European Partnership on Rare Diseases (ERDERA) (Phase 2)

The European Partnership on Rare Diseases (ERDERA) Phase 2 represents a significant EU funding opportunity under the Horizon Europe Program. This initiative focuses on enhancing and expanding research and innovation related to rare diseases, addressing critical unmet medical needs for approximately 30 million people in Europe affected by these conditions.

Eligible applicants primarily include the coordinator of the existing ERDERA consortium, which comprises over 170 organizations across 37 countries. Although the pre-existing consortium serves as the main applicant, additional partners can be integrated to broaden research efforts. Participation is open to entities from EU Member States, Horizon Europe Associated Countries, and, upon agreement from the consortium, legal entities established in the United States.

The funding structure entails a grant mechanism with a total estimated budget of €91.3 million allocated specifically for the 2026-2027 period. This funding encompasses a 50% reimbursement rate of eligible costs, prompting co-funding requirements that necessitate contributions from partner organizations and national research funders. The maximum financial support available for third parties is set at €10 million.

The application process is a single-stage submission, with all proposals due by September 15, 2026. The proposal must be submitted electronically by the existing consortium's coordinator and should detail additional activities and partners that align with the strategic goals of the partnership.

Successful applicants will receive monetary support to implement partnership activities, including direct grants for research funding and provisions for financial support to third parties. The anticipated outcomes emphasize improving the integration of research and innovation across multiple phases, enhancing clinical research, advancing data ecosystems, and supporting patient access to treatment.

Overall, this funding opportunity aims to fortify the EU's role in rare disease research, offering a vital platform for collaborative innovation and effective healthcare solutions within a specialized framework focused on addressing rare diseases through coordinated, multi-stakeholder efforts.

The HORIZON-HLTH-2026-02-DISEASE-12 call, also known as the European Partnership on Rare Diseases (ERDERA) Phase 2, is a HORIZON-COFUND action under the Horizon Europe Programme, specifically within the Partnerships in Health (2026/1) call. It aims to support activities that contribute to tackling diseases and reducing disease burden, with a focus on rare diseases. The call operates under a single-stage submission model. The planned opening date is 10 February 2026, and the deadline for submission is 15 September 2026 at 17:00:00 Brussels time. The total budget allocated for this topic is EUR 91,300,000, with EUR 42,600,000 budgeted for 2027 and EUR 48,700,000 for 2026. The indicative number of grants to be awarded is approximately 1.

The expected outcomes of this call are multifaceted. The EU should be reinforced as an internationally recognized leader in rare disease research and innovation, contributing significantly to achieving Sustainable Development Goals related to rare diseases. Research funders are expected to align and implement their rare disease research policies, optimizing the translation of knowledge into effective health products and interventions. The rare disease research community should benefit from an improved knowledge framework and cross-border data access, including rare disease registries, by integrating EU, national, and regional data infrastructures. People living with rare diseases, including underrepresented communities, should experience more timely and equitable access to innovative, sustainable, and high-quality healthcare. Researchers, innovators, patients, and advocates should form an integrated research and innovation ecosystem to deliver cost-effective diagnosis and treatments. Public and private actors should establish coordinated multi-stakeholder collaborations at EU and national levels to enhance clinical research and therapeutic development.

The scope of this call involves adding activities to existing grant agreements under Article 24(2) of the HE Regulation, potentially including new partners. The grant award will be based on a proposal from the coordinator of the consortium funded under HORIZON-HLTH-2023-DISEASE-07-01, with the additional activities subject to evaluation. The proposal should present these activities as grant agreement revisions. The existing European Rare Diseases Research Alliance (ERDERA) will be enhanced and enlarged, building on the current consortium's expertise and coverage. The proposal should detail specific additional activities and partners for the partnership's second phase. The partnership should align with the priorities of communications related to effective health systems, digital transformation in health and care, the European Health Union, and support the EU4Health Programme. It should also contribute to the Pharmaceutical Strategy for Europe, addressing unmet medical needs and catalysing the development of medicines for rare diseases, ensuring research benefits reach patients in the EU and associated countries. The partnership should align with Directive 2911/24/EU on patients’ rights in cross-border healthcare and the European Health Data Space (EHDS). The partnership aims to strengthen the European Research Area, consolidate the research and innovation ecosystem, and implement a long-term Strategic Research and Innovation Agenda (SRIA).

