HealthLawProf Blog

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

Sunday, July 21, 2024

A Human Right to Daily Access to Fresh Air Beyond Prisons in Australia?

Laura Grenfell (University of Adelaide), Anita Mackay (La Trobe University), Meribah Rose (La Trobe University), A Human Right to Daily Access to Fresh Air Beyond Prisons in Australia?, Australian J. of Hum. Rts. (2023):

This article considers the international standard of daily access to fresh air, set out by the Mandela Rules/UN Minimum Rules for the Treatment of Prisoners, and whether it applies beyond prisons in Australia. This standard is part of the obligation to treat all those deprived of their liberty humanely, which is set out in Article 10 of the International Covenant for Civil and Political Rights. The article reveals the extent to which this standard is currently reflected in corrections legislation across Australian jurisdictions. It analyses recent Australian cases/investigations relating to access to fresh air in prison settings, as well as the investigations/inquiries into the treatment of travellers in hotel quarantine and residents of public housing towers as part of government COVID-19 measures. The article draws on international jurisprudence designed to guide Australian lawmakers and policymakers in setting detention conditions. It notes that Australia is commencing a detention monitoring scheme under the Optional Protocol to the Convention against Torture which requires that inspectors use human rights-based standards.

July 21, 2024 | Permalink | Comments (0)

Contracts and Intellectual Property Rights in Translational R&D – Furthering Safeguards in the Public Interest

Mark Anderson (University College London), Naomi Hawkins (University of Sheffield), Alison Slade (University of Leicester), Contracts and Intellectual Property Rights in Translational R&D – Furthering Safeguards in the Public Interest, 42 Nat. Biotechnol. (2024):

Intellectual property (IP) rights play a central role in debates around access to new technologies. The challenge of balancing private innovation incentives such as patents with public access to the fruits of innovation is particularly acute in the healthcare field. This paper argues that greater attention to the contractual terms in research and commercialisation agreements throughout the translational development chain is a necessary and practically realisable way to achieve an equitable balance for all stakeholders. Such an approach would complement current efforts, such as, for example, the adoption, adaptation or amendment of national and international legal instruments. However, our proposal has the potential to be adopted without global agreement or even any changes to national legislation. Together, key stakeholders in the translational research chain, including public and charitable funders, universities, and commercial companies, have the ability to make important changes to policies and practices and to reflect them in contractual arrangements in order to enhance the wider public interest.

July 21, 2024 | Permalink | Comments (0)

Saturday, July 20, 2024

When mRNA Technology Meets Patent Law: Innovation, Barriers, and the Public Health

Tolulope Anthony Adekola, When mRNA Technology Meets Patent Law: Innovation, Barriers, and the Public Health(2023):

The success of messenger ribonucleic acid (mRNA) technology during the COVID-19 pandemic has ushered in a new era of vaccine and therapeutic development. In this rapidly evolving field, top biotech and biopharma companies are constantly searching for new opportunities to create innovative treatments and vaccines. However, the landscape of mRNA patents is getting complicated and dense, with an accumulation of partially overlapping patent rights that require multiple rights holders' permission for use and commercialization. Additionally, there are several pending patent lawsuits related to key components of the mRNA technology which have strong implications for follow-on innovation and technology diffusion in the field. The case of mRNA technology– as often happens with emerging technologies – is therefore emblematic of the policy dilemma faced by patent law as to how to balance economic incentives in a cumulative innovation setting. The paper maps out relevant legal factors that, under different conditions, might aggravate or mitigate the potential negative effects of patents in the field. While the paper presents the results of the exploratory phase of research, it sets a framework for the further, more targeted examination of the identified issues.

July 20, 2024 | Permalink | Comments (0)

To Waive or Not to Waive: The Debate and Analysis of TRIPS Waiver

Shuwen Xu (Shandong University), To Waive or Not to Waive: The Debate and Analysis of TRIPS Waiver, 18 Asian J. of WTO & Int’l Health L. and Pol’y (2023):

