2018 Volume 28 Issue 1 Pages 37-48
In Japan, article 18 of the“ Rules for Health Insurance-covered Medical Facilities and Medical Practitioners” stipulates“ health insurance-covered physician should not conduct special therapies or new therapies other than those specified by the Minister of Health, Labour and Welfare”. In principle, it is impossible to conduct medical insurance treatment when using pharmaceuticals or medical devices not approved in Japan. As an exception, there is an evaluation treatment such as Advanced Medical Care and clinical trials in the medical expenses combined with treatment outside insurance coverage. A new system such as “Compassionate Use Program” and “Patient-Proposed Healthcare Services” have started since 2016 so that patients who have difficulty accessing state-of-the-art medical technologies or pharmaceuticals under the existing system, quickly can ensure access to such technologies. More than one year has elapsed since these systems were started, after explaining the outline of each system, we will refer to the current situation and issues of both systems.
