The Politics of Canada's Access to Medicines Regime: the Dogs that Didn't Bark by Laura Caroline Esmail A thesis submitted in conformity with the requirements for the degree of Doctor of Philosophy Graduate Department of Pharmaceutical Sciences University of Toronto © Copyright by Laura Caroline Esmail 2010 The Politics of Canada's Access to Medicines Regime: the Dog that Didn't Bark Laura Caroline Esmail Doctor of Philosophy Graduate Department of Pharmaceutical Sciences University of Toronto 2010 Abstract Decisions to reform pharmaceutical policy often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a reform that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only one order of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda for one year, has been exported. Future use of the regime appears unlikely. This research aimed to examine the politics underlying the formation of CAMR. Parliamentary committee hearing transcripts from CAMR's legislative development (2004) and from CAMR's legislative review (2007) were analyzed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analyzed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR's final policy design. ii In 2004, policy debates were dominated by two themes: intellectual property rights and TRIPS compliance. Promoting human rights and the impact of CAMR on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by a greater representation of the interests of potential beneficiary country governments. While the Government attempted to strike a balance between drug affordability and intellectual property protection, it designed CAMR as a last resort measure. Increased input from the developing country beneficiaries and shifting to institutions where the right to health gets prioritized may lead to policies that better achieves affordable drug access. iii Acknowledgements No one told me that this would be one of life's big tests…. or if they did, I didn't believe them. Looking back, I'm thankful that it was. At so many points, this thesis forced me to search for truths far deeper than the topic of my thesis. As life's big tests will undoubtedly continue, I'm grateful for the strength and wisdom that I've gained throughout this process, and for this, I have so many people to thank. First and foremost, I would like to thank my husband and my best friend, Nazim. His endless encouragement, support and love sustained me through this PhD. You helped me up whenever I fell down, you helped me step back when my eyes were too close to page, and you held my hand when things got tough and scary. What a privilege to have shared these graduate years with you. Your wisdom, strength and optimism are behind every word of this thesis and I too, without an ounce of hesitation, dedicate this thesis to you. Thank you. I would like to thank my family for their love and support, for helping me through the tough times and for celebrating the triumphs: Mom, thank you for always being there to listen and for even offering to help with my content analysis! Papa, thank you for being a model for academic excellence and for always being the first to ask when I was going to finish! Ali and Annie, thank you for always being there for me—your friendship means so much to me. Dalia and Aida, thank you for your love and encouragement throughout the years. Kam, Lyes, Yassine, Zahira and Mohammed– you have made me feel like I have an army of support behind me. Thank you so much for your love and encouragement. Academically, there are many people who have helped me along the way. First, many thanks are due to the members of my dissertation committee. I thank my supervisor, Jillian Kohler, for always pushing me to answer the "so what" question. You generously provided me with many opportunities to collaborate, present, publish and get real-world policy experience. Most of all, you encouraged me to play with the "big boys", which iv toughened me up– thank you for that! I thank Raisa Deber for her valuable guidance throughout this process and for showing me the ropes in public policy theory. Your door was always open and you were so generous with your time. Joel Lexchin, thank you for tirelessly reading every draft I sent your way, for treating me like a peer from day one, and for being a voice of reason. I thank Colleen Flood, for her guidance, support and insightful critiques of my work. Your combination of toughness and professionalism serves as a model for women in academe. Joan Marshman, thank you for your careful reads and for always trying to guide me towards the middle ground within this interdisciplinary maze. I thank my dissertation examiners, Heather Boon and Sue Horton: Heather, your penetrating comments on my methodology have undoubtedly made this a stronger thesis and will improve my work in the future; Sue, your perspective and critiques were invaluable and will help me appeal to a wider audience. I am grateful for the generous financial support provided to me throughout my doctoral program through the Social Sciences and Humanities Council of Canada, the Ontario Graduate Scholarship, the Ontario Training Centre for Health Services and Policy Research, the Pharmaceutical Policy Research Collaboration, the Leslie Dan Faculty of Pharmacy and the School of Graduate Studies, University of Toronto. Many thanks go to the staff at the Leslie Dan Faculty of Pharmacy for their administrative support. In particular, I would like to thank Donald Wong for his good- natured help, which made completing this PhD from different cities easier. I also owe many thanks to those that provided me quiet and friendly workspace during the nomadic stages of my doctorate: Keith Banting and Arthur Sweetman at Queen's University Policy Studies and Oksana Prokhvacheva at Gelman Library, George Washington University. Massey College profoundly transformed my academic experience and I would like to thank the administration and the Massey Junior Fellows for their camaraderie and friendship. Special gratitude goes to Ursula Franklin, a mother for so many Massey College Fellows, who helped us traverse the minefield of academe and reminded us of the importance of searching for truth and building knowledge. I would also like to thank v Anna Luengo, Janna Rosales, Sylvie Lamoureux, Jackie Feke, and Kim Stanton for their support, encouragement and friendship. I'd like to thank the global health activists that I've had the good fortune to work with and who have served as a constant source of inspiration to me: Rachel Kiddell-Monroe, Richard Elliott and Lisa Forman – the world needs more of you. Several of my colleagues also made the path to the PhD a little easier with their guidance, friendship and commiseration along the way. Andrea, Kaye and Vicky - what a pleasure it was to work with you! Raza, thank you for commiserating all of these years and of course, your assistance on the content analysis was invaluable. Rishma Walji and Natasha Kachan, thank you for your friendship and guidance. To my friends, Megan and Naomi – what a privilege to have had you by my side all these years. Naomi, thank you for your constant support, your insatiable curiosity and of course, for your Dryden sense of humour! Megan, although our crafts are very different, it has been a pleasure to write alongside you, commiserating through these long years of hard work with delayed gratification. You both picked up the phone at some crucial moments and made the tough times easier to bear… thank you. Finally, to the PhD students of the world… when in doubt, just remember what Woody Allen once said: "If you're not failing every now and again, it's a sign you're not doing anything very innovative." vi Table of Contents Abstract ............................................................................................................................... ii Acknowledgements ............................................................................................................ iv Table of Contents .............................................................................................................. vii List of Tables ...................................................................................................................... x List of Appendices .............................................................................................................. x List of Abbreviations ........................................................................................................