HealthLawProf Blog

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

Saturday, December 31, 2022

The Proposed COVID-19 TRIPS Waiver: Not a Silver Bullet but Part of a Solution for Africa’s COVID-19 Health

Franziska Sucker (University of the Witwatersrand), Kholofelo Kugler (Friedrich-Alexander Universität Erlangen-Nürnberg), The Proposed COVID-19 TRIPS Waiver: Not a Silver Bullet but Part of a Solution for Africa’s COVID-19 Health, MJIEL (2022):

From the outset, the proposed COVID-19 TRIPS waiver has captured the public attention, with various civil society organisations urging WTO Members to adopt it and criticising those who opposed it. We explore whether and to what extent the proposed waiver can contribute to addressing the critical COVID-19 medical products access limitations and assist African countries to abate their health crises. It becomes apparent that, even if adopted, the proposed waiver can only be part of the solution. It would remove the legal barriers that prevent African countries that protect IPRs from producing generic COVID-19 medical products or engaging in their parallel importation. However, the development or scaling up of manufacturing COVID-19 medical products requires finding new ways for knowledge sharing and cooperation. As such, the current crisis highlights the need to ensure that the monopoly power of IPRs do not exacerbate global public health emergencies.

December 31, 2022 | Permalink | Comments (0)

Tobacco Control and The Council of Europe: The Potential and Limits of the Collective Complaints Procedure of the European Social Charter

Giulia Bosi (Scuola Superiore Sant'Anna), Tobacco Control and The Council of Europe: The Potential and Limits of the Collective Complaints Procedure of the European Social Charter, Eur. J. Health L. (2022):

The role of the Council of Europe (CoE) in tobacco control remains largely unexplored. This paper aims to fill this gap, focusing on the CoE’s European Social Charter. Article 11 of the Charter protects the right to health, and adequate tobacco control measures are necessary to respect this article. This paper examines the potential and limits of the Collective Complaints procedure, one of the two monitoring mechanisms of the Charter, as a means to evaluate the compliance of national tobacco control measures with Article 11. It demonstrates that, so far, this mechanism has never been used in this way. However, although the Collective Complaints procedure presents several drawbacks, it should not be underestimated. Indeed, it possesses certain features, such as the collective nature of the complaint and the lack of the requirement of the exhaustion of domestic remedies, which might make it a particularly suitable tool for the abovementioned purpose.

December 31, 2022 | Permalink | Comments (0)

AI as a Medical Device: Between the Medical Devices Framework and the General AI Regulation

Anastasiya Kiseleva (Vrije Universiteit Brussel), AI as a Medical Device: Between the Medical Devices Framework and the General AI Regulation, Time to Reshape Digital soc’y, 40th Anniversary CRIDS, Conf. Book (2021):

This paper is the follow-up to my previous paper ‘AI as a Medical Device: Is It Enough to Ensure External Performance Transparency and Accountability?’ published in March 2020. Back then, the general approach to regulate artificial intelligence (‘AI’) was in its development stage. The analysis of AI used in healthcare was thus based on the Medical Devices Framework (‘MDF’) and identified three main issues of the framework: limitations in the regulated subjects (not enough considerations for the roles of users),limitations in the regulatory scope (focus on safety and performance rather than on transparency and accountability); limitations in procedures (self-learning nature of AI and data dependence are not sufficiently covered).

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December 31, 2022 | Permalink | Comments (0)

Turkey–Pharmaceuticals: The First WTO Arbitration for Appellate Review

Julia Ya Qin (Wayne State University), Turkey–Pharmaceuticals: The First WTO Arbitration for Appellate Review, Legal Issues Econ. Integration (2022):

On July 25, 2022, the World Trade Organization issued an arbitration award under Article 25 of the Dispute Settlement Understanding (DSU) on the appeal from the Panel Report in Turkey–Pharmaceuticals. This is the first use of DSU Article 25 arbitration for the review of a WTO panel decision. The successful completion of the arbitration demonstrates that this alternative dispute settlement method can be utilized to fulfill the function of WTO appellate review after the collapse of the Appellate Body. But how did the Arbitrators fare on the substantive legal issues in this case, which concerned a Member’s public health and industrial policies under WTO law? And more importantly, as a systemic matter, how does the appellate review via Article 25 arbitration compare to that by the Appellate Body? This essay provides a critique of the Arbitrators’ findings on the substantive legal issues, while assessing potential advantages of Article 25 appeal arbitration as a long-term solution for the reform of WTO dispute settlement.

