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Consent, Privacy and Property in the Italian Biobanks Regulation: A Hybrid Model Within EU?

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Ethics, Law and Governance of Biobanking

Part of the book series: The International Library of Ethics, Law and Technology ((ELTE,volume 14))

Abstract

The discussion about genetic information and about the related possibility of storing DNA samples and associated data into an organised database has, in Italy, only recently developed and for sure it did not outline all the core problems and possible questions to be answered yet.

It has to be pinpointed that, even within a general context of co-elaboration, agreement and sharing of the contents and opinions expressed within this text, the first paragraph has to be ascribed to Marta Tomasi (Ph.D. candidate, Department of Legal Sciences, University of Trento), the second one to Simone Penasa (Ph.D., Fellow researcher in Comparative Public Law, Department of Legal Sciences, University of Trento) and the third one to Matteo Macilotti (Ph.D., Fellow researcher in Comparative Private Law, Department of Legal Sciences, University of Trento).

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Notes

  1. 1.

    Consider the great interest arisen by Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990).

  2. 2.

    The Icelandic experience had to face similar matters because of the decision of conceding to a private company, DeCode Genetics, the exclusive use of the data collected in the national population biobank.

  3. 3.

    On the contrary, within the field of criminal law, the Italian Parliament recently approved a law (Statute n. 85, 2009, in the Official Journal of the Italian Republic n. 160, 13 July 2009) which, authorising the ratification of the so called Prüm Convention (Convention between the Kingdom of Belgium, the Federal Republic of Germany, the Kingdom of Spain, the French Republic, the Grand Duchy of Luxembourg, the Kingdom of the Netherlands and the Republic of Austria on the stepping up of cross-border cooperation, particularly in combating terrorism, cross-border crime and illegal migration), instituted a national DNA database in order ease criminals’ identification.

  4. 4.

    Adopted by UNESCO on 16 October 2003.

  5. 5.

    In this document OECD defines itself as a «forum where the governments of 30 democracies work together to address the economic, social and environmental challenges of globalisation». The Organisation «provides a setting where governments can compare policy experiences, seek answers to common problems, identify good practice and work to co-ordinate domestic and international policies».

  6. 6.

    Art. 22 of the Convention refers to parts of a human body removed during an intervention.

  7. 7.

    Also according to the Council of Europe’s website, Italy appears among the countries which signed the Convention, but not among those which completely ratified it (http://www.coe.int/t/dg3/healthbioethic/source/INF(2009)3%20état.%20sign%20ratif%20réserves.doc).

  8. 8.

    Case n.21748/2007, paragraph 7.2.

  9. 9.

    Article 3—Primacy of the human being: «(t)he interests and welfare of the human being participating in research shall prevail over the sole interest of society or science».

  10. 10.

    This Protocol was signed in Strasbourg on 27 November 2008.

  11. 11.

    Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin, adopted on March 15, 2006.

  12. 12.

    Art. 2.1.1. «This recommendation applies to the full range of research activities in the health field involving the removal of biological materials of human origin to be stored for research use».

  13. 13.

    Art. 3.ii. «Non-identifiable biological materials (…) are those biological materials which, alone or in combination with associated data, do not allow, with reasonable efforts, the identification of the persons concerned».

  14. 14.

    These are biological materials which, alone or in combination with associated data, allow the identification of the persons concerned through the use of the code, but users of the biological materials do not have access to the code, which is under the control of a third party (art. 3).

  15. 15.

    In this case identification is possible through the use of a code, which is available to the users of the biological materials (art. 3).

  16. 16.

    Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data, adopted in Strasbourg on 28 January 1981.

  17. 17.

    Directive 2004/23/EC of the European Parliament and of 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, Official Journal of the European Union L 102, 4 April 2004, 48–58.

  18. 18.

    Excluding blood and blood products (other than haematopoietic progenitor cells) and human organs, as well as organs, tissues, or cells of animal origin (point 8 of the preamble).

  19. 19.

    Commission Directive 2006/17/EC of 8 February 2006 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, Official Journal of the European Union L 38, 9 February 2006, 40–52.

  20. 20.

    Point 10 of the preamble.

  21. 21.

    Point 11 of the preamble. The ratio of this limitation is quite clear: strict and specific procedures are set in order to guarantee a good quality of the samples which will be used on human body.

  22. 22.

    Such as biobanks of stemcells or umbilical-cord (blood) (point 7 of the preamble).

  23. 23.

    C-12/09 Commission of the European Communities v. Italian Republic.

  24. 24.

    Point 8 of the preamble and art. 1.

  25. 25.

    The Committee is a consultative body instituted by the Presidency of Council of Ministers with art. 43 of the statutory law n. 142 of 2002.

  26. 26.

    Created by the President of the Council of Ministers on 28 March 1990.

  27. 27.

    Recommendation Rec(2006)4, see Footnote 11.

  28. 28.

    Legislative decree n.196, 30 June 2003, Codice in materia di protezione dei dati personali, in the Official Journal of the Italian Republic n. 174, 29 July 2003.

  29. 29.

    This body, called Garante per la Protezione dei Dati Personali, was created with art. 30 of the statute n. 675 of 1996, in the Official Journal of the Italian Republic n. 5, 8 January 1997.

  30. 30.

    Consider, for example, statutory law n. 40/2004, concerning human assisted reproduction. This law was modified by an intervention of the Constitutional Court (judgment n. 151/2009), which somehow tried to loosen the strictness of some rules and to re-establish the borders of the legislator’s latitude. A restrictive legislative approach will be chosen, as well, with regard to end of life decisions whether the bill about advanced directives, currently under discussion at the Parliament, should be approved.

  31. 31.

