Proposal for a Council Regulation setting up the Innovative Medicines Initiative Joint Undertaking [SEC(2007) 568] [SEC(2007) 569]
Date: 2007-05-15
Institutions: European Commission
Subjects: innovation, joint venture, legal status, medicinal product, pharmaceutical industry, research policy

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 15.5.2007 
COM(2007) 241 final 

2007/0089 (CNS) 

Proposal for a 

COUNCIL REGULATION 

setting up the Innovative Medicines Initiative Joint Undertaking 

(presented by the Commission) 

[SEC(2007) 568] 
[SEC(2007) 569] 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Grounds  for  and  objectives  of  the  proposed  Innovative  Medicines  Initiative 
Joint Undertaking 

Joint  Technology  Initiatives  (JTIs)  are  introduced  in  the  Seventh  Framework 
Programme1 (FP7) as a new way of realising public-private partnerships in research 
at  European  level.  JTIs  are  an  expression  of  the  EU's  strong  commitment  to 
coordinating  research  efforts,  so  contributing  to  the  realisation  of  the  European 
Research Area and Europe's competitiveness goals. 

JTIs arise primarily from the work of European Technology Platforms (ETPs). In a 
small number of cases, ETPs have achieved such an ambitious scale and scope that 
they will require the mobilisation of high public and private investments as well as 
substantial  research  resources  to  implement  important  elements  of  their  Strategic 
Research Agendas. JTIs are proposed as an effective means of meeting the needs of 
this small number of ETPs.  

In the Co-operation Specific Programme2 six areas are identified where a JTI could 
have  particular  relevance:  hydrogen  and  fuel  cells,  aeronautics  and  air  transport, 
innovative  medicines,  embedded  computing  systems,  nanoelectronics  and  GMES 
(global monitoring for environment and security).  

Against  this  background,  the  Innovative  Medicines  Initiative  Joint  Undertaking 
(IMI JU) is the legal entity that will be responsible for implementation of the Joint 
Technology  Initiative  on  Innovative  Medicines  (IMI  JTI).  This  initiative  will 
strengthen  Europe’s  position  in  pharmaceutical  research.  It  will  re-invigorate  the 
European pharmaceutical sector, make Europe more attractive to research investment 
and,  in  the  long  term  provide  European  citizens  with  faster  access  to  better 
medicines. 

in 

the  pharmaceutical  sector.  For 

Drug development is a very long and costly process. Having once been world leader 
in  pharmaceutical  research,  Europe  is  now  lagging  in  research  investment,  both 
public  and  private.  The  IMI  JTI  aims  to  improve  this  situation  by  a  unique 
collaboration 
time,  competitor 
pharmaceutical  companies  will  collaborate  on  research  to  improve  the  drug 
development  process.  Participation  of  academia  and  clinical  centres,  small  and 
medium  sized  enterprises  (SMEs),  patient  organisations  and  public  authorities 
(including  regulators)  will  be  essential  and  will  lead  to  faster  uptake  of  results. 
Traditional  EU  collaborative  research  instruments  cannot  achieve  the  co-ordination 
of  research  efforts  necessary  to  cope  with  the  scale  and  complexity  of  the  research 
challenges involved. 

the  first 

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OJ L 412, 30.12.2006, p.1 
OJ L 400, 30.12.2006, p. 66-241 

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Competencies and resources from the private and the public sectors will be pooled in 
a  public-private  partnership  to  be  founded  as  a  Joint  Undertaking  by  the  European 
Commission (EC) and EFPIA (the European Federation of Pharmaceutical Industries 
and  Association).  The  IMI  JU  will  be  set  up  as  a  Community  body  by  a  Council 
Regulation  under  Article  171  of  the  Treaty.  It  will  have  a  total  budget  of  EUR  2 
billion. The EC will contribute with EUR1 billion from FP7. The other EUR1 billion 
will be contributed by EFPIA and the research-based pharmaceutical companies that 
are full members of EFPIA. 

The IMI JU will support research activities conducted in the Member States and in 
the  countries  associated  with  FP7,  following  open  calls  for  proposals.  The 
Community  contribution  will  be  used  exclusively  to  support  academia  and  clinical 
centres,  SMEs,  patient  organisations  and  public  authorities  (including  regulators). 
The  EFPIA  member  companies  will  carry  the  costs  of  their  part  of  the  research 
collaboration at a value equal to the Community contribution. 

General Context 

The  pharmaceutical  industry  is  important  for  the  knowledge  based  economy.  As  a 
research-intensive sector, it contributes significantly to European innovation climate 
and economy. Investing around 15% of its turnover in research and development, it 
provides Europe with high-skill jobs (612,000 employees in 2004, of which 103,000 
in  research),  high-value  products,  crucial  to  the  health  and  well-being  of  European 
citizens, and benefits other economic sectors. 

The impact of pharmaceutical sector to the economy is often discussed only in terms 
of costs to the public health system. However, it should be stressed that innovative 
medicines produce considerable economic benefits including: 

•  increased total economic production value (e.g. avoiding temporary disabilities, or 

decreasing their length), 

•  reinforced  employment,  through  research,  production,  and  distribution  of 

innovative medications, 

•  added value through highly trained people, 

•  eased  burden  on  public  health  (e.g.  reducing  hospital  stays),  and  on  pension 

systems (e.g. avoiding early pension eligibility),  

•  increased quality of life (e.g. reduced morbidity and mortality). 

IMI  addresses  the  issue  of  Europe's  relative  decline  in  pharmaceutical  research  by 
focussing on the main challenges to: 

–  improve  prediction  of  the  safety  and  the  efficacy  of  new  drug  candidates  in  the 

early development phases, before the costly clinical trials begin;  

–  tackle the current multiplication of research efforts, both in the private and public 

sector, by jointly developed knowledge management systems;  

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–  bridge  gaps  in  training  of  professionals  to  ensure  a  more  skilled  workforce  in 

Europe for this sector. 

In  addition,  IMI  will  serve  as  a  focal  point  to  for  developing  synergies  between 
research  and  collaboration  with  national,  European  and  international  activities  and 
will contribute to establishing the European Research Area in this sector. 

A paradigm shift in collaborative patterns will be necessary to meet these challenges. 
Traditionally,  pharmaceutical  companies  work  on  a  one-to-one  basis  with  partners 
such  as  universities,  SMEs  to  develop  new  drugs.  The  present  challenges  demand 
research  and  development  on  tools  and  methodologies  that  can  be  used  by  all 
companies  active  in  the  drug  development  process.  Today  industry  investment  in 
such  research  is  very  low,  and  collaboration  between  these  highly  competitive 
companies is rare. In addition, industry does not have all the necessary competencies 
to  carry  out  this  complex  research  alone.  This  is  why  a  new  approach  at  European 
level  is  needed,  with  academia  and  clinical  centres,  SMEs,  patient  organisations, 
public authorities (including regulators) working together with industry. 

EFPIA,  a  non-profit  organization  representing  the  research-based  pharmaceutical 
industry  in  Europe,  took  the  lead  in  setting  up  the  ETP  on  Innovative  Medicines. 
Following  consultation  with  a  wide  spectrum  of  stakeholders,  the  Innovative 
Medicines  ETP  developed  a  Strategic  Research  Agenda  (SRA)  detailing  the 
challenges  discussed  above  and  ways  to  tackle  them.  The  European  Commission 
brought  together  representatives  from  the  Member  States  and  from  the  Countries 
associated to FP6. This group has met regularly and has actively supported the ETP 
by  providing  constructive  comments,  ideas  and  experiences  based  on  national 
activities in the area. 

The  JTI  is  the  most  appropriate  means  of  co-ordinating  efforts  given  the  scale  and 
complexity  of  the  research  challenges.  Therefore,  the  Commission  proposed  the 
implementation of the SRA on Innovative Medicines as a JTI in its proposal for FP7 
confirmed through the co-decision by the Council and the European Parliament. 

The  proposed  governance  structure  for  the  IMI  JTI,  which  has  been  developed 
though a close collaboration between the Commission and EFPIA clearly reflects the 
public-private nature of the initiative. In their role as founders, the Commission and 
EFPIA will equally share the responsibilities and costs for the implementation of the 
IMI JTI. It will be governed by the IMI JU (Board, Executive Office and Scientific 
Committee)  and  by  2  additional  groups  (Member  States  Group  and  Stakeholder 
Forum). 

The IMI JU will manage the implementation of the research activities outlined in the 
Research  Agenda.  The  Executive  Office,  with  its  independent  staff,  will  be 
responsible  for  the  day-to-day  management,  including  the  call  and  evaluation 
process, grant agreements, etc. The Board, composed of the founding members, will 
have overall responsibility for the operations of the IMI JU, and decide on the annual 
implementation  of  the  research  activities  following  consultation  of  the  Scientific 
Committee. It will also be responsible for communication and co-ordination between 
IMI  and  Member  State  activities  (via  the  Member  States  Group).  A  Stakeholder 
Forum will be held annually to exchange views on the ongoing or planned research 
activities. 

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The  research  activities  will  be  conducted  through  collaborative  projects  between 
public and private organisations selected though open calls for proposals and a peer 
review  process.  Any  legal  entity  can  participate  in  such  projects  provided  the 
research is done in Member States or in the countries associated with FP7. 

The  research  activities  will  be  financed  through  contributions:  with  resources  'in 
kind' (personnel, equipment, consumables, etc.) from the EFPIA member companies 
and  with  financial  support  for  universities,  public  research  organisations,  SMEs, 
patient organisations etc. from the EC Contribution to IMI JU. All participating for-
profit organisations that are not considered as SMEs are expected to carry the costs 
of  participation  in  the  research  activities  and  will  not  receive  any  financial  support 
from the IMI JU. 

Grant agreements will govern the relationship between the selected consortia and the 
IMI JU. Such agreements will describe the implementation of the research activities, 
the appropriate financial arrangements and the rules relating to intellectual property 
rights on, the basis of the principles as set out in the Statutes of the IMI JU. 

The intellectual property policy for IMI JU designed to be beneficial to the different 
participants:  pharmaceutical  companies  want  to  have  access  to  new  methods  and 
results; SMEs want to have their new techniques tested by users (i.e. pharmaceutical 
companies);  universities  want  their  research  results  validated  and  recognised; 
clinicians want to have rapid access to results and data; patients want more efficient 
medicines  with  less  side  effects,  etc.  The  new  collaborative  partnership  of  IMI  JU 
will provide legal and operational framework for a win-win situation for all. It should 
ensure  the  maximum  utilization  of  research  results  and  data,  and  rapid  uptake  into 
industrial, clinical and regulatory practice. 

Through  revitalisation  of  research  in  the  pharmaceutical  sector,  Europe  should 
become an attractive and dynamic environment for private investment. 

Existing provisions in the area of the proposal 

No provisions exist today at a European level in this area. 

However,  the  FP6-funded  Integrated  Project  InnoMed  (involving  43  partners, 
including  18  large  pharmaceutical  companies)  serves  as  evidence  of  industry's 
willingness to cooperate with each other and with other stakeholders. 

Consistency with other Union policies and objectives 

The proposed Regulation is consistent with Community policies in research. It is also 
consistent with the renewed Lisbon strategy3 and the objectives of the EU to invest 
3% of its GDP in research and development by 2010, with two-thirds coming from 
the  private  sector,  as  decided  by  the  European  Council  in  Barcelona  2002.  The 
proposal is also consistent with the objectives of the previous G10 process4 on public 

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COM (2005) 24 
COM (2003) 383 

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health and EU Pharmaceuticals policies, the ongoing policy reflection process of the 
EU  Pharmaceutical  Forum,  and  to  the  recent  Aho  report  "Creating  an  Innovative 
Europe"5. 

The  proposed  initiative  is  part  of  a  broad  ambitious  Community  strategy  aimed  at 
tackling  the  innovation  gap  which  includes,  inter  alia,  the  proposal  to  establish  a 
European Institute of Technology. 

2. 

