HORIZON EUROPE
Europeo
Specific Challenge:Despite the advances on biomedical research most of the estimated 6000 to 8000 rare diseases lack means for specific diagnosis and therapy. Small and dispersed patient populations, fragmented expertise and research resources make rare diseases a prime area for EU-level collaboration. Substantial funding from the EU Framework Programmes for Research and Innovation has had an integrating effect in the field, and three consecutive ERA-NETs have built the base for close research collaboration between Member States. European Reference Networks (ERNs[1]) established under the Directive on Patients' Rights in Cross-Border Healthcare will bring a major structuring effect on research and care by linking thematic expert centres across the EU.
There is a need to more efficiently bring the results of rare diseases research and innovation to patients in terms of new and optimised treatment options, diagnostic tools and integrated care, making sure that patients maximally benefit from the research and investments done at the EU and Member States levels.
Scope:The overall objective is to implement a European Joint Programme (EJP) Cofund for...
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Specific Challenge:Despite the advances on biomedical research most of the estimated 6000 to 8000 rare diseases lack means for specific diagnosis and therapy. Small and dispersed patient populations, fragmented expertise and research resources make rare diseases a prime area for EU-level collaboration. Substantial funding from the EU Framework Programmes for Research and Innovation has had an integrating effect in the field, and three consecutive ERA-NETs have built the base for close research collaboration between Member States. European Reference Networks (ERNs[1]) established under the Directive on Patients' Rights in Cross-Border Healthcare will bring a major structuring effect on research and care by linking thematic expert centres across the EU.
There is a need to more efficiently bring the results of rare diseases research and innovation to patients in terms of new and optimised treatment options, diagnostic tools and integrated care, making sure that patients maximally benefit from the research and investments done at the EU and Member States levels.
Scope:The overall objective is to implement a European Joint Programme (EJP) Cofund for Rare Diseases which would create a research and innovation pipeline "from bench to bedside" ensuring rapid translation of research results into clinical applications and uptake in healthcare for the benefit of patients. The initiative should follow the policies and contribute to the objectives of the International Rare Diseases Research Consortium (IRDiRC).
The specific objectives of the EJP Cofund are to improve integration, efficacy, production and social impact of research on rare diseases through the development, demonstration and promotion of sharing of research and clinical data, materials, processes, knowledge and know-how, and to implement and further develop an efficient model of financial support for research on rare diseases including basic, clinical, epidemiological, social, economic, and health service research. Reaching these objectives requires support of a wide range of activities and participants which cannot be achieved with an ERA-NET-Cofund.
The EJP Cofund should be implemented through a joint programme of activities ranging from research to coordination and networking activities, including training, demonstration and dissemination activities, to be structured along the four main components:
Research and innovation programme to be funded through transnational calls for proposals resulting in financial support to third parties, based on the annual work plans of the EJP Cofund;Development of a virtual platform for rare diseases information, research data, data based on samples, tools and standards to support and accelerate rare diseases research;Capacity building to improve the research and innovation potential of key stakeholders and enhance uptake of research results;Strategic coordination and management. The research and innovation programme should encompass various aspects of rare diseases, such as development of new means for diagnosis and screening, improved annotation and interpretation of genetic variants, functional analysis of candidate variants, animal and cellular models for human conditions, natural history studies with improved, scalable and participants-centred registries, preclinical research for new therapies, development of new methods for clinical trials, clinical trials for new and/or repurposed therapies including advanced therapies, discovery and validation of robust biomarkers, basic research into pathomechanisms and molecular pathways, social, economic and healthcare oriented studies including burden of disease studies, and health services research to improve patient outcomes and healthcare systems. The calls should be implemented on the basis of the standards and good practice for calls implemented under ERA-NET Cofund actions (international peer review, Horizon 2020 evaluation criteria, proposal selection according to the ranking list etc.).
The development of the virtual platform for rare diseases information, research data, samples, tools and standards should build on the existing resources, link directly with funded research projects and establish new connections across the rare diseases community in particular with European Reference Networks (ERNs). Pilot actions involving funded research projects, ERNs, or relevant national or regional research and care institutions should be launched to ensure the usefulness of the developed tools to be followed by upscaling in a progressive manner.
The EJP Cofund for Rare Diseases will contribute to the Health Research and Innovation Cloud, one of the thematic clouds of the European Open Science Cloud[2].
Capacity building activities should include training and support activities focussing on areas such as research data management, product development, HTA processes, translational research and defining and sharing best practice guidelines and involve large groups of stakeholders including patient organisations.
Strategic coordination and management should encompass annual programming including gap-analysis and identification of research priorities and policy questions in demand for evidence generation, as well as monitoring of the outcome of the EJP Cofund. Appropriate considerations of the relevant ethical, legal, sex/gender and societal aspects should be included. Close linkage with IRDiRC would be ensured by integration of the IRDiRC Secretariat in the EJP Cofund.
Participation of patient organisation should be encouraged in relevant activities of the EJP Cofund.
For grants awarded under this topic for EJP Cofund, beneficiaries may provide support to third parties as described in General Annex K of the Work Programme either in form of grants or prizes. The respective options of Article 15 of the Model Grant Agreement will be applied.
Financial support provided by the participants to third parties is one of the primary aims of this action. Therefore, the 60 000 EUR threshold provided for in Article 137(1)(c) of the Financial Regulation No 966/2012 and Article 210(a) of the Rules of Application Regulation No 1268/2012, does not apply .
The Commission considers that proposals requesting a contribution from the EU of between 50 and EUR 55 million would allow these challenges to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
Expected Impact: Improve lives of rare disease patients by providing new and optimised treatment options and diagnostic tools for these diseases. Decrease fragmentation of rare diseases expertise and research resources. Increase the EU's capacity to innovate in the field of rare diseases. Improve healthcare systems' capacity to take up research results. Reinforce the EU's role as a global leader for rare diseases.
Cross-cutting Priorities:Socio-economic science and humanitiesInternational cooperationGenderOpen Science
[1]https://ec.europa.eu/health/ern/policy_en
[2]https://ec.europa.eu/research/openscience/pdf/realising_the_european_open_science_cloud_2016.pdf
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Características del consorcio
:
La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
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 2020 projects. See the information in the Online Manual.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion in a single stage process will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
European Joint Programme (EJP):
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
MGA EJP Cofund – Multi-Beneficiary
Annotated Grant Agreement
Essential information for clinic... 1. Eligible countries: described in Annex A of the Work Programme.
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 2020 projects. See the information in the Online Manual.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion in a single stage process will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
European Joint Programme (EJP):
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
MGA EJP Cofund – Multi-Beneficiary
Annotated Grant Agreement
Essential information for clinical studies
6. Additional provisions:
Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.
8. Additional documents:
Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020
Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
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