LOST IN DEFINITION: THE LEGAL STATUS OF PHARMACEUTICAL WASTE IN EU LAW
2026, 111, No. 1
University of Silesia in Katowice, Doctoral School
Publication date
Publishing model
License type
Field
Discipline
Language of publication
Downloads
PDF 407 KB
Number of views:2
Number of downloads:2
Crossref citations:0
Altmetric score:0
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.
Keywords:
Bibliography
Bradley CP and Bond ChM, ‘Increasing the number of drugs available over the counter: arguments for and against’ 1995) 45(399) British Journal of General Practice 553–556
Caban M and Stepnowski P, ‘How to Decrease Pharmaceuticals in the Environment? A Review’ (2021) 19 Environmental Chemistry Letters 3115
Castensson S, ‘Pharmaceutical Waste’ in K Kümmerer (ed), Pharmaceuticals in the Environment: Sources, Fate, Effects and Risks (Springer Science & Business Media 2008) 489
Cheyne I, ‘The Definition of Waste in EC Law’ (2002) 14(1) Journal of Environmental Law 63
Chung S and Brooks BW, ‘Identifying Household Pharmaceutical Waste Characteristics and Population Behaviors in One of the Most Densely Populated Global Cities’ (2019) 140 Resources, Conservation & Recycling 267
Commission Notice ‘Separate Collection of Household Hazardous Waste’ [2020] OJ C375/1
Communication from the Commission, ‘European Union Strategic Approach to Pharmaceuticals in the Environment’ COM (2019) 128 final Cristini I and others, ‘A narrative review on the environmental impact of medicines: from water analysis and in vivo studies to prescribing appropriateness, based on European and Italian legal frameworks’ (2025) 5 Frontiers in Drug Safety and Regulation 1681648
Daughton CG, ‘Cradle-to-Cradle Stewardship of Drugs for Minimizing Their Environmental Disposition While Promoting Human Health. I. Rationale for and Avenues toward a Green Pharmacy’ (2003) 111(5) Environmental Health Perspectives 757
EEA, ‘Pharmaceuticals in the Environment: Results of an EEA Workshop’ (EEA 2010) 10European Commission Health and Food Safety Directorate-General, ‘Pharmaceuticals in the Environment: Implement the EU Strategic Approach – Compilation of Recommendations and Best Practices’ (2025)
EMA, ‘Environmental Risk Assessment of medicines’ (EMA 2015)
EMA, What we do <https://www.ema.europa.eu/en/about-us/what-we-do#monitor-the-safety-of-medicines-across-their-lifecycle-12356> accessed 20 November 2025
Haberko J (ed), System Prawa Medycznego. Tom 4: Prawo farmaceutyczne (CH Beck; Institute of Legal Sciences, Polish Academy of Sciences 2019) 345
Haithem A, Parvez MS, Czedli HM, ‘Pharmaceuticals and Microplastics in Aquatic Environments: A Comprehensive Review of Pathways and Distribution, Toxicological and Ecological Effects’ (2025) 22(5) International Journal of Environmental Research and Public Health 799
Hernández Ramos M and Heydt V, ‘Legislative Language and Style’ in U Karpen, H Xanthaki (eds), Legislation in Europe: A Comprehensive Guide for Scholars and Practitioners (Hart Publishing 2017) 134
ICRC, ‘Medical Waste Management’ (ICRC 2011)
Jaseem M, Kumar P and John RM, ‘An Overview of Waste Management in Pharmaceutical Industry’ (2017) 6(3) The Pharma Innovation Journal 158
Jovanović V and others, ‘Management of Pharmaceutical Waste in Hospitals in Serbia – Challenges and the Potential for Improvement’ (2016) 50(4) Indian Journal of Pharmaceutical Education and Research 700
Kadam A and others, ‘Pharmaceutical Waste Management: An Overview’ (2016) 9(1) Indian Journal of Pharmacy Practice 2
Krekora M, Świerczyński M and Traple E, Prawo farmaceutyczne (Wolters Kluwer Polska 2020) 31
Kocot J, Prawo Unii Europejskiej wobec procederu fałszowania produktów leczniczych (Instytut Wydawniczy EuroPrawo 2018) 40
Kornfeld L and Prouty A, ‘The War on Drugs: Pharmaceutical Waste Management Challenges and Emerging Issues’ (2014) 28 Natural Resources & Environment 27
Korzycka M, Zboralska M and Wojciechowski P, ‘Suplementy diety i żywność specjalnego przeznaczenia medycznego’ in J Haberko (ed), System Prawa Medycznego. Tom 4: Prawo farmaceutyczne (CH Beck; Institute of Legal Sciences, Polish Academy of Sciences 2019)
Kümmerer K (ed), Pharmaceuticals in the Environment: Sources, Fate, Effects and Risks (Springer Science & Business Media 2008)
Medical Device Coordination Group, ‘Manual on Borderline and Classification for Medical Devices under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices’ Version 2 (2022) 37
OECD, Management of Pharmaceutical Household Waste: Limiting Environmental Impacts of Unused and Expired Medicine (OECD Publishing 2022)
Pines E and Smith Ch, ‘A 10-Step Blueprint for Managing Pharmaceutical Waste in US Healthcare Facilities’ 2022 Edition (US EPA 2022)
Résomédit, C2DS, ‘Médicaments à l’hôpital : [ré]agir pour moins jeter’ 2026.
