HealthLawProf Blog

Strengthening Policies and Structures to Combat Illicit Tobacco Trade in the Philippines

John Rafael Arda (Ateneo School of Government), Alen Josef Santiago (Ateneo School of Government), Strengthening Policies and Structures to Combat Illicit Tobacco Trade in the Philippines (2023):

The Philippines has been seeing an increase in illicit tobacco trade in recent years, undermining the impacts of legal measures such as tobacco products’ taxation and regulation due to circumvention of established avenues and costing the government its revenue. Currently, the country has twelve policies related to the prevention of illicit tobacco trade with gaps identified in its lack of licensing systems for tobacco retailers and policies on law enforcement cooperation, which manifests in the country being fully compliant to only 5 of the 16 articles under the World Health Organization's Illicit Tobacco Trade Protocol. It is recommended that the country establish a national agency or framework specifically for illicit tobacco trade to address its gaps under Tracking and Tracing, Due Diligence, and Unlawful Conduct.

COVID-19 Surveillance in India: A Bridge Too Far

Vrinda Bhandari (Independent), COVID-19 Surveillance in India: A Bridge Too Far, in Private and Controversial: When Public Health and Privacy Meet in India (Parsheera ed., Harper Collins, New Delhi) (2022):

This chapter evaluates the surveillance measures undertaken by the Central Govt. and various state governments in India during the Covid-19 pandemic. It presents a comprehensive mapping of the different types of physical and digital surveillance measures adopted by the state and by certain private actors to deal with the COVID situation. The chapter classifies these measures based on the underlying functions of symptom tracking, mobility and density mapping, quarantine enforcement, contact tracing, travel passes, and vaccination. Similar to the experience globally, India’s response to the pandemic has largely been a tech-centric one. But this has been done without a legal framework on data protection or sufficient focus on the utility, reliability, accuracy and security of many of the interventions. India’s legal response to the pandemic has hinged on its classification as a disaster, although the ‘long tail’ of the pandemic makes it very different from other types of disasters that are often of a finite and limited duration. The use of extraordinary technological measures to deal with the crises, therefore, comes with the fear of certain types of surveillance being normalized in the long run.

Systematizing Safety: The Urgent Need for Integrated Safety Management Systems in Healthcare

Carl Macrae (University of Nottingham), Systematizing Safety: The Urgent Need for Integrated Safety Management Systems in Healthcare (2022):

Patient safety remains a difficult and persistent challenge for healthcare organizations around the world. Despite enormous effort and considerable investment over the past several decades, frustrations are rising at the limited progress that has been made. One of the most striking features of the past few decades of effort to improve patient safety is the isolated and individuated character of much of this work: the field has blossomed with separate interventions, stand-alone programmes, discrete processes, individual roles, and distinct policies. This blooming of a thousand flowers across the field is indicative of the creativity and experimentalism that has been brought to bear on the problem of patient safety. But it is also indicative of something much more troublesome: fragmentation and—in its most literal sense—disintegration characterise many approaches to patient safety, both within individual healthcare organizations and across entire healthcare systems. What has long been missing—and what healthcare organizations and regulators urgently need to develop—are carefully structured and reliably implemented safety management systems in which all safety-relevant functions, activities, priorities and accountabilities are tightly integrated, properly resourced and coherently organized so that every potential source of harm and risk (and all sources of safety and resilience) can be proactively managed in each care setting across a healthcare system. This paper explores the challenge of what integrated systems of safety management should look like in healthcare and how we should get there. Three areas help point the way: other safety-critical sectors that have travelled this path before; emerging thinking and exploration in healthcare organisations; and the policy and legislative context that frames this journey. Each is considered in turn.

Innovate Food Law Workshops’ Proposals Workshop 1: Deliberative Mini-Publics for Benefits’ Assessment of Gene Edited Products Workshop 2: Making the Novel Food Regulation More Innovation-Friendly

Alexandra Molitorisová (University of Bayreuth), Alessandro Monaco (University of Bayreuth), Kai Purnhagen (University of Bayreuth), Innovate Food Law Workshops’ Proposals Workshop 1: Deliberative Mini-Publics for Benefits’ Assessment of Gene Edited Products Workshop 2: Making the Novel Food Regulation More Innovation-Friendly (2023):

This document contains a detailed methodology for 2 workshops to be held at the mid-term Innovate Food Law project meeting (http://innovatefoodlaw.eu) and will be open for observations by invited project partners and other interested parties. The 2 workshops consist of Workshop 1: Deliberative Mini-Publics for Benefits’ Assessment of Gene Edited Products and Workshop 2: Making the Novel Food Regulation More Innovation-Friendly. Workshop 1 and Workshop 2 will be running in parallel.

