Medical-legal partnerships connect legal advocates to healthcare providers and settings. Maintaining effectiveness of medical-legal partnerships and consistently identifying opportunities for innovation and adaptation takes intentionality and effort. In this paper, we discuss ways in which our use of data and quality improvement methods have facilitated advocacy at both patient (client) and population levels as we collectively pursue better, more equitable outcomes.

In recent months, pharmaceutical manufacturers have brought legal challenges to a provision of the 2022 Inflation Reduction Act (IRA) empowering the federal government to negotiate the prices Medicare pays for certain prescription medications. One key argument made in these filings is that price negotiation is a “taking” of property and violates the Takings Clause of the US Constitution. Through original case law and health policy analysis, we show that government price negotiation and even price regulation of goods and services, including (...) patented goods, are constitutional under the Takings Clause. Finding that the IRA violates the Takings Clause would radically upend settled constitutional law and jeopardize the US’s most important state and federal health care programs. (shrink)

This response to Kariyawasam and Rai affirms their critique of the pathologization of trans youth but forecasts a foreseeable negative outcome of their proposed elimination of diagnosis as a prerequisite to gender-affirming care (GAC) — the risk of removing GAC entirely from the medical sphere and compromising the wellbeing of those transgender individuals for whom GAC is deeply affirming. We suggest an ethical framework of GAC that expands past a focus on autonomy to incorporate a principle of respect for persons (...) that affirms the dignity and diversity of trans youth — recognizing the need to facilitate both medical assistance and social change. (shrink)

In “Missing the Forest for the Trees: Aduhelm, Accelerated Approvals & the Agency,” Dr. Matthew Herder argues that agency capture and politicized discretion drive delays in confirmatory trials of accelerated approval drugs amongst other concerns at US Food and Drug Administration (FDA). In highlighting this important problem and offering nuanced insight into agency workings based in part on interviews with twenty-three unnamed FDA officials and a three-drug case study, Dr. Herder suggests two innovative solutions. However, amidst broader debates balancing agency (...) expertise, data, and delegation, these proposed policy solutions would benefit from more corroborative evidence and consideration of institutional advantages within constitutional limits. (shrink)

This article confronts the challenges and opportunities presented by medical-legal partnerships (MLPs) representing families impacted by the family regulation system. Based on the authors’ experience developing a collaboration between a medical-legal partnership, interdisciplinary law school clinic and nurse home visiting program focused on clients impacted by the family regulation system, the article challenges traditional conceptions of the MLP model and proposes an expanded vision for MLPs to address systemic injustice and improve outcomes for families.

Health systems are integrating medical-legal partnerships (MLPs) into clinical care and increasingly center “complex care” patients. These patients have intersecting medical and social needs and often face systemic inequities that exacerbate their chronic health conditions. This paper describes a role for MLPs in hospital quality initiatives; examines the ethics of MLPs assisting with guardianship and institutionalization of hospital patients including marginalized groups; and advocates for MLP interventions designed to address intersectional and ethical concerns.

Unmet legal needs contribute to housing, income, and food insecurity, along with other conditions that harm health and drive health inequity. Addressing health injustice requires new tools for the next generations of lawyers, doctors, and other healthcare professionals. An interprofessional group of co-authors argue that law and medical schools and other university partners should develop and cultivate Academic Medical-Legal Partnerships (A-MLPs), which are uniquely positioned to leverage service, education, and research resources, to advance health justice.

The US Food and Drug Administration’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer’s disease, has motivated multiple policy reforms. Drawing a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA’s core priorities and restore the regulatory system’s commitment to scientific rigor.

Palliative care and medical-legal partnership are complementary disciplines dedicated to integrating care to treat the whole patient and intervening before a legal or medical issue is at a crisis point. In this paper, we discuss the founding and operations of the Yale Palliative Medical Legal Partnership, give examples of typical cases, explain special considerations in this area of law, and propose areas for further research.

As reproductive freedoms in the U.S. undergo significant rollbacks, vital reproductive health services — and the care teams delivering them — face escalating legal threats and complexity. This qualitative case-control community-based participatory research study describes how legal problem-solving supports for reproductive care teams serving mothers with opioid use disorder are protective for both patients and care team members. We describe how medical legal partnerships (MLPs) can promote Reproductive Justice and argue for wider adoption of care-team facing legal supports.

Political debate regarding trans youth’s access to gender-affirming care (GAC) has pushed many to advocate for GAC by pointing to tragic, pathological outcomes of non-treatment, namely suicide. However, these pathologized arguments are a harmful ethical “shortcut” which should be replaced by a meaningful engagement with the ethics of providing GAC to youth.

The COVID-19 pandemic laid bare systemic inequities shaped by social determinants of health (SDoH). Public health agencies, legislators, health systems, and community organizations took notice, and there is currently unprecedented interest in identifying and implementing programs to address SDoH. This special issue focuses on the role of medical-legal partnerships (MLPs) in addressing SDoH and racial and social inequities, as well as the need to support these efforts with evidence-based research, data, and meaningful partnerships and funding.

The complex regulatory framework governing the U.S. health care system can be an obstacle to programming that address health-related social needs. In particular, health care fraud and abuse law is a pernicious barrier as health care organizations may minimize or forego programming altogether out of real and perceived concern for compliance. And because health care organizations have varying resources to navigate and resolve compliance concerns, as well as different levels of risk tolerance, fears related to the legal landscape may further (...) entrench inequities in access to meaningful programs that improve health outcomes. This article uses food and nutrition programming as a case study to explore the complexities presented by this area of law and to highlight pathways forward. (shrink)

Many formerly incarcerated people have civil legal needs that can imperil their successful re-entry to society and, consequently, their health. We categorize these needs and assess their association with cardiovascular disease risk factors in a sample of recently released people. We find that having legal needs related to debt, public benefits, housing, or healthcare access is associated with psychosocial stress, but not uncontrolled high blood pressure or high cholesterol, in the first three months after release.

