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In brief

On January 19, 2022, Farmindustria published an updated version of its Code of Conduct introducing relevant changes on Patient Support Program (“PSPs”).

Key Takeaways

In particular, according to the updated version, PSPs are defined as the provision of services by a pharmaceutical company for the direct benefit of the patient, in addition to those provided by healthcare institution or the National Health Service (NHS). The updated version also amends the rules governing the processing of personal data belonging to patients involved in PSPs by providing that pharmaceutical companies cannot be involved in the processing of such data and establishes that the duration of services provided within PSPs must be defined in advance and in line with the identified need of, and the relevant desired benefit for, the patient.

In more detail

Moreover, the following three sections have been added to the Code of Conduct: (i) Section 3.25, allowing pharmaceutical companies to carry out training and information activities for the benefit of non-prescribing doctors involved in the administration of therapies, provided that said activities do not have promotional purposes nor refer to drug-related issues; (ii) Article 3.26, introducing the possibility for pharmaceutical companies to provide the general public with information on drugs and diseases falling within the therapeutic areas on which they focus, provided that the relevant information is of a non-commercial nature and is taken from the package leaflet, institutional websites or registers managed by public bodies; and (iii) Article 3.28, which provides clarification on interactions of an informative nature between pharmaceutical companies and other stakeholders (institutions, healthcare and non-healthcare professionals and healthcare organizations) and which do not fall within the scope of the regulation governing the promotion of medicinal products.


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.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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