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Work Programme 2011 COOPERATION THEME 1 Health (European Commission C(2010) 4900 of 19 July 2010) FP7 Cooperation Work Programme: Health-2011 Page 2 of 74 FP7 Cooperation Work Programme: Health-2011 I CONTEXT ................................................................................................................................................... 4 II CONTENT OF CALLS............................................................................................................................. 10 1. BIOTECHNOLOGY, GENERIC TOOLS AND MEDICAL TECHNOLOGIES FOR HUMAN HEALTH .............................. 10 1.1 High-throughput research ..................................................................................................................... 10 1.2 Detection, diagnosis and monitoring..................................................................................................... 12 1.3 Suitability, safety, efficacy of therapies ................................................................................................. 12 1.4 Innovative therapeutic approaches and interventions........................................................................... 12 2. TRANSLATING RESEARCH FOR HUMAN HEALTH ............................................................................................. 17 2.1 Integrating biological data and processes: large-scale data gathering, systems biology..................... 18 2.1.1 Large-scale data gathering............................................................................................................................... 18 2.1.2 SYSTEMS BIOLOGY .................................................................................................................................... 22 2.2 Research on the brain and related diseases, human development and ageing...................................... 22 2.2.1 Brain and brain-related diseases ...................................................................................................................... 22 2.2.2 Human development and ageing...................................................................................................................... 25 2.3 Translational research in major infectious diseases: to confront major threats to public health ......... 27 2.3.1 Anti-microbial drug resistance......................................................................................................................... 27 2.3.2 HIV/AIDS, malaria and tuberculosis............................................................................................................... 30 2.3.3 Potentially new and re-emerging epidemics .................................................................................................... 30 2.3.4 Neglected infectious diseases .......................................................................................................................... 32 2.4 Translational research in other major diseases .................................................................................... 32 2.4.1 Cancer.............................................................................................................................................................. 32 2.4.2 Cardiovascular diseases................................................................................................................................... 34 2.4.3 Diabetes and obesity........................................................................................................................................ 36 2.4.4 Rare diseases ................................................................................................................................................... 39 2.4.5 Other chronic diseases ..................................................................................................................................... 39 3. OPTIMISING THE DELIVERY OF HEALTHCARE TO EUROPEAN CITIZENS ........................................................... 40 3.1 Translating the results of clinical research outcome into clinical practice including better use of medecines, and appropriate use of behavioural and organisational interventions and new health therapies and technologies.......................................................................................................................................... 40 3.2 Quality, efficiency and solidarity of healthcare systems including transitional health systems ............ 40 3.3 Health promotion................................................................................................................................... 40 3.4 International public health & health systems ........................................................................................ 43 4. OTHER ACTIONS ACROSS THE HEALTH THEME ............................................................................................... 45 4.1 Coordination and support actions across the theme ............................................................................. 45 4.2 Responding to EU policy needs ............................................................................................................. 47 III IMPLEMENTATION............................................................................................................................... 51 Call title: HEALTH 2011: single-stage ....................................................................................................... 51 Call title: HEALTH 2011: two-stage........................................................................................................... 60 IV OTHER ACTIONS ................................................................................................................................... 