ABSTRACT
This chapter addresses how the intentions of the Pharmaceutical Affairs Law (PAL) are translated into action and how PAL is experienced by officials and business. PAL is embedded in a path-dependent institutional and organizational environment, but it also introduces novel elements of policy and law. The chapter is divided into two parts. The first begins by tracing the historical trajectory of the regulation, and how and why it was possible to enact the Pharmaceutical Affairs Law (PAL) in 2005, despite persistent structural constraints in Japan. To do so, the chapter identifies the main drivers of change and then explores the political circumstances that brought about change. After a brief sketch of the political conditions, public opinion, and a widespread distrust toward physicians, the chapter also lays out the objectives of the PAL and the formal building blocks of medical device regulation. In the second section, I offer several narratives and anecdotes, based on interviews, to shed light on the enforcement and implementation de jure and de facto. In this context, it will become clear how and why medical technology regulation in Japan differs from that in the United States and the EU.
