HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Monday, June 27, 2022

How Relational Contracting Can Solve Medicaid Long-Term Care's Accountability Crisis

Lukas Gemar (affiliation not provided to SSRN), How Relational Contracting Can Solve Medicaid Long-Term Care's Accountability Crisis, U. Penn. L. Rev. (Forthcoming):

There are serious accountability problems in Medicaid managed long-term care. Better court enforcement of a protected interest in benefits, along with federal oversight, can help fill some accountability gaps. But the greatest potential for increased accountability lies in state investment in relationships with managed care organizations through formal relational contracting.

June 27, 2022 | Permalink | Comments (0)

Unequal Representation: Women in Clinical Research

Allison Whelan (University of Pennsylvania), Unequal Representation: Women in Clinical Research, Cornell L. Rev. Online (2021):

This Article engages with legal and social history to analyze the present-day consequences of two distinct, yet related historical wrongs: the exclusion of pregnant women and women of child-bearing potential from medical research and the unknowing or unwilling medical experimentation on women of color. It provides a critical contribution to the ongoing discourse about clinical trial representation, arguing in favor of policy considerations rooted in law and society to address the harms caused by this deeply rooted and problematic history.

June 27, 2022 | Permalink | Comments (0)

The Affordable Care Act and Women’s Self-Employment

Margaret Blume-Kohout (Gettysburg College), The Affordable Care Act and Women’s Self-Employment, Feminist Econ. (Forthcoming):

The United States’ Affordable Care Act (ACA) of 2010 improved and expanded availability of non-group health insurance. Previous studies have shown that women in the US workforce value health insurance more highly than men do. Because prior to the ACA self-employed individuals did not have guaranteed access to affordable health insurance coverage, women’s relatively lower rate of self-employment may partly have reflected their greater ‘job lock’ due to employer-based health insurance. This paper employs nationally-representative survey data for 2009-2018 and a quasi-experimental difference-in-difference modeling approach and finds that unmarried women’s probability of self-employment increased by 1.2 percentage points in 2015-2018, after the ACA’s expansion of non-group health insurance came into effect. Among women who have never married, overall probability of self-employment increased by 1.2-1.5 percentage points versus trend, and the probability of transitioning into full-time self-employment increased by 0.9 percentage points.

June 27, 2022 | Permalink | Comments (0)

Expanding the Role of Bioethics in Translational Research

Mark A. Rothstein (University of Louisville), Expanding the Role of Bioethics in Translational Research, 50 J.L. Med. & Ethics 3 (2022):

Translational research attempts to accelerate and increase the significance of research progressing from bench to bedside. Support from the NIH through its institutional grant program has increased the prominence and importance of translational research. The inclusion of a broadly based bioethics component to translational research presents an opportunity for bioethics scholars to address fundamental social issues, including the effects of translational research projects on public health, health equity, and human flourishing. Large-scale bioethical inquiries could examine research priorities, unintended consequences of research, and access to and uptake of research discoveries.

June 27, 2022 | Permalink | Comments (0)

Sunday, June 26, 2022

Ironing out the Wrinkles: Reforms to Crown Use and Compulsory Licensing to Help Prepare the Patents Act 1977 for the Next Health Crises

John Liddicoat (University of Cambridge), James Parish (King's College London), Ironing out the Wrinkles: Reforms to Crown Use and Compulsory Licensing to Help Prepare the Patents Act 1977 for the Next Health Crises, 4 Intellectual Property Quarterly 245 (2021):

This article recommends four reforms to the Patents Act 1977 owing to concerns raised by health crises. The exclusive rights granted by patents create the possibilities that patentees may charge unreasonable prices or limit the supply of their inventions, thereby harming public health. These possibilities seldom arise, but patent law ought to provide effective responses if they do. Compulsory licences and Crown use are designed for these purposes; however, this article finds shortcomings in both mechanisms. The grounds for compulsory licences are too narrow, and two procedural aspects make it too slow. This article proposes reforming all three defects. By contrast, Crown use can be invoked swiftly and on a broad variety of inventions. Yet, an amendment introduced in 1988, which compensates patentees for lost profit, can make Crown use unaffordable, hampering the mechanism’s usefulness. This article proposes reform to suspend the compensation during emergencies, thereby ensuring the affordability of Crown use during future health crises.

