The law governing access to health care has been in flux and in legal dispute in recent years. This course will examine America's programs for health care access and finance, including employment-based private insurance, Medicare, Medicaid, CHIP, and VA. The course will also examine the enactment, implementation, and litigation of the Affordable Care Act. In addition to these payment systems, the course will also at laws affecting non-comprehensive systems such as emergency rooms, public hospitals, and community health centers. No previous knowledge of health law is required.

The course will look at the legal treatment of reproductive rights in early America through the mid-1800’s and to the legalization of abortion. We will examine how we got from Roe v. Wade to Dobbs v. Jackson Women’s Health Care and discuss the legal and practical impact of the Supreme Court’s reversal of Roe, as well as state attempts to ban or restrict abortion. The course will directly address Institutional Learning Objective 8 by requiring students to think critically about the law’s claim to neutrality and its differential effects on subordinated groups, including those identified by race, gender, indigeneity, and class and consider whether one person’s moral or ethical position should prevail when that position has disparate negative impacts on marginalized communities. We will look at how the law is intersecting with issues of race, sex, class, religion, sexual orientation, and politics to shape the culture of the country and our individual lives. The course will conclude with a review of the current legal battles relating to abortion, emergency contraception, assisted reproduction and gender affirming care, and discuss the legal theories at play, which are being used by both sides of the debate in competing iterations.

According to a U.S. Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) 2021 survey, nearly 1 in 3 adults had either a substance use disorder or a mental illness in the prior year, and 46 percent of young adults 18-25 had either a substance use disorder or a mental illness.  Due to the increased prevalence of these chronic disorders, and their nexus to the public health crisis of suicide, opioid addiction, and homelessness, it is critically important for lawyers and advocates to have a strong understanding of behavioral health law from the constitutional to local regulatory level. 

This course is a practice-based seminar that is designed to improve the students’ practical legal skills – writing, analysis, oral communication, issue spotting, and attention to detail – while examining key laws, legal decisions, and policies in Addiction and Mental Health Law.  This seminar will explore the framework of laws and policies promoting human rights, dignity, and recovery for people with substance use disorders and mental health conditions. It will highlight systemic and community responses to addiction, mental health, and related social issues as well as the use of litigation, legislation, advocacy, grants and financial incentives as tools for prevention and reform.

Discussions will include: 

• Institution-based issues such as the involuntary detention and civil commitments of individuals with a serious mental illness, restraint and seclusion, the right to appropriate treatment under Youngberg v. Romeo, institutional reform under 42 U.S.C. § 1983 and Monell v. Department of Social Services of the City of New York, and the Department of Justice’s authority under the Civil Rights for Institutionalized Persons Act;
• Forensic issues such as pretrial competency, Not Guilty By Reason of Insanity, and forced medication for competency purposes under Sell v. United States;
• Community-based issues such as deinstitutionalization, rights of an individual to receive services in the most integrated setting appropriate to their needs, housing discrimination, Medicaid, rulemaking and administrative adjudications under the Administrative Procedure Act, behavioral health provider licensure and regulation, and the False Claims Act; 
• Federal and state/local initiatives such as 911 diversion programs and co-responder law enforcement teams, mental health courts and diversion, harm reduction strategies, e.g. decriminalization of fentanyl testing paraphernalia, federal State Opioid Response grants, rapid rehousing initiations, and liberalization of 42 CFR Part 2 to facilitate increased information sharing for Substance Use Disorder treatment records; 
• Understanding the Triple Aim in healthcare, data, outcome measures, and healthcare finance structures for behavioral health, including Medicaid and commercial insurance; 
• Role of the health care and criminal justice systems and trends in reforms; and
• Cultural competence in legal advocacy and practice.

Guest lectures and discussion will provide real world case studies on laws and policy reforms impacting addiction and mental health.

This seminar explores, through lecture, discussion, role playing, and problem solving, the range of legal challenges and public policy issues affecting older adults. Subject areas include health care benefits (Medicare, Medicaid); long-term services and supports (nursing homes, home and community-based services, long-term care insurance, state-based programs); income security programs (Social Security, SSI); aging and autonomy, including elder abuse, neglect and exploitation and advance planning related to incapacity (powers of attorney, guardianship and its alternatives, choices regarding life-sustaining medical treatment); housing and consumer issues affecting older adults; and ethical issues in representing older adults. Coursework will address systemic inequities faced by older adults of color, older women, LGBTQ older adults, older adults with disabilities, and older adults who are immigrants or have limited English proficiency. The seminar is both practice- and policy-oriented and integrative with respect to other coursework and related disciplines.

Alternative, Complementary, and Integrative Medicine (CAM) is one of the fastest growing sectors of American healthcare. At least 50 percent of Americans are using some form of alternative and complementary therapy such as acupuncture, nutritional supplementation, herbs, massage, yoga, chiropractic, or homeopathy. According to the Journal of the American Medical Association, visits to alternative healthcare practitioners exceeded total visits to all conventional primary care physicians. The number of clinics and hospitals that integrate some modalities of CAM alongside conventional medicine is growing rapidly. The Institute of Medicine, a part of the National Academy of Sciences, Engineering and Medicine, has held recent conferences on the values of both CAM and Integrative Medicine while The National Institutes of Health is using significant resources to fund research in this area.

These developments, of course, are raising legal issues. There is a growing but still unsettled body of law on this subject. Some but not all CAM modalities are now licensed and regulated by at least some states. Federal regulatory bodies, such as the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), are trying, within the limits of statutory authority, to protect what officials perceive to be the interests of the public. Yet, they come at the problem through conventional, rather than alternative, eyes. Conventional law is based upon protecting the public from purveyors of proverbial "snake oil" frauds. And, to an extent, the law is being used to keep out alternatives to the established healthcare modalities. This seminar studies the tensions -- legal, economic, and social -- of this struggle as it unfolds. This seminar also covers several areas of law, including administrative law, medical malpractice, informed consent, FDA/FTC law, and licensure, among others, and addresses the tension between government paternalism and individual rights in the United States. A paper meeting the upper class legal writing requirement is required.

Globalization has inevitably forced lawyers, public health professionals, health care professionals, and anthropologists alike to rethink the traditional approaches and methods relied upon within their disciplines. As international borders continue to disappear and countries and people throughout the world become increasingly interconnected and interdependent, public health threats can easily become global in scale and can only be properly addressed through multidisciplinary efforts at global, national, and local levels. Time and time again, the implementation of sound public health measures has proven difficult in communities when local culture and ideology are not considered or properly understood. As governments and international organizations increasingly rely on the law as a fundamental tool for solving critical health problems, it is of the utmost importance that the laws and regulations that they adopt with the aim of protecting and advancing population health, as well as their implementation, properly reflect the social and cultural context of those affected.

Through the analysis of case studies from various areas of global health (including non-communicable diseases, infectious diseases, climate change and health, and gender and health), this course aims to underscore the importance both of incorporating anthropological methods into the practice of global health law and of utilizing a multidisciplinary approach when addressing global health challenges.

This 2 or 3 credit seminar will provide an overview of the underlying and competing laws and policies arising from the assisted reproductive technologies (ARTs) that continually make front page news. Since the 1980 opening of the country’s 1st IVF clinic amidst protests and pickets, courts and legislatures have struggled to create laws and policies in response to continually evolving reproductive advances. Topics will include: the legal status of the IVF embryo in the context of procreative rights (highlighted by the currently changing and challenging legal context); embryo cryopreservation, storage, disposition and mix-ups; legal implications of advances in egg freezing, reproductive genetics and oncofertility; posthumous reproduction; egg and sperm donation; traditional/genetic and gestational surrogacy; unique issues for single and same-sex couples, including the impact of legally recognized same-sex marriage; and professional and regulatory aspects of the ARTs.

Two classes that will examine selected legal and policy aspects of comparative ART law perspectives on “third-party ART” and the impact these differences have on cross-border reproductive practices, with a particular focus on surrogacy.

National experts in their respective fields will provide guest lectures on: medical advances in ART; psychosocial aspects of donor egg and 3rd party ART;  reproductive genetics; and potentially other emerging developments. 

“Three generations of imbeciles are enough.” These infamous words from the United States Supreme Court’s 1927 decision in Buck v. Bell are what most people think of regarding the right to bear children for those with disabilities. Tragically, Buck has never been explicitly overturned in the United States, and its legacy is reflected in the continued reproductive oppression of people living with intellectual disabilities. With the overturning of Roe, in some states, the disability status of the fetus remains one of the few exceptions to abortion access. The intersection of reproductive health, rights, and justice with the issue of disability is an area ripe for analysis and exploration.

A Reproductive Justice analysis of the right to have children, not have children, and to raise children yields a fascinating, complex, and ever-developing landscape of the privileges and responsibilities of those with both physical and intellectual disabilities, both in the U.S. and globally. The class will define Reproductive Justice and Disability Justice, and provide a brief history of the movement from the paternalistic treatment of people with disabilities, to efforts to respect, protect, and promote their autonomy and human rights.

The remainder of the course will examine the legal, policy, moral, and ethical issues at the intersection of disability and reproductive justice. The course will take an interdisciplinary approach, incorporating various bodies of law (ethics, family law, welfare policy, criminal law), historical analysis, social science, and current events. We love suggestions for topics or readings. This is an ever-evolving area, and we want to make it as relevant to your interests as possible. Please don’t be shy!

This seminar explores legal, ethical, and social issues raised by developments in health, medicine, and the biological sciences at the U.S. and global levels. It first provides an overview of the normative theories that inform the development of the field of bioethics, as well as connects these theories to legal and social dynamics that continue to shape discussions of equity and justice. It then considers a spectrum of priority topics and themes, through both a theoretical and practical lens, such as end-of-life issues, reproductive rights, human subjects research, access to medicines, and vaccines. Students will develop an in-depth perspective on how law and ethics overlap and shape the discourse on these priority topics. This seminar will be especially informative for students looking to obtain a practical view into how the law interacts with ethical dilemmas in health, medicine, and science.

