Regulating genetic information - Exploring the options in legal theory

European Journal of Health Law

Volumn 21, Issue 5, 2014, Pages 425-453

  De Paor, Aisling ^a  

^a DUBLIN CITY UNIVERSITY   (Ireland)

Author keywords

data protection; genetics; non discrimination law; privacy; property; regulation

Indexed keywords

GENE; GENETIC PRIVACY; GENETIC SCREENING; HUMAN; LEGISLATION AND JURISPRUDENCE; PATENT; SOCIAL DISCRIMINATION;

GENES; GENETIC PRIVACY; GENETIC TESTING; HUMANS; PATENTS AS TOPIC; SOCIAL DISCRIMINATION;

EID: 84908671105     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/15718093-12341335     Document Type: Article

References (83)

1. See generally F. S. Collins and V. A. Mc Kusick, "Implications of the Human Genome Project for Medical Science", Journal of the American Medical Association 285(5) (2001) 540.
2. See also C. Terhune, "Spending on genetic tests is forecast to rise sharply by 2021", Los Angeles Times, 12. March 2012, retrieved 9 March 2014, http://articles.latimes.com/2012/mar/12/business/la-fi-genetic-test-20120312.
3. See generally S. Rajiv et al., "Genetic Screening: The vista of genomic medicine", Journal of Pharmacy and Bioallied Sciences 3 (1) (2011) 109.
4. see S. W. J. Lamberts and A. G. Uitterlinden, "Genetic Testing in Clinical Practice", Annual Review of Medicine 60 (2009) 431-442.
5. see K. E. Ormond et al., "Challenges in the clinical application of whole-genome sequencing", The Lancet 375 (2010) 9727.
6. See also J. Markoff, "Cost of Gene Sequencing Falls, Raising Hopes for Medical Advances", The New York Times, 7 March 2012. Retrieved 9 March 2014, http://www.nytimes.com/2012/03/08/technology/cost-of-genesequencing-falls-raising-hopes-for-medical-advances.html?pagewanted=all&-r=0.
7. M. A. Hamburg and F. S. Collins, "The Path to Personalized Medicine", New England Journal of Medicine 363 (4) (2010) 301.
8. A. de Paor, "US and EU Perspectives on Genetic Discrimination in Employment and Insurance: Striking a Balance in a Battlefield of Competing Rights", in L. Waddington et al. (eds.), 4 European Yearbook of Disability Law (Antwerp: Intersentia, 2013) p. 99.
9. See generally 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 (New Haven: Yale University Press, 1997).
10. See also G. J. Annas, "Genetic Privacy: There Ought to Be a Law", Texas Review of Law and Policy 4(1) (1999) 9, 11.
11. see M. A. Rothstein, "Genetic Exceptionalism and Legislative Pragmatism", Journal of Law, Medicine and Ethics (2007) 59.
12. See also R. Bayer, "Public Health Policy and the AIDs Epidemic: An End to HIV Exceptionalism?", New England Journal of Medicine 324 (1991) 1500, 1500-1504.
13. L. O. Gostin and J. G. Hodge Jr., "Genetic Privacy and the Law: An End to Genetics Exceptionalism", Jurimetrics Journal 40(21) (1999) 31.
14. S. Suter, "The Allure and Peril of Genetic Exceptionalism: Do we need Genetic Specific Legislation?", Washington University Law Quarterly 79(3) (2001) 669, 706.
15. D. Hellman, "What Makes Genetic Discrimination Exceptional?", in V. Gehring (ed.), Genetic Prospects: Essays on Biotechnology, Ethics and Public Policy (USA: Rowman and Littlefield, 2003), pp. 90-91.
16. L. O. Gostin, "Genetic Discrimination: The Use of Genetically Based Diagnostic and Prognostic Tests by Employers and Insurers", American Journal of Law and Medicine 17 (1 & 2) (1991) 109, 111.
17. J. L. Dolgin, "Personhood, Discrimination and the New Genetics", Brook Law Review 66 (2000-2001) 755, 786-787.
18. L. P. Francis, "You are Born with your Genes: Justice and Protection against Discrimination in the Use of Genetic Information", Mount Sinai Journal of Medicine 77(2) (2010) 188, 190.
19. S. Soina, "Genetic Testing legislation in Western Europe-a fluctuating regulatory target", Journal of Community Genetics 3 (2012) 143.
20. See also O. Varga et al., "Definitions of genetic testing in European legal documents", Journal of Community Genetics 3 (2012) 125.
21. J. H. Gerards and H. L. Janssen, "Regulation of Genetic and Other Health Information in a Comparative Context", European Journal of Health Law 13 (2006) 339, 346-347.
22. M. A. Rothstein, "Genetic Exceptionalism and Legislative Pragmatism", Hastings Center Report, No 4 (2005) 27, at 29.
23. T. Lemmens, "Selective Justice, Genetic Discrimination and Insurance: Should we Single out Genes in our Laws?", McGill Law Journal 45 (2000) 347, 349.
