The revision of the European blood directives: A major challenge for transfusion medicine.

ABSTRACT

AIM: Using both patient-focused and donor-focused perspectives, to review the current EU blood directives, in order to derive proposals, in principle, for what should evolve during the revision process of these directives. METHODS: Review of the EU blood directives in the light of scientific literature, related reports from the Directorate General Health and Consumers (DG SANTÉ), and from the Council of Europe (CoE). RESULTS: The analyses led us to present the main following proposals developing voluntary unpaid donations the directives should consider taking into consideration ethically acceptable forms of compensation consistent with altruistic donation (including plasma donations for fractionation); current expertise more extensive utilization of the expertise of blood establishments and their consultants should be considered; donor selection an evidence-based approach for basing donor deferral criteria on sound scientific evidence should be promoted; donor reactions measures to prevent donor reactions and to make donations safer for the donors should also be included; quality control The quality control requirements should relate to the Council of Europe Blood Guide specifications these should become minimum standards (as is the case with monographs of the European Pharmacopeia), facilitating regular update of blood component lists and related specifications and compliance with the specifications; haemovigilance because of reporting difficulties (e.g. lack of number of blood products transfused), the effectiveness of haemovigilance has so far been limited. This should lead appropriate bodies to investigate alternative or complementary ways to help improve patient safety, taking into consideration, in principle, patient blood management and the appropriate use of blood products. Furthermore, donor vigilance, which is still absent from the current directive should be included in a revised directive. CONCLUSIONS: These proposals for revising the current EU blood directives (if taken into account and given appropriate regulatory formulation) should help to optimize patient safety and donor care, progress the compliance with the ethical principles for donors and improve the efficiency of the healthcare systems dedicated to transfusion medicine.