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.