REQUIREMENTS OF THE SCIENTIFIC REPORTER OF THE DRUG.
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.
With a view to scientific evolution, the law also provides that "the Minister of Health may, by decree, recognize as suitable, for the purposes of this article, other university-level diplomas.”
The standard does, however, salve "the situations regularly in place on the date of entry into force of this decree”.
This 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 education diploma or other degree not recognized as suitable.
Given, however, the important role recognized to scientific information with this law, the legislator requires that pharmaceutical companies impart to the informant "adequate training, so as to be in possession of sufficient scientific knowledge to provide accurate and as complete information on the medicines presented.”
The qualification of the scientific representative must, in fact, be such as to allow him to communicate effectively with the healthcare professional to whom he represents the drug, because the representatives "must report to the scientific service pursuant to art. 14, on which all the information on the side effects of the drugs depend, attaching, where possible, a copy of the reporting forms used by the doctor pursuant to art. 1 of the decree of the President of the Republic 25 January 1991, n. 93”.
The word “must” leaves no room for any interpretation.
This was followed by various ministerial decrees, which recognized other qualifications as suitable for the exercise of scientific information, until the EEC intervened again with new directives concerning medicinal products for human use and the code of ethics (2001/83/EEC and subsequent) and the 2003 directive /04/EEC, to which Italy adapts with delay with the 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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