Tag: Health Law

Vial and syringe.

Addressing IP Barriers in the Context of a Pandemic Treaty

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This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Paul Ogendi

Tackling the question of how to address the needs for sharing scientific research, pooling technology, and know-how in diagnostics, therapeutics, and potential vaccines in future epidemics is fundamental to any pandemic treaty discussion. Moreover, we also need to consider how such a treaty might address potential conflicts with the Trade Related Intellectual Property Rights (TRIPS) agreement.

First of all, market-based solutions do not work in the context of global pandemics as has been demonstrated in the COVID-19 pandemic that is currently ravaging the world. Market-based solutions demand putting too much faith in the private sector, both in terms of capacity (supply chains, etc.) and in terms of equity. By relying on the private sector in the context of COVID-19, many countries are struggling to secure adequate personal protective equipment, testing kits, and more importantly life-saving vaccines.

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Illustration of multicolored profiles. An overlay of strings of ones and zeroes is visible

Taking Data Sharing Seriously: Public Interest and Solidarity as Principles for an International Pandemic Treaty

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This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Ciara Staunton and Deborah Mascalzoni

COVID-19 demonstrated the interconnectedness of the world and that our collective protection and well-being is contingent on our individual response. The importance of solidarity and acting in the public interest became key messages in public health, as too were these principles justified as the basis for data-sharing across borders. Accessing this data was critical and its timely access to this data was essential in research for the much-needed new vaccines.

Solidarity can be understood as the commitment to carry costs to assist others. In the same way that we were told to keep away from loved ones (the cost) to stop the spread of the virus (to assist others), individuals were encouraged to share their data with researchers and in turn researchers were encouraged to share their data with other researchers (the cost) to develop vaccines (to assist) for the global collective benefit (others). The response was remarkable. Data sharing became the default (the cost), vaccines were rapidly developed (to assist), but herein the solidarity pathway stopped. Access was (and still is) largely driven by national and private interests rather than the global collective benefit.

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carrot dangling on a string.

International Pandemic Lawmaking: Some Perspectives from Behavioral Economics

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This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Anne Van Aaken and Tomer Broude

In this brief essay, we wish to highlight some insights from behavioral economics that can contribute to a successful process of international pandemic lawmaking. Our interest here is not to engage with individual or collective psychological reactions to pandemics or other large-scale risks, or with substantive policy made in their wake. Several such behavioral issues and dimensions have been dealt with elsewhere, not without (ongoing) spirited debate. For example, the utility of simple reminders to get vaccinated as individual “nudges,” contrasting with enforced vaccination is a continuing issue. Indeed, the WHO is addressing such approaches through the Technical Advisory Group on Behavioural Insights and Sciences for Health, in accordance with general UN behavioral science policy. Similarly, elite decision-makers’ tendencies towards procrastination and omission bias in the face of high degrees of uncertainty, on both national and international levels have arguably negatively impacted large-scale policies with respect to COVID-19. Understanding these and other behavioral dynamics may be crucial in determining the substantive content of a cooperative pandemic regime. Here, however, while building on related frameworks of analysis from the field of behavioral economics, as applied to international law (including nudge theory), our focus is on the process and design of pandemic international law-making.

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FRAND Terms for Pandemic-essential Intellectual Property Rights

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This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Kaat Van Delm

Our international norms are arguably ill adapted to emergencies such as pandemics. In this contribution I discuss a potential remedy for one related challenge, namely, cooperation amongst competitors for the accelerated development of vaccines. A way to foster cooperation could be the use of fair, reasonable and non-discriminatory (“FRAND”) terms to the licensing of pandemic-essential intellectual property rights (IPR). Specifically, states could make participation in public procurement for vaccines by pharmaceutical companies conditional upon accepting FRAND terms for their IPR relevant for vaccine development. I do not suggest changes to the existing rules for allocation of IPR. Rather, I attempt to explore an acceptable limitation of such rights in case of a pandemic. 

Transposing the concept of FRAND terms from standardization to the licensing of pandemic-essential IPR has potential because of the concept’s flexibility. FRAND terms do not require commitment to specific royalties in advance, therefore leaving room for considering new information such as the monetary value of the IPR concerned or the severity of the health crisis.

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Scales of justice and gavel on table.

Limiting Human Rights During Pandemics: Recommendations for Closing Reporting Gaps and Increasing International Oversight

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This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Cassandra Emmons

Sovereign governments have the prerogative to declare states of emergency when sudden, unanticipated events threaten the lives of the nation and its people. In so doing, government decrees sometimes must contradict other international human rights commitments, balancing the individual versus the collective. Established derogation procedures are supposed to ensure such restrictions are proportionate, non-discriminatory, and last only as long as necessary (for an overview, see Emmons 2020). COVID-19 has proven that public health emergencies are not equally recognized in either international law or national constitutions; some international treaties permit “limiting” rights in the name of public health rather than requiring derogation, and nationally some governments authorize emergency measures in practice without ever doing so in name. These parallel processes and conceptual gaps create space for governments to restrict individuals’ rights with little to no international accountability during pandemics.

