels  of 
preparedness provides a basis for WHO to determine its response to such situations 
as they are assessed on the basis of the occurrence of specific events and associated 
risks, as indicated in the table below. The classification system used in this document 
is  based  on  the  WHO  classification  and  is  consistent  with  the  criteria  adopted  in 
other  areas  of  work  at  Community  level,  such  as  the  marketing  authorisation  for 
medicinal products for human use and veterinary medicinal products, generic public 
health  emergency  plans  and  smallpox  preparedness  planning,  which  take  into 
account  the  specificity  of  the  EU.  In  particular,  the  recognition  of  a  pandemic 
situation can be made in the context of Decision 2119/98/EC. For medicinal product 
marketing purposes, such recognition will be based either on a pronouncement of the 
WHO or by the Community in the framework of Decision 2119/98/EC, as laid down 
in  Commission  Regulation  (EC)  No  1084/20036  concerning  the  examination  of 
variations to the terms of a marketing authorisation for medicinal products for human 
use  and  veterinary  medicinal  products,  and  in  Commission  Regulation  (EC) 
No 1085/20037 concerning the examination of variations to the terms of a marketing 
authorisation  for  medicinal  products  for  human  use  and  veterinary  medicinal 
products  falling  within  the  scope  of  Council  Regulation  (EEC)  No 2309/93.  The 
classification  system  used  is  given  in  the  following  table  which  sets  out  best  and 
worst case scenarios for the EU and also shows the correspondence with the WHO 
phases and levels. 

6 
7 

OJ L 159, 27.06.2003, p. 1 
OJ L 159, 27.06.2003, p. 24 

7 

 
 
  
 
 
 
 
                                                 
Table of correspondence 

EU 

Criteria: origin of outbreak 

WHO 

Criteria 

Phase  Level  Outside EU 

Inside EU 

Phase  Level 

0 

1 

2 

3 

No  indications  of  any  new 
virus 
in 
humans 

reported 

type 

Isolation  of  novel  sub-type 
from a single human case 

Two 
human 
or  more 
infections  with  a  new  sub-
type 

Human 
transmission confirmed 

to 

human 

: 

Confirmation  of  onset  of 
pandemic 
several 
outbreaks  in  at  least  one 
country,  spread 
to  other 
countries 

Regional 
regional epidemics  

and 

multi-

0 

1 

2 

3 

0 

0 

0 

0 

1 

2  

0 

2  

1 

2 

2 

2 

3 

No indications of any new 
virus 
in 
humans 

reported 

type 

Isolation  of  novel  subtype 
from a single human case  

No  indication  of  any 
new 
type 
virus 
reported in humans  

Isolation  of  novel 
subtype  from  a  single 
human case 

Two  or  more  human 
infections with a new sub-
type 

Two  or  more  human 
infections  with  a  new 
subtype 

0 

0 

0 

human 

0 

Human 
to 
transmission 
confirmed  

Several  outbreaks  in 
at  least  one  Member 
State,  spread  to  other 
countries 

Regional  and  multi-
regional  epidemics  in 
the EU  

1 

2 

Human 
transmission confirmed  

to 

human 

Several  outbreaks 
in  at 
least  one  country  outside 
other 
EU, 
countries  

spread 

to 

and  multi-
Regional 
epidemics:  no 
regional 
indications  of  any  new 
virus  type  reported  in  the 
EU  

and  multi-
Regional 
regional 
epidemics: 
isolation  of  novel  subtype 
from  a  single  human  case 
inside EU 

Regional 
and  multi-
regional epidemics: two or 
more  human 
infections 
with  a  new  subtype  inside 
EU 

Human 
human 
to 
transmission  with  new 
subtype  confirmed  inside 
EU 

Regional  and  multi-
regional  epidemics  in 
the EU  

2  

Regional 
regional epidemics:  

and 

multi-

Regional  and  multi-
regional  epidemics  in 
the EU  

Regional  and  multi-
regional  epidemics  in 
the EU 

2 

2 

Regional 
regional epidemics  

and 

multi-

Regional 
regional epidemics:  

and 

multi-

2 

3 

4 

5 

4 

Outbreaks  in  one  or  more 
Member States 

Regional  and  multi-
regional  epidemics  in 
the EU 

End  of  the  first  pandemic 
wave 

End  of 
the 
pandemic wave 

first 

3  

End  of  the  first  pandemic 
wave 

Second  or  later  waves  of 
the pandemic 

Second or later waves 
of the pandemic 

End of the pandemic (back 
to phase 0) 

End  of  the  pandemic 
(back to phase 0) 

4  

5  

Second  or  later  waves  of 
the pandemic 

End  of  the  pandemic  (back 
to phase 0)  

8 

 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4. 

