Pharma Companies Sue Over European Wastewater Directive

Pharma Deutschland and seven of its member companies have initiated legal proceedings at the European Union's Court of Justice against the new directive concerning urban wastewater treatment (Urban Waste Water Treatment Directive). Dermapharm, Fresenius-Kabi, hameln pharma, PUREN Pharma, Sandoz/Hexal, Teva, and ZENTIVA Pharma have filed lawsuits, with Pharma Deutschland acting as an intervener to support its member companies legally.

The directive primarily addresses wastewater from households, which contains trace substances, including breakdown products of pharmaceuticals. The challenging companies argue that a central aspect of the directive, known as extended producer responsibility, violates existing EU law. This responsibility mandates that at least 80% of the costs for the construction and operation of an additional treatment stage at municipal wastewater treatment plants should be borne by manufacturers of human pharmaceuticals and cosmetics.

Dorothee Brakmann, CEO of Pharma Deutschland, criticized the directive's underlying assumptions and implementation. "The directive has significant flaws in its fundamental assumptions, data basis, operational implementation, and cost estimates," Brakmann stated. She warned that the directive could jeopardize the pharmaceutical supply and economic competitiveness in Germany and Europe.

The companies contend that the extended producer responsibility cannot be justified under the 'polluter pays' principle enshrined in the EU Treaty on the Functioning of the European Union. They argue that the cost allocation will not incentivize manufacturers to switch to more ecological products, as the effect of pharmaceuticals is tied to their active ingredients. Furthermore, they point out that not all trace substances in urban wastewater originate solely from pharmaceuticals or cosmetics.

The companies fear that the new financial burden could make the sale of many medicines unprofitable in Germany and Europe. Brakmann warned that this could lead to supply chain disruptions and contradict the EU's strategic goals of ensuring a stable pharmaceutical supply and reducing reliance on external sources.