Pharmaceutical industry groups warn of EU wastewater directive impacts

Seven industry organizations, including Farmaindustria, AELMHU, and STANPA, have released a technical report prepared with PwC regarding the implications of EU Directive 2024/3019 on urban wastewater treatment. The report highlights regulatory, economic, and operational challenges arising from the new directive.

The directive mandates the progressive implementation of quaternary treatment to remove microcontaminants from urban wastewater. Under a new Extended Producer Responsibility (EPR) regime, at least 80% of these treatment costs will be transferred to producers of human medicines and cosmetic products. While the associations support the environmental goals of improving water quality, they argue that the current EPR design violates the ‘polluter pays’ principle and contradicts principles of proportionality and non-discrimination.

In Spain, the directive must be transposed by July 31, 2027, with the EPR regime fully implemented by December 31, 2028. The organizations are calling for a balanced and legally secure transposition based on scientific evidence.

Separately, European pharmaceutical and healthcare organizations, including the PGEU and EAHP, have issued a joint statement regarding the Digital Omnibus framework. They are calling on EU legislators to ensure that regulatory simplification does not weaken the protection of personal health data or compromise the use of artificial intelligence in the healthcare sector.