Health Law and Policy Commons^™

Recent Changes In Discretionary Denials Of Drug Patent Challenges, S. Sean Tu, Arti K. Rai, Aaron S. Kesselheim

Faculty Scholarship

Recent policy shifts at the U.S. Patent and Trademark Office (USPTO) have sharply limited the use of two administrative pathways for patent reviews, inter partes review (IPR) and post-grant review (PGR). Congress created these administrative pathways to provide a faster and less costly way to challenge weak patents. Recently, the USPTO has expanded the use of “discretionary denials,” invoking a new “settled expectations” rationale that blocks IPR petitions for patents more than about six years old. From May to September 2025, 60% of 506 requests for discretionary denial were granted, triple historical levels, including one-third involving drug patents. These changes …

Birth On Mother Earth: Mitigating The Maternal Health Crisis, Jill C. Engle

Faculty Scholarship

Maternal health outcomes in the U.S. are remarkably poor, especially when compared to those in other industrialized countries. For example, our maternal death rate is more than twice that of Canada’s. Women of color in the U.S. suffer maternal morbidity and mortality at rates considerably higher than white women. Indigenous women experience the worst maternal health outcomes of all. Yet, most maternal deaths and injuries are preventable. Furthermore, rates of maternal harm, including death, are lower when midwives and similar birthing attendants are involved. This Article is the first to fully explore the unique skillset of traditional birth attendants (TBAs). …

Moral Politics Theory Applied To Abortion: Utopias, Dystopias, And Dobbs, Susan Ayres

Faculty Scholarship

This article examines Moral Politics Theory (MPT) as a way to understand current tensions in the US concerning reproductive justice. MPT, as developed and researched for over thirty years by cognitive scientist, George Lakoff, provides a way to explain differences in political worldviews. According to Lakoff’s research in Moral Politics and Don’t Think of an Elephant!, conservatives tend to hold a strict-father model, and progressives hold a nurturant-parent model. People in the political middle tend to endorse both models; Lakoff labels those in the middle as “biconceptuals,” and discusses how this group is most susceptible to persuasion because metaphors frame …

The United States Healthcare System: From Medicare To Post-Pandemic Health Policy, William M. Sage

Faculty Scholarship

My purpose in this essay is to comment on national health policy in the United States over the past sixty years.  My conclusions are less optimistic than what I had hoped when I began my teaching and research career in the 1990s to be able to say in 2025.  In particular, the successful expansion of publicly supported health coverage via the passage of the Affordable Care Act (“ACA” or “Obamacare”) in 2010 seems to have triggered -- though I hesitate to say that it caused – a backsliding from broader commitments to clinical performance, population health, and social solidarity that …

Make America Healthy: Reducing High Pharmaceutical Prices Without Reducing Innovation, Srividhya Ragavan

Faculty Scholarship

Cost of medication in the United States has historically remained one of the highest in the world. The conundrum that the United States has faced in balancing innovation with affordability of life-saving medications is palpable, especially when faced with the reality of patent monopolies conflicting with healthcare obligations. The result is an overflow of issues, which emphasize the need to delineate limits on innovation to balance pharmaceutical novelty with robust public health within the United States. This has increasingly shifted the focus of patent law into the realm of healthcare issues. Naturally, it leads to an inquiry about how best …

China, The Trips Waiver, And The Global Pandemic Response, Peter K. Yu

Faculty Scholarship

This chapter identifies three distinct reasons why China took a middle-of-the-road position in the debate on the COVID-19 TRIPS waiver at the WTO. It also recounts the country’s more assertive position in the run-up to the adoption of the Ministerial Decision on the waiver. Drawing eight lessons from the international debate on the waiver and the subsequent Ministerial Decision, the chapter offers insights into the future role China can or will play in future international policy debates at the intersection of intellectual property and public health, including during the next pandemic.

