The Transatlantic Clinical Trial Transparency Gap

Authors

Gabriela Lenarczyk, University of Copenhagen

Abstract

Clinical trial data occupy a contested space between private commercial assets and public goods. While the United States Food and Drug Administration (FDA) has historically shielded these data through expansive trade-secret interpretations, the European Union (EU) has adopted a more open disclosure regime. This Article compares the two regimes and traces how the EU’s two-decade journey toward transparency has become a key reference for researchers and advocates of open data-sharing.

Focusing on EU practices—targeted redactions, time-bound access, granular disclosure guidelines—the paper shows that U.S. objections to broader transparency often rest on overstated concerns about competitive harm. A Filspari (sparsentan) case study underscores the paradox of data deemed confidential in America yet freely accessible in Europe. Continued reliance on the Freedom of Information Act (FOIA) perpetuates systematic non-disclosure in the U.S., despite both the availability of proactive publication mechanisms and these same pharmaceutical companies’ compliance with more transparent EU mandates.

Drawing on doctrinal, policy, and judicial developments, the paper explains how the FDA can use existing authority to shift from secrecy to transparency without compromising intellectual property. Nuanced redactions, category-specific guidelines, and recognition of the temporal nature of data sensitivity would align U.S. practice with tested European approaches. These reforms would reduce research duplication, strengthen evidence-based medicine, and reinforce foundations of pharmaceutical regulation, without requiring Congressional action.

Recommended Citation

Gabriela Lenarczyk, The Transatlantic Clinical Trial Transparency Gap, 33 J. Intell. Prop. L. 32 (2026).
Available at: https://digitalcommons.law.uga.edu/jipl/vol33/iss1/3