The COVID-19 pandemic has reignited the decades-long debate over intellectual property rights (hereinafter “IPRs”) and global inequitable access to medical products. After heated debates over South Africa and India’s IPRs waiver proposal, on June 17, 2022, the World Trade Organization (WTO) members finally agreed to waive patent rights on COVID-19 vaccines with limited conditions 
and delayed the discussion on waiver extension to COVID-19 diagnostics and therapeutics. In this battle against COVID-19, it is true that the global community has made progress in successfully developing effective medical products, but then the inequity in access to those products between developed and developing countries causes it to be further behind than it was when it made progress. The virus never distinguishes between rich and poor countries, and access to vaccines, diagnostics and therapeutics shouldn’t either. This article argues that waiving IPRs on COVID-19 medical products could improve global access to them. It compares both sides of the debate and emphasizes that a broader coverage of types of IPRs and pharmaceutical products is necessary to achieve global equitable access to COVID-19 vaccines and pharmaceutical products. In addition to lowering IPR barriers through the Waiver, increasing manufacturing capacity and re-distributing the global stockpile are also important solutions to making pharmaceutical products available to those in need.

July 20, 2024 | Permalink | Comments (0)

Friday, July 19, 2024

Inverse Integration and the Relational Deficit of Disability Rights Law

Yaron Covo (Yale University), Inverse Integration and the Relational Deficit of Disability Rights Law, 124 Colum. L. Rev. (2024):

 

Integration has long been a central tenet of U.S. disability law. In both doctrine and scholarship, however, disability integration has been understood to operate in only one direction: integrating disabled persons into mainstream society. This conventional approach has overlooked a different model, inverse integration, whereby nondisabled persons enter or participate in disability-focused settings or activities. As this Article demonstrates, inverse integration is surprisingly popular. For example, nondisabled children study in special education programs, nondisabled persons reside in housing projects for disabled individuals, hearing actors perform in Deaf theaters, and nondisabled athletes compete in wheelchair sports.

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July 19, 2024 | Permalink | Comments (0)

Professional Field-work: Constructing Global Health Law as an 'Emerging Field'

Richard Clements (Harvard Law School), Professional Field-work: Constructing Global Health Law as an 'Emerging Field', 15 Forthcoming in Transnat’l Legal Theory (2024):

Constructing international legal fields is the work of experts. Such experts struggle over a field’s substantive content, normative direction and formal boundaries. Less commonly observed are the ways in which fields are described as part of such work. In global health law, experts have used the term ‘emerging field’ to capture its ambivalent status between a non-field and an established field. In deploying this term, they demonstrate the term’s productive uses in establishing a plural, open-ended and experimental sphere of professional action that overcomes the criticisms of its predecessor, international health law. In theorizing the notion of ‘emerging field’ as an example of professional field-work, this article points not only to the multiple registers of this nascent governance regime, but also to the changing style of international legal expertise itself.

July 19, 2024 | Permalink | Comments (0)

Thursday, July 18, 2024

Achieving the Human Right to a Caring Society in an Aging America

Alan S. Gutterman, Achieving the Human Right to a Caring Society in an Aging America (2024):

Caregiving includes activities undertaken by others to ensure that those with a significant ongoing loss of physical or mental capacity can maintain a level of ability to be and to do what they have reason to value and involves a variety of services provided in a number of places and by different groups of caregivers ranging from care in the home from unpaid family members and friends (mostly female), which is the most common form of long-term care; home-based services provided by paid caregivers, including caregivers found informally or through home health care agencies and healthcare professionals (i.e., nurses, home health care aides and therapists); and services provided by health and care professionals in institutional settings such as nursing homes or community-based adult day centers. Caregiving for older persons is an important issue, regardless of how and where the care is provided, since the data shows that the global population over age 65 will more than double over the next three decades, and steps need to be taken to determine the best means to fund and otherwise support the services that will be needed to maintain the physical and mental wellbeing of the most vulnerable members of this group. While there is no international human rights instrument specifically addressing long-term care for older persons, the human rights of older persons with respect to long-term care can be derived from a combination of several different rights explicitly recognized in international human rights. This book discusses the human rights law foundation for providing older persons with high quality long-term care alternatives and considers the current state of institutional care in nursing homes and assisted living centers, which is especially relevant in the aftermath of the Covid-19 pandemic. The book also describes the sweeping impact that caregiving provided outside of institutions by family members and friends has on all aspects of society and the steps that are being proposed to reduce economic, physical, and psychological stress on millions of older persons and their caregivers through development of an “infrastructure of care” and creation of “caregiving-friendly workplaces”.

