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Impact of Journal of Law and the Biosciences Continues to Grow

The Journal of Law and Biosciences offers high-quality, open-access scholarship at the intersection of the biosciences and law. It is the first fully open-access, peer-reviewed legal journal to focus on these issues. The journal has international impact, with authors from across the globe vying for the opportunity to have their work published in the JLB.

Recently, the Journal of Law and the Biosciences received exciting news in the form of an updated impact factor score. The journal now has an impact factor of 3.583, a substantial increase from the year prior. It ranks #7 out of 151 law journals, an admirable position for the youngest journal included in the rankings. It is also second out of sixteen journals in the medical ethics category, as well as second out of seventeen journals in the legal medicine category.

In honor of this achievement, the Journal has compiled a list of the most impactful articles included in this calculation period.

The Journal continues to publish a wide variety of exciting new material. The most recent issue, which closed in June 2021, contains numerous articles from highly regarded scholars exploring hot-button issues in bioethics. The following excerpts offer a small preview of the wide breadth of analysis contained in the most recent edition.

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international connections concept art.

The Prospects for an IP Waiver Under the TRIPS Agreement

By Duncan Matthews and Timo Minssen

The informal meeting of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council today, July 6, 2021, focuses international attention once more on prospects for a waiver of the TRIPS Agreement in response to the COVID-19 pandemic.

Regardless of whether an actual TRIPS waiver ultimately comes to pass, the real significance of these efforts lies in the increased focus they have placed on the role of IP and trade secrets in improving access and affordability, and scaling-up of manufacturing and supply of vaccines and other health-related technologies. These conversations have introduced the possibility of a rethinking of the relationship between IP, innovation, conservation, and access.

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Photo of person with gloved hand holding flask at lab bench.

US Support for a WTO Waiver of COVID-19 Intellectual Property – What Does it Mean?

By Jorge L. Contreras

On May 5, 2021, U.S. Trade Representative Katherine Tai announced that the U.S. would support a “waiver of IP protections on COVID-19 vaccines to help end the pandemic” currently being discussed at the World Trade Organization (WTO). This announcement, representing a reversal of longstanding U.S. policy toward intellectual property, came as a welcome surprise to much of the world, but elicited strong negative responses from the pharmaceutical industry as stock prices of leading vaccine producers sank.

In the short time since the announcement was made, there has been a fair amount of speculation, hyperbole, and misinformation on the topic. In this post, I offer an explanation of what just happened, and my guess as to what its likely effects will be, bearing in mind that the situation is fast-moving and somewhat unpredictable.

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Patient receives Covid-19 vaccine.

10 Design Considerations for Vaccine Credentials

By Adrian Gropper

As COVID-19 vaccines become widely, if not fairly, available in different regions, both the public and private sector are working to develop vaccine credentials and associated surveillance systems.

Information technology applied to vaccination can be effective, but it can also be oppressive, discriminatory, and counter-productive.

But these systems can be tuned to reflect and address key concerns.

What follows is a list of ten separable concerns, and responsive design strategies. The concept of separation of concerns in technology design offers a path to better health policy. Because each concern hardly interacts with the others, any of them can be left out of the design in order to prioritize more important outcomes. Together, all of them can maximize scientific benefit while enhancing social trust.

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Syringe being filled from a vial. Vaccine concept illustration.

The COVID-19 Vaccine Patent Waiver: The Wrong Tool for the Right Goal

By Ana Santos Rutschman and Julia Barnes-Weise

As the toll of COVID-19 continues to increase in many countries in the Global South, there has been a renewed push to address the problem of vaccine scarcity through a waiver of patent rights. Calls for waivers have been recurring throughout the pandemic, from formal proposals introduced in 2020 by some of the larger developing economies (India and South Africa), to op-eds in mainstream media, and editorials in scientific publications, such as Nature. This push gained momentum in early May 2021, just before the meeting of the World Trade Organization’s General Council.

Waiver proposals have attracted the support of prominent names in public health. Dr. Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, endorsed patent waivers as a tool to address the current vaccine scarcity problem in an article titled Waive Covid Vaccine Patents to Put World on “War Footing.” Others — including, most recently, Dr. Anthony Fauci — have been critical of waiver proposals.

In this piece, we explain the mechanics of patent waivers and argue that waivers alone are the wrong policy tool in the context of the COVID-19 pandemic. We agree with supporters of the waivers in their ultimate goal — that of scaling up the manufacturing of COVID-19 vaccines, and then distributing them according to more equitable models than the ones adopted thus far. However, we doubt that the particular types of goods at stake here can be easily replicated and produced in substantially larger quantities simply through a waiver of intellectual property rights.

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Illustration of fetus, DNA, lab supplies

Assisted Reproductive Technologies: A Bioethical Argument for Medicaid Coverage

By Sravya Chary

Assisted reproductive technologies (ARTs) such as artificial insemination, egg retrieval, and in-vitro fertilization (IVF) have revolutionized the landscape for people facing reproductive obstacles. Disappointingly, none of these technologies are covered under Medicaid — an insurance program for low-income adults and children, and people with qualifying disabilities.

