Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions - Pandemic (H1N1) 2009 {SEC(2009) 1188} {SEC(2009) 1189} {SEC(2009) 1190} {SEC(2009) 1191} {SEC(2009) 1192}
Date: 2009-09-15
Institutions: European Commission
Subjects: EU action, action programme, disease prevention, epidemic, epidemiology, health policy, health risk, infectious disease, public health, vaccination

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 15.9.2009 
COM(2009) 481 final 

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

Pandemic (H1N1)2009 

{SEC(2009) 1188} 
{SEC(2009) 1189} 
{SEC(2009) 1190} 
{SEC(2009) 1191} 
{SEC(2009) 1192} 

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

Pandemic (H1N1)2009 

1. 

INTRODUCTION 

In April 2009, a novel strain of human influenza H1N1 was identified that had caused illness 
in Mexico and the United States first, in March and April 2009. 

On 11 June 2009, the World Health Organisation (WHO) declared a pandemic caused by the 
novel influenza A(H1N1) virus, called ‘pandemic (H1N1) 2009’. This declaration was in line 
with  the  WHO’s  global  influenza  preparedness  plan  where  phase  6,  the  pandemic  phase,  is 
defined as the virus causing sustained community-level outbreaks in at least two countries in 
one WHO region and in at least one other country in a different WHO region. The declaration 
therefore reflected the spread of the new virus, not the severity of illness caused by it. 

In  2005,  in  the  aftermath  of  the  A  (H5N1)  ‘bird  flu’  outbreaks,  the  Commission  adopted  a 
Communication on Pandemic Influenza Preparedness and Response Planning in the European 
Community,  which  set  out  the  objectives  for  each  inter-pandemic  and  pandemic  influenza 
phase and the action to be taken to achieve them at both national and Community levels1. This 
plan  has  provided  a  basis  for  the  preparedness  and  response  to  the  current  public  health 
situation.  

Today  the  European  Union  is  better  prepared  than  ever  before  to  tackle  cross-border  and 
global health threats in general and Pandemic (H1N1) 2009 in particular. Member States and 
the  Commission  have  legal  and  operational  provisions  in  place  to  authorise  pandemic 
vaccines and anti-viral medication after careful consideration of risks and benefits on the basis 
of  available  data  in  the  current  pandemic,  allowing  an  adequate  response  to  this  pandemic  
(H1N1) 2009  situation. 

Now  there  is  a  need  for  closer  coordination  across  sectors  and  Member  States,  whether  at 
Community,  national,  regional  or  local  levels,  to  help  to  mitigate  the  societal  impact  of  an 
influenza pandemic by means of appropriate preparedness and response planning within their 
individual remits. 

The main objective of this Communication is the protection of public health, by ensuring the 
best  possible  protection  of  citizens  against  the  current  pandemic.  To  this  aim,  the 
Communication presents in a single document the key issues on the public health coordination 
on pandemic (H1N1) 2009 at the EU level and internationally. In addition, it aims to highlight 
the  important  cross-sectoral  dimension  of  this  pandemic.  To  this  end,  and  in  response  to 
requests  by  the  Council  of  Health  Ministers,  the  Commission  is  also  making  available  in 
parallel  to  the  present  text,  five  separate  Commission  staff  working  documents  on  vaccine 
development,  vaccination  strategies,  joint  procurement,  communication  to  the  public  and 
support for third countries. 

1 

COM(2005) 607 of 28 November 2005. 

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2. 

COMPLEMENTARY ACTION TO EU MEMBER STATES 

Community action in the field of public health, as set out in Article 152 of the Treaty, must 
complement  national  policies  and  be  directed  towards  improving  public  health,  preventing 
human  illness  and  diseases  and  obviating  sources  of  danger  to  human  health.  The  aim  is  to 
tackle  the  major  health  scourges  by  promoting  research  into  their  causes,  their  transmission 
and their prevention and to provide health information and education.  

Community  action  in  the  field  of  public  health  must  fully  respect  the  responsibilities  of  the 
Member States for organising and delivering health services and medical care. In relation to 
the  international  collaboration  necessary  during  a  global  outbreak  such  as  this  pandemic, 
Article  152  states  that  the  Community  and  the  Member  States  will  foster  cooperation  with 
third countries and the competent international organisations in the sphere of public health2. 

A global pandemic is a cross-border health threat which affects not only public health but also 
society and economies within the EU. However, the technical capacity, budgetary resources 
and preparedness structures are not equivalent and equally available in every Member State. 