June 26, 2022 | Permalink | Comments (0)

Reflections upon Alcohol in Our Lives: 10 Years after the Law Commission Report

Sir Geoffrey Palmer QC (Victoria University of Wellington), Reflections upon Alcohol in Our Lives: 10 Years after the Law Commission Report, SSRN (2022):

A speech delivered to Alcohol Action New Zealand’s annual meeting on 13 August 2019. The speech provides an overview of the Law Commission’s 2008–2010 inquiry into New Zealand’s laws concerning the sale and supply of alcohol, as well as the Government’s response. It argues that the Government’s Sale and Supply of Alcohol Act 2012 did not follow the Law Commission’s recommendations in many important respects, and that it constitutes a substantially watered down and less effective version of the Alcohol Harm Reduction Act recommended by the Commission. The address makes the case for using deliberative democracy techniques to reform New Zealand’s liquor laws once again.

June 26, 2022 | Permalink | Comments (0)

Reproducing Indonesia’s Illiberal Legalism amid COVID-19: Public Health Crisis as a Means of Accumulation

Rafiqa Qurrata A'yun (University of Indonesia), Abdil Mughis Mudhoffir (State University of Jakarta), Reproducing Indonesia’s Illiberal Legalism amid COVID-19: Public Health Crisis as a Means of Accumulation, 22 Aus. J. Asian L. 21-44 (2022):

While many nations have struggled to find the best strategies for controlling the Covid-19 pandemic, the government of Indonesia has shown little interest in it. This is evident from Indonesia’s messy handling of the outbreak, which continues to worsen the public health crisis. However, under the framework of disorder that constitutes Indonesia’s illiberal political-legal system, where the rule of law is largely absent, the crisis is a means to the accumulation of wealth and power. Instead of seriously containing the outbreak, the government tends to make decisions that maintain crisis, as this can create wider opportunities to extend state power and facilitate rent-seeking interests. The issuance of highly contentious regulations—which pose serious threats to human rights, extend state power, and undermine notable post-1998 institutional reforms—in the middle of the pandemic is an example of this tendency. Among these regulations are the Presidential Regulation in Lieu of Law (Perppu) on Covid-19, the Coal and Mineral Mining Law, the Constitutional Court Law, and the Omnibus Job Creation Law. The way these regulations were issued shows disregard for the principles of law-making process, such as transparency and public participation, and accentuates the illiberalism within Indonesia’s political-legal system. As such, Indonesia’s messy handling of the pandemic is not simply due to lack of leadership and institutional capacity; nor is it a result of democratic decline, as many have argued. Rather, it is an outcome of the longstanding illiberal political-legal system in which exploiting public health crises for predatory interests is inevitable.

June 26, 2022 | Permalink | Comments (0)

Impact Of Digital Rights And Digital Rights Violations On Persons With Disabilities

Bizibrains Okpeh (Nigerian Bar Association), Impact Of Digital Rights And Digital Rights Violations On Persons With Disabilities, SSRN (2021):

There is no gainsaying that digitalisation has become one of the hallmarks of the 21st Century. Human interactions, commercial and social activities are increasingly being digitalised so much so that human existence is fast becoming intrinsically linked, integrated, or connected with “digital life”. This has been made possible by the advancement in Internet and Communication Technology (ICT) and the Internet of Things (IoT), which ensures the continuing development and invention of new smart technologies, applications, and software to facilitate, and in some instances anchor, human communications, interactions, and transactions, with more than 100 billion devices or applications now connected to the internet (Ford online news), sometimes creating “new and complex” rights, and dynamic perspective in human rights discourse often referred to as digital rights.

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June 26, 2022 | Permalink | Comments (0)

Saturday, June 25, 2022

Alcohol, Health and the Law Commission's Liquor Review

Sir Geoffrey Palmer QC (Victoria University of Wellington), Alcohol, Health and the Law Commission's Liquor Review, SSRN (2022):

An address to the Alcohol Advisory Council's “Working Together” conference, delivered on 15 May 2009. The address focuses on the health and injury-related consequences of alcohol consumption, from foetal alcohol disorders to chronic diseases. It argues that the risks associated with alcohol are not just confined to binge-drinkers, but are in fact universal. It also highlights the significant burden placed on government expenditure and health services by hazardous alcohol consumption.

June 25, 2022 | Permalink | Comments (0)

Uniformity, Experimentalism, and the Unfulfilled Promise of Differentiated Integration in EU Regulation of GMOs: Which Way Forward?

