Abstract
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.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
Council of Europe (1997). Explanatory Report to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, paragraph 133.
- 2.
The originating case in this area was decided in 1990 in Moore v. Regents of University of California, 51 Cal. 3d 120; 271 Cal. Rptr 146; 793 P.2d 479 (‘Moore’). The patient sued the institution after discovering that his cells had been used for research that resulted in economic gain without his knowledge or consent. The Supreme Court of California found that the patient did not have property rights to his excised tissue but could sue for breach of fiduciary duty due to the lack of informed consent. In this case, a distinction was drawn between property rights and the dignity and privacy interests that are based on informed consent principles. Moore later negotiated and came to a settlement agreement with UCLA that covered his legal fees on the basis that he had not been informed nor had he agreed to the research. In 1991, the U.S. Supreme Court also rejected Moore’s claim regarding the profit issues, stating that a hospital patient does not own rights to excised tissue, even if they are valuable through commercialisation.
- 3.
EUROBIOBANK (Network of DNA, Cell and Tissue Banks for Rare Diseases). Funded by the European Union V Framework Research (QLRI-CT-2002-02769)/REPIER (Rare Diseases Epidemiological Research Network) Network funded by the Instituto de Salud Carlos III. File N.o G03/123., Outstanding legal and ethical issues on biobanks an overview on the regulations of member states of the eurobiobank project. https://www.leukemia-net.org/kompetenznetz-leukaemie/content/studieninfrastruktur/themen/biobanken/e11377/infoboxContent11379/Eurobiobank_Uranga_etal_2006_ethical_legal_issues.pdf.
- 4.
Wellcome Trust, Medical Research Council and Department of Health UK. UK Biobank, Ethics and Governance Framework, Version 3.0; October 2007.
- 5.
The reference provisions are represented by the UNESCO Declaration (1997), which states that the human genome is a heritage of humanity and of the family; the Oviedo Bioethics Convention (1997), which, protecting human dignity, establishes that the body and its parts, as such, must not be a source of profit; it should nevertheless be noted that the collected material can be stored or used for different purposes as long as the donor has given informed consent; and finally, the Directive of the European Parliament and of the Council on the legal protection of biotechnological inventions (98/44 / EC), implemented in Italy with the decree-law of 10 January 2006, n. 3, converted, with modifications, by law 22 February 2006, n. 78, which specifies the limits of the patenting of biological material.
- 6.
Court of Justice, judg. 19 December 2013, Innoweb, C-202/12, EU:C:2013:850, paragraph 22, interpreting the protection by Article 7 on the ground that ‘the maker shows that there has been qualitatively and/or quantitatively a substantial investment in the obtaining, verification or presentation of the database contents’.
- 7.
See, for example, Court of Justice, judg. 3 June 2021, C-762/19, SIA ‘CV-Online Latvia’ v SIA ‘Melons’, ECLI:EU:C:2021:434, paragraph 25; Id., judg. 9 November 2004, The British Horseracing Board and Others, C-203/02, EU:C:2004:695, paragraph 31; and Fixtures Marketing, C-338/02, EU:C:2004:696, paragraph 24.
References
Björkman B, Hansson SO (2006) Bodily rights and property rights. J Med Ethics 32(4):209–214. https://doi.org/10.1136/jme.2004.011270
Lobato de Faria P (2009) Ownership rights in research biobanks: do we need a new kind of ‘biological property’? In: Solbakk J, Holm S, Hofmann B (eds) The ethics of research biobanking. Springer, pp 263–276. https://doi.org/10.1007/978-0-387-93872-1_18
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2023 The Author(s), under exclusive license to Springer Nature Switzerland AG
About this chapter
Cite this chapter
Cippitani, R., Colcelli, V. (2023). Ownership of Human Biological Material. In: Colcelli, V., Cippitani, R., Brochhausen-Delius, C., Arnold, R. (eds) GDPR Requirements for Biobanking Activities Across Europe. Springer, Cham. https://doi.org/10.1007/978-3-031-42944-6_31
Download citation
DOI: https://doi.org/10.1007/978-3-031-42944-6_31
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-031-42943-9
Online ISBN: 978-3-031-42944-6
eBook Packages: Law and CriminologyLaw and Criminology (R0)