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2018 | OriginalPaper | Chapter

12. Commercialization Through the Use of Private Law Contracts

Author : Laurent Izac

Published in: Public Regulation of Tumor Banks

Publisher: Springer International Publishing

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Abstract

The possibility to organize the commercialization of biobanks using private law contracts may seem doubly surprising. Indeed, each of the two themes included in this proposal— commercialization and private law—seem to go against the first intuition of biobanks to be removed from the temptation of commodification inherent in things of economic value and that, because of their nature and of their particular vocation, they escape private law for the benefit of public law. However, this first intuition is immediately contradicted by the finding that there is already some contractual practice providing a form of marketing of biobanks. Just consider the conventions of making available all or part of certain collections. There are sometimes real cessions for the benefit of third parties that are not necessarily public people.

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previous chapter Academic Valorization of Biobanks

next chapter The Governance Framework of North American Biobanks: A Rapidly Evolving Policy Patchwork

E.g. BBMRI-ERIC: Biobanking and Biomolecular Resources Research Infrastructure—European Research Infrastructure Consortium.

Art. R. 1235-7 to R. 1235-11 of Public Health Code.

At least, in French law, on which we shall focus our comments.

Art. 16-1 of Civil Code.

According to the definition given by the Centre National de Ressources Textuelles et Lexicales.

We are closer here to the objectives set by Article L.111-1 of the code of research:

The national policy of research and technological development aims to:
(1)

increase knowledge;

(2)

share the scientific, technical and industrial culture;

(3)

develop the results of research to the benefit of society [...]

For a list of BRCs affiliated to the Biobank network (with 83 BRCs representing more than 700 research teams), see the following website: http://www.biobanques.eu/fr/annuaire-des-biobanques.

It is also possible and common that a convention binds two public people, in which case, the jurisprudence of the Court of conflicts (TC, 21st March 1983, PSU) assumes that the contract falls under public law. It is however only a mere presumption that the material criterion can reverse.

According to the jurisprudence of the Court of conflicts (TC, 13th October 2014, Axa company), two cumulative conditions are necessary to consider that a clause is beyond the scope of common law: it must necessarily be exercised for general interest purposes and either give “the public person prerogatives or advantages beyond the scope of common law” or impose “to the other party obligations or constraints beyond the scope of common law”.

This statute aims, more specifically, at common things which it defines as the “things that do not belong to anyone and whose usage is common to all”. The change from the category of common thing to that of common asset, therefore, requires its ownership.

Art. L. 1243-3. Three of the Public Health Code al. two aims at “gathering, for scientific purposes, biological samples taken from a group of people identified and selected based on the clinical or biological characteristics of one or more members of the group, as well as derivatives of these. Samples” .

This expression is more comprehensive, but it is not fully satisfactory because of the metonomy effect it may convey (see below).

That exercised by the collection manager.

On the issue of extra-patrimony for the patient, see S. Paricard’s article.

We think of an employment contract under which the person puts their physical and/or intellectual strength at the service of their employer.

We think of a medical contract. Although, since the application of Article l. 1142-1-1 of the Public Health Code, the responsibility of the physician has become legal (to transcend the distinction between civil and administrative liability), and consent to care naturally remains a fundamental principle. It is the expression of will of the patient so that intervention on their body becomes possible. It would be difficult not to see a legal act concerning the patient’s own body.

On the issue of when becoming part of a patrimony occurs, see M.-X. Catto’s article.

The common law of trust is regulated in Articles 2011 and those following of the Civil Code. Given its nature and its particular purpose, the collection called for a special regime of trust which should transcend the opposition between private and public property.

Wear can be defined as the phenomenon of “alteration, deterioration of a material thing, resulting from prolonged use or mechanical or chemical action”, CNRTL.

Scientists estimate that the same cancers of the same organ allow identical studies.

