The pharmaceutical sector was one of the most responsive to the innovations introduced by Legislative Decree 231/01 and today, by virtue of the greater sensitivity on the subject, the spotlights are focused on the construction of adequate organizational models, the only tool capable of avoiding the criminal liability of legal persons
Thursday 2 October 2014 – HPS Aboutpharma
The pharmaceutical sector has been among the most reactive to the innovations introduced by Legislative Decree 231/01 and today, by virtue of the greater sensitivity on the subject, also following various legal proceedings involving some companies producing or distributing medicines, the spotlights are on the construction of adequate organizational models, the only tool capable of avoiding the criminal liability of legal persons and the consequent risk of application of heavy criminal, pecuniary and disqualification sanctions, against the company.
The sector experts who will participate in the conference anticipate some sensitive issues:
“È essenziale la ‘leadership’, ossia la ferma volontà dei vertici aziendali di favorire la diffusione di valori etici. Poi la fase del ‘risk assessment’, durante la quale i legali incaricati della redazione del modello organizzativo realizzano un’analisi approfondita dei rischi di commissione di reati. L’adozione di ‘standards and controls’. Si procede alla stesura dei protocolli necessari ai fini della regolamentazione delle aree a rischio. Mancano, in realtà, due momenti fondamentali: la fase ‘communication and training’, ovvero la diffusione del documento ai dipendenti e, in ultimo, la fase del ‘monitoring’”.
Maria Gloria Boni, Member of Supervisory Bodies, specifies the role of a supervisory body in the application of 231/2001:
“In prima battuta si verifica il livello di trasparenza di un’impresa, non meno importante la funzione consultiva che si esplica quando la dirigenza richiede un parere anticipato sulla compliance di un’operazione aziendale. L’organismo di vigilanza viene interpellato per le analisi di rischio, esamina il livello di aderenza del modello di gestione dell’impresa al 231 e può chiedere che il modello venga aggiornato o integrato. Nella valutazione l’organismo deve tener conto della complessità organizzativa di alcuni gruppi aziendali. Oltre all’attività di controllo svolge una funzione di interfaccia, attraverso i flussi informativi che andrebbero ottimizzati in base ai report che la società è in grado di fornire”.
Aurelio Giovanelli, partner of the Baker & McKenzie studio, indicates strong similarities between the various regulations (the 231 in Italy, the British Bribery Act and the US FCPA), but also the differences:
Article 5
Responsibility of the entity
1. The entity is liable for crimes committed in its interest or to its advantage:
a) da persone che rivestono funzioni di rappresentanza, di amministrazione o di direzione dell’ente o
of one of its organizational units with financial and functional autonomy as well as by people who
exercise, even de facto, the management and control of the same;
b) by persons subject to the management or supervision of one of the persons referred to in letter a).
2. L’ente non risponde se le persone indicate nel comma 1 hanno agito nell’interesse esclusivo
own or third party.
Article 6
Persons in top positions and organization models of the entity
1. Se il reato è stato commesso dalle persone indicate nell’articolo 5, comma 1, lettera a), l’ente non
responds if it proves that:
a) l’organo dirigente ha adottato ed efficacemente attuato, prima della commissione del fatto,
organization and management models suitable for preventing crimes of the type that occurred;
b) the task of supervising the functioning and observance of the models and taking care of them
aggiornamento è stato affidato a un organismo dell’ente dotato di autonomi poteri di iniziativa e di
check;
c) the persons committed the crime by fraudulently eluding the organization and
management;
d) there has been no omission or insufficient supervision by the body referred to in letter b).
2. In relazione all’estensione dei poteri delegati e al rischio di commissione dei reati, i modelli di cui
under letter a), of paragraph 1, must meet the following requirements:
a) identify the activities in which crimes may be committed;
b) prevedere specifici protocolli diretti a programmare la formazione e l’attuazione delle decisioni
dell’ente in relazione ai reati da prevenire;
c) identify ways of managing the financial resources suitable for preventing the commission of
crimes;
d) establish information obligations towards the body responsible for supervising the
operation and observance of models;
e) introduce a disciplinary system suitable for sanctioning failure to comply with the measures indicated
in the model.
3. The organization and management models can be adopted, guaranteeing the requirements referred to in
paragraph 2, on the basis of codes of conduct drawn up by the associations representing the entities,
communicated to the Ministry of Justice which, in agreement with the competent Ministries, can formulate,
within thirty days, observations on the suitability of the models to prevent crimes.
4. In small entities, the tasks indicated in letter b), of paragraph 1, may be
svolti direttamente dall’organo dirigente.
4-bis. In corporations, the board of statutory auditors, the supervisory board and the committee for the
controllo della gestione possono svolgere le funzioni dell’organismo di vigilanza di cui al comma 1,
letter b) (1).
5. È comunque disposta la confisca del profitto che l’ente ha tratto dal reato, anche nella forma per
equivalent.
(1) Paragraph inserted by article 14, paragraph 12, of Law 12 November 2011, n. 183, starting from 1 January 2012, ai
pursuant to article 36, paragraph 1, of the same Law 183/2011
Ed.: companies usually make informants sign acknowledgment of the laws in force on corruption. In this way, whatever illegal thing happens, even on the orders of the Area Manager or some other senior figure, the responsibility falls solely and exclusively on the ISF. In fact, the signature on that document shows that the company has informed the ISF and therefore, even if he has "obeyed" his superiors, the company is not responsible, unless there is a written document demonstrating that he has been instigated to commit a crime.
In cases of "instigation", the ISF should denounce the superior for the crime it would like him to commit. In the absence of a register or some other form of protection, it is easy to say, but ...