Prot.: 171017p 1996
Gentlemen Lawyer Emanuela Messina
Rome, 17 October 2017
Subject: ANSWER TO CONTRACTUAL INTERPRETATION QUESTIONS
Dear Doctor,
We report below the three questions you asked regarding the interpretation of the undersigned Trade Union Organization, as a signatory of the current CCNL for Pharmaceutical Chemistry, on some aspects concerning the scientific information activity of the drug.
Questions:
“Dica il sindacato, in riferimento al CCNL Chimico – Farmaceutico richiamato nel contratto di lavoro subordinato relativamente alla posizione individuale dell’informatore scientifico del farmaco:
a) If on the basis of the legislation in force and the National Collective Labor Agreement, the scientific representative of the drug is required to answer to the employer for the so-called sales data relating to your area of competence provided by a third-party company;
b) If, in the event that the so-called sales data are deemed by the company to be incongruous, i.e. not responding to company expectations, this could constitute a valid reason for the imposition of a disciplinary sanction or dismissal of the scientific representative of the drug;
c) Whether it is legitimate on the part of the company, in case of incongruity of the so-called sales data on the basis of company directives, have their scientific representatives carry out scientific tests, and, if positive, whether it is legitimate that there is no form of control over the correction of the documents by the workers, nor that the results are made available to drug sales reps employed by the company”.
Given that:
The National Collective Agreement for Pharmaceutical Chemistry regulates the figure of scientific information on drugs, considering it as envisaged by current legislation, an absolutely distinct activity from the commercial one, aimed at the "scientific" knowledge of drugs among all health professionals, and not directly connected to the commercial one.
This aspect is very clear, and can be seen by looking at the specific declarations of the various professional figures, of the commercial and marketing and sales functional area, which also includes the figure of scientific drug information, since the work organization indicated the CCNL does not provide for a Scientific Functional Area, as instead indicated in the relevant legislation.
The choice of placement of the ISF, within the commercial and marketing function, is linked only to a technical fact which sees some responsibilities of figures hierarchically superior to the scientific representative, in terms of relations with the external complex system, of both commercial and scientific; unfortunately all this has often created ambiguities in the attitudes of some companies, which increasingly tend to mix scientific information activities with commercial ones; if this is in some way made possible in the contract for hierarchically top organizational positions, it is absolutely not possible for the professional figure of the scientific informant.
Analizzando nel dettaglio il CCNL, in APPENDICE 1 / ART. 4 CCNL CLASSIFICAZIONE DEL PERSONALE / CATEGORIA A: FIGURE PROFESSIONALI PER AREA FUNZIONALE E POSIZIONE ORGANIZZATIVA 1, che tratta le attività delle figure apicali dell’azienda, vediamo che le figure professionali ai punti 3, 4, 6, 8, sono direttamente collegate alla vendita dei prodotti; confrontando ora le due figure professionali di Capi Area ai punti 7 e 8, emerge con assoluta chiarezza che, mentre la figura professionale 8 ( Capo aree di vendita ), agisce territorialmente in un Area geografica definita ed ha delle competenze prettamente commerciali, la figura 7 (Capo aree farmaceutico ) è invece responsabi- le di più aree geografiche, ed ha due responsabilità, ben distinte; infatti seppure collabora per definire strategie di vendita ed economiche, deve garantire lo svolgimento di una corretta informazione scientifica (…nel rispetto delle normative di legge vigenti in materia e delle norme deontologiche…….). Chiara, in questo caso, la volontà/necessità delle parti stipulanti di mantenere nettamente divise le due attività.
Proseguendo, sulla stessa APPENDICE 1, fino alla POSIZIONE ORGANIZZATIVA A3, alla posizione organizzativa 34 troviamo la figura di Capo Area (Farmaceutico ) chiaramente dedicato alla supervisione e coordinamento degli Isf, sempre e solo (…nel rispetto delle normative di legge vigenti in materia e delle norme deontologiche…….).
