TRANSfusion and transplantation: PrOtection and SElection of donors

ended

Over five million patients in the EU annually receive transfusions or transplantations of substances of human origin (SoHO): blood components, plasma derived medicines, tissues & (stem) cells, germ cells for assisted reproductive technologies and organs. These treatments depend heavily on the availability of SoHO obtained from more than 13 million donors. Obviously, donor availability is the most vulnerable link in assuring these treatments. Procedures to collect SoHO, including donor selection and the actual collection or procurement, are regulated in the EU by several directives. In addition, the European Directorate for the Quality of Medicines & Health Care (EDQM) publishes recommendations (Guides) relating to the preparation, use and quality assurance of SoHO forming a basis for standard operating procedures. From this, one could infer that practice throughout Europe is harmonised. However, implementation of the directives and Guides in Member states has resulted in diverging donor selection and protection policies. Expert opinions, lacking quantitative risk-based selection criteria, and prompting a one-size-fits-all approach, have in fact lead to inflexibility and inconsistency. TRANSPOSE aims at a structured, alternative approach to construct risk-based Guidelines for the selection and protection of donors. To this end, TRANSPOSE will involve a massive pool of experts and take stock of current practices and scientific insights. TRANSPOSE may facilitate the process of revising related EU Directives. Moreover, the developed guiding principles and Donor Selection & Protection Guidelines will assist EU member states to implement policies in a consistent and clear-cut way. Finally, a standard Donor Health Questionnaire with carefully guided local/regional/national customization will become available, which can be used widely and will enable comparisons between Member States on the prevalence of certain risks and risky behaviours throughout Europe.