71 V BUDGET .................................................................................................................................................... 73 Theme Health - Indicative budget................................................................................................................ 73 General activities - Indicative budget.......................................................................................................... 74 Page 3 of 74 FP7 Cooperation Work Programme: Health-2011 Objective: Improving the health of European citizens and increasing the competitiveness and boosting the innovative capacity of European health-related industries while businesses, and addressing global health issues including emerging epidemics. Emphasis will be put on translational research (translation of basic discoveries in clinical applications including scientific validation of experimental results) the development and validation of new therapies, methods for health promotion and prevention including promotion of child health healthy ageing, diagnostic tools and medical technologies, as well as sustainable and efficient healthcare systems. I CONTEXT Approach for 2011 The work programme 2011 is to be published in July 2010 for proposals to be selected in 2011. It aims to ensure complementarity with the previous work programme and to concentrate on specific activities within the budgetary constraints. The estimated total budget allocation for work programme 2011 is EUR 682 million (to be confirmed) drawing from the 2011 budget1. Section II of this document describes the topics for which project proposals can be submitted; sections III and IV describe the modalities for implementation of the different calls2 and other actions. The estimated budget breakdown for work programme 2011 is provided in section V. Priorities are based on the coverage of the Specific Programme, major policy initiatives, like “competitiveness for the future”3 including the European Research Area (ERA) as well as input from all relevant stakeholders, such as Programme Committee members, advisory group, learned societies, and the state of play regarding scientific opportunities and healthcare needs. STRATEGIC FRAMEWORK AND RESPONDING TO EU POLICY NEEDS The Health Theme is aligned with the fundamental objectives of EU policies: increasing innovation and competitiveness of European health-related industries and services and improving the health of European citizens. It also addresses global health issues and the socio-economic dimension in various areas of health research. Major efforts in 2011 concentrating on topics4 dedicated to small and medium enterprises (SMEs) will contribute to the new Commission's emphasis, as outlined in the Europe 2020 strategy for smart, sustainable and inclusive growth5, on "competitiveness for the future" including "boosting the new sources of growth…" which "requires a strengthening of Europe's industrial base" (Barroso, 20096). Whereas, two high impact research initiatives as pilot projects (with a maximum of EUR 30 million each) in the fields of epigenomics and 1 2 3 Under the condition that the draft budget for 2011 is adopted without modifications by the budgetary authority. FP7-HEALTH-2011-single-stage; FP7-HEALTH-2011-two-stage; FP7-ERANET-2011-RTD; Political Guidelines for the New Commission, J.M. Barroso, 2009. 4 HEALTH.2011.1.1-1; HEALTH.2011.1.1-2; HEALTH.2011.1.4-2; HEALTH.2011.1.4-3; HEALTH.2011.1.44; HEALTH.2011.2.1.1-1 HEALTH.2011.2.3.1-4; HEALTH.2011.2.3.1-5; HEALTH.2011.2.4.2-2; HEALTH.2011.4.2-3 5 6 http://ec.europa.eu/eu2020 (March 2010) Political Guidelines for the New Commission, J.M. Barroso, 2009. Page 4 of 74 FP7 Cooperation Work Programme: Health-2011 immunisation will both contribute to the “European innovation economy” (i-conomy)7 and to the completion of the European Research Area (ERA). Both, the SME orientation of the 2011 health research work programme and the large pilot projects present excellent potential for innovation. Furthermore, in order to boost innovative drugs and health solutions in Europe the Health Theme makes a major effort into investigator-driven clinical trials in various fields. With a focus on brain-related diseases, diabetes, and cancer (incorporating life style issues and social determinants of health) the 2011 work programme addresses major health-related societal challenges. Finally, with a focus on antimicrobial drug resistance and emerging epidemics, the Health Theme continues to address global health issues of utmost importance. Research actions will continue to support EU efforts to adapt off-patent medicines to the needs of paediatric populations and to investigate adverse drug reactions at the European level. Efforts will continue to ensure complementarity and coherence with the Innovative Medicines Initiative (IMI)8,9 priorities for 2010 and 2011 and with the European and Developing Countries Clinical Trials Programme (EDCTP)10 to combat poverty-related diseases. NEW KEY RESEARCH CHALLENGES The work programme health 2011 focuses on the following key research challenges: 1) Increasing innovation and competitiveness of European health-related industries and services by attracting higher SME participation In view of the Europe 2020 strategy for smart, sustainable and inclusive growth11 and the current economic and societal challenges it is of utmost importance to tackle key health research targets. A major effort on SME participation will stimulate innovation, increase the participation of SMEs in clinical trials, increase the drive to develop of new therapies, technologies and drugs to marketable products, and thus create a considerable European added value in the European health research area. Research-intensive SMEs must be attracted to participate in the Health Theme to ensure that new research and development (R&D) findings are brought to the market and to patients. To boost SME participation both quantitatively and qualitatively, a number of SME dedicated topics are included with opportunities for SMEs not only to participate, but to take leading roles in projects. To ensure a bottom-up and innovative approach, the topics are broadly defined and proposals will be evaluated using the two-stage submission and evaluation procedure. 