Learning Objectives:

• Describe the normative theories that inform the development of the field of bioethics and the role that the law has played in this evolution
• Describe practical examples of legal and ethical dilemmas that arise across multi-disciplinary topics in health, medicine, and the biological sciences
• Articulate the ethical arguments on often opposing sides of priority bioethical issues, understanding the varied levels of nuance involved
• Analyze the role of legal institutions and law and in creating a framework to address the ethical, legal, and social issues that arise in the fields of health, medicine, and the biological sciences

This seminar explores legal, ethical, and social issues raised by developments in health, medicine, and the biological sciences at the U.S. and global levels. It first provides an overview of the normative theories that inform the development of the field of bioethics, as well as connects these theories to legal and social dynamics that continue to shape discussions of equity and justice, including on the global stage. It then uses several in-class simulations to explore the practical challenges—both legal and ethical—that arise for counsel practicing in this field. The simulations are designed for students to “step into the shoes,” as it were, of different actors, from in-house counsel at an academic medical center to the United States Ambassador to the United Nations, to gain practical insight into real-world situations. This seminar will be especially informative for students looking to obtain a practical view into how the law interacts with ethical dilemmas in health, medicine, science, and politics.

Learning Objectives:

• Describe the normative theories that inform the development of the field of bioethics and the role that the law has played in this evolution
• Describe practical examples of legal and ethical dilemmas that arise across multi-disciplinary topics in health, medicine, and the biological sciences
• Articulate the ethical arguments on often opposing sides of priority bioethical issues, understanding the varied levels of nuance involved
• Analyze the role of legal institutions and law and in creating a framework to address the ethical, legal, and social issues that arise in the fields of health, medicine, and the biological sciences

This is a survey class, examining issues ranging from drug regulation, clinical trials, assisted reproductive technology, telemedicine, and stem cell development/regulation to the commercialization of the human body.  For this class we will use the Biotechnology, Bioethics, & The Law Casebook (Goodwin, et. al., eds).  This course requires substantial reading, preparation, organization, and the ability to analyze subtle nuances between various judicial decisions, legislative enactments, ethics, and legal rules, which sometimes may seem in conflict.     

In this class, we will examine whether emerging biotechnological conflicts are best resolved by regulation, judicial intervention, or private negotiation.  Professor Goodwin encourages robust dialogue.  As such, students should come to class prepared with their ideas, intuitions, and opinions.  Their analysis should demonstrate a grasp of the materials.   Students are expected to discuss the materials, act responsibly toward their peers, as well as conduct themselves in a professional manner.  There are no prerequisites for this course. However, students must be prepared for rigorous discussions and substantial reading assignments.  This course is a building block for the other courses in ethics, health law, and a law and science curriculum, including Patents, Food & Drug Law, Health Regulations, and Bioethics. The core competencies expected in this class are critical thinking and the application of social, legal, moral, and economic reasoning.

Much of the reading assigned for class will be covered during discussion.  However, some assigned readings may not be covered given limited class time.  Nonetheless, students are responsible for all reading materials.  The readings include excerpts from medical journals, regulations, cases, newspapers, and social science periodicals.

Course Goals

The goals of this course are to:

• Introduce students to the study of biotechnological developments, health policy, and ethics;
• Familiarize students with the medical and legal literature on the topic;
• Engage students with practical as well as theoretical ideas in biotechnology law;

• Stimulate intellectual curiosity about the subject matter;
• And inspire critical thinking and thoughtful analysis.

Corporations today have a global scale as well as an impact that matches or sometimes exceeds that of governments. Their activities -- from sourcing of raw materials, to processing and production of intermediate or finished goods, to distribution and sale -- have major consequences not only for the human rights of their employees but also for the rights of the individuals and communities impacted by their operations.

The international trade deregulation and liberalization policies from the 1970s-90s that drove globalization -- including competition among governments for investment -- created “governance gaps” where government regulation and oversight of corporations was either absent or largely ineffective. High profile incidents of corporate actors adversely affecting workers and/or communities in circumstances in which no remedy was readily attainable drew attention to these gaps and the need for clarity about the respective roles and responsibilities of governments and businesses. 

These controversies revealed the need for a fundamental shift in conceptions of the roles and responsibilities of different actors under international human rights law. In this context, the United Nations, under the leadership of the late Special Representative John Ruggie led a nearly seven-year process culminating in the development of the U.N. Guiding Principles on Business and Human Rights (“UNGPs”). The UNGPs, unanimously endorsed by the U.N. Human Rights Council in 2011, established a framework for considering the respective roles of governments and corporations and outlined core concepts of human rights due diligence and effective remedy. The corporate responsibility to “respect” human rights is now widely recognized as the expected standard of conduct for business enterprises.

BUSINESS AND HUMAN RIGHTS IN THE GLOBAL ECONOMY SPRING 2026

In the 14 years since the UNGPs were adopted, much of the focus has been on voluntary approaches to addressing business and human rights challenges guided by the framework set forth in the Principles. At the government level, this has included the preparation of National Action Plans to coordinate cross-agency policies, with a focus on trade, investment and procurement related tools to exercise greater leverage over corporate behavior. For companies, this has included the development of human rights policies and governance structures and the integration of human rights due diligence into business decision-making. Looking back over the last decade, many stakeholders have been frustrated by the largely incremental and piecemeal progress made by both governments and companies in implementing the UNGPs, as well as by challenges associated with fragmented national approaches. Most recently, the European Union and a number of national governments have adopted mandatory human rights and environmental due diligence measures.

This course introduces students to this rapidly-evolving business and human rights landscape, including the diverse set of multi-stakeholder initiatives -- some, but not all, of which include government participation. We will discuss: the guidance provided by the UNGPs and other instruments; different key stakeholder groups and how they engage with one another; tools utilized by governments and corporations to implement human rights responsibilities and commitments; and how all of these issues interact in the context of both sector-specific and cross-cutting legal and policy challenges. 

Among the central questions the course will examine are: 

●  What are the sources of international human rights standards and which human rights standards are most relevant to business? 

●  What are the appropriate linkages between business policies and the promotion of human rights?

●  Which business and human rights “self-regulatory” approaches are emerging as “best practices” and even as recognized norms?

●  What tools to support those are being used by governments and corporations?

●  Who are the principal stakeholder groups and what are their respective roles and objectives?

●  What have been chief points of contention, as well as the opportunities for collaboration, among different stakeholders?

●  How are various emerging mandatory human rights due diligence measures, as well as sector- or issue-specific initiatives addressing business and human rights “governance gaps”?

●  What are the strengths and limitations of various regulatory and “self-regulatory” approaches utilized in different situations to advance human rights objectives?

●  How are various business and human rights challenges playing out in specific sectors, and how do these inform the debate about different approaches? 

To address these and other key questions, the course will begin in Weeks 1-3 by setting out the relevant legal and policy developments, with special attention to the UNGPs. Week 4 will then focus on a review of different stakeholders and their roles and interests, an examination of concepts of corporate responsibility and corporate accountability (including with respect to access to remedy, the third pillar of the UNGPs), and an analysis of the various approaches to business and human rights advanced by governments, companies, investors, labor, civil society, and through multi-stakeholder initiatives. 

The remainder of the semester will then focus on how these concepts are being applied, looking at the key themes of global corporate value chains, emerging technologies, and climate change. We will assess approaches taken within different industry sectors, and the actions of other key stakeholders, to identify and address specific human rights challenges.

Throughout the course, students will be asked to examine the various approaches and differing roles of stakeholders, including by playing the roles of those addressing issues from the perspectives of corporations, civil society and unions, and governments. The class will be divided into three groups for purposes of this “role playing” -- with each asked to adopt all three perspectives during the semester, both in students’ individual analyses of assigned readings and in group sessions during certain classes.

Learning Objectives:

Introduction to business and human rights landscape, including legal and policy developments, particularly the UN Guiding Principles on Business and Human Rights. The course reviews different stakeholders and roles, examines concepts of corporate responsibility and accountability, and analyzes various approaches to business and human rights advanced by stakeholders. The course will also familiarize students with sector specific business and human rights challenges.

The relationship between business, human rights, and sustainability has gained momentum in recent years with the private sector, governments, civil society, and international organizations, owing largely to the passage of the United Nations Guiding Principles on Business and Human Rights (UNGP) in 2011, the 2012 UN Rio + 20 Sustainable Development Conference and the UN Sustainable Development Goals (2015). These developments were preceded and followed by a series of multi stakeholder (governments, private sector, investors, civil society networks and organizations) and specific industry driven initiatives looking at how to integrate these international standards into both self and binding regulatory processes. As a result, many of these initiatives led to an emerging international soft law system of business, human rights and sustainability that is based in the internationally acknowledged body of hard law principles.

Regardless of being industry, sector specific or multi stakeholder in nature, the regulation, de-regulation, policy, practice and ever growing global litigation in this new field of practice is multifaceted, dynamic, interactive, complex and challenges business leaders, markets and even lawyers to think outside the box in order to address a challenging relationship between business, markets and society. This is where business strategy meets risks. Or instead, this is where risks eat a business strategy.  As a result, business leaders, shareholders and their advisors are now required to integrate a 3D internal and external view and assessment on how to address, prevent, mitigate and remediate the social and environmental impacts (risks) of private sector operations in complex environments and with a collaborative and systems thinking approach.

Bar Associations in America and abroad have begun issuing specific guidance on how corporate lawyers should advice their clients incorporating human rights and sustainability standards. For instance, in a Mergers and Acquisitions (M&A) transaction, corporate lawyers are most likely to encounter questions dealing with social, environmental, human rights and environmental concerns. Those advocating on behalf of environmental and human rights organizations will find their work directly intersects with company law, securities law, investment law, governance, compliance, company law and alternative dispute resolution mechanisms to name a few sub areas.

Fast-forward 2020. The global COVID-19 pandemic has suddenly entered this space. It has done so highlighting the vulnerabilities and opportunities in the relationship between business, governments and society across the globe. Furthermore, the global pandemic is challenging all stakeholders not only to become relevant but to re-think, re-imagine and re-envision new models that seek engagement, resilience, addressing grievances, investment, economic recovery and accountability frameworks.

In practice, these global and ever growing litigation trends are also challenging traditional company-led corporate social responsibility (CSR) and ethics programs that have been associated with both philanthropic, corporate citizenship and company-sponsored activities that give back to societies. While many of these programs have achieved several levels of success, for many sectors in society they remain as corporate public relations or green wash exercises and demand more transparent, accountable and remediation responses.  The stakes are high.

