TRIPS and disclosure of clinical information: An intellectual property perspective on data sharing

Abstract

Health scholars, lawyers, and social activists have greatly emphasized the social benefits of disclosure of clinical reports, that is, dossiers of drugs trials submitted to medical agencies in support of pharmaceutical authorizations. On their side, medical authorities are reluctant to divulge regulatory documents because they fear that they might contain commercial trade secrets of drug applicants. In these regards, the Agreement on Trade Related Aspects of Intellectual Property (TRIPS) prohibits trials disclosure except “where necessary to protect the public” or “unless steps are taken to ensure that the data are protected against unfair commercial use.” This paper delves into the complicacies of the TRIPS discipline to clarify the limits imposed by the treaty on medical agencies, and it goes on to suggest meaningful ways of complying with the TRIPS obligations while retaining most of the benefits associated with trials disclosure.