Regulation and Welfare: Evidence from Paragraph IV Generic Entry in the Pharmaceutical Industry

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ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (99 download)

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Book Synopsis Regulation and Welfare: Evidence from Paragraph IV Generic Entry in the Pharmaceutical Industry by :

Download or read book Regulation and Welfare: Evidence from Paragraph IV Generic Entry in the Pharmaceutical Industry written by and published by . This book was released on 2011 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Regulation and welfare : evidence from Paragraph IV generic entry in the pharmaceutical industry

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Publisher :
ISBN 13 :
Total Pages : 39 pages
Book Rating : 4.:/5 (741 download)

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Book Synopsis Regulation and welfare : evidence from Paragraph IV generic entry in the pharmaceutical industry by : Lee Branstetter

Download or read book Regulation and welfare : evidence from Paragraph IV generic entry in the pharmaceutical industry written by Lee Branstetter and published by . This book was released on 2011 with total page 39 pages. Available in PDF, EPUB and Kindle. Book excerpt: With increasing frequency, generic drug manufacturers in the United States are able to challenge the monopoly status of patent-protected drugs even before their patents expire. The legal foundation for these challenges is found in Paragraph IV of the Hatch-Waxman Act. If successful, these Paragraph IV challenges generally lead to large market share losses for incumbents and sharp declines in average market prices. This paper estimates, for the first time, the welfare effects of accelerated generic entry via these challenges. Using aggregate brand level sales data between 1997 and 2008 for hypertension drugs in the U.S. we estimate demand using a nested logit model in order to back out cumulated consumer surplus, which we find to be approximately $270 billion. We then undertake a counterfactual analysis, removing the stream of Paragraph IV facilitated generic products, finding a corresponding cumulated consumer surplus of $177 billion. This implies that gains flowing to consumers as a result of this regulatory mechanism amount to around $92 billion or about $133 per consumer in this market. These gains come at the expense to producers who lose, approximately, $14 billion. This suggests that net short-term social gains stands at around $78 billion. We also demonstrate significant cross-molecular substitution within the market and discuss the possible appropriation of consumer rents by the insurance industry. Policy and innovation implications are also discussed.

Regulation and Welfare

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Publisher :
ISBN 13 :
Total Pages : 41 pages
Book Rating : 4.:/5 (13 download)

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Book Synopsis Regulation and Welfare by : Lee Branstetter

Download or read book Regulation and Welfare written by Lee Branstetter and published by . This book was released on 2015 with total page 41 pages. Available in PDF, EPUB and Kindle. Book excerpt: With increasing frequency, generic drug manufacturers in the United States are able to challenge the monopoly status of patent-protected drugs even before their patents expire. The legal foundation for these challenges is found in Paragraph IV of the Hatch-Waxman Act. If successful, these Paragraph IV challenges generally lead to large market share losses for incumbents and sharp declines in average market prices. This paper estimates, for the first time, the welfare effects of accelerated generic entry via these challenges. Using aggregate brand level sales data between 1997 and 2008 for hypertension drugs in the U.S. we estimate demand using a nested logit model in order to back out cumulated consumer surplus, which we find to be approximately $270 billion. We then undertake a counterfactual analysis, removing the stream of Paragraph IV facilitated generic products, finding a corresponding cumulated consumer surplus of $177 billion. This implies that gains flowing to consumers as a result of this regulatory mechanism amount to around $92 billion or about $133 per consumer in this market. These gains come at the expense to producers who lose, approximately, $14 billion. This suggests that net short-term social gains stands at around $78 billion. We also demonstrate significant cross-molecular substitution within the market and discuss the possible appropriation of consumer rents by the insurance industry. Policy and innovation implications are also discussed.

Generic drug entry prior to patent expiration an FTC study

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Publisher : DIANE Publishing
ISBN 13 : 1428951938
Total Pages : 129 pages
Book Rating : 4.4/5 (289 download)

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Book Synopsis Generic drug entry prior to patent expiration an FTC study by :

Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:

A Mechanism for Encouraging Innovation

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Publisher :
ISBN 13 :
Total Pages : 56 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis A Mechanism for Encouraging Innovation by : Michael Kremer

Download or read book A Mechanism for Encouraging Innovation written by Michael Kremer and published by . This book was released on 1996 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Markets for Technology

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Publisher : MIT Press
ISBN 13 : 0262261367
Total Pages : 351 pages
Book Rating : 4.2/5 (622 download)

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Book Synopsis Markets for Technology by : Ashish Arora

