Health Law and Policy Commons^™

Du Statut Juridique De L’Embryon Humain En Droit Libanais, Roula El-Husseini Begdache

Proche-Orient, Études juridiques

The legal status of the human embryo has not been specifically studied in Lebanon and is the subject of an uncertain regime resulting from scattered texts and very few court decisions. As the moment marking the beginning of human life remains debated, the recent issues relating to bioethics accompanying scientific advances, particularly in relation to reproductive medicine techniques and their corollaries, including surplus embryos, do not find clear-cut answers in Lebanese law. As scientific progress is at the heart of concerns relating to human life before birth, an abdication of legal experts in favour of doctors and ethics committees can …

Perspectives On Choice Of Law Challenges In Multistate Precision Medicine Research, Laura M. Beskow, Catherine Hammack-Aviran, James W. Hazel, Leslie E. Wolf

Law Faculty Scholarship

This empirical legal study investigates challenges related to determining applicable law in multistate precision medicine research. Through interviews with experts in law, research ethics, and human subjects protections, the authors examine how differences in state laws governing research, genetic privacy, and data protection may affect participant rights and research practices. Interviewees reported varying levels of awareness regarding state law variation and expressed differing views on its significance. The findings suggest that uncertainty surrounding applicable legal frameworks can complicate research design, informed consent processes, and institutional oversight. The study calls for further legal and policy analysis to address these challenges and …

Rest In The Mourning: Navigating Assisted Suicide And Autonomy, Jada Rhome

Journal of Law and Health

Life, in all its diversity, has always been revered for its beauty, be it in the myriad opportunities it presents, the relationships we forge, or the cyclical changes that shape our journey. Yet, life’s harsh winters, those prolonged periods of suffering, often push the boundaries of endurance, prompting the question: Should we insist on perseverance when the hope of relief seems distant? This paper aims to explore this very question in the context of assisted suicide. This paper delves into the intricate ethical landscape of assisted suicide, navigating the complex interplay between autonomy, dignity, and the sanctity of life. At …

Tug Of War Between Opt-In And Opt-Out Organ Donation Systems, Amna Cehaja

DePaul Journal of Health Care Law

The demand for organ transplants is far greater than the supply of transplantable organs. Every day, twenty people in the United States die as they await an organ transplant; this equates to roughly 7,300 people annually. Whilst organ donation can be highly effective for prospective patients, not all individuals want to take part in such an action. A person’s decision not to partake in organ donation can stem from their ethics, morality, religion, and much more. For individuals that live in the United States and do not want to donate their organs upon death, they do not have to take …

Psychedelic Medicine Exceptionalism, Mason Marks, I. Glenn Cohen

Scholarly Publications

Research on psychedelic medicines is experiencing a revival. Some clinicians, scientists, and ethicists believe that psychedelics are so different from other treatments that they warrant special consideration in how they are researched, regulated, commercialized, and administered. Others argue that psychedelic medicines show clinical potential, but they should be treated like other medical interventions. In other words, identical standards should apply. This article analyzes whether psychedelic medicines warrant special consideration from a regulatory and ethical perspective.

Medicare Drug Price Negotiations: A Blueprint For Ethical Pricing Across The Healthcare System, Jacqueline Fox

FIU Law Review

In a healthcare system with scarce resources, profit that exceeds the value of what is being paid for cries out for justifications. The Medicare Drug Price Negotiation Program, created by the Inflation Reduction Act of 2022, is a new program that allows Medicare to begin negotiating with drug companies to determine the maximum fair price for a small set of drugs. This Article argues that the methods for conducting these negotiations represent a significant step forward in a dramatic and important reordering of how we view the healthcare financing system, allowing us to consider rational, coherent concepts of value without …

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 …

Introduction—Bioethics After Dobbs, James Toomey

Pace Law Review

No abstract provided.

