Regulation of Biobanks in France

For more information, see European Union, “The History of the European Union,” available at <http://europa.eu/abouteu/eu-history/index_en.htm> (last visited October 21, 2015).

Sutton M. , ed., France and the Construction of Europe, 1944–2007: The Geopolitical Imperative (Oxford: Berghahn Books, 2007): At xiv.

From the following website: “France,” available at <http://www.france.fr/en/institutions-and-values/france.html> (last visited October 21, 2015).

About-France , “The French Health Care System,” available at <http://about-france.com/health-care.htm> (last visited October 21, 2015).

Ameli , “L'assurance maladie en ligne,” available at <http://www.ameli.fr/l-assurance-maladie/connaitre-l-assurancemaladie/getting-informed-about-health-insurance/index.php> (last visited October 21, 2015).

Rial-Sebbag E. Duguet A.-M. Cambon-Thomsen A. , “From Medical Biobanks to Research Tools: Re-Use of Samples. Governance and Human Rights,” in Dierickx K. Borry P. , eds., New Challenges for Biobanks: Ethics, Law and Governance (Mortsel: Intersentia nv, 2009): At 87–94.

Rial-Sebbag E. Cambon-Thomsen A. , “The Emergence of Biobanks in the Legal Landscape: Towards a New Model of Governance,” Journal of Law and Society 39, no. 1 (2012): 113–130.

Rial-Sebbag E. , “Genèse d'un cadre règlementaire pour les collections d'échantillons biologiques humains utilisées en recherche,” Revue Générale de droit médical , no. 27 (2008): 233–271; Rial-Sebbag E. , “Implications juridiques des nouvelles formes de gouvernance en biotechnologies: L'exemple des biobanques utilisées en recherche,” Doctoral Thesis, Toulouse University, available at <http://thesesups.ups-tlse.fr/663/1/Rial-Sebbag_Emmanuelle.pdf> (last visited October 21, 2015).

National Consultative Ethics Committee for Health and Life Sciences, Opinion n°77 Ethical Issues Raised by Collections of Biological Material and Associated Information Data: ‘Biobanks’, ‘biolibraries’,” 2003, available at <http://www.ccneethique.fr/sites/default/files/publications/avis077en.pdf> (last visited October 21, 2015).

Biobanques , “L'infrastructure BIOBANQUES,” available at <http://www.biobanques.eu/> (last visited October 21, 2015).

Directed by Georges Dagher, Ph.D., Inserm.

The other working groups of the Biobank infrastructure are the following: Training and dissemination; quality sample; quality insurance; biological safety; ethics and regulation; methodological tools and informatics; and public-private partnerships.

The quality insurance common service and the ethics/regulation common service.

The legal status of the “Biobanques” infrastructure is not fixed, it is currently a service Unit attached to Inserm.

Rial-Sebbag E. Cambon-Thomsen A. , “Governing Biobanks through an Infrastructure: ELSI Challenges,” in Mascalzoni D. , ed., Ethics, Law and Governance of Research Biobanks: National, European and International Profiles (Dordrecht: Springer Science, 2015).

Yuille M. van Ommen G. J. Bréchot C. , “Biobanking for Europe,” Brief Bioinform 9, no. 1 (2008): 14–24.

European Commission, “ESFRI,” available at <http://ec.europa.eu/research/infrastructures/index_en.cfm?pg=esfri> (last visited October 21, 2015).

BBMRI-ERIC, “Welcome to BBMRI-ERIC,” available at <http://bbmri-eric.eu/> (last visited October 21, 2015).

