Center for Law, Health & Society faculty member and co-director of the Center for Intellectual Property, Yaniv Heled, was promoted to full professor this year. Heled teaches courses in biotechnology and intellectual property. His research focuses on the legal and ethical issues at the intersection of these two topics.
Recently, Heled has been applying his expertise to the COVID-19 outbreak, in collaboration with Ana Santos Rutschman, Saint Louis University School of Law, and Liza Vertinsky, Emory University School of Law. He has explored adoption of a defense of necessity, similar to that in tort law, to allow for health care entities to potentially avoid liability for infringement of intellectual property protections and speed access to lifesaving interventions needed to prevent or mitigate public health emergencies.
He and his colleagues also examine the increasing distrust of the FDA, characterizing the agency’s COVID-19 efforts as “regulatory reactivity,” to external pressures and responding outside of traditional protocols. They suggest changes to how agency action is reviewed by courts where such action goes against scientific knowledge and advice.
The FDA’s emergency use authorization process is necessary to release COVID-19 vaccines quickly to stem the pandemic; however, it has also been criticized as being politically influenced and not scientifically sound when authorizing treatments such as chloroquine, hydroxychloroquine, and convalescent plasma. Heled and his colleagues suggest an independent review body modeled after the former Congressional Office of Technology Assessment to address the FDA’s eroded trust.