On the implementation of the Urban Wastewater Treatment Directive (UWWTD) and risks to the security of supply of medicines

European Parliament resolution on the implementation of the Urban Wastewater Treatment Directive (UWWTD) and risks to the security of supply of medicines

(2026/2652(RSP))

– having regard to the Treaty on the Functioning of the European Union (TFEU), and in particular Articles 168 and 191 thereof,

– having regard to Article 35 of the Charter of Fundamental Rights of the European Union,

– having regard to Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment (revised UWWTD), which entered into force on 1 January 2025,

– having regard to Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (Water Framework Directive),

– having regard to Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration and Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy , amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council,

– having regard to Decision (EU) 2022/591 of the European Parliament and of the Council of 6 April 2022 on a General Union Environment Action Programme to 2030,

– having regard to its resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem,

– having regard to the Commission staff working document of 26 October 2022 entitled ‘Impact Assessment, accompanying the Proposal for a Directive of the European Parliament and of the Council concerning urban wastewater treatment’ (SWD(2022)0541),

– having regard to the Commission communication of 12 May 2021 entitled ‘Pathway to a Healthy Planet for All – EU Action Plan: “Towards Zero Pollution for Air, Water and Soil”’ (COM(2021)0400),

– having regard to the report of the Joint Research Centre (JRC) of 10 December 2025 entitled ‘Updated estimation of the costs of quaternary wastewater treatment in the EU – A comparison of cost models’,

– having regard to the ongoing work on the Critical Medicines Act,

– having regard to Rules 142(5) and 136(4) of its Rules of Procedure,

A. whereas Article 191 TFEU lays down that EU policy on the environment ‘shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union’, and that it ‘shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay’;

B. whereas water is essential for life and humanity; whereas the EU must manage current and future water resources efficiently and respond effectively to the current water challenges, as they directly affect human health, the environment and its ecosystems, and strategic socio-economic activities;

C. whereas micropollutants, which are found in all kinds of water bodies and are detected in all EU waters, have damaging effects on human health, including carcinogenic and endocrine-disrupting effects, and on aquatic life, even in low concentrations, and contribute to the spread of antimicrobial resistance (AMR); whereas the World Health Organization declared AMR as an urgent global health crisis that is projected to cause more deaths globally than cancer by 2050; whereas many micropollutants from medicinal products end up in the water after patient use rather than during production or disposal;

D. whereas water pollution, including from micropollutants, poses a growing and severe threat to ecosystems, biodiversity and human and animal health and currently costs the EU over EUR 75 billion annually; whereas urban wastewater is one of the main sources of water pollution, if not properly collected and treated; whereas removal of micropollutants from contaminated wastewater is required to avoid its hazardous effects on health and the environment;

E. whereas many municipalities and communities in the EU rely on bank filtration for their drinking water, resulting in water supplies that are increasingly contaminated with micropollutants;

F. whereas costs for primary, secondary and tertiary treatment are generally covered by public bodies through taxpayer money or water charges; whereas the application to water treatment of the ‘polluter pays’ principle enshrined in Article 191 TFEU was first introduced in the revised UWWTD;

G. whereas the UWWTD sets the legal framework for the collection, treatment and discharge of urban wastewater and the discharge of biodegradable wastewater from certain industrial sectors, whereas the revised UWWTD aims to reduce water pollution, including micropollutants, and protect water quality across the EU; whereas micropollutants in wastewater are not effectively removed by conventional wastewater treatment; whereas the revised directive introduces the obligation of quaternary treatment of wastewater, which removes micropollutants, thereby ensuring a high level of protection of health and the environment, in line with the One Health approach; whereas the revised directive requires the systematic upgrade to quaternary treatment of large treatment plants serving over 150 000 people (i.e. in large cities, as these are hotspots for the release of micropollutants) and requires smaller treatment plants to upgrade only if they are in risk areas;

H. whereas the implementation of quaternary treatment is gradual, starting in December 2033, at which point only 20 % of the larger plants and 10 % of the smaller plants will need to be upgraded, with full implementation to be achieved by December 2045; whereas the introduction of quaternary treatment as an additional and advanced treatment of urban wastewater in order to eliminate the broadest possible spectrum of micropollutants is needed to reduce these pollutants and protect public health and the environment; whereas the introduction of quaternary treatment represents the most costly component of the directive;

