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Zentiva's Urgent Call to Action for Drug Availability in Europe

Zentiva, a prominent manufacturer of high-quality and affordable medicines in Europe, has recently taken significant actions in response to the European Union Court's ruling regarding the Urban Waste Water Treatment Directive (UWWTD). The company emphasizes that the current form of the UWWTD poses a serious threat to the secure supply of essential medicines throughout Europe.

In 2025, despite the clear concerns articulated by 16 EU member states, Zentiva filed a lawsuit requesting the annulment of this directive, aiming to guarantee the safety of patients who depend daily on crucial medicines. The recent court ruling has specified how judicial standing is interpreted under EU law, stating that Zentiva and other generic and off-patent drug manufacturers are not considered directly affected, thus lacking the legal capacity to contest the directive in court. This decision has raised significant alarm given the far-reaching implications for the pharmaceutical sector and the medications supplied by Zentiva across Europe.

Steffen Saltofte, CEO of Zentiva and president of Medicines for Europe, voiced his concerns about the UWWTD directive. He pointed out that the foundation of the UWWTD is derived from evaluations that have been scientifically refuted multiple times. Despite this, the directive mandates the pharmaceutical and cosmetics industries to cover at least 80% of the costs related to wastewater treatment in the fourth stage of purification. He stressed the challenge this brings for the off-patent drug industry, whose prices are largely regulated, with daily doses often costing just a few cents.

Saltofte highlighted the dire consequences of implementing the directive without any amendments. It threatens the economic viability of producing many essential medicines, which would consequentially restrict patient access to affordable treatments and increase the risk of drug shortages.

The court's decision has not addressed the long-standing issues related to the UWWTD; rather, it has underscored the need for a political and regulatory fix before its full implementation can cause irreparable harm. The generic drug sector represents 70% of all dispensed medicines and covers nine out of ten critical medications. If no corrective actions are taken and the directive is enacted as is in 27 countries, it will likely lead to severe shortages in medications.

In his remarks, Saltofte further stated, "As the CEO of a Europe-based company and as president of Medicines for Europe, I will not sit idly by. We will continue to demand a solution that needs to be collaboratively developed — not in isolation and not without industry involvement - to ensure this matter is addressed comprehensively. We need all stakeholders to come together to pause the implementation, correct the directive at the EU level, and restart it in a feasible manner that ensures clean water without compromising the availability, accessibility, and affordability of healthcare."

The Next Steps Required

Following the directive's approval, the need for effective political leadership and dialogue has become more urgent than ever. Zentiva is advocating for:

• - A temporary suspension of the ongoing UWWTD implementation at the EU level to foster inclusive dialogue among EU institutions, member states, water operators, patients, health systems, and industry stakeholders.
• - The execution of new independent studies as part of a necessary correction to the directive, focusing on robust scientific foundations, proportionality, and real healthcare economic conditions to assess impacts on the availability, accessibility, and affordability of medicines.
• - A restart of the directive in a practical form that allows for clean water without jeopardizing the availability, accessibility, and affordability of medicines for patients across Europe.

About Zentiva

Zentiva is dedicated to promoting health and wellness for all generations and focuses on developing, manufacturing, and delivering high-quality, affordable medicines to over 100 million people across more than 40 countries in Europe and beyond. With four owned manufacturing facilities and a robust network of external production partners, Zentiva is committed to ensuring supply security. The company employs over 5,400 talented individuals who share a commitment to serving those who rely on their medications daily. You can learn more about Zentiva on their website: www.zentiva.com.