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ORIGINAL RESEARCH article

Front. Pharmacol.

Sec. Drugs Outcomes Research and Policies

Volume 16 - 2025 | doi: 10.3389/fphar.2025.1547418

Off-Label Drug Use in China After the Physician Law (2021): Legal Challenges and Solutions

Provisionally accepted
Shenbao Liang Shenbao Liang *Fanxian Cai Fanxian Cai
  • Shanghai University of Finance and Economics, Shanghai, China

The final, formatted version of the article will be published soon.

    This article examines the current state of off-label drug use in China, and the legal liability risks faced by medical institutions. In 2021 China enacted the Physician Law, which specifically outlines the legal requirements for off-label drug use in Article 29. Legislators, medical institutions, and judicial authorities all hoped that this new regulation would effectively reduce illegal off-label drug use. However, many violations still occurred in medical practice even after the enactment of the Physician Law, leading to judicial cases. This article analyses relevant data and identifies three main forms of non-compliant off-label drug use: first, insufficient evidence-based justification; second, deficiencies in the informed consent process; and third, the lack of an internal review system. These are also the primary factors leading to legal liability for medical institutions. From a legal doctrinal perspective, the article concludes by elaborating on how each legal requirement should be met. Our research provides insights into the factors that lead to legal liability for off-label drug use and examines how physicians and medical institutions can avoid such liability.

    Keywords: off-label drug use, evidence-based support, Informed Consent, Internal review procedure, Medical liability

    Received: 18 Dec 2024; Accepted: 27 Mar 2025.

    Copyright: © 2025 Liang and Cai. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Shenbao Liang, Shanghai University of Finance and Economics, Shanghai, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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