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 collab ..read more

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 “hybr ..read more

By Barbara Pfeffer Billauer Throughout the COVID-19 pandemic, much air time and social media space has been allocated to the lab leak vs. natural spillover dispute regarding the origins of SARS-CoV-2. To summarize briefly, the question is whether the pandemic was caused by a leak from a biosafety level (BSL) four lab in Wuhan, China, or whether it arose naturally as a consequence of a virus jumping from a bat to an animal and then to humans. Given that the “truth” will likely never be known, and certainly not provable, the question becomes: is it important to seriously consider the lab leak th ..read more

By Ameet Sarpatwari, Aviva 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 bet ..read more

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 ha ..read more

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 decis ..read more

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 ..read more

By Krista Cezair Black women are less likely to receive mental health diagnosis, treatment, and care than their white counterparts. To begin to address these disparities, I suggest building on the recent proposal drafted by the United States Preventive Services Task Force (USPSTF), which calls for primary care physicians to screen all adults aged 64 years or younger, including pregnant and postpartum persons, for anxiety disorders as part of their routine care. In this article, I suggest that mental health screening for Black women should include screening for depression in addition to anxiety ..read more

By Katie Gu The past may hold important lessons for our uncertain future of health privacy for patients, physicians, and hospitals in the face of abortion subpoenas post-Dobbs.  In returning the legality of abortion back to states, the Supreme Court’s decision has paved the path towards greater surveillance of sensitive health data contained in patient medical records. This stark increase in privacy risks for individuals seeking reproductive care resembles the shifts in patient privacy protections nearly twenty years ago following the Partial-Birth Abortion Ban Act (PBAB).  Enacted i ..read more

By Timothy Bonis Although three in four doctors support scrapping state medical boards in favor of a single federal license, such sweeping reform is likely far off. It is not just state boards’ political obstructionism standing in the way. Basic constitutional federalism limits Congress’s ability to assume powers traditionally held by the states, leaving medical licensure (a state matter since its 19th-century inception) difficult to federalize. This post will explore potential constitutional arguments for and against federal licensure, investigate the constitutionality of more moderate legisl ..read more