Protecting Trade Secrets Under International Investment Law: What Secrets Investors Should Not Tell States

Abstract

The article addresses specifics of trade secret protection under international investment law. As a particular example, it analyzes protection of pharmaceutical regulatory data against the background of the growing public policy campaign for broader access to clinical trial data and the recent unprecedented practice of the European Medicines Agency of disclosing clinical dossiers submitted for drug marketing approval. Given the significant role of foreign direct investment in the global pharmaceutical industry and substantial, exponentially increasing costs incurred by drug originator companies in conducting clinical trials, the prospect of investor-state dispute over data disclosure does not appear purely hypothetical. The question is whether investor-state arbitration is an apt instrument to protect originators’ data against disclosure by drug regulatory authorities. The analysis suggests that the application of standards of international investment protection depends on the specifics of information at issue, its value, and functions in investors’ commercial operations. With regard to pharmaceutical test data, it is argued that the prospects of investor-state arbitration are rather unfavorable for the investor, when data is disclosed to support policy objectives in public healthcare and medical innovation.

Keywords: Clinical trial data; pharmaceutical foreign direct investment; investor-state arbitration; intellectual property; investment law

JEL Classification: O34