The co-funded European Partnership on Rare Diseases should be implemented based on the SRIA priorities. This includes a joint program of activities ranging from coordinating and funding transnational and clinical research to integrative activities such as innovation strategies, clinical trial preparedness, and optimization of research infrastructures. Proposals should build on the first phase of the partnership and be structured around key objectives. These objectives include launching joint transnational calls for research and innovation, establishing a European Clinical Research Network (CRN) to boost clinical trial readiness, advancing the capacity building of the rare disease data ecosystem, integrating basic, pre-clinical, clinical, and implementation research, supporting research and innovation across key intervention areas, and contributing to the International Rare Disease Research Consortium (IRDiRC).

The call requires the effective contribution of social sciences and humanities (SSH) disciplines and experts to enhance the societal impact of research activities. Collaboration with the European Commission's Joint Research Centre (JRC) is encouraged for sharing data, exchanging data for clinical studies, and using the European Platform on Rare Disease Registration (EU RD Platform).

Admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form available in the Submission System. 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-2023-DISEASE-07-01. Legal entities from the United States of America are eligible for Union funding, subject to agreement by the consortium of research funders. The Joint Research Centre (JRC) may participate as a beneficiary with zero funding or as an associated partner. Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.

The evaluation will consider the existing context and the scope of the initial evaluation. If successful, grant agreement amendment preparations will follow. The coordinator of the HORIZON-HLTH-2023-DISEASE-07-01 consortium will be invited to submit an amendment to the grant agreement. Award criteria, scoring, and thresholds are described in Annex D of the Work Programme General Annexes. The thresholds for each criterion (Excellence, Impact, Implementation) will be 4, with a cumulative threshold of 12. Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual. The indicative timeline for evaluation and grant agreement is described in Annex F of the Work Programme General Annexes.

The action will be implemented through an amendment of the grant agreement under Article 24(2) of the Horizon Europe Regulation. The funding rate is 50% of 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. The granting authority may object to a transfer of ownership or exclusive licensing of results up to 4 years after the action's end. Legal and financial set-up are described in Annex G of the Work Programme General Annexes.

Application and evaluation form templates, guidance documents, model grant agreements, and call-specific instructions are available in the Submission System and through provided links.

In summary, this call aims to enhance the European Partnership on Rare Diseases by adding activities and partners to the existing ERDERA consortium. It focuses on improving research, data access, clinical trials, and innovation in rare disease treatments, aligning with EU health priorities and contributing to global rare disease research efforts. The call is structured as a co-fund action, requiring a 50% funding rate and allowing for significant financial support to third parties. The submission process is single-stage, with a deadline in September 2026. The coordinator of the existing HORIZON-HLTH-2023-DISEASE-07-01 consortium is the primary applicant, with the possibility of including additional partners.

Eligible Applicant Types: The eligible applicant type is primarily a consortium. Specifically, the proposal must be submitted by the coordinator of the consortium funded under topic HORIZON-HLTH-2023-DISEASE-07-01: “European Partnership on Rare Diseases”. While the existing consortium is the primary applicant, the inclusion of additional partners is explicitly permitted and encouraged. The Joint Research Centre (JRC) may participate as a member of the consortium or as an associated partner. Legal entities established in the United States of America are also eligible to receive Union funding, subject to agreement by the EU Members States and Associated Countries consortium. The text also mentions various stakeholders, including research funders, health authorities, healthcare institutions, innovators, policymakers, civil society (e.g., Non-Governmental Organisations, charities), and people living with rare diseases and their advocates, suggesting that these entities can be involved in the broader partnership, although the direct applicant is the specified consortium.

