Law Commons^™

Patient Access In Fourteen High-Income Countries To New Antibacterials Approved By The Fda, Ema, Pmda, Or Health Canada, 2010-2020, Kevin Outterson, Ebiowei S F Orubu, Muhammad H. Zaman, John Rex, Christine Ardal

Faculty Scholarship

In 2010, the Infectious Diseases Society of America called for 10 new antibiotics by 2020 [1]. This goal was achieved in terms of the number of drug approvals, but actual patient access requires commercial launches in many countries, which itself requires sustainable commercial markets. Prior work has described limited access to new antibacterials in low- and middle-income countries (LMICs), in part due to the inability of many to afford these drugs [2]. This study examines patient access for new antibacterials in the G7 and 7 other high-income countries in Europe, to better understand other barriers to …

Designing A State Court Small Claims Odr System: Hitting A Moving Target In New York During A Pandemic, David Allen Larson

Faculty Scholarship

When I began helping the New York State Unified Court System design a pilot online dispute resolution (“ODR”) system back in October 2016, I never imagined more than four years would pass before a system was implemented. One reason our journey was so long is because our target kept moving. After completing a detailed credit card debt collection ODR platform, we had to change direction before implementation and focus instead on small claims cases. Then like the rest of the world, we suddenly had to deal with the COVID-19 pandemic. Although it took longer than anticipated, we achieved our goal …

Antibiotic Development & Economic, Regulatory And Societal Challenges, Kevin Outterson, Christine Årdal, Manica Balasegaram, Ramanan Laxminarayan, David Mcadams, John Rex, Nithima Sumpradit

Faculty Scholarship

Antibiotic resistance is undoubtedly one of the greatest challenges to global health, and the emergence of resistance has outpaced the development of new antibiotics. However, investments by the pharmaceutical industry and biotechnology companies for research into and development of new antibiotics are diminishing. The public health implications of a drying antibiotic pipeline are recognized by policymakers, regulators and many companies. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the national and international initiatives aimed at incentivizing research and the development of new antibiotics to improve the …

Can Nfl Players Obtain Judicial Review Of Arbitration Decisions On The Merits When A Typical Hourly Union Worker Cannot Obtain This Unusual Court Access?, Michael Z. Green, Kyle T. Carney

Faculty Scholarship

Several recent court cases, brought on behalf of National Football League (NFL) players by their union, the NFL Players Association (NFLPA), have increased media and public attention to the challenges of labor arbitrator decisions in federal courts. The Supreme Court has established a body of federal common law that places a high premium on deferring to labor arbitrator decisions and counseling against judges deciding the merits of disputes covered by a collective bargaining agreement (CBA). A recent trend suggests federal judges have ignored this body of law and analyzed the merits of labor arbitration decisions in the NFL setting.

NFL …

An International Legal Framework To Address Antimicrobial Resistance, Kevin Outterson, Steven J. Hoffman, John-Arne Rottingen, Otto Cars, Charles Clift, Fiona Rotberg, Göran Tomson, Anna Zorzet, Zain Rizvi

Faculty Scholarship

Antimicrobial resistance is a growing threat to global health. Currently it accounts for approximately 700,000 deaths annually, but is predicted to cause as many as 10,000,000 deaths by 2050 if nothing is done to address it. To effectively deal with this problem three areas must be addressed simultaneously: access, conservation, and innovation. However, solving issues of access, conservation and innovation at the same time requires new coordination and financing mechanisms, some of which must be organized globally. This bulletin outlines the possible role that a binding international legal framework can play in the fight against antimicrobial resistance.

Trial And Error: Lawyers And Nonlawyer Advocates, Anna E. Carpenter, Alyx Mark, Colleen F. Shanahan

Faculty Scholarship

Nonlawyer advocates are one proposed solution to the access to justice crisis and are currently permitted to practice in some civil justice settings. Theory and research suggest nonlawyers might be effective in some civil justice settings, yet we know very little, empirically, about nonlawyer practice in the United States. Using data from more than 5,000 unemployment insurance appeal hearings and interviews with lawyers and nonlawyers, this article explores how both types of representatives learn to do their work and what this means for their effectiveness. Building on recent research regarding the importance of procedural knowledge and relational expertise as elements …

Commentary, Critical Legal Theory In Intellectual Property And Information Law Scholarship, Cardozo Arts & Entertainment Law Journal Spring Symposium, Sonia K. Katyal, Peter Goodrich

Faculty Scholarship

The very definition and scope of CLS (critical legal studies) is itself subject to debate. Some scholars characterize CLS as scholarship that employs a particular methodology—more of a “means” than an “end.” On the other hand, some scholars contend that CLS scholarship demonstrates a collective commitment to a political end goal—an emancipation of sorts —through the identification of, and resistance to, exploitative power structures that are reinforced through law and legal institutions. After a brief golden age, CLS scholarship was infamously marginalized in legal academia and its sub-disciplines. But CLS themes now appear to be making a resurgence—at least in …

Expanding And Sustaining Clinical Legal Education In Developing Countries: What We Can Learn From South Africa, Peggy Maisel

Faculty Scholarship

Scholars have devoted considerable attention and resources to creating and expanding legal aid clinics, law school clinics, and university-based law clinics in order to make the law school experience more educational and relevant for law students in developing countries by introducing more skills training into the curriculum. Those who support the expansion of clinical legal education in South Africa and elsewhere have sought to achieve specific objectives related to improving legal education for students and providing assistance to economically disadvantaged groups.

