AI (Re)Defining Pharmaceutical Exclusivities

Document Type

Article

Publication Date

2-2022

Journal Title

Biotechnology Law Report

ISSN

0730-031X

DOI

10.1089/blr.2021.29257.sr

Abstract

This article’s 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.

First Page

23

Last Page

29

Num Pages

7

Volume Number

41

Issue Number

1

Publisher

Mary Ann Liebert, Inc.

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