Environmental impact assessment and control of pharmaceuticals: the role of environmental agencies

In 2005, the new legislation for pharmaceuticals came into effect. Since then environmental risk assessments are required for all new marketing authorisation applications. The German Federal Environment Agency has been assessing the environmental impact of 136 veterinary and 134 human pharmaceuticals. The authorisation of pharmaceuticals has shown that the authorisation of some groups of substances have to be combined with risk mitigation measures. Environmental risks may also arise from those pharmaceuticals which were authorised before the environmental risk assessment was added to the requirements of authorisation. Four examples of “existing” pharmaceuticals, i.e. diclofenac, ethinyl estradiol, ivermectin, and florfenicol are highlighted in this article. Risk management options for veterinary and human pharmaceuticals are discussed.