Ethics of Expanded Access During the COVID-19 Pandemic

Abstract

During the COVID-19 pandemic, investigational treatments have been made available to seriously ill patients through so-called expanded access programmes, such as compassionate use and named-patient programmes. Many countries have legal, ethical and professional frameworks in place to promote safe and responsible use of investigational treatments outside of clinical trial settings. However, these frameworks leave room for ambiguities regarding the roles and responsibilities of treating physicians, hospital-based pharmacists, pharmaceutical companies, and other stakeholders, and for practices to differ, not only between countries, but also within countries, between hospitals and individual healthcare providers. Current ambiguities with regard to physicians’ moral duties, for instance, allow physicians to withhold information from patients about options for expanded access, and to forego pursuing such options for their patients. This chapter describes the experiences with the use of Remdesivir and hydroxychloroquine in COVID-19-infected patients in the Netherlands during the first wave of the pandemic, and discusses an open question in relation to treating physicians’ duties, namely vis-à-vis information provision. This chapter proposes a prima facie obligation for healthcare professionals to inform eligible patients about relevant options for expanded access.