Correspondence: Jim Keon, Canadian Generic Pharmaceutical Association, 4120 Yonge Street, Suite 409, Toronto, Ontario, Canada M2P 2B8. Tel: 416 223 2333; Fax: 416 223 2425; E-mail: jim@canadiangenerics.ca Web: www.canadiangenerics.ca

¹is President of the Canadian Generic Pharmaceutical Association (CGPA), the national organization representing Canada's generic pharmaceutical industry. Prior to joining the CGPA in 1994 (he became President in 1998), Mr Keon held several senior positions in the Government of Canada and was directly involved in Canada's international trade negotiations for the Free-Trade Agreement with the United States, the North American Free-Trade Agreement (NAFTA) and Canada's entry into the World Trade Organization (WTO), as well as inter-provincial trade negotiations in Canada. Mr Keon graduated with a Masters Degree in Economics from Queen's University in Kingston, Ontario, Canada and has extensive experience in areas of intellectual property, trade and consumer protection. He is also a member of the Management Committee of the International Generic Pharmaceutical Alliance (IGPA).

Received 20 December 2007; Revised 20 December 2007; Published online 5 February 2008.

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.