Across the country, legal and health care professionals who understand that health outcomes are most influenced by social and environmental conditions have improved patient health by adopting the interdisciplinary MLP health care delivery model. However, the MLP field cannot advance population health, let alone long-term health equity, until it addresses the structural determinants of health inequity that are rooted in discrimination, segregation, and other forms of racial and ethnic subordination.

State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team’s larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious (...) wrongdoing by physicians. (shrink)

The social ecological model (SEM) is a conceptual framework that recognizes individuals function within multiple interactive systems and contextual environments that influence their health. Medical Legal Partnerships (MLPs) address the social determinants of health through partnerships between health providers and civil legal services. This paper explores how the conceptual framework of SEM can be applied to the MLP model, which also uses a multidimensional approach to address an individual’s social determinants of health.

The United Nations (UN) General Assembly High-Level Meeting (HLM) on pandemic prevention, preparedness and response (PPPR) was a missed opportunity to bring high-level commitment and momentum to the global governance of health emergencies. Intended to bring much-needed attention to a policy issue that is rapidly slipping down the international agenda, the fraught diplomacy among member states, lack of consensus on key issues, and weak UN Political Declaration in New York foreshadow a difficult road ahead for upcoming negotiations under the World (...) Health Organization (WHO) in Geneva. This column chronicles the evolving engagement of the UN in global health governance, examines the diplomatic process leading to the UN HLM on PPPR, and assesses the contributions and missed opportunities of its resulting Political Declaration. (shrink)

The upstream framework presented in public health and medicine considers health problems from a preventive perspective, seeking to understand and address the root causes of poor health. Medical-legal partnerships (MLPs) have demonstrated the value of this upstream framework in the practice of law and engage in upstream lawyering by utilizing systemic advocacy to address root causes of injustices and health inequities. This article explores upstreaming and its use by MLPs in reframing legal practice.

To provide effective care physicians must attend, not just to medical issues, but also to the social determinants of health — racial factors, food insecurity, housing instability, transportation barriers and beyond. Social determinants also include a largely underrecognized dimension: legal vulnerabilities such as rental evictions and debt adjudications. Yet rarely do medical trainees have an opportunity to witness legal vulnerabilities, firsthand.

Developers and vendors of large language models (“LLMs”) — such as ChatGPT, Google Bard, and Microsoft’s Bing at the forefront—can be subject to Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) when they process protected health information (“PHI”) on behalf of the HIPAA covered entities. In doing so, they become business associates or subcontractors of a business associate under HIPAA.

While Medical-Legal Partnerships (MLPs) have improved the health and well-being of the people they serve, most healthcare institutions will only invest in an MLP if they are convinced that doing so will improve its balance sheet. This article offers a detailed estimation of the cost savings that an MLP targeted toward the most acute legal needs would accrue to an academic medical center (AMC) in North Carolina.

Medical-legal partnership (MLP) embeds attorneys and paralegals into care delivery to help clinicians address root causes of health inequities. Notwithstanding decades of favorable outcomes, MLP is not as well-known as might be expected. In this essay, the authors explore ways in which strategic alignment of legal services with healthcare services in terms of professionalism, information collection and sharing, and financing might help the MLP movement become a more widespread, sustainable model for holistic care delivery.

Our students ought to know about the history of formal hospital segregation and desegregation. To that end, this article urges those who teach foundational health law and policy courses to do three things. First, to teach the Simkins case. Second, to swap out the usual Medicare signing ceremony picture for one that includes W. Montague Cobb, M.D., Ph.D. Third, to highlight how the implementation of that program for the elderly led, in a matter of months, to the desegregation of hospitals (...) throughout the country. (shrink)

Medical-legal partnerships (MLPs) have the potential to address racial health disparities by improving the conditions that constitute the social determinants of health. In order to live up to this potential, these partnerships must intentionally incorporate seven core racial justice principles into their design and implementation. Otherwise, they are likely to replicate the systemic barriers that lead to racialized health disparities.

The federal government is funding a sea change in health care by investing in interventions targeting social determinants of health, which are significant contributors to illness and health inequity. This funding power has encouraged states, professional and accreditation organizations, health care entities, and providers to focus heavily on social determinants. We examine how this shift in focus affects clinical practice in the fields of oncology and emergency medicine, and highlight potential areas of reform.

Through qualitative surveys, a team of law students, law professors, physicians, and residents explored the perceptions of neurology residents towards referral to appropriate legal resources in an academic training program. Respondents reported feeling uncomfortable screening their patients for health-harming legal needs, which many attributed to a lack of training in this area. These findings indicate that neurology residents would benefit from training on screening for social factors that may be impacting their patients’ health.

In 2022, the Camden Coalition Medical-Legal Partnership began providing civil and criminal legal services to substance use disorder patients at Cooper University Health Care’s Center for Healing. This paper discusses early findings from the program’s first year on the efficacy of the provision of criminal-legal representation, which is uncommon among MLPs and critical for this patient population. The paper concludes with takeaways for other programs providing legal services in an addiction medicine setting.