THE COMMISSION AND THE MEMBER STATES: MAIN TASKS AND ROLE 

The tasks required in each phase and at each threat 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  from  one  stage  of 
activity  to  a  subsequent  one  may,  however,  need  to  be  rapid,  depending  on  the 
evolution of events, and certain phases or levels may have to be leapfrogged. Plans 
need to be flexible to allow for this contingency. The objectives in each of the main 
functions  to  be  discharged  as  the  epidemiological  situation  develops  are  set  out 
below. 

4.1.  Management and co-ordination 

4.1.1.  Main objectives 

All phases and levels: 

– 

– 

Further  develop  and  update  the  Community  preparedness  and  response  plan, 
emphasising the added value to the European Community; 

Ensure  that  national  pandemic  preparedness  and  response  plans  are  well  co-
ordinated and regularly updated. 

Phase 0, level 3 and subsequent phases: 

Agree  guidelines  for  advice  to  travellers,  air  and  other  transport  staff  likely  to  be 
occupationally exposed, health care staff and the public. 

Phase 2, levels 3 and 4 and subsequent phases: 

Co-ordinate  measures  to  be  taken  by  the  Member  States  and  ensure  their  inter-
operability. 

4.1.2.  Role of the Commission and the Member States 

EU  added  value  can  be  achieved  by  improving  co-ordination  and  communication 
among the Member States and with the WHO. A two-tiered structure is proposed: 

Public Health Preparedness and Response Planning Group (PRPG): 

The PRPG has already been established. It is modelled on its predecessor group set 
up  under  the  Health  Security  Committee  for  deliberate  releases  of  biological  and 
chemical  agents  and  draws  on  the  experience  gained  during  the  SARS  epidemic  in 
the framework of the Experts Group on SARS. The tasks of the PRPG are: 

– 

– 

– 

Provide advice on risk assessment. 

Recommend actions to be taken. 

Communicate  and  review  existing  national  preparedness  and  response  plans 
and provide advice on gaps and co-ordination needs between national plans. 

9 

 
 
  
 
– 

– 

– 

– 

Share expertise and good practice with other groups working on preparedness 
plans for comparable health. 

Establish and regularly update a list of Community experts in appropriate areas 
of interest. 

Set up groups to advise on contingency planning for particular diseases. 

Advise on: 

– 

– 

– 

– 

The  activation  of  an  OAT  by  the  Commission  in  consultation  with  the 
Member States under defined terms of reference.; 

The development, use and monitoring of use of medicinal products. 

Detection and diagnostic capacity. 

Community  surveillance  schemes  on  human  and  animal  influenza;  the 
EMEA and the WHO will be fully involved in the work of the group. 

Outbreak Assistance Team (OAT) 

A mechanism to establish and activate an OAT consisting of experts drawn from a 
list  established  in  conjunction  with  the  Member  States  will  be  created  by  the 
Commission in collaboration with the Member States. The team should work with an 
agreed  mandate, organisation,  structure, and detachment procedures. The  full range 
of tasks of the team may vary according to the terms of reference to be defined by the 
PRPG, but would include the following: 

– 

– 

– 

Participation in outbreak investigation inside and outside the Community in co-
operation with the WHO. 

Provision  of  assistance  in  risk  assessment  and  co-ordination  of  activities  on 
site. 

Provision of expertise and consultancy to national/local health authorities and 
the Commission services. 

– 

Reporting on request to the PRPG. 

4.2. 

Surveillance 

4.2.1.  Objectives 

Phase 0, level 1: 

Recognise new virus type. 

Phase 0, level 2: 

Ensure confirmation of the strain and identification of its source. 

Phase 0, level 3: 

10 

 
 
  
 
Begin intensive surveillance; 

Ensure  rapid  transmission  of  information  on  transmission  characteristics  with  the 
WHO and country(ies) affected. 

Phase 1, Phase 2, levels 1 and 2: 

Ensure  sharing  of  information  on  epidemiological  surveillance  data  with  the  WHO 
and the countries affected. 

Phase 2, levels 3 and 4 and subsequent phases: 

Continue  clinical  surveillance  to  provide  essential  information  on  the  extent  and 
burden of illness and the causes of complications. 

Continue sufficient virological surveillance to check on the spread and evolution of 
the virus, including antiviral susceptibility. 

4.2.2.  Role of the Commission and the Member States 

The  most  important  task  of  surveillance  by  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.  

The  Commission  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.  To  this  end,  Dedicated 
Surveillance  Networks  (DSNs)  have  been  developed.  They  function  in  accordance 
with  Commission  Decision  2003/542/EC8  amending  Decision  2000/96/EC9  as 
regards  the  operation  of  dedicated  surveillance  networks.  The  influenza  case 
definitions  to  be  used  for  reporting  are  laid  down  by  Commission  Decision 
2003/534/EC10 amending Decision No 2119/98/EC of the European Parliament and 
of the Council and Decision 2000/96/EC as regards communicable diseases listed in 
those  decisions  and  amending  Decision  2002/253/EC11  as  regards  the  case 
definitions for communicable diseases.  