July 18, 2024 | Permalink | Comments (0)

A Tale of the Tails: The Value of a Statistical Life at the Tails of the Age Distribution

Thomas J. Kniesner (Claremont Graduate University), W. Kip Viscusi (Vanderbilt University), A Tale of the Tails: The Value of a Statistical Life at the Tails of the Age Distribution (IZA Discussion Paper No. 16867) (2024):

The considerable literature on the value of a statistical life (VSL) documents the wage-mortality risk tradeoffs for the working population. Regulatory analyses often must monetize risks to populations at the tails of the age distribution. Because of the longer life expectancy for children, there have been proposals to add a premium to their VSL, which would generate an inconsistency with revealed preference estimates of the VSL trajectory over the life cycle. The shorter life expectancy among older people has led to various arbitrary senior discounts for seniors' life expectancy. Application of the value of a statistical life year (VSLY) can address valuation of small changes in life expectancy. Examples of inappropriate age adjustments that we discuss include practices by the Consumer Product Safety Commission and the Environmental Protection Agency.

July 18, 2024 | Permalink | Comments (0)

Monday, July 8, 2024

What the New York City Marathon Can Teach Us About Equitable Access to Vaccines, Bill of Health

Ana Santos Rutschman (Villanova University), What the New York City Marathon Can Teach Us About Equitable Access to Vaccines, Bill of Health (2023):

This piece surveys a proposal for the adoption of a multi-modal system for allocating vaccine doses during large transnational outbreaks of infectious diseases. The chosen allocative criteria (public health need; country-income level; qualification through funding; and, subsidiarily, a modified lottery system) are adapted from a current embodiment of allocative multi-modality outside the context of public health: the New York City Marathon.

July 8, 2024 | Permalink | Comments (0)

Farmed Animal Welfare: Improvements and Developments (North America)

Delcianna Winders (Vermont Law School), Farmed Animal Welfare: Improvements and Developments (North America)(Handbook on Global Animal Law, Oxford University Press, Anne Peters, Kristen Stilt, & Saskia Stucki, eds.) (forthcoming 2024):

Recent North American legal developments pertaining to farmed animal welfare include increased, but still limited, cruelty prosecutions; a ruling from the U.S. Supreme Court upholding states’ rights to enact bans on the sale of products made using cruel confinement systems; continued efforts to deregulate slaughter, including to increase or remove slaughter speed limits; increased, but still inadequate, attention to humanewashing; and unprecedented animal welfare requirements for certified organic products. Overall, these developments reflect heightened attention to farmed animal welfare but still limited legal oversight. Some of these developments, particularly the decision establishing the constitutionality of bans on products made using cruel confinement systems and organic animal welfare standards, might serve as a foundation for more robust legal requirements. Other potential trajectories also warrant heightened attention, including the creation of a non-criminal regulatory licensing, inspection, and enforcement regime with detailed welfare standards and an independent animal protection agency.

July 8, 2024 | Permalink | Comments (0)

Sunday, July 7, 2024

Restoring Mai Mapingure's Equal Citizenship

Charles Ngwena (University of Pretoria), Rebecca J. Cook (University of Toronto), Restoring Mai Mapingure's Equal Citizenship (Frontiers of Gender Equality: Transnational Legal Perspectives, University of Pennsylvania Press, Rebecca J. Cook, ed.) (2023):

This chapter rewrites the judgment of the Supreme Court of Zimbabwe in the Mildred Mapingure v. Minister of Home Affairs et al. The authors, writing as judges, identify the gendered harms of Zimbabwe's Termination of Pregnancy Act of 1977 and its application to Mai Mapingure, a Zimbabwean woman denied an abortion to which she was legally entitled under the Act after being raped. Its criminal restrictions and procedures stereotype women as lacking agency. Its application is distorted by the gender biases of state officials, including doctors, policemen and judges. The Supreme Court blames Mai Mapingure, a poor woman, for not hiring a lawyer to negotiate the criminal justice system to access abortion services and fails to address the structural discrimination. The rewritten judgment explains how the 2013 Constitution's transformative vision requires the restoration of women's equal citizenship in all sectors, including the health sector. The judgment acknowledges the social subordination of pregnant women, and reasons that the discrimination is intersectional, with gender, pregnant status and poverty causally implicated. She is denied equal exercise of her rights to personal security, freedom from cruel treatment, conscience and health care in violation of Zimbabwe’s 2013 Constitution. The authors order remedies to restore Mai Mapingure's dignity and substantive equality. They award compensation for the rearing and educating her minor child. The 1977 Act is declared invalid. The state is ordered to investigate abuses against pregnant women, publish guidance to ensure transparent and dignified access to abortion care, and develop a national plan to transform the discriminatory health institutions and practices. Affirmative measures include gender-sensitive training, guidance for providers and the establishment of accountability mechanisms. The judgment aims to transform the circumstances causing violations through gender-specific remedies that acknowledge women's agency and equal citizenship. The rewritten decision shows how the application of substantive equality under Zimbabwe’s newest Constitution is necessary to remedy structural subordination of pregnant women in the health sector.

