Witness Testimony

Shawn Buckley, a lawyer with extensive experience in Food and Drugs Act litigation and regulatory matters, testified regarding changes to the drug approval framework used for COVID-19 vaccines in Canada. He outlined the standard “new drug” approval process under regulation C.08, which requires detailed evidence enabling the Minister to assess safety, clinical effectiveness, and whether benefits outweigh risks. He contrasted this with an interim order issued under section 31.1 of the Food and Drugs Act, which created a distinct authorization pathway for COVID-19 drugs.
Buckley argued that the interim order altered the legal test by requiring that the Minister “must issue” an authorization if sufficient evidence supports the conclusion that benefits outweigh risks, having regard to uncertainties and urgent public health needs. He emphasized that the interim language did not expressly require proof of safety or efficacy in the same manner as the standard regulations and allowed certain information to be provided after initial submission. He further testified that the interim order temporarily removed the Minister’s power to withdraw market authorization for COVID-19 drugs based on subsequent safety, efficacy, or fraud concerns.
He stated that, after one year, elements of the interim order were incorporated into the regular regulations, after which manufacturers reapplied for standard Drug Identification Numbers. Buckley characterized these legislative and administrative changes as indicative of a political rather than strictly health-based decision-making process. He also expressed broader concerns about the expansion of administrative authority, ministerial exemption powers, and the use of public messaging language describing vaccines as “proven safe and effective” in light of the modified regulatory framework.