From sandbox to pandemic: Agile reform of Canadian drug regulation

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.

The unintended consequences of COVID-19 vaccine policy: why mandates, passports and restrictions may cause more harm than good

“…Governments have refused to disclose the details of contracts with manufacturers, including for additional doses or ‘next-generation’ vaccines 99. Vaccines are typically not approved until 2 years of follow-up data are gathered,2 but given the urgency of the COVID-19 pandemic and international harmonisation of new agile regulations, the novel mRNA COVID-19 vaccines were placed into emergency use in Europe and North America in late 2020 128. There is concern that, in the fog of crisis, vaccine policy is being driven by vaccine manufacturers rather than independent scientific and regulatory review.…”

Quality and quantity of data used by Health Canada in approving new drugs

“…Health Canada maintains that agile regulation will continue to ensure authorized drugs are safe, effective, and subject to appropriate oversight ( 20 ), but in its 2018 Budget, the federal government was also promoting a regulatory reform agenda that would support innovation and business investments and would target regulatory requirements and practices that were bottlenecks to innovation and growth in Canada ( 13 ). Critics of agile regulation have charged that it would allow companies to bring drugs to market up to 6 months earlier than is currently allowed and that drug approvals would require fewer premarket clinical trials “as long as firms continue studying their drugs’ effectiveness after they are already in use” ( 16 ).…”

“…The break at the end of 2015 was based on a Health Products and Food Branch strategic plan for 2016–2021, which analyzed the evolving regulatory environment and outlined planned changes in four areas: openness and transparency, collaboration, the organization and people, and innovation ( 11 ). The second breakpoint at the end of 2018 was chosen because of the release of a draft guidance on the use of accelerated reviews of drug submissions ( 12 ) and the adoption of “agile regulation” by Health Canada in mid-2019 ( 13 ).…”

Introducing a Regulatory Sandbox Into the Indonesian Health System Using e-Malaria as a Use Case: Participatory Action Study

“…More than 50 countries, including Indonesia, have adopted this framework [ 1 ]. The COVID-19 pandemic has further underscored the importance of regulatory sandboxes, as evidenced by the use of emergency authorization for COVID-19 vaccines [ 2 , 3 ]. Although regulatory sandboxes have been used in a number of health sectors in high-income countries [ 4 , 5 ], their adoption remains very limited in low- and middle-income countries, including Indonesia.…”

“…This allows for the cautious relaxation of certain regulations to foster innovation, while ensuring that new technologies undergo validation before widespread implementation. Ultimately, regulatory sandboxes enable the scale-up of proven digital healthtech [ 3 , 4 ].…”