Production of plasma-derived medicinal products: ethical implications for blood donation and donors.

Abstract

It is not only useless, but probably also tactless to remind a meeting of haematology experts of the importance of blood. But its relevance is such that a reminder is nonetheless useful. Two definitions of blood significantly reveal a glaring contrast: blood “est synonyme de vie, de force, de sante, de noblesse, de descendance”, while at the same time blood “represente la maladie, la mort e la guerre, les maladies hereditaires, l'etranger et la haine raciste”1. Another of the numerous examples of this contrast is to be found in the laws relating to “limpieza de sangre” enacted in Spain between the fifteenth and sixteenth centuries and so well described by David Biale, Professor of Jewish history, in “Blood and belief: the circulation of a symbol between Jews and Christians”2. Even when it is not directly paid for, a complex global network of trade in biological material ensures that the donation of blood involves the movement of large sums of money, albeit not for profit. Some authors have likened this material to a sort of “corporeal currency”. Roberto Esposito, for example, coined the expression “immunitary paradigm” in which immunity has become the basis of a “bioeconomic flow, circulation and exchange”3. It is also worth recalling that the words “immunitas” and “communitas”, while having profoundly different meanings, nonetheless share a common etymological root, “munus”, meaning both “gift” and “obligation”. “Communitas” means sharing, reciprocity, while “immunitas”, whether used in biomedical or in legal contexts, means closure, a resistance to reciprocity, protection against sharing. For the purposes of the present considerations, both can refer to the notion of “gift relationship” coined by Richard Titmuss4. The donation of umbilical cord blood is a demonstration of altruism that could perhaps restore some kind of harmony between the two concepts5. In the specific case of plasma-derived products, on the 12th April, 2012, the Italian Ministry for Health enacted four new decrees regarding: the processing of plasma collected in Italy; the import and export of human blood and blood-derived products; the marketing of products derived from human plasma, and the presentation and assessment of applications for registration as centres or companies authorised to enter into agreements with local governments for the processing of plasma6–9. As with many bioethical issues, it is helpful to address the question using a triangular approach. The first -and perhaps most important- side of the triangle is represented by technical-scientific data. “Bad science, bad ethics”: the first requisite for ethics is a sound scientific base. The second side of the triangle is represented by the values at stake; and the third side by the ethical evaluation that springs from the first two. The first consideration will be omitted here: it is not the bioethicist’s job to illustrate the technical-scientific aspects of blood to an audience of experienced haematologists. Instead, I shall consider the second and third sides of the triangle.

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