The illustrious lawyers Lorenzo Maratea and Maurizio Campagna reply to my answer, with a new article in Quotidiano Sanità entitled "TheScientific drug rep. Why it is important to 'hybridize' the figure“.
In their exposition they state that Dr. Mazzarella does not take into account three profiles of the ISF. First they mention theart. 112 of Legislative Decree 219/06, but the cited article concerns homeopathic products that have nothing to do with the subject matter. Probably, due to an oversight, they refer to theart. 113 which concerns the definition of advertising of medicinal products or much more likely, due to a typing error in theart. 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.
They also claim that my position "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“.
The hybrid ISF “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“.
Now it is true that the art. 122 speaks of work, but not without any qualification as they assert, speaks of work of Scientific Representative of the drug that must be employed by the scientific service of the pharmaceutical company which must be independent from the Marketing Department (Articles 122 and 126). That's exactly what the law says! Once again the illustrious lawyers missed this detail.
They speak in the second point of Cassation (?), of a sentence of a Florence Court of 1985, when there was not even Legislative Decree 541, and of a Milanese court of 2015, forgetting to mention the Cassation with the sentence 15 September 2014 n. 19394 where it is stated verbatim that "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“. No mention of the Regional Regulations which effectively prevent the commercial activity of the ISFs
Third point: the practice. Which will also have value where there is no law of substance, but if there is a law it must be "according to the law", not against law Practices do not constitute a source of rights and obligations. If the practice is to steal from state coffers, it is not said that it is admissible because the "mariuolo" got away with it.
Very weak arguments that do not respond to our notes. In essence they claim that my position is in denial of the existence of the ISF problem. We do not deny that the ISF problem exists, on the contrary we do everything to highlight it. Only that the aforementioned problem is not what they say and above all it is not solved as they say.
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
Health newspaper - 16 September 2019
