EU Gap analysis for Health Economics Research

Transcription

1 EU Gap analysis for Health Economics Research Evers + Manders Susbsidieadviseurs d.d. 26 september 2012 dr. Flipsen

2 Table of Content Goal... 3 Scope... 3 Programs... 3 Fields... 4 Search methodology... 5 Result table format... 6 Results Phase 1 Analyses of the programs and calls... 7 Conclusion... 9 Sources Appendixes Page 2

3 Goal Cost reduction can only be achieved if costing characteristics are incorporated in health research. In order to obtain insight in the current state of this topic a status overview and gap analysis over the major Research programs of the last years has to be carried out. Scope Programs The calls for following programs Incorporated in this first survey: 7 th framework Research and development program: Cooperation themes: Health Food, agriculture etc. Information and communication Nanosciences, materials etc. Environment Socio economic sciences and humanities ERA NET People, Initial Training Networks and Industrial Academic Partnerships and Pathways Ideas EAHC 2 nd framework program of the Executive Agency for Health and Consumers Eureka (no cluster or umbrella projects found) Ambient Assist Living IMI (Innovative Medicines Initiative) European Innovation Partnerships (EIP) For instance Active and Healthy Ageing Other EU initiatives For instance Guardian Angels National Institute of Health (US) Page 3

4 Fields Healthcare fields covered: Detection Diagnosis and monitoring (fp7 health 1.2) Suitability, safety, efficiency of therapies (fp7 health 1.3) Innovative, Therapeutic approaches and Interventions (fp7 health 1. 4) Research on the brain (fp7 health 2.2) Infectious diseases (fp7 Health 2.3) Cancer (fp7 health 2.4.1) Cardio vascular (fp7 health 2.4.2) Diabetes and Obesity (fp7 health 2.4.3) Rare Diseases (fp7 health 2.4.4) Other Chronic Diseases (fp7 health 2.4.5) Translating clinical research in to practice (fp7 health 3.1) Health care systems (fp7 health 3.2) Health promotion and prevention (fp7 health 3.3) International public health & health systems (fp7 health 3.4) Other actions across health theme (fp7 health 4) Fork to Farm: Food Health and well being: consumers (fp7 KBBE 2.2.1) geriatrics ICT for Health, Ageing Well, Inclusion and Governance (fp7 ICT 5) Ambient assist living (projects) Active and Healthy Ageing (EIP) Major trends in society and their implications (fp7 socio economics 8.3) Translating Research for human health (fp7 ERA NET ) Research on the brain and related diseases, human development and ageing (fp7 ERA NET ) Translational research in other major diseases (fp7 ERA NET ) Promote Health (2 ND fp health) 1 Orthopaedics 2 Psychology Health care fields that have no not obtained special attention in the research and care programs within this scope Page 4

5 Search methodology Within the scope as described above we will identify the calls and work programs with a the focus of cost efficiency. Key words to be used will be: cost, efficiency, benefit, saving, budget, Health economic The resulting calls will be analysed on their relevance for the project as focus on: cost efficiency, comparative, methodology and disease oriented, or health care system orientation The results will be presented in a table to identify the areas covered, to illustrate their relationship and identify the gaps in this. To make the information accessible and allow meta analysis we will make several results sheets to cluster the results to indicate the programs and the different relevance. In the appendix the identified calls have been collected to illustrate the scope of the European instruments in cost management of care. The search will comprise two phases: For the Phase 1 proposal, the focus will be limited to the activities of the EU. What attention is given by the EU in the composition of the HEALTH and other R&D programmes (i.e. an analysis of the calls) For the Phase 2 proposal, an inventory is proposed to gather the relevance of the projects submitted and granted and other activities executed within the EU R&D domain. Page 5

6 Result table format R&D Innovation Diagnosis Clinical research Field Brain Infection Cancer Cardio vascular Diabetes and obesities Rare disease Chronic disease Ageing Orthopaedics Psychology Program Year Topic Relevance Care prevention Systems and policy Total health system Page 6

7 Results Phase 1 Analyses of the programs and calls The detailed results are given in appendix 1 to 4. Appendix 1 gives an overview, the gap analysis. The appendix 2 to 4 give the call texts of the most relevant calls found in the 7 th Framework program on research and development, the 2 nd FP of the Executive Agency for Health and Consumers and from EU Ambient Assist Living program. There were also a number of US NIH projects identified that are relevant. The 7 th FP R&D cooperation theme Heath did contain a relevant section on program level, section 3 and especially section 3.2: The activity "Optimising the Delivery of Health Care to European Citizens" aims to ensure that the results of health research will ultimately reach European citizens. It will reinforce health policy driven research at the European level and in particular through benchmarking, comparisons and analysis of models, systems and data of national databases, will generate new knowledge to underpin informed policy decisions on the efficiency and responsiveness of health cares systems in Europe, and more effective strategies in health promotion, disease prevention, diagnosis and therapy. Furthermore, it will provide the scientific evidence needed to support the objectives of the proposed new Programme of Community Action in the field of Health ( )8. Research into the independence, life quality and mobility of the ageing population will be covered. In this section 3, 13 out of 31 relevant calls where found. 7 of these 13 calls where focussed on ICPC countries, aimed to help them to build their healthcare system. Most of the calls that do take the efficiency and cost effectiveness into account are focused on bringing innovations and new developments to the market, instead of evaluating the impact on healthcare costs in a systematic way. An example is the attention to the cost effectiveness of diagnosis for Cardio Vascular disease. They take in to account the effect of earlier diagnosis on the healthcare costs or patient wellbeing in comparison with other existing diagnosis. However, they do not take in to account the effect of earlier diagnosis on for instance treatment costs as more patients are diagnosed and treated. On the other hand, a large number (26) of studies on Health economics and cost effectiveness where focussed on a healthcare systems and policies. These include expert consultations, data collection, and comparison of strategies and policies at a high level. Economic efficiency and cost reduction in healthcare is a fragmented field. Most attention to this topic is given on the level of: total health system analysis, both for Europe and for ICPC countries. Next to this the topic of cost reduction is seen in health fields as: Ageing, Infections, Cardio vascular and Diabetes. Seen from the implementation side, most attention to health economics an cost reduction can be seen in: care, especially in regard to ageing Page 7

