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Transitioning Up to Best Practice, or Down to the Bare Minimum? Global Harmonisation of Regulation of Therapeutic Goods

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Globalisation in Transition

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Abstract

The COVID-19 pandemic has highlighted legal and ethical tensions within global markets for medical devices and pharmaceuticals. The global medical market is highly profitable, socially important, and tightly but inconsistently regulated. That regulation is ostensibly predicated on reducing risks to consumers by excluding unsafe therapeutic goods. Historically, market regulation has occurred nationally, with limited cross-recognition of approvals from other jurisdictions, reflecting the gravity of the state’s role in protecting its citizens and fostering local manufacturing. It is a persuasive rationale for the existence of the State. Globalisation of medical markets has prompted increased efforts at international harmonisation of those markets in line with neoliberal understandings of economies and the state. Standardisation of regulatory requirements across jurisdictions lowers compliance costs through reduced duplication of effort, incentivising investment in further research and development. However, there are risks associated with moving towards a globally harmonised regulatory framework, particularly if the threshold for an emerging single market is biased towards corporate stakeholders and provides inadequate protection to consumers from harms posed by therapeutic goods. This chapter examines whether protecting consumer safety remains the objective of a globally harmonised regulatory standard, or whether hegemonic market values have eroded the public harm minimisation foundations on which drug and device regulation are built.

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Notes

  1. 1.

    Farrar (2010), Farrar and Parsons (2012, 2013), Farrar (2019), 11, Farrar and Mayes (2013), Ariff et al. (2012).

  2. 2.

    Braithwaite, and Drahos (2000), 388. See also Drahos (2004), Yu (2013); Dutfield, and Suthersanen (2005).

  3. 3.

    Fidler (2020), Miller (2021), Kickbusch and Anna (2021).

  4. 4.

    Levi‐Faur (2013).

  5. 5.

    Wijesinghe et al. (2022), Gostin (2021). See more broadly Mitchell et al. (2010).

  6. 6.

    Drahos (1995), Drahos and John (2004), Maisonrouge (1981).

  7. 7.

    Evaluation of those models is hindered by the opacity of many of the deals between rights holders and national governments. See for example Sciacchitano and Armando (2021).

  8. 8.

    Moon and Kickbusch (2021), Labonté et al. (2021).

  9. 9.

    Mirchandani (2020).

  10. 10.

    World Health Organisation (2021). See also Wouters et al. (2021), Phelan et al. (2020).

  11. 11.

    McMahon (2021), Stephenson (2021).

  12. 12.

    For a perspective see Mirowski (2013).

  13. 13.

    Ritchie et al. (2020).

  14. 14.

    Eccleston‐Turner and Upton (2021), Stein (2021).

  15. 15.

    Achieving 70% COVID-19 Immunization Coverage by Mid-2022: Statement of the Independent Allocation of Vaccines Group (IAVG) of COVAX. 2021. https://www.who.int/news/item/23-12-2021-achieving-70-covid-19-immunization-coverage-by-mid-2022.

  16. 16.

    Berkley (2020).

  17. 17.

    Ibid.

  18. 18.

    See n 10 above.

  19. 19.

    The Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19: Communication from India and South Africa. 2020. WTO DOC. IP/C/W/669. file:///C:/Users/taris/Downloads/W669.pdf.

  20. 20.

    Zaman (2022).

  21. 21.

    Term coined by Hancher and Moran in their seminal ‘Mapping the regulatory Space’. Although whether pharmaceutical and medical device regulation, occupy a single ‘space’ encompassing multiple issues, or multiple spaces each containing single issues, is unclear from the literature, which seems to use both models. See Hancher and Michael (1998), Braithwaite et al. (2007).

  22. 22.

    Black (2001), Kingsford Smith (2002), Koop and Lodge (2017).

  23. 23.

    Levi‐Faur (2013).

  24. 24.

    Wells and Ahmed (2007), Levi-Faur (2009), Maynard and Bloor (2015).