In its efforts to develop a wide basis for action in the Community, the Commission 
has financially supported the European Influenza Surveillance Scheme (EISS) since 
1999 under the terms of Decision No 647/96/EC12 of the European Parliament and of 
the Council adopting a programme of Community action on the prevention of AIDS 
and certain other communicable diseases within the framework for action in the field 

8 
9 
10 
11 
12 

OJ L 185, 24.7.2003, p. 55 
OJ L 028, 3.2.2000, p. 50 
OJ L 184, 23.7.2003, p. 35 
OJ L 86, 3.4.2002, p. 44 
OJ L 95, 16.4.1996, p. 16 

11 

 
 
  
 
                                                 
of  public  health  (1996  to  2000).  Decision  No  1786/2002/EC13  of  the  European 
Parliament  and  of  the  Council  adopting  a  programme  of  Community  action  in  the 
field  of  public  health  (2003-2008)  provides  the  current  basis  for  funding  of 
surveillance  schemes.  The  co-operation  represented  by  such  schemes  is  crucial  for 
Community preparedness planning to ensure rapid information on influenza activity 
in Europe, in close co-operation with Member States and international organisations 
such as the WHO. The scheme communicates information on epidemics, in particular 
on  situations  with  the  potential  for  an  imminent  pandemic,  to  the  Communicable 
Disease Surveillance and Response Network without delay. Data should be analysed 
and presented in a way that can easily be interpreted by the general public and policy 
makers. Secured pathways for reporting are essential for maintaining surveillance in 
a crisis situation. 

Surveillance  of  influenza  infections  in  animals,  in  particular  in  bird  populations,  is 
important, as birds may harbour a great variety of influenza virus strains. Based on 
the experience gained from the EU-wide survey on domestic poultry and wild birds 
mentioned above, 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 public 
health  actions.  High  coverage  of  virological  surveillance  is  technically  and 
economically  feasible  within  the  European  Union  and  could  be  achieved  by 
supporting  a  network  of  reference  laboratories  and  surveillance  systems  in  the 
Member  States.  Clinical  surveillance  of  human  cases  should  include  age-specific 
morbidity  and  mortality,  and  possibly  also  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  composition  of  vaccines  varies  from  year  to  year.  More  emphasis  should  be 
placed  on  systematic  surveillance  of  the  impact  of  vaccination  programmes  on 
morbidity and mortality. 

Under the terms of Proposal for a Regulation of the European Parliament and of the 
Council  establishing  a  European  Centre  (for  Disease  Prevention  and  Control), 
presented  by  the  Commission  (COM(2003)441  final,  2003/0174  COD)  the  ECDC 
would  be  expected  to  assume  all  tasks  related  to  the  epidemiological  surveillance 
under  the  plan,  to  take  part  in  the  organisation  and  conduct  of  influenza  outbreak 
assistance, and to provide advice on options and guidelines for appropriate responses 
in the various phases and levels contained in the plan. 

Serological studies* 

In  addition  to  clinical  and  virological  surveillance,  serological  studies  would  also 
have to be carried out. During a pandemic, serological studies should be done at the 
beginning  of  the  first  wave  and  at  the  end  of  phase  2  to  predict  morbidity  and 
mortality in the age groups that will be hit the most severely by the pandemic strain. 

13 
* 

OJ L 271, 9.10.2002, p. 1 
A  branch  of  laboratory  medicine  concerned  with  the  analysis  of  the  contents  of  the  blood  serum,  in 
which antibodies to infectious diseases are detectable 

12 

 
 
  
 
                                                 
These data should serve as a basis for realistic estimates of the need for vaccines and 
antivirals.  

Plans  should,  therefore,  be  in  place  to  evaluate  at  Community  level  the  serological 
status of population groups to specified influenza viruses. 

Laboratory preparedness 

The  capability  of  laboratories  to  ensure  early  detection  of  the  circulation  of  a 
pandemic strain is the key to virological surveillance. 

Laboratory capabilities within Member States are essential for the early detection of 
the  pandemic  strain  and  for  establishing  the  epidemiological  situation.  In  each 
Member  State  there  should  be  at  least  one  laboratory  that  collaborates  with  health 
care facilities to obtain samples from suspected cases and collects viruses isolated in 
other diagnostic laboratories. It should also be able to determine the characteristics of 
the  virus.  The  delay  between  the  time  the  sample  is  taken  and  reporting  must  be 
short.  The  national  reference  laboratories  should  be  designated  by  Member  State 
competent  authorities,  and  be  recognised,  where  appropriate,  by  the  WHO  Global 
Influenza Programme as National Influenza Centres. 

Together,  under  the  co-ordination  of  the  Commission  and  in  conjunction  with  the 
Communicable  Disease  Surveillance  and  Response  Network,  these  laboratories 
should form the Community network of reference laboratories for human influenza. 
Within this network, individual laboratories would contribute to the network in their 
respective  fields  of  expertise  in  surveillance  and  research.  Information,  capabilities 
and  materials  should  be  shared  in  a  way  that  ensures  a  uniformly  high  quality  of 
virological surveillance throughout the EU. 

