Legal Considerations for "Non-Evidence-Based Medicine"

2023 Fiscal Year Final Research Report

• Project/Area Number: 21K13221
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 05070:New fields of law-related
• Research Institution: Kanagawa University
• Principal Investigator: KOTANI Masako 神奈川大学, 法学部, 准教授 (80638916)
• Project Period (FY): 2021-04-01 – 2024-03-31
• Keywords: 自由診療規制 / EBM / 科学的根拠に乏しい診療 / 医師患者関係

Outline of Final Research Achievements

In this study, I examined "Non-Evidence-Based Medicine" provided by physicians to cancer patients. In Japan, the ex ante regulation of medical practice is very modest. In addition, medical care provided without public health insurance coverage is rarely regulated. What kind of legal measures could be taken against "Non-Evidence-Based Medicine"?
First, patients who have received such medical care may file a claim for damages against the physician or medical institution. However, this study analyzed cases and found that in many cases, the amount of damages is inadequate. Second, we examined the possibilities for ex ante regulation and the desirability of ex post regulation, taking into consideration the situations in other countries. Third, how would the medical policy be determined in such a case? I reconsidered the legal obligations that physicians have to their patients in such a situation.

Free Research Field

医事法

Academic Significance and Societal Importance of the Research Achievements

近時、自由診療のうち科学的根拠に乏しいもの（がんに対するものだけでなく、再生医療なども含む）などに関する報道がなされるようになっており、本研究で取扱った問題が社会的な問題として認識されつつある。　本研究は、このような社会状況にあって、がんに対する自由診療に限定してはいるものの、いかなる法的対応が有効であるかに関し考察し、見解を示した。
また、これまでの医師患者関係や意思の裁量といった伝統的な医事法の論点についても、自由診療に関する患者の強い希望がある場合の医師の法的義務などについて、異なる視座に立ちつつ考察し、新たな理論の展開の可能性を示唆した。