Towards the Seventh Framework Programme

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• Ole Olesen
• Health Directorate, DG Research
• European Commission

3 July 2007
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Content

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

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The Health Theme
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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)

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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
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Whats 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

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Innovative Medicines Initiative- Background

• Economical and structural challenges to European
  pharma RD 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 RD
• Predictive safety
• Predictive efficacy
• Knowledge management
• Education and training
• The aim of the Innovative Medicines Initiative
  (IMI) is to address these 4 key areas

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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)

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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

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Increased International participation in Health
research
245 participants from 51 third countries in FP6
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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 22 (2 from
  MS/AS 2 from ICPCs)

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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

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Infectious diseases in FP7Extended disease focus
Poverty-related diseases HIV/AIDS Malaria TB Ne
glected tropical diseases
Emerging infectious diseases Influenza Hepatitis
Anti-microbal resistance
NEW
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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
  practice patient safety, better use of
  medicines, benchmarking, pharmacovigilance, etc.
• Quality, solidarity and sustainability of health
  systems organisational and financial aspects,
  health systems, etc.

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Call Topics inDelivery 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)

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Application process

• ELIGIBILITY
• EVALUATION
• FUNDING

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Europe enlarges

• EU-27
• Austria
• Belgium
• Denmark
• Finland
• France
• Germany
• Greece
• Ireland
• Italy
• Luxembourg
• Netherlands
• Spain
• Sweden
• Portugal
• UK
• Cyprus
• Estonia
• Hungary

Minimum 3 MS/AS

• Associated countries
• Norway
• Switzerland
• Iceland
• Israel

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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 RD investments
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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

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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

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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 )

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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

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Thank You