Continuous improvement towards environmental protection for pharmaceuticals: advancing a strategy for Europe
Abstract The manufacture, use and disposal of pharmaceutical products can lead to their release into the environment, raising concerns about potential risks to biota and human health. This is recognised in the European Commission’s Pharmaceutical Strategy for Europe, which has recently overseen the...
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| Format: | Article |
| Language: | English |
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SpringerOpen
2025-07-01
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| Series: | Environmental Sciences Europe |
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| Online Access: | https://doi.org/10.1186/s12302-025-01180-z |
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| author | Sam Harrison Catherine Barnett Stephen Short Cansu Uluseker Patricia V. Silva Maria D. Pavlaki Sarah Roberts Madalena Vieira Stephen Lofts Susana Loureiro David J. Spurgeon |
| author_facet | Sam Harrison Catherine Barnett Stephen Short Cansu Uluseker Patricia V. Silva Maria D. Pavlaki Sarah Roberts Madalena Vieira Stephen Lofts Susana Loureiro David J. Spurgeon |
| author_sort | Sam Harrison |
| collection | DOAJ |
| description | Abstract The manufacture, use and disposal of pharmaceutical products can lead to their release into the environment, raising concerns about potential risks to biota and human health. This is recognised in the European Commission’s Pharmaceutical Strategy for Europe, which has recently overseen the development of a proposed revision of current pharmaceutical legislation. Amongst other things, this strategy and revision broadly offer strengthened protection against environmental risk. For example, it enhances the power authorities have to refuse market authorisation where an identified risk to the environment cannot be sufficiently addressed, includes a requirement for legacy pharmaceutical products to be risk assessed, includes a broadened scope to cover the entire product lifecycle, and places a greater focus on open data. In this publication, we assess the proposed legislation against the latest scientific knowledge, identifying opportunities for strengthening the protection that it offers. These opportunities include moving towards the risk assessment of mixtures, broadening the scope of effects testing to include non-conventional (e.g., behavioural) and chronic endpoints, making better use of predictive modelling such as Quantitative Structure–Activity Relationships (QSARs), and better accounting for environmental heterogeneity, such as the influence of temperature and especially pH on risk. Many of the elements discussed apply not just to pharmaceuticals but across other chemical domains and regulatory regimes, particularly when considering mixture assessment. Integrating knowledge across sectors and regulatory regimes is therefore crucial to better address the role of pharmaceuticals as one of many environmental pollutants. |
| format | Article |
| id | doaj-art-0822e07cbd9f44cfa714aad7aa2047bc |
| institution | DOAJ |
| issn | 2190-4715 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Environmental Sciences Europe |
| spelling | doaj-art-0822e07cbd9f44cfa714aad7aa2047bc2025-08-20T03:04:31ZengSpringerOpenEnvironmental Sciences Europe2190-47152025-07-0137112110.1186/s12302-025-01180-zContinuous improvement towards environmental protection for pharmaceuticals: advancing a strategy for EuropeSam Harrison0Catherine Barnett1Stephen Short2Cansu Uluseker3Patricia V. Silva4Maria D. Pavlaki5Sarah Roberts6Madalena Vieira7Stephen Lofts8Susana Loureiro9David J. Spurgeon10UK Centre for Ecology & HydrologyUK Centre for Ecology & HydrologyUK Centre for Ecology & HydrologyUK Centre for Ecology & HydrologyCESAM- Centre of Environmental and Marine Studies & Department of Biology, University of AveiroCESAM- Centre of Environmental and Marine Studies & Department of Biology, University of AveiroUK Centre for Ecology & HydrologyCESAM- Centre of Environmental and Marine Studies & Department of Biology, University of AveiroUK Centre for Ecology & HydrologyCESAM- Centre of Environmental and Marine Studies & Department of Biology, University of AveiroUK Centre for Ecology & HydrologyAbstract The manufacture, use and disposal of pharmaceutical products can lead to their release into the environment, raising concerns about potential risks to biota and human health. This is recognised in the European Commission’s Pharmaceutical Strategy for Europe, which has recently overseen the development of a proposed revision of current pharmaceutical legislation. Amongst other things, this strategy and revision broadly offer strengthened protection against environmental risk. For example, it enhances the power authorities have to refuse market authorisation where an identified risk to the environment cannot be sufficiently addressed, includes a requirement for legacy pharmaceutical products to be risk assessed, includes a broadened scope to cover the entire product lifecycle, and places a greater focus on open data. In this publication, we assess the proposed legislation against the latest scientific knowledge, identifying opportunities for strengthening the protection that it offers. These opportunities include moving towards the risk assessment of mixtures, broadening the scope of effects testing to include non-conventional (e.g., behavioural) and chronic endpoints, making better use of predictive modelling such as Quantitative Structure–Activity Relationships (QSARs), and better accounting for environmental heterogeneity, such as the influence of temperature and especially pH on risk. Many of the elements discussed apply not just to pharmaceuticals but across other chemical domains and regulatory regimes, particularly when considering mixture assessment. Integrating knowledge across sectors and regulatory regimes is therefore crucial to better address the role of pharmaceuticals as one of many environmental pollutants.https://doi.org/10.1186/s12302-025-01180-zPharmaceuticalsEnvironmental risk assessmentPharmaceutical legislationEcotoxicityEnvironmental exposure |
| spellingShingle | Sam Harrison Catherine Barnett Stephen Short Cansu Uluseker Patricia V. Silva Maria D. Pavlaki Sarah Roberts Madalena Vieira Stephen Lofts Susana Loureiro David J. Spurgeon Continuous improvement towards environmental protection for pharmaceuticals: advancing a strategy for Europe Environmental Sciences Europe Pharmaceuticals Environmental risk assessment Pharmaceutical legislation Ecotoxicity Environmental exposure |
| title | Continuous improvement towards environmental protection for pharmaceuticals: advancing a strategy for Europe |
| title_full | Continuous improvement towards environmental protection for pharmaceuticals: advancing a strategy for Europe |
| title_fullStr | Continuous improvement towards environmental protection for pharmaceuticals: advancing a strategy for Europe |
| title_full_unstemmed | Continuous improvement towards environmental protection for pharmaceuticals: advancing a strategy for Europe |
| title_short | Continuous improvement towards environmental protection for pharmaceuticals: advancing a strategy for Europe |
| title_sort | continuous improvement towards environmental protection for pharmaceuticals advancing a strategy for europe |
| topic | Pharmaceuticals Environmental risk assessment Pharmaceutical legislation Ecotoxicity Environmental exposure |
| url | https://doi.org/10.1186/s12302-025-01180-z |
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