Commission staff working document on support to third countries to fight the Influenza A(H1N1) accompanying the 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 {COM(2009) 481} {SEC(2009) 1188} {SEC(2009) 1189} {SEC(2009) 1190} {SEC(2009) 1191}
Date: 2009-09-15
Institutions: European Commission
Subjects: aid system, disease prevention, epidemiology, health control, health risk, infectious disease, public health, third country

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 15.9.2009 
SEC(2009) 1192 final 

COMMISSION STAFF WORKING DOCUMENT 

on support to third countries to fight the Influenza A(H1N1)  

accompanying the 

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 

{COM(2009) 481} 
{SEC(2009) 1188} 
{SEC(2009) 1189} 
{SEC(2009) 1190} 
{SEC(2009) 1191} 

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1. 

INTRODUCTION  

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

On 11 June 2009, the World Health Organisation (WHO) officially declared a pandemic, due 
to  the  novel  influenza  A(H1N1)  virus,  hereafter  called  'pandemic  influenza  (H1N1)  2009'. 
This  declaration  was  in  full  conformity  with  the  WHO  global  influenza  preparedness  plan 
where  phase  6,  the  pandemic  phase,  is  characterized  by  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  was  a  reflection  of  the 
spread of the new virus, not the severity of illness caused by it.  

This  recognition  of  pandemic  (H1N1)  2009  implies  that  all  countries  could  or  would  be 
affected  and  that  a  globally  concerted  response  is  required  to  monitor  and  control  the 
situation. As EU Member States have announced that they are developing extensive plans and 
are  committing  significant  funds  to  strengthen  their  capacities  to  prevent  and/or  to  mitigate 
the effects of the pandemic within Europe, the EU cannot ignore the potential consequences 
for the  populations of third countries, in particular developing countries. This is an issue of 
solidarity and of efficiency in the face of a global crisis. 

The current document results from an informal Council of health ministers on 6-7 July where 
the Commission was requested to continue to prepare for the ongoing pandemic in view of the 
expected second wave in autumn in the northern hemisphere. In addition to other documents 
dealing  with  EU  internal  issues  related  to  pandemic  (H1N1)  2009  response,  such  as  public 
information, epidemiological surveillance, and a joint mechanism to facilitate procurement of 
vaccines  and  antivirals,  the  Council  asked  for  a  special  paper  on  EU  support  to  third 
countries.  

At this current stage of the H1N1 pandemic, we know very little about its actual impact on 
developing countries, and on its potential development in the short and medium term. Despite 
recent  improvements  in  local  authorities'  awareness,  surveillance  systems  and  laboratory 
capacities  (mainly  as  a  result  of  the  global  response  to  the  Avian  Influenza  threat)  reliable 
data is lacking and the limited number of reported cases and related deaths does not provide 
sufficient evidence.  

Within the framework of the International Health Regulations (IHR), which came into force 
in 2008, the international community has mandated the World Health Organisation (WHO) to 
monitor and analyse the overall situation and, on the basis of the best available evidence, to 
make proposals for appropriate control measures, as well as ensuring the proper coordination 
of international support to the most needy countries.  

The  European  Commission  has  been  actively  supporting  the  global  response  to  Avian 
Influenza politically, technically and financially by setting up of and contributing to a World 
Bank  (WB)  trust  fund  for  example.  .The  Commission  has  also  developed  good  working 
relations  with  the  UN  senior  influenza  coordination  (UNSIC)  and  with  international 
organisations such as WHO, World Organisation for Animal Health OIE and WB and built a 
pool  of  EC/EU  internal  expertise  and  a  forum  for  exchanging  information  that  could  be 
widened to cope with this new pandemic. 

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2. 

PURPOSE AND OBJECTIVES  

The  key  specific  objective  of  the  current  document  is  to  identify  areas  and  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 influenza (H1N1) 2009, while respecting the 
principles of country ownership and aid effectiveness. 

In particular, the European Commission should address the following specific objectives 

•  To  closely  monitor  the  situation  in  third  countries,  through  regular  relations  with  the 
European Centre for Disease Prevention and Control, UNSIC, WHO, EU Member States, 
partner  countries,  and  with  other  stakeholders,  to  be  in  a  position  to  address  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. 

3. 

LEGAL ASPECTS 

According to the objectives of the Community action in the field of public health as set out in 
Article  152  of  the  Treaty,  the  Community  and  the  Member  States  shall  foster  cooperation 
with  third  countries  and  the  competent  international  organisations  in  the  sphere  of  public 
health.  Community  action  shall  complement  national  policies,  shall  be  directed  towards 
improving  public  health,  preventing  human  illness  and  diseases,  and  obviating  sources  of 
danger to human health. Such action shall cover the fight against the major health scourges by 
promoting research into their causes, their transmission and their prevention, as well as health 
information and education.  

