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 (Journal Indexed in SCI Expanded) identifier identifier

  • Publication Type: Article / Article
  • Volume: 125 Issue: 9
  • Publication Date: 2021
  • Doi Number: 10.1016/j.healthpol.2021.04.018
  • Title of Journal : Health Policy
  • Page Numbers: pp.1115-1120
  • Keywords: Advanced therapeutic products, Biotechnology, Health Canada, Regulatory modernization, Stakeholder participation, Transparency

Abstract

© 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.