Global Health Technologies are Transforming Intellectual Property and World Trade

The nano-enabled technology of 3-D printing for medical devices presents a dynamic new avenue for meeting patient needs. 3-D printers can generate food, soaps, cosmetics, body parts, metal devices, or medicines. This technology enables continuity of health care delivery despite disruptive breaks in any supply chain due to war, shortage, or broken distribution lines due to pandemic force majeure.1 Featuring custom-tailored attributes for each device, economic efficiency by eliminating transport costs during emergencies, avoiding issues of distribution supply chains, and offering biocompatibility, 3-D printed medical devices during the COVID-19 pandemic2 provided a very attractive alternative to enduring medical supply shortages worldwide. Beyond the covid-19 pandemic exigencies, 3-D printed medical devices promise custom-tailored meals to meet medical needs that are unique for each patient's metabolism and a wide variety of tools for patient care that will change the shape of global commerce.3 3-D printing offers the alluring promise of biocompatible medical devices, matching any patient's unique anatomy, using a specific patient's imaging data, or using a standard design to make multiple identical copies of the same device, but without delays for transport or shipping and insurance costs. The global health impact of these efforts, from the standpoint of patient safety4 and overall deterrence of unnecessary or unsafe medical practices, remains unclear due to the absence of regulation and monitoring. The reality is that commerce can reduce or eliminate transport and storage costs associated with shipping and can change international trade. Yet, 3-D printing simultaneously offers great promise to meet challenges arising from the arcane role of intellectual property rights (IPR)5 in shaping the creation and transfer of nanomedicines and nanotechnologies to attain health equity and meet universal needs of health for all. These millennial technological changes may permanently alter how civil society does business for global health. © 2022, Andover House, Inc.. All rights reserved.

Lodestar in the Time of Coronavirus? Interpreting International Obligations to Realise the Right to Health During the COVID-19 Pandemic

While the right to health has gained significant momentum in international law over the past two years, there is little clarity on what it means for States to comply with this right in times of COVID-19. Taking Articles 2(1) and 12 of the International Covenant on Economic, Social and Cultural Rights as a starting point, our article follows an approach guided by the rules of treaty interpretation under the Vienna Convention on the Law of Treaties to suggest how right to health obligations to prevent, treat and control infectious diseases should be interpreted in relation to COVID-19, and how these obligations interact with general obligations of immediacy, progressive realisation, minimum core and international assistance and cooperation in this context. This article makes a novel contribution to clarifying the right to health during COVID-19, thus enhancing capacity for the oversight of this right;its incorporation in global health law;and the understanding of its corresponding obligations in future global health emergencies. © 2023 The Author(s) [2023].

Lodestar in the Time of Coronavirus? Interpreting International Obligations to Realise the Right to Health During the COVID-19 Pandemic

While the right to health has gained significant momentum in international law over the past two years, there is little clarity on what it means for States to comply with this right in times of COVID-19. Taking Articles 2(1) and 12 of the International Covenant on Economic, Social and Cultural Rights as a starting point, our article follows an approach guided by the rules of treaty interpretation under the Vienna Convention on the Law of Treaties to suggest how right to health obligations to prevent, treat and control infectious diseases should be interpreted in relation to COVID-19, and how these obligations interact with general obligations of immediacy, progressive realisation, minimum core and international assistance and cooperation in this context. This article makes a novel contribution to clarifying the right to health during COVID-19, thus enhancing capacity for the oversight of this right;its incorporation in global health law;and the understanding of its corresponding obligations in future global health emergencies.

The European Health Union and the protection of public health in the European Union: Is the European Union prepared for future cross-border health threats?

The Covid 19 pandemic has cast traditional health protection issues in a new light due to their cross-border significance with far-reaching consequences for almost all areas of social life and places health protection in the European Union in a broader context that goes beyond the national consideration of necessary measures at EU Member State level. The pandemic has made it clear that the responsibility for public health remains in principle with the EU Member States and that the competences of the European Union under Article 168 TFEU are – with a few exceptions – generally limited to supporting, coordinating and assisting tasks. This article examines whether the European Union is adequately prepared for future pandemics and other cross-border health threats based on its responsibilities under the current system of competences between the EU and its Member States in the area of health policy under article 168. The article concludes with some suggestions for discussion and consideration. © 2023, The Author(s).

