Medication of Hydroxychloroquine, Remdesivir and Convalescent Plasma during the COVID-19 Pandemic in Germany—An Ethical Analysis

Abstract

This paper aims to analyze the ethical challenges in experimental drug use during the early stage of the COVID-19 pandemic, using Germany as a case study. In Germany uniform ethical guidelines were available early on nationwide, which was considered as desirable by other states to reduce uncertainties and convey a message of unity. The purpose of this ethical analysis is to assist the preparation of future guidelines on the use of medicines during public health emergencies. The use of hydroxychloroquine, remdesivir and COVID-19 convalescent plasma in clinical settings was analyzed from the perspective of the ethical principles of beneficence, non-maleficence, justice and autonomy. We observed that drug safety and drug distribution during the pandemic affects all four ethical principles. We therefore recommend to establish ethical guidelines (i) to discuss experimental treatment options with patients from all population groups who are in urgent need, (ii) to facilitate the recording of patient reactions to drugs in off-label use, (iii) to expand inclusion criteria for clinical studies to avoid missing potentially negative effects on excluded groups, and (iv) to maintain sufficient access to repurposed drugs for patients with prior conditions.

A scoping review of ethics review processes during public health emergencies in Africa

“…The conduct of research -especially during a public health emergency (PHE) where the research involves human participants -requires robust regulation against the backdrop of historical injustices and irresponsible practices, and what is often a well-intentioned 'rush' for solutions in public health interventions [9][10][11][12]. For these reasons, international ethical principles and guidelines are continuously developed, revised, and promoted to ensure that public health research is ethically sound, scientifically relevant, and robust and that human rights are upheld [5,7,10,[13][14][15].…”