A New Framework for Assessing Clinical Data Transparency Initiatives

Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of their medicines, expecting the information to be kept confidential, as has been the practice of regulators around the world for decades. Over the last ten years, however, pressure has been mounting for regulators or industry to release this information. Legal scholars have generally taken the view that no relevant doctrines or bodies of law preclude the release of this material and that public policy considerations compel its release. This article argues that the scholarship to date has overlooked key considerations: the special issues presented by operation in a regulatory environment where the information good is generated to overcome a barrier to market, and the implications of operation in a multi-national environment where the decision of one regulator can have profound implications on legal outcomes in other jurisdictions. Further, it argues, use of the trade secret label — which most scholars and courts assume is the correct label for this information good — is analytically problematic. I argue that the issue should be assessed through a different lens: whether the drug manufacturers have a private property interest in the contents of their applications. I also argue that because this content has both informational uses and regulatory uses, the right to exclude includes severable rights to prevent disclosure and to prevent use. Disclosure to academics and other researchers — which I agree is important from a public health perspective — can be accomplished with restrictions on further disclosure and protection from regulatory use, thereby preserving some property right and arguably blunting the taking and reducing any compensation that might be owed. In view of the property right, however, the government should consider incentivizing or rewarding volunteerism. The risk that another regulator will move before the U.S. government may also call for consideration of reforms that will blunt the impact of disclosure on incentives to innovate