Health Law and Policy Commons^™

Intellectual Property And Public Health - A White Paper, Ryan Vacca, James Ming Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, The University of Akron School of Law's Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants, and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

The Biologics Price Competition And Innovation Act: Is A Generic Market For Biologics Attainable?, Kasey E. Koballa

William & Mary Business Law Review

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated approval pathway for biological therapeutic products shown to be biosimilar to an FDA-approved biological reference product. The BPCIA purported to reduce the price of biologics while promoting innovation. In two recent cases, the Federal Circuit interpreted a key provision of the BPCIA requiring an applicant to provide the reference product sponsor with notice 180 days before marketing the product. The Federal Circuit’s interpretation extends the exclusivity period already provided for the reference product sponsor, deterring innovation and price reduction. Thus, the Supreme Court granted certiorari in one …

Too Clever By Half: Commanding The Nonuse Of State Authority To Regulate Health Benefits In The Aca, Michael F. Ryan

University of Massachusetts Law Review

Prior to the enactment of the Patient Protection and Affordable Care Act (ACA), state legislatures routinely passed laws requiring health insurance carriers to cover certain health care services or providers. At the behest of the insurance industry, Congress attempted to use the health reform law as a vehicle to reign in state-specific “mandated benefit” laws. That being said, the ACA does not prevent states from enacting mandated benefit laws; in fact, the statute expressly permits states to enact such laws. Instead, Congress created a significant barrier to continued state-specific regulation of health insurance benefits. Specifically, 42 U.S.C. § 18031(d)(3)(B)(ii) (Section …

Can They Do That?: The Limits Of Governmental Power Over Medical Treatment, Paul Jerome Mclaughlin Jr.

Library Faculty Publications

The government’s power over health care is strongest when health care treatments and precautions to protect the public welfare, such as quarantines and vaccinations, are at issue. Governmental power over health care decisions weakens when an individual’s health care decisions are in question. When health care decisions would only affect the individual making them, the government’s power is even less. This article argues that government agents must be cautious in making health care determinations for others and that they should aim to protect an individual’s right to self-determination so long as those choices do not pose a threat to the …

Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley

Articles

In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have all been discussed as alternatives to paying strictly for volume. Manufacturers and payers have complained, however, that Medicaid’s “best-price rule” inhibits their ability to enter into these newpricing arrangements. This article examines the best-price rule and assesses to what extent, if any, it might frustrate the goal of paying for value. We conclude that the best-price rule is not as serious a problem as it …

Legal Capacities Required For Prevention And Control Of Noncommunicable Diseases, Roger S. Magnusson, Benn Mcgrady, Lawrence O. Gostin, David Patterson, Hala Abou Taleb

Georgetown Law Faculty Publications and Other Works

Law lies at the centre of successful national strategies for prevention and control of noncommunicable diseases. By law we mean international agreements, national and subnational legislation, regulations and other executive instruments, and decisions of courts and tribunals. However, the vital role of law in global health development is often poorly understood, and eclipsed by other disciplines such as medicine, public health and economics. This paper identifies key areas of intersection between law and noncommunicable diseases, beginning with the role of law as a tool for implementing policies for prevention and control of leading risk factors. We identify actions that the …

Zika, Pregnancy, And The Law, Sam F. Halabi

Arkansas Law Review

The public health emergency surrounding the spread of the Zika virus has resurrected and brought into sharp relief some of the most vexing questions surrounding the relationship between pregnancy and law: the appropriate circumstances, if any, in which fetal tissue research is permissible; when and how the government may sponsor statements intended to influence reproductive decisions; and how to balance the health and rights of both women and their unborn children when health threats target both.

Vaccine Licensure In The Public Interest: Lessons From The Development Of The U.S. Army Zika Vaccine, Ana Santos Rutschman

All Faculty Scholarship

Vaccines developed by the public sector are key to preventing future outbreaks of infectious diseases. However, the licensure of these vaccines to private-sector companies under terms that do not ensure both their availability and affordability compromises their development. This Essay analyzes the recent attempted licensing deal for a Zika vaccine between the U.S. Army and Sanofi, a French pharmaceutical company. The proposed grant of an exclusive license to Sanofi triggered widespread concern because none of its substantive terms were disclosed. While § 209 of the Patent Act imposes limitations on exclusive licensure, the Army released no information supporting its finding …

Sb 201 - Sick Leave, Mary Elizabeth D. Steinhaus, Chadwick L. Williams

Georgia State University Law Review

The Act amends Georgia’s general provisions relating to labor and industrial relations by adding a new provision that requires qualifying employers to allow their employees to use sick leave to care for immediate family members.