  25. 25.

    Gamble (2014), Hartwick and Peet (2003), Slaughter (2009).

  26. 26.

    Gunningham (2015).

  27. 27.

    Slaughter (2000).

  28. 28.

    The differentiation between ‘safe’ and ‘effective’ is pertinent given that therapeutic goods regulators such as Australia’s Therapeutic Goods Administration (TGA), counterpart of the U.S. Food & Drugs Administration, focuses on the exclusion of harmful goods rather than promoting those that are effective. Regulation in Australia accordingly enables the marketing of homeopathic and other products that at best serve as placebos.

  29. 29.

    See Tobin (2012), Backman et al. (2008).

  30. 30.

    Vogel (1998). The paradigmatic safety event is Thalidomide, discussed in Carpenter (2014). See also Sonia and Chakraborty (2019).

  31. 31.

    Vergara et al. (2021), Ozawa and Stack (2013).

  32. 32.

    Sell (2007), Yu (2021), El Said (2022).

  33. 33.

    Kruk et al. (2018).

  34. 34.

    llingworth (2020), McBride et al. (2019). See also Rimmer (2021).

  35. 35.

    Statista. Pharmaceutical Products and Markets. https://www.statista.com/markets/412/topic/456/pharmaceutical-products-market/

  36. 36.

    Statista, Medical technology industry- Statistics and Facts. https://www.statista.com/topics/1702/medical-technology-industry/#dossierSummary__chapter3

  37. 37.

    Morgan et al. (2011), Avorn (2015), DiMasi and Grabowski (2021), Light and Warburton (2011).

  38. 38.

    See for example Zolgensma, a gene-based drug used to treat spinal muscular atrophy, which cost USD 2,124 million per patient when approved by the FDA: Stein, Rob. 2019 ‘At $2.1 Million, New Gene Therapy Is the Most Expensive Drug Ever. NPR. https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever: See also DiMasi et al. (2003), Eisenberg (2003).

  39. 39.

    World Health Organisation (2017).

  40. 40.

    Rimmer (2020), Kelsey (2019a, b).

  41. 41.

    Sciacchitano and Bartolazzi (2021).

  42. 42.

    Paradise (2020), Kapczynski (2021), Padmanabhan (2021).

  43. 43.

    Breyer (1998).

  44. 44.

    Dutfield (2021).

  45. 45.

    See e.g., Rizvi (2021), Stevis-Gridneff et al. (2021).

  46. 46.

    As distinct from having the best insight into the way their illness or condition, and any treatments, affect them individually.

  47. 47.

    Drahos and Braithwaite (2004), Alford (1996). See also Laffont and Tirole (1991).

  48. 48.

    Governments have typically not expressly referred to defence alignments or the importance of avoiding trade sanctions against politically powerful sectors such as farming as being determinative of policy that reflects the interest of hegemonic partners in making a ‘world safe for Big Pharma’. See however Kelsey (2019a, b), 11.

  49. 49.

    Weissman (2004).

  50. 50.

    Drahos et al. (2004), Baird (2013).

  51. 51.

    Sundaram (2015), Cockburn and Long (2015).

  52. 52.

    The framework thus features mechanisms such as Investor State Dispute Settlement provisions in free trade agreements that inhibit national initiatives that might disadvantage foreign investors through intervention based on public health, environmental or cultural protection. See Samples, Tim (2019), Hawkins and Holden (2016), Soudias (2021).

  53. 53.

    Sell (2003).

  54. 54.

    Ibid., 2.

  55. 55.

    Sell (2011), 91.

  56. 56.

    Ibid., 98.

  57. 57.

    Ibid., 101.

  58. 58.

    See e.g., Yamane, Hiroko. Interpreting TRIPS: Globalisation of Intellectual Property Rights and Access to Medicines (Hart, 2011), Ellen ‘t Hoen, ‘TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way from Seattle to Doha’ (2002) 3 Chicago Journal of International Law 27, 43, Sundaram, (2015) note 50.

