1. I M I The Innovative Medicines Initiative Member/Associated States Contact Group 20 March 2006

2. Innovative Medicines Initiative - IMI Objectives of today’s meeting -Provide information on the political process regarding FP7 and the establishment of Joint Technology Initiatives (JTIs) -Provide feed back on the progress of updating the Strategic Research Agenda of the Innovative Medicines Initiative -Present ideas of how the Innovative Medicines Initiative can be governed, and what IPR principles may apply

3. Agenda 11.00 Welcome and update on state of play Octavi Quintana-Trias, EC SRA -update 11.30 Feedback on SRA input Bernd Rainer, EC 12.00 New version of the SRA Karima Boubekeur, Roche 12.30 Discussion All 13.00 Lunch Proposed Governance structure and IPR principles 14.00 Governance structure Iréne Norstedt, EC 14.45 IPR principles Ulf Petrusson, Centre for Intellectual Property studies and Boo Edgar, Gothenburg International Bioscience Business School 15.30 Other issues Octavi Quintana-Trias, EC

4. The Political Situation FP7 The political situation Financial perspectives (agreement between the European Parliament and the Member States) 7th EU Research Framework Programme (Co-decision between the European Competitiveness Council and the European Parliament) 7th EU Specific Programme (Decision by the Competitiveness Council) The “Aho report” published January 2006

5. The Political Situation JTI’s Some European Technology Platforms may be proposed to be established as Joint Technology Initiatives via Art. 171 of the EC Treaty. Basis for decision: European added value Inability of existing instruments to achieve its objectives Degree and clarity of definition of objectives to be pursued Strength of financial/resource commitment by industry Contribution to broader policy objectives Scale of the impact on industrial competitiveness and growth Decision by the Competitiveness Council. JTI candidates: Innovative Medicines, Aeronotics, Hydrogen and Fuel Cells, Embedded systems, Nano electronics, GMES (Global Monitoring for Environment and Security)

6. Competitive Environment in the World It will be done… Innovative Medicines Initiative (EFPIA-European Commission) FDA Critical Path Initiative (NIH) Safe and Innovative Medicines (PhRMA) Biomarker Initiative (PhRMA) Critical Path Institute (University of Arizona) Center for Biomedical Innovation (MIT) Toxicogenomics Project (JPMA) Proteome Factory Consortium (JPMA) Large-scale Clinical Trial Network

7. Innovative Medicines Initiative - IMI Strategic Research Agenda -First draft SRA published on IMI website (July 2005) -Member States (MS) /Associated States (AS) invited to comment the proposed SRA (July-Oct 2005) -Consolidated comments received from ~ 50 % of the countries -EMEA’s Committee for Human Medicinal Products (HCMP) and Committee for Orphan Medicinal Products (COMP), both composed by Member states representatives) were invited to provide their comments -Some individuals and organisations has send comments -Some countries has provided supporting letters/messages

8. Innovative Medicines Initiative - IMI Strategic Research Agenda - Additional workshops were organised to reinforce the SRA in the following areas: -Pharmacovigilance (co-chaired by: Liz Swain, GSK and Panos Tsintis, EMEA) -Infectious diseases (chaired by: Rhino Rappuoli, Chiron) -SMEs and Finance (chaired by: Lars Sundstrom, Capsant Neurosciences) -New version of the SRA taking into account received comments will be published ~ April 2006

9. The InnoMed Project started November 2005 Consortium composed by 16 Companies – 14 Universities – 7 SMEs Predictive Toxicology –13 large Companies: Altana, Bayer, Boehringer-Ingelheim, Johnson & Johnson, Merck AG, Novartis, Novo-Nordisk, Organon, Roche, Sanofi-Aventis, Schering, Serono, Servier –3 Universities: University of Wuerzburg, Dublin and Hacettepe –1 SME: Genedata Biomarkers in Alzheimer’s Disease –3 large Companies: AstraZeneca, GSK, Lilly –11 Universities: King’s College London, University of Kuopio, Perugia, Stockholm, Toulouse, Karolinska, Southampton, Thesalonikki, Roskilde University, University College London, University of Lodz –6 SMEs: BioWisdom, Capsant, Cerebricon, Pharmidex, Proteome Sciences, Hunter Fleming

10. Innovative Medicines Initiative - IMI The Governance Taskforce has met regularly to define the proposed Governance structure and to draft the statues of the Innovative Medicines Initiative organisation. Composed by Industry and EC representatives. The IPR Taskforce has met regularly to define the proposed IPR principles Composed by representatives from Industry, Academia, SMEs and EC representatives.

11. Innovative Medicines Initiative - IMI Discussion on Host site postponed -Fear that the discussion on possible host site distracts from the KEY discussion on its objectives and research focus -Complex political situation – Financial Perspectives → reduced EU budget → delayed FP7 decision and reduced FP7 budget -Further development of JTI concept (s) - similarities and differences between the proposed JTI’s