HealthLawProf Blog

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

Saturday, June 25, 2022

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)

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)

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)

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)

Friday, June 24, 2022

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)

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)

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)

Thursday, June 23, 2022

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)

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)

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)

Wednesday, June 22, 2022

Harvested Cattle, Slaughtered Markets?

Robert Taylor (Auburn University), Harvested Cattle, Slaughtered Markets?, SSRN (2022):

Reasons for intense concern about competition and fairness in cattle and beef markets are obvious from charts of retail beef prices, beef packer profit margins, grocery profit margins, and returns to independent cattle feeders.

June 22, 2022 | Permalink | Comments (0)

Big Tech and the Smartification of Agriculture: A Critical Perspective

Felix Maschewski (Humboldt University of Berlin), Anna-Verena Nosthoff (University of Vienna), Big Tech and the Smartification of Agriculture: A Critical Perspective in The State of Big Tech (IT for Change, eds., 2022):

The paper outlines critical aspects concerning the increasing use of big data in agriculture and farming. In particular, the aim is to shed light on the emerging dominance of the platform economy in the field of agriculture and food production. To analyze those power structures shaping this dynamic, we start with brief observations on the general relationship between digitization and agriculture and explain the platform economy, its general business model, and the proprietary forms of market power emerging from it. Subsequently, we analyze the implications of the involvement of platform-economic companies in the agricultural sector. To do so, we critically examine several key examples that illuminate the strategies and ultimate objectives of those key tech players involved in this transition––particularly, two of the most dominant cloud providers, Alphabet and Amazon. Finally, we identify the main problems that can potentially emerge, and that can already be observed, from Big Tech’s involvement in agriculture and food production: (1) epistemic asymmetry (2) the erosion of privacy (3) potential harms to smaller farms and farmers, and (4) systemic dependencies on a monopolist data infrastructure. As we argue, these four dimensions are not only essential to take into account, but they also ultimately need to be responded to politically. From a policy perspective, to maintain data justice and epistemic symmetry, and to avoid the risks highlighted, we suggest––next to stressing the need for critical scholarship––to establish a democratically governed data trust, rely on open source technology, and fundamentally commit to the principle of collective data sovereignty.

June 22, 2022 | Permalink | Comments (0)

Uprooting Roe

Jessie Hill (Case Western Reserve University), Mae Kuykendall (Michigan State University), Uprooting Roe, 12 Houston Law Review Online 50 (2022):

The U.S. Supreme Court is likely poised to overturn Roe v. Wade in a matter of months. Yet, the roots of Roe run both wide and deep, and to uproot Roe would be to uproot the Constitution’s promise of gender equality in a radical way. Just as the Supreme Court’s jurisprudence of reproductive liberty freed people with reproductive capacity from having their destinies and status tied to their biology, an uprooting of Roe and its companion principles will restore the iron rules of gender difference and return women to their common-law status as lacking self-ownership and equal citizenship.

June 22, 2022 | Permalink | Comments (0)

Collective Cognitive Capital

Emily R. Murphy (UC Hastings Law), Collective Cognitive Capital, 63 Wm. & Mary L. Rev. 1347 (2022):

This Article calls for a new project for law and neuroscience. It outlines a structural, not individual, application of brain and behavioral science that is aligned with the general goal of basic science research: improving the lives of citizens with a better understanding of the human experience. It asks brain and behavioral science to move explicitly into public policy territory, and specifically onto ground more traditionally occupied by economists—but in ways the project of “behavioral economics” has not yet ventured. Put simply, policy analysts should focus on brains—“collective cognitive capital”—with the same intensity with which they focus on money, rights, or other policy metrics.

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June 22, 2022 | Permalink | Comments (0)

Monday, June 20, 2022

Program Necessity or Regulatory Inequity: Collection of Indemnity Overpayments Under the Federal Crop Insurance Program

Abbey Bufkin (University of Mississippi), Program Necessity or Regulatory Inequity: Collection of Indemnity Overpayments Under the Federal Crop Insurance Program, SSRN (2022):