Sociotechnical Sources of Risk and Resilience in Autonomous and Intelligent Systems: Exploring Safety in the Implementation of Clinical Artificial Intelligence

Carl Macrae (University of Nottingham), Sociotechnical Sources of Risk and Resilience in Autonomous and Intelligent Systems: Exploring Safety in the Implementation of Clinical Artificial Intelligence (2023):

Autonomous and intelligent systems (AIS) are being developed and deployed across a wide range of sectors and encompass a variety of technologies designed to engage in different forms of independent reasoning and self-directed behaviour. AIS may bring considerable benefits to society but implementing these technologies poses a range of risk management challenges, particularly in safety-critical sectors where complex interactions between human, social and technical processes underpin safety and resilience. Healthcare is one safety-critical sector that is at the forefront of efforts to implement AIS, primarily through clinical artificial intelligence systems intended to support or replace key aspects of clinical work such as reading medical images to identify signs of pathology and make referral decisions. This paper develops a detailed qualitative analysis of the sociotechnical sources of risk and resilience associated with implementing clinical artificial intelligence in healthcare. The analysis draws on 40 in-depth interviews with participants actively involved in the implementation and regulation of clinical artificial intelligence. Qualitative template analysis is used to examine the sociotechnical sources of risk and resilience in the specific setting of healthcare, drawing on and elaborating Macrae's (2022) SOTEC framework that integrates structural, organisational, technological, epistemic and cultural sources of sociotechnical risk in AIS. This analysis characterises and contextualises the sociotechnical sources of risk associated with implementing AIS in healthcare and identifies an array of sociotechnical patterns of resilience that may counter those risks. Through this analysis, the paper extends the SOTEC framework to encompass new patterns of sociotechnical risk and explores the duality of risk and resilience in the management of safety.

Legal Considerations for Offering Metaverse-Based Education

Jon Garon (Nova Southeastern University), Legal Considerations for Offering Metaverse-Based Education (2023):

Although the metaverse is still in its early stages, those emerging metaverse platforms such as Roblox and Fortnite have over 400 million monthly active users, the majority of which are 13 or younger. A generation of learners and future citizens are emerging from a future that is not evenly distributed or well understood by the parents, educators, and policy makers who provide resources and establish educational policy.

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Legal Ableism: A Systematic Review of State Termination of Parental Rights Laws

Robyn Powell (University of Oklahoma), Legal Ableism: A Systematic Review of State Termination of Parental Rights Laws, Washington U. L. Rev. (Forthcoming):

Although the fundamental right to raise a family is among our m ost cherished, it is not equally afforded to everyone. Indeed, the United States has an appalling and enduring history of policing parenthood among people with disabilities. In recent years, the rights of parents with disabilities and their children have garnered unprecedented attention from activists, scholars, legal professionals, and policymakers. Nevertheless, the number of disabled parents who have their parental rights terminated is substantial and growing. As such, the roots of these ongoing injustices must be investigated. To that end, because the family policing system, including termination of parental rights, is primarily governed by state statutes, such an interrogation must begin there.

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Older Persons and Climate Action

Alan S. Gutterman (Independent), Older Persons and Climate Action (2022):

Despite arguments, and some polling evidence, to the contrary, older adults are just as concerned as younger people about climate change; however, uncertainty remains about the optimal strategies for leveraging the resources that older people can bring to the debate surrounding climate change. One big problem is misconceptions about the physical and mental capabilities of older persons and their ability to contribute to climate action and there have been calls for a reframing of the general aging narrative in US society to emphasize that older adults represent a precious form of human capital with the potential to contribute creatively and constructively solving urgent societal problems, including those associated with climate change. The UN High Commissioner for Human Rights has argued that older persons possess enormous knowledge, experience, skills and resilience that give them the capacity to be key contributors in global efforts to mitigate and adapt to the negative impacts of climate change. The OHCHR emphasized the various ways in which older persons bring unique and important contributions to climate action, including supporting their families and communities financially and through informal care work, contributing to decision-making and conflict resolution, imparting important knowledge of science, history, tradition and culture and wielding significant voting and economic power that can be mobilized for effective climate policy. This chapter explores how older people can be involved in climate action as volunteers, voters, consumers and active participants in setting priorities and policies for addressing climate change.

