"I Shouldn’t Copy, Right?" Why Pharmaceutical Companies Should Care About Copyright

The Product Monograph

In the pharmaceutical industry, the issue of copyright can arise in the context of product monographs. Once approved by Health Canada, product monographs are publicly available documents and contain the information for safe and effective use of a drug. It is drafted and redrafted as Health Canada and the drug manufacturer discuss the product and exchange information. A final approved product monograph may not include all of the information exchanged between the parties, but is the result of discussions and compromise between them. It is published as part of the Notice of Compliance ("NOC") issued by Health Canada and without it, the drug product cannot be sold.