We use cookies to improve your experience. By continuing to browse this site, you accept our cookie policy.×
Skip main navigation
Aging Health
Bioelectronics in Medicine
Biomarkers in Medicine
Breast Cancer Management
CNS Oncology
Colorectal Cancer
Concussion
Epigenomics
Future Cardiology
Future Medicine AI
Future Microbiology
Future Neurology
Future Oncology
Future Rare Diseases
Future Virology
Hepatic Oncology
HIV Therapy
Immunotherapy
International Journal of Endocrine Oncology
International Journal of Hematologic Oncology
Journal of 3D Printing in Medicine
Lung Cancer Management
Melanoma Management
Nanomedicine
Neurodegenerative Disease Management
Pain Management
Pediatric Health
Personalized Medicine
Pharmacogenomics
Regenerative Medicine

Creative regulatory practices to develop stem-cell technology: the way forward for Malaysia

    Mohammad Firdaus Bin Abdul Aziz

    *Author for correspondence:

    E-mail Address: firdausaziz@um.edu.my

    Centre for Law and Ethics in Science and Technology (CELEST), Faculty of Law, Universiti Malaya, Kuala Lumpur, Malaysia

    Centre for Health, Law and Ethics of Emerging Technologies (HeLEX), Faculty of Law, University of Oxford, Oxford, UK

    ,
    Michael Morrison

    Centre for Health, Law and Ethics of Emerging Technologies (HeLEX), Faculty of Law, University of Oxford, Oxford, UK

    &
    Jane Kaye

    Centre for Health, Law and Ethics of Emerging Technologies (HeLEX), Faculty of Law, University of Oxford, Oxford, UK

    Published Online:https://doi.org/10.2217/rme-2021-0068

    Malaysia aspires to develop regenerative medicine through stem-cell technology. It needs a regulatory system that could facilitate development and prevent unethical practices. A comparative legal analysis on the regulation of stem-cell technology, with a focus on stem-cell research in Malaysia and selected Commonwealth countries that are experienced in regulating this complex technology, demonstrates that the selected Commonwealth countries have adopted a hybrid of different regulatory mechanisms. This paper argues that Malaysia should consider adopting a similar approach to equip relevant authorities with different regulatory mechanisms that are able to promote innovation in stem-cell research activities and cultivate a successful and profitable regenerative medicine industry in the future. Such a strategic action can produce an optimal regulatory outcome and help Malaysia to realize its aspiration.

    Papers of special note have been highlighted as: • of interest; •• of considerable interest

