What changed

B100282/2026

B100280/2026

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))

The European Parliament,

– having regard to Article 191 of the Treaty on the Functioning of the European Union,

–– having regard to Articles 3(3) TEU and Articles 9, 11, 168, 173, 191 and 192 TFEU,

– having regard to Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment (Urban Wastewater Treatment Directive),

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

– having regard to the Commission proposal of 11 March 2025 for a regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 (COM(2025)0102),

– having regard to Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment,

– having regard to the work of the Critical Medicines Alliance, in particular its recommendations on strengthening the resilience of supply chains for essential medicines,

– 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 the Commission communication of 29 January 2025 entitled ‘A Competitiveness Compass for the EU’ (COM(2025)0030),

– having regard to itsthe resolutionquestion to the Commission on the implementation of 7the MayUrban 2025Wastewater onTreatment Directive and risks to the Europeansecurity Waterof Resiliencesupply Strategy,of medicines (O-000013/2026 – B10-0008/2026),

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

– having regard to the Commission study of 10 December 2025 entitled ‘Updated estimation of the costs of quaternary wastewater treatment in the EU’,

– having regard to the Strategic Report of the Critical Medicines Alliance,

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

– having regard to the question for oral answer O-000013/2026,

– having regard to Rules 142(5) and 136(2) of its Rules of Procedure,

A. whereas Directivethe (EU)Urban 2024/3019Wastewater Treatment Directive (UWWTD) aims to reduceprotect waterhuman pollution,health includingand micropollutants,the andenvironment tofrom improvethe wateradverse qualityeffects throughoutof untreated urban wastewater, including through the EU;removal of micropollutants;

B. whereas theArticles Directive9 introducesand quaternary10 treatmentof requirementsthe andUWWTD introduce an Extendedextended Producerproducer Responsibilityresponsibility (EPR) scheme requiring the pharmaceutical and cosmetics sectors to cover at least 80 % of the costs of quaternary treatment for pharmaceuticalsthe removal of both micropollutants arising from products placed on the market and cosmetics;their residues;

C. whereas the introduction of quaternary treatment represents the most significant cost component of the Directive;

C. whereas, in accordance with the principle of proportionality, the allocation of costs under EPR schemes should be fair, proportionate and based on the respective contributions of different sectors to pollution, in order to avoid placing a disproportionate financial burden on certain industries;

D. whereas updated estimates from several Member States indicate substantially higher implementation costs than those anticipated in the Commission’s impact assessment;

D. whereas the application of the UWWTD requires that costs be allocated in proportion to the actual contribution to pollution, taking into account that micropollutants originate from multiple sources that often cannot be attributed exclusively to specific industrial sectors, including the use of products by consumers;

E. whereas local and regional authorities, municipalities and wastewater operators will bear major responsibilities for implementing the directive and face significant financing and investment challenges if no other contributions become available;

E. whereas cumulative regulatory and financial burdens, including those stemming from the UWWTD, risk undermining the EU’s competitiveness and attractiveness for cosmetics and pharmaceutical industries, as well as pharmaceutical innovation and investment, thereby affecting the development and timely availability of medicinal products;

F. whereas concerns have been raised regarding the methodology used to attribute micropollutant loads and to allocate costs among economic sectors;

F. whereas a disproportionate allocation of the costs of quaternary treatment to the pharmaceutical sector risks negatively affecting the availability and supply of medicinal products, potentially leading to market withdrawals, reduced competition and increased vulnerability of supply chains;

G. whereas many pharmaceutical residues enter wastewater systems through normal use by patients and cannot be addressed through conventional product redesign measures;

G. whereas Case T-158/25 before the General Court of the European Union, which concerned the allocation of costs under the EPR scheme introduced by the UWWTD, was dismissed by order on grounds of inadmissibility for lack of legal standing, thereby leaving unresolved substantive questions relating to proportionality and cost allocation;

H. whereas pharmaceutical manufacturers, particularly producers of generic medicines, operate under strict regulatory and pricing frameworks that limit their ability to absorb significant additional costs;

H. whereas Case C-193/25, currently pending before the Court of Justice of the European Union, raises questions on the interpretation of EU law concerning the application of the polluter-pays principle and the distribution of financial obligations under the UWWTD, the outcome of which may have implications for legal certainty and the uniform implementation of the framework across Member States;

I. whereas generic medicines account for the majority of medicines dispensed within the EU and are essential for affordable healthcare systems;

I. whereas taxpayers and water users should not bear the financial burden of quaternary treatment, and such costs must be allocated in a fair, proportionate and non-discriminatory manner;

J. whereas medicine shortages continue to affect patients across the EU and have become a major public health concern;

1. Expresses concerns regarding the current EPR system, which places a disproportionate financial burden on certain sectors, particularly the pharmaceutical and cosmetics industries; warns that this system risks undermining the supply, availability and affordability of medicinal and cosmetics products;

K. whereas the EU remains dependent on non-EU countries for significant parts of the pharmaceutical supply chain;

2. Underlines that available industry data suggests that the additional costs for the cosmetic and pharmaceutical sectors may have been significantly underestimated;

