Tackling high-burden for patients, under-researched medical conditions
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2024-DISEASE-03-14-two-stage
- Programme
- Tackling diseases (Two stage - 2024)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- April 26, 2023
- Deadline
- September 19, 2023
- Deadline Model
- two-stage
- Budget
- €25,000,000
- Min Grant Amount
- €6,000,000
- Max Grant Amount
- €7,000,000
- Expected Number of Grants
- 4
- Keywords
- HORIZON-HLTH-2024-DISEASE-03-14-two-stageHORIZON-HLTH-2024-DISEASE-03-two-stageChronic diseasesClinical researchHealth policiesHealth policy and servicesHealth services, health care research
Description
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to most of the following expected outcomes:
- The scientific and clinical communities make effective use of state-of-the-art information, data, technologies, tools and best practices to better understand the condition, underpinning the development of diagnostics, therapeutics and/or preventive strategies.
- The scientific and clinical community exchange data, knowledge and best practices, thereby strengthening their collaboration and building knowledge and care networks in Europe and beyond.
- The scientific and clinical community make wide use of newly established and where relevant open access databases and/or integrate them with existing infrastructures for storage and sharing of collected data according to FAIR[1] principles, thereby encouraging further use of the data.
- Policymakers and funders are informed of the research advances made and consider further support in light of the sustainability of the studies.
- Patients and caregivers are constructively engaged with the research, which also caters for their needs.
- Health professionals have access to and use improved clinical guidelines on diagnosis and/or treatment of the condition.
A number of medical conditions fail to be recognised and/or be correctly diagnosed in a significant proportion of patients. As a consequence they are inadequately treated and often can become a chronic and high burden for the patient. These medical conditions[2] may be insufficiently researched even though they manifest with high prevalence[3], [4].
This topic excludes rare diseases.
Proposals should address all of the following aspects:
- Proposals should address the gaps in robust, scientific evidence for improved policies and practices to tackle such medical condition(s), and aim at identifying the pathophysiological mechanism(s) (e.g. genetic, cellular and molecular) and potential risk factors (e.g. psychological and environmental) of the medical condition(s) through basic, pre-clinical and/or clinical research. These efforts should underpin the development of diagnostics, therapeutics, and/or preventive strategies for the condition.
- Proposals should demonstrate that the medical condition(s) under study is/are insufficiently understood, inaccurately diagnosed or inadequately treated in a significant proportion of patients, and as such represent a high burden for patients and society. This could be through referencing key literature.
- Sex and gender aspects, age, ethnicity, socio-economic, lifestyle and behavioural factors should be taken into consideration. In addition, the emotional and societal long-term effects of these chronic disorders for the affected individuals should be addressed.
- Where applicable, the development of biomarkers and other technologies for diagnosis, monitoring in patients, and stratification of patient groups should be considered.
- Where applicable, the development of clinically relevant, (non-)human model systems that can complement clinical investigations should be considered.
- Exploitation of existing data, biobanks, registries and cohorts is expected, together with the generation of new (e.g. genomics, epigenomics, transcriptomics, proteomics) data.
- To enable sharing of samples, quality data and advanced analytical tools, it is encouraged to make use of existing infrastructures developed at the European[5] or national level.
- Inclusion of patients or patient organisations in the research is strongly encouraged, to ensure that their views are considered.
- SME participation is strongly encouraged.
This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.
Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.
[1] See definition of FAIR data in the introduction to this work programme part.
[2] High-burden medical conditions could for instance include those that are either life-threatening or lead to chronic invalidity or a severely reduced quality of life.
[3] Examples of medical conditions include chronic Lyme disease, Myalgic encephalomyelitis/ chronic fatigue syndrome and low back pain.
[4] The European Commission commissioned an independent scoping study to help identify high-burden under-researched medical conditions and define the type of research and/or research priorities to better address the different needs of patients with these conditions. The study delivered a discussion paper with a non-exhaustive list of conditions/groups of disorders identified as being high-burden and under-researched. This document is available at https://op.europa.eu/en/publication-detail/-/publication/eae32303-96e3-11ed-b508-01aa75ed71a1/language-en/format-PDF/source-278963958
[5] A variety of infrastructures have been developed at European level and include, for example, the BBMRI-ERIC research infrastructure for biobanking, while others are being developed like the ‘Federated European infrastructure for genomics data’.
Destination & Scope
Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-D ‘Creating a more resilient, inclusive and democratic European society’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘Good health and high-quality accessible healthcare’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘health care providers are able to better tackle and manage diseases (infectious diseases, including poverty-related and neglected diseases, non-communicable and rare diseases) and reduce the disease burden on patients effectively thanks to better understanding and treatment of diseases, more effective and innovative health technologies, better ability and preparedness to manage epidemic outbreaks and improved patient safety’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘A resilient EU prepared for emerging threats’, ‘Climate change mitigation and adaptation’, and ‘High quality digital services for all’.