    References

    • 1. Academy of Sciences Malaysia. Advisory report on stem cells ageing and regenerative medicine (2013). https://www.akademisains.gov.my/asm-publication/stem-cells-medicine/
    • 2. Salter B. State strategies and the geopolitics of the global knowledge economy: China, India and the case of regenerative medicine. Geopolitics 14(1), 47–78 (2009). • Examines the global competition between emerging jurisdictions in the stem-cell race.
    • 3. Hogarth S, Salter B. Regenerative medicine in Europe: global competition and innovation governance. Reg. Med. 5(6), 971–985 (2010).
    • 4. Salter B, Salter C. Governing innovation in the biomedicine knowledge economy: stem cell science in the USA. Sci. Public Policy 37(2), 87–100 (2010).
    • 5. Chen H. Reflection on the governance of clinical stem cell research and applications in China. Reg. Med. 12(6), 593–597 (2017).
    • 6. Lysaght T. Accelerating regenerative medicine: the Japanese experiment in ethics and regulation. Reg. Med. 12(6), 657–668 (2017). • Further provides an analysis on the global competition, which has resulted in an expedited pathway to promote regenerative medicine.
    • 7. The Rt Hon David Willetts’ speech. Eight Great Technologies.(2013). https://www.gov.uk/government/speeches/eight-great-technologies
    • 8. Bin Abdul Aziz MF, Morrison M, Kaye J. Regulating human stem cell research and therapy in low-and middle-income countries: Malaysian perspectives. New Genet. Soc. 37(1), 2–20 (2018). •• Provides findings based on empirical interviews on how stakeholders perceive stem cell regulation in Malaysia and highlights the concerns shared among the stakeholders.
    • 9. Regulation for the Fourth Industrial Revolution: White Paper. HM Government, London, UK (2019). https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/807792/regulation-fourth-industrial-strategy-white-paper-web.pdf
    • 10. OECD. Public consultation on the draft OECD Recommendation for Agile Regulatory Governance to Harness Innovation (2021). https://www.oecd.org/mcm/Recommendation-for-Agile-Regulatory-Governance-to-Harness-Innovation.pdf
    • 11. Mclaren A. Where to draw the line. Presented at: The Royal Institution. UK, 56, 101–121 (1984).
    • 12. Lockwood M. When does a life Begin? Moral Dilemmas in Modern Medicine. M. Lockwood (Ed.). Oxford University Press, NY, USA (1995).
    • 13. Walters L. Ethics and new reproductive technologies: an international review of committee statements. Hastings Cent. Rep. 17(3), 3–9 (1987).
    • 14. Braude P, Johnson M. Embryo research: yes or no? BMJ 299(6712), 1349–1351 (1989).
    • 15. Ford NM. When did I begin?: Conception of the Human Individual in History, Philosophy and Science. Cambridge University Press, Cambridge, UK, (1991).
    • 16. Holland S, Lebacqz K, Zoloth L. The Human Embryonic Stem Cell Debate: Science, Ethics, and Public Policy. MIT Press, Cambridge, UK, (2001).
    • 17. Welin S. Ethical issues in human embryonic stem cell research. Acta Obstet. Gynecol. Scand. 81(5), 377–382 (2002).
    • 18. Knowles LP. Religion and stem cell research. Stem Cell Network. (2009). http://www.stemcellnetwork.ca/uploads/File/whitepapers/Religion-and-Stem-Cell-Research.pdf
    • 19. Caulfield T, Zarzeczny A, Mccormick J et al. The stem cell research environment: a patchwork of patchworks. Stem Cell Rev. Rep. 5(2), 82–88 (2009). •• Provides an examination on the different regulatory approaches at the global level and its influence in the development of stem-cell research.
    • 20. Eurobarometer. Special Eurobarometer: biotechnology (2010). https://europa.eu/eurobarometer/surveys/detail/755
    • 21. Zarzeczny A, Caulfield T. Emerging ethical, legal and social issues associated with stem cell research & and the current role of the moral status of the embryo. Stem Cell Rev. Rep. 5(2), 96–101 (2009).
    • 22. Kakuk P. The legacy of the Hwang case: research misconduct in biosciences. Sci. Eng. Ethics. 15(4), 545–562 (2009).
    • 23. Wade N, Sang-Hun C. Researcher faked evidence of human cloning, Koreans report. The New York Times (2006). https://www.nytimes.com/2006/01/10/science/10clone.html
    • 24. Gottweis H, Triendl R. South Korean policy failure and the Hwang debacle. Nat. Biotechnol. 24(2), 141–143 (2006). •• Addresses the scandal in the stem-cell arena and argues for the importance of good governance.
