When Should Regulatory Adaptation Be Centralized Vs Decentralized? Lessons From Covid on Technological Complexity, Local Capabilities, and Speed

40 Pages Posted: 6 Mar 2024

See all articles by Afonso Amaral

Afonso Amaral

Department of Engineering an Public Policy; Center for Innovation, Technology and Policy Research, IN+

M. Granger Morgan

Carnegie Mellon University - Department of Engineering and Public Policy

Joana Mendonça

Technical University of Lisbon (UTL)

Erica R.H. Fuchs

Department of Engineering and Public Policy, Carnegie Mellon University

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Date Written: February 23, 2024

Abstract

This paper unpacks how centralization (vs. decentralization) of the regulatory process may affect the speed and efficacy with which a nation or region can expand its internal innovation and production capacity when access of technologically complex safety critical products suddenly become limited. We focus on European regulation of new entrants into mechanical ventilators and vaccines during the recent COVID-19 pandemic. We draw insights from 77 semi-structured interviews with experts from industry, healthcare workers, regulators, non- profit organizations, and research centers. Our results show that centralized adaptations to established market entry regulations resulted in equitable access of emerging innovations to all EU Member-States. In contrast, decentralized adaptations benefitted only those Member-States that already had strong domestic industries and dynamic regulatory capabilities. We conclude by proposing new theory on when centralized versus decentralized regulatory approaches are best positioned to regulate market entry in safety-critical products, and how this may differ for technologically simple versus complex products.

Keywords: Regulatory adaptations; Firm entry; Critical products; Public Policy; Technological complexity; Cross-institutional collaboration

Suggested Citation

Amaral, Afonso and Morgan, M. Granger and Mendonça, Joana and Fuchs, Erica Renee, When Should Regulatory Adaptation Be Centralized Vs Decentralized? Lessons From Covid on Technological Complexity, Local Capabilities, and Speed (February 23, 2024). Available at SSRN: https://ssrn.com/abstract=4736774 or http://dx.doi.org/10.2139/ssrn.4736774

Afonso Amaral (Contact Author)

Department of Engineering an Public Policy ( email )

Pittsburgh, PA 15213-3890
United States

Center for Innovation, Technology and Policy Research, IN+ ( email )

Lisbon
Portugal

M. Granger Morgan

Carnegie Mellon University - Department of Engineering and Public Policy ( email )

Baker Hall 129
5000 Forbes Avenue
Pittsburgh, PA 15213
United States

Joana Mendonça

Technical University of Lisbon (UTL) ( email )

R. Miguel Lupi, 20
Lisbon, 1200
Portugal

Erica Renee Fuchs

Department of Engineering and Public Policy, Carnegie Mellon University ( email )

Pittsburgh, PA 15213-3890
United States

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