December 31, 2022 | Permalink | Comments (0)

Friday, December 30, 2022

Cutting the IDEA's Gordian Knot: Accepting Entanglements of Disability and Self and Embracing a 'Best Interests' Approach to Disciplining Students with Disabilities

Sarah A. Husk (Independent), Cutting the IDEA's Gordian Knot: Accepting Entanglements of Disability and Self and Embracing a 'Best Interests' Approach to Disciplining Students with Disabilities, 51 J.L. & Educ. 86 (2022):

The Individuals with Disabilities Education Act (IDEA) establishes a procedural right and process to protect students with disabilities from punitive disciplinary action where their misconduct is deemed to have stemmed directly from their disability. The manifestation determination review (MDR), in focusing on disability as a discrete, identifiable cause of student (mis)behavior, is oriented around an inquiry that is problematic, inadequate, and ultimately unworkable as a means of effectuating the aims of the IDEA. A central flaw of this assessment framework is that it is predicated on a faulty assumption that disability is (always) severable from a student’s identity, experience, and, ultimately, their behavior or (mis)conduct. This does a profound disservice to students, particularly those with chronic or life-long disabilities who cannot be “cured,” because this approach does not effectively help students develop the emotional and behavioral toolkits they need and deserve to have, and because it can detrimentally undermine young people’s self-concept and lived experience at a critical moment in their development and identity formation.

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December 30, 2022 | Permalink | Comments (0)

Regulatory Cooperation in Vaccines in Asia-Pacific Region

Simon Lacey (University of Adelaide), Andrew D. Mitchell (Monash University), Regulatory Cooperation in Vaccines in Asia-Pacific Region (2022):

This paper explores the massive strides that were made in response to the COVID-19 pandemic by national drug regulatory agencies (NRAs) in order to achieve what ultimately became the fastest incidence in human history of the development, testing, approval, manufacture, and distribution of a new vaccine to an infectious respiratory disease that at the time of writing (April 2022) has by some estimates claimed over 6 million human lives. Our purpose in writing this paper is to highlight what regulators did right, where the pandemic shone a light on gaps, and what can be done by national governments to increase readiness in their NRAs for the next time they are called upon to execute their role in a similar herculean effort.

December 30, 2022 | Permalink | Comments (0)

A New Method for Calculating Potassium Content and Determining Appropriate Potassium Levels in Foods

Abed Forouzesh (University of Tehran), Fatemeh Forouzesh (Islamic Azad University), Sadegh Samadi Foroushani (University of Tehran), Abolfazl Forouzesh (Islamic Azad University), A New Method for Calculating Potassium Content and Determining Appropriate Potassium Levels in Foods (2022):

Calculating the potassium content per 100 kcal, 100 g or 100 mL, or the reference amount customarily consumed (RACC) shows the potassium content of some foods inappropriately. So, making some food choices based on them to achieve adequate potassium intake may increase the risks of some chronic diseases. Calculating the potassium content and determining appropriate potassium levels (to achieve adequate potassium intake) based on U.S. Food and Drug Administration (FDA), Codex Alimentarius Commission (CAC), and the proposed method were performed in 8,192 food items. Making some food choices based on the FDA and CAC per serving (the serving is derived from the RACC) or CAC per 100 g or 100 mL to achieve adequate potassium intake exceeded energy needs, which could lead to overweight or obesity. Making some food choices based on the CAC per 100 kcal or CAC per 100 g or 100 mL to achieve adequate potassium intake did not meet potassium requirements, which could lead to potassium deficiency. Some foods that met potassium requirements were not appropriate food choices based on the CAC per 100 g or 100 mL or CAC per serving to achieve adequate potassium intake. On the basis of the proposed method, calculating the potassium content and determining appropriate potassium levels in foods are performed by considering RACCs and the energy content of foods. Thus, making food choices based on the proposed method met potassium requirements and did not exceed energy needs.

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December 30, 2022 | Permalink | Comments (0)

Thursday, December 29, 2022

The Labor Market Effects of Disability Hiring Quotas

Christiane Szerman (Princeton University), The Labor Market Effects of Disability Hiring Quotas (2022):