    • 25. Clay AS. South Korea’s bioethics and biosafety act (2005). Embryo Project Encyclopedia (2013). https://embryo.asu.edu/pages/south-koreas-bioethics-and-biosafety-act-2005
    • 26. Caulfield T, Rachul C, Zarzeczny A. The evolution of policy issues in stem cell research: an international survey. Stem Cell Rev. Rep. 8(4), 1037–1042 (2012).
    • 27. Colen BD. ‘Stem cell tourism’ growing trend (2015). http://news.harvard.edu/gazette/story/2012/11/the-rise-of-stem-cell-tourism/
    • 28. Einsiedel EF, Adamson H. Stem cell tourism and future stem cell tourists: policy and ethical implications. Dev World Bioeth. 12(1), 35–44 (2012).
    • 29. Master Z, Resnik DB. Stem-cell tourism and scientific responsibility. Embo. Rep. 12(10), 992–995 (2011).
    • 30. Peterson A, MacGregor C, Munsie M. Stem cell tourism exploits people by marketing hope (2015). http://theconversation.com/stem-cell-tourism-exploits-people-by-marketing-hope-29146
    • 31. Tenebaum T. ‘Stem cell tourism’ takes advantage of patients, says law professor (2015). http://news.wisc.edu/22660
    • 32. Lysaght T, Kerridge I, Sipp D, Porter G, Capps BJ. Oversight for clinical uses of autologous adult stem cells: lessons from international regulations. Cell Stem Cell. 13(6), 647–651 (2013).
    • 33. Mclean AK, Stewart C, Kerridge I. Untested, unproven, and unethical: the promotion and provision of autologous stem cell therapies in Australia. Stem Cell. Res. Ther. 6(1), 1–8 (2015).
    • 34. Berger I, Ahmad A, Bansal A, Kapoor T, Sipp D, Rasko JE. Global distribution of businesses marketing stem cell-based interventions. Cell Stem Cell. 19(2), 158–162 (2016).
    • 35. Erikainen S, Couturier A, Chan S. Marketing experimental stem cell therapies in the uk: biomedical lifestyle products and the promise of regenerative medicine in the digital era. Sci. Cult. (Lond.) 29(2), 219–244 (2020).
    • 36. Fujita M, Hatta T, Ozeki R, Akabayashi A. The current status of clinics providing private practice cell therapy in Japan. Regen. Med. 11(1), 23–32 (2016).
    • 37. Turner L, Knoepfler P. Selling stem cells in the USA: assessing the direct-to-consumer industry. Cell Stem Cell. 19(2), 154–157 (2016).
    • 38. Master Z, Resnik DB. Stem-cell tourism and scientific responsibility: stem-cell researchers are in a unique position to curb the problem of stem-cell tourism. Embo. Rep. 12(10), 992–995 (2011).
    • 39. Petersen A, Munsie M, Tanner C, Macgregor C, Brophy J. Stem Cell Tourism and the Political Economy of Hope: Health, Technology & Society. Palgrave Macmillan, London, UK (2017).
    • 40. Faulkner A, Geesink I, Kent J, Fitzpatrick D. Human tissue engineered products – drugs or devices?: Tackling the regulatory vacuum. BMJ-BRIT MED J. 326(7400), 1159 (2003).
    • 41. Kiatpongsan S, Sipp D. Monitoring and regulating offshore stem cell clinics. Science 323(5921), 1564–1565 (2009).
    • 42. Mertes H, Pennings G. Oocyte donation for stem cell research. Hum. Reprod. 22(3), 629–634 (2007).
    • 43. Salter B. Governing stem cell science in China and India: emerging economies and the global politics of innovation. New Genet. Soc. 27(2), 145–159 (2008).
    • 44. Salter B, Cooper M, Dickins A, Cardo V. Stem cell science in India: emerging economies and the politics of globalization. Regen. Med. 2, 75–89 (2007).
    • 45. Webster A, Eriksson L. Governance-by-standards in the field of stem cells: managing uncertainty in the world of “basic innovation”. New Genet. Soc. 27(2), 99–111 (2008).
    • 46. Sithole S. Stem cell research-the regulatory framework in South Africa: forum. S. Afr. J. Bioeth. Law. 4(2), 55–57 (2011).
    • 47. Baldwin R. Regulation: after command and control. In: The Human Face of Law: Essays in Honour of Donald Harris. Hawkins KHarris D (Eds). Clarendon Press, Oxford, UK, xvi–299 (1997).
    • 48. Gunningham N, Grabosky P. Smart Regulation. Clarendon Press, Oxford, UK (1998).
    • 49. Hood C, Rothstein H, Baldwin R. The Government of Risk: Understanding Risk Regulation Regimes. Oxford University Press, Oxford, UK (2001).
    • 50. Morgan B, Yeung K. An Introduction to Law and Regulation: Text and Materials. Cambridge University Press, Cambridge, UK (2007).
