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

Amendments tabled for the plenary sitting on this text, in their own numbering series. This is a different set from the committee amendments tracked elsewhere on AmendEU, and is not counted in any of the site’s amendment totals.

1. Amendment 1PPEMotion for a resolution · Paragraph 6 a (new)
   Amendment

   6a. Calls on the Commission to produce an independent study by the end of 2026 identifying the list of substances present in urban wastewater, verifying the costs of quaternary treatment, providing an attribution between 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, and to, if necessary on the basis of the study results, accelerate the evaluation of the allocation of substances; considers that the Member States should be appropriately involved in the study, within their areas of competence, through the Pharmac…

   Excerpt — full text in the official PDF.
   official amendment document ↗
2. Amendment 2PPEMotion for a resolution · Paragraph 6 b (new)
   Amendment

   6b. Considers that, should the results of the study demonstrate the need for stronger or additional measures at EU level to ensure the accessibility, affordability and availability of medicines, the Commission should swiftly propose such measures, including a temporary suspension, a new form of cost-sharing, while respecting the ‘polluters pays’ principle, and more flexibility for the Member States to take into account their respective industries;

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3. Amendment 3PPEJoint motion for a resolution · Paragraph 10
   Current text

   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;

   Amendment

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

   official amendment document ↗
4. Amendment 4ECRJoint motion for a resolution · Recital M a (new)
   Amendment

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

   official amendment document ↗
5. Amendment 5ECRJoint motion for a resolution · Recital M b (new)
   Amendment

   Mb. 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);

   official amendment document ↗
6. Amendment 6ECRJoint motion for a resolution · Recital Q a (new)
   Amendment

   Qa. 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 strateg…

   Excerpt — full text in the official PDF.
   official amendment document ↗
7. Amendment 7ECRJoint motion for a resolution · Paragraph 6
   Current text

   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…

   Amendment

   6. Calls on the Commission to produce a new impact assessment 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…

   Excerpt — full text in the official PDF.
   official amendment document ↗
8. Amendment 8ECRJoint motion for a resolution · Paragraph 8
   Current text

   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 fu…

   Amendment

   8. Calls for a temporary suspension (‘stop the clock’) of the EPR provisions and of the quaternary treatment obligations and related financial obligations until the completion of the study and the assessment of its findings by the Commission;

   Excerpt — full text in the official PDF.
   official amendment document ↗
9. Amendment 9ECRJoint motion for a resolution · Paragraph 1
   Current text

   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;

   Amendment

   Reaffirms its strong support for the environmental objectives of the revised UWWTD and underlines the need to reduce water pollution;

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10. Amendment 10ECRJoint motion for a resolution · Paragraph 13
    Current text

    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;

    Amendment

    13. Notes 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;

    official amendment document ↗