The Act on the Reform of the Market for Medicinal Products (AMNOG): A question of power?!

The Act on the Reform of the Market for Medicinal Products (AMNOG): A question of power?! PDF

Author: Sara Schlenkrich

Publisher: diplom.de

Published: 2015-02-01

Total Pages: 66

ISBN-13: 3954898594

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In the past, high costs have been incurred in particular by the market launch of new medicinal products. To date, it was not necessary to demonstrate an additional therapeutic benefit. This changed with the Act on the Reform of the Market for Medicinal Products (AMNOG), which entered into force on the 1st of January 2011. It brought about a fundamental change in the balance of power on the pharmaceutical market. This study therefore sets out to answer the following question: What impact does the early benefit assessment in the context of the AMNOG have on the stakeholders of the healthcare system? To answer this question, this survey first presents the theoretical foundations of the law, of the early benefit assessment and the bodies involved. It then takes stock of the decisions taken to date before describing the impact on the selected stakeholders.

Pharmaceutical Industry and Public Policy in Post-reform India

Pharmaceutical Industry and Public Policy in Post-reform India PDF

Author: Reji K. Joseph

Publisher: Routledge

Published: 2015-07-24

Total Pages: 250

ISBN-13: 1317408837

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This book examines the impact of economic reforms in India on the pharmaceutical industry and access to medicines. It traces the changing production and trade pattern of the industry, research and development (R&D) preferences and strategies of Indian pharmaceutical firms, patent system alongside pricing policy measures and their shortcomings. It also analyses the public health financing system in India driven largely by out-of-pocket expenditure — about 60 per cent — and characterised by very high share of medicines in total health expenditure. A masterful insight into a topical area, the work will be indispensable to those working on pharmaceutical industry and public policy. It will be of interest to researchers, scholars, students, and policy-makers of economics, industrial policy, public policy, intellectual property rights and health financing.

To America's Health

To America's Health PDF

Author: Henry I. Miller, MD

Publisher: Hoover Institution Press

Published: 2013-11-01

Total Pages: 128

ISBN-13: 081799906X

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A government monopoly over drug regulation is not sacrosanct. This hard-hitting book describes the current regulation of drugs by the FDA and proposes a model for fundamental, yet workable, reform—including an innovative proposal for drug testing and certification review.

Economic Regulation and Its Reform

Economic Regulation and Its Reform PDF

Author: Nancy L. Rose

Publisher: University of Chicago Press

Published: 2014-08-29

Total Pages: 619

ISBN-13: 022613816X

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The past thirty years have witnessed a transformation of government economic intervention in broad segments of industry throughout the world. Many industries historically subject to economic price and entry controls have been largely deregulated, including natural gas, trucking, airlines, and commercial banking. However, recent concerns about market power in restructured electricity markets, airline industry instability amid chronic financial stress, and the challenges created by the repeal of the Glass-Steagall Act, which allowed commercial banks to participate in investment banking, have led to calls for renewed market intervention. Economic Regulation and Its Reform collects research by a group of distinguished scholars who explore these and other issues surrounding government economic intervention. Determining the consequences of such intervention requires a careful assessment of the costs and benefits of imperfect regulation. Moreover, government interventions may take a variety of forms, from relatively nonintrusive performance-based regulations to more aggressive antitrust and competition policies and barriers to entry. This volume introduces the key issues surrounding economic regulation, provides an assessment of the economic effects of regulatory reforms over the past three decades, and examines how these insights bear on some of today’s most significant concerns in regulatory policy.

Pharmaceutical Marketplace Reform

Pharmaceutical Marketplace Reform PDF

Author: United States Congress Senate Spec

Publisher: Legare Street Press

Published: 2022-10-27

Total Pages: 0

ISBN-13: 9781018596112

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This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work is in the "public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.

Pills, Power, and Policy

Pills, Power, and Policy PDF

Author: Dominique A. Tobbell

Publisher: Univ of California Press

Published: 2012

Total Pages: 310

ISBN-13: 0520271149

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"Tobbell analyzes the political and economic history of the alignment of the pharmaceutical industry, academic institutions and their faculty and organized medicine. This book is essential reading for policymakers and their staff as well as persons who study the history of health policy and those who contribute to it through medical research, advocacy and journalism. " -Daniel Fox, author of The Convergence of Science and Governance: Research, Health Policy, and American States "Dominique Tobbell’s vivid, balanced and probing account of pharmaceutical politics is a significant, needed analysis of the relationships between the pharmaceutical industry, university researchers, the medical profession and government in the Cold War period. More than this, Pills, Power, and Policy shows why it continues to be difficult to agree in the United States on the relative roles of corporate enterprise, government regulation, technological innovation, freedom to prescribe, and consumer marketing and protection, all played out against the rising costs of health care. Timely and thought-provoking."--Rosemary A. Stevens. DeWitt Wallace Distinguished Scholar, Department of Psychiatry, Weill Cornell Medical College "A superb and compelling account of the creation of one of America’s most reviled entities: Big Pharma. With clarity and subtlety, Pills, Power, and Policy weaves together the political, economic, and the medical to reveal the entangled history behind our modern pharmaceutical predicament."--Andrea Tone, Ph.D., Professor of History & Canada Research Chair in the Social History of Medicine, McGill University “Pills, Power and Policy provides an outstanding description and analysis of the evolution of drug policy. It is an extremely important contribution to our understanding of the political, scientific, and economic nature of pharmaceutical regulation." -Daniel S. Greenberg, Washington journalist and author of Science, Money and Politics: Political Triumph and Ethical Erosion

Pharmaceutical Reform

Pharmaceutical Reform PDF

Author: Marc J. Roberts

Publisher: World Bank Publications

Published: 2011-09-21

Total Pages: 357

ISBN-13: 082138760X

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This book applies an established analytical framework for health sector reform (Getting Health Reform Right, Oxford, 2004) to the performance problems of the pharmaceutical sector. The book is divided into three sections. The first section presents the basic ideas for analysis. It begins by insisting that reform start with a clear understanding of the performance deficiencies of the current system. Like all priority setting in the public sector, this 'definition of the problem' involves both ethical choices and political processes. Early chapters explain the foundations of these ideas and apply them to the pharmaceutical sector. The relationship of ultimate outcomes (like health status or risk protection) to classic health systems concepts like efficiency, access and quality is also explored. The last chapter in the first part is devoted to 'diagnosis'—explaining how to move from the definition of a problem to an understanding of how the functioning of the system produces the undesirable outcomes in question. The second part of the book devotes one chapter to each of five 'control knobs': finance, payment, organization, regulation and persuasion. These are sets of potential interventions that governments can use to improve pharmaceutical sector performance. Each chapter presents basic concepts and discusses examples of reform options. Throughout we provide 'conditional guidance'—avoiding the approach of a 'one size fits all' model of 'best practices' in these five arenas for reform. Instead we stress the need for local knowledge of political systems, administrative capacities, community values and market conditions in order to design pharmaceutical sector policies appropriate to a country’s particular circumstances. The last part of the book is a set of teaching cases. Each is preceded by questions and is followed by a brief note on the lessons to be learned. The goal is to help readers develop the skills they need to deal effectively with pharmaceutical sector reform problems in their own countries.