Tuesday, October 27, 2009

The Legal Status of the Human Tissues Removed From the Body: An annotated bibliography.
As I was going through this article. I noted that it talks about all the legal details of human tissues as propery. Just about all of the articles and things of that I have found have all been about the legal aspect of owning human tissues. They all have pretty much told me the same thing. This one has talked about the Italian civil code I do believe and even other codes of conduct. It also talks about Italians that have made contributions to this status.





Dott. Matteo Macilotti,
Department of Legal Studies
Trento University
The Legal Status of the Human Tissues Removed From the Body
My reasearch deals with the legal status of human tissues material removed from human
body. The study of the relationship between human body and human tissue materials
detached from the body allows to analyse the relationship among the property rights and
the rights of personality. Historically, when the informational capacity of the human
genome was still unknown, human tissues were considered as an aggregate of molecules.
Therefore the law placed emphasis on the material nature of tissues. This is why even the
scholarship has never doubted that the relationship between the donor and the removed
tissues should be based on ownership rights.
Scientific knowledge has revolutionised this perspective, demonstrating the huge
informational capacity contained within the tissues. Thus, from the physical dimension the
emphasis has now been shifted to the informational dimension. From simple aggregates of
molecules, tissues are now considered as a source of data. Such a “dematerialised” vision
of human tissues makes legal protection of removed tissues essential not only in terms of
property rights, but also in terms of the protection of personality and of the right to privacy.
Once removed from the body, human tissues are to be considered as autonomous and
independent entities, given that researches and interventions led on them do not directly
compromise the health of the human body from which they have been separated. For these
reasons Article 5 of the Italian Civil Code cannot be applied in case of removed tissues,
given that it regulates actions on human body considering its integrity.
The Italian scholarship before the formulation of the Art. 5 agreed on the free nature of
human tissues after their removal, whenever they do not imply a decrease in physical
integrity (i.e. tissues removed during surgical intervention or routine diagnosis)1. Once the
tissues are removed, like other goods, they are property of no one and whoever possesses
them becomes their owner2.
The vexata quaestio was the way for obtaining the property. The so called separation
theory advanced by Carnelutti in the 1930s recognizes the property rights on the removed
1 CARNELUTTI, Problema giuridico della trasfusione del sangue, in Foro it., 1938, IV, 95; BIANCA,
Diritto civile, 1, La norma giuridica. I soggetti, Giuffrè, 1978, 163, DOGLIOTTI, Atti di disposizione sul
proprio corpo e teoria contrattuale, in Rass. dir. civ., 1990; SANTORO PASSARELLI, Dottrine generali del
diritto civile, Jovene, 1964, 52. CRISCUOLI, L’acquisto delle parti staccate del proprio corpo e gli artt. 820-
821 c.c., in Riv. dir. fam., 1985, XIV, 271.
2 TALLACCHINI, Bodyright. Corpo biotecnologico e biodiritto, in Biblioteca della libertà, 1998,
XXXIII, 24; Rizzo, Atti di disposizione del corpo e tecniche legislative, in Rass. dir. civ., 1989, 618, 622.
material to the individual from which it has been taken, according to the jus in se ipsum.
According to this interpretation, when the tissue is removed from the donor, in that very
moment the individual from which the material is taken is considered the owner of the part
removed from the body. This thesis has been approved by the Italian Court during the
1960s3. The Court established that the patient is the owner of the biological materials
removed during surgery.
A second hypothesis identifies parallelisms between the rights in removed tissues and the
rights on ideas4. According to the legislative interpretation of the article 2576 of Italian
Civil Code, individuals should be considered the owner of their own biological tissues in
the same way in which they are the owner of their own ideas. According to this legal
assumption, removed tissues are still property of the patient. Therefore, the patient should
be considered as the owner of human tissues, even if they were removed with the help of a
surgeon.
Another thesis considers removed tissues as “natural fruits”, or fruits that originate directly
from the owner's body, eventually with the help of surgery (articles 820 and 821 of Italian
Civil Code)5.
All the thesis mentioned agree on the fact that biomaterials have to be considered in the
same way as any other material wealth6. Historically, these thesis are the consequences of
previous believes that considered biomaterials as surgeon waste. Therefore, from a legal
standpoint, the focus lied on the material nature of human tissues. This is the reason why
even the most advanced Italian scholarship has never doubted that the relationship between
the donor and the removed tissue should considered as ownership rights.
