Atlanta, Georgia - January 28, 2022: US Centers for Disease Control and Prevention (CDC).

Unmasking Public Health

By Jane Moriarty

One of the U.S. Centers for Disease Control and Prevention’s stated “essential public health services” is to “create, champion, and implement policies, plans, and laws that impact health.”

Yet, as the U.S. slogs through its third COVID winter, one thing is clear: personal responsibility and autonomy are at the heart of public health messaging. As CDC director Dr. Rochelle Walensky famously said, “your health is in your hands.”

In other words, CDC and other public health bodies now highlight personal responsibility and autonomy, and minimize the institutional ability to champion policies and laws that would improve the health and safety of the citizenry.

Given the comparatively poor results that the U.S. has had compared to other similarly-situated countries that focus more on the common good, it is time for our public health entities to reinvigorate their role as a force of legal and moral suasion to protect the public’s health.

The moral value of protecting the health of the public should be at the forefront of their messaging. Personal responsibility and autonomy are no match for the reality of commodified and unavailable health care, internet disinformation, health vulnerabilities, age-related vulnerabilities, the lack of paid sick leave, poverty, and the plight of the institutionalized.

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Bill of Health - Globe and vaccine, covid vaccine

Biotech Companies Are Opening Manufacturing Sites in Africa: Will This Help Vaccine Equity?

By Sarah Gabriele

Two pharmaceutical giants of the pandemic, Moderna and BioNTech, are taking steps for increasing the manufacturing capacity for the COVID-19 vaccine in Africa. Last March, Moderna announced its plan to set up a manufacturing facility in Kenya to produce messenger RNA (mRNA) vaccines, including COVID-19 shots. Similarly, in 2021, BioNTech started planning its own manufacturing plant in Africa, which will be composed of modular shipping containers.

Measures to address global vaccine inequity could not come sooner. As of December 15, 2022, only 34% of the population in Africa has received at least one dose of the COVID-19 vaccine, with Moderna and BioNTech having provided fewer doses compared to Oxford-AstraZeneca and Johnson & Johnson. After failing to successfully deliver vaccines equitably during the first two years of the pandemic, Moderna and BioNTech appear now to be taking steps to shoulder greater responsibility for vaccine equity.

However, if companies are ethically required to address the availability of vaccines, these well-intended efforts might still fail to fulfill their moral obligations. Indeed, while the construction of these new sites might sound like great news for fostering the delivery of vaccines in low- and middle-income countries, we should be aware that these manufacturing sites, as well as the existence of manufacturing capacity, might not be enough to achieve desired outcomes.

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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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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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Scales of justice and gavel on table.

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

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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