Ana Santos Rutschman, SJD, LLM
Professor of Law; Faculty Director, Health Innovation Lab | Villanova University
Villanova, PA, UNITED STATES
Professor Rutschman, SJD, LLM researches topics in health law, biotech, innovation policy, patent law, and law and technology.
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Areas of Expertise (9)
Drug Prices
Intellectual Property/Patent
Innovation Policy
Health/Bio 3D Printing
Health AI
Vaccines
Pharmaceuticals
Biotech
Health Tech
Biography
Ana Santos Rutschman is Professor of Law and Faculty Director of the Health Innovation Lab at Villanova University Charles Widger School of Law, where she teaches and researches topics related to health law, intellectual property, innovation in the life sciences, and law and technology. She is a nationally and internationally recognized expert on vaccine law and policy, the regulation of emerging health technologies, and access to medicines.
Professor Rutschman’s work has been recognized by numerous institutions, including the American Society of Law Medicine & Ethics, which named her a Health Law Scholar in 2018 and Bio Intellectual Property Scholar in 2017. In 2018, she was also named a Wiet Life Sciences Law Scholar by the Beazley Institute for Health Law and Policy at Loyola University Chicago. In 2022, the Boston Congress of Public Health selected her as one of the inaugural recipients of a 40 Under 40 Public Health Catalyst Award for her work on vaccine law and policy.
Professor Rutschman’s book, Vaccines as Technology: Innovation, Barriers and the Public Health, was published in 2022 by Cambridge University Press. Her legal scholarship has appeared or is forthcoming in UCLA Law Review, Emory Law Journal, Indiana Law Journal, UC Davis Law Review, Arizona Law Review, Yale Law Journal Forum, Harvard Public Health Review and Vanderbilt Journal of Transnational Law, among several others. Her peer-reviewed work has appeared in Nature Biotechnology, Vaccine, Emerging Infectious Diseases and American Journal of Infection Control, among others. Her commentary pieces have been published by Health Affairs Blog, Bill of Health, Saint Louis Post-Dispatch, the Huffington Post and The Conversation, and republished in Scientific American, Newsweek Japan and numerous U.S. newspapers.
Before joining Villanova Law in 2022, Professor Rutschman taught in the health law program at Saint Louis University School of Law (2018-2022) and served as the inaugural Jaharis Fellow in Health Law and Intellectual Property at DePaul University College of Law in Chicago (2016-2018). Professor Rutschman has also consulted for the World Health Organization in (2022 and 2015-2016) on matters related to the development of drugs and vaccines against COVID-19, Zika and Ebola.
Links (4)
Select Media Appearances (12)
23andMe Wants to Sell its Most Valuable Asset. Will your Private DNA Data be Safe?
MarketWatch online
2025-03-27
“There is nothing specific in bankruptcy law that automatically protects the data of 23andMe’s consumers in this situation,” Ana Santos Rutschman, law professor and faculty director of the Health Innovation Lab at Villanova University, told MarketWatch via email. “The Bankruptcy Code only says that companies cannot sell identifiable personal information unless the sale is enabled by that company’s privacy policy.”
Could RFK Jr. Really Take Away ADHD Medication?
Rolling Stone online
2025-02-23
Banning or restricting access to any medication currently used in the treatment of ADHD would have to involve the Food and Drug Administration (FDA), which falls under and follows the policies of the Kennedy-led Department of Health and Human Services, Rutschman says. “These ADHD drugs have been approved by the FDA — which by law has to make a determination that a drug is safe and effective before a company can sell it,” she says. “Also by law, the FDA can withdraw approval or restrict distribution if new evidence suggests that an approved drug is not safe or effective.” So, banning or restricting access to these drugs would require some sort of FDA-initiated decision based on data raising concerns about a specific ADHD drug. According to Rutschman, the MAHA Commission report itself wouldn’t be a sufficient source of this data; rather, it would need to come from several studies reflecting the current “scientific consensus” demonstrating that a specific ADHD drug was causing issues, or was not effective.