I. whereas the polluter pays principle is a legally binding principle enshrined in Article 191 TFEU, and aims to ensure that those responsible for causing environmental damage, and not taxpayers or the wider society, should pay for the costs of preventing, controlling and remedying that pollution;

J. whereas Extended Producer Responsibility (EPR) aims at internalising environmental externalities and provides an incentive for producers to take into account environmental considerations along the life cycle of products, from design phase to end-of-life, effectively implementing the polluter pays principle; whereas most existing EPR schemes have been developed in the context of waste streams from identifiable point sources, where producers can effectively organise, monitor and control collection and treatment systems;

K. whereas medicinal products are developed and authorised with the objective of treating patients; whereas environmental risk assessments are a necessary criterion for the authorisation of medicinal products but the environmental risk does not form part of the benefit-risk evaluation in the authorisation of medicinal products;

L. whereas data and analyses by the Commission and the JRC show that pharmaceuticals and cosmetics are the source of the highest share of potentially harmful and hard-to-biodegrade substances found in wastewater; whereas certain market authorisation holders report that the toxic loads attributed to certain products in these analyses differ from data from the environmental risk assessments of medicinal products;

M. whereas the revised UWWTD introduced EPR provisions in line with the polluter pays principle, which require that at least 80 % of the costs of quaternary treatment be covered by the main sectors identified as responsible for the release of the pollutants, namely the pharmaceutical and cosmetics industries;

N. whereas EPR aims to finance the removal of micropollutants from wastewater and encourage the development of less toxic, more biodegradable products which are exempted from EPR; whereas the EPR system incentivises and rewards innovation in the development and use of less harmful substances in the sectors concerned;

O. whereas access to safe, effective and affordable medicines is a cornerstone of EU public health systems, and the security of supply of medicines in the EU must be safeguarded;

P. whereas according to the Commission’s impact assessment and independent data, the potential increase in costs of products or the potential reduction of the profit margins of the industries placing products on the EU market resulting from the application of EPR would be marginal, and would not endanger the affordability, availability or accessibility of those products on the EU market;

Q. whereas cost estimates by some Member State authorities exceed those provided in the Commission’s impact assessment (e.g. Germany and Spain have reported costs that are several times higher); whereas the Commission’s impact assessment has also been contested by certain stakeholders, notably as regards the environmental contribution of pharmaceuticals and cosmetics and the calculations of the effects on medicine prices; whereas the JRC carried out a second study with the aim of clarifying and further investigating the potential costs to be covered by industrial sectors affected by the directive; whereas this new study largely confirmed the previous data and findings;

R. whereas generic medicines account for nearly 70 % of medicines dispensed in the EU and are essential for healthcare system sustainability; whereas manufacturers of generic medicines typically operate under strict pricing frameworks and on a high-volume, low-margin economic model, limiting their ability to absorb additional regulatory costs. and may therefore be more sensitive to increases in costs, requiring careful monitoring of the implementation of the directive;

S. whereas generic medicines are based on the same active ingredient as the reference medicinal product, which increases the challenge for generics manufacturers of addressing the pollution at source;

T. whereas medicine shortages in the EU have worsened in recent years and pose risks to patient care; whereas the EU remains highly dependent on non-EU countries for active pharmaceutical ingredients; whereas the EU is taking steps to address medicine shortages and security of supply, including through the revised general pharmaceutical legislation and the Critical Medicines Act;

U. whereas the revised UWWTD allows Member States flexibility in the design of EPR schemes and in establishing methodologies for calculating contributions, enabling them to design EPR schemes in ways that ensure proportionality and avoid unintended consequences, including risks to the supply of medicines, thereby balancing public health objectives with environmental responsibilities;

V. whereas Article 10 of the revised UWWTD makes monitoring and enforcement frameworks mandatory, including ensuring that the impacts of the directive, including on medicine prices, are duly monitored;

W. whereas recital 20 of the revised UWWTD confirms that the directive already provides for regular evaluation based on monitoring data and scientific evidence, including the possibility of updating the scope of the system where necessary, thereby providing sufficient flexibility within the existing legal framework without the need to revisit the directive;