    This is the problem of follow up information, which repeatedly proved to be a fundamental element for the fulfilment of the research projects.

  32. 32.

    On these matters see infra.

  33. 33.

    Section 90 (Processing of Genetic Data and Bone Marrow Donors) states that «Processing of genetic data, regardless of the entity processing them, shall be allowed exclusively in the cases provided for in ad hoc authorisations granted by the Garante, after having consulted with the Minister for Health who shall seek, to that end, the opinion of the Higher Health Care Council. The authorisation referred to in paragraph 1 shall also specify the additional items of information that should be contained in the information notice pursuant to Section 13, with particular regard to the purposes sought and the results to be achieved also in connection with the unexpected information that may be made known on account of the processing as well as with the data subject’s right to object to the processing on legitimate grounds».

  34. 34.

    Such as organs for transplant, blood and its products for transfusion, embryos and gametes for reproductive purposes and Haematopoietic stem cells derived from cord blood for therapeutic purposes.

  35. 35.

    It is relevant to stress that the Directive 2004/23/CE on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells does not cover research using human tissues and cells, such as when used for purposes other than application to the human body, e.g. in vitro research or in animal models.

  36. 36.

    The Document on “Genetic Data” of the Data protection Working Party clarifies that this biological group «does not include family members such as one’s spouse or foster children, whereas it also consists of entities outside the family circle—whether in law or factually—such as gamete donors or the woman who, at the time of childbirth, did not recognise her child and requested that her particulars should not be disclosed—this right being supported in certain legal systems». Furthermore, Recommendation R (97) 5 of the Council of Europe defines genetic data as «all data of whatever type concerning the hereditary characteristics of an individual or concerning the pattern of inheritance of such characteristics within a related group of individuals».

  37. 37.

    It is also possible to make reference to the Explanatory Memorandum of Recommendation R (97) 5 of Council of Europe, in which it is specified how «The drafters agreed to accord an intermediate status to members of the data subject’s genetic line so as to distinguish them from third parties in the strict sense of the term and to grant them a hybrid legal protection».

  38. 38.

    Article 29 declares that «The Republic recognises the rights of the family as a natural society founded on matrimony».

  39. 39.

    «The Republic recognises and guarantees the inviolable rights of the person, as an individual and in the social groups where human personality is expressed. The Republic expects that the fundamental duties of political, economic and social solidarity be fulfilled» (art. 2).

  40. 40.

    Authority, Decision 24.5.1999.

  41. 41.

    See the Document on “Raccolta di campioni biologici a scopo di ricerca: consenso informato” (Biological samples collection for research purposes: informed consent), February 26, 2009, p. 8.

  42. 42.

    In the decision n. 188/2000, the Court makes reference to a “reserved competence” of the technical-scientific bodies in determining the technical content of therapeutic activity (in the specific case, the list of tumorous diseases admitted to a free selling of the drugs), stressing at the same time the liability corresponding to these bodies. In the decision n. 282/2002 the Court has declared that a legislative intervention on the merit of therapeutic choices related to their pertinence cannot derive from evaluations based exclusively on the mere political discretion of the legislator, but the legislator must provide for the elaboration of opinions (advice) based on the check of the level of the acquired scientific knowledge and experimental evidence, by means of scientific—national and international—institutions, considering the “crucial relevance” which has to be recognized to the technical-scientific bodies. In any case, according to the Court, the legislative intervention must be the result of this kind of (previous, within legislative process) check.

  43. 43.

    Guidelines on the Electronic Health Record and the Health File, as published in Official Journal of the Italian Republic n. 178, 3 August 2009.

  44. 44.

    Guidelines on Online Examination Records, published in Official Journal of the Italian Republic n. 288, 11 December 2009.

  45. 45.

    There is also a set of “Guidelines for the collection, handling and clinical utilization of Haematopoietic Stem Sells” contained into an Agreement between Italian Government (on behalf of Health Ministry) and the Italian Regions and Autonomous Provinces (2003). The Guidelines provide for “qualitative and operational standards, in coherence with the international ones, related to the structures which carry out the taking of, preservation, processing and transplant of Haematopoietic Stem Cells deriving from homologous or hallogenic donor or from the umbilical cord donation”.

  46. 46.

    It has set up the Italian Cord Blood Network (ITCBN), to which it assigns—among other functions—the function of promoting «donation and preservation of umbilical cord blood and the achievement of a number of blood unities able to satisfy national requirements» (art. 2, paragraph 1, letter d); promoting «studies and researches regarding cord blood procurement, preservation and processing in order to achieve an higher quality and safety level» (letter f); promoting «in cooperation with interested voluntary organizations, projects oriented to present solidarity donation of umbilical cord blood to the population, especially to the mothers-donors» (letter h).

  47. 47.

    The Guidelines provide «qualitative and operational standards, in coherence with the international ones, related to the structures which carry out the taking of, preservation, processing and transplant of Haematopoietic Stem Cells deriving from homologous or hallogenic donor or from the umbilical cord donation».

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Authors and Affiliations

  1. Faculty of Law, University of Trento, Trento, Italy

    Matteo Macilotti, Simone Penasa & Marta Tomasi

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  1. Matteo Macilotti
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  2. Simone Penasa
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  3. Marta Tomasi
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Correspondence to Matteo Macilotti .

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  1. Centre for Biomedicine, European Academy Bolzano, Bolzano, Italy

    Deborah Mascalzoni

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Macilotti, M., Penasa, S., Tomasi, M. (2015). Consent, Privacy and Property in the Italian Biobanks Regulation: A Hybrid Model Within EU?. In: Mascalzoni, D. (eds) Ethics, Law and Governance of Biobanking. The International Library of Ethics, Law and Technology, vol 14. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-9573-9_5

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