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April 25, 2022

Financial risks posed by unproven cell interventions in Japan

The research group led by Professor Misao Fujita conducted a study to estimate the total amount of refund the Japanese government would pay if a patient received unproven cell interventions and applied for a medical expense deduction.

Some regenerative medicines whose safety and efficacy have not been fully confirmed in clinical trials and other studies are offered as treatments for patients. Some of the unproven treatments are expensive, and it has been pointed out that there is an economic risk to patients in addition to the risk of health problems.

The research team wondered if there might be a financial risk that the government (i.e., the public) would bear part of the costs for the medical treatment for which scientific evidence is unclear, through the tax system of refunds based on deductions for medical expenses. Therefore, in this study, they estimated the total amount of refunds paid by the government for unproven cell interventions in Japan, with the aim of presenting empirical data on the financial risk.

The results of this study provide new insight into the financial risks associated with scientifically unproved regenerative medicine. In other words, regenerative medicine treatments provided outside the public health insurance system has financial risks that go beyond the personal and private relationship between the physician/medical institution and the patient, which is a problem for the society.

The researchers believe it is necessary for the government to take responsibility for guaranteeing the safety and efficacy of regenerative therapies provided outside the public health insurance system, and to further discuss how to respond to the problem by considering a revision of the Act on the Safety of Regenerative Medicine.

The study was published online in "Stem Cell Reports" on April 21, 2022.

Paper Details
  • Journal: Stem Cell Reports
  • Title: Financial risks posed by unproven cell interventions: Estimation of refunds from medical expense deductions in Japan
  • Authors: Taichi Hatta1, Kazuki Ide2,3, Misao Fujita4,5,* and Tsunakuni Ikka6
    *Corresponding author
  • Author Affiliations:
    1. Shizuoka Graduate University of Public Health
    2. Division of Scientific Information and Public Policy, Center for Infectious Disease Education and Research, Osaka University
    3. Research Center on Ethical, Legal and Social Issues, Osaka University
    4. Uehiro Research Division for iPS Cell Ethics, Center for iPS Cell Research and Application (CiRA), Kyoto University
    5. Institute for the Advanced Study of Human Biology (WPI-ASHBi), KUIAS Kyoto University
    6. National Cancer Center Japan, Institute for Cancer Control, Division of Bioethics & Healthcare Law
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