Image of a pile of contraceptive pills.

The Contraceptive Coverage Mandate Is Urgently Needed

By Gregory Curfman

Within the coming months, the constitutional right to abortion, which has been in place for nearly 50 years, is likely to be overturned.

In this light, it is more crucial than ever that women have unfettered access to contraception at no charge. Accordingly, the Biden Administration should act now to return the Affordable Care Act’s (ACA) contraceptive coverage mandate to its status originally intended by Congress in 2010.

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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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David Tolley headshot

Meet David Tolley, Petrie-Flom Center Advisory Board Member

The Petrie-Flom Center is excited to welcome David Tolley to our Advisory Board!

Tolley is a Partner at Latham & Watkins LLP and is the chair of the Litigation & Trial Department for the firm’s Boston office. He represents health care organizations in high stakes matters, including government investigations and litigation. Tolley has also worked on pro bono litigation with the Center for Health Law Policy Innovation at Harvard Law School to help secure access to life-saving therapies for people with hepatitis C.

To learn more about the depth of experience that Tolley will bring to the Advisory Board, we asked him a few questions about his background and current areas of practice. The interview, which has been edited and condensed, follows.

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Vial and syringe.

Causes of COVID Vaccine Hesitancy

By Jasper L. Tran

Vaccinated individuals — like Tolstoy’s happy families — are all alike; each unvaccinated individual is hesitant for her own reason.

Prior research conducted in developed countries reveals five main individual-level determinants of pre-COVID vaccine hesitancy (commonly referred to as the 5 C model drivers of vaccine hesitancy): (1) Confidence (trust in vaccine’s effectiveness and safety, vaccine administrators and their motives); (2) Complacency (perceiving infection risks as low and vaccination as unnecessary); (3) Convenience / Constraints (structural or psychological barriers to converting vaccination intentions into vaccine uptake); (4) Risk Calculation (perceiving higher risks related to vaccination than the infection itself); and (5) Collective Responsibility (willingness to vaccinate to protect others through herd immunity).

COVID-19 vaccines see these five hesitancy determinants again, only further exacerbated by waves of misinformation promulgated on social media, including through “bot” accounts, that prey on the concerns and insecurities of an already vulnerable public.

On the one hand, irrational and unreasonable conspiracy theories about COVID-19 and its vaccine abound among the anti-vaxxers — a subgroup of science deniers. These conspiracy theories include:

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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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Globalization concept illustration.

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

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

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

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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Checklist.

Casualties of Preparedness: Rethinking the Global Health Security Paradigm

By Manjari Mahajan

The calls for a new pandemic treaty, like the genesis of the International Health Regulations (IHR), have been anchored within a paradigm of “global health security.” Before undertaking new projects of international lawmaking, it behooves us to examine this dominant paradigm and assess whether it actually leads to the goal of pandemic preparedness across countries. At stake are the future contours of a global normative, legal and infrastructural machinery and whether its animating logics are historically informed, evidence-driven, and geographically equitable.

The prevailing global health security paradigm was institutionalized in international law through the IHR, a policy centerpiece that was most recently revised in 2005 in response to a series of new infectious diseases including AIDS, SARS, and Ebola. At its foundation, the schema identifies the problem at hand as outbreaks of emerging infectious diseases, which become global security threats as they travel across borders. The focus is very much on new and re-emerging infectious diseases, and not ongoing health-related problems in a population. Moreover, this framework is animated by a special anxiety about contagion from poorer, purportedly primordial and volatile countries in the global South to the North.

The emphases on new infections and preventing their travel from the South to the North have resulted in a politics of control and enforcement that carry with it particular normative and infrastructural demands.

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