Transcript No Slide Title

IMI
Member States & Associates States
Contact Group
4th Meeting
European Commission
Brussels
23 November 2006
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IMI Member States Group meetings
18 May 2005 - Focus on the Strategic Research Agenda
27 September 2005 - Focus on the Strategic Research Agenda
and IMI-related activities in Member States
20 March 2006 - Focus on Governance and IPR issues,
+ comments on the Strategic Research Agenda
23 November 2006 – 4th Meeting: Focus on:
(i) Answers to questions about IMI addressed by Member
States to DG RTD
(ii) Presentation, comparison and discussion of
already existing IMI-like initiatives in Member States
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AGENDA
UPDATE ON IMI PROCESS
9:00
Objectives of the meeting & Update on IMI process
Octavi Quintana Trias, European Commission
9:30
Importance of IMI as a European initiative for EFPIA members
Karen Strandgaard, EFPIA
10:15
General discussion and answers to questions sent by Member States
Irène Norstedt, Philippe Cupers European Commission
13:00 - 14:00
LUNCH
EXAMPLES OF EXISTING NATIONAL PUBLIC-PRIVATE-PARTNERSHIP
14:00
Top Institute Pharma in the Netherlands
Pr. Daan Crommelin, Scientific Director, TI Pharma
14:45
Medicamentos Innovadores in Spain
Pr. Ferran Sanz, Universitad Pompeu Fabra, Barcelona
15:30
General discussion
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IMI management in DG RTD
Octavi QUINTANA TRIAS Director FP7 Theme 1 (Health)
Arnd HOEVELER Head of Unit F5 (Health Biotech)
Irène NORSTEDT Head of Sector – IMI Sector
Bernd RAINER Scientific Officer – IMI Sector
Philippe CUPERS Scientific Officer – IMI Sector
Hilde SOMERS Assistant – IMI Sector
Dagmar LAUBE-FRIESE, as of January 2007,
Scientific Officer (END) – IMI Sector
Pascale CID Scientific Officer – Unit F1 – partim IMI
Ole OLESEN Scientific Officer – Unit F3 – partim IMI
Magali POINOT Legal & Policy Officer – Unit B1 – partim IMI
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Some clarifications about IMI
 Achievements since last meeting
 Required documents, planned roadmap
 How to participate to IMI ?
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Achievements since last meeting
Work on IMI documents (both EC and EFPIA)
 Required legal documents: « IMI Legal Package »
 Elaborated Modus Operandi
Strategic Research Agenda (SRA) (EFPIA)
 Incorporated comments from Member States and
publication of the last version on the Web (EFPIA)
Communication (both EC and EFPIA)
 Meetings in Member States, in US (e.g. BIO 2006 in
Chicago) or at international organisations (e.g.
OECD)
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Roadmap for IMI
IMI “Legal Package”
Commission approval
Interservice Consultation
+ Translation
Submission to Council
Approval by Council
January 2007
est:February 2007
est:March 2007
ASAP
(latest: Autumn 2007)
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Documents required
IMI “Legal Package” required for
Council Regulation
 IMI Statutes
 Impact Assessment
Explanatory Memorandum
 Financial Fiche
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IMI Impact Assessment (I)
An Impact Assessment document will be provided by
Commission based on two reports:
 Assessment of IMI societal and economic effects
- to be done by an « Expert group », chaired by
Iain GILLESPIE, OECD
 Keys to success - to be done by Industry
Main issues to be addressed are:
 Market Failure
 Additionality
Deadline is January 2007
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IMI Impact Assessment (II)
Objectives to be addressed in the
« Assessment of IMI societal and economic effects”
 Analysis of the current situation of pharmaceutical
R&D in Europe
 Effect of public support to the pharmaceutical sector
from past European Framework Programmes
 The IMI initiative: public intervention through a JTI
 Economic and societal effects of the IMI initiative
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Host Site
Commission will propose
to have all JTIs,
including IMI,
located in Brussels
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Important to have IMI adopted
as soon as possible
 Keep mobilisation and momentum of stakeholders
(industry, academic, SMEs, patients organisations)
 Other initiatives of Public-Private Partnerships
start in US: e.g. « Biomarkers Consortium », funded
by FDA, fNIH, PhRMA
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Roadmap for IMI Joint Undertaking
Approval by Council
IMI Joint Undertaking
becomes an official legal entity
Materialise IMI Joint Undertaking
 Recruit Executive Director & staff of Executive Office
 Setting up the organisation
 Launch the first Call for Proposals ?
Timing: from Autumn 2007 to end 2007
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How to participate to IMI research projects
Key Principles
 IMI research projects will be opened to any
stakeholder (SMEs, academic, industry, patients
organisations, research institutes, …)
 Stakeholders will be able to participate to IMI
research projects by answering to an IMI Call for
Proposals, which will be public
 Proposals submitted to a Call will be evaluated based
on a peer-review process
 IMI will complement the other EU funding schemes
rather than compete with them
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Comparison with other research funding schemes in FP7
ERC Scheme
EU
 
€
€
 
€

Mainly EU individual
contracts

Academic
or SME

EU
€ FP7
Implementation
by ERC
Executive agency
€
IMI Scheme
EU
€ FP7
€
Classical Scheme
Industry
Direct
implementation
by Commission
€
   
  
EU Consortium
contracts
€ FP7


 
 
Consortium of
Academic/SME
+ Industry
€
EFPIA Members
Implementation
by IMI JU
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Scheme for IMI funding
€ cash
EU (FP7)
€ cash
IMI JU
€ for IMI JU EO
€ for IMI research
Academic, SMEs,
Patient O., etc …
Industry
(EFPIA member)
€ in kind
(resources invested
in a project)
Industry
(EFPIA member)
IMI Research Project
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Strategic Research Agenda
 Second version, including comments made by
Member States, has been put on the Web at:
http://www.efpia.org/4_pos/SRA.pdf
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