Rogowska J and others, ‘Pharmaceutical Household Waste Practices: Preliminary Findings from a Case Study in Poland’ (2019) 64 Environmental Management 97
Sarla GS, ‘Efficacy and disposal of drugs after the expiry date’ (2019) 31(4) The Egyptian Journal of Internal Medicine 431
Stoś K, ‘Suplementy diety czy leki?’ Narodowe Centrum Edukacji Żywieniowej <https://ncez.pzh.gov.pl/abc-zywienia/suplementy-diety-czy-leki/> accessed 20 November 2025
UNEP, An Assessment Report on Issues of Concern: Chemicals and Waste Issues Posing Risks to Human Health and the Environment (UNEP 2020)
UNEP, Safe disposal of unused medicines – A One Health approach for national systems (UNEP 2026)
Van Calster G and Reins L, EU Environmental Law (Edward Elgar Publishing 2017) 267
Vogler S and others, ‘Medicines Discarded in Household Garbage: Analysis of a Pharmaceutical Waste Sample in Vienna’ (2014) 7 Journal of Pharmaceutical Policy and Practice 6
WHO, ‘Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies’ (WHO 1999)
WHO, ‘Safe Management of Wastes from Healthcare Activities’ (WHO 1999)
WHO, ‘Safe Management of Wastes from Healthcare Activities 2nd edition’ (WHO 2014)
WHO ‘Global analysis of healthcare waste in the context of COVID-19: status, impacts and recommendations’ (WHO 2022) 6
WHO, Health-care Waste: Fact Sheet <https://www.who.int/en/news-room/fact-sheets/detail/health-care-waste> accessed 16 November 2025
WHO, ‘Safe management of pharmaceutical waste from health care facilities: global best practices’ (WHO 2025)
Other articles from the issue
11.08.2026
real rightsdivided propertyDuchy of WarsawCongress PolandDIVIDED OWNERSHIP IN LEGISLATION AND LEGAL PRACTICE OF THE DUCHY OF WARSAW AND THE CONGRESS POLAND
Piotr Z Pomianowski
12.08.2026
genocideSrebrenicamemory lawreconciliationdenialAT THE CROSSROADS OF PEACE AND DENIAL: SREBRENICA THIRTY YEARS LATER
Małgorzata Myl-Chojnacka
12.08.2026
Alternative Dispute Resolutionnegotiationmediationreleasenegotiated settlementmediated settlementenforcement of negotiated settlementenforcement of mediated settlementapproval of negotiated settlementapproval of mediation settlementsettlementamicable settlementcourt settlementENFORCEMENT OF NEGOTIATED AND MEDIATED SETTLEMENTS IN THE EU AND IN THE ANGLOSPHERE: A COMPARATIVE APPROACH
Piotr Sławicki, Stephen Ware
Similar publications
30.04.2026
rights of naturelegal subjectivityenvironmental protection lawEU lawaccess to justiceSTANDING WITHOUT LEGAL PERSONALITY: THE PROCEDURAL DIMENSION OF RIGHTS OF NATURE IN THE EUROPEAN UNION
Wiktoria Woźny
03.02.2024
gender-based violencelegal instrumentspreventionEU lawPREVENTING AND COMBATTING GENDER-BASED VIOLENCE IN CZECHIA – A SUCCESS STORY?
Kristina Koldinská
02.05.2022
transparency principlepublic procurement lawEU lawzasada przejrzystościprawo zamówień publicznychprawo UEApplication of the principle of transparency in public procurement law by the Court of Justice of the European Union
Joanna Florecka