This article describes a new type of medical-legal partnership (MLP) that targets the health and justice concerns of people enmeshed in the U.S criminal justice system: a partnership between clinicians who care for people with criminal system involvement and public defenders. This partnership offers an opportunity to not only improve patient health outcomes but also to facilitate less punitive court dispositions, such as jointly advocating for community-based rehabilitation and treatment rather than incarceration.

Medical-Legal Partnerships (MLPs) have been widely acclaimed for promoting health equity and achieving meaningful outcomes. Yet, little to no research has analyzed if this critical work has been done with communities — through meaningful engagement and building power — or if it has been done for communities without their involvement.

A series of structural constitutional arguments lodged in multiple cases against Centers for Medicare and Medicaid Services’ (CMS) authorities to negotiate prescription drug prices via the 2022 Inflation Reduction Act threaten the legitimacy of CMS program and federal agency powers.

Dobbs v. Jackson Women’s Health continues a trajectory of U.S. Supreme Court jurisprudence that undermines the normative foundation of public health — the idea that the state is obligated to provide a robust set of supports for healthcare services and the underlying social determinants of health. Dobbs furthers a longstanding ideology of individual responsibility in public health, neglecting collective responsibility for better health outcomes. Such an ideology on individual responsibility not only enables a shrinking of public health infrastructure for reproductive (...) health, it facilitates the rise of reproductive coercion and a criminal legal response to pregnancy and abortion. This commentary situates Dobbs in the context of a long historical shift in public health that increasingly places burdens on individuals for their own reproductive health care, moving away from the possibility of a robust state public health infrastructure. (shrink)

When we conceptualized this symposium, Roe v. Wade1 was still the law of the land, albeit precariously. We aimed to commemorate its fiftieth anniversary by exploring historical, legal, medical, and related dimensions of access to abortion as well as the challenges ahead to secure reproductive justice. With the leak of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization on May 2, 2022, we shifted to mark the dawn of a new era. In the nearly identical official (...) opinion announced on June 24, 2022,2 Justice Samuel Alito, writing for the majority (6-3), overturned Roe and Planned Parenthood of Southeastern Pennsylvania v. Casey.3. (shrink)

Abortion stories have always played a powerful role in advancing women’s rights. In the abortion sphere particularly, the personal is political. Following the Court’s reversal of Roe v. Wade, abortion politics, and abortion storytelling, take on an even deeper political role in challenging the bloodless judicial language of Dobbs with the lived experience of women.

The global impact of Dobbs v. Jackson Women’s Health Organization and the backlash towards reproductive justice that it represents warrant a global feminist response informed by broad theoretical and geopolitical lenses. We consider how a solidaristic, transnational feminist movement might learn from Latin American feminist movements that have been successful in uniting broad coalitions in the fight for reproductive justice as situated within far-reaching political goals. The success of such a global movement must be decolonial and must contend with the (...) fact that overlapping realities of global inequality, severe poverty, extractivism, and western-backed violence are fundamentally implicated in reproductive justice. (shrink)

Low-income women and, disproportionately low-income women of color seeking reproductive and pregnancy care are increasingly subject to what this article terms carceral care – care compromised by its’ proximity to punishment systems. This article identifies the legal and health care practice mechanisms leading to carceral care and proposes solutions designed to stop criminalization at the bedside.

The overturn of Roe v. Wade has resulted in fewer rights and resources for people seeking abortion care, particularly in the South. The Hyde Amendment has historically restricted abortion access for those enrolled in Medicaid. We argue here that its guarantees of minimum abortion coverage should be leveraged to offset harms where possible.

Punitive policy responses to substance use and to abortion care constitute direct attacks on personal liberty and bodily autonomy. In this article, we leverage the concept of “syndemics” to anticipate how the already synergistic stigmas against people who use drugs and people who seek abortion services will be further compounded the Dobbs decision.

This column will be the first in a series exploring innovative ways to teach concepts and ideas in health law across a wide variety of classrooms, schools, and curriculums.

In anticipation of extraterritorial application of antiabortion laws, many states have enacted laws that attempt to shield abortion providers, helpers, and patients from civil, professional, or criminal liability associated with legal abortion care. This essay analyzes and compares the statutory schemes of the seven early adopting shield states: California, Connecticut, Delaware, Illinois, Massachusetts, New Jersey, and New York. After describing what the laws do and how they operate, we offer reflections on coming disputes, areas of legal uncertainty, and ways to (...) improve future shield laws. (shrink)

On June 18, 2023, the U.S. Supreme Court in the matter of Amgen, Inc. et al. v. Sanofi, et al.1 unanimously upheld the 2021 decision of the U.S. Court of Appeals for the Federal Circuit,2 striking down as overbroad Amgen’s patent claim to an entire functional genus of monoclonal antibodies. Amgen’s patent claims were not limited to antibody structure or antibody amino acid sequences. This is significant because Amgen’s patent claims did have amino acid sequences, but they were directed to (...) the epitope. (shrink)

This article explores the impact of Dobbs on access to assisted reproductive technologies. Clinical aspects of IVF, including embryo discard and cryopreservation, preimplantation genetic testing, and selective reduction of multiple pregnancy are potentially jeopardized by a new legal landscape that protects embryos over the interest of infertility patients.

Medical aid in dying (MAiD), despite being legal in many jurisdictions, remains controversial ethically. Existing surveys of physicians’ perceptions of MAiD tend to focus on the legal or moral permissibility of MAiD in general. Using a novel sampling strategy, we surveyed physicians likely to have engaged in MAiD-related activities in Colorado to assess their attitudes toward contemporary ethical issues in MAiD.

