Donation of Human Biological Materials in the European Union: Commodifying Solidarity in the Era of the Biotechnological Revolution?

Abstract

The use of human biological materials (HBMs) involves a number of issues from both an ethical and a legal point of view. In recent decades, the purposes for which this material has been used have increased. The development of therapeutic products has led to the configuration of a market in which products have acquired an economic value. As soon as the private sector crosses the threshold of access to the use of human cells and tissues, a conflict may arise between the altruistic principles motivating the act of donation and the profit-making objectives . When donated material emerges from the public management setting and becomes a source of profit, the instrument of informed consent may not adequately protect the dignity of the donors. In the era of medical biotechnology revolution, any use of the donated material must be justified and consistent with the values motivating the act of donation.

KEYWORDS:

• human biological materials
• advanced therapy medicinal products
• tissue donation
• cell donation
• altruism
• informed consent

Notes on contributors

Luciana Riva is Phd in Bioethics and researcher at the Bioethics Unit of Istituto Superiore di Sanità, Roma.

Giorgio Resta is Vice-Director of Law Department and Full Professor of Comparative Private Law at Università Roma.

Alberto Gambino is Pro-Rector Vicar and Full-Professor of Private Law at Università Europea di Roma.

Carlo Petrini is Director of the Bioethics Unit and President of the Ethics Committee of Istituto Superiore di Sanità, Roma.

Correspondence to: Luciana Riva [email protected]