Litigation, a growing movement towards mandatory human rights and environmental due diligence and reporting requirements and other types of social demands are challenging companies to be very purposeful and accountable on how they address the environmental, social and governance negative impacts (for some) or violations (for others) of their operations globally and domestically. Stakeholders are asking companies to integrate ongoing due diligence processes that address materiality concerns when it comes to managing supply chains and making sure they are free of child labor, modern slavery and human trafficking. They are also asking companies to address the social and environmental impacts of extraction of natural resources above and below ground, to name a few. 

Furthermore, stakeholders are not alone on this. The emerging and growing movement of shareholder advocacy is leading the way across industries and pushing the way through different strategies for more corporate engagements that drive responsible business conduct and standard-setting activities that push for robust business, human rights and sustainability policies embedded as part of corporate operations across systems and functions. In particular, a wide range of investors that include asset management firms, trade union funds, public pension funds, foundations, endowments, faith-based organizations and family funds are leveraging their assets of over US$3.5 trillion to collaborate around responsible investment while influencing boards and management.

At the conclusion of this course, students will demonstrate the capability:

• To distinguish between relevant applications of the Business, Human Rights and Sustainability frameworks of international hard and soft laws, in the context of environmental, social and human rights challenges across industries and different actors and how they can be integrated into the business strategy.
• To assess critical human rights, environment and natural resources challenges currently faced by industries and markets in different contexts through a multi stakeholder and 3D lens risk management approach.
• To analyze and discuss how different tools and resources can be applied and be relevant to address human rights and environmental challenges, which tools would be best suited for specific contexts and grievance mechanisms that exist for access to remedy across relevant and selected industries (policy development, stakeholder forums and facilitation, influence and development, multi stakeholder assessments, human rights due diligence and environmental assessments) in international development, conflict and post-conflict environments.

The history of global health is inextricably linked to colonial conquest. The early interventions of what was then called international health were developed within colonial settings and to a large degree, were dependent on the coercive power of colonial rule. Shaped by colonial ideas that colonized peoples were incapable of improving their own health, the existence of local medical knowledge and existing public health infrastructures in colonized lands were subverted and colonial health services were designed primarily to protect the health of European and American personnel who were essential to upholding the colonial economy.” (Zeinabou Niamé Daffé et al, 2021)

COVID-19 has demonstrated that the modern global health systems, built on the foundations of colonialism, continue to perpetuate practices and laws that often result in inequitable access to health services and products, and unequal enjoyment of the right to health. Created on the foundations of tropical medicine. The Special Rapporteur on the Right to Health, Dr. Tlaleng Mofokeng, has made decolonizing human rights in global health an integral part of her mandate and to that end has proposed the idea of a forthcoming Lancet O’Neill Commission on Racism and Structural Discrimination in Global Health Law.

The course will provide a historical context to students of the impact of racism and colonization on modern day global health. It will examine the historical role of the law in entrenching racially discriminatory health law and polices, and examine the opportunities for reform through the work of the forthcoming Lancet O’Neill Commission on Racism and Structural Discrimination in Global Health, co-chaired by Dr. Tlaleng Mofokeng and Dr. Ngozi Erondu.

Human rights are humanity's greatest ethical, moral, and legal capital. Seventy-five years ago, reeling from the devastation of world war, States came together to agree on a blueprint for preventing future cataclysms—respect for human rights—and codified that plan in foundational documents like the American Declaration of the Rights and Duties of Man and the Universal Declaration of Human Rights. The rights detailed in the UDHR—which encompass civil and political rights, like the right to free expression and a fair trial, and economic, social, and cultural rights, like the right to adequate food and housing—were seen as interdependent, indivisible, and mutually reinforcing: no right should be privileged above another.

But it wasn’t long before the ideological divide of the Cold War fractured this consensus, with the West generally prioritizing civil and political rights and the Soviet bloc generally emphasizing economic and social rights.

This course will explore the negative impact of that artificial division, which resulted in the demotion of economic, social, and cultural rights (ESCR) to “second generation” rights, with scant enforceability and justiciability, and the urgency of repairing the breach, particularly in the context of the climate emergency. The course will situate economic, social, cultural, and environmental rights (ESCER) in the international and regional human rights systems, with a special focus on the Inter-American system. The course will then examine in detail a number of specific ESCER, with an emphasis on the impact violations of these rights have on women, indigenous people, people of African descent and other populations in situations of vulnerability or historically discriminated against. The course will examine the contours of the right to a healthy environment and will explore the role and responsibilities of business and other economic actors in upholding such rights.

Learning Objectives:

Students will gain a comprehensive understanding of economic, social, cultural, and environmental rights, including current developments and controversies surrounding these rights. Students will be able to identify tools and gaps in the national and international realization of rights such as the rights to clean water and sanitation, health, education, housing, work, and a healthy environment.

The course will also train students to craft persuasive arguments for the legal defense of these rights at national and international levels and to advocate on key issues, such as the climate emergency and the obligation of corporate due diligence.

Students will learn to apply the principles of universality, indivisibility, and interdependence, with a gender and intersectional approach, to the analysis of ESCER.

Students will get a unique insider’s look at high-level advocacy for ESCER. I will share some of my own field experiences during the course and students will also have the opportunity to hear from some distinguished guest speakers.

Finally, this course aims to provide students not only with exposure to the legal principles underlying ESCER but a deep understanding of the impact of violations of these rights on the most historically discriminated populations. Exploration of each course topic will include the perspectives of people and communities most impacted by the lack of access and enjoyment of ESCER. This approach is designed to help build a community of practice and solidarity that will live on beyond the course.

This course covers tax and ERISA aspects of employer-sponsored health and welfare benefit plans. The tax discussion will concentrate on the conditions for favorable tax treatment of health and welfare benefits (and other fringe benefits), the cafeteria plan rules, the applicable nondiscrimination requirements, and the special rules applicable to funded welfare benefits. The ERISA discussion will focus on plan design, reporting and disclosure, claims and litigation procedures, and fiduciary duty rules.

This seminar provides an overview of the principal legal issues impacting the development and commercialization of biopharmaceutical products. It:

• Provides an overview of the structure and operation of the biopharmaceutical industry, including manufacturers of innovator and generic products;

• Explores the principal laws governing the development, sale and marketing of biopharmaceuticals, including relevant portions of the Federal Food, Drug, and Cosmetic Act, the False Claims Act, and the Federal Anti‐Kickback Statute;

• Explores how these laws create liability for both biopharmaceutical companies and their executives for the manner in which such companies price, report prices on, communicate about, and interact with regulators and health care providers about their products;

• Addresses key industry‐specific controversies and issues; and

• Concludes with a table‐top exercise in which students role play the management and resolution of a regulatory crisis.

At the end of the course, students will have a foundational understanding of the biopharmaceutical industry, the federal regulatory rules governing the development, distribution, and promotion of biopharmaceutical products, and areas of ongoing legal debate.  The primary statute of focus for the course is the Federal Food, Drug, and Cosmetic Act of 1938, as amended.  Students will also gain an understanding of the key primary sources in life sciences regulatory law with particular emphasis on legislation regulations, sub-regulatory guidance, and case law applicable to biopharmaceutical products.

This course will introduce students to the foundational laws and policies governing the production and distribution of foods, drugs and medical devices in the United States, focusing on the Federal Food, Drug, and Cosmetic Act (the "Act") and the role of the Food and Drug Administration in enforcing the Act. The course will cover key concepts and definitions -- e.g., "food," "drug," "labeling" -- and federal statutory provisions designed to assure that such products are not adulterated or misbranded. Students will also receive an overview of the different agencies that have jurisdiction over foods, drugs and devices on the state and federal levels, as well as an introduction to the ways in which such agencies exercise their authority through rulemaking, guidance and enforcement activity.

Rules governing food and agriculture can have a dramatic impact on the welfare of farmers, food and farm workers as well as the price of food, access to healthy food, the fate of rural communities, the environment, and animal welfare. This is a fieldwork practicum course that has both 1) a two-credit graded seminar exploring food justice and policy issues and 2) a two- credit fieldwork placement. The fieldwork credits are mandatory pass-fail. 

SEMINAR: This seminar portion of the course will advance the Law Center’s institutional learning outcomes by covering the policies, rules, and laws that govern food and agriculture, including laws and regulations related to farm subsidies, farm stewardship, pesticide safety, food safety, food labeling, food and farm labor, and animal welfare. The extent to which these policies have discriminated against farmers of color and food and farm workers and limited access to healthy food choices will be a major theme of this practicum. Students will have pervasive opportunities to think critically about the law’s claim to neutrality and its differential effects on subordinated groups.

FIELDWORK: In the fieldwork component of this course, students will be assigned to projects with the Environmental Working Group, the Environmental Defense Fund, the Center for Science in the Public Interest, Earthjustice, or other food, farm, worker, environmental justice, and animal justice organizations working on these issues. They will have an opportunity to learn how such institutions play a role in advancing food justice issues being debated in both the administrative and legislative processes, and in matters subject to litigation. Students must work 10 hours per week for 11 weeks for two credits.

This course will provide an introduction to the legal contexts and theoretical debates surrounding sex, gender, sexuality, and their intersections.  We will explore the way gender and sexuality have been debated, defined, and redefined in the contexts of gender identity and performance, sexual pleasure, reproductive rights, sexual violence, marriage, family organization, work, and education.  In these contexts we will consider the evolution of the law, the discursive effects of law, and the ways feminist and queer theorists have challenged and reimagined prevailing legal rules and cultural norms. In short, the class will probe the ways that law is gendered, sexualized, and raced, and with what overall effects on social institutions and practices.