In our article, we share the lessons we have learned after creating and running a successful legal laboratory over the past seven years at Yale Law School. Our legal laboratory, which focuses on the intersection of law and severe brain injury, represents a unique pedagogical model for legal academia, and is closely influenced by the biomedical laboratory.

Current guidelines and regulatory frameworks create a dilemma that threatens the effectiveness of much needed communication between patients and medical providers: How can patients be presented with detailed facts without creating cognitive “overload”? We explain how this is a false dichotomy and illustrate, using three examples, how fuzzy-trace theory offers a third way of informing patients.

This article argues that state laws banning abortions for disability violate reproductive justice for parents with disabilities. These bans deprive people with disabilities of choices that may be important to their possibilities of becoming parents, including possibilities for abortion of pregnancies that have become risky to continue. Far from protecting disability civil rights, these state law bans restrict the abilities of people with disabilities to choose to have children and to parent.

The emerging global climate crisis threatens human health in unprecedented ways, yet global health concerns have not been sufficiently considered within international climate change efforts. A more collaborative pathway could advance efforts to mitigate and adapt to climate change while protecting public health and social justice.

In another tumultuous term of the United States Supreme Court in 2022-2023 a series of critical cases implicate instant and forthcoming changes in multiple fronts that collectively shift the national public health law and policy environment.

The incidence of elder abuse has led to a growing trend of states taking various methods to regulate the use of electronic monitoring in institutional settings through programs, guidelines, regulations, and laws. This article attempts evaluate how the regulation of electronic monitoring has evolved and may be advanced in the future with the anticipated increase of elder abuse.

This article considers challenges facing the pro-life movement after Dobbs v. Jackson Women’s Health Organization (2022). It identifies four questions the movement must face: (1) whether to adopt a combative or conciliatory rhetorical stance; (2) how to prioritize new legislative goals; (3) how to define the limits of acceptable compromise; and (4) how to respond to Americans with ambivalent attitudes toward abortion. The article argues that each of these issues could precipitate serious division in the pro-life movement that will impact (...) likelihood of future success. (shrink)

Decision making during reproduction is complex for a variety of medical and social reasons. Anyone who has had a conversation with a family member about the “best time” to have a baby can attest to this — there is no “best time” or “best way.” Multiple pressures from any number of sources combine in a minefield of hazards made ever more complicated by restrictive laws in the US. Add to this a screening result of potential chromosomal aneuploidy and decision making (...) becomes ever more complex. Societal stigma and lack of adequate and accurate information during counseling certainly plays a role in the high number of terminations in the setting of diagnosed chromosomal aneuploidy, yet other factors also push families in this direction including medical considerations and the abysmal lack of social support programs. (shrink)

The end of Roe v. Wade has significant implications for the autonomy of pregnant patients at the end of life. At least thirty states restrict the choice to withhold/withdraw life-sustaining treatments from pregnant patients without decisional capacity, invalidating prior advance directives and prohibiting others from choosing these options for the patient. Many restrictions are based on the Roe framework, applying after “viability” or similar considerations of fetal development or prospect for live birth. Scholars have also relied on the abortion framework, (...) arguing that the restrictions impose an undue burden. The end of Roe will free states from having to craft limited restrictions designed to work around prior abortion jurisprudence. Similarly, advocates will no longer be able to draw support from the abortion framework, forcing them to rely instead on cases supporting rights to autonomy/bodily integrity in medical decision-making. (shrink)

The COVID-19 pandemic has been devastating for people living with dementia (PLWD) and their caregivers. While prior research has documented these effects, it has not delved into their specific causes or how they are modified by contextual variation in caregiving circumstances.

Harvey and Gurvir’s Law is a bill proposed to the Legislative Assembly of Ontario (Canada) to reduce stigma and bias associated with Down syndrome, by developing and disseminating quality information about Down syndrome in the context of prenatal testing.

The Supreme Court decided Box v. Planned Parenthood of Indiana and Kentucky in 2019. Justice Clarence Thomas’s opinion in the case claimed there was a direct connection between the legalization of abortion, in the late 20th Century, and the beginnings of the birth control movement a full three quarters of a century earlier. “Many eugenicists,” Thomas argued, “supported legalizing abortion.”Justice Samuel Alito highlighted similar claims in Dobbs v. Jackson Women’s Health, citing a brief entitled “The Eugenic Era Lives on through (...) the Abortion Movement.” That brief was an echo of Justice Thomas’ misguided attempt at history in the Box opinion. Similar claims reoccur in Judge Matthew Kacsmaryk’s opinion in the Texas mifepristone case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.These false claims are the focus of this article. There is no evidence that early leaders of the eugenics movement supported abortion as part of the movement for birth control. It is accurate to describe those leaders as anti-abortion, and their followers as people who condemned abortion for moral, legal, and medical reasons. (shrink)

While empirical evidence has exposed the harms and health disparities flowing from being denied a wanted abortion, we know less about how anti-abortion laws and policies impact health care more broadly. This article surveys the public health impacts of Dobbs on health care beyond wanted abortion care. The article argues that focusing the public’s attention on the harmful consequences of abortion bans for healthcare beyond wanted abortion care could help to fend off further restrictions on abortion.

This paper reports our analysis of the ELSI Virtual Forum: 30 Years of the Genome: Integrating and Applying ELSI Research, an online meeting of scholars focused on the ethical, legal, and social implications (ELSI) of genetics and genomics.

This article explores the role of the Food and Drug Administration (FDA) in drug approval and restrictions to mifepristone access in the context of historical regulation and current litigation.