COVID-19 and the law in Uganda: a case study on development and application of the public health act from 2020 to 2021.

BACKGROUND: Despite the discovery of vaccines, the control, and prevention of Coronavirus disease 2019 (COVID-19) relied on non-pharmaceutical interventions (NPIs). This article describes the development and application of the Public Health Act to implement NPIs for COVID-19 pandemic control in Uganda. METHODS: This is a case study of Uganda's experience with enacting COVID-19 Rules under the Public Health Act Cap. 281. The study assessed how and what Rules were developed, their influence on the outbreak progress, and litigation. The data sources reviewed were applicable laws and policies, Presidential speeches, Cabinet resolutions, statutory instruments, COVID-19 situation reports, and the registry of court cases that contributed to a triangulated analysis. RESULTS: Uganda applied four COVID-19 broad Rules for the period March 2020 to October 2021. The Minister of Health enacted the Rules, which response teams, enforcement agencies, and the general population followed. The Presidential speeches, their expiry period and progress of the pandemic curve led to amendment of the Rules twenty one (21) times. The Uganda Peoples Defense Forces Act No. 7 of 2005, the Public Finance Management Act No. 3 of 2015, and the National Policy for Disaster Preparedness and Management supplemented the enacted COVID-19 Rules. However, these Rules attracted specific litigation due to perceived infringement on certain human rights provisions. CONCLUSIONS: Countries can enact supportive legislation within the course of an outbreak. The balance of enforcing public health interventions and human rights infringements is an important consideration in future. We recommend public sensitization about legislative provisions and reforms to guide public health responses in future outbreaks or pandemics.

Shattering the Mirage: The FDA's Early COVID-19 Pandemic Response Demonstrates a Need for Reform to Restore Agency Credibility.

The power afforded to the administrative state is heavily reliant on public trust and the perception of evidence-based agency decision-making. Organizational reputation is key to preserving regulatory power. However, recent investigations reveal that existing scientific integrity policies may not be sufficient to preserve the credibility of many federal agencies. In fact, a significant number of career scientists across various entities - including the FDA - have observed unreported incidents of political interference. While political influence exerted by the executive branch to set policy goals and determine agency priorities can be beneficial, political pressures must not undermine public trust in scientific agencies. Recently, public perception regarding the FDA's COVID-19 response threatened to weaken the agency's longstanding reputation as the gold standard of review. The COVID-19 pandemic publicized vulnerabilities that exist across agencies, as well as those that are unique to the FDA. The FDA's evolution as an increasingly public health-focused agency that must function in the landscape of politicized science exposes the agency to a greater risk of political interference. After all, the FDA's involvement in public health requires increased participation in non-ideal, value-based decision-making. Throughout its history, the FDA has managed to maintain its reputation through its firm responses to scandal. The COVID-19 pandemic provides a platform for the FDA to - once again - look introspectively and institute safeguards addressing vulnerabilities that plagued the agency's pandemic response. This Article examines the FDA's early COVID-19 response to propose reforms that promote meaningful transparency, public accountability, and scientific integrity.

Logistical challenges with an emphasis on organizing specialized triage in the conditions of a newly emerging, epidemiologically significant infectious pathogen for humans -SARS-CoV2

