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In order to market and sell a new pharmaceutical drug in Canada, the Minister of Health requires the initial applicant to submit clinical test results demonstrating that the drug is safe and effective for human use. Subsequent applicants, who typically lack the resources to conduct expensive clinical trials, must refer to and rely upon the initial applicant's data in their applications to market a generic version of the drug. / On June 17, 2006, the federal government of Canada published a proposed data protection regulation, which would provide an initial applicant with eight years of protection for clinical test results submitted in a new drug submission. This protection would lead to an eight year period of market exclusivity for the drug associated with the clinical test data, regardless of whether that drug was protected by a Canadian patent. / In this thesis, the author first describes what data protection is on a practical level, and distinguishes data protection from other forms of intellectual property rights. Next, the author discusses how various jurisdictions choose to protect clinical test data submitted to their health authorities. Canada's international obligations pursuant to the NAFTA and the TRIPS Agreement are also examined. In this regard, the author argues that Canada is under no obligation to provide initial applicants with eight years of data protection. Furthermore, the author argues that exclusive time-limited property rights in clinical test data are difficult to justify from a theoretical perspective. Finally, the author prescribes certain legislative changes to Canada's proposed data protection regulation.

In 1994, the members of the World Trade Organisation (WTO) adopted the Agreement on Trade-Related Aspects of Intellectual Property (the "TRIPs Agreement") and thus committed themselves to respect certain standards for intellectual property protection. This thesis studies the scope of the standards for patent protection and their impact upon trade in medicines. The first part addresses the international dimension of the issue and explains how international trade in medicines can contribute to enhancing the level of global welfare. The first chapter argues that in order to fulfil this latter objective legislation relating to patents must be adapted to the economic and social situation of countries. The second chapter demonstrates that such adaptation is not only allowed, but is indeed encouraged by the provisions of the TRIPS Agreement. The second part of this thesis addresses the issue from a Canadian perspective, and discusses the way Canadian patent provisions applying to pharmaceuticals should be drafted so as to allow Canada to participate in---and to benefit from---international trade in medicines. Thus, I first analyse the factual, political, and legislative factors that influence the Canadian pharmaceutical industry. I then study the role of Canada as part of the integrated market for medicines, as well as the social, industrial and economic objectives underlying Canadian policies. I finally propose some modifications and adaptations to the Canadian Patent Act and suggest some orientations for future multilateral negotiations.

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