European Directives 2004/23/EC, 2006/17/EC and 2006/86/EC cover exchanges of biological materials but they do not cover exchange for research: Directive 2004/23/EC on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells, March 31, 2004; Directive 2006/17/EC on Implementing Directive 2004/23/EC of the European Parliament and of the Council as Regards Certain Technical Requirements for the Donation, Procurement and Testing of Human Tissues and Cells, February 8, 2006; Directive 2006/86/EC on Implementing Directive 2004/23/EC of the European Parliament and of the Council as Regards Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements for the Coding, Processing, Preservation, Storage and Distribution of Human Tissues and Cells, October 24, 2006; see Gottweis H. Kaye J. Bignami F. , Biobanks for Europe: A Challenge for Governance, Report of the Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research (Luxembourg: Publications Office of the European Union, 2012).

Council Regulation (EU) No 1261/2013 amending Regulation (EC) No 723/2009 concerning the Community legal framework for a European Research Infrastructures Consortium (ERIC), December 2, 2013.

Deschênes M. , “Les défis de la recherche en génétique dans l'environnement complexe de la collaboration internationale,” in Hervé C. Knoppers B. M. Molinari P. A. , eds., Systèmes de santé et circulation de l'information. Encadrement éthique et juridique (Pairs: Dalloz, 2007): 68–77.

Mitjavile M.-H. , “Législation, informatique et libertés, et recherche médicale,” Médecine et Droit 2011, no. 106 (2011): 37–40.

Act N°78–17 Amended by the act of 6 August 2004 realating to the protection of individuals with regard to the processing of personal data (last update: Ordinance No.2011–2012 dated 24/08/2011 - Law No.2014–334 dated 17/03/2014).

Decision no. 2012–652 DC Identity Protection Act, march 22, 2012, at §8.

Article 40 of the Data Protection Act.

CNIL, Role and Responsibilities, available at <http://www.cnil.fr/english/the-cnil/role-and-responsabilities/> (last visited March 31, 2015).

Pigeon A. Cambon-Thomsen A. Rial-Sebbag E. , Droit des personnes dans la recherche en génétique humaine at Ateliers de droit médical, Ecole européenne d'été du droit de la santé et éthique biomédicale, Toulouse, France, 2012.

Decree No 2005–1309 enacted for the application of Act No 78–17 of January 6, 1978 on Data Processing, Files and Individual Liberties, October 20, 2005, at Article 20.

CNIL, Méthodologie de référence MR-001, Pour les traitements de données personnelles opérés dans le cadre des recherches biomédicales , 2010, available at <http://www.cnil.fr/fileadmin/documents/declarer/mode_d-emploi/sante/MR-001.pdf> (last visited October 21, 2015).

European Medicines Agency, ICH Topic E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories , 2007, available at <http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002880.pdf> (last visited October 21, 2015).

Homer N. Szelinger S. Redman M. , “Resolving Individuals Contributing Trace amounts of DNA to Highly Complex Mixtures Using High-Density SNP Genotyping Microarrays,” PLoS Genetics, 4, no. 8 (2008): 1–9.

Data Protection Working Party, Opinion 05/2014 on Anonymisation Techniques , at Article 29, 2014, available at <http://www.cnpd.public.lu/fr/publications/groupe-art29/wp216_en.pdf> (last visited October 21, 2015).

Directive 95/46/EC on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data, October 24, 1995.

CNIL, Guide la sécurité des données personnelles , 2010, at 44, available at <http://www.cnil.fr/fileadmin/documents/Guides_pratiques/Guide_securite-VD.pdf> (last visited October 21, 2015).

Article 55 of the Data Protection Act.

Noiville C. Labrusse-Riou C. Hermitte M.-A. , “Les limitations légales de la recherche génétique et de la commercialisation de ses résultats: Le droit français,” Revue International de Droit Comparé 58, no. 2 (2006): 275–318.

Article 8 of the Data Protection Act.

Leroyer A.-M. , “Recherches sur la personne humaine – Autorisation – Protection – Examen caractéristiques génétiques,” RTD civ. (2012): 384; Thouvenin D. , “La loi du 05 mars 2012: Des recherches pratiquées sur la personne aux recherches avec la personne,” RDSS (2012): 787.