8 prevention, especially for infections System and policies especially for diabetes A number of calls may provide interesting data as they aim for: Comparison of care system and approaches Collect data on costs and efficiency Bring together high level expert groups Alternatively, there are a number of studies in the 7 th FP that are focused on reduction of costs for certain techniques to make them affordable. These are focussed on market introduction and not on healthcare costs thus ignored in this study. Page 8

9 Conclusion Coherence on health economics research Within the 7 th FP R&D program and the 2 nd FP EAHC there is attention to health economics and costefficiency. Although there is even attention to this topic at program level, there is no apparent integrated approach. Especially the impact of research, development, and innovation on the costs for healthcare system are hardly investigated. Most studies do not surpass the level of comparison with existing techniques and assume that they will only replace this technique in the market. Only in the fields of ageing and infectious disease there is some attention to this integrated approach as calls do demand research in to the impact on the total healthcare costs that can be expected from the implementation of research results. Fields with no or little attention on health economics As stated there is surprisingly little research on how upcoming research, development and innovation, even diagnostics, clinical research, pharmacology or changes in clinical or care practice may impact the total cost of healthcare. This can only be found in a limited way for infectious disease and ageing. An example of a non integrated approach can be seen in Cardiovascular disease as described in the results. Areas for improvement There is need for improvement in evaluation of potential health care costs in two ways: Attention to cost effects from implementation of results from research, development, innovation, diagnostics, clinical research, pharmacology to care that go beyond the stage of market replacement. The healthcare system approach remains too much focused at a strategy and policy level, where it could benefit from a better insight in what determines the costs for healthcare and how research and development could aid in reducing these costs. Although the programs do acknowledge the problem of increasing healthcare costs that are surpassing the available healthcare budgets, no integrated research is focused on the causes and solutions. As long as the research is focussed on reduction of costs driven by either strategies, systems and policies or research and innovation no insight or breakthrough can be expected in the ever increasing costs for healthcare as they fail to encompass the complete picture. The limited attention that is now focused at this integration should thus be expanded and coordinated to provide a basis for a new research program. Page 9

10 Sources 7 th EU FP on R&D nd EU FP From EAHC... EU AAL Programme... europe.eu/ European Innovation Partnerships (EIP) union/index_en.cfm?section=active healthy ageing National Institute of Health (US)... Page 10

11 Appendixes Appendix 1... Overview results phase 1 study Appendix 2... Identified calls from the 7th EU FP on R&D Appendix 3... Identified calls from the 2 nd EU FP EAHC Appendix 4... Identified calls from the EU AAL program Page 11

