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IL SOLE 24 ORE Venerdì, 15 Ottobre 2010 13:07
    IL SOLE 24 ORE - SANITA' - 27 APRILE 2010 Di Umberto Izzo e Matteo Macilotti,  LA NEBULOSA DELLE BIOBANCHE, Privacy proprietà e brevetti i nodi più spinosi - In Italia troppi lacci allo sviluppo         Read more
UNITN Venerdì, 15 Ottobre 2010 13:07
    UNITN n. 117 09.2010 - IL MONDO DELLE BIOBANCHE Le prospettive della medicina personalizzata, i problemi giuridici e le garanzie a tutela dei donatori.  Read more
IL SOLE 24 ORE Venerdì, 22 Ottobre 2010 09:09
       IL SOLE 24 ORE - SANITA' - 19 OTTOBRE 2010 Di Umberto Izzo e Matteo Macilotti,  RISCHIO PARALISI DAL NUOVO CODICE SUI BREVETTI L'ultima mossa del legislatore italiano       Read more
News: "Myriad Genetics Case" Venerdì, 05 Novembre 2010 15:10
  The New Brief as Amicus Curiae for the US Government in support of Neither Party in the "Myriad Genetics Patent" Case: The Twilight of Gene Patenting?  Read more
The Issue: What is Meant by the term 'human embryos' in Article 6 (2) (c) of Directive 98/44/EC? Lunedì, 06 Giugno 2011 14:47
  EU Court of Justice, Case C-34/10, Prof. Dr. Oliver Brüstle v Greenpeace e.V.   The case concerns the interpretation of Directive 98/44/EC on the legal protection of biotechnological inventions. German Supreme Court (Bundesgerichtshof) asked the following questions about the directive on the interpretation of the term "human embryo" and related matters:  What is Meant by the term 'human... Read more
Health Data and Re-identification: The Case SORRELL V. IMS HEALTH INC. Giovedì, 30 Giugno 2011 17:07
 Prescription drug records, which contain information about patients, doctors, and medical treatment, exist because of federal and state regulation in this highly regulated field.  This case is about information from prescription records known as "prescriber-identifiable data." Such  data identifies the doctor or other prescriber, links the doctor to a particular prescription, and reveals... Read more
Myriad Case: The Empire strokes back (?) Venerdì, 11 Novembre 2011 16:37
  The Court of Appeal for the Federal Circuit riversed the decision made by the District Court of New York. The latter invalidated the patent owned by Myriad Genetics and the University of Utah Research Foundation over the genes BRCA1 and BRCA2, on the base of the doctrine of "products of nature": isolated DNAs are not “markedly different” from native DNAs, so such molecules are... Read more
News: Brüstle v Greenpeace Venerdì, 11 Novembre 2011 17:22
In this recent case, the ECJ was asked for a preliminary ruling on the interpretation of Article 6 (2) (c) of Directive 98/44/EC on the legal protection of biotechnological inventions. Adopting a broad definition of embryo, the European Court ruled that: " 1. Any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been... Read more
News from Spain Venerdì, 20 Gennaio 2012 11:16
  Published in BOE (Boletin Oficial del Estado) the "Real Decreto" about biobanks. real_decreto_biobancos.pdf Read more

Biobank Law

Foreign Legislations


Law 14/2007, of 3 July, on Biomedical Research



Human Tissue Act, 2004


Code of Practice - Consent


Code of Practice – The removal, storage and disposal of human organs and tissue


Code of Practice – Import and export of human bodies, body parts and tissue


British Medical Association (BMA). Confidentiality as Part of a Bigger Picture - A Discussion Paper from the BMA [Draft] (London: BMA, 2005)


Human Genetics Commission. Inside Information Balancing Interests in the Use of Personal Genetic Information (London: Human Genetics Commission, 2002)


Medical Research Council (MRC).The Wellcome Trust , Access to Collections of Data and Materials for Health Research (London: MRC, 2006)


UK Biobank. The Wellcome Trust, UK Biobank Ethics and Governance Framework, October 2007


UK Biobank. Access to the UK Biobank resource: Advising on the public interest and the public good (Draft), 17 February 2009 


For other documents, visit, http://www.ukbiobank.ac.uk/ (UK Biobank Site)



Nationaler Ethikrat Opinion, Biobank for research



French Law on Bioethics No 2004-800 of 6 August 2004, (Loi no 2004-800 du août 2004 relative à la bioéthique, Paris 6 août 2004 J.O. no 182 of 7 août 2004 14040)


French Law on Public Health Policy No 2004-806 of 9 August 2004, (Loi no 2004-806 du 9 août 2004 relative à la politique de santé publique)


National Consultative Ethics Committee for Health and Life Sciences (CCNE). Ethical Issues Raised by Collections of Biological Material and Associated Information Data: “Biobanks” , “Biolibraries”, Opinion No 77 Paris, March 20 2003



Biobanks in Medical Care Act, (2002:297), 23 May 2002



Act Relating to Biobanks, No. 12, February 21, 2003



Human Genome Research Law, July 3, 2002



Human Genes Research Act RT I 2000, 104, 685 (December 13, 2000)



International Legislation

Oviedo Convention, Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine



Reccomendation Rec(2006)4, Reccomendation of the Council of Europe on the Biological Materials of Human Origin (Strasbourg - March 15, 2006).

Council of Europe. Steering Committee on Bioethics (CDBI) Draft Explanatory Memorandum to the Draft Recommendation on Research on Biological Materials of Human Origin (Strasbourg - March 15, 2006).




OECD Guidelines on Human Biobanks and Genetic Research Databases, 2009


Guidelines for Patenting Genetic Inventions, 2006



The Human Genome Organisation (HUGO). The HUGO Ethics Committee, Statement on Human Genetic Databases (London, December 2002).



United Nations Educational, Scientific and Cultural Organization (UNESCO). The Universal Declaration on the Human Genome and Human Rights (Paris, 11 November 1997)


United Nations Educational, Scientific and Cultural Organization (UNESCO). International Declaration on Human Genetic Data, UNESCO


United Nations Educational, Scientific and Cultural Organization (UNESCO). Universal Declaration on Bioethics and Human Rights (19 October, 2005)



Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS: Geneva, November 2002)


WMA - World Medical Association

World Medical Association (WMA). Declaration of Helsinki, 164, amended in 2000, clarification notes 2002, 2004.


European Society of Human Genetics - ESHG

Data storage and DNA banking for biomedical research: technical, social and ethical issues


Patenting and licensing in genetic testing: ethical, legal and social issues



EC Legislation

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


Directive 98/44/EC, of the European Parliament and the Council of 6 July 1998 on the legal protection of biotechnological inventions


Directive 2001/83/EC, of the European Parliament and of the Council of 6 November 2001 on the community code relating to medical products for human use


Directive 2004/23/EC, of the European Paliament and the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells



Altri articoli...

  1. Italian Legislation