Spanish Regulation of Biobanks

Spanish National Institute of Statistics, Population Figures at 1 July 2014 Migration Statistics, Press Release, December10, 2014, available at <www.ine.es/en/prensa/np884_en.pdf> (last visited November 13, 2015).

Spanish National Institute of Statistics, Contabilidad Nacional Trimestral de España , Press Release, February 26, 2015, available at <http://www.ine.es/prensa/cntr0414.pdf> (last November 13, 2015).

Spanish Constitution, October 31, 1978 as sanctioned December 27, 1978.

Ministry of Health, Social Services and Equality, National Health System – Spain 2012 , 2012, available at <https://www.msssi.gob.es/organizacion/sns/docs/sns2012/SNS012__Ingles.pdf> (last visited November 13, 2015).

Law 14/1986 General Health, April 25, 1986.

Law 16/2003 on Cohesion and Quality in the NHS, May 28, 2003.

Personal communication from Manuel Morente, Coordinator of the Spanish National Hospital-based Biobanks Network Biobanks, to author (January 20, 2014) [hereinafter cited as Morente].

Spanish National Plan for Scientific and Technical Research and Innovation 2013–2016, available at <http://www.idi.mineco.gob.es/stfls/MICINN/Investigacion/FICHEROS/Spanish_RDTI_Plan_2013–2016.pdf> (last visited November 13, 2015).

Order ECC/1051/2013, June 7, 2013, at Article 3.2.

Law 14/2011 on Science, Technology and Innovation, June 1, 2011.

For more information on biobanks with in vitro research purposes see: Law 14/2007 on Biomedical Research, July 3, 2007 and Royal Decree 1716/2011, November 18, 2011 establishing the basic authorization and operation requirements for biobanks for the purpose of biomedical research and for the handling of biological samples of human origin, and regulates the operation and organization of the National Biobank Registry for biomedical research. For more information on biobanks with Transplant or in vivo research purposes see: Royal Decree-Law 9/2014, July 4, 2014 by which the regulations for the quality and security of the donation, collection, evaluation, processing, preservation, storage and distribution of human cells and tissues are established, and the legal norms for the coordination and operation for their use in human beings. For more information on biobanks with Hemodonation purposes see: Royal Decree 1088/2005, September 16, 2005 by which the technical requirements and minimum conditions for hemodonations and for the blood transfusion centers and services. For more information on biobanks in the Forensic framework see: Organic Law 10/2007, October 8, 2007 that regulates the police database on identifiers obtained from DNA. For more information on biobanks for Assisted Reproduction see: Royal Decree 413/1996, March 1, 1996 by which the necessary technical and operational requirements for the authorization and approval of the health centers and services for assisted reproduction. For clinical biobanks (with diagnostic purposes), there is no legislation. As samples in clinical contexts can be considered as part of the clinical record, it should be applied the general provision in Law 41/2002, November 4, 2002 regulating patients autonomy and the clinical information and documentation.

Spanish Ministry of Economy and Competitiveness, Platform and National Registry of Biobanks, available at <http://www.eng.isciii.es/ISCIII/es/contenidos/fd-el-instituto/fd-organizacion/fd-estructura-directiva/fd-subdireccion-general-investigacion-terapia-celular-medicina-regenerativa/fd-centros-unidades/registro-nacional-de-biobancos.shtml> (last visited November 13, 2015).

Nicolás P. , El régimen legal de la utilización de muestras biológicas en proyectos, colecciones y biobancos , paper presented at Los biobancos y su regulación en las Comunidades Autónomas, Hospital Universitario Central de Asturias, Oviedo, Spain, March 5, 2012, available at <http://cei.uniovi.es/biomedicina/jornadas/recursos/biobanco> (last visited November 13, 2015).

These biobanks belong to Hospitals and universities (72), research centers (11), companies (3), hemodonation centers (2), other centers (2) and a national biobank (1). See Morente , supra note 7.

These conditions are described in the documents referring to biosecurity and transport of the National Net of Biobanks: Instituto de Salud Carlos III, Orientaciones de Bioseguridad aplicables a Biobancos , 2012, available at <http://www.redbiobancos.es/Pages%5CDocs%5CDocumento_de_Bioseguridad_en_Biobancos.pdf> (last visited November 13, 2015); Instituto de Salud Carlos III, Transporte de Muestras para Biobancos , 2012, available at <http://www.redbiobancos.es/pages/docs/Documento_Transporte_de_muestras.pdf> (last visited November 13, 2015).

