Geopolitical Tensions

Antibiotics: Europe at risk with fragile supplies and heavy dependence on Asia

A paper by Sandoz's Italian subsidiary draws the attention of institutions to the urgent need to strengthen European manufacturing autonomy

by Ernesto Diffidenti

Variety of medicines and drugs.Medicine and healthcare concept. mitsyko1971 - stock.adobe.com

3' min read

Translated by AI
Versione italiana

3' min read

Translated by AI
Versione italiana

In a global context marked by growing geopolitical tensions and increasingly fierce industrial competition, Europe has a significant criticality in the antibiotics sector, linked to a strong dependence on non-European supply chains, with a level of exposure that can compromise therapeutic continuity and the ability to respond in emergency situations.

Indeed, 60-80% of Europe's supply of active ingredients comes from Asia, while 80-90% of global antibiotic production is concentrated in China. A disruption in supply, is the message that emerges from a paper by the Italian subsidiary of Sandoz, the Swiss multinational leader in patent-expired drugs, equivalents and biosimilars, could have immediate effects on the industry's operational capacity and the resilience of European healthcare systems.

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A national security issue

"Talking about antibiotics today means addressing a national security issue," emphasises Francesca Romana Ramundo, CEO of Sandoz spa- . They are life-saving drugs, an essential prerequisite for modern medicine. Their availability is a prerequisite for the operability of the hospital system, for the readiness to respond to emergencies, and for the structural resilience of the health service. In this context, Europe and Italia in particular can no longer afford a structural dependence on long and vulnerable supply chains'.

In this perspective, the document 'European Antibiotic Resilience as a National Security Priority' outlines a vision in which Italia can significantly contribute to the definition of a European strategy on antibiotic safety, addressing in a structured way the vulnerabilities of the supply chain, strengthening domestic production capacity and, at the same time, protecting strategic industrial infrastructures.

About the institutions

The document, emphasises Ramundo, has already contributed to initiating 'a fruitful discussion' with Italy's main institutional interlocutors, starting with the Department for European Affairs of the Presidency of the Council, the Ministries of Foreign Affairs and Enterprise and Made in Italy, as well as the components of the Chamber of Deputies and the Senate, in addition to the main representatives of the sector on the ground, such as pharmacists and healthcare logistics experts.

"Sandoz is today the only remaining producer in the European Union with an integrated industrial capacity," adds Ramundo. "This is a strategic competence that can make a real contribution to strengthening the security and continuity of antibiotic supply in Europe. Ultimately, securing the European antibiotic supply chain means protecting and safeguarding what matters most, namely the ability to cure, today and tomorrow'.

The factory in Kundl producing penicillins

The Sandoz plant in Kundl, Austria, which has been in operation for 80 years, is one of the last fully integrated sites in Europe for the production of penicillins, from fermentation to finished product, with a capacity of around 4,400 tonnes of active ingredients and more than 240 million packs per year, shipped to more than 100 countries. In recent years, Sandoz has supported and innovated this asset with more than €200 million of investment, including around €150 million in the production of active ingredients and €50 million in the upgrading of finished pharmaceutical forms, with a 20% increase in capacity.

"However," Ramundo explains, "Kundl is now operating in an increasingly challenging context, characterised by rising production costs and increasing global competitive pressure, in the face of substantially unchanged antibiotic prices". Hence the industry's call for Europe to adopt 'a regulatory and market framework that fully recognises their value, integrating resilience and safety criteria and strengthening European production autonomy in one of the most critical segments for public health'.

Revision of the Waste Water Directive

An important first step in this direction would be a course correction on the Waste Water Directive, which, according to Sandoz, 'places an enormous and disproportionate burden on the pharmaceutical sector, particularly in the off-patent segment characterised by high volumes and low margins'. A hefty bill that could result in shortages of essential medicines. "That is why," Ramundo concludes, "it is necessary to arrive at decisions implementing the directive only with solid data and with an effective and fair burden-sharing: the green transition must be an investment for the country, not a risk factor for access to care.

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