2) Two pilot actions for high impact research initiatives (large-scale integrating research projects, up to EUR 30 million) Epigenomics. This pilot action will be launched to integrate several components, such as epigenomic mapping in health and diseases, high-throughput technology, diagnostic tools, 7 Innovation Summit of the Lisbon Council, 5 March 2010 8 COUNCIL REGULATION (EC) No 73/2008 of 20 December 2007 setting up the Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines 9 http://imi.europa.eu/index_en.html 10 European and Developing Countries Clinical Trials Partnerships 11 http://ec.europa.eu/eu2020 (March 2010) Page 5 of 74 FP7 Cooperation Work Programme: Health-2011 targeted intervention drug screening in the context of comparative clinical trials. This integrated research effort should contribute to understanding diseases and the impact of lifestyle on health. It will integrate research activities and structure the ERA in a global context on an unprecedented scale in this emerging field of research. Immunisation strategies and applications. The aim is to apply advanced technologies to the study of human immune responses under conditions of health and disease and to develop improved immunisation strategies depending on the pathological condition. Newly generated knowledge should lead to the development of rational strategies in immunisation. Different means of immunisation (systemic, local, mucosal) using different platforms and formulations will be investigated and will have significant effects on the effectiveness of new interventions. 3) Supporting innovative clinical trials12 to verify safety and efficacy The aim is to strengthen clinical research in Europe in a number of areas with unmet medical needs. Specific actions under clinical trials listed in this work programme (especially under investigator-driven clinical trials) will have a major European added value into translating research to clinical practice. The objective is increasing therapeutic options for patients, stimulating the implementation of best practice in all Member States (MS) and in establishing the basis for a coherent programme addressing the issue of personalized medicine and improved therapeutic outcomes. 4) How lifestyle affects health and how can this be mitigated Lifestyle factors (nutrition, environment, stress, smoking, alcohol and drug intake, exercise, etc.) have a considerable, but not always well understood, impact on a variety of health issues. A coordinated effort is needed to achieve a better understanding of the underlying causes, mechanisms and possible mitigating factors or interventions for better health. This effort will be supported throughout the work programme in particular in area 3.3 "health promotion" of the activity "Optimising the delivery of health care". Brain-related diseases, including lifestyle-related health issues. The focus is on lifestylerelated health problems such as addiction as well as other mental health issues not yet covered by the previous calls such as compulsive disorders in children. In the area of neurodegenerative diseases, in particular Alzheimer's disease, a set of topics is foreseen to complement the objectives and actions of the Joint Programming initiative thereby contributing to ERA objectives. Lifestyle determinants: diabetes, obesity and cardiovascular diseases. The emphasis is on clinical trials, prevention, epidemiology and controlled intervention. Actions include research on lifestyle and/or therapeutic approaches for diabetes; controlled intervention trials on lifestyle changes and concomitant therapeutic intervention on high-risk populations and on epidemiological studies on obesity. Coordination with Theme 2 'Food, Agriculture and fisheries, and Biotechnology' ('KBBE') is foreseen on diet/nutrition and disease development. There could be a strong component of international cooperation, through global approaches, on diabetes / obesity and on early life programming. Social determinants of health. The size scale, persistence and increase in the differences in health of people living in different parts of the EU and between socially advantaged and disadvantaged EU citizens represents a challenge to the EU's commitment to solidarity and 12 http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/vol-10/ 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 17/18 Page 6 of 74 FP7 Cooperation Work Programme: Health-2011 equality of opportunity. Tackling health inequalities requires a coordinated response across relevant policy areas, as reflected in the Commission Communication on Solidarity in Health13, and more inter-sectoral and interdisciplinary research to support actions addressing health inequalities taking into account differences in lifestyle. This approach also applies to low and middle income countries where the societal and economic challenges and the related burden of disease are even greater. 