Tag Archives: farmindustria

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!

An Update on the Latest Amendments to the Italian Pharma Industry Association’s Code of Ethics

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Amendments to the Italian pharmaceutical industry association’s (Farmindustria) Code of Ethics have been introduced on January 19, 2022 https://www.farmindustria.it/app/uploads/2018/06/2022-GENNAIO-19.pdf.

One of the most important changes concerns section 4.7, which defines Patient Support Programs (PSP) as initiatives implemented by pharmaceutical companies aimed at making available additional services for the direct benefit of patients. Such services are not intended to replace the services of hospitals and other healthcare organizations. For more information on PSP, check out our previous blog post https://lawhealthtech.com/2022/02/07/new-guidelines-on-patient-support-programs-adopted-by-italian-pharma-industry-association/ .

Besides, other important amendments have been introduced:

  • Training and Information to Non-Prescribers: new section 3.25 (i) allows pharmaceutical companies to carry out training and information activities aimed at healthcare professionals who are not authorized to prescribe medicines, but are involved in the treatment management, provided that such activities do not have any promotional purpose and that the information provided is linked to their roles in patients’ treatment management; and (ii) extends to such professionals the possibility to attend events, courses and congresses, as long as such events do not concern topics relating to medicines;
  • Information to the Public: new section 3.26 (i) allows pharmaceutical companies to provide unsolicited information to the public, through personnel not belonging to commercial or marketing areas, relating to products and diseases pertaining to the relevant therapeutical area, provided that such information does not have a commercial nature and matches the information set forth in the package leaflet or institutional information channels; and (ii) confirms that a full literal reproduction of the package leaflet information may be published on the companies’ websites available to the public;
  • Interactions Other than Medicines Promotion: new section 3.28 (i) allows pharmaceutical companies to provide information on medicines to various stakeholders such as institutions, professionals, organizations, etc., without this falling within the scope of medicines promotion; and (ii) specifically regulates the possibility to carry out, during the medicine’s life cycle, institutional and market access activities or other non-promotional interactions towards institutions and health care professionals, as well as account management activities aimed at ensuring the application of commercial policies through interactions with public or private counterparties involved in the medicines procurement processes and activities aimed at the mutual sharing of non-promotional information and data.

The above new provisions of the industry Code of Ethics undoubtedly aim at regulating several aspects of the day-to-day promotional and educational activities of pharmaceutical companies that have been so far ignored by the industry association regulations. However, the new previsions are quite vague in their scope and it remains to be seen whether they will have any meaningful impact on the market practices in the pharmaceutical sector.

New Guidelines on Patient Support Programs Adopted by Italian Pharma Industry Association

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New guidelines on patient support programs have been adopted by the Italian pharmaceutical industry association (Farmindustria) on January 19, 2022. The new guidelines have been incorporated in a new release of the industry ethical code, where also several provisions regarding educational activities, market access and scientific data exchange have been updated.

Patient support programs are not expressly regulated under Italian law and, for such reason, the guidelines issued by Farmindustria are particularly helpful in identifying the best market practices. The new guidelines define patient support programs as initiatives implemented by pharmaceutical companies aimed at making available additional services for the direct benefit of patients. Such services are not intended to replace the services of hospitals and other healthcare organizations.

Patient support programs can only be implemented in connection with medicinals that have received a marketing authorization, for the sole purpose of providing information on the correct use of the medicinal product and to foster patients’ compliance with its administration. They can never have a promotional purpose.

The new Farmindustria guidelines expressly acknowledge that patient support programs may be implemented by pharmaceutical companies through a third party service provider, which may carry out services in favour of patients by means of adequately qualified professionals. The pharmaceutical companies, however, continue to have overall responsibility for the program.

A noteworthy innovation has been adopted with regard to the processing of patients’ personal data. In fact, the new guidelines provide that pharmaceutical companies must not directly process the data of patients enrolled in a patient support program, and should rather only access aggregated data for statistical purposes on the use of the services. 

This latter provision is particularly troublesome from a data protection standpoint, as it may be interpreted as preventing pharmaceutical companies from acting as data controllers in connection with the deployment of patient support programs, even if they remain responsible for the programs themselves. Therefore, new mechanisms shall be implemented to segregate identifiable data and prevent their processing by pharmaceutical companies unless they are previously de-identified.