12 Appendix 1 overview results Field Program FP7 R&D 2011 Topic HEALTH : Understanding the role of Brain and nural neuroinflammation in disease neurodegenerative diseases. Relevance reduction of treatment costs R&D Innovation Diagnosis Clinical research Pharmacology Care prevention Systems and policy Program FP7 R&D 2009 Topic HEALTH : Clinical evaluation of point of care diagnostic tests for microbial detection and identification, antibiotic susceptibility determination and biomarkers. Relevance cost effectivenes Program EAHC 2nd FP 2009 Topic Improve rational use of antibiotics and fighting anti microbial and antiviral resistance Relevance cost benefit analysis of antibiotic resistance Program fp7 R&D 2013 Program FP7 R&D 2012 Topic HEALTH : Safety and Topic FP7 HEALTH : efficacy of therapeutic vaccines "The microbial challenge an Relevance Projects will demonstrate emerging threat to human health". that a therapeutic vaccine in the Relevance increased effectiveness envisaged area is superior to existing and/or cost savings or competing therapies under development, and that the expected cost medical benefits ratio meets public health needs Infection Program FP7 R&D 2007 Topic HEALTH : An integrated platform for development and clinical evaluation of point ofcare diagnostic devices for microbial detection, antibiotic susceptibility determination and biomarkers. Relevance cost effective diagnosis Program: IMI 2012 Topic benefit / risk vaccination Relevance Cancer Program FP 7 R&D 2010 Topic HEALTH : Predicting individual response and resistance to cancer therapy. Relevance providing more cost effective personalised therapies Program EAHC 2nd FP 2011 Program FP 7 R&D 2010 Topic HIV and co infections Topic HEALTH : prevention strategies concepts for Comprehensive control of Neglected the future Infectious Diseases (NID) Relevance benefit and effect of HIV Relevance cost saving in ICPC prevention strategies Program FP7 R&D 2007 Topic HEALTH : Improve vaccination coverage Relevance cost efficiency vaccination interventions Program FP 7 R&D 2009 Topic HEALTH : Human Papillomavirus Vaccination (HPV) and cervical cancer screening programmes: estimate of impact of different policy options by way of disease modelling and health economics. Relevance comparatieve study on (cost) effectivenes Cardio vascular Program fp7 R&D 2013 Topic HEALTH : Comparative effectiveness research of existing technologies for prevention, diagnosis and treatment of cardiovascular diseases. Relevance cost efficiency diagnostic technology Program: EAHC 2nd fp 2012 Topic Preventing chronicdiseases Relevance cost effectiveness of integrated approaches Diabetes and obesities Program fp 7 R&D 2011 Topic HEALTH : ERA NET on diabetes prevention and treatment Relevance attention to socioeconomics and publichealth costs Program NIH 2004 Topic IMPACT OF INTEGRATED HEALTH IT ON QUALITY AND RESOURCE USE FOR DIABETIC PATIENTS Relevance use of resouces after IT implementation Program NIH 2011 Topic BEST EVALUATION TOOLS & TECHNIQUES FOR EFFECTIVE RECOMMENDATIONS FOR POLICIES Relevance cost effectiveness and efficiency of Childhood diabetes programs Rare disease Chronic disease Program: EAHC 2nd fp 2012 Program EAHC 2nd fp 2012 Topic Preventing chronic Topic Nutrition and Overweight diseases Relevance Relevance cost effectiveness of integrated approaches Program EAHC 2nd 2012 Topic Cost effective policies chronic disease Relevance Program AAL 2008 Topic ICT based solutions for Prevention and Management of Chronic Conditions of Elderly People Relevance cost efficency of proposed measures Program fp7 R&D 2011 Topic HEALTH : Investigator driven clinical trials for therapeutic interventions in elderly populations. Relevance reduce healthcare cost Program AAL 2011 Topic ICT based Solutions for Advancement of Older Persons Mobility Relevance economic impact of proposed solution Program EAHC 2nd fp 2012 Topic Collection and dissemination of health information via cooperation with the Organisation for Economic Cooperation and Development Relevance Data collection and analysis Ageing Program FP7 R&D 2012 Topic HEALTH : Investigator driven clinical trials for optimisation of management of elderly patients with multiple diseases. Relevance comparative study a.o. lowering healthcare costs Program EIP 2012 Topic Active and Healthy Ageing Relevance improving the sustainability and efficiency of social and health care systems Orthopaedics Psychology Program FP7 R&D 2011 Topic ICT : Personal Health Systems Relevance evidence base on medical outcomes, economic benefits and effectiveness of the use of Personal Health Systems in evolved care models Program EAHC 2nd FP 2009 Topic Mental health Relevance economic mental health strategy

