The Changing Economics of Medical Technology PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download The Changing Economics of Medical Technology PDF full book. Access full book title The Changing Economics of Medical Technology by Institute of Medicine. Download full books in PDF and EPUB format.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225
Get Book Here
Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225
Get Book Here
Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author: Scott L. Greer
Publisher: World Health Organization
ISBN: 9289050438
Category : Law
Languages : en
Pages : 191
Get Book Here
Book Description
Civil Society Organizations (CSOs) can make a vital contribution to public health and health systems but harnessing their potential is complex in a Europe where government-CSO relations vary so profoundly. This study is intended to outline some of the challenges and assist policy-makers in furthering their understanding of the part CSOs can play in tandem and alongside government. To this end it analyses existing evidence and draws on a set of seven thematic chapters and six mini case studies. They examine experiences from Austria Bosnia-Herzegovina Belgium Cyprus Finland Germany Malta the Netherlands Poland the Russian Federation Slovenia Turkey and the European Union and make use of a single assessment framework to understand the diverse contexts in which CSOs operate. The evidence shows that CSOs are ubiquitous varied and beneficial and the topics covered in this study reflect such diversity of aims and means: anti-tobacco advocacy food banks refugee health HIV/AIDS prevention and cure and social partnership. CSOs make a substantial contribution to public health and health systems with regards to policy development service delivery and governance. This includes evidence provision advocacy mobilization consensus building provision of medical services and of services related to the social determinants of health standard setting self-regulation and fostering social partnership. However in order to engage successfully with CSOs governments do need to make use of adequate tools and create contexts conducive to collaboration. To guide policy-makers working with CSOs through such complications and help avoid some potential pitfalls the book outlines a practical framework for such collaboration. This suggests identifying key CSOs in a given area; clarifying why there should be engagement with civil society; being realistic as to what CSOs can or will achieve; and an understanding of how CSOs can be helped to deliver.
Author: Cheng Yee Lowe
Publisher: CRC Press
ISBN: 9781574910643
Category : Technology & Engineering
Languages : en
Pages : 286
Get Book Here
Book Description
Written by an expert with twenty years' experience in regulatory affairs in a number of multi-national companies, this book guides readers through the legislative minefield of registering medicinal products in the European Union. Taking a step-by-step approach, the book demystifies all of the regulatory requirements and gives a clear understanding of how to achieve compliance. The author gathers all the relevant requirements, puts them into context, and provides regulatory information in an easily accessible format. Headings, subheadings, and key points organized in tabular format make the information easy for readers to find and the book easy for readers to use.
Author: Congressional Budget Office
Publisher: Lulu.com
ISBN: 1304121445
Category : Science
Languages : en
Pages : 65
Get Book Here
Book Description
Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...
Author: Helena Legido-Quigley
Publisher: World Health Organization
ISBN: 9289071931
Category : Medical
Languages : en
Pages : 242
Get Book Here
Book Description
People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Author: Sally Shorthose
Publisher: Kluwer Law International B.V.
ISBN: 9041170022
Category : Law
Languages : en
Pages : 590
Get Book Here
Book Description
In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and ‘essential similarity’; - paediatric use and the requisite additional trials; - biologicals and ‘biosimilars’; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Author: Ellen F. M. 't Hoen
Publisher:
ISBN: 9789079700066
Category : Agreement on Trade-Related Aspects of Intellectual Property Rights
Languages : en
Pages : 136
Get Book Here
Book Description
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.
Author: Mckee
Publisher: McGraw-Hill Education (UK)
ISBN: 0335226442
Category : Medical
Languages : en
Pages : 312
Get Book Here
Book Description
While there may be consensus on the broader issues of the core objectives of the health care system, expectations differ between EU countries, and European national policy-makers. This book seeks firstly to assess the impact of the enlargement process and then to analyse the challenges that lie ahead in the field of health and health policy.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
Get Book Here
Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author:
Publisher: World Health Organization
ISBN: 9240011870
Category : Business & Economics
Languages : en
Pages : 70
Get Book Here
Book Description
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.
