Insurance concept. Wooden blocks with insurance icons. family, life, car, travel, health and house insurance icons on blue background.

Autonomy, Insurance, and Luck

By Leslie C. Griffin

You will be surprised I’ve been through all the experiences described in this post, and that I’m still alive to tell you about them. Even I can’t believe it some days. It’s quite a list, so sometimes I mention it to my friends, so they will be as amazed as I am.

I am a lifelong academic, so I also think about what lessons they’ve taught me.

One is the philosophical principle of autonomy, which I regularly teach in my bioethics class. In my opinion, it means you always have to be prepared for the very worst. You have to live knowing it could happen to you. The worst doesn’t always occur. But when it does, you need to find a positive way to look at it and to make good decisions about it.

Two is the practical decision to have your legal documents in place. A durable power of attorney. Health insurance and property insurance. These practical items also help a lot in getting you through terrible situations. Lack of insurance makes everything dreadful.

Autonomy and insurance help you through a lot of crises. My crises include a blizzard, a tornado, an earthquake, a car accident, a hurricane, and two murderers.

You also need good luck.

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South Carolina State House.

South Carolina’s Abortion Debates: A Game of Ping Pong

By Katie Gu

On January 5, the South Carolina Supreme Court permanently struck down Senate Bill 1 (S.B. 1), also known as the Fetal Heartbeat and Protection from Abortion Act, which banned most abortions after the sixth week of pregnancy. The decision was issued just five days before the state’s General Assembly returned for 2023, setting into motion a game of ping pong between the state branches of government in South Carolina’s abortion debates. 

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Adderall bottle on shelf.

Losing Control of Controlled Substances? The Case of Telehealth Prescriptions 

By Minsoo Kwon

Telehealth services that specialize in the treatment of mental health concerns, such as Cerebral Inc., highlight the ongoing challenge of appropriately balancing accessibility of care with patient safety.

While increased accessibility of mental health care services through telehealth is a valuable goal, if our aim is the well-being of patients, safety must be paramount.

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Supreme Court of the United States.

What the Supreme Court’s Expected Ruling on Affirmative Action Might Mean for US Health Care

By Gregory Curfman

Affirmative action in higher education may soon be abolished by the Supreme Court, resulting from its review of Students for Fair Admissions v. Harvard and Students for Fair Admissions v. University of North Carolina.

The consequences for the physician workforce may be dire. Diversity among physicians is a compelling interest in our increasingly diverse society. Without affirmative action in higher education, our physician workforce may become less diverse, and the quality of health care may suffer.

This article explains the history of affirmative action in the U.S., past Supreme Court decisions, and the key arguments being considered in the two cases currently under review.

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Black and white exterior of Legislative chambers of Washington State with inscription and pillars.

Tracking Public Health Authority Changes from 2021 & 2022 Legislative Sessions

By Temple University Center for Public Health Law Research

COVID-19 called for quick, decisive action by public health authorities to support communities and prevent infections. Since the pandemic began, legislators around the country have been acting to change the way authorities may respond to future public health emergencies — expanding or limiting officials’ authority to act in an emergency, changing who has authority to act, and the actions they may have the authority to take.

New research by the Center for Public Health Law Research at Temple University’s Beasley School of Law, in collaboration with the Association for State and Territorial Health Officials and the Network for Public Health Law, capture details of legislation that addresses emergency health authority introduced between January 1, 2021, and May 20, 2022, in all 50 states and the District of Columbia.

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U.S. Patent and Trademark Office building

Visualizing the Growing Intersection of Life Sciences and Computing Patents in the US from 1976-2021

By Matthew Chun

With its leadership in drug development, biotechnology, and computing technologies, the United States touts itself as being “the most innovative economy in the world.”

But when did the U.S. rise to its position as a global leader in these areas? Which regions of the country have led the charge? And what is the next frontier of American innovation?

To begin exploring these questions, I analyzed 45 years of publicly available patent data to map the growth of U.S. innovation in the life sciences and computing fields from 1976-2021. I also mapped the recent growth of patented “hybrid” inventions, which are closing the gap between these historically disparate fields. In particular, the hybrid inventions explored in this project represent interdisciplinary advances in areas including bioinformatics, cheminformatics, artificial intelligence, and quantum computing.