Download or read book Markets for Technology written by Ashish Arora and published by MIT Press. This book was released on 2004-01-30 with total page 351 pages. Available in PDF, EPUB and Kindle. Book excerpt: The past two decades have seen a gradual but noticeable change in the economic organization of innovative activity. Most firms used to integrate research and development with activities such as production, marketing, and distribution. Today firms are forming joint ventures, research and development alliances, licensing deals, and a variety of other outsourcing arrangements with universities, technology-based start-ups, and other established firms. In many industries, a division of innovative labor is emerging, with a substantial increase in the licensing of existing and prospective technologies. In short, technology and knowledge are becoming definable and tradable commodities. Although researchers have made significant advances in understanding the determinants and consequences of innovation, until recently they have paid little attention to how innovation functions as an economic process. This book examines the nature and workings of markets for intermediate technological inputs. It looks first at how industry structure, the nature of knowledge, and intellectual property rights facilitate the development of technology markets. It then examines the impacts of these markets on firm boundaries, the division of labor within the economy, industry structure, and economic growth. Finally, it examines the implications of this framework for public policy and corporate strategy. Combining theoretical perspectives from economics and management with empirical analysis, the book also draws on historical evidence and case studies to flesh out its research results.

The Influence of the Pharmaceutical Industry

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Publisher : The Stationery Office
ISBN 13 : 9780215024572
Total Pages : 556 pages
Book Rating : 4.0/5 (245 download)

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Book Synopsis The Influence of the Pharmaceutical Industry by : Great Britain: Parliament: House of Commons: Health Committee

Download or read book The Influence of the Pharmaceutical Industry written by Great Britain: Parliament: House of Commons: Health Committee and published by The Stationery Office. This book was released on 2005-04-26 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: Incorporating HC 1030-i to iii.

Intellectual Property Law and Access to Medicines

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Publisher : Taylor & Francis
ISBN 13 : 1000398730
Total Pages : 428 pages
Book Rating : 4.0/5 (3 download)

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Book Synopsis Intellectual Property Law and Access to Medicines by : Srividhya Ragavan

Download or read book Intellectual Property Law and Access to Medicines written by Srividhya Ragavan and published by Taylor & Francis. This book was released on 2021-07-28 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors – states, transnational business corporations, or civil society groups – and their influence on the structures – such as national and international agreements, organizations, and private entities – that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

Nonparametric Econometrics

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Publisher : Cambridge University Press
ISBN 13 : 0521355648
Total Pages : 446 pages
Book Rating : 4.5/5 (213 download)

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Book Synopsis Nonparametric Econometrics by : Adrian Pagan

Download or read book Nonparametric Econometrics written by Adrian Pagan and published by Cambridge University Press. This book was released on 1999-06-28 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering the vast literature on the nonparametric and semiparametric statistics and econometrics that has evolved over the last five decades, this book will be useful for first year graduate courses in econometrics.

The Oxford Handbook of the Economics of the Biopharmaceutical Industry

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Publisher : Oxford University Press
ISBN 13 : 0199909261
Total Pages : 618 pages
Book Rating : 4.1/5 (999 download)

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Book Synopsis The Oxford Handbook of the Economics of the Biopharmaceutical Industry by : Patricia M. Danzon

Download or read book The Oxford Handbook of the Economics of the Biopharmaceutical Industry written by Patricia M. Danzon and published by Oxford University Press. This book was released on 2012-04-12 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biopharmaceutical industry has been a major driver of technological change in health care, producing unprecedented benefits for patients, cost challenges for payers, and profits for shareholders. As consumers and companies benefit from access to new drugs, policymakers around the globe seek mechanisms to control prices and expenditures commensurate with value. More recently the 1990s productivity boom of new products has turned into a productivity bust, with fewer and more modest innovations, and flat or declining revenues for innovative firms as generics replace their former blockbuster products. This timely volume examines the economics of the biopharmaceutical industry, with eighteen chapters by leading academic health economists. Part one examines the economics of biopharmaceutical innovation including determinants of the costs and returns to new drug development; how capital markets finance R&D and how costs of financing the biopharmaceutical industry compare to financing costs for other industries; the effects of safety and efficacy regulation by the Food and Drug Administration (FDA) and of price and reimbursement regulation on incentives for innovation; and the role of patents and regulatory exclusivities. Part two examines the market for biopharmaceuticals with chapters on prices and reimbursement in the US, the EU, and other industrialized countries, and in developing countries. It looks at the optimal design of insurance for drugs and the effects of cost sharing on spending and on health outcomes; how to measure the value of pharmaceuticals using pharmacoeconomics, including theory, practical challenges, and policy issues; how to measure pharmaceutical price growth over time and recent evidence; empirical evidence on the value of pharmaceuticals in terms of health outcomes; promotion of pharmaceuticals to physicians and consumers; the economics of vaccines; and a review of the evidence on effects of mergers, acquisitions and alliances. Each chapter summarizes the latest insights from theory and recent empirical evidence, and outlines important unanswered questions and areas for future research. Based on solid economics, it is nevertheless written in terms accessible to the general reader. The book is thus recommended reading for academic economists and non-economists, and for those in industry and policy who wish to understand the economics of this fascinating industry.