CONSULTATION AND IMPACT ASSESSMENT 

Consultation of interested parties and use of expertise 

Stakeholders (pharmaceutical industry, academia and clinical centres, SMEs, patient 
organisations, public authorities (including regulators)) have been widely consulted. 
The key forum for discussion with representatives of the Member States has been the 
IMI  Member  States  Contact  Group.  The  European  Medicines  Evaluation  Agency 
(EMEA)  has  contributed  through  consultations  of  their  scientific  committees.  In 
addition,  comments  have  been  received  following  the  publication  of  the  draft  SRA 
on the web and presentations at European and International level. 

Impact assessment  

The  proposed  Regulation  has  been  subject  to  a  Commission  Impact  Assessment, 
which is attached to the proposal. 

3. 

LEGAL FRAMEWORK OF THE PROPOSAL 

Summary of the proposed action 

The  present  proposal  concerns  setting  up  the  Innovative  Medicines  Initiative  Joint 
Undertaking (IMI JU) under Article 171 of the Treaty for the implementation of the 
Joint Technology Initiative on Innovative Medicines (IMI JTI). 

The  IMI  JU  should  be  considered  as  a  Community  body  and  be  established  for  a 
period ending on 31 December 2017. It will have its seat in Brussels, Belgium. 

It  will  be  founded  by  the  European  Community,  represented  by  the  EC,  and  the 
European  Federation  of  Pharmaceutical  Industries  and  Associations,  EFPIA.  The 
activities  of  the  IMI  JU  will  be  jointly  funded  by  its  founders.  The  European 
Community and EFPIA will contribute in equal parts to the running costs of the IMI 
JU. The research activities will be jointly funded through contributions by the EFPIA 
member companies with resources (personnel, equipment, consumables, etc.), and a 
matching contribution of the European Community. 

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Aho, Jozef Cornu, Luke Georghiou and Antoni Subriá: "Creating an Innovative Europe", Jan. 2006  

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The IMI JU will be open to new members, provided that they contribute with funds 
to achieve its objectives. 

The  European  Commission  will  be  represented  on  the  Board.  Any  decision  by  the 
Board shall require the positive vote of the European Commission. 

Legal basis 

The legal basis of the proposal is Article 171 of the Treaty establishing the European 
Community. 

Subsidiarity and Proportionality 

The  proposal  concerns  an  area  in  which  the  Community  does  not  have  exclusive 
competence, which is why the principle of subsidiarity applies. 

The  policy  objective  underlying  the  proposal  can  only  be  achieved  through 
Community action and this for the following reasons: 

(1) 

(2) 

(3) 

The  trans-national  nature  of  the  great  research  challenge  identified,  which 
requires  the  pooling  of  complementary  knowledge  and  financial  resources 
across sectors and borders. No single Member State, company or stakeholder 
can in and by itself resolve the problem. 

The co-ordination effort and the resources required are of such a large scale 
that they can only be credibly implemented at European level. 

In view of similar and competing initiatives being launched in other leading 
economies  (e.g.  Critical  Path  Initiative  in  the  US),  only  a  large-scale  action 
implemented at European level is sufficiently attractive for the globally acting 
pharmaceutical industry. 

In accordance with the principle of proportionality, the provisions of this regulation 
do not go beyond what is necessary to achieve its objectives. 

Choice of instrument 

The  proposed  Regulation  will  boost  the  public  and  private  investment  in  research 
aiming at improving the competitiveness of the European pharmaceutical sector. The 
Joint Undertaking option offers a potential leverage effect of Community funds with 
private  resources  that  cannot  be  achieved  with  the  traditional  instruments  of  the 
Framework Programme, i.e. each EUR 1 of Community funds will generate research 
investments worth at least EUR 2. 

Increased research investments will stimulate further investments in other industrial 
sectors. In addition, more public funds will be available for non profit stakeholders in 
the research activities, and the total research investment is expected to be higher than 
with the traditional EU collaborative research scheme. 

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4. 

BUDGETARY IMPLICATIONS 

The total budget of the IMI JU will be EUR 2 billion. 

The  maximum  contribution  from  the  European  Community  will  be  EUR  1  billion 
paid  from  the  budget  appropriation  allocated  to  the  Theme  'Health'  of  the  Specific 
Programme 'Cooperation' implementing FP7. 

The running costs  of the IMI JU  will  be financed in  equal parts  by  EFPIA  and the 
European Community. The running costs will not exceed 4% of the total budget for 
the period ending on 31.12.2017. 

The Research Activities will be jointly funded through a financial contribution of the 
European  Community,  and  contributions  by  the  research  based  pharmaceutical 
companies  that  are  full  members  of  EFPIA,  with  resources  in  kind  (such  as 
personnel, equipment, consumables, etc.) at least equal to the financial contribution 
of the European Community. 

5. 

ADDITIONAL INFORMATION 

Transitory period 

In order to facilitate the setting up of the IMI JU, the Founding Members, the EC and 
EFPIA, should take all necessary preparatory actions until the bodies responsible for 
its operations have been set up. 

Review 

The EC will present an annual report on the progress achieved by the IMI JU 

Discharge for the implementation of the budget of the IMI JU will be given by the 
European  Parliament,  upon  recommendation  of  the  Council,  taking  however  into 
account  the  specificities  resulting  from  the  nature  of  JTIs  as  public-private 
partnerships and in particular from the private sector contribution. 

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2007/0089 (CNS) 

Proposal for a 

COUNCIL REGULATION 

setting up the Innovative Medicines Initiative Joint Undertaking 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
171 and 172 thereof, 

Having regard to the proposal from the Commission6, 

Having regard to the opinion of the European Parliament7, 

Having regard to the opinion of the European Economic and Social Committee8, 

Whereas: 

(1) 

(2) 

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Decision  No  1982/2006/EC  of  the  European  Parliament  and  of  the  Council  of  18 
December  2006  concerning  the  Seventh  Framework  Programme  of  the  European 
Community  for  research,  technological  development  and  demonstration  activities 
(2007-2013)9  hereinafter  referred  to  as  the  "Seventh  Framework  Programme", 
provides  for  a  Community  contribution  for  the  establishment  up  of  long  term  public 
private  partnerships  in  the  form  of  Joint  Technology  Initiatives  to  be  implemented 
through  Joint  Undertakings  within  the  meaning  of  Article  171  of  the  Treaty.  These 
Joint Technology Initiatives result from the work of European Technology Platforms, 
already set up under the Sixth Framework Programme, and cover selected aspects of 
research in their field. They should combine private  sector investment and European 
public funding, including funding from the Seventh Framework Programme; 

Council  Decision  971/2006/EC  of  19  December  2006  concerning  the  specific 
programme  "Cooperation"  implementing  the  Seventh  Framework  Programme  of  the 
European  Community  for  research,  technological  development  and  demonstration 
activities  (2007  to  2013)10  (hereinafter  referred  as  the  "Specific  Programme 

OJ C, , p. . 
Opinion of the European Parliament of (…) 
Opinion delivered on (…) 
OJ L 412, 30.12.2006, p.1 
OJ L 400, 30.12.2006, p. 86. Corrected version in OJ L 54, 22.2.2007 p. 30. 

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(3) 

(4) 

(5) 

(6) 

(7) 

Cooperation"),  underlines  the  need  for  ambitious  pan-European  public  private 
partnerships  to  accelerate  the  development  of  major  technologies,  large  research 
actions at Community level including, in particular, Joint Technology Initiatives; 

The  Lisbon  Growth  and  Jobs  Agenda  underscores  the  need  to  develop  favourable 
conditions  for  investment  in  knowledge  and  innovation  in  Europe  to  boost 
competitiveness, growth and jobs in the Community, 

In  its  conclusions  of  20  and  21  March  2003,  of  22  September  2003  and  of  24 
September  2004,  the  Competitiveness  Council  highlighted  the  importance  of  further 
developing  actions  following  the  3%  Action  Plans11,  including  the  development  of 
new  initiatives  aimed  at  intensifying  co-operation  between  industry  and  the  public 
sector in funding research to enhance trans-national public-private links, 

In its conclusions of 4 December 2006 and of 19 February 2007, the Competitiveness 
Council  and  its  conclusions  of  9  March  2007  the  European  Council  invited  the 
Commission to present proposals for the setting up of Joint Technology Initiatives for 
such initiatives that have reached an appropriate stage of preparedness, 

The “European Federation of Pharmaceutical Industries and Associations” (hereinafter 
referred  to  as  "EFPIA")  took  the  lead  in  establishing  the  European  Technology 
Platform  on  "Innovative  Medicines"  under  the  Sixth  Framework  Programme.  They 
developed  a  Strategic  Research  Agenda,  based  on  an  extensive  consultation  with 
public and private stakeholders. The Strategic Research Agenda described the research 
bottlenecks in the drug development process and recommends the scientific direction 
for a Joint Technology Initiative on "Innovative Medicines”, 

The  Joint  Technology  Initiative  on  "Innovative  Medicines”  responds  to  the 
Commission  Communication  of  1  July  2003  "A  Stronger  European-based 
Pharmaceutical  Industry  for  the  Benefit  of  the  Patient  –  A  Call  for  Action"12  and  in 
particular  to  the  recommendation  regarding  access  to  innovative  medicines  to  secure 
the development of a competitive innovative-based industry. This Communication was 
a response to the Report "Stimulating Innovation and Improving the EU Science Base" 
adopted  on  7  May  2002  of  the  High  Level  Group  on  innovation  and  provision  of 
medicines  -  G10  Medicines.  This  Joint  Technology  Initiative  also  responds  to  the 
Commission  Communication  of  23  January  2002  on  “Life  Sciences  and 
Biotechnology – a strategy for Europe (2002)”13, 

(8) 

The Joint Technology Initiative on "Innovative Medicines” also replies to the need for 
action  as  identified  in  the  Report  "Creating  an  Innovative  Europe"  of  January  2006. 
This report identifies Pharmaceuticals as a key strategic area and it stresses the need 
for the Joint Technology Initiative on "Innovative Medicines" at European level. 

(9) 

The Joint Technology Initiative on "Innovative Medicines” should be a public-private 
partnership aiming at increasing investments in the biopharmaceutical sector in Europe 

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COM(2003) 226 final 
COM (2003)383 
COM(2002)27 

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in  the  Members  States  and  countries  associated  to  the  Seventh  Framework 
Programme. It should provide socio-economic benefits for European citizens, increase 
the competitiveness of Europe and help to establish Europe as the most attractive place 
for biopharmaceutical research and development. 

(10)  The objective of the Joint Technology Initiative on "Innovative Medicines” should be 
to  foster  collaboration  between  all  stakeholders  such  as  industry,  public  authorities 
(including  regulators),  organisations  of  patients,  academia  and  clinical  centres.  The 
Joint  Technology  Initiative  on  "Innovative  Medicines”  should  define  a  commonly 
agreed  research  agenda  (hereinafter  referred  to  as  "Research  Agenda"),  closely 
following  the  recommendations  of  the  Strategic  Research  Agenda  developed  by  the 
European Technology Platform on "Innovative Medicines". 

(11)  The  Joint  Technology  Initiative  on  "Innovative  Medicines”  should  propose  a 
coordinated  approach  to  overcome  identified  research  bottlenecks  in  the  drug 
development  process,  and  to  support  'pre-competitive  pharmaceutical  research  and 
development',  in  order  to  accelerate  the  development  of  safe  and  more  effective 
medicines for patients. In the present context 'pre-competitive pharmaceutical research 
and  development'  should  be  understood  as  research  on  the  tools  and  methodologies 
used in the drug development process. 

(12)  The  Joint  Technology  Initiative  on  "Innovative  Medicines”  should  deliver  new 
approaches,  methods  and  technologies,  improve  knowledge  management  of  research 
results and data, and support the training of professionals. To this end it is necessary to 
set  up  a  Joint  Undertaking  as  a  legal  entity  for  the  implementation  of  the  Joint 
Technology  Initiative  on  "Innovative  Medicines".  This  Joint  Undertaking 
is 
hereinafter referred to as the “IMI Joint Undertaking”. 