Funding Type: The funding type is a grant, specifically a HORIZON-COFUND action. This mechanism involves co-funding, where the EU provides a grant to support a partnership, and the partners themselves contribute additional resources, including in-kind contributions. The action is intended to be implemented in the form of an amendment of the grant agreement concluded pursuant to Article 24(2) of the Horizon Europe Regulation. Beneficiaries may provide financial support to third parties (FSTP) in the form of grants.

Consortium Requirement: A consortium is required, although the call is specifically targeted towards the coordinator of an existing consortium. The coordinator of the consortium funded under topic HORIZON-HLTH-2023-DISEASE-07-01: “European Partnership on Rare Diseases” must submit the proposal. However, the inclusion of additional partners is explicitly allowed and encouraged to enhance the partnership.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes EU Member States, Horizon Europe Associated Countries, and, under specific conditions, the United States of America. The text refers to "EU and the Associated Countries" multiple times, indicating that these are the primary beneficiaries. 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.

Target Sector: The primary target sector is health, specifically research and innovation related to rare diseases. The program aims to tackle diseases and reduce disease burden, focusing on unmet medical needs, clinical development of medicines for rare diseases (orphan medicinal products), and ensuring the benefits of research and innovation reach patients. It also involves elements of digital transformation of health and care, pharmaceutical strategy, and the European Health Data Space (EHDS). The program also requires the effective contribution of social sciences and humanities (SSH) disciplines.

Mentioned Countries: The following countries and regions are explicitly mentioned: EU Member States, Horizon Europe Associated Countries, United States of America.

Project Stage: The project stage is primarily focused on the continuation and enhancement of an existing partnership. The call aims to add additional activities to existing grant agreements, suggesting that the projects are already in the implementation or development phase. The activities range from coordinating and funding transnational and clinical research to innovation strategies, clinical trial preparedness, and optimisation of research infrastructures, indicating a focus on development, validation, and demonstration stages.

Funding Amount: The total budget for the topic is EUR 91,300,000, with EUR 42,600,000 allocated for 2027 and EUR 48,700,000 for 2026. The indicative number of grants is around 1. The funding rate is 50% of the eligible costs. The maximum amount of Financial Support to Third Parties (FSTP) that may be awarded to any single third party for the duration of the partnership is set at EUR 10.00 million.

Application Type: The application type is a single-stage call for proposals. The call is specifically targeted, requiring the proposal to be submitted by the coordinator of the existing consortium.

Nature of Support: The beneficiaries will receive money in the form of a grant. The grant will support a range of activities, including research funding, coordination, networking, training, and dissemination. Beneficiaries may also provide financial support to third parties (FSTP) in the form of grants.

Application Stages: The application process involves a single stage. The evaluation will take into account the existing context and the scope of the initial evaluation as relevant, and related obligations enshrined in the grant agreement. If the proposal is successful, the next stage of the procedure will be grant agreement amendment preparations.

Success Rates: The indicative number of grants is around 1, suggesting a very low success rate.

Co-funding Requirement: Yes, co-funding is required. The funding rate is 50% of the eligible costs, meaning that the beneficiaries must provide the remaining 50% through their own resources or other sources.

Summary: This Horizon Europe call (HORIZON-HLTH-2026-02-DISEASE-12) aims to provide continued funding and support for the "European Partnership on Rare Diseases" (ERDERA). This call is specifically targeted at the coordinator of the existing consortium funded under the topic HORIZON-HLTH-2023-DISEASE-07-01. The goal is to enhance and expand the partnership by adding new activities and potentially new partners. The funding will support a wide range of activities, including transnational research calls, clinical research network development, data ecosystem advancement, and innovation uptake. The partnership should contribute to key European health objectives, such as the Pharmaceutical Strategy for Europe and the European Health Data Space. The total budget is EUR 91.3 million, with a 50% funding rate, and the call is open to entities from EU Member States, Associated Countries, and, under certain conditions, the United States of America. The application process is a single-stage submission, with a focus on amending the existing grant agreement. The program seeks to reinforce the EU's role in rare disease research and innovation, improve access to healthcare for people living with rare diseases, and foster collaboration among various stakeholders.