The Dobbs decision will directly affect patients and reproductive rights; it will also impact patients indirectly in many ways, one of which will be changes in the physician workforce through its impact on graduate medical education. Current residency accreditation standards require training in all forms of contraception in addition to training in the provision of abortion. State bans on abortions may diminish access to training as approximately half of obstetrics and gynecology residency programs are in states with significant abortion restrictions. (...) The Dobbs decision creates numerous hurdles for trainees and their programs. Trainees in restrictive states will have to travel to learn in a different program in a protective state. As training opportunities diminish, potentially leading to a decline in clinical skills, knowledge, and experience in the provision of abortion, the rate of complications and maternal mortality are likely to rise. This will likely have a disproportionately negative effect on preexisting disparities in reproductive health fueled by a longstanding history of systemic racism and inequities. This work aims to both define the looming problem in abortion training created by Dobbs and propose solutions to ensure that an adequate workforce is available in the future to serve patient needs. (shrink)

Dobbs appears more extreme when juxtaposed against Roe’s hidden history. Justice Blackmun was the author of Roe, but the opinion was the product of a remarkable collaboration that incorporated the suggestions of many Justices. Thus, Roe’s medical framing embodied the vision of the Court as a whole, not one individual.

This article argues that the Supreme Court’s decision in Dobbs is likely to impact medical decision-making by pregnant patients in a variety of contexts. Of particular concern are situations where a patient declines treatment recommended for its potential benefit to the fetus and situations where treatment is withheld due to potential risk to the fetus. The Court’s elevation of fetal interests, combined with a history of courts using abortion jurisprudence to guide their reasoning in compelled treatment cases, means that Dobbs (...) has the potential to limit patient autonomy in a wide array of clinical settings. The article calls on professional medical associations to issue ethical guidance affirming the duty to respect the medical self-determination of pregnant patients. (shrink)

The end of the constitutional right to abortion with Dobbs v. Jackson Women’s Health stands to generate massive conflict between abortion regulation and the First Amendment. Abortion exceptionalism within constitutional doctrine -- which both treats abortion differently than other areas and favors anti-abortion over pro-choice viewpoints -- will not retreat but advance, unless confronted by the courts.

Elected prosecutors have pledged not to enforce abortion laws, in response to state-level abortion bans. For their pledges to be meaningful, prosecutors must exercise their discretion in cases of individuals who face legal risk, including people who help others self-manage their abortions. With a harm-reduction approach to improving abortion access, prosecutors should aim to reduce abortion helpers’ involvement with the criminal justice system.

While sexual violence should not be the prerequisite for legal abortion, expanding definitions of abuse to include reproductive coercion can open avenues of access to abortion following the Dobbs decision. Understanding the increased danger and compounding challenges of intimate partner violence can inform legislative initiatives, healthcare responses, and movements for reproductive justice.

Post-Dobbs abortion restrictions impact access and choice in the context of reproductive genetic medicine, raising serious reproductive justice concerns. The consequences of these restrictions are particularly acute and far-reaching for individuals with genetic conditions and their families.

This essay examines the right of health care freedom of choice contained in some state constitutions. It explores how courts have, and could, use this constitutional health care right as a basis for recognizing or reinforcing a fundamental right to choose an abortion.

This article explores how abortion bans in states with large Black populations will exacerbate existing racial inequities in those states’ child welfare systems.

The Dobbs opinion emphasizes that the state’s interest in the fetus extends to “all stages of development.” This essay briefly explores whether state legislators, agencies, and courts could use the “all stages of development” language to expand reproductive surveillance by using novel developments in consumer health technologies to augment those efforts.

In light of a history of categorical exclusion, it is critical that pregnant people are included in research to help improve the knowledge base and interventions needed to address public health. Yet the volatile legal landscape around reproductive rights in the United States threatens to undue recent progress made toward the greater inclusion of pregnant people in research. We offer ethical and practical guidance for researchers, sponsors, and institutional review boards to take specific steps to minimize legal risks and ensure (...) the ethical conduct of research with pregnant people in an evolving legal environment. (shrink)

Mild and moderate mental illnesses can hinder labor force participation, lead to work interruptions, and hamper earning potential. Targeted interventions have proven effective at addressing these problems. But their potential depends on labor protections that enable people to take advantage of these interventions while keeping jobs and income.

Studies of public health decisions that have had harmful effects tend to disagree about what constitutes a public health error. Debates exist about whether public health errors must be culpable or not, as well as about what the criteria for judging public health errors should be.

Legal challenges to the FDA’s approval of mifepristone have destabilized patients’ ability to access controversial medicines like medication abortion. We argue that federal courts’ receptiveness to this litigation undermines the coherence and integrity of prescription drug regulation in the U.S.

The United States has the fastest growing prison population in the world, and elevated incarceration rates, substance use, and human immunodeficiency virus (HIV) prevalence are fueling each other. Yet without a national guideline mandated for HIV care within the prison system, standards for state and federal prisons vary greatly.

This article highlights and evaluates the role of CEPI and its contribution to global equitable access to COVID-19 vaccines through its established partnerships for vaccine development. The article adds to the understanding of how and when such partnerships can work for public health, especially under emergency citations.

From its inception, the COVID-19 pandemic has been a disruptive force on U.S. health care and public health systems. President Biden’s announced termination of the national public health emergency on May 11, 2023 portends a return to normalcy and relief for Americans from the greatest infectious disease scourge the nation has ever faced. In reality, closing out this pandemic presents a tempest of legal and practical complications.

NoteThe following was written as a commentary on an article we published in our Spring 2023 issue, “’Comprehensive Healthcare for America’: Using the Insights of Behavioral Economics to Transform the U. S. Healthcare System,” by Paul C. Sorum, Christopher Stein, and Dale L. Moore. This commentary should have appeared alongside that article. We apologize to the authors and our readers for the error.

