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.

• doi: 10.1016/j.stemcr.2022.03.015