Given the high prices of ARTs, those on Medicaid, which includes a disproportionate number of BIPOC individuals, are left behind in sharing the benefits of advancements in reproductive technologies. It is vital for ARTs to be covered under Medicaid to uphold reproductive justice and autonomy for this patient population.

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Vial and syringe.

4 Things to Know About Intellectual Property, Patent Pledges, and COVID-19 Vaccines

By Chloe Reichel

High-profile commentators have argued recently that vaccine scarcity needn’t exist. If vaccine manufacturers simply shared their patents with other pharmaceutical companies, supply would quickly ramp up. 

Others have pointed out that numerous bottlenecks exist in the manufacturing process, from the glass vials that hold the vaccine, to the lipids that encase the vaccine’s active ingredient, mRNA.

And even if these bottlenecks didn’t exist, the intellectual property argument may be a straw man.    

In fact, this past October, Moderna made a gesture toward opening access to its intellectual property, by pledging that it would not enforce its patents against “those making vaccines intended to combat the pandemic.” That month, Jorge L. Contreras, a Presidential Scholar and Professor of Law at the University of Utah, covered the patent pledge and its potential implications for Bill of Health.

We checked in with Contreras to ask about the implications of Moderna’s patent pledge now that its vaccine has been proven safe and effective. Here are the highlights from the conversation:

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lady justice.

Computational Psychiatry for Precision Sentencing in Criminal Law

By Francis X. Shen

A core failing of the criminal justice system is its inability to individualize criminal sentences and tailor probation and parole to meet the unique profile of each offender.

As legal scholar, and now federal judge Stephanos Bibas has observed, “All too often … sentencing guidelines and statutes act as sledgehammers rather than scalpels.”

As a result, dangerous offenders may be released, while offenders who pose little risk to society are left behind bars. And recidivism is common — the U.S. has an astounding recidivism rate of 80% — in part because the current criminal justice system largely fails to address mental health challenges, which are heavily over-represented in the justice system.

Advances in computational psychiatry, such as the deep phenotyping methods explored in this symposium, offer clinicians newfound abilities to practice precision psychiatry. The idea behind precision psychiatry is both simple and elusive: treat individuals as individuals. Yet advancing such a program in practice is “very ambitious” because no two individual brains — and the experiences those brains have had over a lifetime — are the same.

Deep phenotyping offers the criminal justice system the tools to improve public safety, identify low-risk offenders, and modify decision-making to reduce recidivism. Computational psychiatry can lead to what can be described as precision sentencing.

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phone camera

Deep Phenotyping Could Help Solve the Mental Health Care Crisis

By Justin T. Baker

The United States faces a growing mental health crisis and offers insufficient means for individuals to access care.

Digital technologies — the phone in your pocket, the camera-enabled display on your desk, the “smart” watch on your wrist, and the smart speakers in your home — might offer a path forward.

Deploying technology ethically, while understanding the risks of moving too fast (or too slow) with it, could radically extend our limited toolkit for providing access to high-quality care for the many individuals affected by mental health issues for whom the current mental health system is either out of reach or otherwise failing to meet their need.

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Life preserver on boat.

Incidental Findings in Deep Phenotyping Research: Legal and Ethical Considerations

By Amanda Kim, M.D., J.D., Michael Hsu, M.D., Amanda Koire, M.D., Ph.D., Matthew L. Baum, M.D., Ph.D., D.Phil.

What obligations do researchers have to disclose potentially life-altering incidental findings (IFs) as they happen in real time?

Deep phenotyping research in psychiatry integrates an individual’s real-time digital footprint (e.g., texts, GPS, wearable data) with their biomedical data (e.g., genetic, imaging, other biomarkers) to discover clinically relevant patterns, usually with the aid of machine learning. Findings that are incidental to the study’s objectives, but that may be of great importance to participants, will inevitably arise in deep phenotyping research.

The legal and ethical questions these IFs introduce are fraught. Consider three hypothetical cases below of individuals who enroll in a deep phenotyping research study designed to identify factors affecting risk of substance use relapse or overdose:

A 51-year-old woman with alcohol use disorder (AUD) is six months into sobriety. She is intrigued to learn that the study algorithm will track her proximity to some of her known triggers for alcohol relapse (e.g., bars, liquor stores), and asks to be warned with a text message when nearby so she can take an alternative route. Should the researchers share that data?

A 26-year-old man with AUD is two years into sobriety. Three weeks into the study, he relapses. He begins arriving to work inebriated and loses his job. After the study is over, he realizes the researchers may have been able to see from his alcohol use surveys, disorganized text messages, GPS tracking, and sensor data that he may have been inebriated at work, and wishes someone had reached out to him before he lost his job. Should they have?

A 35-year-old man with severe opioid use disorder experiences a near-fatal overdose and is discharged from the hospital. Two weeks later, his smartphone GPS is in the same location as his last overdose, and his wearable detects that his respiratory rate has plummeted. Should researchers call EMS? Read More