Patrycja Dabrowska-Klosinska (Independent), Uniformity, Experimentalism, and the Unfulfilled Promise of Differentiated Integration in EU Regulation of GMOs: Which Way Forward?, SSRN (2021):

EU governance in the field of agricultural biotechnology, especially authorizations for commercial use and cultivation of genetically modified organisms (GMOs), has always been an exemplary field of intense policy controversies leading to regulatory impasses. Notwithstanding repeated attempts to improve the functioning of the regime, the longstanding problems with insufficient democratic legitimacy of EU-level GM product approvals in comitology decision making have persisted, affecting the overall profile of the policy. This paper appraises the most recent reform of the GMO regime through a case study of the implementation of the Opt-out Directive 2015/412, which returned powers over GMO cultivation to the national level, from the perspective of differentiated integration (DI) in relation to other regulatory approaches, namely experimentalist governance (XG) and uniform regulation (UI). In order to do so, the paper addresses the conceptualization of the GMO regime, its successes and pitfalls, the origins of the DI reform, and national implementation in six Member States. The regulatory appraisal of the impact of the reform on the accommodation of diversity within the EU is carried out through the lens of the functioning of the Internal Market and GMO approvals through the comitology voting system. The paper establishes that the DI approach introduced by the 2015 Opt-out Directive failed to effectively foster accommodation of diversity in the GMO regime. It argues that this was due to the atypical mode of DI which was introduced in the system, and lack of exploitation of the opportunities offered by XG within the GMO regime. The paper shows that the reform reinforced asymmetries between Member States and did not fully address key problems of the GMO regime, including effective deliberation in comitology committees, pertinent national-level issues, and the need to revise the regulation in view of development of New Plant Breeding Techniques (NPBTs). Finally, the paper outlines three possible scenarios in the present situation. It argues that the most promising scenario would involve a combination of more radical DI and more extensive use of XG, including a complete return of decision-making powers over cultivation to the Member States and opening up debates about GMO authorizations to socio-economic and ethical-cultural factors beyond scientific risk assessment.

June 25, 2022 | Permalink | Comments (0)

Sobering up in South Africa: The Sin Tax Consequences of a Pandemic

Teresa Pidduck (University of Pretoria), Sumarie Swanepoel (University of Pretoria), Sobering up in South Africa: The Sin Tax Consequences of a Pandemic, 27 N.Z. J. Taxation L. & Pol’y 331-352 (2021):

In this article, the authors describe how the South African government has responded to the COVID‑19 crisis through fiscal measures, with a particular focus on the alcohol and tobacco prohibitions. Two severe and fairly unique measures implemented by the government were the prohibition of tobacco and the prohibition of alcohol (and related products). These two measures had an impact on the sin taxes received by the fiscus for the duration of the prohibitions but also had less obvious other short‑ and long‑term fiscal impacts, as well as various social, political and legal implications. This article reviews the tobacco and alcohol prohibitions, the responses by commentators and the short‑ and long‑term effects of these prohibitions on the fiscus and the economy, citing a particular need for a renewed focus on the excise duties on these two products.

June 25, 2022 | Permalink | Comments (0)

Overview of Nigeria’s Plant Variety Protection Act 2021 and the Impact of Section 43(2) on Plant Breeders

Ifeanyi E. Okonkwo (University of Cape Town), Blessing Udo (affiliation not provided to SSRN), Kayode Ikumelo (University of Ibadan), Overview of Nigeria’s Plant Variety Protection Act 2021 and the Impact of Section 43(2) on Plant Breeders, SSRN (2021):

In May 2021, the president of the Federal Republic of Nigeria, President Muhammadu Buhari finally assented to the Plant Variety Protection (PVP) Act 2021, to promote increased staple crop productivity for smallholder farmers in Nigeria and encourage investment in plant breeding and crop variety as well as protect new varieties of plants. This article analyses the pace of agricultural development in Nigeria before the enactment of the PVP Act in comparison with other African countries. This article also highlights the essential provisions and criticism of the Act and its prospects in enhancing innovation in the agricultural sector, attracting foreign direct investments, and contributing to Nigeria’s economic growth.

June 25, 2022 | Permalink | Comments (0)

Friday, June 24, 2022

Will the Past Be Prologue? Race, Equality, and Human Genetics

Allison Whelan (University of Pennsylvania), Michele Goodwin (University of California), Will the Past Be Prologue? Race, Equality, and Human Genetics, B.U. L. Rev. Online (2022):

This piece comments on Rewriting Nature: The Future of Genome Editing and How to Bridge the Gap Between Law and Science (2021) by Dr. Paul Enriquez. It discusses a few critical points that must be examined further when discussing genome editing: accessibility, affordability, and whether a greater understanding of the human genome can promote equality.

