EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 15.9.2009 
SEC(2009) 1188 final 
  
COMMISSION STAFF WORKING DOCUMENT 
on Joint procurement of vaccine against influenza A(H1N1) 
 
Accompanying document to the 
 
COMMUNICATION FROM THE COMMI SSION TO THE COUNCIL,  
THE EUROPEAN PARLIAMENT AN D THE EUROPEAN ECONOMIC AND 
SOCIAL COMMITTEE AND THE CO MMITTEE OF THE REGIONS 
Pandemic (H1N1) 2009  
{COM(2009) 481} 
{SEC(2009) 1189} {SEC(2009) 1190} {SEC(2009) 1191} {SEC(2009) 1192} 
 
EN 2   EN 1. INTRODUCTION  
In the preparation for an expected increase  of infection by infl uenza A(H1N1) 2009 virus 
from the autumn onwards, vaccines play an important role. Indeed , vaccination with a 
pandemic vaccine effective against the influe nza A(H1N1) 2009 virus can be considered as 
one of the most effective public health measures.  
As specific vaccines can only be developed on ce the pandemic influenza strain has been 
isolated, the vaccine will initially only be available in limited quant ities and the demand may 
initially be higher than the supply. The initial limited amount of vaccin es, together with the 
potential need for a large scale vaccination cam paign poses challenges to  healthcare systems 
and highlights the need for a care fully planned vaccination strategy. 
A number of Member States have already pu rchase agreements with  the producers and the 
situation is rapidly evolving. While a number of  Member States have already committed to 
cover the entire population with tw o doses, other Member States have not started procurement 
procedures or yet concluded pur chase agreement with industry. 
In this context of limited number of produ cers for the vaccine, time constraints for its 
production and of the need to ensure adequate c overage of priority and target groups of the 
population, coordination among all actors should be considered as a matter of urgency 
focusing on identifying and putti ng in place possible mechanisms to help Member States to 
protect their citizens against the current pandemic influe nza A(H1N1). In addition, such 
mechanisms will be of relevant added value in  preparing the EU to respond in a coordinated 
way to this health threat.  
During the informal Health Council of 6 July and on the basis of a large consensus on 
pursuing joint procurement of vaccine against influenza A(H1N1) 2009, in particular for those 
Member States with no current orders in pl ace, the Swedish Presidency proposed asking the 
Commission to set up a mechanism to help jo int procurement of vaccines for interested 
Member States. This was supported by a majority of Member States.  
2. DEFINITION AND ADDED VALUE FOR JOINT PROCUREMENT  
'Joint procurement'  means combining the procurement actions of two or more contracting 
authorities. The key defining charac teristic is that there normally is only one tender published 
on behalf of all participating au thorities. Joint procurement ac tivities are not new in a number 
of Member States where the public authoritie s have been buying together for a number of 
years; but not all Member States have experience in this area. 
There are several benefits fo r contracting authorities e ngaging in joint procurement 
arrangements: 
Lower prices – Combining purchasing activities can  lead to economies of scale. This is likely 
to lead to more attractive offers from suppliers . Particularly for small contracting authorities, 
these advantages can be quite significant. 
Administrative cost savings – The total admi nistrative work for the group of authorities 
involved in preparing and carrying out one rather  than several tenders can be substantially 
 
EN 3   EN reduced. How much it is reduced will depend on  the type of joint procurement arrangement 
used.  
Skills and expertise – Joining the procurement ac tions of several authorities also enables the 
pooling of different expertise be tween the authorities. Smaller authorities in particular can 
benefit from the capacities of staff in larger authorities.  
3. BACKGROUND AND OBJECTIVES  
A joint procurement initiative of vaccine ag ainst influenza A(H1N1) 2009, in addition to the 
benefits mentioned above will increase the tota l number of doses rapidly available to the 
priority groups in the Member States. This fact  will help the national authorities to proceed 
with the vaccination strategy forecasted at National level. The ad hoc Commission staff 
working document on 'Vaccination Strategies against Influenza A(H1N1) 2009' covers in 
detail the issues related to the topic at EU level.  
As a follow up of the call from the Swedish presid ency and in order to establish the level of 
interest among Member States, the Commission se nt a letter to the Member States asking if 
they would be interested in participating in  joint procurement of vaccines and if so to 
nominate a representative so that a first co ntact meeting can be organised soon. Several 
Member States have already favour ably responded to the Commission.  
Members of the Health Securi ty Committee (HSC) and the National authorities of the Early 
Warning and Response System (EWRS) have been informed of the (possi ble) initiative during 
the regular meeting on the 14 August. The initia tive was acknowledged a nd it was underlined 
that the current experience of those Member  States who have al ready signed advanced 
purchase agreements with the producers could be  of added value in he lping the initiative. 
4. BEING IN LINE WITH THE CURRENT EU AND NATIONAL LEGISLATION  
According to the objectives of the Community actio n in the field of public health as set out in 
Article 152 of the Treaty, 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. Su ch action shall cover the fight against the 
major health scourges by promoting research in to their causes, their transmission and their 
prevention, as well as health in formation and educati on. In this case, a joint procurement of 
the specific vaccine against influenza A(H1 N1) will complement the national policy in 
Member States. 
Joint procurement involving several Member Stat es would be in line with the Community law 
on public procurement in accordance with th e national transposition of the European 
Community Public Procurement Directives. This  legal frame provides a basis for the Member 
States to coordinate their efforts in procurement.  
However, potential constraints at the nationa l levels could challenge the procedure as 
contracting authorities normally have to appl y their own national procurement rules and the 
transposition laws in the Member States are quite diverse as the EC  Directives are only 
coordinating but not harmonising European procurement rules.  
 
