1. IMI Member States Contact Group
Questions & Answers
European Commission
Brussels
23 November 2006

2. Questions received from
Member States
Concerns:
IMI legal status
IMI governance, structure and management
Strategic Research Agenda (SRA)

3. The way to IMI
Joint Undertaking

4. « Innovative Medicines » European Technology Platform (ETP)
Stakeholders
driven
« Innovative Medicines »
European Technology Platform (ETP)
Consultation step
« Innovative Medicines Initiative »
Joint Technology Initiative (IMI JTI)
Conceptualisation step
EC, EFPIA &
Stakeholders
driven
Council driven
« Innovative Medicines Initiative »
Joint Undertaking (IMI JU)
Legalisation step

5. Definitions The Innovative Medicines Initiative
Joint Technology Initiative (IMI JTI)
is a new research funding instrument characterized by a private/public
partnership
The IMI Joint Undertaking (IMI JU)
is the legal entity whose responsability
is to implement IMI JTI

6. Innovative Medicines Initiative Joint Technology Initiative (IMI JTI)
Joint Undertaking (IMI JU)
Board
Executive
Office
Scientific
Committee
Stakeholder’s
Forum
Member
States Group

7. IMI legal status

8. What form of legal entity for IMI:
Question 1:
What form of legal entity for IMI:
European Economic Interest Group (EEIG)?
Foundation? Executive Agency?
« A Joint Undertaking on the basis of
Article 171 of the Treaty»
Article 171: « The Community may set up joint
undertakings or any other structure necessary for the
efficient execution of Community research,
technological developments and demonstration
Programmes »

9. A Joint Undertaking is neither a public or private entity
It is a non-governmental, non-profit organisation,
sui generis structure, under the authority of the
national applicable law

10. How and by who will this Joint Undertaking be adopted?
Question 2:
How and by who will this Joint Undertaking be adopted?
Article 172: « The Council, acting by qualified majority
on a proposal from the Commission and after consulting
the European Parliament and the
Economic and Social Committee,
shall adopt the provisions referred to in Article 171 »
IMI shall be based on a Council decision
IMI Statutes shall be part of the Council decision
For any matter not covered by the Statutes,
the law of the State where the Head Office
of the Joint Undertaking shall be located shall apply

11. Will the establishment of IMI as a legal entity be
Question 3:
Will the establishment of IMI as a legal entity be
dependent upon the granting of funds from the FP7?
(i.e. IMI established only after award of FP7 funding)
Yes: Funds from EU to the IMI Joint Undertaking for
research projects as well as for part of the running
costs of the « Executive Office » will be provided
through FP7
Therefore:
FP7 adoption is crucial for IMI
IMI EU funding is planned for the duration
of FP7 (till 2013)

12. Question 4: What is IMI share of FP7 ?
The EC contribution to IMI is proposed to be
€ 1 billion total for the period (FP7)
The annual contribution will start in the range
of € 100 mil and gradually increase to reach
€ 300 mil at the end of the period
EC contribution should be matched by industry
contribution

13. Where will the budget come from in FP7 ?
Question 5:
Where will the budget come from in FP7 ?
EU FP7
“Health” Theme
“Cooperation” Pillar
€ 50.5 bil
€ 32.3 bil
€ 6 bil
IMI
€ 1 bil

14. What will be the additional share of the Member States to IMI ?
Question 6:
What will be the additional share
of the Member States to IMI ?
Member States will not be asked to directly
contribute financially to IMI JU
However, contributions at national level are
essential for « mirror activities » at Member
States level, as well as for the implementation
of the « Education & Training » pillar of the SRA

15. IMI governance, structure
& management

16. Governance principles
Basic principles have been described on the slides provided at the IMI Member States Group meeting of 20 March 2006

17. Your questions related to the Board
Q1: Composition of the Board & Chair ?
Q2: Membership of new funding members ?
Q3: How do they make decisions ?