However, after the development of genetics studies and research technologies, biological
materials begun to be considered as a valuable source of medical and genetic data,
contributing to the progress of medical sciences7. These data contain useful information
about the patient such as health, biological identity, predisposition to specific diseases and
paternity. Human tissues deliver biological identity. The same biological identity remained
also after separation from human body. In fact tissues contain the gene pool of the body
they have been removed from. Therefore, from an informational point of view, the
separation of human tissues from the human body, does not imply the complete autonomy
3 Trib. Milano, 17.4.1961, in Temi rom.,1961, n. 37, 141.
4 SANTORO PASSARELLI, Dottrine generali del diritto civile, Jovene, 1964, 52.
5 CRISCUOLI, L’acquisto delle parti staccate del proprio corpo e gli artt. 820-821 c.c., in Riv. dir.
fam., 1985, XIV, 271.
6 SALARIS, Corpo umano e diritto civile, Giuffrè, 2007, 506.
7 RODOTÀ, La vita e le regole, Tra diritto e non diritto, 2006, 81.
of the biological materials from the original body, but simply the opportunity of its
autonomous circulation.
From a descriptive point of view the double relationship between individuals and tissues
and between individuals and information related to the samples can be considered as a
“belonging relationship”8. The property should be considered as a border aspect of the
more general concept called “belonging”9. In the property relationship, the owner and the
owned object are two separate entities. The highest level of “belonging” exists when there
is a correspondence between owner and owned object. This is also the case of personality
rights which are not distinguished from the individual who owns the rights, but are parts of
his identity.
The law considers personality rights as external objects to one’s identity. But, this is only a
fictio, for applying the legal structure of subjective rights, that is shaped on the property
rights’ structure. This legal structure foresees the non-identity between person and object of
right10.
Biological samples entertain therefore two types of relationships with human body. They
entertain a material relationship, which is based on property rights and an informational
one’s, based on personality rights.
This distinction can be found also at an economical level. Biological sample is a good that
consumes entirely within a certain time. Personal data (related to the tissues), “survive”
even if the relative tissues are consumed. The informed consent of the donor for processing
personal data does not imply any real property right for the researcher. It imply simply a
right to use these data within the limits established from the norms ruling personal data
protection. The consent of the donor doesn’t imply the property right of the donor on
material, but an individual right to protect his own privacy11.
The bi-dimensional nature characterising human tissues, both considered as a molecular
aggregates and source of genetic data, represents the main problem in the definition of the
8 ZATTI, Il corpo e la nebulosa dell’appartenenza, in Nuova Giur. Civ. Comm., 2007, II; GROSSI,
Tradizioni e modelli nella sistemazione post-unitaria della proprietà, in Quaderni fiorentini per la storia del
pensiero giuridico moderno, 1978, nn. 5-6, 265 ss.; BESSONE, Diritto soggettivo e droits de la personnalité,
in Id., Saggi di diritto civile, Giuffrè, 1979, 163.
9 SCOZZAFAVA., I beni e le forma giuridiche di appartenenza, Milano, 1982, 2.
10 GOLD, Body Parts: Property Rights and the Ownership of Human Biological Materials,
Georgetown University Press, 1998, 31; BERSON, The Taking of Human Tissue for Research and Commerce:
A Comparison of U.S. And French Approaches, 10 Wisconsin Inter. L. J., 348 (1992).
11 SUTER, Disentangling Privacy From Property: Toward a Deeper Understanding of Genetic
Privacy, 72 Georg. Wash. L. Rew., 737 (2004); LAURIE-MASON, Consent or Property? Dealing with the Body
and its part in the Shadow of Bristol and Alder Hey, 64 Med. L. Rev., 10 (2001); CALABRESI, Una
introduzione al pensiero giuridico: quattro approcci al problema del regime giuridico delle parti del corpo,
in Riv. crit. dir. priv., 1991, 755
relationships between individuals and removed tissues. It is thus essential to establish if
these two dimensions can be ruled by the same legal rules or not.
The choice of a separate legislation for the bi-dimensionality of human tissues depends on
the possibility that these two dimensions can circulate separately. If that result impossible,
it would be better to identify a common regulation able to protect both the dimensions. In
this case the material dimension would prevail on the informational one. In fact the
regulations on the informational field are much more restrictive, given the importance of
ensuring the safe processing of personal data in order to protect the donor’s privacy.
From the material point of view in fact, the researches on biomaterials do not jeopardise
patient’s health. The impossibility of treating the two dimensions separately implies that
the one subjected to a more restrictive legislation absorbs the other12. Therefore the
informational dimension absorbs the material one. The biological sample becomes a
physical support containing data. This “de-materialization” makes legal personality
protection essential in terms of rights to privacy and self-determination. The legislation
moves its focus from property rights to personality rights.
An example is represented by the recent Authorization of the Italian Privacy Authority on
the use of genetic data. According to this latter, human tissues have to be destroyed
whenever the consent of the donor concerning data processing for medical research is
withdrawn. The destruction of the data is ruled by an authority protecting personality
rights. It bear out the absorption of the material dimensions within the personality rights
protection system. The law system ruling the individual-biological sample is based on the
strong connection of these two dimensions, but it would be restrictive to consider this
inseparability within the mere personality rights protection system. In fact it would mean to
associate the material dimension to a law discipline that rules the informational dimension
and therefore consider tissues as mere informational entities which work as physical
supports.
