Risk Regulation and Innovation: The Case of Rights-Encumbered Biomedical Data Silos

Abstract

Recent Supreme Court cases on patent-eligible subject matter are likely to exacerbate the longstanding problem of biomedical data fragmentation. For each data silo, multiple overlapping legal claims and claimants must be addressed to achieve the benefits of pooling.

Commentators who have discussed the data aggregation challenge have generally focused on possibilities created through public funding, through collective action by research participants, or through pressure by payers. This Article emphasizes the important role of risk regulators, most notably the precedent offered by risk regulation in the area of clinical trial data.

While U.S. risk regulators have taken some positive steps, the recent actions of their European counterpart, the European Medicines Agency (EMA), have been particularly creative. Indeed, because data is a global public good, the EMA's actions create a global baseline for access. Private-sector data pooling spurred by threats of regulatory action is also a positive development. Finally, in those advanced economies that have such exclusivity, data exclusivity that runs concurrently with any patents emerges as an attractive mechanism for balancing the interests of initial and subsequent data generators.

In elucidating the role of risk regulators, this Article contributes another chapter to the rich legal and economic literature discussing whether, and how, risk and social regulation can promote socially valuable innovation. As contrasted with much of this literature, however, the Article focuses not on innovation induced by efforts to comply with regulation but instead on regulation as a force for creating a data infrastructure for future innovation.

Keywords: global public good, data pooling, clinical trial data, regulation, EMA