(13)  The  objective  of  the  IMI  Joint  Undertaking  should  be  achieved  though  support  of 
research  activities  by  pooling  resources  from  the  public  and  private  sectors.  To  that 
end, the IMI Joint Undertaking should be capable of organising competitive calls for 
proposals for supporting the research activities. Such research activities should respect 
fundamental ethical principles applicable in the Seventh Framework Programme. 

(14)  The  IMI  Joint  Undertaking  should  be  set  up  for  an  initial  period  ending  on  31 
December 2017 to ensure the appropriate management of research activities initiated 
but not concluded during the Seventh Framework Programme(2007-2013). 

(15)  The  IMI  Joint  Undertaking,  which  should  be  responsible  for  the  implementation  of 
Joint  Technology  Initiative  on  "Innovative  Medicines”,  and  discharge  commitments 
pursuant  to  international  agreements,  should  be  considered  as  an  international  body 
within the meaning of Article 22 of Directive 2004/17/EC of the European Parliament 
and  of  the  Council  of  31  March  2004  coordinating  the  procurement  procedures  of 
entities  operating  in  the  water,  energy,  transport  and  postal  service  sectors14,  and 
Article 15 of Directive 2004/18/EC of the European Parliament and of the Council of 

14 

OJ L 134, 30.4.2004, p.1. Directive as last amended by Directive 2006/97/EC (OJ L 363,20.12.2006, 
p.107) 

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31  March  2004  on  the  coordination  of  procedures  for  the  award  of  public  works 
contracts, public supply contracts and public service contracts15. 

(16)  The IMI Joint Undertaking should be a body set up by the Communities and discharge 
for the implementation of its budget should be given by the European Parliament16, on 
the  recommendation  of  the  Council,  taking  however  into  account  the  specificities 
resulting from the nature of JTIs as public-private partnerships and in particular from 
the private sector contribution to the budget. 

(17)  Founding members of the IMI Joint Undertaking should be the European Community 

and EFPIA. 

(18)  EFPIA  is  a  non-profit  organization  representing  the  research  based  pharmaceutical 
industry in Europe. The aim of EFPIA is to ensure and promote the technological and 
economic  development  of  the  pharmaceutical industry  in  Europe.  EFPIA  is  open  for 
full membership to national associations of research based pharmaceutical companies, 
as  well  as  directly  to  research  based  pharmaceutical  companies.  It  applies  general 
principles  of  openness  and  transparency  for  membership  ensuring  a  wide  industrial 
involvement. 

(19)  EFPIA was created in 1978 from a merger between two European organisations - GIIP 
(initially  created  under  French  law  in  1966)  representing  9  European  countries  and 
PIA  (created  under  Swiss  law  in  1967)  representing  EFTA  national  associations. 
EFPIA was set up under Swiss law with its permanent office in Brussels, Belgium. 

(20)  Switzerland  is  foreseen  to  become  a  country  associated  to  the  Seventh  Framework 
Programme via the signature of an Association Agreement with the Community. 

(21)  The IMI Joint Undertaking should be open to new members. 

(22)  The rules for organisation and operation of the IMI Joint Undertaking should be laid 

down in the Statutes of the IMI Joint Undertaking. 

(23)  A letter of commitment concerning the Statutes of the IMI Joint Undertaking has been 
signed  by  EFPIA  and  its  research  based  pharmaceutical  companies  that  are  full 
members of EFPIA, 

(24)  The research activities should be covered by funding from the Community and at least 
on an equal level by resources from the research based pharmaceutical companies that 
are full members of EFPIA. 

(25)  The running costs of the IMI Joint Undertaking should be covered by equal amounts 

by EFPIA and the Community. 

15 
16 

OJ L 134, 30.4.2004, p.1. Directive as last amended by Directive 2006/97/EC 
Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable 
to  the  budget  of  the  European  Communities,  OJ  L  357,  31.12.2002  p.  72;  corrigendum  in  OJ  L  2, 
7.12003, p. 39 

EN 

12 

   EN 

 
                                                 
(26)  The  research  based  pharmaceutical  companies  that  are  full  members  of  EFPIA 
activities shall not be eligible to receive support from the IMI Joint Undertaking. 

(27)  The  IMI  Joint  Undertaking  should  have,  subject  to  prior  consultation  with  the 
Commission, a distinct Financial Regulation based on the principles of the framework 
financial regulation17 which takes into account its specific operating needs arising, in 
particular,  from  the  need  to  combine  Community  and  private  funding  to  support 
research and development activities in an efficient and timely manner. 

(28)  The need to ensure stable employment conditions and equal treatment of staff, and in 
order to attract specialised scientific and technical staff of the highest calibre, requires 
the application of the Staff Regulations of Officials of the European Communities and 
the Conditions of Employment of Other Servants of the European Communities, ("the 
Staff Regulation") to all staff recruited by the IMI Joint Undertaking. 

(29)  Taking  into  account  that  the  IMI  Joint  Undertaking  is  not  designed  to  fulfil  an 
economic purpose and is responsible for managing the Joint Technology Initiative on 
"Innovative  Medicines”,  it  is  necessary  for  the  performance  of  its  tasks  that  the 
Protocol  on  the  Privileges  and  Immunities  of  the  European  Communities  of  8  April 
1965 should apply to the IMI Joint Undertaking and its staff. 

(30)  As  a  body  possessing  legal  personality,  the  IMI  Joint  Undertaking  should  be 
accountable for its actions. As regards the resolution of disputes in contractual matters, 
it  should  be  possible  that  the  contracts  concluded  by  the  Joint  Undertaking  provide 
that the Court of Justice of the European Communities has jurisdiction. 

(31)  Appropriate  measures  should  be  taken  to  prevent  irregularities  and  fraud  and  the 
necessary steps should be taken to recover funds lost, wrongly paid or incorrectly used 
in  accordance  with  Council  Regulation  (EC,  Euratom)  No  2988/95  of  18  December 
1995  on  the  protection  of  the  European  Communities  financial  interests18,  Council 
Regulation (EC, Euratom) No 2185/96 of 11 November 1996 concerning on-the-spot 
checks and inspections carried out by the Commission in order to protect the European 
Communities’  financial  interests  against  fraud  and  other  irregularities19,  and  the 
Regulation  (EC)  No1073/1999  of  the  European  Parliament  and  of  the  Council 
concerning investigations concluded by the European Anti-Fraud Office (OLAF)20. 

(32) 

In  order  to  facilitate  the  setting  up  of  the  IMI  Joint  Undertaking,  the  founding 
members should take all necessary preparatory actions until the bodies responsible for 
its operation has been set up, 

17 

18 
19 
20 

Commission  Regulation  (EC,  Euratom)  No2343/2002  of  23  December  2002  on  the  framework 
Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 
1605/2002  on  the  Financial  Regulation  applicable  to  the  budget  of  the  European  Communities,  OJ  L 
357, 31.12.2002 p. 72; corrigendum in OJ L 2, 7.12003, p. 39 
OJ L 312,23.12.1995, p.1 
OJ L 295,15.11.1996, p.2 
OJ L 136,31.05.1999, p.1 

EN 

13 

   EN 

 
                                                 
(33)  The  IMI  Joint  Undertaking  should  be  established  in  Brussels,  Belgium.  A  host 
agreement  should  be  concluded  between  the  IMI  Joint  Undertaking  and  Belgium 
concerning office accommodation, privileges and immunities and other support to be 
provided by Belgium to the IMI Joint Undertaking. 

(34)  Since the objective of the action to be taken, namely the establishment of the IMI Joint 
Undertaking, cannot be sufficiently achieved by the Member States due to the trans-
national nature of the great research challenge identified, which requires the pooling of 
complementary knowledge and financial resources across the sectors and borders and 
can therefore be better achieved at Community level by reason of co-ordination effort 
and the resources required are such large scale, be better achieved at Community level, 
the Community may adopt measures, in accordance with the principle of subsidiarity 
as  set  our  in  Article  5  of  the  Treaty.  In  accordance  with  the  principle  of 
proportionality, as set out in that Article, this Regulation does not go beyond what is 
necessary in order to achieve this objective.  

HAS ADOPTED THIS REGULATION: 

Article 1 
Establishment of a Joint Undertaking 

1. 

For the implementation of the Joint Technology Initiative on Innovative Medicines, a 
Joint  Undertaking  is  hereby  set  up  for  a  period  ending  on  31  December  2017 
(hereinafter referred to as "IMI Joint Undertaking"). This period may be extended by 
the Council. 

2. 

The seat of the IMI Joint Undertaking shall be located in Brussels, Belgium. 

Article 2 
Legal status 

1. 

2. 

The IMI Joint Undertaking shall have legal personality. In the Member States, it shall 
enjoy the most extensive legal capacity accorded to legal persons under the laws of 
those  States.  It  may,  in  particular,  acquire  or  dispose  of  movable  and  immovable 
property and be a party to legal proceedings. 

The  IMI  Joint  Undertaking  shall  be  considered  as  an  international  body  within  the 
meaning of point c of Article 22 of Directive 2004/17/EC and of point c of Article 15 
of Directive 2004/18/EC. 

Article 3 
Objectives 

The IMI Joint Undertaking shall contribute to the implementation of the Seventh Framework 
Programme  and  the  Theme  'Health'  of  the  Specific  Programme  'Cooperation'  implementing 
the  Seventh  Framework  Programme  (2007-2013)  of  the  European  Community  for  research, 
technology development and demonstration activities, and, in particular to: 

EN 

14 

   EN 

 
(a) 

(b) 

(c) 

(d) 

(e) 

support  'pre-competitive  pharmaceutical  research  and  development'  in  the 
Member States and countries associated to the Seventh Framework Programme 
via a coordinated approach to overcome the identified research bottlenecks in 
the drug development process; 

support the implementation of the research priorities as set out by the Research 
Agenda  of  the  Joint  Technology  Initiative  on  "Innovative  Medicines" 
(hereinafter  referred  to  as  "Research  Activities"),  notably  by  awarding  grants 
following competitive calls for proposals; 

be a public-private partnership aiming at increasing the research investment in 
the biopharmaceutical sector in the Members States and countries associated to 
the  Seventh  Framework  Programme  by  pooling  resources  and  fostering 
collaboration between the public and private sectors; 

conclude service and supply contracts necessary for the operations of the IMI 
Joint Undertaking; 

ensure  the  efficiency  and  durability  of  the  Joint  Technology  Initiative  on 
"Innovative Medicines". 

Article 4 
Members 

1. 

The  founding  members  of  the  IMI  Joint  Undertaking,  hereinafter  referred  to  as 
"Founding Members", shall be: 

(a) 

the European Community, represented by the Commission; 

(b) 

the  European  Federation  of  Pharmaceutical  Industries  and  Associations 
(hereinafter referred to as “EFPIA”).  

2. 

Provided that they contribute to the funding to achieve the objectives of the IMI Joint 
Undertaking  as  provided  for  in  Article  3,  the  following  may  apply  to  become  a 
member of the IMI Joint Undertaking: 

(a)  Member  States  and  countries  associated 

to 

the  Seventh  Framework 

Programme; 

(b) 

Any legal entity supporting directly or indirectly research and development in 
the  Members  States  and  countries  associated  to  the  Seventh  Framework 
Programme. 

3. 

The Founding Members and new members as referred to in paragraphs 1 and 2 are 
hereinafter referred to as "Members". 

The Statutes of the IMI Joint Undertaking are set out in the Annex. 

Article 5 
Statutes 

EN 

15 

   EN 

 
Article 6 
Sources of financing 

1. 

2. 

3. 

4. 

5. 

The  IMI  Joint  Undertaking  and  its  activities  shall  be  jointly  funded  through 
contributions from its Members. 

The  running  costs  of  the  IMI  Joint  Undertaking  shall  be  financed  by  its  Members. 
The Community and EFPIA shall contribute in equal part to such running costs.  

The  operational  costs,  hereinafter  referred  to  as  the  Research  Activities,  shall  be 
jointly  funded  through  financial  contribution  of  the  Community  and  voluntary 
contributions by the research based pharmaceutical companies that are full members 
of EFPIA with resources at least equal to the Community contribution. 