Climate change exacts a devastating toll on health that is rarely incorporated into the economic calculus of climate action. By aligning health and environmental policy and collaborating across borders, governments and industries can develop powerful initiatives to promote both environmental and human health.

This article provides a critical review of new policies in China, the United States, and the European Union that characterize genomic data as a national strategic resource. Specifically, we review policies that regulate human genomic data for economic, national security, or other strategic purposes rather than ethical or individual rights purposes.

Clinical trial recruitment is ripe for innovation. The current model is costly, often results in poor recruitment and offers inequitable access. To improve this system, we envision a peer-to-peer blockchain platform where patients control the depth and breadth of how their medical information is shared.

Global health law for pandemics currently lacks legal obligations to ensure distributional and reparative justice. In contrast, international environmental law contains several novel international legal mechanisms aimed at addressing the effects of colonialism and global injustices that arise from the disproportionate contributions to — and impacts of — climate change and biodiversity loss.

In this paper we report findings from a commissioned report to the COVID-19 Clinical Research Coalition on approaches to streamline multinational REC review/approval during public health emergencies. As currently envisioned in the literature, a system of REC mutual recognition is theoretically possible based on shared procedural REC standards, but raises numerous concerns about perceived inequities and mistrust.

Opioid agonist treatment, including methadone, is the safest and most effective method for treating opioid use disorders and reduces opioid overdose deaths. While access to methadone is highly regulated by federal law, a substantial portion of states impose stricter barriers.

This article proposes the adoption of a multi-modal system for allocating vaccine doses during large transnational outbreaks of infectious diseases. The chosen allocative criteria (public health need; country-income level; qualification through funding; and, subsidiarily, a modified lottery system) are adapted from a current embodiment of allocative multi-modality outside the context of public health: the New York City Marathon.

Indigenous health is becoming a top priority globally. The aim is to ensure equal health opportunities, with a focus on Indigenous populations who have faced historical disparities. Effective health interventions in Indigenous communities must incorporate Indigenous knowledge, beliefs, and worldviews to be culturally appropriate.

The recently revised Common Rule requires that donors of biospecimens for research be informed if their specimens might be used for commercial profit. The Common Rule, however, does not apply to sharing or selling de-identified biospecimens that are “leftover” from clinical uses. As a result, many medical researchers remain uncertain of their legal and ethical obligations when a commercial entity expresses interest in these specimens.

When confronted with moral dilemmas related to health, governments frequently turn to “moral experts,” such as bioethicists and moral philosophers, for guidance and advice. They commonly assume that these experts’ moral judgments are primarily a product of deliberate reasoning. The article challenges this assumption, arguing that experts’ moral judgments may instead be primarily a product of moral intuitions which, often subconsciously, respond to the social setting.

This article examines the legal and ethical challenges for the provision of healthcare in the metaverse. It proposes that the issues arising in the metaverse are an extension of those found in telehealth and virtual health communities, albeit with greater complexity. It argues that international collaboration between policymakers, lawmakers, and researchers is required to regulate this space and facilitate the safe and effective development of meta-medicine.

This article traces the development and growth of health justice partnerships (HJPs) in three countries: the United States, Australia and the United Kingdom.

In the US, research payments are technically taxable income. This article argues that tax liability is a form of possible economic and legal risk of paid research participation. Findings are presented from empirical research on Phase I healthy volunteer trials. The article concludes by discussing the implications of these findings for the informed consent process, as well as for broader ethical issues in whether and how payments for research participation should be regulated.

The prison-industrial complex has historically operated as a mechanism for social control generally and as a tool to restrict women’s reproductive capacities specifically. Reproductive justice is a domain within the practice of health law. However, health law as currently practiced is ill-equipped to understand how the carceral state functions as a structural determinant of health or how legacies of oppression have facilitated the abridgment of incarcerated women’s reproductive capacities.

Colorado has consistently had one of the highest rates of suicide in the United States, and El Paso County has the highest number of suicide and firearm-related suicide deaths within the state. Community-based solutions like those of the Suicide Prevention Collaborative of El Paso County may be more effective in preventing suicide as they are specific to local issues, sensitive to local culture, and informed by local data, community members, and stakeholders.

This manuscript uses competitive college football as a lens into the complexities of decision-making amid the Covid-19 pandemic. Pulling together what is known about the decision-makers, the decision-making processes, the social and political context, the risks and benefits, and the underlying obligations of institutions to these athletes, we conduct an ethical analysis of the decisions surrounding the 2020 fall football season. Based on this ethical analysis, we provide key recommendations to improve similar decision processes moving forward.

The World Health Assembly has encouraged WHO member-states to establish capacity in health technology assessment (HTA) as a support for achieving universal health coverage (UHC). Simultaneously, the WHO has stated that UHC is “a practical expression of the concern for health equity and the right to health.” This has prompted questions about potential tensions between priority-setting efforts and the right to health on the road to UHC. South Africa (SA) is an ideal setting in which to explore how the priority-setting (...) work of an HTA body may be integrated with an existing rights framework. (shrink)

Equity is a foundational concept for the new World Health Organization (WHO) Pandemic Treaty. WHO Member States are currently negotiating to turn this undefined concept into tangible outcomes by borrowing a policy mechanism from international environmental law: “access and benefit-sharing” (ABS).

Among the morass of critical issues impacting the results of the midterm elections in 2022 were core public health issues related to health care access, justice, and reforms. Collectively, voters’ communal health and safety concerns dominated outcomes in key races which may shape national, state, and local legal approaches to protecting the public’s health in the modern era.

