Zentiva Calls for Suspension of EU Wastewater Directive to Safeguard Medicine Availability
On February 24, 2026, Zentiva, a prominent European manufacturer of high-quality, affordable medications, expressed its concerns in response to a recent ruling by the European Union Court regarding the Urban Wastewater Treatment Directive (UWWTD). The company has reiterated that the current form of the UWWTD poses a significant risk to the reliable supply of essential medicines across Europe. Following the adoption of the directive—despite serious concerns raised by 16 EU member states—Zentiva filed a lawsuit in 2025 seeking to annul the directive to ensure a continuous supply of fundamental medicines for patients who depend on them daily.
The recent court decision clarified how the EU judicial system interprets legal standings. The conclusion indicated that Zentiva and other producers of generic and off-patent medicines do not hold individual standing in contesting the directive directly. This remains significant despite the real and substantial impact the directive has on the sector and the medicines supplied throughout Europe.
Critically, the Court did not evaluate the substance of the matter, including whether the Extended Producer Responsibility (EPR) system mandated by the UWWTD aligns with EU law or whether the cost model is feasible, reasonable, or safe for ensuring consistent drug supplies.
Steffen Saltofte, CEO of Zentiva and President of Medicines for Europe, remarked, "The UWWTD directive was approved and is now in the implementation phase. It is based on assessments that have been scientifically disproven multiple times; nevertheless, it burdens the pharmaceutical and cosmetic industries with covering at least 80% of the costs for wastewater cleaning in the fourth purification stage. From the outset, we understood this was unfeasible for the over-the-counter medication sector. Prices of our products are largely regulated, and a daily dose of our over-the-counter medications often costs just a few cents. These costs are simply unsustainable for us."
If the directive is implemented without modifications, the production of numerous essential medications may cease to be economically viable. Such an outcome would directly affect patients in all EU member states, reducing access to affordable treatment options and increasing the risk of drug shortages. Ultimately, patients would bear the financial brunt.
The Court's ruling leaves these long-standing problems unaddressed—it overlooks the essence of the directive and its practical implications, thus intensifying the need for policy-level remedies before full execution inflicts damage.
Generic medicines account for 70% of all prescriptions and 9 out of 10 critical medications. If no further action is taken and the directive, in its current form, is transposed into national law across the 27 countries, a massive shortage of medications is highly probable.
Saltofte further asserted, "As the CEO of a company based in Europe and the President of Medicines for Europe, representing the off-patent medicine sector, I will not stand idle as this unfolds. We will continue to advocate for a solution that we must develop together, not in isolation, and not without industry involvement. Addressing this issue requires all stakeholders to come together, suspend the implementation, rectify it at the EU level, and restart it in a functional manner throughout Europe to ensure clean water without compromising the accessibility and affordability of healthcare for the European populace who depend on these medications every day."
Next Steps
The directive has been adopted and is entering into the national implementation phase, making political leadership and dialogue more urgent now than ever.
Zentiva is calling for:
About Zentiva
Zentiva is dedicated to the health and well-being of all generations, primarily focusing on the development, manufacturing, and delivery of high-quality, affordable medications for more than 100 million people in over 40 countries across Europe and beyond. Zentiva operates four manufacturing plants and a wide network of external manufacturing partners to ensure supply safety. The company employs over 5,400 talented individuals united by a commitment to the people who rely on its medicines every day. For more information, visit us at www.zentiva.com.
The recent court decision clarified how the EU judicial system interprets legal standings. The conclusion indicated that Zentiva and other producers of generic and off-patent medicines do not hold individual standing in contesting the directive directly. This remains significant despite the real and substantial impact the directive has on the sector and the medicines supplied throughout Europe.
Critically, the Court did not evaluate the substance of the matter, including whether the Extended Producer Responsibility (EPR) system mandated by the UWWTD aligns with EU law or whether the cost model is feasible, reasonable, or safe for ensuring consistent drug supplies.
Steffen Saltofte, CEO of Zentiva and President of Medicines for Europe, remarked, "The UWWTD directive was approved and is now in the implementation phase. It is based on assessments that have been scientifically disproven multiple times; nevertheless, it burdens the pharmaceutical and cosmetic industries with covering at least 80% of the costs for wastewater cleaning in the fourth purification stage. From the outset, we understood this was unfeasible for the over-the-counter medication sector. Prices of our products are largely regulated, and a daily dose of our over-the-counter medications often costs just a few cents. These costs are simply unsustainable for us."
If the directive is implemented without modifications, the production of numerous essential medications may cease to be economically viable. Such an outcome would directly affect patients in all EU member states, reducing access to affordable treatment options and increasing the risk of drug shortages. Ultimately, patients would bear the financial brunt.
The Court's ruling leaves these long-standing problems unaddressed—it overlooks the essence of the directive and its practical implications, thus intensifying the need for policy-level remedies before full execution inflicts damage.
Generic medicines account for 70% of all prescriptions and 9 out of 10 critical medications. If no further action is taken and the directive, in its current form, is transposed into national law across the 27 countries, a massive shortage of medications is highly probable.
Saltofte further asserted, "As the CEO of a company based in Europe and the President of Medicines for Europe, representing the off-patent medicine sector, I will not stand idle as this unfolds. We will continue to advocate for a solution that we must develop together, not in isolation, and not without industry involvement. Addressing this issue requires all stakeholders to come together, suspend the implementation, rectify it at the EU level, and restart it in a functional manner throughout Europe to ensure clean water without compromising the accessibility and affordability of healthcare for the European populace who depend on these medications every day."
Next Steps
The directive has been adopted and is entering into the national implementation phase, making political leadership and dialogue more urgent now than ever.
Zentiva is calling for:
- - A suspension of the current implementation of the UWWTD across the EU to allow for an inclusive dialogue among EU institutions, member states, water service operators, patients, healthcare systems, and the industry.
- - The conduct of new independent studies necessary for the repair of the directive based on reliable scientific insights, proportionality, and the real economics of healthcare, to assess the effects on the availability, accessibility, and affordability of medicines.
- - The reintroduction of the directive in a feasible format ensuring clean water without jeopardizing the availability, accessibility, and affordability of medicines for patients across Europe.
About Zentiva
Zentiva is dedicated to the health and well-being of all generations, primarily focusing on the development, manufacturing, and delivery of high-quality, affordable medications for more than 100 million people in over 40 countries across Europe and beyond. Zentiva operates four manufacturing plants and a wide network of external manufacturing partners to ensure supply safety. The company employs over 5,400 talented individuals united by a commitment to the people who rely on its medicines every day. For more information, visit us at www.zentiva.com.
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