Synthetic Health Data: Real Ethical Promise And Peril, W. Nicholson Price Ii, Daniel Susser

Other Publications

Modern health research and development faces a dilemma. On the one hand, there is more data than ever — in electronic health records, in lab research, in public datasets, and on the internet — from which to extract potentially transformative scientific insights and to use as the basis for developing breakthrough health care technologies. On the other hand, using this data entails various risks: threats to patient privacy, skewed samples and approaches to analysis that can perpetuate demographic and other biases, and uneven access to data about rare conditions and small patient subgroups. Generating synthetic data has emerged as one …

Making The World Safer And Fairer In Pandemics, Lawrence O. Gostin, Kevin A. Klock, Alexandra Finch

Georgetown Law Faculty Publications and Other Works

Global health has long been characterized by injustice, with certain populations marginalized and made vulnerable by social, economic, and health disparities within and among countries. The pandemic only amplified inequalities. In response to it, the World Health Organization and the United Nations have embarked on transformative normative and financial reforms that could reimagine pandemic prevention, preparedness, and response (PPPR). These reforms include a new strategy to sustainably finance the WHO, a UN political declaration on PPPR, a fundamental revision to the International Health Regulations, and negotiation of a new, legally binding pandemic agreement (popularly called the “Pandemic Treaty”). We revisit …

Fair Allocation Of Scarce Therapies For Coronavirus Disease 2019 (Covid-19), Govind C. Persad, Monica E. Peek, Seema K. Shah

Sturm College of Law: Faculty Scholarship

The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for monoclonal antibodies (mAbs) for nonhospitalized patients with mild or moderate coronavirus disease 2019 (COVID-19) disease and for individuals exposed to COVID-19 as postexposure prophylaxis. EUAs for oral antiviral drugs have also been issued. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future variants (e.g., the Omicron variant) emerge, further rationing may be required. We identify relevant ethical principles (i.e., benefiting people and preventing harm, equal concern, and mitigating health inequities) …

What The Harm Principle Says About Vaccination And Healthcare Rationing, Christopher Robertson

Faculty Scholarship

Clinical ethicists hold near consensus on the view that healthcare should be provided regardless of patients’ past behaviors. In classic cases, the consensus can be explained by two key rationales—a lack of acute scarcity and the intractability of the facts around those behaviors, which make discrimination on past behavior gratuitous and infeasible to do fairly. Healthcare providers have a duty to help those who can be helped. In contrast, the COVID-19 pandemic suggests the possible recurrence of a very different situation, where a foreseeable acute shortage of healthcare resources means that some cannot be helped. And that shortage is exacerbated …

Narrative Capacity, James Toomey

Elisabeth Haub School of Law Faculty Publications

The doctrine of capacity is a fundamental threshold to the protections of private law. The law only recognizes private decision-making—from exercising the right to transfer or bequeath property and entering into a contract to getting married or divorced—made with the level of cognitive functioning that the capacity doctrine demands. When the doctrine goes wrong, it denies individuals, particularly older adults, access to basic private-law rights on the one hand and ratifies decision-making that may tear apart families and tarnish legacies on the other.

The capacity doctrine in private law is built on a fundamental philosophical mismatch. It is grounded in …

Genetically-Engineered Begots, Have-Nots, And Tinkered Tots: (High Scoring Polygenic Kids As A Heredity-Camelot)-An Introduction To The Legalities And Bio-Ethics Of Advanced Ivf And Genetic Testing, Barbara Pfeffier-Billaeuer

Chicago-Kent Law Review

No abstract provided.

Age—Not Sex Or Gender—Makes The Case Of Ellie Anderson Complex, Elizabeth Lanphier, Shannon Fyfe

Scholarly Articles

In ’The Complex Case of Ellie Anderson’, Joona Rasanen and Anna Smajdor raise several ethical questions about the case. One question asks, but does not answer, whether Ellie faced discrimination for being transgender when her mother was not allowed access to Ellie’s sperm following her death. In raising the question, the authors imply anti-trans bias may have influenced this determination. However, this inference is not supported by current ethical and legal guidance for posthumous use of gametes, with which Ellie’s case is consistent. We consider the authors’ responses to their other ethical queries, and how their suggestions for what options …

Errors In Converting Principles To Protocols: Where The Bioethics Of Us Covid‐19 Vaccine Allocation Went Wrong, William F. Parker, Govind C. Persad, Monica E. Peek

Sturm College of Law: Faculty Scholarship

For much of 2021, allocating the scarce supply of Covid-19 vaccines was the world's most pressing bioethical challenge, and similar challenges may recur for novel therapies and future vaccines. In the United States, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) identified three fundamental ethical principles to guide the process: maximize benefits, promote justice, and mitigate health inequities. We argue that critical components of the recommended protocol were internally inconsistent with these principles. Specifically, the ACIP violated its principles by recommending overly broad health care worker priority in phase 1a, using being at least seventy-five …

