EU Wastewater Directive Risks Medicine Shortages: Zentiva Reacts | 2026 Update

A new European Union directive aimed at improving wastewater treatment is raising concerns within the pharmaceutical industry about potential shortages of essential medicines. The directive, known as the Urban Waste Water Treatment Directive (UWWTD), requires pharmaceutical and cosmetic companies to cover at least 80% of the costs associated with a fourth, more advanced stage of wastewater purification – designed to remove micropollutants like pharmaceutical residues.

Zentiva, a leading European manufacturer of generic medicines, has been vocal in its opposition to the directive, arguing that the financial burden it imposes is unsustainable, particularly for manufacturers of off-patent drugs. The company recently pursued legal action in 2025 seeking the annulment of the directive, but the General Court of the European Union ruled on February 23, 2026, that Zentiva and similar manufacturers do not have standing to directly challenge the directive, despite the significant impact It’s expected to have on their operations.

The court’s decision focused on legal standing rather than the substance of the case. Importantly, the court did not assess whether the Extended Producer Responsibility (EPR) scheme within the UWWTD is compatible with EU law, or whether the cost model is feasible, proportionate, or safe for ensuring a continuous supply of medicines. This leaves the core concerns raised by Zentiva and other industry stakeholders unaddressed.

“The UWWTD Directive has been approved and is already in the implementation phase,” stated Steffen Saltofte, CEO of Zentiva and President of Medicines for Europe. “It is based on an assessment that has been scientifically refuted multiple times, but it requires the pharmaceutical and cosmetics industries to cover at least 80% of the costs of wastewater treatment during the fourth treatment phase. We knew from the outset that this was not possible for the off-patent drug industry. Our prices are mostly regulated and the price of a daily dose of a non-patented medicine is of the order of a euro cent. We simply cannot absorb these costs.”

The concern stems from the narrow profit margins inherent in the generic drug market. Off-patent medicines, which constitute approximately 70% of all medicines dispensed in Europe, including nine out of ten essential medicines, are often priced very low due to regulatory controls and market competition. The added expense of wastewater treatment, as currently structured in the UWWTD, could render the production of many essential medicines economically unviable.

This potential economic impact translates directly to patient access. If manufacturers are unable to absorb the increased costs, they may be forced to discontinue production of certain medications, leading to shortages and limiting access to affordable treatments across the EU. The potential for medicine shortages is particularly concerning given recent supply chain disruptions experienced in Europe.

Zentiva emphasizes that the issue isn’t about opposing environmental protection, but rather about finding a sustainable and workable solution. The company argues that the current directive fails to adequately consider the economic realities of the off-patent medicine industry and the potential consequences for public health.

Saltofte further stated, “As the CEO of a European company and president of Medicines for Europe, which represents the off-patent medicines industry, I will not stand idly by in the face of this situation. We will continue to insist on a solution to be developed together, not in isolation, and not without the industry. This issue requires that all stakeholders come together at the same table to suspend the implementation of the directive, revise it at EU level and relaunch it in a viable manner across Europe, ensuring clean water without compromising the availability, accessibility and affordability of healthcare for the people who depend on these medicines in Europe every day.”

Zentiva is calling for a pause in the implementation of the UWWTD to allow for a more inclusive dialogue between EU institutions, Member States, water sector operators, patients, healthcare systems, and industry representatives. They also advocate for new, independent studies to assess the impact of the directive on medicine availability, accessibility, and affordability, based on robust scientific data and a realistic understanding of healthcare economics.

The company believes that a revised directive can achieve the goal of cleaner water without jeopardizing the supply of essential medicines. The key, they argue, is a collaborative approach that considers the unique challenges faced by the off-patent pharmaceutical industry and prioritizes the needs of patients across Europe.

The directive is already in the process of being implemented at the national level, making swift political action and open dialogue increasingly urgent. The outcome of this situation will likely have significant implications for the future of medicine access and environmental policy in the European Union.

Zentiva ensures the health and well-being of all generations, focusing on the development, production and distribution of high-quality, affordable medicines to more than 100 million people in more than 40 countries across Europe and beyond. Zentiva employs more than 5,400 people.