On 25 September 2014, a FEDAIISF delegation made up of the National President Fabio Carinci, the National Secretary Riccardo Bevilacqua and the Secretary of the Frosinone and Latina Section Antonio Setale met the AIFA Director General Prof. Luca Pani in Rome.
The topics covered by the meeting were submitted to AIFA, in the letter that FEDAIISF sent to the Secretary, dated 29 August 2015 (ProtU64/14/FC )
At the end of the meeting they were delivered to prof. Luca Pani two letters (ProtU66/14/FC and ProtU67/14/FC) containing some questions concerning the profession of Scientific Pharmaceutical Representative.
In addition, two FEDAIISF 2015 booking diaries were delivered to AIFA, containing the booking regulations and the association's Code of Conduct.
As regards the outcome of the meeting, postponement to a date after the publication of the minutes
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FEDAIISF Federation of Italian Associations of Pharmaceutical Representatives
President
ProtU64/14/FC
Rome, August 29, 2014
Dear Dr Silvia Cammarata
AIFA General Directorate
ROME
openaifa@aifa.gov.it
Object: FEDAIISF – Open AIFA meeting on 25 September 2015
Dear Doctor,
with reference to our last telephone conversation, I would be grateful if you would submit to Mr. General Manager Prof. Luca Pani the topics we intend to address in the conversation granted as part of the "open-AIFA" initiative on 25 September next. The problems can be summarized as follows:
1- Repeated signs tending to consider the Scientific Representative of the drug, a cost to be reduced, while on the contrary training of the ISF is necessary independently of the company one.
2- Adjustment of companies to comply with law n.219/2006, contractual renewals contra legem: AIFA supervision. For this purpose, please refer to the clarifying letter from the previous Director, Nello Martini, reported on page 100 of the ISF Vademecum (published on the website www.fedaiisf.it – fedaiisf – publications – ISF Vademecum part 2 ) where it is reiterated that the ISF does not have a purely commercial function, but of scientific updating information and, depending on a scientific and non-commercial service, even excludes contractual forms of agency whose remuneration is exclusively based on the sale. The then director Nello Martini was referring to Legislative Decree 541, which is substantially identical to Legislative Decree 219/06 (IMPLEMENTATION OF DIRECTIVE 2001/83/EC - AND SUBSEQUENT AMENDMENT DIRECTIVES - RELATIVE TO A COMMUNITY CODE CONCERNING THE MEDICINAL PRODUCTS FOR HUMAN USE, AS WELL AS OF DIRECTIVE 2003/94/EC) in which it was incorporated.
He wonders if AIFA has changed its attitude towards the law and what it intends to do in the event of modification of the same.
3- In-depth analysis of the mobility requests of pharmaceutical companies, also in the light of the new decree and the criminal relevance of any false accounting.
4- Moral objectives of the doctors and managers of the Italian AUSL. Cash prizes to promote generic medicines.
I thank you in advance for your cordial attention and I welcome the opportunity to send you my best regards. With much cordiality
Fabio Carinci National President
FEDAISF
e-mail: fabiocarinci45@gmail.com mobile: 348 0646157
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FEDAIISF Federation of Italian Associations of Pharmaceutical Representatives
President
ProtU67/FC/14
Rome, 23 September 2014
egr. Prof. Luke Pani
AIFA General Manager
Italian Medicines Agency – ROME
Object: sentence of the Court of Cassation 19394/2014 15/09/2014 – The ISF is not a commercial agent
– Prof. Nello Martini, former AIFA General Manager, considered the scientific information activity on the drug not dependent on the Commercial Management, but on the Medical Management of the same Companies (prot. N.800.1/IS/9573 of 19 August 2002);
-all the articles relating to pharmaceutical information contained in Legislative Decree 219/06 tend to this statement, and AIFA is the supervisory body so that all this takes place in full compliance with the law;
– in the light of the recent sentence of the Court of Cassation 19394/2014 15/09/2014 which establishes that the scientific representative of the drug is not a commercial agent, we ask you:
1) Is it legitimate for companies to ask their ISFs to have average visits, frequency and coverage of the territories, to target doctors for a higher (or lower) frequency of visits according to their prescriptive capacity?
