L'industria farmaceutica italiana, 1945-1978. Una storia economica

In the Fifties and Sixties, the Italian pharmaceutical industry experienced a rapid growth, driven by a product- line renewal, increased sales and the expansion of the Welfare State. Many commentators of the time, however, pointed out that many producers were just craftsmen with no industrial organisation or projection. In the first decades after the Second-World War, in Italy policy makers designed a market with low barriers to entry, in which pharmaceutical companies could survive even without a real innovative activity. Before 1978, in fact, the Italian legal system expressly excluded drug patenting. In such a context just a small minority of companies had well-equipped research laboratories, while the majority of them tended to imitate and copy their competitors' products. Consequently, the Italian pharmaceutical sector showed the ability to develop process innovation rather than product innovation. In the long run, however, a rapidly grown market with low barriers to entry led to some issues. Italian pharmaceutical companies were generally much smaller and less internationalized than their competitors abroad to the extent that it was very difficult to defend their position on the domestic market when big international competitors expanded into Italian market. From this scenario, a dramatic change took place in the early Sixties. Neonatal malformations caused by Thalidomide contributed to change pharmaceutical legislation in many countries, including Great Britain and the United States. Italian companies initially avoided a tightening of the rules. A few months later, however, a journalist investigation revealed that it is was also possible to circumvent the existing rules on new drug testing. As a result, public authorities enhanced controls and began to gradually tighten the requirements to operate in this sector. More rigorous criteria for new-drug registration and for quality control of production process generated a radical change in the pharmaceutical sector, with a significant increase of the number of laboratories and specialized libraries. The companies unable to comply with the new requirements gradually left the market. Those which stayed in the market were equipped with laboratories for product quality control and research facilities. Italian pharmaceutical companies started to raise their investment in new-drug research.

Come è cambiata la struttura dell’industria farmaceutica italiana nel secondo dopoguerra? Quali elementi hanno reso difficile colmare il ritardo accumulato nei confronti dei principali competitori internazionali? E quali fattori, invece, hanno consentito di avviare un processo di progressiva qualificazione della produzione? L’interazione tra i cambiamenti in corso a livello internazionale (la cosiddetta rivoluzione farmacologica), la forte espansione del mercato farmaceutico italiano e la regolamentazione del settore da parte dell’attore pubblico contribuiscono a determinare lo scenario competitivo all’interno del quale si muovono le imprese e, in ultima misura, le stesse caratteristiche di fondo del comparto farmaceutico. Da un lato l’intreccio di interessi economici spesso contrastanti, di motivazioni etiche e di pressioni politiche complicano la modifica delle «regole del gioco», anche quando esse sono evidentemente inadatte a governare un settore che ha fatto il salto dalla dimensione artigianale a quella industriale. Dall’altro, tuttavia, sembrano attivarsi processi di trasformazione che fanno leva sulle prassi e le procedure adottate da ministero ed enti mutualistici: una «supplenza legislativa» che, pur con tutti i suoi limiti, cerca di indirizzare lo sviluppo del settore, contemperando esigenze industriali e obiettivi sociali.