Expert perspectives on potential environmental risks from nanomedicines and adequacy of the current guideline on environmental risk assessment

Abstract

In the next couple of decades, nanotechnology-enabled healthcare applications will significantly influence the diagnosis, prevention and treatment of human diseases. Since pharmaceutical products (PPs) have been detected in various environmental compartments, and low-level chronic exposure to PPs has induced adverse and sometimes unexpected effects on non-target organisms, the question of potential environmental risks from increased usage of nanomedical products arises. The risks and benefits to patients from nanomedicines are the focus of exhaustive evaluation by regulatory agencies; by contrast, risks to the environment from nanomedicines are only briefly considered by regulators and are rarely discussed by nanoscientists. To start to fill this gap, 66 experts from nanomedicine R&D, representatives of research funding agencies and of institutions involved in safeguarding public health and the environment were interviewed using a semi-structured questionnaire regarding possible hazards and risks from nanomedicine and on the adequacy of current the environmental risk assessment (ERA) framework for medicines. The interview recordings were transcribed verbatim and analysed via qualitative content analysis. Experts interviewed commented that hazards were possible but risks were unlikely from nanomedicines due to expected minimal exposure. They qualified their statements by comparing risks from nanomedicine with risks from nanomaterials in other industries, conventional pollutants and larger global issues like climate change. Regarding adequacy of the current risk framework for assessment of environmental risks from nanomedicines, perceptions of experts were more varied; some argued that complete overhaul of the ERA framework was required including changes in toxicity endpoints, whereas others suggested that the framework was adequate, though some adjustments were needed.