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].

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.

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.

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.

3D PRINTED MEDICAL DEVICES: ISSUES FOR PATIENT SAFETY

One consequence of the Covid19 pandemic in 2020 was disrupted supply chains for medical devices. In response, many providers began onsite 3d printing medical devices, without special training or custom tailored instructions. Traditional laws protecting patient safety and tort liability regarding possible malfunction of medical devices are not prepared to address the manufacture of medical devices by enduser health care facilities. The USA Food and Drug Administration (FDA) is one regulatory body that has expressed its desire to validate these uses of 3d printing in emergencies, despite concern about these home-grown devices from the standpoint of patient safety. This article explores the uncharted legal landscape concerning the growing need for national or international regulation addressing 3D printed medical devices in Health care facilities (HCFs) and point of care (POCs) venues. New laws may be needed to protect the integrity of medical products within an overarching duty to protect patient safety. © 2022, William S. Hein & Co., Inc.. All rights reserved.

Failing Forward: How Human Rights Failures in Governments' COVID-19 Responses Can Inform the Development of International Human Rights Law

Despite the pandemic's widespread and transnational impact on human rights, both solidarity and human rights have been side-lined in key intergovernmental discussions on global health law reform to date, while conversations about the development of international human rights law seldom consider global health law's import to the field. This article argues that in spite of states' apparent reluctance to reconcile and harmonise global health law and international human rights law for fairer and more effective public health emergency preparedness and response, international law experts and practitioners are well-placed to indirectly influence normative development in this direction, drawing on their past successes in clarifying and elaborating upon informal international legal standards. Merging strengths from existing legal frameworks of global health law and international human rights law, such expert standard setting efforts can help reimagine a "progressively harmonised" framework of legal regimes for public health emergency preparedness and response. [ FROM AUTHOR] Copyright of International Community Law Review is the property of Brill Academic Publishers and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

International Efforts and Next Steps to Advance COVID-19 Vaccines Research and Production in Low- and Middle-Income Countries.

Equitable and efficient distribution of COVID-19 vaccines continues to be a key issue in global health, and a targeted approach is needed to meet the World Health Organization's world vaccination targets. Although some low- and middle-income countries (LMICs) are developing their own vaccines to address the distribution problem, legal and technical challenges have had a negative impact on productivity. This article explores relevant international legal instruments that can enable faster research and development of COVID-19 vaccines in LMICs, focusing on the role of biosafety standards, biological materials transfer, and key knowledge sharing. Our analysis has established that the potential of existing global health legal instruments has yet to be realized in order to close the productivity gap in LMICs and strengthen their vaccine manufacturing capacity. Additionally, mutual recognition of vaccine efficacy has become a new challenge for achieving global vaccination targets. We argue that the World Health Organization should continue its leading position by developing a more practical and targeted framework to help LMICs overcome challenges arising from technology transfer, knowledge sharing, and politics.

Developing an Innovative Pandemic Treaty to Advance Global Health Security.

Recognizing marked limitations of global health law in the COVID-19 pandemic, a rising number of states are supporting the development of a new pandemic treaty. This prospective treaty has the potential to clarify state obligations for pandemic preparedness and response and strengthen World Health Organization authorities to promote global health security. Examining the essential scope and content of a pandemic treaty, this column analyzes the policymaking processes and substantive authorities necessary to meet this historic moment.

The constitutional economics of the World Health Organization.

This paper brings a constitutional economics perspective to bear on the World Health Organization (WHO), the flagship United Nations intergovernmental health organisation, which is obligated by its Constitution to achieve 'the highest possible level of health' for the world's peoples. The WHO has in the seven decades of its existence used its formidable legislative powers only sparingly. It has been widely chided for being weak in regional coordination and unresponsive to transnational emergencies like the West African Ebola outbreak of 2014-2016. In 2020, it found itself at the centre of the COVID-19 pandemic and in the middle of the Sino-American geopolitical tug-of-war. This paper traces the discordance between the Constitution's stated purposes and the actual track record of the WHO not back to its organisational culture nor to weak leadership but to the design of the Constitution itself. It analytically distinguishes the Constitution's expressive from its instrumental halves, and shows that, whilst the former embodies a 'constitutional moment' of international health solidarity right after the Second World War, the latter embodies a reserved and limited delegation from member-states that are jealous of their sovereignty.