The Challenges of Regulatory Pluralism

Gillner, Sandra; Blankart, Katharina Elisabeth; Bourgeois, Florence Tanya; Stern, Ariel Dora; Blankart, Carl Rudolf (2024). The Challenges of Regulatory Pluralism Health Policy, 149, p. 105164. Elsevier Science Direct 10.1016/j.healthpol.2024.105164

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Countries with small and/or less-resourced regulatory authorities that operate outside of a larger medical product regulatory system face a regulatory strategy dilemma. These countries may rely on foreign well-resourced regulators by recognizing the regulatory decisions of large systems and following suit (regulatory reliance); alternatively, such countries may extend formal decision recognition to regulators in multiple other jurisdictions with similar oversight and public health goals, following a system which we call regulatory pluralism. In this policy comment, we discuss three potential limitations to regulatory pluralism: (i) regulatory escape, in which manufacturers exploit regulatory variation and choose the lowest regulatory threshold for their product; (ii) increased fragmentation and complexity for countries adopting this approach, which may, in turn, lead to inconsistent processes; and (iii) loss of international bargaining power in developing regulatory policies. We argue that regulatory pluralism has important long-term implications, which may not be readily apparent to policy makers opting for such an approach. We advocate for the long-term value of an alternative approach relying on greater collaboration between regulatory authorities, which may relieve administrative pressures on countries with small or less-resourced regulatory authorities, regardless of whether countries pursue a strategy of domestic regulation or regulatory pluralism.

Item Type:	Journal Article (Original Article)
Division/Institute:	School of Health Professions School of Health Professions > Institute of Health Economics and Health Policy
Name:	Gillner, Sandra; Blankart, Katharina Elisabeth; Bourgeois, Florence Tanya; Stern, Ariel Dora and Blankart, Carl Rudolf
Subjects:	H Social Sciences > H Social Sciences (General) J Political Science > JF Political institutions (General)
ISSN:	0168-8510
Publisher:	Elsevier Science Direct
Language:	English
Submitter:	Katharina Blankart
Date Deposited:	24 Sep 2024 14:57
Last Modified:	24 Sep 2024 14:57
Publisher DOI:	10.1016/j.healthpol.2024.105164
Related URLs:	https://www.sciencedirect.com/journal/he...
Uncontrolled Keywords:	Medical Device Regulation Regulatory reliance Regulatory pluralism Innovation Patient pafety Security of supply
ARBOR DOI:	10.24451/arbor.22526
URI:	https://arbor.bfh.ch/id/eprint/22526