Building a European innovation platform for the repurposing of medicinal products
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2021-DISEASE-04-02
- Programme
- Tackling diseases (2021)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- June 21, 2021
- Deadline
- September 20, 2021
- Deadline Model
- single-stage
- Budget
- €50,000,000
- Min Grant Amount
- €25,000,000
- Max Grant Amount
- €25,000,000
- Expected Number of Grants
- 2
- Keywords
- HORIZON-HLTH-2021-DISEASE-04-02HORIZON-HLTH-2021-DISEASE-04Health policy and servicesInnovation support servicesKnowledge and Technology transfer
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 all of the following expected outcomes:
- Researchers continue to use the platform as an effective and sustained approach to coordinate and manage their efforts on the repurposing of medicines, making the best use of scientific knowledge and resources.
- Patients have new and effective therapeutic options addressing unmet medical needs, both for communicable and non-communicable diseases.
- Health care systems and payers have available more cost-effective treatments that reduce the financial burden in the medium- to long-term.
- The public sector and the pharmaceutical industry engage in new models of sustainable collaboration, at European level and beyond.
- Policy-makers adjust the EU’s regulatory landscape for pharmaceuticals towards further harmonisation and increased fitness for purpose.
Development of therapeutics is a lengthy process that requires a large amount of efforts, time and financial resources. It is often burdened by delays and barriers that account for an average of almost 15 years until a promising candidate molecule becomes an approved medicine. It is therefore of paramount importance to define strategies that facilitate the reduction of timeframes, decrease costs and improve the success rate of this complex and lengthy process. One efficient strategy towards this direction is the repurposing of already approved medicinal products[1] and repositioning of investigational products[2] beyond their original indication. This approach has already proved successful[3] in several instances but its potential is far from having been fully exploited.
Proposals should address all of the following:
- Set up a platform[4] supporting an innovative repurposing model with a harmonized and sustainable dimension in the EU, attracting investments and taking a position of leadership at global level. This model should integrate the scientific, methodological, financial, legal, regulatory, and intellectual property aspects of the repurposing approach.
- Provide robust and transparent selection mechanisms for prioritising already approved medicinal products or investigational products for repurposing, based on recognized unmet medical needs and sound preliminary data, and identify research priorities for the better understanding of mechanisms of action.
- Leverage, pool and share existing high quality data assets in the European repurposing landscape, also by using pharmacogenomics, in silico, and artificial intelligence (AI) approaches, innovative preclinical human in vitro cellular/multi-organ validation methods, and deliver new computational tools.
- Resolve the fragmentation and lack of ownership of the repurposing approach that greatly impedes the efficient exploitation of its potential, networking existing projects[5] and initiatives in the field. Particular attention should be given in supporting and strengthening academic driven research.
- Devise and test a European innovation platform to enhance the collaboration among relevant European stakeholders, including academia, non-profit organisations, patients, health-care professionals, regulators, health technology assessment bodies, payers, industry, and European Research Infrastructures.
All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.
In order to achieve the expected outcomes, international cooperation is encouraged.
[1] Medicinal products with a market authorisation in the EU.
[2] Investigational products without a market authorisation in the EU.
[3] Notable examples are thalidomide and sildenafil.
[4] Platform built around innovative concepts and comprising the components and expertise necessary to create a solid foundation on which to build a sustainable EU infrastructure to overcome the bottlenecks and fragmentation in the field of medicine repurposing.
[5] Particular attention should be given to already EC funded repurposing projects and regulators initiatives in the field.
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 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 prevention measures, public health interventions, diagnostics, vaccines, therapies, alternatives to antimicrobials, as well as to improve existing 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 policy-making; 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 counter measures, 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).
Some research and innovation actions under Destination 3 should deliver relevant complementary inputs to the announced “Europe’s Beating Cancer Plan”[3], contributing to actions covering 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]. In particular, the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases are contained and hepatitis, water-borne diseases and other communicable diseases are being combated[10].
- 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, especially in partnership with Africa.
[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/nmh/events/ncd_action_plan/en.
[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.
[10] Target 3.3 of the UN’s Sustainable Development Goals, 2015.
Eligibility & Conditions
General conditions
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 to support its participation in projects funded under the Health cluster.
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.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
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.
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) — call-specific application form is available in the Submission System
Standard evaluation form (HE RIA, IA) — will be used with the necessary adaptations
HE General MGA v1.0
Essential Information for Clinical Studies
Additional documents:
HE Main Work Programme 2021–2022 – 1. General Introduction
HE Main Work Programme 2021–2022 – 4. Health
HE Main Work Programme 2021–2022 – 13. General Annexes
HE Programme Guide
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
We recently informed the applicants about the evaluation results for their proposals submitted under this call. The results of the evaluation are as follows:
- Number of proposals submitted (including proposals transferred from or to other calls): 253
- Number of inadmissible proposals: 5
- Number of ineligible proposals: 19
- Number of above-threshold proposals: 134
- Total budget requested for above-threshold proposals: EUR 1.017.369.826
We recently informed the applicants about the evaluation results for their proposals submitted under this call. The results of the evaluation are as follows:
- Number of proposals submitted (including proposals transferred from or to other calls): 253
- Number of inadmissible proposals: 5
- Number of ineligible proposals: 19
- Number of above-threshold proposals: 134
- Total budget requested for above-threshold proposals: EUR 1.017.369.826
Call HORIZON-HLTH-2021-DISEASE-04 closed on 21 September 2021. 253 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2021-DISEASE-04-01: 37 proposals
- HORIZON-HLTH-2021-DISEASE-04-02: 13 proposals
- HORIZON-HLTH-2021-DISEASE-04-03: 58 proposals
- HORIZON-HLTH-2021-DISEASE-04-04: 112 proposals
- HORIZON-HLTH-2021-DISEASE-04-05: 1 proposal
- HORIZON-HLTH-2021-DISEASE-04-06: 3 proposals
- HORIZON-HLTH-2021-DISEASE-04-07: 29 proposals
Evaluation results are expected to be communicated on Friday 28 January 2022 at the earliest.
Call HORIZON-HLTH-2021-DISEASE-04 closed on 21 September 2021. 253 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2021-DISEASE-04-01: 37 proposals
- HORIZON-HLTH-2021-DISEASE-04-02: 13 proposals
- HORIZON-HLTH-2021-DISEASE-04-03: 58 proposals
- HORIZON-HLTH-2021-DISEASE-04-04: 112 proposals
- HORIZON-HLTH-2021-DISEASE-04-05: 1 proposal
- HORIZON-HLTH-2021-DISEASE-04-06: 3 proposals
- HORIZON-HLTH-2021-DISEASE-04-07: 29 proposals
Evaluation results are expected to be communicated on Friday 28 January 2022 at the earliest.
Although the submission of the document titled ‘Template for essential information to be provided for proposals including clinical trials/studies/investigations/cohorts’ is not mandatory for the call topic you have accessed, if your proposal includes a clinical study (as it is defined in the template), you are encouraged to complete and submit this template as part of your grant application. Please disregard the second footnote in the template.