Sandoz warns Europe is at heightened risk regarding antibiotic supply due to reliance on Asian imports, urging regulatory support for domestic production.
Unequal Competition with Asia
Europe is highly dependent on antibiotic production outside the continent, a structural issue that has grown over decades as production capabilities diminished. China and India now dominate the global supply chain, often with state support and industrial policies.
This dependence creates vulnerabilities from geopolitical tensions to disruptions in global supply chains, potentially limiting access to crucial therapies for patients. Antibiotics should be viewed as essential for Europe’s health security and systemic resilience.
The Need to Maintain European Production
The current market model, driven by price reductions in public procurement systems, erodes the profitability of antibiotic production in Europe. This makes domestic production increasingly unsustainable.
Incentives, long-term purchasing policies, and pricing mechanisms are needed to promote stable and sustainable production in Europe, prioritizing supply security and systemic resilience over solely the lowest price.
Pharmaceuticals Under Pressure from Sewage Directive
The new EU Sewage Directive, adopted November 27, 2024, aims to improve environmental quality and water resource protection, which the pharmaceutical sector supports.
However, the directive primarily targets municipal wastewater and introduces extended producer responsibility, shifting significant modernization costs – including fourth-stage purification – onto the pharmaceutical and cosmetic sectors.
Concerns arise from the financing mechanism and assumptions about pollution sources, with the pharmaceutical sector’s contribution potentially overstated and implementation costs underestimated. Analyses suggest production costs for essential medicines like amoxicillin and metformin could increase by hundreds of percent, potentially leading to market withdrawal and reduced access for patients.
Biologically Equivalent Medicines for Poland
Biologically equivalent medicines offer a key solution to growing healthcare challenges in Europe, including aging populations, chronic diseases, and budget constraints.
These medicines provide comparable efficacy and safety to reference products at significantly lower costs – often around 60% less – increasing patient access, enabling earlier treatment, and improving health outcomes.
Poland’s utilization of these therapies remains relatively low, around 3% compared to the EU average of 20%, but there are signs of increasing openness to change and development. The next decade promises significant opportunities as many biologicals lose patent protection.
Sandoz in Poland and Europe
Sandoz is a global leader in generic and biosimilar medicines, with two facilities in Poland – Stryków near Łódź and Warsaw – producing and packaging medicines exported to over 100 countries. In 2025, these facilities produced and packaged 27 billion tablets.
Sandoz also operates the last fully integrated, large-scale antibiotic production facility in the Western world, located in Kundl, Austria, aiming to ensure Europe’s autonomy in amoxicillin supply.