Communicable and non-communicable diseases cause the greatest amounts of premature death and disability in the EU and worldwide. They pose a major health, societal and economic threat and burden. Many people are still suffering from these diseases and too often dying prematurely. Non-communicable diseases, including mental illnesses and neurodegenerative diseases, are responsible for up to 80% of EU health care costs[1]. These costs are spent on the treatment of such diseases that to a large extent are preventable. Furthermore, only around 3% of the health care budgets are currently spent on preventive measures although there is a huge potential for prevention. Infectious diseases, including emerging infectious diseases and infections resistant to antimicrobials, remain a major threat to public health in the EU but also to global health security. Deaths caused by antimicrobial resistance (AMR) could exceed 10 million per year worldwide according to some predictions[2].
To further advance, there is an urgent need for research and innovation to develop new preparedness and prevention measures, public health interventions, diagnostics, vaccines, therapies, alternatives to antimicrobials, as well as to improve existing preparedness and prevention strategies to create tangible impacts, taking into account sex/gender-related issues. This will require international cooperation to pool the best expertise and know-how available worldwide, to access world-class research infrastructures and to leverage critical scales of investments on priority needs through a better alignment with other funders of international cooperation in health research and innovation. The continuation of international partnerships and cooperation with international organisations is particularly needed to combat infectious diseases, to address antimicrobial resistances, to respond to major unmet medical needs for global health security, including the global burden of non-communicable diseases, and to strengthen patient safety.
In this work programme, destination 3 will focus on major societal challenges linked to the Commission’s political priorities such as the fight against cancer and other non-communicable diseases, better diagnosis and treatment of rare diseases, preparedness and response to and surveillance of health threats and epidemics, reduction of the number of antimicrobial-resistant infections, improving vaccination rates, demographic change, mental health and digital empowerment in health literacy. In particular, the topics under this destination will support activities aiming at: i) better understanding of diseases, their drivers and consequences, including pain and the causative links between health determinants and diseases, and better evidence-base for policymaking; ii) better methodologies and diagnostics that allow timely and accurate diagnosis, identification of personalised treatment options and assessment of health outcomes, including for patients with a rare disease; iii) development and validation of effective intervention for better surveillance, prevention, detection, treatment and crisis management of infectious disease threats; iv) innovative health technologies developed and tested in clinical practice, including personalised medicine approaches and use of digital tools to optimise clinical workflows; v) new and advanced therapies for non-communicable diseases, including rare diseases developed in particular for those without approved options, supported by strategies to make them affordable for the public payer; and vi) scientific evidence for improved/tailored policies and legal frameworks and to inform major policy initiatives at global level (e.g. WHO Framework Convention on Tobacco Control; UNEA Pollution Implementation Plan).
In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 3 “Civil security for society” such as on health security/emergencies (preparedness and response, medical countermeasures, epidemic outbreaks/pandemics, natural disasters and technological incidents, bioterrorism); with cluster 4 “Digital, Industry and Space” such as on decision-support systems or on geo-observation and monitoring (e.g. of disease vectors, epidemics); or with cluster 6 “Food, bioeconomy, natural resources, agriculture and environment” such as on health security and AMR (one-health: human/animal/plant/soil/water health). In addition, while focusing on civilian applications, there may be there may be synergies with actions conducted under the European Defence Fund, notably in the field of defence medical countermeasures.
Based on needs that emerged during the management of COVID-19, some research and innovation actions under Destination 3 should support the mission of the European Health Emergency and Response Authority (HERA) to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies by ensuring the availability and access to key medical countermeasures. Other actions should deliver relevant complementary inputs to the “Europe’s Beating Cancer Plan”[3] in order to cover the entire cancer care pathway, including prevention, early detection, diagnosis, treatment, cancer data monitoring, as well as quality of life of cancer patients and survivors. Furthermore, synergies and complementarities will be sought between Destination 3 and the implementation of the EU4Health Programme (2021-2027)[4]. These synergies and complementarities could be achieved, notably through mechanisms based on feedback loops, enabling on the one hand to identify policy needs that should be prioritised in research and innovation actions and facilitating on the other hand the implementation of research results into policy actions and clinical practice, thereby providing an integrated response across sectors and policy fields.
Expected impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to tackling diseases and reducing disease burden, and more specifically to several of the following impacts:
- Health burden of diseases in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, digital and other people-centred solutions for health care. In particular, patients are diagnosed early and accurately and receive effective, cost-efficient and affordable treatment, including patients with a rare disease, due to effective translation of research results into new diagnostic tools and therapies.
- Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and well-being is promoted, and the voluntary targets of the WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020 are attained (by 2025), with an immediate impact on the related disease burden (DALYs)[5],[6], [7].
- Health care systems benefit from strengthened research and innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation. In particular, they are better prepared to respond rapidly and effectively to health emergencies and are able to prevent and manage communicable diseases transmissions epidemics, including within healthcare settings.
- Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide[8], [9].
- Patients and citizens are knowledgeable of disease threats, involved and empowered to make and shape decisions for their health, and better adhere to knowledge-based disease management strategies and policies (especially for controlling outbreaks and emergencies).