On  the  other  hand,  based  on  Article  177  to  181  of  the  Treaty,  and  according  to  the  EU 
Consensus for Development adopted by the European Union in 2006, the Union commits to 
the  principles  of  ownership  of  development  strategies  by  partner  countries,  and  of  shared 
responsibility and accountability between EU and developing countries for their joint efforts. 
In the Consensus, the EU commits itself to provide more and better aid, and to take action to 
advance  policy  coherence  for  development.  These  commitments  have  been  confirmed  more 
recently in the Accra Agenda for action on aid effectiveness adopted in September 2008.  

4. 

SITUATION AND NEEDS OF THIRD COUNTRIES  

4.1. 

Developing Countries 

From a scientific point of view we now understand a great deal about the transmission and the 
severity of pandemic influenza (H1N1) 2009 in the richer parts of the globe. This is not the 
case for developing countries where reliable data is almost completely lacking and where our 
understanding of the potential impact of the virus is extremely limited. For example, as of the 
18th of August, less than 3200 lab-confirmed cases, and 11 deaths had been reported in Africa 
since the onset of the pandemic, while in the EU/EFTA 40156 cases and 63 deaths had been 
notified (situation as at 19 August 2009). This difference in reported cases probably reflects 
more  the  capacity  of  diagnosing  and  reporting  the  disease  than  actual  differences  in 
occurrence. 

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Developing  countries  already  suffer  from  a  high  disease  burden  from  many  endemic 
infectious diseases. Their capacity to monitor, prevent and react in the case of acute outbreaks 
of more common infectious diseases (such as meningitis or cholera) is very limited. They are 
obliged to run their health systems with considerably lower levels of funding than the richer 
nations. Developing countries will inevitably face difficult choices as to how to put their very 
limited  resources  to  their  optimal  use.  The  international  community  must  therefore  offer  its 
support in these situations.  

It must be remembered that developing countries are particularly vulnerable to the impact of 
the  present  world  financial  and  economic  crisis.  With  fiscal  space  under  pressure,  p  public 
social  spending,  in  particular  services  in  the  fields  of  education  and  health,  is  increasingly 
liable  to  be  cut,  with  evident  Millennium  Development  Goal  fallouts..  In  the  context  of  the 
international response to the global financial crisis and in line with commitments undertaken 
at the G20 London Summit of 2 April 2009, the European Commission has set up an ad hoc 
mechanism, the Vulnerability FLEX, which is expected to play a role in preserving the level 
of public social service provision.  

Nevertheless,  the  social  impact  of  the  pandemic  influenza  (H1N1)  2009  serves  as  a  strong 
reminder  that  we  are  still  very  far  from  being  able  to  guarantee  equal  access  to  even  basic 
health  care,  and  that  vastly  increased  efforts  are  needed  if  we  are  to  meet  this  goal.  Of 
additional concern is the issue of availability and affordability of vaccines against pandemic 
influenza (H1N1) 2009 in developing countries. At the most basic level there are no agreed 
protocols  concerning  who  to  vaccinate  and  when  vaccination  should  be  carried  out.  It  is 
essential that WHO, which is the lead negotiator with manufacturers on vaccine production, 
pricing  and  procurement,  should  provide  adequate  details  of  current  global  production 
capacity and on the potential global needs for vaccine supplies.  

Other third countries 

4.2. 
Candidates and potential candidates1 

In  the  context  of  the  enlargement  policy,  the  Commission  helps  legal  alignment  with  the 
acquis in the area of public health in the candidates and potential candidates, and supports and 
monitors the implementation and effective enforcement of national legislation through various 
instruments  of  pre-accession  strategy.  It  also  monitors  the  public  health  situation  in  these 
countries. 

