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From sandbox to pandemic: Agile reform of Canadian drug regulation

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  • Eren Vural, Ipek
  • Herder, Matthew
  • Graham, Janice E.

Abstract

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Omnibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, however, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. In addition, Bill C-97 informed Canada's COVID-19 response in important ways, particularly in relation to clinical trials. The measures adopted by the drug regulatory authority, Health Canada (HC) during COVID-19 may become the new norm in Canadian regulatory practice insofar as they help achieve the amendments introduced by Bill C-97. Finally, despite government rhetoric of transparency, the agenda-setting, formulation, and implementation of the amendments have occurred with little opportunity for scrutiny or public engagement.

Suggested Citation

  • Eren Vural, Ipek & Herder, Matthew & Graham, Janice E., 2021. "From sandbox to pandemic: Agile reform of Canadian drug regulation," Health Policy, Elsevier, vol. 125(9), pages 1115-1120.
    • Handle: RePEc:eee:hepoli:v:125:y:2021:i:9:p:1115-1120
    DOI: 10.1016/j.healthpol.2021.04.018
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    References listed on IDEAS

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    1. Mavis Jones & Janice E Graham, 2009. "Multiple institutional rationalities in the regulation of health technologies: An ethnographic examination," Science and Public Policy, Oxford University Press, vol. 36(6), pages 445-455, July.
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    Cited by:

    1. Douglas, Conor M.W. & Grunebaum, Shir, 2024. "Lessons learned from the Canadian Fabry Disease Initiative for future risk-sharing and managed access agreements for pharmaceutical and advanced therapies in Canada," Health Policy, Elsevier, vol. 143(C).

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