Evaluation of EU legislation on blood: a bioethical point of view

Abstract

A review of the European Union (EU) regulations concerning blood, tissues, and cells of human origin is under way in the EU. From the ethical point of view, the non-remuneration of donations and the ban on deriving gain from human biological materials are of particular significance. While the basic ethical principles involved in the procurement, preservation, and use of these materials are the same, their practical application should be adapted to the specific context of each material. In the case of donation and use of blood, in particular, the issue of legitimate reimbursements to donors and for transfusion centers has to be managed in accordance with the principle of non-commercialization. There is also a need for strict rules to avoid possible commercial spillover effects from blood-derived products. The author proposes ethical criteria regarding reimbursements to donors, costs associated with processing, and the development (and possible marketing) of products.