Centralizing Pharmaceutical Innovation

54 Pages Posted: 23 May 2023 Last revised: 15 May 2024

See all articles by Sapna Kumar

Sapna Kumar

University of Minnesota Law School

Date Written: March 9, 2024

Abstract

The United States has a mostly decentralized system for promoting new medicine development. By offering patents and regulatory exclusivities, the government incentivizes pharmaceutical companies to invent and bring to market new medicines. Although this development model offers benefits for promoting innovation, it comes at a cost: Market-based incentives lead companies to prioritize research and development (“R&D”) for medicines that offer a safe path to profitability, as opposed to those that offer the greatest social benefit. In particular, pharmaceutical companies are reluctant to invest in R&D for critically-needed antibiotics and infectious disease vaccines—both of which are difficult to develop and provide uncertain financial returns. This Article proposes that the government oversee the development of needed “infrastructure-adjacent medicines”—medicines that can help prevent future collapses of the public healthcare system and mitigate major economic harm. In addition to boosting internal R&D in such critical areas, the government could directly support innovation by exclusively licensing promising drug candidates from small- to mid-sized entities or by purchasing small biotechnology companies on the open market. When suitable private partners are not available, the government could oversee the final stages of development and retain control over the resulting intellectual property rights. This approach would allow private-sector pharmaceutical development to continue to flourish while filling a critical public health gap.

Note:
Funding Information: Part of this article was researched in residency at the University of Copenhagen’s Centre for Advanced Studies in Biomedical Innovation; the visit was supported through a grant funded by the Novo Nordisk Foundation.

Declaration of Interests: This project was completed while the author was in residency at the University of Copenhagen's Centre for Advanced Studies in Biomedical Innovation (CeBIL). The author's travel was partially supported by a CeBIL visitor grant, which was funded by the Novo Nordisk Foundation. The Novo Nordisk Foundation had no input over the author's research and did not influence the research in any way.

Suggested Citation

Kumar, Sapna, Centralizing Pharmaceutical Innovation (March 9, 2024). 83 Maryland L. Rev. 653 (2024), Minnesota Legal Studies Research Paper No. 23-24, Available at SSRN: https://ssrn.com/abstract=4324061 or http://dx.doi.org/10.2139/ssrn.4324061

Sapna Kumar (Contact Author)

University of Minnesota Law School ( email )

MN TX
United States

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