Faculty Scholars: Ana Santos Rutschman
When the FDA approves a new medicine, vaccine, or medical device, there’s a tendency to assume it gets released into the marketplace and reaches those who need it. Professor of Law Ana Santos Rutschman works to illuminate the gap between what should happen and what actually does happen—because, as she notes, “not everyone who needs access gets it.”
“In order to think about social justice and economics, you have to understand invisible things, such as FDA regulations or those that apply to the industry and to medical professionals,” Rutschman says. “You have to look at corporate structures and patents. You have to look at financing mechanisms: Medicare, Medicaid, private insurance. I teach all of these ‘invisible things’ to my students.”
Rutschman, who launched her academic career in 2016 and joined ֱ Law last fall, is also a consultant to the World Health Organization (WHO). In 2018, she knew from her work with the WHO and other public health experts that a pandemic was looming. No one could say which pathogen would be the culprit, but Ebola and coronaviruses were top concerns. And that gave her work new urgency.
“I was already looking at the intellectual property side of vaccine development,” she recalls. “You cannot make a vaccine before there is a problem, and you cannot give it to people before you know what the pathogen is like.” And furthermore, Rutschman adds, market-driven methods of developing, producing, and allocating vaccines are often at odds with public health needs. Her research resulted in several publications, including “IP Preparedness for Outbreak Diseases” in the UCLA Law Review (2018) and “The Vaccine Race in the 21st Century” in the Arizona Law Review (2019).
When COVID-19 emerged in 2020, Rutschman’s work garnered attention from journalists and public health organizations looking for answers—keeping her quite busy. And she continued to focus on other vaccine-related issues. “We tend to think of vaccines as instruments of public health, but there are a host of other considerations,” she says. For instance, would people trust the FDA and this expedited way of introducing vaccines? Can employers require employees to take them, and what are the ramifications if they refuse? How can we counter health misinformation? Since patents limit who can commercialize vaccines, can other companies and countries obtain a license to produce them?
Her work culminated in a well-timed book, Vaccines as Technology: Innovation, Barriers, and the Public Health, published in 2022 by Cambridge University Press. In coming to ֱ that same year, she saw an exciting opportunity to grow and shape the health law program. “We have some of the best IP people in the country,” Rutschman says. “We also have other great schools across the university, and the law school does not operate in isolation.” She sees ֱ’s location as an advantage, given its proximity to the area’s pharmaceutical industry and the “regulatory corridor” of the Northeast.
Rutschman continues to immerse herself in researching an array of topics related to health law and intellectual property, including pharmaceutical patents as well as patents covering the use of artificial intelligence in vaccine development and production. She is also examining the ongoing negotiations over a proposed pandemic treaty that would strengthen future prevention, preparedness and response.
“The one thing I am most interested in is how do we get pharmaceuticals and medical devices to people who need them,” she says. “Contributing to that dialogue in public health is what I really value.” That not only means publishing in legal and scientific journals but also presenting at conferences attended by researchers, scientists, public health experts and regulators from the FDA and CDC. “I like talking to people who are not just in academia. A university can never be just a campus unto itself,” she adds.
“I’m looking forward to developing the program here and also bringing more health law speakers into the building—professors and practitioners from other institutions,” Rutschman says. “And we can continue to grow connections within ֱ. It really is about the bigger picture, and I am sure this will inform my own scholarship for years to come.”
Learn more about Professor SantosRutschman and her recent publications.