The  maximum  Community  contribution  to  the  IMI  Joint  Undertaking  covering 
running costs and Research Activities shall be EUR 1 billion (one billion euros) paid 
from  the  budget  appropriation  allocated  to  the  Theme  'Health'  of  the  Specific 
Programme  'Cooperation'  implementing  the  Seventh  Framework  Programme  for 
research,  technical  development  and  demonstration  (2007-2013)  according  to  the 
provisions  of  Article  54(2)(b)  of  the  Council  Regulation  (EC,  Euratom)  No 
1605/2002  on  the  Financial  Regulation  applicable  to  the  general  budget  of  the 
European Communities. 

The arrangements  for the  Community financial contribution shall be established  by 
means  of  a  general  agreement  and  annual  financial  agreements  to  be  concluded 
between  the  Commission,  on  behalf  of  the  Community,  and  the  IMI  Joint 
Undertaking. 

Article 7 
Eligibility for funding 

The  Community  contribution  to  the  IMI  Joint  Undertaking  for  the  funding  of  the  Research 
Activities  shall  be  granted  following  competitive  calls  for  proposals.  The  following  legal 
entities shall be eligible for such funding: 

(a) 

micro, small and medium-sized enterprises within the meaning of Commission 
Recommendation 2003/361/EC21; 

(b) 

legal entities established as non-profit public bodies under national law; 

(c) 

intergovernmental  organisations,  which  have 
legal  personality  under 
international  public  law,  as  well  as  any  specialised  agencies  set  up  by  such 
intergovernmental organisations; 

(d) 

legal entities established under Community law; 

21 

OJ L 124, 20.5.2003, p. 36 

EN 

16 

   EN 

 
                                                 
(e) 

legal  entities  established  as  non-profit  organisations  which  carry  out  research 
or technological development as one of their main objectives; 

(f) 

secondary and higher education establishments; 

(g) 

qualified non-profit patients organisations. 

Article 8 
Financial Regulation 

1. 

The IMI Joint Undertaking's Financial Regulation shall be based on the principles of 
the Framework Financial Regulation22. It may depart from the Framework Financial 
Regulation  where  the  specific  operating  needs  of  the  IMI  Joint  Undertaking  so 
require and subject to prior consultation with the Commission.  

2. 

The IMI Joint Undertaking shall have its own internal audit capability. 

Article 9 
Staff 

1. 

2. 

3. 

The Staff Regulations of Officials of the European Communities, the Conditions of 
Employment of Other Servants of the European Communities and the rules adopted 
jointly  by  the  European  Community  institutions  for  the  purpose  of  applying  these 
Staff Regulations and Conditions of Employment shall apply to the staff of the IMI 
Joint undertaking and its Executive Director. 

In respect of its staff, the IMI Joint Undertaking shall exercise the powers conferred 
on  the  appointing  authority  by  the  Staff  Regulations  of  Officials  of  the  European 
Communities  and  on  the  authority  empowered  to  conclude  contracts  by  the 
Conditions of Employment of Other Servants of the European Communities. 

The  IMI  Joint  Undertaking  shall,  in  agreement  with  the  Commission,  adopt  the 
necessary implementing measures, in accordance with arrangements provided for in 
article 110 of the Staff Regulations of Officials of the European Communities, and 
the Conditions of Employment of Other Servants of the European Communities. 

Article 10 
Privileges and Immunities 

The Protocol on the Privileges and Immunities of the European Communities shall apply to 
the IMI Joint Undertaking and its staff. 

22 

OJ L 357, 31.12.2002 p. 72; corrigendum in OJ L 2, 7.12003, p. 39 

EN 

17 

   EN 

 
                                                 
1. 

2. 

3. 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

Article 11 
Liability 

The  contractual  liability  of  the  IMI  Joint  Undertaking  shall  be  governed  by  the 
relevant  contractual  provisions  and  by  the  law  applicable  to  the  agreement  or 
contract in question. 

In  the  case  of  non-contractual  liability,  the  IMI  Joint  Undertaking  shall,  in 
accordance  with  the  general  principles  common  to  the  laws  of  the  Member  States, 
make good any damage caused by its staff in the performance of their duties. 

Any  payment  by the  IMI  Joint  Undertaking in respect of the liability referred to in 
paragraphs 1 and 2 and the costs and expenses incurred in connection therewith shall 
be considered as expenditure of the IMI Joint Undertaking and shall be covered by 
the resources of the IMI Joint Undertaking. 

Article 12 
Jurisdiction of the Court of Justice and applicable law 

The  Court  of  Justice  shall  have  jurisdiction  in  any  dispute  between  the  Members 
which relates to the subject matter of this Regulation and the Statutes referred to in 
Article 5 of this Regulation. 

The  Court  of  Justice  shall  have  jurisdiction  to  give  judgment  pursuant  to  any 
arbitration  clause  contained  in  agreement  and  contract  concluded  by  the  IMI  Joint 
Undertaking. 

The Court of Justice shall have jurisdiction in actions brought against the IMI Joint 
Undertaking,  including  decisions  of  its  Board,  under  the  conditions  provided  for  in 
Articles 230 and 232 of the Treaty. 

The Court of Justice shall have jurisdiction in disputes relating to compensation for 
damage caused by the staff of the IMI Joint Undertaking in the performance of their 
duties. 

For any matter not covered by this Regulation or by other acts of Community law, 
the  law  of  the  State  where  the  seat  of  the  IMI  Joint  Undertaking  is  located  shall 
apply. 

Article 13 
Report, evaluation and discharge 

The  Commission  shall  present  to  the  European  Parliament  and  to  the  Council  an 
annual report on the progress achieved by the IMI Joint Undertaking. 

Two years after the establishment of the IMI Joint Undertaking, but in any case no 
later than 2010, the Commission shall conduct an interim evaluation of the IMI Joint 
Undertaking with the assistance of independent experts. This evaluation shall cover 
the  quality  and  efficiency  of  the  IMI  Joint  Undertaking  and  progress  towards  the 

EN 

18 

   EN 

 
3. 

4. 

1. 

2. 

3. 

4. 

5. 

objectives  set.  The  Commission  shall  communicate  the  conclusions  thereof, 
accompanied by its observations to the European Parliament and to the Council. 

At the end of 2017, the Commission shall conduct a final evaluation of the IMI Joint 
Undertaking  with  the  assistance  of  independent  experts.  The  results  of  the  final 
evaluation shall be presented the European Parliament and to the Council. 

Discharge for the implementation of the budget of the IMI Joint Undertaking shall be 
given  by  the  European  Parliament,  upon  recommendation  of  the  Council,  in 
accordance  with  a  procedure  provided  for  by  the  Financial  Regulation  of  the  IMI 
Joint Undertaking. 

Article 14 
Protection of the financial interests of the Members and anti-fraud measures 

The IMI Joint Undertaking shall ensure that the financial interests of its Members are 
adequately protected by carrying out or by allowing the carrying out of appropriate 
internal and external controls. 

In  case  of  irregularities  committed  by  the  IMI  Joint  Undertaking  or  its  staff,  the 
Members  shall  reserve  the  right  to  recover  amount  unduly  spent  or  to  reduce  or 
suspend any subsequent contribution to the IMI Joint Undertaking. 

For  the  purposes  of  combating  fraud,  corruption  and  other  illegal  acts,  Regulation 
(EC) No 1073/1999 shall apply. 

The  Commission  and/or  the  Court  of  Auditors  may,  if  necessary,  carry  out  on-the-
spot  checks  among  the  recipients  of  the  IMI  Joint  Undertaking's  funding  and  the 
agents  responsible  for  allocating  it.  To  that  end,  the  IMI  Joint  Undertaking  shall 
ensure that grant agreements and contracts provide for the right of the Commission 
and/or the Court of Auditors to carry out, on behalf of the IMI Joint Undertaking, the 
appropriate  controls  and,  in  the  event  of  the  detection  of  irregularities,  to  impose 
dissuasive and proportionate penalties. 

The  European  Anti-Fraud  Office  (OLAF)  set  up  by  Commission  Decision 
1999/352/EC,  ECSC,  Euratom  shall  enjoy  the  same  powers  in  respect  of  the  Joint 
Undertaking and its staff as it enjoys in respect of Commission departments. As soon 
as  the  Joint  Undertaking  is  established  it  shall  accede  to  the  Interinstitutional 
Agreement of 25 May 1999 between the European Parliament, the Council and the 
Commission regarding internal investigations by OLAF. The Joint Undertaking shall 
approve that accession and adopt the necessary measures needed to facilitate internal 
investigations conducted by OLAF. 

Article 15 
Confidentiality 

The IMI Joint Undertaking shall ensure the protection of sensitive information, disclosure of 
which could damage the interests of its Members. 

EN 

19 

   EN 

 
Article 16 
Intellectual property 

The IMI Joint Undertaking shall adopt rules governing the use and dissemination of research 
results  which  ensure  that,  where  appropriate,  intellectual  property  generated  in  Research 
Activities  under  this  Regulation  is  protected,  and  that  research  results  are  used  and 
disseminated. 

Article 17 
Preparatory actions 

The  Founding  Members  shall  be  responsible  for  carrying  out  all  activities  relating  to  the 
establishment of the IMI Joint Undertaking until the bodies responsible for its operation have 
been set up. 

Article 18 
Support from the host State 

A  host  agreement  shall  be  concluded  between  the  IMI  Joint  Undertaking  and  Belgium 
concerning  office  accommodation,  privileges  and  immunities  and  other  support  to  be 
provided by Belgium to the IMI Joint Undertaking. 

Article 19 
Entry into force 

This Regulation shall enter into force on the third day of its publication in the Official Journal 
of the European Union. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the Council 
The President 

EN 

20 

   EN 

 
 
 
1. 

2. 

3. 

4. 

5. 

1. 

ANNEX  

STATUTES OF THE INNOVATIVE MEDICINES INITIATIVE JOINT 
UNDERTAKING 

Article 1 
Name, location, duration and legal personality 

The  name  of  the  Joint  Undertaking  shall  be:  “Innovative  Medicines  Initiative  Joint 
Undertaking", hereinafter referred to as IMI Joint Undertaking. 

Its seat shall be located in Brussels, Belgium. 

The  IMI  Joint  Undertaking  shall  be  established  as  from  the  publication  of  these 
Statutes in the Official Journal of the European Union for an initial period ending on 
31 December 2017. 

The  initial  period  may  be  extended  by  amending  these  Statutes  in  accordance  with 
the provisions of Article 21, taking into account the progress made towards achieving 
the objectives of the IMI Joint Undertaking and provided that financial sustainability 
is ensured. 

The IMI Joint Undertaking shall have legal personality. In all the Member States, it 
shall  enjoy  the  most  extensive  legal  capacity  accorded  to  legal  persons  under  the 
laws  of  those  States.  It  may,  in  particular,  acquire  or  dispose  of  movable  and 
immovable property and be a party to legal proceedings. 

Article 2 
Objectives and main tasks 

The  objectives  of  the  IMI  Joint  Undertaking  shall  be  to  contribute  to  the 
implementation of the Seventh Framework Programme of the European Community 
for  research,  technology  development  and  demonstration  activities  (2007-2013), 
hereinafter  referred  to  as  the  'Seventh  Framework  Programme',  and  the  Theme 
'Health'  of  the  Specific  Programme  'Cooperation'  implementing  the  Seventh 
Framework  Programme  (2007-2013)  of  the  European  Community  for  research, 
technology development and demonstration activities, and, in particular: 

(a) 

(b) 

to  support  'pre-competitive  pharmaceutical  research  and  development',  i.e. 
research on the tools and methodologies used in the drug development process 
in  the  Member  States  and  countries  associated  to  the  Seventh  Framework 
Programme  via  a  coordinated  approach  to  overcome  the  identified  research 
bottlenecks in the drug development process; 

to  support  the  implementation  of  the  research  priorities  as  set  out  by  the 
Research  Agenda  of 
the  Joint  Technology  Initiative  on  "Innovative 
Medicines",  hereinafter  referred  to  as  "Research  Activities",  notably  by 
awarding grants following competitive calls for proposals; 

EN 

21 

   EN 

 
(c) 

(d) 

(e) 

to be a public-private partnership aiming at increasing the research investment 
in the biopharmaceutical sector in the Member States and countries associated 
to  the  Seventh  Framework  Programme  by  pooling  resources  and  fostering 
collaboration between the public and private sectors; 

to  conclude  service  and  supply  contracts  necessary  for  the  operations  of  the 
IMI Joint Undertaking; 

to  ensure  the  efficiency  and  durability  of  the  Joint  Technology  Initiative  on 
"Innovative Medicines". 

