EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN 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 CO MMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMI TTEE OF THE REGIONS 
Pandemic (H1N1) 2009  
{COM(2009) 481} 
{SEC(2009) 1188} {SEC(2009) 1189} {SEC(2009) 1190} {SEC(2009) 1191} 
 
EN 2   EN 1. INTRODUCTION  
In April 2009, a novel stra in 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, her eafter 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 WH O region and in at least one 
other country in a different WHO region. The d eclaration therefore wa s a reflection of the 
spread of the new virus, not the severity of illness caused by it.  
This recognition of pandemic (H1N1) 2009 implie s that all countries could or would be 
affected and that a globally concerted respon se 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, th e EU cannot ignore the po tential consequences 
for the populations of third countries, in particul ar 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 pr epare 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 issu es 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 fo r 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' awar eness, 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 re ported 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 measur es, as well as ensuring the proper coordination 
of international support to the most needy countries.  
The European Commission has been activel y supporting the global response to Avian 
Influenza politically, technically and financially  by setting up of and co ntributing to a World 
Bank (WB) trust fund for example. .The Commission has also developed good working 
relations with the UN senior influenza c oordination (UNSIC) and with international 
organisations such as WHO, World Organisati on for Animal Health OIE and WB and built a 
pool of EC/EU internal expertise and a foru m for exchanging information that could be 
widened to cope with this new pandemic. 
 
EN 3   EN 2. PURPOSE AND OBJECTIVES  
The key specific objective of the current docu ment is to identify areas and mechanisms by 
which the needs of third countries could be sup ported with the aim of steadily increasing their 
level of protection in the face of the pande mic influenza (H1N1) 2009, while respecting the 
principles of country owners hip and aid effectiveness. 
In particular, the European Commission s hould address the following specific objectives 
• To closely monitor the situation in third co untries, 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 countri es, 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 wa y 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. L
EGAL ASPECTS  
According to the objectives of the Community actio n in the field of public health as set out in 
Article 152 of the Treaty, the Community and th e Member States shal l foster cooperation 
with third countries and the competent internat ional organisations in the sphere of public 
health. Community action shall complement na tional policies, shall be directed towards 
improving public health, preventing human illn ess 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 cau ses, their transmission and their prevention, as well as health 
information and education.  
On the other hand, based on Article 177 to 1 81 of the Treaty, and a ccording to the EU 
Consensus for Development adopted by the Eu ropean Union in 2006, th e Union commits to 
the principles of ownership of development st rategies 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 prov ide more and better aid, and to take action to 
advance policy coherence for development. Th ese commitments have been confirmed more 
recently in the Accra Agenda for action on ai d effectiveness adopted in September 2008.  
4. SITUATION AND NEEDS OF THIRD COUNTRIES  
4.1. Developing Countries 
From a scientific poin t 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 impa ct 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 pandemi c, while in the EU/EFTA 40156 cas es and 63 deaths had been 
notified (situation as at 19 A ugust 2009). This difference in reported cases probably reflects 
more the capacity of diagnos ing and reporting the disease than actual differences in 
occurrence. 
 
EN 4   EN Developing countries alrea dy suffer from a high disease burden from many endemic 
infectious diseases. Their capacity to monitor, pr event and react in the ca se of acute outbreaks 
of more common infectious diseases (such as me ningitis or cholera) is very limited. They are 
obliged to run their hea lth systems with consider ably 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 inte rnational 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 Deve lopment Goal fallouts.. In the context of the 
international response to the global financial cr isis and in line with commitments undertaken 
at the G20 London Summit of 2 April 2009, the European Commi ssion has set up an ad hoc 
mechanism, the Vulnerability FLEX, which is exp ected to play a role in preserving the level 
of public social service provision.  
Nevertheless, the social impact of the pande mic influenza (H1N1) 2009 serves as a strong 
reminder that we are still very far from bei ng 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 negotia tor with manufacturers on vaccine production, 
pricing and procurement, shoul d provide adequate details of current global production 
capacity and on the potential global needs for vaccine supplies.  
4.2. Other third countries 
Candidates and potential candidates
1 
In the context of the enlargement policy, th e Commission helps legal alignment with the 
acquis  in the area of pu blic health in the candidates and po tential candidates, and supports and 
monitors the implementation and effective enforc ement of national legisl ation through various 
instruments of pre-accession strategy. It also monitors the public hea lth 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 trea tment 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 plac e at the airports and ports, public information 
campaigns in the media and on governmental websites have been launched.  
European Neighbourhood Policy partners2 
                                                 
1 Candidates (Croatia, Turkey, the former Yugoslav Republic of Macedonia), potential candidates 
(Albania, Bosnia and Herzegovina, Kosovo (under UNSCR 1244/99), Montenegro, Serbia). 
2 Algeria, Armenia, Azerbaijan, Egyp t, Georgia, Israel, Jordan, Lebano n,  Morocco, occu pied Palestinian 
Territory, Republic of Moldova, Syria, Tuni sia, Ukraine, as well as Belarus and Libya 
 
EN 5   EN European Neighbourhood Policy (ENP) partners are already affected by pandemic (H1N1) 
2009. The epidemiological and preparedness situa tion appears to be intermediate between the 
(potential) candidates and the de veloping countries. ENP partners  continue to face a high 
burden of infectious diseases in poor a nd rural populations and in some neighbouring 
countries the financial resources fo r 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 potenti ally 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 ensu ring the proper coordination of international 
support to the most needy countries. This would in clude vaccine availability in order to assist 
developing countries (including th rough 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 sp read of the virus. Ba sed on the coordination 
mechanisms established for Avian Influenza, re gular audio conferences are organised with the 
USA, Japan, Canada, Australia and the UN syst em. The Commission also uses these links to 
pay special attention to the changing situatio n in developing countries and to promote a 
concerted and coordinated response.  
5.1. In developing countries  
Worldwide, developing countries  are gradually stepping up thei r 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 thei r emergency preparedness and 
response plans. All donor support to  the health sector in developing countries has to respect 
country leadership in strategy design and ow nership of the implem entation 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 contribute d 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 he alth systems and including general pandemic 
preparedness. Among other actions, the Comm ission 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 strate gy for Asia. A regional 
program on highly pathogenic em erging and re-emerging diseases  in Asia is about to be 
launched (including a grant agreement with WHO). 
 