June 24, 2022 | Permalink | Comments (0)

U.S. State Approaches to Cannabis Licensing

Lucy Xiaolu Wang (University of Massachusetts Amherst), Nicholas Wilson (Ludwig Maximilian University of Munich), U.S. State Approaches to Cannabis Licensing, Int’l J. Drug Pol’y (Forthcoming):

U.S. states have taken varied approaches to licensing cannabis businesses under federal prohibition, but up to now there is limited research on cross-state licensing approaches. This paper provides a systematic analysis of the current licensing strategies taken by all states that have passed medical cannabis laws (MCLs)/recreational cannabis laws (RCLs). We construct comprehensive data on cannabis business licenses offered in each state, as well as metrics for license categories, cost, and issuance volume. We then analyze patterns between these metrics, also considering how long ago states implemented MCLs/RCLs, qualitative licensing aspects, state ideology and voting preference, and state cannabis taxation data. We observe that states tend to license medical cannabis more restrictively than adult-use cannabis: i.e., by offering licenses in fewer categories, at higher cost, in lower issuance volume, and more often mandating vertical-integration. Additionally, states that implemented MCLs/RCLs earlier tend to offer licenses in more categories, at lower cost, and in greater issuance volume. Further, though states that implemented MCLs recently lean conservative and Republican, we do not observe clear relationships between ideology or voting preference and licensing policy. In our supporting results, we observe that a greater share of states with complex licensing structures impose non-retail price cannabis taxes than states overall, and we discuss how states have changed their licensing policies over time.

June 24, 2022 | Permalink | Comments (0)

Universal Remedies, Section 706, and the APA

Ronald M. Levin (Washington University in St. Louis), Mila Sohoni (University of San Diego), Universal Remedies, Section 706, and the APA, Yale J. Reg. Notice & Cmt. Blog (2020):

Section 706 of the Administrative Procedure Act provides that a reviewing court “shall . . . set aside” agency action that it has found to be unlawful. In a provocative essay, Professor John Harrison argues that “set aside” should be read to mean “disregard” rather than “nullify”; therefore, he maintains, this language offers no support for the courts’ common practice of vacating unlawful agency rules, sometimes on a uniform or nationwide basis. Indeed, Harrison argues, Section 706 has nothing to do with judicial remedies, which the APA addresses in Section 703 instead.

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June 24, 2022 | Permalink | Comments (0)

Fish, Whales, and a Blue Ethics for the Anthropocene: How Do We Think About the Last Wild Food in the 21st Century?

Robin Kundis Craig (University Southern California), Fish, Whales, and a Blue Ethics for the Anthropocene: How Do We Think About the Last Wild Food in the 21st Century?, S. Cal. L. Rev. (2022):

One of the lesser celebrated threads of Christopher Stone's scholarship was his interest in the ocean—especially international fisheries and whaling. Fish and whales are among the "last wild food”—that is, species that humans take directly from the wild for food purposes. While whales are primarily cultural food, fisheries remain important contributors to the human diet globally. Indeed, the food security issues surrounding marine foods are increasingly being recognized as an important international and domestic component of human well-being and equity. These concerns helped to spur the Fall 2021 launch of the Blue Foods movement and the conscious incorporation of aquatic foods into the pursuit of the United Nations' sustainable development goals.

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June 24, 2022 | Permalink | Comments (0)

Thursday, June 23, 2022

How a Pandemic Plus Recession Foretell the Post-Job-Based Horizon of Health Insurance

Allison K. Hoffman (University of Pennsylvania), How a Pandemic Plus Recession Foretell the Post-Job-Based Horizon of Health Insurance, 71 DePaul L. Rev. (2022):

For many years, the health insurance that people received through their jobs was considered the gold standard, so much so that it came to be called “Cadillac coverage.” Just as Cadillac has lost its sheen, so has job-based health insurance coverage in many cases. This decline predated the COVID-19 pandemic, yet it has been, and will continue to be, hastened by it. The changes to job-based coverage have prompted people to ask: what’s next? This Article, written as part of the 2021 Clifford Symposium, suggests that the lessons from the pandemic could offer an opportunity fundamentally to rethink the way to pay for healthcare in the United States, perhaps opening a window for reform. Meaningful reform should imagine a better overall financing system ten to twenty years from now, rather than just trying to plug the most egregious holes in the existing system. This long view might produce counterintuitive results, likely focusing on reforms that will, in part or in whole, reach people who already have health insurance, rather than taking a laser focus to address the needs of the uninsured. But doing so could eventually produce a simpler and more equitable structure.