2. 

The main tasks of the IMI Joint Undertaking shall be the following: 

(a) 

(b) 

(c) 

to  ensure  the  establishment  and  sustainable  management  of  the  Joint 
Technology Initiative on "Innovative Medicines"; 

to manage the annual implementation plan referred to in Article 13 via calls for 
project proposals open to legal entities worldwide provided that their Research 
Activities will be prospective and carried out in a Members State or a country 
associated  to  the  Seventh  Framework  Programme  unless  otherwise  agreed  on 
an exceptional basis; 

to  make  any  necessary  adjustments  to  the  Research  Agenda  of  the  Joint 
Technology  Initiative  on  "Innovative  Medicines"  in  light  of  scientific 
developments occurring during its implementation; 

(d) 

to mobilise the public and private sector resources needed; 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

to  establish  and  develop  close  and  long-term  co-operation  between  the 
Community,  industry  and  the  other  stakeholders  such  as  regulatory  bodies, 
patients organisations, academia and clinical centres; 

to facilitate co-ordination with national and international activities in this area; 

to manage communication and dissemination of the activities of the IMI Joint 
Undertaking subject to confidentiality obligations; 

to  communicate  and  interact  with  the  Member  States  and  the  countries 
associated  to  the  Seventh  Framework  Programme  via  a  group  specifically 
established  for  this  purpose,  hereafter  referred  to  as  'IMI  Member  States 
Group'; 

to  organise  an  annual  meeting,  hereafter  referred  to  as  a  Stakeholder  Forum, 
with  interest  groups  to  ensure  openness  and  transparency  of  the  Research 
Activities of the IMI Joint Undertaking with its stakeholders; 

to  notify  legal  entities  that  have  concluded  a  grant  agreement,  hereinafter 
referred to as Grant Agreement, with the IMI Joint Undertaking of the potential 
borrowing opportunities from the European Investment Bank, in particular the 
Risk  Sharing  Finance  Facility  set  up  under 
the  Seventh  Framework 
Programme. 

EN 

22 

   EN 

 
(k) 

to publish information on the projects, including the name of the participants, 
and the amount of the financial contribution of the IMI Joint Undertaking. 

Article 3 
Members 

1. 

The  founding  members  of  the  IMI  Joint  Undertaking,  hereinafter  referred  to  as 
"Founding Members", shall be: 

(a) 

the European Community, represented by the Commission; 

(b) 

the  European  Federation  of  Pharmaceutical  Industries  and  Associations, 
hereinafter  referred  to  as  “EFPIA”,  a  non-profit  association  registered  under 
Swiss  law  (registration  number  4749)  with  its  permanent  office  in  Brussels, 
Belgium.  EFPIA  operates  as  a 
the 
Pharmaceutical Industry in Europe. 

representative  organisation  of 

Provided that they contribute to the funding to achieve the objectives of the IMI Joint 
Undertaking  as  described  in  Article  2(1),  the  following  may  apply  to  become  a 
Member of the IMI Joint Undertaking: 

(a)  Member  States  and  countries  associated 

to 

the  Seventh  Framework 

Programme; 

(b) 

any legal entity supporting directly or indirectly research and development in a 
Member State or a country associated to the Seventh Framework Programme. 

The  Founding  Members  and  new  members  referred  to  in  paragraphs  1  and  2  are 
hereinafter referred to as "Members". 

Any application for new membership shall be addressed to the Board in accordance 
with Article 5.  

Any  Member  may  terminate  its  membership  of  the  IMI  Joint  Undertaking.  The 
termination  shall  become  effective  and  irrevocable  six  months  after  notification  to 
the  other  Members  following  which  the  former  Member  shall  be  discharged  from 
any obligations others than those approved by the IMI Joint Undertaking prior to the 
membership termination. 

2. 

3. 

4. 

5. 

Article 4 
Bodies 

The bodies IMI Joint Undertaking shall be the Board, the Executive Office and the Scientific 
Committee. 

1. 

Composition and decision making process of the Board shall be the following: 

Article 5 
 Board 

EN 

23 

   EN 

 
(a) 

the Founding Members shall have five votes each in the Board; 

(b) 

the  voting  right  of  any  new  Member  shall  be  determined  in  proportion  to  its 
contribution  towards  the  total  contributions  to  the  activities  of  the  IMI  Joint 
Undertaking; 

(c) 

the vote of each Member shall be indivisible;  

(d) 

(e) 

(f) 

(g) 

the  Board  shall  make  decisions  by  a  three-quarters  majority  and  shall  require 
the positive vote by the Founding Members; 

each  Member  of  the  IMI  Joint  Undertaking  shall  be  represented  in  the  Board 
by a maximum of five representatives;  

the  chairperson  of  the  Board  shall  be  a  representative  of  the  Founding 
Members, serving on a rotating basis; 

the  representatives  of  the  Members  shall  not  be  personally  liable  for  actions 
undertaken in their capacity as representatives on the Board. 

2. 

The role and tasks of the Board shall be the following; 

(a) 

(b) 

the Board shall have overall responsibility for the operations of the IMI Joint 
Undertaking; 

the  Board  shall  oversee  the  implementation  of  the  IMI  Joint  Undertaking 
activities; 

(c) 

the Board shall in particular: 

– 

– 

– 

– 

– 

– 

assess  the  application(s)  for  any  new  membership  to  the  IMI  Joint 
Undertaking.  Any  application  of  a  Member  State  or  a  country 
associated  to  the  Seventh  Framework  Programme  or  an  international 
organisation  shall  be  subject  to  approval  by  the  Council.  Any  other 
applications shall be decided by the Board; 

decide  on  the  termination  of  the  membership  in  the  IMI  Joint 
Undertaking  of  any  Member  which  does  not  fulfil  its  obligations 
notwithstanding the provisions of the Treaty ensuring compliance with 
Community law; 

approve the annual implementation plan proposal and the corresponding 
expenditure estimates; 

approve  the  annual  budget  proposal,  including  the  staff  establishment 
plan; 

approve  the  annual  activity  report,  including  the  corresponding 
expenditure; 

approve the annual accounts and the balance-sheet; 

EN 

24 

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– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

arrange for the establishment of the internal audit capabilities of the IMI 
Joint undertaking; 

approve  any  change  to  the  Research  Agenda  as  recommended  by  the 
Scientific Committee; 

approve the guidelines on evaluation and selection of project proposals 
as proposed by the Executive Office; 

approve the list of selected project proposals; 

appoint  the  Executive  Director,  provide  guidance  and  direction  to  the 
Executive Director, monitor the Executive Director’s performance and, 
if necessary, replace the Executive Director; 

approve  the  organisational  structure  of  the  Executive  Office  based  on 
recommendations of the Executive Director; 

approve  the  financial  regulation  of  the  IMI  Joint  Undertaking  in 
accordance with Article 11; 

approve the internal rules and procedures of the IMI Joint Undertaking, 
including the Intellectual Property Policy; 

approve the staff regulation of the IMI Joint Undertaking in accordance 
with Article 14;  

adopt the Board procedures; 

agree on proposed amendments of the IMI Joint Undertaking’s Statutes 
in accordance with Article 21; 

assign any task which is not specifically allocated to one of the bodies 
of the IMI Joint Undertaking. 

3. 

The Board shall meet at least twice a year. Extraordinary meetings shall be convened 
at the request of one of the Members or at the request of the Executive Director. The 
meetings shall normally take place at the Head Office of the IMI Joint Undertaking. 

(a) 

(b) 

(c) 

Unless  otherwise  decided  in  particular  cases,  the  Executive  Director  shall 
participate in the meetings. 

The chairman of the Scientific Committee shall participate by invitation of the 
Board, as relevant to the agenda. 

Observers and/or other experts may be invited by the Board to attend meetings 
as and when relevant to the agenda. 

EN 

25 

   EN 

 
Article 6 
Executive Office 

1. 

2. 

The  Executive  Office  shall  be  composed  of  an  Executive  Director  and  supporting 
staff. 

The tasks of the executive office are the following: 

(a) 

(b) 

(c) 

The Executive Office shall be in charge of the day-to-day management of the 
IMI Joint Undertaking; 

The Executive Office shall be responsible for the operational aspects of the IMI 
Joint Undertaking; 

The  Executive  Office  shall  be  responsible  for  the  communication  activities 
related to the IMI Joint Undertaking; 

(d) 

The Executive Office shall manage appropriately the public and private funds; 

(e) 

The Executive Office shall in particular: 

– 

– 

– 

– 

– 

– 

– 

– 

– 

recommend  to  the  Board,  arrangements  and  guidelines  for  evaluation 
and  selection  of  the  project  proposals  for  approval.  These  guidelines 
shall  include  procedures,  composition,  duties  of  the  peer  review 
committees  that  evaluate  the  project  proposals  and  the  rules  for 
dissemination of research results; 

manage the launch of the calls for project proposals, the evaluation and 
selection of the project proposals, the negotiation of the selected project 
proposals, the follow-up of the project proposals and the administration 
of  the  grants,  including  the  co-ordination  of  the  funded  research 
activities; 

be  in  charge  of  the  establishment  and  management  of  the  appropriate 
accounting system; 

provide  the  Board  and  the  Scientific  Committee  with  relevant 
documentation and logistical support; 

prepare the annual implementation plan proposal and the corresponding 
expenditure estimates; 

prepare  the  annual  budget  proposal,  including  the  staff  establishment 
plan; 

prepare 
expenditure; 

the  annual  activity  report, 

including 

the  corresponding 

prepare the annual accounts and the balance-sheet; 

prepare any other information that may be requested by the Board; 

EN 

26 

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– 

manage invitations for tenders for IMI Joint Undertaking goods/services 
requirements  according  to  the  financial  regulation  of  the  IMI  Joint 
Undertaking;  

– 

perform tasks entrusted or delegated to it by the Board. 

The  Executive  Director  shall  be  the  chief  executive  responsible  for  the  day-to-day 
management  of  the  IMI  Joint  Undertaking  in  accordance  with  the  decisions  of  the 
Board.  In  that  context,  he/she  shall  regularly  inform  as  well  as  respond  to  any 
specific  ad  hoc  requests  for  information  from  the  Board  and  the  Scientific 
Committee. 

The  Executive  Director  shall  be  the  chief  executive  responsible  for  the  day-to-day 
management  of  the  IMI  Joint  Undertaking  and  be  its  legal  representative.  He/she 
shall perform his/her tasks with independence, and shall be accountable to the Board. 

The  Executive  Director  shall  be  appointed  by  the  Board,  from  a  list  of  candidates 
proposed by the Commission, for a period of up to three years. After an evaluation of 
the  Director's  performance,  the  Board  may  extend  the  term  of  office  once  for  a 
further period of not more than four years. 

The  Executive  Director  shall  direct  the  activities  of  the  IMI  Joint  Undertaking  in 
accordance  with  the  decisions  of  the  Board.  In  that  context,  he/she  shall  regularly 
inform  as  well  as  respond  to  any  specific ad  hoc  requests  for  information  from  the 
Board and the Scientific Committee. 

3. 

4. 

5. 

6. 

7. 