Consequently,  a  coordinated  and  supportive  EU-level  approach  to  public  health  measures 
between the EU Member States can provide substantial benefits. Firstly, Member States can 
draw on the scientific advice and guidance of the European Centre for Disease Prevention and 
Control, thereby ensuring that national resources for scientific assessments are allocated more 
efficiently. 

Secondly, coherent and agreed approaches between Member States authorities on issues such 
as  travel  advice  or  school  closures  contribute  to  a  better  public  understanding  and  trust  in 
public  health  measures.  Thirdly,  Europeans  demand  information  on  pandemic  situation  and 
how  to  protect  themselves.  Good,  objective,  up-to-date  communication  with  the  public  and 
the media means no mixed or wrong messages between countries. 

As a prophylaxis, vaccination is one of the most effective public health mitigation responses 
in a pandemic while for the treatment anti-viral medication remains a key option. Due to the 
limited global manufacturing capacity within a short time vaccines will only be available in 
the  EU  gradually.  In  addition,  solidarity  towards  the  third  countries  including  developing 
countries  is  also  an  issue  that  can  be  best  coordinated  at  the  European  level  between  the 
donors to ensure maximum benefits for the receiving countries addressed.  

Availability  of  vaccines  and  stockpiling  and  access  to  anti-viral  drugs  is  determined  at 
national  level  and  Member  States  have  taken  preparatory  action  in  this  respect.  To  support 
those Member States with fewer financial resources or adequate capacities, the Commission 
has  been  working  with  the  EU  Health  Security  Committee  to  explore  ways  to  support 
Member States for procurement of vaccines. 

3. 

BACKGROUND 

On 30 April 2009, the Ministers of Health adopted Council conclusions on influenza A/H1N1 
infection3.  They  highlighted  the  need  to  coordinate  national  measures  in  Europe  and  called 
upon  the Commission to  continue to facilitate information sharing and cooperation between 
the  Member  States,  in  particular  on  risk  evaluation,  risk  management  and  medical 
countermeasures.  

2 
3 

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12002E152:EN:HTML 
http://ec.europa.eu/health-eu/doc/council_concl.pdf 

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These coordination functions should be carried out in the Health Security Committee (HSC), 
the  Early  Warning  and  Response  System  for  Communicable  Diseases  (EWRS)  and  the 
Committee  of 
the  Epidemiological  Surveillance  and  Control  of 
Communicable  Diseases  as  well  as  with  third  countries  and  international  organisations,  in 
particular the WHO. The Commission has chaired joint meetings of Member States’ EWRS 
national authorities and the HSC regularly since the beginning of the outbreak. 

the  Network  for 

On 8 and 9 June the Council discussed vaccines and vaccination strategies against Pandemic 
(H1N1) 2009 and gave the HSC a mandate to work on these two issues. The Health Ministers 
met again informally on 6 and 7 July 2009 to discuss preparedness and response to Pandemic 
(H1N1)  2009,  focusing  on  a  Commission  information  note  on  vaccination  policy  and  the 
outcome of the meeting of technical experts organised by the Swedish Presidency on 4 and 5 
July 2009.  

At international level, the Commission is a member of the Global Health Security Initiative on 
pandemic  influenza  and  other  health  security-related  issues  bringing  together  G7  countries 
and  Mexico.  This  network  has  been  useful  for  sharing  information  between  members  on 
public health measures planned or taken.  

The  Global  Health  Security  Initiative  held  informal  meetings  twice,  first  during  the  World 
Health  Assembly  in  May  and  then,  at  the  invitation  of  Mexico,  in  Cancun  at  a  ministerial 
meeting  on  2  and  3  July  2009  on  Pandemic  (H1N1)  2009.  Another  meeting  was  held  in 
September in Brussels upon the invitation of the Commission.  

4. 

EU  COORDINATION  ON  PUBLIC  HEALTH  RESPONSE  –  JOINING  FORCES  WITH 
MEMBER STATES 

The  Commission  monitors  the  situation  internally  and  externally  through  various  networks, 
expert  groups  and  fora  by  which  it  enables  exchange  of  information  with  MS  and 
international  organisations.  The  internal  crisis  management  mechanism  of  the  Commission 
(ARGUS) has been activated, enabling all affected services to jointly assess the multi-sectoral 
dimensions of this pandemic and respond accordingly.  

