[REVISION HISTORY]

Italian pharmaceutical spending and supply chain stability

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2026-09-29 18:23 UTC → 2026-09-29 20:38 UTC · added ~~removed~~

The Italian Medicines Agency (AIFA) has released reports detailing fiscal and structural challenges within the national pharmaceutical sector. Earlier monitoring from early 2026 revealed a significant spending deficit in direct pharmaceutical purchases, which exceeded its budget ceiling by 950.6 million euros. AIFA attributed this primarily to spending on non-innovative drugs, even as the pharmacy-dispensed medicine channel maintained a surplus. By late September 2026, AIFA’s focus expanded to address medicine availability and supply chain vulnerabilities. While the agency noted that current shortages do not constitute a “widespread health emergency”—with fewer than 2,600 medicines listed as scarce and ~~many~~ nearly 2,000 having available therapeutic equivalents—it highlighted strategic risks in the global supply chain. Specifically, the report pointed to a heavy reliance on Asia for 60% to 80% of active pharmaceutical ingredients (APIs). A September 28 dossier clarified that of the nearly 2,000 medicines with available equivalents, AIFA utilizes import authorizations from abroad to ensure continuity of care for the remaining 600 scarce items. The agency noted (APIs), noting that China and India control approximately two-thirds of global ~~API~~ production capacity. This concentration, alongside geopolitical tensions, rising energy costs, and logistics disruptions in regions such as the Red Sea, has increased the risk of supply instability. Furthermore, the agency identified potential market disincentives, suggesting that international pricing mechanisms, such as Economic pressures also persist within the US-driven Most Favored Nation mechanism, might cause manufacturers to delay launching innovative treatments in Italy to avoid impacting prices in larger markets. Additionally, industry reports indicate that while sector. While the Italian generic and biosimilar ~~sector remains robust with~~ market reached 6.8 billion euros in revenue, profitability ~~is under pressure from rising production and service costs. The Egualia Observatory noted a 0.3 percentage point drop in profitability~~ fell to 2.8% in ~~2025, following~~ 2025 due to a 32.1% increase in production costs between 2020 and 2024. To bolster healthcare sustainability, officials are emphasizing the role of generic and biosimilar medicines, which are projected to save the public healthcare system 1.2 billion euros between 2026 and 2028. However, experts note that Italy currently lags behind other European nations in the utilization of these cost-effective options, prompting calls for improved professional training and public information to address quality stigmas.

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