The Pharmaceutical/Biopharmaceutical Landscape— Traversing Canada's Patent and Regulatory Regimes

摘要

The pharmaceutical industry in Canada sits at the intersection of complex regimes intended to foster innovation while protecting health and safety. An understanding of the interplay between these regimes is essential for marketing a new drug in Canada. The marketing of drugs in Canada is regulated at both the federal and the provincial level. At the federal level, the regulatory environment relating to new drugs comprises: (1) regulation of the safety, efficacy, and quality of drugs under the Food and Drugs Act (FDA)1 and the Food and Drug Regulations (FDR).2 which also includes data protection provisions for innovative drugs; (2) linkage between regulatory approval and patent protection through the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations)3; and (3) controls over the prices of patented medicines by the Patented Medicine Prices Review Board (PMPRB), established under the Patent Act4 and further governed by the Patented Medicines Regulations.