Leveraging stringency and lifecycle thinking to advance environmental sustainability in health technology regulation.

Abstract

Regulatory actors, particularly market authorization agencies, health technology assessment agencies, and health care procurement agencies, exert a powerful influence on the adoption and use of health technologies (eg, medicines and medical devices). With health care being responsible, directly and indirectly, for an estimated 4.6% of global greenhouse gas emissions, alongside other environmental harms, these actors have recognized the need to address the environmental impacts of health technologies. In this commentary, we utilize concepts of regulatory stringency and lifecycle thinking, considering scope, prescriptiveness, and performance requirements, to analyze recent efforts to incorporate environmental sustainability into the regulation of medicines and medical devices. While we acknowledge recent progress, we argue that there is significant, untapped potential for developing more fulsome and effective regulatory mechanisms to improve the environmental sustainability of health technologies.