In animal health, a Community Reference Laboratory for Avian Influenza has been 
established since 1992. It works closely together with the National Avian influenza 
Laboratories. In the future, co-operation must also be established between the animal 
and human influenza laboratories in the whole of the EU. 

Vaccine coverage, effectiveness and safety 

Monitoring  of  vaccination  coverage,  effectiveness  and  safety  for  a  new  pandemic 
vaccine  would  have  to  be  bolstered  through  surveys  of  target  groups.  Vaccine  side 
effects should be monitored by the EISS. 

4.3. 

Prevention, Mitigation and Response 

4.3.1.  Objectives 

Phase 0, level 0: 

Build up experience of handling influenza outbreaks and epidemics through routine 
programmes; 

Establish co-operation links with and ensure training of health professionals. 

Phase 0, level 1: 

13 

 
 
  
 
Initiate  action  to  develop candidate vaccine strains in collaboration with the WHO, 
the EMEA and vaccine manufacturers. 

Phase 0, levels 2 and 3, Phase 1: 

Help implement mitigation and response strategies in affected countries. 

Subsequent phases until the end of the pandemic: 

Initiate action to issue clear guidance on use of vaccines and antivirals with a view to 
ensuring equity of access. 

Implement  vaccination  plans,  mitigation  strategies  involving  care  and  use  of 
antivirals and antibiotics where appropriate. 

4.3.2.  Role of the Commission and the Member States 

The risk groups for vaccination may be different from normal, i.e. young people may 
be at risk if a virus similar to the pandemic virus has circulated previously and older 
people retain some immunity. Furthermore, when vaccine is in short supply, priority 
may be given to maintaining essential services and reducing social disruption. Each 
Member State should prepare plans for vaccinating priority groups. The Commission 
could  facilitate  co-ordination  of  plans  to  ensure  inter-operability  and  to  avoid 
confusion and public concern over the level of health protection afforded in various 
parts of the EU. 

Antivirals may provide some protection before 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.  The 
Commission  could  facilitate  the  exchange  of  information  and  sharing  of  good 
practice in this area. 

Needs  and  capacities  for  vaccines,  antivirals  and  antibiotics  in  the  event  of  a 
pandemic 

During inter-pandemic periods, manufacturers of vaccines, antivirals and antibiotics 
produce  doses  to  meet  forecasted  market  needs.  Manufacturing  capacity  within  the 
Community and in companies supplying the Community is not generally known, but 
it  is  not  likely  to  be  sufficient  to  meet  the  demands  during  a  pandemic.  Recent 
advances  in  production  techniques  using  cell  cultures  and/or  reverse  genetics  may 
enhance production in such situations. 

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, antivirals 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. 

14 

 
 
  
 
– 

– 

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. 

Community plan for co-ordinated production, distribution and use of vaccines 
and antivirals 

Currently inactivated virus vaccines are produced in fertile chicken eggs, which must 
be  ordered  many  months  in  advance.  Vaccines  are  recommended  for  groups  of  the 
population  considered  to  be  at  risk.  Within  the  Community  there  are  only  five 
Member  States  with  resident  vaccine  manufacturers  and  some  vaccine  used  in  the 
Community  is  produced  outside.  At  present,  vaccine  is  available  to  all  Member 
States  under  commercial  agreements.  Influenza  antiviral  agents  (M2  inhibitors  and 
neuraminidase inhibitors) are widely licensed in the Community, but their use is not 
widespread. 

In the event of a pandemic: 

There  are  certain  constraints  to  vaccine  production  and  availability.  Candidate 
vaccine strains may be derived from animals. It is imperative that the application of 
veterinary  import  controls  does  not  jeopardize  or  unnecessarily  delay  rapid 
distribution and use of viral strains in the Member States Moreover, vaccines may be 
needed  outside  the  normal  production  season  when  eggs  are  in  short  supply.  This 
could seriously delay vaccine availability. 

It  may  take  at  least  2-3  months  but  probably  significantly  longer  to  develop  a  safe 
vaccine strain, and possibly even longer if the pandemic virus is highly pathogenic. 
Time could, however, be saved by prioritization of virus sub-types from a library of 
reagents,  to  be  produced  in  advance  by  the  Community  Network  of  Reference 
Laboratories  for  Human  Influenza  operated  by  the  EISS  in  conjunction  with  the 
WHO  to  represent  all  known  influenza  subtypes.  Such  a  vaccine  could  be  used  to 
combat the first wave of a pandemic, before vaccine is available from the pandemic 
virus. 

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. 
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. Measures should not, however, 
include the promotion of any behaviour in breach of EU competition rules. 

Marketing authorisation of pandemic influenza vaccines 

The  current  Community  procedures  for  the  marketing  authorisation  of  medicinal 
products  include  a  Centralised  procedure,  involving  the  EMEA,  and  a  Mutual 
Recognition procedure, managed and co-ordinated by the Member States CAs. The 
Centralised procedure is, however, mandatory for medicinal  products developed by 
means of DNA-recombinant techniques, such as reverse genetics.  

