Dr.Jean Mercier Ythier is working as a professor in Sorbonne University in France.
Abstract
Significant R&D investment is currently being made in the design of cost-effective devices for the manufacture of red blood cells (RBCs) from hematopoietic stem cells. Recent technological advances open perspectives for the for-profit manufacture of homologous transfusion products for alloimmunized patients, at production costs less than 1,500 euros/cRBC unit in realistic scale facilities. Stem cell lines from scarce phenotypes of universal donors will gain substantial economic value as basic assets of this new bio-industry. This paper addresses a number of issues related to this predictable consequence of the development of an RBC industry. The main strands of case law and legal literature related to cell line patents are reviewed and their applicability to putative RBC manufacturing is discussed. I examine the various conceivable patterns of compensation for stem cell donors, from full-market compensation to full-free (i.e., uncompensated) donation, and discuss their respective relevance for the collection of suitable cell lines and for the development of the industry.
