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Adjusting the Individualistic Framework of Protection in Human Genetic Research

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Biotech Innovations and Fundamental Rights

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Abstract

This contribution focuses on the strictness of the individualistic framework of protection adopted in genetic research. Traditional limits to scientific research, hinging on consent and privacy, prove in some contexts to be ineffective, both for the proper development of research, and for the protection of involved interests. The main reason of this inappropriateness seem be rooted into the shared nature of human genome, which imposes the consideration of an ultra-individual dimension. In particular, the analysis of some specific fields of genetic research, and the consideration of some of its outcomes, recall the relevance of more general principles, such as equality and non-discrimination which come to extend their efficacy out of the boundaries of employment and insurance, within which they are usually confined. These principles prove to be essential instruments for the striking of a proper balance among all the interests involved in the complex activities related to genetic research.

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Notes

  1. 1.

    “A new, legally relevant social group” which, according to the Document on “Genetic Data” of the Article 29 Data protection Working Party (adopted on 17 March 2004), “also consists of entities outside the family circle”.

  2. 2.

    Among the others, R(97)5 of the Council of Europe on the Protection of Medical Data gives the idea of the multi-dimensional nature of genetic data defining them 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”

  3. 3.

    The term has been introduced by A. Lippman, Prenatal Genetic Testing and Screening: Constructing Needs and Reinforcing Inequities, in 17 American Journal of Law & Medicine 15, 1991, at 18.

  4. 4.

    A. Rouvroy, Human Genes and Neoliberal Governance: A Foucauldian Critique, Oxon-New York, 2008, at 124.

  5. 5.

    A. Lippman, cit., at 19.

  6. 6.

    A. Rouvroy, cit., at 20–21.

  7. 7.

    H. Boussard, Individual Human Rights in Genetic Research. Blurring the Line between Collective and Individual Interests, in T. Murphy (ed.), New Technologies and Human Rights, Oxford, 2009, at 270.

  8. 8.

    On these assumptions is based the theory of “genetic exceptionalism”. This expression has been introduced by T.H. Murray, Genetic Exceptionalism and Future Diaries: is genetic information different from other medical information?, in M.A. Rothstein (ed.), Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era, New Haven-London, 1997, addressing “the claim that genetic information is sufficiently different from other kinds of health-related information that it deserves special protection or other exceptional measures”, at 61.

  9. 9.

    Among others, R. Chadwick, K. Berg, Solidarity and equity: new ethical frameworks for genetic databases, in Nature Reviews. Genetics, Vol. 2, April 2001; B.M. Knoppers, R. Chadwick, Human Genetic Research: Emerging Trend in Ethics, in Nature Reviews. Genetics, Vol. 6, January 2005; J.E. Lunshof, R. Chadwick, D.B. Vorhaus, G.M. Church, From Genetic Privacy to Open Consent, in Nature Reviews. Genetics, Vol. 9, May 2008; D. Mascalzoni, A. Hicks, P.P. Pramstaller, Consenting in Population Genomics as an Open Communication Process, in Studies in Ethics, Law, and Technology, Vol. 3, Iss. 1, 2009.

  10. 10.

    A. Rouvroy, cit., at 3.

  11. 11.

    Idem, at 124.

  12. 12.

    According to B.K. Hall, Evolutionary Developmental Biology, Norwell, 1999, “(e)pigenetics or epigenetic control is the sum of the genetic and non-genetic factors acting upon cells to control selectively the gene expression that produces increasing phenotypic complexity during development”, at 114.

  13. 13.

    B. Elger, Consent and Use of Samples, in B. Elger, N. Biller-Adorno, A. Mauron, A.M. Capron, Ethical Issues in Governing Biobanks. Global Perspectives, Aldershot, 2008, at 57.

  14. 14.

    Nuremberg Code, Directives for Human Experimentation, 1946.

  15. 15.

    WMA Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Subjects, June 1964 .

  16. 16.

