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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?!
Author: Sara Schlenkrich
Publisher: Anchor Academic Publishing (aap_verlag)
Total Pages: 69
Release: 2015-02
Genre: Business & Economics
ISBN: 3954893592

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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 Marketplace Reform

Pharmaceutical Marketplace Reform
Author: United States. Congress. Senate. Special Committee on Aging
Publisher:
Total Pages: 360
Release: 1994
Genre: Business & Economics
ISBN:

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U.S. Healthcare Reform and the Pharmaceutical Industry

U.S. Healthcare Reform and the Pharmaceutical Industry
Author: Arthur A. Daemmrich
Publisher:
Total Pages: 36
Release: 2011
Genre:
ISBN:

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Fiercely contested before, during, and since its passage, the 2010 Patient Protection and Affordable Care Act (ACA) will restructure the U.S. healthcare market if fully implemented in coming years. This article describes the institutional and political context in which the ACA was passed, and develops estimates of its likely impact on the biopharmaceutical industry. Universal insurance, either through a government-run system or by mandated purchase of private insurance, has been controversial in the United States since it was first proposed in the mid-1930s. Even in the absence of national health coverage, the United States became the world's largest prescription drug market and emerged as the global leader in new drug research and testing. With health benefits globally from the availability of new drugs, albeit for poorer populations only after patent terms expire, changes to the U.S. healthcare system are also of significance to patients and the pharmaceutical industry internationally. This article evaluates how the ACA will affect the size of the biopharmaceutical market and competitive dynamics within the industry. Estimates are developed for healthcare spending in 2015 and 2020, especially for expenditures on prescription drugs in nominal terms and as a percentage of overall health spending. The article concludes with a discussion of the political economy of insurance and the sustainability of largely free-pricing of pharmaceuticals in the United States.


Pharmaceutical Industry and Public Policy in Post-reform India

Pharmaceutical Industry and Public Policy in Post-reform India
Author: Reji K. Joseph
Publisher: Routledge
Total Pages: 250
Release: 2015-07-24
Genre: Business & Economics
ISBN: 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.


Pharmaceutical Reform

Pharmaceutical Reform
Author: Marc J. Roberts
Publisher: World Bank Publications
Total Pages: 357
Release: 2011-09-21
Genre: Medical
ISBN: 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.


To America's Health

To America's Health
Author: Henry I. Miller, MD
Publisher: Hoover Institution Press
Total Pages: 128
Release: 2013-11-01
Genre: Political Science
ISBN: 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.


The early benefit assessment in the context of the Act on the Reform of the Market for Medicinal Products (AMNOG)

The early benefit assessment in the context of the Act on the Reform of the Market for Medicinal Products (AMNOG)
Author: Sara Schlenkrich
Publisher: GRIN Verlag
Total Pages: 74
Release: 2014-10-10
Genre: Health & Fitness
ISBN: 3656766010

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Bachelor Thesis from the year 2013 in the subject Health - Miscellaneous, grade: 1,4, Neisse University Görlitz, course: V282129, language: English, abstract: The Act on the Reform of the Market for Medicinal Products, which entered into force on the 1st of January 2011, brought about a fundamental change in the balance of power on the pharmaceutical market. This thesis therefore sets out to answer the following question: What impact does the early benefit assessment in the context of the Act on the Reform of the Market for Medicinal Products have on the stakeholders of the healthcare system? To answer this question, this work 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. The following findings were reached: As the representative of the statutory health insurance funds, the Central Federal Association of Statutory Health Insurance Funds has gained in power and now decides, as a member of the Federal Joint Committee, on the added benefit of a drug and, depending on this decision, also on the future reimbursement rate. Pharmaceutical companies, however, are losing clout and must comply with the guidelines and assessments of the early benefit assessment. Patients stand to gain and lose out from the early benefit assessment. They are the ones who are ultimately dependent on the medicinal product and its improvement and benefit from a proven benefit. However, they have no say in the early benefit assessment procedure.