In  the  health  sector,  the  Commission  cooperates  closely  with  the  scientific  assessment 
agencies  –  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC),  the  European 
Medicines  Agency  (EMEA)  and  the  European  Food  Safety  Authority  (EFSA)  –  on  specific 
issues  and  liaises  closely  with  the  WHO  to  ensure  that  measures  taken  at  European  Union 
level are in line with the WHO recommendations and international health regulations.  

In order to ensure an effective, horizontal public health response to the pandemic at European 
level,  as  outlined  in  the  Commission  Communication  on  Pandemic  Influenza  Preparedness 
and  Response  Planning,  the  European  Union  has  already  taken  a  number  of  key  measures 
using existing legal and public health mechanisms4: 
•  The common case definition, adopted in a Commission decision on 1 May 20095; 

•  Agreement on advice to persons planning to travel to or returning from affected areas on 

18 May 2009;  

•  Extension of the surveillance system to identify new cases in the EU on 18 May 2009;  

4 

5 

These  documents  can  be  found  on  the  Commission’s  dedicated  website  on  Pandemic  (H1N1)  2009:  
http://ec.europa.eu/health/ph_threats/com/Influenza/novelflu_en.htm. 
OJ L 110, 1.5.2009, p. 58. 

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•  Guidelines on case management and treatments and advice on medical countermeasures for 

health professionals on 18 May 2009; 

•  Advice for the general public on personal protective measures agreed and made available 

to Member States in all the official EU languages on 4 May 2009;  

•  Statements by the Health Security Committee and the Early Warning and Response System 

(EWRS) contact points on school closures and travel advice on 13 August 2009; 

•  Statement  on  ‘Vaccination  strategies:  target  and  priority  groups’  agreed  by  the  Health 

Security Committee and the EWRS contact points on 25 August 2009.  

Decision 2119/98/EC6 places an obligation on Member States to report influenza outbreaks to 
the  Community  network  on  communicable  diseases.  They  must  give  prompt  notification  of 
cases  and  then  the  Commission  will  transmit  the  information  immediately  to  all  the  other 
Member States, prior to, where possible consultation and coordination of countermeasures by 
the Member States. The ECDC collects this information. In the case of pandemic influenza, 
daily situation reports are prepared for the Member States. ECDC is also providing ongoing 
support to Member States and the Commission in terms of surveillance and response to the 
crisis.  This  includes  advice  to  the  public  on  personal  protective  measures,  and  to  Member 
States  on  mitigation  activities7.The  Community  Civil  Protection  Mechanism  is  available  to 
facilitate  mutual  assistance  between  Member  States  if  national  response  capacities  become 
overwhelmed.  This  may  include  immediate  civil  protection  and  medical  assistance.  Third 
countries can also appeal for assistance through this mechanism 

As regards the authorisation of the necessary medicinal products, Community legislation sets 
out instruments which are well prepared for a pandemic through: 

•  Specific  regulatory  provisions  for  a  fast-track  scientific  assessment  and  subsequent 
authorisation for marketing of human influenza vaccines and key medicinal products, such 
as anti-viral medication, in a pandemic situation. 

•  Specific  regulatory  provisions  which  allow  Member  States  to  take  national  decisions  to 

authorise the distribution of unauthorised vaccines in an Influenza pandemic. 

to  a  Community  authorisation 

European  Medicines  Agency  (EMEA)  provides  scientific  opinions  on  the  risk-benefit 
evaluation  of  those  medicinal  products,  including  vaccines  and  anti-viral  medication,  which 
through  Commission  Decision  (central 
are  subject 
authorisation). In addition, through technical assistance, EMEA supports the network of the 
Member  States on scientific discussions in preparation of national marketing authorisations 
of  medicinal  products.  In  the  preparation  of  a  scientific  assessment  of  Influenza  A  (H1N1) 
2009 vaccines the EMEA is exchanging views with registration authorities in third countries, 
such as in the US. 

While  various  anti-viral  medicines  received  approval  for  marketing  in  the  past  and  are 
available  for  treatment  of  pandemic  influenza  in  the  EU,  new  measures  have  been 
concentrated  on  an  accelerated  assessment  of  applications  for  marketing  authorisations  of 
pandemic Influenza A(H1N1) vaccines. Both the EMEA and Member States have received or 
are expecting such applications.  