13 Appendix 1 overview results R&D Innovation Diagnosis Clinical research Pharmacology Care prevention Systems and policy Field Program FP7 R&D 2007 Topic HEALTH : Evaluation of disease management programmes Relevance evaluate large scale population based disease management programmes and their effect on cost Program FP7 R&D 2007 Topic HEALTH : European system of Diagnosisrelated groups (DRG). Relevance cost comparison Program FP7 R&D 2007 Program FP7 R&D 2009 Program EAHC 2nd FP 2007 Topic HEALTH : Better Topic HEALTH : Primary Topic Health impact and use of medicines care quality linkage to costs. health technology assessment Relevance cost effectiveness use of Relevance EU comparative study Relevance assesment of cost medicine primary care quality effect on cost efficency and economic impact of policies Program FP7 R&D 2011 Program FP7 R&D 2009 Program EAHC 2nd FP 2009 Topic HEALTH : Genome Topic HEALTH : Topic Investment in health based biomarkers for patient Healthcare outcomes and cost Relevance corrolation investment in stratification and benefits. health and economic growth pharmacogenomic strategies Relevance realtion between quality Relevance efficency of and cost efficiency pharmacotherapy Program FP7 R&D 2010 Program FP7 R&D 2013 Program FP7 R&D 2013 Program fp 7 R&D 2010 Topic HEALTH : Risk Topic HEALTH : Boosting the Topic HEALTH : Topic HEALTH : Financing adjustment algorithms for better translation of health research Comparative effectiveness research systems' effect on quality of health insurance coverage. projects' results into innovative (CER) in health systems and health healthcare. Relevance mechanisms to ensure applications for health. services interventions. Relevance help choose the right efficiency in the financing of social Relevance cost benefit analysis of Relevance Projects will evaluate financing mechanisms insurance based health care, open innivation from FP7 health program the impact of two or more health care for all alternative health system and health services interventions in terms of their health benefit, patient needs, patient safety, effectiveness and quality of care as well as cost effectiveness. Program FP 7 R&D 2010 Topic HEALTH : Develop and assess key interventions and policies to address the human resource crisis in the health sector. Relevance health related WHO Millennium Development Goals Program FP7 R&D 2010 Topic HEALTH : Financing models for accessible health care. Relevance reform existing financing systems for healthcare in middele income countries Program fp 7 R&D 2010 Topic HEALTH : Impact and cost effectiveness of existing major health programmes. Relevance provide evidence on the effectiveness, costeffectiveness and appropriateness of major health programmes in ICPC Total health system Program EAHC 2nd fp 2010 Topic Promoting health in all policies approach Relevance economic benefit of healthcare Program EAHC 2dn fp 2010 Topic Dissemination and application of health information, collecting, analysing and using health information at Community level Relevance data collection for leaga, economic and health impact for policy development Program EAHC 2fp 2011 Topic Research agenda for the EU on health economic evaluations Relevance WHO proposal for a priority agenda on EU health economic research Program NIH 2012 Topic ESTIMATING HOSPITAL OUTCOME QUALITY: APPLICATIONS TO PAY FOR PERFORMANCE Relevance cost quality comparison Program FP7 R&D 2012 Topic HEALTH : Improving the organisation of health service delivery Relevance efficiency of health care services Program FP7 R&D 2012 Topic SSH Coordinating research agendas on economic policy, prioritisation and coordination in Europe Relevance coordinating research agendas for macro economic studie of institutional and structural reforms Program fp7 R&D 2011 Topic HEALTH : Building sustainable capacity for research for health and its social determinants in low and middle income countries Relevance building capacity for health economic research Program EAHC 2nf FP 2012 Topic Indemnities to experts for advice on healthsystems Relevance expert penal on o.a. health economics Program EAHC 2nd FP 2012 Topic Commission membership fee to the European Observatory on Health Care Systems and Policies Relevance expertise network Program EAHC 2nd fp 2012 Topic Scientific and technical support to the EU Health Forum Relevance cost benfit on meta economic level leganda Collor scheme FP7 R&D Health FP7 R&D non health EAHC 2nd FP EU AAL EU EIP US NIH Extra relevant Program NIH Topic COMPARING THE EFFECTIVENESS OF MEDICATION USE SYSTEMS IN SMALL RURAL HOSPITALS Relevance improve the quality and efficiency of healthcare for those living in, and traveling through, rural America Program NIH Topic QUANTIFYING ELECTRONIC MEDICAL RECORD USABILITY TO IMPROVE CLINICAL WORKFLOW Relevance improve the quality, safety, efficiency, and effectiveness of healthcare for all Americans

14 Appendix 2 EU 7FP Research and Development Identified Calls on health cost, efficiency, savings, benefits and economics

15 Inhoud Health... 3 Not included but maybe relevant... 6 SOCIO ECONOMIC SCIENCES AND HUMANITIES Health... 8 SOCIO ECONOMIC SCIENCES AND HUMANITIES Health ICT Not included but maybe relevant Health SOCIO ECONOMIC SCIENCES AND HUMANITIES Not included but maybe relevant Health Health Not included but maybe relevant... 33

16 2013 Health HEALTH : Boosting the translation of health research projects' results into innovative applications for health. FP7-HEALTH-2013-INNOVATION-2. The main aim of this topic is to allow SMEs to take up health research outcomes resulting from earlier FP funding under FP7 Theme Health and FP6 Life sciences, genomics and biotechnology for health, to prove the viability of methodologies, processes, prototypes, models, technologies, clinical trials, etc. developed under these projects, with a potential for application. However, the consortium does not need to be the same as in the previously funded project, but include participants as appropriate to exploit those particular results in the most logic and efficacious manner. Research activities under this topic will focus on testing and validation of results in order to reach the final development stage before products or processes enter into production, reach the market and/or patients. Proposals will fit into the overall business and innovation needs of the partners involved and will demonstrate clear exploitation potential and socioeconomic benefits for the patients, for them and the society at large. Applicants should have the freedom to exploit the results for commercial use. Applicants will describe clearly and convincingly how the results, knowledge and/or technology will be brought forward enough to reach the stage of application. Note: Limits on the EU financial contribution and project duration will apply and will be implemented strictly as eligibility criteria. Funding scheme: Collaborative Project (small or medium-scale focused research project) One or more proposals may be selected. Expected impact: Translation of high level scientific knowledge into applications and innovative products and services. Considering the specificities of the economic sectors falling under this activity of Theme Health, projects funded under this topic are expected to pave the way from the development of scientific knowledge and technologies to the market by stimulating the development of new products, tools, technologies, patents, dedicated business path and innovative marketable applications. Specific requirements to be considered under the evaluation: Specific innovation initiative designed to encourage strong SME efforts towards the translation of research results into innovative applications for health. Leading role of SMEs in the project (see also section III, p.65 of this document). Developing a short business plan clearly describing the valorisation of the technology(ies) when presenting a full proposal for stage 2. Expected outcomes being of clear interest and potential benefit to SME(s). Additional eligibility criteria: 1. The requested EU contribution per project will depend on the needs of the project indicated in the proposal but shall not exceed EUR The proposed project duration indicated in the proposal shall not exceed 3 years. 3. The financial viability of all partners in projects shall fulfil the Commission applicable rules27. This will be checked at negotiation stage before the signature of the grant agreement. 4. Number of participants: minimum 3 established in at least three different EU Member States or Associated Countries with the specific condition for SMEs under point 6 below. The maximum number of participants is The estimated EU contribution going to SMEs shall be 50% or more of the total

