Electronic Thesis and Dissertation Repository


Master of Laws




Margaret Ann Wilkinson


This thesis explores, in the context of pharmaceutical clinical trials, Canadian federal, provincial and territorial personal data protection laws (which are consistent with Canada’s membership in the international Organization for Economic Cooperation and Development). This thesis establishes that, despite scholarly concerns over de-identifiability of data, these laws govern collection, use, dissemination, and disposal of data about individuals in clinical trials right through and including applications made by innovator pharmaceutical companies to the federal government for approval to market new drugs. At this latter point, federal data exclusivity regulations also apply (as required by international trade agreements). This thesis establishes that both personal data protection and data exclusivity apply to clinical trials only for defined periods. Finally this research demonstrates that, unlike protection of confidential information which remains secret and does not contribute to the public good of access to information, data exclusivity displays characteristics of classic intellectual property.

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