Currently,  the  incidence  of  the  circulation  of  the  virus  A(H1N1)  appears  to  be  low  in  the 
candidates and potential candidates from where data are available. Therefore, the situation as 
regards the pandemic influenza seems not alarming to date. Measures have been taken by all 
the countries to prepare themselves for the treatment phase in case the virus starts spreading. 
Processes for purchasing the necessary vaccines and medication have been initiated, hospitals 
have  been  prepared  to  deal  with  a  possible  pandemic,  training  has  been  provided  for  health 
professionals,  measures  have  been  put  in  place  at  the  airports  and  ports,  public  information 
campaigns in the media and on governmental websites have been launched.  
European Neighbourhood Policy partners2 

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Candidates  (Croatia,  Turkey,  the  former  Yugoslav  Republic  of  Macedonia),  potential  candidates 
(Albania, Bosnia and Herzegovina, Kosovo (under UNSCR 1244/99), Montenegro, Serbia). 
Algeria, Armenia, Azerbaijan, Egypt, Georgia, Israel, Jordan, Lebanon,  Morocco, occupied Palestinian 
Territory, Republic of Moldova, Syria, Tunisia, Ukraine, as well as Belarus and Libya 

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European  Neighbourhood  Policy  (ENP)  partners  are  already  affected  by  pandemic  (H1N1) 
2009. The epidemiological and preparedness situation appears to be intermediate between the 
(potential)  candidates  and  the  developing  countries.  ENP  partners  continue  to  face  a  high 
burden  of  infectious  diseases  in  poor  and  rural  populations  and  in  some  neighbouring 
countries the financial resources for health remain insufficient.  

5. 

THE  CURRENT  ORGANISATION  OF  THE  GLOBAL  RESPONSE  TO  THE  PANDEMIC 
(H1N1) 2009 AND THE ROLE OF THE EUROPEAN COMMISSION 

As EU Member States are well prepared for a pandemic within Europe, the EU cannot ignore 
the potential consequences for the populations of third countries. This is an issue of solidarity 
and of efficiency in the face of a global crisis. 

Fortunately,  mechanisms  to  provide  a  global  response  to  this  potentially  highly  dangerous 
situation  already  exist.  Thus,  via  the  International  Health  Regulations,  the  international 
community  has  mandated  the  World  Health  Organisation  (WHO)  to  monitor  and  analyse 
the  overall  situation  and,  on  the  basis  of  the  best  available  evidence,  to  make  proposals  for 
appropriate  control  measures,  as  well  as  ensuring  the  proper  coordination  of  international 
support to the most needy countries. This would include vaccine availability in order to assist 
developing countries (including through humanitarian aid actors). 

The  European  Commission  maintains  constant  contact  with  WHO  and  UNSIC  in  order  to 
follow the development of the pandemic influenza (H1N1) 2009 and to share information and 
expertise  on  the  internal  EU  aspects  of  the  spread  of  the  virus.  Based  on  the  coordination 
mechanisms established for Avian Influenza, regular audio conferences are organised with the 
USA, Japan, Canada, Australia and the UN system. The Commission also uses these links to 
pay  special  attention  to  the  changing  situation  in  developing  countries  and  to  promote  a 
concerted and coordinated response.  

5.1. 

In developing countries  

Worldwide, developing countries are gradually stepping up their surveillance and response to 
epidemic and pandemic diseases. Following  H5N1 and SARS  alerts, and with financial and 
technical support from a number of EU countries, WHO has greatly increased its capacity (at 
both  global  and  regional  levels)  to  help  countries  build  their  emergency  preparedness  and 
response plans. 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. 

The European Commission has strongly contributed to global influenza preparedness through 
its leading role in the global response against Avian Influenza. From the onset of the Avian 
Influenza crisis, the Commission has adopted a broad-scope approach (“One Health” focusing 
on cross-sectoral co-operation), going largely beyond the sole challenge of Avian Influenza, 
focusing on the sustainable reinforcement of health systems and including general pandemic 
preparedness. Among other actions, the Commission has set up, hosted by the World Bank, 
the  Avian  and  Human  Influenza  Facility,  a  multidonor  trust  fund  to  which  the  Commission 
brings more than 80% of the funds and to which some EU MS also contribute. 

In recent years, new initiatives to prevent and respond to high impact infectious diseases and 
to  prepare  for  a  pandemic  have  been  taken,  like  for  instance  the  line  “Cross-border  co-
operation in animal and human health in Asia” in the regional strategy for Asia. A regional 
program  on  highly  pathogenic  emerging  and  re-emerging  diseases  in  Asia  is  about  to  be 
launched (including a grant agreement with WHO). 

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Also  thanks  to  these  efforts,  the  world  is  considerably  better  prepared  for  the  current 
pandemic.  Improvements  promoted  in  developing  countries  since  2006,  like  the  set  up  of 
inter-ministerial  structures  for  pandemic  preparedness  and  coordination,  and  the  design  of 
national pandemic plans, have been essential in the response to pandemic (H1N1) 2009. The 
contribution  of  the  EC  to  pandemic  preparedness  remains  active,  among  others  through  the 
programs currently in implementation. 