Background: UMHATEM N.I. Pirogov" Sofia, is one of the largest and busiest hospitals for emergency medical care in Bulgaria. It is the legal successor of the former Institute of Emergency Medicine N.I. Pirogov", and it can be said that at the moment it is the only diagnostic-therapeutic, prophylactic and scientific-educational structure of this type within the Bulgarian healthcare system. The concept of adequate functioning and development of this type of hospital does not consider structuring an Infectious Diseases diagnostic-treatment unit. This reality makes necessary the formation of a radically different organization for the admission and treatment of patients in the hospital, both for those with symptoms of Covid 19 and for all other emergency patients. The organization created in this way must absolutely guarantee safety for both streams of patients. In the conditions of a pandemic, in case of a real threat to public health, the main task of triage in the Emergency Department is to establish indications for urgent hospitalization, or to refuse it in the absence of indications. The characteristic course of the disease, the prolonged treatment, the manifestations within the so-called post-Covid syndrome", require serious planning not only of the diagnostic-treatment and rehabilitation period, but also adequate monitoring in the first months after the patient's discharge. Within the national reorganization measures, during the determined periods, the main changes concerning the MED (Multi-profile emergency department) of Pirogov are implemented, with an emphasis on the formation of a specialized triage for the diagnosis and clinical evaluation of patients with a coronavirus infection. The main goal is the adequate diagnosis, treatment and follow-up of patients with coronavirus infection who have passed through the organized Covid-triage in a period of extreme pressure on the emergency structures and on the hospital system in the country as a whole. Objective(s): For a MED, which at the time of declaring an epidemic situation does not have a concept for the diagnosis and treatment of infectious diseases, to systematize the main urgently implemented organizational and structural changes, which turned out to be absolutely necessary to meet a newly emerging epidemiologically significant infectious disease. Aim(s): To systematize the organizational changes imposed by the situation and urgently implemented in the MED (multi-profile emergency department). To systematize the structural changes imposed by the situation and urgently implemented in the work of the MED. To analyze the organizational and structural changes carried out in this way and to differentiate the main difficulties caused by the regulations existing at the time of the announcement of the epidemic situationCopyright © Pantileeva D et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC-BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

Locating Disability Within a Health Justice Framework.

This Article explores the connections between disability and health justice in service of further tethering the two theories and practices. The author contends that disability should shift from marker of health inequity alone to critical demographic in the analytical and practical application of health justice. This theoretical move creates a more robust understanding of the harms of health injustice, its complexities, and, remedially, reveals underexplored legal and policy pathways to promote health justice.

Antimicrobial Resistance Must Be Included in the Pandemic Instrament to Ensure Future Global Pandemic Readiness.

Governments can practically and efficiently address zoonoses and AMR -- within the text of the new pandemic instrument. We map the overlaps between the efforts needed to address both pandemic threats, including (a) equitable access to medical countermeasures, (b) globally integrated One Health surveillance and monitoring systems, (c) increased technical and laboratory capacity in low- and middle-income countries, and (d) a regulatory framework governing the stewardship of antimicrobials. By outlining potential dual-purpose provisions that could be included in a pandemic instrument, we argue that addressing AMR in the pandemic instrument is practicable, the most effective use of limited time and resources, and provides the best opportunity for future global pandemic readiness.

Embed Multisectoral Governance Mechanisms in the Pandemic Instrument for One Health Action.

Despite recognition of the health threat posed at the human-animal-environment interface long ago, One Health has yet to be meaningfully integrated into global pandemic prevention, preparedness, and response. With the negotiation of the forthcoming pandemic instrument under the auspices of the World Health Organization (WHO) - which is inherently restricted by its own constitutional mandate of human health - One Health risks being sidelined once again. Genuine integration of a One Health approach into this treaty will require the institutionalization of formal One Health coordination mechanisms.

Introduction: AMR Belongs in the Pandemic Instrument.

In the wake of COVID-19, the World Health Organization established an Intergovernmental Negotiating Body to negotiate a new instrument for pandemic prevention, preparedness, and response. This special issue of the Journal of Law, Medicine & Ethics brings together multidisciplinary scholarship to address the question of whether antimicrobial resistance should be included in this new instrument. Drawing from disciplines including law, anthropology, history, public health, public policy, economics, and veterinary medicine, this special issue explores the inclusion of AMR within the Pandemic Instrument from three perspectives: first, through the lens of global AMR governance, second, from the perspective of technical governance challenges and opportunities affecting the global ability to address AMR and future pandemics, and third, from the perspective of pandemic instrument mechanisms for strengthening global AMR governance. Each paper makes a concrete recommendation with respect to the importance of including AMR within the scope of the pandemic instrument.