Key topics will include:

• The Mutual Influence of Identitarian Politics and Law 
• Constitutional Law of Sex Equality, Liberty, and Religious Objection
• Regulation of Sexual Conduct
• Regulation of Reproduction
• The Evolving Meanings of Marriage & Family
• Sexual Harm & Consent
• Gender & Sexuality at Work, School and other Institutions

Globalization and the international trade of drugs and medical products have progressed beyond any single regulatory authority’s ability to effectively ensure the quality, safety, and effectiveness of these products. In the U.S., the importation of foreign sourced products has increased tremendously, accounting for over 80% of the active pharmaceutical ingredients. However, varying drug regulations have resulted in gaps in oversight causing differing views on the acceptable level of risk in public health leading to drug quality related deaths and other serious harms. One clear reason for this compromised system is the differences in how these products are regulated from country to country. Nevertheless, the pharmaceutical and related industries are thriving in the global marketplace. This course is intended to be the first comparative survey into the regulatory frameworks of certain key countries, both developed and developing markets, along with international institutions, such as the World Health Organization, involved in promoting the access and development of safe, effective and quality medical products. This course will also identify the major international non-governmental stakeholders, and the multi-lateral schemes and treatises in which they operate that are intended to assist in the convergence of pharmaceutical laws and regulations.

Global Health Law is the flagship course offered by Georgetown University Law Center’s O’Neill Institute for National and Global Health Law. This course is open to both Georgetown J.D. and LL.M. students and is compulsory for students in the National and Global Health Law LL.M. and the Global Health Law and Governance LL.M.

The survey course explores the roles that the law, lawyers, and legal institutions play in public health across the globe. Global health law encompasses international law and policy that directly or indirectly affects health, including treaties, regulations, strategies, and expert guidelines. This course provides a strong foundation in these instruments, laws and policies, including topics such as governance of the World Health Organization, Universal Health Coverage, the International Health Regulations, the role of the UN Special Rapporteur on Health, and the proposed accord on  global pandemic preparedness. The course also explores comparative national approaches to health governance, law, and policy.

The course is divided into three modules. Module 1 covers the foundations of global health law, providing overviews of public international law, international human rights law, international trade law, and the intersections between intellectual property law and health. Module 2 covers health systems and governance, including the World Health Organization, and public health ethics and principles. Module 3 addresses the human right to health and other key emerging topics in health law such as environmental law and health, the global campaign for Universal Health coverage, and the use of litigation to advance the right to health. The course culminates in students presenting proposals to reform international law to better protect and promote global and public health outcomes.

Students will hear from leading voices in global health law and benefit from the expertise of the O’Neill Institute for National and Global Health Law, as well as other resources at Georgetown University and in the broader Washington, D.C. community.

Course Goals/Student Learning Outcomes

1. Knowledge of the substantive foundations of global health law, including public international law; human rights law; global health governance; the interface between international trade and intellectual property law and health; and principles of public health law.
2. Knowledge of the legal issues related to a range of global health challenges, including access to health care and prevention and control of non-communicable diseases and infectious diseases.
3. Knowledge of the various roles that lawyers can play in advancing global health, including legal drafting, negotiating, litigation, and advocacy for law reform.
4. Ability to use various skills relied upon by global health lawyers, including legal research, analysis and writing, strategic thinking, and communication. 

In this intensive course, students will work with faculty and fellows at the O’Neill Institute for National and Global Health Law to gain an in-depth understanding of global health law through intensive examination and role play of one or more major problems in global health. Potential problems could include a naturally occurring infectious disease epidemic such as extensively drug-resistant tuberculosis; a future epidemic such as pandemic Influenza (A) H5N1; and/or an intentional introduction of a lethal pathogen such as anthrax. Students should come to this course with a basic level of understanding of international law. When studying and role playing these kinds of problems, students will be asked to construct innovative methods of global health governance, drawing upon existing international health law and institutions, along with a vision for more ideal models.

Full attendance and participation are required at all sessions. Class sessions will consist of a combination of lecture, case simulations, and discussion. Grades are based on student participation and a final paper.

This course analyzes the subject matter of global health security as it is shaped by international agreements and national implementation and preparedness laws. As societies and economies are increasingly interwoven and interdependent, new forms of health security threats have arisen, and nations are now contending with such implications through established agreements like the International Health Regulations (2005). In recent years, the realm of health security has expanded greatly with more governments, companies, and NGOs working to solve problems and pursue opportunities. Most prominently, the COVID-19 pandemic has shattered existing paradigms of stability and security, with ramifications from the global perspective down to that of nearly every world citizen. Over an immersive weekend of overview and interaction, this course highlights prominent threat categories, namely the “3-D threats” of Disaster, Disease, and Disorder. This seminar will be devoted as an active legal laboratory in which student ideas are solicited and shaped with the participation of the class.

The objective of the course is to crystallize student understanding at the international, national, and local legal level, the perspective viewed by national and organizational leaderships, and to frame student thinking by developing a broad, contextual understanding of the situation of health security. The course will draw connections between direct experience with purposeful intent through class exercises. Practical frameworks will be employed to simplify the dynamics within complex situations, and to organize student thinking about actions and options. An overnight simulation activity assessing a humanitarian crisis between the first and second day invites analysis about cause-effect, goals-intentions, and interventions-consequences. The course relies on active participation that feeds a mutual learning environment and that catalyzes and reveals students’ ideas as they occur, thereby fostering an at-the-ready style of nimble thinking and conversing.

This course explores the potential of using the law, and specifically, the human rights legal framework, to improve health. Students will be exposed to real life projects at the domestic level in a number of different jurisdictions, especially but not exclusively from Latin America and Africa; as well as at the regional and international level, including the Inter-American Human Rights System and the United Nations Human Rights System. With this approach, students will strengthen not only their knowledge of the human rights framework within their familiar jurisdictions, but will also have the opportunity to develop comparative legal research skills.

The human rights framework that students will learn in depth in this practicum is not limited to the right to health but involves other related human rights that are also social determinants of health or that are instrumental to the effective realization of the right to health. Therefore, students will be exposed to the substantive expertise needed to successfully practice the strategic use of the integrality of the human rights framework in the specific context of health. Students will also be required to consider the use of other legal frameworks that have the potential of having a positive impact on health outcomes.

The variety of projects will take into consideration the complexity and different dimensions of the right to health as well as the nature of the legal obligations that it imposes in different contexts. We will offer projects that respond to current and pressing global challenges with respect to health, for example, projects exploring the right to health and other rights in the context of public health emergencies, the link between health and the environment, the structural disadvantage that specific groups face with respect to their health and the role of private actors, to name a few.

For the execution of their projects, students will work with external partners of the O’Neill Institute for National and Global Health Law, in particular, the Health and Human Rights Initiative. (“HHRI”).

One-fifth of the U.S. economy centers around health care industry sectors. This seminar examines criminal, civil and administrative tools used by federal and state enforcement authorities to police the U.S. healthcare system. We will focus on cases brought under federal and state False Claims Acts (FCA), the Anti-Kickback Statue (AKS), Stark laws, Federal Food Drug and Cosmetic Act (FDCA), and Foreign Corrupt Practices Act (FCPA). The seminar provides a survey of the enforcement activities of the U.S. Department of Justice (DOJ), the Office of Inspector General at Department of Health and Human Services (OIG), and state Medicaid Fraud Control Units (MFCUs) in matters against pharmaceutical and medical device manufacturing companies, physicians, hospitals, clinical practices, nursing homes, laboratories, and others. The seminar materials thoroughly cover the statues, safe-harbors, and regulations that govern the health care industry. We will also discuss risk mitigation strategies and compliance program best practices across industry sectors to provide insight into the impact enforcement has on (1) clinical decision-making, (2) costs to providers, payers, and patients, (3) patient safety, and (4) quality of care. In an effort to maintain a broad perspective with the diverse and frequently changing legal landscape in the area, in addition to the case book, materials discussed and presented in this course draw from news reports, trade publications, and U.S. government agency materials.

The class requires a paper of approximately 18-20 pages in length.

This course is Georgetown Law’s introduction to the law and policy of health care provision and financing. No single course can serve as a comprehensive introduction, and this class won’t try. Rather, we’ll consider central themes and selected topics, with an eye toward the larger questions that drive legal, political, and ethical conflict in the health sphere. We’ll begin with some context – the non-medical determinants of health, which have much greater influence on population-wide health than does clinical care. We’ll then turn to the idea of a right to health care, then to the roles of markets and government in making care available and containing medical costs. Next up will be an introduction to the Affordable Care Act, with an eye toward its conceptual framework, its critics’ core objections, and the main problems that it has left unresolved. We’ll examine some of the legal conflicts that have arisen over the ACA, then turn to brief introductions to several other areas of health care law, including medical malpractice, antitrust, and the role of for-profit v. non-profit institutions. We’ll finish with consideration of racial disparities in health care and tension between medicine’s clinical and social roles.

COVID-19 has put a spotlight on our medical care system’s shortcomings, as well as the social inequities that shape Americans’ health and well-being. Our nation’s response to COVID will thus play a substantial role in this year’s edition of the course – as both a matter of national urgency and a window onto these shortcomings.

This course will explore the primary legal and policy principles surrounding the use and disclosure of personal data across the healthcare industry – the key privacy and security laws, regulations and principles that govern how the healthcare industry operates. We also will focus on the concepts surrounding the privacy of health information, and evaluate why this information should be treated differently than other personal information (if at all). We will learn through understanding the relevant legislative and regulatory provisions, and by applying a series of case/situation examples for class discussion. The overall goal of the course is to provide both an understanding of the relevant legal principles for health care privacy in general and to develop an ability to address how these issues arise in legal practice.  

This course will emphasize the primary privacy and information security principles set out in the Health Insurance Portability and Accountability Act (“HIPAA”) as a baseline framework for compliance, and will explore how these rules apply in theory and in practice. We will discuss the best approaches for overall HIPAA compliance. We also will explore emerging areas for privacy and information security, including new enforcement principles, issues related to security breaches and breach notification, and the emergence of “non-HIPAA” data as a new challenge to the privacy and data security regulatory structure (including important developments connected to the Dobbs decision and the COVID-19 pandemic). We will spend some time on issues related to privacy and medical research. We also will assess how these issues affect the business of healthcare, including a broad range of strategic and compliance issues affecting healthcare companies and others that use personal data. We will conclude with an analysis of these issues going forward – how the law and the health care system are changing and how the regulation of the privacy of personal health data can impact these developments.

This course will examine the social, legal, and economic systems in the United States that have precipitated health inequities for different populations throughout history. Students will develop an intense understanding of U.S. public health law and policy constructs and the varied social determinants of health that affect public health outcomes by exploring how past and current U.S. law and policy perpetuate disparities. This course will also explore how legal and policy reform can be utilized to promote health equity and eliminate injustices across populations. Topics covered in the course include health disparities in the U.S. among LGBTQ, immigrant, rural, and minority populations; substance use policy; maternal and child health; and environmental health. The course will utilize various learning modalities such as research review, discussion, case studies, and guest lecturers. By the conclusion of the semester, students will be equipped with tools to leverage the law to improve health outcomes and the skills necessary to become successful practitioners working at the intersection of public health administration and law.

