Source: European Parliament
Question for written answer E-002108/2025
to the Commission
Rule 144
Christine Anderson (ESN)
The revised[1] Urban Wastewater Treatment Directive[2] (UWWTD) may significantly increase production costs for essential, low-cost medicines such as Metformin, a key treatment for type two diabetes used by nearly three million patients in Germany[3].
Estimates suggest that pharmaceutical and cosmetic companies are required to cover at least 80 % of the costs (Article 9) of additional treatment to remove micropollutants in order to comply with the directive. This could lead to a cost increase of up to 445 % for Metformin production. Manufacturers warn that this would make the continued EU-based production of such medicines unviable, risking market withdrawals, medicine shortages and greater dependence on non-EU imports.
- 1.Can the Commission confirm whether the estimate of up to a 445 % cost increase for Metformin is accurate, and whether it anticipates similar effects across other Member States and medicines, particularly for low-margin generics?
- 2.How does the Commission reconcile the provisions of the UWWTD, specifically the mandatory cost allocation under Article 9(4), with the objectives of the proposed Critical Medicines Act, which aims to strengthen EU production and supply security for essential pharmaceuticals?
- 3.Given the risk to medicine affordability and availability, does the Commission consider a targeted revision or exemption within the UWWTD necessary in order to safeguard public health and pharmaceutical resilience?
Submitted: 26.5.2025
- [1] COM(2022)0541.
- [2] Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment, OJ L, 2024/3019, 12.12.2024, ELI: http://data.europa.eu/eli/dir/2024/3019/oj.
- [3] Der Spiegel, https://www.spiegel.de/wirtschaft/diabetes-medikament-metformin-droht-das-aus-hohe-kosten-durch-eu-abwasserrichtlinie-a-25ab387e-8ef2-43c7-a9e0-7714d850aeb3.