US-EU Regulatory Cooperation: Lessons and Opportunities
Unnecessary regulatory differences between countries persist as lingering barriers to trade even as traditional barriers are declining.
The George Washington University Regulatory Studies Center prepared this report as part of a grant from the European Union to analyze opportunities to improve regulatory cooperation between the EU and U.S. The first chapter presents an overview of the research. The case studies in chapters three through five examine how regulatory cooperation has worked in practice between three U.S. regulatory agencies and their EU counterparts. The fifth chapter analyzes regulatory activity in the U.S. likely to have significant effects on international trade and investment. These analyses identify areas of opportunity that can help reduce incompatible approaches and unnecessary costs while indicating areas where regulatory divergences could persist due to jurisdictional judgments of national sovereignty and structural differences between countries.
Download the individual working papers:
Introduction: Experiences in International Regulatory Cooperation: Benefits, Limitations, and Best Practices, by Daniel R. Pérez & Susan E. Dudley
Improving Regulatory Cooperation Between the U.S. Food and Drug Administration and the EU, by Randall Lutter & David Zorn
By Susan E. Dudley and Kai Wegrich
This paper aims to provide a descriptive analysis of procedural differences in regulatory development between the United States and the European Union to serve as a factual basis for understanding the regulatory challenges and opportunities for transatlantic trade. It summarizes regulatory procedures in each jurisdiction, dividing the process for establishing regulations into four stages: 1) agenda setting, 2) regulatory development, 3) final determination and opportunities for challenge, and 4) implementation and enforcement. After presenting the procedures in the U.S. and EU, the paper compares how the shared goals for achieving a regulatory system that is evidence based, transparent, and accountable are achieved in the two jurisdictions.