15 

 
 
  
 
Changes  to  the  composition  of  the  vaccines,  e.g.  change  of  the  vaccine  strain  are 
made through a variation to the terms of an existing marketing authorisation, which 
can take up to 90 days depending on the type of variation. 

In a pandemic situation, speed in vaccine development, authorisation and distribution 
will  be  crucial.  Specific  legal  provisions  to  tackle  this  are  outlined  in  Article  8  of 
Commission  Regulations  1084/200314  and  1085/200315.  Detailed  guidance 
documents have been drafted by the EMEA and the Commission, to explicitly define 
how a marketing authorisation application for a pandemic influenza vaccine should 
be submitted16. 

The proposed approach is a two-steps one, based on the concepts of a core pandemic 
dossier and a pandemic variation: 

A  core  pandemic  dossier  is  submitted  and  approved  during  the  inter-pandemic 
period, the period between two pandemics. This dossier should enable all parameters 
which do not specifically depend on the pandemic, such as production processes and 
testing  strategies,  to  be  validated  prior  to  the  pandemic  situation.  A  “mock-up” 
vaccine, ideally having the same characteristics as the intended pandemic vaccine, is 
to be tested in this context. This “mock-up” vaccine would not be marketed until a 
pandemic situation occurs in the Community and a variation application containing 
all relevant information on the specific pandemic strain is filed. 

When the pandemic situation occurs, a pandemic variation would be submitted. This 
variation would contain only data that are new and relevant for the pandemic strain. 
The  assessment  and  authorisation  of  this  variation  would  be  done  in  a  ‘fast-track’ 
procedure. 

In order to increase the preparedness of both the industry and competent authorities 
for a possible influenza pandemic, a joint EMEA-Industry Task Force (JEIF) will be 
set  up.  This  JEIF  would  involve  experts  from  the  competent  authorities,  WHO, 
representatives from the European Directorate for the Quality of Medicines (EDQM) 
and 
(OMCLs),  Commission 
representatives,  manufacturers  of  influenza  vaccines,  and  EMEA  staff.  The  group 
would  meet  on  a  regular  basis,  to  provide  information  and  advice  to  regulatory 
authorities, review the status of preparedness of vaccine manufacturers, and discuss 
quality, safety and efficacy aspects of pandemic influenza vaccines. 

the  Official  Medicines  Control  Laboratories 

In  the  event  of  a  pandemic  situation,  other  task  forces  specifically  dedicated  to  the 
scientific evaluation of new pandemic influenza candidate vaccines may have to be 
set up as well. 

4.4. 

Communication 

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 very good and perfectly co-
ordinated communication to the general public and to the media. 

14 
15 
16 

OJ L 159, 27.6.2003, p. 1 
OJ L 159, 27.6.2003, p. 24 
EMEA/CPMP/4986/03 & EMEA/CPMP/4717/03, Réf.:http://www.emea.eu.int/indem/indexh1.htm 

16 

 
 
  
 
                                                 
Even at threat level 0 or  1 of phase 0, the perceived threat of a  pandemic can give 
rise  to  considerable  media  interest.  Making  reliable  information  about  the  threat 
available should be a key priority of Member States 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 should develop a range 
of ready to use media briefing materials about influenza. These would, for example, 
give 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. Communication strategy needs to be considered early 
on  in  the  process  of  addressing  a  potential  pandemic.  Member  States  and  the 
Commission  should  endeavour  to  co-ordinate  common  messages  and  statements  to 
the  media  about  the  threat  and  the  planned  measures  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  for  the  Commission,  during  a  pandemic,  to 
publish daily reports on the Internet on influenza cases around Europe reported to the 
Communicable  Disease  Surveillance  and  Response  Network.  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  some  level  of  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. 

At threat levels 3 and 4 of phase 2 and in subsequent phases, there is a need to define 
explicit communication tasks to the PRPG and to the OIT. It would also be necessary 
to  define  adequate  tools  and  clarify  responsibilities  between  the  communication 
performed by this structure and by the Commission and the Member States. 

4.5. 

Civil Protection 

A  Community  Mechanism  to  facilitate  reinforced  cooperation  in  civil  protection 
assistance interventions has been established under Council Decision 2001/792/EC17. 

Within  this  framework,  assistance  may  be  provided  to  requesting  Member  States, 
Acceding  and  EEA/EFTA  Countries  in  the  event  of  a  pandemic  with  serious 
consequences requiring the activation of civil protection emergency plans. 

17 

OJ L 297, 15.11.2002, p. 7 

17 

 
 
  
 
                                                 
4.6. 

Research 

The research components of various Community actions have already been identified 
in  the  Community’s  6th  Framework  Programme.  Research  performed  during  the 
inter-pandemic period is vital for preparing for effective pandemic response. 