Sb 104 - Carjacking, Fentanyl And "Upskirting", Katherine H. Krouse, Lauren R. Light

Georgia State University Law Review

The Act includes various amendments to Georgia’s criminal code. Three changes are most notable. First, the Act designates the offense of hijacking a motor vehicle as hijacking a motor vehicle in the first degree and creates the offense of hijacking a motor vehicle in the second degree. Second, the Act criminalizes the use of a device to film underneath or through an individual’s clothing. Lastly, the Act adds the drug Fentanyl and its various analogs to the list of controlled substances.

Hb 249 - Controlled Substances And Prescription Drug Monitoring Database, Emily R. Polk, Brandon M. Reed

Georgia State University Law Review

The Act amends Georgia’s controlled-substances statutes to expand medical provider requirements to record prescription drug information in an electronic prescription drug monitoring program database (PDMP). Medical providers are now required to use the PDMP to enter information about their prescription of certain types and quantities of opioids. The purpose of the act is to fight Schedule II opioid abuse throughout the state of Georgia. A medical provider’s failure to report required information is reported to his or her respective state regulatory board for possible reprimand. In addition to mandatory reporting, the Act includes various other provisions related to regulating opioid …

Hb 359 - Power Of Attorney, Roma A. Amin, Catherine V. Schutz

Georgia State University Law Review

The bill would have repealed and replaced Georgia’s Power of Attorney for the Care of a Minor Child Act. The category of people who could be given power of attorney for the care of a minor child would have expanded from only grandparents and great-grandparents to a broad category of the child’s relatives, and anyone associated with a non-profit organization focused on child or family services or a licensed child-placing agency.

Will The Zika Virus Enable A Transplant Of Roe V. Wade To Brazil?, Amanda Greenberg

University of Miami Inter-American Law Review

No abstract provided.

Localism, Labels, And Animal Welfare, Samuel R. Wiseman

Northwestern Journal of Law & Social Policy

The law does relatively little to improve the welfare of animals raised for food. In the short term, at least, market-based solutions appear to have more promise as a means of promoting farm animal welfare, as consumers increasingly seek out local and humanely-raised meat and eggs. To aid consumers in identifying these products, certification systems of varying degrees of rigor exist, but even these are of little use to consumers in the restaurant context, which accounts for a large percentage of meat consumption. Patrons see only finished meals, making fraud difficult to detect, and a recent newspaper investigation suggests that …

Political Rhetoric And Minority Health: Introducing The Rhetoric-Policy-Health Paradigm, Kimberly Cogdell Grainger

Saint Louis University Journal of Health Law & Policy

Rhetoric is a persuasive device that has been studied for centuries by philosophers, thinkers, and teachers. In the political sphere of the Trump era, the bombastic, social media driven dissemination of rhetoric creates the perfect space to increase its effect. Today, there are clear examples of how rhetoric influences policy. This Article explores the link between divisive political rhetoric and policies that negatively affect minority health in the U.S. The rhetoric-policy-health (RPH) paradigm illustrates the connection between rhetoric and health. Existing public health policy research related to Health in All Policies and the social determinants of health combined with rhetorical …

The Burden Of A Good Idea: Examining The Impact Of Unfunded Federal Regulatory Mandates On Medicare Participating Hospitals, Rachel Juhas Suddarth

Law Faculty Publications

Health care costs are on the rise. In 1960, the United States spent $9 billion on hospital care. Since then, hospital related spending has grown exponentially. In 2015, the United States spent over $1 trillion on hospital care, with $359.9 billion of those payments coming from the federal Medicare program for the aged and disabled. Researchers have long tried to understand the exact causes of rising health care costs. While many have closely examined the costs associated with population demographics, medical innovation, prescription drug costs, overutilization of services, and fraud or abuse, there is one driving force that does not …

Independence Is The New Health, Laura D. Hermer

Faculty Scholarship

Medicaid plays key roles in supporting our nation’s health. Under the Affordable Care Act, Medicaid took an even more central position in public health endeavors by extending coverage in all interested states to millions of adults who typically fell through the health care cracks. Nevertheless, the Trump administration is now undoing these gains by actively encouraging states to curtail access to Medicaid in key respects while using the rhetoric of health.

