di Enrica Giorgetti*
La tutela della proprietà intellettuale e in particolare del brevetto è una priorità fondamentale dell’industria farmaceutica che svolge attività di ricerca e sviluppo. Una tutela che ha permesso di raggiungere risultati importantissimi per la salute dei cittadini, migliorando l’aspettativa e la qualità di vita.
Solo a partire dal 1978 in Italia – con notevole ritardo rispetto agli altri Paesi occidentali – e grazie alla decisione della Corte Costituzionale è stato possibile introdurre il brevetto.
Per le aziende farmaceutiche la protezione brevettuale costituisce un elemento essenziale per il progresso scientifico, favorisce il miglior accesso del paziente alle cure e costituisce attrazione degli investimenti in Italia ed Europa.
Mettere a disposizione un nuovo farmaco richiede l’impegno di molte persone, idee, anni e investimenti ingenti. Sono necessari infatti circa 15 anni di studi e sperimentazioni e solo una sostanza ogni 5-10 mila supera con successo i test necessari per diventare un medicinale. E solo 2 farmaci su 10 consentono di ammortizzare i costi di ricerca e sviluppo. Con investimenti che possono superare 1 miliardo di euro, arrivando a 2,6 miliardi se si aggiunge il costo del capitale investito nel progetto di ricerca.
Nel prossimo quinquennio le imprese farmaceutiche a livello globale investiranno nella R&S farmaceutica oltre 1.600 miliardi di euro, a fronte di una pipeline in continua crescita che oggi conta più di 21 mila farmaci in sviluppo.
Oggi il brevetto è disciplinato dal Codice della proprietà industriale ed è oggetto di disciplina e armonizzazione da parte della legislazione europea, che ha affiancato alla tutela brevettuale l’istituto del Certificato di Protezione Complementare (SPC).
La durata del brevetto, pari a 20 anni, nella farmaceutica non coincide con l’esclusiva riconosciuta agli altri prodotti. La durata effettiva viene compressa dai tempi necessari alla registrazione – mediamente 10, 12 anni – che sono solo parzialmente recuperati attraverso il meccanismo di protezione complementare che permette così il recupero del tempo intercorso tra la data della domanda di brevetto e l’autorizzazione all’immissione in commercio.
La Commissione Europea recentemente ha proposto l’introduzione di un SPC unitario efficace in tutti i 27 Paesi dell’Unione europea.
Sono previste poi altre garanzie che assicurano la protezione dei dati necessari alla registrazione dei farmaci, la cosiddetta data protection e market exclusivity. Istituti finalizzati al giusto equilibrio tra la tutela della proprietà intellettuale e l’accesso al mercato da parte dei produttori di farmaci generici.
La proposta di modifica della legislazione farmaceutica europea desta però notevoli preoccupazioni perché prevede una significativa riduzione dei meccanismi di tutela brevettuale fino a oggi adottati.
Un passo indietro rispetto ad altri Paesi come gli Stati Uniti che hanno adottato politiche fortemente incentivanti negli ultimi 20 anni, mentre l’Europa nello stesso periodo ha perso un quarto degli investimenti in ricerca.
Se l’Europa dovesse continuare nella sua strada ideologica e antindustriale l’impatto di queste misure avrebbe conseguenze negative sulla ricerca e gli investimenti in Italia e in ambito Ue.
Un grido di allarme è stato lanciato proprio dal Governo italiano che con coraggio e pubblicamente ha preso una decisa posizione a favore della proprietà intellettuale e dell’innovazione.
In gioco, c’è un’industria che rappresenta un patrimonio per la salute, la crescita economica, l’innovazione e la stessa sicurezza nazionale. Senza dimenticare che la nostra industria parla al femminile, con il 44% del totale degli addetti che è donna (la media è sotto il 30%) e la quota è identica per dirigenti e quadri. Il 47% fra gli under 35; il 53% nella ricerca.
*Direttore Generale Farmindustria
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