Research  leading  to  the  development  of  new  vaccine  technology  should  remain  a 
priority  and  be  linked  to  routine  and  fast-track  licensing  procedures  for  influenza 
vaccines. 

Current and emerging anti-viral drug resistance developments in influenza need to be 
addressed through coordinated research at the European level18. 

Furthermore,  in  the  process  of  early  recognition  of  the  identity  and  origins  of 
pandemic  strain,  the  role  of  international  scientific  cooperation  is  key.  The 
Commission will therefore continue to develop its collaborative research networks to 
integrate partners in third countries, as was the case in the past with similar threats, 
such as Ebola and Lassa fever and more recently SARS. 

5. 

PREPAREDNESS AND RESPONSE TO INFLUENZA PANDEMICS : MAIN ACTIONS 

The key actions to be planned and implemented in regard to influenza pandemics can 
be  grouped  under  the  phases  and  levels  presented  in  chapter  3.  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  to  be  advised  by  the  PRPG  following  the  assessment  of  the 
epidemiological  situation  on  the  basis  of  the  criteria  set  out  in  the  table  of 
correspondence. 

18 

A  total  of  9  million  €  has  been  allocated  from  the  6the  Framework  programme  to  set  up  a  vigilance 
research network for the management of anti-viral drug resistance in influenza and viral hepatitis B and 
C. The proposal is currently under negotiation with contract launch foreseen during spring 2004. 

18 

 
 
  
 
                                                 
Phase 0, level 0: 

Commission 

Maintain  records  of  status  of  Member  States  pandemic  preparedness  and  response 
plans. 

Review the possible legislative restrictions on the transport of virus strains or isolates 
necessary  for  vaccine  production  across  Member  States  and  consider  and  prepare 
ways to ease them for the purpose of public health protection. 

Establish an inventory of Community experience of reverse genetics techniques. 

Explore  possibilities for  an accelerated central authorisation procedure for vaccines 
and  analyse  the  implications  of  new  vaccine  production  technologies  on  vaccine 
licensing and quality assessment. 

Address  issues  of  research  and  development,  authorisation  and  availability  of  new 
vaccines  through  the  Commission  Pharmaceutical  Committee  set  up  by  Council 
Decision 75/320/EEC.19 

Examine  the  feasibility  of  setting  up  a  mechanism  for  co-ordinated  production, 
distribution,  stockpiling  and  use  of  vaccines,  antivirals  and  antibiotics  ensuring 
equity of distribution at Community level in the event of a pandemic. 

Prepare  some  ready  to  use  media  briefing  materials  on  influenza.  These  should,  in 
particular,  give  basic  information  about  the  EU’s  role  in  responding  to  a  major 
influenza outbreak. 

Member States 

Complete, review, update and implement national influenza pandemic preparedness 
and response plans. 

Establish  a  National  Pandemic  Planning  Committee  (NPPC)  to  advise  on  influenza 
pandemic measures. 

Competent  authorities  to  designate  National  Reference  Laboratories  for  Human 
Influenza  to  be  recognised,  where  applicable,  by  the  WHO’s  Global  Influenza 
Programme  as  National  Influenza  Centres,  and  inform  the  Commission  on  such 
designations. 

Achieve  high  vaccine  coverage,  in  particular  in  vulnerable  groups,  such  as  health 
care  workers  and  the  elderly,  in  line  with  paragraph  1  of  the  Resolution  of  the 
Executive  Board  of  the  WHO  of  23  January  2003  on  Prevention  and  control  of 
influenza pandemics and annual epidemics20. 

Prepare  some  ready  to  use  media  briefing  materials  on  influenza.  These  should,  in 
particular, give some information on the national preparedness plans. 

19 
20 

OJ L 147, 9.6.1975, p. 23 
http://www.who.int/gb/EB_WHA/PDF/EB111/eeb111r6.pdf, accessed 17/11/2003 

19 

 
 
  
 
                                                 
Commission and Member States 

Establish  a  Community  Network  of  Reference  Laboratories  for  Human  Influenza 
within influenza surveillance schemes in the Community and develop a protocol for 
sending appropriate specimens. 

Maintain  an  inventory  of  laboratory  capacities  and  facilities  available  at  national 
level in the Member States. 

Strengthen  co-operation  of  Community  surveillance  systems  on  human  influenza 
with influenza surveillance networks operating outside the Community. 

Create and maintain links between human and veterinary surveillance systems. 

Improve ongoing clinical, epidemiological and virological surveillance, building on 
existing structures. 

Co-operate with the WHO and the EMEA on the development of new vaccines. 

Maintain continuous dialogue with the pharmaceutical industry;  

Improve  surveillance  of  vaccination  coverage  and  effectiveness  in  the  current 
priority groups during the inter-pandemic phase. 

Evaluate pandemic plans and co-ordination during pandemics. 

Support  the  modelling  of  pandemics  through  EU-wide  exercises  and  define, 
characterise and monitor different high-risk groups according to different scenarios. 

