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International Biomedical Laws in the Field of Genetic Interventions

  • Pin Lean Lau
Chapter

Abstract

This chapter imports an international dimension into the discourse of genetic interventions. In examining a selection of international biomedical laws in the field of genetic interventions, the international human rights dimensions that are protected in these biomedical instruments are highlighted. Of particular note is that despite the existence of these international human rights instruments, some key bioethical issues still remain unresolved, which points to a lack of international consensus and concerted will at bridging the gap that may actualize the resolution of these problems. I summarize that two of the main bioethical issues (the determination of human dignity as a grounded normative value, and germ line genetic interventions) still lead to divergent opinions in both bioethical and legal circles, and in this, demonstrates shortcomings that impact considerably on the human rights discourse.

References

  1. A, B and C v Ireland (Application No 25575/05) [2010] HUDOC (Grand Chamber, European Court of Human Rights)Google Scholar
  2. Addis A (2015) Human dignity in comparative constitutional context: in search of an overlapping consensus. J Int Comp Law 2:1Google Scholar
  3. Andorno R (2002) Biomedicine and international human rights law: in search of a global consensus. Bull World Health Org 5Google Scholar
  4. Andorno R (2009) Human dignity and human rights as a common ground for a global bioethics. J Med Philos 34:223CrossRefGoogle Scholar
  5. Andorno R (2013a) Principles of international biomedical law. In: Principles of international biolaw: seeking common ground at the intersection of bioethics and human rights. Editions BruylantGoogle Scholar
  6. Andorno R (2013b) The dual role of human dignity in bioethics. Med Health Care Philos 16:967CrossRefGoogle Scholar
  7. Assembly UG (1979) Convention on the elimination of all forms of discrimination against Women. 20 Retrieved April 2006Google Scholar
  8. Baltimore D et al (2015) A prudent path forward for genomic engineering and germline gene modification. Science 348:36CrossRefGoogle Scholar
  9. Barak A (1996) Constitutional human rights and private law. Rev Const Stud III:218Google Scholar
  10. Barak A (2015) Human dignity: the constitutional value and the constitutional right. Cambridge University PressGoogle Scholar
  11. Barnett RE (1986) Four senses of the public law-private law distinction. Harv J Law Public Policy 9:267Google Scholar
  12. Bawden T (27 July 2017) Scientists call for new rules on GM designer babies. iNews. https://inews.co.uk/news/health/new-rules-will-be-needed-to-exploit-designer-baby-breakthrough-in-britain. Accessed 27 Jan 2018
  13. Black J (1998) Regulation as facilitation: negotiating the genetic revolution. Mod Law Rev 61:621CrossRefGoogle Scholar
  14. Boer D, Boehnke K (2015) What are values? Where do they come from? A developmental perspective. In: Brosch T et al (eds) Handbook of value: perspectives from economics, neuroscience, philosophy, psychology and sociology. Oxford University PressGoogle Scholar
  15. BVerfGE 75 [1987] Verfassungsgericht 369 1 BvR 313/85Google Scholar
  16. C-528/16 Fédération Nature & Progrès v Premier Ministre, Ministre de l’agriculture, de l’agroalimentaire et de la forêt [2018] Court of Justice of the European Union C-528/16, CuriaGoogle Scholar
  17. Chen QB (1994) Chinese Constitutional Law. BLJ 26:77Google Scholar
  18. Chen Z-H et al (2017) Targeting genomic rearrangements in tumor cells through Cas9-mediated insertion of a suicide gene. Nature Biotechnol 35:543CrossRefGoogle Scholar
  19. Christine Goodwin v the United Kingdom (Application No 28957/95) [2002] HUDOC (Grand Chamber, European Court of Human Rights)Google Scholar
  20. Coggon J, Miola J (2011) Autonomy, liberty, and medical decision-making. Camb Law J 70:523CrossRefGoogle Scholar
  21. Committee on Science, Technology, and Law, Policy and Global Affairs and National Academies of Sciences, Engineering, and Medicine (2016) Olson S (ed) International summit on human gene editing: a global discussion. National Academies PressGoogle Scholar
  22. Commune de Morsang-sur-Orge v Societe Fun Production et MWackenheim [1995] Conseil d’Etat 136727, Cons EtatGoogle Scholar
