The Regulation of Drugs in Canada: The "Food and Drugs Act" and Related Intellectual Property Regimes

The Regulation of Drugs in Canada: The Food and Drugs Act and Related Intellectual Property Regimes provides an overview of the laws in Canada that govern the manufacture and sale of drugs that are subject to the Food and Drugs Act, including pharmaceuticals, vaccines, and natural health products. Among the laws that are discussed are the new regulatory pathways that were made in response to the COVID-19 pandemic. This book also describes the intellectual property framework that applies to drugs and explains the impact this framework has on the drug approval process, as well as its unique objective: to encourage innovation and incentivize bringing new therapeutic options to market. Authors Simon Carvalho, T. Nessim Abu-Zahra, and David Edwards explain how this framework regulates the competition between “brand-name manufacturers” who are the first to bring a drug to market and obtain patents and other intellectual property, and “generic” or “biosimilar” manufacturers, who manufacture and sell copies of brand-name products.  Read more