The Politics of Pharmaceutical Policy Reform: A Study of Generic Drug Regulation in Brazil PDF
Preview The Politics of Pharmaceutical Policy Reform: A Study of Generic Drug Regulation in Brazil
SpringerBriefs in Political Science Volume 26 SpringerBriefs present concise summaries of cutting-edge research and practical applications across a wide spectrum of fields. Featuring compact volumes of 50 to 125 pages, the series covers a range of content from professional to academic. Typi- cal topics might include: • A timely report of state-of-the art analytical techniques • A bridge between new research results, as published in journal articles, and a contextual literature review • A snapshot of a hot or emerging topic • A nin-depth case study or clinical example • A presentation of core concepts that students must understand in order to make independent contributions SpringerBriefs in Political Science showcase emerging theory, empirical research, and practical application in political science, policy studies, political economy, pub- lic administration, political philosophy, international relations, and related fields, from a global author community. SpringerBriefs are characterized by fast, global electronic dissemination, standard publishing contracts, standardized manuscript preparation and formatting guide- lines, and expedited production schedules. More information about this series at http://www.springer.com/series/8871 Elize Massard da Fonseca The Politics of Pharmaceutical Policy Reform A Study of Generic Drug Regulation in Brazil 1 3 Elize Massard da Fonseca Center for Public Administration and Government Studies, São Paulo Business School Getulio Vargas Foundation São Paulo Brazil ISSN 2191-5466 ISSN 2191-5474 (electronic) SpringerBriefs in Political Science ISBN 978-3-319-12564-0 ISBN 978-3-319-12565-7 (eBook) DOI 10.1007/978-3-319-12565-7 Library of Congress Control Number: 2014954747 Springer Cham Heidelberg New York Dordrecht London © Springer International Publishing Switzerland 2015 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com) The Generic Drug Act contributed significantly to local capital p harmaceutical industries, as they could effectively improve and develop qualitatively and qualitatively. National firms have done an i nteresting investment in know-how, technology, knowledge; such as that today they can compete equally in any international m arket. In other words, the regulation led firms to operate in another level, a higher level. […] In this sense, never in the history of the pharmaceutical sector in Brazil have you ever seen the situation we have today. Odnir Finotti President of the Brazilian Association of Generic Drug Manufacturers (2007–2012) v Foreword I have had the privilege to mentor and collaborate with Elize Massard da Fonseca since the very inception of her successful career. Initially, she joined our group as a young MPH candidate and dedicated her time and effort to the assessment and care- ful analysis of the socio-demographic profiles and behaviors of people who misuse different drugs, as well as their related harms and risks. She conducted detailed analyses and published relevant peer-reviewed articles on these themes. Subsequently, in partnership with both domestic and international collaborators, she realized HIV/AIDS either associated with alcohol and other drug misuse or not, had become a global issue with key local dimensions and that Brazil had become a major player in this field. Over the years, both aspects of her original research have merged and fertilized each other in what is currently called the “treatment as prevention” strategy, which seeks a full understanding of the double impact of antiretroviral treatment in terms of both the substantial improvement of individual survival, as well as the quality of life, and its dramatic impact at the level of fami- lies, social networks and whole communities. The proper, sustained use of such antiretroviral medicines constitutes a key component of any concerted effort to pre- vent new infections and to curb the epidemic. In this sense, her work invested in a sound connection that was later documented by seminal protocols, such as the HPTN 052 Protocol, which demonstrated a reduction of more than 90 % of new infections among serodiscordant couples receiving anti-retroviral treatment. This finding, which provided broad insights in advance of fine-grained biologi- cal evidence, is proof that innovative social scientists can and should pave the way for their colleagues from other fields of knowledge to explore such issues with their own tools, thereby helping to set research agendas and guide policymaking in the long run. However, Elize decided to move one step forward. Once again, in hindsight, it is now pretty clear that she had made another correct decision when she left Brazil after finishing her PhD in Public Health