The Role of NIH in Drug Development Innovation and Its Impact on Patient Access PDF Download

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498511
Category : Medical
Languages : en
Pages : 103

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Book Description
To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Author: World Intellectual Property Organization
Publisher: WIPO
ISBN: 9280523082
Category : Law
Languages : en
Pages : 259

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Book Description
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.

Author: Julia Black
Publisher: Edward Elgar Publishing
ISBN: 1845427971
Category : Law
Languages : en
Pages : 240

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Book Description
The book is a good read due to its well-integrated form, its comparative approach, its empirical case descriptions and its ability to encourage readers to approach the field of regulatory innovation. Estrid Sørensen, Science Studies Much hype has been generated about the importance of innovation for public and private sector organisations. Regulatory Innovation offers the first detailed study of regulatory innovation in a multiplicity of countries and domains. This book draws on in-depth studies of innovation in regulatory instruments and practices across high- and low-technology sectors, across different countries and from the early to the late 20th century. Highlighting different worlds of regulatory innovation those of the individual, the organization, the state, the global polity, and innovation itself, this book offers a fresh perspective and valuable insights for the practice and study of regulatory innovation. The explicit comparative focus of the case studies and the worlds of regulatory innovation approach make this book essential reading for academic researchers and students interested in regulation.

Author: Paul Nihoul
Publisher: Edward Elgar Publishing
ISBN: 1788972449
Category : Antitrust law
Languages : en
Pages : 421

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Book Description
Rapid technological innovations have challenged the conventional application of antitrust and competition law across the globe. Acknowledging these challenges, this original work analyses the roles of innovation in competition law analysis and reflects on how competition and antitrust law can be refined and tailored to innovation.

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235

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Book Description
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Author: Marcus Glader
Publisher: Edward Elgar Publishing
ISBN: 1847201687
Category : Law
Languages : en
Pages : 361

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Book Description
The book is warmly recommended to practitioners and academics from both the legal and the economic field. Guido Westkamp, Journal of Intellectual Property Law and Practice . . . Glader offers strong commentary and case explanation, coupled with insightful analysis, in this complex area. . . This book is strong on both the relevant law, and the economics arena in which the law must be applied, and deals equally well with the US and EC principles and practice. Mark Furse, European Competition Law Review The pace and scope of technological change is increasing, but some innovative technologies take years before they give rise to saleable products. Before they do, there is competition in ideas and research, but the ideas cannot be market tested, because there are no products or services to offer to consumers. Competition law, in Europe and the USA, cannot be applied to competition in research for innovation as if it was competition between products. Completely different problems arise and a completely different approach is needed. This book, the first on innovation markets, shows how this new approach has been used by competition authorities on both sides of the Atlantic in a wide variety of cases. It analyses in depth and detail the comparative law and economics of the problems arising from the different stages of these markets . It considers how far conclusions can be drawn about the future and comes to interesting, practical and sensible conclusions. And it avoids both unjustified scepticism and exaggerated enthusiasm about the theories of innovation markets. John Temple Lang, Cleary Gottlieb Steen & Hamilton LLP, Brussels and London; Trinity College Dublin, Ireland and Oxford University, UK This book examines the legal standards and their underlying economic rationale for the protection of competition in the innovation process, in both European competition law and American antitrust law. Apart from relevant regulatory frameworks, the author also reviews a range of case laws, which assess whether a transaction or unilateral conduct would limit market participants incentives and abilities for continued innovation and future competition. At the centre of this study is the innovation market concept. This concept entails the delineation, for purposes of antitrust analysis, of an upstream market for competing R&D. Questions of market definition, the assessment of innovation competition in defined markets, the role of efficiencies in the appraisal of transactions and possible remedies to alleviate anti-competitive effects are also explored. Updating the field of research in light of new developments and broadening and deepening the categorization and analysis of the innovation market area, this book will be of great interest to academics, practitioners and consultants, and also public policymakers.

Author: Minouche Shafik
Publisher: Princeton University Press
ISBN: 069120764X
Category : Business & Economics
Languages : en
Pages : 256

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Book Description
From one of the leading policy experts of our time, an urgent rethinking of how we can better support each other to thrive Whether we realize it or not, all of us participate in the social contract every day through mutual obligations among our family, community, place of work, and fellow citizens. Caring for others, paying taxes, and benefiting from public services define the social contract that supports and binds us together as a society. Today, however, our social contract has been broken by changing gender roles, technology, new models of work, aging, and the perils of climate change. Minouche Shafik takes us through stages of life we all experience—raising children, getting educated, falling ill, working, growing old—and shows how a reordering of our societies is possible. Drawing on evidence and examples from around the world, she shows how every country can provide citizens with the basics to have a decent life and be able to contribute to society. But we owe each other more than this. A more generous and inclusive society would also share more risks collectively and ask everyone to contribute for as long as they can so that everyone can fulfill their potential. What We Owe Each Other identifies the key elements of a better social contract that recognizes our interdependencies, supports and invests more in each other, and expects more of individuals in return. Powerful, hopeful, and thought-provoking, What We Owe Each Other provides practical solutions to current challenges and demonstrates how we can build a better society—together.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309124999
Category : Computers
Languages : en
Pages : 334

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Book Description
In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309292492
Category : Medical
Languages : en
Pages : 107

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Book Description
Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Author: Stephen Elstub
Publisher: Edward Elgar Publishing
ISBN: 1786433869
Category : Political Science
Languages : en
Pages : 621

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Book Description
Democratic innovations are proliferating in politics, governance, policy, and public administration. These new processes of public participation are reimagining the relationship between citizens and institutions. This Handbook advances understanding of democratic innovations, in theory and practice, by critically reviewing their importance throughout the world. The overarching themes are a focus on citizens and their relationship to these innovations, and the resulting effects on political equality. The Handbook therefore offers a definitive overview of existing research on democratic innovations, while also setting the agenda for future research and practice.