Trump's Pick for FDA to Test 'Due Diligence' of Agency's Science
Bloomberg Law online
2024-11-25
Makary could take “positive steps” in regulating and eliminating “harmful components that are still allowed in food, supplements, food containers and packaging,” according to Ana Santos Rutschman, professor at the Charles Widger School of Law at Villanova University. “Among all the nominations so far in the public health space, this is the candidate with the strongest credentials,” Rutschman said. “And I think that there is, at least for now and in theory, room for some positive developments at the FDA.”
5 Ways R.F.K. Jr. Could Undermine Lifesaving Childhood Vaccines
The New York Times print
2024-11-19
Under a longstanding federal law, people who experience serious side effects after receiving certain routine vaccinations are limited in their ability to sue drug companies. Instead, they can seek compensation through a government-run program. The law is intended to encourage drug companies to invest in vaccine development. Mr. Kennedy could not make major changes to the law without congressional approval, but he could remove specific vaccines from the program. Whether he could take every vaccine off the list is “difficult to say, because it’s uncharted waters, legally speaking,” said Ana Santos Rutschman, an expert on health law and policy at Villanova University.
Covid Vaccine Makers to Clash in London over mRNA Patent Dispute
Financial Times online
2024-04-22
If successful, Moderna would be in line for a share of the profits Pfizer and BioNTech generated from their joint vaccine, Comirnaty. Legal experts said the London ruling could also influence litigation in other jurisdictions — and boost the reputations of the winners. “This is a legal battle, but it’s a PR battle in many ways,” said Ana Santos Rutschman, a law professor at Villanova University in the US state of Pennsylvania, who is an expert in life sciences intellectual property. “It’s about becoming the lead player in the mRNA field.”
Asthma Meds Have Become Shockingly Unaffordable − But Relief May be on the Way
The Conversation online
2024-03-08
The price of asthma medication has soared in the U.S. over the past decade and a half. The jump – in some cases from around a little over US$10 to almost $100 for an inhaler – has meant that patients in need of asthma-related products often struggle to buy them. Others simply can’t afford them. To make matters worse, asthma disproportionately affects lower-income patients. Black, Hispanic and Indigenous communities have the highest asthma rates. They also shoulder the heaviest burden of asthma-related deaths and hospitalizations. Climate change will likely worsen asthma rates and, consequently, these disparities.
Pennsylvania AG's Clout in Opioid Deal Likely has Wide Reach
Law 360 online
2024-02-02
Although there are still pending county lawsuits against companies in the opioid business, Villanova Law professor Ana Santos Rutschman said she didn't think the conflict would come up again in any more opioid cases. She said it was predictable that such conflicts might arise when local officials disagree over whether a settlement reflects the damage done to the communities they see firsthand. But the Commonwealth Court's opinion had reinforced a "pyramid"-style hierarchy between the state and county officials.
How Theranos’ faulty blood tests got to market – and what that shows about gaps in FDA regulation | Opinion
The Conversation online
2021-10-05
One of the most high-profile trials of the year is underway to decide whether Theranos founder Elizabeth Holmes defrauded patients and investors.
Malicious bots and trolls spread vaccine misinformation – now social media companies are fighting back | Opinion
The Conversation online
2019-09-18
Social media have become one of the preeminent ways of disseminating accurate information about vaccines. However, a lot of the vaccine information propagated across social media in the United States has been inaccurate or misleading. At a time when vaccine-preventable diseases are on the rise, vaccine misinformation has become a cause of concern to public health officials.
Artificial intelligence can now emulate human behaviors – soon it will be dangerously good | Opinion
The Conversation online
2019-04-05
When artificial intelligence systems start getting creative, they can create great things – and scary ones. Take, for instance, an AI program that let web users compose music along with a virtual Johann Sebastian Bach by entering notes into a program that generates Bach-like harmonies to match them.
Will more genetically engineered foods be approved under the FDA’s new leadership? | Opinion
The Conversation online
2019-03-21
The world of food and drug regulation was rocked earlier this month by the news of a change in leadership at the Food and Drug Administration. Commissioner Scott Gottlieb resigned and will step down in early April. His temporary replacement is Dr. Ned Sharpless, director of the National Cancer Institute.
Faster approval for drugs and medical devices under the 21st Century Cures Act raises concerns for patient safety | Opinion
The Conversation online
2017-01-11
President Obama signed a bill that will provide US$6 billion in federal funding for basic medical research on Dec. 13. Called the 21st Century Cures Act, it also introduces changes to how the Food and Drug Administration approves drugs and medical devices, creating two new mechanisms aimed to speed regulatory review to bring medicines and devices to market faster.
