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Legal Governance of Genome-Editing Technologies for Human Gene and Cell Therapies in Singapore

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Rechtliche Aspekte der Genom-Editierung an der menschlichen Keimbahn

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Zusammenfassung

This chapter provides an analysis of the legal governance that applies to genome-editing technologies for human biomedical research and (somatic and germline) cell therapies in Singapore. Genome-editing technologies refer to a group of techniques that include CRISPR/Cas9, which is a technological tool by which gene locus can be altered to create a specific genetic modification at that precise locus. For the purposes of this chapter, reference to gene-editing technologies includes techniques that could modify the genetic composition of a human cell. The ability to apply such techniques to human somatic and germline cells can eventually offer therapeutic opportunities to treat severe hereditary diseases by repairing the disease-causing gene(s). With a few exceptions, gene-editing technologies remain technically challenging and complex to implement safely and effectively at the time of writing, mainly because of fundamental limitations in the ability to precisely control how genetic material can be altered or introduced into cells. In other words, safety continues to be the foremost of concerns if such technologies are to be administered as clinical practice. Apart from concerns about physical wellbeing, gene-editing technologies have also raised concerns that relate to eugenics as they can be applied for non-therapeutic purposes or otherwise for the purposes of genetic enhancement. This chapter discusses the legal responses in Singapore to these and related concerns as legal governance of an emergent biomedical technology. Legal governance refers not only to statutory laws and regulations, but also to ethical principles, recommendations and good practices that either have regulatory effect or represent the legal or regulatory ends of legal requirements that apply to the use of genome-editing technologies in Singapore.

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Notes

  1. 1.

    Yong Vui Kong v Attorney General [2011] SGCA 9.

  2. 2.

    Detailed provisions are set out under the Medicines (Clinical Trials) Regulations 2016, available via https://sso.agc.gov.sg/SL/MA1975-S335-2016?DocDate=20160715&ProvIds=P12-#pr13-. Accessed 19 Feb 2019.

  3. 3.

    Private Hospitals and Medical Clinics Act, Cap 248, 1999 Rev Ed; and Medical Registration Act, Cap 174, 2004 Rev Ed.

  4. 4.

    National Medical Ethics Committee, Ethical Guidelines on Research Involving Human Subjects. Singapore: Ministry of Health, August 1997.

  5. 5.

    Bioethics Advisory Committee, Research Involving Human Subjects: Guidelines for IRBs. Singapore: Bioethics Advisory Committee, November 2004.

  6. 6.

    Ibid, at 41, paragraph 5.20.

  7. 7.

    Ministry of Health, Directive 1A/2006: BAC Recommendations for Biomedical Research, 18 January 2006.

  8. 8.

    Ministry of Health, Operational Guidelines for Institutional Review Boards. Singapore: Ministry of Health (Biomedical Research Regulation Division), December 2007, at 8–9, paragraphs 7.10.5, 7.12, Sect. 10.

  9. 9.

    Statute available via: https://sso.agc.gov.sg/Act/HBRA2015. Accessed 19 Feb 2019.

  10. 10.

    The Regulation of Biomedical Research Bill, 2003. Public consultation was conducted on this document, but it was never presented in Parliament.

  11. 11.

    Human Biomedical Research Act 2015. Section 3(3) identifies these materials as human gametes or human embryos, cytoplasmic hybrid embryos, human-animal combination embryo and human stem cells or neural cells.

  12. 12.

    Ibid, Section 3(2)(a)–(c).

  13. 13.

    Ibid, Section 3(2)(i)–(iii).

  14. 14.

    Other research excluded from the statutory definition of human biomedical research include minimal risk studies and tests that relate to normal human psychological responses and behaviours or measurement of human intelligence, as well as activities that are already governed under a different statutory regime. Ibid, Schedule 2, paragraphs 1, 2, 6 and 7.

  15. 15.

    Ibid, Section 3(5).

  16. 16.

    Bioethics Advisory Committee, Ethics Guidelines for Human Biomedical Research. Singapore: Bioethics Advisory Committee, 2015.

  17. 17.

    Ibid, Section 2.11, at 18.

  18. 18.

    As the BAC explains, the principle of beneficence is not considered to be distinct from the principle of respect for persons for many research endeavours, and is hence not set apart as a standalone principle. Ibid, Section 2.13, at 18.

  19. 19.

    Human Biomedical Research Regulation 2017, available via https://sso.agc.gov.sg/SL/HBRA2015-S621-2017?DocDate=20171030. Accessed 19 Feb 2019.

