The Law and Economics of Generic Drug Regulation 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 Law and Economics of Generic Drug Regulation PDF full book. Access full book title The Law and Economics of Generic Drug Regulation by Christopher Scott Hemphill. Download full books in PDF and EPUB format.
Author: Christopher Scott Hemphill
Publisher: Stanford University
ISBN:
Category :
Languages : en
Pages : 249
Get Book
Book Description
This dissertation examines the law and economics of generic drug entry, and the problems that arise from specific U.S. regulatory arrangements that govern innovation and competition in the market for patented pharmaceuticals. As Chapter 1 explains, competitive entry by generic drug makers is limited by both patents and industry-specific regulation, which together provide the means for brand-name drug makers to avoid competition and thereby recoup large investments in research, development, and testing. At the same time, the complex rules of the Hatch-Waxman Act furnish a pathway by which generic drug makers may challenge the validity or scope of brand-name patents, with a view to entering the market with a competing product prior to patent expiration. The subsequent chapters examine several aspects of the competitive interaction between brand-name and generic drug makers. Chapter 2 analyzes settlements of patent litigation between brand-name and generic drug makers, in which the brand-name firm pays the generic firm in exchange for delayed market entry. Such pay-for-delay settlements are an important, unresolved question in U.S. antitrust policy. The analysis reveals that the pay-for-delay settlement problem is more severe than has been commonly understood. Several specific features of the Act—in particular, a 180-day bounty granted to certain generic drug makers as an incentive to pursue pre-expiration entry—widen the potential for anticompetitive harm from pay-for-delay settlements, compared to the usual understanding. In addition, I show that settlements are "innovation inefficient" as a means of providing profits and hence ex ante innovation incentives to brand-name drug makers. To the extent that Congress established a preferred tradeoff between innovation and competition when it passed the Act, settlements that implement a different, less competition-protective tradeoff are particularly problematic from an antitrust standpoint. Chapter 3 synthesizes available public information about pay-for-delay settlements in order to offer a new account of the extent and evolution of settlement practice. The analysis draws upon a novel dataset of 143 such settlements. The analysis uncovers an evolution in the means by which a brand-name firm can pay a generic firm to delay entry, including a variety of complex "side deals" by which a brand-name firm can compensate a generic firm in a disguised fashion. It also reveals several novel forms of regulatory avoidance. The analysis in the chapter suggests that, as a matter of institutional choice, an expert agency is in a relatively good position to conduct the aggregate analysis needed to identify an optimal antitrust rule. Chapter 4 examines the co-evolution of increased brand-name patenting and increased generic pre-expiration challenges. It draws upon a second novel dataset of drug approvals, applications, patents, and other drug characteristics. Its first contribution is to chart the growth of patent portfolios and pre-expiration challenges. Over time, patenting has increased, measured by the number of patents per drug and the length of the nominal patent term. During the same period, challenges have increased as well, and drugs are challenged sooner, relative to brand-name approval. The analysis shows that brand-name sales, a proxy for the profitability of the drug, have a positive effect on the likelihood of generic challenge, consistent with the view that patents that later prove to be valuable receive greater ex post scrutiny. The likelihood of challenge also varies by patent type and timing of expiration. Conditional on sales and other drug characteristics, drugs with weaker patents, particularly those that expire later than a drug's basic compound patent, face a significantly higher likelihood of challenge. Though the welfare implications of Hatch-Waxman patent challenge provisions are complicated, these results suggest these challenges serve a useful purpose, in promoting scrutiny of low quality and late-expiring patents.
