Environmental risk assessment of pharmaceuticals: A proposal with special emphasis on European aspects

From an ecotoxicological point of view, pharmaceuticals were not considered to be a problem until the early 1990s (1). The need for data on the fate and effects of veterinary pharmaceuticals in the environment was identified for the first time in The Netherlands (2). Since then the environmental risk caused by pharmaceuticals, in general, was re-evaluated (3), mainly because an ever increasing number of drugs were detected in the environment (4). Therefore governmental authorities began to discuss how medicinal products should be dealt with from an ecotoxicological point of view. Today, prudence and good practice dictate that an environmental risk assessment (ERA) for new pharmaceuticals should be performed. Current practice follows the same rules that have been established for other chemicals (nothing is required for existing drugs). However, there are some large discrepancies in how such an ERA should look in detail. In this paper a short overview on the legal status in the European Union (EU) concerning environmental aspects of the registration procedure for new medicinal products is given. In addition, a modified ERA for (human) medicinal products is proposed and compared with ERA procedures currently used in the EU. Since the situation in the USA is described by Velagaleti and Gill (this volume) it will not be discussed in any detail here.