  20. 20.

    Human Biomedical Research Act 2015, Section 6.

  21. 21.

    Ibid, Sections 7 and 8.

  22. 22.

    Ibid, Section 12(1).

  23. 23.

    Ibid, Section 26.

  24. 24.

    Ibid, Sections 27, 28 and 29.

  25. 25.

    Ibid, Section 2.

  26. 26.

    Ministry of Health. 2014. Human Biomedical Research Bill: Public Consultation Nov-Dec 2014. Available via https://www.moh.gov.sg/home. Accessed 19 Feb 2019.

  27. 27.

    Human Biomedical Research Act 2015, Section 32.

  28. 28.

    Ibid, Section 33.

  29. 29.

    Ibid, Section 38.

  30. 30.

    Ibid, Section 2.

  31. 31.

    Ibid, Section 6.

  32. 32.

    Ibid, Section 9.

  33. 33.

    Ibid, Section 10.

  34. 34.

    Ibid, Section 11.

  35. 35.

    Ibid, Section 12(2).

  36. 36.

    Bioethics Advisory Committee, Human Tissue Research. Singapore: Bioethics Advisory Committee 2002, paragraph 9.6.

  37. 37.

    Human Biomedical Research Act 2015.

  38. 38.

    Academy of Medical Sciences, Animals Containing Human Material. London: Academy of Medical Sciences, 2011, at 50.

  39. 39.

    Ibid, at 49.

  40. 40.

    Human Biomedical Research Act 2015, Section 31.

  41. 41.

    Human Biomedical Research (Restricted Research) Regulations 2017, S 622/2017, Section 3(2).

  42. 42.

    Available via https://www.moh.gov.sg/docs/librariesprovider5/legislation/guide-to-tiaras%2D%2D-updated.pdf. Accessed 22 Feb 2019.

  43. 43.

    Human Biomedical Research (Restricted Research) Regulations 2017, S 622/2017, Sections 6, 7 and 8.

  44. 44.

    Ibid, Section 5.

  45. 45.

    Ibid, Section 31(1).

  46. 46.

    International Society for Stem Cell Research, Guidelines for Stem Cell Research and Clinical Translation, 2016. Available via: http://www.isscr.org/docs/default-source/all-isscr-guidelines/guidelines-2016/isscr-guidelines-for-stem-cell-research-and-clinical-translation.pdf?sfvrsn=4. Accessed 19 Feb 2019.

  47. 47.

    Ministry of Health, Licensing Terms and Conditions for Assisted Reproduction Centres, 2011, paragraphs 9.1 and 10.3. The role of the MOH under this regime is likely to be similar to the UK Human Fertilisation and Embryology Authority. Whether this mechanism should be consolidated with the newly established regime under the HBRA is an open question at the time of writing.

  48. 48.

    Human Biomedical Research Act 2015, Section 31(2)(c). Restricted human biomedical research is to be reviewed by an IRB or “such other committee as may be prescribed, comprising members with certain specified qualifications.” Hence, at the minimum, restricted human biomedical research must be subject to review by an IRB (which may or may not be a stem cell specific IRB) and notice must also be provided to MOH.

  49. 49.

    Bioethics Advisory Committee, Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning. Singapore: Bioethics Advisory Committee, 2002.

  50. 50.

    Ho WLC, Capps B and Voo TC, Stem Cell Science and its Public: The Case of Singapore, East Asian Science, Technology and Society: An International Journal 4 (2010): 7–29.

  51. 51.

    Termination of Pregnancy Act, Cap 324, 1985 Rev Ed.

  52. 52.

    Kaan T, At the Beginning of Life, Singapore Academy of Law Journal 22 (2010): 883–918.

  53. 53.

    Bioethics Advisory Committee, Donation of Human Eggs for Research. Singapore: Bioethics Advisory Committee, 2008.

  54. 54.

    Bioethics Advisory Committee, Human-Animal Combinations in Stem Cell Research. Singapore: Bioethics Advisory Committee, 2010.

  55. 55.

    Human Biomedical Research (Restricted Research) Regulations 2017, S 622/2017, Sections 11 and 12.

  56. 56.

    Ibid, Section 13.

  57. 57.

    Ibid, Section 9.

  58. 58.

    Ibid, Section 10.

  59. 59.

    Ibid, Section 14.

  60. 60.

    Ibid, Section 15.

  61. 61.

    Bioethics Advisory Committee, Ethical Guidelines for Human Biomedical Research. Singapore: Bioethics Advisory Committee, 2015, at 56, paragraph 7.22.

