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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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We Need to Do More with Hospitals’ Data, But There Are Better Ways

By Wendy Netter Epstein and Charlotte Tschider

This May, Google announced a new partnership with national hospital chain HCA Healthcare to consolidate HCA’s digital health data from electronic medical records and medical devices and store it in Google Cloud.

This move is the just the latest of a growing trend — in the first half of this year alone, there have been at least 38 partnerships announced between providers and big tech. Health systems are hoping to leverage the know-how of tech titans to unlock the potential of their treasure troves of data.

Health systems have faltered in achieving this on their own, facing, on the one hand, technical and practical challenges, and, on the other, political and ethical concerns.

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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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Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

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The Only Constant is Resistance to Change: A Flaw in the US Response to Public Health Crises

By Jennifer S. Bard

Law can be a wonderful tool for promoting and protecting the public’s health. But its inherent bias towards stability is poorly suited to the challenges of addressing rapidly evolving public health crises.

Two current examples — the ongoing opioid overdose crisis, and the COVID-19 pandemic — illustrate the issue starkly.

In both cases, the measures needed to address these two serious crises are hampered by one of the core weaknesses of the U.S. legal system when it comes to addressing serious, ongoing public health crises: there is no mechanism to make swift, responsive adjustments to the law in the face of changing information.

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America’s Underinsurance Crisis in the Age of COVID-19

By Dessie Otachliska

The COVID-19 pandemic has shone a light on the underinsurance crisis that has long kept millions of Americans on the precipice of financial disaster — just one unexpected illness or injury away from bankruptcy.

A 2019 Gallup poll showed that 25% of Americans reported delaying treatment for serious medical conditions due to cost concerns — the highest proportion since Gallup first began asking the question in 1991. Even during the pandemic, when medical treatment could mean the difference between life and death, studies show that nearly 1 in 7 Americans would avoid seeking medical care if they experienced key COVID-19 symptoms because of fears associated with the cost of treatment.

These statistics are unsurprising, and the concerns they underscore well-founded: the average treatment costs for COVID patients with symptoms serious enough to require inpatient hospital stays range from $42,486 for relatively mild cases to $74,310 for patients with major complications or comorbidities.

In the pandemic context, hesitance to seek medical treatment due to fear of the associated cost has proved tragically fatal. Darius Settles died after being dissuaded from seeking further COVID-19 treatment due to his uninsured status. The Nashville, TN hospital where Settles originally received care had failed to disclose the possibility that his medical costs would be covered by the federal government. And, despite the availability of reimbursement funds, the hospital nonetheless sent his widow a bill for a portion of his treatment costs.

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A Proposal for Localized Review to Safeguard Genetic Database Privacy

By Robert I. Field, Anthony W. Orlando, and Arnold J. Rosoff

Large genetic databases pose well-known privacy risks. Unauthorized disclosure of an individual’s data can lead to discrimination, public embarrassment, and unwanted revelation of family secrets. Data leaks are of increasing concern as technology for reidentifying anonymous genomes continues to advance.

Yet, with the exception of California and Virginia, state legislative attempts to protect data privacy, most recently in Florida, Oklahoma, and Wisconsin, have failed to garner widespread support. Political resistance is particularly stiff with respect to a private right of action. Therefore, we propose a federal regulatory approach, which we describe below.

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The Latest on Never Events in the NHS in England

By John Tingle

Never Events” — medical errors that should never occur — are a major and recurring problem in health care in England.

When they do occur, they sap confidence and trust in the health care system, and can result in significant injury or death to the patient. They can result in expensive litigation. There is also a significant financial cost to the NHS, which is always short of financial resources. The patient, their relatives, and all those involved in the incident bear emotional costs, too.

In the National Health Service (NHS), Never Events are defined and listed. The list includes such incidents as a foreign body being left in a patient, wrong implant/prosthesis, and wrong site surgery, among others. Sadly, the incidence of Never Events in the NHS is still too high.

Never Events are also a major patient safety metric that helps regulators such as the Care Quality Commission (CQC) and the public judge the safety of a hospital or other health care facility.

Recent publications highlight that Never Events remain a critical and a stubbornly persistent problem for the NHS to address.

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The Patent Trial and Appeal Board Again Survives Supreme Court Review

By Gregory Curfman

For the generic drug and biosimilar industries, the Supreme Court’s recent decision in United States v. Arthrex, Inc. comes as a relief.

In his opinion, Chief Justice John Roberts allowed the Patent Trial and Appeal Board (PTAB) to survive and to continue to provide an alternative route for generic drugs and biosimilars to gain early market entry.

Patients, who may rely heavily on these less costly alternatives for their prescription drugs, will also benefit significantly from the Court’s decision in this case.

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