“Just Do Something,” But Not that: The Structural Harms of Providing Mental Health Services Through the Bipartisan Safer Communities Act

Heather Swadley (Swarthmore College), “Just Do Something,” But Not that: The Structural Harms of Providing Mental Health Services Through the Bipartisan Safer Communities Act, Nebraska L. Rev. (Forthcoming):

Many have proclaimed that the Bipartisan Safer Communities Act is most sweeping gun control legislation to be passed in decades. However, the bill is not primarily a gun control bill—instead, much of the Act seeks to improve mental health services in hopes of preempting gun violence. Such a move is not rooted in established evidence, which finds little predictive value in knowing a someone’s mental health history. In fact, people with mental health disabilities are more likely to be victims of violent crimes than perpetrators. The Act therefore shifts the debate about gun reform from one about easy access to guns to one about improving mental health services. This is not without consequence.

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A Look at the Current Status of the CRISPR Patent Interferences Involving Broad Institute, University of California and University of Vienna, ToolGen, and Sigma-Aldrich

Christopher M. Holman (University of Missouri), A Look at the Current Status of the CRISPR Patent Interferences Involving Broad Institute, University of California and University of Vienna, ToolGen, and Sigma-Aldrich, 41 Biotechnology L. Rep. 169 (2022):

This article reports on recent developments in patent interference proceedings relating to use of CRISPR-Cas9 for gene editing in a eukaryotic environment. The article begins with a brief overview of some substantive and procedural aspects of patent interference law of particular relevance to these proceedings, followed by a summary of the status of the interferences at the time this article was written, based primarily on information gleaned from the declarations of interference and motions filed by the various parties. It concludes with some thoughts on how things might ultimately settle out in the fight to control the patents in this important technological space.

Conjuring the Flag: The Problem of Implied Government Endorsements

Michael Mattioli (Indiana University), Conjuring the Flag: The Problem of Implied Government Endorsements, 83 Maryland L. Rev. (2024):

This Article exposes a prevalent and harmful form of advertising that exploits government actions like patent issuances, FDA authorizations, and trademark registrations. By calling upon the symbolic power of such regulatory approvals—i.e., “conjuring the flag”—marketers deceive consumers, distort competition, and undermine administrative agencies. Using machine-learning techniques to analyze thousands of ads across multiple media formats, this Article offers the first empirical study of this pervasive practice. The study reveals that it is especially prevalent in industry settings where consumers are likely to seek reassurance that a product is safe and effective. Specifically, the data shows that patents are mentioned most frequently in ads for supplements, cleansers, cosmetics, insect sprays, and hair products. It also shows that the USPTO contributes to the problem by registering trademarks that incorporate regulatory references. Consumer protection laws and regulations have failed to curb this practice, as advertisers have found subtle and legally permissible ways to manipulate consumer perception. This Article proposes two legal reforms to empower the FTC to address this issue more effectively. This Article thus sheds light on a crucial intersection of intellectual property, consumer protection, and administrative law.

Evaluating the Carceral Kitchen: A Qualitative-Abductive Approach

Robb Elton (National University), Evaluating the Carceral Kitchen: A Qualitative-Abductive Approach (2022):

The U.S. criminal justice industrial complex (CJIC) consumes goods and services from industries ranging from health care, textiles, wood, metal to many products and proprietary strategies related to security, including specific architectural engineering designs. There are unfortunately millions of prisoners at any given time throughout facilities operated by numerous jurisdictions across the United States. The prisoners must be clothed, have access to health care, and they maintain a number of other rights under the U.S. Constitution. Prisoners must also be fed, thus, the CJIC also demands adequate food services, related staffing levels, including adequately trained and vetted personnel. Related to the CJIC are the policies, procedures, and laws governing limitations and carceral activities which affect logistics. The rationale for these rules must be understood by non-prisoners and potential employees of the CJIC alike, specific to the prison kitchen (carceral kitchen). The purpose of this article is to extrapolate reasons for the disparate absence of managerial, administrative literature from this sector, and perhaps that answer can be found in the ways and manner these environs (carceral kitchens) likely differ from commercial kitchens. The research draws upon author observation and experiences from commercial and carceral kitchens. The findings from this research are hopefully informative for future students/graduates in related fields in that it infers opportunities and skills applicable for applying culinary arts and food service in carceral kitchen systems. The findings suggest that geography/security strategy inhibits access to professional/academic opportunities. Additionally, however this niche can be a place for advancement and opportunity for entry level workers while at the same time demand creativity and managerial prowess/people skills.

