imi member states contact group questions & answers european commission brussels 23 november...
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IMI Member States Contact Group Questions & Answers European Commission Brussels 23 November 2006. Questions received from Member States. Concerns: IMI legal status IMI governance, structure and management Strategic Research Agenda (SRA). The way to IMI Joint Undertaking. - PowerPoint PPT PresentationTRANSCRIPT
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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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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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« 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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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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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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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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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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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