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Über dieses Buch

The multidisciplinary book assesses the legal and economic uncertainties surrounding the collection, storage, provision and economic development of biological samples (tumors, tissues, cells) and associated personal data related to oncology. Public, partly public and private sector actors in the field of cancer care and research hold collections supported by significant public and social funding. Under certain conditions, particularly in the context of networking (sometimes promoted by public authorities), these collections can also represent major economic assets and scientific resources. However, this involves a number of issues and institutional constraints:

legal: the will of the source person; non-pecuniary damage; freedom to establish collections; competence in deciding on their use; legal frameworks for their distribution; desire for return on investment for public institutions, notably in terms of industrial and intellectual property.

economic: cost of establishing and running biological resource centres; destroying resources; emerging markets; profit sharing.

public health policy choices: prioritisation of therapeutic measures over research (fundamental or clinical trials); conservation of resources; promotion of scientific (and not commercial) value of collections.

The establishment, heritage recognition (“patrimonialisation”), development and sharing of these resources thus merit our calling into question present practices and their evolution, as well as the leverage available to public authorities (incentives, legislation, regulation) in a context where norms emerge from professional practice to become widely used in collaborative networks.

Filling a gap in the current literature on law and economics, which pays little heed to these specific considerations, this book explores these considerations to bring to light the economic implications of ethical choices and governance issues in the health sector (structural organisation of local, national and European actors in oncology).

It is intended for researchers in fields such as law, economics and biomedical sciences, as well as for public policymakers.

Inhaltsverzeichnis

Frontmatter

Erratum to: Public Regulation of Tumor Banks

This online version of this book was inadvertently published without a Copyright remark about the French version in the copyright page. This has now been rectified.

Xavier Bioy

Tumor Banks or the Valorization of a Complex Object

Frontmatter

Chapter 1. Is Putting Cancer in Banks a Patrimony To Be Developed?

The samples and collections of tumors circulate, sometimes a little, sometimes a lot, sometimes for “in house” scientific purpose only, sometimes in the perspective of making them available to third parties. What should be their economic model? What are today’s practices? What can be done? What should be done? What legal framework should be used in that respect?These seemingly simple issues, which are first of all to do with public health policies and economic analysis, raise considerable legal problems. They also require consideration from a societal point of view. They mainly imply taking stock of the practices and objectives of research professionals, as well as to become aware of the social representations of these yet little-known objects.

Xavier Bioy

Chapter 2. Biological Samples and Their Sampling Degrees

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.

Thibaut Coussens-Barre

Chapter 3. Personal Data Protection in Tumor Banks

The biological samples collected, registered and stored in biobanks could not be used for medical research without their associated personal data which can result in their direct or indirect identification. Any research on biological samples such as tumors—whose specificity lies in the fact that they were only removed as part of medical care—necessarily implies the collection and use of personal data. The set of French and European statutes does not adequately address the question of personal data patrimony. They merely authorize the use of personal data by the tumor banks and set conditions for this use, such as the consent and confidentiality requirements. These two requirements, which are not clearly defined, show the difficult and unavoidable conciliation between the need to allow the development of research, on one hand, and the need to ensure patients’ protection and maintain their trust in biobanks, on the other hand.

Emilie Debaets

Chapter 4. The Policies of Tumor Biobankers: Main Strategies and an Example of the Policies Adopted by the Nice Hospital Biobank, France

Biobanks are evolving, as is shown by the emergence of what are known as “Next Generation Tumor Biobanks” (NGTB). In addition, some research activities are being dissociated from healthcare (diagnostic, prognostic, targeted therapy, immunotherapy) and from the development of genomic medicine. Many biobanks are taking on new roles, becoming centers of expertise in a wide variety of fields (clinical, pathology, genomics, bio-statistics, bio-informatics, and even mathematics), as well as repositories for the collection and storage of samples.