At  Community  level,  the  EMEA  is  currently  evaluating  data  and  applications  for  several 
vaccines. As soon as the EMEA provides a positive scientific opinion on each vaccine based 

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OJ L 268, 3.10.1998, p. 1. 
http://www.ecdc.europa.eu/en/healthtopics/Pages/Influenza_A(H1N1)_Outbreak.aspx 

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on a detailed assessment of risks and benefits, the Commission will ensure a swift decision on 
an  authorisation.  After  authorisation,  specific  pharmacovigilance  monitoring  is  intended  to 
allow  an  ongoing  assessment  of  the  safety  and  efficacy  of  these  medicines.  In  the  case  of 
national  authorisations,  it  is  up  to  Member  States  to  decide  on  any  acceleration  of  the 
scientific assessment and regulatory procedure. 

Human- animal interface 

The Commission has also taken action on an additional issue concerning possible infection of 
pigs with the Pandemic (H1N1) 2009 influenza virus in Europe. This event has already been 
reported  in  Canada,  Argentina  and  Australia,  probably  due  to  previous  human-to-pig 
transmission. Although in those countries pigs have played no role as an additional source of 
the virus for humans so far, any possible detection and spread of the pandemic virus amongst 
pigs in Europe could raise unjustified fears amongst the public.  

On 14 July 2009, the Standing Committee on the Food Chain and Animal Health endorsed a 
guidance document drafted by the Commission on surveillance and control measures for the 
pandemic  virus  in  pigs8,  in  order  to  ensure  that  farmers  and  veterinary  and  public  health 
authorities  are  prepared  for  any  such  event  and  thereby  reduce  the  risk  of  unjustified  panic 
amongst  the  public.  In  addition,  recently  the  Pandemic  (H1N1)  2009  virus  was  detected  in 
turkeys in Chile most likely due to virus transmission from infected humans. The Commission 
will monitor these developments. 

Aviation  

Regarding air transport a specific meeting with the Civil Aviation Authorities was organised 
on  5  May  2009.  As  a  conclusion,  it  was  agreed  to  activate  the  network  of  national  contact 
points  for  health  issues,  which  allows  to  exchange  and  share  relevant  information  on  all  air 
transport issues linked to the Pandemic (H1N1) 2009 between EU Member States.  

A  key  question  in  contingency  planning  for  a  possible  influenza  pandemic  is  the  value  of 
restricting international travel to and from affected countries or regions, or imposing entry or 
exit screening of passengers at airports. The potential for infectious diseases to spread rapidly 
through an increasingly well-connected, steadily growing world population was brought into 
sharp  focus  during  the  2003  epidemic  of  severe  acute  respiratory  syndrome  (SARS). 
Nevertheless, as it appeared then, the measures on travel restrictions were targeting specific 
countries in which the epidemic had spread a lot and have a limited effect. Moreover, H1N1 
pandemic  current  situation  appears  to  be  very  different  as  it  has  already  spread  all  over  the 
world. Thus, according to WHO recommendations, travel restrictions were not considered as 
an  appropriate  tool  in  the  present  situation.  Such  position  was  also  sent  to  all  aviation 
authorities  by  International  Civil  Aviation  Organization  (ICAO)  on  1  May  and  confirmed 
during  ICAO's  Council  meeting  on  11  May  2009.  In  line  with  this  position,  no 
recommendation on travel restriction, including air transport, has been taken at EU level.  

Moreover, it was also agreed that according to the evolution of the situation, and taking into 
account  the  advice  of  the  relevant  health  authorities,  Member  States  should  take  all 
appropriate measures in the air transport sector. Such measures should be proportionate, non-
discriminatory and strictly limited to meet the health risks. In any event, EU coordination of 
national measures shall continue to be ensured.  

8 

The guidance document is available on the web at: 

http://ec.europa.eu/food/animal/diseases/influenzaAH1N1/docs/wd_surveillance_and_control_of_h1n1
_in_pigs_rev1_140709_en.pdf. 

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Financial assistance possibilities at EU level  

The European Union Solidarity Fund may be called upon by Member States and countries in 
process  of  negotiating  their  accession  to  the  EU9  in  case  of  major  natural  disasters  for  the 
reimbursement  of  certain  costs  to  repair  damage.  Public  health  crises  and  in  particular 
expenditure for buying vaccines do not fall within the scope of the Solidarity Fund. 

