REQUISITI DELL’INFORMATORE SCIENTIFICO DEL FARMACO.
The ISF profession has undergone profound changes over the last 30 years.
Following Directive 92/28/EEC concerning the advertising of medicinal products for human use, Legislative Decree No. 541 of 30.12.1992 was issued, which entered into force in January of the following year.
Thus, the role of scientific information in Italy is institutionalized and the informant is entrusted with the delicate task of publicizing to the "doctor" the characteristics of the drug he represents, and which the pharmaceutical company he depends on intends to commercialize.
It is now clear therefore that the scientific rep is the only intermediary interlocutor between the manufacturing company and the health care provider.
The law requires the possession of a degree in medicine and surgery, biological sciences, organic or biological chemistry, pharmacy, chemistry and pharmaceutical technology.
In un’ottica di evoluzione scientifica, la legge prevede anche che “il Ministro della sanità può, con decreto, riconoscere come idonei, ai fini del presente articolo, altri diplomi di laurea o altri diplomi di livello universitario.”
La norma fa, tuttavia, salve “the situations regularly in place on the date of entry into force of this decree”.
This is because it is a general principle of our legal system that the laws can only provide for the future and cannot affect acquired rights, so that an informant, who practiced before 1993, can continue in the exercise of this activity, even if in possession of only a secondary school diploma or other unrecognized suitable degree.
Considerato, però, l’importante ruolo riconosciuto all’informazione scientifica con tale legge, il legislatore impone che le imprese farmaceutiche impartiscano all’informatore “una formazione adeguata, così da risultare in possesso di sufficienti conoscenze scientifiche per fornire informazioni precise e quanto più complete sui medicinali presentati.”
La qualificazione dell’informatore scientifico deve essere, infatti, tale da consentirgli di interloquire efficacemente con il sanitario a cui rappresenta il farmaco, perché gli informatori “devono riferire al servizio scientifico di cui all’art. 14, dal quale dipendono, tutte le informazioni sugli effetti secondari dei farmaci, allegando, ove possibile, copia delle schede di segnalazione utilizzate dal medico ai sensi dell’art. 1 del decreto del Presidente della Repubblica 25 gennaio 1991, n. 93”.
The word “must” leaves no room for any interpretation.
Various ministerial decrees followed, which recognized other qualifications as suitable for the exercise of scientific information, until the EEC intervened again with new directives concerning medicines for human use and the code of ethics (2001/83/EEC and subsequent) and directive 2003/04/EEC, to which Italy adapted with delay with Legislative Decree 24.04.2006 n.219.
Article 122 reformulates the content of the activity of scientific representatives and adjusts the necessary requirements.
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