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Vol 24 No 4 April/May 2019

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Professional Conduct Casebook 3rd ed: Digital Pack

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Public Regulation of Tumor Banks: Establishment, Heritage Status, Development and Sharing of Human Biological Samples

Edited by: Xavier Bioy

ISBN13: 9783319905624
Published: October 2018
Publisher: Springer-Verlag
Country of Publication: Switzerland
Format: Hardback
Price: £109.99

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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.

Medical Law
Part I – Tumor Banks or the Valorisation of a Complex Object:
1. Is Putting Cancer in Banks a Patrimony to be Developed? by Xavier Bioy
2. Biological Samples and Their Sampling Degrees by Thibaut Coussens-Barre
3. The Protection of Personal Data by Emilie Debaets
4. The Policies of Tumour Biobankers: Main Strategies and an Example of the Policies Adopted by the Nice Hospital Biobank, France by Paul Hofman
5. The Concept of Biological Samples Collection by Anne Brouchet and Sophie Peries
6. Does Tumour Bank Regulation Promote the Valorisation of Tumour Collections? by Anna Pigeon
7. Economic Modeling and Valorisation of Biobanks by Catherine Bobtcheff and Carole Haritchabalet
8. Socializing Tumours – From the Conservation of Tumours in Banks to Their Ontological Variations by Fabien Milanovic
Part II – The Issues Related to Tumour Collections Valorisation:
9. The Valorisation of Tumour Collections: Reconciling the Interests of the Different Actors by Emmanuelle Rial-Sebbag
10. The Development of Tumour Collections: The Interest of the European Union by Nathalie De Grove-Valdeyron
Part III – The Means for Tumour Collections Valorisation:
11. Academic Valorisation of Biobanks by Anne-Marie Duguet, Laurence Mabile and Anne Cambon-Thomsen
12. Marketing through the Use of Private Law Contracts by Laurent Izac
13. The Governance Framework of North American Biobanks: A Rapidly Evolving Policy Patchwork by Miriam Pinkesz and Yann Joly
14. Biobank Expertise and the Research Unit-biobank Relationship by Catherine Bobtcheff and Carole Haritchabalet
15. Extra-patrimoniality for the Patient by Sophie Paricard
16. The Moment of Patrimonialization by Marie-Xavière Catto
17. The Patrimonial Specificities of Public Persons by Benoît Schmaltz and Pierre Égéa
18. Biological Sample Collection in the Era of Genomic Medicine: A New Example of a Public Commons? by Christine Noiville and Florence Bellivier.