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).

Budget

The total indicative amount of the present call is EUR 1.200.000. In line with the text of thefunding decision (Annual Work Programme 2016) which foresees the creation of 3-4 newregistries, the indicative budgetary ceiling per grant to be awarded in 2017 is EUR 400.000.

Duration

The maximum duration of a project is 36 months.

Eligibility

Applicants participating in a project proposal have to be different legal entities (i.e. independentfrom each other) from at least 3 countries participating in the Health Programme. Proposals whichinvolve fewer applicants will be rejected.