    “Which is usually addressed to a specific research project. Blanket consent implies, on the contrary, the acceptance of “future as yet unspecified projects” (WHO, Proposed international guidelines on ethical issues in medical genetics and genetic services, 1998). Intermediate models have been introduced, which make reference to “related projects” (for instance, art. 60 of the Spanish Ley 14/2007, de Investigación biomédica, 3 July 2007 recalls: “otras líneas de investigación relacionadas con la inicialmente propuesta”.

  17. 17.

    D. Mascalzoni, A. Hicks, P.P. Pramstaller, cit., 2009.

  18. 18.

    A. Cambon-Thomsen, The social and ethical issues of post-genomic human biobanks, in Nature Reviews. Genetics, Vol. 5, December 2004, at 866–873.

  19. 19.

    This is the case of the contested “blanket” consent, see supra footnote 16.

  20. 20.

    In this sense goes the promotion, in different experiences, of the “broad” consent.

  21. 21.

    J.E. Lunshof, R. Chadwick, D.B. Vorhaus, G.M. Church, cit., passim.

  22. 22.

    R.M. Green, Babies by design. The Ethics of Genetic Choice, New Haven-London, 2007, at 159.

  23. 23.

    For a criticism towards this approach see N.C. Manson, O. O’Neill, Rethinking Informed Consent in Bioethics, Cambridge, 2007.

  24. 24.

    A. Buchanan et al., From Chance to Choice, Cambridge, 2000, at 6.

  25. 25.

    A variant of the former, which allows for more genes to be tested at once.

  26. 26.

    The distinction between the two terms is not clear. The word “pharmacogenetics” (introduced by F. Vogel , Moderne problem der humangenetik. Ergeb Inn Med U Kinderheilk. 1959;12:52–125) refers to the study of inherited differences (variation) in drug metabolism and response, while the newer term “pharmacogenomics” refers to the general study of all the many different genes that determine drug behavior. By now, anyway, the terms are used quite interchangeably.

  27. 27.

    O. Feeney, Germ-line Enhancements, Inequalities and the (In)egalitarian Ethos, in Studies in Ethics, Law, and Technology, Vol. 4, Iss. 2, Article 2, 2010, at 1.

  28. 28.

    Consensus should be found with regard to dramatically serious conditions.

  29. 29.

    Genetics itself made the distinction even more unclear, introducing notions such as that of “predisposition”.

  30. 30.

    Recommendation R 934(1982) of the Council of Europe, on genetic engineering, adopted on 26 January 1982.

  31. 31.

    H. Nickens, The Genome Project and Health Services for Minority Populations, in T.H. Murray, M.A. Rothstein, R.F. Murray (eds.), The Human Genome Project and the Future of Health Care, Bloomington, 1996, at 58.

  32. 32.

    M.H. Shapiro, The Impact of Genetic Enhancement on Equality, in 34 Wake Forest Law Review 561, 621, 1999.

  33. 33.

    Recently, among others, N. Cohen, Pharmacogenomics and Personalized Medicine, Totowa, 2010, passim.

  34. 34.

    J. Kahn, Race in a bottle, in Scientific American, August 2007.

  35. 35.

    See the work of L.L. Cavalli-Sforza, aimed at demonstrating how “(t)he classification into races has proved to be a futile exercise” (L.L. Cavalli-Sforza, P. Menozzi, A. Piazza, The history and geography of human genes, Princeton, 1994, at 19.

  36. 36.

    M.A. Rothstein (ed.), Pharmacogenomics: social, ethical, and clinical dimensions, Hoboken, 2003.

  37. 37.

    Similar provisions can be found as well in Japan and Australia.

  38. 38.

    Tax incentives and market exclusivity up to 7 years.

  39. 39.

    The research activity is not considered.

  40. 40.

    According to the Act, a rare disease is “any disease or conditions which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug”.

  41. 41.

    Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products.

  42. 42.

    “(L)ife-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community” or “life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment” (Art. 3.1.a).

  43. 43.

    P. Atkinson, P. Glasner, M. Lock (eds.), Handbook of Genetics and Society. Mapping the New Genomic Era, London, 2009, at 401.