This article examines Trump administration efforts in two contexts: (1) state § 1115 waiver applications seeking to better align their Medicaid programs with cash welfare and food stamp programs, …

Regulation Of Radioactive Fracking Waste, Elizabeth Ann Glass Geltman, Nichole Leclair

Publications and Research

Natural gas extracted form shale reached record production totals in 2015 in the United States and the US Energy Information Administration (EIA) forecasts natural gas production will continue to increase. Wastes from shale gas extraction can contain the radioactive isotopes radium-226 (Ra-226) and radium-228 (Ra-228), which decay further into radon (Rn). Exposure to radon, a form of naturally occurring radioactive materials (NORM), is the leading cause of lung cancer in the United States, after smoking. This article explores how states handle the disposal of technologically enhanced naturally occurring radioactive materials (TENORM) and/or NORM waste from oil and gas operations to …

2018 Legal Update: Npdb Reporting, Retaliation, Physician Well Being, And Medical Staff Litigation, Preparing For A Successful Judicial Review Hearing, Rick D. Barton, Natalie V. Mueller

Center for Health Law Policy and Bioethics

No abstract provided.

Clearly Unconvincing: How Heightened Evidentiary Standards In Judicial Bypass Hearings Create An Undue Burden Under Whole Woman's Health, Haley Hawkins

American University Law Review

No abstract provided.

Foreword, Adrienne A. Testa

Annals of Health Law and Life Sciences

No abstract provided.

Sovaldi: The High Price For A Cure, Theresa C. Mahfood

Annals of Health Law and Life Sciences

No abstract provided.

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

Uncanny Commodities: Policy And Compliance Implications For The Trade In Debt And Health Data, Mary F E Ebeling

Annals of Health Law and Life Sciences

No abstract provided.

Remarks On Patient Privacy: Problems, Perspectives, And Opportunities, Stacey A. Tovino

Annals of Health Law and Life Sciences

No abstract provided.

The International Right To Health Care: A Legal And Moral Defense, Michael Da Silva

Michigan Journal of International Law

In the following, I outline the case against the international right to health care and explain why recognition of such a right is still necessary. The argument is explicitly limited to international human rights law and is primarily descriptive in nature, but I go on to explain the moral reasons to accept this account. Both the positive law and moral reasoning could be used in other health rights debates, but I do not attempt to make such claims here.

The structure of my work is as follows. I first outline three problems with recognizing an international right to health care. …

Let Your Conscience Be Your Guide: Comparing And Contrasting Washington's Death With Dignity Act And Pharmacy Regulations After The Ninth Circuit's Decision In Stormans, Inc. V. Wiesman, Jared B. Magnuson

Georgia Law Review

In 2015, the Ninth Circuit held in Stormans, Inc. v.
Wiesmani that the Christian owners of a pharmacy in
Washington who objected to carrying and distributing
emergency contraception because it conflicted with their
religious beliefs must distribute those drugs under the
state's pharmacy regulations. Washington's
Pharmacist Responsibility Rule and Delivery Rule
require pharmacy owners to carry and distribute
emergency contraception but do not allow any
exemptions for owners or pharmacists who object to
doing so for conscience reasons. At the same time,
Washington's Death with Dignity Act makes physician-
assisted suicide legal in the state and contains a broad
exemption …

The Morality Of Compulsory Licensing As An Access To Medicines Tool, Margo A. Bagley

Faculty Articles

This Article contemplates the validity of theft rhetoric in relation to the right of countries to grant compulsory licenses from an unconventional perspective; that of biblical teachings on what it means to steal.

Part I describes the use of theft rhetoric in relation to IP infringement broadly and drug-patent compulsory licenses in particular.

Part II challenges the contention, suggested by theft rhetoric, that compulsory licenses are morally wrong as a form of stealing, by considering the meaning of theft in the context of its Judeo-Christian origins.

Part III considers the cogency of the accusation that the issuance of compulsory licenses …

Removing Obstacles To A Peaceful Death, Kathy L. Cerminara, Barbara A. Noah

Faculty Scholarship

We all will die, but the American health care system often impedes a peaceful death. Instead of a quiet death at home surrounded by loved ones, many of us suffer through overutilization of sometimes-toxic therapeutic interventions long past the time when those interventions do more good than harm. This article proposes revisions to health professional training and payment policy to eliminate as much as possible physical and existential suffering while progressing through the terminal phase of illness. The solution lies in seamless progression from treatment with integrated palliative care to hospice before death, but provider attitudes and payor practices must …

Increasing Vaccination Rates Without Eliminating Nonmedical Exemptions, Hillel Y. Levin, Timothy D. Lytton

Popular Media

This essay on shifting states' incentives to reduce nonmedical exemptions while respecting the choice not to vaccinate, is based on a forthcoming article, A Model Law for Nonmedical Immunization Exemptions Using the Least Restrictive Means, coauthored by Daniel A. Salmon, Stacie Kershner, Timothy D. Lytton, Hillel Y. Levin, Claire Hannan, and Saad B. Omer.