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Zentiva's European Health Check Reveals Critical Issues in Generic Drug Sustainability

On December 18, 2024, Zentiva hosted a significant event, the "European Health Check," which shed light on pressing issues within the generic pharmaceutical industry. A live survey conducted during the event revealed that a staggering 77% of participants believe the current framework governing the generic drug industry is neither sustainable nor effective in ensuring the availability and accessibility of medicines for patients across the EU.

The findings presented a stark reality that emphasizes the urgent need for systemic reforms in the generic drug sector. As highlighted by Ines Windisch, Head of Communications, Corporate Affairs, and Sustainability at Zentiva, generics are crucial for Europe's healthcare system, as they make up 70% of medications in the region, including 90% of essential drugs. However, this fundamental sector is facing increasing pressures due to fragmented regulations, price caps, and bureaucratic challenges associated with the European Green Deal.

"Generics are the cornerstone of the European health system, but they are increasingly under pressure from various regulatory hurdles. It is essential that Europe remains competitive without compromising on the high standards of healthcare that our citizens expect," Windisch stated at the event.

Windisch further remarked on the importance of the proposed Critical Medicines Act, which aims to reform the regulatory environment and create incentives for manufacturing, ensuring that medications remain accessible and affordable for those who rely on them daily. "Our discussions should not be limited to theoretical understanding, but rather act as a catalyst for genuine and effective change," she urged.

During the discussions, high-level representatives from key EU institutions, the European Parliament, national government bodies, and Medicines for Europe shared insights on the challenges and opportunities facing the off-patent drug sector. A critical topic that emerged was the looming risk of medicine shortages. Though reporting and containment strategies are being implemented, the fragmented stocking policies in the larger EU member states could make smaller countries vulnerable, contradicting the EU's principle of solidarity.

The recent approval of a directive concerning the treatment of municipal wastewater also sparked concern. Adrian van den Hoven, Director General of Medicines for Europe, explained that the new directive imposes a fee on the pharmaceutical industry tied to the discharge of unused medications into wastewater systems. This is effectively a consumption tax on medicines, potentially leading to further drug shortages as production becomes financially unviable for generic manufacturers. Moreover, such a selective approach raises serious questions about fairness, as it places the burden solely on medicines and cosmetics.

In light of the discussions and the resounding support from industry voices and policymakers present at the event, Zentiva and the generic drug industry are calling on EU heads of state and government to adjust pricing in response to inflation pressures and to prioritize a harmonized stocking policy. They also demand the introduction of fair cost-sharing mechanisms that do not target only a few sectors.

Implementing these measures could fortify Europe's medicine supply chain, enhancing the accessibility and affordability of high-quality treatments for all EU patients. "Generics are more than affordable alternatives; they are lifelines for millions of people," Windisch emphasized, reiterating the necessity of ensuring the sustainability and availability of generics for future generations.

The event concluded with a strong message from Zentiva — securing a viable future for the generic drug industry is vital for safeguarding the health and well-being of European citizens. For those who missed the session, a complete recording of the European Health Check is available for viewing.

Zentiva stands as a pan-European platform dedicated to developing, manufacturing, and providing high-quality and affordable medicines to over 100 million people across Europe. With four manufacturing sites and a robust network of external partners, Zentiva assures supply security in key therapeutic areas, including cardiology, oncology, and respiratory diseases. The privately held company exhibits sustainable double-digit growth, with an ambitious five-year plan geared towards robust expansion throughout Europe.

For more information about Zentiva, please visit www.zentiva.com.