The Executive Director shall in particular:  

(a) 

(b) 

(c) 

submit  to  the  Board  the  annual  implementation  plan  proposal  and  the 
corresponding expenditure estimates;  

submit  to  the  Board  the  annual  budget  proposal,  including  the  staff 
establishment plan; 

submit  to  the  Board  the  annual  activity  report,  including  the  corresponding 
expenditure;  

(d) 

submit to the Board the annual accounts and the balance-sheet; 

(e) 

submit to the Board any change to the Research Agenda as recommended by 
the Scientific Committee; 

(f) 

supervise the management of the calls for project proposals; 

(g) 

submit to the Board his/her proposal(s) concerning the organisation structure of 
the  Executive  Office  and  organise,  direct  and  supervise  the  staff  of  the  IMI 
Joint Undertaking; 

(h) 

convene meetings of the Board;  

EN 

27 

   EN 

 
(i) 

(j) 

(k) 

call  the  annual  meeting  of  the  Stakeholder  Forum,  to  ensure  openness  and 
transparency  of  the  activities  of  the  IMI  Joint  Undertaking  with  its 
stakeholders; 

attend  as  appropriate  the  meetings  of  the  Board,  of  the  Scientific  Committee 
and of the Stakeholder Forum as observer;  

if appropriate, set up scientific ad hoc/subsidiary bodies/committees decided by 
the Board and gather experts scientific advice; 

(l) 

provide to the Board any other information that may be requested; 

(m) 

be responsible for risk assessment and risk management; 

(n) 

(o) 

propose to the Board any insurance that it may be necessary for the IMI Joint 
Undertaking to take out in order to meet its obligations; 

be responsible for concluding Grant Agreements for the implementation of the 
Research  Activities,  and  service  and  supply  contracts  necessary  for  the 
operations of the IMI Joint Undertaking as referred to in Article 18. 

Article 7 
Scientific Committee 

1. 

2. 

3. 

4. 

5. 

6. 

The  Scientific  Committee  is  an  advisory  body  to  the  Board  and  it  shall  conduct  its 
activities in close liaison and with the support of the Executive Office. 

The Scientific Committee shall consist of no more than 15 members. 

Such  members  shall  reflect  a  balanced  representation  of  expertise  from  academia, 
patient  organisations,  industry  and  regulatory  bodies.  Collectively,  the  Scientific 
Committee  members  shall  have  the  scientific  competencies  and  expertise  covering 
the  complete  drug  development  process  needed  to  make  strategic  science-based 
recommendations regarding the IMI Joint Undertaking. 

The  Board  shall  establish  the  specific  criteria  and  selection  process  for  the 
composition of the Scientific Committee and appoint candidates subject to selection 
by the IMI Member States Group. 

A chairperson shall be elected by consensus of the Scientific Committee from among 
its members. 

The Scientific Committee shall have the following tasks: 

(a) 

advise on the continued relevance of the Research Agenda and recommend any 
amendments; 

(b) 

advise on the scientific priorities for the annual implementation plan proposal; 

(c) 

advise  the  Board  and  the  Executive  Office  on  the  scientific  achievements 
described in the annual activity report; 

EN 

28 

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7. 

8. 

1. 

2. 

3. 

4. 

(d) 

advise on the composition of the peer review committees. 

The Scientific Committee shall meet at least once a year.  

The  Scientific  Committee  may,  with  the  agreement  of  the  chairperson,  invite  non-
member persons to participate in its meetings for advice. 

Article 8 
Sources of financing 

All resources of the IMI Joint Undertaking and its activities shall be devoted to the 
objectives provided for in Article 2. 

The resources of the IMI Joint Undertaking entered to its budget shall be composed 
of: 

(a)  Members’ financial contributions, 

(b) 

any revenue generated by the IMI Joint Undertaking; 

(c) 

any other contributions, resources and revenues. 

Any interest yielded by the contributions paid by its Members shall be considered to 
be revenue of the IMI Joint Undertaking. 

The  total  contribution  from  the  Community  to  the  IMI  Joint  Undertaking  covering 
running  costs  and  Research  Activities  shall  not  exceed  EUR  1  billion  from  the 
Seventh Framework Programme. 

The  running  costs  shall  not  exceed  4  %  of  the  total  budget  of  the  IMI  Joint 
Undertaking for the initial period ending on 31 December 2017. The running costs of 
the  IMI  Joint  Undertaking  shall  be  financed  by  its  Members  and  shall  be 
proportionate to the total contribution towards the Research Activities: 

(a) 

The Founding Members shall contribute in equal parts; 

(b) 

Any  other  Member  shall  contribute  in  proportion  to  its  total  contribution 
towards the Research Activities. 

5. 

The Research Activities shall be jointly funded by its Members through: 

(a) 

voluntary  contributions  by  the  research  based  pharmaceutical  companies  that 
are  full  members  of  EFPIA,  with  resources  (such  as  personnel,  equipment, 
consumables,  etc.)  at  least  equal  to  the  financial  contribution  of  the 
Community; 

(b) 

a  matching  financial  contribution  of  the  Community  from  the  Seventh 
Framework Programme entered to the budget of the IMI Joint Undertaking; 

(c) 

contributions from Members referred to in Art 3(2). 

EN 

29 

   EN 

 
6. 

7. 

8. 

Contributions in kind shall be subject to an evaluation of their value and utility for 
carrying out the tasks of the IMI Joint Undertaking, and to acceptance by the Board. 

The participating research based pharmaceutical companies that are full members of 
EFPIA  shall  not  be  eligible  to  receive  any  financial  support  from  the  IMI  Joint 
Undertaking for any activity. 

Should  any  Member  of  the  IMI  Joint  Undertaking,  or  any  participating  research 
based  pharmaceutical  company  that  is  a  full  member  of  EFPIA,  fail  to  meet  its 
commitments  concerning  its  agreed  contributions,  the  Executive  Director  shall 
convene a meeting of the Board to decide: 

(a) 

(b) 

in  the  case  of  a  defaulting  Member,  whether  its  membership  should  be 
terminated, or if any other measures should be taken until it has been met its 
obligations; or  

in the case of a defaulting participating research based pharmaceutical company that 
is a full member of EFPIA, which appropriate measures should be taken. 

9. 

The IMI Joint Undertaking shall own all assets generated by it or transferred to it for 
the fulfilment of its objectives provided for in Article 2. 

Article 9 
Financial commitments 

1. 

2. 

Financial commitments of the IMI Joint Undertaking shall not exceed the amount of 
resources at its disposal. 

Except in the case of winding up of the IMI Joint Undertaking, subject to Article 19, 
the excess revenue over expenditure shall not give rise to payments to the Members 
of the IMI Joint Undertaking. 

Article 10 
Financial year 

The financial year shall correspond to the calendar year. 

Article 11 
Financial Regulation  

1. 

2. 

The IMI Joint Undertaking’s financial regulation shall be agreed and adopted by the 
Board. 

The purpose of the financial regulation is to ensure the sound financial management 
of the IMI Joint Undertaking. 

EN 

30 

   EN 

 
3. 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

The IMI Joint Undertaking's Financial Regulation shall be based on the principles of 
the Framework Financial Regulation23. It may depart from the Framework Financial 
Regulation  where  the  specific  operating  needs  of  the  IMI  Joint  Undertaking  so 
require and subject to prior consultation with the Commission. 

Article 12 
Financial reporting 

Every  year,  the  Executive  Director  shall  present  to  the  Board  a  preliminary  draft 
budget  which  shall  include  a  forecast  of  annual  expenditure  for  the  following  two 
years. Within this forecast, the estimates of revenue and expenditure for the first of 
those  two  financial  years  shall  be  drawn  up  in  such  detail  as  is  necessary  for  the 
internal budgetary procedure of each Member regarding its financial contributions to 
the  IMI  Joint  Undertaking.  The  Executive  Director  shall  supply  the  Board  with  all 
supplementary information needed for this purpose. 

The  Board  shall  forthwith  communicate  to  the  Executive  Director  its  comments  on 
the  preliminary  draft  budget  and  in  particular  on  the  estimates  of  resources  and 
expenditure for the following year. 

Taking into account the comments received from the Board, the Executive Director 
shall  prepare  the  draft  budget  for  the  following  year.  Before  September  1  of  each 
year,  the  Executive  Director  shall  submit  the  annual  budget  to  the  Board  for 
approval. 

Within two months after the closure of each financial year, the annual accounts and 
balance sheets for the preceding year shall be submitted by the Executive Director to 
the Board for approval. 

The annual accounts and balance sheets for the preceding year shall be submitted to 
the Court of Auditors of the European Communities. An audit may be executed by 
the Court of Auditors in accordance with its standard procedures. 

Article 13 
Annual planning and reporting 

The  annual  implementation  plan  shall  describe  the  activities  of  IMI  Joint 
Undertaking  planned  for  the  coming  year  and  the  corresponding  expenditure 
estimates. 

An annual activity report shall describe the performed Research Activities and other 
activities during the previous year and the corresponding expenditure. 

23 

OJ L 357, 31.12.2002 p. 72; corrigendum in OJ L 2, 7.12003, p. 39 

EN 

31 

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3. 

1. 

2. 

The  expenditure  shall  be  based  on  Members’  financial  contributions  as  well  as 
contributions  from  participating  research  based  pharmaceutical  companies  that  are 
full members of EFPIA. 

Article 14 
Staff 

The staff resources shall be determined in the establishment plan to be set out in the 
annual budget. 

The members of the staff of the IMI Joint Undertaking shall be temporary agents and 
contract agents and shall have fixed term contracts extendable once up to a maximum 
total period of seven years. 

3. 

The staff expenditure shall be borne by the IMI Joint Undertaking. 

Article 15 
Liability and Insurance 

1. 

2. 

The IMI Joint Undertaking shall be solely responsible for meeting its obligations. 

The financial liability of the Members for the debts of the IMI Joint Undertaking is 
limited  to  their  contribution  already  made  for  the  running  expenditure  as  set  out  in 
Article 8. 

3. 

The IMI Joint Undertaking shall take out and maintain appropriate insurance. 

Article 16 
Conflict of Interests 

The  IMI  Joint  Undertaking  shall  avoid  any  conflict  of  interest  in  the  implementation  of  its 
activities. 

Article 17 
Research activities, Grant Agreements and Project Agreements 

The  IMI  Joint  Undertaking  shall  support  research  activities  following  competitive 
calls for proposals, independent evaluation, and the conclusion of Grant Agreements 
and Project Agreements. 

The  IMI  Joint  Undertaking  shall  set  up  the  procedures  and  mechanisms  for  the 
implementation, supervision and control of concluded Grant Agreements. 

The Grant Agreement shall: 

1. 

2. 

3. 

(a) 

set  up  the  appropriate  arrangements  for  the  implementation  of  the  research 
activities; 

EN 

32 

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(b) 

(c) 

set  up  the  appropriate  financial  arrangements  and  the  rules  relating  to 
intellectual property rights on the basis of the principles as set out in Article 22; 

govern  the  relationship  between  the  selected  consortium  and  the  IMI  Joint 
Undertaking. 

4. 

The Project Agreement, hereinafter referred to as Project Agreement, shall: 

(a) 

set  up  the  appropriate  arrangements  for  the  implementation  of  the  Grant 
Agreement; 

(b) 

govern the relationship between the participants in a project. 

5. 

The  Community  contribution  to  the  IMI  Joint  Undertaking  shall  be  used  for  the 
implementation  of  the  Research  Activities.  The  following  legal  entities  are  eligible 
for such funding: 

(a) 

micro, small and medium-sized enterprises within the meaning of Commission 
Recommendation 2003/361/EC24; 

(b) 

legal entities established as non-profit public bodies under national law;  

(c) 

intergovernmental  organisations,  which  have 
legal  personality  under 
international  public  law,  as  well  as  any  specialised  agencies  set  up  by  such 
intergovernmental organisations;  

(d) 

legal entities established under Community law;  

(e) 

legal  entities  established  as  non-profit  organisations  which  carry  out  research 
or technological development as one of their main objectives;  

(f) 

secondary and higher education establishments; 

(g) 

non-profit qualified patients organisations. 

Article 18  
Service and supply contracts 

The  IMI  Joint  Undertaking  shall  set  up  all  the  procedures  and  mechanisms  for  the 
implementation, supervision and control of concluded service and supply contracts necessary 
for  the  operations  of  the  IMI  Joint  Undertaking,  according  to  the  provisions  of  its  financial 
regulation. 

24 

O J L 124, 20.2003, p.36 

EN 

33 

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Article 19  
Winding up 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

At the end of the period provided for in Article 1(3), or following a decision by the 
Council, the IMI Joint Undertaking shall be wound up.  