Health care decision-making and innovation are increasingly driven and made possibly by vast stores of data. The importance of data has created an inevitable push-pull dynamic between concerns for confidentiality and demands for medical progress and cost containment. Data is both a privacy risk and a tremendous asset. This course will explore the legal and ethical issues at the intersection of health information, including where data comes from, how it is and should be protected, how it can be used, and risks to its integrity and security. In doing so, this course will cover a range of topics including health information privacy, future use of data assets, and conflicts of interest.

Beyond health insurance and the delivery of health care, goods and services related to individual and public health are highly regulated in the United States, and often serve as a basis for international regulations. These goods and services are a large and growing part of the U.S. and world economy, with some estimates being that more than one-quarter of U.S. food and medical products are regulated by the FDA alone. This regulation is carried out directly by a variety of State and Federal agencies (such as the FDA, the CDC, and the NIH) as well as indirectly through the purchasing power of federally financed programs, such as Medicare.

This course will include an introduction to the basic legal and regulatory frameworks within public health and an overview of the Constitutional limits and policy choices that have led to current law. The course will then move to a review of several major fields of regulation. From a high-level, this includes the regulation of health professionals, health systems, and medical or food products impacting human health. The course will then conclude with an examination of several contemporary problems, such as the safe and effective use of human drug products, infectious-disease prevention and control, ethical research practices, and rationing and allocation of limited resources.

The primary objective of the course is to teach students about the regulation of public health at the intersection of state and federal levels, recognizing that such regulatory frameworks often become the template for international policies. Students will be called on to learn the basics of two fundamental statutes—the Public Health Service Act (PHSA) and the Food, Drug and Cosmetic Act (FDCA). Students will also be called upon to follow examples of administrative change under these statutes, each year analyzing a new set of proposed regulations and sub-regulatory guidance documents. By the end of the course, students will be able to describe the major means by which goods and services used in both personal and public health are controlled, as well as areas in which future changes are likely.

Currently, there is no text or case book on this subject. The primary readings will be assigned by the professor.

The Muslim view is that the origins of Islamic legal code are rooted in the Muslim holy text (the Quran) and Sunna (the portion of Muslim law based on the prophet Mohammed’s words or acts), and it is this jurisprudence that gives Islamic religious practice its connection and sustainability in everything including health law and policy.

This seminar provides an overview of where Islam as a rule of law and global health intersect through subject specific segments. The seminar will start by exploring Islamic law and the history of healthcare under Islamic law and move into segments that discuss food hygiene jurisprudence, prophetic medicine as Sunna, bioethics and Islam, mental health and Islamic law, migrant health and Islamic law, and finally sexual, reproductive and human rights under Islamic law. It presupposes the Quran and Sunna as the legal documents and where relevant, the seminar will discuss comparative aspects to western perspectives.

This seminar supports the notion that global health law is part of a growing health diplomacy where it becomes vital to understand key aspects of how culture and religion can influence health, policy and the law locally and globally.

This course will examine US treaties, court cases, and Congressional acts to explore what it means for the Right to Health to exist, the ways that right is recognized among indigenous peoples, and major shortfalls in achieving equity through these paths. American Indians and Alaska Natives (AIAN) experience serious health disparities in key morbidity/mortality indicators. AIANs are also a bell-weather subgroup in the US for unusual disease such as bubonic plague or the rapid dissemination of novel infectious disease such as happened among tribes in the covid-19 pandemic. In addition to risk and vulnerability that contribute to health disparities, sovereign nation status of the 574 federally recognized tribes in the US and the Indian Health Service that serves them are particular structures shown to mitigate despair and promote future well-being in remarkably difficult circumstances. There are unique laws, operations, and tensions that undergird these structures. Recent actions to strengthen treaty obligations and extend equity movements to indigenous peoples are gathering energy to address health and justice disparities.

This course focuses on the laws and systems foundational to access to care and health services for Indigenous peoples in the US. The course will include discussions on self-determination, sovereignty, funding, social determinants of health, inter-generational trauma and additional elements of Indigenous health law in the US and compare these to other Indigenous health systems particularly those in Canada, Australia and New Zealand.

The course is designed to provide practical skills for students interested in health equity and justice,  Indigenous access to care, Indigenous health law, and policy implementation. The course illuminates, in particular, outcomes of shared American history and distinctive obligations, systems, and opportunities to address ethnic disparities.

This seminar will examine the role of law and policy in addressing modifiable risk factors that contribute to the rising prevalence of non-communicable diseases (NCDs). Risk factors to be addressed include: tobacco use, unhealthy diets, and the harmful use of alcohol. Materials and discussions will probe questions such as: What are the best regulatory practices to deal with NCDs risk factors? How do transnational corporations contribute to the spread of non-communicable diseases? How different international legal regimes come into play in addressing risk factors? What are the opportunities and challenges of using law & policy to address NCDs’ commercial risk factors? Throughout this course we will have opportunities to consider how law and policy shape contemporary legal discussions related to NCDs, such as tobacco plain packaging, alcohol sponsorship, childhood obesity, commercial speech and food labelling, and targeted marketing strategies.

The course will take a global approach grounded in constitutional law and different international legal regimes (WTO, Human Rights Systems "Regional & Universal," among others). The course will explore how the rise in NCDs prevalence in both developed and developing countries is mainly driven by transnational corporations, globalization and foreign direct investment. Additionally, case studies will explore a variety of examples from jurisdictions spanning the United Kingdom, South Africa, and Latin American countries, including taxes to discourage consumption of unhealthy products, laws restricting advertising and promotion, and laws and policies to promote access to information to consumers.

Students will be equipped with an understanding of specific issues, such as the role of law compared with policy, the strengths and weaknesses of different regulatory strategies and the role and responsibilities of the relevant industries in promoting the right to health. After exploring a series of foundational themes and issues through the first half of the course, the remainder will focus on in-depth case studies and experiences in regulating the risk factors from a comparative perspective and future challenges.

This seminar requires attendance and participation in seminar discussions, preparation for class, writing response posts, and the submission of a final paper.

Course goals:

• Understanding of the various risk factors contributing to non-communicable diseases (NCDs).
• Understanding of various models of regulation of NCDs risk factors.
• Understanding of complex risk factors regulatory issues across various constitutional systems and international legal regimes.
• Understanding the interaction between regulation of NCDs risk factors and issues like gender and freedom of speech.
• Understanding the role of transnational corporations in the increased prevalence of NCDs.

This course examines the special legal and policy issues arising from the use of intellectual property rights in the pharmaceutical and biotechnology fields. The course will cover: (1) U.S. case law impacting patents and other intellectual property  in drugs and biologics; (2) the interplay of the regulatory approval process for therapeutic products with intellectual property  rights; (3) the Hatch-Waxman Act and its impact on how patent rights for pharmaceuticals are procured and enforced ; and (4) major legislation  affecting the use of intellectual property  rights in the drug, biotechnology and medical device fields, such as the Biologics Price Competition and Innovation Act of 2009 and the America Invents Act of 2011. Other topics may be included depending on current judicial or legislative developments. A background in biologics or pharmaceuticals is not required, although completion of a basic patent law or a food and drug law course is recommended.

Students will have the option of taking this course for either two or three credits. The three credit option will require a paper that satisfies the upperclass legal writing requirement in compliance with Law Center regulations. The two credit option will require completion of a final paper or of several shorter legal writing samples on student-selected or assigned topics.

The course provides an overview of the international and domestic legal and policy framework applicable to the delivery of foreign assistance and global health for the following: bilateral development partners, international/multilateral institutions, and recipient countries; non-governmental and civil society organizations; and private sector actors.

By the end of this course, students will be able to:

• Identify and interpret the key relevant documents that define whether and how to provide different types of foreign assistance (including foreign assistance statutes and regulations, annual appropriations, bilateral treaties, and international treaties).
• Predict and explain policy decisions based on knowledge of areas of government discretion and restrictions.
• Identify and outline potential options to implement foreign assistance, global health and other projects based on knowledge of cross-cutting, generally applicable rules.
• Identify what you would need to know and the resources an organization will need in order to implement a project in response to a newly identified humanitarian aid or global health crisis or foreign assistance challenge.
• Differentiate between ideals and goals that are achievable under the relevant legal and regulatory framework from activities that are restricted or prohibited.
• Express the values or rationales that most influence or shape your interest in this field and how they inform your ability to assess the likelihood of success of an assistance activity.

The course provides an introduction to the human right to health and its implementation in a few hot topic issues. Issues covered will include criminalization of drug use and sexual and reproductive health, vulnerable groups, HIV/AIDS, the intellectual property regime and access to medicines, and a critique of the current framework and the challenges that impede the realization of the human right.

This course explores the legal, regulatory and policy issues that shape the research, development, and commercialization of drugs, biologics, and medical devices in the United States. We will consider the history and role of federal regulation of medical technologies; legal and ethical issues in the development and testing of new therapies; managing incentives for innovation, including patent, regulatory and data exclusivity; tort liability and its function in the regulation of the life sciences industry; and other issues. We will explore these issues using real-world examples, including the government and industry response to the COVID-19 pandemic.

Everyone wants to live a long and healthy life, but what are the impediments to a longer lifespan, and a longer healthy life expectancy? This course is about legal responses to tobacco use, obesity, poor diet, harmful use of alcohol and sedentary lifestyle – the leading causes of preventable disease in the United States, in high-income countries generally, and increasingly, also in low and middle-income countries.  Cancer, heart disease, stroke, diabetes and tobacco-related diseases (known as “non-communicable diseases” or NCDs) are society’s greatest killers, but what can law do – and what should law be permitted to do – to prevent and control them?

