There are companies that require the ISF to visit pharmacies in order to gather information about their drugs and who prescribes them and to collect orders.
Is it a lawful practice?
To answer, we need to refer to the provisions of the law. First of all to Legislative Decree 219/06 and to art. 121, paragraph 1, says that "Advertising to pharmacists of medicines that can be sold on presentation of a medical prescription is limited to the information contained in the summary of the characteristics of the medicine [RCP]. The limitation does not apply to hospital pharmacists”. This statement already seems very clear to us.
Furthermore, the art. 122 requires that "Gli informatori scientifici devono riferire al servizio scientifico di cui all’articolo 126, dal quale essi dipendono” and in art. 126 it is specified that “il Servizio scientifico deve essere indipendente dal Servizio marketing dell’impresa farmaceutica”.
Nelle LINEE GUIDA DI REGOLAMENTO REGIONALE DELL’INFORMAZIONE SCIENTIFICA SUL FARMACO, approvate il 20 aprile 2006 dalla Conferenza delle Regioni e delle Province Autonome, al punto 6 si dice “It is not permitted for operators of the NHS and affiliated pharmacies to provide scientific representatives with information relating to the prescribing habits of doctors or information relating to the procedures for purchasing medicines”. The guidelines have been implemented in all the "Regional Regulations"
The Farmindustria Code of Conduct states that “It is part of the drug sales representative's activity to check and work to ensure the availability of the products both in pharmacies and at any other distribution point” and continues “L’informatore scientifico del farmaco non deve esercitare professioni aventi attinenza con l’utilizzazione del farmaco, anche se non remunerate, né alcun’altra attività continuativa che comporti il rapporto di lavoro subordinato”
AIFA also claims (Prot. AG/106373.P) that it emerges the importance of the activity of the ISF which, in order to focus attention on the social function of drugs in the protection of public health, must maintain a high degree of autonomy in carrying out the information service for doctors, with the aim of not be conditioned by purely private commercial interests.
So, going back to the initial requirement, i.e. whether ISFs are allowed to collect information about their drugs and their prescribers and collect orders, the answer is absolutely NO.
If an ISF is asked for such illegal behavior, he must obtain a written provision with which he must go to the Carabinieri of the NAS and report the matter in order not to become an accomplice in the offense or, worse, allow the company, if discovered, to place the blame on the FSI by indicating such behavior as an initiative of the FSI itself. A recent law (law 179/2017) introduces protection for employees of private companies who report to the supervisory bodies illicit or corrupt corporate behavior envisaged by the 231 organizational models.
In farmacia non ospedaliera pertanto l’ISF può assicurarsi che sia presente il farmaco della propria azienda e illustrare il Riassunto delle Caratteristiche del Prodotto (RCP), in sostanza il foglietto illustrativo. Null’altro.
Obviously we are talking about drugs prescribed by the doctor.
Editorial board
Related news: LAW 30 November 2017, n. 179