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Pandemic preparedness and response: In vitro diagnostic devices to tackle cross-border health threats
|Funding Program||Horizon Europe - Cluster 1 - Destination 5: Unlocking the full potential of new tools, technologies and digital solutions for a healthy society|
|Call budget||€ 40,000,000.00|
|Estimated EU contribution per project||between € 5,000,000.00 and € 7,000,000.00|
|Link to the call||ec.europa.eu|
|Link to the submission||ec.europa.eu|
Proposals should develop and advance on new in vitro diagnostics relevant for detecting and characterising cross-border health threats and develop novel approaches to the development of medical countermeasures targeting threats identified by HERA.
As shown by the COVID-19 pandemic, infectious diseases remain a major threat to health and health security in the EU and globally, this is also the case for other health threats that can be linked for instance to terror attacks. New cross-border health threats are expected to emerge in the coming years and therefore it is essential to promote advanced research of medical countermeasures that can be used to detect, prevent and treat in case of a new health emergency. One of the most important aspects in crisis preparedness times is to ensure the availability of diagnostics that can contribute to detecting and characterising health threats.
Proposals should cover pathogens with pandemic potential in humans or other health threats, such as chemical, radiological and nuclear threats for which there are no existing diagnostics or where clinical practice could benefit from innovation. Emphasis should be put on the development of new diagnostics, innovative catch-all methodologies, or on the improvement of existing health technologies advancing diagnostics and characterisation of health threats, applying the One Health approach when relevant.
Proposals should aim to diversify and accelerate the global diagnostic research and development pipeline to tackle cross-border health threats, and to strengthen the current leading role of the EU in research and development, and therefore contributing to the work of the European Health Emergency Preparedness and Response Authority (HERA).
Attention should be paid to critical social factors such as sex, gender, age, socio-economic factors, ethnicity/migration, and disability.
Proposals should include a clear regulatory path to market in order to ensure future compliance with the legal requirements. Proposals should address several of the following areas:
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.
Proposals should consider the involvement of the European Commission's Joint Research Centre (JRC) in regard to its experience on the performance evaluation of in vitro diagnostic devices, with respect to the value it could bring in providing an effective interface between research activities and regulatory aspects and/or to translating research results into validated test methods and strategies fit for regulatory purpose. In that respect, the JRC will consider collaborating with any successful proposal and this collaboration, when relevant, should be established after the proposal’s approval.
Applicants 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.
|Expected effects and impacts|
|Regions / countries for funding||EU Member States, Overseas Countries and Territories (OCT)|
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Island (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom
|eligible entities||EU Body, Education and training institution, International organization, Natural Person, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)|
To be eligible for funding, applicants must be established in one of the following countries:
Applications may be submitted by one or more legal entities, which may be established in a Member State, Associated Country or, in exceptional cases and if provided for in the specific call conditions, in another third country.
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.
Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.
A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.
The Joint Research Centre (JRC) may participate as member of the consortium selected for funding.
|other eligibility criteria|
If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).
Digitalisation, Digital Society, ICT,
Disaster Prevention, Resilience, Risk Management,
Health, Social Services, Sports
|Relevance for EU Macro-Region||EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region|
|UN Sustainable Development Goals (UN-SDGs)|
All proposals must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.
Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.
The application form will have two parts:
Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).
The limit for a full application (Part B) is 45 pages.
The award criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
The rules for the legal and financial set-up of the grant agreements are described in General Annex G. The following exceptions apply: In order to optimise synergies and increase the impact of the projects, all projects selected for funding from this topic will form a cluster and be required to participate in common networking and joint activities (and in determining modalities for their implementation and the specific responsibilities of projects). Depending on the scope of proposals selected for funding, these activities may include:
|Call documents|| HE-Work Programme 2023-2024, Cluster 1, Destination 5 (481kB)
|Contact||National Contact Points for Horizon Europe |
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