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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




Law has often to deal with technologies, i.e. with human activities which, employing the attainments of science, bring into existence new media, tools, devices, systems which  improve the quality of life of human beings.


Some examples:

-  law and exploitation of natural resources (energies): energies can be exploited thanks to technologies. The law regulates the production, processing, distribution of energies and natural resources;


-  law and food: the food chain requires the regulation of technologies related to food in order to guarantee, for example, high quality standards;


-  law and biology: in order to provide a legal framework for medically assisted procreation or for cloning we have to deal with the technologies which allow to obtain gametes, stem cells, crossbreds, chimeras;


-  law and medicine: some choices related to the end-of-life issues which are legally significant are dependant on medical notions such as that of brain death. The same notion of therapeutic tenacity must be measured against the available technologies


- law and information technologies: IT has made available tools such as e-documents and e-signatures. The law must cope with these technologies to regulate them or to make them legally available.


The relation between law and technology has several implications. Let’s focus on three of them.




On the one hand law is used for the regulation of technology; on the other law employs technologies to pursue its own goals.


a)     Technology may change the contents of protected legal interests (as it is the case of the right to privacy, which has been transformed by the rise of IT from the right to be let alone to the right of controlling the information pertaining to the individual);


b)    the emergence of new technologies can transform well-established scenarios. For example the so called technology convergence in telecommunications swiped away the features which framed telecommunications as a natural monopoly, opening the market to a potential infinite number of operators, enhancing the free competition within of the sector. This is also true for the vanishing distinction between article 15 and article 21 of the Italian Constitution. Traditionally the former is enforced whenever, for example, the freedom and secrecy of personal correspondence is at play. The latter protects freedom of expression toward a public audience. Which of the two constitutional provisions must be applied for the regulation of phenomena such as pay-tv, chat lines, mailing lists and newsgroups?


c)     Law can employ new technologies to pursue goals which were pursued by other technologies in the past: this is the case of the e-document, the e-signature, the payment of obligations through e-money, the conclusion of contracts through Internet, and so on. In all these examples, new rules set the modalities of employment of digital technologies in order to attain this or that goal which was reached through other technologies in the past;


d)    the rules arising from technologies are shaped by the features characterizing such technologies: for example, one thing is to have rules concerning the matter (atoms), another is to have rules concerning the bits. In some cases this implies the need to re-frame concepts which traditionally refer to material things (such as ownership and possession) or to draw on new concepts (such as the ideas of title and legitimization in the case of dematerialized financial instruments);


e)     technologies create new commodities: this was true in the past for the new value prompted by the invention of printing, from which after a lengthy process the new right of copyright emerged. In more recent years this is happening with regard to data banks (of human tissues for example, but several other examples may be offered). The law is continuously confronted with the need of regulating new commodities which were unknown in the past;


f)     the change in technologies influences also the source and the structure of the rules. Sometimes legal systems prefer to regulate given phenomena by making recourse to international instruments or to regulatory patterns which are not imposed from outside (for example codes of conduct);


g)  technology sometimes may itself become the rule because: i) it imposes the operational rules (for example: the regulation of the digital signature); ii) it incorporates the rule (see art. 3 of the Italian Data protection code; see also Commission Recommendation of 12 May 2009 on the implementation of privacy and data protection principles in applications supported by radio-frequency identification; iii) it guarantees the enforcement (for example: Digital Rights Management);


h)    the norms which regulate the employment of new technologies for establishing  documentary evidence are characterized by high technological contents, as they are expressed by individuals who have specific competences.