Health Law And Democracy, Wendy K. Mariner

Faculty Scholarship

Current political divisions are destabilizing existing laws affecting the health field. Major changes in the field of health law have one thing in common: changes in who holds political power ‒ Congress and state legislatures, governors, presidents, judges, and agency officials. The laws that structure financial, economic, educational, and health care systems, environmental conditions, and civil society are primarily the product of elections that populate our political institutions. These structural determinants of health in turn create laws that influence how ‒ and how well ‒ we live and whether our society functions fairly under the rule of law. Thus, who …

Transplantation And Immortality: A Selective History Of Boston University’S Center For Health Law, Ethics & Human Rights, George J. Annas

Faculty Scholarship

The celebration of the anniversary of the Center for Health Law, Ethics & Human Rights (the “Center”) provides an opportunity to reflect on what defines the field of health law, as well as its conjoined twins of bioethics and human rights. The related fields are vast, and the subjects they encompass are ever-expanding. It is probably impossible to lay out a summary that does justice to their expansive, interdisciplinary scope. Instead, my discussion of the Center examines a subject that barely existed when the Center was formed in 19581 and that continues to make headlines more than sixty–six years later …

Just Fix The Damn Payment System!, Frances H. Miller

Faculty Scholarship

This piece takes as a given that we are stuck with our fragmented, inefficient, multi-payor health care system for at least the short run. It then analyzes the deficiencies of three payment mechanisms whereby regulators (including Congress) have invited private sector providers to help ameliorate perceived problems. The first concerns an inadequate supply of nursing home beds in the early ‘70s, the next focuses on Medicare Advantage as a supposedly superior cost containment alternative to traditional Medicare, and the final one involves the ‘devil’s bargain’ struck with the pharmaceutical industry to get prescription drug coverage added to Medicare. All three …

Common Measures Of Vaccination Intention Generate Substantially Different Estimates That Can Reduce Predictive Validity, Jessica Fishman, K. Aleks Schaefer, Daniel Scheitrum, Christopher Robertson, Dolores Albarracin

Faculty Scholarship

Surveys often estimate vaccination intentions using dichotomous ("Yes"/"No") or trichotomous ("Yes," "Unsure," "No") response options presented in different orders. Do survey results depend on these variations? This controlled experiment randomized participants to dichotomous or trichotomous measures of vaccine intentions (with “Yes” and “No” options presented in different orders). Intentions were measured separately for COVID-19, its booster, and influenza vaccines. Among a sample of U.S. adults (N = 4,764), estimates of vaccine intention varied as much as 37.5 ± 17.4 percentage points as a function of the dichotomous or trichotomous response set. Among participants who had not received the COVID-19 vaccine, …

Intellectual Property, Genetic Resources, And Associated Traditional Knowledge, N.S. Gopalakrishnan, Srividhya Ragavan, Narendran Thiruthy

Faculty Scholarship

The recently concluded WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge mandates disclosure requirements in patent applications, thereby creating an obligation to attribute the use of genetic resources and traditional knowledge. The WIPO member countries thus have an opportunity to modify their national patent laws, so that they can effectively control genetic resources and traditional knowledge. This article examines the choices that the biodiversity-rich countries have when designing their national legal systems to implement the treaty.

Changes In Revenues Associated With Antimicrobial Reimbursement Reforms In Germany, Matt Mcenany, Kevin Outterson

Faculty Scholarship

Policy declarations from the G7 and other high-level meetings call for increased incentives for antimicrobial research and development (R&D). Governments fund push incentives like CARB-X and GARDP, and G7 countries are now designing pull incentives—financial rewards given to manufacturers post-market authorization that are intended to encourage the creation and introduction of novel antimicrobials. Germany has declared previously at the G7 that it has developed a pull incentive that will increase revenues from sales of important new antimicrobials, principally by exempting them from some aspects of health technology benefit assessments and reference pricing, which should result in higher prices. This policy …

Why Mlp Legal Care Should Be Financed As Health Care, William M. Sage, Keegan D. Warren

