Health Canada Has Broad Discretion in Reviewing Drug Submissions
Hospira Healthcare Corp. v. Canada (Attorney General), 2010 FC 213 (O’Keefe, J.)

February 25, 2010

Susan D. Beaubien for the Applicant, Hospira Healthcare Corp. (“Hospira”)
F. B. Woyiwada for the Respondent, Attorney General of Canada

Hospira brought an application under Section 18.1 of the Federal Courts Act for a judicial review of Health Canada’s decision to reject a New Drug Submission (“NDS”) filed by the applicant. The NDS was rejected because it did not comply with the requirements of Section C.08.002 of the Food and Drug Regulations (“Regulations”). The application was dismissed.

An NDS is required for the regulatory approval of a drug by Health Canada. Sections C.08.002(2)(g) and (h) of the Regulations require that an NDS include (i) detailed reports of the tests done to establish the safety of the new drug; and (ii) substantial evidence of clinical effectiveness. Hospira filed its NDS without any pre-clinical or clinical data, relying instead on the widespread use of its drug in Western countries to establish evidence of its safety and efficacy. Hospira’s view was that the published literature references and reports of post-marketing experience included in its NDS were sufficient to demonstrate safety and effectiveness and that Hospira had no need to perform any clinical testing of its own.

Health Canada’s view was that even though the words “clinical trial data” or “pre-clinical data” do not appear in Sections C.08.002(2)(g) and (h) of the Regulations, the sections implicitly require pre-clinical and clinical data. It also argued that even if the Minster of Health’s interpretation that pre-clinical and clinical data are required is unreasonable, the Regulations provide the Minister with the discretion to request that such data be provided with an NDS.

Justice O’Keefe agreed with Health Canada, observing that the plain words of the Regulations grant the Minister a considerable degree of flexibility in what he or she may accept as evidence of a new drug’s safety and effectiveness. The Minister’s decision was determined to be reasonable.

By: Asma Faizi, Torys LLP