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2018 | OriginalPaper | Buchkapitel

2. Biological Samples and Their Sampling Degrees

verfasst von : Thibaut Coussens-Barre

Erschienen in: Public Regulation of Tumor Banks

Verlag: Springer International Publishing

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Abstract

Biological samples placed within a research collection and stored into a biobank are only the “final product” of a larger sampling process.

Since his detachment from the human body these elements are subject to an information extraction and a packaging process managed by professionals who contribute to create a useful material for researchers.

All these manipulations contribute to transform the raw element extracted from human body into a biological sample. Considering legal theory, it marks the passage from a thing to a good.

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Vorheriges Kapitel Is Putting Cancer in Banks a Patrimony To Be Developed?

Nächstes Kapitel Personal Data Protection in Tumor Banks

Art. L. 611-10 of the French Intellectual Property Code.

Category introduced by Act No. 94-654 of 29th July 1994 on the donation and use of elements and products of the human body, on medical assistance in procreation and prenatal diagnosis. This act will amend the nomenclature of the Public Health Code by inserting part I, second book on the “donation and use of elements and products of the human body”, Art. L. 1211-1 to L. 1274-3 CSP. The regulations are contained in Art. R. 1211-1 to R. 1261-9 CSP.

Three statutes adopted in July 1994 establish the terms generally used since bioethics laws: (1) Act No. 94-548 of 1st July 1994 on the processing of personal data for research in the field of health and amending Law No. 78-17 of 6th January 1978 on information technology, files and freedoms; (2) Act No. 94-653 of 29th July 1994 on respect for the human body; (3) Law No. 94-654 of 29th July 1994 on the donation and use of elements and products of the human body, on medical assistance for procreation and prenatal diagnosis.

The Civil Code dedicates a chapter on the issue, it is entitled « Du respect du corps humain », while the public Health Code covers the issue in two specific books « Protection des personnes en matière de santé » and « Don et utilisation des éléments et produits du corps humain ».

Since the Civil Code focuses more on the protection of the full body and the person being attached to it, the code of Public health organizes the technical conditions of sampling as well as the modalities for the use and circulation of elements and products of the human body.

Art. 16-1 of the Civil Code.

Art. L. 1211-4 CSP.

Art. L. 1211-5 CSP.

Institut National du Cancer (INCA), Conservation et utilisation des échantillons tumoraux en cancérologie. INCA also published Charte éthique des tumorothèques in 2006.

Council of Europe, recommendation CM/REC (2016) six of the Committee of Ministers to Member States on research using biological material of human origin, adopted on 16th May 2016.

Art. L. 1211-2 CSP. See also Thouvenin (2005), p. 33.

Hence the need for an optimal allocation of biological samples to research, the scientific relevance of which is examined by independent ethic committees, e.g. in France, the committees for the protection of persons.

Art. L. 1243-4 CSP.

Art. R. 125-5 CSP.

Within the meaning of Article 1101 of the Civil Code.

Generally, a public or private health institution, a university institution or a pharmaceutical institution.

Art. 570 of the Civil Code: “If an artisan or any person used a material that did not belong to them to form a thing of a new kind, either that the material may or may not return to its initial form, the one who owned it has the right to claim the thing that has been formed by refunding the estimated labour force price on the date of reimbursement ». Art. 571 C. Civ.: “If, however, the labour force was so important that it went well over the value of the material used, the industry would then be deemed the main part, and the worker would have the right to retain the thing they had worked on, by reimbursing the owner of the price of the material estimated on the date of reimbursement”.

Art. 544 Civil Code.

This principle is reflected in Articles L. 1211-2 and L. 1241-1 of the CSP.

Unless there is an irreversible anonymity of the samples.

Obtaining a new express consent for genetic research and non-objection of the patient for other types of research.

Transition from a therapeutic purpose to a scientific purpose or vice versa.

Art. L. 1123-9, R1123-42 et seq. CSP.

Art. L. 1243-3 and L. 1243-4 CSP.

Art. L. 1123-7 CSP.

Art. R1335-1 et seq. CSP.

Bayer, E. (2003). Les choses humaines. PhD, Toulouse.

Bellivier, F., & Noiville, C. (2006). Contrats et vivant (p. 268). Paris: LGDJ.

Binet, J. R. (16th February 2017). Respect et protection du corps humain – Eléments et produits du corps humain – Thérapies génique et cellulaire : médicaments de thérapie innovante et préparations. – Sang humain, J.-Cl. Civil Code.

Bioy, X. (2010). Vers une politique publique des « biobanques », RDSS (p. 885).

Carbonnier, J. (2000). Droit civil, Les personnes (p. 19). Paris: PUF.

Cornu, G. (1997). Droit civil, Introduction, les personnes, les biens (8th ed., p. 168). Paris: Montchrestien.

Dross, W. (2014). Droit des biens (2nd ed., pp. 19–21) Paris: LGDJ.

Galloux, J.-C. (1989). Réflexion sur la catégorie des choses hors du commerce : l’exemple des éléments et des produits du corps humain en droit français. Les cahiers du Droit, 30(4), 1018.CrossRef

Grzegorczyk, C. (1979). Le concept de bien juridique : l’impossible définition. APD, 24, 259.

Jean, S. (2012). La protection des droits subjectifs par la responsabilité civile. PhD, Toulouse (p. 157).

Loiseau, G. (2000). Typologie des choses hors du commerce. RTD Civ., 48.

Malaurie, P., & Aynes, L. (2015). Les biens (6th ed., p. 62). Paris: LGDJ.

Noiville, C. (1997). Pour une protection des collections scientifiques, D (p. 245).

Prieur, S. (1998). La disposition par l’individu de son corps. Th., Dijon, Les Études Hospitalières (p. 71).

Revet, T. (1991). La force de travail : étude juridique. PhD, Montpellier.

Rial-Sebbag, E. (2008). Genèse d’un cadre réglementaire pour les collections d’échantillons biologiques utilisées en recherche. Exploration d’un modèle de gouvernance. RGDM, 27, 233–271.

Thouvenin, D. (2005). Les banques de tissus et d’organes: les mots pour les dire, les règles pour les organiser. LPA, 35, 33.

Zenati-Castaing, F., & Revet, T. (2006). Manuel de droit des personnes (p. 232). Paris: PUF.

Zenati-Castaing, F., & Revet, T. (2008). Les biens (3rd ed., p. 21). Paris: PUF.

Titel: Biological Samples and Their Sampling Degrees
verfasst von: Thibaut Coussens-Barre
Verlag: Springer International Publishing
Buch: Public Regulation of Tumor Banks
Print ISBN: 978-3-319-90562-4

Electronic ISBN: 978-3-319-90563-1

Copyright-Jahr: 2018
DOI: https://doi.org/10.1007/978-3-319-90563-1_2