L. whereas both the pharmaceutical sector and the cosmetics sector provide high-quality employment, investment and innovation throughout the EU and form part of Europe’s strategic industrial base;

3. Stresses the importance of respecting the principle of subsidiarity by ensuring that Member States retain sufficient flexibility to determine and implement the most efficient and sustainable wastewater management solutions;

M. whereas additional regulatory burdens may contribute to production relocations, reduced investment and job losses within the EU;

4. Calls on the Commission to carry out a new comprehensive and independent impact assessment that reflects the principles of proportionality and of non-discrimination, including a more accurate estimation of sectoral contributions to micropollutants;

N. whereas the EU is currently moving forward with the Critical Medicines Act with the objective of strengthening pharmaceutical resilience, strategic autonomy and security of supply;

5. Calls on the Commission to ensure that the implementation of the UWWTD does not undermine the availability, affordability and supply security of medicinal products within the EU, as well as the development and timely availability of medicinal products;

O. whereas it is essential to ensure coherence between environmental legislation and the EU’s health, industrial and competitiveness objectives;

6. Calls, therefore, on the Commission to suspend the application of Articles 9 and 10 of the UWWTD (‘stop the clock’), and to present, following a comprehensive impact assessment and taking into account the need for a balanced approach, a proposal to amend this directive as regards those provisions;

P. whereas access to safe, effective and affordable medicines remains a cornerstone of European public health systems;

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

1. Reaffirms its strong support for the environmental objectives of Directive (EU) 2024/3019 and for efforts to reduce water pollution and micropollutants across the EU;

2. Stresses that environmental legislation should be implemented in a manner that safeguards public health, access to medicines, industrial competitiveness and social cohesion;

3. Underlines the importance of municipalities, wastewater operators, the pharmaceuticals sector and the cosmetics industry for the successful achievement of the directive’s objectives;

4. Expresses concern that updated implementation cost estimates for quaternary treatment significantly exceed original projections;

5. Notes that municipalities and wastewater operators may face considerable financial and administrative burdens in implementing the directive;

6. Calls for a comprehensive assessment of the overall financing framework for implementation, including the impact on local authorities, public budgets and consumers;

7. Questions whether the current methodology for pollution attribution and cost allocation sufficiently reflects all relevant sources of micropollutants;

8. Notes that existing assessments do not adequately address the potential effects on medicine availability, employment, investment and manufacturing capacity;

9. Expresses its strong support for the ‘polluters pay principle’ as laid down in Article 191(2) TFEU; supports the ambition of the directive in implementing this principle through the EPR scheme;

10. Expresses concern, nevertheless, that the current design of the EPR scheme may contribute to: – reduced availability of certain medicines; – reduced investment in pharmaceutical manufacturing; – production relocations outside the EU; – the loss of high-quality industrial employment;

11. Highlights the need to preserve and strengthen pharmaceutical manufacturing capacity, employment and supply chain resilience within the EU;

12. Stresses that the implementation of Directive (EU) 2024/3019 should be fully in line with the objectives of the Critical Medicines Act and the EU’s broader competitiveness agenda;

13. Calls on the Commission to commission a new, comprehensive, independent and methodologically robust study with peer review by early 2027 covering: – the actual costs of quaternary treatment; – the impact on municipalities and wastewater operators; – the impact on accessibility, availability and affordability of medicines; – the impact on employment, investment and industrial competitiveness; – the scientific basis for pollution attribution methodologies; – the effects on medicine availability, affordability and security of supply;

14. Calls on the Commission, on the basis of the findings of this study, to review the scientific methodology used for pollution attribution and the resulting allocation of costs under the EPR scheme, and to ensure that the implementation of the directive remains proportionate, evidence-based and consistent with the effective implementation of the polluters pay principle and the principles of fairness and legal certainty before the transposition is completed;

15. Calls for a temporary suspension of the EPR provisions (Articles 9 and 10) and related financial obligations until the completion of the study and the assessment of its findings by the Commission;

16. Requests that, should the results of the study demonstrate shortcomings in the current attribution methodology or cost allocation model, the Commission submit, without undue delay, the necessary legislative proposals to revise the EPR framework and ensure coherence with the objectives of public health, the Critical Medicines Act, industrial competitiveness and the security of supply of medicines;

17. Stresses the need for a level playing field between EU and non-EU manufacturers;

18. Supports the development of a more proportionate and substance-based approach to cost allocation where appropriate;

19. Calls for complementary financing mechanisms involving all relevant stakeholders to be explored, while ensuring a fair and sustainable framework for municipalities and wastewater operators;

20. Calls for the establishment of a permanent multi-stakeholder platform bringing together industry, municipalities, wastewater operators, regulators and public authorities;

21. Urges stronger coordination between environmental, health, industrial and competitiveness policies in future impact assessments and legislative initiatives;

22. Calls on the Commission to monitor the effects of implementation on medicine availability, industrial capacity and employment and to report regularly to Parliament and the Council;

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

24. Emphasises that future measures should remain science-based, technology-neutral, proportionate and patient-centred;

25. Instructs its President to forward this resolution to the Commission, the Council and the Member States.