Overview of the Relief System for Adverse Health Effects and Organizational Issues

Abstract

The Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for the services regarding the operation of the Relief System for Adverse Health Effects to provide swift relief to sufferers from adverse health effects caused by adverse drug reactions by paying out benefits to them. This service is one of the three pillars of the PMDA’s activities, along with reviews, including related services, and safety measure services. In FY 2021, a total benefit of 2,376 million yen was provided for about 1,400 claims. The historical background to the establishment of the system is a bitter experience of large-scale drug-induced cases such as thalidomide and subacute myelo-optico-neuropathy (SMON). In addition to strengthening safety measures in pharmaceutical regulatory affairs, a unique scheme separate from the conventional legal liability theory was required to provide swift relief to sufferers from adverse health effects in a realistic manner. Under these circumstances, the Relief System for Sufferers from Adverse Drug Reactions was launched in 1980 after deliberation in the Diet. In 2004, the Relief System for Infections Acquired through Biological Products was added to the system. This relief system is currently being implemented after improvements in the organizational structure and other modifications. Of the issues to be addressed, “the operational issues of the system” will be improved in response to the recommendations of the “Study Group on the Operational Improvement of the Relief System for Adverse Health Effects.” Improvement measures have been included in the PMDA annual plan. For “the organizational management issues for the service operator” from the perspective of organizational and human resource management, the PMDA is seeking better management strategies, including how to motivate staff with responsibilities for services to achieve results.