Not Quite the Same: Regulatory Intermediaries in the Governance of Pharmaceuticals and Medical Devices

Abstract

This article compares the role of regulatory intermediaries in the governance of pharmaceuticals and medical devices in Australia and Switzerland. We argue that the creation, selection, and activation of specific intermediaries depend on the organizational capacity of the regulator and on the capture potential of the target. To limit the risk of capture of intermediaries where the regulated industries are powerful, regulators tend to keep intermediaries under their control. To do so, the regulator must be well-funded and well-staffed, or supported by its political principal. However, when the target has limited capture potential, regulators will rely more heavily on externalized intermediaries. These intermediaries typically consist of transnational organizations in charge of multiple regulatory issues in several jurisdictions, and can provide unique expertise in an efficient way. Four case studies of the Australian and Swiss regulatory regimes for therapeutic products support this argument.

Keywords: health policy, regulatory agencies, regulatory intermediaries, therapeutic products, Australia, Switzerland, regulatory governance