A roadmap to integrate existing knowledge into pharmaceutical Environmental Risk Assessment

A new public report from the ETERNAL project provides an overview of the current EMA regulation covering the environmental risk assessment of pharmaceuticals, followed by a comparison against the new proposed Regulation and Directive published earlier in 2023. The report concludes with a series of recommendations for integrating the latest scientific knowledge into pharmaceutical risk assessment to help fill gaps in the current and proposed legislation.

A key aspect of evaluating the environmental impact and sustainability of pharmaceuticals is assessing the risk that they may pose to ecosystems. The report’s authors from UKCEH, the United Kingdom’s Centre for Ecology and Hydrology, supported by CESAM at the University of Aveiro and AIMPLAS, therefore review current guidance from the the European Medicines Agency (EMA) on the environmental risk assessment of pharmaceuticals, and comment on the potential for significant change as part of the intended overhaul of broader pharmaceutical legislation under the European Commission’s (EC) Pharmaceutical Strategy for Europe. In the context of the new legislation requiring broader life cycle assessment (LCA), they also review the current status of pharmaceutical life cycle assessment.

Whilst the new legislation offers enhanced protection in several areas, the report goes on to consider areas where it could be strengthened. identifies gaps and potential areas for improvement (for example consideration of the risks posed by chemical mixtures and improvements to testing for endocrine disruptions alongside other sub-lethal effects) and lay out steps that could be taken to address these. These recommendations cover the full range of assessing environmental risk, from advancing our assessment of environmental exposure, to ensuring effects testing is broad enough to consider sub-lethal effects that might have significant long-term impacts on ecosystems.

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