In this piece, I recommend a new international instrument on pandemic response be explicit about reporting requirements when governments suspend rights during such emergencies. These suggestions incorporate advice from the American Association for the International Commission of Jurists’ Siracusa Principles on the Limitation and Derogation Provisions in the International Covenant on Civil and Political Rights (1985), the International Law Association’s Queensland Guidelines for Bodies Monitoring Respect for Human Rights during States of Emergency (1990), case law of the European Court of Human Rights (ECtHR), and learned experience from the COVID-19 pandemic.

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Globe.

Killing Locally or Killing Globally? Inequalities in Framing Cooperation Through Pandemics

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This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Luciano Bottini Filho

COVID-19 made “pandemic” a buzzword. The world expressed anxiety on the eve of a pandemic declaration from the WHO, a decision monitored as closely as the white smoke for a newly elected pope. Yet, “pandemic” has no legal value in international law by contrast with a declaration of public health emergency of international concern (PHEIC). It is no accident that the 12th Commission of the Institute of International Law issued a report on Epidemics and International Law, which bluntly avoided the term pandemic.

Despite this, for the general public, the role of a PHEIC determination remains unknown. Given the inconsistency in declaring PHEIC (only 6 events between 2007 and 2020), many epidemics of considerable proportion were ignored by the international community. Yet the mismatch in the general public consciousness regarding the legal implications triggered by a WHO declaration of a PHEIC is not as problematic as the way lawyers and public health practitioners reinforce the centrality of a pandemic, a concept that still requires a more solid definition.

As an international instrument potentially moves forward to galvanize “pandemics” as a legally defined term — and part of global health governance — we must understand the implication that this word has in relation to disparities between developing countries‘ problems and the interests of their richer counterparts. After all, any pandemic would have originated from one or more national epidemics, but it would require a globally recognized procedure to trigger stronger international obligations. As opposed to pandemics, though, epidemics have persisted for decades and raged in low- and low-middle income settings from Zika to Ebola, demanding support from international actors.

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A male pharmacist is examining a drug from a pharmacy inventory.

HHS’ New Prescription Drug and Health Care Spending Rule

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By Cathy Zhang

Today, the Department of Health and Human Services — alongside the Department of Labor, the Department of the Treasury, and the Office of Personnel Management — published an interim final rule requiring health insurance plans and issuers on the marketplace to report data on prescription drug and health care spending to the three Departments.

This rule is part of a series of rules issued by the Biden Administration to implement Title I (No Surprises Act) and Title II (Transparency) of the Consolidated Appropriations Act, 2021.

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Globalization concept illustration.

Human Rights and Global Responses to the Pandemic in the Age of Hyper-globalization

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This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Sakiko Fukuda-Parr

In 1999, the Human Development Report called for stronger international arrangements to govern people in a globalized world, stating: “the present era of globalization, driven by competitive global markets, is outpacing the governance of markets and the repercussions on people…. An essential aspect of global governance is responsibility to people – to equity, to justice, and to enlarging the choices of all.” As the 21st century sped into an era of hyper-globalization, new global institutions are urgently needed to protect the public interest. The architecture of global health emergencies is a case in point. Its core agreement, the International Health Regulations (2005) (IHR) remains state centric, catering to national interests, bound to colonial epistemic frameworks, and silent on market power that can trample on human rights. The age of hyper-globalization requires global institutions that enable global – collective – responses to contain pandemics worldwide, that build on international solidarity and human rights norms, and structures that break free from North-South hierarchies of power and knowledge.

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Researcher works at a lab bench

Governance Needs for Pandemic Preparedness and Response: How to Ensure the Science-Policy Interface

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This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Gian Luca Burci

The COVID-19 pandemic has been characterized by mistrust in science, the manipulation of science for political purposes, the “infodemic” of mis- and disinformation, and a repeated failure to base policy decisions on scientific findings.

The crisis of confidence in scientific analysis is paradoxical and disquieting, particularly in light of increasing international regulation to manage acute or systemic risks and its reliance on science.  This so-called “science-policy interface” (SPI) incorporates scientific expertise into global policy-making and regulation in fields as diverse as climate change, biodiversity, and nuclear safety, but it is arguably less developed in global health and in particular for pandemic preparedness and response (PPR).

As international policymakers consider various proposals aimed at preventing another pandemic through better and stronger global rules — whether in the form of a WHO “pandemic treaty,” revised International Health Regulations, a UN political declaration, or regulatory framework — the integration of SPI in their design will be of crucial importance for their credibility and effectiveness.

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Busy Nurse's Station In Modern Hospital

Call Your Senator and Help Give Doctors a Break

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By Jacob Madden

Want to help make a big change for our nation’s overworked doctors? Call your senator and tell them to hire more.

In March of this year, Senators Robert Menendez (D-N.J.), John Boozman (R-Ark.), and Chuck Schumer (D-N.Y.) introduced S.834, the Resident Physician Shortage Reduction Act to confront the country’s growing shortage of doctors.

The proposed legislation will increase the number of resident physician positions supported by Medicare by 2,000 each year from 2023 to 2029, for a total of 14,000 newly supported positions.

This legislation could make a small but significant dent in the nation’s physician shortage. By 2034, the Association of American Medical Colleges expects a shortage ranging from 17,800 to 48,000 primary care physicians, and 21,000 to 77,100 non-primary care physicians. Take both worst-case scenarios, and we are short 125,100 doctors.

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