EHFG 7 October 2005 – Patient Safety & Research UK Presidency Workshop on Patient Safety, EHFG, Bad Hofgastein,7 September 2005 Kevin McCarthy, European Commission Health Research Directorate, DG Research, EU Research and Patient Safety

EHFG 7 October 2005 – Patient Safety & Research Deliberations at the European level - HLG Research support to operational / policy services FP6 - Scientific Support to Policy  emphasis on patient mobility and quality issues: SSP projects: E4P & MARQUIS … Experience from current and completed projects – Internal Market (4FP), REBEQI, QM in Health (5FP) Deliberations at the international & regional levels – World Alliance, WHO/EURO work The next FP … Factors influencing such research in the European context: Patient Safety Research & Europe

EHFG 7 October 2005 – Patient Safety & Research Europe is a natural laboratory Critical mass on best practice Health policy-driven research  allows comparisons of national models & data Experience at the international level A pan-European approach : Patient Safety Research & Europe

EHFG 7 October 2005 – Patient Safety & Research  Health  Food, agriculture and biotechnology  Information and communication technologies  Nanosciences, nanotechnologies, materials and new production technologies  Environment (including climate change)  Socio-economic sciences and the humanities The Patient & FP7 ( )

EHFG 7 October 2005 – Patient Safety & Research Collaborative research (Collaborative projects; Networks of Excellence; Coordination/support actions) 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) 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 Support will be implemented across all themes through: Health Research Theme

EHFG 7 October 2005 – Patient Safety & Research HEALTH THEME - COLLABORATIVE RESEARCH Objective: Improving the health of European citizens Increasing the competitiveness of European health-related industries and businesses Addressing global health issues including emerging epidemics

EHFG 7 October 2005 – Patient Safety & Research Activities  3 Pillars Biotechnology, generic tools and technologies for human health Translating research for human health Optimising the delivery of health care to European citizens FP7 HEALTH RESEARCH

EHFG 7 October 2005 – Patient Safety & Research Third Pillar: Optimising the delivery of health care to European citizens I. Enhanced health promotion and disease prevention II. Translating clinical research into clinical practice III. Quality, solidarity and sustainability of heath systems FP7 & PATIENT SAFETY

EHFG 7 October 2005 – Patient Safety & Research I. Enhanced health promotion & disease prevention: Provide evidence for the best public health measures in terms of life styles and interventions - different levels & different contexts Focus on the wider determinants of health and how they interact at both the individual and community level: – For example diet, stress, tobacco and other substances, physical activity, cultural context, socio-economic and environmental factors. Mental health to be addressed in a life-course perspective FP7 & PATIENT SAFETY

EHFG 7 October 2005 – Patient Safety & Research II. Translating clinical research into clinical practice: Better use of medicines, and appropriate use of behavioural and organisational interventions and health therapies and technologies Special attention paid to patient safety: – to identify the best clinical practice – to understand decision making in clinical settings in primary and specialised care – to foster applications of evidence-based medicine and patient empowerment Focus the benchmarking of strategies; investigating outcomes of different interventions including medicines, taking into consideration pharmacovigilance evidence, specificities of the patient (e.g. genetic susceptibility, age, gender and adherence) and cost benefits FP7 & PATIENT SAFETY

EHFG 7 October 2005 – Patient Safety & Research III. Quality, Solidarity and sustainability of health systems: Basis for countries to adapt their health systems National contexts and population characteristics taken into account Organisational, financial and regulatory aspects Implementation Outcomes - effectiveness, efficiency and equity Special attention on investment issues and human resources FP7 & PATIENT SAFETY

EHFG 7 October 2005 – Patient Safety & Research  Innovative Medicines Long term objective: To increase the competitiveness of the European Pharmaceutical industry, and to foster Europe as the most attractive place for pharmaceutical R&D. Thereby enhancing access of innovative medicines to the benefit of patients and society. Aim: To remove major bottlenecks in the drug development process, as identified by industry, and where research is the key. Joint Technology Initiative

EHFG 7 October 2005 – Patient Safety & Research Innovative Medicines Initiative  Industry (under the leadership of EFPIA) has identified the bottlenecks in agreement with key stakeholders: academia, regulatory agencies, patient organisations, clinical researchers, ethical experts, etc.  A Strategic Research Agenda prioritising the research needs and how they should be implemented has been developed by panels of experts:  Prediction of safety  Earlier indication of efficacy  Knowledge management  Education & training

EHFG 7 October 2005 – Patient Safety & Research  Domains identified by the HLG:  Financial costs and benefits of implementing improved systems – inter-relationships, economic analysis  Contribution to design for safety – SMEs are innovative  Networking – ERA-Net tool  New knowledge and better understanding e.g. magnitude and quality of adverse events outside the hospital setting  Engaging with the patient, with society – communication  Links to international and regional developments – World Alliance, WHO Potential areas: Patient Safety Research (i) :

EHFG 7 October 2005 – Patient Safety & Research  Major scientific conference and public health intervention research – a 6th FP SSP initiative: 5th Call  FP7 - A health systems approach with appropriate methodologies being developed:  epidemiology of adverse events - identification, measurement, frequency, causes, determinants, and impact on patient outcomes  effective methods for preventing such events;  optimizing patient safety, best practice  Evidence-based medicine  Contributions from IT, nanotechnologies Potential areas: Patient Safety Research (ii) :

EHFG 7 October 2005 – Patient Safety & Research Information EU research: Seventh Framework Programme: _en.cfm Information on research programmes and projects: RTD info magazine: Information requests: