Environmental considerations in the European Union's pharmaceuticals legislation: Key instruments and their challenges in addressing global manufacturing supply chains

Abstract

AbstractThis article analyses how two key instruments of European Union pharmaceuticals legislation—good manufacturing practices and environmental risk assessment of pharmaceuticals—address known risks posed by the release of pharmaceuticals in the environment to human health and the environment and identifies the challenges that they face in regulating global manufacturing supply chains. The analysis reveals that these instruments fail to address the environmental challenges posed by pharmaceuticals within global manufacturing supply chains. Based on these findings, we propose to revise European pharmaceuticals legislation by expanding the scope and information requirements of both human and veterinary environmental risk assessment and increasing its weight in the risk–benefit analysis for human pharmaceuticals; by including direct environmental requirements for certain prioritized pharmaceuticals; and by integrating environmental considerations and related verification mechanisms into good manufacturing practices.