June 23, 2022 | Permalink | Comments (0)

Naomi Cahn (University of Virginia), Sonia M. Suter (George Washington University ), The Art of Regulating ART, 96 Chicago-Kent L. Rev. (2021):

This article examines the technologies of pre-implantation genetic testing (PGT) and germline gene editing (GGE) and the different potential approaches to their regulation. The regulatory issues sweep quite broadly. They involve not just the medical risks, which are relatively straightforward, but also broader social concerns about access to the technologies, equality and discrimination, implications for the disability community, eugenics, and exceptionalizing assisted reproductive technologies (ART) as compared with non-ART reproduction.

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June 23, 2022 | Permalink | Comments (0)

What's One More? Another Paper Attempting to Reconcile Abortion Jurisprudence and the Doctrine of Precedent Considering Dobbs v. Jackson Women’s Health

Kristen Dagher (University of Miami), What's One More? Another Paper Attempting to Reconcile Abortion Jurisprudence and the Doctrine of Precedent Considering Dobbs v. Jackson Women’s Health, SSRN (2022):

This paper will analyze a few major reproductive rights cases and abortion jurisprudence as it has been shaped by stare decisis, as well as how the Court's abortion jurisprudence has shaped stare decisis. Part I provides brief background on the doctrine of precedent, Supreme Court decisions that developed the zone of privacy, and the landmark decision of Roe v. Wade. Part II illustrates the shift of abortion jurisprudence in Planned Parenthood of Southeastern Pennsylvania v. Casey and illustrates the shift of abortion jurisprudence. Part III fast forwards to more recent Supreme Court abortion decisions in Whole Women's Health v. Hellerstedt and June Medical Services L.L.C. v. Russo to highlight deviation in stare decisis. Part IV covers the journey of Dobbs v. Jackson Women’s Health case and positions of the parties. Lastly, Part V is the analysis of the Dobb’s argument and my attempt to reconcile current abortion jurisprudence with precedent.

June 23, 2022 | Permalink | Comments (0)

Food Law’s Agrarian Question: Capital, Global Farmland, and Food Security in an Age of Climate Disruption

William Boyd (UCLA), Food Law’s Agrarian Question: Capital, Global Farmland, and Food Security in an Age of Climate Disruption in Research Handbook on International Food Law (Michael Roberts ed., 2022):

The global food system is once again in crisis. Food prices are hitting all-time highs, pushing hundreds of millions of people deeper into food insecurity and threatening political stability in regions around the world. Although food prices were already high (and rising) coming out of the COVID-19 pandemic, widespread inflation, the Russian invasion of Ukraine, and climate disruption have exacerbated the situation, raising the prospect that the world could be facing the worst food crisis since the Second World War. While it is relatively easy to identify the immediate triggers of the current crisis, there are deeper structural features of these recurring global food crises that need to be investigated. This chapter argues that the emerging field of international food law has an important role to play in uncovering the deep structures of the global agro-food system, paying specific attention to the role of law and legal arrangements in creating a global political economy in which close to one billion people do not get enough to eat. Drawing on agrarian political economy, critical approaches to international law, and the emerging field of law and political economy, the chapter takes the recent global land rush as a point of departure for investigating how capital (public and private) is taking hold of agriculture and land-based production, what this means for the organization of farming and food systems, for hunger and food insecurity, and for a world facing an accelerating climate crisis. In particular, the chapter highlights the role of law in enabling capital to take hold of agriculture and land-based production at two levels: the macro-level structuring mechanisms that have created the conditions for extensive land transactions and the commercialization of farming around the world (namely, international trade law, foreign investment law, and debt and structural adjustment) and the micro-level legal techniques that have enabled such transactions in particular places (namely, property, contract, and corporate law). By focusing on how law and legal arrangements constitute distributional struggles around land and food at multiple levels and across multiple geographies, the chapter provides a framework for investigating the contemporary dynamics of the global agro-food system, including the rise of global farmland as a new asset class, the recent global land rush, and the compounding global crises of food, land, and climate change.

June 23, 2022 | Permalink | Comments (0)