The European Commissions Health Research policy and the Seventh Framework Programme

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The European Commissions Health Research policy
and the Seventh Framework Programme
Iréne Norstedt Health Research Directorate, DG
Research European Commission
Tel Aviv 19 September 2005
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Why research at European level?

• 3 main reasons
• Pooling and leveraging resources
• Fostering human capacity and excellence in ST
• Better integration of European RD

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Why research at European level?

• Pooling and leveraging resources
• Resources are pooled to achieve critical mass
• Leverage effect on private investments
• Interoperability and complementarity of big
  science

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Why research at European level?

• 2. Fostering human capacity and excellence in ST
• Stimulate training and international mobility of
  researchers
• Improve ST capabilities
• Stimulate competition in research

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Why research at European level?

• 3. Better integration of European RD
• Create scientific base for pan-European policy
  challenges
• Encourage coordination of national policies
• Effective comparative research at EU-level
• Efficient dissemination of research results

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Significant impacts of FPs on ST and the economy

• Economic benefits. 1 (research) at European
  level ? 4-7 (long-run, econometric models).
  Enterprises participating in FP benefit of
• reduced commercial risk
• increased turnover and profitability
• enhanced productivity and market share
• Innovative performance. Enterprises participating
  in FP
• tend to be more innovative
• more likely to patent
• engage in innovative cooperation with other firms
  and universities
• Scientific performance
• FP project ? up to 9 peer reviewed publications
  (international co-publications)
• Human resources development
• Over 7000 proposals for Marie Curie in 2004,
  thousands of researchers have participated in top
  trans-national teams, benefiting from training
  and knowledge sharing

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Projected FP7 economic impact (by 2030, as
compared to a business-as-usual scenario)
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Whats new in FP7?

• Main new elements of EC proposal compared to FP6
• Annual budget doubled (EUR 5 billion ? 10
  billion)
• Basic research ( EUR 1.5 billion per year)
• Simplification of procedures
• Logistical and administrative tasks transferred
  to external structures

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Specific Programmes
FP7 2007 - 2013
Cooperation Collaborative research
Ideas Frontier Research
People Human Potential
Capacities Research Capacity

JRC (non-nuclear)
JRC (nuclear)
Euratom
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FP7 budget(EUR billion, 2004 constant prices)
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Cooperation Collaborative research

• 9 Thematic Priorities
• Health
• Food, agriculture and biotechnology
• Information and communication technologies
• Nanosciences, nanotechnologies, materials and new
  production technologies
• Energy
• Environment (including climate change)
• Transport (including aeronautics)
• Socio-economic sciences and the humanities
• Security and space
• Euratom Fusion energy research, nuclear
  fission and radiation protection

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• Thematic Priority 1 Health

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Thematic priority (Health)

• Support will be implemented across all themes
  through

Collaborative research (Collaborative projects
Networks of Excellence Coordination/support
actions)
Joint Technology Initiatives
Coordination of non-Community research
programmes (ERA-NET ERA-NET Article 169)
International Cooperation

• Under each theme there will be sufficient
  flexibility to address both Emerging needs and
  Unforeseen policy needs
• Dissemination of knowledge and transfer of
  results will be supported in all thematic areas

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Health collaborative research

• Objectives / policy drivers
• Improving the health of European citizens
• Increasing the competitiveness of European
  health-related industries and businesses
• Addressing global health issues, including
  emerging epidemics

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Health collaborative research
Rationale for pan-European approaches (I)

• Sequencing of human genome and recent advances in
  post-genomics c vast amounts of data c new
  knowledge
• Translational research (translation of basic
  discoveries in clinical applications) c
  multidisciplinarity
• Clinical research c international multi-centre
  trials
• health policy-driven research c comparisons of
  national models data

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Health collaborative research
Rationale for pan-European approaches (II)

• Strong EU-based biomedical and research
• to strengthen the competitiveness of large
  industries (pharma) as well as SMEs (healthcare
  biotech medical technology).
• Trans-national cooperation is essential to face
  worldwide competition.
• contribute to the development of new norms
  standards to establish legislative framework for
  new medical technologies (e.g. in regenerative
  medicine), which is essential for industry.

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Health collaborative research

• Activities c 3 pillars in FP7
• Biotechnology, generic tools and technologies for
  human health
• Translating research for human health
• Optimising the delivery of healthcare to European
  citizens

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Health collaborative research

• Pillar 1 Biotechnology, generic tools and
  technologies for human health
• High-throughput research
• Detection, diagnosis and monitoring.
• Innovative therapeutic approaches and
  Intervention
• Predicting suitability, safety and efficacy of
  therapies (incl. alternatives to animal
  testing)

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Health collaborative research

• Pillar 2 Translating research for human health
• Integrating biological data and processes
  large-scale data gathering, systems biology
• Research on the brain and related diseases, human
  development and ageing
• Translational research in infectious
  diseases(incl. antimicrobial resistance,
  HIV/AIDS, malaria, TB, SARS, etc.)
• Translational research in major diseases
  cancer, cardiovascular disease,
  diabetes/obesity rare diseases and other
  chronic diseases.

