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Call key data

European Partnership on Rare Diseases

Call number

HORIZON-HLTH-2023-DISEASE-07-01

deadlines

Opening
12.01.2023

Deadline
19.09.2023 17:00

Funding rate

50%

Call budget

€ 100,000,000.00

Estimated EU contribution per project

€ 50,000,000.00

Link to the call

ec.europa.eu

Link to the submission

ec.europa.eu

Call content

Call objectives

The Partnership should contribute to priorities of the “Communication on effective, accessible and resilient health systems” (COM(2014) 215 final), the “Communication on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society” (COM(2018) 233 final) and support the objectives of the new EU4Health Programme (COM(2020) 405 final, Regulation (EU) 2021/522).

This partnership should also contribute to achieving the objectives of the Pharmaceutical Strategy for Europe, in terms of fulfilling unmet medical needs (e.g. for rare diseases with so called “orphan medicinal products”) and ensuring that the benefits of innovation reach patients in the EU.

Thanks to its capacity to bring together different stakeholders (e.g. research funders, health authorities, healthcare institutions, innovators, policymakers), the Partnership will create a critical mass of resources and to implement a long-term Strategic Research and Innovation Agenda (SRIA).

The co-funded European Partnership on rare diseases should be implemented based on the priorities identified in the SRIA and through a joint programme of activities ranging from coordinating and funding transnational research to highly integrative and community-driven ‘in-house’ activities such as innovation strategies for the efficient exploitation of research results, EU clinical trial preparedness activities, optimisation of research infrastructures and resources, including networking, training and dissemination activities. It should be structured along the following main objectives:

  • Launch joint transnational calls for RD research and innovation priorities as defined in the SRIA, resulting in financial support to third parties, based on the annual work plans;
  • Develop a European Clinical Research Network to accelerate the clinical trial readiness of the RD research community in Europe, to improve the research and innovation potential of RD stakeholders and facilitate the cost-effective clinical development of new therapies;
  • Develop and consolidate the capacity building of the RD data ecosystem by supporting the federated access/sharing of FAIR research data, information resources to ensure the effective and fast translation of the research results to safe and effective health innovations;
  • Integrate basic, pre-clinical and clinical research to reduce the burden for people living with a rare disease.
  • Support research in relevant medical fields and intervention areas (prevention, diagnosis, treatment), while improving the utilisation of existing health technologies in clinical practice;
  • Support the scientific work of the International Rare Disease Research Consortium.

The Partnership is open to all EU Member States, as well as to countries associated to Horizon Europe and will remain open to third countries wishing to join. The Partnership should include or engage with the following actors:

  • Ministries in charge of R&I policy, as well as national and regional R&I and technology funding agencies and foundations;
  • Ministries in charge of health and care policy, as well as national and regional healthcare authorities, organisations and providers (including providers members of the European Reference Networks);
  • Research infrastructures;
  • Patients organisations;
  • Industry;
  • Charities.

The Partnership may also encourage engagement with other relevant Ministries and research funders. It should involve other key actors from civil society and end-users, research and innovation community, innovation owners, health and care systems owners/organisers and health and care agencies.

The Partnership’s governance structure should enable an upfront strategic steering, effective management and coordination, daily implementation of activities and ensure the use and uptake of the results. Importantly, the EU Member States, as public funders should have a leading role in the governance and strategic steering of the whole Partnership, including in the co-design and the strategic orientations of the ‘in-house’ activities, such as consolidating the research & innovation ecosystem, clinical trial preparedness for the community, contribution to ERA, training activities etc.). Moreover, the management structure should allow the coordinated input of key stakeholders, including but not limited to the research and innovation community, patients and citizens, health and care professionals, formal and informal care organisations, and innovation owners.