The  EU  has  played  an  active  role  in  the  Geneva-based  intergovernmental  meeting  on 
pandemic  influenza  preparedness  that  took  place  between  November  2007  and  May  2009 
following  the  resolution  of  the  World  Health  Assembly  WHA  62/10;  the  EU  currently 
participates  to  the  consultations  led  by  the  WHO  Director-General,  aiming  at  reaching  an 
agreement  on  viral  sample  sharing  and  benefits  for  developing  countries,  before  January 
2010. 

Finally,  the  Commission  and  the  successive  presidencies  of  the  EU,  have  been  largely 
instrumental  in  co-organizing  the  international  ministerial  conferences  and  senior  official 
meetings on avian and pandemic influenza (Beijing 2006, Vienna 2006, Bamako 2006, New 
Delhi  2007,  Sharm-el-Sheikh  2008).  The  Commission  is  actively  collaborating  to  the 
organization  of  the  next  international  ministerial  conference  that  will  take  place  in  Hanoi, 
Vietnam  in  April  2010.  The  current  H1N1  pandemic  is  one  of  the  topics  that  will  be 
addressed on that occasion. 

In  addition  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 influenza (H1N1) 2009. Such health systems' 
strengthening involves the provision of well-trained human resources, the proper maintenance 
of infrastructure, the provision of essential medicines and diagnostic aids as well as improving 
the  overall  governance  of  the  health  sector.  As  well  as  being  essential  components  of  the 
response to the pandemic influenza (H1N1) 2009, these elements are key for ensuring more 
equitable treatment of patients whatever their condition.  

5.2. 

In other third countries 

Candidates and potential candidates 
The  Instrument  for  Pre-Accession  Assistance  (IPA)3  is  intended  to  support  the  necessary 
political,  economic  and  institutional  reforms  in  the  preparations  for  EU  membership.  This 
usually  covers  support  for  the  adoption  or  progressive  alignment  with  the  public  health 
acquis,  institution  building  and  cross-border  cooperation.  Assistance  is  mobilised  with  a 
medium-term effect on the basis of a multi-annual strategic planning process. In exceptional 
cases, assistance within the existing envelopes could be re-directed and mobilised in a shorter 
term to help tackle to a certain extent the effects of pandemic A(H1N1).  

One  example  of  a  possible  short-term  measure  is  the  Technical  Assistance  and  Information 
Exchange  (TAIEX)  instrument.  This  assistance  takes  the  form  of  training  and  know-how 
transfer  events  (conferences,  seminars,  workshops  and  expert  mobilisation)  which  aim  to 
bring together the experience and knowledge of Member State experts and experts from the 
EU institutions with a targeted audience in the beneficiary countries. This instrument could be 
foreseen for some limited and targeted interventions linked for example to awareness raising 
on pandemic.  

3 

Council Regulation (EC) No 1085/2006. 

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European Neighbourhood Policy partners  

Most  of  the  ENP  partners  have  in  recent  years  improved  their  influenza  preparedness  and 
response  capacity.  The  European  Commission's  external  action  has  been  part  of  this  effort. 
There  is  increasing  EU-ENP  health  cooperation  and  dialogue  including  on  disease 
surveillance  and  outbreak  control.  ENP  Action  Plans  that  were  agreed  with  twelve  ENP 
countries include health cooperation objectives including objectives related to communicable 
diseases surveillance and improved health security. The November 2008 Euro-mediterranean 
health  ministerial  opened  new  opportunities 
to  strengthen  health  cooperation  with 
Mediterranean  partners.  Mediterranean  ENP  countries  participate  in  the  EpiSouth  Network 
for communicable diseases control in southern Europe and the Mediterranean, running under 
the  EC  public  health  programme.  Several  ENP  partners  expressed  interest  to  increase 
cooperation with ECDC.  
The EU is funding, under European Neighbourhood and Partnership Instrument, health sector 
budget support operations and major health projects in a range of ENP countries (e.g. Algeria, 
Egypt, Republic of Moldova, Morocco, Syria, occupied Palestinian Territory). They support 
the overall strengthening of health systems and contribute to a better diagnosis and treatment 
of patients, including those affected by pandemic influenza (H1N1) 2009. A number of ENP 
countries (e.g. Egypt, occupied Palestinian Territory) have benefited from support through the 
Avian and Human Influenza Facility trust fund.  

6. 

