Digests

Food and Drugs

Judicial review of Minister of Health, Director General Therapeutics Products Directorate (Health Canada) decision refusing to grant applicant permission to market drug in Canada containing disulfiram—Disulfiram used in treating alcoholism, sold in Canada between 1949–2001—Respondent rejecting applicant’s new drug submission (NDS), drug identification number (DIN) applications because NDS requiring clinical trial, product containing disulfiram considered to be new drug pursuant as defined in Food and Drug Regulations, C.R.C., c. 870, s. C.08.001(a)—Applicant asserting that disulfiram’s track record in Canada, millions of doses constituting “sufficient” time, quantity to make safety, efficacy self-evident—“Sufficient” in s. C.08.001 not meaning that passage of time, administration of many doses can dictate Minister’s satisfaction as to safety, efficacy—Implying standard that may be variable, depending on circumstances—Appropriate for respondents to make assessment whether time, quantity sufficient for determining safety, efficacy—DIN decision reasonable—Hospira Healthcare Corporation v. Canada (Attorney General), 2010 FC 213 considered as to NDS decision—Court disagreeing with Hospira if determining s. C.08.002 requiring all NDS applications be accompanied by clinical test data—However, in agreement with Hospira if stating respondents acting reasonably, within scope of regulations, if asking clinical test data to satisfy themselves as to safety, efficacy of candidate drug—Respondents not making any analysis herein of applicant’s applications—NDS decision therefore unreasonable—Application in T-706-10 dismissed; application in T-1537-07 allowed.

Wellesley Therapeutics Inc. v. Canada (Health) (T-1537-07, T-706-10, 2010 FC 573, Hughes J., judgment dated May 28, 2010, 36 pp.)