Richard Mélina, Ganz Manuela, Hornstein Lena Dominique, Stehlik Bohdan, Levy Mélanie, Blease Charlotte R, Annoni Marco, Elger Bernice S, Gaab Jens
Institute of Biomedical Ethics, University of Basel, Basel, Switzerland.
Department of Biomedical Engineering, University of Basel, Basel, Switzerland.
Front Psychol. 2025 Mar 12;16:1520664. doi: 10.3389/fpsyg.2025.1520664. eCollection 2025.
Despite the widespread historical and contemporary use of placebos in medicine, legal regulations addressing their administration remain limited in many countries. This paper examines the legal landscape of clinical placebo use, focusing on key jurisdictions such as France, Germany, Switzerland, the United Kingdom, and the United States. Given the ethical and legal complexities surrounding placebo use, a critical assessment of existing regulatory frameworks is essential. This study employs a multidisciplinary approach, analyzing both binding laws ("hard laws") and non-binding principles ("soft laws") related to placebo administration. Data were collected from legal statutes, health institution guidelines, and professional medical codes to map the regulatory environment governing placebos in different legal systems. The results indicate significant variations in how placebos are addressed legally. For instance in Germany and the UK, no specific laws regulate placebo use, but statutes on informed consent implicitly cover their administration. In the United States, the American Medical Association provides ethical guidelines permitting placebo use under strict conditions emphasizing patient welfare and transparency. Across all examined jurisdictions, unauthorized placebo use may lead to legal consequences such as medical fraud allegations or violations of patient rights. These findings highlight the need for explicit regulatory guidelines to ensure that placebo use adheres to ethical and legal standards. The growing acceptance of open-label placebos (OLPs), which demonstrate efficacy without deception, presents a potential avenue for aligning legal frameworks with evolving medical practices. Future regulatory developments should address the ethical and legal challenges associated with placebos, ensuring patient autonomy and informed consent remain central to their use in clinical practice.
尽管安慰剂在医学上有着广泛的历史和当代应用，但在许多国家，针对其使用的法律法规仍然有限。本文考察了临床使用安慰剂的法律状况，重点关注法国、德国、瑞士、英国和美国等关键司法管辖区。鉴于围绕安慰剂使用的伦理和法律复杂性，对现有监管框架进行批判性评估至关重要。本研究采用多学科方法，分析与安慰剂使用相关的具有约束力的法律（“硬法”）和不具有约束力的原则（“软法”）。数据收集自法律法规、卫生机构指南和专业医学规范，以描绘不同法律体系中管理安慰剂的监管环境。结果表明，在安慰剂的法律处理方式上存在显著差异。例如，在德国和英国，没有具体法律规范安慰剂的使用，但关于知情同意的法规隐含地涵盖了其使用。在美国，美国医学协会提供了伦理指南，允许在严格条件下使用安慰剂，强调患者福利和透明度。在所有考察的司法管辖区，未经授权使用安慰剂可能会导致法律后果，如被指控医疗欺诈或侵犯患者权利。这些发现凸显了制定明确监管指南的必要性，以确保安慰剂的使用符合伦理和法律标准。公开标签安慰剂（OLP）越来越被接受，它在不欺骗的情况下显示出疗效，这为使法律框架与不断发展的医疗实践保持一致提供了一条潜在途径。未来的监管发展应应对与安慰剂相关的伦理和法律挑战，确保患者自主权和知情同意在临床实践中使用安慰剂时仍然是核心要素。
