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TRADE REGULATION - Food and drugs - Drugs

Thursday, August 31, 2017 @ 8:33 AM  


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Appeal by the Council of Independent Community Pharmacy Owners from an order of an applications judge refusing to order the Minister of Health to more stringently enforce s. 4(e) of the Interchangeable Drug Products Formulary Regulations (Regulations) imposing on suppliers of generic pharmaceuticals an obligation to supply the whole province. Since 2012, the formulary included private label drugs supplied by companies that did not manufacture them. The appellant claimed that private label generics were leading to drug shortages. It argued that, under the Regulations, suppliers of generic pharmaceuticals had an ongoing obligation to supply the whole province and sought an order requiring the Minister to enforce that obligation and remove pharmaceuticals that failed to supply the whole province.

HELD: Appeal dismissed. The applications judge did not err in his determination that there was no public legal duty on the Minister to act. The Regulations contemplated that drugs should not be included in the formulary unless the supplier could supply the whole province. This requirement, however, only applied before the advisory committee would consider an initial application. Once the drug was included in the formulary, the imperative language of s. 4(e) no longer bound it. Once included, a drug remained in the formulary until it was removed. The requirements of s. 4 only applied once. The record did not support a conclusion that the Minister was refusing to enforce the Act or Regulations. The Minister had a broad discretionary power to remove drugs in the public interest, weighing a number of competing factors. Taken either individually or together, the decisions not to remove drugs were not so irrational as to constitute evidence of bad faith.

Council of Independent Community Pharmacy Owners Inc. v. Newfoundland and Labrador, [2017] N.J. No. 283, Newfoundland and Labrador Supreme Court - Court of Appeal, B.G. Welsh, C.W. White and M.F. Harrington JJ.A., July 25, 2017. Digest No. TLD-August282017010