People with disabilities are underemployed across the world. With the goal of increasing their representation, more than 100 countries have established quota regulations requiring firms to hire people with disabilities. This paper studies the implications of enforcing modest disability hiring quotas for workers and firms. Using the introduction of a reform in Brazil that enhanced enforcement of a new hiring quota regulation, my market-level analysis finds that people with disabilities in local labor markets more exposed to the reform experienced larger increases in employment and earnings. To explore the margins along which firms respond to the quota scheme, I leverage variation in enforcement across firms. This analysis reveals three key adjustment margins. First, firms tend to comply with the quota by hiring workers with disabilities into low-paying, less skilled jobs. Second, consistent with statistical discrimination, workers with disabilities hired prior to the quota experience reduced wage growth and promotion rates. Third, the quota does not come at a cost to workers without disabilities in terms of wages or employment, or to firms in terms of closure. Using the compliance decision of firms to the quota, I estimate that the marginal worker with disabilities hired under the quota has a marginal revenue product close to their wage. Through the lens of a model of enforcement of hiring quotas with imperfect compliance, I show that the policy generates aggregate welfare gains. My findings demonstrate that, in labor markets under imperfect competition, mandating modest increases in employment for the disadvantaged can promote redistribution and improve welfare.

December 29, 2022 | Permalink | Comments (0)

Tort Liability of Private Safety Auditors in Global Value Chains

Paul Verbruggen (Tilburg University), Tort Liability of Private Safety Auditors in Global Value Chains, 13 Eur. J. of Risk Reg. 4, 584-602 (2022).

Private safety auditors are key constituents of modern risk governance in Global Value Chains (GVCs). However, high-impact safety incidents causing extensive harm in and outside these chains have cast widespread doubts as to the integrity and rigor with which these commercial auditors carry out their professional services. Civil liability has been considered an important legal instrument to incentivize auditors to improve audit accuracy and integrity. Relying on English law, this article assesses to what extent this premise holds true for product safety and social auditing. It studies the liability exposure of private safety auditors for negligent auditing in GVCs. It is argued that this exposure is primarily a function of the contractual obligations these auditors undertake to perform for producers or suppliers in GVCs. This finding draws attention to the need to better understand and define the scope of the safety audits offered for risk management purposes within GVCs.

December 29, 2022 | Permalink | Comments (0)

Food Traceability in Europe, the US and China: Comparative Law and Regulatory Technology

Andrea Stazi (European University of Rome), Riccardo Jovine (European University of Rome), Food Traceability in Europe, the US and China: Comparative Law and Regulatory Technology, BioLaw J. 2 (2022):

The issue of traceability in the food sector lies within the framework of a multiplicity of principles ranging from product identification to data recording, information integration, and accessibility. Traceability responds to a recent need for market and consumer protection which has driven and is still driving policies of major world powers in the food industry and beyond such as the European Union, the United States of America and the People’s Republic of China. In a comparative and multidisciplinary perspective, food regulation poses scientific, economic, legal and technological challenges. Thus, on the one hand, food regulation builds upon the concepts of coexistence, right to know, and precautionary principle. On the other hand, innovation through emerging technologies such as blockchain foreshadows new organizational and regulatory models for a more effective management of traceability systems within the food supply chain.

December 29, 2022 | Permalink | Comments (0)

COVID- 19 Lockdown and Domestic Abuse of Women - Calls for Secured Household and Protection for Women in India

Abhishek Sharma Padmanabhan (CHRIST University), Dr. Sapna S (CHRIST University), COVID- 19 Lockdown and Domestic Abuse of Women - Calls for Secured Household and Protection for Women in India, Indian J. of L. & Legal Res. (2022):

COVID-19 is raising broader problems in terms of human rights, including women's and children's health rights. Women's violence has increased exponentially ever since the outbreak of the Pandemic due to which mandatory lockdown was imposed around the world. The prevalence of social evil, Domestic violence against women has prompted many countries to adopt special policies, rules, and services. However, India, which has not initiated any concrete measures is now experiencing the devastating effects on the lives and liberties of women, wherein the middle- and upper-class women are suffering violence in their homes during the lockdown, and poor women who have no homes or are surviving in slums or on the streets are walking back home or waiting in villages for migrant men to return. According to the National Commission for Women, the number of complaints about women being abused in their homes during lockdown has increased by 94%. The increasing instance of migrant women, along with men, are walking hundreds of miles without food, some of them in advanced stages of pregnancy with their children has received little publicity. During the COVID crisis, women and children are being denied health and other facilities, which is exacerbating the situation, putting nearly half a billion women in India at risk.

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December 29, 2022 | Permalink | Comments (0)

Tuesday, December 27, 2022

The Varieties of Psychedelic Law

Mason Marks (Florida State University, Harvard Law School, Yale University, Leiden University), The Varieties of Psychedelic Law, Neuropharmacology Nat’l Inst. of Health Special Issue on Psilocybin (Forthcoming 2023):

After decades of prohibition, psychedelics are generating intense public and private interest. Scientists are researching the therapeutic properties of these substances, and mounting evidence supports their ability to treat a variety of mental health conditions. Meanwhile, dozens of cities and states are proposing or enacting psychedelics legislation to promote research, increase therapeutic and non-therapeutic access, and decrease criminal penalties associated with producing, possessing, or consuming psychedelics. 