The Federal Crop Insurance Program provides farmers and ranchers the ability to purchase federally reinsured crop insurance policies to protect against financial losses due to a variety of perils, including adverse weather and market conditions. These federal crop insurance policies are issued by private sector companies pursuant to an agreement with the federal government known as a Standard Reinsurance Agreement. This agreement mandates Approved Insurance Providers to follow all federal crop insurance policy terms, rules, regulations, and procedures in the sale and service of these policies. Claims paid under federal crop policies are subject to audit and review. If any error is determined to have occurred in the payment of indemnity, the Approved Insurance Provider which issued the policy is required to correct the claim. If the claim error resulted in an indemnity overpayment, the Approved Insurance Provider is to recover the overpaid indemnity from the insured. Under the current regulatory scheme, no time limitation exists for identifying a claim error and seeking an indemnity overpayment if such has occurred. Further, in determining whether an insured is responsible for repaying indemnity there is no requirement that the error associated with the erroneous payment be due to the actions or omissions of the insured. This article addresses these regulations requiring repayment of erroneously paid indemnity and the inequities arising from the current regulatory scheme. Specifically, the lack of any time limitation for identifying an indemnity overpayment and seeking repayment of incorrectly paid indemnity leaves an insured vulnerable to requests for repayment on an open-ended basis with no claim finality. Additionally, the fact that the error or mistake which caused the overpayment was in no manner the result of the insured’s conduct is not a consideration in whether repayment can be obtained from the insured.

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June 20, 2022 | Permalink | Comments (0)

Extending Pandemic Flexibilities for Opioid Use Disorder Treatment: Authorities and Methods

Bridget C.E. Dooling (GW Regulatory Studies Center), Laura Stanley (George Washington University), Extending Pandemic Flexibilities for Opioid Use Disorder Treatment: Authorities and Methods, 106 Minn. L. Rev. (2021):

This essay evaluates two specific flexibilities the government granted during the COVID-19 pandemic that made it easier for patients to access life-saving medications to treat opioid use disorder: buprenorphine and methadone. First, the Drug Enforcement Administration (DEA) allowed practitioners to prescribe buprenorphine using telemedicine without first conducting an in-person medical exam. Second, the Substance Abuse and Mental Health Services Administration (SAMHSA) made it easier for patients to have a take-home supply of methadone, reducing many patients’ need to make a daily trip to an opioid treatment program. While it is still early, there is some evidence that these flexibilities are working well for patients. Patients and practitioners worry that these flexibilities will come to an end after the pandemic, and one of the federal agencies involved has indicated that it lacks the legal authority to extend its flexibility beyond the pandemic. We disagree. At a political level, the White House Office of National Drug Control Policy has indicated that extending pandemic flexibilities for treating opioid use disorder is a priority for the Biden administration, and this essay offers a roadmap for the executive branch to extend these flexibilities using existing authority.

June 20, 2022 | Permalink | Comments (0)

Storms in Sunny States: Fraud in the Addiction Treatment Industry

Rachel Rein (Columbia University), Storms in Sunny States: Fraud in the Addiction Treatment Industry, Am. U. Wash. College of L. Health L. & Pol’y Brief (2022):

This paper studies health care fraud in the drug and alcohol treatment industry: what it is, how it happens, and how to stop it. The paper aims to answer, what are the problems posed by health care fraud and abuse in the substance abuse recovery industry? What are the prevention and enforcement goals? And when do authorities fail to meet these goals? The general problem this paper identifies and agrees with is that the drug recovery industry is still victim to high levels of health care fraud despite recent efforts to fight fraud. As a result, vulnerable patients suffer in subpar treatment centers. The specific problems this paper identifies are as follows. First, one key federal statute targeting health care fraud in the addiction industry is unclear and provides too-lenient penalties. Furthermore, regulatory guidance for such statutes is absent. Finally, inconsistent accreditation and licensing standards pave the way for fraudulent providers to fly under the radar.

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June 20, 2022 | Permalink | Comments (0)

The Climate Crisis and Agriculture

Nathan Rosenberg (University of Arkansas), Peter Lehner (Earthjustice), The Climate Crisis and Agriculture, 52 Env’t L. Reporter (2022):

This Article, excerpted from Farming for Our Future: The Science, Law, and Policy of Climate-Neutral Agriculture (ELI Press 2021), outlines the threats climate change poses to agriculture and provides an overview of agricultural greenhouse gas emissions at the global, U.S., and state levels. It further details the sector’s sources of emissions, explains how the U.S. Environmental Protection Agency’s standard analysis significantly understates agriculture’s climate change impact, and identifies uncertainties inherent in measuring the impacts of wide-scale biological systems. In contrast to government estimates, we argue that agriculture in the United States is responsible for one-quarter to one-third of national greenhouse gas emissions. We conclude by assessing agriculture’s capacity to contribute to massive decreases in emissions, sometimes called “deep decarbonization.”

June 20, 2022 | Permalink | Comments (0)