The  winding  up  procedure  shall  be  automatically  triggered  if  one  of  the  Founding 
Members terminates its membership of the IMI Joint Undertaking. 

For  the  purpose  of  conducting  the  proceedings  in  winding  up  of  the  IMI  Joint 
Undertaking, the Board shall appoint one or more liquidators, who shall comply with 
the decisions of the Board. 

When the IMI Joint Undertaking is being wound up, it shall return to the host state 
any  physical  support  item  made  available  by  the  host  state  in  accordance  with  the 
host agreement.  

When any physical support item has been dealt with as provided in paragraph 4, any 
further assets shall be used to cover the liabilities of the IMI Joint Undertaking and 
the expenditures relating to its winding up. Any surplus or deficit shall be distributed 
among or met by the Members existing at the time of the winding up in proportion of 
their actual contribution to the IMI Joint Undertaking.  

Remaining assets, debts or liabilities shall be distributed to the Members existing at 
the time of the winding up in proportion to their actual contribution to the IMI Joint 
Undertaking. 

An  ad  hoc  procedure  shall  be  set  up  to  ensure  the  appropriate  management  of  any 
Grant Agreement referred to in Article 17 and service and supply contract referred to 
in Article 18, with duration longer than the duration of the IMI Joint Undertaking.  

Article 20 
Preparatory actions 

The  Founding  Members  shall  be  responsible  for  carrying  out  all  activities  relating  to  the 
establishment of the IMI Joint Undertaking until the bodies responsible for its operation have 
been set up. 

Article 21  
Amending the Statutes 

1. 

2. 

Any Member of the IMI Joint Undertaking may make a proposal to the Board for the 
amendment of these Statutes. 

Amendment  to  these  Statutes  shall  be  approved  by  the  Board.  If  such  amendment 
affects  the  overall  principals  and  objectives  of  these  Statutes,  in  particular  any 
amendment  to  Article  1,  first  indent  of  Article  5(2)(c),  Article  8(3)  and  Article  21 
shall be subject to approval by the Council based on a proposal by the Commission. 

EN 

34 

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Article 22 
Intellectual property policy 

1. 

2. 

The  IMI  Joint  Undertaking  shall  adopt  its  general  rules  governing  the  intellectual 
property policy of the IMI Joint Undertaking that will be incorporated in the Grant 
Agreements and Project Agreements. 

The  objective  of  the  intellectual  property  policy  of  the  IMI  Joint  Undertaking  is  to 
promote knowledge creation, together with its disclosure and exploitation, to achieve 
fair allocation of rights, to reward innovation, and to achieve a broad participation of 
private and public entities (including, but not limited to, participating research based 
pharmaceutical  companies  that  are  full  members  of  EFPIA,  academic  groups  and 
small and medium-sized enterprises) in projects. 

3. 

The Intellectual Property policy shall reflect the following principles: 

(a) 

(b) 

Each participant in a project shall remain the owner of the intellectual property 
that it introduces into a project, and shall remain the owner of the intellectual 
property that it generates in a project unless otherwise mutually agreed by the 
participants in a project. The terms and conditions of access rights and licenses 
with  regard  to  the  intellectual  property  introduced  into  or  generated  by 
participants  in  a  project,  shall  be  defined  in  the  Grant  Agreement  and  the 
Project Agreement of the project concerned. 

Participants in a project shall undertake to disseminate and allow the use of the 
results and the  intellectual property generated by the project concerned under 
terms  and  conditions  defined  in  the  Grant  Agreement  and  the  Project 
Agreement  taking  into  account  the  protection  of  intellectual  property  rights, 
confidentiality obligations and legitimate interests of the owners. 

Article 23 
Applicable Law 

In any matter not covered by these Statutes or by acts of Community law, the law of the state 
where the seat of the IMI Joint Undertaking is located shall apply. 

EN 

35 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

Proposal for Council Regulation setting up the Innovative Medicines Initiative Joint 
Undertaking 

2. 

ABM / ABB FRAMEWORK 

Policy Area(s) concerned and associated Activity/Activities: 

Research  and  Technological  Development:  7th  Framework  Programme,  Specific 
Programme "Cooperation", Theme "Health" 

3. 

BUDGET LINES 

3.1. 

Budget  lines  (operational  lines  and  related  technical  and  administrative 
assistance lines (ex- B..A lines)) including headings: 

08.02  01  10  "Operational  expenditures  for  research  activities  of  the  IMI  Joint 
Undertaking" 

08.02 01 20 "Support expenditures for running costs of the IMI Joint Undertaking" 

3.2. 

Duration of the action and of the financial impact: 

The IMI Joint Undertaking is expected to be established by Council Decision before 
the end of 2007 for a period of up to 31 December 2017. Its financial impact on the 
EU budget will cease after 2013. 

3.3. 

Budgetary characteristics : 

Budget line 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

08.02.01 10 

Non-
comp 

Diff 

YES 

YES 

YES 

No 1 A 

08.02 01 20 

Non-comp 

Non-
diff 

YES 

YES 

YES 

No 1 A 

EN 

36 

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4. 

SUMMARY OF RESOURCES 

4.1. 

Financial Resources 

All  figures  presented  in  this  statement  are  indicative  and  presented  in  constant 
values.  

4.1.1. 

Summary of commitment appropriations (CA) and payment appropriations (PA) 

EUR million (to 3 decimal places) 

Expenditure type 

Section 
no. 

Year 
2008 

2009 

2010 

2011 

2012 

2013 
and later 

Total 

Operational expenditure25 

Commitment Appropriations 
(CA) 

8.1. 

Payment 
(PA) 

Appropriations 

a 

b 

122.700 

76.800 

95.800 

155.400 

294.300 

215.000 

960.000 

122.700 

76.800 

95.800 

155.400 

294.300 

215.000 

960.000 

Administrative expenditure within reference amount26 

Technical  &  administrative 
assistance (NDA) 

8.2.4. 

c 

TOTAL REFERENCE AMOUNT 

2.300 

3.200 

4.200 

4.600 

5.700 

20.000 

40.000 

Commitment 
Appropriations 

a+c  125.000 

80.000 

100.000 

160.000 

300.000 

235.000 

1000.000 

Payment Appropriations 

b+c  125.000 

80.000 

100.000 

160.000 

300.000 

235.000 

1000.000 

Administrative expenditure not included in reference amount27 

Human 
associated 
(NDA) 

resources 

and 
expenditure 

Administrative  costs,  other 
than  human  resources  and 
not 
associated 
reference 
in 
included 
amount (NDA) 

costs, 

8.2.5. 

d 

0.702 

0.351 

0.000 

0.000 

0.000 

0.000 

1.053 

8.2.6. 

e 

0.335 

0.109 

0.166 

0.166 

0.000 

0.166 

0.942 

25 
26 
27 

Expenditure 08.02 01 10 "Operational expenditures for research activities of the IMI Joint Undertaking" 
Expenditure 08.02 01 20 "Support expenditures for running costs of the IMI Joint Undertaking" 
The reference amount does not include the administrative expenditure from the Research budget that is 
not transferred to the IMI Joint Undertaking.  

EN 

37 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Total indicative financial cost of intervention 

TOTAL CA including cost 
of Human Resources 

TOTAL  PA  including  cost 
of Human Resources 

a+c
+d
+e 

b+c
+d
+e 

126.037 

80.460 

100.166 

160.166 

300.000 

235.166 

1001.995 

126.037 

80.460 

100.166 

160.166 

300.000 

235.166 

1001.995 

Co-financing details 

The founding members of the IMI Joint Undertaking shall be: 

- The European Community, represented by the Commission; 

-  The  European  Federation  of  Pharmaceutical  Industries  and  Associations 
(hereinafter referred to as “EFPIA”), a non-profit association registered under Swiss 
law  with  its  permanent  office  in  Brussels,  Belgium.  EFPIA  operates  as  a 
representative organisation of the Pharmaceutical Industry in Europe.  

The  running  costs  of  the  IMI  Joint  Undertaking  shall  be  covered  by  its  members 
(European  Community  and  EFPIA).  The  European  Community  and  EFPIA  shall 
contribute  on  an  equal  level.  The  research  activities  of  the  IMI  Joint  Undertaking 
(operational costs) shall be covered by funding from the European Community and at 
least on an equal level by resources (in kind) from the research based pharmaceutical 
companies that are full members of EFPIA. 

EUR million (to 3 decimal places) 

Co-financing body 

EFPIA  and  the  research 
pharmaceutical 
based 
companies  that  are  full 
members of EFPIA 

2009 

2010 

2011 

2012 

2013  and 
later 

Total 

Year 
2008 

f 

125.000 

80.000 

100.000 

160.000 

300.000 

235.000 

1000.000 

TOTAL  CA  including 
co-financing 

a+c+d
+e+f 

251.037 

160.460 

200.166 

320.166 

600.000 

470.166 

2001.995 

4.1.2.  Compatibility with Financial Programming 

X 

Proposal is compatible with existing financial programming. 

(cid:133) 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the  financial 
perspective. 

EN 

38 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:133) 

Proposal  may  require  application  of  the  provisions  of  the  Interinstitutional 
Agreement28 (i.e. flexibility instrument or revision of the financial perspective). 

4.1.3.  Financial impact on Revenue 

X 

Proposal has no financial implications on revenue 

(cid:133) 

Proposal has financial impact – the effect on revenue is as follows: 

Budget line 

Revenue 

EUR million (to one decimal place) 

Situation following action 

[Yea
r n] 

[n+1] [n+2]  [n+3

] 

[n+4] [n+5]

29

Prior to
action 
[Year 
n-1] 

a) Revenue in absolute terms 

b) Change in revenue 

 Δ 

4.2. 

Human Resources FTE (including officials, temporary and external staff) – see 
detail under point 8.2.1. 

Annual requirements 

2008 

2009 

2010 

2011 

2012 

2013 
and 
later 

Total  number  of  human 
resources 

17 

28 

34 

34 

36 

174 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1. 

Need to be met in the short or long term 

The needs are:  

(a) 

(b) 

To set up the IMI Joint Undertaking, as a new scheme of partnership between 
the Commission and industry for research funding;  

To  organise  the  competitive  calls  for  proposals,  evaluation  and  selection  of 
projects  where  industry  will  co-fund  the  selected  collaborative  research 
projects performed in A Member State or a country associated to the Seventh 
Framework  Programme, 
together  with  academic,  SMEs,  and  patients 
associations supported by the funds coming from the IMI Joint Undertaking;  

28 
29 

See points 19 and 24 of the Interinstitutional agreement. 
Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years 

EN 

39 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(c) 

(d) 

(e) 

To  monitor  and  follow-up  financial  and  scientific  aspects  (including  the 
knowledge management) of projects having concluded a grant agreement with 
the IMI Joint Undertaking; 

To  organise  the  calls  for  tender  necessary  to  the  operations  of  IMI  Joint 
Undertaking, 

To  set  up  and  implement  all  procedures  linked  to  the  IMI  Joint  Undertaking, 
including financial auditing; 

(f) 

To organise dissemination activities of the IMI Joint Undertaking;  

(g) 

To organise the communication activities of the IMI Joint Undertaking; 

(h) 

To organise any other activity linked to the IMI Joint Undertaking 

5.2. 

Value-added  of  Community  involvement  and  coherence  of  the  proposal  with 
other financial instruments and possible synergy 

These  issues  are  addressed  in  the  impact  assessment  document  attached  to  this 
proposal that is based on a socio-economic impact assessment performed by a panel 
of  independent  external  experts,  as  well  as  on  a  "Keys  to  success"  document 
provided by the industry. 

5.3. 

Objectives, expected results and related indicators of the proposal in the context 
of the ABM framework 

1) Objectives and expected results. 

