LOST IN DEFINITION: THE LEGAL STATUS OF PHARMACEUTICAL WASTE IN EU LAW
TL;DR
It is argued that current EU law lacks a coherent concept of pharmaceutical waste capable of addressing the increasing environmental risks associated with active pharmaceutical ingredients (APIs), and a proposal for a definition of pharmaceutical waste is proposed.
Abstract
The article demonstrates the increasing environmental risks associated with active pharmaceutical ingredients (APIs) and argues that current EU law lacks a coherent concept of pharmaceutical waste capable of addressing these risks. Existing practice often equates pharmaceutical waste with unused or expired medicinal products or subsumes it under medical waste, a broad category that fails to capture the diverse sources, decentralised generation, and specific chemical characteristics of APIs. As a result, legal obligations concerning waste collection, classification, and liability remain unclear. A distinct legal category of pharmaceutical waste is necessary to enable targeted regulatory measures and improve environmental and health protection. The article analyses the legal status of pharmaceutical waste in EU legislation, soft law, and academic literature, and explores its relationship to medical waste. It then develops two approaches to defining pharmaceutical waste: one based on enlisting source products and another based on the properties of source products (presence of APIs or API-like substances). The first approach mirrors current usage but poses the risk of excluding environmentally relevant products and importing long-standing classification ambiguities. A composition-based approach better reflects scientific insights from the pharmaceuticals in the environment (PiE) field, capturing contaminated materials and immediate packaging where appropriate. The paper concludes with a proposal for a definition of pharmaceutical waste.