Royal Decree 223/2004 for which clinical trials are regulated with medication, February 6, 2004.

Nicolás P. , “Los derechos del paciente sobre su muestra biológica. Distintas opiniones jurisprudenciales,” Revista derecho y genoma humano no. 19 (2003): 207–228.

Instituto de Salud Carlos III, Respuestas a las preguntas más comunes sobre el real decreto 1716/2011 sobre biobancos, 2012, available at <http://www.isciii.es/ISCIII/es/contenidos/fd-el-instituto/fd-organizacion/fd-estructura-directiva/fd-subdireccion-general-investigacion-terapia-celular-medicina-regenerativa/fd-centros-unidades/Preguntas-y-respuestas-RD-1716-10-10-2012.pdf> (last visited March 17, 2015).

Instituto de Salud Carlos III, Modelo de Consentimiento Informado de la Red Nacional de Biobancos , 2012, available at <http://www.redbiobancos.es/Pages%5CDocs%5CModelo_de_Consentimiento_Informado_de_la_Red_Nacional.pdf> (last visited November 13, 2015).

Farmaindustria, Farmaindustria's Standard Code on Personal Data Protection in Clinical Research and Pharmacovigilance , 2009, available at <http://www.agpd.es/portalwebAGPD/canaldocumentacion/codigos_tipo/common/pdfs_ingles/Farmaindustria_Standard_Code_on_Personal_Data_Protection_EN.pdf> (last visited November 13, 2015). This code does no refer to biological samples nor genetic data. It interesting to underline that it establishes mechanisms and guarantees according to which coded data stored by the promoter are not subject to security measures.

Cámpora R. G. , Presentación del Libro Blanco de la Anatomía Patológica en España 2013 , 2013, available at <http://www.seap.es/libros-blancos> (last visited November 13, 2015).

All the reports of the Spanish Bioethics Committee are available at: Comité de Bioética de España, Documentation and Publications, available at <http://www.comitedebioetica.es/documentacion/index.php?lang=en_US> (last visited November 13, 2015).

Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, October 24, 1995, at Article 2: ‘controller’ shall mean “the natural or legal person, public authority, agency or any other body which alone or jointly with others determines the purposes and means of the processing of personal data; where the purposes and means of processing are determined by national or Community laws or regulations, the controller or the specific criteria for his nomination may be designated by national or Community law; ‘processor’ shall mean “a natural or legal person, public authority, agency or any other body which processes personal data on behalf of the controller.”24. This guide is based on: European Union, Opinion 05/2012 on Cloud Computing , 2012, available at <http://ec.europa.eu/justice/data-protection/article-29/documentation/opinion-recommendation/files/2012/wp196_en.pdf> (last visited November 13, 2015, 2015).

Nys H. Fobelets G. , “The Regulation of Biobanks in Spain,” Revista de Derecho y Genoma Humano 29, no. 1 (2008): 169–188, at 186.

Arias-Diaz J. Martín-Arribas M. C. García del Pozo J. , “Spanish Regulatory Approach for Biobanking,” European Journal of Human Genetics 21, no. 7 (2013): 708–712, at 711.

Liaño F. Torres A. M. , “Biobanks: A New Tool for Clinical Research,” Nefrología 29, no. 3 (2009): 193–195; Doménech García N. Cal Purriños N. , “Biobanks and Their Importance in the Clinical and Scientific Fields Related to Spanish Biomedical Research,” Reumatología Clínica 10, no. 5 (2014): 304–308.

Romeo C. Nicolás P. Romeo S. , “Legal and Social Implications of Creating Banks of Biological Material in Spain,” in Romeo C. M. Simon J. W. , eds., LatinBanks: Study on the Legal and Social Implications of Creating Banks of Biological Materials for Biomedical Research (Bruxelles: Bruylant, 2011): At 311–363; Casado Da Rocha A. Seoane J. A. , “Alternative Consent Models for Biobanks: The New Spanish Law on Biomedical Research,” Bioethics 22, no. 8 (2008): 440–447.

Chalmers D. Nicol D. Nicolás P. , “A Role for Research Ethics Committees in Exchanges of Human Biospecimens through Material Transfer Agreements,” Journal of Bioethical Inquiry 11, no. 3 (2014): 301–306, at 305.