Faculty Scholarship

Medical-legal partnership (MLP) integrates the unique expertise of lawyers into collaborative clinical environments. MLP teams meet the needs of individual patients while also detecting structural problems at the root of health inequities and advancing solutions at the institutional, community, and system levels. Yet MLPs today operate in limited settings and survive on scant budgets. Expanding their impact requires secure funding. Financing MLPs as health care can do the following: (1) help address inequity at the point of care; (2) enable expert diagnosis and treatment of nonmedical drivers of health; (3) enhance team-based practice in health care organizations; (4) offer another …

The Limits Of Immigrant Resilience, Huyen Pham, Natalie C. Cook, Ernesto Amaral, Raymond Robertson, Suojin Wang

Faculty Scholarship

Economists have identified important adaptations that immigrant workers have made to weather economic crises. During times of economic contraction, immigrant workers have moved across industries or geographical locations, downshifted to part-time work, and accepted lower wages to stay employed. Evidence from the Great Recession (2007–2009) shows the benefits of that economic resilience: immigrant workers were more likely than native-born workers to remain continuously employed, to have shorter periods of unemployment when they lost their jobs, and to regain jobs more quickly in the recovery period. Of course, these adaptations had significant personal costs for immigrant workers and their families, but …

The States' Hodgepodge Of Physician Licensure Regulations, Tara Sklar, Christopher Robertson

Faculty Scholarship

The end of the federal COVID-19 public health emergency (PHE) on May 11, 2023, marked a pivotal shift in the landscape of telehealth regulation in the US. Kwan, Jolin, and Shachar analyze the implications of this transition by exposing inconsistencies in access to care. We agree that we now face a “convoluted patchwork of permanent and temporary changes to telehealth law and policy.”

Implementing An Eu Pull Incentive For Antimicrobial Innovation And Access: Blueprint For Action, Michael Anderson, Adrian Towse, Kevin Outterson, Elias Mossialos

Faculty Scholarship

In June, 2023, the Council of the EU published a recommendation that the European Commission should contribute to the design and governance of an EU cross-country pull incentive to stimulate antimicrobial innovation and access. In this Personal View, we discuss six key considerations to support the implementation of the new pull incentive—ie, the size of the potential pull incentive and possible contributions of the member states, design of the incentive model, interplay of the new pull incentive with the proposed revisions of the EU pharmaceutical legislation, roles and responsibilities of both the EU and member states, balance between pull and …

Perspectives On The Constitution Of The War On Drugs: A Collection Of Posts From The Balkinization Blog, Douglas A. Berman, Rachel Barkow, Louis Michael Seidman, Kimani Paul-Emile, Jennifer D. Oliva, Shaun Ossei-Owusu, Katherine Shaw, Paul Butler, David E. Pozen

Faculty Scholarship

This collection of essays provides extended commentary from multiple law professors on David Pozen’s 2024 book, The Constitution of the War on Drugs. Pozen’s book provides a rich and astute perspective on a wide array of dynamic legal, political, and social stories at the intersection of constitutional jurisprudence and drug policy. The work is the first book in Oxford University Press’s Inalienable Rights series to be fully open access. Yale Law Professor Jack Balkin, recognizing the book engaged many historical and cutting-edge issues in the fields of constitutional law, criminal law and health law, invited professors in these fields …

Brief For Amici Curiae Legal Scholars Supporting Respondent, Nicole Huberfeld, Timothy S. Jost, Linda C. Mcclain, Wendy E. Parmet, Erwin Chemerinsky, Elizabeth Mccuskey, Danielle Pelfrey Duryea, Gabriel Scheffler, George J. Annas

Faculty Scholarship

QUESTION PRESENTED: Whether the Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd, preempts Idaho law in the narrow but important circumstance where terminating a pregnancy is required to stabilize an emergency medical condition that would otherwise threaten serious harm to the pregnant woman’s health but the State prohibits an emergency-room physician from providing that care.