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December 27, 2022 | Permalink | Comments (0)

Health Disparity and Health Equity in India: Understanding the Difference and the Pathways Towards Policy

Sanghmitra Acharya (Jawaharlal Nehru University), Health Disparity and Health Equity in India: Understanding the Difference and the Pathways Towards Policy, 3 CASTE: Global J. on Soc. Exclusion 2, 211-222 (2022):

Health is essential in all spheres of everyday life. It is crucial for well-being, longevity, and for availing economic and social opportunities. Therefore, resources and services needed to be healthy go beyond medical care. Living and working conditions which promote health assume greater importance as they have the potential to reduce the need for medical care. Therefore, the discourse on the health needs to begin from the socioecological framework and move towards the biomedical through the biopsychosocial. The health-promoting elements require to be distributed according to need, rather than treated as commodities which can be accessed based on one’s economic propensity. Pieces of evidence are aplenty that health status is contingent on a health-promoting environment, and imbalances in this environment are likely to produce disparities, inequities and inequalities in health.

December 27, 2022 | Permalink | Comments (0)

Thursday, December 22, 2022

Interconnections Between Religious Hegemony, Socio-Political Processes, & The Mental Wellbeing of Pious LGBT Citizens

Liam Concannon (independent), Interconnections Between Religious Hegemony, Socio-Political Processes, & The Mental Wellbeing of Pious LGBT Citizens (2022):

Religiosity is associated with better mental health outcomes including lower levels of anxiety and depression; a greater sense of emotional wellbeing; and personal fulfilment. However, whether religiosity has the same bearing on the mental health of lesbians, gay men, bisexual, and transgender (LGBT+) individuals has yet to be fully established. What is clear is the social environment in which it operates is one that routinely rejects and stigmatises non-heterosexual people. Set within a global context, religion has been acknowledged to be a key agency hostile to the introduction of legislation protecting the civil rights of the LGBT+ populace. In this article, the interconnections between religious hegemony, LGBT+ Christians, and socio-political advances for the equal rights of gay people is explored through an assessment of the scholarly literature and research. This article seeks to contribute to an understanding of the relationship between traditional religion, secular society, and the mental wellbeing of LGBT+ citizens.

December 22, 2022 | Permalink | Comments (0)

Wednesday, December 21, 2022

Trust Law's Public Policy Doctrine: Major Policy Fault Lines, Aggressive Home Rule Legislation, and Implications for Conflicts Reform

Reid K. Weisbord (Rutgers University), Trust Law's Public Policy Doctrine: Major Policy Fault Lines, Aggressive Home Rule Legislation, and Implications for Conflicts Reform, Tul. L. Rev. (Forthcoming): 

Trust law is highly deferential to settlor intent, however, under the public policy doctrine, any trust or trust provision contrary to public policy is unenforceable. Echoing that doctrine is a conflict of laws rule providing that a settlor’s express choice-of-law designation is enforceable if the trust assets are movable, the designated state has “a substantial relation to the trust,” and “the application of its law does not violate a strong public policy of the state with which, as to the matter at issue, the trust has its most significant relationship.” The conflict of laws rule sets aside choice-of-law designations only when they violate a strong public policy, but trust law’s public policy constraints often inform the determination of conflict of laws disputes. Such disputes have become increasingly common as state laws have diverged on sharply disputed issues such as the validity of self-settled spendthrift trusts, the eligibility of trust settlors and beneficiaries for public benefits, and the enforceability of trustee exculpation provisions.

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December 21, 2022 | Permalink | Comments (0)

Friday, December 9, 2022

Intergenerational Solidarity

Alan Gutterman (Independent), Intergenerational Solidarity (2022):

Aging is a natural progression of the life cycle and society will always have persons of different ages who need to learn to live alongside one another. One of the most consistent themes in the debate regarding the realization of the human rights of older persons is the need to strengthen “intergenerational solidarity” between and among all levels of families, communities and nations in order to achieve social cohesion and a society for all ages and build a foundation of formal public welfare and informal care systems. Proponents of intergenerational solidarity have argued that intergenerational ties can be valuable for everyone and recognizes the significant contributions that older persons make both financially and in providing care and education to younger family members. Intergenerational solidarity can also be important in combatting problems that impact everyone in society, such as climate change. This chapter describes the shared expectations of persons at all stages of the life cycle regarding the aging of individuals and the succession of generations and the creation, allocation and transfer of the resources that are available to support society, the challenges to intergenerational solidarity presented by ageist stereotyping of older persons, the social security systems that provide the legal context for intergenerational solidarity and intergroup contact theory as a tool for forging ties between generations. The chapter also addresses the questions of whether intergenerational solidarity has been an effective strategy for older persons, suggesting that perhaps it would be better for older persons to stop fighting culture wars that have attempted to marginalize them as workers, consumers and citizens and leverage their tremendous clout as consumers and votes to realize their equal rights.

