Priorities of the year, objectives poursued and expected results
Patient registries and databases constitute key instruments to develop clinical research in the field of rare diseases, to improve patient care and healthcare planning. They are the best way of pooling data to achieve a sufficient sample size for epidemiological and/or clinical research. Indeed, registries serve as a recruitment tool for the launch of studies focusing on disease etiology, pathogenesis, diagnosis or therapy.
In the Council Recommendation of 8 June 2009 on an action in the field of rare diseases Member States committed themselves to consider supporting at all appropriate levels, including the EU level, for epidemiological purposes, registries and databases, whilst being aware of independent governance.
In order to support this process and in particular the interoperability of data in rare diseases registries the Commission decided to set up a European Platform on rare diseases registration.
As laid down in Article 12 of the Directive on the application of patients’ rights in cross-border healthcare registries will be a one of the objectives of the European Reference Networks to be set up. Therefore, only approved ERNs are eligible to be co-funded.
Description of the activities to be funded under a call for proposals
The activities to be carried out concern the creation of 3-4 new registries on rare diseases. These registries should constitute key instruments to increase knowledge on rare diseases and develop clinical research. Collaborative efforts to establish data collection and maintain them will be considered, provided that these resources are open and accessible. Registries should be built with the support and according to the standards set up by the European Platform on rare diseases registration and provide all necessary data to the Platform (taking the relevant data protection rules into account).