July 7, 2024 | Permalink | Comments (0)

Republic of Moldova: Pandemic Crisis and Financing Mechanism of the Health Care

Andrei Petroia (Academy of Economic Studies of Moldova), Nina Surdu (Academy of Economic Studies of Moldova), Republic of Moldova: Pandemic Crisis and Financing Mechanism of the Health Care (2023):

In the wake of the pandemic, comprehending the profound impact on healthcare financing was an essential factor in order to assess the system's resilience, identify areas for improvement, and develop more robust strategies to safeguard public health during future crises.

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July 7, 2024 | Permalink | Comments (0)

Saturday, July 6, 2024

Prohibition 2.0: Critiquing the Generational Tobacco Ban

Christopher Snowdon (Institute of Economic Affairs), Prohibition 2.0: Critiquing the Generational Tobacco Ban (Inst. of Econ. Aff. (IEA), Briefings) (2023):

The UK government's proposal for a generational tobacco ban targeting individuals born after 2008 is critiqued in this article. The critique emphasizes the challenge to adult autonomy, predicts potential absurdities in age-based restrictions, and warns of a potential rise in the black market. Drawing insights from Bhutan's tobacco prohibition, the efficacy of such a ban is questioned, with a focus on its impact on smoking cessation and healthcare costs. The article suggests that emerging reduced-risk nicotine products, like e-cigarettes, may provide a more effective alternative to traditional tobacco bans.

July 6, 2024 | Permalink | Comments (0)

A Critical Appraisal on Compliance With the Compulsory Treatment and Care for Victims of Gunshot Act 2017

Timothy Olaniyi, A Critical Appraisal on Compliance With the Compulsory Treatment and Care for Victims of Gunshot Act 2017 (2023):

The Compulsory Treatment and Care for Victims of Gunshots Act 2017 guarantees the right to dignity and emergency treatment of gunshot victims and obligates the police and hospitals to render assistance and treatment to victims of gunshots.

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July 6, 2024 | Permalink | Comments (0)

Friday, July 5, 2024

U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, et al., Brief of Amicus Curiae Mountain States Legal Foundation in Support of Respondents

R. Trent McCotter (George Mason University), U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, et al., Brief of Amicus Curiae Mountain States Legal Foundation in Support of Respondents, Gray Center Separation of Powers Brief 24-05 (2024):

Amicus takes no position on the underlying merits of this case but supports Respondents because of a shared concern over the harm imposed by the Food and Drug Administration’s unlawful administrative-exhaustion regulation, which purports to prohibit a party from challenging “any” otherwise-final “administrative action” in court unless the party has first filed—and the FDA has denied—a “citizen petition” asking the FDA Commissioner himself to rescind or amend the challenged action that the FDA has already taken.

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July 5, 2024 | Permalink | Comments (0)

The Regulatory Capture of FDA’s Tobacco Policy - And How to Reverse It

Jeffrey Weiss, The Regulatory Capture of FDA’s Tobacco Policy - And How to Reverse It, 79 Food Drug and L. J. (forthcoming):

FDA's Center for Tobacco Products (CTP) has struggled to find a stable footing in its regulation of e-cigarettes/ENDS. In recognition of this fact, Commissioner Robert Califf asked the independent Reagan-Udall Foundation to conduct a review of CTP operations. Reagan-Udall's first recommendation was development by FDA of a five-year strategic plan. Critical to a sound plan will be for FDA to first understand how its tobacco policy has been captured by tobacco control advocacy groups (TCAG). It should then craft a going-forward strategy that is firmly rooted in the 2009 Tobacco Control Act (TCA) and the historic consensus on FDA-regulated harm reduction on which it was founded.