Unlike other global health threats, NCDs and their risk factors are partly the result of consumer choices and transactions lived out every day across the country.  The challenge of creating healthier lifestyles cannot be separated from debates about the regulation of those businesses that have a vested interest in the promotion of harmful products and unhealthy lifestyles. Law’s relationship with tobacco, vaping, alcohol and food is complex and contested. Nevertheless, governments around the world are experimenting with a wide range of legal strategies to encourage healthier lifestyles.  This course places U.S. developments in a global context and offers comparisons with legal strategies for encouraging healthier lifestyles in Australia and other countries.

During the course, we will confront some important over-arching questions.  What are the global determinants of NCDs, and how are these diseases being managed, globally?  What do the global solutions look like?  To what extent should law intervene to influence the behavior of populations – as distinct from leaving lifestyle-related risk factors to the personal responsibility of each individual? Does a regulatory approach to the prevention of NCDs imply coercion? Does it signal the emergence of a “nanny state”? Do legal approaches to reducing NCD risks necessarily depend on motivating people to consciously change their lifestyles, or can laws embody different strategies?  Is it possible to regulate business without micro-managing individuals or “legislating the recipe for tomato ketchup?” Most people want to live longer and healthier lives. This course gives students the conceptual tools to think powerfully about law’s role in the prevention of NCDs, and to participate in debates about effective, appropriate legal interventions.

Course Description

Despite progress in legal protections for LGBTQ+ and non-binary people, and in the face of recent setbacks, LGBTQ+ communities continue to face systemic obstacles to quality health care such as coverage, refusals of care, substandard care, lack of access to culturally competent care, discrimination, and inequitable policies and practices in health care settings. These experiences correlate with significant health disparities, including greater exposure to sexual, institutional, and state violence, higher rates of tobacco and other substance use, mental health concerns, HIV and other infectious diseases, and cancer. These disparities are even more pronounced for LGBTQ+ people who are also members of other groups that face discrimination because of race, ethnicity, or other aspects of identity—such as Black, Indigenous, and other People of Color, young and older people, people with disabilities, people with low incomes, and immigrants, among others.

In this seminar, students will learn about LGBTQ+ health law and policy issues from a variety of perspectives—including medicine, public health, public benefits, health insurance, social determinants of health, and U.S. foreign policy—and gain a better understanding of the legal and social mistreatment of LGBTQ people at both the individual and community level and its impact on health. Topics covered will include health care access, LGBTQ-inclusive data collection, clinical and cultural competency, disability rights, reproductive justice, and health issues facing LGBTQ+ youth and older adults. This course will also examine how LGBTQ+ individuals and families are treated under federal, state, and international law, and how these policies impact access to health care and contribute to health disparities.

Course Goals & Student Learning Outcomes

The primary objective of the course is to teach students about health disparities faced by LGBTQ+ communities, to identify the laws and policies that contribute to these health disparities, identify legal and policy measures to reduce those disparities, and to discuss emerging issues and topics that affect LGBTQ+ peoples’ health. Through this course, students will learn about the impact that federal, state, and international laws and policies have on LGBTQ+ health, including speakers who are actively working in the LGBTQ+ community at nonprofits, Capitol Hill, and government agencies. Past speakers include attorneys from the NAACP Legal Defense and Education Fund, Lambda Legal, National Center for Transgender Equality, the National Immigration Law Center, and the Presidential Advisory Council on HIV/AIDS.

This seminar will help students develop critical thinking skills and will provide a clearer understanding of how federal, state, and international laws and policies impact LGBTQ+ health. The course will also highlight how lawyers can use the tools of law (e.g., litigation, legislation, regulatory action) to advance health justice and equity amid a rapidly changing legal and political environment.

In this interdisciplinary colloquium, leading national and international scholars in a range of domains will explore fundamental normative and policy problems of contemporary concern in health law. Topics will include health care, public health, global health, science, regulation, politics, ethics, and policy. The colloquium will have participants from across the Georgetown University campus among faculty, senior administration, and students, as well as participants in the Washington health policy and legislative community.

Each seminar session will focus on a presentation by, or structured dialogue with, distinguished guest speakers. Students from the Law Center and other schools within Georgetown University (including Nursing and Health Studies, Medicine, Arts and Sciences, Foreign Service, Business, and other graduate programs) will be expected to prepare for intensive discussions in which experts, faculty and students explore, analyze and deepen their understanding of issues selected for consideration each month. The colloquia will be open to other students and faculty members across Georgetown University as well as interested members of the public, particularly professionals working in health law and policy in Washington.

Proper nutrition is one of the many contributor’s to overall health and could be one of the most cost-effective approaches to address many of societal, environmental and economic challenges facing the world today. Increasingly, law and policy has been recognized as a high-impact and robust approach for accelerating progress toward reducing and managing nutrition-related chronic diseases such as obesity, cardiovascular disease, type 2 diabetes mellitus and certain types of cancer. In various jurisdictions, policymakers enact courses of action, regulatory measures, laws and policies, and set funding priorities designed to address food insecurity, hunger, obesity prevention, chronic diseases, among other health and well-being concerns. This course focuses on policies, programs and practices across the globe—at the national, tribal, state and local levels—that improve or hinder healthy eating. Students will examine the evidence informing these courses of action, along with the historical and contemporary legislative, regulatory and judicial aspects. Topics and themes include dietary guidance, food and nutrition assistance programs, food and nutrition labeling, and other environmental and policy strategies to improve access to healthier foods and beverages.

Student Learning Goals:

• Identify key law and policy approaches used across the globe that have been used or have the potential to improve or hinder healthy eating;
• Discuss and debate the historical and contemporary legislative, regulatory and judicial aspects of the key nutrition law and policy approaches during collaborative in-class exercises; and
• Execute analytical and strategic planning for developing, implementing, evaluating, and sustaining a nutrition law and policy approach during in-class exercises and as part of the mid-term and final projects.

In a project-based practicum course, students participate in a weekly seminar and work on a project under the supervision of their professors. This course explores the challenges and opportunities of using law to address risk factors that contribute to the rising prevalence of Non-Communicable Diseases (NCDs), such as unhealthy diets, tobacco use, and alcohol consumption. By taking an international and comparative approach, it navigates the theory behind the regulation of risk factors to NCDs in relation to concrete examples from around the world, with a particular emphasis on Latin America, where considerable progress has happened in recent years. Students will participate in a two-hour/week seminar and carry out 10 hours/week of project work under the direction of the course professors.

SEMINAR: In every class, students will learn substantive content and develop lawyering skills, leading to a comprehensive understanding of the role of law in relation to risk factors to NCDs, including in policy, advocacy, and litigation. Specifically, students will be introduced to NCDs (definition, risk factors, and global burden); understand the role of corporations as drivers of NCDs; learn about regulations to address NCDs, such as pricing and taxation, labelling and packaging, and restrictions to marketing and advertising; and explore the strengths and weaknesses of regulatory, advocacy, and litigation approaches to NCDs. In navigating these topics, students will develop a set of lawyering skills, including generating and using evidence, monitoring policy, building coalitions, conducting scenario-planning, engaging decision-makers, segmenting audiences, and framing arguments.

PROJECT WORK: On the experiential/field-work side, students will work with external partners of the O’Neill Institute for National and Global Health Law (and the newly created Global Center for Legal Innovation Food Environments) on legal and policy projects related to NCDs and the law. For example, students may draft alternative reports to UN bodies analyzing compliance with human rights obligations related to unhealthy diets, tobacco use, or alcohol consumption (e.g., “shadow reports”). Such a report could analyze the prevailing legal frameworks in a particular country and highlight strengths and weaknesses in the statutory and regulatory language. By working with the O’Neill Institute and civil society organizations, the course gives students the opportunity to use law to address critical health challenges.

This course will focus on the legal, public health and medical challenges presented by ongoing pandemics and epidemics, most notably COVID-19, as well as preparedness for future pandemics through the lens of the “One Health” paradigm—an integrated 3-part framework that takes into account the health of humans, animals, and the environment.

The course will address the legal response to epidemic disease, focusing particularly on the World Health Organization's International Health Regulations (IHR), including the process for deciding whether to declare a Public Health Emergency of International Concern (PHEIC) (including historical examples of COVID-19, Ebola, Zika, MERS, Yellow Fever, polio, pandemic influenza, and more). It will also look at other legal mechanisms for pandemic preparedness, such as the Pandemic Influenza Preparedness Framework and examine reforms to global governance for health emergency preparedness that have been proposed as a result of the COVID-19 pandemic.

Prof. Lucey will provide his personal perspective based on on-the-ground work in responding to Ebola, COVID-19, Zika, MERS, SARS Flu, Plague, and more. This work overseas led to his proposal in 2014 to create an Exhibition on Global Epidemics at the Smithsonian Museum of National History, which opened in 2018 and has been extended to 2022 to add COVID-19. The class will include a tour of this exhibit.

The course will be discussion-focused, including readings, videos, interactive lectures, and classroom outbreak simulation ("tabletop") exercises. During these exercises students will be given a fact pattern and assigned a role (e.g., the WHO Director-General, US Centers for Diseases Control and Prevention (CDC) officials, NGOs, etc.) and asked to negotiate with others and reach agreement.

This course will cover the pressing threats to global health security, challenges in pandemic preparedness and response, and the law and policy responses required to make us all safer. We will examine the major actors, institutions, and legal frameworks in global health security, question whether they are adequate to meet the task, and discuss how they can be improved to better prepare the world for future health threats. Specifically, this course will offer opportunities to reflect upon the COVID-19 pandemic, including the weaknesses in international systems that allowed an outbreak to spiral into a pandemic, the various mechanisms utilized in the response, the inequities exposed and exacerbated, and the path forward.

The class will examine legal instruments (both “hard” and “soft” law) at both the national and global level, as well as agencies, institutions, and public/private partnerships.   

The class format will include a mix of formal lectures, class discussions, and real-life simulations as an experiential component. The course is open to both Georgetown JD and LLM students. Subject to changing public health guidance, the course will be taught in person. Attendance and participation will be recorded.

Learning Objectives:

The goal of this course is to guide students to understand and critically assess national and global health law and governance frameworks, together with tools needed to safeguard health security. In addition to law and governance, the class will use health equity as a lens to understand allocation of scarce resources at the national and global level. Additionally, our aim is for students to actively consider solutions to secure a better future; one in which the world can respond to pandemic threats with science and equity at the forefront. We also expect students to develop high quality research and writing skills, presenting a clear thesis and well-developed arguments in all written assessments.