18. Board Alternate yearly Chair Meets twice a year EC EFPIA
What is its role ?
Decision making
Responsible for overall operations of IMI
What is the principle for decision making ?
By Consensus
What about accession of new members ?
Open to any organisation, assessment case by case

19. Executive Office Recruited by IMI JU Work full time for IMI JU……
What is its role ?
Implementing decisions of the Board
Managing day to day operations of IMI and implementing all operational aspects
How does it operate and to who does it report ?
An Executive Director will be the chief executive responsible and will report to the Board

20. Who will support IMI running costs?
Executive Office ……
Additional Question
Who will support IMI running costs?
The costs for running the “Executive Office”
shall be covered in cash by EFPIA and EU
on an equal basis

21. Your questions related to the
Scientific Committee
Q1: Composition & procedure for nomination
Q2: Clarification on the role
Q3: How is it done elsewhere?

22. Scientific Committee Chair elected for 2 years Meets four times a year
15 members
What is its role ?
Scientific advisory body to the Board and Executive Office
Composition and expertise ?
Composition of the Scientific Committee shall reflect a balanced/translational representation of academic, patient, industry and regulatory expertise
How are the members selected ?
Board nominates 30 candidates to the Member States Group who selects 15 for forming the SC

23. Your questions related to the
Member States Group
Q1: Composition & procedure for nomination
Q2: Clarification on the role
Q3: How is it done elsewhere?

24. Member States Group MS, CC, AC ……............ What is its role ?
To facilitate communication between IMI and the EU Member States, the Candidate Countries and Associated countries
Responsible for the final selection of Members of the Scientific Committee
Responsible for the implementation of some specific areas and/or topics of the Strategic Research Agenda, in particular concerning “Education & Training”
Composition and expertise ?
One nominee per country

25. Member States Group MS, CC, AC Additional Question 1……
MS, CC, AC
Additional Question 1
Will IMI provide funds to Member States to undertake
activities such as organising national
information meetings
Pure national activities and the related costs should
be assumed by the Member States

26. Member States Group MS, CC, AC Additional Question 2……
MS, CC, AC
Additional Question 2
Clarification of the involvement of the Member States
in "Education and Training Activities“
and of the related financial consequences for them
How do you perceive your role and financial
involvement ?

27. Your questions related to the
Stakeholders’ Forum
Q1: Selection criteria ?
Q2: How many people ?
Q3: Nature of the fields/area to be covered ?

28. Stakeholder’s Forum Open Forum Convenes once a year undefined number……
undefined number
What is its role ?
To propose and discuss IMI orientations
To disseminate information on IMI implementation
Composition and expertise ?
Open to all stakeholders, venue size will determine
However, some quotas may be used to ensure a fair and balanced representation of all stakeholders groups
(e.g. SMEs, regulatory, patients, academic, …)

29. Other Governance aspects
Call processes and peer review
Guidelines for participation
Funding Processes

30. Call processes
and peer review

31. How to manage Call for Proposals ?
Question 1
How to manage Call for Proposals ?
The Executive office shall manage the calls for
proposals, the evaluation and selection of the
proposals, the establishment of the grants, the
follow up of the (rejected and selected) proposals
and the administration of the grants

32. How often will IMI issue a Call for Proposals ?
Question 2
How often will IMI issue a Call for Proposals ?
Hypothesis: IMI could issue 2 Calls per year
Flexibility to be kept regarding occurrence of unforeseen new emerging scientific issues
Calls may involve 2 stages (pre-proposals and full proposals)

33. How to evaluate proposals submitted to IMI ?
Question 3
How to evaluate proposals submitted to IMI ?
Proposals must be submitted to IMI in answer to
a Call for proposals
Proposals will be evaluated by a Peer Review
Committee and based on published evaluation criteria
The Peer Review Committee will submit a ranked list
of evaluated proposals to IMI Executive Office and
Executive Director

34. Guidelines for Participation

35. Will IMI-funded projects need to abide by the
Question 1
Will IMI-funded projects need to abide by the
FP7 « Rules for Participation » ?
As stated in the Commission proposal for the
Rules for Participation and Dissemination for the
FP7 (EC Treaty, recital 21), the future FP7 rules
for participation shall not apply to structure set up
on basis of article 171 of the Treaty
Therefore, the IMI Joint Undertaking (IMI) can
draw up and apply its own rules for participation,
including the rules for project costs reimbursement