X. whereas the revised UWWTD requires the Commission to carry out a comprehensive evaluation by the end of 2033 and again by the end of 2040, providing the opportunity to consider the impacts of the directive and, if necessary, to propose adjustments;

Y. whereas the Commission estimates that, even in a scenario of full cost pass-through, the impact on medicine prices would amount to EUR 2.64 to EUR 3.20 per person per year by 2045; an estimate that was reconfirmed in December 2025 by the JRC, which took into account the final text adopted by the co-legislators;

Z. whereas the directive provides for a long implementation timeline, with certain provisions not applying fully until 2045, allowing sufficient time for the gradual and balanced implementation of the directive and its quaternary treatment obligations, namely 20 % coverage by 2033, 60 % by 2039, and full coverage by 2045; whereas the directive provides Member States with time to adjust the pricing of contracts through new tendering procedures for medicines;

AA. whereas even under a scenario of full cost pass-through, according to the Commission’s impact assessment and the JRC study, the resulting increase in the price of medicines remains marginal when compared to the cost of non-action, as the substantial long-term healthcare expenditures associated with diseases linked to micropollutant exposure, notably including cancer, already impose a markedly greater burden on public health systems and this is expected to rise significantly;

AB. whereas the costs related to the contributions to the quaternary treatments are based on products placed on the market, and therefore include all products, whether produced in or outside the EU, and the EPR obligation applies uniformly to all companies placing products on the EU market, ensuring a level playing field and preventing unfair competitive advantages; whereas the directive aims, therefore, not to produce distortionary effects on the market or generate disadvantages for EU producers and the overall competitiveness of the sector; whereas it is very important to ensure that all imported products comply with and finance EPR obligations, including all private small shipments, such as online orders;

AC. whereas the Commission’s impact assessment shows that, in the absence of EPR, the estimated annual costs of quaternary treatment of approximately EUR 1.186 billion per year by 2040 would otherwise have to be covered primarily through higher water tariffs and from public budgets, thereby shifting pollution costs from industry to citizens and taxpayers, and placing an unfair burden on households, including the most vulnerable ones;

AD. whereas the implementation of the EPR scheme is necessary to ensure legal and financial certainty, notably for public bodies, and to ensure the necessary investment in wastewater infrastructure to meet environmental and public health objectives and to ensure that citizens and water consumers do not bear the financial cost of pollution for which they are not responsible;

AE. whereas the new environmental quality standards, in particular the nine pharmaceutical environmental quality standards under the Water Framework Directive, cannot be achieved without advanced and additional water treatment;

AF. whereas the revised UWWTD obliges the Commission, on the basis of the results of the urban wastewater monitoring and the most recent scientific data, to regularly evaluate whether other products should be included in the EPR system; whereas the Commission should present the first formal review by 2033 at the latest;

1. Reaffirms its strong support for the environmental objectives and the implementation of the revised UWWTD in accordance with the deadlines set, and underlines the need to reduce and address water pollution, including micropollutants;

2. Underlines the need to better protect human health and the environment as part of an ambitious approach to tackling pollution from all sources and to move towards a toxic-free environment, notably including the need to tackle hazardous micropollutants, which pose a substantial and acute threat to health and the environment;

3. Recalls that environmental policy should be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should, as a priority, be rectified at source and that the polluter should pay;

4. Stresses that the introduction of quaternary treatment is necessary to protect health, safeguard ecosystems and combat emerging risks such as AMR; underlines, in this regard, that EPR is the most effective tool for implementing the polluter pays principle as set out in Article 191(2) TFEU and for ensuring sufficient funds for the necessary treatment of urban wastewater;

5. Takes notes of the divergence between the cost estimates of the Commission’s impact assessment and the cost estimates produced in public assessments following the adoption of the directive, notably in Germany and Spain; notes, furthermore, the concerns of stakeholders about the robustness of the methodology used to attribute toxic loads and notes the concerns about the differences between the data used by the Commission and the environmental risk assessment data submitted to the European Medicines Agency in the market authorisation procedure; considers that these concerns should be thoroughly addressed to ensure the robustness of the facts underpinning the cost analyses of the quaternary treatment and the EPR scheme; notes, however, that the different methodologies applied to the studies may explain some of the divergences, and stresses that the estimates of the impact assessment were recently reconfirmed by the JRC;

