Climate of Change Continues in Canada

Abstract

This paper provides a summary of recent changes to the legal, regulatory and policy environment affecting generic pharmaceutical manufacturers operating in the Canadian market. It provides a top-line overview of the Canadian pharmaceutical market in terms of generic market share by dollar value and prescriptions filled, and growth in both of those key indicators. This paper describes changes brought into force in October 2006 to regulations of Canada's Patent Act that attempt to limit ‘evergreening’ tactics employed by brand-name drug manufacturers to delay market entry of competing generic products, changes to regulations of Canada's Food and Drugs Act that provide new brand-name pharmaceutical products with eight years of data exclusivity (plus six-month paediatric exclusivity) and the response of the Canadian Generic Pharmaceutical Association (CGPA) to these regulatory changes. This paper also outlines changes to pricing and reimbursement rules for generic pharmaceutical products that are being implemented in the two largest Canadian jurisdictions of Ontario and Québec.