12 TALLACHINI, Bodyright. Corpo biotecnologico e biodiritto, in Biblioteca della libertà, XXXIII,
1998, 24.
ANDREWS L.B., NELKIN D, Body Bazaar: The Market of Human Tissue in The
Biotechnology Age, New York, 2001
ANDREWS L, NELKIN D., Il mercato del corpo, Il commercio dei tessuti umani nell’era
biotecnologia, Milano, 2002
ANDREWS L., Two Perspectives: Rights of Donors: Who Owns Your Body? A Patient's
Perspective on Washington University v. Catalona, 34 J.L. Med. & Ethics 398 (2006)
CALABRESI G, Una introduzione la pensiero giuridico: quattro approcci al problema del
regime giuridico delle parti del corpo, in Riv. crit. dir. priv., 1991, 755
CARNELUTTI F., Il problema giuridico della trasfusione del sangue, in Foro it.,IV, p. 89,
1938
CRISCUOLI G., L'acquisto delle parti staccate del proprio corpo e gli art. 820-821 c.c., in
Riv. dir. fam., XIV, 1985, 271
D’ADDINO SERRAVALLE , Atti di disposizione del corpo e tutela della persona umana,
Napoli, 1983
D’ARRIGO, Il contratto e il corpo: meritevolezza e liceità degli atti di disposizione
dell’integrità fisica, in Familia, 2005, n. 4, 777
DE CUPIS A., Teoria generale, diritto alla vita e all’integrità fisica, diritto sulle parti
staccate dal corpo e sul cadavere, diritto alla libertà, diritto all’onore e alla riservatezza,
Milano, 1959
DOGLIOTTI M., Atti di disposizione sul proprio corpo e teoria contrattuale, in Rass. dir.
civ., 1990, 291
EISEMBERG, Proprietary Rights and Norms of Science in Biotechnology Research, in Yale
L.J., 1987, 97, 181
FERRANDO G., Diritto e scienze della vita. Cellule e tessuti nelle recenti direttive europee,
in Familia, 2005, 1157
GALASSO A., Biotecnologie e atti di disposizione del proprio corpo, in Familia, 2001, 933
GAMBARO A., La proprietà. Beni, proprietà, comunione, in Trattato di diritto privato, (a
cura di) IUDICA-ZATTI, Milano, 1990, 41
GOLD R.E., Body Parts: Property Rights and the Ownership of Human Biological
Materials, Georgetown University Press, 1998
GOTTLIEB K., Human Biological Samples and the Laws of Property: The Trust as a Model
for Biological Repositories, in WEIR R.F., Stored Tissue Samples: Ethical, Legal and
Public Policy Implications, University of Iowa Press, 1998
GREENFIELD D.L., Greenberg v. Miami Children’s Hospital: Unjust Enrichment and the
Patenting of Human Genetic Material, 15 Annals of Health Law, 213 (2006)
GROSSI P., Tradizioni e modelli nella sistemazione post-unitaria della proprietà, in
Quaderni fiorentini per la storia del pensiero giuridico moderno, nn. 5/6, Tomo I, 1978,
265
HARRISON H., Neither Moore nor the Market: Alternative Models for Compensating
Contributors of Human Tissue, 28 Am. J. L. and Med. 77 (2002)
HARDCASTLE R., Law and the Humam Body, Hart publishing, 2007, 110
HARDIMAN R., Toward the Right of Commerciability: Recognizing Property Rights in the
Commercial Value of Human Tissue, 34 UCLA L. Rev. 209 (1986)
HELLER M., EISENBERG R., Proprietary Rights and the Norm of Science in Biotechnology
Research, 97 Yale L.J., 177 (1987)
LAURIE G.T., MASON J.K, Consent or Property? Dealing with the Body and its part in the
Shadow of Bristol and Alder Hey, 64 Med. L. Rev., 10 (2001)
MACILOTTI M., Proprietà, informazione ed interessi nella disciplina delle biobanche a fini
di ricerca, in Nuova giur. civ., 2008, 222
MAGNUS D., CAPLAN L.A., MCGEE G., Who Owns Life?, New York, 2002
PAGANELLI M., Alla volta di Frankestein: biotecnologie e proprietà di parti del corpo, in
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PIRIA C., Gli interessi scientifici e patrimoniali su parti staccate dal corpo oggetto di
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RODOTÀ S., La vita e le regole. Tra diritto e non diritto, Milano, 2006
SCOZZAFAVA O.T., I beni e le forme giuridiche di appartenenza, Milano, 1982
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XXXIII, 1998, 24
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