17 estimated EU contribution for the project as a whole. The SME status and the financial viability will be assessed at the end of the negotiation, before signature of the grant agreement. 6. Participation of SMEs or SME joint ventures is restricted to entities established in EU Member States and Associated Countries. In addition, SMEs shall fulfil any of the following conditions: 1) be at least 51% owned and controlled by one or more individuals who are citizens of one of the EU Member States or Associated Countries or permanent residents in one of those countries, or 2) be at least 51% owned and controlled by another business that is itself at least 51% owned and controlled by individuals who are citizens of, or permanent residents in those countries. HEALTH : Safety and efficacy of therapeutic vaccines. FP7-HEALTH INNOVATION-1. The aim is to advance promising new therapeutic vaccines into clinical safety and efficacy testing. Chronic infectious diseases (including infections in immunocompromised patients), inflammatory and autoimmune diseases, allergies, degenerative, and metabolic diseases as well as vaccines against drug addictions, may be addressed. Excluded are cancer vaccines addressed in area The suggested therapy should be based on an active vaccination effect triggering a human immune response hence bearing particular innovation potential. Projects should focus on therapeutic vaccines for which efficacy has been demonstrated in preclinical work, e.g. in appropriate animal models. Projects will demonstrate that a therapeutic vaccine in the envisaged area is superior to existing or competing therapies under development, and that the expected cost-medical benefits ratio meets public health needs. Consortia should be strongly product-focused and should comprise only an essential number of contributing partners. Consortia will include industry, especially from the SME sector from EU Member States and/or Associated Countries. Note: Limits on the EU financial contribution will apply and will be implemented strictly as eligibility criterion. Funding scheme: Collaborative Project (small or medium-scale focused research project). One or more proposals may be selected. Expected impact: Promising therapeutic vaccine candidates should be further advanced in the development phase with a clear proof of concept for safety and efficiency, thus widely and profoundly boosting the field of vaccine R&D in Europe. Additional eligibility criteria: 1. The requested EU contribution per project shall not exceed EUR The estimated EU contribution going to industry including SMEs shall be 30 % or more of the total estimated EU contribution for the project as a whole. The SME status and the financial viability will be assessed at the end of the negotiation, before signature of the grant agreement. HEALTH : Comparative effectiveness research of existing technologies for prevention, diagnosis and treatment of cardiovascular diseases. FP7-HEALTH INNOVATION-1. Cardiovascular technologies used in clinical practice including those used for imaging and therapeutic procedures may vary widely in different countries and even amongst centres. In addition, systematic evidence regarding how approaches to prediction, diagnosis, treatment, monitoring and prognosis compare with one another is lacking. The project will compare the use of currently available technical procedures and/or devices in

18 selected broad populations. A comprehensive array of clinical and safety parameters, as well as socio-economic outcomes (e.g. quality of life, patient mortality, morbidity, costs, and performance of the health system) for chosen populations will be assessed. Randomised controlled trials, observational studies and meta-analyses may be considered for this topic. The study population should well address gender balance. Data sources to be used and methods to assess comparative effectiveness and cost effectiveness will be clearly defined. The project may include prospective data collection, development of clinical data networks, databases or patient registries. Dissemination activities aimed at raising awareness on the outcome of the study to the health care workforce may also be included, where appropriate. Note: Limits on the EU financial contribution will apply and will be implemented strictly as eligibility criterion. Funding scheme: Collaborative Project (small or medium-scale focused research project). One or more proposals may be selected. Expected impact: The purpose of this research is to inform patients, health care providers, and decision-makers, about which technologies are most effective in dealing with CVD. Additional eligibility criterion: The requested EU contribution per project shall not exceed EUR HEALTH : Comparative effectiveness research (CER) in health systems and health services interventions. FP7-HEALTH-2013-INNOVATION-1. Projects will evaluate the impact of two or more alternative health system and health services interventions in terms of their health benefit, patient needs, patient safety, effectiveness and quality of care. Research should also address the structural and policy components as well as cost effectiveness. It should use a multidisciplinary approach and take into account some of the different organisation of care models within Europe. A broad array of interventions and approaches may be studied under this topic, ranging from comparing effects of different models of integrated care on patient experiences, outcomes, and efficiency or comparing integrated care with more traditional models of care; analysing the uptake of new approaches such as stratified, individualised or personalised medicine; comparing the effectiveness of different quality improvement strategies in disease prevention; to assessing interventions such as promoting prudent use of antibiotics or smoking cessation. Different population groups will have to be taken into account where relevant. Note: Limits on the EU financial contribution will apply and will be implemented strictly as eligibility criterion. Funding scheme: Collaborative Project (small or medium-scale focused research project). One or more proposals may be selected. Expected impact: Results should assist policy makers and decision makers to make informed decisions regarding the implementation or improvement of health system and health services interventions in view of improving patient outcomes, quality of life and increase the costeffectiveness of interventions, ultimately improving health status at individual and population levels. Additional eligibility criterion: The requested EU contribution per project shall not exceed EUR