20 

 
 
  
 
Phase 0, levels 1, 2 and 3; Phase 1: 

Commission 

Convene as appropriate the PRPG to consider and agree on guidelines. 

Maintain  regular  contact  with  the  WHO  and  provide  assistance  for  outbreak 
investigation, including that involving the OAT, if requested by the WHO. 

Jointly with EMEA : 

Convene a meeting of the JEIF after the announcement of Phase 0, level 3. Issues to 
be  discussed  at  this  meeting  should  include:  identification  of  the  manufacturers  of 
pandemic vaccines and production capacities, status of the marketing authorisations 
and  timelines  for  submissions  of  pandemic  variations,  status  report  on  the  official 
release testing of the pandemic influenza vaccine batches. 

Manage  and  coordinate  the  fast-track  assessment  of  the  submitted  variation 
application, as soon as the timeline for submission of a pandemic variation is known. 

Member States 

Review  and  update  the  national  pandemic  preparedness  and  response  plans,  where 
appropriate, following advice by the National Pandemic Planning Committee. 

Provide, if requested by a Member State, assistance for any further investigation, in 
accordance with the provisions of Annex II to Commission Decision 2000/57/EC. 

Ensure laboratories involved in typing viruses review their techniques and materials, 
and prepare status report of reagents and diagnostic capability for novel subtypes. 

Institute virological sampling in areas where the population may have travel-related 
contact with the site of initial identification of the novel virus. 

Report  possible  clusters  or  outbreaks  of  influenza-like  illness  and  clinical  and 
epidemiological characteristics of the new influenza subtype using the Community’s 
Early  Warning  and  Response  System  set  up  under  Decision  2119/98  and 
communicate  information  on  the  nature  and  scope  of  the  potential  threat  and  the 
measures to be taken. 

Commission and Member States 

Maintain close and effective collaboration with the producers of anti-viral and anti-
bacterial drugs as well as the vaccine manufacturing industry; 

Consider co-ordination of communications vis-à-vis media and public. 

21 

 
 
  
 
Phase 2, level 1 and 2: 

Commission 

Start  publishing,  via  the  Public  Heathe  website,  the  Early  Warning  and  Response 
system reports on pandemic Influenza cases in the affected regions. 

Member States 

Initiate  national  response  measures  according  to  pre-determined  national  pandemic 
plans. 

Obtain advice from the National Pandemic Planning Committee if new information 
has come to hand which necessitates amendments to the preparedness and response 
plan. 

Have specific pandemic surveillance plans in place to be able to provide information 
on  the  time  the  virus  was  introduced  in  their  territory,  on  the  severity  of  the 
pandemic  virus  and  on  the  capacity  of  health  systems  to  cope  with  challenges,  in 
accordance  with  Decision  2119/98/EC  and  Commission  Decision  2000/96/EC21  on 
the communicable diseases to be progressively covered by the Community network 
under Decision N° 2119/98/EC of the European Parliament and of the Council. 

Evaluate  provisional  data  on  regional  morbidity  and  mortality  and  carry  out  risk 
assessment. 

Circulate  samples  of  suspected  pandemic  strains  as  well  as  appropriate  rapid 
diagnosis reagents to the reference laboratories. 

Intensify production of reagents for diagnosis not following reference standards. 

Continue the validation of novel diagnostic tests. 

Identify appropriate near-patient tests for influenza and monitor use and results. 

Establish surveillance of clinical conditions which have been linked to novel virus. 

Assess validity of routinely collected clinical influenza indices. 

Intensify virological characterisation of influenza isolates. 

Implement  rapid  dissemination  of  information  gained  from  enhanced  clinical  and 
virological surveillance activities. 

Assess  new  medicines  and  if  necessary  undertake  batch  release  of  vaccines 
manufactured nationally. 

Take necessary steps to improve supply of vaccine against the new virus. 

Ensure that : 

21 

OJ L 28, 3.2.2000, p. 50 

22 

 
 
  
 
                                                 
– 

adequate measures are initiated, with a view to finalising decisions on priorities 
for the use of available vaccines and antiviral drugs. 

– 

priority groups are offered vaccination. 

Take  steps  to  ensure  that  the  health  services  have  access  to  sufficient  quantities  of 
medicines. 

Decide  on  measures  to  increase  the  treatment  capacity  in  the  municipal  health 
services and hospitals. 

Ensure that adequate and co-ordinated information is given to the health services and 
the general public about the development of the pandemic. 

Affected Member State(s) to inform the Member States and the Commission without 
delay,  via  the  Early  Warning  and  Response  System  of  the  nature  and  scope  of  the 
potential  threat,  the  measures  intended  to  be  taken  and  the  results  of  the  measures 
taken. 

Commission and Member States 

Activate, if appropriate, under the terms of Decision 2001/792/EC22 the Community 
mechanism  to  facilitate  reinforced  co-operation  in  civil  protection  assistance 
interventions  in  Member  States,  Acceding  and  EEA/EFTA  countries  or  countries 
outside the EU that might be affected. 

