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IMI Member States Contact Group

Questions & Answers

European Commission

Brussels23 November 2006

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Concerns: IMI legal status IMI governance, structure and management Strategic Research Agenda (SRA)

Questions received fromMember States

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The way to IMIJoint Undertaking

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Stakeholdersdriven« Innovative Medicines »

European Technology Platform (ETP)

Consultation step

EC, EFPIA &Stakeholders

driven« Innovative Medicines Initiative »

Joint Technology Initiative (IMI JTI)

Conceptualisation step

Council driven« Innovative Medicines Initiative »

Joint Undertaking (IMI JU)

Legalisation step

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Definitions The Innovative Medicines Initiative

Joint Technology Initiative (IMI JTI)is a new research funding instrument characterized by a private/publicpartnership

The IMI Joint Undertaking (IMI JU)is the legal entity whose responsabilityis to implement IMI JTI

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Innovative Medicines InitiativeJoint Undertaking (IMI JU)

BoardExecutive

OfficeScientific

Committee

Stakeholder’sForum

MemberStates Group

Innovative Medicines InitiativeJoint Technology Initiative (IMI JTI)

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IMI legal status

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« A Joint Undertaking on the basis ofArticle 171 of the Treaty»

Article 171: « The Community may set up jointundertakings or any other structure necessary for the

efficient execution of Community research, technological developments and demonstration

Programmes »

Question 1:What form of legal entity for IMI:

European Economic Interest Group (EEIG)? Foundation? Executive Agency?

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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

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Article 172: « The Council, acting by qualified majorityon a proposal from the Commission and after consulting

the European Parliament and theEconomic 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

Question 2:How and by who will this Joint Undertaking be adopted?

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Yes: Funds from EU to the IMI Joint Undertaking forresearch projects as well as for part of the runningcosts of the « Executive Office » will be providedthrough FP7

Therefore: FP7 adoption is crucial for IMI IMI EU funding is planned for the duration

of FP7 (till 2013)

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)

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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 rangeof € 100 mil and gradually increase to reach€ 300 mil at the end of the period

EC contribution should be matched by industrycontribution

Question 4:What is IMI share of FP7 ?

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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

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Member States will not be asked to directlycontribute financially to IMI JU

However, contributions at national level areessential for « mirror activities » at MemberStates level, as well as for the implementationof the « Education & Training » pillar of the SRA

Question 6:What will be the additional share

of the Member States to IMI ?

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IMI governance, structure& management

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

Governance principles

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Your questions related to the Board

Q1: Composition of the Board & Chair ?

Q2: Membership of new funding members ?

Q3: How do they make decisions ?

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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

EC EFPIA

Board

Alternate yearly Chair Meets twice a year

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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

Executive Office

Recruited by IMI JU Work full time for IMI JU ……............

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Executive Office

……............

The costs for running the “Executive Office”shall be covered in cash by EFPIA and EUon an equal basis

Additional QuestionWho will support IMI running costs?

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Your questions related to theScientific Committee

Q1: Composition & procedure for nomination

Q2: Clarification on the role

Q3: How is it done elsewhere?

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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

15 members

Scientific Committee

Chair elected for 2 years Meets four times a year

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Your questions related to theMember States Group

Q1: Composition & procedure for nomination

Q2: Clarification on the role

Q3: How is it done elsewhere?

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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

MS, CC, AC

Member States Group

……............

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Member States Group

……............

Pure national activities and the related costs shouldbe assumed by the Member States

Additional Question 1Will IMI provide funds to Member States to undertake

activities such as organising nationalinformation meetings

MS, CC, AC

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Member States Group

……............

Additional Question 2Clarification 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 financialinvolvement ?

MS, CC, AC

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Your questions related to theStakeholders’ Forum

Q1: Selection criteria ?

Q2: How many people ?

Q3: Nature of the fields/area to be covered ?

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undefined number Open Forum Convenes once a year

Stakeholder’s Forum

……............

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, …)

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Other Governance aspects

Call processes and peer review

Guidelines for participation

Funding Processes

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Call processesand peer review

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The Executive office shall manage the calls forproposals, the evaluation and selection of theproposals, the establishment of the grants, thefollow up of the (rejected and selected) proposalsand the administration of the grants

Question 1How to manage Call for Proposals ?