The Supreme Court’s decision in New York State Rifle & Pistol Association Inc. v. Bruen undermines the ability of cities and states to regulate firearms safety. Nonetheless, we remain hopeful that firearm violence can decline even after the Bruen decision. Several promising public health approaches have gained broader adoption in recent years. This essay examines the key drivers of community firearm violence and reviews promising strategies to reverse those conditions, including community violence intervention (CVI) programs and place-based and structural interventions.

This article examines Bey v. City of New York — a recent Second Circuit case where four Black firefights suffering from Pseudofolliculitis Barbae (a skin condition causing irritation when shaving which mostly affects Black men) challenged the New York City Fire Department’s Clean Shave Policy — with an intersectional approach utilizing legal theories of racial, disability, and religious discrimination.

This paper evaluates the existing research on Stand Your Ground (SYG) laws in terms of the extent to which it has accounted for gender. In particular, we address (a) what the available evidence suggests are the gender-based impacts of SYG laws and (b) where, how, and why considerations of gender may be missing in available studies.

During the 20th Century, thirty-two state legislatures passed laws that sanctioned coercive sexual sterilization as a solution to the purported detrimental increases in the population of “unfit” or “defective” citizens. While both scholarly and popular commentary has attempted to attribute these laws to political parties, or to broad or poorly defined ideological groups such as “progressives,” no one has identified the political allegiance of each legislator who introduced a successfully adopted sterilization law, and the governor who signed it. This article (...) remedies that omission. (shrink)

Vermeulen et al. suggest a moral duty exists for physicians to inform patients of “relevant opportunities” for Expanded Access. Such a duty is likely both too broad, leading to important practical challenges, and too narrow, without further steps to promote patient access. However, physicians should be expected to be aware of the EA pathway, disclose it to eligible patients, and support the pursuit of EA options reasonably likely to help.

In June 2021, Missouri passed the “Second Amendment Preservation Act” (SAPA). Though SAPA passed easily and had gubernatorial support, many Missouri law enforcement agencies, including the Missouri Sheriff’s Association, oppose it. Missing from this policy conversation, and deserving of analysis, is the voice of Missouri citizens. Using qualitative interview data and survey data, we explored what if anything Missouri gun owners knew about SAPA and what they perceived its effects would be on gun-related murders, suicides, gun thefts, and mass shootings. (...) Most Missouri gun owners had not heard about SAPA and were ambivalent about its potential effect on gun safety outcomes. Our findings also indicate that respondents’ attitudes toward SAPA and the impact of such policy on safety is driven by gun ownership (i.e., primary versus living in a household with firearms), partisan identification, and attitudes toward government firearm regulation. (shrink)

Abstract“Comprehensive Healthcare for America” is a largely single-payer reform proposal that, by applying the insights of behavioral economics, may be able to rally patients and clinicians sufficiently to overcome the opposition of politicians and vested interests to providing all Americans with less complicated and less costly access to needed healthcare.

More than half of all intimate partner homicides involve a firearm and firearms are frequently used by perpetrators of intimate partner violence (IPV) to injure and threaten victims and survivors. Recent court decisions undermine important legal restrictions on firearm possession by IPV perpetrators, thus jeopardizing the safety of victims and survivors. This article reviews the history and recent developments in the law at the intersection of IPV and firearm violence and proposes a way forward through a health justice framework.

The United States is distinct among high-income countries for its problem with gun violence, with Americans 25 times more likely to be killed by gun homicide than people in other high-income countries.1 Suicides make up a majority of annual gun deaths — though that gap is closing as homicides are on the rise — and the U.S. accounts for 35% of global firearm suicides despite making up only 4% of the world’s population.2 More concerning, gun deaths are only getting worse. (...) In 2021, firearm fatalities approached 50,000, the highest we have seen in at least 40 years.3 The increase in homicides in conjunction with lower crime overall further suggests an problem specifically with guns.4 As devastating as these deaths are, it does not come close to encompassing the mass toll of America’s gun violence epidemic — a toll that disproportionately impacts people of color, with the Black community suffering at the highest rates. A broader and more accurate view of what constitutes gun violence must become a part of the national discourse if we are going to develop effective strategies to combat this crisis.5. (shrink)

The European Commission’s proposal to address antimicrobial resistance using transferable exclusivity vouchers (TEVs) is fundamentally flawed. European policymakers and regulators should consider alternatives, such as better funding for basic and clinical research, use of advance market commitments funded by a pay-or-play tax, or enacting an EU Fund for Antibiotic Development.

Drawing on ethical and legal frameworks in the Netherlands, the United States and France, we examine whether physicians are expected to inform patients about potentially relevant opportunities for expanded access to investigational drugs. While we found no definitive legal obligation, we argue that physicians have a moral obligation to discuss opportunities for expanded access with patients who have run out of treatment options to prevent inequality, to promote autonomy, and to achieve beneficence.

In COVID’s immediate wake, the 2020 death toll from a different enemy of the public’s health — gun violence — ticked up by 15 percent in the United States from the previous year. Meanwhile, the U.S. Supreme Court issued an opinion in Caniglia v. Strom that will allow people who have recently threatened suicide — with a gun — to keep unsecured guns in their home unless police take time to obtain a search warrant to remove them.

Motivated by disparities in gun violence, sharp increases in gun ownership, and a changing gun policy landscape, we conducted a nationally representative survey of U.S. adults (n=2,778) in 2021 to compare safety-related views of white, Black, and Hispanic gun owners and non-owners. Black gun owners were most aware of homicide disparities and least expecting of personal safety improvements from gun ownership or more permissive gun carrying. Non-owner views differed. Health equity and policy opportunities are discussed.