Continuing always in APPENDIX 1/ART. 4/ CATEGORY B/ ORGANIZATIONAL POSITION 1/ we find, marked with the number 64, we find the precise definition of the specific activity of the drug sales representative. Here too the observations for level A are repeated, even more decisively, i.e. while all the professional figures 61, 62, partially 63, 65 and 66, have commercial tasks and responsibilities, while the informant is completely and solely dedicated to the role of scientific information of the drug. And the parties stipulating the CCNL could have done nothing else but defer their duties to hierarchically superior sources such as Legislative Decree 219/06 which in turn implements specific European regulations. In fact figure 64 of the CCNL:
(…….Svolge, secondo le direttive aziendali e nel rispetto del D.Lgs. 30/12/1992 n. 541 come modificato dal D.Lgs. 24/04/2006 n. 219, attività di informazione scientifica presso i medici e gli operatori sanitari illustrando loro le caratteristiche, farmacologiche e terapeutiche dei farmaci al fine di assicurarne il corretto impiego.)
(……..riferisce all’impresa nel rispetto dell’art. 9, punto 6, del D.Lgs. 30/12/1992 n. 541 come modificato dall’art. 122, punto 6, del D.Lgs. 24/04/2006 n. 219, le osservazioni registrate nell’uso dei farmaci che emergono dal colloquio con gli operatori sanitari ed in particolare le informazioni sugli effetti secondari dei farmaci ad uso umano.)
The need and willingness to strictly comply with the legislation in force on the matter was a choice of the stipulating parties, through the references included in the CCNL.
The aforementioned Legislative Decree 12/30/1992 n. 541, has been superseded and replaced by Legislative Decree 24/04/2006 n. 219. The Legislative Decree 219/06 regulates the work of the ISF in a truly detailed and meticulous way, much more than a "job description"; From article 119 to art. 128 regulates the work of the ISF in all its operational aspects in the presence of healthcare professionals (doctor, pharmacist and hospital pharmacist). And the chemical-pharmaceutical collective bargaining agreement provides for each task in an equally detailed and meticulous way.
Nel dettaglio al richiamato, art.122, punto 6, ……… Gli informatori scientifici devono riferire al servizio scientifico di cui all’articolo 126, dal quale essi dipendono, ed al responsabile del servizio di farmacovigilanza di cui al comma 4 dell’articolo 130, tutte le informazioni sugli effetti indesiderati dei medicinali, allegando, ove possibile, copia delle schede di segnalazione utilizzate dal medico ai sensi del titolo IX.
While the contents of the aforementioned Legislative Decree 12/30/1992 n. 541, art. 9, point 6, concerning the pharmacovigilance topics listed below, have been inserted in TITLE IX of 219/06, which state:
Gli informatori scientifici devono riferire al servizio scientifico di cui all’art. 14, dal quale dipendono, tutte le informazioni sugli effetti secondari dei farmaci, allegando, ove possibile, copia delle schede di segnalazione utilizzate dal medico ai sensi dell’art. 1 del decreto del Presidente della Repubblica 25 gennaio 1991, n. 93. Art. 1.
“1. Le schede di segnalazione di effetti tossici e secondari, conseguenti o comunque correlabili all’impiego di farmaci, che tutti i medici curanti sono tenuti ad utilizzare per le comunicazioni alla unità sanitaria locale competente per territorio previste dall’art. 9 del decreto-legge 30 ottobre 1987, n. 443, convertito, con modificazioni, dalla legge 29 dicembre 1987, n. 531, devono essere conformi al modello che sarà approvato con decreto del Ministro della sanità obbligatoriamente entro trenta giorni dalla pubblicazione del presente regolamento.
2. Le imprese titolari di autorizzazione all’immissione in commercio di specialità medicinali, ivi comprese quelle prodotte all’estero, ed i produttori di farmaci galenici preconfezionati sono tenuti a fornire ai medici curanti un congruo numero di schede conformi al modello di cui al comma 1.
