Zentiva Calls for a Pause on UWWTD Implementation to Safeguard Medicine Availability Across Europe
On February 23, 2026, Zentiva, a prominent European manufacturer known for its affordable high-quality medicines, addressed concerns regarding the Union's Urban Waste Water Treatment Directive (UWWTD). The company emphasized that the current form of this directive poses a significant threat to the reliable supply of essential medications across Europe. Despite the directive being adopted in 2025, which raised serious objections from 16 EU member states, Zentiva initiated legal actions to overturn it, with the goal of ensuring uninterrupted access to vital medications for patients who heavily rely on these treatments daily.
The recent ruling from the European Court clarified the legal status under EU law. The Court indicated that Zentiva and other producers of off-patent and generic medicines are not considered as entities directly affected by the directive, meaning they lack a direct legal pathway to challenge it in court. This ruling ignores the profound and tangible impact the directive has on the pharmaceutical sector, particularly in relation to the medications provided throughout Europe. Moreover, the Court did not evaluate the core issues at stake, such as the legality of the producer's extended liability system under the UWWTD nor whether the financial model is feasible, proportional, or safe for ensuring the continued availability of these vital medications.
Steffen Saltofte, CEO of Zentiva and chairman of Medicines for Europe, expressed concern about the implications that such a directive can have on medicine production. He noted that the UWWTD, though adopted and currently in the implementation phase, is based on assessments that have been scientifically debunked numerous times. The directive requires the pharmaceutical and cosmetics industries to cover at least 80% of the costs for treating wastewater to a fourth treatment level, a demand that he argues is unfeasible for non-patented drug sectors. The majority of drug prices in this sector are heavily regulated, with the daily dose of unprotected medications costing just a few cents. Saltofte emphasized that the industry would simply not be able to absorb such costs.
Should this directive be enforced in its current state, it will likely render the manufacturing of many essential medications economically unviable, adversely affecting patients across all EU member states by restricting access to affordable therapies and heightening the risk of drug shortages. Ultimately, the burden of these changes would fall on the patients, raising serious ethical concerns.
The Court's decision does little to resolve these long-standing issues, further underlining the urgent need for political and strategic corrections before full implementation leads to lasting damage. The generic drug sector, in particular, accounts for 70% of all medications dispensed, including 9 out of 10 critical medicines. If no further action is taken and the directive is transposed into national law across all 27 member states, it poses a high likelihood of leading to widespread shortages.
Saltofte reiterated that as a CEO based in Europe and a representative of the non-patented drug sector, he is not willing to passively observe these developments. He pledged to continue advocating for a collaborative solution that must involve all stakeholders—not in isolation, but collectively. This urgent issue necessitates that all stakeholders sit at the table to halt the directive's rollout, amend it at the EU level, and reintroduce it in a feasible format that ensures clean water without compromising the accessibility and affordability of healthcare for all individuals in Europe who depend on these medicines daily.
As the directive enters the stage of national implementation, there is an immediate need for political leadership and dialogue. Zentiva calls for a suspension of the current UWWTD implementation at the EU level to facilitate an inclusive dialogue involving EU institutions, member states, water supply system explorers, patients, healthcare systems, and industry representatives.
Additionally, there is a demand for new, independent studies to provide the necessary adjustments to the directive, built on sound scientific bases, proportionality principles, and the real economic conditions of healthcare. These studies would assess the directive’s impact on the availability and affordability of medications. The aim is to redraft the directive in a workable form that promises clean water without undermining the availability and affordability of medicines for patients across Europe.
Zentiva is committed to the health and wellbeing of all generations, focusing on the development, manufacturing, and supplying of high-quality medicines at affordable prices for over 100 million people in more than 40 countries in Europe and beyond. To ensure supply security, Zentiva operates four production facilities and has a wide network of external manufacturing partners, employing over 5,400 skilled staff who are dedicated to assisting those in need of medications daily. More information can be found at www.zentiva.com.
The recent ruling from the European Court clarified the legal status under EU law. The Court indicated that Zentiva and other producers of off-patent and generic medicines are not considered as entities directly affected by the directive, meaning they lack a direct legal pathway to challenge it in court. This ruling ignores the profound and tangible impact the directive has on the pharmaceutical sector, particularly in relation to the medications provided throughout Europe. Moreover, the Court did not evaluate the core issues at stake, such as the legality of the producer's extended liability system under the UWWTD nor whether the financial model is feasible, proportional, or safe for ensuring the continued availability of these vital medications.
Steffen Saltofte, CEO of Zentiva and chairman of Medicines for Europe, expressed concern about the implications that such a directive can have on medicine production. He noted that the UWWTD, though adopted and currently in the implementation phase, is based on assessments that have been scientifically debunked numerous times. The directive requires the pharmaceutical and cosmetics industries to cover at least 80% of the costs for treating wastewater to a fourth treatment level, a demand that he argues is unfeasible for non-patented drug sectors. The majority of drug prices in this sector are heavily regulated, with the daily dose of unprotected medications costing just a few cents. Saltofte emphasized that the industry would simply not be able to absorb such costs.
Should this directive be enforced in its current state, it will likely render the manufacturing of many essential medications economically unviable, adversely affecting patients across all EU member states by restricting access to affordable therapies and heightening the risk of drug shortages. Ultimately, the burden of these changes would fall on the patients, raising serious ethical concerns.
The Court's decision does little to resolve these long-standing issues, further underlining the urgent need for political and strategic corrections before full implementation leads to lasting damage. The generic drug sector, in particular, accounts for 70% of all medications dispensed, including 9 out of 10 critical medicines. If no further action is taken and the directive is transposed into national law across all 27 member states, it poses a high likelihood of leading to widespread shortages.
Saltofte reiterated that as a CEO based in Europe and a representative of the non-patented drug sector, he is not willing to passively observe these developments. He pledged to continue advocating for a collaborative solution that must involve all stakeholders—not in isolation, but collectively. This urgent issue necessitates that all stakeholders sit at the table to halt the directive's rollout, amend it at the EU level, and reintroduce it in a feasible format that ensures clean water without compromising the accessibility and affordability of healthcare for all individuals in Europe who depend on these medicines daily.
As the directive enters the stage of national implementation, there is an immediate need for political leadership and dialogue. Zentiva calls for a suspension of the current UWWTD implementation at the EU level to facilitate an inclusive dialogue involving EU institutions, member states, water supply system explorers, patients, healthcare systems, and industry representatives.
Additionally, there is a demand for new, independent studies to provide the necessary adjustments to the directive, built on sound scientific bases, proportionality principles, and the real economic conditions of healthcare. These studies would assess the directive’s impact on the availability and affordability of medications. The aim is to redraft the directive in a workable form that promises clean water without undermining the availability and affordability of medicines for patients across Europe.
Zentiva is committed to the health and wellbeing of all generations, focusing on the development, manufacturing, and supplying of high-quality medicines at affordable prices for over 100 million people in more than 40 countries in Europe and beyond. To ensure supply security, Zentiva operates four production facilities and has a wide network of external manufacturing partners, employing over 5,400 skilled staff who are dedicated to assisting those in need of medications daily. More information can be found at www.zentiva.com.
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