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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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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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Globe.

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

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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Global connections concept illustration.

21st Century Lawmaking in an Interdependent World

By Caroline E. Foster

A new pandemic instrument should explicitly embrace the three emerging global regulatory standards of due diligence, due regard, and regulatory coherence.

These standards sit at the interface between national and international law to help functionally align the two in ways that will protect and advance shared and competing interests in an interdependent world.

The standards require nations to exercise their regulatory power in certain ways, including demonstrating (i) due regard for the international legal rights and interests of others, (ii) due diligence in the prevention of harm to other States, and (iii) regulatory coherence between governmental measures and their objectives. These international law standards are already implicit in and given effect by the operation of WHO’s current International Health Regulations (IHR) of 2005.

As we develop new pandemic instruments, their presence should be made increasingly explicit. Giving a stronger profile to the standards will help generate new political impetus and new legal bases for implementation of world health law, and fit it to 21st century application.

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Gloved hands hold medical face mask with WHO (World Health Organization) flag.

Strengthening International Legal Authorities to Advance Global Health Security

By Lawrence O. Gostin

The COVID-19 pandemic has exposed marked limitations in the International Health Regulations (IHR) and constrained authorities of the World Health Organization (WHO). With a rising imperative to advance pandemic preparedness and response, more than twenty heads of government proposed a new pandemic treaty. This prospective pandemic treaty offers a pathway to develop innovative international legal obligations, strengthening core capacities, good governance, and compliance mechanisms to prepare for novel outbreaks with pandemic potential.

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international connections concept art.

Moving Beyond a State-Centric Pandemic Preparedness Paradigm: A Call for Action

By Tsung-Ling Lee

Despite the World Health Organization’s (WHO) recent efforts to broaden participation, the international infectious disease control regime remains state-centric.

As such, the state-centric infectious disease regime violates the fundamental principle of how contagious diseases spread within and across countries — the virus recognizes no national borders, nor does the virus discriminate. The longstanding global health mantra — no country is safe until all countries are safe; no one is safe until everyone is safe — should guide global pandemic preparedness.

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Minneapolis, MN / USA - May 26 2020: Black Lives Matter, "I Can't Breathe" Protest for George Floyd.

Expendable Lives and COVID-19

By Matiangai Sirleaf

Two French doctors recently appeared on television and discussed using African subjects in experimental trials for an antidote to the novel coronavirus (COVID-19).

“Shouldn’t we do this study in Africa, where there are no masks, no treatment, no resuscitation, a bit like some studies on AIDS, where among prostitutes, we try things, because they are exposed, and they don’t protect themselves. What do you think?” asked Jean-Paul Mira, head of the intensive care unit at the Cochin Hospital in Paris on April 1, 2020.

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Road sign that reads "Attention Ebola"

Ebola… again: What have we learned?

By Alicia Ely Yamin

As Susan Sontag eloquently noted decades ago, illness conjures metaphors that reveal a great deal about how we think about, and, in turn, address them. None more so than the lethal Ebola, which monstrously disfigures bodies before killing the infected person and spreading rapidly through the routines of everyday life.

In the West, Ebola evokes images of illness as a deadly foreign invasion, while in the West African pandemic we know that first those who were afflicted—and later those who survived—were stigmatized as possessing demons.

The growing outbreak in the DRC has produced calls for greater physical and financial involvement from the US government by a number of health law scholars, citing the potential for exponential spread if it reaches highly populated areas, and underscoring it as a global health security issue.  Thus far, WHO’s Director General has not declared it a “Public Health Emergency of International Concern” (PHEIC), which triggers consideration of both trade and travel restrictions, as well as international assistance and under the International Health Regulations. Read More

Innovation Gaps on Life Science Frontiers

Join us in wonderful Copenhagen at our CeBIL Kick-Off Conference: ”Innovation Gaps on Life Science Frontiers? From Antimicrobial Resistance & the Bad Bugs to New Uses, AI & the Black Box”. The  Conference marks the start of the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law which is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School’s Petrie Flom Center, Harvard Medical School/Brigham & Women’s Hospital, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO).

Leading international experts, including i.a. our distinguished Bill of Health colleagues Glenn Cohen, Aaron Kesselheim; Nicholson Price, and Kevin Outterson, will discuss legal, economic, societal and scientific aspects of selected Life Science areas.

Time: Monday, 5 March 2018 09:00 – 18:00 (followed by a reception in the Gobelin Hall)

Venue: The Ceremonial Hall (Festsalen), University of Copenhagen, Main Building, Frue Plads 4, DK-1168 Copenhagen K

More information on  speakers, agenda and registration is available here and here.

Extended background:

Biomedical innovation is experiencing changes of epic proportions. Rapid progress in many scientific areas, such as gene editing, pharmacogenomics, artificial intelligence and big data-driven precision medicine, has greatly advanced the promises and opportunities of the health and life sciences. Nevertheless, the total number of truly new and innovative drugs receiving market approval is unsatisfactory. At the same time, some of the more innovative therapies that actually could reach patients have become extremely expensive or ethically problematic. These new technological possibilities raise many complex scientific, legal and ethical issues affecting many stakeholders, such as medical practitioners, regulators, patients and the industry.

To support the in depth study of these developments, the Novo Nordisk Foundation has awarded a grant of DKK 35 million for a new Collaborative Research Programme in Biomedical Innovation Law (CeBIL). CeBIL’s overall aim is to help translate ground-breaking biomedical research into affordable and accessible therapies by scrutinizing the most significant legal challenges to biomedical innovation and public health from a holistic cross-disciplinary perspective. CeBIL is hosted by a new Centre for Advanced Studies at the University of Copenhagen’s Faculty of Law. The research is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School, Harvard Medical School, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO). Moreover, CeBIL will collaborate with a broad network of stakeholder organizations and international experts within law, economics, life science, medicine, sociology and pharmacy.

This Kick-Off Conference marks the start of CeBIL which opened its’ doors on January 1st, 2018. Reflecting the research projects that will be at the focus CeBIL’s research during the first 5 years, leading international experts will discuss legal, economic, societal and scientific aspects of selected life science areas and debate future challenges and opportunities.

 

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