It  should  be  noted  that  a  Commission  initiative  to  enlarge  the  scope  of  the  fund  to  include, 
among  other  elements,  action  in  the  event  of  public  health  crises  is  pending  before  the 
Council  without  any  progress  since  2005  (EC  proposal  COM(2005)108)10,  it  would  be 
important  to  reflect  how  to  move  forward  on  this  particular  issue.  Other  structural  funds 
prioritise health investments in infrastructure, hence are less viable in urgent situations.  

The accompanying Commission Staff Working Document "Support to third countries to fight 
Pandemic  (H1N1)  2009"  addresses  the  international  dimension  of  the  EU  response.  Should 
assistance  be  requested  by  third  countries,  the  EU  could  respond  as  appropriate  through  its 
programmes and instruments, including through humanitarian aid. 

As far as the Commission is concerned, this financial assistance is expected to be covered by 
existing  financial  instruments.  If  additional  important  needs  rise,  the  Commission  will 
examine possible available ways of facing these needs 

Seventh Framework Programme for Research (FP7) 

The Framework Programmes for Research (FP7 and its predecessors FP6 and FP5 have made 
significant  contributions  to  public  health-related  research  into  influenza  and  to  better 
preparedness for pandemics. Innovative vaccination technologies and adjuvants, surveillance 
studies  on  birds  and  pigs,  development  of  point-of-care  diagnostic  tools  and  new  antiviral 
drugs  have  all  been  financed  by  projects  under  the  FPs.  In  particular,  two  ongoing  FP7 
projects are directly relevant to the current pandemic11. 

5. 

INTERNATIONAL COORDINATION 

Since  the  first  reports  on  the  outbreak  of  (H1N1)  influenza,  the  European  Commission  has 
been  stressing  the  importance  of  exchanging  information  and  coordinating  measures  at 
international level. The Commission supports the leading role of the WHO in monitoring the 
pandemic  under  the  International  Health  Regulations,  preparing  recommendations  and 
evidence-based guidance, and facilitating support to the poorest countries including providing 
expertise, supporting capacity building and even procurement of vaccines and antivirals.  

As  mentioned  earlier,  the  Commission  has  been  also  coordinating  with  the  Global  Health 
Security  Initiative  (GHSI)  on  public  health  action  and,  particularly,  exchanging  information 
on public health measures.  

The  GHSI  network  is  working  on  issues  similar  to  those  identified  in  the  EU  context  and 
striving to ensure that they are addressed in a coordinated way across the GHSI countries. The 
Commission hosted an extraordinary ministerial meeting of the GHSI on 11 September 2009 
on issues of common interest related  to preparedness for and response  to pandemic (H1N1) 

9 
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11 

Currently these include only Turkey and Croatia 
COM(2005) 108 of 6 April 2005 
EMPERIE  is  contributing  directly  to  research  into  important  biological  aspects  (see  http://ec.europa.eu/research/health/infectious-diseases/emerging-

epidemics/projects/139_en.html FLUMODCONT to public health aspects (http://www.flumodcont.eu/index.php/home). 

For 

a 

full 

overview 

of 

all 

projects 

please 

see 

http://ec.europa.eu/research/health/infectious-diseases/emerging-epidemics/projects_en.html  

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2009. Mindful of the potential for a more virulent wave of the (H1N1) 2009 influenza virus in 
the months ahead, the meeting addressed a range of issues critical for an effective response.  

During  the  14th  ministerial  meeting  of  the  European  Union  and  the  Rio  Group  (all  Latin 
American  countries,  the  Dominican  Republic,  Jamaica,  Belize,  Guyana  and  Haiti),  held  in 
Prague on 13 May 2009, a Joint Declaration on the ‘Novel Flu Virus’ was adopted. It called 
for enhancing the ongoing coordination of measures between all competent organisations and 
bodies. 

For  the  preparation  of  strategies  for  the  assessment  and  authorisation  of  vaccines  the 
European Commission, the ECDC and the EMEA are in close contact with the WHO and via 
the WHO also with other regulatory authorities worldwide. Furthermore, the Commission and 
the EMEA concluded bilateral confidentiality arrangements with regulatory agencies of three 
third countries for the regulatory and scientific collaboration (US, Canada, Japan) which has 
been experienced a useful mechanism for information exchange in the current pandemic. 

6. 