COVID-19 Law Lab: Building Strong Legal Evidence.

The COVID-19 Law Lab platform enables quantitative representation of epidemic law and policies in a given country for multiple years, enabling governments and researchers to compare countries, and learn about the impacts and drivers of policy choices. The Law Lab initiative is designed to address the urgent need for quality legal information to support the study of how law and policy can be used to effectively manage this, and future, pandemic(s).

The COVID-19 vaccine patent: a right without rationale.

Since the approval of COVID-19 vaccines, international efforts have intensified on vaccination schemes perceived as the only light at the end of the tunnel. Governments are working tirelessly to scale up the number of vaccinated people, just as vaccine manufacturers are stretching their facilities to meet the increasing demand for doses. The international community is trying to help the poorest countries in the world by improving vaccine supplies and removing obstacles. In this regard, India and South Africa have applied to World Trade Organisation to waive vaccine-related intellectual property rights. The proposal has sparked off academic debates as to its merit. This article addresses the waiver controversy. Following a critical review of both dimensions of the controversy, the article concentrates on the extent to which the waiver application contradicts the theoretical justification of the patent system. It concludes that the concerns raised over the conflict between the waiver proposal and the patent right philosophy are indefensible.

Global law, policy, and governance for effective prevention and control of COVID-19: A comparative analysis of the law and policy of Pakistan, China, and Russia.

Global health governance is a developing system in this complex institutional regime. The local and regional health policies sometimes challenge global health governance due to diverse discourse in various countries. In the wake of COVID-19, global health governance was reaffirmed as indifferent modules to control and eliminate the pandemic; however, the global agencies later dissected their own opinion and said that "countries must learn to live with a pandemic." Given the controversial statement, this research focuses on the strong and effective policies of the Russian Federation, Pakistan, and China. The research uses the law and governance results and newly developed policies of the three countries formed under the global health policies. The conclusion is based on the statement that in order to live with the pandemic, strong health measures are required at each level.

Impact of mandatory COVID-19 shelter-in-place order on controlled substance use among rural versus urban communities in the United States.

PURPOSE: Mandatory COVID-19 shelter-in-place (SIP) orders have been imposed to fight the pandemic. They may also have led to unintended consequences of increased use of controlled substances especially among rural communities due to increased social isolation. Using the data from the American Association of Poison Control Centers, this study tests the hypothesis that the poison control centers received higher rates of calls related to exposures to controlled substances from rural counties than they did from urban counties during the SIP period. METHODS: Call counts received by the poison control centers between October 19, 2019 and July 6, 2020 due to exposure to controlled substance (methamphetamine, opioids, cocaine, benzodiazepines, and other narcotics) were aggregated to per-county-per-month-per-10,000 population exposure rates. A falsification test was conducted to reduce the possibility of spurious correlations. FINDINGS: During the study period, 2,649 counties in the United States had mandatory SIP orders. The rate of calls reporting exposure to any of the aforementioned controlled substances among the rural counties was higher (14%; P = .047) relative to the urban counties. This overall increase was due to increases in the rates of calls reporting exposure to opioids (26%; P = .017) and methamphetamine (39%; P = .077). Moreover, the rate of calls reporting exposures at home was also higher among the rural counties (14%; P = .069). CONCLUSION: The mandatory SIP orders may have had an unintended consequence of exacerbating the use of controlled substances at home in rural communities relative to urban communities.

Facilitating the Urgent Public Health Need to Improve Data Sharing With Tribal Epidemiology Centers.