19 Not included but maybe relevant HEALTH : Optimising lifestyle interactions in the prevention and treatment of cardiovascular disease across the lifespan. FP7-HEALTH-2013-INNOVATION-1. Projects should examine the effects of primary and secondary prevention of cardiovascular diseases using lifestyle intervention strategies. Research may include understanding and optimising the dose-response relationship between physical activity and cardiovascular health, as well as the interaction(s) between physical activity, other lifestyle factors and pharmacotherapy. Projects should also combine in vivo and in vitro studies to advance our current understanding of the fundamental cellular and molecular mechanisms underpinning physical activity-dependent changes in cardiovascular health. Note: Limits on the EU financial contribution will apply and will be implemented strictly as eligibility criterion. Funding scheme: Collaborative Project (small-scale focused research project). One or more proposals may be selected. Expected impact: The purpose of this research is to provide solid evidence-based research to guide the prevention/treatment of cardiovascular diseases at primary/secondary levels. It might also lead to improved cohort stratification in existing clinical trial models. Successful application of lifestyle intervention strategies can be expected to yield substantial savings within existing unsustainable health care costs in the medium-to-long-term. Additional eligibility criterion: The requested EU contribution per project shall not exceed EUR HEALTH : New methodologies for clinical trials for small population groups. FP7-HEALTH-2013-INNOVATION-1. The objective is to develop new or improved statistical design methodologies for clinical trials aiming at the efficient assessment of the safety and/or efficacy of a treatment for small population groups in particular for rare diseases or personalised (stratified or individualised) medicine. Research should be multidisciplinary and should involve all relevant stakeholders including industry and patient advocacy groups as appropriate. Ideally, results would lead to improvement of clinical trial guidelines. Clinical trials as such are excluded from this topic. Collaboration with relevant organisations outside Europe is welcomed. Note: Limits on the EU financial contribution will apply and will be implemented strictly as eligibility criterion. Funding scheme: Collaborative Project (small-scale focused research project). One or more proposals may be selected. Expected Impact: Cost efficient clinical trials deriving reliable results from trials in small population groups. Additional eligibility criterion: The requested EU contribution per project shall not exceed EUR

20 SOCIO ECONOMIC SCIENCES AND HUMANITIES Topic for a small or medium-scale focused research project: SSH The impact of ageing societies on public finances in Europe Context Life expectancy in the EU continues to increase rapidly while fertility rates still remain low. This brings about a very considerable change in the age structure of the European population with a share of persons over 65 in the society rising rapidly. As a result of this trend the median age of the EU population, which is currently estimated at around 41 years, is projected to reach 48 years by the year The changing age structure is also bringing significant changes in the activity structure of society, with a decreasing share of the working age population expected to double the old-age dependency ratio by At the same time, especially in the wake of the financial and economic crisis, public finances are under tremendous pressure, with the EU public debt reaching over 80% of GDP, while pension systems in many countries are already, or will soon be, in structural deficit. It is therefore vital to understand how the gradual progress of population ageing will impact on public finances and their sustainability in the long term. Demography has an influence on government finance both through expenditure and revenue channels. On the one hand, public expenditures are affected, among others, by the activity structure of the population, health care and long-term care costs, as well as the scale of public services. By 2060, age-related expenditure is expected to increase by almost 5 percentage points of GDP overall. On the other hand, the share of population in employment and pension system reforms combined with changing patterns of consumption and investment, all have an impact on the structure of budget revenues. We need to gain a clearer understanding of all these linkages and interdependencies. Research dimensions Research should include the following aspects: A comprehensive analysis of national public finance systems in the European Union from the perspective of revenues and expenditures structure, as well as an assessment of how the ongoing ageing of the population has changed this structure so far and how it has affected the sustainability of public finances. Analysis of the intergenerational dimension of tax systems including how the changing age structure of the society impacts on the distribution of income and wealth across generations, for both women and men, and how it affects public finances and social cohesion. Assessment of the long-term impact (over years) of population ageing on the structure of budget revenues and expenditures as well as on the sustainability of public finances. This should take into account different scenarios of labour market participation among older age groups. Analysis of the necessary reforms of the tax system (both the revenue and expenditure sides), public services and the social security system in order to enhance the long-term sustainability of public finances and, at the same time, ensure social cohesion and intergenerational fairness, as well as an assessment of the broader social and economic implications of these reforms.

