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Asia: Japan’s PMDA calls for support to help patients claim compensation for adverse drug reactions

2023/11/14  PMDA

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is asking health care professionals to help ensure patients who are harmed by medicines can access the Relief System for Adverse Drug Reactions.

The Relief System, which was established in 1980, is designed to provide compensation to patients who suffer adverse health effects, such as disorders or disabilities, caused by adverse reactions to drugs despite proper use. From its establishment through the end of Fiscal Year 2022, a total of 29,014 cases were granted relief via the system, which is funded through contributions from marketing authorization holders.

However, most people remain unaware of the system. A 2022 survey of the general public found just 11.2% of people “were aware” of the Relief System and 24.9% had “heard about” the system. The figures have caused concerns at PMDA.

“It is inferred that some people may not file an application for compensation for adverse health effects associated with ADRs that they have suffered because they are unaware of the Relief System,” PMDA wrote in its November information publication.

PMDA is looking to health care professionals to help ensure more patients file for compensation. Awareness of the system is higher among health care professionals, with 83.8% of surveyed providers having some level of knowledge of the compensation mechanism.

The Japanese drug regulator added a field for information on the Relief System to the form that health care professionals use to report adverse drug reactions in 2014. PMDA is now asking health care professionals to consider introducing the Relief System to the patient when reporting adverse events.

Increasing awareness of the system could counteract the trend of decreasing relief claims. From 2019 to 2022, the number of applications for relief fell by 23% to 1,230. The annual number of applications for relief has fallen each year since 2019.

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