Restrictions on monetary payments for human biological substances in Japan: The mu-shou principle and its ethical implications for stem cell research

Yusuke Inoue; Tohru Masui; Kana Harada; Hyunsoo Hong; Minori Kokado

doi:10.1016/j.reth.2023.02.004

Restrictions on monetary payments for human biological substances in Japan: The mu-shou principle and its ethical implications for stem cell research

Regen Ther. 2023 Mar 9:23:1-7. doi: 10.1016/j.reth.2023.02.004. eCollection 2023 Jun.

Authors

Yusuke Inoue¹, Tohru Masui², Kana Harada¹, Hyunsoo Hong³, Minori Kokado⁴

Affiliations

¹ Department of Public Policy, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan. 4-6-1 Shirokanedai, Minato-ku, Tokyo 168-8639, Japan.
² Center for Medical Genetics, Keio University School of Medicine, Tokyo, Japan. 35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582, Japan.
³ Division of Bioethics, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan. 4-6-1 Shirokanedai, Minato-ku, Tokyo 168-8639, Japan.
⁴ Faculty of Pharmacy, Kobe Pharmaceutical University, Hyogo, Japan. 4-19-1 Motoyamakita, Higashinada, Kobe 658-8558, Japan.

Abstract

Introduction: Restrictions on financial gains from the sale of human body parts is a leading policy issue surrounding the use of human tissues and cells. However, discrepancies exist between regulations and reality. In stem cell research, in which diverse sources of tissues and cells can be used, unclear regulations can impede research. Thus, using the Japanese system as a case study, we examined the challenges in the implementation of the "no payment" or the mu-shou principle in stem-cell research over the years.

Methods: We reviewed 28 Japanese laws and governmental guidelines and summarized the scope of restrictions on payments for the donation and supply of human biological samples (HBS).

Results: As part of restrictions on financial rewards, the mu-shou principle emerged in Japanese laws and administrative documents in the 1990s. Although the Japanese mu-shou generally means "free" or "gratis" in English, its interpretation in research and development settings remains ambiguous. Traditionally, this principle was used to deny remuneration to donors. However, it is also inconsistently applied while processing and transferring human tissue after donation, which creates confusion among the various stakeholders. Recent policies have interpreted the principle in multiple ways: (1) treating the use of HBS for cell-processing as a non-profit activity; (2) a flexible interpretation of the principle to broaden the scope of user payments; and (3) removal of the principle itself to allow for commercial use.

Conclusions: The inconsistencies in the monetary payment requirements for HBS could hinder research and development. After scrutinizing the principle's background, an effective approach is needed that considers the concerns of the providers, users, and society alike.

Keywords: Donation; ES, Embryonic stem; Ethics; Financial gain; HBS, human biological sample; ISSCR, International Society for Stem Cell Research; METI, Ministry of Economy Trade and Industry; MEXT, Ministry of Education Culture Sports Science and Technology; MHLW, Ministry of Health Labor and Welfare; Payment; R&D, research and development; Stem cell research; mu-shou principle.