Gloved hand holding medical rapid test labeled COVID-19 over sheet of paper listing the test result as negative.

Federal COVID-19 Response Unlawfully Blocks State Public Health Efforts

By Barbara J. Evans and Ellen Wright Clayton

The federal government recently used preemption unlawfully to prevent state public health efforts to protect vulnerable people from COVID-19.

As 1,000 current and former CDC epidemiologists noted in an open letter, the federal government has failed to use legal powers it does have to manage the crisis, leaving states to “invent their own differing systems” to manage COVID-19. We add that the federal government is now asserting emergency powers it does not have to disable state public health responses.

Early this month, Nevada officials halted the use of two rapid coronavirus tests that produced high false-positive rates when used for screening vulnerable people in Nevada’s nursing homes, assisted-living, long-term care, and other congregate facilities. More than half the positive test results were false.

On October 8, the U.S. Department of Health and Human Services (HHS) sent a letter threatening that the Nevada officials’ action was “inconsistent with and preempted by federal law and, as such, must cease immediately or appropriate action will be taken against those involved.” Nevada yielded to this threat and, on October 9, removed its directive to stop using the tests.

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Vaccine.

Compulsory Licensing for Pharmaceuticals in the EU: A Reality Check

By Caranina (Nina) Colpaert

As pharma races to develop a COVID-19 vaccine, researchers and governments are working in parallel to pinpoint strategies to secure its widespread access.

To that end, many countries plan to seek refuge in a long-existing strategy: compulsory licensing.

In the European Union (EU), however, compulsory licensing is not as self-evident as it might seem. This blog post focuses on four specific challenges that come with compulsory licensing in the EU and potential alternative solutions.

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Researcher works at a lab bench

Deconstructing Moderna’s COVID-19 Patent Pledge

By Jorge L. Contreras, JD

On October 8, Cambridge-based biotech company Moderna, Inc., a leading contender in the race to develop a COVID-19 vaccine, publicly pledged not to enforce its COVID-19 related patents against “those making vaccines intended to combat the pandemic.”

It also expressed willingness to license its intellectual property for COVID-19 vaccines to others after the pandemic. In making this pledge, Moderna refers to its “special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.”

Moderna holds seven issued U.S. patents covering aspects of an mRNA-based candidate vaccine directed to COVID-19 which entered Phase III clinical trials in July. The potential market for a COVID-19 vaccine is potentially enormous. As of this writing, the U.S. government has committed approximately $1.5 billion to acquire 100 million doses of Moderna’s vaccine if it proves to be safe and effective (with an option for 100 million more), and the Canadian government has agreed to purchase 20 million doses for an undisclosed amount.

In the high-stakes market for COVID-19 vaccines, it is worth considering the full range of factors that might motivate a private firm to relinquish valuable intellectual property rights for the public good. A better understanding of these factors could help policymakers to secure additional pledges from firms that have not yet volunteered their intellectual property in the fight against the pandemic.

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doctor holding clipboard.

A Critical Race Perspective on Social Risk Targeting in the Health Care Sector

By Brietta R. Clark

Health care programs, such as Medicaid, are increasingly using social risk assessments to target certain patients or communities for interventions intended to promote health. This includes partnering with other service sectors to provide nutrition, housing or employment assistance, transportation, parenting education, care coordination, and other behavioral supports.

These social interventions are touted as a way to improve health equity, yet they do not address structural racism, a powerful determinant of health. These interventions tend not to measure racial impact, or account for how racial inequity shapes the very structures and systems upon which social interventions depend. Indeed, this inattention means that such well-meaning interventions may inadvertently reinforce racial inequity, subordination, and stigma in marginalized communities.

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Supreme Court of Mexico.

How Does the Mexican Constitution Regulate Crisis?

By David García Sarubbi

When the Mexican Constitution was issued in 1917, one of its main concerns was to regulate how democracy must deal with crisis, that is, with exceptional situations that demand the exercise of powers outside the Constitution’s regular limits to suppress potential dangers.

