• patenting
• health policy
• pharmaceuticals
• industrial policy

The central objective of this study is to examine the factors that have influenced the evolution of the drug patenting regulatory framework in Canada from 1965 to 2005. The principal focus is on the extent to which in formulating that regulatory framework the Canadian federal government has been influenced by domestic and international interests and forces. In examining the domestic interests and forces attention is devoted to the financial interests of the two sectoral associations representing the patented and generic drug manufacturers and the economic and political interests of the governing and opposition parties. In examining the international interests and forces the focus is both on the emergence of international institutions and agreements and on the interests of various countries and drug companies located therein which wanted to ensure that Canada’s regulatory framework would not have an adverse effect on them.

This study reveals that there was three relatively distinct phases in the evolution of Canada’s drug patenting regulatory framework and that each was influenced primarily by different sets of factors. The first phase which lasted from 1965 to 1991 was influenced entirely by domestic interests and forces produced by a highly charged political debate over reduced patent protection and drug price restrictions on the one hand, and increased patent protection and economic development on the other. The second phase, which lasted from 1992 to 2001, consisted largely of international forces. This included the emergence of new international institutions and agreements such as the World Trade Organization and the North American Free Trade Agreement, which created new intellectual property obligations for Canada and provided for even longer periods of patent protection than what had already existed. The third phase which began 2002 and continues to the present day, consists of a combination of domestic and international forces which attempt to reconcile domestic issues such as price restriction and economic development with international issues such as allowing Third World countries an opportunity to import drugs at reasonable prices. The Government of Canada’s response to all of these pressures has predominantly reflected the objectives of patented drug manufacturers.