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EU and patient outcome data: example of convalescent plasma for COVID-19

Legal & Regulatory Affairs Committee

The EU Commission (DG SANTE, DG DIGIT, and DG CNECT) in collaboration with the European Blood Alliance and national and regional blood services is supporting a study of the use of Convalescent Plasma Transfusion to treat COVID-19. What is interesting about the project is how quickly it has been established including setting up an online registry to gather and make available data on convalescent plasma donations and patient outcomes following transfusions. The study was launched on 25 April 2020. More information here:

Patient outcomes data in the context of the regulation of tissues and cells are of increasingly interest to healthcare authorities as can be seen from the GAPP Joint Action, Work package 8, the EMA Patient Registries Initiative and the EUnetHTA Joint Action. Registries such as the EBMT can support these initiatives whereby data already reported by healthcare professionals can be further utilized – subject to legal and other obligations – for onward reporting to other stakeholders and thus reducing duplication.

We can expect to see more developments in this area in the coming year or so when the probable review of the EU Tissues and Cells directives commences and so the transplantation community should be prepared to engage with policy-makers around questions of what data, how its collected and used by whom.