  62. 62.

    Ibid, at 57. These considerations have been drawn from Mark Greene, et al. Moral Issues of Human-Non-Human Primate Neural Grafting, Science (2005) 309: 385–386.

  63. 63.

    Ibid, at 57, paragraph 7.24.

  64. 64.

    Ibid, at 59, paragraph 7.31.

  65. 65.

    Bioethics Advisory Committee, Genetic Testing and Genetic Research. Singapore: Bioethics Advisory Committee, 2005.

  66. 66.

    Ministry of Health, Licensing Terms and Conditions for Assisted Reproduction Centres, 2011.

  67. 67.

    Ibid, paragraph 9.1, at 27.

  68. 68.

    Ibid, paragraph 9.9, at 28–29.

  69. 69.

    Ibid, paragraph 9.10, at 29.

  70. 70.

    Ibid, paragraph 9.11, at 29.

  71. 71.

    Bioethics Advisory Committee, Genetic Testing and Genetic Research. Singapore: Bioethics Advisory Committee, 2005, paragraphs 4.51 and 4.52, and Recommendation 12, at 37 and 38.

  72. 72.

    Bioethics Advisory Committee, Ethical Guidelines for Human Biomedical Research. Singapore: Bioethics Advisory Committee, 2015, paragraph 6.4, at 49–50.

  73. 73.

    Ibid, paragraph 6.5, at 50.

  74. 74.

    Medicines Act, 1985 Rev. Ed., Section 3.

  75. 75.

    Available via https://sso.agc.gov.sg/Act/MA1975. Accessed 08 Jan 2019.

  76. 76.

    Medicines (Clinical Trials) Regulations 2016, available via: https://sso.agc.gov.sg/SL/MA1975-S335-2016?DocDate=20160715. Accessed 19 Feb 2019.

  77. 77.

    Available via: https://sso.agc.gov.sg/SL/MA1975-S336-2016?DocDate=20160715. Accessed 19 Feb 2019.

  78. 78.

    Regulatory guidance is available via: http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Clinical_Trials/Overview/Regulatory_Guidelines.html. Accessed 19 Feb 2019.

  79. 79.

    Health Sciences Authority, Regulatory Guidance: Safeguards and Consent Requirements in Vulnerable Subjects, 2 May 2017. Available via: http://www.hsa.gov.sg/content/dam/HSA/HPRG/Clinical_Trials/Guidance/HSA_CTB_Guidance_Vulnerable_Subjects_2May2017.pdf. Accessed 19 Feb 2019.

  80. 80.

    Available via: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html#6-2. Accessed 19 Feb 2019.

  81. 81.

    Please see: http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Clinical_Trials/Overview/Regulatory_Framework.html. Accessed 19 Feb 2019.

  82. 82.

    Please see: http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Useful_Information_for_Applicants/Target_Processing_Timelines.html. Accessed 19 Feb 2019.

  83. 83.

    Health Sciences Authority, Regulatory Guidance: Clinical Trials Guidance – Regulatory Requirements for New Applications and Subsequent Submissions, 2 May 2017. Available via: http://www.hsa.gov.sg/content/dam/HSA/HPRG/Clinical_Trials/Guidance/HSA_CTB_Guidance_New_and_Subsequent_Applications_2May2017.pdf. Accessed 19 Feb 2019.

  84. 84.

    Human Biomedical Research Act 2015, Section 31(4).

  85. 85.

    Bioethics Advisory Committee, Genetic Testing and Genetic Research. Singapore: Bioethics Advisory Committee, 2005, Recommendation 10, at 36.

  86. 86.

    Ibid, paragraphs 4.44–4.46, at 34–35.

  87. 87.

    Ministry of Health, Licensing Terms and Conditions for Assisted Reproduction Centres, 2011, at 9, 13 and 14.

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  1. Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore

    Calvin W. L. Ho

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Correspondence to Calvin W. L. Ho .

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  1. Institut für Medizinrecht, Universität Mannheim, Mannheim, Germany

    Jochen Taupitz

  2. Institut für Medizinrecht, Universität Mannheim, Mannheim, Germany

    Silvia Deuring

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Ho, C.W.L. (2020). Legal Governance of Genome-Editing Technologies for Human Gene and Cell Therapies in Singapore. In: Taupitz, J., Deuring, S. (eds) Rechtliche Aspekte der Genom-Editierung an der menschlichen Keimbahn . Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim, vol 47. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-59028-7_17

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