EN 4   EN Competition rules apply in principle to all economic activities whether carried out by private 
or public undertakings. It is indeed a settled ca se law that the notion of "undertaking" for the 
purposes of EC competition rules can cover any entity engaged in an economic activity, 
regardless of the legal status of that entity. However, a distinction must be drawn between a 
situation where the State acts as a mere purchaser  in the exercise of its competence as public 
authority and that where it ca rries on economic activities of an industrial or commercial 
nature by offering goods or  services on the market1. The joint procurement of the pandemic 
vaccine by Member States appears to constitute a measure of public health typically exercised 
by a public authority and can as such be distingu ished from an activity of economic nature to 
which the application of competition rules of the Treaty may be justified2. As a result, it is 
unlikely that EC competition rules would ap ply. Only where the Member States or the 
Commission would consider carrying out activiti es of an economic na ture involving the 
vaccines at hand, competition rules may become a pplicable to those acti vities (e.g., regarding 
subsequent (re)sale of vaccines, etc…). 
5. POTENTIAL ACTIONS FOR 'JOINT PROCUREMENT ' OF VACCINE AGAINST INFLUENZA 
A(H1N1)  2009   
Given the stage of development of the pandemi c, 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 availa bility of supply of vaccines for target and 
priority groups in the timeframe available.  
The Commission will support the Me mber 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 advanced purchase agreements 
and those having not yet concluded such agreements.  
For the mid and long term the Commission will continue exploring al ternative procedures. 
The second area for cooperation could be in th e sharing of stocks between Member States: 
During the informal meeting of the EU H ealth Ministers in Jönköping on 6-7 July 2009, it 
was suggested that the Commissi on would facilitate countries th at possess vaccines, to make 
voluntary sales to other countri es. In view of the imbalan ce between a high supply of the 
vaccine in one Member State and a shortage, or ev en a lack, of the vaccine in another, a cross-
border exchange of vaccines may need to be considered. 
                                                
 
1 Case 118/85 Commission v Italy [1987] ECR 2599, paragraph 7 
2 Case C-364/92 SAT Fluggesellschaft v Eurocontrol [1994] ECR I-43, paragraph 30 (regarding 
environmental measures). 
 
EN 5   EN In this perspective the Commission encourages, in parallel to the joint procurement initiative, 
a common approach to cross-border sharing a nd voluntary sale within the EU. A mechanism 
to envisage cooperation between Member States in order to a ddress shortages of vaccine in 
one Member State and high supplies in anothe r country could be envisaged and might be 
coordinated at EU level. On the basis of the replies receive d so far by the Commission, some 
Member States have already included in the co ntracts that vaccines, which are not used, can 
be sold to other countries.  
6. OPEN THE POSSIBILITY TO THE CANDIDATES AND POTENTIAL CANDIDATES AND TO 
THE NEIGHBOURING COUNTRIES – THE INTERNATIONAL DIMENSION  
Neighbouring countries and candidates and potentia l candidates may also be involved in the 
initiative with Member States. The international dimension is addressed in the specific Commission staff working documents on 'Suppor t to Third Countries to fight the H1N1 
influenza'.  
In general the EU policy on the i ssue of support to third countrie s will include th e availability 
and accessibility of the means needed to comb at the pandemic influenza (H1N1) 2009 threat, 
including a more equitable access to vaccines when they become available, and will be in line with the technical recommendations proposed by the WHO as regards to whom (i.e. at-risk 
populations, health-care provid ers, security forces) and when the vaccine should be 
distributed. 
The Commission is working clos ely with the WHO to assess the global production capacities 
for these vaccines; to determine which part of this production has been already ordered 
(advanced purchases) by rich countries, including EU Member States, what will be the demands by the EU Member States on the basi s of vaccination strategies implemented; and 
what will be the requirements of least develo ped countries. Some vaccine producers have 
already committed 10% of the production to be reserved for the WHO to distribute to 
countries in need.