Law Commons^™

Stumbling Over Trips: The International Intellectual Property Waiver Petition And The U.S. Executive, Jordan Paradise, Christina Conroy

Faculty Publications & Other Works

This article examines the relationship among intellectual property (IP) law protections; United States (U.S.) and international law and policy; and the actualization of diagnostics, drugs, and vaccines in the time of the COVID-19 coronavirus. Two key international treaties that relate to IP law--The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) - establish international norms for the protection of IP. Core aspects of each of these treaties are described along with the role of the World Trade Organization (WTO) and concepts of compulsory licensing. As a result …

Stumbling Over Trips: The International Intellectual Property Waiver Petition And The U.S. Executive, Jordan Paradise, Christina Conroy

Faculty Publications & Other Works

This article examines the relationship among intellectual property (IP) law protections; United States (U.S.) and international law and policy; and the actualization of diagnostics, drugs, and vaccines in the time of the COVID-19 coronavirus. Two key international treaties that relate to IP law--The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) - establish international norms for the protection of IP. Core aspects of each of these treaties are described along with the role of the World Trade Organization (WTO) and concepts of compulsory licensing. As a result …

Biosimilar Bias: A Barrier To Addressing American Drug Costs, Cynthia M. Ho

Faculty Publications & Other Works

Forty percent of spiraling US drug costs are based on a mere two percent of all drugs –biologic drugs (biologics) made from living cells that are administered by injection or infusion. These costs will continue to balloon as new biologics are approved; the recently approved Alzheimer’s drug is expected to result in a 50% increase in Medicare spending and cost individuals 40% of their annual income. These drugs are expensive because they cannot be mass-produced, and their cost places important treatments for conditions such as arthritis (Humira) and cancer (Herceptin) out of reach for many Americans. Fortunately, just as there …

Ai's Legitimate Interest: Towards A Public Benefit Privacy Model, Charlotte A. Tschider

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Health data uses are on the rise. Increasingly more often, data are used for a variety of operational, diagnostic, and technical uses, as in the Internet of Health Things. Never has quality data been more necessary: large data stores now power the most advanced artificial intelligence applications, applications that may enable early diagnosis of chronic diseases and enable personalized medical treatment. These data, both personally identifiable and de-identified, have the potential to dramatically improve the quality, effectiveness, and safety of artificial intelligence.

Existing privacy laws do not 1) effectively protect the privacy interests of individuals and 2) provide the flexibility …

Tobacco Product Warnings In The Mist Of Vaping: A Retrospective On The Public Health Cigarette Smoking Act, John D. Blum

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Warning labels have been mandated for cigarette packages under US federal law since the mid-1960s. While the nature and specificity of warnings has evolved, there is a long-standing skepticism about the effectiveness of textual warning labels, which has spurred the global use of pictorial warnings as a deterrent mechanism. Due to commercial speech challenges, the USFDA has delayed adoption of graphic cigarette labels, and the impact of pending, newly revised graphic warnings remains a matter of uncertainty. Like other matters of smoking abatement, public health anti-tobacco initiatives are compounded by the rapid increase in e-cigarette use where currently, mandatory warnings …

The Healthcare Privacy-Artificial Intelligence Impasse, Charlotte A. Tschider

Faculty Publications & Other Works

With the advent of the Internet, wireless technologies, advanced computing, and, ultimately, the integration of mobile devices into patient care, medical device technologies have revolutionized the healthcare sector. What once was a highly personal, one-to-one relationship between physician and patient has now been expanded, including medical device manufacturers, third party healthcare system providers, even physician-as-a-service for interpreting the data complex systems churn out. The introduction of technology to the healthcare field has, at an ever-increasing rate, transformed human health management.

