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Zentiva Calls for Suspension of UWWTD

In a bold move, Zentiva, a prominent European manufacturer of affordable, high-quality medications, is calling for the European Union (EU) to temporarily suspend the Urban Waste Water Treatment Directive (UWWTD). This request comes on the heels of a significant ruling by the General Court of the European Union, which suggests that the current form of the UWWTD poses a considerable risk to the availability of essential medicines in Europe.

The controversy stems from the directive's directive, which has raised substantial concerns among 16 EU member states. Despite these worries, the directive was adopted, prompting Zentiva to file a lawsuit in 2025 aimed at overturning its provisions. The primary goal of this legal action was to safeguard a reliable supply of essential medicines for patients who rely on these vital treatments daily.

The court's decision sheds light on how EU law interprets the legitimacy of claims. It concluded that Zentiva and other generic and off-patent drug manufacturers do not possess a direct legal avenue to challenge the directive individually. This lack of recourse is troubling, especially considering the true impact this directive will have on the pharmaceutical sector and the medicines provided across Europe.

It is noteworthy that while the court ruled, it did not address the underlying issues at stake, such as whether the extended producer responsibility (EPR) system outlined in the UWWTD is compatible with EU law or if its cost model is feasible or safe for ensuring continued medicine supplies.

Steffen Saltofte, the CEO of Zentiva and the current president of Medicines for Europe, expressed deep concerns regarding the implications of the UWWTD. He stated, "The UWWTD has been passed and is currently being implemented based on assessments that have been scientifically refuted multiple times. Nonetheless, it mandates the pharmaceutical and cosmetics industries to cover at least 80% of the costs associated with wastewater treatment in its fourth phase. From the outset, we recognized that this would be unfeasible for the off-patent drug industry, as our prices are heavily regulated, and a daily dose of a generic medication costs mere cents. We simply cannot absorb these costs."

If implemented without adjustments, the directive could render the production of numerous essential drugs economically unviable. Such a scenario would directly impact patients in all EU member states, leading to decreased access to affordable treatments and an increased risk of drug shortages. Ultimately, the financial burden would fall on the patients who depend on these medications.

The court's ruling does not resolve the long-standing issues, leaving the core questions about the directive's implications unanswered. This further emphasizes the need for political intervention and regulatory changes before full-scale implementation could lead to adverse consequences.

The generic medicine industry accounts for approximately 70% of all dispensed drugs and 90% of essential medications. If no further actions are taken and the directive is enacted into the national legislations of the 27 EU member countries in its current format, a massive shortage of essential medicines is likely to occur.

Saltofte further asserted, "As a European-based CEO and president of Medicines for Europe, representing the off-patent medicine industry, I refuse to sit idly by while this unfolds. We will continue to advocate for a solution that we must develop collaboratively, not in isolation or without the industry’s participation. This issue necessitates all stakeholders to come together to halt the current application, amend it at the EU level, and re-launch it in a viable manner that ensures clean drinking water without jeopardizing the availability, accessibility, and affordability of healthcare for those in Europe reliant on our medications."

What Needs to Happen Next

As the UWWTD has already been adopted and is moving towards national implementation, the call for political leadership and dialogue has never been more urgent. Zentiva is advocating for:

• - A pause in the current enactment of the EU drinking water directive to allow for inclusive dialogue among EU institutions, member states, water operators, patients, health systems, and the pharmaceutical industry.
• - Conducting new independent studies, pivotal for a necessary review of the directive, grounded on robust scientific data, proportionality, and actual healthcare economics, to assess the impact on drug availability, accessibility, and affordability.
• - Relaunching the directive in a form that guarantees clean water supply while also ensuring the availability, accessibility, and affordability of medications for patients throughout Europe.

About Zentiva

Zentiva is committed to promoting health and well-being across all generations by focusing on the development, manufacture, and supply of affordable, high-quality medications to over 100 million people in more than 40 countries, both in and out of Europe. The company operates four owned manufacturing plants and maintains a robust network of external manufacturing partners to ensure supply security. With a dedicated workforce of over 5,400 unique talents, Zentiva is united by their mission to support individuals who rely on their medications daily. For more information, visit www.zentiva.com.