Author: Christopher Scott Hemphill
Publisher: Stanford University
ISBN:
Category :
Languages : en
Pages : 249
Get Book
Book Description
This dissertation examines the law and economics of generic drug entry, and the problems that arise from specific U.S. regulatory arrangements that govern innovation and competition in the market for patented pharmaceuticals. As Chapter 1 explains, competitive entry by generic drug makers is limited by both patents and industry-specific regulation, which together provide the means for brand-name drug makers to avoid competition and thereby recoup large investments in research, development, and testing. At the same time, the complex rules of the Hatch-Waxman Act furnish a pathway by which generic drug makers may challenge the validity or scope of brand-name patents, with a view to entering the market with a competing product prior to patent expiration. The subsequent chapters examine several aspects of the competitive interaction between brand-name and generic drug makers. Chapter 2 analyzes settlements of patent litigation between brand-name and generic drug makers, in which the brand-name firm pays the generic firm in exchange for delayed market entry. Such pay-for-delay settlements are an important, unresolved question in U.S. antitrust policy. The analysis reveals that the pay-for-delay settlement problem is more severe than has been commonly understood. Several specific features of the Act—in particular, a 180-day bounty granted to certain generic drug makers as an incentive to pursue pre-expiration entry—widen the potential for anticompetitive harm from pay-for-delay settlements, compared to the usual understanding. In addition, I show that settlements are "innovation inefficient" as a means of providing profits and hence ex ante innovation incentives to brand-name drug makers. To the extent that Congress established a preferred tradeoff between innovation and competition when it passed the Act, settlements that implement a different, less competition-protective tradeoff are particularly problematic from an antitrust standpoint. Chapter 3 synthesizes available public information about pay-for-delay settlements in order to offer a new account of the extent and evolution of settlement practice. The analysis draws upon a novel dataset of 143 such settlements. The analysis uncovers an evolution in the means by which a brand-name firm can pay a generic firm to delay entry, including a variety of complex "side deals" by which a brand-name firm can compensate a generic firm in a disguised fashion. It also reveals several novel forms of regulatory avoidance. The analysis in the chapter suggests that, as a matter of institutional choice, an expert agency is in a relatively good position to conduct the aggregate analysis needed to identify an optimal antitrust rule. Chapter 4 examines the co-evolution of increased brand-name patenting and increased generic pre-expiration challenges. It draws upon a second novel dataset of drug approvals, applications, patents, and other drug characteristics. Its first contribution is to chart the growth of patent portfolios and pre-expiration challenges. Over time, patenting has increased, measured by the number of patents per drug and the length of the nominal patent term. During the same period, challenges have increased as well, and drugs are challenged sooner, relative to brand-name approval. The analysis shows that brand-name sales, a proxy for the profitability of the drug, have a positive effect on the likelihood of generic challenge, consistent with the view that patents that later prove to be valuable receive greater ex post scrutiny. The likelihood of challenge also varies by patent type and timing of expiration. Conditional on sales and other drug characteristics, drugs with weaker patents, particularly those that expire later than a drug's basic compound patent, face a significantly higher likelihood of challenge. Though the welfare implications of Hatch-Waxman patent challenge provisions are complicated, these results suggest these challenges serve a useful purpose, in promoting scrutiny of low quality and late-expiring patents.
