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.