Paul Hofman

Chapter 5. The Concept of Biological Samples Collection

The main mission of the BRC is to ensure the management of the biological resources and collections: reception, preservation, preparation and disposal requested by a Clinical Research Associate and/or a researcher. According to the type of studies on biological samples: constitution of a new collection involving the human person (categories 1, 2 and 3 of the Jardé Law) or use of requalified research samples not involving the human person (not regulated by the Jardé Law), the BRC guides the “applicant” to the legal department attached to its administrative structure to enforce the new regulatory proceedings.

Anne Brouchet, Sophie Peries

Chapter 6. Does Tumor Bank Regulation Promote the Valorization of Tumor Collections?

Biobanks regulation has gradually developed following scientific and normative needs, which has led to the coexistence of a heterogeneous set of rules. Several regulations are applicable depending on the context of how the following were collected: elements of the human body and associated personal data, their conditions of conservation, and the purpose of their use. Thus, tumor banks must combine the provisions of bioethics law, public health laws with those of the data protection Act, and with that of research involving human individuals. The accumulation of rules can mean hindrance and difficulties for those concerned. The availability of biological samples to researchers, and so their scientific development, can thus be hampered by a too complex legislation which is difficult to access for its recipients. Therefore, the question that arises is the following: do biobank regulations, consisting of scattered legal rules, constitute a brake on the valorization of these activities, and do they promote the development of the biological sample collections?

Anna Pigeon

Chapter 7. Economic Modeling and Valorization of Biobanks

The economic valorization of biobanks is mainly a question of valorizing research. Successful research is dependent on access to high-quality samples, provided by biobanks, and on the degree of involvement of the actors in the sample production chain. However, the provision of samples can be impacted by information asymmetries in the biobank-research team relationship. The economics literature contains numerous studies analyzing the effect of information asymmetries on the economic valorization of inputs in the innovation process. A key issue in this respect is ensuring contracts provide the parties with adequate remuneration for the effort they provide, while maintaining incentives for innovation.

Catherine Bobtcheff, Carole Haritchabalet

Chapter 8. Socializing Tumors: From the Conservation of Tumors in Banks to Their Ontological Variations

Biobanks are thus considered as developing infrastructures calling for a joint political, ethical and legal regulation. They are a focus for action. But how do matters stand when biobanks are a sociological focus of research, released from performative issues, when “the social” is not seen as the equivalent of “society” which causes problems or generates constraints in relation to the access and the use of parts of the human body? A theoretical approach to the social as an attachment process between human and non-human entities raises the question of biobanks being considered as a body of living organisms socialization, meaning a place where human and non-human entities are associated, where the human body is broken up.

Fabien Milanovic

The Issues Related to Tumor Collections Valorization

Frontmatter

Chapter 9. The Valorization of Tumor Collections: Reconciling the Interests of the Different Actors

Tumor banks are at the heart of many expectations, hopes, and objectives, and must consider the often-contradictory interests of the different actors wishing to ensure best use is made of collections of human biological material. These actors include:People who want to know their medical status (patients and their families) but who want to be sure medical practitioners and researchers respect their informed consent when accessing their sample and information stored in tumor banks;People who produce and use medical information (medical practitioners, researchers, professional societies), who question how this information is produced and provided;People who finance research and development, who want optimal use to be made of these resources, or even to make a profit from them;People who supply biological samples and associated data (managers of collections or biological resource centers), who want to maximize the use and development of their resources;People who control biological resources (public control structures, public health decision-makers), for whom assessing the risks associated with using samples is paramount;Civil society, which influences the acceptability of the development of biobanks.

Emmanuelle Rial-Sebbag

Chapter 10. The Development of Tumor Collections: The Interest of the European Union

Biomedical research in the twenty-first century and the challenges it entails could not remain simply national and it became necessary to pool resources and expertise at the level of the European Union (Joly 2017 Gouvernance des tumorothèques: tendances internationales. In Tumor Banks—régulation publique des centres de ressources biologiques en cancérologie (colloque dir. X. Bioy, Toulouse)) to facilitate the flow of information between researchers and institutions through the development of databases, incorporating a large amount of data (big data). This contribution is intended to examine the way in which the policy of the European Union promotes the development of research infrastructures devoted to biobanks, which includes tumor banks, and to assess if the current legal framework in which they operate at European level is adapted to allow the development of tumor collections.