The Rise and Fall of the Mental Health Inquiry for Bar Admission

Colin M. Black (Suffolk University), The Rise and Fall of the Mental Health Inquiry for Bar Admission, 50 Capital U. L. Rev. (2022):

For millennia, legal advocates have been expected to have good moral character. There can be no doubt that effective lawyering requires honesty and integrity. Over the years, how character is defined for practitioners has changed. In the 1970’s, the American Bar Association began evaluating bar applicant mental health as part of the good character evaluation. Ostensibly, this was done to protect the public and the administration of justice. In 2017, the American Bar Association recommended the elimination of the mental health questions on the character and fitness portion of the application to the bar. Notwithstanding, many jurisdictions continue to inquire into an applicant’s mental health status as a prerequisite to admission. Recently, however, the growing concern for lawyer well-being has highlighted the criticisms of this prophylactic inquiry. There is little evidence of a causal connection between mental health issues and unethical lawyering. Additionally, meritorious disability discrimination claims have warranted a reexamination of the practice of inquiring about the mental health of bar applicants. To be sure, the American Bar Association, bar authorities, law schools, and local bar organizations have all implemented various programs addressing the symptoms of the profession’s mental health crisis, including changes, and in some cases, the complete elimination of the mental health inquiry of the character and fitness evaluation portion of the bar application. All of these actions lead the author to conclude that the practice of inquiring about a bar applicant’s mental health serves no apt purpose nor predicts the ultimate elimination of the inquiry completely.

The Future of Pandemics: Land Use Controls as Means of Preventing Zoonotic Disease

Bailey Andree (Pace University), The Future of Pandemics: Land Use Controls as Means of Preventing Zoonotic Disease, 35 Pace Int’l L. Rev. 1 (2022):

Zoonotic diseases are increasing in frequency as climate change worsens around the world, with the recent COVID-19 pandemic highlighting the inadequate mechanisms in place to counteract disease spread. This article reviews various zoonotic diseases and their patterns of spread, highlighting land use change as the key driver of disease to demonstrate the need for legal intervention. International land use law is a little-developed subsect of environmental law that holds the key to combating this disease spread, and this article proposes solutions through this legal lens. Land use techniques which may be used to combat disease spread include conservation laws, setback and buffer requirements, increased density in development, variances, environmental impact assessments, land-based financing, and variances, in addition to international treaties.

Corrupt or Charitable? Patient Assistance Programs and the Case for Narrowing the Breadth of the Federal Anti-Kickback Statute

Isaac Strauss (Yeshiva University), Corrupt or Charitable? Patient Assistance Programs and the Case for Narrowing the Breadth of the Federal Anti-Kickback Statute, 44 Cardozo L. Rev. 2 (2022):

This Note surveys how the Federal Anti-Kickback Statute serves to penalize helpful healthcare arrangements in which pharmaceutical companies seek to assist patients with their cost-sharing obligations under Medicare Part D.

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Enough Excuses on Drug Importation a New Transnational Paradigm for FDA Regulation and Lower U.S Drug Prices

Gabriel Levitt (Brooklyn Law School), Enough Excuses on Drug Importation a New Transnational Paradigm for FDA Regulation and Lower U.S Drug Prices, 49 Brooklyn J. Int’l L. 1 (2023):

The U.S. Food and Drug Administration (“FDA”), which enforces drug safety laws, asserts that under most circumstances the importation of prescription drugs is illegal. Yet because of high drug prices in the United States, over the past couple of decades, tens of millions of Americans have imported prescription drugs for personal use. For many, this was their only way to afford them. A unique array of federal laws, regulations, and policies, including the de facto decriminalization of the practice of personal drug importation, have in effect permitted personal drug importation. The same exceptions, however, are not available for commercial drug importation, also called wholesale or parallel importation. While personal drug importation has helped many people afford prescription drugs and could help even more with the correct use of executive authorities and public support, a longer-term solution to high drug prices in the U.S. may require larger, commercial-scale drug importation.

