Monthly Archives: November 2023

Corporate Liability Under Legislative Decree No. 231/2001: Latest Developments

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Recently, the regulatory framework of administrative liability of entities for criminal offences has been partially amended, by (i) recognizing its central role within the framework of public tenders’ regulations, and (ii) expanding the catalogue of predicate offences (reati presupposto or 231 crimes).

  • 231 Corporate Liability as Ground for Exclusion from Public Tenders

Legislative Decree no. 36/2023, i.e., the new Italian Public Tenders Code (“PTC”), distinguishes between causes of automatic exclusion (Section 94) and causes of non-automatic exclusion from public tenders (Section 95).

In case of:

  • a criminal conviction or disqualification measure for the criminal offences listed under Section 94, paragraphs 1 and 2, of the PTC issued against an economic operator under Legislative Decree No. 231/2001 (Section 94, paragraphs 3, lett. a) and 5), or
  • a disqualification sanction referred to in Section 9, paragraph 2, lett. c) of Legislative Decree no. 231/2001 (or of any other sanction entailing the prohibition to enter into agreements with public entities)

the sanctioned entity will be automatically excluded from the public tender.

Moreover, if a 231 crime is ascertained, or even only contested, then a “serious professional offence” is triggered, which may lead to a non-automatic cause of exclusion from the public tender (Section 98 of the PTC).

  • New 231 Crimes

Following the PTC, Law no. 137/2023 increases the number of 231 crimes by providing for the inclusion of the following criminal offences:

  • Obstruction of tender procedures (in Italian, “Turbata libertà degli incanti”, Section 353 of the Italian criminal code), i.e., hindering or disrupting a public tender or turning away bidders by violence, threats, gifts, promises, collusion or other fraudulent means;
  • Obstruction of the choice of contractor procedure (in Italian, “Turbata libertà del procedimento di scelta del contraente”, Section 353-bis of the Italian criminal code), i.e., disruption of the administrative procedure by way of violence or threats, or by gifts, promises, collusion or other fraudulent means, in order to influence the manner in which the public administration chooses a contractor; and
  • Fraudulent transfer of values (in Italian, “Trasferimento fraudolento di valori”, Section 512-bis of the Italian Criminal code), i.e., fictitious attribution of the ownership or availability of money, goods or other utilities for the purpose of avoid the application of the provisions of the regulation on asset prevention measures or smuggling, or of facilitating the commission of one of the offences referred to in Sections 648, 648-bis and 648-ter.

The novelties described above shows the Italian legislator’s increasing attention to the conduct of entities participating in public tenders, and will result in the need to review and update the 231 model already adopted by entities, in order to (i) provide for procedures to ensure correctness of the company’s conduct with specific regard to participation in public tenders, and (ii) take into account the three new 231 crimes.

Implementation of the “231” Compliance Model in the Pharma Industry: New Guidelines issued by the Italian Association of Pharmaceutical Companies

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On September 5, 2023, the Italian Association of Pharmaceutical Companies (“Farmindustria” – https://www.farmindustria.it/) has issued guidelines to design an organizational model pursuant to the Legislative Decree 231/2001 in the pharmaceutical sector (“Guidelines”).

In particular, the Guidelines, by taking into account the main peculiarities of the pharma industry, seek to identify the typical activities that are most at risk for the commission of criminal offences, and provide detailed guidance about the main policies and preventive actions that should be carried out by companies in order to prevent their commission.

As expected, the highest risks concern relationships with public officials, which may lead to crimes such as corruption or fraud against the State, with significant advantages for pharma companies.

The Guidelines seek to drive the attention of companies involved in the pharma sector on the risks that are latent in the following areas:

  • Relationships with healthcare professionals (“HCP”) and healthcare organizations (“HCO”): compliance programs should regulate activities of the key account managers and their bonuses, sponsorship of congresses, grants and donations to HCOs, gifts to HCPs, as well as other sponsorship or advertisement activities;
  • Relationships with Public Authorities: many interactions with public officials may entail corruptions risks, such as, e.g., obtainment of Market Authorizations, price reimbursement negotiations with the Italian drug regulatory agency (AIFA – https://www.aifa.gov.it/), management of site visits and inspections, participation and execution of public tenders for the supply of drugs to HCOs;
  • Relationships with private entities: relationships with suppliers providing services in the context of clinical studies, pharmacies, patient advocacy organizations, patients and “expert patients”, or management of patient support programs also need to be regulated.

The Guidelines also offer a complete set of policies and other preventive remedies that may be sufficient to prevent the envisaged criminal risks.

The Guidelines are a useful tool for pharma companies and no similar initiatives have been taken by other associations with regard to different industries and sectors. The Guidelines also constitute a benchmark for best practices that will be difficult to ignore.

Do you need help in designing or updating your company’s “231” compliance model? Do not hesitate to reach out!