Commission staff working document on joint procurement of vaccine against influenza A(H1N1) accompanying document to the Communication from the Commission to the Council, the European Parliament and the European Economic and Social Committee and the Committee of the Regions - Pandemic (H1N1) 2009 {COM(2009) 481} {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, infectious disease, public health, vaccination, vaccine

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

Pandemic (H1N1) 2009 

{COM(2009) 481} 
{SEC(2009) 1189} 
{SEC(2009) 1190} 
{SEC(2009) 1191} 
{SEC(2009) 1192} 

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1. 

INTRODUCTION 

In  the  preparation  for  an  expected  increase  of  infection  by  influenza  A(H1N1)  2009  virus 
from  the  autumn  onwards,  vaccines  play  an  important  role.  Indeed,  vaccination  with  a 
pandemic  vaccine  effective  against  the  influenza  A(H1N1)  2009  virus  can  be  considered  as 
one of the most effective public health measures.  

As  specific  vaccines  can  only  be  developed  once  the  pandemic  influenza  strain  has  been 
isolated, the vaccine will initially only be available in limited quantities and the demand may 
initially be higher than the supply. The initial limited amount 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. 

A  number  of  Member  States  have  already  purchase  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 two doses, other Member States have not started procurement 
procedures or yet concluded purchase agreement with industry. 

In  this  context  of  limited  number  of  producers  for  the  vaccine,  time  constraints  for  its 
production and of the need to ensure adequate coverage of priority and target groups of the 
population,  coordination  among  all  actors  should  be  considered  as  a  matter  of  urgency 
focusing on identifying and putting in place possible mechanisms to help Member States to 
protect  their  citizens  against  the  current  pandemic  influenza  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 place, the Swedish Presidency proposed asking the 
Commission  to  set  up  a  mechanism  to  help  joint  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 characteristic is that there normally is only one tender published 
on behalf of all participating authorities. Joint procurement activities are not new in a number 
of  Member  States  where  the  public  authorities  have  been  buying  together  for  a  number  of 
years; but not all Member States have experience in this area. 

There  are  several  benefits  for  contracting  authorities  engaging  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  administrative  work  for  the  group  of  authorities 
involved  in  preparing  and  carrying  out  one  rather  than  several  tenders  can  be  substantially 

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reduced. How much it is reduced will depend on the type of joint procurement arrangement 
used.  

Skills and expertise – Joining the procurement actions of several authorities also enables the 
pooling  of  different  expertise  between  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 against influenza A(H1N1) 2009, in addition to the 
benefits  mentioned  above  will  increase  the  total  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 presidency and in order to establish the level of 
interest among Member States, the Commission sent 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  contact  meeting  can  be  organised  soon.  Several 
Member States have already favourably responded to the Commission.  

Members of the Health Security Committee (HSC) and the National authorities of the Early 
Warning and Response System (EWRS) have been informed of the (possible) initiative during 
the regular meeting on the 14 August. The initiative was acknowledged and it was underlined 
that  the  current  experience  of  those  Member  States  who  have  already  signed  advanced 
purchase agreements with the producers could be of added value in helping the initiative. 

4. 

BEING IN LINE WITH THE CURRENT EU AND NATIONAL LEGISLATION 

According to the objectives of the Community action 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.  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. In this case, a joint procurement of 
the  specific  vaccine  against  influenza  A(H1N1)  will  complement  the  national  policy  in 
Member States. 

Joint procurement involving several Member States would be in line with the Community law 
on  public  procurement  in  accordance  with  the  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  national  levels  could  challenge  the  procedure  as 
contracting authorities normally have to apply 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.  

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Competition rules apply in principle to all economic activities whether carried out by private 
or public undertakings. It is indeed a settled case 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  carries  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 distinguished 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  apply.  Only  where  the  Member  States  or  the 
Commission  would  consider  carrying  out  activities  of  an  economic  nature  involving  the 
vaccines at hand, competition rules may become applicable to those activities (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  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.  

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 advanced purchase agreements 
and those having not yet concluded such agreements.  

For the mid and long term the Commission will continue exploring alternative procedures. 

The  second  area  for  cooperation  could  be  in  the  sharing  of  stocks  between  Member  States: 
During  the  informal  meeting  of  the  EU  Health  Ministers  in  Jönköping  on  6-7  July  2009,  it 
was suggested that the Commission would facilitate countries that possess vaccines, to make 
voluntary  sales  to  other  countries.  In  view  of  the  imbalance  between  a  high  supply  of  the 
vaccine in one Member State and a shortage, or even a lack, of the vaccine in another, a cross-
border exchange of vaccines may need to be considered. 

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2 

Case 118/85 Commission v Italy [1987] ECR 2599, paragraph 7 
Case  C-364/92  SAT  Fluggesellschaft  v  Eurocontrol  [1994]  ECR  I-43,  paragraph  30  (regarding 
environmental measures). 

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In this perspective the Commission 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.  

6. 

OPEN THE POSSIBILITY TO THE CANDIDATES AND POTENTIAL CANDIDATES AND TO 
THE NEIGHBOURING COUNTRIES – THE INTERNATIONAL DIMENSION 

Neighbouring countries and candidates and potential candidates may also be involved in the 
initiative  with  Member  States.  The  international  dimension  is  addressed  in  the  specific 
Commission  staff  working  documents  on  'Support  to  Third  Countries  to  fight  the  H1N1 
influenza'.  

In general the EU policy on the issue of support to third countries will include the availability 
and accessibility of the means needed to combat 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  providers,  security  forces)  and  when  the  vaccine  should  be 
distributed. 

The Commission is working closely 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 basis of vaccination strategies implemented; and 
what  will  be  the  requirements  of  least  developed  countries.  Some  vaccine  producers  have 
already  committed  10%  of  the  production  to  be  reserved  for  the  WHO  to  distribute  to 
countries in need. 

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