SOCIAL AND ECONOMIC EFFECTS OF THE PANDEMIC 

The  World  Bank  estimates  that  the  measures  put  in  place  to  slow  down  the  spread  of  a 
pandemic,  although  appropriate,  could  have  a  great  economic  impact.  They  are  said  to 
account  for  60 %  of  the  total  costs.  Only  12 %  would  be  linked  to  mortality  and  28 %  to 
absenteeism and illness. Experience has shown that the economic impact of a health crisis is 
rarely directly correlated to the medical severity of the virus. 

The  immediate  impact  is  likely  to  attract  the  most  public  attention.  However,  depending  on 
the  duration  and  severity  of  the  pandemic,  the  long-term  effect  can  significantly  exceed  the 
short-term costs. 

Immediate effects (epidemiological uncertainty) 

The  most  immediate  economic  impact  of  a  pandemic  might  arise  not  from  actual  death  or 
sickness but from uncoordinated efforts by individuals to avoid becoming infected. 

It is anticipated that there could be growing demand for hospitalization and medical treatment, 
as well as for medicines, including antivirals and vaccines, masks, gloves, antimicrobials and 
other counter measures. However, limited spare capacity of some service providers could lead 
to  a  situation  when  other  health  services  could  be  crowded  out  by  those  which  are 
pandemic-related. 

Apart  from  healthcare-related  developments,  people  are  expected  to  take  additional 
precautions and to minimise face-to-face interactions in order to avoid infection. In the worst 
case  scenario,  this  could  trigger  a  decline  in  demand  in  some  economic  and  cross-border 
mobility of people and goods could be hampered. 

For the labour market, the main cost is linked to the increased morbidity. This would lead to 
absenteeism from work, disruption of production processes, shifts to more costly procedures 
and, eventually, lower productivity. If the psychological impact of the pandemic is especially 
severe, absenteeism amongst otherwise healthy workers can also be expected.  

The Health Council in its Conclusions of 16 December 2008 asked the Commission to take 
into  account  the  inter-sectoral  dimension  of  preparing  for  pandemic  influenza  by  reviewing 
the  arrangements  covering  this  area  and  by  updating  the  Communication  from  the 
Commission to the Council and the European Parliament of 28 November 2005 on Pandemic 
Influenza Preparedness Planning.  

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The  Commission  is  reflecting  on  possible  on  strengthening  of  inter-  and  multi-sectoral 
collaboration, to help mitigate the more general effects of the current pandemic and possible 
future pandemics. 

Long-term effects (economic uncertainty) 

The costs related to economic uncertainties associated with pandemics, especially in times of 
current  economic  hardship,  can  slow  down  fragile  economic  recovery.  For  developing 
countries, the WHO has stressed that all means available will be used to avoid inequities and 
give developing countries access to vaccines. This would make sure that developing countries 
do  not  suffer  disproportionately.  A  strong  health  system  is  also  necessary.  This  is  why  the 
WHO has called for solidarity to target such structural weaknesses too. On 20 May 2009, the 
WHO  issued  a  report  which  stated  that  72  countries  had  been  provided  with  antiviral 
medicines. 

The World Bank supports solidarity with countries that need help to respond efficiently to the 
pandemic and its effects. Therefore, on 2 June the World Bank approved ‘fast-track’ status for 
$500  million  to  help  countries  finance  operations  to  prevent  and  control  outbreaks  of 
pandemic (H1N1) 2009. 

Effects on global, regional or national security 

The  diffusion  of  the  pandemic  (H1N1)  2009  may  have  important  implications  on  global 
regional and national security, stability and governance. In this respect an EU external policy 
aimed at strengthening “early warning” capacity in third countries should be seen as a major 
component of the overall EU Security Strategy and a major EU contribution to better world 
stability and governance.  

7. 

KEY STRATEGIC STRANDS

12 

Joint procurement of vaccines 

During  the  informal  Health  Council  on  6  July  and  based  on  a  broad  consensus  on  pursuing 
joint procurement of vaccine against the pandemic (H1N1) 2009 influenza virus, in particular 
for  Member  States  which  had  not  yet  placed  orders,  the  Swedish  Presidency  asked  the 
Commission to set up a mechanism to help with joint procurement of vaccines for interested 
Member States.  

Given  the  stage  of  development  of  the  pandemic,  and  the  advance  purchase  orders  already 
concluded by several member states, it is not considered reasonable or efficient at this stage to 
launch  a  joint  procurement  procedure  at  EU  level  between  interested  Member  States  for 
vaccine procurement. 