There is not an “off switch” available for political powers to put the Constitution to rest while solving urgent issues. Instead, there are complex rules to govern decisions in extraordinary circumstances.

The Constitution’s Article 29 has a Suspension Clause, which contains a detailed regulation for such cases. Moreover, in Article 73, Section XVI, there is another regulation relating to pandemics like the one we are experiencing currently.

Thus, from the founding era, the Mexican constitution has upheld the value of the rule of law, even in extraordinary circumstances.

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Protestor holding sign that reads: "we need reform now."

Using Anti-Racist Policy to Promote the Good Governance of Necessities

By Aysha Pamukcu and Angela P. Harris

Multiple crises creating a “wet cement” moment

In the U.S., racism has repeatedly stymied progress toward the good governance of necessities. Anti-racism, therefore, must be at the core of solutions to our present crises.

One of the most powerful applications of anti-racism is through policy. By enacting and enforcing anti-racist policy, we can govern more of life’s necessities as public goods.

Achieving this requires a robust coalition of advocates who are organized, interdisciplinary, and prepared to promote the equitable governance of vital goods. The “civil rights of health” — a partnership of civil rights, public health, and social justice advocates — can help provide the change infrastructure needed for this paradigm shift.

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abortion protest outside supreme court.

Abortion and the Law in America: Video Preview with Mary Ziegler

The Health Law Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts.

The workshop is led by Professor I. Glenn Cohen, and presenters come from a wide range of disciplines and departments.

In this video, Mary Ziegler gives a preview of her paper, “Abortion and the Law in America: Roe v. Wade to the Present,” which she will present at the Health Law Policy workshop on October 19, 2020. Watch the full video below:

Up close shot of an orange prison jumpsuit

COVID-19 and Women in the US Criminal Legal System

By Cynthia Golembeski, Carolyn Sufrin, Brie Williams, Precious Bedell, Sherry Glied, Ingrid Binswanger, Donna Hylton, Tyler Winkelman, and Jaimie Meyer

Health and economic inequities exacerbated by the COVID-19 pandemic disproportionately harm women, and particularly women of color, involved in the criminal legal system.

Structural racism, sexism, poverty, substandard healthcare in jails and prisons, and the health effects of incarceration worsen women’s health. The pandemic only compounds these effects. Often overlooked or less visible, incarcerated women are at significantly increased risk of acquiring infectious illness, including COVID-19.

Alternatives to incarceration, and care continuity for chronic health conditions, including substance-use and psychiatric disorders, which disproportionately affect women, are necessary within the current pandemic and beyond.

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Young male doctor in telehealth concept

COVID-19’s Impact on Clinical Trials: Meeting Participants Where They Are

By Sarah V. Ferranti and Shine Chen Schattgen

“Decentralized” clinical trials (referred to as “DCTs”) are not novel, but nevertheless failed to gain real momentum given the regulatory and operational complexities involved. In light of COVID-19, however, it seems almost certain that the remote and virtual study activities that characterize DCTs, and a site and sponsor’s ability to flex to “meet the participant where they are” will be critical to the conduct of clinical trials going forward.

In the first half of 2020, as health care facilities prepared for capacity-exceeding patient volumes and equipment shortages, non-essential clinical care and non-COVID-related clinical trials came to a screeching halt. According to ClinicalTrials.gov, 1473 clinical trials were suspended, terminated, or withdrawn between December 1, 2019 and July 1, 2020, with a reported reason that explicitly mentioned COVID-19.

At the same time, initiation of clinical trials for COVID-19 vaccines and treatments exploded at speeds previously considered unachievable within the clinical trial industry. As of October 13, 2020, 811 COVID-19-related clinical trials had been initiated in the United States. To enable COVID-19 trials and, more recently, to restart previously paused non-COVID trials, clinical trial sponsors and sites have been forced to quickly adapt to protect participants and preserve the integrity of clinical trial data and results.

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