EN 6   EN Also thanks to these efforts, the world is considerably better prepared for the current 
pandemic. Improvements promoted in devel oping countries since 2006, like the set up of 
inter-ministerial structures for pandemic pr eparedness and coordination, and the design of 
national pandemic plans, have been essentia l in the response to pandemic (H1N1) 2009. The 
contribution of the EC to pandemic prepared ness remains active, am ong 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 countr ies, before January 
2010. 
Finally, the Commission and the successive presidencies of the EU, have been largely 
instrumental in co-organizing the internationa l ministerial conferences and senior official 
meetings on avian and pandemic influe nza (Beijing 2006, Vienna 2006, Bamako 2006, New 
Delhi 2007, Sharm-el-Sheikh 2008). The Commi ssion is actively collaborating to the 
organization of the next international minister ial 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 Co mmission is providing funding to a number of low income 
countries through a range of bilateral measures (p rojects, health sector budget support, general 
budget support and regional programmes), so that  their national health systems can respond 
more adequately to the challenge of pandemi c influenza (H1N1) 2009. Such health systems' 
strengthening involves the provi sion of well-trained human re sources, the proper maintenance 
of infrastructure, the provision of essential me dicines 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 poten tial 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 coope ration. 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 c ould be re-directed and mobilised in a shorter 
term to help tackle to a certain exte nt 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 interv entions linked for example to awareness raising 
on pandemic.   
                                                
 
3 Council Regulation (EC) No 1085/2006. 
 
EN 7   EN European Neighbourhood Policy partners  
Most of the ENP partners have in recent ye ars improved their influenza preparedness and 
response capacity. The European Commission's exte rnal action has been part of this effort. 
There is increasing EU-ENP health coop eration and dialogue including on disease 
surveillance and outbreak control. ENP Action Plans that were agreed with twelve ENP 
countries include health coope ration objectives including objec tives 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 co untries participate in the EpiSouth Network 
for communicable diseases control in southe rn Europe and the Me diterranean, running under 
the EC public health programme. Several ENP partners expressed interest to increase 
cooperation with ECDC.  The EU is funding, under European Neighbourhood a nd Partnership Instrument, health sector 
budget support operations and major health projects in a range of ENP countries (e.g. Algeria, 
Egypt, Republic of Moldova, Moro cco, Syria, occupied Palestin ian Territory). They support 
the overall strengthening of health systems and contribute to a better diagnosis and treatment 
of patients, including those affected by pande mic influenza (H1N1) 2009. A number of ENP 
countries (e.g. Egypt, occupied Palestinian Te rritory) 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 Eu ropean 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 respons e could comprise the following elements:  
(1) The Commission confirms its support for th e lead role of W HO 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 internati onal community to countries in need. It 
confirms its support to UNSIC in its coordi nating role, inside th e UN system and with 
international partners. 
(2) The Commission will make every effort to maintain its support for the strengthening 
of health systems in deve loping countries as a prio rity 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 owners hip and aid effectiveness.  
(3) The European Commission humanitarian ai d 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 Human itarian Aid has organised inte rnally a close monitoring 
of the evolution of the pa ndemic influenza (H1N1) 2009 risk, and to coordinate and 
adapt regularly the humanitari an 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. 
 
EN 8   EN (4) The Commission will monitor the global eff ects of EU internal policies and actions, 
particularly on developing countries. Th e Commission will encourage the EU to 
implement the WHO-led support for improved gl obal availability of  the means needed 
to combat the pandemic influenza (H1N1)  2009 threat, including a more equitable 
access to vaccines when they become availabl e. In line with WHO Director-General 
call for international solidarity to provide fa ir and equitable access for all countries to 
pandemic vaccine when it becomes available, the possibility to reserve for developing countries a share of vacci nes ordered by Member St ates should be seriously 
considered. 
(5) The EU has a major role to play having the largest share of relevant vaccine-
production capacity and the grea test share of advance purc hase agreements. In this 
respect, adequate negotiati ons 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 dimensi on of the response. A ny funds needed should 
be additional and come separately from the already assigned development cooperation 
and humanitarian aid funds. 
(6) The Commission will closely monitor de velopments of the pandemic influenza 
(H1N1) 2009 and, if need be, is ready to pr opose to member States and the European 
Parliament to apply additional flexibility in the operation of its programs and financial 
flows for developing c ountries. 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 programm ed resource allocations at country or 
regional level.  
(7) The Commission will monitor the implemen tation of this response to the pandemic 
(H1N1) 2009 and draw lessons regarding best  practice interventi ons in case of any 
future, similar crisis. Such lessons woul d apply to knowledge generation, research, 
strengthening of policy a nd intervention capacities.  
(8) The European Commission is considering whether the special inter-service Task Force 
which has been set up to deal with the ex ternal aspects of pandemic influenza H5N1 
should have its mandate extended to include  the impact of pandemic influenza (H1N1) 
2009. 
(9) The European Commission will encourage the gradual development of cooperation 
between ECDC and certain third countries , notably those cove red by the European 
Neighbourhood Policy. 
Member States and/or third countries confront ed 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 prot ection and medical assi stance that could be 
available in other Member States.