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

B100278/2026

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 3(3) of the Treaty on European Union and Articles 9, 11, 168, 173, 191 and 192 of the Treaty on the Functioning of the European Union,

–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 (Urban Wastewater Treatment Directive), 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 its resolution of 7 May 2025 on the European Water Resilience Strategy,

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

–having regard to the report of 10 December 2025 by the Commission’s Joint Research Centre entitled ‘Updated estimation of the costs of quaternary wastewater treatment in the EU’,

–having regard to the Strategic Report of the Critical Medicines Alliance, published on 28 February 2025,

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

–having regard to the question to the Commission the implementation of the Urban Wastewater Treatment Directive and risks to the security of supply of medicines (O-000013/2026 – B100008/2026),

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

A.whereas the Urban Wastewater Treatment Directive aims to reduce water pollution, including via micropollutants, and protect water quality across the EU;

B.whereas the directive introduces quaternary treatment and an Extended Producer Responsibility (EPR) scheme requiring the pharmaceutical and cosmetic sectors to finance a significant share of the cost of such treatment (at least 80 % and up to 100 %);

C.whereas the introduction of quaternary treatment is the costliest feature of the directive;

D.whereas Member States’ cost estimates significantly exceed those provided in the Commission’s impact assessment (e.g. Germany and Spain have reported costs several times higher);

E.whereas the Commission’s attribution of approximately 92 % of the micropollutant load to pharmaceuticals and cosmetics has been questioned on methodological and scientific grounds, in particular given the lack of a thorough analysis of the consequences for patient access and national healthcare budgets; whereas this omission is especially critical for the entire pharmaceutical ecosystem, encompassing innovative, generic and off-patent medicines, which collectively underpins patient access, security of supply and the long-term sustainability of European healthcare systems, while sustaining the investment in research and development and the manufacturing footprint on which Europe’s strategic autonomy in health depends;

F.whereas many micropollutants from medicinal products originate from patient use, rather than production or disposal;

G.whereas the EPR scheme may have limited incentive effects in the pharmaceutical sector as a result of regulatory constraints on reformulation and patient safety considerations;

H.whereas pharmaceutical manufacturers, particularly producers of generics, operate under strict pricing frameworks and with low margins, limiting their ability to absorb additional regulatory costs;

I.whereas generic and offpatent medicines account for nearly 70 % of medicines dispensed in the EU and are essential for healthcare system sustainability and national healthcare budgets;

J.whereas medicine shortages in the EU have worsened in recent years and pose serious risks to patient care;

K.whereas the EU remains highly dependent on non-EU countries for active pharmaceutical ingredients;

L.whereas additional regulatory burdens risk accelerating the relocation of manufacturing to outside the EU, thereby undermining resilience and strategic autonomy;

M.whereas there is still uncertainty regarding how imported products will comply with and finance EPR obligations;

N.whereas Member States and stakeholders have raised concerns about the proportionality, legal design and administrative burden of the EPR scheme;

O.whereas environmental legislation must remain proportionate, evidence-based and coherent with public health and industrial policy objectives;

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

1.Reaffirms its strong support for the environmental objectives of the Urban Wastewater Treatment Directive and underlines the need to reduce water pollution;

2.Stresses that environmental legislation must not undermine public health objectives, patient safety, or access to essential medicines;

3.Underlines the importance of both the pharmaceutical and cosmetic industries for Europe’s competitiveness and resilience;

4.Expresses deep concern that the cost estimates for quaternary treatment are significantly higher than initially projected;

5.Questions the robustness of the methodology used to attribute pollution loads and allocate costs across sectors;

6.Notes that existing assessments fail to adequately address the impact on the availability of medicines, particularly generic and offpatent medicines;

7.Warns that the current design of the EPR scheme risks increasing medicine prices, reducing the availability of essential medicines and accelerating the relocation of production outside the EU;

8.Stresses that medicine shortages are already a major and growing challenge in the EU;

9.Highlights the need to safeguard EU pharmaceutical manufacturing capacity and supply chain resilience;

10.Calls on the Commission to carry out a new, comprehensive, independent and methodologically robust impact assessment covering the real costs of quaternary treatment, the sector-specific impact on pharmaceuticals (particularly on generic and offpatent medicines), a reassessment of the attribution of pollution, and the effects on medicine availability and affordability;

11.Invites the Commission to reassess the scientific basis for the allocation of costs and ensure proportionality;

12.Calls for the temporary suspension (‘stop-the-clock’) of quaternary treatment obligations and EPR provisions for a period of two years, and until the new impact assessment has been completed;

13.Requests that the Commission submit a legislative proposal to implement this suspension;

14.Calls on the Commission to clarify how non-EU producers will comply with EPR obligations, in order to avoid competitive distortions;

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

16.Supports a substance-based and proportionate approach to cost allocation;

17.Calls for the exploration of alternative or complementary financing mechanisms involving all relevant pollution sources, including wastewater operators;

18.Calls for the establishment of a permanent multi-stakeholder platform involving representatives from industry, regulators and the public authorities;

19.Urges stronger coordination between environmental, health and industrial policies, including in Commission impact assessments;

20.Calls on the Commission to monitor the impact of EPR on medicine availability and report on this regularly;

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

22.Emphasises that future measures must be science-based, technology-neutral and patient-centred;

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