Reworking privacy commitments in an AI world is an important endeavor. It may mean that we reconceptualize what these rights …

A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho

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This Article argues that pharmaceutical marketing to doctors should be more critically evaluated and entitled to less First Amendment protection, contrary to a trend dating back to the Supreme Court's 2011 decision in Sorrell. In particular, the Article argues that more information to doctors in the form of pharmaceutical marketing does not necessarily result in better patient outcomes. The Article adds a significant critique based on the existence and impact of cognitive bias literature that has thus far not been recognized in this area. If courts fully embrace this understanding, they should recognize that the government, through the Food and …

Public Health Preparedness & Response: An Exercise In Administrative Law, John D. Blum, Jordan Paradise

Faculty Publications & Other Works

Responses to epidemics, pandemics, and other biological disasters require multiple coordinated initiatives that combine sophisticated planning, sound emergency management, effective stockpiles, solid geographic information systems, well-developed laboratory surveillance and response, and effective management capabilities. Critical to the noted elements of planning and response is the existence of a legal structure, which underpins the operations of necessary programs. While the law may not be the first public health tool considered in a disaster, it is fundamental to the effective functioning of multiple actors and must be harmonized across jurisdictional lines. This article explores the role of law in pandemics and other …

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

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No abstract provided.

Health Care Is Not A Typical Consumer Good And We Should Not Rely On Incentivized Consumers To Allocate It, Lawrence E. Singer

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No abstract provided.

How Much Of Health Care Antitrust Is Really Antitrust?, Spencer Weber Waller

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No abstract provided.

A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise

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No abstract provided.

Drugged Out: How Cognitive Bias Hurts Drug Innovation, Cynthia M. Ho

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No abstract provided.

Should All Drugs Be Patentable?: A Comparative Perspective, Cynthia M. Ho

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Although there has been substantial discussion of the proper scope of patentable subject matter in recent years, drugs have been overlooked. This Article begins to address that gap with a comparative perspective. In particular, this Article considers what is permissible under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as how India and Canada have utilized TRIPS flexibilities in different ways to properly reward developers of valuable new drugs, while also considering the social harm of higher prices beyond an initial patent term on drugs.

This Article brings valuable insight into this area at a critical …

Forward Special Edition: “Innovations In Public Health Law: Exploring New Strategies”, Lawrence E. Singer

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No abstract provided.

The Naprapath In The Rainforest, John D. Blum

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No abstract provided.

Informed Consent Beyond The Physician-Patient Encounter: Tort Law Implications Of Extra-Clinical Decision Support Tools., Nadia N. Sawicki

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No abstract provided.

Symposium: Theory And Praxis In Reducing Women’S Poverty, Annette Appell, Emily Benfer, Davida Finger

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No abstract provided.

Health Justice Project: A Collaborative Commitment To Solving Real World Problems, Emily Benfer

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No abstract provided.

Medicaid Governance In The Wake Of National Federation Of Independent Business V. Sebelius: Finding Federalism's Middle Pathway, From Administrative Law To State Compacts., John D. Blum, Gayland O. Hethcoat Ii

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No abstract provided.

Advancing Health Law & Social Justice In The Clinic, The Classroom And The Community, Emily Benfer, John Ammann, Lisa Bliss, Sylvia Caley, Robert Pettignano, Elizabeth Tobin Tyler

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No abstract provided.

Global Access To Medicine: The Influence Of Competing Perspectives., Cynthia M. Ho

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No abstract provided.

The Abortion Informed Consent Debate: More Light, Less Heat., Nadia N. Sawicki

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No abstract provided.

Reforming Health Reform: Revisiting The Process Of Governance, John D. Blum

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No abstract provided.

The Quagmire Of Hospital Governance., John D. Blum

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No abstract provided.

Variables Of Health Reform And Their Impacts On The Elderly., John D. Blum

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No abstract provided.

Finding A New Regulatory Pathway For The Old Labyrinth Of Health Planning., John D. Blum

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No abstract provided.

Bending The Arc, Emily Benfer

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No abstract provided.

Health Reform’S Newest Moment In Time, John D. Blum

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No abstract provided.

Erisa, Agency Costs, And The Future Of Healthcare In The United States Erisa, Agency Costs, And The Future Of Healthcare In The United States, John Bronsteen

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No abstract provided.