Corporate Crime in the Pharmaceutical Industry (Routledge Revivals)

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Publisher : Routledge
ISBN 13 : 1135072906
Total Pages : 451 pages
Book Rating : 4.1/5 (35 download)

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Book Synopsis Corporate Crime in the Pharmaceutical Industry (Routledge Revivals) by : John Braithwaite

Download or read book Corporate Crime in the Pharmaceutical Industry (Routledge Revivals) written by John Braithwaite and published by Routledge. This book was released on 2013-10-08 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade

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Publisher : WIPO
ISBN 13 : 9280523082
Total Pages : 259 pages
Book Rating : 4.2/5 (85 download)

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Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization

Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

The Economics of New Goods

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Publisher : University of Chicago Press
ISBN 13 : 0226074188
Total Pages : 508 pages
Book Rating : 4.2/5 (26 download)

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Book Synopsis The Economics of New Goods by : Timothy F. Bresnahan

Download or read book The Economics of New Goods written by Timothy F. Bresnahan and published by University of Chicago Press. This book was released on 2008-04-15 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: New goods are at the heart of economic progress. The eleven essays in this volume include historical treatments of new goods and their diffusion; practical exercises in measurement addressed to recent and ongoing innovations; and real-world methods of devising quantitative adjustments for quality change. The lead article in Part I contains a striking analysis of the history of light over two millenia. Other essays in Part I develop new price indexes for automobiles back to 1906; trace the role of the air conditioner in the development of the American south; and treat the germ theory of disease as an economic innovation. In Part II essays measure the economic impact of more recent innovations, including anti-ulcer drugs, new breakfast cereals, and computers. Part III explores methods and defects in the treatment of quality change in the official price data of the United States, Canada, and Japan. This pathbreaking volume will interest anyone who studies economic growth, productivity, and the American standard of living.

The Global Politics of Pharmaceutical Monopoly Power

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Publisher :
ISBN 13 : 9789079700066
Total Pages : 136 pages
Book Rating : 4.7/5 ( download)

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Book Synopsis The Global Politics of Pharmaceutical Monopoly Power by : Ellen F. M. 't Hoen

Download or read book The Global Politics of Pharmaceutical Monopoly Power written by Ellen F. M. 't Hoen and published by . This book was released on 2009 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: In The Global Politics of Pharmaceutical Monopoly Power, researcher and global advocate Ellen 't Hoen explains how new global rules for pharmaceutical patenting impact access to medicines in the developing world. The book gives an account of the current debates on intellectual property, access to medicines, and medical innovation, and provides historical context that explains how the current system emerged. This book supports major policy changes in the management of pharmaceutical patents and the way medical innovation is financed in order to protect public health and, in particular, promote access to essential medicines for all. The Open Society Institute provided support to translate this report into Russian.

Research Methods in Practice

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Publisher : SAGE Publications
ISBN 13 : 1544318405
Total Pages : 650 pages
Book Rating : 4.5/5 (443 download)

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Book Synopsis Research Methods in Practice by : Dahlia K. Remler

Download or read book Research Methods in Practice written by Dahlia K. Remler and published by SAGE Publications. This book was released on 2021-08-24 with total page 650 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly updated to reflect changes in both research and methods, this Third Edition of Remler and Van Ryzin’s innovative, standard-setting text is imbued with a deep commitment to making social and policy research methods accessible and meaningful. Research Methods in Practice: Strategies for Description and Causation motivates readers to examine the logic and limits of social science research from academic journals and government reports. A central theme of causation versus description runs through the text, emphasizing the idea that causal research is essential to understanding the origins of social problems and their potential solutions. Readers will find excitement in the research experience as the best hope for improving the world in which we live, while also acknowledging the trade-offs and uncertainties in real-world research.

WHO guideline on country pharmaceutical pricing policies

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Publisher : World Health Organization
ISBN 13 : 9240011870
Total Pages : 70 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis WHO guideline on country pharmaceutical pricing policies by :

Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.

Selection and Decision in Judicial Process Around the World

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Publisher : Cambridge University Press
ISBN 13 : 110847487X
Total Pages : 313 pages
Book Rating : 4.1/5 (84 download)

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Book Synopsis Selection and Decision in Judicial Process Around the World by : Yun-chien Chang

Download or read book Selection and Decision in Judicial Process Around the World written by Yun-chien Chang and published by Cambridge University Press. This book was released on 2019-12-19 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: Leading empirical legal scholars from around the world explore whether and under what conditions the judicial process is efficient.