Legal education is enhanced when it reflects the realities of the citizens within a country, such as South Africa …

Cancer And The Constitution: Choice At Life's End, George J. Annas

Faculty Scholarship

J. M. Coetzee's violent, anti-apartheid Age of Iron, a novel the Wall Street Journal termed “a fierce pageant of modern South Africa,” is written as a letter by a retired classics professor, Mrs. Curren, to her daughter, who lives in the United States. Mrs. Curren is dying of cancer, and her daughter advises her to come to the United States for treatment. She replies, “I can't afford to die in America. . . . No one can, except Americans.” Dying of cancer has been considered a “hard death” for at least a century, unproven and even quack remedies have been …

Fair Followers: Expanding Access To Generic Pharmaceuticals For Low- And Medium-Income Populations, Kevin Outterson

Faculty Scholarship

U.S. trade offi cials frequently employ the rhetoric of free riding and piracy when discussing intellectual property (IP) rights for medicines (Drahos with Braithwaite 2002; Benson 2005). The gentler term free rider is applied when developed country governments (OECD) use monopsony power to negotiate price discounts on patented pharmaceuticals (Outterson 2004, 2005b; U.S. Department of Commerce 2004; PhRMA 2005). Poorer governments usually lack suffi cient market power as a purchaser to negotiate discounts for their low- and middle-income populations. In these cases, governments and patients may resort to unlicensed generic drugs and compulsory licensing. In response, U.S. trade offi cials …

Copyright Law And Subject Matter Specificity: The Case Of Computer Software, Stacey Dogan, Joseph Liu

Faculty Scholarship

Drawing on recent work by Dan Burk and Mark Lemley in the patent context, this paper explores the extent to which courts have adapted pre-existing copyright doctrines to the special case of computer software. We argue that a number of courts have, as has been widely recognized, significantly adapted copyright doctrines to deal with special features of the computer software market. We further argue that these adaptations have, by and large, positively sought to strike a balance between the copyright act's dual goals of incentive and access. Despite this general trend toward adaptation, however, we point to a handful of …

Pharmaceutical Arbitrage: Balancing Access And Innovation In International Prescription Drug Markets, Kevin Outterson

Faculty Scholarship

While neoclassical economic theory suggests that arbitrage will undermine global differential pricing of pharmaceuticals, the empirical results are more complex. Pharmaceutical regulation, IP laws, global trade agreements, and company policies support differential pricing despite the pressure of arbitrage. For essential access programs in particular, the theoretical threat of pharmaceutical arbitrage is shown to be rarely observed empirically. Counterfeiting is demonstrated to be the more serious threat. These conclusions call for changes in the U.S. PEPFAR program for AIDS and in the implementation of the WTO TRIPS Agreement.

A more fundamental question, however, is whether pharmaceutical differential pricing is appropriate for …

Hipaa Regulations: A New Era Of Medical-Record Privacy?, George J. Annas

Faculty Scholarship

The new privacy regulations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) become effective April 14, 2003. This article outlines the implications of the new policy for practicing physicians. The regulations will affect virtually every physician, because they apply to any health care provider who conducts any business electronically, including billing. The regulations require health care providers to provide patients with a privacy notice that informs them who will have access to their records without their explicit consent and about patients' rights to inspect and amend their own records.

Common Law And Statutory Restrictions On Access: Contract, Trespass, And The Computer Fraud And Abuse Act, Maureen A. O'Rourke

Faculty Scholarship

Is copyright law relevant to the terms of access to information? Certainly, few would seriously contend that breaking into a locked filing cabinet to obtain access to a manuscript is not sanctionable, even if the intruder had some purpose that copyright law would applaud with respect to the information contained in the manuscript itself. Many instinctively believe that one must pay the asking price and respect the terms that accompany a copyrighted work or face the consequences under some set of laws like copyrights or contracts. In short, society likely generally believes that market forces regulate the conditions of access …

Minnesota Court Of Appeals Hears Oral Argument Via Interactive Teleconferencing Technology, Edward Toussaint

Faculty Scholarship

The Minnesota Court of Appeals is dedicated to providingaffordable access to the appellate process. Access to theappellate process is central to our vision. In order to promote this vision, the Minnesota Court ofAppeals has taken the initiative to implement Interactive VideoTeleconferencing ("IVT"). This essay will discuss the historybehind this decision, the mechanics of its implementation, andthe benefits and challenges of its application to the appellateprocess.

Is The Fourth Amendment Obsolete?–Restating The Fourth Amendment In Functional Terms, John M.A. Dipippa

Faculty Scholarship

No abstract provided.