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Challenges of Personalized Medicine: Socio-Legal Disputes and Possible Solutions

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Personalized Medicine

Part of the book series: Europeanization and Globalization ((EAG,volume 2))

Abstract

We are living in an era of epic transformation and advancement of medical science and technology, which allows us to gather comprehensive information about a person’s health and predict and even prevent a disease. The focus on personalized or individualized medicine presents new challenges, not only in the fields of medical sciences, biotechnology, and nanotechnology but also in the fields of social law and economy, where the consequences of medical activities are manifested. The existence of technically available and possible methods of diagnostic and treatment raises the question whether there could be a constitutionally guaranteed fundamental right of access to them. What consequences would the introduction of personalized medicine in compulsory health insurance systems have? Is it possible, would it destruct or reconstruct the essential features of compulsory health insurance? These are just some of the issues this paper aims to address.

Professor Nada Bodiroga-Vukobrat Ph.D., Head of Department of EU Public Law, Faculty of Law, University of Rijeka, Rijeka, Croatia.

 Professor Hana Horak, Ph.D., Head of Department of Law, University of Zagreb Faculty of Economics and Business, University of Zagren, Zagreb, Croatia.

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Notes

  1. 1.

    Radolović (2006), p. 134; Dulčić and Bodiroga-Vukobrat (2008), p. 372.

  2. 2.

    Radolović (2006), p. 133.

  3. 3.

    Authors’ translation from German, see Damm (2009), pp. 303 and 312.

  4. 4.

    For various definitions of these terms, see, e.g., Radder et al. (2014), Bottinger (2007), Niederlag et al. (2010), Qattan et al. (2012), Pavelić et al. (2015), and Taupitz (2011) and references contained therein.

  5. 5.

    Niederlag et al. (2010), p. 776.

  6. 6.

    Kroemer (2012), p. 12.

  7. 7.

    The Royal Society and the Royal Academy of Engineering (2004).

  8. 8.

    See, e.g., Juengst (1995); Khoury et al. (2000), p. 6; Nordgren (2001), p. 159.

  9. 9.

    Deutscher Bundestag (2009) (authors’ translation from German).

  10. 10.

    German Academy of Sciences Leopoldina et al. (2010).

  11. 11.

    German Academy of Sciences Leopoldina et al. (2010), p. 14.

  12. 12.

    Constitution of the World Health Organisation (1946).

  13. 13.

    United Nations, Millenium Development Goals (2000).

  14. 14.

    Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (1997), Article 3.

  15. 15.

    Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes (2008).

  16. 16.

    Convention for the Protection of Human Rights and Fundamental Freedoms (1950).

  17. 17.

    Charter of Fundamental Rights of the EU, Article 2.

  18. 18.

    See, e.g., Directive 2006/54/EC of the European Parliament and of the Council of 5 July 2006 on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation (recast); Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin.

  19. 19.

    Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

  20. 20.

    Article 8(3) of Data Protection Directive 95/46/EC.

  21. 21.

    European Commission (2012a).

  22. 22.

    Eecke et al. (2012), pp. 19–22.

  23. 23.

    Gilbert (2012).

  24. 24.

    Gilbert (2012), p. 21.

  25. 25.

    Numerous cases of the European Court of Human Rights, e.g., S. and Marper v. the United Kingdom, ECHR App. No. 30562/04 and 30566/04, Judgement of 4.12.2008, point to the need for a clearer definition of the right of a person to seek deletion of his personal data from public registers, etc. See also a recent Judgment (13.5.2014) of the Court of Justice of the EU in the case C-131/12 Google Spain SL, Google Inc. v. Agencia Espanola de Proteccion de Datos, Mario Costeja Gonzales.

  26. 26.

    Constitution of the Republic of Croatia, Article 59.

  27. 27.

    Constitution of the Republic of Croatia, Article 70.

  28. 28.

    Pavelić et al. (2015).

  29. 29.

    Li (2011), p. 403.

  30. 30.

    Li (2011), p. 403.

  31. 31.

    Li (2011), p. 412.

  32. 32.

    Li (2011), p. 412.

  33. 33.

    See Kollek et al. (2004), p. 138: “Once obtained, they [i.e. data] stick to the individuals their entire life” (authors’ translation from German).

  34. 34.

    Taupitz (2011), p. 225.

  35. 35.

    Deutscher Bundestag (2009), pp. 14 and 148.

  36. 36.

    For a definition of the principle of solidarity, see, e.g., Kingreen (2003), Martinović (2014), and Hatzopoulos (2009).

  37. 37.

    Martinović (2014), p. 56.

  38. 38.

    Hatzopoulos (2009), p. 769.

  39. 39.

    Kingreen (2003), p. 252.

  40. 40.