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Health collaborative research
Pillar 3 Optimising the delivery of health care
to European citizens

• Translating clinical outcome into clinical
  practice
• Quality, efficiency and solidarity of health
  systems including transitional health systems
  (i.e. health systems that are currently under a
  reform process)
• Enhanced disease prevention and better use of
  medicines
• Appropriate use of new health therapies and
  technologies

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Health collaborative research

• Two other strategic issues will be addressed
  across activities
• Child health
• The health of the ageing population

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Health collaborative research

• From FP6 FP7
• Continuity in research activities
• Less focus on genomics
• Emphasis on translational research
• Biomedical technology engineering re-introduced
• Health policy-driven research (public health) is
  strongly reinforced

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• Technology Platforms
• Joint Technology Initiatives

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Technology Platformsconcept

• Technology Platforms should
• Bring together all interested parties in a
  particular sector.
• The sector should be of strategic importance and
  contribute towards the EUs goals of
  knowledge-based growth, competitiveness
  employment.
• Foster effective public-private partnership and
  bring together key stakeholders, under the
  leadership of industry, around a shared vision
  for the development of the technologies
  concerned.
• Define research and technical priorities in the
  medium and long term.
• Commission services are closely monitoring
  developments and, where appropriate, using their
  recommendations

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Technology PlatformsImplementation
In FP7, the Research recommendations can be
implemented through - collaborative research,
for most Technology Platforms - Joint Technology
Initiatives (JTI), for a few selected
Technology Platforms
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Joint Technology Initiatives

• Criteria for choice
• Strategic importance
• Evidence of Market failure
• Significant Community added value
• Commitment of industry
• Inadequacy of existing instruments

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Joint Technology Initiatives
Global Monitoring for Environment and Security
Hydrogen and Fuel Cells
Aeronautics and Air Transport
Nanoelectronics
Innovative Medicines
Embedded systems
Other possible themes to be identified later
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Innovative Medicines Initiative (IMI)

• Starting point
• Drug development costs too much, takes too long
  and safety and efficacy are not always
  guaranteed.- Pharmaceutical industry, WHO, NICE,
  
• Poor access for patients delays, unfulfilled
  needs
• Tendency to delocalise RD from Europe
• EU RD policy drivers
• Competitiveness of industry
• Quality of life

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Innovative Medicines Initiative (IMI)

• Aim
• To remove major bottlenecks in drug development
  where research is the key.
• Long term objective
• To increase competitiveness of European pharma
  industry, and foster Europe as the most
  attractive place for pharmaceutical RD, thereby
  enhancing access of innovative medicines to the
  benefit of patients and society.

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Bottlenecks in drug development
Safety and Efficacy are main reason for failure
of new medicines
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Stakeholders confirmed RD bottlenecks
Source EFPIA 2005
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Innovative Medicines Initiative2 2 areas

• The SRA will address RD bottlenecks in 4 main
  areas
• Improved prediction early indications of
  safety.
• Improved clinical performance early indications
  of efficacy by use of biomarkers.
• Better knowledge management through collaboration
  breaking information barriers at the
  interfaces.
• Education and training leverage strengths and
  bridge gaps pre-clinical and clinical research
  and breaking barriers between disciplines.

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Innovative Medicines Initiative

• Progress to date
• Under the leadership of EFPIA, industry
  identified the bottlenecks with key stakeholders
  academia, regulatory agencies, patient
  organisations, clinical researchers, ethical
  experts, etc. (Nov.04)
• A Strategic Research Agenda was developed by
  panels of experts through a series of workshops
  (Feb.- July 05)
• Strategic Research Agenda (SRA) was published for
  open consultation (Aug.05)
  http//europa.eu.int/comm/research/fp6/index_en.cf
  m?p1_innomed

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Innovative Medicines Initiative

• Next steps
• Finalise SRA following open consultation.
• Develop governance structure
• Define appropriate legal entity, including
  governance rules and financial engineering
• Develop the modus operandi for legal entity
• Develop IPR rules to be applied by the research
  performers
• Obtain approval as part of FP7

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Perspectives for Health research in FP 7

• Budget increase from 600m/year to gt 1
  billion/year
• Collaborative research to continue
• Biotechnology, generic tools and technologies
• Translational research
• Optimising delivery of health care
• Joint Technology Initiative for Innovative
  Medicines