To ensure coherence and complementarity of activities and leverage knowledge and investment possibilities, the Partnership is expected to establish relevant collaborations with other Horizon Europe partnerships (institutionalised and co-funded) and missions as set out in the working document on ‘Coherence and Synergies of candidate European Partnerships under Horizon Europe’ as well as to explore collaborations with other relevant activities at EU and international level. The proposal should also consider synergies with EU programmes, including but not limited to EU4Health, the Digital Europe Programme (DIGITAL), the European Social Fund Plus (ESF+), the European Regional Development Fund (ERDF), InvestEU, the Recovery and Resilience Facility (RRF) and the Technical Support Instrument (TSI).

Cooperation with international organisations, and non-European institutions and experts may be considered. Participation of third countries is encouraged. Their commitments to the Partnership would not be eligible for the calculation of EU funding. Applicants should describe in their proposal the methodology for their collaboration and the aims they want to achieve with this kind of collaboration.

Proposals should pool the necessary financial resources from the participating national (or regional) research programmes with a view to implementing joint calls for transnational proposals resulting in grants to third parties. Financial support provided by the participants to third parties is one of the activities of this action in order to be able to achieve its objectives.

Collaboration with the EU agency involved in authorising orphan medicinal products, the European Medicines Agency (EMA), should be considered to enhance the sharing of knowledge and data regarding orphan medicinal products and rare diseases, while national agencies producing knowledge on orphan medicinal products and rare diseases may also join the Partnership, e.g. as beneficiaries.

When defining calls for proposals, this Partnership needs to consider 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.

Collaboration with the European Commission's Joint Research Centre (JRC) must be considered to materialise the sharing of (meta)data regarding registries for rare diseases, exchanging data for clinical studies and research based on a unified pseudonymisation tool provided by the European Platform on Rare Disease Registration (EU RD Platform) and related tools and services, as well as in other areas of mutual interest, such as training and capacity building.

The total indicative budget for the partnership is up to EUR 150 million and subject to the effective implementation of the commitments made by the members of the consortium. The Commission envisages to include new actions in its future work programmes to provide continued support to the partnership for the duration of Horizon Europe.

The expected duration of the partnership is seven to ten years.

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Expected effects and impacts

Expected results

  • The EU is reinforced as an internationally recognised driver of research and innovation in rare diseases (RD) and thereby substantially contributing to the achievement of the Sustainable Development Goals related to rare diseases;
  • Research funders align, adopt and implement their RD research policies allowing for the optimal generation and translation of knowledge into meaningful health products and interventions responding to the needs of people living with a rare disease across Europe and globally.
  • The RD research community at large benefit from and use an improved comprehensive knowledge framework integrating the EU, national/regional data and information infrastructures to improve translational research.
  • People living with a rare disease benefit from a more timely, equitable access to innovative, sustainable and high-quality healthcare, taking stock of highly integrated research and healthcare systems.
  • Researchers, innovators - as well as people living with a rare disease and their advocates (as co-creators) - effectively constitute and operate into an integrated research and innovation ecosystem to deliver cost-effective diagnosis and treatments.
  • Public and private actors, including civil society (e.g. NGOs, charities), establish coordinated and efficient multi-stakeholder collaborations at EU and national (including regional) levels, allowing for more effective clinical research, for example aiming at improved success rates of therapeutic development.

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Eligibility Criteria

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), Iceland (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)

Mandatory partnership

Yes

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. Because the US contribution will be considered for the calculation of the EU contribution to the partnership, the concerned consortium of research funders from eligible EU Members States and Associated Countries must expressly agree to this participation.

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.

Additional information

Topics

Administration & Governance, Institutional Capacity & Cooperation, 
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)

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 70 pages.

Beneficiaries may provide financial support to third parties. The support to third parties can only be provided in the form of grants. Financial support provided by the participants to third parties is one of the primary activities of the action in order to be able to achieve its objectives. Given the type of action and its level of ambition, the maximum amount to be granted to each third party is € 10,000,000.00. 

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.

Call documents

HE-Work Programme 2023-2024, Cluster 1, Destination 4HE-Work Programme 2023-2024, Cluster 1, Destination 4(379kB)

Contact

National Contact Points for Horizon Europe
Website

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