6. Calls on the Commission to produce a new independent study by the end of 2026 identifying the list of substances present in urban wastewater, verifying the costs of quaternary treatment and the attribution of responsibility to the relevant sectors under the polluter pays principle, and identifying the potential impact on the availability, affordability and accessibility of medicines, in particular generic and critical medicines and their active substances; considers that the Member States, through the Human Pharmaceutical Committee, and the European Environment Agency and the European Medicines Agency should be appropriately involved in the study, within their areas of competence; calls on the Commission to accelerate, if necessary on the basis of the study results, the evaluation of the allocation of substances, and also, if necessary, to immediately reattribute EPR obligations to the sectors identified as responsible; considers that, if the results of the study demonstrate significant risk to the affordability, availability and accessibility of medicines, in particular critical and generic medicines, the Commission should swiftly adopt safeguards to guarantee the security of supply of these medicines;

7. Stresses that the costs associated with advanced wastewater treatment should not be shifted onto taxpayers and water consumers, but should be borne in a fair and proportionate manner by those sectors contributing to water pollution;

8. Recalls the gradual implementation timeline for the EPR and quaternary treatment obligations, with certain provisions not fully applying until 2045, which provides sufficient time for the gradual and balanced implementation of the directive and the quaternary treatment obligations, namely 20 % coverage by 2033, 60 % by 2039 and full coverage by 2045; recalls that the technical aspects of the EPR provisions and national EPR organisations can be adjusted at both EU and national level to ensure fairness and effectiveness; calls for both the Commission and the Member States to make full use of the directive’s existing provisions to ensure that evidence and appropriate and reliable data are fully taken into consideration in the implementation of the directive;

9. Underlines that the EPR obligation applies uniformly to all companies placing products on the EU market, whether produced in or outside the EU, aiming to ensure a level playing field and preventing unfair competitive advantages; calls on the Commission to clarify how non-EU producers will comply with EPR obligations, in order to avoid competitive distortions and to ensure a level playing field;

10. Stresses that medicine shortages are already a major and growing challenge in the EU; highlights the need to safeguard EU pharmaceutical manufacturing capacity and supply chain resilience;

11. Acknowledges the particular case of generic medicines and access to treatments in general and calls on the Commission and the Member States to carefully and continually monitor the impact of the directive on the affordability, availability and accessibility of those medicines, as is required under the revised UWWTD, with the objective of avoiding unintended disruption or price increases;

12. Recalls that the directive provides for flexibility and the possibility of applying proportionate measures with the aim of ensuring that the EPR obligations do not compromise the affordability, availability or accessibility of medicines; calls on the Member States, when designing and implementing national EPR schemes, to carefully assess and address duly justified and evidence-backed concerns related to unintended consequences of the directive, with particular attention to generic medicines; recalls the obligation of the Commission to monitor and report on impacts on medicine affordability, availability and accessibility and to ensure a comprehensive evaluation by the end of 2033 and again by the end of 2040;

13. Recalls that EPR represents the most effective and fair financing model for quaternary treatment, ensuring stable investment, while avoiding additional pressure on public budgets and water tariffs, and providing an incentive for the development of products that biodegrade rapidly or that do not generate micropollutants in wastewater at the end of their life cycle; notes, however, the challenges of availing of the incentive, owing to the complexities of modifications to medicinal formulations, which may require extensive research or new marketing authorisations, in particular for generic medicines;

14. Recalls, in this regard, that the Commission is required to regularly evaluate whether other products and sectors that have a significant impact on the toxic load in wastewater should be brought into the EPR system, so as to ensure that the associated costs are fairly attributed and not left to fall on citizens and water consumers;

15. Supports research and innovation in environmentally sustainable pharmaceuticals and in advanced wastewater treatment technologies;

16. Recalls that, in line with the One Health approach, the protection of human, animal and environmental health are intrinsically interlinked and intwined; underlines that access to medicines and environmental protection must be pursued simultaneously, without allowing one to be used as a pretext for lowering ambition in the other;

17. Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.