5) Global health issues The work programme also covers the complementary policy objective of addressing specific global health issues. Greater focus will be placed on antimicrobial resistance and continuing to address emerging epidemics. In antimicrobial resistance the aim will be to further focus on understanding of the evolution and the transfer of antibiotic resistance as well as antimicrobial drug resistance in Gram negative infections, the development of tools to control microbial biofilms and the development of multi-analyte diagnostics. Concerning emerging epidemics, transmission and immunology issues, as well as behavioural aspects relevant to preparation for and action during pandemics are also addressed in topics of this work programme. • International Cooperation International cooperation continues to be an integral part of the Health Theme with many opportunities throughout the work programme to include international cooperation partner countries. In particular, in the area of diabetes / obesity and on early life programming, the need for a global approach encompassing several regions of the world such as the Mediterranean region, Sub-Saharan Africa, Latin America, Asia, etc. is envisioned. In recognition of the opening of NIH14 programmes to European researchers, participants established in the United States of America are eligible for funding and participation in all topics described in this work programme. Specific international cooperation actions (SICA15) will target research activities in the areas of human genetics (Eastern Europe and Central Asia (EECA) countries), infectious diseases (Latin America and Asia), diabetes/obesity (integrated initiative with multiple international partners) and addressing health inequalities in the context of reproductive health and capacity building (ICPC)16, supporting the realisation of the Millennium Development Goals (MDG). Furthermore, programme level cooperation where the cooperating countries finance their own complementary projects, will be pursued with individual countries (such as Australia, Brazil, India, Mexico and Russia). The 2010 EU-Latin America and Caribbean (LAC) Summit17 focused on bi-regional cooperation on "Innovation and technology for sustainable development and social inclusion". The Summit's Action Plan calls for boosting science and technology cooperation between the EU and LAC countries. The activities targeting LAC contribute to sustainability as advocated 13 14 Solidarity in Health - Reducing Health Inequalities in the EU" (20th October 2009) National Institutes of Health of the US Department of Health and Human Services 15 The list of international cooperation partner countries (ICPC) is provided in Annex I to the Cooperation Programme ftp://ftp.cordis.europa.eu/pub/fp7/docs/icpc-list.pdf 16 The list of international cooperation partner countries (ICPC) is provided in Annex I to the Cooperation Programme ftp://ftp.cordis.europa.eu/pub/fp7/docs/icpc-list.pdf 17 Madrid, 18-19 May 2010. See also ec.europa.eu/research/inco – Latin America and Caribbean Page 7 of 74 FP7 Cooperation Work Programme: Health-2011 by the Summit. This requires an integrated approach taking into account the environmental, economic and social dimensions and a balanced involvement of research teams and the relevant stakeholders from Europe and the LAC region in the consortia. Special attention will be paid to the uptake and use of the new knowledge generated and, whenever relevant, to SME participation. Where appropriate, synergies and/or complementarities among projects selected from the LAC focused topics18 are encouraged within the same theme or across themes. In these cases, a dedicated budget for coordination or joint outreach activities could be foreseen. For information on LAC related topics in other themes, see the corresponding work programme chapters19. • Cross-thematic approaches Coordination with 'Cooperation' programme Theme 2 'Food, Agriculture and Fisheries, and Biotechnology' ('KBBE') is foreseen on diet/nutrition and disease development. Coordination with the 'Capacity' programme Area 5 'Science and Society' ('SIS') is foreseen on topic SiS2011-1.0-1 Mobilisation and Mutual Learning (MML) Action Plans on societal challenges. • Dissemination actions The health market is highly fragmented in Europe, with different public health policies in Member States. To sustain the competitiveness of the health sector, it is necessary to improve the framework conditions for business to innovate20: creating the single EU Patent and a specialised Patent Court, harmonising the regulatory framework, improving access of SMEs to Intellectual Property Protection. In 2011 complementary actions are foreseen with an emphasis on valorisation of research results, as well as the networking of major research institutions participating in the Health Theme to coordinate dissemination actions. Furthermore, for health promotion and disease prevention, brokerage actions are foreseen to ensure a direct translation of research findings in this area to the relevant users. Furthermore a new set of actions for dissemination are proposed21. Open Access Pilot in FP7: Beneficiaries funded partially or entirely by the Cooperation Programme under the Health Theme are required to deposit peer-reviewed articles resulting from projects to an institutional or subject-based repository, and to make their best efforts to ensure open access to these articles within six months.22 18 HEALTH.2011.1.4-5; HEALTH.2011.2.3.3-2; HEALTH.2011.2.4.3-4; HEALTH.2011.3.4-3; HEALTH.2011.4.1-3 19 'Health', 'Food, Agriculture, Fisheries and Biotechnology' (FAFB), 'Information and Communication Technologies', 'Nanosciences, Nanotechnologies, Materials and New Production Technologies' (NMP), 'Environment (including climate change)', 'Transport (including aeronautics)' and 'Social Sciences and Humanities'. 