It seems useful to note the fact that this phenomenon does not make the samples part of the category of consumable things. Indeed, a thing can be consumed if the very principle of it being enjoyed lies in its destruction: this is the desired effect. So, fuel is a consumable thing because its use is very precisely to seek its destruction-combustion. For other goods, on the other hand, if an alteration/destruction is likely to occur when using them, it is a sustained effect, which is the case for biological samples.

According to INCA reports:

Nearly 90% of BRCs have made a declaration of use of biological resources for their own research projects.
Sixty percent state an authorization number for the transfer of samples to another agency,
About 20% of BRCs have an authorization number for import and export of organs, tissues and their derivatives and cells from the human body for scientific purposes.

The biobank network—which has no legal personality and is hosted by a service department of INSERM—includes 83 BRCs. That represents more than 700 research teams.

This certification corresponds to standard AFNOR NF S 96-900 “Système de management d’un Centre de ressources biologiques (CRB) et qualité des ressources biologiques d’origine humaine” published in 2008 and/or standard ISO 9001. For more information, see Mr. J.-H. Di Donato’s article.

We find this ambiguity in the terminology used by the European Commission when it comes to “biobanks”: they will refer to “collection” or “storage and distribution centers”. Decision of the Commission implementing no. 2013/701UE (JOUE L 320/63) of November 22nd, 2013 on the Constitution of Research Infrastructure dedicated to biobanking and biomolecular resources consortium for a European research infrastructure (ERIC-BBMRI).

Its conclusion is evoked, if at all, in the authorization process provided for by Art. L. 1244-4 of the Public Health Code. Art. R. 1243-4 6 ° of the same code, which specifies the application procedure, indicates that it will comprise the list: ‘(d) if applicable, [of] manufacturers of medical devices or pharmaceutical companies that will be the beneficiaries of transferred tissues or their derivatives’.

Annexes 3 and 4 suggests that the code of ethics of the Biobank network should be annexed to the convention.

The use of contractors by the industrialist should be subject to a special scrutiny. It would be good practice to clarify whether it is allowed or not. In the latter case, there should be an indication, on the one hand, of how it can be used and, on the other hand, of how the industrialist should supervise and control the work done by the subcontractor.

In accordance with the purpose of the collection.

It is possible that, for tax or financial reasons, the industrialist take part in the convention through one of their subsidiaries, the solvency of which would be disproportionate to their own.

This insurance could be a damage insurance and/or a liability insurance.

Given that intermediate positions will remain possible.

The consortium is considered in doctrine as being the intermediate level between indivision and society. In the absence of a legal definition, it is generally considered as a cooperation agreement, more commonly called a joint venture, concluded between two or more physical and/or moral persons committed to mandate, each with respect to themselves, the distinct outputs to a specific joint operation.

According to jurisprudence, for this transfer of custody to be legally effective, the one who receives the thing should have ways to prevent the damage it is likely to cause. The technical and scientific capacity previously mentioned will also be essential here.

One can think, for example, of serious failure in terms of certain technical rules.

Otherwise, the essential obligation of the BRC would be devoid of significance. Rightly, case law does not admit it.

The Biobank network has already implemented a pricing service grid. However, it has no meaning and credibility unless the corresponding services have a certain level of quality.

Art. L. 442-6 of the Commercial Code.

Chassang, G., Chambon Thomsen, A., & Rial-Sebbag, E. (2016). Ethique et réglementation des biobanques de recherche. Paris: INSERM.

Chenut, C.-H. (2003). Le contrat de consortium. Paris: LGDJ.

Rochfeld, J. (2014). Penser autrement la propriété: la propriété s’oppose-t-elle aux “communs”. Revue internationale de droit économique, 28(3), 351–369.CrossRef

Title: Commercialization Through the Use of Private Law Contracts
Author: Laurent Izac
Publisher: Springer International Publishing
Book: Public Regulation of Tumor Banks
Print ISBN: 978-3-319-90562-4

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

Copyright Year: 2018
DOI: https://doi.org/10.1007/978-3-319-90563-1_12