Zentiva Calls for EU Pause on Urban Waste Water Treatment Directive
Zentiva has called for an EU-level “stop-the-clock” on the Urban Waste Water Treatment Directive (UWWTD), warning that its current structure threatens medicine availability across Europe. According to the company, the Directive’s implementation could disrupt the supply of affordable and essential medicines relied upon by millions of patients.
Following the adoption of the Urban Waste Water Treatment Directive, and despite objections from 16 EU Member States, Zentiva filed a legal action in 2025 seeking annulment. However, the General Court of the European Union ruled that generic and off-patent manufacturers are not individually affected under EU law. As a result, the Court did not assess the substance of the Directive, including whether its Extended Producer Responsibility (EPR) scheme is proportionate or compatible with EU law.
Why the Urban Waste Water Treatment Directive Raises Concerns
Under the current framework, the pharmaceutical and cosmetics industries must cover at least 80% of the costs of the fourth stage of wastewater treatment. While policymakers aim to strengthen environmental standards, Zentiva argues that the cost model does not reflect healthcare economics.
Because off-patent medicine prices are heavily regulated and often measured in cents per daily dose, manufacturers cannot absorb significant additional costs. Consequently, many essential medicines could become economically unsustainable to produce.
Moreover, the generics industry supplies around 70% of dispensed medicines and 90% of critical medicines across Europe. Therefore, any disruption linked to the Urban Waste Water Treatment Directive could increase the risk of medicine shortages in all 27 Member States.
Impact on Medicine Availability in Europe
Steffen Saltofte, CEO of Zentiva and President of Medicines for Europe, emphasized that the issue requires urgent political dialogue. He stated that implementation without correction may reduce access to affordable treatments and place additional pressure on healthcare systems.
Importantly, the Court’s ruling focused on procedural standing rather than evaluating whether the Directive’s cost-sharing model is workable or safe for medicine supply. Therefore, the practical consequences for patients remain unresolved.
What Zentiva Proposes Next
Zentiva is urging EU institutions to pause the current implementation of the Urban Waste Water Treatment Directive. Specifically, the company calls for:
-
An EU-level pause to allow structured dialogue among Member States, industry, healthcare systems, patients, and water operators.
-
Independent studies based on sound science and real-world healthcare economics.
-
A revised Directive that protects clean water goals without jeopardizing medicine availability, accessibility, or affordability.
Ultimately, Zentiva supports environmental responsibility. However, it stresses that sustainability policies must balance environmental protection with secure access to essential medicines across Europe.
Read Also: seqWell Launches MosaiX DNA Library Prep Kit for High-Performance NGS
