Ole Olesen Health Directorate, DG Research European Commission

1. Ole Olesen Health Directorate, DG Research European Commission 3 July 2007

2. Content • The Health Theme (structure, activity areas) • Eligibility, evaluation, funding • First calls: trends and topics

3. The Health Theme

4. Collaborative researchin Health in FP7 The core objectives for Health research in FP7 are“improving the health of the European citizens and increasing the competitiveness of the European health related industries and businesses…”with emphasis on“translational research”. Budget: • €6 billion over 7 years (2007-2013)

5. Health research theme 1 in FP7 NEW! Pillar 1: Biotechnology, generic tools and medical technologies for human health Pillar 2: Translating research for human health Pillar 3: Optimising the delivery of health care to European citizens Funding schemes targeted at Small and Medium-sized Enterprises Child Health Health of the Ageing population Funding schemes targeted at International Cooperation: SICA

6. Scope of Collaborative Health Research: To support basic and applied collaborative research, including discovery activities, translational research and early clinical trials What’s new in Collaborative Research in Health in FP7? • Budget increase: €600m to ~ €900m per year • Continuity in themes and instruments • Continued SME focus • Less focus on genomics • Emphasis on translational research • Re-introduction of biomedical technology & engineering • Joint Technology Initiatives: Innovative Medicines Initiative • New focus on International Cooperation • New pillar: Public Health and Health system research

7. Innovative Medicines Initiative- Background Economical and structural challenges to European pharma R&D: Increasing development costs, increasing failure rates, expatriation, lower public spending and private investments than other regions. Consultations with more than 300 experts and key stakeholders (Pharma Industry, SMEs, patients, regulators, clinical and academic researchers, etc.). Identification of 4 key areas for R&D: • Predictive safety • Predictive efficacy • Knowledge management • Education and training The aim of the Innovative Medicines Initiative (IMI) is to address these 4 key areas

8. Innovative Medicines Initiative- Implementation • The Innovative IMI is proposed as a Joint Technology Initiative (JTI) under FP7 • A new, independent legal structure – a Public Private Partnership – will be set up by the EC and EFPIA. • Location, Governance structure, IPR and financial rules to be decided. • Tentative initial budget of € 2 Bn – equally from EC and Pharma Industry (in kind or cash) - and potentially other stakeholders • Activities through open calls for tenders – many of interest for Academia/SMEs • IMI will complement and/or replace collaborative research activities in key areas (predictive safety, toxicology and efficacy)

9. Next steps for IMI • Develop governance structure: legal entity, financial engineering, governance rules, IPR rules… • Obtain approval for IMI as joint undertaking (Art. 171) through a Council decision. • The Commission proposal has been completed, and is now discussed in the Council research group • Develop annual Work Programme from Strategic Research Agenda • Pending favorable decision by the European Council of Ministers, IMI could become operational by late 2007

10. Increased International participation in Health research 245 participants from 51 third countries in FP6

11. International Collaboration in FP7 Two different avenues: 1. All activities open for International Cooperation • International Cooperation Partner Countries (ICPCs) can participate in projects and receive EC funding • Minimum number of participants: 3 from MS/AS 2. Specific International Cooperation Actions • Address specific issues of partner countries or with a global character, on the basis of mutual interest and benefit • Minimum number of participants: 2+2 (2 from MS/AS + 2 from ICPCs)

12. International Collaboration What is new in FP7? • The management of thematic INCO projects moves from the INCO directorate to the thematic directorates INCO-Health to Health Research • better synergies with traditional collaborative projects in the theme • greater visibility for INCO projects (now called SICA) as part of a larger portfolio

13. Infectious diseases in FP7Extended disease focus • Poverty-related diseases: • HIV/AIDS • Malaria • TB • Neglected tropical diseases • Emerging infectious diseases: • Influenza • Hepatitis • Anti-microbal resistance NEW

14. Theme 3: Health Care Delivery • 3:Optimising the delivery of health care • Enhanced health promotion and disease prevention providing evidence of best public health measures – life styles, interventions, special focus on mental health, etc. • Translating clinical research into clinical practicepatient safety, better use of medicines, benchmarking, pharmacovigilance, etc. • Quality, solidarity and sustainability of health systems organisational and financial aspects, health systems, etc.

15. Call Topics in:Delivery of Health Care • Implementation of research into healthcare practice (FRP) • Self-medication and patient safety (FRP) • Improving clinical decision making (FRP) • Better use of medicines (FRP) • Continuity of clinical care (FRP) • Patient self-management of chronic disease (FRP) • Evaluation of disease management programmes (FRP) • Mobility of health professionals (FRP) • Clinician worktime and patient safety (FRP) • Trends of population health (FRP) • Promoting healthy behaviour in children and adolescents (FRP) • Interventions addressing the gradient of health inequalities (FRP) • Public health interventions addressing the abuse of alcohol (FRP) • Evaluation of suicide prevention strategies across Europe (FRP)

16. Application process • ELIGIBILITY • EVALUATION • FUNDING

17. Europe enlarges • EU-27: • Austria • Belgium • Denmark • Finland • France • Germany • Greece • Ireland • Italy • Luxembourg • Netherlands • Spain • Sweden • Portugal • UK • Cyprus • Estonia • Hungary • Latvia • Lithuania • Malta • Poland • Czech Republic • Slovenia • Slovakia • Romania • Bulgaria • Candidate countries • Turkey • Croatia • FYR Macedonia Minimum: 3 MS/AS • Associated countries • Norway • Switzerland • Iceland • Israel

18. Funding Instruments in FP7? Funding instruments: Integrated Projects Integrating Projects (IP) (6-12 M EUR) STREP Projects Focused Research Projects (FRP) (max 3 M EUR) Networks of Excellence Networks of Excellence (NoE) Coordination action Specific Support Action Coordination and Support Action (CSA) More flexible financing combinations - co-financing, RSFF, PPPs, IMI, EDCTP - EC funding to leverage other R&D investments

19. Simplified Evaluation in FP7 Only 3 criteria for peer-evaluation: Scientific Excellence(Quality of objectives and concept, state of the art) Impact(Expected impact as set out in work programme, dissemination activities and IPR management) Implementation(competence of partners, quality of the consortium (complementarity), managerial approach, allocation and justification of resources (budget, staff, equipment) Ethical review of original proposal: No possibility to submit additional ethical information between scientific and ethical review

20. 1-3rd Call for proposals: Health theme • First calls for proposals: • first deadline: 17 April ’07; budget of €622 million • Received 914 proposals • Imbalance of small/large projects 60/40 % 2nd Deadline: • second deadline: 18 September ’07; budget €538 million • 3rd Deadline: • New Work programme to be drafted: Autumn 2007 • Publication: Q2, 2008 ? • Likely to focus on larger projects

21. FP7: main new elements • Longer duration (7 years) – larger budget + 40% annually • European Research Council (Ideas programme ) ERC • Collaborative research (Cooperation ) • continuity in themes & instruments. • Focus on both basic and translationalresearch • Increased focus on international cooperation • funding levels to be raised in some cases (SME) 50%  75% • Joint Technology Initiatives, egg: the Innovative Medicines Initiative IMI • Infrastructures, SME, regions & potential (Research Capacities ) • Human potential and science careers (People )

22. Health Research: Continuity of Challenges in FP7 • Longer duration - larger budget • Continuity from FP6 (pipeline approach) • Focus on product development (translational) • Focus on collaborative research • Focus on European and global health problems • Create Partnerships • Between scientists from different disciplines • Between scientists from different countries • Between different sectors: Industry-academia

23. Thank You