 

December 9, 2022 | Permalink | Comments (0)

An Urgent Call to Integrate the Health Sector into the Post-2020 Global Biodiversity Framework

Simon King (Independent), Chris Lemieux (Wilfrid Laurier University), Melissa Lem (Independent), An Urgent Call to Integrate the Health Sector into the Post-2020 Global Biodiversity Framework (2022):

There is a rapidly closing window of opportunity to stop biodiversity loss and secure the resilience of all life on Earth. In December 2022, Parties to the United Nations (UN) Convention on Biological Diversity (CBD) will meet in Montreal, Canada, to finalize the language and terms of the Post-2020 Global Biodiversity Framework (Post-2020 GBF). The Post-2020 GBF aims to address the shortcomings of the previous Strategic Plan on Biodiversity 2011-2020, by introducing a Theory of Change, that states that biodiversity protection will only be successful if unprecedented, transformative changes are implemented effectively by Parties to the CBD. In this policy perspective we explore the implications of the Theory of Change chosen to underpin the Post-2020 GBF, specifically that broad social transformation is an outcome that requires actors to be specified. We detail how the health sector is uniquely positioned to be an effective actor and ally in support of the implementation of the Post-2020 GBF. Specifically, we highlight how the core competencies and financial and human resources available in the health sector (including unique knowledge, skill sets, experiences, and established trust) provide a compelling, yet mostly untapped opportunity to help create and sustain the enabling conditions necessary to achieve the goals and targets of the framework. While by no means a panacea for the world’s biodiversity problems, we posit that explicitly omitting the health sector from the Post-2020 GBF substantially weakens the global, collective effort to catalyze the trans-formative changes required to safeguard biodiversity.

December 9, 2022 | Permalink | Comments (0)

Sunshine Laws Behind the Clouds: Limited Transparency in a Time of National Emergency

Ira P. Robbins (American University), Sunshine Laws Behind the Clouds: Limited Transparency in a Time of National Emergency, 56 U.C. Davis L. Rev. (2022):

The COVID-19 pandemic dramatically changed the way citizens lived their lives, businesses operated, and governments functioned. With most people forced to stay home, the pandemic also disrupted how people received their news and other essential information. Public records and public meetings had to adapt to face the growing challenges in a locked-down world. While some governmental bodies were able to keep up with the threat that COVID-19 posed against transparency, others either failed to acclimate to the new normal or actively took advantage of the circumstances to limit how much the public knew not only about the crisis, but about other public matters as well.

December 9, 2022 | Permalink | Comments (0)

Overcoming the 'Soft vs Hard Law' Debate in the Development of New Global Health Instruments

Giulia Bosi (Scuola Superiore Sant'Anna),Overcoming the 'Soft vs Hard Law' Debate in the Development of New Global Health Instruments, Opinio Juris (2021):

This contribution begins with a thorough analysis of the use of soft and hard law in the realm of global health law. It then argues that rather than focusing on the a priori debate on which of the two approaches is better suited to tackle global health challenges, in the development of new global health instruments more attention should be paid to: a) how soft and hard law can interact with each other; and b) how to foster respect for the norms, irrespective of whether they are legally binding. In the latter regard, capacity-building, compliance mechanisms and engagement with non-State actors should be given due consideration.

December 9, 2022 | Permalink | Comments (0)

Thursday, December 8, 2022

Timely Dying in Dementia: An Evolving, Binding, Irrevocable Contract to Persuade Physicians to Honor Advance Directives that Request Cessation of Assisted Oral Feeding

Stanley Terman (Caring Advocates or Institute for Strategic Change), Timely Dying in Dementia: An Evolving, Binding, Irrevocable Contract to Persuade Physicians to Honor Advance Directives that Request Cessation of Assisted Oral Feeding (2022):

Background: Using advance directives to avoid prolonged personal suffering and burdening loved ones due to advanced dementia is challenging. Some physicians, their organizations, and others oppose honoring advance directives that request the needed but controversial order, “Cease oral assisted feeding and hydrating.”

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December 8, 2022 | Permalink | Comments (0)