European partnership fostering a European Research Area (ERA) for health research (Phase 2)

The ERA4Health Partnership (Phase 2) is a Horizon Europe initiative aimed at enhancing transnational collaboration in health research focused on addressing critical public health needs. This program will support joint programming and funding to tackle diseases, particularly non-communicable diseases such as cardiovascular and lifestyle-related illnesses, as well as areas like nanomedicine. The program encourages participation from public research funders, philanthropic organizations, and other relevant health research entities in EU member states and associated countries.

Eligible applicants include public funders at national and regional levels, universities, research institutes, and nonprofits engaged in health research and innovation. The funding type is primarily a grant, specifically under the HORIZON-COFUND action, indicating a co-funded initiative where the EU matches resources pooled from participating research institutions. A consortium of multiple funders must collaborate, allowing for additional partners.

Geographic eligibility extends to EU member states, associated countries, and certain third countries, fostering international collaboration. The focus is on health research with an emphasis on clinical studies and public health interventions. The total budget commitment for the partnership exceeds €90 million for the initial phase and is projected to exceed €150 million in Phase 2. The program will support a range of project stages from preclinical research to large-scale clinical trials.

Applications will undergo a single-stage open call process, with a deadline set for June 3, 2025. The nature of support includes monetary grants for third-party projects, with a co-funding requirement from national or regional funders. The expected success rate for proposals is not explicitly stated but typically falls between 10% and 39% due to high competition.

Overall, the ERA4Health Partnership aims to improve public health outcomes in Europe by fostering collaboration among research funders, policymakers, and the research community, ultimately leading to the development and integration of effective health interventions across healthcare systems.

This is a Horizon Europe call for proposals under the Partnerships in Health (2025) program, specifically targeting the continuation of the European partnership fostering a European Research Area (ERA) for health research (ERA4Health) into its second phase. The call, HORIZON-HLTH-2025-02-DISEASE-02, is a HORIZON-COFUND action, meaning it is a co-funded initiative where the EU provides funding to complement national or regional funding programs. The call aims to support activities that contribute to "Tackling diseases and reducing disease burden." The expected outcomes include improved collaboration between research funders, health policymakers, and the research community; generation of knowledge related to cardiovascular diseases, prevention and public health, diet-related diseases, and nanomedical technologies; support for testing health interventions in clinical settings at the European level through multi-country Investigator-Initiated Clinical Studies (IICSs); more effective and integrated public health research systems; use of research results by health authorities and policymakers to develop evidence-based strategies and policies; more knowledgeable patients and citizens contributing to patient-centered decision-making; and better cooperation between countries to make health and care systems more sustainable and resilient.

The scope of the call is to address the need for more efficient health research at the EU and Associated Countries level, delivering safer, better, and higher-quality solutions for prevention, detection, diagnosis, treatment, and management of diseases. It builds upon the existing ERA4Health partnership (Grant Agreement: 101095426), which started in November 2022 and involves 33 entities from 22 countries. Phase 1 activities included organizing Joint Translational Calls (JTCs) and preparing a framework for multi-country IICS. The current call is a continuation of the topic HORIZON-HLTH-2022-DISEASE-03-01 and aims to amend the existing grant agreement to include additional activities and partners. The main activities of ERA4Health in Phase 2 will focus on additional JTCs on multi-country IICS in well-defined priority areas, while continuing activities initiated in Phase 1. Phase 2 objectives include updating and implementing the Partnership’s long-term Strategic Research and Innovation Agenda, enlarging activities related to non-commercial clinical studies, and providing support and building capacity for conducting multi-country IICSs at the European scale.

All types of clinical studies falling under the Clinical Trials Regulation (EU) 536/2014, including low-interventional trials, may be supported. Proposed multi-country IICSs should establish new indications for existing health interventions, optimize or develop new personalized care pathways, support the development of new health interventions, and accelerate the uptake of new interventions by healthcare systems. The partnership will leverage existing research infrastructures like ECRIN and BBMRI. The partnership is open to public funders of health research at national and regional levels in Member States, countries associated to Horizon Europe, and other health research funders such as philanthropic organizations. It encourages engagement with Ministries in charge of R&I and health and care policy, as well as other key actors from civil society, the research and innovation community, and health and care systems. Cooperation with international organizations and third countries is also encouraged. The proposal should pool financial resources from participating research programs to implement joint calls for transnational proposals, resulting in grants to third parties. The partnership needs to consider sex and gender-related differences and the effective contribution of social sciences and humanities (SSH) disciplines. The expected duration of Phase 2 should not exceed nine years.

The call is a single-stage submission process, with the opening date on 13 May 2025 and the deadline on 03 June 2025 at 17:00:00 Brussels time. The total budget for the HORIZON-HLTH-2025-02-DISEASE-02 topic is 77,000,000 EUR. The indicative number of grants is 1. For the HORIZON-HLTH-2025-02-DISEASE-01 topic, the budget is 47,000,000 EUR in 2027, 46,500,000 EUR in 2026, and 56,500,000 EUR in 2025. The indicative number of grants is 1.

The admissibility conditions, proposal page limits, and layout are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes and Part B of the Application Form. Eligible countries are described in Annex B of the Work Programme General Annexes. The proposal must be submitted by the coordinator of the consortium funded under topic HORIZON-HLTH-2022-DISEASE-03-01. The EU contribution of Phase 2 devoted to funding multi-country Investigator-Initiated Clinical Studies must be between 60% and 70% of the EU contribution of Phase 2. Legal entities established in the United States of America are eligible to receive Union funding. Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. Evaluation and award criteria, scoring, and thresholds are described in Annex D of the Work Programme General Annexes. The thresholds for each criterion will be 4 (Excellence), 4 (Impact), and 4 (Implementation), with a cumulative threshold of 12. Submission and evaluation processes and the indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes and the Online Manual.