24. I.V. Motoc, "The International Law of Genetic Discrimination: The Power of Never Again", in T. Murphy (ed.), New Technologies and Human Rights (London: Oxford University Press, 2009).
25. A. Kaczorowska, European Union Law (2nd edn, New York: Routledge, 2011) p. 90.
26. See also, L. Senden, Soft Law in European Community Law (Portland OR: Hart Publishing, 2004).
27. F. Snyder, "The Effectiveness of European Community Law: Institutions, Processes, Tools and Techniques", The Modern Law Review 56(1) (1993) 19, 35.
28. T. McGleenan, "Legal Regulation of Genetic Technology in the United Kingdom: Hard or Soft Options", in S. Muller, J. Simon and J. W. Westing (eds.), Interdisciplinary Approaches to Gene Therapy: Legal, Ethical and Scientific Aspects (Berlin: Springer, 1997) p. 99-116.
29. L. Selden, "Soft Law, Self-Regulation and Co-Regulation in European Law-Where do they meet?", Electronic Journal of Comparative Law 9 (1) (2005). Retrieved 9 March 2014, http://www.ejcl.org/91/art91-3.html.
30. M. Otlowski et al., "Genetic Discrimination: International Perspectives", Annual Review of Human Genetics 13 (2012) 433, 446.
31. Concordat and Moratorium on Genetics. 2011. Retrieved 9 March 2014, https://www.gov. uk/government/uploads/system/uploads/attachment-data/file/216821/Concordat-and-Moratorium-on-Genetics-and-Insurance-20111.pdf.
32. T. McGleenan and U. Wiesling, "Insurance and Genetics: European Policy Options", European Journal of Health Law 7 (2000) 367, 372.
33. Council Directive 2000/78/EC of 27 November 2000 establishing a general framework for equal treatment in employment and occupation [2000] OJ L 303/16 ("Framework Directive").
34. see E. Ellis and P. Watson, EU Anti-Discrimination Law, 2nd edn. (Oxford: Oxford University Press, 2013).
35. See also D. Shiek and A. Lawson (eds.), European Union Non-Discrimination Law and Intersectionality (Farnham: Ashgate Publishing Ltd, 2011).
36. Genetic Information Nondiscrimination Act of 2008, Pub. L. No. 110-233, 122 Stat. 881 (2008).
37. United Nations Convention on the Rights of Persons with Disabilities G.A. Res 61/106.
38. A. Hendriks, "The UN Disability Convention and (Multiple) Discrimination: Should EU Non-Discrimination Law be Modelled Accordingly?", in G. Quinn and L. Waddington (eds.), 2 European Yearbook of Disability Law (Antwerp: Intersentia, 2010) p. 10.
39. A. Hendriks, "Protection against Genetic Discrimination and the Biomedicine Convention", in J. K. M. Gevers, E. H. Hondius and J. H. Hubben (eds.), Health Law, Human Rights and the Biomedicine Convention: Essays in Honor of Henriette Roscam Abbing (Leiden: Martinus Nijhoff Publishers, 2005) p. 210.
40. W. Hardie, Aristotle's Ethical Theory, 2nd edn. (Oxford: Clarendon Press, 1980).
41. M. P. Banton, "Discrimination entails comparisons", in L. Titia and P. R. Rodrigues (eds.), Non Discrimination Law: Comparative Perspectives (Leiden: Martinus Nijhoff Publishers, 1999).
42. A. C. Hendriks, "Different Definition-Same Problems-One Way Out?", in M. L. Breslin and S. Yee (eds.), Disability Rights Law and Policy: International and National Perspectives (New York: Transnational Publishers, 2002) p. 195.
43. G. Quinn, "Disability Discrimination Law in the EU", in H. Meenan (ed.), Equality Law in an Enlarged European Union-Understanding the Article 13 Directives (Cambridge: Cambridge University Press, 2007), pp. 243-246.
44. See also L. Alexander, "What Makes Wrongful Discrimination Wrong; Biases, Preferences, Stereotypes and Proxies", University of Pennsylvania Law Review 141(1) (1992) 149.
45. J. Gerards, "General Issues Concerning Genetic Information", in J. H. Gerards, A. W. Heringa and H. L. Janssen (eds.), Genetic Discrimination and Genetic Privacy in a Comparative Perspective (Antwerp: Intersentia, 2005) p. 24.
46. J. Roberts, "The Genetic Information Nondiscrimination Act as an Antidiscrimination Law", Notre Dame Law Review 86 (2) (2011) 597, 617.
47. See generally P. Lambert, Data Protection law in Ireland: sources and issues (Dublin: Clarus Press, 2013).
48. See also P. Schwartz, "European Data Protection Law and Restrictions on International Data Flows", Iowa Law Review 80 (1994) 471, 471
49. M. Rotenberg and D. Jacobs, "Updating the law of information privacy: the new framework of the European Union", Harvard Journal of Law and Policy 36(2) (2013) 605, 609-611.
50. Charter of Fundamental Rights of the European Union, 7 December 2000, Official Journal of the European Communities, 18 December 2000 (2000/C 364/01), Articles 7 and 8.
