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.

Read More

a pill in place of a model globe

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of August. The selections feature topics ranging from a commentary on the need for rigorous scientific evaluation of COVID-19 vaccine candidates in the face of political and economic pressures, to an evaluation of patients’ and pharmacists’ experiences with pill appearance changes, to an examination of the extent and cost of potentially inappropriate prescription drug prescriptions for older adults. A full posting of abstracts/summaries of these articles may be found on our website.

Read More

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.

Read More

Social distancing concept image.

Democratizing the Law of Social Distancing: Video Preview with Lindsay F. Wiley

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, Lindsay F. Wiley gives a preview of her paper “Democratizing the Law of Social Distancing,” which she presented at the Health Law Policy workshop on September 14, 2020. Watch the full video below:

Syringe and vials of vaccine.

Racial Inclusivity in COVID-19 Vaccine Trials

By Colleen Campbell

Recent calls for racial inclusivity in vaccine trials, which often rely on genetic rationales while emphasizing medical distrust among African Americans, unfortunately lack an equally robust critique of medical racism and the ongoing reasons for this distrust.

Even though race lacks genetic meaning, the COVID-19 discourse is rife with biological notions of race. Because of [g]enetics related to racial differences” African Americans must be involved in clinical trials, said Dr. Larry Graham in an NBC News article. He continued: “We must be sure it works in Black folks.” For this reason, companies like biotech firm Moderna are enlisting Black religious leaders to heavily recruit African American participants. They are also exploiting networks previously used for HIV clinical trials.

Read More

Valuing the vaccine still.

Valuing the Vaccine: Video Preview with Lisa Ouellette

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, Lisa Ouellette gives a preview of her paper “Valuing the Vaccine,” co-authored by Daniel J. Hemel, which they will present at the Health Law Policy workshop on September 21, 2020. Watch the full video below:

Syringe and vials of vaccine.

Why a COVID-19 Vaccine Shouldn’t be Mandatory

By Dorit Rubinstein Reiss and Y. Tony Yang

A future COVID-19 vaccine will not work without sufficient uptake, and some are considering mandates to get that uptake. Some scholars have gone so far as to call for compulsory vaccination for all U.S. residents in a recent USA Today column.

We believe premature mandates won’t work. In fact, they could backfire spectacularly.

There are several reasons for this. First, once we have an approved vaccine, we will not have enough doses to go around for those who want them. Forget mandates: even if all goes remarkably well, we will begin by producing and distributing tens of millions of doses—not the hundreds of millions needed to cover the entire United States.

Read More

Money.

Conflicts of Interest in the Hospital Sector: A Q&A with Rina K. Spence

By Chloe Reichel

Brigham and Women’s Hospital recently made headlines when the Boston Globe reported that the hospital’s president, Dr. Elizabeth Nabel, held a seat on the board of Moderna, a Cambridge biotech company that is working to develop an mRNA COVID-19 vaccine. The hospital has a major role in a national study of the vaccine.

The hospital maintained that safeguards were put in place to protect against conflicts of interest during the collaboration. Nevertheless, amid public outcry, Nabel stepped down from the board.

But this story is just one high-profile case of what is commonplace in the hospital sector. A 2014 research letter published in the Journal of the American Medical Association found that 40 percent of pharmaceutical company boards of directors had at least one member who also held, at the same time, a leadership role at an academic medical center.

Read More

Madison, Wisconsin / USA - April 24th, 2020: Nurses at Reopen Wisconsin Protesting against the protesters protesting safer at home order rally holding signs telling people to go home.

Great Responsibility: Navigating Moral Hazards During COVID-19

By Jacqueline Salwa

Younger people may be driving the COVID-19 pandemic in part because they perceive the costs of complying with public health measures as higher and the expected benefits as lower compared with older individuals.

”Indemnifying Precaution: Economic Insights for Regulation of a Highly Infectious Disease,” a paper recently published in the Journal of Law and the Biosciences, explores how to align costs and benefits so that individuals of all ages adhere to precautions.

Younger people tend to experience less severe symptoms from COVID-19 infection, and may be disproportionately affected by other aspects of the pandemic.  These include depression from lack of social interaction, stifled career advancement, and difficulties with providing for dependents.  Compared to younger people, older people have a greater chance of being settled down, retired, and not responsible for dependents. As a result, those that  receive the least benefit from taking precautions, and incur the greatest personal costs for abiding by these precautions, have a lack of incentive to follow precautionary public health measures. This is known, in economic terms, as a moral hazard.

Read More

Syringe and vials of vaccine.

How Does Moderna’s COVID-19 Vaccine Work, and Who Is Funding Its Development?

Cross-posted from Written Description, where it originally appeared on August 19, 2020. 

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Moderna, Inc., a Cambridge, MA-based biotech company, is a leading contender in the race to develop a SARS-CoV-2 vaccine. Moderna’s vaccine, however, works using a completely novel mechanism, unlike any other vaccine currently approved anywhere in the world. Despite this, the U.S. government—and two agencies in particular, the NIH and Biomedical Advanced Research and Development Authority (BARDA)—has invested, heavily, in the vaccine’s development. This week, we explore how these investments interact through different forms of research partnerships, and what this says about IP, novel technologies, and innovation policy.

Read More