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Call key data

Pandemic preparedness and response: In vitro diagnostic devices to tackle cross-border health threats

Funding ProgramHorizon Europe - Cluster 1 - Destination 5: Unlocking the full potential of new tools, technologies and digital solutions for a healthy society
Call numberHORIZON-HLTH-2023-TOOL-05-08
deadlinesOpening
12.01.2023		Deadline
13.04.2023 17:00
Funding rate70%
Call budget € 40,000,000.00
Estimated EU contribution per projectbetween € 5,000,000.00 and € 7,000,000.00
Link to the callec.europa.eu
Link to the submissionec.europa.eu

Call content

short description

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.

Call objectives

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:

  • Proof-of-concept/early studies linked e.g. to performance evaluation of new diagnostics that facilitate screening, detection of the presence or exposure to a cross-border health threat or determination of infectious/disease status through human samples, included but not limited to the list of high impact health threats identified by HERA, as well chemical, radiological and nuclear threats for which there is a lack of in vitro diagnostics or existing diagnostics have a sub-optimal performance.
  • Data-driven diagnostic and prognostic platforms with AI and other advanced data analytics functionalities, adaptable to respond to new and multiple pathogens/threats, e.g. covering prototype viruses.
  • Innovative systems linked to high sensitivity/specificity profiles adaptable for broader use should be considered, such as portable, faster, more compact or accurate devices and technologies, including the possibility to develop point of care or self-tests.
  • Innovative diagnostics sampling methods or samples bringing a significant improvement, such as less invasive sampling methods.

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.

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Expected effects and impacts
Expected results
  • The scientific and clinical communities, including health care providers and payers, as well as regulators, health systems and patients benefit from innovative diagnostic solutions that are better suited to tackle cross-border health threats.
  • The scientific and clinical communities have access to novel and improved methodologies for detection of pathogens with pandemic potential in humans and for timely discovery of other health threats, such as chemical, radiological and nuclear threats, including considerations on detection in animals and environmental conditions (One Health approach).
  • A diverse and robust pipeline of in vitro diagnostics is available, increasing options for clinical deployment in case of an epidemic or pandemic.

Regions / countries for fundingEU 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 entitiesEU 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)
Mandatory partnershipYes
Project Partnership

To be eligible for funding, applicants must be established in one of the following countries:

  • the Member States of the European Union, including their outermost regions
  • the Overseas Countries and Territories (OCTs) linked to the Member States
  • third countries associated to Horizon Europe - see list of particpating 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.

Specific cases:

  • Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
  • Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
  • Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
  • EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
  • Joint Research Centre (‘JRC’)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
  • Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.

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).

Additional information

Topics
Digitalisation, Digital Society, ICT, 
Disaster Prevention, Resilience, Risk Management, 
Health, Social Services, Sports
Relevance for EU Macro-RegionEUSAIR - 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)
Additional Information

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:

  • Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
  • Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.

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:

  • Attendance of regular joint meetings (e.g., common kick-off meeting and annual meetings). 
  • Periodic report of joint activities (delivered at each reporting period). 
  • Common dissemination and communication activities (which may include, for example: a common dissemination and communication strategy, web portal and visual identity, brochure, newsletters). 
  • Common Data Management Strategy and Common Policy Strategy (including joint policy briefs). 
  • Thematic workshops/trainings on issues of common interest. 
  • Working groups on topics of common interest (e.g. data management, communication and dissemination, science-policy link, scientific synergies)
Call documents HE-Work Programme 2023-2024, Cluster 1, Destination 5 (481kB)
ContactNational Contact Points for Horizon Europe
Website

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