  59. 59.

    Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994) (Hereon ‘TRIPS’) Article 27.2.

  60. 60.

    TRIPS Article 27.3a.

  61. 61.

    TRIPS Article 27.3b.

  62. 62.

    Abbott (2002), Murthy (2001), Sun (2004).

  63. 63.

    ‘t Hoen (2002).

  64. 64.

    Ibid.

  65. 65.

    Ibid.

  66. 66.

    Medicines Law and Policy Database TRIPS Flexibilities. http://tripsflexibilities.medicineslawandpolicy.org.

  67. 67.

    Urias and Ramani (2020).

  68. 68.

    Archibugi and Filippetti (2010).

  69. 69.

    Ibid., 146.

  70. 70.

    Ibid., 138.

  71. 71.

    Ibid., 143.

  72. 72.

    The ICH held its first meeting in 1990, attended by pharmaceutical regulators and industry stakeholders from the E.U., U.S., and Japan (https://www.ich.org/page/history). In 1992, medical device regulators and industry representatives from the U.S., E.U., Japan and Canada met to begin establishing the Global Harmonisation Task Force—subsequently redesignated the International Medical Device Regulators Forum—for the purpose of ‘achieving harmonisation in medical device regulatory practices’(https://www.imdrf.org/ghtf/organisational-structure).

  73. 73.

    National Academies of Sciences, Engineering, and Medicine (2020).

  74. 74.

    International Council for Harmonisation 30th Anniversary Publication—ICH—the global platform for harmonisation. 2021. https://www.ich.org/publication/ich-30th-anniversary-publication-ich-global-platform-harmonisation. See also Röttger-Wirtz (2021), Turner (2019).

  75. 75.

    Abraham and Davis (2020).

  76. 76.

    Ibid., 9.

  77. 77.

    See n 33 above. See also Cohen (2005); Pammolli et al. (2011); Gaudilliere (2021).

  78. 78.

    For example, in Australia some vaccines which have been approved by regulators in other countries are not approved for use in Australia and may not be recognised for the purposes of immigration: https://www.tga.gov.au/international-covid-19-vaccines-recognised-australia.

  79. 79.

    For example, many donated doses of vaccine have had impracticably short shelf-lives: https://www.who.int/news/item/29-11-2021-joint-statement-on-dose-donations-of-covid-19-vaccines-to-african-countries.

  80. 80.

    Stigler (1971).

  81. 81.

    It is difficult to think of a circumstance more consistent with the requirements legitimating compulsory licencing than those presently faced. Notwithstanding that, in a recent submission PhRMA—one of the most powerful pharmaceutical manufacturing lobby groups—expressed its outrage that compulsory licensing and waivers were being sought and considered. See PhRMA. 2022. Special 201 Submission 2022. https://www.phrma.org/resource-center/Topics/Intellectual-Property/PhRMA-Special-301-Submission-2022.

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Authors and Affiliations

  1. Faculty of Law, Bond University, Gold Coast, Australia

    Wendy Elizabeth Bonython

  2. Faculty of Business, Government and Law, University of Canberra, Canberra, Australia

    Bruce Baer Arnold

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  1. Wendy Elizabeth Bonython
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Correspondence to Wendy Elizabeth Bonython .

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  1. Bond University, Robina, QLD, Australia

    Umair Ghori

  2. Bond University, Robina, QLD, Australia

    Mary Hiscock

  3. Bond University, Robina, QLD, Australia

    Louise Parsons

  4. Bond University, Robina, QLD, Australia

    Casey Watters

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Bonython, W.E., Arnold, B.B. (2023). Transitioning Up to Best Practice, or Down to the Bare Minimum? Global Harmonisation of Regulation of Therapeutic Goods. In: Ghori, U., Hiscock, M., Parsons, L., Watters, C. (eds) Globalisation in Transition. Springer, Singapore. https://doi.org/10.1007/978-981-99-2439-4_5

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