20 Europe 2020 Innovation Partnerships 21 HEALTH.2011.2.3.3-3 22 Further information: http://cordis.europa.eu/fp7/find-doc_en.html, http://ec.europa.eu/research/sciencesociety/open_access, http://ec.europa.eu/research/science-society/scientific_information/. Page 8 of 74 FP7 Cooperation Work Programme: Health-2011 • Socio-economic dimension of research Where relevant, account should be taken of possible socio-economic impacts of research, including its intended and unintended consequences and the inherent risks and opportunities. A sound understanding of this issue should be demonstrated both at the level of research design and research management. In this context, where appropriate, the projects should ensure engagement of relevant stakeholders (e.g., user groups, civil society organisations, policy-makers) as well as cultivate a multi-disciplinary approach (including, where relevant researchers from social sciences and humanities). Projects raising ethical or security concerns are also encouraged to pay attention to wider public outreach. • Gender dimension The pursuit of scientific knowledge and its technical application towards society requires the talent, perspectives and insight that can only be assured by increasing diversity in the research workforce. Therefore, all projects are encouraged to have a balanced participation of women and men in their research activities and to raise awareness on combating gender prejudices and stereotypes. When human beings are involved as users, gender differences may exist. These will be addressed as an integral part of the research to ensure the highest level of scientific quality. In addition, specific actions to promote gender equality in research can be financed as part of the proposal, as specified in Appendix 7 of the Negotiation Guidance Notes23. • Theme specific information With regard to submission, evaluation and selection procedures, both single-stage as well as two-stage submission and evaluation procedures will be used in separate calls. The relevant call is indicated for each topic in section II and the details for the procedures in separate call fiches in section III. It is particularly important that applicants address the potential ethical issues of their proposals, both in the proposed methodology and the possible implications of the results. The specific requirements for addressing ethical issues24 are described in the Guide for Applicants (Annex 4, section 4). The differences of gender/sex in research (risk factors, biological mechanisms, causes, clinical features, consequences and treatment of diseases and disorders) must be considered where appropriate. Use of animals in research: Research activities should take into account the Protocol on the Protection and Welfare of Animals, and reduce - with a view to ultimately replacing - the use of animals in research and testing (Decision 1982/2006/EC). The principle of the three Rs (Reduction, Refinement and Replacement) should be applied where appropriate in all research funded by the European Commission. Funding schemes: The work programme 2011 is implemented through a range of funding schemes. The types of the grants to be used for the various funding schemes are described in section III and the guides for applicants. For each funding scheme there are upper limits on the requested EU contribution (see topic description in section II and table 2 in section III for details). It is important to note that funding limits will be applied as eligibility criteria. Proposals that do not respect this limit will be considered ineligible (see section III implementation). Furthermore, proposals responding to a Specific International Cooperation 23 24 ftp://ftp.cordis.europa.eu/pub/fp7/docs/negotiation_en.pdf http://cordis.europa.eu/fp7/ethics_en.html Page 9 of 74 FP7 Cooperation Work Programme: Health-2011 Actions (SICA25) topic must involve at least two participants from different Member States or Associated States plus two from different International Cooperation Partner Countries (ICPC)26, (see details in topic descriptions in section II). After fulfilling this condition, however, any other countries may participate. II CONTENT OF CALLS 1. BIOTECHNOLOGY, GENERIC TOOLS AND MEDICAL TECHNOLOGIES FOR HUMAN HEALTH This activity aims at developing and validating the necessary tools and technologies that will enable the production of new knowledge and its translation into practical applications in the area of health and medicine. 1.1 HIGH-THROUGHPUT RESEARCH The objective is to catalyse progress in developing new research tools for modern biology including fundamental genomics that will significantly enhance data generation and improve data and specimen (bio-banks) standardisation, acquisition and analysis. The focus is on new technologies for: sequencing; gene expression, genotyping and phenotyping; structural and functional genomics; bioinformatics and systems biology; other 'omics'. Note: Depending on the topics listed below, applicants will have to follow the rules for single or two-stage submission procedure (see also respective call fiche in section III). HEALTH.2011.1.1-1: SME-targeted research for developing tools and technologies for high-throughput research. FP7-HEALTH-2011-two-stage. Research should focus on the development and improvement of high throughput research tools and technologies. The proposed activities should also take into account quality control aspects as appropriate. Note: Limits on the EU financial contribution apply. These are implemented strictly as formal eligibility criteria. Funding scheme: SME-targeted Collaborative Project. Requested EU contribution per project: Maximum EUR 6 000 000. One or more proposals can be selected. 25 The list of international cooperation partner countries (ICPC) is provided in Annex I to the Cooperation Programme ftp://ftp.cordis.europa.eu/pub/fp7/docs/icpc-list.pdf 26 With the exception of Brazil, China, India and Russia, for which the required two or more ICPC participants can be located in the same country but at least two different participants must come from two different provinces, republics, states oblasts within Brazil, China, India or Russia. The list of international cooperation partner countries (ICPC) is provided in Annex I to the Cooperation Programme ftp://ftp.cordis.europa.eu/pub/fp7/docs/icpc-list.pdf Page 10 of 74