The EU benefits from high visibility, leadership and standing in international fora on global health and global health security.
[1] Currently, around 50 million people in the EU are estimated to suffer from two or more chronic conditions, and most of these people are over 65. Every day, 22 500 people die in Europe from those diseases, counting of 87% of all deaths. They account for 550 000 premature deaths of people of working age with an estimated €115 billion economic loss per year (0.8% of GDP).
[2] AMR is estimated to be responsible for 25 000 deaths per year in the EU alone and 700 000 deaths per year globally. It has been estimated that AMR might cause more deaths than cancer by 2050.
[4] https://ec.europa.eu/health/funding/eu4health_en
[5] WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020 (resolution WHA66.10), https://www.who.int/publications/i/item/9789241506236
[6] Including for instance the following voluntary targets (against the 2010 baseline): A 25% relative reduction in the overall mortality from cardiovascular diseases, cancer, diabetes, or chronic respiratory diseases; Halt the rise in diabetes and obesity; An 80% availability of the affordable basic technologies and essential medicines, including generics, required to treat major non-communicable diseases in both public and private facilities.
[7] Disability-adjusted life year (DALY) is a quantitative indicator of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death.
[8] WHO global action plan on antimicrobial resistance, 2015
[9] EU One Health Action Plan against AMR, 2017
Eligibility & Conditions
General conditions
Applicants submitting a proposal under the blind evaluation pilot (see General Annex F) must not disclose their organisation names, acronyms, logos, nor names of personnel in Part B of their first stage application (see General Annex E).
2. Eligible countries: described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes.
This topic is part of the blind evaluation pilot under which first stage proposals will be evaluated blindly.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes.
Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025). [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes.
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme.
Documents
Call documents:
Standard application form (HE RIA IA Stage 1) - call-specific application form is available in the Submission System
Standard application form (HE RIA, IA) - call-specific application form is available in the Submission System
Standard evaluation form (HE RIA, IA and CSA Stage 1)
Standard evaluation form (HE RIA, IA)
Lump Sum MGA v1.0
Information on clinical studies (HE)
Guidance: "Lump sums - what do I need to know?"
Detailed budget table (HE LS)
Additional documents:
HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 13. General Annexes
HE Programme Guide
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement
Support & Resources
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Latest Updates
CALL UPDATE: FLASH EVALUATION RESULTS
EVALUATION results
Published: 07.12.2022
Deadline: 11.04.2024
Available budget: EUR 30,000,000
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation for the topic HORIZON-HLTH-2024-DISEASE-03-14-two-stage are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 15
Number of inadmissible proposals: 0
Number of ineligible proposals: 0
Number of above-threshold proposals: 7
Total budget requested for above-threshold proposals: EUR 50,960,670.85
Number of proposals retained for funding: 4
Number of proposals in the reserve list: 2
Funding threshold[1]: 14.5
Ranking
Number of proposals with scores lower or equal to 15 and higher or equal to 14: 4
Number of proposals with scores lower than 14 and higher or equal to 13: 2
Number of proposals with scores lower than 13 and higher or equal to 12: 1
Summary of observers’ report:
Two independent observers were asked to assist the European Health and Digital Executive Agency (HaDEA) in the evaluation of proposals submitted to 9 single and two-stage calls (covering 14 topics) with deadline on 11 April 2024, which were discussed during 2.5 weeks of consensus meetings. They followed the evaluation in order to assess and report on the implementation of the evaluation procedures, on the conduct and fairness of the evaluation process and on the application of the evaluation criteria. Based on the analysis conducted, the observers give independent advice for improvement of the evaluation process.
The evaluation process was fully transparent. The rules and guidelines to be followed were clearly communicated by documents provided to experts, by online and on-site briefings and by instructions given and, where necessary, repeated by the moderators. This ensured a fair and transparent procedure. The evaluation was conducted in an extremely fair and professional way, thanks to a thorough and meticulous preparation and to the helpful and competent HaDEA staff involved, including the quality checkers and the assistant team.
The lump sum method was used in this evaluation. Despite that the budget tables provided detailed information and that guidance was provided, many experts found it challenging assessing the proposed budgets.
The independent observers were impressed by the high quality of the evaluation, and made some further recommendations, for consideration in setting up the rules for the next framework programme. The most important advice is that a higher weight should be assigned to the Excellence criterion. It has at present a weight of 1/3 of the final score. This should be increased, as scientific excellence is the most important factor that determines the quality of a project. Such a change would be in line with international practices.
For questions, please contact the Research Enquiry Service.
[1] Proposals with the same score were ranked according to the priority order procedure set out in the call conditions (for HE, in the General Annexes to the Work Programme or specific arrangements in the specific call/topic conditions).
The Director-General responsible for the call HORIZON-HLTH-2024-DISEASE-03-two-stage, has decided to postpone the opening of this topic from 30 March 2023 to 26 April 2023.