ABSTRACT
Who would have thought that Japanese patients have fewer chances to benefit from medical innovation than Americans and Europeans? The answer is hardly anybody. Most people in the West think of Japan as a technologically advanced society and as an equal to the United States and Europe. Why this is not the case in clinical medicine, clinical evaluation, and treatment capabilities of innovative medical devices in Japan, and how the government has responded to these conditions substantively, was the subject of this study. For a technologically advanced country like Japan, the discovery that medical technology, medical innovations, and clinical research were underdeveloped, and that patients had limited or delayed access to advanced treatments and procedures when compared to Europe and the United States, presents a number of paradoxes. This study sought to unravel them and go to their root causes so that I could explain how and why Japanese patients did not benefit from medical innovations like their European and American cousins. The study focused on medical device regulation during a period of dramatic changes, domestically and on a global scale. That domestic reform of an entrenched regulatory system moved slowly, and then only in response to pressures from an increasingly competitive international environment, is not unusual given the clash between rhetorical intent and actual implementation of regulatory policies.
