Tag Archives: HCO

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

Legal news, , , , , , , , , , , , , , , ,

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!

EU Commission Factsheet on MDR and IVDR

Legal news, , , , , ,

Still confused about the regulatory changes affecting medical devices and in vitro devices? The EU Commission has published a useful factsheet, which you can find here.

Through the factsheet, the Commission warns health institutions and healthcare professionals that the upcoming changes may have consequences on the availability of medical devices because manufacturers may decide to stop their production or because products may not get their certificates on time.

Some notified bodies have also decided to drop off and only two notified bodies have been MDR designated so far, so this will create additional bottlenecks. A short grace period until 2025 is granted, but it does not apply to class I devices.

The path to an enhanced regulatory framework will be complicated and manufacturers, healthcare institutions and healthcare professionals need to know what to expect.