Drug Evaluation Committee 2013-35 Compensation for Injuries to Health and Adverse Reactions in Post-Marketing Clinical Trials
Related classification: Other
Initial release date: November 2013
Revised release date: March 2021
Question
This is a question regarding Q29 of the "Revision of Questions and Answers (Q&A) on Notification of a Clinical Trial Plan and Conduct of a Clinical Trial for a Drug" issued on December 9, 2020.
According to the Q&A, it appears that the Adverse Reaction Relief System does not provide any compensation for health damage in post-marketing clinical trials. I understood that in post-marketing clinical trials, the line is drawn as to whether or not the so-called white box (white label) is used. Should we change this concept of compensation in post-marketing clinical trials that are currently being conducted or will be conducted in the future? Also, should it be interpreted that even in trials in which marketed drugs are used as is, all compensation will be provided by the sponsor's insurance or other measures?
Opinion of the Pharmaceutical Manufacturers Association of Japan
The Adverse Reaction Damage Relief System for Pharmaceuticals is a system that aims to provide relief to victims of certain health problems caused by adverse reactions to pharmaceuticals despite their proper use by providing benefits such as medical expenses. Eligible drugs are those prescribed by medical institutions or purchased at pharmacies, and post-marketing clinical trial drugs are not eligible.
The sponsor of a post-marketing clinical study must provide, in advance, insurance and other necessary documents to compensate for any damage to the health of subjects involved in the post-marketing clinical study (including those caused by the contractor's work). The post-marketing clinical trial sponsor must take necessary measures in advance, such as insurance, to compensate for health damages (including those caused by the contractor's work) to subjects involved in post-marketing clinical trials (GCP Article 14). In other words, regardless of whether or not a white box (a post-marketing clinical trial drug manufactured and packaged for the study, not a product) is used, compensation for health damage caused by post-marketing clinical trials is not covered by the Adverse Reactions Relief System, and must be handled by the post-marketing clinical trial sponsor.
Reason for revision of opinion
In line with the issuance of the "Revision of Questions and Answers (Q&A) on Notification of Clinical Trial Plan and Conduct of Clinical Trial for Drugs" (December 9, 2020, Ministry of Health, Labour and Welfare, Pharmaceuticals and Welfare Bureau, Drug Evaluation and Control Division), minor changes have been made in the questions.