Zentiva takes legal action and challenges Urban Wastewater Treatment Directive to protect access to affordable healthcare for millions of people

BRUSSELS and PRAGUE, March 10, 2025 /PRNewswire/ -- Zentiva has filed a legal case with the Court of Justice of the European Union challenging the Urban Wastewater Treatment Directive (UWWTD) to safeguard access to affordable medicines in Europe. The implementation of the Directive will lead to medicine shortages, leaving people behind who depend on those products every day.

In late 2024, the European Union adopted a significant update to the UWWTD. This revision aims to align the Directive with the Green Deal, addressing contemporary issues such as micropollutants and introducing the Extended Producer Responsibility (EPR) scheme. The Directive enforces the polluter pays principle, specifically requiring the pharmaceutical and cosmetic industries to finance the new quaternary treatment processes at urban wastewater treatment plants to remove these micropollutants. 16 out of 27 Member States of the European Union raised concerns about the Directive's impact on medicines. Zentiva is challenging the funding mechanism under the Directive, which imposes an unsustainable financial burden on the pharmaceutical industry, threatening the economic viability of needed medicines.

Steffen Saltofte, CEO Zentiva, explained: "Europe needs legislation that works. As a leading European company dedicated to developing, producing, and supplying high-quality and affordable medicines, we view the Directive as discriminatory and disproportionate. Clean water is essential for our lives and the production of medicines. We support the Green Deal and the ambition of the UWWTD, but we cannot accept the current implementation plan. We are 100% committed to paying our fair share. But the Directive results in an astronomical additional tax with a disproportionate burden on the generics industry. We cannot finance that while operating within a highly regulated framework."

Generics account for 70% of all medicines sold in Europe, representing only 19% of the market value, thus making a significant contribution to public health. The role of generics is to expand access to healthcare and secure health outcomes, while helping healthcare decision-makers finance sustainable healthcare.

Steffen Saltofte continued: "We view the Directive as violating key principles of the European Union. There is no transparency, as we still lack access to the data and methodology used by the European Commission in deciding to make only pharmaceutical and cosmetics industries responsible for the costs of treating urban wastewater. Concerns from many partners remain unheard. This is why we are pursuing legal action to contest the Directive, which endangers the continuous supply of medicines to people. Implementing the Directive in its current form will make many products economically unviable, forcing them off the market and leaving behind the people who depend on these products every day.

"As a company, we invest in decarbonizing our operations and have our own wastewater treatment plants installed at our premises. We must comply with numerous regulations to maintain the high-quality and safety of our products, our prices are regulated, and investments in environmental innovation are not rewarded.

"Zentiva calls on the European Commission and Member States to reassess the Directive's impact. We need an urgent dialogue with EU policymakers and all stakeholders to find an appropriate and equitable solution for ensuring clean water without jeopardizing access to affordable healthcare in Europe. We believe that access to healthcare should be a right for all, not just a privilege."

About Zentiva

Zentiva provides health and wellbeing for all generations. We are a European company developing, producing, and delivering high-quality, affordable medicines to more than 100 million people in over 30 countries across Europe and beyond. Zentiva has four wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. The company is private equity-owned, delivering sustainable growth, with an ambitious plan for the years to come.

We are a team of more than 5,000 unique talents bonded together by our commitment to ensuring the supply of high-quality, affordable medicines to people who depend on them every day. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated, and can be their true selves, contributing to the best of their ability.

Our roots reach back more than 500 years to a small pharmacy in Prague that still exists today. We act today for a sustainable tomorrow, so that Zentiva will continue to provide health and wellbeing for all generations for at least another 500 years.

Learn more about Zentiva www.zentiva. [https://www.zentiva.com/]com.

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CONTACT: Media contact: Ines Windisch, Head of Communications, Corporate Affairs & Sustainability, ZENTIVA GROUP, a.s., cell: (+420) 601 341 444, ines.windisch@zentiva.com