Commission to co-ordinate together with the Member States via the Early Warning 
and Response System, further measures to be taken at Community level, especially 
those concerning advice to travellers, occupationally exposed staff and other groups 
at risk, following the advice by the PRPG. 

22 

OJ L 297, 15.11.2002, p. 7 

23 

 
 
  
 
                                                 
Phase 2, levels 3 and 4: 

Commission 

Convene  the  PRPG,  activate  the  OAT  and  continue  using  the  Early  Warning  and 
Response System for information on and co-ordination of measures. 

Member States 

Continue the actions started in phase 2, levels 2 and 3. 

Develop  specific  reagents  and  ensure  that  laboratories  have  adequate  supplies  and 
Standard Operating Procedures for identification of new viruses. 

Monitor data on influenza activity across the country and in population subgroups. 

Investigate  and  document  outbreaks,  including  efficacy  of  any  appropriate  control 
measures. 

Implement  data  collection  for  studies  related  to  outcomes  of  influenza  in  identified 
risk groups. 

Review information on co-pathogens in influenza cases. 

Refine  antibiotic  and  symptomatic  treatment  guidelines  based  on  data  collected  as 
mentioned above. 

Produce  characterisation  of  all  influenza  novel  viruses  for  preparation  of  candidate 
vaccine strains. 

Compare virological data from national and international sources. 

Monitor  antiviral  susceptibility  of  virus  isolates  and  compare  data  with  other 
international sources. 

24 

 
 
  
 
Phase 3: 

Commission 

Continue actions started in phase 2, levels 3 and 4. 

Member States 

Continue the actions started in phase 2, levels 3 and 4. 

Collate and assess information on impact of pandemic on communities and hospitals. 

Reduce  active  surveillance  in  favour  of  detection  and  analysis  of  strains  from 
hospital cases. 

Concentrate on identification of antigenic drift in novel strains, antiviral resistance or 
emergence of other variants. 

Continue  surveillance  of  secondary  bacteriological  infections  to  help  develop 
antibiotic treatment policy. 

Liaise  with  distributors  of  vaccine,  if  vaccine  available,  for  monitoring  of  vaccine 
uptake. 

25 

 
 
  
 
Phase 4: 

Commission 

Continue the actions of phase 3. 

Evaluate experience gained and review the Community Plan, where necessary. 

Member States 

Continue the actions of phase 3. 

Review national preparedness and response plans, where necessary. 

Inform the other Member States and the Commission of the effects of the pandemic. 

Continue monitoring global spread and impact of virus. 

Estimate remaining need for vaccines and availability of antiviral drugs. 

Monitor any antigenic drift in the virus and its significance if detected. 

Commission and Member States 

Maintain the relevant measures as stipulated for phase 2, threat levels 3 and 4 with 
the revisions introduced during phase 3. 

26 

 
 
  
 
Phase 5: 

Member States 

Inform the other Member States and the Commission of the effects of the pandemic. 

Commission and Member States 

Assess the overall impact of the pandemic. 

Evaluate experience gained and review the Community and the national Plans, where 
necessary. 

6. 

CONCLUSIONS 

This  paper  outlines  the  key  elements  and  sets  of  actions  that  may  constitute  the 
components of the Community Influenza Pandemic Preparedness and Response Plan 
for discussion and conclusions on the appropriate follow-up. It is important that these 
elements  be  given  consideration  as  a  matter  of  urgency  and  that  they  fuel  the 
necessary  political  debate  and  help  steer  concrete  actions.  The  latter  can  take  the 
form  of  recommendations  or  binding  measures,  such  as  a  Commission  decision, 
within  the  context  of  the  existing  Community  legislative  framework  in  the  field  of 
public health.  

Furthermore,  as  set  out  in  the  recommendations  of  the  influenza  pandemic 
preparedness planning conference held in 2001, closer co-operation should be sought 
between  human  and  animal  health  authorities  and  experts  in  the  area  of  influenza 
virus  infections.  In  this  context,  a  mutual  exchange  of  experiences  in  contingency 
planning  could  be  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  would  present  a  formidable 
challenge  and  would  require  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. To this end, the Commission has proposed creating a European Centre for 
Disease  Prevention  and  Control  (ECDC),  which  can  provide  a  structured  and 
systematic  approach  to  the  surveillance  and  control  of  communicable  diseases  and 
other serious health threats that might affect the people of the European Union. The 
creation  of  a  European  Centre  would  mobilise  and  significantly  reinforce  the 
synergies  between  the  existing  national  centres  for  disease  control  and  would  no 
doubt help the Commission and the Member States to deal effectively with influenza. 
The  ECDC  would  be  expected  to  assume  all  tasks  related  to  the  epidemiological 
surveillance under the plan, to take part in the organisation and conduct of influenza 
outbreak assistance, and to provide advice on options and guidelines for appropriate 
responses  in  the  various  phases  and  levels  contained  in  the  plan  illustrated  in  this 
paper. 

27