51. M. Taylor, Genetic Data and the Law-A Critical Perspective on Privacy Protection (Cambridge: Cambridge University Press, 2012) p. 17.
52. see generally, S. T. Margulis, "Conceptions of privacy: current status and next steps", Journal of Social Issues 33(3) (1977) 5, 10.
53. See also, S. T. Margulis, "Privacy as a social issue and a behavioural concept", Journal of Social Issues 9(2) (2003) 243, 245.
54. G. Laurie, "The Most Personal Information of All: An Appraisal of Genetic Privacy in the Shadow of the Human Genome Project", International Journal of Law, Policy and Family 10 (1996) 74-101.
55. G. Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms (Cambridge: Cambridge University Press, 2002) p. 6.
56. See also G. Laurie, "Challenging Medical-Legal Norms: The Role of Autonomy, Confidentiality, and Privacy in Protecting Individual and Familial Group Rights in Genetic Information", The Journal of Legal Medicine 22 (1) (2001) 27.
57. S. Suter, "Disentangling Privacy from Property: Toward a Deeper Understanding of Genetic Privacy", The George Washington Law Review 72 (2003-2004) 737, 770.
58. See also K. Greenwalt, "Privacy and Its Legal Protection", Hastings Center Study 2 (1974) 45.
59. R. A. Spinello, "Property rights in genetic information", Ethics and Technology 6 (2004) 29, 30.
60. See also B. Knoppers, EMBO Newsletter, Issue 24 (Summer 2013). Retrieved 9 March 2014, http://www.embo.org/news/emboencounters/issue-24/the-limits-of-privacy.
61. D. F. Partlett "Misuse of Genetic Information: The Common Law and Professionals' Liability", Washburn Law Journal 42 (2003) 489, 497.
62. W. Blackstone, Commentaries on the Laws of England Volume 2: A Facsimile of the First Edition of 1765-1969 (Chicago: University of Chicago Press, 1979).
63. J. Penner, The Idea of Property in Law (Oxford: Oxford University Press, 1997) p. 1.
64. A. L. Corbin, "Legal Analysis and Terminology", Yale Law Journal 29 (1919) 163, 163.
65. L. C. Becker, Property Rights: Philosophical Foundations (London: Routledge 1980) p. 18.
66. C. M. Valerio Barrad, "Genetic Information and Property Theory", Northeastern University Law Review 87 (3) (1992-1993) 1037, 1049.
67. Charter of Fundamental Rights of the European Union, 7 December 2000, Official Journal of the European Communities, 18 December 2000 (2000/C 364/01), Article 17.
68. First Protocol to the Convention for the Protection of Human Rights and Fundamental Freedoms CETS No. 009 [1952].
69. Case 44/79 Liselotte Hauer v. Land Rheinland-Pfalz 1979 ECR 3727.
70. M. Yesley, "Protecting Genetic Difference", Berkeley Technology Law Journal 13 (1998) 653, 664.
71. see E. R. Gold, "Body Parts: Property rights and the ownership of Human Biological Materials", Harvard Journal of Law and Technology 10 (2) (1997) 369.
72. D. B. Resnik, "The Commercialization of Human Stem Cells: Ethical and Policy Issues", Health Care Analysis 10 (2002) 127, 140.
73. L. Oystein Ursin, "Privacy and Property in the Biobank Context", Healthcare Ethics Committee Forum 22 (2010) 211, 221.
74. M. Stulic, "Genetic Non Discrimination, Privacy and Property Rights", Murdoch University Electronic Journal of Law 7 (2000) 2. Retrieved 9 March 2014, http://worldlii.austlii.edu.au/au/journals/MurUEJL/2000/19.html.
75. Moore v. Regents of the University of California (1990) 51 Cal. 3d, 120, 271 Cal. Rptr. 146; 793 P2d. 479.
76. B. H. Hall, "Patents and Patent Policy", Oxford Review of Economic Policy (2007) 1.
77. See also R. Feldman, Rethinking Patent Law (Cambridge MA: Harvard University Press, 2012).
78. S. Soini et al., "Patenting and licensing in genetic testing: ethical, legal and social issues", European Journal of Human Genetics 16 (2008) 10.
79. The Association for Molecular Pathology et al v. Myriad Genetics, Inc et al 569 U.S. 12-398 (2013).
80. See also A. S. Kesselheim et al., "Gene Patenting-the Supreme Court finally speaks", New England Journal of Medicine (2013). (Massachusetts Medical, 2013). Retrieved 9 March 2014, http://www.nejm.org/doi/pdf/10.1056/NEJMhle1308199.
81. see G. Matthijs, "The European opposition against the BRCA gene patents", Familial Cancer 5 (2006) 95.
82. P. T. Kim, "Genetic Discrimination, Genetic Privacy: Rethinking Employee Protections for a Brave New Workplace", Northwestern University Law Review 96 (2002) 1497, 1498.
83. See also A. Hendriks, "Genetic Discrimination: How to Anticipate Predictable Problems?", European Journal of Health Law 9 (2002) 87.