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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.
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.
The field of HCV has changed perhaps faster than any other field in medicine. The Guest Editors have strived to create an issue that is a state-of-the-art analysis of solutions to specific challenges faced in the United States and globally in implementing HCV elimination strategies. They believe that clinicians now have the tools and road maps needed to accomplish this goal. The clinical review articles in this issue accomplish that: Using Existing Health Care Infrastructure To Expand HCV Care; Creating A Reproducible Health Economic Model To Describe The Burden Of HCV And Cost Of Treatment In Any Country; The Best Uses Of Cost-Effectiveness Models In HCV; Increasing Access To HCV Care In Corrections; Cure As Prevention Strategies For HCV In People Who Inject Drugs; Australia Will Eliminate HCV – How It Works; New York Is The First State In The US To Develop An HCV Elimination Strategy; When HCV Diagnostics Are The Barrier To Care; Key Findings From The Checs HCV Cohort Study; Strategies To Reduce HCV Reinfection Rates In People Who Inject Drugs; Strategies To Reduce HCV Reinfection Rates In Men Who Have Sex With Other Men; The Value Of Curing HCV From A Payer’s Perspective; How To Expand Care Capacity In HCV; Strategies To Eliminate HCV In The HIV Coinfected Population; and The US Veteran’s Administration: Lessons Learned And Best Practices For HCV Elimination.
This Element explains how corporate financialization,through predatory value extraction, undermines investment in innovation in the US.
Why is America's health care system so expensive? Why do hospitalized patients receive bills laden with inflated charges that com out of the blue from out-of-network providers or demands for services that weren't delivered? Why do we pay $600 for EpiPens that contain a dollar's worth of medicine? Why is more than $1 trillion - one out of every three dollars that passes through the system - lost to fraud, wasted on services that don't help patients, or otherwise misspent? Overcharged answers these questions. It shows that America's health care system, which replaces consumer choice with government control and third-party payment, is effectively designed to make health care as expensive as possible. Prices will fall, quality will improve, and medicine will become more patient-friendly only when consumers take charge and exert pressure from below. For this to happen, consumers must control the money. As Overcharged explains, when health care providers are subjected to the same competitive forces that shape other industries, they will either deliver better services more cheaply or risk being replaced by someone who will.
THE PHARMACEUTICAL INDUSTRY IS BROKEN From the American hedge fund manager who drastically hiked the price of an AIDS pill to the children’s cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system built to drive innovation and improve patient care has been distorted to maximise profits. In Sick Money, the investigative journalist who exposed a billion-pound British price-hiking scandal goes inside the global battle over high drug prices. From secret deals to patients forced to turn to the black market, Billy Kenber reveals how medicines have become nothing more than financial assets. He offers a diagnosis of an industry in crisis - and a prescription for how it could be fixed.
Hepatitis B and C cause most cases of hepatitis in the United States and the world. The two diseases account for about a million deaths a year and 78 percent of world's hepatocellular carcinoma and more than half of all fatal cirrhosis. In 2013 viral hepatitis, of which hepatitis B virus (HBV) and hepatitis C virus (HCV) are the most common types, surpassed HIV and AIDS to become the seventh leading cause of death worldwide. The world now has the tools to prevent hepatitis B and cure hepatitis C. Perfect vaccination could eradicate HBV, but it would take two generations at least. In the meantime, there is no cure for the millions of people already infected. Conversely, there is no vaccine for HCV, but new direct-acting antivirals can cure 95 percent of chronic infections, though these drugs are unlikely to reach all chronically-infected people anytime soon. This report, the first of two, examines the feasibility of hepatitis B and C elimination in the United States and identifies critical success factors. The phase two report will outline a strategy for meeting the elimination goals discussed in this report.
Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.
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.