The  Innovative  Medicines  Joint  Technology  Initiative  (IMI  JTI)  aims  to  strengthen 
Europe’s position in biopharmaceutical research. It will re-invigorate the European -
pharmaceutical sector, make Europe more attractive to private R&D investment and, 
in  the  long  term,  provide  European  citizens  with  faster  access  to  better  medicines, 
improvement  of  their  health,  quality  of  life  and  well-being.  IMI  is  expected  to 
introduce a new dimension of research collaboration to the biopharmaceutical sector; 
between  pharmaceutical  companies,  which  normally  compete,  and  with  other  key 
stakeholders, such as, small companies, academic scientists, clinicians, patients and 
regulators.  IMI  therefore  responds  to  the  major  European  policies,  in  particular  the 
Lisbon  and  3  %  objectives.  It  will  contribute  towards  establishing  the  European 
Research Area and it will also respond to calls for action recommended in report of 
the  High  Level  Group  on  innovation  and  provision  of  medicines  (G10  Medicines, 
2002) and in report for "Creating an Innovative Europe" ("Aho report", 2006). 

The  IMI  Joint  Undertaking  shall  contribute  to  the  implementation  of  the  Seventh 
Framework  Programme  of  the  European  Community  for  research,  technology 
development and demonstration activities (2007-2013) and the Theme 'Health' of the 
the  Seventh  Framework 
Specific  Programme 
Programme  (2007-2013)  of  the  European  Community  for  research,  technology 
development and demonstration activities, and, in particular to: 

implementing 

'Cooperation' 

EN 

40 

   EN 

 
•  support 'pre-competitive pharmaceutical research and development' in Europe via 
a coordinated approach to overcome the identified research bottlenecks in the drug 
development process; 

•  support  the  implementation  of  the  research  priorities  as  set  out  by  the  Research 
Agenda  of  the  IMI  Joint  Undertaking,  notably  by  awarding  grants  following 
competitive calls for proposals; 

•  promote a public-private partnership aiming at increasing the research investment 
in the biopharmaceutical sector in the Members States and countries associated to 
the  Seventh  Framework  Programme  by  pooling  resources  and  fostering 
collaboration between the public and private sectors; 

•  conclude  service  and  supply  contracts  necessary  for  the  operations  of  the  IMI 

Joint Undertaking; 

•  ensure  the  efficiency  and  durability  of  the  Joint  Technology  Initiative  on 

"Innovative Medicines". 

2)  Indicators  are  proposed  in  the  impact  assessment  document  attached  to  this 
proposal (see Audit). 

Performance  indicators  shall  be  established  in  consultation  with  the  relevant 
Commission  services  and  in  agreement  with  EFPIA  (based  on  their  position  paper 
"Keys  for  Success")  and  shall  take  into  account  also  advice  from  the  independent 
expert group analysing the economy and societal effects of IMI JTI. 

The performance indicators are distinguished into: 

a) Indicators measuring the impact of IMI JU on EU competitiveness (e.g., amount 
of private investment R&D in the EU compared to the rest of the world). 

b) Indicators measuring the impact of IMI on the Scientific Environment (number of 
validated biomarkers, new and amended regulatory guidelines, change in mean time 
to approval by therapeutic area). 

These  indicators  will  be  measured  and  reported  in  every  IMI  JU  annual  activity 
report  and  the  evolution  and  progress  annually  reported  to  the  Council  and 
Parliament  by  the  Commission.  In  addition,  they  represent  key  points  in  assessing 
IMI JU performance in an interim evaluation in 2010 and final evaluation in 2017 by 
independent experts. In order to help assess IMI JU's additionality effects during its 
lifetime,  it  is  foreseen  that  a  series  of  "baseline  studies"  focusing  on  using  this 
performance indicators in the pre-IMI-area (2005, 2006, 2007) will be performed.  

EN 

41 

   EN 

 
5.4.  Method of Implementation (indicative) 

Show below the method(s)30 chosen for the implementation of the action. 

(cid:133)  Centralised Management 

(cid:133) 

directly by the Commission 

X 

indirectly by delegation to: 

(cid:133) 

executive Agencies 

X 

bodies set up by the Communities as referred to in art. 185 of the 
Financial Regulation 

(cid:133) 

national public-sector bodies/bodies with public-service mission 

(cid:133) 

Shared or decentralised management 

(cid:133)  with Member states 

(cid:133)  with Third countries 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: Further details annexed. 

6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

The Joint Undertaking will be monitored as provided in its Statutes. 

6.2. 

Evaluation 

6.2.1.  Ex-ante evaluation 

These  issues  are  addressed  in  the  impact  assessment  document  attached  to  this 
proposal that is based on a socio-economic impact assessment performed by a panel 
of  independent  external  experts,  as  well  as  on  a  "Keys  to  success"  document 
provided by the industry. It provides most of the information required by an ex-ante 
evaluation on the establishment of the IMI Joint Undertaking. 

6.2.2.  Measures taken following an intermediate/ex-post evaluation (lessons  learned from 

similar experiences in the past) 

Not applicable. 

30 

If  more  than  one  method  is  indicated  please  provide  additional  details  in  the  "Relevant  comments" 
section of this point. 

EN 

42 

   EN 

 
                                                 
6.2.3.  Terms and frequency of future evaluation 

Described under Article 13 of the proposed Regulation. 

7. 

ANTI-FRAUD MEASURES  

Described under Article 14 of the proposed Regulation. 

EN 

43 

   EN 

 
8. 

DETAILS OF RESOURCES 

8.1. 

Objectives of the proposal in terms of their financial cost 

Type of output 

Av. 
cost 

Year 2008 

Year 2009 

Year 2010 

Year 2011 

Year 2012 

Year 2013 and later 

TOTAL 

No. 
outputs 

Total cost 

No. 
outputs 

Total cost  No. 

outputs 

Total cost  No. 
outp
uts 

Total cost 

No. 
outputs 

Total cost 

No. 
outputs 

Total cost 

No. 
outputs 

Total cost 

Commitment appropriations in EUR million (to 3 decimal places) 

of 

(Headings 
Objectives, 
and 
actions 
outputs should be 
provided) 

OPERATIONAL 
OBJECTIVE  No.1 
31Implementing 
the 
Research 
Agenda of the IMI 
Joint Undertaking 

Action  1  Support 
for 
research 
projects 

- Output 1 (*)  Research 

Projects funded 

10 

13 

122.700 

7 

76.800 

10 

95.800 

16 

155.400 

29 

294.300 

21 

215.000 

96 

960.000 

TOTAL COST 

122.700 

76.800 

95.800 

155.400 

294.300 

215.000 

960.000 

(*) Compared to other Seventh Framework programme activities, projects to be supported under the IMI Joint Undertaking are expected to have a large 
scale, with an average total cost per project of € 20 million, out of which 50% (€ 10 million) is supported by the IMI JU (i.e. from EU contribution) and 
the other 50% (€ 10 million) by in kind contributions from research based pharmaceutical companies that are full members of EFPIA. 

31 

As described under Section 5.3. 

EN 

44 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2. 

Administrative Expenditure 

8.2.1.  Number and type of human resources (indicative) 

Types of post 

Staff to be assigned to management of the action using existing and/or 
additional resources (number of posts/FTEs) 

Year 
2008 

Year 
2009 

Year 
2010 

Year 
2011 

Year 
2012 

Year 
2013 
and later 

Officials or 
temporary 
staff32 

A*/AD 

B*, 
C*/AST 

Staff  financed33  by  art. 
XX 01 02 

Other staff34  

AD 

AST 

external 

TOTAL 

5 

1 

0 

6 

3 

2 

17 

2 

1 

0 

14,5 

5,5 

5 

28 

0 

0 

0 

22 

7 

5 

34 

0 

0 

0 

22 

7 

5 

34 

0 

0 

0 

23 

8 

5 

36 

0 

0 

0 

110 

36 

28 

174 

8.2.2.  Description of tasks deriving from the action 

The tasks of the IMI Joint Undertaking are described under Article 2 of the Statutes. 
The specific tasks of the Executive Director and the Executive office are described 
under Article 6 of the Statutes. In addition the preparatory actions for setting up the 
IMI Joint Undertaking are referred to in Article 17 of the Regulation 

8.2.3. 

Sources of human resources (statutory) 

(cid:133) 

(cid:133) 

(cid:133) 

X 

X 

Posts currently allocated to the management of the programme to be replaced 
or extended 

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

Posts  to  be  redeployed  using  existing  resources  within  the  managing  service 
(internal redeployment) 

Posts required for year n although not foreseen in the APS/PDB exercise of the 
year in question 

32 
33 
34 

Cost of which is NOT covered by the reference amount  
Cost of which is NOT covered by the reference amount  
Cost  of  which  is  included  within  the  reference  amount  under  08.02  01  20  and  the  contribution  from 
EFPIA 

EN 

45 

   EN 

 
 
 
 
                                                 
8.2.4.  Other  Administrative  expenditure  included  in  reference  amount  (08.02  01  20  "Support 

expenditures for running costs of the IMI Joint Undertaking") 

EUR million (to 3 decimal places) 

Budget line 

(number and heading) 

Year 
2008 

Year 
2009 

Year 
2010 

Year 
2011 

Year 
2012 

Year 
2013 and 
later 

TOTAL 

Technical 

and 
1 
assistance (including related staff costs) 

administrative 

Executive agencies35 

Other 

technical 

and 

administrative 

assistance 

- intra muros  

- extra muros 

IMI Joint Undertaking (**) 

2.300 

3.200 

4.200 

4.600 

5.700 

20.000 

40.000 

Total  Technical  and  administrative 
assistance 

2.300 

3.200 

4.200 

4.600 

5.700 

20.000 

40.000 

(**) The IMI Joint Undertaking will be established under Art. 171 

Calculation– (for the duration of the IMI Joint Undertaking) 

The indicative costs referred to in the table above only concerns the Community contribution 
to  the  running  costs  of  the  IMI Joint  Undertaking. This contribution represents 50 % of the 
total running costs of the IMI Joint Undertaking.. 

Staff:  average  cost  of  €  117,000  per  FTE  per  year  for  AD/AST,  and  €  51,000  per  FTE  per 
year for external. Community contribution amounts to € 16,7 million 

Other  running  expenditure:  Estimated  Community  contribution  amounts  to  €  23.3  million, 
including:  evaluation,  monitoring  of  projects,  communication  activities,  organisation  of 
meetings, travel and subsistence, office running costs, IT, auditing, etc.  

35 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

EN 

46 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.5.  Financial cost of human resources and associated costs not included in the reference 

amount 

EUR million (to 3 decimal places) 

Type of human resources 

Year 
2008 

Year 
2009 

Year 
2010 

Year 
2011 

Year 
2012 

Year 
2013 
and later 

Officials and temporary staff 

0.702 

0.351 

0 

0 

0 

0 

Staff  financed  by  Art  XX  01 
02  (auxiliary,  END,  contract 
staff, etc.) 

(specify budget line) 

cost 

Total 
of  Human 
Resources  and  associated 
costs 
in  reference 
amount) 

(NOT 

0.702 

0.351 

0 

0 

0 

0 

Calculation– Officials and Temporary agents 

The  human  resources  referred  to  in  table  8.2.5  are  calculated  with  an  average  cost  of  € 
117,000 per FTE per year. 

EN 

47 

   EN 

 
 
 
 
 
 
 
 
 
 
8.2.6. Other administrative expenditure not included in reference amount 

EUR million (to 3 decimal places)

Year 
2008 

Year 
2009 

Year 
2010 

Year 
2011 

Year 
2012 

Missions 

0.019 

0.009 

Meetings & Conferences 

0.050 

Year 
2013
and 
later 

TOTAL 

0.028 

0.050 

Committees36 

Studies & consultations 

0.166 

0.166 

0.166 

0.166 

0.664 

Information systems 

0.100 

0.100 

0.200 

2 

Total 

Other  Management 

0.335 

0.109 

0.166 

0.166 

0.166 

0.942 

Expenditure  

3  Other 

expenditure 

administrative 
including reference to budget line) 

nature 

of 

an 
(specify 

expenditure, 
than  human  resources  and 
in 

Total  Administrative 
other 
associated  costs  (NOT 
reference amount) 

included 

0.109 

0.166 

0.166 

0.166 

0.335 

0.942 

36 

See details of calculation in the annex  

EN 

48 

   EN