ISF extension. Why it is important to 'hybridize' the figure. The reply and our rejoinder

Gli illustri avvocati Lorenzo Maratea e Maurizio Campagna replicano alla mia risposta,con un nuovo articolo si Quotidiano Sanità dal titolo “IScientific drug rep. Why it is important to 'hybridize' the figure“.

Nella loro esposizione affermano che il Dr. Mazzarella non tenga conto di tre profili dell’ISF. Per primo citano l’art. 112 del D.Lgs. 219/06, ma l’articolo citato riguarda i prodotti omeopatici che non centrano nulla con il tema trattato. Probabilmente, per una svista, si riferiscono all’art. 113 che riguarda la definizione di  pubblicità dei medicinali o molto più probabilmente, per un errore di battitura all’art. 122 as, they assert, we speak of "work" activities of the ISFs, without any further qualification.

Secondly, they cite some court rulings, the position taken by the Supreme Court and two rulings by courts of merit, one in 1985 and one by the Court of Milan, 30 December 2015 which ruled on the independence of the whistleblower report.

The third quotation concerns the contractual practice in favor of an ISF-agent and an ISF-procurer.

Affermano inoltre che la mia posizione “it would be acceptable if the law clearly established the necessary subordinate nature of the ISF, if the contractual practice developed by the pharmaceutical companies were univocal and, lastly, if the jurisprudence were consolidated. Unfortunately, none of the three conditions is objectively present. From there a proposal, ours, which, like all proposals, does not aim to be the bearer of truth, but which certainly does not discount the limit of any mandatory rule“.

L’ISF ibrido “it would probably have the merit of better regulating the activity which in many cases is actually carried out by the ISFs by better reconciling the scientific vocation with the commercial aspect that is proper to propaganda, with positive effects also in terms of the certainty of the contributory obligation“.

Ora è vero che l’art. 122 parla di lavoro, ma non senza alcuna qualificazione come asseriscono, parla di work of Scientific Representative of the drug that must be employed by the scientific service dell’azienda farmaceutica il quale deve essere indipendente dalla Direzione Marketing (Articles 122 and 126). That's exactly what the law says! Once again the illustrious lawyers missed this detail.

Parlano al secondo punto di Cassazione (?), di una sentenza di un Tribunale di Firenze del 1985, quando non c’era neanche il D.Lgs. 541, e di un tribunale milanese del 2015, dimenticando di citare la Cassazione con la sentence 15 September 2014 n. 19394 in cui si dice testualmente che “the relationship of the person who mainly carries out the activity of medical-scientific informant rather than that of commercial agent must be traced back to the canons of subordinate work“. Nessun accenno ai Regolamenti Regionali che impediscono di fatto proprio l’attività commerciale degli ISF

Terzo punto: la prassi. Che avrà anche valore dove non c’è una legge di merito, ma se c’è una legge deve essere “secondo legge”, non against law Le prassi non costituiscono fonte di diritti e obblighi.  Se la prassi è rubare nelle casse dello Stato, non è detto che sia ammissibile perché il “mariuolo” l’ha fatta franca.

Argomenti molto deboli che non rispondono ai nostri appunti. In sostanza affermano che la mia posizione è negatoria dell’esistenza del problema ISF. Noi non neghiamo affatto che esista il problema ISF, anzi facciamo di tutto per evidenziarlo. Solo che il suddetto problema non è quello che dicono loro e soprattutto non si risolve come dicono loro.

The "ISF problem" is linked to an ethical question, questioned by the contractual aspect. Pharmaceutical companies produce and market a very delicate product, the drug, aimed at the citizen who uses it in a particular moment of his life, i.e. when he is not in health.

With Legislative Decree 219/2006, the legislator wanted to make the scientific representative responsible by recognizing in him the delicate role of linking pharmaceutical research and the doctor who will be able to choose the most useful drug for his patient with greater knowledge of the facts. Ultimately, the Scientific Representative helps to enforce the citizen's right to health enshrined in the ART. 32 of the Constitution.

If the ISF is managed commercially, and therefore paid as a percentage of the boxes sold, it has more interest in making sales volumes than in providing the doctor with correct information both on the beneficial effects and on the side effects of the relevant drug. Another very important aspect, and always underestimated, is pharmacovigilance. The ISF has the task, by law and together with the doctor, of collecting reports of adverse events of which it receives news both from the doctor and, accidentally, in the waiting rooms from patients. If the interest of this worker is to sell, why should he "risk" of casting a shadow on the validity of the product that allows him to support a family?

Bottom line, in our humble opinion, hybrid ISF not only makes no sense, but runs the risk of making it harmful to the community. While, again in our opinion, greater compliance with current legislation, assuming it is interpreted correctly, would allow the ISF to increase transparency in the health sector, obtaining another positive effect which is savings, as it would favor prescriptive appropriateness much sought after by health administrators.

However, we are pleased that today there is greater attention to the theme of "Scientific Information". It would have been more welcome years ago when it was decided, due to contingent needs, to include this professional figure in the CCNL in the field of marketing, creating the "practice" mentioned by the distinguished lawyers. But it's never too late to repair the damage done.

Foggia, 09/13/2019

Dr. Antonio Mazzarella

Quotidiano sanità – 16 settembre 2019