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pills

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

By Ameet SarpatwariAviva Wang, 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 relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from a discussion of antitrust as a tool to address patent thickets, to an analysis of the relationship between price and efficacy for recently approved cancer drugs, to an examination of the viability and implications of preemption challenges to state laws restricting medication abortion.

A full posting of abstracts/summaries of these articles may be found on our website.

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Bill of Health - Globe and vaccine, covid vaccine

Biotech Companies Are Opening Manufacturing Sites in Africa: Will This Help Vaccine Equity?

By Sarah Gabriele

Two pharmaceutical giants of the pandemic, Moderna and BioNTech, are taking steps for increasing the manufacturing capacity for the COVID-19 vaccine in Africa. Last March, Moderna announced its plan to set up a manufacturing facility in Kenya to produce messenger RNA (mRNA) vaccines, including COVID-19 shots. Similarly, in 2021, BioNTech started planning its own manufacturing plant in Africa, which will be composed of modular shipping containers.

Measures to address global vaccine inequity could not come sooner. As of December 15, 2022, only 34% of the population in Africa has received at least one dose of the COVID-19 vaccine, with Moderna and BioNTech having provided fewer doses compared to Oxford-AstraZeneca and Johnson & Johnson. After failing to successfully deliver vaccines equitably during the first two years of the pandemic, Moderna and BioNTech appear now to be taking steps to shoulder greater responsibility for vaccine equity.

However, if companies are ethically required to address the availability of vaccines, these well-intended efforts might still fail to fulfill their moral obligations. Indeed, while the construction of these new sites might sound like great news for fostering the delivery of vaccines in low- and middle-income countries, we should be aware that these manufacturing sites, as well as the existence of manufacturing capacity, might not be enough to achieve desired outcomes.

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Grayslake, IL - January 30, 2021: Drive-through indoor COVID-19 vaccination facility at the Lake County Fairgrounds in Grayslake. The facility is dispensing both the Moderna and Pfizer vaccine.

COVID-19 Vaccine Patent Infringement? The Battle Between Moderna and Pfizer/BioNTech Continues

By Aparajita Lath

Last month, the patent battle between COVID-19 mRNA vaccine manufacturers continued with BioNTech/Pfizer filing a strong defense and counter-claim to Moderna’s allegations of patent infringement.

In their initial August 2022 complaint, Moderna alleged that three of its mRNA patents were infringed by Pfizer/BioNTech. Interestingly, as of January 12, 2023, Moderna has listed 10 patents covering Spikevax (its mRNA vaccine) on its website. Since biotechnology inventions can be covered by several patents, each of which may not be easy to identify through public searches, the decision to publish a consolidated list of patents is a move in the right direction. However, the list is an evolving one, and, as it happens, one of three patents at issue, i.e., patent no. 10,933,127 (‘127) has not been listed.

The following article explains the key patents at stake in the intellectual property dispute.

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File folders containing medical records.

How Dobbs Threatens Health Privacy

By Wendy A. Bach and Nicolas Terry

Post-Dobbs, the fear is visceral. What was once personal, private, and one hoped, protected within the presumptively confidential space of the doctor-patient relationship, feels exposed. In response to all this fear, the Internet exploded – delete your period tracker; use encrypted apps; don’t take a pregnancy test. The Biden administration too, chimed in, just days after the Supreme Court’s decision, issuing guidance seeking to reassure both doctors and patients that the federal Health Privacy Rule (HIPAA) was robust and that reproductive health information would remain private. Given the history of women being prosecuted for their reproductive choices and the enormous holes in HIPAA that have long allowed prosecutors to rely on healthcare information as the basis for criminal charges, these assurances rang hollow (as detailed at length in our forthcoming article, HIPAA v. Dobbs). From a health care policy perspective, what is different now is not what might happen. All of this has been happening for decades. The only difference today is the sheer number of people affected and paying attention.

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