Changes from resolution motion to resolution motion joint

AddedT. 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;

Removed5. Questions the robustness of the methodology used to attribute pollution loads and allocate costs across sectors;

AddedU. 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;

Removed6. Notes that existing assessments fail to adequately address the impact on the availability of medicines, particularly generic and offpatent medicines;

AddedV. 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;

Removed7. 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;

AddedW. 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;

Removed8. Stresses that medicine shortages are already a major and growing challenge in the EU;

AddedX. 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;

Removed9. Highlights the need to safeguard EU pharmaceutical manufacturing capacity and supply chain resilience;

AddedY. 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;

Removed10. 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;

AddedZ. 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;

Removed11. Invites the Commission to reassess the scientific basis for the allocation of costs and ensure proportionality;

AddedAA. 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;

Removed12. 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;

AddedAB. 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;

Removed13. Requests that the Commission submit a legislative proposal to implement this suspension;

AddedAC. 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;

Removed14. Calls on the Commission to clarify how non-EU producers will comply with EPR obligations, in order to avoid competitive distortions;

AddedAD. 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;

Removed15. Stresses the need for a level playing field between EU and non-EU manufacturers;

AddedAE. 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;

Removed16. Supports a substance-based and proportionate approach to cost allocation;

AddedAF. 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;

Removed17. Calls for the exploration of alternative or complementary financing mechanisms involving all relevant pollution sources, including wastewater operators;

Added1. 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;

Removed18. Calls for the establishment of a permanent multi-stakeholder platform involving representatives from industry, regulators and the public authorities;

Added2. 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;

Removed19. Urges stronger coordination between environmental, health and industrial policies, including in Commission impact assessments;

Added3. 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;

Removed20. Calls on the Commission to monitor the impact of EPR on medicine availability and report on this regularly;

Added4. 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;

Removed21. Supports research and innovation in environmentally sustainable pharmaceuticals and advanced wastewater treatment technologies;

Added5. 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;

Removed22. Emphasises that future measures must be science-based, technology-neutral and patient-centred;

Added6. 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;

Removed23. Instructs its President to forward this resolution to the Commission, the Council and the Member States.

Added7. 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;

Added8. 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;

Added9. 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;

Added10. 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;

Added11. 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;

Added12. 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;

Added13. 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;

Added14. 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;

Added15. Supports research and innovation in environmentally sustainable pharmaceuticals and in advanced wastewater treatment technologies;

Added16. 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;

Added17. Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.