Federal court | Industrial and Intellectual Property
PUBLIC HEALTH
Minister implemented import ban motivated by improper purpose
Main applicant was largest pharmaceutical manufacturer in Canada and it purchased and imported into Canada active pharmaceutical ingredients and finished dosage form pharmaceutical products from other applicants, affiliated Indian companies. United States Food and Drug Administration inspected Indian applicants’ facilities and found they were non-compliant with good manufacturing practices requirements and it issued import alert on all products coming from Indian applicants except for products that were medically necessary. Newspaper began publishing articles and editorials that were critical of Health Canada and respondent Minister of Health. Minister imposed import ban preventing importation of drug products into Canada from Indian applicants’ manufacturing facilities and it also amended main applicant’s establishment licences to prohibit import of all products except those deemed medically necessary. Applicants applied for judicial review. Application granted. Minister acted for improper purpose and did not act in accordance with duty of procedural fairness when import ban was implemented and establishment licences were amended. There was no evidence that minister was concerned with immediate health risks posed by products subject to ban or that situation was highly urgent such that level of procedural fairness should be less. Regulatory regime and circumstances suggested that procedural fairness should have been given prior to import ban being implemented. Minister failed to provide any notice and denied main applicant opportunity to be heard before unilaterally imposing import ban. Minister did not act in accordance with natural justice. Applicants had not met burden of proving that minister demonstrated reasonable apprehension of bias from lack of independence or impartiality. Minister’s actions were ultra vires. Minister used proper statutory provision to add terms and conditions to main applicant’s establishment licences but in circumstances provision should include procedural fairness granted to establishment licence holders throughout rest of regulatory scheme, which required notice and reasons for addition of terms and conditions. Section 2(e) of Canadian Bill of Rights did not apply in circumstances. As minister implemented import ban that was motivated by improper purpose and without providing main applicant with procedural protections required by law, decision was not reasonable or correct and it must be quashed. Minister acted without jurisdiction in releasing statements to media and statements were to be retracted.
Apotex Inc. v. Canada (Minister of Health) (Oct. 14, 2015, F.C., M.D. Manson J., File No. T-2223-14) 259 A.C.W.S. (3d) 580.
Minister implemented import ban motivated by improper purpose
Main applicant was largest pharmaceutical manufacturer in Canada and it purchased and imported into Canada active pharmaceutical ingredients and finished dosage form pharmaceutical products from other applicants, affiliated Indian companies. United States Food and Drug Administration inspected Indian applicants’ facilities and found they were non-compliant with good manufacturing practices requirements and it issued import alert on all products coming from Indian applicants except for products that were medically necessary. Newspaper began publishing articles and editorials that were critical of Health Canada and respondent Minister of Health. Minister imposed import ban preventing importation of drug products into Canada from Indian applicants’ manufacturing facilities and it also amended main applicant’s establishment licences to prohibit import of all products except those deemed medically necessary. Applicants applied for judicial review. Application granted. Minister acted for improper purpose and did not act in accordance with duty of procedural fairness when import ban was implemented and establishment licences were amended. There was no evidence that minister was concerned with immediate health risks posed by products subject to ban or that situation was highly urgent such that level of procedural fairness should be less. Regulatory regime and circumstances suggested that procedural fairness should have been given prior to import ban being implemented. Minister failed to provide any notice and denied main applicant opportunity to be heard before unilaterally imposing import ban. Minister did not act in accordance with natural justice. Applicants had not met burden of proving that minister demonstrated reasonable apprehension of bias from lack of independence or impartiality. Minister’s actions were ultra vires. Minister used proper statutory provision to add terms and conditions to main applicant’s establishment licences but in circumstances provision should include procedural fairness granted to establishment licence holders throughout rest of regulatory scheme, which required notice and reasons for addition of terms and conditions. Section 2(e) of Canadian Bill of Rights did not apply in circumstances. As minister implemented import ban that was motivated by improper purpose and without providing main applicant with procedural protections required by law, decision was not reasonable or correct and it must be quashed. Minister acted without jurisdiction in releasing statements to media and statements were to be retracted.
Apotex Inc. v. Canada (Minister of Health) (Oct. 14, 2015, F.C., M.D. Manson J., File No. T-2223-14) 259 A.C.W.S. (3d) 580.
