Timeliness and Transparency: Assessing the Review Process of HIV Drugs/Rapidit

The document examines issues surrounding the licensing of therapeutic products used to treat HIV/AIDS with a focus on pharmaceutical products that are new to the Canadian market. The authors analyze relevant background documents, and interview officials from Health Canada, representatives of the pharmaceutical industry, and treatment activists in community-based organizations. The paper highlights three problems: the length of time required to review new drug submissions, delays in filing new drug submissions, and a lack of transparency surrounding the process of reviewing drug submissions. A brief overview of the Canadian drug review processes is included along with a number of recommendations to address problems associated with the process.