  23. Conseil de l’Europe (1953) Convention for the protection of human rights and fundamental freedomsGoogle Scholar
  24. Conseil de l’Europe (1997) 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. Editions du Conseil de l’Europe. http://193.205.211.30/lawtech/images/lawtech/law/convenzioneoviedo.pdf
  25. Costa J-P (2013) Human Digity in the jurisprudence of the European Court of Human Rights. In: McCrudden C (ed) Understanding human dignity. The British AcademyGoogle Scholar
  26. Cwik B (2017, 1911) Designing ethical trials of germline gene editing. New Engl J Med 377Google Scholar
  27. Cyranoski D, Reardon S (22 April 2015) Chinese Scientists Genetically Modify Human Embryos. Nature News. http://www.nature.com/news/chinese-scientists-genetically-modify-human-embryos-1.17378
  28. de Anarclens P (2007) The United Nations as a social and economic regulator. In: de Sanarclens P, Kazancigli A (eds) Regulating globalization, critical approaches to global governance. United Nations University, pp 8–35Google Scholar
  29. Department of Jurisconsult R and LD, ‘Bioethics and the Case-Law of the Court’ (Council of Europe / European Court of Human Rights 2016) Research ReportGoogle Scholar
  30. Douglas v Hello! Ltd [2005] EWCA Civ 595Google Scholar
  31. Elbarbary RA et al (2017) Tudor-SN–mediated endonucleolytic decay of human cell MicroRNAs promotes G 1 /S phase transition. Science 356:859CrossRefGoogle Scholar
  32. European Commission JRC Science for Policy (2018) JRCF7- Knowledge Health and Consumer Safety, Overview of EU National Legislation on Genomics. European Commission. EUR29404EN http://publications.jrc.ec.europa.eu/repository/bitstream/JRC113479/policy_report_-_review_of_eu_national_legislation_on_genomics_-_with_identifiers.pdf
  33. European Medicines Agency (2018) Report of the EMA Expert Meeting on Genome Editing Technologies Used in Medicinal Product Development. European Medicines Agency. EMA/47066/2018Google Scholar
  34. Federal Constitution of Malaysia 1957Google Scholar
  35. Fischer-Lescano A, Teubner G (2004) Regime collisions: the vain search for legal unity in the fragmentation of global law. Mich J Int Law 25:99–1045Google Scholar
  36. Foster C (2011) Human dignity in bioethics and law. HartGoogle Scholar
  37. Fox D (2010) Retracing liberalism and remaking nature: designer children, research embryos, and featherless chickens. Bioethics 24:170CrossRefGoogle Scholar
  38. Gabbatis J (14 February 2018) Dolly the Sheep: 15 years after her death, cloning still has the power to shock. The Independent. https://www.independent.co.uk/news/science/dolly-the-sheep-cloning-15-years-death-future-humans-monkeys-what-next-a8208896.html
  39. Geller T (2016) In privacy law, it’s the U.S. vs. the world. Commun ACM 59:21CrossRefGoogle Scholar
  40. Gillon R (1985) Autonomy and the principle of respect for autonomy. Br Med J (Clinical research ed.) 290:1806CrossRefGoogle Scholar
  41. Groll D, Lott M (2015) Is there a role for “Human Nature” in debates about human enhancement? Philosophy 90:623CrossRefGoogle Scholar
  42. Guttinger S (2017) Trust in science: CRISPR–Cas9 and the Ban on human Germline editing. Sci Eng EthicsGoogle Scholar
  43. Hallich O (2017) Sperm donation and the right to privacy. New Bioethics 23:107CrossRefGoogle Scholar
  44. Harlow C (1980) “Public” and “Private” law: definition without distinction. Mod Law Rev 43:241CrossRefGoogle Scholar
  45. Harvard TH (2016) Chan School of Public Health and STAT, ‘The Public and Genetic Editing, Testing and Therapy’. Harvard TH Chan School of Public Health. https://cdn1.sph.harvard.edu/wp-content/uploads/sites/94/2016/01/STAT-Harvard-Poll-Jan-2016-Genetic-Technology.pdf
  46. Hawking SW (2005) The theory of everything: the origin and fate of the universe. Phoenix BooksGoogle Scholar
  47. Hong M et al (2017) Correction of a pathogenic gene mutation in human embryos. Nature 548:413Google Scholar
  48. House of Representatives, The Parliament of the Commonwealth of Australia, ‘Australian Bill of Rights Bill 2017’. https://www.legislation.gov.au/Details/C2017B00161/Html/Text
  49. Jacobs B (2 August 2017) Donald Trump proposes law to cut immigration numbers by half in 10 years. The Guardian. http://www.theguardian.com/us-news/2017/aug/02/trump-immigration-law-reduction-10-years
  50. Jalloh v Germany (Application 54810/00) [2006] HUDOC (Grand Chamber, European Court of Human Rights)Google Scholar
