Paper short abstract:

The paper elaborates how safety is understood and established in processes of medical device approval in Japan. It argues that the value-based concept of anshin (reassurance) beside the science-based one of anzen (avoidance of danger) resulting in difficulties to balance safety and bearable risks.

Paper long abstract:

The Japanese government underlines medical technologies as one focus area to achieve a "healthy and active ageing society as a top-runner in the world" (Innovation 25, Comprehensive STI Strategy). Basically, medical instruments can be used to manipulate the human body, ranging from general devices with extremely low risk to such ones highly invasive to patients. This leads to the question how safety is understood and established in processes of medical device approval in Japan. Over the past years, the scholarship in and outside Japan regularly pointed to the so-called "device lag", which allegedly was caused by a dominating focus on safety at the cost of those patients in urgent need for enhanced treatments. Several authors levelled criticism that this circumstance did not only inhibit innovation but also access to cutting-edge technology, referring to the patient right argument. In 2014, the legislation changed in Japan and approval processes were re-organised by establishing the PMDA (Pharmaceutical and Medical Device Agency). However, voices remain that the PMDA is still facing high public expectation of safety standards defined as "the absence of risks" whereas, in the EU and US, the concept of safety as "avoidance of non-acceptable risks" is more common (Kishimoto 2016). Thus, I argue in this paper that beside the science-based perception (anzen) the value-based concept of anshin (reassurance) develops wide influence causing politicians to put further reforms on a hold. More precisely, PMDA officials seem to continuously have difficulties in balancing safety and bearable risks due to the political nature of discussing safety in medical contexts in Japan. To analyse the ambivalent perception of safety in this context, this paper draws on preliminary results from an interview study conducted in 2016 in Japan.