#Zentiva #Czech Republic #Prague #EU Directive #Medicines

Zentiva's Urgent Call to Suspend EU Wastewater Directive

Introduction

Zentiva, a leading European manufacturer of high-quality affordable medicines, has stepped forward, expressing grave concerns regarding the EU Directive on wastewater treatment. In light of the potential adverse impacts on drug availability, Zentiva has publicly called for the suspension of implementation of this directive across Europe.

Background of the Directive

The EU’s current wastewater directive aims to ensure that municipal wastewater treatment processes meet specific environmental standards. However, Zentiva argues that the implementation of this directive, particularly its obligations for pharmaceutical and cosmetic industries, poses a significant threat to the supply of essential medications across Europe.

In 2025, despite serious objections raised by 16 EU member states, Zentiva initiated legal action to annul this directive. The company highlighted that the framework fails to consider the critical realities faced by manufacturers of generics and off-patent medicines. These manufacturers often operate under strict price regulations, which, combined with the financial burden placed by the new directive, threatens the economic viability of producing low-cost medications.

The Court's Ruling

Recently, the General Court of the European Union ruled against Zentiva, stating that the company did not possess individual standing to challenge the directive. This ruling focused more on procedural aspects rather than the core implications of the directive on drug availability, thereby aggravating health stakeholders’ concerns.

Zentiva's CEO, Steffen Saltofte, emphasized that the court's decision does not resolve the fundamental issues at hand. He believes that imposing significant costs related to wastewater treatment on the industry is unrealistic, especially for generic medications that are priced at mere cents per daily dose. The potential result of the current directive’s implementation without modification could lead to dire shortages of basic medicines, impacting patients who depend on these drugs daily.

Warnings from the Industry

Zentiva's position highlights an urgent call for political and strategic intervention. As Saltofte pointed out, nearly 70% of all medicines dispensed in Europe are generics, and most critical medications come from this sector. He stated, "If the directive is adopted as is, we are likely to see a massive shortfall in essential drugs across all EU member states."

The Need for Inclusive Dialogue

Recognizing the urgency of the situation, Zentiva insists on initiating an inclusive dialogue among EU institutions, member states, water utility operators, healthcare systems, and the pharmaceutical industry itself. The company calls for:
1. A suspension of the current application of the wastewater directive, enabling collaborative communication amongst all stakeholders.
2. Independent studies to reassess the directive, grounded in reliable scientific data, to evaluate its actual impact on the accessibility and affordability of medicines.
3. A revision of the directive into a functional framework that maintains clean water standards without jeopardizing medication supply.

Conclusion

As the directive enters the implementation phase at the national level, Zentiva asserts that failing to address these pressing issues could have irrevocable consequences for public health in Europe. The company remains steadfast in its commitment to collaborate with all involved parties to rectify the directive before it inflicts serious harm on the availability of essential medicines.

Zentiva is dedicated to ensuring health and wellness for future generations. With a mission focused on developing, manufacturing, and delivering affordable and high-quality medicines to millions of people across Europe and beyond, the necessity for immediate action and rectification remains clearer than ever.

For more information, visit www.zentiva.com.