Nathalie De Grove-Valdeyron

The Means for Tumor Collections Valorization

Frontmatter

Chapter 11. Academic Valorization of Biobanks

Collections intended for purely academic purposes are run on a nonprofit basis, whereas commercially managed collections are intended to make a profit for their owners by placing on the market samples private researchers can buy when they do not have their own source of research materials. In recent years, researchers using collections for multicentric projects have been reflecting on how collections can best be used. Calls for applications for European research programs stipulate that consortia conduct their research in accordance with European and international ethical guidelines.

Anne-Marie Duguet, Laurence Mabile, Anne Cambon-Thomsen

Chapter 12. Commercialization Through the Use of Private Law Contracts

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.

Laurent Izac

Chapter 13. The Governance Framework of North American Biobanks: A Rapidly Evolving Policy Patchwork

In recent years, a growing number of biobanks and associated research projects have emerged in North America. This paper intends to map out the governance framework of biobanks in Canada and the United Sates (US). The governance of biobanks can be characterized as a threefold enterprise: legal instruments, such as legislation and case law will apply to many biobank processes and activities; ethics codes and institutional policies provide a source of non-binding governance rules; and finally, biobanks themselves often develop their own governance policies.

Yann Joly, Miriam Pinkesz

Chapter 14. Biobank Expertise and the Research Unit-Biobank Relationship

The present paper models the relationship between a research unit wishing to launch a new project and a biobank capable of supplying the necessary biological resources (biological samples and associated data). Although the project’s aim may be to produce an innovative product or process, such as a new drug or treatment protocol, whether it will be a success is uncertain. Neither the biobank nor the research unit can know a project’s commercial value in advance, but this value is endogenous, that is, it depends on the actions and decisions of the actors involved. Our objective was to ascertain how these actions and decisions affect the project’s value.

Catherine Bobtcheff, Carole Haritchabalet

Chapter 15. Extra-Patrimoniality for the Patient

It seems that the valorization of tumor collections is difficult, but it is necessary to go beyond the obvious because the extra-patrimoniality, which should be defined, is actually only about the patient, leaving out of bounds the protective principles of the Civil Code in relation to all successive stakeholders of these biological samples, which might encourage the lawmakers to extend it. But, even if one remains focused on the patient, what exactly does property law and property value mean? Why is there such a difference in vocabulary? Does property law equal property value? Are only free cessions allowed?

Sophie Paricard

Chapter 16. The Moment of Patrimonialization

The legislative power organizes two types of banks: those preserving essentially for themselves and those ensuring the availability of preserved elements. In both cases, they must be supplied. The first sections focus on the modalities governing how banks or collectors request resources for scientific research and the access conditions to different types of elements and human body products. This “moment of patrimonialization” i.e. the moment when the person from whom elements are derived can no longer claim any right, depends on the process the elements’ extraction, either swabbed or removed, from deceased or living persons. This review shall analyze the rights and duties of banks in respect of the use of these elements after they have been detached and preserved for scientific purposes.

Marie-Xavière Catto

Chapter 17. The Patrimonial Specificities of Public Persons

A public person is not owner as private individuals are. Their assets are public and no other criterion than the public figure of the owner is required, as well as their right to property, which is public—not private as that of Article 544 of the civil code—the exercise of which is immediately assigned to the satisfaction of the legitimate interests of their role. Therefore, specific patrimonial features which, certainly, have such a level of generality that their scope seems limited or their independence uncertain, are no less essential. It is through the prism of this public property right that tumor banks and biobanks will be approached.

Benoît Schmaltz, Pierre Égéa

Chapter 18. Biological Sample Collection in the Era of Genomic Medicine: A New Example of a Public Commons?

The model of the commons appears theoretically relevant for thinking, not so much about health in general—health as an international public good has been the subject of numerous studies—but about the governance of the health tool that biobanks constitute, especially as we enter the era of genomic medicine. Nonetheless, the governance of biobanks, as transformed by genomic medicine, will have to meet some conditions in actual practice to constitute a true commons.

Christine Noiville, Florence Bellivier
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