The  aim  should  rather  be  to  launch  a  bundle  of  national  calls  for  tender  by  the  interested 
Member  States  to  be  carried  out  simultaneously  or  as  a  whole.  At  first  sight,  taking  into 
account the time pressure (vaccines to be bought in October) this option seems to be the most 
workable (all contractual documents in place, no issue of conflict of laws) and it could have 
the  most  significant  impact  in  ensuring  availability  of  supply  of  vaccines  for  target  and 
priority groups in the timeframe available.  

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Five  technical  documents  have  been  prepared  in  parallel  to  this  Communication  to  set  out  the  key 
strategic  areas.  These  documents  provide  an  overview  of  the  range  of  potential  actions  that  can  be 
useful in supporting Member States efforts in responding to the pandemic. 

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The Commission will support the Member States in their joint procurement efforts and will 
organise  necessary  coordination  meetings.  The  Commission  is  ready  to  act  as  facilitator  in 
order  to  provide  advice  on  the  EU  legal  basis  where  necessary  and  support  mutual 
information exchange between  Member States having already advance purchase agreements 
and  those  having  not  yet  concluded  such  agreements.  For  the  mid  and  long  term  the 
Commission will continue exploring alternative procedures. 

The  Commission  also  encourages,  in  parallel  to  the  joint  procurement  initiative,  a  common 
approach to cross-border sharing and voluntary sale within the EU. A mechanism to envisage 
cooperation between Member States in order to address shortages of vaccine in one Member 
State and high supplies in another country could be envisaged and might be coordinated at EU 
level.  On  the  basis  of  the  replies  received  so  far  by  the  Commission,  some  Member  States 
have already included in the contracts that vaccines, which are not used, can be sold to other 
countries.  

Support to third countries to fight Pandemic (H1N1) 2009 

The key specific objective of the staff working document on support to third countries is to 
identify  areas  and  existing  EU  mechanisms  by  which  the  needs  of  third  countries  could  be 
supported  with  the  aim  of  steadily  increasing  their  level  of  protection  in  the  face  of  the 
pandemic  (H1N1)  2009,  while  respecting  the  principles  of  country  ownership  and  aid 
effectiveness.  All  donor  support  to  the  health  sector  in  developing  countries  has  to  respect 
country  leadership  in  strategy  design  and  ownership  of  the  implementation  process,  as 
internationally  agreed  in  2008  in  the  Accra  Agenda  for  Action,  in  order  to  make  the 
international  aid  effort  more  effective.  It  is  important  to  ensure  that  initiation  and  concrete 
help for third countries is carried out in close cooperation with the WHO and, where relevant, 
with  Non-Governmental  Organisations  (NGOs).  A  gradual  increase  of  cooperation  between 
ECDC  and  certain  third  countries,  in  particular  those  falling  under  the  European 
Neighbourhood Policy, would also help in fighting the pandemic. 

The Commission has strongly contributed to global influenza preparedness through its leading 
role in the global response against Avian Influenza going largely beyond the sole challenge of 
Avian  Influenza,  focusing  on  the  sustainable  reinforcement  of  health  systems  and  including 
general pandemic preparedness. Furthermore, the European Commission is providing funding 
to a number of low income countries through a range of bilateral measures (projects, health 
sector budget support, general budget support and regional programmes), so that their national 
health systems can respond more adequately to the challenge of Pandemic (H1N1) 2009. 

The  Commission  will  address  the  following  specific  objectives:  to  closely  monitor  the 
situation in third countries, through regular relations with UNSIC, WHO, EU Member states 
and with other stakeholders, so as to be in a position to confirm in time a potential threat from 
the  pandemic  (H1N1)  2009; to  identify  the  actual  needs  of  the  countries,  for  strengthening 
their preparedness and prevention capacities, but also for coping with acute outbreaks if and 
when they occur; to conduct EU vaccine procurement in a way so as not to impede access by 
developing  countries  to  vaccine  and  other  medical  goods  and  to  promote  increased  access 
taking  into  account  limited  resources.  In  line  with  the  WHO  Director-General's  call  for 
international  solidarity  to  provide  fair  and  equitable  access  for  all  countries  to  pandemic 
vaccine when it becomes available, the possibility to reserve for developing countries a share 
of vaccines ordered by Member States should be seriously considered. 

