Noble Humbug? Hard and soft laws on clinical placebo use
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...
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Frontiers Media S.A.
2025-03-01
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| Series: | Frontiers in Psychology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyg.2025.1520664/full |
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| author | Mélina Richard Mélina Richard Manuela Ganz Lena Dominique Hornstein Bohdan Stehlik Mélanie Levy Charlotte R. Blease Marco Annoni Bernice S. Elger Jens Gaab |
| author_facet | Mélina Richard Mélina Richard Manuela Ganz Lena Dominique Hornstein Bohdan Stehlik Mélanie Levy Charlotte R. Blease Marco Annoni Bernice S. Elger Jens Gaab |
| author_sort | Mélina Richard |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-3e393d50f7a3427ea8a216f500c51682 |
| institution | DOAJ |
| issn | 1664-1078 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychology |
| spelling | doaj-art-3e393d50f7a3427ea8a216f500c516822025-08-20T02:59:06ZengFrontiers Media S.A.Frontiers in Psychology1664-10782025-03-011610.3389/fpsyg.2025.15206641520664Noble Humbug? Hard and soft laws on clinical placebo useMélina Richard0Mélina Richard1Manuela Ganz2Lena Dominique Hornstein3Bohdan Stehlik4Mélanie Levy5Charlotte R. Blease6Marco Annoni7Bernice S. Elger8Jens Gaab9Institute of Biomedical Ethics, University of Basel, Basel, SwitzerlandDepartment of Biomedical Engineering, University of Basel, Basel, SwitzerlandDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, SwitzerlandDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, SwitzerlandDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, SwitzerlandHealth Law Institute, Faculty of Law, University of Neuchâtel, Neuchâtel, SwitzerlandParticipatory eHealth and Health Data Research Group, Uppsala University, Uppsala, SwedenCentre for Research Ethics and Integrity (CID-Ethics), National Research Council (CNR), Rome, ItalyInstitute of Biomedical Ethics, University of Basel, Basel, SwitzerlandDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, SwitzerlandDespite 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.https://www.frontiersin.org/articles/10.3389/fpsyg.2025.1520664/fullplaceboclinical placebo uselegal frameworksclinical regulationshard laws and soft lawsinformed consent |
| spellingShingle | Mélina Richard Mélina Richard Manuela Ganz Lena Dominique Hornstein Bohdan Stehlik Mélanie Levy Charlotte R. Blease Marco Annoni Bernice S. Elger Jens Gaab Noble Humbug? Hard and soft laws on clinical placebo use Frontiers in Psychology placebo clinical placebo use legal frameworks clinical regulations hard laws and soft laws informed consent |
| title | Noble Humbug? Hard and soft laws on clinical placebo use |
| title_full | Noble Humbug? Hard and soft laws on clinical placebo use |
| title_fullStr | Noble Humbug? Hard and soft laws on clinical placebo use |
| title_full_unstemmed | Noble Humbug? Hard and soft laws on clinical placebo use |
| title_short | Noble Humbug? Hard and soft laws on clinical placebo use |
| title_sort | noble humbug hard and soft laws on clinical placebo use |
| topic | placebo clinical placebo use legal frameworks clinical regulations hard laws and soft laws informed consent |
| url | https://www.frontiersin.org/articles/10.3389/fpsyg.2025.1520664/full |
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