We conducted a scoping review to map and critically examine the knowledge, perceptions and utilization of generics and biosimilars, among physicians, pharmacists, patients, the general population, and other stakeholders from LAC.

Asia’s pharmaceutical sector has experienced remarkable growth over the last two decades, with companies in the region producing bulk of the world’s specialty generics, biologicals, and active pharmaceutical ingredients (APIs). The Asian pharma growth story has had several pillars for a strong and sustainable foundation that provided non-linear growth. This report introduces three models showing how Asian countries at different development stages — India, South Korea, and Singapore — have nurtured their own, self-sustaining pharmaceutical sectors.

There is evidence of persistent inequalities in household financial protection of health and drugs spending in Latin America. Despite the expansion of coverage, strong inequalities persist in access to health and family spending on drugs in the region. Out-of-pocket spending in medicines is regressive in greater need for affordable medicines.

A lack of transparency and concerns over patients costs at the pharmacy counter have increased Congressional focus on pharmacy benefits management practices. However, applying regulations without transparency into pharmacy benefits managers practices could do more harm than good.

Government encouragement of free markets is a highly effective means of fostering pharmaceutical innovation; the NIH, by including “free-market provisions” in its licensing agreements that discourage anti-competitive and research-impeding behavior, can do a great deal to support this goal even without legislative overhaul.

In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow.

The US government supports drug innovation. It is therefore crucial that it distinguish between high-value and low-value innovation in purchasing expensive prescription drugs and medical devices and ensure the continued discovery of transformative drugs and that patient and taxpayer funds are not wasted.

This special JLME symposium addresses ways that federal policy can incentivize innovation in medical therapeutics and make pharmaceuticals more financially accessible.

This paper will review the strategies and learning trajectories followed to tap the opportunities opened by the successive waves of biotechnologies: early imitators followed by late imitators in the first generation of biosimilars (erythropoietin, insulins, interferons), and then sequential entry and skipping stages during the second generation (monoclonal antibodies).

This paper reviews the main pricing policies in Latin American countries, discussing their shortcomings. It also gives an overview of the most common pricing and reimbursement policies in Europe and describes in detail three well-established approaches — international price referencing, value-based pricing, including setting up of health technology assessment, and generic and biosimilar policies — building on country examples.

This article discusses the misalignment of the drug innovation model in the US with broader societal goals. The paper calls for a reconfiguration of this model to prioritize the common good and ensure equitable access to health innovations. The article stresses the importance of adopting a mission-oriented approach to shape the drug market, including reforming intellectual property rights.

This commentary highlights the scientific history of the NIH-Moderna COVID-19 vaccine and corroborates Sarpatwari’s theme of private capture of value created by the public. The commentary also identifies missteps by the Trump and Biden Administrations and offers policy recommendations: better contracts with and incentives for pharmaceutical manufacturers and a not-for-profit “public option” for pharmaceutical development.

The global market for biologics and biosimilar pharmaceutical products is experiencing rapid expansion, primarily driven by the continuous discovery of new molecules. However, information regarding Latin America’s biological market remains limited.

This paper aims to characterize the main actors in the Brazilian pharmaceutical industry — national companies, foreign companies and public laboratories — and analyze how they were affected and how they reacted to changes over the last 30 years in the institutional framework. The results show that national companies have been gaining prominence in the Brazilian pharmaceutical market with their internationalization movement and their strengthening of innovation strategies.

The demographic and epidemiological transitions are driving pharmaceutical expenditures up in Latin American and the Caribbean, with much of the cost falling on households. The domestic development and manufacturing of bio-similars could make medicines more affordable.

The NIH-Moderna mRNA COVID-19 vaccine’s steep price increase raises concerns that this will be the new anchor for continued price hikes and underscores the need for upstream government intervention to enable greater accountability and stewardship of public biomedical research investment.

Pharmacy Benefit Managers (PBM) induce drug manufacturers to offer rebates to insurers and employers by denying coverage through formulary exclusions, impeding physician prescription through prior authorization, and reducing patient drug use through cost sharing. As they tighten these access obstacles, PBMs reduce the net prices received by the manufacturers.

Recently, Congress has focused on reforms to address pharmacy benefit managers’ (PBMs) role in high drug prices for patients. Congress must not excessively restrict PBMs’ ability to negotiate with manufacturers; alternatively, reforms could be paired with other policies that address the high prices of brand-name drugs.

Kesselheim proposes doubling the NIH’s budget to promote clinically meaningful pharmaceutical innovation. Since the effects of a previous doubling (from 1998-2003) were mixed, I argue that policymakers should couple future budget growth with investments in experimentation and evaluation.

In January 2023, Moderna announced its intent to increase the price of the COVID-19 vaccine it co-developed with the National Institutes of Health (NIH) by 400%. The federal government should pressure Moderna to change course and resume buying doses for all Americans, leveraging its purchasing power to obtain a fair price.

This study assesses Latin America and Caribbean countries’ capacity to innovate new pharmaceuticals, defined as developing new drugs and vaccines, repurposing existing drugs, and inventing around patents to produce new drug variations. Vaccine innovation includes reengineering existing vaccines, developing new manufacturing methods, and the clinical development of unapproved vaccine candidates initiated elsewhere.

Cuba faces a dilemma between continuing its current portfolio of biotechnology drugs and vaccines with lower profitability or renewing its product portfolio with the associated costs and risks.