AI (Re)Defining Pharmaceutical Exclusivities
Academic Article
Overview
Research
Identity
Additional Document Info
Other
View All
Overview
abstract
This articles central thesis is twofold. First, the increased use of artificial intelligence (AI) technology, biomarkers, and new communications technologies have reduced both the time required (the time cost) and the associated monetary cost for conducting clinical trials, warranting a reduction in term of regulatory exclusivities, particularly for biologics. Second, the premise on which these exclusivities have been grated remain arguable and susceptible to misuse at a time when COVID-19 has exacerbated the need for policies that prioritize public health and access to health care. The article concludes that it is urgent to minimize the term of regulatory exclusivities.