Charging Abortion, Milan Markovic

Faculty Scholarship

As long as Roe v. Wade remained good law, prosecutors could largely avoid the question of abortion. The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization has now placed prosecutors at the forefront of the abortion wars. Some chief prosecutors in antiabortion states have pledged to not enforce antiabortion laws, whereas others are targeting even out-of-state providers. This post-Dobbs reality, wherein the ability to obtain an abortion depends not only on the politics of one’s state but also the policies of one’s local district attorney, has received minimal scrutiny from legal scholars.

Prosecutors have broad charging discretion, …

Employer-Sponsored Reproduction, Valarie K. Blake, Elizabeth Mccuskey

Faculty Scholarship

This Article interrogates the current and future role of employer-sponsored health insurance in reproductive choice, revealing the magnitude of impact that employers’ insurance coverage choices have on Americans’ access to reproductive care, as well as the legal infrastructure that prioritizes employer choice over individual autonomy.

Over half the population depends on employers for health insurance. The laws regulating those plans grant employers discretion in what services to cover, with exceptionally wide latitude for employers’ choices about reproductive care services, like abortion, contraception, infertility, and pre-exposure prophylaxis (PrEP). In their role as health care funders, employers pursue their own economic interests, …

The Wages Of Crying Roe: Some Realism About Dobbs V. Jackson Women’S Health Organization, Neil S. Siegel

Faculty Scholarship

The U.S. Supreme Court’s reasoning in Dobbs v. Jackson Women’s Health Organizationcannot be taken seriously. The Court’s stated rationale for rejecting continued protection of the abortion right—that abortion is not deeply rooted in nineteenth century history and tradition—applies with equal force to other substantive due process rights that the DobbsCourt repeatedly insisted were not under threat even without considering stare decisis, including contraception, sexual intimacy between consenting adults, and same-sex marriage. One should add inter-racial marriage and protection from involuntary sterilization to that list. Rather than applying its draconian version of the “history and tradition” test in a …

Sports Participation By Athletes With Cardiovascular Disease, Matthew W. Martinez, Michael J. Ackerman, George J. Annas, Aaron L. Baggish, Sharlene M. Day, Kimberly G. Harmon, Jonathan H. Kim, Benjamin D. Levine, Margot Putukian, Rachel Lampert

Faculty Scholarship

Millions of young people participate in competitive sports, with well-documented physical and psychological benefits.1 Athletes may be diagnosed with cardiovascular disease (CVD) during evaluation of symptoms, routine preparticipation screening, or clinically indicated family screening. When this occurs, decisions about return-to-play (RTP) are difficult, especially in circumstances when risk may exist or be unknown. Historically, expert consensus documents such as the Bethesda Conference Proceedings,2 provided a “yes/no” approach to RTP after a diagnosis of a CVD such as hypertrophic cardiomyopathy (HCM) or long QT syndrome (LQTS). These recommendations were made with a paucity of data, and were predicated on a zero-risk …

Structural Sex Discrimination: Why Gynecology Patients Suffer Avoidable Injuries And What The Law Can Do About It, Christopher Robertson, Annabel Kupke, Louise P. King

Faculty Scholarship

The nearly four million Americans who undergo gynecological surgeries each year suffer avoidable lifelong, painful, and disabling injuries. This Article diagnoses the root cause in our legal framework for healthcare finance and identifies legal solutions.

America’s public-private system for reimbursing healthcare pays for procedures rather than outcomes, and it pays substantially more for work on male rather than female anatomies. This disparity is due to the federal government’s reliance on a secretive industry committee to set those rates, and the committee’s reliance on junk science surveys, allowing self-interested and gender-biased responses, contrary to objective measures.

As payors disvalue the bodies …

Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran

Faculty Scholarship

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to …

Municipal Abortion Bans: When Local Control Clashes With State Power, Laura D. Hermer

Faculty Scholarship

Anti-abortion activists are using different strategies in different states. Some focus on restricting zoning for abortion clinics. Others address the licensure of abortion providers. Some purport to create a cause of action for private individuals to sue neighbors and others in their municipality who get an abortion. Still, others seek to enforce the federal Comstock Act, alleging that it prohibits the mailing of abortifacients and preempts state abortion law to the contrary.