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The Techno-Optimist Case for Addressing Sustainability and its Grounding in Capitalist (Market) Incentives

Daniel R. Cahoy (Pennsylvania State University), The Techno-Optimist Case for Addressing Sustainability and its Grounding in Capitalist (Market) Incentives (2023):

The effort to create a more sustainable society touches on many facets of the environment, public policy and social responsibility. We seek solutions to the negative impacts of climate change, a lack of access to medicines, environmentally friendly sources of energy that will permit continued economic progress, and sufficient food to feed a world of ten billion people. Many say that a conservation-based approach that restores humanity to a more natural state is the best path forward. But to others, the only way out of our predicament is the way we got in: technology. A “techno-optimist” mindset views sustainability issues largely as problems that can be solved through invention and investment. But is techno-optimism a realistic strategy for creating a more sustainable world? This chapter first explores the nature of techno-optimism as a contrast to "eco-pessimism," considering how the former pushes technology-based solutions while the latter focuses on conservation and reduction. The chapter then demonstrates the fundamental connection between technology incentives and capitalism, looking particularly to increasingly harmonized legal systems that have created an ever-broader base for innovation. Finally, it considers evidence that technology-based solutions are more than a distraction or palliative by looking at the contexts of disease, food security, water and energy production.

Equality Emerges As a Ground for Abortion Rights In and After Dobbs

Cary Franklin (University of California, Los Angeles), Reva Siegel (Yale University), Equality Emerges As a Ground for Abortion Rights In and After Dobbs (2023):

Equality as well as liberty arguments can structure the debate about abortion that continues after Dobbs, in litigation and in legislation, in state and federal arenas. We draw on case law, history, and common sense to show that principles of equal citizenship require government to protect potential life in different ways today than it has in the past, when criminal bans on abortion enforced caste-based understandings of women’s roles. While states enforcing gender status roles have long assumed that government can coerce the labor of lifegiving, equal protection commitments give rise to an anti-carceral presumption in regulating abortion. As state laws inside and outside the abortion context attest: States that respect women as equal citizens do not turn, as a matter of first resort, to measures that rely on coercion when there are numerous less discriminatory and less restrictive ways to protect potential life. Reaching for carceral solutions perpetuates the forms of inequality that are the central concern of sex-based equal protection law. To opt for the maximally coercive approach—forced pregnancy and childbirth—when there are alternative means for enabling families to flourish is neither constitutional nor plausibly characterized as promoting life.

Beyond Traditional IP: Addressing Regulatory Barriers

Cynthia M. Ho (Loyola University of Chicago), Beyond Traditional IP: Addressing Regulatory Barriers, Intellectual Property, COVID-19, and the Next Pandemic: Diagnosing Problems, Developing Cures (Cambridge U. Press, Forthcoming 2023):

The COVID pandemic has underscored that IP can limit the ability to addressing public health crises because IP owners have the legal right to bar others from making needed supplies. However, what is less well understood yet critical to making medical treatments available are IP-related barriers existing in regulatory laws that complement traditional IP protection. In other words, even if a potential manufacturer of a needed treatment can obviate patent and trade secret hurdles, that manufacturer could be thwarted due to less well understood regulatory barriers.

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A Legislative Cuff around the Pharmaceutical Industry in Pakistan

Shan Ali (Bahria University Islamabad), Hamza Khalid Niazi (Independent), Syed Zaheer Hussain Shah (Bahria University Islamabad), Sadia Tanveer (Independent), A Legislative Cuff around the Pharmaceutical Industry in Pakistan, 8 J. Islamic Countries Soc’y Statistical Sciences 3 (2022):

The profit-oriented pharmaceutical industry, carrying its shady designs beyond ethical considerations, is exploiting the patent rights laws of Pakistan, against the very interests of poverty-stricken people, which is sheer legal opportunism, necessitating a comprehensive set of legal rules under a sincere and holistic approach for the best protection of the right to health and medical transparency. The case study is done to countercheck the effectiveness of judicial precedent combined with relevant legislation on the successful implementation of the International Patent regime in accessibility and availability of medicines. The research also maps out significant strategies to be adopted by Pakistan for the protection of patent rights but not at the expense of grievances caused by pandemics or common person health measures.