  51. Jefferson T (2002) The Declaration of Independence. Scholastic IncGoogle Scholar
  52. Karovska-Andonovska B (2014) Right to privacy in the constitutions of the European Countries and the US constitution. Vizione 22:127Google Scholar
  53. Kleinlein T (2012) Constitutionalization of international law. Das Max-Planck-Institut für ausländisches öffentliches Recht und Völkerrecht 231:703Google Scholar
  54. Koskenniemi M, Leino P (2002) Fragmentation of international law? Postmodern anxieties. Leiden J Int Law 15(3):553–579CrossRefGoogle Scholar
  55. Krajewska A (2012) International biomedical law in search for its normative status. Revista De Derecho Y Genoma Humano = Law and the Human Genome Review 36:121Google Scholar
  56. Lander ES et al (2019) Adopt a moratorium on heritable genome editing. Nature 567:165CrossRefGoogle Scholar
  57. Lee MYK (2008) Universal human dignity: some reflections in the Asian context. Asian J Comp Law 3:1CrossRefGoogle Scholar
  58. Lembaga Tatatertib Perkhidmatan Awam, Hospital Besar Pulau Pinang v Utra Badi A/L K Perumal (2000) Malayan Law J 3:281 (Kuala Lumpur Court of Appeal)Google Scholar
  59. Lie W (2004) Equality and non-discrimination under international human rights law. Research Notes, Norwegian Centre for Human Rights: University of OsloGoogle Scholar
  60. Ma Y, Zhao Y, Liao M (2015) The values demonstrated in the constitution of the People’s Republic of China. In: Ladikas M et al (eds) Science and technology governance and ethics. SpringerGoogle Scholar
  61. Macklin R (2003) Dignity is a useless concept. BMJ 327:1419CrossRefGoogle Scholar
  62. McCrudden C (2008) Human dignity and judicial interpretation of human rights. Eur J Int Law 19:655CrossRefGoogle Scholar
  63. Miller J (2014) The influence of human rights and basic rights in private law in the United States. Am J Comp Law 62:133CrossRefGoogle Scholar
  64. Ministry of Foreign Affairs of Denmark, Denmark for the UN Human Rights Council. http://um.dk/en/foreign-policy/denmark-for-the-un-human-rights-council/
  65. Mohamad Bin Senik v Public Prosecutor (2005) Malay Law J 4:164 (Kuala Lumpur Court of Appeal)Google Scholar
  66. Mutua M (2001) Savages, victims, and saviors: the metaphor of human rights. Harv Int Law J 42:201Google Scholar
  67. Nuffield Council on Bioethics (2016) Genome editing: an ethical review. Nuffield Council on BioethicsGoogle Scholar
  68. Nunan D, Di Domenico M (2017) Big data: a normal accident waiting to happen? J Bus Ethics 145:481CrossRefGoogle Scholar
  69. O’Mahony C (2012) There is no such thing as a right to dignity. Int J Const Law 10:551CrossRefGoogle Scholar
  70. Owigar JWB (2002) Ethics and living values in constitution. Const Kenya Rev Comm, 4. http://www.commonlii.org/ke/other/KECKRC/2002/4.html
  71. Powell T (20 December 2017) May Faces Brexit Grilling by Powerful Committee of MPs. Evening Standard. https://www.standard.co.uk/news/politics/brexit-latest-theresa-may-to-be-grilled-on-eu-withdrawal-negotiations-by-committee-of-powerful-mps-a3723596.html
  72. Pretty v the United Kingdom (Application No 2346/02) [2002] HUDOC (Fourth Section, European Court of Human Rights)Google Scholar
  73. Rantsev v Cyprus & Russia (Application No 25965/04) HUDOC (First Section, European Court of Human Rights)Google Scholar
  74. Rauch BJ et al (2017) Inhibition of CRISPR-Cas9 with bacteriophage proteins. Cell 168:150CrossRefGoogle Scholar
  75. Rawlinson MC, Donchin A (2005) The quest for universality: reflections on the universal draft declaration on bioethics and human rights. Dev World Bioeth 5:258CrossRefGoogle Scholar
  76. Reardon S (2015) Global summit reveals divergent views on human gene editing. Nature 528:173CrossRefGoogle Scholar
  77. Research and Library Division Department of Jurisconsult (2016) Bioethics and the Case-Law of the Court. Council of Europe / European Court of Human Rights, Research ReportGoogle Scholar
  78. Robinson M (2007) The value of a human rights perspective in health and foreign policy. Bull World Health Org 85:241CrossRefGoogle Scholar
  79. Rosen M (2012) Dignity: its history and meaning. Harvard University PressGoogle Scholar
  80. Ruiz-Chiriboga OR (2013) The American Convention and the protocol of San Salvador: two intertwined treaties-non-enforceability of economic, social and cultural rights in the Inter-American System. Neth Quart Human Rights 31:159CrossRefGoogle Scholar