2) Other professional figures (area managers and local doctors) can carry out scientific information activities, in particular for drugs with MA, since they are not included in the lists that companies submit to AIFA (by January of the following year ) which declares the number of informants employed, in the previous year, for scientific information?
3) What role does AIFA foresee for the area heads? Is support to the ISF lawful, even in the absence of regional regulations governing its activity? In fact, all the regions that have adopted a scientific information regulation explicitly forbid the assistance of the Area Managers to the ISF”.
4) Is it legitimate to use the ISF for market surveys in order to detect the prescribing potential of doctors and/or hospital departments to optimize promotional actions?
5) Has AIFA ever verified, even through an audit in Pharmaceutical Companies, the real dependence of the ISF on the Scientific Service? Paying attention not to be deceived by the dependence deriving from organizational reasons of the company personnel.
6) Should Pharmaceutical Companies keep a line of information on basic medicine, even on expired patent products, in relation to a scientific update and the pharmacovigilance service?
Waiting for a kind reply, I send you my best regards.
Fabio Carinci
FEDAIISF President
e-mail: fabiocarinci45@gmail.com mobile: 348 0646157
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FEDAIISF Federation of Italian Associations of Pharmaceutical Representatives
President
ProtU66/FC/14
Rome, 22 September 2014
egr. Prof. Luke Pani
AIFA General Manager
Italian Medicines Agency – ROME
Object: art. 119, paragraph 6, Legislative Decree 219/06
Given that, as provided for by article 48, paragraph 2 of law 326/03: “it being understood that the drug represents a tool for the protection of health, the Italian Medicines Agency was established with effect from 1 January 2004", "it (paragraph 3) is responsible for tasks in the field of medicines policies (also) with reference to scientific information" and that Legislative Decree Legislative Decree 219/06, in article 122, paragraph 6, establishes that the scientific reps depend on the Scientific Service of the Company and that (Article 126, paragraph 1) "The Scientific Service must be independent from the Marketing Service of the pharmaceutical company"
you ask to know
what is the Agency's position regarding the illicit innovation contained in the latest National Collective Labor Agreement of the Chemical Industry, signed in 2012, in the part which provides for the classification of scientific representatives in the Commercial/Sales Area, in disregard of the aforementioned articles of Legislative Decree 219/06,
and if the same Agency deems applicable
to defaulting companies, the penalties provided for by art. 119, paragraph 6, of the aforementioned Legislative Decree 219/06 which states: "If the promotional information to healthcare professionals is carried out in violation of the provisions and criteria and directives adopted by AIFA pursuant to paragraph 2, the The Agency itself orders the immediate cessation or suspension of the promotional information”.
also according to the clarifications already provided by the Ministry of Health (19/8/2002 n.15): "the informant can only depend on the figure of the scientific manager"
and another, given in response to a parliamentary question (4/16726 On. Maceratini. 7/12/1993):
"Such an obligation, which entails the onset of a specific legal liability "in surveillance" by the same legal representatives of pharmaceutical companies, even in the event of non-compliance with the law on the matter, in any case attributable to their fault, could a fortiori make it configurable against them a case of "continued infringement" (and as such of greater gravity with respect to the possible purposes of article 14 [*], paragraph 1 of Legislative Decree 541/92) when the usual organization of the Scientific Service according to criteria which are in themselves incompatible with the constraints imposed on information on drugs is proven, by contradiction.
[*] Subsequently replaced by Article 126 of Legislative Decree 219/06 (ed)
Attachment 1: Text of the articles cited, Attachment 2: Ministerial responses
While waiting to hear AIFA's position on the questions raised, I send you my best regards.
Fabio Carinci
FEDAIISF President
e-mail: fabiocarinci45@gmail.com mobile: 348 064615
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