Which amnesty for non-graduated ISF? The one from 1992 or the one from 2006?

Despite not having a Register or Order, the profession of the Scientific Drug Representative (ISF) is one of the most regulated professions that exists, in fact it must comply with European Directives, Italian State Laws, Guidelines of the Conference of Regions and Provinces Autonomous, Regional Regulations.

Let's do some history on the reason for this excess of rules and regulations.

With the pharmaceutical industry also came the need to make pharmaceutical products known to prescribers in general and doctors in particular. Thus was born the figure of the propagandist (as he was called then) who went to hospitals and surgeries to make medicines known on behalf of the industry he represented.

But as the industry grew with its growing portfolio of products, the potential ethical conflict of making money selling health-related products became increasingly clear. George Merck expressed himself on the subject in 1950: “We should never forget that medicine is for people. It's not for profits. Profits come as a result, and if we remember this lesson, they won't stop being there. The better we remember it, the greater the profits”. This industry involving the "public" required oversight, and drug regulations required by governments on both sides of the Atlantic increased.

The Cassation has also declared in a series of judgments that: “The consumption of medicines is not regulated by the criterion of pleasure, but by that of utility, mediated by the medical profession, so that doctors are the recipients of a specific form of advertising which aims not at abstractly advertising the product by praising its virtues or pleasantness view of the package, but to inform them of the nature and pharmaceutical uses of the product, in which cases it is indicated, in which it is not and in which it is even harmful (see Cass. n. 25053 of 2006; see also v. Cass. n. 8844 of 2014; Cass. n. 2349 of 2013; Cass. n. 5494 of 2013)"

Nasceva la necessità di porre delle regole con lo scopo di evitare il più possibile i conflitti di interesse, ponendo l’informazione scientifica alle dipendenza di un “servizio scientifico” indipendente dal marketing e renderla qualificata da un titolo di laurea adeguato per gli informatori scientifici del farmaco.

On August 5, 1978 the law was promulgated Law n.484 che pone le basi per una regolamentazione sull’informazione scientifica e la pubblicità dei farmaci disciplinata poi nella successiva regolamentazione che è avvenuta con la law n.833 of 1978, which establishes the SSN, which in art. 29 says that a State law must be implemented “la regulation of the scientific information service on medicines and of the activity of scientific representatives”, which was followed by various implementing ministerial decrees.

A few years later, the European Commission elaborated a series of Directives which concerned the homogenization of the legal provisions, concerning scientific information, to be applied in the individual countries making up the Community (Directive n. 92/28 EEC, transposed in Italy with the Legislative Decree 30 December 1992, no. 541, ha delineato la figura professionale dell’ISF). Il D.Lgs. 541/92 disponeva che l’ISF doveva essere in possesso di una delle lauree che lo stesso D.Lgs. elencava. Il Decreto disponeva anche una sanatoria per gli ISF non laureati al momento della pubblicazione del Decreto sulla Gazzetta Ufficiale.

Arrivando all’oggi, in seguito alle Direttive europee 2001/83/CE e 2003/94/CE, è entrato in vigore il Decreto Legislativo 24 aprile 2006, n. 219 che all’article 122 ("Requirements and activities of scientific representatives"), reformulated the content of the activity of scientific representatives, in particular in paragraph 2 it says: "Without prejudice to the situations regularly in place on the date of entry into force of this decree, scientific representatives must be in possession of a university degree…” and lists the degrees suitable for the activity. Legislative Decree 219/06 in art. 158 repeals the previous Legislative Decree 541/92.

The question we are frequently asked is: which amnesty should be considered, that of 1992 or that of 2006?

Some maintain that in 2006 there should have been nothing to remedy since the anomalous situations had already been remedied by the 1992 Decree. Others maintain that the 1992 Decree was repealed, therefore the 2006 Decree, which starts with a new amnesty, applies.

The answer is given to us by AIFA, the drug regulatory body.

Come noto “entro il mese di gennaio di ogni anno, ciascuna impresa farmaceutica deve comunicare all’AIFA l’elenco degli informatori scientifici impiegati nel corso dell’anno precedente, con l’indicazione del titolo di studio e della tipologia di contratto di lavoro con l’azienda farmaceutica“, ecc..

L’AIFA ha predisposto per le aziende una scheda preformattata per gli ISF da compilare dove alla voce “degree” si apre un menu con delle risposte già inserite da spuntare da parte della stessa azienda: per quanto riguarda la sanatoria la casella da spuntare è “NO degree art. 122, paragraph 2 (amnesty ope legis)“. È evidente che la stessa AIFA fa riferimento al D.Lgs. 219/06 che fa testo. Altrettanto evidente è che chi ha usufruito della sanatoria del 1992 continuerà as essere sanato.

Ovviamente poi sta all’ISF dimostrare che lavorava con un’industria farmaceutica con farmaci da prescrizione a una data antecedente il 2006.

Altrettanto ovviamente le norme regolatorie riguardano “i medicinali che possono essere forniti soltanto dietro presentazione di ricetta medica o che contengono sostanze psicotrope o stupefacenti” (art. 115, Legislative Decree 219/06)

Anyone who has parapharmaceuticals, supplements, nutraceuticals, dermocosmetics, devices, milk for babies, etc., has no legal constraints for which therefore no specific title is required.