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Competition of regulatory ecosystems in approving medicines: Policy Implications in the case of Europe

Franco, P. & Haefliger, S. ORCID: 0000-0003-4207-9207 (2025). Competition of regulatory ecosystems in approving medicines: Policy Implications in the case of Europe. Drug Discovery Today, 30(2), article number 104295. doi: 10.1016/j.drudis.2025.104295

Abstract

The competition between business ecosystems is relevant not only for strategic management, but also for health policy and regulators. Regulation is one key factor in ecosystem competition, and government and regulatory bodies implement new pharmaceutical legislations, policies, and guidelines contributing to business environments capable of attracting startups, biotech firms, and pharmaceutical industry investments in innovative medicines and technologies. Implications for patients and societal welfare require a thorough analysis of strategies aimed at enhancing the competitive advantage of the European Union (EU) in attracting pharmaceutical companies to prioritize the submission of their innovative medicines. This analysis is essential for ensuring that patients have timely access to new treatments, that society benefits from advances in healthcare, and could foster the competitive advantage of the European regulatory ecosystem. Here, we present data from 47 interviews with pharmaceutical industry professionals, offering direct insights into regulatory ecosystem competition and global health policy. Our report underscores the necessity for effective strategies that enhance the competitive advantage of the European regulatory system.

Publication Type: Article
Additional Information: © 2025. This manuscript version is made available under the CC-BY-NC-ND 4.0 license https://creativecommons.org/licenses/by-nc-nd/4.0/
Publisher Keywords: competition, regulatory policy, regulatory ecosystems, regulatory bodies, pharmaceutical legislation, pharmaceutical regulation, regulatory system, FDA, EMA, national regulatory authority, pharmaceutical industry, startups, biotech firms, innovation, innovative medicines, medicines, health policy, strategic management, competitive advantage and incentives, business ecosystems, healthcare
Subjects: H Social Sciences > HB Economic Theory
R Medicine > R Medicine (General)
R Medicine > RS Pharmacy and materia medica
Departments: Bayes Business School
Bayes Business School > Management
SWORD Depositor:
[thumbnail of Revision_Draft_Drug_Discovery_Today_acceptedVJan13.pdf] Text - Accepted Version
This document is not freely accessible until 17 January 2026 due to copyright restrictions.
Available under License Creative Commons Attribution Non-commercial No Derivatives.

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