Addressing Choice Of Law Challenges In Multi-State Precision Medicine Research: Experts' Assessment Key Factors, Leslie E. Wolf, Erin Fuse Brown, Roxanne Greeson, Catherine Hammack-Aviran, James W. Hazel, William Rencher, Laura M. Beskow

Law Faculty Scholarship

This article explores potential frameworks for resolving choice-of-law challenges in multi-state precision medicine research. Through expert workshops involving legal scholars and research ethics specialists, the study identifies key factors relevant to determining which state laws should apply when research spans multiple jurisdictions. Participants emphasized the importance of considering the location of research institutions, participant residence, and the site of potential harm. The discussion also examined potential solutions including federal legislation, model state laws, and centralized databases of relevant statutes. The findings highlight the complexity of legal governance in large-scale biomedical research and propose strategies to improve clarity and consistency in …

Righting Health Policy: Bioethics, Political Philosophy, And The Normative Justification Of Health Law And Policy, D. Robert Macdougall

Publications and Research

In Righting Health Policy, D. Robert MacDougall argues that bioethics needs but does not have adequate tools for justifying law and policy. Bioethics’ tools are mostly theories about what we owe each other. But justifying laws and policies requires more; at a minimum, it requires tools for explaining the legitimacy of actions intended to control or influence others. It consequently requires political, rather than moral, philosophy. After showing how bioethicists have consistently failed to use tools suitable for achieving their political aims, MacDougall develops an interpretation of Kant’s political philosophy. On this account the legitimacy of health laws does …

How To Compromise On Saving The Most Lives: A Commentary On Hellman And Nicholson, “Rationing And Disability”, David Wasserman

Washington and Lee Law Review Online

Deborah Hellman and Kate Nicholson’s “Rationing Disability” is a skillfully integrated analysis of the legal and ethical challenges of avoiding disability discrimination in setting priorities for the allocation of scarce lifesaving resources. Their analysis goes beyond the important but narrow question of what it means to wrongfully discriminate against people with disabilities in this context to the broader question of how to find a principled compromise between the consequentialist goals of public health and the potentially conflicting public value of “equal concern and respect” for each person. I will focus on this broader issue.

I agree with much …

How Analogizing Socio-Legal Responses To Organ Transplantation Can Further The Legalization Of Reproductive Genetic Innovation, Myrisha S. Lewis

Faculty Publications

The Nobel Foundation emphasized the significance of genetic innovation to society, science, and medicine by awarding the 2020 Nobel Prize in Chemistry to “the CRISPR/Cas9 genetic scissors.” This Article focuses on “reproductive genetic innovation,” a term that includes cytoplasmic transfer, mitochondrial transfer, and germline or heritable gene editing techniques that are all categorized as “experimental” in the United States. These techniques all use in vitro fertilization, a legal and widely available practice. Yet reproductive genetic innovation has resulted in controversy and numerous barriers including a recurring federal budget rider, threats of federal enforcement action, and the unavailability of federal funding. …

Rationing In The Time Of Covid And The Perils Of Anti-Subordination Rhetoric, Mark Kelman

Washington and Lee Law Review Online

With surges in COVID-19 cases threatening to overload some hospital facilities, we must face the possibility that therapeutic treatments will need to be rationed, at least in some places. I do not propose any particular ideal rationing scheme but caution strongly against adopting a position that Professor Bagenstos advocated this past spring, rejecting rationing on the basis of patient life expectancy simply because life expectancy based rationing might threaten the factual interests of those with disabilities and might conceivably be implemented by those making judgments that were not simply inaccurate but grounded in biased, unacceptably discriminatory intuitions that some decision …

Social Justice, Civil Rights, And Bioethics, Kathy Cerminara

Faculty Scholarship

A stunning confluence of events in the United States in the first few months of 2020 have illustrated pervasive systemic prejudice against vulnerable people resulting in increased risk of death. Combined and situated among other, similar incidents too numerous to mention here, they present an opportunity for bioethicists to help change the impact of implicit bias, white privilege, and prejudice in shaping the very ability to live a healthy life in America. The current lack of care and even outright cruelty rendering a variety of vulnerable populations susceptible to early death illustrate why there must be more attention paid to …

"As Long As I'M Me": From Personhood To Personal Identity In Dementia And Decision-Making, James Toomey

