NOBLE HUMBUG? HARD AND SOFT LAWS ON CLINICAL PLACEBO USE

Mélina Richard ^1* Lena Dominique Hornstein ¹ Manuela Ganz ¹ Bohdan Stehlik ¹ Melanie Levy ² Charlotte Blease ^3,4 Marco Annoni ⁵ Bernice S. Elger ¹ Jens Gaab ¹

• ¹ University of Basel, Basel, Switzerland
• ² Faculté de droit, Université de Neuchâtel, Neuchâtel, Neuchâtel, Switzerland
• ³ Uppsala University, Uppsala, Uppsala, Sweden
• ⁴ Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States
• ⁵ National Research Council (CNR), Roma, Lazio, Italy

Despite the widespread historical and contemporary use of placebos in medicine, legal regulations addressing their administration remain limited in many countries. This invites the need for a comprehensive exploration of the legal landscape surrounding placebo use. In this paper, we focused on analyzing the legal frameworks on clinical placebo use in key jurisdictions such as France, Germany, Switzerland, the United Kingdom, and the United States of America.Methodologically, this investigation into the legal landscape of placebo use involves a multidisciplinary approach, including a detailed examination of both binding laws ("hard laws") and non-binding principles ("soft laws") related to placebo use. We collected and analyzed data from legal documents, health institution guidelines, and other sources to map how placebos are regulated under different legal systems. This approach helps map out the complex terrain of placebo use in healthcare, highlighting diverse practices and legal considerations: For instance, in Germany and the UK, while there are no laws specifically addressing placebos, their use is regulated indirectly through statutes that require informed consent for medical procedures. These countries mandate that patients must be informed about the nature of their treatments, implicitly covering placebo interventions. In the United States, the American Medical Association has set forth guidelines that allow the use of placebos under strict conditions that prioritize patient welfare and transparent communication.Legal implications of unauthorized placebo use can include charges of medical fraud or violations of patient rights, emphasizing the need for explicit regulatory guidelines. The potential legal and ethical risks underline the importance of maintaining rigorous standards of consent and disclosure in the use of placebos.The ongoing debate and the evolving legal and ethical frameworks call for a critical reassessment of how placebos are perceived and utilized in medical practice. The introduction of open-label placebos (OLPs) and the growing body of research supporting their efficacy without deception provide a promising avenue for reconciling ethical concerns with clinical applications. These developments indicate the need for revisions in legal and ethical regulations to explicitly address the use of all forms of placebos, ensuring that their deployment in healthcare is both responsible and respectful of patient autonomy.