Bill of Health - Globe and vaccine, covid vaccine

Reclaiming Global Public Health

By Zain Rizvi

By December 2020, the world had astonishingly powerful tools against COVID-19. New mRNA vaccines, underpinned by decades of public investment, had been authorized by global regulators. Yet the promise of the vaccines was unevenly realized: deep fault lines emerged between those who were able to secure vaccines and those left behind, or what South Africa’s president Cyril Ramaphosa called “vaccine apartheid.”

Dose shortages elevated the role of pharmaceutical executives. Fielding calls from heads of state, they decided what vaccine deliveries to prioritize, shaping which countries could protect lives and livelihoods. The answer to one of the most important public health questions of our time — who gets access to vaccines? — was mostly determined neither by political representatives nor scientists, but by corporate executives.

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Traffic light.

The COVID-19 Pandemic, the Failure of the Binary PHEIC Declaration System, and the Need for Reform

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

By Ilja Richard Pavone

The COVID-19 pandemic has raised unprecedented challenges for the global health framework and its long-term consequences are not yet in full sight. The legal and institutional regime aimed at preventing and controlling the spread of infectious diseases, grounded on the International Health Regulations (IHR) was heavily criticized.

The alarm mechanism based on the declaration of Public Health Emergency of International Concern (PHEIC), in particular, has been severely tested. A PHEIC is an extraordinary event that constitutes a potential public health risk through the international spread of a disease outbreak. The WHO Director-General bases his decision to “ring the bell” upon the technical advice of an Emergency Committee (EC) carrying out “an assessment of the risk to human health, of the risk of international spread, and of the risk of interference with international traffic.”

A PHEIC, then, is declared only when an event is already sufficiently acute and has started to spread internationally. It is not an early warning, but a formal alert, and in the case of COVID-19 it was issued with extreme delay only on 30 January 2020, (one month after notification of early cases by the Chinese government), after Beijing had already adopted quarantine measures around the city of Wuhan, and draconian measures to curb the spread of the disease in the country had been announced.

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The Mexican-American border, with some construction still ongoing on the American side.

Pandemics without Borders? Reconsidering Territoriality in Pandemic Preparedness and Response Instruments

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

By Raphael Oidtmann

The COVID-19 pandemic has (yet again) disclosed that, in contemporary international law, the notion of borders resembles a distinct emanation of legal fiction, i.e., “something assumed in law to be fact irrespective of the truth or accuracy of that assumption.” This characterization of international borders holds particularly true with a view towards managing, containing, and countering the spread of highly contagious pathogens: especially in the context of responding to the global COVID-19 pandemic, it has hence become apparent that the traditional conception of borders as physical frontiers has been rendered somewhat moot. On the contrary, the pandemic experience has proven that a more flexible, fluid, and functional understanding of (international) borders might be warranted, also with a view towards (re-)conceptualizing international health law.

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Geneva, Switzerland - December 03, 2019: World Health Organization (WHO / OMS).

Towards Member-driven International Pandemic Lawmaking

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

By Ching-Fu Lin and Chuan-Feng Wu

The COVID-19 pandemic has blatantly exposed the flaws of the World Health Organization (WHO) and its International Health Regulations (IHR) in addressing cross-border communicable diseases. Commentators have examined the IHR’s decades of struggle in fulfilling its objectives to control cross-border pandemics such as COVID-19, pointing out problems over the level of obligation, precision of language, delegation of power, settlement of dispute, and lack of enforcement power, among others. What has been overlooked, however, is the crucial question of whether the institutional design of the IHR enables the WHO and its Member States to deliver good global pandemic governance.

We argue that the IHR is ill-designed: its rules and mechanisms are disproportionately tied to the Director General’s (DG) exercise of power, rendering insufficient member access to and participation in core decision-making and greater tendency of regulatory capture. For example, the IHR failed to facilitate the timely declaration of a Public Health Emergency of International Concern (PHEIC) due to the DG’s and the Emergency Committee’s misinterpretation and misapplication of rules allegedly driven by political considerations. On 23 January 2020, even when COVID-19 cases had already been found outside of China, thereby indicating the risk of cross-border transmission (IHR Article 12(4)(e)), the second meeting of the Emergency Committee decided to confine the definition of “international spread” to “having actual local spread of COVID-19 in a country beyond China,” instead of “having the potential for, or a risk of, cross-border transmission,” and refused to declare a PHEIC. The WHO is also criticized for abusing its bureaucratic influences to further the agendas of individual Member States like China, letting politics override science.

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Society or population, social diversity. Flat cartoon vector illustration.

The Right to Participation in Global Health Governance: Lessons Learned

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

By Sara (Meg) Davis, Mike Podmore, and Courtenay Howe

What should the role of those most affected by pandemics be in future pandemic governance and co-ordination mechanisms?

Drawing on human rights standards and principles, and on existing structures in the HIV, TB and malaria sectors, we argue that the human right to participation should extend to permanent seats and votes for civil society and affected communities on governance boards.* Our argument is informed by an analysis by STOPAIDS, Aidsfonds, CSSN and Frontline AIDS, by consultations led by STOPAIDS, and by the examples of the Global Fund to Fight AIDS, TB and Malaria (“the Global Fund”), Unitaid, and the Access to Covid Technologies-Accelerator (ACT-A).

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Linking entities.

A Shared Responsibility Model

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

By Sharon Bassan

Piecemeal and fragmented policymaking during COVID-19 underscored the need for an equity-focused global health agenda. Several international health law mechanisms, such as the International Health Regulations (IHR) and “soft law” frameworks, try to bring together relevant stakeholders to the table, help ensure international sharing of medical information, and facilitate equitable distribution of the benefits of research in developing vaccines and therapeutics. Nevertheless, their application during COVID-19 did not result in an effective global governance. Most responses were nationally-focused, lacked global commitment and solidarity, failed to notify the WHO of novel outbreaks, and were non-compliant with its professional recommendations.

Many agree that the solution should be multileveled and structural­ — a result of the connection and cooperation between participants. The prism of the “shared responsibility model” provides an interesting opportunity to consider potential global health governance models for emergency actions. My refined version of the model is based on Iris Young and Christian Barry’s suggested models, and includes two pairs of parameters, engaging and assigning. Engaging parameters locate the involved actors, and explain why they are assigned responsibilities. Assigning parameters address the type of duties each actor bears, and the site where they are expected to take action.

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Vial and syringe.

Addressing IP Barriers in the Context of a Pandemic Treaty

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

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

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

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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