| CITATION: |
hospira healthcare corporation v. canada (attorney general), 2010 FC 213, [2010] 2 F.C.R. D-2 |
T-116-07 |
Food and Drugs
Judicial Review of Health Canada Therapeutic Products Directorate’s decision rejecting new drug submission on basis no pre‑clinical, clinical trial data submitted pursuant to Food and Drug Regulations, C.R.C., c. 870, s. C.08.002—Minister’s view pre-clinical, clinical data implicitly required by Regulations, s. C.08.002 reasonable, falling within range of acceptable outcomes —Minister’s view strengthened by fact legislator specifying information must be sufficient to allow Minister to assess safety, efficacy—Even if that interpretation unreasonable, Minister not fettering discretion by requiring clinical data in all cases as matter of policy—Applicant’s particular circumstances considered extensively before policy applied—Also no breach in procedural fairness because requiring clinical data Health Canada’s normal procedure, applicant given explicit, sufficient notice clinical data would be required—Application dismissed.
Hospira Healthcare Corporation v. Canada (Attorney General) (T-116-07, 2010 FC 213, O’Keefe J., judgment dated February 25, 2010, 23 pp.)