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July 5, 2024 | Permalink | Comments (0)

Thursday, July 4, 2024

Quality of Life for People with Mental Illness Employed in Extended Employment Programs in two Arab Towns in Israel: An Exploratory Study

Leena Badran (University of California, Davis), Stephen A. Rosenbaum (University of California, Berkeley), Arik Rimmerman (University of Haifa), Quality of Life for People with Mental Illness Employed in Extended Employment Programs in two Arab Towns in Israel: An Exploratory Study, 14 Frontiers in Psychiatry (2023):

This study aims to examine the quality of life (QOL) for people with psychiatric disabilities who are engaged in extended employment programs (homogeneous versus heterogeneous) in the Arab-populated Triangle Area of Israel. The homogeneous program participants are exclusively Arab while the heterogeneous program includes both Arabs and Jews. A quantitative research study involved 104 adults with psychiatric disabilities engaged in two communal extended employment programs. Participants completed demographic (age, gender, marital status), religion (Muslim, Jewish, Christian), dichotomous nationality variable (Jewish/Arab), years of education, and employment questionnaires. 

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July 4, 2024 | Permalink | Comments (0)

The Economic Analysis of Exclusive Contracts in Two-Sided Markets: Federal Trade Commission vs. Surescripts

David S. Evans (Market Platform Dynamics), The Economic Analysis of Exclusive Contracts in Two-Sided Markets: Federal Trade Commission vs. Surescripts, Revue Concurrences (2024):

Over the last 15 years in the United States electronic networks have almost entirely displaced fax, phone, and paper for transmitting prescription information between doctors and pharmacies and for transmitting insurance information between pharmacy benefits managers and doctors. In 2019 the U.S. Federal Trade Commission sued Surescripts alleging the company has had monopolies over these networks and, beginning in 2010, had maintained those monopolies through loyalty pricing and other actual or de facto exclusive contracts. In 2023, the FTC secured a permanent injunction of the loyalty pricing contracts and of contracts that would have similar effects. The FTC and Surescripts agreed that the networks were two-sided transaction platforms as defined by the Supreme Court in American Express. The economic analysis of the exclusive contracts illustrates the role of indirect network effects, critical mass, and multihoming in examining dynamic competition in platform markets. This paper provides a primer on those concepts and how they were applied to health tech markets in the Surescripts case. This discussion may be relevant for analyzing antitrust cases involving two-sided transaction platforms with exclusive contracts in other markets with strong indirect network effects.

July 4, 2024 | Permalink | Comments (0)

Wednesday, July 3, 2024

Genetic Patents and the Sustainable Development Goals

Jorge L. Contreras (University of Utah), Genetic Patents and the Sustainable Development Goals (The Elgar Companion to Intellectual Property and the Sustainable Development Goals, Ch. 5) (2024):

This chapter addresses the patenting of genetic and genomic sequence data, including that derived from humans, animals, plants and pathogens, as well as tools for editing the genomes of organisms. Such patents implicate a number of the U.N. Sustainable Development Goals (SDGs) including SDG2 (End hunger, achieve food security and improved nutrition and promote sustainable agriculture), SDG3 (Ensure healthy lives and promote well-being for all at all ages), SDG9 (Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation) and others. This chapter concludes with recommendations regarding legal and policy measures in the area of genetic patenting that can further promote achievement of the SDGs.

July 3, 2024 | Permalink | Comments (0)

A Financial Case for a Medical-Legal Partnership: Reducing Lengths of Stay for Inpatient Care

Barak D. Richman (Duke University), Breanna Barrett (Duke University), Riya Mohan (Duke University), Devdutta Sangvai (Duke University), A Financial Case for a Medical-Legal Partnership: Reducing Lengths of Stay for Inpatient Care, 51 J. L. Med. & Ethics (2023):

While Medical-Legal Partnerships (MLPs) have improved the health and well-being of the people they serve, most healthcare institutions will only invest in an MLP if they are convinced that doing so will improve its balance sheet. This article offers a detailed estimation of the cost savings that an MLP targeted toward the most acute legal needs would accrue to an academic medical center (AMC) in North Carolina.

July 3, 2024 | Permalink | Comments (0)