Newsroom News At Zentiva, we provide health and wellbeing for all generations Zentiva appeals EU court decision on Urban Wastewater Directive Appeal defends patient access, affordability of medicines and fundamental EU legal principles Newsroom Prague / Brussels, 27 April 2026 – The EU Urban Wastewater Treatment Directive (UWWTD) continues to raise serious concerns. Zentiva and other companies in the off patent medicines sector have therefore filed an appeal before the Court of Justice of the European Union (CJEU), which seeks to set aside an earlier order of inadmissibility and enable substantive judicial review following annulment action brought by the companies in March 2025.Through Council statements and EPSCO* debates, 24 of the 27 EU Member States have raised concerns, expressed doubts, or requested further clarification on the Directive or its impacts. Despite this, the Directive is now being implemented at national level. The Directive in its current form poses a serious risk to the availability, affordability, and accessibility of medicines across Europe - on which millions of people depend every day. The companies therefore request a pause, repair and relaunch of the Directive.Zentiva, a leading European manufacturer of generic medicines, fully supports the objective of further reducing micropollutants in urban wastewater, but strongly rejects the extended producer responsibility (EPR) scheme as a disproportionate and unjustified application of the “polluter pays” principle. Micropollutants originate from a wide range of industrial and consumer sources -not only from the use of human medicines and cosmetics. The EPR scheme would mean that medicine and cosmetics producers have to pay for the removal of micropollutants not caused by them while other producers will not bear any cost. Overall, the EPR scheme violates the “polluter pays” principle and risks undermining patient access to essential medicines, placing a disproportionate burden on the generic medicines sector – the backbone of European healthcare – without delivering meaningful environmental benefits. Etiam malesuada tempus viverra Generic medicines account for around 70% of all medicines dispensed in Europe and nine out of ten medicines on the EU list of critical medicines (IQVIA, 2024). These medicines make a significant contribution to public health. Yet generic manufacturers operate under strict price regulation and very low margins. Unlike other industries, they cannot increase prices to absorb additional costs due to statutory price and reimbursement controls in most Member States.Independent studies in several countries  indicate that the costs of the UWWTD have been significantly underestimated, creating a risk of medicine shortages, higher healthcare costs, and a loss of competitiveness for an entire industry sector.While fully committed to protecting the environment, Zentiva highlights that the UWWTD’s EPR scheme does not incentivise “greener” medicines. Under the current regulatory framework, medicines cannot be reformulated within meaningful timelines or replaced without many years of research, regulatory approval, and patient safety assessments. As a result, the Directive risks increasing costs without delivering corresponding environmental benefits, while creating negative consequences for patients and healthcare systems.The appeal seeks to set aside the General Court’s order of inadmissibility and to enable substantive judicial review following the annulment action brought by Zentiva and other companies in March 2025. Through this annulment action, Zentiva challenges Articles 9 and 10, in conjunction with Annex III of the UWWTD, which establish the extended producer responsibility (EPR) by allocating at least 80% of the costs of the new, so called quaternary wastewater treatment to pharmaceutical and cosmetic producers.Despite being directly and individually affected, Zentiva and other generic companies were denied the opportunity to have the substance of their case heard. Zentiva seeks judicial review of the Directive to ensure compliance with fundamental EU legal principles, while safeguarding continued patient access to affordable medicines.Zentiva remains firmly committed to environmental responsibility. According to EcoVadis 2025, its sustainability program ranks among the top 2% of the pharmaceutical industry.*Employment, social policy, health and consumer affairs council – a meeting of national government ministers.  Zentiva provides health and wellbeing for all generations, with focus on developing, producing, and delivering high-quality, affordable medicines to more than 100 million people in over 40 countries across Europe. Zentiva has four manufacturing sites and a broad network of external manufacturing partners to ensure supply security. Zentiva employs more than 5,400 unique talents in over 30 countries, bonded together by a commitment to the people who depend on our products every day. Visit us at www.zentiva.com or on LinkedIn About Zentiva Newsroom

Zentiva appeals EU court decision on Urban Wastewater Directive

2026-04-27-uwwtd

Newsroom News At Zentiva, we provide health and wellbeing for all generations Zentiva Demands EU‑Level Stop‑the‑Clock on the UWWTD to Protect Medicine Availability Newsroom Prague, 23 February 2026 – Zentiva, a leading European manufacturer of high‑quality and affordable medicines, responds to the decision of the General Court of the European Union concerning the Urban Waste Water Treatment Directive (UWWTD) reiterating that the UWWTD, in its current form, poses a significant risk to the secure supply of essential medicines in Europe.Following the adoption of the Directive, despite major concerns raised by 16 EU Member States, in 2025 Zentiva filed a legal action to request annulment of the Directive to safeguard the secure supply of essential medicines for the patients who depend on them every day.The recent decision clarifies how the Court interprets legal standing under EU law. It concludes that Zentiva and other generic and off patent medicine manufacturers are not considered individually affected, and therefore do not have a direct judicial route to challenge the Directive - even though its impact on the sector and on the medicines we supply across Europe is real and substantial. Importantly, the Court did not assess the substance of the case - including whether the Extended Producer Responsibility (EPR) scheme under the UWWTD is compatible with EU law or whether the cost model is workable, proportionate, or safe for securing the continuity of medicine supply. Etiam malesuada tempus viverra If implemented without correction, the Directive may render many essential medicines economically unsustainable to produce. The result would directly affect patients across all EU Member States, reducing access to affordable treatments and increasing the risk of medicine shortages. Ultimately, patients would pay the price. The Court outcome does not resolve these long standing issues - it leaves the substance of the Directive and its practical impact unaddressed, reinforcing the need for a political and policy‑level correction before full implementation causes harm.The generics industry counts for 70% of all dispensed medicines, and 9 out of 10 critical medicines. If no further measures are taken and the Directive in its current form is transposed into national legislation across 27 countries, it is highly likely to lead to massive shortages. Saltofte further commented: “As the CEO of a European-based company and President of Medicines for Europe, the representation of the off-patent medicine industry, I will not sit back and watch this happen. We will continue to insist on a solution that we must develop together - not in silos, and not without industry. This issue requires all stakeholders at one table to pause the implementation, repair it at EU level, and relaunch it in a workable way across Europe - ensuring clean water without jeopardizing the availability, accessibility, and affordability of healthcare for the people in Europe who depend on these medicines every day.”What needs to happen nextThe Directive has been adopted and is entering national implementation, making political leadership and dialogue more urgent than ever. Zentiva calls for:A pause in the current implementation of the UWWTD at EU level, allowing an inclusive dialogue of EU institutions, Member States, water operators, patients, healthcare systems and industry,Conduct new independent studies, as part of a necessary repair of the Directive, based on sound science, proportionality and real world healthcare economics, to assess the impact on the availability, accessibility and affordability of medicines,A relaunch of the Directive in a workable form that delivers clean water without jeopardising the availability, accessibility and affordability of medicines for patients across Europe.  Zentiva provides health and wellbeing for all generations, with focus on developing, producing, and delivering high-quality, affordable medicines to more than 100 million people in over 40 countries across Europe and beyond. Zentiva has four wholly-owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. Zentiva employs more than 5,400 unique talents, bonded together by a commitment to the people who depend on our medicines every day. Visit us at www.zentiva.com  About Zentiva Newsroom

Zentiva Demands EU‑Level Stop‑the‑Clock on the UWWTD to Protect Medicine Availability

2026-02-23-uwwtd

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Zentiva appeals EU court decision on Urban Wastewater Directive

Zentiva Demands EU‑Level Stop‑the‑Clock on the UWWTD to Protect Medicine Availability

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