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On November 15, 2017, the Italian Parliament approved a new law extending to the private sector the protection of employees who report unlawful behaviors of which they became aware during their work activities (so-called “Whistleblowers”). In this respect, Section 2 of the law states that Organization, Management and Control Models pursuant to Decree No. 231/2001 (“Law 231 Models”) shall provide for a whistleblowing system establishing (i) one or more channels for reporting unlawful conducts which may trigger the company’s liability pursuant to Decree No. 231/2001 and/or violations of the Law 231 Model and which must ensure the confidentiality of the whistleblower’s identity, and (ii) at least one alternative channel which shall also ensure, by electronic methods, the confidentiality of the whistleblower’s identity. Moreover, Law 231 Models shall prohibit any retaliatory or discriminatory actions against the whistleblower and provide for specific sanctions for the violation of such prohibition and for those individuals who report, with intent or gross negligence, untrue allegations. In view of the forthcoming entry into force of the above-mentioned provisions, all companies operating in sectors particularly exposed to legality distortive events, such as the pharmaceutical and the biomedical ones, should proceed with the update of their Law 231 Models.

 

Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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Giampaolo Austa is an associate at Baker & McKenzie in Italy.