21 2012 Health HEALTH : Coordination action in support to the Joint Programming Initiative on "The microbial challenge an emerging threat to human health". FP7- JPROG-2012-RTD45. Following the Communication "Towards Joint Programming in Research: working together to tackle common challenges more effectively"46, the Commission has been encouraging Member States to pursue common visions and strategic research agendas in the domains identified by the High Level Group for Joint Programming (GPC) as suitable for Joint Programming Initiatives (JPIs). In its conclusions of 26 May 2010, the Competitiveness Council welcomed the identification and substantiation of six "second wave" themes for JPIs. Further, the Competitiveness Council invited the Commission to sustain the implementation of the proposed JPIs and "Act as a facilitator by suggesting complementary measures to support the Joint Programming initiatives"47. Therefore, the Commission decided to facilitate, by funding dedicated coordination actions, the JPIs which have reached a satisfactory level of maturity testified by: a) Adoption of a challenge-oriented problem-solving approach, backed by a solid and firm commitment by participating Member States or Associated Countries, which should include also provision of adequate human and financial resources. b) Development of a Strategic Research Agenda that, on the basis of an up-to-date mapping of research activities in the concerned areas, should have identified at least a limited number of measurable scientific-technological or socio-economic objectives, translating the challenge into operational terms, supported by an appropriate analysis of their relevance in relation to the addressed challenge and innovation potential. c) The presence of a governance system commensurate to the tasks, involving the participating organisations at an appropriate level. d) The European added value of the proposal be justified in terms of its scale, scope, increased effectiveness and/or cost savings potentially achieved. Scope of the Action: The Commission foresees to sustain the overall coordination and capacity-building process for the JPI "The microbial challenge an emerging threat to human health48", with the initial aim of shortening the time required to reach the implementation phase and then allow the adoption of effective and efficient methods of collaboration, such as those proposed within the "Voluntary Guidelines on Framework Conditions for Joint Programming in Research", adopted by the GPC on 11 November Funding scheme: Coordination and Support Action (coordinating action) Only up to one proposal can be selected. Expected impact: This action should help establish effective JPI governance structures. It should help develop a sharply focused and realistic strategic research agenda, based on the mapping and analysis of the state of the art in the specific field both at European and international level. Furthermore it should raise the scale and ambition of the research carried out in the specified domain beyond the level that would be otherwise sustainable, globally increasing the coherence and efficiency in the use of European resources. Additional eligibility criteria for this action: This topic is included in the cross-thematic call FP7-JPROG-2012-RTD. Complete information on the applicable additional eligibility criteria can be found in the corresponding call fiche. Please refer to the updated annex 4 to the 2012 Cooperation work programme.

22 HEALTH : Investigator-driven clinical trials43 for optimisation of management of elderly patients with multiple diseases. FP7-HEALTH INNOVATION-1. This topic as a whole contributes to the EIP Active and Healthy Ageing. The aim of the projects should be the comparison of outcomes of various treatment regimens for those diseases that are most common in elderly populations. Research will focus on drug therapy and other interventions for patients affected by and treated for multiple diseases. Studies should include the evaluation of efficacy and adverse events. Applicants must demonstrate that clinical trials are appropriately powered to produce statistically significant evidence. Gender aspects and differences related to age groups, ethnicity and socio-economic status should be appropriately considered. The clinical trials to be supported must be registered in a publicly accessible clinical trials registry. The applications must consider the relevant governance issues for clinical trials such as good clinical practice and respect of the appropriate international, European and national legislation and guidelines. Patient advocacy groups, which can contribute to the quality, feasibility and impact of clinical trials, should be involved where appropriate. Note: Limits on the EU financial contribution apply. These are implemented strictly as formal eligibility criteria. 43 Please consult also the text for clinical trials provided in the introduction to activity 2. Translating research for human health in this work programme on pages 9/10 FP7 Cooperation Work Programme: Health-2012 Page 27 of 76 Funding scheme: SME-targeted Collaborative project (small or medium-scale focused research project) One or more proposals can be selected. Expected impact: Three main impacts are expected: treatments better suited to the needs of older people, lowering healthcare costs and engaging in the pre-normative setting of geriatric medicines. Specific feature: SME-targeted research is designed to encourage SME efforts towards research and innovation. Priority will be given to proposals demonstrating that research intensive SMEs play a leading role. The projects will be led by SMEs with R&D capacities but the coordinator does not need to be an SME. The expected project results should clearly be of interest and potential benefit to SME(s). Additional eligibility criteria: The requested EU contribution per project shall not exceed EUR Projects will only be selected for funding on the condition that the estimated EU contribution going to SME(s) is at least 15% of the total estimated EU contribution for the project as a whole. This will be assessed at the end of the negotiation, before signature of the grant agreement. Proposals not fulfilling this criterion will not be funded. HEALTH : Improving the organisation of health service delivery62. FP7- HEALTH-2012-INNOVATION-1. The objective of this topic is to benchmark best practices regarding the structure, care processes, cost containment issues, reimbursement systems and performance of health care organisations in Europe. Applicants would be expected to address the issues of the organisational, management, financial (including costs) and regulatory aspects of health systems, including where appropriate the context of cross-border settings. The expected outputs would be an enhanced performance of Member States' health services based on proposals that address one ore more elements given below: The integration of care across organisations and how collaboration between different health care providers can integrate primary and secondary care in pathways. Such research for example could focus on the effect of integration on patient experiences, outcomes, and

