Drug Evaluation Committee 2007-07 Participation in Clinical Trials by Welfare Recipients
Related classification: Other
Date of first publication: August 2007
Question
I have heard that when a welfare recipient participates in a clinical trial, he/she has to consult with the insurance office about burden reduction expenses, special treatment expenses (medical treatment expenses not covered by insurance), etc. However, I have never actually had such an experience. If this is the case, what specific things should we pay attention to?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When welfare recipients participate in a clinical trial, consideration should be given to the socially vulnerable and the impact on the welfare system.
Consideration for socially vulnerable groups is mainly reviewed by the Clinical Trial Review Committee (GCP Article 32, Paragraph 1/Section 2, Guidance 1).
In addition, with regard to the impact on the public assistance system, receipt of the cost-sharing reduction allowance can be grounds for exclusion from public assistance or reduction of public assistance payments, and the uninsured combined medical care cost system cannot be applied in principle (Article 52, Paragraph 2 of the Public Assistance Act). Inquiries regarding these points should be made to the welfare office that has jurisdiction over welfare recipients. It is important to explain the expected payment costs to the welfare office and to coordinate with the hospital and the subject, and to take the most desirable measures for the subject after explaining that the amount of welfare benefits may be affected.