The action will be implemented as an amendment to the grant agreement under Article 24(2) of the Horizon Europe Regulation. The funding rate is 30% of the eligible costs. Beneficiaries may provide financial support to third parties (FSTP) in the form of grants, with a maximum amount of EUR 10.00 million per third party for the duration of the partnership, which may be higher if duly justified. The starting date of the grant may be as of the submission date of the application, with applicants needing to justify the need for a retroactive starting date. Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.

The application and evaluation forms include a standard application form (HE COFUND top-up) and a standard evaluation form (HE COFUND). Guidance is provided in the HE Programme Guide, Model Grant Agreement (MGA), and call-specific instructions. Additional documents include the HE Main Work Programme 2025, HE Framework Programme 2021/695, EU Financial Regulation 2024/2509, and other related documents.

This funding opportunity aims to bolster health research across Europe by providing continued support to the ERA4Health partnership. It seeks to foster collaboration, pool resources, and fund transnational clinical studies, ultimately leading to improved healthcare solutions and policies. The call is specifically targeted towards the existing ERA4Health consortium, allowing them to expand their activities and include new partners in their mission to address public health needs through impactful multinational research collaborations. The emphasis is on investigator-initiated clinical studies, ensuring that research is driven by public health benefits rather than commercial interests.

Eligible Applicant Types: The eligible applicant types for this opportunity include public funders of health research at both national and regional levels in the Member States, countries associated to Horizon Europe, and other health research funders such as philanthropic organisations. The partnership also seeks engagement with Ministries in charge of R&I policy, national and regional R&I and technology funding agencies and foundations, Ministries in charge of health and care policy, and national and regional health and care authorities, organisations, and providers. The partnership will involve other key actors from civil society and end-users, the research and innovation community, innovation owners, health and care systems owners/organisers, and health and care agencies. Cooperation with international organisations, non-European institutions, and experts is also considered, and participation of third countries is encouraged.

Funding Type: The primary financial mechanism is a grant, specifically a HORIZON-COFUND action. This involves co-funding, where the EU provides funding to match resources pooled from participating research programmes. The action also involves providing financial support to third parties (FSTP) in the form of grants.

Consortium Requirement: The proposal must be submitted by the coordinator of the consortium funded under topic HORIZON-HLTH-2022-DISEASE-03-01. However, the inclusion of additional partners is possible. Therefore, it is a consortium with the possibility of adding more partners.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes Member States, countries associated to Horizon Europe, and third countries. The partnership is open to public funders of health research at both national and regional levels in the Member States and countries associated to Horizon Europe. Participation of third countries is encouraged. 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.

Target Sector: The target sector is health research, specifically focusing on tackling diseases and reducing disease burden. The program targets areas such as cardiovascular diseases, prevention and public health, diet-related diseases, and nanomedical technologies. It also supports clinical studies, including low-interventional trials, and aims to optimise care pathways, develop new health interventions, and accelerate the uptake of new interventions by healthcare systems.

Mentioned Countries: United States of America, EU Member States, countries associated to Horizon Europe, and third countries.

Project Stage: The project stage is primarily focused on the continuation and expansion of existing activities from Phase 1, with an emphasis on additional Joint Transnational Calls (JTCs) on multi-country Investigator-Initiated Clinical Studies (IICS) in well-defined priority areas. The project supports activities ranging from research to clinical studies and the uptake of new interventions by healthcare systems.

Funding Amount: The indicative budget for HORIZON-HLTH-2025-02-DISEASE-01 is 56,500,000 EUR in 2025, 46,500,000 EUR in 2026 and 47,000,000 EUR in 2027. The indicative budget for HORIZON-HLTH-2025-02-DISEASE-02 is 77,000,000 EUR. The EU funding rate is 30% of the eligible costs. The maximum amount to be granted to each third party is EUR 10.00 million for the duration of the partnership, although this amount may be higher if duly justified.

Application Type: The application type is a single-stage open call.

Nature of Support: Beneficiaries will receive money in the form of grants. Financial support is also provided to third parties (FSTP) in the form of grants.

Application Stages: The application process is a single-stage process.

Success Rates: There is one grant expected for HORIZON-HLTH-2025-02-DISEASE-01 and one grant expected for HORIZON-HLTH-2025-02-DISEASE-02.

Co-funding Requirement: Yes, this is a co-funded action, meaning that the EU funding is intended to be matched by financial resources from the participating research programmes. The funding rate is 30% of the eligible costs.

Summary:
This Horizon Europe COFUND action, HORIZON-HLTH-2025-02-DISEASE-01 and HORIZON-HLTH-2025-02-DISEASE-02, aims to continue and expand the ERA4Health partnership, fostering a European Research Area for health research. It supports activities that contribute to tackling diseases and reducing disease burden by promoting collaboration among research funders, policymakers, and the research community. The primary focus is on supporting multi-country Investigator-Initiated Clinical Studies (IICS) to test health interventions and improve healthcare systems. The call is specifically targeted at the coordinator of the consortium funded under the previous topic HORIZON-HLTH-2022-DISEASE-03-01, with the possibility of including additional partners. The funding is open to public funders of health research, ministries, and other relevant stakeholders in the EU, associated countries, and third countries, including the United States. The EU provides a 30% funding rate, with a maximum of EUR 10 million granted to each third party, and the expected duration of Phase 2 should not exceed nine years. The application process is a single-stage open call, with a deadline of June 3, 2025. The action seeks to enhance the efficiency and integration of public health research systems, promote evidence-based strategies and policies, and empower patients and citizens in healthcare decision-making.