Do Physicians Have a Duty to Discuss Expanded Access to Investigational Drugs with their Patients? A Normative Analysis

J Law Med Ethics. 2023;51(1):172-180. doi: 10.1017/jme.2023.53. Epub 2023 May 25.

Abstract

Drawing on ethical and legal frameworks in the Netherlands, the United States and France, we examine whether physicians are expected to inform patients about potentially relevant opportunities for expanded access to investigational drugs. While we found no definitive legal obligation, we argue that physicians have a moral obligation to discuss opportunities for expanded access with patients who have run out of treatment options to prevent inequality, to promote autonomy, and to achieve beneficence.

Keywords: Expanded Access; Investigational Treatments; Moral Obligations; Professional Obligations; Shared Decision Making; Treatment Options.

MeSH terms

  • Beneficence
  • Drugs, Investigational* / therapeutic use
  • France
  • Humans
  • Moral Obligations
  • Physicians*

Substances

  • Drugs, Investigational