Author: Christopher Scott Hemphill
Publisher:
ISBN:
Category :
Languages : en
Pages :
Get Book
Book Description
This dissertation examines the law and economics of generic drug entry, and the problems that arise from specific U.S. regulatory arrangements that govern innovation and competition in the market for patented pharmaceuticals. As Chapter 1 explains, competitive entry by generic drug makers is limited by both patents and industry-specific regulation, which together provide the means for brand-name drug makers to avoid competition and thereby recoup large investments in research, development, and testing. At the same time, the complex rules of the Hatch-Waxman Act furnish a pathway by which generic drug makers may challenge the validity or scope of brand-name patents, with a view to entering the market with a competing product prior to patent expiration. The subsequent chapters examine several aspects of the competitive interaction between brand-name and generic drug makers. Chapter 2 analyzes settlements of patent litigation between brand-name and generic drug makers, in which the brand-name firm pays the generic firm in exchange for delayed market entry. Such pay-for-delay settlements are an important, unresolved question in U.S. antitrust policy. The analysis reveals that the pay-for-delay settlement problem is more severe than has been commonly understood. Several specific features of the Act--in particular, a 180-day bounty granted to certain generic drug makers as an incentive to pursue pre-expiration entry--widen the potential for anticompetitive harm from pay-for-delay settlements, compared to the usual understanding. In addition, I show that settlements are "innovation inefficient" as a means of providing profits and hence ex ante innovation incentives to brand-name drug makers. To the extent that Congress established a preferred tradeoff between innovation and competition when it passed the Act, settlements that implement a different, less competition-protective tradeoff are particularly problematic from an antitrust standpoint. Chapter 3 synthesizes available public information about pay-for-delay settlements in order to offer a new account of the extent and evolution of settlement practice. The analysis draws upon a novel dataset of 143 such settlements. The analysis uncovers an evolution in the means by which a brand-name firm can pay a generic firm to delay entry, including a variety of complex "side deals" by which a brand-name firm can compensate a generic firm in a disguised fashion. It also reveals several novel forms of regulatory avoidance. The analysis in the chapter suggests that, as a matter of institutional choice, an expert agency is in a relatively good position to conduct the aggregate analysis needed to identify an optimal antitrust rule. Chapter 4 examines the co-evolution of increased brand-name patenting and increased generic pre-expiration challenges. It draws upon a second novel dataset of drug approvals, applications, patents, and other drug characteristics. Its first contribution is to chart the growth of patent portfolios and pre-expiration challenges. Over time, patenting has increased, measured by the number of patents per drug and the length of the nominal patent term. During the same period, challenges have increased as well, and drugs are challenged sooner, relative to brand-name approval. The analysis shows that brand-name sales, a proxy for the profitability of the drug, have a positive effect on the likelihood of generic challenge, consistent with the view that patents that later prove to be valuable receive greater ex post scrutiny. The likelihood of challenge also varies by patent type and timing of expiration. Conditional on sales and other drug characteristics, drugs with weaker patents, particularly those that expire later than a drug's basic compound patent, face a significantly higher likelihood of challenge. Though the welfare implications of Hatch-Waxman patent challenge provisions are complicated, these results suggest these challenges serve a useful purpose, in promoting scrutiny of low quality and late-expiring patents.
Author:
Publisher: U.S. Government Printing Office
ISBN:
Category : Business & Economics
Languages : en
Pages : 94
Get Book
Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235
Get Book
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:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
Get Book
Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225
Get Book
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: Alison Masson
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 356
Get Book
Book Description
Author: Ernst R. Berndt
Publisher: University of Chicago Press
ISBN: 022661106X
Category : Business & Economics
Languages : en
Pages : 361
Get Book
Book Description
Personalized and precision medicine (PPM)—the targeting of therapies according to an individual’s genetic, environmental, or lifestyle characteristics—is becoming an increasingly important approach in health care treatment and prevention. The advancement of PPM is a challenge in traditional clinical, reimbursement, and regulatory landscapes because it is costly to develop and introduces a wide range of scientific, clinical, ethical, and socioeconomic issues. PPM raises a multitude of economic issues, including how information on accurate diagnosis and treatment success will be disseminated and who will bear the cost; changes to physician training to incorporate genetics, probability and statistics, and economic considerations; questions about whether the benefits of PPM will be confined to developed countries or will diffuse to emerging economies with less developed health care systems; the effects of patient heterogeneity on cost-effectiveness analysis; and opportunities for PPM’s growth beyond treatment of acute illness, such as prevention and reversal of chronic conditions. This volume explores the intersection of the scientific, clinical, and economic factors affecting the development of PPM, including its effects on the drug pipeline, on reimbursement of PPM diagnostics and treatments, and on funding of the requisite underlying research; and it examines recent empirical applications of PPM.
Author:
Publisher: World Health Organization
ISBN: 9240011870
Category : Business & Economics
Languages : en
Pages : 70
Get Book
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.
Author: Robin Feldman
Publisher: Cambridge University Press
ISBN: 131673949X
Category : Law
Languages : en
Pages : 165
Get Book
Book Description
While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.