  44. 44.

    M.J. Mehlman, Wondergenes: Genetic Enhancement and the Future Society, Bloomington, 2003, at 120.

References

  1. A. Lippman, Prenatal Genetic Testing and Screening: Constructing Needs and Reinforcing Inequities, in 17 American Journal of Law & Medicine 15, 1991, at 18.

    Google Scholar 

  2. A. Rouvroy, Human Genes and Neoliberal Governance: A Foucauldian Critique, Oxon-New York, 2008, at 124.

    Google Scholar 

  3. H. Boussard, Individual Human Rights in Genetic Research. Blurring the Line between Collective and Individual Interests, in T. Murphy (ed.), New Technologies and Human Rights, Oxford, 2009, at 270.

    Google Scholar 

  4. R. Chadwick, K. Berg, Solidarity and equity: new ethical frameworks for genetic databases, in Nature Reviews. Genetics, Vol. 2, April 2001; B.M. Knoppers, R. Chadwick, Human Genetic Research: Emerging Trend in Ethics, in Nature Reviews. Genetics, Vol. 6, January 2005; J.E. Lunshof, R. Chadwick, D.B. Vorhaus, G.M. Church, From Genetic Privacy to Open Consent, in Nature Reviews. Genetics, Vol. 9, May 2008; D. Mascalzoni, A. Hicks, P.P. Pramstaller, Consenting in Population Genomics as an Open Communication Process, in Studies in Ethics, Law, and Technology, Vol. 3, Iss. 1, 2009.

    Google Scholar 

  5. B. Elger, Consent and Use of Samples, in B. Elger, N. Biller-Adorno, A. Mauron, A.M. Capron, Ethical Issues in Governing Biobanks. Global Perspectives, Aldershot, 2008, at 57.

    Google Scholar 

  6. A. Cambon-Thomsen, The social and ethical issues of post-genomic human biobanks, in Nature Reviews. Genetics, Vol. 5, December 2004, at 866–873

    Google Scholar 

  7. R.M. Green, Babies by design. The Ethics of Genetic Choice, New Haven-London, 2007, at 159.

    Google Scholar 

  8. N.C. Manson, O. O’Neill, Rethinking Informed Consent in Bioethics, Cambridge, 2007.

    Google Scholar 

  9. A. Buchanan et al., From Chance to Choice, Cambridge, 2000, at 6.

    Google Scholar 

  10. O. Feeney, Germ-line Enhancements, Inequalities and the (In)egalitarian Ethos, in Studies in Ethics, Law, and Technology, Vol. 4, Iss. 2, Article 2, 2010, at 1.

    Article  Google Scholar 

  11. H. Nickens, The Genome Project and Health Services for Minority Populations, in T.H. Murray, M.A. Rothstein, R.F. Murray (eds.), The Human Genome Project and the Future of Health Care, Bloomington, 1996, at 58.

    Google Scholar 

  12. M.H. Shapiro, The Impact of Genetic Enhancement on Equality, in 34 Wake Forest Law Review 561, 621, 1999.

    Google Scholar 

  13. J. Kahn, Race in a bottle, in Scientific American, August 2007.

    Google Scholar 

  14. L.L. Cavalli-Sforza, aimed at demonstrating how “(t)he classification into races has proved to be a futile exercise” (L.L. Cavalli-Sforza, P. Menozzi, A. Piazza, The history and geography of human genes, Princeton, 1994, at 19.

    Google Scholar 

  15. M.J. Mehlman, Wondergenes: Genetic Enhancement and the Future Society, Bloomington, 2003, at 120.

    Google Scholar 

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Authors and Affiliations

  1. University of Trento, Italy

    Marta Tomasi (PhD candidate in Comparative and European Legal Studies)

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

    Roberto Bin , Sara Lorenzon  & Nicola Lucchi ,  & 

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Tomasi, M. (2012). Adjusting the Individualistic Framework of Protection in Human Genetic Research. 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_15

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