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

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

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

7. IMI legal status

8. 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. 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. 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 2007-2013 (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. EU FP7 € 50.5 bil “Cooperation” Pillar € 32.3 bil “Health” Theme € 6 bil IMI € 1 bil Question 5: Where will the budget come from in FP7 ?

14. 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. 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 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 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 • 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. 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. 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. 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. 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. 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 guidelinesshould 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. 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. 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. Academic, SMEs, Patient O., etc … Industry (EFPIA member) IMI Research Project 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

43. 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. 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. 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. 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. 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. 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”