Whose Data? The Public Interest in Clinical Trial Information in Canada

Traditionally, the conception of clinical trial information has only recognized the commercial interest of the trial sponsor. This understanding has gradually shifted as the public interest in clinical trial information, which is grounded in the public contributions to the production of the information, has been recognized. The public interest is supported by the public health harms that can result when clinical trial information is kept confidential, and those public health harms reinforce the argument that the governmentâ s lack of transparency with respect to clinical trial information is an infringement of the freedom of expression and rights to life, liberty and security of the person. This paper will evaluate Health Canadaâ s current regime and argue that the public interest supports increased transparency of clinical trial information. It will also review the policies of the European Medicines Agency to demonstrate where there is room for improvement in the Canadian experience.LL.M