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Pharmacogenetics and Fundamental Rights

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Biotech Innovations and Fundamental Rights

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Abstract

The essay focuses on the developing juridical debate on pharmacogenetics, and on the patent-eligibility of purified human genes. In particular, it is focused on the “common heritage argument” according to which genetic human heritage is a common good that cannot be subject to intellectual property rules. First of all the most important theories on genetic heritage as common good are illustrated, then the relationship between patents and access to drugs is explained and finally the advantages (or disadvantages) of patient-tailored medicines are investigated. In conclusion the principles of the Charter of fundamental rights of the European Union connected to these issues are pointed out.

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Notes

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  2. 2.

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    S. Rodotà, New Technologies and Human Rights Facts, interpretations, perspectives. A report for a Fundamental Rights Agency’s discussion (Feb. 10, 2010). See; http://www.europeanrights.eu/index.php?funzione=Samp;op=5amp;id=389 (last visited April 21th 2011).

  5. 5.

    B.M. Knoppers, Human Dignity and Genetic Heritage. Study Paper prepared for the Law Reform Commission of Canada in the Protection of Life Series. Ottawa; Law Reform Commission of Canada, 1991, 23 (1991).

  6. 6.

    B.M. Knoppers, Le Génome humain; le patrimoine commun de l’humanité?, ´ Edition Fides, 14 (1999).

  7. 7.

    Comitato nazionale di Bioetica, Convenzione per la protezione dei diritti dell’uomo e della biomedicina e su Bozza preliminare di Dichiarazione universale sui diritti umani e sul genoma umano (UNESCO), Roma, 83 (1997).

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    E.D. Zard, Patentability of Human Genetic Information; Exploring Ethical Dilemmas within the Patent Office and Biotechnology’s Clash with the Public Good, 6 U. St. Thomas L.J. 486, 511 (2009).

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    E. D. Zard, Patentability, cit., 512.

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    Nuffield Council on Bioethics, The Ethics of Patenting DNA, London, 22 (2002).

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  12. 12.

    M. A. Chavez, Gene Patenting, cit.

  13. 13.

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  14. 14.

    D.B. Resnik, Owning the Genome; A Moral Analysis of DNA Patenting, 78, (2004).

  15. 15.

    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, Apr. 4, 1997, Council of Europe, http://conventions.coe.int (last visited Apr. 21, 2011).

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    G. Cataldi, La Convenzione del Consiglio d’Europa sui diritti umani e la biomedicina, in La tutela internazionale dei diritti umani. Norme, garanzie, prassi (L. Pineschi, ed.), Milano, 589 (2006).

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    M.D. Adams et al., Complementary DNA sequencing; expressed sequence tags and human genome project, Science, 1651, (1991).

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  36. 36.

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    Jeffrey P. Braff, et al. Patient-Tailored Medicine, Part One: The Impact of Race and Genetics on Medicine, Vol. 2, No. 1, J. Health & Life Sci. L. Pg. 1, (2008); S. S. Lee, Racializing Drug Design: Implications of Pharmacogenomics for Health Disparities, 95 Am. J. Pub. Health 2133-2138, 2137 (2005); M. Crews, Pharmacogenomics: Tailoring the Drug Approval Process, cit., 390–391; C. P. Milne, J. Tait, Evolution along the Government-Governance Continuum: FDA’s Orphan Products and Fast Track Programs as Exemplars of “WhatWorks” for Innovation and Regulation, 64 Food Drug L.J. 733, 736 (2009).

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    K. Outterson, Should Access to Medicines and TRIPS Flexibilities Be Limited to Specific Diseases? 34 Am. J. L. and Med. 279, 288 (2008), R.C. Bird, D.R. Cahoy, The Emerging BRIC Economies; Lessons from Intellectual Property Negotiation and Enforcement, 5 Nw. J. Tech. amp; Intell. Prop. 400, 411 (2007).

  49. 49.

    Giacomo Di Federico, Fundamental Rights in the EU; Legal Pluralism and Multi-Level Protection After the Lisbon Treaty, in The European Charter of Fundamental Rights; From Declaration to Binding Instrument (G. Di Federico, ed.), 38, 2011.

  50. 50.

    Antonella Losanno, Per un riequilibrio tra la brevettabilità di elementi isolati del corpo umano e la tutela dei diritti fondamentali della persona umana, Dir. Eccl. 2, 170 (2003).

  51. 51.

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    Amelia Torrice, Commento Art. 8, in La Carta dei diritti dell’unione europea. Casi e materiali (G. Bisogni, G. Bronzini, V. Piccone, eds), (120, 2009).

