Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare

Provisionally accepted

To mitigate healthcare’s unintended effects, environmental risk data such as ecotoxicity and environmental contamination need to be considered by all stakeholders in the healthcare value chain. As decision-makers and educators, health care providers are in a unique position to make healthcare delivery more sustainable. However, current benefit-risk assessments of therapeutic products do not systematically include environmental risk data. The purpose of this paper was to review the literature and regulatory context and propose expanding benefit-risk assessments of therapeutic products to include an evidence-based evaluation of environmental impact to inform decision-making. Our findings indicate that environmental risk assessments need to be broadened to include aspects such as excipients, synergistic effects of contaminants, and risks to humans (e.g., drinking water). Concrete proposals to improve current regulatory guidelines for environmental risk assessment already exist. Open access databases on environmental risk of substances used in products for human consumption are available. The European Union Regulation on Medical Devices provides the basis for evidence-based approach to developing sustainable therapeutic products based on natural substances. Based on this, the here promoted decision scheme for healthcare providers (and other stakeholders) involves comparing the clinical safety and efficacy of therapeutic products; comparing environmental impact data; and then deciding. A case example involving the treatment of patients with gastroesophageal reflux and dyspepsia is presented. We provide suggestions for integrating persistence and ecotoxicity data into clinical practice. Expanding the benefit-risk assessment to include data on environmental impact during clinical decision-making is a way to achieve a healthier outcome for all.