Digests

Reddy-Cheminor Inc. v. Canada (Attorney General)

T-2294-00

2003 FCT 542, Layden-Stevenson J.

14/5/03

52 pp.

Applicant sought approval from Minister of Health to market its version of omeprazole (drug acting as gastric proton-pump inhibitor used to treat ulcers) pursuant to Food and Drugs Act (FDA) and Food and Drug Regulations-- Submitted abbreviated new drug submission (ANDS) and referred to Canadian reference product "Losec"--Minister's officials concluded medicinal ingredient in applicant's drug omeprazole while medicinal ingredient in "Losec" omeprazole magnesium--Minister refused to process submission and applicant now seeking judicial review of Minister's decision --Drug manufacturers prohibited from advertising or selling new drug in Canada without obtaining notice of compliance (NOC)--To obtain NOC, manufacturer files drug submission with Therapeutic Products Directorate (TPD) of Health Canada pursuant to Regulations, s. C.08.002(1), which prohibits sale of new drug unless manufacturer has filed NDS or ANDS satisfactory to Minister and has obtained NOC--S. C.08.002(2) delineates content requirements of NDS--NDS must include detailed reports of tests conducted to establish safety of new drug for purpose and under conditions recommended, as well as substantial evidence of clinical effectiveness of new drug for purpose and under conditions of use recommended--Such information typically voluminous, ranging from 100 to 300 volumes of data--Manufacturers wishing to copy marketed drug without having to provide detailed reports and substantial data demonstrating clinical safety, effectiveness must submit ANDS, requiring use of Canadian reference product i.e. drug for which safety, efficacy already demonstrated--Canadian reference product typically brand name drug and proposed generic copy required to be pharmaceutical equivalent--In general, products must be bioequivalent, route of administration must be same, conditions of use of new drug must fall within those approved for Canadian reference product--S. C.08.002.1(2) outlines submission content requirements for ANDS--Under TPD's Management of Drug Submissions policy, material submitted screened for acceptability--If deficiencies identified, sponsor has 45 days to respond--May appeal TPD decision to reject submission at screening stage to two levels--Applicant's Level I appeal rejected--At level II applicant initially informed ANDS would be returned to Bureau of Pharmaceutical Assessment for review, but subsequently informed ANDS would not be processed--Whether Court should intervene in respondent's decision applicant's application for ANDS approval would not be processed allegedly due to failure to meet requirements of s. C.08.002.1 of Regulations--Answer to question entails examination of process and procedure followed by respondent--Applicant not entitled to rely on mode of approval of Canadian reference product and scientific conclusions to be drawn therefrom-- Proper, objective consideration of individual submissions on case-by-case basis paramount over consistency, particularly when regard had to potential seriousness, in drug approval process, of possibility of repeating mistakes--Content of ANDS matter within Minister's discretion to determine-- Minister developing comprehensive policy for management of drug submissions--Applicant's failure to submit product containing identical amounts of identical medicinal ingredients as Canadian reference product fatal to applicant's submission--Nothing requiring Minister to proceed with review of submission when sponsor fails to meet submission content requirements--Minister adhered to policy whereby submissions found acceptable on screening will be reviewed --Since applicant's submission found not acceptable, submission not reviewed--Unless policy contravenes or contradicts provisions of FDA of Regulations, Court will not intervene--Applicant must establish reviewable error on part of ministerial delegate with respect to determination applicant did not meet requirement set out in s. C.08.002.1(1)(a)-- Appropriate standard of review patent unreasonableness-- Minister's decision not patently unreasonable--First, Minister only refused to proceed to review of ANDS--Having considered applicant's submission, Minister determined submission did not meet requirements set out in s. C.08.002.1(1)(a)--Submission contents, not having met regulatory provisions, rendered submission unacceptable for review--Second, general purpose of Regulations to ensure safety and efficacy of drugs--Submission must include certain specified information as set out in s. C.08.002.1(1)-- Satisfaction of condition precedent mechanism chosen by legislature to address safety and efficacy of generic drugs-- Finally, applicant not entitled to rely on mode of approval of Canadian reference product to remedy deficiencies in ANDS--Minister cannot evaluate specifications of substance that may be produced following in vivo metabolism-- Legislative requirement to consider ingredient contained in drug--Applicant not denied natural justice--Applicant had opportunity and did make submissions relative to issues of whether applicant's product containing identical amounts of medicinal ingredients as Canadian reference product and of whether drugs pharmaceutically equivalent--No basis upon which to grant requested relief--Application dismissed-- Food and Drugs Act, R.S.C., 1985, c. F-27--Food and Drug Regulations, C.R.C., c. 870, s. C.08.002 (as am. by SOR/95-411, s. 4), C.08.002.1 (as enacted idem, s. 5).