    On the tension between personalised medicine and basic principles of compulsory health insurance, see Müller (2012) and Raspe (2012).

  41. 41.

    See more in Martinović (2014).

  42. 42.

    Deutscher Bundestag (2009), pp. 15 and 148; Damm (2011), p. 12; Vogenberg et al. (2010a), p. 642. On possible future development strategies for integration of personalised medicine in health insurance, see, e.g., Vogenberg et al. (2010b).

  43. 43.

    Damm (2011), p. 12.

  44. 44.

    Deutscher Bundestag (2009), p. 15; Raspe (2012), p. 64.

  45. 45.

    Deutscher Bundestag (2009), pp. 15 and 148.

  46. 46.

    Bottinger (2007), p. 20.

  47. 47.

    Damm and König (2008), pp. 62 and 68; Wiese (2005), p. 2073; Wiese (2009), p. 2198.

  48. 48.

    Deutscher Bundestag (2009), pp. 18, 128, 154.

  49. 49.

    Deutscher Bundestag (2009), p. 12 and 151.

  50. 50.

    Deutscher Bundestag (2009), p. 151.

  51. 51.

    Deutscher Bundestag (2009), p. 152.

  52. 52.

    Deutscher Bundestag (2009), p. 145.

  53. 53.

    Deutscher Bundestag (2009), p. 145.

  54. 54.

    Feuerstein et al. (2002).

  55. 55.

    Damm (2007).

  56. 56.

    European Commission (2011), p. 12.

  57. 57.

    European Commission (2013), p. 16.

  58. 58.

    Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. The pending Commission's Proposal for a revision of this Directive and adoption of a Regulation on in vitro medical devices of 2012 explicitly includes diagnostics used in the context of personalised medicine in the definition of an IVD. See European Commission (2012b).

  59. 59.

    Directive 2001/83/EC on the Community code relating to medicinal products for human use.

  60. 60.

    The new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, entered into force on 16 June 2014 but will apply no earlier than 28 May 2016. In the transition period, all clinical trials in the EU are to be performed in accordance with Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The new Clinical Trials Regulation is aimed at facilitating the conduct of clinical trials, particularly for personalised medicines, where diseases are increasingly narrowly defined. See more in European Commission (2013), p. 19.

  61. 61.

    Data Protection Directive 95/46/EC.

  62. 62.

    See, e.g., European Commission (2010), p. 7: “Personalised medicine needs to be developed and be introduces into clinical practice in line with the two core principles of European health systems: health equity and universal access …” See also European Commission (2011).

  63. 63.

    Pavelić et al. (2015), p. 2.

  64. 64.

    National Academy of Sciences (2009).

  65. 65.

    Agency for Health Care Research and Quality (2001).

  66. 66.

    Vogenberg et al. (2010a), p. 626.

  67. 67.

    The Privacy Act of 1974, 5 U.S.C. §552a.

  68. 68.

    The Electronic Communication Privacy Act of 1986, 18 U.S.C. §2510-2521, 2701–2710.

  69. 69.

    The Americans with Disabilities Act, Pub.L. 101–336, 104 Stat. 327.

  70. 70.

    The Health Insurance Portability and Accountability Act, Pub.L. 104–191; 110 Stat. 1936.

  71. 71.

    The American Recovery and Reinvestment Act of 2009, Pub.L. 111–5; 123 Stat. 115.

  72. 72.

    Vogenberg et al. (2010a), p. 629.

  73. 73.

    Institute of Medicine of the National Academies (2009), p. 3.

  74. 74.

    The Genetic Information Nondiscrimination Act of 2008, Pub.L. 110–233, 122 Stat. 881.

  75. 75.

    U.S. Food and Drug Administration (2007a).

  76. 76.

    U.S. Food and Drug Administration (2007b).

  77. 77.

    A valuable overview of instruments and policy papers in relation to the federal oversight of genetic/genomic testing is provided on the Internet site of Duke Center for Personalized and Precision Medicine (2015). http://dukepersonalizedmedicine.org/policy/regulatorylegal. Accessed 20 Jan 2015.

  78. 78.

    The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 244,000 laboratory entities. See more at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia. Accessed 10 Jan 2015.

  79. 79.

    Vogenberg et al. (2010a), p. 631; Rugnetta and Kramer (2009).

  80. 80.

    See more on this issue, e.g., Marchant et al. (2006).

  81. 81.

    Personalized Medicine Coalition (2014).

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Bodiroga-Vukobrat, N., Horak, H. (2016). Challenges of Personalized Medicine: Socio-Legal Disputes and Possible Solutions. In: Bodiroga-Vukobrat, N., Rukavina, D., Pavelić, K., Sander, G. (eds) Personalized Medicine. Europeanization and Globalization, vol 2. Springer, Cham. https://doi.org/10.1007/978-3-319-39349-0_3

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