Research Grants (3)
Innovation, Business & Law Center Prize (with Ruqaiijah Yearby)
University of Iowa
2020
Beaumont Research Award
Saint Louis University
2020
Spark Microgrant Award (with Timothy Wiemken)
Saint Louis University
2020
Select Academic Articles (9)
Increasing Equity in the Transnational Allocation of Vaccines Against Emerging Pathogens: A Multi-Modal Approach
Journal of Law, Medicine & Ethics2023 This article proposes the adoption of a multi-modal system for allocating vaccine doses during large transnational outbreaks of infectious diseases. The chosen allocative criteria (public health need; country-income level; qualification through funding; and, subsidiarily, a modified lottery system) are adapted from a current embodiment of allocative multi-modality outside the context of public health: the New York City Marathon.
Vaccine Contracts in the Context of Pandemics and Epidemics
New York University Journal of International Law and Politics (JILP)2022 This symposium essay explores the architecture of vaccine contracts, as well as the allocation of resulting vaccines in preparation for, and in response to, pandemics and large-scale epidemics. Drawing on contracts predominantly related to COVID-19 vaccines collected through publicly available databases, the work begins by providing an overview between the relationships between the parties entering into these agreements; the bargaining processes adopted and their timeline relative to market demand for vaccines; and the substantive obligations imposed by these contracts.
Contractual solutions to overcome drug scarcity during pandemics and epidemics
Nature Biotechnology2022 Licensing provisions that obligate recipients of government funding to share relevant technology and know-how for scarce drugs during pandemics and epidemics can reduce shortages and overcome obstacles that intellectual property rights present.
Social Media Self-Regulation and the Rise of Vaccine Misinformation
Penn Carey Law Journals2022
Intellectual Property as a Determinant of Health
Vanderbilt Journal of Transnational Law2021 Public health literature has long recognized the existence of determinants of health, a set of socioeconomic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking.
Property and Intellectual Property in Vaccine Markets
Texas A&M Journal of Property Law2021 As biopharmaceutical forms of technology, vaccines constitute one of the most important tools for the promotion and maintenance of public health. Tolstoy famously wrote that “[h]appy families are all alike; every unhappy family is unhappy in its own way.” Vaccine markets offer perhaps one of the most extreme embodiments of Tolstoy’s principle in the field of biopharmaceutical innovation.
Is There a Cure for Vaccine Nationalism?
Current History2021 The scramble among nations for limited supplies of COVID-19 vaccines has drawn attention to long-standing inequities in public health between the global North and South. The COVID-19 Vaccine Global Access Facility (COVAX) is one of several initiatives to pool resources to acquire vaccines for lower-income countries and coordinate distribution. But months before any vaccine had been approved, high-income countries accounting for only a fraction of the global population had already placed orders for more than half of the projected early supply of vaccine doses.
The COVID-19 Vaccine Race: Intellectual Property, Collaboration(s), Nationalism and Misinformation
Washington University Journal of Law & Policy2021 The COVID-19 pandemic has brought a national and global vaccine race. This Article examines the race with respect to contemporary frameworks for biopharmaceutical research and development. Specifically, this Article focuses on the effect of patents, pre-production agreements, public-private partnerships, and vaccine misinformation. This Article analyzes lessons learned from the COVID-19 pandemic, advocates for promoting vaccine affordability and equity, and suggests modifications to existing preparedness frameworks to prepare for upcoming outbreaks of infectious disease.
IP Preparedness for Outbreak Diseases
UCLA Law Review2018 Outbreaks of infectious diseases will worsen in the coming decades, as illustrated by the recent back-to-back Ebola and Zika epidemics. The development of innovative drugs, especially in the form of vaccines, is key to minimizing the scale and impact of future outbreaks, yet current intellectual property (IP) regimes are ineffective in supporting this goal. Scholarship has not adequately addressed the role of IP in the development of vaccines for outbreak diseases. This Article fills that void. Through case studies on the recent Ebola and Zika outbreaks, it provides the first descriptive analysis of the role of IP from the pre- to the post-outbreak stages, specifically identifying IP inefficiencies.
