| Citation: |
Hospira Healthcare Corporation v. Canada (Attorney General), 2010 FCA 345, [2011] 2 F.C.R. D-3 |
A-126-10 |
Food and Drugs
Appeal from Federal Court judgment (2010 FC 213) dismissing judicial review of decision by Minister of Health (Minister) rejecting appellant’s new drug submission (NDS) at screening stage—In rejecting NDS, not clear whether Minister interpreting Food and Drug Regulations, C.R.C., c. 870, ss. C.08.002(2)(g),(h) as precluding issuance of notice of compliance in response to NDS not supported by data from clinical trials performed by or on behalf of party seeking notice of compliance (i.e. appellant)—Minister having discretion as to nature, form of information accepted as meeting requirements of ss. C.08.002(2)(g),(h), including reports of clinical trials conducted by others—However, safety, efficacy of drug cannot be established solely on basis that use permitted under Special Access Programme, even if permission given many times—Ss. C.08.002(2)(g),(h) not requiring Minister to reject NDS at screening stage on basis that Minister having no discretion to accept NDS without data from clinical trials conducted by appellant—Minister’s decision ambiguous as to why NDS rejected—In light of ambiguity of Minister’s reasons, appellant entitled to succeed—Appeal allowed.
Hospira Healthcare Corporation v. Canada (Attorney General) (A-126-10, 2010 FCA 345, Sharlow J.A., judgment dated December 14, 2010, 4 pp.)