Reading assignments will include chapters and excerpts from the required course text, which explores the threats to global health security, the legal frameworks, institutions, and actors tasked with responding to these threats, and offers a blueprint for a more secure world. The course textbook will be supplemented with up-to-date readings on the COVID-19 pandemic and beyond. Students should come to each class highly prepared to comment and ask questions.

The objective of this 1-credit course is to introduce students to the relationship between international laws governing foreign investment and efforts to protect and promote human health.  The course will examine the extent to which bilateral investment treaties (BITs) and investment chapters in trade agreements that allow for investor-State dispute settlement limit domestic regulatory autonomy, particularly in the field of public health.

International investment law is composed of over 3000 BITs, which govern the acceptance and treatment of foreign investment.  BITs impose various rules that can limit the freedom of domestic policy-makers, including rules governing national treatment, most-favored-nation treatment (principles of non-discrimination), fair and equitable treatment, and expropriation. Foreign investors, including transnational corporations, are increasingly using these rules to challenge domestic regulations such as public health measures through investor-State arbitrations.

The course will address:

1. the theoretical perspectives underlying the international law on foreign investment;
2. the different types of legal tests used to determine the regulatory legitimacy of a measure as well as the impact of varying standards of proof on analysis of this type;
3. rules governing the expropriation of property rights and the circumstances in which health measures might be considered equivalent to expropriation;
4. rules governing the concept of fair and equitable treatment as used in determining the legitimacy of domestic regulatory measures;
5. rules governing non-discrimination and their potential impact on domestic health measures; and procedural issues relating to the participation of civil society in the negotiation of investment treaties and the settlement of investment disputes through international arbitration.

The course is ideal for students in the Global Health Law LLM program or for students wanting a course on international arbitration or international investment law.

Increasing globalization compounds the complexity in preparing for and responding to public health emergencies. Identifying the numerous stakeholders, legal and policy considerations, and authorities in the midst of responding to a potential or declared public health emergency is a difficult endeavor. Fragmented or siloed preparedness activities and efforts before the public health emergency or after the response to the emergency or event inevitably result in duplicative or even confounding efforts, initiatives, authorities, or mandates. In spite of this, governments, international organizations, and non-government organizations continue to combat waning prioritization and urgency to initiate, maintain, and enable preparedness and response activities, capabilities, and functionality. Now more than ever, coordinated integration and implementation of national and international law and policy is critical to ensuring and enabling effective operationalization of stakeholders and resources globally during a response as lives hang in the balance.

Through the analysis of case studies from various global events (including infectious diseases, chemical and radiological events, and natural disasters), this course aims to establish a better understanding of the various global and national legal and policy fora, considerations, and influences and how they have (or have not) been applied in preparedness and response various efforts.

This course will focus on four core issues: quarantine and criminal penalties, access to affordable medicines and intellectual property, the international and constitutional right to health, and how political institutions and race intersect and condition the effect of law on population health. By looking at these issues in both the United States and abroad, particularly in low- and middle-income countries, students will gain a comparative perspective about how law works in practice.

Utilizing HIV and tuberculosis as core case studies, students will explore how law and policy tools can have a significant impact on population health. Today, state actors continue to use law to address public health issues—with examples of both great successes and significant failures.

As public health law embodies both thorny ethical issues and empirical questions about the power of the state to affect health, examining the intersection of law and social science will reveal substantive issues in key health policy issues as well as the conditions under which law and legal advocacy affects wellbeing. HIV and TB, the world’s biggest infectious killers, provide a lens through which to better understand central issues in public health law and policy, which will then be linked to other health concerns in infectious, non-communicable, and environmental health.

This one-week class will be a blend of lectures, discussion, and small group work. Readings will include case law and legal theory as well as texts from political science, economics, and public health. At the end, students will have a better understanding of how and when the law matters for health—which will be of particular interest to students interested in litigation, lawmaking, and public health regulation.

This course explores the interwoven dynamics of law, ethics, and science in public health through examination of core legal theory and practice-based examples. With COVID-19 ushering law, policy, and decision-making around public health into broad public awareness, this class will draw upon current issues in society, enabling students to apply legal and ethical concepts to real-world scenarios. By spotlighting recent and historical examples of public health law in action, including COVID-19, opioids, obesity, tobacco, and the environment, this course will be valuable for students interested in health law and equity, as well as students seeking to deepen their expertise in public policy.

Students will learn the conceptual foundations of public health law in the United States, with particular attention to the statutory and regulatory powers and duties of federal and state governmental entities to protect the health and safety of the population and the judicial decisions that shape them. Sources of tension between public health goals and objectives and civil liberties will be interactively contemplated, including, among others: disease surveillance and privacy; labeling and advertising restrictions and free speech; and considerations around individual versus population-based conceptions of health. Discussions of recent major legislative developments and court decisions impacting jurisprudence, public health authority, and individual rights will be incorporated alongside primary themes. Throughout the course, students will engage with public health law through applied learning—case studies and class exercises—focused on analyzing emerging issues, comparing national and global responses, understanding ethical implications, and developing legal and policy strategies that integrate health equity and address social determinants of health. 

Public-Private Partnerships (PPPs) are a modern means for pursuing social and policy outcomes. When they work, they mobilize the comparative advantages of the public and private spheres to address key challenges. When they fail, critics cite their worst aspects and argue for a retreat into more traditional roles. Their prevalence means that everyone is likely to come across, and be affected by, such a partnership at some point in their careers.

Serving as a lawyer to a PPP provides an exceptional challenge because the tools and strategies that work when counseling in the public sector may be strange or ill fit for purpose in the private sector (and vice versa). Effective PPP lawyers are translators and guides: they ‘speak both languages’ thus positioning themselves to propose innovative, non-obvious solutions and can build trust with, and among, partners and stakeholders.

Bridging theory and practice, students will have the opportunity to understand why PPPs have emerged and how they operate. They will also receive practical tools and knowledge to allow them to work with or within a PPP and discuss and debate sophisticatedly how they should be managed and governed.

To do this, the course uses a mix of lecture, discussion, video, and experiential learning. A key feature is a simulation that provides students the opportunity to experience the formation of a PPP using the tools they develop during the semester.

Access to affordable and quality health care continues to elude millions of Americans despite progress over the last several decades. While millions of Americans gained coverage through the Patient Protection and Affordable Care Act (ACA), implementation of the law’s reforms have been challenging, and its provisions have been subject to extensive litigation and continued threats of repeal. The legal and policy clashes over the ACA’s implementation have foreshadowed future obstacles facing subsequent major health care reform initiatives – such as the No Surprises Act and Medicare Drug Price Negotiation Program – and fundamentally altered the role litigation plays in shaping health care policy. This will likely have major implications as policymakers look to address the major problem of high and rising health care costs for the privately-insured through efforts to lower health care prices – the main driver of rising costs.

This course will examine the regulation of private health insurance and health care prices in commercial insurance and public programs. The course will explore federal regulatory changes under the ACA; subsequent reforms to private insurance under the No Surprises Act and other measures under consideration to address health care pricing; the new authority for Medicare to negotiate the price of prescription drugs; and legal challenges burdening the regulation of private health insurance and efforts to regulate health care prices. This course will also examine real-time policy and legal developments following the passage of the “One Big Beautiful Bill” Act (OBBBA) in 2025 and its implications for health care affordability, quality, and accessibility, as well as the expiration of COVID-era subsidies for certain individuals receiving insurance through the ACA. Guest lectures will provide students with a greater, contextualized understanding of former and current legal and policy disputes related to private health insurance regulation and measures to address rising health care prices. The course will also explore what these legal and policy efforts mean for consumers,  public health, and broad work to address inequities in health care access and outcomes—as well as where policymakers may push forward with health reform in the future.

This fieldwork practicum course, focusing on the interaction between international human rights law and reproductive health and rights.  The course will provide an overview of international reproductive health and rights, while affording students an opportunity to work in organizations that are addressing issues in the field in various ways.

As such, students participate in a two-hour weekly seminar and work for 10 hours/week for at least 11 weeks during the semester at an outside organization.

SEMINAR: The seminar will begin by providing an overview of international human rights law as it pertains to reproductive rights. The course will then focus on access to reproductive and sexual health from an international perspective, examining States’ obligations on a variety of issues, such as maternal mortality and coerced sterilization. Analyzing recent decisions emerging from regional and international human rights bodies, such as the European Court of Human Rights, the Inter-American Commission and Court on Human Rights and the CEDAW Committee (UN Committee on the Convention on the Elimination of All Forms of Discrimination against Women), the seminar component will provide a necessary foundation for the students to conduct their fieldwork.

Fieldwork: Students will be placed with organizations working in the area of reproductive rights. Most likely, the work will be conducted remotely, as several of these organizations are not based in the Washington D.C. area. The work conducted for this portion of the course will be supervised by the external organization

Some of the projects may include assisting in drafting amicus briefs for cases currently pending before international bodies, and briefs assessing a particular State's compliance with human rights law regarding sexual and reproductive rights to be filed in front of UN bodies (shadow reports). Through these projects, students will learn how to conduct an analysis of existing legal and regulatory frameworks for sexual and reproductive health from a human rights perspective. By working with external civil society organizations, the course will give students the opportunity to develop practical projects using international human rights law to advocate for the advancement of reproductive health rights. In the past, external partners have included organizations working on women's rights issues, such as: the O'Neill Institute for National and Global Health Law, the Center for Reproductive Rights, Women’s Link Worldwide, Human Rights Watch (Women’s Rights Division), IPAS, the Women's Equality Center, and the Southern Africa Litigation Centre, among others.

Reproductive Justice is a concept developed by Black Women activists in the 1990s to provide a different framework to explore how systemic oppression impacts reproductive decision-making. Acknowledging that abortion and contraception were often not the primary reproductive concerns of many marginalized women, including women of color, young women, women with disabilities, undocumented women, and queer women, activists adopted a framework that considers the contexts in which reproductive decisions are made. This approach centers social, racial and economic justice, and focuses as much on the rights to have and raise children as it does on the right to not have them though access to safe and legal abortion care and contraceptive access.

