From sandbox to pandemic: Agile reform of Canadian drug regulation

Eren Vural İ., Herder M., Graham J. E.

Health Policy, vol.125, no.9, pp.1115-1120, 2021 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 125 Issue: 9
  • Publication Date: 2021
  • Doi Number: 10.1016/j.healthpol.2021.04.018
  • Journal Name: Health Policy
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Social Sciences Citation Index (SSCI), Scopus, ASSIA, International Bibliography of Social Sciences, PASCAL, Periodicals Index Online, Business Source Elite, Business Source Premier, CAB Abstracts, CINAHL, EMBASE, MEDLINE, PAIS International, Public Affairs Index, Veterinary Science Database
  • Page Numbers: pp.1115-1120
  • Keywords: Regulatory modernization, Health Canada, Biotechnology, Transparency, Stakeholder participation, Advanced therapeutic products
  • Middle East Technical University Affiliated: No


© 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.