    • 51. Baldwin R, Cave M, Lodge M. Understanding Regulation: Theory, Strategy, and Practice, (2nd Edition). Oxford University Press, Oxford, UK, 106 (2012). •• Provides a detailed analysis of the different types of regulatory techniques and compliance strategies.
    • 52. Ayres I, Braithwaite J. Responsive Regulation: Transcending the Deregulation Debate. Oxford University Press, Oxford, UK (1992).
    • 53. Isasi RM, Knoppers BM. Beyond the permissibility of embryonic and stem cell research: substantive requirements and procedural safeguards. Hum. Reprod. 21(10), 2474–2481 (2006).
    • 54. Murray A, Scott C. Controlling the new media: hybrid responses to new forms of power. Mod. 65(4), 491–516 (2002).
    • 55. Hutter BM. Compliance: Regulation and Environment. Clarendon Press, Oxford, UK (1997).
    • 56. Braithwaite J. Enforced self-regulation: a new strategy for corporate crime control. Mich. Law Rev. 80 (7 )1466–1507 (1982).
    • 57. Ayres I, Braithwaite J. Responsive Regulation: Transcending the Deregulation Debate. Oxford University Press, Oxford, UK (1992).
    • 58. Schnieke A, Mcshir J, Kind A, Campbell K, Wilmut I. Viable offspring derived from fetal and adult mammalian cells. Am. J. Ophthalmol. 2(124), 276 (1997).
    • 59. Thomson JA, Itskovitz-Eldor J, Shapiro SS et al. Embryonic stem cell lines derived from human blastocysts. Science 282(5391), 1145–1147 (1998).
    • 60. Morgan R. A tight fit? Deficiencies in the human fertilisation and embryology (research purposes) regulations 2001. Statut. 28(3), 199–217 (2007).
    • 61. UK, Human Fertilisation and Embryology (Research Purposes) Regulations 2001. HM Government, London, UK. (2001). https://www.legislation.gov.uk/uksi/2001/188/contents/made
    • 62. UK, Chief Medical Officer’s Expert Group ‘Stem Cell Research: Medical Progress with Responsibility’. HM Government, London, UK (2000). http://www.doh.gov.uk/cegc/stemcellreport.htm
    • 63. Mintrom M. Policy entrepreneurs and controversial science: governing human embryonic stem cell research. J. Eur. Public Policy 20(3), 442–457 (2013).
    • 64. Australia, NHMRC Embryo Research Licensing Committee – Information Kit. NHMRC, Canberra, Australia (2018). https://www.nhmrc.gov.au/about-us/publications/embryo-research-licensing-committee-information-kit
    • 65. ASSCR. Australia, The Australasian Society for Stem Cell Research (2014). http://www.asscr.org/about-us/about-us/
    • 66. Tanner C, Woodward-Kron R, Stewart C, Munsie M. Selling stem cells in Australia: assessing the impact of new advertising standards on business practices. Cytotherapy. 21(5), S22 (2019).
    • 67. Notebook P. How young Korean researchers helped unearth a scandal…. (2006). https://library.wur.nl/WebQuery/file/cogem/cogem_t4513d647_001.pdf
    • 68. Resnik DB, Shamoo AE, Krimsky S. Commentary: fraudulent human embryonic stem cell research in South Korea: lessons learned. Account. Res. 13(1), 101–109 (2006).
    • 69. Jhalani M. Protecting egg donors and human embryos-the failure of the South Korean Bioethics and Biosafety Act. Pac. Rim L. & Pol’y J. 17, 707 (2008).
    • 70. Mandel GN. Regulating emerging technologies. Law Innov. Technol. 1(1), 75–92 (2009). •• Offers a helpful overview of how regulation can be flexible to deal with the risks and benefits of emerging technologies.
    • 71. Brownsword R, Somsen H. Law, innovation and technology: before we fast forward – a forum for debate. Law Innov. Technol. 1(1), 1–73 (2009). •• Provides a helpful overview of the interplay between the role of law and technological innovation.
    • 72. Source: BSI. New guide to help UK to be global leader in stem cell research. Press release: https://www.bsigroup.com/en-GB/about-bsi/media-centre/press-releases/2006/11/New-guide-to-help-UK-to-be-Global-leader-in-stem-cell-research/
    • 73. Bernama. Malaysia ranks top 5 globally in mobile social media penetration, highest in region. New Straits Times (2019). https://www.bernama.com/en/news.php?id=1690477
    • 74. Kepios. Digital 2020: Malaysia. https://datareportal.com/reports/digital-2020-malaysia
    • 75. Digital Influence Lab. Malaysia Digital Marketing Statistics (2020). https://digitalinfluencelab.com/malaysia-digital-marketing-stats/