From sandbox to pandemic: Agile reform of Canadian drug regulation

Date

2021-09-01

Author

Eren Vural, İpek
Herder, Matthew
Graham, Janice E.

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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

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© 2021Public 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.

Subject Keywords

Advanced therapeutic products, Biotechnology, Health Canada, Regulatory modernization, Stakeholder participation, Transparency

URI

https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85107830320&origin=inward
https://hdl.handle.net/11511/97628

Journal

Health Policy

DOI

https://doi.org/10.1016/j.healthpol.2021.04.018

Collections

Department of Political Science and Public Administration, Article

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Citation Formats

İ. Eren Vural, M. Herder, and J. E. Graham, “From sandbox to pandemic: Agile reform of Canadian drug regulation,” Health Policy, vol. 125, no. 9, pp. 1115–1120, 2021, Accessed: 00, 2022. [Online]. Available: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85107830320&origin=inward.