  81. Schaefer GO (2 August 2016) The future of genetic enhancement is not in the west. The Conversation. http://theconversation.com/the-future-of-genetic-enhancement-is-not-in-the-west-63246
  82. Schwartz CM et al (2016) Synthetic RNA polymerase III Promoters facilitate high-efficiency CRISPR–Cas9-mediated genome editing in Yarrowia Lipolytica. ACS Synthetic Biol 5:356CrossRefGoogle Scholar
  83. Sharp T (12 June 2013) Right to privacy: constitutional rights & privacy laws. Live Science. https://www.livescience.com/37398-right-to-privacy.html
  84. Sholley JB (1951) Constitution of the United States of America. In: Cases on constitutional law. Bobbs-MerrillGoogle Scholar
  85. Siliadin v France (Application No 73316/01) [2005] HUDOC (Second Section, European Court of Human Rights)Google Scholar
  86. Stone G et al (2005) Constitutional law, 5th edn. Aspen PublishersGoogle Scholar
  87. Tan Tek Seng v Suruhanjaya Perkhidmatan Pendidikan & Anor (1996) Malay Law J 1:261 (Kuala Lumpur Court of Appeal)Google Scholar
  88. Taylor AL (2004) Governing the globalization of public health. J Law Med Ethics 32:500CrossRefGoogle Scholar
  89. Tisdall S (23 July 2017) Europe seeks a long-term answer to a refugee crisis that needs a solution now. The Observer. http://www.theguardian.com/world/2017/jul/22/divided-europe-refugee-crisis-italy-serbia-greece
  90. Travis J (4 December 2015) Inside the Summit on human gene editing: a reporter’s notebook. Science. http://www.sciencemag.org/news/2015/12/inside-summit-human-gene-editing-reporter-s-notebook
  91. Trstenjak V, Weingerl P (eds) (2016) The influence of human rights and basic rights in private law, vol 15. SpringerGoogle Scholar
  92. Turriziani JV (2014) Designer babies: the need for regulation on the quest for perfection. Law School Student Scholarship, 595. http://scholarship.shu.edu/cgi/viewcontent.cgi?article=1595&context=student_scholarship
  93. Tysiac v Poland (Application No 5410/03) [2007] HUDOC (Fourth Section, European Court of Human Rights)Google Scholar
  94. Uchiyama M, Nagai A, Muto K (2018) Survey on the perception of germline genome editing among the general public in Japan. J Human Genet 63:745CrossRefGoogle Scholar
  95. UNESCO (11 November 1997) Universal Declaration on the Human Genome and Human Rights. http://portal.unesco.org/en/ev.php-URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html
  96. UNESCO (16 October 2003) International Declaration on Human Genetic Data. http://unesdoc.unesco.org/images/0013/001361/136112e.pdf
  97. UNESCO (2006) The Universal Declaration on Bioethics and Human Rights. http://unesdoc.unesco.org/images/0014/001461/146180E.pdf
  98. UNESCO (5 October 2015) UNESCO Panel of Experts Calls for Ban on “Editing” of Human DNA to Avoid Unethical Tampering with Hereditary Traits. https://en.unesco.org/news/unesco-panel-experts-calls-ban-editing-human-dna-avoid-unethical-tampering-hereditary-traits
  99. United Nations General Assembly, Report of the Sixth Committee, ‘International Convention against the Reproductive Cloning of Human Beings (A/59/516/Add.1). https://digitallibrary.un.org/record/542699/files/A_59_516_Add.1-EN.pdf
  100. Wade N (21 December 2017) Scientists seek ban on method of editing the human genome. The New York Times. https://www.nytimes.com/2015/03/20/science/biologists-call-for-halt-to-gene-editing-technique-in-humans.html
  101. Wade N (19 January 2018) Scientists seek moratorium on edits to human genome that could be inherited. The New York Times. https://www.nytimes.com/2015/12/04/science/crispr-cas9-human-genome-editing-moratorium.html
  102. Warbrick C (1989) Federal aspects of the European Convention on Human Rights. Mich J Int Law 10:698Google Scholar
  103. Weisberg SM, Badgio D, Chatterjee A (2017) A CRISPR new world: attitudes in the public toward innovations in human genetic modification. Front Public Health 5Google Scholar
  104. Wilkie M. ‘Australian Bill of Rights Bill 2017 No., 2017’ 38Google Scholar
  105. World Health Organization, WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. https://www.who.int/ethics/topics/human-genome-editing/committee-members/en/
  106. World Medical Association (19 October 2013) WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

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Authors and Affiliations

  • Pin Lean Lau
    • 1
  1. 1.Central European UniversityBudapestHungary

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