Ownership of Human Biological Material: To Whom Does the “Ownership” of the Human Body and Its Parts Belong? Who Has the Right to Dispose of It and for What Purpose?

There is a legal uncertainty linked to the validity and sustainability of the transfer of the property in a sample from a donor to a biobank and the legal effect on this of a withdrawal of consent (which is standard wording in a consent form). This extends to any analytical results derived from such a sample in the context of secondary use, not to mention the uses made of data derived from the sample that later become protected under IP laws. The biobank is responsible for the correct conservation and management of such materials and the data connected to them, in the general interests of research, for the protection of the community and in the interests of the donor. The main point for a tissue biobank is the definition of the legal status of the human body and the ownership of the tissue with which it is endowed. The commercial implications associated with these results and the potential profits that may be derived from them raise the need for a clear definition of the ethical–legal position of the biobank as the entity handling the samples. The question of the economic exploitation of the material stored in a biobank is, in fact, still the subject of extensive debate and reflection.