36. Question 2:
Who can apply ?
The calls will be opened to all legal entities under
the condition that the research activities take place
within Europe (i.e. within the MS, CC and AS)
Legal entity can be SMEs, patients associations,
academic institutions, research institutes,
industries, …

37. Question 3:
How many partners ?
Hypothesis: an IMI research project must include
at least one EFPIA member (research performed
in Europe) and one European non-EFPIA member
(academic, SME, etc.) eligible for IMI funding
Legal entities participating within a Project must
be independent of each other, meaning they are not
subsidiaries of the same organisation or of each other

38. Funding processes

39. Will IMI-funded projects need to abide by the
Question 1
Will IMI-funded projects need to abide by the
FP7 « Financial Regulations » ?
IMI can adopt its own funding guidelines which
purpose is ensuring the sound and economic
financial management of IMI
The funding guidelines should respect the broad
principles and rules as laid down in the Financial
Regulation of 2002 applicable to the general budget
of the European Communities

40. Funding process for EU contributed participants?
Question 2:
Funding process for EU contributed participants?
As IMI shall act as a funding body, organisations
participating in IMI projects will not need to
submit separate applications to FP7

41. What about grant agreement?
Question 3
What about grant agreement?
A model Grant Agreement will be drawn up
by IMI JU, establishing rights and obligations of the
participants with regard to IMI
The Grant Agreement will be signed between the
IMI Joint Undertaking and the Project Consortium

42. Question 4: Who will pay for research costs ?
IMI Funding will be provided to all partners, except
Biopharmaceutical industry (EFPIA members) and other for profit organisations larger than SMEs that should carry their own costs
€ cash
€ cash
EU (FP7)
Industry
(EFPIA member)
IMI JU
€ in kind
(resources invested
in a project)
€ for IMI JU EO
€ for IMI research
Academic, SMEs,
Patient O., etc …
Industry
(EFPIA member)
IMI Research Project

43. Calculation of the financial industry contribution ?
Question 5:
Calculation of the financial industry contribution ?
Industry to present a detailed scheme
Industry contribution will be based on the prospective research expenditure occuring in Europe
Equal contribution of private and public funds

44. Flexibility of the equal repartition of funds
Question 6:
Flexibility of the equal repartition of funds
from EFPIA members and EC contribution
The industry contribution must match the
EU contribution to the IMI JU on a yearly basis

45. Will IMI funding provided to Public Bodies/HEIs/SMEs
Question 7:
Will IMI funding provided to Public Bodies/HEIs/SMEs
be limited to a maximum of 75% of full project costs
Point currently under discussion
Two important considerations:
IMI funding will concern « total eligible costs »
In conformity with « state aids rules »

46. Question 8:
Will EFPIA members provide Public Bodies/HEIs/SMEs participating in IMI projects with additional funding so that such parties can recover their full economic project costs (i.e. the “missing” 25%)
It is not envisaged within the frame of IMI

47. Will IMI have financial liability to the Community
Question 9
Will IMI have financial liability to the Community
with respect to FP7 funding awarded to IMI?
It would be foreseen that the financial liability
of the members of the Joint Undertaking
(EFPIA & the European Commission) for the debts
of the IMI Joint Undertaking shall be limited
to their contribution

48. Strategic Research Agenda

49. Who will approve updates of the SRA ?
Question 1
Who will approve updates of the SRA ?
The Board approve any amendment as
recommended by the Scientific Committee
that significantly changes the SRA

50. How to ensure synergies and avoid duplication
Question 2
How to ensure synergies and avoid duplication
between IMI and the other areas of the « Health »
cooperation pillar in FP7 ?
Role of the Programme Committee “FP7 Health”

51. Will IMI focus exclusively on translational research
Question 3
Will IMI focus exclusively on translational research
(i.e. only “validating” results of existing
academic research)
IMI will focus on any type of research necessary for the implementation of the IMI
scientific priorities

52. Intellectual Property Rights
See Chapter 7 of the SRA (also printed)
Please send us your questions

53. Next steps Next Meeting: Answer to further questions on IPR & on SRA
How to manage « Education and Training »