Avoiding the TRIPS Trap: A Path to Domestic Disclosure of Clinical Drug Data Consistent with International Norms

Abstract

Should doctors, patients and policy makers have complete information about new drugs? Although complete transparency may seem like the obvious answer, the reality is that publicly available information is often incomplete. Before a drug may be approved for sale, a regulatory agency such as the Food and Drug Administration (FDA) will review extensive data created by a company seeking approval of such a drug. However, the FDA considers such information to be protected from public disclosure as a commercially confidential trade secret. In the United States, scientific papers concerning new drugs are often based on proprietary data and published articles often present skewed results compared to the complete data possessed by the FDA. The implications of articles based on proprietary data typically get short shrift. However, two articles on Covid-19 were recently retracted after independent scientists questioned the conclusions and the authors admitted that the articles were based on proprietary data that could not be verified, leading to their retraction. Although the intense public spotlight on Covid-19 highlighted this problem, doctors are generally forced to rely on incomplete information based on similar proprietary data in making prescribing decisions. This unnecessarily compromises patient health and safety. Although the EU and Canada have recognized the public health benefit of more transparency and increased publication of clinical data for new drugs, understudied aspects of international intellectual property laws may limit disclosure. In particular, all member countries of the World Trade Organization (WTO), including Canada and the EU member states, must comply with certain intellectual property minimum requirements, including one that governs the data at issue. Article 39(3) of the Trade Related Intellectual Property Agreement (TRIPS) requires WTO countries to protect data submitted to regulatory agencies from “uncommercial fair use.” This highly contested term has never been definitively clarified in the WTO’s dispute settlement process. Moreover, TRIPS permits countries to disclose such data under one of two exceptions that have been largely ignored in the literature so far. This Article provides the first comprehensive analysis of whether domestic disclosure of clinical data is permissible under either of these two exceptions. In doing so, this Article contributes to broader policy issues. First, although some policy makers have long recognized that international obligations may constrain domestic options, this Article provides a concrete case study of the dangers of creating new international intellectual property norms—especially when such norms are created by a select group of stakeholders that may not represent all interests. This is a timely and important issue since nations have generally been entering into international agreements with increasing levels of intellectual property rights since the conclusion of the WTO. Second, the Article suggests actions to consider in both the domestic and international contexts regarding clinical data, including specific suggestions to improve clinical data disclosure in the United States.