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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)

Question 2How often will IMI issue a Call for Proposals ?

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Proposals must be submitted to IMI in answer toa Call for proposals

Proposals will be evaluated by a Peer ReviewCommittee and based on published evaluation criteria

The Peer Review Committee will submit a ranked listof evaluated proposals to IMI Executive Office andExecutive Director

Question 3How to evaluate proposals submitted to IMI ?

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Guidelines for Participation

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As stated in the Commission proposal for theRules for Participation and Dissemination for theFP7 (EC Treaty, recital 21), the future FP7 rulesfor participation shall not apply to structure set upon basis of article 171 of the Treaty

Therefore, the IMI Joint Undertaking (IMI) candraw up and apply its own rules for participation,including the rules for project costs reimbursement

Question 1Will IMI-funded projects need to abide by the

FP7 « Rules for Participation » ?

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The calls will be opened to all legal entities underthe condition that the research activities take placewithin Europe (i.e. within the MS, CC and AS)

Legal entity can be SMEs, patients associations,academic institutions, research institutes,industries, …

Question 2:Who can apply ?

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Hypothesis: an IMI research project must include at least one EFPIA member (research performedin Europe) and one European non-EFPIA member(academic, SME, etc.) eligible for IMI funding

Legal entities participating within a Project mustbe independent of each other, meaning they are notsubsidiaries of the same organisation or of each other

Question 3:How many partners ?

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Funding processes

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IMI can adopt its own funding guidelines whichpurpose is ensuring the sound and economicfinancial management of IMI

The funding guidelines should respect the broadprinciples and rules as laid down in the FinancialRegulation of 2002 applicable to the general budgetof the European Communities

Question 1Will IMI-funded projects need to abide by the

FP7 « Financial Regulations » ?

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As IMI shall act as a funding body, organisationsparticipating in IMI projects will not need tosubmit separate applications to FP7

Question 2:Funding process for EU contributed participants?

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A model Grant Agreement will be drawn upby IMI JU, establishing rights and obligations of theparticipants with regard to IMI

The Grant Agreement will be signed between theIMI Joint Undertaking and the Project Consortium

Question 3What about grant agreement?

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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

Question 4: Who will pay for research costs ?

IMI JU

€ cash € cash

Academic, SMEs,Patient O., etc …

Industry(EFPIA member)

IMI Research Project

€ in kind(resources investedin a project)

Industry(EFPIA member)

EU (FP7)

€ for IMI JU EO

€ for IMI research

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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

Question 5:Calculation of the financial industry contribution ?

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The industry contribution must match the EU contribution to the IMI JU on a yearly basis

Question 6:Flexibility of the equal repartition of funds

from EFPIA members and EC contribution

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Point currently under discussion

Two important considerations:

IMI funding will concern « total eligible costs »

In conformity with « state aids rules »

Question 7:Will IMI funding provided to Public Bodies/HEIs/SMEs

be limited to a maximum of 75% of full project costs

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It is not envisaged within the frame of IMI

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%)

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It would be foreseen that the financial liabilityof the members of the Joint Undertaking(EFPIA & the European Commission) for the debtsof the IMI Joint Undertaking shall be limitedto their contribution

Question 9Will IMI have financial liability to the Community

with respect to FP7 funding awarded to IMI?

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Strategic Research Agenda

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The Board approve any amendment asrecommended by the Scientific Committeethat significantly changes the SRA

Question 1Who will approve updates of the SRA ?

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Role of the Programme Committee “FP7 Health”

Question 2How to ensure synergies and avoid duplication

between IMI and the other areas of the « Health »cooperation pillar in FP7 ?

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IMI will focus on any type of research necessary for the implementation of the IMIscientific priorities

Question 3Will IMI focus exclusively on translational research

(i.e. only “validating” results of existingacademic research)

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Intellectual Property Rights

See Chapter 7 of the SRA (also printed)

Please send us your questions

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Next steps

Next Meeting:

Answer to further questions on IPR & on SRA

How to manage « Education and Training »