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    M. Brosiger et al., Der Reformvertrag von Lissabon, 20, 2008 (last visited April 21th 2011), http;//ssrn. com/abstract=1340861.

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  13. M. Ricolfi, La brevettazione delle invenzioni relative agli organismi geneticamente modificati, Riv. dir. ind. 2003, 01, 5; Peter Drahos, Biotechnology Patents, Markets and Morality, EIPR, 441, (1999).

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  14. J.M. Hall et al., Linkage of Early-Onset Familial Breast Cancer to Chromosome 17q21, 250 Science 1684, 1684 (1990).

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  15. R. Wooster et al., Localization of a Breast Cancer Susceptibility Gene, BRCA2, to Chromosome 13q12-13, 265 Science 2088, 2088–89 (1994).

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  16. K. Yoshida, Y. Miki, Role of BRCA1 and BRCA2 as regulators of DNA repair, transcription, and cell cycle in response to DNA damage, Cancer Sci., 866–871, 866 (2004).

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  20. A.M. Fialho, A.M. Chakrabarty, The Role and Importance in Intellectual Property Generation and Protection in Drug Development, in Emerging Cancer Therapy; Microbial Approaches and Biotechnological Tools (A.M. Fialho, A.M. Chakrabarty, eds.), 409, (2010).

    Chapter  Google Scholar 

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  22. M. Avery, Personalized Medicine and Rescuing “Unsafe” Drugs with Pharmacogenomics; A Regulatory Perspective, 65 Food Drug L.J. 37, 62, (2010); M. Crews, Pharmacogenomics; Tailoring the Drug Approval Process for Designer Drugs, 24 J. Contemp. Health L. amp; Pol’y 363, 390 (2008).

    Google Scholar 

  23. V.Z. Zencovich, La “comunione” di dati personali. un contributo al sistema dei diritti della personalità, Dir. Informatica, 5, (2009).

    Google Scholar 

  24. S.M. Gibbons et al., Lessons from European population genetic databases; comparing the law in Estonia, Iceland, Sweden and the United Kingdom, Eur J Health Law. 103, 103 (2005).

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  25. H. Jones, Bad Blood; The Tuskegee Syphilis Experiment, New York, 1993.

    Google Scholar 

  26. G. Corbie-Smith et al., Distrust, race, and research, in Archives of Internal Medicine 2458 (2002).

    Google Scholar 

  27. A.M.J. Berg, Biological and Molecular Mechanism for Sex Differences in Pharmacokinetics, Pharmacodynamics, and Pharmacogenetics; part I, “Journal of Women’s Health and Gender-Based Medicine”, 601–615, (2002).

    Google Scholar 

  28. K. Outterson, Should Access to Medicines and TRIPS Flexibilities Be Limited to Specific Diseases? 34 Am. J. L. and Med. 279, 288 (2008), R.C. Bird, D.R. Cahoy, The Emerging BRIC Economies; Lessons from Intellectual Property Negotiation and Enforcement, 5 Nw. J. Tech. amp; Intell. Prop. 400, 411 (2007).

    Google Scholar 

  29. Giacomo Di Federico, Fundamental Rights in the EU; Legal Pluralism and Multi-Level Protection After the Lisbon Treaty, in The European Charter of Fundamental Rights; From Declaration to Binding Instrument (G. Di Federico, ed.), 38, 2011.

    Google Scholar 

  30. Paolo Zatti, Rapporto medico-paziente e “integrità” della persona, in NGCC, 403 (2008).

    Google Scholar 

  31. Amelia Torrice, Commento Art. 8, in La Carta dei diritti dell’unione europea. Casi e materiali (G. Bisogni, G. Bronzini, V. Piccone, eds), (120, 2009).

    Google Scholar 

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    Google Scholar 

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Authors and Affiliations

  1. University Carlo Cattaneo, LIUC, Castellanza (VA), Italy

    Elena Falletti (Assistant Professor of Comparative Private Law)

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  1. Elena Falletti
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Editors and Affiliations

  1. Department of Juridical Sciences, University of Ferrara, Italy

    Roberto Bin , Sara Lorenzon  & Nicola Lucchi ,  & 

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Falletti, E. (2012). Pharmacogenetics and Fundamental Rights. In: Bin, R., Lorenzon, S., Lucchi, N. (eds) Biotech Innovations and Fundamental Rights. Springer, Milano. https://doi.org/10.1007/978-88-470-2032-0_17

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