Elisabeth Haub School of Law Faculty Publications

As people, especially older people, begin to develop dementia, we confront ethical questions about when and how to intervene in their increasingly compromised decision-making. The prevailing approach in philosophically-inclined bioethics to tackling this challenge has been to develop theories of “decision-making capacity” based on the same characteristics that entitle the decisions of moral persons to respect in general. This Article argues that this way of thinking about the problem has missed the point. Because the disposition of property is an identity-dependent right, what matters in dementia and decision-making is an individual’s personal identity with their prior self, not their moral …

Re-Emphasizing African Bioethics In Light Of Potential Crispr-Based Treatment For Hiv And Sickle Cell Disease, Taylor Daniel

Vanderbilt Journal of Transnational Law

Recent genetic studies indicate that CRISPR-Cas9, a biological gene-editing mechanism derived from bacteria, may be capable of curing HIV and Sickle Cell Disease. Clinical research for HIV and SCD is prevalent in African nations because of the high incidence of those diseases in all forms. Because past research studies in Africa demonstrate how Western companies can abuse lax ethics regulations in developing African nations, ethics systems must prevent this new, potentially far-reaching CRISPR technology from being prematurely and unethically used on African research participants. In updating current international bioethics frameworks, drafters should pay particular attention to its application in African …

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …

Legislative Options To Address Institutional Objections To Voluntary Assisted Dying In Australia, Ben P. White, Lindy Willmott, Eliana Close, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Voluntary assisted dying is being considered by parliaments and law reform bodies across Australia. Although individual conscientious objection is routinely considered in these deliberations, an institution’s desire to object to providing voluntary assisted dying has received very little attention. After briefly considering the concept of institutional objection in voluntary assisted dying, this article examines the available (albeit limited) Australian evidence on this practice. Institutional objection is happening in Victoria (where voluntary assisted dying is lawful) and is likely to occur in other Australian states. The article proposes that regulation is needed and presents three models for parliaments and law reformers …

Medicalization And The New Civil Rights, Craig Konnoth

Publications

In the last several decades, individuals have advanced civil rights claims that rely on the language of medicine. This Article is the first to define and defend these “medical civil rights” as a unified phenomenon.

Individuals have increasingly used the language of medicine to seek rights and benefits, often for conditions that would not have been cognizable even a few years ago. For example, litigants have claimed that discrimination against transgender individuals constitutes illegal disability discrimination. Others have argued that their fatigue constitutes chronic fatigue syndrome (which was, until recently, a novel and contested diagnosis) to obtain Social Security disability …

Medical Civil Rights As A Site Of Activism: A Reply To Critics, Craig Konnoth

Publications

See Craig Konnoth, Medicalization and the New Civil Rights, 72 Stan. L. Rev. 1165 (2020).

See also Rabia Belt & Doron Dorfman, Response, Reweighing Medical Civil Rights, 72 Stan. L. Rev. Online 176 (2020), https://www.stanfordlawreview.org/online/reweighing-medical-civil-rights/; Allison K. Hoffman, Response, How Medicalization of Civil Rights Could Disappoint, 72 Stan. L. Rev. Online 165 (2020), https://www.stanfordlawreview.org/online/how-medicalization-of-civil-rights-could-disappoint/.

Transparency Trade-Offs Priority Setting, Scarcity, And Health Fairness, Govind Persad

Sturm College of Law: Faculty Scholarship

This chapter argues that rather than viewing transparency as a right, we should regard it as a finite resource whose allocation involves tradeoffs. It then argues that those tradeoffs should be resolved by using a multi-principle approach to distributive justice. The relevant principles include maximizing welfare, maximizing autonomy, and giving priority to the worst off. Finally, it examines some of the implications for law of recognizing the tradeoffs presented by transparency proposals.

The Future Of Physicians’ First Amendment Freedom: Professional Speech In An Era Of Radically Expanded Prenatal Genetic Testing, Wynter K. Miller, Benjamin E. Berkman

Washington and Lee Law Review

This Article explores the First Amendment questions prenatal whole genome sequencing (PWGS) is likely to raise. It argues that most of the foreseeable options for state intervention in conversations between physicians and prospective parents about genetic sequencing should trigger at least heightened scrutiny. Part I provides an overview of the most recent advances in genetic testing. It assesses the ongoing impact of non-invasive prenatal testing (NIPT) for providers and patients and charts the course from NIPT to PWGS. Part II establishes a foundational background for evaluating First Amendment claims. Part II.A describes the development of First Amendment jurisprudence, focusing on …