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Background

The interest of researchers in the establishment of disease registries, is shown by the increasing number of RD registers in EU Member States as national or local initiatives mainly located at universities (Orphanet, 2009). Applications for funding RD networks, promoting data sharing and collaboration among researchers, are also submitted regularly to the European Commission.

The need for shared quality data collections for different health and healthcare purposes and the awareness of difficulties posed by their maintenance is witnessed by a number of recent documents (EPPOSI, 2009; Pharmaceutical Forum Reports, 2008).

The recent adoption of the Council Recommendation on RDs, which recommends the development of registers and databases for epidemiological purposes, is expected to result in a burst of initiatives for RD registration.
While a wide population base is especially needed for epidemiological and clinical research in RDs, the Regulation on personal data protection creates important challenges to EU data collection and exchange, requiring a legitimate purpose for health data collection. It is therefore urgent to set up a common regulatory, ethical and technical framework to avoid that spontaneous initiatives in EU Countries find sound but autonomous solutions and legal bases, resulting in a waste of time, resources and health.

Aim of the present study is to carry out a feasibility study addressing regulatory, ethical and technical issues associated with the registration of RD patients and with the creation of a EU platform for the collection of data on RD patients and their communication among qualified users. Possibilities for long-term sustainability of registration in the platform will also be studied by seeking synergies among different interests like research, health technology assessment, management of healthcare and policy purposes.

To this aim, the project will define options for the preparation of a legal basis, fields in which effective synergies can be achieved, governance framework and possible options to support the platform either financially or by hosting it in an organization or a Community institution. The feasibility of a minimum data set common to all rare diseases designed to inform policy-making also will be assessed.

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