Tribal epidemiology centers (TECs) are an essential and unique part of the public health system and an important part of federal efforts to improve the health status of American Indian and Alaska Native people. Pursuant to federal statute, TECs serve the 574 federally recognized tribes (hereinafter, "tribes") and their members across the United States, as well as American Indian and Alaska Native people in general. The COVID-19 pandemic has highlighted the need for timely, complete, and accurate public health data, particularly for American Indian and Alaska Native communities and others who may have been disproportionately impacted by COVID-19. This article reviews the history and importance of TECs and federal statutes governing TECs' ability to access and use protected health information for public health purposes. TECs and tribes often encounter difficulty receiving public health data from state and federal agencies despite their designation as "public health authorities" under the Health Insurance Portability and Accountability Act and associated regulations. Limited access to this information hinders the statutory mission of TECs as well as tribal monitoring of and response to public health threats such as SARS-CoV-2. Agency acknowledgment and compliance with current federal law regarding data sharing with TECs are essential to improve data access and the fragile public health of tribal communities.

Studying Public Health Law: Principles, Politics, and Populations as Patients

Public health law is firmly establishing itself as a crucial area of scholarly inquiry. Its vital importance has been sharply underscored following the outbreak of COVID-19, in response to which we have seen the institution of extreme legal measures—such as the UK's Coronavirus Act 2020—in efforts to control and contain the spread of the disease. The pandemic has also starkly exposed the complex nature of the regulatory challenges, nationally, internationally, and globally, to which such public health problems give rise. In approaching these, and other questions concerning the public's health, such as non-communicable disease, public health law, as a field, brings notable distinctive features: these include a practical focus on populations, institutions, the prevention of ill health, protection of good health, and the promotion of positive states of well-being;and concomitant critical approaches rooted in theories of social justice as contrasted with more narrow biomedical ethics. Such features make it in some senses atypical territory within the field of health law. Furthermore, the inherent role of political institutions places law conceptually within public health in a way that may be seen as distinguishable from law's relationship with clinical medicine. This chapter explains how the broad reach and distinct features of public health require a commensurately broad approach to conceptualising public health law, and how distinct practical and theoretical features may be integrated into academic public health law. It also shows how public health law, with its distinct conceptualisations concerning ‘the body' of medical jurisprudence, can both challenge and enrich medico-legal studies, and bring important perspectives within the broader field of health law. © 2020, The Author(s).

The legal determinants of health (in)justice.

The mutual influences of social epidemiology and ideas of justice, each on the other, have been seminal in the development of public health ethics and law over the past two decades, and to the prominence that these fields give to health inequalities and the social-including commercial, political, and legal-determinants of health. General and political recognition of injustices in systematised health inequalities have further increased given the crushingly unequal impacts of the COVID-19 pandemic; including impacts of the legal and policy responses to it. However, despite apparent attention from successive UK governments to injustices concerning avoidable inequalities in health opportunities and outcomes, significant challenges impede the creation of health laws and policy that are both effective and ethically rigorous. This article critically explores these points. It addresses deficiencies in a UK health law landscape where health care contexts and medico-ethical assumptions predominate, to the great exclusion of broader social and governmental influences on health. The article explains how a public health framing better serves analysis, and engages with a framework of justice-oriented questions that must be asked if we are to understand the proper place and roles of law and regulation for the public's health.

A Global Pandemic Treaty Must Address Antimicrobial Resistance.

Antimicrobial resistance (AMR) is one of the defining global health threats of our time, but no international legal instrument currently offers the framework and mechanisms needed to address it. Fortunately, the actions needed to address AMR have considerable overlap with the actions needed to confront other pandemic threats.

[Mental health law in Argentina]

This article reviews important issues in relation to mental health in Argentina. In the first place, its situation in the country and the recommendations of the World Health Organization in reference to the fact that, in low- and middle-income countries, more than 75% of people with mental, neurological and substance use disorders do not receive any treatment. Human resources in Argentina and its comparison with other countries are reviewed. Emphasis is placed on the need for trained primary care services in mental health and to improve the organization of health systems and services. Reference is also made to the Mental Health Law 26657 enacted in 2010, and the problems that have led to it not yet being fully implemented, the debate about this law, and the current claim of family members for the lack of response to their needs, and therefore the importance of its implementation. Finally, the effects of the COVID pandemic on the mental health of the general population are exposed.