23 efficiency; could examine the best forms of integration and under what conditions/context and for which patients groups is the integration of care suitable; and investigate the evaluation of new organisational approaches to integration. Quality of cost information for patient care. Research for example could focus on the assessment of health costing systems and practices for patient services (including the identification of best practice costing models); the analysis of the cost information quality, the impact and relevance upon decision making; the improvement of comparability of health cost data among EU countries with a view to advancing the economic efficiency of services. Patient-centred care and patient involvement and how organisations and patients, including self-help groups, can be empowered in this direction. Such research for example could focus on the evaluation of strategies, interventions, and incentives; under which conditions would new health technologies lead to more patient-centred care; investigate interventions and guideline adherence. Different health care settings should be taken into account. Skill mix and management of human resources. Such research for example could focus on the impact of changing skill mix of health professionals across Europe on quality of care and future health needs; the organisation of care processes and professional roles and competencies; the identification and comparison of successful health workforce planning strategies addressing the ageing health workforce and increasing mobility of health professionals across Europe63. The transfer of knowledge into practice using results and outcomes of relevant EU FP projects with regards to health systems and health services research64. Best practices and the factors that determine the transferability of these mechanisms65 should be considered, 62 The topic is open for proposals in all relevant research areas covered by the topic description; however some proposals, depending on their scientific content, may contribute to the EIP "Active and Healthy Ageing". 63 Proposals should taken into account work carried out by FP7 projects HealthPrometheus, MohProf & RN4CAST ( 64 See relevant FP7 projects (reference booklet public health research web pages) 65 See relevant FP7 projects such as BRIDGE, FIRE & SURE (reference public health project booklet) applying relevant tools and brokerage skills, to ensure that research findings and results are indeed applicable and used for a better organisation of health service delivery in Europe. Proposals that include participation from Member States engaged in reforming their health systems and candidate countries will be considered. Projects should generally be of 4 years' duration; however a proposal addressing the issue of knowledge into practice should span 5 years. Note: Limits on the EU financial contribution apply. These are implemented strictly as formal eligibility criteria. Funding scheme: Collaborative Project (small-scale focused research project) One or more proposals can be selected. Expected impact: This research should contribute to the scientific evidence base that supports Member States to better organise their health systems within the relevant policy context. Projects should address the varieties in health care practice across Europe's health care landscape including critically an understanding of the relationship between organisations and how patients move through them. Projects should advance the state of the art in the field of health services research, stimulate social innovation and enhance cooperation between researchers in Europe and other regions to promote integration and excellence of European research and social innovation in this field. Additional eligibility criterion: The requested EU contribution per project shall not exceed EUR

24 HEALTH : New methodologies for health technology assessment66. FP7- HEALTH-2012-INNOVATION-1. Health Technology Assessment (HTA) is intended to provide a bridge between the world of research and the world of decision-making by providing relevant information about the medical, social, economic, legal and ethical issues related to the use of health technology. This should be achieved in a systematic, transparent, unbiased and robust manner, also highlighted by the European network for Health Technology Assessment67. Research under this call should develop new and /or improved methodologies for HTA that address the present challenges affecting the current methodological framework regarding complexity, efficacy and effectiveness. Proposals should address one or more elements of the following areas: HTA methodologies should be broadened to expand further the spectrum and complexity of technologies assessed. For example complex interventions consisting of a wide spectrum of technologies and multidisciplinary delivery modes should be addressed, such as personalised medicines, public health interventions, organisational interventions and information and communication technologies related to health. Other challenges to be addressed could include the need for the continuous assessment of health technologies throughout their life cycles, the integration of social, organisational, ethical and legal aspects, assessment of relative effectiveness and to evaluate their implementation into health service provision. 66 The topic is open for proposals in all relevant research areas covered by the topic description; however some proposals, depending on their scientific content, may contribute to the EIP "Active and Healthy Ageing". 67 EUnetHTA JA is a joint action funded under the EC's 2nd Community Programme of public health in response to the 2009 call - Research for example could address the real need to complement those efforts already undertaken by the Member States' network of HTA organisations (EUnetHTA JA) as regards the development of HTA methodologies to assess, for example, the efficacy and effectiveness of technologies. The applicability of these technologies into broader clinical contexts requires a better understanding of their use. In addition, there is a need to strengthen HTAs so that they may be used in very specific and particular circumstances, such as in hospital settings - mini-htas, where very local contextual organisational considerations have to be taken into account. Non-exhaustive examples would include: advanced therapies68, diagnostics, medical devices, personalised medicines, transfusion and transplantation, health-related information and communication technologies. Collaboration between the selected projects should be foreseen in the proposals in view of exchanging information and promoting the development of best practice. Note: Limits on the EU financial contribution apply. These are implemented strictly as formal eligibility criteria. Funding scheme: Collaborative Project (small-scale focused research project) One or more proposals can be selected. Expected impact: This research should improve the scope, validity and applicability of HTA as a tool to determine the potential impact of innovative technologies on individual and population health gains. It should complement work undertaken by the European Network for Health Technology Assessment and broaden the HTA methodological framework to develop it into a truly meaningful tool that provides structured, evidence-based input into health policies that are patient-focused and promoting good quality care, equity in access and best value for money69. Additional eligibility criterion: The requested EU contribution per project shall not exceed EUR