Human Tissues in the “Public Space”: Beyond the Property/Privacy Dichotomy
- 832 Downloads
During the past 20 years, human biological materials (HBMs) have become increasingly important for research as well as for therapeutic uses and related commercial exploitation. The scientific and regulatory conditions for their procurement, testing, processing, preservation, storage, and distribution have been reflected upon widely and developed in both the civil law and the common law domains.
In the normative puzzle taking place around the biobanking of HBMs and information, the basic legal perspectives underlying most normative analyses remain anchored to the concepts of autonomy—also conceived of as privacy—and property. The former has been primarily developed in Europe, the latter in the US. Both are showing some failures, while the normative picture as a whole appears inadequate.
This contribution explores the main existing legal frameworks for biological materials, both in the US and EU contexts, and the potential for reconciling individual and collective dimensions in biobanking through a participatory approach.
The legal fate of bodily materials is somewhat similar to that of the environment. In both instances, the notions of subject of rights (the rights holder) and of object of property (the object held) have failed to fully represent the potential for collective sharing. And in both cases, the procedural participatory turn has allowed a more adequate legal imagination to address different needs and goals.
KeywordsEuropean Union Biological Material Bodily Material Advanced Therapy Canavan Disease
The present work was funded by the Progetto Sarroch Ambiente e Salute, PI Prof. Annibale Biggeri (Università di Firenze) and sponsored by the Fondazione Bioteca Sarroch.
- Boyle J (1996) Shamans, software and spleens: law and the construction of the information society. Harvard University Press, CambridgeGoogle Scholar
- Caulfield T (2007) Biobanks and blanket consent: the proper place of the public good and public perception rationales. Kings Law J 18:209–226Google Scholar
- CDBI, Steering Committee on Bioethics (2005) Draft explanatory memorandum to the draft recommendation on research on biological materials of human origin Strasbourg, 12 December 2005 Restricted [bioethics/comités>s/plénier CDBI (2005)5REV2 doc de travail/2005/CDBI(2005)5e draft EM GT2biomatREV2 FINAL]Google Scholar
- COE (Council of Europe) (2006) Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin. Adopted by the Committee of Ministers on 15 March 2006 at the 958th meeting of the Ministers' DeputiesGoogle Scholar
- DG Enterprise Consultation (April 2004) Proposal for a harmonised regulatory framework on human tissue engineered products. http://ec.europa.eu/health/files/…/consultation_paper-2008-07-22_en.pdf. Accessed Jul 2012Google Scholar
- Edelman B, Hermitte MA (1988) L’homme, la nature et le droit. Christian Bourgois, ParisGoogle Scholar
- EGE, European Group on Ethics in Science and New Technologies to the European Commission (21 July 1998) Opinion 11 ethical aspects of human tissue bankingGoogle Scholar
- European Data Protection Supervisor (15 August 2009) Opinion of the European data protection supervisor on the proposal for a directive of the European parliament and of the council on standards of quality and safety of human organs intended for transplantation (2009/C 192/02). Off J Eur UnionGoogle Scholar
- Greely HT (1999) Breaking the stalemate: a prospective regulatory framework for unforeseen research uses of human tissue samples and health information. Wake Forest Law Rev 34:737–766Google Scholar
- Harrison CH (2002) Neither Moore nor the market: alternative models for compensating contributors of human tissue. Am J Law Med 28:77–105Google Scholar
- Honoré AM (1962) Gaius. A biography. Clarendon Press, OxfordGoogle Scholar
- ICH, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Harmonised Tripartite Guideline (November 2007) Definitions for genomic biomarkers, pharmacogenomics, genomic data and sample coding categories, E15, Current step 4 versionGoogle Scholar
- Jasanoff S (2010) Taking life: private rights in public nature. In: Sunder Rajan K (ed) Lively capital. Duke University Press, DurhamGoogle Scholar
- Jasanoff S (ed) (2011) Reframing rights: bio-constitutionalism in the genetic age. MIT, CambridgeGoogle Scholar
- Karlsen JR (2011) Platypus politics: normative figments of post genomic research biobanking. Doctoral Dissertation, OsloGoogle Scholar
- Lowrance WW (November 2002) Learning from experience: privacy and the secondary use of data in health research. The Nuffield Trust, London. http://www.nuffieldtrust.org.uk/publications/learning-experience-privacy-and-secondary-use-data-health-research. Accessed Jul 2012
- MRC, Medical Research Council, The Wellcome Trust (2006) Access to collections of data and materials for health research. LondonGoogle Scholar
- NBAC, National Bioethics Advisory Committee (1999) Research involving human biological materials: ethical issues and policy guidance, report and recommendations. Rockville. http://bioethics.georgetown.edu/nbac/pubs.html. Accessed Jul 2012Google Scholar
- OHRP, Office for Human Research Protections (16 October 2008) Guidance on research involving coded private information or biological specimens. http://www.hhs.gov/ohrp/policy/cdebiol.html. Accessed Jul 2012Google Scholar
- OTA, Office of Technology Assessment (March 1987) New developments in biotechnology: ownership of human tissues and cells, Special report, OTA-BA-337. US Government Printing Office, Washington, DCGoogle Scholar
- Passmore J (1974) Man’s responsibility for nature. Duckworth, LondonGoogle Scholar
- Rèmond-Gouilloud M (1989) Du droit de détruire. Essai sur le droit de l’environnement. PUF, ParisGoogle Scholar
- Resnik DB, Kennedy CE (2010) Balancing scientific and community interests in community-based participatory research. Account Res 17(4):198–210Google Scholar
- Stone CD (1972) Should trees have standings? Towards legal rights or natural objects. Southern Calif Law Rev 45:450–487Google Scholar
- US Supreme Court, Office of the Clerk, Washington DC 20543-0001 (20 August 2007) http://prostatecure.wustl.edu/pdf/SupremeCourtLetter.pdf. Accessed Jul 2012Google Scholar
- Tallacchini M (2005) Rhetoric of anonymity and property rights in human biological materials (HBMs). Law Hum Genome Rev (January–June):153–175Google Scholar
- UNESCO (2008) Report of the International Bioethics Committee of UNESCO on Consent Social and Human Sciences Sector Division of Ethics of Science and Technology, Bioethics Section SHS/EST/CIB08-09/2008/1Google Scholar
- Wright Clayton E (2005) Informed consent and biobanks. J Law Med Ethics 33(1):5–21Google Scholar
- Wynne B et al (January 2007) Taking European knowledge society seriously. DG Research Science, Economy and Society, BrusselsGoogle Scholar