This Article evaluates the likely success of each of these strategies in two states in which they are currently being tried: Nebraska and New Mexico. Part I will …

Confusion, Chaos, And Conflict In U.S. Law And Health Care After Dobbs, Nicole Huberfeld

Faculty Scholarship

The U.S. Supreme Court’s Dobbs decision caused a proliferation of contradictory state laws and judicial decisions that are producing confusion for health care providers, which in turn limits access to care for all patients of reproductive age. This paper documents the rapidly changing legal landscape to investigate and contextualize the significance of these inter‑state conflicts and illustrate how inequities deepen when health care is left in the hands of state governments without national law to provide guardrails. Drawing on interdisciplinary scholarship, including legal, medical, and public health research, this essay considers how traditional federalism theory, which encourages sub‑government variation, does …

Wipo Negotiations On Intellectual Property, Genetic Resources And Associated Traditional Knowledge, Peter K. Yu

Faculty Scholarship

At the 2000 General Assembly, the World Intellectual Property Organization (WIPO) established the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) to address intellectual property issues relating to genetic resources, traditional knowledge (TK) and traditional cultural expressions (TCEs). Although the IGC initially focused its work on studying these issues, it obtained a new mandate to accelerate its work in October 2009 and began text-based negotiations on an international instrument, or international instruments, a few months later. These negotiations paved the way for WIPO to convene a diplomatic conference to conclude an International Legal Instrument Relating …

Sharing Pathogen Sequence Data For Global Scientific Research Under The Nagoya Protocol To The Convention On Biological Diversity, Jerome H. Reichman, Carolina Dos S. Ribeiro, George B. Haringhuizen, Paul F. Uhlir

Faculty Scholarship

The Nagoya Protocol to the Convention on Biological Diversity (CBD) has threatened to impede access to genetic resources and related data for cross-border scientific research. In principle, every use of genetic resources would require a set of contracts under the CBD, in a “bilateral” regime. The related transaction costs could overwhelm many transnational research undertakings, affecting even public health responses to outbreaks and epidemics. However, the Nagoya Protocol also offers a unique opportunity to resolve this dilemma, despite struggles to define the meaning and coverage of “digital sequence information.” The coverage of genetic sequence data under the CBD remains controversial …

Rethinking Foundations And Analyzing New Conflicts: Teaching Law After Dobbs, Nicole Huberfeld, Linda C. Mcclain, Aziza Ahmed

Faculty Scholarship

This Article draws on our diverse and complementary areas of scholarly expertise and teaching experiences across law school and public health curricula to offer a multidisciplinary model for teaching in a variety of courses after Dobbs. Teaching reproductive rights and justice poses extensive challenges in the wake of Dobbs' overruling Roe v. Wade and Planned Parenthood v. Casey, upending a half century of precedents protecting a constitutional right to abortion, and returning the issue to "the people" and the states. This Article offers theoretical and pedagogical perspectives on teaching courses in Reproductive Rights and Justice, as well …

Human Rights In Hospitals: An End To Routine Shackling, Neil Singh Bedi, Nisha Mathur, Judy D. Wang, Avital Rech, Nancy Gaden, George J. Annas, Sondra S. Crosby

Faculty Scholarship

Medical students (NSB, NM, JDW) spearheaded revision of the policy and clinical practice for shackling incarcerated patients at Boston Medical Center (BMC), the largest safety net hospital in New England. In American hospitals, routine shackling of incarcerated patients with metal restraints is widespread—except for perinatal patients—regardless of consciousness, mobility, illness severity, or age. The modified policy includes individualized assessments and allows incarcerated patients to be unshackled if they meet defined criteria. The students also formed the Stop Shackling Patients Coalition (SSP Coalition) of clinicians, public health practitioners, human rights advocates, and community members determined to humanize the inpatient treatment of …