Anti-Corruption Enforcement and Defense in the EU

Transcription

1 Anti-Corruption Enforcement and Defense in the EU The Fifth International Pharmaceutical Compliance Congress and Best Practices Forum Istanbul, Turkey, May 4, 2011 Federico Busatta, Gianni, Origoni, Grippo & Partners (Milan) Eugenio Fusco, Senior Public Prosecutor (Milan) Kai-Hart Hoenig, Former Public Prosecutor (Frankfurt) Marco Sugarelli, Senior Legal Director, Pfizer Italia (Rome) Gary F. Giampetruzzi, Pfizer Legal Division (moderator)

2 Agenda Current trends in healthcare prosecutions in the EU Prosecutors and Defense Counsel views Intersection of prosecution /compliance programs What value is there in preventing prosecutions? What value is there in mitigating the severity of the outcome? What does an effective compliance program generally look like to prosecutors in the EU? What is most important, and does it make a difference? What types of compliance measures are companies putting into place in the aftermath of prosecution? What does the future hold? 2

3 Current trends in healthcare prosecutions in the EU A case of successful prosection brought by the Milan Public Prosecutor s Office: - This office investigated and arrested the CEO of the Italian branch of a US listed healthcare company; - The SEC, duly informed about this investigation, required the US company to provide relevant information; - Upon instructions from the SEC, relevant information was also shared with the Milan Public Prosecutor s Office; - Both the companies and the relevant individuals involved were found guilty of charges of corruption;

4 If the Public Prosecutor proves that an alleged illicit payment has been made by an employee within the top management, what should the company prove in order not to be held liable? According to the relevant Italian statute, in such a case the entities involved would not be held liable should they prove that: a) they adopted and effectively enforced, prior to the commission of the illicit payment, a compliance program which aims at preventing such crimes; b) they appointed an internal compliance monitoring function (with autonomous powers of initiative and control) to supervise the enforcement and update of the compliance program; c) the alleged illicit payments were made by the top management by eluding - fraudulently - the compliance program; or d) that the internal compliance monitoring function was not in default by omission or failure (insufficiencies) in its supervisory activities.

5 If the Public Prosecutor alleges that an illicit payment has been carried out by an employee who is subordinate to the top management, how does the burden of prove work? In the case of an illicit payment allegedly made by an employee subordinate to the top management, the public prosecutor has a stricter burden of proof in orde to argue the existence of corporate liability; The public prosecutor has the burden to prove that the alleged illicit payment was possible due to the company s failure to comply with management or supervisory obligations of the employee s activities; The company can disprove such circumstances by proving to have adopted, and effectively applied, an adequate compliance program prior to the alleged illicit payment;

6 Is it true that confiscation orders can be issued, under Italian law, even if the company is acquitted of corruption charges? As a general rule, if the entity is found to be liable and convicted for illicit payments made by employees, the Court will issue a confiscation order concerning the price or profit of the alleged crime, also in an amount of money, goods, or other utilities equivalent to the value of the price or profit of the crime; To prevent the entity from benefiting from an illicit payment made by an employee in its interest or to its advantage, a confiscation order can be issued by the Court even if the entity has not been found to be liable as it has proved to have developed/enforced a compliance program, etc. (see slide 4); A confiscation order can be issued regarding the (lawful) profits gathered by the entity as a consequence of the business carried out under the supervision of a receiver ( commissario ) appointed by the Court to lead the company under the relevant statutes;

7 Is it possible for the company to seek that the enforcement of an applied interim measure is put on hold? Under Italian law, the enforcement of an interim measure against an entity can be put on hold if the entity offers: - to pay damages or otherwise demonstrates to have made all the efforts possible for that purpose; - to adopt and enforce a compliance program with the purpose to prevent future possible illicit payments; - to disgorge the profit made out of the illicit payment, so that such profits can be confiscated. The court could, in this case, suspend the enforcement of the interim measure, setting a bail.

8 THE END / YOUR QUESTIONS 8