Vaccination strategies 

Recognising  that  the  responsibility  for  developing  a  vaccination  strategy  against  pandemic 
(H1N1)  2009  lies  with  the  Member  States,  the  Commission  Staff  Working  Document  on 

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vaccination strategies based on the current scientific evidence and epidemiological trends sets 
out possible options that Member States might take into account when determining strategies 
fitting  the  specific  conditions  prevailing  on  their  territories  Indeed,  based  on  the  broad 
orientations  provided  for  by  the  Commission  Staff  Working  Document  Member  States  can 
develop  different  vaccination  schemes,  taking  into  account  epidemiological  trends,  health 
service  structures  and  available  resources.  The  statement  on  target  and  priority  groups  for 
vaccination against pandemic (H1N1) 2009 influenza, agreed by the European Union Health 
Security Committee on 26 August 2009, provided basis for this document13. 

The initial limited availability of vaccines, together with the potential need for a large-scale 
vaccination  campaign,  poses  challenges  to  healthcare  systems  and  highlights  the  need  for  a 
carefully  planned  vaccination  strategy,  taking  into  account  the  need  to  protect  vulnerable 
people, to limit the spread of infection and to maintain essential services in the society. Public 
confidence, and therefore the success of any vaccination campaign against pandemic (H1N1) 
2009, will depend on active and transparent communication on the benefits and the risks of 
vaccination against pandemic (H1N1) 2009. 

Indeed it is important to consider that there is a common interest for each national vaccination 
scheme  to  be  efficient  in  order  to  curb  the  spread  of  the  virus  and  to  eliminate  any  "virus 
reservoir" to prevent further successive reactivations of the pandemic. 

Regulatory process for the authorisation of antiviral medicines and vaccines 

The  EU  has  prepared  itself  early  for  a  pandemic  through  establishing  provisions  for  an 
accelerated  assessment,  such  as  the  assessment  of  new  applications  for  marketing 
authorisations of pandemic Influenza A (H1N1) vaccines and variations thereof. 

The  Commission  Staff  working  document  provides  a  comprehensive  overview  on  the  key 
steps  and  aspects  related  to  the  authorisation  of  anti-viral  medicines  and  vaccines.  Specific 
consideration is given to a description of tailor-made provisions for a fast-track authorisation 
in a pandemic situation and subsequent pharmacovigilance obligations.  

Communication to the public and media on Pandemic (H1N1) 2009 

To  achieve  an  adequate  uptake  of  vaccines  among  risk  groups  and  to  deal  efficiently  with 
other  prevention  and  vaccination-related  problems,  public  health  authorities  across  Europe 
will face challenges necessitating a carefully planned communication strategy. 

The Staff Working Document on Information to the Public outlines the main issues relating to 
coordinated  communication  with  the  public  on  pandemic  (H1N1)  2009  with  a  view  to 
delivering  targeted  and  scientifically  validated  messages  for  the  general  public  and  for 
specific  risk  groups. The document  identifies possible joint action between the EU Member 
States  and  the  Commission  to  develop  a  coherent  European  strategy  on  information  and 
communication. 

8. 

CONCLUSIONS 

Pandemic (H1N1) 2009 is a global challenge. In the Commission’s view, the EU coordination 
has  worked  well  so  far.  This  crisis  has  shown  that  efficient  channels  for  exchanging 
information are in place to support good cooperation and coordination of efforts at European 
level.  The  international  work  and  collaboration  can  also  be  built  on  to  tackle  health  threats 
effectively. The benefits are that they ensure coherence and maximise the effectiveness of the 

13 

http://ec.europa.eu/health/ph_threats/com/Influenza/novelflu_en.htm. 

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national  public  health  response.  The  Commission  will  continue  to  work  toward  supporting 
national  health  authorities  to  review  their  preparedness  regimes  and  their  response  to  the 
pandemic as appropriate. 

Inter-sectoral  action  will  remain  a  key  component  in  tackling  pandemic  (H1N1)  2009.  An 
important  dimension  of  responses  to  a  pandemic  at  any  level  is  that  they  must  be  multi-
sectoral,  encompassing  services  outside  the  health  sector.  More  needs  to  be  done  and  the 
Commission will consider with Member States the need for measures to strengthen inter and 
multi-sectoral collaboration to ensure business continuity and minimise the disruption of the 
negative impact of the pandemic. 

Depending on the scale and severity of the public health situation, business continuity plans 
could also identify measures and arrangements to keep critical services working. Establishing 
continuity plans in relevant areas will be useful to prevent any avoidable, negative economic 
impact of the influenza pandemic.  

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