This course will focus on the rights to not have a child, to have a child, and to raise a child. The course will not focus on abortion or contraception, but will address the impact of Dobbs and forced birth. Students are welcome to focus their writing requirement on abortion or contraception. The course will take an interdisciplinary approach to the issues, incorporating various bodies of law (family law, welfare policy, criminal law) along with an historical analysis, social science, and current events.

This course will explore the history and law of reproductive rights in the United States.  The majority of the semester will be spent analyzing the constitutional framework, jurisprudence and federal and state regulations governing forced sterilization, contraception and abortion from the 1920s until today.  We will consider the historical, social and religious context of the regulation of reproduction; gender, race and socioeconomic class issues; and the practical impact of the regulations in effect today. This course is primarily focused on reproductive rights in the United States, but we may consider comparative international perspectives.

Please note that this course will not cover regulation of parenting, adoption, foster care, assisted reproductive technologies or related reproductive health topics, or reproductive justice in any meaningful detail.

All students are expected to read the assignments, attend class, and prepare for active discussion every week. Depending on course enrollment, I may assign small groups of students to assist me in leading each week’s discussion of the assigned materials.  Short oral presentations on current events or topics of particular interest will likely be assigned during the second half of the semester.

Grading: Class participation, including oral presentations, and/or short reaction papers will represent at least 35% of the final grade.  A take-home exam will account for the remaining 65%.

The class will focus on reproductive health and the law.  Understanding and learning about the legislative process is essential to this class. Reproductive justice issues span not only constitutional law considerations, but also other aspects of law, society, and the political process.   Topics researched and/or discussed will include abortion, assisted reproduction, contraception, treatment of incarcerated pregnant individuals, pregnancy exclusion laws, rape and statutory rape laws, personhood and feticide laws, surrogacy, the use of child endangerment laws to prosecute women for their conduct during pregnant, and parenthood.

Students will learn how to perform in-depth research and analysis involving these subjects and will then learn the process of drafting legislation, understanding the legislative process, and productively working with legislators, policy makers, advocacy groups, and other interested parties to promote reproductive liberties and enact necessary changes.

All students will gain significant exposure to legal research and writing and will work closely with the instructors to develop and hone these critical skills. 

Course Goals:

The goals of this course:

• Introduce students to the study of reproductive health law, policy, and regulations
• Familiarize students with the social, medical and legal literature on the topic
• Engage students with practical as well as theoretical ideas in reproductive justice

• Stimulate intellectual curiosity about the subject matter
• Inspire thoughtful analysis
• Encourage and facilitate discussions

This course provides an opportunity to explore issues related to the use of humans as research subjects. The course will begin by examining the history of human subject research, including the abuses that led to the creation of our modern legal protections. Following a discussion of the ethical principles of research involving humans, we will carefully explore the legal treatment of human subjects, focusing on US regulations and international instruments. Core sources will include: the Common Rule (45 CFR 46), Belmont Report, Declaration of Helsinki, Nuremberg Code, and CIOMS. After exploring a series of foundational themes and issues through the first half of the week, the remainder of the class will focus on in-depth case studies. Topics may include: international research, research involving vulnerable populations (children, prisoners, and pregnant women), informed consent, research on subjects with impaired decision-making abilities, genetic/genomic research, risk-benefit analysis, coercion/undue inducement, use of placebos, and IRB governance.

This course provides a general overview of the federal labor and tax law policies and principles that apply to employment-based retirement plans, health care plans, and executive compensation arrangements. Students will examine the principles of the Internal Revenue Code and ERISA that govern the form and operation of employer-sponsored plans, especially tax-qualified pension plans, executive compensation arrangements and welfare plans (with a focus on health care). This class will concentrate on the structure and basic rules that govern such arrangements. In the context of tax-qualified and nonqualified plans and health and welfare programs, this course will explore plan administration, fiduciary duties, claims appeals and litigation.

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[1] Although we will typically use the term “woman” to refer to a person who gets pregnant, and mother as a person who gives birth, we honor and recognize that not all people who become pregnant identify as women.

Developments in neuroscience and the psychological study of cognition and emotion are transforming our understanding of the mind. These developments have large implications for law and lawyering. They challenge some of civil and criminal law's central premises - about people's rationality, free choice, and consistency over time. This course will examine some of these challenges, and it will weigh the law’s possible responses. Legal topics to be explored will include health and safety regulation, the idea of the reasonable person, intent and culpability, mental disability, and the roles of revenge, regret, and other motives in civil and criminal justice. Other themes, relevant to lawyering and to the management of conflict, will include the psychology of negotiation, the nature of intuition and judgment, and the roles of trust and social norms. The course will also consider the causes and control of violence and extremism, as well as the use of emerging neuroscience technologies for legal and national security purposes.

The Doctors Trial considered the fate of twenty-three German physicians who either participated in the Nazi program to euthanize persons deemed "unworthy of life" (the mentally ill, mentally retarded, or physically disabled) or who conducted experiments on concentration camp prisoners without consent. The Doctors Trial lasted 140 days. Eighty-five witnesses testified and almost 1,500 documents were introduced. Sixteen of the doctors charged were found guilty. Seven were executed.

The Doctors Trial provides a significant and important example of human rights violations and serves as a lesson in law and bioethics vital to understanding how law evolved from an initial eugenics policy to and including the horrible examples that framed human atrocities during WW II. 

This course will highlight examples from Jeanne Guillemin's "Hidden Atrocites, Japanese Germ Warfare and American Obstruction of Justice at the Tokyo Trial", Joel Dimsdale's  "Anatomy of Malice" examining the psychological assessments necessary for the trials, and Vivien Spitz's "Doctors from Hell", delving deep into the actual court transcripts from the proceedings. Ben Ferenz's work, one of the actual prosecutors at the trials, will also be included as insight into this tragic period. 

WHO is the sole global health organization and, as such, has been traditionally considered the lead actor in this domain at the center and the forefront of technical, policy and normative developments in global health governance.  Its Constitution and institutional structure represent both the embodiment of a new way of thinking about global health and its governance at the time of creation of the UN system as well as the outcome of political compromises that have affected the life of the organization and its positioning in the global health landscape.  The historical development of WHO’s functions and activities are also an emblematic reflection of the changing role of health in the global economic, political and development agendas and, as such, can shed light on broader issue of international law and relations.  WHO’s role and significance as the central actor in global health governance  has been the object of contestation and much critical reflection starting in the 1990s and culminating with the organization’s role in responding to recent health emergencies such as the 2014-2015 Ebola outbreak in West Africa and most importantly the COVID-19 pandemic.  At the same time, global health governance has become more complex, fragmented and politicized and the future role of WHO has to be seen in the context of those developments and the search for a coherent global health architecture.

The course will focus on four broad areas covering the most important aspects of WHO as an international organization, an actor in global health governance, and a forum for policy and legal developments: 1) Historical, constitutional and institutional aspects; 2) normative functions, with particular focus on the International Health Regulations, and the role of WHO in the development of international law; 3) directing and coordinating functions, both in terms of how to address the most important health challenges as well as with regard to WHO’s interaction with a number of political and economic regimes; 4) the position of WHO in the current global health landscape, both with regard to the role of other actors as well as to how the organization should look to its own future.

The course will allow students to gain not only an in-depth knowledge and appreciation of WHO from an institutional and structural perspective, but also most importantly to appreciate the main contemporary challenges in global health as well as the role of health in a number of critical policy and normative regimes.  The approach of the course will be based on lecturing, class discussions and at least one class exercise.  Prof. Burci’s former tenure as the Legal Counsel of WHO and a long-term senior lawyer in the organization will allow him to contribute real-life examples and experiences that will better root the course in the realities of the life of an international organization

In a fieldwork practicum course, students participate in a weekly seminar and conduct related fieldwork at an outside organization focused on toxic chemical law. For example, have you ever wondered what is in the food and drink we consume besides the raw agricultural products such as coffee beans or milk? In this course, students will explore the how the Food and Drug Administration (FDA) under the Food, Drug, and Cosmetic Act, by the Environmental Protection Agency (EPA) under the Toxic Substances Control Act and other statutes, and the the Consumer Product Safety Commission (CPSC) under the Consumer Product Safety Act work together (or don’t) to regulate toxic chemical products in consumer products that are consumed or used in the U.S. every day such as coffee, soft drinks and yogurt. Students will develop real-world lawyering skills such as fact gathering, legal research, drafting, developing guidance or advice, crafting advocacy strategy and more. Students will participate in a two hour/week seminar and also undertake 10 hours/week of fieldwork at the Environmental Working Group (EWG), a public-interest nonprofit that advocates on behalf of consumers, and other non-governmental organizations.

SEMINAR: The authority of the FDA, EPA and CPSC to regulate the safety of toxic chemicals in consumer products has evolved as the manufacturing of everyday products has become increasingly industrialized and affected by an array of new technologies that cause the food and drink we regularly consume to contain potentially harmful chemicals. This seminar will utilize legislative and administrative materials as well as case law to enable students to critically evaluate the processes by which the federal government regulates toxic chemicals in consumer products and compare and contrast regulatory schemes for different consumer products. The course will also touch on related topics such as the role of the Federal Trade Commission in the regulation of marketing trade practices related to chemicals in consumer products.

FIELDWORK: In the fieldwork component of this course, students will be assigned to projects at the Environmental Working Group or a similar non-governmental organization. They will have an opportunity to learn how such institutions play a role in representing consumer interests in product safety issues being debated in both the administrative and legislative processes, and in matters subject to litigation.

U.S. Health Law and Diplomacy in a Global Context aims to introduce U.S. health law and policy through comparative and international lenses. The course will provide interested students with a broad introduction to key areas of domestic health law (health coverage, public health, product regulation, social determinants outside the health sector), including divisions of responsibility at the federal, state, and local levels in the unique health policy environment of the United States. The course will also provide a basic comparative framework for understanding the U.S. health law and policy systems within the broader experience of high-income countries and other health systems. Moreover, this course will explore the role that the U.S. plays in shaping and engaging in global health law through international law, federal assistance programs, and participation in international organizations. This element of the course will focus on the Constitutional and legal context for U.S. foreign policy relating to health, including critical issues relating to the U.S. role in the World Health Organization. Throughout the course, special attention will be paid to way in which law impacts health, more broadly the notion of “legal determinants of health” as articulated in the final report from the Lancet-O'Neill Institute/Georgetown Commission on Global Health and Law.