3. Esemplari di tali schede saranno, altresì, pubblicati dal Ministero della sanità nel Bollettino d’informazione sui farmaci.”
Answers:
Now, on the basis of the premises, it can be stated that, answering question (a), according to the Filctem CGIL signatory of the CCNL in question, there is no possibility of a direct link between the work of scientific information and the economic results of the product presented to healthcare professionals, indeed the will to clearly divide the sales activity and the economic results is clear, from the activity of scientific information, which has a purely and exclusively scientific nature, as defined in the contractual declarations and by the laws in force, indicated above.
Similarly, answering question (b), according to the Filctem CGIL it is not possible, given the declared contractual will analyzed above, to commensurate the professional performance of the informant, to the value of the economic and sales data of the products presented in one's geographical area pertaining to work; for this reason it is not possible to derive any sanction against the worker from the analyzes described above.
On the other hand, as regards the issue of training, posed to question (c), the company has the absolute right to promote initiatives aimed at improving the professionalism of scientific reps, whatever the objective data from which the training need arises, provided that the topics of the course in question pertain to the worker's activity, or are of a general nature; for example, it is clear that any specific training courses in sales and/or motivational techniques risk, unfortunately a very widespread fact, creating confusion in the role of the professional figure, inserting characteristics of a purely commercial nature in a context of absolute dichotomy between different functions. It is also not possible to harm the dignity of the individual by making a common comparison, of a plenary nature, or to correct individual documents, as the protection of the right to privacy must always be guaranteed.
Now, based on the premises, answering question (a), as regards the CCNL, according to Filctem Cgil, as a signatory of the CCNL in question, there is no possibility of a direct link between the work of scientific information on the drug among health professionals authorized to prescribe or dispense it and the economic results of the product presented to health professionals; on the contrary, there is a clear desire to clearly divide the sales activity and the economic results from the scientific information activity, which has a purely and exclusively scientific nature, as defined in the contractual declarations indicated above, in absolute compliance with current legislation.
In the same way, answering question (b), according to Filctem CGIL it is not possible, given the declared contractual will analyzed above, in implementation of the clear regulations of the Law, to commensurate the professional performance of the informant, to the value of the economic data and sale of the products presented in the geographical area of work pertinence; for this reason it is not possible to derive any sanction against the worker from the analyzes described above.
On the other hand, as regards the issue of training, posed to question (c), the company can/must promote initiatives aimed at improving the professionalism of scientific reps, whatever the objective data from which the training need arises, provided that the topics of the course in question pertain to the worker's activity, or are of a general nature; for example, it is clear that any specific training courses in sales and/or motivational techniques risk, unfortunately a very widespread act, creating confusion in the role of the professional figure, inserting characteristics of a purely commercial nature in a context of absolute dichotomy between different functions.
It is also not possible to harm the dignity of the individual by making a common comparison, of a plenary nature, or to correct individual documents, as the protection of the right to privacy must always be guaranteed. Indeed, we recall in this regard that, based on article 63 of the CCNL, the will to guarantee and increase timely and adequate training is clearly shared by all parties signing the CCNL, as it is considered essential for the company and for the worker.
This is also achieved through the appointment, by the Rsu, of the Training Delegate, who actively participates in the creation of shared training plans.
Hoping to have been clear and exhaustive, we remain at your disposal for any clarifications and/or clarifications, best regards.
p.The FILCTEM National CGIL Pharmaceutical Chemical Department
Sergio Cardinals
WITH WORKERS, ON THE SIDE OF CITIZENS
Il tavolo di confronto sulla farmaceutica aperto al ministero dello Sviluppo Economico, le normali relazioni con le associazioni imprenditoriali del settore, gli incontri istituzionali regionali, rappresentano momenti utili ed opportuni per effettuare questa verifica sullo stato dell’arte, ed al tempo stesso, utili a correggerne la deriva in corso.
Filctem-Cgil is in the field to bring out the problems and develop solutions necessary to relaunch the