and moved to Europe, where she obtained a second post-graduate degree, this time in Social Policy. In this second postgradu- ate study, she examined old problems with new eyes and provided a much larger perspective by assessing generic medicines in a comprehensive sense. In this new initiative, she profited from her in-depth experience with AIDS medicines, but did vii viii Foreword not restrict herself to the lessons and challenges of a given sub-area of medicine innovation, regulation and policymaking. Instead, she inserted them into a much broader framework of politics and health policy. Once again, time proved she was right. Inserting our former questions and doubts into a much larger framework helped Brazilian and international experts to qualify the debate, to enlarge their own perspectives and to open their eyes for the questions to be addressed in the years to come. People who can see things ahead of the pressing daily needs share with the vi- sionaries of all ages the capacity to move one step forwards and guide us. I feel very happy to have supported her first initiatives and I anxiously wait for her new insights and for the scenarios that would emerge from such insights. Such issues will be debated not only by our present-day colleagues, but also by the generations to come. September 2014 Rio de Janeiro Dr. Francisco Inácio Bastos Senior Researcher, Oswaldo Cruz Foundation, Ministry of Health Acknowledgments This book was adapted from my doctoral thesis in Social Policy at the University of Edinburgh, UK1. When conducting this research, I was fortunate in being able to count on the support of various people and institutions. I am mostly thankful for the constant guidance and intellectual challenge of my supervisors Daniel Clegg and Jeff Collin. I am equally grateful to Alison Koswloski and Richard Freeman who helped me tailor the object of this analysis in my first year of the doctoral program. I have also benefited from comments and encouragement from other academics and experts. Scott Greer and Holly Jarman from the University of Michigan and Amy Nunn, a long time research partner, from Brown University, provided helpful advice at different stages of this research. For providing feedback on several aspects of Brazilian health system, I would also like to thank Francisco Bastos and Nilson Costa from the Oswado Cruz Foundation in Brazil. No words could express my gratitude for their generosity and friendship during this period. Ken Shadlen, from the London School of Economics and Richard Parry, Edinburgh, were the examin- ers of the thesis. I thank both for their comments and challenging questions. I owe my initial interest in regulatory policy to Carlos Pereira. The empirical core of this book was conducted during six months of field re- search in Brazil, partially funded by the University of Edinburgh Development Trust. During this period, I met and interviewed many participants of pharmaceuti- cal regulation in Brazil, from politicians and government officials to business ex- ecutives and nongovernmental organization representatives. Without their kindness in sharing some time in their busy schedules, this research would not have been possible. I cannot mention all of them here but I must cite Jose Eduardo Bandeira de Mello, who shared a number of historical documents on the generic drug reform and spent many hours talking to me about the pharmaceutical sector in Brazil. Jose Serra, Eduardo Jorge, Gonzalo Vecina Neto and Vera Valente explained to me in ex- traordinary detail the political process of bargaining the Generic Drug Act. Several local pharmaceutical industrialists and NGOs generously agreed to talk to me about the challenges to adapt to the new regulatory environment. 1 A consolidated version of my thesis, with some of the arguments discussed here, was published in Policy and Society in 2014, volume 33, issue 1, pp. 65–76. ix x Acknowledgments This manuscript was revised and adapted into a book during my postdoctoral fel- lowship at the Getulio Vargas Foundation (grants No 2012/01195-7 and 2014/07725- 3 of the Sao Paulo State Research Foundation, Fapesp) between 2012 and 2014. I thank Springer and Kevin Halligan for all their support during the editorial process. My office colleagues in Edinburgh were my family abroad. I thank François Briatte, Amadu Kan and Evgeniya Plotnikova for their kind support throughout this process. Mostly important, I thank my parents, Marilia and Adivaldo, my brother and sister-in-law, Henrique and Juliane, and Rafael for their unconditional love and endless encouragement. My parents gave me the support to conduct this work from my first day in Edinburgh to the final version of the manuscript that was prepared in São Paulo. This book is dedicated to my new family member, Maria Julia—our little princess and book-eater.
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