Competition of regulatory ecosystems in approving medicines: policy implications in the case of Europe.

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 65 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.