EC APPROACH TO THE GLOBAL DIMENSION OF THE PANDEMIC INFLUENZA (H1N1) 
2009 AND THE WAY FORWARD 

As part of its North-South solidarity, the European Commission must respond appropriately 
to the difficulties that developing countries face due to the pandemic influenza H1N1 2009. 
Furthermore the European Commission should be seen to be responding appropriately to the 
needs of the developing countries. The response could comprise the following elements:  

(1) 

(2) 

(3) 

The  Commission  confirms  its  support  for  the  lead  role  of  WHO  as  the  agency 
responsible for monitoring the evolution of pandemic influenza (H1N1) 2009 world-
wide, providing impartial and evidence-based advice on measures to be taken and for 
coordinating  the  support  of  the  international  community  to  countries  in  need.  It 
confirms its support to UNSIC in its coordinating role, inside the UN system and with 
international partners. 

The Commission will make every effort to maintain its support for the strengthening 
of  health  systems  in  developing  countries  as  a  priority  for  EC  development 
cooperation. The strengthening of health systems can only be done in accordance with 
the  needs  and  development  agendas  of  each  individual  country  and  must  respect  the 
principles of national ownership and aid effectiveness.  

The  European  Commission  humanitarian  aid  programmes  are  already  sensitised  to 
respond to novel flu through the support they provide to refugees, internally displaced 
people  and  victims  of  natural  disasters  or  conflicts,  -  groups  which  are  highly 
vulnerable  to  pandemic  influenza  (H1N1)  2009.  A  task  force  has  been  set  up  in  the 
Directorate-General for Humanitarian Aid has organised internally a close monitoring 
of  the  evolution  of  the  pandemic  influenza  (H1N1)  2009  risk,  and  to  coordinate  and 
adapt regularly the humanitarian response strategy. If the pandemic influenza (H1N1) 
2009  intensifies,  emergency  interventions  could  be  rapidly  launched  as  and  where 
needed by the Directorate-General for Humanitarian Aid. 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

The  Commission  will  monitor  the  global  effects  of  EU  internal  policies  and  actions, 
particularly  on  developing  countries.  The  Commission  will  encourage  the  EU  to 
implement the WHO-led support for improved global availability of the means needed 
to  combat  the  pandemic  influenza  (H1N1)  2009  threat,  including  a  more  equitable 
access  to  vaccines  when  they  become  available.  In  line  with  WHO  Director-General 
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. 

The  EU  has  a  major  role  to  play  having  the  largest  share  of  relevant  vaccine-
production  capacity  and  the  greatest  share  of  advance  purchase  agreements.  In  this 
respect,  adequate  negotiations  with  producers,  including  the  possibility  of  generic 
production,  tiered  pricing,  assigning  a  share  of  vaccines  and  anti-viral  medicines  for 
developing  countries  and  other  means  to  render  vaccines  accessible  should  be 
considered as part of the global dimension of the response. Any funds needed should 
be additional and come separately from the already assigned development cooperation 
and humanitarian aid funds. 

The  Commission  will  closely  monitor  developments  of  the  pandemic  influenza 
(H1N1) 2009 and, if need be, is ready to propose to member States and the European 
Parliament to apply additional flexibility in the operation of its programs and financial 
flows  for  developing  countries.  Under  the  current  DG  RELEX  programming, 
resources  are  very  limited  and  there  is  little  if  any  margin  for  manoeuvre.  In  this 
respect  RELEX  interventions  would  need  to  take  place  in  the  framework  of  the 
existing  commitments  and  current  or  programmed  resource  allocations  at  country  or 
regional level.  

The  Commission  will  monitor  the  implementation  of  this  response  to  the  pandemic 
(H1N1)  2009  and  draw  lessons  regarding  best  practice  interventions  in  case  of  any 
future,  similar  crisis.  Such  lessons  would  apply  to  knowledge  generation,  research, 
strengthening of policy and intervention capacities.  

The European Commission is considering whether the special inter-service Task Force 
which has been set up to deal with the external aspects of pandemic influenza H5N1 
should have its mandate extended to include the impact of pandemic influenza (H1N1) 
2009. 

The  European  Commission  will  encourage  the  gradual  development  of  cooperation 
between  ECDC  and  certain  third  countries,  notably  those  covered  by  the  European 
Neighbourhood Policy. 

Member  States  and/or  third  countries  confronted  with  an  emergency  that  overwhelms  their 
national  response  capability  can,  at  any  time,  also  activate  the  Community  Mechanism  for 
Civil  Protection  to  pool  immediate  civil  protection  and  medical  assistance  that  could  be 
available in other Member States. 

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